Apparatus, system, and method for plasma rinse-back

Abstract

A system for minimizing residual blood values ​​via plasma rinse-back comprises a collection bag, a return reservoir container, one or more pumps, and one or more lines. The collection bag is configured to store plasma collected from the donor during the blood collection process. The return reservoir container is configured to collect any fluid remaining in the system after the blood collection process is complete. One or more pumps are configured to operate between an operating and non-operating state during the blood collection process and plasma rinse-back. One or more lines are configured to connect the collection bag, the return reservoir container, one or more pumps, and the donor. The system is configured to perform plasma rinse-back after the blood collection process is complete, returning the fluid in the system to the donor.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims priority to U.S. Patent Application No. 18 / 212,806, filed on June 22, 2023. The entire disclosure of the above application is incorporated herein by reference.

[0002] This disclosure relates to a plasma rinse - back procedure implemented in an apheresis system.

Background Art

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

[0004] An apheresis system has a rinse - back procedure that returns residual fluid remaining in the disposable kit of the system to the donor. Typically, not all of the fluid remaining in the disposable kit is returned to the donor, so there is a residual level remaining in the disposable kit after the return process is completed.

Summary of the Invention

Problems to be Solved by the Invention

[0005] Therefore, it is desired to develop an assembly for reducing the residual level remaining in an apheresis system and a method for reducing the residual level remaining in an apheresis system.

Means for Solving the Problems

[0006] This section provides a general overview of this disclosure and is not an exhaustive disclosure of the full scope or all features.

[0007] This disclosure provides a system for minimizing residual blood values ​​via a plasma rinse-back, comprising a collection bag, a return reservoir container, one or more pumps, and one or more lines. The collection bag is configured to store plasma collected from a donor during a blood collection process. The return reservoir container is configured to collect any fluid remaining in the system after the blood collection process is completed. The one or more pumps are configured to operate between an operating and non-operating state during the blood collection process and the plasma rinse-back. The one or more lines are configured to connect the collection bag, the return reservoir container, the one or more pumps, and the donor. The system is configured to perform the plasma rinse-back, returning the fluid in the system to the donor after the blood collection process is completed.

[0008] In one or more exemplary embodiments, the plasma rinse bag has a plasma outflow process, the plasma outflow process includes opening a valve on the collection bag, allowing the stored plasma to flow out of the collection bag for a predetermined time, and closing the valve after the predetermined time. The stored plasma flowing out of the collection bag is configured to flow out into the return reservoir container by gravity. In one or more exemplary embodiments, the system is further configured to perform a plasma flush after the plasma rinse bag. The plasma flush includes operating a first pump of the one or more pumps to allow the plasma to flow out of the return reservoir container until a lower sensor on the return reservoir container detects air. The plasma is configured to flow out of the return reservoir container through the one or more lines to flush out any collected fluid remaining in the system after the blood collection process is complete and return it to the donor. In one or more exemplary embodiments, the residual blood value is the amount of collected fluid remaining in the system after the plasma flush is complete. The plasma flush is configured to reduce the amount of the collected fluid remaining in the system after the plasma flush to below a threshold. In one or more exemplary embodiments, the system further includes an alarm configured to activate if the valve is open for longer than a predetermined time.

[0009] In one or more exemplary embodiments, the collection bag is configured to be positioned above the donor by a threshold distance.

[0010] In one or more exemplary embodiments, the system further monitors the return reservoir container after the blood collection process is complete, and if the fluid in the return reservoir container exceeds a threshold amount, it operates a first pump of the one or more pumps to drain the fluid from the return reservoir container. In one or more exemplary embodiments, the system further operates the first pump to return the fluid drained from the return reservoir container to the donor. Operating the first pump to return the fluid drained from the return reservoir container to the donor includes pumping the fluid out of the system's channels. In one or more exemplary embodiments, the system further comprises an anticoagulant source. The system is further configured to operate a second pump and a third pump to flow the anticoagulant from the anticoagulant source into the one or more lines and into the channels after the first pump has pumped the fluid out of the channels. In one or more exemplary embodiments, the plasma rinse-back is performed after the second and third pumps have delivered the anticoagulant through the one or more lines into the channels.

[0011] The Disclosure further provides a method for minimizing residual blood values ​​via a plasma rinse-back. The method comprises the step of performing a blood collection process via an apheresis system. The apheresis system comprises a collection bag, a return reservoir container, one or more pumps, and one or more lines. The collection bag is configured to store plasma collected from a donor during the blood collection process. The return reservoir container is configured to collect any fluid remaining in the apheresis system after the blood collection process is completed. The one or more pumps are configured to operate between an operating state and a non-operating state during the blood collection process and the plasma rinse-back. The one or more lines are configured to connect the collection bag, the return reservoir container, the one or more pumps, and the donor. The method further comprises the step of performing the plasma rinse-back, which returns the fluid in the apheresis system to the donor after the blood collection process is completed.

