System and method for monitoring plasma over-collection

Abstract

A method for collecting blood components from a subject using an automated blood collection system includes the steps of: separating plasma from whole blood received from the subject; initiating an alarm when the predicted cumulative volume loss is greater than a set extraction level, wherein the predicted cumulative volume loss is determined by the cumulative volume including the volume of the separated plasma, and the set extraction level is defined by the level of circulating blood volume reduction for the subject or a pre-selected maximum value; and terminating the blood component collection process, continuing the collection process, or initiating the separation of platelets and red blood cells in response to the alarm and feedback from the operator of the automated blood collection system.

Description

Technical Field

[0001] (Cross - reference to related applications) This application claims the priority of U.S. Patent Application No. ********** (filed on June 30, 2023). The entire disclosure of the above application is incorporated herein by reference.

[0002] This disclosure relates to systems and methods for monitoring over - collection in blood component collection.

Background Art

[0003] This section provides background information related to this disclosure which is not necessarily prior art.

[0004] Blood collection systems for collecting blood from healthy donors for emergencies and / or medical procedures and / or therapeutic uses are generally classified into two major categories: manual blood collection systems and automated blood collection systems. Manual blood collection systems are commonly seen and used, for example, at blood donation sites such as local governments. In this case, blood from a healthy donor is collected into one or more blood collection containers using gravity and then separated into one or more components such as red blood cells, plasma, and / or platelets (e.g., using a centrifugation system) and used for emergencies and / or medical procedures and / or therapeutic uses. However, in an automated blood collection system, a dedicated device is used to separate the collected blood into one or more components while collecting blood from the donor. In some cases, the automated blood collection system returns unselected components of one or more components to the donor.

[0005] Note: The number in the priority claim in the translation is replaced with ********** as the original number is not provided completely in the question.In many cases, automated blood collection systems have predictive software or programs that use received and / or collected information about the donor to determine appropriate flow rates and volumes so that the final product can be obtained that is within the range of volume, concentration, and final cell count for the individual donor as determined by the regulations and guidelines of government agencies and / or blood centers. Automated blood collection systems are also often configured to continuously monitor and adjust the collection process using real-time data to maintain an acceptable level of blood collection (usually called the circulating blood volume reduction limit). For example, if one or more pumps (especially plasma pumps) are not properly loaded, more blood may end up in the collection bag than a particular automated blood collection system expects to pump due to positive pressure from the centrifuge. To address such situations, automated blood collection systems are often configured to monitor the draw-in and return volumes in a return reservoir container, accumulate the difference between these volumes over time, apply the accumulated volume (cumulative volume) to a pre-selected level (e.g., a circulating blood volume reduction limit) set, for example, by the regulations and guidelines of government agencies and / or blood centers, generate an alarm (and, in some cases, terminate blood collection), and ensure that equipment malfunctions do not lead to a dangerous situation for the donor. [Overview of the project] [Problems that the invention aims to solve]

[0006] However, this configuration can lead to false alarms, specifically when one or more pumps are being inspected while the pumps are actually properly loaded. Therefore, there is a need to develop a system and method for using it that can more accurately monitor the volume in real time.

[0007] This section provides a general overview of the disclosure and does not constitute a comprehensive disclosure of its entire scope or all features. [Means for solving the problem]

[0008] In at least one exemplary embodiment, the Disclosure provides a method for collecting blood components from a subject using an automated blood collection system. The method includes the steps of: separating plasma from whole blood received from the subject; initiating an alarm if the predicted cumulative volume loss is greater than a set extraction level, wherein the predicted cumulative volume loss is determined by the cumulative volume including the volume of the separated plasma, and the set extraction level is defined by the level of circulating blood volume reduction for the subject or a pre-selected maximum value; and, in response to the alarm and feedback from the operator of the automated blood collection system, terminating the blood component collection process, continuing the collection process, or initiating the separation of platelets from red blood cells.

[0009] In at least one exemplary embodiment, the method may further include the step of determining the predicted cumulative volume loss. The predicted cumulative volume loss may be determined by summing the volume obtained by subtracting the volume of the predicted anticoagulant in the platelets from the current predicted volume of platelets, the volume obtained by subtracting the volume of the predicted anticoagulant in the plasma from the current predicted volume of plasma, the volume obtained by subtracting the volume of the predicted anticoagulant in the red blood cells from the current predicted volume of red blood cells, and the cumulative volume detected by a reservoir vessel monitor.

