Spinal Cord Stimulation Therapy Program Testing Automation

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Solution Overview

Problem

Current spinal cord stimulation systems for pain relief rely on paresthesia to mask pain, which can lead to errors in identifying optimal therapy programs due to the lack of immediate feedback in high frequency SCS systems that do not generate paresthesia.

Innovation Solution

A method for systematically testing multiple therapy programs in spinal cord stimulation systems by automatically activating and switching between them over a set period, allowing patient input on pain relief to be correlated with each program, ensuring thorough testing without immediate sensory feedback.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If high frequency electrical pulses are used to treat pain without generating paresthesia, then pain relief is achieved without uncomfortable sensations, but immediate feedback for identifying optimal therapy programs is lost

Engineering Contradiction:

Improveuncomfortable paresthesia sensationVSAvoidaccuracy in identifying optimal therapy programs

Core Design Contradiction:

Object-affected harmful factorsVSMeasurement precision

Solution Approach 1:

The system implements automated feedback collection by querying the patient at predetermined times during the trial period to obtain pain relief assessments. This feedback is then correlated with the currently active therapy program and stored for analysis, enabling accurate identification of optimal programs despite the absence of immediate paresthesia feedback.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

Multiple therapy programs are pre-configured and automatically activated in sequence before the trial period begins. The system proactively cycles through different programs at predetermined intervals, ensuring that comprehensive testing is performed in advance without requiring manual intervention during the trial period.

Inventive Principle:

Principle #10Preliminary action

2Ease of operation

If manual testing of therapy programs is conducted with clinician placement and patient switching, then patient feedback can be collected, but errors in identifying optimal programs and increased service burden occur

Engineering Contradiction:

Improvepatient ability to test programsVSAvoidaccuracy in identifying optimal therapy programs

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The system enables self-service by automatically cycling through therapy programs and querying the patient for feedback without requiring manual clinician intervention. The signal generator autonomously manages program activation, timing, and data collection, reducing service burden while maintaining reliability through systematic automated testing.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The manual mechanical process of clinician program placement and patient switching is replaced with an automated electronic system. The signal generator automatically activates different programs at predetermined times and collects patient feedback electronically, eliminating human error and increasing reliability.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Productivity

If patients test multiple therapy programs manually during trial period, then program effectiveness can be assessed, but insufficient testing time per program and practitioner workload increase

Engineering Contradiction:

Improveefficiency of program identificationVSAvoidtime required for comprehensive testing

Core Design Contradiction:

ProductivityVSLoss of time

Solution Approach 1:

The system implements periodic action by automatically activating different therapy programs at predetermined time intervals during the trial period. Each program is activated for a specific duration, allowing systematic rotation through all programs without requiring continuous patient manual switching, thereby optimizing both testing completeness and time efficiency.

Inventive Principle:

Principle #19Periodic action

Data Source

PatentUS10569087B1Systems and methods for systematically testing a plurality of therapy programs in patient therapy devices

Publication Date: 2020.02.25 NEVRO CORP

AI summary

Methods for systematically testing a plurality of therapy programs in a spinal cord modulation system, and associated systems are disclosed. A representative method comprises loading a plurality of therapy programs into a signal generator, wherein individual therapy programs include parameters specifying electrode configuration, signal amplitude, and/or signal frequency. The programs are automatically activated for an automatically instructed period of time. The method includes automatically changing from one therapy program to another after the instructed period of time. The patient is queried for patient input corresponding to the therapy programs. The patient input is received via a remote. The patient input is correlated with a corresponding time of day and recorded in the signal generator. Thereafter, the patient input is retrieved from the signal generator.