Modeling to assist with high-level UV-C disinfection

Abstract

To provide a device, a system and a method to effectively control a disinfection irradiation amount of ultraviolet rays so that the lowest radiation exposure onto each surface to be disinfected.SOLUTION: A radiation source is arranged and configured to emit disinfecting radiation into an interior volume when in operation. A disinfection program in a disinfection chamber is arranged and configured to control the radiation source to emit the disinfecting radiation according to parameters determined based on at least one of a three dimensional model of the disinfection chamber and a three dimensional model of a target article to be disinfected. The three dimensional model of the disinfection chamber is formed using data collected by operating at least one radiation source in a data collection disinfection chamber, or by providing a disinfection chamber model having a virtual interior volume. The three dimensional model of the target article to be disinfected is formed by providing a target article model having a virtual surface.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure is generally directed to devices and systems for disinfecting target articles. More particularly, but not exclusively, the present disclosure relates to methods, devices, and systems for modeling various portions of a disinfection chamber and a target article to assist in high-level UV-C disinfection of the modeled target article. [Background technology]

[0002] Proper disinfection or sterilization of reusable medical devices is important in preventing person-to-person transmission of pathogenic microorganisms. The level of sterilization and disinfection applied to medical devices depends on how the device is classified. The Centers for Disease Control and Prevention (CDC) classifies medical devices as critical, semi-critical, or non-critical items depending on the intended use of the device (CDC Guidelines for Disinfection and Sterilization in Healthcare Facilities 2008). The CDC guidelines state that critical items are those that pose a high risk of infection if contaminated with any microorganism.

[0003] Examples of critical items are devices that contact sterile tissue, including surgical instruments, implants, and ultrasound probes used within sterile body cavities. These devices must be sterilized before use. Semi-critical items typically come into contact with mucous membranes or intact skin. Examples of semi-critical items include devices such as probes used for vaginal, rectal, and urinary examinations, respiratory therapy and anesthesia equipment, and some endoscopes. These medical devices should be free of all microorganisms, although reasonably low levels of bacterial spores are considered acceptable. Semi-critical items require at least high-level disinfection (HLD).

[0004] Non-critical items are items that contact non-mucosal surfaces of intact skin (e.g., blood pressure cuffs and stethoscopes). In contrast to critical and some semi-critical items, most non-critical reusable items are decontaminated at the point of use and may achieve medium- or low-level disinfection; these items typically do not need to be transported to a central processing area for servicing.

[0005] Because critical items pose a high risk of infection when contaminated with any microorganism, they typically undergo sterilization to kill and eliminate all microorganisms. Similarly, semi-critical items require high-level disinfection (HLD), in which pathogen population levels are reduced to very low levels before or between uses. Some common methods for achieving sterilization or high-level disinfection include treatment with steam and / or chemical disinfectants. Chemical treatment is often used when the items to be treated are heat-sensitive. Suitable chemical disinfectants for use in sterilizing or disinfecting medical devices include, for example, glutaraldehyde, hydrogen peroxide, orthophthalaldehyde, and peracetic acid mixed with hydrogen peroxide. Currently, some common methods for achieving high-level disinfection of semi-critical medical devices involve immersing the devices in a chemical bath. Chemical bathing for semi-critical items can involve immersion for a shorter period of time than would be required to ensure complete sterilization.

[0006] Although effective, sterilization and disinfection processes utilizing steam or chemical treatments have disadvantages. For example, the high temperatures associated with autoclaving can damage instruments being sterilized. Additionally, the chemicals used in chemical sterilization or disinfection are often costly to store and dispose of properly, and their toxicity can be dangerous to personnel. Furthermore, chemical methods and high-heat (i.e., intense heating to high temperatures in steam) systems can cause degradation of materials used in the manufacture of the medical devices being treated. Steam or chemical treatments are also time-consuming, involving several steps that can take 15 to 40 minutes to complete. These steps typically require the instrument or device to be removed to a central location and then returned to the clinical site for processing. Such delays can render the medical device unusable, which can be a serious problem when the device is used in an emergency department. These and other factors can lead to violations of sterilization or disinfection procedures recommended by the U.S. Food and Drug Administration.

[0007] Several companies offer devices and systems that can achieve high-level disinfection of reusable target items at low temperatures within a short period of time, performed locally within the clinical setting. For example, Patent Document 1 provides a disinfection method and system that uses a disinfection chamber with a radiation source, achieving high-level disinfection within 10 minutes (i.e., within 600 seconds). The temperature within the disinfection chamber is maintained at a low level. One or both of the ambient temperature within the disinfection chamber and the surface temperature of the target items to be disinfected are monitored, and a threshold temperature, for example, a temperature between 35°C and 55°C, is met and not exceeded. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Patent No. 9,364,573 Summary of the Invention [Problem to be solved by the invention]

[0009] Embodiments of devices, systems, and methods are provided for effectively controlling the disinfecting dose of ultraviolet light provided within a sterilization chamber to achieve the lowest radiation dose (i.e., lowest exposure) at target articles on each surface portion targeted for sterilization. The solution determines a model of the sterilization chamber and a model of the radiation intensity produced within the sterilization chamber. The solution also determines a model of the target object to be sterilized and a model of the radiation intensity produced within the sterilization chamber when the target object is present. In some cases, the radiation intensity model (i.e., a radiation intensity map of the sterilization chamber) is formed or otherwise supplemented by actual radiation intensity measurement data collected by sensors within the actual and operating sterilization chamber. The solution then calculates parameters necessary to deliver the lowest dose of radiation to surfaces and locations of interest on a modeled target article within the modeled sterilization chamber. The calculated parameters are used to generate a sterilization program for the modeled type of sterilization chamber. The generated sterilization program is then executed when a target article of the modeled type is placed within the modeled type of sterilization chamber.

[0010] In at least some cases, variables related to the modeling and variables related to the calculated radiation dose are considered based on collected or determined data. The data may include any one or more of empirical data, real-time data, assumed data, and the like. These variables (e.g., parameters) may be used to adjust (e.g., increase or decrease) the time of radiation delivery, adjust (e.g., increase or decrease) the intensity of radiation, adjust the radiation delivery pattern, or otherwise adjust other parameters.

[0011] In some cases, specific modeled configurations of the sterilization chamber, the target articles, or both the sterilization chamber and the target articles are specifically identified. These specific modeled configurations include configurations that are expected to receive radiation doses of interest that are higher (e.g., hot spots) or lower (e.g., cold spots) in specific areas of interest relative to the overall average radiation dose. One or more calculations are performed to adjust the parameters for delivering radiation into the sterilization chamber so that all configurations targeted for sterilization receive at least the minimum dose of radiation determined to sterilize to a given level. [Means for solving the problem]

[0012] In some embodiments, accurate confirmation of an acceptable range of delivered radiation doses is achieved. One method for confirming that the desired sterilizing radiation is present in the sterilization chamber includes collecting data (e.g., radiation intensity, radiation duration, temperature) from sensors within the chamber or otherwise associated with the chamber. In some cases, the sensors, or the collected sensor data, may be calibrated, corrected, or otherwise adjusted based on modeled radiation intensities (i.e., radiation intensity maps). In at least one exemplary embodiment, delivery of an acceptable radiation dose is based on a determination that at least some of the sensor data exceeds a particular threshold.

[0013] The application of one or more of the techniques and apparatus described herein improves the utilization rate of sterilized medical devices and also ensures that sterilization operations are not unnecessarily prolonged, avoiding unnecessary risk of damage to medical devices caused by unnecessary overexposure to sterilizing radiation. Furthermore, these techniques and apparatus provide a means for defining a minimum dose of radiation for any target object. That is, when the sterilization chamber and target medical devices, alone or in combination, can be optically simulated (i.e., modeled), a minimum dose of sterilizing radiation can be determined, and an effective sterilization chamber program can be generated without requiring tedious and difficult-to-achieve power mapping measurements of the sterilizing radiation incident on a given surface or configuration.

[0014] The method may be summarized as including: providing a sterilization chamber having an interior volume and a radiation source coupled to the interior volume, the radiation source configured to emit sterilizing radiation into the interior volume when operated; and providing a sterilization program to the sterilization chamber, the sterilization program configured to control the radiation source to emit sterilizing radiation according to parameters determined based on a three-dimensional model of the sterilization chamber and a three-dimensional model of a target article to be sterilized.

[0015] The method may further include forming a three-dimensional model of the sterilization chamber by operating at least one radiation source within the data collection sterilization chamber, collecting radiation data using at least one radiation sensor, and generating a radiation intensity map from the collected radiation data representing a plurality of radiation intensity values ​​within a plurality of regions of the data collection sterilization chamber.

[0016] The method may further include forming a three-dimensional model of the sterilization chamber by providing an initial sterilization chamber model having a virtual interior volume, arranging a plurality of virtual polygons to create a mathematical mapping of the virtual interior volume, generating simulated radiation information based on the mathematical mapping of the virtual interior volume using a ray tracing program, and generating a radiation intensity map from the simulated radiation information representing a plurality of radiation intensity values ​​within a plurality of regions of the data collection sterilization chamber.

[0017] The method may further include forming a three-dimensional model of the target item to be disinfected by providing an initial target item model having a virtual surface, arranging a plurality of virtual polygons to create a mathematical mapping of the virtual surface, and identifying at least one spot on the virtual surface of non-uniform illumination.

[0018] The method may further include forming the sterilization program by calculating a minimum dose of radiation to administer to the target article to be sterilized, where calculating the minimum dose includes information related to at least one identified cold spot; applying data from the radiation intensity map to a three-dimensional model of the target article to be sterilized based on the minimum dose; and creating parameters to control the radiation source to deliver the minimum dose of radiation.

[0019] The sterilization program may further be based on a radiation intensity map, the radiation intensity map being based on at least one radiation emission characteristic of the radiation source.

[0020] The method may further include positioning a calibration object within the internal volume, operating a radiation source with the calibration object within the internal volume, measuring radiation intensity values ​​on a portion of the calibration object while the radiation source is operating, and updating the radiation intensity map based on the measured radiation intensity values.

[0021] The sterilization program may further be based on a radiation intensity map, the radiation intensity map having multiple radiation intensity values ​​for the same spot within the internal volume, each of the multiple radiation intensity values ​​being associated with a time factor for operating the radiation source.

[0022] The time factor may include the aging of the radiation source.The time factor may include the time course of operating the radiation source.

[0023] The sterilization system may be summarized as comprising a sterilization chamber having an interior volume, a radiation source coupled to the interior volume, the radiation source emitting sterilizing radiation into the interior volume when operating, and a control system configured to control the radiation source to emit the sterilizing radiation according to parameters determined based on a three-dimensional model of the sterilization chamber and a three-dimensional model of a target item to be sterilized.

[0024] The three-dimensional model of the sterilization chamber may be associated with a radiation intensity map created using radiation data collected by at least one radiation sensor or simulated radiation information based on mathematical mapping of the interior volume.

[0025] The sterilization system may further comprise at least one radiation sensor configured to measure radiation emitted within the interior volume, and the control system may be further configured to control the radiation source based on the measured radiation and based on a calculated minimum dose of radiation to administer to the target article to be sterilized.

[0026] The calculated minimum dose may be based on a ratio of the radiation delivered to the at least one radiation sensor to the radiation delivered to a cold spot of the target item to be sterilized. The calculated minimum dose may also be based on a safety factor.

[0027] The sterilization system may further comprise a storage unit that stores an internal volumetric patterning unit configured to generate a three-dimensional model of the sterilization chamber.

[0028] The sterilization system may further comprise a storage unit that stores a target article patterning unit configured to generate a three-dimensional model of a target article to be sterilized.

[0029] A non-transitory computer-readable storage medium may be summarized as containing executable instructions that, when executed by a processor, configure the processor to operate a sterilization system according to a method, the method including the acts of providing a sterilization chamber having an internal volume and a radiation source coupled to the internal volume, the radiation source configured to emit sterilizing radiation into the internal volume when operated; and providing a sterilization program to the sterilization chamber, the sterilization program configured to control the radiation source to emit the sterilizing radiation according to parameters determined based on a three-dimensional model of the sterilization chamber and a three-dimensional model of a target article to be sterilized.

[0030] The executable instructions, which when executed by a processor, may further configure the processor to operate the sterilization system according to the method, the method may further include acts of forming a three-dimensional model of the sterilization chamber by operating at least one radiation source within the data collection sterilization chamber, collecting radiation data with at least one radiation sensor, and generating from the collected radiation data a radiation intensity map representing a plurality of radiation intensity values ​​within a plurality of regions of the data collection sterilization chamber.The executable instructions, which when executed by a processor may further configure the processor to operate the sterilization system according to the method, may further include acts of forming the three-dimensional model of the sterilization chamber by providing an initial sterilization chamber model having a virtual interior volume, arranging a plurality of virtual polygons to create a mathematical mapping of the virtual interior volume, generating simulated radiation information based on the mathematical mapping of the virtual interior volume using a ray tracing program, and generating from the simulated radiation information a radiation intensity map representing a plurality of radiation intensity values ​​within a plurality of regions of the data collection sterilization chamber. In executable instructions that, when executed by a processor, may further configure the processor to operate the sterilization system in accordance with this method, the method may further include the acts of forming a three-dimensional model of the target article to be sterilized by providing an initial target article model having a virtual surface, arranging and configuring a plurality of virtual polygons to create a mathematical mapping of the virtual surface, and identifying at least one spot on the virtual surface of non-uniform illumination.In executable instructions that, when executed by a processor, further configure the processor to operate the sterilization system according to this method, the method further includes acts of forming the sterilization program by calculating a minimum dose of radiation to administer to the target article to be sterilized, where calculating the minimum dose includes information related to at least one identified cold spot; applying data from the radiation intensity map to a three-dimensional model of the target article to be sterilized based on the minimum dose; and creating parameters to control the radiation source to deliver the minimum dose of radiation.

[0031] This Summary is provided to introduce some concepts in a simplified form that are further described in detail in the Detailed Description. Unless otherwise specified, this Summary does not identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter.

[0032] Non-limiting and non-exhaustive embodiments are described with reference to the following drawings, in which like labels refer to like parts throughout the various views unless otherwise specified. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements have been selected, enlarged, and positioned to improve readability of the drawings. The particular shapes of the elements as depicted have been selected for ease of recognition in the drawings. One or more embodiments are described hereinafter with reference to the accompanying drawings. [Brief explanation of the drawings]

[0033] [Figure 1] FIG. 1 illustrates an exemplary disinfection device embodiment. [Figure 2A] FIG. 1 illustrates an exemplary sterilization chamber, which may be referred to as an exemplary system. [Figure 2B]2A-2B are diagrams illustrating an exemplary sterilization chamber, which may be referred to as an exemplary system (FIGS. 2A-2B may be collectively referred to herein as FIG. 2). [Figure 3] FIG. 1 is a diagram of an exemplary kill curve. [Figure 4] FIG. 2 illustrates details of an exemplary controller. [Figure 5A] FIG. 2C is a view of the disinfection chamber taken along the line in FIG. 2B. [Figure 5B] FIG. 2C is a view of the disinfection chamber taken along the line in FIG. 2B. [Figure 5C] FIG. 2C is a view of the disinfection chamber taken along the line in FIG. 2B. [Figure 5D] FIG. 2C is a view of the disinfection chamber taken along the line in FIG. 2B. [Figure 5E] FIG. 2C is a view of the disinfection chamber taken along the line in FIG. 2B. [Figure 6A] FIG. 1 is a diagram of an early model of a disinfection system. [Figure 6B] FIG. 1 illustrates one method of creating a sterilization chamber model. [Figure 6C] 6A-6C are diagrams illustrating one method of forming a target article model (FIGS. 6A-6C may be collectively referred to herein as FIG. 6). [Figure 7A] FIG. 10 shows a representation of radiation emitted from a virtual radiation source into a virtual interior volume of a disinfection chamber model. [Figure 7B] FIG. 10 illustrates a modeled representation of radiation vectors formed within a virtual interior volume of a sterilization chamber model. [Figure 7C] FIG. 10 illustrates another modeled representation of radiation vectors formed within the virtual interior volume of the sterilization chamber model. [Figure 7D] FIG. 10 illustrates a modeled representation of radiation vectors formed within a virtual interior volume of a sterilization chamber model when a target article model of a target article calibration device is present. [Figure 7E]FIG. 10 illustrates a modeled representation of radiation vectors formed within a virtual interior volume of a sterilization chamber model when a target article model of a target article calibration device is present. [Figure 7F] FIG. 5F shows a modeled representation of the disinfection chamber model along the line of FIG. 5E. [Figure 7G] 7A-7G illustrate various exemplary models of radiation vectors formed within a sterilization chamber model when a particular target article model is present (FIGS. 7A-7G may be collectively referred to herein as FIG. 7). [Figure 8] FIG. 2 shows a target article model in more detail. [Figure 9A] FIG. 1 is a data flow diagram illustrating a minimum dose determination procedure. [Figure 9B] FIG. 1 is a data flow diagram illustrating a minimum dose determination procedure. [Figure 9C] FIG. 1 is a data flow diagram illustrating a minimum dose determination procedure. [Figure 9D] FIG. 9 is a data flow diagram illustrating a minimum dose determination procedure (FIGS. 9A through 9D may be collectively referred to herein as FIG. 9). [Figure 10A] FIG. 10 is a data flow diagram illustrating the use of calculated minimum dose in some embodiments of modeled and actual devices. [Figure 10B] FIG. 10 is a data flow diagram illustrating the use of calculated minimum dose in some embodiments of modeled and actual devices. [Figure 10C] FIG. 10 is a data flow diagram illustrating the use of calculated minimum dose in some embodiments of modeled and actual devices. [Figure 11] FIG. 1 illustrates a first exemplary process for determining disinfection exposure. [Figure 12] FIG. 10 illustrates exemplary details of a first partial operation for calibrating a radiation intensity map. DETAILED DESCRIPTION OF THE INVENTION

[0034] I. Overview In the following description, several specific details are set forth to provide a thorough understanding of various disclosed embodiments. However, those skilled in the art will understand 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, including client and server computing systems, as well as networks, have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

[0035] The present invention may be more readily understood by reference to this detailed description of the invention. The terms used herein are for the purpose of describing particular embodiments only and do not constitute limitations on the claims unless a court of competent jurisdiction or authorized agency of competent jurisdiction determines that such terms are limiting. Unless otherwise defined herein, terms used herein are to be given their conventional meanings as known in the relevant art.

[0036] However, before describing the embodiments, it may be helpful to first set forth definitions of some terms that will be used hereinafter.

[0037] The terms "minimum dose," "minimum radiation dose," "minimum dose of radiation," and similar terms are used throughout this specification and claims in all their grammatical forms to refer to the amount of radiation (e.g., radiation field strength, disinfecting exposure, or the like) delivered into a chamber sufficient to reduce the population of undesirable biological pathogens (organisms, cells, spores, bacteria, or the like) by a determined acceptable amount. The minimum dose may be determined and delivered using any appropriate mechanism or method. The minimum dose of radiation (i.e., disinfecting exposure) to which a designated surface or location is exposed will result in at least the desired level of disinfecting action, which may be through sterilization, killing, or other neutralization of target pathogens present on the designated surface or location. In this application, minimum dose of radiation encompasses factors such as, but not limited to, the angle of incidence of the incident radiation with respect to the affected surface, absorptivity, reflectivity, and properties of the pathogen itself that may affect the amount of emitted photons that exert a disinfecting action on the targeted pathogen, whether or not such factors are explicitly described. Thus, the minimum dose may be understood as the total dose of radiation delivered into the chamber or otherwise imposed on the target surface. In particular, without limiting the above, the minimum dose refers to the number or volume of kill units. The number or volume of kill units represents the amount of radiant energy (e.g., fluence) passing through a given element area or volume in all directions. The amount of energy may be measured, for example, in joules (J), joules per square centimeter (J / cm2), joules per second (watts), or other suitable units of measurement.

[0038] The term "low temperature" is used to mean below about 55° C. For example, in some cases of the systems, devices, and methods described herein, it is desirable to maintain the sterilization chamber, and / or target objects therein, below one or more threshold temperatures, such as a preferred low temperature of below about 35° C. and an acceptable low temperature of below about 55° C.

[0039] Devices and systems are described that effectively control the disinfecting exposure of radiation provided (e.g., generated, delivered, irradiated, or similarly operated) within a sterilization chamber, such that a selected or otherwise desired minimum exposure (i.e., minimum dose) of radiation is delivered to target articles at each surface portion desired to be disinfected.

[0040] One or more computer simulation models of the target object and the sterilization chamber are generated (i.e., a three-dimensional model of the target object, a three-dimensional model of the sterilization chamber). These models may optionally include information that accounts for hanger systems, calibration fixtures, sensors, foreign objects, and the like. One or more models of the radiation intensity within the sterilization chamber (the amount of radiation energy received by a given element area or volume in a determined configuration per unit time) are also generated based on the structural configuration of the sterilization chamber, which may include optional structures (e.g., hanger systems, fixtures, sensors, etc.), and the radiation emission characteristics of a particular radiation source configured to radiate energy into the sterilization chamber. In this manner, the optical properties of the target article to be sterilized and the chamber itself (e.g., reflection, diffusion, absorption, and such properties of radiated light) are taken into account in generating the radiation model. For example, in some embodiments, the surface structural configuration of the target article and the surface material of the target article are determined and modeled in determining the radiation intensity model within the interior volume of the sterilization chamber.

[0041] Radiation intensity models (e.g., radiation intensity maps) may predict or otherwise simulate radiation intensities at any number of locations within the interior volume of a sterilization chamber. These maps may be discrete, computer-derived simulations of adjacent / continuous naturally occurring distributions. The discrete nature is sufficient to accurately approximate the actual continuous distribution of intensities when selected to be sufficiently finely resolved. Some radiation intensity maps simulate / predict radiation intensities in an empty chamber, and some radiation intensity maps simulate / predict radiation intensities in an occupied chamber. Radiation intensity maps associated with occupied chambers may represent radiation intensities when the sterilization chamber is occupied by a medical device (e.g., one or more medical probes of any type). Other radiation intensity maps associated with occupied chambers may reflect radiation intensities when the sterilization chamber is occupied by a foreign object, such as a medical glove or writing implement inadvertently left in the chamber, a specific device for positioning or orienting a target object, or the like. In some cases, radiation intensities within a given sterilization chamber are confirmed by actual radiation intensity measurements, which provide a map of radiation intensities within the interior volume of the sterilization chamber.

[0042] In some cases, one or more initially determined radiation intensity maps may be adjusted based on a calibration target positioned within the sterilization chamber. For example, the actual radiation field intensities present in various portions of the calibration target may be detected and measured by one or more sensors attached to one or more surfaces of the calibration target and, additionally or alternatively, by one or more sensors attached to the interior volume of the sterilization chamber. The detected radiation intensity measurement data is compared to simulation data resulting from one or more selected radiation intensity models to calibrate or otherwise adjust a particular radiation intensity map. The adjustment may include updating the initial radiation map / model by at least one of local adjustment of radiation intensity values ​​on a portion of the sterilization area map or global updating of the algorithm that generates the calculated radiation intensity values ​​in the radiation map / model. The updated radiation map may then be used to determine one or more radiation doses to administer to sterilize surfaces of target articles within the sterilization chamber.

[0043] In some cases, it may be desirable to apply at least a minimum dose of sterilizing radiation to all potentially contaminated and exposed surfaces of the target article intended for sterilization to provide sufficient confidence that the desired level of sterilization will be achieved. A sterilization operation is performed to achieve the determined target sterilization exposure. The sterilization operation is directed by a processor associated with the sterilization chamber executing a program generated at least in part from a model of the sterilization chamber, a model of the target medical device, and one or more radiation intensity maps. The sterilization operation is monitored by sensors mounted in the sterilization chamber, and monitoring data (e.g., temperature data, radiation intensity data, time data) is further used to control the sterilization operation. Using these procedural techniques, the sterilization operation achieves the desired level of sterilization of all surfaces targeted for sterilization and does not unnecessarily prolong the sterilization operation. In this way, sterilization system utilization is improved by shortening the sterilization process as much as reasonably possible, further avoiding unnecessary risk of damage to sterilized medical equipment induced by excessive radiation exposure.

[0044] In the embodiments described herein, the determined minimum dose maintains the temperature within the sterilization chamber at an appropriately low level. One advantage of maintaining the temperature within the sterilization chamber at a low level is that damage to medical devices is reduced by avoiding prolonged exposure to sterilizing radiation. It is known that in the presence of intense radiation exposure, elevated temperatures can accelerate adverse effects such as aging, crazing, cracking, hardening, softening, oxidation, or some other form of chemical or physical change, including discoloration, of materials including target articles. Therefore, another advantage of maintaining the internal volume of the sterilization chamber at a low temperature is to avoid or reduce such discoloration and aging. In some cases, for example, a generated program for the sterilization chamber may provide for providing a minimum dose of radiation and monitoring the temperature within the sterilization chamber to not exceed 35°C to 55°C.

[0045] Although not limited to application to critical and semi-critical medical devices, the disclosed methods, devices, and systems are particularly suitable for high-level disinfection of reusable medical devices and instruments, including, for example, ultrasound, endotracheal, and other intracavity probes. In particular, the devices and systems described herein utilize ultraviolet ("UV") radiation to rapidly accomplish high-level disinfection without producing unacceptably high temperatures on and within the treated items. Many medical instruments are constructed from polymeric materials, and heating polymers is known to accelerate potential damage or degradation that may result from exposure to radiation during the disinfection process. Application of the systems and methods disclosed herein reduces the likelihood of such damage or degradation.

[0046] In at least some cases, the sterilization chamber is further configured to reduce damage to the sterilization target object by pretreating the chamber prior to radiation sterilization. For example, it is known that oxygen can have an adverse effect on polymer-based materials. Pretreatment may include, for example, purging oxygen from the sterilization chamber by flushing the chamber with nitrogen, filling the chamber with a neutral (e.g., inert) gas such as argon, or performing one or more other pretreatment operations.

