Plasmapheresis centrifuge bowl with stationary actuating seal

Abstract

A plasmapheresis centrifuge bowl includes an outer body that is rotatable about a longitudinal axis of the plasmapheresis centrifuge bowl. The outer body has a main body defining an interior, a neck portion extending proximal to the main body, and a shoulder connecting the main body and the neck portion. Within the interior, the bowl has a separation region, and rotation of the bowl separates whole blood within the separation region into a first blood component and a second blood component. The bowl also includes an actuating seal mechanism that transitions between an open state when the plasmapheresis centrifuge bowl is rotating and a closed state when the plasmapheresis centrifuge bowl is not rotating.

Description

Priority

[0001] This PCT patent application claims priority from U.S. Provisional Application No. 63 / 606,326, filed December 5, 2023, entitled “Plasmapheresis Centrifuge Bowl with Stationary Actuating Seal,” assigned attorney docket number 130670-09901, and naming Michael Ragusa and Taylor Korytko as inventor, the disclosure of which is incorporated herein, in its entirety by reference Technical Field

[0002] The present invention relates to systems and methods for blood apheresis, and more particularly centrifuge bowls for collecting a plasma product. Background Art

[0003] Apheresis is a procedure in which individual blood components can be separated and collected from whole blood temporarily withdrawn from a subject. Typically, whole blood is withdrawn through a needle inserted into a vein of the subjects arm and into a cell separator, such as a centrifugal bowl. Once the whole blood is separated into its various components, one or more of the components (e.g., plasma) can be removed from the centrifugal bowl. The remaining components can be returned to the subject along with optional compensation fluid to make up for the volume of the removed component. The process of drawing and returning continues until the quantity of the desired component has been collected, at which point the process is stopped. A central feature of apheresis systems is that the processed but unwanted components are returned to the donor. Separated blood components may include, for example, a high density component such as red blood cells, an intermediate density component such as platelets or white blood cells, and a lower density component such as plasma.

[0004] The centrifuge bowls used by prior art collection systems utilize a rotary seal having a ceramic ring and a carbon ring that contact each other during rotation of the centrifuge bowl. During bowl spinning, the rotary seal can generate particulates from the wear surfaces, generate heat, and may limit the centrifuge speed. Each of these may a have negative impacts on the plasma collection procedure. Summary of the Invention

[0005] In accordance with some embodiments of the present invention, a plasmapheresis centrifuge bowl may include an outer body that is rotatable about a longitudinal axis of the plasmapheresis centrifuge bowl. The outer body may have a main body defining an interior, a neck portion extending proximal to the main body, and a shoulder connecting the main body and the neck portion. Within the interior, the bowl may have a separation region, and rotation of the plasmapheresis centrifuge bowl separates whole blood within the separation region into a first blood component and a second blood component. An inlet port may be used to introduce whole blood into the plasmapheresis centrifuge bowl, and the bowl may have an actuating seal mechanism. The actuating seal mechanism may transition between an open state when the plasmapheresis centrifuge bowl is rotating and a closed state when the plasmapheresis centrifuge bowl is not rotating.

[0006] In some embodiments, the bowl may also have a seal crown and a header shield. The seal crown may be secured to the neck portion of the plasmapheresis centrifuge bowl and may rotate with the plasmapheresis centrifuge bowl. The header shield may be secured to (and / or may be part of) a header assembly of the plasmapheresis centrifuge bowl and may move relative to the seal crown between a first position and a second position (e.g., in a vertical direction). The header shield may not rotate with the bowl. The actuating seal mechanism may be in the closed state when the header shield is in the first position. The actuating seal mechanism may have a sealing surface located on the seal crown, and at least a portion of the header shield may contact the sealing surface when in the first position such that the actuating seal mechanism is in the closed state. Conversely, the portion of the header assembly may not contact the sealing surface when in the second position such that the actuating seal mechanism is in the open state. Additionally or alternatively, the actuating seal mechanism may include a sealing surface located on the header shield, and a portion of the seal crown may contact the sealing surface when the header shield is in the first position such that the actuating seal mechanism is in the closed state. The portion of the seal crown may not contact the sealing surface when the header shield is the second position such that the actuating seal mechanism in in the open state.

[0007] The sealing surface may include a seal member that seals against the portion of the header shield when the header shield is in the first position. The seal member may prevent non-sterile air from entering the interior of the plasmapheresis centrifuge bowl when sealed against the header assembly and when the actuating seal mechanism is in the closed mode. The seal member may be an O-ring and / or a gasket. The first position of the header shield may be a lowered state and the second position of the header shield may be a raised state. In other embodiments (e.g., those that have the sealing surface on the header shield), the sealing surface may include a seal member that seals against the portion of the seal crown when the header shield is in the first position.

[0008] In accordance with further embodiments, the bowl may include a fluid path extending at least partially through the header shield. The fluid path may allow air to exit the interior of the plasmapheresis centrifuge bowl during filling of the plasmapheresis centrifuge bowl and when the actuating seal mechanism is in the open state. The fluid path may be tortuous and / or the bowl may have a filter located within the fluid path. The filter may allow air to flow through the fluid path and prevent particulates from entering and / or exiting the interior of the plasmapheresis centrifuge bowl.

[0009] The bowl may have at least one impeller located on the seal crown of the plasmapheresis centrifuge bowl to facilitate airflow away from the interior of the plasmapheresis centrifuge bowl. The impeller(s) may include a plurality of fan blades and the fan blades may be curved.

[0010] In further embodiments, the bowl may have a biasing member located within the header shield. The biasing member may bias the actuating seal mechanism toward the closed position. The bowl and / or the seal mechanism may also include a lifting member located within the header shield. The lifting member may interact with an actuating means to transition the actuating seal mechanism between the open state and the closed state.

[0011] In accordance with additional embodiments, an actuating seal for a plasmapheresis centrifuge bowl may include a seal crown and a header shield. The seal crown may be secured to a neck portion of the plasmapheresis centrifuge bowl and may rotate with the plasmapheresis centrifuge bowl. The header shield may be secured to a header assembly of the plasmapheresis centrifuge bowl and may move relative to (e.g., vertically) the seal crown between a first position and a second position. The actuating seal may seal the interior of the plasmapheresis centrifuge bowl when the header shield is in the first position.

[0012] The seal may also include a sealing surface located on the seal crown, and a portion of the header shield may contact the sealing surface when in the first position. The portion of the header shield may not contact the sealing surface when in the second position. The sealing surface may have a seal member that seals against the portion of the header shield when the header shield is in the first position. The seal member may prevent non- sterile air from entering the interior of the plasmapheresis centrifuge bowl when sealed against the header shield. The seal member may be an O-ring and / or a gasket.

[0013] In some embodiments, the actuating seal may also include a fluid path extending at least partially through the header shield. The fluid path may allow air to exit the interior of the plasmapheresis centrifuge bowl during filling and when the header shield is in the second position. The fluid path may be tortuous and / or the seal may have a filter located within the fluid path. The filter may allow air to flow through the fluid path and prevent particulates from entering the interior of the plasmapheresis centrifuge bowl.

[0014] In accordance with further embodiments, an actuating seal for a plasmapheresis centrifuge bowl may include a seal crown, a header shield and a lifting member. The seal crown may be secured to a neck portion of the plasmapheresis centrifuge bowl and may rotate with the plasmapheresis centrifuge bowl. The header shield may be secured to a header assembly of the plasmapheresis centrifuge bowl. The lifting member may be located within the header shield, and may transition between a first position and a second position. The actuating seal may seal the interior of the plasmapheresis centrifuge bowl when the lifting member is in the first position.

[0015] The actuating seal may include a sealing surface located on the seal crown, and a portion of the lifting member may contact the sealing surface when in the first position. Conversely, the lifting member may not contact the sealing surface when in the second position. The sealing surface may include a seal member (e.g., an O-ring or a gasket) that may seal against the lifting member when the lifting member is in the first position. The seal member may prevent non-sterile air from entering the interior of the plasmapheresis centrifuge bowl when sealed against the lifting member. Additionally or alternatively, the seal may include a sealing surface located on the header shield, and a portion of the seal crown may contact the sealing surface when the header shield is in the first position. The portion of the seal crown may not contact the sealing surface when the header shield is in the second position. The sealing surface may include a seal member that seals against the portion of the seal crown when the header shield is in the first position. In some embodiments, the seal may include a sealing surface located on the lifting member, and a portion of the seal crown may contact the sealing surface when the lifting member is in the first position. The portion of the seal crown may not contact the sealing surface when the lifting member is in the second position. The sealing surface may include a seal member configured to seal against the portion of the seal crown when the lifting member is in the first position.

[0016] A fluid path may extend at least partially through the header shield to allow air to exit the interior of the plasmapheresis centrifuge bowl during filling of the plasmapheresis centrifuge bowl and when the lifting member is in the second position. The fluid path may be tortuous. The actuating seal may have a filter located within the fluid path that allows air to flow through the fluid path and prevent particulates from entering and / or exiting the interior of the plasmapheresis centrifuge bowl.

