Fluid control and bypass functions for apheresis systems

Abstract

The pump for a fluid includes a rotor subassembly, a tube pressurizing block, an inlet guide, an outlet guide, and a tube guard. The rotor subassembly includes at least one roller. The tube pressurizing block includes a raceway and at least one protrusion. The tube pressurizing block is movable between a first position and a second position. The inlet guide has an inlet channel and is disposed proximate a first side of the tube pressurizing block. The outlet guide has an outlet channel and is disposed proximate a second side of the tube pressurizing block. The tube guard is configured to engage the inlet guide and the outlet guide when the tube guard is in a closed position and to expose the rotor subassembly, the tube pressurizing block, the inlet guide, and the outlet guide when the tube guard is in an open position.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 18 / 116,527, filed March 2, 2023, which claims the benefit of U.S. Provisional Patent Application No. 63 / 317,489, filed March 7, 2022, and U.S. Provisional Patent Application No. 63 / 318,735, filed March 10, 2022. The entire disclosures of the above applications are incorporated herein by reference.

[0002] The present disclosure relates generally to fluid control and bypass functions, and more particularly to fluid control and bypass functions in apheresis systems.

[0003] The present disclosure relates generally to the separation of components from multi-component fluids, and more particularly to apheresis methods and systems. [Background technology]

[0004] There are two commonly known methods for donating / collecting blood. The first method is whole blood donation from a donor, followed by a centrifugation process that separates blood components from the whole blood based on their density. The desired components can be transferred to a collection container manually, semi-automatically, or automatically while the whole blood is under the influence of the force generated by the centrifuge, or in some cases afterwards. The other method is apheresis collection, which requires specialized equipment. Summary of the Invention [Problem to be solved by the invention]

[0005] In the apheresis method, whole blood is extracted from a donor while the donor is connected to a dedicated device. The whole blood can be centrifuged to collect only the desired blood components (e.g., plasma), and all other undesired blood components can be returned to the donor during donation. The donor remains connected to the apheresis device during the separation and collection of blood components. The apheresis process has the disadvantage of being time-consuming and uncomfortable. In many cases, the donor must remain connected to the device for an hour to donate blood components. Therefore, making the blood donation procedure more efficient is currently desired at apheresis collection sites.

[0006] There is a need for a plasma or other blood component system that can shorten donation time and increase donor comfort. The embodiments provided herein can increase the efficiency of the blood collection process by using separated blood components to push or move undesired blood components back to the donor without stopping and restarting the centrifuge. Thus, the embodiments herein make the blood collection process more efficient and faster for the donor. [Means for solving the problem]

[0007] Embodiments may provide methods and devices for positioning a portion of a disposable (e.g., a loop) within a medical device. Embodiments may involve the use of a surface to automatically guide the loop. In at least one exemplary embodiment, the medical device may be a blood separation device, such as an apheresis device.

[0008] The needs mentioned above and others are addressed by various aspects, embodiments, and / or configurations, and while the present disclosure is given in terms of exemplary embodiments, it should be understood that individual aspects of the disclosure can be separately claimed.

[0009] In at least one exemplary embodiment, a pump for a fluid is described. The pump includes a rotor subassembly, a tube pressurizing block, an inlet guide, an outlet guide, and a tube guard. The rotor subassembly has at least one roller. The tube pressurizing block has a raceway and at least one protrusion. The tube pressurizing block is movable between a first position and a second position. The inlet guide has an inlet channel and is positioned proximate a first side of the tube pressurizing block. The outlet guide has an outlet channel and is positioned proximate a second side of the tube pressurizing block. The second side of the tube pressurizing block is opposite the first side of the tube pressurizing block such that a substantially linear path is formed between the inlet guide and the outlet guide. The tube guard is configured to engage the inlet guide and the outlet guide when the tube guard is in a closed position and to expose the rotor subassembly, the tube pressurizing block, the inlet guide, and the outlet guide when the tube guard is in an open position.

[0010] In at least one exemplary embodiment, the raceway may be curved and configured to contact an arc of the rotor subassembly when the tube pressurizing block is in the first position.

[0011] In at least one exemplary embodiment, the pump may be configured to engage a portion of the tubing. The portion of the tubing may be disposed through the inlet guide, the raceway, and the outlet guide. In at least one exemplary embodiment, the portion of the tubing may be configured to be partially occluded when the tube pressurizing block is in the second position. In at least one exemplary embodiment, the at least one protrusion and the at least one roller may be configured to engage with the portion of the tubing to partially occlude the tubing when the tube pressurizing block is in the second position. In at least one exemplary embodiment, the tube guard may include at least one channel protrusion configured to engage with at least one of the inlet channel or the outlet channel when the tube guard is in the closed position. In at least one exemplary embodiment, the at least one channel protrusion may be configured to engage with the portion of the tubing to partially occlude the portion of the tubing when the tube guard is in the closed position. In at least one exemplary embodiment, the at least one channel protrusion may comprise a first channel protrusion configured to engage with the inlet channel and a second channel protrusion configured to engage with the outlet channel. In at least one exemplary embodiment, the portion of the tubing may be configured to stretch when the pump is operating. The raceway may comprise at least one sidewall feature configured to collect the stretched portion of the portion of the tubing.

[0012] In at least one exemplary embodiment, the pump may further include at least one sensor disposed proximate to at least one of the inlet guide, the outlet guide, or the tube pressurization block. In at least one exemplary embodiment, the at least one sensor may be at least one of a pressure sensor, a line sensor, a cover position sensor, a movable block position sensor, an inductive sensor, an optical sensor, a light sensor, an ultrasonic sensor, or an air or fluid sensor.

[0013] In at least one exemplary embodiment, the tube pressurizing block may further include a cavity containing at least one biasing member configured to maintain the tube pressurizing block in at least one of the first position or the second position. In at least one exemplary embodiment, the at least one biasing member may be at least one spring. In at least one exemplary embodiment, the tube pressurizing block may further include at least one driven movement member disposed within the cavity. The at least one driven movement member may be configured to overcome a force of the at least one biasing member. In at least one exemplary embodiment, the at least one driven movement member may be a pneumatic diaphragm. The pneumatic diaphragm may be configured to expand to move the tube pressurizing block away from the first position to the second position. In at least one exemplary embodiment, the pump may be a normally closed pump, the first position being a closed position and the second position being an open position, the at least one biasing member being configured to maintain the tube pressurizing block in the first position, and the at least one driven operating member being configured to overcome the force of the at least one biasing member to move the tube pressurizing block to the second position. In at least one exemplary embodiment, the pump may be a normally open pump, the first position being a closed position and the second position being an open position, the at least one biasing member being configured to maintain the tube pressurizing block in the second position, and the at least one driven operating member being configured to overcome the force of the at least one biasing member to move the tube pressurizing block to the first position. In at least one exemplary embodiment, the pump may be an anticoagulant pump, and the first position may be a closed position.In at least one exemplary embodiment, the tube pressurizing block may be configured to move from the first position to the second position when an external force is applied to the tube pressurizing block.

[0014] In at least one exemplary embodiment, the pump may further include a fluid ingress prevention feature configured to collect fluid and prevent fluid from contacting at least one internal pump component.

[0015] Also described herein is a method for fluid control in a pump. The method includes inserting a tube into the pump via an inlet guide and an outlet guide. The pump may be in an open state when the tube is inserted with a tube pressurizing block in a first position. The method further includes closing the pump by moving the tube pressurizing block to a second position. The tube may be completely blocked between at least one roller of a rotor subassembly and a raceway of the tube pressurizing block when the tube pressurizing block is in the second position. The method further includes operating the pump by rotating the at least one roller to move fluid in the tube in a direction corresponding to the rotation of the roller.

[0016] In at least one exemplary embodiment, the pump may include a tube guard configured to engage the inlet guide and the outlet guide. In at least one exemplary embodiment, the tubing may be disposed between the tube guard and the inlet guide and between the tube guard and the outlet guide when the pump is in a closed state. In at least one exemplary embodiment, the tubing may be clamped in a diamond shape when disposed between the tube guard and the inlet guide and between the tube guard and the outlet guide.

[0017] In at least one exemplary embodiment, the tube may be configured to expand when the pump is operating, and the inlet guide and the outlet guide may have at least one notch configured to accommodate the expanded tube when the pump is operating.

[0018] Also described herein is a method of fluid control through an apheresis system. The method includes activating a first pump to draw whole blood from a donor, receiving whole blood from the donor within the apheresis system via an inlet tube fluidly connected to the apheresis system, moving the whole blood through the first pump of the apheresis system, stopping the first pump, and activating a second pump to move at least one component of the whole blood to a collection component of the apheresis system. In at least one exemplary embodiment, activating the second pump includes transitioning the second pump from an open state to a closed state. In at least one exemplary embodiment, activation of the second pump transitions the first pump from a closed state to an open state.

[0019] In at least one exemplary embodiment, the apheresis system may include a third pump configured to be in a closed state while the apheresis system is operating.

[0020] Embodiments include a method for collecting blood components by apheresis, the method including the steps of drawing whole blood from a donor into a centrifuge; rotating the centrifuge to apply centrifugal force to the whole blood and separate the whole blood into at least a first blood component and red blood cells; separating the first blood component from the whole blood; extracting the first blood component into a container; detecting that a second blood component has been extracted; and, after the second blood component is detected, pushing the separated first blood component back into the centrifuge while the centrifuge continues to rotate, and removing at least the red blood cells from the centrifuge and returning them to the donor.

[0021] In some embodiments of the above methods, the first blood component is one or more of plasma, platelets, red blood cells, and / or high hematocrit blood. In some embodiments of the above methods, the second blood component is one or more of plasma, platelets, red blood cells, and / or high hematocrit blood. In some embodiments of the above methods, the first blood component is two or more of plasma, platelets, red blood cells, and / or high hematocrit blood. In some embodiments of the above methods, the centrifuge rotates at a first speed when separating the first blood component from the whole blood. In some embodiments of the above methods, the centrifuge continues to rotate at the first speed when returning the separated first blood component to the centrifuge. In some embodiments of the above methods, the centrifuge rotates at a second speed when drawing whole blood from the donor into the centrifuge. In some embodiments of the above methods, the second speed is slower than the first speed. In some embodiments of the above method, the first blood component is separated from whole blood in a blood component collection set inserted into a centrifuge. In some embodiments of the above method, the centrifuge includes a filler that rotates a blood component collection bladder associated with the blood component collection set. In some embodiments of the above method, the blood component collection bladder is inserted into and held in a collection insert channel formed in the filler.

[0022] An embodiment includes an apheresis system including a needle inserted into a donor's blood vessel to draw whole blood from the donor; a first tube having a lumen and fluidly associated with the needle, the first tube moving the whole blood through the lumen; a draw pump engaged with the first tube to draw the whole blood from the donor into a centrifuge; a centrifuge that rotates to apply centrifugal force to the whole blood to separate the whole blood into at least a first blood component and red blood cells; a blood component collection bladder inserted into the centrifuge, fluidly associated with the first tube, and separating the first blood component from the whole blood; and a blood component collection bladder fluidly associated with the blood component collection bladder. a second tube connected to the centrifuge and configured to transfer the first blood component from the blood component collection bladder; a collection bottle fluidly associated with the second tube and configured to extract the first blood component from the apheresis system; a sensor positioned in physical proximity to the second tube and configured to detect that the second blood component is being extracted from the whole blood; and a return pump engaged with the second tube and configured to, after the second blood component is detected by the sensor, return the separated first blood component through the second tube to the blood component collection bladder and transfer at least red blood cells from the blood component collection bladder and return them to the donor while the centrifuge continues to rotate.

[0023] In some embodiments of the apheresis system, the first blood component is plasma and the second blood component is platelets, red blood cells, and / or high hematocrit blood. Some embodiments of the apheresis system further include an anticoagulant pump for drawing an anticoagulant from an anticoagulant bag and mixing the anticoagulant with the whole blood at a manifold or junction fluidly associated with the first tubing. In some embodiments of the apheresis system, the centrifuge includes a filler that rotates the blood component collection bladder. In some embodiments of the apheresis system, the blood component collection bladder is inserted into and held in a collection insert channel formed in the filler.

[0024] An embodiment includes a blood component collection set associated with an apheresis system, the blood component collection set including: a needle inserted into a blood vessel of a donor to draw whole blood from the donor; a first tube having a lumen and fluidly associated with the needle and moving the whole blood through the lumen, wherein a draw pump engaged with the first tube draws the whole blood from the donor; a blood component collection bladder inserted into a centrifuge and fluidly associated with the first tube, for separating the first blood component from the whole blood; and a blood component collection pump fluidly associated with the blood component collection bladder and for separating the first blood component from the whole blood. a second tube for transferring the first blood component from the bladder; and a collection bottle fluidly associated with the second tube for extracting the first blood component from the apheresis system, wherein a sensor is positioned in physical proximity to the second tube for detecting that the second blood component is being extracted from the whole blood, and after the second blood component is detected by the sensor, a return pump engaged with the second tube returns the separated first blood component to the blood component collection bladder through the second tube and transfers at least red blood cells from the blood component collection bladder for return to the donor while the centrifuge continues to rotate.

[0025] In some embodiments of the blood component collection set, the first blood component is plasma and the second blood component is platelets. In some embodiments of the blood component collection set, the draw pump is disengaged when the return pump returns the separated first blood component through the second tube to the blood component collection bladder to displace at least red blood cells from the blood component collection bladder and return them to the donor. In some embodiments of the blood component collection set, the blood component collection bladder is inserted and held in a filler that rotates the blood component collection bladder in a centrifuge. In some embodiments of the blood component collection set, the blood component collection bladder is inserted into a collection insert channel formed in the filler to hold the blood component collection bladder.

[0026] In some embodiments of the above method, when fluid is drawn from the donor on the next draw, a portion of the fluid previously delivered to the donor through the direct flow lumen is retained in the drip chamber as whole blood again passes through the fluid flow bypass pathway when red blood cells are returned to the donor.

