CELL PROCESSING SYSTEM AND METHOD WITH PROCESS PARAMETER CONTROL

A cell processing system includes a processor to receive a biological fluid to be processed, a controller coupled to the processor, the controller configured to operate the processor according to at least one modifiable process parameter, and at least one input coupled to the controller, the at least one input configured to receive an identifier and at least one process parameter control associated with the at least one process parameter that limits modification of the at least one process parameter if applied. The controller is configured to determine if the identifier is associated with an administrator authorization and to apply the at least one processor parameter control to the at least one process parameter if the identifier is associated with an administrator authorization.

Membrane separation devices, systems and methods employing same, and data management systems and methods

A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

System and Method for Creating Sterile Connections Using Ultraviolet Light

A device for connecting first and second medical fluid flow systems includes a linear movement carriage system that is positioned within a housing. The carriage system includes first and second connector holders configured to hold first and second connectors of the first and second medical fluid flow systems, respectively. A coupler holder is configured to hold a coupler and is positioned substantially between the first and second connector holders. The first and second connector holders and the coupler holder are relatively moveable between a separated configuration, where the first and second connectors and the coupler are located in relatively spaced apart positions, and a joined configuration, where the first and second connectors engage the coupler. An ultraviolet light source is positioned in the housing so as to irradiate first and second connectors and the coupler. A drive system transitions the first and second connector holders and the coupler holder between the separated and the joined configurations. 1. A device for connecting first and second medical fluid flow systems , each of which includes , respectively , first and second connectors connectable to a coupler , the device comprising:a. a housing that is substantially non-transmissive of ultraviolet light; i) a separated configuration where the first and second connector holders and the coupler holder are located in relatively spaced apart positions so that first and second connectors held by the first and second connector holders are spaced apart from a coupler held by the coupler holder; and', 'ii) a joined configuration where the first and second connector holders are positioned more closely to the coupler holder than when in the separated configuration so that the first and second connectors held by the first and second connector holders engage the coupler held by the coupler holder;, 'b. a linear movement carriage system positioned within the housing and including a first connector holder ...

METHOD FOR CONTROLLING FOULING AND COMPLEMENT PROTEIN ACTIVATION DURING SPINNING MEMBRANE FILTRATION OF PLASMA FROM WHOLE BLOOD

A system and method are provided for controlling fouling and complement protein activation during separation of plasma from whole blood using a spinning membrane separator. The separator includes a pair of relatively rotating surfaces spaced apart to define a gap therebetween, with at least one of the surfaces comprising a membrane that allows plasma to pass therethrough but substantially prevents the passage of red cells. In accordance with the method, the membrane material and membrane fabrication technique are selected so as that the resulting membrane both resists fouling and complement protein activation. In a specific embodiment, the membrane is has a smooth surface and substantially linear pores. The pores have a nominal diameter of less than 2 microns (so as to exclude platelets) and preferably a diameter of from 0.6 microns to 0.8 microns, as may be obtained by use of track-etching. In addition, the membrane material preferably is polycarbonate, as it has been determined that polycarbonate does not activate complement proteins. 1. An automated whole blood separation system comprising a disposable fluid flow circuit and a durable controller configured to cooperate with and control flow through the fluid circuit , the disposable fluid circuit comprising:a whole blood fluid flow path with a whole blood inlet for connection to a source of whole blood;a separator including outer housing and inner rotor mounted within the housing for rotation relative to the housing, a gap being defined between an outer surface of the rotor and an inner surface of the housing, at least one of the outer surface of the rotor or inner surface of the housing comprising a filter membrane configured to allow the passage of plasma therethrough while substantially blocking cellular components, the membrane having a smooth surface and substantially linear pores with a nominal diameter of 2.0 microns or less, the outer housing including an inlet in fluid communication with the whole blood ...

Membrane separation devices, systems and methods employing same, and data management systems and methods

A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

Membrane separation devices, systems and methods employing same and data management systems and methods

A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

Membrane separation devices, systems and methods employing same, and data management systems and methods

A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

Device and method for processing and producing autologous platelet-rich plasma

A system and method are provided, including an integrated single-use kit, for processing whole blood to produce platelet rich plasma. A two stage spinning membrane separator, has a first stage for receiving whole blood and separating substantially all red blood cells from plasma and platelets, and a second stage for further separating platelet rich plasma from plasma. A first waste container is in fluid communication with the first stage of the separator for receiving separated red blood cells, while a second waste container is in fluid communication with the second stage of the separator for receiving separated plasma. An outlet line is in fluid communication with the second stage of the separator for receiving platelet rich plasma, and a reinfusion container is removably connected to the outlet line for receiving platelet rich plasma from the second stage of the separator.

Membrane separation devices, systems and methods employing same and data management systems and methods

A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

CELL WASHING SYSTEM AND METHODS FOR WASHING SMALL VOLUMES OF CELLS

A fluid circuit for cell washing is provided that comprises a spinning membrane separator and a fluid management system comprising a cassette that defines the fluid pathways, and including internally mechanical valving, pressure sensing and air sensing for controlling flow through the fluid pathways, thus minimizing the volume of the fluid circuit. Additionally, the fluid circuit comprises syringes that are acted on by syringe pumps associated with the hardware component of the system to provide pressure for moving fluid through the circuit. Preferably, the syringes are connected directly to the cassette, or formed integrally within the cassette housing, thus further minimizing the volume of the fluid circuit.

Systems and methods for single needle continuous plasma processing

Certain examples describe systems and methods for increasing plasma extracted from donor blood. An example method includes receiving blood extracted from a donor connected to a blood collection machine. The example method includes filtering the blood using a filtration device to remove at least a portion of plasma included in the blood to separate the plasma removed from remaining blood. The example method includes routing the plasma removed for collection. The example method includes re-filtering the remaining blood using a or the filtration device to remove additional plasma from the remaining blood. The example method includes routing the additional plasma removed for collection.

MEMBRANE SEPARATION DEVICES, SYSTEMS AND METHODS EMPLOYING SAME, AND DATA MANAGEMENT SYSTEMS AND METHODS

A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed. 1. An automated whole blood separation system comprising a disposable fluid flow circuit and a durable controller configured to cooperate with and control flow through the fluid circuit , the disposable fluid circuit comprising:a whole blood fluid flow path with a whole blood inlet for connection to a unit of whole blood;a cell preservation solution flow path with an inlet for connection to a source of cell preservation solution;a separator including outer housing and inner rotor mounted within the housing for rotation relative to the housing, a gap being defined between an outer surface of the rotor and an inner surface of the housing, at least one of the outer surface of the rotor or inner surface of the housing comprising a filter membrane configured to allow the passage of plasma therethrough while substantially blocking red cells, the outer housing including an inlet in fluid communication with the whole blood and/or cell preservation solution flow paths and in flow communication with the gap for directing whole blood and/or cell preservation solution into the gap, the ...

MEMBRANE SEPARATION DEVICES, SYSTEMS AND METHODS EMPLOYING SAME, AND DATA MANAGEMENT SYSTEMS AND METHODS

A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed. 1. A method for priming a spinning membrane separator in which the separator comprises a housing with a top and a bottom , at least one port adjacent each of the top and the bottom of the housing , and a membrane configured to spin about a generally vertically-oriented axis , the method comprising:introducing a priming solution through the port at the bottom of the housing;flowing additional priming solution through the port at the bottom of the housing so that a priming solution-air interface is formed that advances upwardly through the housing to displace air within the housing and to expel the air through the port at the top of the housing, and to simultaneously wet the membrane; andcontinuing to flow additional priming solution through the port at the bottom of the housing until the fluid-air interface has advanced vertically across the entire membrane.2. The method of wherein the priming solution comprises a low-viscosity non-biological fluid.3. A method of wherein the priming solution comprises whole blood.4. A method for priming a membrane separator in which the separator ...

Membrane separation devices, systems and methods employing same and data management systems and methods

A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

MEMBRANE SEPARATION DEVICES, SYSTEMS AND METHODS EMPLOYING SAME, AND DATA MANAGEMENT SYSTEMS AND METHODS

A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed. 1. A single pass automated blood collection system for collecting red blood cells and plasma from a donor comprising:a reusable hardware component; anda pre-assembled disposable fluid circuit component configured to interface with the hardware component, the disposable component comprising:a donor access device for withdrawing whole blood from a donor;a source of anticoagulant communicating with the donor access device;a blood separation device communicating with the access device and employing relatively rotating surface, at least one of which carries a membrane substantially permeable to plasma and substantially impermeable to red blood cells to separate the whole blood into substantially concentrated red cells and plasma;a first collection container communicating with the blood separation chamber for receipt of the substantially concentrated red blood cells;a source of preservative solution communicating with the first collection container; anda second collection container communicating with the blood separation chamber for receipt of the plasma.2. The automated blood ...

MEMBRANE SEPARATION DEVICES, SYSTEMS AND METHODS EMPLOYING SAME AND DATA MANAGEMENT SYSTEMS AND METHODS

A membrane separation device for use in blood processing procedures is disclosed. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the spinning membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib or ridge associated with the spinning membrane that decreases the gap between the spinning membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into selected blood components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed. 1. A blood filtration device comprising:a generally cylindrical housing having an interior wall;an interior member mounted interior of the housing and having an external surface;the interior wall of the housing and/or the external surface of the interior member including a porous membrane spaced apart from the facing wall of the housing or surface of the interior member so as to define an annular gap therebetween;the housing and interior member being relatively rotatable;an inlet for directing whole blood comprising plasma and red cells into the annular gap;a first outlet for directing plasma passing through the membrane to a collection container; anda second outlet for directing from the annular gap the remaining blood components;wherein the membrane has a surface area sufficient to separate plasma at a flow rate resulting in the residence time of red blood cells within the annular gap being insufficient to cause undue hemolysis.2. The blood filtration device of wherein the interior member has a diameter greater than the diameter of the inner member of prior art devices ...

