Rounded External Pulse Generator for Comfortable Nerve Stimulation 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 a multi-purpose connector receptacle and affixation devices, including a buttonless, rounded external pulse generator (EPG) that provides a more accurate trial treatment by mimicking fully implanted systems, enhancing patient comfort and consistency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional temporary partly implanted neurostimulation systems are used, then preliminary testing can be conducted, 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 distribution, and external interface characteristics of fully implanted pulse generators. This creates a realistic copy that patients will tolerate during trial periods, allowing accurate assessment of treatment viability without the discomfort of bulky temporary systems
Solution Approach 2:
The external pulse generator employs rounded contours and curved surfaces rather than sharp edges or angular shapes. This ergonomic design reduces pressure points and improves comfort during prolonged wear, enabling patients to maintain normal mobility while undergoing trial treatment assessment
2Reliability
If conventional temporary partly implanted systems are used, then trial treatment can be assessed, but they do not operate in the same manner as fully implanted systems due to differences between pulse generators or changes in position of the neurostimulation leads
Solution Approach 1:
The external pulse generator is designed with universal compatibility to interface with the same neurostimulation leads and electrodes used in fully implanted systems. It supports multiple lead configurations and connection types, ensuring that the device can replicate the operational characteristics of implanted generators while maintaining ease of use during trial periods
Solution Approach 2:
The external pulse generator allows for programmable adjustment of stimulation parameters including pulse width, amplitude, frequency, and channel configuration. These parameters can be modified to precisely match the settings and operational characteristics of the intended fully implanted system, ensuring consistent treatment outcomes across trial and permanent implantation
3Reliability
If conventional temporary partly implanted systems are used, then preliminary testing can be conducted, but many patients elect not to receive a temporary system or a fully implanted system due to discomfort
Solution Approach 1:
The external pulse generator incorporates weight distribution features and ergonomic design elements that counterbalance the natural tendency for discomfort during extended wear. The device is positioned and weighted to distribute load away from sensitive areas, allowing patients to tolerate the trial system long enough to complete accurate treatment viability assessment
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.


