CN111465421B

CN111465421B - System and method for collecting plasma

Info

Publication number: CN111465421B
Application number: CN201880079926.0A
Authority: CN
Inventors: M·拉古萨
Original assignee: Haemonetics Corp
Current assignee: Haemonetics Corp
Priority date: 2017-10-25
Filing date: 2018-10-25
Publication date: 2024-03-08
Anticipated expiration: 2038-10-25
Also published as: RU2020116822A; KR20200078553A; JP7390287B2; EP3700606A4; KR20240017096A; KR102629919B1; CA3079851A1; SA520411828B1; CN117959513A; EP3700606A1; AU2018355417B2; WO2019084278A1; CN111465421A; JP2021500950A; AU2018355417A1; JP2023154074A; RU2020116822A3

Abstract

A method of collecting plasma comprising determining the weight, height and hematocrit of a donor and calculating a donor plasma volume and a target plasma collection volume. The target plasma collection volume is based on the donor plasma volume and the target percentage of plasma. The method then draws blood from the donor through a line connected to the blood component separation device and introduces an anticoagulant into the drawn blood. The blood component separation device separates blood into a plasma component and a second blood component, and the plasma component is collected from the blood component separation device and into a plasma collection container. The method may then calculate the volume of pure plasma collected in the plasma collection container and continue processing/collection until the calculated volume of pure plasma equals the target plasma collection volume.

Description

System and method for collecting plasma

Priority

This patent application claims priority from U.S. patent application Ser. No. 15/793,339 (attorney docket No. 130670-08003 (formerly 1611/C86) entitled "System and Method for Collecting Plasma", filed on even 25 at 10/2017, and by Michael Ragusa, inventor), the entire disclosure of which is incorporated herein by reference.

U.S. patent application Ser. No. 15/793,339, in turn, filed 5/30/2017, entitled "System and Method for Collecting Plasma" (attorney docket No. 130670-08002, previously 1611/C80), and filed Michael Ragusa inventor) continues to apply and claim all priority thereto, the entire disclosure of which is incorporated herein by reference.

Technical Field

The present invention relates to systems and methods for apheresis, and more particularly, to systems and methods for collecting plasma products.

Background

Apheresis is a procedure in which individual blood components can be separated and collected from whole blood temporarily drawn from a subject. Typically, whole blood is withdrawn through a needle inserted into a vein and cell separator (e.g., centrifugal bowl) of the subject's arm. Once the whole blood has been separated into its various components, one or more components (e.g., plasma) may be removed from the centrifuge bowl. The remaining ingredients may be returned to the subject with optional compensation fluid (to compensate for the volume of the ingredient removed). The process of extraction and return continues until a certain amount of the desired component is collected, and then the process is stopped. The main feature of the apheresis system is the return of the treated but unwanted components to the donor. The separated blood components may include, for example, high density components such as red blood cells, medium density components such as platelets or white blood cells, and low density components such as plasma.

Many jurisdictions have regulations regarding the amount of whole blood and/or blood components that can be removed from a donor. For example, the U.S. food and drug administration ("FDA") sets an upper limit on the volume of plasma that can be collected (e.g., 800 milliliters for an adult weighing over 175 pounds) and an upper limit on the total collection volume (e.g., 880 milliliters for an adult weighing over 175 pounds). The prior art plasma collection systems are unable to determine the total volume of collected plasma (e.g., because the collected product is a mixture of plasma and anticoagulant) and therefore collect based on the total collection volume, even though the total volume of collected plasma is below the FDA specified limit. In addition, the prior art collection systems do not tailor the amount of plasma collected to an individual (e.g., unlike the weight fractions to which they belong), and therefore the percentage of patient plasma collected varies greatly from patient to patient (e.g., for some patients only 23% of the plasma is collected, while for other patients 29% (or more) of the plasma is collected).

Summary of The Invention

According to some embodiments of the invention, a method for collecting plasma includes determining a body weight and hematocrit of a donor and inserting a venous access device into the donor. Once the venous-access device is inserted, the method may withdraw whole blood from the donor through the venous-access device and a withdrawal line connected to the blood component separation device. The method may then introduce an anticoagulant into the drawn whole blood through the anticoagulant line and separate the drawn whole blood into a plasma component and at least a second blood component using a blood component separation device. Once separated, the plasma component may be separated from the blood component separation device and collected into a plasma collection container. During processing, the method may calculate (1) the percentage of anticoagulant in the collected plasma component, and (2) the volume of pure plasma collected in the plasma collection container. The volume of pure plasma may be based at least in part on a calculated percentage of anticoagulant in the collected plasma components. The method may continue the process (e.g., drawing whole blood, introducing anticoagulant into the whole blood, separating the blood, collecting plasma, and calculating the percentage of anticoagulant and the volume of pure plasma) until a target volume of pure plasma is collected in the plasma collection container.

In some embodiments, the method may determine a change in volume in the anticoagulant container, and the calculated percentage of anticoagulant in the collected plasma may be based at least in part on the change in volume in the anticoagulant container. Additionally or alternatively, the method may determine the volume of anticoagulant introduced into the whole blood based on the number of revolutions of the anticoagulant pump. In such embodiments, the calculated percentage of anticoagulant in the collected plasma may be based at least in part on the number of revolutions of the anticoagulant pump. The method may also determine a volume of anticoagulant in the blood component separation device, and the calculated percentage of anticoagulant in the collected plasma may be based at least in part on the volume of anticoagulant in the blood component separation device.

In further embodiments, the method may monitor the volume and/or weight of the collected plasma component in the plasma collection container (e.g., using a weight sensor), and the calculated volume of pure plasma collected in the plasma collection device may be based at least in part on the monitored volume and/or weight of the collected plasma component. Additionally or alternatively, determining the hematocrit of the donor may include monitoring the volume of red blood cell collection in the blood separation device. In such embodiments, the determined hematocrit of the donor may be based at least in part on the monitored volume of red blood cells collected in the blood separation device and the volume of whole blood drawn from the donor.

The target volume of pure plasma may be based at least in part on the body weight of the donor. The percentage of anticoagulant in the collected plasma components may include at least a portion of the anticoagulant introduced into the drawn blood and at least a portion of the volume of anticoagulant added to the system during the priming step. After collecting at least a portion of the target volume of pure plasma, the method may return the second blood component to the donor through a return line.

According to further embodiments, a system for collecting plasma comprises: venous access device for drawing whole blood from a subject and returning blood components to the subject; and a blood component separation device for separating the extracted blood into a plasma component and a second blood component. The blood component separation device has an outlet and is configured to deliver a plasma component to a plasma container. The system may also include a blood withdrawal line fluidly connected to the venous access device and an anticoagulant line connected to an anticoagulant source. The blood withdrawal line conveys the withdrawn whole blood to the blood component separation device, and the flow rate through the blood withdrawal line can be controlled by the blood withdrawal pump. An anticoagulant line may introduce anticoagulant into the drawn whole blood.

Additionally, the system may include a controller that controls the operation of the centrifugal drum. The controller may also calculate (1) the percentage of anticoagulant in the collected plasma component, and (2) the volume of pure plasma collected in the plasma container. The volume of pure plasma may be based at least in part on the percentage of anticoagulant in the collected plasma components. The controller may stop the blood pump when a target volume of pure plasma (e.g., based at least in part on the weight of the donor) is collected in the plasma container. In some embodiments, the percentage of anticoagulant in the collected plasma component may be based at least in part on the volume of anticoagulant added to the drawn whole blood and the hematocrit of the subject.

