Systems and methods for monitoring plasma overcollection

Abstract

A method for collecting blood components from a subject using an automated blood collection system includes: separating plasma from whole blood received from the subject; initiating an alert when the predicted cumulative volume loss is greater than a configured removal level, the predicted cumulative volume loss depending on a cumulative volume comprising the separated plasma volume, the configured removal level defined by a pre-selected maximum value or a low blood volume level for the subject; and in response to feedback and alerts from an operator of the automated blood collection system, ending the process of collection, continuing collection, or initiating separation of platelets and erythrocytes.

Description

Cross Reference to Related Applications

[0001] This application claims priority to U.S. Patent Application No. 18 / 217,151, filed June 30, 2023. The entire disclosure of the above application is incorporated herein by reference. TECHNICAL FIELD

[0002] The present disclosure relates to systems and methods for monitoring overcollection during blood component collection. BACKGROUND

[0003] This section provides background information related to the present disclosure and can not necessarily be prior art.

[0004] Blood collection systems for collecting blood from healthy blood donors for subsequent use in emergency and / or medical and / or therapeutic uses are generally divided into two broad categories: manual blood collection systems and automated blood collection systems. Manual blood collection systems are, for example, those blood collection systems typically seen and used in community blood donation events, where blood from a healthy blood donor is collected by gravity flow into one or more blood collection containers, which is subsequently separated into one or more components, such as red blood cells, plasma, and / or platelets (using, for example, a centrifuge system), which are then used for emergency and / or medical and / or therapeutic uses. Automated blood collection systems, however, use specialized machines to separate the collected blood into one or more components as the blood is being collected from the blood donor. In certain variations, the automated blood collection systems can push unselected components of the one or more components back to the blood donor.

[0005] Generally, automated blood collection systems include predictive functionality software or programs that use received and / or collected information related to the donor to determine appropriate flow rates and volumes, whereby the resulting end product should be within the limits of volume, concentration, and final cell count for the individual donor as determined by government and / or blood center regulations and guidelines. Automated blood collection systems are also generally configured to use real-time data to continuously monitor and adjust the collection process to maintain acceptable donation levels, often referred to as low blood volume limits. For example, when one or more pumps, particularly the plasma pump, are not properly loaded, more volume can enter the collection bag due to positive pressure from the centrifuge than what the particular automated blood collection system believes it has pumped. In response to such a situation, the automated blood collection system is generally configured to monitor the draw volume and return volume in the return reservoir and accumulate the difference over time, apply the accumulated volume to a preselected level, such as a low blood volume limit, set by government and / or blood center regulations and guidelines, and issue an alert, in some cases terminate the donation, to ensure that the failure mode does not result in an unsafe condition for the donor. However, with this configuration, false alerts can occur, i.e., when the one or more pumps are checked, the pumps are actually properly loaded. Thus, it can be desirable to develop systems and methods of using the systems that can more accurately monitor real-time volume. SUMMARY

[0006] This section provides a general summary of the disclosure, and is not a comprehensive disclosure of the full scope or all the features of the disclosure.

[0007] In at least one example embodiment, the disclosure provides a method for collecting a blood component from a subject using an automated blood collection system. The method can include separating plasma from whole blood received from the subject; initiating an alert when a predicted cumulative volume loss is greater than a configured removal level, the predicted cumulative volume loss dependent on a cumulative volume including a volume of the separated plasma, the configured removal level defined by a maximum value or a low blood volume level preselected for the subject; and in response to feedback from an operator of the automated blood collection system and the alert, ending the process of collection, continuing collection, or initiating separation of platelets and red blood cells.

[0008] In at least one example embodiment, the method can also include determining the predicted cumulative volume loss. The predicted cumulative volume loss can be determined by summing a current predicted platelet volume less a predicted anticoagulant volume in the platelets, a current predicted plasma volume less a predicted anticoagulant volume in the plasma, a current predicted red blood cell volume less a predicted anticoagulant volume in the red blood cell product, and a cumulative volume detected by a reservoir monitor.

[0009] In at least one exemplary embodiment, the method may further include determining the configured removal level by multiplying a pre-selected maximum or low blood volume level for the subject by a volume precision offset value.

