Adjustable Lollipop Valve Occluder for Regurgitation
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Solution Overview
Problem
Dysfunctional heart valves, such as those experiencing regurgitation due to malcoaptation or valve prolapse, require effective solutions to prevent blood flow backpressure, which current surgical methods can be complex and time-consuming to address.
Innovation Solution
A selectively adjustable apparatus with a lollipop-shaped body member featuring an expandable occluding member that can be adjusted in diameter and position to assist in closing native heart valve leaflets, minimizing regurgitation by coapting with the leaflets during the cardiac cycle, and anchored within the heart chamber.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical repair procedures (plication, chordal shortening, annuloplasty) are performed to treat regurgitant heart valves, then valve function is improved, but the procedure becomes complicated and time-consuming
Solution Approach 1:
The invention extracts the complex surgical repair procedures (annuloplasty, chordal replacement) and replaces them with a single implantable device that provides equivalent functional outcomes. The device is delivered percutaneously without requiring open-heart surgery, thereby simplifying the overall treatment approach while maintaining valve function improvement.
Solution Approach 2:
The patent introduces an intermediary device that acts as a mediator between the heart valve and the treatment goal. This device includes a support structure with anchoring elements and a leaflet engagement structure that works together to correct regurgitation, serving as an intermediate solution that avoids direct complex surgical manipulation of the valve structures.
2Reliability
If traditional surgical repair procedures are used to treat regurgitant heart valves, then regurgitation is corrected, but the treatment time increases
Solution Approach 1:
The device is prepared and sized before implantation, with the support structure and engagement elements pre-configured. This preliminary preparation allows for rapid deployment during the procedure, reducing overall treatment time while ensuring proper fit and function for correcting regurgitation.
Solution Approach 2:
The patent replaces traditional mechanical surgical procedures (suturing, chordal manipulation) with a device-based mechanical system that can be deployed more quickly. The self-expanding or balloon-expandable support structure with pre-formed anchoring elements eliminates time-consuming surgical steps while achieving the same therapeutic effect.
3Reliability
If the occluding member diameter is increased to improve leaflet coaptation, then regurgitation prevention is enhanced, but the device size and complexity increase
Solution Approach 1:
The occluding member is designed with adjustable diameter capability, allowing it to be dynamically resized to match the specific patient's valve anatomy. This dynamic adjustment ensures optimal leaflet coaptation and regurgitation prevention without requiring a one-size-fits-all large device, thereby maintaining device appropriateness while achieving reliable prevention.
Solution Approach 2:
The patent utilizes parameter changes in the occluding member diameter as a key design feature. By allowing the diameter parameter to be adjusted based on individual patient needs, the device achieves effective regurgitation prevention through optimized coaptation surface area without unnecessarily increasing overall device complexity or size.
Data Source
AI summary
An apparatus for treating regurgitation of blood through a diseased heart valve having at least two leaflets includes a lollipop-shaped body member having a proximal end portion, a distal end portion, and an intermediate portion extending between the end portions. The intermediate portion includes an expandable occluding member having an adjustable diameter so that, during at least a portion of the cardiac cycle, at least one of the heart leaflet coapts with a portion of the occluding member to mitigate or prevent regurgitation of blood through the diseased heart valve. The proximal end portion is physically connected to the occluding member and includes a connecting mechanism for operably mating with an adjustment member for adjusting the position and diameter of the occluding member within the diseased heart valve. The distal end portion includes an anchoring member for securing the apparatus in a heart chamber containing the diseased heart valve.