[0027] An embodiment includes a pump for one or more of a biological fluid, a medical fluid, or an intravenous fluid, the pump including a base member, a rotor subassembly having at least one roller and disposed in support connection with the base member, the rotor subassembly having a partial arc that is operably engaged by being disposed to operably engage a portion of a tube, and a movable pressure block having a race surface and at least one protrusion, the at least one protrusion engaging and partially deforming but not fully occluding a portion of the tube adjacent the rotor, the movable pressure block configured to move to engage and disengage the at least one protrusion and the race surface to move the at least one protrusion and the race surface into and out of operative alignment with the rotor subassembly and the at least one roller in the partial arc of the rotor subassembly. the movable pressure block; an inlet guide member and an outlet guide member, the inlet guide member having an inlet channel formed therein and the outlet guide member having an outlet channel formed therein, the inlet guide member and the outlet guide member being disposed on opposite sides of the movable pressure block, the inlet channel and the outlet channel forming a generally linear shape for receiving the tubing portion in a generally linear manner; and a movable cover subassembly rotatably connected to the inlet and outlet guide members, the movable cover subassembly being operably disposed to cover a location where the arc of the race surface and the rotor subassembly and a portion of the inlet channel and a portion of the outlet channel adjacent to the arc of the race surface and the rotor subassembly operably engage, the movable cover subassembly having at least one channel protrusion that extends into a portion of one or the other of the inlet channel and the outlet channel and engages with the tubing portion adjacent the rotor to partially deform but not completely block the tubing portion.

[0028] In some embodiments above, the raceway is curved to match the arc shape of the rotor subassembly. In some embodiments above, except for the curved portion of the raceway where the raceway operably engages with the rotor subassembly and the arc of the rotor subassembly, the inlet channel, outlet channel, raceway, and rotor define a generally linear tube loading arrangement. In some embodiments above, at least one protrusion of the movable pressurizing block provides a tortuous fluid path within a tube portion engaged thereby. In some embodiments above, at least one protrusion of the movable cover member provides a tortuous fluid path within a tube portion engaged thereby. In some embodiments above, the at least one protrusion of the movable pressurizing block includes first and second protrusions, the first protrusion being defined adjacent to the inlet channel of the inlet guide member and the second protrusion being defined adjacent to the outlet channel of the outlet guide member, and both the first and second protrusions providing first and second tortuous fluid paths within a tube portion engaged thereby. In some embodiments above, the at least one protrusion of the movable cover member includes a first and a second protrusion, the first protrusion defined for operably inserting into the inlet channel of the inlet guide member and the second protrusion defined for operably inserting into the outlet channel of the outlet guide member, both of the first and second protrusions providing first and second tortuous fluid paths within the tube portion engaged thereby. In some embodiments above, the at least one protrusion of the movable cover member includes at least a third protrusion defined for operably inserting into one of the inlet channel of the inlet guide member and the outlet channel of the outlet guide member, the third protrusion providing a third tortuous fluid path within the tube portion engaged thereby. In some embodiments above, one of the inlet channel and the outlet channel has at least a first recess, the first recess defined to operably receive at least one protrusion of a movable cover member insertable into one of the inlet channel of the inlet guide member and the outlet channel of the outlet guide member, the first recess providing a tortuous fluid path within the tube portion engaged thereby.In some embodiments above, the inlet channel or the outlet channel has at least one or more of a second recess and a third recess, the second and third recesses being defined to operably receive at least one protrusion of a movable cover member insertable into one of the inlet channel of the inlet guide member and the outlet channel of the outlet guide member, the second and third recesses providing a tortuous fluid path within the tube segments engaged thereby. In some embodiments above, the at least one protrusion of at least one of the movable pressurizing block and the movable cover subassembly minimizes one or both of longitudinal movement of the tube segments in the inlet channel, outlet channel, or raceway and lateral movement of the tube segments in the inlet channel, outlet channel, or raceway.

[0029] Some of the above embodiments include a system further comprising at least one sensor disposed in or adjacent to one of the inlet channel, the outlet channel, or the movable pressurizing block raceway. Some of the above embodiments include at least one sensor disposed in or adjacent to one of the inlet channel or the outlet channel. In some of the above embodiments, the at least one sensor comprises two or more sensors. In some of the above embodiments, the at least one sensor is at least one of a pressure sensor, a line sensor, a cover position sensor, a movable block position sensor, an inductive sensor, an optical sensor, a light sensor, an ultrasonic sensor, or an air or fluid sensor. In some of the above embodiments, at least one protrusion on at least one of the movable pressurizing block and the movable cover subassembly minimizes movement of a tube segment relative to the at least one sensor.

[0030] An embodiment includes a method for minimizing movement of a tubing segment in a pump for one or more of a biological fluid, a medical fluid, or an intravenous fluid, the method including: engaging a portion of the tubing segment with at least one protrusion of at least one of a movable pressurizing block and a movable cover subassembly to minimize movement of the tubing segment in one of an inlet channel, an outlet channel, and a raceway; and reducing movement relative to one or both of a pump roller and a sensor.

[0031] In some embodiments, engaging includes one or more of compressing the tubing and partially occluding the tubing, thereby providing a tortuous fluid path within the engaged tubing segment. In some embodiments, reducing includes one or more of reducing tubing movement in a longitudinal direction, reducing tubing movement in a lateral direction, reducing movement to improve rotor and pump efficiency, and reducing movement to improve sensor operability. In some embodiments, the direction of reduction includes one or more of: longitudinal direction is along the length of one or more of the inlet channel, outlet channel, and raceway; longitudinal direction is along the length of the curved surface of the raceway; lateral direction is transverse to the length of the tubing segment; and lateral direction is transverse to the length of the tubing segment at a right angle or at an oblique or acute angle to the right angle.

[0032] Embodiments include a pump for one or more of a biological fluid, a medical fluid, or an intravenous fluid, the pump being one of a normally open or a normally closed type, the pump comprising: a base member; a rotor subassembly having at least one roller and disposed in support connection with the base member, the rotor subassembly having a partial arc that is operably engaged by being disposed to operably engage a portion of tubing; and a movable pressure block having a race surface disposed in contact with the rotor subassembly to completely occlude the portion of tubing adjacent the rotor, the movable pressure block being operable to engage and disengage the at least one protrusion and the race surface. The movable pressure block is movable to place at least one protrusion and race surface into or out of an operable position relative to the rotor subassembly and at least one roller in a partial arc of the rotor subassembly, and the movable pressure block has a cavity therein, and within the cavity are at least one biasing member disposed within the cavity to hold the movable pressure block in one of a normally open open position or a normally closed closed position, and a driven operating member operably disposed within the cavity to overcome the biasing member's retention and move the movable pressure block away from the normally open open position or the normally closed closed position to which it is biased.

[0033] In some embodiments above, the biasing member is at least one spring biasing toward one of the normally open position or the normally closed position. In some embodiments above, the driven operation member is a pneumatic diaphragm operably disposed within the cavity to expand and move the movable pressurizing block away from the normally open position or the normally closed position in a biased state. In some embodiments above, the movable block has a front inner wall defined within the cavity and disposed near the raceway surface, a rear inner wall defined within the cavity and disposed farther from the raceway surface than the front inner wall, and a support wall operably associated with and disposed within the movable block but not structurally connected to the movable block and not movable relative to the movement of the movable pressurizing block, the biasing member being disposed in engagement with the support wall and one or other of the front inner wall and the rear inner wall, and the driven operation member being disposed adjacent to and operatively engaged with one or other of the rear inner wall and the front inner wall in an opposing arrangement with the biasing member. In some aspects of the above, the movable block has a front inner wall defined within the cavity and positioned near the raceway surface, a rear inner wall defined within the cavity and positioned farther from the raceway surface than the front inner wall, and a support wall operatively associated with the movable block but not structurally connected to the movable block and not movable relative to the movement of the movable pressurizing block, the biasing member is disposed in engagement with the support wall and the front inner wall, the driven operation member is disposed adjacent to the rear inner wall in an opposing arrangement with respect to the biasing member and is operative to engage therewith, the biasing member exerting a normally closed position. In some aspects of the above, the driven operation member is operatively disposed within the cavity to move the movable pressurizing block in a direction away from a normally closed position in a biased state.In some aspects above, the movable block has a front inner wall defined within the cavity and positioned near the raceway surface, a rear inner wall defined within the cavity and positioned farther from the raceway surface than the front inner wall, and a support wall operatively associated with the movable block but not structurally connected to the movable block and not movable relative to the movement of the movable pressurizing block, the biasing member being positioned in engagement with the support wall and the rear inner wall, the driven operation member being positioned adjacent to the front inner wall in an opposing arrangement with respect to the biasing member and operative to engage therewith, the biasing member being in a normally open position. In some aspects above, the driven operation member is operatively positioned within the cavity to move the movable pressurizing block in a direction away from a normally open position in a biased state. In some aspects above, the driven operation member is operatively positioned within the cavity to move the movable pressurizing block in a direction away from a normally open position or a normally closed position in a biased state. In some embodiments, the driven operating member is a pneumatic diaphragm operably disposed within the cavity to expand and move the movable pressurizing block away from the normally open or normally closed position, and in some embodiments, the movable pressurizing block further includes at least one protrusion that engages and partially deforms but does not completely close a tube portion adjacent the rotor, and the movable pressurizing block is movable to engage and disengage the at least one protrusion and race surface to move the at least one protrusion and race surface into and out of an operable position relative to the rotor subassembly and at least one roller in a partial arc of the rotor subassembly.Some of the above aspects further include a movable cover subassembly rotatably connected to the inlet and outlet guide members, the movable cover subassembly operably arranged to cover a location where the race surface and the arc of the rotor subassembly and a portion of the inlet channel and a portion of the outlet channel adjacent to the arc of the race surface and the rotor subassembly operably engage, the movable cover subassembly having at least one channel protrusion that extends into a portion of one or the other of the inlet channel and the outlet channel and engages with a tube portion adjacent the rotor to partially deform but not completely block the tube portion. Some of the above aspects further include an inlet guide member and an outlet guide member, the inlet channel formed in the inlet guide member and the outlet channel formed in the outlet guide member, the inlet guide member and the outlet guide member being disposed on opposite sides of the movable pressurizing block, the inlet channel and the outlet channel forming a substantially linear shape for receiving the tube portion in a substantially linear manner.

[0034] Embodiments include a method of positioning a pump in one or other of a normally open or normally closed configuration, the method including the steps of: providing a movable pressurizing block for operably engaging a rotor subassembly having a partial arc in one or other of the normally open or normally closed configuration, the movable pressurizing block having an internal cavity and a race surface arranged to contact the rotor subassembly and completely block a tube section adjacent the rotor, the movable pressurizing block being movable to engage and disengage at least one protrusion and race surface to place and remove the at least one protrusion and race surface from an operative arrangement relative to the rotor subassembly and at least one roller in the partial arc of the rotor subassembly; biasing within the cavity to hold the movable pressurizing block in one of the normally open or normally closed position; and driving within the cavity to overcome the retention of a biasing member and move the movable pressurizing block from the biased normally open or normally closed position.

[0035] An embodiment includes a blood component collection set comprising a centrifuge for separating blood components from whole blood, and an inlet tube fluidly connected to the donor and the centrifuge, the centrifuge including a pump for one or more of a biological fluid, a medical fluid, or an intravenous fluid, the pump comprising a base member, a rotor subassembly having at least one roller and supported and disposed connected to the base member, the rotor subassembly having a partial arc that is operably engaged by being disposed to operably engage a portion of the inlet tube, and a movable pressurizing block having a race surface and at least one protrusion, the at least one protrusion engaging a portion of the inlet tube adjacent the rotor to partially deform but completely displace the portion. a movable pressure block that does not fully close, the movable pressure block being configured to move to engage and disengage the at least one protrusion and race surface to place and remove the at least one protrusion and race surface from an operable position relative to the rotor subassembly and at least one roller in a partial arc of the rotor subassembly; and an inlet guide member and an outlet guide member, the inlet guide member forming an inlet channel and the outlet guide member forming an outlet channel, the inlet guide member and the outlet guide member being positioned on opposite sides of the movable pressure block, the inlet channel and the outlet channel forming a generally linear shape for receiving the tube portion in a generally linear manner.

[0036] An embodiment includes a blood component collection set comprising a centrifuge for separating blood components from whole blood and an inlet tube fluidly connected to the donor and the centrifuge, the centrifuge including a pump for one or more of a biological fluid, a medical fluid, or an intravenous fluid, the pump being one of a normally open or a normally closed type, the pump comprising: a base member; a rotor subassembly having at least one roller and disposed in support relation to the base member, the rotor subassembly having a partial arc that is operably engaged by being disposed to operably engage a portion of a tubing; and a movable pressure block having a race surface disposed to contact the rotor subassembly to completely occlude the portion of the tubing adjacent the rotor. The movable pressure block is movable to engage and disengage the at least one protrusion and race surface to place and remove the at least one protrusion and race surface in an operable position relative to the rotor subassembly and at least one roller in a partial arc of the rotor subassembly, and the movable pressure block has a cavity therein, and within the cavity are at least one biasing member disposed within the cavity to hold the movable pressure block in one of a normally open open position or a normally closed closed position, and a driven operating member operably disposed within the cavity to overcome the biasing member's retention and move the movable pressure block away from the normally open open position or the normally closed closed position to which it is biased.

[0037] Some of the above aspects include an inlet tube fluidly connected to the donor and the pump, the inlet tube being operably associated with the movable pressurizing block and operably loadable within the pump.Some of the above aspects include a blood component collection set, the blood component collection set including an inlet tube fluidly connected to the donor and the pump, the inlet tube being operably associated with the movable pressurizing block and operably loadable within the pump.

[0038] Some aspects described above include a method of moving fluids through an apheresis system, the method including: providing a pump for drawing whole blood from a donor; receiving whole blood from the donor within the apheresis system via an inlet tube fluidly connected to the apheresis system; moving the whole blood through a draw pump of a centrifuge in the apheresis system, the draw pump being normally closed and having one or both of a movable pressurizing block having at least one protrusion and a movable cover subassembly having at least one cover protrusion; and moving components to a collection section using a return pump, the return pump being normally open and having one or both of a movable pressurizing block having at least one protrusion and a movable cover subassembly having at least one cover protrusion.

[0039] In some embodiments, a normally closed anticoagulant pump is further provided. In some embodiments, the pump is part of a blood component collection set. In some embodiments, the blood component collection set is part of an apheresis system.