[0010] In at least one exemplary embodiment, the volume precision offset value may be greater than or equal to about 1.02 to less than or equal to about 1.1.

[0011] In at least one exemplary embodiment, the volume precision offset value can be 1.06.

[0012] In at least one exemplary embodiment, the end of the collection may include initiating a blood return flush.

[0013] In at least one exemplary embodiment, continued collection may include: continuing to separate plasma from whole blood received from the subject.

[0014] In at least one exemplary embodiment, during plasma separation, the method may further include comparing the sum of the actual collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume with a total blood volume limit.

[0015] In at least one exemplary embodiment, the method may further include initiating platelet and red blood cell separation when the sum of the actual collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume is greater than the total blood volume limit.

[0016] In at least one exemplary embodiment, when the sum of the actual plasma volume collected, the currently predicted platelet volume, and the currently predicted red blood cell volume is less than the total blood volume limit, the method may further include continuing to separate plasma from whole blood received from the subject.

[0017] In at least one exemplary embodiment, the total blood volume limit may be 15% of the total blood volume calculated for an individual subject.

[0018] In at least one exemplary embodiment, the total blood volume limit may be multiplied by a volume precision offset value before comparing the total blood volume limit with the sum of the actual collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume.

[0019] In at least one exemplary embodiment, the volume precision offset value may be greater than or equal to about 1.02 to less than or equal to about 1.1.

[0020] In at least one exemplary embodiment, after initiating the collection of platelets and red blood cells, the method may further include initiating a backflow flush.

[0021] In at least one exemplary embodiment, this disclosure provides a method for collecting blood components from a subject using an automated blood collection system. The method may include: separating plasma from whole blood received from the subject; comparing a predicted cumulative volume loss with a configured removal level, the predicted cumulative volume loss depending on a cumulative volume including the volume of plasma separated, the configured removal level being defined by a pre-selected maximum or low blood volume level for the subject; and generating an alarm for a user of the automated blood collection system if the predicted cumulative volume loss is greater than the configured removal level, the alarm including at least three prompts, wherein a first prompt of the at least three prompts may include ending the collection process in response to the alarm, a second prompt of the at least three prompts may include continuing to separate plasma from whole blood while bypassing the alarm, and a third prompt of the at least three prompts may include ending the plasma collection phase and initiating a platelet collection phase, a red blood cell collection phase, or a combination of a platelet collection phase and a red blood cell collection phase.

[0022] In at least one exemplary embodiment, the method may further include determining a predicted cumulative volume loss and determining a configured removal level. The predicted cumulative volume loss may be determined by summing the currently predicted platelet volume excluding the predicted anticoagulant volume in platelets, the currently predicted plasma volume excluding the predicted anticoagulant volume in plasma, the currently predicted red blood cell volume excluding the predicted anticoagulant volume in red blood cell products, and the cumulative volume detected by a reservoir monitor. The configured removal level may be determined by multiplying a pre-selected maximum value or low blood volume level for the subject by a volume accuracy offset value.

[0023] In at least one exemplary embodiment, when bypassing the alarm, the method may further include: comparing the sum of the actual collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume with a total blood volume limit.

[0024] In at least one exemplary embodiment, platelet and red blood cell collection may be initiated when the sum of the actual collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume is greater than the total blood volume limit, and the method may further include continuing to separate plasma from whole blood when the sum of the actual collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume is less than the total blood volume limit.

[0025] In at least one exemplary embodiment, the total blood volume limit may be 15% of the total blood volume calculated for an individual subject.

[0026] In at least one exemplary embodiment, the total blood volume limit may be multiplied by a volume precision offset value before comparing the total blood volume limit with the sum of the actual collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume.

[0027] Further applicable areas will become apparent from the description provided herein. The descriptions and specific examples in this overview are intended for illustrative purposes only and are not intended to limit the scope of this disclosure. Attached Figure Description

[0028] The accompanying drawings described herein are for illustrative purposes only of the selected embodiments and do not represent all possible implementations, nor are they intended to limit the scope of this disclosure.