[0012] In one or more exemplary embodiments, the step of performing the plasma rinse-back includes opening a valve on the collection bag, draining the stored plasma from the collection bag for a predetermined time, and closing the valve after the predetermined time. The stored plasma drained from the collection bag is drained by gravity into the return reservoir container. In one or more exemplary embodiments, the method further includes performing a plasma flush after performing the plasma rinse-back. The plasma flush includes operating a first pump of the one or more pumps to drain the plasma from the return reservoir container until a lower sensor on the return reservoir container detects air. The plasma flows from the return reservoir container through the one or more lines, flushing the collected fluid remaining in the apheresis system after the blood collection process is complete and returning it to the donor. In one or more exemplary embodiments, the residual blood value is the amount of collected fluid remaining in the apheresis system after the plasma flush is complete. The plasma flush reduces the amount of the collected fluid remaining in the apheresis system after the plasma flush to below a threshold. In one or more exemplary embodiments, the method further includes the step of activating an alarm if the valve is open for longer than a predetermined time.

[0013] In one or more exemplary embodiments, the collection bag is configured to be positioned above the donor by a threshold distance.

[0014] In one or more exemplary embodiments, the method further comprises the steps of monitoring the return reservoir container after the blood collection process is completed, and, if the return reservoir container contains a fluid exceeding a threshold amount, operating a first pump of the one or more pumps to drain the fluid from the return reservoir container. In one or more exemplary embodiments, the method further comprises the step of operating the first pump to return the fluid drained from the return reservoir container to the donor. The step of operating the first pump to return the fluid drained from the return reservoir container to the donor includes the step of pumping the fluid out of the channels of the apheresis system. In one or more exemplary embodiments, the method further comprises the step of operating a second pump and a third pump after the first pump has pumped the fluid out of the channels to allow an anticoagulant from an anticoagulant source to flow into the one or more lines and into the channels. In one or more exemplary embodiments, the step of performing the plasma rinse-back is performed after the second and third pumps have delivered the anticoagulant through the one or more lines and into the channels.

[0015] 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.

[0016] 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]

[0017] [Figure 1] Figure 1 is a schematic diagram of an apheresis system according to an exemplary embodiment of the present disclosure. [Figure 2] Figure 2 is a flowchart of a plasma rinse-back method according to an exemplary embodiment of the present disclosure. [Figure 3] FIG. 3 is a flowchart of a discharge method of the plasma rinse-back method of FIG. 2 according to an exemplary embodiment of the present disclosure. [Figure 4] FIG. 4 is a flowchart of an inlet line flushing process of the plasma rinse-back method of FIG. 2 according to an exemplary embodiment of the present disclosure. [Figure 5] FIG. 5 is a flowchart of a plasma outflow process of the plasma rinse-back method of FIG. 2 according to an exemplary embodiment of the present disclosure. [Figure 6] FIG. 6 is a front view of a part of the apheresis system of FIG. 1 showing the height of the plasma bag according to an exemplary embodiment of the present disclosure. [Figure 7] FIG. 7 is a block diagram of a computer system of the apheresis system of FIG. 1 according to an exemplary embodiment of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

[0018] Corresponding reference numerals indicate corresponding parts in the above figures.

[0019] The exemplary embodiments will be described in more detail with reference to the accompanying drawings.

[0020] The exemplary embodiments are provided to enable those skilled in the art to fully understand the present disclosure and to convey the full scope thereof. To provide a complete understanding of the embodiments of the present disclosure, numerous specific details such as examples of specific components, devices, and methods are described. It will be apparent to those skilled in the art that specific details are not necessary, that the exemplary embodiments can be embodied in many different forms, and that none of them should be construed as limiting the scope of the present disclosure. In some exemplary embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.

[0021] The terms used in this specification are for the purpose of describing particular exemplary embodiments only and are not intended to be limiting. As used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises", "comprising", "including", and "having" are inclusive and thus specify the presence of stated features, entities, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or their groups. Steps, processes, and operations of methods described herein are not to be construed as necessarily requiring execution in the particular order described or illustrated, unless specifically specified as the order of execution. It is also to be understood that additional or alternative steps may be used.