[0047] The sterilization chamber of the present disclosure may include a housing with multiple sidewalls, a top, and a door providing access to the sterilization chamber. The sterilization chamber itself may include at least one wall defining an interior volume; in some embodiments, the sterilization chamber includes multiple sidewalls, a base, and a top with an open center. When the method and device utilize UV ​​radiation, the sterilization chamber may include one or more reflective interior surfaces, one or more UV radiation sources ("radiation sources"), such as one or more sources of UV-A, UV-B, or UV-C radiation, and one or more radiation sensors. Reflective materials suitable for use in sterilization chambers as described herein include, for example, aluminum Grand Brilliant by ALMECO GROUP, polytetrafluoroethylene (PTFE), polyvinyl alcohol (PVA), barium sulfate-containing paint, or combinations thereof. Other materials may also be employed, such as the reflective materials disclosed in U.S. Patent No. 3,956,201 at column 2, lines 56-61, and in the examples at column 7, lines 50-12, line 2, and elsewhere, and in U.S. Patent No. 3,764,364 at column 2, lines 70-3, line 20, and elsewhere, the contents of which are incorporated herein by reference. To facilitate the placement and sterilization of items to be processed within the sterilization chamber, the chamber may also include a suspension assembly for suspending, housing, or otherwise maintaining the items to be sterilized in a desired position within the sterilization chamber.

[0048] The sterilization chamber has a size and configuration that helps achieve sterilization of articles placed therein within a desired, and possibly selectable, period of time so that the surfaces of the articles are exposed to a desired level of radiation, referred to herein as a "dose." As will be understood, the level of radiation exposure (i.e., "dose") relates to both radiation intensity and exposure duration. For example, the target articles to be sterilized, the UV radiation source, and / or the UV radiation sensor may be positioned (e.g., introduced, clamped, suspended, or positioned) within the sterilization chamber in a stationary or non-stationary arrangement that improves the exposure of the articles to radiation through controlled transmission of radiation from the source. That is, any one or more of the radiation sources, including one or more of the target articles, hangers or other target article positioning devices, sensors, direct sources of UV radiation, and indirect sources of UV radiation (e.g., dedicated reflectors of radiation), may be non-stationary during a sterilization cycle. In such embodiments, the sterilization chamber is configured and operated such that one or more of the items, the UV direct light source, and / or the UV indirect light source are moved (e.g., rotated in one or more planes, raised and lowered, and the like) within the sterilization chamber in a sterilization cycle to adequately expose each surface portion of the items to a selected disinfection level of UV radiation, i.e., a minimum dose.

[0049] In at least some cases, determining whether a minimum dose of radiation has been delivered is facilitated by radiation sampled within the chamber during the sterilization process. Radiation may be directly collected / sampled or indirectly sampled after being conveyed to a detector or array of detectors by various means. One or more detectors may be located within or outside the sterilization chamber. Mirrors or other reflective surfaces, lenses, light pipes, fiber optic cables, or any other optical system may be used to facilitate delivery of a representative radiation "signal" from within the chamber to one or more sensors. Radiation collection may be narrow, medium, or wide, preferably depending on the incoming angle of incidence of the collected radiation. Because the detector may emulate the exposed surface of the target object, it may be advantageous to use a detector with a very wide acceptance angle to collect (e.g., sample) the incoming radiation. In other cases, it may be preferable to attempt to sample radiation from all incoming directions using an integrating sphere or other collector with similar functionality. In other cases, it may be preferable to limit the angle of incidence to incoming radiation traveling toward the detector within a narrow range of angles of incidence.

[0050] Other factors may also be optionally considered when determining the minimum dose for a particular target object. Some of these optional factors, which may be described in more detail, include the number of UV radiation sources and their associated radiation emission characteristics (e.g., input power, instantaneous and over time output intensity of UV radiation, aging of the radiation source, and the like). Still other optional factors that may be considered are the inclusion or selection of materials used to create one or more reflective surfaces, the size and shape of the sterilization chamber, the size and shape of the target articles, the orientation and positioning of the target articles, whether the target articles or any structures within the sterilization chamber can move during the sterilization protocol, and any other such factors.

[0051] In this description, the term "radiation source" is used generically to refer to any radiation source, including direct and / or indirect radiation sources, configured in association with a sterilization chamber. Determination of sterilization exposure may consider the exposure of the target article to all radiation sources. For example, aging of the radiation source, fluctuations in radiation output intensity, characteristic frequency / wavelength range of radiation emission, and time-dependent changes in radiation output may all be characterized for the radiation source and factored into determining sterilization exposure.

[0052] The structural configuration and radiation optical properties of the interior volume of the sterilization chamber are also identified and factored into determining the radiation dose. In one example, the structural configuration of the interior volume is identified with respect to a target article positioned within the interior volume and a radiation source coupled to emit radiation within the interior volume. For example, the structural configuration of the interior volume and the positioning of the target article affect the angle at which radiation reaches a portion of the target article directly and / or indirectly, which in turn affects the radiation intensity at the portion of the target article.

[0053] To facilitate positioning of target articles to be processed within the sterilization chamber, the sterilization chamber may also include a mounting mechanism, such as a suspension assembly, for suspending, housing, or otherwise maintaining the target articles to be sterilized in a selected position, alignment, and / or orientation, either stationary or non-stationary, within the interior volume of the sterilization chamber. Any suitable configuration for such an assembly may be utilized. For example, the assembly may be configured to suspend the articles under the influence of gravity from a central portion of the top of the sterilization chamber. In other variations, a mounting mechanism may be provided that detachably couples the articles to an assembly or wall within the sterilization chamber and / or positions and orients the articles within the sterilization chamber. The mounting system may be applied to or interact with an area on the target article that is not intended for sterilization. For example, on the cable of a probe attached to an imaging system, or on an area of ​​a standalone (e.g., unattached) device that is considered non-critical and therefore does not require sterilization treatment. Still further, mounting mechanisms suitable for use in sterilization chambers may include one or more pairs or sets of complementary mating elements. Assemblies for restraining, maintaining, or positioning articles within the sterilization chamber may optionally include components made from UV-transparent materials to restrain the articles but not prevent the passage of sanitizing UV radiation. Configurations may include tubes, holding forks, positioning surfaces, or any other suitable structures. These assemblies may be configured and arranged to stationary receive articles, or they may translate, rotate, or otherwise move or be moved into position, e.g., in a clamshell manner or in combination with the movement of the target article, to capture, secure, or seize articles to be sterilized.

[0054] A system according to the present disclosure includes a sterilization device having a sterilization chamber and one or more radiation sources as described herein that operate to achieve sterilization of one or more target articles. In certain embodiments, the sterilization device operates according to a generated sterilization program (e.g., an algorithm, protocol, software program, or the like) that delivers a determined minimum dose of radiation as described herein. In such embodiments, one or more target articles are positioned within the sterilization chamber of the sterilization device, and exposure of the one or more articles to environmental conditions capable of sterilizing the articles (e.g., exposure to UV radiation) is initiated based on the determined sterilization exposure, including radiation intensity and exposure duration. After the sterilization conditions are initiated / imposed, one or more inputs may be collected and processed according to the generated sterilization program.

[0055] In certain embodiments, the systems herein operate according to one or more algorithms of a generated sterilization program that determine, calibrate, or adjust one or more of the system conditions that cooperate to irradiate the target articles with a determined minimum dose of radiation. The one or more algorithms may include provisions for determining whether the minimum dose has been reached in all portions of the target articles intended for sterilization. The one or more algorithms may be configured to determine where, when, and how the sterilization conditions can be terminated (i.e., an "end point" or "point for termination"). The one or more algorithms may also be configured to enhance the process for irradiating the target articles to avoid undesired damage to the one or more target articles being processed or for signaling the point at which the sterilization conditions end. Information processed by the one or more algorithms and utilized by the systems described herein may include, for example, determination of exposure to the sterilization conditions, temperatures at various locations within the sterilization chamber or on the surface of the target articles being sterilized, and the time the articles are exposed to the sterilization conditions. The collected information may be processed in a manner that improves the accuracy of the data measurements. For example, measured UV exposure may be integrated, averaged, or otherwise combined across multiple sensors to appropriately report / represent the disinfection power level present within the disinfection chamber. Additional examples of information collected via monitors, sensors, or another input mechanism (e.g., timers, user-input parameters, or the like) and then processed by one or more algorithms utilized in the operation of a system as described herein include the operational status and / or output of the UV radiation source, the level of cleanliness, the presence or absence of internal reflective or absorbing surfaces, the status or responsiveness of the UV radiation sensor, and other factors that induce variability in disinfection conditions over time. Surface soiling of the target article, or some other assessment of the condition of the target article and therefore its suitability for disinfection, may also be assessed by one or more detectors to ensure that the article has, for example, been properly pre-cleaned prior to disinfection.

[0056] The sterilization system may be operated manually, such that the generated sterilization program instructs one or more operators to load one or more test articles into the sterilization device, initiate a sterilization cycle, monitor system parameters necessary for executing an algorithm utilized to determine the endpoint of the cycle, and terminate the sterilization cycle in accordance with the algorithm. The sterilization system may also be operated semi-automatically, such that one or more of the tasks required for operation, such as monitoring system parameters, applying an algorithm to determine the endpoint of a given sterilization cycle, or terminating the sterilization cycle, are automated or otherwise directed by the generated sterilization program. Additionally or alternatively, the sterilization system may be operated fully automatically. For purposes of this disclosure, a fully automated system is one in which, after the generated sterilization program is initiated by an operator, each of the subsequent steps up to the end of the sterilization cycle is automated.

[0057] In certain embodiments, the systems disclosed herein include one or more processors capable of executing a generated sterilization program that directs one or more algorithms that perform sterilization and other peripheral tasks. For example, in some cases, the one or more algorithms are operable to calibrate system components, monitor sterilization conditions, and terminate a sterilization cycle. In these or other cases, the one or more algorithms may optionally be configured to analyze sensor data (e.g., digital images from a camera, digital data from an infrared sensor, electronic signals from mating components) to determine how a target article is positioned or otherwise oriented within the sterilization chamber. In this manner, the algorithm can evaluate any number of hot spots on the target article, cold spots on the target article, or other areas of interest on the target article, along with the current conditions / states of the sterilization chamber to which the radiation is being applied. Based on this evaluation, the algorithm can calculate the appropriate minimum dose of radiation in real time and adjust the generated sterilization program accordingly. This beneficial analysis can take into account the fact that a target article may not be positioned within the sterilization chamber in exactly the same way or orientation each time. Also, if the evaluation determines that the target article is too far out of position (e.g., too high, too low, rotated in an undesirable direction, or the like) to deliver the desired minimum dose of radiation, the system may alert the user to the erroneous condition, thereby allowing the user to correct the problem (e.g., reposition the target article, restart the algorithm, adjust other parameters, or the like). In some cases, the system includes the capability to automatically, manually, or both automatically and manually reposition the target. In these or other cases, the system includes the capability to adjust the radiation source to deliver more or less radiation to the chamber in a spatially preferred manner, thus correcting the erroneous position.

[0058] In some embodiments, one or more algorithms of the generated sterilization program evaluate and / or determine the endpoint of a sterilization cycle based on one or more system conditions, such as measurements from one or more sensors throughout the sterilization cycle, including at least 1) average or point exposure to sterilization conditions as measured by one or more sensors, 2) total exposure to sterilization conditions as measured by one or more sensors, 3) a combination of average exposure to sterilization conditions measured by one or more sensors considered in conjunction with the total exposure to sterilization conditions measured by one or more sensors, 4) duration or elapsed time of actual exposure to sterilization conditions, 5) temperatures, such as one or more of the temperatures measured within the sterilization chamber and / or one or more surface temperatures at locations of interest on target articles exposed to the sterilization cycle, and 6) operating conditions of system components, such as one or more radiation sources or sensors.

[0059] In some cases, one or more sensors may examine the surface of the target article and determine its cleanliness level. Also provided herein are methods for performing rapid, high-level disinfection of target articles. The disclosed methods can be performed under conditions less likely to damage or degrade the one or more articles being disinfected. For example, a method according to the present disclosure using UV radiation can achieve "rapid" high-level disinfection of a medical device in a matter of minutes (e.g., less than 10 minutes) while maintaining conditions such that the surface temperature of the target device being disinfected does not exceed a selected upper threshold, e.g., 55°C or less. In more specific embodiments, the methods described herein can use UV-C radiation to achieve a selected high level of disinfection within a time period considered acceptably short (i.e., "rapid") to allow the disinfected device to be reused in a clinical or treatment setting. Times for rapid, high-level disinfection of a target medical device include 5 minutes or less, 3 minutes or less, 1.5 minutes or less, and 1 minute or less. The fast disinfection cycle times provided by the methods described herein can lead to improved productivity and compliance with disinfection protocols, and can also avoid undesirable thermally accelerated radiation (e.g., UV) degradation of the target articles being disinfected.

[0060] A selected minimum dose of radiation exposure according to the present disclosure helps provide acceptable disinfection and helps mitigate or otherwise reduce degradation of component materials and / or joints or connections between components of the test article being disinfected. The provided methods, devices, and systems are suitable for eliminating a non-limiting, non-exhaustive range of microorganisms ("contaminants"), including, for example, Mycobacterium species, Escherichia coli, Staphylococcus aureus, Trichophyton mentagrophyton, Pseudomonas aeruginosa, Enterococcus hirae, Bacillus subtilis, Bacillus cereus, Clostridium sporogenes, Candida albicans, orthopoxvirus, enterovirus, Adenovirus type 5, and human papillomavirus. As will be appreciated, the minimum dose may be calculated based on any one or more of the radiation intensity map, contaminant type, disinfection requirements and characteristics of the target article, disinfection chamber characteristics, measured and / or calculated real-time data (e.g., sensor data), and other such factors as described herein.

[0061] Methods for determining acceptable disinfection conditions for a given target article, microorganism, or type of contamination are also provided. To better identify the conditions necessary for disinfection and reduce the potential for undesirable over- or under-exposure of articles to disinfection conditions, the methods described herein provide for setting and confirming the operating parameters of the disinfection devices and systems described herein using test data collected on the target microorganisms. For example, in specified embodiments, tests are conducted for one or more pathogens of interest, exposing known amounts of selected pathogens (e.g., live bacteria, dormant spores, fungi, molds, viruses, and the like) to controlled disinfection conditions (e.g., known doses of UV radiation, measured in terms of applied energy per unit area). The known amounts of selected pathogens can be deposited on a substrate, such as a glass / polymer / ceramic / metal substrate, and exposed to UV radiation from a UV source positioned to provide a known and controlled dose of UV radiation. At least one example of a system and device for performing such pathogen testing is disclosed in PCT / US2017 / 043264, entitled "Bioassay Carrier And Preparation Thereof," filed on July 21, 2017, and assigned to the same assignee as the present application, which application is incorporated herein by reference.

[0062] The radiation source can be operated to emit radiation energy of the desired disinfecting wavelength at a constant or some other controlled rate measured in joules per second (i.e., watts) or other units of measurement, and for a selected or selectable time (e.g., seconds) to achieve a selected radiation dose. In photonics and radiation studies, the area impinged by or passed through by radiation is measured in square meters (m 2 ) or square centimeters (cm 2 ) units. In these studies, the power level per unit area, or irradiance, sometimes called "fluence", is measured in watts / cm2 is defined as: In such an embodiment, for example, the target article may be irradiated directly from one direction, such as described above, with incident radiant energy measured at the plane of the target article substrate. The conditions necessary to achieve a specific log reduction in the population of viable pathogens being evaluated define the starting conditions for setting system parameters and disinfection cycle times for the disinfection systems described herein. Using such information, the disinfection cycle conditions are then verified in an actual disinfection system via one or more test runs with test articles inoculated, disinfected, and then analyzed to determine disinfection effectiveness. Depending on the results achieved at the starting conditions that produce the desired disinfection, the target dose and other conditions can be adjusted to achieve the desired level of disinfection (i.e., the minimum required dose for all surfaces intended to be disinfected) without unnecessarily risking overexposing the target articles to the disinfection conditions.

[0063] The devices and systems described herein may be configured to allow for calibration of one or more sources of sterilizing radiation and / or one or more detectors of sterilizing radiation. For example, in some cases, a sterilization chamber may be configured to allow for placement of one or more calibration sensors and, additionally or alternatively, one or more calibration articles that emulate actual target devices. In these cases, assessments may be made of the real-time irradiance level and / or total dose of sterilizing radiation energy (i.e., the time integral of the radiant flux) delivered to one or more areas within the chamber or to one or more surface portions of the target calibration article.

[0064] As described in this disclosure, the interior volume of the sterilization chamber may be modeled, and the surface of the target article to be sterilized (e.g., a medical probe or other medical device, a calibration device, or any other such object) may also be modeled. In addition, a first radiation map of the interior volume of the sterilization chamber may be generated by operating the sterilization device (i.e., irradiating the interior volume of the sterilization chamber) while collecting sensor data during a defined test operation. A second radiation map of the interior volume of the sterilization chamber may also be generated when a test article is placed in the interior volume of the sterilization chamber as sensor data is collected. The first and second radiation maps may be considered "measured radiation maps" because they represent radiation collected from the interior volume of the sterilization chamber by actual electronic sensors.

[0065] The data from the modeled sterilization chamber and the modeled target article can then be combined to determine a modeled radiation map. The modeled radiation map may be adjusted one or more times based on one or both of the first and second measured radiation maps. Alternatively, or in addition, sterilization cycle parameters may be adjusted to achieve acceptable confidence that the one or more modeled radiation maps represent the actual radiation dose delivered within the interior volume of the actual sterilization chamber when an actual test article is present.

[0066] The combinations, calculations, and analyses described herein are iterative and may be performed over time and repeated to improve accuracy. The combinations, calculations, and analyses can be used to generate any number of sterilization programs for any number of test articles. That is, the interior volume of any type of sterilization chamber can be modeled, and the surfaces of any type of sterilization target article can be modeled. Information from the models can be used to generate sterilization programs that can be loaded and run on an actual sterilization device of a given (i.e., modeled) type to sterilize a given (i.e., modeled) type of target article. In some cases, the generation of models and sterilization programs can occur in real time. By applying the processes and techniques of the present disclosure, the modeled data can be trusted, and the need for laborious measurements can be reduced or avoided.

[0067] It should be noted that to deliver a desired minimum dose of sterilizing radiation energy, readings provided by one or more calibration sensors or other sensors may be used to adjust the system's target dose, which may affect cycle time. These previously collected readings may also be used to adjust parameters within a generated program algorithm so that readings obtained in real time from a given sensor during an actual sterilization cycle are weighted differently. That is, when previously measured or modeled data does not match the real-time collected data, the previous data may be used to adjust one or more parameters used in the algorithm that account for degradation (e.g., predicted degradation) of the radiation source, changes in output of the radiation sensor over time / use, or other characteristics of the sterilization chamber that may occur over time or with use.

[0068] In some cases, to aid in calibration or actual disinfection, the sterilization chamber may employ one or more means for reliably and consistently placing test articles within the interior volume of the sterilization chamber. Reliably and consistently placing test articles within the sterilization chamber may include placing the test articles identically within the sterilization chamber each time within an acceptable tolerance. Remaining the test articles identically within the sterilization chamber each time may include any one or more of the following: same height, same depth, same dimensional orientation, same pre-clean, and any other distinguishing feature.

[0069] The means for ensuring consistent placement of the test articles within the interior volume of the sterilization chamber may include physical alignment indicia (e.g., ridges, openings, mating surfaces, visual alignment marks or cues, or the like). Such means may additionally or alternatively include other alignment indicia structures, such as electronic circuitry that provides visual, audible, tactile, or other feedback after proper or improper placement. And, such means may also comprise magnetic structures that are biased to attract proper placement and / or biased to repel improper placement. These means (i.e., physical, virtual, electronic, magnetic, or other alignment indicia) facilitate proper placement of the test articles within the interior volume of the sterilization chamber.

[0070] One embodiment of a sterilization device method may be summarized as including the acts of providing a sterilization chamber having an internal volume and a radiation source, the radiation source emitting ultraviolet-C (UV-C) radiation into the internal volume when in operation; identifying a UV-C radiation emission characteristic of the radiation source; identifying a structural configuration of the internal volume; estimating a UV-C radiation intensity map within the internal volume based on the UV-C radiation emission characteristic and the structural configuration of the internal volume; determining sterilization exposure of a target article based on the UV-C radiation intensity map; and confirming the sterilization exposure with actual measurements, which may be adjusted by one or more calibration values.

[0071] One embodiment of a non-transitory computer-readable storage medium may be summarized as containing executable instructions that, when executed by a processor, configure the processor to operate a sterilization system, the acts of operation including: identifying a sterilization chamber having an internal volume and a radiation source coupled to the internal volume, the radiation source emitting ultraviolet C (UV-C) radiation into the internal volume during operation; determining a UV-C radiation emission characteristic of the radiation source; receiving a structural configuration of the internal volume; receiving surface characteristics of a target article; estimating a UV-C radiation intensity map within the internal volume based on the UV-C radiation emission characteristic, the structural configuration of the internal volume, and at least one surface characteristic of the target article; and determining a disinfection exposure of the target article based on the UV-C radiation intensity map.

[0072] One embodiment of a sterilization system may be summarized as comprising a sterilization chamber having an interior volume, a radiation source coupled to the interior volume, the radiation source configured to emit ultraviolet-C (UV-C) radiation within the interior volume upon operation, and a control system configured to perform a plurality of expressly recited acts, including identifying a structural configuration of the interior volume, receiving surface characteristics of target articles (e.g., type of target article, placement of the target article, location of the target article, reflectivity of one or more surfaces of the target article, pre-cleaning or soiling of the target article, or some other characteristic), estimating a UV-C radiation intensity map within the interior volume based on the UV-C radiation emission characteristics, the structural configuration of the interior volume, and selected surface characteristics of the target article, and determining a disinfection exposure of the target article based on the UV-C radiation intensity map.

[0073] Disclosed herein are devices, systems, and methods for controlling disinfection exposure to target articles. The provided devices, methods, and systems are well suited for disinfecting medical devices, such as those classified by the CDC as critical or semi-critical items. Articles processed using the techniques described herein may or may not be connected or tethered to another device, system, or component. For example, in the context of medical devices, embodiments of the techniques described herein are suitable for disinfecting ultrasound probes. Currently, many ultrasound probes are tethered to a central processing unit, display, or the like, for example, by one or more cables that provide power or data communication capabilities to the probe. However, a wireless ultrasound probe need not be tethered to a device, system, or component. The devices, systems, and methods described herein are suitable for and can be adapted to accommodate tethered (e.g., wired) and untethered (e.g., wireless) devices. In addition to or instead of standalone disinfection devices, the devices, systems, and methods for controlling disinfection exposure on target articles disclosed herein may be incorporated into or otherwise associated with another system or device, such as an ultrasound system.

[0074] According to one embodiment, a target article subjected to a disinfection cycle as provided by the methods, devices, and systems described herein undergoes high-level disinfection. As used herein, "high-level disinfection" and "HLD" refer to a disinfection cycle that results in a high-level disinfection of at least 10% of one or more specified microorganisms on the target article. 5"Hand-killing" refers to a process sufficient to result in a logarithmic reduction in the survival rate of a pathogen. As used in this disclosure, "Hand-killing" generally means rendering a pathogen incapable of infecting (i.e., replicating, multiplying, and thus potentially adversely affecting some other host entity). Disinfection systems as described herein do not necessarily "kill" pathogens or remove pathogen residues. Instead, disinfection systems may operate to destroy pathogens at a molecular level, neutralizing or "quiescent" them. Pathogens remain "alive" and may be physically present, but are unable to reproduce.

[0075] The HLD disinfection procedure takes approximately 10 minutes. 4 from about 10 6 and in some embodiments, a disinfection procedure for "high-level disinfection" is sufficient to result in a log reduction in viability of one or more specified microorganisms between 10 and 100 microorganisms on an item. 6 However, in some cases, the disinfection cycles disclosed herein result in a log reduction of at least 10% of viable microorganisms on the target item. 6 The required reduction in the amount of viable bacteria remaining on the test article after disinfection will vary depending on the level of disinfection required or otherwise desired, and the level of disinfection provided can be adjusted by varying or adjusting the parameters of the disinfection cycle.

[0076] II. Devices and Systems FIG. 1 illustrates a sterilization system 100 in an operating environment 10. As shown in FIG. 1, the system 100 includes a sterilization chamber 110 having an interior volume 112. One or more radiation sources 120 are coupled to the interior volume 112 and, during operation, emit radiation into the interior volume 112. One or more sensors 130, 132 are physically, communicatively, electronically, or otherwise coupled to the interior volume 112 and configured to detect radiation and other such parameters (e.g., intensity, time, volume, and the like) within the interior volume 112. The one or more sensors 130, 132 may be configured in a manner specific to a certain type of target article 240 ( FIG. 2B ) to be sterilized within the sterilization chamber 110. For example, the sensor 130 may be configured in a manner suitable for detecting radiation intensity information on a surface portion of the target article.

[0077] In this disclosure, sensors configured to detect sterilizing radiation are referred to herein as sensors 130. In contrast, sensors configured to detect other non-sterilizing radiation phenomena, such as temperature, time, vibration, weight, humidity, liquid, continuity, and the like, are referred to herein as sensors 132. Thus, in addition to one or more sensors 130 (e.g., photodiodes) capable of detecting or quantifying the sterilizing intensity irradiated within the interior volume 112 and the target items 240 to be sterilized, the sterilization chamber 110 may also include one or more temperature sensors, one or more foreign object detection sensors (e.g., infrared emitters and detectors, cameras, accelerometers, load cells, or the like), one or more “door open” sensors (e.g., normally open or normally closed switches, photodetectors, conductive circuits, or the like), or any other type of non-sterilizing radiation sensor. These other, non-sterilizing radiation sensors may each be referred to individually or collectively as sensors 132.

[0078] The sterilization chamber 110, the radiation source 120, and one or more of the sensors 130, 132 are communicatively coupled to a controller 140. The controller 140 comprises a sterilization exposure determination unit 142 configured to execute the generated sterilization program, and a sterilization operation control unit 144. In addition to exchanging data with the sterilization chamber 110, the radiation source 120, and the sensors 130, 132, the controller 140 may communicate with one or more databases 150 and / or sterilization requirement inputs 160 in accomplishing its functions and operations.

[0079] 2A and 2B illustrate exemplary sterilization chambers, each of which may be referred to as an exemplary sterilization system 100. Collectively, FIGS. 2A and 2B may be referred to as FIG. 2. In FIG. 2, the sterilization system 100 is a high-level sterilization device comprising a sterilization chamber 110 and one or more radiation sources 120. The sterilization chamber 110 comprises a housing 202 having multiple sidewalls 204, a top 206, and a door 208 disposed on one of the sidewalls 204 for access to the interior volume 112. Although the door 208 in FIG. 2A is illustrated as being rotatably movable about a vertical axis, other door configurations may be used so long as they provide suitable access to the interior volume 112. It will be understood that opening the door 208 forms an access opening 212 in the sterilization chamber sidewall 204, which communicates with the interior volume 112. Other arrangements of the sterilization chamber are, of course, contemplated.

