Fluid control and bypass function 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 the benefit of U.S. Provisional Patent Application No. 63 / 317,489, filed Mar. 7, 2022, and U.S. Provisional Patent Application No. 63 / 318,735, filed Mar. 10, 2022, and claims the priority of U.S. Patent Application No. 18 / 116,527, filed Mar. 2, 2023. The entire disclosure of the above applications is incorporated herein by reference.

[0002] The present disclosure generally relates to fluid control and bypass functional parts, and particularly to fluid control and bypass functional parts in an apheresis system.

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

Background Art

[0004] There are two generally known methods for blood donation / collection. The first method is whole - blood donation from a donor, followed by a centrifugation process to separate blood components from the whole blood based on the density of the blood components. The desired components can be manually, semi - automatically, or automatically transferred to a collection container while the whole blood is under the influence of the forces generated by a centrifuge, or, in some cases, afterwards. The other method is apheresis collection, which requires special equipment.

Summary of the Invention

Problems to be Solved by the Invention

[0005] In the apheresis method, whole blood is extracted from the donor while the donor is connected to a dedicated device. The whole blood is centrifuged to collect only the desired blood components (e.g., plasma), and all other unwanted 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 disadvantages, such as being time-consuming and uncomfortable. In many cases, the donor must remain connected to the device for an hour for blood component donation. Therefore, making the donation procedure more efficient is currently desired in settings where apheresis collection is performed.

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

[0007] The embodiments may provide methods and apparatus for positioning a portion of a disposable item (e.g., a loop) within a medical device. The 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 already mentioned and other needs are addressed by various aspects, embodiments, and / or configurations. While this disclosure provides for exemplary embodiments, it should be understood that individual aspects of this disclosure can be described separately in the claims.

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

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

[0011] In at least one exemplary embodiment, the pump may be configured to engage with a portion of the tube. The portion of the tube may be arranged via the inlet guide, the raceway, and the outlet guide. In at least one exemplary embodiment, the portion of the tube may be configured to partially close when the tube pressure block is in the second position. In at least one exemplary embodiment, the at least one projection and the at least one roller may be configured to engage with the portion of the tube and partially close the tube when the tube pressure block is in the second position. In at least one exemplary embodiment, the tube guard may include at least one channel projection 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 projection may be configured to engage with the portion of the tube and partially close the portion of the tube when the tube guard is in the closed position. In at least one exemplary embodiment, the at least one channel projection may comprise a first channel projection configured to engage with the inlet channel and a second channel projection configured to engage with the outlet channel. In at least one exemplary embodiment, the portion of the tube may be configured to extend when the pump is in operation. The raceway may comprise at least one sidewall functional portion configured to collect the extended portion of the portion of the tube.

[0012] In at least one exemplary embodiment, the pump may further include at least one sensor positioned in proximity to at least one of the inlet guide, the outlet guide, or the tube pressurizing 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 induction 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 pressure block may further comprise a cavity containing at least one biasing member configured to maintain the tube pressure block in at least one of the first or second positions. 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 pressure block may further comprise at least one driven actuating member disposed within the cavity. The at least one driven actuating member may be configured to overcome the force of the at least one biasing member. In at least one exemplary embodiment, the at least one driven actuating member may be a pneumatic diaphragm. The pneumatic diaphragm may be configured to inflate to move the tube pressure block away from the first position to the second position. In at least one exemplary embodiment, the pump is a normally closed pump, the first position is a closed position, the second position is an open position, the at least one biasing member is configured to maintain the tube pressure block in the first position, and the at least one driven member may be configured to overcome the force of the at least one biasing member to move the tube pressure block to the second position. In at least one exemplary embodiment, the pump is a normally open pump, the first position is a closed position, the second position is an open position, the at least one biasing member is configured to maintain the tube pressure block in the second position, and the at least one driven member may be configured to overcome the force of the at least one biasing member to move the tube pressure 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 component configured to collect fluid and prevent the fluid from coming into contact with at least one internal pump component.

[0015] This specification also describes a method for fluid control in a pump. The method comprises the step of inserting a tube into the pump via an inlet guide and an outlet guide. The pump may be open when the tube is inserted with the tube pressure block in a first position. The method further comprises the step of closing the pump by moving the tube pressure block to a second position. The tube may be completely blocked between at least one roller of a rotor subassembly and the raceway of the tube pressure block when the tube pressure block is in the second position. The method further comprises the step of operating the pump by rotating the at least one roller so as to move the 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 with the inlet guide and the outlet guide. In at least one exemplary embodiment, when the pump is closed, the tube may be positioned between the tube guard and the inlet guide and between the tube guard and the outlet guide. In at least one exemplary embodiment, when the tube is positioned between the tube guard and the inlet guide and between the tube guard and the outlet guide, the tube may be clamped in a diamond shape.

[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] This specification also describes a method for fluid control via an apheresis system. This method includes the steps of: activating a first pump to draw whole blood from a donor; receiving whole blood from the donor in 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, the step of activating the second pump includes transitioning the second pump from an open state to a closed state. In at least one exemplary embodiment, when the second pump is activated, the first pump transitions from a closed state to an open state.

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

[0020] Embodiments include a method for collecting blood components by apheresis, the method comprising: 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 has been detected, pushing the separated first blood component back into the centrifuge while the centrifuge continues to rotate, moving at least red blood cells from the centrifuge and returning them to the donor.

[0021] In some embodiments of the above method, 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 method, 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 method, 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 method, the centrifuge rotates at a first speed when separating the first blood component from the whole blood. In some embodiments of the above method, 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 method, the centrifuge rotates at a second speed when drawing whole blood from the donor into the centrifuge. In some embodiments of the above method, the second speed is slower than the first speed. In some embodiments of the above method, a 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 insertion channel formed in the filler.

[0022] The embodiment includes an apheresis system, the apheresis system includes a needle inserted into a donor's blood vessel to draw whole blood from the donor; a first tube having a lumen and being fluidly associated with the needle and moving the whole blood through the lumen; a draw-in pump engaged with the first tube and drawing the whole blood from the donor to a centrifuge; a centrifuge that rotates to apply centrifugal force to the whole blood and separates the whole blood into at least a first blood component and red blood cells; a blood component collection bladder inserted into the centrifuge and being 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. The system includes a second tube connected to the second tube for moving a first blood component from a blood component collection bladder, a collection bottle fluidly associated with the second tube for extracting the first blood component from the apheresis system, a sensor positioned in close proximity to the second tube for detecting that the second blood component has been extracted from whole blood, and a return pump engaged with the second tube for returning the separated first blood component through the second tube to the blood component collection bladder and moving at least red blood cells from the blood component collection bladder back to the donor while the centrifuge continues to rotate after the second blood component has been detected by the sensor.

[0023] In some embodiments of the above 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 above apheresis system further include an anticoagulant pump for drawing an anticoagulant from an anticoagulant bag and mixing the anticoagulant with whole blood in a manifold or junction fluidly associated with the first tube. In some embodiments of the above apheresis system, the centrifuge includes a filler for rotating a blood component collection bladder. In some embodiments of the above apheresis system, the blood component collection bladder is inserted into and held in a collection insertion channel formed in the filler.

[0024] The 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 being fluidly associated with the needle and moving whole blood through the lumen, the first tube through which a draw-in pump engaged with the first tube draws whole blood from the donor; a blood component collection bladder inserted into a centrifuge and being fluidly associated with the first tube and separating a first blood component from the whole blood; and a blood component collection bladder fluidly associated with the blood component collection bladder and The system comprises a second tube for moving a first blood component from a bladder, and a collection bottle fluidly associated with the second tube and for extracting the first blood component from the apheresis system, wherein a sensor is positioned physically close to the second tube to detect that the second blood component has been extracted from whole blood, and after the second blood component has been detected by the sensor, a return pump engaged with the second tube returns the separated first blood component through the second tube to the blood component collection bladder while the centrifuge continues to rotate, and moves at least red blood cells from the blood component collection bladder back to the donor.

[0025] In some embodiments of the blood component collection set described above, the first blood component is plasma, and the second blood component is platelets. In some embodiments of the blood component collection set described above, 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, moving at least red blood cells from the blood component collection bladder back to the donor. In some embodiments of the blood component collection set described above, the blood component collection bladder is inserted into and held in a filler that rotates the blood component collection bladder in a centrifuge. In some embodiments of the blood component collection set described above, the blood component collection bladder is inserted into a collection insertion channel formed in the filler and held therein.

[0026] In some embodiments of the above method, when drawing fluid from the donor in the next draw, a portion of the fluid previously sent to the donor through the DC lumen is retained in the drip chamber when returning red blood cells to the donor and when the whole blood passes through the fluid flow bypass path again.

[0027] Embodiments include a pump for one or more fluids, which are biological fluids, medical fluids, or intravenous fluids, the pump comprising a base member, a rotor subassembly having at least one roller and connected to and supported by the base member, having a partial arc that is operably engaged by being positioned to operably engage with a portion of a tube, and a movable pressurizing block having a race surface and at least one projection, the at least one projection engaging with a portion of a tube adjacent to the rotor and partially deforming but not completely closing, the movable pressurizing block is configured to move to engage or disengage the at least one projection and the race surface, and to position the at least one projection and the race surface in a operable position relative to the rotor subassembly and at least one roller in the partial arc of the rotor subassembly. The rotor comprises: an inlet guide member and an outlet guide member, the inlet guide member having an inlet channel and the outlet guide member having an outlet channel, the inlet guide member and the outlet guide member being arranged on both sides of a movable pressure block, the inlet channel and the outlet channel forming a substantially linear shape to receive a substantially linear tube portion; and a movable cover subassembly rotatably connected to the inlet and outlet guide members, the movable cover subassembly being movably positioned to cover the arcs of the race surface and rotor subassembly and the portions of the inlet channel and outlet channel adjacent to the arcs of the race surface and rotor subassembly movably engaged, the movable cover subassembly having at least one channel projection that enters into a portion of either one or the other of the inlet channel and the outlet channel, engages with a tube portion adjacent to the rotor, and partially deforms the tube portion but does not completely close it.

[0028] In some of the above embodiments, the raceway is curved to conform to the arc shape of the rotor subassembly. In some of the above embodiments, the inlet channel, outlet channel, raceway, and rotor define a substantially linear tube loading arrangement, except for the curved portion of the raceway and the arc of the rotor subassembly that operably engage with the rotor subassembly. In some of the above embodiments, at least one projection of the movable pressurizing block provides a meandering fluid path within the tube portion that engages it. In some of the above embodiments, at least one projection of the movable cover member provides a meandering fluid path within the tube portion that engages it. In some of the above embodiments, at least one projection of the movable pressurizing block includes first and second projections, the first projection defined adjacent to the inlet channel of the inlet guide member, and the second projection defined adjacent to the outlet channel of the outlet guide member, and both the first and second projections provide first and second meandering fluid paths within the tube portions that engage them. In some of the embodiments described above, at least one projection of the movable cover member includes first and second projections, the first projection defined to be operably inserted into an inlet channel of an inlet guide member, and the second projection defined to be operably inserted into an outlet channel of an outlet guide member, and both the first and second projections provide first and second meandering fluid paths within the tubular portion with which they engage. In some of the embodiments described above, at least one projection of the movable cover member includes at least a third projection, the third projection defined to be operably inserted into one of the inlet channel of an inlet guide member and the outlet channel of an outlet guide member, and the third projection provides a third meandering fluid path within the tubular portion with which it engages. In some of the above embodiments, one of the inlet channel and outlet channel has at least a first recess, the first recess defined to operably receive at least one projection of a movable cover member that can be inserted 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 meandering fluid path within the tubular portion that is thereby engaged.In some of the above aspects, the inlet channel or the outlet channel has at least one or more of the second recess and the third recess, and the second and third recesses are defined to operably receive at least one protrusion of a movable cover member that can be inserted 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 provide a serpentine fluid path within the tube portion engaged thereby. In some of the above aspects, at least one protrusion of at least one of the movable pressure block and the movable cover subassembly minimizes one or both of the longitudinal movement of the tube portion in the inlet channel, the outlet channel, or the raceway, and the lateral movement of the tube portion in the inlet channel, the outlet channel, or the raceway.