[0022] When an element or layer is referred to as being "on", "engaged to", "connected to", or "coupled to" another element or another layer, it may be directly on, engaged directly to, connected directly to, or coupled directly to the other element or the other layer, or intervening elements or intervening layers may be present. On the other hand, when an element is referred to as being "directly on", "directly engaged to", "directly connected to", or "directly coupled to" another element or another layer, no intervening elements or intervening layers are present. Other words used to describe the relationship between elements are to be interpreted in a like manner (e.g., "between" versus "directly between", "adjacent" versus "directly adjacent", etc.). As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0023] 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.

[0024] 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.

[0025] 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 function described; or any combination of some or all of the above, such as a system on a chip.

[0026] 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.

[0027] 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.

[0028] The terms "memory circuit" and "memory" are included in the term "computer-readable medium." 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).

[0029] 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.

[0030] 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.

[0031] 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®.

[0032] Exemplary embodiments will be described in more detail with reference to the accompanying drawings.

[0033] Figure 1 shows an apheresis system 100 according to an exemplary embodiment of the present disclosure. The apheresis system 100 is configured to connect to a donor to collect and / or separate blood components, including one or more of plasma and / or red blood cells, during a blood collection process. The apheresis system 100 includes a needle 102 configured to be inserted into the donor (for example, into the donor's vein via venipuncture). Once the donor is connected to the apheresis system 100, an intravenous pathway is formed for blood to flow from the donor to the apheresis system 100. The needle 102 is connected to a donor line 104, which forms a pathway for fluid to flow from the donor to the apheresis system 100.

[0034] In one or more exemplary embodiments, the apheresis system 100 includes a sample line 106 configured to connect a donor line 104 to a sample collection bag 108. In one or more exemplary embodiments, the sample line 106 and the donor line 104 are connected by a connector 110, which may be a Y-connector or other connector, and is configured to stop or allow the flow of fluid to the sample line 106 and the sample collection bag 108.

[0035] The donor line 104 is connected to the manifold 112. The manifold 112 is configured to establish a connection between the donor line 104 and one or more lines of the apheresis system 100. These one or more lines include a first line 114 which is an anticoagulant (AC) line, a second line 116 which is a return line, a third line 118 which is a draw-in or inlet line, and so on. The first line 114 is configured to engage with a first pump 120 which is an AC pump. The first line 114 is also configured to extend to a connector 122. The connector 122 is configured to connect the first line 114 to an AC source 115. The AC source 115 is connected to the apheresis system 100 and supplies AC to the apheresis system 100. The AC can prevent blood from clotting in the apheresis system 100.

[0036] The anticoagulant may include, but is not limited to, one or more citrates and / or unfractionated heparin. The AC source 115 may be a bag or a bottle, and the bags or bottles described herein may be formed from, but are not limited to, one or more of the following: polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene with vinyl acetate (EVA), rubber, silicone, thermoplastics, thermoplastic elastomers, polymers, copolymers, and / or combinations thereof. The amount of AC in the AC source 115 may vary based on various factors such as the donor's body weight and the volumetric flow rate of blood from the donor. In one example, the volume in the AC source 115 is 250-500 mL, but the volume in the AC source 115 may be greater or less than the above volume.

[0037] A second line 116 is configured to engage with a second pump 124, which is a return pump. The second line 116 is also configured to connect to a return reservoir container 126. The return reservoir container 126 is configured to collect fluid to be returned to the donor from the apheresis system 100 after the blood collection process is complete. The return reservoir container 126 has a sensor at its first end. The sensor is configured to detect air, which can indicate the volume of fluid in the return reservoir container 126. For example, in some exemplary embodiments, the fluid may be discharged from the return reservoir container 126 until the sensor detects air, indicating that the volume remaining in the return reservoir container 126 is a threshold volume.

[0038] The third line 118 is configured to deliver fluid from the donor line 104 into the apheresis system 100. The third line 118 is configured to engage with a third pump 127, such as an inlet or outlet pump, to deliver fluid from the donor into a centrifuge (not shown) configured to separate components of the blood from the donor.

[0039] The separated components are sent to one or more collection chambers 128 of the apheresis system 100. The one or more collection chambers 128 are connected to the channel 129. One or more lines are provided, such as an erythrocyte line 130 and a plasma line 132, configured to transport erythrocytes and plasma to one or more corresponding collection chambers 128 and a plasma bag 134 during the blood collection process. In one or more exemplary embodiments, the plasma bag 134 is referred to as the collection bag. The plasma bag 134 is configured to collect plasma obtained from the donor during the blood collection process via a fourth pump 133 or plasma pump. The plasma line 132 has a first portion 132A located between the fourth pump 133 and the third pump 127, and a second portion 132B located between the plasma bag 134 and the fourth pump 133. In one or more exemplary embodiments, after the blood collection process is complete, the plasma valve 135 is opened during plasma rinse-back to release the plasma from the plasma bag 134 and return the fluid in the apheresis system 100 to the donor. The plasma rinse-back process is described in more detail below.