FILL AND FINISH SYSTEMS AND METHODS

A variety of fill options is provided for a cell processing system. Certain options relate to a filling system associated with the cell processing system, the filling system comprising one or more filling stations, each with at least one container that may receive product from a container associated with a cell processing system. Other options relate to a syringe assembly that receives a product from a container associated with a cell processing system. 1. A filling system comprising:a transfer set connectable to a source container;a plurality of filling stations each comprising at least one flexible walled container connected to the transfer set and in selective fluid communication with the source container via the transfer set;a syringe pump connected to the transfer set, and configured to transfer a product from the source container to the at least one flexible walled container via the transfer set; anda controller coupled to the plurality of filling stations and the syringe pump, the controller configured to operate each of the plurality of filling stations and the syringe pump in concert to transfer a constant volume of fluid from the source container to the at least one container of each of the plurality of filling stations.2. The filling system according to claim 1 , wherein the controller is configured to operate the syringe pump to correct for variances in distance between the syringe pump and each of the plurality of filling stations.3. The filling system according to claim 1 , wherein:each of the plurality of filling stations comprises a valve that limits or permits fluid communication between the at least one container and the source container, and the controller being configured to open the valve associated with one of the plurality of filling stations, to operate the syringe pump to transfer the constant volume of fluid from the source container to the at least one container of the one of the plurality of filling stations, and to close the valve ...

SYSTEM AND METHOD FOR SELECTING AND CULTURING CELLS

A cell processing system includes at least one processor connectable to a source container filled with a biological fluid, the processor including a spinning membrane configured to receive and separate target cells from the biological fluid, the target cells exiting at a first outlet, first and second containers selectively connected to the first outlet; and a magnet. The system also includes a controller configured to operate the spinning membrane to receive biological fluid and to direct the target cells to the first container, to pause to permit magnetic particles to be associated with the target cells in the first container, to operate the spinning membrane to receive the contents of the first container with the magnet applied to the target cells associated with the magnetic particles, to remove or deactivate the magnet, and to transfer the target cells to the second container. 1. A cell processing system comprising: a spinning membrane configured to receive and separate target cells from the biological fluid, the target cells exiting at a first outlet;', 'at least a first container and a second container selectively connected to the first outlet; and', 'a magnet; and, 'at least one processor connectable to a source container filled with a biological fluid, the at least one processor comprising to operate the spinning membrane to receive biological fluid from the source container and to direct the target cells to the first container;', 'to pause operation of the processor to permit magnetic particles to be associated with the target cells in the first container;', 'to operate the spinning membrane to receive the contents of the first container with the magnet applied to the target cells associated with the magnetic particles in the first container;', 'to remove and/or deactivate the magnet applied to the target cells associated with the magnetic particles in the first container;', 'to transfer the target cells to the second container after removal and/or ...

SYSTEMS AND METHODS FOR CONCENTRATING CELLS WITH A SYRINGE AND A CENTRIFUGE

A system for concentrating cells, wherein a syringe comprises a lumen and an axial end comprising a port and a radial end closed to liquid flow. A plunger divides the axial and radial ends, and the syringe is configured to hold a cellular suspension. A filter disposed at the radial end is configured to maintain sterility of the syringe. A cap comprises a vent disposed at the radial end. The plunger is configured to be actuated towards the axial end by air pressure being applied into the radial end and the plunger is configured to be actuated towards the radial end by a vacuum being applied into the radial end. 1. A system for concentrating cells , comprising:a syringe comprising a lumen and an axial end comprising a port and a radial end closed to liquid flow, wherein a plunger divides the axial and radial ends, and wherein the syringe is configured to hold a cellular suspension;a filter disposed at the radial end configured to maintain sterility of the syringe;a cap comprising a vent disposed at the radial end;wherein the plunger is configured to be actuated towards the axial end by air pressure being applied into the radial end and the plunger is configured to be actuated towards the radial end by a vacuum being applied into the radial end.2. The system of claim 1 , further comprising an actuator handle configured for attachment with a radial side of the plunger for actuation using a solid contact force claim 1 , and wherein the filter and the cap are removable from the radial end of the syringe.3. The system of claim 1 , wherein the plunger comprises a visible indicator indicative of a relative position of the plunger between the axial and radial ends.4. The system of claim 1 , wherein the lumen of the syringe comprises a capacity of 50-60 mL.5. The system of claim 1 , further comprising a syringe holder configured to fit in a cavity of a centrifuge rotor having an axis of rotation claim 1 , wherein the syringe holder is configured to receive the syringe ...

Flexible Impeller Pumps And Disposable Fluid Flow Circuits Incorporating Such Pumps

A disposable fluid pump is provided with a housing including first and second faces, with a sidewall extending between the first and second faces. The housing defines a chamber, with an inlet and an outlet in fluid communication with the chamber. An impeller is rotatably mounted within the chamber and includes a plurality of flexible vanes. Such a pump may be incorporated into a disposable fluid flow circuit that is adapted to be mounted on a durable hardware for processing a fluid. In such a fluid flow circuit, the fluid pump may be integrated into a cassette of the circuit or, alternatively, the inlet and outlet of the fluid pump may be directly connected to fluid flow conduits of the circuit. 1. A disposable fluid pump comprising:a housing including first and second faces and a sidewall extending between the first and second faces, the housing defining a chamber and an inlet and an outlet in fluid communication with the chamber; andan impeller rotatably mounted within the chamber and including a plurality of flexible vanes.24-. (canceled)5. The disposable fluid pump of claim 1 , whereinthe chamber and the impeller are present in a plane, andat least one of the inlet and outlet extends from the chamber to the sidewall at a location within the same plane in which the chamber and the impeller are present.6. The disposable fluid pump of claim 1 , whereinthe chamber and the impeller are present in a plane, andat least one of the inlet and outlet extends from the chamber to the sidewall at a location in a different plane than the plane in which the chamber and the impeller are present.7. The disposable fluid pump of claim 1 , whereinone of the first and second faces of the housing defines an opening, andthe impeller includes a rigid hub associated with the flexible vanes and defining a socket accessible through said opening and configured to receive a shaft for rotation of the impeller within the chamber.8. The disposable fluid pump of claim 1 , whereinthe impeller ...

CELL PROCESSING SYSTEM AND METHOD WITH CENTRALIZED DATA MANAGEMENT, MONITORING AND/OR CONTROL

A network of cell processing systems including a plurality of cell processing instruments and a server computer. Each cell processing instrument includes a control circuit configured to operate the cell processing instrument according to a modifiable process parameter, a component of the cell processing instrument and a sensor configured to measure a characteristic of the component. The server computer is disposed remotely from the cell processing instruments, and is configured to transmit a request message for a value measured by the sensor, receive a response message based on the request message, and generate a notification message based on the response message. 1. A network of cell processing systems , comprising: a controller configured to operate the cell processing system according to a modifiable process parameter,', 'a component of the cell processing system; and', 'a sensor configured to measure a characteristic of the component; and, 'a plurality of cell processing systems, each cell processing system comprising transmit a request message for a value measured by the sensor;', 'receive a response message based on the request message; and', 'generate a notification message based on the response message., 'a server computer disposed remotely from the cell processing systems, wherein the server computer is configured to2. The network of cell processing systems of claim 1 , wherein the component is a scale configured to weigh a fluid used by the cell processing system.3. The network of cell processing systems of claim 2 , wherein the characteristic is a weight value claim 2 , wherein the server computer is configured to receive the weigh value in the response message claim 2 , to compare the weight value to a predetermined tolerance claim 2 , and to generate a notification message indicating the weight value is out of tolerance.4. A system of cell processing systems with centralized control claim 2 , the system comprising: a processor to receive a biological ...

SMALL VOLUME PROCESSING SYSTEMS AND METHODS

A fluid processing system includes a disposable fluid circuit and reusable hardware configured to accept the disposable fluid circuit. The disposable fluid circuit includes a spinning membrane separator, first and second syringes, and a flow control cassette. The reusable hardware includes a spinning membrane separator drive coupled to the spinning membrane separator, first and second syringe pumps coupled to the first and second syringes respectively, a control cassette interface coupled to the flow control cassette, and at least one controller coupled to the spinning membrane separator drive, the first and second syringe pumps, and the control cassette interface. The controller is configured to selectively operate the drive, the first and second syringe pumps, and the interface to provide a procedure according to a protocol. 1. A fluid processing system comprising: a spinning membrane separator having an inlet, a retentate outlet, and a filtrate outlet;', 'first and second syringes; and', 'a flow control cassette comprising a housing containing a plurality of separate channels connected at a plurality of selectable junctions, each of the selectable junctions selectively connecting at least two of the plurality of channels, the channels and selectable junctions defining at least a first path between a source container, the spinning membrane inlet, the filtrate outlet and the first syringe, a second path between the first syringe and a filtrate container, and a third path between a wash media container, the spinning membrane inlet, the retentate outlet and the second syringe; and, 'a disposable fluid circuit comprisingreusable hardware configured to accept the disposable fluid circuit and comprising:a spinning membrane separator drive coupled to the spinning membrane separator;first and second syringe pumps, the first and second syringes coupled to the first and second syringe pumps respectively, the first syringe pump configured to move a piston within the first ...

Magnet-Based Systems And Methods For Transferring Fluid

A system is provided for pumping fluid, with the system including a fluid pump and a cassette. The pump includes a motor and a piston that is movable toward and away from a flexible diaphragm of the cassette. A linkage connects the motor and the piston to move the piston toward and away from the diaphragm. At least a portion of the piston or the diaphragm is magnetized, with the other having at least a portion that is magnetized or formed of a ferromagnetic material, thereby magnetically coupling the piston and the diaphragm such that movement of the piston moves the diaphragm into and out of a cassette cavity aligned with the diaphragm and piston. Movement of the diaphragm into and out of the cavity changes the effective volume of the cavity, which has the effect of drawing fluid into or forcing fluid out of the cavity. 1. A fluid pump for use in combination with a fluid processing cassette including a flexible diaphragm , the fluid pump comprising:a motor;a piston movable toward and away from the flexible diaphragm of the fluid processing cassette; anda linkage connecting the motor and the piston, wherein the motor functions to move the piston toward and away from the flexible diaphragm of the fluid processing cassette, and wherein at least a portion of the piston or the flexible diaphragm is magnetized and at least a portion of the other one of the piston and the flexible diaphragm is magnetized or formed of a ferromagnetic material so as to magnetically couple the piston and the flexible diaphragm.2. The fluid pump of claim 1 , wherein said linkage comprises a connecting rod connected to the piston and a crankshaft connected to the connecting rod and to a driveshaft of the motor.3. The fluid pump of claim 1 , wherein said linkage comprisesa follower connected to the piston, anda cam connected to a driveshaft of the motor, with the follower positioned in contact with the cam.4. The fluid pump of claim 3 , further comprising a spring biasing the follower into ...

Systems and methods for automated recovery of white blood cells after producing a leuko-reduced blood product

The present disclosure relates to systems and methods for the separation of blood into blood products and, more particularly, to systems and methods that permit automated recovery of white blood cells after producing a leukocyte-reduced blood product.

