Temporal Variation in Stimulation Programs for Therapeutic Efficacy

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Solution Overview

Problem

Current implantable electrical stimulation systems face challenges in optimizing stimulation parameters to achieve desired therapeutic effects while minimizing side effects, as they often require manual programming and lack efficient methods to identify suitable parameter combinations for complex conditions.

Innovation Solution

A method and system for generating temporally-varied stimulation programs by selecting multiple sets of stimulation parameter values based on observed clinical effects, where each set is applied during non-overlapping time intervals, allowing for sequential or random ordering, and adjusting parameters such as electrode selection, amplitude, and pulse frequency to achieve optimal therapeutic outcomes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple sets of stimulation parameter values are applied sequentially in non-overlapping time intervals, then therapeutic efficacy is improved by balancing therapeutic effects and side effects, but device complexity increases due to temporal variation requirements

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies periodic action by implementing temporal variation of stimulation parameters through non-overlapping time intervals. Multiple sets of stimulation parameter values are applied in a periodic sequence, where each set is active during a specific time interval and inactive during others. This temporal patterning allows the system to achieve different therapeutic effects at different times, balancing therapeutic benefits with side effect management, while the periodic nature provides a structured approach that manages complexity.

Inventive Principle:
Principle #19Periodic action

2Ease of operation

If manual programming is used to optimize stimulation parameters, then ease of operation is maintained, but productivity decreases due to time-consuming parameter adjustment

Engineering Contradiction:
Improveease of operationVSAvoidproductivity
Core Design Contradiction:
Ease of operationVSProductivity

Solution Approach 1:

The patent implements self-service by enabling the stimulation system to automatically select and apply appropriate stimulation parameter sets based on pre-defined temporal patterns. The system autonomously manages the switching between multiple parameter sets during non-overlapping time intervals without requiring continuous manual intervention. This automation significantly reduces the time required for parameter optimization while maintaining ease of operation through programmable templates that can be configured in advance.

Inventive Principle:
Principle #25Self-service

3Device complexity

If single set of stimulation parameters is used continuously, then device complexity is minimized, but adaptability decreases in responding to varying clinical effects

Engineering Contradiction:
Improvedevice complexityVSAvoidadaptability
Core Design Contradiction:
Device complexityVSAdaptability or versatility

Solution Approach 1:

The patent applies dynamics by transitioning from static, continuous application of a single stimulation parameter set to dynamic, time-varying application of multiple parameter sets. The system dynamically switches between different stimulation configurations during non-overlapping time intervals, allowing adaptation to varying clinical needs and effects. This dynamic approach enhances versatility by enabling the system to respond to different therapeutic requirements throughout the day while maintaining manageable complexity through structured temporal patterns.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentUS20240157151A1Systems and methods for generating and using stimulation programs with temporal variation
Publication Date: 2024.05.16 BOSTON SCI NEUROMODULATION CORP
  • US20240157151A1 patent drawing
  • US20240157151A1 patent drawing
  • US20240157151A1 patent drawing

AI summary

A method for generating a stimulation program includes selecting sets of stimulation parameter values, where at least two stimulation parameter values of each set are selected based on at least one specified clinical effect observed for previous stimulation instances. The at least one specified clinical effect is different for at least two of the sets of stimulation parameter values. The method also includes generating a stimulation program that includes application of stimulation during non-overlapping time intervals, wherein, for each of the non-overlapping time intervals, one of the sets of stimulation parameter values is selected for the application of the stimulation and the selection is different from the selection for an immediately preceding one of the non-overlapping time intervals. The generated stimulation programs can be used for electrical stimulation of tissue.