[0040] In at least one exemplary embodiment, the first pump 120, the second pump 124, the third pump 127, and / or the fourth pump 133 are tube pumps, peristaltic pumps, diaphragm pumps, and / or other pumps configured to control the flow of fluid (e.g., blood, blood components, anticoagulants, saline solution, etc.) within at least a portion of the tube. For example, the first pump 120, the second pump 124, and / or the third pump 127 may include motors operably interconnected with a rotating tube contact assembly.

[0041] In one or more exemplary embodiments, the apheresis system 100 includes a vent bag 136 and an air removal bag 138. The vent bag 136 is configured to supply fluid for venting the apheresis system 100. The air removal bag 138 is configured to collect air from the plasma bag 134 via an air removal line 140 connected between the plasma bag 134 and the air removal bag 138.

[0042] In one or more exemplary embodiments, the apheresis system 100 also includes an erythrocyte valve 142. The erythrocyte valve 142 is configured to open and close in response to various operations of the apheresis system 100.

[0043] In one or more exemplary embodiments, the apheresis system 100 also includes an access pressure sensor (APS) 144. The APS 144 is configured to detect blockages in the third line 118.

[0044] Figure 1 shows how the disposable elements of the apheresis system 100 are connected to the non-disposable elements, which are enclosed by solid or dashed lines. For example, the first pump 120, the second pump 124, the third pump 127, and the fourth pump 133 are enclosed by dashed lines, indicating which lines of the apheresis system 100 each pump interacts with.

[0045] The operation of various pumps, valves, and blood component separators or centrifuges may be controlled by one or more processors included in the apheresis system 100, 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. In at least one exemplary embodiment, to assist the operator of the apheresis system 100 in various aspects of its operation, the blood component separator or centrifuge may include a graphical user interface (GUI) with a display including an interactive touchscreen.

[0046] Figure 2 shows a flowchart of method 200 for performing plasma rinseback. Plasma rinseback is a procedure, process, or method for draining fluid from an apheresis system 100 to reduce the amount of residual blood remaining in the apheresis system 100 after the blood collection process is complete.

[0047] In one or more exemplary embodiments, the GUI of the apheresis system 100 is configured to output a visual display of the amount of plasma collected from the donor during the plasma rinse-back process. The GUI may also be configured to output a summary status of the plasma rinse-back process after method 200 is completed. The output summary status may include a display of the amount of plasma collected by the apheresis system 100 during the blood collection process.

[0048] Method 200 begins when the blood collection process is complete, the first pump 120, the second pump 124, the third pump 127, and the fourth pump 133 are stopped, and each valve in the apheresis system 100 is set to the return state. In step 202, the processor of the apheresis system 100 operates the second pump 124 to drain fluid from the return reservoir container 126 to return it to the donor. The second pump 124 is set to a rate such that it drains fluid from the return reservoir container 126 at a flow rate between the maximum allowable return flow rate and the maximum needle flow rate that are permissible in any step of the plasma rinse-back process. In some embodiments, the maximum needle flow rate is about 100 mL / min.

[0049] In condition step 204, the controller of the apheresis system 100 determines whether the volume of fluid in the return reservoir container 126 is greater than or equal to a threshold. In at least one exemplary embodiment, the threshold is a fluid volume of about 10 mL. In other embodiments, the threshold may be a different volume. In at least one exemplary embodiment, a sensor in the return reservoir container 126 is configured to detect whether the volume in the return reservoir container 126 is greater than or equal to a threshold. For example, if the sensor does not detect air, the volume of fluid in the return reservoir container 126 is greater than or equal to the threshold. If the volume is greater than or equal to the threshold, method 200 returns to step 202, and the second pump 124 continues to operate. If the volume is less than the threshold, method 200 proceeds to step 206.

[0050] In step 206, the processor of the apheresis system 100 initiates the inlet line flushing process. The inlet line flushing process is configured to flush any remaining blood in the third line 118 of the apheresis system 100 into channel 129 using AC. The blood flowing into channel 129 is removed by the fourth pump 133 via the plasma line 132. This blood is collected in a return reservoir container 126, as will be described in more detail herein. The first pump 120, the third pump 127, and the fourth pump 133 are operated to carry out the inlet line flushing process. The first pump 120 and the third pump 127 can flow AC into the apheresis system 100 to return any remaining fluid in the apheresis system 100 towards the donor. The fourth pump 133 is also operating during the inlet line flushing process to drain fluid from channel 129. The inlet line flushing process is completed when a predetermined volume of fluid is processed by the third line 118. The volume of fluid processed by the third line 118 is determined by the rotational speed of one or both of the first pump 120 and the third pump 127. In some embodiments, the predetermined volume of fluid is about 14 mL. In other embodiments, the predetermined volume may be less than or greater than 14 mL.