SYRINGE WITH SYRINGE CLOSURE

A syringe including a barrel, a plunger, and a vented closure. The barrel has a bore, and an end with an opening in communication with the bore and a barrel flange disposed outwardly of the opening. The plunger is disposed in the bore, and is movable along the bore. The vented closure is attached to the barrel at the end, and includes a stopper, a cap and a filter. The stopper is disposed over and/or in the opening in communication with the bore. The cap includes a body disposed over the stopper, and a fastener engaged with the barrel flange. The filter is disposed between the stopper and the cap, or in at least one of the stopper and the cap. 1. A syringe comprising:a barrel with a bore, the barrel having an end with an opening in communication with the bore and a barrel flange disposed outwardly of the opening;a plunger disposed in the bore, the plunger movable along the bore; anda vented closure attached to the barrel at the end, the closure comprising a stopper, a cap and a filter,the stopper disposed over or in the opening in communication with the bore,the cap having a body disposed over the stopper, and a fastener engaged with the barrel flange,the filter disposed between the stopper and the cap, or in at least one of the stopper and the cap.2. The syringe according to claim 1 , wherein the barrel flange comprises a collar disposed on the barrel at the end thereof.3. The syringe according to claim 1 , wherein the stopper comprises an elastomeric stopper with a plug disposed within the bore and a stopper flange depending from an end of the stopper outside the bore.4. The syringe according to claim 3 , wherein the cap secures the stopper flange between the body of the cap and the barrel flange.5. The syringe according to claim 1 , wherein the fastener comprises a downwardly depending skirt having a barb that engages the barrel flange.6. The syringe according to claim 5 , wherein the barb has a surface that abuts a surface of the barrel flange to engage the ...

DEVICE AND METHOD FOR PROCESSING AND PRODUCING AUTOLOGOUS PLATELET-RICH PLASMA

A system and method are provided, including an integrated single-use kit, for processing whole blood to produce platelet rich plasma. A two stage spinning membrane separator, has a first stage for receiving whole blood and separating substantially all red blood cells from plasma and platelets, and a second stage for further separating platelet rich plasma from plasma. A first waste container is in fluid communication with the first stage of the separator for receiving separated red blood cells, while a second waste container is in fluid communication with the second stage of the separator for receiving separated plasma. An outlet line is in fluid communication with the second stage of the separator for receiving platelet rich plasma, and a reinfusion container is removably connected to the outlet line for receiving platelet rich plasma from the second stage of the separator. 1. A closed , preassembled and pre-sterilized apparatus for batch processing of blood to provide a concentrated platelet product , comprising:a blood inlet;a first gap defined between spaced-apart first inner and first outer relatively rotatable surfaces, the first gap being in fluid communication with the inlet and at least one of the first inner and first outer surfaces comprising a first filter membrane that substantially blocks red blood cells from passing therethrough, while allowing platelets and plasma to pass therethrough;a second gap defined between spaced-apart second inner and second outer relatively rotatable surfaces, at least one of the second inner and second outer comprising a second filter membrane that substantially blocks platelets from passing therethrough while allowing plasma to pass therethrough;the apparatus being configured so that the second gap receives plasma and platelets passing through the first filter membrane;a drive assembly for causing relative rotational movement between the first inner and first outer surfaces and between the second inner and second outer ...

Systems and Methods for Processing Large Volumes of Biological Fluid

Automated systems and methods for processing a biological cell suspension are disclosed. The systems and methods allow for the processing of large volumes of a biological cell suspension contained in or more source containers. 1. A system for processing biological cell suspensions comprising a:a) a disposable fluid circuit including a separation device, a fluid flow path in flow communication with said separation device and one more fluid access devices for establishing fluid communication between said flow path and one or more containers of a biological cell suspensions; i. to receive a processing parameter comprising the total volume of biological cell suspension to be processed from one or more source containers;', 'ii. to receive a processing parameter comprising the concentration of cells in said one or more source containers;', 'iii. to calculate the number of draws from said one or more source containers and the volume of each said draw., 'b) a reusable hardware unit comprising a separation device drive unit for receiving said separation device, an operator input and a controller coupled to said input, the controller configured2. The system of wherein said controller is further configured to receive a processing parameter comprising a final targeted cell concentration and wherein said controller is configured to calculate the number and volume of draws based at least in part on said targeted cell concentration.3. The system of wherein said controller is configured to receive a processing parameter comprising the volume of said biological cell suspension to be processed and the number of biological cell suspension source containers.4. The system of wherein said controller is configured to receive a processing parameter comprising the number of a plurality of biological cell source containers claim 1 , the volume of each of said plurality of source containers and the concentration of biological cells in each of said plurality of source containers.5. The system ...

SMALL VOLUME PROCESSING SYSTEMS AND METHODS WITH CAPACITIVE SENSING

A fluid processing system may include a flow control cassette comprising at least one interface sensor chamber in fluid communication with at least one of a plurality of separate channels, the at least one interface sensor chamber defined at least in part by a wall, and at least one capacitive sensor disposed on the wall of the at least one interface sensor chamber. The fluid processing system may include, in the alternative or in addition, at least one syringe comprising a wall defining a barrel having a first end and a second end, the barrel having a bore with or without a piston or plunger disposed therein, and at least one capacitive sensor disposed on an outer surface of the wall of the syringe. 1. A fluid processing system comprising: a separation chamber; and', 'a flow control cassette comprising a housing containing a plurality of separate channels connected to a plurality of selectable junctions, at least one interface sensor chamber in fluid communication with at least one of the plurality of separate channels, the at least one interface sensor chamber defined at least in part by a wall, and at least one capacitive sensor disposed on the wall of the at least one interface sensor chamber; and, 'a disposable fluid circuit comprising a separator connected to the separation chamber;', 'a control cassette interface having at least one actuator for each of the selectable junctions and a coupling connected to the at least one capacitive sensor; and', 'at least one controller coupled to the separator, the at least one actuator and the capacitive sensor via the coupling, the controller configured to selectively operate the separator and the at least one actuator to provide a procedure according to a protocol., 'reusable hardware configured to accept the disposable fluid circuit and comprising2. The fluid processing system according to claim 1 , wherein the at least one capacitive sensor comprises a flexible circuit.3. The fluid processing system according to claim ...

SMALL VOLUME PROCESSING SYSTEMS AND METHODS WITH CAPACITIVE SENSING

A fluid processing system may include a flow control cassette comprising at least one interface sensor chamber in fluid communication with at least one of a plurality of separate channels, the at least one interface sensor chamber defined at least in part by a wall, and at least one capacitive sensor disposed on the wall of the at least one interface sensor chamber. The fluid processing system may include, in the alternative or in addition, at least one syringe comprising a wall defining a barrel having a first end and a second end, the barrel having a bore with or without a piston or plunger disposed therein, and at least one capacitive sensor disposed on an outer surface of the wall of the syringe. 1. A fluid processing system comprising: a separation chamber;', 'at least one plungerless syringe, the syringe comprising a wall defining a barrel having a first end and a second end, the barrel having a bore without a plunger disposed therein, and at least one capacitive sensor disposed on an outer surface of the wall of the syringe; and', 'a flow control cassette comprising a housing containing a plurality of separate channels connected to a plurality of selectable junctions, at least one of the plurality of separate channels connected to the first end of the barrel of the at least one plungerless syringe; and, 'a disposable fluid circuit comprising a separator connected to the separation chamber;', 'at least one syringe pump, the second end of the barrel of the at least one syringe coupled to the at least one syringe pump, the at least one syringe pump configured to draw fluid into and push fluid from the at least one syringe;', 'a control cassette interface having at least one actuator for each of the selectable junctions and a coupling connected to the at least one capacitive sensor; and', 'at least one controller coupled to the separator, the at least one syringe pump and the control cassette interface, the controller configured to selectively operate the ...

Blood Component Pooling Device, System and Method

A device for pooling a blood component stored in source containers includes a pump or pumps configured to pump a fluid in a first direction and a second direction and receive a pump line having a first end connected to the source containers. A pool clamp is configured to receive a pool line having a first end connected to a second end of the pump line and a second end connected to a pool container. A wash clamp is configured to receive a wash line having a first end connected to the second end of the pump line and a second end connected to a wash media container. A controller is configured to open the pool clamp, close the wash clamp and operate the pump in the first direction and to alternatively close the pool clamp, open the wash clamp and operate the pump in the second direction. 1. A device for pooling a blood component stored in a plurality of source containers comprising:a. a pump or pumps configured to pump a fluid in a first direction and a second direction, said pump or pumps configured to receive a pump line having a first end connected to the plurality of source containers;b. a pool clamp configured to receive a pool line having a first end connected to a second end of the pump line and a second end connected to a pool container;c. a wash clamp configured to receive a wash line having a first end connected to the second end of the pump line and a second end connected to a wash media container;d. a controller in communication with the pump or pumps, the pool clamp and the wash clamp, said controller configured to open the pool clamp, close the wash clamp and operate the pump in the first direction and to alternatively close the pool clamp, open the wash clamp and operate the pump in the second direction.2. The device of wherein the pump or pumps are configured to removably receive the pump line claim 1 , the pool clamp is configured to removably receive the pool line and the wash clamp is configured to removably receive the wash line.3. The device of ...

Fill and finish systems and methods

A variety of fill options is provided for a cell processing system. Certain options relate to a filling system associated with the cell processing system, the filling system comprising one or more filling stations, each with at least one container that may receive product from a container associated with a cell processing system. Other options relate to a syringe assembly that receives a product from a container associated with a cell processing system.

SYSTEM FOR WASHING RED BLOOD CELLS TO REDUCE HEMOLYSIS

A system for washing red blood cells, comprising a separator configured to separate a quantity of blood into concentrated red blood cells having a hematocrit of at least 60% and a volume of 150-250 mL, and a supernatant component. The system comprises a flow controller configured to remove the supernatant component to provide an initial red blood cell concentrate; combine 50-500 mL of an additive solution with the red blood cell concentrate to provide an intermediate red blood cell product intended for storage for 42 days or less, wherein the intermediate red blood cell product at the end of storage has an osmolarity value between 202-479 mOsm/L; and wash the intermediate red blood cell product comprising the osmolarity value between 202-479 mOsm/L with a washing solution having an osmolarity value higher than that of the intermediate red blood cell product comprising the osmolarity value between 202-479 mOsm/L. 1. A system for washing red blood cells , comprising:a separator configured to separate a quantity of blood into concentrated red blood cells having a hematocrit of at least 60% and a volume of 150-250 mL, and a supernatant component; remove the supernatant component to provide an initial red blood cell concentrate;', 'combine 50-500 mL of an additive solution with the red blood cell concentrate to provide an intermediate red blood cell product that is intended for storage for a period of time of 42 days or less, wherein the intermediate red blood cell product at the end of storage has an osmolarity value between 202-479 mOsm/L; and', 'wash the intermediate red blood cell product comprising the osmolarity value between 202-479 mOsm/L with a washing solution having an osmolarity value higher than that of the intermediate red blood cell product comprising the osmolarity value between 202-479 mOsm/L., 'a flow controller in communication with the separator, wherein the flow controller is configured to2. The system of claim 1 , wherein the additive solution ...