[0040] An embodiment includes an apheresis system including a needle inserted into a donor's blood vessel to draw whole blood from the donor; a first tube having a lumen and fluidly associated with the needle for moving the whole blood through the lumen; a draw pump engaged with the first tube for drawing the whole blood from the donor into a centrifuge; a centrifuge configured to rotate to apply centrifugal force to the whole blood to separate the whole blood into at least a first blood component and red blood cells; a blood component collection bladder inserted into the centrifuge and fluidly associated with the first tube for separating the first blood component from the whole blood; a second tube fluidly associated with the blood component collection bladder for moving the first blood component from the blood component collection bladder; and a blood pump configured to remove the first blood component from the apheresis system. a collection bottle for extracting the first blood component from the whole blood; a sensor located in physical proximity to the second tube for detecting that the second blood component has been extracted from the whole blood; and a return pump engaged with the second tube for returning the separated first blood component to the blood component collection bladder through the second tube and moving at least red blood cells from the blood component collection bladder to return them to the donor while the centrifuge continues to rotate after the second blood component has been detected by the sensor, wherein the return pump is normally closed and has one or both of a movable pressurizing block having at least one protrusion and a movable cover subassembly having at least one cover protrusion, and the return pump is normally open and has one or both of a movable pressurizing block having at least one protrusion and a movable cover subassembly having at least one cover protrusion. In some embodiments of the apheresis system described above, the first blood component is plasma, and the second blood component is platelets, red blood cells, and / or high-hematocrit blood. In some embodiments, the apheresis system further comprises an anticoagulant pump for drawing anticoagulant from an anticoagulant bag and mixing the anticoagulant with the whole blood at a manifold or junction fluidly associated with the first tubing.

[0041] An embodiment includes a blood component collection set associated with an apheresis system, the blood component collection set comprising: a needle inserted into a donor's blood vessel to draw whole blood from the donor; a first tube having a lumen and fluidly associated with the needle and moving the whole blood through the lumen, wherein a draw pump engaged with the first tube draws the whole blood from the donor; a blood component collection bladder inserted into a centrifuge and fluidly associated with the first tube to separate the first blood component from the whole blood; a second tube fluidly associated with the blood component collection bladder and moving the first blood component from the blood component collection bladder; and a collection bottle fluidly associated with the second tube and for extracting the first blood component from the apheresis system; A sensor is positioned physically proximate to the second tube to detect that a second blood component has been extracted from the whole blood, and after the second blood component is detected by the sensor, a return pump engaged with the second tube returns the separated first blood component to the blood component collection bladder through the second tube and moves at least red blood cells from the blood component collection bladder and returns them to the donor while the centrifuge continues to rotate, the draw pump being normally closed and having one or both of a movable pressurizing block having at least one protrusion and a movable cover subassembly having at least one cover protrusion, and the return pump being normally open and having one or both of a movable pressurizing block having at least one protrusion and a movable cover subassembly having at least one cover protrusion. In some embodiments described above, the first blood component is plasma, and the second blood component is platelets, red blood cells, and / or high hematocrit blood. In some embodiments, the blood component collection set further includes an anticoagulant pump for drawing an anticoagulant from the anticoagulant bag and mixing the anticoagulant with the whole blood at a manifold or junction fluidly associated with the first tubing. In some embodiments, the draw pump is disengaged when the return pump returns the separated first blood component to the blood component collection bladder through the second tubing and displaces at least red blood cells from the blood component collection bladder for return to the donor.In some embodiments described above, the blood component collection set is part of an apheresis system.

[0042] An embodiment includes a pump for a fluid comprising: a base member; an inlet guide member and an outlet guide member, the inlet guide member defining an inlet channel and the outlet guide member defining an outlet channel, the inlet guide member and the outlet guide member being disposed on the base member, the inlet channel and the outlet channel forming a generally linear shape for receiving a tubing portion in a generally linear manner; and a movable cover subassembly rotatably connected to the inlet and outlet guide members, the movable cover subassembly being operably disposed to cover a portion of the inlet channel and a portion of the outlet channel, the movable cover subassembly having at least one channel protrusion that extends into a portion of one or the other of the inlet and outlet channels and engages a tubing portion adjacent the rotor to partially deform but not completely occlude the tubing portion.

[0043] In some embodiments above, at least one protrusion of the movable pressure block provides a tortuous fluid path within the tube portion engaged thereby.

[0044] In some embodiments above, the at least one protrusion of the movable cover member provides a tortuous fluid path within the tube portion engaged thereby.

[0045] In some embodiments above, the at least one protrusion of the movable cover member includes at least first and second protrusions, the first protrusion being defined for operably insertion into the inlet channel of the inlet guide member and the second protrusion being defined for operably insertion into the outlet channel of the outlet guide member, both of the first and second protrusions providing first and second tortuous fluid paths within a tube segment engaged thereby. In some embodiments above, the first and second protrusions have V-shaped surfaces configured to receive the tube segment engaged thereby. In some embodiments above, the V-shaped surfaces comprise chamfered edges. In some embodiments above, one of the inlet and outlet channels has at least a first recess defining a valley, and the first recess, first protrusion, and second protrusion impart a diamond-shaped interior to the tube segment engaging the first recess, first protrusion, and second protrusion. In some embodiments above, one of the inlet channel and the outlet channel has at least a first recess, the first recess defined to operably receive at least one protrusion of a movable cover member insertable into one of the inlet channel of the inlet guide member and the outlet channel of the outlet guide member, the first recess providing a tortuous fluid path within the tube segments engaged thereby. In some embodiments above, the inlet channel or the outlet channel has at least one or more of a second recess and a third recess, the second and third recesses defined to operably receive at least one protrusion of a movable cover member insertable into one of the inlet channel of the inlet guide member and the outlet channel of the outlet guide member, the second and third recesses providing a tortuous fluid path within the tube segments engaged thereby. In some embodiments above, the at least one protrusion of at least one of the movable cover subassemblies is configured to minimize at least one of longitudinal movement of the tube segments in the inlet channel, the outlet channel, or the raceway and lateral movement of the tube segments in the inlet channel, the outlet channel, or the raceway.

[0046] Any one or more of the aspects / embodiments substantially as disclosed herein.

[0047] Any one or more of the above aspects / embodiments substantially as disclosed herein may optionally be combined with any one or more of the other aspects / embodiments substantially as disclosed herein.

[0048] One or more means adapted to carry out any one or more of said aspects / embodiments substantially as disclosed herein.

[0049] The present disclosure can provide many advantages depending on the particular aspect, embodiment, and / or configuration. By maintaining the centrifuge rotation speed while transferring unwanted blood components back to the donor, the apheresis procedure time can be reduced, in some cases by 30%. This increased efficiency allows for faster and more comfortable donor donations. With faster donor donation times, donor donation centers can obtain more donor donations in a typical day, increasing productivity and revenue. Furthermore, with faster donor donation times, donors are more likely to return for another donor donation. With faster donor donation times, donor donation centers can also attract donors who use other donor donation centers with slower donor donation times.

[0050] These and other advantages will be apparent from the present disclosure.

[0051] The terms "at least one," "one or more," and "and / or" are open-ended expressions that are both conjunctive and disjunctive in operation. For example, the phrases "at least one of A, B, and C," "at least one of A, B, or C," "one or more of A, B, and C," "one or more of A, B, or C," and "A, B, and / or C" each mean A only, B only, C only, both A and B, both A and C, both B and C, or all of A, B, and C.

[0052] The term "a" or "an" entity refers to one or more of that entity. Thus, the terms "a" (or "an"), "one or more" (one or more), and "at least one" can be used interchangeably herein. It should also be noted that the terms "comprising," "including," and "having" can be used interchangeably.

[0053] As used herein, the term "donor" can refer to anyone who provides a fluid, such as whole blood, to an apheresis system. A donor can also be a patient who temporarily provides a fluid to an apheresis system, where the fluid is processed, treated, manipulated, etc., before being returned to the patient.

[0054] As used herein, the term "automatic" and variations thereof refer to any process or operation that occurs without substantial human input when the process or operation is performed. However, a process or operation may be automatic even if significant or non-significant human input is used in the execution of the process or operation, if the input is accepted before the process or operation is performed. Human input is considered significant if it affects how the process or operation is performed. Human input that implies consent to the execution of a process or operation is not considered "critical."

[0055] As used herein, the term "computer-readable medium" refers to any tangible storage and / or transmission medium that participates in providing instructions to a processor for execution. Such media may take many forms, including, but not limited to, nonvolatile media, volatile media, and transmission media. Nonvolatile media include, for example, NVRAM or magnetic or optical disks. Volatile media include dynamic memory such as main memory. Common forms of computer-readable media include, for example, floppy disks, flexible disks, hard disks, magnetic tape, or any other magnetic media, magneto-optical media, CD-ROMs, any other optical media, punch cards, paper tape, any other physical media with patterns of holes, RAM, PROMs, EPROMs, FLASH-EPROMs, solid-state media such as memory cards, any other memory chips or cartridges, carrier waves, or any other medium from which a computer can read. A digital file attachment to an email or other self-contained information archive or set of archives is considered a distribution medium equivalent to a tangible storage medium. When the computer-readable medium is configured as a database, it should be understood that the database may be any type of database, such as relational, hierarchical, object-oriented, and / or the like. Accordingly, the present disclosure is considered to encompass tangible storage or distribution media on which software implementations of the present disclosure are stored, and prior art-recognized equivalents and successor media.

[0056] As used herein, the term "module" refers to any known or later developed hardware, software, firmware, artificial intelligence, fuzzy logic, or combination of hardware and software that is capable of performing the functions associated with that element.

[0057] As used herein, the terms "determining," "calculating," and "computing," as well as variations thereof, are used interchangeably and include any type of methodology, process, mathematical operation, or technique.

[0058] It should be understood that the term "means" as used herein should be given its broadest possible interpretation pursuant to the sixth paragraph of 35 U.S.C. Section 112. Accordingly, any claim containing the term "means" is intended to cover all structure, material, or acts described herein, and all equivalents thereof. Furthermore, structure, material, or acts, and equivalents thereof, are intended to include everything described in the Summary, Brief Description of the Drawings, Detailed Description, Abstract, and the claims themselves.

[0059] The foregoing is a simplified summary of the present disclosure to provide an understanding of some aspects thereof. This summary is not an extensive or comprehensive overview of the present disclosure and its various aspects, embodiments, and / or configurations. It is not intended to identify key or critical elements of the disclosure, nor is it intended to delineate the scope of the disclosure; rather, it is intended to present selected concepts of the disclosure in a simplified form as a prelude to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and / or configurations of the present disclosure may be envisioned that utilize, alone or in combination, one or more of the features set forth above or described in detail below. [Brief explanation of the drawings]

[0060] [Figure 1] FIG. 1 is a perspective view of the operating environment of an apheresis system according to an embodiment of the present disclosure. [Figure 2A] FIG. 2A is a perspective view of the apheresis system shown in FIG. [Figure 2B] FIG. 2B is a first detailed perspective view of a pump of an apheresis system according to an embodiment of the present disclosure. [Figure 2C] FIG. 2C is a second detailed perspective view of a pump of an apheresis system according to an embodiment of the present disclosure. [Figure 2D] FIG. 2D is a perspective view of an embodiment of the present disclosure. [Figure 2E]FIG. 2E is a perspective view of an embodiment of the present disclosure. [Figure 2F] FIG. 2F is an elevation view of an embodiment of the present disclosure. [Figure 2G] FIG. 2G is an elevation view of an embodiment of the present disclosure. [Figure 2H] FIG. 2H is an elevation view of an embodiment of the present disclosure. [Figure 2I-1] FIG. 2I-1 is an elevation view of an embodiment of the present disclosure. [Figure 2I-2] FIG. 2I-2 is a perspective view of an embodiment of the present disclosure. [Figure 2I-3] 2I-3 are cross-sectional views of embodiments of the present disclosure. [Figure 2I-4] 2I-4 are cross-sectional views of embodiments of the present disclosure. [Figure 2J] FIG. 2J is a perspective view of an embodiment of the present disclosure. [Figure 2K1] FIG. 2K1 is a plan view of an embodiment of the present disclosure. [Figure 2K2] FIG. 2K2 is a plan view of an embodiment of the present disclosure. [Figure 2L1] FIG. 2L1 is a plan view of an embodiment of the present disclosure. [Figure 2L2] FIG. 2L2 is a top view of an embodiment of the present disclosure. [Figure 2M1] FIG. 2M1 is a perspective view of an embodiment of the present disclosure. [Figure 2M2] FIG. 2M2 is a cross-sectional view of an embodiment of the present disclosure. [Figure 2M3] FIG. 2M3 is a perspective view of an embodiment of the present disclosure. [Figure 2M4] FIG. 2M4 is a cross-sectional view of an embodiment of the present disclosure. [Figure 2N] FIG. 2N is a perspective view of an embodiment of the present disclosure. [Figure 2O] FIG. 2O is a perspective view of an embodiment of the present disclosure. [Figure 2P1] FIG. 2P1 is a cross-sectional view of an embodiment of the present disclosure. [Figure 2P2] FIG. 2P2 is an exploded view of an embodiment of the present disclosure. [Figure 2Q1]FIG. 2Q1 is a schematic diagram of an embodiment of the present disclosure. [Figure 2Q2] FIG. 2Q2 is a schematic diagram of an embodiment of the present disclosure. [Figure 2R1] FIG. 2R1 is a schematic diagram of an embodiment of the present disclosure. [Figure 2R2] FIG. 2R2 is a schematic diagram of an embodiment of the present disclosure. [Figure 2S1] FIG. 2S1 is a perspective view of an embodiment of the present disclosure. [Figure 2S2] FIG. 2S2 is a plan view of an embodiment of the present disclosure. [Figure 2T1] FIG. 2T1 is a perspective view of an embodiment of the present disclosure. [Figure 2T2] FIG. 2T2 is a plan view of an embodiment of the present disclosure. [Figure 2T3] FIG. 2T3 is a perspective view of an embodiment of the present disclosure. [Figure 2U] FIG. 2U is a detailed perspective view of a fluid valve control system according to an embodiment of the present disclosure. [Figure 3] FIG. 3 is a flow chart of a method for fluid control in a pump. [Figure 4] FIG. 4 is a flow chart of a method of fluid control through an apheresis system. DETAILED DESCRIPTION OF THE INVENTION

[0061] In the accompanying figures, similar components and / or features may have the same reference label. Furthermore, various components of the same type may be distinguished by following the reference label with a letter that distinguishes between the similar components. When only a first reference label is used in the specification, the description can apply to any one of the similar components having the same first reference label regardless of the second reference label.

