Shape Memory Annuloplasty Prosthesis for Mitral Valve Repair
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Solution Overview
Problem
Current treatments for mitral regurgitation often require open-heart surgery and cardiopulmonary bypass, which come with increased risks, costs, and recovery time, and there is a need for a minimally invasive percutaneous approach to address this condition effectively.
Innovation Solution
An annuloplasty prosthesis made of shape memory material, such as Nitinol, is used to reshape the mitral valve annulus by attaching to the valve annulus with self-retracting commissure legs and tissue attachment members, allowing for reduction in valve annulus size and improvement in leaflet coaptation, delivered via a catheter-based system that minimizes invasive procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart surgery with cardiopulmonary bypass is used to treat mitral regurgitation, then effective valve repair can be achieved, but patient risks, costs, and recovery time increase
Solution Approach 1:
The patent replaces the mechanical open-heart surgery system with a catheter-based delivery system that uses shape memory material properties. The annuloplasty prosthesis is delivered through a catheter and uses temperature-triggered shape memory effects to transform from a compressed delivery state to an expanded functional state, eliminating the need for cardiopulmonary bypass and open surgery while achieving the same valve repair effect
Solution Approach 2:
The patent utilizes parameter changes in shape memory material (Nitinol) that undergo phase transformation between austenite and martensite states based on temperature changes. The material is delivered in a compressed martensite state at lower temperature and automatically transforms to the expanded austenite state at body temperature, enabling minimally invasive delivery while achieving the desired annulus remodeling effect
2Shape
If traditional annuloplasty rings are used, then valve annulus remodeling is achieved, but the procedure requires invasive surgery
Solution Approach 1:
The patent employs a nested structure where the annuloplasty prosthesis is compressed within a delivery catheter, which itself is inserted through a peripheral vessel. The self-expanding frame and commissure legs are nested within the catheter during delivery and automatically expand to their functional configuration upon deployment, enabling minimally invasive access to the heart valve
Solution Approach 2:
The prosthesis utilizes self-expanding properties of shape memory material that automatically transform from a compressed delivery configuration to an expanded functional configuration upon exposure to body temperature. The commissure legs self-attach to the valve annulus through tissue ingrowth features, eliminating the need for complex surgical attachment procedures
3Ease of operation
If shape memory material is used for the prosthesis, then minimally invasive delivery is enabled, but device complexity increases
Solution Approach 1:
The patent divides the annuloplasty prosthesis into distinct functional segments: a self-expanding frame structure, multiple commissure legs with tissue attachment members, and integration with the ring body. This segmentation allows each component to be independently optimized for its specific function while collectively achieving the overall goal of minimally invasive valve repair
Solution Approach 2:
The patent employs composite construction combining shape memory alloy (Nitinol) with biocompatible materials for tissue attachment surfaces. The composite structure integrates the shape memory properties of Nitinol with specialized coating or surface treatments that promote tissue ingrowth and attachment, achieving both minimally invasive delivery and secure anchoring to the valve annulus
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
This approach enables minimally invasive repair of the mitral valve, reducing hospitalization time, costs, and health complications associated with traditional open-heart surgery, while effectively addressing mitral regurgitation by improving leaflet coaptation and reducing regurgitation.
Implementation Method 1
The ring body is made of shape memory material, such as Nitinol. When the ring body is stretched, the attachment member is attached to the annulus, and when the ring body retracts, the size of the annulus is reduced and remodeled
Implementation Method 2
the commissure legs are self-folding and/or self-furling such that when the legs are released they retract and/or fold/roll or furl into a contracted shape in the ventricle to secure the device to the valve
Data Source
AI summary
An annuloplasty prosthesis and delivery system for implanting the prosthesis adjacent an annulus of a heart valve having leaflets for adjusting the annulus to improve valve function includes a ring prosthesis made of shape memory material and having tissue attachment members which attach to the annulus in the atrium and commissural legs extending from the ring between the leaflets and secure against the underside of the valve in the ventricle. The prosthesis is carried via an orientation loop and attaches to the heart tissue such that when the prosthesis is manipulated and relaxed the annulus is adjusted to reduce or eliminate regurgitation.