Systems and methods for improved spinal cord stimulation

• US 10,583,299 B2
• Filed: 01/07/2019
• Issued: 03/10/2020
• Est. Priority Date: 01/21/2005
• Status: Active Grant

• Current Assignee: Michael Sasha John
• Original Assignee: Michael Sasha John
• Inventors: John, Michael Sasha
• Primary Examiner(s): Hulbert, Amanda K
• Application Number:
  US16/241,524
• Publication Number:
  US 20190134402A1
• Time in Patent Office: 428 Days
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

Stimulation treatments for various medical disorders, such as neurological disorders, comprise novel systems, strategies, and methods for providing TMS, electrical, magnetic, optical and other stimulation modalities. Some stimulation methods comprise varying the stimulation parameters to improve the therapeutic efficacy of stimulation, and decrease risk of habituation and side-effects such as interference with normal brain, sensory, motor, and cognitive processes. The creation, and subsequent variation, of stimulation parameters can use sensed data in order to match, adjust, or avoid matching characteristics of the stimulation therapy relative to certain endogenous brain activities. Novel methods are described for choosing, creating and subsequently stimulating with partial signals which summate to produce therapeutic vector fields having unique temporal patterns and low- or high-frequency spectral content. Improvements for the treatment of pain are disclosed.

Claims

1. A patient treatment system comprising:

an implantable pulse generator programmed to provide a first pulsed electrical signal having at least one frequency selected within the range of from about 1 kHz to about 100 kHz;

the implantable pulse generator having at least a first implantable electrical lead with a first set of electrical contacts adapted to be located adjacent a patient'"'"'s spinal cord for delivering the first pulsed electrical signal to at least one location along said patient'"'"'s spinal cord to treat pain in the patient through application of the first pulsed electrical signal, the implantable pulse generator further configured to adjust the first pulsed electrical signal amplitude based upon at least one impedance measurement;

the implantable pulse generator being configured to provide the first pulsed electrical signal without the first pulsed electrical signal producing an unwanted side-effect related to sensory processing.

2. The system of claim 1 wherein the first pulsed electrical signal is realized as a modulated carrier signal.

3. The system of claim 1 wherein the first pulsed electrical signal is realized as a modulated carrier signal with a modulation signal selected to avoid producing said unwanted side-effect related to interference of sensory processing.

4. The system of claim 1 wherein the first pulsed electrical signal is further realized as a modulated carrier signal selected to avoid producing an unwanted side-effect related to interference of at least one motor process.

5. The system of claim 1 wherein the implantable pulse generator is programmed to provide the first pulsed electrical signal at the selected frequency being further selected to deter a side-effect related to interference of a motor process.

6. The system of claim 1 wherein the implantable pulse generator is programmed with a stimulation protocol that creates the first pulsed electrical signal with balanced, biphasic, pulses having approximately balanced and opposite current amplitudes.

7. The system of claim 1 wherein the implantable pulse generator is programmed to provide the first pulsed electrical signal at a frequency of from about 2 kHz to about 6 kHz.

8. The system of claim 1 wherein electrical contacts of a stimulator used to provide the pulsed electrical signal are spaced apart from each other by a distance and geometry that is selected or adjusted in relation to an intended superposition of signal components of a vector stimulus waveform.

9. The system of claim 1 wherein the implantable pulse generator is programmed to provide the first pulsed electrical signal at the selected frequency within the range of about 4 kHz to about 100 kHz.

10. The system of claim 1 wherein the implantable pulse generator is programmed to provide the first pulsed electrical signal at the selected frequency, wherein the frequency is selected to increase transmission of the signal through tissue compared to a lower frequency range than the frequency range between 1 kHz and 100 kHz.

11. The system of claim 1 wherein the implantable pulse generator is programmed to modulate the first pulsed electrical signal using a selected modulation frequency within the range of approximately 0.1 Hz to 40 Hz.

12. The system of claim 1, further including a sensing subsystem having at least one sensor positioned to detect a sensed data including an evoked response to the first pulsed electrical signal.

13. The system of claim 1, further including a sensing subsystem having at least one sensor positioned to detect a sensed data including an evoked response to the first pulsed electrical signal, the system configured to adjust a characteristic of the first pulsed electrical signal based upon evaluation of a characteristic of sensed data.

14. The system of claim 1, further including a sensing subsystem having at least one sensor configured to sense sensed data selected from the group of:

temperature, EMG, and combinations thereof, and an evaluation subsystem configured to evaluate the sensed data and adjust at least one stimulation protocol parameter based upon evaluation of the sensed data.

15. The system of claim 1, further including a sensing subsystem having at least one sensor configured to sense sensed data selected from the group of:

acceleration, activity, pressure, or motion and combinations thereof, and an evaluation subsystem configured to evaluate the sensed data and adjust at least one stimulation protocol parameter based upon evaluation of the sensed data.

16. The system of claim 1, further including a sensing subsystem having at least one sensor configured to sense sensed data related to the patient, and an evaluation subsystem configured to evaluate the sensed data and adjust at least one stimulation protocol parameter of a modulation signal based upon evaluation of the sensed data.

17. A patient treatment system, comprising:

a neurostimulator system programmed to provide a first pulsed electrical signal within a frequency range between approximately 1 kHz to approximately 100 kHz;

an implantable pulse generator having at least a first implantable electrical lead with a first set of electrical contacts adapted to be located adjacent a patient'"'"'s spinal cord for delivering the first pulsed electrical signal to at least one location along said a patient'"'"'s spinal cord treat pain in the patient through application of the first pulsed electrical signal, the implantable pulse generator further configured to adjust the first pulsed electrical signal amplitude based upon at least one impedance measurement;

the first pulsed electrical signal configured to treat pain without the first pulsed electrical signal producing an unwanted side-effect related to sensory processing; and

an external device having a communication system to communicate with and control the implantable pulse generator.