[0062] Embodiments of the present disclosure are described in the context of apheresis methods and systems. The following embodiments are described with respect to separating blood components from whole blood. However, this is provided for illustrative purposes only. It should be noted that the embodiments are not limited to the following description. The embodiments are intended for use in products, processes, devices, and systems for pumping fluids. For example, the embodiments disclosed herein may be used to separate any complex liquid. Thus, the present disclosure is not limited to separating blood components from whole blood.

[0063] FIG. 1 illustrates a perspective view of an operating environment 100 of an apheresis system 200 according to at least one exemplary embodiment of the present disclosure. The operating environment 100 includes an apheresis system 200, a donor 102, and one or more connections (e.g., donor supply tubing 104, cassette inlet tubing 108A, anticoagulant tubing 110, etc.) extending from the donor 102 to the apheresis system 200 and / or vice versa. As shown in FIG. 1 , the donor supply tubing 104 is fluidly connected to at least one blood vessel, e.g., a vein, of the donor 102 via venipuncture. For example, a cannula connected to the end of the donor supply tubing 104 is inserted through the skin of the donor 102 and into a target site, i.e., a vein. This connection provides a venous pathway for blood to flow from the donor 102 to the apheresis system 200 and / or for blood components to flow back to the donor 102. In at least one exemplary embodiment, the fluid pathways and connections may form an extracorporeal tubing circuit of the apheresis system 200.

[0064] Blood supplied from the donor 102 flows along donor supply tubing 104, through tubing connector 106, and along cassette inlet tubing 108A into soft cassette assembly 300. Soft cassette assembly 300 may include one or more fluid control paths and valves for selectively controlling the flow of blood to and / or from donor 102. Apheresis system 200 may include an anticoagulant supply contained in anticoagulant (AC) bag 114. Anticoagulant is pumped through at least anticoagulant tubing 110 and tubing connector 106 to prevent clotting of blood within apheresis system 200.

[0065] The anticoagulant may include, but is not limited to, one or more of citrate and / or unfractionated heparin. The AC bag 114 and other bags or bottles described herein may be formed from, for example, but not limited to, one or more of polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene with vinyl acetate (EVA), rubber, silicone, thermoplastic, thermoplastic elastomer, polymer, copolymer, and / or combinations thereof. The amount of AC in the AC bag 114 may vary based on various factors, including the mass of the donor 102, the volumetric flow rate of blood from the donor, etc. In one example, the volume in the AC bag 114 is 250-500 mL, although the volume in the AC bag 114 may be greater or less than this volume.

[0066] In at least one exemplary embodiment, the apheresis system 200 may include a plasma collection bottle 122 or container, saline fluid contained in a saline bag 118, and one or more lines or tubing (e.g., fluid transfer tubing, etc.) (such as saline tubing 116 and plasma tubing 120) connecting the saline bag 118 and the plasma collection bottle 122 to the extracorporeal tubing circuit of the apheresis system 200. The amount of saline provided in the saline bag 118 is between 500 and 800 mL, although the volume within the saline bag 118 may be greater or less than this volume. An example blood collection volume for a blood component (e.g., plasma) may be 880 mL. Thus, the plasma collection bottle 122 can hold at least this amount of plasma. In at least one exemplary embodiment, the plasma collection bottle 122 may include a connection point located at, adjacent to, or in physical proximity to the approximate bottom-most portion of the plasma collection bottle 122 (e.g., when the plasma collection bottle 122 is placed in the plasma collection cradle 232C, as shown in FIG. 2A ). The connection point may include one or more connectors configured to interconnect with the plasma tubing 120 to receive and / or transport plasma. Locating the connection point at the bottom of the plasma collection bottle 122 allows plasma contained within the plasma collection bottle 122 to travel back out of the plasma tubing 120 through a line, as described herein, without trapping air bubbles, etc. In at least one exemplary embodiment, the plasma collection bottle 122 may be configured as a flexible bag, a rigid container, and / or other container, and thus, the plasma collection bottle 122 is not limited to a bottle or bottle-like container.

[0067] FIG. 2A shows a perspective view of the apheresis system 200 depicted in FIG. 1 . The apheresis system 200 enables a continuous whole blood separation process. In at least one exemplary embodiment, whole blood is drawn from a donor 102 and substantially continuously fed to a blood component separation device of the apheresis system 200. In the blood component separation device, the blood is separated into various components, and at least one of these blood components is collected from the apheresis system 200. In at least one exemplary embodiment, one or more of the separated blood components may be collected for subsequent use or returned to the donor 102. Blood is drawn from the donor 102 and directed to a centrifuge of the apheresis system 200 through an opening 220 in an access panel 224 of the apheresis system 200. In at least one exemplary embodiment, the donor supply tubing 104, cassette inlet tubing 108A, inlet tubing 108B, outlet tubing 112, saline tubing 116, and plasma tubing 120 used in the extracorporeal tubing circuit collectively comprise a closed, sterile, disposable system or blood component collection set, described further below.

[0068] Examples of apheresis systems, plasmapheresis systems, and other separation systems that may be used with embodiments of the present disclosure, such as apheresis system 200, include, but are not limited to, the SPECTRA OPTIA® apheresis system, the COBE® Spectra apheresis system, and the TRIMA ACCEL® automated blood collection system (these systems are manufactured by Terumo BCT, located in Lakewood, Colorado).

[0069] The operation of the various pumps, valves, and blood component separation device or centrifuge may be controlled by one or more processors included in apheresis system 200, and is preferably controlled by multiple embedded computer processors that are part of a computer system. The computer system may include components that allow a user to interface with the computer system, including, for example, memory and storage (RAM, ROM (e.g., CD-ROM, DVD), magnetic drives, optical drives, flash memory, etc.), communication / networking devices (e.g., wired, such as a modem / network card, or wireless, such as WiFi), input devices such as a keyboard, touchscreen, camera, and / or microphone, and output devices such as a display and audio system. To assist an operator of apheresis system 200 with various aspects of its operation, in at least one exemplary embodiment, the blood component separation device or centrifuge may include a graphical user interface with a display that includes an interactive touchscreen.

[0070] Apheresis system 200 may include a housing 204 and / or structural frame, a cover 210, an access panel 224 disposed on the front 202 and / or rear 206 of apheresis system 200, and one or more supports 232A-232C, which may include hooks, rests, cradles, arms, protrusions, plates, and / or other support features for holding, resting, and / or supporting a container or AC bag 114, a saline bag 118, or a plasma collection bottle 122. In at least one exemplary embodiment, the features of apheresis system 200 are described relative to coordinate system 103 and / or one or more axes thereof. Housing 204 may include an apparatus frame (e.g., formed from welded, bolted, and / or connected structural elements, extrusions, beams, etc.) to which one or more panels, such as cover 210, base member 210A (see, e.g., FIGS. 2D-2T3), doors, subassemblies, and / or components, are attached. In at least one exemplary embodiment, at least one panel of apheresis system 200 can include mounting surfaces for soft cassette assembly 300, a first normally-closed pneumatic pump such as draw pump 208, a second normally-closed pneumatic pump such as return pump 212, a normally-open pump such as AC pump 216, and / or a fluid valve control system such as fluid valve control system 228 (e.g., plasma / saline valve control, etc.).

[0071] Access panel 224 may include one or more handles, locks, and pivots or hinges 226 (e.g., door hinges, piano hinges, continuous hinges, clean room hinges, etc.). In any event, access panel 224 is selectively opened to provide access to the interior of apheresis system 200, and more specifically, the blood separation assembly or centrifuge. In at least one exemplary embodiment, access panel 224 provides access to the interior for installing and / or removing one or more components of a blood component collection set from the centrifuge.

[0072] The interior of apheresis system 200 may be divided into at least a centrifuge section and a control section. For example, the centrifuge section includes a cavity configured to receive a centrifuge, a spinning motor, and associated hardware. This area may be physically separated from the control section by one or more walls of the cavity. In at least one exemplary embodiment, access to the control section (e.g., configured to house or include a motor controller, a CPU or processor, electronics, wiring, etc.) may be provided through a rigidly fastened panel of housing 204 and / or a panel separate from access panel 224.

[0073] In at least one exemplary embodiment, apheresis system 200 includes at least one of a draw pump 208, a return pump 212, or an AC pump 216 configured to control the flow of fluids (e.g., blood and / or blood components, anticoagulant, saline, etc.) to, through, or away from apheresis system 200, as shown in more detail in FIGS. 2A-2U. For example, as shown generally in FIG. 2A, apheresis system 200 includes a draw pump 208 that controls the flow of blood from donor 102 to a centrifuge of apheresis system 200 and / or from the centrifuge to donor 102. The draw pump 208 may engage a portion of inlet tubing 108B that is disposed between soft cassette assembly 300 and the centrifuge of apheresis system 200. In at least one exemplary embodiment, apheresis system 200 includes a return pump 212 configured to control the flow of separated blood components (e.g., plasma, etc.) from the centrifuge to plasma collection bottle 122 and / or vice versa via tubing segments such as outlet tubing 112 and / or plasma tubing 120. Additionally or alternatively, return pump 212 may control the flow of saline (e.g., supplied from saline bag 118 via tubing segments such as saline tubing 116 and / or outlet tubing 112) throughout the blood component collection set and / or apheresis system 200. AC pump 216 may engage a portion of anticoagulant tubing 110 to selectively control the flow of anticoagulant to inlet tubing 104 / 108A throughout the blood component collection set of apheresis system 200.As shown in FIG. 2A, draw pump 208, return pump 212, or AC pump 216 may be at least partially disposed on top of cover 210 of apheresis system 200, or may be connected to base member 210A, base member 210A', or base member 210A'', as shown in FIGS. 2D-2T3, for otherwise attaching to components or members operatively associated with cover 210 or housing 204 or apheresis system 200 and / or within the apheresis system, among others.

[0074] 2B, 2C, 2D, and 2E show various perspective views of the draw pump 208, the return pump 212, or the AC pump 216 of the apheresis system 200, according to at least one exemplary embodiment of the present disclosure. While the draw pump 208, the return pump 212, and the AC pump 216 are described herein in connection with an apheresis system, it should be understood that they are not limited to use within an apheresis system. While the draw pump 208 is most particularly shown and described with reference to FIGS. 2B-2M4, it should be understood that the other pump assemblies of the apheresis system 200, i.e., the return pump 212 and the AC pump 216, may differ in some details and operate differently. However, in many cases, the return pump 212 and / or the AC pump 216 may be substantially similar in construction, if not identical, to the described draw pump 208, or may include similar structural parts. For purposes of explanation, the draw pump 208 will be described first, followed by differences and other details of the return pump 212 and AC pump 216. Elevation views of an exemplary draw pump 208 are shown in Figures 2F, 2G, 2H, and 2I-1, another perspective view is shown in Figure 2J, followed by four plan views in Figures 2K1, 2K2, 2L1, and 2L2. Various details will be described below and may be shown in some figures but not others.

[0075] As shown in some of FIGS. 2B-2J, the draw pump 208 may include a pump cover 236 or housing configured to at least partially house the moving elements of the draw pump 208. In at least one exemplary embodiment, the draw pump 208 may include a hinged tube guard door subassembly or tube guard 240 configured to open and close about a tube guard pivot axis 242. In at least one exemplary embodiment (not shown herein), the tube guard 240 may be attached to the pump cover 236 via one or more fasteners disposed along the tube guard pivot axis 242, or, as shown in other embodiments such as FIGS. 2D and 2K1, the guard 240 may be connected to respective guides, such as inlet guide 244 and outlet guide 252, via rotary connections 237A, 237B, among others. The door or tube guard 240 also restrains the tubing for sensors to reduce or prevent tubing movement. 2B and 2C, blood supplied by donor 102 may be delivered or drawn into the centrifuge by draw pump 208 in a first draw or centrifuge direction 250A. Additionally or alternatively, blood or other fluids may be delivered or drawn into donor 102 by draw pump 208 in a donor direction 250B opposite centrifuge direction 250A.

[0076] In at least one exemplary embodiment, the draw pump 208 and / or return pump 212, AC pump 216 may be a tube pump, peristaltic pump, diaphragm pump, and / or other pump configured to manipulate the flow of fluid (e.g., air, blood, blood components, anticoagulant, saline, etc.) within at least a portion of a tube. For example, the draw pump 208, return pump 212, or AC pump 216 may include a motor operatively interconnected with a rotating tube contact assembly. In operation, tubes (e.g., inlet tube 108B, outlet tube 112, anticoagulant tube 110, etc.) may be inserted into the inlet guide 244, tube pressurization block 248, and outlet guide 252 adjacent to the rotating tube contact head or rotor subassembly 261 (see FIGS. 2C and 2K1). In at least one exemplary embodiment, the tube pressurizing block 248 may be moved away from the rotating tube contacting head of the draw pump 208, return pump 212, or AC pump 216 to provide a mounting clearance area and / or to occlude or unocclude the tube as desired, or vice versa. The rotating tube contacting head or rotor subassembly 261 (see particularly FIGS. 2C and 2K1 ) includes a plurality of rotating pressure rollers 268, each configured to rotate about a respective pressure roller rotation axis 264 ( FIG. 2C ). Each of the rotating pressure rollers 268 may be disposed between a first rotating plate 272A and a second rotating plate 272B of the rotor subassembly 261, as shown in FIG. 2C , where the first rotating plate 272A and the second rotating plate 272B may be configured to rotate about the pump rotation axis 260 to maintain the rotating pressure roller 268 at a desired Z-direction height. In at least one exemplary embodiment, the first rotating plate 272A and the second rotating plate 272B are first and second ends of the rotor subassembly 261, in which case the first rotating plate 272A and the second rotating plate 272B are functional parts of the rotor subassembly 261.In at least one exemplary embodiment, the rotating pressure roller 268 may be positioned at or near the periphery of the first rotating plate 272A and the second rotating plate 272B.

[0077] One or more of the draw pump 208, return pump 212, and AC pump 216 may include or operate similarly to, without limitation, a Pulsafeeder® Model UX-74130 peristaltic pump, a Pulsafeeder® MEC-O-MATIC series pump, all manufactured by Pulsafeeder Inc. of Punta Gorda, Florida. Other examples of the draw pump 208, return pump 212, and AC pump 216 include, but are not limited to, an INTEGRA DOSE IT laboratory peristaltic pump manufactured by INTEGRA Biosciences AG of Switzerland, and a WELCO WP1200, WP1100, WP1000, WPX1, and / or WPM series peristaltic pump, all manufactured by WELCO Co., Ltd. of Tokyo, Japan.

