System and method for determining red blood cell and buffy coat platelet quality based on plasma characterization

Abstract

A blood processing and / or manufacturing system includes a processing device and a fluid flow circuit selectively arranged on the processing device. The processing device is configured to interact with the fluid flow circuit to perform one or more blood separation procedures in which plasma is separated from whole blood. The system further includes an optical grading system arranged relative to a vessel of the fluid flow circuit containing the separated plasma, wherein the optical grading system is configured to determine a main wavelength of the plasma in the vessel and determine a red blood cell grade and / or a buffy coat platelet grade based on the main wavelength of the plasma.

Description

SYSTEM AND METHOD FOR DETERMINING RED BLOOD CELL AND BUFFY COAT PLATELET QUALITY BASED ON PLASMA CHARACTERIZATIONThe present application claims the benefit of and priority to U.S.Provisional Application 63 / 656,516, filed June 5, 2024, which is hereby incorporated herein by reference.Field of the Disclosure

[0001] The present disclosure relates to systems and methods for determining red blood cell and / or buffy coat platelet quality. More particularly, the present disclosure relates to systems and methods for automatically determining the red blood cell and / or buffy coat platelet quality based on color characteristics of plasma separated from whole blood during a blood processing procedure.Description of Related Art

[0002] Whole blood may be separated into its constituents (e.g., red cells, buffy coat ( / .e., white blood cells and platelets), and plasma) through centrifugation, such as in the AMICUS® separator from Fenwal, Inc. of Lake Zurich, III., which is an affiliate of Fresenius Kabi AG of Bad Homburg, Germany, or other centrifugal separation devices, or a spinning membrane-type separator, such as the AUTOPHERESIS-C® and AURORA® devices from Fenwal, Inc.

[0003] In a whole blood manufacturing setting, plasma is graded based on its visual appearance. The plasma grade then determines how the plasma will be used, i.e., for fractionation, transfusion, cryoprecipitate, or disposal. Common grades for plasma include, but are not limited to, clear yellow plasma, red-tinted clear plasma, yellow lipemic plasma, red-tinted lipemic plasma and green plasma.

[0004] In current practice, plasma units are graded manually by comparing the visual plasma color of collected plasma to a pre-established color grading system, often provided in printed form, e.g., on a poster or card at the grading station, after the blood processing procedure is complete. However, such a grading process is labor and resource intensive, and may be subject to inconsistent or subjective grading.

[0005] In addition, the plasma is graded at a time after the red blood cells and buffy coat platelets have been moved out of the manufacturing process. Thus, the visualappearance of the plasma is not used to determine the quality of red blood cells, buffy coat or platelets associated with the plasma.

[0006] Some blood processing systems may include an optical device for monitoring the composition of the blood or a component of the blood. A common approach to non-invasive blood and blood constituent analysis is based on the amount of light transmitted through the fluid. For example, U.S. Patent No. 10,893,829 (which is incorporated herein by reference) describes an optical system and method for measuring free hemoglobin, i.e., for quantifying free hemoglobin levels. While such a quantitative analysis may produce reliable results with respect to measuring free hemoglobin, it would be desirable to provide systems and methods for determining the quality of red blood cells and platelets with buffy coats.Summary

[0007] There are several aspects of the present subject matter which may be embodied separately or together in the devices and systems described and claimed below. These aspects may be employed alone or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to preclude the use of these aspects separately or the claiming of such aspects separately or in different combinations as set forth in the claims appended hereto.

[0008] In one aspect, a method for grading red blood cells and / or buffy coat platelets includes emitting, from a broadband light source, light having wavelengths in a visible range, directing the emitted light to a vessel at an incidence angle, and receiving, at an optical spectrometer, a reflected light portion of the emitted light. The method further includes analyzing, with the optical spectrometer, at least a portion of the received reflected light to determine a main wavelength of the received reflected light, and determining, with a controller, the red blood cell grade and / or the buffy coat platelet grade using the main wavelength. The main wavelength is the main wavelength of plasma within the vessel.

[0009] In another aspect, a method for grading red blood cells and / buffy coat platelets during a blood processing procedure includes providing whole blood to aseparation chamber of a fluid flow circuit, operating a centrifuge of a processing device to separate the whole blood into plasma and red blood cells in the separation chamber, providing the plasma in a first vessel of the fluid flow circuit fluidically connected to the separation chamber, determining, by an optical grading system, a main wavelength of the plasma in the first vessel, and determining, by the optical grading system, a red blood cell grade and / or a buffy coat platelet grade based on the main wavelength of the plasma.

[0010] In still another aspect, a blood processing and / or manufacturing system, includes a processing device having pump system, a valve system, a centrifuge and a nesting module, a fluid flow circuit having a plurality of fluid containers, a flow control cassette, and a separation chamber interconnected with one another with a plurality of fluid vessels. The flow control cassette is removably connected to the processing device at the nesting module and interfaces with one or more pumps of the pump system and one or more valves of the valve system. The separation chamber is received in the centrifuge, and the processing device is selectively operable to interact with the fluid flow circuit to perform a blood separation procedure having one or more stages in which the centrifuge is operated to separate whole blood into plasma and red blood cells in the separation chamber and the plasma exits the separation chamber into a first vessel of the plurality of fluid vessels, an optical grading system having a broadband light source, an optical spectrometer and a controller, wherein the optical grading system is arranged relative to the first vessel and configured to: determine a main wavelength of the plasma in the first vessel, determine a red blood cell grade and / or a buffy coat platelet grade based on the main wavelength of the plasma.

[0011] In yet another aspect, a blood processing and / or manufacturing system includes: a processing device and a fluid flow circuit selectively arranged on the processing device. The processing device is configured to interact with the fluid flow circuit to perform one or more blood separation procedures in which plasma is separated from whole blood. An optical grading system is arranged relative to a vessel of the fluid flow circuit configured to contain the separated plasma, wherein the optical grading system is configured to determine a main wavelength of the plasma in the firstvessel and determine a red blood cell grade and / or a buffy coat platelet grade based on the main wavelength of the plasma.

[0012] These and other aspects of the present subject matter are set forth in the following detailed description of the accompanying drawings.Brief Description of the Drawings

[0013] FIG. 1 is a diagram of an optical grading system according to examples of the present disclosure;

[0014] FIG. 2 is a partial diagram of the optical grading system of FIG. 1 further showing emitted light entering a vessel;

[0015] FIG. 3 is an end-view diagram showing an optical fiber bundle according to examples of the present disclosure;

[0016] FIG. 4 is a partial diagram of the optical grading system of FIG. 1 further showing light reflected by the plasma;

[0017] FIG. 5 is a chart showing an example of an optical spectrum produced by an optical spectrometer for determining a main wavelength of light reflected by the plasma;

[0018] FIG. 6 is a block diagram of a controller of the optical grading system of FIG. 1 according to examples of the present disclosure;

[0019] FIG. 7 is a block diagram of a memory of the controller of FIG. 6 according to examples of the present disclosure;

[0020] FIG. 8 is a table showing associations between wavelength information and grade information stored in the memory of FIGS. 6 and 7, according to examples of the present disclosure;

[0021] FIG. 9 is a block diagram showing an example method for determining a red blood cell grade and / or a buffy coat platelet grade according to the present disclosure;

[0022] FIG. 10 is a block diagram showing an example of another method for determining a red blood cell grade and / or a buffy coat platelet grade according to the present disclosure;

[0023] FIG. 1 1 illustrates an example of a processing device of a blood processing and / or manufacturing system configured for use with the optical grading system of FIG. 1 ;

[0024] FIG. 12 illustrates an example of a fluid flow circuit of a blood processing and / or manufacturing system configured for use with the optical grading system of FIG.1 and the processing device of FIG. 1 1 ;

[0025] FIGS. 13a-13c are schematic diagrams of fluid flow paths through the fluid flow circuit and blood processing and / or manufacturing system of FIGS. 11 and 12 in selected stages of a blood separation and collection procedure;

[0026] FIG. 14 is a diagram showing an example of the optical grading system of FIG. 1 arranged with respect to a flow control cassette of the fluid flow circuit of FIG. 12; and

[0027] FIG. 15 is a diagram showing an example of the optical grading system of FIG. 1 arranged with respect to a fluid container of the fluid flow circuit of FIG. 12.Description of the Illustrated Embodiments

[0028] The embodiments disclosed herein are for the purpose of providing a description of the present subject matter, and it is understood that the subject matter may be embodied in various other forms and combinations not shown in detail.Therefore, specific designs and features disclosed herein are not to be interpreted as limiting the subject matter as defined in the accompanying claims.

