Multi-Modality Spinal Cord Stimulation With Paresthesia Feedback
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Solution Overview
Problem
Existing spinal cord stimulation therapies for neuropathic pain lack intuitive patient control and self-titration, with paresthesia-based and paresthesia-free methods requiring complex adjustments and providing inconsistent or delayed pain relief, leading to sub-optimal efficacy and frequent device failures.
Innovation Solution
A device and method combining high and low frequency pulse trains, allowing patients to experience direct feedback through paresthesia sensations for adjusting therapy strength, using a single therapy strength setting to optimize both pain relief mechanisms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If paresthesia-free high frequency stimulation is used, then patient comfort is improved by eliminating paresthesia sensations, but patient control and titration capability are worsened due to lack of immediate feedback
Solution Approach 1:
The device merges paresthesia-free high frequency stimulation with paresthesia-based low frequency stimulation into a single programmable system. The pulse generator can deliver both stimulation types through the same electrode leads, allowing clinicians to select and switch between modalities based on patient needs and feedback responses.
Solution Approach 2:
The stimulation system is made dynamically adjustable with multiple programmable parameters including frequency, pulse width, and amplitude. The device allows real-time modification of stimulation characteristics and can switch between different stimulation programs, enabling adaptive titration based on patient response while maintaining comfort.
2Ease of operation
If paresthesia-based low frequency stimulation is used, then patient control through paresthesia feedback is improved, but long-term efficacy is worsened due to tolerance development and loss of efficacy over time
Solution Approach 1:
The system employs periodic switching between paresthesia-based and paresthesia-free stimulation modalities. By alternating between low frequency paresthesia-inducing stimulation and high frequency paresthesia-free stimulation, the device prevents tolerance development while maintaining patient control through intermittent feedback.
Solution Approach 2:
The device utilizes parameter changes by varying stimulation frequency, pulse width, and amplitude to switch between therapeutic modalities. This allows the system to adapt to changing patient needs and prevent tolerance by modifying stimulation characteristics over time while maintaining efficacy.
3Adaptability or versatility
If multiple stimulation programs are provided, then therapy versatility is improved, but device complexity and ease of use are worsened due to patient difficulty in selecting and managing multiple programs
Solution Approach 1:
The pulse generator is designed as a universal device capable of delivering multiple stimulation modalities (paresthesia-based, paresthesia-free, and combination therapies) through the same hardware platform. This multi-functionality is achieved through programmable parameters rather than separate dedicated devices, maintaining ease of use while providing versatility.
4Reliability
If high amplitude stimulation is used to ensure pain relief, then pain relief efficacy is improved, but energy consumption is worsened leading to more frequent recharging
Solution Approach 1:
The device optimizes energy consumption by dynamically adjusting stimulation parameters (amplitude, pulse width, frequency) based on the selected therapy program and patient response. The system uses the lowest effective amplitude required for pain relief, and can switch between paresthesia-based and paresthesia-free modalities to manage energy usage while maintaining efficacy.
Data Source
AI summary
A device for neurostimulation includes a pulse generator for generating current having pulses and at least one first pair of electrodes connected to the pulse generator. The device provides a user-programmable therapy strength parameter configuration and at least two current parameter configurations for neurostimulation stored in the pulse generator. The current parameter configurations are controlled by the therapy strength configuration, at least one of the current parameter configurations is associated with a level of paresthesia sensation of a patient and at least one of the current parameter configurations is associated with a paresthesia-free therapy for the patient. The association between therapy strength parameter and current parameter configurations uniquely adjusts the current parameter configurations based on paresthesia or paresthesia-free intent, when neurostimulation is performed using parameter configurations. Particularly, the current parameter configurations include parameters such as pulse trains, pulse frequencies, duty cycling, and amplitudes of the current.