Modular optical device for a biological fluid processing system
The modular light device addresses the challenge of maintaining light source components in biological fluid treatment systems by providing a user-friendly and efficient solution for integration and replacement, ensuring uniform light delivery and reducing operational delays.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2025-11-21
- Publication Date
- 2026-03-04
AI Technical Summary
Existing biological fluid treatment systems face challenges in efficiently and cost-effectively replacing and maintaining light source components due to complex mechanical and electrical integration requirements, leading to operational delays and resource inefficiencies.
A modular light device with a housing, light source array chamber, light sensors, driver, and controller, designed for easy integration and replacement within electronic devices, ensuring uniform light delivery and operational integrity.
Facilitates efficient, uniform, and cost-effective pathogen inactivation in biological fluids by allowing easy replacement and maintenance of light source components, reducing downtime and resource expenditure.
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Figure 2026035675000001_ABST
Abstract
Description
[Technical Field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 093,722, filed October 19, 2020, the entire contents of which are incorporated herein by reference.
[0002] The present disclosure relates generally to systems, methods, and devices for treating biological fluids, including mixtures of biological fluids and photochemicals, with light, and more particularly to modular light device architectures for use in biological fluid treatment systems. [Background technology]
[0003] Systems and methods for treating biological fluids with light are well known. For example, U.S. Patent Nos. 7,459,695, 6,986,867, and 5,593,823 describe systems for treating biological fluids with light to inactivate pathogens in the biological fluid. The light is emitted within a selected wavelength range effective to inactivate pathogens in the biological fluid, particularly by photochemical inactivation of the pathogens. Other systems and methods for treating biological fluids with light can include, for example, those described in U.S. Pat. Nos. 6,843,961 (Patent Document 4), 7,829,867 (Patent Document 5), 9,320,817 (Patent Document 6), and 8,778,263 (Patent Document 7), WO2019133929A1 (Patent Document 8), and Schlenke, 2014, Transfus. Med. Hemother. 41:309-325.
[0004] For example, in the case of blood products containing platelets and plasma components and their derivatives, it is important to ensure that the blood product is pathogen-free to minimize the risk of infection to individuals receiving the blood product. Testing for the presence of pathogens in blood is limited by the pathogens available for testing and the sensitivity of the assay. As an alternative or adjunct to pathogen testing, methods based on various compounds (e.g., chemicals, photochemicals) are known in the art for inactivating pathogens to reduce the risk of transfusion-transmitted infection (e.g., as disclosed in Schlenke et al., Transfus Med Hemother, 2014, 41, 309-325 and Prowse, VoxSanguinis, 2013, 104, 183-199). Commercially available psoralen- and ultraviolet light-based photochemical pathogen inactivation systems for processing blood products include the INTERCEPT® Blood System (Cerus Corporation), which utilizes a disposable processing set and ultraviolet light irradiation device (INT-100). Blood products, such as plasma and platelets, are mixed with psoralen and amotosalen in the processing set and then irradiated with ultraviolet A light. Several different disposable processing sets can be used depending on the type of blood product being processed and the specific characteristics of those blood products, such as volume and platelet count.
[0005] Treating biological fluids with light to inactivate pathogens therein requires the uniform delivery of a precise amount (e.g., dose) of a desired type of light (e.g., ultraviolet light) throughout the biological fluid. Thus, in one or more examples, electronic devices configured to process biological fluids often include a dedicated light source component internally located within the electronic device, which can be configured to irradiate a specific amount of light onto the biological sample being processed. The dedicated light source component must be configured to irradiate a precise amount of light while maintaining many critical operational requirements for the electronic device, such as temperature, power consumption, and footprint. Therefore, the architecture and layout of the dedicated light source component are important to ensure that the light source component can meet the requirements necessary to effectively inactivate pathogens in biological fluids. For example, it may be necessary to irradiate the biological fluid with a specific amount of ultraviolet light (e.g., in combination with a pathogen-inactivating compound) for a certain time and intensity to ensure that the UV light can effectively crosslink the pathogen's nucleic acid, rendering the pathogen inactive. Thus, the light source component must be designed to meet the requirements necessary for pathogen inactivation while also meeting other design requirements necessary to ensure that the overall electronic device is commercially viable.
[0006] Given the precise specifications to which light source components must operate, and the need to replace them (possibly multiple times during the life of the processing device), there is an unmet need to package light source components so that they can operate to precise electrical and mechanical requirements, while also providing a modular design that allows for easy replacement of the light device as needed. [Prior art documents] [Patent documents]
[0007] [Patent Document 1] U.S. Patent No. 7,459,695 [Patent Document 2] U.S. Patent No. 6,986,867 [Patent Document 3] U.S. Patent No. 5,593,823 [Patent Document 4] U.S. Patent No. 6,843,961 [Patent Document 5] U.S. Patent No. 7,829,867 [Patent Document 6] U.S. Patent No. 9,320,817 [Patent Document 7] U.S. Patent No. 8,778,263 [Patent Document 8] International Publication No. 2019 / 133929 Summary of the Invention [Means for solving the problem]
[0008] Designing a light source component of an electronic processing device to meet specific requirements can present many challenges. For example, requirements placed on the light source component may require that the light source component not only include a light source used to illuminate a sample, such as a biological fluid, but also various sensors, electrical controls, and safety features necessary to safely operate other light source components according to specifications. During the lifetime of the electronic device, the performance of the light source component may degrade due to light source attenuation and / or burnout of the light source (e.g., a light-emitting diode (LED)), the light source's life expectancy, or other unintended operating circumstances that render the light source component insufficient for its intended purpose. However, while the light source component may not be operating according to its requirements, the rest of the electronic device may be operating normally. Therefore, simply replacing the entire electronic device is not cost-effective; instead, it is more practical to simply replace one or more failed components of the light source. However, accessing individual components of the light source can be complicated and an inefficient use of resources. Instead of replacing a single component of the light source, one option is to simply replace the entire light device. However, if the optical device is integrated into an electronic device and removal becomes difficult or requires significant time and resources, each time a component of the optical device fails, the customer or user of the device may experience significant delays in restoring the device to operating condition or expend significant resources on repairs. Furthermore, replacing a light source component may require complex mechanical and electrical procedures to ensure that the replacement light source component operates in conjunction with the other components of the device when installed. However, if replacing a light source component requires complex procedures, simply replacing the light source component may not be cost-effective if the light source component fails or is otherwise unsuitable for use with a processing device.
[0009] In some embodiments, the present disclosure provides a modular light device for use in combination with an electronic device (e.g., electronic processing device) for processing biological fluids, the modular light device including a plurality of components collectively configured to transmit light to one or more biological fluids for processing, the modular light device including: a housing configured to house one or more components of the modular light device; a light source array chamber configured to transmit light (e.g., ultraviolet (UV) light of a selected wavelength (e.g., peak wavelength)), the light source array chamber including one or more light source arrays, each configured to generate UV light; and The modular light device includes one or more light sensors configured to detect (e.g., measure) light; a window portion (e.g., a window opening, a transparent window, a transmissive window) disposed on (i.e., on or in) the modular light device configured to pass UV light generated by the multiple light sources through one or more biological fluids for treatment; a driver (e.g., a light source driver) communicatively coupled to one or more components of the modular light device (e.g., a light source array chamber of the modular light device) and configured to operate the one or more components; and a controller communicatively coupled to the driver (e.g., the light source driver) and configured to operate the driver (e.g., the light source driver).
[0010] In some embodiments, the modular light device light source array chamber comprises one or more temperature sensors configured to measure a temperature (eg, of the light device).
[0011] In some embodiments, each light source of the plurality of light sources emits light having a full width half maximum (FWHM) spectral bandwidth of less than 20 nanometers.
[0012] In some embodiments, each light source of the plurality of light sources is a light emitting diode (LED).
[0013] In some embodiments, each of the one or more light source arrays comprises a respective first light source channel configured to emit ultraviolet light having a first peak wavelength of the array.
[0014] In some embodiments, the electronic device comprises a processing chamber configured to receive (e.g., hold, transport) at least one of one or more biological fluids (e.g., for processing).
[0015] In some embodiments, the modular light device is configured to be disposed within an electronic device to transmit light to one or more biological fluids within a processing chamber of the electronic device.
[0016] In some embodiments, the housing is configured to mechanically interface with the electronic device to mechanically secure the modular light device when placed within the electronic device, hi some embodiments, the housing comprises one or more tracks configured to mechanically interface with one or more rails of the electronic device to mechanically secure the modular light device when placed within the electronic device.
[0017] In some embodiments, the one or more tracks are configured to allow slidable movement of the modular light device for removal and insertion into the electronic device.
[0018] In some embodiments, the modular light device comprises one or more heat exchangers configured to transfer heat away from the light source array and / or the modular light device.
[0019] In some embodiments, the one or more heat exchangers are fin-shaped.
[0020] In some embodiments, the one or more heat exchangers are configured to exchange heat with air passing (e.g., blown, moving) through the one or more heat exchangers to move heat away from the light source array and / or modular light device.
[0021] In some embodiments, the one or more heat exchangers are configured to exchange heat with air drawn across the one or more heat exchangers by one or more fans disposed within the electronic device.
[0022] In some embodiments, the light device comprises one or more fans configured to pass (e.g., blow, pull, move) air across the one or more heat exchangers to remove heat transferred by the one or more heat exchangers.
[0023] In some embodiments, the window portion is an opening in the modular light device (eg, an opening in the housing of the modular light device, an opening to the light source array chamber of the modular light device).
[0024] In some embodiments, the window portion comprises a window material that covers or surrounds an opening in the modular light device (e.g., an opening in the housing of the modular light device, an opening to the light source array chamber of the modular light device).
[0025] In some embodiments, the window portion (eg, the window material) is made of glass.
[0026] In some embodiments, the window portion (eg, the window material) is made of a polymeric material (eg, plastic).
[0027] In some embodiments, the window portion is at least 80% transparent to UV light of a selected wavelength.
[0028] In some embodiments, the window portion is at least 90% transparent to UV light of a selected wavelength.
[0029] In some embodiments, the modular light device comprises one or more light sensors disposed in the window portion and configured to detect (e.g., measure) light generated by the modular light device (e.g., by one or more light source arrays of the modular light device, by one or more light sources of the modular light device).
[0030] In some embodiments, the modular light device includes one or more circuits (e.g., flexible circuits) disposed on (e.g., over or (at least partially across)) the window portion, and the one or more circuits (e.g., flexible circuits) comprise one or more light sensors disposed on the circuits (e.g., flexible circuits) and configured to detect (e.g., measure) light generated by the modular light device (e.g., by one or more light source arrays of the modular light device, by one or more light sources of the modular light device).
[0031] In some embodiments, the light source array chamber includes a plurality of reflector panels disposed along one or more edges of the light source array chamber.
[0032] In some embodiments, multiple reflector panels are positioned within the light source array chamber to minimize loss of light energy around the light source array chamber.
[0033] In some embodiments, one or more light sensors of the light source array chamber are oriented to detect (e.g., measure) light generated by a separate modular light device (e.g., positioned on the light source array and detecting (e.g., measuring) light generated by another modular light device).
[0034] In some embodiments, the one or more light sensors are implemented using photodiodes.
[0035] In some embodiments, one or more temperature sensors are implemented using thermistors.
[0036] In some embodiments, one or more of the one or more temperature sensors are configured to measure a temperature at a junction between a light source of the one or more light sources and a printed circuit board (PCB) on which the light sources are disposed (of the light source array).
[0037] In some embodiments, the multiple light sources are configured to generate UV-A light.
[0038] In some embodiments, the plurality of light sources are configured to generate light having a first peak wavelength of about 315 nm to about 350 nm. In some embodiments, the plurality of light sources are configured to generate light having a first peak wavelength of about 315 nm to about 335 nm. In some embodiments, the plurality of light sources are configured to generate light having a first peak wavelength of about 320 nm to about 330 nm. In some embodiments, the plurality of light sources are configured to generate light having a first peak wavelength of about 330 nm to about 350 nm. In some embodiments, the plurality of light sources are configured to generate light having a first peak wavelength of about 340 nm to about 350 nm. In some embodiments, the plurality of light sources are configured to generate light having a first peak wavelength within a range of about 345 nm ± 5 nm.
[0039] In some embodiments, the multiple light sources are configured to generate UV-B or UV-C light.
[0040] In some embodiments, the array of one or more light sources each includes a respective second light source channel configured to emit ultraviolet light having a second peak wavelength of the array, the second peak wavelength differing from the first peak wavelength by at least 5 nanometers.
[0041] In some embodiments, the array of one or more light sources each comprises a respective first light source channel configured to emit ultraviolet light having a first peak wavelength of the array in the UV-A spectrum, and a respective second light source channel configured to emit ultraviolet light having a second peak wavelength of the array in the UV-B or UV-C spectrum.
[0042] In some embodiments, the housing comprises one or more electronic interfaces configured to communicatively couple the modular light device to an electronic device.
[0043] In some embodiments, the one or more electronic interfaces include an interlock connection configured to allow the electronic device to turn off the modular light device.
[0044] In some embodiments, the one or more electronic interfaces include a communication port configured to allow the electronic device to send commands to the modular light device and to allow the modular light device to send data to the electronic device.
[0045] In some embodiments, the one or more electronic interfaces include a power port configured to transfer power from the electronic device to the modular light device.
[0046] In some embodiments, some of the light sources of the light source array chamber are configured to provide (e.g., transmit) a predetermined irradiance (e.g., density) of light to one or more biological fluids.
[0047] In some embodiments, one or more light sources of the light source array chamber collectively generate a substantially uniform dose (e.g., amount) of light (e.g., at the surface of the biological fluid, at a plane within the volume of the biological fluid, within the irradiance, transmitted from the modular light device). In some embodiments, one or more light sources of the light source array chamber collectively generate a substantially uniform irradiance (e.g., transmitted from the modular light device, within the irradiance at or on the surface of the biological fluid (e.g., a container containing the biological fluid)). In some embodiments, the variation in irradiance of light across the surface of the biological fluid is less than 25%. In some embodiments, one or more light sources of the light source array chamber generate a substantially uniform dose (e.g., amount) of light (e.g., at the surface of the biological fluid, at a plane within the volume of the biological fluid, within the irradiance). 2 The areas are collectively irradiated with less than a 25% variation (averaged over the surface area) from the integrated irradiance over the entire biological fluid (eg, container containing the biological fluid) blocking surface.
[0048] In some embodiments, one or more light sources of the light source array chamber are LEDs configured to have a beam angle (e.g., beam width) of about 110 degrees to about 130 degrees. In some embodiments, one or more light sources of the light source array chamber are LEDs configured to have a beam angle (e.g., beam width) of about 120 degrees.
[0049] In some embodiments, the dose irradiated to the biological fluid from the modular light device during the treatment process is based (e.g., based in part, at least in part) on light detected (e.g., measured) by one or more of the one or more light sensors.
[0050] In some embodiments, the amount of time the modular light device is active (e.g., emitting light) during the treatment process is based (e.g., based in part, at least in part) on light detected (e.g., measured) by one or more of the one or more light sensors. In some embodiments, the amount of time the modular light device is active is the amount of time one or more light sources are active (emitting light). In some embodiments, the amount of time the modular light device is active is the amount of time one or more light sources are activated in each cycle (e.g., pulse width modulation cycle) of pulse width modulation. In some embodiments, the amount of time the modular light device is active is the cumulative amount of time one or more light sources are activated by pulse width modulation during the treatment process.
[0051] In some embodiments, the intensity of light generated by the modular light device during a treatment process is based on (e.g., based in part, at least in part on) light detected (e.g., measured) by one or more of the one or more light sensors. In some embodiments, the intensity of light generated by the modular light device during a treatment process can be a function of pulse width modulation applied to one or more light sources (e.g., based on light detected by one or more of the one or more light sensors).
[0052] In some embodiments, an electronic device for treating a biological fluid includes a first modular light device oriented (e.g., within a processing chamber of the electronic device) to face the biological fluid to be treated, the first modular light device being oriented to transmit (configure to transmit) light (e.g., deliver an amount or dose of light, deliver a predetermined or specified amount or dose of light) to the biological fluid for treatment. In some embodiments, an electronic device for treating a biological fluid includes a first modular light device and a second modular light device (e.g., within a processing chamber of the electronic device), the first and second modular light devices being oriented to face each other (e.g., positioned each toward the biological fluid to be treated), and the first and second modular light devices collectively irradiate light onto the biological fluid for treatment. In some embodiments, the biological fluid includes (e.g., is mixed with) a photochemical compound (e.g., a pathogen inactivation compound).
[0053] In some embodiments, the first and second light devices are configured to perform a test (e.g., an operational test, an integrity test, a health test), where the test includes transmitting light from the first modular light device, detecting (e.g., measuring) the light transmitted by the first device with one or more light sensors of the second modular light device, and determining whether one or more occlusions (e.g., obstructions, obstructions) are present or absent in the light transmitted by the first modular light device by comparing the detected light to a predetermined amount of light (e.g., comparing to a baseline amount of light, comparing to determine a reduction (e.g., partial reduction, blockage) of light compared to a predetermined level). In some embodiments, the test further includes determining a baseline amount of light transmitted by the first modular light device (e.g., transmitted to the second modular light device). In some embodiments, the test further includes calibrating the first modular light device to establish a baseline amount of light transmitted by the first modular light device.
[0054] In some embodiments, the test further includes transmitting light from the second modular light device, detecting (e.g., measuring) the light transmitted by the second modular light device with one or more light sensors of the first modular light device, and determining whether one or more occlusions (e.g., obstructions, obstructions) are present or absent in the light transmitted by the second modular light device by comparing the detected light to a predetermined light level (e.g., comparing to a baseline amount of light, comparing to determine a reduction (e.g., partial reduction, blockage) of light compared to the predetermined level). In some embodiments, the test further includes determining a baseline amount of light transmitted by the second modular light device (e.g., transmitted to the first modular light device). In some embodiments, the test further includes calibrating the second modular light device to establish a baseline amount of light transmitted by the second modular light device.
[0055] In some embodiments, the test is to determine the presence of an obstructed light path within the electronic device (e.g., a scratch or foreign object (e.g., dust) on the window of a modular light engine or the platform / tray of the electronic device).
[0056] In some embodiments, the test is a test to determine the presence of a biological sample performed within the electronic device.
[0057] In some embodiments, the modular light device is configured to perform a test (e.g., an operational test, an integrity test, a health test) that includes transmitting light from one or more light source arrays in a light source array chamber of the modular light device, detecting the light transmitted by the one or more light source arrays by one or more light sensors of the modular light device (e.g., in the light source array chamber of the modular light device), and comparing the detected light to a predetermined amount of light (e.g., to determine a decrease / change in light compared to the predetermined amount). In some embodiments, the one or more light sensors are light sensors located in a window portion of the modular light device (e.g., located in circuitry located in the window portion).
[0058] In some embodiments, the test further comprises comparing the detected light to a predetermined amount of light.
[0059] In some embodiments, the testing further includes determining the integrity (e.g., functional integrity, health state, operational state) of one or more (e.g., each) of the one or more sensors (e.g., by comparing them to each other, to a baseline or standard).
[0060] In some embodiments, the testing further includes determining the integrity (e.g., functional integrity, health state, operational state) of one or more (e.g., each) light source of one or more light source arrays (e.g., by comparing with each other, or by comparing with a baseline or standard).
[0061] In some embodiments, the modular light device is configured to perform a calibration process, which includes transmitting light from one or more light source arrays of the modular light device, detecting the light transmitted by the light source array(s) of the modular light device with one or more light sensors of a calibration device (e.g., a radiometer) external to the modular light device, where the calibration device is located within the electronic device, comparing the detected light to a predetermined amount of light, and adjusting (e.g., adjusting the intensity) one or more light sources of the light source array(s). In some embodiments, adjusting (e.g., adjusting the intensity) one or more light sources of the light source array(s) is by adjusting individual light sources. In some embodiments, adjusting (e.g., adjusting the intensity) one or more light sources of the light source array(s) is by adjusting a light source channel. In some embodiments, adjusting (e.g., adjusting the intensity) one or more light sources of the light source array(s) is by adjusting the light source array.
[0062] In another aspect of the present disclosure, a method for treating a biological fluid includes providing a biological fluid and illuminating the biological fluid with one or more modular light devices described in any one of the above embodiments for a duration and intensity sufficient to inactivate pathogens in the biological fluid.
[0063] In some embodiments, a method for treating a biological fluid includes providing a biological fluid mixed with a pathogen inactivation compound, illuminating the biological fluid with one or more modular light devices described in any one of the above embodiments for a duration and intensity sufficient to inactivate pathogens in the biological fluid. The present invention provides, for example, the following. (Item 1) 1. A modular light device for use in combination with an electronic device for treating a biological fluid, the modular light device comprising a plurality of components collectively configured to transmit light to one or more biological fluids for treatment, the modular light device comprising: a housing configured to house one or more components of the modular light device; A light source array chamber configured to transmit light, the light source array chamber comprising: one or more light source arrays including a plurality of light sources each configured to generate UV light; and the light source array chamber including one or more light sensors configured to detect light; a window portion configured to pass UV light generated by the plurality of light sources through the one or more biological fluids for treatment; a driver communicatively coupled to one or more components of the modular light device and configured to operate the one or more components. (Item 2) Item 10. The modular light device of item 1, wherein the light source array chamber comprises one or more temperature sensors configured to measure temperature. (Item 3) 3. The modular optical device of claim 1, wherein each light source of the plurality of light sources emits light having a full width at half maximum (FWHM) spectral bandwidth of less than 20 nanometers. (Item 4) 4. The modular light device according to any one of items 1 to 3, wherein each light source of the plurality of light sources is a light emitting diode (LED). (Item 5) 5. The modular light device of any one of items 1 to 4, wherein each of the one or more light source arrays comprises a respective first light source channel configured to emit ultraviolet light having a first peak wavelength of the array. (Item 6) 6. The modular optical device of any one of items 1 to 5, wherein the electronic device comprises a processing chamber configured to receive at least one of the one or more biological fluids. (Item 7) 7. The modular light device of any one of items 1 to 6, wherein the modular light device is configured to be placed within an electronic device to transmit light to one or more biological fluids within the processing chamber of the electronic device. (Item 8) 8. The modular light device of any one of items 1 to 7, wherein the housing comprises one or more tracks configured to mechanically interface with one or more rails of the electronic device so as to mechanically secure the modular light device when placed within the electronic device. (Item 9) Item 9. The modular light device of item 8, wherein the one or more tracks are configured to allow slidable movement of the modular light device for removal and insertion into an electronic device. (Item 10) 10. The modular light device of any one of items 1 to 9, wherein the modular light device comprises one or more heat exchangers configured to transfer heat away from the light source array and / or the modular light device. (Item 11) Item 11. The modular light device of item 10, wherein the one or more heat exchangers are configured to exchange heat with air passing through the one or more heat exchangers to transfer heat from the light source array and / or the modular light device. (Item 12) 12. The modular light device of any one of items 10 to 11, wherein the one or more heat exchangers are configured to exchange heat with air passing through the one or more heat exchangers from one or more fans of the electronic device. (Item 13) 13. The modular light device of any one of items 1 to 12, wherein the window portion comprises a window material that covers or surrounds an opening of the modular light device, the window material being made of glass. (Item 14) 13. The modular light device of any one of items 1 to 12, wherein the window portion comprises a window material covering or surrounding an opening of the modular light device, the window material being made of a polymeric material. (Item 15) Item 15. The modular light device of any one of items 1 to 14, wherein the window portion is at least 80% transparent to UV light of a selected wavelength. (Item 16) 16. The modular device of any one of items 1 to 15, wherein the modular light device comprises one or more light sensors arranged on the one or more light source arrays. (Item 17) 17. The modular light device of any one of items 1 to 16, wherein the modular light device comprises one or more light sensors disposed in the window portion and configured to detect light generated by the modular light device. (Item 18) Item 18. The modular light device of any one of items 1 to 17, wherein the modular light device comprises one or more circuits disposed in the window portion, the one or more circuits comprising one or more light sensors disposed in the circuits and configured to detect light generated by the modular lighting device. (Item 19) Item 19. The modular light device of any one of items 1 to 18, wherein the light source array chamber includes a plurality of reflector panels arranged along one or more edges of the light source array chamber. (Item 20) 20. The modular light device of claim 19, wherein the plurality of reflector panels are positioned within the light source array chamber to minimize loss of light energy around the light source array chamber. (Item 21) 21. The modular light device of any one of items 1 to 20, wherein the one or more light sensors of the light source array chamber are oriented to detect light generated by a separate modular light device. (Item 22) Item 22. The modular light device of any one of items 1 to 21, wherein the one or more light sensors are implemented using photodiodes. (Item 23) Item 23. The modular light device of any one of items 1 to 22, wherein the one or more temperature sensors are implemented using thermistors. (Item 24) 24. The modular light device of any one of items 1 to 23, wherein one or more of the one or more temperature sensors is configured to measure a temperature at a junction between one light source of the one or more light sources and a printed circuit board (PCB) on which the light source is disposed. (Item 25) 25. The modular light device of any one of items 1 to 24, wherein the plurality of light sources are configured to generate UV-A light. (Item 26) Item 26. The modular light device of item 25, wherein the plurality of light sources are configured to generate light having a first peak wavelength of about 315 nm to about 350 nm. (Item 27) 25. The modular light device of any one of items 1 to 24, wherein the plurality of light sources are configured to generate UV-B or UV-C light. (Item 28) 28. The modular light device of any one of items 5 to 27, wherein the array of one or more light sources each includes a respective second light source channel configured to emit ultraviolet light having a second peak wavelength of the array, the second peak wavelength differing from the first peak wavelength by at least 5 nanometers. (Item 29) Item 29. The modular light device of item 28, wherein the one or more arrays of light sources each comprise a respective first light source channel configured to emit ultraviolet light having a first peak wavelength of the array in the UV-A spectrum, and a respective second light source channel configured to emit ultraviolet light having a second peak wavelength of the array in the UV-B or UV-C spectrum. (Item 30) 30. The modular light device of any one of items 1 to 29, wherein the housing comprises one or more electronic interfaces configured to communicatively couple the modular light device to the electronic device. (Item 31) Item 31. The modular light device of item 30, wherein the one or more electronic interfaces include an interlock connection configured to allow the electronic device to turn off the modular light device. (Item 32) Item 31. The modular light device of item 30, wherein the one or more electronic interfaces comprise a communication port configured to enable the electronic device to send commands to the modular light device and to enable the modular light device to send data to the electronic device. (Item 33) Item 31. The modular light device of item 30, wherein the one or more electronic interfaces include a power port configured to transfer power from the electronic device to the modular light device. (Item 34) 34. The modular light device of any one of items 1 to 33, wherein some of the light sources of the light source array chamber are configured to provide a predetermined irradiance of light to the one or more biological fluids. (Item 35) 35. The modular light device of any one of items 1 to 34, wherein the one or more light sources of the light source array chamber collectively generate light such that the irradiance of the light is substantially uniform at the surface of the biological fluid. (Item 36) Item 36. The modular light device of item 35, wherein the variation in irradiance of the light across the surface of the biological fluid is less than 25%. (Item 37) 37. The modular light device of any one of items 1 to 36, wherein the one or more light sources of the light source array chamber are LEDs configured to have a beam angle of about 110 degrees to about 130 degrees. (Item 38) Item 38. The modular light device of any one of items 1 to 37, wherein a dose applied to a biological fluid from the modular light device during a treatment process is based on light detected by one or more of the one or more light sensors. (Item 39) Item 39. The modular light device of any one of items 1-38, wherein the amount of time the modular light device is activated during a treatment process is based on light detected by one or more of the one or more light sensors. (Item 40) Item 40. The modular light device of any one of items 1 to 39, wherein the intensity of light generated by the modular light device during a treatment process is based on light detected by one or more of the one or more light sensors. (Item 41) 41. The modular light device of any one of items 1 to 40, wherein the electronic device for processing a biological fluid comprises a first modular light device oriented to face the biological fluid to be processed, the first modular light device irradiating light onto the biological sample for processing. (Item 42) 42. The modular light device of any one of items 1 to 41, wherein the electronic device for treating a biological fluid comprises a first modular light device and a second modular light device, the first and second modular light devices being oriented facing each other, and the first and second modular light devices collectively irradiate light onto the biological fluid for treatment. (Item 43) The first and second optical devices are configured to perform a test, the test comprising: transmitting light from the first modular light device; detecting the light transmitted from the first device by one or more light sensors of the second modular light device; and Item 43. The modular light device of item 42, comprising determining the presence or absence of one or more occlusions in the light transmitted by the first modular light device by comparing the detected light with a predetermined amount of light. (Item 44) The test transmitting light from the second modular light device; detecting the light transmitted from the second modular light device by one or more light sensors of the first modular light device; and Item 44. The modular light device of item 43, further comprising: determining the presence or absence of one or more occlusions to the light transmitted by the second modular light device by comparing the detected light with a predetermined light level. (Item 45) The test Item 45. The modular light device of item 43 or 44, further comprising determining a baseline amount of light transmitted by the first modular light device to the second modular light device. (Item 46) Item 46. The modular optical device of any one of items 43 to 45, wherein the test is a test to determine the presence of an obstructed optical path within the electronic device. (Item 47) 46. The modular optical device of any one of items 43 to 45, wherein the test is a test to determine the presence of a biological fluid being processed within the electronic device. (Item 48) The modular optical device is configured to perform a test, the test comprising: transmitting light from one or more light source arrays in the light source array chamber of the modular light device; 48. The modular light device of any one of items 17 to 47, further comprising detecting the light transmitted by the one or more light source arrays by one or more light sensors of the modular light device. (Item 49) Item 49. The modular light device of item 48, wherein the one or more light sensors are light sensors located in the window portion of the modular light device. (Item 50) The test 50. The modular light device of claim 48 or 49, further comprising comparing the detected light to a predetermined amount of light. (Item 51) The test a) determining the integrity of one or more of the one or more sensors; a) determining the integrity of one or more light sources of said one or more light source arrays; (Item 52) The modular light device is configured to perform a calibration process, the process comprising: transmitting light from one or more light source arrays of said modular light device; receiving data from a calibration device disposed within the electronic device, the calibration device configured to detect the light transmitted by the light source array(s) of the modular light device with one or more light sensors of the calibration device; comparing the received data with a predetermined amount of light; and 52. The modular light device of any one of items 1 to 51, comprising: adjusting an intensity of one or more light sources of the light source array(s) based on the comparison. (Item 53) 1. A method for treating a biological fluid, comprising: providing said biological fluid; and 53. The method of claim 1, further comprising illuminating the biological fluid with one or more modular light devices of any one of items 1 to 52 for a duration and intensity sufficient to inactivate pathogens in the biological fluid. (Item 54) 1. A method for treating a biological fluid, comprising: providing said biological fluid in admixture with a pathogen inactivating compound; and 53. The method of claim 1, further comprising irradiating the biological fluid with one or more modular light devices of any one of items 1 to 52 for a duration and intensity sufficient to inactivate pathogens in the biological fluid. [Brief explanation of the drawings]
[0064] [Figure 1] 1 illustrates an exemplary apparatus for treating a biological fluid according to an embodiment of the present disclosure. [Figure 2] 2 shows another exemplary diagram of the apparatus described with respect to FIG. 1 for treating biological fluids according to an embodiment of the present disclosure. [Figure 3] 1 shows another exemplary diagram for treating a biological fluid according to an embodiment of the present disclosure. [Figure 4] 1 shows an exemplary process diagram of a system for treating biological fluids according to an embodiment of the present disclosure. [Figure 5] 1 is a perspective view of an exemplary system for treating a biological fluid according to an embodiment of the present disclosure. [Figure 6] 1 is a perspective view of an exemplary system for treating a biological fluid according to an embodiment of the present disclosure. [Figure 7] 1 shows a perspective view of an exemplary system for treating biological fluids according to an embodiment of the present disclosure. [Figure 8A] 1 shows a perspective view of an exemplary system for treating biological fluids according to an embodiment of the present disclosure. [Figure 8B] 1 shows a perspective view of an exemplary system for treating biological fluids according to an embodiment of the present disclosure. [Figure 9]1 illustrates an exemplary internal hardware layout of a system for treating biological fluids according to an embodiment of the present disclosure. [Figure 10] 1 illustrates an exemplary modular optical device for use in a system for treating a biological fluid system according to an embodiment of the present disclosure. [Figure 11] 1 illustrates an exemplary modular optical device for use in a system for treating a biological fluid system according to an embodiment of the present disclosure. [Figure 12] 1 illustrates a side view of an exemplary modular optical device for use in a system for treating a biological fluid system according to an embodiment of the present disclosure. [Figure 13] 1 illustrates a bottom view of an exemplary modular optical device for use in a system for treating a biological fluid system according to an embodiment of the present disclosure. [Figure 14] 1 illustrates an exemplary thermal management structure for implementing a modular optical device for use in a system for treating a biological fluid system according to an embodiment of the present disclosure. [Figure 15A] 1 illustrates another view of an exemplary internal hardware layout of a system for treating biological fluids according to an embodiment of the present disclosure. [Figure 15B] 1 illustrates another view of an exemplary modular optical device for use in a system for treating a biological fluid system according to an embodiment of the present disclosure. [Figure 16] 1 illustrates a modular optical device testing process according to an embodiment of the present disclosure. [Figure 17A] 1 illustrates an exemplary calibration process according to an embodiment of the present disclosure. [Figure 17B] 10 illustrates another exemplary calibration process according to an embodiment of the present disclosure. [Figure 18] 1 shows an exemplary system diagram of an illumination system for treating biological fluids according to an embodiment of the present disclosure. [Figure 19] 1 illustrates another exemplary system diagram of an illumination system for treating biological fluids according to an embodiment of the present disclosure. [Figure 20]1 shows an exemplary system diagram of a system for treating biological fluids according to an embodiment of the present disclosure. [Figure 21] 1 illustrates an example implementation of a domain-specific communication protocol according to an embodiment of the present disclosure. [Figure 22] 1 illustrates an exemplary method of operating an exemplary system for treating a biological fluid according to an embodiment of the present disclosure. [Figure 23] 1 illustrates an example of a computing device according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION
[0065] The following description sets forth example methods, parameters, etc. However, it should be recognized that such description is not intended to limit the scope of the present disclosure, but is instead provided as a description of example embodiments.
