Percutaneous Heart Valve Delivery System for In Situ Fracture
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Solution Overview
Problem
Patients with previously implanted surgical prosthetic valves requiring transcatheter valve-in-valve replacement often experience unfavorable outcomes due to patient-prosthetic mismatch and valvular insufficiency caused by bioprosthetic valve fracture, which can lead to leaflet damage and thrombus formation.
Innovation Solution
A percutaneous heart valve delivery system featuring a first inflatable balloon to fracture a previously implanted prosthetic valve in situ, allowing for the subsequent implantation of a replacement transcatheter valve without withdrawing the delivery system, and optionally using a second balloon for transcatheter valve expansion, with an intravascular ultrasound system for real-time imaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a high-pressure balloon is inflated inside the new transcatheter valve to fracture the old ring, then the bioprosthetic valve fracture is achieved, but severe compression of the new valve's delicate leaflets over its enclosing stents occurs causing leaflet damage and thrombus formation
Solution Approach 1:
The patent performs the bioprosthetic valve fracture using a first inflatable balloon positioned distal to the new transcatheter valve, before the new valve is fully deployed and sealed. This preliminary action allows the fracture to occur without the new valve leaflets being in position to suffer compression damage, thus achieving the fracture while protecting the new valve structure
Solution Approach 2:
The patent separates the fracture function from the valve deployment function by using two distinct balloons: a first inflatable balloon for fracturing the bioprosthetic valve and a second inflatable balloon for expanding the new transcatheter valve. This segmentation allows each function to be performed independently without interfering with the other, preventing leaflet damage while achieving both objectives
2Area of stationary object
If bioprosthetic valve fracture is performed before transcatheter valve implantation using an inflatable balloon, then the valve area is improved, but valvular insufficiency occurs that needs to be immediately addressed
Solution Approach 1:
The patent performs the bioprosthetic valve fracture as a preliminary action before implanting the new transcatheter valve. By fracturing the old valve first, the patent creates adequate space and improves valve area for the new implantation, while the immediate subsequent deployment of the new valve addresses any valvular insufficiency that occurs during the fracture process
Solution Approach 2:
The patent maintains continuous useful action by immediately deploying the new transcatheter valve after fracturing the bioprosthetic valve, without withdrawing the delivery system. This continuous process ensures that any valvular insufficiency is immediately addressed by the new valve deployment, maintaining therapeutic benefit throughout the procedure
3Ease of manufacture
If the delivery system is withdrawn after bioprosthetic valve fracture but before new valve implantation, then the fracture can be performed, but valvular insufficiency occurs and requires additional intervention
Solution Approach 1:
The patent maintains the delivery system in place continuously throughout the entire procedure, from bioprosthetic valve fracture to new transcatheter valve implantation. This continuous presence of the delivery system allows immediate deployment of the new valve to address any valvular insufficiency without requiring system withdrawal and re-introduction, ensuring procedural efficiency and reliability
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
This approach minimizes undesirable regurgitation and leaflet damage, enabling efficient valve replacement while maintaining the integrity of the new transcatheter valve, reducing the risk of thrombus formation and improving hemodynamic results.
Implementation Method 1
a first inflatable balloon positioned at a distal end of the valve delivery catheter, wherein the first inflatable balloon is configured to fracture a previously implanted prosthetic heart valve
Implementation Method 2
an intravascular ultrasound (IVUS) imaging system, wherein an ultrasound transducer of the IVUS imaging system is slidably movable with respect to the first inflatable balloon and the replacement transcatheter valve
Data Source
AI summary
A percutaneous heart valve delivery system including a valve delivery catheter coupled with a first inflatable balloon positioned at a distal end of the valve delivery catheter, wherein the first inflatable balloon is configured to fracture a previously implanted prosthetic heart valve; and a replacement transcatheter heart valve positioned proximal to the first inflatable balloon, wherein the replacement transcatheter heart valve is configured to be implanted subsequently within the previously implanted, fractured prosthetic heart valve, following fracture of the previously implanted heart valve without withdrawal of the percutaneous heart valve delivery system. Also disclosed are methods of implantation of a new heart valve within a previously implanted prosthetic heart valve and methods of valvuloplasty of a native heart valve.