Prosthetic Heart Valve Delivery Capsule for Reposition and Retrieval
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Solution Overview
Problem
Conventional delivery systems for prosthetic heart valves often cause trauma to the body during deployment and lack the ability to adjust or retrieve the implant post-deployment, particularly for the tricuspid valve, which is associated with higher mortality rates and requires a less invasive approach.
Innovation Solution
A delivery system featuring a shaft portion with steering and pull wires, a capsule portion with an expandable frame, and a handle for precise control and adjustment of the prosthetic heart valve's position, allowing for deployment, repositioning, and retrieval without damaging native tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional delivery systems are used to deploy prosthetic heart valves, then the implant can be delivered to the target location, but the system cannot adjust the position of the implant after deployment or retrieve it if needed
Solution Approach 1:
The delivery system employs a dynamic retention mechanism where the capsule can transition from a secured state during delivery to a released state after implantation. The system allows for reversible engagement, enabling the operator to adjust the implant position or retrieve it if necessary, while maintaining secure attachment during the critical delivery phase.
Solution Approach 2:
The delivery capsule is designed to be temporarily retained with the prosthetic heart valve during delivery and then discarded (released) after successful implantation. The system allows for the possibility of recapturing the implant if positioning adjustments are needed, effectively enabling recovery of the implant before final deployment.
2Stability of the object's composition
If the prosthetic heart valve is securely attached to the delivery system for transport, then the implant remains stable during delivery, but the attachment mechanism prevents post-deployment adjustment or retrieval
Solution Approach 1:
The attachment mechanism transitions from a stable, secured state during delivery to a releasable state after implantation. The capsule and engagement features are designed to maintain firm attachment during transport while allowing controlled release or adjustment afterward, providing both stability and adaptability at different stages.
Solution Approach 2:
The delivery system pre-secures the prosthetic heart valve in a stable configuration during delivery, then performs a preliminary assessment after implantation before final release. This allows the operator to verify proper positioning and make adjustments if needed before completely disengaging the implant.
3Adaptability or versatility
If the delivery system uses a complex structure to enable adjustment and retrieval capabilities, then the implant can be positioned and retrieved if needed, but the device complexity increases
Solution Approach 1:
The delivery capsule serves multiple functions: it secures the implant during delivery, positions the implant at the target location, enables post-deployment adjustment, and allows retrieval if necessary. By making the capsule multi-functional, the system achieves high adaptability without requiring separate dedicated components for each function.
Solution Approach 2:
The delivery system combines the retention, positioning, and retrieval control features into a single integrated capsule structure. The engagement features, pull wires, and release mechanisms are merged into one cohesive unit that simplifies the overall system while providing comprehensive control over the implant lifecycle.
4Adaptability or versatility
If the delivery system allows for implant retrieval capability, then the implant can be removed if needed, but the ability to minimize trauma during delivery is compromised
Solution Approach 1:
The delivery capsule utilizes a flexible, low-profile design that can navigate through blood vessels with minimal trauma. The capsule material and structure are designed to be compliant with the vascular anatomy, reducing mechanical injury while maintaining the ability to secure and retrieve the implant if needed.
Data Source
AI summary
Disclosed herein are delivery systems and methods for delivering a prosthetic heart valve to a native heart valve of a heart. An exemplary delivery system may include a shaft portion having at least one shaft, at least one steering wire, and at least one pull wire. The system may further include a handle portion coupled to a proximal end of the shaft portion and a capsule portion coupled to a distal end of the shaft portion. The capsule portion may be configured to house the prosthetic heart valve. At least one portion of the delivery system may be configured to be engaged with the prosthetic heart valve when the prosthetic heart valve is implanted in the native heart valve of the heart.