[0029] An optical grading system 10 according to various examples described herein is configured to determine a quality ( / .e., grade) of red blood cells and / or buffy coat platelets based, at least in part, on a measured dominant or main wavelength of light associated with plasma during a separation process of a blood manufacturing procedure. The terms “dominant wavelength” and “main wavelength” may be used interchangeably in the following description and present examples.

[0030] In addition, the terms “quality” and “grade” may be used interchangeably in the following description and present examples and may generally refer to an output which may indicate to the user a relative condition of the red blood cells and / or buffy coat platelets. The quality or grade may be presented to the user in a variety of formatsand may include varying levels of information. In some examples, the quality or grade may be provided as a number, letter, symbol or similar suitable indicia selected from a known scale of numbers, letters and symbols or similar suitable indicia, a qualitative description of the red blood cells and / or buffy coat platelets including conditions which may be determined by the present optical grading system, and / or a recommendation regarding suitable and / or unsuitable uses (e.g., as a particular blood product), or next processing step(s) for the red blood cells and / or buffy coat platelets. The quality or grade may be provided in various formats including, but not limited to, a letter, number, symbol, graphic, image, pattern, text, audio and / or visual alert or announcement, transmittable data, and the like. It will be appreciated that the examples above are non- exhaustive and the quality or grade of the red blood cells and / or buffy coat platelets may be presented to the user in any other suitable format for indicating a relative condition of the red blood cells and / or buffy coat platelets.

[0031] The dominant or main wavelength of plasma may be determined during a blood separation process in the manner described in US Pat. Publication. No.2024 / 0027333, to Fenwal Inc., which is incorporated herein by reference in its entirety. In US Pat. Publication. No. 2024 / 0027333, in which the dominant wavelength is used to determine a grade for the plasma based on a color of the plasma, wherein the plasma color corresponds to different dominant wavelengths. Common plasma grades include, but are not limited to clear yellow plasma, red-tinted clear plasma, yellow lipemic plasma, red-tinted lipemic plasma and green plasma. The plasma grade, presented as a color in the example of aforementioned patent application, may then be used to determine the suitability of the graded plasma in particular plasma products. The dominant wavelength is determined during the manufacturing process and allows for automatic grading of the plasma before the process is completed.

[0032] In the present examples, a grade or quality of red blood cells and / or buffy coat platelets may be determined based on the dominant wavelength of the plasma. In this manner, the suitability of the red blood cells and / or the platelets in particular products may be determined before the separation process is completed. In some examples, if the dominant wavelength indicates red-tinted plasma, it may be indicative of red blood cell hemolysis produced from whole blood, and the quality or grade of thered blood cells may be determined as poor, since the red blood cells are likely hemolyzed cells. With such a grade, it may be recommended to discard or further evaluate the red blood cells after collection.

[0033] In another example, if the dominant wavelength indicates lipemic plasma, it may be determined that the grade or quality of platelets in the buffy coat is indicative of platelets which are unsuitable for a platelet product, and a recommendation may be made to discard the buffy coat instead of pooling with other buffy coats into a platelet product.

[0034] Thus, in the present examples, a quality or grade of red blood cells and / or buffy coat platelets may be automatically determined during the manufacturing process. Information indicative of the grade or quality may be provided to a data management system, to a user / operator of the blood processing system, for example by a display, and / or personnel associated with the process. Alternatively, or in addition, a recommendation may be provided regarding use of the red blood cells and / or platelets based on the grade determined during the manufacturing process.

[0035] The measured dominant wavelength of light (also referred to herein as a “main wavelength”) may be determined, for example, in the manner described in US Pat. Publication. No. 2024 / 0027333, to Fenwal Inc., which is incorporated herein by reference in its entirety. To this end, as described in US Pat. Publication. No. 2024 / 0027333, the present optical grading system 10 is configured to direct emitted light onto plasma, such that a portion of the light is reflected from the plasma. The optical grading system 10 is further configured to receive a portion of the reflected light and analyze the reflected light to determine the main wavelength of the light reflected from the plasma. The main wavelength substantially corresponds to a visible color of the plasma. By determining the main wavelength, the optical grading system 10 of the present examples may also be configured to determine a quality of the plasma, in the manner described in US Pat. Publication. No. 2024 / 0027333. Thus, the optical grading system 10 of the present examples may incorporate the systems and methods described in US Pat. Publication. No. 2024 / 0027333 to determine a quality or grade of the plasma, and may be further configured to determine a quality or grade of the red blood cells and buffy coat platelets based on the main wavelength of the plasma.

[0036] Referring now to FIG. 1 , an optical grading system 10 according to embodiments herein includes a broadband light source 12, an optical spectrometer 14 and a controller 16. The broadband light source 12 is configured to emit a light 18 having wavelengths in the visible range. In one example, the broadband light source 12 emits light 18 including at least all wavelengths in the visible range (from approximately 400 nm to approximately 700 nm). The broadband light source 12 may also emit light having wavelengths above and / or below the visible range. An example of a suitable broadband light source 12 includes a stabilized tungsten-halogen light source configured to emit a light 18 having all wavelengths between 360 nm and 2600 nm of the type marketed by Thorlabs, Inc. of Newton, New Jersey. It will be appreciated, however, that the broadband light source 12 may also be differently configured without departing from the scope of the present disclosure.

[0037] The broadband light source 12 is oriented to emit light 18 toward a vessel 20 having plasma 22 arranged therein. With reference to FIG. 2, the light 18 may be emitted by the broadband light source 12 and interact with the vessel 20 such that a first portion 24 of the light 18 is reflected off a surface of the vessel 20 (specular reflection), while a second portion 26 of the light 18 is transmitted through the surface of the vessel 20 and into the vessel 20. As described further below, the vessel 20 may be, for example, a fluid conduit containing plasma and / or a fluid container in which plasma is collected.

[0038] Referring again to FIG. 1 , the light 18 may be directed to strike the surface of the vessel 20 at an incidence angle 0. The incidence angle 0 may be selected to reduce the degree of specular reflection. For example, at an angle of 90 degrees ( / .e., normal to the vessel surface), there will tend to be a significant amount of specular reflection. On the other hand, if the angle 0 is 0 degrees, then the plasma 22 will not be exposed to the light 18. In the present embodiments, it has been found that an incidence angle 0 in the range of 30 degrees to 60 degrees may be advantageous for reducing the degree of specular reflection and producing more sensitive measurements. In one example, the angle 0 is approximately 45 degrees.

[0039] The broadband light source 12 may be oriented to direct the light 18 at the angle 0 with respect to the surface of the vessel 20. Alternatively, and with reference toFIGS. 1 and 3, the optical plasma grading system 10 may further include an optical fiber bundle 28 operably connected to the broadband light source 12. The optical fiber bundle 28 may include at least one optical transmission fiber 30 configured to pass at least a portion of the emitted light 18 from broadband light source 12 to vessel 20, and further, may direct the at least a portion of the light 18 onto the vessel 20 at the selected incidence angle 0.

[0040] In one embodiment, as shown in FIG. 3, the optical fiber bundle 28 includes a plurality of optical transmission fibers 30. For example, the optical fiber bundle 28 may include six optical transmission fibers 30. However, it will be appreciated that the illustrated configuration of the optical fiber bundle 28 is presented for the purposes of example only, and that other configurations may also be employed. For example, in other embodiments, the optical fiber bundle 28 may include more optical transmission fibers 30 or fewer optical transmission fibers 30. In one example, the optical fiber bundle 28 may include only a single optical transmission fiber 30.

