KR20240017096A - System and operating method for collecting plasma - Google Patents

Abstract

A method for collecting plasma includes determining the donor's weight, height, and hematocrit, and calculating the donor plasma volume and target plasma collection volume. Target plasma collection volume is based on donor plasma volume and target plasma percentage. The method then withdraws blood from the donor through a line connected to a blood component separation device and introduces an anticoagulant into the withdrawn blood.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 into a plasma collection container. The method may then calculate the volume of pure plasma collected within the plasma collection container and continue processing/collection until the calculated volume of pure plasma is equal to the target plasma collection volume.

Description

System and method for collecting plasma {SYSTEM AND OPERATING METHOD FOR COLLECTING PLASMA}

preference

This patent application is “System and Method for Collecting Plasma,” filed October 25, 2017, with Agent Docket No. 130670-08003 (formerly 1611/C86) and the inventor’s name is Michael Ragusa. Priority is claimed on U.S. Patent Application No. 15/793,339, the disclosure of which is hereby incorporated by reference in its entirety.

U.S. Patent Application No. 15/793,339, in turn, is “System and Method for Collecting,” filed May 30, 2017, with Agent Docket No. 130670-08002 (formerly 1611/C80) and inventor name Ragusa Michael. It is a continuation-in-part and claims priority of U.S. Patent Application No. 15/608,183, entitled “Plasma,” the disclosure of which is incorporated herein by reference in its entirety.

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

Apheresis is a procedure by which individual blood components can be separated and collected from whole blood temporarily withdrawn from a subject. Typically, whole blood is drawn into a cell separator, such as a centrifuge vessel, through a needle inserted into a vein in the subject's arm. Once whole blood has been separated into its various components, one or more of the components (eg, plasma) can be removed from the centrifuge vessel. The remaining components may be returned to the subject with optional compensating fluid to preserve the volume of components removed. The aspiration and return process continues until a certain amount of the desired ingredient is collected, at which point the process is stopped. The main feature of the apheresis system is that processed but unwanted components are returned to the donor. 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 lower 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 mL for adults weighing more than 175 pounds) as well as an upper limit on the total collection volume (e.g., 800 mL for adults weighing more than 175 pounds). For adults exceeding 880 ml), both are set. Prior art plasma collection systems are unable to determine the total volume of plasma collected (e.g., because the collected product is a mixture of plasma and anticoagulant) and, therefore, if the total volume of plasma collected is below the limits prescribed by the FDA. Even so, collection is based on the total collection volume. Additionally, prior art collection systems do not tailor the amount of plasma collected to the individual (e.g., other than what weight group the individual falls into) and, therefore, the percentage of a patient's plasma collected can vary widely from patient to patient. varies widely (e.g., for some patients only 23% of plasma is collected, for others 29% - or more).

[Prior art literature]

Patent Document 1: US 2001/0000185 A1 (2001.04.05.)

According to some embodiments of the invention, a method for collecting plasma includes determining the 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 can withdraw whole blood from the donor through an aspiration line connected to the venous access device and a blood component separation device. The method may then introduce an anticoagulant into the drawn whole blood through an anticoagulant line, and use a blood component separation device to separate the drawn whole blood into a plasma component and at least a second blood component. Once separated, the plasma components can be collected from the blood component separation device into a plasma collection container. During processing, the method can calculate (1) the percentage of anticoagulant in the collected plasma components, and (2) the volume of pure plasma collected within the plasma collection container. The volume of pure plasma may be based at least in part on the calculated percentage of anticoagulant in the collected plasma components. The method involves the following steps (e.g., withdrawing whole blood, introducing an anticoagulant into the whole blood, separating the blood, collecting plasma, and dissolving the anticoagulant) until a target volume of pure plasma is collected in the plasma collection vessel. (calculating the percentage and volume of pure plasma) can be continued.

In some embodiments, the method may determine a change in volume within the anticoagulant vessel, 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 vessel. 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 the volume of anticoagulant within 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 within the blood component separation device.

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

The target volume of pure plasma may be based at least in part on the donor's body weight. 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 via a return line.

According to additional embodiments, a system for collecting plasma includes a venous access device for aspirating whole blood from a subject and returning the blood components to the subject, and for separating the aspirated blood into a plasma component and a second blood component. Includes a blood component separation device. The blood component separation device has an outlet and is configured to direct the plasma components to the plasma container. The system may also include a blood aspiration line fluidly connected to a venous access device and an anticoagulant line connected to an anticoagulant source. The blood aspiration line transports the aspirated whole blood to the blood component separation device, and the flow through the blood aspiration line can be controlled by a blood aspiration pump. The anticoagulant line can introduce an anticoagulant into the aspirated whole blood.

Additionally, the system may include a controller that controls the operation of the centrifuge vessel. The controller may also calculate (1) the percentage of anticoagulant in the collected plasma components, and (2) the volume of pure plasma collected within 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 aspiration pump when a target volume of pure plasma (eg, based at least in part on the donor's body weight) has been collected in the plasma vessel. In some embodiments, the percentage of anticoagulant in the collected plasma components may be based at least in part on the subject's hematocrit and the volume of anticoagulant added to the aspirated whole blood.

The system may also include an anticoagulant source weight sensor that measures the weight of the anticoagulant source. The controller may monitor changes in volume within the anticoagulant vessel 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 positioned 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 within 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 within the blood component separation device.

In additional embodiments, the system may also include a plasma vessel weight sensor that monitors the volume and/or weight of plasma components collected within the plasma collection vessel. The calculated volume of pure plasma collected within the plasma collection vessel 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 positioned on the blood component separation device. An optical sensor can monitor the volume of red blood cells collected within the blood separation device. The controller may then determine the subject's hematocrit based at least in part on the monitored volume of red blood cells collected within the blood separation device and the volume of whole blood withdrawn 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 to the system during the priming step.