[0010] In at least one exemplary embodiment, the method may further include the step of determining the extraction level setting value by multiplying the circulating blood volume reduction level or the pre-selected maximum value for the subject by a volumetric accuracy offset value.

[0011] In at least one exemplary embodiment, the volumetric accuracy offset value may be between approximately 1.02 and approximately 1.1.

[0012] In at least one exemplary embodiment, the volumetric accuracy offset value may be 1.06.

[0013] In at least one exemplary embodiment, terminating the sampling process may include initiating a rinse-back.

[0014] In at least one exemplary embodiment, continuing the collection process may include continuing to separate plasma from the whole blood received from the subject.

[0015] In at least one exemplary embodiment, the method may further include the step of comparing the sum of the actual volume of plasma collected, the currently predicted volume of platelets, and the currently predicted volume of red blood cells during the separation of the plasma to the total blood volume limit.

[0016] In at least one exemplary embodiment, the method may further include the step of initiating the separation of platelets and red blood cells if the sum of the volume of actual plasma collected, the currently predicted volume of platelets, and the currently predicted volume of red blood cells is greater than the total blood volume limit.

[0017] In at least one exemplary embodiment, the method may further include the step of continuing to separate plasma from the whole blood received from the subject if the sum of the volume of the actual plasma collected, the currently predicted volume of platelets, and the currently predicted volume of red blood cells is less than the total blood volume limit.

[0018] In at least one exemplary embodiment, the total blood volume limit may be 15% of the total blood volume calculated for the subject.

[0019] In at least one exemplary embodiment, the total blood volume limit may be multiplied by a volume accuracy offset value, and the multiplied total blood volume limit may be compared with the sum of the volume of the actual plasma collected, the currently predicted volume of platelets, and the currently predicted volume of red blood cells.

[0020] In at least one exemplary embodiment, the volumetric accuracy offset value may be between approximately 1.02 and approximately 1.1.

[0021] In at least one exemplary embodiment, the method may further include a step of initiating a rinse-back after initiating the collection of platelets and red blood cells.

[0022] In at least one exemplary embodiment, the present disclosure provides a method for collecting blood components from a subject using an automated blood collection system. The method includes the steps of: separating plasma from whole blood received from the subject; comparing a predicted cumulative volume loss with a set extraction level, wherein the predicted cumulative volume loss is determined by the cumulative volume including the volume of the separated plasma, and the set extraction level is defined by the level of circulating blood volume reduction for the subject or a pre-selected maximum value; and, if the predicted cumulative volume loss is greater than the set extraction level, generating an alarm for the user of the automated blood collection system, comprising at least three prompts, wherein the first of the at least three prompts includes terminating the collection process in response to the alarm; the second of the at least three prompts includes ignoring the alarm and continuing the separation of the plasma from the whole blood; and the third of the at least three prompts includes terminating the plasma collection stage and initiating a platelet collection stage, or an erythrocyte collection stage, or a combination of the platelet collection stage and the erythrocyte collection stage.

[0023] In at least one exemplary embodiment, the method may further include determining the predicted cumulative volume loss and determining the extraction level set value. The predicted cumulative volume loss may be determined by summing the volume obtained by subtracting the predicted volume of the anticoagulant in the platelets from the currently predicted volume of the platelets, the volume obtained by subtracting the predicted volume of the anticoagulant in the plasma from the currently predicted volume of the plasma, the volume obtained by subtracting the predicted volume of the anticoagulant in the red blood cells from the currently predicted volume of the red blood cells, and the accumulated volume detected by the reservoir container monitor. The extraction level set value may be determined by multiplying the circulating blood volume reduction level or the preselected maximum value for the subject by a volume accuracy offset value.

[0024] In at least one exemplary embodiment, the method may further include comparing the sum of the actually collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume with the total blood volume limit value when the alarm is ignored.

