Trans-apical Mitral Valve Spacer for Regurgitation Repair
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Solution Overview
Problem
Current treatments for mitral regurgitation often require invasive open-heart surgery, which is risky and not recommended until symptoms are severe, and there is a need for less invasive methods to address this common heart valve dysfunction.
Innovation Solution
A trans-apical mitral valve implant system that includes a spacer, shaft, and anchor assembly, allowing for minimally invasive delivery and anchoring within the heart, reducing regurgitation by interacting with native valve cusps without the need for cardiopulmonary bypass or open-heart surgery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open-heart surgery is performed to repair mitral regurgitation, then the valve can be properly repaired or replaced, but the patient faces high surgical risk and requires cardiopulmonary bypass
Solution Approach 1:
The patent introduces a transcatheter mitral valve prosthesis as an intermediary device that can be delivered through a catheter via a trans-apical approach. This intermediary solution allows valve replacement without requiring open-heart surgery or cardiopulmonary bypass, thereby reducing surgical risk while maintaining valve repair effectiveness. The prosthesis is delivered through a minimally invasive trans-apical approach, avoiding the need for sternotomy and cardiopulmonary bypass support.
2Reliability
If traditional open-heart surgery is used, then mitral regurgitation can be corrected, but the procedure is complex and requires prolonged hospitalization
Solution Approach 1:
The patent replaces the complex mechanical open-heart surgical system with a less invasive transcatheter delivery system. Instead of requiring sternotomy, cardiopulmonary bypass machinery, and complex surgical instrumentation, the invention uses a catheter-based delivery system that can be introduced through a trans-apical puncture. This substitution of the delivery mechanism significantly reduces procedural complexity while achieving the same therapeutic goal of correcting mitral regurgitation.
3Object-affected harmful factors
If a trans-apical approach is used for aortic valve replacement, then the procedure is less invasive, but there is no solution for concomitant mitral regurgitation treatment
Solution Approach 1:
The patent creates a universal treatment platform that can address both aortic and mitral valve pathologies through a single trans-apical approach. The system is designed to accommodate different valve prostheses (aortic and mitral) using the same minimally invasive access route. This multi-functional capability allows clinicians to treat one or both valve conditions in the same procedural setting, enhancing adaptability while maintaining low invasiveness.
4Reliability
If open-heart surgery is performed, then valve repair can be done, but the patient must be placed on a heart-lung machine
Solution Approach 1:
The patent extracts the essential function of valve replacement from the complex open-heart surgical context and delivers it through a simplified transcatheter approach. By removing the requirement for cardiopulmonary bypass and open chest surgery, the invention isolates and delivers only the critical therapeutic element (valve prosthesis implantation) through a minimally invasive catheter route. This extraction of the core function from the complex surgical package dramatically simplifies the procedure while preserving therapeutic efficacy.
Data Source
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AI summary
A trans-apical implant includes a spacer defining spacer cavity configured to be expanded from a retracted position, a shaft extending from the spacer, the shaft defining an inflation lumen fluidly coupled to the spacer cavity and configured to be fluidly coupled to an expansion medium source, and a spacer valve assembly disposed within at least one of the spacer or shaft, the spacer valve assembly configured to allow selectively allow an expansion medium to flow into the spacer cavity to be selectively expand the spacer from a retracted position to an expanded position.