The system may further include an anticoagulant source weight sensor that measures the weight of the anticoagulant source. The controller may monitor a change in volume in the anticoagulant container based on the measured weight of the anticoagulant source, and the calculated percentage of anticoagulant in the collected plasma may be based at least in part on the change in volume within the anticoagulant source. Additionally or alternatively, the controller may monitor the number of revolutions of the anticoagulant pump to determine the volume of anticoagulant introduced into the whole blood. In such embodiments, the calculated percentage of anticoagulant in the collected plasma may be based at least in part on the number of revolutions of the anticoagulant pump.

In some embodiments, the system may include an optical sensor located on the blood component separation device. The optical sensor may monitor the contents of the blood component separation device and determine whether a volume of anticoagulant remains in the blood component separation device. The calculated percentage of anticoagulant in the collected plasma may be based at least in part on the volume of anticoagulant in the blood component separation device.

In further embodiments, the system may further comprise a plasma container weight sensor that monitors the volume and/or weight of the plasma component collected in the plasma collection container. The calculated volume of pure plasma collected in the plasma collection container may be based at least in part on the monitored volume and/or weight of the collected plasma components. The system may also have an optical sensor located on the blood component separation device. The optical sensor may monitor the volume of red blood cells collected in the blood separation device. The controller may then determine the hematocrit of the subject based at least in part on the monitored volume of red blood cells collected in the blood separation device and the volume of whole blood drawn from the donor. The percentage of anticoagulant in the collected plasma components may include at least a portion of the anticoagulant introduced into the drawn blood and at least a portion of the volume of anticoagulant added during the filling step.

According to further embodiments, a method for collecting plasma determines a weight, height, and hematocrit of a donor, and calculates a donor plasma volume based at least in part on the weight, height, and hematocrit of the donor. The method then calculates a target plasma collection volume based at least in part on the calculated donor plasma volume and a target percentage of plasma (e.g., 26.5% to 29.5% of the donor plasma volume), and draws whole blood from the donor through the venous-access device and a first line connected to the blood component separation device. As whole blood is drawn, the method may introduce anticoagulant into the drawn whole blood through an anticoagulant line.

The blood component separation device separates the drawn whole blood into a plasma component and at least a second blood component, and the method may collect the blood component from the plasma component separation device into a plasma collection container. During processing, the method may calculate the volume of pure plasma collected in the plasma collection container. The method continues with the steps of withdrawing, introducing anticoagulant, separating, collecting, and calculating until the volume of pure plasma collected in the plasma collection container is equal to the target plasma collection volume.

In some embodiments, after collecting at least a portion of the target plasma collection volume, the method may return the contents of the blood component separation device to the donor through the first line. Additionally or alternatively, the method may calculate the intravascular insufficiency based at least in part on the volume of the collected pure plasma and the volume of the contents of the blood component separation device returned to the donor. The method may also return a volume of saline to the donor to obtain the target intravascular insufficiency. The target intravascular deficiency may be-250 to 500 milliliters (e.g., may be 0 milliliters or 250 milliliters). The donor plasma volume may be calculated based at least in part on the body mass index of the donor, which in turn is calculated based on the weight and height of the donor.

In further embodiments, the method may include calculating the percentage of anticoagulant in the collected plasma component. In such embodiments, the volume of pure plasma may be based at least in part on the calculated percentage of anticoagulant in the collected plasma components. The calculated percentage of anticoagulant in the collected plasma may be based at least in part on a change in volume in the anticoagulant container, a number of revolutions of the anticoagulant pump, and/or a volume of anticoagulant in the blood component separation device. The method may determine a change in volume in the anticoagulant container, a volume of anticoagulant introduced into the whole blood, and/or a volume of anticoagulant in the blood component separation device. The percentage of anticoagulant in the collected plasma component may include at least a portion of the anticoagulant introduced into the drawn blood and at least a portion of the volume of anticoagulant added during the filling step.

In some embodiments, the method may include monitoring the volume or weight of the plasma component collected in the plasma collection container. In such embodiments, the calculated volume of pure plasma collected in the plasma collection device may be based at least in part on the monitored volume and/or weight of the collected plasma component. To determine the hematocrit of the donor, the method may monitor the volume of red blood cells collected in the blood separation device. The hematocrit of the donor may be based at least in part on the monitored volume of red blood cells collected in the blood separation device and the volume of whole blood drawn from the donor.

According to further embodiments, a system for collecting plasma includes a venous access device for drawing whole blood from a subject and returning blood components to the subject; and a blood component separation device for separating the extracted blood into a plasma component and a second blood component. The blood component separation device may have an outlet and may deliver the plasma component to the plasma container. The system may also have a first line and an anticoagulant line. The first line may be fluidly connected to the venous-access device and may (1) deliver the drawn whole blood to the blood component separation device and (2) return fluid in the blood component separation device to the subject. The flow through the first line may be controlled by the first pump. An anticoagulant line may be connected to the anticoagulant source and an anticoagulant may be introduced into the drawn whole blood.

The system may further include a controller that controls operation of the centrifugal bowl and the first pump. The controller may calculate (1) a donor plasma volume, (2) a target plasma collection volume, and (3) a volume of pure plasma collected in the plasma container. The donor plasma volume may be based at least in part on the weight and height of the donor and the hematocrit of the donor. The target plasma collection volume may be based at least in part on the calculated donor plasma volume and the target percentage of plasma. The volume of pure plasma collected in the plasma container may be based at least in part on the percentage of anticoagulant in the collected plasma components. The controller may stop the first pump when the calculated volume of pure plasma collected in the plasma collection container is equal to the target plasma collection volume.

In a further embodiment, the controller may return fluid remaining in the blood component separation device through the first line after collecting at least a portion of the target plasma collection volume. Additionally or alternatively, the controller may calculate the intravascular deficiency based at least in part on the volume of the collected pure plasma and the volume of the contents of the blood component separation device returned to the donor. The system may also include a saline line fluidly connected to the saline source and the blood component separation device. The controller may return a volume of saline to the donor to achieve the target intravascular insufficiency (e.g., -250 to 500 milliliters).

The controller may calculate a body mass index of the donor based at least in part on the weight and height of the donor. Further, the donor plasma volume may be calculated based at least in part on the body mass index of the donor. The target percentage of plasma may be 26.5% to 29.5% (e.g., 28.5%) of the donor plasma volume.

In further embodiments, the controller may calculate the percentage of anticoagulant in the collected plasma component, for example, based on the volume of anticoagulant added to the drawn whole blood and the hematocrit of the subject. The system may further include an anticoagulant source weight sensor that measures the weight of the anticoagulant source. The controller may then monitor the volume change in the anticoagulant container based on the measured weight of the anticoagulant source. The calculated percentage of anticoagulant in the collected plasma may be based at least in part on the change in volume within the anticoagulant source. Additionally or alternatively, the controller may monitor the number of revolutions of the anticoagulant pump to determine the volume of anticoagulant introduced into the whole blood. In such embodiments, the calculated percentage of anticoagulant in the collected plasma may be based at least in part on the number of revolutions of the anticoagulant pump.

The system may further comprise an optical sensor and/or a plasma container weight sensor. The optical sensor may be located on the blood component separation device and may monitor the contents of the blood component separation device to determine if a volume of anticoagulant remains in the blood component separation device. The calculated percentage of anticoagulant in the collected plasma may then be based at least in part on the volume of anticoagulant in the blood component separation device. The plasma container weight sensor may monitor the volume and/or weight of the plasma component collected in the plasma container. The volume of pure plasma collected in the plasma collection device may then be calculated based at least in part on the volume and/or weight of the monitored plasma component. The optical sensor may also monitor a volume of red blood cells collected in the blood separation device, and the controller may determine a hematocrit of the subject based at least in part on the monitored volume of red blood cells collected in the blood separation device and a volume of whole blood drawn from the donor. The percentage of anticoagulant in the collected plasma component may include at least a portion of the anticoagulant introduced into the blood and at least a portion of the volume of anticoagulant added during the filling step.

