Disinfection system for reusable medical instruments

Abstract

To provide a disinfection system for reusable medical instruments.SOLUTION: A disinfection system includes a disinfection chamber and a disinfection device. The disinfection chamber has an interior volume, a plurality of radiation sources, which, when enabled, output a disinfecting radiation, at least one disinfection chamber registration feature, and a disinfection chamber controller arranged to perform a disinfection process via enablement of the plurality of radiation sources. A disinfection tray device has a UV-transparent tray structure, the UV-transparent tray structure having a multi-compartment receptacle shaped to align and contain a certain type of target article to be disinfected.SELECTED DRAWING: Figure 1B

Description

[Technical field]

[0001] The present disclosure relates generally to devices and systems for disinfecting targets. More particularly, but not exclusively, the present disclosure relates to systems, devices, and methods for containing targets during an ultraviolet radiation disinfection cycle. [Background technology]

[0002] Proper disinfection or sterilization of reusable medical equipment is important in preventing person-to-person transmission of pathogenic microorganisms. The level of disinfection and sterilization applied to medical equipment is determined according to the classification of the device. The Centers for Disease Control and Prevention (CDC) classifies medical equipment as critical, semi-critical, or non-critical items according to the intended use of the device (CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008). The CDC Guideline states that critical items pose a high risk of infection if contaminated with any microorganism.

[0003] Examples of critical items are devices that come into contact with sterile tissue, including surgical instruments, implants, and ultrasound probes used within sterile body cavities. These devices must be sterilized before use.

[0004] Semi-critical items typically come into contact with mucous membranes or non-intact skin. Examples of semi-critical items include devices such as probes used in vaginal, rectal, and transesophageal ultrasound, respiratory therapy and anesthesia equipment, and certain endoscopes. These medical devices should be completely free of microorganisms, although some small number of bacterial spores are considered acceptable. Semi-critical items require at least high-level disinfection (HLD).

[0005] Non-critical items are those that come into contact with intact skin (e.g., blood pressure cuffs and stethoscopes). In contrast to critical and some semi-critical items, most non-critical reusable items may be decontaminated when used to achieve intermediate or low levels of disinfection, and these items generally do not need to be transported to a central processing area for use.

[0006] Critical items are generally subjected to a sterilization process to kill and remove all microorganisms, since contamination with any microorganism poses a high risk of infection. Similarly, semi-critical items require high-level disinfection (HLD) when the pathogen population level is reduced to a very low level before or between uses. Some common methods for achieving sterilization or high-level disinfection include treatments using steam disinfection and / or chemical disinfection. When the object to be treated is heat-sensitive, chemical treatments are often used, and suitable chemical disinfectants for use in sterilization or disinfection of medical devices include, for example, glutaraldehyde, hydrogen peroxide, orthophthalaldehyde, and peracetic acid with hydrogen peroxide. Currently, some common methods for achieving high-level disinfection of semi-critical medical devices include immersing the device in a chemical bath. Chemical bath methods for semi-critical items may include immersion for a shorter period of time than that required to ensure complete sterilization.

[0007] Sterilization and disinfection processes that utilize steam or chemical treatment, while effective, have drawbacks. For example, the high temperatures associated with steam sterilization can damage the instruments being sterilized. In addition, the chemicals used for chemical sterilization or disinfection often have high costs for proper storage and disposal, and the toxicity of these chemicals can pose a risk to handlers. Furthermore, chemical methods and high temperatures (i.e., harsh heating to high temperatures in steam) systems can cause degradation of materials used to make the medical device being treated. Steam or chemical-based processes can also be time-consuming, with some procedures taking 15-40 minutes to complete, and these procedures typically require the instrument or device to be transported to a central location for treatment and then returned to the clinical environment. The medical device will be unavailable for such long treatment times, which can be a serious problem if the device is to be used in a critical care environment. Factors such as these can result in non-compliance with sterilization or disinfection procedures recommended by the Food and Drug Administration.

[0008] Several companies provide devices and systems that can achieve high-level disinfection of reusable targets in a short time, at low temperatures, and in situ within a clinical environment. For example, U.S. Patent No. 9,364,573, incorporated herein by reference, provides a disinfection method and system using a disinfection chamber with a radiation source, where high-level disinfection is achieved within 10 minutes (i.e., 600 seconds or less). The temperature in the disinfection chamber is maintained at a low level. One or both of the ambient temperature in the disinfection chamber and the surface temperature of the target to be disinfected are monitored to ensure that a threshold temperature is met and not exceeded, such as, for example, anywhere between 35°C and 55°C. As another example, U.S. Provisional Patent Application No. 62 / 776,974, incorporated herein by reference, teaches modeling of various parts of a disinfection system and target to assist in high-level ultraviolet disinfection. In at least some examples, devices, systems, and methods are provided for effectively determining and controlling disinfection exposure from ultraviolet radiation achieved in a disinfection chamber to achieve a minimum exposure (i.e., a minimum dose) to radiation on each surface portion of the target to be disinfected.

[0009] Not all of the subject matter discussed in the Background section is necessarily prior art and should not be considered prior art merely because it is discussed in the Background section. In accordance with that notion, any recognition of a problem in the prior art that is discussed in the Background section or that is related to the subject matter of that section should not be considered prior art unless it is expressly stated to be prior art. Rather, any subject matter discussed in the Background section should be considered to be part of the inventor's approach to a particular problem of that subject matter that may itself be considered inventive. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] U.S. Patent No. 9,364,573 [Patent Document 2] U.S. Provisional Patent Application No. 62 / 776,974 [Non-patent literature]

[0011] [Non-Patent Document 1] CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Summary of the Invention [Means for solving the problem]

[0012] The following is a summary of the disclosure to provide an introductory understanding of some features and context. This summary is not intended to identify key or critical elements of the disclosure or to delineate the scope of the disclosure. This summary presents some concepts of the disclosure in a simplified form as a prelude to the more detailed description presented below.

[0013] The device, method, and system embodiments described in this disclosure (i.e., the teachings of this disclosure) improve the high-level disinfection (HLD) process. In at least some embodiments, a disinfection tray system is formed having a tray portion with an integrated receptacle. Some or all parts of the tray portion are formed from a material that allows ultraviolet (UV) radiation to pass through (i.e., a UV-transparent material). Some or all parts of the disinfection tray system may also be UV-transparent. The integrated receptacle is positioned in a manner to fully or partially contain the target object to be disinfected. When the disinfection tray system and the target object to be disinfected are placed in a disinfection chamber, UV radiation emitted into the chamber impinges on the target object, thereby performing disinfection. A portion of the UV radiation is delivered directly from the UV source to the surface of the target object, and a portion of the UV radiation passes through the UV-transparent material of the disinfection tray system.

[0014] Optionally, embodiments of the sanitization tray system may include alignment features. The first alignment feature, if included, may be used to align the target object in the sanitization tray portion. The second alignment feature, if included, may be used to align the sanitization tray system in the sanitization chamber. Optionally, embodiments of the sanitization tray system may include an electronics module. The electronics module, if included, may be arranged to communicate with the sanitization chamber, provide a user interface, and enable other smart features. Optionally, embodiments of the sanitization tray system may further include any one or more of a handle, cover, case, and compartment, etc.

[0015] In some examples, a suitable disinfection chamber may be configured as a permeable disinfection chamber. In these examples, the disinfection chamber may be disposed within a wall or other barrier structure, the disinfection chamber may provide a first access (e.g., a first door) located on the non-clean side of the barrier for inserting the disinfection tray system, and the disinfection chamber may provide a second access (e.g., a second door) located on the clean side of the barrier for removing the disinfection tray system. In this manner, a first medical practitioner handling contaminated or other targets to be disinfected can place the targets in the disinfection tray, insert the disinfection tray system into the disinfection chamber, and begin the disinfection cycle. Another medical practitioner handling the disinfected targets can remove the disinfection tray system from the disinfection chamber after completion of the disinfection cycle.

[0016] This summary is provided to introduce in a simplified form some concepts that are described in more detail in the Detailed Description section. This summary is not intended to limit the scope of the claimed subject matter; rather, the language in the claims themselves will determine the scope of the claimed subject matter.

[0017] This description discusses a disinfection system for reusable medical instruments. The disinfection system comprises: 1. A sterilization chamber comprising: An inner volume, at least one radiation source that outputs UV disinfection radiation when enabled; and A sterilization chamber controller configured to perform a high-level sterilization process by enabling at least one radiation source. a sterilization chamber having a a UV-transmissive receptacle device for allowing at least a portion of at least one instrument to be sterilized to be placed in a position adapted for high-level disinfection; Equipped with.

[0018] According to some particular embodiments, the disinfection system comprises one or more of the following features: The sterilization device further comprises a plurality of radiation sources. The sterilization device further comprises at least one sterilization chamber alignment feature. The sterilization device further comprises at least one sterilization tray alignment feature configured to cooperate with the at least one sterilization chamber alignment feature when the sterilization tray device is placed within the sterilization chamber. At least one sterilization tray alignment feature is a non-electronic physical structure. Proper alignment of the sterilization tray device within the sterilization chamber is indicated by tactile feedback. At least one sterilization tray alignment feature is an electronic alignment feature. Proper alignment or misalignment of the sterilization tray device within the sterilization chamber is indicated by an audio and / or visual output. The sterilization chamber is configured to hold multiple sterilization devices simultaneously. The sterilization tray device is configured to align and contain at least the target instruments to be sterilized. The disinfection chamber device comprises: Doors and a door sensor, wherein the sterilization chamber controller is configured to determine when a door is closed, and the sterilization chamber controller is further configured to prevent and pause the sterilization process if the door sensor indicates that the door is open; It further comprises: The disinfection chamber device comprises: The second door, a second door sensor, wherein the sterilization chamber controller is configured to determine when both the door and the second door are closed, and the sterilization chamber controller is further configured to prevent and pause the sterilization process when the door sensor indicates that the door is open or when the second door sensor indicates that the second door is open; It further comprises: The disinfection chamber device comprises: a first door lock mechanism configured to lock and unlock the door; a second door lock mechanism configured to lock the second door and configured to unlock the second door, wherein the sterilization chamber controller: determining a pre-disinfection state, the pre-disinfection state being a first time before the start of a disinfection process; determining a current disinfection state, the current disinfection state being a second time at which a disinfection process has been initiated but not completed; determining a post-disinfection state, the post-disinfection state being a third time upon completion of the disinfection process; and Unlocking the door during the pre-disinfected state; locking the second door during the pre-disinfection state; and locking both the door and the second door during the current disinfection state; Locking the door during the post-disinfection state; Unlocking the second door during the post-disinfection state a second door lock mechanism configured to It further comprises: The sterilization chamber is integrated into the wall. A first side of the wall has a door and an opposing second side of the wall has a second door, the first side of the wall being a pre-disinfected side of the wall and the opposing second side of the wall being a post-disinfected side of the wall. The sterilization device further comprises a sterilization controller configured to communicate identification information to the sterilization chamber controller, the identification information being indicative of at least one of the UV-transparent structure and the particular type of target object to be sterilized. The sterilization chamber controller is further configured to select a sterilization process from the plurality of sterilization processes based on the identification information. The sterilization chamber controller is further configured to control the sterilization process based on the identification information. The sterilization chamber controller is further configured to selectively enable a first radiation source among the plurality of radiation sources and simultaneously disable a second radiation source among the plurality of radiation sources during the sterilization process based on the identification information. The sterilization chamber controller Generate metadata based on the disinfection process, Communicating at least a portion of the metadata to a remote computing device The method is further configured as follows. The metadata comprises user identification information representing the identity of the user who initiated the sanitization process. The metadata comprises timestamp information representing the date when the sterilization process was performed. The sterilization chamber controller is further configured to generate expiration data associated with the sterilization process. The sterilization device further comprises at least one electronic radiation sensor integrated into a surface of the sterilization device. The sterilization chamber controller is further configured to disable the at least one radiation source based on information from the at least one electronic radiation sensor. The disinfection device is a first electronic radiation sensor integrated into a surface of the sterilization device at a first location proximate the first receptacle portion of the UV-transmissive structure; a second electronic radiation sensor integrated into a surface of the sterilization device at a second location proximate the second receptacle portion of the UV-transmissive structure; and It further comprises: The sterilization chamber controller selectively enabling and disabling a first radiation source from among the plurality of radiation sources based on information from the first electronic radiation sensor; Selectively enabling and disabling a second radiation source from among the plurality of radiation sources based on information from a second electronic radiation sensor. The method is further configured as follows.

[0019] The present description also relates to a disinfection device, which comprises: a portion formed from a UV-transmissive material, the portion having a receptacle configured therein for receiving a target object to be sterilized, the receptacle having a first defined shape and a first defined dimension; an alignment portion having a second defined shape and a second defined dimension; Equipped with.

[0020] According to some particular embodiments, the disinfection device comprises one or more of the following features: The receptacle is configured to receive only a portion of the target item to be sterilized. The second prescribed shape is a cuboid. The UV-transmissive material includes at least one of a plastic, a glass, a gel, a polymer, polymethylmethacrylate (PMMA), and polystyrene. The tray portion is configured for single use. The disinfection device is a disposable device. The tray portion has at least fifty percent (50%) UV transparency. The tray portion has a UV transmittance of at least seventy-five percent (75%). The tray portion has at least ninety-five percent (95%) UV transparency. The tray sections are molded, blow molded, laser cut, or thermoformed structures. The sterilization device includes at least two handle mounting structures. The sterilization device includes at least two handles, each of which is configured to removably couple to a corresponding handle mounting structure. The alignment portion includes at least one alignment feature. At least one alignment feature is an electronic alignment feature. The electronic alignment feature comprises at least one time-of-flight sensor or at least one photodiode. The sterilization device includes a lid configured to cover at least the receptacle. The disinfection device comprises at least one UV sensor. The sterilization device comprises an electronics module, the electronics module comprising: Communication interface, User interface, and At least one clean / not clean indicator has. The electronics module is hermetically sealed within the device portion. The electronics module is configured to communicate identification information associated with the target object to be sterilized from the sterilization device to the sterilization system. The sterilization device comprises a mechanically sealable case configured to hold at least one device part, the mechanically sealable case configured to store at least one target object to be sterilized.

[0021] This description also discusses a method of disinfection, which includes: placing a target object to be sterilized within a receptacle device having at least one preformed receptacle configured for receiving the target object therein, the receptacle device being formed at least in part from a UV-transmissive material; placing a receptacle device within a sterilization chamber, the placing of the receptacle device including cooperatively aligning alignment features of the receptacle device with corresponding alignment features of the sterilization chamber; performing a UV-based disinfection process in the disinfection chamber; Includes.

[0022] According to some particular embodiments, the disinfection method includes one or more of the following features: The disinfection method is Determining a misalignment condition, the determining the misalignment condition comprising: Electronically determining whether a target object to be sterilized is properly aligned within at least one preformed receptacle; or Electronically determining whether the receptacle device is properly aligned within the sterilization chamber. determining whether the misalignment is due to Providing an output indication indicative of a misalignment condition; Includes. The disinfection method includes determining a misalignment condition, the determining the misalignment condition comprising: visually determining whether a target object to be sterilized is properly aligned within the at least one preformed receptacle; tactilely determining whether the receptacle device is properly aligned within the sterilization chamber; This is due to. The disinfection method is communicating identification information to the sterilization chamber, the identification information representing at least one of a receptacle device and a target object to be sterilized; Using identification information to select a UV-based disinfection process Includes. The disinfection method is generating metadata associated with the disinfection process; Communicating the metadata to a remote computing device; include. The metadata includes at least one of time information representing when the sterilization process was performed, date information representing when the sterilization process was performed, and user identification information. The metadata includes date information that indicates when the sanitization expires. The sterilization method includes extending the sterilization process based on accumulated radiation information obtained from the at least one radiation sensor. The sterilization method includes individually controlling a plurality of radiation sources in a sterilization chamber based on at least one of a receptacle device and a target object to be sterilized, where individually controlling the plurality of radiation sources includes directing a first radiation source to output radiation for a first time interval and directing a second radiation source to output radiation for a second time interval, the first time interval being different from the second time interval. Placing the target to be sterilized in a receptacle device having at least one preformed receptacle includes aligning the target to be sterilized on a surface of the receptacle device according to a template printed on the surface of the receptacle device. At least one pre-formed receptacle includes a plurality of clips configured to capture portions of a target object to be sterilized. The disinfection method includes verifying disinfection of the target object to be disinfected after performing at least a portion of the UV-based disinfection process. The determining includes sensing the UV radiation with at least one radiation sensor associated with the receptacle device. Alignment features of the receptacle device and corresponding alignment features of the sterilization chamber are at least partially formed by the electronic device. The electronic devices are configured to form optical, wireless, electromagnetic, or inductive connections. The sterilization method includes removing at least one handle structure from the receptacle device after placing the receptacle device in a sterilization chamber.

[0023] The present invention also features a disinfection system for reusable medical instruments, the disinfection system comprising: 1. A sterilization chamber comprising: An inner volume, at least one radiation source that outputs UV disinfection radiation when enabled, the at least one radiation source being suitable for emitting sufficient UV disinfection radiation to perform high-level disinfection; and A sterilization chamber controller configured to perform a high-level sterilization process by enabling at least one radiation source. a sterilization chamber having a A sterilization tray device adapted to be placed in a sterilization chamber, the sterilization tray device comprising at least one UV-transparent receptacle for receiving at least a portion of at least one instrument to be sterilized, the at least one UV-transparent receptacle being configured for a particular orientation and placement of the instrument to be sterilized; Equipped with.

[0024] According to some particular embodiments, the disinfection system comprises one or more of the following features: The sterilization tray device includes at least one first alignment feature that enables alignment of an instrument to be sterilized within the at least one UV-transparent receptacle. The at least one first alignment feature is a non-electronic physical structure, such as a template printed on a surface of the UV-transparent receptacle. At least one alignment feature is an electronic alignment feature. The sterilization chamber includes at least one sterilization chamber alignment feature, and the sterilization tray device includes at least one second sterilization tray alignment feature, the at least one second sterilization tray alignment feature configured to cooperate with the at least one sterilization chamber alignment feature when the sterilization tray device is placed within the sterilization chamber. The at least one second alignment feature and / or the at least one sterilization chamber are non-electronic physical structures. The sterilization tray device further comprises a sterilization controller configured to communicate identification information to the sterilization chamber controller, the identification information being indicative of at least one of the UV-transparent receptacle and the particular type of instrument to be sterilized. The sterilization chamber controller is further configured to select a sterilization process from the plurality of sterilization processes based on the identification information. The sterilization chamber controller is further configured to control the sterilization process based on the identification information. The sterilization device further comprises at least one electronic radiation sensor integrated into a surface of the sterilization device. The sterilization chamber controller is further configured to disable the at least one radiation source based on information from the at least one electronic radiation sensor. The disinfection tray device is a first electronic radiation sensor integrated into a surface of the sterilization tray device at a first location proximate the first receptacle portion of the UV-transparent receptacle; a second electronic radiation sensor integrated into a surface of the sterilization tray device at a second location proximate the second receptacle portion of the UV-transparent receptacle; and It further comprises: The sterilization chamber includes a plurality of radiation sources, and the sterilization chamber controller includes: selectively enabling and disabling a first radiation source among the plurality of radiation sources based on information from the first electronic radiation sensor; Selectively enabling and disabling a second radiation source among the plurality of radiation sources based on information from a second electronic radiation sensor. The method is further configured as follows. The sterilization system comprises an element suitable for verifying proper alignment of the sterilization tray device within the sterilization chamber and / or proper alignment of the instrument to be sterilized within the UV-transparent receptacle, the element being suitable for analyzing data from the sensor. The sterilization chamber controller is configured to enable the at least one radiation source to emit a radiation dose between 10 millijoules per square centimeter and 10 joules per square centimeter for a period between 10 seconds and 10 minutes. The sterilization chamber controller is configured to form multiple sterilization regions within the interior volume, and the sterilization chamber controller is configured to enable at least one radiation source to irradiate the sterilization regions with different radiation intensities, where at least one region is irradiated with twice or three times the radiation intensity of another region. The UV-transparent receptacles are configured such that when the sterilization tray device is positioned within the sterilization chamber, the instruments to be sterilized are oriented substantially horizontally within the sterilization chamber.

