Dynamic adjustment of light intensity and / or signal amplification in optical sensor assembly for centrifugal separator

Abstract

To provide dynamic adjustment of light intensity and / or signal amplification of an optical sensor assembly of a centrifugal separator during a biological fluid separation procedure.SOLUTION: An optical sensor assembly of a centrifugal separator of a biological fluid separation system includes a light source configured to emit light having an intensity toward a separation chamber stored in the centrifugal separator. At least a part of the light is emitted from the separation chamber as transmitted light. A photodetector receives at least a part of the transmitted light as reception light and transmits a signal on the basis of the reception light. A control part receives the signal from the photodetector, and determines a position of an interface between two components separated in the separation chamber on the basis of at least a part of the signal. The control part is programmed so as to determine as to whether to control the light source for dynamically adjusting the light intensity during a biological fluid separation procedure and / or whether to control the photodetector for dynamically adjusting signal amplification during the procedure.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present subject matter relates to systems and methods for centrifuging biological fluids. More particularly, the present subject matter relates to dynamic adjustment of light intensity and / or signal amplification of an optical sensor assembly of a centrifuge during a biological fluid separation procedure. [Background technology]

[0002] Various blood processing systems allow for the collection of specific blood components, rather than whole blood, from a blood source, such as a human donor or patient. Typically, such systems involve the collection of whole blood from the blood source, the separation, removal, and collection of specific blood components or constituents, and the return of the remaining blood components to the blood source. Removal of only specific components is advantageous when the blood source is a donor because it may require less time for the donor's body to return to normal or pre-donation levels. Also, donations of specific blood components or constituents may be more frequent than when whole blood is collected. This increases the overall supply of blood components, such as plasma and platelets, available for transport and / or treatment or medical care.

[0003] Whole blood can be separated into its components, typically by centrifugation. This requires passing the blood through a centrifuge after it is withdrawn from a blood source and before it is returned to the blood source. To reduce the possibility of contamination or infection, when the blood source is a donor or patient, the blood is preferably contained and processed within a disposable, sealed, sterile fluid flow circuit throughout the centrifugation process. The disposable flow circuit includes a separation chamber portion, which the operator attaches to a durable, reusable centrifuge assembly containing reusable hardware (e.g., centrifuge, drive system, pump, valve actuator, programmable controller, etc.). This assembly is attached to and interfaces with the hardware to rotate the separation chamber during use and control flow through the disposable flow circuit. The centrifuge assembly engages and rotates the separation chamber of the fluid flow circuit during the separation procedure. However, the only actual contact the blood has with the fluid flow circuit, which is used only once and then discarded.

[0004] Before or immediately after loading the disposable circuit into the centrifuge assembly, the operator typically inputs, for example, by a touchscreen or other user interface system, the specific processing protocol to be executed by the system (e.g., the procedure for separating and collecting platelets from whole blood) and other parameters (e.g., donor weight, desired volume of separated blood components to be collected, etc.). Once the system is programmed, the operator phlebotomizes the donor, and the system executes the procedure under the operator's supervision.

[0005] As the centrifuge assembly rotates the separation chamber of the disposable flow circuit, heavier (higher specific gravity) components of the whole blood in the separation chamber, such as red blood cells, move radially outward, away from the center of rotation, toward the outer, or "high-G," wall of the separation chamber. Lighter (lower specific gravity) components, such as plasma, move toward the inner, or "low-G," wall of the separation chamber. By including appropriately positioned channeling structures and outlet ports within the separation chamber of the disposable flow circuit, various components can be selectively removed from the whole blood. For example, therapeutic plasma exchange involves separating plasma from cellular blood components, collecting the plasma, and returning the cellular blood components and replacement fluid to the blood source. Alternatively, red blood cells can be harvested from the separation chamber, and the remaining blood components can be returned to the donor. Other processes are also possible, including, but not limited to, platelet collection, red blood cell exchange, plasma exchange, or a combination of the above collections.

[0006] Optimal separation requires that the interface between separated blood components be located at a target position between the high-G and low-G walls of the separation chamber, as shown in Figure 1. For example, when performing therapeutic plasma exchange procedures, the interface between plasma and cellular blood components affects system performance. If the interface is too close to the low-G wall (as shown in Figure 2), the collected plasma may contain too much or be contaminated with cellular blood components. On the other hand, if the interface is too far from the low-G wall (as shown in Figure 3), the plasma may not be contaminated, but less plasma may be collected over time, reducing the system's separation efficiency.

[0007] Various centrifuges, such as those shown and described in U.S. Patent No. 6,254,784 to Nayak et al., U.S. Patent No. 10,768,107 to Koudelka et al., and U.S. Patent No. 11,465,160 to Min et al. (incorporated herein by reference), are operable to automatically maintain an interface at a target position while the centrifuge is operating. In these three systems, a transparent or translucent inclined surface 10 (FIGS. 1-3) is associated with the radially outer wall 12 of the separation chamber 14, allowing light from a light source to enter the separation chamber 14 and encounter the fluid being separated or one or more separated fluid components therein. When blood is being separated, the interface 16 between a generally dark, opaque red blood cell layer 18 and a generally bright, transparent plasma layer 20 appears as a line on the inclined surface 10. The position of the line on the inclined surface 10 is a function of the radial position of the interface 16 between the red blood cells 18 and the plasma 20 within the channel 22 defined by the high-G wall 12 and low-G wall 24 of the separation chamber 14. Therefore, the position of the line on the inclined surface 10 can be used to measure the position of the interface 16 between the high-G wall 12 and the low-G wall 24 .

[0008] Automatic control of the interface position is achieved by sensing the position of the line on the inclined surface and then adjusting the centrifuge's operating parameters to position and maintain the line within desired limits. For example, by controlling the rate at which plasma is withdrawn from the separation chamber, the line can be "moved" upward (radially inward by increasing the plasma flow rate) or downward (radially outward by decreasing the plasma flow rate) on the inclined surface. Optical sensor assemblies may be used to sense the position of the line on the inclined surface. Optical control systems generally operate on the principle that optically transparent fluids, such as saline and / or plasma (including platelet-rich or platelet-poor plasma), transmit light, while optically dense fluids, such as whole blood or red blood cell concentrates, do not. Therefore, similar to conventional systems, a light source and detector device can be used to measure an optical signal representing the thickness of the optically transparent fluid in the centrifuge and apply it to determine, correct, and maintain the position of the red blood cell / plasma interface.

[0009] More specifically, as the centrifuge rotates the separation chamber, the inclined surface rotates in and out of the path of light emitted from the light source. When an optically transparent or translucent fluid (e.g., saline or plasma) is aligned with the light source, the light passes through the fluid and is received by the photodetector. As the photodetector receives light from the light source, it generates a signal having a voltage corresponding to the intensity of the light received by the photodetector, and the signal is received by the controller. In other cases (e.g., when the inclined surface is misaligned with the light source or when the light encounters an optically opaque fluid, such as red blood cells, on the inclined surface), the light is not transmitted to the photodetector, and the photodetector either does not send a signal to the controller or sends a "low" signal having a voltage significantly lower than the voltage of the signal generated when the photodetector receives light.

[0010] Thus, the photodetector receives a high amount of light for a period of time during each rotation of the centrifuge, corresponding to the time the optically transparent or translucent fluid on the inclined surface is aligned with the light source. The signal transmitted by the photodetector during light reception and received by the controller has both a magnitude (voltage) and a duration, sometimes referred to as a "pulse width." As the interface position within the separation chamber channel approaches the high-G wall of the separation chamber (as in Figure 3), the signal's pulse width increases. As the interface position approaches the low-G wall (as in Figure 2), the signal's pulse width decreases. The controller compares the pulse width of each signal with a target pulse width corresponding to the desired position of the interface within the separation chamber channel (see Figure 1) and appropriately adjusts the operation of other system components (e.g., by changing the rate at which plasma is withdrawn from the separation chamber) to move the interface toward the desired position. (If the measured pulse width equals the target pulse width, the controller determines that the interface is at the desired position.)