[0017] In additional embodiments, the actuating seal may include a biasing member located within the header shield. The biasing member may bias the lifting member toward the first position. The lifting member may interact with an actuating means to transition the lifting member from the first position to the second position. The first position may be a lowered position and the second position may be a raised position. At least one impeller may be located on the seal crown to facilitate airflow away from the interior of the plasmapheresis centrifuge bowl. The impeller(s) may include a plurality of fan blades and may be curved.

[0018] In accordance with further embodiments, an apheresis device may include a plasmapheresis centrifuge bowl and an actuation mechanism. The plasmapheresis centrifuge bowl may have an outer body rotatable about a longitudinal axis of the plasmapheresis centrifuge bowl. The outer body may include a main body defining an interior, a neck portion extending proximal to the main body, and a shoulder connecting the main body and the neck portion. Within the interior, the bowl may have a separation region and rotation of the plasmapheresis centrifuge bowl may separate whole blood within the separation region into a first blood component and a second blood component. An inlet port may introduce whole blood into the plasmapheresis centrifuge bowl, and an actuating seal mechanism may transition between an open state when the plasmapheresis centrifuge bowl is rotating and a closed state when the plasmapheresis centrifuge bowl is not rotating. The actuation mechanism may transition the actuating seal mechanism between the open state and the closed state.

[0019] The actuation mechanism may include a lifting arm that translates between a lowered position and a raised position and may interact with a lifter on the actuating seal mechanism during transition of the actuating seal mechanism. In some embodiments, the lifting arm may have a strike plate that translates with the lifting arm and a plurality of electromagnets may generate an electromagnetic force to lift the lifting arm and the strike plate to transition the actuating seal mechanism from the closed state toward the open state. The lifting arm may lower upon removal of the electromagnetic force to transition the actuating seal mechanism from the open state toward the closed state. The actuation mechanism may include at least one guide rod, and the lifting arm may translate along the guide rod when translating between the lowered position and the raised position. The actuation mechanism may also include at least one spring that surrounds the guide rod(s) and biases the lifting arm toward the lowered position.

[0020] In further embodiments, the apheresis device may have a detection mechanism that detects the position of the lifting arm. For example, the detection mechanism may include a sensor that emits light towards the lifting arm, and the lifting arm may have a reflective surface that reflects the emitted light back towards the sensor when the lifting arm is in the lowered position (or the raised position). Additionally or alternatively, the detection mechanism may include a first and second conductive pin located on a lid of the apheresis device. The lifting arm may have a tab that electrically connects the first and second conductive pins when the lifter arm is in the raised position. The actuating seal mechanism may have a secondary seal that biases the actuating seal mechanism towards the closed state. The plasmapheresis centrifuge bowl may also have an alignment feature configured to interact with a second alignment feature located on a lid of the apheresis device to align the plasmapheresis centrifuge bowl with the actuation mechanism.

[0021] In additional embodiments, the actuation mechanism may include at least one lifting bar positioned below a lifter on the actuating seal mechanism and an actuator. The lifting bar may move between a lowered position and a raised position to transition the actuating seal mechanism from the closed state toward the open state. The actuator may raise the lifting bar to move the lifting bar from the lowered position toward the raised position to transition the actuating seal mechanism toward the open state.

[0022] In some embodiments, the actuation mechanism may be located below the plasmapheresis centrifuge bowl and / or may include an electromagnetic actuator to move the plasmapheresis centrifuge bowl from a lowered position to a raised position. The actuating seal mechanism may be in the closed mode when the plasmapheresis centrifuge bowl is in the raised position.

[0023] In further embodiments, the plasmapheresis centrifuge bowl may be located within a chuck of the apheresis device, and the actuation mechanism may be located below the chuck such that the electromagnetic actuator moves the chuck and the plasmapheresis centrifuge bowl from the lowered position to the raised position. Additionally or alternatively, the actuation mechanism may have a threaded gear mechanism that moves the chuck and the plasmapheresis centrifuge bowl from the lowered position to the raised position. The actuating seal mechanism may be in the closed mode when the plasmapheresis centrifuge bowl is in the raised position.

[0024] In accordance with additional embodiments, the actuation mechanism may include an arm member located on a lid of the apheresis device, and an actuator that raises and lowers the arm member and at least a portion of the lid. This, in turn, transitions the actuating seal mechanism between the open state and the closed state. Raising the arm member and the at least a portion of the lid may transition the actuating seal mechanism from the closed state toward the open state and lowering the arm member and the at least a portion of the lid may transition the actuating seal mechanism from the open state toward the closed state. Brief Description of the Drawings

[0025] The foregoing features of the invention will be more readily understood by reference to the following detailed description, taken with reference to the accompanying drawings, in which:

[0026] Figure 1 schematically shows a perspective view of a blood processing system in accordance with some embodiments of the present invention.

[0027] Figure 2 schematically shows a top view of the blood processing system of Figure 1, in accordance with some embodiments of the present invention;

[0028] Figure 3 schematically shows a disposable set installed within a blood processing system, in accordance with some embodiments of the present invention.

[0029] Figure 4 schematically shows a prior art plasmapheresis centrifuge bowl.

[0030] Figure 5 schematically shows a cross section of the prior art plasmapheresis centrifuge bowl shown in Figure 4.

[0031] Figures 6A-6C schematically show perspective views and cross section views of a first embodiment of a plasmapheresis bowl, in accordance with embodiments of the present invention.

[0032] Figures 7A-7E schematically show perspective views and cross section views of the top portion of the plasmapheresis bowl shown in Figures 6A-6C with the seal in the closed state, in accordance with embodiments of the present invention.

[0033] Figures 8A-8C schematically show perspective views and cross section views of the plasmapheresis bowl shown in Figures 6A-6C with the seal in the open state, in accordance with embodiments of the present invention.

[0034] Figures 9A-9E schematically show perspective views and cross section views of an alternative embodiment of a plasmapheresis bowl, in accordance with embodiments of the present invention.

[0035] Figures 10A-10B schematically show perspective views of a first actuation mechanism, in accordance with embodiments of the present invention.

[0036] Figures 11A-11B schematically show perspective and exploded views of a second actuation mechanism, in accordance with embodiments of the present invention.

[0037] Figures 12A-12F schematically show perspective and cross-sectional views of a third actuation mechanism, in accordance with various embodiments of the present invention.

[0038] Figures 13A-13D schematically show top views of various electromagnet configurations for the actuation mechanism shown in Figures 12A-12F, in accordance with some embodiments of the present invention.

[0039] Figure 14 schematically shows a voltage vs. time chart for the electromagnets shown in Figures 13A-13D, in accordance with various embodiments of the present invention.

[0040] Figures 15A and 15B schematically show perspective views of an alignment feature, in accordance with embodiments of the present invention.

[0041] Figures 16A and 16B schematically show actuation detection mechanisms in accordance with some embodiments of the present invention.

[0042] Figures 17A-17D schematically show cross section views of a further alternative embodiment of a plasmapheresis bowl, in accordance with embodiments of the present invention.

[0043] Figure 18 schematically shows an electromagnetic actuation mechanism for actuating the seal of the bowl shown in Figures 17A-17D, in accordance with embodiments of the present invention.

[0044] Figures 19A-19C schematically show an alternative electromagnetic actuation mechanism for actuating the seal of the bowl shown in Figures 17A-17D.

[0045] Figures 20A-20C schematically show a further alternative electromagnetic actuation mechanism for actuating the seal of the bowl shown in Figures 17A-17D.

[0046] Figure 21 schematically shows an air cylinder lifting mechanism for actuating the seal of the bowl shown in in Figures 17A-17D

[0047] Figure 22 schematically shows a threaded gear actuation mechanism for actuating the seal of the bowl shown in Figures 17A-17D, in accordance with embodiments of the present invention.

[0048] Figure 23 schematically shows an alternative electromagnetic actuation mechanism for actuating the seal of the bowl shown in Figures 17A-17D, in accordance with embodiments of the present invention.

[0049] Figures 24A-24F schematically show an alternative plasmapheresis centrifuge bowl and sealing mechanism for the plasmapheresis bowl, in accordance with embodiments of the present invention. Detailed Description of Specific Embodiments

[0050] Illustrative embodiments of the present invention provide plasmapheresis bowls for the separation and collection of plasma. The bowl may have an actuating seal mechanism that transitions between an open state when the plasmapheresis centrifuge bowl is rotating and a closed state when the plasmapheresis centrifuge bowl is not rotating. Details of the illustrative embodiments are discussed below.

[0051] As shown in Figures 1 and 2, the blood processing system 100 includes a cabinet 110 that houses the main components of the system 100 (e.g., the non-disposable components). Within the cabinet 110, the 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 the system 100 and into the drawn whole blood. Additionally, the system 100 may include a number of valves that may be opened and / or closed to control the fluid flow through the system 100. For example, the system 100 may include a donor valve 120 that may open and close to selectively prevent and allow fluid flow through a donor line 218 (e.g., an inlet line; Fig. 3), and a plasma valve 130 that selectively prevents and allows fluid flow through an outlet / plasma line 222 (Fig. 3). Some embodiments may also include a saline valve 135 that selectively prevents and allows saline to flow through a saline line 223.