According to additional embodiments, a method for collecting plasma includes determining a donor's weight, height, and hematocrit and calculating a donor plasma volume based at least in part on the donor's weight, height, and hematocrit. . The method then calculates a target plasma collection volume based at least in part on the calculated donor plasma volume and the target plasma percentage (e.g., 26.5 to 29.5 percent of the donor's plasma volume), the venous access device, and the blood component separation device. Whole blood is withdrawn from the donor through a first line connected to . As whole blood is withdrawn, the method may introduce an anticoagulant into the withdrawn whole blood, via an anticoagulant line.

The blood component separation device may separate the drawn whole blood into a plasma component and at least a second blood component, and the method may collect the plasma component from the blood component separation device into a plasma collection container. During processing, the method may calculate the volume of pure plasma collected within the plasma collection vessel. The method continues the steps of withdrawal, introduction of anticoagulant, separation, collection, and calculation until the volume of pure plasma collected within the plasma collection vessel 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 via a first line. Additionally or alternatively, the method may calculate intravascular deficit based at least in part on the volume of pure plasma collected and 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 achieve the target intravascular depletion. The target intravascular deficit may be -250 to 500 milliliters (eg, 0 milliliters or 250 milliliters). The donor plasma volume can be calculated based at least in part on the donor's body mass index, which in turn is calculated based on the donor's weight and height.

In additional embodiments, the method may include calculating the percentage of anticoagulant in the collected plasma components. 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 the change in volume within the anticoagulant container, the number of revolutions of the anticoagulant pump, and/or the volume of anticoagulant within the blood component separation device. The method may determine a change in volume within an anticoagulant container, a volume of anticoagulant introduced into whole blood, and/or a volume of anticoagulant within a blood component separation device. 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 priming step.

In some embodiments, the method may include monitoring the volume and/or weight of plasma components collected within the plasma collection vessel. In such embodiments, the calculated volume of pure plasma collected within the plasma collection device may be based at least in part on the monitored volume and/or weight of the collected plasma components. To determine a donor's hematocrit, the method may monitor the volume of red blood cells collected within the blood separation device. A donor's hematocrit may be based at least in part on the monitored volume of red blood cells collected within the blood separation device and the volume of whole blood withdrawn from the donor.

According to still further embodiments, a system for collecting plasma includes a venous access device for aspirating whole blood from a subject and returning the blood components to the subject, and for separating the aspirated blood into a plasma component and a second blood component. Includes a blood component separation device. The blood component separation device may have an outlet and may direct plasma components to a plasma vessel. 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) transport aspirated whole blood to the blood component separation device and (2) return fluid within the blood component separation device to the subject. Flow through the first line may be controlled by a first pump. The anticoagulant line can be connected to an anticoagulant source and introduce anticoagulant into the aspirated whole blood.

The system may also include a controller that controls the operation of the centrifuge vessel and the first pump. The controller may calculate (1) the donor plasma volume, (2) the target plasma collection volume, and (3) the volume of pure plasma collected within the plasma vessel. The donor plasma volume may be based at least in part on the donor's weight and height, and the donor's hematocrit. The target plasma collection volume may be based at least in part on the calculated donor plasma volume and target plasma percentage. The volume of pure plasma collected within the plasma vessel 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 within the plasma collection vessel is equal to the target plasma collection volume.

In additional embodiments, the controller may return fluid remaining within 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 deficit based at least in part on the volume of pure plasma collected and the contents of the blood component separation device returned to the donor. The system may also include a saline line fluidly connected to a saline source and a blood component separation device. The controller may return a volume of saline to the donor to achieve the target intravascular deficit (eg, -250 to 500 milliliters).

The controller may calculate the donor's body mass index based at least in part on the donor's weight and height. In turn, the donor plasma volume can be calculated based at least in part on the donor's body mass index. The target plasma percentage may be 26.5 to 29.5 percent (eg, 28.5 percent) of the donor's plasma volume.

In additional embodiments, the controller may calculate the percentage of anticoagulant in the collected plasma components based, for example, on the volume of anticoagulant added to aspirated whole blood and the subject's hematocrit. The system may also include an anticoagulant source weight sensor that measures the weight of the anticoagulant source. The controller can then monitor changes in volume within the anticoagulant vessel 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 changes 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 also include optical sensors and/or plasma vessel weight sensors. An optical sensor may be positioned on the blood component separation device and may monitor the contents of the blood component separation device to determine whether a volume of anticoagulant remains within the blood component separation device. The calculated percentage of anticoagulant in the collected plasma can then be based at least in part on the volume of anticoagulant within the blood component separation device. A plasma vessel weight sensor can monitor the volume and/or weight of plasma components collected within a plasma vessel. The calculated volume of pure plasma collected within the plasma collection device may then be based at least in part on the monitored volume and/or weight of the collected plasma components. The optical sensor may also monitor the volume of red blood cells collected within the blood separation device, and the controller may determine the volume of red blood cells collected within the blood separation device based at least in part on the monitored volume of red blood cells collected within the blood separation device and the volume of whole blood withdrawn from the donor. The hematocrit can be determined. 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 priming step.

The foregoing features of the present invention will be more readily understood by reference to the following detailed description taken with reference to the accompanying drawings.
1 schematically shows a perspective view of a blood processing system according to some embodiments of the invention.
Figure 2 schematically shows a top view of the blood processing system of Figure 1, according to some embodiments of the invention.
Figure 3 schematically shows a disposable set installed within the blood processing system of Figure 1, according to some embodiments of the invention.
Figure 4 is a flow diagram illustrating a method for collecting plasma, according to embodiments of the present invention.
Figure 5 is a flow diagram illustrating an alternative method of collecting plasma, according to additional embodiments of the present invention.

