Modular optical device for biological fluid processing systems
The modular optical apparatus addresses the challenge of replacing light source components in biological fluid systems by providing a modular design with integrated sensors and drivers, ensuring efficient and cost-effective operation.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2021-10-18
- Publication Date
- 2026-03-25
AI Technical Summary
Existing systems for treating biological fluids with light face challenges in efficiently replacing and integrating light source components due to complex mechanical and electrical requirements, leading to inefficiencies and high costs when individual components fail.
A modular optical apparatus with a housing, light source array chamber, photosensors, and a driver/controller system that allows for easy replacement and integration of light sources, ensuring uniform light delivery and operational efficiency.
Enables cost-effective and efficient replacement of faulty light sources within biological fluid processing systems, maintaining uniform light distribution and operational integrity.
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Abstract
Description
[Technical Field]
[0001] Cross-reference of related applications This application claims priority to U.S. Provisional Application No. 63 / 093,722, filed on 19 October 2020, the entire contents of which are incorporated herein by reference.
[0002] This disclosure relates, in general, to systems, methods, and apparatus for treating biological fluids, including mixtures of biological fluids and photochemicals, with light, and more specifically, to modular optical apparatus architectures for use in biological fluid processing systems. [Background technology]
[0003] Systems and methods for treating biological fluids with light are well known. For example, U.S. Patent No. 7,459,695 (Patent Document 1), No. 6,986,867 (Patent Document 2), and No. 5,593,823 (Patent Document 3) describe systems for treating biological fluids with light to inactivate pathogens in the biological fluid. The light is emitted within a selected wavelength range that is effective in inactivating pathogens in the biological fluid, particularly by photochemical inactivation of the pathogens. Other systems and methods for treating biological fluids with light include, for example, U.S. Patent No. 6,843,961 (Patent Document 4), No. 7,829,867 (Patent Document 5), No. 9,320,817 (Patent Document 6), and No. 8,778,263 (Patent Document 7), WO2019133929A1 (Patent Document 8), and the systems and methods described in Schlenke, 2014, Transfus. Med. Hemother. 41:309-325.
[0004] For example, in the case of blood products containing platelets, plasma components, and their derivatives, it is important to ensure that the blood product is free of pathogens in order to minimize the risk of infection to the recipient. Tests for the presence of pathogens in the blood are limited by the available pathogens and the sensitivity of the assays. As an alternative or supplement to pathogen testing, methods for inactivating pathogens and reducing the risk of transfusion infection using inactivation methods based on various compounds (e.g., chemicals, photochemicals) are known in the art (e.g., as disclosed in Schlenke et al., Transfus Med Hemother, 2014, 41, 309-325 and Prowse, VoxSanguinis, 2013, 104, 183-199). A commercially available photochemical pathogen inactivation system based on psoralen and ultraviolet light for processing blood products is the INTERCEPT® Blood System (Cerus Corporation), which utilizes disposable processing sets and an ultraviolet 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. Multiple different disposable processing sets can be used depending on the type of blood product being processed and its specific characteristics, such as volume and platelet count.
[0005] To treat a biological fluid with light to inactivate pathogens in it, it is necessary to uniformly deliver a precise amount (e.g., dose) of the desired type of light (e.g., ultraviolet light) throughout the biological fluid. Therefore, in one or more examples, an electronic device configured to process a biological fluid may often include a dedicated light source component located inside the 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 important operating requirements for the electronic device, such as temperature, power consumption, and footprint. Therefore, the architecture and layout of the dedicated light source component are crucial to ensure that it can meet the requirements necessary to effectively inactivate pathogens in the biological fluid. For example, to ensure that UV light can effectively irreversibly crosslink the nucleic acids of pathogens and inactivate them, it may be necessary to irradiate the biological fluid with a specific amount of ultraviolet light (e.g., in combination with a pathogen inactivation compound) for a certain time and intensity. Therefore, the light source component must be designed to meet the requirements necessary for pathogen inactivation while simultaneously meeting other design requirements necessary to ensure that the entire electronic device is commercially viable.
[0006] Given the precise specifications to which the light source components must operate, and the need to replace them (likely multiple times during the lifespan of the processing unit), there is an unmet need to provide a modular design that allows for easy replacement of the optical device as needed, while simultaneously implementing the light source components to operate according to precise electrical and mechanical requirements. [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 [Overview of the project] [Means for solving the problem]
[0008] Designing light source components for electronic processing units to meet specific requirements can present numerous challenges. For example, the requirements imposed on a light source component may include not only the light source used to illuminate samples such as biological fluids, but also safety features necessary to ensure the safe operation of various sensors, electrical controls, and other light source components according to specifications. Over the lifespan of the electronic device, the performance of a light source component may degrade due to light source decay and / or burnout of the light source (e.g., light-emitting diodes (LEDs)), the average lifespan of the light source, or other unintended operating conditions that render the light source component inadequate for its intended purpose. However, while a light source component may not be operating according to its requirements, the rest of the electronic device may still function correctly. Therefore, simply replacing the entire electronic device is often cost-ineffective, and it is more practical to simply replace one or more faulty light source components instead. However, accessing a single light source component can be complex and result in an inefficient use of resources. Instead of replacing a single light source component, one alternative is to simply replace the entire optical device. However, if the optical device is integrated into an electronic device and removal is difficult or requires considerable time and resources, each time a component of the optical device fails, the device's customer or user may experience a significant delay in restoring the device to working order or expend considerable resources on repairs. Furthermore, replacing a light source component may require complex mechanical and electrical procedures to ensure that the replacement light source component works in conjunction with the other components of the device once installed. However, if replacing a light source component requires complex procedures, simply replacing the light source component may not be cost-effective if the component is faulty or otherwise unsuitable for use in the processing unit.
[0009] In some embodiments, the Disclosure provides a modular optical apparatus for use in combination with an electronic apparatus (e.g., an electronic processing apparatus) for processing biological fluids, wherein the modular optical apparatus comprises a plurality of components collectively configured to transmit light through one or more biological fluids for processing, the modular optical apparatus comprising a housing configured to house one or more components of the modular optical apparatus, and a light source array chamber configured to transmit light (e.g., ultraviolet (UV) at a selected wavelength (e.g., peak wavelength)), wherein the light source array chamber comprises one or more light source arrays, each comprising a plurality of light sources configured to generate UV light. The device comprises: one or more photosensors configured to detect (e.g., measure) light; a window portion (e.g., window opening, transparent window, translucent window) positioned on (i.e., on or in) a modular optical device configured to pass UV light generated by multiple light sources through one or more biological fluids for processing; a driver (e.g., a light source driver) communicatively coupled to one or more components of the modular optical device (e.g., a light source array chamber of the modular optical device) and configured to operate one or more components; and a controller communicatively coupled to the driver (e.g., a light source driver) and configured to operate the driver (e.g., a light source driver).
[0010] In some embodiments, the modular optical device light source array chamber includes one or more temperature sensors configured to measure the temperature (for example, of the optical device).
[0011] In some embodiments, each of the multiple light sources emits light having a full-width half-maximum (FWHM) spectral bandwidth of less than 20 nanometers.
[0012] In some embodiments, each of the multiple light sources is a light-emitting diode (LED).
[0013] In some embodiments, each of one or more light source arrays comprises a first light source channel configured to emit ultraviolet light having a first peak wavelength of the array.
[0014] In some embodiments, the electronic device includes a processing chamber configured to receive (e.g., hold, carry) at least one of one or more biological fluids (for processing).
[0015] In some embodiments, the modular optical device is configured to be placed within an electronic device in order to transmit light to one or more biological fluids within the 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 optical device when it is placed within the electronic device. In some embodiments, the housing includes one or more tracks configured to mechanically interface with one or more rails of the electronic device to mechanically secure the modular optical device when it is placed within the electronic device.
[0017] In some embodiments, one or more tracks are configured to allow the modular optical device to slide in order to remove the modular optical device and insert it into an electronic device.
[0018] In some embodiments, the modular optical device comprises one or more heat exchangers configured to dissipate heat from the light source array and / or the modular optical device.
[0019] In some embodiments, one or more heat exchangers are fin-shaped.
[0020] In some embodiments, one or more heat exchangers are configured to transfer heat from a light source array and / or modular optical device by exchanging heat with air passing through the one or more heat exchangers (e.g., being blown, moving).
[0021] In some embodiments, one or more heat exchangers are configured to exchange heat with air drawn across them by one or more fans located within an electronic device.
[0022] In some embodiments, the optical device includes one or more fans configured to pass air across one or more heat exchangers (e.g., blow, draw in, or move) in order to remove heat transferred by one or more heat exchangers.
[0023] In some embodiments, the window portion is an opening in the modular optical device (e.g., an opening within the housing of the modular optical device, or an opening to the light source array chamber of the modular optical device).
[0024] In some embodiments, the window portion includes window material that covers or surrounds an opening in the modular optical device (e.g., an opening in the housing of the modular optical device, an opening to the light source array chamber of the modular optical device).
[0025] In some embodiments, the window portion (e.g., window material) is made of glass.
[0026] In some embodiments, the window portion (e.g., window material) is made of a polymer material (e.g., 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 optical device includes one or more optical sensors positioned in a window section and configured to detect (e.g., measure) light generated by the modular optical device (e.g., by one or more light source arrays of the modular optical device, or by one or more light sources of the modular optical device).
[0030] In some embodiments, the modular optical device includes one or more circuits (e.g., flexible circuits) arranged in a window portion (e.g., on top of or across (at least partially)), and the one or more circuits (e.g., flexible circuits) includes one or more optical sensors arranged on the circuits (e.g., flexible circuits) and configured to detect (e.g., measure) light generated by the modular optical device (e.g., by one or more light source arrays of the modular optical device, by one or more light sources of the modular optical device).
[0031] In some embodiments, the light source array chamber includes a plurality of reflector panels arranged along one or more edges of the light source array chamber.
[0032] In some embodiments, multiple reflector panels are arranged within the light source array chamber to minimize the loss of light energy around the light source array chamber.
[0033] In some embodiments, one or more light sensors in a light source array chamber are oriented to detect (e.g., measure) light generated by a separate modular optical device (e.g., to detect (e.g., measure) light generated by another modular optical device located on the light source array).
[0034] In some embodiments, 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 temperature at the junction between the light source of one or more light sources and the printed circuit board (PCB) on which the light sources are arranged (a light source array).
[0037] In some embodiments, multiple light sources are configured to generate UV-A light.
[0038] In some embodiments, the multiple light sources are configured to produce light having a first peak wavelength in the range of approximately 315 nm to approximately 350 nm. In some embodiments, the multiple light sources are configured to produce light having a first peak wavelength in the range of approximately 315 nm to approximately 335 nm. In some embodiments, the multiple light sources are configured to produce light having a first peak wavelength in the range of approximately 320 nm to approximately 330 nm. In some embodiments, the multiple light sources are configured to produce light having a first peak wavelength in the range of approximately 330 nm to approximately 350 nm. In some embodiments, the multiple light sources are configured to produce light having a first peak wavelength in the range of approximately 345 nm ± 5 nm.
[0039] In some embodiments, multiple light sources are configured to generate UV-B or UV-C light.
[0040] In some embodiments, an array of one or more light sources each includes a second light source channel configured to emit ultraviolet light having a second peak wavelength of the array, the second peak wavelength being at least 5 nanometers different from the first peak wavelength.
[0041] In some embodiments, an array of one or more light sources each comprises a first light source channel configured to emit ultraviolet light having a first peak wavelength of the array in the UV-A spectrum, and a 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 includes one or more electronic interfaces configured to communicatively couple a modular optical device to an electronic device.
[0043] In some embodiments, one or more electronic interfaces include interlock connections configured to allow the electronic device to turn off the modular optical device.
[0044] In some embodiments, one or more electronic interfaces include a communication port configured to allow an electronic device to send commands to a modular optical device, and a communication port configured to allow the modular optical device to send data to the electronic device.
[0045] In some embodiments, one or more electronic interfaces include a power port configured to transmit power from an electronic device to a modular optical device.
[0046] In some embodiments, some light sources in a light source array chamber are configured to provide (e.g., transmit) a predetermined amount (e.g., density) of light to one or more biological fluids.
[0047] In some embodiments, one or more light sources in the light source array chamber collectively produce a substantially uniform dose (e.g., a certain amount) of light (e.g., on the surface of a biological fluid, on a plane within the volume of the biological fluid, within an irradiation dose, transmitted from a modular optical device). In some embodiments, one or more light sources in the light source array chamber collectively produce a substantially uniform irradiance (e.g., on or over the surface of a biological fluid (e.g., a container containing the biological fluid) within an irradiation dose, transmitted from a modular optical device). 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 in the light source array chamber emit light from any 5 cm onto the biological fluid (e.g., a container containing the biological fluid) 2 The area is collectively irradiated with a variation of less than 25% (overall average of the surface area) from the integrated irradiance of the entire surface barrier of the biological fluid (e.g., the container containing the biological fluid).
[0048] In some embodiments, one or more light sources in the light source array chamber are LEDs configured to have a beam angle (e.g., beam width) of about 110 to about 130 degrees. In some embodiments, one or more light sources in 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 onto the biological fluid from the modular optical device during the processing is based on (e.g., partially based, at least partially based) light detected (e.g., measured) by one or more optical sensors.
[0050] In some embodiments, the amount of time that a modular optical device is activated (e.g., emitting light) during a processing step is based on (e.g., partially based, at least partially based on) light detected (e.g., measured) by one or more optical sensors. In some embodiments, the amount of time that a modular optical device is activated is the amount of time that one or more light sources are activated (emitting light). In some embodiments, the amount of time that a modular optical device is activated is the amount of time that one or more light sources are activated in each cycle of pulse width modulation (e.g., pulse width modulation cycle). In some embodiments, the amount of time that a modular optical device is activated is the cumulative amount of time that one or more light sources are activated by pulse width modulation during a processing step.
[0051] In some embodiments, the intensity of light generated by the modular optical device during the processing process is based on (e.g., partially based, at least partially based on) light detected (e.g., measured) by one or more of the one or more photosensors. In some embodiments, the intensity of light generated by the modular optical device during the processing process may 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 photosensors).
[0052] In some embodiments, an electronic device for processing a biological fluid comprises a first modular optical device oriented (e.g., within the processing chamber of the electronic device) facing the biological fluid to be processed, the first modular optical device being oriented to transmit (or be configured to transmit) light to the biological fluid for processing (e.g., to deliver a certain amount or dose of light, or to deliver a predetermined or specified amount or dose of light). In some embodiments, an electronic device for processing a biological fluid comprises a first modular optical device and a second modular optical device (e.g., within the processing chamber of the electronic device), the first and second modular optical devices being oriented to face each other (e.g., each positioned toward the biological fluid to be processed), and the first and second modular optical devices collectively irradiate the biological fluid for processing. In some embodiments, the biological fluid contains (e.g., is mixed with) photochemical compounds (e.g., pathogen inactivating compounds).
[0053] In some embodiments, the first and second optical devices are configured to perform tests (e.g., operational tests, integrity tests, health tests) which include transmitting light from the first modular optical device, detecting (e.g., measuring) the light transmitted by the first device using one or more optical sensors of the second modular optical device, and determining whether one or more occlusions (e.g., interference, obstructions) are present in the light transmitted by the first modular optical device by comparing the detected light to a predetermined amount of light (e.g., comparing to a baseline amount of light, comparing to a predetermined level to determine a decrease in light (e.g., partial decrease, blockage)). In some embodiments, the test further includes determining a baseline amount of light transmitted by the first modular optical device (e.g., transmitted to the second modular optical device). In some embodiments, the test further includes calibrating the first modular optical device to set a baseline amount of light transmitted by the first modular optical device.
[0054] In some embodiments, the test further includes transmitting light from a second modular optical device, detecting (e.g., measuring) the light transmitted by the second modular optical device using one or more optical sensors of the first modular optical device, and determining whether one or more occlusions (e.g., interference, obstruction) are present in the light transmitted by the second modular optical device by comparing the detected light to a predetermined light level (e.g., comparing to a baseline light level, comparing to a predetermined level to determine a decrease in light (e.g., partial decrease, blockage)). In some embodiments, the test further includes determining a baseline amount of light transmitted by the second modular optical device (e.g., transmitted to the first modular optical device). In some embodiments, the test further includes calibrating the second modular optical device to set a baseline amount of light transmitted by the second modular optical device.
[0055] In some embodiments, the test is to determine the presence of an obstructed optical path within the electronic device (e.g., scratches or foreign matter (e.g., dust) on the window of a modular optical engine or on the platform / tray of the electronic device).
[0056] In some embodiments, the test is a test to determine the presence of a biological sample to be placed in an electronic device.
[0057] In some embodiments, the modular optical device is configured to perform tests (e.g., operational tests, integrity tests, soundness tests) which include transmitting light from one or more light source arrays in the light source array chamber of the modular optical device, detecting the light transmitted by one or more light source arrays by one or more optical sensors in the modular optical device (e.g., in the light source array chamber of the modular optical device), and comparing the detected light with a predetermined amount of light (e.g., to determine a decrease / change in light compared to a predetermined amount). In some embodiments, one or more optical sensors are optical sensors located in a window portion of the modular optical device (e.g., located in a circuit located in the window portion).
[0058] In some embodiments, the test further includes comparing the detected light with a predetermined light intensity.
[0059] In some embodiments, the test further includes determining the integrity (e.g., functional integrity, health status, operational status) of one or more sensors (e.g., each) (e.g., by comparing them to one another, by comparing them to a baseline or standard).
[0060] In some embodiments, the test further includes determining the integrity (e.g., functional integrity, health status, operating status) of one or more light sources (e.g., each) of one or more light source arrays (e.g., by comparing them to one another, by comparing them to a baseline or standard).
[0061] In some embodiments, the modular optical device is configured to perform a calibration process, which includes transmitting light from one or more light source arrays of the modular optical device, detecting the light transmitted by the light source array(s) of the modular optical device by one or more light sensors of an external calibration device (e.g., a radiometer), the calibration device being located within an electronic device, detecting, comparing the detected light with a predetermined amount of light, and adjusting one or more light sources of the light source array(s) (e.g., adjusting the intensity). In some embodiments, adjusting one or more light sources of the light source array(s) (e.g., adjusting the intensity) is done by adjusting the individual light sources. In some embodiments, adjusting one or more light sources of the light source array(s) (e.g., adjusting the intensity) is done by adjusting the light source channels. In some embodiments, adjusting one or more light sources of the light source array(s) (e.g., adjusting the intensity) is done by adjusting the light source array(s).
[0062] In another aspect of the present disclosure, a method for processing a biological fluid comprises providing the biological fluid and illuminating the biological fluid with one or more modular optical devices described in any one of the above embodiments for a period and intensity sufficient to inactivate pathogens in the biological fluid.