[0052] To facilitate the connection and installation of a disposable set and to support the corresponding fluid containers, the system 100 may include an anticoagulant pole 150 on which the anticoagulant solution container 210 (Fig. 3) may be hung, and a saline pole 160 on which a saline solution container 217 (Fig. 3) may be hung (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 the whole blood drawn from the subject for processing and / or blood or blood components that are returned to the donor. To that end, the system 100 may include blood filter holder 170 in which the blood filter (located on the disposable set) may be placed.

[0053] As discussed in greater detail below, apheresis systems 100 in accordance with embodiments of the present invention withdraw whole blood from a subject through a venous access device 206 (Fig. 3) using the blood pump 232. As the system 100 withdraws the whole blood from the subject, the whole blood enters a blood component separation device 214, such as a prior art plasmapheresis centrifuge bowl 300 like that shown in Figure 4, (a Latham type centrifuge or other type of separation chambers and devices may alternatively be used) or a plasmapheresis bowl 600 like that described herein. The blood component separation device 214 separates the whole blood into its constituent components (e.g., red blood cells, white blood cell, plasma, and platelets). Accordingly, to facilitate operation of the separation device 214, the system 100 may also include a well 180 in which the separation device 214 may be placed and in which the separation device 214 rotates (e.g., to generate the centrifugal forces required to separate the whole blood). A lid 182 may secure the bowl 300 / 600 in place once installed.

[0054] To allow the user / technician to monitor the system operation and control / set the various parameters of the procedure, the system 100 may include a user interface 190 (e.g., a touch screen device) that displays the operation parameters, any alarm messages, and buttons which the user / technician may depress to control the various parameters. Additional components of the blood processing system 100 are discussed in greater detail below (e.g., in relation to the system operation).

[0055] FIG. 3 is a schematic block diagram of the blood processing system 100 and a disposable collection set 200 (with an inlet disposable set 200A and an outlet disposable set 200B) that may be loaded onto / into the blood processing system 100, in accordance with the present invention. The collection set 200 includes a venous access device 206 (e.g., a phlebotomy needle) for withdrawing blood from a donor's arm 208, a container of anticoagulant 210, a centrifugation bowl 300 / 600 (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 an inlet port 330 / 630 of the bowl 300, the plasma / outlet line 222 couples an outlet port 340 / 640 of the bowl 300 / 600 to the plasma collection bag 216, and a saline line 223 connects the outlet port 340 / 640 of the bowl 300 / 600 to the saline container 217. An anticoagulant line 225 connects the anti-coagulant container 210 to the inlet line 218. In addition to the components mentioned above and as shown in Figure 3, the blood processing system 100 includes a controller 226, a motor 228, and a centrifuge chuck 230. The controller 226 is operably coupled to the two pumps 232 and 234, and to the motor 228, which, in turn, drives the chuck 230. The controller 226 may be operably coupled to and in communication with the user interface 190.

[0056] 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, the blood / inlet line 218 is routed through the blood / first pump 232 and the anticoagulant line 225 from the anti-coagulant container 210 is routed through the anticoagulant / second pump 234. The centrifugation bowl 300 / 600 may then be securely loaded into the chuck 230 and the cover 182 closed to secure the bowl 300 / 600. Once the bowl 300 / 600 is secured in place, the technician may install the outlet disposable set 200B. For example the technician may connect a bowl connector to the outlet 340 / 640 of the bowl 300 / 600, install the plasma container 216 into the weight senor 195, run the saline line 223 through valve 135, and run the plasma / outlet line 222 through 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 blood processing. If the bowl 600 is equipped with an actuating seal 645 as discussed herein, the system 100 may open the seal 645 prior to starting rotation of the bowl 600.

[0057] As shown in Figure 3, the system 100 may also include an optical sensor 213 that may be applied to a shoulder portion of the bowl 300 / 600. The optical sensor monitors each layer of the blood components as they gradually and coaxially advance toward the core from the outer wall of the bowl 300 / 600. The optical sensor 213 may be mounted in a position (e.g., within the well 180) at which it can detect the buffy coat and / or the red blood cells reaching a particular radius, and, as discussed in greater detail below, the system 100 may alter the plasmapheresis in response to the detection.

[0058] Figures 4 and 5 schematically show a perspective view and a cross-sectional view of a prior art centrifuge bowl 300 (e.g., a plasmapheresis bowl). The bowl 300 has an outer body 310 that defines the structure of the bowl 300 and an inner volume 320 into which the whole blood may be introduced for processing. The outer body 310, in turn, includes a main wall 312, a neck portion 316, and shoulder portion 314 that connects the main wall 312 and the neck portion 316. The bowl 300 is rotatable about an axis in order to separate the whole blood into its various components (e.g., plasma, red blood cells, etc.).

[0059] The bowl 300 may have an inlet 330 that allows whole blood to be introduced into the bowl 300, and outlet port 340 that allows plasma (or other blood component) to be extracted from the bowl 300. To allow the inlet 330 and outlet 340 to remain stationary during bowl rotations, and as best shown in Figure 5, the prior art centrifuge bowl 300 includes a rotary seal 350 that connects the ports (e.g., the inlet 330 and outlet 340) to the outer body 310 of the bowl 300. The rotary seal 350 may include two rings (e.g., a ceramic ring 351A and a carbon ring 35IB). One ring (e.g., the ceramic ring 351 A) is attached to the seal crown 356 which, in turn, is attached to the outer body 310. The rotary seal 350 allows the bowl 300 (and a core 500 within the interior) to spin while the inlet 330 and outlet 340 remain stationary. The ceramic ring 351A and the carbon ring 35IB remain in contact to create a seal when the bowl 300 is stationary and when the bowl 300 is spinning. When spinning, the carbon ring 35 IB transfers carbon onto the surface of ceramic ring 351A to create a lubricious surface for articulation / rotation. Although the two rings 351A / B create a seal and prevent significant amounts of non-sterile air from entering the bowl 350, as discussed above, this rotary seal design can generate particles from the wear surfaces, generate heat that can damage / bum the plasma (or other blood components) being collected, and may limit the centrifuge speed. Each of these may have negative impacts on the plasma collection procedure.

[0060] To prevent the negative features and impact of the prior art bowl discussed above, various embodiments of the present invention utilize a seal mechanism that only provides contact between the rotating and stationary components of the bowl when the bowl is not spinning (e.g., during return phases and during storage). For example, as shown in Figures 6A to 6C, the plasmapheresis centrifuge bowl 600 may include a similar configuration to that shown above. In particular, the bowl 600 has an outer body 610 that defines the structure of the bowl 600 and an inner volume 620 into which the whole blood may be introduced for processing. The outer body 610, in turn, includes a main wall 612, a neck portion 616, and shoulder portion 614 that connects the main wall 612 and the neck portion 616. The bowl 600 is rotatable about an axis in order to separate the whole blood into its various components (e.g., plasma, red blood cells, etc.). To facilitate fluid flow in and out of the bowl 600, the bowl 600 may have an inlet 630 that allows whole blood to be introduced into the bowl 600, and an outlet port 640 that allows plasma (or other blood component) to be extracted from the bowl 600.

[0061] To connect the inlet 630 and the outlet 640 (collectively the header assembly 655) to the outer body 610 of the bowl 600, the bowl 600 may include a seal crown 650 that is secured to the neck portion 616 (e.g., at the opening 615 to the interior 620 of the bowl 600) and a header shield 660 that is connected to the header assembly 655. Within and connected to the header shield 660, the bowl 600 may include a lifting member 670. In some embodiments, the ends 676A / B of the lifting member 670 may extend out beyond the header shield 610 (Fig. 6C) and may interact with an actuator to transition the lifting member 670 from a first position / state (e.g., see Figures 7A-7E) to a second position (see, Figures 8A-8C). Alternatively, in other embodiments, the ends 676A / B may not protrude out beyond the header shield 610 and the bars / actuator (discussed in greater detail below) may extend further into the header shield 610 to make contact with the lifting member 670. In the embodiment shown in the above figures, the first position is a lowered position and the second position is a raised / lifted position.

[0062] It should be noted that, although the figures show the seal crown 650 as being a separate part from the neck portion 616 and / or bowl 600, other embodiments may have alternative configurations. For example, the seal crown 650 may be integrally formed with the neck portion 616 (and the remainder of the body 610). In such embodiments, the outer body 610 of the bowl 600 and the seal crown 650 may be formed as a single piece (e.g., via injection molding or similar process).

[0063] As best shown in Figures 7A-7E, when in the first / lowered position, a portion of the lifting member 670 (e.g., a first seal surface 672) contacts a surface on the seal crown 650 (e.g., a second seal surface 652) to provide a seal and prevent contaminants from entering the interior / inner volume 620 of the bowl 600. This seal can be provided simply by the surface to surface contact between the lifting member 670 and the seal crown 650 (e.g., from the first seal surface 672 contacting the second seal surface 652). Alternatively, as shown in Figures 7C-7E, the seal crown 650 may include a sealing member 680 (e.g., an O-ring or a gasket) against which the lifting member 670 and the first seal surface 672 can seal. As discussed in greater detail below, the lifting member 670 may remain within the first position during storage and / or during times when the bowl 600 is stopped during processing (e.g., during a return phase).