Exemplary embodiments of the present invention provide blood processing systems and methods for collecting a target volume of pure plasma. Systems and methods calculate the percentage of anticoagulant collected within a plasma collection vessel (e.g., added to plasma collected within the vessel) based on the amount of anticoagulant added to the system and the donor's hematocrit. The system/method can then calculate the volume of pure plasma (e.g., plasma without anticoagulant) collected within the container. Additional embodiments may tailor the volume of plasma collected based on the donor's plasma volume and a target percentage of plasma to be collected. Details of example embodiments are discussed below.

As shown in FIGS. 1 and 2 , blood processing system 100 includes a cabinet 110 that houses major components (eg, non-disposable components) of system 100 . Within cabinet 110, system 100 includes a first/blood pump 232 to aspirate whole blood from a subject, and a second/anticoagulant pump (232) to pump an anticoagulant into the aspirated whole blood through system 100. 234) may be included. Additionally, system 100 may include a number of valves that can be opened and/or closed to control fluid flow through system 100. For example, system 100 includes a donor valve 120 that can be opened and closed to selectively prevent and allow fluid flow through a donor line 218 (e.g., an inlet line; FIG. 3), and an outlet/plasma line. It may include a plasma valve 130 that selectively prevents and allows fluid flow through 222 (FIG. 3). Some embodiments may also include a saline valve 135 that selectively prevents and allows saline water to flow through saline line 223.

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

As discussed in more detail below, apheresis system 100 according to embodiments of the present invention uses blood pump 232 to withdraw whole blood from a subject via venous access device 206 (FIG. 3). do. As system 100 withdraws whole blood from a subject, the whole blood enters a blood component separation device 214, such as a Latham type centrifuge (integral as described in U.S. Pat. Nos. 4,983,158 and 4,943,273). Other types of separation chambers and devices, such as blow molded centrifuge vessels, may be used without limitation, and these patents are incorporated herein by reference). The blood component separation device 214 separates whole blood into its components (eg, red blood cells, white blood cells, plasma, and platelets). Accordingly, to facilitate operation of the separation device 214, the system 100 may be configured such that the separation device 214 can be disposed (e.g., to generate the centrifugal forces required to separate whole blood). 214 may also include a rotating well 180.

To enable the user/technician to monitor system operation and control/set various parameters of the procedure, system 100 provides operating parameters, any alarm messages, and the buttons the user/technician can press to control the various parameters. It may include a user interface 190 (e.g., a touch screen device) that displays buttons that can be used. Additional components of blood processing system 100 are discussed in more detail below (eg, with respect to system operation).

3 illustrates a blood processing system 100 and a disposable collection set 200 (inlet disposable set 200A and outlet disposable set 200B) that can be loaded onto/in the blood processing system 100, in accordance with the present invention. This is a schematic block diagram of ). Collection set 200 includes a venous access device 206 (e.g., a phlebotomy needle) for withdrawing blood from the donor's arm 208, an anticoagulant vessel 210, and a centrifuge vessel 214 (e.g., separation of blood components). device), a saline container (217), and a final plasma collection bag (216). Blood/inflow line 218 couples venous access device 206 to inlet port 220 of vessel 214, and plasma/outlet line 222 connects outlet port 224 of vessel 214 to collect plasma. Coupled to the bag 216, a saline solution line 223 connects the discharge port 224 of the container 214 to the saline container 217. Anticoagulant line 225 connects anticoagulant container 210 to inlet line 218. In addition to the components mentioned above and shown in FIG. 3, blood processing system 100 includes a controller 226, motor 228, and centrifugal chuck 230. Controller 226 is operably coupled to two pumps 232 and 234 and a motor 228, which in turn drives chuck 230. Controller 226 may be operably coupled to and communicate with user interface 190.

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

4 is a flow chart depicting an exemplary method of collecting plasma, according to various embodiments of the present invention. Before connecting a donor to the blood processing device 100, it is beneficial (and perhaps in some cases (required). This information not only helps determine whether an individual is a viable donor and the volume of blood components that can be withdrawn/collected (e.g., according to FDA guidelines), but also helps determine whether the hematocrit can be used during processing to target plasma. It can be helpful in collecting volume. The technician may obtain/determine the donor's weight by weighing the donor (e.g., on a scale). To obtain/determine a donor's hematocrit, the technician may aspirate 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, blood processing device 100 may include a hematocrit sensor (not shown) that determines the hematocrit of blood flowing into blood processing device 100 and/or system 100 may include a hematocrit sensor (not shown) within vessel 214. Hematocrit can be determined based on the volume of collected red blood cells.

Once the lines 222/223 are in place and the technician has determined the donor's weight and/or hematocrit (if necessary), the user/technician inserts the venous access device 206 into the donor's arm 208. You can (step 420). Next, controller 226 activates two pumps 232 and 234 and motor 228. Operation of the two pumps 232, 234 causes whole blood to be aspirated from the donor (step 425), anticoagulant from container 210 to be introduced into the aspirated whole blood (step 430), and then anticoagulated Whole blood is delivered to the inlet port 220 of the vessel 214.

Anticoagulant line 225 also includes an anticoagulant source 210, an anticoagulant, or a bacterial filter (not shown) that prevents any bacteria from anticoagulant line 225 from entering system 100 and/or the subject. It should be noted that it can be done. Additionally, anticoagulant line 225 may include an air detector 140 that detects the presence of air in the anticoagulant. The presence of air bubbles within any of the lines of system 100 may be problematic for the operation of system 100 and may also be harmful to the subject if the bubbles enter the bloodstream. Accordingly, the air detector may be connected to an interlock that stops flow in the anticoagulant line 225 (e.g., by stopping the anticoagulant pump 234) if air bubbles are detected, thereby preventing air bubbles from entering the subject. is prevented.

