Support structures for intravascular blood pumps

Inventors

Clifton, WilliamEarles, Ronald G.HERTZOG, BenjaminHeuring, Jason J.Durst, Christopher A.BENAVIDES, OmarFain, Eric S.

Assignees

Procyrion Inc

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Publication Number

US-11697017-B2

Patent

Publication Date

2023-07-11

Expiration Date


Abstract

An improved system for supporting (e.g., localization and/or positioning of) intravascular devices discussed herein provides for example a multi-element arrangement. A set of struts optionally projects from the intravascular device and contacts the vessel walls. The localization and positioning of the pump may be provided by the struts and/or by use of a tether opposing a propulsive force to ensure localization.

Core Innovation

The invention relates to an intravascular blood flow assist system in which a pump includes a pump housing with an inlet port and a support structure comprising a plurality of self-expanding struts coupled to or formed with the pump housing. The support structure has an expanded configuration in which the plurality of struts extend outwardly relative to the pump housing, and a collapsed configuration in which the pump is disposed in a sheath.

In the collapsed configuration, the invention defines a lateral-dimension relationship measured from a central longitudinal axis of the pump to radially-outer surfaces of the struts, such that the struts have a lateral dimension that is no more than a lateral dimension of the pump housing. The support structure is coupled to or formed with the pump housing adjacent to the inlet port when disposed in the sheath.

The invention further includes distal convex contact pads that are configured to contact a blood vessel wall to maintain spacing between the pump housing and the vessel wall, with optional hooks/tines referenced for atraumatic engagement. The struts can include knees/inflection zones to prevent sheath contact and control folding/collapse while accommodating a staged or sequenced strut collapse.

An optional tether extends from the pump housing and is configured to oppose propulsive/thrust loads to maintain pump positioning, with a conductor-bearing tether referenced to convey power to a motor/impeller. The system is described as maintaining localization via tether-thrust balance while limiting or preventing pump contact with the vessel wall.

Claims Coverage

The independent claims cover a blood flow assist system where a pump housing with an inlet/port is coupled to a multi-strut support structure that transitions between an expanded configuration and a collapsed configuration inside a sheath, with a defined lateral-dimension constraint and, in some refinements, vessel-wall spacing features and load/electrical management via a tether. Across the independent claims, the number of inventive features emphasized includes: strut-based self-expanding support with expanded/collapsed configurations; sheath-contained collapsed geometry defined by lateral-dimension comparisons; coupling of the support structure to the pump housing in the collapsed configuration; and (in dependent refinements) convex contact pads and tether-based load opposition/power via a conductor.

Self-expanding strut support with expanded and sheath-collapsed configurations

A blood flow assist system comprising a pump having a pump housing with an inlet port, and a support structure comprising a plurality of struts coupled to or formed with the pump housing, wherein the support structure has an expanded configuration in which the plurality of struts extend outwardly relative to the pump housing and a collapsed configuration in which the pump is disposed in a sheath.

Collapsed configuration lateral-dimension constraint versus the pump housing

In the collapsed configuration, a lateral dimension of at least a portion of each strut as measured from a central longitudinal axis of the pump to a radially-outer surface of the strut is no more than a lateral dimension of the pump housing as measured from the central longitudinal axis of the pump to a radially outer surface of the pump housing.

Support structure coupled to the pump housing adjacent to the inlet port when collapsed

The support structure is coupled to or formed with the pump housing adjacent to the inlet port when the support structure is in the collapsed configuration within the sheath.

Ported pump housing with struts at the port and lateral-dimension constraint versus tissue-facing pump surface

A blood flow assist system comprising a pump having a central longitudinal axis and a pump housing comprising a port through which blood flows, and a support structure comprising a plurality of struts having respective proximal ends coupled to or formed with the pump housing adjacent to the port, wherein the support structure has an expanded configuration and a collapsed configuration in which the pump housing is coupled to or formed with the support structure while disposed in a sheath, and in the collapsed configuration at least a portion of a radially-outer surface of each strut configured to face tissue has a lateral dimension no more than a lateral dimension of the pump housing as measured from the central longitudinal axis of the pump to a surface of the pump housing configured to face tissue.

Tissue-facing radially-outer strut lateral dimension limited to pump housing tissue-facing surface lateral dimension

In the collapsed configuration, at least a portion of a radially-outer surface of each strut configured to face tissue during operation has a lateral dimension as measured from the central longitudinal axis of the pump to the radially-outer surface that is no more than a lateral dimension of the pump housing as measured from the central longitudinal axis of the pump to a surface of the pump housing configured to face tissue during operation.

Struts spaced from the sheath inner wall in the collapsed configuration

In the collapsed configuration, the support structure is coupled to or formed with the pump housing and respective distal ends of the plurality of struts are spaced apart from an inner wall of the sheath.

Inside-surface-faced strut lateral-dimension constraint versus sheath-facing pump housing surface

In the collapsed configuration, at least a portion of each strut configured to face an inside surface of the sheath has a lateral dimension as measured from the central longitudinal axis of the pump housing to the portion of each strut facing the inside surface of the sheath that is no more than a lateral dimension of a surface of the pump housing configured to face the inside surface of the sheath.

Across the independent claims, the coverage centers on a pump with a pump housing port/inlet port coupled to a multi-strut support structure that transitions between an expanded configuration and a collapsed configuration in a sheath, with a defined “no more than” lateral-dimension relationship for struts versus the pump housing (including tissue-facing or sheath-inside-facing surfaces). The claims also include coupling of the support structure adjacent to the inlet/port during collapse and, in the sheath-collapsed state of claim 20, spacing of distal strut ends from the sheath inner wall.

Stated Advantages

Reduced device translation/rotation

Atraumatic/non-thrombogenic contact

Staged/controlled strut collapse

Ability to limit or prevent pump contact with the vessel wall while maintaining localization via tether-thrust balance

Documented Applications

Not explicitly described in patent.

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