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Publication Number
US-11529442-B2
Publication Date
2022-12-20
Expiration Date
Abstract
Disclosed is a multiple bag system for fractionating blood, the system including a fluid collecting bag including at least one outlet port; at least first and second sampling bags, each including at least one inlet port and at least one outlet port; and a unit for transferring fluid from the fluid collecting bag to the sampling bags; wherein the unit for transferring fluid includes an acoustic sorter. Also disclosed is a method for fractionating blood into blood products.
Core Innovation
The invention relates to a closed disposable sterile multiple blood bag system and a method for high throughput preparation of blood products for blood transfusion. The system includes a fluid collecting bag containing whole blood from an individual and multiple sampling bags configured to collect different blood components. Transfer between bags is performed by first and second means for transferring fluid that include channels receiving acoustic fields applied by an acoustic wave generator, without centrifugation.
In the first means for transferring fluid, an acoustic field is applied inside a channel to separate blood cells collected into a first sampling bag from blood plasma collected into a second sampling bag. The channel has a cross section defined by a width measured along a first transverse axis and a thickness measured along a second transverse axis perpendicular to the first transverse axis, with first and second outlets separated along the second transverse axis. Sterile and fluid connections are established between the fluid collecting bag and the inlets of the first means and between the outlets of the first means and the inlets of the sampling bags.
In the second means for transferring fluid, an acoustic field is applied inside a channel to transfer the content of the first sampling bag and a second buffer bag into sampling bags for collecting red blood cell concentrate and platelet concentrate. The multiple-bag architecture further uses buffer media through a second buffer bag connected to the second means for transferring fluid, enabling sequential acoustic separation steps within a closed disposable sterile system.
Claims Coverage
The claim coverage centers on a closed disposable sterile multiple blood bag system and sequential acoustic-field separation using channel-based fluid-transfer means with specific channel geometry and sterile bag connections. The inventive features include the blood bag architecture, acoustic separation of blood cells and plasma, buffered transfer to obtain red blood cell concentrate and platelet concentrate, and additional channel and acoustic limitations.
Closed disposable sterile multiple blood bag system for high throughput transfusion products
A closed disposable sterile multiple blood bag system comprising a fluid collecting bag with sterile outlets, first and second sampling bags, a second buffer bag with a buffer medium, third and fourth sampling bags, and sterile fluid connections linking the bags to first and second means for transferring fluid.
Sequential acoustic-field fluid transfer to collect plasma and blood cells
First and second means for transferring fluid each comprise a channel with defined width and thickness, inlet(s) and first and second outlets separated on the second transverse axis; applying an acoustic field inside the channel of the first means by an acoustic wave generator while transferring fluid to collect blood cells in a first sampling bag and blood plasma in a second sampling bag.
Acoustic-field fluid transfer with buffer to collect red blood cell concentrate and platelet concentrate
Applying an acoustic field inside the channel of the second means for transferring fluid by means of the acoustic wave generator, transferring content of the first sampling bag together with the second buffer bag in the second means, and collecting red blood cell concentrate in a third sampling bag and platelet concentrate in a fourth sampling bag.
Channel thickness tied to acoustic wavelength
Applying an acoustic field inside a channel includes transferring fluid generated by an acoustic wave generator, where the channel thickness is equal to λ/2 or a multiple of λ/2.
Channel width constrained for the fluid-transfer means
The method is implemented with a channel width greater than or equal to the stated minimum width for the channel geometry used in the acoustic separation.
Channel thickness constrained for high-throughput operation
The method uses a channel thickness greater than a stated minimum threshold for the channels of the fluid-transfer means.
Acoustic wave generator coupled to the channel wall with acoustic conductance limits
Applying an acoustic field inside a channel includes coupling the acoustic wave generator to a first wall of the channel, with the first wall having acoustic conductance in the stated range.
High-throughput preparation throughput range
The method defines throughput ranging from 0.5 mL/min to 100 mL/min for high throughput preparation of blood products.
The inventive core combines a closed disposable sterile multiple blood bag architecture with sequential acoustic-field separation in channel-based fluid-transfer means. The claim coverage further includes specific channel geometry, acoustic wave generator coupling, sterile fluid connections, buffered separation to obtain red blood cell concentrate and platelet concentrate, and throughput-related limitations.
Stated Advantages
High throughput preparation of blood products to be used for blood transfusion.
Preparation of blood components by collecting blood cells and blood plasma separately using acoustic field application inside channels.
Preparation of red blood cell concentrate and platelet concentrate by sequential acoustic-field processing with buffer medium.
Documented Applications
Preparing blood products for blood transfusion, including separating whole blood into blood plasma and blood cells, and further fractionating into red blood cell concentrate and platelet concentrate within a closed disposable sterile multiple blood bag system.
Fractionation into additional products including producing white blood cell concentrate using additional stages.
White blood cell removal using optional white blood cell removal filters.
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