Pre-Loaded Heart Valve Delivery Assembly for Easier Implant Loading
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Solution Overview
Problem
There is a need for alternative medical devices and methods for manufacturing and using medical devices, particularly for implanting stents and heart valves, to improve efficiency and ease of use.
Innovation Solution
A replacement heart valve system comprising an implant delivery subassembly with a first elongate shaft, a stent holder, and a distal sheath configured to constrain the heart valve implant in a radially collapsed configuration, which can be pre-loaded and coupled to an implant delivery system, allowing for easy loading and deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the heart valve implant is loaded into the delivery system in the conventional manner, then the implant can be delivered, but the loading process is complex and time-consuming
Solution Approach 1:
The implant is pre-loaded into the delivery system in a collapsed state before sterilization and packaging. The distal sheath is pre-positioned over the implant, and the entire assembly is sterilized together as one unit. This preliminary action eliminates the complex and time-consuming loading process during the procedure, as the system is already prepared and simply needs to be deployed.
Solution Approach 2:
The patent combines multiple components (implant, distal sheath, delivery system) into a single pre-loaded assembly that is sterilized and packaged together. This merging of components and processes simplifies the overall system preparation and eliminates separate loading steps during the procedure.
2Reliability
If the implant and delivery system are sterilized separately, then sterilization can be achieved, but the process is complex and requires multiple steps
Solution Approach 1:
The implant, distal sheath, and delivery system are combined into a single assembly that undergoes sterilization as one unit. This merging eliminates the need for multiple separate sterilization steps and reduces the complexity of the sterilization process while maintaining reliability through validated sterilization cycles.
3Length of moving object
If the implant is constrained in a radially collapsed configuration during delivery, then the implant can be delivered through narrow access, but the delivery system must maintain precise constraint
Solution Approach 1:
The distal sheath is designed as a flexible tubular structure that can constrain the implant in a radially collapsed configuration while allowing axial movement. The sheath's flexibility enables it to maintain constraint during delivery through narrow access while accommodating the implant's position and the delivery system's movements.
Solution Approach 2:
The implant is nested within the distal sheath in a collapsed state, allowing the entire assembly to be delivered through narrow access. The nested configuration maintains constraint stability while enabling delivery through small incisions or catheter pathways.
Data Source
AI summary
A replacement heart valve system includes an implant delivery subassembly couplable to an implant delivery system. The subassembly includes a first elongate shaft and a stent holder fixedly attached at a distal end of the first elongate shaft, a replacement heart valve implant, and a distal sheath disposed over a distal portion of the implant with a proximal portion of the implant disposed outside of the distal sheath in a pre-loaded configuration. The subassembly is initially physically separate from the delivery system in the pre-loaded configuration. A method of loading the implant into the replacement heart valve system includes positioning the subassembly adjacent to the delivery system, coupling the subassembly to the delivery system in the pre-loaded configuration, and thereafter shifting a proximal sheath of the delivery system over the proximal portion of the implant.