Brief description of the drawings

The foregoing features of the invention will be more readily understood by reference to the following detailed description, taken with the accompanying drawings, in which:

fig. 1 schematically illustrates a perspective view of a blood processing system according to some embodiments of the invention.

FIG. 2 schematically illustrates a top view of the blood processing system of FIG. 1, in accordance with some embodiments of the present invention;

fig. 3 schematically illustrates a disposable set installed within the blood processing system of fig. 1, according to some embodiments of the invention.

Fig. 4 is a flow chart depicting a method of collecting plasma according to an embodiment of the invention.

Fig. 5 is a flow chart depicting an alternative method of collecting plasma according to other embodiments of the invention.

Detailed description of the specific embodiments

Illustrative embodiments of the present invention provide blood processing systems and methods for collecting a target volume of pure plasma. The systems and methods calculate the percentage of anticoagulant collected in the plasma collection container (e.g., in addition to the plasma collected in the container) based on the amount of anticoagulant added to the system and the hematocrit of the donor. The system/method may then calculate the volume of pure plasma (e.g., plasma without anticoagulant) that has been collected in the container. Further embodiments may adjust the volume of plasma collected based on the plasma volume of the donor and the target percentage of plasma to be collected. Details of the illustrative embodiments are discussed below.

As shown in fig. 1 and 2, blood processing system 100 includes a housing 110, housing 110 containing the main components (e.g., non-disposable components) of system 100. Within housing 110, system 100 may include a first/blood pump 232 that draws whole blood from a subject and a second/anticoagulant pump 234 that pumps anticoagulant through system 100 and into the drawn whole blood. Additionally, the system 100 may include a plurality of valves that may be opened and/or closed to control fluid flow through the system 100. For example, the system 100 may include a donor valve 120 that may be opened and closed to selectively block and allow fluid flow through a donor line 218 (e.g., inlet line; fig. 3), and a plasma valve 130 that selectively blocks and allows fluid flow through an outlet/plasma line 222 (fig. 3). Some embodiments may also include a brine valve 135 that selectively prevents and allows brine to flow through the brine line 223.

To facilitate connection and installation of the disposable set and support of the respective fluid containers, the system 100 can include an anticoagulant wand 150 and a saline wand 160, an anticoagulant solution container 210 (fig. 3) can be suspended from the anticoagulant wand 150, and a saline solution container 217 (fig. 3) can be suspended from the saline wand 160 (e.g., if the procedure being performed requires the use of saline). Additionally, in some applications, it may be necessary and/or desirable to filter whole blood drawn from a subject for processing. To this end, the system 100 may include a blood filter holder 170 in which a blood filter (located on a disposable set) may be placed.

As discussed in more detail below, the apheresis system 100 according to embodiments of the invention uses a blood pump 232 to draw whole blood from a subject through the venous access device 206 (fig. 3). As the system 100 draws whole blood from a subject, the whole blood enters a blood component separation device 214, such as a Latham centrifuge (other types of separation chambers and devices may be used, such as, but not limited to, integrally blow-molded centrifugal drums, as described in U.S. Pat. nos. 4,983,158 and 4,943,273, which are incorporated herein by reference). The blood component separation device 214 separates whole blood into its constituent components (e.g., red blood cells, white blood cells, plasma, and platelets). Thus, to facilitate operation of the separation device 214, the system 100 may further include a compartment 180 in which the separation device 214 may be placed and in which the separation device 214 rotates (e.g., to create centrifugal force required to separate whole blood).

To allow a user/technician to monitor the system operation and control/set various parameters of the program, the system 100 may include a user interface 190 (e.g., a touch screen device) that presents operating parameters, any alert messages, and buttons that the user/technician may press to control the various parameters. Other components of the blood processing system 100 are discussed in more detail below (e.g., with respect to system operation).

Fig. 3 is a schematic block diagram of a blood processing system 100 and a disposable collection set 200 (having an inlet disposable set 200A and an outlet disposable set 200B) that may be loaded onto/into the blood processing system 100 according to the present invention. The collection kit 200 includes a venous access device 206 (e.g., a venous lancet) for drawing blood from a donor's arm 208, an anticoagulant container 210, a centrifuge bowl 214 (e.g., a blood component separation device), a saline container 217, and a final plasma collection bag 216. The blood/inlet line 218 couples the venous access device 206 to the inlet end 220 of the bowl 214, the plasma/outlet line 222 couples the outlet end 224 of the bowl 214 to the plasma collection bag 216, and the saline line 223 connects the outlet end 224 of the bowl 214 to the saline container 217. An anticoagulant line 225 connects anticoagulant container 210 to inlet line 218. In addition to the components described above and as shown in fig. 3, the blood processing system 100 also includes a controller 226, a motor 228, and a centrifuge chuck 230. The controller 226 is operably coupled to two pumps 232 and 234 and a motor 228, which in turn drives a chuck 230. The controller 226 may be operably coupled to and in communication with the user interface 190.

In operation, the disposable collection set 200 (e.g., the inlet disposable set 200A and the outlet disposable set 200B) may be loaded onto/into the blood processing system 100 prior to blood processing. In particular, blood/inlet line 218 routes through blood/first pump 232, and anticoagulant line 225 from anticoagulant container 210 routes through anticoagulant/second pump 234. The centrifugal drum 214 may then be securely loaded into the chuck 230. Once the drum 214 is secured in place, the technician may install the disposable outlet set 200B. For example, a technician may connect the bowl connector 300 to the outlet 224 of the bowl 214, install the plasma container 216 into the weight sensor 195, pass the saline line 223 through the valve 135, and pass the plasma/outlet line 222 through the valve 130 and the line sensor 185. Once the disposable set 200 is installed and the anticoagulant and saline container 210/217 are connected, the system 100 is ready to begin blood processing.

Fig. 4 is a flow chart depicting an exemplary method of collecting plasma in accordance with various embodiments of the present invention. Before connecting the donor to the blood processing apparatus 100, it may be beneficial (in some cases necessary) to obtain/determine certain information about the donor, namely the weight of the donor (step 410) and the hematocrit (step 415). This information not only helps to determine whether an individual is a viable donor, but also helps to determine the volume of blood components that can be drawn/collected (e.g., according to FDA guidelines), hematocrit can be used during processing to help collect a target volume of plasma. The technician may obtain/determine the weight of the donor by weighing the donor (e.g., on a scale). To obtain/determine the hematocrit of the donor, the technician may draw a blood sample from the donor and test the blood sample. Additionally or alternatively, as discussed in more detail below, the system may determine hematocrit during blood processing. For example, the blood processing apparatus 100 may include a hematocrit sensor (not shown) that determines the hematocrit of blood flowing into the blood processing apparatus 100 and/or the system 100 may determine the hematocrit based on the volume of red blood cells collected within the drum 214.

Once the lines 222/223 are in place and the technician has determined the weight and/or hematocrit of the donor (if desired), the user/technician may insert the venous access device 206 into the donor's arm 208 (step 420). Next, the controller 226 activates the two pumps 232, 234 and the motor 228. Operation of the two pumps 232, 234 causes whole blood to be drawn from the donor (step 425), anticoagulant from the container 210 to be introduced into the drawn whole blood (step 430), and the anticoagulated whole blood will now be delivered to the inlet end 220 of the drum 214.