[0063] In some embodiments, a method for processing a biological fluid includes providing a biological fluid mixed with a pathogen inactivating compound, and illuminating the biological fluid with one or more modular light devices described in any one of the above embodiments for a period and intensity sufficient to inactivate pathogens in the biological fluid. The present invention provides, for example, the following: (Item 1) A modular optical device for use in combination with an electronic device for processing biological fluids, wherein the modular optical device comprises a plurality of components collectively configured to transmit light through one or more biological fluids for processing, and the modular optical device is A housing configured to accommodate one or more components of the modular optical device, A light source array chamber configured to transmit light, wherein the light source array chamber is One or more light source arrays, each including multiple light sources configured to generate UV light, The light source array chamber includes 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 one or more biological fluids for processing, The modular optical device comprises a driver that is communicatively coupled to one or more components of the modular optical device and configured to operate the one or more components. (Item 2) The modular optical apparatus according to item 1, wherein the light source array chamber comprises one or more temperature sensors configured to measure temperature. (Item 3) A modular optical apparatus according to item 1 or 2, wherein each 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) A modular optical device according to any one of items 1 to 3, wherein each of the multiple light sources is a light-emitting diode (LED). (Item 5) A modular optical apparatus according to any one of items 1 to 4, wherein each of the one or more light source arrays comprises a first light source channel configured to emit ultraviolet light having a first peak wavelength of the array. (Item 6) The modular optical apparatus according to 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) The modular optical device according to any one of items 1 to 6, wherein the modular optical device is configured to be placed within the electronic device in order to transmit light into one or more biological fluids within the processing chamber of the electronic device. (Item 8) A modular optical device according to 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 optical device when it is placed inside the electronic device. (Item 9) The modular optical device according to item 8, wherein one or more tracks are configured to allow the modular optical device to slide in order to remove the modular optical device and insert it into an electronic device. (Item 10) The modular optical device according to any one of items 1 to 9, wherein the modular optical device comprises one or more heat exchangers configured to dissipate heat from the light source array and / or the modular optical device. (Item 11) The modular optical device according to item 10, wherein 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 optical device. (Item 12) The modular optical device according to 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) The modular optical device according to any one of items 1 to 12, wherein the window portion comprises a window material that covers or surrounds the opening of the modular optical device, and the window material is made of glass. (Item 14) The modular optical device according to any one of items 1 to 12, wherein the window portion comprises a window material that covers or surrounds the opening of the modular optical device, and the window material is made of a polymer material. (Item 15) The modular optical device according to 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) The modular optical device according to any one of items 1 to 15, wherein the modular optical device comprises one or more optical sensors arranged on one or more light source arrays. (Item 17) The modular optical device according to any one of items 1 to 16, wherein the modular optical device comprises one or more optical sensors positioned in the window portion and configured to detect light generated by the modular optical device. (Item 18) The modular optical device according to any one of items 1 to 17, wherein the modular optical device comprises one or more circuits arranged in the window portion, and the one or more circuits comprises one or more light sensors arranged in the circuit and configured to detect light generated by the modular lighting device. (Item 19) The modular optical apparatus according to 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) The modular optical apparatus according to item 19, wherein the plurality of reflector panels are arranged within the light source array chamber to minimize the loss of light energy around the light source array chamber. (Item 21) The modular optical device according to any one of items 1 to 20, wherein one or more optical sensors in the light source array chamber are oriented to detect light generated by a separate modular optical device. (Item 22) A modular optical device according to any one of items 1 to 21, wherein one or more of the optical sensors are implemented using photodiodes. (Item 23) A modular optical device according to any one of items 1 to 22, wherein one or more temperature sensors are implemented using thermistors. (Item 24) A modular optical device as described in any one of items 1 to 23, wherein one or more of the one or more temperature sensors are configured to measure temperature at the junction between one of the one or more light sources and a printed circuit board (PCB) on which the light source is placed. (Item 25) A modular optical apparatus according to any one of items 1 to 24, wherein the plurality of light sources are configured to generate UV-A light. (Item 26) The modular optical apparatus according to item 25, wherein the plurality of light sources are configured to generate light having a first peak wavelength of approximately 315 nm to approximately 350 nm. (Item 27) A modular optical apparatus according to 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) The modular optical apparatus according to any one of items 5 to 27, wherein each of the arrays of one or more light sources includes a second light source channel configured to emit ultraviolet light having a second peak wavelength of the array, the second peak wavelength being at least 5 nanometers different from the first peak wavelength. (Item 29) The modular optical apparatus according to item 28, wherein each array of one or more light sources comprises a first light source channel configured to emit ultraviolet light having a first peak wavelength of the array in the UV-A spectrum, and a 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) The modular optical device according to any one of items 1 to 29, wherein the housing comprises one or more electronic interfaces configured to connect the modular optical device to the electronic device in a communicative manner. (Item 31) The modular optical device according to item 30, wherein the one or more electronic interfaces include an interlock connection configured to allow the electronic device to turn off the modular optical device. (Item 32) The modular optical device according to item 30, wherein the one or more electronic interfaces are communication ports, the communication ports being configured to allow the electronic device to send commands to the modular optical device and the modular optical device to send data to the electronic device. (Item 33) The modular optical device according to item 30, wherein the one or more electronic interfaces include a power port configured to transmit power from the electronic device to the modular optical device. (Item 34) A modular optical apparatus according to any one of items 1 to 33, wherein some of the light sources in the light source array chamber are configured to provide a predetermined amount of light to one or more biological fluids. (Item 35) A modular optical apparatus according to any one of items 1 to 34, wherein one or more light sources in 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. (Item 36) The modular optical device according to item 35, wherein the variation in the irradiance of the light across the surface of the biological fluid is less than 25%. (Item 37) The modular optical device according to any one of items 1 to 36, wherein one or more light sources in the light source array chamber are LEDs configured to have a beam angle of about 110 degrees to about 130 degrees. (Item 38) A modular optical device according to any one of items 1 to 37, wherein the dose irradiated onto a biological fluid from the modular optical device during the processing process is based on light detected by one or more of the one or more optical sensors. (Item 39) The modular optical device according to any one of items 1 to 38, wherein the amount of time the modular optical device is activated during the processing process is based on light detected by one or more of the one or more optical sensors. (Item 40) The modular optical device according to any one of items 1 to 39, wherein the intensity of light generated by the modular optical device during the processing process is based on light detected by one or more of the one or more optical sensors. (Item 41) The modular optical apparatus according to any one of items 1 to 40, wherein the electronic apparatus for processing a biological fluid comprises a first modular optical apparatus oriented to face the biological fluid to be processed, the first modular optical apparatus irradiates the biological sample with light for processing. (Item 42) A modular optical device according to any one of items 1 to 41, wherein the electronic device for processing a biological fluid comprises a first modular optical device and a second modular optical device, the first and second modular optical devices oriented to face each other, and the first and second modular optical devices collectively irradiate the biological fluid with light for processing. (Item 43) The first and second optical devices are configured to perform a test, and the test is: Transmitting light from the aforementioned first modular optical device, One or more optical sensors of the second modular optical device detect the light transmitted from the first device, and The modular optical device according to item 42, comprising determining the presence or absence of one or more occlusions to the light transmitted by the first modular optical device by comparing the detected light with a predetermined amount of light. (Item 44) The aforementioned test, Transmitting light from the aforementioned second modular optical device, One or more optical sensors of the first modular optical device detect the light transmitted from the second modular optical device, and The modular optical device according to item 43, further comprising determining the presence or absence of one or more occlusions to the light transmitted by the second modular optical device by comparing the detected light with a predetermined light level. (Item 45) The aforementioned test, A modular optical device according to item 43 or 44, further comprising determining the baseline amount of light transmitted to the second modular optical device by the first modular optical device. (Item 46) A modular optical device according to any one of items 43 to 45, wherein the test is for determining the presence of an obstructed optical path within the electronic device. (Item 47) A modular optical apparatus according to any one of items 43 to 45, wherein the test is for determining the presence of a biological fluid to be processed within the electronic device. (Item 48) The modular optical device is configured to perform tests, and the tests are, Transmitting light from one or more light source arrays in the light source array chamber of the modular optical device, The modular optical device according to any one of items 17 to 47, comprising detecting the light transmitted by the one or more light source arrays using one or more optical sensors of the modular optical device. (Item 49) The modular optical device according to item 48, wherein the one or more optical sensors are optical sensors arranged in the window portion of the modular optical device. (Item 50) The aforementioned test, A modular optical device according to item 48 or 49, further comprising comparing the detected light with a predetermined amount of light. (Item 51) The aforementioned test, a) Determining the integrity of one or more of the one or more sensors, b) Determining the integrity of one or more light sources of the one or more light source arrays, the modular optical apparatus according to any one of items 48 to 50. (Item 52) The modular optical device is configured to perform a calibration process, and the process is: Transmitting light from one or more light source arrays of the modular optical device, Receiving data from a calibration device located within the electronic device, wherein the calibration device is configured to detect the light transmitted by the light source array(s) of the modular optical device using one or more optical sensors of the calibration device. The received data is compared with a predetermined amount of light, and A modular optical device according to any one of items 1 to 51, comprising adjusting the intensity of one or more light sources of the light source array(s) based on the comparison described above. (Item 53) A method for processing biological fluids, To provide the aforementioned biological fluid, and The method comprising illuminating the biological fluid with one or more modular light devices described in any one of items 1 to 52 for a period and intensity sufficient to inactivate pathogens in the biological fluid. (Item 54) A method for processing biological fluids, To provide the biological fluid mixed with a pathogen inactivating compound, The method comprising irradiating the biological fluid with one or more modular optical devices described in any one of items 1 to 52 for a period and intensity sufficient to inactivate pathogens in the biological fluid. [Brief explanation of the drawing]
[0064] [Figure 1] This disclosure illustrates an exemplary apparatus for processing biological fluids according to embodiments of this disclosure. [Figure 2] Another illustrative diagram of the apparatus described with respect to Figure 1 for processing biological fluids according to embodiments of the present disclosure is shown. [Figure 3] Another illustrative figure for processing biological fluids according to embodiments of this disclosure is shown. [Figure 4] An exemplary process diagram of a system for processing biological fluids according to embodiments of this disclosure is shown. [Figure 5] This is a perspective view of an exemplary system for processing biological fluids according to embodiments of the present disclosure. [Figure 6] This is a perspective view of an exemplary system for processing biological fluids according to embodiments of the present disclosure. [Figure 7] A perspective view of an exemplary system for processing biological fluids according to embodiments of the present disclosure is shown. [Figure 8A] A perspective view of an exemplary system for processing biological fluids according to embodiments of the present disclosure is shown. [Figure 8B] A perspective view of an exemplary system for processing biological fluids according to embodiments of the present disclosure is shown. [Figure 9] This document shows an exemplary internal hardware layout of a system for processing biological fluids according to embodiments of the present disclosure. [Figure 10] This disclosure illustrates an exemplary modular optical device for use in a system for processing biological fluid systems according to embodiments of this disclosure. [Figure 11] This disclosure illustrates an exemplary modular optical device for use in a system for processing biological fluid systems according to embodiments of this disclosure. [Figure 12] A side view of an exemplary modular optical device for use in a system for processing biological fluid systems according to embodiments of the present disclosure is shown. [Figure 13] An exemplary modular optical device for use in a system for processing biological fluid systems according to embodiments of the present disclosure is shown in a bottom view. [Figure 14] This disclosure illustrates an exemplary thermal management structure for implementing a modular optical device for use in a system for processing biological fluid systems according to embodiments of this disclosure. [Figure 15A] Another diagram illustrating an exemplary internal hardware layout of a system for processing biological fluids according to embodiments of this disclosure is shown. [Figure 15B] Another diagram shows an exemplary modular optical device for use in a system for processing biological fluid systems according to embodiments of the present disclosure. [Figure 16] This disclosure illustrates a modular optical device test process according to an embodiment of this disclosure. [Figure 17A] An exemplary calibration process according to the embodiments of this disclosure is shown. [Figure 17B] Another exemplary calibration process according to the embodiments of this disclosure is shown. [Figure 18] An exemplary system diagram of a lighting system for processing biological fluids according to embodiments of the present disclosure is shown. [Figure 19] Another exemplary system diagram of a lighting system for processing biological fluids according to embodiments of the present disclosure is shown. [Figure 20]An exemplary system diagram of a system for processing biological fluids according to embodiments of this disclosure is shown. [Figure 21] This disclosure provides an exemplary implementation of a domain-specific communication protocol according to an embodiment of this disclosure. [Figure 22] This disclosure illustrates an exemplary method for operating an exemplary system for processing biological fluids according to embodiments of this disclosure. [Figure 23] Examples of computing devices according to embodiments of this disclosure are shown. [Modes for carrying out the invention]
[0065] The following description includes exemplary methods, parameters, etc. However, it should be noted that such descriptions are not intended to limit the scope of this disclosure, but rather are provided as descriptions of exemplary embodiments.
[0066] The following detailed description and embodiments of this disclosure refer to the accompanying drawings, which illustrate specific embodiments that can be implemented. It should be understood that other embodiments and examples can be implemented and modified without departing from the scope of this disclosure.
[0067] Furthermore, the singular forms “a,” “an,” and “the” used in the following descriptions are intended to include the plural form unless the context otherwise explicitly indicates otherwise. Where used herein, the term “and / or” should be understood to mean and encompass any and all possible combinations of one or more of the enumerated items relating to the subject. Where used herein, the terms “includes,” “including,” “comprises,” and / or “comprising” specify the presence of the described features, integers, steps, actions, elements, components, and / or units, but should be understood not to exclude the presence or addition of one or more other features, integers, steps, actions, elements, components, units, and / or groups thereof.
[0068] Some parts of the embodiments for carrying out the following inventions are presented relating to algorithms and symbolic representations of operations on data bits in computer memory. The descriptions and representations of these algorithms are means used by those skilled in the art to most effectively communicate the content of their work to others skilled in the art. Algorithms as used herein are generally considered to be a consistent sequence of steps (instructions) that lead to a desired result. These steps require the physical manipulation of physical quantities. Usually, though not essential, these quantities take the form of electrical, magnetic, or optical signals that can be stored, transferred, combined, compared, and otherwise manipulated. For reasons of general use, it is sometimes convenient to refer to these signals as “bits,” “values,” “elements,” “symbols,” “characters,” “terms,” “numbers,” etc. Furthermore, without loss of generality, it is sometimes convenient to refer to specific arrangements of steps requiring the physical manipulation of physical quantities as modules or code devices.
[0069] However, these or similar terms are merely convenient labels associated with appropriate physical quantities and applied to those quantities. Unless otherwise noted, and as will be evident from the following discussion, discussions throughout this explanation using terms such as “process,” “calculate,” “compute,” “determine,” and “display” refer to the operation and processes of a computer system or similar electronic computing device that manipulates and transforms data represented as physical (electronic) quantities in the memory or registers of a computer system, or other information storage, transmission, or display device.
[0070] Certain aspects of the present invention may include process steps and instructions described herein in the form of algorithms. It should be noted that the process steps and instructions of the present invention can be embodied in software, firmware, or hardware, and if embodied in software, they can be downloaded, reside on different platforms used by various operating systems, and operated from there.
[0071] Figure 1 shows an exemplary system 100 for processing biological fluids. As used herein, “biological fluid” means any fluid containing one or more components (e.g., bioagents) found in or derived from living organisms (e.g., humans, animals, plants, microorganisms), or found in, isolated from, or derived from living organisms (including synthetic (e.g., mutant) versions thereof). Biological fluids may 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., treatment agents, antibodies), bacterial cultures, viral suspensions, etc. As used herein, “blood product” means blood (e.g., whole blood), or components or origins of blood, for example, erythrocytes, leukocytes, platelets, plasma, or components thereof (e.g., coagulation factors, albumin, fibrinogen), cryoprecipitates and decryoplasma (e.g., cryo-reduced) plasma, or one or more combinations of such components separated from blood. In one or more embodiments, the biological fluid may further include non-biological fluids, such as physiological solutions (e.g., dilutions), including, but not limited to, physiological saline, buffer solutions, nutrient solutions, platelet additive solutions (PAS), and / or anticoagulant solutions. In one or more embodiments, when the biological fluid is placed in a chamber (not shown) of a biological fluid processing system (e.g., in a container such as a processing bag placed or held on a platform), the biological fluid is irradiated with light having a particular spectral profile (e.g., visible light, ultraviolet light) 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. While System 100 in Figure 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 disclosure. In some embodiments, System 100 can 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 supplied to the system 100 in response to input to a power switch 110. For example, the power switch 110 may be a mechanical button. When the system 100 is off, power is supplied to the system 100 in response to a press of the power switch 110 (e.g., the system 100 turns on). When the system 100 is on, the power supplied to the system 100 is cut off in response to a press of the power switch 110 (e.g., the system 100 turns off). In some examples, the system 100 remains on during processing and does not turn off in response to a press of the power switch.
[0074] As another example, the power switch 110 may be a capacitive switch that can be activated by touch input (for example, by placing the user's finger on the power switch). As yet another example, the power switch may be a button having two or more states. When the power switch is in a first position (for example, not pressed, flipped to the first side), the power switch may be in an "off" state. When the power switch is in a second position (for example, not pressed, flipped to the second side), the power switch may be in an "on" state.
[0075] In some embodiments, the display 120 is a touchscreen. For example, the display 120 can be a capacitive touchscreen or a resistive touchscreen. In some embodiments, the display 120 is configured to display a graphical user interface (GUI) for operating the system 100. In some embodiments, the display 120 is configured to receive input from the scanner 130. In one or more embodiments, the display 120 is configured to receive input on the GUI. For example, one of several GUI objects displayed on the GUI may be selected by providing manual user input (e.g., touch input or hover input) on the touchscreen. In response to receiving input, the system 100 can perform an operation associated with the selected GUI object. For example, the GUI object may be associated with initiating biological fluid processing, and in response to receiving input to select the GUI object, the system 100 starts the process of processing the biological fluid. In one or more embodiments, the display 120 is configured to display instructions to the user operator (e.g., operator instructions) on the GUI. In some embodiments, the display 120 is configured to display input from the scanner 130 to the user operator. In some embodiments, the display 120 is configured to display input from sound (e.g., speech-to-text conversion) which is detected by voice input (e.g., one or more microphones) and processed by one or more processors into a visual form (e.g., command text, command code) on the display 120 that can be recognized by the user as input commands, such as user voice commands which are detected by one or more microphones (e.g., located in any configuration of the internal, external, and / or part of the external housing of system 100) and converted by one or more processors into command text on the display 120 that can be recognized by the user as input commands.In some embodiments, the display 120 is configured to display input from user visual motion, which is detected by motion sensors (e.g., one or more cameras) and processed by one or more processors into visual form on the display 120 (e.g., command text, command code, command icon, command graphic) that can be recognized by the user as input commands (e.g., motion-to-text conversion, motion-to-graphic conversion), such as a user's hand gesture (e.g., a swiping hand movement), which is detected by one or more cameras (e.g., located in any configuration of the internal, external, and / or part of the external housing of the system 100) and converted by one or more processors into visual command text or visual graphics on the display 120 that can be recognized by the user as input commands. Although one display 120 is shown in Figure 1, the system 100 may include multiple displays in some embodiments.
[0076] The user interface of system 100 can be simplified by using a touchscreen as an input component and / or input from scanner 130. For example, using a touchscreen reduces the need for physical buttons to correspond to functions that can be performed similarly using the touchscreen. Biological fluid processing using system 100 can be made more efficient with the simplified user interface.
[0077] While the power switch 110 and the display 120 are described as elements of the system 100 that can be configured to receive user input, other elements or input means can be included in the system 100 without departing from the scope of this disclosure. For example, the system 100 may include directional input keys, a mousepad, or a scroll wheel configured to operate a GUI displayed on the display 120. In some embodiments, the system 100 is configured to receive user input from sound, which is detected by voice input (e.g., one or more microphones) and processed by one or more processors into a linguistic form (e.g., command text, command code) that the system 100 can recognize as input commands (e.g., speech-to-text conversion), such as user voice commands, which are detected by one or more microphones (e.g., located in any configuration of the internal, external, and / or part of the external housing of the system 100) and converted by one or more processors into command text that the system 100 can recognize as input commands. In some embodiments, System 100 is configured to receive input from the user's visual-motor movements, which are detected by motion sensors (e.g., one or more microphones) and processed into linguistic form (e.g., command text, command code) by one or more processors (e.g., speech-to-text conversion), such as the user's hand gestures, which are detected by one or more microphones (e.g., located in any configuration of the internal, external, 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 input commands. Alternatively or additionally, System 100 may be configured to receive input other than user input, such as from one or more sensors implemented for System 100.Non-limiting examples of various sensors that may be implemented (for example, within the processing chamber together with the light source component) include one or more optical sensors configured to measure the light intensity in various parts of the processing chamber and / or the light intensity incident on various parts of 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 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, retroreflective sensors, light transmission sensors, label readers, scanners, barcode scanners, RFID sensors, etc.); one or more sensors for detecting the properties of the biological fluids (e.g., transmittance) (e.g., optical sensors, spectroscopic sensors); one or more sensors for detecting photochemical compounds in the biological fluids (e.g., fluorescence spectroscopy); and one or more sensors (e.g., ultrasonic sensors) arranged to detect the fluid depth of a portion (e.g., various parts) of 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 may be 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 compatibility bag, a processing bag) (not shown), and that container or other containers in a double container assembly (e.g., a disposable fluid processing set) may include tags or labels or designated areas containing some form of identification information, such as a visible form (e.g., a barcode, a QR code®, etc.) and / or a transmittable form (e.g., an electronic identifier, radio frequency identification (RFID)). In some embodiments, the identification information may represent information about the biological fluid, such as biological parameters or other parameters (e.g., a supply ID, a product code, a set code, a lot number, a type of biological fluid, a volume of the biological fluid, the contents of the biological fluid, e.g., platelet count), and processing parameters. In some embodiments, biological parameters or other parameters may optionally be combined with inputs from one or more sensors and / or user inputs to determine the processing parameters. In some cases, multiple sets of identification information can be obtained. For example, multiple sets of identification information may be located on one or more containers associated with the biological fluid (e.g., containers that store the biological fluid or are part of a double container assembly that stores it), and the sets of identification information can be obtained from each container by the scanner 130.In some embodiments, the scanner may be a multiscan scanner (e.g., a camera with multiscan functionality, a camera in conjunction with a circuit having multiscan processing functionality (e.g., hardware and / or software), a handheld scanner with multiscan functionality, a handheld scanner in conjunction with a circuit having multiscan processing functionality (e.g., hardware and / or software), a label reader with multiscan functionality, a label reader in conjunction with a circuit having multiscan processing functionality (e.g., hardware and / or software), which sequentially or substantially simultaneously scan multiple sets of identification information (e.g., multiple barcodes, multiple QR codes®, multiple labels, optical character recognition (OCR), image recognition, etc.) placed in one or more containers, with different strings or configurations of alphanumeric text and / or symbols. The system is configured to capture (e.g., acquire), for example, to capture multiple sets of identifying information in "batch" mode (for example, in response to a single user input or a single device input that commands, triggers, or otherwise initiates a multiscan operation to acquire multiple sets of identifying information). A single multiscan operation can capture multiple sets of identifying information sequentially or substantially simultaneously (e.g., simultaneously) (for example, in a single operation, the camera can capture one or more images of one or more labels indicating multiple parameters of a biological product, for example, offering 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 multiscanner can perform one or more scans of one or more of the labels indicating the above multiple parameters).In some embodiments, the multiscanner or system 100 is configured to recognize (and / or convert to another format recognizable by the multiscanner or system 100) multiple sets of captured identification information (e.g., barcodes, QR codes®, alphanumeric text and / or symbols, images) captured in a multiscan operation. After capturing multiple sets of identification information (e.g., in captured images, in performed scans), the multiscanner can transmit or communicate them to system 100 (e.g., via a wired or wireless connection) in a recognized (and / or converted) format (e.g., a linguistic format that system 100 can already recognize, for example, as parameter data) or in an unrecognized format (e.g., in captured images, in performed scans). If in an unrecognized format, system 100 can process the multiple sets of captured identification information into a recognizable format. When system 100 displays the GUI of the processing chamber associated with the biological fluid being processed, it can assign multiple sets of identification information to the corresponding fields (e.g., auto-entered information fields) of the GUI on display 120. Therefore, multi-scan operations can provide data entry to multiple specific data fields for all or most of the parameter data of the biological fluid through convenient, efficient, and time-saving auto-entering techniques. For example, in a multi-scan operation, the user does not need to perform multiple scans in a specific order to capture multiple sets of identification information that may be presented in a specific order (e.g., they do not need to perform a scan for each label on the container in the visual order of the specific data fields presented to the user on the GUI).
[0079] In some embodiments, identification information can be within the field of view of scanner 130, and scanner 130 can acquire the identification information when the information is within its field of view. For example, a user can hold a biological fluid processing container (e.g., a bag) with a barcode facing scanner 130, and scanner 130 can image, scan, or read the barcode, and based on the obtained barcode, system 100 can determine information about the biological fluid product. In some embodiments, identification information can be within the detection range of scanner 130, and scanner 130 can acquire the identification information when the information is within its detection range. For example, a user can hold a biological fluid processing bag with an RFID tag near scanner 130, and scanner 130 can detect the RFID tag, and based on the information obtained from the detected RFID tag, system 100 can determine information about the biological fluid product.
[0080] Although the scanner 130 is shown as being located outside the system 100 in Figure 1, the scanner 130 can be located in different locations within the system 100. In one or more embodiments, the scanner 130 is located inside the system 100. For example, the scanner 130 can be located above the processing chamber of the system 100. The scanner 130 can acquire information related to the biological fluid after the biological fluid has been placed on the platform and / or inside the chamber.
[0081] In some examples, the scanner 130 may be included in a device coupled to the system 100. For example, the scanner 130 may be included in a handheld scanner (e.g., a barcode scanner, a QR code® scanner) coupled to the system 100. In some embodiments, the scanner 130 is coupled to the system 100 via a wired connection. In some embodiments, the scanner 130 is coupled to the system 100 via a wireless connection.
[0082] Although one scanner 130 is shown in Figure 1, system 100 may include multiple scanners 130. For example, system 100 may include multiple processing chambers, each of which may have a corresponding scanner (e.g., an internal scanner). In another example, system 100 may include multiple platforms, each of which may have a corresponding scanner (e.g., an external scanner) positioned near or in the opening of the respective platform. As the platforms move through the opening, a container holding a biological fluid (e.g., a processing bag) may pass through the field of view of each scanner, and information associated with the biological fluid may be acquired by each scanner in a visible form on the container or the container of the associated double-container assembly. In yet another example, system 100 may include both a first scanner integrated with the system (e.g., located outside system 100 and located inside the processing chamber of system 100) and a second scanner coupled to system 100 (e.g., a handheld scanner).
[0083] In some embodiments, the platform 140 (e.g., a drawer, tray, well, plate, or stage) is configured to hold a biological fluid during processing (e.g., in a container for storing the biological fluid). In some embodiments, the platform is movable between the inside and outside of the processing chamber (e.g., slidably movable and configured to translate from the inside of the processing chamber to the outside of the processing chamber (e.g., partially outside the processing chamber)). In some embodiments, the platform further comprises a first panel 180 movable between a closed position and an open position, the first panel 180 covering a first opening to a first processing chamber in the closed position, and the first panel 180 not covering 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 together with the platform 140 (e.g., in a drawer configuration). In some embodiments, the first panel 180 is a separate structure from the platform 140 (for example, a separate hinged door that covers or does not cover the first opening to the first processing chamber), and the platform 140 can slide in and out of the first processing chamber independently of the first panel 180.
[0084] In some embodiments, the platform and / or the first panel can be locked to remain in a closed position during processing. By locking the first panel to remain in the closed position, system 100 can prevent the user from prematurely accessing the contents of the platform 140 during processing (e.g., accessing the processing chamber). In some embodiments, the first panel can be locked by pins (e.g., solenoids and pins) or a magnetic locking mechanism. System 100 can allow the user to access the contents of the platform 140 before and after processing (e.g., placing biological fluids on the platform 140, removing biological fluids from the platform 140) or after input (e.g., input on a GUI, input to open a latch, input to a button switch) by unlocking the first panel.
[0085] As shown in Figure 1, the structure of platform 150 symmetrically reflects the structure of platform 140 around the 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 arranged horizontally 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, since the first panel 180 may be associated with platform 140, the second panel 190 may be associated with platform 150.
[0086] Although two platforms are shown as part of system 100 in Figure 1, system 100 may include one or more platforms substantially similar to platform 140 or platform 150 without departing from the scope of the disclosure. Generally, the illustrated number of platforms and processing chambers associated with systems 100-300 is 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 disclosure. For example, in one or more embodiments, the system may include only one chamber with only one platform. In one or more embodiments, the system may include only one chamber with two or more platforms. In some embodiments, the system may include two chambers, each having only one platform. In some embodiments, the system may include two chambers, each having 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 for storing a biological fluid (e.g., a container of a double-container assembly) in a position for irradiation. In some embodiments, the second compartment is configured to hold a container that does not store a biological fluid (e.g., a container of a double-container assembly) in a position not for irradiation. In some embodiments, the platform is configured to separately retain a first container containing at least a first biological fluid and a second container containing a second biological fluid. In some examples, the platform is transparent to light with 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., made of a material selected to transmit light of selected wavelengths, and being substantially transparent, >95% transparent, >90% transparent, >80% transparent, >80% transparent, >70% transparent, >60% transparent, >50% transparent). In some embodiments, the platform is transparent to ultraviolet light (e.g., UV-A, UV-B, and / or UV-C) (e.g., substantially transparent, >95% transparent, >90% transparent, >80% transparent, >80% transparent, >70% transparent, >60% transparent, >50% transparent).
[0088] Figure 2 shows an exemplary system 200 for processing biological fluids. 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, the system 200 includes an external scanner 230. As shown, the external scanner 230 is located outside a housing that accommodates the other elements and can be operably coupled to the processor of the system 200. In some embodiments, the external scanner 230 is a handheld scanner. Although the external scanner 230 is shown with a wireless connection in Figure 2, the external scanner 230 can be operably coupled using a wired connection.
[0090] As shown in Figure 2, platforms 240 and 250 are in a retractable configuration in the open position, in contrast to platforms 140 and 150, which are in the closed position in Figure 1. Although both platforms 240 and 250 are shown open in the retractable configuration in Figure 2, it is also possible for one platform in the retractable configuration to be opened at a time (for example, while the other remains closed).
