External Stimulator Patch Assembly for Sterile Lead Testing
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Solution Overview
Problem
Existing external stimulators used for initial programming and testing of implanted stimulation leads are cumbersome, uncomfortable for patients, and require maintaining sterility of proximal lead portions, which often necessitate replacement after the testing period.
Innovation Solution
An external patch system with a substrate, lead connectors, and electrodes that provides a sterile, water-resistant attachment for the stimulator and leads, allowing for comfortable patient use and maintaining sterility during the testing period.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional external stimulators are used for programming and testing, then the stimulator can provide therapeutic benefits, but the device becomes cumbersome and uncomfortable for patients
Solution Approach 1:
The system is divided into separate components: an external stimulator and a wearable patch assembly. The patch substrate with lead connectors and electrodes is separated from the stimulator body, allowing the stimulator to be removed while maintaining the patch on the patient's skin for continued lead access and comfort.
Solution Approach 2:
The patch substrate acts as an intermediary component between the stimulator and the patient's body. It provides a stable interface for lead connection and maintains sterile conditions while allowing the stimulator to be detached, thereby improving patient comfort without compromising therapeutic function.
2Reliability
If proximal lead portions are kept sterile during testing, then infection risk is reduced, but the leads must be replaced after the testing period
Solution Approach 1:
The sterile field requirement is extracted and applied only to the patch-substrate interface, not the entire lead system. The distal implanted portion of the lead remains sterile and can be reused, while the proximal portion on the patch can be replaced without affecting the implanted segment, thereby extending lead usage duration.
Solution Approach 2:
The patch is designed to maintain sterility at the lead connection point before and during the testing period. By preliminarily establishing this sterile barrier, the system allows for extended use of the implanted lead portion beyond the initial testing period, reducing the need for lead replacement.
3Ease of operation
If the external patch provides water-resistant protection, then patient comfort and hygiene are improved, but the device complexity increases
Solution Approach 1:
The patch substrate is constructed as a thin, flexible, water-resistant membrane that provides protection without adding significant complexity. This thin-film approach maintains patient comfort and hygiene while avoiding the need for complex sealing mechanisms or bulky protective structures.
Data Source
AI summary
An external patch for a stimulation system includes a patch substrate configured for attachment to skin of a patient, the patch substrate having an interior side and an exterior side; at least one lead connector disposed on the interior side of the patch substrate and including connector contacts, each of the at least one lead connector configured to receive a proximal end portion of a stimulation lead for electrically coupling terminals of the stimulation lead to the connector contacts; patch contacts extending from the interior side of the patch substrate to the exterior side of the patch substrate and configured for electrically coupling to a stimulator; and conductors extending along, within, or on the interior side of the patch substrate and electrically coupling the patch contacts to the connector contacts.