[0064] After installation of the bowl 600 into the plasma collection device / system 100 and prior to the start of centrifugation (e.g., before the bowl 600 starts spinning), the system 100 may transition the lifting member 670 to the second position (e.g., in the embodiment shown in Figures 6A-6C and 7A-7E to the lifted position shown in Figures 8A-8C). When in the lifted position, the lifting member 670 is lifted off of the second sealing surface 652 on the seal crown 650, unsealing the lifting member 670 and the seal crown 650 and allowing the seal crown 650 to freely rotate with the bowl 600. It should be noted that, although the lifting member 670 is shown extending out perpendicularly with respect to the inlet 630 and outlet 640, other embodiments can have different configurations. For example, in some embodiments, the lifting member 670 may extend parallel to the inlet 630 and outlet 640.

[0065] In some embodiments, the bowl 600 may also include a secondary seal 690 that acts as a biasing member that biases the lifting member 670 toward the first / lowered state. In particular, the secondary seal 690 may be connected to the lifting member 670 at one end and the header shield 610 at the other end and provide a downward force on the lifting member 670 that biases the lifting member 670 back to the lowered position when actuation is removed (discussed in greater detail below). This downward force maintains the sterile barrier through shelf-life / storage and is significant enough to allow for a large enough negative pressure to return the contents of the bowl 610 during the return phase. The seal also allows the system 100 to pull saline at the end of the procedure through the bowl 600 and return the saline to the donor.

[0066] As best shown within Figure 7E, the seal crown 650, the lifting member 670 and / or the header shield 610 may define a fluid path 700 that is closed off when the lifting member 670 is in the first / lowered state (e.g. because of the seal between the lifting member 670 and the seal crown 650) and open when the lifting member 670 is in the second / lifted state. When open, the fluid path 700 may allow some air to escape from the bowl 600 (e.g., in addition to air that may be exiting the bowl 600 via the effluent channel, discussed in greater detail below), for example, during filling of the bowl 600. The continuous influx of blood into the bowl 600 and / or the circulating airflow from the centrifugation prevents non-sterile air or foreign particles from entering the bowl and the fluid dynamics will prevent any escape of blood through the interface. For example, the inner diameter of the seal crown 650 may be smaller than the outer diameter of the effluent skirt 840 (Fig. 6B / 6C) which prevents blood from escaping through the interface.

[0067] To create a further barrier against particulate ingress into the bowl 600, the fluid path 700 may be torturous. For example, the seal crown 650 may have a series of projections 654 that extend upwards and the lifting member 670 may have a series of projections 674 that extend downward from the lifting member 670. These projections 654 / 674 may alternate with one another such that the seal crown projections 654 are located between the lifting member projections 674 to create the tortuous path. Additionally or alternatively, the bowl 600 may include a filter 710 (Fig. 9A and 9B) within the fluid path 700 that allows air to pass through it and the fluid path 700, but prevents particulates from entering the inner volume 620 of the bowl 600. In such embodiments, the filter may be located on the seal crown 650 or on the lifting member 670.

[0068] As noted above, the lifting member 670 is raised while the bowl 600 is spinning so that the sealing surface 652 on the seal crown 650 and the sealing surface 672 on the lifting member 670 are not in contact. While the bowl 600 is spinning, there is significant airflow in the centrifuge that acts like an air curtain to prevent particulate ingress. As shown in Figures 9A-9E and to further increase the air flow away from the opening of the bowl 600, the bowl 600 may include impellers / fan blades 720 located on the seal crown 650. The fan blades 720 may have any number of configurations including, but not limited to, forward curved (shown in Figure 9B), backward curved, or radial / straight. Additionally, as shown in Figures 9C-9E, the blades / impellers 720 may have an open configuration (Fig. 9C), a semiopen configuration (Fig. 9D) and / or an enclosed configuration (9E). It should be noted that, although the embodiment shown in Figures 9A-9E utilize fan blades 720, other embodiments may utilize other features (e.g., dimples, bumps, other protrusions) to increase the air flow. Furthermore, the rotational speed of the bowl 600 and impellers 720 and the impeller 720 design impact the volume and velocity of airflow created.

[0069] In some embodiments, it may be beneficial to introduce the whole blood near the bottom of the bowl 600. To that end, the bowl 600 may include a feed tube 800 that extends from the header assembly 655 of the bowl 600 into the interior 620 of the bowl 600. As shown in Figures 6B and 6C, the feed tube 800 includes a tubular member 810 with a flow path 820 extending through it to allow the whole blood to flow through the feed tube 800. One end of the tubular member 810 (e.g., the proximal end 812) and the flow path 820 is fluidly connected to the inlet port 630. At the distal end 814 of the tubular member 810, the feed tube 800 has an extension tube 830 that extends from the tubular member 810, through a core 900 (discussed in greater detail below) and toward the bottom of the bowl 600 (e.g., so that liquid flowing through the feed tube 600 is discharged at the base 613 of the bowl body 610).

[0070] Nearer the distal end 814 of the tubular member 810, the feed tube 800 has a skirt 840 that extends radially outward from the tubular member 810. The skirt 840 and a second skirt / disk 860 on the header assembly 655 of the bowl 600 may form an effluent channel 862 that is fluidly connected to the outlet 640 to allow blood components within a collection chamber 930 (discussed in greater detail below) to exit the bowl 600.

[0071] As noted above, various embodiments of the present invention include a core 900 located within the interior of the bowl 600. The core 900 may include a cylindrical body 910 that defines the overall structure of the core 900. Within the interior of the cylindrical body 910, the core 900 includes a ledge 920 that extends radially inward from the inner surface of the cylindrical body 910. The portion of the cylindrical body 910 located above the ledge 920 and the ledge 920 form a collection chamber 930 within the interior of the core 900 and in which the effluent channel 862 (formed by the skirts 840 / 860) is located (e.g., so that the plasma may be extracted from the collection chamber 930.

[0072] As noted above, to open the actuating seal 645, the lifting member 670 may be raised (e.g., from a first position to a second position) to lift the lifting member seal surface 672 off of the seal crown sealing surface 652. To actuate the actuating seal 645 and the lifting member 670, some embodiments of the system 100 may have various actuation mechanisms. For example, as shown in Figures 10A and 10B, the system 100 may have one or more bars 1010 (Figures 10A and 10B show two) that are fixed relative to the lid 182 of the well 180 with brackets that allow the bars 1010 to move up and down. When the bowl 600 installed, the bars 1010 may be located under the lifting member 670 (e.g., the ends 676A / B extending beyond the header shield 660). Prior to the bowl 600 spinning, a series of actuators 1020 may then raise the bars 1010 to lift the lifting member 670 and unseal the actuating seal 645. The bars 1010 may be countered by a downward spring force that forces the lifting member 670 back toward the lowered / sealed position once the actuators 1020 are no longer acting on the bars 1010.

[0073] Figures 11A and 1 IB show an alternative actuation mechanism that may be used to raise and lower the lifting member 670. In this version, the actuators 1020 may be built directly into the lid / cover 182 of the well 180 and, when actuated, may lift the bars 1010 (or similar structure such as a wedge) which, in turn, lifts the lifting member 670 to open the actuating seal 645. The actuation mechanisms described above and shown in Figures 10A-10B and 11A-11B can be pneumatic, mechanical and / or electromagnetic. Actuation mechanisms using electromagnetic actuators may include a coil 1030 that may be energized to lift a magnet 1040 and the bars 1010.

[0074] Figures 12A-12F show a further actuation mechanism that may be used to transition (e.g., open and close) the actuating seal 645. For example, like the embodiment shown in Figure 10A-10B and 11A-11B, the system 100 may have bars / lifting pieces 1050 that are located on the cover 182 and sit below the lifting member 670 located on the bowl 600 when the bowl is installed into the system 100 and may raise and lower to actuate the seal 645. In such embodiments, the lifter / lifting piece 1050 may include a strike plate 1055 that is secured to (or integral with) the lifting piece 1050 such that the strike plate 1055 moves with the lifting piece 1050 as it is raised and lowered. As best shown in Figure 12B, the system 100 may have guide rods 1057 that extend through the lifting piece 1050 and into the cover 182. Additionally, surrounding each of the screws / rods 1057, the lifting mechanism may have preloaded springs 1058 that can bias the lifting pieces 1050 downward to close the actuating seal 645.

[0075] To actuate the mechanism and lift the lifting pieces 1050 to open the actuating seal 645, the system may 100 include electromagnets 1060 located within the cover 182 (see Figures 12A, 12B, 12D, 12F and 13A-13D) that may be activated by voltage manipulation to provide “Pull-Adhere-Drop” actuation (Figure 14) . For example, once the bowl 600 has been loaded into the system 100 and prior to bowl spinning, the electromagnet(s) 1060 may be activated to create a pull force 1062 that is exerted on the strike plate 1055. This, in turn, will cause the strike plate 1055 and the lifting piece 1050 to move upwards along moves the guide rails / rods 1057 until the strike plate 1055 contacts the cover 182 and / or the electromagnets 1060. As the lifting piece 1050 travels upwards it engages the lifting member 670 on the plasmapheresis bowl 600 to open the actuation seal 645 in a manner similar to that described above. Once the seal 645 is open, the bowl body 610 is free to spin.

