Laser IVL Catheter With Fluid Enclosure for Consistent Shock Waves
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Solution Overview
Problem
Existing shock wave generating devices for treating calcified lesions in body lumens, such as Mitral Annular Calcification (MAC) and Chronic Total Occlusions (CTO), suffer from electrode assemblies, and fibrotic tissue buildup, are inefficient and degrade over time due to electrode degradation, leading to inconsistent treatment capabilities.
Innovation Solution
A laser IVL system with a catheter that includes an elongate sheath capped with a fluid-filled enclosure, using optical fibers to generate consistent forward-directed shock waves and/or cavitation bubbles, allowing for adjustable light properties to target specific lesions effectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If electrode assemblies are used to generate shock waves, then shock wave generation is achieved, but treatment consistency degrades over time due to electrode degradation
Solution Approach 1:
The patent replaces the electrohydraulic shock wave generation system with a laser-based optical system. The laser energy is transmitted through optical fibers to a distal enclosure where it interacts with fluid to generate shock waves. This substitution eliminates electrode degradation issues entirely, as the laser system has no consumable electrodes that degrade over time, thereby ensuring consistent treatment capability throughout the device service life.
Solution Approach 2:
The patent changes the fundamental energy delivery mechanism from electrical to optical. By using laser energy with controllable parameters (wavelength, pulse duration, energy level) that can be precisely regulated without degradation, the system maintains consistent shock wave generation. The optical properties of the laser can be adjusted to optimize treatment for different lesion types while maintaining reliability over time.
2Reliability
If laser energy is transmitted into fluid to generate shock waves, then consistent shock wave generation is achieved, but device complexity increases
Solution Approach 1:
The patent employs a nested structure where the optical fiber is contained within the catheter shaft, which in turn contains the fluid-filled distal enclosure. This nesting approach allows the complex laser IVL system to be delivered through a relatively simple catheter structure that can be advanced through the vasculature. The optical fiber terminates at the distal end where the enclosure is filled with fluid, creating a compact integrated system.
Solution Approach 2:
The patent introduces fluid as an intermediary medium between the laser energy and the calcified lesion. The laser energy is transmitted through the optical fiber into the fluid contained in the distal enclosure, where it generates shock waves that then propagate through the enclosure wall to treat the lesion. This intermediary approach simplifies the direct interaction requirements while maintaining effective energy transfer.
3Adaptability or versatility
If light properties are adjusted to target specific lesions, then treatment adaptability is improved, but control complexity increases
Solution Approach 1:
The patent utilizes the ability to change laser parameters (wavelength, pulse duration, energy level) to adapt treatment to different lesion types. By adjusting these optical parameters, the system can optimize shock wave generation for varying calcification densities and lesion characteristics without requiring physical changes to the device structure, maintaining simplicity while achieving versatility.
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 laser IVL system provides highly consistent and reproducible shock waves, optimizing treatment efficiency by tuning light properties for different lesion types, reducing electrode degradation issues and improving treatment outcomes.
Implementation Method 1
transmit the received light into a distal region of the catheter that is enclosed by the conical enclosure to generate shock waves and/or cavitation bubbles in the fluid
Implementation Method 2
light energy transmitted into the enclosed distal region can generate shock waves and/or cavitation bubbles in the fluid
Implementation Method 3
light energy transmitted into the enclosed distal region can generate shock waves and/or cavitation bubbles in the fluid
Implementation Method 4
Energy from these shock waves and/or cavitation bubbles can be transmitted through the enclosure and into a lesion to treat stenosis
Data Source
AI summary
Laser IVL systems and methods are disclosed. A laser IVL system can include at least one light energy source and a catheter. The catheter can include an elongate sheath, an enclosure sealed to a distal end of the elongate sheath, and at least one optical fiber contained within the elongate sheath. The enclosure may have a fill volume less than 10 mL and may be fillable with a fluid. The at least one optical fiber can be optically coupled to receive light from the at least one light energy source and configured to transmit the received light at a light emitting region of the at least one optical fiber into a distal region of the catheter that is enclosed by the enclosure to generate shock waves in the fluid.