[0025] Non-limiting and non-exclusive embodiments are described with reference to the following drawings, in which like numerals refer to like parts throughout the various drawings unless otherwise specified. The sizes and relative positions of elements within the drawings are not necessarily to scale. For example, the shapes of the various elements are selected, enlarged, and positioned to improve the readability of the drawings. The particular shapes of the elements as illustrated are selected for ease of recognition in the figures. One or more embodiments are described below with reference to the accompanying drawings. [Brief description of the drawings]

[0026] [Figure 1A] FIG. 1 illustrates an embodiment of an exemplary sterilization chamber of a type that may be used in conjunction with the sterilization tray system described herein. [Figure 1B] FIG. 1 illustrates an embodiment of an exemplary sterilization chamber of a type that may be used in conjunction with the sterilization tray system described herein. [Figure 1C] FIG. 1 illustrates an embodiment of an exemplary sterilization chamber of a type that may be used in conjunction with the sterilization tray system described herein. [Figure 2A] FIG. 1 illustrates an example medical probe of a type that may be used in conjunction with the sterilization tray system described herein. [Figure 2B] FIG. 1 illustrates an example medical probe of a type that may be used in conjunction with the sterilization tray system described herein. [Figure 2C] FIG. 1 illustrates an example medical probe of a type that may be used in conjunction with the sterilization tray system described herein. [Figure 3A] 1A-1C illustrate an exemplary embodiment of a sterilization tray system configured to align and temporarily hold targets to be sterilized during the sterilization process. [Figure 3B] 1A-1C illustrate an exemplary embodiment of a sterilization tray system configured to align and temporarily hold targets to be sterilized during the sterilization process. [Figure 3C] 1A-1C illustrate an exemplary embodiment of a sterilization tray system configured to align and temporarily hold targets to be sterilized during the sterilization process. [Figure 3D] 1A-1C illustrate an exemplary embodiment of a sterilization tray system configured to align and temporarily hold targets to be sterilized during the sterilization process. [Figure 4A] FIG. 1 illustrates a further sanitization tray system embodiment. [Figure 4B]FIG. 1 illustrates a further sanitization tray system embodiment. [Figure 4C] FIG. 1 illustrates a further sanitization tray system embodiment. [Figure 4D] FIG. 1 illustrates a further sanitization tray system embodiment. [Figure 4E] FIG. 1 illustrates a further sanitization tray system embodiment. [Figure 5A] FIG. 13 illustrates an optional container portion that may be configured as part of the sanitization tray system. [Figure 5B] FIG. 13 illustrates an optional container portion that may be configured as part of the sanitization tray system. [Figure 6A] FIG. 1 illustrates an embodiment of a sterilization system configured to receive any one or more of the sterilization tray embodiments taught in the present disclosure. [Figure 6B] FIG. 1 illustrates an embodiment of a sterilization system configured to receive any one or more of the sterilization tray embodiments taught in the present disclosure. [Figure 6C] FIG. 1 illustrates an embodiment of a sterilization system configured to receive any one or more of the sterilization tray embodiments taught in the present disclosure. [Figure 6D] FIG. 1 illustrates an embodiment of a sterilization system configured to receive any one or more of the sterilization tray embodiments taught in the present disclosure. [Figure 6E] FIG. 1 illustrates an embodiment of a sterilization system configured to receive any one or more of the sterilization tray embodiments taught in the present disclosure. [Figure 7] FIG. 2 illustrates an example controller. [Figure 8] 1 is a data flow diagram illustrating a method of aligning a target object to be sterilized in a sterilization tray system, placing the sterilization tray system in the sterilization system, and sterilizing the target object. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] The present invention can be more readily understood by reference to this detailed description of the invention. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the claims unless such terminology is determined to be limiting by a competent court or licensing organization. Terms used herein are to be given their conventional meaning as known in the relevant art, unless expressly defined herein.

[0028] The device, method, and system embodiments described in this disclosure (i.e., the teachings of this disclosure) improve high-level disinfection (HLD) processes. This disclosure details specific disinfection tray systems, specific tray portions, specific integrated receptacles, and specific materials that allow certain ultraviolet (UV) radiation to pass (i.e., UV-transparent materials). This disclosure further describes specific electronics modules, performance of such modules, alignment features, handles, covers, cases, and other such features, and this disclosure describes specific disinfection chamber embodiments.

[0029] 1A-1C are exemplary sterilization chamber embodiments of a type that may be used in cooperation with the sterilization tray system described herein. In this specification, FIGS. 1A-1C may be collectively referred to as FIG. 1. The present disclosure includes a first sterilization system 100a embodiment in FIGS. 1A-1B, a second sterilization system 100b embodiment in FIG. 1C, and various other sterilization system 100c-100g embodiments in other figures. To simplify the disclosure, the sterilization systems 100a-100g may be referred to herein as sterilization system 100. When specific features of the sterilization system 100a-100g embodiments are discussed, the relevant figures and embodiments of interest are specifically identified.

[0030] In Figures 1A-1B, the sterilization system 100a is a high-level sterilization device comprising a sterilization chamber 102 and one or more radiation sources 104. The sterilization chamber 102 comprises a housing 106 having a number of side walls 108, a top 110, and a door 112 disposed in one of the side walls 108 for accessing an interior volume 114. The door 112 in Figure 1A comprises an interlock mechanism 112a that may be used to ensure that the door is in an open or closed position to ensure that the door is locked closed during a sterilization cycle or for other purposes. Although the door 112 in Figure 1A is illustrated as being rotatable about a vertical axis, other door configurations may be utilized as long as they provide sufficient access to the interior volume 114. It will be appreciated that when the door 112 is opened, an access opening 116 is formed in the sterilization chamber side wall 108, and the access opening 116 communicates with the interior volume 114. Of course, other sterilization chamber configurations are also contemplated.

[0031] The interior volume 114 of the sterilization chamber 102 may include one or more reflective surfaces 118 configured to aid in the reflection of radiation emitted from the radiation source 104 so that rapid and low-temperature sterilization is achieved. The reflective surfaces are typically formed from one or more materials having a reflectivity of at least 30%. "At least 30% reflectivity" means that less than 70% of the incident UV radiation, specifically within the UV-C band, is absorbed and the remainder of the incident radiation is reflected by one or both of diffuse and specular reflection. Reflective materials that may be particularly useful in sterilization chambers include, but are not limited to, aluminum, glass, magnesium, stainless steel, polyvinyl alcohol, polytetrafluoroethylene, substrates treated with barium sulfate-containing paint, and alloys, derivatives, and copolymers thereof. In some variations, the reflective surface includes aluminum polished to a "Grand Brilliant" condition. In other variations, the reflective surface may be formed using polytetrafluoroethylene PTFE, or PTFE and similar polymers may be coated by various means onto another substrate to form the reflective surface. In certain embodiments, the reflective interior surfaces of the sterilization chamber are formed to have a reflective nature as permitted by available manufacturing techniques. Such an approach facilitates sterilization processes utilizing high intensity sterilizing radiation carried out at low temperatures.

[0032] The internal reflective surfaces 118 of the interior volume 114 may be positioned and shaped to reduce UV radiation absorption by the interior surfaces 118 and instead reflect and redirect the UV radiation within the interior volume 114 of the sterilization chamber 102 to one or more targets 120 positioned within the interior volume 114. The material selection and configuration of the interior volume 114 of the sterilization chamber 102 may be selected to promote preferential extinction of electromagnetic energy of specific UV wavelengths or other wavelengths (i.e., longer radiation wavelengths) that may contribute to temperature rise within the interior volume 114. That is, the shape of the interior volume 114 may contribute to rapid and efficient redirection of radiation to the targets 120. For example, radiation passing through a middle portion of the interior volume 114 of the sterilization chamber 102, where the targets 120 are to be positioned, and the reflective materials used in the interior volume 114 may be configured to contribute to radiation reflection (e.g., re-radiation or re-emission) with low loss (i.e., nearly the same amount of energy is returned from the surface as was incident). In certain embodiments, the interior walls of the interior volume 114 are structured and configured to reduce loss of UV-C radiation emitted from one or more UV radiation sources 104 (not specifically shown in FIG. 1A for simplicity). Such embodiments increase the likelihood that UV-C radiation useful for disinfection will be reflected one or more times within the interior volume 114 of the disinfection chamber 102 until it strikes the target 120 to be disinfected where it can be absorbed and extinguished, reflected, or re-emitted. In this way, the usefulness of UV-C band energy useful in disinfecting the target 120 (e.g., a medical device, dental instrument, electronic component, or any other target to be disinfected) can be improved while reducing the amount of thermal heating of the target 120 (e.g., a medical device, dental instrument, electronic component, or any other target to be disinfected) for a given amount of total energy emitted into the disinfection chamber 102, which may further include some amount of infrared or thermal energy.

[0033] In certain embodiments, a suspension assembly 122 may be provided that positions the target 120 in a central portion or other desired portion of the sterilization chamber 102 where a high intensity radiation sterilization field is to be formed. In some variations, the suspension assembly 122 includes a slot in the top of the assembly that extends to a central portion of the top 110 of the sterilization chamber 102, for example, when the target 120 is coupled to a cable that may extend into the interior volume 114 of the sterilization chamber 102. In some examples, the suspension assembly 122 may include one or more control mechanisms configured to receive control signals from a processing device, such as the electronic control module 160 (FIG. 7). In these or other examples, the suspension assembly 122 may operate to adjust the position of the target 120 within the sterilization chamber 102 in two dimensions (e.g., up and down, left and right), three dimensions (e.g., rotation, lateral movement), four dimensions (e.g., time dependent, movement during a sterilization cycle), or some other dimension according to a generated sterilization program. In some examples, the suspension assembly 122 includes alignment features 124 that aid in aligning the target object 120. In some examples, the suspension assembly 122 is permanently or semi-permanently fixed so that the target object 120, once placed within the interior volume 114 of the sterilization chamber 102, does not move during a sterilization cycle.

[0034] In various embodiments, any number of alignment features 124 are positioned in suitable locations within the sterilization chamber 102. In FIG. 1B, for example, twelve alignment features 124 are shown. In other embodiments, a different number of alignment features 124 may be provided. The alignment features are sized, shaped, positioned, or otherwise configured to cooperate with corresponding alignment features of a sterilization tray system 130 (FIG. 3) positioned within the interior volume 114 of the sterilization chamber 102. In the embodiment of FIG. 1B, some of the alignment features 124 are positioned normal to one another and some of the alignment features 124 are positioned opposite one another. Additionally, the alignment features 124 of FIG. 1B are formed on each of the four interior sidewalls 108 of the sterilization chamber 102. In still other embodiments, more or fewer alignment features 124 are disposed and may be formed on the top of the sterilization chamber 102, the bottom of the sterilization chamber 102, or some other portion of the sterilization chamber 102. In some examples, zero or only one alignment feature 124 is disposed within the sterilization chamber 102. In some examples, one or more alignment features 124 are movable structures that may be disposed in a first position during a first sterilization cycle and disposed in a second, different position during a second sterilization cycle.

[0035] As detailed herein, the disinfecting radiation utilized can be UV-C radiation, and in embodiments using UV-C radiation, the one or more radiation sources 104 may be any commercially available device suitable for emitting sufficient UV-C radiation to perform high-level disinfection. When one source 104 of UV-C radiation is coupled to the disinfection chamber 102, the source 104 emits sufficient UV-C radiation to perform high-level disinfection. When two or more UV-C radiation sources are coupled to the disinfection chamber 102, each UV-C radiation source 104 may be capable of emitting sufficient UV-C radiation to perform high-level disinfection. Alternatively, in embodiments of the system 100 that include two or more UV-C sources coupled to the interior volume 114 of the sterilization chamber 102, each such radiation source 104 may emit UV-C radiation that is insufficient by itself to achieve high-level disinfection, but when the individual outputs of UV-C radiation emitted from the two or more sources 104 are combined, the total output of UV-C radiation is sufficient to achieve high-level disinfection.

[0036] The radiation source 104 may be coupled to the interior volume 114 by a variety of approaches. For example, the radiation source 104 may be locally mounted to the interior volume 114 to emit UV-C radiation within the interior volume 114, as shown in FIG. 1B for illustrative purposes. In a further example, the radiation source 104 may be remotely coupled to the interior volume 114. For example, the radiation source 104 may be a standard laser or a solid-state laser photodiode and may be used as a sterilization energy source for the stand-alone sterilization chamber 102 with appropriate optical conductors and couplers to emit UV-C radiation within the interior volume 114. Additionally, in some embodiments, a direct or conductive UV radiation source may be steered via mirrors or other devices or scanned along a target 120 positioned within the interior volume 114. In other embodiments, the sterilization chamber 102 may include a movable mounting assembly within the interior volume 114, not specifically shown to avoid unnecessarily cluttering the drawing, such that the target 120 may be positioned on the movable base and moved past the fixed radiation-emitting area. An electronic control module (e.g., controller 160 in FIG. 7) may control the radiation source 104 and the movable base to rotate or move in opposite directions to provide preferential exposure of the target 120 to UV radiation.

[0037] Although the devices, methods, and systems presented herein are primarily described with reference to UV-C radiation as the disinfection radiation in the disinfection chamber, this is for illustrative purposes only. The radiation or energy used in the disinfection system 100 may be or may include UV-A radiation, UV-B radiation, or even non-UV radiation, alone or in various combinations. Furthermore, it is understood that within the interior volume 114, exposure of objects to UV radiation may be performed in various ways.

[0038] Instead of UV radiation, such as UV-C radiation, some variations of the device taught herein may use a flash energy source. The flash energy source emits extremely high intensity disinfecting radiation. The flash energy source may achieve high-level disinfection of one or more contaminants in an acceptably short time. In certain embodiments, the flash energy source may deliver disinfecting radiation to one or more objects at a high rate such that high-level disinfection is achieved in a time selected from among 10 seconds or less, 5 seconds or less, 3 seconds or less, and 2 seconds or less. The flash energy source as contemplated herein may be selected to deliver any selected disinfecting radiation. For example, the disinfection system as described herein may include a flash energy source that emits electron beam, gamma radiation, X-ray, gas plasma, or UV-C radiation. The biological activity mechanism of disinfection of the flash source may differ for each individual flash source. For example, gamma radiation may completely kill pathogens, while UV-C may leave pathogens alive but biologically infertile and unable to replicate.

[0039] In the case where a flash energy source is used, one radiation source 104 of disinfecting radiation may be all that is needed within the interior volume 114 of the disinfection chamber 102. In such an embodiment, to achieve a substantially homogenous or uniform radiation exposure to the target 120, the radiation emitted by the flash source may first strike a surface that diffuses and distributes the radiation before striking the target. In this example, the target will receive primarily indirect irradiation rather than direct irradiation. In other words, the disinfection device may be configured such that any suitable type of radiation source 104 is placed in a different part of the disinfection chamber 102 than the target 120. Because the energy spectrum emitted by some types of flash sources may be broad, in some examples, a filter (not shown) may be placed between the radiation source 104 and the target 120 so that only the spectrum of interest may be sent to the interior volume 114. The filter may serve to reduce the presence of infrared energy in the chamber, which does not sterilize the sterilization chamber 102, but which heats the sterilization chamber 102 and thus increases the temperature of the sterilization chamber 102 and objects contained therein. The filter may also be useful when implemented with other radiation sources described herein. A combination of sterilization energy sources may be used in the devices and systems described herein. When two or more different sterilization energy sources are used, the sterilization energy sources may be applied sequentially, in parallel, or in various combinations and sequences. Having and using two or more different sterilization energy sources may be advantageous in situations where certain pathogens are more susceptible to a particular sterilization energy source, and it may be useful to use different radiation sources, durations, and doses to achieve acceptable sterilization for the pathogens of interest in order to reduce the overall exposure of the target objects 120.

[0040] Where the devices and systems described herein utilize UV ​​radiation, such as UV-C radiation, one or more UV radiation sources 104 and / or one or more UV radiation sensors 126 are positioned within the interior volume 114 of the sterilization chamber 102 in a manner conducive to rapid low-temperature disinfection. In general, the configuration of the sterilization chamber 102, sterilization radiation sources, and sensors that detect the sterilization radiation will be selected to achieve and confirm selective exposure of one or more objects to radiation and / or to efficiently and reproducibly target objects by optimizing radiation propagation from the one or more sources.

[0041] As mentioned, a disinfection chamber 102 according to the present disclosure may be coupled to a single source 104 of disinfecting radiation, such as one UV-C radiation source. In such an embodiment, the radiation source may be positioned on the top or bottom of the chamber. Alternatively, depending on the positioning of the target object 120 to be disinfected, the single radiation source 104 may be positioned on a side of the disinfection chamber, or at an intersection formed at the intersection of two sides if the disinfection chamber comprises multiple sides. However, the devices and systems described herein are not limited to disinfection chambers having a single disinfecting radiation source.

[0042] The disinfection chamber 102 included in the systems, devices, and methods of the present disclosure may use multiple radiation sources 104, either the same or different, and various embodiments of the disinfection chamber 102 having multiple disinfecting radiation sources 104 are detailed herein and illustrated in the accompanying drawings. Such embodiments may be advantageous when each surface of one or more targets 120 to be disinfected is more complex than a single flat surface. For example, a target 120 to be disinfected, such as an endotracheal or ultrasound probe, may have two or more of anterior, posterior, lateral, and ventral and / or dorsal surfaces that require disinfection. In such a scenario, it may be difficult to deliver high intensity radiation to each surface of the target 120 using a single source or type of disinfecting radiation. Thus, in some embodiments of the disinfection device / system 100 described herein, the radiation source 104 and other structures are arranged to disinfect one particular type of target. That is, while the radiation source 104 and / or other structures irradiate each surface of a particular target 120, the device does not function effectively when different types of targets 120 are placed within the sterilization chamber 102.

[0043] Radiation sources 104 that may be used in the devices and systems as described herein are available in the art and include, for example, UV-C emitting lamps. UV-C emitting lamps, sometimes referred to herein as "tubes," are commercially available from a variety of sources, including Philips Lighting BV, and are available in a variety of shapes, sizes, input energies, and UV-C output ratings. UV-C tubes suitable for use as UV-C energy sources include low-pressure mercury discharge lamps. However, the disinfection chamber is not limited to a particular UV-C source. Any source capable of emitting UV-C light within a selected UV-C wavelength at an output rating that contributes to disinfecting the target object 120 may be used in the devices disclosed herein. For example, in addition to or as an alternative to one or more UV-C tubes, one or more lasers or photodiodes, or a source array, or a combination of source types designed to emit UV-C light, may be used to deliver disinfecting radiation in the disinfection chamber.