[0041] With reference to FIGS. 2 and 4, when light 18 emitted from the broadband light source 12 strikes the surface of the vessel 20, the first portion 24 of the light 18 is reflected as specular reflection and the second portion 26 of the light 18 is transmitted through the surface of the vessel 20 and into vessel 20 ( / .e., to the plasma 22) at an angle according to Snell’s Law. A portion 32 of the transmitted ( / .e., second) portion 26 of the light 18 is reflected back out of the vessel 20 by the plasma 22 for receipt by the optical spectrometer 14. This reflected portion 32 of the transmitted portion 26 of the light 18 may be referred to herein as the plasma reflected light 32.

[0042] The optical spectrometer 14 is configured to analyze at least a portion of the received plasma reflected light 32. In one example, the optical spectrometer 14 is configured to analyze the received plasma reflected light by measuring and differentiating the wavelengths contained in the at least a portion of the received plasma reflected light 32 to produce an optical spectrum of the plasma reflected light 32. As shown in the example of FIG. 5, an intensity of the plasma reflected light 32 at the different wavelengths may be determined from the optical spectrum of the plasma reflected light 32. The optical spectrometer 14 is further configured to determine a main or dominant wavelength associated with the plasma 22 from the optical spectrum in aknown manner, for example, by using a conventional color specification system, which may be software of the type marketed by Thorlabs, Inc. An example of a suitable optical spectrometer 14 includes a compact CCD spectrometer capable of measuring the intensity of light at each wavelength in the range of 200 nm - 1000 nm of the type marketed by Thorlabs, Inc., but may also be differently configured without departing from the scope of the present disclosure.

[0043] As shown in FIGS. 1 and 3, the optical fiber bundle 28 may also be operably coupled to the optical spectrometer 14 and include at least one optical reception fiber 34. The at least one optical reception fiber 34 is configured to receive at least a portion of the plasma reflected light 32 and pass the received plasma reflected light 32 to the optical spectrometer 14.

[0044] In one example, as shown in FIG. 3, the optical reception fiber 34 may be centrally arranged relative to the plurality of the optical transmission fibers 30, at least at an end of the optical fiber bundle 28 from which the light 18 is directed to the vessel 20 and plasma reflected light 32 is received. An example of a suitable optical fiber bundle 28 includes a Thorlabs 200 urn Fiber Bundle Reflection Probe marketed by Thorlabs, Inc. It will be appreciated, however, the optical fiber bundle 28 may also be differently configured without departing from the scope of the present disclosure.

[0045] The controller 16 may be variously configured without departing from the scope of the present disclosure. In one embodiment, and with reference to FIGS. 6 and 7, controller 16 may include one or more electrical circuits designed to carry out the actions described herein. For example, the controller 16 may include a processor 36, implemented as microprocessor 36 and / or other circuits, circuitry or processors. The microprocessor 36 may include multiple physical and / or virtual processors. In addition, the controller 16 may include, or be operably connected to, one or more memories 38. Instructions 40 by which the microprocessor 36 is programmed may be stored on the memory 38 associated with the microprocessor 36, which memory / memories 38 may include one or more tangible non-transitory computer readable memories, having computer executable instructions stored thereon, which when executed by the microprocessor 36, may cause the microprocessor 36 to carry out one or more actions as described herein. In various examples, the controller 16 may control the light source12 and / or the optical spectrometer 14 to perform the operations described in the present examples, and thus, may be considered to perform the operations via the light source 12 and / or optical spectrometer 14.

[0046] It will be appreciated that, in general, light emitted onto a vessel and into a fluid sample may be transmitted through the fluid sample typically scattering as it propagates (diffuse transmission), absorbed by the fluid sample, and / or reflected ( / .e., diffuse reflectance) by the fluid sample. A fluid without cellular content, typically exhibits relatively low scattering, for example, as compared to whole blood and blood components, which are turbid media. Such blood and blood components typically exhibit low to moderate absorption and strong scattering properties.

[0047] In the present examples, the controller 16 is configured to determine a quality of red blood cells and / or buffy coat platelets based at least on the main wavelength of plasma, for example, as described in the aforementioned US Pat. Publication. No. 2004 / 0027333. Referring again to FIG. 7, the controller 16 may store, for example in a memory 38 of the one or more memories, grading information 42. As shown in FIGS. 7 and 8, the grading information 42 may include or be associated with stored wavelength information 44, stored red blood cell grade information 46, stored buffy coat platelet grade information 50 and / or stored plasma grade information 52. The stored red blood cell grade information 46, buffy coat platelet grade information 50 and / or plasma grade information 52 may include one or more known grades for red blood cells, buffy coat platelets, and / or plasma, respectively.

[0048] The stored wavelength information 44 may be associated with the red blood cell grade information 46, buffy coat platelet grade information 50 and optionally, the plasma grade information 52. The stored wavelength information 44 includes a plurality of stored wavelengths and / or wavelength ranges (Ai, K2, A3, A4...). The stored wavelength or wavelength ranges may be associated with at least one known grade of the red blood cell grade information 46 and / or buffy coat platelet grade information 50, and / or, in some examples, the plasma grade information 52.

[0049] In one example, the stored wavelength information 44 may be associated with the red blood cell grade information 46, buffy coat platelet grade information 50 and / or the plasma grade information in one or more tables stored in the memory 38, forexample, as shown in FIG. 8. It will be appreciated however, that the grading information 42 may be stored in a variety of suitable formats and is not limited to the examples above. For instance, the wavelength information 44 may include stored information in addition to or derived from the stored wavelengths or wavelength ranges referenced above.

[0050] In the illustrated example of FIG. 8, the stored red blood cell grade information 46 may include information relating to at least two red blood cell grades RBCGi, RBCG2. Similarly, the stored buffy coat platelet grade information 50 may include information relating to at least two buffy coat platelet grades BCPG1, BCPG2. In an example in which plasma is graded, the stored plasma grade information 52 may include information relating to four plasma grades PG1, PG2, PG3, PG4. It is understood that the above-referenced grades are provided as non-exhaustive and non-limiting examples. For instance, fewer or additional grades may be included with the grade information of the red blood cells 46, buffy coat platelets 50 and / or plasma 52.

[0051] The stored wavelengths or wavelength ranges of wavelength information 44 may generally correspond to visible colors upon which grades may be manually assigned to red blood cells, buffy coat platelets and / or plasma in conventional processes. It is understood that the above-referenced wavelengths and / or wavelength ranges of wavelength information 44 are provided as non-exhaustive and non-limiting examples. For instance, fewer or additional wavelengths or wavelength ranges may be included with wavelength information 44.

[0052] In the non-limiting example of FIG. 8, each stored grade of the red blood cell grade information 46 and the buffy coat platelet grade information 50 corresponds to at least one wavelength or wavelength range of wavelength information 44.Optionally, where plasma grade information 52 is included, each stored plasma grade of the plasma grade information 52 may also correspond to a wavelength or wavelength range of wavelength information 44. Further still, in some examples, the red blood cell grade information 46 and / or the buffy coat platelet grade information may correspond to one or more plasma grade of the plasma grade information 52. The controller 16 is configured to determine a grade of the red blood cells, buffy coat platelets, and / or optionally plasma 22 based on the main wavelength and the grading information 42. Forexample, the controller 16 may compare the main wavelength associated with plasma 22, determined as detailed above, to the plurality of stored wavelengths or wavelength ranges (e.g., A-i, A2, A3, A4 ...) of the wavelength information 44, and identify a stored wavelength or wavelength range which corresponds to the main wavelength. The controller 16 may determine a grade of the red blood cells, buffy coat platelets and / or plasma 22 to be the stored grade of one or more of the red blood cell grade information 46, the buffy coat platelet grade information 50 and / or the plasma grade information 52 associated with the identified stored wavelength or wavelength range corresponding to the main wavelength. For instance, with further reference to the example of FIG. 8, where the main wavelength Amain is equal to a stored wavelength A2, the controller 16 may determine the plasma grade for plasma 22 to be the stored plasma grade PG2 associated with the stored wavelength A2and the buffy coat platelet grade BCPG1 also associated with stored wavelength A2.

