High Frequency Spinal Cord Stimulation for Paresthesia-Free Therapy
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Solution Overview
Problem
Conventional spinal cord stimulation systems rely on paresthesia to mask pain, which can be uncomfortable and require lengthy trial periods to determine effective electrode configurations, making them inefficient and burdensome for both patients and practitioners.
Innovation Solution
The development of high frequency spinal cord stimulation systems that deliver therapy without paresthesia, allowing for simultaneous activation of multiple electrodes with an external signal generator to identify responders and reduce the number of active electrodes post-implantation, thereby simplifying the deployment process and reducing trial time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional low frequency SCS is used to generate paresthesia for pain masking, then pain relief is achieved, but patient comfort deteriorates due to uncomfortable tingling sensations and lengthy trial periods are required
Solution Approach 1:
The patent changes the fundamental parameter of stimulation frequency from conventional low frequency (generating paresthesia) to high frequency (paresthesia-free), thereby eliminating patient discomfort while maintaining pain relief effectiveness through different physiological mechanisms
2Productivity
If multiple electrodes are activated simultaneously in high frequency SCS, then deployment time is reduced and testing can be done outside clinic, but power consumption increases
Solution Approach 1:
The patent performs preliminary identification of responder patients and electrode configuration outside the clinic using high frequency stimulation, allowing the implanted device to be pre-programmed with optimal parameters, thereby reducing in-clinic time and enabling efficient deployment while managing power consumption through targeted electrode activation
3Object-affected harmful factors
If high frequency SCS is used without paresthesia, then side effects are minimized, but identification of patient responders becomes more difficult
Solution Approach 1:
The patent establishes feedback mechanisms where patients report pain relief responses during high frequency SCS trials, and practitioners monitor physiological parameters and patient behavior changes to identify responders, compensating for the absence of paresthesia feedback with alternative assessment methods
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach enables efficient identification of responders and optimal electrode configuration, reducing the time and cost of deployment, minimizing side effects, and extending the battery life of the implanted stimulator, while allowing for extended testing outside the clinic.
Implementation Method 1
the signal generator applies electrical pulses to the electrodes, which in turn modify the function of the patient's nervous system
Data Source
AI summary
Methods for identifying responders to paresthesia-free stimulation therapy, and associated systems are disclosed. A representative method comprises implanting a pair of spinal cord signal delivery devices and connecting an external signal generator thereto. A plurality of the electrical contacts are simultaneously activated with a high frequency signal without causing paresthesia in the patient, wherein the electrical contacts would cause paresthesia in the patient if activated with a low frequency signal. The high frequency signal is in a range of from about 3 kHz to about 20 kHz and an amplitude of less than 4 mA. If the patient responds favorably, a signal generator is implanted in the patient. A second high frequency signal is then applied to fewer than the plurality of electrical contacts.