[0011] Figures 4-6 show exemplary signals corresponding to different fluid conditions within the separation chamber. Figure 4 shows the signal generated by the photodetector when saline is flowing through the separation chamber. This can occur at the beginning of the fluid separation procedure, during the priming phase of the procedure. Light from the light source passes through the saline and is received by the photodetector across the entire width of the inclined plane. As a result, the signal generated by the photodetector has a maximum pulse width (which varies depending on the width of the inclined plane and the rotational speed of the centrifuge). This signal, also known as the "saline calibration signal," may be used by the controller to calculate the position of the interface during the fluid separation procedure. This is discussed in more detail below.

[0012] FIG. 5 illustrates a signal generated by the photodetector when red blood cells (“RBCs”) occupy a relatively small percentage of the inclined surface width. As shown in FIG. 5 and described above, the photodetector transmits a signal with a relatively high voltage only when the optically transparent fluid (e.g., plasma) on the inclined surface is aligned with the light source. In the situation illustrated in FIG. 5, the plasma occupies only 75% of the inclined surface width, so the pulse width of the resulting signal is 75% of the pulse width of the saline calibration signal. In an exemplary embodiment, the target pulse width may be 60% of the saline calibration signal, in which case the controller takes appropriate action to cause the plasma to occupy a smaller percentage of the inclined surface width until the controller detects that the signal from the photodetector has a pulse width that is 60% of the saline calibration signal pulse width (corresponding to the target interface position illustrated in FIG. 1).

[0013] FIG. 6 illustrates the signal generated by the photodetector when red blood cells occupy a greater percentage of the inclined surface width. As shown in FIG. 6 and described above, the photodetector transmits a signal with a relatively high voltage only when the optically transparent fluid (e.g., plasma) on the inclined surface is aligned with the light source. In the situation illustrated in FIG. 6, the plasma occupies only 50% of the inclined surface width, so the pulse width of the resulting signal is 50% of the pulse width of the saline calibration signal. In an exemplary embodiment in which the target pulse width is 60% of the pulse width of the saline calibration signal, the controller takes appropriate action to cause the plasma to occupy a greater percentage of the inclined surface width until the controller detects that the signal from the photodetector has a pulse width that is 60% of the pulse width of the saline calibration signal.

[0014] While such optical sensor assemblies have proven effective, their operation can be impaired by various irregularities in the composition of the fluids being separated, the configuration of the separation chamber, and / or the configuration and / or operation of the centrifuge components. These irregularities can lead to inaccurate determination of the location of the interface, resulting in poor performance, separation, and / or product collection. For example, conditions such as lipemia (abnormally high lipid concentrations in the blood) reduce the optical clarity of plasma. In certain embodiments of the optical sensor assembly described above, the low-G side of the fluid gap defined by the angled surface is rotated to align with the light source before the high-G side, so that the rising edge of the signal indicates the nature of the fluid present on the low-G side of the fluid gap and the falling edge of the signal indicates the nature of the fluid present on the high-G side. The angled surface design used in all three systems ensures that the light from the light source passes through a greater radial thickness of fluid on the low-G side of the fluid gap than on the high-G side. Because the light must pass through different amounts of lipemic plasma at every point along the width of the inclined plane where plasma is present, different amounts of light pass through the plasma and are received by the photodetector during one rotation of the inclined plane past the light source. This results in a signal whose voltage varies along the pulse width, rather than a signal with a relatively uniform voltage, as shown in Figures 4-6. If the signal's pulse width were measured only at locations with a voltage above a minimum percentage of the maximum voltage, the calculated pulse width would be shorter than if the plasma were not lipemic, causing the controller to underestimate the percentage of the inclined plane width occupied by plasma. An incorrect determination of the interface position could cause the controller to improperly adjust the operating parameters of various centrifuge components, potentially causing the controller to move the interface to a location different from the target position.

[0015] Irregularities in hardware and disposable components include light sources that emit light that is too intense or too weak, and sloped surfaces that have depressions, cavities, or cracks or fissures. Solutions to these problems include replacing hardware components on a device-by-device basis, sorting light sources during manufacturing to achieve an optimal configuration, or redesigning the entire light sensor assembly to make it more robust. None of these options are cost-effective or necessarily feasible from a business perspective. Summary of the Invention

[0016] The present subject matter has several aspects that can be implemented individually or together in the devices and systems described and claimed below. These aspects can be used alone or in combination with other aspects of the subject matter described herein. Furthermore, the description of these aspects together does not preclude the use of these aspects individually or the claiming of such aspects individually or in different combinations as recited in the claims appended hereto.

[0017] In one embodiment, an optical sensor assembly for a biological fluid separation system is provided, the optical sensor assembly including a centrifuge configured to receive a separation chamber for separating a biological fluid into at least two separated components. The optical sensor assembly includes a light source, a photodetector, and a controller. The light source is configured to emit light having a first intensity toward the separation chamber, with at least a portion of the light being transmitted from the separation chamber. The photodetector is configured to receive at least a portion of the transmitted light as received light and transmit a signal having a voltage and a pulse width, the voltage being based at least in part on a second intensity of the received light. The controller is programmed to receive the signal from the photodetector and determine, at least in part, based on the signal, a position of an interface between at least two of the separated components in the separation chamber. The controller is further programmed to control the light source to dynamically adjust the first intensity during a biological fluid separation procedure and / or to dynamically adjust a signal amplification during a biological fluid separation procedure. [Brief explanation of the drawings]

[0018] FIG. 1 is an enlarged perspective view of a portion of a centrifuge chamber of conventional design, showing the centrifuged red blood cell layer, plasma layer, and interface within the chamber when in a target position on an inclined surface.

[0019] FIG. 2 is an enlarged perspective view of the separation chamber of FIG. 1, showing an interface within the chamber adjacent the low-G wall of the chamber and spaced from the target location.

[0020] FIG. 3 is an enlarged perspective view of the separation chamber shown in FIG. 1, showing an interface within the chamber adjacent the high-G wall of the chamber and spaced from the target location.

[0021] FIG. 4 is a schematic diagram of the optical signal generated by a conventional photodetector when monitoring a saline-filled centrifuge chamber.

[0022] 5 and 6 are schematic diagrams of the optical signal generated by a conventional optical detector when monitoring a centrifuge chamber filled with a biological fluid separated into two components.

[0023] FIG. 7 is a side view, partially cut away and in section, of a biological fluid separation system incorporating an embodiment of the present invention, showing the centrifuge bowl and spool of the system in their operating positions.

[0024] 8 is a top perspective view of a spool of a centrifuge equipped with the separation chamber shown in FIG.

[0025] FIG. 9 is a plan view of the separation chamber shown in FIG. 8, with the separation chamber removed from the spool.

[0026] FIG. 10 is a side perspective view of the bowl and spool of the centrifuge of FIG. 7, showing an optical sensor assembly carried by the yoke of the centrifuge for monitoring fluid separation within the centrifuge.

[0027] FIG. 11 is a cross-sectional side view of the bowl, spool, and optical sensor assembly when the viewing head is aligned with the inclined surface of the bowl.

[0028] FIG. 12 is a schematic diagram of selected components of the optical sensor assembly and a pump controlled by the optical sensor assembly control.

[0029] FIG. 13 is a perspective view of another embodiment of an exemplary centrifuge according to one aspect of the present disclosure, with a portion of the centrifuge bucket cut away for illustrative purposes.

[0030] FIG. 14 is a perspective view of yet another embodiment of an exemplary centrifuge according to an aspect of the present disclosure.

[0031] 15-20 are flowcharts of exemplary embodiments of techniques for determining whether dynamic adjustment of the light intensity and / or signal amplification of an optical sensor assembly is necessary, according to one aspect of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0032] The embodiments disclosed herein are intended to provide an illustration of the inventive subject matter, and it is understood that the inventive subject matter can be embodied in various other forms and combinations not specifically shown. Accordingly, the specific designs and features disclosed herein should not be construed as limiting the subject matter defined in the appended claims.

[0033] The optical sensor assemblies and optical interface monitoring techniques according to the present disclosure are described herein in the context of biological fluid separation systems that use inclined surfaces of the type described above, although it should be understood that biological fluid separation systems of different configurations (including those that omit the inclined surface as part of the interface detection assembly) can be used in combination with the optical sensor assemblies and techniques described herein.