[0080] The interior volume 112 of the sterilization chamber 110 may include one or more reflective surfaces 230 configured to facilitate reflection of radiation emitted from the radiation source 120 so as to achieve rapid, low-temperature disinfection. The reflective surfaces are typically formed from one or more materials having a reflectivity of at least 30%. "At least 30% reflectivity" means that no more than 70% of incident UV radiation, particularly UV radiation in the UV-C range, is absorbed, with the remainder of the incident radiation being reflected via 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 paints, and alloys, derivatives, and copolymers thereof. In some variations, the reflective surface comprises 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 onto other substrates by various means to form the reflective surface. In certain embodiments, the reflective interior surfaces of the sterilization chamber are formed to have as much reflectivity as available manufacturing techniques provide. Such an approach facilitates sterilization processes that utilize high-intensity sterilizing radiation carried out at low temperatures.

[0081] The interior surface 230 of the interior volume 112 may be positioned and shaped to reduce absorption of UV radiation by the interior surface 230 and instead reflect and redirect the UV radiation within the interior volume 112 of the sterilization chamber 110 toward one or more target articles 240 positioned within the interior volume 112. The material selection and configuration of the interior volume 112 of the sterilization chamber 110 may be selected to promote preferential extinction of specific UV or other wavelengths of electromagnetic energy (i.e., longer wavelength radiation) that may contribute to temperature increases within the interior volume 112. That is, the shape of the interior volume 112 may contribute to fast and efficient direction of the radiation to the target articles 240. For example, radiation passing through the center of the interior volume 112 of the sterilization chamber 110, where the target articles 240 are to be positioned, and reflective materials employed in the interior volume 112 may be configured to contribute to reflection (e.g., re-emission or re-emission) of the radiation with low loss (i.e., approximately the same amount of energy returns from the surface as entered). In certain embodiments, the interior walls of the interior volume 112 are fabricated and configured to provide low-loss UV-C radiation emitted from one or more UV radiation sources 120 (not specifically shown in FIG. 2A for simplicity). Such embodiments increase the likelihood that UV-C radiation useful for sterilization will be reflected one or more times within the chamber until it strikes an item to be sterilized, where the radiation may be absorbed and lost, reflected, or re-emitted. In this way, for a given amount of total energy emitted into the chamber, which may include some amount of infrared or thermal energy, utilization of UV-C band energy useful in sterilizing target items 240, such as medical devices or instruments, is improved while reducing the amount of thermal heating of the target items 240.

[0082] As detailed herein, the disinfecting radiation utilized may be UV-C radiation, and in embodiments utilizing UV-C radiation, the one or more radiation sources 120 may be any commercially available device suitable for emitting sufficient UV-C radiation to perform high-level disinfection. When one source 120 of UV-C radiation is coupled to the disinfection chamber 110, that source 120 emits sufficient UV-C radiation to perform high-level disinfection, as detailed herein. When two or more sources of UV-C radiation are coupled to the disinfection chamber 110, the UV-C radiation sources 120 may each be capable of emitting sufficient UV-C radiation to perform high-level disinfection. Alternatively, in embodiments of the system 100 comprising two or more UV-C radiation sources 120 coupled to the interior volume 112 of the sterilization chamber 110, such radiation sources 120 may each, alone, emit insufficient UV-C radiation to achieve high-level disinfection, but when the individual outputs of UV-C radiation emitted from the two or more radiation sources 120 are combined, the total output of UV-C radiation is sufficient to achieve high-level disinfection.

[0083] The radiation source 120 may be coupled to the interior volume 112 through a variety of approaches. For example, the radiation source 120 may be locally mounted to the interior volume 112 to emit UV-C radiation within the interior volume 112, as shown in FIG. 2B for illustrative purposes. In a further example, the radiation source 120 may be remotely coupled to the interior volume 112. For example, the radiation source 120 may be a standard laser or a solid-state laser photodiode and may be employed as a sterilization energy source for a stand-alone sterilization chamber 110, along with appropriate light guides and couplers to emit UV-C radiation within the interior volume 112. Furthermore, in some embodiments, a direct or transmitted source of UV radiation may be steered or scanned along a target article 240 positioned within the interior volume 112 via mirrors or other devices. In other embodiments, the sterilization chamber 110 may include a movable mounting assembly, not specifically shown to avoid unnecessary clutter, within the interior volume 112 so that the target articles 240 may be positioned on a movable base and moved beyond the stationary radiation emission area. The controller 140 may control the radiation source 120 and the movable base to rotate or move in opposite directions to provide preferential exposure of the target articles 240 to UV radiation.

[0084] Although the devices, methods, and systems provided herein are described exclusively with reference to UV-C radiation as the sterilizing radiation within the sterilization chamber, this is for illustrative purposes only. The radiation or energy used in the sterilization system 100 may also be or include UV-A radiation, UV-B radiation, or even non-UV radiation, alone or in various combinations. It should further be understood that exposure of items to UV radiation within the interior volume 112 may be accomplished in a variety of ways.

[0085] Instead of UV radiation, such as UV-C radiation, some variations of the devices described herein may use a flash energy source. The flash energy source emits extremely high-intensity disinfecting radiation. The flash energy source can achieve high-level disinfection of one or more contaminated items in an acceptably short time. In some embodiments, the flash energy source can irradiate one or more items with disinfecting radiation at a high rate such that high-level disinfection is achieved within a time period selected from the group consisting of 10 seconds or less, 5 seconds or less, 3 seconds or less, and 2 seconds or less. The flash energy sources contemplated herein may be selected to emit any selected disinfecting radiation. For example, a disinfection system as described herein may include a flash energy source that emits electron beam, gamma rays, X-rays, gas plasma, or UV-C radiation. The biologically active mechanism of disinfection of the flash radiation source may differ for different sources. For example, gamma rays completely kill pathogens, while UV-C leaves pathogens alive but biologically sterilized and unable to reproduce.

[0086] When a flash energy source is used, one radiation source 120 of sterilizing radiation may be all that is needed within the interior volume 112 of the sterilization chamber 110. In such embodiments, to achieve a generally homogeneous or uniform radiation exposure on the target articles 240, the radiation emitted from the flash source may first strike a surface that diffuses and disperses the radiation before striking the target. In this case, the target is exposed to exclusively indirect, rather than direct, radiation. In other words, the sterilization device may be configured so that one or more radiation sources of any suitable type are located in a different portion of the device than the target. Because the energy spectrum emitted by some types of flash radiation sources can be broad, it may be beneficial to interpose a filter between the source and the target to allow only the spectrum of interest to enter the sterilization chamber. This filter may serve to minimize the presence of infrared energy within the chamber that does not sterilize but would otherwise heat the chamber, thereby increasing the temperature of the chamber and objects contained therein. Such a filter may also be useful when implemented with the other radiation sources mentioned herein. The devices and systems described herein may use a combination of sterilization energy sources. When two or more different sterilization energy sources are used, they may be applied sequentially, in parallel, or in various combinations and orders. The inclusion and use of two or more different sterilization energy sources may prove advantageous in situations where some 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 pathogens of interest in order to reduce the overall exposure of the target article 240.

[0087] Where the devices and systems described herein utilize UV ​​radiation, such as UV-C radiation, one or more UV radiation sources 120 and / or one or more UV radiation sensors 130 are positioned within the interior volume 112 of the sterilization chamber 110 to facilitate high-speed, low-temperature sterilization. Generally, the configuration of the sterilization chamber, the sterilizing radiation sources, and the sensors that detect the sterilizing radiation are selected to provide and confirm selected exposure of one or more articles to radiation and / or optimize penetration of radiation from the one or more sources to efficiently and reproducibly target articles.

[0088] As described, a disinfection chamber 110 according to the present disclosure may be coupled to a single source 120 of disinfecting radiation, such as a single UV-C radiation source. In such embodiments, the radiation source may be positioned at the top or bottom of the chamber. Alternatively, depending on the positioning of the items to be disinfected, the single radiation source 120 may be positioned at a side of the disinfection chamber or, if the disinfection chamber has multiple sides, at the intersection formed at the intersection of two sides. However, the devices and systems described herein are not limited to disinfection chambers having a single source of disinfecting radiation.

[0089] The sterilization chamber 110 included in the devices and systems 100 herein may utilize multiple radiation sources 120 of the same or different types; different embodiments of the sterilization chamber 100 having multiple sources 120 of sterilizing radiation are described in detail herein and illustrated in the accompanying figures. Such embodiments may be advantageous when the surface of one or more target articles 240 to be sterilized is more complex than a single, flat surface. For example, a target article 240 to be sterilized, such as an endotracheal probe or an ultrasound probe, may have two or more of the following surfaces: a front, a back, a side, and a dorsal and / or ventral surface that require sterilization. In such a scenario, it may be difficult to irradiate each surface of the target article 240 with high-intensity radiation using a single source or type of sterilizing radiation. Thus, in some embodiments of the sterilization device 100 described herein, the radiation source 120 and other structures are configured to sterilize one specific type of target. That is, while the radiation source 120 and / or other structures may provide irradiation of each surface of a specific target, the device would not function effectively if different types of targets were placed in the sterilization chamber.

[0090] Radiation sources 120 that can be employed in devices and systems such as those described herein are available in the art and include, for example, UV-C emitting lamps. UV-C emitting lamps, also referred to herein as "tubes," are commercially available from a variety of sources, including Philips Lighting BV, and are available in different shapes, sizes, input energies, and UV-C output ratings. UV-C tubes suitable for use as UV-C energy sources include low-pressure mercury vapor discharge lamps. However, the sterilization chamber is not limited to a particular UV-C source. Any source capable of emitting UV-C light within a selected UV-C wavelength with an output rating that contributes to sterilization of the target items 240 may be used in the devices disclosed herein. For example, in addition to or instead of one or more UV-C tubes, one or more lasers or photodiodes designed to emit UV-C light, or an array of sources, or a combination of several types of sources, may be used to apply sterilizing radiation within the sterilization chamber.

[0091] In certain embodiments, the one or more UV-C radiation sources included in the sterilization chamber 110 described herein provide a total UV-C output within the interior volume 112 of the sterilization chamber 110 selected to be at least 5 Watts of radiant flux. Selecting such a radiation source capable of delivering a high-power dose of radiation may be preferable for shortening sterilization cycles. That is, by selecting a high-power radiation source, energy is delivered at a faster rate, which may shorten the duration of radiation exposure and reduce the amount of heat generated by the radiation. In other cases, the one or more radiation sources 120 may be selected to provide a total UV-C output within the interior volume 112 of the chamber selected from a radiant flux of at least 10 W, at least 15 W, at least 20 W, at least 25 W, at least 30 W, at least 40 W, at least 50 W, at least 75 W, at least 90 W, and at least 100 W. When a UV-C radiation source is used as the source(s) 120 of disinfecting radiation, the frequency bands of UV-C light emitted from the source(s) may be selected from between about 240 nm and about 270 nm, and between about 255 nm and about 265 nm.

[0092] FIG. 3 is a diagram of an exemplary germicidal curve 300. To facilitate the description of the germicidal curve 300 of FIG. 3 and the understanding of the target dose of radiation, several concepts will now be explained. One such concept is the principle of proportionality of the energy fluence ratio. The energy fluence rate will be understood by those skilled in the art to be expressed in watts per square meter (W / m), which in this disclosure is photonic energy in the UV wavelength range. 2) coming from all directions through or across an infinitesimally small sphere of unit area (1) within the interior volume 112 of the sterilization chamber 110. Integrating this energy flow over this surface and over time calculates the "dose" in joules (J) delivered by the radiation source 120 and possibly at the surface of the target article 240. This energy may be absorbed and lost, re-emitted, reflected / scattered, or captured and transported elsewhere. At a given point or element surface within the sterilization chamber 110, the dose of energy delivered to that point or surface is the integral (i.e., sum) of the irradiance over the entire exposure. Another related term, W / m 2 In situations where unit irradiance is used and all incoming radiation comes from a single direction and strikes a surface, irradiance and fluence are the same. Fluence takes into account that radiation may enter and reach a surface from multiple directions, which is the case for the sterilization chamber 110 of the present disclosure due to the interior volume 112 having one or more radiation sources 120 and one or more reflective surfaces. The radiation is distributed broadly as an irradiation field of optical power intended to fully expose all surfaces of target articles contained within the sterilization chamber 110.

[0093] In this disclosure, the terms "fluence" and "irradiance" are sometimes used interchangeably, although it is recognized that there is a difference between the two terms. This disclosure, in at least some embodiments, concerns radiation impinging on a surface element unit from one side, entering from a hemispherical angle. That is, the radiation does not reach the surface from behind because it is blocked by the target object. Incoming radiation can impinge on the surface substantially normal (i.e., perpendicular) to the surface elements, as well as at all other angles of incidence up to ±90°. Depending on the field of view of the radiation collection optics in front of the detector, a wide or narrow range of angles of the incoming radiation can be suitably sampled. For narrow angles, fluence is essentially the same as irradiance.

[0094] When monitoring radiant flux within a sterilization system, it may be useful or quick and simple to collect narrow-angle incident radiation. When measuring radiant flux at one location within a chamber to assess the total (e.g., total) amount of energy impinging on a surface, a detector with a very wide acceptance angle may be selected. Additionally, a filter may be attached to the entrance optics on the detector, allowing only the passage and, therefore, measurement, of radiation at the desired disinfecting wavelength. This information is then incorporated into algorithms and models when correcting predicted fluence levels with the levels measured within the chamber or at the surface of the test device.

[0095] By characterizing the sterilization system 100 and a given target article 240, a "target article ratio" can be established between the radiation dose received at a specific point on the target article 240 (e.g., an area of ​​interest such as a determined "cold spot") and the average dose measured by the sensors 130 within the interior volume 112 of the sterilization chamber 110. The proportional irradiance ratio within the sterilization chamber 110 is then used to adjust (e.g., increase or decrease) the base radiation dose that would acceptably disinfect a standard surface (e.g., a test carrier inoculated with a known amount of a specific pathogen distributed over a defined surface during disinfectant potency testing) to a determined confidence level that a sufficient amount of radiation will be received on the surface of the target article 240 (e.g., an ultrasound probe) that is intended to be disinfected.

[0096] Disinfection of a target article 240 located at the center of the sterilization chamber 110 is achieved when the surface of the target article 240 intended for sterilization actually receives a fluence sufficient to achieve high-level disinfection (i.e., the desired logarithmic reduction in viable pathogens). The value of the fluence received at each point on the surface of the target article at a particular time may vary over time and may remain constant or within an acceptable range over a specified time interval, as measured by optical instrumentation and a discrete, stepwise mapping process. Embodiments of the sterilization system 100 have been characterized by such mapping, where irradiance levels are measured at multiple locations. This mapping provides confirmation of the incoming radiation at the location where the surface of a particular target article 240 (e.g., an ultrasound probe) will be positioned. Furthermore, computer simulation modeling of the sterilization chamber 110, the radiation source 120, and the presence of a modeled target article allows for the calculation of theoretical irradiance at a selected location. In testing by the inventors, these simulated radiation levels have been compared to actual measurements and found to agree well.

[0097] FIG. 3 illustrates the results of at least one study of the effectiveness of the disinfection system 100 described in this disclosure. The inventors performed detailed and extensive testing of such effectiveness against numerous pathogens, including Bacillus subtilis, Clostridium sporogenes, and many other pathogens. Exemplary results are shown in FIG. 3; the exact spores represented by the kill curve 300 are not relevant to the discussion. Instead, the teachings of FIG. 3 illustrate that the radiation used in the disinfection system of the present invention kills pathogens very rapidly early in the disinfection cycle by directly impinging on them. Over time, an extended disinfection cycle may be required to kill the last two logs of viable pathogen remnants. One theory for this is that pathogen entities neutralized early in the disinfection cycle physically shield surviving pathogen spores from at least some of the incoming radiation. Neutralizing these remaining survivors, which are "buried" beneath the earliest-affected spores, requires a longer radiation exposure.

[0098] 3, the vertical axis 302 is a logarithmic representation of the number of viable pathogen spores present within a determined area of ​​each target article 240 (tgtArt) (i.e., a negative binomial distribution of colony forming units (nb.CFU)). The first horizontal axis 304 represents the time course over which a disinfection cycle is performed (e.g., disinfection cycle duration). The first horizontal axis 304 is measured in seconds, although other time units could also be selected.

[0099] The second horizontal axis 306 of the sterilization curve 300 in FIG. 3 , below the first horizontal axis 304, represents the accumulation of radiation dose (e.g., energy fluence integrated over the exposure period) delivered to the surface of the target article 240 during a sterilization cycle. While radiation accumulation is generally linear with respect to time in FIG. 3 , it is recognized that other sterilization programs may modify the delivery of radiation in any manner, altering the distribution of energy fluence over time. The measure of radiation dose in FIG. 3 is sterilization units or “sterilization units,” which are intentionally non-limiting, non-standard units chosen for illustrative purposes. The sterilizing effect of certain radiation may kill pathogens by rendering them live but non-viable, which, at least in this disclosure, means that the pathogens cannot reproduce. Thus, pathogens are sterilized but not necessarily “dead.” Within the scope of this disclosure, the term sterilization unit (KU) may be understood as the accumulation of “counts” that describe the overall radiation exposure delivered to the interior volume 112 of the sterilization chamber 110 in a given cycle. Based on a periodic schedule (e.g., 300 milliseconds), data signals from the sensors 130 (e.g., photodiodes) are read. These values ​​may be corrected by one or more calibration factors and summed over the period of radiation exposure, for example, using the controller 140. Thus, for any given sterilization chamber 110, one or more radiation sources 120, one or more sensors 130, and the like, a determined radiation dose (e.g., total amount of radiation to a selected surface in joules, or in some cases, e.g., joules / cm) may be calculated. 2 It is understood that the area-specific dose (of a region) may be measured, calculated, or otherwise determined. However, in FIG. 3, which is not limited to any particular sterilization chamber 110, radiation source 120, or sensor 130, the term sterilization unit has been chosen to convey the relevant teachings of FIG.

[0100] Also depicted in Figure 3 are various viable pathogen measurements 308a-308f. A fitted curve 310 represents the amount of viable pathogens remaining during a disinfection cycle. Thus, the disinfection curve 300 may also be referred to in the art as a "survival curve."

[0101] As evident in Figure 3, one reason for applying a high radiation dose is to shorten the disinfection cycle time. This is because the radiation kills / disinfects a substantial portion of pathogens very quickly early in the disinfection cycle. By applying high-power levels of radiation, energy is delivered quickly, shortening the disinfection cycle time. This has the added benefit of reducing the chance of thermal heating of the target article 240. Figure 3 shows that an average 5 log 10 reduction in pathogens was achieved within the first 150 seconds with approximately 5000 KU, and an average 6 log 10 reduction in viable pathogens was achieved after only 650 seconds with approximately 9300 KU.

[0102] Several notable results were obtained during testing, some of which are depicted in Figure 3. First, disinfection via UV radiation exhibits an extremely "front-loaded" kill curve, with the majority of the germicidal effect occurring in the first tens of seconds after exposure. Second, no additional pathogen growth was observed on the target article 240 after irradiation, even when the target article 240 was initially heavily inoculated with pathogens (i.e., 7 x 10 spores). Third, in addition to rapidly reducing the pathogen population to low levels, the disinfection system 110 is also effective in killing the majority of viable pathogen spores on the target article 240. And fourth, as evident after 1600 seconds, very few viable pathogen spores may still survive the disinfection radiation dose (e.g., measured at 308 f). At the limit of very long exposures, disinfection results in "sterilization" with no viable entities remaining.

[0103] Referring again to FIG. 2 , each radiation source 120 may emit radiation according to its own parameters and characteristics. For example, the aging of a radiation source 120 may be directly related to its light-emitting characteristics. Furthermore, the passage of time after a radiation source is turned on may also affect the UV-C radiation emitted by the radiation source 120. For example, the intensity of the radiation emitted by the radiation source 120 may be time-dependent as part of its natural operation, and may include a specific pattern of waveform / change, such as a continuously decreasing, continuously increasing, or fluctuating waveform. Furthermore, each radiation source 120 may have different operating states for emitting radiation. For example, each radiation source 120 may have characteristics that cause each source to emit radiation at different power levels, even when the output power of two or more radiation sources 120 is otherwise expected to be the same. Each radiation source 120 may also emit radiation at different angles, substantially parallel to one another, or a combination of orientations during operation. Multiple radiation sources may be controlled by a common signal and common parameters. Alternatively, two or more radiation sources may be independently controlled via independent control signals and parameters.

[0104] The sterilization chamber 110 described herein may be configured to form multiple sterilization zones within the interior volume 112. In such embodiments, the sterilization chamber 110 and / or one or more target articles 240 to be sterilized may be further configured such that the one or more target articles 240 to be sterilized are positioned within the sterilization zone in a selected position, alignment, orientation, or the like. As used herein, the term "sterilization zone" refers to an area within the sterilization chamber that is irradiated with a particular intensity of sterilizing radiation during a sterilization operation. In certain embodiments, the interior volume 112 is coupled to one or more sources 120 of UV-C radiation, which, independently or in common, may have a sterilization intensity of at least about 1,500 μW / cm. 2The sterilization zones may be selected and configured to deliver UV-C radiation at varying radiation intensities, or irradiances (also referred to as "power" for or through a particular unit area), of UV-C radiation. In this manner, more precise delivery of radiation may be possible within the interior volume 112 of each chamber through independent or common control of multiple sterilization zones and radiation sources.

[0105] In some embodiments, the one or more sources 120 of UV-C radiation 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 radiation sources 120 may be configured to emit UV-C light within a band selected from between about 240 nm and about 270 nm, ... 2 to approximately 5,000 μW / cm 2 In a further embodiment, one or more UV-C radiation sources 120 may be selected and arranged to provide one or more disinfection zones, wherein the irradiance of the UV-C radiation projected into the disinfection zones is between about 1,500 μW / cm 2 to approximately 2,000 μW / cm 2 Approximately 1,500 μW / cm 2 to approximately 2,500 μW / cm 2 Approximately 1,500 μW / cm 2 to approximately 3,000 μW / cm 2 Approximately 2,000 μW / cm 2 to approximately 2,500 μW / cm 2 Approximately 2,000 μW / cm 2 to approximately 3,000 μW / cm 2 Approximately 2,000 μW / cm 2 to approximately 3,500 μW / cm 2 Approximately 2,000 μW / cm 2 to approximately 2,500 μW / cm 2 Approximately 2,000 μW / cm 2 to approximately 2,750 μW / cm 2Approximately 2,500 μW / cm 2 to approximately 2,600 μW / cm 2 Approximately 2,500 μW / cm 2 to approximately 2,750 μW / cm 2 and approximately 2,500 μW / cm 2 to approximately 3,000 μW / cm 2 or other similar values.

[0106] In some embodiments, the sterilization zone created within the interior volume 112 is characterized by the application of sterilizing radiation at a substantially uniform irradiance within the zone. As used herein with respect to a sterilization zone, the term "substantially uniform" refers to a zone in which the irradiance of the sterilizing radiation does not vary by more than 10% throughout the 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 sterilization zone in which the intensity with which the sterilizing radiation is applied to the surfaces of the articles to be sterilized does not vary by more than an amount selected from among ±30%, ±25%, ±20%, ±15%, ±10%, and ±5%, or another similar value, across any portion of those surfaces. The sterilization zone may be redefined or custom-tuned for different types of target articles 240, different regions of the target articles 240 intended to be sterilized, different operating conditions of the radiation source 120, or for other reasons. Furthermore, the sterilization zone may be dynamically adjusted, collectively adjusted, independently adjusted, or adjusted in some other manner. For example, if it is determined that the variation in radiation intensity within the disinfection area exceeds a threshold, e.g., 10%, the disinfection area may be redefined, e.g., into two or more disinfection areas according to a generated disinfection program or by some other logic.

[0107] Although sterilization does not require that radiation be uniformly applied, it can be useful to have reasonably uniform irradiance within the local volume / region in which the target article 240 is positioned. The uniform distribution can be used to verify the actual power level established where one or more surfaces of the target article 240 are being sterilized. For example, when a selected volume or region is uniformly irradiated, the radiation dose reaching one or more surfaces within the selected volume or region can be inferred from sensor measurements of radiation within the selected volume or region. In this way, the minimum dose of radiation determined to achieve the desired level of sterilization can be applied to the intended surfaces, reducing the possibility of over-exposure.

[0108] One or more interior walls 230 defining the interior volume 112 of the sterilization chamber 110 may be configured to cooperate with one or more sources 120 of sterilizing radiation to irradiate one or more sterilization zones within the interior volume 112 with high-intensity sterilizing radiation. For example, one or more walls, and, if included, one or more reflective surfaces included in the sterilization chamber, may be configured to function in cooperation with one or more sources 120 of sterilizing radiation to provide one or more sterilization zones. In some embodiments, the interior volume of the sterilization chamber is defined by one or more side walls having a top wall and / or a bottom wall. In such embodiments, the source 120 of sterilizing radiation may be positioned on or in any of the side walls, the top wall, the bottom wall, or at any junction between two or more side walls, one side wall and one bottom wall, and any of the side walls and the top wall. Additionally or alternatively, the generated sterilization program may control one or more radiation sources 120 to irradiate one or more desired levels of radiation to one or more different sterilization zones defined within the interior volume 112 of the sterilization chamber 110. And, the radiation intensity irradiated to one sterilization zone may be simultaneously different from the radiation intensity irradiated to another sterilization zone.

[0109] The one or more walls 230 defining the interior volume 112 of the sterilization chamber 110 can provide any one of a number of cross-sectional shapes for the chamber. For example, in certain embodiments, the one or more walls 230 are configured to provide the interior volume 112 with a circular or polygonal cross-section, such as a rectangular, triangular, hexagonal, or octagonal cross-section. In some embodiments, the sterilization chamber 110 is configured such that the interior volume 112 is defined by multiple walls and the cross-sectional shape of the interior volume is a rectangular or octagonal parallelepiped. In still other embodiments, the interior volume 112, or a portion thereof, may be in the shape of a circle, a parabola, a double ellipse, or other shape. In some cases, the interior walls 230 of the interior volume 112 may be added, removed, or alternatively or additionally rearranged so that a sterilization chamber having an interior volume defined by a first cross-sectional shape may be modified to have an interior volume defined by a second, different cross-sectional shape.

