Fenwal, Inc.

Amit J Patel

Samantha M Planas

Kyungyoon Min

Daniel R Boggs

Walter T Watts

Melissa A Thill

Kathleen M Higginson

Brian C Case

Lan T Nguyen

Katherine N Radwanski

Courtney Moore

William Henry Cork, Iii

Christopher J Wegener

Fletcher C Belt

Nicholas Reimold

Elizabeth Asma

Jonathan Elicson

Andrew Vazquez

William Henry Cork Iii

William H Cork Iii

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 determines a total blood volume for a donor based on donor weight, height and gender. The system comprises a touchscreen for receiving a confirming user input and a scanning device configured to scan a bar code associated with a donor. The system and method operate a plurality of draw and return phases.

Plasma collection

A system with container volume tracking includes a pump receiving a line connected to a tracked container, an air sensor to detect air in the line, and a controller coupled to pump and sensor. The controller is configured to monitor pump operation, and determine a volume removed from the container based thereon. If the volume removed is less than a first percentage of a target volume and there is air, continue operation after an air purge. If the volume removed is more than the first percentage and less than a second percentage and if there is air, prompt the user for an input, and continue operation after an air purge if a first input is received or end operation if a second input is received. If the volume removed is more than the second percentage and if there is air, end operation.

System and method with container volume tracking

A peristaltic pump system includes tubing with first and second tube collars. The system also includes a rotary peristaltic pump with a tube channel having first and second ends, a first tube guide disposed at the first end and a second tube guide disposed at the second end. The first and second tube guides each include a passage with an inner diameter that is larger than the outer diameter of the tubing. The first tube guide has an unrestricted shoulder configured to abut the first tube collar in an installation state, and the second tube guide has an unrestricted shoulder configured to abut the second tube collar in the installation state. The first tube guide passage is disposed between its shoulder and the first end of the tube channel, while the second tube guide passage is disposed between its shoulder and the second end of the tube channel.

Pump system with tube guides

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 donors 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.

Systems and methods for plasma collection

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.

Systems and methods for optimization of plasma collection volumes

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.

Plasma collection with remote programming

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.

A method of collecting plasma includes receiving donor parameters at a controller of a plasma collection device electronically from a donor management system. The method includes storing 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 method includes setting the target volume for raw plasma and controlling the plasma collection device to operate draw and return phases to withdraw whole blood from a donor and separate the whole blood into the plasma product and a second blood component comprising red blood cells and to return the second blood component to the donor. The controller operates the draw and return phases until a volume of raw plasma in the collection container equals the target volume of raw plasma.

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 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.

A method is provided for calibrating a pump during a blood separation procedure that has at least a first and second state or phase where fluid is flowed to or from a reservoir by action of the pump. The state or phase of the procedure may be a priming state, a draw state, a separation state and a return state, and the pump calibration may be performed between consecutive performances of the same procedure state. The calibration is based on a variance between the volume of fluid predicted to be processed by the pump for the given state of the procedure and the actual volume processed based on the change of weight of the reservoir. Recalibration of the pump, if necessary, is accomplished before the performance of the second phase is commenced.

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Algonquin, IL, United States of America

Amit J Patel