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 medical apparatus for providing spinal cord stimulation to a patient, the medical apparatus comprising:
(a) an external system configured to transmit one or more transmission signals, each transmission signal comprising at least power or data; and
(b) an implantable system configured to receive the one or more transmission signals from the external system;
wherein the external system comprises a first external device comprising:
(i) at least one external antenna configured to transmit a first transmission signal to the implantable system, the first transmission signal comprising at least power or data;
(ii) an external transmitter configured to drive the at least one external antenna;
(iii) an external power supply configured to provide power to at least the external transmitter; and
(iv) an external controller configured to control the external transmitter; and
wherein the implantable system comprises a first implantable device comprising:
(i) at least one implantable antenna configured to receive the first transmission signal from the first external device;
(ii) an implantable receiver configured to receive the first transmission signal from the at least one implantable antenna;
(iii) at least one implantable functional element configured to be placed at least partially within an epidural space of the patient to interface with the patient;
(iv) an implantable controller configured to control the at least one implantable functional element;
(v) an implantable energy storage assembly configured to provide power to an element selected from the group consisting of: the at least one implantable functional element; the implantable controller; the implantable receiver; and
combinations thereof; and
(vi) an implantable housing surrounding at least the implantable controller and the implantable receiver;
wherein the implantable controller is configured to produce a stimulation signal comprising a mix and/or modulation of a high frequency signal and a low frequency signal,
wherein the high frequency signal is at or above 1 kHz and configured to treat pain of the patient,
wherein the low frequency signal is below 1 kHz and configured to stimulate motor nerve tissue of the patient, and
wherein the implantable controller is operatively coupled to the at least one functional element to deliver the mix and/or modulation of the high frequency signal and the low frequency signal to the patient.
2. The medical apparatus according to claim 1 , wherein the at least one functional element is further configured to deliver electrical energy at frequencies below 1 kHz during a trialing procedure.
3. The medical apparatus according to claim 1 , wherein the at least one functional element comprises an array of electrodes.
4. The medical apparatus according to claim 3 , wherein the array of electrodes is configured to utilize field steering and/or current steering to stimulate target tissue without affecting non-target tissue.
5. The medical apparatus according to claim 4 , wherein the target tissue comprises DRG tissue, and wherein the non-target tissue comprises ventral root tissue.
6. The medical apparatus according to claim 1 , wherein the implantable controller is configured to control a parameter selected from the group consisting of: a direct current (DC) parameter such as amplitude of voltage and/or current; amplitude; frequency; pulse width; inter-pulse interval (e.g. random, varied or constant); an amplitude modulation parameter; a frequency modulation parameter; anode/cathode configuration; voltage; current; pulse shape; a duty cycle parameter such as frequency, pulse width or off time; polarity; drive impedance; energy storage capacity; and combinations thereof.
7. The medical apparatus according to claim 1 , wherein the implantable controller is configured to provide a stimulation signal comprising a duty cycle between 0.1% and 25%.
8. The medical apparatus according to claim 1 , wherein the implantable controller is configured to provide a stimulation signal comprising a duty cycle between 1% and 10%.
9. The medical apparatus according to claim 1 , wherein the implantable controller is configured to provide a frequency modulated stimulation waveform comprising a frequency component between 1 kHz and 20 kHz.
10. The medical apparatus according to 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.
11. The medical apparatus according to claim 1 , wherein the implantable controller is configured to produce a stimulation signal comprising a train of high frequency signals and bursts of low frequency signals.
12. The medical apparatus according to claim 1 , wherein the implantable controller is configured to produce a stimulation signal comprising a train of low frequency signals and bursts of high frequency signals.
13. The medical apparatus according to claim 1 , wherein the implantable controller is configured to produce a stimulation signal comprising one or more high frequency signals modulated with one or more low frequency signals.
14. The medical apparatus according to claim 13 , wherein the implantable controller modulates the high frequency signal via frequency modulation, amplitude modulation, phase modulation, and/or pulse width modulation.
15. The medical apparatus according to claim 1 , wherein the implantable controller is configured to produce a stimulation signal comprising a pseudo random binary sequence non-return to zero or return to zero waveform.
16. The medical apparatus according to claim 15 , wherein the stimulation signal comprises fixed pulse duration and/or fixed frequency of stimulation pulses.
17. The medical apparatus according to claim 15 , wherein the stimulation signal comprises time-varying pulse duration and/or time-varying frequency of stimulation pulses.
18. The medical apparatus according to claim 1 , wherein the at least one implantable functional element is configured to deliver a high frequency alternating current block.
19. The medical apparatus according to claim 1 , wherein the at least one implantable functional element is configured to deliver a stimulation signal comprising a waveform selected from the group consisting of: square wave; sine wave; sawtooth; triangle wave; trapezoidal; ramp; waveform with exponential increase; waveform with exponential decrease; pulse shape which minimizes power consumption; Gaussian pulse shape; pulse train; root-raised cosine; bipolar pulses; and combinations thereof.
20. The medical apparatus according to claim 1 , further comprising a second implantable device comprising: at least one implantable functional element configured to interface with the patient.
21. The medical apparatus according to claim 1 , wherein the at least one implantable functional element is implanted to at least partially surround tissue to be stimulated.
22. The medical apparatus according to claim 1 , wherein the at least one implantable antenna is positioned within the implantable housing.
23. The medical apparatus according to claim 1 , wherein the at least one implantable antenna is positioned outside the implantable housing.
24. The medical apparatus according to claim 1 , wherein the implantable housing comprises a major axis less than or equal to 20 mm in length.
25. The medical apparatus according to claim 1 , wherein the implantable housing comprises a minor axis with a length less than or equal to 8 mm.