Method and system for determining the individual-specific amount of data to be collected.

Abstract

A method for collecting blood components using a medical system, the method comprising: receiving data associated with a subject by the medical system, the data associated with the subject including the subject's initial hematocrit value; determining the amount of subject-specific pure component to be collected by the medical system, the amount of subject-specific pure component to be collected by the medical system being determined using the subject's hematocrit value, the subject's total blood volume, and a target change in the hematocrit value; and performing a component collection process using the medical system to collect the determined amount of subject-specific pure component.

Description

[Technical Field]

[0001] (Cross-reference of related applications) This application claims priority to U.S. Patent Application No. 18 / 644,259, filed on April 24, 2024, and also claims the benefit of U.S. Provisional Patent Application No. 63 / 462,636, filed on April 28, 2023. The entire disclosure of the above application is incorporated herein by reference.

[0002] This disclosure relates in general to the separation of components from multi-component fluids, and more particularly to apheresis methods and systems. [Background technology]

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

[0004] There are two common methods for blood collection. The first common method is to receive whole blood from a donor. Once whole blood is obtained, a centrifugation process can be used to separate blood components from the whole blood, for example, based on the density of different blood components. The desired components can be transferred to collection containers manually, semi-automatically, or automatically during and / or after the application of centrifugal force. The second common method is called apheresis collection, which requires specialized equipment. For example, in the apheresis method, whole blood is extracted from the donor while the donor is connected to an apheresis device, which is a specialized device. The whole blood is then centrifuged to collect only the desired blood components (e.g., plasma, platelets), and all other blood components are returned to the donor while they are still connected for collection or during the same cycle. The donor remains connected to the apheresis device during the separation and collection of blood components. A safe and acceptable collection volume for separation and collection can be determined according to specific characteristics unique to the donor, such as height, weight, hematocrit value, and / or hemoglobin. [Overview of the project] [Problems that the invention aims to solve]

[0005] This section provides a general overview of the disclosure and does not constitute a comprehensive disclosure of its entire scope or all features.

[0006] This disclosure aims to provide a method for collecting blood components using a medical system. [Means for solving the problem]

[0007] This disclosure provides a method for collecting blood components using a medical system. In at least one exemplary embodiment, the method includes: receiving data associated with a subject by the medical system, the data associated with the subject including the subject's initial hematocrit value; determining an amount of subject-specific pure component to be collected by the medical system, the amount of subject-specific pure component to be collected by the medical system being determined using the subject's initial hematocrit value, the subject's initial total blood volume, and a target change in hematocrit value; and performing a component collection process using the medical system to collect the determined amount of subject-specific pure component.

[0008] In at least one exemplary embodiment, the step of receiving the data associated with the subject may include the step of scanning an image using a scanner.

[0009] In at least one exemplary embodiment, the scanner may be located within the medical system.

[0010] In at least one exemplary embodiment, the image may include a one-dimensional barcode, a two-dimensional barcode, or a combination of a one-dimensional barcode and a two-dimensional barcode.

[0011] In at least one exemplary embodiment, the method may further include the steps of: determining the identification of a subject using the data associated with the subject received by the medical system; and adjusting one or more parameters of the component collection process by the medical system.

[0012] In at least one exemplary embodiment, the method may further include the steps of: receiving data associated with a blood component collection set by the medical system; and adjusting one or more parameters of the component collection process by the medical system.

[0013] In at least one exemplary embodiment, the method may further include the steps of: receiving data associated with an ingredient collection bottle by the medical system; and adjusting one or more parameters of the ingredient collection process by the medical system.

[0014] In at least one exemplary embodiment, the data associated with the subject may further include the total blood volume.

[0015] In at least one exemplary embodiment, the method may further include the step of determining the total blood volume of the subject using the data associated with the subject received by the medical system.

[0016] In at least one exemplary embodiment, the method may further include the step of determining the body mass index of the subject using the data associated with the subject received by the medical system.

[0017] In at least one exemplary embodiment, the target change in the hematocrit value may be a constant pre-selected from a range of about 1% to about 15%.

[0018] In at least one exemplary embodiment, the target change amount of the hematocrit value may be selected based on the starting hematocrit value of the subject and the acceptable hematocrit value after component collection.

[0019] In at least one exemplary embodiment, the difference between the starting hematocrit value of the subject and the acceptable hematocrit value after component collection may be in the range of about 1% to about 15%.

[0020] In at least one exemplary embodiment, the target change amount of the hematocrit value may be about 8%.

[0021] In at least one exemplary embodiment, the amount of the subject-specific pure component contains only plasma, and the amount of the subject-specific pure component to be collected by the medical system may be determined by the medical system according to the following relationship:

Number

[0022] In at least one exemplary embodiment, the method may further include, after receiving the data associated with the subject, using a feedback system to confirm the receipt of the data.

[0023] In at least one exemplary embodiment, the feedback system may include a speaker, a graphical user interface, or a speaker combined with a graphical user interface.

[0024] Further scope will become apparent from the descriptions provided herein. The descriptions and specific examples in this summary are for illustrative purposes only and are not intended to limit the scope of this disclosure.

[0025] The drawings herein are for illustrative purposes only of selected embodiments and are not intended to limit the scope of this disclosure to all possible embodiments. [Brief explanation of the drawing]

[0026] [Figure 1] Figure 1 is a perspective view of the operating environment of an apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 2] Figure 2 is a perspective view of the apheresis system shown in Figure 1, with the access door in the closed position, according to at least one exemplary embodiment of the present disclosure. [Figure 3] Figure 3 is a perspective view of the apheresis system shown in Figures 1 and 2, with the access door in the open position and the centrifuge assembly exposed, according to at least one exemplary embodiment of the present disclosure. [Figure 4] Figure 4 is a functional diagram of one embodiment of the apheresis system shown in Figures 1 to 3, according to at least one exemplary embodiment of the present disclosure. [Figure 5] Figure 5 is a block diagram of the electrical system of the apheresis system shown in Figures 1 to 4, according to at least one exemplary embodiment of the present disclosure. [Figure 6] Figure 6 is another block diagram of the electrical system of the apheresis system shown in Figures 1 to 5, according to at least one exemplary embodiment of the present disclosure. [Figure 7] Figure 7 is another block diagram of the electrical system of the apheresis system shown in Figures 1 to 5, according to at least one exemplary embodiment of the present disclosure. [Figure 8]Figure 8 is a flowchart illustrating a method of using the apheresis system shown in Figures 1 to 7, according to at least one exemplary embodiment of the present disclosure. [Figure 9] Figure 9 is a perspective view of the apheresis system shown in Figures 1 to 8, according to at least one exemplary embodiment of the present disclosure. [Figure 10] Figure 10 is a block diagram of a computing system of the apheresis system shown in Figures 1 to 9, according to at least one exemplary embodiment of the present disclosure. [Figure 11] Figure 11 shows a network-connected apheresis system as shown in Figures 1 to 10, according to at least one exemplary embodiment of the present disclosure. [Figure 12] Figure 12 shows an exemplary graphical user interface of the apheresis system shown in Figures 1 to 10, according to at least one exemplary embodiment of the present disclosure. [Figure 13] Figure 13 is a flowchart illustrating an exemplary method for determining the amount or volume of donor-specific pure plasma to be collected (referred to as “donated plasma”), according to at least one exemplary embodiment of the present disclosure. [Modes for carrying out the invention]