[0044] In certain embodiments, one or more UV-C radiation sources included in the disinfection chamber 102 described herein provide a total UV-C power output selected to be at least 5 watts of radiation intensity into the interior volume 114 of the disinfection chamber 102. Selection of such radiation sources capable of delivering high-power radiation doses may be preferred for shortening disinfection cycles. That is, by selecting a high-power radiation source, energy may be delivered quickly, thereby shortening radiation exposure duration or reducing the amount of heat generated by radiation. In other examples, one or more radiation sources 104 may be selected to provide a total UV-C power output selected from radiation intensities of at least 10W, at least 15W, at least 20W, at least 25W, at least 30W, at least 40W, at least 50W, at least 75W, at least 90W, and at least 100W into the interior volume 114 of the chamber. When a UV-C source is used as the disinfection radiation source(s) 104, the frequency band of UV-C light emitted from these sources(s) may be selected from between about 240 nm and about 270 nm and between about 255 nm and about 265 nm. In other examples, the radiation source 104 may output some other form of radiation, such as UV-A radiation (e.g., 320-400 nm), UV-B radiation (e.g., 280-320 nm), or UV-C radiation (e.g., 100-280 nm).

[0045] Figure 1C is an embodiment of another sterilization system 100b similar to the sterilization system 100a of Figures 1A-1B. Some features of the sterilization system 100b common to other sterilization systems 100 in the present disclosure are not identified to avoid unnecessarily cluttering the drawing.

[0046] As seen in the embodiment of Figure 1C, the various sterilization systems 100 may be configured having any suitable size, shape, and dimensions. The various sterilization systems 100 may include any number of doors, door positions, door shapes, door sizes, etc. The various sterilization systems 100 may include any number of radiation sources 104, radiation source configurations, and control mechanisms for such radiation sources.

[0047] In the sterilization system 100b, multiple radiation sources 104, 104a, 104b, 104c are positioned at various locations in the sterilization chamber. In the exemplary embodiment of FIG. 1C, three radiation sources 104 are located at "corners" located on three opposite sides of the sterilization chamber, and three different radiation sources 104a, 104b, 104c are located at corners located on a fourth opposite side of the sterilization chamber. In the embodiment of FIG. 1C, when all of the radiation sources 104, 104a, 104b, 104c are operating simultaneously, the portion of the sterilization chamber located near the three radiation sources 104a, 104b, 104c can be expected to receive a higher radiation dose than the other portions of the sterilization chamber. By placing more or fewer radiation sources in the first portion of the sterilization chamber, the radiation dose in the first portion of the sterilization chamber can be higher or lower than the radiation dose in the other portions of the chamber. Additionally, by selectively operating various of the radiation sources 104, 104a, 104b, 104c, the radiation dose in one portion of the sterilization chamber may be increased or decreased as desired relative to other portions of the sterilization chamber.

[0048] The radiation sources 104, 104a, 104b, 104c may have any suitable dimensions, configurations, and operating parameters. Any or all of the radiation sources 104, 104a, 104b, 104c may be similar to or different from the other of the radiation sources 104, 104a, 104b, 104c. For example, in the illustrated embodiment of FIG. 1C, each radiation source 104a, 104b, 104c has a size and configuration similar to the radiation source 104. In other examples, the radiation sources 104a, 104b, 104c may be combined into a single larger radiation source (not shown). In this specification, any one or more of the radiation sources 104, 104a, 104b, 104c may be referred to as the radiation source 104 to simplify the discussion in this disclosure.

[0049] In the embodiment of the sterilization system 100b of FIG. 1C, multiple radiation sensors 126 are positioned at various locations within the sterilization chamber. These locations may be arranged such that one or more of the radiation sensors 126 receive radiation from one or more radiation sources 104. The radiation sources 104, 104a, 104b, 104c may be arranged symmetrically, asymmetrically, or in any other pattern. The radiation sources may be irradiated simultaneously, randomly, sequentially, or according to some other irradiation scheme.

[0050] The controller 160a is arranged to direct the operation of the sterilization system 100. In some examples, the controller 160a may control the operating and communication parameters of the radiation sensors 126. In these and other examples, the controller 160a also directs the operation of the radiation sensors 126 and receives radiation sensor data from the radiation sensors 126. The radiation sensor data may include, for example, numerical information representing or otherwise indicating the amount of radiation reaching each radiation sensor 126. The controller 160a also directs the operation of the radiation sources 104. The controller 160a may command or otherwise direct one or more of the radiation sources 104 to output radiation based on the radiation sensor data from one or more of the radiation sensors 126. In at least some examples, the controller 160a directs the operation of the radiation sources 104 and the radiation sensors 126 based on a software program constituted by a set of computer-executable instructions executed by the controller 160a.

[0051] FIG. 2A is a known broadband linear array ultrasound transducer probe 128a for general abdominal imaging procedures. FIG. 2B is a known intracavity ultrasound transducer probe 128b for invasive medical imaging. FIG. 2C is a known handheld convex array ultrasound transducer probe 128c for prenatal testing, cardiac health screening, and other medical procedures. For the sake of brevity, medical probes 128a-128c that are to be sterilized according to the teachings herein may be referred to as probes 128 herein. Probes 128 and other instruments that are to be sterilized according to the teachings herein may be referred to as targets 120 herein. FIGS. 2A-2C may be collectively referred to as FIG. 2 herein.

[0052] Medical devices such as the probe 128 of FIG. 2 are manufactured in many different forms. These devices can be small diameter invasive instruments such as catheters, intracavity probes, and dental instruments. Other devices can be non-invasive, such as palm-sized and handheld medical probes. Still other devices can be used in non-medical environments such as electronics, space-bound devices, micro-instruments, and pharmaceutical and other consumable manufacturing spaces. The manufactured structures of such devices can be simple or complex. The probes of FIG. 2 are illustrated because they illustrate complex angles, symmetrical and asymmetrical parts, various materials, irregular sizes, and irregular shapes. Heretofore, efficient disinfection of such devices with radiation such as UV has been difficult and in some instances previously impossible.

[0053] 3A-3D are exemplary embodiments of a sterilization tray system configured to align and temporarily hold targets to be sterilized during a sterilization process. The exemplary sterilization tray system embodiments of FIGs. 3A-3D may be used in conjunction with one or more of the sterilization chamber 102 embodiments described herein. FIGs. 3A-3D may be collectively referred to herein as FIG. 3.

[0054] 3A is one embodiment of a sanitizing tray system 130a. The sanitizing tray system 130a includes a tray portion 134a formed from a UV-transmissive material and an alignment portion 136. The tray portion 134a generally includes a surface of the sanitizing tray system 130a, some features formed on the surface of the sanitizing tray system 130a, and some features that extend into the surface of the sanitizing tray system 130a. For example, the tray portion 134a includes a receptacle 132a that is formed on the surface of the sanitizing tray system 130a and that, in this embodiment, extends downward into the surface of the sanitizing tray system 130a.

[0055] The alignment portion 136 of the sanitization tray system 130a comprises the shape and one or more dimensions of the sanitization tray system 130a and zero or more optional features used to align the sanitization tray system 130a within the interior volume of the sanitization chamber 102. In the embodiment of FIG. 3A, the alignment portion 136 comprises a cuboid shape having a length L, a width W, and a height H. Other shapes, including complex shapes, are of course contemplated.

[0056] In the embodiment of the cuboid-shaped sterilization tray system 130a of FIG. 3A, the tray portion 134a has the same length and width as the alignment portion 136. Additionally, the tray portion 134a of FIG. 3A extends into the surface of the sterilization tray system 130a, and in at least some examples, the tray portion 134a may have the same height as the alignment portion. Thus, in some embodiments, the shape and dimensions of the tray portion 134a may define the shape and dimensions of the alignment portion 136. In this manner, the shape and dimensions of the tray portion 134a, which define the shape and dimensions of the alignment portion 136, cooperate with features within the interior volume 114 of the sterilization chamber 102 to properly align the target to be sterilized (e.g., the target 120 of FIG. 1 or the probe 128 of FIG. 2 ) with respect to the radiation source 104 of the sterilization chamber 102.

[0057] Optionally, the alignment portion 136 may further comprise an inner frame (not shown), an outer frame (not shown), stiffening members (not shown), and any other such features to assist in proper placement of the sterilization tray system 130a within the sterilization chamber. In some examples, these structural supports may further provide support for the UV-transmissive material of the tray portion 134a.

[0058] In some examples, the alignment portion 136 may comprise a particular structure dedicated to alignment of the sterilization tray system 130a in the sterilization chamber. For example, three alignment features 124 are shown in the embodiment of FIG. 3A, some of which are not identified to avoid cluttering the drawing. These alignment features 124 in the sterilization tray system 130a cooperate with corresponding alignment features 124 in the sterilization system 100a of FIG. 1A. The shapes, sizes, positions, and other such parameters of the alignment features 124 in FIG. 1A and FIG. 3A are non-limiting, and alignment features having any other suitable shapes, sizes, positions, etc. are further contemplated. In various embodiments, the alignment features 124 may be ridges and corresponding depressions, protrusions and corresponding openings, or any other suitable mating structures.

[0059] In some examples, the alignment feature 124 comprises one or more radiation sensors 126 and one or more corresponding light sources 104. For example, in at least one embodiment, a first light source 104 in the sterilization chamber 102 is directed toward a first radiation sensor 126a, which is located at a recessed location in the surface of the sterilization tray system 130a. In this manner, a portion of the tray portion 134a forms a cylindrical wall around the surface of the first radiation sensor 126a, which substantially prevents indirect radiation from reaching the radiation sensor 126a. In contrast, if the surface of the radiation sensor 126a is located within the line of sight of the selected first light source 104, the radiation will reach the radiation sensor 126a, and the light source 104 and radiation sensor 126a may be paired as an alignment feature to indicate that the sterilization tray system 130a is properly aligned in the sterilization chamber 102. In other examples, a separate cylindrical body may be disposed around the radiation sensor 126a forming a wall to filter indirect radiation, whether such wall is a separate cylindrical body, a part of the tray portion 134a, or some other wall, which may be disposed at any suitable angle and other orientation to align as desired with the selected light source 104.

[0060] In some examples, the alignment features 124 comprise a wireless transmitter and a corresponding receiver. In at least some of these examples, a small directed energy radio frequency (RF) transmitter may be paired with a corresponding receiver. The respective antennas of the transmitter and receiver may be aligned (e.g., via a waveguide) to identify when the sterilization tray system 130a is properly aligned within the sterilization chamber 102. Alternatively or additionally, the RF signal may be encoded such that data from a time-of-flight sensor in the receiver may be used to identify when the sterilization tray system 130a is properly aligned within the sterilization chamber 102. In still other examples, the corresponding alignment features 124 of the sterilization tray system 130a and the sterilization chamber 102 may comprise any one or more of electromagnetic alignment features, dielectric alignment features, and other types of electronic and non-electronic alignment features.

[0061] The tray portion 134a in the embodiment of FIG. 3A has a primary receptacle portion 138a arranged to receive a first portion of a target object to be sterilized, an alignment receptacle portion 138b, and a secondary receptacle portion 138c arranged to receive a second portion of a target object to be sterilized. Each receptacle portion 138a-138c has a defined shape and any number of defined dimensions. In some examples, each receptacle portion 138a-138c has the same shape and dimensions, while in other examples, one or more of the receptacle portions 138a-138c have different shapes, different dimensions, or different shapes and different dimensions. Although the tray portion 134a in FIG. 3A has a single primary receptacle portion 138a, a single alignment receptacle portion 138b, and a single secondary receptacle portion 138c, in other examples, the tray portion may have any number of receptacle portions. For example, a separate tray portion may have only a first receptacle portion, a first receptacle portion, a second receptacle portion, and a third receptacle portion, a first alignment receptacle portion and a second alignment receptacle portion, or any other number of primary receptacle portions, secondary receptacle portions, and alignment receptacle portions.

[0062] 3A has a single continuous uniform alignment receptacle portion 138b, in other examples a tray portion may have an alignment receptacle portion with any number of sub-portions. For example, in some examples, the alignment receptacle portion 138b comprises two or more continuous uniform alignment receptacle portions 138b separated by a different receptacle portion. Such an implementation may be useful, for example, for a probe having a connector at a first proximal end position of the cable, a control mechanism at an interim second position of the cable, and a sensor or other patient contact point at a third distal end of the cable.

[0063] In some embodiments, the alignment receptacle portion may terminate at the raw border of the tray portion 134a, such that, for example, the receptacle is configured to receive a portion of a target object to be sterilized, such that a flexible portion of the target object to be sterilized (e.g., a cable or hose, etc.) is disposed within the alignment receptacle portion, and a portion of the target object that is not to be sterilized extends beyond the border of the tray portion.

[0064] An embodiment of the disinfection tray system 130a is configured to closely accommodate a target to be disinfected. For example, the target may be the target 120 (FIG. 1), a medical probe similar to the probe 128 of FIG. 2, or some other target to be disinfected. In this embodiment, a first sensor portion of the target to be disinfected is placed in the first receptacle 136a, and a "cable" portion of the target is placed in the alignment portion 136b. A third connector portion of the target is placed in the second receptacle 136c, and then the disinfection tray system 130a is placed in a chamber similar to the disinfection chamber 102 of FIG. 1. The UV transparency of the tray portion 134 allows each portion of the target intended to be disinfected during the disinfection procedure to be disinfected.

[0065] The sterilization tray system 130a may optionally include one or more structures formed from a radiation sensitive medium 140. The radiation sensitive medium may include, for example, a dye, liquid, paint, film, glass, ceramic, or any other medium that reacts when exposed to a particular form of radiation, such as ultraviolet radiation. In at least some embodiments, the radiation sensitive medium 140 is a photochromic material (such as photosensitive paper and color-changing ultraviolet detector beads) that changes color when exposed to radiation from the radiation source 104, and the color change may represent the amount of radiation to which the target object has been exposed. In these and other examples, exposure to radiation from the radiation source 104 induces a measurable change in the electrical conductivity of the radiation sensitive medium 140, and in these examples, the change in electrical conductivity may be utilized to determine the amount of radiation delivered to the target object. In at least some examples, the radiation sensitive material may include silver halide. In other examples, the radiation sensitive material may include silica, alumina, and metal fluorides, such as cadmium fluoride, lead fluoride, or some other fluoride. Other radiation sensitive elements and compounds are also contemplated.

[0066] An optional controller 160b is disposed in the sterilization tray system 130a of FIG. 3A. A controller 160b similar to the controller 160a in the sterilization system 100 of FIG. 1 may be disposed in any of the sterilization tray systems of the present disclosure. As described herein, the controller 160b may be configured to include one or more of a processor, a memory, at least one transceiver, a user interface, and any number of peripheral devices (e.g., clocks, control circuitry, power circuitry, etc.). The controller 160b may be configured to maintain a time value indicating when the sterilization tray system 130a was last exposed to sterilization radiation (e.g., time information identifying the execution of one or more previous sterilization cycles). The controller 160b may be configured to indicate that a target object is properly positioned in the receptacle 132a. The controller 160b may also control the transmission and reception of information such as a serial number, identification information, the type of target object that may be sterilized in the sterilization tray 130a, the alignment of the sterilization tray 130a in the sterilization chamber 102, and any other such information.

[0067] FIG. 3B is another embodiment of a sterilization tray system 130b. The sterilization tray system 130b includes a tray portion 134b formed from a UV-transmissive material and a receptacle 132b. A target object 120 is aligned in the receptacle 132b. Other structures and features of the sterilization tray system 130b are not identified to avoid cluttering the drawing. As is apparent in FIG. 3B, the receptacle 132b is configured for a specific target object 120, and more specifically, for a specific orientation and placement of the target object 120 in the receptacle 132b. This target object 120 could not have been intuitively or instructively placed in the receptacle 132b in any other suitable manner. When so configured, and when the sterilization tray system 130b is positioned within the sterilization chamber 102, radiation from the radiation source 104 (FIG. 1) penetrates the sterilization tray 134b and exposes all surfaces of the target object 120 to sterilizing radiation. In at least some examples, the controller 160b is configured to receive and analyze sensor data from the one or more radiation sensors 126, and based on this analysis, the controller 160b is configured to control, direct, or otherwise govern the operation of the radiation source 104 within the sterilization chamber 102.

[0068] 3C is yet another embodiment of a sanitizing tray system 130c. The sanitizing tray system 130c includes a tray portion 134c and a receptacle 132c formed from a UV-transmissive material. The sanitizing tray system 130c embodiment of FIG. 3C also includes an alignment receptacle piercing portion 142 formed in the raw border of the tray portion 134c.

[0069] When a target to be sterilized is placed in the sterilization tray system 130c, a first portion of the target may be placed in the primary receptacle portion 138a. For example, the first portion of the target may be an ultrasonic sensor probe that contacts the patient's body. A second portion of the target, which may be a cable, may be placed in the alignment receptacle portion 138b, which snakes through the surface of the tray portion 134c. A handheld controller portion of the target to be sterilized may be placed in the secondary receptacle portion 138c, with the cable originating at the handheld controller portion of the target continuing beyond the boundary threshold of the tray portion 134c at the alignment receptacle penetration portion 142. The cable of the target that extends from the sterilization tray system 130c is generally the portion of the target that plugs into that particular device (e.g., an ultrasonic machine). This cable section may be disposed within the sterilization chamber 102 , although sterilization of this cable section may not be the primary function of the sterilization system 100 .

[0070] FIG. 3D is an embodiment of a sterilization tray system 130d having receptacles 138 with a very small depth (e.g., about 50 millimeters (mm), about 30 mm, about 10 mm, or less), or in some instances no depth at all. The tray portion 134d of the sterilization tray system 130d is formed from a UV-transparent material. An optional template pattern of targets to be sterilized may be integrated into or otherwise presented on a surface of the tray portion 134d. One or more retaining structures 144a-144f are configured to temporarily align and secure the targets to be sterilized to the tray portion 134d.

[0071] In at least some examples, the template pattern of the receptacle 138 may be formed from a radiation sensitive material. In this manner, the template may be used both to guide a user in proper positioning of targets to be sterilized and as an indicator that a sterilization cycle is being performed. In other examples, the template pattern may be printed on, adhered to, or otherwise integrated into the tray portion 134d. The template pattern may include printed text instructions for the user to guide proper alignment and positioning of targets to be sterilized.

[0072] The sterilization tray system 130d may include any suitable number of retaining structures 144a-144f. The retaining structures may be formed as clips, clamps, clasps, brackets, or some other type of fastening means. The retaining structures 144a-144f may be formed in whole or in part from a UV-transparent material. In some examples, one or more of the retaining structures 144a-144f may be moved, removed, repositioned, reoriented, or otherwise placed in a position and orientation desired by a user.

[0073] In some examples, two or more template patterns may be formed on the same tray portion 134d. In at least some of these examples, the tray portion 134d may have a retaining structure 144a-144f for each of the two or more templates. In others of these examples, one or more retaining structures 144a-144f may be positioned by a user in a particular location and orientation appropriate for each target object corresponding to a particular template. Thus, some embodiments of the sterilization tray system 130d may include fixed retaining structures, and these or other embodiments may include removable or otherwise repositionable retaining structures.

[0074] 4A-4E are sanitization tray system embodiments 130e-130i that illustrate the flexibility of the present sanitization technology. The sanitization tray system embodiments 130e-130i may be formed completely or partially from a UV-transmissive material. The sanitization tray system embodiments 130e-130i include one or more receptacles 132e-132i formed in corresponding tray portions 134e-134i, respectively. The receptacles 132e-132i are similar to other receptacles described in more detail in this disclosure. The receptacles 132e-132i are simplified to more clearly show other features of the sanitization tray system embodiments 130e-130i.

