Heart Valve Packaging Assembly for Pre-Tensioned Delivery Attachment
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Solution Overview
Problem
The process of packaging and preparing a replacement heart valve for implantation is cumbersome and prone to human error, requiring skilled practitioners to rinse and attach the valve to a delivery system, which can lead to damage and inefficiencies.
Innovation Solution
A packaging assembly comprising a valve support and a retention mechanism that securely holds and tensions the replacement heart valve, allowing for pre-tensioning and protection during shipment, enabling efficient attachment to a delivery system while minimizing handling and reducing the risk of damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a practitioner manually rinses and attaches the replacement heart valve to the delivery system, then the valve can be prepared for implantation, but the process requires skill and time and can lead to human error
Solution Approach 1:
The packaging assembly is pre-configured with the retention mechanism, sutures, and valve positioning arrangements before shipment. The sutures are pre-attached to the valve and the retention mechanism is pre-assembled, allowing the practitioner to simply activate the pre-prepared system rather than performing complex assembly steps during preparation.
Solution Approach 2:
The packaging assembly is designed to be self-explanatory and self-operating. The retention mechanism automatically engages with the valve when the packaging is opened, and the sutures are pre-positioned to automatically align with the valve features, reducing the need for practitioner skill and judgment during preparation.
2Strength
If the replacement heart valve is held stationary in liquid-filled jars during transport, then damage is prevented, but manual handling and rinsing are required prior to implantation
Solution Approach 1:
The packaging assembly merges the protective packaging function with the preparation and attachment functions into a single integrated system. The retention mechanism serves both to protect the valve during transport and to facilitate easy attachment to the delivery system, eliminating the need for separate handling and rinsing steps.
Solution Approach 2:
The packaging assembly performs multiple functions: it protects the valve during transport, maintains valve positioning, facilitates rinsing, enables attachment to the delivery system, and provides a interface for the practitioner. This multi-functional design eliminates the need for separate tools and steps for each operation.
3Reliability
If the retention mechanism includes multiple sutures and locking features, then secure valve holding is achieved, but device complexity increases
Solution Approach 1:
The retention mechanism is divided into separate functional modules: sutures for attachment, locking tabs for positional fixation, and a pin for central alignment. Each component is simple in design but together they provide robust valve securing. The segmentation allows each component to be optimized independently while maintaining overall simplicity.
Data Source
Figure 1A~1B
Figure 2
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AI summary
A system for heart valve repair includes a packaging assembly (130) for storing the replacement heart valve. The packaging assembly (130) includes a valve support (160) having a base for holding the replacement heart valve, a ring (149) positioned within the valve support (160) and configured to fit around a circumference of the replacement heart valve, and a retention mechanism (180). The retention mechanism (188) includes a cap (186) and plurality of sutures (190) configured to be attached to the cap (186) and to the replacement heart valve. The packaging assembly (130) having a locked configuration in which the ring (149) and the valve support (160) are locked together and the sutures (190) tension the replacement heart valve. The packaging assembly (160) is designed to hold and transport a replacement heart valve and fits within a shipment jar.