[0027] The corresponding reference numerals indicate the corresponding parts in the above diagram.

[0028] Exemplary embodiments will be described in more detail with reference to the accompanying drawings.

[0029] Exemplary embodiments are provided to those skilled in the art so that the disclosure may be complete and its scope fully conveyed. Numerous specific details, such as examples of specific components, apparatus, and methods, are described in order to provide a complete understanding of the embodiments of the 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 the disclosure. In some exemplary embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.

[0030] The terms used herein are for illustrative purposes only and are not intended to limit the use of any particular exemplary embodiment. 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 existence of the described features, entities, steps, actions, elements, and / or components, but do not exclude the existence or addition of one or more other features, integers, 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.

[0031] When an element or layer is referred to as "on top of," "engaged to," "connected to," or "joined to" another element or layer, it may be directly on, directly engaged to, directly connected to, or directly joined 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 "joined to" another element or layer, no intervening element or layer exists. 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.

[0032] The terms "first," "second," "third," etc., may be used herein to describe various elements, components, regions, layers, and / or parts, but these elements, components, regions, layers, and / or parts 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 part described below may also be called the second element, second component, second region, second layer, or second part, without departing from the teaching of the exemplary embodiments.

[0033] Terms indicating spatial relationships, such as “inside,” “outside,” “directly below,” “downward,” “below,” “above,” and “up,” 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. These 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 (by being rotated 90 degrees or in other directions), and the descriptions of spatial relationships used herein shall be interpreted accordingly.

[0034] 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 a fluid can be transported between them. The term “fluidically connected” includes embodiments in which other components are arranged 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).

[0035] 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.

[0036] A module may include one or more interface circuits. In some examples, 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 other examples, a server module (also known as a remote or cloud module) performs some functions on behalf of a client module.

[0037] 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.

[0038] 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).

[0039] 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.

[0040] 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.

[0041] 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®.

[0042] Exemplary embodiments will be described in more detail with reference to the accompanying drawings.

[0043] This disclosure relates to a method and means for collecting one or more blood components, such as plasma, using a medical system. In at least one exemplary embodiment, the medical system may include an apheresis system such as the apheresis system described in the following documents: U.S. Patent No. 11,090,425, issued August 17, 2021 (title: Method and System for High-Throughput Blood Component Collection); U.S. Patent Application No. 18 / 117,035, filed March 3, 2023 (title: Soft Cassette with Integrated Functional Parts); U.S. Patent Application No. 18 / 117,035, filed March 3, 2023 U.S. Patent Application No. 6,919 (Title: Blood Component Collection Bladder); U.S. Patent Application No. 18 / 117,077 (Title: Integrated Code Scanning System and Apheresis Data Control Method) filed March 3, 2023; U.S. Patent Application No. 18 / 117,044 (Title: Method and System for Calibration, Maintenance and Inspection of Apheresis Systems) filed March 3, 2023; U.S. Patent Application No. 18 / 116,902 (Title: Mobile Blood Component Collection Loop Holder) filed March 3, 2023; 20 U.S. Patent Application No. 18 / 116,958 (Title: Bottle Tray with Magnetic Coupling and Load Cell Overload Protection), filed on March 3, 2023; U.S. Patent Application No. 18 / 116,988 (Title: Communication Control and Operation Control of Apheresis Systems), filed on March 3, 2023; U.S. Patent Application No. 18 / 117,006 (Title: Method and Interface for Providing Feedback in a Blood Collection Process), filed on March 3, 2023; U.S. Patent Application No. U.S. Patent Application No. 18 / 117,007 (Title: Modular Maintenance Thread and Interconnection); U.S. Patent Application No. 18 / 116,908 (Title: Collection Bottle with Integrated Lid, Handle and Shielding Function) filed March 3, 2023; U.S. Patent Application No. 18 / 116,992 (Title: Method for Automatically Adjusting Fluid Flow) filed March 3, 2023; U.S. Patent Application No. 18 / 116,999 (Title: Safety Function Part of Apheresis System) filed March 3, 2023;U.S. Patent Application No. 18 / 117,029 (title: Automatic Operation Control Based on Detected Environmental Conditions), filed March 3, 2023; U.S. Patent Application No. 18 / 116,954 (title: Tube Condition Sensor Based on Flexibility), filed March 3, 2023; U.S. Patent Application No. 18 / 117,035 (title: Soft Cassette with Integrated Functional Parts), filed March 3, 2023; and U.S. Patent Application No. 18 / 117,073 (title: Blood Component Collection Set with Integrated Safety Functional Parts), filed March 3, 2023. The entire disclosures of the above applications are incorporated herein by reference.

[0044] An apheresis system generally includes one or more connections configured to move whole blood and / or blood components to and from a blood component separator housed within the apheresis system, the blood component separator being a centrifuge. For example, Figure 1 shows a perspective view of an operating environment 100 of an apheresis system 200 according to at least one exemplary embodiment of the present disclosure. The operating environment 100 includes the apheresis system 200, a subject or donor or source 102, and one or more connections (e.g., a donor supply tube 104, a cassette inlet tube 108A, an anticoagulant (AC) tube 110, etc.) extending from the donor 102 to the apheresis system 200 and / or vice versa. The donor supply tube 104 may be fluidly connected to at least one blood vessel of the donor 102, e.g., a vein, via venipuncture. For example, a cannula connected to the end of the donor supply tube 104 is inserted into the skin of the donor 102 and into the target site, i.e., a vein. This connection provides a venous pathway for blood to flow from the donor 102 to the apheresis system 200 and / or for blood components to flow back to the original donor 102. Whole blood supplied from the donor 102 flows along the donor supply tube 104 through the tube connector 106 and into the soft cassette assembly 300 along the cassette inlet tube 108A. The soft cassette assembly 300 may include one or more fluid control pathways and valves for selectively controlling the flow of blood to and from the donor 102. The apheresis system 200 can supply an anticoagulant contained in an anticoagulant bag 114. The anticoagulant is pumped through at least the anticoagulant tube 110 and the tube connector 106 to prevent blood clotting in the apheresis system 200.