It should be noted that anticoagulant line 225 can also include a bacterial filter (not shown) that prevents any bacteria in anticoagulant source 210, anticoagulant, or anticoagulant line 225 from entering system 100 and/or the subject. Additionally, the anticoagulant line 225 can include an air detector 140, which air detector 140 detects the presence of air within the anticoagulant. The presence of bubbles within any system 100 pipeline can be problematic for the operation of the system 100 and can also be detrimental to the subject if the bubbles enter the blood stream. Thus, the air detector may be connected to an interlock that stops flow within the anticoagulant line 225 (e.g., by stopping the anticoagulant pump 234) in the event that a bubble is detected, thereby preventing the bubble from entering the subject.

When the anticoagulated whole blood is withdrawn from the subject and contained in the blood component separation device 214, the blood component separation device 214 separates the whole blood into several blood components (step 435). For example, the blood component separation device 214 may separate whole blood into first, second, third, and possibly fourth blood components. More specifically, the blood component separation device 214 (and the centrifugal force generated by the rotation of the separation device 214) is capable of separating whole blood into plasma, platelets, red blood cells ("RBCs"), and possibly white blood cells ("WBCs"). The higher density component (i.e., RBCs) is forced to the outer wall of the bowl 214, while the lower density plasma is more central. Buffy coat forms between plasma and RBC. The buffy coat consists of an inner layer of platelets, a transitional layer of platelets and WBCs, and an outer layer of WBCs. Plasma is the component closest to the outlet end and is the first fluid component that exits the bowl 214 through the outlet end 224 as additional anticoagulated whole blood enters the bowl 214 through the inlet end 220.

As shown in fig. 3, the system 100 may also include an optical sensor 213, which optical sensor 213 may be applied to a shoulder of the drum 214. The optical sensor monitors each layer of blood components as they gradually and coaxially advance from the outer wall of the drum 214 toward the center. The optical sensor 213 may be mounted in a location where it is capable of detecting buffy coat and/or red blood cells reaching a particular radius (e.g., within the chamber 180), and in response to the detection, the step of drawing whole blood from the subject/donor and introducing the whole blood into the drum 12 may be altered and/or terminated.

Additionally, in some embodiments, the optical sensor 213 may be used to determine the hematocrit of the donor during processing. For example, when the drum 214 is filled with red blood cells and the optical sensor 213 detects a red blood cell layer, the system 100 (e.g., a controller) can determine the volume of red blood cells within the drum 214 based on the location of the red blood cell layer and the fixed/known drum volume. The system 100 may then calculate the donor hematocrit based on the volume of red blood cells within the bowl and the volume of whole blood that has been processed at this time.

Once the blood component separation device 214 separates the blood into various components, one or more components may be removed from the blood component separation device 214. For example, plasma may be withdrawn via line 222 to a plasma container 216 (e.g., a plasma bottle) (step 440). As described above, some embodiments of the system 100 may include a weight sensor 195 (fig. 1) that measures the amount of plasma collected. The plasma collection process may continue until a target volume of pure plasma is collected within plasma collection container 216 (discussed in detail below). Although not shown, if the blood processing system 100 and/or disposable set 200 includes a platelet, red blood cell, and/or white blood cell bag, each bag/container may include a similar weight sensor (e.g., a load cell).

In some embodiments, the system 100 may also include an in-line sensor 185 (as described above) that may determine the type of fluid (e.g., plasma, platelets, red blood cells, etc.) exiting the blood component separation device 214. In particular, the line sensor 185 consists of an LED that emits light through the blood component exiting the drum 214 and a light detector that receives the light after it passes through the component. The amount of light received by the light detector is related to the density of the fluid passing through the pipeline. For example, if plasma is exiting the drum 214, the line sensor 185 will be able to detect when the plasma exiting the drum 214 becomes cloudy due to platelets (e.g., the fluid exiting the drum 214 changes from plasma to platelets). The system 100 may then use this information to stop the removal of blood components from the bowl 214, stop the extraction of whole blood from the subject, or redirect flow by, for example, closing one valve and opening the other.

It is important to note that the osmotic pressure of the red blood cells prevents the anticoagulant introduced into the whole blood from entering/remaining with the red blood cells (e.g., within the bowl 214) during processing. In contrast, anticoagulants are mixed with the plasma component. Thus, the anticoagulant leaves the drum 214 with the plasma and is collected in the collection container 216 with the plasma. In other words, the product weight measured by the weight sensor 195 is the weight of the plasma and any anticoagulants mixed with the plasma, i.e., the weight provided by the weight sensor 195 is not the weight of pure plasma.

Furthermore, whole blood contains a variable amount of plasma, depending on the hematocrit of the donor. The hematocrit of a typical donor may vary between 38% and 54%, meaning that the volume of plasma may vary between 36ml and 62ml for 100ml of whole blood. Furthermore, the amount of anticoagulant added to the drawn whole blood is fixed (e.g., it is not dependent on the donor's hematocrit), which means that the percentage of anticoagulant in the collected plasma can vary between 9.7% and 12.7% for 38% to 54% of donor hematocrit, respectively. Thus, not only does the volume measured by the weight sensor 195 include the volume of anticoagulant, but the volume of anticoagulant can vary between donors based on hematocrit.

As described above, some embodiments of the invention continue the blood processing/separation procedure until a target volume of pure plasma (e.g., only plasma (the volume of any anticoagulant that is not mixed with the plasma in the target volume)) is collected within the plasma collection container 216. To this end, some embodiments of the invention may calculate the volume of pure plasma within the plasma collection container 216. For example, a technician or system 100 (e.g., a controller) may calculate the percentage of anticoagulant in the collected plasma (e.g., the plasma contained in the plasma collection container 216) based on the amount of anticoagulant added/metered to the whole blood and the hematocrit of the donor (step 455). The technician and/or system may calculate the percentage of anticoagulant according to the following formula, where AC is the amount of anticoagulant added to the system 100. As described above, substantially all anticoagulant leaves the drum 214 and is collected with the plasma within the plasma collection container 216 due to the osmotic pressure of the red blood cells.

The amount of anticoagulant added to the system 100 can be determined in a number of ways. For example, the system 100 may establish an amount of anticoagulant (e.g., the value of "AC" in the above formula) based on a predetermined ratio of anticoagulant per unit of anticoagulated whole blood. In some embodiments, the value of "AC" may be the inverse of the predetermined ratio (e.g., if the ratio of anticoagulant to anticoagulated whole blood is 1:16, "AC" would be 16). Additionally or alternatively, the technician/system 100 may monitor the amount of anticoagulant added to the system. In such embodiments, the technician/system can monitor the volume of anticoagulant added to the system 100 based on the number of revolutions of the anticoagulant pump (e.g., each revolution of the anticoagulant pump introducing a set volume of anticoagulant into the system 100) and/or based on a change in weight of the anticoagulant container 210 as measured by a weight sensor (discussed in more detail below).

Once the technician/system 100 has calculated the percentage of anticoagulant within the plasma collection container 216, the technician/system 100 may use this information to calculate the volume of pure plasma within the plasma collection container 216 (step 465). For example, the technician/system 100 may determine the volume of anticoagulant in the container (based on the percentage of anticoagulant within the container 216) and subtract that volume from the total volume of fluid within the container 216 as measured by the weight sensor 195. The system 100 may continue to monitor the volume of pure plasma collected within the container 216 and continue to process whole blood (e.g., continue to perform steps 425, 430, 435, 440, 455, 460, and 465) until a target volume (step 470) of pure plasma is collected within the plasma collection container 216 (e.g., 800mL or other limits specified by the FDA or similar regulatory agency for adult donors weighing over 175 lbs).