[0066] In the following detailed description and embodiments of the present disclosure, reference is made to the accompanying drawings, which show, by way of illustration, specific embodiments which may be practiced. It is to be understood that other embodiments and examples may be practiced and changes may be made without departing from the scope of the present disclosure.
[0067] Furthermore, as used in the following description, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. As used herein, the term "and / or" should also be understood to refer to and include any and all possible combinations of one or more of the associated listed items. It should be further understood that the terms "includes," "including," "comprises," and / or "comprising," as used herein, specify the presence of stated features, integers, steps, operations, elements, components, and / or units, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, units, and / or groups thereof.
[0068] Some portions of the detailed description that follows are presented in terms of algorithms and symbolic representations of operations on data bits within a computer memory. These algorithmic descriptions and representations are the means used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. An algorithm is here, and generally, conceived to be a self-consistent sequence of steps (instructions) leading to a desired result. These steps require physical manipulations of physical quantities. Usually, though not necessarily, these quantities take the form of electrical, magnetic, or optical signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It is sometimes convenient, principally for reasons of common usage, to refer to these signals as "bits," "values," "elements," "symbols," "characters," "terms," "numbers," or the like. Further, it is also convenient at times to refer to particular arrangements of steps requiring physical manipulations of physical quantities as modules or code devices, without loss of generality.
[0069] However, these and similar words and phrases are associated with the appropriate physical quantities and are merely convenient labels applied to these quantities. Unless otherwise noted, and as will be apparent from the discussion that follows, throughout the description, discussions using terms such as "processing," "operating," "calculating," "determining," and "displaying" refer to the operations and processes of a computer system or similar electronic computing device that manipulate and transform data represented as physical (electronic) quantities in the computer system's memory or registers or other information storage, transmission, or display devices.
[0070] Certain aspects of the present invention may include process steps and instructions described herein in the form of an algorithm. It should be noted that the process steps and instructions of the present invention may be embodied in software, firmware, or hardware, and if embodied in software, may be downloaded to reside on and operate from different platforms for use by a variety of operating systems.
[0071] FIG. 1 illustrates an exemplary system 100 for processing biological fluids. As used herein, "biological fluid" refers to any fluid containing one or more components (e.g., biological agents) found in or derived from an organism (e.g., human, animal, plant, microorganism), or found in, isolated from, or derived from an organism (including synthetic (e.g., mutant) versions thereof). Biological fluids can include, but are not limited to, blood and blood products, vaccines, cells (e.g., primary cells, cell lines, cell cultures), natural and recombinant peptides or proteins (e.g., therapeutic drugs, antibodies), bacterial cultures, viral suspensions, and the like. As used herein, "blood product" refers to blood (e.g., whole blood), or components or derivatives of blood, such as, by way of example, red blood cells, white blood cells, platelets, plasma, or components thereof (e.g., clotting factors, albumin, fibrinogen), cryoprecipitate, and cryo-depleted (e.g., cryo-reduced) plasma, or combinations of one or more of such components separated from blood. In one or more embodiments, the biological fluid may further include a non-biological fluid, such as a physiological solution (e.g., a dilute solution), including, by way of example, but not limited to, saline, a buffer solution, a nutrient solution, a platelet additive solution (PAS), and / or an anticoagulant solvent solution. In one or more embodiments, when the biological fluid is placed within a chamber (not shown) of a biological fluid processing system (e.g., the biological fluid is in a container such as a processing bag placed on or held on a platform), the biological fluid is illuminated with light (e.g., visible light, ultraviolet light) having a particular spectral profile at a specified intensity for a predetermined period of time.
[0072] System 100 includes a power switch 110, a display 120, a scanner 130, a platform 140, and a platform 150. Although system 100 in FIG. 1 includes the described elements, embodiments of system 100 may include different combinations of the described elements or additional elements without departing from the scope of the disclosure. In some embodiments, system 100 may be coupled to a computing device (e.g., a computer, a mobile device) (not shown) via a wired or wireless connection.
[0073] In some embodiments, power is provided to system 100 in response to an input to power switch 110. For example, power switch 110 can be a mechanical button. When system 100 is off, power is provided to system 100 (e.g., system 100 is turned on) in response to pressing power switch 110. When system 100 is on, power provided to system 100 is stopped (e.g., system 100 is turned off) in response to pressing power switch 110. In some examples, system 100 remains on during processing and is not turned off in response to pressing the power switch.
[0074] As another example, power switch 110 can be a capacitive switch that can be activated by touch input (e.g., by placing a user's finger on the power switch). As yet another example, the power switch can be a button with two or more states. When the power switch is in a first position (e.g., not pressed, flipped to a first side), the power switch can be in an "off" state. When the power switch is in a second position (e.g., not pressed, flipped to a second side), the power switch can be in an "on" state.
[0075] In some examples, display 120 is a touchscreen. For example, display 120 can be a capacitive touchscreen or a resistive touchscreen. In some examples, display 120 is configured to display a graphical user interface (GUI) for operating system 100. In some embodiments, display 120 is configured to receive input from scanner 130. In one or more examples, display 120 is configured to receive input on the GUI. For example, a GUI object among multiple GUI objects displayed on the GUI can be selected by a user providing manual input (e.g., touch input or hover input) on the touchscreen. In response to receiving the input, system 100 can perform an operation associated with the selected GUI object. For example, the GUI object can be associated with initiating biological fluid processing, and in response to receiving input selecting the GUI object, system 100 can initiate a process for processing the biological fluid. In one or more examples, display 120 is configured to display instructions (e.g., operator instructions) to a user operator on the GUI. In some embodiments, display 120 is configured to display input from scanner 130 to a user operator. In some embodiments, display 120 is configured to display input from sounds that are detected by audio input (e.g., one or more microphones) and processed (e.g., speech-to-text conversion) by one or more processors into a visual form (e.g., command text, command code) on display 120 that can be recognized by the user as an input command, such as a user's voice command that is detected by one or more microphones (e.g., positioned in any configuration inside, outside, and / or part of the external housing of system 100) and converted by one or more processors into command text on display 120 that can be recognized by the user as an input command.In some embodiments, display 120 is configured to display input from user visual movements that are detected by a movement sensor (e.g., one or more cameras) and processed (e.g., movement-to-text conversion, movement-to-graphic conversion) by one or more processors into visual forms (e.g., command text, command codes, command icons, command graphics) on display 120 that can be recognized by the user as input commands, such as user hand gestures (e.g., swiping hand movements) that are detected by one or more cameras (e.g., positioned in any configuration on the interior, exterior, and / or part of the exterior housing of system 100) and converted by one or more processors into visual command text or visual graphics on display 120 that can be recognized by the user as input commands. While one display 120 is shown in FIG. 1 , system 100 can include multiple displays in some examples.
[0076] The use of a touchscreen as an input component and / or input from scanner 130 can simplify the user interface of system 100. For example, the use of a touchscreen can reduce the need for physical buttons that correspond to functions that can also be performed using the touchscreen. Biological fluid processing using system 100 can be more efficient with a simplified user interface.
[0077] Although power switch 110 and display 120 are described as elements of system 100 that can be configured to receive user input, other elements or input means can be included in system 100 without departing from the scope of this disclosure. For example, system 100 can include directional input keys, a mouse pad, or a scroll wheel configured to navigate a GUI displayed on display 120. In some embodiments, system 100 is configured to receive user input from sounds that are detected by audio input (e.g., one or more microphones) and processed (e.g., speech-to-text conversion) by one or more processors into a linguistic form (e.g., command text, command code) that system 100 can recognize as an input command, such as a user's voice command that is detected by one or more microphones (e.g., positioned in any configuration on the interior, exterior, and / or part of the exterior housing of system 100) and converted by one or more processors into command text that system 100 can recognize as an input command. In some embodiments, system 100 is configured to receive input from a user's visual movements that are detected by a movement sensor (e.g., one or more microphones) and processed (e.g., speech-to-text conversion) by one or more processors into linguistic form (e.g., command text, command codes), such as a user's hand gestures that are detected by one or more microphones (e.g., positioned in any configuration inside, outside, and / or part of the external housing of system 100) and converted by one or more processors into command text that system 100 can recognize as an input command. Alternatively or additionally, system 100 can be configured to receive inputs other than user inputs, such as from one or more sensors implemented for system 100.Non-limiting examples of various sensors that may be implemented (e.g., within the processing chamber, along with the light source component) include one or more optical sensors configured to measure light intensity in various portions of the processing chamber and / or light intensity incident on various portions of the one or more biological fluids, one or more airflow sensors, one or more thermal sensors for measuring the temperature of the processing chamber and / or the temperature of the one or more biological fluids, one or more sensors for detecting the presence and / or type of one or more biological fluids (e.g., pressure sensors, optical retroreflective sensors, optical transmission sensors, label readers, scanners, barcode scanners, RFID sensors, etc.), one or more sensors for detecting properties (e.g., transparency) of the biological fluid (e.g., optical sensors, spectroscopic sensors), one or more sensors for detecting photochemical compounds in the biological fluid (e.g., fluorescence spectroscopy), and one or more sensors (e.g., ultrasonic sensors) positioned to detect the fluid depth of portions (e.g., various portions) of the one or more biological fluids.
[0078] In some embodiments, system 100 may be configured to receive input from one or more scanners implemented for system 100. In some embodiments, scanner 130 is configured to acquire information related to the biological fluid. In some examples, scanner 130 may be configured to acquire identification information related to the biological fluid being processed. For example, the biological fluid may be stored in a container (e.g., a blood-compatible bag, a processing bag) (not shown), and that container or other containers in a multiple container assembly (e.g., a disposable fluid processing set) may include a tag or label or designated area containing some form of identification information, such as in visible form (e.g., a barcode, a QR code, etc.) and / or in transmissible form (e.g., an electronic identifier, a radio frequency identification (RFID)). In some examples, the identification information may represent information about the biological fluid, such as biological parameters or other parameters (e.g., donation ID, product code, set code, lot number, type of biological fluid, volume of biological fluid, contents of the biological fluid, e.g., platelet count), and processing parameters. In some embodiments, the biological or other parameters may optionally be combined with input from one or more sensors and / or user input to determine processing parameters. In some, multiple sets of identifying information may be obtained. For example, multiple sets of identifying information may be located on one or more respective containers associated with the biological fluid (e.g., containing or part of a multiple container assembly that contains the biological fluid), and a set of identifying information may be obtained from each respective container by scanner 130.In some examples, the scanner can be a multi-scan scanner (e.g., a camera with multi-scan capabilities, a camera in conjunction with circuitry (e.g., hardware and / or software) having multi-scan processing capabilities, a handheld scanner with multi-scan capabilities, a handheld scanner in conjunction with circuitry (e.g., hardware and / or software) having multi-scan processing capabilities, a label reader with multi-scan capabilities, a label reader in conjunction with circuitry (e.g., hardware and / or software) having multi-scan processing capabilities) that sequentially or substantially simultaneously scans multiple sets of identification information (e.g., multiple barcodes, multiple QR Codes, multiple labels, optical character recognition (OCR) of different strings or configurations of alphanumeric text and / or symbols, image recognition, etc.) disposed on one or more containers. The camera may be configured to capture (e.g., obtain), for example, multiple sets of identifying information in a "batch" mode (e.g., in response to a single user input or a single device input that commands, triggers, or otherwise initiates a multi-scan operation that obtains multiple sets of identifying information). A single multi-scan operation may capture multiple sets of identifying information sequentially or substantially simultaneously (e.g., simultaneously). (E.g., in a single operation, the camera may capture one or more images of one or more labels indicating multiple parameters of a biological product, such as, for example, donation ID, product code, set code, lot number, type of biological fluid, volume of biological fluid, contents of biological fluid, and in a single operation, the multi-scanner may perform one or more scans of the one or more labels indicating the above multiple parameters.)In some embodiments, the multi-scanner or system 100 is configured to recognize (and / or convert into another format recognized by the multi-scanner or system 100) multiple sets of captured identification information (e.g., barcodes, QR codes, alphanumeric text and / or symbols, images) captured in a multi-scan operation. After capturing the multiple sets of identification information (e.g., in the captured image(s), in the performed scan(s)), the multi-scanner can transmit or communicate them to the system 100 (e.g., via a wired or wireless connection) in a recognized (and / or converted) format (e.g., a linguistic format that the system 100 can already recognize, for example, as parameter data) or in an unrecognized format (e.g., the captured image(s), the performed scan(s)). If in an unrecognized format, the system 100 can process the captured multiple sets of identification information into a recognized format. When displaying the GUI of a processing chamber associated with a biological fluid to be processed, the system 100 can assign multiple sets of identifying information to corresponding fields (e.g., auto-fill information fields) of the GUI on the display 120. Thus, a multi-scan operation can provide for data entry of all or most parameter data of a biological fluid into multiple specific data fields via a convenient, efficient, and time-saving auto-fill technique. For example, with a multi-scan operation, a user need not perform multiple scans in a specific order to capture multiple sets of identifying information that may be presented in a specific order (e.g., a scan need not be performed for each label on a container in the visual order of the specific data fields presented to the user on the GUI).
[0079] In some examples, the identifying information can come into the field of view of the scanner 130, and the scanner 130 can acquire the identifying information when the information is within the field of view. For example, a user can hold a biological fluid processing container (e.g., a bag) with a barcode facing the scanner 130, and the scanner 130 can image, scan, or read the barcode, and based on the resulting barcode, the system 100 can determine information about the biological fluid product. In some examples, the identifying information can come into the detection range of the scanner 130, and the scanner 130 can acquire the identifying information when the information is within the detection range. For example, a user can hold a biological fluid processing bag with an RFID tag near the scanner 130, and the scanner 130 can detect the RFID tag, and based on the information obtained from the detected RFID tag, the system 100 can determine information about the biological fluid product.
[0080] 1 as being located external to system 100, scanner 130 may be located in different locations within system 100. In one or more embodiments, scanner 130 is located inside system 100. For example, scanner 130 may be located above a processing chamber of system 100. Scanner 130 may obtain information related to the biological fluid after it has been placed on the platform and / or within the chamber.
[0081] In some examples, scanner 130 may be included in a device coupled to system 100. For example, scanner 130 may be included in a handheld scanner (e.g., a barcode scanner, a QR code scanner) coupled to system 100. In some embodiments, scanner 130 couples to system 100 via a wired connection. In some embodiments, scanner 130 couples to system 100 via a wireless connection.
[0082] Although one scanner 130 is shown in FIG. 1 , system 100 can include multiple scanners 130. For example, system 100 can include multiple processing chambers, each of which may have a corresponding scanner (e.g., an internal scanner). As another example, system 100 can include multiple platforms, each of which may have a corresponding scanner (e.g., an external scanner) positioned near or at the opening of the respective platform. As the platform moves through the opening, a container (e.g., a processing bag) containing the biological fluid can cross the field of view of each scanner, and information associated with the biological fluid can be acquired by each scanner in visible form on the container or a container of an associated dual container assembly. As another example, system 100 can include both a first scanner integrated with the system (e.g., located external to system 100 and within a processing chamber of system 100) and a second scanner (e.g., a handheld scanner) coupled to system 100.
[0083] In some examples, the platform 140 (e.g., a drawer, tray, well, plate, stage) is configured to hold a biological fluid (e.g., in a vessel containing the biological fluid) during processing. In some examples, the platform is movable between the interior and exterior of the processing chamber (e.g., slidably movable and configured to translate from inside the processing chamber to outside the processing chamber (e.g., partially outside the processing chamber)). In some examples, the platform further comprises a first panel 180 movable between a closed position and an open position, wherein the first panel 180 covers a first opening to the first processing chamber in the closed position and the first panel 180 does not cover the first opening to the first processing chamber in the open position. In some embodiments, the first panel is attached to, integrated with, or formed with (e.g., in a drawer configuration) the platform 140. In some embodiments, the first panel 180 is a separate structure from the platform 140 (e.g., a separate hinged door that covers and uncovers the first opening to the first processing chamber), and the platform 140 can slide in and out of the first processing chamber separately from the first panel 180.
[0084] In some embodiments, the platform and / or first panel can be locked to remain in a closed position during processing. By locking the first panel to remain in the closed position, the system 100 can prevent a user from prematurely accessing the contents of the platform 140 (e.g., accessing the processing chambers) during processing. In some embodiments, the first panel can be locked by a pin (e.g., a solenoid and pin) or a magnetic locking mechanism. The system 100 can allow a user to access the contents of the platform 140 before or after processing (e.g., loading biological fluid onto the platform 140, unloading biological fluid from the platform 140), or after an input (e.g., an input on a GUI, an input to open a latch, an input to a button switch) by unlocking the first panel.
[0085] 1 , the structure of platform 150 symmetrically mirrors the structure of platform 140 about a vertical axis. In another embodiment, platform 150 is substantially similar in size, shape, or orientation to platform 140. As illustrated, platforms 140 and 150 are horizontally disposed such that the first and second biological fluids are in the same plane when placed on the first and second platforms, respectively. As described above, first panel 180 may be associated with platform 140, and thus second panel 190 may be associated with platform 150.
[0086] While two platforms are shown as part of system 100 in FIG. 1 , system 100 may include one platform or three or more platforms substantially similar to platform 140 or platform 150 without departing from the scope of the present disclosure. In general, the number of illustrated platforms and processing chambers associated with systems 100-300 are exemplary, and embodiments of systems 100-300 may include different numbers and combinations of platforms, processing chambers, and their associated elements (e.g., scanners, optical arrays, compartments) without departing from the scope of the present disclosure. For example, in one or more embodiments, a system may include only one chamber with only one platform. In one or more embodiments, a system may include only one chamber with two or more platforms. In some embodiments, a system may include two chambers, each with only one platform. In some embodiments, a system may include two chambers, each with two or more platforms.
[0087] In some embodiments, the platform comprises a first compartment and a second compartment separate from the first compartment. In some embodiments, the first compartment is configured to hold (e.g., retain) a container containing a biological fluid (e.g., a container of a dual container assembly) in a position for illumination. In some embodiments, the second compartment is configured to hold a container not containing a biological fluid (e.g., a container of a dual container assembly) in a position not for illumination. In some embodiments, the platform is configured to separately retain at least a first container containing a first biological fluid and a second container containing a second biological fluid. In some examples, the platform is transparent to light of wavelengths within 100 nm (e.g., 75 nm, 50 nm, 40 nm, 30 nm, 20 nm) of the peak wavelength of the light used for illumination (e.g., substantially transparent, >95% transparent, >90% transparent, >80% transparent, >80% transparent, >70% transparent, >60% transparent, >50% transparent). In some embodiments, the platform is transparent (e.g., substantially transparent, >95% transparent, >90% transparent, >80% transparent, >80% transparent, >70% transparent, >60% transparent, >50% transparent) to ultraviolet light (e.g., UV-A, UV-B, and / or UV-C).
[0088] Figure 2 illustrates an exemplary system 200 for treating a biological fluid. In one or more embodiments, system 200 is substantially similar to system 100, as shown in Figure 1. Power switch 210 may correspond to power switch 110. Display 220 may correspond to display 120. Platforms 240 and 250 may correspond to platforms 140 and 150, respectively. Panels 280 and 290 may correspond to panels 180 and 190, respectively.
[0089] In some embodiments, system 200 includes an external scanner 230. As shown, external scanner 230 is external to the housing that houses the other elements and can be operably coupled to the processor of system 200. In some examples, external scanner 230 is a handheld scanner. Although external scanner 230 is shown in FIG. 2 with a wireless connection, external scanner 230 can be operably coupled using a wired connection.
[0090] As shown in Figure 2, platforms 240 and 250 are in a drawer configuration in an open position, in contrast to platforms 140 and 150, which are in a closed position in Figure 1. Although both platforms 240 and 250 are illustrated as open in a drawer configuration in Figure 2, only one platform in the drawer configuration can be open at a time (e.g., while the other remains closed).
[0091] In some embodiments, the first panel 280 and the second panel 290 associated with the platforms 240 and 250 lack any handles. In some embodiments, in the closed position, the panels can be opened by applying a force opposite to the opening direction (e.g., pushing on the exterior of the panel to engage a push latch that releases the panel to open). In some embodiments, in the closed position, the panels can be opened using a mechanical component (e.g., a motor, a servo) to actuate the panel (e.g., as a hinged door, as part of the platform in a drawer configuration). In some embodiments, the system allows a user to access the platform contents by opening the panel (e.g., by a spring mechanism), which then allows the user to manually slide it out of the platform. For example, following a determination that a processing procedure has begun or completed, the system can mechanically open one or more panels corresponding to the process to load or unload one or more biological fluid containers (e.g., processing bags).
[0092] In some embodiments, the platform includes a compartment 260 substantially similar to the compartments described herein. Although Figure 2 illustrates the platform with one compartment visible (e.g., for the platform in a drawer configuration in an open position), each of the platforms of system 200 can include any number of compartments without departing from the scope of application.
