Modular Neurological Screening Adapter for Spinal Cord Stimulation
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Solution Overview
Problem
Existing systems for spinal cord stimulation require multiple adapters and long cables, leading to increased costs, potential damage to electrode leads, and risks of poor connections and miscommunication during the trial phase, which complicates the evaluation of therapy efficacy.
Innovation Solution
An adapter system that includes a pulse generator with a connector member, an external adapter with receptacles for electrode leads, and a single-use test cable with connectors for secure electrical connections, reducing the need for multiple adapters and long cables, and incorporating impedance measuring circuits for real-time feedback.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple adapters (multi-lead trial cable and header) are used to interface electrode leads to the pulse generator, then the system can support both intraoperative testing and trial phase stimulation, but the cost increases and the complexity of the system increases
Solution Approach 1:
The patent combines the functions of the multi-lead trial cable and the header into a single adapter device. This single adapter provides both the cable connection for intraoperative testing and the interface for trial phase stimulation, eliminating the need for separate adapters and reducing system complexity while maintaining versatility across both application phases.
Solution Approach 2:
The adapter is designed with universal functionality to serve multiple purposes: it interfaces electrode leads during intraoperative testing via cable connection and continues to serve as the interface during the trial phase when the pulse generator is worn by the patient. This multi-functional design eliminates the need for multiple specialized adapters.
2Adaptability or versatility
If the electrode leads are disconnected and re-connected between the multi-lead trial cable and the header, then the system can transition from testing to trial phase, but the likelihood of poor connections increases and the electrode leads are at risk of damage
Solution Approach 1:
The adapter is pre-configured with built-in impedance checking capability that automatically verifies connection integrity when electrode leads are first connected. This preliminary action detects and alerts operators to any connection issues before they can cause problems during stimulation, eliminating the need for manual re-checking after disconnection and re-connection events.
Solution Approach 2:
The system incorporates automatic impedance checking that provides real-time feedback on connection quality. When electrode leads are connected to the adapter, the system automatically measures impedance values and alerts operators to any abnormal conditions, ensuring connection integrity is maintained and reducing the risk of poor connections during transitions between testing and trial phases.
3Ease of operation
If long cables are used to connect the electrode leads to the external pulse generator during the trial phase, then the patient can wear the pulse generator during normal daily activities, but the risk of the cable becoming snagged or disconnected increases
Solution Approach 1:
The adapter incorporates a flexible printed circuit board (FPC) that provides the necessary cable flexibility and movement capability for patient mobility during daily activities. The FPC is designed with appropriate flexibility to accommodate patient movement while maintaining stable electrical connections, reducing the risk of snagging and disconnection compared to traditional rigid or overly flexible cables.
4Extent of automation
If impedance testing is performed by a non-sterile programmer instrument operator, then the test can be executed, but additional waiting time is induced and miscommunication may occur
Solution Approach 1:
The adapter incorporates built-in impedance checking capability that allows the system to perform self-diagnosis of connection integrity. When electrode leads are connected, the adapter automatically checks impedance values and provides immediate feedback to the operator, eliminating the need for separate manual testing procedures and reducing waiting time while maintaining automation.
Data Source
AI summary
An adapter system connects to implantable electrode leads. The adapter system has the pulse generator configured to generate electrical stimulation pulses and has a first connector member. The adapter has a housing containing two receptacles. Each receptacle receives an end portion of an electrode lead to establish an electrical connection between the adapter and the electrode lead. The adapter contains a second connector member configured to engage with the first connector member to establish a mechanical connection between the housing and the pulse generator and an electrical connection between the pulse generator and the electrode lead. A test cable electrically connects the pulse generator to the electrode leads for testing the electrode leads. The test cable contains a first connector member configured to engage with the second connector member to establish an electrical connection. The test cable contains a second connector member configured to engage with the first connector member.