PERCUTANEOUS NEUROSTIMULATOR FOR MODULATING CARDIOVASCULAR FUNCTION

• US 20080091248A1
• 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 Incorporated (Boston Scientific Corporation)
• Inventors: Kramer, Andrew P., Libbus, Imad, Caparso, Anthony V.
• Granted Patent: US 7,797,046 B2
• Time in Patent Office: Days
• US Class Current: 607/60
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient

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 neurostimulation percutaneously to a stimulation target in the patient'"'"'s body using at least one percutaneous stimulation electrode having a distal end lodged on or near the stimulation target.

Claims

1. A system for percutaneous neurostimulation to modulate a cardiovascular function in a body, the system comprising:

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

at least one percutaneous stimulation electrode configured to lodge in a stimulation site in the body;

an external neurostimulator adapted to deliver neurostimulation percutaneously to a stimulation target in the body through the at least one percutaneous stimulation electrode, the external neurostimulator including;

a stimulation output circuit electrically coupled to the at least one percutaneous stimulation electrode, the stimulation output circuit adapted to deliver the neurostimulation; and

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.

2. The system of claim 1, wherein the external neurostimulator comprises a memory circuit configured to store the stimulation and a history of the delivery of the neurostimulation by the external neurostimulator.

7. The system of claim 1, further comprising a user interface coupled to the stimulation controller, the user interface including a user input device and a presentation device.

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

9. The system of claim 7, further comprising a portable user communication device including a communicator communicatively coupled to the external neurostimulator via telemetry, the communicator including the user interface.

10. The system of claim 7, wherein the user input device comprises a power switch to turn the external neurostimulator on/off.

11. The system of claim 10, 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.

12. The system of claim 11, wherein the percutaneous 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.

13. The system of claim 1, wherein the percutenous neurostimulation device comprises a button and a lead, the button electrically connected to the at least one percutaneous stimulation electrode and configured to be mounted on a surface location of the body, the lead electrically connected between the external neurostimulator and a connector configured to allow snap-on connection to the button.

14. The system of claim 1, wherein the at least one percutaneous electrode comprises a wire electrode including a wire having a proximal end electrically coupled to the external neurostimulator and a distal end configured to lodge in the stimulation site in the body.

15. The system of claim 14, wherein the wire electrode comprises a needle electrode, and the wire is substantially rigid.

16. The system of claim 14, wherein the wire electrode comprises a flexible electrode, and the wire is substantially flexible.

17. The system of claim 14, wherein the distal end of the wire comprises a hook or barbs.

18. The system of claim 1, wherein the percutaneous neurostimulation device comprises a lead and an implantable capsule having opposite ends, and the at least one percutaneous electrode is incorporated into one of the opposite ends and electrically connected to the external neurostimulator through the lead.

19. The system of claim 18, wherein the implantable capsule is configured to be implanted into the body by injection using a hollow needle or catheter.

20. The system of claim 18, wherein the percutaneous neurostimulation device comprises a magnet coupled to the lead and configured to be attached onto a surface portion of the body over the capsule to prevent the capsule from drifting in the body.

21. The system of claim 1, wherein the percutaneous neurostimulation device comprises a surface stimulation electrode configured to be placed on surface of the body, and the external neurostimulator is adapted to deliver neurostimulation percutaneously to the stimulation target in the body through the at least one percutaneous stimulation electrode and the surface stimulation electrode.

3. The system of clam 1, wherein the percutenous neurostimulation device comprises 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.

4. The system of claim 3, wherein the bracing element comprises one or more of a belt having an adjustable length and a sleeve having an adjustable length.

5. The system of claim 3, 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.

6. The system of claim 3, 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.

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

delivering neurostimulation percutaneously to a stimulation target in the body through at least one percutaneous stimulation electrode lodged in the body on or about the stimulation target; and

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

23. The method of claim 22, wherein delivering the neurostimulation comprises delivering electrical neurostimulation pulses at a stimulation frequency between approximately 1 to 50 Hz.

24. The method of claim 23, wherein delivering the neurostimulation comprises delivering the electrical neurostimulation pulses for approximately 0.5 to 24 hours each day.

25. The method of claim 22, 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.

26. The method of claim 25, wherein sensing the feedback control signal comprising sensing the feedback control signal using an implantable medical device.

27. The method of claim 22, wherein delivering the neurostimulation comprises delivering the neurostimulation through the at least one percutaneous stimulation electrode placed on an acupuncture point.

28. The method of claim 22, wherein delivering the neurostimulation comprises delivering the neurostimulation through the at least one percutaneous stimulation electrode lodged in or about a nerve of the autonomic nervous system.

29. The method of claim 28, wherein delivering the neurostimulation comprises delivering the neurostimulation through the at least one percutaneous stimulation electrode lodged in or about a vagus nerve.

30. The method of claim 22, wherein delivering the neurostimulation percutaneously comprises delivering the neurostimulation percutaneously to the stimulation target in the body through the at least one percutaneous stimulation electrode and a surface stimulation electrode configured to be placed on surface of the body.