[0093] FIG. 3 illustrates an exemplary system 300 for processing biological fluids. In some embodiments, system 300 is substantially similar to system 100, except that the processing chamber and platform are vertically arranged. Power switch 310 can correspond to power switch 110. Display 320 can correspond to display 120. Scanner 330 can correspond to scanner 130. In contrast to system 100, in which platforms 140 and 150 are horizontally arranged, platforms 340 and 350 are vertically arranged such that the first and second biological fluids are in parallel planes when placed on the first and second platforms, respectively. Also, in contrast to system 300, in which panels 180 and 190 are horizontally arranged, panels 380 and 390 are vertically arranged.
[0094] The examples of Figures 1-3 are intended to provide an exemplary context for the system architectures described in detail below, and are in no way intended to be limiting of the architectures. The system architectures presented herein can be utilized in a variety of biological fluid treatment devices not described above with respect to Figures 1-3.
[0095] FIG. 4 illustrates an exemplary process diagram of a system for treating a biological fluid according to an embodiment of the present disclosure. Diagram 400 of FIG. 4 illustrates various components of a system for treating a biological fluid and provides a mapping of what function each component performs with respect to the treatment process. In the embodiment of FIG. 4, the diagram can include multiple processes 402, 404, 406, 408, and 410 that can collectively act together to treat the biological fluid. In one or more embodiments, devices and systems for treating biological fluid samples can include a light-sensing process 402 configured to monitor the amount of light (e.g., UV light) applied to a particular biological fluid. In one or more embodiments, the light-sensing process 402 can utilize (e.g., interact with) one or more light sensors (e.g., photodiodes) 412. The light sensor 412 can be configured to convert light into an electrical current. In one or more embodiments, the electrical current emitted from the light sensor 412 can be proportional to the amount of light received by the light sensor. The light-sensing process 402 can also interact with one or more light sources (e.g., UV light sources) 414. In one example, the light sensing process 402 may include using one or more light sensors 412 to sense light generated by one or more light sources (e.g., UV light sources) 414. In one or more examples, a current generated by the light sensors 412 based on the light generated by the light sources (e.g., UV light sources) 414 is sent to a controller 416, which ensures that the biological fluid being treated receives the appropriate amount of light necessary for treatment of the biological fluid.
[0096] In one or more embodiments, devices and systems for treating biological fluids can include an illumination process 404 configured to generate light (e.g., UV light) to be applied to a particular biological fluid. The illumination process 404 can include causing one or more light sources (e.g., UV light sources) 414 to generate light (e.g., UV light) (as described above) to treat the biological fluid. As shown in diagram 400, the illumination process 404 can act on both the biological fluid, such as blood components (e.g., platelets / plasma) 428, and a photoactive pathogen inactivation compound 430, such as a psoralen (e.g., amotosalen), in (e.g., in mixture with) the biological fluid.
[0097] In one or more embodiments, the apparatus can include an agitation process 406. The agitator 406 can be configured to agitate the contents of the processing vessel (e.g., during processing of the biological fluid by irradiation) to distribute (e.g., mix) and evenly distribute (e.g., distribute) the biological fluid and / or pathogen inactivation compound throughout the biological fluid. The agitation can facilitate processing, for example, by providing mixing of compounds (e.g., photochemical compounds, pathogen inactivation compounds) in the biological fluid or by maintaining components of the biological fluid (e.g., platelets, cells) in suspension. In one or more embodiments, the agitation process 406 can include causing a mechanical agitator 418 to agitate the biological fluid (e.g., the biological fluid containing the photoactive pathogen inactivation compound 430). In one or more embodiments, the controller 416 can control the agitator 418 to perform the agitation process 406. In one or more embodiments, one or more motors or servos (e.g., mounted to or on a platform) can be configured as the mechanical agitator 418. One or more motors or servos may be physically coupled to the platform or portion thereof and may move the platform or portion thereof (e.g., an associated tray) back and forth (e.g., along rails or tracks) to agitate a biological fluid held on the platform (e.g., a biological fluid in a container). The one or more motors or servos may be part of any suitable agitation design (e.g., a lead screw design in which the one or more motors or servos move a lead screw attached to the platform or portion thereof, a belt drive design in which the one or more motors or servos move one or more belts that rotate one or more gears (e.g., gears with teeth) that engage and move one or more tracks attached to the platform or portion thereof), and may operate based on control signals from electrical wiring electrically connected to a control circuit.In one or more examples, the system may be configured to control (e.g., adjustably control) one or more aspects of the agitation motion, such as offset (i.e., stroke length of reciprocating (linear, back-and-forth, etc.) motion during agitation), speed, acceleration, and deceleration. In some embodiments, the agitation speed may be adjustable (e.g., adjusted to have different speeds during different treatments, adjusted to have different speeds during a single treatment, adjusted based on a predetermined speed schedule, dynamically adjusted in real time based on real-time user input), and such control circuitry may control the agitator (e.g., one or more motors or servos) based on a control program implemented as software and / or hardware in the control circuitry.
[0098] In one or more embodiments, the device can include a transfer process 408. In one or more embodiments, the transfer process 408 can include the operations necessary to transfer biological fluid into and out of a processing chamber. For example, the transfer process 408 can include operating one or more doors of the illumination chamber 420 to open, close, lock, or unlock depending on the portion of the processing process in which the device is currently involved. In one or more embodiments, the controller 416 can control the illumination chamber 420 to perform the transfer process 408.
[0099] In one or more embodiments, the device can include a temperature management process 410. In one or more embodiments, the temperature process 410 can include operation of one or more hardware components (e.g., airflow and / or temperature sensor 422, heat exchanger 424, fan 426) collectively configured to maintain the device (e.g., where the biological fluid is being processed) within a particular temperature range. In one or more embodiments, the temperature management process 410 can be configured to operate one or more fans 426 that can act on the ambient air 432 (e.g., in conjunction with the heat exchanger 424) to cool the device when the internal temperature of the device (e.g., as detected by a temperature sensor (e.g., a thermistor) 422) exceeds a predetermined temperature threshold. In one or more embodiments, the controller 416 can control the one or more fans 426 to execute the temperature management process 410.
[0100] FIG. 5 is a perspective view of an exemplary system 500 for processing a biological fluid. In some embodiments, the system 500 is substantially similar to the system 100 shown in FIG. 1. The exemplary system 500 for processing a biological fluid includes a first processing chamber 502 and a second processing chamber 504 for receiving one or more biological fluids 510, and a light source array 506 arranged to irradiate the one or more biological fluids 510. In some embodiments, the light source array 506 may comprise the only light sources within the chambers 502 and 504 arranged to irradiate the one or more biological fluids 510. In other embodiments, described below with respect to FIG. 6, multiple light source arrays may be used to illuminate one or more biological fluids disposed in various embodiments of the chambers 502 and 504. As used herein, a "light source array" refers to one or more light sources arranged on any two-dimensional or three-dimensional surface (e.g., continuous surface, non-continuous surface).
[0101] One or more light source channels may be included in the array of light sources of the present disclosure. In some embodiments, one or more light source channels 508 are included in the array of light sources 506. While certain light sources are shown as belonging to certain light source channels, it is understood that different combinations of light sources may form different light source channels. Each light source channel 508 may be a set of one or more light sources having the same or substantially the same wavelengths (e.g., peak wavelength, maximum peak wavelength). In an exemplary set, one light source may have one peak wavelength. In another exemplary set, two light sources may have the same peak wavelength as each other. In yet another exemplary set, each of the multiple light sources may have a different peak wavelength from each other. In a further exemplary set, a first subset of one or more light sources may have one peak wavelength, and a second subset of one or more light sources may have a different peak wavelength. Within a light source channel having multiple light sources, all of the light sources can have respective peak wavelengths (e.g., maximum peak wavelengths) that are all within the wavelength range of the light source channel (e.g., 1 to 20 nm, 1 to 10 nm range, e.g., 1 nm, 2 nm, 3 nm, 4 nm, 5 nm, or more above and / or below a particular wavelength). For example, in some embodiments, within a light source channel having multiple light sources, all of the light sources can have peak wavelengths within the ranges described herein, e.g., about 315 nm to about 350 nm (e.g., about 315 nm to about 335 nm, about 330 nm to about 350 nm, about 340 nm to about 350 nm). Within a light source channel, each light source can be any light source that provides light with desirable characteristics (e.g., peak wavelength, maximum peak wavelength, spectral bandwidth), including, but not limited to, solid-state illumination (SSL), light-emitting diodes (LEDs), organic light-emitting diodes (OLEDs), polymer light-emitting diodes (PLEDs), and laser diodes. The light source channels of the light source array can be connected in series, parallel, or a combination of series and parallel circuits. In a light source channel having multiple light sources, the light sources can be controlled together or separately.
[0102] Each light source channel can be adjusted or configured to emit light (e.g., adjust the amount of light, adjust the amount of energy) at one or more peak wavelengths of light at different intensities that are applied to one or more portions of the biological fluid. For example, each light source channel can emit light at maximum intensity (e.g., 100%) or at less than maximum intensity (e.g., about 90%, about 80%, about 70%, about 60%, about 50%, 40%, about 30%, about 20%, or less).
[0103] Each light source channel may emit a different type of light. For example, each light source channel may emit ultraviolet light, ultraviolet-A light, ultraviolet-B light, ultraviolet-C light, and / or visible light. Furthermore, each light source channel may emit light of a different peak wavelength. For example, the emitted peak wavelength(s) may be in the ultraviolet-A spectrum (e.g., 315-400 nm), the ultraviolet-B spectrum (e.g., 280-315 nm), the ultraviolet-C spectrum (e.g., 100-280 nm, 200-280 nm, 240-280 nm), or the visible light spectrum (e.g., 400-800 nm). In some embodiments, the emitted peak wavelength(s) can be about 240 nm to about 250 nm, about 245 nm to about 255 nm, about 250 nm to about 260 nm, about 255 nm to about 265 nm, about 260 nm to about 270 nm, about 265 nm to about 275 nm, about 270 nm to about 280 nm, or about 275 nm to about 285 nm. In some embodiments, the emitted peak wavelength(s) can be about 280 nm to about 290 nm, about 285 nm to about 295 nm, about 290 nm to about 300 nm, about 300 nm to about 310 nm, about 305 nm to about 315 nm, or about 310 nm to about 320 nm. In some embodiments, the emitted peak wavelength(s) can be about 315 nm to about 325 nm, about 320 nm to about 330 nm, about 325 nm to about 335 nm, about 330 nm to about 340 nm, about 335 nm to about 345 nm, about 340 nm to about 350 nm, about 345 nm to about 355 nm, about 350 nm to about 360 nm, about 355 nm to about 365 nm, about 360 nm to about 370 nm, about 365 nm to about 375 nm, about 370 nm to about 380 nm, about 375 nm to about 385 nm, about 380 nm to about 390 nm, about 385 nm to about 395 nm, or about 390 nm to about 400 nm.In some embodiments, the emitted peak wavelength can be about 240 nm, about 245 nm, about 250 nm, about 255 nm, about 260 nm, about 265 nm, about 270 nm, about 275 nm, about 280 nm, about 285 nm, about 290 nm, about 295 nm, about 300 nm, about 305 nm, about 310 nm, about 315 nm, about 320 nm, about 325 nm, about 330 nm, about 335 nm, about 340 nm, about 345 nm, about 350 nm, about 355 nm, about 360 nm, about 365 nm, about 370 nm, about 375 nm, about 380 nm, about 385 nm, about 390 nm, about 395 nm, or about 400 nm. In some embodiments, the emitted peak wavelength can be about 255 nm to about 275 nm (e.g., about 260 nm to about 270 nm, about 265 nm). In some embodiments, the emitted peak wavelength can be about 275 nm to about 295 nm (e.g., about 280 nm to about 290 nm, about 285 nm). In some embodiments, the emitted peak wavelength can be about 300 nm to about 320 nm (e.g., about 305 nm to about 315 nm, about 310 nm). In some embodiments, the emitted peak wavelength can be about 315 nm to about 335 nm (e.g., about 320 nm to about 330 nm, about 325 nm). In some embodiments, the emitted peak wavelength can be about 330 nm to about 350 nm (e.g., about 335 nm to about 345 nm, about 340 nm to about 350 nm, about 340 nm, about 345 nm). In some embodiments, the emitted peak wavelength can be about 355 nm to about 375 nm (e.g., about 360 nm to about 370 nm, about 365 nm). In some embodiments, the emitted peak wavelength can be about 375 nm to about 395 nm (e.g., about 380 nm to about 390 nm, about 385 nm). In some embodiments, the emitted peak wavelength can be (1) in the ultraviolet-A spectrum (e.g., 315-400 nm), and (2) in the ultraviolet-B spectrum (e.g., 280-315 nm) or the ultraviolet-C spectrum (e.g., 100-280 nm, 200-280 nm, 240-280 nm).In some embodiments, the emitted peak wavelength is from about 315 nm to about 350 nm (e.g., from about 320 nm to about 345 nm, from about 315 nm to about 335 nm, from about 330 nm to about 350 nm, from about 340 nm to about 350 nm) in the ultraviolet A spectrum.
[0104] In some embodiments, all light source channels of a light source array may emit light of approximately the same peak wavelength (e.g., maximum peak wavelength) (e.g., within a variation range of ±1 nm, ±2 nm, ±3 nm, ±4 nm, ±5 nm, ±6 nm, ±7 nm, ±8 nm, ±9 nm, ±10 nm). For example, in some embodiments, all light source channels of a light source array may emit light of a peak wavelength of 325±10 nm, 330±10 nm, 335±10 nm, 340±10 nm, 325±5 nm, 330±5 nm, 335±5 nm, 340±5 nm, 345±5 nm, 345±4 nm, 345±3 nm, or 345±2 nm. A light source channel may include multiple light sources with different peak wavelengths (e.g., measured peak wavelengths) within the variation range. In some embodiments, the average peak wavelength across multiple light sources of a single light source channel may be the same as the specific peak wavelength of a specific light source within a single light source channel. In other embodiments, the average peak wavelength across the multiple light sources of a single light source channel (e.g., by about 1 nm, 2 nm, 3 nm, 4 nm, 5 nm, or more, more, or less) may differ from all of the specific peak wavelengths of each light source within a single light source channel. In some embodiments, some light source channels may emit light of a first peak wavelength, and other light source channels may emit light of a second peak wavelength. The first peak wavelength may differ from the second peak wavelength by at least (e.g., by more than) 5 nm, 10 nm, 15 nm, or 20 nm, or more. For example, in non-limiting embodiments, the first light source channel may emit light having a peak wavelength in the ultraviolet-A spectrum as described above (e.g., about 315 nm to about 335 nm, about 330 nm to about 350 nm, about 340 nm to about 350 nm), and the second light source channel may emit light having a peak wavelength in the ultraviolet-C spectrum as described above (e.g., about 250 nm to about 260 nm, about 260 nm to about 270 nm), or in the ultraviolet-B spectrum as described above (e.g., about 305 nm to about 315 nm).In another non-limiting embodiment, the first light source channel can emit light having a peak wavelength in the ultraviolet-A spectrum (e.g., about 330 nm to about 350 nm, about 340 nm to about 350 nm) as described above, and the second light source channel can also emit light having a peak wavelength in the ultraviolet-A spectrum (e.g., about 315 nm to about 335 nm, about 355 nm to about 375 nm) as described above. In some embodiments, the first peak wavelength is the average peak wavelength of one or more light sources in the first light source channel. In some embodiments, the array of light sources can include first, second, and third light source channels that emit light of first, second, and third peak wavelengths, respectively. In some embodiments, the first peak wavelength may differ from the second peak wavelength by at least (e.g., by more than) 5 nm, 10 nm, 15 nm, or 20 nm or more, and / or the second peak wavelength may differ from the third peak wavelength by at least (e.g., by more than) 5 nm, 10 nm, 15 nm, or 20 nm or more. Alternatively, each of the first, second, and third peak wavelengths may differ from one another by at least (e.g., by more than) 5 nm, 10 nm, 15 nm, or 20 nm or more. In some embodiments, the array of light sources may comprise first, second, third, and fourth light source channels, each emitting light at the first, second, third, and fourth peak wavelengths. In some embodiments, at least two, at least three, or at least four of the first, second, third, and fourth peak wavelengths may differ from one another by at least (e.g., by more than) 5 nm, 10 nm, 15 nm, or 20 nm or more. Alternatively, each of the first, second, third and fourth peak wavelengths may differ from one another by at least (eg, by more than) 5 nm, 10 nm, 15 nm, or 20 nm or more.Alternatively, the first peak wavelength may be approximately the same as (e.g., equal to) the third peak wavelength within a variation range of ±1 nm, ±2 nm, ±3 nm, ±4 nm, ±5 nm, the second peak wavelength may be approximately the same as (e.g., equal to) the fourth peak wavelength, and the first peak wavelength may differ from the second peak wavelength by at least (e.g., by more than) 5 nm, 10 nm, 15 nm, or 20 nm.
[0105] In some embodiments, each light source channel can emit light with a narrow spectral bandwidth. For example, the full width half maximum (FWHM) spectral bandwidth (e.g., the spectral bandwidth at the maximum peak intensity) of the light emitted by each light source channel can be less than 20 nm, less than 18 nm, less than 16 nm, less than 14 nm, less than 12 nm, less than 10 nm, less than 9 nm, less than 8 nm, less than 7 nm, less than 6 nm, or less than 5 nm. In some embodiments, the full width half maximum (FWHM) spectral bandwidth of the light emitted by each light source channel is within 10 nm shorter and / or within 10 nm longer than the peak wavelength (e.g., not more than 10 nm longer or not more than 10 nm shorter than the peak wavelength). In some embodiments, the full width half maximum (FWHM) spectral bandwidth of the light emitted by each light source channel can be greater than 1 nm, greater than 2 nm, greater than 3 nm, or greater than 4 nm, or even greater. In other examples, 50% of the maximum peak intensity of the light emitted by each light source channel is within 10 nm, 9 nm, 8 nm, 7 nm, 6 nm, 5 nm, 4 nm, or 3 nm of the peak wavelength (e.g., no more than 10 nm longer, no more than 10 nm shorter than the peak wavelength; no more than 10 nm shorter, no more than 10 nm longer than the peak wavelength). In other examples, the light intensity at 50% of the maximum peak intensity of the light emitted by each light source channel is within a spectral width of less than 20 nm, less than 18 nm, less than 16 nm, less than 14 nm, or less than 12 nm, less than 10 nm, less than 9 nm, less than 8 nm, less than 7 nm, 6 nm, or less than 5 nm (e.g., no more than 10 nm longer, no more than 10 nm shorter than the peak wavelength; no more than 10 nm shorter, no more than 10 nm longer than the peak wavelength). Commercially available LEDs and laser diodes are non-limiting examples of light sources capable of providing such narrow spectral bandwidth illumination at the peak wavelengths discussed above.
[0106] In some embodiments, one or more of the peak wavelength of the light emission, the spectral bandwidth of the light emission, the duration of the light emission, and the intensity of the light emission of each light source channel 508 can be adjusted or set.
[0107] Adjustment of these various light source channel parameters may be performed by control circuitry 520 operably coupled (e.g., communicatively coupled) to the processing chambers 502 and 504, the light source array 506, and / or the computer system 524. As used herein, "operably coupled" refers to any wired or wireless connection between two or more components that allows the two or more components to exchange information, control instructions, and / or control signals. As discussed in more detail below, the control circuitry 520 may receive control instructions and / or control signals from the computer system 524 and send control instructions and / or control signals to the various components of the processing chambers 502 and 504 to adjust or set various parameters associated with the various components of the chambers 502 and 504. Adjustment of the various parameters of the chambers 502 and 504 may be desirable to ensure that the processing parameters of the chambers follow a processing profile of one or more biological fluids 510. It should be appreciated that in some embodiments, the control circuitry 520 and / or the functionality of the control circuitry 520 may be included within the computer system 524. In some embodiments, the control circuitry 520 may include a computer system 524 and / or functionality of the computer system 524. In some embodiments, the control circuitry 520 may be structurally attached to the processing chambers 502 and 504 (e.g., on the outside, top, and / or bottom of the processing chambers 502 and 504). In some embodiments, the control circuitry 520 may be structurally integrated into the processing chambers 502 and 504 (e.g., located inside the processing chambers 502 and 504 or may form part of the structure of the processing chambers 502 and 504).
[0108] The computer system 524 can be operatively coupled (wired or wirelessly) to the control circuitry 520 and / or any of the various sensors discussed herein. The computer system can include one or more processors 544 (544 in FIG. 5 , 644 in FIG. 6 ), memory 542 (542 in FIG. 5 , 642 in FIG. 6 ), input / output (I / O) interfaces 546 (546 in FIG. 5 , 646 in FIG. 6 ), and a user interface (UI) 548 (548 in FIG. 5 , 648 in FIG. 6 ). The one or more processors 544 can be one or more of any type of general-purpose computer processor. The memory or computer-readable medium 542 can include one or more of readily available memory, such as random access memory (RAM), read-only memory (ROM), a floppy disk, a hard disk, an optical storage medium (e.g., a compact disk or digital video disk), a flash drive, or other form of digital storage, local or remote. In some embodiments, the non-transitory computer-readable storage medium of memory 542 can be used to store instructions for irradiating one or more biological fluids according to one or more treatment profiles, as described herein. Computer system 524 can encompass any type of computer, such as a personal computer (PC), desktop computer, laptop, computer terminal, server computer, tablet computer, smartphone, personal digital assistant (PDA), etc. In some embodiments, control circuitry 520 and / or the functionality of control circuitry 520 can be included within computer system 524.
[0109] At UI 548, a user can input one or more properties of a set of properties of one or more biological fluids (e.g., biological fluid 510). Alternatively, or in addition, one or more properties of the set of properties of the one or more biological fluids can be determined based on feedback input to computer system 524 and / or control circuitry 520 from one or more sensors for the processing chambers (e.g., processing chamber 502, processing chamber 504). Features in the feature set of a biological fluid can include, for example, the type of biological fluid (e.g., blood product, e.g., plasma, platelets, red blood cells; cells, e.g., eukaryotic cells; proteins, e.g., antibodies; vaccines), photochemicals in the biological fluid (e.g., type, volume, concentration), volume of the biological fluid, optical transparency of the biological fluid, type and / or shape of a container holding the biological fluid, and temperature of the biological fluid.
[0110] At UI 548, a user can input one or more parameters comprising a processing profile for one or more biological fluids (e.g., biological fluid 510). Alternatively, or in addition, computer system 524 can automatically determine one or more parameters of one or more processing profiles for one or more biological fluids (e.g., biological fluid 510) based on a respective set of one or more biological fluid characteristics. Specifically, memory 542 can store a computer program including instructions for mapping one or more characteristics of a biological fluid to one or more parameters of the biological fluid processing profile for each biological fluid. The instructions for mapping one or more characteristics of a biological fluid to one or more parameters of the biological fluid processing profile for each biological fluid may be implemented as a set of user-programmable rules.
[0111] In some embodiments, the light source array 506 may be thermally coupled to a heat exchanger 528 (e.g., a heat sink, fin heat sink, heat exchanger that may be operably coupled and controlled by the control circuitry 520). The heat exchanger 528 may remove thermal energy from the array 506 facing the one or more biological fluids 510, thereby minimizing the exposure of the biological fluids 510 to thermal energy (e.g., thermal energy that may damage biological function). Further control of the temperature of the chambers 502 and 504 and / or the temperature of the one or more biological fluids 510 may be provided by a heating / cooling unit 526 that may be operably coupled to and controlled by the control circuitry 520 and configured to adjust or set the temperature of the chambers 502 and 504. The heating / cooling unit 526 may be, for example, any suitable technology known in the art, such as, for example, a fan, a heat pump, a Peltier cooler, and / or a heat pipe. The heating / cooling unit 526 may be external to, internal to, and / or integrated with the chambers 502 and 504. For example, one or more fans may be located at the rear of the processing chamber(s) to draw air in through an inlet in the outer housing of the system 500 and exhaust the air out an exhaust port in the back of the outer housing.
[0112] In some embodiments, the heating / cooling unit 526 can be a heating unit, a cooling unit, or a heating-cooling unit. Through the use of the heating / cooling unit 526, the system 500 can control the heating / cooling unit 526 to maintain the temperature of the biological fluid within a certain temperature range (e.g., a 1° C. range, a 2° C. range, a 3° C. range, etc.) during treatment of the biological fluid by irradiation. For example, a heat or temperature sensor can provide a temperature indication or measurement to the control circuitry 520, or via the control circuitry 520 to the computer system 524. If the control circuitry 520 and / or the computer system 524 processes or interprets the temperature indication or measurement as indicating the crossing of a particular threshold or condition associated with a target temperature value or profile, the control circuitry 520 and / or the computer system 524 can instruct, command, enable, engage, or activate the heating / cooling unit 526 to take action to adjust the temperature of the chambers 502 or 504 and / or the temperature of one or more biological fluids 510. For example, the control circuitry 520 and / or computer system 524 can direct, command, enable, engage, or activate one or more fans to begin blowing air to begin cooling, to blow air faster to provide an increased cooling rate, to blow air slower to provide a decreased cooling rate, or to stop blowing air to stop cooling. Under the control of the control circuitry 520 and / or computer system 524, one or more fans may operate in an operational cycle to maintain the temperature of the biological fluid within a certain temperature range (e.g., a 1° C. range, a 2° C. range, a 3° C. range, etc.) during treatment of the biological fluid by irradiation. The control circuitry 520 and / or computer system 524 can direct, command, enable, engage, or activate any other suitable technology known in the art, such as, by way of example, a fan, a heat pump, a Peltier cooler, and / or a heat pipe, or any combination of such technologies, to take action to adjust the temperature of the chambers 502 or 504 and / or the temperature of the one or more biological fluids 510.
[0113] In some embodiments, the one or more fans may be positioned at the rear of the processing chamber(s). The one or more fans may blow air in a front-to-back or back-to-front direction, or both. In some embodiments, the one or more fans may draw air through the processing chamber(s) and exhaust the air through an exhaust vent at the rear of the system. The intake air to the one or more fans may enter through a vent located at or near the front or side(s) of the processing chamber(s), and the exhaust air from the one or more fans may exit through a vent located at the rear of the processing chamber(s).
[0114] The processing chambers 502 and 504 may further include multiple interior surfaces configured to absorb light (e.g., each configured to absorb light), such as, for example, one or more walls made of or coated with a material that substantially absorbs light of a particular wavelength (e.g., black plastic, black silicate, black paint). Alternatively or additionally, in some embodiments, the processing chambers 502 and 504 may further include one or more interior surfaces configured to reflect light (e.g., each configured to reflect light), such as, for example, one or more walls made of or coated with a material that substantially reflects light of a particular wavelength.
[0115] The processing chambers 502 and 504 may further comprise a platform 530 configured to hold one or more biological fluids 510 (e.g., containers of biological fluid). The platform 530 may be any support suitable for holding a biological fluid or a container of biological fluid. The platform 530 may be arranged in a "drawer configuration" such that it is slidably movable into and out of the chambers 502 and 504 manually. The platform 530 may also be slidably movable automatically by any suitable actuator, such as an electric motor or servo. The platform 530 holding the biological fluid 510 may be positioned above the light source array 506, with the light source array 506 facing the platform 530. However, in other embodiments, the platform 530 holding one or more biological fluids may be positioned below the light source array 506, with the light source array 506 facing the platform 530.