[0053] The controller 16 may also be configured to generate an output indicative of the determined grade of the red blood cells and / or the buffy coat platelets. The controller 16 may also generate an output indicative of the determined grade for the plasma. In some examples, the controller 16 may include, or be operably connected to, a user interface device 48, such as a touchscreen display. The output may be provided to a user via the user interface device 48, for example, as a visual display, graphic or text. Alternatively, or in addition, the user interface device 48 may include a speaker for providing an audible output indicative of the determined grade. In some examples, the controller 16 may be integrated with the optical spectrometer 14. In other examples, the controller 16 may be connected to the optical spectrometer 14 and configured to communicate with the optical spectrometer 14 such that various information may be exchanged between the optical spectrometer 14 and the controller 16 and / or may be transmitted from the optical spectrometer 14 to the controller 16 or vice versa. In other examples, the controller 16 and / or the user interface device 48 may be provided as part of a separate device or system with which the optical spectrometer 14 may operate in combination.

[0054] Alternatively, or in addition, as another output, the controller 16 may be configured to transmit information indicative of the determined grade to a datamanagement system, where information relating to various aspects of blood manufacturing processes may be stored. Thus, the controller 16 may be configured to communicate with one or more other devices using known, suitable wired and / or wireless communication devices and protocols. In one example, the system 10 (including controller 16) is communicably connected to one or more other devices in a communication network. In still further examples, the controller 16 may be configured to determine a recommendation based on the grade or quality of the red blood cells and / or the buffy coat platelets. For example, a recommendation may be stored in the memory 38 which corresponds to one or more grades of the red blood cells and / or buffy coat platelets. Thus, the controller 16 may determine a grade or quality of the red blood cells and / or buffy coat platelets based on the main wavelength, and may further determine a recommendation associated with the determined grade. The output from the controller 16 may thus be one or more of the determined grade and the recommendation. As one example, where the controller 16 determines the red blood cells to have a poor grade, the controller 16 may then determine a recommendation indicating that the red blood cells should be discarded or further evaluated upon completion of the process. The grade and / or the recommendation may be output, for example, to a user via user interface 48 and / or to a data management system.

[0055] Referring now to FIG. 9, a method 510 for grading or characterizing red blood cells and / or buffy coat platelets during a manufacturing or separation process according to embodiments of the present disclosure includes, for example, emitting 520 a light 18 including wavelengths in a visible spectrum and directing 530 the emitted light 18 onto a vessel 20 at the incidence angle 0. A portion 26 of the emitted light may be transmitted through the vessel 20 to plasma 22 contained in the vessel 20, and a further portion 32 of the light 26 may be reflected by the plasma 22. The method 510 also includes receiving 540 at least a portion of the plasma reflected light 32 at an optical spectrometer 14 and analyzing 550 the received plasma reflected light 32 to determine 560 a main or dominant wavelength of the received plasma reflected light 32. The method 510 further includes determining 570 a red blood cell grade for red blood cells based on the main wavelength, wavelength information 44 and the grading information 42. That is, the red blood cells may be graded ( / .e., assigned a grade) using the storedred blood cell grade of red blood cell grade information 46 associated with a stored wavelength or wavelength range of wavelength information 44 which corresponds to the main wavelength 54 (which may be stored in memory 38).

[0056] The method 510 also includes determining 580 a buffy coat platelet grade for platelets in the buffy coat based on the main wavelength, wavelength information 44 and grading information 42. For example, the platelets in plasma 22 may be graded using the stored buffy coat platelet grade of buffy coat platelet grade information 50 associated with a stored wavelength or wavelength range of wavelength information 44 which corresponds to the measured or determined main wavelength.

[0057] Optionally, in some embodiments, method 510 may include determining 590 a plasma grade of plasma 22 based on the main wavelength 54, wavelength information 44 and grading information 42. For example, the plasma 22 may be graded using the stored plasma grade of plasma grade information 52 associated with a stored wavelength or wavelength range of wavelength information 44 which corresponds to the measured or determined main wavelength 54.

[0058] In still other examples, the method 510 may include determining the plasma grade of plasma 22 and then determining the red blood cell grade and / or the buffy coat platelet grade based on the plasma grade.

[0059] In some embodiments, directing 530 the emitted light 18 from the broadband light source 12 onto the vessel 20 surface may include directing the light 18 onto the vessel 20 surface with at least one optical transmission fiber 30 of an optical fiber bundle 28. The at least one optical transmission fiber 30 may be oriented to direct the emitted light 18 onto the vessel 20 surface at the predetermined incidence angle 0. In addition, receiving 540 reflected light from the plasma 22, i.e., the plasma reflected light 32, may include receiving the plasma reflected light 32 with at least one optical reception fiber 34 of the optical fiber bundle 28 such that the optical spectrometer 14 receives the plasma reflected light 32 via the at least one optical reception fiber 34. In some examples, the optical reception fiber 34 may be centrally arranged relative to a plurality of optical transmission fibers 30.

[0060] Analyzing 550 the received, plasma reflected light 32 may include measuring and differentiating wavelengths of the received, plasma reflected light 32 andproducing an optical spectrum of the plasma reflected light 32. Analyzing 550 the received, plasma reflected light 32 may also include determining an intensity of the plasma reflected light 32 at the different wavelengths from the optical spectrum. The main wavelength associated with the plasma 22 may be determined 560 from the optical spectrum.

[0061] Determining 570 the red blood cell grade may include comparing the main wavelength of plasma 22 to one or more stored wavelengths or wavelength ranges of the wavelength information 44, wherein one or more stored wavelengths or wavelength ranges are associated with a corresponding stored red blood cell grade of the red blood cell grade information 46. The method 510 may further include identifying a stored wavelength or wavelength range that corresponds with the main wavelength and determining 570 the red blood cell grade from the plasma 22 based on the stored red blood cell grade associated with the identified stored wavelength or wavelength range. In other examples, as referenced above, the red blood cell grade may be determined based on the plasma grade.

[0062] Determining 580 the buffy coat platelet grade may include comparing the main wavelength (of plasma 22) to one or more stored wavelengths or wavelength ranges of the wavelength information 44, wherein one or more stored wavelengths or wavelength ranges are associated with a corresponding stored buffy coat platelet grade of the buffy coat platelet grade information 50. The method 510 may further include identifying a stored wavelength or wavelength range that corresponds with the main wavelength and determining 580 the buffy coat platelet grade from the plasma 22 based on the stored buffy coat platelet grade associated with the identified stored wavelength or wavelength range. In other examples, as referenced above, the buffy coat platelet grade may be determined based on the plasma grade.

[0063] Determining 590 the plasma grade may include comparing the main wavelength (of plasma 22) to one or more stored wavelengths or wavelength ranges of the wavelength information 44, wherein one or more stored wavelengths or wavelength ranges are associated with a corresponding stored plasma grade of the plasma grade information 52. The method 510 may further include identifying a stored wavelength or wavelength range that corresponds with the main wavelength of the plasma 22 anddetermining 590 the plasma grade based on the stored plasma grade associated with the identified stored wavelength or wavelength range. In some examples, the plasma grade may be determined before determining the red blood cell grade and / or the buffy coat platelet grade.

[0064] In some examples, the method 510 further includes generating an output indicative of the determined grade for any one of the red blood cells, buffy coat platelets and / or the plasma 22.

[0065] FIG. 10 shows another example of a method 610 for grading red blood cells and / or buffy coat platelets in a blood separation process. The method 610 may include, for example, beginning 620 a whole blood separation procedure and measuring 630 a main or dominant wavelength of light by separated plasma 22 during the blood separation procedure. The method 610 includes checking 640 whether the procedure is complete and waiting 645 a predetermined time if the procedure is not complete. After waiting the predetermined time, the method 610 returns to measuring 630 a main or dominant wavelength. If the procedure is complete, the method 610 may include averaging 650 stored main or dominant wavelength values of the plasma 22.