[0110] Embodiments of the sterilization chamber 110 may include a reflector (not shown specifically for simplicity) that completely or partially backs one or more sterilizing radiation sources 120; in such embodiments, if the sterilizing radiation source 120 emits UV radiation, e.g., a tube emitting UV-C radiation, the reflector may be a parabolic surface with the UV-C radiation source at or near its focal point. Such a configuration may result in the emitted light being transmitted as nearly parallel rays after initial reflection from the parabolic reflector. Of course, other reflector geometries, UV radiation source placements, and resulting radiation fields are possible. When a tube emitting UV-C radiation is used as one or more sources of sterilizing radiation, in some embodiments, the rated total power delivered by the source tube (i.e., the UV-C fluence exiting the source, integrated over the surface area encompassing the source) may be in the range of about 20 W to about 200 W. It should be noted that while the input power consumed by the disinfecting radiation sources 120 (e.g., UV tubes) is related to and informs of the output UV power delivered by these sources, the relationship is not linear and the relationship typically changes over time. However, in certain embodiments, the input power to UV tubes used in a disinfection chamber 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.

[0111] One or more sources 120 of sterilizing radiation may be positioned around one or more sidewalls 230 of the interior volume 112 in a manner that results in a selected intensity of radiation (e.g., an intensity of energy as described with respect to the sterilization zones) being applied to one or more sterilization zones within the interior volume 112. The one or more sources 120 of sterilizing radiation may be positioned around the interior volume 112 to provide a particular radiation intensity to the sterilization zones. For example, in embodiments of the interior volume 112 having one or more sidewalls 230, two or more sources 120 of sterilizing radiation, such as two or more sources 120 of UV-C radiation, may be positioned along one or more of the evenly spaced-apart sidewalls. In embodiments with multiple sidewalls, one or more sources 120 of sterilizing radiation may be positioned at one or more corners of the sidewalls. If the sterilization chamber includes at least one top or bottom wall or surface, one or more sources of sterilizing radiation 120 may be positioned on the top and / or bottom wall or surface to provide a particular level of sterilizing radiation directed toward one or more sterilization areas formed within the interior volume 112. In certain embodiments, if the interior volume 112 of the sterilization chamber 110 is configured with two or more side walls 230 and a bottom wall 230, with a UV radiation source 120 at each corner formed between the side walls, and at least one UV radiation source 120 positioned on the bottom wall, the input power of the tubes at each corner may be at least 50 W, and the power of the bottom tube or tubes, if included, may be at least 30 W.

[0112] To facilitate positioning of target articles 240 within the interior volume 112, the sterilization chamber 110 may be provided with a movable base, e.g., a suspension assembly, that positions one or more target articles 240, e.g., ultrasound probes or other medical instruments, within the chamber. The suspension assemblies described herein serve to consistently position one or more articles to be sterilized within the sterilization chamber. In these cases, if the sterilization chamber is designed to form one or more sterilization zones, providing a suspension assembly allows for consistent and repeatable positioning of one or more articles to be sterilized within the sterilization zones, thereby ensuring that the one or more articles are exposed to high-intensity radiation during the sterilization cycle.

[0113] In certain embodiments, a suspension assembly 242 may be provided to position the target articles 240 in a central portion of the sterilization chamber where a sterilization zone of high-intensity radiation is formed. In some variations, the suspension assembly includes a slot at the top of the assembly that extends to a central portion of the top of the sterilization chamber, for example, when the articles are connected to a cable that may then exit the chamber. In some cases, the suspension assembly 242 may include one or more control mechanisms configured to receive control signals from a processing device, such as the controller 140. In these or other cases, the suspension assembly 242 may operate according to a generated sterilization program to adjust the position of the target articles 240 within the sterilization chamber 110 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 in a sterilization cycle), or some other number of dimensions. In some cases, the suspension assembly 242 includes registration features to aid in aligning the target articles 240. In some cases, the suspension assembly 242 is permanently or semi-permanently secured to the target articles 240 so that they do not move during a sterilization cycle after they are placed within the interior volume of the sterilization chamber 110 .

[0114] As will be appreciated, the location of the shape and size of interior volume 112, the location, shape, and light-reflecting properties of the reflective interior sidewalls that define interior volume 112, the quantity and location of radiation sources 120, the movement of the movable base, and other structural configurations of interior volume 112 can all affect the radiation intensity delivered to the disinfection area within interior volume 112. All such structural configurations of and / or within interior volume 112 are referred to herein as the "structural configuration" of interior volume 112.

[0115] The number and location of the one or more sensors 130 included in the sterilization device 100 are also selected to provide high-rate, high-level disinfection at low temperatures. For purposes of this specification, a sensor 132 includes any device or assembly of components that collects and measures environmental conditions. When referring to one or more sensors 130 for detecting sterilizing radiation within a sterilization chamber, the one or more sensors 130 are each a device or assembly of components that can collect information about the sterilizing radiation present within the sterilization chamber, sense or measure the amount of sterilizing radiation within the sterilization chamber, and amplify or process the collected information about the sterilizing radiation. Furthermore, in the context of this specification, a sensor 130 is considered to be positioned within the sterilization chamber, whether or not it is positioned within or directly exposed to the interior of the sterilization chamber, such that any component of the sensor 130 can detect, measure, transmit, process, or communicate processed information about the sterilizing radiation present within the sterilization chamber.

[0116] Each of the one or more sensors 130, 132 included in the interior volume 112 may be capable of detecting and communicating information such as total radiation dose, exposure rate over time, and the like to the controller 140 (FIG. 1). For example, if UV-C light is used as the sterilizing radiation, the sensor 130 may sense the UV-C dose received by the target items 240 and / or the amount of UV-C radiation emitted by one or more UV-C radiation sources 120 included in the sterilization device. In some embodiments, the UV-C sensors 130 included in the sterilization devices described herein may be one or more photodiodes fixedly or movably positioned within the interior volume 112 of the sterilization chamber 110. In other embodiments, the one or more sensors 130 may include one or more light-conducting components, such as lenses, mirrors, filters, and other optical elements, used to collect radiation within the chamber and may also include fiber optic cables or light pipes that conduct the collected sterilization energy to a detector, such as a photodiode. In some variations, the sensors 130 in the sterilization chamber 110 are configured with a bandpass optical filter or other electromagnetic filter in front of them so that only radiation within the spectrum of interest is sensed. In some embodiments, one or more sensors 130 may be positioned on or incorporated into one or more articles to be sterilized. Positioning one or more sensors 130 on one or more target articles 240 to be sterilized may allow for more accurate readings of the sterilizing radiation reaching the articles 240. The devices described herein may, for example, include one or more sensors 130 utilizing multiple photoconductors positioned to monitor direct and indirect sources of sterilizing radiation.Light 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 pipes" formed from glass, polymers, or other simple, optically transparent materials that trap and confine light within themselves and conduct light with low loss. "Light pipes," as used herein, are typically more suitable for conducting light over short distances to prevent unwanted losses. A lens collects the radiation and directs it to a detection device, or the collected radiation can be transported to another location for measurement.

[0117] In some embodiments, it may be beneficial to have one sensor 130 or set of sensors 130 for detecting the global (i.e., total) radiation dose irradiated into the internal volume 112 and another sensor 130 or set of sensors 130 for checking or monitoring each disinfection area within the internal volume 112.

[0118] In one embodiment, the sterilization system 100 is controlled by a controller 140 (FIG. 1) that commands operation of the radiation source 120 at a specified power level and for a particular time period, i.e., to reach a determined cumulative threshold radiation dose. For example, if UV-C radiation is used as the sterilization radiation, in a particular embodiment, the predetermined threshold radiation dose is about 50,000 μJ / cm 2 and approximately 10,000,000 μJ / cm 2 In some such embodiments, the dose may be selected from between, for example, about 50,000 μJ / cm 2 and approximately 750,000 μJ / cm 2 Approximately 50,000 μJ / cm 2 and approximately 650,000 μJ / cm 2 Approximately 50,000 μJ / cm 2 and approximately 500,000 μJ / cm 2 Approximately 50,000 μJ / cm 2 and approximately 450,000 μJ / cm 2Approximately 50,000 μJ / cm 2 and approximately 350,000 μJ / cm 2 Approximately 50,000 μJ / cm 2 and approximately 250,000 μJ / cm 2 and approximately 50,000 μJ / cm 2 and approximately 100,000 μJ / cm 2 or other similar values, such as approximately 50,000 μJ / cm 2 and approximately 1,000,000 μJ / cm 2 In further such embodiments, the dose may be selected from between about 150,000 μJ / cm 2 and approximately 750,000 μJ / cm 2 Approximately 150,000 μJ / cm 2 and approximately 650,000 μJ / cm 2 Approximately 150,000 μJ / cm 2 and approximately 500,000 μJ / cm 2 Approximately 150,000 μJ / cm 2 and approximately 450,000 μJ / cm 2 Approximately 150,000 μJ / cm 2 and approximately 350,000 μJ / cm 2 Approximately 150,000 μJ / cm 2 and approximately 250,000 μJ / cm 2 or other similar values. In still further such embodiments, the dose is about 250,000 μJ / cm 2 and approximately 750,000 μJ / cm 2 Approximately 250,000 μJ / cm 2 and approximately 650,000 μJ / cm 2 Approximately 250,000 μJ / cm 2 and approximately 500,000 μJ / cm 2 Approximately 250,000 μJ / cm 2 and approximately 450,000 μJ / cm 2 and approximately 250,000 μJ / cm 2 and approximately 350,000 μJ / cm 2 or other similar values.

[0119] Figure 4 illustrates details of an exemplary controller 140. As shown in Figure 4, the controller 140 may include a processor 174 and an interfacing unit 176 with at least one analog-to-digital converter (ADC) unit 178. The interfacing unit 176 may communicate with one or more of the sterilization chamber 110, the radiation source 120, the sensor 130, the database 150, and / or the sterilization requirement input 160 regarding data / information related to the control of the sterilization operation. The ADC unit 178 may convert analog data, such as data detected by the sensor 130, into digital data suitable for processing by the processor 174.

[0120] The controller 140 may also include a storage unit 180 having a sterilization exposure determination unit 142 and a sterilization operation control unit 144 housed therein. The sterilization exposure determination unit 142 may include an internal volume patterning unit 184, a radiation source patterning unit 186, a target article patterning unit 188, a radiation intensity map generation unit 190, and a calibration unit 192. The sterilization operation control unit 144 may include an operation unit 194, a temperature control unit 196, and a radiation intensity control unit 198. The sterilization exposure determination unit 142 and the sterilization operation control unit 144 may be stored in one or more storage media as software, embedded firmware, programmable logic, combinations thereof, or other suitable forms of storage.

[0121] The sterilization exposure determination unit 142 is generally configured to determine sterilization exposure for target articles 240 placed within the sterilization system 100, which includes the sterilization chamber 110 and the radiation source 120. Specifically, the interior volume patterning unit 184 is configured to identify a structural configuration of the interior volume 112 of the sterilization chamber 110. The radiation source patterning unit 186 is configured to identify at least one radiation emission characteristic of the radiation source 120. The target article patterning unit 188 is configured to identify at least one structural configuration and material characteristic of the target article 240. The radiation intensity map generation unit 190 is configured to generate a radiation intensity map based on the UV-C radiation emission characteristic of the radiation source 120, the structural configuration of the interior volume 112, and the structural configuration and material characteristic of the target article 240. The generated radiation intensity map indicates radiation intensity values ​​of one or more sterilization zones within the interior volume 112 of the sterilization chamber 110. The calibration unit 192 is configured to generate calibration values ​​based on actual radiation intensity data detected by the sensor 130 (FIG. 2B). The actual radiation intensity data may be acquired with a calibration target positioned within the interior volume 112 and the radiation source 120 operating in a manner comparable to the manner in which the radiation intensity map is generated. As described herein, the generated calibration values ​​are, in some cases, weighting coefficients, attenuation coefficients, or other such coefficients used to adjust the values ​​generated by the sensor 130 in actual operation. Details of the operation of the disinfection exposure determination unit 142 are described further herein with respect to exemplary operation.

[0122] The sterilization operation control unit 144 is configured to control the sterilization operation of the target articles 240 according to the generated sterilization program based on the sterilization exposure (e.g., minimum dose) determined by the sterilization exposure determination unit 142. The radiation dose may be based on a radiation intensity map and may define the duration for which each sterilization area receives radiation. Specifically, the operation unit 194 may implement a sterilization operation based on the determined dose. The operation may include movement of the target articles 240 within the interior volume 112, the power state of the radiation sources 120, the duration for which each radiation source 120 is turned on / off during operation of a sterilization cycle, and other factors.

[0123] The temperature control unit 196 is configured to control the sterilization operation based on detected temperature information of the target article 240 and / or the sterilization area within the interior volume 112. The radiation intensity control unit 198 is configured to control the sterilization operation based on detected radiation intensity at the sterilization area within the interior volume 112.

[0124] For example, based on the radiation intensity data detected by the sensors 130, and if the radiation intensity control unit 198 determines that the required minimum dose has not yet been achieved, the radiation intensity control unit 198 may cause the operating unit 194 to continue operation for a time interval configured to bring the total exposure to sterilizing radiation to a selected (e.g., minimum) threshold dose. In such an embodiment, the selected threshold of sterilizing radiation may be determined based on the radiation dose determined by the sterilizing exposure determination unit 142. For example, the sterilization system 100 may be configured and controlled to stop a sterilization cycle after it is determined that one or more of the following conditions are met: 1) each of the sensors 130 receives a predetermined (minimum) dose of sterilizing radiation; 2) the average dose received by the sensors 130 reaches a threshold (e.g., minimum) dose; or 3) at least one individual sensor receives a first threshold (e.g., minimum) dose and all remaining sensors 130 receive a second threshold (e.g., minimum) average dose. 4) One or more sensors 130 positioned to receive the sterilizing radiation directly receive a first threshold (e.g., minimum) dose, and one or more additional sensors positioned to monitor total or indirect radiation receive a second threshold (e.g., minimum) dose. 5) A first group of two or more sensors receive an average dose that meets the first threshold (e.g., minimum) dose, and a second group of two or more additional sensors receive an average dose that meets the second threshold (e.g., minimum) dose. As used herein, the terms “first threshold dose” and “second threshold dose” do not necessarily refer to different values. The first and second threshold doses of sterilizing radiation can be the same, or in other embodiments, the first and second threshold doses can be different.

[0125] In certain embodiments, the sterilization process herein is performed at an acceptably low temperature. In one embodiment, if the surface temperature of the articles being sterilized is to be maintained below a certain threshold, one or more temperature sensors 132, such as one or more infrared temperature sensors 132, may be used to monitor and communicate the surface temperature of the articles 240 being sterilized. Alternatively, simply monitoring the air temperature within the interior volume 112 or the temperature of one or more of the interior walls 230 may be sufficient. If the air temperature or wall temperature within the sterilization chamber 110 is monitored, the monitoring location may be selected to reasonably detect the surface temperature of the one or more target articles 240 being sterilized with reasonable accuracy. In such an embodiment, a location for temperature monitoring within the interior volume 112 of the sterilization chamber 110 that correlates to the surface temperature of the one or more target articles 240 being sterilized may be selected via testing to monitor the surface temperature of the target articles 240 and identify an area or location within the chamber that exhibits a temperature that appropriately correlates to the surface temperature of the target articles 240. In such cases, the sterilization chamber may include one or more ambient temperature sensors 132 that monitor and communicate the ambient temperature of the interior volume 112 of the sterilization chamber 110 while the sterilization cycle is being performed.

[0126] Based on the temperature data detected by sensor 132, temperature control unit 196 may control operating unit 194 to adjust its operating state. For example, if the temperature is above a threshold value, temperature control unit 196 may operate to reduce the heat capacity of interior volume 112, thereby cooling interior volume 112, and in achieving this cooling, may, as an additional effect, reduce the power output of radiation source 120. For example, light tubes that produce UV-C radiation have been found to operate with acceptable efficiency at temperatures between about 35°C and about 45°C. In some embodiments, the temperature control unit 196 as described herein may be configured to: 1) preheat the interior volume 112 to a temperature within a selected or selectable temperature range for the one or more radiation sources 120 of sterilizing radiation prior to the initiation of a sterilization cycle; and 2) actively heat or cool the interior volume 112 to maintain a temperature range that does not result in undesirable degradation of the target article 240 being processed and does not move below the threshold temperature range selected for the one or more radiation sources 120 of sterilizing radiation. To maintain the interior volume 112 of the sterilization chamber 110 at an acceptable temperature, the temperature control unit 196 may include or otherwise command one or more heat sources. In such embodiments, the heat source(s) may be one or more radiation sources 120 (e.g., one or more UV-C tubes) or any other suitable heat source or heating element, including known electric, infrared, and radiant heating devices. It may comprise an element.

[0127] The sterilization system 100 and its components described herein may or may not be portable. The system 100 and its components according to the present disclosure may be configured to suit selected parameters of the particular context and application in which the device and system will be used. In embodiments in which the housing is portable, the housing may be moved near the item, or portion of an item, requiring high-level sterilization. In certain contexts, the portability of the devices and systems according to the present disclosure is advantageous because such portability reduces or eliminates the need to move the target item 240 to be sterilized to the device or system 100 itself. When embodiments are portable, the devices and systems may be configured to utilize any power source typically located in a home, clinic, or hospital environment. Alternatively, in portable device or system 100 embodiments as described herein, one or more components of the system 100 may be powered by one or more batteries or other portable power sources to reduce or eliminate the need for access to a stationary power source. Various batteries, battery technologies, and power management techniques are well known in the art and may be utilized in the devices and systems according to the present disclosure.

[0128] The strategy of the present disclosure is to determine an appropriate radiation dose (i.e., a minimum dose) for sterilizing any type of target article 240. This strategy facilitates sterilization of all surfaces of the intended target article 240, regardless of the article's shape. To facilitate this strategy, the interior volume 112 of the sterilization chamber 110 is modeled, the radiation pattern within the empty chamber is modeled, the target article 240 is modeled, and the radiation pattern within the chamber when the target article 240 is present is modeled. Based on the model, a sterilization program is generated that delivers sufficient radiation into the interior volume 112 of the sterilization chamber 110 when the target article 240 is present to achieve high-level disinfection (HLD). When the sterilization program is loaded into the sterilization system 100 and executed using the controller 140, for example, a minimum dose of radiation is delivered and the target article 240 is disinfected. Implementation of the strategy may be supplemented by additional procedures or structures. For example, a calibration device may operate within the sterilization chamber 110 to collect data used to validate one or more of the model, radiation map, and sterilization program. One or more on-board sensors 130, 132 are used to supplement information in one or more of the models and radiation maps, and the sensor information may further be used to control some operations of the disinfection program.

[0129] 5A-5E are views of the sterilization chamber 110 taken along the lines of FIG. 2B. The sterilization chamber 110, as illustrated, includes an interior volume 112, one or more radiation sources 120, one or more sensors 130, and a suspension assembly 242. Other structures and features of the sterilization chamber 110 are not shown for clarity of illustration relative to the present description.

[0130] In some cases, the sterilization chamber 110 of FIG. 5 may be deployed for use in a medical facility, a manufacturing facility, or some other location. In these locations, the sterilization chamber 110 is used to sterilize any number of types of target articles. This first type of sterilization chamber 110 may be referred to as a deployed sterilization chamber, a commercial sterilization chamber, a production sterilization chamber, or other such terminology. In other cases, the sterilization chamber 110 may be used to create a three-dimensional model or radiation intensity map of the sterilization chamber, or this second sterilization chamber may be used for other testing or data collection purposes. This second type of sterilization chamber may be referred to as a test sterilization chamber, a data collection sterilization chamber, or other similar designation. It will be appreciated that in some cases, the first and second types of sterilization chambers are the same and in other cases are different. In some cases, a single sterilization chamber may operate as a testing or data collection sterilization chamber at some times and as a deployed or commercial sterilization chamber at other times.

[0131] The sterilization chamber 110 in Figure 5A is empty. The sterilization chamber 110 in Figures 5B-5E contains a target article 240 coupled to a suspension assembly 242 within the interior volume 112. Figures 5A-5E may be collectively referred to herein as Figure 5.

[0132] The sterilization chamber 110 of FIG. 5 can be operated to generate any number of maps of radiation intensity of the sterilization region within the interior volume 112. The radiation intensity maps are developed / obtained based on the structural configuration of the sterilization chamber 110 and the radiation emission characteristics of the particular radiation source 120 coupled to the sterilization chamber 110. Various radiation maps can be formed by operating the radiation source 120 at different power settings, in different sequences, for different durations, or in any other manner. Separate radiation maps can be generated based on the independent operation of each individual radiation source 120. In some cases, radiation maps are generated after the sterilization system 100 (FIG. 1) has been operated in the field. In this manner, periodically generated radiation maps can be compared to one another to track certain functional characteristics of a particular system (e.g., buildup of dirt or contaminants on the radiation source, aging of the radiation source, changes in detector sensitivity, and other characteristics). In at least some of these cases, exceeding one or more thresholds when comparing such generated radiation maps may trigger instructions to maintain the system (e.g., an indicator on the user interface, a broadcast message, a system reset or shutdown, or the like).

[0133] In some cases, such as in FIG. 5B , a radiation map may be generated taking into account a target article 240 positioned within the interior volume of the sterilization chamber. That is, the generation of the radiation map takes into account the radiation reflection, light blocking, and / or absorption or other optical properties of the target article to be sterilized. For example, the surface structural configuration of the target article 240 and the surface material of the target article 240 affect the determination of radiation intensity within the interior volume 112 of the sterilization chamber 110. The presence of the target article 240 predictably alters the radiation received at the sensor 130. A first data set measured and collected from the sensor 130 during a first sterilization cycle by operating the sterilization chamber 110 without a target article may be used to generate a first radiation map. A second set of data measured and collected from the sensor 130 by positioning the target article 240 in the interior volume 112 of the sterilization chamber 110 and then operating the sterilization chamber 110 through a second identical sterilization cycle may be used to generate a second radiation map. The first and second radiation maps are compared to one another to generate a set of data representative of the effect on radiation delivered within the interior volume 112 caused by the target item 240 .

[0134] Information for supplementing or otherwise correcting the radiation map may be collected in other ways as well. For example, in some cases, the target article 240 may have a radiation-sensitive material 241 applied to some or all of its surface. In these cases, if the coated target article 240 is irradiated while in a sterilization chamber, the radiation-sensitive material 241 will be affected. In some cases, based on the change in the radiation-sensitive material 241 after irradiation, a value representing the dose of radiation received at the surface of the test article 240 may be calculated. The amount of change in the radiation-sensitive material 241 may be proportional to the amount of radiation received at each surface. In this manner, one or more areas of interest on the surface of the target article may be determined. For example, by irradiating the target article 240 having the radiation-sensitive material 241 applied thereto, it may be determined that areas of the target article 240 that are shielded from having a line-of-sight path to the radiation source receive less radiation than other areas of the target article 240 (i.e., cold spots). As another example, if a portion of the target article is very close to the radiation source, it may be determined that the immediate portion receives more radiation than other areas of the target article 240 (ie, hot spots).

[0135] The radiation-sensitive material 241 may or may not be visible on the surface of the target article 240. In some cases, the radiation-sensitive material 241 is applied as a paint. In some cases, the radiation-sensitive material 241 is on an adhesive-backed substrate, and one or more of these "patches" are adhered to areas of interest on the surface of the target article 241. In still other cases, the radiation-sensitive material 241 is formed as dust, powder, film, dye, ink, or other substance.

[0136] In some cases, the radiation-sensitive material 241 is a silver emulsion, such as silver bromide, silver iodide, and silver sulfide. In other cases, the radiation-sensitive material 241 can be a spirooxazine-based dye dissolved in an organic solvent, such as toluene, xylene, methanol, or ethanol, or a similar substance. In these or still other cases, the radiation-sensitive material 241 can be a photochromic dye, such as 1,3,3-trimethylindolinonaphthospirooxazine, diarylethene, spiropyran, spiroperimidine, viologen, azobenzene, or other photosensitive material.

[0137] A radiation map may be generated based on the amount of radiation measured by one or more on-board sensors 130. Additionally or alternatively, a radiation map may be generated based on a calibration device within the sterilization chamber 110. The calibration device may be a type of target article 240 having one or more integrated sensors 130. In this manner, in addition to generating radiation map data, the radiation values ​​measured by the calibration device may be used to verify or calibrate values ​​measured by other sensors located within the sterilization chamber 110.

[0138] Figure 5C is a diagram of a configuration of the sterilization chamber 110 having a target article calibrating device 240a positioned within the interior volume 112. The target article calibrating device 240a is suspended from a suspension assembly 242 in Figure 5C, but in other cases the target article calibrating device 240a may be positioned, moved, placed, configured, or arranged in some other manner within the sterilization chamber.

[0139] The target article calibrating device 240a may include any number of target article sensors 130a. While only four target article sensors 130a are explicitly referenced in FIG. 5C, it is understood that each of the target article sensors 130a actually utilized in the target article calibrating device 240 is considered. Along these lines, the radiation measurements collected by each target article sensor 130a may be computationally coupled to the location on the target article calibrating device 240a at which the sensor is formed, integrated, or otherwise positioned. The radiation measurements collected by each target article sensor 130a may further be computationally coupled to a point in a sterilization cycle.

[0140] By using a target article calibration device 240a having a surface area substantially similar to the actual target article 240, a radiation map containing dense, accurate radiation information can be generated. Additionally, by tracking radiation measurements captured by the sensor 130 during a sterilization cycle while simultaneously capturing measurements from the target article sensor 130a when the target article calibration device is positioned within the chamber, an effective sterilization cycle program can be generated to achieve a suitable level of sterilization for a particular type of target article 240. The generated sterilization cycle program can then be executed in a sterilization chamber 110 containing standard target articles 240. By monitoring the data measurements captured by the sensor 130, the radiation source 120, exposure time, or both can be controlled with appropriate resolution to deliver a minimum dose of radiation to the target article 240 with substantial confidence that the desired sterilization is achieved and that the target article is not receiving additional, unwanted radiation.