[0025] In at least one exemplary embodiment, when the sum of the actually collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume is greater than the total blood volume limit value, the collection of the platelets and the red blood cells is started, and when the sum of the actually collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume is less than the total blood volume limit value, the separation of the plasma from the whole blood may be continued.

[0026] In at least one exemplary embodiment, the total blood volume limit value may be 15% of the total blood volume calculated for the subject.

[0027] In at least one exemplary embodiment, the total blood volume limit value is multiplied by a volume accuracy offset value, and the multiplied total blood volume limit value may be compared with the sum of the volume of the actually collected plasma, the current predicted platelet volume, and the current predicted red blood cell volume.

[0028] Further applicable ranges will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.

[0029] The drawings herein are for purposes of illustration of selected embodiments only and are not intended to limit the scope of the present disclosure, which is not all possible implementations.

Brief Description of the Drawings

[0030] [Figure 1] FIG. 1 is a flowchart showing an exemplary method for monitoring volume levels 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] FIG. 2 shows an example of an alert that occurs 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 extraction level setting value, according to at least one exemplary embodiment of the present disclosure. [Figure 3] [[ID=​​​​​​​​​​​​

[0033] Exemplary embodiments are provided for the completeness of this disclosure and to fully convey its scope to those skilled in the art. Numerous specific details, such as examples of specific components, apparatus, and methods, are described in order to provide a full understanding of the embodiments of this disclosure. It will be apparent to those skilled in the art that specific details are not necessary, that the exemplary embodiments may be embodied in many different forms, and that none should be construed as limiting the scope of this disclosure. In some exemplary embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.

[0034] The terms used herein are intended to describe, and not limit, specific exemplary embodiments. Where used herein, the singular forms “a,” “an,” and “the” are intended to include the plural form unless the context clearly indicates otherwise. The terms “comprises,” “comprising,” “including,” and “having” are inclusive and thus specify the presence of the described features, entities, steps, actions, elements, and / or components, but do not exclude the presence or addition of one or more other features, entities, steps, actions, elements, components, and / or sets thereof. The steps, processes, and actions of the methods described herein should not necessarily be construed as requiring execution in a specific order described or illustrated unless specifically identified as the order of execution. It should also be understood that additional or alternative steps may be used.

[0035] When an element or layer is referred to as "on top of," "engaged to," "connected to," or "bonded to" another element or layer, it may be directly on, directly engaged to, directly connected to, or directly bonded to the other element or layer, or an intervening element or layer may exist. On the other hand, when an element is referred to as "directly on top of," "directly engaged to," "directly connected to," or "directly bonded to" another element or layer, there is no intervening element or layer. Other terms used to describe relationships between elements should be interpreted similarly (e.g., "between" vs. "directly between," "adjacent" vs. "directly adjacent," etc.). As used herein, the term "and / or" includes any and all combinations of one or more of the related enumerated items.

[0036] The terms "first," "second," "third," etc., may be used herein to describe various elements, components, regions, layers, and / or sections, but these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms are used solely to distinguish one element, component, region, layer, or part from other regions, other layers, or other parts. The terms "first," "second," etc., and other numerical terms, when used herein, do not imply order or sequence unless explicitly indicated by the context. Accordingly, the first element, first component, first region, first layer, or first section described below may also be called the second element, second component, second region, second layer, or second section, without departing from the teaching of the exemplary embodiments.

[0037] Terms indicating spatial relationships, such as “inside,” “outside,” “directly below,” “downward,” “below,” “above,” and “upwards,” are used herein to facilitate explanation when describing the relationship between one element or feature part and other elements or feature parts, as shown in the figures. Terms indicating spatial relationships may be intended to include cases where the device is oriented in different directions during use or operation, in addition to the orientation shown in the figures. For example, if the device in the figures is inverted, an element described as being “below” or “directly below” another element or feature part will be changed accordingly to being “above” that other element or feature part. Therefore, for example, the term “below” may include both upward and downward orientations. The device may be oriented in other directions (rotated 90 degrees or in other directions), and the descriptions of spatial relationships used herein shall be interpreted accordingly.

