Neuromodulation device and method for use

Inventors

IZVORSKI, Alexander B. • RAHIMI, Shaun • McCullough, Kevin

Abstract

Neuromodulation devices and methods of their use are described in which a therapeutic device is configured to generate a treatment for treating pain such as the reduction of the symptoms of chronic and acute pain as well as for treating other conditions. The neuromodulation device generates an output electrical signal in the form of pulses with a fast rise-time spike waveform followed by a longer-duration, lower amplitude primary phase waveform. The output signal includes a broad range of frequency components, with time constants tuned so as to interact with specific cell membrane or cellular components. The output signal may be conducted to the patient via electrodes. The pulses are triggered at variable intervals which prevent habituation.

Core Innovation

The invention relates to a neuromodulation device and methods for treating a tissue region of a living body through electrical neuromodulation. The device includes a pair of electrodes positioned proximate to the tissue region and a controller configured to transmit a pulse waveform through the electrodes. The pulse waveform includes a spike having a first amplitude and a first duration, followed by a primary phase having a second amplitude and a second duration that is longer than the spike duration.

The primary phase includes a second amplitude that is less than the first amplitude, and the waveform then enters a secondary phase. The secondary phase has a third amplitude with polarity opposite to the second amplitude and a third duration that is greater than the second duration. In related method claims, the pulse waveform is caused to enter a primary phase after a spike defined by rise time, hold time, and fall time transitions, and the primary phase includes a fall time transition from the second amplitude to 0 volts.

The secondary phase is also defined with rise, hold, and fall transitions leading to 0 volts. Additional waveform phases include dead time where voltage is at 0 volts for a defined duration, and multi-waveform sequences with alternating direction across successive pulse waveforms are included.

Claims Coverage

The independent claims are 3 in total, focused on a neuromodulation device with a multi-phase pulse waveform, a method with defined spike-to-primary transitions and fall to 0 volts, and a method with spike/primary/secondary phases including transitions to zero. Across these independent claims, the coverage is centered on the pulse waveform phase architecture, phase polarity relationships, and transitions to 0 volts, with further dependent refinements that add quantitative timing constraints and optional dead phase behavior and multi-waveform sequencing.

The independent claims collectively cover a neuromodulation pulse waveform architecture defined by a spike phase transitioning into a primary phase and then into a secondary phase with opposite polarity relative to the primary. The method claims additionally require phase transition structures defined by rise/hold/fall timing and transitions to 0 volts, while the third independent claim defines the spike-to-primary-to-secondary sequence in terms of voltage moving back to zero.

Stated Advantages

Documented Applications