[0029] Some of the above aspects include a system further comprising at least one sensor disposed in or adjacent to one of the inlet channel or the outlet channel or the movable pressure block raceway. Some of the above aspects include at least one sensor disposed in or adjacent to one of the inlet channel or the outlet channel. In some of the above aspects, the at least one sensor comprises two or more sensors. In some of the above aspects, 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 aspects, at least one protrusion of at least one of the movable pressure block and the movable cover subassembly minimizes the movement of the tube portion relative to at least one sensor.

[0030] Embodiments include a method for minimizing the movement of a tubular portion in a pump for one or more of biological fluids, medical fluids, or intravenous fluids, the method comprising the steps of engaging a portion of the tubular portion with at least one projection of at least one of a movable pressurizing block and a movable cover subassembly to minimize the movement of the tubular portion in one of an inlet channel, an outlet channel, and a raceway, and reducing the movement relative to one or both of a pump roller and a sensor.

[0031] In some of the above embodiments, engagement is one or more of compressing the tube, partially closing the tube, thereby providing a meandering fluid path within the engaged tube portion. In some of the above embodiments, reduction includes one or more of reducing tube movement longitudinally, reducing tube movement transversely, reducing movement to improve rotor and pump efficiency, and reducing movement to improve sensor operability. In some of the above embodiments, the direction of reduction is one or more of the following: 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; transverse direction is across the length of the tube portion; transverse direction is perpendicular to the length of the tube portion, or at one or the other of an angle perpendicular to the right angle or an acute angle.

[0032] Embodiments include a pump for one or more fluids, which are biological fluids, medical fluids, or intravenous fluids, the pump being either normally open or normally closed, the pump comprising: a base member; a rotor subassembly having at least one roller and connected to and supported by the base member, having a partial arc that is operably engaged by being positioned to operably engage with a portion of a tube; and a movable pressurizing block having a race surface positioned to contact the rotor subassembly and completely close the portion of the tube adjacent to the rotor, the movable pressurizing block engaging and disengaging at least one projection and the race surface In a partial arc of the rotor subassembly, at least one projection and a race surface are movable relative to the rotor subassembly and at least one roller to bring them into or out of a movable position, and the movable pressure block has a cavity inside, within which are at least one biasing member disposed to hold the movable pressure block in one of the normally open open position or the normally closed position, and a driven actuating member movably disposed within the cavity to overcome the holding of the biasing member and move the movable pressure block away from the biased normally open open position or normally closed position.

[0033] In some of the above embodiments, the biasing member is at least one spring that biases toward one of the normally open position or the normally closed position. In some of the above embodiments, the driven member is a pneumatic diaphragm movably disposed within the cavity to expand and move the movable pressurizing block toward a normally open position or a normally closed position which is biased. In some of the above embodiments, the movable block has a front inner wall defined within the cavity and located near the raceway surface, a rear inner wall defined within the cavity and located further from the raceway surface than the front inner wall, and a support wall movably associated with the movable block but not structurally connected to the movable block and not movable relative to the mobility of the movable pressurizing block, wherein the biasing member is disposed to engage with the support wall and one or the other of the front inner wall and the rear inner wall, and the driven member is disposed adjacent to one or the other of the rear inner wall and the front inner wall in a position opposite to the biasing member and operates to engage with it. In some of the above embodiments, the movable block has a front inner wall defined within the cavity and located near the raceway surface, a rear inner wall defined within the cavity and located further from the raceway surface than the front inner wall, and a support wall operably associated with the movable block but not structurally connected to the movable block and not movable relative to the mobility of the movable pressurizing block, wherein the biasing member is positioned to engage with the support wall and the front inner wall, and the driven operating member is positioned opposite the biasing member, adjacent to the rear inner wall, and operates to engage with it, and the biasing member assumes a normally closed position. In some of the above embodiments, the driven operating member is operably positioned within the cavity to move the movable pressurizing block away from the normally closed position, which is a biased state.In some of the above embodiments, the movable block has a front inner wall defined within the cavity and located near the raceway surface, a rear inner wall defined within the cavity and located further from the raceway surface than the front inner wall, and a support wall movably associated with the movable block but not structurally connected to the movable block and not movable relative to the mobility of the movable pressurizing block, wherein the biasing member is positioned to engage with the support wall and the rear inner wall, and the driven operating member is positioned opposite the biasing member, adjacent to the front inner wall, and operates to engage with it, and the biasing member assumes a normally open position. In some of the above embodiments, the driven operating member is movably positioned within the cavity to move the movable pressurizing block away from a normally open position which is a biased state. In some of the above embodiments, the driven operating member is movably positioned within the cavity to move the movable pressurizing block away from a normally open position which is a biased state or a normally closed position. In some of the above embodiments, the driven actuating member is a pneumatic diaphragm movably positioned within a cavity to expand and move the movable pressurizing block away from a biased normally open or normally closed position. In some of the above embodiments, the movable pressurizing block further includes at least one projection that engages with a tubular portion adjacent to the rotor and is partially deformed but not completely closed, and the movable pressurizing block is movable in a partial arc of the rotor subassembly, relative to the rotor subassembly and at least one roller, by engaging and disengaging the at least one projection and the race surface.Some of the above embodiments further comprises a movable cover subassembly rotatably connected to inlet and outlet guide members, the movable cover subassembly being operably positioned to cover the portions where the arcs of the race surface and rotor subassembly and portions of the inlet channel and outlet channel adjacent to the arcs of the race surface and rotor subassembly operably engage, wherein the movable cover subassembly has at least one channel projection that enters into a portion of either one or the other of the inlet channel and outlet channel, engages with a tubular portion adjacent to the rotor, and partially deforms the tubular portion but does not completely close it. Some of the above embodiments further comprises 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 positioned on both sides of a movable pressure block, and the inlet channel and outlet channel forming a substantially linear shape to receive a tubular portion substantially linearly.

[0034] Embodiments include a method for positioning a pump in either a normally open or normally closed configuration, the method comprising: providing a movable pressure block for operably engaging a rotor subassembly having a partial arc in either a normally open or normally closed configuration, the movable pressure block having an internal cavity and a race surface positioned to contact the rotor subassembly and completely close a tubular portion adjacent to the rotor, the movable pressure block being able to move to engage and disengage at least one projection and the race surface, thereby enabling the movable pressure block to be operably positioned or disengaged from an operable position relative to the rotor subassembly and at least one roller in the partial arc of the rotor subassembly; biasing the movable pressure block within the cavity to hold it in either a normally open or normally closed position; and driving within the cavity to overcome the holding of a biasing member and move the movable pressure block from the biased normally open or normally closed position.

[0035] The embodiment includes a blood component collection set, the blood component collection set comprising a centrifuge for separating blood components from whole blood, and an inlet tube fluidly connected to a donor and the centrifuge, the centrifuge comprising a pump for one or more fluids selected from biological fluids, medical fluids, or intravenous fluids, the pump comprising a base member, a rotor subassembly having at least one roller and connected to and supported by the base member, having a partial arc that is operably engaged by being positioned to operably engage with a portion of the inlet tube, and a movable pressurizing block having a race surface and at least one projection, the at least one projection engaging with a portion of the inlet tube adjacent to the rotor and partially deforming. The movable pressure block is configured to move to engage and disengage at least one projection and race surface in a partially circular arc of the rotor subassembly, with respect to the rotor subassembly and at least one roller, and to move the at least one projection and race surface into a movable position and to move it out of a movable position; and the movable pressure block is configured to move to engage and disengage at least one projection and race surface in a movable position with respect to the rotor subassembly and at least one roller; and the movable pressure block is configured to move to engage and disengage at least one projection and race surface in a movable position

[0036] The embodiment includes a blood component collection set, the blood component collection set comprising a centrifuge for separating blood components from whole blood, and an inlet tube fluidly connected to a donor and the centrifuge, the centrifuge comprising a pump for one or more fluids, which are biological fluids, medical fluids, or intravenous fluids, the pump being either normally open or normally closed, the pump comprising a base member, a rotor subassembly having at least one roller and being connected to, supported and positioned on the base member, having a partial arc that is operably engaged by being positioned to operably engage with a portion of a tube, and a movable pressurizing block having a race surface positioned to contact the rotor subassembly and completely close the portion of the tube adjacent to the rotor The movable pressure block is movable in a partial arc of the rotor subassembly to the rotor subassembly and at least one roller, by engaging and disengaging at least one projection and a race surface, thereby moving at least one projection and a race surface into an operational position and disengaging from an operational position, the movable pressure block having a cavity inside, the cavity comprising at least one biasing member disposed within the cavity to hold the movable pressure block in one of the normally open open position or the normally closed position, and a driven operating member movably disposed within the cavity to overcome the holding of the biasing member and move the movable pressure block away from the biased normally open open position or normally closed position.

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

[0038] Some of the above embodiments include a method for moving a fluid through an apheresis system, the method comprising: providing a pump for drawing whole blood from a donor; receiving whole blood from the donor in the apheresis system via an inlet tube fluid-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 either or both 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 unit using a return pump, the return pump being normally open and having either or both a movable pressurizing block having at least one protrusion and a movable cover subassembly having at least one cover protrusion.

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

[0040] The embodiment includes an apheresis system, the apheresis system comprising: a needle inserted into a donor's blood vessel to draw whole blood from the donor; a first tube having a lumen and being fluidly associated with the needle and moving the whole blood through the lumen; a draw-in pump engaged with the first tube and drawing the whole blood from the donor to a centrifuge; a centrifuge that rotates to apply centrifugal force to the whole blood and separates the whole blood into at least a first blood component and red blood cells; a blood component collection bladder inserted into the centrifuge and being fluidly associated with the first tube and separating the first blood component from the whole blood; a second tube being fluidly associated with the blood component collection bladder and moving the first blood component from the blood component collection bladder; and a fluidly associated with the second tube and moving the first blood component from the apheresis system. The apheresis system comprises an extraction collection bottle, a sensor positioned in close proximity to a second tube for detecting that a second blood component has been extracted from whole blood, and a return pump engaged with the second tube for returning the separated first blood component through the second tube to a blood component collection bladder, and moving at least red blood cells from the blood component collection bladder back to the donor, after the second blood component has been detected by the sensor and the centrifuge continues to rotate, wherein the extraction 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. The apheresis system in some of the above embodiments further comprises an anticoagulant pump for drawing the anticoagulant from an anticoagulant bag and mixing the anticoagulant with whole blood in a manifold or junction fluidly associated with the first tube.