[0051] In step 208, the processor of the apheresis system 100 initiates the channel draining process. The channel draining process returns the fluid in the return reservoir container 126 to the donor while continuing to drain channel 129. The channel draining process is described in detail below with reference to Figure 3.

[0052] In step 210, the processor of the apheresis system 100 initiates the plasma outflow process after the channel draining process is complete. The plasma outflow process begins when the processor opens the plasma valve 135. When the plasma valve 135 is opened, plasma from the plasma bag 134 flows out into the return reservoir container by gravity. The plasma valve 135 is kept open for a predetermined time to allow a predetermined amount of plasma to flow out of the plasma bag 134. In some embodiments, the predetermined amount of plasma may be about 30 mL of plasma, and the predetermined time may be about 9 seconds. In at least one exemplary embodiment, there may be an indeterminate time range for the predetermined amount of time until an alarm is triggered indicating that the valve 135 has remained open for an extended period. For example, 2 seconds may be added as a buffer to the predetermined 9 seconds until an alarm condition is triggered within the apheresis system 100.

[0053] After the plasma outflow process is complete, the processor performs a plasma flush process in step 212. During the plasma flush process, the processor operates a second pump 124 to move fluid from the return reservoir 126 through the apheresis system 100 towards the donor until a sensor in the return reservoir 126 detects air. When the sensor detects air, the fluid level in the return reservoir 126 falls below a threshold, and the plasma outflow process is complete. The second pump 124 is set to a rate such that it drains fluid from the return reservoir 126 at a flow rate between the maximum allowable return flow rate and the maximum needle flow rate that are permitted at any step of the plasma rinse-back process. In some embodiments, the maximum needle flow rate is approximately 100 mL / min.

[0054] If too much fluid is pumped back to the donor, an irreversible alarm condition may occur during the plasma outflow process. This alarm condition can prevent the outflowed plasma from reaching the donor during the plasma outflow process. In at least one exemplary embodiment, the volume returned to the donor is monitored after the plasma valve 135 is set to the open position. If the volume of fluid returned to the donor after the plasma valve 135 is opened exceeds a threshold, an alarm condition is triggered. The alarm may be a visual, audible, or other type of alarm that indicates that this irreversible alarm condition has occurred.

[0055] In one or more exemplary embodiments, the apheresis system 100 has additional alarm conditions that are monitored during the plasma outflow process. For example, the apheresis system 100 can monitor the air within the apheresis system 100 and prevent air from returning to the donor. Furthermore, the apheresis system 100 may have a power outage mode. In power outage mode, if the apheresis system 100 loses power during the plasma outflow process, it closes the plasma valve 135 when power is restored to the apheresis system 100. If power outage mode occurs during the plasma outflow process, the apheresis system 100 proceeds to disconnect from the donor when power is restored to the apheresis system. Thus, method 200 can be terminated early if there is a power outage during the plasma outflow process.

[0056] Method 200 is terminated when the plasma outflow process is complete. Once the plasma outflow process is complete, the donor is disconnected from the apheresis system 100, and the blood collection process and plasma rinse-back process are completed.

[0057] Figure 3 shows Method 300 of the channel discharge process in step 208 of Method 200. This method begins with step 302, which involves a first discharge process.

[0058] The first draining process includes the step of operating the second pump 124 at a first speed. In at least one exemplary embodiment, the first speed is the minimum adjustable speed, taking into account the possibility of adding a small amount of AC (e.g., dextrose citrate solution A (ACD-A solution)) to the whole blood to be mixed with the whole blood being returned. The fourth pump 133 is operated at a faster speed than the second pump 124. In at least one exemplary embodiment, the fourth pump 133 may be operated at the first speed. During the first draining process, the red blood cell valve 142 is closed.

[0059] After the first discharge process, method 300 proceeds to condition step 304, in which the processor determines whether the volume processed by the second pump 124 is greater than the first threshold volume. If the volume processed by the second pump 124 is less than the first threshold volume, method 300 proceeds to step 306, in which the second discharge process is performed. In one or more exemplary embodiments, the first threshold volume is the volume processed through the return reservoir container 126. The volume processed by the second pump 124 may exceed the first threshold volume when a sensor in the return reservoir container 126 detects air. If the sensor in the return reservoir container 126 detects air, this indicates that the channel 129 is empty and no fluid is being drawn from the channel 129 into the return reservoir container 126. If the sensor in the return reservoir container 126 does not detect air, the second discharge process is performed.