[0116] In some embodiments, the system 500 includes one or more scanners 532 in the processing chambers 502 and 504. The one or more scanners 532 may be positioned above the biological fluid 510 when the fluid is placed for processing (e.g., scanner 532A in the first processing chamber, scanner 532B in the second processing chamber). As shown, one or more scanners 532 (e.g., scanner 532C) may also be positioned outside the system 500 (e.g., on the exterior housing, exterior surface) between the first and second processing chambers. The one or more scanners 532 may be substantially similar to the scanners described herein. Once the biological fluid is placed in each processing chamber, each scanner in each chamber can obtain identifying information about the biological fluid as described herein. In some embodiments, the one or more scanners may be positioned at a first opening of the first processing chamber 502, a second opening of the second processing chamber 504, or openings of both chambers.
[0117] 6 is a perspective view of an exemplary system 600 for processing a biological fluid. In some embodiments, system 600 is substantially similar to system 500 as shown in FIG. 5. The exemplary system 600 for processing a biological fluid includes a first processing chamber 602 and a second processing chamber 604 for receiving one or more biological fluids 610, a first light source array 606 in each chamber arranged to illuminate the one or more biological fluids 610 from below, a second light source array 608 in each chamber arranged to illuminate the one or more biological fluids 610 from above, a platform 630 in each chamber configured to hold one or more biological fluids 610 (e.g., containers of biological fluid), and a sensor (e.g., scanner) 632 configured to obtain identification information of the biological fluid loaded into the processing chambers. A first light source array 606 and a second light source array 608, positioned above and below one or more biological fluids 610 in each of the processing chambers 602 and 604, provide illumination of the biological fluid from either one (i.e., above or below) or two (i.e., both) directions.
[0118] System 600 may include a scanner 632A disposed outside (e.g., on an external housing, exterior) of system 600 at a location associated with the first processing chamber 602 (e.g., at or near an opening of the first processing chamber 602) and a scanner 632B disposed outside (e.g., on an external housing, exterior) of system 600 at a location associated with the second processing chamber 604 (e.g., at or near an opening of the second processing chamber 604). System 600 may also include a scanner 632C disposed inside (e.g., on an interior wall, ceiling, floor) of system 600 between the first processing chamber 602 and the second processing chamber 604. In some embodiments, scanner 632C may be configured to acquire information from containers disposed in either or both processing chambers.
[0119] FIG. 7 is a perspective view of an exemplary system 700 for processing a biological fluid. In some embodiments, system 700 is substantially similar to system 300 shown in FIG. 3 and system 600 shown in FIG. 6 , except that a first processing chamber 702 and a second processing chamber 704 are arranged vertically (above and below each other) in system 700. The exemplary system 700 for processing a biological fluid includes a first processing chamber 702 and a second processing chamber 704 for receiving one or more biological fluids 710, a first light source array 706 in each chamber arranged to illuminate the one or more biological fluids 710 from below, a platform 730 in each chamber configured to hold one or more biological fluids 710 (e.g., containers of biological fluid), and a sensor (e.g., scanner) 732 configured to acquire identity information of the biological fluid placed in the processing chamber. The platform 730 holding the biological fluid 710 may be positioned above the light source array 706 with the light source array 706 facing the platform 730. However, in other embodiments, a platform 730 holding one or more biological fluids may be positioned below the light source array 706, with the light source array 706 facing the platform 730. Each of the light source chambers 702 and 704 may further include a second light source array (not shown) positioned above or below the one or more biological fluids 710, for example, similar to system 600, as shown in FIG.
[0120] System 700 can include scanners 732A and 732B located inside first processing chamber 702 (e.g., in the ceiling above the compartments for biological fluids 710A and 710B) and two scanners similarly located inside second processing chamber 704 (e.g., in the ceiling above the compartments for biological fluids 710C and 710D). System 700 can include scanner 732E located outside system 700 (e.g., on the external housing, exterior) between first processing chamber 702 and second processing chamber 704. In some embodiments, scanner 732E can be configured to acquire information from containers located in either or both processing chambers (e.g., when a platform in a drawer configuration is in an open position within the field of view of scanner 732E, when an RFID tag is within the detection range of scanner 732E).
[0121] FIG. 8A shows a perspective view of an exemplary system 800 for processing one or more biological fluids 806 and 808, including a light source array 804 disposed within a processing chamber 812. The light source array 804 faces a platform 810 for the biological fluids. The light source array 804 may be thermally coupled to a heat exchanger 816. The processing chamber 812 may include a platform 810 disposed below the light source array 804, the platform configured to hold one or more biological fluids 806 and 808. The processing chamber 812, the light source array 804, the heat exchanger 816, and the platform 810 may each be operably coupled to a control circuit 818 that can adjust or set respective parameters. FIG. 8B shows that the exemplary system 800 may also include a barrier (e.g., light barrier, protective barrier) 858 and various sensors 812, 866, 868, 880 within the processing chamber 812. In some embodiments, the barrier is transparent (e.g., substantially transparent, greater than 95% transparent, greater than 90% transparent, greater than 80% transparent, greater than 80% transparent) to light having wavelengths within 30 nm of the first peak wavelength (e.g., within 15 nanometers shorter, within 15 nanometers longer than the first peak wavelength; not more than 15 nanometers longer, not more than 15 nanometers shorter than the first peak wavelength). In some embodiments, the barrier is transparent (e.g., substantially transparent, greater than 95% transparent, greater than 90% transparent, greater than 80% transparent, greater than 80% transparent) to ultraviolet light, such as light having wavelengths in the ultraviolet A spectrum. In some embodiments, the barrier is a light barrier (e.g., a light filter) configured to reduce the transmittance of (e.g., minimize, attenuate, block) light, such as light having wavelengths less than the wavelengths of light in the UVA spectrum. In some embodiments, the barrier is a light barrier configured to reduce the transmittance of light having wavelengths less than the wavelengths of light in the UVB spectrum.In some embodiments, the barrier is a light barrier (e.g., a light filter) configured to reduce (e.g., minimize, attenuate, block) the transmittance of light having a wavelength at least 20 nm shorter (e.g., at least 25 nm shorter, at least 30 nm shorter) than the first peak wavelength and / or another peak wavelength (e.g., at least 20 nm shorter than the second, third, or fourth peak wavelength). In some embodiments, the barrier is a light barrier (e.g., a light filter) configured to reduce the transmittance of light having a wavelength at least 20 nm longer (e.g., at least 25 nm longer, at least 30 nm longer) than the first peak wavelength and / or another peak wavelength (e.g., at least 20 nm longer than the second, third, or fourth peak wavelength). Barrier 858 is disposed between the array of light sources 804 and platform 810 (e.g., one or more biological fluids 806 and 808). Sensors 812, 866, 868 may be attached to or disposed on platform 810. The sensor 880 may be attached to (eg, above or below) the barrier 858 or may be disposed within the barrier 858 .
[0122] The light source array 804 can include an array of light source channels, each of which can be configured to emit light at a different peak wavelength as described above, and in a different arrangement of the light sources and light source channels as described above.
[0123] Both the light source array 804 and the platform 810 can be configured to translate relative to one another to increase or decrease the distance 826 between them, similar to the translation described above. The platform 810 can be lowered to the bottom of the processing chamber 812, which can be elevated from or flush with an external bottom surface (e.g., a floor, ground, desk, etc.). The light source array 804 can be elevated to the top of the processing chamber 812. In FIG. 8B , the light source array 804, barrier 858, and platform 810 can all be configured to translate relative to one another to increase or decrease the distances 826, 882, and 884 between any pair of the light source array 804, barrier 858, and platform 810. This translation can be effected by any number of actuators (e.g., electric motors, servos, etc.) controlled by a control circuit 818, which can separately control the translation of the light source array 804, barrier 858, and platform 810. In some embodiments, one or two of the light source array 804, the barrier 858, and the platform 810 may be fixed in a predetermined position within the processing chamber 812. For example, the barrier 858 may be fixed in a position within the processing chamber 812. As another example, the barrier 858 and the light source array 804 may be fixed in a predetermined position relative to each other at a fixed distance 882 within the processing chamber 812, where the platform 810 may be configured to move to increase or decrease the distances 826 and 884. As another example, the barrier 858 and the platform 810 may be fixed in a predetermined position relative to each other at a fixed distance 884 within the processing chamber 812, where the light source array 804 may be configured to move to increase or decrease the distances 826 and 882.
[0124] As discussed above with respect to FIGS. 1-8(a and b), a biological fluid processing system (e.g., an electronic processing device) can include numerous components and systems that must work in concert to safely and effectively process biological fluids. The above examples may illustrate exemplary layouts of components used to process one or more biological fluids in a device in which two processing chambers are oriented horizontally relative to one another and / or in which the processing chambers are oriented vertically relative to one another. FIG. 9 illustrates another exemplary internal hardware layout of a system for processing biological fluids according to embodiments of the present disclosure. In an embodiment of device 900, the processing chambers can be oriented vertically relative to one another so that when the device is simultaneously processing two biological fluids, the biological fluids can be positioned one above the other within the device.
[0125] System (e.g., electronic device for processing biological fluids) 900 can include two separate processing chambers 918 and 920, such that in an embodiment of system 900, processing chambers 918 and 920 can be oriented perpendicular to one another. In one or more embodiments, each processing chamber 918 and 920 can include one or more platforms (e.g., drawers) and associated trays 908 configured to carry biological fluids (e.g., in containers) and make the biological fluids accessible to a user who can remove and / or place the biological fluids within the device. In one or more embodiments, system 900 can be configured with an agitator (e.g., motor, servo), such as an agitator configured (e.g., connected, coupled, integrated) on platform 908, so that any biological fluid carried on platform (e.g., drawer and associated tray) 908 can be agitated during processing. In one or more embodiments, each platform (e.g., drawer) 908 can be configured with an agitator (e.g., motor, servo), such as, for example, an integrated agitator, so that any biological fluid carried on the platform (e.g., drawer and associated tray) 908 can be agitated during processing.
[0126] In one or more embodiments, each processing chamber 918 and 920 can also include one or more modular light device (e.g., light engine) components 910. In one or more embodiments, the modular light device component 910 of each processing chamber 918 and 920 can include one or more light source arrays (e.g., UV light sources) configured to irradiate a desired amount of light (e.g., UV light) onto a biological fluid disposed within each processing chamber (e.g., on a platform within the processing chamber).
[0127] In one or more embodiments, as described in further detail below, the system (e.g., electronic device) 900 can include a control system board (CSB) 904 configured to coordinate the operation of one or more components of the device, such as safety-critical components of the device. In one or more embodiments, a safety-critical component may refer to one or more components of the electronic device that interact with the biological fluid being treated, the improper operation of which may jeopardize the safety and effectiveness of the treatment process on the biological fluid (e.g., meeting required specifications). In one or more embodiments, the CSB 904 can be configured to communicate with and issue commands to each of the safety-critical components (described in further detail below) using a domain-specific, customized communication protocol configured to protect the safety-critical components from access by unauthorized (e.g., malicious) users, allowing the device to be modular and scalable while minimizing operational interruptions and / or maintaining regulatory compliance of the device. In one or more embodiments, the CSB 904 can be configured to communicate with and control the operation of, among other things, the platform (e.g., drawers and associated trays) 908 and the optical device components 910; these components directly interact with the biological sample, and therefore improper operation of these components could jeopardize the safety and / or effectiveness of the treatment process. In one or more embodiments, the CSB 904 can also be configured to operate one or more fans 912 to move air through the electronics (e.g., drawing air from the front of the electronics to the back of the device) to cool the device and the biological fluid being treated and prevent overheating. In addition to controlling each of the components, the system CSB 904 can be configured to evaluate, and in one or more embodiments, continuously communicate with, the results from each of the components.The CSB 904 can be configured to use the results to determine subsequent operational steps for the device, for example, to stop agitation, start and / or stop illumination, or complete a treatment process.
[0128] In addition to the processing chamber-specific components described above, in one or more embodiments, the electronic device 900 can include one or more components that are not dedicated to a particular processing chamber but instead are configured to operate the entire device and are therefore common to both processing chambers. In one or more embodiments, the electronic device 900 can include a user interface controller (UIC) 902 that can be configured to manage the operation of one or more components of the device 900. In one or more embodiments, the UIC 902 can be configured to coordinate the operation of one or more non-safety-critical hardware and software components (described in further detail below). For example, in one or more embodiments, the UIC 902 can be configured to operate one or more graphical user interfaces that are displayed on the display 914. The one or more graphical user interfaces can be configured to guide a user through the treatment process and receive input from the user to determine information about the biological fluid being treated and other information the device may need to perform the treatment process. In one or more embodiments, the display 914 can be implemented as a “touch display” that allows a user to touch the surface of the display to enter any input or otherwise interact with the device during the treatment process.
[0129] In one or more embodiments, the UIC 902 may also communicate with and control a scanner (e.g., a barcode scanner) 916. The scanner 916 may be configured to scan one or more sources of identification information (e.g., barcodes) found on containers holding biological fluids, including information related to the identification of the biological fluid and other information necessary to ensure proper processing of the material.
[0130] As shown in Figure 8B, the system can include multiple components and sensors that work in conjunction with one another to deliver light to a sample for processing. For example, as described above with respect to Figure 8B, the processing chamber 812 can include a light source array 804 and one or more sensors 812, 866, 868, and 880 that work in conjunction with one another to illuminate the sample during processing. In one or more embodiments of the present disclosure, the sensors 812, 866, 868, and 880 can include a combination of light sensors (e.g., photodiodes) and temperature sensors (e.g., thermistors) that are configured (jointly configured) to ensure that the biological fluid being processed is uniformly illuminated with a precise amount (e.g., dose) of light and that the light source and / or illumination process operates at a temperature that does not overheat the entire apparatus.
[0131] However, if one of the components working together to deliver UV light to the biological fluid fails, is upgraded, or reaches the end of its life, simply replacing that component can be a difficult and complicated process. For example, if one or more LEDs in the light source array 804 fail, preventing the entire light source array from delivering an adequate amount of UV light to the biological fluid, simply replacing the light source array may not be sufficient to return the electronic device to its normal operating state. For example, because sensors may be positioned and configured relative to the light source array originally installed in the device, replacing that light source array may require reconfiguring one or more sensors. For example, in the example of photodiodes, the LEDs in the light source array may not be in the same position as the previous light arrangement, so if the light source array is changed, the position of one or more photodiodes may need to be reconfigured. Without repositioning the photodiodes, it may not be possible to accurately capture the light generated by the light source array to determine whether sufficient light is being transmitted to the sample being processed. Alternatively, or additionally, if one or more of the light source arrays 804 are replaced with different light source arrays, simply replacing the light source array may not be sufficient to return the electronic device to its normal operating state. For example, upgrading or modifying the light sources (e.g., LEDs) in the light source array to incorporate different peak wavelength(s), increase the efficiency of the light source, change the beam width, etc., may require modifying the photodiodes of the light sensor.
[0132] In addition to reconfiguring some or all of the components associated with light delivery, replacing a component(s) may also require significant time and labor to electrically reconnect all of the various components (i.e., light source arrays and sensors) and ensure (e.g., verify) that the components are interacting with each other to deliver the appropriate amount of UV light to the biological fluid being treated. For example, if light source array 804 is replaced, in one or more embodiments, it may be necessary to reconnect the light source array to the various sensors 812, 866, 868, and 880 to ensure that the components can communicate with each other and operate the overall device in a safe and efficient manner.
[0133] Thus, in one or more embodiments, it may be advantageous to house multiple or all of the components associated with light delivery (i.e., light source array, sensors, and other control electronics) in a single housing so that if one of the components fails or is upgraded, the entire light delivery system can be replaced together, eliminating the need to reconfigure and reconnect each of the other components to the replaced component. Returning to the embodiment of FIG. 9 , in one or more embodiments, each light device 910 can include substantially all of the components and sensors associated with delivering UV light to the biological fluid being treated. As described in more detail below, by providing a light device that is standalone and includes the sensors and components necessary for light delivery, the light device can be made “modular” so that the entire light device can be replaced if one or more components of the light device fail, are upgraded, or are nearing the end of their life.
[0134] As shown in FIG. 9 , an electronic device for processing biological fluids can include four light device components 910 and two platforms (e.g., and associated trays) 908. The number of light device components 910 and platforms 908 shown in FIG. 9 is intended as an example only and should not be considered limiting. An electronic device for processing biological fluids can include more or less of each component. In one or more embodiments of the present disclosure, each platform 908 (which holds biological fluid for processing (e.g., a container containing biological fluid) during use) can have two light device components 910 directed thereto, one disposed above the platform and one disposed below the platform, with the light source of each light device component directed (e.g., directed) toward the platform and configured to irradiate a particular amount of UV light onto the biological fluid on the platform (e.g., and associated tray). Thus, in one or more embodiments, the light device components 910 disposed above the platform 908 can be oriented such that light generated by the components is directed downward toward the platform 908, while the light device components 910 disposed below the platform 908 can be directed upward toward the platform 908. In this manner, the platform (e.g., and associated tray) 908 holding the biological fluid can be treated with UV light emitted from above and below. As discussed above, if any one of the components of the light device components 910 malfunctions or otherwise needs to be replaced (e.g., upgraded), it would be advantageous to be able to easily replace a single unit that houses all of the light-irradiation components, rather than simply attempting to replace the failed or upgraded component. Thus, in one or more embodiments of the present disclosure, the light device components can be housed in a single device that is configured to be modular and easily replaceable if one of the components malfunctions or otherwise requires replacement.
[0135] In one or more embodiments, the light device components 910 may be substantially identical in that they all include identical components having the same configuration. However, in one or more embodiments, each set of light device components 910 (which may be housed in a single light device) may be configured differently from one another. For example, one of the light device components 910 associated with a given processing chamber may be configured to emit light of a particular peak wavelength (e.g., UV-A light), while another of the light device components 910 may be configured to emit light of a different peak wavelength (e.g., UV-B or UV-C light). In such a scenario, biological fluids present on the platform 908 during a processing process may be simultaneously treated by two light sources emitting light of different wavelengths (e.g., peak wavelengths). Such a need may arise if it is determined that a pathogen inactivation process can benefit from treatment with both UV-A and UV-B or UV-C light.
[0136] FIG. 10 illustrates an exemplary modular light device for use in a system (e.g., an electronic device) for treating a biological fluid according to embodiments of the present disclosure. As shown in the embodiment of FIG. 10 and described in further detail below, the modular light device 1000 can be configured to house multiple components, such as substantially all of the components (e.g., light sources) and sensors (e.g., a self-contained light device) necessary to generate light and irradiate the biological fluid being treated (e.g., with a desired dose of UV light). In one or more embodiments of the present disclosure, the modular light device 1000 can include a housing 1002 configured to house the components within the light device. In one or more embodiments, the housing 1002 can include a window portion (e.g., a transparent material portion) 1004 configured to allow a light source housed within the modular light device 1000 to irradiate the biological fluid being treated (i.e., configured to transmit light from the light source). In one or more embodiments, the window portion can be an opening in the housing. In one or more embodiments, the window portion can protect the light source array(s) and light source(s) from potential contamination (e.g., biological fluids, dust). In one or more embodiments, the window portion can comprise a window material covering / surrounding an opening to the light source array chamber. In one or more embodiments, the window portion (e.g., transparent material portion) 1004 can be configured to be UV-transparent (e.g., made of a material selected to transmit or pass selected wavelengths of light). In one or more embodiments, the window portion (e.g., transparent material portion) 1004 can be made from a material (e.g., a transparent material, a transmissive material) such as glass, quartz-based, plastic, acrylic, or other polymeric (e.g., thermoplastic) material configured to transmit a significant amount of the light energy generated by the device. In one or more embodiments, the window portion 1004 can be configured to be UV-transparent (i.e., >50% transparent, >60% transparent, >70% transparent, >80% transparent, >90% transparent, >95% transparent).In one or more examples, the transmittance of the window portion 1004 can be correlated to the amount of light illuminated by the modular light device 1000. Thus, in one or more examples, a modular light device 1000 having a window 1004 with only 80% transmittance can be configured to produce light at a higher intensity than a window 1004 with 90% transmittance to illuminate a precise amount of light into the biological fluid being treated. In one or more embodiments, the window portion can be comprised of a flat (e.g., planar) window portion (e.g., window material). In one or more embodiments, the window portion can be comprised of a curved (e.g., convex, concave) material portion.
[0137] In one or more embodiments of the present disclosure, the window portion 1004 can include one or more light sensors (e.g., photodiodes) disposed on or across the window 1004 (e.g., facing the light source, light source array(s)). In one or more embodiments, the window portion 1004 can include one or more circuits (e.g., cables, PCB traces, flexible circuit strips) 1006 disposed on or across the window 1004 (e.g., facing the light source, light source array(s)) and can be configured to support one or more light sensors (e.g., photodiodes facing the light source, light source array(s)). As described in further detail below, the photodiodes disposed on the circuit (e.g., flex circuit) 1006 can be configured to measure the amount of light being illuminated by a light source, such as, for example, a light source array (e.g., an LED array) housed within the modular light device 1000. In one or more embodiments, the light sensors can be implemented using any number of light-sensing technologies, including, for example, UV photocells and / or photodiodes. In one or more embodiments, each circuit is a flex circuit, and because each flex circuit may cast a shadow on the optical path, the flex circuits may be, for example, about 5 millimeters or less, about 4 millimeters or less, or about 3 millimeters or less in width to minimize potential interference with the light irradiating the biological fluid. While the flex circuits 1006 may create shadowing in the optical path of the modular optical device, the shadowing (representing a noise source) may be modulated (i.e., averaged) in one or more embodiments by agitation of the biological fluid in the processing chamber and / or the number and / or placement of light sources in the light source array. Thus, in some examples, the agitation process used to process the biological fluid may also act to minimize performance degradation associated with shadowing. In one or more embodiments, each of the three flex circuits 1006 may be configured to hold three light sensors (e.g., photodiodes), such that the three flex circuits 1006 can collectively hold nine light sensors (e.g., photodiodes).While adding more light sensors (e.g., photodiodes) and / or flex circuits may lead to more accurate measurements of the light generated by the modular light device 1000, it may also lead to more blockage or obstruction of the light irradiated onto the biological fluid. Similarly, including fewer (i.e., fewer) light sensors (e.g., photodiodes) and / or flex circuits may reduce shadows generated by the flex circuit 1006, but may lead to a loss of accuracy in the light measurements. Thus, the amount of photodiodes and flex circuits may represent a design trade-off between measurement accuracy and shadowing of the light generated by the modular light device 1000.
[0138] In one or more embodiments of the present disclosure, the modular light device 1000 may include a light source array chamber / cavity (e.g., LED array chamber) 1008 disposed below (e.g., within) the window 1004 and configured to hold multiple light sources (e.g., LEDs), sensors, and other components necessary to generate light for processing (discussed in further detail below). In one or more embodiments, the light source array chamber (e.g., LED array chamber) 1008 may include one or more light source arrays (e.g., LED arrays) 1010. The light source array (e.g., LED array) 1010 (discussed in further detail below with respect to FIG. 11 ) may include one or more light sources (e.g., LEDs) and light sensors (e.g., photodiodes), and optionally, one or more temperature sensors. In addition to the one or more light source arrays (e.g., LED arrays) 1010, the light source array chamber (e.g., LED array chamber) 1008 may include one or more reflectors 1012 disposed on the sides of the chamber 1008 and configured to surround the periphery of the light source array(s) (e.g., LED array) 1010. The reflectors 1012 may be configured to redirect light generated by the light sources (e.g., LEDs) around the light source array (LED array) 1010 back toward the window (e.g., a central portion of the window) 1004, minimizing loss of light energy at the edges of the light source array chamber (e.g., LED array chamber) 1008. In this way, the light sources (e.g., LEDs) around the light source array(s) (e.g., LED array) can direct light (e.g., some of the light) toward the walls of the light source array chamber (e.g., LED array chamber) 1008 rather than directing it toward the biological fluid being treated, and the reflector 1012 can redirect that light toward and back through the window 1004 so that the light is not wasted and can be used to treat the biological fluid, thereby improving the overall efficiency of the light source array(s) (e.g., LED array) 1010.Thus, the reflector 1012 helps to conserve potentially wasted light energy while also ensuring that the modular light device 1000 produces a more uniform amount of light (e.g., across the entire device, across the surface of the biological fluid being treated, and within the irradiance).
[0139] In one or more embodiments of the present disclosure, the modular light device 1000 can include one or more interfaces (e.g., ports) for electrically connecting the modular light device to various components of an electronic processing device. In one or more embodiments, the modular light device 1000 can include an interface panel 1014 disposed on a side of the housing 1002. The interface panel 1014 can include one or more interfaces for electrically connecting the modular light device 1010 to various components of an electronic processing device. In one or more embodiments, the interface panel 1014 can include an interlock connector 1016. When connected to an electronic device, the interlock connector 1016 can be configured to allow the electronic device to quickly and efficiently shut down the modular light device if the device encounters a condition, fault, or situation where continued operation of the modular light device 1010 is undesirable. As an example, if the electronic device detects that there is a problem with the biological fluid being processed (i.e., the biological fluid is not properly loaded into the tray or processing chamber) or that the agitator has failed, the device can quickly shut down the modular light device 1000 through the use of the interlock connector 1016.
[0140] In one or more embodiments, the interface panel 1014 may include a power port 1018 configured to connect the modular light device 1000 to a power source of an electronic processing device. In this manner, the modular light device 1000 does not need to carry its own power source, but instead can be connected to the power source of the electronic device once the modular light device 1000 is installed in the electronic device. In one or more embodiments of the present disclosure, the power port 1018 may be configured to connect an external power source to internal components of the electronic device that require power, such as light sources (e.g., LEDs), sensors, etc. In one or more embodiments, the power port 1018 may be configured to transfer power from the external power source to one or more controllers / drivers (described in more detail below), which may be configured to distribute the power to various components within the modular light device 1000. In one or more embodiments, the power port 1018 may be rated at 48V, and the modular light device itself may be configured to consume approximately 225W of power.
[0141] In one or more embodiments, the interface panel 1014 may include a communications port, such as, for example, an Ethernet port 1020. The Ethernet port 1020 may be configured to provide networking capabilities to the modular light device 1000 when connected to the device. As described in further detail below, the Ethernet port may allow the modular light device to communicate with other safety-critical components within the electronic device using a specialized domain-specific communications protocol configured to isolate the safety-critical components of the electronic device from interference from external sources.
[0142] In one or more embodiments of the present disclosure, the modular light device 1000 may include a heat exchanger 1022 disposed at the bottom (e.g., base) of the housing 1002. As described in further detail below, the heat exchanger may be shaped and configured to reduce or remove heat generated by various components of the modular light device away from the modular light device (e.g., away from the biological fluid) in order to maintain the modular light device, the processing chamber, and / or the biological fluid at a desired operating temperature (e.g., within a desired operating temperature range).
[0143] FIG. 11 illustrates a top view of an exemplary modular light device 1100 for use in a system for treating biological fluids, according to embodiments of the present disclosure. FIG. 11 further illustrates components found within the light source array chamber (e.g., LED array chamber) 1008 of FIG. 10. As shown in FIG. 11, the modular light device 1100 can include multiple light sources, such as UV LEDs 1102, configured to generate UV light during operation of the modular light device 1100. In one or more embodiments, the multiple LED light sources 1102 of the light source array(s) can be distributed across one or more panels 1108. For example, in the embodiment of FIG. 11, the light source array chamber (e.g., LED array chamber) 1008 can include three panels 1108 disposed on the interior base of the chamber, and the LED light sources 1102 can be distributed across the three panels such that a portion of the LED light sources are disposed on each panel 1108. The number of light sources (e.g., LEDs) 1102 in the light source array chamber 1008 can depend on many factors. In one or more embodiments, each modular light device 1100 of the electronic processing device can be configured to generate light across the entire surface of a processing bag or other processing vessel (e.g., containing biological fluid) at a particular depth of the biological fluid within the processing bag and / or around a predetermined irradiance (e.g., fluid contained within the predetermined irradiance) surrounding the processing bag. In one or more embodiments, the predetermined irradiance can represent a three-dimensional space around the platform (e.g., and associated tray) to which a substantially uniform amount of light is delivered by the light device. Thus, at a predetermined irradiance, the modular light device can be configured to provide a substantially uniform amount of light according to predetermined specifications. The size of the irradiance and the intensity of light required to illuminate the irradiance can serve as factors in determining the number of light sources (e.g., LED light sources) to be included in each modular light device 1100.
