Metallized IVL Catheter Electrodes for Smaller Profile Assembly
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Solution Overview
Problem
Conventional manufacturing processes for IVL catheters are labor-intensive, leading to high costs and inefficiencies, and existing catheters have large diameters that hinder navigation through calcified vessels.
Innovation Solution
The use of a metallization layer formed as a flexible circuit or via wafer fabrication to create electrode assemblies, reducing manual labor and enabling smaller catheter diameters, allowing for batch manufacturing and improved navigation through occluded vasculature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If conventional manufacturing processes are used for IVL catheters, then electrode assemblies can be manufactured, but the process is labor-intensive leading to high costs and inefficiencies
Solution Approach 1:
The patent replaces manual mechanical assembly operations with automated PCB fabrication processes. The electrode assembly is manufactured using standard PCB industry processes including copper deposition, etching, and lamination, which are highly automated and efficient compared to conventional manual wire wrapping and electrode attachment methods.
Solution Approach 2:
The patent changes the manufacturing parameters from manual assembly operations to automated PCB fabrication parameters. By treating the electrode assembly as a PCB product rather than a custom medical device component, the manufacturing process leverages established automated processes with precise control over trace geometry, material properties, and assembly parameters.
2Length of moving object
If existing catheter designs are used, then electrode assemblies can be manufactured, but the catheters have large diameters that hinder navigation through calcified vessels
Solution Approach 1:
The patent uses thin flexible PCB substrates to support the electrode traces, enabling the catheter to achieve a small diameter while maintaining structural integrity. The flexible nature of the PCB allows it to conform to the curved path of calcified vessels without requiring a large catheter diameter for rigidity or support.
Solution Approach 2:
The patent transitions from three-dimensional wire-wrapped electrode assemblies to two-dimensional planar PCB traces. This dimensional reduction allows the electrode assembly to be flattened and integrated into a thin catheter profile, significantly reducing the catheter diameter while maintaining all necessary electrode functions.
3Loss of time
If manual assembly processes are used, then electrode assemblies can be manufactured, but production time is excessive
Solution Approach 1:
The patent replaces manual mechanical assembly with automated PCB fabrication processes. The electrode assembly is manufactured using standard PCB industry processes including copper deposition, etching, and lamination, which are highly automated and efficient compared to conventional manual wire wrapping and electrode attachment methods.
Solution Approach 2:
The patent performs preliminary actions by pre-manufacturing electrode assemblies as PCB components before final catheter assembly. The PCB industry's mature automated processes create ready-to-use electrode assemblies that can be directly integrated into catheters, eliminating the need for time-consuming on-site manual assembly operations.
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 approach enhances manufacturability, reduces production time and costs, and enables catheters with smaller profiles to treat narrower and more severely occluded regions with reduced risk of tissue damage.
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 metallization layer may be covered by an insulative cover having cutouts such that one or more regions of the trace(s) of the metallization layer are exposed, for example in regions where the cover has been etched off or removed.
Data Source
AI summary
A catheter for treating a stenosis in a body lumen includes an elongate tube; a member sealed to a distal end of the elongate tube that is fillable with a conductive fluid; a metallization layer comprising at least one trace forming at least one inner electrode, the metallization layer being connected to at least one wire; and at least one outer electrode extending radially outwardly of the metallization layer and separated from the at least one inner electrode by at least one gap such that, when a voltage pulse is applied to the inner and outer electrodes, current flows across the at least one gap to generate at least one shock wave.