Method and apparatus for integrating implantable medical device data

• US 20080177346A1
• Filed: 01/22/2007
• Published: 07/24/2008
• Est. Priority Date: 01/22/2007
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Armstrong, Randolph K.
• Granted Patent: US 8,086,311 B2
• Time in Patent Office: Days
• US Class Current: 607/32
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Methods and systems for constructing a comprehensive history for an IMD are disclosed. The method includes interrogating an implantable medical device (IMD) with an interrogating external programmer device (EPD), and comparing a unique signature associated with the interrogating EPD to a stored signature, associated with a particular programmer device that most immediately previously programmed the IMD, in memory of the IMD. If the unique signature of the interrogating programmer device is not the same as the stored signature, the method includes recording the stored signature in the interrogating EPD. The method may optionally include replacing the stored signature in the IMD memory with the unique signature of the interrogating EPD if the interrogating EPD programs the IMD. A comprehensive history for the IMD may be constructed by tracing the values in the IMD and the programmer databases.

Claims

1. A method, comprising:

interrogating an implantable medical device (IMD) with an interrogating external programmer device (EPD);

comparing a unique signature associated with the interrogating EPD to a stored signature in memory of the IMD; and

retrieving the stored signature from the memory of the IMD;

wherein the retrieved signature is associated with a particular EPD that most immediately previously established communications with the IMD.

2. The method according to claim 1, wherein retrieval of the stored signature from the memory of the IMD is performed if the stored signature is not the same as the unique signature associated with the interrogating EPD.

3. The method according to claim 1, further comprising replacing the stored signature in the memory of the IMD with the unique signature of the current interrogating EPD.

4. The method according to claim 1, further comprising storing the retrieved signature in a memory of the interrogating EPD.

5. The method according to claim 1, wherein the stored signature is stored in a programmer history memory module of the IMD.

6. The method according to claim 1, wherein the unique signature comprises a serial number of the programmer device.

7. The method according to claim 4, wherein storing the retrieved signature in a memory of the EPD further comprises writing the retrieved signature to a local database of the interrogating EPD.

8. The method according to claim 1, further comprising reconstructing a comprehensive history for the IMD including the signature for each EPD that has programmed the IMD.

9. The method according to claim 8, further comprising constructing the comprehensive history for the IMD by:

retrieving the stored signature from the IMD to determine which EPD most immediately previously programmed the IMD;

retrieving a second signature stored in the local database of the EPD identified by the stored signature; and

storing the stored signature and the second signature to a comprehensive IMD history

10. The method according to claim 9, further comprising:

retrieving data associated with programming activity performed by at least one of the interrogating EPD and the EPD identified by the second signature; and

storing the retrieved data associated with programming activity in the comprehensive IMD history.

11. The method according to claim 9, further comprising:

if the comprehensive IMD history contains a signature for which data associated with programming activity has not yet been retrieved, retrieving the data associated with programming activity from the EPD programmer identified by that signature, and adding the retrieved data to the comprehensive IMD history.

12. The method according to claim 1, further comprising:

retrieving from the IMD a timestamp associated with a retrieved stored signature, said timestamp indicating when the EPD identified by the retrieved stored signature programmed said IMD.

13. The method according to claim 1, further comprising generating an indicator when the interrogating EPD detects previous programming by a programmer having a different signature.

14. A medical device, comprising:

an electrical signal generator comprising an instruction processor, the signal generator configured to deliver an electrical signal to a biological tissue;

a program memory for storing instructions that are directly executable by the instruction processor, and that control, at least in part, the operation of the medical device;

a data memory for storing operating parameters that are used by the instruction processor, and that control, at least in part, the operation of the medical device;

a programmer history memory that stores a unique first signature associated with a first external programming device (EPD) that most immediately previously programmed the medical device by communication with the instruction processor;

wherein the unique first signature stored in the programmer history memory is retrieved by a second EPD different from the first EPD for reconstructing a thread identifying each EPD that has programmed the medical device.

15. The device according to claim 14, wherein the instruction processor comprises a first control signal to alter at least a segment of the program memory or data memory on instruction from a second EPD, thereby modifying the operation of the medical device, and the instruction processor comprises a second control signal to write a unique second signature associated with the second EPD to replace the unique first signature in the programmer history memory, thereby updating the signature identifying the EPD that most immediately previously communicated with the medical device.

16. The device of claim 15, wherein the first and second signatures comprise a serial number for the respective EPD.

17. An external programmer device (EPD) operable to non-invasively monitor and program an implantable medical device (IMD), comprising:

an external device telemetry system operable for non-invasive wireless communication with the IMD;

a unique first signature identifying the EPD; and

a local database storing EPD activity data;

wherein upon interrogating the IMD, the EPD retrieves a stored signature from the IMD, to compares the retrieved signature to the unique first signature of the EPD and, stores the retrieved signature in the local database.