[0034] 7-12 illustrate one embodiment of a biological fluid separation system 100 embodying aspects of the present disclosure. The biological fluid separation system 100 is configured generally in accordance with the system described in U.S. Patent No. 6,254,784 and also in accordance with the configuration of the AMICUS® separator sold by Fenwall, Inc. of Lake Zurich, Illinois, an affiliate of Fresenius Kabi AG of Bad Homburg, Germany.

[0035] Briefly, biological fluid separation system 100 comprises a centrifuge 102 configured to house a separation chamber 104 of a disposable fluid flow circuit 106 (FIG. 8), with separation chamber 104 removably disposed in a generally annular gap between an outer bowl 108 and an inner spool 110. Bowl 108 includes an opening or window 112 with an associated inclined surface 114, and spool 110 includes a mirror or reflector 116 aligned with inclined surface 114. FIG. 9 illustrates the position of inclined surface 114 relative to separation chamber 104 when separation chamber 104 is installed within centrifuge 102.

[0036] Selected components of optical sensor assembly 118 (FIGS. 10 and 11) are attached to a portion of centrifuge 102 that rotates during a biological fluid separation procedure (e.g., associated with yoke 120 of centrifuge 102). Optical sensor assembly 118 includes a light source 122 and a photodetector 124, which is electrically connected to a controller 126 (FIG. 12). Light source 122 (which may be configured, for example, as a laser or one or more light emitting diodes) emits light that passes through inclined surface 114 and fluid aligned with inclined surface 114 (as described above), and mirror or reflector 116 reflects the light that has passed through the fluid back through separation chamber 104 to photodetector 124 (which may be configured, for example, as a PIN diode detector). In accordance with the above description, photodetector 124 generates a signal based on the intensity of the received reflected light, which is transmitted to controller 126, which determines the location of the interface between the separated fluid components within separation chamber 104 and takes appropriate action to move the interface toward a target location. In the embodiment shown in FIG. 12 , controller 126 directs pump 128 associated with plasma outlet line 130 of fluid flow circuit 106 to adjust the rate at which plasma is removed from separation chamber 104 so that the interface moves in a desired direction, although controller 126 may be programmed to take any other corrective action without departing from the scope of the present disclosure.

[0037] For more information regarding the construction of the biological fluid separation system 100 and fluid flow circuit 106, and how the two cooperate to perform a biological fluid separation procedure, see US Pat. No. 6,254,784.

[0038] Figures 13 and 14 illustrate two alternative embodiments of the biological fluid separation system 100 of Figures 7-12. The embodiment of Figure 13 is configured generally according to the system described in U.S. Patent No. 10,768,107 and also generally according to the configuration of the AMICORE® separator sold by Fenwall, Inc. Compared to the biological fluid separation system 100 of Figures 7-12, the device of Figure 13 differs primarily in that its optical sensor assembly 118 is attached to a component of the centrifuge 102 that remains stationary during the biological fluid separation procedure (e.g., the housing or "bucket" of the centrifuge 102) rather than to a component that rotates during the biological fluid separation procedure. The optical sensor assembly 118 is otherwise configured and operates in accordance with the description above.

[0039] The embodiment of Figure 14 is configured generally in accordance with the system described in U.S. Patent No. 11,465,160. The embodiment of Figure 14 is similar to the embodiment of Figure 13 in that the components of the optical sensor assembly are configured to remain stationary during a biological fluid separation procedure, but the embodiment of Figure 14 employs a light source 122 that is spaced apart from the light detector 124 rather than positioned generally adjacent to the light detector 124. More specifically, the separation chamber 104a of Figure 14 is provided with a prismatic reflector 132 that receives light from the light source 122 (after the light has passed through the fluid in the separation chamber 104a) and directs the light along a path generally perpendicular to the light's initial path, with at least a portion of the redirected light being received by the light detector 124.

[0040] Furthermore, while the embodiments of FIGS. 7-13 employ separation chamber 104 formed of a relatively flexible material and used in combination with inclined surface 114 integrated into the centrifuge component, separation chamber 104a is instead formed of a rigid material, with an inclined surface integrated into separation chamber 104a aligned with prismatic reflector 132. Separation chamber 104a can be formed of a transparent or translucent material, in which case light from light source 122 always passes through the outer wall of separation chamber 104a and strikes the fluid within separation chamber 104a. However, light from light source 122 is directed toward photodetector 124 only if it passes through the inclined surface, passes through an optically transmissive fluid (e.g., plasma) aligned with the inclined surface, and reaches prismatic reflector 132. Thus, it can be seen that inclined surface and prismatic reflector 132 function similarly to the inclined surface and mirror or reflector of the embodiments of FIGS. 7-13, directing light to photodetector 124 and generating a signal having a voltage and pulse width as described above.

[0041] Regardless of the particular configuration of the optical sensor assembly, the controller 126 is programmed to dynamically adjust the intensity of light emitted by the light source 122 and / or the amplification of the signal sent from the photodetector 124 to the controller 126 during a biological fluid separation procedure. Figures 15-20 illustrate exemplary algorithms that may be executed by the controller 126 during a biological fluid separation procedure to determine whether to adjust the intensity of light emitted from the light source 122 and / or the amplification of the signal sent from the photodetector 124 to the controller 126. Figures 15-17 illustrate how the controller 126 analyzes the voltage of the signal received from the light source 122, and Figures 18-20 illustrate how the controller 126 uses both the voltage and pulse width of the signal to calculate and analyze an integrated signal value.

[0042] It should be understood that the illustrated algorithms are merely exemplary and may be modified without departing from the scope of the present disclosure. For example, while FIGS. 15-20 refer to the voltage of a "signal" or the integrated signal value of a "signal," any algorithm may include an initial sampling step and / or preliminary step of calculating an average to provide the "signal" to be analyzed. As an example, this may involve the controller 126 determining the median voltage of a portion of the signal or across the recorded pulse width by sampling and averaging (e.g., by sorting a set of voltage values) before determining any necessary adjustments. The result of such an initial or preliminary step is treated as the "signal" to be analyzed using the algorithm or approach of the present disclosure. If desired, the algorithm may include additional steps to identify and possibly remove outliers from the data set to ensure the integrity of the "signal" obtained using the initial or preliminary steps.

[0043] In the first step 200 of the procedure of FIG. 15, the controller 126 compares the voltage of the signal from the photodetector 124 to an “expected” voltage value. As explained, the “signal” and its voltage may be the result of one or more initial or preliminary steps, including sampling and / or averaging, in which case the voltage compared to the expected value may be, for example, the maximum voltage of the signal recorded during one or more subsequent pulse widths, the median voltage over a portion of the signal or the entire recorded pulse width, or the average voltage of the signal during the pulse width (the average value may be calculated according to any suitable method without departing from the scope of this disclosure). The expected value may be pre-programmed into the controller 126 (including provided to the controller 126 by an operator at the start of the biological fluid separation procedure) or determined by the controller 126. For example, the controller 126 may select the expected value based on the voltage of a reference or calibration signal received by the controller 126 during a priming or calibration phase of the procedure, such as the “saline calibration signal” described above. The expected value may be equal to the voltage of the reference or calibration signal, or may be equal to a predetermined percentage of the voltage of such a signal (e.g., the expected value may be set to 75% of the voltage of the reference or calibration signal).

[0044] The next step in the procedure depends on the comparison performed in step 200. If the voltage of the signal received by controller 126 is equal to or greater than the expected voltage value, controller 126 proceeds to step 202, determines that no adjustment is necessary to either the intensity of the light emitted by light source 122 or the amplification of the signal emitted by photodetector 124, and makes no such adjustment. From there, controller 126 can either return to step 200 (to repeat the process for subsequent signals) or proceed to step 204, where the signal evaluation procedure ends (if controller 126 is programmed to check only once during the biological fluid separation procedure whether dynamic adjustments are necessary, or at least not to automatically repeat the procedure of FIG. 15 for subsequent signals).