[0045] Figure 2 shows a perspective view of the apheresis system 200 described in Figure 1. The apheresis system 200 enables a continuous whole blood separation process. In at least one exemplary embodiment, whole blood is collected from donor 102 and supplied substantially continuously to the blood component separator of the apheresis system 200. In the blood component separator, the blood is separated into various components, and at least one of these blood components is collected from the apheresis system 200. In at least one exemplary embodiment, one or more of the separated blood components may be collected for subsequent use or returned to donor 102. Blood is collected from donor 102 and guided to the centrifuge of the apheresis system 200 through the opening 220 of the access panel 224 of the apheresis system 200. In at least one exemplary embodiment, the tubes used in the extracorporeal tubing circuit—a donor supply tube 104, a cassette inlet tube 108A, an inlet tube 108B (also known as the loop inlet tube 108B), an outlet tube 112 (also known as the loop outlet tube 112), a saline tube 116, and a plasma tube 120—together constitute a closed-system sterile disposable system or blood component collection set, as further described below.

[0046] The operation of various pumps, valves, and blood component separators (e.g., centrifuges) may be controlled by one or more processors included in the apheresis system 200, and preferably by multiple embedded computer processors that are part of a computer system. The computer system may include components that allow a user to interface with the computer system, including, for example, memory and storage devices (RAM, ROM (e.g., CD-ROM, DVD), magnetic drives, optical drives, flash memory, etc.), communication / network devices (e.g., wired such as modems / network cards, or wireless such as WiFi), input devices such as keyboards, touchscreens, cameras, and / or microphones, and output devices such as displays and audio systems. It should be understood that, although not shown, in at least one exemplary embodiment, the blood component separator (e.g., centrifuge) may include a graphical user interface having a display including an interactive touchscreen to assist the operator of the apheresis system 200 in various modes of operation of the apheresis system 200.

[0047] The apheresis system 200 may include a housing 204 and / or a structural frame, a cover 210, access panels 224 positioned on the front portion 202 and / or rear portion 206 of the apheresis system 200, and one or more supports 232A-232C. The supports include hooks, rests, cradles, arms, protrusions, plates, and / or other support functional parts for holding, placing, and / or supporting containers or anticoagulant bags 114, saline bags 118, plasma collection bottles 122. The housing 204 may include an apparatus frame (e.g., formed from welded, bolted, and / or connected structural elements, extruded material, beams, etc.) to which one or more panels, such as the cover 210, doors, subassemblies, and / or components, are attached. In at least one exemplary embodiment, at least one panel of the apheresis system 200 may include a mounting surface for a soft cassette assembly 300, one or more pumps such as a draw pump 208, a return pump 212, an anticoagulant pump 216, and / or a fluid valve control system 228 (e.g., plasma-saline valve control).

[0048] The access panel 224 may include one or more handles, locks, and pivot or hinge axes (e.g., door hinges, piano hinges, continuous hinges, cleanroom hinges, etc.). The access panel 224 is selectively opened to allow access to the interior of the apheresis system 200, more specifically, to the blood separation assembly (e.g., the centrifuge assembly). For example, the device can be accessed through the access panel 224 to attach and / or detach one or more components in a blood component collection set to the centrifuge. In at least one exemplary embodiment, the interior of the apheresis system 200 may be separated into at least a centrifuge section and a control section. For example, the centrifuge section includes a cavity configured to receive a centrifuge, a rotary motor, and associated hardware. This area may be physically separated from the control section by one or more walls of the cavity. In at least one exemplary embodiment, access to the control unit (for example, configured to house or include a motor controller, CPU or processor, electronic equipment, and / or wiring) may be provided by a panel separate from the rigidly fastened panel of the housing 204 and / or the access panel 224.

[0049] In at least one exemplary embodiment, the apheresis system 200 includes a plurality of pumps, such as an intake pump 208, a return pump 212, or an anticoagulant pump 216, configured to control the flow of fluid (e.g., blood and / or blood components, anticoagulants and / or saline solution, etc.) through the apheresis system 200. As shown in Figure 2, in at least one exemplary embodiment, the intake pump 208, the return pump 212, and / or the AC pump 216 may be at least partially located on top of the cover 210 of the apheresis system 200. In at least one exemplary embodiment, the intake pump 208 can control the blood flow to and / or from the donor 102 to the centrifuge of the apheresis system 200. For example, the intake pump 208 may engage with the portion of the inlet tube 108B that is located between the soft cassette assembly 300 and the centrifuge of the apheresis system 200. In at least one exemplary embodiment, the return pump 212 is configured to control the flow of separated blood components (e.g., plasma) from the centrifuge to the plasma collection bottle 122 and / or the reverse flow. In addition to or instead of this, the return pump 212 may control the flow of saline (e.g., supplied from the saline bag 118) throughout the blood component collection set and / or the apheresis system 200. In at least one exemplary embodiment, the anticoagulant pump 216 may engage with a portion of the anticoagulant tube 110 to selectively control the flow of anticoagulant throughout the blood component collection set of the apheresis system 200.

[0050] Figure 3 shows an exemplary centrifuge assembly 400 for use in an apheresis system 200 according to at least one exemplary embodiment of the present disclosure. For example, the centrifuge assembly 400 may be located in the internal space of the apheresis system 200. The internal space may be at least partially enclosed by one or more elements of the housing 204 and / or the centrifuge chamber. Access to the internal space and the centrifuge assembly 400 may be provided by an access panel 224 located in the front portion 202 of the apheresis system 200. For example, in Figure 3, the access panel 224 is shown in an open position, open along a hinge axis 226. The hinge axis 226 may correspond to a door hinge, a continuous hinge, a cleanroom hinge, and / or other panel hinges.

