Molded Electrical Stimulation Lead with Integrated Spacers
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Solution Overview
Problem
Current implantable electrical stimulation systems face challenges in efficiently manufacturing leads with integrated conductive contacts and non-conductive spacers that maintain electrical isolation while ensuring biocompatibility and ease of implantation.
Innovation Solution
The method involves disposing conductive contacts in a spaced-apart longitudinal arrangement within a mold, coupling them to conductive wires, and using a non-conductive material to form spacers between the contacts, creating a stable and biocompatible electrical stimulation lead with a stylet tube for implantation support.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conductive contacts are disposed in a spaced-apart longitudinal arrangement within a mold and non-conductive material is molded between adjacent pairs, then electrical isolation between contacts is achieved, but manufacturing complexity increases due to the molding process
Solution Approach 1:
The patent combines the formation of spacers and contacts into a single molding process. The mold cavity includes both contact cavities and spacer cavities, allowing simultaneous formation of all components in one manufacturing step, thereby reducing overall process complexity despite the complexity of individual components
Solution Approach 2:
The non-conductive material serves as an intermediary substance that fills the spaces between conductive contacts to provide electrical isolation. This material acts as a mediator that enables the contacts to function independently while maintaining a unified structure through the single-step molding process
2Stability of the object's composition
If a stylet tube is disposed within the mold to provide implantation support, then device stability is improved, but manufacturing precision requirements increase
Solution Approach 1:
The stylet tube is positioned within the mold cavity before the non-conductive material is molded. This preliminary placement ensures proper positioning and alignment of the stylet tube relative to the conductive contacts and spacer structures, achieving the required precision through advance preparation rather than post-manufacturing adjustment
3Reliability
If conductive wires are coupled to conductive contacts, then electrical conductivity is achieved, but manufacturing time increases
Solution Approach 1:
Conductive wires are positioned within the mold cavity before the non-conductive material is molded. This preliminary placement ensures proper alignment and coupling with the conductive contacts, allowing electrical conductivity to be established during the molding process itself rather than requiring separate post-manufacturing steps
Data Source
AI summary
A method of making an electrical stimulation lead includes disposing conductive contacts in a spaced-apart longitudinal arrangement within a mold. A portion of a stylet tube is disposed within the mold, and the stylet tube extends through the conductive contacts. Conductive wires are positioned external to the stylet tube and each contact is coupled to at least one of the wires. A non-conductive material is molded between adjacent pairs of the contacts, around the wires, and over the stylet tube, to form a portion of the lead. This portion includes the contacts, the stylet tube, the wires, and one or more non-conductive spacers formed from the non-conductive material. Finally, the portion of the lead is removed from the mold. Another method includes placing a temporary tube around the conductive contacts and forming spacers by introducing flowable, curable, non-conductive material within the tube and between the conductive contacts.