[0066] The method 610 further includes comparing 660 the average main or dominant wavelength of the plasma 22 to a predetermined color grading database. In one example, the predetermined color grading database may be stored in the memory 38, for example, as the grading information 42 ( / .e., the grading database 38 may be incorporated with the grading information 42). The method 610 may also include setting 670 the red blood cell grade, recommendation and / or display to user and / or send data indicative of red blood cell grade to management system. Alternatively or additionally, the method 610 may include setting 680 the buffy coat platelet grade 680, recommendation and / or display to user and / or send data indicative of the buffy coat platelet grade to a management system. In some examples, the method 610 may also include setting 690 a plasma grade, recommendation, and / or displaying the grade to a user and / or sending data indicative of the plasma grade to the data management system.

[0067] Thus, in the method 610, one or more of the red blood cell grade, the buffy coat platelet grade and the plasma grade may be determined according to the averagemain wavelength and the predetermined color grading database. The grades may include a recommendation with a qualitive grade or may include only one of the recommendation and the qualitive grade. The grades may be displayed to the user, for example, at a blood processing device 220 (FIG. 1 1 , discussed below) or other location, and / or send data indicative of the grade to a management system, where the data may be compiled, stored, further analyzed, viewed, etc. In some examples, the plasma grade may be determined according to the average main wavelength and the red blood cell grade and buffy coat platelet grade may be determined based on the plasma grade.

[0068] As indicated above, the present optical grading system 10 may be incorporated in or used in combination with a blood processing system and / or a blood component manufacturing system. An example of such a blood processing system and / or blood component manufacturing system is shown and described in WO 2021 / 194824 A1 to Fenwal, Inc., which is incorporated herein by reference in its entirety. It will be appreciated that reference is made to the blood processing system of WO 2021 / 194824 as an illustrative example of how the present optical grading system 10 may be used with a blood processing system to determine one or more of the red blood cell grade, buffy coat platelet grade and / or plasma grade. However, the optical grading system 10 of the present examples is not limited for use with such a blood processing system and may be used together with other suitable blood processing systems.

[0069] Referring generally to FIGS. 11 -13, a suitable blood processing system and / or blood component manufacturing system 210 generally includes a processing device 220 (FIG. 11 ) and a fluid flow circuit 320 (FIG. 12) selectively usable in combination with the processing device 220. For example, the fluid flow circuit 320 may be a disposable kit configured to be arranged on and interact with the processing device 220, such that components of the processing device 220 interact with corresponding components of the fluid flow circuit 320 to move fluid through the fluid flow circuit 320 in a controlled manner to perform a blood processing procedure. The fluid flow circuit 320 may be removed from the processing device 220 for disposal, for example, upon completion of a blood processing procedure.

[0070] In one example, the processing device 220 includes a pump system 222, a valve system 224, 244 and a centrifuge 228 and centrifuge drive unit (referred to collectively as a “centrifuge”). The processing device 220 may also include a sensor system 226, a microprocessor-based controller 230, and a user interface 232 configured to receive instructions from a user and output information to the user. The user interface 232 may be a touchscreen display. The processing device 220 may further include a nesting module 234 configured to interface with a cassette 330 (FIG. 12) of the fluid flow circuit 320 as described below. It will be appreciated, that in some examples, the microprocessor-based controller 230 and / or the user interface 232 may be integrated with the controller 16 and / or user interface device 48 described above with respect to the optical plasma grading system 10.

[0071] Referring now to FIGS. 12 and 13a-c, the fluid flow circuit 320 may generally include a plurality of fluid containers, such as a whole blood container 322, a plasma container 324, a red blood cell container 326, an additive container 328 and a buffy coat pooling container 329. The fluid flow circuit 320 may also include the flow control cassette 330 configured to be selectively coupled with the nesting module 234 of the processing device 220 and may further include a processing / separation chamber 332 configured to be received by the centrifuge 228.The fluid containers 322, 324, 326, 328, 329, flow control cassette 330 and processing / separation chamber 332 are interconnected to one another by conduits or tubing segments so as to permit continuous flow centrifugation.

[0072] With the fluid flow circuit 320 (FIGS. 12 and 13a-c) installed on processing device 220 (FIG. 11 ), the pump system 222, valve system 224, 244 and centrifuge 228 of the processing device 220 are selectively operable to draw whole blood from the whole blood container 322 or other source and direct the whole blood through a selected flow path for performing a selected blood processing or blood manufacturing procedure. In one example, as described further below, whole blood may be drawn from the whole blood container 322, directed to the separation chamber 332, and separated into plasma and red blood cell components by operation of the centrifuge 228 to interact with the separation chamber 332. The pump system 222 and valve system 224, 244 may be further operated to direct the separated blood components to correspondingfluid containers, e.g., to direct the plasma 22 to the plasma container 324 and red blood cells to the red blood cell container 326.

[0073] In the present examples, the pump system 222 is operated to cause fluid (e.g., whole blood) flow in the fluid flow circuit 320, and the valves 224, 244 may be operated to define different flow paths through the fluid flow circuit 320 depending on the selected blood processing or manufacturing procedure being performed and / or the stage of the selected blood processing or manufacturing procedure being performed. The cassette 330 is formed with a plurality of flow paths or conduits on a side facing the nesting module 234, and one or more of the valves 224, 244 may be arranged at the nesting module 234. The valves 224, 244 may be operated to selectively interact with the flow paths of the cassette 330 to either open or close various flow paths, and thereby define a flow path through the cassette 330.

[0074] According to one example, with reference to FIGS. 12-14, the optical grading system 10 may be configured to determine the main wavelength of plasma 22 along the flow path between the separation chamber 332 and the plasma container 324, and thus, may grade the plasma 22 in such a flow path. For example, the broadband light source 12 may be arranged to direct light onto a vessel 20 containing the plasma 22, such as a fluid conduit through which the plasma 22 flows generally at the flow control cassette 330. In such an example, the fluid conduit may be considered as the vessel 20 described above. Thus, the plasma 22, i.e., the separated plasma 22 flowing from the separation chamber 332 to the plasma container 324, is moving through the fluid conduit while the optical grading system 10 operates to determine a main wavelength or average main wavelength of the plasma 22.

[0075] In another example, with reference to FIGS. 12-15, the optical grading system 10 may be configured to determine the main wavelength of the plasma 22 stored in the plasma container 324, and thus, may grade the plasma 22 in the container 324. For example, the broadband light source 12 may be arranged to direct light 18 onto the plasma container 324 and receive light reflected from the plasma 22, i.e., the plasma reflected light 32. In such an example, the plasma container 324 may be considered as the vessel 20 described above. Further, in such an example, the plasma 22, i.e., the plasma 22 stored in the plasma container 324, is substantially stationarywhile the optical grading system 10 operates to determine the main wavelength of the plasma 22.

[0076] Referring to FIGS. 11 and 13a-c, the pump system 222 of the processing device 220 may include a first pump 222a for pumping whole blood, a second pump 222b for pumping plasma 22 and a third pump 222c for pumping additive solution. The pumps 222a-c may be provided as peristaltic pumps capable of receiving tubing or conduits and moving fluid at various rates through the associated conduit dependent upon the procedure being performed.

[0077] The valves 224 include clamps 224a, 224b, 224c. The clamps 224a-c are configured to open and close fluid paths through the tubing or conduits and may incorporate RF sealers in order to complete a heat seal of the tubing or conduit placed in the claim to seal the tubing or conduit leading to one or more fluid container 322, 324, 326, 328, 329 upon completion of a procedure.

[0078] As previously indicated, the user interface 232 may be provided as a touchscreen configured to enable user interaction with the processing device 210 and / or monitor various procedure parameters. In one example, the output indicative of the plasma grade may be provided to the touchscreen 232 to inform the user of the plasma grade determined for plasma 22.

