Cardiac Valve Positioning Wire with Expandable Anchor
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Solution Overview
Problem
There is a need for precise delivery and implantation instruments capable of positioning expandable prosthetic cardiac valves at the correct location within the valve annulus while ensuring proper alignment with the Valsalva sinuses, and for instruments that can control the expansion of the valve to prevent misalignment during implantation.
Innovation Solution
A device comprising a wire element with an expandable element that secures the valve in place without occluding blood flow, allowing for precise axial and radial positioning of the valve prosthesis, using a guide wire and expandable elements that can expand symmetrically around the wire to anchor the valve at the desired location within the vessel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If an expandable prosthetic valve is delivered through a catheter using percutaneous implantation, then minimally invasive surgical techniques are achieved, but the prosthesis must be positioned precisely at the valve annulus while maintaining blood flow
Solution Approach 1:
A delivery catheter serves as an intermediary device that guides the expandable prosthetic valve to the precise location of the valve annulus. The catheter system includes positioning elements that enable accurate placement while maintaining the minimally invasive percutaneous approach, thus resolving the contradiction between ease of operation and positioning precision.
Solution Approach 2:
The delivery catheter is advanced to the target position before valve expansion occurs. Positioning markers and guidance systems are used to pre-establish the correct axial and radial position, ensuring that when the valve is deployed, it lands precisely at the valve annulus with proper alignment, thereby achieving both minimally invasive delivery and precise positioning.
2Strength
If the prosthesis is expanded to secure it in place, then anchoring strength is improved, but misalignment during expansion may occur
Solution Approach 1:
The delivery catheter incorporates dynamic positioning capabilities with adjustable expansion elements that can be controlled during the expansion process. This allows the valve to be expanded in a controlled manner while maintaining proper alignment, preventing misalignment during expansion while achieving sufficient anchoring strength.
Solution Approach 2:
Positioning markers on the catheter and imaging guidance systems provide real-time feedback during the expansion process. This enables continuous monitoring and adjustment to ensure the valve expands at the correct location and orientation, preventing misalignment while maintaining anchoring strength.
3Measurement precision
If a wire element is used to facilitate advancement, then positioning accuracy is improved, but the wire may occlude blood flow
Solution Approach 1:
The wire element is designed as a thin, flexible component that can be covered or protected by a catheter sheath. This thin-film approach maintains the positioning accuracy benefits of a wire element while minimizing blood flow occlusion. The wire is visible through or covered by a transparent or radiopaque sheath that allows blood flow while maintaining guidance functionality.
Solution Approach 2:
The catheter sheath acts as an intermediary that covers the wire element during blood flow contact. This protects the wire from directly occluding blood flow while still allowing the wire to provide positioning guidance. The sheath material is selected to be biocompatible and to not interfere with blood flow dynamics.
Data Source
AI summary
An instrument for positioning a cardiac valve prosthesis in a vessel includes a wire element to slidingly guide the valve prosthesis towards an implantation site and an expandable element coupled to the wire element. The expandable element is expandable in the vessel to position the wire element in association with the implantation site. A method for positioning a cardiac valve prosthesis includes securing a delivery instrument at an appropriate location at the implantation site and delivering the valve prosthesis to the implantation site using the delivery instrument.