Cardiac Valve Deployment Instrument with Independent Radial Expansion
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Solution Overview
Problem
Current methods for implanting expandable prosthetic cardiac valves face challenges in precise delivery and positioning, particularly in preventing misalignment during expansion, and lack instruments for safe removal.
Innovation Solution
A device with a carrier portion and manipulation portion, featuring independently operable deployment elements and actuators, allows for precise radial and axial positioning and expansion of the valve, enabling accurate placement and potential for removal through a system with micro-adjustment and rotational control, and optional use of balloons for expansion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional surgical techniques are used to implant cardiac valve prostheses, then the valve can be securely implanted, but the surgical operation is highly invasive and complex
Solution Approach 1:
The delivery system is divided into separate functional components: a delivery catheter for navigation, an expandable valve prosthesis with anchoring elements, and a deployment mechanism. This segmentation allows minimally invasive delivery while maintaining secure implantation through specialized components.
Solution Approach 2:
A delivery catheter acts as an intermediary device to transport the valve prosthesis from the access site to the target location. The catheter enables minimally invasive access while the prosthesis maintains secure anchoring, resolving the contradiction between ease of access and implantation security.
2Productivity
If the valve is expanded rapidly to ensure proper positioning, then deployment speed increases, but misalignment during expansion occurs
Solution Approach 1:
The valve prosthesis is pre-assembled with anchoring elements in a compressed state within the delivery catheter. Positioning and alignment are performed while compressed, then rapid expansion occurs once positioning is confirmed, ensuring both speed and precision.
Solution Approach 2:
The deployment process uses dynamic control where the valve transitions from a compressed deliverable state to an expanded functional state. The system allows controlled expansion timing to prevent misalignment while maintaining deployment efficiency.
3Ease of operation
If the valve is delivered retrograde through catheters, then minimally invasive access is achieved, but positioning precision becomes difficult
Solution Approach 1:
The delivery system incorporates feedback mechanisms through radiopaque markers and visual indicators that allow real-time monitoring of valve position during retrograde delivery. This enables precise positioning confirmation while maintaining minimally invasive access through catheters.
4Measurement precision
If the valve is delivered antegrade through the apex, then positioning is easier, but the approach is more complex and less versatile
Solution Approach 1:
The delivery catheter system is designed with universal applicability to accommodate both retrograde and antegrade delivery approaches. The same basic catheter structure can be configured for different access methods, providing positioning ease while reducing overall system complexity through multi-functionality.
Data Source
Figure 1A~1B
Figure 2
Figure 3A~3E
AI summary
An instrument for deploying a cardiac valve prosthesis, including a plurality of radially expandable portions, at an implantation site, includes a plurality of deployment elements each independently operable to obtain the radial expansion of a radially expandable portion of the valve prosthesis. A method for deploying the cardiac valve prosthesis includes advancing the instrument to an implant site and independently actuating the radially expandable portions.