[0144] In one or more embodiments, the uniformity of light within the irradiance can be quantified as a function of the irradiance of the light source. Thus, in one or more embodiments, the light sources can be collectively configured to illuminate the biological fluid in the processing chamber with less than a 25% (e.g., less than 20%, less than 15%, less than 10%) variation in irradiance across the surface of the biological fluid (e.g., the liquid container, the liquid container blocking surface) facing the light source. In some embodiments, the light source can illuminate the biological fluid within the processing chamber with less than a 25% (e.g., less than 20%, less than 15%, less than 10%) variation in irradiance across any 5 cm (e.g., less than 5 cm) of the biological fluid (e.g., the container containing the biological fluid) within the processing chamber. 2 The area is configured to irradiate with less than a 25% variation from the integrated irradiance (averaged over the surface area) across the entire biological fluid (eg, a vessel containing the biological fluid) blocking surface.
[0145] In one or more embodiments, the surface of the biological fluid can be defined, for example, by the surface of a biological fluid container holding the fluid, or by a plane intersecting any portion of the biological fluid. In one embodiment, the light sources can be configured (e.g., arranged in an array) such that the light sources illuminate the biological fluid with less than a 25% (e.g., less than a 20%, less than a 15%, less than a 10%) variation in irradiance across the surface of the biological fluid facing the array of light sources. In other words, the light intensity at any portion of the surface of the biological fluid facing the array of light sources can differ by less than a 25% (e.g., less than a 20%, less than a 15%, less than a 10%) difference from the light intensity at any other portion of the surface of the biological fluid facing the array of light sources.
[0146] In one or more embodiments, the modular light device 1100 can include 216 LEDs 1102 within the LED array chamber 1008. In one or more embodiments, the LED array chamber 1008 can include more or fewer LEDs. In addition to the irradiance and treatment process requirements, the number of LEDs can be influenced by the size of the LED array chamber (e.g., the distance from the window to the array of LEDs) 1008, the power specifications of the modular light device 1000, and the desired treatment time of the biological fluid being treated. For example, if the desired UV treatment dose for the biological fluid is 6.3 J / cm from the desired combination of treatment time and intensity, 2 In some embodiments, 216 LEDs can provide the required light dose. However, in one or more embodiments, using fewer LEDs and / or lower intensities in the modular light device can reduce power requirements, but may require more time for the biological fluid to be processed. Conversely, using more LEDs and / or higher intensities in the chamber can reduce the time required for processing, but may increase power and temperature costs associated with increasing the number of LEDs and / or higher intensities. In one or more embodiments of the present disclosure, the modular light device 1000 can include 5 or more, 10 or more, 25 or more, 50 or more, 100 or more, 150 or more, 200 or more, 250 or more, 300 or more, or 400 or more light sources (e.g., LEDs) in the light source array chamber 1008. In one or more embodiments of the present disclosure, the modular light device 1000 can include 500 or less, 400 or less, 300 or less, 250 or less, 200 or less, 150 or less, or 100 or less light sources (e.g., LEDs) within the light source array chamber 1008, such as 50-400, 100-300, or 150-250 light sources.
[0147] As shown in FIG. 11 in one or more embodiments of the present disclosure, the light source array chamber (e.g., LED array chamber) can include one or more light sensors (e.g., photodiodes) 1104 disposed on the printed circuit board(s) on which the LEDs themselves are disposed. The photodiodes 1104 can be included in addition to the photodiodes disposed on the flex circuit(s) 1006 described above (the photodiodes 1104 disposed on the flex circuit(s) 1006 can be seen in the diagram provided by FIG. 12 ). In contrast to the photodiodes disposed on the flex circuit(s) 1006, the photodiodes 1104 can be oriented to capture light transmitted by a second modular light device disposed on the opposite side of the processing chamber (e.g., platform, processing bag) from the modular light device 1000, and can therefore be configured to measure light transmitted by the second modular light device. As described above, the photodiodes on the flex circuit 1006 can be oriented and configured to capture light transmitted directly by the modular light device itself toward the processing chamber (e.g., platform, processing bag).
[0148] In one or more embodiments, the modular light device 1100 may include nine photodiodes 1104 disposed on the printed circuit board(s) (e.g., three per circuit board) of the light array chamber 1008 and another nine (e.g., three per flex circuit) 1006 disposed on the flex circuit(s) described above, for a total of 18 photodiodes. The number of photodiodes included in any modular light device may be determined, for example, by the required measurement accuracy, the configuration of the light source array(s), and the space constraints imposed by the modular light device. Thus, in one or more embodiments, the modular light device may include more photodiodes, which improves measurement accuracy, but at the expense of, for example, closer component spacing or increased light engine volume. Conversely, the modular light device 1000 may include fewer photodiodes, which may, for example, reduce the overall footprint of the light device, but at the expense of measurement accuracy. In one or more embodiments of the present disclosure, the modular light device 1000 can include 2 or more, 4 or more, 6 or more, 8 or more, 10 or more, 15 or more, 20 or more, 25 or more, or 30 or more photodiodes (e.g., disposed on one or both of the printed circuit board(s) and flex circuit(s) described above). In one or more examples, the photodiodes can be connected to control electronics (described in more detail below) such that if it is determined that the modular light device is not producing an adequate amount of light (or if the other modular light device in the treatment chamber is not producing an adequate amount of light), corrective action can be taken by the device (e.g., by alerting an operator to the condition, adjusting the intensity of the light source, adjusting the current to the light source, or terminating the treatment process). Alternatively, or in addition, in one or more embodiments, the photodiodes can be connected to control electronics (described in more detail below) such that the presence or absence of biological fluid in the treatment chamber can be determined based on the amount of light transmitted by the modular light device on the other side of the treatment chamber.
[0149] In one or more examples, the light array chamber 1008 of the modular light device 1000 can include one or more temperature sensors 1106. The temperature sensor 1106 can be configured to measure the temperature of the modular light device 1000. During operation of the modular light device, the light sources (e.g., LEDs) can generate a significant amount of heat energy in addition to transmitting light energy. The temperature sensor 1106 can be configured to measure the heat emitted by the LED light sources to ensure that the LED light sources are operating within their specifications and / or the specifications of the biotreatment profile. In one or more examples, the temperature sensor can be connected to control electronics (described in more detail below) so that the light device can be shut down or other corrective action can be taken if the modular light device is determined to be operating at a temperature that exceeds its specifications. In some embodiments, the LED light sources can be modulated, such as cycled between on and off (e.g., pulse modulated), in response to temperature measurements by the sensor(s). The temperature sensor (e.g., each temperature sensor) 1106 can be attached, for example, to an LED junction (i.e., the junction between the LED and the PCB on which the LED is located), since the LED is responsible for a large portion of the heat generated by the light device. Alternatively, or in addition, the temperature sensor (e.g., each temperature sensor) 1106 can be attached, for example, to a printed circuit board of the light array chamber 1008. In one or more embodiments, the temperature sensor can be implemented using a thermistor (or any other component configured to measure changes in temperature) that can change resistance proportional to the temperature of the light array chamber 1008. Furthermore, the one or more temperature sensors can be implemented using various types of sensors, such as a thermocouple, an infrared sensor, a bimetallic device, a thermometer, a state change sensor, a silicon diode, etc. In one or more embodiments, the modular light device 1000 can include a total of six temperature sensors.Similar to the photodiodes 1104, the light array chamber 1008 can include any number of temperature sensors (e.g., 1 or more, 2 or more, 3 or more, 4 or more, 5 or more, 8 or more, or 10 or more). A greater number of temperature sensors can provide greater measurement accuracy, but may come at the expense of space. Conversely, fewer temperature sensors can, for example, require less space, but may come at the expense of measurement accuracy.
[0150] FIG. 12 illustrates a side view (cross-section) of an exemplary modular light device for use in a system (e.g., an electronic processing device) for treating biological fluids, according to embodiments of the present disclosure. The side view 1200 of the light device 1000 provided in FIG. 12 can better illustrate some additional features of the light device, according to one or more embodiments of the present disclosure. For example, as shown in the side view 1200, the light device 1000 includes a control circuit 1202 contained within the housing of the light device 1002 (for purposes of illustration, the control circuit housing 1002 has been removed to reveal the control circuit). The control circuit 1202 can include both a controller PCB 1204 and one or more light source (e.g., LED) driver PCBs 1206. In one or more embodiments of the present disclosure, the controller PCB 1204 can be configured to function as the “brains” of the light device. In one or more embodiments of the present disclosure, the controller PCB 1204 can facilitate communication between a broader processing device and the light device 1000 itself, and can be configured to operate one or more LED PCBs 1206. In one or more embodiments of the present disclosure, the controller PCB 1204 may include one or more microprocessors, memory, and communication interfaces.
[0151] In one or more embodiments of the present disclosure, the LED driver PCB 1206 can be configured to regulate the current and power of each LED 1102 disposed on the light source array of the light array chamber 1008. In one or more embodiments, the modular light device 1000 can include two LED driver PCBs 1206, each including 18 driver chips configured to collectively regulate the current and power of the 216 LEDs 1102 disposed in the illumination array chamber 1008. In one or more embodiments, the LED driver PCBs 1206 can be configured to ensure that the light device 1000 complies with the IEC 61010 standard. For example, each driver of the LED driver PCB 1206 can include its own temperature sensor. The number of LED driver PCBs, as well as the total number of driver chips, can be more or less and can be largely a function of the number of LEDs 1102 disposed in the light array chamber 1008. In one or more embodiments of the present disclosure, each driver chip of the LED driver PCB 1206 can include a dedicated temperature sensor configured to monitor the temperature of the modular light device. In another exemplary embodiment of light device 1000, the control circuitry, including controller PCB 1204 and LED driver PCB 1206, may be integrated into the system-wide CSB controller described above. However, integrating these control units into light device 1000 itself may make the design more modular in that replacing (e.g., upgrading) the light device may be a simple matter of replacing the entire unit, rather than having to access the system-wide CSB controller to upgrade the control electronics associated with light device 1000.
[0152] The side view 1200 of FIG. 12 may also serve to illustrate the beam angles 1208 of the individual light sources (e.g., LEDs) disposed on the LED PCB 1206. In one or more embodiments, the beam angle of an LED may represent the angle at which light generated by the LED is distributed or emitted. As discussed above, LED placement may be significantly influenced by the desired illumination surface area or volume of the processing bag. Thus, in one or more embodiments, LEDs having an appropriate beam angle 1208 may be selected to meet illumination specifications. In one or more examples of the present disclosure, the selected beam angle may be approximately 120°, although the angle may be greater or less (e.g., between about 100° and about 140°, between about 110° and about 130°, between about 115° and about 125°, about 100°, about 110°, about 115°, about 125°, about 130°, about 140°). In one or more embodiments of the present disclosure, each LED can achieve a desired beam angle by including a lens and / or packaging for each LED that can focus the light to the desired beam angle. Additionally, the side view 1200 can be useful to show a light sensor 1212 (e.g., a photodiode) of the flex circuit(s) 1006 disposed on the window 1004, which faces and detects light emitted from the light sources on the light source array(s) of the modular light device.
[0153] FIG. 13 illustrates a bottom view of an exemplary modular light device for use in a system for treating biological fluids (e.g., an electronic processing device) according to embodiments of the present disclosure. The bottom view 1300 of the light device 1000 provided in FIG. 13 can better illustrate a heat exchanger 1302, which can be configured to remove heat generated by the light device during operation. In one or more embodiments of the present disclosure, the heat exchanger 1302 can be shaped to maximize the surface area of the device exposed to air drawn or blown through the heat exchanger from one or more fans (e.g., external fans) located on the electronic processing device. In one or more embodiments, the heat exchanger 1302 can be configured such that air moving (e.g., blowing) past the heat exchanger 1302 from or to the fan(s) transfers to air passing through the light device 1000, creating the effect of lowering the overall temperature of the light source array and / or modular light device.
[0154] 13 , in one or more examples, the heat exchanger 1302 can be shaped as fins of a particular height and width, but a larger height and width can be selected to maximize the surface area exposed to the air blowing through it; a larger height and width increases the size of the overall footprint of the light device, and thus the height and width of the heat exchanger 1302 can be constrained by any size requirements imposed on the light device. The shape of the heat exchanger 1302 can be configured to allow air to be drawn or blown past the exchanger so that it circulates over and between the individual fins of the heat exchanger 1302. In this way, the amount of surface area exposed to the airflow is maximized.
[0155] In one or more embodiments, rather than using air to move heat out of modular light device 1000, in one or more embodiments light device 1000 can include other forms of active cooling, such as active cooling that circulates a liquid coolant (e.g., around heat exchanger 1302) to cool light device 1000. In one or more embodiments, light device 1000 can also use passive cooling to cool the light device, where one or more heat exchangers 1302 are configured to utilize natural conduction, convection, and radiation to cool light device 1000.
[0156] As indicated above, in one or more embodiments of the present disclosure, the modular light device 1000 may include multiple heat sinks configured to exchange heat with air passing over them provided by one or more fans external to the light device (i.e., on the processing device). However, as will be described below, in one or more embodiments, the light device 1000 may include its own fan that is housed internally within the light device and may be part of the modular structure.
[0157] FIG. 14 illustrates an exemplary fan structure for implementing a light device for use in a system for treating biological fluids according to embodiments of the present disclosure. In another embodiment, as shown in FIG. 14 , a modular light device 1402 can include one or more fans 1404 as part of the light device. In the light device 1402 embodiment, the one or more fans 1404 can be configured to blow or draw air through the light source array chamber, for example, through multiple internal heat sinks or heat exchangers configured to exchange heat from the LEDs of the light device. Including fans as part of the light device can lead to a more modular design in that additional components that operate the light device 1402 are co-located within a single light device. This can lead to more efficient modularity, as the light device itself has more direct control over its own cooling mechanism.
[0158] However, in one or more embodiments, the inclusion of one or more fans as part of the modular light device 1402 may also increase the overall weight and size of the light device. For example, as shown in FIG. 14 , a light device 1406 that does not include one or more fans as part of the light device may have a smaller footprint than a light device 1402 that includes fans as part of the light device. As an example, a light device 1402 that includes an internal fan 1404 may have a greater height and weight than a light device 1406 that does not include an internal fan. Thus, using a “fanless” design in which the light device relies on an external fan (such as a fan that is a component of an electronic processing device) or passive cooling may allow the light device to be smaller and lighter, and the light device design may be more modular (i.e., easier to replace). In one or more embodiments, a modular light device that does not include an internal fan (e.g., “fanless”) may have a height of 6 inches or less, 5 inches or less, 4 inches or less, or 3 inches or less.
[0159] To support the modular design of the optical devices (i.e., to allow the optical devices to be easily removed and replaced, for example, if the optical device fails, otherwise does not function according to desired operation, or for upgrades), the electronic processing device itself can be configured to support the modularity of the optical devices. In other words, the processing device can be configured to mechanically support the modular optical devices and facilitate their easy removal or addition. Configuring the processing device to facilitate efficient removal and replacement of optical devices can make replacing optical devices more efficient, as a machine operator simply "slides out" the modular optical device (e.g., from the side, front, or back) and "slides in" a replacement, making only a minimal number of electrical connections (e.g., power, Ethernet, interlocks as described above).
[0160] FIG. 15A shows another view of an exemplary internal hardware layout of a system for processing a biological fluid (e.g., an electronic processing device) according to embodiments of the present disclosure. Diagram 1500 of FIG. 15A depicts a side view (e.g., cross-sectional view) of the processing device. In one or more embodiments, if a modular light device is replaced, in one or more embodiments, a side panel of the processing device can be removed as shown in FIG. 15A, thereby providing access to one or more modular light devices resident within the device. As shown in side view 1500 of FIG. 15A, processing device 1502 can include four separate modular light devices 1504, 1506, 1508, and 1510. Similar to the above-described embodiments, light devices 1504 and 1506 can be configured and arranged to provide substantially uniform light (e.g., UV light) to processing platform 1512 (e.g., and associated trays) and biological fluid disposed on the platform. Light devices 1508 and 1510 can be constructed and arranged to provide substantially uniform light (eg, UV light) to processing platform 1514 (eg, and biological fluid disposed thereon).
[0161] In one or more embodiments, the electronic processing device 1502 can include four separate sets (e.g., pairs) of mechanical rails 1516, 1518, 1520, and 1522 oriented from one side of the electronic device to the other, configured to allow each optical device to slide therein so that the optical device is mechanically supported by the processing device. In one or more embodiments, each set of rails 1516, 1518, 1520, and 1522 can include two rails located on either side of the electronic device. FIG. 15 shows a single rail for each set of rails 1516, 1518, 1520, and 1522. The second rail of each set is located on the opposite side of the electronic device and is not visible. Thus, in one or more embodiments, tracks provided on the housing of the modular optical device 1504 can slide into the rails 1516 of the processing device 1502 (e.g., from the side of the processing device 1502) to mechanically support the optical device 1504. Tracks on the housing of light device 1506 are slidable onto rails 1518 on processing device 1502 to mechanically support light device 1506. Tracks on the housing of light device 1508 are slidable onto rails 1520 on processing device 1502 to mechanically support light device 1508. Finally, tracks on the housing of light device 1510 are slidable onto rails 1522 on processing device 1502 to mechanically support light device 1510. By providing the processing device with a set of tracks that complement the set of rails on each modular light device so that the light devices can be slid into the processing device during replacement, replacing modular light devices becomes an efficient and easy process.
[0162] 15B shows another exemplary diagram of a modular light device according to an example of the present disclosure. Diagram 1524 of FIG. 15B can, in one or more embodiments, serve to illustrate a track 1526 (discussed above with respect to FIG. 15A ) of the light device configured to slide on any one of rails 1516, 1518, 1520, and 1522 of processing device 1502 to mechanically support light device 1508. As shown in diagram 1524 provided by FIG. 15B , track 1526 can be shaped such that it can mate with the rails to prevent sliding or lateral movement of the light device once positioned on rails 1516, 1518, 1520, and 1522 as it slides on them.
[0163] In one or more embodiments of the present disclosure, the modular light devices can be subjected to a testing process (e.g., a sanity check process) to ensure that each of the modular light devices in the electronic processing equipment is operating according to their requirements, that the windows of the light devices are free of light path obstructions or other occlusions (e.g., dust, scratches, dirt, etc.), and / or that the platform (e.g., associated tray) of the processing equipment is free of light path obstructions. In one or more embodiments, the testing process (e.g., a sanity check process) can be performed when one or more light devices are initially installed / replaced in the processing equipment and / or can be performed intermittently throughout the operational life of the equipment (e.g., before each processing process). In one or more embodiments, the testing process can be performed to determine the presence or absence of a biological fluid to be processed (e.g., a container with a biological fluid) (e.g., in a processing chamber on the platform of the electronic processing equipment).
[0164] FIG. 16 illustrates an exemplary modular light device testing process (e.g., to determine whether there is a window and / or platform obstruction or other occlusion (e.g., contamination) that prevents the light from fully and / or evenly illuminating the processing sample) in accordance with embodiments of the present disclosure. In one or more embodiments of the present disclosure, the process 1600 illustrated in FIG. 16 can begin at step 1602, where one or more processors associated with the light device itself or associated with the processing device can generally initiate a check process for the light device and / or processing device. In one or more embodiments, the light device and / or electronic processing device testing process (e.g., a health check process) can be initiated when there is no biological fluid being processed within the device and no biological fluid loaded onto the platform (e.g., in an associated tray). In this manner, the light device health check process is performed during a time when no processing is occurring, so that it does not interfere with the overall processing process, and the presence of biological fluid disposed on the platform does not interfere with the health check process.
[0165] Once the process begins at step 1602, process 1600 proceeds to step 1604, where both light devices associated with a single platform (e.g., an associated tray) (see above) are both turned off (e.g., if currently on) so that neither light device transmits light. Once both light devices associated with the platform are turned off or blocked in step 1604, process 1600 proceeds to step 1606, where the first of the two light devices is activated. As will become apparent from the following discussion, by turning on only one light device at a time to perform a health check, the exact light source measured during the health check can be known. In contrast, if both light devices were activated simultaneously during a health check, it could be difficult to ascertain where the measured light is coming from or to accurately measure it.
[0166] Once the first light device is activated in step 1606, process 1600 proceeds to 1608, where light coming from the first light device (e.g., passing through the platform of the processing chamber) can be measured using a photodiode on a second light device. As described above, one or more photodiodes located directly on the light array (e.g., LED PCB) are oriented to specifically capture light transmitted from another light device on the opposite side of the platform (e.g., and associated tray). In contrast, one or more photodiodes located on the flexible circuit (described above) can be oriented to measure light transmitted by the light device itself. In one or more embodiments of the present disclosure, the photodiode on the flexible circuit of the first light device can also measure light coming from the same (e.g., first) light device.
[0167] Once the light transmitted by the first lighting device is measured by the second lighting device in step 1608, the process proceeds to step 1610, where the light source (e.g., LED) of the first lighting device can be shut off. Once shut off, the process can proceed to step 1616 (described below) or directly to step 1612, where the light source (e.g., LEDs) of the second lighting device is activated (e.g., to check the health of the second lighting device and / or electronics). Once the second lighting device is turned on in step 1612, process 1600 proceeds to step 1614, where the light transmitted by the second lighting device (e.g., passing through the platform of the processing chamber) can be measured by one or more photodiodes of the first lighting device in a manner substantially similar to the process described above in steps 1606-1610. In one or more embodiments of the present disclosure, the photodiode on the flexible circuit of the second lighting device can also measure light coming from the same (e.g., second) lighting device.
[0168] Once the light from the second light device is measured by the first light device in step 1614, process 1600 proceeds to step 1616, where a determination is made as to the health of the light device(s) and / or electronic device (e.g., platform) based on the measurements obtained in steps 1608 and 1614. In one or more embodiments, if it is determined that one or more of the light devices or electronic devices does not pass the health test, the processing device may send an alert to a user in the form of a graphical user interface (GUI) displayed on a display of the processing device. After the health of the light device(s) is determined in step 1616, process 1600 proceeds to step 1618 and ends.
[0169] While the process described above with respect to FIG. 16 can determine the health of each modular light device and whether light from each light device is being transmitted to (e.g., through) the platform (e.g., and associated tray) holding the process vessel, in one or more embodiments, the health checks described above may not be sufficient to determine whether a desired dose (e.g., illumination amount) is being achieved. For example, the process described above with respect to FIG. 16 may not be able to measure (e.g., properly measure) the total dose (e.g., to the surface of the biological fluid, measuring irradiance) because the process is configured to determine whether the light source (e.g., LED) of each light device is transmitting light and whether there are no occlusions blocking the transmitted light. Thus, in one or more embodiments, calibration procedures can be performed intermittently throughout the operational lifecycle of the light devices to determine whether individual and / or combined light devices are providing the desired amount of light (e.g., generating the appropriate amount of illumination, generating the appropriate irradiance). Based on such calibration procedures, adjustments can be made, such as increasing the intensity of one or more light sources (e.g., LEDs) to compensate for a decrease in the efficiency of the light over time. In one embodiment, such an increase in intensity allows the apparatus to maintain a substantially constant treatment process time (eg, as experienced by an operator) over the lifecycle of the light source.
[0170] 17A illustrates an exemplary light device calibration process according to embodiments of the present disclosure. Process 1700 can utilize a calibration device that can be implemented as a component (e.g., separate from the modular light devices, separate from the electronics device) configured to be placed on the device's platform (e.g., and associated tray), where the calibration device is comprised of multiple photodiodes or other light sensors that can measure the amount of light received from one or both modular light devices and calculate various factors, including the total dose (e.g., irradiance) delivered. In one or more embodiments, process 1700 for calibrating a light device can begin at step 1702, where the calibration device is placed on the platform (e.g., associated tray) of the processing device (which typically holds biological fluids / processing containers during processing device operation).
[0171] In one or more embodiments, once the calibration device is placed in place on the platform in step 1702, process 1700 proceeds to step 1704, where one or more light devices configured to illuminate the platform are activated (i.e., the LEDs of the light device(s) are turned on and light is transmitted through the calibration device). After the one or more light devices are activated in step 1704, process 1700 proceeds to step 1706, where one or more light measurement devices of the calibration device (i.e., photodiodes) may record measurements regarding the light received from the one or more light devices. In one or more embodiments, once the measurements are taken in step 1706, process 1700 proceeds to step 1708, where the calibration device (or a processor connected to the calibration device) may calculate the irradiance (e.g., dose, exposure). In one or more embodiments, in step 1708, the calibration device may send an indication to a user of the device as to whether the device received the proper dose during the test or whether the test failed. Once the illumination is calculated in step 1708, the process 1700 proceeds to step 1710 and ends.
[0172] FIG. 17B illustrates another exemplary calibration process according to embodiments of the present disclosure. In one or more embodiments, process 1712 of FIG. 17B may be substantially similar to the process of FIG. 17A. For example, steps 1714, 1716, and 1718 may be substantially similar to steps 1702, 1704, and 1706 of FIG. 17A. Accordingly, the descriptions of steps 1702, 1704, and 1706 above may be referenced to understand the details of steps 1714, 1716, and 1718, respectively. In one or more embodiments, once a light measurement is obtained in step 1718, process 1714 may proceed to step 1720, where the measurement obtained in step 1718 may be compared to a predetermined threshold (e.g., a predetermined dose). In one or more embodiments, the predetermined threshold may represent a value below which, if the measurement obtained in step 1718 falls, indicates that the current processing time required by the device to inactivate pathogens is inadequate (e.g., insufficient exposure, insufficient dose). In one or more embodiments, the predetermined threshold may be empirically determined. In one or more embodiments, the calibration device may take the measurements and transmit the measurements to a processing device or modular light device (e.g., via an electronic device) to perform the comparison of step 1720. Additionally or alternatively, the calibration device itself may perform the comparison of step 1720.
[0173] In one or more embodiments, in response to a calibration test in which the measurement obtained in 1718 differs from an expected or desired amount (e.g., a predetermined threshold in step 1720), an adjustment can be made to the light emitted by one or more light sources of the light device, e.g., based on communication between the electronic device and the light device. In one or more embodiments, in response to a calibration test in which the measurement obtained in 1718 is below a predetermined threshold in step 1720, the device can extend the treatment time to compensate for the lower amount of light received by the biological fluid during the treatment process. However, in one or more embodiments, extending the treatment time may be undesirable because it may reduce the overall efficiency and productivity of the treatment device. Thus, in one or more embodiments, if the measurement obtained in step 1718 is below a predetermined threshold in step 1720, in one or more embodiments, process 1714 proceeds to step 1722, where the intensity of the light source (e.g., the light source of the light device) used during calibration process 1714 can be adjusted (i.e., increased) to account for (e.g., compensate for) the lower amount of light. In this way, rather than having to increase the processing time to account for lower light output from the light source, the intensity of the light source can be increased, thereby keeping the processing time substantially constant throughout the life of the light device. In embodiments where the calibration device performs the comparison described with respect to step 1720, the calibration device can then, in one or more embodiments, send instructions to the electronic device to adjust the intensity, as described above with respect to step 1722.