[0051] The centrifuge assembly 400 is operably mounted inside the apheresis system 200 so that the centrifuge assembly 400 can rotate relative to the housing 204 and / or other elements of the apheresis system 200. One or more parts of the blood component collection set are loaded into the centrifuge assembly 400 by routing tubes (e.g., inlet tube 108B and outlet tube 112, etc.) into the internal space of the apheresis system 200 (e.g., through the opening 220 shown in Figure 2), connecting a portion of the blood component collection loop 520 to the fixed loop connector 402, and inserting the blood component collection bladder into the filler 460. The fixed loop connector 402 maintains the inlet tube 108B and outlet tube 112 in a fixed position and prevents the tubes 108B and 112 from twisting outside the apheresis system 200. In at least one exemplary embodiment, the blood component collection loop may be interconnected with the fixed loop connector 402 via one or more key function parts or positive location features.

[0052] Figure 4 shows a functional diagram of the apheresis system 200 shown in Figures 1 to 3. Figure 4 shows the components introduced earlier in a functional diagram to illustrate the operation of the system 200 for extracting plasma or other blood components from the whole blood of a donor 102 during an apheresis procedure or process. For example, as shown in Figure 4, the anticoagulant pump 216 is configured to pump fluid from the anticoagulant bag 114 into the anticoagulant tube 110. In at least one exemplary embodiment, the anticoagulant tube 110 also includes an anticoagulant air detection sensor (ADS) 804 configured to detect air or fluid in the anticoagulant tube 110. The anticoagulant tube 110 is fluidically associated with the donor supply tube 104 and the cassette inlet tube 108A by intersecting them at a tube connector 106. The tube connector 106 may be any type of connector configured to connect different tubes 110, 104 and / or tube 108A.

[0053] The donor supply tube 104 extends from the donor 102, in which case the donor 102 may be punctured with a lumen needle or other device, thereby allowing whole blood to flow from the donor 102 into the apheresis system 200 and blood components to flow back into the donor 102. Tube 108A extends to the soft cassette 340. In at least one exemplary embodiment, a donor air detection sensor (ADS) 312 may be located on or inside tube 108A. The donor air detection sensor may be configured to detect the presence of fluid and / or air in tube 108A.

[0054] The soft cassette 340 may include a first cassette port 360A through which tube 108A is divided into first and second tube sections. For example, the first cassette port 360A functions as and / or includes and / or substantially adjacent to a "Y" connector or "Y" section that separates tube 108A into a first bypass branch 358A and a first tube section 368A. The two tube sections are reconnected at a second cassette port, similar to the first cassette port 360A. This second cassette port also functions as and / or includes and / or adjacent to a "Y" connector or "Y" section. In at least one exemplary embodiment, one tube is bifurcated by a fluid sensor 316 to form a first bypass branch 358A and a second bypass branch 358B. In at least one exemplary embodiment, the first bypass branch 358A may include a first fluid control valve 320C. In at least one exemplary embodiment, the other tube is bifurcated by a drip chamber 354 to form a first tube section 368A and a second tube section 368B. The drip chamber 354 is configured to collect a predetermined amount of whole blood and / or high hematocrit blood (blood with a high percentage of red blood cells) in response to the operation of the system 200. In at least one exemplary embodiment, the first tube section 368A includes a second fluid control valve 320A, while the second tube section 368B includes a third fluid control valve 320B. The fluid control valves 320A, 320B, and 320C may be configured to isolate the tube sections 358A, 368A, 358B, and 368B.

[0055] The inlet tube 108B can be connected to the second cassette port 360B and can also connect the soft cassette 340 to the flexible loop 524. In at least one exemplary embodiment, the inlet tube 108B may include a sensor 808 located on or inside the tube 108B upstream of the system fixed loop connector 528 of the flexible loop 524. In at least one exemplary embodiment, the inlet tube 108B includes a pressure sensor (CPS) 808 located between the second cassette port 360B and the system fixed loop connector 528. In each example, the intake pump 208 is configured to deliver fluid through the tube 108B either away from or towards the soft cassette 340.

[0056] Two or more different tubes can be connected to the flexible loop 524 via the system fixed loop connector 528, and two or more different tubes can supply fluid to or receive fluid from the blood component collection bladder 536. In at least one exemplary embodiment, the outlet tube 112 is connected to the flexible loop 524 via the system fixed loop connector 528. In at least one exemplary embodiment, the outlet tube 112 has another line sensor 812 located on or within it. This line sensor is configured to detect fluid, air, cell concentration, color, and / or color changes in the fluid moving out of the flexible loop 524. In at least one exemplary embodiment, a second pressure sensor or fluid sensor 816 is also located in or on the line 112. The sensor 816 is configured to detect one or more of the presence or absence of fluid in the outlet tube 112, the pressure in the outlet tube 112, and / or other characteristics of the fluid in the outlet tube 112. In each example, the outlet tube 112 flows into the plasma air detection sensor 284 before the saline / plasma tube y-connector 280 separates the outlet tube 112 into the saline tube 116 and the plasma tube 120. In at least one exemplary embodiment, the return pump 212 engages with the outlet tube 112 to allow fluid or air to flow through the outlet tube 112 from the flexible loop 524, or from the saline bag 118 and / or the plasma collection bottle 122.

[0057] Figure 5 shows an exemplary electrical and control system 900 that controls the functions of the apheresis system 200 shown in Figures 1 to 4. Generally, the control system 900 may include one or more nodes. The nodes may include various hardware, firmware, and / or software configured to control and / or communicate with the mechanical, electromechanical, and electrical components of the apheresis system 200. Each node may be configured to control a different part of the apheresis system 200. For example, the control system 900 has a cassette node 904 and a centrifuge node 908. The cassette node 904 is a soft cassette assembly system and is configured to control and / or communicate with the components of a blood component collection set (and / or associated hardware or mechanical components that interface with the blood component collection set or its components). The centrifuge node 908 is a centrifuge system and is configured to control and / or communicate with a centrifuge assembly 400 (and / or associated hardware or mechanical components associated with the centrifuge assembly 400 or its components). In at least one exemplary embodiment, the cassette node 904 and the centrifuge node 908 may communicate with each other wirelessly or via some other electrical or data connection. In at least one exemplary embodiment, the cassette node 904 and the centrifuge node 908 may be separate parts of a single node or a single system 902. In at least one exemplary embodiment, the cassette node 904 and the centrifuge node 908 may have identical or different physical hardware used to operate and / or control different functions.