As the anticoagulated whole blood is withdrawn from the subject and accommodated in the blood component separation device 214, the blood component separation device 214 separates the whole blood into various blood components (step 435). For example, 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 forces generated by the rotation of the separation device 214) separates whole blood into plasma, platelets, red blood cells (“RBCs”), and possibly white blood cells (“WBCs”). ) can be separated. The higher density components, i.e. RBCs, are forced to the outer walls of the vessel 214, while the lower density plasma lies closer to the center. A buffy coat is formed between the plasma and RBCs. The buffy coat is composed 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 port and the first fluid component pushed out of the vessel 214 through the outlet port 224 as additional anticoagulated whole blood enters the vessel 214 through the inlet port 220. am.

As shown in FIG. 3 , system 100 can also include an optical sensor 213 that can be applied to the shoulder portion of container 214 . Optical sensors monitor each layer of blood components as they progress gradually and coaxially from the outer wall of the vessel 214 toward the center. Optical sensor 213 may be mounted at a location (e.g., within well 180) that can detect the buffy coat and/or red blood cells reaching a certain radius, aspirate whole blood from a subject/donor and deposit it into a container ( The steps of introducing whole blood into 12) may be modified and/or terminated in response to detection.

Additionally, in some embodiments, optical sensor 213 may be used to determine a donor's hematocrit during processing. For example, as the vessel 214 is filled with red blood cells and the optical sensor 213 detects the layer of red blood cells, the system 100 (e.g., the controller) can determine the location of the red blood cell layer and the fixed/known vessel volume. Thus, the volume of red blood cells in the container 214 can be determined. System 100 can then calculate the donor hematocrit based on the volume of red blood cells in the container and the volume of whole blood processed up to that point.

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

In some embodiments, system 100 also includes a line sensor 185 (mentioned above) that can determine the type of fluid (e.g., plasma, platelets, red blood cells, etc.) exiting blood component separation device 214. ) may include. In particular, line sensor 185 consists of an LED that emits light through blood components leaving the container 214, and a light detector that receives the light after it has passed through the components. The amount of light received by the light detector is correlated to the density of the fluid passing through the line. For example, when plasma is exiting container 214, line sensor 185 may detect when the plasma exiting container 214 is clouded by platelets (e.g., fluid changes from plasma to platelets). System 100 then uses this information to stop removal of blood components from vessel 214, stop aspiration of whole blood from the subject, or, for example, close one valve and open the other. The flow can be redirected by opening the valve.

It is important to note that during processing, the osmolality of the red blood cells prevents anticoagulants introduced in the whole blood from entering/remaining with the red blood cells (e.g., within container 214). Rather, the anticoagulant is mixed with plasma components. Accordingly, the anticoagulant exits vessel 214 with the plasma and is collected within collection vessel 216 along with the plasma. In other words, the weight of the product measured by weight sensor 195 is the weight of the plasma as well as any anticoagulant mixed with the plasma, and the weight provided by weight sensor 195 is not the weight of pure plasma.

Additionally, whole blood contains a variable amount of plasma, as determined by the donor's hematocrit. Hematocrit for typical donors can vary from 38% to 54%, meaning that for 100 mL of whole blood, the volume of plasma can vary from 36 to 62 mL. Additionally, the amount of anticoagulant added to the drawn whole blood is fixed (i.e., does not depend on the donor's hematocrit), meaning that the percentage of anticoagulant in the collected plasma varies for donor hematocrits of 38% and 54%, respectively. This means that it can vary from 9.7% to 12.7%. Accordingly, not only does the volume measured by weight sensor 195 include the volume of anticoagulant, but the volume of anticoagulant may vary from donor to donor based on hematocrit.

As noted above, some embodiments of the invention allow a target volume of pure plasma (e.g., plasma alone, without any volume of anticoagulant mixed with the plasma contained in the target volume) to be placed within the plasma collection vessel 216. Continue blood processing/separation procedures until collection. To that end, some embodiments of the invention may calculate the volume of pure plasma within the plasma collection vessel 216. For example, a technician or system 100 (e.g., a controller) may, based on the amount of anticoagulant added/metered to the donor's whole blood and the donor's hematocrit, determine the amount of collected plasma (e.g., contained within the plasma collection vessel 216). The percentage of anticoagulant in the plasma can be calculated (step 455). The technician and/or system may calculate the percentage of anticoagulant according to the following equation, where AC is the amount of anticoagulant added to system 100. As noted above, because the osmolarity of red blood cells prevents the anticoagulant from mixing with the red blood cells, essentially all of the anticoagulant exits vessel 214 and is collected along with the plasma in plasma collection vessel 216.

The amount of anticoagulant added to system 100 can be determined in a number of ways. For example, system 100 may base the amount of anticoagulant on a predetermined ratio of anticoagulant per unit of anticoagulated whole blood (e.g., the value of “AC” in the equation above). In some embodiments, the value of “AC” may be the reciprocal of a predetermined ratio (e.g., if the ratio of anticoagulant to anticoagulated whole blood is 1:16, “AC” would be 16). Additionally or alternatively, technician/system 100 may monitor the volume of anticoagulant added to the system. In such embodiments, the technician/system may be configured to perform the measurement based on the number of revolutions of the anticoagulant pump (e.g., each revolution of the anticoagulant pump introduces a set volume of anticoagulant into system 100) and/or by a weight sensor. The volume of anticoagulant added to system 100 can be monitored based on changes in the weight of anticoagulant container 210 as described (discussed in more detail below).