[0174] A modular light device may be considered a safety-critical component insofar as failure or malicious manipulation of the light device could lead to a failed (e.g., non-meeting predetermined criteria) or unsafe treatment process. In one or more embodiments, if the modular light device fails or if a malicious user gains access to the light device in a way that allows for direct control, the biological fluid being treated may be deemed unsafe for use. Accordingly, as described in more detail below, the modular light device described above may be configured to operate with a wider range of electronic processing devices and to be compatible with one or more features (e.g., safety features, modular component aspects, and / or domain-specific communication protocols) of the processing devices described below.
[0175] FIG. 18 illustrates an exemplary system diagram of an illumination system (e.g., electronic processing device) for treating a biological fluid according to embodiments of the present disclosure. In one or more embodiments, the biological fluid treated by system 1800 may include one or more of platelets, plasma, blood, and blood products. As described above with respect to FIGS. 1-3 , the device can treat the biological fluid by irradiating the biological fluid with light (e.g., ultraviolet light), such as, in one or more embodiments, having wavelengths in the ultraviolet-A (UV-A), UV-B, and / or UV-C spectrum. To treat the fluid using light, the device can be configured to irradiate the biological fluid with light (e.g., ultraviolet light, UVA light) for a predetermined time (e.g., to achieve a desired dose) and at a particular intensity in order to inactivate pathogens. In one or more embodiments, the device can treat a biological fluid mixed with a pathogen-inactivating compound (e.g., a photoactive compound) with light (e.g., UV light).
[0176] In one or more embodiments of the present disclosure, system 1800 may include a control module 1816 and a processing module 1802. In one or more embodiments of the present disclosure, processing module 1802 may include two subsystems: (1) a primary subsystem 1804 and a safety subsystem 1814. In one or more embodiments of the present disclosure, primary subsystem 1804 may include components and systems that perform light treatment (e.g., UVA light treatment), while safety subsystem (described in more detail below) may include components and systems configured to monitor activities performed by primary subsystem 1804.
[0177] In one or more embodiments, the primary subsystem 1804 may include one or more modular light devices 1806 that include light source(s) (e.g., light source array(s)) for treating the biological fluid. Each modular light device 1806 may include one or more light sources that may be configured to emit light (e.g., UVA light) of variable intensity and that are positioned within the device such that when the light sources are emitting, the biological fluid within the device is exposed to the light (e.g., light waves) emitted from the light sources. In some embodiments of the present disclosure, the biological fluid may be contained within a container (e.g., a bag), which may be placed within the device, such as a platform (e.g., and associated tray), and may be exposed to the light (e.g., light waves) emitted from the light sources.
[0178] The primary subsystem 1804 may also include one or more chambers (not shown) for receiving processing vessels (e.g., bags) containing the biological fluid to be processed. The processing vessels may be positioned on a platform (e.g., associated product tray) 1808 within the processing chamber. Each processing chamber may have one or more modular light devices associated with it. For example, each chamber may receive light (e.g., UVA light) from one or more light devices 1806 to process the biological fluid in the processing vessels within the processing chamber. In another example, multiple processing vessels (e.g., bags) may be processed simultaneously in multiple processing chambers.
[0179] In some examples, the primary subsystem may include an agitator 1810. The agitator 1810 may be used to agitate the contents of the treatment vessel to distribute (e.g., evenly distribute) (e.g., mix) the biological fluid and / or pathogen inactivation compound throughout the biological fluid. The primary system may further include various components 1812 to perform various other functions that assist in the treatment process. These functions include, but are not limited to, one or more sensors (e.g., for detecting light, light intensity, or light amount), detection of treatment vessel placement, and a marking mechanism to indicate that treatment has occurred in a particular treatment vessel.
[0180] In some examples of the present disclosure, a safety subsystem 1814 within processing module 1802 may be used to monitor processing activity occurring in primary subsystem 1804. Functionality of safety subsystem 1814 may include, but is not limited to, interlocks, lockouts, hardware and software watchdogs, etc.
[0181] In some embodiments, the illumination processing system 1800 may include a control module 1816 that may enable a user to make processing requests and interact with the lighting system 1800. In some embodiments, the control module 1816 may be physically separate from the lighting system 1800. If physically separate, the control module 1816 may be connected to the lighting system 1800 by wire or wirelessly using a predetermined wireless communication standard, such as Bluetooth or WiFi. In some embodiments, one control module 1816 may be associated with multiple systems, such as the lighting system 1800.
[0182] In one or more embodiments of the present disclosure, the control module 1816 may include a user interface 1818. The user interface 1818 may be a display that allows a user to interact with the lighting system 1800. In one or more embodiments, the user interface 1818 may be implemented as an LCD display with a touchscreen interface that utilizes user-selectable buttons, icons, and text to facilitate user interaction with the device. The user interface may include input / output devices such as a touchpad, keyboard, mouse, camera for reading barcodes, etc.
[0183] In one or more embodiments of the present disclosure, the system 1800 can include a common interface 1822. In some examples, the system 1800 is an electronic device for processing biological fluids, and the common interface 1822 is a processing interface of the electronic device.
[0184] In some embodiments, the common interface 1822 is communicatively coupled to the control module 1816 (e.g., the control subsystem 1820 of the control module 1816), the primary subsystem 1804, and the safety subsystem 1814. The common interface 1822 can be configured to provide a communication path between the control module 1816 and the primary subsystem 1804 or the safety subsystem 1814. In some embodiments, communication between the control module and the subsystems is triggered by an input to the user interface 1818. In some embodiments, communication between the control module and the subsystems is triggered by the introduction of a subsystem or component into the lighting system (e.g., a modular light device is installed in the system).
[0185] The above-described modules, components, and systems may include various components associated with their respective functions, which may be arranged in a system architecture that allows these components to be coordinated with one another to facilitate effective and efficient processing of one or more biological fluids.
[0186] FIG. 19 shows another exemplary system diagram of a lighting system for treating biological fluids, according to embodiments of the present disclosure. In some embodiments of the present disclosure, the system architecture 1900 can include a control module 1916 and a processing module 1902. The control module 1916 can include a control subsystem 1920 that can perform various functions. For example, the control subsystem 1920 can manage graphic icons, screen transitions, button presses, and other user interactions with a user interface 1918. It can print a record of the operations that have occurred. It can function as a communications manager by interacting with a network external to the lighting system 1900, for example, via Ethernet. In one or more embodiments, the control subsystem 1920 can also function as a data manager by maintaining a database of operations that have occurred. In one or more embodiments, the control subsystem 1920 can also function as an event log manager by recording different events that occur (e.g., internal and / or external) of the lighting system 1900. These events include, but are not limited to, normal and abnormal environmental conditions, alarms, malfunctions, etc. In one or more embodiments, the controller may be a CPU or microprocessor and may include volatile and non-volatile memory.
[0187] In one or more embodiments, the control subsystem 1920 can enable communication between the control module 1916 and an external network via a port (e.g., an Ethernet port) 1926. For example, any device external to the lighting system 1900 can connect to the control subsystem 1920 via the port 1926. These devices can include, but are not limited to, an external personal computer, an external blood management system to send and receive data from the lighting system 1900, etc. For example, the blood management system can collect reports from the lighting system 1900. It can also send software and data to the lighting system 1900 to perform different control functions. These functions can include, but are not limited to, programming the lighting system 1900 with different processing profiles and user information, performing maintenance and health checks (e.g., diagnostics) of the lighting system 1900, etc.
[0188] In one or more embodiments, the control module 1916 may be isolated from the processing module 1902 with the aid of a common interface 1922 (described in further detail below). For example, such isolation may serve to physically separate the critical functions of the processing module 1902 from the non-critical functions of the control module 1916. In one or more embodiments of the present disclosure, the separation between critical and non-critical components may allow safety-critical software and hardware requiring more rigorous testing to be placed in the processing module 1902, and non-safety-critical software and hardware to be placed in the control module 1916. In this manner, the impact caused by replacing or changing a non-critical component of the device for a critical component may be minimized.
[0189] In some embodiments, the common interface enables communication between the control module 1916 and the processing module 1902 using a predefined, domain-specific communication protocol. For example, a control subsystem 1920 (which may be implemented as a controller in one or more examples) in the control module 1916 may communicate with a separate controller 1924 in the processing module 1902.
[0190] In one or more embodiments, the control subsystem 1920 may be communicatively coupled to one or more non-safety critical components disposed within the control module 1916 and may also be communicatively coupled to the processing module 1902 via a controller 1924. The controller 1924 within the processing module 1902 may be communicatively coupled to one or more safety critical components, such as a light device 1928 and an agitator 1910, and may also be communicatively coupled to the control subsystem 1920 of the control module 1916.
[0191] In one or more embodiments, the control subsystem 1920's only interface with components of the processing module 1902 may be through the controller 1924, while the controller 1924's only interface with components in the control module 1916 may be through the control subsystem 1920. In this manner, isolation between non-safety-critical components in the control module 1916 and safety-critical components in the processing module 1902 may be maintained. By maintaining this isolation using two separate controllers, the impact on the processing module 1902 caused by future changes to components in the control module 1916 (i.e., component modifications or enhancements) may be minimized. Thus, changes to the control module 1916 may not require having to engage in tedious retesting of components in the processing module 1902 that must pass regulatory scrutiny. Furthermore, by using a predefined domain-specific communication protocol 1922 to facilitate communication between the control subsystem 1920 and the controller 1924, further isolation between the non-safety-critical components in the control module 1916 and the processing module 1902 may be further maintained. The domain-specific interface protocol 522 used to communicate between the control subsystem 1920 and the controller 1924 may represent a way for the two modules 1916 and 1920 to remain consistent despite changes in the components that make up the control module 1916 and the processing module 1902.
[0192] In one or more examples, the controller 1924 may perform safety-related functions in the processing module 1902. For example, the controller 1924 may monitor that the illuminator system 1900 is handled in a safe and appropriate manner and may implement interlock or lockout mechanisms if an unsafe or improper condition is detected. The controller 1924 may also implement programmed alarms to indicate errors occurring during the processing process and to display alarm information to a user via the user interface 1918. In some embodiments, the controller 1924 may also perform processing tasks by managing different components within the lighting system 1900 according to a specific processing profile. For example, the controller 1924 may control how much light energy (e.g., UVA energy) a biological fluid (e.g., a processing bag containing a biological fluid) is exposed to by controlling the on / off times and light intensity of the modular light device 1906. In some examples, the controller 1924 may also control the wavelength of light emitted by the light device and / or the speed of the agitator 1910. In some embodiments, the controller 1924 may be a single-board computer or a custom printed circuit board with a processor. The controller 1924 may include volatile and non-volatile memory.
[0193] In one or more embodiments of the present disclosure, the lighting system 1900 may include one or more smart components 1928. These smart components 1928 may include components such as a modular light device 1906, a controller 1924, a user interface 1918, and a control subsystem 1920, each with its own independent built-in computing hardware. The computing hardware of each smart component can be programmed to perform functions specific to that component. For example, the computing hardware in the controller 1924 can execute algorithms that manage the interactions between all components to perform a treatment process. In some embodiments, the smart component of the light device 1906 may have algorithms for monitoring delivered light (e.g., UV) energy and adjusting treatment time and dose rate. Additionally, the light device 1906 may be capable of receiving instructions and commands from the controller 1924. In some embodiments, the computing hardware of the smart component 1928 can be implemented using custom printed circuit boards, FPGAs, ASICs, and may include volatile and non-volatile memory.
[0194] In one or more embodiments of the present disclosure, the lighting system 1900 can include one or more sensors (not shown). For example, the modular light device 1906 can include a light sensor (e.g., a photodiode) that detects the amount (e.g., total dose) of light (e.g., light energy) emitted by the light source (e.g., exiting an LED) within the light device 1906 and / or the amount of light (e.g., light energy) irradiated onto the biological fluid, e.g., within the treatment vessel. Other examples of sensors include, but are not limited to, proximity sensors, weight sensors, air sensors, temperature sensors, etc.
[0195] In some examples, system 1900 is an electronic device for processing biological fluids, and common interface 1922 is a processing interface of the electronic device. In some examples, a control module of the system (e.g., control module 1016, control module 1916) includes a first controller and a second controller. Via the processing interface, the first controller can be communicatively coupled to multiple non-safety-critical components, such as those described herein, and the second controller can be communicatively coupled to multiple safety-critical components, such as those described herein.
[0196] In some embodiments, in response to communicatively coupling a plurality of non-safety critical components to the processing interface and communicatively coupling a plurality of safety critical components to the processing interface, the system detects, using the control module, the plurality of non-safety critical components and the plurality of safety critical components within the electronic device.
[0197] In some examples, the system can transmit a first message related to the non-safety-critical component between a first controller and a non-safety-critical component via the processing interface, and the system can transmit a second message between a second controller and a safety-critical component via the processing interface. In some embodiments, the first and second messages are based on a domain-specific interface language. For example, the domain-specific interface language is TCP / IP. In some embodiments, in response to receiving the messages, the controller module or component can send a response (e.g., message accepted, message rejected, message missing information, recipient busy) to the sender to confirm receipt of the respective message.
[0198] In some examples, the system determines the state of the non-safety-critical component based on the first message and determines the state of the safety-critical component based on the second message. For example, the state may be one or more of "uninitialized," "initializing," "ready," "running," "calibrating," "shutting down," "in service," and "fault." It is understood that the states are not limited to those described herein.
[0199] In some embodiments, a message may include a message header and message data. The message header may include information related to one or more commands, a transaction number, a message type, and a message size. The message data may include information related to one or more of the conditions described herein.
[0200] In some embodiments, the message may include information about the system. For example, the information about the system may include a throughput associated with the biological fluid being processed, a maximum processing time for the biological fluid, a maximum hold time after processing is complete, a data update interface (e.g., how often the system is notified of processing progress), and component speeds (e.g., agitator current speed (Hz)). It should be understood that the listed information is exemplary and not limiting. In some embodiments, the information in the message is user-defined parameters (e.g., information derived from user-defined processing parameters).
[0201] In some examples, the message can include information about the process. For example, the information about the process can include elapsed time of the process, irradiance, chamber temperature, biological fluid temperature, and component speeds (e.g., agitator current speed (Hz)). It should be understood that the listed information is exemplary and not limiting.
[0202] In some examples, the message may include information to cause the system to cancel execution (e.g., stop processing). In some examples, the message may include information to notify the system that execution has completed (e.g., processing has finished) and data (e.g., statistics) related to the completed processing.
[0203] In some embodiments, the message may be associated with a service of the system. In some examples, the message may be a request to start a service on the system. In some examples, the message includes information about a current service running on the system (e.g., maintenance). In some examples, the message includes information about a completed service (e.g., notifications, service logs).
[0204] In some embodiments, the message may be associated with a system shutdown (e.g., a request to shut down the system, a request to shut down the system at a specific time). In some embodiments, the message may be associated with a system failure (e.g., identification of a failed component, instructions for failure recovery, logs associated with the failure). In some embodiments, the message may be associated with a system calibration (e.g., transfer of a calibration file, transfer of a configuration file). In some embodiments, the message may be associated with a subsystem or component version (e.g., interface version, firmware version, OS version, BIOS version, hardware version, component version, subsystem serial number). For example, a message associated with a subsystem or component version may ensure that the system is up to date with safety, reliability, or compatibility requirements.
[0205] In some examples, a non-safety-critical component or a safety-critical component may change state. For example, the non-safety-critical component or the safety-critical component is in a first state. The system may change the state of the non-safety-critical component or the safety-critical component from the first state to a second state (e.g., in response to user input). In some examples, in response to the change in state, the system sends a second message (e.g., different from the first message) from the non-safety-critical component or the safety-critical component to the control module via the common interface. In some embodiments, the system receives the second message at the first controller or the second controller, and in response to receiving the second message, the system determines a second state of the processing component.
[0206] In some examples, power is applied to the system and the presence of a number of non-safety critical components and a number of safety critical components is detected in response to the application of power to the system, for example, at power up and system initialization.
[0207] In some examples, in response to the system being powered on, the system assigns local network addresses (e.g., IP addresses, MAC addresses) and ports (e.g., TCP ports) to the plurality of non-safety-critical components and the plurality of safety-critical components. In some embodiments, the local network addresses and ports are based on a domain-specific interface language. For example, the local addresses may be IP addresses or MAC addresses, and the local ports may be TCP ports.
[0208] FIG. 20 shows an exemplary system diagram of a system for treating a biological fluid according to an embodiment of the present disclosure. The example system 2000 of FIG. 20 can serve as an additional exemplary system diagram with respect to the embodiment provided above with respect to FIG. 19. In one or more embodiments, the system 2000 can include a user interface controller 2002 that can interface with one or more non-safety critical components of the device. In one or more embodiments, the non-safety critical components can include a display (e.g., a touch display) 2008, a scanner (e.g., a barcode scanner) 2010, an Ethernet port 2012, and one or more USB ports 2014. Non-safety critical components can refer to components in the system 2000 that do not directly interact with one or more biological fluids being treated by the device and whose operation does not substantially affect the safety and effectiveness of the treatment process.
[0209] In one or more embodiments, the UIC 2002 can control and interact with one or more components of the system accessible by an external user of the device. For example, in one or more embodiments, the UIC 2002 can be configured to display one or more graphical user interfaces and can interact with a touch display 2008 configured to receive one or more touch inputs from a user. In one or more embodiments, the UIC 2002 can control or interact with one or more barcode scanners 2010 configured to scan one or more barcodes associated with the biological fluid (e.g., on a container associated with the biological fluid) that contain identifying information about the biological fluid. In one or more embodiments, the UIC 2002 can interact with an Ethernet port 2012 that can be configured to allow the device to connect to an external computing network (e.g., the Internet or an enterprise computing system), such that the device can be externally controlled or accessed by a computer connected to the device via the Ethernet port 2012. In one or more embodiments, the UIC 2002 can be configured to control and interact with one or more universal serial bus (USB) ports 2014. The USB port 2014 may allow external devices such as a mouse or keyboard to be connected to the system 2000 .
[0210] In one or more embodiments, the UIC 2002 can interact with one or more externally facing components (i.e., components that can be controlled by a user or device that is not part of the system), but does not allow a user or device to directly control one or more safety-critical components 2018 of the device. As described in more detail below, the UIC 2002 can communicate with a control system board (CSB) 2006 that can be configured to receive commands from the UIC 2002 and translate those commands into one or more actions that are performed by one or more safety-critical components 2018.
[0211] In one or more embodiments of the present disclosure, the system 2000 can include a network switch 2004 that can route transmissions between components of the system by receiving data using packet switching and forwarding it to specific components in the system. In one or more embodiments, the network switch 2004 can be configured to receive one or more packets (containing commands or information) from the UIC 2002 to the CSB 2006. For example, the UIC 2002 can receive one or more inputs from an external user via the touch display 2008 and then transmit those commands to the CSB 2006 via the network switch 2004 so that the CSB 2004 can control safety-critical components of the device based on the user's input. In one or more embodiments, the network switch 2004 can also receive one or more packets from the CSB 2004 and route the one or more packets to one or more safety-critical components 2018 (associated with a processing module that can include both processing chambers 2020 and 2022) to operate the safety-critical components for the processing of biological fluids in the processing chambers 2020 and 2022.
[0212] As briefly described above, each of the processing chambers 2020 and 2022 can include one or more safety-critical components 2018. The safety-critical components 2018 may refer to the sensors and hardware used by the device to process one or more biological fluids. In one or more embodiments, the safety-critical components included within each processing chamber include a modular light device module 2024, a temperature sensor 2026, a platform (e.g., drawer) latch sensor 2028, a set detect sensor 2030, a tray position sensor 2032, a platform (e.g., drawer) 2034, a platform (e.g., drawer) lock 2036, and an agitator 2038.
[0213] In one or more embodiments, the modular light device module 2024 includes one or more light sources (e.g., UV light sources) and light sensors and is configured to deliver light (e.g., UV light) to the biological fluid as well as monitor the amount of light irradiated onto and / or received by the biological fluid. In one or more embodiments of the present disclosure, the safety-critical component 2018 can include an agitator that can be configured to agitate the contents of the processing vessel to distribute (e.g., evenly distribute) the biological fluid and / or pathogen inactivation compound within the biological fluid (e.g., in a mixture). In one or more embodiments, the agitator 2038 can include a mechanical agitator (e.g., motor, servo) configured to agitate the biological fluid or the photoactive pathogen inactivation compound within the biological fluid (e.g., in a mixture). In one or more embodiments, the safety-critical component can include a platform (e.g., drawer) lock 2036 configured to lock or unlock (i.e., prevent the platform (e.g., drawer) from opening) the processing chamber platform (e.g., drawer) based on a command from the CSB 2006.
[0214] The safety-critical components 2018 may further include a plurality of sensors configured to provide information regarding the operation of the apparatus to the CSB 2006. In one or more embodiments, the temperature sensor 2026 may be configured to monitor the temperature of the system and / or the biological fluid and may be configured to send updates to the CSB 2006 indicating the temperature of the biological fluid and / or the apparatus. In one or more embodiments of the present disclosure, the platform (e.g., drawer) latch sensor 2028 may be configured to detect whether a latch (e.g., lock) on a platform (e.g., drawer) of the apparatus (described in detail above) is in an open or closed position and may be configured to send a signal indicative of the position of the latch to the CSB 2006. In one or more examples, the set (e.g., processing set, fluid processing set) detector sensor 2030 may be configured to detect whether a vessel (e.g., bag) containing a biological fluid is present on or in the platform (e.g., drawer, associated tray) and / or in the processing chamber and may be configured to send a signal indicative of their presence or absence in the vessel (e.g., bag) to the CSB 2006. In one or more embodiments of the present disclosure, the tray position sensor 2032 can be configured to determine the presence of a tray and / or the position of a tray in the apparatus (as described in detail above), e.g., the position (e.g., movement) of the tray within the tray and / or platform (e.g., drawer), and can be configured to send a signal indicative of the platform / tray / drawer position to the CSB 2006. In one or more embodiments, the platform (e.g., drawer) and / or associated sensor 2034 can be configured to determine the position of the platform (e.g., drawer) in the processing chamber (e.g., determine whether the platform (e.g., drawer) is in a closed position within the processing chamber), and can be configured to send a signal indicative of the drawer position to the CSB 2006.In one or more examples, a "tray" can refer to a removable portion or component of a platform that contains a biological fluid during processing, which can be transparent (e.g., fully or partially transparent to allow light to pass through) on one or more surfaces, such as the floor (e.g., bottom) of the tray. In one or more examples, the term "drawer" can refer to a platform and associated frame that holds the tray and to which an agitator motor can be secured. In one or more examples, the drawer can be configured to present the tray to an operator. In one or more examples, the tray can be agitated during processing, such as by moving it linearly back and forth within the platform (e.g., drawer).
[0215] In one or more embodiments of the present disclosure, the CSB 2006 can be configured to communicate directly with the power button of the device to turn the device on or off, and subsequently issue commands to each of the safety-critical components 2018 to stop or start operation. The system 2000 can also include a power supply 2040 that can be used to provide electrical signals to each of the components in the system 2000 to power their operation.
[0216] As shown in FIG. 20 , the system 2000 may include two separate controllers, a UIC 2002 and a CSB 2006, for controlling the non-safety-critical and safety-critical components 2018, respectively. By including two separate controllers, the system 2000 may minimize the impact that unauthorized or erroneous operation of the equipment from an external user or device could have on the operation of the safety-critical components 2018. To further isolate the safety-critical components, for the non-safety-critical components, the UIC 2002 may be configured to communicate with the non-safety-critical components in a first communication protocol, and the CSB 2006 may communicate with the safety-critical components in a second communication protocol that is different from the first communication protocol. In one or more embodiments, the system 2000 may further utilize a domain-specific communication protocol specific to the system to communicate with and command the safety-critical components 2018. In the embodiment of FIG. 20 , the domain-specific communication protocol may be referred to as a processing module interface (TMI) protocol.
[0217] In one or more embodiments, the TMI protocol can be configured so that safety-critical components only respond to commands sent from the CSB 2006. In this way, the UIC 2002, which is configured to control all of the externally facing components (i.e., components accessible to external users or devices), cannot be used to directly control the safety-critical components 2018, thereby adding an extra layer of security to the process. Thus, in one or more embodiments, when a user enters input into one of the non-safety-critical components, such as the touch display 2008, and the command requires an action from one of the safety-critical components 2018, the command can be sent from the UIC 2002 to the CSB 2006 through the network switch 2004. In one or more embodiments, the network switch 2004 is optional and may not be required. Once the CSB 2006 receives the desired action from the UIC 2002, the TMI protocol can be used to generate one or more commands for the safety-critical components 2018 to operate those components according to the desired action registered by the UIC 2002.
[0218] To facilitate the above interactions, the TMI protocol, in one or more embodiments, can be configured to identify the sender / originator of any packet so that the receiver of the packet can determine whether the command was issued from the CSB 2006. In one or more embodiments of the present disclosure, the TMI protocol can be configured to only allow commands originating from the CSB 2006 to act on the safety-critical components 2018. Thus, components that are considered safety-critical can be configured to only accept TMI packets from the CSB 2006.
[0219] In one or more embodiments, the TMI protocol can be configured as a custom communication interface that can serve as a message and command transfer between the CSB2006 and components of the processing module. The TMI can be configured to support safety and cybersecurity (as described above) by separating non-safety-critical and safety-critical functions. In addition to supporting safety, the TMI protocol can also be configured to enable modularity and scalability of the device, improving device reliability and testability. In one or more embodiments, the TMI protocol can utilize Ethernet, UDP / IP transport media to relay protocol-driven communications.
[0220]
[00130] Figure 21 illustrates an exemplary implementation of a domain-specific communication protocol according to an embodiment of the present disclosure. The exemplary diagram 2100 in Figure 21 illustrates the process by which a command issued by an external user is translated into one or more commands used to operate individual components of an electronic device for processing a biological fluid.
[0221] In one or more embodiments, the process shown in diagram 2100 can begin with a user 2102 issuing a command to the device to begin processing a biological fluid. In one or more embodiments, the user 2102 can issue a command 2116 via a user interface 2104. The user interface 2104 can include a display (e.g., a touchscreen display), a voice recognition component, a motion detection component, a keyboard, or any other device configured to allow a user to input their desired actions into an electronic device so that the device can act based on those commands.
[0222] In one or more embodiments, when user interface 2104 receives command 2116 from user 2102, user interface 2104 can convert the user's command into a specially formatted command 2118 that is compatible with user interface controller (UIC) 2106 (as described in more detail above). Upon receiving command 2118, UIC 2106 can process and validate the command, as shown at 2120. If command 2118 received by the UIC is successfully validated (i.e., the command is proper and, in one or more embodiments, authenticated), UIC 2106 can send signal 2122 to user interface 2104, which causes user interface 2104 to provide an indication to user 2102 via interface 2104 that the process has been successfully initiated.
[0223] In one or more embodiments, after processing and validating the received command 2118, the UIC 2106 can generate and send a command 2124 formatted using the domain-specific TMI communication protocol (described above with respect to FIG. 20 ) configured to alert the system controller 2108 to the user's desired electronic device operation. In one or more embodiments, the TMI protocol-formatted command 2124 can include information about the sender of the command 2124 (in this case, the UIC 2106), and the system controller can be configured to only accept commands sent by the UIC 2106 that initiate an operation. Once the system controller 2108 receives the TMI-formatted message 2124 from the UIC 2106, the system controller 2108 can process and validate the command, as shown at 2126.