[0076] After the lifter / lifting piece 1050 is raised up and the plasmapheresis bowl 600 is spinning (e.g., to separate the whole blood during the apheresis procedure), the electromagnet(s) 1060 keeps the lifting piece 1050 raised by exerting a constant magnetic force 1064 onto the strike plate 1055 that is attached to the lifter 1050. When the system 100 is ready to return the remaining blood components to a patient and the bowl 600 stops spinning, the electromagnets 1060 on the centrifuge cover 182 are disconnected from their power source and the electromagnetic adhesion force is deactivated 1066. The secondary seal 690 (and perhaps the pre-loaded springs 1058) acts as a spring to close the seal 645 by lowering the lifter / lifting piece 1050. The seal 645 then remains closed and the bowl 600 remains stationary during blood return.

[0077] It is important to note and as shown in Figures 13A-13D, any number of electromagnets 1060 may be used to raise the lifter / lifting piece 1050 and open the seal 645 and the number may be dependent on a variety of factors, including the amount of force required, the size of the bowl 600, the size of the electromagnets 1060, the number of lifters / lifting pieces 1050 that need to be lifted, the size of the strike plates 1055, etc. For example, the system 100 may include one electromagnet 1060 on each side (see Figure 13B), two electromagnets 1060 on each side (see Figure 13C), three electromagnets 1060 on each side (see Figure 13D), or more than three electromagnets on each side. Additionally, if the system 100 has limited space to accommodate the electromagnets 1060, the electromagnets 1060 may be moved to outside of the centrifuge well 180, while keeping the lifter / lifting piece 1050 within the centrifuge well 180.

[0078] It should be noted that, to help dissipate heat generated by the electromagnets 1060, the lid 182 may include a heat sink or may be made from a heat dissipating material that provides a heat sink function. Additionally, because the bowl 600 is spun at a high rate of speed, the airflow created by the spinning bowl 600 may provide air cooling for the electromagnets 1060.

[0079] In some embodiments, the bowl 600 may include alignment features that automatically align the bowl 600 within the system 100 an ensure that the lifter / lifting piece 1050 is located below the lifting member 670 on the bowl 600, alleviating the need for the user to maintain alignment when closing the lid 182. For example, as shown in Figures 15A and 15B, the bowl 600 may have an alignment feature 1222 that interacts with a corresponding feature 1224 on the collar 1126 of the lid 182. When closing the centrifuge cover / lid 182, the self-alignment feature 1222 on the plasmapheresis bowl 600, in conjunction with the mating self-alignment feature 1224 on the collar 1220, will rotate the plasmapheresis bowl 600 into the correct position for blood collection.. The self-alignment feature 1224 may be located on the centrifuge cover assembly 182 (either on the collar 1220, on the cover / lid 182, or on the cover / lid 182 and the collar 1220 combined as one) and the feature 1222 on the bowl 600 may be located on a stationary part of the bowl 600 that engages with the centrifuge cover / lid 182. These alignment features 1222 / 1224 allow the lid / cover 182 to be closed with fewer potential user issues stemming from the inability to maintain proper alignment, saving time during the procedure.

[0080] In some cases, it may be beneficial to monitor the actuation mechanisms to determine / monitor the position of the lifter / lifting piece 1050 and determine if the actuating seal 645 is open or closed. To that end, the system 100 may have a position detection system to detect whether the lifter / lifting piece 1050 is lifted up or set down. For example, as shown in Figure 16A, the system 100 may have a sensor 1070 that emits light and the lifter 1050 may have a reflective surface 1052. When the lifter 1050 is in the lowered position, the reflected surface 1052 may reflect the emitted light back towards the sensor 1070, which may then detect the reflected light, indicating that the lifter 1050 is in the lowered position. Conversely, when the lifter 1050 is up (e.g., when the actuating seal 645 is open), the light emitted by the sensor 1070 will not contact the reflective surface 1052 and the light will not be reflected back toward the sensor 1070. Alternatively, the sensor 1070 and / or the reflective surface 1052 may be positioned such that the emitted light hits the reflective surface 1052 and the sensor 1070 detects the reflected light when the lifter 1050 is in the raised position.

[0081] Additionally or alternatively, the position detection system may be a conductive detection system (Fig. 16B). In such embodiments, the system 100 may have electrically-isolated conductive pins 1080 located on the centrifuge top cover / lid 182 and the strike plates 1055 may include tabs 1056. When the electromagnets 1060 are activated and the lifter 1050 and strike plates 1055 move towards and come into contact with the lid 182 or electromagnets 1060, the tabs 1056 on the plates 1055 will electrically connect the pins 1080, indicating that the lifter 1050 is in the raised position and the actuating seal 645 is open. The two pins may be wired to a printed circuit board assembly 1082 (PCBA) which detects if the electrical short is present by sending and receiving a small current across the pins 1080.

[0082] Although the embodiment discussed above includes a secondary seal 690 that biases the lifting member 670 toward the sealed / lowered position, as shown in Figures 17A-17D, other embodiments may not have the lifting member 670 and / or the secondary seal 690. In such embodiments, the header shield 660 is free-floating and is not biased toward the lowered position. To create the seal during storage and when the bowl 600 is not spinning, the bowl 600 may include a sealing member 680 (e.g., a sealing gasket) on the seal crown 650 and / or the header shield 660. In embodiments in which the sealing member 680 is located on the seal crown 650, the edge 662 of the header shield 660 may contact the seal member 680 to create the seal. Conversely, if the sealing member 680 is located on the header shield 660 (Fig. 17D), the top surface of one of the projections 654 on the seal crown 650 may contact the seal 680. Additionally, because this embodiment does not include the lifting member, the fluid path 700 may be formed between the seal crown 650 and the header shield 660. For example, the protrusions 654 extending upward from the seal crown 650 and protrusion 664 extending downward from the header shield 660 may form the tortuous fluid path 700.

[0083] It is important to note that because the embodiment shown in Figures 17A-17D is not biased toward the sealed position, this embodiment requires additional features to keep the header shield 660 in the lowered / sealed position during storage and after completion of the plasma collection (e.g., so that blood / blood component or other fluid remaining within the bowl 600 does not spill out through the fluid path 700). For example, the bowl 600 may have a closure mechanism (e.g., a “pill-bottle” like closure) that allows the user to push down on the header shield 660 and twist to lock the header shield 660 in the lowered / sealed position. Alternatively, a clip or piece of adhesive tape may be used.

[0084] Like with the embodiments described above having the lifting member 670, the system 100 may include actuating mechanisms to open and close the seal 645 within the embodiment shown in Figures 17A-17D. However, in contrast to the actuating mechanisms described above that raise the lifting member 670, the actuating mechanisms for the “free-floating” embodiment, may raise the bowl 600 rather than a lifting member. For example, as shown in Figure 18, the system 100 may have an electromagnetic actuator 1100 located below the chuck 230 that raises and lowers the chuck 230 (and the bowl 600) to open and close the seal 645. To that end, the system 100 may include a coil 1110 that may be energized to drive a magnet 1120 located on the bottom of the chuck 230 away from the coil 1110. This in turn, raises the chuck 230 and the bowl 600 to close the gap between the header shield 660 and the seal crown 650 and close the seal 645 (e.g., to seal the header shield 660 against the sealing member 680 located on the seal crown 650 or seal the seal crown 650 against a sealing member 680 located on the header shield 660). Conversely, when the seal 645 needs to be opened, the system 100 may de-energize the coil 1110 to allow the chuck 230 and the bowl 600 to drop back to the starting position and open the gap between the header shield 660 and the seal crown 650.

[0085] Figures 19A-19C show an alternative electromagnetic actuation mechanism for lifting and dropping the bowl 600 to close and open the seal 645. The actuation mechanism may include one or more electromagnets that are located outside of the chuck 230. The electromagnets 1060 may be activated and deactivated in a manner similar to the “pull-adhere-drop” actuation discussed above and shown in Figure 14. To that end, the electromagnets 1060 may be mounted to the system 100 using a mounting bracket 1061 such that the electromagnets 1060 are located outside and below the portion of the chuck 230 in which the bowl 600 sits. A metal strike plate 1055 may be located on a flange portion 231 of the chuck 230. To lift the chuck 230 (and close the seal 645), the electromagnet 1060 may be activated to create a pull force 1062 that is exerted on the strike plate 1055. This, in turn, will cause the strike plate 1055 and the chuck 230 (and bowl 600) to travel upwards and close the gap between the header shield 660 and the seal crown 650 and close the seal 645 (e.g., to seal the header shield 660 against the sealing member 680 located on the seal crown 650 or seal the seal crown 650 against a sealing member 680 located on the header shield 660). Once the seal 645 is closed, the electromagnet may keep the chuck 230 raised by exerting a constant magnetic force 1064 onto the strike plate 1055.

[0086] When the system 100 is ready for the bowl 600 to begin spinning, the electromagnets 1060 may be disconnected from their power source and the electromagnetic adhesion force may be deactivated 1066, causing the chuck 230 to lower back down to its lowered position. As the chuck 230 drops, the gap between the header shield 660 and the seal crown 650 will open to open the seal 645 and allow the bowl 600 to spin.