[0041] The 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 being fluidly associated with the needle and moving whole blood through the lumen, the first tube through which a draw-in pump engaged with the first tube draws whole blood from the donor; a blood component collection bladder inserted into a centrifuge and being fluidly associated with the first tube and separating a first blood component from whole blood; a second tube being fluidly associated with the blood component collection bladder and moving the first blood component from the blood component collection bladder; and a collection bottle being fluidly associated with the second tube and extracting the first blood component from the apheresis system. A sensor is positioned in physical proximity to a second tube to detect that two blood components have been extracted from 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 through the second tube to the blood component collection bladder while the centrifuge continues to rotate, moving at least red blood cells from the blood component collection bladder back to the donor. The draw 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 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 of the above embodiments, the blood component collection set further comprises an anticoagulant pump for drawing an anticoagulant from an anticoagulant bag and mixing the anticoagulant with whole blood at a manifold or junction fluidly associated with the first tube. In some of the above embodiments, the draw-in pump is disengaged when the return pump returns the separated first blood component through the second tube to the blood component collection bladder, thereby moving at least red blood cells from the blood component collection bladder back to the donor.In some of the embodiments described above, the blood component collection set is part of the apheresis system.

[0042] The embodiment includes a pump for a fluid, the pump comprising: a base member; an inlet guide member and an outlet guide member, the inlet guide member having an inlet channel and the outlet guide member having an outlet channel, the inlet guide member and the outlet guide member being positioned on the base member, the inlet channel and the outlet channel forming a substantially linear shape to receive a substantially linear tube portion; and a movable cover subassembly rotatably connected to the inlet and outlet guide members, the movable cover subassembly being operably positioned to cover a portion of the inlet channel and a portion of the outlet channel, the movable cover subassembly having at least one channel projection that enters into a portion of either one or the other of the inlet channel and the outlet channel, engages with a tube portion adjacent to a rotor, and partially deforms the tube portion but does not completely close it.

[0043] In some of the embodiments described above, at least one projection of the movable pressurizing block provides a meandering fluid path within the tubular portion with which it engages.

[0044] In some of the embodiments described above, at least one projection of the movable cover member provides a meandering fluid path within the tubular portion with which it engages.

[0045] In some of the above embodiments, at least one projection of the movable cover member includes at least first and second projections, the first projection being defined to be operably inserted into an inlet channel of an inlet guide member, and the second projection being defined to be operably inserted into an outlet channel of an outlet guide member, and both the first and second projections provide first and second meandering fluid paths within the tube portion that engages them. In some of the above embodiments, the first and second projections have V-shaped surfaces configured to receive the tube portion that engages them. In some of the above embodiments, the V-shaped surfaces have chamfered edges. In some of the above embodiments, one of the inlet channel and outlet channel has at least a first recess defining a valley, and the first recess, the first projection, and the second projection make the interior of the tube portion that engages with the first recess, the first projection, and the second projection rhomboid. In some of the above embodiments, one of the inlet channel and outlet channel has at least a first recess, the first recess being defined to operably receive at least one projection of a movable cover member that can be inserted into one of the inlet channel of an inlet guide member and one of the outlet channel of an outlet guide member, and the first recess provides a meandering fluid path within the tube portion that is thereby engaged. In some of the above embodiments, the inlet channel or 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 projection of a movable cover member that can be inserted into one of the inlet channel of an inlet guide member and one of the outlet channel of an outlet guide member, and the second and third recesses provide a meandering fluid path within the tube portion that is thereby engaged. In some of the above embodiments, at least one projection of at least one of the movable cover subassemblies is configured to minimize at least one of the longitudinal movement of the tube portion in the inlet channel, outlet channel, or raceway, and the lateral movement of the tube portion in the inlet channel, outlet channel, or raceway.

[0046] One or more of the embodiments / models substantially disclosed herein.

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

[0048] One or more means configured to carry out one or more of the embodiments / models substantially disclosed herein.

[0049] This disclosure may offer many advantages depending on the particular aspect, embodiment, and / or configuration. By maintaining the centrifuge rotation speed while transferring and returning unnecessary blood components to the donor, the apheresis procedure time can be reduced by up to 30% in some cases. This increased efficiency enables faster and more comfortable donor donation. Faster donor donation times allow donor donation centers to obtain more donor donations in a typical day, increasing productivity and revenue. Furthermore, faster donor donations make donors more likely to return for further donations. Faster donor donations also allow donor donation centers to attract donors who are currently using other donor donation centers with slower donation rates.

[0050] These and other advantages will become apparent from this disclosure.

[0051] The phrases "at least one," "one or more," and "and / or" are non-restrictive expressions that are both conjunctive and disjunctive in their function. For example, the expressions "at least one of A, B, and C," "at least one of A, B, or 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 “one (a)” or “one (an)” + existence refers to one or more such existences. Accordingly, the terms “one (a)” (or “one (an)”), “one or more (one or more)” and “at least one” may be used interchangeably in this specification. It should also be noted that the terms “comprising,” “including,” and “having” may be used interchangeably.

[0053] As used herein, the term “donor” may mean any person who provides a fluid, such as whole blood, to an apheresis system. The donor may also be a patient who temporarily provides a fluid to the apheresis system, which is processed, treated, manipulated, etc., before being returned to the patient.

[0054] As used herein, the term “automatic” and its variations refer to any process or action that is performed without substantial human input when it is performed. However, even if significant or insignificant human input is used in the execution of a process or action, the process or action may be automatic if such input is accepted before the execution of the process or action. Human input is considered significant if it affects how the process or action is performed. Human input that signifies consent to the execution of a process or action is not considered “significant.”

[0055] As used herein, the term “computer-readable medium” refers to any tangible storage device and / or transmission medium involved in providing instructions to a processor for execution. Such mediums can take many forms, but are not limited to non-volatile media, volatile media, and transmission media. Examples of non-volatile media include NVRAM, magnetic disks, or optical disks. Examples of 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 tapes, or any other magnetic media, magneto-optical media, CD-ROMs, any other optical media, punch cards, paper tapes, any other physical media with hole patterns, RAM, PROMs, and EPROMs, FLASH-EPROMs, solid media such as memory cards, any other memory chips or cartridges, carriers as described below, or any other computer-readable media. Digital files or other embedded information archives or sets of archives attached to email are considered distribution media equivalent to tangible storage media. When a 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 similar. Accordingly, this disclosure is considered to include tangible storage media or distribution media on which a software implementation of the disclosure is stored, as well as equivalents and successor media recognized as prior art.

[0056] As used herein, the term “module” refers to any known or subsequently developed hardware, software, firmware, artificial intelligence, fuzzy logic, or combination of hardware and software capable of performing functions associated with such elements.

[0057] The terms “determine,” “calculate,” and “operate” as used herein, and their variations thereof, are to be used interchangeably and include any type of methodology, process, mathematical operation, or technique.

[0058] The term “means” as used herein should be understood to be given its broadest possible interpretation in accordance with paragraph 6 of 35 U.S.SC Section 112. Accordingly, any claim containing the term “means” shall encompass all structures, materials, or actions and all equivalents thereof described herein. Furthermore, structures, materials, or actions and their equivalents shall include all those described in the summary of the invention, the brief description of the drawings, the detailed description, the abstract, and the claims themselves.

[0059] The above is a simplified overview of the Disclosure to give an understanding of some aspects of the Disclosure. This overview is neither an extensive nor a comprehensive overview of the Disclosure and its various aspects, embodiments, and / or configurations. It does not attempt to identify important or significant elements of the Disclosure, nor to delineate the scope of the Disclosure, but rather to provide a simplified form of selected concepts of the Disclosure as an introduction to the more detailed description provided below. To make it understandable, other aspects, embodiments, and / or configurations of the Disclosure may be conceivable that utilize one or more of the features described above or described below, either individually or in combination. [Brief explanation of the drawing]

[0060] [Figure 1] Figure 1 is a perspective view of the operating environment of an apheresis system according to an embodiment of this disclosure. [Figure 2A] Figure 2A is a perspective view of the apheresis system shown in Figure 1. [Figure 2B] Figure 2B is a first detailed perspective view of a pump in an apheresis system according to an embodiment of the present disclosure. [Figure 2C] Figure 2C is a second detailed perspective view of a pump in an apheresis system according to an embodiment of the present disclosure. [Figure 2D] Figure 2D is a perspective view of an embodiment of the present disclosure. [Figure 2E]Figure 2E is a perspective view of an embodiment of the present disclosure. [Figure 2F] Figure 2F is an elevation view of an embodiment of the present disclosure. [Figure 2G] Figure 2G is an elevation view of an embodiment of the present disclosure. [Figure 2H] Figure 2H is an elevation view of an embodiment of the present disclosure. [Figure 2I-1] Figure 2I-1 is an elevation view of an embodiment of the present disclosure. [Figure 2I-2] Figure 2I-2 is a perspective view of an embodiment of the present disclosure. [Figure 2I-3] Figure 2I-3 is a cross-sectional view of an embodiment of the present disclosure. [Figure 2I-4] Figure 2I-4 is a cross-sectional view of an embodiment of the present disclosure. [Figure 2J] Figure 2J is a perspective view of an embodiment of the present disclosure. [Figure 2K1] Figure 2K1 is a plan view of an embodiment of the present disclosure. [Figure 2K2] Figure 2K2 is a plan view of an embodiment of the present disclosure. [Figure 2L1] Figure 2L1 is a plan view of an embodiment of the present disclosure. [Figure 2L2] Figure 2L2 is a plan view of an embodiment of the present disclosure. [Figure 2M1] Figure 2M1 is a perspective view of an embodiment of the present disclosure. [Figure 2M2] Figure 2M2 is a cross-sectional view of an embodiment of the present disclosure. [Figure 2M3] Figure 2M3 is a perspective view of an embodiment of the present disclosure. [Figure 2M4] Figure 2M4 is a cross-sectional view of an embodiment of the present disclosure. [Figure 2N] Figure 2N is a perspective view of an embodiment of the present disclosure. [Figure 2O] Figure 2O is a perspective view of an embodiment of the present disclosure. [Figure 2P1] Figure 2P1 is a cross-sectional view of an embodiment of the present disclosure. [Figure 2P2] Figure 2P2 is an exploded view of an embodiment of the present disclosure. [Figure 2Q1]Figure 2Q1 is a schematic diagram of an embodiment of the present disclosure. [Figure 2Q2] Figure 2Q2 is a schematic diagram of an embodiment of the present disclosure. [Figure 2R1] Figure 2R1 is a schematic diagram of an embodiment of the present disclosure. [Figure 2R2] Figure 2R2 is a schematic diagram of an embodiment of the present disclosure. [Figure 2S1] Figure 2S1 is a perspective view of an embodiment of the present disclosure. [Figure 2S2] Figure 2S2 is a plan view of an embodiment of the present disclosure. [Figure 2T1] Figure 2T1 is a perspective view of an embodiment of the present disclosure. [Figure 2T2] Figure 2T2 is a plan view of an embodiment of the present disclosure. [Figure 2T3] Figure 2T3 is a perspective view of an embodiment of the present disclosure. [Figure 2U] Figure 2U is a detailed perspective view of a fluid valve control system according to an embodiment of the present disclosure. [Figure 3] Figure 3 is a flowchart of the fluid control method in a pump. [Figure 4] Figure 4 is a flowchart of a fluid control method via an apheresis system. [Modes for carrying out the invention]

[0061] In the attached diagram, similar components and / or features may have the same reference label. Furthermore, different components of the same type may be distinguished by a character following the reference label that distinguishes similar components from each other. If only the first reference label is used in the specification, its description can be applied to any one of the similar components having the same first reference label, regardless of the second reference label.

