Method and system for determining subject-specific quantity for acquisition

Abstract

A method for acquiring a blood component using a medical system includes: receiving, by the medical system, data associated with an individual subject, the data associated with the individual subject including an initial hematocrit of the subject; identifying, by the medical system, a subject-specific pure component amount to be collected by the medical system, the subject-specific pure component amount to be collected by the medical system being determined using a hematocrit of the subject, a total blood volume of the subject, and a target change in hematocrit; and performing, using the medical system, a component donation process to acquire the identified subject-specific pure component to be acquired.

Description

Cross-reference to related applications

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

[0002] This disclosure relates generally to the separation of components in a multi-component fluid, and more particularly to single-component methods and systems. Background Technology

[0003] This section provides background information in connection with this disclosure, which is not necessarily prior art.

[0004] There are two common methods of blood donation / collection. The first common method involves obtaining 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 different densities of the blood components. During and / or after the application of centrifugation, the desired components can be moved manually, semi-automatically, or automatically into a collection container. The second common method, known as apheresis, requires specialized equipment. For example, the apheresis method extracts whole blood from a donor while the donor is connected to a specialized apheresis device. The whole blood can then be centrifuged to collect only the desired blood components (e.g., plasma, platelets), and all other blood components are returned to the donor during the same donation connection or cycle. During the separation and collection of blood components, the donor is connected to the apheresis machine. The safe and acceptable collection volume for separation can be determined in response to certain characteristics specific to the donor, including, for example, height, weight, hematocrit, and / or hemoglobin. Summary of the Invention

[0005] This section provides a general overview of this disclosure and is not a full disclosure of its entire scope or all its features.

[0006] This disclosure provides a method for collecting blood components using a medical system.

[0007] In at least one exemplary embodiment, the method may include: receiving data associated with an individual subject via a medical system, the data associated with the individual subject including the subject's initial hematocrit; identifying, via the medical system, a subject-specific pure component quantity to be collected via the medical system, the subject-specific pure component quantity to be collected via the medical system being determined using the subject's initial hematocrit, the subject's initial total blood volume, and a target change in hematocrit; and using the medical system, performing a component donation process to collect the identified subject-specific pure component quantity to be collected.

[0008] In at least one exemplary implementation, receiving data associated with an individual subject may include scanning images with a scanner.

[0009] In at least one exemplary embodiment, the scanner may be mounted on a 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 one-dimensional and two-dimensional barcodes.

[0011] In at least one exemplary embodiment, the method may further include: identifying the subject using received data associated with an individual subject through a medical system; and adjusting one or more parameters of the component donation process through the medical system.

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

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

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

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

[0016] In at least one exemplary embodiment, the method may further include: determining the subject's body mass index using received data associated with an individual subject through a medical system.

[0017] In at least one exemplary embodiment, the target change in hematocrit can be a preselected constant ranging from about 1% to about 15%.

[0018] In at least one exemplary implementation, the target change in hematocrit can be selected based on the subject’s initial hematocrit and an acceptable post-hematocrit level.

[0019] In at least one exemplary embodiment, the difference between the subject’s initial hematocrit and the acceptable post-hematocrit level can range from about 1% to about 15%.

[0020] In at least one exemplary embodiment, the target change in hematocrit can be about 8%.

[0021] In at least one exemplary embodiment, the subject-specific pure component amount includes only plasma, and the subject-specific pure component amount to be collected by the medical system can be determined by the medical system according to the following relationship: ; Among them, TBV i (initial total blood volume) is the subject's initial total blood volume, and hct i (initial hematocrit) is the initial hematocrit of the subject.

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

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

[0025] The accompanying drawings described herein are for illustrative purposes only, and not for all possible implementations, and are not intended to limit the scope of this disclosure.

[0026] Figure 1 This is a perspective view of the operating environment of an exemplary single-sample system according to at least one exemplary embodiment; Figure 2 According to at least one exemplary implementation, in Figure 1 The diagram shows a perspective view of an exemplary single-sample system, with the access door in the closed position. Figure 3 According to at least one exemplary implementation, in Figures 1 to 2 The diagram shows a perspective view of an exemplary single-sample system, with the access door in the open position, exposing the centrifuge assembly. Figure 4 According to at least one exemplary implementation, in Figures 1 to 3 Functional diagram of an exemplary implementation of an exemplary single-sample system shown; Figure 5 According to at least one exemplary implementation, in Figures 1 to 4 A block diagram of an exemplary electrical system for an exemplary single-sample system shown in the figure; Figure 6 According to at least one exemplary implementation, in Figures 1 to 5 Another block diagram of the exemplary electrical system of the exemplary single-sample system shown; Figure 7 According to at least one exemplary implementation, in Figures 1 to 5 Another block diagram of the exemplary electrical system of the exemplary single-sample system shown; Figure 8 According to at least one exemplary embodiment, the use in Figures 1 to 7 A flowchart of an exemplary method of a single-sample system shown; Figure 9 According to at least one exemplary implementation, in Figures 1 to 8 The diagram also includes a perspective view of an exemplary single-scan system for the scanner; Figure 10 According to at least one exemplary implementation, in Figures 1 to 9 A block diagram of an exemplary computing system for an exemplary single-collection system shown in the figure; Figure 11 The diagram illustrates a connection to a network according to at least one exemplary embodiment. Figures 1 to 10 The exemplary single-collection system shown; Figure 12 It is shown that, according to at least one exemplary embodiment, in Figures 1 to 10 An exemplary graphical user interface of the exemplary single-sample system shown; and Figure 13 This is a flowchart illustrating an exemplary method for determining a specific amount or volume of pure plasma from a donor to be collected, according to at least one exemplary embodiment.

[0027] The corresponding reference numerals indicate the corresponding parts of the multiple illustrations in all the figures. Detailed Implementation

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

[0029] The exemplary embodiments provided are intended to make this disclosure comprehensive and to fully convey the scope to those skilled in the art. Numerous specific details, such as examples of specific components, apparatus, and methods, are set forth to provide a comprehensive understanding of embodiments of this disclosure. It will be apparent to those skilled in the art that specific details are not required, that exemplary embodiments may be implemented in many different forms, and that neither should be construed as limiting the scope of this disclosure. In some exemplary embodiments, well-known processes, well-known apparatus structures, and well-known technologies are not described in detail.

[0030] The terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. As used herein, the singular forms “a,” “an,” and “the” may also be intended to include the plural forms unless the context clearly indicates otherwise. The terms “comprises,” “comprising,” “including,” and “having” are inclusive and thus specify the presence of the stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. Unless the order in which they are performed is explicitly specified, the method steps, processes, and operations described herein should not be construed as requiring them to be performed in the specific order discussed or shown. It should also be understood that additional or alternative steps may be employed.

