Systems and methods for interacting with an implantable medical device

• US 20060212092A1
• Filed: 05/16/2006
• Published: 09/21/2006
• Est. Priority Date: 01/29/2002
• Status: Active Grant

• Current Assignee: Neuropace Inc.
• Original Assignee: Neuropace Inc.
• Inventors: Fischell, David R., Pless, Benjamin D., Gibb, Barbara, Upton, Adrian R.M., Guzzo, Lisa
• Granted Patent: US 8,140,160 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• 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. An interactive implantable medical device system for monitoring and treating a patient, comprising:

an external interactive computing device adapted for communication over a communications network; and

an implantable device having a communication subsystem adapted for bi-directional communication with the external device;

wherein the external interactive computing device is adapted to receive and store a data item from the patient;

wherein the external interactive computing device is further adapted to associate the data item with a storage record in the interactive computing device; and

wherein the external interactive computing device is further adapted to receive and store a data record from the implantable device.

2. The interactive implantable medical device system of claim 1, wherein the storage record comprises an EEG record received from the implantable device as a data record.

3. The interactive implantable medical device system of claim 1, wherein the storage record comprises a stored timestamp.

4. The interactive implantable medical device system of claim 1, wherein the external interactive computing device comprises a personal control unit.

5. The interactive implantable medical device system of claim 4, wherein the external interactive computing device comprises a portable computing device.

6. The interactive implantable medical device system of claim 5, wherein the portable computing device comprises a personal digital assistant.

7. The interactive implantable medical device system of claim 6, wherein the personal digital assistant comprises:

a wide area communications interface adapted for communications over the communications network; and

a local area communications network adapted for communication with the implantable device.

8. The interactive implantable medical device system of claim 7, wherein the personal digital assistant further comprises an expansion connector, and wherein the local area communications network comprises an expansion module attached to the expansion connector.

9. The interactive implantable medical device system of claim 1, wherein the data item comprises an entry in a seizure log.

10. The interactive implantable medical device system of claim 1, wherein the data item comprises a response to a query.

11. The interactive implantable medical device system of claim 10, wherein the query comprises a quality of life survey.

12. The interactive implantable medical device system of claim 10, wherein the query comprises a neuropsychiatric examination.

13. An interactive implantable medical device system for monitoring and treating a patient, comprising:

an external computing device adapted for communication over a data link; and

an implantable device having a communication subsystem adapted for bi-directional communication with the external computing device;

wherein the external computing device is adapted to receive and store a data item from the patient and to transmit the data item to a database.

14. An interactive implantable medical device system for monitoring and treating a patient, comprising:

an external interactive computing device adapted for communication over a communications network;

an implantable device having a communication subsystem adapted for bi-directional communication with the external device; and

a remote computing device adapted for communication over the communications network with the external interactive computing device;

wherein the remote computing device is adapted to receive a data item from the implantable device via the external interactive computing device, to process the data item, and to program the implantable device with a parameter derived at least in part from the data item.

15. The interactive implantable medical device system of claim 14, wherein the implantable device is adapted to apply a therapy in response to a detected event.

16. The interactive implantable medical device system of claim 15, wherein the therapy comprises electrical brain stimulation.

17. The interactive implantable medical device system of claim 15, wherein the detected event is identified by the implantable device based on the parameter.

18. A method for using an interactive implantable medical device system to monitor and treat a patient, the method comprising the steps of:

receiving a data item input from the patient with an external device;

storing the data item in the external device;

associating the data item with an existing storage record in the external device;

receiving a data record from an implantable device with the external device; and

storing the data record in the external device.

19. The method for using an interactive implantable medical device system of claim 18, wherein the existing storage record comprises an EEG record received from the implantable device.

20. The method for using an interactive implantable medical device system of claim 18, wherein the existing storage record comprises a stored timestamp.

21. The method for using an interactive implantable medical device system of claim 18, wherein the data item comprises an entry in a seizure log.

22. The method for using an interactive implantable medical device system of claim 18, wherein the data item comprises a response to a query.

23. The method for using an interactive implantable medical device system of claim 22, wherein the query comprises a quality of life survey.

24. The method for using an interactive implantable medical device system of claim 22, wherein the query comprises a neuropsychiatric examination.

