TRANSCUTANEOUS NEUROSTIMULATOR FOR MODULATING CARDIOVASCULAR FUNCTION

• US 20080091256A1
• Filed: 10/11/2006
• Published: 04/17/2008
• Est. Priority Date: 10/11/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers
• Inventors: Kramer, Andrew P., Libbus, Imad, Caparso, Anthony V.
• Granted Patent: US 7,797,041 B2
• Time in Patent Office: Days
• US Class Current: 607/149
• 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 system for transcutaneous neurostimulation to modulate a cardiovascular function 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 adapted to deliver neurostimulation transcutaneously to a stimulation target in the body through the surface stimulation electrodes; 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.

2. The system of claim 1, wherein the external neurostimulator comprises:

a stimulation output circuit electrically coupled to the surface stimulation electrodes, the stimulation output circuit adapted to deliver the neurostimulation;

a stimulation controller coupled to the stimulation output circuit, the stimulation controller adapted to control the delivery of the neurostimulation by executing a stimulation algorithm adapted to modulate the cardiovascular function; and

a memory circuit configured to store the stimulation algorithm including the stimulation parameters.

3. The system of claim 2, wherein the memory circuit is configured to store a history of the delivery of the neurostimulation by the external neurostimulator.

4. The system of claim 2, wherein the stimulation controller comprises a feedback controller adapted to control the delivery of the neurostimulation using a feedback control signal, and further comprising an external sensor, electrically coupled to the feedback controller, to sense the feedback control signal.

5. The system of claim 2, wherein the stimulation controller comprises a feedback controller adapted to control the delivery of the neurostimulation using a feedback control signal, wherein the external neurostimulator comprises a stimulator telemetry circuit adapted to receive the feedback control signal via telemetry, and further comprising an implantable medical device including:

a sensor adapted to sense a physiologic signal;

a sensor processing circuit adapted to produce the feedback control signal using the sensed physiologic signal; and

an implant telemetry circuit adapted to transmit the feedback control signal to the external neurostimulator.

6. The system of claim 2, further comprising a user interface coupled to the stimulation controller, the user interface including a user input device and a presentation device.

7. The system of claim 6, wherein the external neurostimulator comprises the user interface.

8. The system of claim 6, further comprising a portable user communication device including a communicator communicatively coupled to the external neurostimulator via telemetry, the communicator including the user interface.

9. The system of claim 6, wherein the user input device comprises a power switch to turn the external neurostimulator on/off.

10. The system of claim 9, 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.

11. The system of claim 10, wherein the transcutaneous neurostimulation device comprises an external sensor coupled to the external neurostimulator, the external sensor adapted 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.

12. The system of claim 1, wherein the external neurostimulator comprises a rechargeable battery.

13. The system of claim 1, wherein at least one of the stimulation electrodes is incorporated onto the external neurostimulator.

14. The system of claim 13, wherein the bracing element is configured to hold the at least one of the stimulation electrodes on the surface of the body approximately over the stimulation target in the body.

15. The system of claim 13, wherein the bracing element is configured to hold the at least one of the stimulation electrodes approximately on the GB-34 acupuncture point of the Gall Bladder Meridian of the body.

16. 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.

17. The system of claim 16, wherein the bracing element is in a form of a wrist band or sleeve.

18. The system of claim 16, wherein the bracing element is in a form of a knee band or sleeve.

19. A method for modulating a cardiovascular function in a body by transcutaneous neurostimulation, the method comprising:

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

placing surface stimulation electrodes on the body, with at least one of the surface stimulation electrodes placed approximately over a stimulation target in the body;

delivering neurostimulation transcutaneously to the stimulation target from the external neurostimulator through the surface stimulation electrodes; and

controlling the delivery of the neurostimulation by executing a stimulation algorithm adapted to modulate the cardiovascular function.

20. The method of claim 19, wherein delivering the neurostimulation comprises delivering electrical neurostimulation pulses at a stimulation frequency between approximately 1 to 5 Hz.

21. The method of claim 20, wherein delivering the neurostimulation comprises delivering the electrical neurostimulation pulses for approximately 0.5 to 24 hours each day.

22. The method of claim 19, further comprising sensing a feedback control signal, and wherein controlling the delivery of the neurostimulation comprises controlling the delivery of the neurostimulation using the feedback control signal.

23. The method of claim 22, wherein sensing the feedback control signal comprising sensing the feedback control signal using an implantable medical device.

24. The method of claim 19, wherein placing the surface stimulation electrodes comprises placing at least one of the surface stimulation electrodes on an acupuncture point.

25. The method of claim 24, wherein placing the at least one of the surface stimulation electrodes on the acupuncture point comprises placing the at least one of the surface stimulation electrodes on acupuncture point GB-34 on the Gall Bladder Meridian.

26. The method of claim 24, 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 one or more of acupuncture points including:

PC-2 through PC-9 on the Pericardium Meridian;

HT-7 on the Heart Meridian;

BL-14 and BL-16 on the Bladder Meridian; and

GV-11 on the Governing Vessel Meridian.

27. The method of claim 19, 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.