Heart Valve Calcification Fracturing With Stabilizer and Impactor Arms

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Solution Overview

Problem

Heart valve defects such as calcification lead to impaired leaflet mobility, necessitating a method to fracture calcifications and increase pliability for improved heart function.

Innovation Solution

A catheter-based device with an expandable stabilizer and impactor arms is used to fracture calcifications in heart valves, employing mechanisms like impactor shafts, weights, and pneumatic energy to deliver controlled energy for fracturing, while maintaining valve function and minimizing tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a catheter-based device with expandable stabilizer and impactor arms is used to fracture calcifications, then leaflet pliability and mobility are improved, but device complexity increases

Engineering Contradiction:

Improveleaflet mobilityVSAvoiddevice complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The device is divided into multiple functional components: an expandable stabilizer with multiple arms that can be independently positioned, and separate impactor elements that can be delivered through the stabilizer structure. This segmentation allows each component to perform its specific function while maintaining overall system manageability despite the increased complexity required to treat calcified heart valves.

Inventive Principle:

Principle #1Segmentation

2Strength

If impactor arms are expanded outwards and locked to fracture calcification, then fracturing effectiveness is improved, but risk of tissue damage increases

Engineering Contradiction:

Improvefracturing energyVSAvoidtissue damage

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The impactor arms are designed to deliver localized mechanical energy specifically to the calcified portions of the valve leaflets. The expandable stabilizer positions the impactors precisely at the target site, allowing high-force impact to fracture calcifications while the surrounding healthy tissue remains protected by the stabilizer structure and experiences minimal mechanical stress.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The expandable stabilizer is deployed before the impactor arms are activated, creating a protective framework that cushions and constrains the mechanical forces. This pre-positioned stabilizer structure prevents uncontrolled propagation of mechanical energy to surrounding healthy tissues while allowing the impactors to deliver necessary fracturing energy to the calcified areas.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Adaptability or versatility

If the internal shaft is made movable to expand impactor arms, then device adaptability is improved, but device complexity increases

Engineering Contradiction:

Improvedevice adaptabilityVSAvoiddevice complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The internal shaft is designed as a dynamic component that can move relative to the impactor shaft, enabling the impactor arms to transition between a collapsed delivery state and an expanded working state. This dynamic mechanism allows the device to adapt to the anatomical constraints of the heart valve while providing the necessary mechanical advantage for fracturing calcifications, balancing versatility with manageable complexity through a single movable element.

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 device effectively fractures calcifications, enhancing leaflet mobility and preparing the valve for trans-catheter implantation, thereby improving heart function and reducing the risk of complications.

Implementation Method 1

the biasing device urges the weight towards the impactor arms with the sufficient energy

Methodology Applied

Scientific EffectElastic potential energy: Spring

Implementation Method 2

the biasing device includes a pneumatic energy source connected to a pressurized air source

Methodology Applied

Scientific EffectPneumatic pressure: Pressurisation

Implementation Method 3

the impactor arms, while in the expanded shape, to move towards the stabilizer with the sufficient energy so as to fracture a calcification

Methodology Applied

Scientific EffectImpact force: Impact Force

Data Source

PatentUS12471940B2Fracturing calcifications in heart valves

Publication Date: 2025.11.18 PI CARDIA

AI summary

A method for heart valve treatment includes providing a first heart valve treatment member movable along a first shaft portion, providing a second heart valve treatment member movable along a second shaft portion. The first and second heart valve treatment members are movable along the first and second shaft portions, respectively. The first heart valve treatment member is positioned on one side of a heart valve leaflet and the second heart valve treatment member is positioned on an opposite side of the heart valve leaflet. A portion of the heart valve leaflet is fracture by movement of the first heart valve treatment member with respect to the second heart valve treatment member.