Neuromodulation Mode Switching for Paresthesia-Free Therapy

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Solution Overview

Problem

Existing neuromodulation systems face challenges in efficiently transitioning between super-threshold and sub-threshold therapy modes, managing lead migration, and providing seamless energy delivery without paresthesia perception, particularly in implantable devices for chronic pain management.

Innovation Solution

An external control device with programmable modes for neuromodulation systems that allows seamless switching between super-threshold and sub-threshold therapy, automatic adjustment for lead migration, and incremental amplitude changes to maintain therapeutic efficacy without paresthesia.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If the neuromodulation system uses high pulse rates (e.g., greater than 1500 Hz) to provide sub-threshold therapy without paresthesia, then patient comfort is improved, but energy consumption increases

Engineering Contradiction:

Improveparesthesia perceptionVSAvoidenergy consumption

Core Design Contradiction:

Object-affected harmful factorsVSUse of energy by moving object

Solution Approach 1:

The system dynamically adjusts pulse rate based on the selected programming mode. In sub-threshold mode, the pulse rate is increased to greater than 1500 Hz to eliminate paresthesia perception, while in super-threshold mode, the pulse rate is reduced to less than 1500 Hz to conserve energy. This dynamic parameter adjustment resolves the contradiction by adapting the pulse rate to the specific therapeutic requirement.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The system changes the pulse rate parameter between two distinct ranges depending on the programming mode. By switching between low pulse rates (super-threshold) and high pulse rates (sub-threshold), the system achieves both energy efficiency and patient comfort at different times, resolving the inherent trade-off between these two parameters.

Inventive Principle:

Principle #35Parameter changes

2Use of energy by moving object

If the neuromodulation system uses low pulse rates (e.g., less than 1500 Hz) to conserve energy, then energy consumption is reduced, but paresthesia is perceived by the patient

Engineering Contradiction:

Improveenergy consumptionVSAvoidparesthesia perception

Core Design Contradiction:

Use of energy by moving objectVSObject-affected harmful factors

Solution Approach 1:

The system dynamically switches between super-threshold and sub-threshold programming modes based on therapeutic needs. When energy conservation is prioritized, the system operates in super-threshold mode with low pulse rates, accepting paresthesia as a side effect. When patient comfort is prioritized, the system switches to sub-threshold mode with high pulse rates, accepting higher energy consumption. This dynamic mode switching resolves the contradiction.

Inventive Principle:

Principle #15Dynamics

3Adaptability or versatility

If the system transitions between super-threshold and sub-threshold modes using traditional programming methods, then therapy adjustment is possible, but the transition process is complex and time-consuming

Engineering Contradiction:

Improvetherapy mode flexibilityVSAvoidprogramming complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The system pre-configures two distinct programming modes (super-threshold and sub-threshold) with all necessary parameters already optimized for each mode. This preliminary configuration eliminates the need for complex real-time parameter adjustments during mode transitions. The clinician simply selects the desired mode, and the system automatically applies the pre-optimized parameters, reducing programming complexity while maintaining therapy flexibility.

Inventive Principle:

Principle #10Preliminary action

4Reliability

If the neuromodulation device delivers continuous high-amplitude pulses to ensure therapeutic efficacy, then therapy effectiveness is maintained, but patient discomfort increases

Engineering Contradiction:

Improvetherapeutic efficacyVSAvoidpatient discomfort

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system changes the pulse rate parameter to resolve the contradiction between therapeutic efficacy and patient comfort. By delivering high-rate pulses (greater than 1500 Hz) in sub-threshold mode, the system achieves therapeutic effect without causing paresthesia perception. The high pulse rate ensures sufficient neural activation for therapy effectiveness while the sub-threshold amplitude keeps the stimulation below the paresthesia threshold, eliminating patient discomfort.

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS12533516B2Neuromodulation system and method for transitioning between programming modes

Publication Date: 2026.01.27 BOSTON SCI NEUROMODULATION CORP

AI summary

An external control device, neuromodulation system, and method of providing therapy to a patient using an implantable neuromodulator implanted within the patient. Electrical modulation energy is delivered from the neuromodulator to the patient in accordance with the pre-existing modulation program when in one of the super-threshold delivery mode and the sub-threshold delivery mode. Operation of the neuromodulator is switched to the other of the super-threshold delivery mode and the sub-threshold delivery mode. A new modulation program may be derived from a pre-existing modulation program, and the neuromodulator may deliver the electrical modulation energy to the patient in accordance with the pre-existing modulation program during the other of the super-threshold delivery mode and the sub-threshold delivery mode.