Soft cassette with integrated features
Inventors
LADTKOW, Tanner J. • Benz, Davis • Hillam, Mark E.
Assignees
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Publication Number
US-12521474-B2
Publication Date
2026-01-13
Expiration Date
Abstract
A soft cassette includes a body including a flexible material and first and second component. The body defines first and second lumens and first and second chambers. The first lumen extends between first and second ends. The first chamber is in the first lumen such that fluid passing through the first lumen passes through the first chamber. The second lumen is fluidly connected to the first lumen at a first junction between the first end and the first chamber and a second junction between the second end and the first chamber such that fluid passing through the second lumen bypasses the first chamber. The second chamber is in the second lumen. The first component is on a first side of the second chamber and includes a first ferromagnetic metal or magnet. The second component is on a second side of the second chamber and includes a second ferromagnetic metal magnet.
Core Innovation
A soft cassette is described that defines a first lumen, a first chamber disposed in the first lumen, and a second lumen fluidly connected to the first lumen at a first junction and a second junction such that fluid passing through the second lumen bypasses the first chamber. The soft cassette also defines a second chamber in the second lumen, with a body comprising a flexible material.
The soft cassette includes a first cover cooperating with the body to define a first pocket and a second cover cooperating with the body to define a second pocket. A first component on a first side of the second chamber is included in the first pocket and comprises a first ferromagnetic metal or a first magnet, and a second component on a second side of the second chamber is included in the second pocket and comprises a second ferromagnetic metal or a second magnet.
In a region between the first side of the second chamber and the second side of the second chamber, at least one of the first side of the second chamber and the second side of the second chamber is configured to move between a first state and a second state based on a pressure in the second chamber. In the first state, the second chamber defines a first pressure and a first dimension between the first component and the second component; in the second state, the second chamber defines a second pressure and a second dimension between the first component and the second component, with the second pressure larger than the first pressure and the second dimension larger than the first dimension.
The disclosed invention also describes an apheresis system workflow and supporting device features for donor-related operations, including scanned donor identification, a graphical user interface, audible confirmation, and a blood component collection set including a plasma collection bottle with machine-readable markings such as barcode, QR, or RFID. The system uses donor ID information to manage donation progress and to differentiate donation conditions for a donor.
Claims Coverage
The independent claims include four inventive features: bypass flow and opposing ferromagnetic/magnet components, a soft cassette assembly with base plate and pressure sensor, manufacturing from thermoplastic sides with perimeter sealing, and pressure-driven movement between two states.
Soft cassette with bypass flow and opposing ferromagnetic/magnet components
A soft cassette with a body defining a first lumen with a first chamber, a second lumen connected at first and second junctions such that fluid passing through the second lumen bypasses the first chamber, and a second chamber in the second lumen; first and second covers defining first and second pockets; a first ferromagnetic metal or first magnet on a first side of the second chamber in the first pocket; and a second ferromagnetic metal or second magnet on a second side of the second chamber in the second pocket.
Soft cassette assembly with base plate, door, magnets, and pressure sensor
A soft cassette assembly comprising a base plate with receiving regions, a door attached to the base plate, a first magnet coupled to the base plate and a second magnet coupled to the door, and a pressure sensor in contact with the first magnet or the second magnet; a soft cassette attached to the base plate including a first lumen with a first chamber and a second lumen with junctions such that fluid passing through the second lumen bypasses the first chamber and a second chamber in the second lumen; and a first ferromagnetic metal component coupled to the first magnet on a first side of the second chamber and a second ferromagnetic material component coupled to the second magnet on a second side of the second chamber.
Manufacturing a soft cassette from thermoplastic sides with perimeter sealing
A method of manufacturing a soft cassette by forming a first side of a soft cassette body from a first thermoplastic sheet portion; forming a second side of the soft cassette body from a second thermoplastic sheet portion; fixing the first side to the second side to at least partially define a first lumen, a first chamber in the first lumen, a second lumen with junctions to bypass the first chamber, and a second chamber in the second lumen; and creating the soft cassette by sealing a perimeter of the first side and the second side.
Soft cassette with pressure-driven movement between two states
A soft cassette with a body defining a first lumen with a first chamber, and a second lumen connected at junctions such that fluid passing through the second lumen bypasses the first chamber, and a second chamber in the second lumen; first and second components on opposite sides of the second chamber comprising a first ferromagnetic metal or first magnet and a second ferromagnetic metal or second magnet; an unobstructed region between the first side and the second side; at least one of the first side or the second side configured to move between a first state and a second state based on a pressure in the second chamber; defining a first pressure and a first dimension in the first state and a second pressure and a second dimension in the second state; and requiring the second pressure larger than the first pressure and the second dimension larger than the first dimension.
Across the independent claims, the coverage centers on a soft cassette that supports bypass flow from a second lumen to a second chamber while bypassing a first chamber, paired ferromagnetic/magnet components positioned on opposite sides of the second chamber, and pressure-driven movement between two states with increased pressure and increased spacing in the second state. The assembly claim adds a base plate/door magnet arrangement with a pressure sensor contacting one of the magnets, and the manufacturing claim covers forming thermoplastic first and second sides, fixing them to define the lumen/chamber structure with bypass junctions, and sealing the perimeter to create the cassette.
Stated Advantages
Provides user feedback during donor identification and donation progress using a GUI and audible output.
Supports differentiated donation flow or donation volume parameters based on donor ID information such as age, body mass, weight, height, and target plasma volume.
Enables field calibration with self-calibration routines for pump/compressor and test port and for weight sensor/load sensor calibration.
Implements a calibration lockout when calibration fails.
Provides centrifuge enable/disable control using a moving loop holder with extended and retracted states, and provides clearance for housing hinging during loading/unloading.
Includes overload protection for the bottle tray load cell assembly using magnetic coupling and cam-valley/cam-lobe engagement.
Supports modular serviceability via service sleds with interconnections and unique sled identification memory codes for subsystem replacement.
Supports firmware/software update lockout via a server-based update check and provides alarm event handling with user-facing indicators and instructions.
Documented Applications
Donation workflow in an apheresis system using scanned donor identification and a plasma collection bottle with machine-readable markings (barcode/QR/RFID).
Field calibration and service routines for an apheresis system, including self-calibration and lockout on calibration failure.
Centrifuge operation control and mechanical loading/unloading support using a moving loop holder between extended and retracted states.
Bottle tray load cell assembly operation with overload protection and calibration-weight receptacles for calibration support.
Modular serviceability and rapid subsystem replacement using modular serviceability sleds and interconnections with identification memory codes.
Server-based firmware/software update lockout and alarm event handling with device logs (D-logs) and user feedback outputs.
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