Fluid control and bypass features for an apheresis system
Inventors
Holmes, Brian M. • Felt, Thomas J. • Polodna, Taylor
Assignees
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Publication Number
US-12433989-B2
Publication Date
2025-10-07
Expiration Date
Abstract
Described are embodiments that include methods and devices for separating components from multi-component fluids. Embodiments may involve use of separation vessels and movement of components into and out of separation vessels through ports. Embodiments may involve the separation of plasma from whole blood. Also described are embodiments that include methods and devices for positioning portions, e.g., loops, of disposables in medical devices. Embodiments may involve use of surfaces for automatically guiding loops to position them into a predetermined position.
Core Innovation
The invention relates to a soft cassette having a direct flow lumen fluidly connected to a first port and a second port. The direct flow lumen includes compliant regions, where a first valve is configured to pinch the direct flow lumen closed at a first compliant region and a second valve is configured to pinch the direct flow lumen closed at a second compliant region. A drip chamber is inter-disposed in the direct flow lumen such that fluid passing through the direct flow lumen passes through the drip chamber.
The soft cassette further includes a fluid flow bypass path that is both fluidly connected to the direct flow lumen adjacent the first port and between the first port and the drip chamber, and fluidly connected to the direct flow lumen adjacent the second port and between the second port and the drip chamber. This configuration provides that fluid flowing through the fluid flow bypass path bypasses the drip chamber.
In system context, the disclosed apheresis system maintains processing while separated components are pushed back to the donor without stopping centrifugation, such that plasma separation continues while non-desired components are returned. The cassette and system-level routing cooperate with valves and pumps to support draw/return behavior in an apheresis process logic.
Claims Coverage
The document’s independent claim is directed to a soft cassette structure that includes compliant regions with pinch valves, a drip chamber inter-disposed in a direct flow lumen, and a fluid flow bypass path that bypasses the drip chamber. The dependent claims refine this structure with bypass branch details, an added fluid pressure annulus, compliant-region placement relative to bypass connections, occlusion of a bypass branch using a draw fluid control valve, and retaining previously sent donor fluid in the drip chamber during subsequent draws.
Soft cassette with pinch-valved direct flow lumen and interposed drip chamber
A soft cassette comprising a first port and a second port, a direct flow lumen fluidly connected to the first port and the second port including a first compliant region with a first valve configured to pinch the direct flow lumen closed, and a second compliant region with a second valve configured to pinch the direct flow lumen closed, and a drip chamber inter-disposed in the direct flow lumen such that fluid passing through the direct flow lumen passes through the drip chamber.
Fluid-flow bypass path bypassing the drip chamber
A fluid flow bypass path both fluidly connected to the direct flow lumen adjacent the first port and between the first port and the drip chamber and fluidly connected to the direct flow lumen adjacent the second port and between the second port and the drip chamber, such that fluid flowing through the fluid flow bypass path bypasses the drip chamber.
Two bypass branches adjacent respective ports
The fluid flow bypass path includes a first bypass branch fluidly connected to the direct flow lumen adjacent the first port and a second bypass branch fluidly connected to the direct flow lumen adjacent the second port.
Fluid pressure annulus between bypass branches
A fluid pressure annulus between and fluidly connected to the first bypass branch and the second bypass branch in the fluid flow bypass path.
Compliant region positioned between bypass connection and drip chamber
A first compliant region is positioned between a first connection to the first bypass branch and the drip chamber.
Third compliant region enabling occlusion of a bypass branch
A third compliant region is located in the first bypass branch in the direct flow lumen to enable a draw fluid control valve to occlude the first bypass branch.
Retaining previously sent donor fluid in the drip chamber during subsequent draws
The soft cassette maintains a portion of previously sent donor fluid in the drip chamber during a subsequent draw when the fluid passes through a fluid flow bypass path.
Overall claim coverage centers on a soft cassette direct-flow lumen that uses compliant regions with pinch valves, an interposed drip chamber, and a fluid-flow bypass path that bypasses the drip chamber, with dependent refinements that add bypass branch architecture, a fluid pressure annulus, placement of compliant regions relative to bypass connections, occlusion of a bypass branch via a draw fluid control valve, and retention behavior of previously sent donor fluid in the drip chamber during subsequent draws.
Stated Advantages
Reduced donation time attributable to maintaining centrifuge speed while returning non-desired components (e.g., ~30% reduction in donation time).
Documented Applications
Use in an apheresis system with blood component collection set and donor processing, including plasma separation while separated components are pushed back to the donor without stopping centrifugation.
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