Once the system 100 has collected the target volume of pure plasma in the plasma collection container 216, the system 100 may return the remaining components (e.g., the components remaining within the drum 214) to the subject (step 475). For example, when all plasma is withdrawn and the bowl 214 is filled with RBCs (and any other blood components not collected), the controller 226 stops drawing whole blood from the subject and reverses the direction of the blood/first pump 232 to draw RBCs (and other components) directly back from the bowl 214 to the subject. Alternatively, if the system 100 is so equipped with a dedicated return line, the system may return the ingredients to the subject via the dedicated return line.

In addition to uncollected blood components (e.g., components remaining in the bowl 214), the system 100 may also return saline to the patient/subject. Saline may be used as a compensation fluid to compensate for the volume of blood components (e.g., plasma) that are removed and collected and not returned to the patient. To this end, during the return step (e.g., step 475), the saline valve 135 may be opened to allow saline from the saline container 217 to flow through the saline line 223 and into the bowl 214 (through the outlet 224), where it may be returned to the patient/donor along with or after the remaining blood components.

It should be noted that some embodiments may perform some additional and optional steps to help determine the volume of pure plasma within the plasma collection container 216. For example, as described above, some embodiments may monitor the weight change of the anticoagulant container 210 (e.g., as measured by a weight sensor/load cell on the anticoagulant container 210) (step 445). This measurement provides an indication of the volume of anticoagulant that has been added to the system 100 and can be used to help determine the percentage of anticoagulant within the plasma collection container 216. Additionally or alternatively, some embodiments may similarly monitor the change in weight and/or volume of plasma and anticoagulant collected within plasma collection container 216 (e.g., via weight sensor 195) (step 450). This measurement may be used to calculate the total volume of pure plasma collected within plasma collection container 216 (e.g., to obtain the total weight from which to subtract the calculated anticoagulant volume).

Some embodiments may also (optionally) monitor the volume of anticoagulant remaining in the bowl 214 (step 460) (e.g., anticoagulant that is not mixed with plasma and/or otherwise remains in the bowl). For example, the system 100 can utilize an optical sensor on the drum 214 to determine if any anticoagulant remains within the drum 214. If indeed present, the method 400/system 100 may modify the calculation of the amount of pure plasma collected in the plasma collection container (e.g., increase the calculated amount or decrease the calculated amount) based on the volume of anticoagulant remaining within the bowl 214.

The various embodiments of the present invention described above provide a number of benefits over prior art plasma collection systems. In particular, as described above, prior art plasma exchange devices end plasma collection based on the total volume of anticoagulated plasma (e.g., pure plasma plus added anticoagulant). Although this is the simplest method, since it only requires weighing the product collection container, the amount of authentic product (pure plasma) depends on the hematocrit of the donor. In other words, the prior art system will collect more plasma from low hematocrit donors than from high hematocrit donors due to the variation in the percentage of anticoagulant in the product. Various embodiments of the present invention address the problems of prior art systems by collecting a standard volume (e.g., a target volume) of pure plasma from each donor. As described above, embodiments of the present invention accomplish this by using the hematocrit of the donor and the amount of anticoagulant collected within the plasma collection container 216 (e.g., by counting the rotation of the pump and/or using a scale/weight sensor, etc.) to determine the percentage of anticoagulant in the product. In addition, by stopping the plasma collection process based on the volume of pure plasma collected, embodiments of the present invention are able to collect a greater volume of plasma than prior art systems that were stopped based on a plasma/anticoagulant mixture.

Fig. 5 shows another method of collecting plasma using the system shown in fig. 1-3 (or a similar system) that establishes the total volume of plasma to be collected based on an individual donor (e.g., based on his height, weight, hematocrit, and/or plasma volume). In a similar manner as described above for the method shown in fig. 4, the system/method may acquire/determine some information about the donor, i.e., the weight and height of the donor (step 505) and the hematocrit (step 510), prior to connecting the donor to the blood processing apparatus 100. For example, a technician may obtain/determine the weight of the donor by weighing the donor (e.g., on a scale), and obtain the height of the donor by measuring the donor. To obtain/determine the hematocrit of the donor (e.g., in a similar manner as described above), the technician may use the hematocrit sensor and/or test the blood sample based on the volume of red blood cells collected within the drum 214, and may use the hematocrit sensor during blood processing and/or determine the hematocrit based on the volume of red blood cells collected within the drum 214.

Using the height and weight of the donor and the hematocrit, the system 100/method 500 may calculate a plasma volume of the donor (e.g., the volume of plasma within the donor's blood) (step 515). For example, the system 100/method 500 may use the height and weight of the donor to calculate a body mass index ("BMI") of the donor/subject (e.g., BMI = weight/height ² ) The calculated BMI is then used to calculate the total blood volume within the donor/subject (see, e.g., lemmens et al, estimating Blood Volume in Obese and Morbidly Obese Patients, obelty Surgery,2006:16,773-776, the subject matter being incorporated herein by reference). The total blood volume can be calculated using the following formula:

in the above formula, inBV is the indexed blood volume (e.g., total blood volume of donor), BMip is the BMI of the patient (e.g., kg/m ² ) 22 is the BMI value (e.g., also in kg/m) for an Ideal Body Weight (IBW) ² In units), whereas 70 is the ideal weight of the donor (bmi=22 kg/m) ² ) Total blood volume at time (mL/kg). Once the system 100 has calculated the total blood volume within the donor/subject, the system 100 (e.g., the controller) may then determine/calculate the plasma volume within the donor's blood based on, for example, the donor's hematocrit (step 515).

As described above, the embodiment shown in fig. 5 establishes the volume of plasma to be collected based on the individual donor. To this end, once the system 100/method 500 determines the plasma volume of the donor, the system 100/method 500 may then calculate a target plasma volume to be collected (step 520). For example, the system 100/method 500 may multiply the total plasma volume in the patient by the target percentage of plasma to be collected to obtain the target plasma volume to be collected (e.g., if the total plasma volume is 2700ml and the target percentage to be collected is 28.5%, the target plasma volume to be collected is 769.5 ml). The target percentage of plasma to be collected may depend on the application and/or donor, and may be directly input into the system 100 (e.g., using the user interface 190), or may be preset by the factory. In some embodiments, the target percentage may be 26.5% to 30%, and preferably may be 28.5%. However, in other embodiments, the target percentage may be less than 26.5% or greater than 30%.

Once the lines 222/223 are in place and the system 100/method 500 has calculated the target plasma volume, the user/technician may insert the venous access device 206 into the donor's arm 208 (step 525). Next, the controller 226 activates the two pumps 232, 234 and the motor 228 in a similar manner as described above for the method shown in fig. 4. Operation of the two pumps 232, 234 causes whole blood to be drawn from the donor (step 530), anticoagulant from the container 210 is introduced into the drawn whole blood (step 535), and the anticoagulated whole blood will now be delivered to the inlet end 220 of the drum 214.

As the anticoagulated whole blood is withdrawn from the subject and introduced into the blood component separation device 214, the blood component separation device 214 separates the whole blood into individual blood components (e.g., into plasma, platelets, RBCs, and possibly WBCs) (step 540). As described above, the higher density component (i.e., RBCs) is forced to the outer wall of the bowl 214, and plasma is the component closest to the outlet end and thus the first fluid component to be expelled from the bowl 214 through the outlet end 224 as additional anticoagulated whole blood enters the bowl 214 through the inlet end 220. During separation and processing, the optical sensor 213 monitors each layer of blood components (as they gradually and coaxially advance from the outer wall of the drum 214 toward the center), and may alter and/or terminate the step of drawing whole blood from the subject/donor and introducing the whole blood into the drum 12 in response to the detection. Additionally, as described above, the optical sensor 213 can be used to determine the hematocrit of the donor during the treatment (e.g., if it is unknown and/or undetermined prior to beginning the treatment).