[0091] In some embodiments, the first panel 280 and the second panel 290 associated with platforms 240 and 250 lack any handles. In some embodiments, in the closed position, the panel can be opened by applying a force opposite to the opening direction (e.g., by pushing the outside of the panel to engage a push latch that releases the panel to open it). In some embodiments, in the closed position, the panel 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 a platform in a drawer configuration). In some embodiments, the system allows the user to access the contents of the platform by opening the panel (e.g., by a spring mechanism) and then manually slide the user out of the platform. For example, according to a decision that a processing procedure has started or is complete, the system can mechanically open one or more panels corresponding to processing for loading or unloading one or more biological fluid containers (e.g., processing bags).
[0092] In some embodiments, the platform includes compartments 260 substantially similar to those described herein. Figure 2 shows the platform with one compartment visible (for example, a platform with a drawer configuration in the open position), but each platform of the system 200 may include any number of compartments without departing from the scope of application.
[0093] Figure 3 shows 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 arranged vertically. 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, where platforms 140 and 150 are arranged horizontally, platforms 340 and 350 are arranged vertically such that the first and second biological fluids are on parallel planes when placed on the first and second platforms, respectively. Also, in contrast to system 300, where panels 180 and 190 are arranged horizontally, panels 380 and 390 are arranged vertically.
[0094] The embodiments in Figures 1-3 are intended to provide an illustrative context for the system architecture described in detail below, and are not intended to limit the scope to that architecture. The system architecture presented herein can be used in various biological fluid processing devices not mentioned above with respect to Figures 1-3.
[0095] Figure 4 shows an exemplary process diagram of a system for processing biological fluids according to embodiments of the present disclosure. Diagram 400 in Figure 4 shows various components of the system for processing biological fluids and presents a mapping of the functions each component performs with respect to the processing process. In embodiments of Figure 4, the diagram may include a plurality of processes 402, 404, 406, 408, and 410 that can interact with each other collectively for processing biological fluids. In one or more embodiments, the apparatus and system for processing biological fluid samples may include a photosensing 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 photosensing process 402 may utilize (e.g., interact with) one or more photosensors (e.g., photodiodes) 412. The photosensors 412 may be configured to convert light into electric current. In one or more embodiments, the electric current radiated from the photosensors 412 may be proportional to the amount of light received by the photosensors. The photosensing process 402 may also interact with one or more light sources (e.g., UV light sources) 414. In one embodiment, the photosensing process 402 may include using one or more photosensors 412 to sense light generated by one or more light sources (e.g., UV light sources) 414. In one or more embodiments, the current generated by the photosensors 412 based on the light generated by the light sources (e.g., UV light sources) 414 is transmitted to a controller 416 so that the controller 416 can ensure that the biological fluid being processed receives an appropriate amount of light necessary for processing the biological fluid.
[0096] In one or more embodiments, the apparatus and system for processing a biological fluid may include an illumination process 404 configured to generate light (e.g., UV light) applied to a particular biological fluid. The illumination process 404 may include causing one or more light sources (e.g., UV light sources) 414 to generate light (e.g., UV light) (as described above) for processing the biological fluid. As shown in Figure 400, the illumination process 404 can act on both the biological fluid in the biological fluid (e.g., in a mixture thereof), for example, blood components (e.g., platelets / plasma) 428, and a photoactive pathogen inactivating compound 430, such as psoralen (e.g., amotosalen).
[0097] In one or more embodiments, the apparatus may include a stirring process 406. The stirrer 406 may be configured to agitate the contents of the processing vessel (e.g., during the processing of a biological fluid by photocatalysis) to distribute (e.g., evenly distribute) the biological fluid and / or pathogen inactivating compounds into the biological fluid (e.g., by mixing). The agitation can facilitate the processing, for example, by providing a mixture of compounds (e.g., photochemical compounds, pathogen inactivating compounds) in the biological fluid, or by maintaining the components of the biological fluid (e.g., platelets, cells) in a suspended state. In one or more embodiments, the stirring process 406 may include causing a mechanical stirrer 418 to agitate the biological fluid (e.g., a biological fluid containing a photoactive pathogen inactivating compound 430). In one or more embodiments, a controller 416 may control the stirrer 418 to perform the stirring process 406. In one or more embodiments, one or more motors or servos (e.g., mounted on or on the platform) may be configured as the mechanical stirrer 418. One or more motors or servos may be physically coupled to the platform or a portion thereof and may move the platform or a portion thereof (e.g., associated trays) back and forth (e.g., along rails or tracks) to agitate the biological fluid held on the platform (e.g., a biological fluid in a container). One or more motors or servos may be part of any suitable agitation design (e.g., a lead screw design in which one or more motors or servos move a lead screw attached to the platform or a portion thereof, a belt drive design in which one or more motors or servos engage with one or more tracks attached to the platform or a portion thereof and move one or more belts that rotate one or more gears (e.g., toothed gears) that move the tracks) and may operate based on control signals from electrical wiring electrically connected to the control circuit.In one or more embodiments, the system may be configured to control (e.g., controllably) one or more aspects of the stirring motion, such as offset (i.e., stroke length of reciprocating (linear, longitudinal, etc.) motion during stirring), speed, acceleration, and deceleration. In some embodiments, the stirring speed may be adjustable (e.g., adjustable to have different speeds between different processes, adjustable to have different speeds during a single process, adjustable based on a predetermined speed plan, and dynamically adjusted in real time based on real-time user input). Such a control circuit may control the stirrer (e.g., one or more motors or servos) based on a control program implemented as software and / or hardware of the control circuit.
[0098] In one or more embodiments, the apparatus may include a transfer process 408. In one or more embodiments, the transfer process 408 may include operations necessary to transfer biological fluids into and out of the processing chamber. For example, the transfer process 408 may include operating one or more doors of the illumination chamber 420 to open and close, lock or unlock, depending on the part of the processing process in which the apparatus is currently involved. In one or more embodiments, a controller 416 may control the illumination chamber 420 to perform the transfer process 408.
[0099] In one or more embodiments, the apparatus may include a temperature control process 410. In one or more embodiments, the temperature process 410 may include the operation of one or more hardware components (e.g., airflow and / or temperature sensors 422, a heat exchanger 424, fans 426) collectively configured to maintain the apparatus (e.g., a biological fluid being handled) within a specific temperature range. In one or more embodiments, the temperature control process 410 may be configured to operate one or more fans 426 that can act on the outside air 432 (e.g., in conjunction with the heat exchanger 424) to cool the apparatus when the internal temperature of the apparatus exceeds a predetermined temperature threshold (e.g., detected by a temperature sensor (e.g., a thermistor) 422). In one or more embodiments, a controller 416 may control one or more fans 426 to perform the temperature control process 410.
[0100] Figure 5 is a perspective view of an exemplary system 500 for processing biological fluids. In some embodiments, system 500 is substantially similar to system 100, as shown in Figure 1. The exemplary system 500 for processing biological fluids 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 one or more biological fluids 510. In some embodiments, the light source array 506 may comprise a single light source within the chambers 502 and 504 arranged to irradiate one or more biological fluids 510. In other embodiments described below with respect to Figure 6, multiple light source arrays can be used to illuminate one or more biological fluids arranged in various embodiments of the chambers 502 and 504. As described herein, “light source array” means one or more light sources arranged on any two-dimensional or three-dimensional surface (e.g., continuous surface, discontinuous surface).
[0101] One or more light source channels may be included in the array of light sources of this 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 wavelength (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 multiple light sources may have different peak wavelengths as 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 different peak wavelengths. In a light source channel having multiple light sources, each light source may have its own peak wavelength (e.g., maximum peak wavelength), all of which are within the wavelength range of the light source channel (e.g., in the ranges of 1 to 20 nm, 1 to 10 nm, e.g., above and / or below a particular wavelength of 1 nm, 2 nm, 3 nm, 4 nm, 5 nm, or more). For example, in some embodiments, in a light source channel having multiple light sources, all light sources may have peak wavelengths within the range described in this disclosure, e.g., for example, 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). In a light source channel, each light source may be any light source that provides light with desired characteristics (e.g., peak wavelength, maximum peak wavelength, spectral bandwidth), including, but not limited to, solid-state irradiation (SSL), light-emitting diodes (LEDs), organic light-emitting diodes (OLEDs), polymer light-emitting diodes (PLEDs), and laser diodes. The light source channels of a light source array can be connected in series, parallel, or a combination of series and parallel circuits. In a light source channel with multiple light sources, those light sources can be controlled together or separately.
[0102] Each light source channel can be tuned or configured to emit light at different intensities (e.g., adjusting the amount of light, adjusting the amount of energy) so that light of one or more peak wavelengths is applied to one or more parts of the biological fluid. For example, each light source channel can emit light at maximum intensity (e.g., 100%) or below 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 various types 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 with various peak wavelengths. For example, the emitted peak wavelength(s) may be ultraviolet A spectrum (e.g., 315-400 nm), ultraviolet B spectrum (e.g., 280-315 nm), ultraviolet C spectrum (e.g., 100-280 nm, 200-280 nm, 240-280 nm), or visible light spectrum (e.g., 400-800 nm). In some embodiments, the emitted peak wavelength(s) may be approximately 240 nm to 250 nm, approximately 245 nm to 255 nm, approximately 250 nm to 260 nm, approximately 255 nm to 265 nm, approximately 260 nm to 270 nm, approximately 265 nm to 275 nm, approximately 270 nm to 280 nm, or approximately 275 nm to 285 nm. In some embodiments, the emitted peak wavelength(s) may be approximately 280 nm to 290 nm, approximately 285 nm to 295 nm, approximately 290 nm to 300 nm, approximately 300 nm to 310 nm, approximately 305 nm to 315 nm, or approximately 310 nm to 320 nm. In some embodiments, the emitted peak wavelength(s) may be approximately 315nm to 325nm, 320nm to 330nm, 325nm to 335nm, 330nm to 340nm, 335nm to 345nm, 340nm to 350nm, 345nm to 355nm, 350nm to 360nm, 355nm to 365nm, 360nm to 370nm, 365nm to 375nm, 370nm to 380nm, 375nm to 385nm, 380nm to 390nm, 385nm to 395nm, or 390nm to 400nm.In some embodiments, the emitted peak wavelength may be approximately 240 nm, approximately 245 nm, approximately 250 nm, approximately 255 nm, approximately 260 nm, approximately 265 nm, approximately 270 nm, approximately 275 nm, approximately 280 nm, approximately 285 nm, approximately 290 nm, approximately 295 nm, approximately 300 nm, approximately 305 nm, approximately 310 nm, approximately 315 nm, approximately 320 nm, approximately 325 nm, approximately 330 nm, approximately 335 nm, approximately 340 nm, approximately 345 nm, approximately 350 nm, approximately 355 nm, approximately 360 nm, approximately 365 nm, approximately 370 nm, approximately 375 nm, approximately 380 nm, approximately 385 nm, approximately 390 nm, approximately 395 nm, or approximately 400 nm. In some embodiments, the emitted peak wavelength may be approximately 255 nm to approximately 275 nm (e.g., approximately 260 nm to approximately 270 nm, approximately 265 nm). In some embodiments, the emitted peak wavelength may be approximately 275 nm to approximately 295 nm (e.g., approximately 280 nm to approximately 290 nm, approximately 285 nm). In some embodiments, the emitted peak wavelength may be approximately 300 nm to approximately 320 nm (e.g., approximately 305 nm to approximately 315 nm, approximately 310 nm). In some embodiments, the emitted peak wavelength may be approximately 315 nm to approximately 335 nm (e.g., approximately 320 nm to approximately 330 nm, approximately 325 nm). In some embodiments, the emitted peak wavelength may be approximately 330 nm to approximately 350 nm (e.g., approximately 335 nm to approximately 345 nm, approximately 340 nm to approximately 350 nm, approximately 340 nm, approximately 345 nm). In some embodiments, the emitted peak wavelength may 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 may 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 may be (1) the ultraviolet A spectrum (e.g., 315 to 400 nm), and (2) the ultraviolet B spectrum (e.g., 280 to 315 nm) or the ultraviolet C spectrum (e.g., 100 to 280 nm, 200 to 280 nm, 240 to 280 nm).In some embodiments, the emitted peak wavelength is approximately 315 nm to 350 nm in the ultraviolet A spectrum (for example, approximately 320 nm to 345 nm, approximately 315 nm to 335 nm, approximately 330 nm to 350 nm, and approximately 340 nm to 350 nm).
[0104] In some embodiments, all light source channels in a light source array may emit light with 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 in a light source array may emit light with peak wavelengths 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 having different peak wavelengths (e.g., measured peak wavelengths) within a variation range. In some embodiments, the average peak wavelength across multiple light sources in a single light source channel may be the same as a particular peak wavelength of a particular light source within a single light source channel. In other embodiments, the average peak wavelength across multiple light sources in a single light source channel (e.g., about 1 nm, 2 nm, 3 nm, 4 nm, 5 nm or more, greater than or less than that) may differ from all specific peak wavelength differences of each light source within the 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., greater than or equal to) 5 nm, 10 nm, 15 nm, or 20 nm, or more. For example, in a non-limiting embodiment, the first light source channel may emit light having peak wavelengths of the ultraviolet A spectrum as described above (e.g., about 315 nm to about 335 nm, about 330 nm to about 350 nm, and about 340 nm to about 350 nm), and the second light source channel may emit light having peak wavelengths of the ultraviolet C spectrum as described above (e.g., about 250 nm to about 260 nm, and about 260 nm to about 270 nm), or 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 may emit light having peak wavelengths in the ultraviolet A spectrum as described above (e.g., about 330 nm to about 350 nm, about 340 nm to about 350 nm), and the second light source channel may also emit light having peak wavelengths in the ultraviolet A spectrum as described above (e.g., about 315 nm to about 335 nm, about 355 nm to about 375 nm). 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 may comprise first, second, and third light source channels, each emitting light of the 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., above) 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., above) 5 nm, 10 nm, 15 nm, or 20 nm or more. Alternatively, each of the first, second, and third peak wavelengths may differ from each other by at least (e.g., above) 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 of 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 each other by at least (e.g., above) 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 5 nm, 10 nm, 15 nm, or 20 nm or more (for example, above the following):Alternatively, the first peak wavelength may be approximately the same as the third peak wavelength (for example, equal to it with a variation range of ±1 nm, ±2 nm, ±3 nm, ±4 nm, ±5 nm), the second peak wavelength may be approximately the same as the fourth peak wavelength (for example, equal to it), and the first peak wavelength may differ from the second peak wavelength by at least (for example, 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 at half maximum (FWHM) spectral bandwidth of the light emitted by each light source channel (e.g., spectral bandwidth at maximum peak intensity) may 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 at 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 and not more than 10 nm shorter than the peak wavelength). In some embodiments, the full width at half maximum (FWHM) spectral bandwidth of the light emitted by each light source channel may be greater than 1 nm, greater than 2 nm, greater than 3 nm, greater than 4 nm, or more. In other embodiments, 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., not longer than 10 nm, not shorter than 10 nm; within 10 nm shorter than the peak wavelength; within 10 nm longer than the peak wavelength). In other embodiments, 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, less than 6 nm, or less than 5 nm (e.g., not longer than 10 nm, not shorter than 10 nm; within 10 nm shorter than the peak wavelength; within 10 nm longer than the peak wavelength). Commercially available LEDs and laser diodes are non-limiting examples of light sources that can provide illumination with such narrow spectral bandwidths at the peak wavelengths considered above.
[0106] In some embodiments, one or more of the peak wavelength of emission, the spectral bandwidth of emission, the duration of emission, and the intensity of emission for each light source channel 508 can be adjusted or set.
[0107] The adjustment of these various light source channel parameters may be performed by a control circuit 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” means any wired or wireless connection between two or more components that enables the exchange of information, control instructions, and / or control signals. As will be considered in more detail below, the control circuit 520 can receive control instructions and / or control signals from the computer system 524 and transmit control instructions and / or control signals to 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 various parameters of the chambers 502 and 504 may be desirable so that the processing parameters of the chambers conform to the processing profile of one or more biological fluids 510. It should be recognized that in some embodiments, the control circuit 520 and / or the functions of the control circuit 520 may be contained within the computer system 524. In some embodiments, the control circuit 520 may include the computer system 524 and / or the functions of the computer system 524. In some embodiments, the control circuit 520 may be structurally mounted 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 circuit 520 may be structurally integrated with the processing chambers 502 and 504 (e.g., located inside the processing chambers 502 and 504, or forming part of the structure of the processing chambers 502 and 504).
[0108] The computer system 524 can be operably coupled (wired or wirelessly) to the control circuit 520 and / or any of the various sensors considered herein. The computer system may include one or more processors 544 (544 in Figure 5, 644 in Figure 6), memory 542 (542 in Figure 5, 642 in Figure 6), input / output (I / O) interface 546 (546 in Figure 5, 646 in Figure 6), and user interface (UI) 548 (548 in Figure 5, 648 in Figure 6). One or more processors 544 may be one or more of any kind of general-purpose computer processor. The memory or computer-readable medium 542 may include one or more of readily available memories such as random access memory (RAM), read-only memory (ROM), floppy disks, hard disks, optical storage media (e.g., compact disks or digital video disks), flash drives, or other forms of digital storage, local or remote. In some embodiments, a non-temporary computer-readable storage medium in 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. The computer system 524 may encompass all types of computers, including personal computers (PCs), desktop computers, laptops, computer terminals, server computers, tablet computers, smartphones, and personal digital assistants (PDAs). In some embodiments, the control circuit 520 and / or the functions of the control circuit 520 may be included within the computer system 524.
[0109] In UI548, the user can input one or more properties from a set of properties of one or more biological fluids (e.g., biological fluid 510). Alternatively, one or more properties from a set of properties of one or more biological fluids may be determined based on feedback input to the computer system 524 and / or control circuit 520 from one or more sensors for the processing chambers (e.g., processing chamber 502, processing chamber 504). The set of properties of the biological fluid may include, for example, the type of biological fluid (e.g., blood products, 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), the volume of the biological fluid, the light transmittance of the biological fluid, the type and / or shape of the container holding the biological fluid, and the temperature of the biological fluid.
[0110] In UI 548, the user can input one or more parameters, including processing profiles for one or more biological fluids (e.g., biological fluid 510). Alternatively, the computer system 524 can automatically determine one or more parameters for one or more processing profiles of one or more biological fluids (e.g., biological fluid 510) based on each set of properties of one or more biological fluids. Specifically, memory 542 can store a computer program that includes instructions for mapping one or more properties of biological fluids to one or more parameters of the biological fluid processing profile for each biological fluid. The instructions for mapping one or more features of biological fluids 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, finned heat sink, or heat exchanger that is operably coupled and controlled by a control circuit 520). The heat exchanger 528 removes thermal energy from the array 506 facing one or more biological fluids 510, thereby minimizing the exposure of the biological fluids 510 to thermal energy (e.g., thermal energy that could damage biological functions). Further control of the temperatures of chambers 502 and 504 and / or the temperatures of one or more biological fluids 510 may be provided by a heating / cooling unit 526 that is operably coupled to and controlled by a control circuit 520 and can be configured to adjust or set the temperatures of chambers 502 and 504. The heating / cooling unit 526 may be 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 located outside, inside, and / or integrated with the chambers 502 and 504. For example, one or more fans may be positioned at the rear of the processing chamber(s) to draw air in from the inlet of the external housing of the system 500 and exhaust air from the exhaust port at the rear of the external housing.
[0112] In some embodiments, the heating / cooling unit 526 may 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 range of 1°C, 2°C, 3°C, etc.) during the treatment of the biological fluid by irradiation. For example, a thermal or temperature sensor may provide a temperature indication or measurement to the control circuit 520, or to the computer system 524 via the control circuit 520. If the control circuit 520 and / or the computer system 524 processes or interprets the temperature indication or measurement as indicating the crossover of a specific threshold or condition related to a target temperature value or profile, the control circuit 520 and / or the computer system 524 may instruct or command or enable or engage or act on the heating / cooling unit 526 to take action to adjust the temperature of chamber 502 or 504 and / or the temperature of one or more biological fluids 510. For example, the control circuit 520 and / or computer system 524 may instruct or command or enable or engage or act on one or more fans to start blowing air to initiate 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. During the processing of the biological fluid by irradiation, one or more fans may operate in operating cycles under the control of the control circuit 520 and / or computer system 524 to maintain the temperature of the biological fluid within a certain temperature range (e.g., a range of 1°C, a range of 2°C, a range of 3°C, etc.). The control circuit 520 and / or computer system 524 may instruct or command or enable or engage or act on any other suitable technology known in the art, or any combination of such technologies, such as fans, heat pumps, Peltier coolers and / or heat pipes, to take action to adjust the temperature of the chamber 502 or 504 and / or the temperature of one or more biological fluids 510.
[0113] In some embodiments, one or more fans may be located at the rear of the processing chamber(s). One or more fans can blow air from front to back, or from back to front, or both. In some embodiments, one or more fans can draw air in, pass it through the processing chamber, and expel it through an exhaust port at the rear of the system. Intake to one or more fans can enter through vents located at or near the front or side(s) of the processing chamber(s), and exhaust from one or more fans can exit through vents located at the rear of the processing chamber(s).
[0114] The processing chambers 502 and 504 may further include 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), each configured to absorb light. Alternatively or additionally, in some embodiments, the processing chambers 502 and 504 may further include one or more internal surfaces configured to reflect light (e.g., each configured to reflect light), each configured of a particular wavelength (e.g., 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 fluids). The platform 530 may be any support suitable for holding biological fluids or containers of biological fluids. The platform 530 may be arranged in a “drawer configuration” such that it is manually slidably moved in and out of the chambers 502 and 504. The platform 530 may be automatically slidably moved by any suitable actuator such as an electric motor or servo. The platform 530 holding the biological fluids 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 within processing chambers 502 and 504. One or more scanners 532 may be positioned over 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 illustrated, one or more scanners 532 (e.g., scanner 532C) may also be positioned outside the system 500 (e.g., external housing, outer surface) between the first and second processing chambers. 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 acquire identification information about the biological fluid as described herein. In some embodiments, one or more scanners may be positioned at the first opening of the first processing chamber 502, the second opening of the second processing chamber 504, or at the openings of both chambers.
[0117] Figure 6 is a perspective view of an exemplary system 600 for processing biological fluids. In some embodiments, system 600 is substantially similar to system 500 as shown in Figure 5. The exemplary system 600 for processing biological fluids 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 irradiate one or more biological fluids 610 from below; a second light source array 608 in each chamber arranged to irradiate 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., a container of biological fluids); and a sensor (e.g., a scanner) 632 configured to acquire identification information of the biological fluids placed in the processing chambers. The first light source array 606 and the 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 the ability to irradiate the biological fluids from one direction (i.e., above or below) or two directions (i.e., both).
[0118] System 600 may include a scanner 632A located outside System 600 (e.g., external housing, outer surface) at a location associated with the first processing chamber 602 (e.g., the opening of the first processing chamber 602 or near it), and a scanner 632B located outside System 600 (e.g., external housing, outer surface) at a location associated with the second processing chamber 604 (e.g., the opening of the second processing chamber 604 or near it). System 600 may also include a scanner 632C located inside System 600 (e.g., inner wall, ceiling, floor) between the first processing chamber 602 and the second processing chamber 604. In some embodiments, scanner 632C may be configured to acquire information from a container located inside either processing chamber or both processing chambers.
[0119] Figure 7 is a perspective view of an exemplary system 700 for processing biological fluids. In some embodiments, the system 700 is substantially similar to the system 300 shown in Figure 3 and the system 600 shown in Figure 6, differing in that a first processing chamber 702 and a second processing chamber 704 are arranged vertically (above and below each other) within the system 700. The exemplary system 700 for processing biological fluids 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 irradiate 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., a container of biological fluids); and a sensor (e.g., a scanner) 732 configured to acquire identification information of the biological fluid placed in the processing chamber. The platform 730 for holding the biological fluids 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 comprise a second light source array (not shown) positioned above or below one or more biological fluids 710, as shown in Figure 6, for example, similar to system 600.
[0120] System 700 may include scanners 732A and 732B positioned inside the first processing chamber 702 (e.g., on the ceiling above the compartments for biological fluids 710A and 710B) and two similarly positioned inside the second processing chamber 704 (e.g., on the ceiling above the compartments for biological fluids 710C and 710D). System 700 may also include scanner 732E positioned outside System 700 (e.g., on the outer housing, outer surface) between the first processing chamber 702 and the second processing chamber 704. In some embodiments, scanner 732E may be configured to acquire information from containers positioned inside 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, or when an RFID tag is within the detection range of scanner 732E).