[0045] On the other hand, if the voltage of the signal received by controller 126 is less than the expected voltage value, controller 126 proceeds to step 206, determines that a dynamic adjustment (increase) of the intensity of light emitted from light source 122 and / or the amplification of the signal emitted from photodetector 124 is necessary, and implements such adjustment. The precise adjustment performed by controller 126 in step 206 can take any of a variety of possible forms. For example, controller 126 can command only light source 122 to emit a higher intensity of light in step 206, with the magnitude of the change determined based on the difference between the voltage values ​​compared in step 200. In another embodiment, controller 126 commands only photodetector 124 (including commanding an amplification component or module of photodetector 124) to increase the amplification of the signal generated by photodetector 124, again with the magnitude of the change determined based on the difference between the voltage values ​​compared in step 200. In yet another embodiment, the control unit 126 can command the light source 122 to emit light having a higher intensity and also command the photodetector 124 to increase the amplification of the signal generated by the photodetector 124, both changes being signaled by the difference in the voltage values ​​compared in step 200.

[0046] After making the dynamic adjustment in step 206, the control unit 126 can either return to step 200 (to repeat the process for subsequent signals) or proceed to step 204 to end the signal evaluation procedure (if the control unit 126 is programmed to check only once during the biological fluid separation procedure whether dynamic adjustment is necessary, or at least if the control unit 126 is programmed not to automatically repeat the procedure of Figure 15 for subsequent signals).

[0047] In one embodiment, controller 126 may be programmed to first adjust the signal amplification in step 206 before adjusting the light intensity based on an assumption that light source 122 is operating properly and that the low voltage signal is due to an abnormality in the biological fluid (e.g., if the separated plasma is lipemic). If controller 126 repeatedly performs the steps of Figure 15 on subsequent signals and finds in step 200 that adjusting the signal amplification was not effective in making the voltage of the subsequent signal at least equal to the expected value, controller 126 may command light source 122 to increase the light intensity in step 206 to see if such adjustment is more effective in increasing the voltage of the subsequent signal.

[0048] 16 illustrates a variation of the algorithm of FIG. 15 in which, in step 300, instead of determining whether the voltage of the signal is less than an expected value, the controller 126 determines whether the voltage of the signal is greater than an expected value. If the voltage of the signal received by the controller 126 is less than or equal to the expected voltage value, the controller 126 proceeds to step 302, where it determines that no adjustment is necessary to either the intensity of the light emitted from the light source 122 or the amplification of the signal emitted from the photodetector 124, and makes no such adjustment. From there, the controller 126 can either return to step 300 (to repeat the process for subsequent signals) or proceed to step 304, where the signal evaluation procedure ends (if the controller 126 is programmed to check only once during the biological fluid separation procedure whether dynamic adjustments are necessary, or at least not to automatically repeat the procedure of FIG. 16 for subsequent signals).

[0049] On the other hand, if the voltage of the signal received by the controller 126 is greater than the expected voltage value, the controller 126 proceeds to step 306, determines that a dynamic adjustment (decrease) of the intensity of light emitted from the light source 122 and / or the amplification of the signal emitted from the photodetector 124 is necessary, and implements such adjustment. The precise adjustment performed by the controller 126 in step 306 can take any of a variety of possible forms. For example, the controller 126 can instruct only the light source 122 to emit a lower intensity of light in step 306, with the magnitude of the change based on the difference between the voltage values ​​compared in step 300. In another embodiment, the controller 126 instructs only the photodetector 124 (including instructing an amplification component or module of the photodetector 124) to decrease the amplification of the signal generated by the photodetector 124, again with the magnitude of the change determined based on the difference between the voltage values ​​compared in step 300. In yet another embodiment, the control unit 126 can instruct the light source 122 to emit light having a lower intensity and can also instruct the photodetector 124 to decrease the amplification of the signal generated by the photodetector 124, both changes being signaled by the difference between the voltage values ​​compared in step 300.

[0050] After making the dynamic adjustment in step 306, the control unit 126 can either return to step 300 (to repeat the process for subsequent signals) or proceed to step 304, where the signal evaluation procedure ends (if the control unit 126 is programmed to check only once whether dynamic adjustment is necessary during the biological fluid separation procedure, or at least if it is programmed not to automatically repeat the procedure of FIG. 16 for subsequent signals).

[0051] In one embodiment, based on an assumption that light source 122 is operating properly and that the high voltage signal is due to signal fluctuations compared to the baseline (e.g., white blood cell and / or red blood cell contamination of the platelet product), controller 126 can be programmed to first adjust the signal amplification in step 306 before adjusting the light intensity. If controller 126 repeatedly performs the process of FIG. 16 on subsequent signals and finds in step 300 that adjusting the signal amplification was not effective in reducing the voltage of the subsequent signal to at least equal the expected value, controller 126 will command light source 122 to reduce the light intensity in step 306 to see if such an adjustment would be more effective in reducing the voltage of the subsequent signal.

[0052] The procedure of FIG. 17 is similar to the procedures of FIGS. 15 and 16, except that rather than comparing the voltage of a signal to a single expected voltage value (as in step 200 of FIG. 15 and step 300 of FIG. 16), the voltage of one or more signals is compared to an “expected” voltage range (step 400). As explained, the voltage compared to the expected range may be the result of one or more initial or preliminary steps, such as the median voltage of a portion of the signal or across a recorded pulse width, or the average voltage of the signal during the pulse width. The range of expected values ​​may be preprogrammed into the controller 126 (including provided to the controller 126 by an operator at the start of the biological fluid separation procedure) or may be determined by the controller 126. For example, the controller 126 may select the range of expected values ​​based on the voltage of a reference or calibration signal received by the controller 126 during a priming or calibration phase of the procedure, such as the “saline calibration signal” described above. The range of expected values ​​can be based on a selected percentage of the voltage of the reference or calibration signal (e.g., the expected voltage range is set to 75-95% of the voltage of the reference or calibration signal).

[0053] The next step in the procedure depends on the comparison performed in step 400. If the voltage of the signal received by controller 126 is within the expected voltage range, controller 126 proceeds to step 402 and determines that no adjustment is necessary to either the intensity of the light emitted by light source 122 or the amplification of the signal emitted by photodetector 124, and makes no such adjustment. From there, controller 126 can either return to step 400 (to repeat the process for subsequent signals) or proceed to step 404, where the signal evaluation procedure ends (if controller 126 is programmed to check only once during the biological fluid separation procedure whether dynamic adjustment is necessary, or at least not to automatically repeat the procedure of FIG. 17 for subsequent signals).

[0054] On the other hand, if the voltage of the signal received by controller 126 is outside the expected voltage range, controller 126 proceeds to step 406, determines that dynamic adjustment of the intensity of light emitted from light source 122 and / or the amplification of the signal emitted from photodetector 124 is necessary, and performs such adjustment. The precise adjustment performed by controller 126 in step 406 can take any of a variety of possible forms. For example, controller 126 in step 406 could only command light source 122 to emit only a higher intensity of light (if the voltage is below the expected voltage range) or a lower intensity of light (if the voltage is above the expected voltage range), with the magnitude of the change determined based on the difference between the voltage values ​​compared in step 400. In another embodiment, controller 126 may instruct only photodetector 124 (which may include instructions to an amplification component or module of photodetector 124) to increase the amplification of the signal produced by photodetector 124 (if the voltage is below the expected voltage range) or decrease the amplification of the signal (if the voltage is above the expected voltage range), again with the magnitude of the change determined based on the difference between the voltage values ​​compared in step 400. In yet another embodiment, controller 126 may instruct light source 122 to emit a different intensity of light and instruct photodetector 124 to adjust the signal amplification, with both changes signaled by the difference in the voltage values ​​compared in step 400.

[0055] After making the dynamic adjustment in step 406, the control unit 126 can either return to step 400 (to repeat the process for subsequent signals) or proceed to step 404 to end the signal evaluation procedure (if the control unit 126 is programmed to check only once during the biological fluid separation procedure whether dynamic adjustment is necessary, or at least if the control unit 126 is programmed not to automatically repeat the procedure of Figure 17 for subsequent signals).

[0056] In one embodiment, if the voltage is below the expected voltage range, based on a presumption that light source 122 is operating properly and the low voltage signal is due to an abnormality in the biological fluid (e.g., if the separated plasma is lipemic), controller 126 may be programmed to first increase the signal amplification in step 406 before adjusting the light intensity. If controller 126 repeatedly performs the steps of FIG. 17 on subsequent signals and finds in step 400 that adjusting the signal amplification was not effective in increasing the voltage of the subsequent signal to within the expected range, controller 126 will command light source 122 to increase the light intensity in step 406 to see if such adjustment is more effective in increasing the voltage of the subsequent signal.

