Supra-Annular Heart Valve Delivery for Stable Annulus Alignment

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Solution Overview

Problem

Traditional transcatheter prosthetic heart valves face challenges in delivery and deployment due to size limitations imposed by the patient's vasculature, particularly when using a surgical approach, and the orientation of the valves during deployment can complicate alignment with the native valve annulus.

Innovation Solution

The use of a delivery system with a control device and supra-annular supports to stabilize and actuate the prosthetic valve during deployment, allowing for side-delivery and expansion into the native valve annulus, utilizing a control catheter and connection member to removably couple to the prosthetic valve and advance it in a compressed configuration through a delivery sheath, with supra-annular supports stabilizing the valve relative to the annular plane.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Volume of moving object

If traditional radial compressed delivery method is used, then the delivery catheter diameter can be minimized, but the expanded diameter of the prosthetic valve is limited

Engineering Contradiction:

Improveexpanded diameter of prosthetic valveVSAvoiddelivery catheter size constraints

Core Design Contradiction:

Volume of moving objectVSDevice complexity

Solution Approach 1:

The patent transitions from traditional radial compression (compressing valve diameter) to axial compression (compressing valve length), enabling the valve to be delivered through catheters of comparable size while achieving larger expanded diameters. The valve is compressed along its longitudinal axis rather than radially, fundamentally changing the compression dimension.

Inventive Principle:

Principle #17Another dimension (Dimensionality change)

Solution Approach 2:

The patent changes the compression parameters from radial to axial, allowing the prosthetic valve to be compressed in a different direction. This parameter change enables larger valve diameters to be achieved while maintaining compatibility with standard delivery catheter sizes through the altered compression approach.

Inventive Principle:

Principle #35Parameter changes

2Ease of operation

If traditional radial compressed valves are used, then the delivery process is simplified, but alignment with the native valve annulus becomes complicated

Engineering Contradiction:

Improvevalve alignment with native annulusVSAvoiddeployment orientation requirements

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

Instead of delivering the valve in a radial orientation and then rotating it for alignment, the patent inverts the approach by delivering the valve in an axial orientation with the central annular axis substantially perpendicular to the delivery catheter's longitudinal axis. This inverted delivery orientation simplifies alignment with the native valve annulus.

Inventive Principle:

Principle #13The other way round (Inversion)

3Volume of moving object

If side delivery is used to increase expanded diameter, then larger valves can be delivered, but stability during deployment is reduced

Engineering Contradiction:

Improveexpanded diameter of prosthetic valveVSAvoidvalve stability during deployment

Core Design Contradiction:

Volume of moving objectVSStability of the object's composition

Solution Approach 1:

The patent introduces a delivery system with a control device and supra-annular supports that act as intermediaries to stabilize the prosthetic valve during deployment. These supports maintain the valve's orientation and position, providing the necessary stability while enabling side delivery of larger valves.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The delivery system performs multiple functions: it delivers the compressed valve, maintains stability during deployment, ensures proper orientation, and facilitates alignment with the native annulus. This multi-functional system addresses both the need for larger valve diameters and the requirement for deployment stability.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS12588993B2Devices and methods for delivering a prosthetic heart valve using supra-annular support

Publication Date: 2026.03.31 VDYNE INC

AI summary

A delivery system includes a delivery sheath with a control device and at least one supra-annular support being movable through a lumen of the delivery sheath. The control device includes a connection member coupled to a distal end of a control catheter. The connection member is configured to removably couple to the prosthetic valve at a proximal position along a supra-annular portion of the prosthetic valve. The control device is operable to advance the prosthetic valve in a compressed configuration through the delivery sheath and to at least partially deploy the prosthetic valve in an expanded configuration into a native valve annulus. The supra-annular support(s) is/are removably coupleable at one or more positions along the supra-annular portion of the prosthetic valve and is/are configured to stabilize or actuate at least a portion of the prosthetic valve relative to an annular plane of a native heart valve during deployment.