APPARATUS AND METHOD FOR REMINDING, PROMPTING, OR ALERTING A PATIENT WITH AN IMPLANTED STIMULATOR

• US 20180001096A1
• Filed: 02/03/2016
• Published: 01/04/2018
• Est. Priority Date: 02/03/2015
• Status: Active Grant

• Current Assignee: Setpoint Medical Corporation
• Original Assignee: Setpoint Medical Corporation
• Inventors: FALTYS, Michael A., LEVINE, Jacob A., BLOCK, Richard A.
• Granted Patent: US 11,406,833 B2
• Time in Patent Office: Days
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 40/63 for local operation

Abstract

An implanted stimulator can deliver a patient-detectable electrical stimulation to remind or prompt a patient to interact with an implanted therapeutic device (e.g., neurostimulator) when a prompting event occurs. For example, the apparatuses and methods described herein may be configured to apply a prompting patient-detectable electrical vagus nerve stimulation to remind a patient that it is time to administer a therapeutic dose. When the therapeutic device is operated in an automatic fashion, the apparatus can also deliver a patient-detectable warning stimulation prior to the therapeutic stimulation to let the patient know that a therapeutic stimulation will be delivered soon thereafter.

Claims

1. A method for prompting a patient to interact with a therapy device implanted in the patient, the method comprising:

determining, in a processor, if the patient should interact with the therapy device; and

delivering a patient-detectable stimulation from the implanted therapy device when the processor determines that the patient should interact with the therapy device, wherein the patient-detectable prompting stimulation is different from a therapeutic dose for the implanted therapy device.

5. The method of claim 1, wherein delivering the patient-detectable prompting stimulation comprises delivering electrical stimulation to the subject'"'"'s vagus nerve from the implanted therapy device.

6. The method of claim 1, wherein determining if the patient should interact with the therapy device comprises determining if a prompting event has occurred, wherein the prompting event is selected from the group comprising:

the implant requires charging, the implant requires maintenance, or it is time to prompt the patient to manually activate the implanted therapy device to deliver a therapeutic dose.

8. The method of claim 1, wherein delivering the patient-detectable prompting stimulation comprises delivering a stimulation that has a lower amplitude and duration than the therapeutic dose from the implanted therapy device.

9. The method of claim 1, wherein delivering the patient-detectable prompting stimulation comprises delivering electrical stimulation to the patient'"'"'s vagus nerve from the implanted therapy device at a lower amplitude than the therapeutic dose applied to the patient'"'"'s vagus nerve from the implanted therapy device.

10. The method of claim 1, wherein determining comprises determining in a processor in the implant.

11. The method of claim 1, further comprising determining that the patient has failed to interact with the therapy device following delivery of the patient-detectable prompting stimulation and delivering a second patient-detectable prompting stimulation.

14. The method of claim 1, wherein the therapeutic stimulation comprises electrical stimulation to the vagus nerve.

18. The system of claim 14 where in the processor is programmed to determining if the prompting event has occurred wherein the prompting event is selected from the group comprising:

the implant requires charging, the implant requires maintenance, or it is time to prompt the patient to manually activate the implanted therapy device to deliver the therapeutic dose.

19. The system of claim 14 wherein the processor is programmed to determine whether the patient has interacted with the system by a predetermined time after triggering delivery and to trigger a second patient-detectable prompting stimulation from the neurostimulator if the patient has not.

20. The system of claim 14, wherein the neurostimulator is configured to be triggered by the processor to deliver the patient-detectable stimulation.

21. The system of claim 14, wherein the neurostimulator is configured to be triggered by the processor to deliver the patient-detectable stimulation, wherein the patient-detectable stimulation has a lower amplitude and duration than the therapeutic dose from the neurostimulator.

22. The system of claim 14, wherein the neurostimulator is configured to be triggered by the processor to deliver the patient-detectable stimulation, wherein the patient-detectable stimulation has a lower amplitude than the therapeutic dose.