[0057] Similarly, if the voltage is outside the expected voltage range, the controller can be programmed to first reduce the signal amplification, based on the assumption that the default or initial intensity of light from light source 122 will not result in a signal having a voltage outside the expected range. If controller 126 repeatedly performs the steps of Figure 17 on subsequent signals, and finds in step 400 that adjusting the signal amplification was not effective in reducing the voltage of the subsequent signal to be within the expected range, controller 126 will instruct light source 122 to reduce the light intensity in step 406 to see if such an adjustment will be more effective in reducing the voltage of the subsequent signal.

[0058] Next, we will describe the protocol of FIG. 18. This is similar to the procedure of FIG. 15, except that the controller 126 must analyze both the voltage and pulse width of the signal from the photodetector 124, rather than only considering the signal voltage. In the first step 500 of the procedure of FIG. 18, the controller 126 calculates an integrated signal value of the signal from the photodetector 124, where the integrated signal value represents the area under the curve representing the signal (FIGS. 4-6 show exemplary signal curves). The integrated signal value can be calculated by multiplying the signal's voltage by the pulse width, calculating the integral of the curve (an approximation of the area under the curve representing the signal), or by any other suitable method. This may include calculating only a portion of the signal curve (e.g., considering only the portion of the curve where the signal's voltage is at least a minimum percentage of the maximum voltage). Additionally, the integrated signal value may be the result of acquiring one or more subsequent signals (e.g., by sampling) and averaging the integrated signal values ​​of the set of signals, as previously described.

[0059] Next, in step 502, the controller 126 compares the integrated signal value to an “expected” integrated signal value. The expected integrated signal value may be pre-programmed into the controller 126 (including provided to the controller 126 by an operator at the start of a biological fluid separation procedure) or may be determined by the controller 126. For example, the controller 126 may calculate the expected integrated signal value based on the voltage and pulse width of a reference or calibration signal received by the controller 126 during a priming or calibration phase of the procedure, such as the “saline calibration signal” described above. The expected integrated signal value may be calculated according to any suitable technique, although it may be advantageous to employ the same technique to calculate both the expected integrated signal value and the integrated signal value of the signal from the photodetector 124 analyzed during the biological fluid separation procedure. The expected integrated signal value may be equal to the integrated signal value of the reference or calibration signal, or may be equal to a predetermined percentage of the integrated signal value of such signal (e.g., the expected integrated signal value may be set to 75% of the integrated signal value of the reference or calibration signal).

[0060] The next step in the procedure depends on the comparison performed in step 502. If the integrated signal value of the signal received by controller 126 is equal to or greater than the expected integrated signal value, controller 126 proceeds to step 504 and determines that no adjustment is necessary to either the intensity of the light emitted by light source 122 or the amplification of the signal emitted by photodetector 124, and makes no such adjustment. From there, controller 126 can either return to step 500 (to repeat the process for subsequent signals) or proceed to step 506, where the signal evaluation procedure ends (if controller 126 is programmed to check only once during the biological fluid separation procedure whether dynamic adjustments are necessary, or at least not to automatically repeat the procedure of FIG. 18 for subsequent signals).

[0061] On the other hand, if the integrated signal value of the signal received by the controller 126 is less than the expected integrated signal value, the controller 126 proceeds to step 508, determines that a dynamic adjustment (increment) of the intensity of light emitted from the light source 122 and / or the amplification of the signal emitted from the photodetector 124 is necessary, and implements such adjustment. The precise adjustment performed by the controller 126 in step 508 can take any of a variety of possible forms. For example, the controller 126 can command only the light source 122 to emit a higher intensity of light in step 508, with the magnitude of the change determined based on the difference between the integrated signal values ​​compared in step 502. In another embodiment, the controller 126 commands only the photodetector 124 (including commanding an amplification component or module of the photodetector 124) to increase the amplification of the signal generated by the photodetector 124, again with the magnitude of the change determined based on the difference between the integrated signal values ​​compared in step 502. In yet another embodiment, the control unit 126 can instruct the light source 122 to emit light having a higher intensity and can also instruct the photodetector 124 to increase the amplification of the signal generated by the photodetector 124, both changes being signaled by the difference between the integrated signal values ​​compared in step 502.

[0062] After making the dynamic adjustment in step 508, the control unit 126 can either return to step 500 (to repeat the process for subsequent signals) or proceed to step 506, where the signal evaluation procedure ends (if the control unit 126 is programmed to check only once whether dynamic adjustment is necessary during the biological fluid separation procedure, or at least not to automatically repeat the procedure of FIG. 18 for subsequent signals).

[0063] In one embodiment, based on an assumption that light source 122 is operating properly and that a low integrated signal value is due to an irregularity in the biological fluid (e.g., if the separated plasma is lipemic), controller 126 may be programmed to first adjust the signal amplification in step 508 before adjusting the light intensity. If controller 126 repeatedly performs the steps of FIG. 18 on subsequent signals and finds in step 502 that adjusting the signal amplification was not effective in making the integrated signal value of the subsequent signal at least equal to the expected value, controller 126 may command light source 122 to increase the light intensity in step 508 to see if such adjustment is more effective in increasing the integrated signal value of the subsequent signal.

[0064] FIG. 19 illustrates a variation of the algorithm of FIG. 18 in which, in step 602, the controller determines whether the integrated signal value (calculated in step 600) is greater than the expected value, rather than whether it is less than the expected value. If the integrated signal value of the signal received by controller 126 is not greater than the expected integrated signal value, controller 126 proceeds to step 604, determines that there is no need to adjust either the intensity of the light emitted by light source 122 or the amplification of the signal emitted by photodetector 124, and makes no such adjustment. From there, controller 126 can either return to step 600 (to repeat the process for subsequent signals) or proceed to step 606, where the signal evaluation procedure ends (if controller 126 is programmed to check only once during the biological fluid separation procedure whether dynamic adjustments are needed, or at least not to automatically repeat the procedure of FIG. 19 for subsequent signals).

[0065] On the other hand, if the integrated signal value of the signal received by the controller 126 is greater than the expected integrated signal value, the controller 126 proceeds to step 608, determines that a dynamic adjustment (decrease) of the intensity of light emitted from the light source 122 and / or the amplification of the signal emitted from the photodetector 124 is necessary, and implements such adjustment. The precise adjustment performed by the controller 126 in step 608 can take any of a variety of possible forms. For example, the controller 126 can instruct only the light source 122 to emit a lower intensity of light in step 608, with the magnitude of the change based on the difference between the integrated signal values ​​compared in step 602. In another embodiment, the controller 126 can instruct only the photodetector 124 (including instructing an amplification component or module of the photodetector 124) to decrease the amplification of the signal generated by the photodetector 124, again with the magnitude of the change determined based on the difference between the integrated signal values ​​compared in step 602. In yet another embodiment, the control unit 126 can instruct the light source 122 to emit light having a lower intensity and can also instruct the photodetector 124 to decrease the amplification of the signal generated by the photodetector 124, both changes being signaled by the difference between the integrated signal values ​​compared in step 602.

[0066] After making the dynamic adjustment (decrease) in step 608, the control unit 126 can either return to step 600 (to repeat the process for subsequent signals) or proceed to step 606 to end the signal evaluation procedure (if the control unit 126 is programmed to check only once whether dynamic adjustment is necessary during the biological fluid separation procedure, or at least not to automatically repeat the procedure of Figure 19 for subsequent signals).

[0067] In one embodiment, based on an assumption that light source 122 is operating properly and that a high integrated signal value is due to signal fluctuations compared to the baseline (e.g., white blood cell and / or red blood cell contamination of the platelet product), controller 126 may be programmed to first adjust the signal amplification in step 608 before adjusting the light intensity. If controller 126 repeatedly performs the process of FIG. 19 for subsequent signals and finds in step 602 that adjusting the signal amplification was not effective in lowering the integrated signal value of the subsequent signal to at least equal the expected value, controller 126 may instruct light source 122 to reduce the light intensity in step 608 to see if such adjustment is more effective in lowering the integrated signal value of the subsequent signal.