[0075] Each of the sanitization tray system embodiments 130e-130i has a different alignment portion 136. The alignment portion 136 comprises a shape and one or more dimensions of the respective sanitization tray system 130e-130i. The alignment portion 136 of the sanitization tray system embodiments 130e-130h of Figures 4A-4D comprises a cuboid shape, a length L, a width W, and a height H. The alignment portion 136 of the sanitization tray system embodiment 130i of Figure 4E comprises a disk shape, a diameter D, and a height H. Other simple and complex shapes are also contemplated.

[0076] The sanitization tray system embodiment 130e of FIG. 4A may have a height of two or three centimeters (2 cm or 3 cm) or less. The sanitization tray system embodiment 130f of FIG. 4B may have a height of three centimeters (3 cm) or more. The sanitization tray system embodiments 130e, 130f have the same length L and the same width W. The length and width of the various sanitization tray system embodiments taught in the present disclosure may be selected as desired for use in a selected sanitization system 100.

[0077] In FIG. 4C, the sanitization tray system embodiment 130g includes a plurality of receptacles 132g configured to accommodate a particular target object to be sanitized. Each receptacle 132g formed in the surface of the tray portion 134g may be similar to all of the other receptacles 132g in some examples. In other examples, only some of the receptacles 132g are similar to the other receptacles 132g. In still other examples, none of the plurality of receptacles 132g are similar to any other receptacle 132g. By using the sanitization tray system embodiment 130g of FIG. 4C, two or more targets may be sanitized simultaneously.

[0078] The sanitization tray system embodiment 130h of Figure 4D is relatively smaller than other sanitization tray system embodiments of the present disclosure. In at least some examples, multiple sanitization tray system embodiments 130h may be placed simultaneously within a particular sanitization chamber 102, such that two or more target objects may be sanitized simultaneously.

[0079] In Fig. 4E, a disk-shaped disinfection tray system embodiment 130i is presented. This disk-shaped disinfection tray system embodiment 130i may be configured to more easily align a certain target to be disinfected. Additionally or alternatively, the disk-shaped embodiment may allow for easier alignment within a certain disinfection system 100. The disk-shaped disinfection tray system embodiment 130i and any other disinfection tray system embodiment having a particular shape may be selected for other reasons.

[0080] 5A and 5B show an optional container portion 146 that may be configured as part of the sterilization tray systems 130a-130i. Figures 5A-5B may be collectively referred to herein as Figure 5.

[0081] FIG. 5A is a sterilization tray system 130j that includes a container portion 146 configured to hold at least one tray portion 134j. In the embodiment of FIG. 5A, the container portion 146 is a mechanically sealable case 146. The mechanically sealable case may be configured to store any number of targets before, during, and after sterilization. In some examples, the container portion 146 is configured to store one or more targets for an extended period of time after the sterilization process. In this manner, for example, targets may be sterilized at a first time and then stored until a second time closer to when the targets are to be used. Any number of minutes, hours, days, months, or years may elapse between the first and second times.

[0082] In some examples, the container portion 146 may be partially or completely formed from a UV-transmissive material. The container portion 146 may be a solid structure that completely houses the tray portion 134j. Alternatively, the container portion 146 may be a mesh or net, a frame, or some other construction. In some examples, the container portion 146 has a shape and one or more dimensions that define a registration portion of the sterilization tray system 130j similar to the registration portion 136 of Figures 3 and 4.

[0083] Optionally, the mechanically sealable case of FIG. 5A may include one or more handles 148a, 148b, a locking mechanism 150, a lid portion 152, and other optional features. The optional handles 148a, 148b may be located on both sides of the container portion 146 as illustrated in FIG. 5A. In other embodiments, one of ordinary skill in the art will appreciate that one or more handles may be located on all sides of the container portion 146, on the top of the container portion 146, on the bottom of the container portion 146, or in any other location. Each handle 148a, 148b may have two points of contact with the container portion 146 as illustrated in FIG. 5A. Alternatively, the handles 148a, 148b may take other suitable shapes. These handles may be loops, buttons, prongs, knobs, shafts, grips, or some other structure. The handles may be rigid or flexible. The handles may be temporary or permanent. In some examples, the handles may have features (e.g., pegs, pins, hooks, openings, protrusions, or any other suitable structures) that cooperate with corresponding features of the container portion 146 to facilitate placement and use of the handles, such as when the handles 148a, 148b are first installed and used for transporting the sterilization tray system 130j, and then later removed.

[0084] Optional locking mechanism 150 of FIG. 5A may be used to secure optional lid portion 152 to the body of container portion 146. Locking mechanism 150, if provided, may be any suitable means for temporarily securing optional lid 152. Suitable locking mechanisms 150 include clasps, mortise locks, springs, hydraulic pistons, disposable locking means (e.g., stickers, cable ties, tags, etc.). In some examples, the locking mechanism may include an electronic locking system, such as a radio frequency identification device (RFID)-based locking system, a relay-based locking system, an audible alarm-based locking system, and other such systems.

[0085] The optional lid portion 152 of the sterilization tray system 130j may be any suitable lid. The lid may form a seal around the perimeter of the container portion 146 or the tray portion 134j. In such an embodiment, the target may be prevented from spreading contaminants. Additionally or alternatively, the sealable lid 152 may prevent the sterilized target from becoming contaminated. In at least some embodiments, the lid 152 is sealed, but not hermetically sealed. In other embodiments, the lid 152 is hermetically sealed. In some examples, the lid 152 may be formed from a UV-transmissive material, as may any other features of the sterilization tray system 130j (e.g., the locking mechanism 150, the handles 148a, 148b).

[0086] FIG. 5B is a container portion of a sterilization tray system 130. The container portion 146 in the embodiment of FIG. 5B is configured to hold any number of different types of tray portions 134a-134j. When the container portion and tray portion are so combined, the combination of the tray portion 134a and the container portion 146 forms the sterilization tray system 130a, the combination of the tray portion 134b and the container portion 146 forms the sterilization tray system 130b, and so on. It will be appreciated that in such a system, the shape and at least one dimension of the container portion 146 forms at least a portion of the alignment portion 136 that cooperates with the sterilization system 100. In at least one example, a particular sterilization tray system 130 is configured to hold a particular target object. When the particular sterilization tray system 130 is placed in the container portion 146 and the combination is placed in a particular sterilization chamber 102, the target object to be sterilized is aligned as desired with respect to the radiation source 104 located in the particular sterilization chamber 102. Such an arrangement allows the user of the system to more efficiently and reliably disinfect target objects with a high degree of confidence that adequate disinfection has occurred.

[0087] For the avoidance of doubt, the container 146 of Figure 5B may be suitably configured with optional features, including handles 148a, 148b, a locking mechanism 150, a lid 152, and any other such features.

[0088] 6A-6E are embodiments of sterilization systems 100c-100g configured to receive any one or more of the sterilization tray embodiments 130a-130j taught in the present disclosure. As used herein, FIGS. 6A-6E may be collectively referred to as FIG. 6. As used herein, sterilization tray systems 130a-130j taught in the present disclosure may be collectively referred to as sterilization tray system 130. In FIG. 6, many features of sterilization systems 100c-100g are not shown or identified to avoid unnecessarily obscuring other features of interest in the embodiments.

[0089] In FIG. 6A, the sterilization system 100c includes a sterilization chamber 102c configured to receive a sterilization tray system 130. The sterilization tray system 130 is configured to be positioned in a certain alignment (e.g., longitudinal-vertical alignment). One or more alignment features 124a of the sterilization chamber 102c cooperate with one or more corresponding alignment features 124b of the sterilization tray portion 130. The alignment features 124a, 124b are configured to allow a user to quickly, efficiently, and confidently determine that the sterilization tray portion 130 is correctly positioned within the sterilization chamber 102c. The alignment features 124a, 124b may be any type of alignment feature. For example, the chamber base alignment feature may have a first size and shape, and the tray base alignment feature may have a second size and shape that cooperates with the first size and shape. These features may include grooves, rails, posts, openings, protrusions, and any other such physical features. These features may provide tactile, visual, audible, or some other type of active feedback to suggest to the user that the sterilization tray 130 is properly aligned within the sterilization chamber 102c. In these and other examples, the alignment features may comprise electronic circuitry such as, but not limited to, photodiodes, light emitting diodes (LEDs), time-of-flight sensors, wireless signals, inductive circuits, and the like.

[0090] In the embodiment of Figure 6B, the sterilization system 100d includes a sterilization chamber 102d configured to optionally receive a plurality of sterilization tray systems 130. Although three sterilization tray systems 130 are shown in Figure 6B, each of these sterilization tray systems 130 are aligned in a longitudinal-vertical direction. Different numbers of sterilization tray systems 130 with different alignments and orientations are also contemplated.

[0091] Figures 6C and 6D are sterilization systems 100e, 100f, respectively, with horizontally aligned sterilization tray systems 130. In Figure 6C, a single sterilization tray system 130 is disposed within the sterilization chamber 102e, and in Figure 6D, two sterilization tray systems 130 are disposed within the sterilization chamber 102f. Any other number of sterilization tray systems 130 with different alignments and orientations are also contemplated.

[0092] In the disinfection system 100g of FIG. 6E, a disinfection chamber 102g is mounted in a wall. The disinfection chamber 102g has a first opening on the non-clean side of the wall and a second opening on the clean side of the wall. Doors allow access to the interior volume of the disinfection chamber 102g from each side of the wall. In at least one embodiment, a contaminated target is positioned in the disinfection tray system from the non-clean side of the wall. Both doors of the disinfection chamber 102g are closed and a disinfection cycle is performed. The disinfected target is then removed from the disinfection chamber 102g by opening the door on the clean side of the wall.

[0093] In at least some examples of the sterilization system 100g, the doors of the sterilization chamber 102g are intelligently controlled. For example, after a sterilization cycle is performed, the door on the non-clean side is locked and cannot be opened until the door on the clean side of the wall is opened. Circuitry associated with one or more controllers of the sterilization system 100g may be used to determine whether a sterilization tray system 130 is present in the sterilization chamber 102g, and if a tray is present and a sterilization cycle is performed, the circuitry may determine when the sterilized target is removed from the sterilization chamber 102g. Similarly, the circuitry may further prevent both doors of the sterilization chamber 102g from being open at the same time. For example, if the door on the non-clean side of the wall is open, the door on the clean side of the wall is locked and prevented from opening. Of course, other such controls are contemplated.

[0094] Figure 7 is an example controller 160. The controller 160a (Figure 1C) of the sterilization system 100b is formed and constructed similarly to the controller 160 of Figure 7. The controller 160b (Figure 3A) of the sterilization tray system 130a is formed and constructed similarly to the controller 160 of Figure 7. An embodiment of the controller 160 includes a processor 162 and a memory 164. The memory 164 includes software instructions 166 that are executable by the processor to cause the controller to perform certain system operations.

[0095] 7, the controller 160 of the sterilization system 100 includes chamber software executable instructions 166a, and the controller 160 of the sterilization tray system 130 includes tray software executable instructions 166b. In some examples, the executable software 166 includes instructions for both the sterilization system 100 and the sterilization tray system 130, and in other examples, the executable software 166 includes instructions for only one of the sterilization system 100 and the sterilization tray system 130. The dashed lines around the chamber software 166a of the executable software 166 and the dashed lines around the tray software 166b of the executable software 166 indicate that the controller 160 may include one or both of the chamber software 166a and the tray software 166b.

[0096] Memory 164 of controller 160 comprises any number of suitable memory locations for storing parameters 168. Parameters 168 may include temporary stored variables, transient values, and other permanent and transient information generated, stored, consumed, or otherwise associated with executable software 166, processor 162, and controller 160 or any other logic circuitry associated therewith.

[0097] Optionally, controller 160 may include a user interface 170, a sensor interface 172, and a communication interface 174. Controller 160 also includes other desired circuitry. A non-limiting and non-exhaustive list of at least some of the other desired circuitry includes power supply circuits, clock circuits, memory interfaces, and bus structures for electrically and communicatively coupling to various hardware circuits. In FIG. 7, the other desired circuitry is not shown to avoid unnecessarily complicating the embodiment.

[0098] The user interface 170 may include any suitable number of human interface devices (HIDs). In some examples, the controller 160 does not have an HID device. The user interface 170 may include audio, visual, tactile, and other such circuits. A non-limiting list of HID means includes a display screen, a keyboard, a computer mouse, touch screen circuits, speakers, piezoelectric devices, vibrators, LEDs, and other such circuits.

[0099] In some examples, the user interface 170 may include at least one clean / not clean indicator, such as a green "clean" LED and a red "not clean" LED. The user interface 170 may include a last clean time indicator that displays or otherwise conveys time, date, or time and date information reporting when a particular target object 120 was sanitized, and the user interface may further include a sanitization expiration indicator. The sanitization expiration indicator may be used to indicate when the target object 120 should be re-sanitized.

[0100] In some examples, the user interface 170 may include any desired number of "aligned" and "not aligned" indicators. The aligned and not aligned indicators (i.e., alignment indicators) may indicate the alignment status of any portion of the target object 120 within the receptacle portion 138 of the sterilization tray system 130. These or other aligned and not aligned indicators may additionally or alternatively indicate the alignment status of the sterilization tray system 130 within the sterilization chamber 102. The alignment indicators may be visual alignment indicators, such as a template, outline, or image of the target object to be sterilized, which are formed or otherwise disposed within the receptacle portion 138 of the sterilization tray system 130. The alignment indicators may be electronic circuitry (e.g., paired RF transceivers, electrical conduction circuitry, optical alignment circuitry, etc.) that indicates proper alignment of components or portions of components. The alignment indicators may be tactile structures, such as protrusions and corresponding indentations of any suitable shape.

[0101] The sensor interface 172 is configured to send control information to, receive data from, or send control information to and receive data from one or more sensors. The sensors may be ultraviolet (UV) radiation sensors (e.g., photodetectors), and in some of these examples, the UV sensors may be tuned for a particular UV frequency (e.g., UV-A radiation, UV-B radiation, or UV-C radiation). The sensors may be time-of-flight sensors. In some examples, the sensors comprise non-electronic sensors, such as UV-sensitive materials (e.g., paint that changes color when exposed to a particular type of radiation, such as UV radiation). When the non-electronic sensor is a UV-sensitive material, the UV-sensitive material may change its appearance (e.g., color, brightness, or texture, etc.) in proportion to the amount of radiation impinging on the sensor's surface (e.g., a first amount of radiation may change a white material to a pink material, a second, higher amount of radiation may change the material to a red material, etc.). Other sensors, such as closed door sensors, open door sensors, and radiation source failure sensors, are also contemplated.

[0102] The communication interface 174 may be coupled to any one or more suitable data communication circuits. Data communication may include, for example, wired or wireless serial communication circuitry, WiFi (i.e., 802.11 compatible) circuitry, Ethernet circuitry, mobile communication circuitry, inductive communication circuitry, and any other suitable circuitry. The communication interface may be configured for bidirectional or unidirectional communication. The communication interface 174 of the sanitization tray system 130 may be configured for communication with a corresponding communication interface 174 of the sanitization system 100. In some examples, two or more sanitization tray systems 130 may communicate with each other. In some examples, two or more sanitization systems 100 may communicate with each other. In some examples, the communication interface 174 is configured to communicate with a wide area network (WAN), such as the Internet. In some examples, communication between associated devices of the present disclosure is facilitated by sending information via an alternate communication medium (e.g., a WAN, a local area network (LAN), or some other network).

[0103] The chamber software 166a and the tray software 166b comprise software instructions executable by the processor 162. The chamber software 166a and the tray software 166b may be organized as a set of logical modules in some cases. In some examples, the logical modules of the executable software 166 may further comprise associated circuitry (e.g., switches, multiplexers, buffers, sensors, interface circuits, clock circuits, power circuits, compression / decompression circuits, encryption / decryption circuits, etc.). In at least some examples, one or more logical modules of the chamber software 166a are identical to one or more modules of the tray software 166b. In some examples, one or more of the logical modules of the executable software 166 are shared by the chamber software 166a and the tray software 166b.

[0104] The chamber software 166a includes an identification module 176a, a sterilization module 178a, an alignment module 180a, a door control module 182a, a sensor control module 184a, and an additional logic module 186a. The tray software 166b includes an identification module 176b, a sanitized tray module 178b, an alignment module 180b, a time information module 182b, a sensor control module 184b, and an additional logic module 186b.

[0105] Each type of target object 120 may have a unique and specific type identifier. Each specific target object 120 may have a unique identifier. Similarly, each sterilization tray system 130 may have a unique and specific type identifier, and each sterilization tray system 130 may have a unique identifier. The unique identifier may be configured as a serial number or some other such identifier. Similarly, each type of sterilization system 100 may have a unique and specific type identifier, and each sterilization system 100 may have a unique identifier. Thus, the term identification information as used herein may include any or all of: 1) target object type identifier, 2) sterilization tray system type identifier, 3) sterilization system type identifier, 4) target object identifier, 5) sterilization tray system identifier, and 6) sterilization system identifier. Any or all of this identification information is appropriately managed by one or both of the identification module 176a of the chamber software 166a and the identification module 176b of the tray software 166b. The identification information may be established by the manufacturers of the sterilization system 100, the sterilization tray system 130, and the target object 120, as the case may be. The identification information may be stored in a hardware circuit, in a read-only portion of memory, or in some other manner. The identification information may be encrypted or in clear text.

[0106] The identification module 176a of the chamber software 166a is associated with a particular identification of the sterilization system 100. The identification module 176a is configured to verify that a particular operation of the sterilization system 100 can be performed based on the identification. For example, the executable software 166 may store a number of sterilization algorithms (e.g., 10, 50, 500), but only some of the sterilization algorithms are suitable for execution in a particular sterilization chamber 102, and a determination of whether a sterilization algorithm is suitable for the sterilization system 100 may be based on the identification. Additional information related to the identification may be communicated to or from the sterilization system 100 via the communication interface 174 under the direction and control of the identification module 176a. In at least some examples, the identification information is accessible via a wide area network (e.g., the Internet). The identification information may be associated with other information of the sterilization system 100, such as, but not limited to, the age of the radiation source 104, the number and type of radiation sensors 126, the number and type of alignment features, sterilization tray compatibility information, sterilization cycle metadata (e.g., number of sterilization cycles performed, date and time information, identification information related to the target object or sterilization tray, errors, and interrupted sterilization cycles, etc.), size and shape of the interior volume 114, and suspension assembly information. Other types and uses of sterilization chamber 102 identification information as managed by the identification module 176a are also contemplated.

[0107] The identification module 176b of the tray software 166b is associated with a particular identification of the sterilization tray system 130 and one or more target objects 120. In some examples, the identification module 176b and the communication interface 174 cooperate to transmit the sterilization tray identification to the sterilization system 100. In these examples, the sterilization system 100 may verify whether a particular sterilization tray system 130 is compatible with the sterilization system 100. In these examples, the sterilization system 100 may verify whether a particular target object to be positioned within the sterilization tray system 130 is compatible with the sterilization system 100.

[0108] The identification module 176b of the sterilization tray system 130 may cooperate with the identification module 176a of the sterilization system 100 to maintain current information regarding the sterilization status of one or more sterilization tray systems 130 and additionally or alternatively one or more particular target objects 120. When a particular sterilization tray system 130 or a particular target object 120 is sterilized, for example, associated identification information and additional metadata may be recorded, which may enable subsequent audit or other analysis to determine when a device was sterilized, the success or failure of sterilization, the parameters of the sterilization cycle, the particular sterilization system 100 performing the sterilization cycle, and other such information.