[0121] Figure 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 located 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 located beneath 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 can each be operably coupled to a control circuit 818 from which their respective parameters can be adjusted or set. Figure 8B shows that the exemplary system 800 may also include a barrier (e.g., a light barrier, a protective barrier) 858 and various sensors 812, 866, 868, 880 within the processing chamber 812. In some embodiments, the barrier is transparent to light having wavelengths within 30 nm of a first peak wavelength (e.g., within 15 nanometers shorter than the first peak wavelength, within 15 nanometers longer than the first peak wavelength; not longer than 15 nanometers, not shorter than 15 nanometers) (e.g., substantially transparent, over 95% transparent, over 90% transparent, over 80% transparent, over 80% transparent). In some embodiments, the barrier is transparent to ultraviolet light, such as light having wavelengths in the ultraviolet A spectrum (e.g., substantially transparent, over 95% transparent, over 90% transparent, over 80% transparent, over 80% transparent). In some embodiments, the barrier is an optical barrier (e.g., an optical filter) configured to reduce the transmittance of light such as light having wavelengths less than the wavelength of light in the UVA spectrum (e.g., minimize, attenuate, block). In some embodiments, the barrier is an optical barrier configured to reduce the transmittance of light having wavelengths less than the wavelength of light in the UVB spectrum.In some embodiments, the barrier is an optical barrier (e.g., optical filter) configured to reduce (e.g., minimize, attenuate, block) the transmittance of light having wavelengths at least 20 nm shorter than the first peak wavelength (e.g., at least 25 nm shorter, at least 30 nm shorter) and / or other peak wavelengths (e.g., at least 20 nm shorter than the second, third, or fourth peak wavelength). In some embodiments, the barrier is an optical barrier (e.g., optical filter) configured to reduce the transmittance of light having wavelengths at least 20 nm longer than the first peak wavelength (e.g., at least 25 nm longer, at least 30 nm longer) and / or other peak wavelengths (e.g., at least 20 nm longer than the second, third, or fourth peak wavelength). The barrier 858 is positioned between the array of light sources 804 and the platform 810 (e.g., one or more biological fluids 806 and 808). Sensors 812, 866, 868 may be mounted on or positioned on the platform 810. The sensor 880 may be mounted on the barrier 858 (for example, above or below) or placed inside the barrier 858.
[0122] The light source array 804 may include an array of light source channels. Each light source channel of the light source array 804 may be configured to emit light of the various peak wavelengths described above in various arrangements of the light sources and light source channels described above.
[0123] Both the light source array 804 and the platform 810 may be configured to translate relative to each other to increase or decrease the distance 826 between them, as in the translation described above. The platform 810 may be lowered to the bottom of the processing chamber 812, and the processing chamber 812 may be raised from or at the same height as the external bottom surface (e.g., floor, ground, desk, etc.). The light source array 804 may be raised to the top of the processing chamber 812. In Figure 8B, the light source array 804, the barrier 858, and the platform 810 may all be configured to translate relative to each other to increase or decrease the distances 826, 882, and 884 between any pair of the light source array 804, the barrier 858, and the platform 810. This translation may be brought about by any number of actuators (e.g., electric motors, servos, etc.) controlled by a control circuit 818 that can control the translation of the light source array 804, the barrier 858, and the platform 810 separately. In some embodiments, one or two of the light source array 804, barrier 858, and platform 810 can be fixed in a predetermined position within the processing chamber 812. For example, the barrier 858 can be fixed in a position within the processing chamber 812. In another embodiment, the barrier 858 and the light source array 804 can be fixed in a predetermined position relative to each other at a fixed distance 882 within the processing chamber 812, which can be configured so that the platform 810 moves to increase or decrease the distances 826 and 884. In yet another embodiment, the barrier 858 and the platform 810 can be fixed in a predetermined position relative to each other at a fixed distance 884 within the processing chamber 812, which can be configured so that the light source array 804 moves to increase or decrease the distances 826 and 882.
[0124] As described above with respect to Figures 1-8(a and b), a biological fluid processing system (e.g., an electronic processing device) can include a number of components and systems that need to work together to safely and effectively process biological fluids. The above embodiments may show exemplary layouts of components used to process one or more biological fluids in a device in which two processing chambers are oriented horizontally to each other and / or the processing chambers are oriented perpendicular to each other. Figure 9 shows another exemplary internal hardware layout of a system for processing biological fluids according to an embodiment of the present disclosure. In an embodiment of the device 900, the processing chambers can be oriented perpendicular to each other so that the biological fluids can be positioned vertically within the device when the device is processing two biological fluids simultaneously.
[0125] The system (e.g., an electronic device for processing biological fluids) 900 may include two separate processing chambers 918 and 920 such that, in embodiments of the system 900, the processing chambers 918 and 920 can be oriented perpendicular to each other. In one or more embodiments, each processing chamber 918 and 920 may include one or more platforms (e.g., drawers) and associated trays 908, which are configured to transport the biological fluid (e.g., in a container) and make the biological fluid accessible to a user who can remove and / or place the biological fluid in the device. In one or more embodiments, the system 900 may be configured with agitators (e.g., motors, servos), such as an agitator configured (e.g., connected, coupled, integrated) on the platform 908, so that any biological fluid transported on the platform (e.g., drawers and associated trays) 908 can be agitated during processing. In one or more embodiments, each platform (e.g., drawer) 908 may be configured with an agitator (e.g., motor, servo) such as 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 may also include one or more modular optical device (e.g., optical engine) components 910. In one or more embodiments, the modular optical device component 910 of each processing chamber 918 and 920 may 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 placed inside each processing chamber (e.g., on a platform inside the processing chamber).
[0127] In one or more embodiments, as will be described in more detail below, the system (e.g., electronic device) 900 may 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, safety-critical components may refer to one or more components of the electronic device that interact with the biological fluid being processed, and improper operation of these components could jeopardize the safety and effectiveness of the processing process in the biological fluid (e.g., meeting required specifications). In one or more embodiments, the CSB 904 may be configured to communicate with and issue commands to each of the safety-critical components (described in more detail below) using a domain-specific, customized communication protocol configured to protect the safety-critical components from access by unauthorized (e.g., malicious) users, thereby enabling the device to be modular and scalable while minimizing operational disruption and / or maintaining regulatory compliance of the device. In one or more embodiments, the CSB904 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 apparatus components 910, since these components directly interact with biological samples, improper operation of these components may jeopardize the safety and / or effectiveness of the processing process. In one or more embodiments, the CSB904 can also be configured to move air through the electronic apparatus (e.g., draw air from the front to the back of the electronic apparatus) to cool the apparatus and the biological fluid being processed and to operate one or more fans 912 to prevent overheating. In addition to controlling each of the components, the system CSB904 can be configured to evaluate the results from each of the components and, in one or more embodiments, can communicate with them in a continuous manner.The CSB904 can be configured, for example, to stop stirring, start and / or stop lighting, or to use the results to determine subsequent operating steps of the apparatus to complete the processing process.
[0128] In addition to the processing chamber-specific components described above, in one or more embodiments, the electronic device 900 may include one or more components that are not specific to a particular processing chamber but are instead configured to operate the entire device and are therefore common to both processing chambers. In one or more embodiments, the electronic device 900 may 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 may be configured to coordinate the operation of one or more non-safety-critical hardware and software components (as described in more detail below). For example, in one or more embodiments, the UIC 902 may be configured to operate one or more graphical user interfaces displayed on a display 914. One or more graphical user interfaces may be configured to guide the user through the processing process, receive input from the user, and determine information about the biological fluid being processed and other information that the device may need to perform the processing process. In one or more embodiments, the display 914 may be implemented as a “touch display” in which the user can touch the surface of the display to input any input or otherwise interact with the device during the processing process.
[0129] In one or more embodiments, the UIC902 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 a container holding a biological fluid, including information related to the identification of the biological fluid and other information necessary to ensure proper handling of the material.
[0130] As shown in Figure 8B, the system may include multiple components and sensors that work together to deliver light to a sample for processing. For example, as described above with respect to Figure 8B, the processing chamber 812 may include a light source array 804 and one or more sensors 812, 866, 868, and 880 that work together to illuminate the sample during processing. In one or more embodiments of the present disclosure, the sensors 812, 866, 868, and 880, configured (configured in conjunction) to ensure that the biological fluid to be processed is uniformly irradiated with a precise amount (e.g., dose) of light and that the light sources and / or irradiation process operate at temperatures that do not overheat the entire apparatus, may include a mixture of light sensors (e.g., photodiodes) and temperature sensors (e.g., thermistors).
[0131] However, if one of the components working together to deliver ultraviolet light to the biological fluid fails, is upgraded, or reaches the end of its lifespan, simply replacing that component can be a difficult and complex 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 normal operation. For example, sensors may be positioned and configured relative to the light source array originally installed in the device, so replacing that light source array may require reconfiguring one or more sensors. For example, in the case 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 changing the position of the photodiodes, it may not be possible to accurately capture the light generated by the light source array and determine whether sufficient light is being delivered to the sample being processed. Or, or further, if one or more of the light source arrays 804 are replaced with different light source arrays, simply replacing the light source arrays may not be sufficient to return the electronic device to normal operation. For example, to upgrade or modify light sources (e.g., LEDs) within a light source array, such as incorporating different peak wavelengths, increasing light source efficiency, or changing beam width, it may be necessary to modify the photodiodes in the light sensor.
[0132] In addition to reconfiguring some or all of the components related to light irradiation, replacing a component(s) can require significant time and labor to electrically reconnect all the various components (i.e., light source arrays and sensors) and to ensure (e.g., verify) that the components interact with each other to ensure that the correct amount of UV light is irradiated onto 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 so that the components can reliably communicate with each other and operate the entire device in a safe and efficient manner.
[0133] Therefore, in one or more embodiments, if one of the components fails or is upgraded, the entire optical supply system can be replaced together, so it may be advantageous to house several or all of the components related to light irradiation (i.e., light source arrays, sensors, and other control electronics) in a single housing, so that each of the other components does not need to be reconfigured and reconnected to the replaced component. Returning to the embodiment in Figure 9, in one or more embodiments, each optical device 910 may include substantially all of the components and sensors related to delivering UV light to the biological fluid being processed. As will be described in more detail below, the optical devices can be made “modular” by providing standalone optical devices that include the sensors and components necessary for light irradiation, so that if one or more components of the optical device fail, are upgraded, or are nearing the end of their lifespan, the entire optical device can be replaced.
[0134] As shown in Figure 9, an electronic device for processing biological fluids may include four optical device components 910 and two platforms (e.g., and associated trays) 908. The number of optical device components 910 and platforms 908 shown in Figure 9 is intended as an example only and should not be considered limiting. An electronic device for processing biological fluids may include several of each component. In one or more embodiments of the present disclosure, each platform 908 (which holds the biological fluid for processing (e.g., a container containing the biological fluid) in use) may have two optical device components 910 directed toward it, one located above the platform and the other located below the platform, and the light source of each optical device component is directed toward (e.g., oriented) toward the platform and configured to irradiate a specific amount of UV light onto the biological fluid on the platform (e.g., and associated trays). Thus, in one or more embodiments, the optical device components 910 located above the platform 908 can be oriented such that the light produced by the components is oriented downward toward the platform 908, and the optical device components 910 located below the platform 908 can be oriented upward toward the platform 908. In this way, the platform (e.g., and associated tray) 908 that holds the biological fluid can be treated with UV light emanating from above and below. As described above, if any of the components of the optical apparatus components 910 malfunction or otherwise need to be replaced (e.g., upgraded), it would be advantageous to be able to easily replace a single unit housing all of the light-irradiating components rather than simply attempting to replace the faulty or upgraded component. Thus, in one or more embodiments of the present disclosure, the optical apparatus components can be housed in a single device configured to be modular and easily replaceable if any of the components malfunction or otherwise need to be replaced.
[0135] In one or more embodiments, the photodevice components 910 may be substantially identical in that they all contain identical components having the same configuration. However, in one or more embodiments, each set of photodevice components 910 (which can be housed in a single photodevice) may be configured differently from one another. For example, one of the photodevice components 910 associated with a given processing chamber may be configured to emit light of a specific peak wavelength (e.g., UV-A light), and another of the photodevice 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, the biological fluid on the platform 908 during the processing process may be treated simultaneously by two light sources emitting light of different wavelengths (e.g., peak wavelengths). Such a need may arise if the pathogen inactivation process is found to benefit from being treated with both UV-A and UV-B or UV-C light.
[0136] Figure 10 shows an exemplary modular optical device for use in a system (e.g., an electronic device) for processing biological fluids according to embodiments of the present disclosure. As shown in the embodiment of Figure 10 and as will be described in further detail below, the modular optical device 1000 can be configured to house substantially all of the components (e.g., light sources) and sensors (e.g., self-contained optical devices) necessary to generate light and irradiate the biological fluid being processed (e.g., a desired dose of UV light). In one or more embodiments of the present disclosure, the modular optical device 1000 may include a housing 1002 configured to house components within the optical device. In one or more embodiments, the housing 1002 may include a window portion (e.g., a transparent material portion, a translucent material portion) 1004 configured to allow a light source housed within the modular optical device 1000 to irradiate the biological fluid being processed (i.e., configured to allow light from the light source to pass through). In one or more embodiments, the window portion may 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 contaminants (e.g., biological fluids, dust). In one or more embodiments, the window portion may comprise a window material covering / surrounding the opening to the light source array chamber. In one or more embodiments, the window portion(s) 1004 (e.g., transparent material portion, transmissive material portion) 1004 may be configured to be UV-transmitting (e.g., made of a material selected to transmit or pass through light of a selected wavelength). In one or more embodiments, the window portion(s) 1004 (e.g., transparent material portion, transmissive material portion) 1004 may be made of a material (e.g., transparent material, transmissive material) such as glass, quartz-based, plastic, acrylic, or other polymer (e.g., thermoplastic) material, configured to transmit a significant amount of light energy generated by the device. In one or more embodiments, the window portion 1004 may be configured to be UV-transmitting (i.e., >50% transparent, >60% transparent, >70% transparent, >80% transparent, >90% transparent, >95% transparent).In one or more embodiments, the transmittance of the window portion 1004 can be correlated with the amount of light irradiated by the modular optical device 1000. Thus, in one or more embodiments, a modular optical device 1000 having a window 1004 with a transmittance of only 80% can be configured to generate light at a higher intensity than a window 1004 with a transmittance of 90% in order to irradiate a precise amount of light onto a biological fluid under treatment. In one or more embodiments, the window portion may consist of a flat (e.g., planar) window portion (e.g., window material). In one or more embodiments, the window portion may consist of a curved (e.g., convex, concave) material portion.
[0137] In one or more embodiments of the present disclosure, the window portion 1004 may include one or more photosensors (e.g., photodiodes) positioned on or across the window 1004 (e.g., facing a light source, light source array). In one or more embodiments, the window portion 1004 may include one or more circuits (e.g., cables, PCB traces, flexible circuit strips) 1006 positioned on or across the window 1004 (e.g., facing a light source, light source array(s)) and may be configured to support one or more photosensors (e.g., photodiodes facing a light source, light source array(s)). As will be described in more detail below, the photodiodes positioned on the circuits (e.g., flexible circuits) 1006 may be configured to measure the amount of light being irradiated by a light source, such as a light source array (e.g., an LED array) housed in a modular optical device 1000. In one or more embodiments, the photosensors may be implemented using any number of photosensing techniques, including, for example, UV phototubes and / or photodiodes. In one or more embodiments, each circuit is a flex circuit, and each flex circuit may cast a shadow on the optical path, so the width of the flex circuits may be, for example, about 5 mm or less, about 4 mm or less, or about 3 mm or less, in order to minimize any interference that may occur with respect to the light irradiated onto the biological fluid. The flex circuit 1006 may generate shadowing in the optical path of the modular optical device, but the shadowing (representing a noise source) may be modulated (i.e., averaged) in one or more embodiments by the agitation of the biological fluid in the processing chamber and / or the number and / or arrangement 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 the performance degradation associated with shadowing. In one or more embodiments, each of the three flex circuits can be configured to hold three light sensors (e.g., photodiodes) so that three flex circuits 1006 together can hold nine light sensors (e.g., photodiodes).Adding more light sensors (e.g., photodiodes) and / or flexible circuits may lead to more accurate measurement of the light produced by the modular optical device 1000, but it may also lead to more obstruction or interference of the light illuminating the biological fluid. Similarly, including fewer (i.e., fewer) light sensors (e.g., photodiodes) and / or flexible circuits may reduce the shadows produced by the flexible circuit 1006, but may lead to a loss of accuracy in the optical measurement. Therefore, the amount of photodiodes and flexible circuits can represent a design trade-off between measurement accuracy and shadowing of the light produced by the modular optical device 1000.
[0138] In one or more embodiments of the present disclosure, the modular optical device 1000 may include a light source array chamber / cavity (e.g., LED array chamber) 1008 located below (e.g., inside) the window 1004 and configured to hold a plurality of light sources (e.g., LEDs), sensors, and other components necessary to generate light for processing (discussed in more 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 (discussed in more detail below with respect to Figure 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 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 positioned on the sides of the chamber 1008 and configured to surround the light source array(s) (e.g., LED arrays) 1010. The reflectors 1012 can be configured to redirect the light generated by the light sources (e.g., LEDs) around the light source array (LED array) 1010 back toward the window (e.g., the central part of the window) 1004, thereby minimizing the loss of light energy at the edges of the light source array chamber (e.g., LED array chamber) 1008. Thus, light sources (e.g., LEDs) surrounding a light source array (or more) (e.g., an LED array) can direct light (e.g., some of the light) towards the walls of the light source array chamber (e.g., an LED array chamber) 1008 rather than towards the biological fluid being processed, and the reflector 1012 can redirect that light towards the window 1004 and back through the window 1004, so that the light is not wasted and can be used to process the biological fluid, thereby improving the overall efficiency of the light source array (or more) (e.g., an LED array) 1010.Therefore, while the reflector 1012 helps conserve potentially wasted light energy, it also ensures that the modular optical device 1000 reliably generates a more uniform amount of light (for example, across the entire device, across the surface of the biological fluid being treated, and within the irradiation dose).
[0139] In one or more embodiments of the present disclosure, the modular optical device 1000 may include one or more interfaces (e.g., ports) for electrically connecting the modular optical device to various components of an electronic processing unit. In one or more embodiments, the modular optical device 1000 may include an interface panel 1014 located on the side of the housing 1002. The interface panel 1014 may include one or more interfaces for electrically connecting the modular optical device 1010 to various components of an electronic processing unit. In one or more embodiments, the interface panel 1014 may include an interlock connector 1016. When connected to an electronic device, the interlock connector 1016 may be configured to allow the electronic device to quickly and efficiently shut down the modular optical device if the device encounters a condition, failure, or situation in which continued operation of the modular optical device 1010 is undesirable. For example, if the electronic device detects a problem with the biological fluid being processed (i.e., the biological fluid is not properly loaded into the tray or processing chamber) or if it detects a malfunction in the agitator, the device can quickly shut down the modular optical device 1000 using 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 optical device 1000 to the power supply of an electronic processing unit. In this way, the modular optical device 1000 does not need to bear its own power supply, and instead can be connected to the power supply of the electronic processing unit when the modular optical device 1000 is installed in the electronic processing unit. In one or more embodiments of the present disclosure, the power port 1018 may be configured to connect an external power supply to an internal component of the electronic processing unit that requires power, such as a light source (e.g., an LED) or a sensor. In one or more embodiments, the power port 1018 may be configured to transmit power from the external power supply to one or more controllers / drivers (described in further detail below) which can be configured to distribute power to various components within the modular optical device 1000. In one or more embodiments, the power port 1018 may be rated at 48V, and the modular optical device itself may be configured to consume approximately 225W of power.
[0141] In one or more embodiments, the interface panel 1014 may include a communication port, such as an Ethernet® port 1020. The Ethernet® port 1020 may be configured to provide networking capabilities to the modular optical device 1000 when connected to the device. As will be described in more detail below, the Ethernet® port may allow the modular optical device to communicate with other safety-critical components within the electronic device using a special domain-specific communication protocol configured to isolate safety-critical components of the electronic device from interference from external sources.
[0142] In one or more embodiments of the present disclosure, the modular optical apparatus 1000 may include a heat exchanger 1022 located at the bottom (e.g., base) of the housing 1002. As will be described in more detail below, in order to maintain the modular optical apparatus, processing chamber and / or biological fluid at a desired operating temperature (e.g., within a desired operating temperature range), the heat exchanger may be shaped and configured to reduce or remove heat generated by various components of the modular optical apparatus away from the modular optical apparatus (e.g., away from the biological fluid).
[0143] Figure 11 shows a top view of an exemplary modular optical device 1100 for use in a system for processing biological fluids according to embodiments of the present disclosure. Figure 11 further shows the components found within the light source array chamber (e.g., LED array chamber) 1008 of Figure 10. As shown in Figure 11, the modular optical device 1100 may include multiple light sources, such as UV LEDs 1102 configured to generate UV light during operation of the modular optical device 1100. In one or more embodiments, multiple LED light sources 1102 of the light source array(s) may be distributed on one or more panels 1108. For example, in the embodiment of Figure 11, the light source array chamber (e.g., LED array chamber) 1008 may include three panels 1108 arranged in the internal base of the chamber, and the LED light sources 1102 may be arranged across the three panels such that some of the LED light sources are located on each panel 1108. The number of light sources (e.g., LEDs) 1102 within the light source array chamber 1008 may depend on many factors. In one or more embodiments, each modular optical device 1100 of the electronic processing apparatus may be configured to generate light over the entire surface of a processing bag or other processing container (e.g., containing the biological fluid) at a specific depth of the biological fluid in the processing bag and / or around a predetermined irradiation dose (e.g., the fluid contained within the predetermined irradiation dose) surrounding the processing bag. In one or more embodiments, the predetermined irradiation dose may represent a three-dimensional space around a platform (e.g., and associated trays) to which a substantially uniform amount of light is delivered by the optical device. Thus, at a predetermined irradiation dose, the modular optical device may be configured to provide a substantially uniform amount of light according to a predetermined specification. The size of the irradiation dose and the intensity of the light that needs to be irradiated at the irradiation dose may serve as factors in determining the number of light sources (e.g., LED light sources) included in each modular optical device 1100.
[0144] In one or more embodiments, the uniformity of light within the irradiation dose can be quantified as a function of the irradiance of the light source. Therefore, in one or more embodiments, multiple light sources can be collectively configured such that the light sources illuminate the biological fluid in the processing chamber with a variation in irradiance across the entire surface of the biological fluid (e.g., liquid container, liquid container barrier) facing the light sources less than 25% (e.g., less than 20%, less than 15%, less than 10%). In some embodiments, the light sources are positioned at any 5 cm above the biological fluid in the processing chamber (e.g., the container containing the biological fluid) 2 The area is configured to be irradiated with a variation of less than 25% from the integrated irradiance (averaged over the surface area) of the entire biological fluid (e.g., the container containing the biological fluid) shielding surface.
[0145] In one or more embodiments, the surface of the biological fluid may 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 may be configured (e.g., arranged in an array) to illuminate the biological fluid with a variation of less than 25% (e.g., less than 20%, less than 15%, less than 10%) from the overall irradiance of the biological fluid surface facing the array of light sources. In other words, the light intensity at any portion of the biological fluid surface facing the array of light sources may differ by less than 25% (e.g., less than 20%, less than 15%, less than 10%) from the light intensity at any other portion of the biological fluid surface facing the array of light sources.
[0146] In one or more embodiments, the modular optical device 1100 may include 216 LEDs 1102 within the LED array chamber 1008. In one or more embodiments, the LED array chamber 1008 may include more or fewer LEDs. In addition to the requirements of irradiation dose and processing process, the number of LEDs may 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 optical device 1000, and the desired processing time of the biological fluid to be processed. For example, the desired UV treatment dose for the biological fluid may be 6.3 J / cm² from a desired combination of processing time and intensity. 2 In one embodiment, 216 LEDs can provide the required amount of light. However, in one or more embodiments, using fewer LEDs and / or lower intensities in the modular optical device can reduce the power required, but may require more time for the biological fluid to be processed. Conversely, using more LEDs and / or higher intensities in the chamber can shorten the processing time, but the power and temperature costs may increase in relation to the increased number of LEDs and / or higher intensities. In one or more embodiments of the present disclosure, the modular optical device 1000 may 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 optical device 1000 may include, for example, 50 to 400, 100 to 300, or 150 to 250 light sources (e.g., LEDs) within the light source array chamber 1008, with a total of 500 or fewer, 400 or fewer, 300 or fewer, 250 or fewer, 200 or fewer, 150 or fewer, or 100 or fewer light sources.
[0147] In one or more embodiments of the present disclosure, as shown in Figure 11, the light source array chamber (e.g., LED array chamber) may include one or more photosensors (e.g., photodiodes) 1104 disposed on a printed circuit board (or more) on which the LEDs themselves are arranged. In addition to the photodiodes disposed on the flexible circuit (or more) 1006 described above, a photodiode 1104 may be included (a photodiode 1104 disposed on the flexible circuit (or more) 1006 can be seen in the diagram provided by Figure 12). In contrast to the photodiodes disposed on the flexible circuit (or more) 1006, the photodiode 1104 can be oriented to capture light transmitted by a second modular optical device located on the opposite side of the processing chamber (e.g., platform, processing bag) from the modular optical device 1000, and can therefore be configured to measure light transmitted by the second modular optical device. As described above, the photodiode on the flexible circuit 1006 can be oriented and configured to capture light transmitted directly toward the processing chamber (e.g., platform, processing bag) by the modular optical device itself.
