Thermoset Lead Bodies Non-Linear Configuration
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Solution Overview
Problem
Implantable medical devices (IMDs) for treating sleep disorder breathing face challenges due to material limitations, such as silicone material irreversible binding, which complicates implantation and sizing, and existing devices struggle with maintaining effective positioning amidst patient movement.
Innovation Solution
Forming medical lead bodies with non-linear configurations from thermoset materials like silicone, which are flexible and durable, allowing for shape adaptation and preventing irreversible binding between silicone components, thus enhancing patient comfort and device stability during movement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If silicone material is used for IMD components, then biocompatibility and flexibility are improved, but irreversible binding between silicone components occurs complicating implantation and sizing
Solution Approach 1:
The device is divided into multiple silicone components that can be separately handled and implanted. The lead body, electrodes, and other components are segmented to allow independent manipulation during implantation, preventing irreversible binding while maintaining biocompatibility.
Solution Approach 2:
Sizing and positioning adjustments are performed before final implantation. The device allows preliminary action during the implantation process where components can be adjusted and repositioned before being permanently fixed, preventing irreversible binding issues.
2Ease of manufacture
If traditional linear lead configurations are used, then manufacturing simplicity is maintained, but patient comfort and device stability during movement are reduced
Solution Approach 1:
The lead body is configured with non-linear, curved pathways that follow the natural contours of the patient's anatomy. This curved configuration improves device stability and patient comfort during movement while maintaining manufacturing feasibility through molding processes.
Solution Approach 2:
The lead configuration is designed to be dynamic and adaptable to patient movement patterns. The non-linear configuration allows the lead to flex and move with the patient's body without creating stress concentrations that would compromise reliability.
3Device complexity
If silicone components are designed to engage during implantation, then device assembly is simplified, but irreversible binding occurs preventing proper sizing and placement
Solution Approach 1:
Components are designed to engage temporarily during implantation but allow for preliminary adjustments before final positioning. The engagement mechanism permits sizing and placement flexibility before irreversible binding occurs, if at all.
Solution Approach 2:
The engagement parameters between silicone components are carefully controlled to prevent irreversible binding. Material properties, surface treatments, or geometric parameters are modified to ensure components can be adjusted during implantation without permanently fusing together.
Data Source
AI summary
Examples are directed to a system, device and/or method comprising forming at least one lead portion of a medical lead body in a non-linear configuration from a thermoset material. Some examples are directed to a system, device and/or method comprising forming a body supporting at least one contact electrode, the body at least partially defining a re-closable lumen and comprising engaging portions, at least one of the engaging portions being formed from a silicone material.