[0068] The procedure of FIG. 20 is similar to that of FIGS. 18 and 19, except that after the controller 126 calculates the integrated signal value of one or more signals (step 700), rather than comparing the integrated signal value of the signal to a single expected integrated signal value (step 502 in FIG. 18 and step 602 in FIG. 19), the controller 126 compares the integrated signal value of the signal to a range of “expected” integrated signal values ​​(step 702). As explained, the integrated signal value compared to the range of expected values ​​may be the result of one or more initial or preliminary steps, and the integrated signal value may be, for example, the median integrated signal value over a portion of a signal or the entire recorded pulse width, or the average integrated signal value of the signal during the pulse width. The range of expected values ​​may be preprogrammed into the controller 126 (including provided to the controller 126 by an operator at the start of a biological fluid separation procedure) or may be determined by the controller 126. For example, the controller 126 may calculate the expected integrated signal value based on the integrated signal value of a reference signal or calibration signal received by the controller 126 during a priming or calibration phase of the procedure, such as the “saline calibration signal” described above. The range of expected values ​​can be based on a selected percentage of the integrated signal value of the reference signal or calibration signal (e.g., the range of expected integrated signal values ​​can be set to 75-95% of the integrated signal value of the reference signal or calibration signal).

[0069] The next step in the procedure depends on the comparison performed in step 702. If the integrated signal value of the signal received by controller 126 is within the range of expected integrated signal values, controller 126 proceeds to step 704 and determines that no adjustment is necessary to either the intensity of the light emitted by light source 122 or the amplification of the signal emitted by photodetector 124, and makes no such adjustment. From there, controller 126 can either return to step 700 (to repeat the process for subsequent signals) or proceed to step 706, where the signal evaluation procedure ends (if controller 126 is programmed to check only once during the biological fluid separation procedure whether dynamic adjustments are necessary, or at least not to automatically repeat the procedure of FIG. 20 for subsequent signals).

[0070] On the other hand, if the integrated signal value of the signal received by controller 126 is outside the expected range, controller 126 proceeds to step 708, determines that dynamic adjustment of the intensity of light emitted from light source 122 and / or the amplification of the signal emitted from photodetector 124 is necessary, and performs such adjustment. The precise adjustment performed by controller 126 in step 708 can take any of a variety of possible forms. For example, controller 126 in step 708 could command light source 122 to emit only a higher intensity of light (if the integrated signal value is below the expected range) or a lower intensity of light (if the integrated signal value is above the expected range), with the magnitude of the change determined based on the difference between the integrated signal values ​​compared in step 702. In another embodiment, controller 126 may instruct only photodetector 124 (which may include instructions to an amplification component or module of photodetector 124) to increase the amplification of the signal produced by photodetector 124 (if the integrated signal value is below the expected range) or decrease the signal amplification (if the integrated signal value is above the expected range), again with the magnitude of the change determined based on the difference between the integrated signal values ​​compared in step 702. In yet another embodiment, controller 126 may instruct light source 122 to emit light of a different intensity and instruct photodetector 124 to adjust the signal amplification, with both changes informed by the difference between the integrated signal values ​​compared in step 702.

[0071] After making the dynamic adjustment in step 708, the control unit 126 can either return to step 700 (to repeat the process for subsequent signals) or proceed to step 706, where the signal evaluation procedure ends (if the control unit 126 is programmed to check only once whether dynamic adjustment is necessary during the biological fluid separation procedure, or at least not to automatically repeat the procedure of Figure 20 for subsequent signals).

[0072] In one embodiment, if the integrated signal value is below the expected range, based on an assumption that light source 122 is operating properly and the low integrated signal value is due to an irregularity in the biological fluid (e.g., if the separated plasma is lipemic), controller 126 may be programmed to first increase the signal amplification in step 708 before adjusting the light intensity. If controller 126 repeatedly performs the steps of FIG. 20 for subsequent signals and finds in step 702 that adjusting the signal amplification was not effective in increasing the integrated signal value of the subsequent signal to within the expected range, controller 126 will instruct light source 122 to increase the light intensity in step 708 and determine whether such adjustment is more effective in increasing the integrated signal value of the subsequent signal.

[0073] Similarly, if the integrated signal value is outside the expected range, the controller can be programmed to first decrease the signal amplification, based on the assumption that the default or initial intensity of light from light source 122 will not result in a signal whose integrated signal value exceeds the expected range. If controller 126 repeatedly performs the process of Figure 20 for subsequent signals and finds in step 702 that adjusting the signal amplification was not effective in reducing the integrated signal value of the subsequent signal to within the expected range, controller 126 instructs light source 122 to decrease the light intensity in step 708 to see if such adjustment is more effective in reducing the integrated signal value of the subsequent signal.

[0074] As noted above, regardless of the version of the signal analysis protocol executed by the controller 126, the controller 126 can be programmed to execute the protocol one or more times during a single cycle of a biological fluid separation procedure. If the controller 126 is programmed to execute a protocol only once, the conditions under which the controller 126 executes the protocol may be varied without departing from the scope of the present disclosure. For example, the controller 126 may be programmed to execute the protocol only if a predetermined volume of biological fluid has been separated during the procedure. In another embodiment, the controller 126 may be programmed to execute the protocol only after a predetermined time has elapsed since the start of the procedure. In yet another embodiment, the controller 126 may be programmed to execute the protocol only when a specific procedural event or step occurs.

[0075] If the controller 126 is programmed to execute a protocol multiple times during a single cycle of a biological fluid separation procedure, the controller 126 can be programmed to execute the protocol for each signal received from the photodetector 124, or for fewer than all signals. For example, the controller 126 can be programmed to execute the protocol once for each step of a multi-step procedure, or once per predetermined time interval (e.g., once per minute). Executing a protocol multiple times during a single cycle of a biological fluid separation procedure can be advantageous in that the results of each execution of the protocol are stored by the controller 126 and can be used to assess the condition of the centrifuge 102 and / or the separation chambers 104, 104a. For example, in one embodiment, the controller 126 can be programmed to calculate the number of times dynamic adjustment of light intensity and / or signal amplification was required during the biological fluid separation procedure and, if the calculated number is determined to be at least equal to a maximum number, generate a warning indicating a possible abnormality in the centrifuge 102 and / or the separation chambers 104, 104a.

[0076] In another embodiment, the controller 126 may be programmed to determine a period of time during which dynamic adjustments of light intensity and / or signal amplification are necessary, and, if the calculated period is at least equal to the maximum duration, generate a warning indicating a possible anomaly in the centrifuge 102 and / or separation chamber 104, 104a. For example, if adjustments made over a one-minute period are insufficient to produce an acceptable signal, the controller 126 may generate a warning indicating a possible irregularity.

[0077] In yet another embodiment, the controller 126 may be programmed to determine the amount of time that elapses after a predetermined event before dynamic adjustment of light intensity and / or signal amplification is necessary, and, upon determining that the calculated time period is not at least equal to the minimum duration, generate a warning indicating a possible irregularity in the centrifuge 102 and / or separation chamber 104, 104a. For example, if an adjustment becomes necessary shortly after the start of a procedure or shortly after a previous adjustment of light intensity and / or signal amplification, the controller 126 may generate a warning indicating a possible irregularity.

[0078] If the controller 126 is programmed to generate an alert, it can be further programmed to provide additional information regarding the nature of any irregularities that may be occurring in the centrifuge 102 and / or separation chamber 104. For example, the controller 126 can be programmed to recognize that a trend in the voltage or integrated signal value of the series of signals indicates that the light source 122 is about to fail, and as a result, the alert generated by the controller 126 can include a suggestion to replace the light source 122. Similar programming (which may include programming that enables the controller 126 to use trend analysis and / or outlier analysis techniques) can enable the controller 126 to determine whether a depression or cavity exists in the slope, whether the slope is cracked or fissured, or to diagnose other possible irregularities. Additionally, the controller 126 can also be programmed to use machine learning techniques to improve its diagnostic capabilities over time.

[0079] The controller 126 can also be programmed to execute protocols upon the occurrence of certain events that may not occur during a biological fluid separation procedure. For example, the controller 126 can be programmed to execute a signal evaluation if a spillover occurs during the procedure, if there is a change in the blood processing rate of the separation procedure, if the procedure is paused or stopped, if an alert occurs (different from the alert generated by the controller 126 when it diagnoses a possible irregularity, as described above), or if the centrifuge 102 spins down.

