Portable Electronic Device for Sacral Nerve Stimulation Testing

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Solution Overview

Problem

Conventional sacral nerve stimulation systems are cumbersome and require significant manual clinician involvement, leading to potentially ineffective test stimulations due to inefficiencies in determining the efficacy of stimulation and implant site for an implantable pulse generator.

Innovation Solution

A portable electronic device with a graphical user interface and processors that establish a communications link with a pulse generator to simulate intermittent electrical coupling by instructing the generator to automatically turn on and off the generation of electrical stimulation pulses for a plurality of cycles, allowing for efficient programming and testing of stimulation parameters.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional test stimulation methods are used, then the stimulation can be applied to the patient, but the process requires significant manual clinician involvement and is cumbersome

Engineering Contradiction:

Improveease of operationVSAvoiddevice complexity

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The system performs self-testing and self-evaluation through automated protocols. The portable electronic device automatically controls the pulse generator, applies test stimulations, and evaluates results without requiring continuous manual intervention from the clinician, allowing the system to serve itself in the testing process.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The system pre-configures multiple test stimulation protocols and parameters before actual testing. The portable device loads predetermined test sequences, electrode configurations, and stimulation parameters in advance, so that when testing begins, the system can execute automatically without real-time manual setup.

Inventive Principle:

Principle #10Preliminary action

2Measurement precision

If manual test stimulation is performed, then the clinician can evaluate stimulation efficacy, but manual errors and inefficiencies occur

Engineering Contradiction:

Improvemeasurement precisionVSAvoidreliability

Core Design Contradiction:

Measurement precisionVSReliability

Solution Approach 1:

The system incorporates automated feedback mechanisms where the portable electronic device continuously monitors stimulation responses, compares results against predetermined criteria, and automatically adjusts parameters or identifies optimal settings. This closed-loop feedback system eliminates manual interpretation errors and provides consistent, reliable evaluation.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The patent replaces manual mechanical operations with electronic automation. The portable device uses electronic signals to control the pulse generator, automatically record responses, and analyze results, substituting the manual mechanical process of clinician-operated test stimulation with an electronic automated system that reduces human error.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Adaptability or versatility

If extensive manual involvement is used for test stimulation, then parameters can be adjusted, but the process becomes time-consuming and inefficient

Engineering Contradiction:

ImproveadaptabilityVSAvoidproductivity

Core Design Contradiction:

Adaptability or versatilityVSProductivity

Solution Approach 1:

The portable electronic device serves multiple functions: it controls the pulse generator, applies various test stimulation protocols, records patient responses, analyzes results, and determines optimal parameters all in one integrated system. This multi-functionality allows extensive parameter adjustment capabilities while maintaining high productivity through automation.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The system employs periodic test stimulation protocols where stimulations are applied in predetermined sequences and intervals automatically. The portable device manages the timing, duration, and repetition of test stimulations according to pre-programmed schedules, enabling comprehensive parameter evaluation without continuous manual intervention and significantly improving testing efficiency.

Inventive Principle:

Principle #19Periodic action

Data Source

PatentUS11116986B2Systems, methods, and devices for performing electronically controlled test stimulation

Publication Date: 2021.09.14 CIRTEC MEDICAL CORP

AI summary

The present disclosure involves systems and methods of programming electrical stimulation therapy for a patient. A communications link is established with a pulse generator that is configured to generate electrical stimulation pulses. An intermittent electrical coupling between the pulse generator and a diagnostic tool is simulated. This simulation is performed by instructing, for a plurality of cycles, the pulse generator to automatically turn on and off the generation of electrical stimulation pulses. Each cycle includes a first time period and a second time period following the first time period. The simulating includes: instructing the pulse generator to generate the electrical stimulation pulses during the first time period; and instructing the pulse generator to stop generating the electrical stimulation pulses during the second time period.