Filtering algorithm for assessing communications wirelessly received by an implantable medical device

• US 9,717,919 B2
• Filed: 08/27/2014
• Issued: 08/01/2017
• Est. Priority Date: 09/06/2013
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Kothandaraman, Sridhar, Zottola, Dennis
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US14/470,756
• Publication Number:
  US 20150073500A1
• Time in Patent Office: 1,070 Days
• Field of Search: 607 59
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data

Abstract

A filtering algorithm implemented by a filtering module in an implantable medical device (IMD), or in an external device for communicating with an IMD, is disclosed which reviews blocks based on a number of rules. The filtering module preferably comprises both firewall and instruction analysis modules. The instruction analysis module analyzes the instructions and associated data (if present) in each block to determine whether such blocks would compromise operation of the IPG or injure a patient if executed. Instruction rules corresponding to an instruction identified in the block are retrieved by the instruction analysis module. The instruction analysis module reviews the block per the retrieved rules, and possibly also in light of current and historical IPG therapy setting or mode data, or other received but un-executed blocks. If a block is compliant, it is executed by the IMD or transmitted to the IMD.

Claims

1. An implantable medical device, comprising:

a microcontroller in the implantable medical device programmed with a filter module configured to implement a filtering algorithm, wherein the filter module is programmed with a plurality of instruction rules that each specify a type of therapy setting or operational mode setting that is not allowable, and wherein the filter module comprises;

an instruction analysis module configured to;

receive a data block;

determine an instruction in the data block, wherein the instruction comprises an instruction to set or adjust a therapy provided by the implantable medical device or an instruction to place the implantable medical device into one of a plurality of operational modes;

retrieve at least one instruction rule that corresponds the instruction, and

analyze the data block to determine if the data block is compliant with the retrieved at least one instruction rule;

wherein if the data block is compliant with the retrieved at least one instruction rule, the instruction analysis module allows the data block to pass, and

wherein if the data block is not compliant with the retrieved at least one instruction rule, the instruction analysis module rejects the data block.

2. The implantable medical device of claim 1, further comprising an antenna and demodulation circuitry configured to wirelessly receive the data block from an external device in accordance with a short-range communication protocol and to provide the data block to the microcontroller, wherein the antenna and demodulation circuitry are compliant with the short-range communication protocol.

3. The implantable medical device of claim 2, wherein the short-range protocol comprises a Near Field Communication (NFC) protocol.

4. The implantable medical device of claim 2, wherein the short-range protocol comprises a Frequency Shift Keying (FSK) protocol.

5. The implantable medical device of claim 2, wherein the short-range protocol comprises a Bluetooth, Bluetooth Low Energy (BLE), Zigbee, or WiFi protocol.

6. The implantable medical device of claim 1, wherein the instruction analysis module is configured to analyze the data block by assessing data associated with the instruction in the data block if such data is present.

7. The implantable medical device of claim 1, wherein the instruction analysis module is configured to analyze the data block for compliance with the retrieved at least one instruction rule by further analyzing current or historical implantable medical device data stored with the microcontroller.

8. The implantable medical device of claim 7, wherein the data block and historical implantable medical device data are time stamped, and wherein the instruction analysis module is configured to analyze the data block for compliance with the retrieved at least one instruction rule by further analyzing the time stamp of the data block and time stamps of the current or historical implantable medical device data.

9. The implantable medical device of claim 1, wherein the instruction analysis module further comprises a buffer for holding

at least one previously-received data block,

at least one subsequently-received data block, or

at least one previously-received data block and at least one subsequently-received data block,

and wherein the instruction analysis module is configured to analyze the data block for compliance with the retrieved at least one instruction rule by further analyzing an instruction in at least one of the previously-received or subsequently-received data blocks in the buffer.

10. The implantable medical device of claim 9, wherein the data blocks are time stamped, and wherein the instruction analysis module is configured to analyze the data block for compliance with the retrieved at least one instruction rule by further analyzing the time stamp of the data block and the time stamp of at least one of the previously-received or subsequently-received data blocks.

