Piezochromatic Feedback Indicators for Heart Valve Delivery
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Solution Overview
Problem
Current prosthetic heart valve delivery systems lack effective feedback mechanisms for clinicians, leading to potential misplacement and complications during transcatheter procedures, and existing sensors are costly.
Innovation Solution
Incorporation of piezochromatic feedback indicators made from polymers with pigments that change color in response to force or strain, providing visual feedback on the delivery device to indicate improper use, misloading, or shipping damage, and distinguishing genuine from counterfeit devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If visual feedback indicators are incorporated into the delivery device, then placement accuracy and device handling are improved, but device complexity increases
Solution Approach 1:
The patent incorporates piezochromatic feedback indicators that change color in response to force or strain applied to the delivery device. These indicators are integrated into the delivery system to provide visual feedback to clinicians during valve placement, indicating improper use, misloading, or shipping damage through color changes without requiring complex electronic sensors or additional mechanical components.
2Loss of information
If piezochromatic indicators are integrated into the delivery device, then feedback capability is improved, but manufacturing complexity increases
Solution Approach 1:
The piezochromatic indicators are merged with existing components of the delivery device, such as the outer sheath or capsule, rather than being separate add-on elements. This integration allows the feedback functionality to be incorporated into the manufacturing process of existing components, reducing overall manufacturing complexity while maintaining feedback capability.
3Strength
If the outer sheath is made robust to resist radial forces, then structural strength is improved, but flexibility to traverse tortuous paths deteriorates
Solution Approach 1:
The delivery device incorporates sections with different mechanical properties along its length. The outer sheath is designed with varying wall thicknesses or material compositions in different segments, allowing the distal portion to be more flexible for navigating tortuous vasculature while maintaining sufficient strength in proximal sections to resist radial forces from the compressed valve.
Solution Approach 2:
The outer sheath is constructed using composite materials that combine the benefits of strength and flexibility. By layering different materials with complementary properties, the sheath achieves sufficient radial strength to contain the compressed valve while maintaining the flexibility needed to traverse the tortuous path to the native valve annulus site.
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 enhances the accuracy of prosthetic heart valve placement by providing visual feedback to clinicians, reducing the risk of complications and ensuring proper device handling, while also preventing reuse of used devices and identifying counterfeit products.
Implementation Method 1
piezochromatic feedback indicators made from polymers with pigments that change color in response to force or strain
Data Source
AI summary
Heart valve delivery systems and methods for providing a clinician with feedback during a stented prosthetic heart valve delivery procedure. Feedback is provided using piezochromatic indicators incorporated into elements of the delivery device, such as the handle assembly, shaft assembly and capsule to indicate when detrimental forces, or forces nearing those that are detrimental, are being applied to the delivery device during the prosthetic heart valve loading, delivery or deployment procedure. Other embodiments incorporate a feedback indicator to indicate that a delivery device has previously been used and is not in a new condition.