Repositionable Prosthetic Heart Valve Delivery System
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Solution Overview
Problem
Current percutaneous heart valve replacement techniques are invasive and lack repositionability and retractability, posing risks and requiring complex anatomical alignment, while existing delivery systems do not allow for optimal placement or adjustment of prosthetic valves once deployed.
Innovation Solution
The development of a delivery system that uses self-expanding stents with various anchoring structures, allowing for compressibility and expandability, enabling transvascular or retrograde delivery and repositioning of prosthetic heart valves, along with methods for maintaining stent structures in a compressed state during insertion and allowing for expansion and rotational orientation at the implantation site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If percutaneous valve replacement is performed using conventional delivery systems, then the procedure is less invasive, but the valve cannot be repositioned or retrieved once deployed
Solution Approach 1:
The stent is designed with dynamic properties that allow it to transition between expanded and compressed states. The delivery system enables the stent to be expanded for deployment and then re-compressed for retrieval or repositioning, making the otherwise irreversible implantation process reversible. This dynamic capability resolves the contradiction by allowing the valve to maintain repositionability while still being delivered percutaneously.
Solution Approach 2:
The delivery system is designed to maintain the stent in a compressed state during delivery through the vascular system, and only expands it at the target location. This preliminary compression allows the valve to be positioned accurately before deployment, and if needed, can be re-compressed for retrieval. The system prepares the stent for potential repositioning by maintaining compressibility throughout the delivery process.
2Reliability
If the stent is expanded for valve deployment, then the valve can be anchored in place, but the delivery system cannot retrieve or reposition the valve
Solution Approach 1:
The stent's expandable and compressible structure allows it to provide stable anchoring when expanded at the implantation site, yet can be re-compressed by the delivery system for retrieval if needed. This dynamic state transition capability enables both reliable anchoring and potential retrieval, resolving the contradiction between these two opposing requirements.
3Ease of operation
If the prosthetic valve is crimped to fit the catheter, then percutaneous delivery is enabled, but the valve loses its functional shape until deployment
Solution Approach 1:
The stent structure is designed to be dynamically compressible for delivery and expandable to its functional shape at the implantation site. The delivery system maintains the compressed state during transit through the vascular system, then allows expansion to the proper valve configuration upon deployment. This dynamic shape transformation enables both easy percutaneous delivery and proper valve function.
Solution Approach 2:
The prosthetic valve is nested within the expandable stent structure, which itself can be compressed within the delivery catheter. This nested configuration allows the valve to be delivered in a compact form while maintaining its structural integrity, and then expanded to its functional shape at the target location.
4Reliability
If conventional open-heart surgery is used for valve replacement, then the valve can be securely implanted, but the patient faces serious surgical risks
Solution Approach 1:
The invention replaces the mechanical open-heart surgical approach with a percutaneous delivery system. Instead of requiring chest opening and direct surgical manipulation, the valve is delivered through a catheter and deployed using a self-expanding stent mechanism. This substitution maintains reliable implantation through the stent's anchoring capability while eliminating the serious risks associated with open-heart surgery.
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
Enables minimally invasive, repositionable, and retractable prosthetic heart valve delivery, ensuring optimal placement and reducing invasive risks by allowing for full or partial repositioning and maintaining blood flow during deployment, thus improving surgical precision and patient safety.
Implementation Method 1
self-expanding stents with various anchoring structures, allowing for compressibility and expandability
Data Source
AI summary
A delivery system for delivering an implantable stented device to a lumen of a patient, the delivery system including an elongated body having a proximal end and a distal end, a driver mechanism positioned at the proximal end of the elongated body, an elongated threaded rod located axially distal to the driver mechanism, and a sheath including an elongated tubular portion having a hollow interior portion with a first diameter that is sized for compression and retention of the implantable stented device in a compressed configuration for delivery to a body lumen.