[0141] 5D is a diagram of a configuration of the sterilization chamber 110 with a target article calibrating device 240a positioned off-axis within the interior volume 112. The mechanism of the suspension assembly 242 configured to change the axis of the target article calibrating device 240a is not shown for simplicity. In some cases, the target article calibrating device 240a is fixedly positioned on the suspension assembly. In other cases, the target article calibrating device 240a may be moved manually, automatically (e.g., controllably), or semi-automatically within the sterilization chamber 110. The controller 140 may command the movement of the target article calibrating device 240a in any suitable manner.

[0142] The target article calibration device 240a may be used to collect information from any number of sensors 130a, which are incorporated into the target article calibration device 240a in FIG. 5D but are not explicitly shown to avoid obscuring the illustration.

[0143] FIG. 5E is a diagram of a configuration of the sterilization chamber 110 having another target article calibrating device 240b positioned within the interior volume 112. The target article calibrating device 240b may be configured with any desired shape, configuration, material, dimensions, and any other characteristics. The target article calibrating device 240b of FIG. 5D includes any number of target article sensors 130b. The target article sensors 130b may be of any suitable type, such as those described with respect to the target article sensors 130a and sensors 130. In some cases, the target article calibrating device may include the housing of a known medical probe modified to include any number of sensors 130a.

[0144] The target article calibrating device 240b of FIG. 5E may be controlled in any number of dimensions. For example, in some embodiments, the target article calibrating device 240b may be controlled in one dimension (e.g., up and down). In these or other embodiments, the target article calibrating device 240b may be controlled in a second dimension (e.g., left and right). In these or other embodiments, the target article calibrating device 240b may be controlled in a third dimension (e.g., front and back). In these or still other embodiments, the target article calibrating device 240b may be rotationally, time-wise, or otherwise controlled. Using a target article calibrating device 240b of the type depicted in FIG. 5E, it may be operated programmatically, manually, or in some other manner, for example, as directed by a controller.

[0145] The target article sensor 130a may be of any suitable type. In embodiments of the present disclosure, the target article sensor 130a may be of the same type as the sensor 130.

[0146] Figures 6A-6C are diagrams of models for sterilization chambers at various formation levels, and may be collectively referred to herein as Figure 6.

[0147] Some models described with respect to FIG. 6 may be created via a sterilization exposure (e.g., dose) determination unit 142 (FIG. 4) stored in a memory unit of the controller 140. The controller 140 in this case may be integrated with the sterilization chamber 110, or the controller in this case may be integrated with a different sterilization system 100. Along these lines, the interior volume patterning unit 184 (FIG. 4) may be configured to generate, modify, apply, or otherwise process a three-dimensional model of the sterilization chamber. The target article patterning unit 188 may be configured to generate, modify, apply, or otherwise process a three-dimensional model of the target article to be sterilized. The radiation source patterning unit 186 may be configured to generate, modify, apply, or otherwise process the radiation emission characteristics of the radiation source.

[0148] FIG. 6A is a diagram of an initial model of a sterilization chamber 110M. The sterilization chamber model 110M includes an interior volume model 112M and multiple (e.g., one, two, four, or any number) radiation source models 120M. Other structures within the sterilization chamber, such as angles, corners, suspension assemblies, door hinges, mounting structures, and the like, may also be modeled, but these structures are not shown in FIG. 6A to simplify the drawing. The software used to create the model may be any commercially available modeling software, the details of which are not described in detail herein so as not to obscure the inventive concepts described in this disclosure. The dashed lines in FIG. 6A are intended to illustrate structures of the sterilization chamber model 110M that would otherwise be hidden behind the walls of the modeled chamber. It is understood that the sterilization system being modeled, and any of its associated structures, may have any suitable shape, size, geometry, and other characteristics.

[0149] FIG. 6B illustrates one method of forming the sterilization chamber model 110M. The sterilization chamber model 110M is formed by arranging multiple virtual polygons to cover all surfaces of the sterilization chamber model 110M or otherwise fill the entire virtual interior volume 112M of the sterilization chamber model 110M. The virtual polygons in sequence (a) through (i) of FIG. 6B are arranged as uniformly sized cubes, but in other cases, each of the virtual polygons may have any desired size, shape, dimensions, orientation, or other useful characteristics. In some cases, one or more of the virtual polygons include edges that are mathematically predictable but are not straight. Different virtual polygons may have any one or more of different sizes, shapes, dimensions, orientations, and other different characteristics. In at least some embodiments, these different virtual polygons have a "relatively small volume" and may be referred to as "voxels," which are similar to pixels in a two-dimensional (2D) environment. As used in this context in this disclosure, "relatively small" is considered to be such that the property of interest can be properly treated as constant over the spread of the difference element.

[0150] Sequences (a) through (i) of FIG. 6B illustrate a single virtual polygon (i.e., a cube) moving through the virtual disinfection chamber. The first virtual polygon in FIG. 6B(a) is formed in the top, front-left corner of the virtual interior volume 112M, while the second, third, and fourth virtual polygons in FIG. 6B(b)-FIG. 6B(d) move across the top, front row of the virtual interior volume 112M. In FIG. 6B(e) and FIG. 6B(f), a virtual polygon is formed in the second front row from the top of the virtual interior volume 112M. In FIG. 6B(g) and FIG. 6B(h), a virtual polygon is illustrated in the top, second row from the front. In FIG. 6B(i), the virtual polygon fills the entire space of the virtual interior volume 112M.

[0151] The sequence of forming and placing the virtual polygons in Figure 6B is helpful in understanding that the virtual polygons desirably cover all surfaces of the virtual sterilization chamber or otherwise fill the entire volume of the virtual sterilization chamber, but this sequence is not limiting. In other cases, different patterns or algorithms may be used to create the virtual polygons of the sterilization chamber model 110M. Alternatively, the virtual polygons may all be formed simultaneously and in a less-than-complete or even partial sequence.

[0152] The formation of the virtual polygons in FIG. 6B creates a mathematical mapping of all portions of the virtual interior volume 112M of the sterilization chamber model 110M. Such a mapping may be referred to as a three-dimensional (3D) map, a 3D model, a multidimensional model, or the like. Each virtual polygon may be correlated with adjacent polygons, nearby polygons, and other polygons with specific mathematical relationships or positions. Each virtual polygon may be associated with a computing structure that stores information about the three-dimensional space represented by the corresponding polygon. The computing structure may store, for example, size information, shape information, angle information, position information, adjacency information, composition information, light transmission information, light absorption information, other optical property information, a description of the polygon's connections or associations with other polygons, whether adjacent or in some other arrangement of interest, and other such information. In this way, to a reasonable level of computing, all openings, ridges, cracks, crevices, angles, and other characteristics of the sterilization chamber are represented in the virtual interior volume 112M of the sterilization chamber model 110M.

[0153] For the avoidance of doubt, it is further understood that the mathematical mapping of all portions of the virtual interior volume 112M of the disinfection chamber model 110M may be realized as a set of software rules or programming code representing the progression of disinfecting radiation within the disinfection chamber model 110M. The software rules may represent one or more radiation sources capable of emitting disinfecting radiation within the virtual interior volume 112M of the disinfection chamber model 110M. For each source, any number of virtual "rays" of radiation may be generated, and each of the generated virtual rays may have a set of parameters, rules, data values, formulas, or other such characteristics of behavior (i.e., transmission, progression, and termination). In at least some cases, each virtual ray is represented by an intensity value, a radial emission angle, and associated rules for virtual ray propagation, virtual ray diffusion, virtual ray absorption, virtual ray reflection, and the like. These rules for propagation, diffusion, absorption, reflection, and the like are applied when a particular virtual ray is mapped within the virtual interior volume 112M of the disinfection chamber model 110M. In some cases, the virtual light rays are reflected off surfaces of the disinfection chamber model 110M or the target article model 240M (FIG. 6C). In these or other cases, the virtual light rays are scattered, absorbed, or extinguished after traveling a determined distance.

[0154] FIG. 6C illustrates one method of forming a target article model 240M. Following the principles of the sterilization chamber model 110M of FIG. 6B, the target article model 240M is formed by arranging multiple virtual polygons to cover all sides of the target article model 240M or to otherwise fill the entire virtual volume of the target article model 240M. The virtual polygons in sequence (a) through (l) of FIG. 6C are uniformly sized cubes, but in other cases, the virtual polygons may have any desired size and shape. Different virtual polygons may have different sizes, different shapes, or different sizes and shapes. In some cases, for example, the virtual polygons are arranged as triangles, squares, n-gons, or some other shape that are arranged to virtually cover the surface of a three-dimensional object, such as a target article, a radiation source within a chamber, a chamber wall, a positioning structure (e.g., a solder, shelf, clip, or the like), a sensor, a standoff, or any other object.

[0155] Also, following the principles of forming the sterilization chamber model 110M of Figure 6B, the sequence (a) through (l) of Figure 6C illustrates how a single virtual polygon (i.e., a cube) moves through the virtual target article 240M. The sequence of virtual polygon formation and placement of Figure 6C is helpful in understanding that the virtual polygon desirably covers all surfaces of the virtual target article model 240M or otherwise fills the entire space of the virtual target article 240M, but this sequence is not limiting. Any number of different patterns or algorithms, which may be sequential, simultaneous, or in some other manner, may be used to create the virtual polygon of the target article model 240M.

[0156] Forming the virtual polygons of the target article model 240M in FIG. 6C creates a mathematical mapping of all portions of the virtual surface of the target article model 240M. In accordance with the principles of forming a three-dimensional (3D) model of the sterilization chamber described herein, the mathematical mapping of the target article may be referred to as a 3D map, a 3D model, a multidimensional model, or similar names. In some cases, voxels may be defined or otherwise employed to resolve volumes. In other cases, two-dimensional (2D) "pixels" or other such units may be employed to describe / resolve surfaces. Each virtual polygon may correlate with adjacent polygons, nearby polygons, and other polygons with specific mathematical relationships or positions. Each virtual polygon may be associated with a computing structure that stores information about the three-dimensional space represented by the corresponding polygon. The computing structure may store, for example, size information, shape information, angle information, positioning information, adjacency information, composition information, and any other such information. In this way, at a reasonable computing level, all openings, ridges, depressions, cavities, grooves, standoffs, bonds, curvatures, and other topological features of the target article model 240M are represented. In this disclosure, surface topology is described. In other contexts, local material properties, optical properties, or other properties associated with the model representation may be determined by sensing means during scanning.

[0157] Figures 7A through 7G are modeled representations of a sterilization chamber and various target articles in a number of configurations, and may be collectively referred to herein as Figure 7.

[0158] FIG. 7A illustrates a representation of radiation 122a-122d emitted from virtual radiation sources 120M into a virtual interior volume 112M of a sterilization chamber model 110M. Radiation 122a is emitted from a first radiation source 120M, radiation 122b is emitted from a second radiation source 120M, radiation 122c is emitted from a third radiation source 120M, and radiation 122d is emitted from a fourth radiation source 120M. More or fewer radiation sources 120M in similar or different locations and orientations within the sterilization chamber model 110M could also be modeled. FIG. 7A illustrates that when the radiation sources 120M are energized, each radiation source 120M operates as commanded and according to its own parameters and characteristics. The radiation emitted into the chamber is optically affected by structures within the sterilization chamber, such as walls, hangers, bases, corners, other radiation sources, and the like.

[0159] In some cases, radiation emitted into the sterilization chamber model 110M may be traced using a "ray tracing" computer program, such as OPTICSTUDIO by ZEMAX, CODE V by SYNOPSIS, or OSLO by LAMBDA RESEARCH. The ray tracing program is used to map the simulated radiation, and information from the program may be used to generate any number of radiation intensity maps. Embodiments of these radiation intensity maps formed using information from a ray tracing program may have the same or different parameters, data fields, structure, format, or the like, as radiation intensity maps created using an actual sterilization chamber and on-board radiation measurement sensors. Along these lines, embodiments of radiation intensity maps formed based on information from a ray tracing program may be adjusted with calibration values, scaling values, or the like. These adjustments may be based on radiation measured in the sterilization chamber or, alternatively, on modeled data (e.g., a model of the target article, a model of the radiation source, or the like).

[0160] FIG. 7B illustrates a modeled representation of radiation vectors 124a-124h, or "rays," formed within the hypothetical interior volume 112M of the sterilization chamber model 110M. The representation in FIG. 7B was created using a model of the hypothetical interior volume 112M of the sterilization chamber model 110M and known characteristics of the modeled radiation source 120M, which may be inferred, based on, or otherwise calculated from any number of sources, including radiation maps formed from measured radiation data (e.g., FIG. 5), ray tracing programs, or other similar sources. Support for the accuracy of the modeled radiation vectors is obtained from empirical test measurements in an actual sterilization chamber 100 operating an actual radiation source 120 and collecting actual measurements using a sensor 130 (e.g., FIG. 5). FIG. 7B shows only a small number of radiation vectors to avoid overcomplicating the drawing. It should be understood that hundreds, thousands, or even millions of radiation vectors (e.g., rays) may be modeled and their evolution history calculated as they interact with the sterilization chamber 100 and the contents therein.

[0161] 7B, a first modeled radiation vector 124a is generated and emitted from a first modeled radiation source 120M into the interior volume 112M. The first modeled radiation vector 124a is originally directed toward the top of the interior of the sterilization chamber 110M. Then, after contacting the top of the interior of the sterilization chamber 110M, the radiation vector is reflected downward toward the bottom of the sterilization chamber 110M.

[0162] A second modeled radiation vector 124b is generated and emitted from the first modeled radiation source 120M toward the center of the modeled interior volume 112M.

[0163] A third modeled radiation vector 124c is generated and emitted from the first modeled radiation source 120M. The third modeled radiation vector 124c is also emitted toward the lower center of the modeled interior volume 112M.

[0164] A fourth modeled ray vector 124d is generated and emitted from the second modeled radiation source 120M toward the center of the modeled internal volume 112M. The second modeled ray vector 124b and the fourth modeled ray vector 124d intersect closely with each other within the modeled internal volume 112M.

[0165] A fifth modeled radiation vector 124e is generated and emitted from the second modeled radiation source 120M into the interior volume 112M. The fifth modeled radiation vector 124e is originally directed toward the bottom interior of the sterilization chamber 110M. Then, after contacting the bottom interior of the sterilization chamber 110M, the fifth modeled radiation vector is reflected upward toward the top of the sterilization chamber 110M, but first passes through the center of the modeled sterilization chamber 110M.

[0166] A sixth modeled radiation vector 124f is generated and emitted from the third modeled radiation source 120M toward the center of the modeled interior volume 112M.

[0167] A seventh modeled radiation vector 124g is generated and emitted from the third modeled radiation source 120M. The seventh modeled radiation vector 124g is directed toward and reflects from the rear wall of the modeled sterilization chamber 110M. After reflecting from the rear wall, the seventh modeled radiation vector 124g is directed toward and reflects from the left wall of the modeled sterilization chamber 110M.

[0168] An eighth modeled radiation vector 124h is generated and emitted from the fourth modeled radiation source 120M toward the center of the modeled interior volume 112M.

[0169] The modeled radiation vectors 124a-124h may be modeled according to any desired characteristics of the radiation, chamber, target article, or other structure. Reflection, absorption, re-emission, and any other such factors may be appropriately modeled to specifically represent the actual radiation emitted by an actual radiation source into an actual sterilization chamber.

[0170] Figure 7C illustrates another modeled representation of radiation vectors formed within the modeled virtual interior volume 112M of the sterilization chamber model 110M. In the model of Figure 7C, a target article model 240M (Figure 6C) is virtually placed within the interior volume 112M. Additionally, to disclose the nature of the model represented in Figure 7C, the same modeled radiation vectors 124a-124h of Figure 7B are represented in a modified manner in Figure 7C.

[0171] As can be seen in Figure 7C, the first modeled radiation vector 124a no longer reaches the center of the interior volume 112M. With the target item model 240M in place, the first modeled radiation vector 124a radiates from the first modeled radiation source 120M, reflects off the top of the interior of the sterilization chamber model 110M, and strikes the top of the target item model 240M. The model records this transfer of energy to the target item model 240M. Along these lines, the second modeled radiation vector 124b radiates from the first modeled radiation source 120M and also strikes the target item model 240M. The third and sixth modeled radiation vectors 124c, 124f are unaffected by the presence of the target item model 240M. The fourth, fifth, seventh, and eighth modeled radiation vectors 124d, 124e, 124g, and 124h are affected by and strike the target article model 240M. Through modeling tens, hundreds, thousands, or even millions of vectors, the embodiments described in this disclosure can model the radiation striking the target article model 240M with substantial accuracy. In some cases, a number (e.g., thousands, hundreds of thousands, millions, etc.) of rays are “emitted” over a period of time, and the interaction history is tracked sequentially or otherwise as the rays are reflected and / or absorbed. Eventually, the simulation converges in such a way that a stable set of values, which may represent, for example, power levels, is reached for one, some, or even all configurations of interest. When this stability is deemed to have been reached, the model is determined to have been trained to adequately characterize the model of interest.

[0172] As is apparent from the description of Figures 5-7 in particular, it is shown that actual sterilization chambers having any size, shape, dimensions, internal structure, and any other characteristics can be modeled, and radiation sources can be modeled. The radiation source modeling can operate dynamically to adjust the radiation vectors in any suitable manner to simulate radiation sources having any dimensions, placement, orientation, power, aging, cleanliness (e.g., degree of soiling, representation of radiation blockage caused by contaminants or other foreign matter on the surface of the radiation source, and the like), temperature, operating duration, time within a sterilization cycle (e.g., within the first second, within the first 10 seconds, within the first 30 seconds, after 60 seconds, and the like after starting the sterilization cycle), and any other such factors. Such modeling of sterilization chambers and radiation sources can be used to create radiation intensity maps.

[0173] Additionally, as is apparent from the description of Figures 5-7, it is illustrated that any type of actual target article 240 may be modeled (i.e., target article model 240M) to model the generation of radiation impinging on the surface of the target article within the actual sterilization chamber 110. The amount of radiation absorbed may also be calculated based on the physical and optical properties of the target surface. The creation of a radiation map based on actual data collected from one or more sensors 130 and one or more target article sensors 130a, 130b, or otherwise derived, may be used to verify, validate, or otherwise adjust the radiation map generated by the model. In this manner, time-consuming, tedious, and expensive physical modeling of actual sterilization chambers and actual target articles may be avoided, expedited, or otherwise rendered more efficiently.

[0174] Target objects may have particularly small features or oddly shaped geometries where instruments with optical detectors for direct measurement of incident power and / or dose may be impractical. On the other hand, by applying the inventive approach described in this disclosure, acceptable correlation between modeled results and physical measurements can increase confidence that radiation reaching exposed surfaces of new candidate objects can be calculated with acceptable accuracy, and therefore the local dose of radiation received at each portion of the target object can also be calculated without the need for direct measurement.

[0175] FIG. 7C also illustrates a modeled foreign object 244M within the disinfection chamber model 110M. The modeled foreign object 244M may represent a surgical glove, a sterile wipe, a label, a secondary object placed in the chamber by a medical professional, or other types of foreign objects that are occasionally placed in a medical setting. While the modeled foreign object 244M does not directly affect any of the radiation vectors directly impinging on the target article model 240M, it should be apparent that the modeled foreign object 244M may have reflective, absorptive, diffusive, or other optical properties that may affect the radiation vectors 124a-124h. Thus, a modeled foreign object 244M having any size, shape, dimensions, location, orientation, and other properties may optionally be modeled.

[0176] In some cases, the actual sterilization chamber may include one or more foreign object detection sensors 132. In these embodiments, the foreign object detection sensors 132 may include any number of infrared transmitters and detectors, any number of load cells (e.g., for detecting unexpected weight due to foreign objects, non-suspended probes placed on the floor of the chamber, or the like), any number of camera devices, or the like. Such foreign object sensors may be cooperatively coupled to an embedded or remote controller 140 (FIG. 2) that executes appropriate algorithms.

[0177] 7D-7E illustrate modeled representations of radiation vectors 124a-124h formed within the imaginary interior volume 112M of the sterilization chamber model 110M when the target article model 240Ma of the target article calibration device is present. The modeled effect on the radiation vectors 124a-124h is apparent as the position and orientation of the target article model 240Ma changes.

[0178] The models of Figures 7D and 7E are representative of the embodiment of Figures 5C and 5D. By modeling the calibration articles of Figures 5C and 5D, which can measure radiation in real time within an actual sterilization chamber, the modeling of radiation vectors can be made even more accurate. That is, the programming performing the modeling can receive feedback to adjust the model of radiation measurements captured by the on-board sensors 130 and target article sensors 130a, 130b.

[0179] Figure 7F illustrates a modeled representation of the sterilization chamber model along the lines of Figure 5E. In Figure 5E, an actual target article calibrating device 240b is used to capture radiation measurements within the sterilization chamber 110. The target article calibrating device 240b can be robustly controlled to capture a substantial number of radiation data measurements in nearly every part of the sterilization chamber and in nearly every permutation of radiation source operation. In Figure 7F, the target article calibrating device 240b of Figure 5E is modeled as a target article calibrating device model 240Mb.

[0180] Figure 7G shows various exemplary models of radiation vectors formed in the sterilization chamber model 110M when a particular target article model is present. In Figure 7G(a), a target article model 240Mc is represented in a first position on the sterilization chamber model 110M, and in Figure 7G(b), the same target article model 240Mc is represented in a second position on the sterilization chamber model 110M. In Figure 7G(c), an elongated target article model 240Md is represented on the sterilization chamber model 110M, and in Figure 7G(d), an asymmetric target article model 240Me is represented on the sterilization chamber model 110M. Figure 7G illustrates that target articles having any size, dimensions, type(s) of material(s), position, orientation, shape(s), contour(s), crack(s), crevices, ridge(s), opening(s), and any other characteristic(s) can be modeled in any modeled sterilization chamber with any modeled radiation source.

[0181] 8 is a diagram showing the target article model 240M in more detail. The target article model 240M in FIG. 8 can be generated according to the principles shown in FIGS.

[0182] While the target article model 240M in FIG. 8 represents a conventional intracavity ultrasound probe, any other target article (e.g., a medical device) may be modeled in accordance with the principles and teachings of the present disclosure. The surface of the target article may have depressions, contours, cracks, crevices, openings, ridges, alignment features, connectors, or the like. The surface may be modeled to have a range of reflectance (e.g., 0-255), a range of absorption (e.g., 0-255), and a similar range of diffusion, as well as any other optical properties. The ranges may be expressed as linear or nonlinear ranges of a particular property, from a lowest useful range to a highest useful range. The units for such ranges may include any useful units associated with a particular property. For example, in some cases, the reflectance range and absorption range may be expressed as a ratio of incoming energy to outgoing (i.e., reflected or absorbed, as the case may be) energy.

[0183] 8 is formed by arranging a plurality of virtual two-dimensional (2D) polygons (e.g., a "mesh") to cover the entire virtual surface of the initial target article model 240M. The virtual polygons do not have a uniform size or shape, but each polygon may be referred to as a triangle. The virtual polygons may have any desired size and shape to form the virtual surface of the model with substantial accuracy.

[0184] 8 creates a mathematical mapping of every portion of the surface of the target article model 240M. Each virtual polygon may be correlated with adjacent polygons, nearby polygons, and other polygons with specific mathematical relationships, positions, and orientations. Each virtual polygon may be associated with one or more dedicated computing structures, shared computing structures, or computing structures with both dedicated and shared portions. The computing structures store information about the portion of the surface of the target article model 240M represented by the corresponding polygon.

[0185] The computing structure associated with any one or more polygons may store, for example, size information, shape information, angle information, positioning information, adjacency information, composition information, and any other such information. The computing structure may store information regarding how radiation affects the surface being represented. This "surface representation" information may include reflectance, absorption, diffusion, temperature, and the like. The surface representation information may also include information indicating whether the corresponding portion of the surface (i.e., the area of ​​interest) is within a hot spot, a cold spot, or a spot of uniform irradiation. A storage repository associated with an indicator of surface type (e.g., hot spot, cold spot, or spot of uniform irradiation) may also store corresponding information associated with the radiation source, the direction of the radiation, the orientation of the target article model 240M within the sterilization chamber, how "hot" a hot spot is (e.g., 0-255), how "cool" a cold spot is, etc. In this way, the "surface type indicator" information may be more accurately represented in the radiation intensity map and the generated sterilization program.

[0186] The target article model 240M of FIG. 8 identifies various regions of interest, including one hot spot 246 and one cold spot 248. The hot spot 246 may represent a single point, multiple points, or an area. Along these lines, the cold spot 248 may represent the “coolest” spot, the area at or around the “coolest” spot, multiple cold spots, or other similar points or areas. Any other number of hot spots and cold spots, or no hot spots or cold spots, may also be identified in the target article model 240M. Along these lines, any number of hot spots 246 or cold spots 248 may also be identified on the actual target article 240.

[0187] The hot spot 246 in FIG. 8 may be determined for any number of reasons. In some cases, for example, the contours of the target article model 240M and the material represented in this portion of the target article model 240M may cause focal reflections to concentrate at the hot spot 246. This hot spot may be associated with information identifying the source of radiation, the direction from which the radiation is coming, and other such factors. Accordingly, this information may be formed as a magnification, attenuation value, or similar value that represents how much the intensity of radiation increases under what conditions at the identified hot spot. This information is used when a sterilization system is modeled according to a particular sterilization chamber model 110M when the target article model 240M device is present. This information is then also used when a sterilization program is generated. In this way, when the generated sterilization program is executed by the sterilization chamber 110, a target article 240 of the type represented by the target article model 240M will be sterilized with substantial confidence that the area of ​​interest (i.e., the hot spot) was not over-irradiated beyond its minimum dose.

[0188] The cold spot 246 in FIG. 8 may be determined for any number of reasons. For example, the different contours of the target article model 240M and the material represented by this portion of the target article model 240M may result in points on the target article surface where radiation does not reach or reaches levels below the device's uniform radiation. Along these hot spot lines, the cold spot may be associated with information identifying the radiation source, the direction from which the radiation is coming, and other such factors. The cold spot information may be formatted as a magnification, an attenuation value, or expressed in some other manner, indicating how much the intensity of radiation decreases at the identified hot spot under some or all conditions. This information is used when the particular sterilization chamber model 110M and target article model 240M are analyzed. This information is then used when a sterilization program is generated. In this manner, when the generated sterilization program is executed by the sterilization chamber 110, a target article 240 of the type represented by the target article model 240M can be sterilized with substantial confidence that the area of ​​interest (i.e., the cold spot) received a sufficient minimum dose of radiation.

