Shock Wave Catheter Emitter Centering for Calcified Lesions
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Solution Overview
Problem
Existing catheter devices struggle to effectively treat calcified lesions in body lumens without causing damage to surrounding soft tissues, as they often result in vessel dissection, perforation, or embolism due to the inability to maintain centering of shock wave emitters, especially in tortuous vasculature.
Innovation Solution
The shock wave catheter features an emitter centering mechanism with narrowed regions or multiple enclosures to keep the inner shaft centered, ensuring a safe operating distance between emitters and the enclosure, thereby preserving the integrity of the device and minimizing vessel damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
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. The shock wave emitters generate acoustic energy that travels through the enclosure and directly fractures calcified plaque without requiring mechanical force, thereby eliminating the preferential expansion away from calcified tissue and the associated risks of dissection and perforation.
Solution Approach 2:
The patent changes the physical state and parameters of the treatment approach by using acoustic energy rather than mechanical pressure. The shock waves deliver controlled acoustic energy to the calcified lesion, allowing for precise energy delivery without the mechanical constraints that cause harmful preferential expansion.
2Productivity
If the catheter is designed with extended distribution of shock wave emitters to treat longer lesions, then fewer repositioning moves are needed, but the enclosures may offset relative to the inner shaft when bent
Solution Approach 1:
The patent incorporates emitter centering features into the enclosure design beforehand, so that when the catheter is bent or navigated through tortuous vasculature, the emitters automatically remain centered relative to the enclosures. This preliminary design feature prevents misalignment before it occurs, maintaining safe operating distances even during navigation.
Solution Approach 2:
The patent introduces asymmetric or non-uniform features in the enclosure design, such as varied cross-sectional shapes or strategic reinforcement zones, that create a self-centering effect. These asymmetric features ensure the inner shaft and emitters remain properly positioned within the enclosures during catheter bending, preventing offset that would compromise treatment safety.
3Force
If cutting or scoring balloon is used to mechanically force focused on calcified lesion, then mechanical force can be concentrated, but protection from dissection or perforation is still not provided
Solution Approach 1:
The patent replaces the mechanical cutting or scoring system with an acoustic shock wave system. Instead of using raised structures or blades that concentrate mechanical force, the shock wave emitters generate acoustic energy that fractures calcified plaque from within, eliminating the need for mechanical contact and the associated risks of dissection and perforation.
4Productivity
If atherectomy device with rotating or oscillating blade is used to cut through occlusion, then calcified tissue can be removed, but frictional heat causes thermal injury and increased clotting risk
Solution Approach 1:
The patent replaces the mechanical blade-based atherectomy system with an acoustic shock wave system. The shock waves fracture calcified plaque without mechanical contact, eliminating frictional heat generation and the associated thermal injury and clotting risks, while still achieving effective plaque modification.
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 design allows for the safe and effective treatment of longer lesions by maintaining emitter alignment, reducing the risk of device failure and vessel damage, while ensuring uniform shock wave application.
Implementation Method 1
acoustic energy generating assemblies for inclusion in shock wave catheter devices
Data Source
AI summary
A catheter includes one or more shock wave generating or emitting sources mounted on or embedded in a main body lumen in positioned within an enclosure, where the enclosure has multiple regions or segments, and wherein one or more of the shock wave sources are located in one or more of the enclosure segments. In some aspects, the enclosure includes a narrowing between regions, in part defining the plurality of segments, the narrowing further functioning to keep the main body lumen centered along the length of the enclosure, thereby maintaining the shock wave sources an operational distance away from the material of the enclosure.