[0079] Now referring to FIGS. 11 -13, the flow control cassette 330 is configured to route the fluid flow through three tubing loops 334a, 334b, 334c with each loop being positioned to engage a particular one of the pumps 222a, 222b, 222c. The conduit or tubing may extend through the cassette 330, or the cassette 330 may have preformed fluid flow paths that direct the fluid flow.

[0080] The microprocessor-based controller 230 of the processing device 220 may be configured to direct operations the blood processing or manufacturing system 210. The controller 230 may include a programmable microprocessor to automatically control the operation of the pump system 222, the valve system 224, 244 etc. The processing device 220 may also include wireless communication capabilities to enable transfer of data from the processing device 220 to, for example, a quality or data management system of an operator.

[0081] The processing device 220 may also include hangers 236a-d configured for supporting (e.g., suspending), various fluid containers 322, 324, 326, 328, 329 of the fluid flow circuit 320. The hangers 236a-d may be mounted to a support 238 which is vertically translatable to improve transportability of the processing device 10. The present disclosure is not limited to the number of hangers illustrated, and it is appreciated that the processing device 220 may be provided with fewer or additional hangers in different examples.

[0082] The nesting module 234 is configured to receive various disposable cassette designs so that the system may be used to perform different types of procedures. Embedded within the illustrated cassette nesting module 234 are four valves 244a-d (collectively referred to herein as being part of the “valve system 224, 244”) for opening and closing fluid flow paths within the flow control cassette 330, and three pressure sensors 226a-c capable of measuring the pressure at various locations of the fluid flow circuit 320.

[0083] The controller 230 of the processing device 220 is pre-programmed to automatically operate the system to perform one or more standard blood processing procedures selected by an operator input to the touchscreen 232 and configured to be further programmed by the operator to perform additional blood processing procedures. The controller 230 may be pre-programmed to substantially automate a wide variety of procedures carried out by the blood processing or manufacturing system 210, including, but not limited to: red blood cell and plasma production from a single unit of whole blood, buffy coat pooling, buffy coat separation into a platelet product, glycerol addition to red blood cells, red blood cell washing, platelet washing and cryoprecipitate pooling and separation.

[0084] The pre-programmed blood processing procedures operate the system 210 at pre-set settings for flow rates and centrifugation forces, and the programmable controller 230 may be further configured to receive input from the operator as to one or more of flow rates and centrifugation forces for the standard blood processing procedure to override the pre-programmed settings.

[0085] In addition, the programmable controller 230 is configured to receive input from the operator through the touchscreen 232 for operating the system 210 to performa non-standard blood processing procedure. More particularly, the programmable controller 230 may be configured to receive input for settings for the non-standard blood processing procedure, including flow rates and centrifugation forces.

[0086] The controller 16 of the optical plasma grading system 10 may be separate from the controller 230 of the blood processing and collecting / manufacturing system 210. In some examples, the controllers 16, 230 may be arranged in communication with one another such that information may be transmitted / received between the controllers 16, 230. Alternatively, the controller 16 of the optical plasma grading system 10 and the controller 230 of the blood processing or collecting / manufacturing system 210 may be integrated and provided as a single controller configured to perform the operations detailed above with respect to both controllers.

[0087] It will be appreciated that the optical grading system 10 of the present embodiments may operate during various procedures, and procedure stages, performed by the blood processing system 210, including a blood separation procedure in which plasma, red blood cells and buffy coat may be collected.

[0088] An example of such a procedure is shown and described in aforementioned WO 2021 / 194824, incorporated herein by reference, the procedure including the follow stages: 1 ) a blood prime stage, 2) an establish separation stage, 3) a collection stage, 4) a red blood cell recovery stage, 5) buffy coat harvest stage, 6) an additive solution flush stage and 7) an air evacuation stage. In each stage, the processing device 220 operates the pumps 222a-222c, valves 224a-c, 244a-d and centrifuge in a controlled manner to direct fluid along various paths through the fluid flow circuit 320.

[0089] FIGS. 13a-13c illustrate examples of the flow paths and operations of the pumps 222a-222c, valves 224a-c, 244a-d and centrifuge 228 during the establish separation stage, the collection stage and the buffy coat harvest stage, respectively. It will be appreciated that FIGS. 13a-13c may be generally referenced for an understanding of the flow paths and operations described in the other stages below as well.

[0090] In the blood prime stage, the processing device 220 is operated to draw whole blood from the whole blood container 322 into the separation chamber 332 via lines L1 and L2. The whole blood exits the separation chamber 332 through two ports to be received in line L3 and line L4, respectively. The whole blood may then be received by the plasma container 324 via a path including lines L3 and L7, and via a path including lines L4, L5, L14, L15 and L7.

[0091] An example of the “establish separation” stage is illustrated in FIG. 13a. In the establish separation stage, whole blood is drawn into the separation chamber 332 via line L2 and the centrifuge 228 is operated to separate the whole blood into plasma and red blood cells. Plasma exits the separation chamber 332 into line L3 and is directed through lines L15 and L14. Red blood cells exit the separation chamber 332 into lines L4 and L5. The plasma and the red blood cells are rejoined as whole blood in line L8 and directed through line L9 to return to line L2 to recirculate the whole blood.

[0092] The optical grading system 10 may be configured to determine the main wavelength of the plasma at a location along line L3 after the plasma has been separated from the red blood cells. According to various examples herein, the optical grading system 10 may determine a grade for the red blood cells, buffy coat platelets and / or plasma based on the main wavelength of the plasma in this stage. If a grade is determined for any of the red blood cells, buffy coat platelets and / or plasma that is considered unsatisfactory for a particular product, the blood processing procedure may be stopped at an intermediate point and the procedure may optionally be terminated. Depending on the grade, fluid flow circuit 320 and / or the whole blood therein may be disposed of or the whole blood and / or the whole blood component parts in the fluid flow circuit 320 may be disposed of or flagged for further analysis and / or processing.

[0093] Thus, the optical grading system 10 of the present examples may allow for grading of red blood cells, buffy coat platelets and / or plasma during the blood processing procedure, and in some examples, during the establish separation stage of the procedure or other stage at which plasma has been separated from the whole blood and passes by the optical grading system 10, for example in line L3.

[0094] Referring to FIG. 13b, in the collection stage, whole blood is received in the separation chamber 332 via lines L1 , L2 and separated into plasma and red bloodcell components by operation of the centrifuge 228. Plasma exits the separation chamber 332 into line L3 and may be received by the plasma container 324 via lines L3 and L7. Red blood cells exit the separation chamber 332 into line L4 and may be received in the red blood cell container 326 via lines L4, L5, L1 1 and L12.

[0095] The optical grading system 10 may determine the main wavelength of the plasma in line L3 during the collection stage to determine a grade for the red blood cells, buffy coat platelets and / or plasma. Alternatively, or in addition, the optical grading system 10 may be arranged relative to the fluid flow circuit 320 to determine the main wavelength of the plasma in line L7 and / or in the plasma container 324, as described above with regard to FIG. 15.

[0096] In the red blood cell recovery stage, air is drawn into the separation chamber 332 from the plasma container 324 via lines L7 and L3. Air received in the separation chamber 332 causes residual red blood cells remaining in the separation chamber 332 after the collection stage to exit into line L4 and be received by red blood cell container 326 via lines L4, L5, L11 and L12. Additive solution may be added to the red blood cells in line L5 from the additive solution container 328 via line L10.

[0097] With reference to FIG. 13c, in the buffy coat harvest stage, air is drawn into the separation chamber 332 from the plasma container 324 via lines L7 and L3, causing buffy coat to exit the separation chamber 332 into line L4. The buffy coat may then be received in the buffy coat container 329 via lines L4, L5, L14 and L16.

[0098] In the solution flush stage, additive solution from the additive solution container 328 may be received in the red blood cell container 326 via lines L10, L5, L11 and L12. In the air evacuation stage, residual air is removed from the red blood cell container 326 and may be received in the additive solution container 328 or directed to another portion of the fluid flow circuit 320.