23. The system of claim 14, wherein the processor is housed within the implantable neurostimulator.

2. A method for prompting a patient to interact with a therapy device implanted in the patient, the method comprising:

determining, in a processor, if the patient should interact with the therapy device based on a prompting event selected from the group comprising;

the implant requires charging, the implant requires maintenance, or it is time to prompt the patient to manually activate the implanted therapy device to deliver a therapeutic dose; and

delivering a patient-detectable prompting stimulation from the implanted therapy device when the processor determines that the patient should interact with the therapy device, wherein the patient-detectable stimulation is different from a therapeutic dose for the implanted therapy device.

12. The method of claim 2 wherein delivering the patient-detectable prompting stimulation comprises delivering a patient-detectable prompting stimulation that is characteristic of the prompting event.

3. A method for prompting a patient to interact with a therapy device implanted in the patient, the method comprising:

determining that the patient should interact with the therapy device to manually activate the implanted therapy device to deliver a therapeutic stimulation, wherein determining comprises comparing a current time with a scheduled stimulation time; and

delivering a patient-detectable prompting stimulation from the implanted therapy device to remind the patient to manually activate the implanted therapy device to apply therapeutic stimulation from the implanted therapy device when the current time falls within a reminder time period prior to the scheduled stimulation time.

7. The method of claim 3, further comprising determining whether the patient has delivered the therapeutic stimulation by the scheduled stimulation time.

13. The method of claim 3, wherein the reminder period is about 15 minutes or less.

4. A method for alerting a patient that an implanted therapy device will be delivering a therapeutic dose prior to delivery of the dose, the method comprising:

determining, in a processor, that the therapeutic device is scheduled to deliver a therapeutic dose within a predetermined reminder time period from a current time; and

delivering a patient-detectable stimulation from the implanted therapy device prior to delivery of the therapeutic dose when the processor determines that the therapeutic dose will be delivered within the predetermine reminder time period, wherein the patient-detectable prompting stimulation is different from a therapeutic dose for the implanted therapy device.

15. A vagus nerve stimulation system that prompts a patient to interact with the system, the system comprising:

an implantable neurostimulator configured to electrically stimulate a vagus nerve of the patient to deliver a therapeutic dose; and

a processor, wherein the processor is programmed to;

determine if a prompting event has occurred, and

trigger delivery of a patient-detectable prompting stimulation from the neurostimulator when the processor determines that the patient should interact with the neurostimulator, wherein the patient-detectable stimulation is different from the therapeutic dose.

16. A vagus nerve stimulation system that prompts a patient to interact with the system, the system comprising:

an implantable neurostimulator configured to electrically stimulate a vagus nerve of the patient to deliver a therapeutic dose; and

a processor in communication with the neurostimulator, wherein the processor is programmed to;

determine if the patient should interact with the neurostimulator based on a prompting event selected from the group comprising;

the implant requires charging, the implant requires maintenance, or it is time to prompt the patient to manually activate the implanted neurostimulator to deliver the therapeutic dose, and

trigger delivery of a patient-detectable prompting stimulation from the neurostimulator when the processor determines that the patient should interact with the neurostimulator, wherein the patient-detectable stimulation is different from the therapeutic dose.

17. A vagus nerve stimulation system that prompts a patient prior to providing a scheduled therapeutic dose, the system comprising:

an implantable neurostimulator configured to electrically stimulate a vagus nerve of the patient to deliver a therapeutic dose at a dosing schedule; and

a processor, wherein the processor is programmed to;

determine if the neurostimulator is scheduled to deliver the therapeutic dose within a predetermined reminder time period from a current time, and

trigger delivery of a patient-detectable prompting stimulation from the neurostimulator when the processor determines that the therapeutic dose will be delivered within the predetermine reminder time period, wherein the patient-detectable stimulation is different from the therapeutic dose.