[0148] In one or more embodiments, the modular optical device 1100 can include nine photodiodes 1104 disposed on the printed circuit board(s) (e.g., three per circuit board) of the optical array chamber 1008 and another nine (e.g., three per flex circuit) 1006 disposed on the aforementioned flex circuit(s), for a total of eighteen photodiodes. The number of photodiodes included in any modular optical device can 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 optical device. Thus, in one or more embodiments, the modular optical device can include more photodiodes to improve measurement accuracy, but this may sacrifice, for example, a narrower spacing of components or an increase in the volume of the optical engine. Conversely, the modular optical device 1000 can include fewer photodiodes, which can, for example, reduce the footprint of the entire optical device but sacrifices measurement accuracy. In one or more embodiments of the present disclosure, the modular optical device 1000 can include two or more, four or more, six or more, eight or more, ten or more, fifteen or more, twenty or more, twenty-five or more, or thirty or more photodiodes (e.g., disposed on either or both of the aforementioned printed circuit board(s) and flex circuit(s)). In one or more examples, the photodiodes can be connected to control electronics (described in further detail below) such that the device can take corrective action (e.g., warn the operator of the status, adjust the intensity of the light source, adjust the current to the light source, end the processing process) if it is determined that the modular optical device is not generating an appropriate amount of light (or if the other modular optical device in the processing chamber is not generating an appropriate amount of light). Alternatively, or additionally, in one or more embodiments, the photodiodes can be connected to control electronics (described in further detail below) such that the presence or absence of a biological fluid in the processing chamber can be determined based on the amount of light transmitted by a modular optical device on the opposite side of the processing chamber.
[0149] In one or more embodiments, the optical array chamber 1008 of the modular optical device 1000 may include one or more temperature sensors 1106. The temperature sensors 1106 may be configured to measure the temperature of the modular optical device 1000. During operation of the modular optical device, the light source (e.g., LED) can generate a considerable amount of thermal energy in addition to transmitting light energy. The temperature sensors 1106 may be configured to measure the heat emitted by the LED light source to confirm that the LED light source is operating according to its specifications and / or the specifications of the bioprocessing profile. In one or more embodiments, the temperature sensors may be connected to control electronics (described in more detail below) so that the optical device can be shut down or other corrective measures can be taken if it is determined that the modular optical device is operating at a temperature exceeding its specifications. In some embodiments, the LED light source may be modulated in response to temperature measurements by the sensor(s), for example, by cycling between on and off (e.g., pulse modulation). The temperature sensors (e.g., each temperature sensor) 1106 can be mounted, for example, at the LED junction (i.e., the junction between the LEDs and the PCB on which the LEDs are placed), since a large portion of the LEDs are the source of heat generated by the optical device. Alternatively, or in addition to the above, the temperature sensors (e.g., each temperature sensor) 1106 can be mounted, for example, on the printed circuit board of the light array chamber 1008. In one or more embodiments, the temperature sensors can be implemented using thermistors (or any other components configured to measure temperature changes) whose resistance can change in proportion to the temperature of the light array chamber 1008. Furthermore, one or more temperature sensors can be implemented using various types of sensors, such as thermocouples, infrared sensors, bimetallic devices, thermometers, state change sensors, and silicon diodes. In one or more embodiments, the modular optical device 1000 may include a total of six temperature sensors.Similar to the photodiode 1104, the light array chamber 1008 can contain several temperature sensors (e.g., one or more, two or more, three or more, four or more, five or more, eight or more, or ten or more). A larger number of temperature sensors results in higher measurement accuracy, but may come at the expense of space. Conversely, fewer temperature sensors may require less space, but may result in lower measurement accuracy.
[0150] Figure 12 shows a side view (cross-sectional view) of an exemplary modular optical device for use in a system for processing biological fluids (e.g., an electronic processing device) according to an embodiment of the present disclosure. A side view 1200 of the optical device 1000 provided in Figure 12 can better illustrate some additional features of the optical device according to one or more embodiments of the present disclosure. For example, as shown in side view 1200, the optical device 1000 includes a control circuit 1202 contained within the housing of the optical device 1002 (for illustrative purposes, the housing 1002 of the control circuit has been removed to reveal the control circuit). The control circuit 1202 may include both a controller PCB 1204 and one or more light source (e.g., LED) driver PCB 1206. In one or more embodiments of the present disclosure, the controller PCB 1204 may be configured to function as the “brain” of the optical device. In one or more embodiments of the present disclosure, the controller PCB 1204 may be configured to facilitate communication between a broader processing device and the optical device 1000 itself and to operate one or more LED PCBs 1206. In one or more embodiments of the present disclosure, the controller PCB1204 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 adjust 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 optical device 1000 can include two LED driver PCBs 1206, and each driver includes 18 driver chips configured to collectively adjust the current and power of 216 LEDs 1102 disposed within the illumination array chamber 1008. In one or more embodiments, the LED driver PCB 1206 can be configured to ensure that the optical device 1000 complies with the IEC61010 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 a function of the number of LEDs 1102 disposed within 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 optical device. In another exemplary embodiment of the optical device 1000, a control circuit including the controller PCB 1204 and the LED driver PCB 1206 can be integrated into the CSB controller of the entire system described above. However, integrating these control units into the optical device 1000 itself can make the design more modular in that replacing (e.g., upgrading) the optical device would not only require accessing the system-wide CSB controller for upgrading the control electronics associated with the optical device 1000, but could be a simple matter of replacing the entire unit.
[0152] The side view 1200 in Figure 12 may also be useful in showing the beam angles 1208 of individual light sources (e.g., LEDs) arranged on the LEDPCB 1206. In one or more embodiments, the beam angle of an LED can represent the angle at which the light produced by the LED is distributed or emitted. As described above, the LED arrangement can be greatly influenced by the desired illumination surface area or volume of the processing bag. Therefore, in one or more embodiments, LEDs with appropriate beam angles 1208 can be selected to meet the illumination specifications. In one or more examples of this disclosure, the selected beam angle may be about 120°, but the angle can be larger or smaller (e.g., about 100° to about 140°, about 110° to about 130°, about 115° to 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 in each LED that can focus light to a desired beam angle. Furthermore, the side view 1200 may be useful in showing a photosensor 1212 (e.g., a photodiode) of a flexible circuit(s) 1006, positioned on a window 1004, facing a light source(s) on a light source array(s) of a modular optical device, and detecting light emitted therefrom.
[0153] Figure 13 shows a bottom view of an exemplary modular optical device for use in a system for processing biological fluids (e.g., an electronic processing device) according to embodiments of the present disclosure. The bottom view 1300 of the optical device 1000 provided in Figure 13 can better illustrate a heat exchanger 1302 which can be configured to remove heat generated by the optical 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 in or blown out 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., blown in) from or to the fan(s) passing through the heat exchanger 1302 moves to the air passing from the optical device 1000, creating an effect of lowering the overall temperature of the light source array and / or modular optical device.
[0154] As shown in the embodiment of Figure 13, in one or more examples, the heat exchanger 1302 can be formed as fins of a specific height and width, but a larger height and width can be selected to maximize the surface area exposed to the blowing air, and as the height and width increase, the size of the footprint of the entire optical device increases, and therefore the height and width of the heat exchanger 1302 may be constrained by any size requirements imposed on the optical device. The shape of the heat exchanger 1302 can be configured to allow air to pass through the exchanger and be drawn in or blown over 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, instead of using air to transfer heat from the modular optical device 1000, the optical device 1000 may include other forms of active cooling, such as active cooling that circulates a liquid (e.g., around the heat exchanger 1302) to cool the optical device 1000. In one or more embodiments, the optical device 1000 may also be cooled using passive cooling, and one or more heat exchangers 1302 may be configured to cool the optical device 1000 using natural conduction, convection, and radiation.
[0156] As shown above, in one or more embodiments of the present disclosure, the modular optical device 1000 may include a plurality of heat sinks configured to exchange heat with air passing over them, provided by one or more fans located outside the optical device (i.e., on the processing unit). However, as will be discussed later, in one or more embodiments, the optical device 1000 may include its own fans, which may be housed inside the optical device and become part of the modular structure.
[0157] Figure 14 shows an exemplary fan structure for implementing a photodevice for use in a system for processing biological fluids according to an embodiment of the present disclosure. In another embodiment, as shown in Figure 14, the modular photodevice 1402 may include one or more fans 1404 as part of the photodevice. In embodiments of the photodevice 1402, one or more fans 1404 may be configured to blow or draw air through a light source array chamber, for example, through multiple internal heat sinks or heat exchangers configured to exchange heat from the LEDs of the photodevice. Including fans as part of the photodevice can lead to a more modular design, as additional components operating the photodevice 1402 are co-located within a single photodevice. This can lead to more efficient modularization, as the photodevice itself can more directly control its own cooling mechanism.
[0158] However, in one or more embodiments, including one or more fans as part of the modular optical device 1402 can also increase the overall weight and size of the optical device. For example, as shown in Figure 14, an optical device 1406 that does not include one or more fans as part of the optical device may have a smaller footprint than an optical device 1402 that includes fans as part of the optical device. As an example, an optical device 1402 that includes an internal fan 1404 may have a greater height and weight than an optical device 1406 that does not include an internal fan. Therefore, using a “fanless” design in which the optical device relies on an external fan (such as a fan that is a component of an electronic processing unit) or passive cooling can make the optical device smaller and lighter, and the design of the optical device can be made more modular (i.e., easily replaceable). In one or more embodiments, a modular optical 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 optical devices (i.e., to allow for easy removal and replacement of optical devices in case of failure, failure to function according to the desired operation, or upgrade), the electronic processing unit itself can be configured to support the modularity of the optical devices. In other words, the processing unit can be configured to mechanically support modular optical devices and facilitate their easy removal or addition. Configuring the processing unit to facilitate the efficient removal and replacement of optical devices makes the replacement of optical devices more efficient, so that the user working with the machine simply "slides out" the modular optical device (e.g., from the side, front, or rear) and "slides in" the replacement, requiring only a minimum number of electrical connections (e.g., power, Ethernet®, the interlocks mentioned above).
[0160] Figure 15A shows another diagram of an exemplary internal hardware layout of a system for processing a biological fluid (e.g., an electronic processing device) according to an embodiment of the present disclosure. Figure 1500 in Figure 15A represents a side view (e.g., a cross-sectional view) of the processing device. In one or more embodiments, when a modular optical device is replaced, the side panel of the processing device can be removed as shown in Figure 15A, thereby providing access to one or more modular optical devices permanently located within the device. As shown in side view 1500 in Figure 15A, the processing device 1502 may include four separate modular optical devices 1504, 1506, 1508, and 1510. As in the embodiments described above, the optical devices 1504 and 1506 may be configured and positioned to provide substantially uniform light (e.g., UV light) to a processing platform 1512 (e.g., and associated trays) and the biological fluid placed on the platform. The optical devices 1508 and 1510 can be configured and positioned to provide substantially uniform light (e.g., UV light) to the processing platform 1514 (e.g., and the biological fluid placed thereon).
[0161] In one or more embodiments, the electronic processing unit 1502 may 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 into them so that the optical device is mechanically supported by the processing unit. In one or more embodiments, each set of rails 1516, 1518, 1520, and 1522 may include two rails positioned on either side of the electronic device. Figure 15 shows a single rail for each set of rails 1516, 1518, 1520, and 1522. The second rail of each set is positioned on the opposite side of the electronic device and is not visible in the figure. Thus, in one or more embodiments, a track provided on the housing of a modular optical device 1504 can be slid into the rails 1516 of the processing unit 1502 (e.g., from the side of the processing unit 1502) to mechanically support the optical device 1504. The track on the housing of optical device 1506 can slide onto the rail 1518 of the processing unit 1502 to mechanically support optical device 1506. The track on the housing of optical device 1508 can slide onto the rail 1520 of the processing unit 1502 to mechanically support optical device 1508. Finally, the track on the housing of optical device 1510 can slide onto the rail 1522 of the processing unit 1502 to mechanically support optical device 1510. By providing the processing unit with a set of tracks that complement a set of rails for each modular optical device, the replacement of modular optical devices becomes an efficient and easy process, allowing the optical devices to be slid into the processing unit during replacement.
[0162] Figure 15B shows another exemplary diagram of a modular optical device according to an example of the present disclosure. Figure 1524 of Figure 15B may help to show a track 1526 of an optical device (discussed above with respect to Figure 15A) configured in one or more embodiments to slide on one of the rails 1516, 1518, 1520, and 1522 of a processing apparatus 1502 to mechanically support the optical device 1508. As shown in Figure 1524 provided by Figure 15B, the track 1526 can be shaped to couple with the rails so as to prevent the optical device from sliding or moving laterally once the track 1526 is positioned on the rails 1516, 1518, 1520, and 1522 as it slides on the rails 1516, 1518, 1520, and 1522.
[0163] In one or more embodiments of the present disclosure, modular optical devices may be subjected to a test process (e.g., a health check process) to ensure that each modular optical device within the electronic processing unit is operating according to its requirements, that there are no obstructions or other occlusions (e.g., dust, scratches, dirt, etc.) in the optical device windows, and / or that there are no obstructions in the optical path on the processing unit platform (e.g., associated trays). In one or more embodiments, the test process (e.g., a health check process) may be performed when one or more optical devices are first installed / replaced in the processing unit, and / or may be performed intermittently throughout the operating life of the devices (e.g., before each processing process). In one or more embodiments, the test process may be performed to determine the presence or absence of a biological fluid to be processed (e.g., a container having the biological fluid) (e.g., in a processing chamber, on the platform of the electronic processing unit).
[0164] Figure 16 shows an exemplary modular optical apparatus test process in an embodiment of the present disclosure (for example, to determine whether there are obstructions in the window and / or platform or other occlusions (e.g., contamination) that prevent light from completely and / or evenly illuminating the sample being processed). In one or more embodiments of the present disclosure, the process 1600 shown in Figure 16 may be initiated in step 1602, and one or more processors associated with the optical apparatus itself or with the processing apparatus may generally initiate a check process for the optical apparatus and / or processing apparatus. In one or more embodiments, the test process for the optical apparatus and / or electronic processing apparatus (e.g., a health check process) may be initiated when there is no biological fluid being processed in the apparatus and no biological fluid loaded onto the platform (e.g., on an associated tray). Thus, the health check process for the optical apparatus is performed during times when no processing is taking place and does not interfere with the overall processing process, nor does the presence of biological fluid placed on the platform interfere with the health check process.
[0165] Once the process begins in step 1602, process 1600 proceeds to step 1604, where both optical devices associated with a single platform (e.g., the associated tray) (see description above) are both turned off (e.g., if currently on) so that neither light device transmits light. Once both optical devices associated with the platform are turned off or shut off in step 1604, process 1600 proceeds to step 1606, where the first of the two optical devices is activated. As will be apparent from the description below, by turning on only one optical device at a time to perform the health check, it is possible to know the exact light source being measured during the health check. In contrast, if both optical devices were activated simultaneously during the health check, it could be difficult to determine or accurately measure where the measured light is coming from.
[0166] Once the first optical device is activated in step 1606, process 1600 proceeds to 1608, where light coming from the first optical device (e.g., passing through the platform of the processing chamber) can be measured using a photodiode on the second optical device. As described above, one or more photodiodes placed directly on an optical array (e.g., an LEDPCB) are oriented to specifically capture light transmitted from another optical device on the opposite side of the platform (e.g., and associated trays). In contrast, one or more photodiodes placed on the flexible circuit (described above) can be oriented to measure light transmitted by the optical device itself. In one or more embodiments of the present disclosure, a photodiode on the flexible circuit of the first optical device can also measure light coming from the same (e.g., the first) optical device.
[0167] In step 1608, once the light transmitted by the first optical device is measured by the second optical device, the process proceeds to step 1610, where the light source (e.g., LEDs) of the first optical device may be shut off. Once shut off, the process proceeds directly to step 1616 (described later) or step 1612, where the light source (e.g., LEDs) of the second optical device is activated (e.g., to check the health of the second optical device and / or electronic device). Once the second optical device is turned on in step 1612, process 1600 proceeds to step 1614, where the light transmitted by the second optical device (e.g., passing through the platform of the processing chamber) may be measured by one or more photodiodes of the first optical device in substantially the same manner as the process described above in steps 1606-1610. In one or more embodiments of the present disclosure, photodiodes on the flexible circuit of the second optical device may also measure light coming from the same (e.g., second) optical device.
[0168] In step 1614, when light from the second optical device is measured by the first optical device, process 1600 proceeds to step 1616, where a determination is made regarding the health of the optical device(s) and / or electronic device(s) (e.g., platform) based on the measurements obtained in steps 1608 and 1614. In one or more embodiments, if one or more of the optical devices or electronic devices are determined to have failed the health test, the processing unit may send an alert to the user in the form of a graphical user interface (GUI) displayed on the processing unit's display. After the health of the optical device(s) is determined in step 1616, process 1600 proceeds to step 1618 and terminates.
[0169] The process described above with respect to Figure 16 can determine the integrity of each modular optical device and whether light from each optical device is transmitted (e.g., through) to the platform (e.g., and associated trays) holding the processing container. In one or more embodiments, the above integrity check may not be sufficient to determine whether the desired dose (e.g., illumination) is achieved. For example, the process described above with respect to Figure 16 may not be able to measure (e.g., a proper measurement) the total dose (e.g., to the surface of a biological fluid, the measured irradiation dose) because the process is configured to determine whether the light source (e.g., LED) of each optical device is transmitting light or whether there is occlusion blocking the transmitted light. Therefore, in one or more embodiments, calibration procedures can be performed intermittently throughout the operating lifecycle of the optical devices to determine whether the individual and / or combined optical devices are providing the desired amount of light (e.g., whether they are producing an appropriate illumination dose or an appropriate irradiance). Based on such calibration procedures, adjustments can be made, for example, by increasing the intensity of one or more light sources (e.g., LEDs) to compensate for the decrease in light efficiency over time. In one embodiment, such an increase in intensity allows the device to maintain a substantially constant processing time (e.g., the time experienced by the operator) throughout the entire lifecycle of the light source.
[0170] Figure 17A shows an exemplary optical apparatus calibration process according to an embodiment of the present disclosure. Process 1700 can utilize a calibration device that can be implemented as a component (e.g., independent of the modular optical device, independent of the electronic device) configured to be placed on the platform of the apparatus (e.g., and associated trays), and Process 1700 comprises a plurality of photodiodes or other photosensors that can measure the amount of light received from one or both modular optical devices and calculate various factors including the total dose irradiated (e.g., irradiation dose). In one or more embodiments, Process 1700 for calibrating an optical apparatus can begin in step 1702, where the calibration device is placed on the platform (e.g., associated trays) of the processing apparatus (typically holding the biological fluid / processing vessel during the operation of the processing apparatus).
[0171] In one or more embodiments, once the calibration device is positioned on the platform in step 1702, process 1700 proceeds to step 1704, in which one or more optical devices configured to illuminate the platform are activated (i.e., the LEDs of the optical device(s) are turned on and light is transmitted to the calibration device). After one or more optical devices are activated in step 1704, process 1700 proceeds to step 1706, in which one or more optical measuring devices of the calibration device (i.e., photodiodes) can record measurements of the light received from one or more optical devices. In one or more embodiments, once the measurements are taken in step 1706, process 1700 proceeds to step 1708, in which the calibration device (or a processor connected to the calibration device) can calculate illuminance (e.g., dose, irradiation dose). In one or more embodiments, in step 1708, the calibration device can send a display to the user of the device indicating whether the device received an appropriate dose during the test or whether the test failed. Once the illuminance is calculated in step 1708, process 1700 proceeds to step 1710 and terminates.
[0172] FIG. 17B shows another exemplary calibration process according to an embodiment 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. Thus, reference may be made to the descriptions of steps 1702, 1704, and 1706 above to understand the details of steps 1714, 1716, and 1718, respectively. In one or more embodiments, when an optical measurement value is obtained in step 1718, process 1714 may proceed to step 1720, where the measurement value obtained in step 1718 can be compared with a predetermined threshold value (e.g., a predetermined dose). In one or more embodiments, the predetermined threshold value can represent a value indicating that the current processing time required by the device for pathogen inactivation is not appropriate (e.g., insufficient irradiation, insufficient dose) if the measurement value obtained in step 1718 is below it. In one or more embodiments, the predetermined threshold value can be determined empirically. In one or more embodiments, the calibration device can obtain the measurement value and transmit the measurement value to a processing device or a modular optical device (e.g., via an electronic device) to perform the comparison in step 1720. Additionally or alternatively, the calibration device itself can perform the comparison in 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), adjustments can be made to the light emitted by one or more light sources of the optical device, for example, based on communication between the electronic device and the optical device. In one or more embodiments, in response to a calibration test in which the measurement obtained in 1718 falls below a predetermined threshold in step 1720, the device can extend the processing time to compensate for the lower amount of light received by the biological fluid during the processing process. However, in one or more embodiments, extending the processing time may be undesirable because it may reduce the overall efficiency and productivity of the processing device. Therefore, in one or more embodiments, if the measurement obtained in step 1718 falls below a predetermined threshold in step 1720, in one or more embodiments, the process 1714 can proceed to step 1722, and the intensity of the light source used during the calibration process 1714 (e.g., the light source of the optical device) can be adjusted (i.e., increased) to account for (e.g., compensate for) a lower amount of light. In this way, there is no need to increase the processing time to account for the low light output from the light source, and the intensity of the light source can be increased, thereby keeping the processing time substantially constant throughout the life of the optical device. In embodiments in which the calibration device performs the comparison described with respect to step 1720, then in one or more embodiments, the calibration device may send an instruction to the electronic device to adjust the intensity as described above with respect to step 1722.
[0174] A modular optical device can be considered a safety-critical component insofar as a failure or malicious operation of the optical device could lead to failure (e.g., failure to meet specified criteria) or a hazardous processing process. In one or more embodiments, if a modular optical device fails, or if a malicious user gains direct control of the optical device, the biological fluid being processed is deemed unsafe for use. Accordingly, as will be described in detail below, the above-described modular optical device can be configured to operate with a wider range of electronic processing devices and can be configured to be compatible with one or more features of the processing devices described below (such as safety features, modular component aspects, and / or domain-specific communication protocols).
[0175] Figure 18 shows an exemplary system diagram of an illumination system (e.g., an electronic processing device) for processing biological fluids according to embodiments of the present disclosure. In one or more embodiments, the biological fluids processed by System 1800 may include one or more of platelets, plasma, blood, and blood products. As described above with respect to Figures 1-3, the device can process the biological fluids by irradiating them with light (e.g., ultraviolet light), such as having wavelengths in the ultraviolet-A (UV-A), UV-B, and / or UV-C spectra in one or more embodiments. To process fluids using light, the device can be configured to irradiate the biological fluid with light (e.g., ultraviolet light, UVA light) at a specific intensity for a predetermined time (e.g., to achieve a desired dose) for the purpose of inactivating pathogens. In one or more embodiments, the device can process a biological fluid mixed with a pathogen inactivation compound (e.g., a photoactive compound) with light (e.g., UV light).
[0176] In one or more embodiments of the present disclosure, the system 1800 may include a control module 1816 and a processing module 1802. In one or more embodiments of the present disclosure, the processing module 1802 may include two subsystems, namely (1) a primary subsystem 1804 and a safety subsystem 1814. In one or more embodiments of the present disclosure, the primary subsystem 1804 may include components and systems that perform optical processing (e.g., UVA optical processing), while the safety subsystem (described in detail below) may include components and systems configured to monitor the activities performed by the primary subsystem 1804.
[0177] In one or more embodiments, the primary subsystem 1804 may include one or more modular optical devices 1806, each comprising a light source(s) (e.g., a light source array(s)) for processing a biological fluid. Each modular optical device 1806 may include one or more light sources, which can be configured to emit light of variable intensity (e.g., UVA light) and which are positioned within the device such that the biological fluid within the device is exposed to light (e.g., light waves) emitted from the light sources when the light sources are emitting. In some embodiments of the present disclosure, the biological fluid may be contained in a container (e.g., a bag) and may be placed within a device such as a platform (e.g., and associated trays) and may be exposed to 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 containers (e.g., bags) containing the biological fluid to be processed. The processing containers may be placed on a platform (e.g., associated product tray) 1808 within the processing chamber. Each processing chamber may have one or more modular optical devices associated with it. For example, each chamber may receive light (e.g., UVA light) from one or more optical devices 1806 to process the biological fluid in the processing container within the processing chamber. In another embodiment, processing can be performed simultaneously on multiple processing containers (e.g., bags) in multiple processing chambers.