[0031] When an element or layer is referred to as “located in,” “joined to,” “connected to,” or “coupled to” another element or layer, it may be directly located in, joined to, connected to, or coupled to the other element or layer, or there may be intermediate elements or layers present. Conversely, when an element is referred to as “directly located in,” “directly joined to,” “directly connected to,” or “directly coupled to” another element or layer, there may be no intermediate elements or layers present. Other terms used to describe relationships between elements should be interpreted in a similar manner (e.g., “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 associated listed items.

[0032] Although the terms “first,” “second,” “third,” etc., may be used herein to describe various elements, components, regions, layers, and / or portions, these elements, components, regions, layers, and / or portions should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or portion from another. Unless the context clearly indicates otherwise, terms such as “first,” “second,” and other numerical terms used herein do not imply order or sequence. Therefore, without departing from the teachings of the exemplary embodiments, the first element, component, region, layer, or portion discussed below may be referred to as the second element, component, region, layer, or portion.

[0033] For ease of description, spatial relative terms such as “inner,” “outer,” “beneath,” “below,” “lower,” “above,” and “upper” are used herein to describe the relationship between one element or feature and another, as shown in the figures. In addition to the orientations depicted in the figures, spatial relative terms may be intended to cover different orientations of the device in use or operation. For example, if the device in the figure is flipped, an element described as “below” or “below” other elements or features would then be oriented “above” other elements or features. Thus, the exemplary term “below” can cover both above and below orientations. The device may be oriented in other ways (rotated 90 degrees or otherwise), and the spatially related descriptive terms used herein will be interpreted accordingly.

[0034] In this document, various components are referred to as “operably associated.” As used herein, “operably associated” means components that are operably connected together, and encompasses embodiments in which components are directly connected, as well as embodiments in which additional components are placed between the connected components. “Operably associated” components can be “fluidly associated.” “Fluidally associated” means that components are connected together such that fluid can be transported between them. “Fluidally associated” encompasses embodiments in which additional components are disposed between two fluidly associated components, as well as embodiments between directly connected components. Fluidly associated components may include components that do not contact the fluid but contact other components to operate the system (e.g., 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 term "module" or "controller" may be replaced by the term "circuit". The term "module" may refer to or include the following: Application Specific Integrated Circuit (ASIC); 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 circuitry (shared, dedicated, or grouped) that executes code; (shared, dedicated, or grouped) memory circuitry that stores code executed by the processor circuitry; other suitable hardware components that provide the aforementioned functionality; or combinations of some or all of the above, such as in a system-on-a-chip.

[0036] A module may include one or more interface circuits. In some examples, the interface circuits may include wired or wireless interfaces that connect to a local area network (LAN), the Internet, a wide area network (WAN), or a combination thereof. The functionality of any given module disclosed herein can be distributed among multiple modules connected via the interface circuits. For example, multiple modules can allow for load balancing. In yet another example, a server (also referred to as a remote or cloud) module may perform some functions on behalf of a client module.

[0037] As used above, the term "code" can include software, firmware, and / or microcode, and can refer to programs, routines, functions, classes, data structures, and / or objects. The term "shared processor circuitry" covers a single processor circuitry that executes some or all of the code from multiple modules. The term "group processor circuitry" covers a processor circuitry that, in combination with additional processor circuitry, executes some or all of the code from one or more modules. References to multiple processor circuitry cover multiple processor circuitry on a discrete die, multiple processor circuitry on a single die, multiple cores of a single processor circuitry, multiple threads of a single processor circuitry, or a combination of the above. The term "shared memory circuitry" covers a single memory circuitry that stores some or all of the code from multiple modules. The term "group memory circuitry" covers a memory circuitry that, in combination with additional memory, stores some or all of the code from one or more modules.

[0038] The term "memory circuit" is a subset of the term "computer-readable medium." As used herein, the term "computer-readable medium" does not cover transient electrical or electromagnetic signals propagating through a medium (such as on a carrier wave); therefore, the term "computer-readable medium" can be considered tangible and non-transient. Non-limiting examples of non-transient tangible computer-readable media are non-volatile memory circuits (such as flash memory circuits, erasable programmable read-only memory circuits, or masked 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 tape, 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 can be implemented, in part or in whole, by a dedicated computer created by configuring a general-purpose computer to execute one or more specific functions contained in a computer program. The aforementioned function blocks, flowchart components, and other elements serve as software specifications that can be translated into a computer program through the routine work of a skilled technician or programmer.

[0040] A computer program includes processor-executable instructions stored on at least one non-transitory 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) for interacting with the hardware of a special-purpose computer, device drivers for interacting with specific devices of the special-purpose computer, one or more operating systems, user applications, background services, background applications, etc.

[0041] Computer programs may include: (i) descriptive text to be parsed, such as HTML (hypertext markup language), XML (extensible markup language), or JSON (JavaScript Object Notation); (ii) assembly code; (iii) object code generated from source code by a compiler; (iv) source code executed by an interpreter; and (v) source code compiled and executed by a just-in-time (JIT) compiler, etc. As an example only, source code may be written using syntax from 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 Edition), Ada, ASP (Active Server Pages), PHP (Hypertext Preprocessor), Scala, Eiffel, Smalltalk, Erlang, Ruby, Flash®, Visual Basic®, Lua, MATLAB, SIMULINK, and Python®.