[0060] The second discharge process includes the step of operating the fourth pump 133 at the same speed as it was operated in the first discharge process. The second pump 124 is turned off during the second discharge process. The second discharge process is completed when a predetermined volume of fluid has been delivered by the fourth pump 133.

[0061] Following the second discharge process, method 300 proceeds to step 307, where a return discharge process is performed. The return discharge process includes operating the second pump 124 and the fourth pump 133 at the same speed as described above for the first discharge process.

[0062] After the return discharge process, method 300 proceeds to condition step 308, in which the processor determines whether the volume processed by the second pump 124 is less than a second threshold volume. If the volume processed by the second pump 124 is greater than or equal to the first threshold volume, method 300 returns to step 306, in which case the second discharge process is performed. As described above, the second discharge process includes the step of operating the fourth pump 133 at the same speed as it was operated in the first discharge process. The second pump 124 is turned off during the second discharge process. If the volume processed by the second pump 124 is less than the first threshold volume, method 300 proceeds to step 310.

[0063] In step 310, the processor determines whether the red blood cell volume is equal to zero. If the red blood cell volume is equal to zero, the red blood cell valve 142 is opened or set to the return position, and method 300 proceeds to step 314, where final channel efflux is performed. If the red blood cell volume is not equal to zero, method 300 proceeds to step 314.

[0064] The final channel discharge includes the step of operating the second pump 124 and the fourth pump 133 at the same speed as described above for the second discharge process.

[0065] After the final channel discharge is complete, method 300 proceeds to step 316, which performs the final return discharge. The final return discharge includes operating the second pump 124 and the fourth pump 133 at the same speed as described above for the first discharge process.

[0066] In one or more exemplary embodiments, if the apheresis system 100 is unable to empty channel 129, the apheresis system 100 generates an irreversible alarm condition. If the channel cannot be emptied, a blood volume reduction or air entering the donor may occur. The apheresis system 100 may also monitor the volume of fluid being processed by the second pump 124 and may indicate that the donor should be disconnected from the apheresis system 100 when a threshold volume of fluid is processed by the second pump 124. In one or more exemplary embodiments, if a blood volume reduction is detected, the apheresis system may output an alarm. The alarm may be visual, audible, or of other types that can indicate that this irreversible alarm condition has occurred.

[0067] Figure 4 shows method 400 for monitoring the inlet line flushing process in step 206. Method 400 is initiated after the volume in the return reservoir container is below a threshold volume and the inlet line flushing process has started. In step 402, the third line 118 is monitored. In condition step 404, the processor determines whether an obstruction has been detected in the third line 118. If no obstruction is detected, method 400 continues to monitor the third line 118. If an obstruction is detected, method 400 terminates by stopping the plasma rinse-back process. Thus, if an obstruction is detected in condition step 404, method 200 terminates in step 206. In one or more exemplary embodiments, if an obstruction is detected, the apheresis system outputs an alarm. The alarm may be visual, audible, or of other types that indicate that method 200 has terminated.

[0068] Method 400 describes an irreversible alarm condition of the apheresis system 100, which results in the shutdown of Method 200 to prevent an over-infusion of anticoagulant to the donor. In one or more exemplary embodiments, the apheresis system 100 has an APS sensor 144 configured to detect blockages in a third line 118 between the manifold 112 and the APS 144, and blockages between the APS 144 and the third pump 127.

[0069] In one or more exemplary embodiments, the apheresis system 100 is also configured to terminate Method 200 if an obstruction is detected in the first line 114. If an obstruction is detected in the first line 114, there may be less AC being pumped to the apheresis system 100 during the execution of Method 200, resulting in less fluid returning from the apheresis system 100 to the donor. This may lead to an undesirable increase in the residual fluid level in the apheresis system 100. Therefore, if an obstruction is detected in the first line 114, Method 200 is terminated.

[0070] In one or more exemplary embodiments, if the apheresis system 100 is pumping excess AC to the apheresis system 100, the apheresis system 100 is configured to terminate method 200. If excess AC is pumped to the apheresis system 100, there is a risk that the excess AC will reach the donor. Therefore, if excess AC is pumped to the apheresis system 100, method 200 is terminated.

