Hydraulic Prosthetic Valve Delivery Capsule
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Mitral valve replacement is challenging due to the non-circular, D-shaped or kidney-like geometry of the mitral valve annulus, leading to improper positioning and leakage of prosthetic valves, and uncontrolled deployment of self-expanding valves causing axial jumping and migration.
Innovation Solution
A hydraulic delivery system using a catheter with a delivery capsule that can be hydraulically actuated to deploy a prosthetic heart valve device, minimizing uncontrolled movement and ensuring proper positioning by using a biasing device to counteract deployment forces and a positioner to align the valve with the native valve anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If self-expanding prosthetic mitral valves are used, then deployment is simplified, but uncontrolled axial jumping and self-ejection occur resulting in improper positioning
Solution Approach 1:
A delivery capsule acts as an intermediary device that contains the self-expanding prosthetic valve during delivery and controls its deployment. The capsule provides a controlled environment for expansion, preventing uncontrolled axial jumping while maintaining the simplicity of self-expanding mechanism. The delivery system includes a catheter that positions the capsule at the target site before controlled release.
Solution Approach 2:
The prosthetic valve is pre-loaded into the delivery capsule in a compressed state before delivery. The capsule is positioned at the target mitral valve site beforehand, and only then is the expansion triggered. This preliminary positioning and preparation prevents uncontrolled deployment and ensures accurate placement.
2Ease of operation
If percutaneous catheters are used for delivery, then invasiveness is reduced, but control over valve positioning is diminished
Solution Approach 1:
The delivery capsule serves as an intermediary between the percutaneous catheter and the prosthetic valve. It maintains minimal invasiveness through percutaneous access while providing enhanced control over valve positioning and deployment. The capsule can be precisely positioned using the catheter and then controlled to deploy the valve at the optimal location.
Solution Approach 2:
The delivery system incorporates imaging guidance and positioning feedback mechanisms that allow real-time monitoring of catheter and capsule position. This feedback enables the operator to adjust the delivery system to achieve precise valve placement while maintaining percutaneous access.
3Manufacturing precision
If the mitral valve annulus geometry is accommodated, then proper valve seating is achieved, but deployment control becomes more difficult
Solution Approach 1:
The delivery capsule is designed with dynamic control capabilities that allow adjustment of deployment forces and timing. The system can adapt to the non-circular D-shaped or kidney-like geometry of the mitral valve annulus by modulating the expansion sequence and applying forces in multiple directions, achieving proper seating without excessive complexity.
Solution Approach 2:
The deployment process is segmented into controlled stages: initial positioning of the capsule, gradual expansion of the prosthetic valve, and final seating adjustment. This segmented approach allows the system to accommodate complex annulus geometry while maintaining manageable deployment control through sequential actions.
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 system enables controlled deployment and positioning of prosthetic valves, reducing leakage and migration, and ensuring accurate anchoring within the mitral valve annulus, thereby improving the efficacy of mitral valve replacement procedures.
Implementation Method 1
The distal sheath is hydraulically driven to move from a closed position to an open position
Data Source
Figure 1~1A
Figure 1A-1
Figure 1B~1C
AI summary
Systems, apparatuses, and methods for treating native heart valves are disclosed herein. A system (2000) for delivering a prosthetic device into a heart of a patient includes an elongated catheter body (2014) and a delivery capsule (2012). The delivery capsule can be hydraulically driven to deploy at least a portion of a prosthetic heart valve device. The delivery capsule can release the prosthetic heart valve device at a desired treatment site in a patient.