Lithoplasty Balloon Arc Channeling for Calcified Lesion Shock Waves
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Solution Overview
Problem
Existing angioplasty systems face challenges in effectively treating calcified lesions due to the limited axial coverage of shock waves generated by closely spaced electrodes, which can cause damage to blood vessels and require multiple electrode pairs, and there is a need for a system that can generate longer arcs to increase energy output while maintaining safe temperature control.
Innovation Solution
The system employs a fluid-filled member with spaced-apart electrodes enclosed in a confining structure, such as a sleeve, to create a narrow channel for ionic current, allowing for longer arcs and controlled energy release, minimizing thermal heating and optimizing shock wave generation for effective plaque treatment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If multiple electrode pairs are used to cover elongated lesions, then axial coverage is improved, but device complexity and risk of tissue damage increase
Solution Approach 1:
The treatment approach is segmented into multiple sequential pulses applied to a single electrode pair, rather than using multiple electrode pairs simultaneously. This allows coverage of elongated lesions through repeated treatment at the same location with different pulse timing and positioning, reducing device complexity while maintaining axial coverage capability
Solution Approach 2:
The system performs preliminary positioning of the catheter and electrode pair at the target lesion site before delivering multiple treatment pulses. This preliminary action allows the same electrode pair to treat different segments of an elongated lesion through sequential pulsing, eliminating the need for multiple electrode pairs
2Strength
If high pressure is applied to fracture calcified lesions, then treatment effectiveness is improved, but risk of arterial rupture and tissue damage increases
Solution Approach 1:
The system applies pressure in periodic, pulsed intervals rather than continuous high pressure. Multiple pulses are delivered with specific timing intervals, allowing tissue to recover between pulses and reducing cumulative damage while maintaining effectiveness in fracturing calcified lesions through repeated stress cycles
Solution Approach 2:
The system uses lower initial pressure pulses that progressively increase in intensity, cushioning the tissue from sudden high-stress exposure. The sequential pulsing allows gradual adaptation and reduces the risk of arterial rupture by building up treatment effect incrementally rather than applying maximum pressure immediately
3Power
If longer arcs between electrodes are used to generate more energy, then plaque disruption efficiency is improved, but thermal heating increases causing tissue damage
Solution Approach 1:
The electrical arc is activated in periodic pulses rather than continuously. This pulsed operation allows the tissue and fluid between electrodes to cool down between pulses, preventing cumulative thermal damage while maintaining high energy delivery during each active pulse for effective plaque disruption
Solution Approach 2:
The system maintains treatment effectiveness through continuous pulsing rather than long continuous arcs. By delivering multiple shorter pulses in succession, the system achieves cumulative energy delivery comparable to continuous operation but with intermittent cooling periods that prevent excessive thermal buildup and tissue damage
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 enables more efficient and safer treatment of calcified lesions by enhancing energy delivery to the targeted plaque while reducing thermal heating and maintaining balloon integrity, thus minimizing vessel damage.
Implementation Method 1
an electrical arc is generated between two spaced-apart electrodes disposed within a fluid-filled member, creating flow and pressure waves
Implementation Method 2
using a fluid-constraining sleeve to confine ionic current and minimize heat dissipation
Implementation Method 3
creating flow and pressure waves... enables more efficient plaque disruption with reduced thermal damage and improved energy conversion to pressure waves
Data Source
AI summary
Various embodiments of the systems, methods and devices are provided for breaking up calcified lesions in an anatomical conduit. More specifically, an electrical arc is generated between two spaced-apart electrodes disposed within a fluid-filled balloon, creating flow and pressure waves. In some embodiments, the electrodes are spaced apart across relatively long distances to create a stronger shock. In some embodiments, the saline ionically conducting between the electrodes is confined to reduce parasitic heating. In some embodiments, the balloon is partially deflated during arc generation.