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

[0043] This disclosure relates to methods and apparatus 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 apheresis systems, such as those described in: U.S. Patent No. 11,090,425, entitled "Method and System for High-Throughput Blood Component Collection," issued August 17, 2021; U.S. Application No. 18 / 117,035, entitled "Soft Box with Integrated Features," filed March 3, 2023; U.S. Application No. 18 / 116,919, entitled "Blood Component Collection Bag," filed March 3, 2023; U.S. Application No. 18 / 117,077, entitled "Integrated Code Scanning System and Method for Apheresis Data Control," filed March 3, 2023; and U.S. Application No. 18 / 117,044, entitled "Calibration, Maintenance, and..." for apheresis systems. U.S. Patent Application No. 18 / 116,902, entitled "Methods and Systems for Maintenance", filed March 3, 2023; U.S. Patent Application No. 18 / 116,958, entitled "Bottle Tray with Magnetic Coupling and Weighing Sensor Overload Protection", filed March 3, 2023; U.S. Patent Application No. 18 / 116,988, entitled "Communication and Operation Control of Apheresis Systems", filed March 3, 2023; U.S. Patent Application No. 18 / 117,006, entitled "Methods and Interfaces for Providing Feedback on the Donation Process", filed March 3, 2023; U.S. Patent Application No. 18 / 117,007, entitled "Modular Serviceability Sleds and Interconnects". U.S. Patent Application No. 18 / 116,908, entitled "Collection Bottle with Integrated Cap, Handle, and Cover Features", filed March 3, 2023; U.S. Patent Application No. 18 / 116,992, entitled "Method for Providing Automatic Flow Regulation", filed March 3, 2023; U.S. Patent Application No. 18 / 116,999, entitled "Safety Features of a Single Collection System", filed March 3, 2023; U.S. Patent Application No. 18 / 117,029, entitled... The following U.S. patent applications were filed on March 3, 2023: “Automatic Operation Control Based on Detected Environmental Conditions”; U.S. Patent Application No. 18 / 116,954, entitled “Sensor Based on Bending Pipe Conditions”; U.S. Patent Application No. 18 / 117,035, entitled “Soft Box with Integrated Features”; and U.S. Patent Application No. 18 / 117,073, entitled “Blood Component Collection Device with Integrated Safety Features”; all of the disclosures of these applications are incorporated herein by reference.

[0044] Apheresis systems typically include one or more connectors configured to move whole blood and / or blood fractions to and from a blood fractionation device housed within the apheresis system, wherein the blood fractionation device is a centrifuge. For example... Figure 1 This is a perspective view of the operating environment 100 of an apheresis system 200 according to at least one exemplary embodiment of the present disclosure. The operating environment 100 may include the apheresis system 200, a subject or donor or source 102, and one or more connectors (e.g., donor supply tubing 104, inlet tubing 108A, anticoagulant (AC) tubing 110, etc.) extending from the donor 102 to the apheresis system 200 and / or from the apheresis system 200 to the donor 102. The donor supply tubing 104 may be fluidly connected to at least one vessel (e.g., a vein) of the donor 102 via venipuncture. For example, a cannula connected to the end of the donor supply tubing 104 may pass through the skin of the donor 102 and be inserted into a target site or vein. This connection may provide an intravenous pathway for blood to flow from the donor 102 to the apheresis system 200 and / or for blood components to flow back to the donor 102. Whole blood supplied from donor 102 may flow along donor supply tubing 104 through tubing connector 106 and into cartridge assembly 300 along cartridge inlet tubing 108A. Cartridge assembly 300 may include one or more fluid control paths and valves for selectively controlling blood inflow and / or outflow from donor 102. Apheresis system 200 may include an anticoagulant supply contained in anticoagulant bag 114. Anticoagulant may be pumped at least through anticoagulant tubing 110 and tubing connector 106 to prevent blood from clotting in apheresis system 200.

[0045] Figure 2 yes Figure 1The image shows a perspective view of the apheresis system 200 described herein. The apheresis system 200 provides a continuous whole blood separation process. In at least one exemplary embodiment, whole blood can be drawn from donor 102 and supplied substantially continuously to a blood component separation device of the apheresis system 200, in which blood can be separated into various components, and at least one of these blood components can be collected from the apheresis system 200. In at least one exemplary embodiment, one or more of the separated blood components can be collected for subsequent use or returned to donor 102. Blood can be drawn from donor 102 and guided through an opening 220 in the access plate 224 of the apheresis system 200 into a centrifuge of the apheresis system 200. In at least one exemplary embodiment, in the tubing used in the extracorporeal tubing, donor supply tubing 104, box inlet tubing 108A, inlet tubing 108B (also referred to herein as loop inlet tubing 108B), outlet tubing 112 (also referred herein as loop outlet tubing 112), saline tubing 116 and plasma tubing 120 may be collectively defined in a closed, sterile and disposable system or blood component collection device, which may be further described below.

[0046] The operation of various pumps, valves, and blood component separation devices (e.g., centrifuges) can be controlled by one or more processors included in the apheresis system 200, and may advantageously include multiple embedded computer processors as part of a computer system. The computer system may also include components that allow users to interact with the computer system, including, for example, memory and storage devices (RAM, ROM (e.g., CD-ROM, DVD), magnetic drives, optical disc drives, flash memory, etc.); communication / networking devices (e.g., wired such as modems / network cards, or wireless such as Wi-Fi); input devices such as keyboards, touchscreens, cameras, and / or microphones; and output devices such as displays and audio systems. Although not shown, it should be understood that in at least one exemplary embodiment, to assist the operator of the apheresis system 200 in performing various aspects of its operation, the blood component separation device (e.g., centrifuge) may include a graphical user interface with a display, including an interactive touchscreen.

[0047] The single-collection system 200 may include a housing 204 and / or a structural frame, a cover 210, an access plate 224 disposed at the front 202 and / or rear 206 of the single-collection system 200, and one or more support members 232A-232C, the support members 232A-232C including hooks, brackets, supports, arms, protrusions, plates and / or other support structures for holding, suspending and / or otherwise supporting containers or anticoagulant bags 114, saline bags 118 or plasma collection bottles 122. The housing 204 may include a machine frame (e.g., made of welded, bolted and / or connected structural elements, extruded materials and / or beams), wherein one or more plates (such as cover 210), doors, sub-assemblies and / or components are attached to the machine frame. In at least one exemplary embodiment, at least one plate of the single-donor system 200 may include a mounting surface for the soft cartridge assembly 300, one or more pumps (such as suction pump 208, return pump 212, anticoagulant pump 216) and / or fluid valve control system 228 (e.g., plasma and saline valve control).

[0048] Access plate 224 may include one or more handles, locks, and pivoting or hinged shafts 226 (e.g., door hinges, piano hinges, continuous hinges, cleanroom hinges, etc.). Access plate 224 may be selectively opened to provide access to the interior of the blood collection system 200, and more specifically, to blood separation components (e.g., centrifuge components). For example, access plate 224 may provide access to loading and / or unloading a centrifuge having one or more components in a blood component collection device. In at least one exemplary embodiment, the interior of the blood collection system 200 may be divided into at least a centrifuge section and a control section. For example, the centrifuge section may include 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 section (e.g., configured to house or otherwise include a motor controller, CPU or processor, electronics, and / or wiring) may be provided by a robustly fixed panel of housing 204 and / or a plate separate from access plate 224.