[0029] Figure 1 This is a flowchart illustrating an exemplary method for monitoring and maintaining a safe volume level when using an automated blood collection system, according to at least one exemplary embodiment of the present disclosure; Figure 2 An exemplary alarm may appear on the user interface of an automated blood collection system when the predicted cumulative volume loss is greater than or equal to the product of the volume accuracy offset value and the configured removal level, according to at least one exemplary embodiment of this disclosure; and Figure 3 An exemplary alarm may appear on the user interface of an automated blood collection system when the possible amount of collected plasma remains high and the plasma collection phase has ended, according to at least one exemplary embodiment of this disclosure.

[0030] In several views of the accompanying drawings, corresponding reference numerals indicate the corresponding parts. Detailed Implementation

[0031] Exemplary embodiments will now be described more fully with reference to the accompanying drawings.

[0032] Exemplary embodiments are provided so that this disclosure will be thorough and will fully convey the scope to those skilled in the art. Numerous specific details, such as examples of specific components, devices, and methods, are set forth to provide a thorough understanding of embodiments of this disclosure. It will be apparent to those skilled in the art that these specific details are not required, that exemplary embodiments may be implemented in many different forms, and that embodiments should not be construed as limiting the scope of this disclosure. In some exemplary embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.

[0033] The terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. As used herein, the singular forms “a,” “an,” and “the” are intended to also include the plural forms unless the context clearly indicates otherwise. The terms “comprising,” “including,” “containing,” and “having” are inclusive and thus indicate the presence of the described features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. The method steps, processes, and operations described herein should not be construed as requiring them to be performed in the particular order discussed or shown, unless specifically identified as such. It should also be understood that additional or alternative steps may be employed.

[0034] When an element or layer is said to be located “on”, “joined to”, “connected to”, or “coupled to” another element or layer, this element or layer may be directly located on, joined to, or coupled to the other element or layer, or there may be intermediate elements or layers present. Conversely, when an element is said to be located “directly” on, joined to, connected to, or coupled to another element or layer, there may be no intermediate elements or layers present. Other terms used to describe relationships between elements should be interpreted in a similar manner (e.g., “located between” versus “directly located between”, “adjacent” versus “directly adjacent”, etc.). As used herein, the term “and / or” includes any and all combinations of one or more of the associated items listed.

[0035] While the terms first, second, third, etc., may be used herein to describe various elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. When terms such as “first,” “second,” and other numerical terms are used herein, these terms do not imply order or sequence unless the context clearly indicates otherwise. Therefore, without departing from the teachings of exemplary embodiments, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment.

[0036] For ease of description, spatial relative terms such as “inside,” “outside,” “below,” “under,” “below,” “above,” and “above” are used herein to describe the relationship between one element or feature and another element or feature as shown in the figure. In addition to covering the orientation depicted in the figure, spatial relative terms may also be intended to cover different orientations of the device during use or operation. For example, if the device in the figure is flipped over, an element described as being “below” or “below” other elements or features may be oriented to be “above” other elements or features. Thus, the exemplary term “below” can cover both upper and lower orientations. The device may be oriented in other ways (rotated 90 degrees or in other orientations), and the spatial relative descriptors used herein shall be interpreted accordingly.

[0037] Various components are referred to herein as “operably associated.” As used herein, “operably associated” means components that are operably connected together, and covers embodiments in which components are directly connected, as well as embodiments in which additional components are placed between connected components. “Operably associated” components can be “fluidly associated.” “Fluidally associated” means that components are connected together such that fluid can be transported between the components. “Fluidally associated” covers embodiments in which additional components are placed between two fluidly associated components and between directly connected components. Fluidly associated components may include components that do not contact the fluid but contact other components to manipulate a system (e.g., a peristaltic pump that pumps fluid through a flexible tube outside a compression tube).

[0038] In this application, including the definitions below, the terms "module" or "controller" may be replaced by the term "circuit". The term "module" may refer to, or may be part of, or may include: application-specific integrated circuits (ASICs); digital, analog, or mixed-signal analog / digital discrete circuits; digital, analog, or mixed-signal analog / digital integrated circuits; combinational logic circuits; field-programmable gate arrays (FPGAs); processor circuitry that runs code (shared processor circuitry, dedicated processor circuitry, or a group of processor circuitry); memory circuitry that stores code executed by the processor circuitry (shared memory circuitry, dedicated memory circuitry, or a group of memory circuitry); other suitable hardware components that provide the described functionality; or combinations of some or all of the foregoing, such as in a system-on-a-chip.

