External Pulse Generator for Nerve Stimulation Trials
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Solution Overview
Problem
Existing neurostimulation treatment systems face challenges in providing an accurate representation of treatment viability, patient comfort, and consistent treatment outcomes during trial periods, due to bulky and uncomfortable temporary systems that may not mimic the performance of fully implanted devices.
Innovation Solution
A neurostimulation treatment system featuring an external pulse generator (EPG) with a multi-purpose connector receptacle and affixation devices that securely mount the EPG to the patient, allowing for a more accurate trial of neurostimulation treatment while improving patient comfort and mobility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional temporary neurostimulation systems are used for trial treatment, then treatment viability can be assessed, but the systems are bulky and uncomfortable, limiting patient mobility
Solution Approach 1:
The system divides the temporary neurostimulation device into separate functional components: an implanted lead with electrodes and an external pulse generator. This segmentation allows the implanted portion to remain minimal and comfortable while the external portion can be managed separately, improving patient mobility without compromising treatment assessment capability
Solution Approach 2:
The patent transitions from fully implantable systems to a hybrid configuration where the pulse generator operates externally but connects through a minimal implanted lead. This dimensional change in device placement (from entirely internal to external-internal hybrid) reduces implant burden while maintaining treatment fidelity
2Ease of operation
If temporary partly implanted systems are used for trial treatment, then some treatment assessment can be provided, but they may not operate in the same manner as fully implanted counterparts
Solution Approach 1:
The external pulse generator is designed to replicate the operational characteristics and control features of fully implantable pulse generators. By copying the interface and functionality, the temporary system provides an accurate representation of what the patient will experience with permanent implantation, ensuring treatment outcome consistency
Solution Approach 2:
The system design allows the same lead and connector architecture to be used for both temporary trial periods and permanent implantation. This universal design ensures that the neural stimulation parameters and delivery mechanisms remain consistent across both temporary and permanent configurations
3Productivity
If bulky temporary systems are used for trial neurostimulation, then treatment can be delivered, but patient comfort is reduced and many patients elect not to receive the system
Solution Approach 1:
The pulse generator component is extracted from the implanted system and operated externally during the trial period. This extraction removes the bulk and discomfort associated with large implanted devices while maintaining the ability to deliver therapeutic neural stimulation through the implanted lead
Data Source
AI summary
Systems and methods for providing a trial neurostimulation to a patient for assesssing suitability of a permanently implanted neurostimulation are provided herein. In one aspect, a trial neurostimulation system includes an EPG affixation device that secures the EPG to the patient when connected to a lead extending through a percutaneous incission to a target tissue location, while allowing for ready removal of the EPG for charging or bathing. In another aspect, the system includes an EPG provided with a multi-purpose connector rectacle through which the the EPG can deliver neurostimulation therapy to an implanted lead or the EPG can be charged. In yet another aspect, the EPG can include a multi-purpose connector receptacle that is alternatingly connectable with a purality of differing connector to faciltiate differing types of therapies with one or more neurostimulation devices, ground patches or various other devices, such as charging or testing devices.