[0049] In at least one exemplary embodiment, the apheresis system 200 may include multiple pumps, such as a suction pump 208, a return pump 212, and / or an anticoagulant pump 216, which may be configured to control the flow of fluids (e.g., blood and / or blood components, anticoagulant, and / or saline) through the apheresis system 200. Figure 2As shown, in at least one exemplary embodiment, the aspiration pump 208, the return pump 212, and / or the AC pump 216 may be at least partially disposed on the top of the cap 210 of the apheresis system 200. In at least one exemplary embodiment, the aspiration pump 208 may control the flow of blood to the donor 102 and / or from the donor 102 into the centrifuge of the apheresis system 200. For example, the aspiration pump 208 may engage a portion of the loop inlet pipe 108B, which is disposed between the cartridge assembly 300 and the centrifuge of the apheresis system 200. In at least one exemplary embodiment, the return pump 212 may be configured to control the flow of separated blood components (e.g., plasma) from the centrifuge to the plasma collection bottle 122 and / or from the plasma collection bottle 122 to the centrifuge. Additionally or alternatively, the return pump 212 may control the flow of saline (e.g., saline supplied from the saline bag 118) through the blood component collection device and / or the apheresis system 200. In at least one exemplary embodiment, the anticoagulant pump 216 may be partially engaged with the anticoagulant tube 110 to selectively control the flow of anticoagulant through the blood component collection device of the apheresis system 200.

[0050] Figure 3 An exemplary centrifuge assembly 400 for use with or in use within a single-collection system 200, according to at least one exemplary embodiment of the present disclosure, is illustrated. For example, the centrifuge assembly 400 may be disposed within the internal space of the single-collection system 200. The internal space may be at least partially surrounded by a housing 204 and / or one or more elements of a centrifuge chamber. Access to the internal space and the centrifuge assembly 400 may be provided via an access plate 224 disposed at the front 202 of the single-collection system 200. For example, in Figure 4 In A, the access panel 224 is shown in the open position, opened along the hinge axis 226. The hinge axis 226 may correspond to a door hinge, a continuous hinge, a cleanroom hinge, and / or some other panel hinge.

[0051] Centrifuge assembly 400 can be operably mounted inside single-sampling system 200, allowing assembly 400 to rotate relative to housing 204 and / or other components of single-sampling system 200. This is achieved by rotating pipes (e.g., inlet pipe 108B and / or outlet pipe 112) (e.g., via...) Figure 2The opening 220 shown introduces into the internal space of the apheresis system 200, connects a portion of the blood component collection circuit 520 to the fixed circuit connector 402, and inserts the blood component collection bladder 536 into the filler 460. The centrifuge assembly 400 may house one or more portions of the blood component collection device. The fixed circuit connector 402 holds the inlet tube 108B and outlet tube 112 in a fixed position and prevents the tubes 108B, 112 from twisting outside the apheresis system 200. In at least one exemplary embodiment, the blood component collection circuit may be interconnected with the fixed circuit connector 402 via one or more keying features or positive positioning features.

[0052] Figure 4 Provided in Figures 1 to 3 The diagram shows the function of the single-collection system 200. Figure 4 The components, as previously described in the functional diagram, are shown to illustrate the operation of system 200 for extracting plasma or other blood components from whole blood of donor 102 during apheresis procedures or processes. For example, as... Figure 4 As shown, 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 may also include an anticoagulant air detection sensor (ADS) 804, configured to detect air or fluid within the anticoagulant tube 110. The anticoagulant tube 110 may intersect and fluidly associate with the donor supply tube 104 and the cartridge inlet tube 108A at a tube connector 106. The tube connector 106 may be any type of connector configured to connect the different tubes 110, 104, and / or 108A.

[0053] A donor supply tube 104 extends from a donor 102, where the donor 102 can be inserted by a luminal needle or other device to allow whole blood to flow from the donor 102 into the apheresis system 200 and to allow blood components to flow back to the donor 102. A tube 108A can be connected to a flexible cartridge 340. In at least one exemplary embodiment, a donor air detection sensor (ADS) 312 can be placed on or within the tube 108A. The donor air detection sensor can be configured to detect the presence of fluid and / or air within the tube 108A.

[0054] The flexible cartridge 340 may include a first cartridge port 360A, where the tube 108A is divided into a first tube segment and a second tube segment. For example, the first cartridge port 360A may serve as a “Y” connector or branch that includes and / or substantially approaches the tube 108A into a first bypass branch 358A and a first tube segment 368A. The two tube segments may be reconnected at a second cartridge port 360B, which, like the first cartridge port 360A, may serve as a “Y” connector or section that includes and / or substantially approaches. In at least one exemplary embodiment, the first tube may be divided in two 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 second tube may be divided in two by a drip chamber 354 to form a first tube segment 368A and a second tube segment 368B. The infusion chamber 354 can be configured to collect a volume of whole blood and / or high hematocrit blood (blood with a high percentage of red blood cells) depending on the operation of the system 200. In at least one exemplary embodiment, the first tubing segment 368A may include a second fluid control valve 320A, and the second tubing segment 368B may include a third fluid control valve 320B. Fluid control valves 320A, 320B, and 320C may be configured to separate different tubing segments 358A, 368A, 358B, and 368B.

[0055] Inlet pipe 108B can be connected to second housing port 360B, and can connect flexible housing 340 to flexible circuit 524. In at least one exemplary embodiment, inlet pipe 108B may include sensor 808 disposed on or within pipe 108B prior to system static circuit connector 528 of flexible circuit 524. In at least one exemplary embodiment, inlet pipe 108B may include pressure sensor (CPS) 808 disposed between second housing port 360B and system static circuit connector 528. In each example, suction pump 208 may be configured to pump fluid through pipe 108B out of or into flexible housing 340.

[0056] Two or more distinct tubes may be connected to the flexible circuit 524 via the system static loop connector 528 and may supply or receive fluid to or from the blood component collection sac 536. In at least one exemplary embodiment, the outlet tube 112 may be connected to the flexible circuit 524 via the system static loop connector 528. In at least one exemplary embodiment, the outlet tube 112 may include another wire sensor 812 disposed thereon or therein, configured to detect fluid, air, cell concentration, color, and / or color changes in the fluid moving from the flexible circuit 524. In at least one exemplary embodiment, a second pressure sensor or fluid sensor 816 may also be disposed in or on the line 112. The sensor 816 may be configured to detect the presence or absence of fluid within the outlet tube 113, the pressure within the outlet tube 112, and / or one or more other characteristics of the fluid in the outlet tube 112. In each example, before the saline and plasma tube Y-connector 280 splits the outlet tube 112 into the saline tube 116 and the plasma tube 120, the outlet tube 112 may flow into the plasma air detection sensor 284. In at least one exemplary embodiment, the reflux pump 212 may be engaged with the outlet pipe 112 to allow fluid or air to flow either from the flexible circuit 524 or from the saline bag 118 and / or the plasma collection bottle 122 through the outlet pipe 112.

