Sub-perception Stimulation Volume Confirmation via Periodic Threshold Switching
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Solution Overview
Problem
Current medical devices face challenges in determining the appropriate stimulation parameters for delivering electrical stimulation therapy below the perception threshold, leading to inefficient energy use and potential unnecessary stimulation, as patients do not perceive the therapy, making it difficult to confirm the therapeutic effect and coverage area.
Innovation Solution
The system employs a dual therapy approach, with a first stimulation therapy delivered below the perception threshold and a second stimulation therapy above it, allowing the patient to perceive the effect, thereby confirming the volume of effect and adjusting the intensity automatically to maintain coverage, using a processor to determine and switch between the two therapies based on user input.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of energy
If electrical stimulation therapy is delivered below the perception threshold, then patient discomfort is reduced and energy efficiency is improved, but the ability to confirm therapeutic effect and coverage area is lost
Solution Approach 1:
The system alternates between delivering sub-perception threshold stimulation therapy and delivering perception-threshold stimulation therapy in periodic cycles. During sub-perception phases, energy-efficient therapy is delivered without patient awareness. During perception phases, the patient experiences paresthesia that confirms the coverage area and therapeutic effect. This periodic switching resolves the contradiction by providing both energy efficiency and confirmation capability.
Solution Approach 2:
The perception-threshold stimulation acts as an intermediary tool to indirectly confirm the coverage area of the sub-perception threshold stimulation. By delivering stimulation at perception threshold and having the patient report the paresthesia location, the system can infer the effective coverage area of the lower-intensity sub-perception therapy without actually delivering the higher intensity continuously.
2Object-affected harmful factors
If electrical stimulation therapy is delivered below the perception threshold, then patient discomfort is reduced, but the ability to determine appropriate stimulation parameters is compromised
Solution Approach 1:
The system periodically switches between sub-perception and perception-threshold stimulation modes. During perception modes, the patient experiences and reports paresthesia, providing real-time feedback on stimulation parameters and coverage area. This feedback is used to precisely determine and adjust parameters for the sub-perception therapy mode, ensuring appropriate stimulation while maintaining low discomfort.
Solution Approach 2:
The system incorporates patient feedback during perception-threshold phases to adjust sub-perception threshold parameters. The patient reports the location and characteristics of paresthesia, which serves as feedback to refine the stimulation parameters for the sub-perception mode, ensuring optimal therapeutic effect with minimal discomfort.
3Loss of information
If electrical stimulation therapy is delivered at perception threshold intensity, then the volume of effect can be confirmed, but energy consumption increases and unnecessary stimulation may occur
Solution Approach 1:
The system uses periodic perception-threshold stimulation phases only when confirmation of volume of effect is needed, rather than continuously delivering at high intensity. During sub-perception phases, low energy consumption therapy is delivered. The periodic high-intensity phases provide confirmation data that is then used to optimize future low-intensity therapy, minimizing overall energy consumption while maintaining confirmation capability.
Solution Approach 2:
The system delivers perception-threshold stimulation only partially and temporarily when confirmation is needed, rather than continuously. This partial action provides sufficient volume of effect confirmation without the continuous energy consumption and unnecessary stimulation that would occur with sustained high-intensity delivery.
Data Source
AI summary
A system may include a therapy delivery module configured to deliver electrical stimulation therapy to a tissue of a patient in accordance with a first stimulation therapy program. The first stimulation therapy program may define a first stimulation intensity below a perception threshold stimulation intensity of the patient. The therapy delivery module also may be configured to deliver electrical stimulation therapy to the tissue of the patient in accordance with a second stimulation therapy program. The second stimulation therapy program may define a second stimulation intensity at or above the perception threshold stimulation intensity. The system also may include a processor configured to determine stimulation parameter values for the first stimulation therapy program that result in a first volume of effect and determine stimulation parameter values for the second stimulation therapy program that result in a second volume of effect substantially the same as the first volume of effect.