Atraumatic Microlead with Deformable Silicone Cap
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Solution Overview
Problem
Current implantable medical leads face challenges such as stiffness gradients, mechanical fatigue, difficulty in sterilization, and risk of perforation in narrow coronary vessels due to their structure and size, particularly when reduced to less than 1.5 French diameter, which complicates implantation and long-term biostability.
Innovation Solution
A detection/stimulation microlead with a microcable of overall diameter not exceeding 1.5 French, featuring an electrically conductive core cable with a distal end protected by a deformable and incompressible silicone coating and cap, ensuring atraumaticity and adaptability to narrow vessel geometries, reducing the risk of perforation and enhancing mechanical strength and flexibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the lead size is reduced to less than 1.5 French diameter to enable passage through narrow coronary vessels, then the invasiveness is reduced and adaptability to narrow vessels is improved, but the mechanical strength and resistance to fatigue decrease
Solution Approach 1:
The microlead employs a composite structure combining a flexible polymer insulator with embedded metallic conductors (iridium oxide coating on platinum or iridium core). This composite design provides both the flexibility needed for narrow vessel navigation and the mechanical strength required for long-term durability, resolving the contradiction between adaptability and strength.
2Ease of operation
If the lead size is reduced to less than 1.5 French diameter, then the ease of implantation through narrow vessels is improved, but the risk of perforation increases due to lack of structural support
Solution Approach 1:
The microlead utilizes a flexible polymer insulator shell that provides structural support while maintaining softness and compliance with vessel walls. This flexible shell design enables easy implantation through narrow vessels while preventing perforation by distributing mechanical stresses and avoiding sharp edges, thus resolving the contradiction between ease of implantation and perforation risk.
3Reliability
If complex assembly of multiple parts is used to meet lead requirements, then the reliability and biostability are improved, but the device complexity increases and manufacturing difficulty increases
Solution Approach 1:
The microlead integrates multiple functions into a single unified structure: the polymer insulator serves as both electrical insulation and mechanical protection, while the metallic core provides both electrical conductivity and structural support. This merging of functions reduces device complexity and manufacturing difficulty while maintaining reliability and biostability through the synergistic combination of materials.
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 microlead effectively navigates through small coronary vessels without perforation risk, maintaining flexibility and electrical functionality, while ensuring biocompatibility and long-term stability, facilitating less invasive procedures and improved treatment efficacy in cardiology and neurology.
Implementation Method 1
a protection cap in a both deformable and incompressible material, enveloping the coating means
Implementation Method 2
electrically conductive core cable
Data Source
AI summary
An atraumatic detection/stimulation lead is disclosed. The lead includes at least one microcable having a core cable comprising a plurality of elementary metal strands. One of the microcables has provided at its distal end an atraumatic protection device. The atraumatic protection device includes a protective coating on the distal ends of the elementary strands of the microcable, and the protective coating is covered by a protective cap of deformable material. The protective cap may be a conical distal end adapted to deform and axially flatten out. The microcable may have an overall diameter less than or equal to 1.5 French (0.50 mm).