Medical device programming safety

• US 7,848,819 B2
• Filed: 11/15/2007
• Issued: 12/07/2010
• Est. Priority Date: 12/06/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Goetz, Steven M., Drew, Touby A., Keacher, Jeffrey T., Roberts, Earle T., Houchins, Andrew H., Stone, Theodore J., Johnson, Donald R.
• Primary Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US11/940,573
• Publication Number:
  US 20080140161A1
• Time in Patent Office: 1,118 Days
• Field of Search: None
• US Class Current: 607/59
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals
• CPC Class Codes: A61N 1/3727 characterised by the modulation technique
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Techniques for increasing the safety of medical device programming using general purpose hardware, such as a general purpose personal computer, are described. Some embodiments include a watchdog module that is serviced by the general purpose hardware, a mediator module that monitors programming instructions from the general purpose hardware, and/or a safe mode input that may be activated by a user. In some embodiments, a system comprises an implantable medical device, an intermediate device, a computing device that communicates with the implantable medical device via the intermediate device. The intermediate device may provide any one or more of the safety measures described above. In some embodiments, the intermediate device is dedicated hardware, and critical programming functions are provided by the intermediate device, rather than the general purpose hardware. In some embodiments, an implantable medical device provides one or more of the above-discussed safety features, rather than a separate intermediate device.

Claims

1. A method comprising:

receiving programming instructions for a medical device from a computing device, wherein the programming instructions comprise a first set of programming instructions and a second set of programming instructions;

analyzing a content of the first set of programming instructions;

determining whether the content of the first set of programming instructions is logically valid;

if the content of the first set of programming instructions is not logically valid, refusing further receipt of the second set of programming instructions from the computing device until an indication that the computing device has been reset is received; and

transmitting the first set of programming instructions to the medical device if the content of the first set of programming instructions is logically valid.

2. The method of claim 1, wherein receiving programming instructions from the computing device comprises receiving programming instructions at an intermediate computing device, and wherein analyzing the content of the first set of programming instructions comprises analyzing the content of the first set of programming instructions at the intermediate computing device.

3. The method of claim 2, wherein transmitting the first set of programming instructions to the medical device if the content of the first set of programming instructions is logically valid comprises transmitting the first set of programming instructions from the intermediate computing device to the medical device if the content of the first set of programming instructions is logically valid.

4. The method of claim 1, wherein analyzing the content of the first set of programming instructions comprises analyzing the content of the first set of programming instructions at the medical device.

5. The method of claim 1, wherein the computing device comprises at least one of an intermediate computing device, a patient programming device, or a clinician programmer.

6. The method of claim 1, further comprising placing the medical device in a known safe mode if the content of the first set of programming instructions is not logically valid.

7. The method of claim 1, wherein analyzing the content of the first set of programming instructions comprises comparing a therapy parameter value of the first set of programming instructions to at least one of a device-specific range of acceptable therapy parameter values, a patient-specific range of acceptable therapy parameter values, or medication dosage instructions.

8. The method of claim 7, wherein at least one of the device-specific range, the patient-specific range or the medication dosage instructions is stored within at least one of the medical device or an intermediate computing device.

9. The method of claim 1, wherein receiving programming instructions from the computing device comprises receiving the programming instructions during the course of a programming session between the computing device and the medical device, the method further comprising:

periodically receiving a defined signal from the computing device during the course of the programming session;

transmitting the first set of programming instructions to the medical device if the content of the programming instructions is logically valid; and

transmitting alternative instructions to the medical device instead of the first set of programming instructions in response to an interruption in transmission of the defined signal.

10. The method of claim 1, further comprising prompting a user to validate the content of the first set of programming instructions if the content of the first set of programming instructions is not logically valid.

11. A system comprising:

a computing device; and

a mediator module that is configured to;

receive programming instructions for a medical device from the computing device, wherein the programming instructions comprise a first set of programming instructions and a second set of programming instructions,

analyze a content of the first set of programming instructions,

determine whether the content of the first set of programming instructions is logically valid based on the analysis, wherein if the content of the first set of programming instructions is not logically valid, refusing further receipt of the second set of programming instructions from the computing device until an indication that the computing device has been reset is received, and

transmit the first set of programming instructions to the medical device if the content of the first set of programming instructions is logically valid.

12. The system of claim 11, further comprising the medical device, wherein the medical device comprises the mediator module.

13. The system of claim 11, further comprising an intermediate computing device configured to communicate with the computing device and the medical device, wherein the intermediate device comprises the mediator module.

14. The system of claim 13, wherein the intermediate computing device comprises a safe mode interface, wherein the intermediate computing device is configured to transmit alternative instructions to the medical device instead of the first set of programming instructions in response to receiving an input from a user via the safe mode interface.

15. The system of claim 11, wherein the computing device comprises at least one of a patient programming device, a clinician programmer or a personal computer.

16. The system of claim 11, further comprising a watch dog module, wherein the computing device periodically transmits a defined signal to the watch dog module, and wherein the mediator module transmits the first set of programming instructions to the medical device if the defined signal is uninterrupted and transmits alternative instructions to the medical device instead of the first set of programming instructions in response to an interruption in transmission of the defined signal.

17. The system of claim 11, wherein the mediator module is configured to analyze the content of the first set of programming instructions by at least comparing a therapy parameter value set forth by the programming instructions to at least one of a device-specific range of acceptable therapy parameter values, a patient-specific range of acceptable therapy parameter values, or medication dosage instructions.

18. The system of claim 11, further comprising a user interface to interact with the mediator module, wherein the mediator module is configured to prompt a user via the user interface to validate the content of the first set of programming instructions if the content of the first set of programming instructions is not logically valid.

19. A computer-readable medium comprising instructions that cause a processor to:

receive programming instructions for a medical device from a computing device, wherein the programming instructions comprise a first set of programming instructions and a second set of programming instructions;

analyze a content of the first set of programming instructions;

determine whether the content of the first set of programming instructions is logically valid, wherein if the content of the first set of programming instructions is not logically valid, refusing further receipt of the second set of programming instructions from the computing device until an indication that the computing device has been reset is received; and

transmit the first set of programming instructions to the medical device if the content of the first set of programming instructions is logically valid.