Once technician/system 100 calculates the percentage of anticoagulant in plasma collection vessel 216, technician/system 100 can then use this information to calculate the volume of pure plasma in plasma collection vessel 216. There is (step 465). For example, technician/system 100 may determine the volume of anticoagulant in the vessel (based on the percentage of anticoagulant in vessel 216) and determine the volume of fluid in vessel 216 as measured by weight sensor 195. This volume can be subtracted from the total volume. System 100 is configured to collect a target volume of pure plasma (e.g., 800 mL for an adult donor weighing more than 175 pounds or other limits prescribed by the FDA or similar regulatory agency) within plasma collection vessel 216. Until then, the volume of pure plasma collected within vessel 216 may continue to be monitored and whole blood processing may continue (e.g., steps 425, 430, 435, 440, 455, 460, and 465 may continue) (step 470).

Once system 100 has collected the target volume of pure plasma in plasma collection vessel 216, system 100 may return the remaining components (e.g., those remaining in vessel 214) to the subject. There is (step 475). For example, when all plasma has been removed and container 214 is full of RBCs (and any other blood components not collected), controller 226 can stop aspiration of whole blood from the subject and withdraw blood from container 214. The direction of blood/first pump 232 is reversed to aspirate RBCs (and other components) directly back to the subject. Alternatively, if system 100 is so equipped, the system may return the components to the subject via a dedicated return line.

In addition to blood components that are not collected (e.g., components remaining in container 214), system 100 may also return saline solution to the patient/subject. Saline can be used as a compensatory fluid to conserve the volume of blood components (e.g., plasma) that have been removed and not collected and returned to the patient. For that purpose, during the return phase (e.g., step 475), the saline valve 135 is opened to allow saline water from the saline container 217 through the saline line 223 and into the container (via outlet 224). 214), where the saline solution can be returned to the patient/donor with or after the remaining blood components.

It should be noted that some embodiments may perform some additional, optional steps to help determine the volume of pure plasma within the plasma collection vessel 216. For example, as noted above, some embodiments may monitor changes in the weight 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 added to system 100 and can be used to help determine the percentage of anticoagulant in plasma collection vessel 216. Additionally or alternatively, some embodiments may similarly monitor changes in weight and/or volume (e.g., via weight sensor 195) of the plasma and anticoagulant collected within plasma collection vessel 216. There is (step 450). This measurement can be used to calculate the total volume of pure plasma collected within the plasma collection vessel 216 (e.g., to obtain a total weight from which to subtract the calculated volume of anticoagulant).

Some embodiments may also (optionally) monitor the volume of anticoagulant remaining in vessel 214 (e.g., anticoagulant that has not been mixed with plasma and/or otherwise remains in the vessel) (step 460). For example, system 100 may utilize an optical sensor on vessel 214 to determine whether any anticoagulant remains within vessel 214. If so, the method 400/system 100 may modify the calculation of the amount of pure plasma collected within the plasma collection vessel based on the volume of anticoagulant remaining within the vessel 214 (e.g., change the calculated amount to increases or decreases the calculated amount).

The various embodiments of the invention described above offer many advantages over prior art plasma collection systems. In particular, as noted above, prior art plasma apheresis devices terminate plasma collection based on the total volume of anticoagulated plasma (e.g., pure plasma plus added anticoagulant). This is the easiest method as it only requires the product collection vessel to be weighed, but the actual amount of product - pure plasma - depends on the donor's hematocrit. In other words, prior art systems will collect more plasma from low hematocrit donors than from high hematocrit donors due to variations in the percentage of anticoagulant in the product. Various embodiments of the present invention solve the problems of prior art systems by collecting a standard volume (e.g., target volume) of pure plasma from each donor. As mentioned above, embodiments of the present invention provide the donor's hematocrit and the amount of anticoagulant collected within the plasma collection vessel 216 (e.g., by counting pump revolutions and/or using scale/weight sensors, etc.). This is accomplished by using your knowledge of to determine the percentage of anticoagulant in the product. Additionally, by stopping the plasma collection process based on the volume of pure plasma collected, embodiments of the present invention collect larger volumes of plasma compared to prior art systems that stop based on the plasma/anticoagulant mixture. can do.

Figure 5 is a system depicted in Figures 1-3 (or An alternative method for collecting plasma is shown, using a similar system. In a manner similar to that described above for the method shown in FIG. 4 , prior to connecting the donor to the blood processing device 100, the system/method may obtain some information about the donor, namely, the donor's weight and height (step 505 ) and hematocrit (step 510) may be obtained/determined. For example, a technician can obtain/determine a donor's height by measuring the donor's weight and measuring the donor by weighing the donor (e.g., on a scale). A technician may test a blood sample to obtain/determine the donor's hematocrit (e.g., in a manner similar to that described above), or the system may use a hematocrit sensor and/or red blood cells collected within container 214. Based on their volume, the hematocrit can be determined during blood processing.

Using the donor's height and weight, and hematocrit, system 100/method 500 may calculate the donor's plasma volume (e.g., the volume of plasma in the donor's blood) (step 515). For example, system 100/method 500 may calculate the body mass index (“BMI”) of a donor/subject using the donor's height and weight (e.g., BMI = weight/height ² ), and then calculate The total blood volume in the donor/subject can be calculated using the calculated BMI (e.g., Lemmens et al. , Estimating Blood Volume in Obese and Morbidly Obese Patients , Obesity Surgery, 2006:16, 773-776). reference, the subject matter of which is incorporated herein by reference). Total blood volume can be calculated using the following equation:

In the equation above, InBV is the index blood volume (e.g., the donor's total blood volume), BMIp is the patient's BMI (e.g., kg/m ² ), and 22 is the BMI value for ideal body weight (IBW) (e.g., , also in kg/m ² ), and 70 is the total blood volume (in mL/kg) for a donor of ideal weight (BMI = 22 kg/m ² ). Once system 100 calculates the total blood volume within the donor/subject, system 100 (e.g., a controller) then determines the volume of plasma in the donor's blood, e.g., based on the donor's hematocrit. can be calculated (step 515).

