Intravascular Lithoplasty Balloon for Consistent Pressure Output

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Solution Overview

Problem

Existing intravascular lithoplasty (IVL) devices face challenges such as increased risk of trauma during translation, complex construction, and inconsistent pressure output variability, which can lead to balloon instability and unpredictable outcomes.

Innovation Solution

The IVL system incorporates a catheter design with a flexible tip and kink-resistant shaft, featuring a reduced crossing profile and improved pushability. The system includes electrodes within a fluid-filled member, generating pressure waves for effective lesion treatment while maintaining consistent pressure output.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing IVL devices are used, then pressure waves can be generated for lesion treatment, but pressure output variability is inconsistent leading to balloon instability and unpredictable outcomes

Engineering Contradiction:
Improvepressure output consistencyVSAvoidballoon stability control
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system incorporates pressure sensors that continuously monitor the pressure within the balloon and provide feedback to the control system. The control system adjusts the voltage pulse parameters in real-time based on this feedback to maintain consistent pressure output, thereby resolving the contradiction between reliability and device complexity.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent implements dynamic adjustment of electrical parameters (voltage, current, pulse duration) based on monitored pressure conditions. By changing these parameters adaptively, the system maintains consistent pressure output despite variations in lesion characteristics, improving reliability without requiring overly complex mechanical structures.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If a standard catheter design is used, then the device can be manufactured with simpler construction, but the risk of trauma during translation through vessels increases

Engineering Contradiction:
Improvevessel trauma riskVSAvoidcatheter construction
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The catheter incorporates a flexible tip section with different mechanical properties than the shaft. The tip is designed with increased flexibility and reduced stiffness to navigate vessel bends and reduce trauma risk, while the shaft maintains sufficient rigidity for stable positioning and pressure delivery. This local differentiation resolves the contradiction between reducing trauma and maintaining structural integrity.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The catheter design includes a flexible tip that can dynamically adapt to vessel geometry during translation. The flexible section allows the catheter to conform to tortuous vessel paths, reducing mechanical trauma, while the overall catheter structure maintains enough stiffness to deliver effective pressure waves when positioned at the lesion site.

Inventive Principle:
Principle #15Dynamics

3Power

If electrodes are positioned within the balloon, then pressure waves can be generated effectively, but the device complexity and manufacturing difficulty increase

Engineering Contradiction:
Improvepressure wave generation efficiencyVSAvoidelectrode assembly integration
Core Design Contradiction:
PowerVSEase of manufacture

Solution Approach 1:

The electrodes are integrated directly into the balloon structure, with conductive elements embedded in the balloon wall or mounted on the inner surface. This merging of the electrode assembly with the balloon eliminates the need for separate electrode housings and complex wiring arrangements, reducing manufacturing complexity while maintaining effective pressure wave generation.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The system uses the pressurized fluid within the balloon as a medium to transmit electrical energy from the electrodes to the lesion. The fluid-filled environment enhances the efficiency of pressure wave generation by providing a conductive medium and allowing for more effective coupling of the electrical energy to the vessel wall, thereby improving power efficiency while simplifying the overall design.

Inventive Principle:
Principle #29Pneumatics and hydraulics

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 improved IVL system reduces the risk of trauma and complexity, provides enhanced pushability and kink resistance, and achieves tighter control over pressure output, ensuring more stable and predictable treatment outcomes.

Implementation Method 1

A voltage pulse generator may be in operative communication with a controller and in operative communication with pairs of spaced-apart electrodes, wherein the voltage pulse generator is configured to apply voltage to the spaced-apart electrodes to generate electrical arcs

Methodology Applied
Scientific EffectElectrical arc: Electric Arc

Implementation Method 2

creating pressure waves

Methodology Applied
Scientific EffectPressure wave generation: Shock Wave

Data Source

PatentUS20250288309A1Intravascular lithoplasty system with improved durability, efficiency and pressure output variability
Publication Date: 2025.09.18 CARDIOVASCULAR SYSTEMS INC
  • US20250288309A1 patent drawing
  • US20250288309A1 patent drawing
  • US20250288309A1 patent drawing

AI summary

Various embodiments of the systems, methods and devices are provided for breaking up calcified lesions in an anatomical conduit wherein exemplary systems generate an electrical arc between two spaced-apart electrodes disposed within a fluid-filled balloon.