IP Library › Granted Patent US 12,444,497
Granted Patent B2
US 12,444,497 · App. 18/562,283 · Granted Oct 14, 2025

Neurostimulation parameter authentication and expiration system for neurostimulation

Inventors: Guillermo Alonso Calle (Moorpark, CA); Jacob Aaron Johnston (Moorpark, CA)
Assignee: SetPoint Medical Corporation
G16H40/40G16H20/30G16H40/67H04L9/3247H04L9/3268
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Quick Facts
Patent No.
US 12,444,497
App. No.
18/562,283
Granted
Oct 14, 2025
Kind
B2
Abstract

Methods and apparatuses (e.g., devices and systems) for securely accessing, activating and/or updating vagus nerve stimulators. In particular, described herein are methods and apparatuses for securing providing, verifying and/or executing digital prescriptions for implantable (including implanted) vagus nerve stimulation systems that may be used for treating inflammation. These methods and apparatuses (including software and/or firmware) may be adapted for used with low-energy requirements of the implanted components.

Claims (46)

1. A method of authorizing communication with an implanted therapy system, the method comprising:

receiving, in the implanted therapy system, a communication from a user with a digitally signed certificate and a date and/or time setting for the implanted therapy system with a second digitally signed certificate, wherein the digitally signed certificate was provided to the user by a remote server after verifying that the user is a clinician who has provided a recognized user name and password to the remote server;

verifying, by the implanted therapy system, that each of a digital signature on the digitally signed certificate and a digital signature on the second digitally signed certificate corresponds to an authorized user by either:

(1) using a unique, implant-specific key to confirm each of the digital signature on the digitally signed certificate and the digital signature on the second digitally signed certificate, wherein the implant-specific key is known only to the implanted therapy system and to the remote server, or

(2) using a public key maintained in the implanted therapy system to confirm that each of the digital signature on the digitally signed certificate and the digital signature on the second digitally signed certificate corresponds to a private key held by only the remote server;

modifying operation of the implanted therapy system based on the communication received from the authorized user, and

modifying the date and/or time setting of the implanted therapy system based on the received date and/or time setting once the digital signature on the second digitally signed certificate is verified.

2. The method of claim 1 , wherein modifying operation of the implanted therapy system comprises modifying a date and/or a time setting for the implantable therapy system.

3. The method of claim 1 , wherein modifying operation of the implanted therapy system comprises setting electrical stimulation parameters for the implantable therapy system.

4. The method of claim 3 , wherein the electrical stimulation parameters include an expiration date for the electrical stimulation parameters.

5. The method of claim 1 , further comprising transmitting, from the implanted therapy system to a user-accessible external processor, a notification that a predetermined number of stimulation treatments have been delivered or a predetermined date and/or time will be exceeded within a threshold number of stimulation treatments and/or a threshold period of time.

6. The method of claim 5 , further comprising displaying the notification in a user interface of the user-accessible external processor.

7. The method of claim 6 , further comprising facilitating the user requesting additional stimulation treatments on the user interface of the user-accessible external processor.

8. The method of claim 7 , further comprising denying the user additional stimulation treatments and prompting the user to visit a physician on the user interface of the user-accessible external processor.

9. The method of claim 4 , further comprising suspending electrical stimulation by the implanted therapy system after the expiration date or after a specified number of stimulation treatments have been delivered as counted in a nonvolatile memory of the implanted therapy system.

10. The method of claim 4 , further comprising suspending electrical stimulation by the implanted therapy system after the expiration date.

11. The method of claim 4 , further comprising suspending electrical stimulation by the implanted therapy system after the expiration date if the time/date of the implanted therapy system has been confirmed as correct.

12. The method of claim 4 , further comprising renewing the expiration date and/or time by receiving a second communication from the user that is verified by the implanted therapy system by verifying a digital signature on a second digitally signed certificate received with the second communication including the renewed expiration date and/or time.

13. The method of claim 3 , wherein the electrical stimulation parameters include a specified number of stimulation treatments.

14. The method of claim 13 , further comprising suspending electrical stimulation by the implanted therapy system after the specified number of stimulation treatments has been delivered as counted in a nonvolatile memory of the implanted therapy system.

15. The method of claim 1 , wherein the communication from the user with a digitally signed certificate is received by the implanted therapy system from the internet and/or a patient's smartphone.

