Oscillating IVL Catheter Impactor for Calcified CTO Penetration
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Solution Overview
Problem
Existing catheter devices struggle to effectively penetrate and treat resistant fibrotic and calcified lesions, such as chronic total occlusions (CTOs), while minimizing the risk of trauma to blood vessels, and are challenging to navigate through narrow and tortuous vasculature.
Innovation Solution
An intravascular lithotripsy (IVL) catheter with an impactor that delivers mechanical forces to occlusions by translating shock wave energy into mechanical movement, allowing the impactor to oscillate forward and backward, mimicking a 'jackhammer effect' to chisel away at CTOs, combined with radial shock waves to crack calcium and make lesions pliable.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional angioplasty balloons are pressurized to greater than 10 atm to push calcified plaques back into the vessel wall, then the occluded regions of vasculature can be dilated, but the risk of vessel perforation and dissection increases
Solution Approach 1:
The patent replaces the mechanical force system of high-pressure balloon angioplasty with an acoustic shock wave system. The shock wave generator produces acoustic shock waves that propagate through the conductive fluid in the balloon to modify calcified plaque through acoustic cavitation and mechanical stress, rather than direct mechanical compression. This substitution allows plaque modification at lower pressures, reducing the risk of vessel perforation and dissection while maintaining treatment effectiveness.
Solution Approach 2:
The patent changes the physical parameters of plaque modification by using acoustic shock waves with specific frequency, amplitude, and pulse duration characteristics. Instead of relying on static high pressure, the system uses dynamic acoustic parameters that can be controlled and adjusted to achieve plaque modification at lower overall pressures, thereby reducing harmful effects on the vessel wall.
2Productivity
If atherectomy procedures or angioplasty procedures using cutting or scoring balloons are used to treat calcified lesions, then the calcified plaque can be removed or disrupted, but the risk of perforation, dissection, or other damage to vasculature increases
Solution Approach 1:
The patent replaces mechanical cutting, scoring, or shaving systems with an acoustic shock wave system. The shock waves modify calcified plaque through acoustic cavitation, where rapidly collapsing bubbles generate localized mechanical stress that cracks and disrupts calcium deposits without requiring direct mechanical contact or forceful cutting actions that could damage the vessel wall.
Solution Approach 2:
The patent introduces acoustic shock waves as an intermediary mechanism between the treatment device and the calcified plaque. The shock waves act as a mediator that transfers energy to the plaque through the conductive fluid, enabling plaque modification without direct mechanical interaction between the device and the plaque or vessel wall, thereby reducing the risk of perforation and dissection.
3Reliability
If electrohydraulic generation or laser generation is used to create acoustic shock waves for IVL, then calcified plaque can be modified, but the device complexity increases
Solution Approach 1:
The patent extracts the shock wave generation function from complex integrated systems and implements it as a separate, dedicated module within the catheter. By using electrohydraulic or laser generation as a discrete component rather than attempting to simplify it further, the patent maintains treatment effectiveness while managing complexity through functional separation and modular design.
Solution Approach 2:
The patent employs electrohydraulic or laser generation systems that can serve multiple functions: generating acoustic shock waves for plaque modification, providing a contained environment through the balloon, and enabling controlled delivery of therapeutic energy. This multi-functionality justifies the complexity by consolidating several functions into a single integrated system rather than requiring multiple separate devices.
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 IVL catheter efficiently penetrates and treats resistant fibrotic and calcified lesions with minimal vessel trauma, enabling effective treatment of CTOs and similar occlusions without the risks associated with traditional angioplasty or atherectomy procedures.
Implementation Method 1
For electrohydraulic generation of acoustic shock waves, a conductive solution (e.g., saline) may be contained within an enclosure that surrounds electrodes or can be flushed through a tube that surrounds the electrodes. The calcified plaque modification is achieved by creating acoustic shock waves within the catheter by an electrical discharge across the electrodes. This discharge creates one or more rapidly expanding vapor bubbles that generate the acoustic shock waves.
Implementation Method 2
For laser generation of acoustic shock waves, a laser pulse is transmitted into and absorbed by a fluid within the catheter. This absorption process rapidly heats and vaporizes the fluid, thereby generating the rapidly expanding vapor bubble, as well as the acoustic shock waves that propagate outward and modify the calcified plaque.
Implementation Method 3
These shock waves propagate radially outward and modify calcified plaque within the blood vessels.
Implementation Method 4
the impactor is a component for applying mechanical energy to occlusions by receiving shock wave energy and translating the shock wave energy into mechanical movement of the distal tip of the catheter
Data Source
AI summary
Catheter devices for treating occlusions in body lumen are described herein. The catheter devices may include a tubular body having a distal end, an distal portion elastically connected to the distal end of the tubular body, an impactor connected to the distal portion and separated by a space from the distal end of the tubular body, a distal shock wave emitter located adjacent to the space and connected to a power source, and an enclosure at least partially surrounding each of the distal end of the tubular body, the elastic distal portion, the impactor, and the distal shock wave emitter. The impactor may be configured to move in response to shock waves generated from the distal shock wave emitter, such that a length of the space in the proximal-distal direction increases by between 0.05 mm and 0.6 mm.