[0078] 2C, 2L1, and / or 2L2, when a tube is loaded into the leading portion or inlet guide 244, particularly the tube pressurizing block 248, and / or the trailing portion or outlet or outlet guide 252, at least some of the rotating pressurizing rollers 268 of the rotor subassembly 261 engage, contact, or otherwise pressurize the tube disposed between the rotor subassembly 261 and the tube pressurizing block 248. As the rotor subassembly 161, including the first rotating plate 272A and the second rotating plate 272B, rotates about the pump rotation axis 260, the rotating pressurizing rollers 268 press against the tube segment between the rotor subassembly 261 of the draw pump 208, the return pump 212, or the AC pump 216 and the tube pressurizing block 248, and the movement of the rotating pressurizing rollers 268 ensures that the fluid inside the tube segment moves in a particular direction, such as the centrifuge direction 250A or the donor direction 250B. For example, when rotor subassembly 261 rotates counterclockwise about pump axis of rotation 260, the rotation of rotating pressure roller 268 pressing against the tube between rotating pressure roller 268 and tube pressurizing block 248 can move or pump fluid in centrifuge direction 250A. As another example, when rotor subassembly 261 rotates clockwise about pump axis of rotation 260, the rotation of rotating pressure roller 268 pressing against the tube between rotating pressure roller 268 and tube pressurizing block 248 can move or pump fluid in donor direction 250B.

[0079] In at least one exemplary embodiment, when the drawing pump 208 is in a closed state and the tubing is disposed between the rotor subassembly 261 and the tube pressurizing block 248, at least one of the rotating pressure rollers 268 engages the tubing to completely occlude it. As the rotor subassembly 261 rotates, the rotating pressure roller 268 moves relative to the tube pressurizing block 248, as described above. As shown in FIG. 2K1 , the rotor subassembly 261 may be designed with seven rotating pressure rollers. This may ensure that when the drawing pump 208 is in a closed state, the section of tubing between the rotor subassembly 261 and the tube pressurizing block 248 is completely occluded the entire time the rotor subassembly 261 is rotating. For example, when one of the rotating pressure rollers 268 disengages the section of tubing near the outlet guide 252, the rotating pressure roller near the inlet guide 244 engages the tubing to maintain the other section of tubing completely occluded. In other embodiments, the rotor subassembly 162 may be designed with more or fewer rotating pressure rollers 268 so that the portion of the tubing between the rotor subassembly 261 and the tubing pressure block 248 is completely blocked when the draw pump 208 is in the closed state.

[0080] When not actively pumping, the draw pump 208 is maintained in a state where at least one rotating pressure roller 268 continues to occlude the inlet tube 108B (normally closed, or NC) or where the rotating pressure roller 268 does not occlude the inlet tube 108B (normally open, or NO). Thus, the draw pump 208 can also act as a "valve" that either prohibits fluid movement (NC) or allows fluid movement (NO) based on its state when not in operation. One or other of these valve functions can be used in one or more of the draw pump 208, the return pump 212, or the AC pump 216. For example, when the apheresis system 200 is operating, if the draw pump 208 is in a closed state, the return pump 212 can be in an open state. Similarly, if the return pump 212 is in a closed state, the draw pump can be in an open state.

[0081] Tube guard 240 and pump cover 236 serve to protect an operator (e.g., a phlebotomist, an apheresis technician, etc.) and / or donor 102 from accidental contact with one or more moving parts of draw pump 208, return pump 212, and AC pump 216. In at least one exemplary embodiment, tube guard 240 may be retained in a closed position via one or more guard closure features 254 (see FIG. 2C ) or hooks 245A, 245B, 245C, or 245D (see, in particular, FIGS. 2D-2J, 2S1, and / or 2T1 ) disposed on or in operative association with tube guard 240, inlet guide 244, tube pressurization block 248, and / or outlet guide 252. These guard closing features 254 may be magnets ( FIG. 2C ) or springs housed in the tube guard 240, the leading or inlet guide 244, the tube pressurizing block 248, and / or the trailing or outlet guide 252. In at least one exemplary embodiment, the draw pump 208, the return pump 212, and the AC pump 216 may be stopped or prevented from moving / operating when the tube guard 240 is open. In this embodiment, door closure sensors 255B (e.g., FIG. 2K2) and / or 255B′ ( FIG. 2S2) may be included in one or more of the guard closing feature 254, the inlet guide 244 ( FIG. 2K2), and the outlet guide 252 (for 255B′ in FIG. 2S2), and / or the tube pressurizing block 248.

[0082] In at least one exemplary embodiment, some further and / or alternative pump details may be as follows. For example, in FIGS. 2D-2J , exemplary suction pump 208 is shown with exemplary door or tube guard 240, which covers a portion of the tubing (not shown in FIGS. 2D-2J ) relative to inlet guide 244 and outlet guide 252, as well as tubing pressurizing block 248 and rotor subassembly 261 (located beneath pump cover 236). Door or tube guard 240 is shown herein, among other things, to include a latch hook subsystem. In particular, latch bar 241 is shown as being provided as part of and / or connected to tube cover or tube guard 240. In these examples, latch bar 241 is pivotable relative to tube guard 240 at and / or about axis 243.

[0083] 2E, 2F, 2G, 2H, and 2I-1 illustrate an exemplary opening process of tube guard 240 relative to inlet guide 244, outlet guide 252, and tube pressurizing block 248. Starting from the closed position shown in FIGS. 2D and 2F, it can be seen that in this closed position, hook 245A on or connected to latch bar 241 is initially engaged with hook 245B of inlet guide 244. Similarly, in FIG. 2E, hooks 245C and 245D are shown as associated with outlet guide 252. In FIG. 2G, latch bar 241 is shown being rotated, here in a counterclockwise direction, but not by way of limitation, to disengage hooks 245A and 245B from one another. This rotation is about axis 243. The door or tube guard 240 can then be rotated, again in a non-limiting counterclockwise direction, about the tube guard pivot axis 242 as shown in FIG. 2H (see also, e.g., FIG. 2E) to a substantially open position as shown in FIGS. 2I-1 and 2J. This rotation of the tube guard 240 is accomplished via rotational connections 237A and 237B to the inlet guide 244 and the outlet guide 252, respectively, as shown in FIG. 2D. When a tube is loaded, rotating both the tube guard 240 and the latch bar 241 in opposite directions closes the tube guard 240 against the tube, tube guide, pressure block, and rotor subassembly. The latch bar 241 may be spring-loaded, for example, to bias it toward the non-rotated position of FIGS. 2F and 2H, 2I-1, and 2J after the external force applied in FIG. 2G is removed. In at least one exemplary embodiment, hook 245A may be manually engaged by an operator to disengage hook 245A from mating hook 245B. To re-engage hook 245A with mating hook 245B, the operator presses down on tube guard 240. When force is applied to tube guard 240, tube guard 240 rotates about tube guard pivot axis 242 and hook 245A hooks onto mating hook 245B such that tube guard 240 is in a closed position as shown in FIGS. 2D and 2F.

[0084] In loading tubing into the pump, beginning with FIG. 2E and continuing through various stages shown in FIGS. 2F-2M2, channels such as inlet channel 247 and outlet channel 257 corresponding to inlet guide 244 and outlet guide 252 receive tubing, and as shown in more detail in FIGS. 2L1 and 2L2, a section of tubing, such as inlet tube 108B, is received or placed in the channel in a generally linear or in-line arrangement. This is sometimes referred to as linear tubing loading. In at least one exemplary embodiment, linear tubing loading allows for the use of pump tubing or pump header tubing that is not different from the tubing used throughout the tubing set. Furthermore, several other structural and procedural features may make this embodiment suitable for the use of pump tubing or pump header tubing that is not different from the tubing used throughout the tubing set. More specifically, this embodiment does not require different tubing for the tubing section engaged within the rotor-race engagement region. Using a common type of tubing can result in lower manufacturing and component procurement costs. In previous systems, specially manufactured tubing was preferred or required for use in / with the pump due to the amount of plasticizer and tightly controlled tubing thickness required for adequate minimum operability and safety. In at least one exemplary embodiment, the tubing used herein may be manufactured from a material such as silicone or a different tubing polymer. Additionally, the embodiments described herein can increase the lifespan of the tubing. As described herein, the embodiments structurally and procedurally impart controlled forces to the tubing that vary based on the tubing itself, its relative thickness, and the amount of plasticizer.

[0085] As explained above and further below, inlet channel 247 and outlet channel 257 shown in Figures 2E and 2F are configured and adapted to receive inlet tube 108B (Figures 2L1 and 2L2). Additionally, tube guard 240 has protrusions 249A, 249B, and 249C (shown in Figures 2H, 2I-1, and 2J) that contact and engage inlet channel 247 and outlet channel 257 and at least partially contribute to holding inlet tube 108B in place.

[0086] 2I-2-2I-4, each of the protrusions 249A, 249B, and 249C of the tube guard 240 includes a shaped surface 251A, 251B, and 251C on the respective protrusions 249A, 249B, and 249C. The shaped surfaces 251A, 251B, and 251C assist in engaging the tube 108B. In at least one exemplary embodiment, the shaped surfaces 251A, 251B, and 251C may be relatively curved or may have an inverted V-shaped surface. In at least one exemplary embodiment, at least one of the shaped surfaces 251A, 251B, and 251C may include a V-shaped notch 251D. The protrusions 249A, 249B, and 249C, the shaped surfaces 251A, 251B, and 251C, and the V-shaped notch 251D (see FIGS. 2I-1 through 2I-4) are positioned to enter and rest within the recesses 253A, 253B, and 253C (see, for example, FIGS. 2K1 and 2K2) of the inlet guide 244 and the outlet guide 252, respectively. In at least one exemplary embodiment, the inlet block side portion 201A includes one protrusion 249 and the outlet block side portion 201B includes two protrusions 249. It will be understood that in other embodiments, the inlet block side portion 201A and the outlet block side portion 201B may include one protrusion, two protrusions, or more than two protrusions.

[0087] When tube guard 240 is closed against inlet guide 244 and outlet guide 252, protrusions 249A, 249B, and 249C having shaped surfaces 251A, 251B, and 251C enter respective recesses 253A, 253B, and 253C, engaging and pushing against tubing disposed therein without completely obstructing it. This engagement is partially obstructed so that fluid flow through inlet tube 108B is slightly affected. This may provide a tortuous path but does not completely obstruct inlet tube 108B. As shown in FIGS. 2I-3 , when tube guard 240 is closed against inlet guide 244 and outlet guide 252, inlet tube 108B may be clamped to manipulate it to have a generally diamond-shaped cross section. The engagement primarily provides a restraining and retention function to reduce or eliminate tubing movement within draw pump 208, particularly within the raceway / pump roller engagement region (described further below).

[0088] 2I-4, tube guard 240 may form an angle Θ with inlet guide 244 and outlet guide 252. Angle Θ in conjunction with downwardly sloping portion 231 serves to direct inlet tube 108B downward as it enters the draw pump 208 and guide inlet tube 108B into a portion of the draw pump 208 such that inlet tube 108B is positioned to be occluded by rotating pressure roller 268 in the draw pump 208.

[0089] For purposes of illustration, the suction pump 208 in Figures 2K1, 2K2, 2L1, and 2L2 is shown without the pump cover 236 and tube guard 240. When the suction pump 208 is shown without the pump cover 236, the rotor subassembly 261 having a plurality of rotating pressure rollers 268 is exposed. Also shown for clarity, particularly in Figures 2K1 and 2K2, are the races or raceways 246, inlet channel 247, and outlet channel 257, and associated recesses 253A, 253B, and 253C. Also shown in more detail is the tube pressure block 248, which in this and other embodiments is movable in both directions 259 inward and outward relative to the rotor subassembly 261. This movement is further described below.

[0090] In some embodiments, inlet channel 247, outlet channel 257, inlet guide 244, tube pressurizing block 248, and outlet guide 252 are shown in FIGS. 2K1 and 2K2 to include several key sensors. Pressure sensor 255A is partially shown in outlet guide 252 and outlet channel 257. In some exemplary embodiments, pressure sensor 255A may be a centrifuge pressure sensor (i.e., CPS) that engages the tubing in outlet channel 257 and can measure or determine the pressure of the fluid therein, here blood, which is in pressure communication with the downstream fluid in the centrifuge, thereby determining relative centrifuge pressure. Also shown in FIG. 2K2 are door closure sensor 255B and one or two moving block position sensors 255C and 255D. Door closure sensor 255B is located in inlet guide 244, here operably positioned near hook 245B to sense closure of tube guard 240. Door closure sensor 255B may be an inductive sensor or other sensor. One or both of moving block position sensors 255C and / or 255D, as used herein, are below tube pressurizing block 248 and may sense the closing of tube pressurizing block 248 relative to rotor subassembly 261 (moving block position sensor 255D) or the open positioning of tube pressurizing block 248 relative to rotor subassembly 261 (moving block position sensor 255C). One or both of moving block position sensors 255C and / or 255D may be employed, and in some embodiments, may be optical sensors that are triggered by the movement / positioning of tube pressurizing block 248.

[0091] The tube pressurizing block 248 can further include a curved surface of the raceway 246 disposed between the first protruding portion 256A and the second protruding portion 256B. The first protruding portion 256A and the second protruding portion 256B can be an overall transition zone of the raceway 246 configured to guide the inlet tube 108B from the inlet guide 244 to the curved surface of the raceway 246 and into the outlet guide 252.

[0092] The raceway 246 is positioned to be in substantial operative engagement with the rotating pressure rollers 268. This operative engagement is achieved by moving the tube pressure block 248 in direction 259, alternately moving the raceway into and out of engagement with the rotating pressure rollers 268 of the rotor subassembly 261. When engaged with the rotor subassembly 261, the portion of the inlet tube 108B that is occluded by at least one of the rotating pressure rollers 268 is positioned between the curved surface of the raceway 246 and the rotor subassembly 261. In at least one exemplary embodiment, the raceway 246 provides a hard stop plate that allows at least one of the rotating pressure rollers 268 to pinch or occlude the inlet tube 108B against the surface of the raceway 246. In at least one exemplary embodiment, the rolling of the rollers moves the occlusion in one direction or the other along the tube line, causing fluid within the tube to move with the moving occlusion. In at least one exemplary embodiment, rotor subassembly 261 is configured to rotate in both a clockwise and counterclockwise direction so that the occlusion moves in either direction along inlet tube 108B.