[0189] III. Exemplary Process 9A through 9D are data flow diagrams 900 illustrating a minimum dose determination procedure. Collectively, FIGS. 9A through 9D may be referred to as FIG. 9. The data flow diagram 900 of FIG. 9 begins in FIG. 9A and ends in FIG. 9D. The data flow diagram 900 traverses FIG. 9 via external page references "A," "B," and "C" (FIGS. 9A, 9B, and 9C) and corresponding on-page references "A," "B," and "C" (FIGS. 9B, 9C, and 9D). Nevertheless, it is understood that the acts disclosed in the data flow diagram 900 are optional and may be performed in any order. Moreover, these acts may be performed in the sterilization system 100, in a remote computing device, or in any combination of local or remote computing devices.

[0190] 9, a particular sterilization chamber 110 embodiment is shown in various operational states. The chamber may include a sensor 130 (e.g., a photodiode), a target article location device configured as a suspension assembly 242 that holds a target article 240 (e.g., a probe or target article calibration device 240a, 240b), and an exemplary cold spot 248 on the target article 240. The various states of the sterilization chamber 110 and associated "software" are illustrated alongside some of the calculations performed in generating the minimum dose.

[0191] In Figure 9, "software" is indicated by a dashed container. The software of Figure 9 may be integrated with or otherwise associated with controller 140 (Figure 1). Additionally or alternatively, the software of Figure 9, as well as the operation of other software and algorithms of the present disclosure, may be stored, executed, or stored and executed remotely from controller 140. The operation of the software of Figure 9 to determine a minimum dose will now be further described.

[0192] Execution begins at 902.

[0193] As described in this disclosure, the target article may include any number of regions of interest, such as cold spots, hot spots, and uniformly irradiable surfaces. A minimum dose calculation is developed to deliver sufficient radiation into chamber 110 to reduce the population of undesirable biological agents on the surface of the target article by a determined acceptable amount, thereby generating a total minimum dose with the understanding that radiation delivered to the cold spot of the target article is particularly relevant. Along these lines, it may be recognized that delivering a minimum dose to the "coolest" cold spot of the target article also delivers a minimum dose to each of the other cold spots on target article 240, and even to each of the other surfaces of the target. Thus, cold spot 248 in FIG. 9 may represent the "coolest" cold spot of target article 240.

[0194] Within the sterilization chamber 110, the amount of radiation measured at the sensors 130 can be used to infer or otherwise determine how much radiation is delivered to a particular area of ​​interest (e.g., cold spot 248) on the surface of the target article 240. The dose of radiation received at the surface of the target article 240 can then be estimated or inferred or otherwise determined by a calculated average of the radiation doses measured at any one of the sensors 130. Such a calculated average radiation dose can be generated by summing the doses measured at all of the sensors 130 and dividing that sum by the total number of sensors 130.

[0195] However, because it has been further determined that not all surfaces of the target article receive the full total dose of radiation, calculating the minimum dose requires more than simply determining the average radiation dose measured by sensor 130. Instead, because cold spots may receive less radiation (i.e., a lower dose) than other areas on the surface of target article 240, understanding the unitless ratio between the radiation dose received at cold spot 248 and the radiation dose received at other portions of the surface of the target article, such as the surface of sensor 130, is beneficial in generating the minimum dose.

[0196] The ratio determined in 902 may represent a factor (e.g., a scaling factor, weighting factor, or the like) that is applied to information representing the dose of radiation measured by the sensor 130 to determine that a minimum dose of radiation was applied to the cold spot of the article 240. A different ratio is typically generated for each target article 240.

[0197] By way of example, the ratio (R) determined in 902 may be understood to represent how much more radiation must be applied to the target article 240 to be sufficiently certain that all surfaces of the target article 240, including the cold spot 248, have received the minimum dose. For example, a ratio (R) of 2 may indicate that the cold spot 248 receives only half of the average radiation received by the sensor 130, a ratio (R) of, for example, 3 may indicate that the cold spot 248 receives only one-third of the average radiation received by the sensor 130, and a ratio (R) of, for example, 1.5 may indicate that the cold spot 248 receives only two-thirds of the average radiation received by the sensor 130. Other ratio values ​​may, of course, be determined.

[0198] It is also recognized that a corresponding ratio may be determined for each hot spot on the target article. In this manner, the "hottest" hot spot also has particular relevance. By understanding how much radiation is received at the hot spot, the timed exposure of the minimum amount of radiation can be tailored to avoid over-irradiating the target article 240 or to otherwise reduce the adverse effects of over-irradiation.

[0199] At 904, within the sterilization chamber 110, the dose of radiation (D) received at any number of sensors 130 may be representative of the amount of radiation (UV) received at a surface of interest on the target article 240. The ratio between the radiation dose received at the cold spot 248 and the average radiation dose received at the sensors 130 within the chamber 110 is determined as per Equation 1. Any number of sensors (n) may be considered, as determined by the particular sterilization chamber 110 of interest.

[0200]

number

[0201] At 904, in the sterilization chamber 110, D pd_1represents the dose of radiation received at the first sensor 130, and D pd_2 represents the dose of radiation received at the first sensor 130. These doses are expressed in the illustrated formula as D photodiode_1 and D photodiode_2 The radiation dose at the cold spot 248 in the disinfection chamber is expressed as D _cs In the illustrated formula, D _cs It is recognized that this simple averaging is one straightforward way to combine these detected measurements. In other cases, the values ​​read from one or more sensors may be adjusted via calibration coefficients. For example, other methods of calibration, "filtering" (e.g., applying a mathematical algorithm that can consider other factors and may include data from previous time steps, estimating values ​​from "forward-looking" predictive models, providing other corrections resulting from measured or calculated input information, etc.) may also be employed.

[0202] At 906, the concept of high-level disinfection (HLD) as introduced and described in this disclosure is recognized. Achieving HLD for a target article 240 is to provide a log reduction in viability of at least a determined amount (e.g., 10, 10, 10, or some other amount) of one or more specified microorganisms on the cold spot 248 of the target article 240. The radiation dose (D coldspot Achieving this target reduction when the radiation dose (D0) exceeds the determined threshold minimum radiation dose (D0) is expressed in Equation 2. HLD←→D coldspot ≧D0 (Formula 2) In reality, the measured radiation dose (D measured ) to the target radiation dose (D target ) to reach a determination that the HLD has been achieved. In at least one case, the target radiation dose (D target ) is mJ / cm 2The irradiance is expressed in units of . This value may be expressed as a region-specific dose, which allows for calculation of the dose to a region of a given area or extent. Additionally, this value may represent a small (i.e., a so-called "area difference factor"), medium, or large region relative to the overall extent of the target object. In these cases, it may be predicted or otherwise anticipated that the irradiance will likely not be uniform across all of the regions comprising the target article 240.

[0203] In the process of 908 of FIG. 9B, a target dose of radiation is determined. The target radiation dose (D target ) corresponds to the HLD achieved at the target cold spot 248. target ) is the minimum dose of radiation (D0) scaled by a ratio (R) and then scaled by a safety factor as shown in Equation 3.

[0204]

number

[0205] The safety factor in Equation 3 is viewed as a simple multiplication to facilitate understanding of the operation of the present invention. In other cases, the safety factor may involve application of a constant (e.g., a DC offset or "intercept"), second-order nonlinear scaling, or some other more sophisticated calculation. In these and still other cases, the safety factor may be applied to a correction that is updated in real time based on measurements.

[0206] The safety factor is configured to compensate for the effect of influence factors on the delivery of radiation to the target article 240. As described herein, an influence factor is a property, parameter, or other such element that may affect the relationship between the radiation measured by the sensor 130 and the radiation impinging on the surface of the target article 240. A non-exhaustive and non-limiting list of such factors includes the effect of repeatability and precision of optical simulation and modeling, the effect of differences in aging of individual radiation sources 120, the effect of differences in temperature of the radiation sources 120, the effect of uncertainty in placement of the target article 240 within the sterilization chamber 110, the effect of uncertainty in calibration of the reference standard including drift between multiple calibrations, the effect of uncertainty in the calibration procedure, and the like. In at least one case, the safety factor (F safety ) is estimated as the square root of the sum of the squares of each determined influence, yielding a determined confidence of 95%, plus a magnification factor of 2. This may be applied, for example, to normally distributed stochastic processes. In other cases, variables exhibiting behavior better described by other probability distributions may suggest that other calculations are appropriate.

[0207] At 910, the measured radiation dose (D measured ) is calculated using the calibration coefficient (C calib ) is quantified by applying the measured dose (D measured ) is the average dose measured by the (n) sensors 130.

[0208]

number

[0209] An exemplary calibration procedure is described in this disclosure and further described with respect to 912 and 914. This procedure uses a calibration factor (C) configured to scale the actual radiation measurements from the sensor 130 captured in the HLD procedure. calib) to generate the calibration coefficient (C calib ) accounts for variations and differences between the radiation source 120, time, temperature, aging, and other such factors. In Equation 4, the measured dose of radiation (D measured ) is the average sensor radiation dose (e.g., the cumulative radiation readings from (n) sensors 130 divided by the number of sensors (n)) multiplied by a calibration factor (C calib ) is determined by multiplying such measured radiation dose (D measured ) is the radiation dose (D) striking the cold spot 248 of the target article 240 scaled by the ratio R coldspot ), and both of these values ​​are scaled by the calibration factor.

[0210] At least one further embodiment of a calibration process for determining calibration coefficients is described at 912 and 914. Equations 7 through 10 are presented. D photodiode_1 =Signal photodiode ×Coeff_calibration_i (Equation 7) D measured =D solo (Formula 8)

[0211]

number

[0212] C calib =R solo (Formula 10)

[0213] At 912, the calibration process iterates from 1 to (n) individually to measure the radiation dose (D photodiode_n ) applied in the sterilization chamber 110 and received by each sensor 130. pd_1 , Signal pd_2) are processed individually, and the radiation dose (D photodiode_n ) is the signal of each sensor (Signal pd_1 , Signal pd_2 ) by a determined or determinable calibration coefficient (Coeff_calibration_i) (Coeff_calibration_n).

[0214] At 914, a specific calibration device target article 240a, 240b may be positioned in the sterilization chamber 110. The calibration device target article 240a, 240b may include, for example, any number of sensors 130a. In this manner, a specific dose of radiation (D solo ) can be measured and communicated electronically from the sterilization chamber 110 to the software via communication.

[0215] Also at 914, the exemplary calibration process involves calibrating the dose of radiation (D photodiode_1 , D photodiode_2 , D photodiode_n ) is the specific dose of radiation (D) delivered to the surface of the calibration device target article 240a, 240b, as shown in Equation 8. solo In some cases, the specific dose of radiation (D solo ) may represent the dose of radiation delivered to the cold spot 248. In other cases, the specific dose of radiation (D solo ) may represent the dose of radiation delivered to a hot spot, a uniformly radiating surface, or some other surface of the calibration device target article 240a, 240b. solo ) measurements are used to link the amount of radiation impacting the surface of the calibration device target articles 240a, 240b with the amount of radiation measured by each sensor 130 deployed within the target sterilization chamber 110.

[0216] The measured radiation dose (D) as shown in Equation 4 measured ) is combined with the calibration coefficients to provide the ratio (R solo It will be appreciated that the measured radiation dose (D measured ) is the specific dose of radiation (D solo ), the calibration coefficient is the ratio (R solo ) is determined to be the same as (Equation 10).

[0217] The processing at 916 and 918 in FIG. 9D uses the calibration process and other aspects of data flow 900 to determine the minimum dose (D0).

[0218] Target dose of radiation (D target ) is expressed in Equation 3. For the target dose, the safety factor (F safety ) to the minimum dose (DO) applied. As explained in this disclosure, the minimum dose (DO) represents the amount of radiation required to provide a log reduction in viability of at least a determined amount of one or more specified microorganisms on the cold spot 248 of the target article 240. Empirical testing of inoculated test carriers that are then irradiated in a sterilization chamber under test conditions can be used to determine the amount of radiation required to achieve the HLD. This test data, associated with specific pathogens on specific test carriers of known size, shape, and placement in the sterilization chamber 110, is used in conjunction with the principles of Equations 4 through 10 to determine the ratio (R) of the specific carriers. carrier ) can be determined, which then translates into the target dose (D target ) in determining the reference ratio (R ref) is used as the reference ratio (R). As mentioned above, there is a proportional relationship between the energy fluence ratio. The ratio between the test carrier and the sensor 130 measuring the radiation in the sterilization chamber 110, determined during empirical testing, is used as the reference ratio (R ref ) is used to determine R ref =R carrier (Formula 11)

[0219]

number

[0220] The measured dose (D measured ) is the average dose across all sensors as shown in Equation 13. The determined carrier ratio (R carrier ) is the measured dose (D measured ), which allows the determination of the minimum dose as shown in Equations 14 and 15.

[0221]

number

[0222] D0=R carrier ×D measured (Formula 14) D0=R carrier ×D ref (Formula 15)

[0223] Processing of data flow 900 ends at 920 .

[0224] Figures 10A-10C are dataflow diagrams illustrating the use of calculated minimum doses in some embodiments of modeled and actual devices. Figure 10A is an embodiment of dataflow 1000A that models a first sterilization chamber, models a first test article, generates a verified sterilization program, and loads it into an actual first sterilization chamber. The first chamber is then operated to sterilize the actual first test article by applying the minimum dose of generated radiation according to the sterilization program. Figure 10B is an embodiment of dataflow 1000B that models any number of sterilization chambers and any number of test articles. Dataflow 1000B communicates the generated sterilization program based on these models to any number of sterilization systems 100. Figure 10C is an embodiment of dataflow 100C that scans and models devices in a sterilization chamber in real time. A sterilization program for sterilization of the modeled device is created in real time, and the sterilization program is executed. Figures 10A-10C may be collectively referred to herein as Figure 10.

[0225] 10 is a set of data flow diagram embodiments that represent exemplary applications of the structures and acts described in this disclosure. One or more of the data flow diagrams, alone or in combination, present a set of overall structures and methods for disinfection radiation dose determination that are convolved with the characteristics and attributes of a particular disinfection system. The result of this convolution is a properly characterized and understood disinfection system that uses radiation (e.g., UV-C) as a disinfectant, intended to disinfect reprocessed target articles, such as ultrasound probes or other medical devices, to an acceptable level for high-level disinfection (HLD).

[0226] In FIG. 10A, processing begins at 1002 and continues to 1004.

[0227] At 1004, data is collected from a particular sterilization chamber. The sterilization chamber may be any type of such chamber. In at least some cases, the sterilization chamber is configured to irradiate the chamber with UV-C radiation. The process at 1004 may include "scanning" the interior volume of the sterilization chamber to capture digital data representing dimensions, angles, and other characteristics of any number of structures within the chamber. The dimensions may include data associated with radiation sources, such as the positioning of the radiation sources relative to one another within the sterilization chamber, suspension structures for target articles, sensors, reflectance and absorptance of any number of materials within the sterilization chamber, and the like. The process then proceeds to 1006.

[0228] At 1006, the data collected at 1004 is used to model a particular sterilization chamber. The processing at 1006 may be performed according to the structures and methods described in this disclosure with respect to Figures 4 through 7. The processing at 1006 is iterative. The modeling may include a feedback system to use results from previous modeling. The modeling may include data from other systems implementing data flow 1000A. That is, in some cases, the results of modeling a sterilization chamber may be shared between multiple systems over a communications network, such as the Internet.

[0229] Upon completion of processing at 1006, the particular sterilization chamber of interest has been modeled, and the emission of sterilizing radiation within the chamber has also been modeled. Processing continues at 1008.

[0230] At 1008, actual radiation data may be collected from a target article equipped with one or more sensors. In these operations, an actual test target article may be placed in an actual sterilization chamber. As the sterilization chamber operates, actual radiation data may be collected via sensors integrated with, embedded in, or otherwise associated with the test target article. This process is iterative and may include structures and methods described in this disclosure with respect to Figures 5 through 7. Processing continues to 1010.

[0231] At 1010, a particular target article is modeled. The process at 1010 may be performed according to the structures and methods described in this disclosure with respect to Figures 5 through 8. The process at 1010 is iterative, and the device modeling may follow the lines of the chamber modeling at 1006. A feedback system may use the results of previous modeling, and the results of device modeling may be shared among any number of sterilization systems.

[0232] In at least some cases, modeling the target article involves identifying any number of areas of interest (i.e., hot spots, cold spots) of non-uniform irradiation that are then addressed in developing a sterilization program to ensure that all surfaces of the target article receive a minimum dose of radiation.

[0233] Upon completion of processing at 1010, the particular target article of interest has been modeled, and the effect of the target article on the emitted sterilizing radiation within the particular sterilization chamber has also been modeled. Processing continues at 1012.

[0234] At 1012, a sterilization program is created for delivering a minimum dose of radiation to the target article. The minimum dose may be calculated as described throughout this disclosure, particularly as described with respect to FIG. 9. The sterilization program includes instructions (e.g., software) executable by a processor of a particular sterilization system. The sterilization program may include initialization acts, data collection acts, acts of collecting data from sensors, acts of controlling structures within the sterilization chamber such as radiation sources and timers, and other such acts. In at least some cases, the sterilization program is embodied as a software program executable on a computing device such as processor 140.

[0235] The sterilization program generated in 1012 is configured to deliver the minimum dose of radiation necessary to achieve a desired level of sterilization of the target article. The test article considers hot spots, cold spots, and any other similar areas (i.e., areas of interest) with uneven irradiance. During operation, the sterilization program receives and acts upon any number of measurements of accumulated radiation by sensors associated with the sterilization chamber. In at least some cases, the sterilization program does more than operate one or more radiation sources at a specified power level. The dose of radiation delivered to the test article is the integral of the power, possibly varying, delivered over the exposure time. Because the minimum dose has already been calculated and communicated to the sterilization program, the sterilization program knows what the total exposure (i.e., dose) needs to be. Therefore, the sterilization program may further operate to capture radiation measurement data from one or more sensors, and then operate the radiation source (e.g., at a constant output, intermittent output, varying power levels, or the like) until the minimum dose is achieved.

[0236] At 1012, the sterilization program may be validated in any known manner. In some cases, the sterilization program is created and empirically tested. In other cases, the operation of the sterilization program may be partially or fully simulated.

[0237] After processing at 1012, processing proceeds to 1014, where a sterilization program is configured and provided (e.g., loaded) into a particular sterilization chamber. The sterilization program is configured to control any number of radiation sources within the particular sterilization chamber to emit sterilizing radiation according to parameters determined based on a three-dimensional model of the sterilization chamber and a three-dimensional model of the sterilization target articles. Target articles of the modeled type and the type for which the sterilization program was created are loaded into the sterilization chamber. The target articles are sterilized.

[0238] At 1016, the operations of data flow 1000A may be repeated for any number of different target articles and any number of different sterilization chambers. In at least some cases, for example, a particular sterilization chamber may be configured to sterilize two or more types of target articles in a medical setting. By repeating certain acts of data flow 1000A, multiple sterilization programs may be generated, each sterilization program, or portions of a single sterilization program, may be specifically configured to sterilize each of two or more types of target articles. In this same manner, a sterilization chamber may have multiple models created to account for different assembly structures or other different configurations of the sterilization chamber. In this manner, multiple sterilization programs may be generated, each sterilization program, or portions of a single sterilization program, may be specifically configured to account for various optional configurations of the sterilization chamber.

[0239] Processing of data flow 1000A ends at 1018.

[0240] In Figure 10B, processing of data flow 1000B begins at 1020 and proceeds to 1022. The processing of data flow 1000B may, in some cases, be integrated with the processing of data flow 1000A.

[0241] At 1022, any number of sterilization chambers and any number of target articles may be modeled. The operations of data flow 1000B may be performed on a sterilization system, a remote computing server, or other computing device. In this manner, any number of databases may be created or otherwise maintained. For example, several databases may store sterilization chamber models, target article models, sterilization programs, and any parameters associated with such chambers, target articles, and algorithms. Access to such databases may be allowed for any number of local or remote sterilization systems. After all target articles and all sterilization chambers have been modeled, processing descends to 1024.

[0242] At 1024, the model data is communicatively communicated to any number of sterilization systems, remote computing devices, or other devices.

[0243] Processing from 1024 proceeds to 1026 and ends.

[0244] In FIG. 10, processing of data flow 1000C begins at 1030 and continues to 1032.

[0245] At 1032, certain types of sterilization systems include a scanning system (e.g., one or more infrared transceivers, one or more cameras, or the like). Such a system allows one or both of the sterilization chamber and the target article to be scanned and modeled "on the fly." The operations at 1032 may include operations of the present disclosure, such as those described with respect to FIG. 10A. Processing proceeds from 1032 to 1034.

[0246] At 1034, the particular sterilization system creates a sterilization program to irradiate the modeled device with a minimal dose of radiation, and the sterilization program is then run with the actual target item placed in the sterilization chamber.

[0247] Processing from 1034 continues to 1036 and ends.

[0248] Figure 11 illustrates a first exemplary process 1100 for determining sterilization exposure. Referring to Figure 11, in exemplary operation 1110, a sterilization system 100 is provided for use in sterilizing target articles 240. The sterilization system 100 includes a sterilization chamber 110 having an internal volume 112 and a radiation source 120 coupled to the internal volume 112. The radiation source 120 emits radiation, e.g., UV-C light, when in operation. Details of the sterilization system 100 are described herein with respect to Figures 1-10.

[0249] Further, in exemplary operation 1110, a target article 240 is provided. The target article 240 includes the structural configuration of the surface to be disinfected, including a surface material having material properties, including, but not limited to, heating and radiation-reflecting properties. The target article 240 may also include a classification of disinfection criteria, for example, a critical item, a semi-critical item, or a non-critical item. The target article 240 may include one or more contaminants on its surface, for example, a range of Mycobacterium species, Escherichia coli, Staphylococcus aureus, Trichophyton mentagrophyton, Pseudomonas aeruginosa, Enterococcus hirae, Bacillus subtilis, Bacillus cereus, Clostridium sporogenes, Candida albicans, orthopoxvirus, enterovirus, Adenovirus type 5, and human papillomavirus.

[0250] In an exemplary operation 1120, the internal volume patterning unit 184 identifies the structural configuration of the internal volume 112. The structural configuration may include any structurally related features of the internal volume 112 that affect the radiation intensity on the disinfection area within the internal volume 112. The structural configuration may include the size and shape of the internal volume 112, the location of the mounting mechanism 242 that holds the target article 240 within the internal volume 112, the number of radiation sources 120 attached to the internal volume 112, the locations of the radiation sources 120, the number and locations of reflectors within the internal volume 112, etc. The internal volume patterning unit 184 may identify the structural configuration of the internal volume 112 through user input, for example, via the disinfection requirement input 160, or may retrieve such information from the database 150.

[0251] In an exemplary operation 1130, the radiation source patterning unit 186 identifies radiation emission characteristics of the radiation source 120 of the sterilization system 100. The radiation emission characteristics of the radiation source 120 may include or relate to the aging of the radiation source 120 and may be time-dependent, i.e., the emitted radiation beam may change over time after the radiation source 120 is turned on for operation. The radiation emission characteristics may also include the radiation intensity of the UV-C light emitted by the radiation source 120 and the range / angle of the trajectory traveled by the radiation beam.

[0252] The radiation emission characteristics of the radiation source 120 may be characteristics received from at least the database 150 or detected by the sensor 130. For example, the actual operation of the radiation source 120 may be monitored by the sensor 130, and the monitored data may be fed back to the controller 140 to dynamically update the database 150 regarding the radiation emission characteristics of the radiation source 120.

[0253] In exemplary operation 1140, the target article patterning unit 188 identifies a surface structural configuration of the identified target article 240. As will be appreciated, the surface structural configuration may affect the radiation intensity irradiated onto the surface of the target article 240. The surface structural configuration may include the surface shape of the target article 240, including one or more of holes, depressions, protrusions, or any other physical features of the target article 240. The surface structural configuration may also include the position, alignment, orientation, or the like, of the target article 240 within the interior volume 112 under the sterilization operation. The surface structural configuration may also include parameters representing the surface material of the target article 240.

[0254] In an exemplary operation 1150, the radiation intensity map generation unit 190 generates a radiation intensity map of the interior volume 112 based on one or more of the UV-C radiation emission characteristics of the radiation source 120, the structural configuration of the interior volume 112, and the surface structural configuration of the target article 240. The radiation intensity map includes radiation intensity values ​​for each disinfection region within the interior volume 112 that are relevant to the disinfection operation of the target article 240. That is, the radiation intensity map may or may not include values ​​that actually or calculated represent all spots and all orientations within the interior volume 112 with an acceptable level of accuracy.

[0255] In some embodiments, the radiation intensity map may be generated under the assumption that target articles 240 placed within the interior volume 112 do not change the radiation intensity over the disinfection area. As such, the radiation intensity may be generated for an empty interior volume 112.

[0256] In some other embodiments, the surface structural shape and / or surface optical properties of the target article 240 may be assumed to substantially change the radiation intensity on the disinfection area within the interior volume 112. For example, the surface shape of the target article 240 may reflect the radiation, which affects the radiation intensity. The surface material of the target article 240 may affect the reflection and absorption of the radiation. Furthermore, some unique, nonlinear, or non-simple shapes of the target article 240 may affect the amount of radiation that reaches the surface portion of the target article 240. For example, it may be difficult for the radiation to reach the bottom region of a long, tubular surface portion of the target article 240.

[0257] Because the radiation emission characteristics of the radiation source 120 may be time-dependent, multiple radiation intensity maps may be generated for multiple points in time in the operating cycle of the radiation source 120. The radiation intensity maps may be generated for different operating conditions of the radiation source 120, for example, output power levels.

[0258] Exemplary operation 1150 may include sub-operation 1152 in which calibration unit 192 "calibrates" the values ​​represented in the generated radiation intensity map. In one embodiment, calibration is performed by measuring actual radiation intensities on a calibration object positioned within interior volume 112 and comparing the measured radiation intensity values ​​with the generated intensity values ​​represented in the radiation intensity map. Figure 12 illustrates exemplary details of sub-operation 1152 for calibrating the radiation intensity map.

[0259] 12 , in example operation 1153, a calibration target is positioned within the interior volume 112. The calibration target may be comparable in at least some portions to the target article 240. For example, the calibration target may include the same or similar surface structural configuration as the target article 240, including surface shape and surface material. The calibration target may be positioned within the interior volume 112 in the same manner as the target article 240. In one example, the actual sterilization operation of the target article 240 may serve the purpose of calibration. For example, monitored radiation intensity data for the actual sterilization operation of the target article is used to calibrate a radiation intensity map used for sterilization operations of other similar target articles.