[0038] Various components are referred to herein as “operably connected.” As used herein, “operably connected” refers to components that are connected to one another in an operable manner, and includes embodiments in which components are directly connected, as well as embodiments in which other components are arranged between connected components. “Operatively connected” components can be “fluidically connected.” “Fluidally connected” refers to components that are connected together so that fluid can be transported between them. The term “fluidically connected” includes embodiments in which one component is placed between two fluidly connected components, and embodiments in which components are directly connected, etc. Fluidly connected components may include components that control the system by contacting other components but not by contacting the fluid (for example, a peristaltic pump that pumps fluid through a flexible tube by compressing the outside of the tube).

[0039] In this application, which includes the following definitions, the terms “module” or “controller” may be replaced with the term “circuit.” The term “module” may mean, or be part of, or include: application-specific integrated circuits (ASICs); digital, analog, or mixed analog / digital discrete circuits; digital, analog, or mixed analog / digital integrated circuits; combinational logic circuits; field-programmable gate arrays (FPGAs); processor circuits (shared, dedicated, or grouped) that execute code; memory circuits (shared, dedicated, or grouped) that store code executed by the processor circuits; other suitable hardware components that provide the described function; or any combination of some or all of the above, such as a system on a chip.

[0040] A module may include one or more interface circuits. In some exemplary embodiments, the interface circuits include wired or wireless interfaces connected to a local area network (LAN), the internet, a wide area network (WAN), or a combination thereof. The functionality of any given module in this disclosure may be distributed among multiple modules connected via interface circuits. For example, multiple modules enable load balancing. In another example, a server module (also known as a remote or cloud module) performs some functions on behalf of a client module.

[0041] The term "code" as used above may include software, firmware, and / or microcode, and may refer to programs, routines, functions, classes, data structures, and / or objects. The term "shared processor circuit" encompasses a single processor circuit that executes some or all of the code from multiple modules. The term "group processor circuit" encompasses a processor circuit that, in combination with additional processor circuits, executes some or all of the code from one or more modules. References to multiple processor circuits include multiple processor circuits on separate dies, multiple processor circuits on a single die, multiple cores in a single processor circuit, multiple threads in a single processor circuit, or a combination of the above. The term "shared memory circuit" encompasses a single memory circuit that stores some or all of the code from multiple modules. The term "group memory circuit" encompasses a memory circuit that, in combination with additional memory, stores some or all of the code from one or more modules.

[0042] The term "memory circuit" is included in what the term "computer-readable medium" refers to. As used herein, the term computer-readable medium does not include transient electrical or electromagnetic signals that propagate through a medium (like a carrier wave), and therefore the term computer-readable medium is considered tangible and non-transient. Non-limiting examples of non-transient tangible computer-readable medium include non-volatile memory circuits (such as flash memory circuits, erasable programmable read-only memory circuits, or mask read-only memory circuits), volatile memory circuits (such as static random-access memory circuits or dynamic random-access memory circuits), magnetic storage media (such as analog or digital magnetic tapes or hard disk drives), and optical storage media (such as CDs, DVDs, or Blu-ray discs).

[0043] The apparatus and methods described in this application may be partially or completely implemented by a dedicated computer 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 function as software specifications, which can be converted into a computer program by the routine work of a skilled technician or programmer.

[0044] A computer program includes processor-executable instructions stored in at least one non-transient, tangible, computer-readable medium. A computer program may also include, or depend on, stored data. A computer program may encompass a basic input / output system (BIOS) that interacts with the hardware of a dedicated computer, device drivers that interact with specific devices of the dedicated computer, one or more operating systems, user applications, background services, background applications, and the like.

[0045] A computer program includes (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 for execution by an interpreter; and (v) source code for compilation and execution by a runtime compiler. For example, source code is written using the syntax 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 5th revision), Ada, ASP (Active Server Pages), PHP (PHP: Hypertext Preprocessor), Scala, Eiffel, Smalltalk, Erlang, Ruby, Flash®, Visual Basic®, Lua, MATLAB, SIMULINK, and Python®.

[0046] Exemplary embodiments will be described in more detail with reference to the accompanying drawings.

