Multiple-Balloon Shock Wave Valvuloplasty for Calcified Valve Cusps
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Solution Overview
Problem
Aortic valve stenosis caused by calcified plaques on the leaflets and annulus leads to narrowing, interfering with efficient blood flow, and existing methods for treating this condition are inadequate.
Innovation Solution
The application of shock waves using devices with balloons and shock wave sources, which are designed to fit within the concave portions of valve cusps, to crack and break calcium deposits, thereby softening and loosening the valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple balloons with shock wave sources are used to treat calcified valve cusps, then the effectiveness of calcium deposit removal is improved, but the device complexity increases
Solution Approach 1:
The device divides the treatment function into multiple independent balloons, each equipped with its own shock wave source. Each balloon can be independently positioned within a specific valve cusp and activated to treat calcium deposits in that cusp, allowing segmented treatment of different valve regions simultaneously or sequentially.
Solution Approach 2:
Multiple balloons are nested within a single delivery catheter system, allowing them to be delivered through a single access point and deployed sequentially or simultaneously within different valve cusps. The balloons can be collapsed within the catheter for delivery and then expanded at the target site.
2Measurement precision
If balloons are inflated to fit within concave portions of valve cusps, then the precision of shock wave delivery is improved, but the risk of obstructing coronary artery openings increases
Solution Approach 1:
The balloon is designed with non-uniform thickness, having a thinner portion specifically positioned to align with the coronary artery opening. This localized thinning allows the balloon to maintain contact with the valve cusp for precise shock wave delivery while creating a window that permits coronary artery blood flow to pass through without obstruction.
Solution Approach 2:
The thin portion of the balloon acts as an intermediary structure that mediates between the need for close contact with the valve cusp (for precise shock wave delivery) and the need to allow coronary artery flow. The thin section transmits shock waves effectively while permitting blood flow through the coronary artery opening.
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 method allows the valve to regain its normal function by cracking and removing calcium deposits, potentially improving the outcome of subsequent transcatheter aortic valve implantation procedures and reducing the risk of cardiac ischemia during the procedure.
Implementation Method 1
The mechanical force of the shock waves may act to crack and/or break calcium deposits located within the concave portion of the valve cusp
Implementation Method 2
The mechanical force of the shock waves may act to crack and/or break calcium deposits
Data Source
AI summary
Described herein are shock wave devices and methods for the treatment of calcified heart valves. One variation of a shock wave device includes three balloons that are each sized and shaped to fit within a concave portion of a valve cusp when inflated with a liquid and a shock wave source within each of the three balloons. Each balloon is separately and/or independently inflatable, and each shock wave source is separately and/or independently controllable. Methods of treating calcified heart valves using a shock wave device can include advancing a shock wave device having one or more balloons and a shock wave source in each of the balloons to contact a heart valve, inflating the one or more balloons with a liquid such that the balloon is seated within a concave portion of a valve cusp, and activating the shock wave source.