[0087] Although the embodiment shown in Figures 19A-19C show the electromagnets 1060 located outside the chuck 230, other embodiments may utilize electromagnets 1060 that are mounted / installed inside the chuck 230. For example, the electromagnets 1060 may be located under the chuck flange 231 and secured to the chuck base 233, and the strike plates 1055 may be secured to the bottom of the chuck 230 (e.g., on the bottom of the flange 231). In a manner similar to that described above, when the electromagnet 1060 is activated to create the pull force 1062 that is exerted on the strike plate 1055, the strike plate 1055 and the chuck 230 (and bowl 600) will travel upwards to close the gap between the header shield 660 and the seal crown 650 and close the seal 645. Once the seal 645 is closed, the electromagnet may keep the chuck 230 raised by exerting a constant magnetic force 1064 onto the strike plate 1055. Once again, to open the seal 645, the electromagnets 1060 may be disconnected from their power source to remove the pull force and allow the chuck 230 to return to the lowered position.

[0088] The actuation mechanisms shown in Figures 19A-19C and 20A-20C may also include a position sensor 1070 like those described above. For example, the sensor 1070 may be located on the wall of the system 100 and may emit a light towards a reflective surface on the chuck 230 (e.g., the flange 231) (Fig 19B) or the strike plate 1055 (Fig. 20B) to determine if the chuck 230 is in the lowered (or raised) position.

[0089] It should be noted that the strike plate(s) 1055 may include single plate located under each of the electromagnets 1060. Alternatively, the strike plate 1055 may be a ring that extends around the circumference of the chuck 230. Additionally, once again, any number of electromagnets 1060 may be used depending on the required lifting force. To ensure that an even force is exerted on the chuck 230, the electromagnets may be spaced evenly around the chuck 230.

[0090] As shown in Figure 21, the system 100 may utilize an air cylinder to actuate the seal 645. In such embodiments, the actuation mechanism may include lifting bars 1142 that are located under an undercut 235 of the chuck 230. The lifting bars 1142 are connected to an air cylinder actuator that, in turn, is connected to a compressor (not shown) located within the system 100. When the seal 645 needs to be closed, the air cylinder / compressor may provide a supply of air to the air cylinder actuator to raise the lifting bars 1142, which, in turn, raises the chuck 230 and bowl 600. Conversely, when the air supply is removed, the lifting bars 1142 may drop, allowing the chuck 230 and bowl 600 to lower and the seal 645 to open. Alternatively, the lifting bars 1142 may be raised and lowered using electromagnetic actuators in a manner similar to that described above.

[0091] Alternatively, as shown in Figure 22, the system 100 may utilize a mechanical / threaded-gear mechanism to actuate the bowl 600 and the seal 645. The mechanism may include a threaded gear 1130 (e.g., a Z-direction transfer gear) that contacts a second gear 1131 that is rotated by a stepper motor 227, for example, within the motor assembly 228 that can raise and lower the chuck 230 and / or the motor assembly 228 to open and close the seal 645. It should be noted that, if the bowl 600 is held by the lid 182 such that the seal 645 is in the closed state upon installation of the bowl 600, then the threaded gear 1130 must be lowered to lower the bowl 600 and open the seal 645 prior to spinning the bowl. Conversely, if the bowl 600 is held by the lid 182 such that the seal 645 is in the open state upon installation of the bowl 600, then the threaded gear 1130 must be raised to raise the bowl 600 and close the seal 645 when the bowl 600 is stopped.

[0092] Figure 23 shows an additional alternative actuating mechanism that lifts a portion of the lid 182 to actuate the seal 645. In such embodiments, the bowl 600 may include an arm member 1140 located on the top of the lid 182 and an actuator 1150 (e.g., a mechanical, electromagnetic, pneumatic actuator) may raise the arm member 1140 and a portion of the lid 182. This allows the header shield 660 to raise with the lid 182 to open the air gap between the header shield 660 and the seal crown 650 and open the seal 645. Conversely, to close the seal 645, the actuator 1150 may lower the arm member 1140 and the lid 182 to close the seal 645.

[0093] Figures 24A and 24B show an alternative centrifuge bowl 600 that does not have a sealing mechanism built into the bowl 600. Rather, as shown in Figures 24C-24F, the sealing mechanism may be incorporated into the lid 182 and may actuate in the X-direction (e.g., as opposed to the Z-axis actuation discussed above). The lid 182 may have a double cam / split gasket 1210 (Figs. 24C-24F) that can translate in the X-direction within a collar 1220 on the lid 182 and seal / unseal against the side of the bowl 600 (e.g., against the seal crown 650). To accommodate the gasket 1210 sealing against the side of the bowl 600 / seal crown 650, the header shield 660 may be shorter (or the seal crown 650 may be taller) than the embodiments discussed above in order to provide access to the side of the bowl 600 / seal crown 650. While the bowl 600 is spinning, the gasket 1210 may be in a retracted state in which it does not seal against the bowl 600. However, when the bowl 600 stops spinning an actuator 1230 may move the two halves of the split gasket 1210 towards the bowl 600 until it contacts and seals against the side of the bowl 600 (and each other) to block the fluid path 700. In a manner similar to that described above, the actuator 1230 may be a mechanical actuator, pneumatic actuator or an electromagnetic actuator.

[0094] It should be noted that the any of the actuation methods / systems described above may be performed manually by the user and / or by the system software. For example, the user may manually actuate the systems / components when appropriate (e.g., by pressing a button on the system 100 or other manual manipulation). Alternatively, the system 100 (e.g., the system controller 226 or software) may automatically activate the actuation mechanisms at the appropriate times to open or closed the actuating seal 645.

[0095] During use and after lines 222 / 223 are connected and the bowl 600 is installed into the system 100 (or prior to installing the bowl 600 for the embodiments shown in 17A-17D), the user may open the actuating seal 645 using the actuation mechanisms discussed above or by opening the closure mechanism / removing the clip / tape. The user / technician may then insert the venous access device 206 into the donor's arm 208 and the controller 226 may activate 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, anticoagulant from container 210 to be introduced into the drawn whole blood, and the now anticoagulated whole blood to be delivered to the inlet port 330 of the bowl 300.

[0096] It should be noted that the anticoagulant line 225 may also include a bacteria filter (not shown) that prevents any bacteria in the anticoagulant source 210, the anticoagulant, or the anticoagulant line 225 from entering the system 100 and / or the subject. Additionally, the anticoagulant line 225 may include an air detector 140 that detects the presence of air within the anticoagulant. The presence of air bubbles within any of the system 100 lines can be problematic for the operation the system 100 and may also be harmful to the subject if the air bubbles enter the blood stream. Therefore, the air detector may be connected to an interlock that stops the flow within the anticoagulant line 225 in the event that an air bubble is detected (e.g., by stopping the anticoagulant pump 234), thereby preventing the air bubbles from entering the subject.

[0097] As the anti-coagulated whole blood is withdrawn from the subject and introduced into the plasmapheresis bowl 600. The whole blood will flow through the feed tube 800 and extension tube 830 and into the bowl 600 near the bottom 613 of the bowl 600. If equipped, air will exit the bowl 600 via the fluid path 700 as the bowl 600 fills. The centrifugal forces caused by the bowl rotation will cause the whole blood to move toward the outer wall 612 of the bowl 600, and the blood component separation device 214 (e.g., the bowl 600) will separate the whole blood into several blood components. For example, the bowl 600 may separate the whole blood into a first, second, third, and, perhaps, fourth blood component. More specifically, the bowl 600 (and the centrifugal forces created by rotation of the bowl 600) can separate the whole blood into plasma, platelets, red blood cells (“RBC”), and, perhaps, white blood cells (“WBC”). The higher density component, i.e., RBC, is forced to the outer wall of the bowl 600 while the lower density plasma lies nearer the core 900. A buffy coat is formed between the plasma and the RBC. The buffy coat is made up of an inner layer of platelets, a transitional layer of platelets and WBC and an outer layer of WBC.

[0098] As shown in Figure 3 and as briefly discussed above, the system 100 may also include an optical sensor 213 that may be applied to a shoulder portion 614 of the bowl 600. The optical sensor 213 monitors each layer of the blood components as they gradually and coaxially advance toward the core from the outer wall of the bowl 600. The optical sensor 213 may be mounted in a position (e.g., within the well 180) at which it can detect the buffy coat and / or the red blood cells reaching a particular radius, and the steps of drawing the whole blood from the subject / donor and introducing the whole blood into the bowl 600 may be altered and / or terminated in response to the detection.

[0099] Once the bowl 600 has separated the blood into the various components, one or more of the components can be removed from the bowl 600. For instance, as additional anticoagulated whole blood enters the bowl 600, the plasma will be forced further inward toward the core 900 until it flows over into the collection chamber 930. When the collection chamber 930 fills with plasma such that the plasma within the collection chamber 930 makes sufficient contact with the skirts 840 / 850 and effluent channel 862, the plasma will begin exiting the bowl 600 via the effluent channel 862 and the outlet 640. Once out of the bowl 600, the plasma will flow through line 222 and into the plasma collection container 216. 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 or pre-determined volume of plasma is collected within the plasma collection container 216.

