Balloon-Expanded Prosthetic Heart Valve for Uniform Deployment
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Solution Overview
Problem
Conventional prosthetic heart valves face issues with non-uniform expansion, obstruction of the left ventricular outflow tract (LVOT), and induction of left bundle branch block (LBBB) during deployment, necessitating the use of external pacing devices due to improper fitment and design integrity.
Innovation Solution
A prosthetic heart valve assembly with a delivery catheter that includes a balloon, outer and inner shafts, support tube, and stoppers, designed to mimic native heart valve anatomy, ensuring precise positioning and uniform expansion without affecting nearby structures, eliminating the need for external pacing devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Area of stationary object
If conventional prosthetic heart valves are deployed with large diameters, then the valve can cover the target location, but non-uniform expansion occurs and nearby structures are affected
Solution Approach 1:
The delivery catheter incorporates a balloon with non-uniform circumference (different at proximal, middle, and distal portions) to provide localized expansion forces. This allows the valve to expand uniformly across different sections, compensating for variations in valve structure and ensuring even radial force distribution throughout the deployment process.
Solution Approach 2:
The invention changes the physical parameter of the balloon from uniform to non-uniform circumference. This parameter modification enables the balloon to exert differentiated expansion forces at different locations, thereby achieving uniform valve expansion and preventing the non-uniform expansion problems associated with conventional large-diameter valves.
2Ease of operation
If conventional delivery catheters are used, then the deployment process can be completed, but precise positioning and fitment of the valve are compromised
Solution Approach 1:
The delivery catheter is designed with a pre-configured non-uniform balloon and support structures that are prepared before deployment. This preliminary configuration ensures that when the valve is deployed, the positioning and expansion forces are already optimized, enabling precise fitment without requiring complex adjustments during the procedure.
3Ease of operation
If conventional stoppers with slots are used, then the crimped valve can be held, but the valve loses exact positioning and linearity
Solution Approach 1:
The invention removes the slot feature from the stopper design. By eliminating the slots that cause positioning loss and linearity degradation, the stopper can maintain the valve's exact positioning and linear configuration during crimping and deployment without the harmful effects introduced by conventional slot designs.
4Ease of operation
If high push force is applied during deployment, then the valve can be advanced, but the center of gravity and flexibility are affected
Solution Approach 1:
The delivery catheter acts as an intermediary device that transmits deployment forces uniformly to the valve through its structured design including the non-uniform balloon and support tube. This intermediary mechanism distributes the push force evenly, preventing localized stress concentrations that would otherwise affect the valve's center of gravity and flexibility.
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 assembly allows for accurate deployment, reducing the likelihood of complications such as valve embolization and coronary occlusion, and significantly lowers the requirement for temporary or permanent pacemakers post-implantation.
Implementation Method 1
The valve mounted on the balloon is inflated by providing an inflation fluid(s) inside the balloon and expanding the said valve at the target location
Data Source
Figure 1
Figure 1a
Figure 1b
AI summary
A prosthetic heart valve assembly is disclosed. The said assembly includes a prosthetic heart valve (10). The said valve (10) is mounted over a balloon (5) for deployment at a target location. The dimensions of the said valve (10) mimic the anatomy of a native heart valve. The delivery catheter (100) is used for deployment of the prosthetic heart valve (10). The delivery catheter (100) includes a handle (11), a multi-layered outer shaft (1) and/or an inner shaft (3) including an inner second end (3b). A support tube (7) is disposed on top of the inner second end (3b) and includes one or more holes (7a) for passing an inflation fluid and is provided with the balloon (5) on its outer surface. One or stoppers (9) are provided on the support tube (7) and within the balloon (5) and include a first portion (C) and a second portion (D).