Systems and methods for tissue stimulation in medical treatment

• US 10,188,864 B2
• Filed: 07/17/2014
• Issued: 01/29/2019
• 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:
  US14/334,371
• Publication Number:
  US 20140330345A1
• Time in Patent Office: 1,657 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. 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.

Claims

1. A neurostimulation system, comprising:

at least one electrical lead configured for being implanted in a patient and coupled to a plurality of electrical contacts;

a control subsystem having control circuitry configured for;

controlling a stimulation subsystem having stimulation circuitry for generating a plurality of individual partial signals which are electrical pulse trains at one or more pulse rates, and the control circuitry is configured for instructing a modulation output circuitry to repeatedly generate the plurality of individual electrical pulse trains that result in a vector field having a bursting pattern;

routing the pulse trains from the stimulation circuitry to the plurality of electrical contacts; and

,

concurrently conveying each of the plurality of electrical pulse trains respectively to at least one of the plurality of electrical contacts in a manner that allows a combined vector electrical pulse train to be characterized by a pulse rate for at least a portion of the vector electrical pulse train that is equal to or greater than twice the frequency of the individual pulse trains,

wherein at least one electrical pulse train has a frequency of between 1 kHz and 100 kHz.

2. The neurostimulation system of claim 1, wherein an average pulse rate of the individual partial signals is insufficient to produce nerve blockage without an unwanted side effect and an average pulse rate of the vector electrical pulse train is sufficient to produce nerve blockage of a target tissue area without a side effect.

3. The neurostimulation system of claim 1, wherein at least two of the individual partial signals provide stimulation in a non-burst manner and at a time lag that is defined so that the vector electrical pulse train has at least a portion which provides stimulation characterized by bursting.

4. The neurostimulation system of claim 1, wherein at least two of the individual partial signals provide stimulation in a non-burst manner and at a time lag that is defined so that the vector electrical pulse train has at least a portion which provides stimulation characterized by repetitive bursting.

5. The neurostimulation system of claim 1, wherein the stimulation subsystem is configured so that the combined electrical pulse train vector at the common electrical terminal is anodic.

6. The neurostimulation system of claim 1, wherein at least two of the plurality of pulse trains have pulse rates that are identical to each other.

7. The neurostimulation system of claim 1, wherein at least two of the plurality of pulse trains have pulse rates that are different from each other.

8. The neurostimulation system of claim 1, wherein the stimulation subsystem comprises a single programmable signal generator for generating the plurality of electrical pulse trains.

9. The neurostimulation system of claim 1, wherein the modulation output circuitry comprises a plurality of programmable signal generators for respectively generating the plurality of electrical pulse trains.

10. The neurostimulation system of claim 1, further comprising an external patient programmer which is a user interface configured for receiving an input from a user, wherein the control circuitry is configured for selecting and displaying the characteristics selected from the group of:

two or more stimulation fields of the partial signals, and the vector field.

11. The neurostimulation system of claim 1 wherein the plurality of individual partial signals which are electrical pulse trains at one or more pulse rates are subthreshold with respect to a target tissue area, but combine to a vector field that is above threshold at the target tissue area.

12. The neurostimulation system of claim 1 wherein a plurality of individual partial signals which are electrical pulse trains at one or more pulse rates are above threshold with respect a target tissue area, and also combine to a vector field that is above threshold at the target tissue area.

13. The neurostimulation system of claim 1, wherein the stimulation subsystem is configured for generating at least two of the plurality of individual electrical pulse train partial signals in accordance with a parameter that comprises one of a pulse amplitude, pulse duration, and pulse shape.

14. The neurostimulation system of claim 1, wherein the at least one pulse train having a frequency of between 1 kHz and 100 kHz is selected from a database having sets of partial signals found to provide improved transmission through tissue and to avoid at least one unwanted side-effect.

15. The neurostimulation system of claim 1, wherein the control subsystem is configured for operating the stimulation subsystem, such that the pulses of at least two of the plurality of individual electrical pulse train partial signals combine in a vector signal that has at least one individual pulse with a shape that is different from at least one pule of the at least two of the plurality of individual electrical pulse train partial signals.

16. The neurostimulation system of claim 1, wherein the control subsystem is configured for operating the stimulation subsystem, such that the pulses of at least two of the plurality of individual electrical pulse train partial signals vary over a period of time but combine in a vector signal that is approximately the same during that same period of time.

17. The neurostimulation system of claim 1, wherein the stimulation subsystem is configured so that the combined electrical pulse train vector at the common electrical terminal is cathodic.

18. The neurostimulation system of claim 1, wherein an average pulse rate of the individual partial signals is insufficient to produce nerve blockage while an average pulse rate of the vector electrical pulse train is sufficient to produce nerve blockage.

19. A neurostimulation system, comprising:

at least one electrical lead configured for being implanted in a patient and coupled to a plurality of electrical contacts;

a control subsystem having control circuitry configured for;

controlling a stimulation subsystem having stimulation circuitry for generating a plurality of individual partial signals which are electrical pulse trains at one or more pulse rates;

routing the pulse trains from the stimulation circuitry to the plurality of electrical contacts; and

,

concurrently conveying each of the plurality of electrical pulse trains respectively to at least one of the plurality of electrical contacts in a manner that allows a combined vector electrical pulse train to be characterized by a pulse rate for at least a portion of the vector electrical pulse train that is equal to or greater than twice the frequency of the individual pulse trains,

wherein at least one electrical pulse train has a frequency of between 2 kHz and 6 kHz.