[0071] Figure 5 shows method 500 for monitoring the plasma outflow process in step 210. Method 500 is initiated when the channel outflow process is complete and the plasma outflow process has started. In step 502, the second portion 132B of plasma line 132 is monitored. Condition step 504 determines whether an obstruction has been detected in the second portion 132B of plasma line 132. If no obstruction is detected, method 500 continues to monitor the second portion 132B of plasma line 132. If an obstruction is detected, method 500 proceeds to step 506 and continues to monitor the second portion 132B of plasma line 132. Condition step 508 determines whether an obstruction has been detected in the second portion 132B of plasma line 132. If no obstruction is detected, method 500 continues to monitor the second portion 132B of plasma line 132. If an obstruction is detected, method 500 terminates by stopping the plasma rinse-back process. Therefore, if an obstruction is detected in condition step 508, method 200 terminates in step 210. In one or more exemplary embodiments, if an obstruction is detected, the apheresis system outputs an alarm. The alarm may be visual, audible, or of other types that indicate that method 200 has terminated.

[0072] Method 500 describes an irreversible alarm condition of the apheresis system 100. This alarm condition results in the termination of Method 200 to prevent an over-infusion of anticoagulants to the donor. In one or more exemplary embodiments, if an occlusion is detected in condition step 504, a message is displayed on the graphical user interface of the apheresis system 100. The user may manually select a continue option that allows Method 500 to proceed to step 506. If a second occlusion is detected in condition step 508, the apheresis system 100 may terminate the process by ending the plasma rinse-back process without presenting the user with a continue option.

[0073] Figure 6 is a partial front view of the apheresis system 100, showing the height of the pole holding the plasma bag 134. Although not shown in Figure 6, the plasma bag 134 is mounted on a horizontal pole 602 connected to a vertical pole 604 having a height 606. The height 606 is configured based on the desired amount of plasma to be drained from the plasma bag 134 to flush out excess fluid from the apheresis system 100. In at least one exemplary embodiment, the height 606 is about 18.5 inches. In other embodiments, the height 606 may be greater than or less than 18.5 inches, depending on the amount of residue that is desired to be flushed out of the apheresis system 100 after the completion of the blood collection process.

[0074] Figure 7 shows an exemplary embodiment of a computer system 700 that may be included in the apheresis system 100. The computer system 700 includes a processor 702, memory 704, and one or more input / output devices 706. The processor 702 is the processor described above with reference to the methods shown in Figures 2 to 5. As can be understood, depending on the implementation of the computer system 700, the computer system 700 may include additional components other than those shown in Figure 7. For illustrative purposes, the exemplary embodiment shown in Figure 7 is described with respect to the processor 702. However, it should be understood that the computer system 700 may include one or more processors or other processing circuits, such as one or more application-specific integrated circuits (ASICs).

[0075] Memory 704 may be a computer-readable storage medium that generally includes random access memory (RAM), read-only memory (ROM), and / or permanent mass storage devices such as disk drives. Memory 704 also stores an operating system and any other routines / modules / applications for providing the functionality of network nodes (including UPF, CPF, MPF, etc.) to be executed by processor 702. These software components may be loaded into memory 704 from a separate computer-readable storage medium using a drive mechanism (not shown). Such a separate computer-readable storage medium may include a disk, tape, DVD / CD-ROM drive, memory card, or other similar computer-readable storage medium (not shown). In some exemplary embodiments, the software components may be loaded into memory 704 not via a computer-readable storage medium, but via one of one or more input / output devices 706.

[0076] The processor 702 or other processing circuit is configured to execute instructions of a computer program by performing arithmetic operations, logical operations, and input / output operations of the system. Instructions are provided to the processor 702 by memory 704.

[0077] One or more input / output devices 706 may be wired and may include components that interface the processor 702 with other input / output components. As can be understood, the programs stored in one or more input / output devices 706 and memory 704 may vary depending on the implementation of the computer system 700 in order to define specific functions of the computer system 700.

[0078] The one or more input / output devices 706 may also include one or more user input devices (e.g., keyboard, keypad, mouse, etc.) and user output devices (e.g., display, speaker, etc.).

[0079] 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 system for minimizing residual blood values ​​via plasma rinseback, the system is A collection bag configured to store plasma collected from a donor during the blood collection process, A return reservoir container configured to collect any fluid remaining in the system after the blood collection process is completed, One or more pumps configured to operate between an operating state and a non-operating state during the blood collection process and the plasma rinse-back process, The collection bag, the return reservoir container, the one or more pumps, and the one or more lines configured to connect the donor, Equipped with, The system is configured to perform the plasma rinse-back, which involves returning the fluid within the system to the donor after the blood collection process is completed. system.

2. In the system described in claim 1, The plasma rinse-back has a plasma outflow process, The aforementioned plasma outflow process is Opening the valve of the collection bag, For a predetermined time, the stored plasma is released from the collection bag, Closing the valve after the predetermined time, Includes, The stored plasma, which is to be released from the collection bag, is configured to flow into the return reservoir container by gravity. system.

