Memory Shape Heart Valve for Minimally Invasive Delivery
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Solution Overview
Problem
Current heart valve replacement methods require invasive open-chest surgeries, are not optimally sized for individual patients, and may not adapt to growth or changes in heart shape and size, leading to insecure fits and repeated surgeries.
Innovation Solution
A heart valve system using a memory shape element, such as a rolled metal ply or helically-rolled ribbon, encased in silicone, which can be delivered via intravenous catheter and expands to securely fit a wide range of patients, maintaining a secure fit over time and adapting to growth, with optional supplemental coils for enhanced stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-chest surgery is used for heart valve replacement, then the valve can be securely installed, but the patient faces long recovery times, infection risk, and higher mortality
Solution Approach 1:
The valve is nested within a delivery catheter in a compressed state, allowing it to be delivered through a vein to the heart valve site without open-chest surgery. The valve then expands from its compressed delivery state to its functional expanded state, achieving secure installation through the nesting and expansion mechanism.
Solution Approach 2:
The valve utilizes temperature-dependent shape memory effects to change its physical parameters (shape, size, rigidity) in response to body temperature. When exposed to body temperature after delivery, the valve transitions from a compressed delivery configuration to an expanded functional configuration, achieving secure fit without invasive surgery.
2Ease of manufacture
If a fixed-size replacement valve is used, then the installation process is simplified, but the valve may become incorrectly sized over time due to patient growth and heart changes
Solution Approach 1:
The valve is designed with dynamic shape memory properties that allow it to change its configuration in response to temperature changes. The valve can be delivered in a compressed state, expanded to a first functional size, and later re-heated to transform to a second different size, providing adaptability to patient growth and heart changes while maintaining installation simplicity.
Solution Approach 2:
The valve utilizes temperature-dependent shape memory effects to change its physical parameters (shape, size, rigidity) in response to body temperature. When exposed to body temperature after delivery, the valve transitions from a compressed delivery state to an expanded functional state, achieving secure fit without invasive surgery.
3Duration of action of stationary object
If mechanical valves are used, then the valve durability is extended, but the valve is rigid and noisy, requiring multiple surgeries for growing patients
Solution Approach 1:
The valve utilizes temperature-dependent shape memory effects to change its physical parameters (shape, size, rigidity) in response to body temperature. When exposed to body temperature after delivery, the valve transitions from a compressed delivery state to an expanded functional state, achieving secure fit without invasive surgery.
Solution Approach 2:
The valve is designed with dynamic shape memory properties that allow it to change its configuration in response to temperature changes. The valve can be delivered in a compressed state, expanded to a first functional size, and later re-heated to transform to a second different size, providing adaptability to patient growth and heart changes while maintaining installation simplicity.
4Adaptability or versatility
If biological valves are used, then the valve is flexible and adaptable to growth, but the valve operation is noisy and has shorter lifespan
Solution Approach 1:
The valve combines shape memory alloy materials with biological valve leaflet materials to create a composite structure. The shape memory alloy provides the flexible, adaptable framework that can change size with patient growth, while the biological leaflets provide silent, natural valve operation. This composite construction achieves both flexibility/adaptability and silent operation with extended durability.
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
Enables minimally invasive valve replacement with a secure, adaptable fit that mimics biological valves' flexibility and longevity, reducing surgical risks and the need for multiple surgeries by using temperature-driven expansion and a silent operation.
Implementation Method 1
the memory shape element of the valve would be sized or otherwise bent or manipulated into a desired shape to fit an intended valve to repair for the patient, and then heated to a sufficiently high temperature that the memory shape element becomes 'set' to this memory shape
Implementation Method 2
The ambient temperature of the body causes the valve to expand toward its pre-set memory-shape
Data Source
AI summary
A replacement heart valve comprising a memory shape element. The various embodiments use internal body heat to seat and retain the valve within a blood passage. The element can be provided in a variety of shapes and sizes, and is at least partially encased within an inert and pliant encasing material. The encasing material is one that is adapted to be contiguous with the structure of the valve nozzle or backflow-resistant leaf structure, and may be used in combination with existing stents or an incorporated stent, including ones having a structure similar to conventional stents.