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

VSEngineering 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

Engineering Contradiction:
Improvetreatment viability assessment accuracyVSAvoidpatient mobility and comfort
Core Design Contradiction:
ReliabilityVSEase of operation

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

Inventive Principle:
Principle #1Segmentation

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

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

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

Engineering Contradiction:
Improvetrial treatment accessibilityVSAvoidtreatment outcome consistency
Core Design Contradiction:
Ease of operationVSReliability

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

Inventive Principle:
Principle #26Copying

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

Inventive Principle:
Principle #6Universality (Multi-functionality)

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

Engineering Contradiction:
Improvetreatment delivery capabilityVSAvoidpatient discomfort
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

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

Inventive Principle:
Principle #2Taking out (Extraction)

Data Source

PatentUS20250161700A1External pulse generator device and associated methods for trial nerve stimulation
Publication Date: 2025.05.22 AXONICS INC
  • US20250161700A1 patent drawing
  • US20250161700A1 patent drawing
  • US20250161700A1 patent drawing

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.