TRANSCUTANEOUS NEUROSTIMULATOR FOR TREATING HYPERTENSION

• US 20110082515A1
• Filed: 12/15/2010
• Published: 04/07/2011
• Est. Priority Date: 10/11/2006
• Status: Active Grant

• Current Assignee: Andrew P. Kramer, Anthony V. Caparso, Imad Libbus
• Original Assignee: Andrew P. Kramer, Anthony V. Caparso, Imad Libbus
• Inventors: Kramer, Andrew P., Libbus, Imad, Caparso, Anthony V.
• Granted Patent: US 8,396,556 B2
• Time in Patent Office: Days
• US Class Current: 607/44
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: Y10S 128/907 Acupuncture

Abstract

A neurostimulation device includes an external neurostimulator worn by a patient using a bracing element that braces a portion of the patient'"'"'s body. The external neurostimulator delivers neurostimulation to modulate a cardiovascular function of the patient. In one embodiment, the external stimulator delivers the neurostimulation transcutaneously to a stimulation target in the patient'"'"'s body using surface stimulation electrodes placed on the body approximately over the stimulation target.

Claims

1. A method for treating hypertension in a patient, comprising:

holding an external neurostimulator on a body surface of the patient using a bracing element configured to brace a portion of the body;

placing surface stimulation electrodes on the body, including placing at least one of the surface stimulation electrodes on an acupuncture point;

executing a stimulation algorithm to transcutaneously deliver neurostimulation from the external neural stimulator to the acupuncture point to treat hypertension, wherein the stimulation algorithm includes parameters selected to modulate cardiovascular function to treat hypertension; and

timing the delivery of the neurostimulation according to a programmed schedule using a clock of the external neurostimulator.

2. The method of claim 1, wherein delivering the neurostimulation comprises delivering electrical neurostimulation pulses at a stimulation frequency between approximately 1 to 5 Hz.

3. The method of claim 2, wherein delivering the neurostimulation comprises delivering the electrical neurostimulation pulses for approximately 0.5 to 24 hours each day.

4. The method of claim 1, further comprising sensing a feedback control signal, and wherein executing the stimulation algorithm to transcutaneously deliver neurostimulation comprises using the feedback control signal to control delivery of the neurostimulation.

5. The method of claim 4, wherein sensing the feedback control signal comprising sensing the feedback control signal using an implantable medical device.

6. The method of claim 1, wherein placing the at least one of the surface stimulation electrodes on the acupuncture point comprises placing one or more of the surface stimulation electrodes on the GB-34 on the Gall Bladder Meridian.

7. The method of claim 1, wherein placing the at least one of the surface stimulation electrodes on the acupuncture point comprises placing one or more of the surface stimulation electrodes on the PC-2 through PC-9 on the Pericardium Meridian.

8. The method of claim 1, wherein placing the at least one of the surface stimulation electrodes on the acupuncture point comprises placing one or more of the surface stimulation electrodes on the HT-7 on the Heart Meridian.

9. The method of claim 1, wherein placing the at least one of the surface stimulation electrodes on the acupuncture point comprises placing one or more of the surface stimulation electrodes on the BL-14 and BL-16 on the Bladder Meridian.

10. The method of claim 1, wherein placing the at least one of the surface stimulation electrodes on the acupuncture point comprises placing one or more of the surface stimulation electrodes on the GV-11 on the Governing Vessel Meridian.

11. The method of claim 1, wherein placing the surface stimulation electrodes comprises placing at least one of the surface stimulation electrodes on the body over a nerve of the autonomic nervous system that modulates the cardiovascular function.

12. The method of claim 1, comprising generating an alarm signal as a reminder of the timed delivery of the neurostimulation.

13. A hypertension therapy system for modulating blood pressure in a body, the system comprising:

a transcutaneous neurostimulation device configured to be worn on the body, the transcutaneous neurostimulation device including;

surface stimulation electrodes configured to be placed on surface of the body;

an external neurostimulator configured to deliver neurostimulation transcutaneously to a stimulation target in the body through the surface stimulation electrodes, the external neurostimulator including;

a stimulation output circuit electrically coupled to the surface stimulation electrodes and configured to deliver the neurostimulation;

a memory circuit;

a stimulation algorithm for delivering a hypertension therapy stored in the memory circuit, the stimulation algorithm including parameters selected to therapeutically modulate blood pressure to treat hypertension;

a stimulation controller coupled to the stimulation output circuit and the memory circuit and configured to control the delivery of the neurostimulation by executing the stimulation algorithm, the stimulation controller including a clock configured to start the delivery of the neurostimulation according to a programmed schedule; and

a chassis housing at least the stimulation output circuit, the memory circuit, and the stimulation controller, wherein at least a first electrode of the surface stimulation electrodes is incorporated onto the chassis; and

a bracing element coupled to the external neurostimulator, the bracing element configured to brace a portion of the body to hold the external neurostimulator on a surface location of the body; and

a portable user communication device including a communicator communicatively coupled to the external neurostimulator via telemetry, the communicator including a user interface.

14. The system of claim 13, wherein the memory circuit is configured to store a history of the delivery of the neurostimulation by the external neurostimulator.

15. The system of claim 13, wherein the stimulation controller comprises a feedback controller configured to control the delivery of the neurostimulation using a feedback control signal, and the external stimulator comprises an external sensor electrically coupled to the feedback controller and configured to sense the feedback control signal.

16. The system of claim 13, wherein the user interface comprises a user input device and a presentation device.

17. The system of claim 16, wherein the presentation device comprises a display configured to present one or more of an on/off status of the external neurostimulator, time, and battery status.

18. The system of claim 17, wherein the external neurostimulator comprises an external sensor configured to sense one or more of a heart rate and a blood pressure, and the display is further configured to present one or more of the heart rate and the blood pressure.

19. The system of claim 13, wherein the external neurostimulator comprises a rechargeable battery.

20. The system of claim 13, wherein the bracing element comprises one or more of a belt having an adjustable length and a sleeve having an adjustable length.

21. The system of claim 13, wherein the bracing element configured to brace a portion of the body to hold the external neurostimulator on the surface location of the body such that the first electrode is approximately on an acupuncture point at which electrical stimulation is known to have anti-hypertensive effects.

22. The system of claim 21, wherein the bracing element is configured to hold the first electrode approximately on an acupuncture point.

23. The system of claim 21, wherein the bracing element is configured to hold the first electrode approximately on the GB-34 acupuncture point of the Gall Bladder Meridian of the body.

24. The system of claim 13, wherein the stimulation controller comprises an alarm signal generator configured to generate an alarm signal as a reminder of the timed delivery of the neurostimulation.

25. The system of claim 13, wherein the clock is configured to start the delivery of the neurostimulation according to a programmed periodic dose for each predetermined period, the periodic dose being a time interval during which the body is treated with the neurostimulation.