Apparatus for peripheral or spinal stimulation
Provided herein are methods of treating a patient comprising providing a medical apparatus comprising an external system and an implantable system, implanting the implantable system, and delivering at least one of power or data to the implantable system with the external system. The external system comprises: at least one external antenna configured to transmit a first transmission signal to the implantable system; an external transmitter configured to drive the at least one external antenna; an external power supply; and an external controller. The implantable system comprises: at least one implantable antenna configured to receive the first transmission signal from the first external device; an implantable receiver; at least one implantable functional element configured to interface with the patient; an implantable controller; an implantable energy storage assembly; and an implantable housing surrounding at least the implantable controller and the implantable receiver. Medical apparatus are also provided.
1 . A method of treating a patient, the method comprising:
transmitting a power signal from an external system to an implantable system, the implantable system comprising one or more functional elements;
producing a stimulation signal via the implantable system, wherein the stimulation signal comprises a mix of a high frequency signal and a low frequency signal, and wherein the stimulation signal is unaffected by changes to the power signal; and
delivering the stimulation signal to the patient via the one or more functional elements while receiving the power signal from the external system, wherein the high frequency signal has a frequency of 1 kHz or higher and the low frequency signal has a frequency of below 1 kHz, the high frequency signal treats pain of the patient, the low frequency signal stimulates motor nerves of the patient, and the high and low frequency signals are delivered together.
2 . The method of claim 1 , wherein the implantable system comprises a controller configured to control the one or more functional elements, and wherein the stimulation signal is produced by the controller.
3 . The method of claim 2 , wherein the controller is configured to control the one or more parameters of the stimulation signal, the one or more parameters selected from the group consisting of: a voltage amplitude; a current amplitude; a frequency; a pulse width; an inter-pulse interval; an amplitude modulation parameter; a frequency modulation parameter; a voltage; a current; a pulse shape; a duty cycle frequency; a duty cycle pulse width; a polarity; a drive impedance; and combinations thereof.
4 . The method of claim 2 , wherein the controller is configured to control a parameter of the implantable system selected from the group consisting of: an anode configuration; a cathode configuration; an energy storage capacity; and combinations thereof.
5 . The method of claim 1 , wherein the one or more functional elements comprise an array of electrodes.
6 . The method of claim 5 , further comprising utilizing one or more of field steering or current steering via the array of electrodes to stimulate target tissue without affecting non-target tissue.
7 . The method of claim 1 , further comprising delivering electrical energy at a frequency below 1 kHz via at least one of the one or more functional elements during a trialing procedure.
8 . The method of claim 1 , further comprising implanting the one or more functional elements at least partially with an epidural space of the patient.
9 . The method of claim 1 , wherein delivering the stimulation signal provides spinal cord stimulation to the patient.
10 . The method of claim 1 , wherein the stimulation signal comprises a duty cycle of between 0.1% and 25%.
11 . The method of claim 1 , wherein the stimulation signal comprises a duty cycle of between 1% and 10%.
12 . The method of claim 1 , wherein the stimulation signal is a first stimulation signal, the method further comprising producing a second stimulation signal comprising a modulation of the high frequency signal with the low frequency signal.
13 . The method of claim 12 , wherein the modulation of the high frequency signal with the low frequency signal comprises a frequency component between 1 kHz and 20 kHz.
14 . The method of claim 12 , wherein for the modulation of the high frequency signal with the low frequency signal, the high frequency signal is modulated via one or more of frequency modulation, amplitude modulation, phase modulation, and pulse width modulation.
15 . The method of claim 12 , wherein the second stimulation signal comprises a plurality of high frequency signals modulated with a plurality of low frequency signals.
16 . The method of claim 1 , wherein the low frequency signal comprises one or more signals between 1 Hz and 1000 Hz, and wherein the high frequency signal comprises one or more signals between 1 kHz and 50 kHz.
17 . The method of claim 1 , wherein the stimulation signal comprises a train of high frequency signals and bursts of low frequency signals.
18 . The method of claim 1 , wherein the stimulation signal comprises a train of low frequency signals and bursts of high frequency signals.
19 . The method of claim 1 , wherein the stimulation signal comprises a pseudo random binary sequence non-return to zero or return to zero waveform.
20 . The method of claim 1 , wherein the stimulation signal comprises pulses comprising one or more of a fixed pulse duration or a fixed frequency.
21 . The method of claim 1 , wherein the stimulation signal comprises pulses comprising one or more of a time-varying pulse duration or a time-varying frequency.
22 . The method of claim 1 , wherein the stimulation signal comprises one or more waveforms selected from the group consisting of: a square wave; a sine wave; a sawtooth; a triangle wave; a trapezoidal wave; a ramp; a waveform with exponential increase; a waveform with exponential decrease; a pulse shape which minimizes power consumption; a Gaussian pulse shape; a pulse train; a root-raised cosine; a bipolar pulse; and combinations thereof.
23 . The method of claim 22 , wherein the stimulation signal comprises a plurality of the one or more waveforms and wherein the stimulation signal cycles among the plurality of waveforms at one or more specified time intervals.
24 . The method of claim 1 , wherein the implantable system further comprises an antenna positioned within a housing.
25 . The method of claim 1 , wherein the implantable system further comprises a housing comprising a major axis less than or equal to 20 mm in length.
26 . The method of claim 1 , wherein the implantable system further comprises a housing comprising a minor axis with a length less than or equal to 8 mm.
27 . The method of claim 1 , wherein the power signal is modulated with-data.
28 . The method of claim 1 , wherein the one or more functional elements comprise one or more first functional elements of a first device of the implantable system, and wherein the implantable system further comprises a second device with one or more second functional elements.
29 . The method of claim 1 , wherein the stimulation signal is delivered to the one or more functional elements via an energy storage assembly of the implantable system.
30 . The method of claim 1 , further comprising rectifying the power signal, wherein the stimulation signal is produced from the rectified power signal.
31 . The method of claim 1 , further comprising transmitting data from the external system to the implantable system to adjust the stimulation signal.
32 . The method of claim 31 , further comprising transmitting an identification code prior to adjusting the stimulation signal to optimize operation of the implantable device in the presence of interference.
33 . The method of claim 1 , wherein the power signal comprises one or more first parameters and the stimulation signal comprises one or more second, different parameters.
34 . The method of claim 33 , wherein the first parameters comprise one or more of a first amplitude, a first frequency, or a first duty cycle, and the second parameters comprise one or more of a second amplitude, a second frequency, or a second duty cycle.