Systems and methods for interacting with an implantable medical device

• US 9,232,903 B2
• Filed: 07/07/2014
• Issued: 01/12/2016
• Est. Priority Date: 01/29/2002
• Status: Expired due to Term

• Current Assignee: Neuropace Inc.
• Original Assignee: Neuropace Inc.
• Inventors: Pless, Benjamin D, Gibb, Barbara, Guzzo, Lisa, Upton, Adrian R. M., Fischell, David R.
• Primary Examiner(s): GETZOW, SCOTT M
• Application Number:
  US14/324,486
• Publication Number:
  US 20140323902A1
• Time in Patent Office: 554 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/293 Invasive
• CPC Class Codes: A61B 5/375 using biofeedback
• CPC Class Codes: A61B 5/4094 Diagnosing or monitoring seizure diseases, e.g. epilepsy
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61N 1/36064 Epilepsy
• CPC Class Codes: A61N 1/36135 using physiological parameters
• 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 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

An interactive implantable medical device system includes an implantable medical device and a network-enabled external device capable of bi-directional communication and interaction with the implantable medical device. The external device is programmed to interact with other similarly-enabled devices. The system facilitates improved patient care by eliminating unnecessary geographic limitations on implantable medical device interrogation and programming, and by allowing patients, physicians, and other users to access medical records, history, and information and to receive status and care-related alerts and messages anywhere there is access to a communications network.

Claims

1. A medical system comprising:

a device adapted to be implanted in a human patient, and configured to;

sense signals from the patient, translate the sensed signals into data, store the data in a memory, and transmit the data over a wireless communication interface; and

an apparatus adapted to remain external of the patient, and configured to establish the wireless communication interface with the implanted device, receive a request from the implanted device to allow an action to occur, determine if the implanted device is already authenticated, allow the action when the implanted device is already authenticated and an elapsed time requirement is met, and deny the action until the implanted device becomes authenticated.

2. The system of claim 1, wherein the external apparatus is configured to allow one or more authentication retries when the implanted device is not already authenticated or the elapsed time requirement is not met.

3. The system of claim 1, wherein:

the implanted device is configured to generate an authentication code and transmit the code to the external apparatus; and

the external apparatus is configured to authenticate the source device based on the code.

4. The system of claim 1, wherein the external apparatus is configured to authenticate the source device based on biometric information of the patient.

5. The system of claim 1, wherein the action comprises uploading stored data from the implanted device to the external apparatus and the implanted device is configured to clear the data from the memory upon one of:

transmission of the data to the external apparatus, upon confirmation from the external apparatus that the data has been successfully received, or upon receipt of a clear command from the external apparatus.

6. The system of claim 1, wherein the implanted device is configured to store software code in the memory, the action comprises downloading new software code from the external apparatus to replace old software code in the implanted device, and the implanted device is configured to verify integrity of the downloaded new software code, maintain the old software code operative if the new software code is not verified, and replace the old software code with the new software code if the new software code is verified.

7. The system of claim 1, wherein the implanted device is configured to store a parameter set in the memory, and the action comprises downloading a new parameter set from the external apparatus to replace an old parameter set in the implanted device, and the implanted device is configured to verify successful download of the new parameter set, and notifying the external apparatus that a new parameter set is in place if the download is successful.

8. The system of claim 1, wherein the action comprises real-time monitoring of signals sensed by the implanted device, and the implanted device is configured to collect data corresponding to sensed signals, compress the data and transmit the compressed data to the external apparatus, and the external apparatus is configured to decompress the data, display it as a real-time data and store the data.

9. The system of claim 1, wherein the implanted device comprises a neurostimulator.

10. The system of claim 1, wherein the external apparatus comprises one of a database, a programmer, a base unit or a personal control unit.

11. A method for monitoring a condition of the patient with an implanted device and an external apparatus, said method comprising:

establishing a communications link between the implanted device and the external apparatus;

receiving, by the external apparatus, a request to allow an action to occur;

determining, by the external apparatus, if the implanted device is already authenticated;

allowing, by the external apparatus, the action when the implanted device is already authenticated and an elapsed time requirement is met; and

denying the action, by the external apparatus, until the implanted device becomes authenticated.

12. A medical system comprising:

a device adapted to be implanted in a human patient, and configured to communicate over a wireless communication interface; and

an apparatus adapted to remain external of the patient, and configured to establish the communication interface with the implanted device, receive a request from the implanted device to allow an action to occur, allow the action to occur when a time restriction related to a past request to perform the action is met, and deny the action when the time restriction related to a past request to perform the action is not met.

13. The system of claim 12, wherein the time restriction is based on a frequency of past requests to perform the action and the nature of the action.

14. The system of claim 12, wherein the time restriction comprises a restriction time period, and the external apparatus is configured to determine if the time restriction is met by being further configured to:

determine a difference between a current time corresponding to the time of the request to perform the action, and a past time corresponding to the time of the most recent past request to perform the action;

wherein the time restriction is determined to be met when the difference is at least equal to the restriction time period, and not to be met when the difference is less than the restriction time period.

15. A method for monitoring a condition of the patient with an implantable device and an external apparatus, comprising:

establishing a communications link between an implanted device and an external apparatus;

receiving, by the external apparatus, a request from the implanted device to allow an action to occur, the action having a time restriction related to a past request to perform the action;

allowing the action to occur, by the external apparatus, when the time restriction related to a past request to perform the action is met; and

denying the action, by the external apparatus, when the time restriction related to a past request to perform the action is not met.

16. The method of claim 15, wherein the time restriction is based on a frequency of past requests to perform the action and the nature of the action.

17. The method of claim 15, wherein the time restriction comprises a restriction time period, and further comprising

determining, by the external apparatus, a difference between a current time corresponding to the time of the request to perform the action, and a past time corresponding to the time of the most recent past request to perform the action;

wherein the time restriction is determined to be met when the difference is at least equal to the restriction time period, and not to be met when the difference is less than the restriction time period.