Patent classifications
A61M1/3616
SYSTEMS AND METHODS FOR OPTIMIZATION OF PLASMA COLLECTION VOLUMES
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.
SYSTEMS AND METHODS FOR OPTIMIZATION OF PLASMA COLLECTION VOLUMES
A system for collecting plasma comprises a separator to separate whole blood from a donor into a plasma product and red blood cells, an anticoagulant line to introduce anticoagulant to the whole blood, a touchscreen, and a controller. The controller is configured to receive donor parameters electronically from a donor management system. The controller is configured to use a target volume for plasma product and/or raw plasma which is based at least in part on donor height and weight used to calculate total donor blood volume, the target volume for plasma product and/or raw plasma based on the total donor blood volume. The controller is configured to control the system to operate at least three draw and return phases to withdraw whole blood from a donor and separate the whole blood into the plasma product and the red blood cells and to return the red blood cells to the donor.
SYRINGE-BASED MANUAL EXTRACORPOREAL BLOOD TREATMENT SYSTEMS AND METHODS EMPLOYING BATCH PROCESSING
The disclosure provides a manual blood or body fluid treatment system comprising first and second reservoirs for holding a batch of blood from a patient and a filter for performing an extracorporeal treatment on blood passing therethrough by removing waste molecules and/or fluid. The first reservoir is constructed to be displaced vertically relative to the second reservoir and vice versa, such that a height difference between the first and second reservoirs causes blood or body fluid to flow between the reservoirs due to gravity.
Systems for removing air from the fluid circuits of a plasma processing system
The present specification discloses plasma processing systems that include a number of different fluid flow circuits that are defined by sources of fluid, fluid lines, fluid flow paths, waste containers, a mixer, a separator, valves, and a pump. The systems also include a connector tube and a solvent extraction device, wherein the connector tube and solvent extraction device are configured to be alternatively inserted in a same position along a fluid flow line. In addition, the systems include a controller that is configured to execute a plurality of programmatic instructions to open and close each of a first fluid flow line valve, a second fluid flow line valve, a third fluid flow line valve, and a fourth fluid flow line valve in a predetermined sequence to either enable or prevent a flow of fluid through various fluid flow lines.
Systems and methods for optimization of plasma collection volumes
A system for collecting plasma comprises a separator to separate whole blood from a donor into a plasma product and a second blood component, an anticoagulant line to combine anticoagulant with the whole blood, a touchscreen, and a controller. The controller is configured to receive donor parameters electronically from a donor management system. The controller is configured to use a target volume for raw plasma which is based at least in part on donor height and weight used to calculate total donor blood volume, the target volume for raw plasma based on the total donor blood volume. The controller is configured to control the system to operate draw and return phases to withdraw whole blood from a donor and return the second blood component to the donor until a volume of raw plasma in the collection container equals the target volume of raw plasma.
Systems and methods for optimization of plasma collection volumes
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.
EXTRACORPOREAL BLOOD TREATMENT SYSTEMS AND METHODS EMPLOYING BATCH PROCESSING
Disclosed are methods and systems for a body-fluid (e.g., blood) treatment. The methods and systems include (a) conveying a volume of body-fluid (e.g., blood) via a first conduit from a vascular access of a patient to a blood chamber at a first flow rate, the first conduit having only a single lumen; (b) conveying the body-fluid (e.g., blood) from the blood chamber through a filtration device at a second flow rate to perform an extracorporeal treatment on the blood and returning the treated blood to the blood chamber; and (c) returning the body-fluid (e.g., blood) from the blood chamber to the vascular access of the patient at a third flow rate via the first conduit, wherein the second flow rate is decoupled from both the first and third flow rates.
Systems and methods for optimization of plasma collection volumes
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.
Acoustic separation for bioprocessing
A method for separating cells in a biofluid includes pretreating the biofluid by introducing an additive comprising a cell activator, flowing the pretreated biofluid through a microfluidic separation channel, and applying acoustic energy to the microfluidic separation channel to accumulate target cells in a primary stream and non-target cells in a secondary stream. A system for microfluidic cell separation capable of separating target cells from non-target cells in a biofluid includes at least one microfluidic separation channel, a source of biofluid, a source of additive comprising a cell activator, and at least one acoustic transducer coupled to the microfluidic separation channel.
APPARATUS AND METHOD FOR INACTIVATIVING VIRUSES AND PATHOGENS IN CONVALESCENT PLASMA UNITS FROM RECOVERED COVID-19 PATIENTS
The novel coronavirus COVID-19 has caused a worldwide pandemic of enormous proportions resulting in significant levels of morbidity and mortality, tremendous pressures on the healthcare system, personal freedoms and society, and an unprecedented impact on the economies of the United States and the world. There are still significant unknowns about this very contagious and deadly virus, and these unknowns are coupled with no natural immunity. A promising therapeutic strategy is the utilization/transfusion of convalescent plasma from recovered COVID-19 patients. There are, however, risks involved in such transfusions from residual virus and other adventitious viruses and bacteria. These risks can be minimized by the pathogen clearance of convalescent plasma units in a hospital setting. There is an immediate need for the rapid pathogen inactivation/clearance of convalescent plasma units from recovered COVID-19 patients.
The present invention is a physical pathogen reduction and inactivation apparatus and method for controlling or eliminating transfusion-transmittable infections in convalescent plasma from recovered COVID-19 donors. The invention inactivates both nonenveloped and enveloped viruses as well as pathogenic bacteria and parasites in units of human plasma, while retaining the potency of natural biologically-active proteinaceous products in the pathogen-reduced plasma. The invention uses critical, near-critical or supercritical fluids for viral and pathogen reduction of units of donor blood plasma in blood bags. The apparatus is in the form of a transportable mobile unit, where it can be used in hospitals, blood banks, and medical facilities.