Intravascular Lithotripsy Balloon Durability via Controlled Voltage Pulses
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Solution Overview
Problem
Existing intravascular lithotripsy (IVL) devices face challenges with declining pressure profiles, unpredictable pressure outputs, and balloon instability due to erosion from electrical arcs, leading to potential damage and reduced durability.
Innovation Solution
The implementation of controlled energy delivery and pressure wave generation through adjustable voltage pulses, using electrodes submerged in a fluid-filled member, with a processor-controlled system to manage spark gaps and maintain consistent pressure outputs, enhancing balloon durability and treatment efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Power
If traditional balloon angioplasty systems are used to apply high pressure (10-15 atm) to treat calcified lesions, then the occlusion yields and blood vessel is opened, but the balloon and conduit wall tissue suffer damage or dissection due to high stress and strain rate
Solution Approach 1:
The patent applies periodic voltage pulses to electrode pairs within the balloon to generate repeated pressure waves. This periodic action allows the balloon to deliver therapeutic pressure in controlled bursts rather than continuous high pressure, reducing cumulative stress on the balloon material while maintaining effective treatment pressure. The pulse-based delivery mechanism extends balloon lifespan by preventing sustained high-stress conditions.
Solution Approach 2:
The patent replaces traditional mechanical balloon expansion with electrical pulse-driven pressure wave generation. Instead of relying on mechanical inflation to high pressures that cause balloon stress and tissue damage, the system uses electrical energy to create acoustic pressure waves that fracture calcified lesions. This substitution eliminates the need for sustained high mechanical pressure, thereby protecting both balloon durability and preventing conduit dissection.
2Productivity
If intravascular lithotripsy devices deliver multiple voltage pulses to treat calcified lesions, then treatment efficacy improves, but pressure output declines with each pulse due to erosion from electrical arcs
Solution Approach 1:
The patent dynamically adjusts voltage pulse parameters (amplitude, duration, frequency) based on real-time feedback from pressure sensors and impedance measurements. This parameter adaptation compensates for electrode erosion and fluid composition changes during prolonged use, maintaining consistent pressure wave generation across hundreds of pulses. The system monitors pressure output and modifies electrical parameters to ensure stable therapeutic effect throughout the procedure.
Solution Approach 2:
The patent incorporates feedback mechanisms where pressure sensors and impedance detectors monitor the state of the fluid and electrode performance during each pulse. This feedback information is used to adjust subsequent voltage pulses, compensating for wear and maintaining optimal pressure output. The closed-loop control system ensures consistent treatment efficacy even after extensive use, enabling up to 500 effective pulses per catheter.
3Reliability
If electrode pairs are submerged in conductive fluid within the balloon to generate pressure waves, then IVL therapy is effective, but unpredictable pressure outputs and balloon instability occur
Solution Approach 1:
The patent introduces an intermediary control system that includes pressure sensors, impedance detectors, and a controller that mediates between the voltage pulse generator and the electrode pairs. This intermediary layer monitors fluid properties, electrode performance, and pressure wave generation in real-time, making adjustments to maintain stable balloon operation and consistent pressure output. The control system compensates for variations in fluid conductivity and electrode erosion, ensuring predictable therapeutic delivery.
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 achieves consistent and controlled pressure outputs, increasing the number of effective pulses per catheter to up to 500, reducing strain on the balloon, and improving the efficiency and safety of IVL procedures.
Implementation Method 1
a voltage pulse generator in operative communication with one or more pairs of electrodes mounted on a catheter and within an inflatable balloon
Implementation Method 2
create flow and pressure waves
Data Source
AI summary
Various embodiments of the systems, methods, and devices are provided for controlled operation of IVL for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing electrical energy to generate an electrical arc between a set of spaced-apart electrodes disposed within a fluid-filled balloon, creating a determined pressure output over several voltage pulses.