As mentioned above, the example shown in Figure 5 bases the plasma volume to be collected on the individual donor. To that end, once system 100/method 500 has determined the donor's plasma volume, system 100/method 500 may then calculate a target volume of plasma to collect (step 520 ). For example, system 100/method 500 may multiply the total plasma volume in a patient by a target percentage of plasma to collect (e.g., if the total plasma volume is 2700 mL and the total plasma volume to collect If the target percentage to collect is 28.5%, the target plasma volume to collect is 769.5 mL). The target percentage of plasma to collect may be application and/or donor dependent and may be entered directly into system 100 (e.g., using user interface 190) or may be preset at the factory. In some embodiments, the target percentage may be 26.5 to 30%, and preferably 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 can insert the venous access device 206 into the donor's arm 208. (step 525). Next, in a manner similar to that described above for the method shown in Figure 4, controller 226 activates the two pumps 232, 234 and motor 228. Operation of the two pumps 232, 234 causes whole blood to be aspirated from the donor (step 530), anticoagulant from container 210 to be introduced into the aspirated whole blood (step 535), and then anticoagulated Whole blood is delivered to the inlet port 220 of the vessel 214.

As 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., plasma, platelets, RBCs, and possibly into WBC) (step 540). As discussed above, the higher density component, i.e., RBCs, is forced to the outer wall of vessel 214, plasma is the component closest to the outlet port, and therefore additional anticoagulated whole blood is forced to the inlet port ( It is the first fluid component that is pushed out of the container 214 through the discharge port 224 when it enters the container 214 through 220. During separation and processing, the optical sensor 213 monitors each layer of blood components as it progresses gradually and coaxially from the outer wall of the container 214 towards the center and, in response to detection, detects the subject/ The steps of aspirating whole blood from a donor and introducing the whole blood into container 12 may be modified and/or terminated. Additionally, as discussed above, optical sensor 213 may be used to determine a donor's hematocrit during processing (e.g., when the hematocrit is not known and/or determined prior to the start of processing).

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

As mentioned above, some embodiments of the invention continue the blood processing/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 vessel 216, the target plasma collection volume is comprised of only pure plasma (e.g., the volume of any anticoagulant mixed with the plasma contained in the target volume). (without blood, only plasma). For that purpose, and in a manner similar to that described above, some embodiments of the invention may calculate the volume of pure plasma within the plasma collection vessel 216. To determine the volume of pure plasma, a technician or system 100 (e.g., a controller) determines the volume of collected plasma (e.g., plasma collection) based on the amount of anticoagulant added/metered to the donor's whole blood and the donor's hematocrit. The percentage of anticoagulant in the plasma contained within vessel 216 may be calculated (see equations provided above) (step 560). The amount of anticoagulant added to system 100 can be adjusted in any of the ways mentioned above (e.g., based on a predetermined ratio of anticoagulant per unit of anticoagulated whole blood, by monitoring the volume of anticoagulant added to the system, etc.). It can be determined in any way.

Once technician/system 100 calculates the percentage of anticoagulant in plasma collection vessel 216, technician/system 100 can then use this information to calculate the volume of pure plasma within plasma collection vessel 216. There is (step 570). For example, as discussed above, technician/system 100 may determine the volume of anticoagulant in the vessel (based on the percentage of anticoagulant in vessel 216) and the vessel as measured by weight sensor 195. This volume can be subtracted from the total volume of fluid within (216). System 100 continues until the volume of pure plasma collected within plasma collection vessel 216 reaches a target plasma volume (e.g., as calculated based on the donor's individual plasma volume and the target plasma percentage to be collected). , the volume of pure plasma collected within vessel 216 may be continuously monitored and whole blood processing may continue (e.g., steps 530, 535, 540, 545, 560, 570 and possibly steps 550, 555, and 565). Continue with (step 575).

Once system 100 has collected the target plasma volume within plasma collection vessel 216, system 100 stops withdrawing whole blood from the subject and from vessel 214 (e.g., blood/inflow line 218). By reversing the direction of the blood/first pump 232 to aspirate the RBCs (and other components) back to the subject (either directly, or via a dedicated return line, if so provided), the remaining components (e.g. , the ingredients remaining in the container 214) can be returned to the subject (step 580).

It is important to note that because system 100/method 500 collects and does not return some of the blood components (e.g., plasma), the volume of fluid returned to the donor/subject is less than the volume removed. This, in turn, creates an intravascular deficit 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 cases where the intravascular deficit is too large, there is a risk that the donor will faint when the procedure is completed and the donor gets up to leave the facility. To reduce intravascular depletion (and risk of injury to the donor), as noted above, some embodiments of the invention return saline to the patient/subject (step 585). Saline can be used as a compensatory fluid to preserve the volume of blood components (eg, plasma) removed. For that purpose, during the return phase (e.g., step 580), the controller 226 (or technician) opens the saline valve to allow saline from saline container 217 to flow through saline line 223 (outlet ( 224) into the container 214, where the saline solution can be returned to the patient/donor with or after the remaining blood components.

