External Pulse Generator Layout for Comfortable Neurostimulation Trials
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Solution Overview
Problem
Conventional neurostimulation systems for trial treatments are bulky, uncomfortable, and do not accurately represent the effectiveness of fully implanted systems, leading to inconsistent treatment outcomes and patient discomfort.
Innovation Solution
A neurostimulation system with an external pulse generator (EPG) featuring a multi-purpose connector receptacle and affixation devices, which is secured to the patient, allowing for a more accurate trial treatment with improved comfort and consistent treatment outcomes by mimicking the fully implanted system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional temporary partly implanted neurostimulation systems are used for trial treatment, then treatment viability can be assessed, but the systems are bulky, uncomfortable and limit patient mobility
Solution Approach 1:
The external pulse generator is designed to replicate the form factor, weight, and operational characteristics of fully implanted pulse generators. This copying approach allows patients to experience the actual treatment conditions during trial periods, assessing viability while maintaining comfort and mobility comparable to permanent implantation.
2Reliability
If conventional temporary partly implanted systems are used, then trial treatment can be conducted, but they do not operate in the same manner as fully implanted systems due to differences between pulse generators or changes in position of neurostimulation leads
Solution Approach 1:
The external pulse generator replicates the operational characteristics, pulse delivery parameters, and control algorithms of fully implanted systems. Neurostimulation leads are positioned and secured to maintain identical spatial relationships as in permanent implantation, ensuring trial results accurately predict permanent system performance.
Solution Approach 2:
The system incorporates adjustable positioning mechanisms and flexible lead routing that allow the external generator to adapt to patient movement and positioning changes, maintaining consistent treatment delivery equivalent to implanted systems throughout the trial period.
3Reliability
If conventional temporary partly implanted systems are used, then trial treatment is possible, but the systems are bulky and limit patient mobility causing patients to elect not to receive treatment
Solution Approach 1:
The external pulse generator is designed to match the dimensions, weight, and ergonomics of fully implanted pulse generators. This allows the trial device to be worn comfortably during daily activities without limiting mobility, enabling patients to accurately assess treatment viability while maintaining normal lifestyle.
Data Source
AI summary
An external pulse generator (EPG) for stimulating a nerve includes a housing including an electrical contact configured to receive a lead type for stimulating the nerve. The housing includes a door covering the electrical contact. The door is configured to be nested within and latched to the housing. The door is configured to swing open to uncover the electrical contact. A receptacle is located on the housing and is configured to receive a first end of an electrical cable. The is configured to be connected to a second lead type for stimulating the nerve. The EPG includes a battery that carries a communication signal and is located between a circuit board and the housing. The EPG includes a ground pad connector extending through the housing. The ground pad connector is attached to a ground pad that is configured to be placed on a surface of a skin of the patient.