[0062] Embodiments of this disclosure are described in relation to apheresis methods and systems. The following embodiments are described with respect to the separation of blood components from whole blood. However, these are given for illustrative purposes only. The embodiments are not limited to the following description. The embodiments are intended for use in products, processes, apparatus, and systems for pumping fluids. For example, the embodiments disclosed herein may be used to separate any complex liquid. Thus, this disclosure is not limited to the separation of blood components from whole blood.

[0063] Figure 1 shows a perspective view of the operating environment 100 of the apheresis system 200 according to at least one exemplary embodiment of the present disclosure. The operating environment 100 includes the apheresis system 200, a donor 102, and one or more connections (e.g., a donor supply tube 104, a cassette inlet tube 108A, an anticoagulant tube 110, etc.) extending from the donor 102 to the apheresis system 200 and / or vice versa. As shown in Figure 1, the donor supply tube 104 is fluidly connected to at least one blood vessel of the donor 102, e.g., a vein, by venipuncture. For example, a cannula connected to the end of the donor supply tube 104 is inserted through the skin of the donor 102 and inserted 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 original donor 102. In at least one exemplary embodiment, the fluid pathways and connection portions may form an extracorporeal tubular circuit of the apheresis system 200.

[0064] Blood supplied from donor 102 flows along donor supply tube 104 through tube connector 106 and into soft cassette assembly 300 along cassette inlet tube 108A. The 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. The apheresis system 200 may include an anticoagulant supply source contained in anticoagulant (AC) bag 114. The anticoagulant is pumped through at least anticoagulant tube 110 and tube connector 106 to prevent blood clotting in the apheresis system 200.

[0065] The anticoagulant may include, but is not limited to, one or more citrates and / or unfractionated heparin. The AC bag 114 and other bags or bottles described herein may be formed from, but are not limited to, one or more of the following: polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene with vinyl acetate (EVA), rubber, silicone, thermoplastics, thermoplastic elastomers, polymers, copolymers, and / or combinations thereof. The amount of AC in the AC bag 114 may vary based on various factors, including the mass of the donor 102 and the volumetric flow rate of blood from the donor. In one example, the volume in the AC bag 114 is 250-500 mL, but 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 tubes (such as a saline tube 116 or a plasma tube 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 fluid prepared in the saline bag 118 is 500 to 800 mL, but the volume of the saline bag 118 may be larger or smaller than this volume. An example of the amount of blood component (e.g., plasma) collected may be 880 mL. Therefore, 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 substantially at, adjacent to, or physically close to the bottom of the plasma collection bottle 122 (for example, when the plasma collection bottle 122 is placed in the plasma collection cradle 232C, as shown in Figure 2A). The connection point may include one or more connectors configured to interconnect with the plasma tube 120 for receiving and / or transporting plasma. Placing the connection point at the bottom of the plasma collection bottle 122 allows the plasma contained in the plasma collection bottle 122 to flow back from the plasma tube 120 through the line without trapping air bubbles or the like, as described herein. 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 therefore the plasma collection bottle 122 is not limited to a bottle or bottle-like container.

[0067] Figure 2A shows a perspective view of the apheresis system 200 described in Figure 1. The apheresis system 200 enables a continuous whole blood separation process. In at least one exemplary embodiment, whole blood is collected from donor 102 and supplied substantially continuously to the blood component separator of the apheresis system 200. In the blood component separator, 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 donor 102. Blood is collected from donor 102 and guided to the centrifuge of the apheresis system 200 through the opening 220 of the access panel 224 of the apheresis system 200. In at least one exemplary embodiment, the donor supply tube 104, cassette inlet tube 108A, inlet tube 108B, outlet tube 112, saline tube 116, and plasma tube 120 used in an extracorporeal tubing circuit collectively constitute a closed-system sterile disposable system or blood component collection set, as further described below.

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

[0069] The operation of various pumps, valves, and blood component separators or centrifuges may be controlled by one or more processors included in the apheresis system 200, and preferably by multiple embedded computer processors that are part of a computer system. The computer system may include components that allow a user to interface with the computer system, including, for example, memory and storage devices (RAM, ROM (e.g., CD-ROM, DVD), magnetic drives, optical drives, flash memory, etc.), communication / network devices (e.g., wired such as modems / network cards, or wireless such as WiFi), input devices such as keyboards, touchscreens, cameras, and / or microphones, and output devices such as displays and audio systems. In at least one exemplary embodiment, to assist the operator of the apheresis system 200 in various aspects of its operation, the blood component separator or centrifuge may include a graphical user interface with a display including an interactive touchscreen.

[0070] The apheresis system 200 may include a housing 204 and / or a structural frame, a cover 210, access panels 224 located at the front 202 and / or rear 206 of the apheresis system 200, and one or more supports 232A-232C. The supports include hooks, rests, cradles, arms, protrusions, plates, and / or other support functional parts for holding, placing, and / or supporting a container or AC bag 114, saline bag 118, plasma collection bottle 122. In at least one exemplary embodiment, the functional parts of the apheresis system 200 are described in relation to a coordinate system 103 and / or one or more axes thereof. The housing 204 may include an apparatus frame (formed, for example, from welded, bolted, and / or connected structural elements, extruded materials, beams, etc.) to which one or more panels, such as a cover 210, a base member 210A (see, for example, Figures 2D to 2T3), a door, a subassembly, and / or components, may be mounted. In at least one exemplary embodiment, at least one panel of the apheresis system 200 may have a mounting surface for a soft cassette assembly 300, a first normally closed pneumatic pump such as a draw pump 208, a second normally closed pneumatic pump such as a return pump 212, a normally open pump such as an AC pump 216, and / or a fluid valve control system such as a fluid valve control system 228 (e.g., plasma-saline valve control).

[0071] The access panel 224 may include one or more handles, locks, and pivot or hinge shafts 226 (e.g., door hinges, piano hinges, continuous hinges, cleanroom hinges, etc.). In any case, the access panel 224 is selectively opened to allow access to the interior of the apheresis system 200, more specifically, to the blood separation assembly or centrifuge. In at least one exemplary embodiment, the access panel 224 allows access to the interior when attaching and / or removing one or more components of the blood component collection set to the centrifuge.

[0072] The interior of the apheresis system 200 may be divided into at least a centrifugal separation section and a control section. For example, the centrifugal separation section includes a cavity configured to accommodate a centrifugal separator, a rotary 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 (configured to house or include, for example, a motor controller, a CPU or processor, electronic equipment, wiring, etc.) may be provided by a panel separate from the rigidly fastened panel of the housing 204 and / or the access panel 224.

[0073] In at least one exemplary embodiment, the 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 fluid (e.g., blood and / or blood components, anticoagulants, saline solution, etc.) toward, through, or away from the apheresis system 200, as shown in more detail in Figures 2A to 2U. For example, as schematically shown in Figure 2A, the apheresis system 200 includes a draw pump 208 that controls the flow of blood from the donor 102 to the centrifuge of the apheresis system 200 and / or the flow of blood from the centrifuge to the donor 102. The draw pump 208 may engage with the portion of the inlet tube 108B that is located between the soft cassette assembly 300 and the centrifuge of the apheresis system 200. In at least one exemplary embodiment, the apheresis system 200 includes a return pump 212 configured to control the flow of separated blood components (e.g., plasma) from the centrifuge to the plasma collection bottle 122 and / or vice versa, via tubular portions such as the outlet tube 112 and / or the plasma tube 120. In addition to or instead of this, the return pump 212 may control the flow of saline (supplied from the saline bag 118 via tubular portions such as the saline tube 116 and / or the outlet tube 112) throughout the blood component collection set and / or the apheresis system 200. An AC pump 216 may engage with a portion of the anticoagulant tube 110 to selectively control the flow of anticoagulant to the inlet tube 104 / 108A throughout the blood component collection set of the apheresis system 200.As shown in Figure 2A, the intake pump 208, return pump 212, or AC pump 216 may be at least partially positioned on top of the cover 210 of the apheresis system 200, or, in particular, may be connected to the base member 210A, base member 210A', or base member 210A'' in order to be attached in another way to the cover 210 or housing 204 or components and / or components within the apheresis system that are operationally related to the cover 210 or housing 204 or the apheresis system 200, as shown in Figures 2D to 2T3.

[0074] Figures 2B, 2C, 2D, and 2E show various perspective views of the suction pump 208, return pump 212, or AC pump 216 of an apheresis system 200 according to at least one exemplary embodiment of the present disclosure. While the suction pump 208, return pump 212, and AC pump 216 are described herein in relation to an apheresis system, it should be understood that they are not limited to use within an apheresis system. The suction pump 208 is most specifically shown and described with reference to Figures 2B–2M4, among others, but it should be understood that the other pump assemblies of the apheresis system 200, namely the return pump 212 and AC pump 216, differ in some details and may operate differently. However, in many cases, the return pump 212 and / or AC pump 216 may be substantially similar in structure to, or contain similar structural parts to, the suction pump 208 described, even if they are not identical. For explanatory purposes, the suction pump 208 is described first, followed by the differences between the return pump 212 and the AC pump 216 and other details. Exemplary elevation views of the suction 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 are described below, some of which are illustrated in some figures but not in others.

[0075] As shown in some of Figures 2B to 2J, the suction pump 208 may include a pump cover 236 or housing configured to at least partially accommodate the moving elements of the suction pump 208. In at least one exemplary embodiment, the suction pump 208 may include a hinged tube guard door subassembly or tube guard 240 configured to open and close around a tube guard pivot shaft 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 arranged along the tube guard pivot shaft 242, or, as shown in other embodiments such as Figures 2D and 2K1, the guard 240 may be connected to respective guides such as an inlet guide 244 and an outlet guide 252 via rotating connectors 237A, 237B. The door or tube guard 240 also holds the tube in place for sensors to reduce or prevent the movement of the tube. As shown in Figures 2B and 2C, the blood supplied by the donor 102 may be transported to or drawn into the centrifuge by the suction pump 208 in the first draw-in direction, i.e., the centrifuge direction 250A. In addition to or instead of this, blood or other fluid may be transported to or drawn into the donor 102 by the suction pump 208 in the donor direction 250B, opposite to the centrifuge direction 250A.

[0076] In at least one exemplary embodiment, the suction 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 solution, etc.) in at least a portion of the tubing. For example, the suction pump 208, return pump 212, or AC pump 216 may include a motor operably interconnected with the rotating tube contact assembly. During operation, the tubing (e.g., inlet tube 108B, outlet tube 112, anticoagulant tube 110, etc.) may be inserted into the inlet guide 244, tube pressurizing block 248, and outlet guide 252 adjacent to the rotating tube contact head or rotor subassembly 261 (see Figures 2C and 2K1). In at least one exemplary embodiment, the tube pressure block 248 may be moved away from the rotating tube contact head of the draw pump 208, return pump 212, or AC pump 216 to provide a mounting clearance area and / or, as desired, to close or unclose the tube. The reverse may also be done. The rotating tube contact head or rotor subassembly 261 (see in particular Figures 2C and 2K1) comprises a plurality of rotating pressure rollers 268, each roller configured to rotate around its respective pressure roller rotation axis 264 (Figure 2C). Each of the rotating pressure rollers 268 may be positioned between a first rotating plate 272A and a second rotating plate 272B of the rotor subassembly 261, as shown in Figure 2C, in which case the first rotating plate 272A and the second rotating plate 272B may rotate around the pump rotation axis 260 and be configured 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 the first and second ends of the rotor subassembly 261, in which case the first rotating plate 272A and the second rotating plate 272B are the functional parts of the rotor subassembly 261.In at least one exemplary embodiment, the rotating pressure roller 268 may be positioned around or near the first rotating plate 272A and the second rotating plate 272B.

