Oscillating Impactor Intravascular Lithotripsy Catheter for Calcified CTOs
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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 similar devices are needed for treating occlusions in other body lumens like kidney stones.
Innovation Solution
An IVL catheter with an impactor that delivers mechanical forces to occlusions by translating shock wave energy into mechanical movement, featuring an impactor that oscillates forward and backward, mimicking a jackhammer effect to chisel away at CTOs and create a tunnel for catheter advancement, combined with radial shock waves to crack calcium and make lesions pliable.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional angioplasty balloons are used to treat calcified lesions, then the balloon can be inflated to push calcified plaques back into the vessel wall, but the procedure requires high inflation pressure (greater than 10 atm) which increases the risk of vessel trauma
Solution Approach 1:
The patent replaces the mechanical force system of high-pressure balloon inflation with an acoustic shock wave system. The shock wave generator produces acoustic shock waves that propagate through the vessel wall to crack calcified plaque, eliminating the need for high-pressure balloon inflation and thereby reducing vessel trauma while maintaining plaque modification effectiveness
Solution Approach 2:
The patent changes the physical parameter of energy delivery from mechanical pressure (greater than 10 atm) to acoustic energy (shock waves). This parameter transformation allows plaque modification to occur at lower mechanical stress on the vessel wall, reducing harmful effects while achieving the same therapeutic goal
2Reliability
If atherectomy procedures are used to remove calcified plaque, then the occlusion can be cleared, but the procedure carries high risk of perforation, dissection, or other damage to vasculature
Solution Approach 1:
The patent replaces the mechanical cutting/shaving system of atherectomy with an acoustic shock wave system. The shock waves crack the calcified plaque in place without requiring physical removal, thereby clearing the occlusion while eliminating the risks of perforation and dissection associated with mechanical atherectomy
Solution Approach 2:
The patent introduces acoustic shock waves as an intermediary mechanism to achieve plaque modification. Instead of direct mechanical contact between the catheter and plaque (as in atherectomy), the shock waves serve as an energy mediator that cracks the plaque from a distance, reducing direct mechanical trauma to the vasculature
3Reliability
If cutting or scoring balloons are used to treat calcified lesions, then the balloon can be inflated to modify plaque, but the procedure carries risk of perforation, dissection, or other damage to vasculature
Solution Approach 1:
The patent replaces the mechanical cutting/scoring system with an acoustic shock wave system. The shock waves propagate through the vessel wall to crack calcified plaque without requiring the balloon to exert high mechanical forces that could cause perforation or dissection, thereby achieving plaque modification with reduced vascular 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
The catheter effectively penetrates and treats resistant fibrotic and calcified lesions with minimal vascular trauma by using an impactor to deliver mechanical forces and radial shock waves, reducing the need for multiple devices during treatment.
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
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.