[0260] The sensor may be attached directly to the calibration target at a selected portion. For example, if the target article 240 and the calibration target include special surface features that potentially affect the estimation of the radiation intensity impinging on the surface features, a sensor may be attached to such surface features to measure the actual radiation intensity impinging thereon.

[0261] In exemplary operation 1154, the radiation intensity of any number of sterilization regions attached to the calibration target and overlapping the measurement regions of sensors associated with the calibration target, including sensors attached to the interior volume 112, may be estimated or otherwise calculated based on the radiation values ​​represented in the radiation intensity map. When the calibration target is identical or substantially similar to the target article 240, the estimated radiation intensity values ​​may be retrieved directly from the radiation intensity map. When the calibration target is comparable but not identical to the target article 240, the estimated radiation intensity values ​​may be recalculated based on the radiation intensity map because the surface structure of the calibration target may affect the applied radiation intensity differently than the target article 240. In at least some of these cases, the recalculation may be based on information associated with one or more of a model of the sterilization chamber, a model of the target article, or a model of data from a ray tracing program, as described in this disclosure.

[0262] In exemplary operation 1155, with radiation source 120 operating, actual radiation intensity values ​​are measured by sensors attached to the calibration target and sensors 130 attached to interior volume 112. In one example, multiple radiation intensity values ​​are measured over time for the same disinfection area and / or the same portion of the calibration target. In this manner, time-dependent changes in radiation intensity values ​​may also be determined and used in ray tracing program models, disinfection program development, and the like, to predict or otherwise characterize the output radiation of radiation source 120.

[0263] In exemplary operation 1156, the measured radiation intensity values ​​and the estimated radiation intensity values ​​are algorithmically combined, such as by comparison.

[0264] In exemplary operation 1157, the radiation intensity values ​​represented in the radiation intensity map may be updated based on the results of operation 1156. The updates may be local to a particular disinfection area, e.g., a “touch-up” update, or may be global in the algorithm generating the radiation intensity map. More specifically, the results of the calibration procedure described in 1152 may be used to adjust the individual (i.e., local) radiation intensity values ​​represented in the radiation intensity map. Such adjustments may take into account, for example, hot spots that are measured as hotter or colder than expected, cold spots that are measured as hotter or colder than expected, or hot or cold spots that were not expected at all. Additionally or alternatively, the results of the calibration procedure may determine that all (i.e., global) radiation intensity values ​​represented in the radiation intensity map are empirically determined to be either too low or too high in calibration tests.

[0265] 11 , in an example operation 1160, the sterilization exposure determination unit 142 determines the sterilization exposure on the target article 240 based on the updated radiation intensity map. In addition to the updated radiation intensity map, the temperature response of the target article to radiation may also be considered in the sterilization exposure amount. In one example, different sterilization exposures may be determined for different portions of the target article because different portions are irradiated with different radiation intensities and have different heating characteristics. The sterilization exposure may include varying operating conditions of the radiation source 120 among different portions of the target article 240 and / or along different points in the sterilization cycle.

[0266] In the foregoing disclosure, device, system, and method embodiments illustrate and describe high-level disinfection (HLD) cycles that are performed based on one or more of a timed application of radiation into the chamber, a determined dose of radiation applied into the chamber, and a combination of the duration and determined dose of radiation applied into the chamber. In these cases, it is determined that a minimum dose of radiation is applied to the device in the chamber, and in particular, that the minimum dose of radiation is applied to at least one region of interest (e.g., a determined cold spot) on the device. This determination may be made, at least in part, using one or more sensors configured to control the radiation application means in a manner that confirms, with acceptable certainty, that the correct minimum dose is applied in the cycle.

[0267] The one or more sensors may include clock (e.g., timing) circuitry, radiation measurement (e.g., photodiode) circuitry, temperature circuitry, foreign object detection circuitry, device identification circuitry, and other such circuitry. In some cases, the one or more sensors are radiation measurement circuitry (e.g., radiation sensor circuitry) configured to capture instantaneous radiation measurements, accumulated radiation measurements over time, or some other data representative of instantaneous or accumulated radiation. Thus, using the sensors and cooperating control circuitry (e.g., processor), a determined minimum dose can be delivered. In one case, for example, the one or more sensors are configured to turn the radiation source on and off based on a length of time defining a determined irradiation cycle. In another case, the one or more sensors are configured to turn the radiation source on and off based on the accumulation of radiation until the delivery of a minimum dose is determined. In yet another case, the one or more sensors are configured to identify a device placed within the chamber, and the identification information is used, at least in part, to control the radiation source over an irradiation cycle. In yet another case, one or more sensors are configured to determine whether the device is properly placed within the chamber in a particular orientation, position, and the like, and information from such sensors is used, at least in part, to control the irradiation cycle.

[0268] Various methods, devices, and systems are described below, providing details of certain exemplary, non-limiting embodiments. Various features of the embodiments are optional, and aspects of one embodiment may be combined with other embodiments as appropriate.

[0269] Example A-1 is a method including providing a sterilization chamber having an interior volume and at least one radiation source coupled to the interior volume, the at least one radiation source configured to emit sterilizing radiation into the interior volume upon operation, determining a cold spot on a target article to be sterilized, and providing the sterilization chamber with a sterilization program configured to control the at least one radiation source to emit sterilizing radiation according to the determined cold spot. Example A-2 may include the subject matter of Example A-1 and, alternatively or in addition, any other example herein, and may further include identifying multiple regions on the target article to be sterilized, determining, within the multiple regions, an amount of sterilizing radiation to be received by each of the multiple regions over a selected period of time, comparing the amounts of sterilizing radiation to determine which region receives the least amount of sterilizing radiation, and identifying the region receiving the least amount of sterilizing radiation as the determined cold spot on the target article to be sterilized. Example A-3 may include the subject matter of any of Examples A-1 and A-2, or alternatively or in addition to any other example herein, and may further include identifying a first region of the target article that receives less sterilizing radiation than a second region of the target article. Example A-4 may include the subject matter of Example A-3, or alternatively or in addition to any other example herein, and the first region receiving less sterilizing radiation is caused, at least in part, by an interaction between the geometry of the first region and the geometry of the sterilization chamber. Example A-5 may include the subject matter of Example A-3, or alternatively or in addition to any other example herein, and the first region receiving less sterilizing radiation is caused, at least in part, by an interaction between the geometry of the first region and the geometry of the second region. Example A-6 may include the subject matter of Example A-3 and, alternatively or in addition, any other example herein, wherein the first region receiving less sterilizing radiation is caused, at least in part, by the location of the target article within the sterilization chamber.Example A-7 may include the subject matter of Example A-3 and, alternatively or in addition, any other example herein, where receiving less sterilizing radiation in the first region is caused, at least in part, by a determined value representing an amount of absorption associated with at least one of the target article and the sterilization chamber. Example A-8 may include the subject matter of Example A-3 and, alternatively or in addition, any other example herein, where receiving less sterilizing radiation in the first region is caused, at least in part, by a determined value representing an amount of reflection associated with at least one of the target article and the sterilization chamber. Example A-9 may include the subject matter of Example A-3 and, alternatively or in addition, any other example herein, where receiving less sterilizing radiation in the first region is caused, at least in part, by a determined value representing an amount of diffusion associated with at least one of the target article and the sterilization chamber. Example A-10 may include the subject matter of Example A-3 and, alternatively or in addition, any other example herein, where the first region receiving less sterilizing radiation is caused, at least in part, by the respective positions of at least one radiation source within the sterilization chamber. Example A-11 may include the subject matter of Example A-4 and, alternatively or in addition, any other example herein, and may further include modeling the geometry of the first region, modeling the geometry of the sterilization chamber, and modeling the sterilizing radiation within the sterilization chamber to determine the first and second regions. Example A-12 may include the subject matter of Example A-5 and, alternatively or in addition, any other example herein, and may further include modeling the geometry of the first region, modeling the geometry of the second region, and modeling shielding of the sterilizing radiation to the first region. Example A-13 may include the subject matter of any of Examples A-1 through A-12, and alternatively or in addition, any other example herein, and may further include providing an indication that the target article has been improperly placed in the sterilization chamber.Example A-14 may include the subject matter of any of Examples A-1 through A-12, and alternatively or in addition to any other example herein, where controlling the at least one radiation source to emit sanitizing radiation in response to the determined cold spot includes emitting the sanitizing radiation for a determined period of time. Example A-15 may include the subject matter of any of Examples A-1 through A-12, and alternatively or in addition to any other example herein, where controlling the at least one radiation source to emit sanitizing radiation in response to the determined cold spot includes determining an amount of sanitizing radiation received at a sensor instantaneously or over time, where the amount of sanitizing radiation received at the sensor instantaneously or over time indicates how much sanitizing radiation is received at the determined cold spot, and terminating the emission of the sanitizing radiation based on the determined amount of sanitizing radiation received at the sensor instantaneously or over time. Example A-16 may include the subject matter of Example A-15 and, alternatively or in addition, any other example herein, wherein determining the amount of disinfecting radiation received at the sensor includes collecting data from the sensor over time.

[0270] Example B-1 comprises a sterilization chamber having an interior volume, at least one radiation source configured to emit sterilizing radiation into the interior volume of the sterilization chamber upon operation, a target article positioning device, a memory storing a computer-generated model of a medical device of a determined type, the computer-generated model including data representing at least one physical characteristic of the medical device of the determined type, the computer-generated model including data representing at least one optical characteristic of the medical device of the determined type, the computer-generated model including data representing an area of ​​interest on a surface of the medical device of the determined type, the area of ​​interest being a first area expected to receive a different sterilizing radiation dose than a second area, and a control system configured to command operation of the at least one radiation source, wherein commanding operation includes causing the medical device of the determined type to be coupled to the target article positioning device with a determined minimum dose of sterilizing radiation. Example B-2 may include the subject matter of Example B-1 and, alternatively or in addition, any other example herein, wherein the memory stores a plurality of computer-generated models of a plurality of determined types of medical devices. Example B-3 may include the subject matter of any of Examples B-1 and B-2 and, alternatively or in addition, any other example herein, and may further include at least one radiation sensor circuit, wherein the application of the determined minimum dose of sterilizing radiation to the area of ​​interest is based on data provided by the at least one radiation sensor circuit. Example B-4 may include the subject matter of Example B-3 and, alternatively or in addition, any other example herein, wherein the at least one radiation sensor circuit comprises a photodiode. Example B-5 may include the subject matter of any of Examples B-1 through B-4 and, alternatively or in addition, any other example herein, wherein the control system is further configured to provide an indication of an improperly positioned medical device.Example B-6 may include the subject matter of any of Examples B-1 through B-5, and alternatively or in addition to any other example herein, where the region of interest is a cold spot and the at least one physical characteristic represents a topological characteristic of the determined type of medical device that prevents the sterilizing radiation from reaching the region of interest. Example B-7 may include the subject matter of any of Examples B-1 through B-5, and alternatively or in addition to any other example herein, where the control system is further configured to command the at least one radiation source to emit the sterilizing radiation for a determined time period, the determined time period being derived from a ratio of radiation irradiated to the region of interest of the determined type of medical device to radiation irradiated to at least one of another region on a surface of the determined type of medical device, the radiation sensor, and another region within the interior volume of the sterilization chamber.

[0271] Example C-1 is a non-transitory computer-readable storage medium containing executable instructions that, when executed by a processor, configure the processor to operate a sterilization system according to a method, the method including the acts of providing a sterilization chamber having an interior volume and a radiation source coupled to the interior volume, the radiation source configured, upon operation, to emit sterilizing radiation into the interior volume, and providing a sterilization program to the sterilization chamber, the sterilization program configured to control the radiation source to emit sterilizing radiation according to parameters determined based on at least one of a three-dimensional model of the sterilization chamber and a three-dimensional model of a target article to be sterilized. Example C-2 may include the subject matter of Example C-1 and, alternatively, or in addition, any other example herein, wherein the method may further include the acts of forming a three-dimensional model of the sterilization chamber by operating at least one radiation source within the data collection sterilization chamber, collecting radiation data with at least one radiation sensor, and generating, from the collected radiation data, a radiation intensity map representing a plurality of radiation intensity values ​​within a plurality of regions of the data collection sterilization chamber. Example C-3 may include the subject matter of Example C-1 and, alternatively, or in addition, any other example herein, and the method may further include the acts of forming a three-dimensional model of the sterilization chamber by providing an initial sterilization chamber model having a virtual interior volume; providing a mathematical mapping of the virtual interior volume, for example, by arranging a plurality of virtual polygons to form the mathematical mapping; generating simulated radiation information based on the mathematical mapping of the virtual interior volume using a ray tracing program; and generating a radiation intensity map from the simulated radiation information, the radiation intensity map representing a plurality of radiation intensity values ​​within a plurality of regions of the sterilization chamber.Example C-4 may include the subject matter of any of Examples C-1 through C-3 and, alternatively or in addition, any other example herein, where the method may further include the acts of forming a three-dimensional model of the target article to be sterilized by providing an initial target article model having a virtual surface, providing a mathematical mapping of the virtual surface by, for example, arranging a plurality of virtual polygons to form the mathematical mapping, and identifying at least one spot on the virtual surface of non-uniform irradiation. Example C-5 may include the subject matter of any of Examples C-1 through C-3 and, alternatively or in addition, any other example herein, where the method may further include the acts of forming a sterilization program by calculating a minimum dose of radiation to administer to the target article to be sterilized, where calculating the minimum dose includes information related to the at least one identified cold spot, applying data from the radiation intensity map to the three-dimensional model of the target article to be sterilized based on the minimum dose, and developing parameters to control the radiation source to deliver the minimum dose of radiation.

[0272] Example D-1 is a method including: providing a sterilization chamber having an interior volume and a radiation source coupled to the interior volume, the radiation source configured, upon operation, to emit sterilizing radiation into the interior volume; and providing a sterilization program to the sterilization chamber, the sterilization program configured to control the radiation source to emit sterilizing radiation according to parameters determined based on at least one of a three-dimensional model of the sterilization chamber and a three-dimensional model of a target article to be sterilized. Example D-2 may include the subject matter of Example D-1 and, alternatively, or in addition, any other example herein, and may further include forming the three-dimensional model of the sterilization chamber by operating at least one radiation source within the data collection sterilization chamber, collecting radiation data with at least one radiation sensor, and generating a radiation intensity map representing a plurality of radiation intensity values ​​within a plurality of regions of the data collection sterilization chamber from the collected radiation data. Example D-3 may include the subject matter of any of Examples D-1 and D-2, and alternatively or in addition to any other example herein, and may further include forming a three-dimensional model of the sterilization chamber by providing an initial sterilization chamber model having a virtual interior volume, providing a mathematical mapping of the virtual interior volume, for example by arranging a plurality of virtual polygons to form the mathematical mapping, generating simulated radiation information based on the mathematical mapping of the virtual interior volume using a ray tracing program, and generating a radiation intensity map from the simulated radiation information representing a plurality of radiation intensity values ​​within a plurality of regions of the sterilization chamber.Example D-4 may include the subject matter of any of Examples D-1 to D-3, and alternatively or in addition to any other example herein, and may further include forming a three-dimensional model of the target article to be sterilized by providing an initial target article model having a virtual surface, providing a mathematical mapping of the virtual surface by, for example, arranging a plurality of virtual polygons to form the mathematical mapping, and identifying at least one spot on the virtual surface of non-uniform irradiation. Example D-5 may include the subject matter of any of Examples D-1 to D-4, and alternatively or in addition to any other example herein, and may further include forming the sterilization program by calculating a minimum dose of sterilizing radiation to administer to the target article to be sterilized, the calculating the minimum dose including information related to the at least one identified cold spot, applying data from the radiation intensity map to the three-dimensional model of the target article to be sterilized based on the minimum dose, and developing parameters to control the radiation source to deliver the minimum dose of sterilizing radiation. Example D-6 may include the subject matter of any of Examples D-1 through D-5 and, alternatively or in addition, any other example herein, wherein the sterilization program is further based on a radiation intensity map, the radiation intensity map being based on at least one radiation emission characteristic of the radiation source. Example D-7 may include the subject matter of any of Examples D-1 through D-6 and, alternatively or in addition, any other example herein, and may further include positioning a calibration target within the internal volume, operating a radiation source with the calibration target within the internal volume, measuring radiation intensity values ​​on a portion of the calibration target with the radiation source operating, and updating the radiation intensity map based on the measured radiation intensity values.Example D-8 may include the subject matter of any of Examples D-1 to D-7, or alternatively or in addition to any other example herein, where the disinfection program is based on a radiation intensity map, the radiation intensity map having multiple radiation intensity values ​​for the same spot within the internal volume, each of the multiple radiation intensity values ​​being associated with a time factor for operating the radiation source. Example D-9 may include the subject matter of Example D-8, or alternatively or in addition to any other example herein, where the time factor includes aging of the radiation source. Example D-10 may include the subject matter of any of Examples D-9 to D-10, or alternatively or in addition to any other example herein, where the time factor includes a time lapse for operating the radiation source.

[0273] Example E-1 is a method. The method may be directed to modeling a determined type of medical device prior to sterilizing the determined type of medical device. The method of Example E-1 includes selecting a determined type of medical device, the determined type of medical device having a surface; creating a computer-generated model of the determined type of medical device, the computer-generated model formed as a mathematical mapping of the surface of the determined type of medical device, the computer-generated model including data representing at least one physical property of the determined type of medical device and at least one optical property of the determined type of medical device; and identifying an area of ​​interest on the surface of the determined type of medical device that is expected to receive a sterilization radiation dose of interest that differs from an overall average sterilization radiation dose. Example E-2 may include the subject matter of Example E-1 and, alternatively or in addition, any other example herein, wherein the at least one physical property represents a topological property of the target article. Example E-3 may include the subject matter of Examples E-1 and E-2, and alternatively or in addition to any other example herein, where the at least one physical property includes a value representing a depression, contour, crack, crevice, opening, ridge, alignment feature, target article positioning structure, or connector. Example E-4 may include the subject matter of Examples E-1 through E-3, and alternatively or in addition to any other example herein, where the at least one optical property includes a value representing reflection, absorption, or diffusion. Example E-5 may include the subject matter of Examples E-1 through E-4, and alternatively or in addition to any other example herein, where the at least one optical property is based on a first portion of the surface being prevented from directly receiving a sterilizing radiation dose by a second portion of the surface.Example E-6 may include the subject matter of Examples E-1 to E-5 and, alternatively or in addition, any other example herein, and wherein identifying an area of ​​interest on the surface of a medical device of a determined type includes providing a test article that is a medical device of the determined type, applying a radiation-sensitive material to the surface of the test article, irradiating the test article, and calculating a value representing the dose of disinfecting radiation received at the surface of the test article based on a change in the radiation-sensitive material after irradiation. Example E-7 may include the subject matter of Examples E-1 to E-6 and, alternatively or in addition, any other example herein, and wherein identifying an area of ​​interest on a surface of a medical device of a determined type includes providing a test article that is a medical device of the determined type; integrating at least one sensor with the test article, the at least one sensor configured to receive data representative of sterilizing radiation irradiated onto the surface of the test article; irradiating the test article; and determining from the data received by the at least one sensor that a first dose of sterilizing radiation received at a first area of ​​the test article is different from a second dose of sterilizing radiation received at a second area of ​​the test article. Example E-8 may include the subject matter of Examples E-1 through E-7, and alternatively or in addition to any other example herein, wherein identifying an area of ​​interest on a surface of a medical device of the determined type includes providing a test article that is a medical device of the determined type, integrating at least one sensor with the test article, the at least one sensor configured to receive data representative of sterilizing radiation irradiated onto the surface of the test article, irradiating the test article, and calculating a value representative of a dose of sterilizing radiation received at the surface of the test article from the data received by the at least one sensor. Example E-9 may include the subject matter of Examples E-1 through E-8, and alternatively or in addition to any other example herein, wherein the at least one radiation sensor comprises a photodiode.Example E-10 may include the subject matter of Examples E-1 through E-9, or alternatively or in addition to any other example herein, where integrating at least one sensor includes coupling the surface of the test article to the at least one sensor via a photoconductor. Example E-11 may include the subject matter of Examples E-1 through E-10, or alternatively or in addition to any other example herein, and may further include modifying the computer-generated model based on the identified region of interest. Example E-12 may include the subject matter of Examples E-1 through E-11, or alternatively or in addition to any other example herein, and may further include modifying the computer-generated model based on the determined location of the selected target article within the sterilization chamber. Example E-13 may include the subject matter of Examples E-1 through E-12, or alternatively or in addition to any other example herein, where the computer-generated model is derived from a previously formed computer-generated model, and the previously formed computer-generated model is based on a second determined type of medical device. Example E-14 may include the subject matter of Examples E-1 through E-13, and alternatively or in addition to any other example herein, and may further include generating a sterilization protocol for a selected medical device of a determined type, the selected medical device having an identified area of ​​interest on its surface, the sterilization protocol directing at least one radiation source associated with the selected sterilization chamber to irradiate the selected medical device when the selected medical device is placed in the selected sterilization chamber. Example E-15 may include the subject matter of Example E-14, and alternatively or in addition to any other example herein, and generating the sterilization protocol includes directing at least one radiation source to irradiate the selected medical device until the determined dose of sterilizing radiation is delivered to the identified area of ​​interest of the selected medical device.Example E-16 may include the subject matter of Example E-14, or alternatively or in addition to any other example herein, where generating the sterilization protocol includes directing at least one radiation source to irradiate the selected medical device until a determined dose of sterilizing radiation is delivered to at least one sensor configured within the sterilization chamber. Example E-17 may include the subject matter of Example E-14, or alternatively or in addition to any other example herein, where generating the sterilization protocol includes directing at least one radiation source to irradiate the selected medical device for a determined time period, the determined time period being derived from a ratio of radiation delivered to an identified area of ​​interest on the selected medical device and another area on a surface of the selected medical device. Example E-18 may include the subject matter of Example E-14, or alternatively or in addition to any other example herein, where generating the sterilization protocol includes modifying the sterilization protocol based on at least the determined location of the selected medical device within the sterilization chamber. Example E-19 may include the subject matter of Example E-14, or alternatively or in addition to any other example herein, where generating a sterilization protocol includes modifying the sterilization protocol based on detection of a foreign object in the sterilization chamber. Example E-20 may include the subject matter of Example E-14, or alternatively or in addition to any other example herein, where the sterilization protocol further instructs an operator of the sterilization chamber to reposition the selected medical device in the sterilization chamber based on an indication of improper placement of the selected medical device in the sterilization chamber. Example E-21 may include the subject matter of Example E-14, or alternatively or in addition to any other example herein, where the region of interest is identified based on at least one topological characteristic of the selected medical device. Example E-22 may include the subject matter of any of Examples E-1 through E-21, or alternatively or in addition to any other example herein, where the identified region of interest is a cold spot on the surface of the selected medical device.Example E-23 may include the subject matter of any of Examples E-1 through E-22, and alternatively or in addition to any other example herein, where the identified area of ​​interest is a hot spot on the surface of a selected medical device. Example E-24 may include the subject matter of any of Examples E-1 through E-23, and alternatively or in addition to any other example herein, where the computer-generated model is a three-dimensional model. Example E-25 may include the subject matter of any of Examples E-1 through E-24, and alternatively or in addition to any other example herein, where the disinfecting radiation dose is a dose of ultraviolet (UV) radiation.

[0274] Example F-1 is a method including providing a sterilization chamber having an interior volume and a radiation source coupled to the interior volume, the radiation source emitting ultraviolet C (UV-C) radiation into the interior volume when in operation; identifying a UV-C radiation emission characteristic of the radiation source; identifying a structural configuration of the interior volume; estimating a UV-C radiation intensity map within the interior volume based on the UV-C radiation emission characteristic and the structural configuration of the interior volume; and determining a disinfection dose of infected items based on the UV-C radiation intensity map. Example F-2 may include the subject matter of Example F-1 and, alternatively or in addition, any other example herein, where determining the disinfection dose includes positioning a calibration target within the internal volume, estimating a first UV-C radiation intensity value on a portion of the calibration target based on the UV-C radiation intensity map, operating a radiation source with the calibration target in the internal volume, measuring a second UV-C radiation intensity value on the portion of the calibration target with the radiation source operating, comparing the first UV-C radiation intensity value with the second UV-C radiation intensity value, updating the UV-C radiation intensity map based on the comparison result, updating the UV-C radiation intensity map based on the comparison result, and determining the disinfection dose based on the updated UV-C radiation map. Example F-3 may include the subject matter of Example F-2 and, alternatively or in addition, any other example herein, where the portion of the calibration target is comparable to a portion of an infected item with respect to receiving UV-C radiation. Example F-4 may include the subject matter of Example F-3, or alternatively or in addition to any other example herein, where the portion of the calibration target includes a comparable surface structural configuration as a portion of the infected article. Example F-5 may include the subject matter of Example F-3, or alternatively or in addition to any other example herein, where the portion of the calibration target includes a comparable surface material as a portion of the infected article.Example F-6 may include the subject matter of Example F-2, or alternatively or in addition to any other example herein, where measuring the second UV-C radiation intensity value includes measuring multiple second UV-C radiation intensity values ​​at the same spot on the portion of the calibration object over time when the calibration object is placed within the internal volume and the radiation source is operated. Example F-7 may include the subject matter of any of Examples F-1 through F-6, or alternatively or in addition to any other example herein, where the UV-C radiation intensity map includes multiple UV-C radiation intensity values ​​for the same spot within the internal volume, each of the multiple UV-C radiation intensity values ​​being associated with a time coefficient of operation of the radiation source. Example F-8 may include the subject matter of Example F-7, or alternatively or in addition to any other example herein, where the time coefficient includes aging of the radiation source. Example F-9 may include the subject matter of Example F-7, or alternatively or in addition to any other example herein, where the time coefficient includes a time coefficient of operating the radiation source. Example F-10 may include the subject matter of any of Examples F-1 through F-9, and alternatively or in addition to any other example herein, where estimating a UV-C radiation intensity map within the interior volume includes at least one of estimating a first UV-C radiation intensity map for the interior volume in an empty state and estimating a second UV-C radiation intensity map for the interior volume with an object positioned therein. Example F-11 may include the subject matter of Example F-10, and alternatively or in addition to any other example herein, where the object is at least one of an infected item or a calibration target. Example F-12 may include the subject matter of any of Examples F-1 through F-11, and alternatively or in addition to any other example herein, where determining a disinfection dose based on the UV-C radiation intensity map includes determining a dose map including a first dose for a first portion of the infected item and a second, different dose for a second portion of the infected item.Example F-13 may include the subject matter of any of Examples F-1 through F-12, and alternatively or in addition to any other example herein, wherein identifying a UV-C radiation emission characteristic of the radiation source is based on received UV-C radiation intensity data of the radiation source detected by a sensor positioned within the interior volume. Example F-14 may include the subject matter of any of Examples F-1 through F-13, and alternatively or in addition to any other example herein, wherein estimating a UV-C radiation intensity map within the interior volume includes estimating multiple UV-C radiation intensity maps based on multiple operating states of the radiation source. Example F-15 may include the subject matter of any of Examples F-1 through F-14, and alternatively or in addition to any other example herein, wherein determining a disinfection dose of the infected items includes determining a temperature response of the infected items to UV-C radiation. Example F-16 may include the subject matter of any of Examples F-1 through F-15, and alternatively or in addition to any other example herein, where determining the disinfection dose includes identifying a surface structural configuration of the infected article. Example F-17 may include the subject matter of Example F-16, and alternatively or in addition to any other example herein, where the surface structural configuration includes at least one of holes, depressions, protrusions, and locations within the interior volume.