METHODS FOR CELL WASHING WITH ON-LINE DILUTION OF CELL FEED

Systems and methods for the washing of biological fluid/biological cells are disclosed. The method provides for the automated dilution of the cell feed during the cell washing procedure using a separator in which the separator has a predetermined maximum output concentration for the biological cells that are being washed. The method further includes determining the concentration ratio of the biological cells to be washed in the washing procedure and determining a maximum input concentration as a function of the maximum output concentration and the concentration ratio. Wash solution is then added to dilute said biological cells so that the maximum input concentration of the diluted biological cells entering the separator is not exceeded. 1. A method for washing biological cells with a separator comprising a relatively rotatable cylindrical housing and an internal member , wherein said cylindrical housing has an interior surface and said internal member has an exterior surface , said surfaces defining a gap therebetween , wherein at least one of said surfaces includes a porous membrane and for which a maximum output concentration that can be processed by the separator has been established , the method comprising:determining a concentration ratio of the biological cells to be washed in the washing procedure;determining a maximum input concentration as a function of the maximum output concentration and the concentration ratio;drawing biological cells from a container in flow communication with said separator;adding wash solution to dilute said biological cells so that the maximum input concentration is not exceeded;introducing said diluted cells into said gap of said separator;rotating at least one or both of said housing and said internal member;separating said cells from at least some of said wash solution;concentrating said cells;removing at least some of said concentrated cells from said separator through a first outlet; andremoving at least some of said separated ...

SYSTEM AND METHOD FOR SEPARATING CELLS INCORPORATING MAGNETIC SEPARATION

A cell processing system includes a first processor connectable to a source container filled with a biological fluid, a second processor, and a controller coupled to the processors. The first processor includes a separator configured to separate the biological fluid into at least two streams of material, and a first container configured to receive one of the streams. The second processor includes a magnetic separator configured to select target cells, the target cells being associated with magnetic particles, a second, pass-through container associated with the magnetic separator, the second container connected at a first end to the first container, and a third container connected to a second end of the pass-through container. One of the processors includes at least one pump configured to transfer material between the separator and the first container, and between the first container and the second container. 1. A cell processing system comprising: a separator configured to separate the biological fluid from the source container into at least two streams of material; and', 'a first container configured to receive one of the at least two streams along a first fluid pathway;, 'a first processor connectable to a source container filled with a biological fluid, the first processor comprising a magnetic separator configured to select target cells, the target cells being associated with magnetic particles;', 'a second, pass-through container associated with the magnetic separator, the second container connected at a first end to the first container along a second fluid pathway; and', 'a third container connected to a second end of the pass-through container; and, 'a second processor connectable to the first container, the second processor comprisingone of the first processor and the second processor comprising at least one pump configured to transfer material between the separator and the first container along the first fluid pathway, and between the first container and ...

System and Method for Determining Irradiation Exposure Time with Irradiation Sensors During Extracorporeal Photopheresis

An irradiation device for photopheresis, comprising an exposure chamber configured to receive an illumination container holding a target cell suspension; an irradiation source configured to irradiate the illumination container and target cell suspension for a certain exposure time period; an irradiation sensor configured to detect the intensity of irradiation emitted by the irradiation source; and a processing circuit coupled to the irradiation sensor and configured to treat the target cell suspension with a predetermined treatment dosage of radiation, wherein the processing circuit adjusts the exposure time period based on the intensity of irradiation in order to achieve the predetermined treatment dosage. 1. An irradiation device for photopheresis , comprising:an exposure chamber configured to receive an illumination container holding a target cell suspension;an irradiation source configured to irradiate the illumination container and target cell suspension for a certain exposure time period;an irradiation sensor configured to detect the intensity of irradiation emitted by the irradiation source; anda processing circuit coupled to the irradiation sensor and configured to treat the target cell suspension with a predetermined treatment dosage of radiation, wherein the processing circuit adjusts the exposure time period based on the intensity of irradiation in order to achieve the predetermined treatment dosage.2. The irradiation device of claim 1 , wherein the target cells comprise mononuclear cells.3. The irradiation device of claim 1 , wherein the target cell suspension contains photoactivation agent 8-methoxypsoralen.4. The irradiation device of claim 1 , wherein the irradiation source emits UV-A light and the irradiation sensor senses UV-A light.5. The irradiation device of claim 1 , wherein the irradiation source comprises at least one of a light bulb and LED lighting.6. The irradiation device of claim 1 , wherein the irradiation sensor is disposed within the ...

SYSTEM AND METHOD FOR DETECTING MINIMUM HEMATOCRIT WITH IRRADIATION RECEIVERS DURING EXTRACORPOREAL PHOTOPHERESIS

An irradiation device for photopheresis, comprising an exposure chamber configured to receive an illumination container holding a target cell suspension, an irradiation transmitter configured to irradiate the illumination container and target cell suspension, an irradiation receiver configured to detect absorption of radiation from the irradiation transmitter, and a processing circuit coupled to the irradiation receiver and configured to determine whether a hematocrit of the target cell suspension exceeds a predetermined threshold hematocrit and to treat the target cell suspension with a treatment dosage of radiation if the predetermined threshold is exceeded. 1. An irradiation device for photopheresis , comprising:an exposure chamber configured to receive an Hum nation container holding a target cell suspension;an irradiation transmitter configured to irradiate the illumination container and target cell suspension;an irradiation receiver configured to detect radiation from the irradiation transmitter; anda processing circuit coupled to the irradiation receiver and configured to detect radiation absorption and to determine whether a hematocrit of the target cell suspension exceeds a predetermined threshold hematocrit and to treat the target cell suspension with a treatment dosage of radiation if the predetermined threshold is exceeded.2. The irradiation device of claim 1 , wherein the irradiation device is configured to elicit a response action if the hematocrit of the target cell suspension does not exceed the predetermined threshold hematocrit claim 1 , the response action comprising at least one of terminating the photopheresis procedure claim 1 , generating an error notification; and processing additional cell suspensions to increase hematocrit.3. The irradiation device of claim 1 , wherein the processing circuit is configured to use the irradiation transmitter and irradiation receiver to detect the hematocrit of the target cell suspension and to control the ...

SYSTEM AND METHOD OF COLLECTING AND INFUSING AN APOPTOTIC WHITE BLOOD CELL COMPONENT AND A TRANSPLANT COMPONENT

A method for prophylaxis or treatment of a graft's rejection of a recipient, driven and adjusted by a microprocessor-based controller. Provided is a fluid circuit comprising a first container configured to receive a transplant component and a second container configured to receive an apoptotic component. Provided is a separator configured to associate with the fluid circuit and separate whole blood into a red blood cell component, a plasma component, and a white blood cell component. Whole blood is directed into the fluid circuit and the separator. The whole blood is separated into the red blood cell component, the plasma component, and the white blood cell component. A first portion comprising the transplant component of the white blood cell component is directed to the first container. A second portion of the white blood cell component is directed to the second container and the second portion is rendered apoptotic. 1. A method for prophylaxis or treatment of a graft's rejection of a recipient , at least partially driven and adjusted by a microprocessor-based controller , comprising the steps of:providing a disposable fluid circuit comprising a first product container configured to receive a transplant component and a second product container configured to receive an apoptotic component;providing a separator configured to associate with the disposable fluid circuit, the separator comprising a chamber configured to rotate about a rotational axis and convey whole blood into an inlet region of the chamber for separation into a red blood cell component, a plasma component, and a white blood cell component;directing whole blood from a blood source into the disposable fluid circuit and the separator;separating the whole blood into the red blood cell component, the plasma component, and the white blood cell component;directing a first portion comprising the transplant component of the white blood cell component to the first product container; anddirecting a second ...

SYSTEM AND METHOD OF STERILELY CONNECTING FLUID PATHWAYS

A sterile tube connector for a fluid circuit system comprising a housing. A first opening is configured to receive a first length of tubing in communication with a first chamber. A second opening is configured for communicating with the first chamber when the tube connector is in an open configuration but not in a closed configuration. The second opening is configured to reversibly engage a third opening to form a second chamber. The third opening is configured for communicating with a second length of tubing. A first portion of the housing forming the first opening comprises a material at least partially permeable to a sterilization energy source for sterilizing contents of the second chamber. 1. A tube connector for a fluid circuit system comprising: a first opening configured to receive a first length of tubing in communication with a first chamber;', 'a second opening configured for communicating with the first chamber when the tube connector is in an open configuration but not in a closed configuration;', 'a third opening configured to receive a second length of tubing in communication with a second chamber;', 'a fourth opening configured for communicating with the second chamber when the tube connector is in the open configuration but not in the closed configuration;, 'a housing comprisingwherein the second opening and the fourth opening are configured to engage each other to form a third chamber.2. The tube connector of claim 1 , wherein the housing comprises:a first sub-housing comprising the first opening, the second opening, and the first chamber; anda second sub-housing comprising the third opening, the fourth opening, and the second chamber;wherein at least a portion of the first and/or second sub-housings comprises a material comprising at least one of cyclic olefin copolymer (COC), poly(methyl methacrylate), polymethylpentene, and quartz glass.3. The tube connector of claim 2 , wherein the first and second sub-housings each comprises a connector ...

Systems and Methods for Treating a Biological Fluid with Light in the Event of a Bulb Outage

Methods and systems for treating a biological fluid with light are disclosed. The methods and systems include determining the light dose being delivered to a biological fluid and adjusting the duration of a treatment or the intensity of light emitted in the event of a detected light source outage. 1. A method for treating a biological fluid with light comprising:a) treating a biological fluid in an irradiation chamber of an irradiation device, said device comprising at least one array of multiple light sources;b) determining an effective light dose for the treatment of said biological fluid based on the intensity of light delivered to said biological fluid, wherein said effective light dose is based on the biological fluid to be treated, the intensity of the light delivered by the array of multiple light sources and the duration of the treatment;c) sensing the light dose delivered by said at least one array;d) adjusting the power delivered to said array and/or the duration of the light treatment in response to said sensing.2. The method of comprising detecting the light intensity of each one of said multiple light sources of said array.3. The method of comprising sensing the contribution of each one of said multiple light sources of said array to the sensed light dose delivered to said biological fluid.4. The method of comprising identifying an underperforming light bulb within said array.5. The method of comprising determining the actual light dose delivered to said biological fluid wherein at least one of said light bulbs is underperforming.6. The method of comprising adjusting the duration of said light treatment to arrive at said effective light dose.7. The method of wherein said adjusting said duration of said treatment is based at least in part on a location of said underperforming bulb within said array.8. The method of wherein said adjusting said duration of said treatment is based at least in part on said location of said underperforming bulb within said ...