[0039] A module may include one or more interface circuits. In some exemplary embodiments, the interface circuit may include a wired or wireless interface connected to a local area network (LAN), the Internet, a wide area network (WAN), or a combination thereof. The functionality of any given module of this disclosure may be distributed among multiple modules connected via interface circuits. For example, multiple modules may allow load balancing. In another example, a server module (also referred to as a remote module or cloud module) may perform some functions on behalf of a client module.

[0040] The term "code," as used above, can include software, firmware, and / or microcode, and can refer to programs, routines, functions, classes, data structures, and / or objects. The term "shared processor circuitry" encompasses a single processor circuitry that runs some or all of the code from multiple modules. The term "group of processor circuitry" encompasses processor circuitry combined with additional processor circuitry to run some or all of the code from one or more modules. References to multiple processor circuitry encompass multiple processor circuitry on a discrete die, multiple processor circuitry on a single die, multiple cores of a single processor circuitry, multiple threads of a single processor circuitry, or a combination of the above. The term "shared memory circuitry" encompasses a single memory circuitry that stores some or all of the code from multiple modules. The term "group of memory circuitry" encompasses memory circuitry combined with additional memory to store some or all of the code from one or more modules.

[0041] The term memory circuit is a subset of the term computer-readable medium. As used herein, the term computer-readable medium does not cover transient electrical or electromagnetic signals propagating through a medium (e.g., propagating on a carrier wave); therefore, the term computer-readable medium can be considered tangible and non-transitory. Non-limiting examples of non-transitory, tangible computer-readable media are non-volatile memory circuits (e.g., flash memory circuits, erasable programmable read-only memory circuits, or masked read-only memory circuits), volatile memory circuits (e.g., static random access memory circuits or dynamic random access memory circuits), magnetic storage media (e.g., analog or digital magnetic tape or hard disk drives), and optical storage media (e.g., CDs, DVDs, or Blu-ray discs).

[0042] The apparatus and methods described in this application can be implemented, in part or in whole, by a dedicated computer, which is created by configuring a general-purpose computer to perform one or more specific functions embodied in a computer program. The aforementioned functional blocks, flowchart components, and other elements serve as software specifications that can be translated into computer programs by skilled technicians or programmers through their daily work.

[0043] A computer program includes processor-executable instructions stored on at least one non-transitory, tangible, computer-readable medium. A computer program may also include stored data or depend on stored data. A computer program may encompass a basic input / output system (BIOS) for interacting with the hardware of a special-purpose computer, device drivers for interacting with specific devices of the special-purpose computer, one or more operating systems, user applications, background services, background applications, etc.

[0044] Computer programs may include: (i) descriptive text to be parsed, such as HTML (Hypertext Markup Language), XML (Extensible Markup Language), or JSON (JavaScript Object Notation); (ii) assembly code; (iii) object code generated from source code by a compiler; (iv) source code run by an interpreter; (v) source code compiled and run by a just-in-time (JIT) compiler; and so on. As an example only, source code may be written using syntax from a variety of languages, including C, C++, C#, Objective-C, Swift, Haskell, Go, SQL, R, Lisp, Java®, Fortran, Perl, Pascal, Curl, OCaml, JavaScript®, HTML5 (Hypertext Markup Language version 5), Ada, ASP (Active Server Pages), PHP (PHP: Hypertext Preprocessor), Scala, Eiffel, Smalltalk, Erlang, Ruby, Flash®, Visual Basic®, Lua, MATLAB, SIMULINK, and Python®.

[0045] Exemplary embodiments will now be described more fully with reference to the accompanying drawings.