[00100] As noted above, in some embodiments, the system 100 may also include a line sensor 185 that can determine the type of fluid (e.g., plasma, platelets, red blood cells etc.) exiting the bowl 600. In particular, the line sensor 185 consists of an LED which emits light through the blood components leaving the bowl 600 and a photo detector which receives the light after it passes through the components. The amount of light received by the photo detector is correlated to the density of the fluid passing through the line. For example, if plasma is exiting the bowl 600, the line sensor 185 will be able to detect when the plasma exiting the bowl 600 becomes cloudy with platelets (e.g., the fluid existing the bowl 600 is changing from plasma to platelets). The system 100 may then use this information to either stop the removal of blood components from the bowl 600, stop drawing whole blood from the subject, stop the bowl 600, or redirect the flow by, for example, closing one valve an opening another.

[00101] Once the system 100 has collected the target volume of plasma within the plasma collection container 216 or the bowl 600 is full of red blood cells (e.g., between collection cycles), the system 100 can return the remaining components (e.g., the components remaining within the bowl 600) to the subject. For example, when all the plasma has been removed and the bowl 600 is full of RBCs (and any other blood component not collected), the controller 226 stops the draw of whole blood from the subject and slows and / or stops the bowl 600. As the bowl 600 slows and / or stops, and fluid remaining within the collection chamber 930 will drain out of the collection chamber 930. Once the bowl 600 has stopped, the air curtain preventing the ingress of particulates stops. In order to seal and maintain the sterility of the interior 620 of the bowl 600, the system 100 may then close the actuating seal 645 in one of the manners described above. The system 100 / controller 226 may then reverse the direction of the blood / first pump 232 to draw the RBCs (and other components) from the bowl 600 and send them back to the subject. Alternatively, if the system 100 is so equipped, the system 100 may return the components to the subject via a dedicated return line.

[00102] In addition to the non-collected blood components (e.g., the components remaining in the bowl 600), the system 100 may also return saline to the patient / subject. The saline may be used as a compensation fluid to make up for the volume of the blood component (e.g., plasma) that was removed and collected, and is not being returned to the patient. To that end, during the return step, 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 600 (via outlet 640), where it can be returned to the patient / donor with or after the remaining blood components. If additional plasma collection cycles are to be performed (e.g., if the volume of plasma already collected does not equal the target / pre-determined volume), the system 100 may once again open the actuating seal 645 and start the blood / first pump 232 to withdraw whole blood from the subject and the system 100 may repeat the process above until the target volume of plasma is collected.

[00103] It should be noted that embodiments of the present invention provide numerous benefits over prior art bowls. For example, because various embodiments of the present invention incorporate an actuating seal (e.g., as opposed to the rotary seal used by prior art bowls), the bowls described herein are able to only seal when the bowl is not spinning. This, in turn, reduces the particulate and heat generation that can negatively impact the collected blood components. Additionally, because the seal crown is able to freely rotate with respect to the header assembly, the speed of the centrifuge may be increased without additional particle or heat generation.

[00104] It is important to note that, although the various embodiments discussed above are in relation 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 blood processing systems that collect and / or process red blood cells, platelets and / or white blood cells.

[00105] The embodiments of the invention described above are intended to be merely exemplary; 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 present invention as defined in any appended claims.

Claims

1. A plasmapheresis centrifuge bowl comprising:an outer body rotatable about a longitudinal axis of the plasmapheresis centrifuge bowl, the outer body having a main body defining an interior, a neck portion extending proximal to the main body, and a shoulder connecting the main body and the neck portion;a separation region located within the interior, rotation of the plasmapheresis centrifuge bowl separating whole blood within the separation region into a first blood component and a second blood component;an inlet port for introducing whole blood into the plasmapheresis centrifuge bowl; andan actuating seal mechanism configured to transition between an open state when the plasmapheresis centrifuge bowl is rotating and a closed state when the plasmapheresis centrifuge bowl is not rotating.

2. A plasmapheresis centrifuge bowl according to claims 1, further comprising:a seal crown secured to the neck portion of the plasmapheresis centrifuge bowl and configured to rotate with the plasmapheresis centrifuge bowl; anda header shield secured to a header assembly of the plasmapheresis centrifuge bowl and configured to move relative to the seal crown between a first position and a second position, the actuating seal mechanism in the closed state when the header shield is in the first position.

3. A plasmapheresis centrifuge bowl according to claim 2, wherein the actuating seal mechanism includes a sealing surface located on the seal crown, at least a portion of the header shield contacting the sealing surface when in the first position such that the actuating seal mechanism is in the closed state.

4. A plasmapheresis centrifuge bowl according to claim 3, wherein the at least a portion of the header assembly does not contact the sealing surface when in the second position such that the actuating seal mechanism in in the open state.

5. A plasmapheresis centrifuge bowl according to claim 3, wherein the sealing surface includes a seal member configured to seal against the at least a portion of the header shield when the header shield is in the first position.

6. A plasmapheresis centrifuge bowl according to claim 5, wherein the seal member is configured to prevent non-sterile air from entering the interior of the plasmapheresis centrifuge bowl when sealed against the header assembly and when the actuating seal mechanism is in the closed mode.

7. A plasmapheresis centrifuge bowl according to claim 5, wherein the seal member is an O-ring and / or a gasket.

8. A plasmapheresis centrifuge bowl according to claim 2, wherein the first position of the header shield is a lowered state and the second position of the header shield is a raised state.

9. A plasmapheresis centrifuge bowl according to claim 2, wherein the actuating seal mechanism includes a sealing surface located on the header shield, at least a portion of the seal crown contacting the sealing surface when the header shield is in the first position such that the actuating seal mechanism is in the closed state.

10. A plasmapheresis centrifuge bowl according to claim 9, wherein the at least a portion of the seal crown does not contact the sealing surface when the header shield is in the second position such that the actuating seal mechanism in in the open state.

11. A plasmapheresis centrifuge bowl according to claim 9, wherein the sealing surface includes a seal member configured to seal against the at least a portion of the seal crown when the header shield is in the first position.

12. A plasmapheresis centrifuge bowl according to claim 1, further comprising a fluid path extending at least partially through a header shield of the plasmapheresis centrifuge bowl, the fluid path being open when the actuating seal mechanism is in the open state.

13. A plasmapheresis centrifuge bowl according to claim 12, wherein the fluid path is tortuous.

14. A plasmapheresis centrifuge bowl according to claim 12, further comprising: a filter located within the fluid path and configured to allow air to flow through the fluid path and prevent particulates from entering and / or exiting the interior of the plasmapheresis centrifuge bowl.

15. A plasmapheresis centrifuge bowl according to claim 1, further comprising at least one impeller located on a seal crown of the plasmapheresis centrifuge bowl and configured to facilitate airflow away from the interior of the plasmapheresis centrifuge bowl.

16. A plasmapheresis centrifuge bowl according to claim 15, wherein the at least one impeller includes a plurality of fan blades.

17. A plasmapheresis centrifuge bowl according to claim 16, wherein the plurality of fan blades are curved.

18. A plasmapheresis centrifuge bowl according to claim 1, further comprising: a seal crown secured to the neck portion of the plasmapheresis centrifuge bowl and configured to rotate with the plasmapheresis centrifuge bowl; anda header shield secured to a header assembly of the plasmapheresis centrifuge bowl.

19. A plasmapheresis centrifuge bowl according to claim 18, further comprising: a biasing member located within the header shield and configured to bias the actuating seal mechanism toward the closed position.

20. A plasmapheresis centrifuge bowl according to claim 19, wherein the actuating seal mechanism further includes a lifting member located within the header shield, the lifting member configured to interact with an actuating means to transition the actuating seal mechanism between the open state and the closed state.

21. An actuating seal for a plasmapheresis centrifuge bowl comprising:a seal crown secured to a neck portion of the plasmapheresis centrifuge bowl and configured to rotate with the plasmapheresis centrifuge bowl;a header shield secured to a header assembly of the plasmapheresis centrifuge bowland configured to move relative to the seal crown between a first position and a second position, the actuating seal configured to seal an interior of the plasmapheresis centrifuge bowl when the header shield is in the first position.

22. An actuating seal for a plasmapheresis centrifuge bowl according to claim 21, further comprising:a sealing surface located on the seal crown, at least a portion of the header shield contacting the sealing surface when in the first position.

23. An actuating seal for a plasmapheresis centrifuge bowl according to claim 22, wherein the at least a portion of the header shield does not contact the sealing surface when in the second position.

24. An actuating seal for a plasmapheresis centrifuge bowl according to claim 22, wherein the sealing surface includes a seal member configured to seal against the at least a portion of the header shield when the header shield is in the first position.

25. An actuating seal for a plasmapheresis centrifuge bowl according to claim 24, wherein the seal member is configured to prevent non-sterile air from entering the interior of the plasmapheresis centrifuge bowl when sealed against the header shield.

26. An actuating seal for a plasmapheresis centrifuge bowl according to claim 24, wherein the seal member is an O-ring and / or a gasket.

27. An actuating seal for a plasmapheresis centrifuge bowl according to claim 21, further comprising a fluid path extending at least partially through the header shield, the fluid path allowing air to exit the interior of the plasmapheresis centrifuge bowl during filling of the plasmapheresis centrifuge bowl and when the header shield is in the second position.

