Percutaneous neurostimulator for modulating cardiovascular function

• US 8,688,211 B2
• Filed: 08/26/2010
• Issued: 04/01/2014
• 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: Libbus, Imad, Caparso, Anthony V., Kramer, Andrew P.
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US12/869,579
• Publication Number:
  US 20100324620A1
• Time in Patent Office: 1,314 Days
• Field of Search: 607/2, 607/12, 607/17, 607/30, 607/59, 607/142, 607/149, 607/32, 600/523, 128/907
• US Class Current: 607/17
• 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 modulating a cardiovascular function in a body by stimulating a target nerve at a stimulation site in the body, the system comprising:

a percutaneous neurostimulation device including;

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

an external neurostimulator configured to be electrically wired to the at least one percutaneous stimulation electrode to allow for delivery of electrical neurostimulation pulses percutaneously from the external stimulator to the stimulation site through the at least one percutaneous stimulation electrode, the electrical neurostimulation pulses capable of directly eliciting action potentials in the target nerve, the external neurostimulator including;

a stimulation output circuit configured to deliver the electrical neurostimulation pulses;

a memory circuit storing a stimulation algorithm including parameters selected to modulate the cardiovascular function; and

a stimulation controller coupled to the stimulation output circuit and the memory circuit, the stimulation controller configured to control the delivery of the electrical neurostimulation pulses by executing the stimulation algorithm; 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.

2. The system of claim 1, wherein the stimulation controller comprises a feedback controller configured to control the delivery of electrical neurostimulation pulses using a feedback control signal indicative of a cardiac function, and the external neurostimulator comprises an external sensor coupled to the feedback controller and configured to sense the feedback control signal.

3. The system of claim 1, wherein the memory circuit is configured to store a history of the delivery of electrical neurostimulation pulses by the external neurostimulator.

4. The system of claim 1, wherein the bracing element is configured for holding the external neurostimulator on a knee or neck of the body.

5. The system of claim 4, wherein the user interface comprises a user input device and a presentation device.

6. The system of claim 5, wherein the portable user communication device comprises a further bracing element coupled to the communicator and configured to hold the communicator on the body by bracing a lower arm or wrist of the body.

7. The system of claim 5, wherein the user input device comprises a power switch to turn the external neurostimulator on/off.

8. The system of claim 7, 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.

9. The system of claim 8, 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.

10. 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.

11. The system of claim 10, wherein the wire electrode comprises a needle electrode, and the wire is substantially rigid.

12. The system of claim 10, wherein the wire electrode comprises a flexible electrode, and the wire is substantially flexible.

13. The system of claim 10, wherein the distal end of the wire comprises a hook or barbs.

14. 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.

15. The system of claim 14, wherein the implantable capsule is configured to be implanted into the body by injection using a hollow needle or catheter.

16. The system of claim 14, 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.

17. 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 configured to deliver neurostimulation percutaneously to the stimulation target in the body through the at least one percutaneous stimulation electrode and the surface stimulation electrode.

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

a percutaneous neurostimulation device including;

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

an external neurostimulator configured to be electrically wired to the at least one percutaneous stimulation electrode to allow for delivery of electrical neurostimulation pulses percutaneously from the external stimulator to the stimulation site through the at least one percutaneous stimulation electrode, the external neurostimulator including;

a stimulation output circuit configured to deliver the electrical neurostimulation pulses;

a memory circuit storing a stimulation algorithm including parameters selected to modulate the cardiovascular function; and

a stimulation controller coupled to the stimulation output circuit and the memory circuit, the stimulation controller configured to control the delivery of the electrical neurostimulation pulses by executing the stimulation algorithm; 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,

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.

19. A system for modulating a cardiovascular function in a body by stimulating and a target nerve at a stimulation site in the body and a heart in the body, the system comprising:

a percutaneous neurostimulation device including;

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

an external neurostimulator configured to be electrically wired to the at least one percutaneous stimulation electrode to allow for delivery of electrical neurostimulation pulses percutaneously from the external stimulator to the stimulation site through the at least one percutaneous stimulation electrode, the electrical neurostimulation pulses capable of directly eliciting action potentials in the target nerve, the external neurostimulator including;

a stimulation output circuit configured to deliver the electrical neurostimulation pulses;

a memory circuit storing a stimulation algorithm including parameters selected to modulate the cardiovascular function; and

a stimulation controller coupled to the stimulation output circuit, the stimulation controller configured to control the delivery of electrical neurostimulation pulses by executing the stimulation algorithm, the stimulation controller including a feedback controller configured to control the delivery of electrical neurostimulation pulses using a feedback control signal; and

a stimulator telemetry circuit configured to receive the feedback control signal via telemetry; 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

an implantable medical device configured to be communicatively coupled to the external neurostimulator and including;

a cardiac rhythm management circuit configured to deliver cardiac electrical stimulation to the heart, the cardiac rhythm management circuit including at least a pacemaker;

a sensor configured to sense a physiologic signal;

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

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

20. The system of claim 19, wherein the memory circuit is configured to store a history of the delivery of electrical neurostimulation pulses by the external neurostimulator.

21. The system of claim 19, wherein the bracing element comprises one or more of a belt having an adjustable length and a sleeve having an adjustable length.

22. The system of claim 21, wherein the external neurostimulator comprises a user interface coupled to the stimulation controller, the user interface including a user input device and a presentation device.