Balloon with Enlarged Central Region for Cylindrical Stent Expansion

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Solution Overview

Problem

Conventional balloon-expandable prosthetic heart valves often expand with flared ends, leading to non-cylindrical shapes that can interfere with valve performance and tissue damage during implantation and post-implantation.

Innovation Solution

A balloon design with enlarged central regions to exert increased expansion forces on stent-mounted prosthetic heart valves, ensuring a cylindrical or barrel-shaped expansion, reducing or eliminating flared ends, and optionally enhancing anchoring capabilities with conical flares.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Shape

If a conventional balloon is used to expand the stent-mounted prosthetic heart valve, then the valve can be deployed, but the ends of the stent flare outwards into a dog-bone shape which interferes with valve performance and can damage surrounding tissue

Engineering Contradiction:

Improvecylindrical shape of stent frameVSAvoidtissue damage from flared ends

Core Design Contradiction:

ShapeVSObject-affected harmful factors

Solution Approach 1:

The balloon is designed with non-uniform geometry, featuring an enlarged central region and reduced end regions. This local variation in balloon dimensions creates differential expansion forces: the enlarged central region exerts greater radial force to maintain cylindrical shape, while the reduced end regions exert less force to prevent flaring, thereby eliminating tissue damage from flared ends

Inventive Principle:

Principle #3Local quality

2Reliability

If the balloon is expanded uniformly, then the stent can be deployed, but the stent ends flare outwards creating a non-cylindrical shape that interferes with valve performance

Engineering Contradiction:

Improvevalve performanceVSAvoidflared ends of stent

Core Design Contradiction:

ReliabilityVSShape

Solution Approach 1:

The balloon features localized geometric variations with an enlarged central region and reduced end regions. This creates non-uniform expansion forces that counteract the natural flaring tendency at the stent ends, maintaining a cylindrical stent frame shape throughout deployment to ensure optimal valve performance

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The balloon's reduced end regions are designed to apply less expansion force at the stent ends, preliminarily counteracting the flaring tendency before it can develop. This preventive approach maintains cylindrical geometry and prevents performance interference from flared ends

Inventive Principle:

Principle #9Preliminary anti-action

3Stability of the object's composition

If the balloon has enlarged ends to retain the stent, then anchoring is improved, but the central region may not receive sufficient expansion force to maintain cylindrical shape

Engineering Contradiction:

Improveretention of stent on balloonVSAvoidcylindrical shape of stent

Core Design Contradiction:

Stability of the object's compositionVSShape

Solution Approach 1:

The balloon is designed with differentiated regions: reduced end regions that provide retention and anchoring of the stent, and an enlarged central region that provides sufficient expansion force to maintain cylindrical shape. This local quality variation simultaneously achieves both retention and cylindrical geometry

Inventive Principle:

Principle #3Local quality

4Device complexity

If the balloon exerts equal force throughout, then deployment is simple, but the stent frame develops flared ends requiring additional control mechanisms

Engineering Contradiction:

Improveballoon designVSAvoidflared ends

Core Design Contradiction:

Device complexityVSShape

Solution Approach 1:

The balloon incorporates geometric variations with an enlarged central region and reduced end regions, creating non-uniform expansion forces that prevent flaring. This design achieves cylindrical stent formation through the balloon geometry itself, avoiding the need for complex additional control mechanisms while maintaining relatively simple device architecture

Inventive Principle:

Principle #3Local quality

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 solution achieves a more cylindrical stent frame expansion, reducing interference and tissue damage, while allowing for controlled anchoring and improved valve function, enhancing the retention of the stent frame on the balloon.

Implementation Method 1

The balloon is configured to expand and exert a radially directed force against the stent frame so that the outflow diameter and inflow diameter are equal to or smaller than the central diameter

Methodology Applied

Scientific EffectRadial expansion force: Mechanical Force

Data Source

PatentUS20250009506A1Cylindrical implant and balloon

Publication Date: 2025.01.09 EDWARDS LIFESCIENCES CORP

AI summary

Disclosed herein are embodiments of a balloon shaped to have one or more enlarged regions to selectively increase expansion forces on an implant. For example, the balloon may have a central portion that is enlarged to exert more force on the center of a stent-mounted prosthetic heart valve. This overcomes the stent-mounted prosthetic heart valve's tendency to expand with flared ends. This forms a more cylindrical or barrel shaped stent frame during expansion of the balloon—reducing or eliminating the instance wherein the cylindrical stent frame has flared ends. Alternatively, the balloon may have conical flares placed to cause or enhance flared ends of the cylindrical implant to enhance its anchoring capabilities.