Fluid Processing Cassettes Incorporating Micro- And Macrofluidic Channels

A fluid processing cassette includes first and second covers, with an interior wall positioned between the covers. The interior wall includes a first surface facing the first cover and defining a portion of a plurality of macrofluidic channels. A second surface of the interior wall faces the second cover and defines a portion of a plurality of microfluidic channels. At least one opening defined in the interior wall provides fluid communication between at least one of the macrofluidic channels and at least one of the microfluidic channels. An additional interior wall may also be positioned between the covers, with each interior wall secured to a different one of the covers and to the other interior wall. The additional interior wall may be positioned between the first cover and the interior wall, with macrofluidic channels defined on each side of the additional interior wall. 1. A fluid processing cassette comprising:first and second covers; andan interior wall positioned between the first and second covers, wherein a first surface facing the first cover and defining a portion of a plurality of macrofluidic channels, and', 'a second surface facing the second cover and defining a portion of a plurality of microfluidic channels, and', 'the interior wall defines at least one opening providing fluid communication between at least one of the plurality of microfluidic channels and at least one of the macrofluidic channels., 'the interior wall includes'}2. The fluid processing cassette of claim 1 , wherein the first cover is generally flexible.3. The fluid processing cassette of claim 1 , wherein the first cover is generally rigid.4. The fluid processing cassette of claim 1 , wherein at least one of the macrofluidic channels comprises a sensing station.5. The fluid processing cassette of claim 1 , wherein at least one of the macrofluidic channels comprises a valve station.6. The fluid processing cassette of claim 1 , wherein at least one of the macrofluidic channels ...

METHODS AND SYSTEMS FOR MATING DISPOSABLE SYRINGES WITH PNEUMATIC DRIVERS WITHOUT BREAKING STERILITY

A pneumatic driver for a syringe is provided. The syringe has an elongated barrel with a cap secured to the proximal end that has a through bore. A filter is secured to the cap interior of the barrel that covers an opening in the through bore interior of the barrel. The pneumatic driver includes a source of pressurized air; a support for receiving and locating the syringe; and a supply block configured to receive pressurized air from the source and having an outlet for delivery of pressurized air. The supply block is movable between a first position spaced apart from the cap of the syringe and a second position in contact with the cap with fluid communication being established between the outlet of the supply block and the through-bore in the cap. 1. An actuator for a syringe , the syringe comprising an elongated barrel having a first end , and a cap secured to the first end having a through-bore , the actuator comprising:a) a source of pressurized air;b) a support for receiving and locating the syringe; andc) a supply block configured to receive pressurized air from the source and having an outlet for delivery of pressurized air, the supply block being movable between a first position spaced apart from the cap of the syringe and a second position in contact with the cap with fluid communication being established between the outlet of the supply block and the through-bore in the cap.2. The actuator of further comprising a seal associated with one of the outlet of the supply block and the through-bore in the cap to provide a seal between the outlet of the supply block and the through-bore in the cap when the supply block is in the second position.3. The actuator of further comprising a base claim 1 , the source of pressurized air claim 1 , the support for receiving the syringe claim 1 , and the supply block being mounted to the base.4. The actuator of further comprising the source of pressurized air and the support for receiving the syringe being affixed to the base ...

METHODS AND SYSTEMS FOR CONTROLLING THE FLOW RATE IN A PNEUMATIC SYRINGE

A method for controlling the flow rate of a pneumatic syringe in a system that includes a disposable fluid circuit and reusable hardware configured to accept the disposable fluid circuit. The disposable fluid circuit includes one or more syringes, while the reusable hardware includes a syringe pump for each syringe of the disposable fluid circuit and a controller. The syringe pump includes a vacuum/pressure source for moving the piston within the syringe and a position detector for indicating the position of the piston within the syringe. The method controls several distinct phases of the process: break pressure targeting, glide control and vent control, and the method is the same regardless of whether a positive pressure or a vacuum is applied to the piston of the syringe. Preferably, a proportional-integral-derivative (“PID”) feedback loop is used for controlling the movement of the piston in the syringe. 1. A method for controlling movement of a piston having a first and second side in a syringe with a system comprising a pump for introducing pressurized air/vacuum into the syringe to act on the first side of the piston , the method comprising:a) operating the pump at a first speed introduce pressurized air/vacuum into the syringe to act on the first side of the piston;b) decreasing the speed of the pump linearly to -0- until a nominal break pressure is achieved;c) increasing the pump speed until movement of the piston is detected;{'sub': 'target', 'd) determining a target volume Vfor the syringe for each increment of time after movement of the piston has been detected based on a target flow rate;'}{'sub': 'current', 'e) measuring a current volume Vof the syringe at each time increment;'}{'sub': error', 'error', 'target', 'current, 'f) determining a volumetric error Vat each increment of time, such that V=V−V;'}{'sub': 'error', 'g) determining a controller output based on Vusing Proportional-Integral-Derivative control logic;'}h) adjusting the pump speed ...

Cell Processing System And Method With Preliminary Process Evaluation

A cell processing system includes a processor connectable to a source container filled with a biological fluid, the processor including a separator configured to separate the biological fluid from the source container into at least two streams according to a process including at least one process parameter, and a controller coupled to the processor and an input. The controller is configured to receive the at least one process parameter, to evaluate the process using the at least one process parameter before performing the process, and to carry out one or more actions based on the evaluation, such as providing an output estimate to the operator, preventing the process from being performed according to a comparison between a calculated condition and a control, or providing an error indication to the operator according to the calculated condition and a measured in-process condition. 1. A blood processing system comprising:a blood processing apparatus comprising reusable hardware and a disposable fluid circuit, the blood processing apparatus comprising a separator configured to perform a centrifugal separation process on a biological fluid from a source to provide a blood component in a product container, the reusable hardware comprising a weight scale configured to weigh the product container and an air detector sensor;a touch screen configured to receive input from an operator;a transmitter/receiver device configured to communicate over a network and to receive process parameters from a server computer; and receive an activation from the operator to switch on the blood processing system;', 'conduct self-checks on the blood processing apparatus;', 'receive input data for a value of a process parameter from the touch screen;', 'verify that the value is within a preset range for the value;', 'prior to operating the blood processing apparatus according to a centrifugal separation process, store a pre-process calculation of a volume of the blood component to be collected ...

Cell processing method

A method of processing blood includes receiving from a touch screen user input data for a protocol for a wash procedure. The user input data includes a numeric value. The method includes storing the protocol in a memory, receiving an identifier from a user, determining if the identifier permits the user to modify the protocol and receiving a modification of the protocol from the user. The method includes providing a plurality of authorizations, a second authorization being a default and an administrator authorization permitting the user to change a setting. The method includes comparing a password to a password stored in memory and, if there is a match, determining that the password is associated with an administrator. If a command to change the setting is received, the command is applied to change the setting. The blood is processed employing a wash procedure using the modified protocol and the changed setting.

MEMBRANE SEPARATION DEVICES, SYSTEMS AND METHODS EMPLOYING SAME, AND DATA MANAGEMENT SYSTEMS AND METHODS

A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed. 112-. (canceled)14. The method of further comprising:flowing substantially concentrated red blood cells from the second container through a leukocyte filter and into a third container.15. The method of further comprising employing a needle for blood withdrawal from a donor claim 14 , the needle being of about 18-21 gauge.1624-. (canceled)25. The method of further comprising creating separate fluid flow regions within the gap during the separation of the whole blood into substantially concentrated red blood cells and plasma without the use of seals.26. The method of further comprising creating the separate fluid flow regions by providing one of the outer housing or inner rotor with a raised circumferential ridge that extends into the gap.27. The method of further comprising providing the ridge with a larger radial dimension to decrease mixing of fluids between the separate fluid flow regions.28. The method of further comprising providing the ridge with a larger axial dimension to decrease mixing of fluids between the separate fluid flow regions. This application claims the ...

System and method for processing, incubating, and/or selecting biological cells

A method for automated processing of a cellular product comprising target substrate cells, the method comprising providing a separation apparatus configured to associate with a disposable sterile circuit comprising a separator in communication with the cellular product. The apparatus and disposable sterile circuit are configured to remove platelets from the cellular product to form a platelet-depleted cellular product, resuspend the platelet-depleted cellular product in media to form a resuspended platelet-depleted cellular product, receive an agent having an association with the target substrate cells of the resuspended platelet-depleted cellular product, incubate the agent with the target substrate cells over a period sufficient for the agent to bind with and/or enter the target substrate cells to form a first mixture comprising agent-target substrate cell complexes, unbound/unassociated agent, and non-target substrate cells, and remove unbound/unassociated agent to form a second mixture comprising the agent-target substrate cell complexes and non-target substrate cells.

SYSTEM AND METHOD FOR SELECTING AND CULTURING CELLS

A cell processing system includes at least one processor connectable to a source container filled with a biological fluid, the at least one processor including a spinning membrane configured to receive and separate target cells from the biological fluid, the target cells exiting at a first outlet, one or more containers selectively connected to the first outlet; and, and a magnet. The system also includes a controller coupled to the at least one processor and configured to operate the spinning membrane to receive biological fluid from the source container and to direct the target cells to one of the one or more containers, to pause to permit magnetic particles to be associated with the target cells, and to operate the spinning membrane to receive the contents of one of the one or more containers with the magnet applied to the target cells associated with the magnetic particles. 1. A cell processing system comprising: a spinning membrane configured to receive and separate target cells from the biological fluid, the target cells exiting at a first outlet;', 'one or more containers selectively connected to the first outlet; and', 'a magnet;, 'at least one processor connectable to a source container filled with a biological fluid, the at least one processor comprising to operate the spinning membrane to receive biological fluid from the source container and to direct the target cells to one of the one or more containers,', 'to pause to permit magnetic particles to be associated with the target cells,', 'to operate the spinning membrane to receive the contents of one of he one or more containers with the magnet applied to the target cells associated with the magnetic particles., 'a controller coupled to the at least one processor and configured2. The cell processing system according to claim 1 , wherein the controller is configured to pause to permit a conjugated antibody bead to be added to the one or more containers and to permit the conjugated antibody bead to form ...