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

[0078] Generally, as shown, for example, in Figures 2C, 2L1, and / or 2L2, when the tube is loaded into the leading portion, i.e., the inlet guide 244, in particular the tube pressure block 248, and / or the rear portion, i.e., the outlet or outlet guide 252, at least some of the rotating pressure rollers 268 of the rotor subassembly 261 engage with, contact, or otherwise press against the tube positioned between the rotor subassembly 261 and the tube pressure block 248. As the rotor subassembly 161, including the first rotating plate 272A and the second rotating plate 272B, rotates around the pump rotation axis 260, the rotating pressure rollers 268 press against the tube portion between the rotor subassembly 261 of the draw pump 208, return pump 212, or AC pump 216 and the tube pressure block 248, and as the rotating pressure rollers 268 move, the fluid inside the tube portion can be reliably moved in a particular direction, such as the centrifuge direction 250A or the donor direction 250B. For example, if the rotor subassembly 261 rotates counterclockwise around the pump rotation axis 260, the rotation of the rotary pressure roller 268 pressing the tube between the rotary pressure roller 268 and the tube pressure block 248 can move or deliver the fluid in the centrifuge direction 250A. As another example, if the rotor subassembly 261 rotates clockwise around the pump rotation axis 260, the rotation of the rotary pressure roller 268 pressing the tube between the rotary pressure roller 268 and the tube pressure block 248 can move or deliver the fluid in the donor direction 250B.

[0079] In at least one exemplary embodiment, when the suction pump 208 is closed and the tube is positioned between the rotor subassembly 261 and the tube pressure block 248, at least one of the rotating pressure rollers 268 engages with the tube to completely occlude it. As the rotor subassembly 261 rotates, the rotating pressure rollers 268 move relative to the tube pressure block 248 as described above. As shown in Figure 2K1, the rotor subassembly 261 may be designed to have seven rotating pressure rollers. This can ensure that when the suction pump 208 is closed, the portion of the tube between the rotor subassembly 261 and the tube pressure block 248 is completely occluded for the entire time the rotor subassembly 261 is rotating. For example, when one of the rotating pressure rollers 268 is disengaged from a portion of the tube near the outlet guide 252, the rotating pressure roller near the inlet guide 244 engages with the tube to keep the other portion of the tube completely occluded. In other embodiments, the rotor subassembly 162 may be designed with more or fewer rotating pressure rollers 268 so that the tubular portion between the rotor subassembly 261 and the tube pressure block 248 is completely closed when the draw-in pump 208 is in the closed position.

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

[0081] The tube guard 240 and pump cover 236 serve to protect the operator (e.g., a phlebotomist, apheresis technician, etc.) and / or donor 102 from accidental contact with one or more moving parts of the draw-in pump 208, return pump 212, and AC pump 216. In at least one exemplary embodiment, the tube guard 240 may be held in a closed position via one or more guard closing functional parts 254 (see Figure 2C) or hooks 245A, hook 245B, hook 245C, or hook 245D (in particular, see Figures 2D-2J, 2S1, and / or 2T1) positioned on or operationally associated with the tube guard 240, inlet guide 244, tube pressurization block 248, and / or outlet guide 252. These guard closing functional parts 254 may be magnets (Figure 2C) or springs housed in the tube guard 240, the leading portion i.e., the inlet guide 244, the tube pressurizing block 248, and / or the rear portion i.e., the outlet guide 252. In at least one exemplary embodiment, the draw-in pump 208, the return pump 212, and the AC pump 216 may be stopped or not moved / operated when the tube guard 240 is open. In this embodiment, the door closing sensor 255B (e.g., Figure 2K2) and / or 255B' (Figure 2S2) may be included in one or more of the guard closing functional parts 254, the inlet guide 244 (Figure 2K2), and the outlet guide 252 (for 255B' in Figure 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 Figures 2D–2J, an exemplary suction pump 208 is shown with an exemplary door or tube guard 240, which covers a portion of the tube (not shown in Figures 2D–2J) with respect to the inlet guide 244 and outlet guide 252, as well as the tube pressurizing block 248 and the rotor subassembly 261 (located beneath the pump cover 236). The door or tube guard 240 is shown herein to include, in particular, a latch hook subsystem. In particular, a latch bar 241 is shown as being provided as part of the tube cover or tube guard 240 and / or connected thereto. In these examples, the latch bar 241 is pivotable on and / or about the axis 243 relative to the tube guard 240.

[0083] Figures 2E, 2F, 2G, 2H, and 2I-1 illustrate the exemplary opening process of the tube guard 240 relative to the inlet guide 244, the outlet guide 252, and the tube pressure block 248. Let's assume we begin from the closed position as shown in Figures 2D and 2F. In this closed position, we can see that the hook 245A on, or connected to, the latch bar 241 is initially engaged with the hook 245B of the inlet guide 244. Similarly, in Figure 2E, the hooks 245C and 245D are shown as relating to the outlet guide 252. In Figure 2G, the latch bar 241 is shown, here counterclockwise, to disengage the hooks 245A and 245B from each other, but is not limited to this. This rotation is about axis 243. Next, the door or tube guard 240 can be rotated counterclockwise, but not limited to, around the tube guard pivot shaft 242, as shown in Figure 2H (see also, for example, Figure 2E), to be brought to a substantially open position, as shown in Figures 2I-1 and 2J. This rotation of the tube guard 240 is performed via rotational connections 237A and 237B to the inlet guide 244 and the outlet guide 252, respectively, as shown in Figure 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 to the tube, tube guide, pressure block, and rotor subassembly. The latch bar 241 may be subjected to force using a spring so as to be biased toward the non-rotating position shown in Figures 2F and 2H, 2I-1, and 2J, after the external force applied, for example, in Figure 2G, has been removed. In at least one exemplary embodiment, the hook 245A may be manually engaged by an operator to disengage the hook 245A from the mating hook 245B. To reengage the hook 245A and the mating hook 245B, the operator pushes down on the tube guard 240. When force is applied to the tube guard 240, the tube guard 240 rotates around the tube guard pivot axis 242, and the hook 245A engages with the mating hook 245B such that the tube guard 240 is in the closed position as shown in Figures 2D and 2F.

[0084] Starting from Figure 2E and progressing through various stages shown in Figures 2F to 2M2, in loading the tubing into the pump, channels such as inlet channel 247 and outlet channel 257, corresponding to inlet guide 244 and outlet guide 252, receive the tubing, and as shown in more detail in Figures 2L1 and 2L2, portions of the tubing, such as inlet tube 108B, are received or positioned in the channels in a substantially linear or in-line configuration. This is sometimes referred to as linear tubing loading. In at least one exemplary embodiment, linear tubing loading allows the use of pump tubing or pump header tubing that is not different from the tubing used throughout the entire tubing set. Furthermore, several other structural and procedural functional parts can make this embodiment suitable for the use of pump tubing or pump header tubing that is not different from the tubing used throughout the entire tubing set. More specifically, in this embodiment, different tubing is not required for the tubing portions that engage within the engagement area between the rotor and the race. Using a common type of tubing can lower manufacturing and parts procurement costs. In previous systems, specially manufactured tubing was preferred or required for use in / with pumps because a certain amount of plasticizer and a strictly controlled tubing thickness were necessary for adequate minimum operability and safety. In at least one exemplary embodiment, the tubing used herein may be manufactured from materials such as silicone or different tubing polymers. Furthermore, the embodiments described herein can increase the lifespan of the tubing. As described herein, in this embodiment, controlled forces are applied to the tubing structurally and procedurally, which vary based on the tubing itself, its relative thickness and the amount of plasticizer.

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

[0086] Referring to Figures 2I-2 to 2I-4, each of the projections 249A, 249B, and 249C of the tube guard 240 includes molded surfaces 251A, 251B, and 251C on their respective projections 249A, 249B, and 249C. The molded surfaces 251A, 251B, and 251C assist in the engagement of the tube 108B. In at least one exemplary embodiment, the molded surfaces 251A, 251B, and 251C may be relatively curved or may be inverted V-shaped surfaces. In at least one exemplary embodiment, at least one of the molded surfaces 251A, 251B, and 251C may include a V-shaped notch 251D. The protrusions 249A, 249B, and 249C, the molded surfaces 251A, 251B, and 251C, and the V-shaped notch 251D (see Figures 2I-1 to 2I-4) are positioned to enter and be set in the respective recesses 253A, 253B, and 253C of the inlet guide 244 and the outlet guide 252 (see, for example, Figures 2K1 and 2K2). 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. In other embodiments, it will be understood that the inlet block-side portion 201A and the outlet block-side portion 201B may include one, two, or more protrusions.

[0087] When the tube guard 240 is closed against the inlet guide 244 and outlet guide 252, the projections 249A, 249B, and 249C, having molded surfaces 251A, 251B, and 251C, enter their respective recesses 253A, 253B, and 253C, engaging and pushing the tube placed therein without completely blocking it. This engagement is partially blocked so that the fluid flow through the inlet tube 108B is slightly affected. This may provide a meandering path but does not completely block the inlet tube 108B. As shown in Figure 2I-3, when the tube guard 240 is closed against the inlet guide 244 and outlet guide 252, the inlet tube 108B may be clamped so that it is operated to have a substantially rhomboid cross-section. The engagement primarily provides a restraining and holding function to reduce or eliminate the movement of the tube within the draw-in pump 208, in particular within the raceway / pump roller engagement area (described further below).

[0088] As shown in Figure 2I-4, the tube guard 240 may form an angle Θ with the inlet guide 244 and the outlet guide 252. The angle Θ associated with the downward-sloping portion 231 helps to guide the inlet tube 108B into a portion of the suction pump 208 so that the inlet tube 108B is directed downward when it enters the suction pump 208 and is positioned to be closed by the rotating pressure roller 268 in the suction pump 208.

[0089] For illustrative purposes, 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 multiple rotating pressure rollers 268 is exposed. Also, for greater clarity, the race or raceway 246, inlet channel 247, and outlet channel 257, as well as the associated recesses 253A, 253B, and 253C are shown exposed, particularly in Figures 2K1 and 2K2. In this embodiment and in other embodiments, the tube pressure block 248, which is movable 259 in both inward and outward directions relative to the rotor subassembly 261, is also shown in more detail. This movement is described further below.

[0090] In some embodiments, the inlet channel 247, outlet channel 257, inlet guide 244, tube pressurizing block 248, and outlet guide 252 have several main sensors, as shown in Figures 2K1 and 2K2. A pressure sensor 255A is partially shown in the outlet guide 252 and outlet channel 257. In some exemplary embodiments, the pressure sensor 255A may be a centrifuge pressure sensor (i.e., CPS) that engages with a tube in the outlet channel 257 and can measure or determine the pressure of the fluid in it, in this case blood, so that the relative centrifuge pressure can be determined as this fluid is in pressure communication with the fluid in the centrifuge downstream. Also schematically shown in Figure 2K2 are a door closure sensor 255B and one or two moving block position sensors 255C and 255D. The door closure sensor 255B is located in the inlet guide 244, here operably positioned near the hook 245B to sense the closure of the tube guard 240. The door closing sensor 255B may be an inductive sensor or another type of sensor. One or both of the moving block position sensors 255C and / or 255D are located below the tube pressure block 248 and may sense the closing of the tube pressure block 248 relative to the rotor subassembly 261 (moving block position sensor 255D) or the open position of the tube pressure block 248 relative to the rotor subassembly 261 (moving block position sensor 255C). One or both of the moving block position sensors 255C and / or 255D may be employed, and in some embodiments they may be optical sensors triggered by the movement / positioning of the tube pressure block 248.

