Non-occluding intra vascular blood pump providing reduced hemolysis
Inventors
Groß-Hardt, Sascha • Kaufman, Tim • Clifton, William L. • Hertzog, Benjamin A. • Heuring, Jason J.
Assignees
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Publication Number
US-12078192-B2
Publication Date
2024-09-03
Expiration Date
Abstract
A non-occluding intravascular pump comprises a shroud providing an inlet for incoming blood flow and an outlet for outgoing blood flow, wherein the shroud is a cylindrical housing; an impeller positioned within shroud, wherein a central axis of the shroud and impeller are shared; a motor coupled to the impeller, wherein the motor rotates the impeller to causes blood to be drawn through the inlet and output to the outlet, and the motor is centrally disposed and shares the central axis with the shroud and the impeller; and a plurality of pillars coupling the motor to the shroud, wherein the pillars secure the shroud in close proximity to the impeller. Various design features of the pump may be optimized to reduce hemolysis, such as, but not limited to, inlet length, impeller design, pillar angle, and outlet design.
Core Innovation
The invention is a blood pump having a central axis, including a shroud extending generally along the central axis with an inlet for incoming blood flow and an outlet for outgoing blood flow. An impeller is positioned within the shroud and extends generally along the central axis, and a motor including a motor body disposed proximal to and coupled with the impeller is configured to impart rotation to the impeller. A stator hub disposed adjacent the motor body has a flaring radially outward surface in a proximal direction from a distal portion disposed at or within the shroud to a proximal portion spaced away from the shroud, and the stator hub is stationary when rotation is imparted to the impeller.
A pillar is coupled to the shroud at the outlet and to the motor body, and the pillar extends along a non-parallel orientation relative to the central axis. In one described configuration, a length of the pillar between the first end and the second end is unconnected to the stator hub and the pillar is disposed non-parallel to the central axis. In another described configuration, the pillar and shroud comprise contiguous uninterrupted portions of a thin cylindrical shape, with the pillar spaced apart from the flared surface and disposed non-parallel to the central axis.
The disclosed pump is described as a non-occluding intravascular axial blood pump, using geometry design to reduce hemolysis by controlling flow behavior and shear-stress hotspots near the impeller and in the outlet region. The shroud and inlet/outlet geometry are characterized with features including a trumpeted shroud with a larger inlet than outlet, increased inlet length, and raked-back leading edges, and the design includes matched impeller-stator flare angles and controlled shroud-blade clearance.
Structural features such as the pillar and associated angled components are used to further manage turbulent flow detachment and the location and magnitude of shear-rate levels to reduce NIH. Evaluation is described using transient CFD simulations with hotspot and shear-stress analysis and Lagrangian hemolysis modeling using Heuser constants, followed by in vitro or flow-loop validation.
Claims Coverage
The partial content provides three independent claims (clm-00001, clm-00006, clm-00011). Across these claims, the coverage focuses on an axial shroud/inlet/outlet impeller-motor arrangement, a stationary flared stator hub positioned relative to the motor and shroud, and a non-parallel pillar structure connecting the shroud and motor, with dependent claims further refining pillar geometry and inlet-to-outlet sizing.
Axial shroud with inlet and outlet around an impeller-motor assembly
A shroud extending generally along the central axis with an inlet for incoming blood flow and an outlet for outgoing blood flow, an impeller positioned within the shroud extending generally along the central axis, and a motor including a motor body disposed proximal to and coupled with the impeller and configured to impart rotation to the impeller.
Stationary flared stator hub flaring radially outward in a proximal direction
A stator hub disposed adjacent the motor body and having a flaring radially outward in a proximal direction from a distal portion disposed at or within the shroud to a proximal portion spaced away from the shroud, the stator hub being stationary when rotation is imparted to the impeller by the motor.
Non-parallel pillar coupling the shroud at the outlet to the motor body with an unconnected mid-length
A pillar having a first end coupled with a proximal portion of the shroud at the outlet of the shroud, the pillar extending to a second end opposite to the first end, the second end coupled to the motor body, a length of the pillar between the first end and the second end being unconnected to the stator hub, the pillar disposed non-parallel to the central axis.
Contiguous uninterrupted thin cylindrical pillar and shroud with a spaced-apart non-parallel pillar
A pillar and shroud comprising contiguous uninterrupted portions of a thin cylindrical shape, with the pillar spaced apart from the flared surface and disposed non-parallel to the central axis.
Pillar disposed outside the shroud supporting the shroud around the impeller
A pillar disposed outside of the shroud and extending from a proximal portion of the shroud to the motor body, the pillar disposed non-parallel to the central axis of the blood pump and supporting the shroud around the impeller.
Across the independent claims, the core structural coverage is an axial blood pump with a shroud defining an inlet and outlet around an impeller driven by a motor, together with a stationary stator hub having a flared radially outward surface extending from a distal portion at or within the shroud to a proximal portion spaced away. The claims further cover a pillar that connects the shroud to the motor and is disposed non-parallel to the central axis, including configurations where the pillar has an unconnected mid-length relative to the stator hub or where the pillar and shroud form contiguous uninterrupted thin cylindrical portions.
Stated Advantages
Reduction in hemolysis by controlling shear stress hotspots and shear stress levels associated with the impeller and flow path.
A claimed 78% NIH improvement while maintaining hydraulic output/efficiency.
Reduced shear stress and management of turbulent flow detachment near relevant regions to lower hemolysis-related metrics.
Documented Applications
Use as a non-occluding intravascular axial blood pump for pumping blood in an intravascular location, including reference to operation associated with the descending aorta and series operation with left ventricle.
Evaluation and validation using in vitro/flow-loop pump performance and comparison against a reference pump and described prototypes under pump performance testing.
Mention of clinical context including NYHA Class III/early IV patients associated with operation conditions discussed in the disclosure.
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