[0179] In some examples, the primary subsystem may include a stirrer 1810. The stirrer 1810 may be used to agitate the contents of the processing vessel to distribute (e.g., evenly distribute) the biological fluid and / or pathogen inactivating compound into the biological fluid (e.g., by mixing). The primary system may further include various components 1812 to perform various other functions to support the processing process. These functions include, but are not limited to, one or more sensors (e.g., to detect light, light intensity, or light quantity), detection of the placement of the processing vessel, and marking mechanisms to indicate that processing has been performed in a particular processing vessel.
[0180] In some examples of this disclosure, a safety subsystem 1814 within the processing module 1802 can be used to monitor processing activity occurring in the primary subsystem 1804. The functions of the safety subsystem 1814 may include, but are not limited to, interlocks, lockouts, and hardware and software watchdogs.
[0181] In some embodiments, the irradiation processing system 1800 may include a control module 1816 that allows a user to make processing requests and interact with the illumination system 1800. In some embodiments, the control module 1816 may be physically separated from the illumination system 1800. If physically separated, the control module 1816 may be connected to the illumination system 1800 wirelessly using a wired connection or 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 illumination 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, and barcode reading camera.
[0183] In one or more embodiments of the present disclosure, the system 1800 may 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 for 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 subsystem is triggered by input to the user interface 1818. In some embodiments, communication between the control module and the subsystem is triggered by the introduction of the subsystem or component into the lighting system (e.g., a modular optical device is installed in the system).
[0185] The modules, components, and systems described above may include various components related to their respective functions. These components can be arranged in a system architecture that allows them to be coordinated with one or more biological fluids to facilitate the effective and efficient processing of those components.
[0186] Figure 19 shows another exemplary system diagram of a lighting system for processing biological fluids according to an embodiment of the present disclosure. In some embodiments of the present disclosure, the system architecture 1900 may include a control module 1916 and a processing module 1902. The control module 1916 may include a control subsystem 1920 that can perform various functions. For example, the control subsystem 1920 may manage graphic icons, screen transitions, button presses, and other user interactions on the user interface 1918. It may print a record of the processing that has occurred. It may function as a communication manager by interacting with an external network of the lighting system 1900, for example, via Ethernet®. In one or more embodiments, the control subsystem 1920 may also function as a data manager by maintaining a database of the processing that has been performed. In one or more embodiments, the control subsystem 1920 may also function as an event log manager by recording different events that occur in (e.g., internally and / or externally) 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 outside the lighting system 1900 can be connected to the control subsystem 1920 via port 1926. These devices may include, but are not limited to, an external personal computer or an external blood management system for sending and receiving data to and from the lighting system 1900. For example, the blood management system can collect reports from the lighting system 1900. It can also transmit software and data to the lighting system 200 to perform different control functions. These functions may include, but are not limited to, programming the lighting system 1900 with different processing profiles and user information, and performing maintenance and health checks (e.g., diagnostics) of the lighting system 1900.
[0188] In one or more embodiments, the control module 1916 can be isolated from the processing module 1902 with the help of a common interface 1922 (described in further detail below). For example, such isolation may help to physically separate critical functions of the processing module 1902 from 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 makes it possible to place safety-critical software and hardware that require more rigorous testing in the processing module 1902 and non-critical software and hardware in the control module 1916. In this way, the impact of replacing or changing non-critical components with critical components of the device can 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 within the control module 1916 (which may be implemented as a controller in one or more embodiments) can communicate with a separate controller 1924 within the processing module 1902.
[0190] In one or more embodiments, the control subsystem 1920 can be communicatively coupled to one or more non-safety-critical components located within the control module 1916, and can also be communicatively coupled to the processing module 1902 via the controller 1924. The controller 1924 within the processing module 1902 can be communicatively coupled to one or more safety-critical components such as the optical device 1928 and the stirrer 1910, and can also be communicatively coupled to the control subsystem 1920 in the control module 1916.
[0191] In one or more embodiments, the sole interface of the control subsystem 1920 to the components of the processing module 1902 may be via the controller 1924, while the sole interface of the controller 1924 to the components in the control module 1916 may be via the control subsystem 1920. In this way, isolation can be maintained between the non-security-critical components in the control module 1916 and the security-critical components in the processing module 1902. By maintaining this isolation using two separate controllers, the impact on the processing module 502 caused by future changes to the components in the control module 1916 (i.e., changes or expansions to the components) can be minimized. Thus, changes to the control module 1916 do not have to involve the cumbersome retesting of the 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 can be maintained between the non-security-critical components in the control module 1916 and the processing module 1902. The domain-specific interface protocol 522 used for communication between the control subsystem 1920 and the controller 1924 may represent a way for the two modules 1916 and 1920 to maintain consistency despite changes in the components constituting the control module 1916 and the processing module 1902.
[0192] In one or more embodiments, 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 an interlock or lockout mechanism if an unsafe or inappropriate condition is detected. The controller 1924 may also implement alarms programmed to indicate errors occurring during the processing process and to display alarm information to the user via the user interface 1918. In some embodiments, the controller 1924 may also perform processing tasks by managing different components within the illumination 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 the biological fluid) is exposed to by controlling the on / off times and light intensity of the modular optical device 1906. In some examples, the controller 1924 may also control the wavelength of light emitted by the optical device and / or the speed of the stirrer 1910. In some embodiments, the controller 1924 may be a single-board computer with a processor or a custom printed circuit board. 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 optical device 1906, a controller 1924, a user interface 1918, and a control subsystem 1920, but each component has 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 may run an algorithm that manages the interactions between all components to perform a processing process. In some embodiments, the smart component of the optical device 1906 may have an algorithm for monitoring the delivered light (e.g., UV) energy and adjusting the processing time and dose rate. Furthermore, the light device 1906 may be able to receive instructions and commands from the controller 1924. In some embodiments, the computing hardware of the smart component 1928 may be implemented using a custom printed circuit board, FPGA, or ASIC and may include volatile and non-volatile memory.
[0194] In one or more embodiments of the present disclosure, the lighting system 1900 may include one or more sensors (not shown). For example, a modular optical device 1906 may include an optical sensor (e.g., a photodiode) that detects the amount (e.g., total dose) of light (e.g., light energy) emitted by a light source (e.g., from an LED) within the optical device 1906 and / or the amount (e.g., light energy) of light irradiating a biological fluid in a processing vessel. Other examples of sensors include, but are not limited to, proximity sensors, weight sensors, air sensors, and temperature sensors.
[0195] In some examples, system 1900 is an electronic device for processing biological fluids, and common interface 1922 is the processing interface for the electronic device. In some examples, the control modules of the system (e.g., control module 1016, control module 1916) include a first controller and a second controller. Through the processing interface, the first controller can be communicatively coupled to several non-safety-critical components, such as those described herein, and the second controller can be communicatively coupled to several safety-critical components, such as those described herein.
[0196] In some embodiments, multiple non-safety-critical components are communicatively coupled to a processing interface, and in response to multiple safety-critical components being communicatively coupled to a processing interface, the system uses a control module to detect multiple non-safety-critical components and multiple safety-critical components within the electronic device.
[0197] In some examples, the system can send a first message relating to a non-security-critical component between a first controller and a non-security-critical component via a processing interface, and the system can send a second message between a second controller and a security-critical component via a processing interface. In some embodiments, the first and second messages are based on a domain-specific interface language, for example, TCP / IP. In some embodiments, in response to receiving a message, the controller module or component can send a response to the sender to acknowledge receipt of the respective message (e.g., message accepted, message rejected, message missing information, recipient busy).
[0198] In some embodiments, the system determines the state of non-safety-critical components based on a first message and the state of safety-critical components based on a second message. For example, the state may be one or more of “Not Initialized,” “Initializing,” “Ready,” “Running,” “Calibrating,” “Shutting Down,” “Serving,” and “Failed.” 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 relating to one or more commands, a transaction number, a message type, and a message size. The message data may include information relating to one or more of the conditions described herein.
[0200] In some embodiments, the message may include information about the system. For example, system information may include the processing volume related to the biological fluid being processed, the maximum processing time for the biological fluid, the maximum retention time after processing is complete, the data update interface (e.g., how often the system is notified of the processing progress), and the speed of the components (e.g., agitator current speed (Hz)). It should be understood that the information listed is illustrative and not limiting. In some embodiments, the information in the message may be user-defined parameters (e.g., information derived from user-defined processing parameters).
[0201] In some embodiments, the message may include information about the process. For example, the information about the process may include the elapsed time of the process, the irradiation dose, the chamber temperature, the biological fluid temperature, and the speed of the components (e.g., the agitator current speed (Hz)). It should be understood that the information listed is illustrative and not limiting.
[0202] In some embodiments, 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 is complete (e.g., processing has finished) and data related to the completed processing (e.g., statistics).
[0203] In some embodiments, a message may be associated with a service in the system. In some embodiments, a message may be a request to start a service in the system. In some embodiments, a message may contain information about a service currently running on the system (such as maintenance). In some embodiments, a message may contain information about a completed service (e.g., notifications, service logs).
[0204] In some embodiments, messages can be associated with 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, messages can be associated with system failures (e.g., identification of a faulty component, instructions for failure recovery, logs related to the failure). In some embodiments, messages can be associated with system calibration (e.g., transfer of calibration files, transfer of configuration files). In some embodiments, messages can be associated with subsystem or component versions (e.g., interface version, firmware version, OS version, BIOS version, hardware version, component version, subsystem serial number). For example, messages associated with subsystem or component versions can be used to verify that the system's safety, reliability, or compatibility requirements are up-to-date.
[0205] In some embodiments, a non-safety-critical or safety-critical component may change state. For example, a non-safety-critical or safety-critical component is in a first state. The system may change the state of the non-safety-critical or safety-critical component from the first state to a second state (for example, in response to user input). In some embodiments, in response to the state change, the system sends a second message (for example, different from the first message) from the non-safety-critical or safety-critical component to the control module via a common interface. In some embodiments, the system receives the second message at a first or second controller, and in response to receiving the second message, the system determines a second state for the processing component.
[0206] In some cases, power is supplied to the system, and in response to the power supply to the system, the presence of several non-safety-critical components and several safety-critical components is detected. For example, the presence of these components is detected during power-up and system initialization.
[0207] In some embodiments, in response to power being supplied to the system, the system assigns local network addresses (e.g., IP addresses, MAC addresses) and ports (e.g., TCP ports) to several non-security-critical components and several security-critical components. In some embodiments, the local network addresses and ports are based on a domain-specific interface language. For example, the local address may be an IP address or a MAC address, and the local port may be a TCP port.
[0208] Figure 20 shows an exemplary system diagram of a system for processing biological fluids according to an embodiment of the present disclosure. System example 2000 in Figure 20 can serve as an additional exemplary system diagram with respect to the embodiments provided above with respect to Figure 19. In one or more embodiments, system 2000 may include a user interface controller 2002 that can interface with one or more safety-intensive components of the apparatus. In one or more embodiments, the safety-intensive components may 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. The safety-intensive components may refer to components within system 2000 that do not directly interact with one or more biological fluids processed by the apparatus and whose operation does not substantially affect the safety and effectiveness of the processing process.
[0209] In one or more embodiments, the UIC2002 can control and interact with one or more components of a system accessible by an external user of the device. For example, in one or more embodiments, the UIC2002 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 UIC2002 can control or interact with one or more barcode scanners 2010 configured to scan one or more barcodes associated with a biological fluid (e.g., on a container associated with a biological fluid) and containing identification information about the biological fluid. In one or more embodiments, the UIC2002 can interact with an Ethernet® port 2012 that can be configured to allow the device to connect to an external computing network (such as the Internet or an enterprise computing system), and the device can be controlled or accessed externally by a computer connected to the device via the Ethernet® port 2012. In one or more embodiments, the UIC2002 can be configured to control and interact with one or more Universal Serial Bus (USB) ports 2014. USB port 2014 allows external devices such as a mouse or keyboard to be connected to system 2000.
[0210] In one or more embodiments, the UIC2002 may interact with one or more externally facing components (i.e., components that can be controlled by a user or device that are not part of the system), but the user or device cannot directly control one or more safety-critical components 2018 of the device. As described in detail below, the UIC2002 may communicate with a control system board (CSB) 2006 that can be configured to receive commands from the UIC2002 and translate those commands into one or more actions performed by one or more safety-critical components 2018.
[0211] In one or more embodiments of the present disclosure, the system 2000 may include a network switch 2004 capable of routing transmissions between components of the system by receiving data using packet switching and forwarding it to specific components within the system. In one or more embodiments, the network switch 2004 may be configured to receive one or more packets (including commands or information) from the UIC 2002 to the CSB 2006. For example, the UIC 2002 may receive one or more inputs from an external user via a 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 user input. In one or more embodiments, the network switch 2004 may also receive one or more packets from the CSB 2004 and route one or more packets to one or more safety-critical components 2018 (associated with a processing module that may include both processing chambers 2020 and 2022) to operate the safety-critical components for processing biological fluids in the processing chambers 2020 and 2022.
[0212] As briefly described above, each of the processing chambers 2020 and 2022 may include one or more safety-critical components 2018. Safety-critical components 2018 may refer to sensors and hardware used by the apparatus to process one or more biological fluids. In one or more embodiments, safety-critical components included in each processing chamber include a modular optical device module 2024, a temperature sensor 2026, a platform (e.g., drawer) latch sensor 2028, a set detection sensor 2030, a tray position sensor 2032, a platform (e.g., drawer) 2034, a platform (e.g., drawer) lock 2036, and a stirrer 2038.
[0213] In one or more embodiments, the modular optical device module 2024 includes one or more light sources (e.g., UV light sources) and a photosensor configured not only to deliver light (e.g., UV light) to the biological fluid but also to monitor the amount of light irradiated to and / or received by the biological fluid. In one or more embodiments of the Disclosure, safety-critical components 2018 may include a stirrer that can be configured to agitate the contents of the processing vessel to distribute (e.g., evenly distribute) the biological fluid and / or the pathogen inactivating compound in the biological fluid (e.g., in a mixture). In one or more embodiments, the stirrer 2038 may include a mechanical stirrer (e.g., a motor, a servo) configured to agitate the biological liquid or the photoactive pathogen inactivating compound in the biological liquid (e.g., in a mixture). In one or more embodiments, safety-critical components may include a platform (e.g., drawer) lock 2036 configured to lock or unlock (i.e., prevent the platform (e.g., drawer) from opening) the platform (e.g., drawer) of the processing chamber based on a command from the CSB 2006.
[0214] Safety-critical components 2018 may further include a number of sensors configured to provide information about the operation of the apparatus to the CSB2006. In one or more embodiments, a temperature sensor 2026 may be configured to monitor the temperature of the system and / or the biological fluid and to transmit updates indicating the temperature of the biological fluid and / or the apparatus to the CSB2006. In one or more embodiments of the present disclosure, a platform (e.g., drawer) latch sensor 2028 may be configured to detect whether a latch (e.g., a lock) on a platform (e.g., a drawer) of the apparatus (as described in detail above) is in an open or closed position and to transmit a signal indicating the position of the latch to the CSB2006. In one or more examples, a set (e.g., a processing set, a fluid processing set) detector sensor 2030 may be configured to detect whether a container (e.g., a bag) containing the biological fluid is on or in a platform (e.g., a drawer, an associated tray) and / or in a processing chamber and to transmit a signal indicating the presence or absence of such containers (e.g., bags) to the CSB2006. In one or more embodiments of the present disclosure, the tray position sensor 2032 may be configured to determine the presence of a tray and / or the position of a tray in a device (as described in detail above), such as the position (e.g., movement) of a tray within a tray and / or platform (e.g., a drawer), and may be configured to transmit a signal to the CSB2006 indicating the position of the platform / tray / drawer. In one or more embodiments, the platform (e.g., a drawer) and / or associated sensor 2034 may be configured to determine the position of the platform (e.g., a drawer) in a processing chamber (e.g., whether the platform (e.g., a drawer) is in a closed position within the processing chamber), and may be configured to transmit a signal to the CSB2006 indicating the position of the drawer.In one or more examples, “tray” may refer to a removable part or component of the platform that contains the biological fluid during processing, and which may be transparent, for example, on one or more surfaces such as the tray floor (e.g., bottom) (e.g., completely or partially transparent to allow light to pass through). In one or more embodiments, the term “drawer” may refer to a platform and associated frame that holds the tray and can secure the agitator motor. In one or more embodiments, the drawer may be configured to present the tray to the operator. In one or more examples, the tray may be agitated during processing, for example, by moving it linearly back and forth within the platform (e.g., the drawer).
[0215] In one or more embodiments of the present disclosure, the CSB2006 may be configured to communicate directly with the device's power button to turn the device on or off, and subsequently issue commands to each of the safety-critical components 2018 to stop or start their operation. The system 2000 may also include a power supply 2040 that can be used to provide electrical signals to each of the components within the system 2000 to power their operation.
[0216] As shown in Figure 20, system 2000 may include two separate controllers, UIC2002 and CSB2006, to control non-safety-critical components and safety-critical components 2018, respectively. By including two separate controllers, system 2000 can minimize the impact of unauthorized or erroneous operation of the device by an external user or device on the operation of safety-critical components 2018. To further isolate safety-critical components, for non-safety-critical components, UIC2002 may be configured to communicate with non-safety-critical components using a first communication protocol, while CSB2006 may communicate with safety-critical components using a second communication protocol different from the first communication protocol. In one or more embodiments, system 2000 may further utilize system-specific domain-specific communication protocols to communicate with and command safety-critical components 2018. In the embodiment of Figure 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 security-critical components respond only to commands sent from the CSB2006. Thus, the UIC2002, configured to control all externally facing components (i.e., components accessible to external users or devices), cannot be used to directly control security-critical components 2018, thus enhancing the security layer of the processing process. Therefore, in one or more embodiments, if a user inputs into one of the non-security-critical components, such as a touch display 2008, and the command requires an action from one of the security-critical components 2018, the command can be sent from the UIC2002 to the CSB2006 via the network switch 2004. In one or more embodiments, the network switch 2004 may be optional and not required. Once the CSB2006 receives the desired action from the UIC2002, it can use the TMI protocol to generate one or more commands for the security-critical components 2018 to operate these components according to the desired action registered by the UIC2002.
[0218] To facilitate the above interactions, the TMI protocol may, in one or more embodiments, be configured to identify the sender / originator of any packet so that the packet recipient can determine whether the command originated from CSB2006. In one or more embodiments of this disclosure, the TMI protocol may be configured to allow only commands originating from CSB2006 to act on security-critical component 2018. Thus, the security-critical component may be configured to accept only TMI packets from CSB2006.
[0219] In one or more embodiments, the TMI protocol can be configured as a custom communication interface capable of serving as a message and command forwarding interface between the CSB2006 and components of the processing module. The TMI can be configured to support security and cybersecurity (as described above) by separating security-critical functions from security-critical functions. In addition to supporting security, the TMI protocol can also be configured to enable the modularity and scalability of the device, thereby improving the reliability and testability of the device. In one or more embodiments, the TMI protocol can relay communications written to the protocol using Ethernet®, UDP / IP transport media.
[0220] Figure 21 shows 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 biological fluids.
[0221] In one or more embodiments, the process shown in diagram 2100 can be initiated by a user 2102 issuing a command to the device to start 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 may 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 the user to input their desired actions to the electronic device, which the device can then operate on based on those commands.
[0222] In one or more embodiments, when the user interface 2104 receives a command 2116 from user 2102, the user interface 2104 can convert the user's command into a command 2118 that is specially formatted to be compatible with the user interface controller (UIC) 2106 (as described in detail above). Upon receiving the command 2118, the UIC 2106 can process and validate the command as shown in 2120. If the command 2118 received by the UIC is successfully validated (i.e., the command is appropriate and, in one or more embodiments, authenticated), the UIC 2106 can send a signal 2122 to the user interface 2104, thereby providing user 2102 with an indication via interface 2104 that processing has been successfully initiated.
[0223] In one or more embodiments, after processing and verifying the received command 2118, the UIC 2106 may generate and transmit a command 2124, formatted using a domain-specific TMI communication protocol (as described above with respect to Figure 20), which is configured to alert the system controller 2108 and to operate the user's desired electronic device. In one or more embodiments, the TMI-formatted command 2124 may include information about the sender of the command 2124 (in this case, the UIC 2106), and the system controller may be configured to accept only commands that initiate processing transmitted by the UIC 2106. When the system controller 2108 receives a TMI-formatted message 2124 from the UIC 2106, the system controller 2108 may process and verify the command as shown in 2126.
[0224] In one or more embodiments, once the system controller 2108 processes and verifies 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 processing process. In one or more embodiments, components 2110, 2112, and 2114 may represent safety-critical components located within the processing chamber of the apparatus, and in one or more embodiments, may include optical device components, agitators, platform / tray / drawer locks, and sensors discussed in detail above with respect to Figure 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, commands 2128, 2132, and 2136 may be formatted using a domain-specific TMI communication protocol known only to the components within the electronic apparatus. Furthermore, commands 2128, 2132, and 2136 generated using the TMI communication protocol may include information about the origination of the command (in this case, the system controller 2108), and each of components 2110, 2112, and 2114 may be configured to respond only to commands that are determined to have originated from the system controller 2108.
[0225] In one or more embodiments, the system controller 2108 can generate a TMI message 2128 to a first component of the processing chamber 2110, indicating the action the component should take and identifying the source of the message. Once the first component 2110 receives the command 2128, it can process and verify the command in 2130 to ensure that the command is not only appropriate but also originated from the system controller 2108. If the component 2110 determines that the command 2128 is inappropriate or that it cannot determine that the command 2128 originated from the system controller 2108, the component can send an error warning message to the system controller 2108 (not shown). However, if the command is properly verified and authenticated, in one or more embodiments, the component 2110 can perform the action indicated by the message 2128. Once the component 2110 has performed the action, it can generate a message 2144, formatted using the TMI protocol, to inform 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 processing chamber 2112, indicating the action the component should take and identifying the source of the message. Once the second component 2112 receives the command 2132, it can process and verify the command in 2134 to ensure that the command is not only appropriate but also originated from the system controller 2108. If component 2112 determines that the command 2132 is inappropriate or that it cannot determine that the command 2132 originated from the system controller 2108, component 2112 can send an error warning message to the system controller 2108 (not shown). However, if the command is properly verified and authenticated, in one or more embodiments, component 2112 can perform the action indicated by message 2132. Once component 2112 has performed the action, it can generate a message 2140, formatted using the TMI protocol, to inform 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 a third component 2114 of the processing chamber, indicating the action the component should take and identifying the source of the message. Once the third component 2114 receives the command 2136, the 2138 can process and verify the command to ensure that it is not only appropriate but also originated from the system controller 2108. If the component 2114 determines that the command 2136 is inappropriate or that it cannot determine that the command 2136 originated from the system controller 2108, the component 2114 can send an error warning message to the system controller 2108 (not shown). However, if the command is properly verified and authenticated, in one or more embodiments, the component 2114 can perform the action indicated by the message 2136. Once the component 2114 has performed the action, it can generate a message 2142, formatted using the TMI protocol, to inform the system controller 2108 that the requested action has been performed.
[0228] The embodiment in Figure 21 shows a communication process for a device including three components 2110, 2112, and 2114, but this embodiment can be readily applied to devices having any number of components without departing from the methods and processes described above with respect to Figure 21. 21. Therefore, components 2110, 2112, and 2114 are for illustrative purposes only and should not be considered limiting.
[0229] In one or more embodiments, when the system controller 2108 receives messages 2140, 2142, and 2144 from components 2110, 2112, and 2114, the system controller 2108 can process and verify the received messages at 2146, and then generate a TMI-format message 2148 indicating that processing is complete (e.g., processing is finished) and send it to the UIC 2106. In one or more embodiments, when the UIC receives the message 2148 indicating that processing is complete from the system controller 2108, it can send a message 2150 (in either TMI format or another format understood by the display) to the 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 in Figure 21, the 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 (recognized only internally by the apparatus) and only commands generated by the system controller 2108, the possibility of malicious users or other external actors issuing commands to the apparatus without authorization is minimized. In one or more embodiments, the TMI communication protocol can be further configured to facilitate the introduction of new or replacement components in the processing chamber with minimal disruption to the apparatus, so that the system controller can detect new components and ensure that only it can issue commands to operate them.
[0231] In one or more embodiments, the TMI communication protocol can function as a message and command transfer 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, minimizes modifications due to misuse, isolates errors between components, and allows events to be reported to the device in an efficient manner. In one or more embodiments, the TMI communication protocol can transfer messages back and forth between various components of the device using commercially available transport protocols such as Ethernet® or UDP / IP.