[0057] Figure 5 The configuration for control is shown. Figures 1 to 4The illustrated example is an electrical and control system 900 for the functionality of the blood collection system 200. Generally, the control system 900 may include one or more nodes, which may include various hardware, firmware, and / or software configured to control and / or communicate with the mechanical, electromechanical, and electrical components of the blood collection system 200. Each node may be configured to control different parts of the blood collection system 200. For example, the control system 900 may include a box node 904, which may be a soft-box assembly system configured to control and / or communicate with components of the blood component collection device (and / or associated hardware or mechanical components connected to the blood component collection device or its components). Centrifuge node 908 may be a centrifuge system configured to control centrifuge assembly 400 (and / or associated hardware or mechanical components associated with centrifuge assembly 400 or its components) and / or communicate with centrifuge assembly 400 (and / or associated hardware or mechanical components associated with centrifuge assembly 400 or its components). In at least one exemplary embodiment, cassette node 904 and centrifuge node 908 may communicate with each other wirelessly or via some other electrical or data connection. In at least one exemplary embodiment, cassette node 904 and centrifuge node 908 may be divided into a single node or part of system 902. In at least one exemplary embodiment, cassette node 904 and centrifuge node 908 may have the same or different physical hardware for operating and / or controlling different functions.

[0058] Each of the box node 904 and centrifuge node 908 can communicate with one or more sensors 916, 920, and / or 924. (The last sentence appears to be incomplete and possibly refers to a different topic.) Figure 9The sensors shown may include more or fewer sensors, as indicated by ellipsis 928. Each of the box node 904 and / or centrifuge node 908 may communicate directly with each of the sensors 916-924, or in other embodiments, each of the box node 904 and / or centrifuge node 908 may communicate with several sensors 916-924 via bus 912. Bus 912 may communicate via any type of communication protocol, such as universal serial bus (USB), universal asynchronous receive / transmit (UART), or other types of bus systems or parallel communication connections. Sensors 916-924 may be any type of sensor capable of transmitting information such as the presence of light, fluid, air, color, and / or pressure. Some of the sensors 916-924 may include sensors such as: air detection sensor 312, fluid sensor 316, anticoagulant air detection sensor 804, pressure sensor 808, pipeline sensor 812, second pressure sensor 816 and / or air detection sensor 284.

[0059] Each of the box node 904 and centrifuge node 908 can communicate with one or more pump drivers, pump electrodes 936, 940, 944 (collectively, the "pump"). More than... Figure 9 The pumps shown may include more or fewer pumps, as indicated by ellipsis 948. Box node 904 and / or centrifuge node 908 may communicate with pumps 936-944 via direct wired or wireless communication or via bus 932. Bus 932 may be a control area network (CAN) bus, universal serial bus, or other type of bus architecture for communication with pumps 936-944. Pumps 936-944 may include at least one of suction pump 208, return pump 212, and / or anticoagulant pump 216, or at least a portion of suction pump 208, return pump 212, and / or anticoagulant pump 216.

[0060] Figure 6 An exemplary box node 904 is shown. As illustrated, in at least one exemplary embodiment, box node 904 may include one or more of a controller 1004, a memory 1008, a valve controller 1020, a communication interface for a control area network bus 1016, a communication interface for a universal asynchronous receive / transmit 1012, and a communication interface for other types of buses. Although not shown, it should be appreciated that box node 904 may also include other hardware, firmware, and / or software.

[0061] The controller 1004, also referred to as a processor, can be any type of microcontroller, microprocessor, field-programmable gate array (FPGA), application-specific integrated circuit (ASIC), etc. An exemplary controller 1004 could 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 manage the functions of other types of devices (such as valves, 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, the saline flow control valve 288, and / or pumps 936-944). The controller 1004 can also be configured to communicate with various sensors 916-924 or other devices to receive and / or send information about the functionality of the single-collection system 200.

[0062] Other examples of controller 1004 may include, but are not limited to, at least one of the following: 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 series, Intel® Xeon® processor series, Intel® Atom™ processor series, Intel Itanium® processor series, Intel® Core® i5-4670K and i7-4770K 22nm Haswell, Intel® Core® i5-3570K 22nm Ivy Bridge, AMD® FX™ processor series, AMD® FX-4300, FX-6300 and FX-8350 32nm Vishera, AMD® Kaveri processor, ARM® Cortex™-M processor, ARM® Cortex-A and ARM926EJ-S™ processors, other industrial equivalent processors, and can perform computing functions using any known or future-developed standards, instruction sets, libraries, and / or architectures.

[0063] The memory 1008 can be any type of memory, including random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), portable optical disc read-only memory (CD-ROM), optical storage device, magnetic storage device, any suitable combination of the foregoing, or other types of storage or memory device that stores and provides instructions to program and control the controller 1004. The memory 1008 can 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. Valves, such as a first fluid control valve 320A, a second fluid control valve 320B, a suction fluid control valve 320C, a plasma flow control valve 286, and / or a saline flow control valve 288, can be controlled by valve controller 1020 and can be associated with components of system 200. Valve controller 1020 can provide electrical signals, operating commands, or power to close or open any of the valves, such as saline and plasma valve housings 276, plasma flow control valve 286, saline flow control valve 288, first fluid control valve 320A, second fluid control valve 320B, and / or suction fluid control valve 320C.

[0065] Controller 1004 can also be connected to buses 912 and 932 via transceivers 1012 and 1016 located externally to or integrated into controller 1004. Universal Asynchronous Receiver / Transmitter 1012 can communicate with one or more of sensors 916-924 or other devices. Similarly, Control Area Network (CAN) bus transceiver 1016 can communicate with one or more of pump controllers 936-944 or other devices. Universal Asynchronous Receiver / Transmitter 1012 and the bus, as well as Control Area Network (CAN) bus transceiver 1016 and the bus, are well known in the art and do not require further explanation herein.

[0066] Figure 7 An exemplary centrifuge node 908 is illustrated. The centrifuge node may include components of the same or similar type as the box node 904. For example, as shown, in at least one exemplary embodiment, centrifuge node 908 may include controller 1104 and / or universal asynchronous receiver / transmitter transceiver 1112. Similar to controller 1004, in at least one exemplary embodiment, controller 1104 may include any type of processor or microcontroller, including, for example, the NK10DN512VOK10 microcontroller unit with a 32-bit architecture from N9PUSA Incorporated.