As mentioned above, the volume of plasma collected from a donor varies from donor to donor (e.g., because the volume is based on the donor's height, weight, hematocrit, and blood volume). Accordingly, the volume of saline returned to the donor to reduce intravascular deficits may similarly depend on the donor. To that end, when returning the contents of the separation device and saline solution to the donor (steps 580 and 585), the system 100/method 500 determines the total volume of whole blood removed from the donor and the blood components returned. The intravascular deficit may be calculated based on the volume of plasma and saline solution (or the volume of collected plasma and the volume of returned blood components and saline solution) (step 590). The system 100/method 500 may continue returning saline until the donor's intravascular depletion reaches the target intravascular depletion (step 595).

The target intravascular depletion may be any intravascular depletion that reduces the donor's risk of fainting and may be the same for each donor. For example, the target intravascular deficit can be set at 0 mL or 250 mL for each donor. Alternatively, the target intravascular deficit may be different for each donor, as may the target plasma volume to be collected. In other words, the target intravascular deficit may be set at 0 mL for some donors and 250 mL for others. It should be noted that 0 and 250 mL are provided as examples only, and other embodiments may have target intravascular deficits between 0 and 250, or greater than 250 mL. Additionally, in some cases, it may be beneficial to return more fluid to the donor than was removed/collected. In such cases, the target intravascular deficit can be set to less than zero (e.g., -1 to -250 mL) so that the donor has more fluid/volume after the procedure than he had before the procedure.

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

As noted above, prior art systems that follow the current FDA nomogram for plasma collection collect a volume of plasma product (e.g., anticoagulant and plasma mixed together) based solely on the donor's body weight; The same volume is collected from each donor of the same weight. However, the total blood volume and plasma volume for two donors can differ significantly. For example, when comparing two donors of the same weight grouped according to the FDA nomogram - one obese and one non-obese - the obese donor will actually have a lower blood volume than the non-obese donor. . Additionally, with respect to total plasma volume, donors with high hematocrit will have lower plasma volumes. In other words, because total blood volume and total plasma volume vary from donor to donor (even among donors of the same body weight), the percentage of the donor's plasma that is ultimately collected can vary widely from donor to donor. By customizing plasma collection to the donor (e.g., based on the donor's height, weight, BMI, hematocrit, total blood volume, and/or total plasma volume) and collecting a predetermined percentage of plasma from each donor, Embodiments of the invention, when compared to systems where the collection volume is not based on individual donors, collect larger volumes of plasma (e.g., pure plasma) from some donors but not from more vulnerable donors (e.g., with high hematocrit). Less plasma can be collected from smaller donors, donors with lower plasma volumes, etc.).

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 800 mL, the donor will receive 500 mL mL of saline solution). However, 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) is based on the donor's hematocrit. Based on the , the intravascular deficit will be different for each donor. In other words, the volume of saline returned to the donor may be sufficient for some but insufficient for others. By tailoring saline return to the individual donor, embodiments of the present invention can ensure that each donor has the same intravascular deficit (if present) once the procedure is completed. This, in turn, allows embodiments of the present invention to achieve isovolemia for each donor and significantly reduce any side effects the donor may experience (e.g., falls, syncope, dizziness, vasovagal reactions, etc.). enable it to be reduced.

Additionally, it is important to note that although the various embodiments discussed above relate to a blood processing system that collects plasma, the features discussed herein can be applied to any type of blood processing system. For example, features described herein may be implemented on blood processing systems that collect and/or process red blood cells, platelets, and/or white blood cells.

The embodiments of the invention described above are intended to be illustrative only, and numerous variations and modifications will be apparent to those skilled in the art. All such variations and modifications are intended to be within the scope of the invention as defined in any appended claims.

Claims (30)