28. An actuating seal for a plasmapheresis centrifuge bowl according to claim 27, wherein the fluid path is tortuous.

29. An actuating seal for a plasmapheresis centrifuge bowl according to claim 27, further comprising:a filter located within the fluid path and configured to allow air to flow through the fluid path and prevent particulates from entering the interior of the plasmapheresis centrifuge bowl.

30. An actuating seal for a plasmapheresis centrifuge bowl according to claim 21, further comprising:a sealing surface located on the header shield, at least a portion of the seal crown contacting the sealing surface when the header shield is in the first position.

31. An actuating seal for a plasmapheresis centrifuge bowl according to claim 30, wherein the at least a portion of the seal crown does not contact the sealing surface when the header shield is in the second position.

32. An actuating seal for a plasmapheresis centrifuge bowl according to claim 30, wherein the sealing surface includes a seal member configured to seal against the at least a portion of the seal crown when the header shield is in the first position.

33. An actuating seal for a plasmapheresis centrifuge bowl comprising:a seal crown secured to a neck portion of the plasmapheresis centrifuge bowl and configured to rotate with the plasmapheresis centrifuge bowl;a header shield secured to a header assembly of the plasmapheresis centrifuge bowl; anda lifting member located within the header shield, the lifting member configured transition between a first position and a second position, the actuating seal configured to seal an interior of the plasmapheresis centrifuge bowl when the lifting member is in the first position.

34. An actuating seal for a plasmapheresis centrifuge bowl according to claim 33, further comprising:a sealing surface located on the seal crown, at least a portion of the lifting member contacting the sealing surface when in the first position.

35. An actuating seal for a plasmapheresis centrifuge bowl according to claim 34, wherein the at least a portion of the lifting member does not contact the sealing surface when in the second position.

36. An actuating seal for a plasmapheresis centrifuge bowl according to claim 34, wherein the sealing surface includes a seal member configured to seal against the at least a portion of the lifting member when the lifting member is in the first position.

37. An actuating seal for a plasmapheresis centrifuge bowl according to claim 36, wherein the seal member is configured to prevent non-sterile air from entering the interior of the plasmapheresis centrifuge bowl when sealed against the lifting member.

38. An actuating seal for a plasmapheresis centrifuge bowl according to claim 36, wherein the seal member is an O-ring and / or a gasket.

39. An actuating seal for a plasmapheresis centrifuge bowl according to claim 33, further comprising a fluid path extending at least partially through the header shield, the fluid path allowing air to exit the interior of the plasmapheresis centrifuge bowl during filling of the plasmapheresis centrifuge bowl and when the lifting member is in the second position.

40. An actuating seal for a plasmapheresis centrifuge bowl according to claim 39, wherein the fluid path is tortuous.

41. An actuating seal for a plasmapheresis centrifuge bowl according to claim 39, further comprising:a filter located within the fluid path and configured to allow air to flow through the fluid path and prevent particulates from entering and / or exiting the interior of the plasmapheresis centrifuge bowl.

42. An actuating seal for a plasmapheresis centrifuge bowl according to claim 33, further comprising:a biasing member located within the header shield and configured to bias the lifting member toward the first position.

43. An actuating seal for a plasmapheresis centrifuge bowl according to claim 33, wherein the lifting member is configured to interact with an actuating means to transition the lifting member from the first position toward the second position.

44. An actuating seal for a plasmapheresis centrifuge bowl according to claim 33, wherein the first position is a lowered position and the second position is a raised position.

45. An actuating seal for a plasmapheresis centrifuge bowl according to claim 33, further comprising at least one impeller located on the seal crown and configured to facilitate airflow away from the interior of the plasmapheresis centrifuge bowl.

46. An actuating seal for a plasmapheresis centrifuge bowl according to claim 45, wherein the at least one impeller includes a plurality of fan blades.

47. An actuating seal for a plasmapheresis centrifuge bowl according to claim 46, wherein the plurality of fan blades are curved.

48. An actuating seal for a plasmapheresis centrifuge bowl according to claim 33, further comprising:a sealing surface located on the lifting member, at least a portion of the seal crown contacting the sealing surface when the lifting member is in the first position.

49. An actuating seal for a plasmapheresis centrifuge bowl according to claim 48, wherein the at least a portion of the seal crown does not contact the sealing surface when the lifting member is in the second position.

50. An actuating seal for a plasmapheresis centrifuge bowl according to claim 49, wherein the sealing surface includes a seal member configured to seal against the at least a portion of the seal crown when the lifting member is in the first position.

51. An apheresis device comprising:a plasmapheresis centrifuge bowl, the plasmapheresis centrifuge bowl having: an outer body rotatable about a longitudinal axis of the plasmapheresiscentrifuge bowl, the outer body having a main body defining an interior, a neck portion extending proximal to the main body, and a shoulder connecting the main body and the neck portion,a separation region located within the interior, rotation of the plasmapheresis centrifuge bowl separating whole blood within the separation region into a first blood component and a second blood component,an inlet port for introducing whole blood into the plasmapheresis centrifuge bowl, andan actuating seal mechanism configured to transition between an open state when the plasmapheresis centrifuge bowl is rotating and a closed state when the plasmapheresis centrifuge bowl is not rotating; andan actuation mechanism configured to transition the actuating seal mechanism between the open state and the closed state.

52. An apheresis device according to claim 51, wherein the actuation mechanism includes a lifting arm configured to translate between a lowered position and a raised position and interact with a lifter on the actuating seal mechanism to transition the actuating seal mechanism between the open state and the closed state.

53. An apheresis device according to claim 52, wherein the lifting arm includes a strike plate configured to translate with the lifting arm.

54. An apheresis device according to claim 53, further comprising:a plurality of electromagnets configured to generate an electromagnetic force to lift the lifting arm and the strike plate to transition the actuating seal mechanism from the closed state toward the open state.

55. An apheresis device according to claim 54, wherein the lifting arm is configured to transition toward the lowered position upon removal of the electromagnetic force to transition the actuating seal mechanism from the open state toward the closed state.

56. An apheresis device according to claim 52, wherein the actuation mechanism includes at least one guide rod, the lifting arm translating along the guide rod when translating between the lowered position and the raised position.

57. An apheresis device according to claim 56, wherein the actuation mechanism includes at least one spring surrounding the at least one guide rod, the at least one spring configured to bias the lifting arm toward the lowered position.

58. An apheresis device according to claim 52, further comprising a detection mechanism configured to detect a position of the lifting arm.

59. An apheresis device according to claim 58, wherein the detection mechanism includes a sensor configured to emit light towards the lifting arm, the lifting arm having a reflective surface configured to reflect the emitted light back towards the sensor when the lifting arm is in the lowered position.

60. An apheresis device according to claim 58, wherein the detection mechanism includes a first conductive pin and a second conductive pin located on a lid of the apheresis device, the lifting arm having at least one tab configured to electrically connect the first and second conductive pins when the lifter arm is in the raised position.

61. An apheresis device according to claim 51, wherein the actuating seal mechanism includes a secondary seal configured to bias the actuating seal mechanism towards the closed state.

62. An apheresis device according to claim 51, wherein the plasmapheresis centrifuge bowl includes an alignment feature configured to interact with a second alignment feature located on a lid of the apheresis device to align the plasmapheresis centrifuge bowl with the actuation mechanism.

63. An apheresis device according to claim 51, wherein the actuation mechanism includes:at least one lifting bar positioned below a lifter on the actuating seal mechanism and configured to move between a lowered position and a raised position to transition the actuating seal mechanism from the closed state to an open state; andan actuator configured to raise the lifting bar to move the lifting bar from the lowered position to the raised position, thereby transitioning the actuating seal mechanism toward the open state.

64. An apheresis device according to claim 51, wherein the actuation mechanism is located below the plasmapheresis centrifuge bowl.

65. An apheresis device according to claim 64, wherein the actuation mechanism includes an electromagnetic actuator configured to move the plasmapheresis centrifuge bowl from a lowered position to a raised position, the actuating seal mechanism being in the closed mode when the plasmapheresis centrifuge bowl is in the raised position.

66. An apheresis device according to claim 65, wherein the plasmapheresis centrifuge bowl is located within a chuck of the apheresis device, the actuation mechanism located below at least a portion of the chuck such that the electromagnetic actuator moves the chuck and the plasmapheresis centrifuge bowl from the lowered position to the raised position.

67. An apheresis device according to claim 64, wherein the plasmapheresis centrifuge bowl is located within a chuck of the apheresis device, the actuation mechanism having a threaded gear mechanism configured to move the chuck and the plasmapheresis centrifuge bowl from a lowered position to a raised position, the actuating seal mechanism being in the closed mode when the plasmapheresis centrifuge bowl is in the raised position.

68. An apheresis device according to claim 51, wherein the actuation mechanism includes: an arm member located on a lid of the apheresis device; andan actuator configured to raise and lower the arm member and at least a portion of the lid, thereby transitioning the actuating seal mechanism between the closed state and the open state.

69. An apheresis device according to claim 68, wherein raising the arm member and the at least a portion of the lid transitions the actuating seal mechanism from the closed state toward the open state and lowering the arm member and the at least a portion of the lid transitions the actuating seal mechanism from the open state toward the closed state.

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