[0067] In at least one exemplary embodiment, controller 1104 may be configured to communicate directly with sensors 916-924, for example, via a universal asynchronous receiver / transmitter 1112 and / or via other buses or systems. In at least one exemplary embodiment, controller 1104 may be configured to communicate with brake controller 1124. Brake controller 1124 may be configured to brake or slow down and stop centrifuge 400. In at least one exemplary embodiment, controller 1104 may be configured to communicate with motor transceiver 1116. Motor transceiver 1116 may be configured to communicate with a motor power system or motor controller that functions to start or rotate centrifuge 400 and / or to control speed settings or other functions of centrifuge 400. In at least one exemplary embodiment, controller 1104 may be configured to communicate with cuff controller 1120, which may change or set the pressure of the pressure cuff on donor arm 102 during single-collection processes. In at least one exemplary embodiment, controller 1104 may be configured to communicate with strobe light 1114, which may be any light that flashes periodically in sync with the rotational speed of a motor, so that an operator of single-sampling system 200 can see the operation of filler 460. Controller 1104 may be configured to communicate with strobe light 1114 to change the flashing frequency and / or intensity of strobe light 1114.

[0068] Figure 8 It shows how to initialize, for example, in Figure 1-7 The flowchart illustrates an exemplary data input processing 1200 for the apheresis system 200 shown. Based on the acquired donor information, data input processing 1200 helps ensure a target amount or volume of plasma (or other blood components). Simultaneously, in at least one exemplary embodiment, data input processing 1200 may also allow input for other information, such as bottle identification information and / or collection device information, enabling the apheresis system 200 to record indications about which bottle and / or collection device was used for which donor 102. Figure 8 Data input processing 1200 of A can begin at 1202, in which the single-sampling system 200 is powered on to wait for a new donor 102.

[0069] In at least one exemplary embodiment, such as Figure 9As shown, the apheresis system 200 may include an integrated identifier reader (e.g., a radio-frequency identification (RFID) reader, barcode reader, etc.) 1221, configured to read codes (e.g., RFID tags, barcodes, etc.) associated with a specific donor 102, and to control and / or determine certain operational parameters of the apheresis system 200 based on information received through the identifier reader. This information and / or data may include biometric information, including, for example, age, weight, height, hematocrit, hemoglobin, donor history, and / or other information that may be relevant to the donation process. See again. Figure 8 Data input processing 1200 may include receiving donor-specific information 1203. For example, the single-donor system 200 may be configured to scan barcodes, quick-release codes, or other types of images to receive donor-specific information. For example, in at least one exemplary embodiment, the donor 102 may use an identification card or other type of object, which may include one or more of barcodes, quick-release codes, and / or RFID tags. The identification card or other type of object may be portable between donation sites, single-donor systems, and / or locations. Donor-specific information may be stored in or on the identification card or other type of object in the form of a nomogram (e.g., in a two-dimensional barcode). In this way, the donor 102 may carry a single form of identification between donation sites, and each donation site may be able to collect information about the donor 102, such as the time since the last visit.

[0070] By scanning identification cards or other types of objects, the apheresis system 200 can receive or is able to receive information and / or data related to a single donor 102, for example, without requiring further user input via a user interface. The apheresis system 200 can receive information, automatically verify data input, and evaluate information without human input. The received information can be used for a faster, safer, and higher-quality donor experience. For example, information received from donor 102 can be used to determine whether donor 102 is eligible for a donation procedure and to determine specific settings that the donation procedure may require, such as the total expected amount of plasma or other information.

[0071] In at least one exemplary embodiment, the identification card or other type of object may include information about the donor 102's weight and / or height and / or hematocrit and / or hemoglobin, which may be used alone or in combination to define the amount or volume of plasma (or other blood components) that the donor 102 can provide or donate. For example, as will be understood, in some examples, a donor 102 with a first weight may be permitted to donate a first amount of plasma, while in some examples, a donor 102 with a second, heavier weight may be permitted to donate a second amount of plasma greater than the first amount. Additionally or alternatively, the donor 102's weight may be used to define the amount or volume of plasma (or other blood components) that the donor 102 can provide or donate. Once the apheresis system 200 receives the information, it can, based on that information, use a graphical user interface (GUI) to adjust various settings and / or prompt one or more steps for nurses, practitioners, or other users or operators of the apheresis system 200, including initiating and stopping operations in response to determining or predicting a pre-determined donation capacity or event.

[0072] In at least one exemplary embodiment, the information stored or carried in an identification card or other type of object (e.g., in the form of a nomogram) may be limited to information that the individual collection system 200 is permitted to collect (e.g., through 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 individual collection system 200 may be encrypted or locked so that the individual collection system 200 (and more specifically, the integrated identification reader 1221) cannot read and / or obtain the recorded information and / or data.

[0073] In at least one exemplary embodiment, the apheresis system 200 (e.g., via control system 900 and / or computer system 1627) can transmit information and / or data 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 donation sites. For example, the apheresis system 200 can be configured to send information and / or data, such as donation results and / or the current weight of donor 102, and / or the date and / or time of previous donation, 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... Figure 10As shown, the single-sampling system 200 may include one or more computer systems 1627. The computer system 1627 may include, for example, a processor 1630, a memory 1633, input / output devices 1636, one or more pump control systems 1639, one or more sensors 1642, and / or other suitable components. The processor 1630 may be configured to execute software. This software may include firmware, applications, and / or an operating system capable of managing the execution of the single-sampling system 200. Figure 11 As shown, computer system 1627 can be configured to detect the start 1202 of single-collection system 200 and / or can be configured to transmit certain information and / or data to server 1621 via a connection to network 1618. In this way, single-collection system 200 can use a local system, such as a computer located at the donation site, to transmit certain information and / or data (e.g., data logs, firmware version identifiers, and error logs), which can also be configured to communicate with server 1621.

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

[0075] Refer again Figure 8 Method 1200 may also include using the received information and / or data to identify donor 102 1206. For example, in at least one exemplary embodiment, single-collection system 200 (e.g., using control system 900 and / or computer system 1627) may be configured to use information and / or data received via scanner 1221 to identify whether donor 102 1206 is associated with any existing donor 102 identity in the database and / or whether donor 102 is a new donor.

