Neurostimulator system, apparatus, and method

• US 10,286,213 B2
• Filed: 11/28/2016
• Issued: 05/14/2019
• Est. Priority Date: 01/15/2009
• Status: Active Grant

• Current Assignee: Realeve LLC
• Original Assignee: Autonomic Technologies, Inc. (Ford Motor Company)
• Inventors: Fletcher, Kellie, Hard, Patrick, Caparso, Anthony V., Tsuei, Karen
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US15/362,124
• Publication Number:
  US 20170072200A1
• Time in Patent Office: 897 Days
• Field of Search: 607 59, 607 60, 607 61
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36075 Headache or migraine
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• 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 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

An apparatus (10) for applying stimulation therapy to a patient includes an implantable medical device (20) and a remote controller (50) for inductively powering the medical device and communicating with the medical device. The remote controller (50) includes a feedback portion (220) for helping to establish a communication link between the remote controller and the implantable medical device (20).

Claims

1. An apparatus for applying neurostimulation therapy to a patient, the apparatus comprising:

an implantable neurostimulator; and

a remote controller for inductively powering the neurostimulator and communicating with the neurostimulator,

wherein the neurostimulator is configured to apply stimulation therapy to the patient according to stimulation parameters and therapy settings, all of which are stored in the implanted neurostimulator, wherein the neurostimulator is configured to store therapy gateway questions and answers inputted by the patient as a gateway to receiving stimulation therapy from the implanted neurostimulator.

2. The apparatus recited in claim 1, wherein the implanted neurostimulator is configured to apply the stimulation therapy to the patient according to the stimulation parameters and therapy settings stored on the implanted stimulator without receiving any patient specific or therapy specific data from the remote controller.

3. The apparatus recited in claim 1, wherein the implanted stimulator is configured to store all therapy session data regarding the stimulation therapy applied by the implanted neurostimulator.

4. The apparatus recited in claim 1, wherein the remote controller can be used to inductively power the implanted neurostimulator to apply the stimulation therapy to the patient according to the stimulation parameters and therapy settings stored on the implanted stimulator without any pre-programming or set up.

5. The apparatus recited in claim 1, wherein the remote controller is configured to set and adjust stimulation parameters and therapy settings stored on the implanted neurostimulator.

6. The apparatus recited in claim 1, wherein the implanted neurostimulator is configured to stimulate a peripheral, central, or autonomic neural structure.

7. The apparatus recited in claim 1, wherein the implanted neurostimulator is configured to stimulate a sphenopalatine (pterygopalatine) ganglion (SPG).

8. The apparatus recited in claim 1, wherein the implanted neurostimulator is configured to stimulate a neural structure in order to treat a primary headache.

9. The apparatus recited in claim 1, wherein the stimulation parameters and therapy settings programmed onto the neurostimulator comprise all of the patient and device specific information necessary to apply the stimulation therapy.

10. The apparatus recited in claim 1, wherein the remote controller is configured to control operation of the implanted neurostimulator without receiving or requiring any patient specific data or therapy specific data and is required only to inductively power the implanted neurostimulator.

11. An apparatus for applying neurostimulation therapy to a patient, the apparatus comprising:

an implantable neurostimulator; and

a remote controller for inductively powering the neurostimulator and communicating with the neurostimulator,

wherein the neurostimulator is configured to apply stimulation therapy to the patient according to stimulation parameters and therapy settings, all of which are stored in the implanted neurostimulator, wherein the remote controller is configured to query the patient to answer questions as a gateway to receiving stimulation therapy from implanted neurostimulator, and wherein the remote controller is configured to receive the gateway questions from the implanted neurostimulator and to transmit answers inputted by the patient to the implanted neurostimulator, where the answers are stored.

12. The apparatus recited in claim 11, wherein the remote controller is configured to query the patient to answer questions after receiving stimulation therapy from the implanted neurostimulator.

13. The apparatus recited in claim 12, wherein the remote controller is configured to receive the post-stimulation questions from the implanted neurostimulator and to transmit answers inputted by the patient to the implanted neurostimulator, where the answers are stored.

14. An apparatus for applying neurostimulation therapy to a patient, the apparatus comprising:

an implantable neurostimulator; and

a remote controller for inductively powering the neurostimulator and communicating with the neurostimulator,

wherein the neurostimulator is configured to apply stimulation therapy to the patient according to stimulation parameters and therapy settings, all of which are stored in the implanted neurostimulator, wherein the remote controller is programmed to query the patient to enter at least one of subjective and objective data regarding the patient'"'"'s condition as a gateway to receiving stimulation therapy from implanted neurostimulator, and wherein both the queries and the data elicited from the patient by the queries are stored on the implanted neurostimulator.

15. The apparatus recited in claim 14, wherein the subjective data comprises at least one of headache pain level data, sensitivity to light data, sensitivity to sound data, aura before headache onset data, nausea data, vomiting data, throbbing pain data, pulsating pain data, pain location data, activity/movement effect on pain data, stress level prior to onset data, tiredness data, and autonomic symptoms data comprising at least one of red eyes, tearing eyes, blocked nose, and eyelid swelling data.

16. The apparatus recited in claim 14, wherein the objective data comprises at least one of headache occurrence data, headache start/end time data, acute medication usage data, rescue medication usage data, medication start time data, food/beverage ingestion prior to headache onset data, sleep pattern data, physical location at headache onset data, and activity prior to headache onset data.

17. An apparatus for applying neurostimulation therapy to a patient, the apparatus comprising:

an implantable neurostimulator; and

a remote controller for inductively powering the neurostimulator and communicating with the neurostimulator,

wherein the neurostimulator is configured to apply stimulation therapy to the patient according to stimulation parameters and therapy settings, all of which are stored in the implanted neurostimulator, wherein the neurostimulator is the storage device for all patient specific stimulation parameters used to apply the stimulation therapy, all patient specific therapy settings that are used to apply the stimulation therapy, any gateway queries and data elicited from the gateway queries, and any post therapy queries and data elicited from the post therapy queries.