Automated Systems and Methods for Cell Culturing

Systems and methods for automated cell culturing are disclosed. The system includes a stand-alone device including a culturing vessel and an integrated controller for delivering fluids at pre-determined times and sensors for monitoring the conditions of the culturing environment. The sensors for monitoring the conditions are coupled to the controller. 1. A system for the culturing of biological cells comprising:(a) a culturing vessel comprising a top cap and a bottom support member defining a culturing chamber, said bottom support member carrying a gas permeable membrane;(b) a base assembly configured to receive said bottom support member in a gas-tight, mating manner, said base assembly further comprising one or more channels for delivering to and/or removing from said base one or more gases;(c) a culture medium source; and(d) a control system comprising one or more sensors for sensing at least one of temperature or pressure during cell culturing.2. The system of further comprising one or more tubes joined to said cap and extending into said culturing chamber claim 1 , said one or more tubes defining a flowpath for said culture medium.3. The system of wherein said base assembly further comprises an agitator.4. The system of wherein said agitator comprises a platform for tilting said vessel.5. The system of wherein said control system comprises a pressure sensor for monitoring gas pressure at the interface of said gas permeable membrane and said base assembly.6. The system of wherein said base assembly further comprises a heating element.7. The system of wherein said system further comprises a temperature sensor for measuring the temperature in said system.8. The system of wherein said temperature sensor is located in said base member.9. The system of wherein said controller is configured to adjust the temperature in said system in response to a reading from said temperature sensor.10. The system of further comprising a sensor for measuring the content of one of or ...

CELL PROCESSING SYSTEM AND METHOD WITH PRELIMINARY PROCESS EVALUATION

A cell processing system includes a processor connectable to a source container filled with a biological fluid, the processor including a separator configured to separate the biological fluid from the source container into at least two streams according to a process including at least one process parameter, and a controller coupled to the processor and an input. The controller is configured to receive the at least one process parameter, to evaluate the process using the at least one process parameter before performing the process, and to carry out one or more actions based on the evaluation, such as providing an output estimate to the operator, preventing the process from being performed according to a comparison between a calculated condition and a control, or providing an error indication to the operator according to the calculated condition and a measured in-process condition. 1. A cell processing system comprising:a processor connectable to a source container filled with a biological fluid, the processor including a separator configured to separate the biological fluid from the source container into at least two streams according to a process including at least one process parameter; and to receive the at least one process parameter via the input;', 'to calculate at least one output based on the at least one process parameter;', 'to provide the at least one calculated output to an operator prior to causing the processor to operate according to the process., 'a controller coupled to the processor and an input, the controller configured2. The cell processing system according to claim 1 , wherein the at least one calculated output comprises a time to complete the process claim 1 , or a part thereof claim 1 , a volume of wash media consumed claim 1 , a volume of waste fluid generated claim 1 , and a volume of a residual remaining in a product.3. The cell processing system according to claim 1 , wherein the controller is configured:to calculate the at least output ...

Fill and finish systems and methods for small volume processing

A system for processing fluids and filling a container with a product includes a disposable fluid circuit and reusable hardware configured to accept the disposable fluid circuit. The disposable fluid circuit includes a spinning membrane separator, first and second syringes, and a flow control cassette. The reusable hardware includes a drive coupled to the spinning membrane separator, first and second syringe pumps, the first and second syringes coupled to the first and second syringe pumps respectively, and a controller. The system also includes a syringe pump for filling low-volume containers, which syringe pump may be one of the first and second syringe pumps, or may be a third syringe pump. The syringe pump for filling low-volume containers may include a filtered vacuum/pressure source and a position detector.

SYSTEM AND METHOD FOR AUTHENTICATING DISPOSABLE COMPONENTS IN EXTRACORPOREAL PHOTOPHERESIS

A medical device verification system for an extracorporeal photopheresis procedure comprises a reusable irradiation device comprising a UV light source and a scanner. A fluid circuit comprises a disposable cell suspension container having a photo-reactive label comprising an identifiable code. The identifiable code is unobscured when the label in a first state and is obscured when the label is in a second state. The irradiation step is performed by irradiating the disposable cell suspension container for a predetermined period of time at or above the threshold UV irradiation level. A second input is received from the scanner during the irradiation step, the second input comprising identification of a state of the label. A response action is provided if the first input comprises identification of the second state of the label and/or if the second input comprises identification of the first state of the label. 1. A medical device verification system for an extracorporeal photopheresis procedure comprising:a reusable irradiation device comprising a UV light source and a scanner;a fluid circuit configured to cooperatively associate with the reusable irradiation device, the fluid circuit comprising a disposable cell suspension container having a photo-reactive label comprising an identifiable code, wherein the identifiable code is unobscured to the scanner when the label in a first state and is obscured to the scanner when the label is in a second state; and receive a first input from the scanner prior to an irradiation step, the first input comprising identification of a state of the label;', 'based on receiving the first input from the scanner identifying the first state of the label, performing the irradiation step by irradiating the disposable cell suspension container for a predetermined period of time at or above the threshold UV irradiation level;', 'receive a second input from the scanner during the irradiation step, the second input comprising identification of ...

Magnet-based systems and methods for transferring fluid

A system is provided for pumping fluid, with the system including a fluid pump and a cassette. The pump includes a motor and a piston that is movable toward and away from a flexible diaphragm of the cassette. A linkage connects the motor and the piston to move the piston toward and away from the diaphragm. At least a portion of the piston or the diaphragm is magnetized, with the other having at least a portion that is magnetized or formed of a ferromagnetic material, thereby magnetically coupling the piston and the diaphragm such that movement of the piston moves the diaphragm into and out of a cassette cavity aligned with the diaphragm and piston. Movement of the diaphragm into and out of the cavity changes the effective volume of the cavity, which has the effect of drawing fluid into or forcing fluid out of the cavity.

Fill and finish systems and methods

A variety of fill options is provided for a cell processing system. Certain options relate to a filling system associated with the cell processing system, the filling system comprising one or more filling stations, each with at least one container that may receive product from a container associated with a cell processing system. Other options relate to a syringe assembly that receives a product from a container associated with a cell processing system.

Methods and systems for controlling the flow rate in a pneumatic syringe

A method for controlling the flow rate of a pneumatic syringe in a system that includes a disposable fluid circuit and reusable hardware configured to accept the disposable fluid circuit. The disposable fluid circuit includes one or more syringes, while the reusable hardware includes a syringe pump for each syringe of the disposable fluid circuit and a controller. The syringe pump includes a vacuum/pressure source for moving the piston within the syringe and a position detector for indicating the position of the piston within the syringe. The method controls several distinct phases of the process: break pressure targeting, glide control and vent control, and the method is the same regardless of whether a positive pressure or a vacuum is applied to the piston of the syringe. Preferably, a proportional-integral-derivative ("PID") feedback loop is used for controlling the movement of the piston in the syringe.

membrane separation devices, systems and methods employing them and data management systems and methods

resumo patente de invenção: "dispositivos de separação de membrana, sistemas e métodos que empregam os mesmos e sistemas e métodos de gerenciamento de dados". a presente invenção refere-se a um dispositivo de separação de membrana que é revelado junto com sistemas e métodos que empregam o dispositivo nos procedimentos de processamento de sangue. em uma modalidade, um separador de membrana giratória é fornecido no qual pelo menos duas zonas ou regiões são criadas no vão entre a membrana e o invólucro de forma que a mistura do fluido entre as duas regiões seja inibida por uma nervura radial associada à membrana que diminui o vão entre a membrana e o invólucro para definir duas regiões de fluido, a crista isola o fluido nas duas regiões para minimizar a mistura entre os dois. sistemas e métodos automatizados são revelados para separar uma unidade de sangue total coletado previamente em componentes como células vermelhas concentradas e plasma para coletar células vermelhas e plasma diretamente de um doador em uma única etapa e para lavagem de células. sistemas e métodos de gerenciamento de dados e métodos de pré-ativação também são revelados. patent specification: "membrane separation devices, systems and methods employing same and data management systems and methods". The present invention relates to a membrane separation device which is disclosed in conjunction with systems and methods that employ the device in blood processing procedures. In one embodiment, a rotating membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the housing such that fluid mixing between the two regions is inhibited by a membrane-associated radial rib which decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolates fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole ...

Method for washing biological cells

A method for washing biological cells involves providing a separator which includes a relatively rotatable cylindrical housing and an internal member. The cylindrical. housing has an interior surface and an exterior surface. A gap is defined between the interior and exterior surfaces, and at least one of the surfaces includes a porous membrane. The method further includes the steps of introducing cells suspended in a liquid medium into the gap between the interior and exterior surfaces; rotating at least one or both of the housing and the internal member; separating the cells from the liquid medium; concentrating the cells; removing at least some of the concentrated cells from the separator through a first outlet to a first integrally connected in-process container; and removing at least some of the separated liquid medium from the separator through a second outlet.

System and method of washing red blood cells to reduce hemolysis

A method for washing red blood cells, comprising separating a quantity of blood into concentrated red blood cells having a hematocrit of at least 80% and a volume of 150-250mL, and a supernatant component; removing the supernatant component to provide an initial red blood cell concentrate; combining 50-500 mL of an additive solution with said red blood ceil concentrate to provide an intermediate red blood cell product; storing the intermediate red blood cell product for a period of time of 42 days or less, wherein the intermediate red blood cell product at the end of storage has an osmolarity value between 202-479 mOsm/L; and washing the intermediate red blood ceil product with a washing solution having an osmolarity value higher than that of the intermediate red blood cell product at the end of storage.

Cell washing system with process parameter control

A cell processing system includes a processor to receive a biological fluid to be processed, a controller coupled to the processor, the controller configured to operate the processor according to at least one modifiable process parameter, and at least one input coupled to the controller, the at least one input configured to receive an identifier and at least one process parameter control associated with the at least one process parameter that limits modification of the at least one process parameter if applied. The controller is configured to determine if the identifier is associated with an administrator authorization and to apply the at least one processor parameter control to the at least one process parameter if the identifier is associated with an administrator authorization.

