Interleaving Stimulation Programs in Implantable Pulse Generators

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Solution Overview

Problem

Current implantable stimulation devices, such as Spinal Cord Stimulation (SCS) systems, face challenges in efficiently delivering customizable electrical stimulation due to uncertainties in electrode placement and changing physiological responses, requiring a trial-and-error approach to find effective stimulation parameters, which can be time-consuming and inefficient.

Innovation Solution

The implementation of a technique that allows for the interleaving of multiple stimulation programs in time, using a time domain allocation method, where the control circuitry of the implantable medical device receives input to specify the duration and mode of operation for each program, enabling seamless transition between programs and optimizing the effectiveness of stimulation therapy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If multiple stimulation programs are delivered sequentially using traditional trial-and-error approach, then customization to individual patient needs is improved, but treatment time and patient discomfort increase

Engineering Contradiction:
Improvecustomization to individual patient needsVSAvoidtreatment time
Core Design Contradiction:
Adaptability or versatilityVSLoss of time

Solution Approach 1:

The patent implements periodic action by rapidly alternating between multiple stimulation programs in a cyclic manner, with each program delivered for a specified duration before switching to the next. This allows the system to cycle through different stimulation patterns (e.g., high-frequency and low-frequency programs) repeatedly within a single treatment session, achieving customization without requiring sequential trial-and-error adjustments that would extend treatment time.

Inventive Principle:
Principle #19Periodic action

2Reliability

If multiple stimulation programs are tested separately to find effective parameters, then stimulation effectiveness is improved, but patient discomfort and procedure complexity increase

Engineering Contradiction:
Improvestimulation effectivenessVSAvoidprocedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges multiple stimulation programs into a single integrated delivery system. The control circuitry combines several pre-programmed stimulation patterns (different frequencies, pulse widths, and electrode configurations) into one unified treatment protocol that automatically alternates between them. This allows the system to test multiple stimulation effectiveness parameters simultaneously rather than requiring separate procedural steps for each program, thereby reducing procedure complexity while maintaining stimulation effectiveness.

Inventive Principle:
Principle #5Merging (Combining)

3Ease of operation

If traditional single-program stimulation is used, then device operation is simple, but adaptability to changing physiological responses is limited

Engineering Contradiction:
Improvedevice operation simplicityVSAvoidadaptability to changing physiological responses
Core Design Contradiction:
Ease of operationVSAdaptability or versatility

Solution Approach 1:

The patent implements dynamics by making the stimulation program selection adaptive rather than static. The control circuitry automatically adjusts which stimulation programs are delivered and for how long based on real-time physiological feedback or pre-programmed criteria. This allows the system to respond to changing physiological conditions (such as varying pain levels or tissue responses) without requiring complex manual reconfiguration, thereby maintaining ease of operation while significantly improving adaptability.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentEP3755430B1Interleaving stimulation patterns provided by an implantable pulse generator
Publication Date: 2024.09.11 BOSTON SCI NEUROMODULATION CORP
  • EP3755430B1 patent drawingFigure 1~2
  • EP3755430B1 patent drawingFigure 3
  • EP3755430B1 patent drawingFigure 4

AI summary

An implantable medical device is configured to receive an input that specifies a time domain allocation between two or more stored stimulation programs and to provide control signals corresponding to each of the two or more stimulation programs to stimulation circuitry to interleave the two or more stimulation programs in time according to the input. The time domain allocation may set a proportion of time during which each of the stimulation programs is active during repeating epochs. The time domain allocation may be set by a user to transition between configured stimulation programs or to specify stimulation that is based on two or more different stimulation programs. The time domain allocation may also be adjusted automatically to optimize an indication of an effectiveness of stimulation that is provided by the patient.