Catheter Pump Stator for High Flow and Reduced Hemolysis

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Solution Overview

Problem

There is a need for improved mechanical circulatory support devices that can be inserted minimally-invasively and provide sufficient flow rates for treating acute heart failure while reducing the risk of hemolysis and thrombosis, with a focus on pumps that can be inserted through small percutaneous access sites and operate at reduced rotational speeds.

Innovation Solution

A catheter pump assembly featuring a collapsible impeller and stator design, allowing percutaneous insertion through small vascular access sites, with an impeller configured to pump blood at physiological rates at speeds less than 25K RPM and a flow modifying structure to minimize turbulence and enhance flow efficiency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a rotary blood pump is inserted into the body to assist the pumping function of the heart, then the level of potential support (flow) is increased, but the device complexity and invasiveness are increased

Engineering Contradiction:
Improveflow rateVSAvoiddevice complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The pump device is divided into separate functional components: an impeller for pumping, a stator for flow modification, and a drive mechanism. This segmentation allows each component to be optimized independently while reducing overall device complexity through modular design.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The impeller is positioned within the stator, creating a nested configuration where the rotating impeller is contained within the stationary stator structure. This nesting arrangement maximizes flow generation within a compact footprint, reducing device complexity while maintaining high productivity.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Productivity

If the impeller rotates at high speeds to generate sufficient flow, then the flow rate is improved, but the risk of hemolysis and thrombosis is increased

Engineering Contradiction:
Improveflow rateVSAvoidhemolysis and thrombosis risk
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The stator modifies flow parameters by redirecting and conditioning the blood flow path. This changes the flow characteristics to reduce turbulence and shear stress, thereby reducing hemolysis and thrombosis risk while maintaining high flow rates through optimized impeller rotation parameters.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The stator acts as an intermediary between the impeller and the outflow tract. It mediates the flow transition, smoothing out turbulent flow patterns generated by the impeller and reducing harmful effects on blood cells while maintaining efficient flow delivery.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If a collapsible impeller design is used for percutaneous insertion, then the ease of insertion is improved, but the device complexity is increased

Engineering Contradiction:
Improveease of insertionVSAvoiddevice complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The impeller is designed with dynamic collapsibility, allowing it to transition between an expanded operational state and a collapsed insertion state. This dynamic property enables percutaneous insertion through small access sites while maintaining full functionality during operation, balancing ease of insertion with operational effectiveness.

Inventive Principle:
Principle #15Dynamics

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The design achieves high flow rates, up to 4 Lpm or more, with reduced risk of hemolysis and thrombosis, enabling effective mechanical circulatory support for acute heart failure through minimally-invasive procedures.

Implementation Method 1

an impeller configured to pump blood in the vascular system at physiological rates at speeds of less than 25K RPM

Methodology Applied
Scientific EffectCentrifugal force: Centrifugal Force

Implementation Method 2

a stator disposed downstream of the impeller... with a flow modifying structure to minimize turbulence and enhance flow efficiency

Methodology Applied
Scientific EffectFlow modification: Turbulence

Data Source

PatentEP3797810B1Catheter pump assembly including a stator
Publication Date: 2025.09.03 TC1 LLC
  • EP3797810B1 patent drawingFigure 1
  • EP3797810B1 patent drawingFigure 2
  • EP3797810B1 patent drawingFigure 3A~3C

AI summary

A catheter pump assembly is provided that includes a proximal a distal portion, a catheter body, an impeller, and a flow modifying structure. The catheter body has a lumen that extends along a longitudinal axis between the proximal and distal portions. The impeller is disposed at the distal portion. The impeller includes a blade with a trailing edge. The flow modifying structure is disposed downstream of the impeller. The flow modifying structure has a plurality of blades having a leading edge substantially parallel to and in close proximity to the trailing edge of the blade of the impeller and an expanse extending downstream from the leading edge. In some embodiments, the expanse has a first region with higher curvature and a second region with lower curvature. The first region is between the leading edge and the second region.