Prosthetic Valve Cover Assembly for Faster Sterile Sheath Loading
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Preparing a replacement heart valve and its associated delivery system for transcatheter implantation is complicated, time-consuming, and prone to human error, especially in high-risk patients where surgical valve replacement is not appropriate.
Innovation Solution
A packaging system that securely stores and prepares the prosthetic valve and delivery system, allowing for compact storage and efficient assembly by reducing steps and personnel, featuring a tray with a cavity, valve cover, and engaging surfaces to maintain the valve and system in a compressed state, with optional features like a lock and handle for secure handling and hydration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional separate packaging and preparation methods are used for prosthetic valves and delivery systems, then sterilization and storage are maintained, but the assembly process becomes complicated and time-consuming
Solution Approach 1:
The patent combines the prosthetic valve and delivery system into a single integrated packaging unit where the valve is pre-mounted on the delivery system within a shared sterile environment. This merging eliminates separate assembly steps and reduces preparation time while maintaining sterilization integrity through a unified sealed packaging structure.
Solution Approach 2:
The prosthetic valve is pre-assembled onto the delivery system during manufacturing and sealed in a sterile packaging environment before use. This preliminary action eliminates the need for complex intraoperative assembly steps, reducing preparation time and minimizing the risk of contamination while maintaining reliability.
2Ease of manufacture
If multiple personnel are involved in assembling the replacement heart valve and delivery system, then complex assembly tasks are covered, but the risk of human error increases
Solution Approach 1:
The packaging system is designed to be self-explanatory with built-in guides, alignment features, and intuitive mechanisms that allow a single operator to complete the assembly process without requiring multiple personnel. The system guides the user through the assembly steps, reducing human error while maintaining ease of manufacture.
Solution Approach 2:
The assembly process is segmented into distinct, pre-defined steps with dedicated packaging features for each stage. The packaging includes separate compartments and guided interfaces that break down the complex assembly into manageable segments, reducing cognitive load and error risk while maintaining ease of manufacture.
3Volume of moving object
If the prosthetic valve is stored in a compressed state for compact packaging, then storage efficiency improves, but the valve structure may be compromised
Solution Approach 1:
The packaging system controls the compression parameters (pressure, duration, temperature) to optimize the balance between compact storage and valve structural integrity. The valve is compressed to a specific degree that minimizes packaging volume while remaining within safe structural limits, and this parameter is maintained throughout storage and delivery.
Solution Approach 2:
The packaging includes cushioning elements and controlled compression structures that protect the valve during storage and transport. These cushioning features prevent excessive or uneven compression that could damage the valve structure while maintaining compact packaging size, ensuring the valve remains structurally sound until deployment.
Data Source
AI summary
A valve cover apparatus for use in a medical assembly including a prosthetic valve and a valve delivery apparatus. The valve cover apparatus includes a housing, a chamber disposed within the housing for receiving a prosthetic heart valve in an at least partially expanded state, a tapered surface defining a portion of the chamber, and a lock ring that is axially movable over at least a portion of the housing between a locked position and an unlocked position. The tapered surface is enables loading and/or guiding of the prosthetic heart valve from the chamber of the valve cover apparatus into a delivery sheath of the valve delivery apparatus and transition the prosthetic heart valve to a radially compressed state. The lock ring restricts movement of the valve cover relative to the delivery sheath when in the locked position, and enables movement of the valve cover when in the unlocked position.