16. The method of claim 1 , wherein modifying operation of the implanted therapy system comprises updating the software and/or firmware based on the communication.

17. An implantable therapy system for applying electrical stimulation to a nerve, the system comprising:

one or more electrodes; and

one or more processors in the implantable therapy system, the processor comprising a memory storing computer-program instructions, that, when executed by the one or more processors, perform a computer-implemented method comprising:

receiving, in the implanted therapy system, a communication from a user with a digitally signed certificate and a date and/or time setting for the implanted therapy system with a second digitally signed certificate, wherein the digitally signed certificate was provided to the user by a remote server after verifying that the user is a clinician who has provided a recognized user name and password to the remote server;

verifying, by the implanted therapy system, that each of a digital signature on the digitally signed certificate and a digital signature on the second digitally signed certificate corresponds to an authorized user by either:

(1) using a unique, implant-specific key to confirm each of the digital signature on the digitally signed certificate and the digital signature on the second digitally signed certificate, wherein the implant-specific key is known only to the implanted therapy system and to the remote server, or

(2) using a public key maintained in the implanted therapy system to confirm that each of the digital signature on the digitally signed certificate and the digital signature on the second digitally signed certificate corresponds to a private key held by only the remote server;

modifying operation of the implanted therapy system based on the communication received from the authorized user, and

modifying the date and/or time setting of the implanted therapy system based on the received date and/or time setting once the digital signature on the second digitally signed certificate is verified.

18. The system of claim 17 , wherein modifying operation of the implanted therapy system comprises modifying a date and/or a time setting for the implantable therapy system.

19. The system of claim 17 , wherein modifying operation of the implanted therapy system comprises setting electrical stimulation parameters for the implantable therapy system.

20. The system of claim 19 , wherein the electrical stimulation parameters include an expiration date for the electrical stimulation parameters.

21. The system of claim 17 , further comprising transmitting, from the implanted therapy system to a user-accessible external processor, a notification that a predetermined number of stimulation treatments have been delivered or a predetermined date and/or time will be exceeded within a threshold number of stimulation treatments and/or a threshold period of time.

22. The system of claim 21 , further comprising displaying the notification in a user interface of the user-accessible external processor.

23. The system of claim 22 , further comprising facilitating the user requesting additional stimulation treatments on the user interface of the user-accessible external processor.

24. The system of claim 23 , further comprising denying the user additional stimulation treatments and prompting the user to visit a physician on the user interface of the user-accessible external processor.

25. The system of claim 20 , further comprising suspending electrical stimulation by the implanted therapy system after the expiration date or after a specified number of stimulation treatments have been delivered as counted in a nonvolatile memory of the implanted therapy system.

26. The system of claim 20 , further comprising suspending electrical stimulation by the implanted therapy system after the expiration date.

27. The system of claim 20 , further comprising suspending electrical stimulation by the implanted therapy system after the expiration date if the time/date of the implanted therapy system has been confirmed as correct.

28. The system of claim 20 , further comprising renewing the expiration date and/or time by receiving a second communication from the user that is verified by the implanted therapy system by verifying a digital signature on a second digitally signed certificate received with the second communication including the renewed expiration date and/or time.

29. The system of claim 19 , wherein the electrical stimulation parameters include a specified number of stimulation treatments.

30. The system of claim 20 , further comprising suspending electrical stimulation by the implanted therapy system after the specified number of stimulation treatments has been delivered as counted in a nonvolatile memory of the implanted therapy system.

31. The system of claim 17 , wherein the communication from the user with a digitally signed certificate is received by the implanted therapy system from the internet and/or a patient's smartphone.

32. The system of claim 17 , wherein modifying operation of the implanted therapy system comprises updating the software and/or firmware based on the communication.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 30, 2024
From: CALLE, GUILLERMO ALONSO; JOHNSTON, JACOB AARON
To: SETPOINT MEDICAL CORPORATION
Reel/Frame 068129/0174 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 12, 2024
From: CALLE, GUILLERMO ALONSO; JOHNSTON, JACOB AARON
To: SETPOINT MEDICAL CORPORATION
Reel/Frame 068363/0878 →
Continuity (2)
Provisional Application 63189638 · May 17, 2021
Related Publication 20240242825A1 · Jul 18, 2024
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