[0076] Method 1200 may further include receiving 1209 information and / or data associated with a blood component collection device to be used during the donation process. In at least one exemplary embodiment, the blood component collection device may include a soft-cassette assembly, such as soft-cassette assembly 300. In at least one exemplary embodiment, the information and / or data associated with the blood component collection device may be received 1209 by the apheresis system 200 via a barcode, quick-release code, RFID chip, and / or other types of scannable objects that may be associated with the blood component collection device. In at least one exemplary embodiment, each blood component collection device may be affixed with a label or sticker that includes different barcodes, quick-release codes, RFID chips, and / or other types of scannable objects. By scanning the label or sticker on the blood component collection device, the apheresis system 200 enables the recording in memory (and, in at least one embodiment, shared with server 1621) of which blood component collection device is being used in the current donation process. In this way, the apheresis system 200 enables the association of a donor with a selected blood component collection device. Data associated with a blood component collection device may include, for example, the manufacturing date and / or the manufacturer's identity and / or various other information that may be used for data processing purposes after donation. In at least one exemplary embodiment, data associated with the blood component collection group received by scanning receiver 1209 may be used to determine the type of blood component collection device. The type of blood component collection device may be used by apheresis system 200 to adjust one or more settings, such as flow rate or other information, during the donation process.

[0077] In at least one exemplary embodiment, after scanning the blood component collection device, the operator of the apheresis system 200 can receive confirmation of receipt of information from the blood component collection device. For example, as... Figure 12 As shown, the graphical user interface 1230 can display an indication of whether data has been received from the blood component collection device. In at least one exemplary embodiment, instead of displaying via the graphical user interface 1230, the apheresis system 200 can indicate that data has been received by playing audible sounds through one or more speakers or by displaying various colors of light.

[0078] Refer again Figure 8In at least one exemplary embodiment, method 1200 includes receiving 1212 data associated with a collection bottle. For example, in at least one exemplary embodiment, a collection bottle may be needed to initialize the blood collection system 200 for a new donor. After donation, the collection bottle may be filled with donated plasma (or other fluid). For data tracking purposes, the collection bottle may need to be associated with the donor, making it necessary to record the identity of the plasma collection bottle. Thus, it may be possible for the operator of the apheresis system 200 to use the apheresis system 200 to scan a label, sticker, or other object associated with the collection bottle (e.g., printed or affixed to the collection bottle). As with the steps detailed above, when receiving 1212 information and / or data from the plasma collection bottle, the apheresis system 200 may confirm the receipt of the data via a graphical user interface 1230 and / or a speaker and / or a white and / or other feedback system.

[0079] Method 1200 uses received data and / or information (including donor-specific information and / or data, and / or blood component collection device information and / or collection bottle information and / or data) to determine and / or select one or more operating parameters for the plasma donation process 1213. For example, in at least one exemplary embodiment, the apheresis system 200 may be configured (e.g., via control system 900 and / or computer system 1627) to use received information and / or data to calculate the amount or volume of plasma (or other components) that donor 102 can provide or donate. For example, exemplary method 600 for determining the amount or volume of plasma that donor 102 can provide or donate... Figure 13 As shown in the image.

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

[0081] In at least one exemplary implementation, the total blood volume can be determined using the LEMENS algorithm replicated below:

[0082] The ideal value is greater than or equal to about 65 and less than or equal to about 70, and in some respects, optionally about 70. The weight is the measured weight of the donor in kilograms (kg), and the body mass index (BMI) can be determined as follows:

[0083] Among them, height refers to the measured height of the donor, and the unit is meters (m).

[0084] In other exemplary embodiments, the total blood volume can be determined using a copy of the NADLER algorithm as follows:

[0085]

[0086] TBV m It is an algorithm for people who were designated as male at birth and TBV. f It is an algorithm used for people who were designated as female at birth.

[0087] 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 (BMI) can be transmitted to apheresis system 200 (and more specifically, control system 900 and / or computer system 1627) via donor identification cards or other types of objects as discussed above, and / or input from an operator, such as via graphical user interface 1230. Apheresis system 200 (and more specifically, control system 900 and / or computer system 1627) can be configured to determine BMI and / or receive a predetermined BMI, for example, from donor identification cards or other types of objects, and / or from input from nurses, practitioners, or other users or operators of apheresis system 200, such as via graphical user interface 1230. Apheresis system 200 (and more specifically, control system 900 and / or computer system 1627) can be configured to determine total blood volume (TBV) using, for example, the LEMMENS algorithm and / or NADLER algorithm. i ), and / or configured to receive a predetermined total blood volume, for example, from a donor identification card or other type of object, and / or from input made by a nurse, practitioner or other user or operator of the apheresis system 200, such as via a graphical user interface 1230.

[0088] Refer again Figure 13 Method 600 may include determining a donor-specific component amount 620. Determining the donor-specific component amount 620 may include using one or more of the relationships mentioned below.

[0089] As shown below, total blood volume (TBV) i ) equals the final total blood volume (TBV) f The total blood volume of the donor after donation (the total blood volume of the donor) and the donated platelet count (the volume of pure platelets in the plasma) and the donated plasma volume (the volume of pure plasma) and the donated red blood cell count (the volume of donated blood cells at 100% hematocrit) divided by the hematocrit of the donated red blood cells (hct) dr The sum of (which is usually about 80%).

[0090]

[0091] As shown below, total blood volume (TBV) i ) and the donor's initial hematocrit (hct) i The product of ) equals the final total blood volume (TBV). f ) and the donor's final hematocrit (hct) f The product of ( ) and the sum of the number of donated red blood cells,

[0092] The relationships (V) and (VI) introduced can be combined to solve for various component quantities. In at least one exemplary embodiment, the amount or volume of pure plasma to be collected can be determined at 620. For example, the amount or volume of donor-specific pure plasma (i.e., platelets and red blood cells = 0) to be collected (“donated plasma”) can be determined using the determined or received total blood volume (TBV) according to the following relationship. i ) and / or initial hematocrit (hct) i To determine the target changes in hematocrit and / or blood cell count:

[0093]

[0094]

[0095]

[0096]

[0097] For example, by way of illustration only, the donor has a total blood volume of 4000 mL and a hematocrit of 0.45. i Furthermore, with a target change in hematocrit of 8%, the amount of donated plasma to be collected can be determined as follows:

[0098] Hematocrit (hct) iThe hematocrit (i.e., the volume fraction of red blood cells in the blood expressed in decimal form) of donor 102 is a measurement of hematocrit and can be transmitted to apheresis system 200 (and more specifically, control system 900 and / or computer system 1627) via donor identification cards or other types of objects as described above, and / or from nurses, practitioners, or other users or operators of apheresis system 200, for example, via input through a graphical user interface. Apheresis system 200 (and more specifically, control system 900 and / or computer system 1627) can be configured to perform plasma donation 1215 and / or determine 620 the specific amount or volume of pure plasma to be collected from the donor only when the hematocrit is found to be within a predetermined threshold, for example, between greater than or equal to about 0.38 and less than or equal to about 0.54.