[0058] Each of the cassette node 904 and the centrifuge node 908 may communicate with one or more sensors 916, 920 and / or sensor 924. There may be more or fewer sensors than those shown in Figure 9, as indicated by the abbreviation 928. Each of the cassette node 904 and / or the centrifuge node 908 may communicate directly with each of the sensors 916-924, or, in other embodiments, may communicate with the sensors 916-924 via bus 912. Bus 912 may communicate by any type of communication protocol, such as Universal Serial Bus (USB), Universal Asynchronous Transceiver (UART), or other types of bus systems or parallel communication connections. Sensors 916-924 may be any type of sensor capable of communicating information, for example, about light, fluid, presence of air, color, and / or pressure. Some examples of sensors 916-924 include the air detection sensor 312, the fluid sensor 316, the anticoagulant air detection sensor 804, the pressure sensor 808, the line sensor 812, the second pressure sensor 816, and / or the air detection sensor 284.

[0059] Each of the cassette node 904 and the centrifuge node 908 may communicate with one or more pump drives, pump motors 936, 940, 944 (collectively referred to as pumps), etc. There may be more or fewer pumps than those shown in Figure 9, as indicated by the abbreviation 948. The cassette node 904 and / or the centrifuge node 908 can communicate with pumps 936-944 directly via wired or wireless communication, or via bus 932. Bus 932 may be a Control Area Network (CAN) bus, a Universal Serial Bus, or other type of bus architecture for communicating with pumps 936-944. Pumps 936-944 may include, or be part of, at least one of the draw pump 208, return pump 212, and / or anticoagulant pump 216.

[0060] Figure 6 shows an exemplary cassette node 904. As shown, in at least one exemplary embodiment, the cassette node 904 may include one or more of the following: a controller 1004, a memory 1008, a valve controller 1020, a communication interface 1016 for a controller area network bus, a communication interface 1012 for general-purpose asynchronous transmission and reception, and communication interfaces for other types of buses. It should be understood that, although not shown, the cassette node 904 may also include other hardware, firmware, and / or software.

[0061] The controller 1004 (also called the processor) may be any type of microcontroller, microprocessor, field-programmable gate array (FPGA), application-specific integrated circuit (ASIC), etc. An example of the controller 1004 may be the NK10DN512VOK10 microcontroller, manufactured and sold by N9P USA, Incorporated, which is a microcontroller unit with a 32-bit architecture. However, other types of controllers are also possible. In each example, the controller 1004 is configured to control and / or instruct other types of devices such as the first fluid control valve 320A, the second fluid control valve 320B, the intake fluid control valve 320C, the plasma flow control valve 286, the saline flow control valve 288, and / or pumps 936-944. Furthermore, the controller 1004 is configured to communicate with various sensors 916-924 or other devices to receive and / or send information regarding the function of the apheresis system 200.

[0062] Other examples of controller 1004 include Qualcomm® Snapdragon® 800 and 801, Qualcomm® Snapdragon® 610 and 615 with 4G LTE Integration and 64-bit computing, Apple® A7 processor with 64-bit architecture, Apple® M7 motion coprocessor, Samsung® Exynos® series, Intel® Core® processor family, Intel® Xeon® processor family, Intel® Atom® processor family, Intel Itanium® processor family, Intel® Core® i5-4670K and i7-4770K 22nm Haswell, Intel® Core® i5-3570K 22nm IvyBridge, AMD® FX® processor family, AMD® FX-4300, FX-6300, and FX-8350 32nm Vishera may include, but is not limited to, at least one of the following: AMD® Kaveri processors, ARM® Cortex®-M processors, ARM® Cortex-A and ARM926EJ-S® processors, or other industrial-equivalent processors, and may perform computer functions using any known or future-developed standard instruction sets, libraries, and / or architectures.

[0063] Memory 1008 may be random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), portable compact disk read-only memory (CD-ROM), optical memory, magnetic memory, any suitable combination thereof, or any other type of memory including other types of memory devices or memory units that store and provide instructions for programming and controlling the controller 1004. Memory 1008 may also provide all types of software or firmware for programming the functions of the controller 1004.

[0064] Controller 1004 can communicate with one or more valve controllers 1020. Each valve, such as the first fluid control valve 320A, the second fluid control valve 320B, the suction fluid control valve 320C, the plasma flow control valve 286, and / or the saline flow control valve 288, may be controlled by a valve controller 1020 and may be associated with a component of the system 200. A valve controller 1020 can supply electrical signals, operation commands, or power to close or open any one of the valves, for example, the saline / plasma valve housing 276, the plasma flow control valve 286, the saline flow control valve 288, the first fluid control valve 320A, the second fluid control valve 320B, and / or the suction fluid control valve 320C.

[0065] The controller 1004 can also be connected to buses 912 and 932 via transceivers 1012 and 1016 that are located outside the controller 1004 or are integrated with the controller 1004. The general-purpose asynchronous transceiver 1012 can communicate with one or more of the sensors 916 to 924 or other devices. Similarly, the control area network bus transceiver 1016 can communicate with one or more of the pump controllers 936 to 944 or other devices. The general-purpose asynchronous transceiver 1012 and bus, as well as the control area network bus transceiver 1016 and bus, are well known in the art and will not be described in detail herein.

[0066] Figure 7 shows an exemplary centrifuge node 908. The centrifuge node may include the same or similar types of components as the cassette node 904. For example, in at least one exemplary embodiment, as shown, the centrifuge node 908 may include a controller 1104 and / or a general-purpose asynchronous transceiver 1112. Similar to the controller 1004, in at least one exemplary embodiment, the controller 1104 may include any type of processor or microcontroller, for example, the NK10DN512VOK10 microcontroller unit with a 32-bit architecture provided by N9P USA, Incorporated.

[0067] In at least one exemplary embodiment, the controller 1104 is configured to communicate directly with sensors 916-924, for example, via a general-purpose asynchronous transceiver 1112 and / or via another bus or system. In at least one exemplary embodiment, the controller 1104 is configured to communicate with a brake controller 1124. The brake controller 1124 is configured to brake or decelerate and stop the centrifuge 400. In at least one exemplary embodiment, the controller 1104 is configured to communicate with a motor transceiver 1116. The motor transceiver 1116 may be configured to communicate with a motor power system or motor controller that functions to spin up or rotate the centrifuge 400 and / or control the speed setting or other functions of the centrifuge 400. In at least one exemplary embodiment, the controller 1104 is configured to communicate with a cuff controller 1120 that can change or set the pressure of a pressure cuff on the arm of the donor 102 during the apheresis process. In at least one exemplary embodiment, the controller 1104 is configured to communicate with a strobe light 1114, which can be any light flashing periodically in sync with the motor's rotational speed. This allows the operator of the apheresis system 200 to visually observe the operation of the filler 460. The controller 1104 communicates with the strobe 1114 to change the frequency of flashing and / or the intensity of the light of the strobe 1114.

