Annular Loop Shock Wave Catheter for Calcified Lesion Treatment
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Solution Overview
Problem
Existing catheter-based treatments for calcified lesions, such as angioplasty and atherectomy, risk vessel damage due to preferential expansion and embolism, while IVL devices are ineffective for larger body lumens like structural heart anatomy due to rapid sonic decay.
Innovation Solution
Catheters with annular loop shock wave emitters and elongate slots improve sonic output and emitter durability, positioning emitters near lesions to treat calcified tissues effectively without harming surrounding tissues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If traditional dilation balloon angioplasty is used to treat calcified lesions, then the balloon can expand to dilate the vessel, but the balloon preferentially expands away from hard calcified tissue causing vessel dissection or perforation
Solution Approach 1:
The patent replaces the mechanical balloon expansion system with an acoustic shock wave system. Shock wave emitters generate acoustic energy that propagates through the vessel wall to fracture calcified plaque without requiring direct mechanical contact or high-pressure balloon expansion, thereby eliminating the preferential expansion away from calcified tissue and associated vessel damage risks
Solution Approach 2:
The patent changes the physical state and parameters of energy delivery from mechanical pressure (balloon expansion at >10 atm) to acoustic energy (shock waves with specific frequency and intensity). This parameter change allows energy to be delivered directly to calcified tissue through the vessel wall, treating the lesion in situ without mechanical distortion of the vessel
2Manufacturing precision
If cutting or scoring balloon is used to mechanically cut calcified lesion, then mechanical force can be focused at the raised structure location, but the balloon still expands preferentially away from hardened tissue causing dissection
Solution Approach 1:
The patent replaces the mechanical cutting/scoring system with an acoustic shock wave system. Instead of using raised structures on a balloon to focus mechanical force, the patent uses shock wave emitters that generate acoustic energy focused at the treatment site, eliminating the need for balloon expansion and associated dissection risks while maintaining precise energy delivery to calcified tissue
3Productivity
If atherectomy device with rotating or oscillating blade is used to cut through occlusion, then the blade can debulk calcified tissue, but the device generates frictional heat causing thermal injury and increases risk of dissection and perforation
Solution Approach 1:
The patent replaces the mechanical blade-based atherectomy system with an acoustic shock wave system. Instead of using rotating or oscillating blades that generate frictional heat and mechanical trauma, the patent uses shock wave emitters that fracture calcified plaque through acoustic energy, eliminating thermal injury and reducing mechanical trauma to the vessel wall
Solution Approach 2:
The patent changes the mechanism of tissue removal from mechanical cutting (blade contact) to acoustic fracturing (shock wave propagation). This parameter change eliminates frictional heating and reduces the risk of thermal injury and vessel dissection while maintaining effective calcified tissue removal
4Object-affected harmful factors
If IVL device is used to treat calcified lesions, then acoustic pressure can break up calcified regions without harming surrounding tissue, but the device is ineffective for larger body lumens due to rapid sonic decay
Solution Approach 1:
The patent transitions from treating small vessel lumens to treating larger body lumens (such as cardiac valves) by adapting the shock wave emitter configuration. The emitters are positioned and oriented to effectively deliver acoustic energy across the larger anatomical dimensions, overcoming the rapid sonic decay that limits IVL effectiveness in larger structures
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 catheters provide durable and low-profile treatment of calcified lesions with reduced risk of vessel damage and embolism, enhancing treatment efficacy in larger body lumens.
Implementation Method 1
The IVL device is configured to generate acoustic waves, specifically, ultrasonic short pressure pulses (also known as 'shock waves')
Implementation Method 2
The acoustic pressure of the shock waves may crack and disrupt the calcified regions near the IVL device
Implementation Method 3
two non-exhaustive examples of which are electrohydraulic and laser-based IVL devices
Data Source
AI summary
A catheter for generating shock waves, the catheter comprising: a catheter body; an emitter support member configured to extend at least partially distally of a distal end of the catheter body, where the emitter support member comprises a pre-formed distal portion, where the pre-formed distal portion is configured to coil into an annular loop around at least a portion of a longitudinal axis of the catheter body; a plurality of shock wave emitters mounted to the emitter support member; and an enclosure enclosing the plurality of shock wave emitters.