[0046] This disclosure relates to methods and apparatus for monitoring the collection of one or more blood components (such as platelets, red blood cells, and plasma) using an automated blood collection system, such as the blood collection system described in U.S. Patent No. 10,585,085, entitled "Collecting Components of a Fluid," published March 10, 2020, and / or the blood collection system described in U.S. Patent No. 9,758,764, entitled "Separating a Complex Liquid," published September 12, 2017, and / or the blood collection system described in U.S. Patent No. 10,618,060, entitled "Centrifuge Safety Mechanism," published April 14, 2020, and / or the blood collection system described in U.S. Patent No. 10,166,322, entitled "Gain in a Separation Process with a Control Loop," published January 1, 2019, and / or the blood collection system described in U.S. Patent No. 2019, entitled "Gain in a Separation Process with a Control Loop," ... The blood collection system described in U.S. Patent No. 9,440,011, entitled “Mixed Blood Component Storage Bag and Method of Manufacturing Such Bag”, published September 13, 2016, and / or the blood collection system described in U.S. Patent No. 8,523,750, entitled “Method and Apparatus for Extracting Platelets in a Manner with Reduced Plasma Carrying”, published September 3, 2013, and / or the blood collection system described in U.S. Patent No. 8,123,713, entitled “System and Method for Collecting Plasma Protein Components from Separated Blood Components”, published February 28, 2012, and / or the blood collection system described in U.S. Patent No. 7,780,618, entitled “Extracorporeal Blood Processing Apparatus and Method Utilizing Pressure Sensing”, published August 24, 2010, the entire disclosure of these U.S. Patents is incorporated herein by reference. Typically, the methods for using automated blood collection systems generally involve: collecting whole blood from the donor, separating the whole blood into one or more selected components (such as platelets, red blood cells, and plasma), and returning the unselected components (such as white blood cells) to the donor.

[0047] Figure 1 An exemplary method 100 is shown for monitoring the volume or amount of plasma collected and maintaining it within a pre-selected level (e.g., low blood volume restriction). This pre-selected level is set, for example, by government and / or blood center regulations and guidelines, and is referred to as the “configured removal level”, for example, when using an exemplary automated blood collection system. The configured removal level is a donor-specific, safe amount or volume of selected blood components to be collected from the donor or subject, and can be determined using information entered or stored by the user or operator or donor (e.g., sex, height, weight, hematocrit, and / or platelet count) and measurements from ongoing collection (e.g., inlet volume and / or blood volume collected to date).

[0048] Method 100 may include initiating a plasma collection aspiration cycle, which includes completing one or more cycles or sequences or stages to separate, collect, remove, or extract 110 or more volumes or amounts of plasma from whole blood collected or received from a donor. One or more centrifuge systems of an automated blood collection system may be used to separate, collect, remove, or extract 110 plasma from whole blood. During plasma separation, collection, removal, or extraction, method 100 may include determining 120 whether a predicted cumulative volume loss or predicted cumulative amount loss for the donor or subject is greater than a configured removal level. In at least one exemplary embodiment, determining 120 may include monitoring the amount or volume pumped into and out of the reservoir and determining whether the difference between these two amounts or volumes is greater than a predetermined or normal threshold (e.g., about 7 ml). If the difference is greater than the predetermined or normal threshold, a potential failure of pump loading may be assumed, and method 100 may continue to method step 125. However, if the difference is less than a predetermined or normal threshold, no potential failure of the pump loading is assumed, and method 100 may continue to perform plasma separation or collection or removal or extraction (i.e., method step 110).

[0049] In at least one exemplary embodiment, the configured removal level may be multiplied by a volumetric accuracy offset value before comparing the configured removal level with the predicted cumulative volumetric loss. In some cases, the product of the configured removal level and the volumetric accuracy offset value may be referred to as the corrected configured removal level and / or the adjusted configured removal level. The volumetric accuracy offset value may help to take any volumetric offset into account. In at least one exemplary embodiment, the volumetric accuracy offset value may be greater than or equal to about 1.02 to less than or equal to about 1.1, and in some aspects, optionally 1.06. If the predicted cumulative volumetric loss is greater than or equal to the corrected configured removal level, method 100 may proceed to method step 125. If the predicted cumulative volumetric loss is less than the corrected configured removal level, method 100 may continue with plasma separation or collection or removal or extraction (i.e., method step 110).