METHOD FOR WASHING BIOLOGICAL CELLS

dispositivos de separação de membrana, sistemas e métodos que utilizam os mesmos, e sistemas e métodos de gerenciamento de dados. a presente invenção refere-se a um dispositivo de separação de membrana junto com sistemas e métodos que utilizam o dispositivo em procedimentos de processamento de sangue. em uma modalidade, proporciona-se um separador de membrana rotativo em que pelo menos duas zonas ou regiões são criadas no vão entre a membrana e o envoltório, de modo que a mistura do fluido entre as duas regiões seja inibida por uma nervura radial associada à membrana que diminui o vão entre a membrana e o envoltório que define as duas regiões de fluido, a crista que isola o fluido nas duas regiões para minimizar a mistura entre as duas. os sistemas e métodos automatizados são descritos para separar uma unidade de sangue total previamente coletado em componentes, tais como, glóbulos vermelhos e plasma concentrados, para coletar glóbulos vermelhos e plasma diretamente de um doador em uma única via, e para a lavagem de células. os sistemas e métodos de gerenciamento de dados e métodos de preparação também são descritos. membrane separation devices, systems and methods that use them, and data management systems and methods. the present invention relates to a membrane separation device together with systems and methods that use the device in blood processing procedures. in one embodiment, a rotary membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the envelope, so that the mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that reduces the gap between the membrane and the envelope that defines the two regions of fluid, the crest that isolates the fluid in the two regions to minimize mixing between the two. automated systems and methods are described for separating a unit of whole blood previously collected into components, such as concentrated red blood ...

System and method for creating sterile connections using ultraviolet light

A device for connecting first and second medical fluid flow systems includes a linear movement carriage system that is positioned within a housing. The carriage system includes first (18a) and second connector holders (18b) configured to hold first (22a) and second connectors (22b) of the first and second medical fluid flow systems, respectively. A coupler holder (28) is configured to hold a coupler (32) and is positioned substantially between the first and second connector holders. The first (18a) and second connector holders (18b) and the coupler holder (28) are relatively moveable between a separated configuration, where the first (22a) and second connectors (22b) and the coupler (32) are located in relatively spaced apart positions, and a joined configuration, where the first (22a) and second connectors (22b) engage the coupler (32). An ultraviolet light source (62) is positioned in the housing so as to irradiate the first (22a) and second connectors (22b) and the coupler (32). A drive system transitions the first (18a) and second connector holders (18b) and the coupler holder (28) between the separated and the joined configurations.

Low volume extracorporeal photopheresis systems and methods

Systems and methods for performing low volume (e.g., 500 mL or less) extracorporeal photopheresis (ECP) procedures are disclosed. Each of the different systems and methods eliminates the need for multiple kits and solutions and reduce some of the potential risks inherent in the use of such multiple kits and solutions.

Blood component pooling device, system and method

A device for pooling a blood component stored in source containers includes a pump or pumps configured to pump a fluid in a first direction and a second direction and receive a pump line having a first end connected to the source containers. A pool clamp is configured to receive a pool line having a first end connected to a second end of the pump line and a second end connected to a pool container. A wash clamp is configured to receive a wash line having a first end connected to the second end of the pump line and a second end connected to a wash media container. A controller is configured to open the pool clamp, close the wash clamp and operate the pump in the first direction and to alternatively close the pool clamp, open the wash clamp and operate the pump in the second direction.

Membrane separation devices, systems and methods employing same, and data management systems and methods

A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

Cell washing system and methods for washing small volumes of cells

A fluid circuit for cell washing is provided that comprises a spinning membrane separator and a fluid management system comprising a cassette that defines the fluid pathways, and including internally mechanical valving, pressure sensing and air sensing for controlling flow through the fluid pathways, thus minimizing the volume of the fluid circuit. Additionally, the fluid circuit comprises syringes that are acted on by syringe pumps associated with the hardware component of the system to provide pressure for moving fluid through the circuit. Preferably, the syringes are connected directly to the cassette, or formed integrally within the cassette housing, thus further minimizing the volume of the fluid circuit.

System and method for processing, incubating and/or selecting biological cells

A method for automated processing of a cellular product comprising target substrate cells, the method comprising providing a separation apparatus configured to associate with a disposable sterile circuit comprising a separator in communication with the cellular product. The apparatus and disposable sterile circuit are configured to remove platelets from the cellular product to form a platelet-depleted cellular product, resuspend the platelet-depleted cellular product in media to form a resuspended platelet-depleted cellular product, receive an agent having an association with the target substrate cells of the resuspended platelet-depleted cellular product, incubate the agent with the target substrate cells over a period sufficient for the agent to bind with and/or enter the target substrate cells to form a first mixture comprising agent-target substrate cell complexes, unbound/unassociated agent, and non-target substrate cells, and remove unbound/unassociated agent to form a second mixture comprising the agent-target substrate cell complexes and non-target substrate cells.

Membrane separation devices, systems and methods employing same, and data management systems and methods

A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

Syringe with syringe closure

A syringe including a barrel, a plunger, and a vented closure. The barrel has a bore, and an end with an opening in communication with the bore and a barrel flange disposed outwardly of the opening. The plunger is disposed in the bore, and is movable along the bore. The vented closure is attached to the barrel at the end, and includes a stopper, a cap and a filter. The stopper is disposed over and/or in the opening in communication with the bore. The cap includes a body disposed over the stopper, and a fastener engaged with the barrel flange. The filter is disposed between the stopper and the cap, or in at least one of the stopper and the cap.

Blood collection system with rotating surface and reusable hardware component

A system for automated blood collection and separation is provided. In an embodiment, the automated blood collection system may include a reusable hardware component, and a pre-assembled disposable fluid circuit component configured to interface with the hardware component. The disposable component may include a donor access device for withdrawing blood from a donor; a leukoreduction filter; a source of anticoagulant; a blood separation device which includes a rotating surface and a membrane substantially permeable to plasma and substantially impermeable to red blood cells to separate the blood into concentrated red cells and plasma. A first collection container is also included in the donor access device to receive concentrated red bloods cells from the blood separation chamber. A source of preservative solution is connected with the first collection container, and a second collection container is connected with the blood separation chamber for receipt of the plasma.

System and method for authenticating disposable components in extracorporeal photopheresis

A medical device verification system for an extracorporeal photopheresis procedure comprises a reusable irradiation device comprising a UV light source and a scanner. A fluid circuit comprises a disposable cell suspension container having a photo-reactive label comprising an identifiable code. The identifiable code is unobscured when the label in a first state and is obscured when the label is in a second state. The irradiation step is performed by irradiating the disposable cell suspension container for a predetermined period of time at or above the threshold UV irradiation level. A second input is received from the scanner during the irradiation step, the second input comprising identification of a state of the label. A response action is provided if the first input comprises identification of the second state of the label and/or if the second input comprises identification of the first state of the label.

Cell processing system and method with preliminary process evaluation

A cell processing system includes a processor connectable to a source container filled with a biological fluid, the processor including a separator configured to separate the biological fluid from the source container into at least two streams according to a process including at least one process parameter, and a controller coupled to the processor and an input. The controller is configured to receive the at least one process parameter, to evaluate the process using the at least one process parameter before performing the process, and to carry out one or more actions based on the evaluation, such as providing an output estimate to the operator, preventing the process from being performed according to a comparison between a calculated condition and a control, or providing an error indication to the operator according to the calculated condition and a measured in-process condition.

Device and method for processing and producing autologous platelet-rich plasma

A system and method are provided, including an integrated single-use kit, for processing whole blood to produce platelet rich plasma. A two stage spinning membrane separator, has a first stage for receiving whole blood and separating substantially all red blood cells from plasma and platelets, and a second stage for further separating platelet rich plasma from plasma. A first waste container is in fluid communication with the first stage of the separator for receiving separated red blood cells, while a second waste container is in fluid communication with the second stage of the separator for receiving separated plasma. An outlet line is in fluid communication with the second stage of the separator for receiving platelet rich plasma, and a reinfusion container is removably connected to the outlet line for receiving platelet rich plasma from the second stage of the separator.

Membrane separation devices, systems and methods employing same

System and method for selecting and culturing cells

A cell processing system includes at least one processor connectable to a source container filled with a biological fluid, the at least one processor including a spinning membrane configured to receive and separate target cells from the biological fluid, the target cells exiting at a first outlet, one or more containers selectively connected to the first outlet; and, and a magnet. The system also includes a controller coupled to the at least one processor and configured to operate the spinning membrane to receive biological fluid from the source container and to direct the target cells to one of the one or more containers, to pause to permit magnetic particles to be associated with the target cells, and to operate the spinning membrane to receive the contents of one of the one or more containers with the magnet applied to the target cells associated with the magnetic particles.

Method for priming a membrane separator

A fluid processing apparatus and method employing the apparatus is provided. The apparatus includes a separator having a housing with a top and a bottom, at least one port adjacent each of the top and the bottom of the housing, and a membrane configured to spin about a generally vertically-oriented axis. The method for priming the apparatus includes: introducing a priming solution through the port at the bottom of the housing; flowing additional priming solution through the port at the bottom of the housing so that a priming solution-air interface is formed that advances upwardly through the housing to displace air within the housing and to expel the air through the port at the top of the housing, and to simultaneously wet the membrane. Additional priming solution is continuously flowed through the port at the bottom of the housing until the fluid-air interface has advanced vertically across the entire membrane.

Magnetic selector and systems incorporating same

【課題】細胞を含む流体に磁場を印加するための装置、および磁場を印加するためのそのような装置を組み込んだシステムを提供する。【解決手段】磁気セレクタは容器を受け入れるように構成され、容器を配置する床を有するハウジングを含む。セレクタはまた、床の容器とは反対側に配置される磁石キャリアを含む。磁石キャリアはその上に配置される少なくとも１つの磁石を有し、磁石キャリアが床に隣接する第１の状態と磁石キャリアが床から離間する第２の状態との間で床に対して移動可能である。セレクタはドアを含んでもよい。磁気セレクタは、生物学的流体が充填された供給源容器に接続可能な流体処理部を含む流体処理システムにおいて利用可能である。容器は磁気セレクタ内に配置され、流体経路に沿って処理部に接続されている。処理部は供給源容器からの生物学的流体を少なくとも２つの材料の流れに分離するように構成されている。【選択図】図２

Membrane separation devices, systems and methods employing same, and data management systems and methods

A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

Systems And Methods For Separating Cells Incorporating A Magnetic Selector

A method of operating a magnetic selector is provided. The magnetic selector includes a housing including a floor having a floor surface, a magnet carrier disposed on an opposite side of the floor from the floor surface and having at least one magnet disposed thereon, the magnet carrier being moveable relative to the floor between a first state wherein the magnet carrier is adjacent the floor and a second state wherein the magnet carrier is spaced from the floor. The method includes disposing a container on the floor surface, moving the magnet carrier to the first state to apply a magnetic field to a fluid in the container, moving the magnet carrier to the second state from the first state to disengage the magnetic field from the container, and removing the container.

