Neuromodulation using energy-efficient waveforms

• US 8,805,515 B2
• Filed: 04/11/2013
• Issued: 08/12/2014
• Est. Priority Date: 06/05/2009
• Status: Active Grant

• Current Assignee: IntElect Medical, Inc. (Boston Scientific Corporation)
• Original Assignee: IntElect Medical, Inc. (Boston Scientific Corporation)
• Inventors: York, Randall, Kokones, Scott, Carlton, Keith, Greszler, Alan
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US13/860,686
• Publication Number:
  US 20130238059A1
• Time in Patent Office: 488 Days
• Field of Search: 607/2, 607/45, 607/68, 607/71
• US Class Current: 607/45
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36103 Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
• CPC Class Codes: A61N 1/3615 Intensity

Abstract

Methods of neuromodulation in a live mammalian subject, such as a human patient. The method comprises applying an electrical signal to a target site in the nervous system, such as the brain, where the electrical signal comprises a series of pulses. The pulses includes a waveform shape that is more energy-efficient as compared to a corresponding rectangular waveform. Non-limiting examples of such energy-efficient waveforms include linear increasing, linear decreasing, exponential increasing, exponential decreasing, and Gaussian waveforms. Also described are apparatuses for neuromodulation and software for operating such apparatuses.

Claims

1. A neuromodulation method comprising:

applying an electrical signal to an anatomical site, wherein;

the electrical signal comprises a first phase and a second phase immediately following the first phase;

the electrical signal is anodic in one of the first and second phases and cathodic in the other of the first and second phases; and

a waveform of the electrical signal in each of the first and second phases is entirely defined by one of an exponential increasing function and an exponential decreasing function.

2. The neuromodulation method of claim 1, wherein the waveforms of the electrical signal in the first and second phases are substantially mirror images of each other.

3. The neuromodulation method of claim 1, wherein the waveform represents current amplitude of the signal over time.

4. The neuromodulation method of claim 1, wherein the waveform represents voltage amplitude of the signal over time.

5. The neuromodulation method of claim 1, wherein the anatomical site is a brain site.

6. The neuromodulation method of claim 5, wherein the brain site is involved in motor function.

7. The neuromodulation method of claim 5, wherein the brain site is the thalamus or subthalamic nucleus.

9. The method of claim 7, wherein:

the program-defined function is

10. The method of claim 7, wherein:

the program-defined function is

11. The method of claim 10, wherein σ

is set to 0.05/W.

8. A neuromodulation method comprising:

executing, by an electrical signal generator, a program defining a function to produce an electrical stimulation signal whose waveform corresponds to the program-defined function, wherein the function is one of an exponential increasing function, an exponential decreasing function, and a Gaussian function.

12. A neuromodulation method comprising:

applying an electrical signal to an anatomical site, the electrical signal including a cathodic pulse and an anodic pulse, wherein a peak amplitude of the anodic pulse is less than a peak amplitude of the cathodic pulse.

13. The method of claim 12, wherein a pulse with of the anodic pulse is larger than a pulse width of the cathodic pulse.

14. The method of claim 13, wherein a waveform of the cathodic pulse is one of linear increasing, linear decreasing, exponential increasing, exponential decreasing, rectified sine, and Gaussian.

15. The method of claim 12, wherein a waveform of the cathodic pulse is one of linear increasing, linear decreasing, exponential increasing, exponential decreasing, rectified sine, and Gaussian.

16. The method of claim 12, wherein a waveform of the cathodic pulse is half of a sine wave whose frequency is twice the pulse width of the cathodic pulse.

17. A neuromodulation method comprising:

in a stimulation session, electrically stimulating an anatomical site by executing a stimulation program that defines for the stimulation session one or more waveforms of electrical stimulation signals by one, and not the other, of a linear increasing function and a linear decreasing function.

18. A neuromodulation method comprising:

applying an electrical signal to an anatomical site, wherein a waveform of the electrical signal includes one of (a) a sharp increase to a maximum amplitude of the signal followed by a gradual decrease of the amplitude and (b) a gradual increase to the maximum amplitude followed by a sharp decrease of the amplitude.

19. The neuromodulation method of claim 18, wherein the waveform includes the sharp increase followed by the gradual decrease, and the gradual decrease is defined by an exponentially decreasing function.

20. The neuromodulation method of claim 18, wherein the waveform includes the gradual increase followed by the sharp decrease, and the gradual increase is defined by an exponentially increasing function.

21. A neuromodulation apparatus comprising:

an electrode comprising an electrode contact; and

implantable pulse generator coupled to the electrode and including a processor and a storage medium in which is stored a program which, when executed, causes the processor to generate an electrical signal using the electrode and for stimulating an anatomical site, wherein at least one of;

(a) the generation of the electrical signal is in accordance with a waveform function defined in the program, the function being one of an exponential increasing function, an exponential decreasing function, and a Gaussian function;

(b) the electrical signal includes a cathodic pulse and an anodic pulse, a peak amplitude of the anodic pulse being less than a peak amplitude of the cathodic pulse;

(c) the generation of the signal is in a stimulation session, the program defining for the stimulation session one or more waveforms of electrical stimulation signals by one, and not the other, of a linear increasing function and a linear decreasing function;

(d) a waveform of the electrical signal includes one of (i) a sharp increase to a maximum amplitude of the signal followed by a gradual decrease of the amplitude and (ii) a gradual increase to the maximum amplitude followed by a sharp decrease of the amplitude; and

(e) the electrical signal;

comprises a first phase and a second phase immediately following the first phase;

is anodic in one of the first and second phases and cathodic in the other of the first and second phases; and

is, in each of the first and second phases, of a respective waveform entirely defined by one of the exponential increasing function and the exponential decreasing function.

22. A non-transitory computer-readable medium on which is stored a program executable by a processor, the program which, when executed by the processor, causes the processor to perform a neuromodulation method, the method comprising:

generating an electrical signal using an implanted electrode and for stimulating an anatomical site, wherein at least one of;

(a) the generation of the electrical signal is in accordance with a waveform function defined in the program, the function being one of an exponential increasing function, an exponential decreasing function, and a Gaussian function;

(b) the electrical signal includes a cathodic pulse and an anodic pulse, a peak amplitude of the anodic pulse being less than a peak amplitude of the cathodic pulse;

(c) the generation of the signal is in a stimulation session, the program defining for the stimulation session one or more waveforms of electrical stimulation signals by one, and not the other, of a linear increasing function and a linear decreasing function;

(d) a waveform of the electrical signal includes one of (i) a sharp increase to a maximum amplitude of the signal followed by a gradual decrease of the amplitude and (ii) a gradual increase to the maximum amplitude followed by a sharp decrease of the amplitude; and

(e) the electrical signal;

comprises a first phase and a second phase immediately following the first phase;

is anodic in one of the first and second phases and cathodic in the other of the first and second phases; and

is, in each of the first and second phases, of a respective waveform entirely defined by one of the exponential increasing function and the exponential decreasing function.