[0109] Based on the identification information, the identification module 176b is configured to verify that certain sterilization parameters are met. The identification module 176b may determine the type of target object 120 stored in a receptacle of the sterilization tray system 130. The identification module 176b may determine the identity of the target object 120 stored in a receptacle of the sterilization tray system 130. The identification module 176b may determine whether the target object 120 is properly aligned in the sterilization tray system 130.

[0110] The sterilization module 178a of the chamber software 166a is configured to manage sterilization cycles in the sterilization system 100. The sterilization module 178a may direct or otherwise control a timed sterilization algorithm, a radiation sensor based sterilization algorithm, or a different type of sterilization algorithm. In some examples, the sterilization algorithm may be selected or otherwise controlled based on the identity of the sterilization tray system 130 or the identity of the target object.

[0111] The sanitized tray module 178b of the tray software 166b is configured to determine or otherwise maintain information regarding a sanitization cycle that is to be performed or has been performed on the sanitization tray system 130. The sanitized tray module 178b may maintain metadata that represents, for example, when a sanitization cycle was performed, whether the sanitization cycle was completed, whether the lid portion 152 of the sanitization tray system 130 was opened due to the performance of a sanitization cycle, and whether any other specified conditions were met.

[0112] The alignment module 180a of the chamber software 166a and the alignment module 180b of the tray software 166b may operate individually or in concert to determine whether the target object is properly aligned within the receptacle portion 132 and whether the sterilization tray system 130 is properly aligned within the sterilization chamber 102. The alignment modules 180a, 180b may work cooperatively with the sensor interface 172 and one or more alignment features 124. Alignment of alignment features (e.g., mechanical alignment features, electromechanical alignment features, electronic alignment features) between the sterilization tray system 130 and the sterilization chamber 102, between the target object 120 and the receptacle 132, or between any other parts of the system of interest may be determined based on optical circuitry (e.g., photodetectors and LEDs, etc.), wireless circuitry (e.g., radio frequency (RF) transmitter / receiver pairs), electrical continuity circuitry, or any other such circuitry. The operation of such circuits and the determination of alignment are performed in one or both of the alignment modules 180a, 180b.

[0113] One or both of the alignment modules 180a, 180b may generate or otherwise send output alert information to a user of each system via the user interface 170. The output information is provided to indicate to the user that at least one of proper alignment and improper alignment conditions exist or exist. The output alert information may be any one or more of audio information (e.g., buzzer, piezoelectric device, bell, and speaker delivered alert, etc.), visual information (e.g., light emitting diode (LED) illumination and screen message, etc.), or tactile information (e.g., vibrator or piezoelectric buzzer, etc.). In some examples, the alignment modules 180a, 180b provide information into the other circuitry of the sterilization system 100 and the sterilization tray system 130 that is prerequisite for the sterilization process to be performed. That is, in some examples, the sterilization process is performed only when the associated alignment modules 180a, 180b determine that the target object 120, the sterilization tray system 130, and the sterilization system 100 are all properly aligned. In at least one example, the alignment determination is generated within a range from "insufficient alignment" to "sufficient alignment," and this range is used to control the length of time that a portion of the sterilization process will be performed. In effect, if the alignment is determined to be a first numerical value, then the sterilization process may be performed for a first time interval, and if the alignment is determined to be a second numerical value that is higher than the first numerical value, then the sterilization process may be performed for a second time interval that is shorter than the first time interval. In some examples, such operations are facilitated by one or both alignment modules 180a, 180b.

[0114] The door control module 182a of the chamber software 166a may be used to lock the sterilization chamber door 112, unlock the sterilization chamber door 112, and alternatively or additionally provide an indication of the locked / unlocked status of the sterilization chamber door 112. The door control module 182a may direct the operation of the interlock mechanism 112a. Additionally or alternatively, the door control module 182a may receive status information from the interlock mechanism 112a. In some examples, such as in the embodiment of FIG. 6E, the door control module 182a controls and receives information from multiple doors of the sterilization system 100.

[0115] The time information module 182b of the tray software 166b may be used to determine when the target object 120 is aligned within the sterilization tray module. In these or other examples, the time information module 182b may be used to determine the amount of time the sterilization tray system 130 has been exposed to radiation. The time information module in these or still other examples may be used to determine the amount of time the lid portion 152 of the sterilization system 100 has been opened, closed, or opened and closed.

[0116] The sensor control module 184a of the chamber software 166a and the sensor control module 184b of the tray software 166b may operate separately or cooperatively. The sensor control modules 184a, 184b may enable and disable sensors, load parameters into the sensors, receive data from the sensors, and provide and receive any other information related to the sensors. The sensor control modules 184a, 184b facilitate communication of control information and data via the sensor interface 172. A non-limiting list of sensors that may be associated with the sensor control modules 184a, 184b includes radiation sensors, door closure sensors, alignment sensors, keyboards, computer mice, touch screens, and other human interface devices. Of course, still other sensors are also contemplated.

[0117] The additional logic modules 186a, 186b of the chamber software 166a and the tray software 166b perform further functions. Such logic may control or receive information from clock circuits, output measurement circuits, the user interface 170, the communication interface 174, and further circuits. The additional logic modules 186a, 186b may further provide software instructions that, when executed by the processor 162, implement further functions of the sterilization system 100 and the sterilization tray system 130, respectively.

[0118] 8 is a data flow diagram 800 illustrating a method for aligning a target object 120 to be sterilized within a sterilization tray system 130, positioning the sterilization tray system 130 within the sterilization system 100, and sterilizing the target object 120. Processing in data flow diagram 800 begins at 802 and proceeds to 804.

[0119] At 804, a user (e.g., a medical practitioner, a scientist, a manufacturer, or some other user) may determine that a target object 120 is to be sterilized. The target object to be sterilized may be any particular type of probe, such as a probe used in a medical environment, a dental instrument, a device used in the development or manufacture of electronic components, a device used in pharmaceutical manufacturing, a cable, a handle, or any other device that the user determines should be sterilized.

[0120] The user then selects a sterilization tray system 130 and aligns the target object 120 to be sterilized within the receptacle portion 138 of the tray portion 134 of the sterilization tray system 130. The tray portion is formed from a UV-transmissive material. The UV-transmissive material may include one or more of plastic, vinyl, glass such as quartz, gel, polymer, polymethylmethacrylate (PMMA), polystyrene, or some other UV-transmissive material. In some examples, the UV-transmissive material may have at least fifty percent (50%) UV transmission, at least seventy-five percent (75%) UV transmission, at least ninety-five percent (95%) UV transmission, or up to some other level of UV transmission.

[0121] The sanitization tray system 130 may be a molded, blow molded, laser cut, thermoformed, cast, machined, or otherwise formed structure. In some examples, the sanitization tray system 130 may be configured for single use. That is, in some examples, the sanitization tray system 130 is a disposable device. In other examples, some portions of the sanitization tray system 130 are configured for single use (e.g., disposable portions). In still other examples, some or all portions of the sanitization tray system 130 are reusable.

[0122] The sterilization tray system 130 may be configured with a receptacle portion 138. The receptacle portion 138 has a defined shape (e.g., the shape of the target object 120 to be sterilized) and defined dimensions (e.g., the size of the target object 120 to be sterilized). The receptacle portion 138 may have any number of different sections recessed into the surface of the tray portion 134. Alternatively, the receptacle portion may include one or more alignment receptacle portions, such as clips or some other restraining means. The surface of the tray portion 134 may include a template, contour, an image of the target object to be sterilized, or some other visual alignment means to guide the user for proper placement of the target object to be sterilized within the sterilization tray system 130.

[0123] In some examples, the receptacle portion 138 of the sterilization tray system 130 may include alignment features that mate with or otherwise cooperate with selected portions of the target object 120 to be sterilized. For example, when the receptacle 132 is embedded into the surface of the tray portion 134, the receptacle may have one or more primary receptacle portions 138a, one or more secondary receptacle portions 138c, one or more alignment receptacle portions 138b, and any other number of suitable portions. In at least some examples, the receptacle 132 may include one or more alignment receptacle piercing portions 142 that may allow a cable, hose, or some other portion of the target object 120 to be sterilized to extend beyond the boundaries of the tray portion 134.

[0124] At 806, and in combination with the processing at 804, a determination is made as to whether the target object 120 to be sterilized is properly aligned within the receptacle portion 138 of the sterilization tray system 130.

[0125] When a user aligns a target object 120 to be sterilized within the receptacle portion 138, proper alignment of the target object 120 may be determined visually, tactilely, electronically, or in some other manner. For example, the receptacle portion may define a low tolerance notch (e.g., within 50 millimeters, within 10 millimeters, within 2 millimeters, or within some other tolerance between the boundary of the target object and the corresponding boundary of the receptacle). The low tolerance notch allows a user to know tactilely whether the target object 120 is properly aligned within the sterilization tray system 130.

[0126] Additionally or alternatively, the sterilization tray system 130 may include electronic means for determining that the target object 120 to be sterilized is properly aligned within the receptacle portion 138. The electronic means may include an optical pair, a radio frequency receiver / transmitter pair, an electrical connection point, or any other electronic circuitry configured to determine that the target object 120 is properly aligned.

[0127] In yet other examples, proper alignment is achieved by the user visually monitoring that the target item to be sterilized is placed within the receptacle portion according to written instructions, a template, or a visual indication printed or otherwise displayed on the sterilization tray system 130, such as within the boundaries of the receptacle portion 138.

[0128] A sanitization tray system 130 of the type taught in this disclosure may optionally include a controller, such as the controller 160 of FIG. 7. The controller 160 may be configured as an electronics module having a communication interface, a user interface (e.g., a voice interface, a visual interface, or a tactile interface, etc.), at least one clean / not clean indicator (e.g., a color-coded indicator, a flashing / non-flashing indicator, an audible / silent indicator, or some other indicator), a last clean time indicator, a sanitization "expired / not expired" indicator, a repository or circuitry for serial numbers or some other identifiers, an encryption / decryption module, and any other suitable circuitry. In some examples, the electronics module may be hermetically sealed within the tray portion 138. In other examples, the electronics module may be mountable to or near the sanitization tray system 130.

[0129] The electronics module is configured to communicate identifying information associated with the target object 120 to be sterilized, along with any other desired information, from the sterilization tray system 130 to the sterilization system 100. The electronics module may also communicate such information to some other computing device, such as a computing server communicatively coupled to a network, such as the Internet.

[0130] If the target object 120 to be sterilized is properly aligned within the sterilization tray system 130, the process proceeds to 808. If the target object 120 to be sterilized is not properly aligned within the sterilization tray system 130, the process of 806 returns to 804.

[0131] Processing continues to 808 where a particular sterilization system 100 is selected to receive the sterilization tray system 130. At 808, the sterilization tray system 130 is aligned within the sterilization system 100 and at 810, a determination is made as to whether the sterilization tray system 130 is properly aligned within the sterilization system 100.

[0132] In some examples, alignment of the sanitization tray system 130 includes positioning the sanitization tray system 130 in the sanitization chamber 102 using one or more handle structures integrated or coupled with the sanitization tray system 130. In some examples, the sanitization tray system 130 comprises at least two handles. In these examples, each handle is configured to removably couple to a corresponding handle mounting structure. For example, the handles may comprise hooks or clamps or the like that fit into holes, loops, or some other structure of the sanitization tray system 130.

[0133] To aid in alignment, the sterilization tray system 130 may include an alignment portion having a defined shape and defined dimensions. The defined shape may be the shape of the tray portion 134 of the sterilization tray system 130. Exemplary but non-limiting shapes include a cuboid, which may be defined as a cube or rectangular prism, a rectangular parallelepiped, a convex polyhedron bounded by six quadrilateral faces, a rectangular box, or any other similarly defined body. Other geometrically simple shapes (e.g., spherical, pyramidal) are also contemplated. Other complex shapes are also contemplated. In some examples, the defined shape is selected to achieve line-of-sight exposure, closer exposure, or some other exposure element of one or more selected portions of the target object 120 to be sterilized to one or more radiation sources 104 of the sterilization system 100. For example, the shape of the sterilization tray system 130 may be selected in whole or in part to place the "front" (i.e., patient-contacting) portion of the medical probe in line-of-sight proximity to a particular radiation source 104 within the sterilization system 100.

[0134] In some examples, if an optional first electronics module (e.g., controller 160) is included in the sterilization tray system 130, the first electronics module is configured to communicate with a corresponding second electronics module (e.g., controller 160) of the sterilization system 100. The first electronics module communicates identification information to the second electronics module, thereby informing the sterilization system 100 of the identity (e.g., serial number, type of target) of the target 120 to be sterilized. Other information may also be communicated between the first and second electronics modules.

[0135] The sanitization tray system 130 may optionally include an alignment portion having any number of alignment features. The alignment features may comprise a shape and one or more dimensions associated with the sanitization tray system 130. The alignment features may further comprise any number of optional physical alignment structures or electronic circuitry that aid in alignment of the sanitization tray system 130 within the sanitization chamber 102 of the sanitization system 100.

[0136] In at least some examples, particularly where the alignment of the sanitization tray system 130 within the sanitization system 100 is determined electronically, alignment information may be communicated between the sanitization tray system 130 and the sanitization system 100. The alignment information may be an indication that these structures are properly aligned. Alternatively, the alignment information may be that these structures are not properly aligned. Based on the alignment information, the user may be alerted by an audio indicator, a visual indicator, a tactile indicator, or some other indicator. Such information may be appropriately communicated between the sanitization tray system 130 and the sanitization system 100 in some examples.

[0137] If the sterilization tray system 130 is properly aligned within the sterilization system 100, processing proceeds to 812. If the sterilization tray system 130 is not properly aligned within the sterilization system 100, processing of 810 returns to 808.

[0138] At 812, a sterilization protocol is selected by the sterilization system 100 based on one or both of the sterilization tray system 130 and the target object 120 to be sterilized, and the sterilization protocol is performed. Some or all portions of the sterilization tray system 130 are formed from a radiotransparent material, allowing radiation from the radiation source 104 to pass through the sterilization tray system 130 and reach the target object 120, sterilizing the target.

[0139] The sterilization protocol may enable one or more radiation sources 104 based on time, radiation delivered to one or more radiation sensors, or some other function. In some examples, when the target object 120 is known, the sterilization protocol may specifically control one or more radiation sources 104 to achieve a particular sterilization outcome. For example, one or more radiation sources 104 in the sterilization chamber 102 may be enabled for a longer period of time than other radiation sources 104 in the sterilization chamber 102. Additionally or alternatively, one or more radiation sources 104 in the sterilization chamber 102 may be pulsed or enabled in other manners to prevent overheating of portions of the target object 120.

[0140] In some examples, radiation sensors embedded in or otherwise associated with the sterilization tray system 130 provide information to the sterilization system 100 regarding the continuation or termination of the sterilization protocol. In these examples, for example, the sterilization tray system 130 collects radiation sensor information and communicates the radiation sensor information to the sterilization system 100. The sterilization system 100 may use this radiation sensor information to determine when to terminate the sterilization process, when to extend the sterilization process, and when to modify the sterilization process. One example of modifying the sterilization process includes enabling the first one or more radiation sources 104 for an extended period to continue emitting radiation, and simultaneously disabling the second one or more radiation sensors 104 to terminate the emission. In this manner, a first selected portion of the target 120 is allowed to continue receiving direct line-of-sight radiation, and a second selected portion of the target 120 stops or reduces the amount of direct line-of-sight radiation it receives.

[0141] If the sterilization system 100 determines at 814 that the sterilization protocol is complete, then processing proceeds to 816. Alternatively, if the sterilization protocol is not complete, then processing returns to 812.

[0142] At 816, the sanitization tray system 130 and / or the sanitization system 100 report the success or failure of the sanitization process, and the sanitization tray system 130 and / or the sanitization system 100 can optionally generate metadata related to the sanitization process. The success or failure may be reported electronically via a user interface (e.g., audio alert or visual indicator, etc.). The success or failure may additionally or alternatively be reported via a physical medium, such as a radiation sensitive material as taught in this disclosure. The radiation sensitive material may be integrated with, coupled to, or otherwise associated with the sanitization tray system 130.

[0143] The metadata generated at 816 may comprise timing information, such as a timestamp and date / time stamp that identifies when the sterilization process was performed. The timing information may be specifically coupled or otherwise associated with an identity of the target object 120, the sterilization tray system 130, or both the target object 120 and the sterilization tray system 130. In at least some examples, the sterilization tray system 130 comprises a mechanically sealable case (e.g., container 146) configured to hold at least one tray portion 134. The mechanically sealable case may be used to store the target object 120 for hours, days, weeks, months, or some other time interval. In these and at least some other examples, the metadata optionally comprises sterilization expiration timing information. This sterilization validity timing information informs the user when the target object 120 should be re-sterilized if the target object 120 has not been used.

[0144] Still other metadata may be collected and communicated in any useful manner. Other metadata may include dynamically changed parameters of the sterilization process. Such information may be used to detect immediate or impending problems with the sterilization tray system 130 and the sterilization system 100. Other metadata may include the number of times a particular target object 120 has been sterilized, the number of times a particular sterilization tray system 130 has been sterilized, the cumulative radiation dose collected by the radiation sensor, the sterilization process duration, and any other information related to the sterilization process.

[0145] Processing continues from 816 and ends at 818 .

[0146] In the foregoing, a number of specific details are set forth to facilitate a thorough understanding of various disclosed embodiments. However, one of ordinary skill in the art will appreciate that the embodiments may be practiced without one or more of these specific details, or with other methods, components, materials, etc. In other instances, well-known structures associated with computing systems and networks, including client and server computing systems, have not been shown or described in detail to avoid unnecessarily obscuring the description of these embodiments.

[0147] Returning to FIG. 1, each radiation source 104 may emit radiation according to its own parameters and characteristics. For example, the age of the radiation source 104 may be directly related to its light emission characteristics. Furthermore, the time that has elapsed since the radiation source was switched on may also affect the UV-C radiation emitted from the radiation source 104. For example, the intensity of the radiation emitted by the radiation source 104 may be time-dependent as part of its natural operation and may have a certain pattern of waveform / change, such as a continuous decrease, a continuous increase, or a fluctuation. Furthermore, each radiation source 104 may have various operating states in which it emits radiation. For example, each radiation source 104 may have characteristics that cause each source to emit radiation at different output levels, even if the output of two or more radiation sources 104 would otherwise be expected to be the same. Also, each radiation source 104 may emit radiation at various angles that are substantially parallel to one another, or in a combination of operating positions. Multiple radiation sources may be controlled with a common signal and common parameters. Alternatively, two or more radiation sources may be individually controlled with separate control signals and parameters.

[0148] The sterilization chamber 102 as described herein may be configured to form multiple sterilization zones within the interior volume 114. In such embodiments, the sterilization chamber 102 and / or the one or more targets 120 to be sterilized may be further configured such that the one or more targets 120 to be sterilized are positioned within the sterilization zone at a selected position, alignment, orientation, etc. As used herein, the term "sterilization zone" refers to an area within the sterilization chamber to which a particular sterilization radiation intensity is delivered over the course of a sterilization process. In certain embodiments, the interior volume 114 is coupled to one or more UV-C radiation sources 104 that provide radiation at a variety of radiation intensities, i.e., at least about 1,500 μW / cm, for example. 2The disinfection zones may be selected and configured to individually or commonly deliver UV-C radiation to the disinfection zones at an irradiance (also referred to as "power" for or through a particular unit of area), such as 100 irradiance, ...