[0091] The tube pressurizing block 248 may further include a curved surface of the raceway 246 positioned between a first protruding portion 256A and a second protruding portion 256B. The first protruding portion 256A and the second protruding portion 256B may 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 operably engage substantially with the rotary pressure rollers 268. This operable engagement is achieved by moving the tube pressure block 248 in direction 259, allowing the raceway to alternately engage with and disengage from the rotary pressure rollers 268 of the rotor subassembly 261. When engaged with the rotor subassembly 261, the portion of the inlet tube 108B that is blocked by at least one of the rotary 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 rotary pressure rollers 268 to pinch or block the inlet tube 108B against the surface of the raceway 246. In at least one exemplary embodiment, the rolling of the rollers causes the blockage to move along the tube line in either one direction or the other, and the fluid in the tube moves along with the moving blockage. In at least one exemplary embodiment, the rotor subassembly 261 is configured to rotate in both clockwise and counterclockwise directions so that the blockage moves along the inlet tube 108B in either direction.

[0093] These functions and operations are shown, for example, in Figures 2L1 and 2L2. In Figure 2L1, the tube pressure block 248 is shown either moved outward in direction 259A so that the raceway 246 slides open. In this position, there is sufficient space between the rotating pressure roller 268 and the surface of the raceway 246, allowing the un-closed portion of the inlet tube 108B to be positioned between them. In the figure, the inlet tube 108B is also positioned within the inlet channel 247 of the inlet guide 244 and within the outlet channel 257 of the outlet guide 252. The positioning of the tube in and / or between the inlet guide 244, the outlet guide 252, the tube pressure block 248, and the rotating pressure roller 268 is schematically shown to be in a substantially un-closed state, and the thickness dimension or diameter dimension "d" in the un-closed state is shown.

[0094] As shown in Figure 2L2 (slightly exaggerated for conceptual purposes), as the tube pressurizing block 248 moves inward 259B, the raceway 246 engages with the tube, crushing it against the roller 268A (in the figure, some thickness of the inlet tube 108B remains, representing the thickness of the tube sidewall). In some exemplary embodiments, the suction pump 208 may include sidewall functional portions 258A, 258B that assist in maintaining the position of the inlet tube 108B within the suction pump 208 without normally restricting the flow when the inlet tube 108B engages with the suction pump 208. Furthermore, the sidewall functional portions 258A, 258B may function to gradually guide the inlet tube 108B into the raceway 246, thereby preventing abrupt pressure fluctuations when one of the rotating pressurizing rollers 268 contacts the raceway 246 and completely closes the inlet tube 108B. In at least one exemplary embodiment, the positioning of the inlet tube 108B creates a meandering path for the fluid, which makes it more reliable to keep the fluid from moving inside and / or in the tube itself.

[0095] In addition, as described above, when the inlet tube 108B is located within the inlet channel 247 and the outlet channel 257, and the protrusions 249A, 249B, and 249C (not shown in Figures 2L1 and 2L2) are lowered into the recesses 253A, 253B, and 253C and engaged, the protrusions 249A, 249B, and 249C engage with the inlet tube 108B and press the tube substantially non-obstructively in a substantially lateral direction. These are indicated by slightly widened areas of the tube within each of the recesses 253A, 253B, and 253C in Figure 2L2, with a diameter greater than "d". These cooperate to hold the tube in a substantially fixed position for the sensor and for engagement with the rotating pressure roller 268. Furthermore, the cooperation or joint action of one or more of these tube-holding functional parts, such as the inlet channel 247 and the outlet channel 257, with the recesses 253A, 253B, 253C and the protrusions 249A, 249B, 249C and / or the raceway 246 and / or tube pressurizing block 248 adjacent to the rotating pressure roller 268 enables linear loading of the tube, and allows the pump header portion of the inlet tube 108B to be used as the same tube as any and / or all of the other tubes in the line throughout the entire tube set. This eliminates the need for specially developed tubes.

[0096] Figures 2M1 to 2M4 show other views of the intake pump 208. Figure 2M1 is a cross-sectional view of the apheresis system 200 showing other detail parts 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 tube to stretch and tension, thereby preventing the tube from buckling within the apheresis system 200. In at least one exemplary embodiment, the notch 244A may be a sidewall functional portion located at one or both ends of the raceway 246. For example, when a tube is placed in the apheresis system 200, the tube expands and contracts when a pump such as the intake pump 208 is operating. As the inlet tube 108B is stretched, its length increases, and the likelihood of the tube buckling tends to increase. The notch 244A may be configured to allow the tube to stretch by increasing the area on which the tube is stationary, thereby preventing the tube from buckling. The notch 244A can provide additional space for the tubing to expand, allowing for the use of common tubing throughout the apheresis system. As mentioned above, using common tubing within the apheresis system 200 can reduce the costs associated with the apheresis system 200.

[0097] In some exemplary embodiments, the inlet guide 244 may also include a protrusion 244B configured to assist in maintaining the tube in a desired position within the draw-in pump 208. For example, the protrusion 244B may be configured to guide the inlet tube 108B into the raceway 246, which helps to keep the tube within the raceway 246. It should be understood that the outlet guide 252 may also include functional parts similar to the notch 244A and the protrusion 244B.

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

[0099] Referring to Figures 2M3 and 2M4, the fluid ingress prevention portion of the apheresis system 200 is shown. In at least one exemplary embodiment, the fluid ingress prevention portion may be a levee portion 267 surrounding the access point 267A of the internal pump components of the intake pump 208. In at least one exemplary embodiment, the levee portion 267 may be a functional portion of the base member 210A. The levee portion 267 can prevent fluid coming out of any of the tubes passing through the apheresis system 200 from reaching electrical components of the pumps, such as the motors of the intake pump 208, the return pump 212, or the AC pump 216. In at least one exemplary embodiment, the levee portion 267 may be located elsewhere in the apheresis system 200 so as to be configured to capture the fluid before it reaches any electrical components of the pumps in the apheresis system 200.

[0100] Figures 2N and 2O show two exploded views of the tube pressure block 248, which is interconnected with two other components, namely the outlet guide 252 in Figure 2N and the inlet guide 244 in Figure 2O. Here, two wing-like members 269A and 269B of the tube pressure block 248 are shown, which are operably positioned within receiving slots 271A and 271B defined in the inlet guide 244 and the outlet guide 252, respectively. The receiving slots 271A and 271B are elongated laterally, which here is from the inside to the outside of the page. The lateral direction corresponds to direction 259 in Figure 2K1. This allows for the inward and outward movement of the tube pressure block 248 relative to the rotor subassembly 261, as well as relative to the inlet guide 244 and the outlet guide 252. This also ensures that the tube pressurizing block 248 does not move in an undesirable 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 in 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 Figure 2P1, a pneumatic / spring system 290 is shown. Figure 2P1 is a cross-sectional view showing a base member 210A and a tube pressurizing block 248 having 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 coupling 292A, and a pneumatic source tube 292B. The diaphragm member 291 is located inside a cavity 293 defined within the tube pressurizing block 248. The pneumatic coupling 292A and the pneumatic source tube 292B allow air and / or other gases or fluids to move through them, causing the diaphragm to expand or contract. The spring system 290 further includes one or more compression springs 294 and a spring support structure 295. In at least one exemplary embodiment, the spring support structure 295 may be adjacent to or adjacent to the diaphragm member. One or more compression springs 294 and spring support structures 295 are shown in detail in Figure 2P2 in an exploded view of the spring system 290 and the tube pressure block 248. In Figure 2P2, the inlet guide 244 and outlet guide 252 are shown exploded laterally, above, and away from the tube pressure block 248, and the spring system 290 is shown exploded below. The diaphragm member 291 is shown next to the pneumatic fitting 292A and the pneumatic source tube 292B, accompanied by three compression springs 294 and spring support structures 295. In other embodiments, fewer or more compression springs 294 may be provided.

[0102] Schematic diagrams of the diaphragm member 291, the pneumatic coupling 292A, and one or more compression springs 294 are shown in Figures 2Q1 and 2Q2. In Figure 2Q1, the spring system 290 is shown in a cross-sectional view together with the base member 210A and the tube pressure block 248. The tube pressure block 248 here shows an upper edge portion 262 adjacent to the face of the raceway 246, which provides a shelf-like portion for holding the tube downward relative to the face of the raceway 246 to maintain engagement with the rotating pressure 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 located in a cavity 293 defined within the tube pressure block 248. One or more compression springs 294 and a spring support structure 295 may also be located in the cavity 293. Next, in Figure 2Q2, air and / or gas and / or fluid are introduced as indicated by arrow 296A, inflating the diaphragm member 291, pushing the inner wall 293A, moving the tube pressurizing block 248 to an open position away from the rotor subassembly 261 (not shown in Figure 2Q2), and compressing one or more compression springs 294. The distance "x" shown in Figure 2Q2 represents the movement of the tube pressurizing block 248 in direction 297.

[0103] What is shown and described herein is the normally closed (NC) operation, in which the tube pressure block 248 is normally held in a fully engaged position toward the rotor subassembly 261 by one or more compression springs 294, pushing it forward. In at least one exemplary embodiment, the fully engaged position is the position in which the faces of the raceway 246 are positioned adjacent to the rollers such that, when the tube is installed, it is fully pushed and in a fully closed position. One or more compression springs 294 maintain such a position whether or not power is applied to the system. When the apheresis system 200 instructs to open the tube pressure block 248, the pneumatic system is activated to supply driving force to the diaphragm member 291, causing the tube pressure block 248 to move toward the open position relative to the NC, i.e., the normally closed state. This embodiment provides a safety device or check valve action to prevent the apheresis system 200 from attempting to draw or return more blood from the connected donor in the event of a power outage or accidental power interruption, which is a desirable arrangement for a suction pump such as the suction pump 208. When power is lost, the power supply to the solenoid valve that directs pressurized air to the diaphragm member 291 (e.g., a pneumatic actuator) is cut off. When the actuator is exposed to atmospheric pressure, the actuator ceases to apply force to the tube pressurizing block 248 (e.g., a race or raceway), and as a result, one or more compression springs 294 move the tube pressurizing block 248 to a desired safe position (e.g., the NC position), as shown in Figure 2Q1. With a normally closed pump in the NC position, the suction pump 208 acts like a closed valve, not allowing any blood flow in the donor supply tube 104, the cassette inlet tube 108A, or the inlet tube 108B.

[0104] Referring to Figures 2R1 and 2R2, pumps such as the return pump 212, which is in a normally open (NO) configuration, are shown, in contrast to the draw pump 208, which is in a normally closed (NC) configuration. As shown in Figures 2R1 and 2R2, the return pump 212 has a diaphragm, here a diaphragm member 291', and on the other side a spring such as one or more compression springs 294'. In Figure 2R1, the diaphragm member 291' is located inside a cavity 293' defined within the tube pressure block 248'. The spring system 290' is also shown in a cross-sectional view together with the base member 210A' and the tube pressure block 248'. The tube pressure block 248' may include an upper edge portion 262' adjacent to the face of the raceway 246', the upper edge portion 262' being configured to hold the received tube downward relative to the face of the raceway 246'. The internal components of the spring system 290' include a diaphragm member 291' and a pneumatic coupling 292A'. It also includes one or more compression springs 294' and a spring support structure 295'. As shown in Figure 2R2, air and / or gas and / or fluid are introduced at 296A', inflating the diaphragm member 291', pushing the inner wall 293A', and moving the tube pressure block 248' toward the closed position toward the rotor subassembly 261 (not shown in Figure 2R2). The distance "x'" is shown as the distance the tube pressure block 248' moves toward the roller in direction 297'. The closed position here is under pneumatic operation relative to the normally open (NO) configuration of the return pump 212. If 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 saline or plasma to freely return to the centrifuge, depending on the pressure difference, if any.

