Direct Connect Flush System for Heart Valve Delivery
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Solution Overview
Problem
Traditional cardiovascular treatments are often invasive, causing significant discomfort and long recovery times for patients, and existing less invasive therapies may not effectively address inefficiencies or failures in heart valve treatments.
Innovation Solution
A medical device system comprising a handle housing, an elongated outer sheath, and an inner member, allowing for percutaneous delivery and deployment of a replacement heart valve, which can be expanded and locked into place within the anatomy, reducing invasiveness and improving treatment efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional invasive cardiovascular treatments are used, then treatment efficacy is achieved, but patient discomfort and recovery time increase
Solution Approach 1:
The patent replaces traditional open-heart surgery and invasive mechanical procedures with a percutaneous delivery system that introduces the heart valve through a small catheter insertion site. The valve is delivered via a catheter through the femoral artery, eliminating the need for large incisions and direct surgical exposure of the heart, thereby reducing patient discomfort while maintaining treatment efficacy.
Solution Approach 2:
The patent introduces a catheter as an intermediary device to deliver the heart valve from the access site to the target location. The catheter acts as a mediator that transports the valve prosthesis through the vascular system, allowing the valve to be implanted without direct surgical access to the heart, thus reducing invasiveness and patient discomfort.
2Object-affected harmful factors
If percutaneous delivery system is used, then patient discomfort is reduced, but device complexity increases
Solution Approach 1:
The patent employs a nested structure where the heart valve prosthesis is contained within a catheter, which is inserted through a femoral artery access site. The valve is delivered through the catheter to the target location and then deployed. This nested arrangement allows complex valve delivery through a simplified percutaneous access point, reducing patient discomfort while managing device complexity through hierarchical organization.
Solution Approach 2:
The delivery system is segmented into distinct components: a catheter for delivery, a valve prosthesis for implantation, and a deployment mechanism. This segmentation allows each component to be optimized independently and facilitates percutaneous delivery while managing overall system complexity through modular design.
3Loss of time
If percutaneous delivery is used, then recovery time is reduced, but treatment efficacy may be compromised
Solution Approach 1:
The patent replaces traditional surgical valve replacement with a percutaneous delivery system that introduces the valve through a small catheter insertion site in the femoral artery. This substitution eliminates the need for open-heart surgery, significantly reducing recovery time while maintaining treatment efficacy through proper valve positioning and deployment mechanisms.
Solution Approach 2:
The valve prosthesis is designed with self-expanding capabilities upon deployment. The balloon-expandable or self-expanding mechanism allows the valve to automatically assume its functional configuration after being delivered through the catheter, ensuring treatment efficacy without requiring complex post-delivery assembly procedures, thus reducing recovery time.
Data Source
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AI summary
A medical device may include a handle housing (18) having a side wall defining an interior space and proximal and distal apertures (129b, 129a) extending through the side wall, an elongated outer sheath, an elongated inner member, a proximal flush port (128) disposed within the interior space and in fluid communication with the elongated inner member, and a distal flush port (126) disposed within the interior space and in fluid communication with the elongated outer sheath. A control knob (122) may be rotated to move the distal flush port within the interior space.