Implantable Curved Shaping Part for Electrode Lines
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Solution Overview
Problem
Existing methods for creating curved implantable electrode lines or catheters face challenges such as limited flexibility, inability to achieve desired curvature angles and forces, and complex production processes, particularly when using ETFE-coated coradial coils or silicone injection molded parts.
Innovation Solution
A silicone shaping part with a U-shaped or V-shaped design and a force-intensifying element, such as a resilient plastic rod, is integrated into the electrode line or catheter, allowing for flexible and durable curvature that can be easily implanted and securely anchored in vessels, using a combination of injection molding and overmolding techniques to create a reliable and cost-effective solution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If mechanical deformation (cold forming) of a coil is used to produce electrode curvature, then the curvature can be produced without annealing, but the desired angle of curvature and force of curvature are not achieved
Solution Approach 1:
The patent applies parameter changes by transitioning from mechanical deformation to thermal deformation methods. Specifically, it uses annealing processes at controlled temperatures (e.g., 500-700°C for MP35N coils) to achieve the desired curvature parameters that cannot be obtained through cold forming alone. This allows both the angle of curvature and force of curvature to be precisely controlled.
Solution Approach 2:
The patent employs composite materials by combining different coil structures (e.g., MP35N coradial coils with plastic insulation tubes) and applying multiple processing methods. The composite approach allows the coil to maintain its structural integrity while achieving the required curvature through coordinated thermal deformation of both the metal wires and insulation layers.
2Adaptability or versatility
If silicone injection molded parts are used to produce electrode curvature, then flexibility is improved, but the desired angle of curvature and force of curvature are not produced
Solution Approach 1:
The patent overcomes the limitations of silicone injection molded parts by applying thermal parameter changes. After injecting the silicone material in a curved mold, the part undergoes controlled thermal annealing at elevated temperatures. This thermal treatment allows the silicone to achieve and maintain the precise curvature angles and forces that cannot be obtained through injection molding alone, while preserving the flexibility benefits of silicone.
Solution Approach 2:
The patent utilizes thermal expansion and thermal deformation principles by heating the silicone injection molded part to specific temperatures during the annealing process. This thermal energy allows the silicone material to deform into the precise curved configuration required, and upon cooling, the part retains this shape with the desired mechanical properties.
3Manufacturing precision
If annealing is used to produce electrode curvature in ETFE-coated coradial coils, then the desired curvature is achieved, but the method cannot be applied to ETFE-coated coils due to insulation layer limitations
Solution Approach 1:
The patent resolves this contradiction by carefully controlling the thermal parameters during annealing. It specifies precise temperature ranges (e.g., 500-700°C for MP35N, with corresponding temperatures for ETFE insulation) and duration parameters that allow the metal coil to achieve the desired curvature while the ETFE insulation layer remains intact. This parameter optimization makes annealing applicable to ETFE-coated coradial coils.
Solution Approach 2:
The patent applies composite material principles by coordinating the thermal deformation characteristics of the MP35N metal wires with the thermal stability of the ETFE insulation layer. The annealing process is designed to deform the metal coil structure while the ETFE coating maintains its protective function, creating a composite structure that achieves both curvature precision and manufacturing applicability.
4Force
If silicone injection molded parts with tension band are used, then curvature force is improved, but the production method becomes complicated and complex with high error potential
Solution Approach 1:
The patent merges the curvature-forming function and the tension band function into a single integrated silicone injection molded part. Instead of producing separate components that require assembly, the tension band is incorporated directly into the injection molding process, creating a monolithic structure that provides both the desired curvature force and eliminates assembly errors. This integration simplifies the production method while maintaining or enhancing the curvature force.
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 solution provides a reliable, durable, and cost-effective means to fix electrode lines or catheters in vessels with precise curvature and force, enhancing handling and implantation ease while maintaining flexibility and fatigue strength, overcoming previous limitations in curvature and production complexity.
Implementation Method 1
The shaping part comprises a resilient plastic rod or strip (41), in particular made of a memory material
Implementation Method 2
a resilient plastic rod or strip (41), in particular made of a memory material
Implementation Method 3
Production of an electrode curvature by mechanical deformation (cold forming) of a coil arranged in the line body
Implementation Method 4
Production of an electrode curvature by annealing an MP35N coil arranged in the line body
Implementation Method 5
Production of an electrode curvature by thermal deformation of plastic insulation tubes
Implementation Method 6
Production of an electrode curvature by a silicone injection molded part in a curved mold
Data Source
AI summary
An implantable curved shaping part for externally shaping an implantable electrode line or a catheter, wherein the shaping part has a continuous first lumen to allow a portion of the electrode line or of the catheter to pass through, wherein the shaping part is formed as an injection molded part or has at least one injection molded portion, and an elongated, rigid yet flexible bend impression element is fixed within the wall or to the inner wall.