3. In the system described in claim 2, The system is further configured to perform a plasma flush after the plasma rinse-back, The plasma flush includes operating a first pump among the one or more pumps to drain the plasma from the return reservoir until the lower sensor of the return reservoir detects air. The plasma is configured to flow from the return reservoir container through one or more lines to flush out any collected fluid remaining in the system after the blood collection process is complete and return it to the donor. system.

4. In the system described in claim 3, The residual blood value is the amount of the collected fluid remaining in the system after the plasma flush is completed. The plasma flush is configured to reduce the amount of the collected fluid remaining in the system after the plasma flush to below a threshold. system.

5. In the system according to claim 2, the system further: The system includes an alarm configured to activate if the valve is open for longer than the predetermined time. system.

6. In the system described in claim 1, The collection bag is configured to be positioned above the donor by a threshold distance. system.

7. In the system described in claim 1, The aforementioned system further, After the blood collection process is completed, the return reservoir container is monitored, If the amount of fluid in the return reservoir container exceeds a threshold amount, the first pump among the one or more pumps is operated to drain the fluid from the return reservoir container. Configured to perform, system.

8. In the system described in claim 7, The aforementioned system further, The system is configured to operate the first pump to return the fluid discharged from the return reservoir container back to the donor, Operating the first pump to return the fluid discharged from the return reservoir container back to the donor further includes pumping the fluid out of the channels of the system. system.

9. In the system described in claim 8, The system further comprises an anticoagulant source, The system is further configured such that, after the first pump pumps out fluid from the channel, the second and third pumps are operated to flow the anticoagulant from the anticoagulant source into the one or more lines and into the channel. system.

10. In the system described in claim 9, The plasma rinse-back is performed after the second and third pumps have flowed the anticoagulant through the one or more lines into the channel. system.

11. A method for minimizing residual blood values ​​via plasma rinseback, the method being The process includes a step of performing a blood collection process via an apheresis system. The apheresis system is, A collection bag configured to store plasma collected from a donor during the aforementioned blood collection process, A return reservoir container configured to collect the fluid remaining in the apheresis system after the blood collection process is completed, One or more pumps configured to operate between an operating state and a non-operating state during the blood collection process and the plasma rinse-back process, The device comprises the collection bag, the return reservoir container, the one or more pumps, and one or more lines configured to connect the donor. The above method further, The step of performing the plasma rinse-back, which involves returning the fluid in the apheresis system back to the donor after the blood collection process is completed, Having, method.

12. In the method according to claim 11, The step of performing the aforementioned plasma rinse-back is, The steps include opening the valve of the collection bag, The steps include: draining the stored plasma from the collection bag for a predetermined time; The steps include closing the valve after the predetermined time, It has, The stored plasma, which is released from the collection bag, is released by gravity into the return reservoir container. method.

13. In the method according to claim 12, the method further, The step includes performing a plasma flush after performing the aforementioned plasma rinse-back, The aforementioned plasma flush is The process includes the step of operating the first pump among the one or more pumps to drain the plasma from the return reservoir until the lower sensor of the return reservoir detects air, The plasma flows from the return reservoir container through the one or more lines, flushing away any collected fluid remaining in the apheresis system after the blood collection process is complete and returning it to the donor. method.

14. In the method described in claim 13, The residual blood value is the amount of the collected fluid remaining in the apheresis system after the plasma flush is completed. The plasma flush reduces the amount of the collected fluid remaining in the apheresis system after the plasma flush to below a threshold. method.

15. In the method described in claim 12, the method further: The system includes a step of activating an alarm if the valve is open for longer than the predetermined time. method.

16. In the method according to claim 11, The collection bag is configured to be positioned above the donor by a threshold distance. method.

17. In the method according to claim 11, the method further, The steps include monitoring the return reservoir container after the blood collection process is completed, If the amount of fluid in the return reservoir container exceeds a threshold amount, the first pump among the one or more pumps is operated to drain the fluid from the return reservoir container. Having, method.

18. In the method according to claim 17, the method further, The process includes the step of operating the first pump to return the fluid discharged from the return reservoir container back to the donor, The step of operating the first pump to return the fluid discharged from the return reservoir container to the donor includes the step of pumping the fluid out of the channels of the apheresis system. method.

19. In the method according to claim 18, the method further, The first pump has pumped fluid out of the channel, and the second and third pumps have been operated to flow the anticoagulant from the anticoagulant source into the channel through the one or more lines, method.

20. In the method according to claim 19, the step of performing the plasma rinse back is performed after the second pump and the third pump have flowed the anticoagulant into the channel through the one or more lines. method.

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