[0093] These functions and operations are illustrated, for example, in Figures 2L1 and 2L2. In Figure 2L1, tube pressurizing block 248 is shown either moving or having moved in outward direction 259A to slide raceway 246 open. In this position, there is sufficient space between rotating pressurizing roller 268 and the surface of raceway 246 to allow an unobstructed portion of inlet tube 108B to be positioned therebetween. In the figure, inlet tube 108B is also positioned within inlet channel 247 of inlet guide 244 and within outlet channel 257 of outlet guide 252. The substantially unobstructed positioning of inlet tube 108B in the placement of the tube in and / or between inlet guide 244, outlet guide 252, tube pressurizing block 248, and rotating pressurizing roller 268 is schematically illustrated, and an unobstructed thickness or unobstructed diameter dimension "d" is shown.

[0094] As shown (slightly exaggerated to illustrate the concept) in FIG. 2L2, movement of tube pressurizing block 248 in inward direction 259B causes raceway 246 to engage the tube, crushing it against roller 268A (some thickness of inlet tube 108B remains in the illustration, representing the thickness of the tube sidewall). In some exemplary embodiments, draw pump 208 may include sidewall features 258A, 258B that assist in maintaining placement of inlet tube 108B within draw pump 208 without normally restricting flow when inlet tube 108B is engaged with draw pump 208. Additionally, sidewall features 258A, 258B may function to gradually guide inlet tube 108B into raceway 246, thereby preventing a sudden pressure excursion when one of rotating pressurizing rollers 268 contacts raceway 246 and completely occludes inlet tube 108B. In at least one exemplary embodiment, the positioning of the inlet tube 108B creates a tortuous path for the fluid, which may further ensure that there is no movement within and / or within the tube.

[0095] Additionally, as described above, when protrusions 249A, 249B, and 249C (not shown in FIGS. 2L1 and 2L2) are lowered into and engaged with recesses 253A, 253B, and 253C with inlet tube 108B in inlet channel 247 and outlet channel 257, protrusions 249A, 249B, and 249C engage inlet tube 108B and compress the tube substantially laterally in a substantially non-occlusive manner. These are illustrated in FIG. 2L2 by slightly enlarged areas of the tube in each of recesses 253A, 253B, and 253C, each having a diameter greater than "d." These cooperate to hold the tube in a substantially fixed position for the sensor and for engagement with rotating pressure roller 268. Additionally, cooperation or cooperation of one or more of these tube retention features, such as inlet channel 247 and outlet channel 257, with recesses 253A, 253B, 253C and protrusions 249A, 249B, 249C and / or raceway 246 adjacent to rotating pressure roller 268 and / or tube pressure block 248, allows for straight-line loading of the tubes and allows the pump header portion of inlet tube 108B to be used as the same tube as any and / or all of the other tubes in line throughout the tubing set, thereby eliminating the need for specially developed tubing.

[0096] 2M1-2M4 show other views of the retraction pump 208. FIG. 2M1 is a cross-sectional view of the apheresis system 200 showing additional details of the inlet guide 244. In at least one exemplary embodiment, the inlet guide 244 may include a notch 244A configured to provide space for the tubing to tension, thereby preventing the tubing from buckling within the apheresis system 200. In at least one exemplary embodiment, the notch 244A may be a sidewall feature located at one or both ends of the raceway 246. For example, when the tubing is placed in the apheresis system 200, the tubing expands and contracts as a pump, such as the retraction pump 208, operates. As the inlet tubing 108B is stretched, its length increases, which tends to increase the likelihood of the tubing buckling. The notch 244A may be configured to allow the tubing to stretch by increasing the area over which the tubing rests, thereby preventing the tubing from buckling. Notch 244A can provide additional space for the tubing to expand and can allow for the use of common tubing throughout the apheresis system. As discussed above, using common tubing within apheresis system 200 can reduce costs associated with apheresis system 200.

[0097] In some exemplary embodiments, inlet guide 244 may additionally include a flared portion 244B configured to assist in maintaining a desired position of the tube within draw pump 208. For example, flared portion 244B may be configured to guide inlet tube 108B within raceway 246, which helps to retain the tube within raceway 246. It should be understood that features similar to notch 244A and flared portion 244B may also be included in outlet guide 252.

[0098] 2M2, there is shown the pivot shaft 233 of the rotor subassembly 261. In at least one exemplary embodiment, the pivot shaft may be located between a pair of rotating pressure rollers 268.

[0099] 2M3 and 2M4, a fluid ingress prevention feature of apheresis system 200 is shown. In at least one exemplary embodiment, the fluid ingress prevention feature may be a bank portion 267 surrounding access point 267A of retract pump 208 to internal pump components. In at least one exemplary embodiment, bank portion 267 may be a feature of base member 210A. Bank portion 267 may prevent fluid exiting any of the tubing through apheresis system 200 from reaching the pump's electrical components, such as retract pump 208, return pump 212, or the motor of AC pump 216. In at least one exemplary embodiment, bank portion 267 may be positioned at other locations in apheresis system 200 so as to be configured to capture fluid before it reaches any of the pump's electrical components.

[0100] 2N and 2O show two partially exploded views of the tube pressurizing block 248, which is interconnected with two other components: the outlet guide 252 in FIG. 2N and the inlet guide 244 in FIG. 2O. Here, two wing members 269A, 269B of the tube pressurizing block 248 are shown operably positioned within receiving slots 271A, 271B defined in the inlet guide 244 and the outlet guide 252, respectively. The receiving slots 271A, 271B are elongated in a lateral direction, which is the direction from the inside to the outside of the page. The lateral direction corresponds to direction 259 in FIG. 2K1. This allows for movement of the tube pressurizing block 248 in and out of the rotor subassembly 261 and relative to the inlet guide 244 and the outlet guide 252. This also prevents the tube pressurizing block 248 from moving in an undesired direction relative to the inlet guide 244 and outlet guide 252, particularly when moving back and forth relative to the rotor and when the rotor is engaged to press against the raceway 246 during pumping operation.

[0101] In at least one exemplary embodiment, a driving force can be used to control the movement of the tube pressurizing block 248. Referring to FIG. 2P1, a pneumatic / spring system 290 is shown. FIG. 2P1 is a cross-sectional view of the base member 210A and the tube pressurizing block 248 with the internal components of the spring system 290. Here, the spring system 290 is spring-loaded and pneumatic. The spring system 290 includes a diaphragm member 291, a pneumatic fitting 292A, and an air pressure source tube 292B. The diaphragm member 291 is disposed inside a cavity 293 defined within the tube pressurizing block 248. The pneumatic fitting 292A and the air pressure source tube 292B allow air and / or other gases or fluids to move therethrough to expand or contract the diaphragm. The spring system 290 further includes one or more compression springs 294 and a spring support structure 295. The spring support structure 295 may be proximate or adjacent to the diaphragm member in at least one exemplary embodiment. The one or more compression springs 294 and spring support structure 295 are shown in more detail in FIG. 2P2, an exploded view of the spring system 290 and tube pressurization block 248. In FIG. 2P2, the inlet guide 244 and outlet guide 252 are shown exploded to the side, above, and away from the tube pressurization block 248, and the spring system 290 is exploded below. The diaphragm member 291 is shown with three compression springs 294 and spring support structure 295 next to the pneumatic fitting 292A and the pneumatic source tube 292B. In other embodiments, fewer or more than three compression springs 294 may be provided.

[0102] Schematic diagrams of the diaphragm member 291, pneumatic coupling 292A, and one or more compression springs 294 are shown in FIGS. 2Q1 and 2Q2. In FIG. 2Q1, the spring system 290 is shown in cross section along with the base member 210A and the tube pressurizing block 248. The tube pressurizing block 248 now shows an upper lip portion 262 adjacent the surface of the raceway 246, which provides a ledge for holding the tube downward against the surface of the raceway 246 to maintain engagement with the rotating pressurizing roller 268. The internal components of the spring system 290 include the diaphragm member 291 and the pneumatic coupling 292A. The diaphragm member 291 is disposed within a cavity 293 defined within the tube pressurizing block 248. One or more compression springs 294 and a spring support structure 295 may also be disposed within the cavity 293. 2Q2, air and / or gas and / or fluid is then introduced as indicated by arrow 296A, expanding diaphragm member 291 and pushing against inner wall 293A, moving tube pressurizing block 248 to an open position away from rotor subassembly 261 (not shown in FIG. 2Q2) and compressing one or more compression springs 294. Distance "x" shown in FIG. 2Q2 represents the movement of tube pressurizing block 248 in direction 297.

[0103] Shown and described herein is a normally closed (NC) operation, in which the tube pressurizing block 248 is normally held in a fully engaged position, pushed forward toward the rotor subassembly 261, by one or more compression springs 294. In at least one exemplary embodiment, the fully engaged position is a position in which the face of the raceway 246 is positioned adjacent to the rollers, such that, when a tube is attached, it is fully pushed into a fully closed position. The one or more compression springs 294 maintain such a position regardless of whether power is applied to the system. When the apheresis system 200 commands the tube pressurizing block 248 to open, a pneumatic system is activated to provide a driving force to the diaphragm member 291, moving the tube pressurizing block 248 to the open position relative to the NC, i.e., normally closed, position. This embodiment is a desirable arrangement for a draw pump, such as draw pump 208, because it provides a fail-safe or check valve action to prevent the apheresis system 200 from attempting to withdraw or return more blood from a connected donor in the event of a power outage or accidental power interruption. When power is lost, the solenoid valve directing pressurized air to diaphragm member 291 (e.g., a pneumatic actuator) is de-energized. When the actuator is exposed to atmospheric pressure, it no longer applies force to tubing pressurization block 248 (e.g., races or raceways), causing one or more compression springs 294 to move tubing pressurization block 248 to a desired safe position (e.g., the NC position), as shown in FIG. 2Q1. With a normally closed pump in the NC position, draw pump 208 acts like a closed valve and does not allow any blood flow through donor supply tubing 104, cassette inlet tubing 108A, or inlet tubing 108B.

[0104] 2R1 and 2R2, a pump such as return pump 212 is shown in a normally open (NO) configuration, as opposed to draw pump 208, which is in a normally closed (NC) configuration. As shown in FIGS. 2R1 and 2R2, return pump 212 has one or more springs, such as compression springs 294′, on the other side of a diaphragm, here diaphragm member 291′. In FIG. 2R1, diaphragm member 291′ is disposed within a cavity 293′ defined within tube pressurizing block 248′. Spring system 290′ is also shown in cross section along with base member 210A′ and tube pressurizing block 248′. Tube pressurizing block 248′ may include an upper lip portion 262′ adjacent to a surface of raceway 246′, the upper lip portion 262′ configured to hold a received tube facing downward against the surface of raceway 246′. The internal components of the spring system 290' include a diaphragm member 291' and a pneumatic coupling 292A'. Also included are one or more compression springs 294' and a spring support structure 295'. As shown in FIG. 2R2, air and / or gas and / or fluid is introduced at 296A', expanding the diaphragm member 291' and pushing against the inner wall 293A', moving the tube pressurizing block 248' toward the rotor subassembly 261 (not shown in FIG. 2R2) to a closed position. Distance "x'" is shown as the distance the tube pressurizing block 248' moves in direction 297' toward the roller. The closed position here is under pneumatic operation relative to a normally open (NO) configuration of the return pump 212. When the air pressure is turned off and / or lost, one or more compression springs 294' return the tube pressurizing block 248' to the open position in the normally open configuration, allowing the saline or plasma to freely return to the centrifuge, depending on the pressure differential, if any.

[0105] 2S1 and 2S2 illustrate a return pump 212. In at least one exemplary embodiment, the return pump 212 may be similar to the draw pump 208. For example, FIGS. 2S1 and 2S2 illustrate at least one exemplary embodiment of the return pump 212 having an exemplary door or tube cover or tube guard 240′. The tube guard covers the inlet guide 244′ and the outlet guide 252′, as well as the tube pressurizing block 248′ and the tubing portion (not shown in FIGS. 2S1-2S2, but see outlet tube 112 in FIG. 2A) associated with the rotor subassembly 261′ (below the rotor cover 236′) on the base member 210A′. The door or tube cover or tube guard 240′ is illustrated herein as including, among other things, a latch hook subsystem with a latch bar 241′ shown disposed as part of and / or connected to the tube cover or tube guard 240′. As previously described, latch bar 241′ is pivotable at and / or about axis 243′ relative to tube guard 240′, while tube guard 240′ is pivotable about axis 242′ relative to inlet guide 244′, outlet guide 252′, and rotor subassembly 261′. Rotational connections 237A′ and 237B′ provide this operative relationship. Similar to the structure and function of aspiration pump 208, hooks 245A′ on or connected to latch bar 241′ are initially engaged with mating hooks 245B′ on inlet guide 244′, as shown in FIG. 2G, and are disengaged by a manual or similar external force applied to latch bar 241′, thereby opening tube guard 240′ as shown in FIGS. 2H and 2I. To close tube guard 240′, the reverse motion or action is used.

[0106] As shown in more detail in FIG. 2S2, return pump 212 is shown without rotor cover 236′ and tube guard 240′. Thus, rotor subassembly 261′ with rotating pressure roller 268′ is exposed. For greater clarity, races or raceways 246′, inlet channel 247′, outlet channel 257′, and associated recesses 253A′, 253B′, and 253C′ for retaining tubing within the pump and for sensors are also exposed. Return pump 212 also includes a tube pressurizing block 248′, similar to tube pressurizing block 248 of draw pump 208, which, in this and various embodiments, is movable in both directions of arrow 259′ relative to rotor subassembly 261′. In at least one exemplary embodiment, tube pressurizing block 248′ may not be perfectly perpendicular to the tubing lines, but may be positioned at a slight angle Θ′ to provide improved locational finder for return pump 212. The raceway 246' and the rotating pressure roller 268' can interact with one another to engage and hold the tube segments in operative relationship within the return pump 212 in much the same manner as described above with reference to the draw pump 208.