[0105] Figures 2S1 and 2S2 show a return pump 212. In at least one exemplary embodiment, the return pump 212 may be similar to the intake pump 208. For example, Figures 2S1 and 2S2 show 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 tube portion on the base member 210A' related to the inlet guide 244' and outlet guide 252' and the tube pressure block 248' and the rotor subassembly 261' (under the rotor cover 236') (not shown in Figures 2S1 to 2S2, but see the outlet tube 112 in Figure 2A). The door or tube cover or tube guard 240' is shown herein to include a latch hook subsystem with a latch bar 241', which is shown to be positioned as part of the tube cover or tube guard 240' and / or connected thereto. As described above, the latch bar 241' is pivotable on and / or about the axis 243' relative to the tube guard 240', while the tube guard 240' is pivotable about the axis 242' relative to the inlet guide 244', the outlet guide 252', and the rotor subassembly 261'. Rotary connectors 237A' and 237B' provide this operational relationship. Similar to the structure and function of the draw-in pump 208, the hook 245A' on or connected to the latch bar 241' is initially engaged with the mating hook 245B' of the inlet guide 244', and is disengaged by a manual or similar external force applied to the latch bar 241' as shown in Figure 2G, thereby opening the tube guard 240' as shown in Figures 2H and 2I. To close the tube guard 240', the reverse movement or operation is used.

[0106] As shown in detail in Figure 2S2, the return pump 212 is shown without the rotor cover 236' and tube guard 240'. Thus, the rotor subassembly 261' having the rotating pressure roller 268' is exposed. For clarity, the race or raceway 246', inlet channel 247', outlet channel 257', and associated recesses 253A', 253B', and 253C' for holding the tube within the pump and for sensors are also exposed. The return pump 212 also includes a tube pressure block 248' similar to the tube pressure block 248 of the draw pump 208, which is movable in both directions of arrow 259' relative to the rotor subassembly 261' in this embodiment and various embodiments. In at least one exemplary embodiment, the tube pressure block 248' does not have to be perfectly perpendicular to the tube line but may be positioned at a slight angle Θ' to provide an improved locational finder for the return pump 212. The raceway 246' and the rotating pressure roller 268' interact with each other in substantially the same manner as described above with reference to the draw-in pump 208, so that the tubular portion can be engaged and held in an operable relationship within the return pump 212.

[0107] The inlet channel 247', outlet channel 257', inlet guide 244', tube pressurizing block 248', and outlet guide 252' of the return pump 212 may include one or more sensors. For example, as shown in Figure 2S2, the inlet guide 244' and inlet channel 247' may include a pressure sensor 255A'. The pressure sensor 255A', also known as a centrifuge pressure sensor (i.e., CPS), engages with the tube within the inlet channel 247' to measure or determine the pressure of a fluid, such as blood, within it. Since this fluid is in pressure communication with the fluid in the centrifuge upstream, the relative centrifuge pressure can be determined from the pressure sensor 255A'. In addition, 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 that appropriate action is needed. Figure 2S2 also schematically shows a door closing sensor 255B' and a moving block position sensor 255C'. In at least one exemplary embodiment, the door closing sensor 255B' may be similar to the door closing sensor 255B of the intake pump 208, but here it is located within the outlet guide 252', where it is operably positioned to sense the closing of the door or tube guard 240'. The door closing sensor 255B' may be an induction sensor or other sensor. In at least one exemplary embodiment, the moving block position sensor 255C' may be similar to the moving block position sensors 255C and / or 255D of the intake pump 208, and may be located below the tube pressure block 248' to sense the closing of the tube pressure block 248' relative to the rotor subassembly 261' (sensing the presence of the tube pressure block 248') or to sense the opening of the tube pressure block 248' relative to the rotor subassembly 261' (sensing the absence of the tube pressure block 248').In at least one exemplary embodiment, the pressure sensor 255A' may be similar to one or both of the moving block position sensors 255C and / or 255D of the draw-in pump 208, and in some embodiments, it may be an optical sensor triggered by the movement / positioning of the tube pressurizing block 248'.

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

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

[0110] In addition, the AC pump 216 may be a manual pump and may not have the pneumatic block control provided by the intake pump 208 and return pump 212. Since it may not be optimal for AC to flow freely to the donor 102 during power off or power outages, the AC pump 216 may have a passive spring or similar biasing member to set the raceway in a normally closed position.

[0111] Despite these differences, the AC pump 216 also shares several similarities with both the draw-in pump 208 and / or the return pump 212. For example, in Figures 2T1, 2T2, and 2T3, the AC pump 216 is shown to have a door or tube cover or tube guard 240''. The tube guard covers the tube portion on the base member 210A'' associated with the inlet guide 244'' and outlet guide 252'' and the tube pressure block 248'' and the rotor subassembly 261'' (under the rotor cover 236'') (not shown in Figures 2T1 to 2T3, but see the anticoagulant tube 110 in Figure 2A). The tube guard 240'' is shown herein to have a latch hook subsystem having a latch bar 241'', which is shown to be positioned as part of the tube guard 240'' and / or connected thereto. As described above, the latch bar 241'' is pivotable on and / or about the axis 243'' relative to the tube guard 240'', while the tube guard 240'' is pivotable about the axis 242'' relative to the inlet guide 244'', the outlet guide 252'', and the rotor subassembly 261''. Rotary connectors 237A'' and 237B'' provide this operational relationship. Similar to the structure and function of the intake pump 208 and the return pump 212, the hook 245A'' on or connected to the latch bar 241'' is initially engaged with the fitting hook 245B'' of a guide such as the outlet guide 252'', and is disengaged by a manual or similar external force applied to the latch bar 241'' as shown in Figure 2G, thereby opening the tube guard 240'', similar to the operation shown in Figures 2H and 2I-1 for the intake pump 208. In at least one exemplary embodiment, the tube guard 240'' can be closed by performing the reverse movement or action.

[0112] Figure 2T2 shows the AC pump 216 without the rotor cover 236'' and tube guard 240''. Without the rotor cover 236'' and tube guard 240'', the rotor subassembly 261'' and rotating pressure roller 268'' are illustrated. Furthermore, a race or raceway 246'', inlet channel 247'', and outlet channel 257'', as well as associated recesses 253A'', 253B'', and 253C'', are shown for holding tubes within the pump and for sensors. Similar to the draw pump 208 and return pump 212, the AC pump 216 includes a tube pressure block 248'', which, in this embodiment and various embodiments, is movable in both directions of arrow 259'' relative to the rotor subassembly 261''. In at least one exemplary embodiment, the tube pressure block 248'' does not have to be perpendicular to the tube line, but may be positioned at a slight angle Θ''. This helps to improve the force that holds the tube for the sensor and / or resists rolling motion and resists movement of the raceway 246'' or the tube pressure block 248'' or the tube. The raceway 246'' and the rotating pressure roller 268'' interact with each other and / or with the protruding portions 256A'' and / or 256B'' to engage with and hold the tube portion in an operable relationship within the AC pump 216.

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

[0114] In addition, 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 Figure 2T3, the first cam 273A'' and the second cam 273B'' are coupled to or connected to the tube guard 240''. Thus, the first cam 273A'' and the second cam 273B'' can 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 can couple to or intersect with the raceway 246''. The first cam 273A'' and the second cam 273B'' move together with the tube guard 240'', pushing the raceway 246'' into place. Therefore, the raceway 246'' is in a predetermined position only when the tube guard 240'' is closed, and is held in that position by the force of the spring and the first cam 273A'' and the 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'' with respect to the inlet channel 247''. The first sensor 255A'' may be an air or bubble detector, which is any optical, ultrasonic, or other type of sensor configured to detect the presence of fluid and / or air in the anticoagulant tube 110 of the AC pump 216. In at least one exemplary embodiment, if the first sensor 255A'' detects air or other undesirable contaminants, a suitably modified action may be triggered. In at least one exemplary embodiment, if the first sensor 255A'' detects air or other undesirable contaminants, the AC pump 216 may be stopped. Also schematically shown in Figure 2T2 is a second sensor 255B'', which is a door-close sensor located in the inlet channel 247''. In at least one exemplary embodiment, the first sensor 255A'' may be the same as the pressure sensors 255A and 255A'' of the intake pump 208 and the return pump 212. In at least one exemplary embodiment, the second sensor 255B'' may be the same as the door closing sensor 255B of the intake pump 208, because the second sensor 255B'' may be operably positioned within the inlet guide 244'' to sense the closing of the door or tube guard 240''. In at least one exemplary embodiment, the second sensor 255B'' may be an induction sensor or other sensor, as described above. In at least one exemplary embodiment, the AC pump 216 may include additional sensors (not shown). However, since the tube pressurizing block 248'' is biased only passively by a spring or similar biasing member, additional block sensors similar to the moving block position sensors 255C and / or 255D and / or 255C'' may not be included in the AC pump 216, but may be optionally included in at least one exemplary embodiment.

[0116] In at least one exemplary embodiment, the tube pressure block 248'' is passively pushed into the closed position in the normally closed configuration, so to load the anticoagulant tube 110, the tube pressure block 248'' is opened by hand, or by other manual or external force, so as to pull the tube pressure block 248'' away from the rotor subassembly 261''. Otherwise, a mechanical relationship may be constructed in which the tube pressure block 248'' can be moved backward by lever action away from the rotor subassembly 261'' by mechanically opening the tube guard 240'' around the rotating connectors 237A'' and 237B'' and rotating it upward. This could be one valid reason for positioning the tube guard 240'' in the opposite direction, facing the tube pressure block 248'', as indicated by the arrow in Figure 2T1, rather than away from the tube pressure block 248''. When the tube guard 240'' is opened, it moves the tube pressure block 248'' away from the rotor subassembly 261'', opening the raceway 246'' and allowing the tube to be loaded. Then, in closing, when the force on the tube guard 240'' is released, a spring or similar passive biasing member pushes the raceway 246'' back into an operable normally closed position, and the tube engages with the rotor subassembly 261'' and the rotating pressure roller 268''.

[0117] Referring to Figure 2U, the fluid valve control system 228 of the apheresis system 200 is shown 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 the fluid being transported through the tubing of the apheresis system 200. In at least one exemplary embodiment, the apheresis system 200 includes the fluid valve control system 228 positioned adjacent to the saline bag 118 and / or plasma collection bottle 122.