[0099] In various embodiments, the main wavelength determined by the optical grading system 10 may be stored, for example in a memory 38, as main wavelength information 54. The main wavelength information 54 may include one or more main wavelength values. Alternatively, or in addition, the main wavelength information 54 may include an average of the main wavelengths determined throughout a blood processing or manufacturing procedure performed by the system 210. In furtherexamples, the average main wavelength value may be used to determine the plasma grade for the plasma 22 and / or determine the grade of the red blood cells and / or the buffy coat platelets.

[0100] In one example, a facility’s data management system (not shown) may receive the determined red blood cell, buffy coat platelet and / or plasma grades from the system 10 and / or system 210. The data management system may be configured to determine a final application of the plasma e.g., fractionation, transfusion, cryoprecipitate, disposal, etc.) based on the determined grade. Alternatively, or in addition, a user of the system 10, 210 may determine the final application of the plasma 22 based on the determined plasma grade.

[0101] As previously indicated, the optical grading system 10 of the present description is configured to determine a quality or grade of red blood cells and / or buffy coat platelets based at least on the main wavelength of the plasma. Thus, the optical grading system 10 is configured to determine the quality or grade of the red blood cells and / or buffy coat platelets based on the visual appearance or quality of the plasma. In addition, the quality of the red blood cells and / or the buffy coat platelets may be determined during the manufacturing process, i.e., while the plasma is being processed by the blood processing or blood component collecting or manufacturing system 210. For example, the main wavelength of the plasma may be determined in a stage of the procedure in which plasma is separated from whole blood, before additional stages are performed.

[0102] The red blood cell and / or the buffy coat platelet grades may be associated with a suitable end use of each. In some examples, the characterization or grade may be a qualitive or quantitative description of the red blood cells and / or the buffy coat platelets, wherein the description is associated with the suitable end use. In some instances, the characterizations or grades may describe the end use itself.

[0103] In one example, the red blood cell grade may be indicative of red blood cell hemolysis, in which the red blood cells are likely hemolyzed. Such red blood cells are typically considered to be of poor quality and may be discarded. Red blood cell hemolysis may generally be indicated by a red-tinged plasma. Accordingly, in the present examples, where the determined main or dominant wavelength of the plasma22 is indicative of a red tinge, the system 10 may identify, from the wavelength information 44, a stored wavelength or wavelength range equal to or containing the determined wavelength. The system 10 may then identify the stored wavelength or wavelength range as corresponding to a red blood cell quality in which the red blood cells are likely hemolyzed, and thus, the red blood cells may be determined to be of a low quality and may be discarded or recommended for further evaluation.

[0104] It will be appreciated that other red blood cell quality characterizations or grades may be determined based on the main or dominant wavelength as well. In one example, the system 10 may determine the presence or absence of a particular red blood cell quality based on the main or dominant wavelength and may then characterize the red blood cells as either having or not having such a quality.

[0105] According to another example, the system 10 may determine if the plasma is lipemic plasma based on the main or dominant wavelength. If lipemic plasma is indicated, then the system 10 may determine the buffy coat platelet quality to be unsuitable for buffy coat pooling and packaging as a platelet product. If the buffy coat platelets are determined to be unsuitable, the system 10 may further recommend that the buffy coat be discarded rather than pooled. Conversely, the system 10 may be configured to determine that the main or dominant wavelength does not correspond to a wavelength or wavelength range of the wavelength information 44 indicative of lipemic plasma, and thus, determine that the plasma is not lipemic and the buffy coat is suitable for pooling. It will be appreciated that various other buffy coat platelet grades may be determined by the system 10 based on the measured main or dominant wavelength.

[0106] In the embodiments of the present application, red blood cell, buffy coat platelet and plasma grading may be automated by way of the optical grading system 10 by incorporating color measurement technology, for example, into a blood processing or manufacturing system 210. The embodiments of the present application may allow the system to automatically grade the plasma, red blood cells and / or buffy coat platelets which can then be displayed to a user / operator and / or sent to a facility’s data management system. In this manner, labor associated manual plasma, red blood cell, and / or platelet grading may be reduced and overall consistency in grading may be improved by removing human subjectivity or error. In addition, the grade of the plasma,red blood cells and / or buffy coat platelets may be determined during the blood processing procedure. Thus, it is not necessary to wait until all blood components (e.g., plasma, red blood cells, and buffy coat platelets) are collected and the procedure is completed to determine a grade for a particular blood component. In addition, by determining the plasma, red blood cell and / or buffy coat platelet grade during the blood processing procedure, the procedure may be terminated before completion if any of grades are unsuitable for packaging and / or downstream use.Aspects

[0107] Aspect 1 . A method for grading red blood cells and / or buffy coat platelets, the method comprising: emitting, from a broadband light source, light having wavelengths in a visible range; directing the emitted light to a vessel at an incidence angle; receiving, at an optical spectrometer, a reflected light portion of the emitted light; analyzing, with the optical spectrometer, at least a portion of the received reflected light to determine a main wavelength of the received reflected light; and determining, with a controller, the red blood cell grade and / or the buffy coat platelet grade using the main wavelength, wherein the main wavelength is the main wavelength of plasma within the vessel.

[0108] Aspect 2. The method of Aspect 1 , further comprising determining, with the controller, a plasma grade using the main wavelength.

[0109] Aspect 3. The method of Aspect 2, wherein the red blood cell grade and / or the buffy coat platelet grade are determined based on the plasma grade.

[0110] Aspect 4. The method of Aspect 1 or 2, wherein determining the red blood cell grade includes: comparing the main wavelength to one or more stored wavelengths or wavelength ranges associated with red blood cell grade information; identifying a stored wavelength or wavelength range to which the main wavelength corresponds; and determining the red blood cell grade based on stored red blood cell grade information associated with the identified stored wavelength or wavelength range.

[0111] Aspect 5. The method of Aspect 1 or 2, wherein determining the buffy coat platelet grade includes: comparing the main wavelength to one or more stored wavelengths or wavelength ranges associated with buffy coat platelet grade information;identifying a stored wavelength or wavelength range to which the main wavelength corresponds; and determining the buffy coat platelet grade based on stored buffy coat platelet grade information associated with the identified stored wavelength or wavelength range.

[0112] Aspect 6. The method of any one of the preceding Aspects, wherein the analyzing the received reflected light to determine the main wavelength includes determining the main wavelength as an average main wavelength.

[0113] Aspect 7. The method of any one of the preceding Aspects, further comprising generating an output indicative of the plasma grade corresponding to the main wavelength.

[0114] Aspect 8. A method for grading red blood cells and / buffy coat platelets during a blood processing procedure, the method comprising: providing whole blood to a separation chamber of a fluid flow circuit; operating a centrifuge of a processing device to separate the whole blood into plasma and red blood cells in the separation chamber; providing the plasma in a first vessel of the fluid flow circuit fluidically connected to the separation chamber; determining, by an optical grading system, a main wavelength of the plasma in the first vessel; determining, by the optical grading system, a red blood cell grade and / or a buffy coat platelet grade based on the main wavelength of the plasma.

[0115] Aspect 9. The method of Aspect 8, wherein the main wavelength is an average main wavelength.

[0116] Aspect 10. The method of Aspect 8, further comprising determining a plasma grade based on the main wavelength of the plasma.

[0117] Aspect 1 1 . The method of claim 10, further comprising providing a recommendation based on the determined red blood cell grade, the determined buffy coat platelet grade and / or the determined plasma grade.

[0118] Aspect 12. The method of Aspect 8 further comprising displaying the determined red blood cell grade, the determined buffy coat platelet grade and / or the determined plasma grade to a user.

[0119] Aspect 13. The method of Aspect 8, further comprising sending the determined red blood cell grade, the determined buffy coat platelet grade and / or the determined plasma grade to a data management system.