A method for collecting plasma,
(a) determining the donor's weight and height;
(b) determining the donor's hematocrit;
(c) calculating a donor plasma volume based at least in part on the donor's red blood cell volume and the donor's weight and height;
(d) calculating a target plasma volume to collect based at least in part on the target percentage of plasma and the calculated donor plasma volume;
(e) withdrawing whole blood from the donor via a venous access device and a first line connected to a blood component separation device;
(f) introducing an anticoagulant into the drawn whole blood through an anticoagulant line;
(g) separating the drawn whole blood into a plasma component and at least a second blood component;
(h) collecting plasma components from the blood component separation device into a plasma collection container;
(i) continuing steps (e) through (h) until the target plasma volume to be collected in the plasma collection vessel is reached. 2. The method of claim 1, further comprising calculating a volume of anticoagulant to be collected with the plasma component in the plasma collection container, wherein the volume of anticoagulant to be collected with the plasma component is based at least in part on the donor's red blood cell volume. . 3. The method of claim 2, wherein the target volume of plasma to be collected is the target volume of pure plasma to be collected plus the calculated volume of anticoagulant to be collected. 3. The method of claim 2, wherein the target plasma volume to be collected is a target volume of pure plasma to be collected in the plasma collection vessel, and the target volume of pure plasma to be collected is at least in part the volume of anticoagulant to be collected along with the plasma components in the plasma collection vessel. Based on method. The method of claim 1 further comprising calculating the donor's body mass index based at least in part on the donor's weight and height, and wherein the donor plasma volume is calculated based at least in part on the donor's body mass index. The method of claim 1 , wherein the target plasma volume to collect is calculated prior to drawing the whole blood. The method of claim 1 , wherein the target percentage of plasma is 26.5 to 29.5 percent of the donor's plasma volume. A system for collecting plasma,
a venous access device for aspirating whole blood from a donor and returning blood components to the donor;
a blood component separation device for separating aspirated blood into a plasma component and a second blood component, the blood component separation device having an outlet and configured to direct the plasma component to a plasma collection vessel;
A first line fluidly connected to the venous access device and configured to transport aspirated whole blood to the blood component separation device and return fluid within the blood component separation device to the donor, flow 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 aspirated whole blood; and
A controller configured to control the operation of the blood component separation device and the first pump, wherein the controller (1) calculates a donor plasma volume based at least in part on the donor's red blood cell volume and the donor's weight and height, and (2) calculates the calculate a target plasma volume to collect based at least in part on the donor plasma volume and the target percentage of plasma, and (3) calculate a volume of plasma components collected within the plasma collection vessel, wherein the controller is configured to: and configured to stop the first pump when the calculated volume of plasma components is equal to the target plasma volume to be collected. 9. The system of claim 8, wherein the controller is further configured to calculate a volume of anticoagulant to be collected with the plasma component in the plasma collection container, wherein the volume of anticoagulant to be collected with the plasma component is based at least in part on the donor's red blood cell volume. . 10. The system of claim 9, wherein the target plasma volume to collect is the target volume of pure plasma to be collected plus the calculated volume of anticoagulant to be collected. 10. The method of claim 9, wherein the target volume of plasma to be collected is a target volume of pure plasma to be collected in the plasma collection vessel, and the target volume of pure plasma to be collected is at least in part the volume of anticoagulant to be collected along with the plasma components in the plasma collection vessel. and wherein the controller is configured to stop the first pump when the volume of pure plasma collected in the plasma collection vessel is equal to the target plasma collection volume. 9. The system of claim 8, wherein the controller is further configured to calculate the donor's body mass index based at least in part on the donor's weight and height, and wherein the donor plasma volume is calculated based at least in part on the donor's body mass index. 9. The system of claim 8, wherein the target plasma volume to collect is calculated prior to drawing the whole blood. 9. The system of claim 8, wherein the target percentage of plasma is 26.5 to 29.5 percent of the donor's plasma volume. A method for programming a blood processing device,
(a) receiving, in a control system, a donor's weight and height;
(b) in a control system, receiving the donor's hematocrit;
(c) calculating the donor plasma volume, using the control system, wherein the control system calculates the donor plasma volume based at least in part on the donor's hematocrit and the donor's weight and height;
(d) calculating, using the control system, a target plasma volume to collect, wherein the control system calculates a target plasma volume to collect based at least in part on the calculated donor plasma volume and the target plasma percentage;
(e) determining a target collection volume based at least in part on the calculated target plasma volume to collect; and
(f) programming the controller of the blood processing device with an endpoint of blood processing, wherein the endpoint of blood processing is based at least in part on the target collection volume. 16. The method of claim 15, wherein calculating, using the control system, a volume of anticoagulant to be collected with the plasma component in the plasma collection vessel, wherein the control system determines the volume of the anticoagulant to be collected with the plasma component based at least in part on the donor's red blood cell volume. Calculate the volume of - A method that further includes . 17. The method of claim 16, wherein the target plasma volume to collect is a target volume of pure plasma to collect, and the target volume of pure plasma to collect is based at least in part on the volume of anticoagulant to be collected with the plasma components. 18. The method of claim 17, wherein the target collection volume is a target volume of pure plasma to be collected. 18. The method of claim 17, wherein the target collection volume is the target volume of pure plasma to be collected plus the calculated volume of anticoagulant to be collected in the plasma collection vessel. 16. The method of claim 15, further comprising: using the control system to calculate the donor's body mass index based at least in part on the donor's weight and height, wherein the control system calculates the donor plasma volume based at least in part on the donor's body mass index. How to include more. 16. The method of claim 15, wherein the blood treatment end point is when the target collection volume has been collected within the plasma collection vessel of the blood processing device. 16. The method of claim 15, wherein the control system includes a controller. It is a system for collecting plasma, and the system is
blood processing devices; and
Includes a controller,
blood processing device
A venous access device for aspirating whole blood from a donor and returning blood components to the donor;
a blood component separation device for separating aspirated blood into a plasma component and a second blood component, the blood component separation device having an outlet and configured to direct the plasma component to a plasma collection vessel;
a blood aspiration line fluidly connected to the venous access device and configured to transport aspirated whole blood to a blood component separation device, the flow through the blood aspiration line being controlled by a blood aspiration pump; and
an anticoagulant line connected to an anticoagulant source, the anticoagulant line configured to introduce an anticoagulant into the aspirated whole blood;
The controller is configured to (1) calculate a donor plasma volume based at least in part on the donor's hematocrit and the donor's weight and height, and (2) target the donor plasma volume to be collected based at least in part on the calculated donor plasma volume and the target percentage of plasma. A system configured to calculate a plasma volume, and (3) calculate a target collection volume based at least in part on the calculated target plasma volume to collect. 24. The system of claim 23, wherein the blood processing device is configured to stop the blood aspiration pump when the target collection volume has been collected in the plasma collection vessel. 24. The system of claim 23, wherein the controller is part of a blood processing device. 24. The system of claim 23, wherein the controller is further configured to program the blood processing device to an endpoint of blood processing based at least in part on the target collection volume. 27. The system of claim 26, wherein the endpoint of blood treatment is when the target collection volume has been collected in the plasma collection vessel. 24. The method of claim 23, wherein the target volume of plasma to be collected is a target volume of pure plasma to be collected in the plasma collection vessel, and the target volume of pure plasma to be collected is at least in part the volume of anticoagulant to be collected along with the plasma components in the plasma collection vessel. Based on the system. 29. The system of claim 28, wherein the target collection volume is the target volume of pure plasma to be collected and/or the target volume of pure plasma to be collected plus the volume of anticoagulant to be collected in the plasma container. 24. The system of claim 23, wherein the controller is further configured to calculate the donor's body mass index based at least in part on the donor's weight and height, and wherein the donor plasma volume is based at least in part on the donor's body mass index.

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