Percutaneous Delivery Catheter Stabilization in the Aortic Arch

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Solution Overview

Problem

Delivering and maintaining the position of balloon members and/or prosthetic devices within the native heart valve during heart valve procedures is challenging due to environmental conditions such as blood flow, pressure changes, and heart movement.

Innovation Solution

A delivery system with a catheter shaft and tension members, expansion members, and pull wires that stabilize the catheter shaft by wedging it within the aortic arch, using features like increased stiffness, articulating areas, and expandable balloon members to maintain position and facilitate procedures like valvuloplasty and prosthetic valve deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a balloon member or prosthetic device is delivered within the native heart valve, then heart valve treatment is enabled, but maintaining stable position during the procedure becomes difficult due to blood flow, pressure changes, and heart movement

Engineering Contradiction:

Improveposition stabilityVSAvoidenvironmental disturbances

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The catheter shaft is pre-configured with articulating areas and tension members that enable it to actively adjust and wedge itself within the aortic arch before the balloon expansion occurs. This preliminary positioning action establishes stability against blood flow and heart movement before the critical treatment phase begins

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The catheter shaft incorporates articulating areas that allow dynamic adjustment of the shaft's configuration. Tension members can be adjusted to change the degree of articulation, enabling the catheter to adapt its shape to wedge securely within the aortic arch and maintain position despite changing environmental conditions during the procedure

Inventive Principle:

Principle #15Dynamics

2Stability of the object's composition

If the catheter shaft is made stiffer to maintain position, then positioning stability improves, but the ability to navigate through vessels and articulate within the aortic arch deteriorates

Engineering Contradiction:

Improvecatheter shaft stabilityVSAvoidcatheter articulation

Core Design Contradiction:

Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The catheter shaft is divided into multiple segments with different stiffness characteristics. The proximal portion has higher stiffness for stability, while the distal portion contains articulating areas with lower stiffness for navigation and positioning. This segmentation allows each section to perform its specialized function without compromising the other

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different portions of the catheter shaft are given different mechanical properties. The proximal shaft maintains higher stiffness for overall stability, while the distal articulating areas have reduced stiffness to enable bending and wedging actions. This local differentiation of mechanical properties resolves the contradiction between stability and adaptability

Inventive Principle:

Principle #3Local quality

3Measurement precision

If tension members are used to articulate the catheter shaft for wedging, then positioning precision improves, but device complexity increases

Engineering Contradiction:

Improveplacement precisionVSAvoidcatheter structure

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The tension members are designed to be adjusted by the operator in response to real-time feedback from the procedure. The catheter's articulating areas self-adjust to wedge positions based on the natural geometry of the aortic arch and the forces applied by the tension members, reducing the need for complex external control mechanisms

Inventive Principle:

Principle #25Self-service

Data Source

PatentUS20250302616A1Stability device for use with percutaneous delivery systems

Publication Date: 2025.10.02 EDWARDS LIFESCIENCES CORP

AI summary

An expansion device for a prosthetic implant comprises a first balloon and a second balloon arranged radially outward of the first balloon. The expansion device can be configured to expand from an uninflated state to a first inflated state for stabilizing the prosthetic implant, and from the first inflated state to a second inflated state for radially expanding the prosthetic implant. In the first inflated state, the first balloon and the second balloon can each have radially enlarged distal end portions and radially enlarged proximal end portions relative to their respective center portions. In the second inflation state, a center portion of the second balloon radially expands radially beyond the expandable distal and proximal end portions of the first balloon while a center portion of the first balloon remains radially smaller than the expandable distal and proximal end portions of the first balloon.