[0099] Hematocrit levels increase as plasma is removed from the donor. A target change in hematocrit reflects this difference and is chosen as a desired constant. The target change in hematocrit is fixed, and the apheresis system 200 (and more specifically, the control system 900 and / or computer system 1627) can receive and / or generate and / or locally store a donor-common value. In at least one exemplary embodiment, the target change in hematocrit can be transmitted to the apheresis system 200 (and more specifically, the control system 900 and / or computer system 1627) via a server 1621.

[0100] Select a target variation in hematocrit such that the donor's post-hematocrit is, for example, an acceptable and safe post-hematocrit as determined by different regulatory agencies. In at least one exemplary embodiment, the target change in hematocrit may be greater than or equal to about 1% (e.g., greater than or equal to about 1.5%, greater than or equal to about 2%, greater than or equal to about 2.5%, greater than or equal to about 3%, greater than or equal to about 3.5%, greater than or equal to about 4%, greater than or equal to about 4.5%, greater than or equal to about 5%, greater than or equal to about 5.5%, greater than or equal to about 6%, greater than or equal to about 6.5%, greater than or equal to about 7%, greater than or equal to about 7.5%, greater than or equal to about 8%, greater than or equal to about 8.5%, greater than or equal to about 9%, greater than or equal to about 9.5%, greater than or equal to about 10%, greater than or equal to about 10.5%, greater than or equal to about 11%, greater than or equal to about 11.5%, greater than or equal to about 12%, greater than or equal to about 12.5%, greater than or equal to about 13%, greater than or equal to about 13.5%, greater than or equal to about 14%, greater than or equal to about 14.5%). In at least one exemplary embodiment, the target change in hematocrit may be less than or equal to about 15% (e.g., less than or equal to about 14.5%, less than or equal to about 14%, less than or equal to about 13.5%, less than or equal to about 13%, less than or equal to about 12.5%, less than or equal to about 12%, less than or equal to about 11.5%, less than or equal to about 11%, less than or equal to about 10.5%, less than or equal to about 10%, less than or equal to about 9.5%, less than or equal to about 9%, less than or equal to about 8.5%, less than or equal to about 8%, less than or equal to about 7.5%, less than or equal to about 7%, less than or equal to about 6.5%, less than or equal to about 6%, less than or equal to about 5.5%, less than or equal to about 5%, less than or equal to about 4.5%, less than or equal to about 4%, less than or equal to about 3.5%, less than or equal to about 3%, less than or equal to about 2.5%, less than or equal to about 2%, less than or equal to about 1.5%). In at least one exemplary embodiment, the target change in hematocrit can range from 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 can be about 8%.

[0101] In at least one exemplary embodiment, the amount or volume of pure red blood cells to be collected (i.e., platelets and plasma = 0) (“donated red blood cells”) can be determined at 620. For example, the donor-specific amount or volume of red blood cells to be collected can be determined using the determined or received total blood volume (TBV) according to the following relationship. i ) and / or initial hematocrit (hct) i To determine:

[0102]

[0103]

[0104]

[0105]

[0106]

[0107]

[0108] Refer again Figure 8 Method 1200 may terminate at 1218, where the donation process may continue to complete the extraction of fluid from the donor. Any information and / or data received through the above steps may be recorded in memory and / or shared with one or more computer systems 1627. For example, database entries may be created for a particular donation, including information such as the amount or volume of plasma extracted from the donor, the donor's current weight, the time and / or date of donation, and / or other information and / or data.

[0109] The foregoing description of embodiments has been provided for purposes of illustration and description. The foregoing is intended to be exhaustive or limiting of this disclosure. Elements or features of a particular embodiment are generally not limited to that particular embodiment, and are interchangeable where applicable, and may be used in selected embodiments even without specific illustration or description. Variations are also possible in various ways. Such variations should not be considered a departure from this disclosure, and all such modifications are intended to be included within the scope of this disclosure.

Claims

1. A method for collecting blood components using a medical system, the method comprising: The medical system receives data associated with individual subjects, including the subject's initial hematocrit. The medical system identifies specific pure component quantities of the subject to be collected by the medical system, and determines these specific pure component quantities using the subject's initial hematocrit, the subject's initial total blood volume, and the target change in hematocrit. as well as Using the medical system, a component donation process is performed to collect specific amounts of pure components from the identified subject to be collected.

2. The method according to claim 1, wherein, Receiving data associated with individual subjects includes scanning images using a scanner.

3. The method according to claim 2, wherein, The scanner is mounted on the medical system.

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

5. The method according to claim 1, further comprising: The medical system uses received data associated with individual subjects to identify the subjects. And through the medical system, adjust one or more parameters of the component donation process.

6. The method according to claim 1, further comprising: The medical system receives data associated with the blood component collection device. And through the medical system, adjust one or more parameters of the component donation process.

7. The method according to claim 1, further comprising: The medical system receives data associated with the component collection bottle. as well as The medical system adjusts one or more parameters of the component donation process.

8. The method according to claim 1, wherein, The data associated with individual subjects also includes total blood volume.

9. The method according to claim 1, further comprising: The total blood volume of a subject is determined using the received data associated with an individual subject through the medical system.

10. The method of claim 9, further comprising: The medical system uses received data associated with an individual subject to determine the subject's body mass index.

11. The method according to claim 1, wherein, The target change in hematocrit is a preselected constant ranging from about 1% to about 15%.

12. The method according to claim 1, wherein, The target change in hematocrit is selected based on the subject's initial hematocrit and acceptable post-hematocrit levels.

13. The method according to claim 12, wherein, The difference between the subject’s initial hematocrit and the acceptable post-hematocrit level ranged from about 1% to about 15%.

14. The method according to claim 11, wherein, The target change in hematocrit is approximately 8%.

15. The method according to claim 1, wherein, The subject-specific pure component amount includes only plasma, and the subject-specific pure component amount to be collected by the medical system can be determined by the medical system according to the following relationship: ； Among them, TBV i It is the initial total blood volume of the subject, and hct i It is the initial hematocrit of the subject.

16. The method according to claim 1, further comprising: After receiving the data associated with the individual subject, a feedback system is used to confirm the receipt of the data associated with the individual subject.

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

Images