[0224] In one or more embodiments, once the system controller 2108 processes and validates the TMI-formatted message 2124 from the UIC 2106 at 2126, the system controller can generate and send one or more commands to each of the components 2110, 2112, and 2114 to initiate the biological fluid treatment process. In one or more embodiments, the components 2110, 2112, and 2114 can represent safety-critical components located within the processing chamber of the device and, in one or more embodiments, can include light system components, agitators, platform / tray / drawer locks, and sensors discussed in detail above with respect to FIG. 12 . In one or more embodiments, the system controller can generate separate commands 2128, 2132, and 2136 for each of the components 2110, 2112, and 2114 that may be involved in the processing of the biological fluid. In one or more embodiments, the commands 2128, 2132, and 2136 can be formatted using a domain-specific TMI communication protocol known only to the components within the electronic device. Additionally, commands 2128, 2132, and 2136 generated using the TMI communication protocol may include information regarding the origin of the command (in this case, system controller 2108), and each of components 2110, 2112, and 2114 may be configured to respond only to commands determined to have originated from system controller 2108.
[0225] In one or more embodiments, the system controller 2108 can generate a TMI message 2128 to a first component in the process chamber 2110 indicating the action the component should take and identifying the origin of the message. Once the first component 2110 receives the command 2128, it can process and validate the command in 2130 to ensure not only that the command is appropriate, but that it originated from the system controller 2108. If the component 2110 determines that the command 2128 is inappropriate or cannot determine that the command 2128 originated from the system controller 2108, the component can send a message to the system controller 2108 alerting the system controller 2108 of the error (not shown). However, if the command is properly validated and authenticated, in one or more embodiments, the component 2110 can perform the action indicated by the message 2128. Once the component 2110 performs the action, it can generate a message 2144 formatted using the TMI protocol that informs the system controller 2108 that the requested action has been performed.
[0226] In one or more embodiments, the system controller 2108 can generate a TMI message 2132 to a second component of the process chamber 2112 indicating the action the component should take and identifying the origin of the message. Once the second component 2112 receives the command 2132, it can process and validate the command at 2134 to ensure not only that the command is appropriate, but that it originated from the system controller 2108. If the component 2112 determines that the command 2132 is inappropriate or cannot determine that the command 2132 originated from the system controller 2108, the component 2112 can send a message to the system controller 2108 alerting it to the error (not shown). However, if the command is properly validated and authenticated, in one or more embodiments, the component 2112 can perform the action indicated by the message 2132. Once the component 2112 performs the action, it can generate a message 2140 formatted using the TMI protocol that informs the system controller 2108 that the requested action has been performed.
[0227] In one or more embodiments, the system controller 2108 can generate a TMI message 2136 to the process chamber's third component 2114 indicating the action the component should take and identifying the origin of the message. Once the third component 2114 receives the command 2136, it can process and validate the command at 2138 to ensure not only that the command is appropriate, but that it originated from the system controller 2108. If the component 2114 determines that the command 2136 is inappropriate or cannot determine that the command 2136 originated from the system controller 2108, the component 2114 can send a message (not shown) to the system controller 2108 alerting it to the error. However, if the command is properly validated and authenticated, in one or more embodiments, the component 2114 can perform the action indicated by the message 2136. Once the component 2114 performs the action, it can generate a message 2142 formatted using the TMI protocol that informs the system controller 2108 that the requested action has been performed.
[0228] While the example of Figure 21 illustrates a communication process for a device including three components 2110, 2112, and 2114, this example can be readily applied to a device having any number of components without deviating from the methods and processes described above with respect to Figure 21. 21. Thus, components 2110, 2112, and 2114 are for illustrative purposes and should not be considered limiting.
[0229] In one or more embodiments, when system controller 2108 receives messages 2140, 2142, and 2144 from components 2110, 2112, and 2114, system controller 2108 may process and validate the received messages at 2146, and may then generate and send a TMI-formatted message 2148 to UIC 2106 indicating that processing has finished (e.g., processing is complete). In one or more embodiments, upon receiving message 2148 from system controller 2108 indicating that processing has finished, the UIC may send message 2150 (either in TMI format or another format understood by the display) to user interface 2104, instructing the user interface to display one or more graphical user interfaces indicating to the user that the processing process has finished.
[0230] As demonstrated above with respect to the embodiment of FIG. 21 , an apparatus can be configured to use a domain-specific TMI communication protocol to provide isolation between components controlled by the UIC 2106 and components controlled by the system controller 2108. By configuring the TMI protocol so that safety-critical components used to process biological fluids can only accept commands generated by the TMI protocol (which are recognized only internally by the apparatus) and not by the system controller 2108, the ability of a malicious user or other external actor to command the apparatus without authorization is minimized. In one or more embodiments, the TMI communication protocol can further be configured to facilitate the introduction of new or replacement components in a processing chamber with minimal disruption to the apparatus, since the system controller can detect the new components and ensure that only it can issue commands to operate them.
[0231] In one or more embodiments, the TMI communication protocol can serve as a message and command transport between the controller 2108 and components located within each processing chamber. The TMI communication protocol can support the safety and cybersecurity needs of the device by separating and isolating safety-critical components from non-safety-critical components, enabling modularity and scalability, and improving reliability and testability. In one or more embodiments, the TMI communication protocol can be configured using a state-based design that reduces design complexity, reduces changes due to misuse, isolates errors between components, and reports events to the device in an efficient manner. In one or more embodiments, the TMI communication protocol can utilize commercially available transport protocols, such as Ethernet or UDP / IP, to transport messages back and forth between the various components of the device.
[0232] 22 illustrates an exemplary method 2200 of operating an exemplary system for treating a biological fluid according to embodiments of the present disclosure. In some embodiments, method 2200 can be performed using a device or system disclosed herein.
[0233] Method 2200 includes coupling a non-safety critical component or a safety critical component to a processing interface (step 2202). For example, with reference to Figures 18 and 19, one of the non-safety critical components or the safety critical components is communicatively coupled to common interface 1822 or 1822.
[0234] The method includes detecting, using the controller, the presence of a non-safety-critical or safety-critical component of the electronic device in response to coupling of the non-safety-critical or safety-critical component to the processing interface (step 2204). For example, with reference to Figures 18 and 19, the presence of a non-safety-critical or safety-critical component is detected in response to the coupling performed in step 2202.
[0235] The method includes transmitting messages based on a domain-specific interface language between the controller and the non-safety-critical or safety-critical components via the processing interface (step 2206). For example, with reference to Figures 18 and 19, messages are transmitted between a coupling component and a controller module as disclosed herein.
[0236] The method includes determining a state of the non-safety-critical or safety-critical component based on the message (step 2208). For example, with reference to Figures 18 and 19, a state of the coupling component disclosed herein is determined based on the message sent in step 2206.
[0237] Although the common interface is described with respect to a system including multiple non-safety-critical and safety-critical components, it is understood that the above description is also applicable to individual non-safety-critical or individual safety-critical components. For example, a system may include a control module, a non-safety-critical component, a safety-critical component, and a common interface (e.g., a processing interface of an electronic device for processing biological fluids). Interactions between the control module and the non-safety-critical or safety-critical components using the common interface may be substantially similar to the common interface interactions between the control module, the non-safety-critical component, and the safety-critical component described herein. For brevity, interactions between the control module and the non-safety-critical or safety-critical components will not be described. It is understood that all such variations are within the scope of the present disclosure.
[0238] FIG. 23 illustrates an example of a computing device according to one embodiment. The device 2300 may be a host computer connected to a network. The device 2300 may be a client computer or a server. As illustrated in FIG. 23, the device 2300 may be any suitable type of microprocessor-based device, such as a personal computer, a workstation, a server, or a handheld computing device (portable electronic device) such as a phone or tablet. The device may include, for example, one or more of a processor 2302, input device(s) 2306, output device(s) 2308, storage 2310, and communication device(s) 2304. The input device(s) 2306 and output device(s) 2308 may generally correspond to those described above and may be connectable to or integrated into the computer.
[0239] Input device(s) 2306 may be any suitable device that provides input, such as a touchscreen, a keyboard or keypad, a mouse, or a voice recognition device. Output device(s) 2308 may be any suitable device that provides output, such as a touchscreen, a tactile device, or a speaker.
[0240] Storage 2310 may be any suitable device for providing storage, such as RAM, cache, electrical, magnetic, or optical memory, including a hard drive or removable storage disk. Communications device 2304 may include any suitable device capable of sending and receiving signals over a network, such as a network interface chip or device. The components of the computer may be connected in any suitable manner, for example, via a physical bus or wirelessly.
[0241] The software 2312 that may be stored in the storage 2310 and executed by the processor 2310 may include, for example, programming that embodies the functions of the present disclosure (e.g., embodied in the devices described above).
[0242] The software 2312 may also be stored and / or transported in any non-transitory computer-readable storage medium for use by or in connection with an instruction execution system, apparatus, or device that can retrieve and execute instructions associated with the software, such as those described above. In the context of this document, a computer-readable storage medium may be any medium that can contain or store a program for use by or in connection with an instruction execution system, apparatus, or device, such as storage 2310.
[0243] The software 2312 may also be propagated in any transport medium for use by or in connection with an instruction execution system, apparatus, or device, such as those described above, that can retrieve and execute instructions associated with the software from an instruction execution system, apparatus, or device. In the context of this disclosure, a transport medium may be any medium that can communicate, propagate, or transport programming for use by or in connection with an instruction execution system, apparatus, or device. Transport-readable media include, but are not limited to, electronic, magnetic, optical, electromagnetic, or infrared wired or wireless propagation media.
[0244] The device 2300 may be connected to a network, which may be any suitable type of interconnected communications system. The network may implement any suitable communications protocol and may be protected by any suitable security protocol. The network may include any suitable configuration of network links capable of implementing the transmission and reception of network signals, such as a wireless network connection, a T1 or T3 line, a cable network, DSL, or a telephone line.
[0245] The device 2300 may implement any operating system suitable for operation over a network. The software 2312 may be written in any suitable programming language, such as C, C++, Java, or Python. In various embodiments, application software embodying functionality of the present disclosure may be deployed in different configurations, such as, for example, in a client / server configuration or as a web-based application or web service via a web browser.
[0246] In one aspect, an electronic device for processing a biological fluid includes a plurality of non-safety critical components; a first controller communicatively coupled to the plurality of non-safety critical components and configured to operate the plurality of non-safety critical components; a plurality of safety critical components including one or more platforms, each platform of the one or more platforms configured to carry one or more biological fluids; one or more modular light devices, each light device configured to irradiate a biological fluid; and one or more safety components configured to monitor operation of the safety critical components; and a second controller communicatively coupled to the plurality of safety critical components and to the first controller and configured to coordinate one or more operations involving the plurality of safety critical components, wherein the first controller and the second controller communicate with each other using a domain-specific interface language configured to separate the plurality of non-safety critical components from the plurality of safety critical components.
[0247] While specific components, configurations, features, and functions have been provided above, those skilled in the art will recognize that other variations may be used. Additionally, while features may appear to be described in connection with particular embodiments, those skilled in the art will recognize that various features of the described embodiments may be combined. Furthermore, aspects described in connection with one embodiment may be used alone.
[0248] In some embodiments, any of the processing systems and devices described above can be used to inactivate pathogen(s) in one or more biological fluids, including, for example, biological fluids mixed with a pathogen inactivation compound (e.g., a photoactive pathogen inactivation compound, psoralen). Specifically, any of the processing systems and devices described above can irradiate a mixture of one or more pathogen inactivation compounds and a biological fluid, such as, for example, blood or a blood product (e.g., a platelet composition, a plasma composition, and derivatives thereof), with light of a certain wavelength (e.g., ultraviolet light) to cause a photochemical reaction that inactivates pathogen(s), such as viruses, bacteria, parasites, and other contaminants, including, for example, cellular contaminants (e.g., white blood cells), that may be present in the biological fluid. In some embodiments, the pathogen inactivation compounds target nucleic acids to photochemically form adducts and / or crosslinks. For example, the disclosed device can be used in a method for treating a biological fluid, the method including providing a biological fluid mixed with a photoactive pathogen inactivation compound (e.g., psoralen, amotosalen) and irradiating the biological fluid with ultraviolet light, e.g., ultraviolet light, having a first peak wavelength of about 315 nm to about 350 nm (e.g., about 315 nm to about 335 nm, about 330 nm to about 350 nm, about 340 nm to about 350 nm, about 340 nm, about 345 nm) emitted by a set of one or more first light sources, the irradiating the biological fluid occurring for a duration and intensity sufficient to inactivate pathogens in the biological fluid. In some examples, the disclosed device can be used in a method for treating a biological fluid, the method including irradiating the biological fluid with ultraviolet light (e.g., UV-A, UV-B, UV-C) emitted by one or more first light sources, the irradiating the biological fluid occurring for a duration and intensity sufficient to inactivate pathogens in the biological fluid. In some embodiments, each of the one or more first light sources emits light having a full width half maximum (FWHM) spectral bandwidth of less than 20 nanometers. In some embodiments, each of the one or more first light sources is a light emitting diode (LED).
[0249] The term "pathogen inactivating compound" refers to any suitable compound, e.g., a small molecule organic compound, that can be used to inactivate pathogens that may be present in biological fluids, such as, for example, blood or blood products. Pathogen inactivating compounds that are "photoactive" or "light-activated" or "photochemical" or "photosensitizing" compounds are suitable compounds that require some level of light to fully inactivate pathogens. Such compounds are preferred for inactivating pathogens in biological products because they provide control over the inactivation process. In some embodiments, the pathogen inactivating compound is a photoactive pathogen inactivating compound selected from the group consisting of psoralens, isoalloxazines, alloxazines, phthalocyanines, phenothiazines, porphyrins, and merocyanine 540. In some embodiments, the pathogen inactivating compound is a psoralen. In some embodiments, the pathogen inactivating compound is amotosalen (e.g., S-59). Such photoactivated or photochemical pathogen inactivating compounds described herein can include, but are not limited to, psoralens, isoalloxazines, alloxazines, phthalocyanines, phenothiazines, and porphyrins, where these terms are understood to encompass the general class of compounds, i.e., the core compound and suitable derivatives thereof. For example, psoralens or singular generally refers to a psoralen core compound and any derivatives thereof (e.g., amotosalen), isoalloxazines or singular generally refers to an isoalloxazine core and any derivatives thereof (e.g., riboflavin), etc. Such derivatives include the core compound structure and additional substituents on the core. Description of such compounds includes any salts thereof.
[0250] The term "amotosalen" refers to the compound 3-(2-aminoethoxymethyl)-2,5,9-trimethylfuro[3,2-g]chromen-7-one and any salts thereof. This compound may also be referred to as 4'-(4-amino-2-oxa)butyl-4,5',8-trimethylpsoralen. When the methods of the present disclosure involve adding amotosalen HCl (the HCl salt of amotosalen), removal of this compound from biological fluids, such as blood products (e.g., platelet compositions, platelet units, plasma compositions, whole blood compositions, plasma compositions), is not limited to removal of amotosalen HCl, as amotosalen may be present in solution as other salts or the free base. As used in the methods described herein, removal of amotosalen refers to removal of this compound in any form, such as the free base or any salt, as measured by the assays described herein.
[0251] In some embodiments, the pathogen inactivating compound is a 4-primaryamino-substituted psoralen, which is a psoralen compound having an NH group linked to the 4' position of the psoralen by a hydrocarbon chain having a total length of 2-20 carbons, where 0-6 of these carbons are independently replaced by NH or O, with each point of replacement being at least 2 carbons away from each other and at least 1 carbon away from the psoralen. 4'-primaryamino-substituted psoralens may have additional substitutions at the 4, 5', and 8 positions of the psoralen, including, but not limited to, the following groups: H and (CH) n CH3, where n=0-6. In some embodiments, the 4'-primary amino substituted psoralen is a) -(CH2) u -NH2, -(CH2) w -R2-(CH2) z -NH2, -(CH2) w -R2-(CH2) x -R3-(CH2)z-NH2, and -(CH2) w -R2-(CH2) x -R3-(CH2) y -R4-(CH2) za substituent R1 on the 4' carbon atom selected from the group including -NH2 (wherein R2, R3, and R4 are independently selected from the group including O and NH, u is an integer from 1 to 10, w is an integer from 1 to 5, x is an integer from 2 to 5, y is an integer from 2 to 5, and z is an integer from 2 to 6); and b) H and (CH2) v and R5, R6, and R7 (wherein v is an integer from 0 to 5) substituents on the carbon atoms at positions 4, 5', and 8, respectively, independently selected from the group comprising CH3 or a salt thereof.
[0252] In some embodiments, the pathogen inactivating compound is a 5-primaryamino-substituted psoralen, which is a psoralen compound having an NH group linked to the 5' position of the psoralen by a hydrocarbon chain having a total length of 1-20 carbons, where 0-6 of these carbons are independently replaced by NH or O, with each point of replacement being at least 2 carbons away from each other and at least 1 carbon away from the psoralen. 5'-primaryamino-substituted psoralens may have additional substitutions at the 4, 4', and 8 positions of the psoralen, including, but not limited to, the following groups: H and (CH) n CH3, where n=0-6. In some embodiments, the 5'-primary amino substituted psoralen is a) -(CH2) u -NH2, -(CH2) w -R2-(CH2) z -NH2, -(CH2) w -R2-(CH2) x -R3-(CH2)z-NH2, and -(CH2) w -R2-(CH2) x -R3-(CH2) y -R4-(CH2) z a substituent R1 on the 5' carbon atom selected from the group including -NH2 (wherein R2, R3, and R4 are independently selected from the group including O and NH, u is an integer from 1 to 10, w is an integer from 1 to 5, x is an integer from 2 to 5, y is an integer from 2 to 5, and z is an integer from 2 to 6); and b) H and (CH2) vsubstituents R5, R6, and R7 on the 4, 4', and 8 carbon atoms, respectively, independently selected from the group comprising: CH3 or a salt thereof, where v is an integer from 0 to 5, and R1 is -(CH2) u When selected from the group containing —NH, R is (CH) v CH3, and R5, R6, and R7 are (CH 2 ) v When psoralen is CH3, u is an integer from 3 to 10. Exemplary psoralen compounds are described, for example, in U.S. Pat. No. 5,593,823.
[0253] In some embodiments, the biological fluid is mixed with a pathogen inactivating compound (PIC) in a platelet additive solution (PAS). In some embodiments, the PIC is mixed with the PAS before mixing with the biological fluid. The platelet additive solution may be prepared using a method such as those described, for example, in Alhumaidan et al. and Ringwald et al. (Alhumaidan, H. and Sweeney, J., J Clin Apheresis, 27: 93-98 (2012); Ringwald et al., Transfusion Medicine Reviews, 20: 158-64 (2006), which are incorporated herein by reference in their entireties. In some embodiments, the platelet additive solution (PAS) comprises one or more of chloride, acetate, citrate, potassium, magnesium, phosphate, gluconate, glucose, and bicarbonate. In some embodiments, the platelet additive solution (PAS) is a PAS approved by a regulatory agency or a certification body generally accepted in the art.
[0254] In some embodiments, the method further comprises agitating the biological fluid. In some embodiments of any of the methods provided herein, the total dose of ultraviolet light irradiating the biological fluid (e.g., emitted by one or more light sources, emitted by one or more sets of light sources, emitted by a light source array) is about 0.5 J / cm2 ~about 50J / cm 2 , for example, about 0.5 J / cm 2 ~about 10J / cm 2 , about 0.5J / cm 2 ~About 15J / cm 2 , about 0.5J / cm 2 ~About 25J / cm 2 , about 1J / cm 2 ~about 10J / cm 2 , about 1J / cm 2 ~About 15J / cm 2 , about 1J / cm 2 ~About 25J / cm 2 , about 3J / cm 2 ~about 10J / cm 2 , about 3J / cm 2 ~About 15J / cm 2 , about 3J / cm 2 ~About 25J / cm 2 , about 5J / cm 2 ~about 10J / cm 2 , about 5J / cm 2 ~About 15J / cm 2 , about 5J / cm 2 ~About 25J / cm 2 , about 10J / cm 2 ~About 30J / cm 2 , about 10J / cm 2 ~About 20J / cm 2 , about 15J / cm 2 ~about 50J / cm 2 , about 15J / cm 2 ~About 35J / cm 2 , about 20J / cm 2 ~About 30J / cm 2 , about 25J / cm 2 ~about 50J / cm 2 , about 30J / cm 2 ~about 40J / cm 2 , or about 40 J / cm 2 ~about 50J / cm 2 In some embodiments, the total dose of ultraviolet light applied to the biological fluid is about 0.5 J / cm 2 More than, for example, approximately 1 J / cm 2 More than 2J / cm 2 More than 3J / cm2 More than 4J / cm 2 More than 5J / cm 2 More than 6J / cm 2 More than 7J / cm 2 More than 8J / cm 2 Above, 9J / cm 2 More than 10J / cm 2 More than 15J / cm 2 Above, 20J / cm 2 Above, 25J / cm 2 Above, 30J / cm 2 Above, 35J / cm 2 Above, 40J / cm 2 Above, 45J / cm 2 or more than 50J / cm 2 In some embodiments, the total dose of ultraviolet light applied to the biological fluid is about 50 J / cm 2 Less than 40J / cm 2 Less than 30J / cm 2 Less than 25J / cm 2 Less than 20J / cm 2 Less than 15J / cm 2 Less than or about 10J / cm 2 In some embodiments, irradiating the biological fluid occurs for a duration and intensity sufficient to inactivate pathogens in the biological fluid (e.g., if present in the biological fluid). For example, in some embodiments, irradiating the biological fluid occurs for a duration and intensity (e.g., any suitable combination of duration and intensity sufficient to provide a total dose of ultraviolet light) to irradiate the biological fluid (e.g., a desired total dose, a given total dose, or a total dose as described above). In some embodiments, the intensity is between 1 and 1000 mW / cm. 2 (e.g., 1 to 100 mW / cm 2 In some embodiments, the period is between 1 second and 2 hours (eg, between 1 minute and 60 minutes).
[0255] It should be understood that treating a biological fluid to inactivate potentially present pathogen(s) does not necessarily result in complete inactivation of all potentially present pathogens, but rather a substantial reduction in the amount of pathogens to significantly reduce risks arising from the presence of the pathogens (e.g., infections associated with administration of pathogen-contaminated biological fluids, transfusion-associated illnesses from blood products, and infections transmitted through transfusions of blood products). Pathogen inactivation can be assayed by measuring the number of infectious pathogens (e.g., virus particles, bacteria) in a specific volume, and the level of inactivation is typically expressed as a log reduction in infectivity of the pathogen, i.e., a log reduction in titer. Methods for assaying and measuring a log reduction in titer to assess the level of pathogen inactivation are well known in the art. In some embodiments, the treating system, device, and / or method is sufficient to inactivate at least 1 log (e.g., at least 2 log, at least 3 log, at least 4 log, or more) of the pathogen in the biological fluid when present. In some embodiments, the biological fluid after irradiation is suitable for injection into a subject without further processing to remove residual pathogen inactivating compound or its photoproduct(s). In some embodiments, the systems, devices, and / or methods for treating are sufficient to inactivate at least 1 log (e.g., at least 2 logs, at least 3 logs, at least 4 logs, or more) of pathogens in the biological fluid when present, and the biological fluid comprises 10 μM or less of the pathogen inactivating compound after irradiating the biological fluid. In some embodiments, the systems, devices, and / or methods for treating are sufficient to inactivate at least 1 log (e.g., at least 2 logs, at least 3 logs, at least 4 logs, or more) of pathogens in the biological fluid when present, and the biological fluid comprises 7.5 μM or less of the pathogen inactivating compound after irradiation.In some embodiments, the systems, devices, and / or methods for treating are sufficient to inactivate at least 1 log (e.g., at least 2 log, at least 3 log, at least 4 log, or more) of pathogens in the biological fluid when present, and the biological fluid contains 5 μM or less (e.g., 4 μM or less, 3 μM or less, 2 μM or less, 1 μM or less, 0.5 μM or less) of the pathogen inactivating compound after irradiation. In some embodiments, the concentration of the pathogen inactivating compound mixed with the biological fluid before irradiation is at least about 10 μM (e.g., at least about 30 μM, at least about 60 μM, at least about 90 μM, at least about 110 μM). In some embodiments, the concentration of the pathogen inactivating compound mixed with the biological fluid before irradiation is between about 15 μM and about 150 μM (e.g., at least about 30 μM to about 110 μM, about 60 μM to about 90 μM, about 75 μM). In some embodiments, the concentration of the pathogen inactivating compound mixed with the biological fluid after irradiation is at most one-third of the concentration of the pathogen inactivating compound mixed with the biological fluid before irradiation. In some embodiments, the biological fluid after irradiation maintains sufficient biological activity, such that the biological fluid is suitable for infusion into a subject. In any of the above embodiments, the biological fluid can be a blood product (e.g., platelets, plasma).
[0256] In some aspects of the above apparatus, the first controller includes an output port, and the first controller is configured to communicate with an external computing device using the output port.
[0257] In some aspects of the above apparatus, separating the plurality of non-safety-critical components from the plurality of safety-critical components includes configuring a domain-specific interface language to minimize an impact on the plurality of safety-critical components from changes to the one or more non-safety-critical components.
[0258] In some embodiments of the above-described devices, the device further includes one or more processing chambers configured to receive a biological fluid, and each platform of the one or more platforms is configured to be disposed within one of the one or more processing chambers.
[0259] In some embodiments of the above apparatus, the safety-critical components further include one or more agitators, each configured to agitate at least one of the one or more platforms.
[0260] In some aspects of the above apparatus, the safety-critical component further comprises one or more sensors configured to detect light energy from the one or more light devices.
[0261] In some embodiments of the above devices, the one or more modular light devices include one or more light source arrays arranged to illuminate the biological fluid, wherein the one or more light source arrays are configured to emit light in the ultraviolet light spectrum.
[0262] In some embodiments of the above device, the one or more light source arrays include a plurality of light sources, each light source of the plurality of light sources emitting light having a full width half maximum (FWHM) spectral bandwidth of less than 20 nanometers.
[0263] In some embodiments of the above device, the array of one or more light sources comprises a plurality of light sources, and each light source of the plurality of light sources is a light emitting diode (LED).
[0264] In some embodiments of the above device, the array of one or more light sources each includes a respective first light source channel configured to emit ultraviolet light having a first peak wavelength of the array.
[0265] In some embodiments of the above device, each of the array of one or more light sources comprises a first light source channel configured to emit ultraviolet light having a first peak wavelength of about 315 nm to about 350 nm.
[0266] In some embodiments of the above apparatus, the first light source channel comprises one or more light sources each emitting light having a full width half maximum (FWHM) spectral bandwidth of less than 20 nanometers.
[0267] In some embodiments of the above apparatus, the first light source channel includes one or more light sources, and the one or more light sources are light emitting diodes (LEDs).
[0268] In some embodiments of the above device, the one or more light devices further comprise one or more sensors configured to detect light energy from the array of one or more light sources.
[0269] In some embodiments of the above device, the one or more safety-critical components include computing hardware configured to execute one or more algorithms and configured to store information regarding the operation of the electronic device.
[0270] In some embodiments of the above device, the second controller is configured to turn one or more of the safety-critical components on or off based on one or more operating conditions of the device.
[0271] In some aspects of the above apparatus, the one or more safety components are collectively configured to implement a hardware watchdog.
[0272] In some aspects of the above apparatus, the one or more safety components are collectively configured to implement a software watchdog.