[0050] Although not shown, it should be appreciated that in at least one exemplary embodiment, method 100 may further include determining a predicted cumulative volume loss, which may also be referred to as the volume or amount to be removed. Calculating the predicted cumulative volume loss may be an iterative process that includes incorporating real-time data. For example, in at least one exemplary embodiment, the predicted cumulative volume loss may be equal to: the currently predicted platelet volume excluding the predicted anticoagulant (AC) volume in platelets, the currently predicted plasma volume excluding the predicted anticoagulant volume in plasma, the currently predicted red blood cell volume excluding the predicted anticoagulant volume in red blood cell products, and the sum of the volume accumulated toward the reservoir shut-off monitor. More simply, the predicted cumulative volume loss = (currently predicted platelet volume - predicted anticoagulant volume in platelets) + (currently predicted plasma volume - predicted anticoagulant volume in plasma) + (currently predicted red blood cell volume - predicted anticoagulant volume in red blood cell products) + the volume accumulated toward the reservoir shut-off monitor.

[0051] Although not shown, it should be appreciated that in at least one exemplary embodiment, method 100 may further include at least one of the following: determining the currently predicted platelet volume, determining the predicted anticoagulant volume in the platelets, determining the currently predicted plasma volume, determining the predicted anticoagulant volume in the plasma, determining the currently predicted red blood cell volume, determining the predicted anticoagulant volume in the red blood cell product, and determining the volume accumulated toward the reservoir shut-off monitor. In at least one exemplary embodiment, the volume accumulated toward the reservoir shut-off monitor may be the difference between the amount or volume pumped into the reservoir and the amount or volume pumped out of the reservoir, as described above.

[0052] Refer again Figure 1 If the predicted cumulative volume loss is greater than or equal to (corrected) the configured removal level, method 100 may include generating, sending, or initiating a warning or alarm (e.g., to the user or graphical interface or screen of the automated blood collection system) Figure 2 (As shown in the image) and / or stop one or more pumps in the automated blood collection system, thereby stopping plasma collection. The user interface may also include a flag indicating that the collected plasma may be contaminated (e.g., contaminated with white blood cells). Figure 2 As shown, alerts pushed to the user interface can include one or more prompts. For example, using the user interface, a user or operator of the blood collection system can choose to end or continue collection or proceed to a new patient procedure after an investigation. For example, as... Figure 1As shown, if the user or operator chooses to continue collecting, method 100 can proceed to method step 130; if the user or operator enters a new program, method 100 can proceed to method step 150; and if the user or operator chooses to terminate the operation, method 100 can proceed to method step 160.

[0053] Depending on the user's or operator's choice, method 100 may include continuing plasma separation or collection or removal or extraction at method step 130. During the ongoing or continuing plasma separation or collection or removal or extraction, method 100 may include determining whether the sum of the actual plasma volume collected at 140, the currently predicted platelet volume, and the currently predicted red blood cell volume is greater than or equal to a total blood volume limit, or in some cases is close to a total blood volume limit. In at least one exemplary embodiment, the total blood volume limit may be a hard limit of 15% of the total blood volume calculated for an individual blood donor.

[0054] In at least one exemplary embodiment, the total blood volume limit may be multiplied by a volume precision offset value before the total blood volume limit is compared with the sum of the actual collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume. This occurs before the total blood volume limit is compared with the sum of the actual collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume to take any volume offset into account. The volume precision offset value used to adjust the total blood volume limit may be the same as or different from the volume precision offset value used to adjust the configured removal level. For example, in at least one exemplary embodiment, the volume precision offset value used to adjust the total blood volume limit may be greater than or equal to about 1.02 to less than or equal to about 1.1, and in some aspects, optionally 1.06. In some cases, the product of the total blood volume limit and the volume precision offset value may be referred to as the corrected or adjusted total blood volume limit.

[0055] If the sum of the actual collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume is less than the (corrected) total blood volume limit, method 100 may continue with plasma separation, collection, removal, or extraction (i.e., method step 130). If the sum of the actual collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume is greater than or equal to the (corrected) total blood volume limit, method 100 may continue to method step 145, where method 100 includes ending plasma collection and displaying another or second alarm related to plasma separation, collection, removal, or extraction on the user interface of the automated blood collection system (e.g., such as...). Figure 3 As shown). Figure 3As shown, another alert may include a message that the system continues to detect that the plasma volume may be too high and that plasma collection has ended. Another alert may include a prompt instructing the user or operator to select the prompt to start or continue collecting other blood products, such as platelets and red blood cells. The user interface may also include a symbol that appears when another alert is displayed indicating that the collected plasma may be contaminated (e.g., contaminated with white blood cells).

