Spinal Cord Stimulation Neural Dose Titration for Sub-Perception Therapy

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Solution Overview

Problem

Spinal Cord Stimulation (SCS) therapy often causes paresthesia, and high-frequency sub-perception therapy to avoid paresthesia requires more power, leading to frequent battery replacement or charging, inconveniencing patients.

Innovation Solution

Employing supra-perception stimulation during the sweet spot search to quickly determine effective electrodes, followed by titrating to sub-perception therapy, reducing the wash-in period and optimizing electrode selection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If high-frequency sub-perception therapy is used to avoid paresthesia, then pain relief without paresthesia is achieved, but power consumption increases leading to frequent battery replacement

Engineering Contradiction:
ImproveparesthesiaVSAvoidpower consumption
Core Design Contradiction:
Object-affected harmful factorsVSUse of energy by moving object

Solution Approach 1:

The patent applies parameter changes by varying stimulation frequency and amplitude to achieve sub-perception therapy. The system dynamically adjusts these parameters to provide pain relief while minimizing power consumption, resolving the contradiction between avoiding paresthesia and reducing energy usage.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The system dynamically adapts stimulation parameters based on real-time feedback and patient response. By making the therapy protocol flexible and adjustable, the system optimizes the balance between efficacy (pain relief without paresthesia) and energy consumption, allowing frequent parameter adjustments to achieve optimal performance.

Inventive Principle:
Principle #15Dynamics

2Object-affected harmful factors

If sub-perception therapy is used to avoid paresthesia, then patient comfort is improved, but the wash-in period increases delaying pain relief

Engineering Contradiction:
ImproveparesthesiaVSAvoidwash-in period
Core Design Contradiction:
Object-affected harmful factorsVSLoss of time

Solution Approach 1:

The patent employs preliminary action by first providing supra-perception stimulation during the sweet spot search phase to quickly identify effective electrodes. This preliminary phase accelerates the determination of optimal stimulation parameters, thereby reducing the subsequent wash-in period when transitioning to sub-perception therapy.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system maintains continuous and adaptive stimulation throughout the therapy process. By continuously monitoring patient response and adjusting parameters in real-time, the system ensures uninterrupted pain relief while avoiding the wash-in delay associated with traditional sub-perception therapy initiation.

Inventive Principle:
Principle #20Continuity of useful action

3Measurement precision

If electrode selection is performed using traditional methods, then accurate targeting is achieved, but the process is time-consuming

Engineering Contradiction:
Improveelectrode targeting accuracyVSAvoidsweet spot search duration
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent utilizes feedback mechanisms where the system monitors patient response to stimulation and uses this information to iteratively refine electrode selection. This closed-loop approach accelerates the sweet spot search by providing real-time guidance on effective electrode locations, maintaining high targeting accuracy while significantly reducing search time.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system performs preliminary supra-perception stimulation to rapidly identify candidate electrodes before finalizing the sub-perception therapy protocol. This preliminary electrode selection phase uses higher intensity stimulation to quickly establish effective targeting zones, thereby reducing the overall time required for accurate electrode identification.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS20260000897A1Spinal Cord Stimulation System Determining Optimal Sub-Perception Therapy by Using Neural Dose
Publication Date: 2026.01.01 BOSTON SCI NEUROMODULATION CORP
  • US20260000897A1 patent drawing
  • US20260000897A1 patent drawing
  • US20260000897A1 patent drawing

AI summary

Methods and systems for determining sub-perception stimulation for a patient having a spinal cord stimulator device are disclosed. In one example, an external device includes an algorithm configured to determine a stimulation program for the stimulator device. The algorithm includes a model that comprises pre-determined energy values that cause sub-perception stimulation. The algorithm is configured to determine stimulation parameters for the stimulation program that yield an energy value within the first model. The energy values in the model may be expressed as a function of frequency. The model in particular provides optimal sub-perception stimulation at low frequencies, such as at 1 kHz and below, or even at 400 Hz and below.