[0273] In some embodiments of the above devices, one or more non-safety critical components include a display configured to provide information to and / or receive input from a user of the device.
[0274] In some embodiments of the above-described device, it is used in a method of treating a biological fluid, the method including providing a biological fluid mixed with a pathogen inactivation compound, and irradiating the biological fluid with ultraviolet light having a first peak wavelength of about 315 nm to about 350 nm emitted by a set of one or more first light sources, wherein 1) each of the one or more first light sources emits light having a full width half maximum (FWHM) spectral bandwidth of less than 20 nanometers, or 2) each of the one or more first light sources is a light emitting diode (LED), and the irradiating the biological fluid occurs for a duration and intensity sufficient to inactivate pathogens in the biological fluid.
[0275] In some aspects of the above apparatus, the apparatus further includes a processing interface through which a first controller is communicatively coupled to a plurality of non-safety-critical components and a second controller is communicatively coupled to a plurality of safety-critical components; one or more processors; a memory; and one or more programs stored in the memory and configured to be executed by the one or more processors, wherein the one or more programs are configured to: communicatively couple the plurality of non-safety-critical components to the processing interface; and in response to communicatively coupling the plurality of safety-critical components to the processing interface, detect the presence of the plurality of non-safety-critical components and the plurality of safety-critical components at the controllers; send a first message between the first controller and the non-safety-critical components via the processing interface and send a second message between the second controller and the safety-critical components via the processing interface, the first message and the second message being based on a domain-specific interface language; determine a state of the non-safety-critical components based on the first message and determine a state of the safety-critical components based on the second message.
[0276] In some embodiments of the above apparatus, the non-safety-critical component or the safety-critical component is in a first state, and the one or more programs further include instructions for changing the state of the non-safety-critical component or the safety-critical component, sending a second message from the non-safety-critical component or the safety-critical component via the processing interface to the first controller or the second controller in response to the change in state, receiving the second message at the first controller or the second controller, and determining a second state of the processing component in response to receiving the second message.
[0277] In some embodiments of the above device, the one or more programs further include instructions for supplying power to the electronic device, and in response to supplying power to the electronic device, the presence of a plurality of non-safety-critical components and a plurality of safety-critical components is further detected.
[0278] In some embodiments of the above device, the one or more programs further include instructions for assigning local network addresses and ports to the plurality of non-safety-critical components and the plurality of safety-critical components in response to supplying power to the electronic device, the local network addresses or ports being based on a domain-specific device interface language.
[0279] In some embodiments of the above apparatus, one or more messages written in a domain-specific interface language may be transmitted using TCP / IP.
[0280] In another aspect, a method of treating a biological fluid includes providing the biological fluid mixed with a photoactive pathogen inactivation compound and irradiating the biological fluid with any of the devices described above for a duration and intensity sufficient to inactivate pathogens in the biological fluid.
[0281] In another aspect, a method of operating an electronic device for processing a biological fluid, the electronic device including a controller, a non-safety-critical component, a safety-critical component, and a processing interface, the method including coupling the non-safety-critical component or the safety-critical component to the processing interface, detecting with the controller a presence of the non-safety-critical component or the safety-critical component in the electronic device in response to coupling of the non-safety-critical component or the safety-critical component to the processing interface, sending messages between the controller and the non-safety-critical component or the safety-critical component via the processing interface based on a domain-specific interface language, and determining a state of the non-safety-critical component or the safety-critical component based on the messages.
[0282] In some aspects of the above method, the electronic device further comprises a second controller coupled to the processing interface, wherein the safety-critical component is coupled to the processing interface, and the method includes coupling the non-safety-critical component to the processing interface and isolating the non-safety-critical component from the safety-critical component, wherein the isolating includes configuring the domain-specific interface language to minimize an impact on the safety-critical component of one or more changes to the non-safety-critical component.
[0283] In some aspects of the above method, the non-safety-critical component or the safety-critical component is in a first state, and the method further includes changing the state of the non-safety-critical component or the safety-critical component from the first state to a second state, sending a second message from the non-safety-critical component or the safety-critical component to the controller via the processing interface in response to changing the state, receiving the second message at the controller, and determining a second state of the processing component in response to receiving the second message.
[0284] In some aspects of the above method, the safety-critical component is one of a platform, a light device, an agitator, and a safety component, and the one or more safety components are configured to monitor operation of the safety-critical component.
[0285] In some aspects of the above method, the method further includes isolating the processing interface from external networks using a domain-specific interface language.
[0286] In some aspects of the above method, the method further includes providing power to the electronic device, and the presence of the processing component is further detected in response to providing power to the electronic device.
[0287] In some aspects of the above methods, the method further includes assigning a local network address or port to the non-safety-critical component or the safety-critical component in response to supplying power to the electronic device, the local network address or port being based on the domain-specific interface language.
[0288] In some embodiments of the above method, one or more messages written in a domain-specific interface language may be sent using TCP / IP.
[0289] In another aspect, an electronic device for processing a biological fluid comprises a controller, a non-safety-critical component, a safety-critical component, a processing interface, one or more processors, a memory, and one or more programs, the one or more programs stored in the memory and configured to be executed by the one or more processors, the one or more programs comprising instructions for: in response to coupling of the non-safety-critical component or the safety-critical component to the processing interface, detecting, using the controller, a presence of the non-safety-critical component or the safety-critical component in the electronic device; sending a message based on a domain-specific interface language via the processing interface between the controller and the non-safety-critical component to the processing interface; and determining a state of the non-safety-critical component or the safety-critical component based on the message.
[0290] In another aspect, a non-transitory computer-readable storage medium storing one or more programs, the one or more programs comprising instructions that, when executed by an electronic device with one or more processors and a memory, cause the device to: couple a non-safety-critical component or a safety-critical component to a processing interface; in response to the coupling of the non-safety-critical component or the safety-critical component to the processing interface, detect, using a controller, the presence of the non-safety-critical component or the safety-critical component in the electronic device; send messages between the controller and the non-safety-critical component or the safety-critical component to the processing interface via the processing interface based on a domain-specific interface language; and determine a state of the non-safety-critical component or the safety-critical component based on the messages.
[0291] In some embodiments, the electronic device includes a plurality of non-safety critical components, a first controller communicatively coupled to the plurality of non-safety critical components, a plurality of safety critical components, and a second controller communicatively coupled to the plurality of safety critical components. In some embodiments, the electronic device includes a processing interface.
[0292] In some embodiments, an electronic device for processing a biological fluid includes a plurality of non-safety-critical components; a first controller communicatively coupled to the plurality of non-safety-critical components and configured to operate the plurality of non-safety-critical components; a plurality of safety-critical components including one or more platforms, each platform of the one or more platforms configured to carry one or more biological fluids; one or more light devices, each light device configured to irradiate the biological fluid; and one or more safety components configured to monitor operation of the safety-critical components; and a second controller communicatively coupled to the plurality of safety-critical components and communicatively coupled to the first controller and configured to coordinate one or more operations involving the plurality of safety-critical components, wherein the first controller and the second controller communicate with each other using a domain-specific interface language configured to separate the plurality of non-safety-critical components from the plurality of safety-critical components.
[0293] In some embodiments, the first controller includes an output port, and the first controller is configured to communicate with an external computing device using the output port.
[0294] In some embodiments, separating the plurality of non-safety-critical components from the plurality of safety-critical components includes configuring the domain-specific interface language to minimize impact on the plurality of safety-critical components from changes to the one or more non-safety-critical components.
[0295] In some embodiments, the device further includes one or more processing chambers configured to receive a biological fluid, and each platform of the one or more platforms is configured to be disposed within one of the one or more processing chambers.
[0296] In some embodiments, the safety-critical components further include one or more agitators, each configured to agitate at least one of the one or more platforms.
[0297] In some embodiments, the safety-critical component further comprises one or more sensors configured to detect light energy from the one or more modular light devices.
[0298] In some embodiments, the one or more modular light devices include one or more light source arrays positioned to illuminate the biological fluid, wherein the one or more light source arrays are configured to emit light in the ultraviolet light spectrum.
[0299] In some embodiments, each of the array of one or more light sources comprises a first light source channel configured to emit ultraviolet light having a first peak wavelength between about 315 nm and about 350 nm.
[0300] In some embodiments, the first light source channel comprises one or more light sources, each emitting light having a full width half maximum (FWHM) spectral bandwidth of less than 20 nanometers.
[0301] In some embodiments, the first light source channel includes one or more light sources, wherein the one or more light sources are light emitting diodes (LEDs).
[0302] In some embodiments, the one or more light devices further comprise one or more sensors configured to detect light energy from the array of one or more light sources.
[0303] In some embodiments, the one or more safety-critical components include computing hardware configured to execute one or more algorithms and configured to store information regarding the operation of the electronic device.
[0304] In some embodiments, the second controller is configured to turn one or more of the safety-critical components on or off based on one or more operating conditions of the device.
[0305] In some embodiments, the one or more safety components are collectively configured to implement a hardware watchdog.
[0306] In some embodiments, the one or more safety components are collectively configured to implement a software watchdog.
[0307] In some embodiments, the one or more non-safety critical components include a display configured to provide information to a user of the device and / or receive input from a user of the device.
[0308] In some embodiments, the present invention is used in a method for treating a biological fluid, the method including providing a biological fluid mixed with a pathogen inactivation compound, and irradiating the biological fluid with ultraviolet light having a first peak wavelength of about 315 nm to about 350 nm emitted by a set of one or more first light sources, wherein 1) each of the one or more first light sources emits light having a full width half maximum (FWHM) spectral bandwidth of less than 20 nanometers, or 2) each of the one or more first light sources is a light emitting diode (LED), and the irradiating the biological fluid occurs for a duration and intensity sufficient to inactivate pathogens in the biological fluid.
[0309] In some embodiments, the apparatus further includes a processing interface through which the first controller is communicatively coupled to the plurality of non-safety-critical components and the second controller is communicatively coupled to the plurality of safety-critical components; one or more processors; a memory; and one or more programs stored in the memory and configured to be executed by the one or more processors, wherein the one or more programs are configured to: communicatively couple the plurality of non-safety-critical components to the processing interface; and in response to communicatively coupling the plurality of safety-critical components to the processing interface, detect a presence of the plurality of non-safety-critical components and the plurality of safety-critical components at the controllers; send a first message between the first controller and the non-safety-critical components via the processing interface and send a second message between the second controller and the safety-critical components via the processing interface, the first message and the second message being based on a domain-specific interface language; determine a state of the non-safety-critical components based on the first message and determine a state of the safety-critical components based on the second message.
[0310] In some embodiments, the non-safety-critical component or the safety-critical component is in a first state, and the one or more programs further include instructions for changing the state of the non-safety-critical component or the safety-critical component from the first state to a second state, sending a second message from the non-safety-critical component or the safety-critical component via the processing interface to the first controller or the second controller in response to the change in state, receiving the second message at the first controller or the second controller, and determining a second state of the processing component in response to receiving the second message.
[0311] In some embodiments, the one or more programs further include instructions for supplying power to the electronic device, and in response to supplying power to the electronic device, the presence of a plurality of non-safety-critical components and a plurality of safety-critical components is further detected.
[0312] In some embodiments, the one or more programs further include instructions for assigning local network addresses and ports to the plurality of non-safety-critical components and the plurality of safety-critical components in response to supplying power to the electronic device, wherein the local network addresses or ports are based on a domain-specific interface language.
[0313] In some embodiments, one or more messages written in a domain-specific interface language may be sent using TCP / IP.
[0314] In some embodiments, a method of treating a biological fluid includes providing a biological fluid mixed with a photoactive pathogen inactivation compound, and irradiating the biological fluid with any of the devices described above for a duration and intensity sufficient to inactivate pathogens in the biological fluid.
[0315] In some embodiments, a method of operating an electronic device for processing a biological fluid, the electronic device including a controller, a non-safety-critical component, a safety-critical component, and a processing interface, the method including coupling the non-safety-critical component or the safety-critical component to the processing interface, detecting with the controller a presence of the non-safety-critical component or the safety-critical component in the electronic device in response to coupling of the non-safety-critical component or the safety-critical component to the processing interface, sending messages between the controller and the non-safety-critical component or the safety-critical component via the processing interface based on a domain-specific interface language, and determining a state of the non-safety-critical component or the safety-critical component based on the messages.
[0316] In some embodiments, the electronic device further comprises a second controller coupled to the processing interface, wherein the safety-critical component is coupled to the processing interface, and the method includes coupling the non-safety-critical component to the processing interface and isolating the non-safety-critical component from the safety-critical component, wherein the isolating includes configuring the domain-specific interface language to minimize an impact on the safety-critical component of one or more changes to the non-safety-critical component.
[0317] In some embodiments, the non-safety-critical component or the safety-critical component is in a first state, and the method further includes changing the state of the non-safety-critical component or the safety-critical component from the first state to a second state, sending a second message from the non-safety-critical component or the safety-critical component to the controller via the processing interface in response to changing the state, receiving the second message at the controller, and determining a second state of the processing component in response to receiving the second message.
[0318] In some embodiments, the safety-critical component is one of a platform, a modular light device, an agitator, and a safety component, and the one or more safety components are configured to monitor operation of the safety-critical component.
[0319] In some embodiments, the method further includes isolating the processing interface from external networks using a domain-specific interface language.
[0320] In some embodiments, the method further includes providing power to the electronic device, and the presence of the processing component is further detected in response to providing power to the electronic device.
[0321] In some embodiments, the method further includes assigning a local network address or port to the non-safety-critical component or the safety-critical component in response to supplying power to the electronic device, wherein the local network address or port is based on the domain-specific interface language.
[0322] In some embodiments, one or more messages written in a domain-specific interface language may be sent using TCP / IP.
[0323] In some embodiments, an electronic device for processing a biological fluid comprises a controller, a non-safety-critical component, a safety-critical component, a processing interface, one or more processors, memory, and one or more programs, the one or more programs stored in the memory and configured to be executed by the one or more processors, the one or more programs comprising instructions for: detecting, in response to coupling of the non-safety-critical component or the safety-critical component to the processing interface, using the controller to detect a presence of the non-safety-critical component or the safety-critical component in the electronic device; sending a message based on a domain-specific interface language via the processing interface between the controller and the non-safety-critical component to the processing interface; and determining a state of the non-safety-critical component or the safety-critical component based on the message.
[0324] In some embodiments, a non-transitory computer-readable storage medium storing one or more programs, the one or more programs comprising instructions that, when executed by an electronic device with one or more processors and a memory, cause the device to: couple a non-safety-critical component or a safety-critical component to a processing interface; in response to the coupling of the non-safety-critical component or the safety-critical component to the processing interface, detect, using a controller, the presence of the non-safety-critical component or the safety-critical component in the electronic device; send messages between the controller and the non-safety-critical component or the safety-critical component to the processing interface via the processing interface based on a domain-specific interface language; and determine a state of the non-safety-critical component or the safety-critical component based on the messages.
[0325] Variations of the embodiments provided herein may become apparent to those skilled in the art upon reading the foregoing description. It is anticipated that those skilled in the art will be able to employ such variations, as well as implementations of the compositions, methods, and kits described herein other than those specifically described herein, where appropriate. Accordingly, the systems and methods described herein include all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Furthermore, any combination of the above-described elements in all possible variations thereof is encompassed by the present description unless otherwise indicated herein or clearly contradicted by context. Below is a list of specific embodiments of the present disclosure. The list is illustrative and is not intended to limit the disclosure provided herein.
[0326] Embodiment 1: A modular light device for use in combination with an electronic device for treating a biological fluid, the modular light device comprising a plurality of components collectively configured to transmit light to one or more biological fluids for treatment, the modular light device comprising: a housing configured to house one or more components of the modular light device; A light source array chamber configured to transmit light, the light source array chamber comprising: one or more light source arrays including a plurality of light sources each configured to generate UV light; and the light source array chamber including one or more light sensors configured to detect light; a window portion configured to pass UV light generated by the plurality of light sources through the one or more biological fluids for treatment; a driver communicatively coupled to one or more components of the modular light device and configured to operate the one or more components.
[0327] Embodiment 2: The modular light device of embodiment 1, wherein the light source array chamber comprises one or more temperature sensors configured to measure temperature.
[0328] Embodiment 3: The modular optical device of embodiment 1 or embodiment 2, wherein each light source of the plurality of light sources emits light having a full width at half maximum (FWHM) spectral bandwidth of less than 20 nanometers.
[0329] Embodiment 4: The modular light device according to any one of embodiments 1 to 3, wherein each light source of the plurality of light sources is a light emitting diode (LED).
[0330] Embodiment 5: A modular light device described in any one of embodiments 1 to 4, wherein each of the one or more light source arrays comprises a respective first light source channel configured to emit ultraviolet light having a first peak wavelength of the array.
[0331] Embodiment 6: A modular optical device described in any one of embodiments 1 to 5, wherein the electronic device comprises a processing chamber configured to receive at least one of the one or more biological fluids.
[0332] Embodiment 7: A modular optical device described in any one of embodiments 1 to 6, wherein the modular optical device is configured to be placed within the electronic device to transmit light to one or more biological fluids within the processing chamber of the electronic device.
[0333] Embodiment 8: A modular light device described in any one of embodiments 1 to 7, wherein the housing comprises one or more tracks configured to mechanically interface with one or more rails of the electronic device so as to mechanically secure the modular light device when placed within the electronic device.
[0334] Embodiment 9: The modular light device of embodiment 8, wherein the one or more tracks are configured to allow slidable movement of the modular light device for removal and insertion into an electronic device.
[0335] Embodiment 10: A modular light device described in any one of embodiments 1 to 9, wherein the modular light device comprises one or more heat exchangers configured to dissipate heat from the light source array and / or the modular light device.
[0336] Embodiment 11: A modular light device as described in embodiment 10, wherein the one or more heat exchangers are configured to exchange heat with air passing through the one or more heat exchangers to transfer heat from the light source array and / or the modular light device.
[0337] Embodiment 12: A modular optical device described in any one of embodiments 10 to 11, wherein the one or more heat exchangers are configured to exchange heat with air passing through the one or more heat exchangers from one or more fans of the electronic device.
[0338] Embodiment 13: A modular light device according to any one of embodiments 1 to 12, wherein the window portion comprises a window material covering or surrounding an opening of the modular light device, the window material being made of glass.
[0339] Embodiment 14: A modular light device described in any one of embodiments 1 to 12, wherein the window portion comprises a window material covering or surrounding an opening of the modular light device, and the window material is made of a polymeric material.
[0340] Embodiment 15: The modular light device of any one of embodiments 1 to 14, wherein the window portion is at least 80% transparent to UV light of a selected wavelength.
[0341] Embodiment 16: A modular device described in any one of embodiments 1 to 15, wherein the modular light device comprises one or more light sensors arranged on the one or more light source arrays.
[0342] Embodiment 17: A modular light device described in any one of embodiments 1 to 16, wherein the modular light device comprises one or more light sensors disposed in the window portion and configured to detect light generated by the modular light device.
[0343] Embodiment 18: A modular light device described in any one of embodiments 1 to 17, wherein the modular light device comprises one or more circuits arranged in the window portion, and the one or more circuits comprise one or more light sensors arranged in the circuits and configured to detect light generated by the modular lighting device.
[0344] Embodiment 19: A modular lighting device described in any one of embodiments 1 to 18, wherein the light source array chamber includes a plurality of reflector panels arranged along one or more edges of the light source array chamber.
[0345] Embodiment 20: A modular light device as described in embodiment 19, wherein the plurality of reflector panels are positioned within the light source array chamber so as to minimize loss of light energy around the light source array chamber.
[0346] Embodiment 21: A modular light device described in any one of embodiments 1 to 20, wherein the one or more light sensors of the light source array chamber are oriented to detect light generated by a separate modular light device.
[0347] Embodiment 22: A modular light device described in any one of embodiments 1 to 21, wherein the one or more optical sensors are implemented using photodiodes.
[0348] Embodiment 23: A modular light device described in any one of embodiments 1 to 22, wherein the one or more temperature sensors are implemented using thermistors.
[0349] Embodiment 24: A modular light device described in any one of embodiments 1 to 23, wherein one or more of the one or more temperature sensors are configured to measure the temperature at a junction between one of the one or more light sources and a printed circuit board (PCB) on which the light source is disposed.
[0350] Embodiment 25: A modular light device described in any one of embodiments 1 to 24, wherein the multiple light sources are configured to generate UV-A light.
[0351] Embodiment 26: The modular light device of embodiment 25, wherein the plurality of light sources are configured to generate light having a first peak wavelength of about 315 nm to about 350 nm.
[0352] Embodiment 27: A modular light device described in any one of embodiments 1 to 24, wherein the multiple light sources are configured to generate UV-B or UV-C light.
[0353] Embodiment 28: A modular optical device described in any one of embodiments 5 to 27, wherein the array of one or more light sources each includes a respective second light source channel configured to emit ultraviolet light having a second peak wavelength of the array, the second peak wavelength differing from the first peak wavelength by at least 5 nanometers.
[0354] Embodiment 29: A modular light device as described in embodiment 28, wherein the array of one or more light sources each comprises a respective first light source channel configured to emit ultraviolet light having a first peak wavelength of the array in the UV-A spectrum, and a respective second light source channel configured to emit ultraviolet light having a second peak wavelength of the array in the UV-B or UV-C spectrum.
[0355] Embodiment 30: A modular light device described in any one of embodiments 1 to 29, wherein the housing comprises one or more electronic interfaces configured to communicatively couple the modular light device to the electronic device.
[0356] Embodiment 31: The modular light device described in embodiment 30, wherein the one or more electronic interfaces include an interlock connection configured to enable the electronic device to turn off the modular light device.
[0357] Embodiment 32: The modular light device of embodiment 30, wherein the one or more electronic interfaces comprise a communication port configured to enable the electronic device to send commands to the modular light device and to enable the modular light device to send data to the electronic device.
[0358] Embodiment 33: The modular light device described in embodiment 30, wherein the one or more electronic interfaces include a power port configured to transmit power from the electronic device to the modular light device.
[0359] Embodiment 34: A modular light device described in any one of embodiments 1 to 33, wherein some of the light sources of the light source array chamber are configured to provide a predetermined irradiance of light to the one or more biological fluids.
[0360] Embodiment 35: A modular light device described in any one of embodiments 1 to 34, wherein the one or more light sources of the light source array chamber collectively generate light such that the irradiance of the light is substantially uniform on the surface of the biological fluid.
[0361] Embodiment 36: A modular light device as described in embodiment 35, wherein the variation in irradiance of the light across the surface of the biological fluid is less than 25%.
[0362] Embodiment 37: A modular light device described in any one of embodiments 1 to 36, wherein the one or more light sources of the light source array chamber are LEDs configured to have a beam angle of approximately 110 degrees to approximately 130 degrees.
[0363] Embodiment 38: A modular light device described in any one of embodiments 1 to 37, wherein the dose irradiated to the biological fluid from the modular light device during the treatment process is based on light detected by one or more of the one or more light sensors.
[0364] Embodiment 39: A modular light device described in any one of embodiments 1 to 38, wherein the amount of time the modular light device is activated during a treatment process is based on light detected by one or more of the one or more light sensors.
[0365] Embodiment 40: A modular light device described in any one of embodiments 1 to 39, wherein the intensity of light generated by the modular light device during the treatment process is based on light detected by one or more of the one or more light sensors.
[0366] Embodiment 41: A modular optical device described in any one of embodiments 1 to 40, wherein the electronic device for processing a biological fluid comprises a first modular optical device oriented to face the biological fluid to be processed, and the first modular optical device irradiates light onto the biological sample for processing.
[0367] Embodiment 42: A modular light device described in any one of embodiments 1 to 41, wherein the electronic device for processing a biological fluid comprises a first modular light device and a second modular light device, the first and second modular light devices are oriented facing each other, and the first and second modular light devices collectively irradiate light onto the biological fluid for processing.
[0368] Embodiment 43: The first and second optical devices are configured to perform a test, the test comprising: transmitting light from the first modular light device; detecting the light transmitted from the first device by one or more light sensors of the second modular light device; and A modular light device as described in embodiment 42, comprising determining the presence or absence of one or more occlusions in the light transmitted by the first modular light device by comparing the detected light with a predetermined amount of light.
[0369] Embodiment 44: The test comprises: transmitting light from the second modular light device; detecting the light transmitted from the second modular light device by one or more light sensors of the first modular light device; and A modular light device as described in embodiment 43, further comprising determining the presence or absence of one or more occlusions in the light transmitted by the second modular light device by comparing the detected light with a predetermined light level.
[0370] Embodiment 45: A modular light device as described in embodiment 43 or 44, wherein the test further includes determining a baseline amount of light transmitted by the first modular light device to the second modular light device.
[0371] Embodiment 46: A modular optical device described in any one of embodiments 43 to 45, wherein the test is a test to determine the presence of an obstructed optical path within the electronic device.
[0372] Embodiment 47: A modular optical device described in any one of embodiments 43 to 45, wherein the test is a test to determine the presence of a biological fluid being processed within the electronic device.
[0373] Embodiment 48: The modular optical device is configured to perform a test, the test comprising: transmitting light from one or more light source arrays in the light source array chamber of the modular light device; A modular light device described in any one of embodiments 17 to 47, comprising detecting the light transmitted by the one or more light source arrays by one or more light sensors of the modular light device.
[0374] Embodiment 49: A modular light device as described in embodiment 48, wherein the one or more light sensors are light sensors disposed in the window portion of the modular light device.
[0375] Embodiment 50: A modular light device as described in embodiment 48 or embodiment 49, wherein the test further includes comparing the detected light with a predetermined amount of light.
[0376] Embodiment 51: The test comprises: a) determining the integrity of one or more of the one or more sensors; A modular lighting device described in any one of embodiments 48 to 50, including one or both of: a) determining the integrity of one or more light sources of the one or more light source arrays;
[0377] Embodiment 52: The modular light device is configured to perform a calibration process, the process comprising: transmitting light from one or more light source arrays of said modular light device; receiving data from a calibration device disposed within the electronic device, the calibration device configured to detect the light transmitted by the light source array(s) of the modular light device with one or more light sensors of the calibration device; comparing the received data with a predetermined amount of light; and A modular light device described in any one of embodiments 1 to 51, comprising adjusting the intensity of one or more light sources of the light source array(s) based on the comparison.
[0378] Embodiment 53: A method of treating a biological fluid, comprising: providing said biological fluid; and The method comprises irradiating the biological fluid with one or more modular light devices described in any one of embodiments 1 to 52 for a period and intensity sufficient to inactivate pathogens in the biological fluid.
[0379] Embodiment 54: A method of treating a biological fluid, comprising: providing said biological fluid in admixture with a pathogen inactivating compound; and The method comprises irradiating the biological fluid with one or more modular light devices described in any one of embodiments 1 to 52 for a period and intensity sufficient to inactivate pathogens in the biological fluid.
[0380] The foregoing description has been described with reference to specific embodiments for purposes of explanation. However, the illustrative discussion above is not intended to be exhaustive or to limit the disclosure to the precise form disclosed. Many modifications and variations are possible in light of the above teachings. The embodiments were chosen and described in order to best explain the principles of the techniques and their practical applications. This will enable those skilled in the art to optimally utilize the techniques and various embodiments, with various modifications suited to the particular use contemplated.
[0381] Although the disclosure and examples have been fully described with reference to the accompanying drawings, it should be noted that various changes and modifications will be apparent to those skilled in the art, and such changes and modifications are to be understood as being included within the scope of the disclosure and examples as defined by the claims.
Claims
[Claim 1] The invention described in this specification.
Citation Information
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