Systems and methods for single needle continuous blood processing

Certain examples describe systems and methods for processing blood. An example method includes receiving blood extracted from a blood source connected to a blood collection machine. The example method includes processing the blood using a filtration or separation device to remove at least a portion of a targeted component included in the blood to separate the targeted component removed from a non-targeted component. The non-targeted component may then be re-processed using either the same or a different filtration or separation device to remove an additional amount of the targeted component.

Method for priming a membrane separator

A membrane separation device is disclosed along with systems and methods employing the device in blood processing procedures. In one embodiment, a spinning membrane separator is provided in which at least two zones or regions are created in the gap between the membrane and the shell, such that mixing of the fluid between the two regions is inhibited by a radial rib associated with the membrane that decreases the gap between the membrane and the shell to define two fluid regions, the ridge isolating the fluid in the two regions to minimize mixing between the two. Automated systems and methods are disclosed for separating a unit of previously collected whole blood into components, such as concentrated red cells and plasma, for collecting red cells and plasma directly from a donor in a single pass, and for cell washing. Data management systems and methods and priming methods are also disclosed.

Methods and systems for controlling the flow rate in a pneumatic syringe

A method for controlling the flow rate of a pneumatic syringe in a system that includes a disposable fluid circuit and reusable hardware configured to accept the disposable fluid circuit. The disposable fluid circuit includes one or more syringes, while the reusable hardware includes a syringe pump for each syringe of the disposable fluid circuit and a controller. The syringe pump includes a vacuum/pressure source for moving the piston within the syringe and a position detector for indicating the position of the piston within the syringe. The method controls several distinct phases of the process: break pressure targeting, glide control and vent control, and the method is the same regardless of whether a positive pressure or a vacuum is applied to the piston of the syringe. Preferably, a proportional-integral-derivative (“PID”) feedback loop is used for controlling the movement of the piston in the syringe.

Blood collection system with rotating surface

A whole blood separation system and method of use is provided. The system includes a disposable fluid flow circuit and a durable controller to control flow through the fluid circuit. The disposable fluid circuit includes a whole blood fluid flow path with a whole blood inlet; a cell preservation solution flow path; and a separator including an inner rotor mounted within a housing. A gap is defined between an outer surface of the rotor and an inner surface of the housing, and the outer surface of the rotor or inner surface of the housing includes a filter membrane configured to allow the passage of plasma while blocking red cells. The outer housing includes an inlets and outlets in fluid communication with the whole blood and/or cell preservation solution flow paths, and is in flow communication with the gap for directing whole blood and/or cell preservation solution into the gap.

System for washing red blood cells to reduce hemolysis

Systems and methods for concentrating cells with a syringe and a centrifuge

A system for concentrating cells, wherein a syringe comprises a lumen and an axial end comprising a port and a radial end closed to liquid flow. A plunger divides the axial and radial ends, and the syringe is configured to hold a cellular suspension. A filter disposed at the radial end is configured to maintain sterility of the syringe. A cap comprises a vent disposed at the radial end. The plunger is configured to be actuated towards the axial end by air pressure being applied into the radial end and the plunger is configured to be actuated towards the radial end by a vacuum being applied into the radial end.

Reversible sterile connection system

Systems, devices and methods for establishing a sterile fluid flow path between two or more fluid processing sets are disclosed. The systems, devices and methods include two or more connectors to which tubes of two or more fluid processing sets are attached. The connectors are brought together in an air-tight, non-permanent engagement with one another and treated with sterilizing light.

Spinning membrane separator priming systems and methods

A priming subsystem of a cell processing system carries out a method for priming a spinning membrane separator having an inlet and first and second outlets. The method includes opening a first selectable junction disposed between a priming fluid container and the inlet to open a path between the priming fluid container and the inlet, operating a first pump coupled to the first outlet to draw priming fluid from the priming fluid container into the spinning membrane separator, and closing the first selectable junction and a second selectable junction coupled to the second outlet after drawing the priming fluid into the spinning membrane separator. The method further includes operating the first pump after the first selectable junction is closed to draw a vacuum, and opening the first selectable junction after drawing the vacuum.

Methods and systems for mating disposable syringes with pneumatic drivers without breaking sterility

A pneumatic driver for a syringe is provided. The syringe has an elongated barrel with a cap secured to the proximal end that has a through bore. A filter is secured to the cap interior of the barrel that covers an opening in the through bore interior of the barrel. The pneumatic driver includes a source of pressurized air; a support for receiving and locating the syringe; and a supply block configured to receive pressurized air from the source and having an outlet for delivery of pressurized air. The supply block is movable between a first position spaced apart from the cap of the syringe and a second position in contact with the cap with fluid communication being established between the outlet of the supply block and the through-bore in the cap.

System and method for selecting and culturing cells

A cell processing system includes at least one processor connectable to a source container filled with a biological fluid, the processor including a spinning membrane configured to receive and separate target cells from the biological fluid, the target cells exiting at a first outlet, first and second containers selectively connected to the first outlet; and a magnet. The system also includes a controller configured to operate the spinning membrane to receive biological fluid and to direct the target cells to the first container, to pause to permit magnetic particles to be associated with the target cells in the first container, to operate the spinning membrane to receive the contents of the first container with the magnet applied to the target cells associated with the magnetic particles, to remove or deactivate the magnet, and to transfer the target cells to the second container.

Cell processing methods with process parameter control

A method of processing blood includes receiving from a touch screen user input data for a protocol for a wash procedure. The user input data includes a numeric value. The method includes storing the protocol in a memory, receiving an identifier from a user, determining if the identifier permits the user to modify the protocol and receiving a modification of the protocol from the user. The method includes providing a plurality of authorizations, a second authorization being a default and an administrator authorization permitting the user to change a setting. The method includes comparing a password to a password stored in memory and, if there is a match, determining that the password is associated with an administrator. If a command to change the setting is received, the command is applied to change the setting. The blood is processed employing a wash procedure using the modified protocol and the changed setting.

Hand-held sterile connection device, system, and method of use

A device, system, and method for sterilizing a fluid pathway connection are disclosed. The device, system, and method utilize a hand-held sterilization device. The device may create temporary sterile flow paths.

Systems and methods for automated recovery of white blood cells after producing a leuko-reduced blood product

Systems and methods for automated recovery of white blood cells after producing a leuko-reduced blood product

Blood component pooling device, system and method

Fill and finish systems and methods

A variety of fill options is provided for a cell processing system. Certain options relate to a filling system associated with the cell processing system, the filling system comprising one or more filling stations, each with at least one container that may receive product from a container associated with a cell processing system. Other options relate to a syringe assembly that receives a product from a container associated with a cell processing system.

Systems for processing a small volume of blood-cells

A fluid processing system includes a disposable fluid circuit and reusable hardware configured to accept the disposable fluid circuit. The disposable fluid circuit includes a spinning membrane separator, first and second syringes, and a flow control cassette. The reusable hardware includes a spinning membrane separator drive coupled to the spinning membrane separator, first and second syringe pumps coupled to the first and second syringes respectively, a control cassette interface coupled to the flow control cassette, and at least one controller coupled to the spinning membrane separator drive, the first and second syringe pumps, and the control cassette interface. The controller is configured to selectively operate the drive, the first and second syringe pumps, and the interface to provide a procedure according to a protocol.

Method and systems for mating disposable syringes with pneumatic drivers without breaking sterility

A pneumatic driver for a syringe is provided. The syringe has an elongated barrel with a cap secured to the proximal end that has a through bore. A filter is secured to the cap interior of the barrel that covers an opening in the through bore interior of the barrel. The pneumatic driver includes a source of pressurized air; a support for receiving and locating the syringe; and a supply block configured to receive pressurized air from the source and having an outlet for delivery of pressurized air. The supply block is movable between a first position spaced apart from the cap of the syringe and a second position in contact with the cap with fluid communication being established between the outlet of the supply block and the through-bore in the cap.

Systems and methods for automated recovery of white blood cells after producing a leuko-reduced blood product

The present disclosure relates to systems and methods for the separation of blood into blood products and, more particularly, to systems and methods that permit automated recovery of white blood cells after producing a leukocyte-reduced blood product.

Method and systems for mating disposable syringes with pneumatic drivers without breaking sterility

Reversible sterile connection system

Systems, devices and methods for establishing a sterile fluid flow path between two or more fluid processing sets are disclosed. The systems, devices and methods include two or more connectors to which tubes of two or more fluid processing sets are attached. The connectors are brought together in an air-tight, non-permanent engagement with one another and treated with sterilizing light.

Hand-held sterile connection device, system, and method of use

A device, system, and method for sterilizing a fluid pathway connection are disclosed. The device, system, and method utilize a hand-held sterilization device. The device may create temporary sterile flow paths.

Cell Processing System And Method With Preliminary Process Evaluation

A cell processing system includes a processor connectable to a source container filled with a biological fluid, the processor including a separator configured to separate the biological fluid from the source container into at least two streams according to a process including at least one process parameter, and a controller coupled to the processor and an input. The controller is configured to receive the at least one process parameter, to evaluate the process using the at least one process parameter before performing the process, and to carry out one or more actions based on the evaluation, such as providing an output estimate to the operator, preventing the process from being performed according to a comparison between a calculated condition and a control, or providing an error indication to the operator according to the calculated condition and a measured in-process condition.

Systems and methods for single needle continuous blood processing

Certain examples describe systems and methods for processing blood. An example method includes receiving blood extracted from a blood source connected to a blood collection machine. The example method includes processing the blood using a filtration or separation device to remove at least a portion of a targeted component included in the blood to separate the targeted component removed from a non-targeted component. The non-targeted component may then be re-processed using either the same or a different filtration or separation device to remove an additional amount of the targeted component.

Systems and methods for single needle continuous blood processing

Certain examples describe systems and methods for processing blood. An example method includes receiving blood extracted from a blood source connected to a blood collection machine. The example method includes processing the blood using a filtration or separation device to remove at least a portion of a targeted component included in the blood to separate the targeted component removed from a non-targeted component. The non-targeted component may then be re-processed using either the same or a different filtration or separation device to remove an additional amount of the targeted component.

Method and systems for mating disposable syringes with pneumatic drivers without breaking sterility

Hand-held sterile connection device, system, and method of use

A device, system, and method for sterilizing a fluid pathway connection are disclosed. The device, system, and method utilize a hand-held sterilization device. The device may create temporary sterile flow paths.