[0149] In some embodiments, the one or more UV-C radiation sources 104 may be selected to emit UV-C light within a band selected from between about 240 nm and about 270 nm and between about 255 nm and about 265 nm. For example, the one or more UV-C sources 104 may be configured to emit UV-C light within a band selected from between about 240 nm and about 270 nm and between about 255 nm and about 265 nm, such that one or more sterilization zones are formed within the sterilization chamber and the radiant intensity ("irradiance") of UV-C radiation delivered to the one or more sterilization zones is about 1,500 μW / cm 2 ~Approx. 5,000μW / cm 2 In a further embodiment, the one or more UV-C sources 104 may be selected and configured to provide one or more disinfection areas, in which the irradiance of UV-C radiation delivered within the disinfection area is between about 1,500 μW / cm 2 ~Approx. 2,000μW / cm 2 Approximately 1,500 μW / cm 2 ~Approx. 2,500μW / cm 2 Approximately 1,500 μW / cm 2 ~Approx. 3,000μW / cm 2 Approximately 2,000 μW / cm 2 ~Approx. 2,500μW / cm 2 Approximately 2,000 μW / cm 2 ~Approx. 3,000μW / cm 2 Approximately 2,000 μW / cm 2 ~Approx. 3,500μW / cm 2 Approximately 2,000 μW / cm 2 ~Approx. 2,500μW / cm 2 Approximately 2,000 μW / cm 2 ~Approx. 2,750μW / cm 2 Approximately 2,500 μW / cm 2 ~ approx. 2,600 μW / cm2 Approximately 2,500 μW / cm 2 ~Approx. 2,750μW / cm 2 Approximately 2,500 μW / cm 2 ~Approx. 3,000μW / cm 2 or other similar values.

[0150] In some embodiments, the disinfection zone formed within the interior volume 114 is characterized by a disinfection radiation delivery at a substantially uniform irradiance within the zone. The term "substantially uniform" as used herein in connection with a disinfection zone refers to a zone in which the irradiance of the disinfection radiation does not vary by more than 10% within the entire zone (i.e., the irradiance measured within the zone does not vary by more than 10%). In certain embodiments, "substantially uniform surface irradiance" refers to a disinfection zone in which the intensity with which the disinfection radiation is delivered to the surfaces of the objects to be disinfected does not vary in any portion of those surfaces by more than an amount selected from ±30%, ±25%, ±20%, ±15%, ±10%, and ±5%, or another similar value. The disinfection zones may be redefined or custom adjusted for different types of targets 120, for different regions of the targets 120 to be disinfected, for different operating conditions of the radiation source 104, or for other reasons. Additionally, these disinfection zones may be dynamically adjusted, collectively adjusted, individually adjusted, or adjusted in some other manner. For example, if it is determined that the difference in radiation intensity within the sterilization area exceeds a threshold, such as 10%, the sterilization area may be redefined into two or more sterilization areas, for example according to a generated sterilization program or some other logic.

[0151] Disinfection does not require that radiation be delivered uniformly, but it may be useful to have a reasonably uniform irradiation within the local volume / region in which the target 120 is located. The uniform distribution may be used to ascertain the actual power level established where one or more surfaces of the target 120 are to be disinfected. For example, the radiation dose that would reach one or more surfaces in a selected volume or region if the selected volume or region were uniformly irradiated may be estimated from radiation measurements of sensors in the selected volume or region. In this way, the minimum radiation dose determined to achieve the desired disinfection level may be delivered to the intended surfaces, reducing the possibility of overexposure.

[0152] Also, one or more interior walls defining the interior volume 114 of the disinfection chamber 102 may be configured to cooperate with one or more disinfecting radiation sources 104 to deliver high intensity disinfecting radiation to one or more disinfecting regions within the interior volume 114. For example, one or more walls and, if present, one or more reflective surfaces included within the disinfection chamber may be configured to function in cooperation with one or more disinfecting radiation sources 104 to form one or more disinfecting regions. In some embodiments, the interior volume of the disinfection chamber is defined by one or more side walls along with a top wall and / or a bottom wall. In such embodiments, the disinfecting radiation source 104 may be positioned on or in any side wall, top wall, bottom wall, or at any junction between any of two or more side walls, between a side wall and a bottom wall, and between a side wall and a top wall. Additionally or alternatively, the generated sterilization program may control the one or more radiation sources 104 to deliver one or more desired levels of radiation to one or more various sterilization zones defined within the interior volume 114 of the sterilization chamber 102. The radiation intensity delivered to one sterilization zone may be different from the radiation intensity delivered to another sterilization zone simultaneously.

[0153] The one or more walls defining the interior volume 114 of the sterilization chamber 102 may provide any one of a number of cross-sectional shapes for the chamber. For example, in certain embodiments, the one or more walls are configured to provide the interior volume 114 with a circular cross-section or a polygonal cross-section, such as a rectangular cross-section, a triangular cross-section, a hexagonal cross-section, or an octagonal cross-section. In some embodiments, the sterilization chamber 102 is configured such that the interior volume 114 is defined by a plurality of walls, and the cross-sectional shape of the interior volume is a rectangular parallelepiped or an octagonal prism. In still other embodiments, the interior volume 114, or portions thereof, may be shaped as a circle, a parabola, a double ellipse, or some other shape. In some examples, the interior walls of the interior volume 114 may be added, removed, or alternatively or additionally repositioned such that a sterilization chamber having an interior volume defined by a first cross-sectional shape is modified to have an interior volume defined by a second, different cross-sectional shape.

[0154] An embodiment of the disinfection chamber 102 may include a reflector (not specifically shown for simplicity) behind the disinfection radiation source(s) 104, either fully or partially; in such an embodiment, if the disinfection radiation source 104 emits UV radiation and is a linear source, such as a tube emitting UV-C radiation, the reflector may be parabolic with the UV-C radiation source at or near its focus. Such a configuration may result in light being delivered as approximately parallel rays on initial reflection from the parabolic reflector. Of course, other reflector shapes, UV radiation source positions, and resulting radiation fields are also possible. In the case where a tube emitting UV-C radiation is used as the disinfection radiation source(s), the total rated power delivered by the source tube (i.e., the UV-C fluence leaving the source integrated over the surface area encompassing the source) may be in the range of about 20 W to about 200 W in some embodiments. It is noted that the input power consumed by the disinfecting radiation sources 104 (e.g., UV tubes) is related to and informative of the output UV power delivered from these sources, but this relationship is not linear and typically changes over time. However, in certain embodiments, the input power for UV tubes used in disinfection chambers as described herein may be selected from, for example, 20W, 25W, 30W, 35W, 40W, 45W, 50W, 55W, 60W, 65W, 70W, 75W, 80W, 85W, 90W, 95W, 100W, 135W, 150W, or another similar value.

[0155] The one or more disinfecting radiation sources 104 may be positioned around one or more sidewalls of the interior volume 114 to result in a selected intensity of radiation (e.g., energy as described in connection with disinfection regions) being delivered to one or more disinfection regions within the interior volume 114. The one or more disinfecting radiation sources 104 may be positioned around the interior volume 114 to provide a particular radiation intensity to the disinfection regions. For example, in an embodiment of an interior volume 114 having one or more sidewalls, two or more disinfecting radiation sources 104, such as two or more UV-C radiation sources 104, may be positioned along one or more of the sidewalls at evenly spaced locations. In an embodiment having multiple sidewalls, the one or more disinfecting radiation sources 104 may be positioned at one or more corners of the sidewalls. In cases where the disinfection chamber comprises at least one top or bottom wall or surface, the one or more disinfection radiation sources 104 may be positioned on the top and / or bottom wall or surface to achieve a certain level of disinfection radiation irradiance delivered into one or more disinfection areas formed within the interior volume 114. In certain embodiments, when the interior volume 114 of the disinfection chamber 102 is configured to comprise two or more side and bottom walls, a UV radiation source 104 located at each corner is formed between the side walls and at least one UV radiation source 104 positioned on the bottom wall, and the input power of each corner tube may be at least 50 W, and the output of the bottom tube or tubes, if included, may be at least 30 W.

[0156] To facilitate positioning of the target 120 within the interior volume 114, the sterilization chamber 102 can include a movable base, such as a suspension assembly, that positions one or more targets 120, such as an ultrasound probe or other medical instrument, within the chamber. The suspension assembly as described herein serves to consistently position the target or targets 120 to be sterilized within the sterilization chamber. In those cases where the sterilization chamber is designed to form one or more sterilization zones, the provision of a suspension assembly allows for consistent and reproducible positioning of the target or targets to be sterilized within the sterilization zones, thereby ensuring that the target or targets are exposed to high intensity radiation during a sterilization cycle.

[0157] As will be appreciated, the location of the interior volume 114 with its shape and size, the location, shape, and light reflecting properties of the reflective interior sidewalls that define the interior volume 114, the quantity and location of the radiation sources 104, the motion of the movable base, and other structural configurations of the interior volume 114 can all affect the radiation intensity delivered to the disinfection area within the interior volume 114. In the present description herein, any such structural configuration of and / or within the interior volume 114 will be referred to as the "structural configuration" of the interior volume 114.

[0158] Additionally, the number and positioning of the one or more sensors 126 included in the sterilization system 100 are selected to achieve high-level sterilization at high speed and low temperature. In this description, the sensor 126 includes any device or component assembly that collects and measures environmental conditions. When referring to the one or more sensors 126 for detecting sterilization radiation in the sterilization chamber, each of the one or more sensors 126 is a device or component assembly that can collect information about the sterilization radiation present in the sterilization chamber, sense or measure the amount of sterilization radiation in the sterilization chamber, and amplify or process the collected information about the sterilization radiation. Furthermore, in the context of this description, the sensor 126 is considered to be positioned in the sterilization chamber 102, and regardless of whether the sensor 126 is positioned in the sterilization chamber or directly exposed to the interior of the sterilization chamber, any component of the sensor 126 can detect, measure, transmit, process, or communicate the processed information about the sterilization radiation present in the sterilization chamber.

[0159] Each of the one or more sensors 126 included in the interior volume 114 may be capable of detecting and communicating information such as total radiation dose and exposure rate over time to the controller 160. For example, if UV-C light is used as the disinfecting radiation, the sensor 126 may sense the UV-C dose received by the target 120 and / or the UV-C radiation emitted by one or more UV-C sources 104 included in the disinfection device. In some embodiments, the UV-C sensor 126 included in the disinfection device described herein may be or otherwise include one or more photodiodes fixedly or movably positioned in the interior volume 114 of the disinfection chamber 102. In these and other embodiments, the one or more sensors 126 may include one or more photoconductive components such as lenses, mirrors, filters, and other optical elements used to collect radiation within the chamber, and may further include fiber optic cables or light guides that conduct the collected disinfection energy to a detector such as a photodiode. The sensor 126 may be a stand-alone sensor, or the sensor 126 may be formed as a combination of separate structures, such as, for example, a fiber optic probe (FOP), that includes at least one photoconductive element and at least one photoelectric sensor coupled to a common structure. In some variations, the sensor 126 in the sterilization chamber 102 is configured to have a bandpass optical filter or other electromagnetic filter on the front surface, such that only radiation within the spectrum of interest is sensed. In some embodiments, the sensor(s) 126 may be positioned on or incorporated into the target(s) to be sterilized. Positioning the sensor(s) 126 on the target(s) 120 to be sterilized may allow for a more accurate reading of the sterilization radiation reaching the target(s) 120. The devices described herein may include one or more sensors 126, such as using multiple optical conductors, positioned to monitor a direct or indirect source of sterilization radiation.Photonic conductors useful in the context of the devices described herein include, but are not limited to, fiber optic "cables" (suitable for conducting light over long distances with low loss), or simple "light guides" formed from glass, polymers, or other simple optically transparent materials that capture and confine light within themselves and conduct light with low loss. In use, "light guides" as referred to herein are generally more suitable for conducting light over short distances to prevent undesirable losses. Lenses may be used to collect radiation and send it to a detection device, or the collected radiation can be transported elsewhere for measurement.

[0160] In some embodiments, it may be advantageous to have one sensor 126 or set of sensors 126 for detecting the global (i.e., aggregate) amount of radiation delivered to the internal volume 114, and another sensor 126 or set of sensors 126 for identifying or monitoring each disinfection area, source, or other feature within the internal volume 114.

[0161] In one embodiment, the sterilization system 100 is controlled by the controller 160 to direct operation of the radiation source 104 at a particular power level and at particular time intervals, i.e., to achieve a predetermined cumulative threshold radiation dose. For example, if UV-C radiation is used as the sterilization radiation, in a particular embodiment, the predetermined threshold dose is approximately 50,000 μJ / cm 2 ~Approx. 10,000,000μJ / cm 2 In some such embodiments, the dose may be selected from between about 50,000 μJ / cm. 2 ~Approx. 750,000μJ / cm 2 Approximately 50,000μJ / cm 2 ~Approx. 650,000μJ / cm 2 Approximately 50,000μJ / cm 2 ~Approx. 500,000μJ / cm 2 Approximately 50,000μJ / cm 2 ~Approx. 450,000μJ / cm2 Approximately 50,000μJ / cm 2 ~Approx. 350,000μJ / cm 2 Approximately 50,000μJ / cm 2 ~Approx. 250,000μJ / cm 2 Approximately 50,000μJ / cm 2 ~Approx. 100,000μJ / cm 2 or other similar values, such as about 50,000 μJ / cm 2 ~Approx. 1,000,000μJ / cm 2 In further such embodiments, the dose may be selected from between about 150,000 μJ / cm 2 ~Approx. 750,000μJ / cm 2 Approximately 150,000μJ / cm 2 ~Approx. 650,000μJ / cm 2 Approximately 150,000μJ / cm 2 ~Approx. 500,000μJ / cm 2 Approximately 150,000μJ / cm 2 ~Approx. 450,000μJ / cm 2 Approximately 150,000μJ / cm 2 ~Approx. 350,000μJ / cm 2 Approximately 150,000μJ / cm 2 ~Approx. 250,000μJ / cm 2 or other similar values. In yet other such embodiments, the dose is about 250,000 μJ / cm 2 ~Approx. 750,000μJ / cm 2 Approximately 250,000μJ / cm 2 ~Approx. 650,000μJ / cm 2 Approximately 250,000μJ / cm 2 ~Approx. 500,000μJ / cm 2 Approximately 250,000μJ / cm 2 ~Approx. 450,000μJ / cm 2 Approximately 250,000μJ / cm 2 ~Approx. 350,000μJ / cm 2 or other similar values.

[0162] Having presented several embodiments, further explanation of some of the terms used herein may be useful to facilitate a more complete understanding of what is regarded as the invention within this disclosure.

[0163] In embodiments of the present disclosure, one or more particular sterilization structures may include a controller 160 and integrated or otherwise associated electronic circuitry. Various components or devices of these embodiments are described herein interchangeably as "coupled," "connected," and "attached," etc. Materials and joints formed where two or more structures meet in this embodiment are joined to a mechanically, medically, or otherwise industry-acceptable level.

[0164] 8 includes a data flow diagram illustrating non-limiting processes that may be utilized by embodiments of the sterilization system 100 and the sterilization tray system 130. In this regard, each process described may represent a module, segment, or portion of software code that includes one or more executable instructions for performing certain logical functions. It should also be noted that in some implementations, functions described in a process may be performed in a different order, may include additional functions, may be performed simultaneously, and / or may be omitted.

[0165] The figures within this disclosure illustrate portions of one or more non-limiting computing device embodiments, such as one or more components of controller 160. These computing devices may comprise operating hardware found in conventional computing device equipment, such as one or more processors, volatile or non-volatile memory, serial and parallel input / output (I / O) circuitry conforming to various standards and protocols, wired and / or wireless network circuitry (e.g., communications transceivers), one or more user interface (UI) modules, logic circuits, and other electronic circuits.

[0166] A processing device or "processor" as described herein comprises a central processing unit (CPU), a microcontroller (MCU), a digital signal processor (DSP), an application specific integrated circuit (ASIC), a peripheral interface controller (PIC), a state machine, and the like. Thus, a processor as described herein comprises any device, system, or part thereof, that controls at least one operation, and such devices may be implemented in hardware, firmware, or software, or any combination of at least two of them. The functionality associated with any particular processor may be centralized or distributed, either locally or remotely. A processor may interchangeably refer to any type of electronic control circuitry configured to execute programmed software instructions. The programmed instructions may be high-level software instructions, compiled software instructions, assembly language software instructions, object code, binary code, or microcode, and the like. The programmed instructions may be located in an internal or external memory, or may be hard-coded as a state machine or a set of control signals. In accordance with the methods and devices referenced herein, one or more embodiments describe software executable by a processor that, when executed, performs one or more of the method operations.

[0167] This application discusses multiple embodiments that comprise or otherwise cooperate with one or more computing devices. It is recognized that these computing devices are configured to execute one or more algorithms that implement the inventive concepts taught herein. It is understood that each of said algorithms is a finite sequence of steps for solving a logical or mathematical problem or performing a task. Any or all of the algorithms taught in this disclosure may be illustrated by mathematical formulas, flow diagrams, data flow diagrams, descriptions herein, and other such means as are apparent within this disclosure. Along these lines, a structure for implementing the algorithms disclosed herein comprises at least one processing device that executes at least one software instruction retrieved from at least one memory device. These structures may optionally further comprise appropriate input circuitry known to those of ordinary skill in the art (e.g., keyboards, buttons, memory devices, communication circuits, touch screen inputs, and any other integrated circuit and peripheral circuit inputs (e.g., accelerometers, thermometers, light detection circuits, and other such sensors)), appropriate output circuitry known to those of ordinary skill in the art (e.g., displays, light sources, audio devices, tactile devices, control signals, switches, relays, etc.), and any additional circuitry or other structures taught in this disclosure. To this end, any incorporation of means-plus-function or step-plus-function elements in any claim is expressly incorporated herein as desired.

[0168] As known to those skilled in the art, a computing device has one or more memories, each memory comprising any combination of volatile and non-volatile computer readable media for reading and writing. Volatile computer readable media comprises, for example, random access memory (RAM). Non-volatile computer readable media comprises, for example, read only memory (ROM), magnetic media such as hard disks, optical disks, flash memory devices, and / or CD-ROMs, etc. In some examples, a particular memory is virtually or physically separated into separate areas such as a first memory, a second memory, a third memory, etc. In these examples, it is understood that different memory partitions may be located in different devices or embodied in a single memory. In some examples, the memory is a non-transitory computer medium configured to store software instructions configured to be executed by a processor. Some or all of the stored contents of the memory may comprise software instructions executable by a processing device to perform one or more specific operations.

[0169] The computing devices illustrated herein may further comprise operational software found in conventional computing devices, such as operating systems or task loops, and software drivers for directing operations via I / O circuitry, networking circuitry, and other peripheral component circuitry. Additionally, the computing devices may comprise operational application software, such as network software for communicating with other computing devices, database software for building and maintaining databases, task management software for appropriately distributing communication and / or operational workloads among various processors, etc. In some examples, the computing device is a single hardware machine having at least some of the hardware and software listed herein, and in other examples, the computing device is a networked collection of hardware and software machines that work together in a server farm to perform the functionality of one or more embodiments described herein. Some of the conventional hardware and software aspects of a computing device are not shown in the drawings for simplicity.

[0170] When configured as described herein, each computing device may be transformed from a general purpose and unspecified computing device into a combination device configured with hardware and software configured for a specific and specialized use, such as to provide a given practical application and technical solution. To the extent that any of the inventive concepts described herein are found by an authoritative judge to be incorporated into an abstract idea when configured as described herein, an orderly combination of elements and limitations is clearly presented to realize the desired inventive concept by translating the abstract idea into a clear and concrete practical application of the abstract idea.