[0056] Refer again Figure 1 Method 100 may include completing one or more cycles or sequences or stages in response to a sum of the actual collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume being greater than or equal to a (corrected) total blood volume limit, or in response to an action by a user or operator at 145 of method step 120, to separate or collect or remove or extract 150 or more platelet volumes and / or one or more red blood cell volumes from whole blood collected or received from a donor. One or more quantities of platelets and / or one or more quantities of red blood cells may be separated or collected or removed or extracted from whole blood available after removing one or more quantities of plasma using one or more centrifuge systems of an automated blood collection system. After collecting platelets and / or red blood cells, method 100 may include displaying a screen on a user interface at 170 indicating collection completion, followed by initiating a backwash at 180, during which uncollected blood components and / or excess material are returned or pushed back to the donor. Once a backwash has occurred, method 100 may include displaying a notification on the user interface at 190 indicating end of operation and ending the collection.

[0057] If the user or operator chooses to terminate the run when the initial alarm is displayed, method 100 may include a decision point 160, at which the user or operator determines to initiate or bypass the backflush. If the user or operator determines to initiate the backflush, method 100 may proceed to 180. However, if the user or operator determines to bypass the backflush, method 100 may include displaying a notification to terminate the run on the user interface at 190 and ending the collection.

[0058] This configuration allows collection to continue beyond the plasma alarm level until a pre-selected upper limit level (e.g., low blood volume limit) is set by government and / or blood center regulations and guidelines. Platelet and red blood cell collection is allowed to run until completion because the prediction is used for plasma logic, giving the user or operator the option to select a lower volume procedure as needed, and using the actual volume collected into the plasma collection bag of the automated blood collection system (rather than the predicted volume at the end of the run) to allow the user or operator to collect the available volume in most cases.

[0059] The foregoing description of embodiments has been provided for purposes of illustration and description. The embodiments are not intended to be exhaustive or limiting of this disclosure. Various elements or features of a particular embodiment are generally not limited to that particular embodiment, but are interchangeable where applicable, and may be used in chosen embodiments even if not specifically shown or described. Embodiments may also be varied in many ways. Such variations should not be considered a departure from this disclosure, but all such modifications are intended to be included within the scope of this disclosure.

Claims

1. A method for collecting blood components from a subject using an automated blood collection system, the method comprising: separating plasma from whole blood received from the subject; initiating an alert when a predicted cumulative volume loss is greater than a configured removal level, the predicted cumulative volume loss depending on a cumulative volume comprising a volume of separated plasma, the configured removal level defined by a maximum value or a hypovolemia level preselected for the subject; and ending a process of the collection, continuing the collection, or initiating separation of platelets and red blood cells in response to feedback from an operator of the automated blood collection system and the alert.

2. The method of claim 1, wherein, the method further comprising determining the predicted cumulative volume loss by summing a current predicted platelet volume less a predicted anticoagulant volume in the platelets, a current predicted plasma volume less a predicted anticoagulant volume in the plasma, a current predicted red blood cell volume less a predicted anticoagulant volume in the red blood cell product, and a cumulative volume detected by a reservoir monitor.

3. The method of claim 1, wherein, the method further comprising determining the configured removal level by multiplying the maximum value or the hypovolemia level preselected for the subject by a volume accuracy offset value.

4. The method of claim 3, wherein, the volume accuracy offset value is greater than or equal to about 1.02 to less than or equal to about 1.

1.

5. The method of claim 4, wherein, the volume accuracy offset value is 1.

06.

6. The method of claim 1, wherein, the ending of the collection comprises initiating a reinfusion.

7. The method of claim 1, wherein, the continuing of the collection comprises continuing to separate plasma from whole blood received from the subject.

8. The method of claim 7, wherein, the method further comprises comparing a sum of a collected actual plasma volume, a current predicted platelet volume, and a current predicted red blood cell volume to a total blood volume limit during the separation of the plasma.

9. The method of claim 8, wherein, the method further comprises initiating separation of platelets and red blood cells when the sum of the collected actual plasma volume, the current predicted platelet volume, and the current predicted red blood cell volume is greater than the total blood volume limit.

