Expandable Catheter Pump Sheath Assembly for Aortic Valve Stability

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Solution Overview

Problem

Current mechanical circulatory support devices for acute heart failure, such as intra-aortic balloon pumps and rotary blood pumps, face challenges in providing reliable and efficient support due to issues with component coupling under dynamic loads and the need for compact, efficient designs that can be deployed minimally invasively.

Innovation Solution

A catheter pump system with an expandable impeller assembly and a catheter body featuring a flexible middle section and harder end sections, along with a robust mechanical interface, allows for secure coupling and flexible positioning across the aortic valve, enabling high flow rates and stability during use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If a fixed cross-section ventricular assist device is designed to provide partial or near full heart flow rate, then the flow rate capability is improved, but the device becomes too large to be advanced percutaneously

Engineering Contradiction:
Improveflow rate capabilityVSAvoiddevice size
Core Design Contradiction:
ProductivityVSLength of moving object

Solution Approach 1:

The device is divided into multiple sections along its longitudinal axis, with each section having different stiffness characteristics. The proximal and distal sections are relatively stiff to provide structural support for high flow rates, while the intermediate section is flexible to enable percutaneous advancement through blood vessels.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different sections of the catheter body are assigned different mechanical properties (stiffness) according to their specific functional requirements. The proximal and distal sections have higher stiffness to maintain structural integrity under high flow conditions, while the intermediate section has lower stiffness to facilitate navigation through the vasculature.

Inventive Principle:
Principle #3Local quality

2Ease of operation

If the catheter body is made flexible to enable percutaneous deployment, then the ease of deployment is improved, but the stability and support under dynamic loads deteriorates

Engineering Contradiction:
Improveease of deploymentVSAvoidstability under dynamic loads
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The catheter body is segmented into multiple zones with different stiffness properties. The flexible intermediate section enables easy deployment and navigation, while the stiff proximal and distal sections provide the necessary stability and support to withstand dynamic loads during operation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The catheter body exhibits dynamic mechanical properties that adapt to different operational phases: flexible during deployment and navigation, and stiff during operation to provide stable support under load.

Inventive Principle:
Principle #15Dynamics

3Reliability

If a robust mechanical interface is used to secure component coupling, then the reliability is improved, but the device complexity increases

Engineering Contradiction:
Improvecomponent coupling reliabilityVSAvoidmechanical interface complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

A flexible intermediate section acts as a mechanical interface between the proximal and distal sections. This flexible membrane provides a robust coupling mechanism that accommodates dynamic loads while maintaining component security, avoiding the need for complex rigid mechanical connectors.

Inventive Principle:
Principle #30Flexible shells and thin films

Data Source

PatentUS11964119B2Sheath assembly for catheter pump
Publication Date: 2024.04.23 TC1 LLC
  • US11964119B2 patent drawing
  • US11964119B2 patent drawing
  • US11964119B2 patent drawing

AI summary

A catheter pump includes a catheter body having at least one lumen therethrough, and comprising a distal end and a proximal end. An expandable impeller assembly includes an expandable impeller and an expandable cannula coupled to the distal end of the catheter body and housing the expandable impeller, the expandable cannula comprising a substantially straight segment having a distal inlet and a proximal outlet, the substantially straight segment configured to straddle an aortic valve. The catheter body comprises a proximal vessel contact zone and a distal vessel contact zone that are each proximal to the substantially straight segment, the proximal vessel contact zone and distal vessel contact zone configured to provide a force against an aortic arch to stabilize the expandable impeller assembly across the aortic valve.