[0171] Although the embodiments described herein utilize computerized technology to improve disinfection technology, other techniques and tools are still available for disinfection of target objects. Thus, the claimed subject matter does not exclude the entire or even most of the disinfection technology field. The innovations described herein utilize both new and known building blocks combined in a new and useful way with other structures and limitations to create something beyond what was previously known in the past. These embodiments improve computing systems that, if unprogrammed or otherwise programmed, cannot perform or realize the specific disinfection system features claimed in this application. The embodiments described in this disclosure improve known disinfection processes and technologies. The computerized operations described in the embodiments herein are not purely conventional and are not fully understood. Rather, these operations are new in the industry. Moreover, the combination of operations as described in combination with the present embodiment results in new information, motivation, and business results that do not yet exist when the operations are considered individually. There is no widely accepted definition of what constitutes a specific idea. To the extent that the concepts discussed in this disclosure are considered specific, the claims provide much more specific, practical, and specific applications of said purportedly specific concepts, and improve upon previously known computer-based systems for performing disinfection operations.

[0172] The software may comprise a full executable software program, a simple configuration data file, a link to additional instructions, or any combination of known software types. When a computing device updates software, the update may be small or large. For example, in some instances, a computing device downloads a small configuration data file for a portion of the software, and in other instances, a computing device completely replaces most or all of the software present on itself or another computing device with a fresh version. In some instances, the software, data, or software and data are encrypted, encoded, and / or otherwise compressed for reasons including security, privacy, data transfer speed, or data cost, etc.

[0173] The database structure, if present in the disinfection system described herein, may be formed in a single database or multiple databases. In some examples, the hardware or software storage repositories are shared among the various functions of the particular system to which they relate. The databases may be formed as part of a local system or local area network. Alternatively or additionally, the databases may be formed remotely, such as in a distributed "cloud" computing system, which is accessible via a wide area network or some other network.

[0174] The input / output (I / O) circuitry and user interface (UI) modules include serial ports, parallel ports, universal serial bus (USB) ports, IEEE 802.11 transceivers, and other transceivers compliant with protocols managed by one or more reference-setting bodies, displays, projectors, printers, keyboards, computer mice, microphones, and microelectromechanical systems (MEMS) devices such as accelerometers.

[0175] In at least one embodiment, devices such as the controller 160 may communicate with other devices by communicating over a network. The network may involve an Internet connection or some other type of local area network (LAN) or wide area network (WAN). Non-limiting examples of structures that enable or constitute part of a network include, but are not limited to, Ethernet, twisted pair Ethernet, digital subscriber line (DSL) devices, wireless LAN, Wi-Fi, or WiMax (Worldwide Interoperability for Microwave Access), etc.

[0176] In the present disclosure, the memory may be used in either configuration. The memory may be configured to store data. Alternatively or additionally, the memory may be a non-transitory computer readable medium (CRM). The CRM is configured to store computing instructions executable by the processor of the controller 160. The computing instructions may be stored individually or as groups of instructions in the form of files. The files may comprise functions, services, libraries, and the like. The files may comprise one or more computer programs or may be part of a larger computer program. Alternatively or additionally, each file may comprise data or other computer support material useful for performing the computing functions of the disinfection system.

[0177] Buttons, keyboards, computer mice, memory cards, serial ports, biosensor readers, touch screens, and the like may be individually or collectively useful to a user operating the sterilization system. For example, these devices may input control information to the system. Displays, printers, memory cards, LED indicators, temperature sensors, audio devices (e.g., speakers, piezoelectric devices, and the like), vibrators, and the like are all useful for presenting output information to a user operating the sterilization system. In some examples, the input and output devices are directly coupled to the controller 160 and electronically coupled to a processor or other operating circuitry. In other examples, the input and output devices send information via one or more communication ports (e.g., RS-232, RS-485, infrared, USB, and the like).

[0178] As described herein, for simplicity, in some examples, the user may be described in a male setting. It is understood that the user can be of any gender, and terms such as "he," "his," and the like, as used herein, should be interpreted as broadly encompassing all known gender definitions. As required by context within this disclosure, unless the context may suggest otherwise, the singular shall mean the plural and the plural shall mean the singular, and all pronouns shall mean and include the persons, entities, businesses or legal entities with which they are associated, and male shall mean female and female shall mean male.

[0179] Where a range is presented, it is understood that every intermediate value between the upper and lower limits of the range, to the tenth of the unit of the lower limit unless the context clearly indicates otherwise, and any other stated or intermediate value in the said range, is encompassed within the scope of the invention. The upper and lower limits of these smaller ranges may be independently included in the smaller ranges, subject to any specifically excluded limit in a stated range being also encompassed within the scope of the invention. Where a stated range includes one or both of its limits, ranges excluding either or both of those included limits are also included within the scope of the invention.

[0180] Unless otherwise defined, technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, and a limited number of example methods and materials are described herein.

[0181] In this disclosure, when an element (e.g., a component, circuit, device, apparatus, structure, layer, or material, etc.) is referred to as being "located on," "coupled to," or "connected to" another element, the elements can be directly "located on," "coupled to," or "connected to" each other, or there may be intervening elements. In contrast, when an element is referred to as being "directly located on," "directly coupled to," or "directly connected to" another element, there are no intervening elements present.

[0182] The terms "including" and "comprising" and their derivatives and variations are to be interpreted in an open inclusive sense without limitation in all syntactic contexts (e.g., "including but not limited to"). The term "or" is inclusive and means "and / or". The terms "associated with" and "related to" and their derivatives may be understood to mean including, contained in, interconnected, containing, contained within, connected to or connected with, coupled to or connected with, in contact with, cooperate with, interposed in, juxtaposed to, proximate to, bound to or bound by, having, or having the characteristics of, etc.

[0183] References throughout this specification to "one embodiment" and variations thereof mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the appearances of the phrase "in one embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0184] In this disclosure, terms such as first, second, etc. may be used to describe various elements, but these elements should not be limited by these terms unless the context clearly indicates that such limitation is necessary. These terms are only used to distinguish one element from another. For example, a first machine can be called a second machine, and similarly, a second machine can be called a first machine, without departing from the scope of the inventive concept.

[0185] In this disclosure, the singular forms "a," "an," and "the" include plural references unless content and context clearly dictate otherwise. The conjunctions "and" and "or" are generally used in their broadest sense to include "and / or," unless content and context clearly dictate inclusiveness or exclusivity, as the case may be. Compounds of "and" and "or," when recited herein as "and / or," include embodiments including all of the associated elements and at least one alternative including less than all of the associated elements.

[0186] In this disclosure, conjunctive enumerations use a comma, which may be known as the Oxford comma, Harvard comma, serial comma, or other similar terminology, and such enumerations are intended to join words, phrases, or sentences, and what follows the comma is further included within the enumeration.

[0187] The section headings and "Summary of the Disclosure" provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.

[0188] The disinfection system described in this disclosure provides multiple technical effects and advantages to the field of target disinfection. The target may be a medical device, such as an ultrasound probe or other imaging probe, an invasive medical procedure instrument, and a dental instrument. A non-limiting set of technical effects and advantages includes the ability to determine when the target is properly aligned and contained within a UV-transparent disinfection tray, and the ability to determine when the UV-transparent disinfection tray is properly aligned within a disinfection chamber. If the disinfection tray includes a controller, the disinfection tray controller can communicate information identifying the disinfection tray, the target, or both the disinfection tray and the target to the disinfection chamber, which information can be used to control the disinfection process.

[0189] The various embodiments described above can be combined to provide further embodiments. Various features of these embodiments are optional, and features of one embodiment may be combined as appropriate with other embodiments. Aspects of these embodiments can be modified as necessary to provide still other embodiments by using concepts of the various patents, patent applications, and patent application publications.

[0190] Example A-1 is a sterilization tray device comprising a tray portion formed from a UV-transmissive material, the tray portion having a receptacle configured therein for receiving a target object to be sterilized, the receptacle having a first defined shape and first defined dimensions, and an alignment portion having a second defined shape and second defined dimensions.

[0191] Example A-2 may comprise the subject matter of Example A-1, and alternatively or additionally, of any other example herein, wherein the receptacle is configured to receive only a portion of the target object to be disinfected.

[0192] Example A-3 may comprise the subject matter of any of Examples A-1 and A-2, and alternatively or additionally of any other examples herein, wherein the second defined shape is a cuboid, a cube, a rectangular cuboid, a rectangular parallelepiped, a convex polyhedron bounded by six quadrilateral faces, a rectangular box, or any other defined shape.

[0193] Example A-4 may comprise the subject matter of any of Examples A-1 to A-3, and alternatively or additionally any other example herein, where the target object to be disinfected is a probe, a medical / dental instrument, a cable, a handle, or any other object to be disinfected.

[0194] Example A-5 may comprise the subject matter of any of Examples A-1 through A-4, and alternatively or additionally, any other example herein, wherein the UV-transmissive material comprises at least one of plastic, glass such as quartz, gel, polymer, polymethylmethacrylate (PMMA), and polystyrene.

[0195] Example A-6 may comprise the subject matter of any of Examples A-1 through A-5, and alternatively or additionally, any other example herein, wherein the tray portion is configured for single use.

[0196] Example A-7 may comprise the subject matter of any of Examples A-1 to A-6, and alternatively or additionally any other example herein, wherein the disinfection device is a disposable device.

[0197] Example A-8 may comprise the subject matter of any of Examples A-1 through A-7, and alternatively or additionally, any other example herein, wherein the tray portion has at least fifty percent (50%) UV transmissivity.

[0198] Example A-9 may comprise the subject matter of any of Examples A-1 through A-8, and alternatively or additionally, any other example herein, wherein the tray portion has at least seventy-five percent (75%) UV transmissivity.

[0199] Example A-10 may comprise the subject matter of any of Examples A-1 through A-9, and alternatively or additionally, any other example herein, wherein the tray portion has at least ninety-five percent (95%) UV transmissivity.

[0200] Example A-11 may comprise the subject matter of any of Examples A-1 through A-10, and alternatively or additionally any other example herein, wherein the tray portion is a molded structure, a blow molded structure, a laser cut structure, or a thermoformed structure.

[0201] Example A-12 may comprise the subject matter of any of Examples A-1 through A-11, and alternatively or additionally any other example herein, and further comprises at least two handle mounting structures.

[0202] Example A-13 may comprise the subject matter of Example A-12, and alternatively or additionally, of any other example herein, further comprising at least two handles, each of the at least two handles configured to removably couple to a corresponding handle mounting structure.

[0203] Example A-14 may comprise the subject matter of any of Examples A-1 to A-13, and alternatively or additionally any other example herein, wherein the alignment portion comprises at least one alignment feature.

[0204] Example A-15 may comprise the subject matter of any of Examples A-1 to A-14, and alternatively or additionally any other example herein, wherein at least one alignment feature is an electronic alignment feature.

[0205] Example A-16 may comprise the subject matter of any of Examples A-1 to A-15, and alternatively or additionally any other examples herein, wherein the electronic alignment feature comprises at least one time-of-flight sensor or at least one photodiode.

[0206] Example A-17 may comprise the subject matter of any of Examples A-1 through A-16, and alternatively or additionally any other example herein, and further comprises a lid configured to cover at least the receptacle.

[0207] Example A-18 may comprise the subject matter of any of Examples A-1 to A-17, and alternatively or additionally any other example herein, further comprising at least one UV sensor.

[0208] Example A-19 may comprise the subject matter of any of Examples A-1 to A-18, and alternatively or additionally any other example herein, and further comprises an electronics module having a communications interface, a user interface (e.g., a voice interface, a visual interface, or a tactile user interface), at least one clean / not clean indicator (e.g., a red / green indicator), a last clean time indicator (e.g., disinfection "expired / not expired"), a closed door sensor, a serial number or other identifier, an encryption / decryption module, and an in-chamber alignment module.

[0209] Example A-20 may comprise the subject matter of any of Examples A-1 to A-19, and alternatively or additionally any other example herein, wherein the electronic device module is hermetically sealed within the tray portion.

[0210] Example A-21 may comprise the subject matter of any of Examples A-1 to A-20, and alternatively or additionally any other examples herein, wherein the electronics module is configured to communicate identification information associated with the target object to be sterilized from the sterilization device to the sterilization system.

[0211] Example A-22 may comprise the subject matter of any of Examples A-1 through A-21, and alternatively or additionally any other example herein, and further comprises a mechanically sealable case configured to hold at least one tray, the mechanically sealable case configured to store at least one target object to be sterilized.

[0212] Example B-1 is a sterilization device comprising a tray having at least one preformed compartment configured to accommodate at least a portion of a target object to be sterilized, the tray having at least one alignment structure configured to cooperate with a corresponding alignment structure inside the sterilization chamber, and the tray being at least partially formed from a UV-transparent material.

[0213] Example B-2 may comprise the subject matter of Example B-1, and alternatively or additionally, any other example herein, and further comprises a controller configured to communicate identification information to a controller associated with the sterilization chamber, the identification information being associated with at least one of the tray and the target object to be sterilized.

[0214] Example B-3 may comprise the subject matter of any of Examples B-1 to B-2, and alternatively or additionally any other example herein, wherein the controller is configured to determine whether a target object to be disinfected is properly aligned within the preformed compartment.

[0215] Example B-4 may comprise the subject matter of any of Examples B-1 to B-3, and alternatively or additionally, any other example herein, and wherein the controller is configured to determine whether the tray is properly aligned within the sterilization chamber.

[0216] Example B-5 may comprise the subject matter of any of Examples B-1 through B-4, and alternatively or additionally any other example herein, wherein the UV-transmissive material is transparent to UV-C radiation.

[0217] Example B-6 may comprise the subject matter of any of Examples B-1 through B-5, and alternatively or additionally, any other example herein, wherein the UV transmissive material has a UV transmittance of at least fifty percent (50%).

[0218] Example B-7 may comprise the subject matter of any of Examples B-1 to B-6, and alternatively or additionally any other example herein, wherein at least one alignment structure is a protrusion configured to mate with a corresponding recess within the sterilization chamber, or wherein at least one alignment structure is a recess configured to mate with a corresponding protrusion within the sterilization chamber.

[0219] Example B-8 may comprise the subject matter of any of Examples B-1 to B-7, and alternatively or additionally any other example within this specification, wherein at least one alignment structure is a first electronic alignment structure configured to mate with a corresponding second electronic alignment structure inside the sterilization chamber.

[0220] Example B-9 may comprise the subject matter of Example B-8, and alternatively or additionally, of any other example herein, wherein the first electronic alignment structure and the second electronic alignment structure comprise at least one of an optical circuit, a radio frequency (RF) circuit, an inductive circuit, or an electrically conductive circuit.

[0221] Example B-10 may comprise the subject matter of any of Examples B-1 to B-9, and alternatively or additionally any other example herein, and further comprises a case having a lid, the case configured to house the tray before and after the sterilization process.

[0222] Example C-1 is a sterilization device comprising: placing a target object to be sterilized in a tray having at least one preformed receptacle configured therein for receiving the target object, the tray being at least partially formed from a UV-transmissive material; placing the tray in a sterilization chamber, the placing of the tray comprising cooperatively aligning alignment features of the tray with corresponding alignment features of the sterilization chamber; and performing a UV-based sterilization process in the sterilization chamber.

[0223] Example C-2 may comprise the subject matter of Example C-1, and alternatively or additionally, of any other example herein, and further includes determining a misalignment condition, where the determining the misalignment condition is by electronically determining whether a target object to be sterilized is properly aligned within at least one pre-formed receptacle or by electronically determining whether a tray is properly aligned within a sterilization chamber, determining the misalignment, and providing an output indication indicative of the misalignment condition.

[0224] Example C-3 may comprise the subject matter of any of Examples C-1 to C-2, and alternatively or additionally any other examples herein, and further includes determining a misalignment condition, wherein determining the misalignment condition is by visually determining whether the target object to be sterilized is properly aligned within at least one preformed receptacle and by tactilely determining whether the tray is properly aligned within the sterilization chamber.

[0225] Example C-4 may comprise the subject matter of any of Examples C-1 to C-3, and alternatively or additionally any other example herein, and further includes communicating identification information to the sterilization chamber, the identification information representing at least one of a tray and a target object to be sterilized, and utilizing the identification information to select a UV-based sterilization process.

[0226] Example C-5 may comprise the subject matter of any of Examples C-1 through C-4, and alternatively or additionally, any other example herein, and further includes generating metadata associated with the sterilization process and communicating the metadata to a remote computing device.

[0227] Example C-6 may comprise the subject matter of Example C-5, and alternatively or additionally of any other example herein, wherein the metadata includes at least one of time information representing when the sterilization process was performed, date information representing when the sterilization process was performed, and user identification information.

[0228] Example C-7 may comprise the subject matter of Example C-5, and alternatively or additionally, of any other example herein, wherein the metadata includes date information representing when the sterilization expires.

[0229] Example C-8 may comprise the subject matter of any of Examples C-1 through C-7, and alternatively or additionally any other example herein, and further includes extending the disinfection process based on cumulative radiation information obtained from at least one radiation sensor.

[0230] Example C-9 may comprise the subject matter of any of Examples C-1 through C-8, and alternatively or additionally, of any other examples herein, and further includes individually controlling a plurality of radiation sources in the sterilization chamber based on at least one of the tray and the target object to be sterilized, where individually controlling the plurality of radiation sources includes directing a first radiation source to output radiation for a first time interval and directing a second radiation source to output radiation for a second time interval, where the first time interval is different from the second time interval.

[0231] Example C-10 may comprise the subject matter of any of Examples C-1 to C-9, and alternatively or additionally any other example herein, wherein placing the target object to be sterilized in a tray having at least one preformed receptacle includes aligning the target object to be sterilized on a surface of the tray according to a template printed on the surface of the tray.

[0232] Example C-11 may comprise the subject matter of any of Examples C-1 through C-10, and alternatively or additionally any other example herein, wherein at least one preformed receptacle comprises a plurality of clips configured to capture several portions of a target object to be disinfected.

[0233] Example C-12 may comprise the subject matter of any of Examples C-1 through C-11, and alternatively or additionally any other example herein, and further includes verifying disinfection of the target object to be disinfected after performance of at least a portion of the UV-based disinfection process.

[0234] Example C-13 may include the subject matter of example C-12, and alternatively or additionally, of any other example herein, wherein the verifying includes sensing UV radiation using at least one radiation sensor associated with the tray.

[0235] Example C-14 may comprise the subject matter of any of Examples C-1 to C-13, and alternatively or additionally any other example herein, wherein the alignment features of the tray and the corresponding alignment features of the sterilization chamber are at least partially formed by the electronic device.

[0236] Example C-15 may comprise the subject matter of example C-14, and alternatively or additionally, of any other example herein, wherein the electronic device is configured to form an optical connection, a wireless connection, an electromagnetic connection, or an inductive connection.

[0237] Example C-16 may comprise the subject matter of any of Examples C-1 through C-15, and alternatively or additionally any other example herein, further comprising removing at least one handle structure from the tray after placing the tray in the sterilization chamber.

[0238] Example D-1 is a disinfection device comprising a controller and a UV-transparent structure having a multi-compartment receptacle formed therein and shaped to align and contain a particular type of target object to be disinfected.

[0239] Example D-2 may comprise the subject matter of Example D-1, and alternatively or additionally, of any other example herein, wherein the controller is configured to communicate identification information to the sterilization chamber, the identification information representing at least one of the tray and the target object to be sterilized.