[0047] This disclosure relates to means and methods 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 systems described in the following documents: U.S. Patent No. 10,585,085 (title: Collection of Fluid Components), issued on 10 March 2020, and / or U.S. Patent No. 9,758,764 (title: Separation of Compound Fluids), issued on 12 September 2017, and / or U.S. Patent No. 10,618,060 (title: Centrifugal Safety Mechanism), issued on 14 April 2020, and / or U.S. Patent No. 10,166,322 (title: In Separation Processes), issued on 1 January 2019. (Gains of the control loop), and / or U.S. Patent No. 9,440,011 (title: Hybrid blood component storage bag and method for manufacturing the same), issued on 13 September 2016, and / or U.S. Patent No. 8,523,750 (title: Method and apparatus for extracting platelets with low plasma carryover), issued on 3 September 2013, and / or U.S. Patent No. 8,123,713 (title: System and method for collecting plasma protein fractions from separated blood components), issued on 28 February 2012, and / or U.S. Patent No. 7,780,618 (title: Extracorporeal blood processing apparatus and method with pressure sensing), issued on 24 August 2010. The entire disclosure of the above applications is incorporated herein by reference. Methods using automated blood collection systems often generally include the steps of collecting whole blood from a donor, separating the whole blood into one or more selected components (e.g., platelets, red blood cells, plasma, etc.), and flushing the other unselected components (e.g., white blood cells, etc.) back to the donor.

[0048] Figure 1 illustrates an exemplary method 100 for monitoring the volume or amount of collected plasma and maintaining it within a pre-selected level (e.g., a circulating blood volume reduction limit) set by, for example, the regulations and guidelines of a government agency and / or blood center. The aforementioned pre-selected level is, for example, referred to as the “extraction level setting” when using an exemplary automated blood collection system. The extraction level setting is a donor-specific safe amount or safe volume of blood components selected for collection from the donor or subject. The extraction level setting may be determined using information entered or stored by the user / operator / donor (e.g., sex, height, weight, hematocrit value, and / or platelet count), as well as information measured during the collection in progress (e.g., inlet volume and / or amount of blood collected so far).

[0049] Method 100 includes the step of initiating a plasma collection process. This step includes performing one or more cycles, sequences, or stages (step 110) for separating, collecting, removing, or extracting one or more volumes of plasma from whole blood collected or received from a donor. The plasma is separated, collected, removed, or extracted from whole blood using one or more centrifugation systems of an automated blood collection system (step 110). During the separation, collecting, removing, or extraction of plasma, Method 100 performs step 120 of determining whether the expected cumulative volume loss or expected cumulative loss for the donor or subject is greater than a set removal level. In at least one exemplary embodiment, step 120 of determining may include monitoring both the volume pumped into a reservoir container and the volume pumped out of the reservoir container, and checking whether the difference between the two volumes is greater than a predetermined threshold or standard threshold (e.g., about 7 milliliters). If the above-mentioned difference is greater than a predetermined threshold or a standard threshold, a malfunction in the pump loading is possible, and in this case, method 100 proceeds to step 125. On the other hand, if the above-mentioned difference is less than a predetermined threshold or a standard threshold, a malfunction in the pump loading is not possible, and in this case, method 100 continues with the separation or collection or removal or extraction of plasma (i.e., step 110).

[0050] In at least one exemplary embodiment, the extraction level setpoint is multiplied by a volumetric accuracy offset value, and the multiplied extraction level setpoint is compared to the predicted cumulative volume loss. The product of the extraction level setpoint and the volumetric accuracy offset value is, in some examples, called the corrected extraction level setpoint and / or adjusted extraction level setpoint. The volumetric accuracy offset value helps to account for any deviation in volume. In at least one exemplary embodiment, the volumetric accuracy offset value is between about 1.02 and about 1.1. In certain embodiments, it is preferably 1.06. If the predicted cumulative volume loss is greater than or equal to the corrected extraction level setpoint, method 100 proceeds to step 125. If the predicted cumulative volume loss is less than the corrected extraction level setpoint, method 100 continues with the separation or collection or extraction or extraction of plasma (i.e., step 110).