[0275] Example G-1 is a non-transitory storage medium containing executable instructions that, when executed by a processor, configure the processor to operate a sterilization system, the instructions including: identifying a sterilization chamber having an interior volume and a radiation source coupled to the interior volume, the radiation source emitting ultraviolet-C (UV-C) radiation into the interior volume during operation; determining a UV-C radiation emission characteristic of the radiation source; receiving a structural configuration of the interior volume; receiving surface characteristics of infected articles; estimating a UV-C radiation intensity map within the interior volume based on the UV-C radiation emission characteristic, the structural configuration of the interior volume, and the surface characteristics of the infected articles; and determining a disinfection dose of the infected articles based on the UV-C radiation intensity map. Example G-2 may include the subject matter of Example G-1 and, alternatively or in addition, any other example herein, wherein determining a disinfection dose of the infected articles includes determining a minimum disinfection dose.

[0276] Example H-1 is a system comprising a sterilization chamber having an interior volume, a radiation source coupled to the interior volume, the radiation source emitting sterilizing radiation into the exterior volume when operational, and a control system configured to control the radiation source to emit the sterilizing radiation according to parameters determined based on at least one of a three-dimensional model of the sterilization chamber and a three-dimensional model of a target article to be sterilized. Example H-2 may include the subject matter of Example H-1 and, alternatively or in addition, any other example herein, wherein the three-dimensional model of the sterilization chamber is associated with a radiation intensity map created using radiation data collected by at least one radiation sensor or simulated radiation information based on a mathematical mapping of the interior volume. Example H-3 may include the subject matter of any of Examples H-1 and H-2, and alternatively or in addition to any other example herein, and further includes at least one radiation sensor configured to measure radiation emitted within the interior volume, and the control system is further configured to control the radiation source based on the measured radiation and a determined (e.g., calculated) minimum dose of radiation to administer to the target article to be sterilized. Example H-4 may include the subject matter of Example H-3, and alternatively or in addition to any other example herein, and the determined (e.g., calculated) minimum dose is based on a ratio of radiation irradiated to the at least one radiation sensor and radiation irradiated to a cold spot of the target article to be sterilized. Example H-5 may include the subject matter of any of Examples H-3 and H-4, and alternatively or in addition to any other example herein, and the determined (e.g., calculated) minimum dose is further based on a safety factor. Example H-6 may include the subject matter of any of Examples H-1 to H-5, and alternatively or in addition, any other example herein, and further includes a memory device unit that stores an internal volumetric pattern forming unit configured to generate a three-dimensional model of the sterilization chamber.Example H-7 may include the subject matter of any of Examples H-1 to H-5, and alternatively or in addition, any other example herein, and further comprises a memory device unit that stores a target article pattern formation unit configured to generate a three-dimensional model of a target article to be disinfected.

[0277] Example I-1 is a sterilization system comprising a sterilization chamber having an internal volume, a radiation source coupled to the internal volume, the radiation source emitting ultraviolet-C (UV-C) radiation into the external volume when operating, and a control system configured to identify a structural configuration of the internal volume, receive surface characteristics of infected articles, estimate a UV-C radiation intensity map within the internal volume based on the UV-C radiation emission characteristics, the structural configuration of the internal volume, and the surface characteristics of the infected articles, and determine a sterilization dose for the infected articles based on the UV-C radiation intensity map. Example I-2 may include the subject matter of Example I-1 and, alternatively or in addition, any other example herein, and further causes the control system to automatically generate a sterilization program executable within a target sterilization chamber, the sterilization program configured to provide the determined minimum radiation dose to the target medical device, and the sterilization program automatically generated based on a combination of the digital map of the exemplary sterilization chamber and the digital map of the exemplary medical device. Example I-3 may include the subject matter of Example I-1 or I-2, and alternatively or in addition to any other example herein, and further includes causing the control system to create a first digital map of the exemplary sterilization chamber. Example I-4 may include the subject matter of any of Examples I-1 through I-3, and alternatively or in addition to any other example herein, and further includes causing the control system to provide the exemplary sterilization chamber. Example I-5 may include the subject matter of any of Examples I-1 through I-4, and alternatively or in addition to any other example herein, and further includes causing the control system to provide an exemplary data collection device having multiple data collection sensors. Example I-6 may include the subject matter of any of Examples I-1 through I-5, and alternatively or in addition to any other example herein, and further includes causing the control system to operate the exemplary sterilization chamber for a determined period of time.Example I-7 may include the subject matter of any of Examples I-1 through I-6, and alternatively or in addition to any other example herein, and further includes causing the control system to collect UV-C data with a data collection sensor. Example I-8 may include the subject matter of any of Examples I-1 through I-7, and alternatively or in addition to any other example herein, and further includes causing the control system to create a digital map of the exemplary sterilization chamber. Example I-9 may include the subject matter of any of Examples I-1 through I-8, and alternatively or in addition to any other example herein, and further includes causing the control system to calibrate the sensors over time. Example I-10 may include the subject matter of any of Examples I-1 through I-9, and alternatively or in addition to any other example herein, and further includes causing the control system to create a set of virtual points representing the interior of the exemplary sterilization chamber. Example I-11 may include the subject matter of any of Examples I-1 through I-10, and alternatively or in addition to any other example herein, and further include causing the control system to generate a map of UV-C for each of the virtual points. Example I-12 may include the subject matter of any of Examples I-1 through I-11, and alternatively or in addition to any other example herein, and further include causing the control system to generate a map of UV-C vectors within an exemplary sterilization chamber. Example I-13 may include the subject matter of any of Examples I-1 through I-12, and alternatively or in addition to any other example herein, and further include causing the control system to generate a map of UV-C light source degradation. Example I-14 may include the subject matter of any of Examples I-1 through I-13, and alternatively or in addition to any other example herein, and further include causing the control system to generate a map of UV-C light sensor degradation. Example I-15 may include the subject matter of any of Examples I-1 through I-14, and alternatively or in addition, any other example herein, and further causes the control system to generate a map of shadows within the exemplary sterilization chamber.Example I-16 may include the subject matter of any of Examples I-1 through I-15, alternatively or in addition to any other example herein, and further include causing the control system to generate a map of reflection vectors within the exemplary sterilization chamber. Example I-17 may include the subject matter of any of Examples I-1 through I-16, alternatively or in addition to any other example herein, and further include causing the control system to generate a map of the sterilization area. Example I-18 may include the subject matter of any of Examples I-1 through I-17, alternatively or in addition to any other example herein, and further include causing the control system to adjust the position of an on-board detector. Example I-19 may include the subject matter of any of Examples I-1 through I-18, alternatively or in addition to any other example herein, and further include causing the control system to generate a second digital map of the exemplary medical device. Example I-20 may include the subject matter of any of Examples I-1 through I-19, alternatively or in addition to any other example herein, and further cause the control system to provide an exemplary medical device. Example I-21 may include the subject matter of any of Examples I-1 through I-20, alternatively or in addition to any other example herein, and further cause the control system to generate a digital model of the exemplary medical device. Example I-22 may include the subject matter of any of Examples I-1 through I-21, alternatively or in addition to any other example herein, and further cause the control system to create a set of virtual points representing the surface of the exemplary medical device. Example I-23 may include the subject matter of any of Examples I-1 through I-22, alternatively or in addition to any other example herein, and further cause the control system to create a model of the radiation dose to be delivered to each of the virtual points. Example I-24 may include the subject matter of any of Examples I-1 to I-23, and alternatively or in addition, any other example herein, and further causes the control system to identify a location of interest among the set of virtual points.Example I-25 may include the subject matter of any of Examples I-1 through I-24 and, alternatively or in addition, any other example herein, and further include having the control system identify hot spots, optionally based on average collected radiation data values. Example I-26 may include the subject matter of any of Examples I-1 through I-25 and, alternatively or in addition, any other example herein, and further include having the control system identify cold spots, optionally based on average collected radiation data values. Example I-27 may include the subject matter of any of Examples I-1 through I-26 and, alternatively or in addition, any other example herein, and further include modifying the disinfection program to adjust the disinfection dose to be applied to the target articles so that all locations intended for disinfection receive at least the minimum dose required for a given level of disinfection. Example I-28 may include the subject matter of any of Examples I-1 through I-27 and, alternatively or in addition, any other example herein, and further cause the control system to generate a map of blocked regions. Example I-29 may include the subject matter of any of Examples I-1 through I-28 and, alternatively or in addition, any other example herein, and further cause the control system to generate a map of absorbing regions. Example I-30 may include the subject matter of any of Examples I-1 through I-29 and, alternatively or in addition, any other example herein, and further cause the control system to collect feedback from on-board sensors and perform a calibration function based on the feedback, optionally wherein the calibration function may compare actual values ​​of data received by the on-board sensors with expected values ​​of data received by the sensors. Example I-31 may include the subject matter of any of Examples I-1 to I-30, and alternatively or in addition, any other example herein, and further includes causing the control system to algorithmically combine the first digital map and the second digital map to create a disinfection program.Example I-32 may include the subject matter of any of Examples I-1 through I-31 and, alternatively or in addition, any other example herein, and further cause the control system to generate one or more margins for misaligned or mispositioned medical devices. Example I-33 may include the subject matter of any of Examples I-1 through I-32 and, alternatively or in addition, any other example herein, and further cause the control system to load a sterilization program into a target sterilization chamber. Example I-34 may include the subject matter of any of Examples I-1 through I-33 and, alternatively or in addition, any other example herein, and further cause the control system to load a target medical device into a target sterilization chamber. Example I-35 may include the subject matter of any of Examples I-1 through I-34 and, alternatively or in addition, any other example herein, and further cause the control system to execute a sterilization program. Example I-36 may include the subject matter of any of Examples I-1 through I-35, alternatively or in addition to any other example herein, and further include causing the control system to detect a foreign object in the sterilization chamber. Example I-37 may include the subject matter of any of Examples I-1 through I-36, alternatively or in addition to any other example herein, and further include causing the control system to monitor the temperature in the sterilization chamber to be below 35°C and / or above 55°C. Example I-38 may include the subject matter of any of Examples I-1 through I-37, alternatively or in addition to any other example herein, and further include causing the sterilization radiation to be at least one of UV-A radiation, UV-B radiation, and UV-C radiation. Example I-39 may include the subject matter of any of Examples I-1 through I-38, alternatively or in addition to any other example herein, and further include causing the sterilization chamber to include a plurality of reflective surfaces.Example I-40 may include the subject matter of any of Examples I-1 to I-39, or alternatively or in addition to any other example herein, where the disinfection chamber comprises at least one hanger system that cooperatively mates with the target medical device. Example I-41 may include the subject matter of any of Examples I-1 to I-40, or alternatively or in addition to any other example herein, where the disinfection chamber comprises at least one hanger system that cooperatively positions the target medical device. Example I-42 may include the subject matter of any of Examples I-1 to I-41, or alternatively or in addition to any other example herein, where the disinfection chamber comprises at least one hanger system that cooperatively orients the target medical device. Example I-43 may include the subject matter of any of Examples I-1 to I-42, or alternatively or in addition to any other example herein, where the objects in the chamber may not be stationary during disinfection. Example I-44 may include the subject matter of any of Examples I-1 through I-43 and, alternatively or in addition, any other example herein, and further cause the control system to control one of the number, rate, and pattern of UV exposures based on a computer-generated model. Example I-45 may include the subject matter of any of Examples I-1 through I-44 and, alternatively or in addition, any other example herein, and further cause the control system to adjust the computer-generated model based on at least one of aging of the radiation source, aging of the radiation sensor, contamination, and actual measurement variation relative to the computer-generated model. Example I-46 may include the subject matter of Examples I-1 through I-44 and, alternatively or in addition, any other example herein, and further cause the control system to adjust the computer-generated model based on at least one of aging of the radiation source, aging of the radiation sensor, contamination, and actual measurement variation relative to the computer-generated model. Example I-47 may include the subject matter of any of Examples I-1 through I-45, and alternatively or in addition to any other example herein, and further cause the control system to select one of a plurality of disinfection times. Example I-47 may include the subject matter of any of Examples I-1 through I-46, and alternatively or in addition to any other example herein, and further cause the control system to extend a time in the disinfection algorithm based on not reaching a minimum dose. Example I-48 may include the subject matter of any of Examples I-1 through I-47, and alternatively or in addition to any other example herein, and further cause the control system to terminate the disinfection cycle to reduce or avoid damage to the target medical object. Example I-49 may include the subject matter of any of Examples I-1 through I-48, and alternatively or in addition to any other example herein, and further cause the control system to determine whether the target medical device has been pre-cleaned prior to disinfection. Example I-50 may include the subject matter of any of Examples I-1 through I-49, alternatively or in addition to any other example herein, and further cause the control system to execute a fully automated disinfection protocol. Example I-51 may include the subject matter of any of Examples I-1 through I-50, alternatively or in addition to any other example herein, and further cause the control system to terminate the disinfection cycle based on at least one of average or point exposure, total exposure, a combination of average or point exposure and total exposure, elapsed time, or temperature. Example I-52 may include the subject matter of any of Examples I-1 through I-51, alternatively or in addition to any other example herein, and further cause the control system to execute the disinfection cycle in at least one of less than 10 minutes, 5 minutes, 3 minutes, 90 seconds, or 60 seconds. Example I-53 may include the subject matter of any of Examples I-1 to I-52, and alternatively or in addition, any other example herein, wherein the sterilization chamber includes alignment markings for ensuring consistent placement of the test article within the sterilization chamber.Example I-54 may include the subject matter of any of Examples I-1 to I-53, and alternatively or in addition to any other example herein, wherein the sterilization chamber comprises a movable mounting assembly controlled by a control system. Example I-55 may include the subject matter of any of Examples I-1 to I-54, and alternatively or in addition to any other example herein, wherein the radiation source provides an output radiation power of at least 5 watts. Example I-56 may include the subject matter of any of Examples I-1 to I-55, and alternatively or in addition to any other example herein, wherein the radiation source is configured to provide a substantially uniform surface irradiation of the sterilization area. Example I-57 may include the subject matter of any of Examples I-1 to I-56, and alternatively or in addition to any other example herein, further causing the control system to maintain a temperature within the sterilization unit between about 35°C and about 45°C.

[0278] Having now described several embodiments, further clarification of some of the terms used herein may be helpful to a more thorough understanding of what is believed to be inventive in the present disclosure.

[0279] The computing devices described herein have electronic memory accessible by at least one processing unit within the device. The memory is programmed with software that provides instructions to one or more processing units. Some of the software modules within the memory control the operation of the computing device with respect to the generation, collection, and distribution or other use of data. In some cases, the software directs the collection of individual pieces of data, while in other cases, the software directs the collection of sets of data.

[0280] Software may include a full executable software program, a simple configuration data file, links to additional instructions, or a combination of known software types. When a computing server updates software, the update may be small or large. For example, in some cases, the computing server downloads a small configuration data file as part of the software, while in other cases, the computing server completely replaces all of the current software on the computing device with a new version. In some cases, the software, data, or software and data are encrypted, encoded, and / or compressed in some other way for reasons including security, privacy, data transfer speed, data cost, or the like.

[0281] A processing device, or “processor,” as described herein, includes a central processing unit (CPU), microprocessor, microcontroller (MCU), digital signal processor (DSP), application-specific integrated circuit (ASIC), state machine, and the like. Accordingly, a processor as described herein includes any device, system, or portion thereof that controls at least one operation, and such a device may be implemented in hardware, firmware, or software, or a combination of at least two thereof. The functionality associated with any particular processor may be centralized or distributed, whether 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, microcode, or the like. The programmed instructions may be located in internal or external memory and 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, which, when executed, performs one or more acts of the method.

[0282] As known to those skilled in the art, computing devices, including mobile computing devices, have one or more memories, each of which may include any combination of volatile and nonvolatile computer-readable media for reading and writing. Volatile computer-readable media include, for example, random access memory (RAM). Non-volatile computer-readable media include, for example, read-only memory (ROM), magnetic media such as hard disks, optical disks, flash memory devices, CD-ROMs, and the like. In some cases, a particular memory is separated into virtually or physically separate areas, such as a first memory, a second memory, a third memory, and the like. In these cases, it is understood that the different divisions of the memory may be in different devices or may be embodied in a single memory. Some or all of the memory contents may include software instructions executable by a processing device to perform one or more specific actions.

[0283] In the present disclosure, memory may be used in one configuration or another. Memory may be configured to store data. Alternatively, or in addition, memory may be a non-transitory computer-readable medium (CRM), which is configured to store instructions executable by a processor. The instructions may be stored individually or as a group of instructions in a file. The file may include functions, services, libraries, and the like. The file may include one or more computer programs or may be part of a larger computer program. Alternatively, or in addition, each file may contain data or other computational support material useful for performing the computing functions of the systems, methods, and apparatuses described in this disclosure.

[0284] 9-12 are data flow diagrams illustrating processes that may be used by embodiments of a computing device such as the sterilization system 100. In this regard, each described process may represent a module, segment, or portion of code, which includes one or more executable instructions for implementing the specified logical function(s). Also, it should be noted that in some implementations, functions noted in a process may be performed in a different order, include additional functions, be performed simultaneously, and / or be omitted.

[0285] As used herein, the term "module" refers to an electronic circuit, a processor unit (e.g., shared, dedicated, group, single-core, multi-core, or the like) operable to execute one or more software or firmware programs and memory, an application-specific integrated circuit (ASIC), combinatorial logic circuitry, or any other individual or cooperative combination of suitable components (either hardware or software) that provides the functionality described with respect to the module.

[0286] As used herein and in the claims that follow, the term "real-time" is not intended to imply instantaneous processing, transmission, receipt, or any other operation, as the case may be. Instead, the term "real-time" implies that an activity occurs over an acceptably short period of time (e.g., a microsecond or millisecond period) and that the activity may be performed in progress (e.g., measuring radiation with sensor 130, determining whether a minimum dose of radiation has been administered, and similar operations). An example of an activity that is not real-time is an activity that occurs over a long period of time (e.g., hours or days) or that occurs based on the intervention or command of a person or other activity.

[0287] When any grammatical form of the term "substantially" or "about" is used as a modifier in this disclosure and any appended claims (e.g., to modify a structure, dimension, measurement, or some other characteristic), it is understood that the characteristic may vary by up to 30%. For example, a sterilization chamber may include multiple radiation sources mounted "substantially parallel." In such a case, two radiation sources mounted exactly parallel are mounted along a "Y" axis that is normal (i.e., 90 degrees or perpendicular) to a plane or line formed by a common "X" axis and a "Z" axis. Unlike the exact precision of the term "parallel," modifying a characteristic using "substantially" or "about" allows for a variation in the particular characteristic by up to 30%.

[0288] In the foregoing description, several specific details are set forth to provide a thorough understanding of various disclosed embodiments. However, those skilled in the art will recognize 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 related to electronic and computing systems, including client and server computing systems, as well as networks, have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

[0289] Unless the context requires otherwise, throughout this specification and the following claims, the words "comprise" and "comprises" and variations thereof (such as "comprises" and "comprising") are to be interpreted in an open and inclusive sense, e.g., "including but not limited to."

[0290] References throughout this specification to "one embodiment" or "an embodiment" and variations thereof mean that a particular feature, structure, or characteristic described with respect to that embodiment is included in at least one embodiment. Thus, the appearances of the phrase "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0291] As used in this specification and the appended claims, the singular forms "a" and "the" (corresponding to the articles "a," "an," and "the") include the plural forms unless the context clearly dictates otherwise. It should also be noted that the term "or" is generally employed to include "and / or" unless the context clearly dictates otherwise.

[0292] As used herein, the words "about" or "approximately," when used in conjunction with a number, refer to any number within 1%, 5%, or 10% of the referenced number.

[0293] The headings and abstract provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.

[0294] The various embodiments described above can be combined to provide further embodiments. These and other changes can be made to the embodiments in light of the description set forth above. In general, in the following claims, the terms used should not be construed to limit 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 range of equivalents to which such claims are entitled. Accordingly, the claims are not limited by the present disclosure. [Explanation of symbols]

[0295] 10 Operating environment 100 Disinfection System 100C Data Flow 110 Disinfection Chamber 110M Disinfection Chamber 112 internal volume 112M internal volume model 120 Radiation Source 120M Radiation Source Model 122a Radiation 122b Radiation 122c radiation 122d Radiation 124a First modeled radiation vector 124b Second modeled radiation vector 124c Third Modeled Radiation Vector 124d Fourth Modeled Radiation Vector 124e Fifth Modeled Radiation Vector 124f Sixth Modeled Radiation Vector 124g Seventh Modeled Radiation Vector 124h Eighth Modeled Radiation Vector 130, 132 sensors 130a Targeted Item Sensor 130b Targeted Item Sensor 140 Controller 142 Disinfection Exposure Determination Unit 144 Disinfection Operation Control Unit 150 databases 160 Disinfection requirements input 174 processors 176 Interfacing Unit 178 Analog-to-Digital Converter (ADC) Unit 180 Storage Unit 184 Internal Volume Pattern Formation Unit 186 Radiation Source Pattern Formation Unit 188 Target Article Pattern Formation Unit 190 Radiation Intensity Map Generation Unit 192 Calibration Unit 194 Operating Unit 196 Temperature Control Unit 198 Radiation Intensity Control Unit 202 Housing 204 Side wall 206 Top 208 Doors 212 Access opening 230 Reflective surface, inner wall 240 Target article 240a Target article calibration device 240b Target article calibration device 240Ma target article model 240Mb Target Article Calibration Device Model 240Mc Target Item Model 240Md elongated target object model 240Me asymmetric target article model 241 Radiation sensitive materials 242 Suspension Assembly 244M Foreign object 246 Hotspot 248 Cold Spot 300 Bactericidal curve 308a~308f measurement values 900 Data Flow Diagram 1000A Data Flow 1000B Data Flow 1100 processes 1110 operation 1120 operation 1130 operation 1140 operation 1150 operation 1152 Partial operation 1153 operation 1154 operation 1155 operation 1156 operation 1157 operation 1160 operation

Claims

1. providing a sterilization chamber having an internal volume and at least one radiation source coupled to the internal volume, the at least one radiation source configured, upon operation, to emit sterilizing radiation into the internal volume; determining a cold spot on a target article to be sterilized; and providing a sterilization program to the sterilization chamber, the sterilization program being configured to control the at least one radiation source to emit the sterilizing radiation according to the determined cold spot; the at least one radiation source is configured to emit ultraviolet (UV) radiation capable of effecting high-level disinfection of reusable medical devices; The sterilization program is determined by calculating a minimum dose of radiation to be administered to the target object to be sterilized, wherein calculating the minimum dose includes calculating a minimum dose that includes information related to at least one identified cold spot, and creating parameters to control the radiation source to irradiate the minimum dose of radiation. method.

2. identifying a plurality of areas of the target article to be disinfected; determining, within the plurality of regions, an amount of sterilizing radiation to be received by each of the plurality of regions over a selected period of time; comparing the amounts of sterilizing radiation to determine which area receives the least amount of sterilizing radiation; and identifying the area receiving the least amount of sterilizing radiation as the determined cold spot of the target item to be sterilized.

3. 3. The method of claim 1 or 2, including identifying a first area of ​​the target article that receives less sterilizing radiation than a second area of ​​the target article.

4. 4. The method of claim 3, wherein the first region receiving less sterilizing radiation is caused, at least in part, by an interaction between the geometry of the first region and the geometry of the sterilization chamber or the second region.

5. 4. The method of claim 3, wherein the first region receiving less sterilizing radiation is caused at least in part by the location of the target article within the sterilization chamber.

6. 4. The method of claim 3, wherein the first region receiving less sterilizing radiation is caused at least in part by the location of the at least one radiation source within the sterilization chamber.

7. 7. The method of any one of claims 1 to 6, including providing an indication that the target article has been improperly placed in the sterilization chamber.

8. 8. The method of claim 1, wherein controlling the at least one radiation source to emit the sterilizing radiation in response to the determined cold spot comprises emitting the sterilizing radiation for a determined period of time.

9. Controlling the at least one radiation source to emit the sterilizing radiation in response to the determined cold spot comprises: determining an amount of sterilizing radiation received by a sensor, the amount of sterilizing radiation received by the sensor indicating how much sterilizing radiation is received at the determined cold spot; terminating emission of sterilizing radiation based on the determined amount of sterilizing radiation received by the sensor; 9. The method of claim 1, wherein determining the amount of disinfecting radiation received by the sensor comprises collecting data from the sensor over time.

10. 10. A system for implementing the method of claim 1, said system comprising: a sterilization chamber having an interior volume, and at least one radiation source configured, upon operation, to emit sterilizing radiation into the interior volume of the sterilization chamber; a target article positioning device; a memory storing a computer-generated model of a medical device of a determined type, the computer-generated model including data representing at least one physical characteristic of the medical device of the determined type, the computer-generated model including data representing at least one optical characteristic of the medical device of the determined type, the computer-generated model including data representing an area of ​​interest on a surface of the medical device of the determined type, the area of ​​interest being a first area expected to receive a different dose of sterilizing radiation than a second area; and a control system configured to command the operation of the at least one radiation source, wherein commanding the operation includes causing the medical device of the determined type to be coupled to the target article positioning device with a determined minimum dose of sterilizing radiation. A system comprising:

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