Expandable Bumper for Prosthetic Valve Delivery Capsule Transition
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Solution Overview
Problem
Stented prosthetic heart valves often have a rough outer surface that can cause damage during delivery and can snag on delivery devices during loading and recapture procedures, leading to complications in minimally invasive heart valve implantation.
Innovation Solution
Incorporating a bumper with a distal end that expands to provide a ramped surface for smooth transition and collapses when fully advanced, allowing the capsule to cover the prosthetic valve without increasing the delivery device's profile, thereby preventing snagging and reducing capsule length for easier navigation through anatomical structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a protective sheath or capsule is used to cover the rough outer surface of the prosthetic valve, then damage to the patient during delivery is prevented, but the capsule can snag on the proximal end of the prosthetic valve during loading or recapture
Solution Approach 1:
The bumper acts as an intermediary element between the capsule and the prosthetic valve. It provides a smooth transition surface that allows the capsule to pass over the prosthetic valve without snagging, while still protecting the patient from the rough outer surface of the valve during delivery
Solution Approach 2:
The bumper utilizes radial expansion to create a ramped surface that extends outward from the proximal end of the prosthetic valve. This dimensional change creates a gradual slope that facilitates smooth capsule passage, transforming a problematic sharp edge into a beneficial guiding surface
2Object-affected harmful factors
If the capsule is advanced over the prosthetic valve during loading, then the prosthetic valve is protected, but the capsule length must be increased which makes navigation through anatomy more difficult
Solution Approach 1:
The bumper is pre-positioned at the proximal end of the prosthetic valve before capsule advancement. This preliminary positioning allows the capsule to be shorter since the bumper is already in place to guide and protect the valve, eliminating the need for the capsule to accommodate the full length required for protection
3Ease of operation
If the distal end of the bumper is expanded to provide a ramped surface, then smooth transition for capsule is achieved, but the profile of the delivery device increases
Solution Approach 1:
The bumper transitions from a compressed low-profile state during delivery to an expanded state with the ramped surface during loading and recapture operations. This dynamic transformation allows the bumper to provide its smooth transition function only when needed, while maintaining a compact profile during the delivery phase
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The bumper ensures smooth loading and recapture of the prosthetic valve, reduces capsule length for easier navigation through complex anatomy, and allows for a lower profile and increased flexibility during delivery, minimizing damage and procedural challenges.
Implementation Method 1
The bumper has a distal end and a proximal end. In a first position, the distal end of the bumper is unrestrained by the delivery device and therefore has a larger, expanded outer diameter as compared to the proximal end due to a natural bias.
Implementation Method 2
When the capsule is fully advanced over the prosthetic heart valve, the outer sheath is in a position to completely cover the bumper, thus collapsing the distal end of the bumper against its outward bias so that the bumper is generally shaped like a cylinder.
Data Source
AI summary
Delivery devices for delivery of a stented prosthetic heart valve. Various delivery devices include an outer sheath assembly including an outer sheath connected to a capsule that is advanced proximally to retain the prosthetic valve, which is secured over an inner shaft assembly of the delivery device. The delivery device further includes a bumper to provide a smooth transition of the capsule over the prosthetic valve during loading and recapture procedures. The bumper is expandable from a first position to a second position in which a distal end of the bumper is expanded to increase its diameter. The bumper can be biased in the second, expanded position so that the bumper automatically transitions to the expanded position upon retraction of the outer sheath.