[0232] Figure 22 shows an exemplary method 2200 for operating an exemplary system for processing biological fluids according to embodiments of the present disclosure. In some embodiments, method 2200 can be performed using the apparatus or system disclosed herein.
[0233] Method 2200 includes coupling a non-safety-critical or safety-critical component to a processing interface (step 2202). For example, referring to Figures 18 and 19, one of the non-safety-critical or safety-critical components is communicatively coupled to common interface 1822 or 1822.
[0234] This method includes using a controller to detect the presence of non-safety-critical or safety-critical components in an electronic device in response to coupling of non-safety-critical or safety-critical components to a processing interface of a safety-critical component (step 2204). For example, referring to Figures 18 and 19, the presence of non-safety-critical or safety-critical components is detected in response to coupling performed in step 2202.
[0235] This method includes sending messages based on a domain-specific interface language between the controller and non-security-critical or security-critical components via a processing interface (step 2206). For example, referring to Figures 18 and 19, messages are sent between a coupled component and a controller module as disclosed herein.
[0236] This method includes determining the state of a non-safety-critical or safety-critical component based on a message (step 2208). For example, referring to Figures 18 and 19, the state of the coupled component disclosed herein is determined based on the message transmitted in step 2206.
[0237] While a common interface is described for systems containing 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, non-safety-critical components, safety-critical components, and a common interface (e.g., a processing interface for an electronic device for processing biological fluids). Interactions between a control module and non-safety-critical or safety-critical components using a common interface may be substantially similar to the common interface interactions between the control module, non-safety-critical components, and safety-critical components described herein. For brevity, interactions between a control module and non-safety-critical or safety-critical components are not described. It is understood that all such variations are within the scope of this disclosure.
[0238] Figure 23 shows an embodiment of a computing device according to one embodiment. Device 2300 may be a host computer connected to a network. Device 2300 may be a client computer or a server. As shown in Figure 23, device 2300 may be any suitable type of microprocessor-based device, such as a personal computer, workstation, server, or handheld computing device (portable electronic device) such as a telephone or tablet. The device may include, for example, one or more of the following: processor 2302, input device 2306, output device 2308, storage 2310, and communication device 2304. Input device 2306 and output device 2308 may generally correspond to those described above and may be connectable to or integrated into the computer.
[0239] The input device 2306 may be any suitable device that provides input, such as a touchscreen, keyboard or keypad, mouse, or voice recognition device. The output device 2308 may be any suitable device that provides output, such as a touchscreen, haptic device, or speaker.
[0240] Storage 2310 may be any suitable device that provides storage, such as electrical, magnetic, or optical memory including RAM, cache, hard drive, or removable storage disk. Communication device 2304 may include any suitable device that can send and receive signals over a network, such as a network interface chip or device. Computer components may be connected in any preferred way, for example, via a physical bus or wirelessly.
[0241] The software 2312, which is stored in the storage 2310 and can be executed by the processor 2310, may include, for example, programming that embodies the functions of the present disclosure (e.g., embodied in the device described above).
[0242] The software 2312 may also be stored and / or transported in any non-temporary computer-readable storage medium for use by or in connection with an instruction execution system, device, or apparatus, such as those described above, which can retrieve instructions associated with the software from the instruction execution system, device, or apparatus and execute those instructions. In the context of this document, the 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, device, or apparatus, 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, device, or apparatus, such as those described above, which can take instructions associated with the software from or execute those instructions. In the context of this disclosure, the transport medium may be any medium on which the programming can be communicated, propagated, or transported for use by or in connection with an instruction execution system, device, or apparatus. Transport-readable mediums include, but are not limited to, wired or wireless propagation media of electrons, magnets, light, electromagnetics, or infrared rays.
[0244] The device 2300 may be connected to a network which may be any preferred type of interconnected communication system. The network may implement any preferred communication protocol and may be protected by any preferred security protocol. The network may include network links in any preferred configuration that can implement the transmission and reception of network signals, such as wireless network connections, T1 or T3 lines, cable networks, DSL, or telephone lines.
[0245] The device 2300 can implement any operating system suitable for operation over a network. The software 2312 can be written in any suitable programming language such as C, C++, Java®, or Python. In various embodiments, application software embodying the functions of this disclosure can be deployed in different configurations, for example, in a client / server configuration, or via a web browser as a web-based application or web service.
[0246] In one embodiment, 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 being configured to carry one or more biological fluids; one or more modular optical devices, each optical device being configured to irradiate a biological fluid; and one or more safety components configured to monitor the 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 and second controllers 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 are provided above, those skilled in the art will understand that other variations may be used. Furthermore, while features may appear to be described in relation to specific embodiments, those skilled in the art will recognize that various features of the described embodiments can be combined. Moreover, aspects described in relation to a particular embodiment may also be described independently.
[0248] In some embodiments, any of the processing systems and apparatus described above can be used to inactivate pathogens(s) in one or more biological fluids, including, for example, a biological fluid mixed with a pathogen inactivating compound (e.g., a photoactive pathogen inactivating compound, psoralen). Specifically, any of the processing systems and apparatus described above can irradiate a mixture of one or more pathogen inactivating compounds and a biological fluid, for example, blood or blood products (e.g., platelet compositions, plasma compositions, and derivatives thereof), with light of a specific wavelength (e.g., ultraviolet light) to induce a photochemical reaction and inactivate pathogens(s) that may be present in the biological fluid, for example, viruses, bacteria, parasites, and other contaminants, for example, cellular contaminants (e.g., leukocytes). In some embodiments, the pathogen inactivating compound targets nucleic acids to photochemically form adducts and / or crosslinks. For example, the apparatus of the present disclosure may be used in a method for processing a biological fluid, the method comprising providing a biological fluid mixed with a photoactive pathogen inactivating compound (e.g., psoralen, amotosalen) and irradiating the biological fluid with 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), e.g., ultraviolet light, emitted from one or more first light sources, the irradiation of the biological fluid occurring for a duration and intensity sufficient to inactivate pathogens in the biological fluid. In some examples, the apparatus of the present disclosure may be used in a method for processing a biological fluid, the method comprising irradiating the biological fluid with ultraviolet light (e.g., UV-A, UV-B, UV-C) emitted from one or more first light sources, the irradiation of the biological fluid being carried out for a duration and intensity sufficient to inactivate pathogens in the biological fluid. In some embodiments, each of one or more first light sources emits light having a full-width half-power (FWHM) spectral bandwidth of less than 20 nanometers. In some embodiments, each of 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., small molecule organic compounds, that can be used to inactivate pathogens that may be present in biological fluids, e.g., blood or blood products. Pathogen inactivating compounds that are “photoactive,” “photoactivating,” “photochemical,” or “photosensitizing” compounds are suitable compounds that require some level of light to sufficiently inactivate the pathogens. Such compounds are preferred in the inactivation of pathogens in biological preparations 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 psoralen, isoaloxazine, alloxazine, phthalocyanine, phenothiazine, porphyrin, and merocyanine 540. In some embodiments, the pathogen inactivating compound is psoralen. In some embodiments, the pathogen inactivating compound is amotosalen (e.g., S-59). Such photoactivating or photochemical pathogen-inactivating compounds described herein may include, but are not limited to, psoralens, isoaloxazines, alloxazines, phthalocyanines, phenothiazines, and porphyrins, and here these terms are understood to encompass a general class of compounds, namely, core compounds and their preferred derivatives. For example, psoralen(plural or singular) generally refers to psoralen core compounds and any derivatives thereof (e.g., amotosalen), and isoaloxazine(plural or singular) generally refers to isoaloxazine cores and any derivatives thereof (e.g., riboflavin). Such derivatives include the core compound structure and additional substituents on the core. Descriptions of such compounds include any salts thereof.
[0250] The term "amotosalen" means the compound 3-(2-aminoethoxymethyl)-2,5,9-trimethylfuro[3,2-g]chromen-7-one and any of its salts. This compound may also be referred to as 4'-(4-amino-2-oxa)butyl-4,5',8-trimethylpsoralen. When the method of the present disclosure involves adding amotosalen HCl (the HCl salt of amotosalen), removing this compound from biological fluids such as, by way of example, blood products (e.g., platelet compositions, units of platelets, plasma compositions, whole blood compositions, plasma compositions) is not limited to the removal of amotosalen HCl, since amotosalen can be present in solution as other salts or the free base. When used in the methods described herein, removal of amotosalen means removal of this compound in any form, e.g., the free base or as any salt, measured by the assays described herein.
[0251] In some embodiments, the pathogen inactivation compound is a 4-primary amino-substituted psoralen, which is a psoralen compound having an NH2 group linked to the 4'-position of psoralen by a hydrocarbon chain having a total length of 2 to 20 carbons, where 0 to 6 of these carbons are independently replaced by NH or O, and each point of replacement is at least 2 carbons away from the point of replacement of each other and at least 1 carbon away from psoralen. The 4'-primary amino-substituted psoralen may have additional substitutions at the 4-, 5', and 8-positions of psoralen, and such substitutions include, but are not limited to, the following groups: H and (CH2) n CH3, where n = 0 to 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) z- A 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), as well as b) H and (CH2) v The formula comprises substituents R5, R6, and R7 on the 4th, 5', and 8th carbon atoms, respectively, independently selected from the group containing CH3 or salts thereof (wherein v is an integer from 0 to 5).
[0252] In some embodiments, the pathogen inactivation compound is a 5-primary aminosubstituted psoralen, which is a psoralen compound having an NH2 group linked to the 5' position of the psoralen by a full-length hydrocarbon chain of 1 to 20 carbons, where 0 to 6 of these carbons are independently replaced by NH or O, and each substitution point is at least 2 carbons away from each other and at least 1 carbon from the psoralen. The 5'-primary aminosubstituted psoralen may have additional substitutions at the 4, 4', and 8 positions of the psoralen, which include, but are not limited to, the following groups: H and (CH2) n CH3, where n=0~6. In some embodiments, the 5'-primary aminosubstituted psoralene 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), as well as b) H and (CH2) vSubstituents R5, R6, and R7 on the 4th, 4', and 8th carbon atoms, respectively, independently selected from the group including CH3 or its salts (wherein v is an integer from 0 to 5, and R1 is -(CH2) u -When selected from the group including NH2, R7 is (CH2). v CH3, and R5, R6, and R7 are (CH 2 ) v (If it is CH3, u is an integer between 3 and 10). Exemplary psoralen compounds are described, for example, in U.S. Patent 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 being mixed with the biological fluid. Platelet additive solutions are known in the art, as described, for example, by 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)), and these are incorporated herein by reference in their entirety. In some embodiments, the platelet additive solution (PAS) comprises one or more of the following: chlorides, acetates, citrates, potassium, magnesium, phosphates, glucons, glucose, and bicarbonates. In some embodiments, the platelet additive solution (PAS) is a PAS approved by a regulatory authority or a generally accepted accreditation body in the art.
[0254] In some embodiments, the method further includes stirring the biological fluid. In some embodiments of any of the methods provided herein, the total dose of ultraviolet light irradiated onto the biological fluid (e.g., emitted by one or more light sources, emitted by a set of one or more light sources, emitted by a light source array) is about 0.5 J / cm². 2~about 50J / cm 2 For example, approximately 0.5 J / cm² 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 approximately 40 J / cm² 2 ~about 50J / cm 2 It is one of the following. In some embodiments, the total dose of ultraviolet light irradiated onto the biological fluid is approximately 0.5 J / cm². 2 For example, approximately 1 J / cm 2 More than 2J / cm 2 More than 3J / cm 2Above, 4 J / cm 2 Above, 5 J / cm 2 Above, 6 J / cm 2 Above, 7 J / cm 2 Above, 8 J / cm 2 Above, 9 J / cm 2 Above, 10 J / cm 2 Above, 15 J / cm 2 Above, 20 J / cm 2 Above, 25 J / cm 2 Above, 30 J / cm 2 Above, 35 J / cm 2 Above, 40 J / cm 2 Above, 45 J / cm 2 Above, or 50 J / cm 2 Among the above, any one of them. In some embodiments, the total dose of ultraviolet light irradiated on the biological fluid is about 50 J / cm 2 Less than, about 40 J / cm 2 Less than, about 30 J / cm 2 Less than, about 25 J / cm<…It should be understood that treatment of a biological fluid to inactivate potentially present pathogens(s) does not necessarily completely inactivate all potentially present pathogens, but rather substantially reduces the amount of pathogens to significantly reduce the risks arising from the presence of pathogens (e.g., infections associated with the administration of biological fluids contaminated with pathogens, transfusion-related diseases 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., viral particles, bacteria) in a given volume, and the level of inactivation is typically expressed as a logarithmic reduction of the pathogen's infectivity, i.e., a logarithmic reduction of its titer. Methods for assaying logarithmic reductions of titers and measuring them to assess the level of pathogen inactivation are well known in the art. In some embodiments, the systems, apparatus, and / or methods for treatment are sufficient to inactivate at least one logarithm (e.g., at least two logarithms, at least three logarithms, at least four logarithms, or more) of pathogens in the biological fluid when present. In some embodiments, the irradiated biological fluid is suitable for injection into a target without further processing to remove residual pathogen-inactivating compounds or their photoproducts. In some embodiments, the system, apparatus, and / or method for treatment is sufficient to inactivate at least one-to-one (e.g., at least two-to-one, at least three-to-one, at least four-to-one, or more) pathogens in the biological fluid when present, and the biological fluid contains 10 μM or less of pathogen-inactivating compounds after irradiation. In some embodiments, the system, apparatus, and / or method for treatment is sufficient to inactivate at least one-to-one (e.g., at least two-to-one, at least three-to-one, at least four-to-one, or more) pathogens in the biological fluid when present, and the biological fluid contains 7.5 μM or less of pathogen-inactivating compounds after irradiation.In some embodiments, the system, apparatus, and / or method for processing is sufficient to inactivate at least one-logarithmic (e.g., at least two-logarithmic, at least three-logarithmic, at least four-logarithmic, or more) 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 about 15 μM to 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 retains sufficient biological activity, and as a result, the biological fluid is suitable for injection into the target. In any of the embodiments described above, the biological fluid may be a blood product (e.g., platelets, plasma).
[0256] In some embodiments of the above-described 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 embodiments of the above-described apparatus, separating multiple non-safety-critical components from multiple safety-critical components involves configuring a domain-specific interface language to minimize the impact of changes to one or more non-safety-critical components on multiple safety-critical components.
[0258] In some embodiments of the above apparatus, the apparatus further includes one or more processing chambers configured to receive biological fluids, and each platform of one or more platforms is configured to be located within one of the processing chambers.
[0259] In some embodiments of the above apparatus, safety-critical components further include one or more agitators, each agitator configured to agitate at least one of one or more platforms.
[0260] In some embodiments of the above apparatus, safety-critical components further include one or more sensors configured to detect light energy from one or more optical devices.
[0261] In some embodiments of the above apparatus, one or more modular optical devices include one or more arrays of light sources arranged to irradiate a biological fluid, and the arrays of light sources are configured to emit light of the ultraviolet spectrum.
[0262] In some embodiments of the above apparatus, one or more light source arrays include multiple light sources, each of which emits light having a full-width half-maximum (FWHM) spectral bandwidth of less than 20 nanometers.
[0263] In some embodiments of the above apparatus, an array of one or more light sources includes multiple light sources, and each of the multiple light sources is a light-emitting diode (LED).
[0264] In some embodiments of the above apparatus, each of one or more arrays of light sources comprises a first light source channel configured to emit ultraviolet light having a first peak wavelength of the array.
[0265] In some embodiments of the above apparatus, each of one or more arrays of 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-power (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, one or more of which are light-emitting diodes (LEDs).
[0268] In some embodiments of the above apparatus, one or more optical devices further include one or more sensors configured to detect light energy from an array of one or more light sources.
[0269] In some embodiments of the above-described apparatus, one or more safety-critical components include computing hardware configured to execute one or more algorithms and to store information regarding the operation of the electronic device.
[0270] In some embodiments of the above-described apparatus, the second controller is configured to turn on or off one or more safety-critical components based on one or more operating conditions of the apparatus.
[0271] In some embodiments of the above-described device, one or more safety components are collectively configured to implement a hardware watchdog.
[0272] In some embodiments of the above-described device, one or more safety components are collectively configured to implement a software watchdog.
[0273] In some embodiments of the above-described apparatus, one or more non-safety-critical components include a display configured to provide information to the user of the apparatus and / or to receive input from the user of the apparatus.
[0274] In some embodiments of the above apparatus, it is used in a method for processing a biological fluid, the method comprising providing a biological fluid mixed with a pathogen inactivating compound, and irradiating the biological fluid with ultraviolet light having a first peak wavelength of about 315 nm to about 350 nm, emitted by 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 irradiation of the biological fluid occurs for a period and intensity sufficient to inactivate pathogens in the biological fluid.
[0275] In some embodiments of the above apparatus, the apparatus further includes a processing interface through which a first controller is communicatively coupled to a plurality of safety-critical components, and a second controller is communicatively coupled to a plurality of safety-critical components; one or more processors; memory; and one or more programs, which are stored in memory and configured to be executed by one or more processors, the one or more programs communicatively coupling the plurality of safety-critical components to the processing interface, and in response to the communicative coupling of the plurality of safety-critical components to the processing interface, the controller detects the presence of the plurality of safety-critical components and the plurality of safety-critical components, transmits a first message between the first controller and the safety-critical components via the processing interface, and transmits a second message between the second controller and the safety-critical components via the processing interface, the first message determines the state of the safety-critical components, and the second message determines the state of the safety-critical components.
[0276] In some embodiments of the above apparatus, a non-safety-critical component or a safety-critical component is in a first state, and one or more programs further include instructions for changing the state of the non-safety-critical component or the safety-critical component, and in response to the change in state, the non-safety-critical component or the safety-critical component sends a second message via a processing interface to a first controller or a second controller, the first controller or the second controller receives the second message, and in response to the receipt of the second message, determines a second state of the processing component.
[0277] In some embodiments of the above-described apparatus, one or more programs further include instructions for supplying power to an electronic device, and in response to the supply of 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-described apparatus, one or more programs further include instructions for assigning local network addresses and ports to a plurality of non-security-critical components and a plurality of security-critical components in response to the supply of power to the electronic device, wherein the local network addresses or ports are based on a domain-specific device interface language.
[0279] In some embodiments of the above-described device, one or more messages written in a domain-specific interface language can be transmitted using TCP / IP.
[0280] In another embodiment, a method for treating a biological fluid includes providing a biological fluid mixed with a photoactive pathogen inactivating compound, and irradiating the biological fluid with any of the above-described apparatus for a period and intensity sufficient to inactivate pathogens in the biological fluid.
[0281] In another embodiment, a method for operating an electronic device for processing a biological fluid, the electronic device comprising a controller, a non-safety-critical component, a safety-critical component, and a processing interface, the method comprising coupling the non-safety-critical component or the safety-critical component to the processing interface, the controller detecting the presence of the non-safety-critical component or the safety-critical component in the electronic device in response to the coupling of the non-safety-critical component or the safety-critical component to the processing interface, transmitting 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 the 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 a processing interface, safety-critical components are coupled to the processing interface, and the method includes coupling non-safety-critical components to the processing interface and separating the non-safety-critical components from the safety-critical components, the separation including configuring a domain-specific interface language to minimize the impact on the safety-critical components due to one or more changes to the non-safety-critical components.
[0283] In some aspects of the above method, a non-safety-critical or safety-critical component is in a first state, and the method further includes changing the state of the non-safety-critical or safety-critical component from the first state to a second state, sending a second message from the non-safety-critical or safety-critical component to the controller via a processing interface in response to the state change, 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 the platform, optical device, agitator, and safety components, and one or more safety components are configured to monitor the operation of the safety-critical component.
[0285] In some aspects of the above method, the method further includes isolating the processing interface from the external network using a domain-specific interface language.
[0286] In some aspects of the above method, the method further includes supplying power to an electronic device, and the presence of a processing component is further detected in response to the supply of power to the electronic device.
[0287] In some aspects of the above method, the method further includes assigning a local network address or port to a non-security-critical or security-critical component in response to the supply of power to an electronic device, the local network address or port being based on a domain-specific interface language.
[0288] In some aspects of the above method, one or more messages written in a domain-specific interface language can be sent using TCP / IP.
[0289] In another embodiment, an electronic device for processing biological fluids 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 being stored in memory and configured to be executed by one or more processors, the one or more programs comprising instructions to use the controller to detect the presence of a non-safety-critical component or a safety-critical component in the electronic device in response to the coupling of a non-safety-critical component or a safety-critical component to the processing interface, to send a message based on a domain-specific interface language to the processing interface between the controller and the non-safety-critical component or the safety-critical component via the processing interface, and to determine the state of the non-safety-critical component or the safety-critical component based on the message.
[0290] In another embodiment, a non-temporary computer-readable storage medium for storing one or more programs, the one or more programs comprising instructions, which, when executed by an electronic device comprising one or more processors and memory, cause the device to: connect non-essential or safety-critical components to a processing interface; in response to the connection of the non-essential or safety-critical components to the processing interface, use a controller to detect the presence of the non-essential or safety-critical components in the electronic device; transmit messages between the controller and the non-essential or safety-critical components via the processing interface based on a domain-specific interface language; and determine the state of the non-essential or safety-critical components 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 which is configured to carry one or more biological fluids; one or more optical devices, each optical device configured to irradiate the biological fluid; and one or more safety components configured to monitor the 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 and second controllers 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 several non-safety-critical components from several safety-critical components involves configuring a domain-specific interface language to minimize the impact of changes to one or more non-safety-critical components on several safety-critical components.
[0295] In some embodiments, the apparatus further includes one or more processing chambers configured to receive biological fluids, and each platform of one or more platforms is configured to be located within one of the processing chambers.
[0296] In some embodiments, safety-critical components further include one or more agitators, each agitator configured to agitate at least one of one or more platforms.
[0297] In some embodiments, safety-critical components further include one or more sensors configured to detect light energy from one or more modular optical devices.
[0298] In some embodiments, one or more modular optical devices include one or more arrays of light sources arranged to irradiate a biological fluid, and the arrays of light sources are configured to emit light from the ultraviolet spectrum.
[0299] In some embodiments, each of one or more arrays of 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.
[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, one or more of which are light-emitting diodes (LEDs).
[0302] In some embodiments, one or more optical devices further include one or more sensors configured to detect light energy from one or more arrays of light sources.
[0303] In some embodiments, one or more safety-critical components include computing hardware configured to execute one or more algorithms and to store information regarding the operation of the electronic device.
[0304] In some embodiments, the second controller is configured to turn on or off one or more safety-critical components based on one or more operating conditions of the device.
[0305] In some embodiments, one or more safety components are collectively configured to implement a hardware watchdog.
[0306] In some embodiments, one or more safety components are collectively configured to implement a software watchdog.
[0307] In some embodiments, one or more non-safety-critical components include a display configured to provide information to the user of the device and / or to receive input from the user of the device.
[0308] In some embodiments, the method is used to process a biological fluid, the method comprising providing a biological fluid mixed with a pathogen inactivating compound, and irradiating the biological fluid with ultraviolet light having a first peak wavelength of about 315 nm to about 350 nm, emitted by 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 irradiation of the biological fluid occurs for a period and intensity sufficient to inactivate pathogens in the biological fluid.
[0309] In some embodiments, the device 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; memory; and one or more programs, which are stored in memory and configured to be executed by one or more processors, the one or more programs communicatively coupling the plurality of non-safety-critical components to the processing interface, and in response to the communicative coupling of the plurality of safety-critical components to the processing interface, the controllers detect the presence of the plurality of non-safety-critical components and the plurality of safety-critical components, transmit a first message between the first controller and the non-safety-critical components via the processing interface, and transmit a second message between the second controller and the safety-critical components via the processing interface, the first message being used to determine the state of the non-safety-critical components and the second message being used to determine the state of the safety-critical components.
[0310] In some embodiments, a non-safety-critical or safety-critical component is in a first state, and one or more programs further include instructions for changing the state of the non-safety-critical or safety-critical component from the first state to a second state, and in response to the state change, the non-safety-critical or safety-critical component sends a second message via a processing interface to a first controller or a second controller, the first controller or the second controller receives the second message, and in response to the receipt of the second message, determines a second state of the processing component.
[0311] In some embodiments, one or more programs further include instructions for supplying power to an electronic device, and in response to the power supply to the electronic device, the presence of several non-safety-critical components and several safety-critical components is further detected.
[0312] In some embodiments, one or more programs further include instructions for assigning local network addresses and ports to a plurality of non-security-critical components and a plurality of security-critical components in response to the supply of power to an 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 can be sent using TCP / IP.
[0314] In some embodiments, a method for 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 above-described apparatus for a period and intensity sufficient to inactivate the pathogens in the biological fluid.