[0051] Although not illustrated, it should be understood that in at least one exemplary embodiment, Method 100 may further include the step of determining the predicted cumulative volume loss, also called the volume / amount to be withdrawn. Calculating the predicted cumulative volume loss may be an iterative process that includes the step of taking real-time data. For example, in at least one exemplary embodiment, the predicted cumulative volume loss is equal to the sum of the volume obtained by subtracting the volume of the predicted anticoagulant (AC) in the platelets from the current predicted volume of platelets, the volume obtained by subtracting the volume of the predicted anticoagulant in the plasma from the current predicted volume of plasma, the volume obtained by subtracting the volume of the predicted anticoagulant in the red blood cells from the current predicted volume of red blood cells, and the volume accumulated in the reservoir container shutdown monitor. Simply put, the predicted cumulative volume loss = (current predicted volume of platelets - predicted volume of anticoagulant in platelets) + (current predicted volume of plasma - predicted volume of anticoagulant in plasma) + (current predicted volume of red blood cells - predicted volume of anticoagulant in red blood cells) + volume accumulated in the reservoir container shutdown monitor.

[0052] It should be understood that, although not illustrated, in at least one exemplary embodiment, Method 100 may also include at least one of the following steps: determining the current predicted volume of platelets; determining the predicted volume of anticoagulant in platelets; determining the current predicted volume of plasma; determining the predicted volume of anticoagulant in plasma; determining the current predicted volume of red blood cells; determining the predicted volume of anticoagulant in red blood cells; and determining the volume accumulated in the reservoir container shutdown monitor. In at least one exemplary embodiment, the volume accumulated in the reservoir container shutdown monitor is, as described above, the difference between the amount / volume pumped into the reservoir container and the amount / volume pumped out of the reservoir container.

[0053] Referring again to Figure 1, if the predicted cumulative volume loss is greater than or equal to the (corrected) extraction level setpoint, method 100 may perform the steps of generating, sending, or initiating an alarm or alert (as shown in Figure 2) to the user or graphical interface or screen of the automated blood collection system, and / or stopping one or more pumps of the automated blood collection system to abort plasma collection. The user interface may also include a flag indicating that the collected plasma may be contaminated, for example, with leukocytes. As shown in Figure 2, the alarm pushed to the user interface may include one or more prompts. For example, using the user interface, the user or operator of the blood collection system may choose to terminate or continue collection after investigation, or choose to enter a new process. For example, as shown in Figure 1, if the user or operator chooses to continue collection, method 100 proceeds to step 130. If the user or operator enters a new process, method 100 proceeds to step 150. If the user or operator chooses to terminate the execution, method 100 proceeds to step 160.

[0054] Depending on the user or operator's choice, method 100 continues the separation or collection or removal or extraction of plasma in step 130. During the ongoing or continued separation or collection or removal or extraction of plasma, method 100 may perform step 140 to determine whether the sum of the volume of plasma actually collected, the currently predicted volume of platelets, and the currently predicted volume of red blood cells is greater than or equal to the total blood volume limit, or in some cases near the 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 each individual donor.

[0055] In at least one exemplary embodiment, the total blood volume limit is multiplied by a volumetric precision offset value to account for volume deviations before comparing the total blood volume limit with the sum of the actually collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume. The multiplied total blood volume limit is then compared with the sum of the actually collected plasma volume, the currently predicted platelet volume, and the currently predicted red blood cell volume. The volumetric precision offset value used to adjust the total blood volume limit may be the same as or different from the volumetric precision offset value used to adjust the extraction level setpoint. For example, in at least one exemplary embodiment, the volumetric precision offset value for adjusting the total blood volume limit is between approximately 1.02 and approximately 1.1. In certain embodiments, this value is 1.06. The product of the total blood volume limit and the volumetric precision offset value is, in certain examples, referred to as the corrected or adjusted total blood volume limit.

[0056] If the sum of the volume of plasma actually collected, the currently predicted volume of platelets, and the currently predicted volume of red blood cells is less than the (corrected) total blood volume limit, method 100 continues with the separation or collection or removal or extraction of plasma (i.e., step 130). If the sum of the volume of plasma actually collected, the currently predicted volume of platelets, and the currently predicted volume of red blood cells is greater than or equal to the (corrected) total blood volume limit, method 100 proceeds to step 145. Here, method 100 terminates plasma collection and displays other or second alarms (e.g., as shown in Figure 3) regarding the separation or collection or removal or extraction of plasma on the user interface of the automated blood collection system. As shown in Figure 3, the other alarms described above may include messages indicating that the system continues to detect that there may be too much plasma and that plasma collection has been terminated. The other alarms described above may include prompts instructing the user or operator to select a prompt to start or continue collecting other blood products, such as platelets and red blood cells. The user interface may also include flags to indicate other warnings, such as when the collected plasma may be contaminated with white blood cells.

