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Publication Number

US-12161854-B2

Patent

Publication Date

2024-12-10

Expiration Date


Abstract

A blood flow assist system can include an impeller assembly including an impeller shaft and an impeller on the impeller shaft, a primary flow pathway disposed along an exterior surface of the impeller. The system can include a rotor assembly at a proximal portion of the impeller shaft. A secondary flow pathway can be disposed along a lumen of the impeller shaft. During operation of the blood flow assist system, blood can be pumped proximally along the primary flow pathway and the secondary flow pathway. The system can include a sleeve bearing distal the impeller. The system can include a drive unit having a distal end disposed distal a proximal end of the second impeller. The drive unit comprising a drive magnet and a drive bearing between the drive magnet and the impeller assembly.

Core Innovation

The invention relates to a percutaneous blood flow assist system that pumps blood proximally along two different pathways: a primary flow pathway along an exterior surface of an impeller component and a secondary flow pathway along a lumen of an impeller shaft. The secondary flow pathway extends from a distal end portion of the impeller shaft through a concave opening, with the rotational axis intersecting the secondary flow pathway within the lumen. Blood is pumped proximally along both pathways during operation of the blood flow assist system.

Rotation is imparted to the impeller shaft and impeller component by a drive unit. One arrangement places at least a portion of the drive unit distal the proximal end portion of the impeller shaft within a concave opening that includes an angled cavity extending radially inwardly and distally from a flange. The impeller component includes a flange extending radially outward from a proximal end portion of the impeller shaft, and vanes extending proximally from the flange, with the impeller component comprising a distal portion including a blade and a proximal portion disposed over the one or more driven magnets.

To manage blood interaction at the bearing interface, the system includes a sleeve bearing distal the impeller component with a bearing interface surface disposed circumferentially around the impeller shaft and extending within a bearing lumen. The disclosed sleeve-bearing structure is configured such that an exterior surface of the impeller shaft is cyclically exposed to blood as the shaft rotates, based on a particular bearing geometry including an angled boundary at a selected axial location. Additionally, the drive bearing is described with a concave opening that includes an angled cavity and, in refinements, a segmented cone drive bearing with distally-projecting segments and channels from a central hollow to wash the bearing interface.

Claims Coverage

The document includes two independent claims that define a dual-pathway percutaneous blood flow assist system with primary and secondary proximal blood pumping, magnetic drive via driven magnets and a drive unit, and a sleeve bearing configured for circumferential bearing interface interaction with cyclic blood exposure. Across the independent claims, the main inventive features are organized into core flow-path geometry, magnetic/drive-bearing arrangement, and sleeve-bearing interface geometry that relates to blood exposure and bearing washing via channels and a central hollow.

Dual proximal pumping with intersecting primary and secondary flow pathways

Blood is pumped proximally along a primary flow pathway along an exterior surface of the impeller component and a secondary flow pathway along a lumen of the impeller shaft, wherein the secondary flow pathway extends through the concave opening and the rotational axis intersecting the secondary flow pathway within the lumen so that blood is pumped proximally along both pathways during operation.

Concave opening with angled cavity for drive-unit placement and secondary flow routing

A drive unit configured to impart rotation to the impeller shaft and impeller component, with at least a portion of the drive unit positioned distal the proximal end portion of the impeller shaft within a concave opening, the concave opening comprising a continuous surface disposed about an angled cavity extending radially inwardly and distally from the flange, and the secondary flow pathway extending from the distal end of the lumen through the concave opening.

Drive magnets with lumen-based secondary pathway intersected by the rotational axis

One or more driven magnets positioned over an outside surface of the impeller shaft, together with an impeller component comprising an inside surface disposed on the outside surface of the impeller shaft, and a flow tube including a lumen extending from a distal end portion of the impeller shaft to a proximal end portion of the impeller shaft, wherein the secondary flow pathway extends through the concave opening and is intersected by the rotational axis within the lumen during operation.

Segmented cone sleeve-bearing interface with circumferentially disposed bearing interface surface

A sleeve bearing distal the impeller component, the sleeve bearing having a bearing interface surface disposed circumferentially around the impeller shaft extending within a bearing lumen of the sleeve bearing, with the bearing interface interacting with blood during operation and, in refinements, configured to cyclically expose an exterior surface of the impeller shaft to blood based on bearing geometry at a selected axial location.

Dual-impeller rotatable assembly with secondary flow along a central rotational axis

A pump housing and an impeller assembly disposed in the pump housing and configured to rotate relative to the pump housing, comprising a rotatable member with a first impeller and a second impeller spaced apart proximally, a lumen extending from an inlet of the shaft distal to a distal end of the blade along a longitudinal axis, a primary flow pathway between an exterior surface of the impeller assembly and the pump housing, and a secondary flow pathway along the lumen such that blood in the secondary flow pathway flows at a central rotational axis during operation, with blood pumped proximally along the primary and secondary flow pathways.

Non-parallel flange and concave opening with angled cavity for dual flow pathways

The second impeller comprises a flange coupled to or formed with a proximal end portion of the rotatable member, the flange extending non-parallel relative to the central rotational axis, and the lumen extends to a concave opening at the flange, the concave opening comprising a continuous surface disposed about an angled cavity extending radially inwardly and distally from the flange.

Across the independent claims, the claim coverage centers on a blood flow assist system that pumps proximally along both an exterior primary flow pathway and a lumen-based secondary flow pathway, driven by a drive unit with driven magnets and a concave opening that includes an angled cavity. The independent claim set further emphasizes a sleeve bearing with a circumferential bearing interface surface and, in refinements, bearing geometry that supports cyclic exposure of the shaft exterior to blood. In the second independent claim, the system is implemented with a dual-impeller rotatable assembly and a non-parallel flange defining a concave opening for the secondary-flow lumen.

Stated Advantages

Reduced recirculation by same-direction dual flow paths.

Surface-area versus point contact at the bearing interface.

Compact integrated rotor core.

Thrust support directionality.

Reduced thrombosis/hemolysis via cyclic exposure of the shaft to blood.

Documented Applications

Percutaneous insertion blood flow assist/pumping in a blood flow assist system with an impeller assembly and pump housing.

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