[0080] It will be appreciated that the techniques described herein address the potential for inconsistencies in the overall light intensity of the optical sensor assembly and aid in improving the system through specific software design without overhauling the entire hardware design. Dynamically adjusting the light intensity at the light source and / or the optical signal amplitude at the amplifier circuit during a biological fluid separation procedure improves the assembly's ability to accurately maintain the target interface location, ensuring more efficient processing and improved product quality than would be expected using conventional techniques.

[0081] Aspects Aspect 1 1. An optical sensor assembly for a biological fluid separation system including a centrifuge configured to house a separation chamber for separating a biological fluid into at least two components, the optical sensor assembly comprising: The optical sensor assembly a light source configured to emit light having a first intensity toward the separation chamber, at least a portion of the light exiting the separation chamber as transmitted light; a photodetector configured to receive at least a portion of the transmitted light as received light and to transmit a signal having a voltage and a pulse width, the voltage being based at least in part on a second intensity of the received light; and a controller programmed to receive a signal from the photodetector and determine a location of an interface between two of the at least two separated components in the separation chamber based at least in part on the signal; The control unit is further programmed to control the light source to dynamically adjust the first intensity during a biological fluid separation procedure and / or to control the photodetector to dynamically adjust the signal amplification during a biological fluid separation procedure, the optical sensor assembly.

[0082] Aspect 2 The optical sensor assembly of embodiment 1, wherein the control unit is programmed to control the light source to dynamically adjust the first intensity during a biological fluid separation procedure based at least in part on the voltage of the signal, and / or to control the photodetector to dynamically adjust the amplification of the signal during a biological fluid separation procedure.

[0083] Aspect 3 The control unit Compare the voltage to the expected voltage, dynamically adjusting the first intensity and / or amplification when the voltage differs from the expected voltage; When the voltage is equal to the expected voltage, do not dynamically adjust the first intensity; 3. The optical sensor assembly of embodiment 2, wherein the amplification is not dynamically adjusted when the voltage is equal to the expected voltage.

[0084] Aspect 4 The control unit Compare the voltage to the expected voltage range, dynamically adjusting the first intensity and / or amplification when the voltage is outside of an expected voltage range; not dynamically adjusting the first intensity when the voltage is within an expected voltage range; 3. The optical sensor assembly of embodiment 2, wherein the amplification is not dynamically adjusted when the voltage is within an expected voltage range.

[0085] Aspect 5 The optical sensor assembly of embodiment 1, wherein the control unit is programmed to control the light source to dynamically adjust the first intensity during a biological fluid separation procedure and / or control the photodetector to dynamically adjust the amplification of the signal during a biological fluid separation procedure based at least in part on the voltage and pulse width of the signal.

[0086] Aspect 6 The control unit Calculate the integrated signal value, Comparing the integrated signal value to an expected integrated signal value; dynamically adjusting the first intensity and / or amplification when the integrated signal value differs from the expected integrated signal value; not dynamically adjusting the first intensity when the integrated signal value is equal to the expected integrated signal value; 6. The optical sensor assembly of embodiment 5, wherein the amplification is not dynamically adjusted when the integrated signal value is equal to the expected integrated signal value.

[0087] Aspect 7 The control unit Calculate the integrated signal value, comparing the integrated signal value to a range of expected integrated signal values; dynamically adjusting the first intensity and / or amplification when the integrated signal value is outside a range of expected integrated signal values; not dynamically adjusting the first intensity when the integrated signal value is within a range of expected integrated signal values; 6. The optical sensor assembly of embodiment 5, wherein the amplification is not dynamically adjusted when the integrated signal value is within a range of expected integrated signal values.

[0088] Aspect 8

[0023] Aspect 8. The optical sensor assembly of any one of aspects 1 to 7, wherein the control unit is programmed to determine whether to dynamically adjust the first intensity and / or amplification when a predetermined volume of biological fluid is separated during a biological fluid separation procedure.

[0089] Aspect 9

[0023] Aspect 8. The optical sensor assembly of any one of aspects 1 to 7, wherein the controller is programmed to determine whether to dynamically adjust the first intensity and / or amplification when a predetermined time elapses during a biological fluid separation procedure.

[0090] Aspect 10 8. The optical sensor assembly of any one of embodiments 1 to 7, wherein the controller is programmed to determine whether to dynamically adjust the first intensity and / or amplification when spillover occurs during a biological fluid separation procedure.

[0091] Aspect 11 8. The optical sensor assembly of any one of embodiments 1 to 7, wherein the control unit is programmed to determine whether to dynamically adjust the first intensity and / or amplification when there is a change in a rate at which the biological fluid is processed during a biological fluid separation procedure.

[0092] Aspect 12 8. The optical sensor assembly of any one of embodiments 1 to 7, wherein the control unit is programmed to determine whether to dynamically adjust the first intensity and / or amplification when a biological fluid separation procedure is paused or stopped.

[0093] Aspect 13 8. The optical sensor assembly of any one of claims 1 to 7, wherein the control unit is programmed to determine whether to dynamically adjust the first intensity and / or amplification when an alarm is detected during a biological fluid separation procedure.

[0094] Aspect 14 8. The optical sensor assembly of any one of claims 1 to 7, wherein the controller is programmed to determine whether to dynamically adjust the first intensity and / or amplification when a centrifuge spindown occurs during a biological fluid separation procedure.

[0095] Aspect 15 The control unit iteratively determining whether dynamic adjustment of the first intensity and / or amplification is necessary during a separation procedure of the biological fluid; First, determining the number of times the intensity and / or amplification require dynamic adjustment; Compare the number of times to the maximum number of times,

[0023] Embodiment 8. The optical sensor assembly of any one of embodiments 1 to 7, wherein the optical sensor assembly is programmed to generate an alert if the count is equal to or greater than a maximum count.

[0096] Aspect 16 The control unit iteratively determining whether dynamic adjustment of the first intensity and / or amplification is necessary during a separation procedure of the biological fluid; determining a period of time during which the first intensity and / or amplification requires dynamic adjustment; Compare the period to the maximum duration,

[0023] Embodiment 8. The optical sensor assembly of any one of embodiments 1 to 7, wherein the optical sensor assembly is programmed to generate an alert if the time period is equal to or greater than the maximum duration.

[0097] Aspect 17 The control unit determining when dynamic adjustment of the first intensity and / or amplification is first required during a separation procedure of a biological fluid; determining the time elapsed from the start of the procedure to the first dynamic adjustment of the intensity and / or amplification; Compare the elapsed time to the minimum duration,

[0023] Embodiment 8. The optical sensor assembly of any one of embodiments 1 to 7, wherein the optical sensor assembly is programmed to generate an alert when the elapsed time is less than or equal to a minimum duration.

[0098] Aspect 18 The control unit iteratively determining whether dynamic adjustment of the first intensity and / or amplification is necessary during a separation procedure of the biological fluid; determining an elapsed time between a previous adjustment to the first intensity and / or amplification and a current adjustment to the first intensity and / or amplification; Comparing the elapsed period to a minimum duration;

[0023] Embodiment 8. The optical sensor assembly of any one of embodiments 1 to 7, wherein the optical sensor assembly is programmed to generate an alert when the elapsed time is less than or equal to a minimum duration.

[0099] Aspect 19 The control unit iteratively determining whether dynamic adjustment of the first intensity and / or amplification is necessary during a separation procedure of the biological fluid; 19. The optical sensor assembly of any one of aspects 1 to 18, wherein the optical sensor assembly is programmed to use trend analysis and / or outlier analysis techniques during a biological fluid separation procedure to determine whether there are irregularities in the configuration of the separation chamber based on one or more dynamic adjustments made to the first intensity and / or amplification during the biological fluid separation procedure.

[0100] Aspect 20 The control unit iteratively determining whether dynamic adjustment of the first intensity and / or amplification is necessary during a separation procedure of the biological fluid; The optical sensor assembly of any one of aspects 1 to 19, programmed to use trend analysis and / or outlier analysis techniques during a biological fluid separation procedure to determine whether there are any irregularities in the configuration and / or operation of the centrifuge, light source, and / or photodetector based on one or more dynamic adjustments made to the first intensity and / or amplification during the biological fluid separation procedure.