[0057] Referring again to Figure 1, Method 100 performs one or more cycles, sequences, or stages to separate, collect, remove, or extract one or more volumes of platelets and / or one or more volumes of red blood cells from whole blood collected or received from a donor, depending on whether the sum of the volume of plasma actually collected, the currently predicted volume of platelets, and the currently predicted volume of red blood cells is greater than or equal to the (corrected) total blood volume limit, or depending on the actions of the user or operator in steps 120 to 145 (step 150). The volume of platelets and / or the volume of red blood cells are separated, collected, removed, or extracted from whole blood after the removal of one or more volumes of plasma using one or more centrifugation systems of the automated blood collection system (step 150). After the platelets and / or red blood cells have been collected, Method 100 displays a collection completion screen on the user interface (step 170), and then initiates rinse-back (step 180), during which any uncollected blood components and / or excess material are returned to or pushed back to the donor. Once rinseback is performed, method 100 displays an execution completion notification on the user interface (step 190) and terminates the collection.

[0058] If the user or operator chooses to terminate the execution when the first alarm is displayed, method 100 proceeds to decision point 160, where the user or operator decides whether to initiate rinseback or not. If the user or operator decides to initiate rinseback, method 100 proceeds to step 180. On the other hand, if the user or operator decides not to perform rinseback, method 100 displays an execution termination notification on the user interface (step 190) and terminates the sampling.

[0059] This configuration allows collection to continue beyond the plasma alarm, up to a pre-selected upper limit level (e.g., circulating blood volume reduction limit) set by government agency and / or blood center regulations and guidelines. Furthermore, because the prediction is used for the plasma method, this configuration allows platelet and red blood cell collection to be completed. It can also provide the user or operator with the option to select a lower volume process if necessary. Moreover, this configuration utilizes the actual volume collected in the plasma collection bag of the automated blood collection system, rather than the predicted volume at the end of the process, allowing the user or operator to collect the available volume in many cases.

[0060] The above description of embodiments is provided for illustrative and explanatory purposes only. It is not intended to be exhaustive or to limit the disclosure. Individual elements or features of a particular embodiment are generally interchangeable and may be used in selected embodiments, even if not specifically illustrated or described, as applicable, and are not limited to that particular embodiment. They may also be modified in many ways. Such modifications should not be considered deviations from the disclosure, and all such variations are intended to be within the scope of the disclosure.

Claims

1. A method for collecting blood components from a subject using an automated blood collection system, wherein the method is The steps include separating plasma from whole blood received from the subject, Steps include: initiating an alarm when the predicted cumulative volume loss is greater than a set extraction level, wherein the predicted cumulative volume loss is determined by the cumulative volume including the volume of the separated plasma, and the set extraction level is defined by the level of circulating blood volume reduction for the subject or a pre-selected maximum value; The steps include: terminating the blood component collection process, continuing the collection process, or initiating the separation of platelets and red blood cells in response to the alarm and feedback from the operator of the automated blood collection system; Having, method.

2. The method according to claim 1, further, The method includes the step of determining the predicted cumulative volume loss by summing the volume obtained by subtracting the volume of anticoagulant predicted in the platelets from the currently predicted volume of platelets, the volume obtained by subtracting the volume of anticoagulant predicted in the plasma from the currently predicted volume of plasma, the volume obtained by subtracting the volume of anticoagulant predicted in the red blood cells from the currently predicted volume of red blood cells, and the cumulative volume detected by the reservoir container monitor. method.

3. The method according to claim 1, further, The process includes a step of determining the extraction level setting value by multiplying the circulating blood volume reduction level or the pre-selected maximum value for the subject by a volumetric accuracy offset value. method.

4. In the method described in claim 3, The aforementioned volumetric accuracy offset value is approximately 1.02 or more and approximately 1.1 or less. method.

5. In the method described in claim 4, The volumetric accuracy offset value is 1.

06. method.

