Approval per use implanted neurostimulator

• US 9,320,908 B2
• Filed: 01/15/2010
• Issued: 04/26/2016
• Est. Priority Date: 01/15/2009
• Status: Active Grant

• Current Assignee: Realeve LLC
• Original Assignee: Autonomic Technologies, Inc. (Ford Motor Company)
• Inventors: Fletcher, Kellie S., Pless, Benjamin David, Caparso, Anthony, Horne, Kenneth N.
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US12/688,524
• Publication Number:
  US 20100179617A1
• Time in Patent Office: 2,293 Days
• Field of Search: 607/59, 607/60
• US Class Current: 1/1
• CPC Class Codes: A61N 1/36075 Headache or migraine
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/36142 for improving safety
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Methods and apparatus for delivering therapy from an implanted neurostimulator to a patient are provided. One feature is an external controller that acts as a gateway for therapy. The external controller can be a handheld controller that communicates wirelessly with the implanted neurostimulator. In some embodiments, the controller communicates with a database to determine a therapy approval status of the neurostimulator. Therapy can be approved by a physician prescription, or by prepayment, for example. In some embodiments, the neurostimulator is deactivated when no approved therapies remain.

Claims

1. A method of approving therapy in a patient, comprising:

implanting a medical device in the patient;

approving a set number of approved therapies to be delivered from the medical device to the patient; and

deactivating the medical device when no approved therapies remain.

2. The method of claim 1 wherein the approving step further comprises approving a set number of therapies to be delivered from the medical device to the patient with a physician prescription.

3. The method of claim 1 wherein the approving step further comprises approving a set number of therapies to be delivered from the medical device to the patient with payment by the patient.

4. The method of claim 1 further comprising checking a therapy approval status of the medical device with a handheld controller.

5. The method of claim 4 further comprising directing the medical device to deliver therapy to the patient with the handheld controller.

6. The method of claim 1 further comprising re-activating the medical device by approving an additional number of therapies to be delivered from the medical device to the patient.

7. The method of claim 1 further comprising storing a therapy approval status of the medical device on a database.

8. The method of claim 7 further comprising accessing the database with a handheld controller to determine the therapy approval status of the medical device.

9. The method of claim 1 wherein the medical device is a neurostimulator.

10. The system of claim 1 wherein the set number of approved therapies comprises a pre-determined number of approved therapies.

11. A system for delivering therapy to a patient, comprising:

an implantable neurostimulator configured to deliver therapy to the patient;

a database containing a count of approved therapies of the implantable neurostimulator; and

an external controller in communication with the database and the implantable neurostimulator, the external controller configured to direct the implantable neurostimulator to deliver therapy to the patient if approved therapies remain.

12. The system of claim 11 wherein the implantable neurostimulator is sized and configured to be implanted on or near a sphenopalatine ganglion.

13. The system of claim 11 wherein the external controller is a handheld controller.

14. The system of claim 11 wherein the external controller is configured to update and store a list of the count of remaining approved therapies of the implantable neurostimulator.

15. The system of claim 11 wherein the external controller is in wireless communication with the implantable neurostimulator and the database.

16. The system of claim 11 wherein the therapy is electrical stimulation.

17. The system of claim 11 wherein the external controller is configured to deactivate the implantable stimulator if no approved therapies remain.

18. The system of claim 11 wherein the database is stored remotely from the implantable neurostimulator and the external controller.

19. The system of claim 11 wherein the controller is configured to direct the database to deduct an approved therapy from the count of approved therapies when therapy is delivered to the patient.

20. A method of delivering therapy to a patient, comprising:

implanting a neurostimulator in the patient;

checking on a database a count of approved therapies of the neurostimulator;

if the count of approved therapies is greater than zero, delivering therapy from the implanted neurostimulator to the patient; and

deducting an approved therapy from the count of approved therapies on the database.