[0068] Figure 8 is a flowchart illustrating an exemplary data entry process 1200 for initializing the apheresis system 200 shown in Figures 1-7. The data entry process 1200 ensures that a target amount or volume of plasma (or other blood components) is obtained based on donor information. In at least one exemplary embodiment, the data entry process 1200 also allows for the input of other information, such as bottle identification information and / or collection set information, so that the apheresis system 200 can record information about which bottle and / or collection set was used for which donor 102. The data entry process 1200 in Figure 8 begins in step 1202. In this step, the apheresis system 200 is powered on and ready to await a new donor 102.

[0069] In at least one exemplary embodiment, as shown in Figure 9, the apheresis system 200 may include an integrated identification reader (e.g., a radio-frequency identification (RFID) reader, a barcode reader, etc.) 1221. The integrated identification reader 1221 is configured to read a code (e.g., a radio-frequency identification tag, a barcode, etc.) associated with a particular donor 102 and to control and / or determine certain operating parameters of the apheresis system 200 according to the information received by the identification reader. That information and / or data may include, for example, biological information such as age, weight, height, hematocrit value, hemoglobin, donor history, and / or other information that may be relevant to the blood collection process. Referring again to Figure 8, the data entry process 1200 has a step 1203 of receiving donor-specific information. For example, the apheresis system 200 may be configured to receive donor-specific information by scanning a barcode, a quick-release code, or other type of image. For example, in at least one exemplary embodiment, donor 102 may use an identification card or other type of object which may include one or more of a barcode, a quick-release code, and / or wireless automatic identification. The identification card or other type of object is portable between blood collection sites, apheresis systems, and / or various locations. Donor-specific information is stored in or on the identification card or other type of object in the form of a nomogram, for example, a two-dimensional barcode. In this way, donor 102 can carry a single form of identification information between multiple blood collection sites, and at each blood collection site, it is possible to collect information about donor 102, such as the time since the last visit.

[0070] By scanning an identification card or other type of object, the apheresis system 200 can receive, or become capable of receiving, information and / or data about individual donors 102 without requiring further user input, for example, through a user interface. The apheresis system 200 can receive information, automatically verify data input, and evaluate the information without human input. The received information is used to make the blood collection process faster, safer, and of higher quality for the donor. For example, the information received from donor 102 can be used to determine whether donor 102 is eligible for the blood collection process and to determine specific settings required for the blood collection process (e.g., expected total plasma volume or other information).

[0071] In at least one exemplary embodiment, an identification card or other type of object may include information relating to the donor 102's weight and / or height and / or hematocrit and / or hemoglobin, which may be used alone or in combination to determine the amount or volume of plasma (or other blood components) that donor 102 can provide or donate. For example, as can be understood, a donor 102 having a first weight may, in some cases, be able to provide a first amount of plasma, while a donor 102 having a heavier second weight may be able to provide a second amount of plasma, which is greater than the first amount. Additionally or alternatively, the donor 102's body mass index may be used to determine the amount or volume of plasma (or other blood components) that donor 102 can provide or donate. When the apheresis system 200 receives information, it can use a graphical user interface (GUI) to adjust various settings and / or prompt one or more steps for a nurse, physician, or other user or operator of the apheresis system 200, according to the received information. These steps include starting and stopping operations according to a determined blood volume or event or a prior blood volume or event.

[0072] In at least one exemplary embodiment, the information stored or carried on the identification card or other type of object (e.g., in the form of a nomogram) is limited to information that the apheresis system 200 is permitted to collect (e.g., in accordance with privacy laws, health laws, etc.). In at least one exemplary embodiment, donor information and / or data that is not permitted to be collected by the apheresis system 200 is encrypted or locked so that the apheresis system 200 (more specifically, the integrated identification reader 1221) cannot read and / or retrieve the information and / or data being noted.

[0073] In at least one exemplary embodiment, the apheresis system 200 can transmit information and / or data (e.g., via the control system 900 and / or computer system 1627) to identification cards or other types of objects and / or to other systems (such as a local computer system) which can be read by other apheresis systems at the same or different blood collection locations. For example, the apheresis system 200 is configured to transmit information and / or data such as the blood collection results and / or the current weight of donor 102 and / or the date and / or time of previous blood collections and / or various other information. In at least one exemplary embodiment, the apheresis system 200 may include one or more computer systems. For example, as shown in Figure 10, the apheresis system 200 may include one or more computer systems 1627. The computer system 1627 may include, for example, a processor 1630, memory 1633, input / output devices 1636, one or more pump control systems 1639, one or more sensors 1642, and / or other suitable elements. The processor 1630 is configured to run software. The software may include firmware, applications, and / or an operating system that can manage the operation of the apheresis system 200. The computer system 1627 is configured to detect the start step 1202 of the apheresis system 200 and / or to send certain information and / or data to the server 1621 via a connection to the network 1618, as shown in Figure 11. In this way, the apheresis system 200 can communicate certain information and / or data (e.g., data logs, firmware version identifiers, and error logs) with a local system, such as a computer at the blood collection site, which is configured to communicate with the server 1621.

[0074] In at least one exemplary embodiment, after receiving donor-specific information and / or data, the apheresis system 200 is configured to confirm receipt of the information and / or data using a feedback system such as a graphical user interface (GUI) 1230, as shown in Figure 12. In this way, nurses, physicians, or other users or operators of the apheresis system 200 can quickly confirm whether the donor information and / or data has been properly entered into the apheresis system 200. In at least one exemplary embodiment, the feedback system may further, or alternatively, include a speaker configured to provide voice feedback.

[0075] Referring again to Figure 8, Method 1200 further includes step 1206 of identifying donor 102 using the received information and / or data. For example, in at least one exemplary embodiment, the apheresis system 200 (e.g., by the control system 900 and / or the computer system 1627) is configured to use the information and / or data received via the scanner 1221 to identify whether donor 102 is associated with any of the existing donor 102 identification information in the database and / or whether donor 102 is a new donor (step 1206).