[0101] Aspect 21

[0033] Embodiment 21. The optical sensor assembly of any one of embodiments 1 to 20, wherein the light source is configured to rotate with the centrifuge during a separation procedure of the biological fluid.

[0102] Aspect 22

[0033] Embodiment 21. The optical sensor assembly of any one of embodiments 1 to 20, wherein the light source is configured to remain stationary during a biological fluid separation procedure.

[0103] Aspect 23 21. The optical sensor assembly of any one of embodiments 1 to 20, wherein the optical detector is oriented to receive the received light in a direction substantially perpendicular to the direction in which the light is emitted from the light source.

[0104] It will be understood that the above-described embodiments illustrate some of the applications of the principles of the present invention. Various modifications, including combinations of features that are individually disclosed or claimed herein, may be made by those skilled in the art without departing from the spirit and scope of the invention as claimed. For these reasons, it is understood that the scope of the invention is not limited to the above description, but is set forth in the appended claims, which claims may be directed to features of the invention, including combinations of features that are individually disclosed or claimed herein.

Claims

1. 1. An optical sensor assembly for a biological fluid separation system including a centrifuge configured to house a separation chamber for separating a biological fluid into at least two components, the optical sensor assembly comprising: The optical sensor assembly includes: a light source configured to emit light having a first intensity toward the separation chamber, at least a portion of the light exiting the separation chamber as transmitted light; a photodetector configured to receive at least a portion of the transmitted light as received light and to transmit a signal having a voltage and a pulse width, the voltage being based at least in part on a second intensity of the received light; and a controller programmed to receive the signal from the photodetector and determine a location of an interface between two of the at least two separated components in the separation chamber based at least in part on the signal; The control unit is further programmed to control the light source to dynamically adjust the first intensity during a biological fluid separation procedure and / or to control the photodetector to dynamically adjust the signal amplification during a biological fluid separation procedure.

2. 10. The optical sensor assembly of claim 1, wherein the control unit is programmed to control the light source to dynamically adjust the first intensity during a biological fluid separation procedure and / or control the photodetector to dynamically adjust the amplification of the signal during a biological fluid separation procedure based at least in part on a voltage of the signal.

3. The control unit comparing the voltage to an expected voltage; dynamically adjusting the first intensity and / or the amplification when the voltage differs from the expected voltage; not dynamically adjusting the first intensity when the voltage is equal to the expected voltage; The optical sensor assembly of claim 2 , wherein the amplification is not dynamically adjusted when the voltage is equal to the expected voltage.

4. The control unit comparing the voltage to an expected voltage range; dynamically adjusting the first intensity and / or the amplification when the voltage is outside the expected voltage range; not dynamically adjusting the first intensity when the voltage is within the expected voltage range; The optical sensor assembly of claim 2 , wherein the amplification is not dynamically adjusted when the voltage is within the expected voltage range.

5. 2. The optical sensor assembly of claim 1, wherein the control unit is programmed to control the light source to dynamically adjust the first intensity during the biological fluid separation procedure and / or control the photodetector to dynamically adjust the amplification of the signal during the biological fluid separation procedure based at least in part on the voltage and the pulse width of the signal.

6. The control unit Calculate the integrated signal value, comparing the integrated signal value to an expected integrated signal value; dynamically adjusting the first intensity and / or the amplification when the integrated signal value differs from the expected integrated signal value; not dynamically adjusting the first intensity when the integrated signal value is equal to the predicted integrated signal value; The optical sensor assembly of claim 5 , wherein the amplification is not dynamically adjusted when the integrated signal value is equal to the expected integrated signal value.

7. The control unit Calculate the integrated signal value, comparing the integrated signal value to a range of expected integrated signal values; dynamically adjusting the first intensity and / or the amplification when the integrated signal value is outside the range of expected integrated signal values; not dynamically adjusting the first intensity when the integrated signal value is within the range of expected integrated signal values; 6. The optical sensor assembly of claim 5, wherein the amplification is not dynamically adjusted when the integrated signal value is within a range of expected integrated signal values.

8. 8. The optical sensor assembly of claim 1, wherein the control unit is programmed to determine whether to dynamically adjust the first intensity and / or the amplification when a predetermined volume of biological fluid is separated during the biological fluid separation procedure.

9. 8. The optical sensor assembly of claim 1, wherein the control unit is programmed to determine whether to dynamically adjust the first intensity and / or the amplification when a predetermined time has elapsed during the biological fluid separation procedure.

10. 8. The optical sensor assembly of claim 1, wherein the control unit is programmed to determine whether to dynamically adjust the first intensity and / or the amplification when spillover occurs during the biological fluid separation procedure.

11. 8. The optical sensor assembly of claim 1, wherein the control unit is programmed to determine whether to dynamically adjust the first intensity and / or the amplification when there is a change in the rate at which the biological fluid is processed during the biological fluid separation procedure.

12. 8. The optical sensor assembly of claim 1, wherein the control unit is programmed to determine whether to dynamically adjust the first intensity and / or the amplification when the biological fluid separation procedure is paused or stopped.

13. 8. The optical sensor assembly of claim 1, wherein the control unit is programmed to determine whether to dynamically adjust the first intensity and / or the amplification when an alarm occurs during the biological fluid separation procedure.

14. 8. The optical sensor assembly of claim 1, wherein the control unit is programmed to determine whether to dynamically adjust the first intensity and / or the amplification when a spin-down of the centrifuge occurs during a separation procedure of the biological fluid.

15. The control unit iteratively determining whether dynamic adjustment of the first intensity and / or the amplification is necessary during a separation procedure of the biological fluid; determining a number of times the first intensity and / or the amplification require dynamic adjustment; Comparing the number of times to a maximum number of times; The optical sensor assembly of claim 1 , programmed to generate an alert if the number is equal to or greater than the maximum number.

16. The control unit iteratively determining whether dynamic adjustment of the first intensity and / or the amplification is necessary during a separation procedure of the biological fluid; determining a time period during which the first intensity and / or the amplification requires dynamic adjustment; comparing said period to a maximum duration; 8. The optical sensor assembly of claim 1, programmed to generate an alert if the period is equal to or greater than the maximum duration.

17. The control unit determining when dynamic adjustment of the first intensity and / or the amplification is first required during a separation procedure of the biological fluid; determining the elapsed time from the start of the procedure to the first dynamic adjustment of the first intensity and / or the amplification; comparing the elapsed time to a minimum duration; The optical sensor assembly of claim 1 , programmed to generate an alert when the elapsed time is less than or equal to the minimum duration.

18. The control unit iteratively determining whether dynamic adjustment of the first intensity and / or the amplification is necessary during a separation procedure of the biological fluid; determining an elapsed time between a previous adjustment to the first intensity and / or the amplification and a current adjustment to the first intensity and / or the amplification; comparing the elapsed time period to a minimum duration; The optical sensor assembly of claim 1 , programmed to generate an alert when the elapsed time is less than or equal to the minimum duration.

19. The control unit iteratively determining whether dynamic adjustment of the first intensity and / or the amplification is necessary during a separation procedure of the biological fluid; 19. The optical sensor assembly of claim 1, wherein the optical sensor assembly is programmed to use trend analysis and / or outlier analysis techniques during the biological fluid separation procedure to determine whether there are any irregularities in the configuration of the separation chamber based on one or more dynamic adjustments made to the first intensity and / or the amplification during the biological fluid separation procedure.

20. The control unit iteratively determining whether dynamic adjustment of the first intensity and / or the amplification is necessary during a separation procedure of the biological fluid; 20. The optical sensor assembly of claim 1, wherein the optical sensor assembly is programmed to use trend analysis and / or outlier analysis techniques during the biological fluid separation procedure to determine whether there are any irregularities in the configuration and / or operation of the centrifuge, the light source, and / or the photodetector based on one or more dynamic adjustments made to the first intensity and / or the amplification during the biological fluid separation procedure.

21. 21. The optical sensor assembly of claim 1, wherein the light source is configured to rotate with the centrifuge during a separation procedure of the biological fluid.

22. 21. The optical sensor assembly of claim 1, wherein the light source is configured to remain stationary during the biological fluid separation procedure.

23. 21. The optical sensor assembly of claim 1, wherein the optical detector is oriented to receive the received light in a direction substantially perpendicular to the direction in which light is emitted from the light source.

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