[0315] In some embodiments, a method for operating an electronic device for processing biological fluids, the electronic device comprising a controller, a non-safety-critical component, a safety-critical component, and a processing interface, the method comprising: coupling the non-safety-critical component or the safety-critical component to the processing interface; the controller detecting the presence of the non-safety-critical component or the safety-critical component in the electronic device in response to the coupling of the non-safety-critical component or the safety-critical component to the processing interface; transmitting 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 the 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 a processing interface, safety-critical components are coupled to the processing interface, and the method includes coupling non-safety-critical components to the processing interface and separating the non-safety-critical components from the safety-critical components, the separation including configuring a domain-specific interface language to minimize the impact on the safety-critical components due to one or more changes to the non-safety-critical components.
[0317] In some embodiments, a non-safety-critical or safety-critical component is in a first state, and the method further includes changing the state of the non-safety-critical or safety-critical component from the first state to a second state, sending a second message from the non-safety-critical or safety-critical component to the controller via a processing interface in response to the state change, 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, safety-critical components are one of the following: a platform, a modular optical device, a stirrer, and a safety component, and one or more safety components are configured to monitor the operation of the safety-critical components.
[0319] In some embodiments, the method further includes isolating the processing interface from the external network using a domain-specific interface language.
[0320] In some embodiments, the method further includes supplying power to an electronic device, and the presence of a processing component is further detected in response to the power supply to the electronic device.
[0321] In some embodiments, the method further includes assigning a local network address or port to a non-security-critical or security-critical component in response to the supply of power to an electronic device, the local network address or port being based on a domain-specific interface language.
[0322] In some embodiments, one or more messages written in a domain-specific interface language can be sent using TCP / IP.
[0323] In some embodiments, an electronic device for processing biological fluids 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, wherein one or more programs are stored in memory and configured to be executed by one or more processors, and the one or more programs include instructions to use the controller to detect the presence of a non-safety-critical component or a safety-critical component in the electronic device in response to coupling of a non-safety-critical component or a safety-critical component to the processing interface, to send a message based on a domain-specific interface language to the processing interface via the processing interface between the controller and the non-safety-critical component or the safety-critical component, and to determine the state of the non-safety-critical component or the safety-critical component based on the message.
[0324] In some embodiments, a non-temporary computer-readable storage medium storing one or more programs, the one or more programs comprising instructions, which, when executed by an electronic device having one or more processors and memory, cause the device to: connect non-essential or safety-critical components to a processing interface; in response to the connection of the non-essential or safety-critical components to the processing interface, use a controller to detect the presence of the non-essential or safety-critical components in the electronic device; transmit messages between the controller and the non-essential or safety-critical components via the processing interface based on a domain-specific interface language; and determine the state of the non-essential or safety-critical components based on the messages.
[0325] Variations of the embodiments provided herein may be apparent to those skilled in the art by reading the foregoing description. Those skilled in the art will expect to be able to use such variations, as well as other embodiments of the compositions, methods, and kits described herein that are not specifically described herein. Accordingly, the systems and methods described herein include all modifications and equivalents of the subject matter enumerated in the appended claims, as permitted by applicable law. Furthermore, any combination of the above elements in all possible variations thereof is incorporated herein unless otherwise shown herein or is clearly inconsistent with the context. The following is a list of specific embodiments of this disclosure. This list is illustrative and not intended to limit the disclosure provided herein.
[0326] Embodiment 1: A modular optical device for use in combination with an electronic device for processing biological fluids, wherein the modular optical device comprises a plurality of components collectively configured to transmit light through one or more biological fluids for processing, and the modular optical device is A housing configured to accommodate one or more components of the modular optical device, A light source array chamber configured to transmit light, wherein the light source array chamber is One or more light source arrays, each including multiple light sources configured to generate UV light, The light source array chamber includes 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 one or more biological fluids for processing, The modular optical device comprises a driver that is communicatively coupled to one or more components of the modular optical device and configured to operate the one or more components.
[0327] Embodiment 2: The modular optical apparatus according to Embodiment 1, wherein the light source array chamber comprises one or more temperature sensors configured to measure temperature.
[0328] Embodiment 3: A modular optical apparatus according to Embodiment 1 or Embodiment 2, wherein each 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: A modular optical device according to any one of Embodiments 1 to 3, wherein each of the plurality of light sources is a light-emitting diode (LED).
[0330] Embodiment 5: A modular optical device according to any one of Embodiments 1 to 4, wherein each of the one or more light source arrays comprises a first light source channel configured to emit ultraviolet light having a first peak wavelength of the array.
[0331] Embodiment 6: A modular optical apparatus according to 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: The modular optical device according to any one of Embodiments 1 to 6, wherein the modular optical device is configured to be placed inside the electronic device in order to transmit light to one or more biological fluids in the processing chamber of the electronic device.
[0333] Embodiment 8: A modular optical device according to 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 optical device when it is placed inside the electronic device.
[0334] Embodiment 9: The modular optical device according to Embodiment 8, wherein one or more tracks are configured to allow the modular optical device to slide in order to remove the modular optical device and insert it into an electronic device.
[0335] Embodiment 10: A modular optical device according to any one of Embodiments 1 to 9, wherein the modular optical device comprises one or more heat exchangers configured to dissipate heat from the light source array and / or the modular optical device.
[0336] Embodiment 11: The modular optical device according to Embodiment 10, wherein 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 optical device.
[0337] Embodiment 12: A modular optical device according to 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: The modular optical device according to any one of Embodiments 1 to 12, wherein the window portion comprises a window material that covers or surrounds the opening of the modular optical device, and the window material is made of glass.
[0339] Embodiment 14: The modular optical device according to any one of Embodiments 1 to 12, wherein the window portion comprises a window material that covers or surrounds the opening of the modular optical device, and the window material is made of a polymer material.
[0340] Embodiment 15: The modular optical device according to 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: The modular optical device according to any one of Embodiments 1 to 15, wherein the modular optical device comprises one or more optical sensors arranged on one or more light source arrays.
[0342] Embodiment 17: The modular optical device according to any one of Embodiments 1 to 16, wherein the modular optical device comprises one or more optical sensors arranged in the window portion and configured to detect light generated by the modular optical device.
[0343] Embodiment 18: The modular optical device according to any one of Embodiments 1 to 17, wherein the modular optical device comprises one or more circuits arranged in the window portion, and the one or more circuits comprises one or more light sensors arranged in the circuit and configured to detect light generated by the modular lighting device.
[0344] Embodiment 19: A modular optical apparatus according to 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: The modular optical apparatus according to Embodiment 19, wherein the plurality of reflector panels are arranged within the light source array chamber to minimize the loss of light energy around the light source array chamber.
[0346] Embodiment 21: The modular optical device according to any one of Embodiments 1 to 20, wherein one or more of the light sensors in the light source array chamber are oriented to detect light generated by a separate modular optical device.
[0347] Embodiment 22: A modular optical device according to any one of Embodiments 1 to 21, wherein one or more optical sensors are mounted using photodiodes.
[0348] Embodiment 23: A modular optical device according to any one of Embodiments 1 to 22, wherein one or more temperature sensors are implemented using thermistors.
[0349] Embodiment 24: A modular optical device according to any one of Embodiments 1 to 23, wherein one or more of the one or more temperature sensors are configured to measure temperature at the junction between one of the one or more light sources and a printed circuit board (PCB) on which the light source is arranged.
[0350] Embodiment 25: A modular optical device according to any one of Embodiments 1 to 24, wherein the plurality of light sources are configured to generate UV-A light.
[0351] Embodiment 26: The modular optical apparatus according to Embodiment 25, wherein the plurality of light sources are configured to generate light having a first peak wavelength of approximately 315 nm to approximately 350 nm.
[0352] Embodiment 27: A modular optical device according to any one of Embodiments 1 to 24, wherein the plurality of light sources are configured to generate UV-B or UV-C light.
[0353] Embodiment 28: A modular optical apparatus according to any one of Embodiments 5 to 27, wherein each of the arrays of one or more light sources includes a second light source channel configured to emit ultraviolet light having a second peak wavelength of the array, the second peak wavelength being at least 5 nanometers different from the first peak wavelength.
[0354] Embodiment 29: The modular optical apparatus according to Embodiment 28, wherein each array of one or more light sources comprises a first light source channel configured to emit ultraviolet light having a first peak wavelength of the array in the UV-A spectrum, and a 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: The modular optical device according to any one of Embodiments 1 to 29, wherein the housing comprises one or more electronic interfaces configured to communicatively couple the modular optical device to the electronic device.
[0356] Embodiment 31: The modular optical device according to Embodiment 30, wherein the one or more electronic interfaces include an interlock connection configured to allow the electronic device to turn off the modular optical device.
[0357] Embodiment 32: The modular optical device according to Embodiment 30, wherein the one or more electronic interfaces are communication ports, the communication ports being configured to allow the electronic device to send commands to the modular optical device and the modular optical device to send data to the electronic device.
[0358] Embodiment 33: The modular optical device according to Embodiment 30, wherein the one or more electronic interfaces include a power port configured to transmit power from the electronic device to the modular optical device.
[0359] Embodiment 34: A modular optical apparatus according to any one of Embodiments 1 to 33, wherein some light sources in the light source array chamber are configured to provide a predetermined amount of light to one or more biological fluids.
[0360] Embodiment 35: A modular optical apparatus according to any one of Embodiments 1 to 34, wherein one or more light sources in 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: The modular optical device according to Embodiment 35, wherein the variation in the irradiance of the light across the surface of the biological fluid is less than 25%.
[0362] Embodiment 37: A modular optical device according to any one of Embodiments 1 to 36, wherein one or more light sources in the light source array chamber are LEDs configured to have a beam angle of about 110 degrees to about 130 degrees.
[0363] Embodiment 38: A modular optical device according to any one of Embodiments 1 to 37, wherein the dose irradiated onto a biological fluid from the modular optical device during a processing process is based on light detected by one or more of the one or more optical sensors.
[0364] Embodiment 39: A modular optical device according to any one of Embodiments 1 to 38, wherein the amount of time the modular optical device is activated during the processing process is based on light detected by one or more of the one or more optical sensors.
[0365] Embodiment 40: A modular optical device according to any one of Embodiments 1 to 39, wherein the intensity of light generated by the modular optical device during a processing step is based on light detected by one or more of the one or more optical sensors.
[0366] Embodiment 41: A modular optical device according to 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 the biological sample with light for processing.
[0367] Embodiment 42: A modular optical device according to any one of Embodiments 1 to 41, wherein the electronic device for processing a biological fluid comprises a first modular optical device and a second modular optical device, the first and second modular optical devices are oriented to face each other, and the first and second modular optical devices collectively irradiate the biological fluid with light for processing.
[0368] Embodiment 43: The first and second optical devices are configured to perform a test, and the test is performed Transmitting light from the aforementioned first modular optical device, One or more optical sensors of the second modular optical device detect the light transmitted from the first device, and The modular optical device according to Embodiment 42, further comprising determining the presence or absence of one or more occlusions to the light transmitted by the first modular optical device by comparing the detected light with a predetermined amount of light.
[0369] Embodiment 44: The above test, Transmitting light from the aforementioned second modular optical device, One or more optical sensors of the first modular optical device detect the light transmitted from the second modular optical device, and The modular optical device according to Embodiment 43, further comprising determining the presence or absence of one or more occlusions to the light transmitted by the second modular optical device by comparing the detected light with a predetermined light level.
[0370] Embodiment 45: The modular optical device according to Embodiment 43 or 44, wherein the test further includes the step of determining a baseline amount of light transmitted from the first modular optical device to the second modular optical device.
[0371] Embodiment 46: A modular optical device according to any one of Embodiments 43 to 45, wherein the test is a test for determining the presence of an obstructed optical path within the electronic device.
[0372] Embodiment 47: A modular optical apparatus according to any one of Embodiments 43 to 45, wherein the test is a test for determining the presence of a biological fluid to be processed within the electronic device.
[0373] Embodiment 48: The modular optical device is configured to perform a test, and the test is, Transmitting light from one or more light source arrays in the light source array chamber of the modular optical device, The modular optical device according to any one of embodiments 17 to 47, further comprising detecting the light transmitted by the one or more light source arrays using one or more optical sensors of the modular optical device.
[0374] Embodiment 49: The modular optical device according to Embodiment 48, wherein the one or more optical sensors are optical sensors arranged in the window portion of the modular optical device.
[0375] Embodiment 50: The modular optical apparatus according to Embodiment 48 or Embodiment 49, wherein the test further comprises comparing the detected light with a predetermined light intensity.
[0376] Embodiment 51: The above test is a) Determining the integrity of one or more of the one or more sensors, b) Determining the integrity of one or more light sources of the one or more light source arrays, the modular optical device according to any one of embodiments 48 to 50, comprising either or both of the above.
[0377] Embodiment 52: The modular optical device is configured to perform a calibration process, the process being: Transmitting light from one or more light source arrays of the modular optical device, Receiving data from a calibration device located within the electronic device, wherein the calibration device is configured to detect the light transmitted by the light source array(s) of the modular optical device using one or more optical sensors of the calibration device. The received data is compared with a predetermined amount of light, and A modular optical device according to 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 described above.
[0378] Embodiment 53: A method for processing biological fluids, To provide the aforementioned biological fluid, and The method comprising irradiating the biological fluid with one or more modular optical 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 for processing biological fluids, To provide the biological fluid mixed with a pathogen inactivating compound, The method comprising irradiating the biological fluid with one or more modular optical 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 preceding descriptions have been written for illustrative purposes with reference to specific embodiments. However, the above exemplary considerations are not intended to be exhaustive, nor are they intended to limit this disclosure to the exact form disclosed. Many modifications and variations are possible in light of the above teachings. The embodiments have been selected and described to best illustrate the principles of the techniques and their practical applications. Thereafter, those skilled in the art will be able to make optimal use of the art and its various embodiments with various modifications suitable for the specific use intended.
[0381] While 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. Such changes and modifications should be understood to fall within the scope of the disclosure and examples as defined by the claims.
Claims
1. A modular optical device configured to be placed within an electronic device for processing biological fluids, wherein the modular optical device comprises a plurality of components collectively configured to transmit light through one or more biological fluids for processing, The aforementioned modular optical device, A housing configured to accommodate one or more components of the modular optical device, A light source array chamber configured to transmit light, wherein the light source array chamber is One or more light source arrays, each of which comprises a plurality of light sources configured to generate UV light, One or more light sensors configured to detect light and A light source array chamber comprising, A window portion configured to pass UV light generated by the plurality of light sources through one or more biological fluids for processing, wherein the window portion comprises a window material that covers or surrounds the opening of the modular optical device, A driver that is communicatively coupled to one or more components of the modular optical device, wherein the driver is configured to operate the one or more components, and A modular optical device equipped with the following features.
2. The modular optical apparatus according to claim 1, wherein the light source array chamber comprises one or more temperature sensors configured to measure temperature.
3. The modular optical apparatus according to claim 1 or claim 2, wherein each of the plurality of light sources emits light having a full width at half maximum (FWHM) spectral bandwidth of less than 20 nanometers.
4. The modular optical device according to any one of claims 1 to 3, wherein each of the plurality of light sources is a light-emitting diode (LED).
5. The modular optical apparatus according to any one of claims 1 to 4, wherein each of the one or more light source arrays comprises a first light source channel configured to emit ultraviolet light having a first peak wavelength of the array.
6. The modular optical device according to any one of claims 1 to 5, wherein the modular optical device is configured to be placed within the electronic device to transmit light to one or more biological fluids in a processing chamber of the electronic device, and the processing chamber is configured to receive at least one of the one or more biological fluids.
7. The modular optical device according to any one of claims 1 to 6, 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 optical device when the modular optical device is placed inside the electronic device.
8. The modular optical device according to claim 7, wherein one or more tracks are configured to allow the modular optical device to slide in order to remove the modular optical device and insert the modular optical device into the electronic device.
9. The modular optical device according to any one of claims 1 to 8, wherein the modular optical device comprises one or more heat exchangers configured to dissipate heat from the light source array and / or the modular optical device.
10. The modular optical device according to claim 9, wherein the one or more heat exchangers are configured to transfer heat from the light source array and / or the modular optical device by exchanging heat with air passing through the one or more heat exchangers.
11. The modular optical device according to any one of claims 9 to 10, 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.
12. The modular optical device according to any one of claims 1 to 9, wherein the modular optical device comprises one or more fans.
13. The modular optical device according to claim 1, wherein the window material is made of glass.
14. The modular optical device according to claim 1, wherein the window material is made of a polymer material.
15. The modular optical apparatus according to any one of claims 1 to 14, wherein the window portion is at least 80% transparent to UV light of a selected wavelength.
16. The modular optical device according to any one of claims 1 to 15, wherein the modular optical device comprises one or more optical sensors arranged on the one or more light source arrays.
17. The modular optical device according to any one of claims 1 to 16, wherein the modular optical device comprises one or more optical sensors arranged in the window portion, and the one or more optical sensors are configured to detect light generated by the modular optical device.
18. The modular optical device according to any one of claims 1 to 17, wherein the modular optical device comprises one or more circuits arranged in the window portion, the one or more circuits comprises one or more optical sensors arranged in the circuit, and the one or more optical sensors are configured to detect light generated by the modular optical device.
19. The modular optical device according to claim 18, wherein each of the one or more circuits has a width of 5 mm or less, 4 mm or less, or 3 mm or less.
20. The modular optical apparatus according to any one of claims 1 to 19, wherein the light source array chamber includes a plurality of reflector panels arranged along one or more edges of the light source array chamber.
21. The modular optical apparatus according to claim 20, wherein the plurality of reflector panels are arranged within the light source array chamber to minimize the loss of light energy around the light source array chamber.
22. The modular optical device according to any one of claims 1 to 21, wherein one or more optical sensors in the light source array chamber are oriented to detect light generated by a separate modular optical device.
23. The modular optical device according to any one of claims 1 to 22, wherein the one or more optical sensors are mounted using photodiodes.
24. The modular optical device according to claim 2, wherein the one or more temperature sensors are implemented using thermistors.
25. The modular optical device according to claim 2, wherein one or more of the one or more temperature sensors are configured to measure temperature at the junction between one of the one or more light sources and a printed circuit board (PCB), and the one light source is arranged on the printed circuit board (PCB).
26. The modular optical apparatus according to any one of claims 1 to 25, wherein the plurality of light sources are configured to generate UV-A light.
27. The modular optical apparatus according to claim 26, wherein the plurality of light sources are configured to generate light having a first peak wavelength of about 315 nm to about 350 nm.
28. The modular optical apparatus according to any one of claims 1 to 25, wherein the plurality of light sources are configured to generate UV-B light or UV-C light.
29. The modular optical apparatus according to any one of claims 5 to 28, wherein each of the arrays of one or more light sources comprises a second light source channel configured to emit ultraviolet light having a second peak wavelength of the array, the second peak wavelength being at least 5 nanometers different from the first peak wavelength.
30. The modular optical apparatus according to claim 29, wherein each of the arrays of one or more light sources comprises a first light source channel configured to emit ultraviolet light having a first peak wavelength of the array in the UV-A spectrum, and a second light source channel configured to emit ultraviolet light having a second peak wavelength of the array in the UV-B spectrum or the UV-C spectrum.
31. The modular optical apparatus according to claim 29, wherein each of the arrays of one or more light sources comprises a first light source channel configured to emit ultraviolet light having a first peak wavelength of the array in the UV-A spectrum, and a second light source channel configured to emit ultraviolet light having a second peak wavelength of the array in the UV-A spectrum.
32. The modular optical device according to any one of claims 1 to 31, wherein the housing comprises one or more electronic interfaces configured to communicately couple the modular optical device to the electronic device.
33. The modular optical device according to claim 32, wherein the one or more electronic interfaces include an interlock connection configured to allow the electronic device to turn off the modular optical device.
34. The modular optical device according to claim 32 or 33, wherein the one or more electronic interfaces include a communication port, the communication port is configured to enable the electronic device to transmit commands to the modular optical device, and the modular optical device is configured to enable the electronic device to transmit data.
35. The modular optical device according to any one of claims 32 to 34, wherein the one or more electronic interfaces include a power port configured to transmit power from the electronic device to the modular optical device.
36. The modular optical apparatus according to any one of claims 1 to 35, wherein some of the light sources in the light source array chamber are configured to provide a predetermined amount of light to one or more biological fluids.
37. The modular optical apparatus according to any one of claims 1 to 36, wherein the one or more light sources in the light source array chamber collectively generate the light such that the irradiance of the light is substantially uniform on the surface of the biological fluid.
38. The modular optical device according to claim 37, wherein the variation in the irradiance of the light across the surface of the biological fluid is less than 25%.
39. The modular optical device according to any one of claims 1 to 38, wherein one or more light sources in the light source array chamber are LEDs configured to have a beam angle of about 110 degrees to about 130 degrees.
40. The modular optical device according to any one of claims 1 to 39, wherein the dose of light irradiated onto the biological fluid from the modular optical device during the processing process is based on light detected by one or more of the one or more photosensors.
41. The modular optical device according to any one of claims 1 to 40, wherein the amount of time the modular optical device is activated during the processing process is based on light detected by one or more of the one or more optical sensors.
42. The modular optical device according to any one of claims 1 to 41, wherein the intensity of light generated by the modular optical device during the processing process is based on light detected by one or more of the one or more optical sensors.
43. The modular optical device according to any one of claims 1 to 42, wherein the modular optical device is configured to be placed within the electronic device as a first modular optical device oriented to face the biological fluid to be processed, and the first modular optical device irradiates the biological fluid with light for processing.
44. The modular optical device according to claim 43, wherein the modular optical device is further configured to operate in conjunction with a second modular optical device located within the electronic device, the first modular optical device and the second modular optical device are oriented to face each other, and the first modular optical device and the second modular optical device collectively irradiate a biological fluid with light for processing.
45. The first modular optical device and the second modular optical device are configured to perform tests. The aforementioned test is, Transmitting light from the first modular optical device, One or more optical sensors of the second modular optical device detect the light transmitted by the first modular optical device, By comparing the detected light with a predetermined light intensity, the presence or absence of one or more occlusions in the light transmitted by the first modular optical device is determined. A modular optical device according to claim 44, including the above.
46. The aforementioned test is, Transmitting light from the second modular optical device, One or more optical sensors of the first modular optical device detect the light transmitted by the second modular optical device, By comparing the detected light with a predetermined light level, the presence or absence of one or more occlusions in the light transmitted by the second modular optical device is determined. The modular optical device according to claim 45, further comprising:
47. The modular optical device according to claim 45 or claim 46, further comprising determining a baseline amount of light transmitted to the second modular optical device by the first modular optical device.
48. The modular optical device according to any one of claims 45 to 47, wherein the test is a test for determining the presence of an obstructed optical path within the electronic device, and optionally a test for determining the presence of an obstructed optical path on the platform or tray of the electronic device.
49. The modular optical device according to any one of claims 45 to 48, wherein the test is for determining the presence of an obstructed optical path within the window portion of the first modular optical device or the second modular optical device.
50. The modular optical apparatus according to any one of claims 45 to 49, wherein the test is a test for determining the presence of a biological fluid to be processed in the electronic device.
51. The aforementioned modular optical device is configured to perform tests, The aforementioned test is, Transmitting light from one or more light source arrays in the light source array chamber of the modular optical device, One or more optical sensors in the modular optical device detect the light transmitted by the one or more light source arrays. A modular optical device according to any one of claims 1 to 50, including the above.
52. The modular optical device according to claim 51, wherein the one or more optical sensors are optical sensors arranged in the window portion of the modular optical device.
53. The modular optical apparatus according to claim 51 or 52, wherein the test further comprises comparing the detected light with a predetermined amount of light.
54. The aforementioned test is, Determining the integrity of one or more of the aforementioned sensors, and Determining the integrity of one or more light sources in the one or more light source arrays. A modular optical device according to any one of claims 51 to 53, further comprising one or both of the above.
55. The modular optical device is configured to perform a calibration process, The calibration process described above is: Transmitting light from one or more light source arrays of the modular optical device, Receiving data from a calibration device, wherein the calibration device is configured to detect the light transmitted by the one or more light source arrays of the modular optical device using one or more optical sensors of the calibration device, and the calibration device is located within the electronic device. The received data is compared with a predetermined amount of light, Based on the above comparison, the intensity of one or more light sources in the one or more light source array is adjusted. A modular optical device according to any one of claims 1 to 54, including the above.
56. A method for processing biological fluids, wherein the method is To provide the aforementioned biological fluid, Using one or more modular optical devices described in any one of claims 1 to 55, the biological fluid is illuminated for a period and intensity sufficient to inactivate pathogens in the biological fluid. Methods that include...
57. A method for processing biological fluids, wherein the method is To provide the biological fluid mixed with a pathogen inactivating compound, Using one or more modular optical devices described in any one of claims 1 to 55, the biological fluid is illuminated for a period and intensity sufficient to inactivate pathogens in the biological fluid. Methods that include...
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