Compliant Mitral Valve Expander for Single Ventricle Growth
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Solution Overview
Problem
Current treatments for single-ventricle patients are largely palliative and focus on maintaining the health of a systemic single ventricle, with limited strategies for restoring biventricular or one-and-a-half ventricle circulation, relying on mechanical circulatory support devices and cardiac transplantation, which pose risks and donor heart limitations.
Innovation Solution
A compliant mitral valve expander device with springs and anchors is implanted to increase blood flow and stimulate ventricular growth, using bio-absorbable materials for incremental expansion, tested on an explanted fetal bovine heart with 25% annular expansion, designed to induce tissue growth in hypoplastic ventricles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If mechanical circulatory support devices are used for biventricular restoration, then cardiac function can be supported, but the risk of thrombolytic events increases
Solution Approach 1:
The patent replaces mechanical circulatory support devices with a biological growth induction system. Instead of using mechanical pumps and extracorporeal support that carry thrombolytic risks, the invention uses a compliant expander device that mechanically stimulates the hypoplastic ventricle to grow naturally through controlled stress application, thereby eliminating the need for long-term mechanical support and associated thrombosis risks
Solution Approach 2:
The invention changes the approach from maintaining cardiac function through external mechanical support to restoring function through biological growth. The compliant expander applies controlled mechanical stress to induce physiological changes in the ventricular myocardium, promoting hypertrophy and growth, thereby transforming the treatment paradigm from palliative support to curative restoration
2Reliability
If cardiac transplantation is performed for biventricular restoration, then cardiac function can be restored, but donor heart availability is limited
Solution Approach 1:
The patent enables the patient's own hypoplastic ventricle to serve its function again by inducing it to grow to adequate size. The compliant expander device stimulates the native myocardium to undergo hypertrophy and structural remodeling, allowing the ventricle to restore biventricular circulation without requiring external donor hearts, thereby making the treatment self-sufficient and eliminating donor dependency
Solution Approach 2:
Instead of discarding the hypoplastic ventricle as non-functional and replacing it with a donor heart, the invention recovers the functional potential of the native ventricle through growth induction. The compliant expander transforms the previously inadequate ventricle into a functional pumping chamber, thereby recovering and utilizing the patient's own cardiac tissue rather than replacing it
3Duration of action of stationary object
If current surgical palliation is used to maintain single ventricle function, then the systemic ventricle can be maintained, but biventricular restoration is not achieved
Solution Approach 1:
The patent applies preliminary mechanical stimulation to the hypoplastic ventricle during the palliative period to induce growth before biventricular restoration is attempted. The compliant expander is implanted during initial palliation surgery and continuously stimulates the ventricle to grow, preparing it for future functional restoration and transitioning the circulation from single to biventricular configuration
Solution Approach 2:
The invention introduces dynamic growth potential into the previously static palliative treatment. The compliant expander device adapts to the growing ventricle and provides continuous mechanical stimulation that promotes ongoing hypertrophy and functional development, thereby dynamically evolving the circulation from single ventricle toward biventricular configuration rather than maintaining a fixed palliative state
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 induces ventricular chamber growth, potentially restoring a healthy bi-ventricular cardiac system by increasing blood flow and applying controlled mechanical stimuli to myocardial tissue, addressing the limitations of existing treatments.
Implementation Method 1
a plurality of springs with respective springs coupled to adjacent anchors around a perimeter of the annular configuration to bias the anchors to expand radially outwardly
Implementation Method 2
This device also features bio-absorbable material that will allow for the incremental expansion of the device every few weeks over several months
Data Source
AI summary
Devices and methods are provided for inducing ventricular growth in a single ventricle patient that include a plurality of anchors spaced apart from one another in an annular configuration; a plurality of springs with respective springs coupled to adjacent anchors around a perimeter of the annular configuration to bias the anchors to expand radially outwardly; and one or more elongate elements extending around the perimeter between the anchors to limit radial expansion of the anchors.