18. The EPD according to claim 17, wherein the EPD stores the retrieved signature in the local database after determining that the retrieved signature is not the same as the unique first signature of the EPD.

19. The EPD according to claim 17, further comprising:

a processor; and

a program memory storing software that, when executed, causes the processor to;

transmit a control signal to the IMD to alter operating parameters or programming stored in the IMD; and

transmit a control signal to the IMD to replace the stored signature in the IMD with the unique signature associated with the EPD.

20. The EPD according to claim 17, wherein the EPD activity data comprises, for each interaction with an IMD, at least one of:

a date of programming the IMD, a time of programming the IMD, an identifier for the IMD programmed, a change made to the programming of the IMD, and the stored signature stored in the IMD.

21. The EPD according to claim 17, wherein the unique signature comprises a serial number of the EPD.

22. The EPD according to claim 19, wherein the software, when executed, further causes the processor to construct a comprehensive history for the IMD by:

storing the retrieved signature identifying the second EPD to a memory;

retrieving from a database of the second EPD the programmer activity data associated with the second EPD and a second signature stored in the local database of the second EPD wherein said second signature identifies a third EPD that programmed the EPD prior to the second EPD; and

storing the programmer activity data associated with the second EPD and the second signature to a memory.

23. The EPD according to claim 22, wherein the software stored in the program memory, when executed, further causes the processor to construct the comprehensive history for the IMD by:

determining, by reviewing stored records associated with each signature identifying an EPD that has programmed the IMD, each EPD for which data associated with the programming activity of the EPD has not been retrieved;

retrieving data associated with the programming activity for each EPD identified in the previous step; and

storing the retrieved data associated with the programming history of each EPD.

24. A medical system, comprising:

an implantable medical device (IMD) configured to deliver an electrical signal to a biological tissue, the IMD comprising;

a programmer history memory that stores an EPD signature associated with a particular external programmer device (EPD) that most immediately previously programmed the IMD; and

a plurality of EPDs, each EPD comprising;

a local database storing data records of the activity of the particular EPD and a unique signature identifying the particular EPD from among said plurality of EPDs;

wherein upon interrogating the IMD via telemetric communication, an EPD of the plurality of EPDs retrieves the EPD signature from the programmer history memory to compare the retrieved EPD signature to the unique signature of the EPD that retrieved the signature and, if the retrieved EPD signature does not match the unique signature of the EPD that retrieved the signature, stores the retrieved signature in the local database.

25. The medical system according to claim 24, wherein the IMD further comprises:

an instruction processor; and

a program memory accessible by the instruction processor, the program memory comprising stored instructions that are directly executable from the program memory by the instruction processor and which control, at least in part, the operation of the IMD;

a data memory accessible by the instruction processor, the data memory comprising stored parameters that are directly accessible from the data memory by the instruction processor and which control, at least in part, the operation of the IMD;

wherein the instruction processor of the IMD comprises a first control signal to alter at least a segment of the program memory or data memory on instruction from an EPD, thereby modifying the operation of the device, and the instruction processor comprises a second control signal to write the unique signature associated with the EPD to replace the EPD signature in the programmer history memory;

thereby updating the signature identifying the EPD that most immediately previously altered the device.

26. The medical system according to claim 24, wherein the unique signature comprises a serial number of the EPD.

27. The medical system according to claim 24, wherein each EPD further comprises:

a processor; and

a program memory storing software that, when executed, causes the processor to;

transmit a control signal to the IMD to alter settings or programming; and

transmit a control signal to the IMD to replace the EPD signature in the IMD with the unique signature associated with the EPD programming the device.

28. The medical system according to claim 24, wherein the data records of the EPD activity comprise at least one of:

a date of programming the IMD, a time of programming the IMD, an identifier for the IMD programmed, a change made to the programming, and the EPD signature stored in the IMD.

29. The medical system according to claim 24, wherein the software stored in the program memory of the EPD, when executed, further causes the processor to constructing the comprehensive history for the IMD by:

retrieving the stored EPD signature from the IMD to determine which EPD most immediately previously programmed the IMD;

retrieving from the EPD identified by the retrieved EPD signature the programmer activity data associated with that EPD, as well as and a second signature stored in the local database thereof; and

adding the retrieved programmer activity data and the second signature to the comprehensive IMD history.

30. The medical system according to claim 24, wherein the software stored in the program memory of the EPD, when executed, further causes the processor to constructing the comprehensive history for the IMD by:

determining, by reviewing stored records associated with each signature identifying an EPD that has programmed the IMD, each EPD for which data associated with the programming activity of the EPD has not been retrieved;

retrieving data associated with the programming activity for each EPD identified in the previous step; and

storing the retrieved data associated with the programming history of each EPD.