[0107] The inlet channel 247′, outlet channel 257′, inlet guide 244′, tubing pressurization block 248′, and outlet guide 252′ of the return pump 212 can include one or more sensors. For example, as shown in FIG. 2S2, the inlet guide 244′ and inlet channel 247′ can include a pressure sensor 255A′. The pressure sensor 255A′, also known as a centrifuge pressure sensor (or CPS), engages the tubing in the inlet channel 247′ to measure or determine the pressure of a fluid therein, such as blood. Because this fluid is in pressure communication with the fluid in the centrifuge upstream of it, a relative centrifuge pressure can be determined from the pressure sensor 255A′. Additionally, if the centrifuge pressure determined from the pressure sensor 255A′ differs significantly from the pressure measured by the pressure sensor 255A of the draw pump 208, an alert may be triggered indicating appropriate action is required. FIG. 2S2 also schematically illustrates a door closure sensor 255B′ and a moving block position sensor 255C′. In at least one exemplary embodiment, door closed sensor 255B′ may be similar to door closed sensor 255B of draw pump 208, but here disposed within exit guide 252′, where it is operatively positioned to sense closure of door or tube guard 240′. Door closed sensor 255B′ may be an inductive sensor or other sensor. In at least one exemplary embodiment, moving block position sensor 255C′ may be similar to moving block position sensors 255C and / or 255D of draw pump 208, and may be disposed below tube pressurizing block 248′ to sense closure of tube pressurizing block 248′ relative to rotor subassembly 261′ (to sense the presence of tube pressurizing block 248′) or to sense opening of tube pressurizing block 248′ relative to rotor subassembly 261′ (to sense the absence of tube pressurizing block 248′).In at least one exemplary embodiment, pressure sensor 255A' may be similar to one or both of moving block position sensors 255C and / or 255D of draw pump 208, and in some embodiments may be an optical sensor that is triggered by the movement / positioning of tube pressurization block 248'.

[0108] In at least one exemplary embodiment, return pump 212 can further include an optical sensor 255D' in or adjacent to inlet channel 247'. Optical sensor 255D' may be positioned on or in inlet guide 244' and / or inlet channel 247' to detect fluid, air, cell concentration, color, and / or color changes in the fluid coming from outlet tubing 112. For example, if red blood cells are sensed in outlet tubing 112, upon reaching a saturation state, plasma collection is at least temporarily stopped and the pump(s) is reversed to return the red blood cells to the donor. Optical sensor 255D' is preferably as close to the centrifuge as reasonably possible and may be positioned on the inlet side of return pump 212, as shown in FIG. 2S2.

[0109] AC pump 216, shown in more detail in Figures 2T1, 2T2, and 2T3, has many similarities to retraction pump 208, but also has many differences because it generally pumps only anticoagulant AC and not blood components or blood products. For example, but not limited to, AC pump 216 is configured to move in only one direction, either to deliver AC or not deliver AC to inlet tubing line 104 / 108A (see Figures 1 and 2A). AC pump 216 may also be configured to rotate faster and / or be configured for use with smaller tubing lines, such as smaller inner diameter (ID) tubing.

[0110] Additionally, AC pump 216 may be a manual pump and may not have the pneumatic block control that draw pump 208 and return pump 212 have. Because free flow of AC to donor 102 may not be optimal during power-off or power failure conditions, AC pump 216 may have a passive spring or similar biasing member to force the raceway into a normally closed configuration.

[0111] Despite these differences, AC pump 216 also shares some similarities with both draw pump 208 and / or return pump 212. For example, in FIGS. 2T1, 2T2, and 2T3, AC pump 216 is shown having a door, tube cover, or tube guard 240''. The tube guard covers the inlet guide 244'' and outlet guide 252'' as well as the tube pressurizing block 248'' and the tubing portion (not shown in FIGS. 2T1-2T3, but see anticoagulant tubing 110 in FIG. 2A) associated with rotor subassembly 261'' (below rotor cover 236'') on base member 210A''. Tube guard 240'' is shown herein specifically as having a latch hook subsystem having latch bar 241'' shown disposed as part of and / or connected to tube guard 240''. As previously described, latch bar 241" is pivotable at and / or about axis 243" relative to tube guard 240", while tube guard 240" is pivotable about axis 242" relative to inlet guide 244" and outlet guide 252" and rotor subassembly 261". Rotational connections 237A" and 237B" provide this operative relationship. Similar to the structure and function of suction pump 208 and return pump 212, hook 245A" on or connected to latch bar 241" is initially engaged with mating hook 245B" of a guide, such as outlet guide 252", and is disengaged by manual or similar external force applied to latch bar 241", as shown in FIG. 2G, thereby opening tube guard 240", similar to the operation shown in FIGS. 2H and 2I-1 for suction pump 208. In at least one exemplary embodiment, a reverse movement or action can close the tube guard 240''.

[0112] FIG. 2T2 shows AC pump 216 without rotor cover 236″ and tube guard 240″. Without rotor cover 236″ and tube guard 240″, rotor subassembly 261″ and rotating pressure roller 268″ are shown. Additionally, races or raceways 246″, inlet channels 247″, and outlet channels 257″, and associated recesses 253A″, 253B″, and 253C″ for retaining tubing within the pump and for sensors are shown. Similar to draw pump 208 and return pump 212, AC pump 216 includes a tube pressure block 248″, which, in this and various embodiments, is movable in both directions of arrow 259″ relative to rotor subassembly 261″. In at least one exemplary embodiment, tube pressure block 248″ need not be perpendicular to the tubing lines, but may be positioned at a slight angle Θ″. This helps to retain the tubing for the sensor and / or resist rolling motion and improve resistance to raceway 246" or tube pressurizing block 248" or tubing movement. Raceway 246" and rotating pressurizing roller 268" can interact with each other and / or protruding portions 256A" and / or 256B" to engage and hold tubing portions in operable relationship within AC pump 216.

[0113] In at least one exemplary embodiment, AC pump 216 includes some differences from one or both of draw pump 208 and return pump 212. For example, AC pump 216 may include inlet channel 247", outlet channel 257", inlet guide 244", tube pressurizing block 248", outlet guide 252", and one or more additional structures and / or sensors. In at least one exemplary embodiment, as shown in FIG. 2T2, inlet guide 244" and outlet guide 252" are reversed in orientation. That is, inlet guide 244" is on the opposite side of rotor subassembly 261" and rotating pressurizing roller 268" and tube pressurizing block 248" compared to return pump 212. Similarly, outlet guide 252" is positioned on the opposite side of rotor subassembly 261" and associated components. In at least one exemplary embodiment, the inlet guide 244'' and the outlet guide 252'' may not be inverted and may be positioned in an orientation configured to interact with other associated operating devices of the apheresis system 200, primarily as shown in Figures 1 and 2A.

[0114] Additionally, the AC pump 216 may include a first cam 273A" and a second cam 273B" configured to assist in opening the tube guard 240 of the AC pump 216. As shown in FIG. 2T3, the first cam 273A" and the second cam 273B" are coupled or connected to the tube guard 240". Thus, the first cam 273A" and the second cam 273B" may enable the opening of the tube guard 240" to access the AC pump 216. In at least one exemplary embodiment, the first cam 273A" and the second cam 273B" each include a surface that may couple with or intersect with the raceway 246". The first cam 273A" and the second cam 273B" move with the tube guard 240" to urge the raceway 246" into position. Thus, only when the tube guard 240'' is closed is the raceway 246'' in place and held in place by the spring force and the first cam 273A'' and second cam 273B''.

[0115] In at least one exemplary embodiment, the inlet guide 244" may have a first sensor 255A" and / or a second sensor 255B" relative to the inlet channel 247". The first sensor 255A" may be an air or bubble detector, which may be any optical, ultrasonic, or other type of sensor configured to detect the presence of fluid and / or air in the anticoagulant tubing 110 of the AC pump 216. In at least one exemplary embodiment, if the first sensor 255A" detects air or other undesirable inclusions, an appropriately modified action may be triggered. In at least one exemplary embodiment, if the first sensor 255A" detects air or other undesirable inclusions, the AC pump 216 may be stopped. Also shown in FIG. 2T2 is a schematic representation of a second sensor 255B" that is a door closure sensor located in the inlet channel 247". In at least one exemplary embodiment, first sensor 255A" may be similar to pressure sensors 255A and 255A' of draw pump 208 and return pump 212. In at least one exemplary embodiment, second sensor 255B" may be similar to door closure sensor 255B of draw pump 208, as second sensor 255B" may be operatively disposed within inlet guide 244" to sense closure of door or tube guard 240". In at least one exemplary embodiment, second sensor 255B" may be an inductive sensor or other sensor, as described above. In at least one exemplary embodiment, AC pump 216 may include additional sensors (not shown). However, because tube pressurizing block 248'' is only passively biased by a spring or similar biasing member, additional block sensors similar to moving block position sensors 255C and / or 255D and / or 255C' may not be included in AC pump 216, although they may optionally be included in at least one exemplary embodiment.

[0116] In at least one exemplary embodiment, the tube pressurizing block 248" is passively pressed into a closed position in the normally closed configuration, so that to load the anticoagulant tube 110, the tube pressurizing block 248" is opened by hand or other manual means or external force to pull the tube pressurizing block 248" away from the rotor subassembly 261". Alternatively, a mechanical relationship may be established that allows the tube pressurizing block 248" to be levered backward away from the rotor subassembly 261" by mechanically rotating the tube guard 240" open and upward about the rotary connections 237A" and 237B". This may be one justification for orienting the tube guard 240" in the opposite direction, toward the tube pressurizing block 248", as shown by the arrow in FIG. 2T1, as opposed to away from the tube pressurizing block 248". Then, when the tube guard 240" is opened, it moves the tube pressurizing block 248" away from the rotor subassembly 261" to open the raceway 246" and allow the tube to be loaded. Then, for closure, the force on the tube guard 240" is released and a spring or similar passive biasing member urges the raceway 246" back into an operable normally closed configuration, engaging the tube against the rotor subassembly 261" and rotating pressurizing roller 268".

[0117] 2U, fluid valve control system 228 of apheresis system 200 is shown along with one or more fluid control valves. In at least one exemplary embodiment, one or more fluid control valves can be used to control the routing or flow direction of fluids delivered through the tubing of apheresis system 200. In at least one exemplary embodiment, apheresis system 200 includes fluid valve control system 228 positioned adjacent saline bag 118 and / or plasma collection bottle 122.

[0118] As shown in FIG. 2U , outlet tubing 112 passes through return pump 212 and is interconnected with saline-plasma tubing y-connector 280. Saline-plasma tubing y-connector 280 connects outlet tubing 112 to saline tubing 116 and plasma tubing 120. Fluid valve control system 228 may include an air detection sensor 284 disposed at a first end of saline-plasma valve housing 276 and surrounding a portion of outlet tubing 112. Air detection sensor 284 may be any optical, ultrasonic, or other type of sensor capable of detecting the presence of fluid or air in outlet tubing 112 and providing a signal to a controller of apheresis system 200. An example of a type of air detection sensor that can be used as air detection sensor 284 is a SONOCHECK ABD05 manufactured by SONOTEC US Inc., or other similar sensors.

[0119] Saline-plasma valve housing 276 includes a plurality of receiving features (e.g., grooves, channels, receptacles, etc.) that receive outlet tubing 112, saline tubing 116, a portion of plasma tubing 120, and / or saline-plasma tubing y-connector 280. Upon detecting air in outlet tubing 112, fluid valve control system 228 selectively activates one or more of the fluid control valves, such as plasma flow control valve 286, saline flow control valve 288. In at least one exemplary embodiment, detection of air via air detection sensor 284 signals and / or triggers an operational step in a control method as described herein.

[0120] The plasma flow control valve 286 and / or the saline flow control valve 288 may be solenoid valves, linear actuators, pinch valves, clamp valves, tubing valves, and / or other actuatable valves configured to selectively alter (e.g., occlude) a fluid passageway associated with a particular portion of the outlet tubing 112, the saline tubing 116, or the plasma tubing 120. As shown in FIG. 2U, the plasma flow control valve 286 may be configured to pinch a portion of the plasma tubing 120 that is at least partially contained within a receiving functional portion of the saline-plasma valve housing 276. The saline flow control valve 288 may be configured to pinch a portion of the saline tubing 116 that is at least partially contained within a receiving functional portion of the saline-plasma valve housing 276. In either case, the plasma flow control valve 286 and the saline flow control valve 288 include extendable fingers that are actuatable to move from a retracted or partially retracted position to an extended or partially extended position to pinch the tubing portion contained within the saline-plasma valve housing 276. It should be understood that while the plasma flow control valve 286 and the saline flow control valve 288 may completely pinch the tubing (e.g., completely restrict fluid flow through the tubing), the plasma flow control valve 286 and the saline flow control valve 288 may also be partially actuated to a position that partially restricts fluid flow in a portion of the tubing.

[0121] Also described herein is a method 300 for fluid control in a pump. While method 300 is described with respect to draw pump 208, it should be understood that method 300 may be performed with return pump 212 and / or AC pump 216. Method 300 begins at step 302, where tubing is inserted into a pump, such as draw pump 208. As described above, the pump may include an inlet guide, such as inlet guide 244, and an outlet guide, such as outlet guide 252. In at least one exemplary embodiment, the tubing is inserted into draw pump 208 through inlet guide 244, rests between raceway 246 and rotor subassembly 261, and exits through outlet guide 252. Tube pressurization block 248 is in a first position when the tubing is inserted into draw pump 208.

[0122] Once the tubing is inserted into the pump, method 300 proceeds to step 304, where the pump is closed. In some embodiments, closing the draw pump 208 can move the tube pressurization block 248 from a first position to a second position. When the tube pressurization block 248 is closed, the tubing is fully occluded between at least one of the rollers of the rotor subassembly 261 and the raceway 246 of the tube pressurization block 248.

[0123] Once the pump is closed, method 300 proceeds to step 306 where the pump is activated or operated. When the pump is activated, rotor subassembly 261 begins to rotate such that at least one roller of rotor subassembly 261 occludes the tube and moves fluid within the tube in a direction corresponding to the rotation of the roller and rotor subassembly 261.

[0124] In at least one exemplary embodiment, the pump may further include a tube guard 240 configured to engage the inlet guide and the outlet guide. For example, the tubing disposed between the tube guard 240 and the inlet guide 244 and the tubing disposed between the tube guard 240 and the outlet guide 252 may be clamped in a diamond shape. The tubing is capable of fluid flow but is fixed in place between the inlet guide 244 and the tube guard 240, and between the outlet guide 252 and the tube guard 240.