[0240] Example D-3 may comprise the subject matter of any of Examples D-1 to D-2, and alternatively or additionally any other examples herein, wherein the UV-transparent structure comprises a plurality of alignment features, each of different ones of which is configured to mate with a corresponding alignment feature in the sterilization chamber.

[0241] Example D-4 may comprise the subject matter of Example D-3, and alternatively or additionally, of any other example herein, wherein the plurality of alignment features are non-electronic physical structures.

[0242] Example D-5 may comprise the subject matter of Example D-3, and alternatively or additionally, of any other example herein, wherein the plurality of alignment features are electronic alignment features.

[0243] Example D-6 may comprise the subject matter of any of Examples D-1 to D-5, and alternatively or additionally any other examples herein, and further comprises a radiation sensor configured to provide information representative of the amount of radiation received during the sterilization process.

[0244] Example D-7 may comprise the subject matter of example D-6, and alternatively or additionally, of any other example herein, wherein the radiation sensor comprises at least one electro-optical sensor.

[0245] Example D-8 may comprise the subject matter of Example D-6, and alternatively or additionally, of any other example herein, wherein the radiation sensor includes at least one radiation-sensitive material configured to change color based on the amount of radiation received during the sterilization process.

[0246] Example D-9 may comprise the subject matter of any of Examples D-1 through D-8, and alternatively or additionally any other examples herein, wherein the multi-compartment receptacle comprises a plurality of clips appropriately positioned over the printed outline of the target object to be disinfected.

[0247] Example D-10 may comprise the subject matter of any of Examples D-1 through D-9, and alternatively or additionally any other examples herein, wherein the multi-compartment receptacle comprises a plurality of receptacle portions formed below a surface of the UV-transparent structure.

[0248] Example D-11 may comprise the subject matter of any of Examples D-1 to D-10, and alternatively or additionally any other examples herein, wherein the UV-transparent structure is a molded plastic structure.

[0249] Example D-12 may comprise the subject matter of any of Examples D-1 through D-11, and alternatively or additionally any other examples herein, wherein the UV-transmissive structure is configured for multiple disinfection cycles.

[0250] Example D-13 may comprise the subject matter of any of Examples D-1 to D-12, and alternatively or additionally any other examples herein, wherein the UV-transparent structure is a disposable structure configured for a single disinfection cycle.

[0251] Example D-14 may comprise the subject matter of any of Examples D-1 through D-13, and alternatively or additionally any other examples herein, wherein the UV-transmissive structure is configured for sealed long-term storage.

[0252] Example D-15 may comprise the subject matter of any of Examples D-1 to D-14, and alternatively or additionally any other example herein, wherein the controller is incorporated within the UV-transmissive structure.

[0253] Example E-1 is a sterilization device comprising a sterilization chamber having an internal volume, a plurality of radiation sources that output sterilizing radiation when enabled, at least one sterilization chamber alignment feature, and a sterilization chamber controller configured to perform a sterilization process by enabling the plurality of radiation sources, and a sterilization tray device having a UV-transparent tray structure having a multi-compartment receptacle shaped to align and accommodate a particular type of target object to be sterilized.

[0254] Example E-2 may comprise the subject matter of Example E-1, and alternatively or additionally, of any other example herein, wherein the sterilization device further comprises at least one sterilization tray alignment feature, the at least one sterilization chamber alignment feature configured to cooperate with the at least one sterilization chamber alignment feature when the sterilization tray device is placed within the sterilization chamber.

[0255] Example E-3 may comprise the subject matter of Example E-2, and alternatively or additionally, of any other example herein, wherein at least one sterilization tray alignment feature is a non-electronic physical structure.

[0256] Example E-4 may comprise the subject matter of Example E-3, and alternatively or additionally of any other example herein, wherein proper alignment of the sterilization tray device within the sterilization chamber is indicated by tactile feedback.

[0257] Example E-5 may comprise the subject matter of Example E-2, and alternatively or additionally, of any other example herein, wherein at least one sterilization tray alignment feature is an electronic alignment feature.

[0258] Example E-6 may comprise the subject matter of Example E-5, and alternatively or additionally, of any other example herein, wherein proper alignment or improper alignment of the sterilization tray device within the sterilization chamber is indicated by at least one of an audio output and a visual output.

[0259] Example E-7 may comprise the subject matter of any of Examples E-1 to E-6, and alternatively or additionally any other example herein, wherein the sterilization chamber is configured to hold multiple sterilization tray devices simultaneously.

[0260] Example E-8 may comprise the subject matter of any of Examples E-1 to E-7, and alternatively or additionally any other example herein, wherein the sterilization tray device is configured to simultaneously align and contain multiple targets to be sterilized.

[0261] Example E-9 may comprise the subject matter of any of Examples E-1 to E-8, and alternatively or additionally any other example herein, wherein the sterilization chamber device further comprises a door and a door sensor, and wherein the sterilization chamber controller is configured to determine when the door is closed, and wherein the sterilization chamber controller is further configured to prevent and pause the sterilization process when the door sensor indicates that the door is open.

[0262] Example E-10 may comprise the subject matter of Example E-9, and alternatively or additionally, of any other example herein, wherein the sterilization chamber device further comprises a second door and a second door sensor, and the sterilization chamber controller is configured to determine when both the door and the second door are closed, and the sterilization chamber controller is further configured to prevent and pause the sterilization process when the door sensor indicates that the door is open or when the second door sensor indicates that the second door is open.

[0263] Example E-11 may comprise the subject matter of Example E-10, and alternatively or additionally, of any other examples herein, wherein the sterilization chamber device further comprises a first door lock mechanism configured to lock and unlock the door, and a second door lock mechanism configured to lock and unlock the second door, and the sterilization chamber controller is configured to determine a pre-sterilization state, where the pre-sterilization state is a first time before the start of a sterilization process, determine a current sterilization state, where the current sterilization state is a second time when a sterilization process has been started but not completed, determine a post-sterilization state, where the post-sterilization state is a third time at the completion of a sterilization process, unlock the door during the pre-sterilization state, lock the second door during the pre-sterilization state, lock both the door and the second door during the current sterilization state, lock the door during the post-sterilization state, and unlock the second door during the post-sterilization state.

[0264] Example E-12 may comprise the subject matter of example E-11, and alternatively or additionally any other example herein, where the sterilization chamber is integrated into the wall.

[0265] Example E-13 may comprise the subject matter of Example E-12, and alternatively or additionally, of any other example herein, wherein a first side of the wall has a door, an opposing second side of the wall has a second door, the first side of the wall being a pre-disinfected side of the wall, and the opposing second side of the wall being a post-disinfected side of the wall.

[0266] Example E-14 may comprise the subject matter of any of Examples E-1 to E-3, and alternatively or additionally any other examples herein, wherein the sterilization tray device further comprises a sterilization tray controller, the sterilization tray controller configured to communicate identification information to the sterilization chamber controller, the identification information being indicative of at least one of the UV-transparent tray structure and the particular type of target object to be sterilized.

[0267] Example E-15 may comprise the subject matter of example E-14, and alternatively or additionally, of any other example herein, wherein the sterilization chamber controller is further configured to select a sterilization process from a plurality of sterilization processes based on the identification information.

[0268] Example E-16 may comprise the subject matter of example E-14, and alternatively or additionally, of any other example herein, wherein the sterilization chamber controller is further configured to control the sterilization process based on the identification information.

[0269] Example E-17 may comprise the subject matter of example E-14, and alternatively or additionally, of any other example herein, wherein the sterilization chamber controller is further configured to selectively enable a first radiation source among the plurality of radiation sources and simultaneously disable a second radiation source among the plurality of radiation sources during the sterilization process based on the identification information.

[0270] Example E-18 may comprise the subject matter of any of Examples E-1 to E-17, and alternatively or additionally any other examples within this specification, wherein the sterilization chamber controller is further configured to generate metadata based on the sterilization process and communicate at least a portion of the metadata to a remote computing device.

[0271] Example E-19 may comprise the subject matter of Example E-18, and alternatively or additionally, of any other example within this specification, wherein the metadata comprises user identification information representing the identity of the user who initiated the disinfection process.

[0272] Example E-20 may comprise the subject matter of example E-18, and alternatively or additionally, of any other example within this specification, wherein the metadata comprises timestamp information representing the date when the sterilization process was performed.

[0273] Example E-21 may comprise the subject matter of example E-18, and alternatively or additionally, of any other example herein, wherein the sterilization chamber controller is further configured to generate expiration data associated with the sterilization process.

[0274] Example E-22 may comprise the subject matter of any of Examples E-1 to E-21, and alternatively or additionally any other examples within this specification, wherein the sterilization tray device further comprises at least one electronic radiation sensor integrated into a surface of the sterilization tray device.

[0275] Example E-23 may comprise the subject matter of example E-22, and alternatively or additionally, any other example herein, wherein the sterilization chamber controller is further configured to disable the multiple radiation sources based on information from the at least one electronic radiation sensor.

[0276] Example E-24 may comprise the subject matter of any of Examples E-1 to E-24, and alternatively or additionally any other examples within this specification, wherein the sterilization tray device further comprises a first electronic radiation sensor integrated into a surface of the sterilization tray device at a first position near the first receptacle portion of the UV-transparent tray structure, and a second electronic radiation sensor integrated into a surface of the sterilization tray device at a second position near the second receptacle portion of the UV-transparent tray structure.

[0277] Example E-25 may comprise the subject matter of example E-22, and alternatively or additionally, of any other example herein, wherein the sterilization chamber controller is further configured to selectively enable and disable a first radiation source from among the multiple radiation sources based on information from the first electronic radiation sensor, and to selectively enable and disable a second radiation source from among the multiple radiation sources based on information from the second electronic radiation sensor.

[0278] Example F-1 is a non-transitory computer readable storage medium having stored thereon content for configuring a sterilization system to perform a method, the method including determining whether a target to be sterilized is properly aligned within a tray portion of a sterilization tray device, the tray portion being formed from a UV-transmissive material and having a receptacle shaped to align and receive at least a portion of the target to be sterilized, and communicating identification information associated with at least one of the tray portion and the target to be sterilized to the sterilization device.

[0279] Example F-2 may comprise the subject matter of Example F-1, and alternatively or additionally, of any other example herein, the method further including selecting a sterilization process from a plurality of available sterilization processes based on the identification information.

[0280] Example F-3 may comprise the subject matter of Example F-2, and alternatively or additionally, of any other example herein, the method further including terminating the selected sterilization process based on data from at least one radiation sensor integrated into the sterilization tray device.

[0281] Example F-4 may comprise the subject matter of Example F-2, and alternatively or additionally, of any other example within this specification, the method further including performing a selected disinfection process based on at least one alignment status indicator.

[0282] Example F-5 may comprise the subject matter of Example F-4, and alternatively or additionally, of any other example herein, wherein the alignment status indicator is generated based on proper alignment of the sterilization tray device within the sterilization device.

[0283] The various embodiments described above can be combined to provide further embodiments, and aspects of these embodiments can be modified as necessary to provide still other embodiments by employing concepts from the various patents, patent applications, and patent application publications.

[0284] For example, other UV-transparent receptacle devices may be designed such that at least a portion of the instrument to be disinfected may be placed in a position compatible with high-level disinfection.

[0285] These and other changes can be made to these embodiments in light of the above detailed description. Generally, in the appended claims, the terms used should not be construed to limit the scope of the claims to the specific embodiments disclosed in the specification and claims, but should be construed to include all possible embodiments along with the full scope of equivalents to which such claims are entitled. Thus, the claims are not limited by this disclosure.

[0286] It is understood that the configuration of the UV-transparent receptacle allows for exposure of all portions of interest of the medical instrument to be disinfected, specifically the cold junctions of the instrument, to a UV dose sufficient to achieve high-level disinfection (as defined by the Centers for Disease Control and Prevention, known as CDC) and to minimize exposure differences between different points (maximizing exposure uniformity). Furthermore, the features of the UV-transparent receptacle allow for alignment with predictions derived from the results of one or more tests and / or one or more optical simulations that determine the exposure thresholds (dose or time) required to achieve high-level disinfection of the instrument, and specifically its cold junctions, resulting from interactions between the geometry of the instrument, its positioning within the enclosure, and the features of the enclosure.

[0287] Additionally, the physical features of the sterilization system (transparency, shape, positioning) are such that a control system based on one or more optical sensors can sense changes in the optical properties of elements of the sterilization chamber (e.g., source emissivity, wall reflectivity, receptacle transmissivity) to measure one or more doses that must be above one or more system thresholds for validation of the HLD cycle. [Explanation of symbols]

[0288] 100 Disinfection System 100a First disinfection system 100b Secondary Disinfection System 100c Disinfection System 100d Disinfection System 100e Disinfection System 100f Disinfection Devices / Systems 100g Disinfection System 102 Disinfection chamber 102c Disinfection chamber 102d Disinfection chamber 102e Disinfection chamber 102f Disinfection Chamber 102g Disinfection Chamber 104 Radiation source 104a Radiation source 104b Radiation source 104c radiation source 106 Housing 108 Side wall 110 Top 112 Doors 112a Interlocking mechanism 114 Inner Volume 116 Access opening 118 reflective surfaces, internal surfaces, internal reflective surfaces 120 Target 122 Suspension Assembly 124 Alignment Features 124a Alignment feature 124b Alignment feature 126 Radiation Sensor 126a First radiation sensor 128 Probes 128a Wideband linear array ultrasonic transducer probe, medical probe 128b Intra-body ultrasound transducer probes, medical probes 128c Handheld Convex Array Ultrasound Transducer Probe, Medical Probe 130 Disinfection tray system, disinfection tray, disinfection tray part 130a Disinfection Tray System 130b Disinfection Tray System 130c Disinfection Tray System 130d Disinfection Tray System 130e Disinfection Tray System 130f Disinfection Tray System 130g Disinfection Tray System 130h Disinfection Tray System 130i Disinfection Tray System 130j Disinfection Tray System 132 Receptacle, receptacle part 132a receptacle 132b receptacle 132c receptacle 132e Receptacle 132f receptacle 132g receptacle 132h Receptacle 132i Receptacle 134 Tray part 134a Tray part 134b Tray part 134c Tray part 134d Tray part 134e Tray part 134f Tray part 134g Tray part 134h Tray part 134i Tray part 134j Tray part 136 Alignment part 136a First Receptacle 136b Alignment part 136c Secondary Receptacle 138 Receptacle, receptacle part 138a Primary receptacle part 138b Alignment receptacle part 138c Secondary Receptacle Part 140 Radiation Sensitive Media 142 Alignment receptacle penetration part 144a Holding structure 144b Holding structure 144c holding structure 144d holding structure 144e Holding Structure 144f holding structure 146 Container part, mechanically sealable case 148a Handle 148b Handle 150 Locking mechanism 152 Lid part, sealable lid 160 Electronic control module, controller 160a Controller 160b Controller 162 processors 164 Memory 166 Software Instructions, Executable Software 166a Chamber software executable instructions, chamber software 166b Tray software executable instructions, Tray software 168 Parameters 170 User Interface 172 Sensor Interface 174 Communication Interface 176a Identification Module 176b Identification Module 178a Disinfection Module 178b Sanitized Tray Module 180a Alignment module 180b Alignment module 182a Door Control Module 182b Time information module 184a Sensor Control Module 184b Sensor Control Module 186a Additional logic circuit module 186b Additional logic circuit module

Claims

1. 1. A disinfection system for a reusable medical instrument, comprising:

1. A sterilization chamber comprising: An inner volume, at least one radiation source, when enabled, that outputs UV disinfection radiation and that is adapted to emit sufficient UV disinfection radiation to perform high-level disinfection; and a sterilization chamber controller configured to perform a high-level sterilization process by enabling the at least one radiation source. a sterilization chamber having a a sterilization tray device adapted to be placed within the sterilization chamber, the sterilization tray device comprising at least one UV-transparent receptacle for receiving at least a portion of at least one instrument to be sterilized, the at least one UV-transparent receptacle configured for a particular orientation and placement of an instrument to be sterilized; Equipped with 11. A sterilization system, wherein the sterilization chamber controller is configured to enable the at least one radiation source to emit a radiation dose of between 10 millijoules per square centimeter and 10 joules per square centimeter for a period of between 10 seconds and 10 minutes.

2. 10. The sterilization system of claim 1, wherein the sterilization tray device comprises at least one alignment feature that enables alignment of the instrument to be sterilized within the at least one UV-transparent receptacle.

3. 3. The disinfection system of claim 2, wherein the at least one alignment feature is a non-electronic physical structure such as a template printed on a surface of the UV-transparent receptacle.

4. The disinfection system of claim 2 , wherein the at least one alignment feature is an electronic alignment feature.

5. 2. The sterilization system of claim 1, wherein the sterilization chamber comprises at least one sterilization chamber alignment feature, and the sterilization tray device comprises at least one second sterilization tray alignment feature, the at least one second sterilization tray alignment feature configured to cooperate with the at least one sterilization chamber alignment feature when the sterilization tray device is placed within the sterilization chamber.

6. 6. The sterilization system of claim 5, wherein the at least one second sterilization tray alignment feature and / or the at least one sterilization chamber are non-electronic physical structures.

7. 10. The sterilization system of claim 1, wherein the sterilization tray device further comprises a sterilization controller configured to communicate identification information to the sterilization chamber controller, the identification information representing at least one of the UV transmissive receptacle and a particular type of instrument to be sterilized.

8. 8. The sterilization system of claim 7, wherein the sterilization chamber controller is further configured to select a sterilization process from a plurality of sterilization processes based on the identification information.

9. 8. The sterilization system of claim 7, wherein the sterilization chamber controller is further configured to control a sterilization process based on the identification information.

10. 10. The sterilization system of claim 1, wherein the sterilization tray device further comprises at least one electronic radiation sensor integrated into a surface of the sterilization tray device.

11. 11. The sterilization system of claim 10, wherein the sterilization chamber controller is further configured to disable the at least one radiation source based on information from the at least one electronic radiation sensor.

12. The sterilization tray device comprises: a first electronic radiation sensor integrated into a surface of the sterilization tray device at a first location proximate a first receptacle portion of the UV transmissive receptacle; a second electronic radiation sensor integrated into the surface of the sterilization tray device at a second location proximate a second receptacle portion of the UV transmissive receptacle; and 10. The disinfection system of claim 1, further comprising:

13. The sterilization chamber includes a plurality of radiation sources, and the sterilization chamber controller further comprises: selectively enabling and disabling a first radiation source of the plurality of radiation sources based on information from the first electronic radiation sensor; Selectively enabling and disabling a second radiation source among the plurality of radiation sources based on information from the second electronic radiation sensor. The disinfection system of claim 12, further configured to:

14. 10. The sterilization system of claim 1, comprising an element adapted to verify at least one of proper alignment of the sterilization tray device within the sterilization chamber and proper alignment of the instrument to be sterilized within the UV-transparent receptacle, the element adapted to analyze data from a sensor.

15. 2. The sterilization system of claim 1, wherein the sterilization chamber controller is configured to form multiple sterilization zones within the interior volume, and wherein the sterilization chamber controller is configured to enable the at least one radiation source to irradiate the sterilization zones with different radiation intensities, wherein at least one zone is irradiated with twice or three times the radiation intensity of another zone.

16. 10. The sterilization system of claim 1, wherein the UV-transparent receptacle is configured such that the instruments to be sterilized are oriented substantially horizontally within the sterilization chamber when the sterilization tray device is positioned within the sterilization chamber.

17. 10. The disinfection system of claim 1, wherein the instruments to be disinfected are folded or wrapped into the UV-transparent receptacle according to a predetermined path, thereby enabling high-level disinfection to be achieved by a precise optical path of UV photons.

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