Once the blood component separation device 214 separates the blood into various components, the plasma may be moved to a plasma container 216 (e.g., a plasma bottle) via line 222 (step 545). As described above, some embodiments of the system 100 may include a weight sensor 195 (fig. 1) that measures the amount of plasma collected. The plasma collection process may continue until a target plasma collection volume (discussed in more detail below) is collected within plasma collection container 216. If equipped with an in-line sensor 185, the system 100 can then use information from the sensor 185 to stop the removal of blood components from the bowl 214, stop the extraction of whole blood from the subject, or redirect flow by, for example, closing one valve and opening the other.

As described above, some embodiments of the present invention continue the blood treatment/separation procedure until the target plasma collection volume is collected. To ensure that this volume does not include the volume of any anticoagulant collected within container 216, the target plasma collection volume should include only the volume of pure plasma (e.g., only plasma, i.e., the volume in the target volume that does not include any anticoagulant mixed with plasma). To this end, in a manner similar to that described above, some embodiments of the invention may calculate the volume of pure plasma within the plasma collection container 216. To determine the volume of pure plasma, the technician or system 100 (e.g., the controller) may calculate the percentage of anticoagulant in the collected plasma (e.g., the plasma contained in the plasma collection container 216) based on the amount of anticoagulant added/metered to the whole blood and the hematocrit of the donor (step 560) (see the formulas provided above). The amount of anticoagulant added to the system 100 can be determined in any of the ways described above (e.g., by monitoring the volume of anticoagulant added to the system, etc., based on a predetermined ratio of anticoagulant per unit of anticoagulated whole blood).

Once the technician/system 100 has calculated the percentage of anticoagulant within the plasma collection container 216, the technician/system 100 may use this information to calculate the volume of pure plasma within the plasma collection container 216 (step 570). For example, as described above, the technician/system 100 may determine the volume of anticoagulant in the container (based on the percentage of anticoagulant within the container 216) and subtract that volume from the total volume of fluid within the container 216 as measured by the weight sensor 195. The system 100 may continue to monitor the amount of pure plasma collected within the container 216 and continue to process whole blood (e.g., continue to perform steps 530, 535, 540, 545, 560, 570 and possibly steps 550, 555 and 565) until the pure plasma volume collected in the plasma collection container 216 reaches a target plasma volume (step 575) (e.g., calculated based on the individual plasma volume of the donor and the target percentage of plasma to be collected).

Once the system 100 has collected the target plasma volume within the plasma collection container 216, the system 100 may return the remaining components (e.g., the components remaining within the bowl 214) to the subject (step 580) by stopping the drawing of whole blood from the subject and reversing the direction of the blood/first pump 232 to draw RBCs (and other components) back from the bowl 214 to the subject (e.g., directly via the blood/inlet line 218 or via a dedicated return line if so equipped).

It is important to note that because the system 100/method 500 collects and does not return some blood components (e.g., plasma), the volume of fluid returned to the donor/subject is less than the volume that has been removed. This in turn produces an intravascular deficiency equal to the amount of plasma collected (e.g., the volume of whole blood removed from the donor minus the volume of plasma collected/not returned). In the case of an intravascular insufficiency that is too large, the procedure is completed and the donor is at risk of syncope when they get up from the facility. As described above, to reduce intravascular insufficiency (and risk of donor injury), some embodiments of the invention return saline to the patient/subject (step 585). Saline may be used as a compensation fluid to compensate for the volume of blood component (e.g., plasma) removed. To this end, during a return step (e.g., step 580), the controller 226 (or technician) may open a saline valve to allow saline from the saline container 217 to flow through the saline line 223 and into the bowl 214 (through the outlet 224), where it may be returned to the patient/donor along with or after the remaining blood components.

As described above, the volume of plasma collected from the donor varies from donor to donor (e.g., because the volume of plasma is based on the height, weight, hematocrit, and blood volume of the donor). Thus, the volume of saline returned to the donor to reduce intravascular insufficiency may similarly depend on the donor. To this end, when the contents of the separation device and saline are returned to the donor (steps 580 and 585), the system 100/method 500 may calculate an intravascular deficiency based on the volume of returned blood components and saline (or based on the volume of collected plasma and the volume of returned blood components and saline) from the total volume of whole blood removed from the donor (step 590). The system 100/method 500 may continue to return saline until the intravascular insufficiency of the donor reaches the target intravascular insufficiency (step 595).

The target intravascular insufficiency may be any intravascular insufficiency that reduces the risk of donor syncope and may be the same for each donor. For example, the target intravascular insufficiency of each donor may be set to 0mL or 250mL. Alternatively, the target intravascular insufficiency for each donor may be different, similar to the target plasma volume to be collected. In other words, for some donors, the target intravascular insufficiency may be set to 0mL, while for other donors it may be set to 250mL. It should be noted that 0 and 250mL are provided as examples only, and other embodiments may have target intravascular insufficiency of 0 to 250mL or greater than 250mL. In addition, in some cases, it may be beneficial to return more fluid to the donor than is withdrawn/collected. In this case, the target intravascular insufficiency may be set to less than zero (e.g., -1 to-250 mL) so that the donor has more fluid/volume after the procedure than before the procedure.

Like the method 400 shown in fig. 4, the method 500 may similarly perform some additional and optional steps to help determine the volume of pure plasma within the plasma collection container 216. For example, certain embodiments may monitor a change in weight of anticoagulant container 210 (e.g., as measured by a weight sensor/load sensor on anticoagulant container 210) (step 550). This measurement provides an indication of the volume of anticoagulant that has been added to the system 100 and can be used to help determine the percentage of anticoagulant within the plasma collection container 216. Additionally or alternatively, some embodiments may similarly monitor the change in weight and/or volume of plasma and anticoagulant collected within plasma collection container 216 (e.g., via weight sensor 195) (step 555). This measurement may be used to calculate the total volume of pure plasma collected within plasma collection container 216 (e.g., to obtain the total weight from which to subtract the calculated anticoagulant volume). In addition, some embodiments may also use an optical sensor on the drum 214 to monitor the volume of anticoagulant remaining in the drum 214 (step 565) (e.g., anticoagulant that is not mixed with and/or otherwise remains in the drum) to determine if any anticoagulant remains within the drum 214 and to modify the calculation of the amount of pure plasma collected in the plasma collection container based on the volume of anticoagulant remaining within the drum 214 (e.g., increase the calculated amount or decrease the calculated amount).

As described above, prior art systems following the current FDA nomogram for plasma collection collect a volume of plasma product based only on the weight of the donor (e.g., anticoagulant and plasma are mixed together) -collect the same volume from each donor of the same weight. However, the total blood volume and plasma volume of the two donors may vary greatly. For example, when two donors (one obese and one non-obese) in the same somatic recombination are compared according to the FDA nomogram, an obese donor will actually have a lower blood volume than a non-obese donor. Furthermore, a donor with a high hematocrit will have a lower plasma volume relative to the total plasma volume. In other words, since the total blood volume and total plasma volume vary from donor to donor (even between donors of the same weight), the percentage of plasma of the final collected donor may vary greatly from donor to donor. By tailoring plasma collection to the donor (e.g., based on the height, weight, BMI, hematocrit, total blood volume, and/or total plasma volume of the donor) and collecting a predetermined percentage of plasma from each donor, embodiments of the present invention are able to collect a greater volume of plasma (e.g., pure plasma) from some donors and a lesser volume of plasma from weaker donors (e.g., donors with high hematocrit, donors with lower plasma volumes, etc.) than systems that do not establish collection volumes based on individual donors.

