Sacral Neuromodulation Trialing With Temporary Leads Before Implant
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Solution Overview
Problem
Existing neurostimulation therapies face variability in patient responses, necessitating improved pre-implantation evaluation methods to optimize patient comfort and minimize procedural risks while ensuring long-term therapeutic efficacy.
Innovation Solution
A neuromodulation trial system comprising temporary leads and an external stimulation controller for ambulatory neurostimulation, powered by a battery and using midfield powering technology, allows for a precise and reversible trial period to assess therapeutic benefits before committing to a permanent implant, with shared circuitry ensuring consistency between trial and permanent devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a permanent implant is performed without adequate pre-implantation evaluation, then long-term therapeutic efficacy may be compromised due to patient non-response, but extensive evaluation increases procedural complexity and time
Solution Approach 1:
The patent implements a trial period with temporary leads that allows patients to experience neurostimulation therapy before permanent implantation. This preliminary action enables assessment of therapeutic response and patient comfort, ensuring that only responsive patients proceed to permanent implant, thereby improving predictability of long-term efficacy while maintaining reasonable procedural complexity through standardized trial protocols
2Measurement precision
If trial period is extended to ensure accurate evaluation of therapeutic benefits, then measurement precision improves, but loss of time and patient discomfort increase
Solution Approach 1:
The trial system allows dynamic adjustment of stimulation parameters including amplitude, pulse width, and frequency during the trial period. This enables optimization of therapy settings to achieve accurate evaluation of therapeutic benefits within a shorter timeframe, balancing measurement precision with reduced trial duration and improved patient comfort
3Adaptability or versatility
If different circuitry is used between trial and permanent devices, then adaptability during trial is improved, but reprogramming complexity increases when transitioning to permanent therapy
Solution Approach 1:
The patent employs shared circuitry between trial and permanent neurostimulation devices, including identical pulse generators, control circuits, and programming interfaces. This universal design allows the trial device to provide full configurability and adaptability during the trial period, while ensuring seamless transition to permanent therapy with minimal reprogramming needs, as the same hardware platform supports both trial and permanent implantation scenarios
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system provides a reliable and comfortable trial phase that accurately evaluates neurostimulation effectiveness, reducing unnecessary risks and costs, and facilitates a seamless transition to permanent therapy with reduced reprogramming needs, enhancing patient comfort and cost efficiency.
Implementation Method 1
A neuromodulation trial system comprises temporary leads and an external stimulation controller for ambulatory neurostimulation, powered by a battery
Implementation Method 2
powered by a battery and using midfield powering technology
Data Source
AI summary
A neurostimulation trial system includes an external neurostimulation therapy controller including a processor circuit, a pulse generator circuit, a ground pad configured to be coupled with an external surface of patient skin tissue, and a transceiver circuit configured to communicate with a programmer device. The system can include at least one lead with an electrode that is configured for implantation at a neural tissue site inside a patient body. In an example, the programmer device is configured to communicate therapy instructions to the external neurostimulation therapy controller and is configured to communicate power and/or therapy instructions to an implanted neurostimulation device.