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

• US 10,272,251 B2
• Filed: 06/28/2017
• Issued: 04/30/2019
• Est. Priority Date: 09/06/2013
• Status: Active Grant

• 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:
  US15/635,453
• Publication Number:
  US 20170296834A1
• Time in Patent Office: 671 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 plurality of electrodes selectable to provide stimulation to a patient'"'"'s tissue; and

control circuitry 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 control circuitry is configured to execute an algorithm to;

receive data from an external device;

identify an instruction in the received data;

determine whether the instruction complies with one or more of the instruction rules; and

execute the instruction to change the stimulation provided at the plurality of electrodes or to change an operational mode of the implantable medical device only if it is determined that the instruction is compliant with the one or more instruction rules.

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

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

4. The implantable medical device of claim 2, wherein the short-range communication 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 at least one of the instruction rules specifies a percentage change in stimulation amplitude that is not allowable.

7. The implantable medical device of claim 1, wherein at least one of the instruction rules specifies a percentage change in stimulation amplitude in a period of time that is not allowable.

8. The implantable medical device of claim 1, wherein at least one of the instruction rules specifies a percentage change in stimulation frequency that is not allowable.

9. The implantable medical device of claim 1, wherein execution of the algorithm further causes the control circuitry to retrieve the one or more instruction rules that are associated with the identified instruction.

10. The implantable medical device of claim 1, wherein the control circuitry is configured to store time-stamped current and historical settings of the implantable medical device.

11. The implantable medical device of claim 10, wherein executing the algorithm further causes the control circuitry to determine whether the instruction complies with at least one of the one or more instruction rules by evaluating the instruction and one or more of the time-stamped current or historical settings of the implantable medical device.

12. The implantable medical device of claim 1, wherein the control circuitry comprises a buffer that is configured to store the received data along with data previously received from the external device, data subsequently received from the external device, or both.

13. The implantable medical device of claim 12, wherein the control circuitry is configured to time stamp the data received from the external device.

14. The implantable medical device of claim 13, wherein executing the algorithm further causes the control circuitry to determine whether the instruction complies with at least one of the one or more instruction rules by evaluating the instruction and one or more instructions identified in data stored in the buffer.

15. A method implemented in an implantable medical device comprising a plurality of electrodes selectable to provide stimulation to a patient'"'"'s tissue, the method comprising:

executing an algorithm, using control circuitry in an implantable medical device 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, to;

receive data from an external device;

identify an instruction in the received data;

determine whether the instruction complies with one or more of the instruction rules; and

execute the instruction to change the stimulation provided at the plurality of electrodes or to change an operational mode of the implantable medical device only if it is determined that the instruction is compliant with the one or more instruction rules.

16. The method of claim 15, comprising:

receiving, at an antenna in the implantable medical device, the data from the external device;

demodulating the data in accordance with a short-range communication protocol; and

providing the data to the control circuitry.

17. The method of claim 15, wherein at least one of the instruction rules specifies a percentage change in a stimulation parameter that is not allowable.

18. The method of claim 15, wherein executing the algorithm further causes the control circuitry to retrieve the one or more instruction rules that are associated with the identified instruction.

19. The method of claim 15, wherein the control circuitry is configured to store time-stamped current and historical settings of the implantable medical device.

20. The method of claim 19, wherein executing the algorithm further causes the control circuitry to determine whether the instruction complies with at least one of the one or more instruction rules by evaluating the instruction and one or more of the time-stamped current or historical settings of the implantable medical device.