10. The method of claim 8, wherein, the method further comprises continuing to separate plasma from whole blood received from the subject when the sum of the collected actual plasma volume, the current predicted platelet volume, and the current predicted red blood cell volume is less than the total blood volume limit.

11. The method of claim 8, wherein, the total blood volume limit is 15% of a total blood volume calculated for an individual subject.

12. The method of claim 8, wherein, the total blood volume limit is multiplied by a volume accuracy offset value prior to comparing the total blood volume limit to the sum of the collected actual plasma volume, the current predicted platelet volume, and the current predicted red blood cell volume.

13. The method of claim 12, wherein, the volume accuracy offset value is greater than or equal to about 1.02 to less than or equal to about 1.

1.

14. The method of claim 1, wherein, the method further comprises initiating a reinfusion after initiating the collection of the platelets and red blood cells.

15. A method for collecting blood components from a subject using an automated blood collection system, the method comprising: separating plasma from whole blood received from the subject; comparing the predicted cumulative volume loss to a configured removal level, the predicted cumulative volume loss depending on a cumulative volume including a volume of separated plasma, the configured removal level defined by a maximum value or a hypovolemia level preselected for the subject; and generating an alert to a user of the automated blood collection system if the predicted cumulative volume loss is greater than the configured removal level, the alert including at least three prompts, a first prompt of the at least three prompts including a procedure to end the collection in response to the alert, a second prompt of the at least three prompts including continuing to separate the plasma from the whole blood despite the alert, and a third prompt of the at least three prompts including ending a plasma collection phase and initiating a platelet collection phase, a red blood cell collection phase, or a combination of a platelet collection phase and a red blood cell collection phase.

16. The method of claim 15, wherein, The method further includes: determining the predicted cumulative volume loss by summing a current predicted platelet volume less a predicted anticoagulant volume in the platelets, a current predicted plasma volume less a predicted anticoagulant volume in the plasma, a current predicted red blood cell volume less a predicted anticoagulant volume in the red blood cell product, and a cumulative volume detected by a reservoir monitor; and determining the configured removal level by multiplying a maximum value or a hypovolemia level preselected for the subject by a volume accuracy offset value.

17. The method of claim 15, wherein, When bypassing the alert, the method further includes comparing a sum of a collected actual plasma volume, a current predicted platelet volume, and a current predicted red blood cell volume to a total blood volume limit.

18. The method of claim 17, wherein, When the sum of the collected actual plasma volume, the current predicted platelet volume, and the current predicted red blood cell volume is greater than the total blood volume limit, initiating collection of platelets and red blood cells, and when the sum of the collected actual plasma volume, the current predicted platelet volume, and the current predicted red blood cell volume is less than the total blood volume limit, continuing to separate the plasma from the whole blood.

19. The method of claim 17, wherein, The total blood volume limit is 15% of a total blood volume calculated for the individual subject.

20. The method of claim 17, wherein, The total blood volume limit is multiplied by a volume accuracy offset value prior to comparing the total blood volume limit to the sum of the collected actual plasma volume, the current predicted platelet volume, and the current predicted red blood cell volume. The method further includes: determining the predicted cumulative volume loss by summing a current predicted platelet volume less a predicted anticoagulant volume in the platelets, a current predicted plasma volume less a predicted anticoagulant volume in the plasma, a current predicted red blood cell volume less a predicted anticoagulant volume in the red blood cell product, and a cumulative volume detected by a reservoir monitor; and determining the configured removal level by multiplying a maximum value or a hypovolemia level preselected for the subject by a volume accuracy offset value. When bypassing the alert, the method further includes comparing a sum of a collected actual plasma volume, a current predicted platelet volume, and a current predicted red blood cell volume to a total blood volume limit. When the sum of the collected actual plasma volume, the current predicted platelet volume, and the current predicted red blood cell volume is greater than the total blood volume limit, initiating collection of platelets and red blood cells, and when the sum of the collected actual plasma volume, the current predicted platelet volume, and the current predicted red blood cell volume is less than the total blood volume limit, continuing to separate the plasma from the whole blood. The total blood volume limit is 15% of a total blood volume calculated for the individual subject. The total blood volume limit is multiplied by a volume accuracy offset value prior to comparing the total blood volume limit to the sum of the collected actual plasma volume, the current predicted platelet volume, and the current predicted red blood cell volume.

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