Rotatable Retention Socket for Prosthetic Aortic Valve Orientation
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Solution Overview
Problem
Current TAVI devices lack the ability to rotate the prosthetic aortic valve relative to its axis, making it difficult to align the valve commissures with native commissures to avoid obstruction of coronary arteries, which is crucial for future coronary interventions and valve replacement procedures.
Innovation Solution
A rotatable implant retention socket is integrated into the delivery device, allowing independent rotational positioning of the prosthetic valve relative to other parts of the system, enabling optimal alignment of the valve commissures with native commissures by determining the implantation angle through pre-procedural imaging and adjusting the socket's orientation before deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If the delivery device is designed with high axial stiffness to reduce compression and elongation during the procedure, then positional accuracy and control of implant deployment is improved, but the device cannot rotate around its central axis when bent to navigate around the aortic arch
Solution Approach 1:
The delivery device is divided into multiple segments with different rotational capabilities. The inner shaft is designed to be non-rotatable to maintain positional accuracy, while the outer shaft and capsule assembly are designed to be rotatable to enable navigation around the aortic arch. This segmentation allows each component to perform its specific function without compromise.
Solution Approach 2:
A rotatable capsule assembly acts as an intermediary between the non-rotatable inner shaft and the implant. The capsule can rotate around the inner shaft during navigation, allowing the implant to be positioned correctly around the aortic arch while the inner shaft maintains its high axial stiffness and positional accuracy.
2Ease of operation
If the device is designed to navigate around the aortic arch by curving in position, then access to the target site is improved, but rotation of the inner or outer shaft around their central axis becomes impossible
Solution Approach 1:
The device transitions from a static, non-rotatable configuration during navigation to a dynamic, rotatable configuration during deployment. The capsule assembly is designed to be flexible and rotatable when needed for navigation, while the inner shaft maintains its structural integrity and non-rotatable nature for positional accuracy.
3Device complexity
If the socket is made fixed relative to the delivery device axis, then structural simplicity is improved, but alignment of prosthetic valve commissures with native commissures cannot be achieved
Solution Approach 1:
The socket is pre-configured with rotational markings and reference features that allow the operator to rotate it to the correct orientation before implant deployment. This preliminary rotational adjustment ensures that the prosthetic valve commissures will align with the native commissures when the implant is deployed, without requiring complex mechanical alignment mechanisms.
Data Source
AI summary
A retention socket for retaining a prosthetic aortic valve in a delivery device includes a retention recess positioned on an external surface of the retention socket. The retention recess engaging with a paddle or other retention feature of the prosthetic aortic valve. The retention socket is rotatable relative to a longitudinal axis of the delivery device.