Dock Holder Packaging for Sterile Coil Alignment and Protection
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Solution Overview
Problem
Transcatheter heart valves face challenges in appropriately sizing and securing prosthetic valves within varying mitral and tricuspid valve anatomies, leading to inefficiencies and paravalvular leakage, necessitating improved docking systems and delivery systems for secure and effective implantation.
Innovation Solution
A dock holder and packaging system that includes a base, lid, and dock holder configured to securely receive and maintain the dock assembly, utilizing protrusions and helical threads to retain the assembly in a desired orientation, ensuring sterility and preventing damage during storage and shipment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a prosthetic valve is mounted on a flexible catheter and advanced through a blood vessel, then the valve can be implanted less invasively than open heart surgery, but it becomes difficult to appropriately size and secure the valve within varying mitral and tricuspid valve anatomies
Solution Approach 1:
The delivery system is divided into separate functional components: a delivery catheter for minimal access, a docking system for secure anchoring, and a prosthetic valve for replacement. This segmentation allows each component to be optimized independently - the catheter for minimal invasiveness and the docking system for anatomical adaptability.
Solution Approach 2:
A docking system acts as an intermediary component between the delivery catheter and the prosthetic valve. The docking system provides a secure anchor point within the native valve anatomy, enabling stable implantation while accommodating variations in valve size and shape. This intermediary structure resolves the contradiction by bridging the minimal access requirement with the need for secure, adaptable anchoring.
2Reliability
If the surrounding tissue is not strong enough to hold certain types of valves in position, then a docking system is needed to secure the valve, but the docking system requires proper preparation and packaging to maintain functionality
Solution Approach 1:
The docking system components are designed to be integrated and packaged together as a complete assembly. The docking system, including its securing mechanisms and the prosthetic valve, is pre-assembled and packaged in a sterile container with all necessary components. This merging reduces the complexity of separate preparation steps while maintaining reliable valve positioning through the integrated docking mechanism.
3Reliability
If the native valve shape allows for paravalvular leakage around the prosthetic valve, then solutions are needed to reduce leakage, but proper sizing and shaping for many patients remains difficult
Solution Approach 1:
The prosthetic valve and docking system are designed with dynamic adaptability to conform to the native valve anatomy. The docking system can be adjusted and shaped to match the specific geometry of the patient's mitral or tricuspid valve, allowing optimal sealing against the native annulus. This dynamic adaptation capability enables effective prevention of paravalvular leakage while accommodating wide variations in patient anatomy.
Data Source
AI summary
A container configured to receive a dock assembly therein for packaging is disclosed. The container can include: a base defining an engagement surface configured to receive the dock assembly; a lid configured to releasably engage with the base such that at least a portion of the dock assembly is disposed between the base and the lid; and a dock holder affixed to the container and configured to receive a first portion of the dock assembly comprising two or more adjacent coils thereon. The dock holder can comprise a protrusion configured to engage the first portion of the dock assembly and space a second portion of the dock assembly away from the dock holder.