A blood processing system includes a durable hardware component and a single-use fluid flow circuit. The hardware component includes a controller configured to execute a procedure in which red blood cells are separated from whole blood and collected. An additive solution may be initially provided in a red blood cell collection container of the fluid flow circuit, with the controller actuating a pump system of the hardware component to convey the additive solution from the red blood cell collection container into an additive solution container of the fluid flow circuit. After red blood cells have been separated from blood and conveyed into the red blood cell collection container (along with at least a portion of the additive solution from the additive solution container), the red blood cells and additive solution in the red blood cell collection container may be conveyed into a whole blood container for collection and storage.
A system and method for collecting plasma comprises a control circuit configured to control operation of the system, the control circuit configured to receive one or more donor parameters. The control circuit estimates a physiological fluid amount of the donor based at least in part on the one or more donor parameters and calculates a target amount of plasma product comprising raw plasma and anticoagulant by multiplying a prestored constant by the estimated physiological fluid amount. The control circuit controls the system to operate draw and return phases to process whole blood into plasma product until a measured amount of plasma product in the collection container meets the target amount of plasma product.
A plasmapheresis system and a method for operating a plasmapheresis system are provided by which a volume of plasma product (i.e., anticoagulated plasma) so that that the targeted volume of pure plasma in the plasma product is determined based on donor-specific characteristics. In particular, the targeted amount of pure plasma to be collected is based on the weight, or the weight and the height, of the donor. The targeted volume of pure plasma to be collected, TVP, may be a multiple of the donor's weight. Alternatively, TVP may be a multiple of the donor's total blood volume, TBV, with the TBV of the donor being determined based on the donor's weight and height. A target volume for the plasma product to be collected, TVPP, is established, and separation of whole blood into a plasma component and a second component continues until the volume of plasma product in a collection container equals TVPP.
Medical containers and disposable fluid circuits (kits) including such containers are disclosed. The containers and kit components are made of a plastic composition including polyvinyl chloride and one or more plasticizers such as a citrate ester and an epoxidized vegetable oil are disclosed. Containers made from such compositions are useful in the storage red blood cells. Red blood cell products wherein the red blood cells exhibit a reduced level of hemolysis are also disclosed.
B32B 27/08 - Layered products essentially comprising synthetic resin as the main or only constituent of a layer next to another layer of a specific substance of synthetic resin of a different kind
A system and method for collecting plasma includes drawing whole blood from a donor, combining anticoagulant with the whole blood from the donor, separating the whole blood into a plasma product and a second blood component and sending the plasma product to a collection container. A controller receives parameters over a network from a remote computer, receives a user input to confirm the a parameter and/or procedure, determines a target volume for plasma product and/or raw plasma based on the parameters and, in response to confirming the donor, controls the system to collect the plasma using draw and return phases.
A plasmapheresis system and a method for operating a plasmapheresis system are provided by which the volume/weight of anticoagulated plasma that is collected is optimized. In one example, a nomogram is provided that utilizes the donor's hematocrit to calculate the volume/weight of raw plasma within a plasma product having the maximum volume permitted by the FDA nomogram. In a plasmapheresis procedure having multiple collection phases followed by a reinfusion cycle in which concentrated red blood cells are returned to the donor, the volume of plasma product to be collected is calculated prior to the start of each collection cycle to account for the donor's increasing hematocrit, thus resulting in a greater total volume of plasma product to be collected during the plasmapheresis procedure.
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.
Filter assemblies are processing biological fluid, such as blood or a blood component containing leukocytes. The filter assemblies include a flexible housing with first and second walls. A filtration medium and a support member are at least partially positioned between the walls of the housing, with a seal joining the walls of the housing, the filtration medium, and the support member. The filter assemblies may further include a pre-filter and/or a post- filter positioned between the walls of the housing. If provided, the pre- and post-filter may be positioned on opposite walls of the filtration medium, with the post-filter being a mesh positioned between the filtration medium and one of the walls of the housing or within an opening defined by the support member. A seal of the filter assembly may pass through the filtration medium, with the filtration medium being substantially omitted in a section of the seal.
ABSTRACT Filter assemblies are processing biological fluid, such as blood or a blood component containing leukocytes. The filter assemblies include a flexible housing with first and second walls. A filtration medium and a support member are at least partially positioned between the walls of the housing, with a seal joining the walls of the housing, the filtration medium, and the support member. The filter assemblies may further include a pre-filter and/or a post-filter positioned between the walls of the housing. If provided, the pre- and post-filter may be positioned on opposite walls of the filtration medium, with the post-filter being a mesh positioned between the filtration medium and one of the walls of the housing or within an opening defined by the support member. A seal of the filter assembly may pass through the filtration medium, with the filtration medium being substantially omitted in a section of the seal. -29- Date Recue/Date Received 2020-10-07
Flexible housing filters for filtration of fluids and methods of making such filters are disclosed. The filters include a molded frame with no peripheral seal that houses a filter medium.