Similarly, current systems do not tailor the saline return volume to the patient (e.g., each donor at a given level receives the same volume of saline, e.g., if the target plasma product volume is 800mL, the donor will receive 500mL saline). However, because prior art systems collect based on the volume of plasma product (including both plasma and anticoagulant) and the volume of pure plasma actually collected (and thus the volume removed from the donor) varies based on the hematocrit of the donor, the intravascular insufficiency of each donor will be different. In other words, the volume of saline returned to the donor may be sufficient for some donors, but may be insufficient for other donors. By tailoring the saline returned to the individual donors, embodiments of the present invention can ensure that once the procedure is completed, each donor has the same intravascular insufficiency (if any). This in turn allows embodiments of the present invention to achieve isovolemia for each donor and greatly reduces any adverse reactions (e.g., falls, syncopes, dizziness, vasovagal reactions, etc.) that the donor may experience.

It is also important to note that while the various embodiments discussed above are related to a blood processing system that collects plasma, the features discussed herein may be applied to any type of blood processing system. For example, the features described herein may be implemented on a blood processing system that collects and/or processes red blood cells, platelets, and/or white blood cells.

The embodiments of the invention described above are exemplary only; many variations and modifications will be apparent to practitioners skilled in the art. All such variations and modifications are intended to be within the scope of the present invention as defined in any appended claims.

Claims

1. A method for collecting plasma, comprising:

(a) Determining the weight and height of the donor;

(b) Determining the hematocrit of the donor;

(c) Calculating a total plasma volume of the donor based at least in part on the weight and height of the donor and the hematocrit of the donor;

(d) Calculating a target plasma collection volume based at least in part on the calculated total plasma volume of the donor and the target percentage of plasma;

(e) Introducing an anticoagulant into whole blood drawn from a donor through an venous-access device and a first line through an anticoagulant line, wherein the first line is connected to a blood component separation device;

(f) Separating the drawn whole blood into a plasma component and at least a second blood component using a blood component separation device;

(g) Collecting plasma components from the blood component separation device into a plasma collection container;

(h) Calculating the volume of pure plasma collected in the plasma collection container; and

(i) Steps (e) through (h) are continuously performed until the calculated amount of pure plasma collected in the plasma collection container is equal to the target plasma collection amount.

2. The method of claim 1, further comprising:

the intravascular deficiency is calculated based at least in part on the volume of the collected pure plasma and the volume of the contents of the blood component separation device returned to the donor.

3. The method of claim 2, further comprising:

the target intravascular insufficiency is obtained based on the volume of saline returned to the donor.

4. The method of claim 3, wherein the target intravascular deficiency is 0 milliliters.

5. The method of claim 3, wherein the target intravascular deficiency is-250 to 500 milliliters.

6. The method of claim 1, further comprising:

the body mass index of the donor is calculated based at least in part on the weight and height of the donor, and the total plasma volume of the donor is calculated based at least in part on the body mass index of the donor.

7. The method of claim 1, wherein the target percentage of plasma is 26.5% to 29.5% of the total plasma volume of the donor.

8. The method of claim 1, further comprising:

calculating a volume of anticoagulant in the collected plasma constituent based at least in part on the hematocrit of the donor, and calculating a volume of pure plasma based at least in part on the calculated volume of anticoagulant in the collected plasma constituent.

9. The method of claim 8, further comprising:

a change in volume in the anticoagulant container is determined, and the calculated volume of anticoagulant in the collected plasma is based at least in part on the change in volume in the anticoagulant container.

10. The method of claim 8, further comprising:

the volume of anticoagulant introduced into the whole blood is determined based on the number of revolutions of the anticoagulant pump, and the calculated volume of anticoagulant in the collected plasma is based at least in part on the number of revolutions of the anticoagulant pump.

11. The method of claim 8, further comprising:

determining a volume of anticoagulant in the blood component separation device, the calculated volume of anticoagulant in the collected plasma based at least in part on the volume of anticoagulant in the blood component separation device.

12. The method of claim 8, wherein the volume of anticoagulant in the collected plasma components includes at least a portion of the anticoagulant introduced into the drawn blood and at least a portion of the volume of anticoagulant added during the filling step.

13. The method of claim 1, further comprising:

the volume of the collected plasma component in the plasma collection container is monitored, and the calculated volume of the pure plasma collected in the plasma collection device is based at least in part on the monitored volume of the collected plasma component.

14. The method of claim 1, further comprising:

the weight of the collected plasma component in the plasma collection container is monitored, and the calculated volume of pure plasma collected in the plasma collection device is based at least in part on the monitored weight of the collected plasma component.

15. The method of claim 1, wherein step (b) comprises monitoring a volume of red blood cells collected in the blood separation device, the determined hematocrit of the donor being based at least in part on the monitored volume of red blood cells collected in the blood separation device and a volume of whole blood drawn from the donor.

16. A system for collecting plasma, comprising:

venous access device for drawing whole blood from a subject and returning blood components to the subject;

a blood component separation device for separating the drawn blood into a plasma component and a second blood component, the blood component separation device having an outlet and configured to deliver the plasma component to a plasma container;

a first line fluidly connected to the venous-access device and configured to deliver drawn whole blood to the blood component separation device and return fluid in the blood component separation device to the subject, a flow rate through the first line being controlled by a first pump;

An anticoagulant line connected to an anticoagulant source, the anticoagulant line configured to introduce an anticoagulant into the drawn whole blood; and

a controller configured to control operation of the centrifugal bowl and the first pump, the controller configured to: (1) calculating a total plasma volume of the donor based at least in part on the weight and height of the donor and the hematocrit of the donor, (2) calculating a target plasma collection volume based at least in part on the calculated total plasma volume of the donor and the target percentage of plasma, and (3) calculating a volume of pure plasma collected in the plasma container based at least in part on the volume of anticoagulant in the collected plasma component, the controller configured to stop the first pump when the calculated volume of pure plasma collected in the plasma collection container is equal to the target plasma collection volume.

17. The system of claim 16, wherein the controller is further configured to:

after collecting at least a portion of the target plasma collection volume, the fluid remaining in the blood component separation device is returned through the first line.

18. The system of claim 17, wherein the controller is further configured to:

19. The system of claim 18, further comprising:

a saline line configured to be fluidly connected to a saline source and a blood component separation device, the controller configured to return a volume of saline to the donor to obtain a target intravascular deficiency.

20. The system of claim 19, wherein the target intravascular deficiency is-250 to 500 milliliters.

21. The system of claim 16, wherein the controller is further configured to:

22. The system of claim 16, wherein the target percentage of plasma is 26.5% to 29.5% of the total plasma volume of the donor.

23. The system of claim 16, wherein the controller is further configured to:

the volume of anticoagulant in the collected plasma component is calculated based at least in part on the hematocrit of the donor.

24. The system of claim 23, wherein the volume of anticoagulant in the collected plasma component is based at least in part on the volume of anticoagulant added to the drawn whole blood and the hematocrit of the subject.

25. The system of claim 23, further comprising:

an anticoagulant source weight sensor configured to measure a weight of the anticoagulant source, the controller further configured to monitor a change in volume in the anticoagulant container based on the measured weight of the anticoagulant source, the calculated volume of anticoagulant in the collected plasma based at least in part on the change in volume in the anticoagulant source.

26. The system of claim 23, wherein the controller is configured to monitor a number of revolutions of the anticoagulant pump to determine a volume of anticoagulant introduced into the whole blood, the calculated volume of anticoagulant in the collected plasma based at least in part on the number of revolutions of the anticoagulant pump.

