Braided Coil Liner for Cardiac Lead Oxidation Protection
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Solution Overview
Problem
Existing medical electrical leads for cardiac rhythm management systems face challenges in maintaining structural integrity over extended service periods, necessitating complete extraction without degradation or failure.
Innovation Solution
The implementation of a braided liner composed of multiple ribbons, primarily made of polyimide or polyethylene terephthalate materials, which surrounds the electrical conductor to prevent metal ion oxidation and maintain lead integrity, combined with a method of manufacturing that includes braiding, compressing, and tensioning the liner to enhance structural strength.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If a traditional lead structure is used, then the lead can be implanted and function for extended periods, but the lead body degrades over time making complete extraction difficult or impossible
Solution Approach 1:
The lead is divided into separable components: a permanent lead body and a temporary helical electrode assembly connected by a degradable connector. The connector contains degradable material that allows the distal assembly to separate from the lead body after implantation, enabling complete extraction of the lead body while leaving the electrode in place.
Solution Approach 2:
The connector is designed with degradable material intended to fail after a predetermined period, serving its purpose temporarily to deliver the electrode and then allowing separation. This disposable component enables the permanent lead body to be fully extracted after use.
2Ease of operation
If the lead is designed for complete extraction, then structural integrity can be maintained, but the complexity of ensuring degradation mechanisms increases
Solution Approach 1:
A degradable connector serves as an intermediary component between the permanent lead body and the temporary helical electrode assembly. This mediator allows the two permanent components to be connected during implantation and then naturally separate after a predetermined period through degradation, simplifying the extraction process.
Solution Approach 2:
The connector automatically degrades and fails after a predetermined period without requiring external intervention. The degradation mechanism is self-contained within the connector material, which naturally breaks down over time to enable separation and extraction.
3Use of energy by moving object
If metal conductors are used, then electrical conductivity is achieved, but metal ion oxidation degrades the conductor over time
Solution Approach 1:
An insulation coating acts as an intermediary barrier between the metal conductor and the surrounding environment. This protective layer prevents direct contact between the metal ions and oxidizing agents, eliminating metal ion oxidation while maintaining electrical conductivity through the coated conductor.
Solution Approach 2:
The insulation coating creates an inert environment around the metal conductor, preventing chemical reactions between the metal and oxidizing substances in the body. This protective barrier maintains the conductor's integrity and electrical properties over extended periods.
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 braided liner effectively prevents metal ion oxidation, ensuring the lead's structural integrity and ease of extraction, even after prolonged use, thereby enhancing the reliability and durability of the medical electrical leads.
Implementation Method 1
the braided liner effectively prevents metal ion oxidation
Data Source
AI summary
An implantable lead for use with an implantable medical device (IMD) includes a tubular lead body, a proximal connector at the proximal end of the lead body configured for mechanically and electrically coupling the lead to the IMD, a helical electrode extending distally from a distal tip of a distal region of the lead body, a braided liner positioned in a first lead body lumen in the tubular lead body, and a first electrical conductor extending through a liner lumen in the braided liner.