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

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

[0120] The plasma flow control valve 286 and / or saline flow control valve 288 may be solenoid valves, linear actuators, pinch valves, clamp valves, tubular valves, and / or other operable valves configured to selectively alter (e.g., block) the fluid passage associated with specific portions of the outlet tube 112, saline tube 116, and plasma tube 120. As shown in Figure 2U, the plasma flow control valve 286 may be configured to pinch a portion of the plasma tube 120 that is at least partially housed within the receptive 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 tube 116 that is at least partially housed within the receptive functional portion of the saline-plasma valve housing 276. In any case, the plasma flow control valve 286 and the saline flow control valve 288 include operable and extendable fingers that move from a retracted or partially retracted position to an extended or partially extended position to pinch a portion of the tube housed within the saline-plasma valve housing 276. The plasma flow control valve 286 and the saline flow control valve 288 may pinch the tube completely (for example, completely restrict the flow of fluid through the tube), but it should be understood that the plasma flow control valve 286 and the saline flow control valve 288 may also be partially actuated to a position that partially restricts the flow of fluid in a portion of the tube.

[0121] Furthermore, this specification describes a method 300 for fluid control in a pump. Method 300 is described in relation to a suction pump 208, but it should be understood that method 300 can be performed with a return pump 212 and / or AC pump 216. Method 300 begins with step 302, where a tube is inserted into a pump such as a suction pump 208. As described above, the pump may include an inlet guide such as an inlet guide 244 and an outlet guide such as an outlet guide 252. In at least one exemplary embodiment, the tube is inserted into the suction pump 208 via the inlet guide 244, placed between the raceway 246 and the rotor subassembly 261, and exits via the outlet guide 252. The tube pressurizing block 248 is in a first position when the tube is inserted into the suction pump 208.

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

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

[0124] In at least one exemplary embodiment, the pump may further include a tube guard 240 configured to engage with an inlet guide and an outlet guide. For example, tubes positioned between the tube guard 240 and the inlet guide 244, and tubes positioned between the tube guard 240 and the outlet guide 252, may be clamped in a diamond shape. The tubes are capable of carrying fluid but are 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 extend when the pump is operated. The 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 the operation of the apheresis system 200.

[0126] This specification also describes a method 400 for fluid control via an apheresis system, such as an apheresis system 200. Method 400 begins by proceeding to step 402, where a first pump is operated to draw whole blood from a donor. In at least one exemplary embodiment, the first pump may be a draw-in pump 208. Method 400 then proceeds to step 404, where whole blood from the donor is received via an inlet tube 108B. The inlet tube 108B is fluidly connected to the apheresis system 200. Method 400 then proceeds to step 406, where the whole blood is moved through a first pump of the apheresis system 200. In at least one exemplary embodiment, the whole blood is moved through the draw-in pump 208 to a centrifuge of the apheresis system 200. As described above, in at least one exemplary embodiment, whole blood is moved through the draw-in pump 208 via the rotor subassembly 261. For example, the rotor subassembly 261 begins to rotate such that at least one roller of the rotor subassembly 261 closes the tube, causing the fluid in the tube to move in a direction corresponding to the rotation of the roller and the rotor subassembly 261.

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

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

[0129] Typical systems and methods of apheresis methods and systems of this disclosure have been described. However, to avoid unnecessarily obscuring this disclosure, some known structures and apparatuses have been omitted. This omission should not be construed as limiting the scope of the disclosure as described in the claims. Certain detailed descriptions are provided to give an understanding of this disclosure. However, it should be understood that this disclosure may be carried out in various ways other than those described herein.

[0130] Furthermore, while the embodiments, configurations, and / or configurations illustrated herein represent various components of a system in which it is deployed, specific components of the system may be remotely located in remote parts of a distributed network such as a LAN and / or the Internet, or within a dedicated system. Therefore, it should be understood that components of the system can be combined into one or more devices, or that components of the system can be located at specific nodes in a distributed network such as an analog and / or digital telecommunications network, a packet-switch network, or a circuit-switched network. From the foregoing, it is also understood that, for computational efficiency, components of the system can be located at any location within the distributed network of the components without affecting the operation of the system. For example, various components can be located in a PBX and media server, a switch such as a gateway, one or more communication devices, one or more user sites, or any combination thereof. Similarly, one or more functional parts of the system can be placed between a telecommunications device and associated computer equipment.

[0131] Furthermore, it should be understood that the various links connecting the elements may be wired links or wireless links, or any combination thereof, or any other known or later developed elements capable of supplying and / or communicating data to and from the connected elements. These wired or wireless links may also be secure links and capable of transmitting encrypted information. The transmitting medium used as a link may be any carrier suitable for electrical signals, including, for example, coaxial cables, copper wires, and optical fibers, or it may take the form of sound waves or light waves, such as those generated during radio or infrared data communications.

[0132] Furthermore, while flowcharts have been discussed and illustrated to illustrate specific sequences of events, it should be understood that modifications, additions, and omissions to these sequences can be made without substantially affecting the operation of the disclosed embodiments, configurations, and aspects.

[0133] Multiple variations and modifications of this disclosure can be used. Some features of this disclosure can be provided without giving rise to other features.

[0134] In further other embodiments, the systems and methods of this disclosure may be implemented in connection with a dedicated computer, a programmed microprocessor or microcontroller and peripheral integrated circuit elements, an ASIC or other integrated circuit, a digital signal processor, logic circuits such as hardwired electronic equipment or discrete element circuits, a programmable logic device or gate array, e.g., a PLD, PLA, FPGA, PAL, a dedicated computer, any equivalent means, etc. In general, any apparatus or means capable of implementing the methodologies shown herein may be used to implement various aspects of this disclosure. Typical hardware that may be used for the disclosed embodiments, configurations, and aspects includes computers, portable devices, telephones (e.g., mobile phones, internet-enabled, digital, analog, hybrid, etc.), and other hardware known in the art. Some of these devices include processors (e.g., one or more microprocessors), memory, non-volatile storage devices, 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 implement the methods described herein.

[0135] In further embodiments, the disclosed method can be readily implemented in connection with software using an object or object-oriented software development environment that provides portable source code that can be used on a variety of computer or workstation platforms. Alternatively, the disclosed system can be partially or fully implemented with hardware using standard logic circuits or VLSI designs. Whether software or hardware is used to implement the system relating to this disclosure depends on the system's speed and / or efficiency requirements, specific functions, and the specific software or hardware system or microprocessor or microcomputer system being used.

[0136] In further embodiments, the disclosed method may be partially implemented in software that can be stored on a storage medium and executed on a general-purpose computer, dedicated computer, microprocessor, etc., programmed in cooperation with a controller and memory. In these cases, the system and method of this disclosure may be implemented as a program embedded in a personal computer, such as an applet, JAVA® or CGI script; as a resource residing in a server or computer workstation; as a routine embedded in a dedicated measurement system or system component; or the like. The system may also be implemented by physically embedding the system and / or method into a software and / or hardware system.

[0137] This disclosure describes components and functions implemented in aspects, embodiments, and / or configurations relating to specific standards and protocols, but 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 deemed 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 effective equivalents having substantially the same functionality. Such alternative standards and protocols having the same functionality are deemed to be equivalents included in this disclosure.

[0138] This disclosure of various aspects, embodiments, and / or configurations includes substantially illustrated and described components, methods, processes, systems, and / or devices, including various aspects, embodiments, configuration embodiments, subcombinations, and / or subsets thereof. A person skilled in the art will be able to understand, after understanding this disclosure, how to create and use the disclosed aspects, embodiments, and / or configurations. This disclosure of various aspects, embodiments, and / or configurations includes providing devices and processes in various aspects, embodiments, and / or configurations, for example, in the absence of items that may have been used in prior devices or processes, in the absence of items not illustrated and / or described herein, or in the absence of items in those various aspects, embodiments, and / or configurations, including in the absence of items that may have been used in prior devices or processes, in order to improve performance, obtain ease, and / or reduce implementation costs.

[0139] The above description has been given for illustrative and explanatory purposes. It is not intended to limit the disclosure to one or more forms disclosed herein. For example, in the above detailed description, various features of the disclosure are grouped together in one or more aspects, embodiments, and / or configurations for the purpose of simplifying 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 should not be interpreted as reflecting an intention that the claims require more features than those explicitly enumerated in each claim. Rather, as reflected in the following claims, the aspects of the invention have fewer features than all the features of the single disclosed aspect, embodiment, and / or configuration described above. Accordingly, the following claims are incorporated into this detailed description, and each claim exists on its own as a separate preferred embodiment of the disclosure.

[0140] Furthermore, while the text of the specification has included descriptions of one or more aspects, embodiments, and / or configurations, and specific variations and modifications, other variations, combinations, and modifications may be within the scope of the disclosure, for example, within the scope of the skills and knowledge of a person skilled in the art, after understanding the disclosure. It seeks to obtain, to the extent permitted, rights including other aspects, embodiments, and / or configurations, including substitute and / or equivalent structures, functions, scopes, or steps, whether or not such substitute and / or equivalent structures, functions, scopes, or steps are disclosed herein, and without intending to publicly use any patentable subject matter.

Claims

1. A pump for fluids, the pump is A rotor subassembly that accommodates at least one roller, A tube pressurizing block having a raceway and at least one projection, and movable between a first position and a second position, An inlet guide having an inlet channel and positioned close to the first side of the tube pressurizing block, An outlet guide having an outlet channel and positioned adjacent to the second side of the tube pressure block, wherein the second side of the tube pressure block is opposite to the first side of the tube pressure block such that a substantially linear path is formed between the inlet guide and the outlet guide and a tube extends along the substantially linear path between the inlet guide and the outlet guide, A tube guard configured to engage with 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 pressure block, the inlet guide, and the outlet guide when the tube guard is in an open position, Equipped with, The tube pressurizing block further comprises a cavity including at least one biasing member configured to maintain the tube pressurizing block in at least one of the first or second positions, and at least one driven operating member disposed within the cavity, wherein the at least one driven operating member is configured to overcome the force of the at least one biasing member. The at least one driven operating member is a pneumatic diaphragm, which is configured to expand to move the tube pressurizing block away from the first or second position. A pump for fluids.

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

3. The pump according to claim 1, wherein the pump is configured to engage with a portion of the tube that is arranged via the inlet guide, the raceway and the outlet guide, pump.

4. In the pump according to claim 3, the portion of the tube is configured to be closed when the tube pressurizing block is in the second position. pump.

5. In the pump according to claim 4, the at least one roller is configured to engage with the portion of the tube and close the tube when the tube pressurizing block is in the second position. pump.

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

7. In the pump according to claim 6, the at least one channel projection is configured to engage with the 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, thereby partially closing the portion of the tube. pump.

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

9. The pump according to claim 3, wherein the portion of the tube is configured to extend when the pump is in operation, and the raceway comprises at least one sidewall functional portion configured to collect the extended portion of the portion of the tube, pump.

10. The pump according to claim 1, further comprising at least one sensor positioned in close proximity to at least one of the inlet guide, the outlet guide, or the tube pressurizing block, pump.

11. In the pump according to claim 10, 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 induction sensor, an optical sensor, a light sensor, an ultrasonic sensor, or an air or fluid sensor. pump.

12. In the pump according to claim 1, the at least one biasing member is at least one spring. pump.

13. The pump according to claim 1, wherein the pump is a normally closed pump, the first position is a closed position, 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 the force of the at least one biasing member and move the tube pressurizing block to the second position. pump.

14. The pump according to claim 1, wherein the pump is a normally open type pump, the first position is a closed position, 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 the force of the at least one biasing member and move the tube pressurizing block to the first position. pump.

15. In the pump according to claim 1, the pump is an anticoagulant pump, and the first position is the closed position. pump.

16. In the pump according to claim 15, 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.

17. The pump according to claim 1, further comprising a fluid ingress prevention function configured to collect fluid and prevent the fluid from coming into contact with at least one internal pump component, pump.

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