27. The system of claim 23, further comprising:

an optical sensor located on the blood component separation device and configured to monitor the contents of the blood component separation device and determine whether a volume of anticoagulant remains in the blood component separation device, the calculated volume of anticoagulant in the collected plasma based at least in part on the volume of anticoagulant in the blood component separation device.

28. The system of claim 16, further comprising:

a plasma container weight sensor configured to monitor a volume of collected plasma components in the plasma container, the calculated volume of pure plasma collected in the plasma collection device based at least in part on the monitored volume of collected plasma components.

29. The system of claim 16, further comprising:

a plasma container weight sensor configured to monitor the weight of the collected plasma component in the plasma container, the calculated volume of pure plasma collected in the plasma collection device based at least in part on the monitored weight of the collected plasma component.

30. The system of claim 16, further comprising:

an optical sensor located on the blood component separation device configured to monitor a volume of red blood cells collected in the blood separation device, the controller configured to determine a hematocrit of the subject based at least in part on the monitored volume of red blood cells collected in the blood separation device and a volume of whole blood drawn from the donor.

31. A method for collecting plasma, comprising:

(a) Determining the weight and height of the donor;

(b) Determining the hematocrit of the donor;

(f) Separating the drawn whole blood into a plasma component and at least a second blood component;

(h) Continuing to perform steps (e) through (g) until a target plasma collection volume is reached in the plasma collection container.

32. The method of claim 31, further comprising:

the method includes calculating a volume of anticoagulant to be collected with a plasma constituent in a plasma collection container, the volume of anticoagulant to be collected with the plasma constituent based at least in part on a hematocrit of a donor.

33. The method of claim 32, wherein the target plasma collection volume is the target pure plasma collection volume plus the calculated volume of anticoagulant to be collected.

34. The method of claim 32, wherein the target plasma collection volume is a target pure plasma collection volume in a plasma collection container, the target pure plasma collection volume based at least in part on a volume of anticoagulant to be collected with the plasma component in the plasma collection container.

35. The method of claim 31, further comprising:

36. The method of claim 31, wherein the target percentage of plasma is 26.5% to 29.5% of the total plasma volume of the donor.

37. A system for collecting plasma, comprising:

venous access means for withdrawing whole blood from the donor and returning blood components to the donor;

a blood component separation device for separating the drawn blood into a plasma component and a second blood component, the blood component separation device having an outlet and configured to deliver the plasma component to a plasma collection container;

a first line fluidly connected to the venous-access device and configured to deliver drawn whole blood to the blood component separation device and return fluid in the blood component separation device to the donor, a flow rate through the first line being controlled by a first pump;

a controller configured to control operation of the blood component separation device and the first pump, the controller configured to: (1) calculating a total plasma volume of the donor based at least in part on the weight and height of the donor and the hematocrit of the donor, (2) calculating a target plasma collection volume based at least in part on the calculated total plasma volume of the donor and the target percentage of plasma, and (3) calculating a volume of plasma constituent collected in the plasma collection container, the controller configured to stop the first pump when the calculated volume of plasma constituent collected in the plasma collection container is equal to the target plasma collection volume.

38. The system of claim 37, wherein the controller is further configured to calculate a volume of anticoagulant to be collected with the plasma constituent in the plasma collection container, the volume of anticoagulant to be collected with the plasma constituent based at least in part on a hematocrit of the donor.

39. The system of claim 38, wherein the target plasma collection volume is a target pure plasma collection volume plus the calculated volume of anticoagulant to be collected.

40. The system of claim 38, wherein the target plasma collection volume is a target pure plasma collection volume in the plasma collection container, the target pure plasma collection volume based at least in part on a volume of anticoagulant to be collected in the plasma collection container with the plasma component, the controller configured to stop the first pump when the calculated volume of pure plasma collected in the plasma collection container is equal to the target plasma collection volume.

41. The system of claim 37, wherein the controller is further configured to calculate a body mass index of the donor based at least in part on the weight and height of the donor, and to calculate a total plasma volume of the donor based at least in part on the body mass index of the donor.

42. The system of claim 37, wherein the target plasma collection volume is calculated prior to drawing whole blood.

43. The system of claim 37, wherein the target percentage of plasma is 26.5% to 29.5% of the total plasma volume of the donor.

44. A method for programming a blood processing apparatus, comprising:

(a) Receiving in a control system the weight and height of the donor;

(b) Receiving a hematocrit of a donor in a control system;

(c) Calculating a total plasma volume of the donor using a control system, the control system calculating the total plasma volume of the donor based at least in part on the weight and height of the donor and the hematocrit of the donor;

(d) Calculating a target plasma collection volume using a control system, the control system calculating the target plasma collection volume based at least in part on the calculated total plasma volume of the donor and the target percentage of plasma;

(e) Determining a target collection volume based at least in part on the calculated target plasma collection volume; and

(f) The controller of the blood processing apparatus is programmed with a blood processing endpoint that is based at least in part on the target collection volume.

45. The method of claim 44, further comprising:

The volume of anticoagulant to be collected with the plasma component in the plasma collection container is calculated using a control system that calculates the volume of anticoagulant to be collected with the plasma component based at least in part on the hematocrit of the donor.

46. The method of claim 45, wherein the target plasma collection volume is a target pure plasma collection volume based at least in part on a volume of anticoagulant to be collected with the plasma component.

47. The method of claim 46, wherein the target collection volume is a target pure plasma collection volume.

48. The method of claim 46, wherein the target plasma collection volume is the target pure plasma collection volume plus the calculated volume of anticoagulant to be collected in the plasma collection container.

49. The method of claim 44, further comprising:

the body mass index of the donor is calculated based at least in part on the weight and height of the donor using a control system that calculates a total plasma volume of the donor based at least in part on the body mass index of the donor.

50. The method of claim 44, wherein the blood processing endpoint is when a target collection volume is collected in a plasma collection container of the blood processing apparatus.

51. The method of claim 44, wherein the control system comprises a controller.

52. A system for collecting plasma, comprising:

a blood processing apparatus comprising:

a blood withdrawal line fluidly connected to the venous-access device and configured to deliver withdrawn whole blood to the blood component separation device, the flow rate through the blood withdrawal line being controlled by a blood withdrawal pump;

a controller configured to: (1) calculating a total plasma volume of the donor based at least in part on the weight and height of the donor and the hematocrit of the donor, (2) calculating a target plasma collection volume based at least in part on the calculated total plasma volume of the donor and the target percentage of plasma, and (3) calculating the target collection volume based at least in part on the calculated target plasma collection volume.

53. The system of claim 52, wherein the blood processing device is configured to stop the blood pump when a target collection volume is collected in the plasma collection container.

54. The system of claim 52, wherein the controller is part of a blood processing device.

55. The system of claim 52, wherein the controller is further configured to program the blood processing device with a blood processing endpoint based at least in part on the target collection volume.

56. The system of claim 55, wherein the blood processing endpoint is when a target collection volume is collected in the plasma collection container.

57. The system of claim 52, wherein the target plasma collection volume is a target pure plasma collection volume in the plasma collection container, the target pure plasma collection volume based at least in part on a volume of anticoagulant to be collected with the plasma component in the plasma collection container.

58. The system of claim 57, wherein the target collection volume is a target pure plasma collection volume and/or a target pure plasma collection volume in the plasma collection container plus a volume of anticoagulant to be collected.

59. The system of claim 52, wherein the controller is further configured to calculate a body mass index of the donor based at least in part on the weight and height of the donor, and calculate a total plasma volume of the donor based at least in part on the body mass index of the donor.