25. A method for upgrading a software program in an interactive implantable medical device system, the method comprising the steps of:

transmitting a new software program from a repository to an intermediate device;

awaiting a connection between a target device and the intermediate device;

sending the new software program from the intermediate device to the target device;

verifying the correctness of the new software program; and

if the new software program is correct, replacing an old software program with the new software program in the target device.

26. The method for upgrading a software program in an interactive implantable medical device system of claim 25, wherein the intermediate device is a personal control unit

27. The method for upgrading a software program in an interactive implantable medical device system of claim 25, wherein the intermediate device is a programmer.

28. The method for upgrading a software program in an interactive implantable medical device system of claim 25, wherein the target device is an implantable neurostimulator.

29. A method for programming a target device in an interactive implantable medical device system, the method comprising the steps of:

awaiting a connection between the target device and a programming device;

sending a new parameter set from the programming device to the target device;

programming the new parameter set into the target device; and

updating a record in a database.

30. The method for upgrading a software program in an interactive implantable medical device system of claim 29, further comprising the steps of:

retrieving an old parameter set from the target device; and

modifying the old parameter set to obtain the new parameter set.

31. The method for upgrading a software program in an interactive implantable medical device system of claim 29, wherein the programming device is a personal control unit

32. The method for upgrading a software program in an interactive implantable medical device system of claim 29, wherein the programming device is a programmer.

33. The method for upgrading a software program in an interactive implantable medical device system of claim 29, wherein the programming device is the database.

34. The method for upgrading a software program in an interactive implantable medical device system of claim 29, wherein the target device is an implantable neurostimulator.

35. A method for avoiding overuse of interactive capabilities of an interactive implantable medical device system, the method comprising the steps of:

receiving a command input from a user;

verifying the identity of the user;

identifying the command input and associating the command input with a desired action;

accessing a history of command inputs from the user;

determining whether the action should be allowed based on the desired action, the history of command inputs, and a time of the command input; and

if the action should be allowed, performing the action.

36. The method for avoiding overuse of claim 35, wherein the step of determining whether the action should be allowed comprises querying a database.

37. A method for synchronizing an acting device in an interactive implantable medical device system with a database, the method comprising the steps of:

performing an action with the acting device;

storing a data representation of the action in the acting device

awaiting a connection between the acting device and the database; and

transmitting the data representation of the action to the database.

38. The method for synchronizing an acting device with a database of claim 37, wherein the acting device comprises an implantable neurostimulator.

39. The method for synchronizing an acting device with a database of claim 38, wherein the connection between the acting device and the database is an indirect link.

40. A method for using an interactive implantable medical device system in a deferred mode, the method comprising the steps of:

identifying a data item to transmit from a source device to a destination device;

awaiting a connection between the source device and the destination device;

if the connection is available, performing an action and transmitting the data item from the source device to the destination device; and

if the connection is not available, performing a conditional action and queueing the data item for later transmission.

41. The method for using an interactive implantable medical device system in a deferred mode of claim 40, wherein the source device comprises an implantable neurostimulator.

42. The method for using an interactive implantable medical device system in a deferred mode of claim 40, wherein the destination device comprises a database.

43. The method for using an interactive implantable medical device system in a deferred mode of claim 40, wherein the action comprises a commanded action desired by a user, and wherein the conditional action comprises at least a portion of the commanded action.

44. The method for using an interactive implantable medical device system in a deferred mode of claim 43, further comprising the step of receiving the data item from the user, wherein the data item comprises an authentication input from the user.

45. A method for using an interactive implantable medical device system to interrogate an implantable device and synchronize with a database, the method comprising the steps of:

awaiting a connection between the implantable device and an intermediate device;

transferring operation data between the implantable device and the intermediate device;

storing a data item in the intermediate device representative of the operation data;

awaiting a connection between the intermediate device and the database; and

transmitting the data item from the intermediate device to the database.

46. The method for using an interactive implantable medical device system of claim 45, wherein the implantable device comprises an implantable neurostimulator.

47. The method for using an interactive implantable medical device system of claim 46, wherein the operation data comprises a stored EEG record.

48. The method for using an interactive implantable medical device system of claim 46, wherein the operation data comprises a parameter set.

49. The method for using an interactive implantable medical device system of claim 46, wherein the operation data comprises diagnostic results.