Filter assemblies are processing biological fluid, such as blood or a blood component containing leukocytes. The filter assemblies include a flexible housing with first and second walls. A filtration medium and a support member are at least partially positioned between the walls of the housing, with a seal joining the walls of the housing, the filtration medium, and the support member. The filter assemblies may further include a pre-filter and/or a post-filter positioned between the walls of the housing. If provided, the pre- and post-filter may be positioned on opposite walls of the filtration medium, with the post-filter being a mesh positioned between the filtration medium and one of the walls of the housing or within an opening defined by the support member. A seal of the filter assembly may pass through the filtration medium, with the filtration medium being substantially omitted in a section of the seal.
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.
A61M 1/34 - Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration, diafiltration
B01D 61/00 - Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltrationApparatus, accessories or auxiliary operations specially adapted therefor
B01D 63/16 - Rotary, reciprocated or vibrated modules
13.
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.
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.
A61M 1/34 - Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration, diafiltration
B01D 61/00 - Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltrationApparatus, accessories or auxiliary operations specially adapted therefor
15.
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.
A61J 1/05 - Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids
A61J 1/14 - Containers specially adapted for medical or pharmaceutical purposes DetailsAccessories therefor
A61M 1/34 - Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration, diafiltration
B01D 61/00 - Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltrationApparatus, accessories or auxiliary operations specially adapted therefor
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.
A61M 1/34 - Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration, diafiltration
B01D 61/00 - Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltrationApparatus, accessories or auxiliary operations specially adapted therefor
B01D 65/00 - Accessories or auxiliary operations, in general, for separation processes or apparatus using semi-permeable membranes
17.
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.
A61M 1/34 - Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration, diafiltration
B01D 61/00 - Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltrationApparatus, accessories or auxiliary operations specially adapted therefor
Methods and apparatus for collecting blood samples in vacuum sample tubes are disclosed. The samples, including the initial blood sample, are substantially free of excess air. Disclosed is also a biological fluid sampling system (18) comprising: a plastic container (42) including an interior chamber (54); a sample access site (68) external to and spaced from said container by y preselected distance; an internal flow path (43) communicating with said access site and extending substantially into said interior chamber, said internal flow path providing the only path for blood flow into and from said chamber.
A separation apparatus and method are employed using a spearation channel (210) for rotation abut an axis. Such channel includes radially spaced apart inner (206) and outer (208) side wall portions and an end wall portion (224). An inlet (226) conveys fluid into the channel. A barrier (232) is located in the channel intermediate of the inner and outer side wall portions. A first flow path communicates between upstream and downstream sides of the barrier. A collection region may be located downstream of the barrier for communication with teh first flow path. An outer side wall section of the channel may be positioned radially outward of an upstream section thereof. The barrier (232) may joing the outer side wall portion (208) along a substantial portion of an axial length of the channel. First and second exit flow paths may allow communication with the channel either upstream or downstream of the barrier or both.
A filtration medium (14) is sealed within a housing (52, 54). The filtration medium (14) is sized and configured to define multiple filtration regions (28, 30) within the housing (52, 54), through which independent, though concurrent, blood filtration can occur. Each filtration region (28, 30) is served by its own inlet path, which conveys blood into the filtration region (28, 30). The filtration medium (14) in each region (28, 30) passes the blood to remove at least one undesired component, such as leukocytes. After filtration, the multiple regions (28, 30) convey the blood into a single, centrally located manifold (36). A single outlet (18) communicates with the manifold (36).
Flow-through systems for processing biological fluid are disclosed. The flow- through systems include a removal device in the flow path for removing unwanted compounds and agents. The removal device includes a removal media contained within a housing made of two separate portions sealed together. The housing is maintained in a substantially vertical disposition, thereby ensuring substantially uniform and complete exposure of the fluid to the media.
A61M 1/34 - Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration, diafiltration
A61M 1/36 - Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation
B01D 15/08 - Selective adsorption, e.g. chromatography
B01D 27/02 - Cartridge filters of the throw-away type with cartridges made from a mass of loose material
B01D 29/05 - Filters with filtering elements stationary during filtration, e.g. pressure or suction filters, not covered by groups Filtering elements therefor with flat filtering elements supported
patents