[0076] Method 1200 further includes step 1209 of receiving information and / or data related to a blood component collection set used during the blood collection process. In at least one exemplary embodiment, the blood component collection set includes a soft cassette assembly, such as a soft cassette assembly 300. In at least one exemplary embodiment, the information and / or data associated with the blood component collection set may be received by the apheresis system 200 via a barcode, quick-release code, wireless auto-identification chip, and / or other type of scannable object that may be associated with the blood component collection set (step 1209). In at least one exemplary embodiment, each blood component collection set is affixed with a label or sticker, each containing a different barcode, quick-release code, wireless auto-identification chip, and / or other type of scannable object. By scanning the label or sticker on the blood component collection set, the apheresis system 200 can record in memory (shared in at least one embodiment with server 1621) which blood component collection set is being used in the current blood collection process. In this way, the apheresis system 200 can associate a donor with a selected blood component collection set. The data associated with the blood component collection set may include, for example, the manufacturing date and / or manufacturer identification information and / or various other information that may be useful for data processing purposes after blood collection is complete. In at least one exemplary embodiment, the data associated with the blood component collection set received through the scan (step 1209) may be used to determine the type of blood component collection set. The type of blood component collection set may be used by the apheresis system 200 to adjust one or more settings, such as flow rate or other information, during the blood collection process.

[0077] In at least one exemplary embodiment, after scanning a blood component collection set, the operator of the apheresis system 200 may receive confirmation that information has been received from the blood component collection set. For example, a graphical user interface 1230, as shown in Figure 12, may display information regarding whether data has been received from the blood component collection set. In at least one exemplary embodiment, instead of, or in addition to, displaying information via the graphical user interface 1230, the apheresis system 200 may emit an audible sound through one or more speakers or display lights of various colors to indicate that data has been received.

[0078] Referring again to Figure 8, in at least one exemplary embodiment, Method 1200 has a step 1212 of receiving data associated with a collection bottle. For example, in at least one exemplary embodiment, a collection bottle is required to initialize the apheresis system 200 for a new donor. After blood collection, the collection bottle is filled with the collected plasma (or other fluid). For data tracking purposes, the collection bottle is required to be associated with a donor and identification information of the plasma collection bottle is required to be recorded. Thus, the operator of the apheresis system 200 uses the apheresis system 200 to scan (e.g., printed or affixed) labels, stickers, or other items associated with the collection bottle. Having received information and / or data from the plasma collection bottle (step 1212), as detailed in the steps above, the apheresis system 200 may confirm the receipt of the data via the graphical user interface 1230 and / or speaker and / or light and / or other feedback systems.

[0079] Method 1200 includes step 1213 of determining and / or selecting one or more operating parameters of the plasma collection process using the received data and / or information (including donor-specific information and / or data, and / or blood component collection set information and / or data, and / or collection bottle information and / or data). For example, in at least one exemplary embodiment, the apheresis system 200 is configured (e.g., via a control system 900 and / or computer system 1627) to calculate the amount or volume of plasma (or other components) that donor 102 can provide or contribute, using the received information and / or data. For example, an exemplary method 600 for determining the amount or volume of plasma that donor 102 can provide or contribute is shown in Figure 13.

[0080] In at least one exemplary embodiment, method 600 measures the total blood volume (TBV) of an identified donor 102. i This includes step 610 of receiving or determining the initial total blood volume (also referred to as the donor's initial total blood volume).

[0081] In at least one exemplary embodiment, the total blood volume is determined using the LEMMENS formula shown below.

number

number

[0082] In other exemplary embodiments, the total blood volume is determined using the NADLER formula shown below.

number

number

[0083] Weight is the measured weight of donor 102. Height is the measured height of donor 102. In at least one exemplary embodiment, weight and / or height and / or body mass index are transmitted to the apheresis system 200 (and more specifically, the control system 900 and / or computer system 1627) via a donor identification card or other types of objects as discussed above and / or from inputs made by an operator, for example, via the graphical user interface 1230. The apheresis system 200 (and more specifically, the control system 900 and / or computer system 1627) is configured to determine the body mass index and / or receive a predetermined body mass index from, for example, a donor identification card or other types of objects and / or from inputs made by a nurse, physician, or other user or operator of the apheresis system 200, for example, via the graphical user interface 1230. The apheresis system 200 (more specifically, the control system 900 and / or the computer system 1627) calculates total blood volume (TBV) using, for example, the Lemmens formula and / or the Nadler formula. i The system is configured to determine the total blood volume, and / or to receive a predetermined total blood volume from, for example, a donor identification card or other type of object, and / or from input made, for example, via the graphical user interface 1230, by a nurse, physician, or other user or operator of the apheresis system 200.

[0084] Referring back to FIG. 13, method 600 has a step 620 of determining donor-specific component amounts. The step 620 of determining donor-specific component amounts may include using one or more of the relationships described below.

[0085] As shown below, the total blood volume (TBV i ) is equal to the sum of the final total blood volume (TBV f ) (the volume of the donor's total blood after blood collection), the amount of platelets collected (hereinafter referred to as the collected platelet amount; the same applies hereinafter) (the volume of the pure platelets collected in the plasma), the collected plasma volume (the volume of the pure plasma collected), and the collected red blood cell amount (the volume of the red blood cells collected at a hematocrit value of 100%) divided by the hematocrit value (hct dr ) of the collected red blood cells (usually about 80%).

Number

[0086] As shown below, the product of the total blood volume (TBV i ) and the donor's starting hematocrit value (hct i ) is equal to the sum of the product of the final total blood volume (TBV f ) and the donor's final hematocrit value (hct f ) and the collected red blood cell amount.

Number

[0087] The relationships (5) and (6) shown here may be combined to solve for various component amounts.

[0088] In at least one exemplary embodiment, the amount or volume of pure plasma to be collected is determined in step 620. The amount or volume of donor-specific pure plasma to be collected (i.e., platelets and red blood cells = 0) (the "collected plasma") is based on the determined or received total blood volume (TBV i ) and / or the starting hematocrit value (hct i) and / or the target change in the hematocrit value can be used to determine, for example, according to the following relationship:

number

number

number

number

number

number

[0089] Hematocrit value (hct i ) is the hematocrit value measured for donor 102 (i.e., the volume fraction of red blood cells in the blood in decimal form), and is transmitted to the apheresis system 200 (more specifically, the control system 900 and / or the computer system 1627) from input made by a nurse, physician, or other user or operator of the apheresis system 200 via a donor identification card or other type of object and / or, for example, via a graphical user interface 1230. The apheresis system 200 (more specifically, the control system 900 and / or the computer system 1627) is configured to perform plasma collection (step 1215) and / or to determine the amount or volume of donor-specific pure plasma to be collected (step 620) only if the hematocrit value is found to be within a predetermined threshold, for example, between approximately 0.38 and approximately 0.54.