6. In the method described in claim 1, Terminating the aforementioned sampling process includes initiating rinseback. method.

7. In the method described in claim 1, Continuing the collection process includes continuing to separate plasma from the whole blood received from the subject, method.

8. In the method described in claim 7, the method further includes: During the separation of the plasma, the process includes comparing the sum of the actual volume of plasma collected, the currently predicted volume of platelets, and the currently predicted volume of red blood cells with the total blood volume limit. method.

9. In the method according to claim 8, the method further, The method includes the step of initiating the separation of platelets and red blood cells if the sum of the volume of actual plasma collected, the currently predicted volume of platelets, and the currently predicted volume of red blood cells is greater than the total blood volume limit. method.

10. In the method according to claim 8, the method further, If the sum of the actual volume of plasma collected, the currently predicted volume of platelets, and the currently predicted volume of red blood cells is less than the total blood volume limit, the process includes the step of continuing to separate the plasma from the whole blood received from the subject. method.

11. In the method described in claim 8, The aforementioned total blood volume limit is 15% of the total blood volume calculated for the subject. method.

12. In the method described in claim 8, The total blood volume limit is multiplied by a volume accuracy offset value, and the multiplied total blood volume limit is compared with the sum of the volume of the actual plasma collected, the currently predicted volume of platelets, and the currently predicted volume of red blood cells. method.

13. In the method according to claim 12, The aforementioned volumetric accuracy offset value is approximately 1.02 or more and approximately 1.1 or less. method.

14. In the method described in claim 1, the method further includes: The process includes a step of initiating a rinse-back after the collection of platelets and red blood cells has begun. method.

15. A method for collecting blood components from a subject using an automated blood collection system, wherein the method is The steps include separating plasma from whole blood received from the subject, A step of comparing the predicted cumulative volume loss with a set withdrawal level, wherein the predicted cumulative volume loss is determined by the cumulative volume including the volume of the separated plasma, and the set withdrawal level is defined by the level of circulating blood volume reduction for the subject or a pre-selected maximum value. If the predicted cumulative volume loss is greater than the set extraction level, the step of generating an alarm for the user of the automated blood collection system, comprising: a first of the at least three prompts comprising terminating the collection process in response to the alarm; a second of the at least three prompts comprising continuing the separation of the plasma from the whole blood, ignoring the alarm; and a third of the at least three prompts comprising terminating the plasma collection stage and initiating a platelet collection stage, or an erythrocyte collection stage, or a combination of the platelet collection stage and the erythrocyte collection stage. Having, method.

16. The method according to claim 15, further, The step of determining the predicted cumulative volume loss by summing the volume obtained by subtracting the volume of anticoagulant predicted in the platelets from the currently predicted volume of platelets, the volume obtained by subtracting the volume of anticoagulant predicted in the plasma from the currently predicted volume of plasma, the volume obtained by subtracting the volume of anticoagulant predicted in the red blood cells from the currently predicted volume of red blood cells, and the cumulative volume detected by the reservoir container monitor. The steps include determining the extraction level setting value by multiplying the circulating blood volume reduction level or the pre-selected maximum value for the subject by a volumetric accuracy offset value, Having, method.

17. In the method according to claim 15, the method further, If the aforementioned alarm is ignored, the process includes comparing the sum of the actual volume of plasma collected, the currently predicted volume of platelets, and the currently predicted volume of red blood cells with the total blood volume limit. method.

18. In the method described in claim 17, If the sum of the actual volume of plasma collected, the currently predicted volume of platelets, and the currently predicted volume of red blood cells is greater than the total blood volume limit, the collection of platelets and red blood cells will be initiated. If the sum of the actual volume of plasma collected, the currently predicted volume of platelets, and the currently predicted volume of red blood cells is less than the limit of total blood volume, the separation of the plasma from the whole blood is continued. method.

19. In the method described in claim 17, The aforementioned total blood volume limit is 15% of the total blood volume calculated for the subject. method.

20. In the method described in claim 17, The total blood volume limit is multiplied by a volume accuracy offset value, and the multiplied total blood volume limit is compared with the sum of the volume of the actual plasma collected, the currently predicted volume of platelets, and the currently predicted volume of red blood cells. method.

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