Lead Coupling Device Wireless Implant Testing
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Solution Overview
Problem
The implantation of medical leads is cumbersome and time-consuming due to the need for frequent sterilization and handling of programmer cables, which can contaminate the sterile field and require repositioning of the lead, leading to potential infections.
Innovation Solution
A lead coupling device with integrated pulse generator, power source, and wireless communication module that allows for real-time measurements and navigation of the lead within the sterile field, eliminating the need for physical cables and enabling secure, efficient placement and verification of lead positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If programmer cables are used to connect to the lead during implantation, then electrical connectivity for testing is achieved, but the risk of contamination and infection increases due to cable handling
Solution Approach 1:
The patent extracts the electrical connectivity function from the external programmer cable system and integrates it directly into the lead coupling device. The coupling device includes electrical contacts that interface with the lead, eliminating the need for separate programmer cables to penetrate the sterile field during implantation and testing.
Solution Approach 2:
The lead coupling device serves as an intermediary component between the external programmer and the implanted lead. It provides the electrical interface within the sterile field, allowing the programmer to communicate with the lead without requiring direct cable connection through the sterile barrier.
2Manufacturing precision
If the lead is repositioned during implantation, then optimal positioning is achieved, but the procedure becomes more time-consuming and increases contamination risk
Solution Approach 1:
The coupling device enables preliminary testing and verification of lead functionality and positioning immediately after initial placement, before final implantation. This allows for real-time assessment of lead performance and positioning accuracy, reducing the need for time-consuming repositioning operations.
Solution Approach 2:
The integrated electrical contacts provide immediate feedback on lead functionality and positioning during the implantation procedure. This real-time feedback mechanism allows the surgeon to verify correct placement and adjust if necessary, reducing the likelihood of discovering positioning errors after implantation is complete.
3Reliability
If multiple sterilization steps are performed on cables and instruments, then contamination risk is reduced, but the implantation procedure becomes more complex and time-consuming
Solution Approach 1:
The patent combines the electrical interface, testing capability, and lead coupling functions into a single integrated device that can be sterilized as one unit. This eliminates the need for separate sterilization procedures for multiple components (cables, connectors, instruments) and simplifies the overall sterilization process while maintaining infection prevention.
Data Source
AI summary
A lead coupling device adapted for coupling to a lead and methods for using the coupling devices are provided. The coupling device includes a housing assembly having a proximal opening and a distal opening. The coupling device also has a lead receiving channel that is disposed between the two openings to receive a lead therethrough. Various electronics components may also included in the coupling device that enable operations such as sensing, delivery of electrical energy and wireless communication between the coupling device and an external device.


