Implantable medical device with reconfigurable non-volatile program

• US 7,489,561 B2
• Filed: 10/24/2005
• Issued: 02/10/2009
• Est. Priority Date: 10/24/2005
• Status: Active Grant

• Current Assignee: LivaNova USA, Inc. (LivaNova Plc)
• Original Assignee: Cyberonics, Inc
• Inventors: Armstrong, Randolph K., Armstrong, Scott A.
• Primary Examiner(s): DINH, SON T
• Application Number:
  US11/257,267
• Publication Number:
  US 20070091687A1
• Time in Patent Office: 1,205 Days
• Field of Search: 365/185.29, 365/185.11, 607/2
• US Class Current: 365/185.29
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware

Abstract

A device comprises a stimulus generator comprising an instruction processor. The stimulus generator is configured to deliver stimuli to a biological tissue. The device also comprises a non-volatile memory for storing instructions directly executable by the instruction processor, the instructions controlling, at least in part, the operation of the device. The instruction processor generates an erase control signal to erase at least a segment of the non-volatile memory and a write control signal to write one or more new instructions to at least a segment of the non-volatile memory, thereby modifying the operation of the device.

Claims

1. A device, comprising:

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

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

wherein the instruction processor comprises an instruction erase control signal to erase at least a segment of the non-volatile memory and an instruction write control signal to write one or more new instructions to the erased segment of the non-volatile memory, thereby modifying the operation of the device.

2. The device of claim 1 wherein the non-volatile memory comprises Flash memory.

3. The device of claim 1 wherein the non-volatile memory comprises EEPROM.

4. The device of claim 1 wherein the non-volatile memory is integrated with the instruction processor.

5. The device of claim 1 further comprising error checking logic configured to securely authenticate the one or more new instructions before generation of the erase control signal or the write control signal.

6. The device of claim 1, wherein the non-volatile memory is further operable for storing one or more therapy parameters, and wherein the instruction processor further comprises a data erase control signal to erase at least a segment of the non-volatile memory and a data write control signal to write one or more new therapy parameters to the erased segment of non-volatile memory, thereby modifying the therapy delivered by the device.

7. A medical system, comprising:

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

an instruction processor;

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

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

wherein the instruction processor, upon a command to update, generates an erase control signal to erase at least a segment of the non-volatile memory and a write control signal to write one or more new instructions to the erased segment of the non-volatile memory, thereby modifying the operation of the IMD; and

the system also comprising;

an external device comprising an external device telemetry system operable for non-invasive wireless communication of one or more new instructions to the IMD telemetry system.

8. The system of claim 7 wherein the non-volatile memory comprises Flash memory.

9. The system of claim 7 wherein the non-volatile memory comprises EEPROM.

10. The system of claim 7 wherein the non-volatile memory is integrated with the instruction processor.

11. The system of claim 7 further comprising error correction logic configured to securely authenticate the one or more new instructions sent by the external device before generation of the erase control signal or the write control signal.

12. A method of updating an implantable medical device (IMD) having a non-volatile memory, comprising:

writing a first program executable by an instruction processor and configured to operate the IMD in a non-volatile memory;

executing the first program directly from the non-volatile memory;

erasing at least a segment of the non-volatile memory;

writing a second program executable by the instruction processor and configured to operate the IMD to the erased segment of the non-volatile memory; and

executing the second program directly from the non-volatile memory.

13. The method of claim 12 further comprising resetting the IMD to trigger said erasing and writing.

14. The method of claim 12 wherein erasing the segment of the non-volatile memory comprises generating an erase control signal by the instruction processor.

15. The method of claim 14 wherein erasing the segment of the non-volatile memory comprises receiving a command from a programmer to generate the erase control signal by the instruction processor.

16. The method of claim 12 wherein writing the second program to the erased segment of the non-volatile memory comprises generating a write control signal by the instruction processor.

17. The method of claim 16 wherein writing the second program to the erased segment of the non-volatile memory comprises receiving a command from a programmer to generate the write control signal by the instruction processor.

18. The method of claim 12 further comprising error checking the second program.

19. The method of claim 18, wherein error checking comprises running a CRC algorithm.

20. The method of claim 12 wherein writing the first program in the non-volatile memory comprises writing the first program in Flash memory.

21. The method of claim 12 wherein writing the first program in the non-volatile memory comprises storing the first program in EEPROM.

22. The method of claim 12 wherein writing the second program to the erased segment of the non-volatile memory further comprises writing the second program in Flash memory.

23. The method of claim 12 wherein writing a second program to the erased segment of the non-volatile memory further comprises writing the second program in EEPROM.

24. The method of claim 12 further comprising:

writing one or more therapy parameters, used by a program configured to operate the IMD and executable by the instruction processor, in a non-volatile memory;

erasing a segment of the non-volatile memory; and

writing at least one new therapy parameter to the erased segment of the non-volatile memory, the new therapy parameters being used by the program executable by the instruction processor, thereby altering the therapy delivered.