[0120] Aspect 14. A blood processing and / or manufacturing system, comprising: a processing device having pump system, a valve system, a centrifuge and a nesting module; a fluid flow circuit having a plurality of fluid containers, a flow control cassette, and a separation chamber interconnected with one another with a plurality of fluid vessels, wherein the flow control cassette is removably connected to the processing device at the nesting module and interfaces with one or more pumps of the pump system and one or more valves of the valve system, wherein the separation chamber is received in the centrifuge, and wherein the processing device is selectively operable to interact with the fluid flow circuit to perform a blood separation procedure having one or more stages in which the centrifuge is operated to separate whole blood into plasma and red blood cells in the separation chamber and the plasma exits the separation chamber into a first vessel of the plurality of fluid vessels; an optical grading system comprising a broadband light source, an optical spectrometer and a controller, wherein the optical grading system is arranged relative to the first vessel and configured to: determine a main wavelength of the plasma in the first vessel, determine a red blood cell grade and / or a buffy coat platelet grade based on the main wavelength of the plasma.

[0121] Aspect 15. The system of Aspect 14, wherein the controller is further configured to determine a plasma grade based on the main wavelength of the plasma.

[0122] Aspect 16. The system of Aspect 14 or 15, wherein the first vessel is a conduit fluidically connected to the separation chamber into which the separated plasma is received from the separation chamber or a plasma container fluidically connected to the conduit and configured to receive the plasma from the separation chamber via the conduit.

[0123] Aspect 17. The system of any one of Aspects 14-16, wherein the optical grading system is configured to determine the red blood cell grade and / or the buffy coat platelet grade during the blood separation procedure.

[0124] Aspect 18. The system of Aspect 17, wherein the processing device is configured to stop the blood separation procedure before completion depending on the red blood cell grade and / or the buffy coat platelet grade.

[0125] Aspect 19. The system of any one of Aspects 14-18, wherein the blood separation procedure includes at least an establish separation stage and a collection stage in which the plasma exits the separation chamber into the first vessel.

[0126] Aspect 20. A blood processing and / or manufacturing system comprising: a processing device; a fluid flow circuit selectively arranged on the processing device, wherein the processing device is configured to interact with the fluid flow circuit to perform one or more blood separation procedures in which plasma is separated from whole blood; and an optical grading system arranged relative to a first vessel of the fluid flow circuit containing the separated plasma, wherein the optical grading system is configured to determine a main wavelength of the plasma in the first vessel and determine a red blood cell grade and / or a buffy coat platelet grade based on the main wavelength of the plasma.

[0127] It will be understood that the embodiments and examples described above are illustrative of some of the applications of the principles of the present subject matter. Numerous modifications may be made by those skilled in the art without departing from the spirit and scope of the claimed subject matter, including those combinations of features that are individually disclosed or claimed herein. For these reasons, the scope hereof is not limited to the above description but is as set forth in the following claims, and it is understood that claims may be directed to the features hereof, including as combinations of features that are individually disclosed or claimed herein.

Claims

CLAIMS1 . A method for grading red blood cells and / or buffy coat platelets, the method comprising: emitting, from a broadband light source, light having wavelengths in a visible range; directing the emitted light to a vessel at an incidence angle; receiving, at an optical spectrometer, a reflected light portion of the emitted light; analyzing, with the optical spectrometer, at least a portion of the received reflected light to determine a main wavelength of the received reflected light; and determining, with a controller, the red blood cell grade and / or the buffy coat platelet grade using the main wavelength, wherein the main wavelength is the main wavelength of plasma within the vessel.

2. The method of claim 1 , further comprising determining, with the controller, a plasma grade using the main wavelength.

3. The method of claim 2, wherein the red blood cell grade and / or the buffy coat platelet grade are determined based on the plasma grade.

4. The method of claim 1 or 2, wherein determining the red blood cell grade includes: comparing the main wavelength to one or more stored wavelengths or wavelength ranges associated with red blood cell grade information; identifying a stored wavelength or wavelength range to which the main wavelength corresponds; and determining the red blood cell grade based on stored red blood cell grade information associated with the identified stored wavelength or wavelength range.

5. The method of claim 1 or 2, wherein determining the buffy coat platelet grade includes:comparing the main wavelength to one or more stored wavelengths or wavelength ranges associated with buffy coat platelet grade information; identifying a stored wavelength or wavelength range to which the main wavelength corresponds; and determining the buffy coat platelet grade based on stored buffy coat platelet grade information associated with the identified stored wavelength or wavelength range.

6. The method of any one of the preceding claims, wherein the analyzing the received reflected light to determine the main wavelength includes determining the main wavelength as an average main wavelength.

7. The method of any one of the preceding claims, further comprising generating an output indicative of the plasma grade corresponding to the main wavelength.

8. A method for grading red blood cells and / buffy coat platelets during a blood processing procedure, the method comprising: providing whole blood to a separation chamber of a fluid flow circuit; operating a centrifuge of a processing device to separate the whole blood into plasma and red blood cells in the separation chamber; providing the plasma in a first vessel of the fluid flow circuit fluidically connected to the separation chamber; determining, by an optical grading system, a main wavelength of the plasma in the first vessel; and determining, by the optical grading system, a red blood cell grade and / or a buffy coat platelet grade based on the main wavelength of the plasma.

9. The method of claim 8, wherein the main wavelength is an average main wavelength.

10. The method of claim 8, further comprising determining a plasma grade based on the main wavelength of the plasma.1 1 . The method of claim 10, further comprising providing a recommendation based on the determined red blood cell grade, the determined buffy coat platelet grade and / or the determined plasma grade.

12. The method of claim 8 further comprising displaying the determined red blood cell grade, the determined buffy coat platelet grade and / or the determined plasma grade to a user.

13. The method of claim 8, further comprising sending the determined red blood cell grade, the determined buffy coat platelet grade and / or the determined plasma grade to a data management system.

14. A blood processing and / or manufacturing system, comprising: a processing device having a pump system, a valve system, a centrifuge and a nesting module; a fluid flow circuit having a plurality of fluid containers, a flow control cassette, and a separation chamber interconnected with one another with a plurality of fluid vessels, wherein the flow control cassette is removably connected to the processing device at the nesting module and interfaces with one or more pumps of the pump system and one or more valves of the valve system, wherein the separation chamber is received in the centrifuge, and wherein the processing device is selectively operable to interact with the fluid flow circuit to perform a blood separation procedure having one or more stages in which the centrifuge is operated to separate whole blood into plasma and red blood cells in the separation chamber and the plasma exits the separation chamber into a first vessel of the plurality of fluid vessels; and an optical grading system comprising a broadband light source, an optical spectrometer and a controller, wherein the optical grading system is arranged relative to the first vessel and configured to: determine a main wavelength of the plasma in the first vessel,determine a red blood cell grade and / or a buffy coat platelet grade based on the main wavelength of the plasma.

15. The system of claim 14, wherein the controller is further configured to determine a plasma grade based on the main wavelength of the plasma.

16. The system of claim 14 or 15, wherein the first vessel is a conduit fluidically connected to the separation chamber into which the separated plasma is received from the separation chamber or a plasma container fluidically connected to the conduit and configured to receive the plasma from the separation chamber via the conduit.

17. The system of any one of claims 14-16, wherein the optical grading system is configured to determine the red blood cell grade and / or the buffy coat platelet grade during the blood separation procedure.

18. The system of claim 17, wherein the processing device is configured to stop the blood separation procedure before completion depending on the red blood cell grade and / or the buffy coat platelet grade.

19. The system of any one of claims 14-18, wherein the blood separation procedure includes at least an establish separation stage and a collection stage in which the plasma exits the separation chamber into the first vessel.

20. A blood processing and / or manufacturing system comprising: a processing device; a fluid flow circuit selectively arranged on the processing device, wherein the processing device is configured to interact with the fluid flow circuit to perform one or more blood separation procedures in which plasma is separated from whole blood; and an optical grading system arranged relative to a vessel of the fluid flow circuit containing the separated plasma, wherein the optical grading system is configured to determine a main wavelength of the plasma in the first vessel and determine a redblood cell grade and / or a buffy coat platelet grade based on the main wavelength of the plasma.

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