Shape Memory Heart Valve Annuloplasty Ring
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Solution Overview
Problem
Current heart valve repair and replacement methods, particularly annuloplasty procedures, are time-consuming and inefficient, often requiring tedious suturing and may result in suboptimal positioning of prosthetic rings, which can prolong surgery and compromise valve function.
Innovation Solution
A device utilizing shape memory materials and biodegradable restraining members to conform to and remodel the heart valve annulus, allowing for controlled shape changes to improve valve function, with the support members being easily positioned and anchored to the valve tissue, either through temperature activation or mechanical expansion, facilitating efficient attachment and remodeling of the valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional suture technique is used for annuloplasty, then the prosthetic ring can be attached to the valve annulus, but the surgery time is prolonged and the positioning may be suboptimal
Solution Approach 1:
The prosthetic ring is pre-shaped to match the anatomical geometry of the valve annulus, allowing it to be positioned correctly in a single step without requiring time-consuming suturing adjustments. The pre-formed shape ensures optimal positioning is achieved immediately upon implantation.
Solution Approach 2:
The traditional mechanical suture-based attachment system is replaced with a shape-memory-based positioning system. The shape memory material automatically conforms to the annulus geometry through thermal or mechanical activation, eliminating the need for manual suture placement and adjustment.
2Stability of the object's composition
If the support member is made rigid to maintain shape, then structural stability is improved, but the ability to conform to the valve annulus shape is reduced
Solution Approach 1:
The support member transitions from a flexible state during implantation to a rigid state after deployment. The shape memory material allows the ring to be deformed into the desired configuration, then locked into that shape through phase transformation, providing both conformability during positioning and structural stability during function.
Solution Approach 2:
The shape memory material undergoes a phase transition (e.g., austenite-martensite transformation) that enables the support member to change from a soft, conformable state to a rigid, stable state. This phase change allows the ring to adapt to the annulus shape and then maintain that shape under physiological loads.
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 faster, more reliable heart valve repair by allowing for precise anchoring and remodeling of the valve annulus, reducing surgery time and improving valve function by ensuring proper leaflet closure, while the biodegradable components minimize tissue reaction and facilitate integration.
Implementation Method 1
a support member at least partially formed from a shape memory material operable to assume an activated shape and an inactivated shape... the support member is configured to abut one side of the valve and is arranged to conform to the shape of at least a part of the valve annulus upon said shape memory material assuming said activated shape
Implementation Method 2
The restraining member is formed of a biodegradable material to be degraded when the device is implanted in a patient, wherein degradation of the restraining member removes the restraining action and allows the support member to assume a desired, altered course
Data Source
AI summary
A device for improving the function of a heart valve comprises: a support member formed from a shape memory material, and a restraining member providing a restraining action on a course of the support member. The support member may abut one side of the valve conforming to the shape of the valve annulus upon said shape memory material assuming an activated shape while the restraining member restrains the course of the support member. The restraining action is removable for allowing the support member to assume a desired, altered course. The restraining member may be biodegradable to be degraded within a patient or may be detachable from the support member to be withdrawn. The support member according to another embodiment presents a shape change in that an increased cross-section is associated with a shortened length of the support member. The support member according to yet another embodiment has a first and a second activated shape.