Trial Lead Preventer for Secure External Coupling
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Solution Overview
Problem
Current implantable electrical stimulation systems face challenges in efficiently testing and positioning leads within patients during trial stimulations, as existing leads are not designed to prevent improper coupling with implantable control modules, leading to potential misplacement or ineffective therapy.
Innovation Solution
A trial lead with a preventer having a smaller diameter than the lead body, which is configured to prevent terminals from making contact with connector contacts in implantable control modules, ensuring proper coupling only with external trial stimulation systems, and a specialized operating room cable with a lead connector that mechanically locks the trial lead, preventing incorrect electrical coupling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing leads are used without a preventer, then the lead can be coupled with any connector including implantable control modules, but this leads to potential misplacement or ineffective therapy due to improper coupling
Solution Approach 1:
The patent converts the potential harm of improper coupling into a benefit by using the diameter mismatch as a protective mechanism. The preventer's smaller diameter creates a physical barrier that prevents incorrect coupling with implantable control modules, while still allowing proper coupling with trial stimulators through appropriately designed connectors with larger apertures.
Solution Approach 2:
The preventer acts as an intermediary element between the lead body and connectors. It mediates the coupling process by physically blocking improper connections while permitting proper ones, thus ensuring that only compatible connectors (trial stimulator connectors with larger apertures) can establish electrical contact.
2Reliability
If a preventer with smaller diameter is added to the lead, then improper coupling with implantable control modules is prevented, but the device complexity increases
Solution Approach 1:
The lead is segmented into distinct functional zones: the lead body with standard diameter for proper lead functions, and the preventer with smaller diameter for protective functions. This segmentation allows each component to perform its specific role without interfering with the other, adding safety without compromising overall lead functionality.
Solution Approach 2:
The protective function is extracted from the lead body by adding a separate preventer component. This extraction allows the lead body to maintain its original design and functionality while the preventer provides the additional safety mechanism, minimizing the impact on overall device complexity.
3Adaptability or versatility
If the preventer diameter is made smaller than the lead body, then coupling with trial stimulator connectors is enabled while blocking implantable control module connectors, but manufacturing precision requirements increase
Solution Approach 1:
The preventer exhibits local quality by having a specifically controlled smaller diameter only in the region where it interfaces with connectors. The lead body maintains its standard diameter and properties elsewhere. This localized dimensional variation allows connector selectivity without requiring the entire lead to be manufactured with tighter tolerances.
Data Source
AI summary
A trial electrical stimulation lead includes a lead body having a distal end portion, a proximal end portion, and a longitudinal length; electrodes disposed along the distal end portion of the lead body; terminals disposed along the proximal end portion of the lead body; conductors electrically coupling the terminals to the electrodes; and a preventer extending proximally from the proximal end portion of the lead body. The preventer has a diameter smaller than a diameter of the lead body. The preventer prevents coupling of the trial electrical stimulation lead to an implantable control module, but permits coupling to an external trial stimulation system.