11. The implantable medical device of claim 1, wherein the filter module further comprises:

a firewall module configured to;

receive the data block;

provide one or more of packet, stateful, or application filtering of the data block in accordance with one or more of packet, stateful, or application filtering rules stored with the microcontroller,

wherein if the data block is compliant with the retrieved one or more of packet, stateful, or application filtering rules, the firewall module allows the data block to pass, and

wherein if the data block is not compliant with the retrieved one or more of packet, stateful, or application filtering rules, the firewall module rejects the data block.

12. The implantable medical device of claim 11, wherein operation of the firewall module precedes operation of the instruction analysis module such that the data block is first received at the firewall module of the filter module, and if the firewall module allows the data block to pass, the data block is received at the instruction analysis module.

13. The implantable medical device of claim 1, further comprising an instruction execution module, wherein if the data block is allowed to pass, it is executed by the instruction execution module to modify operation of the implantable medical device.

14. The implantable medical device of claim 1, further comprising a validity module for assessing one or both of an ID code or an error code in the data block, wherein the validity module is configured to do one or both of:

determine whether an ID code in the data block matches an ID code stored with the microcontroller;

determine whether an error code in the data block matches an error code calculated by the validity module,

wherein the validity module allows the data block to pass if compliant with either or both of the ID and error code determinations.

15. The implantable medical device of claim 14, wherein the validity module is programmed into the microcontroller.

16. The implantable medical device of claim 14, wherein operation of the validity module precedes operation of the filter module such that if the data block is allowed to pass the validity module, it is received at the filter module.

17. An implantable medical device, comprising:

a microcontroller in the implantable medical device programmed with an instruction analysis module that is programmed with a plurality of instruction rules that each specify a type of therapy setting or operational mode setting that is not allowable, wherein the instruction analysis module is configured to;

receive a data block, wherein the data block comprises an instruction and data associated with that instruction, wherein the instruction comprises an instruction to set or adjust a therapy provided by the implantable medical device or an instruction to place the implantable medical device into one of a plurality of operational modes; and

analyze the instruction and the data associated with the instruction to see if the data block is compliant with at least one instruction rule corresponding to the instruction;

wherein if the data block is compliant with the at least one instruction rule, the instruction analysis module allows the data block to pass, and

wherein if the data block is not compliant with the at least one instruction rule, the instruction analysis module rejects the data block.

18. The implantable medical device of claim 17, further comprising an antenna and demodulation circuitry configured to wirelessly receive the data block from an external device in accordance with a short-range communication protocol and to provide the data block to the microcontroller, wherein the antenna and demodulation circuitry are compliant with the short-range communication protocol.

19. The implantable medical device of claim 17, wherein the instruction comprises an instruction to set or adjust therapy provided by the implantable medical device, and wherein the data associated with the instruction comprises therapy settings or adjustments.

20. The implantable medical device of claim 17, wherein the instruction comprises an instruction for a particular therapy setting, and wherein the data associated with the instruction comprises the data for the particular therapy setting.

21. The implantable medical device of claim 17, wherein the instruction analysis module is configured to analyze the data block for compliance with the at least one instruction rule by further analyzing current or historical implantable medical device data stored with the microcontroller.

22. The implantable medical device of claim 21, wherein the data block and historical implantable medical device data are time stamped, and wherein the instruction analysis module is configured to analyze the data block for compliance with the at least one instruction rule by further analyzing the time stamp of the data block and time stamps of the current or historical implantable medical device data.

23. The implantable medical device of claim 17, wherein the instruction analysis module further comprises a buffer for holding

at least one previously-received data block,

at least one subsequently-received data block, or

at least one previously-received data block and at least one subsequently-received data block,

and wherein the instruction analysis module is configured to analyze the data block for compliance with the at least one instruction rule by further analyzing an instruction in at least one of the previously-received or subsequently-received data blocks in the buffer.

24. The implantable medical device of claim 23, wherein the blocks are time stamped, and wherein the instruction analysis module is configured to analyze the data block for compliance with the at least one instruction rule by further analyzing the time stamp of the data block and the time stamp of the at least one of the previously-received or subsequently-received data blocks.

25. The implantable medical device of claim 17, further comprising an instruction execution module, wherein if the data block is allowed to pass, it is executed by the instruction execution module to modify operation of the implantable medical device.

26. The implantable medical device of claim 17, wherein the at least one instruction rule is stored with the microcontroller.

27. The implantable medical device of claim 17, wherein at least one of the instruction rules specifies an increase in stimulation amplitude that is not allowable.