[0125] In at least one exemplary embodiment, the tubing may be configured to expand or stretch when the pump is actuated. Inlet guide 244 and outlet guide 252 may include at least one notch, such as notch 244A, configured to accommodate the expanded tubing so that the tubing remains in place within the pump during operation of apheresis system 200.

[0126] Also described herein is a method 400 of fluid control through an apheresis system, such as apheresis system 200. Method 400 begins at step 402, where a first pump is activated to draw whole blood from a donor. In at least one exemplary embodiment, the first pump may be draw pump 208. Method 400 then proceeds to step 404, where whole blood from the donor is received via inlet tubing 108B. Inlet tubing 108B is fluidly connected to apheresis system 200. Method 400 then proceeds to step 406, where the whole blood is moved through the first pump of apheresis system 200. In at least one exemplary embodiment, the whole blood is moved through draw pump 208 to a centrifuge of apheresis system 200. As described above, in at least one exemplary embodiment, whole blood is moved through draw pump 208 via rotor subassembly 261. For example, rotor subassembly 261 begins to rotate such that at least one roller of rotor subassembly 261 occludes a tube, moving fluid within the tube in a direction corresponding to the rotation of the roller and rotor subassembly 261.

[0127] In at least one exemplary embodiment, method 400 proceeds to step 408, where the first pump is stopped. After the first pump is stopped, method 400 proceeds to step 410, where a second pump is activated to move at least one component of the whole blood into a collection component of apheresis system 200. In at least one exemplary embodiment, the second pump may be return pump 212. To activate the second pump, the second pump is moved from a normally open, open state to a closed state. As the second pump transitions from an open state to a closed state, the first pump transitions from a normally closed, closed state to an open state. Thus, when apheresis system 200 is operating, only one of the first pump or the second pump is closed at a time. This allows the first pump and the second pump to operate as valves for apheresis system 200.

[0128] In at least one exemplary embodiment, an apheresis system as described in method 400 may further include a third pump. In at least one exemplary embodiment, the third pump may be AC ​​pump 216 and is in a normally closed state while apheresis system 200 is operating.

[0129] Exemplary systems and methods of this disclosure have been described with respect to apheresis methods and systems. However, to avoid unnecessarily obscuring the present disclosure, the foregoing description omits certain known structures and devices. This omission should not be construed as limiting the scope of the disclosure as set forth in the claims. Specific details are set forth to provide an understanding of the present disclosure. However, it should be understood that the present disclosure may be practiced in a variety of ways other than the specific details set forth herein.

[0130] Furthermore, while the aspects, embodiments, and / or configurations illustrated herein show various components of a system being distributed, certain components of the system may be located remotely, in a remote portion of a distributed network, such as a LAN and / or the Internet, or within a dedicated system. Accordingly, it should be understood that system components may be combined into one or more devices, or that system components may be located at particular nodes of a distributed network, such as an analog and / or digital telecommunications network, a packet-switched network, or a circuit-switched network. From the foregoing discussion, it is also understood that, for computational efficiency, system components may be located anywhere within a distributed network of components without affecting system operation. For example, various components may be located in switches such as PBXs and media servers, gateways, one or more communications devices, one or more user premises, or some combination thereof. Similarly, one or more functional portions of the system may be disposed between a remote communications device and an associated computer device.

[0131] It should further be understood that the various links connecting the elements may be wired or wireless links, or any combination thereof, or any other known or later developed elements capable of providing and / or communicating data to and from the connected elements. These wired or wireless links may also be secure links and may be capable of communicating encrypted information. Transmission media used as links may be any suitable carrier for electrical signals, including, for example, coaxial cable, copper wire, and optical fiber, or may take the form of acoustic or light waves, such as those generated during radio wave and infrared data communications.

[0132] Also, while the flowcharts have been discussed and illustrated with respect to a particular sequence of events, it should be understood that modifications, additions, and omissions can be made to this sequence without substantially affecting the operation of the disclosed embodiments, configurations, and aspects.

[0133] Many variations and modifications of the present disclosure may be employed: some features of the present disclosure may be provided without other features.

[0134] In still other embodiments, the systems and methods of this disclosure may be implemented in connection with special purpose computers, programmed microprocessors or microcontrollers and peripheral integrated circuit elements, ASICs or other integrated circuits, digital signal processors, logic circuits such as hard-wired electronics or discrete component circuits, programmable logic devices or gate arrays, e.g., PLDs, PLAs, FPGAs, PALs, special purpose computers, any equivalent means, etc. In general, any device or means capable of implementing the methodologies described herein may be used to implement various aspects of this disclosure. Exemplary hardware that may be used for the disclosed embodiments, configurations, and aspects includes computers, mobile devices, phones (e.g., cellular, Internet-enabled, digital, analog, hybrid, etc.), and other hardware known in the art. Some of these devices include processors (e.g., single or multiple microprocessors), memory, non-volatile storage, input devices, and output devices. Furthermore, other software implementations, including, but not limited to, distributed processing or component / object distributed processing, parallel processing, or virtual machine processing, may also be constructed to perform the methods described herein.

[0135] In yet other embodiments, the disclosed methods may be readily implemented in connection with software using object or object-oriented software development environments that provide portable source code that can be used on a variety of computer or workstation platforms. Alternatively, the disclosed systems may be implemented partially or fully in hardware using standard logic circuits or VLSI designs. Whether software or hardware is used to implement a system according to this disclosure depends on the speed and / or efficiency requirements of the system, the particular functionality, and the particular software or hardware system or microprocessor or microcomputer system being utilized.

[0136] In yet other embodiments, the disclosed methods may be implemented in part in software that may be stored on a storage medium and executed by a programmed general-purpose computer, special-purpose computer, microprocessor, etc. in cooperation with a controller and memory. In these cases, the disclosed systems and methods may be implemented as programs embedded in a personal computer, such as applets, JAVA or CGI scripts, as resources residing on a server or computer workstation, as dedicated measurement systems, routines embedded in system components, etc. The systems may also be implemented by physically incorporating the systems and / or methods into software and / or hardware systems.

[0137] Although this disclosure describes components and functions implemented in aspects, embodiments, and / or configurations related to particular standards and protocols, the aspects, embodiments, and / or configurations are not limited to such standards and protocols. Other similar standards and protocols not mentioned herein exist and are considered to be included in this disclosure. Furthermore, the standards and protocols mentioned herein, as well as other similar standards and protocols not mentioned herein, are periodically superseded by faster or more efficient equivalents having substantially the same functionality. Such replacement standards and protocols having the same functionality are considered to be equivalents included in this disclosure.

[0138] The present disclosure in its various aspects, embodiments, and / or configurations includes components, methods, processes, systems, and / or apparatus substantially as illustrated and described herein, including various aspects, embodiments, configuration embodiments, subcombinations, and / or subsets thereof. Those skilled in the art will understand how to make and use the disclosed aspects, embodiments, and / or configurations after understanding the present disclosure. The present disclosure in its various aspects, embodiments, and / or configurations includes providing devices and processes in the absence of items not illustrated and / or described herein or in its various aspects, embodiments, and / or configurations, including the absence of items that may be used in the previous devices or processes, e.g., to improve performance, ease, and / or reduce implementation costs.

[0139] The foregoing description has been provided for purposes of illustration and description. It is not intended to limit the disclosure to the form or forms disclosed herein. For example, in the foregoing Detailed Description, various features of the disclosure are grouped together in one or more aspects, embodiments, and / or configurations for the purpose of streamlining the disclosure. Features of the aspects, embodiments, and / or configurations of the disclosure may be combined in alternative aspects, embodiments, and / or configurations other than those described above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and / or configuration. Accordingly, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the present disclosure.

[0140] Furthermore, while the specification has included a description of one or more aspects, embodiments, and / or configurations, and certain variations and modifications, other variations, combinations, and modifications may be within the scope of the present disclosure, e.g., within the skill and knowledge of one of ordinary skill in the art, after understanding the present disclosure, including alternative and / or equivalent structures, functions, ranges, or steps in place of those set forth in the claims, whether or not such alternative and / or equivalent structures, functions, ranges, or steps are disclosed herein, and to the extent permitted, entitlement to include other aspects, embodiments, and / or configurations without publicly seeking to use any patentable subject matter.

Claims

1. 1. A pump for a fluid, the pump comprising: a rotor subassembly having at least one roller; a tube pressurizing block having a raceway and at least one protrusion, the tube pressurizing block being movable between a first position and a second position; an inlet guide having an inlet channel and disposed adjacent a first side of the tube pressurizing block; an outlet guide having an outlet channel and disposed proximate a second side of the tube pressurizing block, the second side of the tube pressurizing block being opposite the first side of the tube pressurizing block such that a substantially linear path is formed between the inlet guide and the outlet guide; a tube guard configured to engage the inlet guide and the outlet guide when the tube guard is in a closed position and to expose at least a portion of the rotor subassembly, the tube pressurizing block, the inlet guide, and the outlet guide when the tube guard is in an open position; Equipped with Pump for fluids.

2. 2. The pump of claim 1, wherein the raceway is curved and configured to contact an arc of the rotor subassembly when the tube pressurizing block is in the first position. pump.

3. 2. The pump of claim 1, wherein the pump is configured to engage a portion of a tube disposed through the inlet guide, the raceway, and the outlet guide. pump.

4. 4. The pump of claim 3, wherein the portion of the tube is configured to be occluded when the tube pressurizing block is in the second position. pump.

5. 5. The pump of claim 4, wherein the at least one roller is configured to engage the portion of the tube to occlude the tube when the tube compression block is in the second position. pump.

6. 4. The pump of claim 3, wherein the tube guard comprises at least one downwardly sloping portion configured to guide the tube into the pump and at least one channel protrusion configured to engage at least one of the inlet channel or the outlet channel when the tube guard is in the closed position. pump.

7. 7. The pump of claim 6, wherein the at least one channel protrusion is configured to engage and partially occlude a portion of the tube between the tube guard and at least one of the inlet guide or the outlet guide when the tube guard is in the closed position. pump.

8. 7. The pump of claim 6, wherein the at least one channel protrusion comprises a first channel protrusion configured to engage the inlet channel when the tube guard is in the closed position, and a second channel protrusion configured to engage the outlet channel when the tube guard is in the closed position. pump.

9. 4. The pump of claim 3, wherein the portion of the tube is configured to expand when the pump is in operation, and the raceway includes at least one sidewall feature configured to collect the expanded portion of the portion of the tube. pump.

10. 10. The pump of claim 1, further comprising at least one sensor disposed proximate to at least one of the inlet guide, the outlet guide, or the tube pressurization block. pump.

11. 11. The pump of claim 10, wherein the at least one sensor is at least one of a pressure sensor, a line sensor, a cover position sensor, a moveable block position sensor, an inductive sensor, an optical sensor, a light sensor, an ultrasonic sensor, or an air or fluid sensor. pump.

12. 10. The pump of claim 1, wherein the tube pressurization block further comprises a cavity containing at least one biasing member configured to maintain the tube pressurization block in at least one of the first position or the second position. pump.

13. 13. The pump of claim 12, wherein the at least one biasing member is at least one spring. pump.

14. 13. The pump of claim 12, wherein the tube pressurization block further comprises at least one driven motion member disposed within the cavity, the at least one driven motion member configured to overcome a force of the at least one biasing member. pump.

15. 15. The pump of claim 14, wherein the at least one driven motion member is a pneumatic diaphragm configured to expand to move the tube pressurization block away from the first position or the second position. pump.

16. 16. The pump of claim 15, wherein the pump is a normally closed pump, the first position is a closed position and the second position is an open position, the at least one biasing member is configured to maintain the tube pressurizing block in the first position, and the at least one driven operating member is configured to overcome a force of the at least one biasing member to move the tube pressurizing block to the second position. pump.

17. 16. The pump of claim 15, wherein the pump is a normally open pump, the first position is a closed position and the second position is an open position, the at least one biasing member is configured to maintain the tube pressurizing block in the second position, and the at least one driven operating member is configured to overcome a force of the at least one biasing member to move the tube pressurizing block to the first position. pump.

18. 13. The pump of claim 12, wherein the pump is an anticoagulant pump and the first position is a closed position. pump.

19. 19. The pump of claim 18, wherein the tube pressurizing block is configured to move from the first position to the second position when an external force is applied to the tube pressurizing block. pump.

20. 10. The pump of claim 1, further comprising a fluid ingress prevention feature configured to collect fluid and prevent fluid from contacting at least one internal pump component. pump.

21. 1. A method for fluid control in a pump, the method comprising: inserting the tube through the inlet guide and the outlet guide into the pump in an open state with the tube pressurizing block in a first position; closing the pump by moving the tube pressurizing block to a second position to completely occlude the tube between at least one roller of a rotor subassembly and a raceway of the tube pressurizing block; operating the pump to rotate the at least one roller and move fluid within the tube in a direction corresponding to the rotation of the roller; having method.

22. 22. The method of claim 21, wherein the pump comprises a tube guard configured to engage the inlet guide and the outlet guide. method.

23. 23. The method of claim 22, wherein when the pump is in a closed state, the tube is disposed between the tube guard and the inlet guide and between the tube guard and the outlet guide. method.

24. 24. The method of claim 23, wherein the tube is clamped in a diamond shape when the tube is disposed between the tube guard and the inlet guide and between the tube guard and the outlet guide. method.

25. 22. The method of claim 21, wherein the tube is configured to expand when the pump is operating, and the inlet guide and the outlet guide have at least one notch configured to accommodate the expanded tube when the pump is operating. method.

26. 1. A method of fluid control through an apheresis system, the method comprising: activating a first pump to draw whole blood from the donor; receiving the whole blood from the donor within the apheresis system via an inlet tube fluidly connected to the apheresis system; moving the whole blood through the first pump of the apheresis system; stopping the first pump; activating a second pump to move at least one component of the whole blood to a collection component of the apheresis system; having the step of operating the second pump includes transitioning the second pump from an open state to a closed state; When the second pump is actuated, the first pump transitions from a closed state to an open state. method.

27. 27. The method of claim 26, wherein the apheresis system further comprises a third pump configured to be in a closed state while the apheresis system is in operation. method.

Images