[0090] The hematocrit value increases as plasma is removed from the donor. The target change in hematocrit value reflects this difference and is selected as a desired constant. The target change in hematocrit value is a constant value unique to the donor. This value may be received and / or generated and / or stored locally by the apheresis system 200 (more specifically, the control system 900 and / or the computer system 1627). In at least one exemplary embodiment, the target change in hematocrit value is transmitted to the apheresis system 200 (more specifically, the control system 900 and / or the computer system 1627) via the server 1621.

[0091] The target change in hematocrit value is selected so that the donor's hematocrit value after harvesting is an acceptable and safe hematocrit value, as determined, for example, by various regulatory mechanisms. In at least one exemplary embodiment, the target change in hematocrit value may be about 1% or more (e.g., about 1.5% or more, about 2% or more, about 2.5% or more, about 3% or more, about 3.5% or more, about 4% or more, about 4.5% or more, about 5% or more, about 5.5% or more, about 6% or more, about 6.5% or more, about 7% or more, about 7.5% or more, about 8% or more, about 8.5% or more, about 9% or more, about 9.5% or more, about 10% or more, about 10.5% or more, about 11% or more, about 11.5% or more, about 12% or more, about 12.5% ​​or more, about 13% or more, about 13.5% or more, about 14% or more, about 14.5% or more). In at least one exemplary embodiment, the target change in hematocrit value may be about 15% or less (for example, about 14.5% or less, about 14% or less, about 13.5% or less, about 13% or less, about 12.5% ​​or less, about 12% or less, about 11.5% or less, about 11% or less, about 10% or less, about 9.5% or less, about 9% or less, about 8.5% or less, about 8% or less, about 7.5% or less, about 7% or less, about 6.5% or less, about 6% or less, about 5.5% or less, about 5% or less, about 4.5% or less, about 4% or less, about 3.5% or less, about 3% or less, about 2.5% or less, about 2% or less, about 1.5% or less). In at least one exemplary embodiment, the target change in hematocrit value may be in the range of about 1% to about 15% (e.g., about 2% to about 14%, about 3% to about 13%, about 4% to about 12%, about 5% to about 11%, about 6% to about 10%, about 7% to about 9%). In at least one exemplary embodiment, the target change in hematocrit value may be about 8%.

[0092] In at least one exemplary embodiment, the amount or volume of pure red blood cells (i.e., platelets and plasma = 0) to be collected ("collected red blood cells") is determined in step 620. The amount or volume of donor-specific red blood cells to be collected is determined or the total blood volume received (TBV). i ) and / or initial hematocrit value (hct i Using this, for example, it is determined according to the following relationship.

number

number

number

number

number

number

number

[0093] Referring again to Figure 8, Method 1200 ends in step 1218, at which point the blood collection process may continue with the extraction of fluid from the donor complete. Any information and / or data received through the steps described above may be recorded in memory and / or shared with one or more computer systems 1627. For example, a database entry may be created for a particular blood collection to include information such as the amount or volume of plasma extracted from the donor, the donor's current weight, the time and / or date of the blood collection, and / or other information and / or data.

[0094] 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 using a medical system, the method is A step of receiving data associated with a subject by the medical system, wherein the data associated with the subject includes the subject's initial hematocrit value. A step of determining the amount of subject-specific pure components to be collected by the medical system, wherein the amount of subject-specific pure components to be collected by the medical system is determined using the subject's initial hematocrit value, the subject's initial total blood volume, and a target change in the hematocrit value. The steps include using the aforementioned medical system to perform a component collection process to collect the determined amount of the subject-specific pure component, Having, method.

2. In the method according to claim 1, the step of receiving the data associated with the subject includes the step of scanning an image using a scanner. method.

3. In the method according to claim 2, the scanner is located in the medical system. method.

4. In the method according to claim 2, the image includes a one-dimensional barcode, a two-dimensional barcode, or a combination of a one-dimensional barcode and a two-dimensional barcode. method.

5. The method according to claim 1, further, The steps include determining the identification of the subject using the data associated with the subject received by the medical system, The medical system includes the step of adjusting one or more parameters of the component collection process, Having, method.

6. The method according to claim 1, further, The medical system includes the step of receiving data associated with a blood component collection set, The medical system includes the step of adjusting one or more parameters of the component collection process, Having, method.

7. The method according to claim 1, further, The medical system includes the steps of receiving data associated with the ingredient collection bottle, The medical system includes the step of adjusting one or more parameters of the component collection process, Having, method.

8. In the method according to claim 1, the data associated with the subject further includes the total blood volume, method.

9. The method according to claim 1, further, The medical system has the step of determining the total blood volume of the subject using the data associated with the subject that has been received, method.

10. The method according to claim 9, further, The medical system has the step of determining the body mass index of the subject using the data associated with the subject that has been received. method.

11. In the method according to claim 1, the target change in the hematocrit value is a constant selected in advance from a range of about 1% to about 15%. method.

12. In the method according to claim 1, the target change in the hematocrit value is selected based on the subject's initial hematocrit value and the acceptable hematocrit value after component sampling. method.

13. In the method according to claim 12, the difference between the subject's initial hematocrit value and the acceptable hematocrit value after component sampling is in the range of approximately 1% to approximately 15%. method.

14. In the method according to claim 11, the target change in the hematocrit value is about 8%. method.

15. The method according to claim 1, wherein the amount of the subject-specific pure component comprises only plasma, and the amount of the subject-specific pure component to be collected by the medical system is determined by the medical system according to the following relationship. [Math 1] Here, TBV ｉ This is the total blood volume of the subject at the start of the process, and hct ｉ This is the hematocrit value of the subject at the start of the process.

16. The method according to claim 1, further, The process includes, after receiving the data associated with the subject, a step of confirming receipt of the data using a feedback system. method.

17. In the method according to claim 16, the feedback system includes a speaker, a graphical user interface, or a speaker combined with a graphical user interface. method.

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