Medical device system having an implanted medical device and an external device

• US 9,486,153 B2
• Filed: 02/01/2016
• Issued: 11/08/2016
• Est. Priority Date: 06/17/2010
• Status: Active Grant

• Current Assignee: Angel Medical Systems, Inc.
• Original Assignee: Angel Medical Systems, Inc.
• Inventors: Keenan, David, John, Michael Sasha
• Primary Examiner(s): FAIRCHILD, MALLIKA DIPAYAN
• Application Number:
  US15/011,883
• Publication Number:
  US 20160143533A1
• Time in Patent Office: 281 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/333 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/7221 Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• 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: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Disclosed is a system having an implanted component and external component which are configured to provide a test of wireless communication in order to assess the success or failure of such communication and to store attributes related to such test in a memory log. To provide the communication test the implantable and external components can attempt wireless communication according to communication test parameters which relate to number of times to retry communication, duration of sending communication test signals, durations of waiting for communication test signals and the schedule of the communication tests. The schedule of tests may be period or may change over time in order to become more or less frequency according to a programmable schedule that may also decrease if the communication tests are successful and indicate patient compliance in keeping the external components close by. The communication tests can assist in determining if the patient is maintaining external components within a suggested proximity (e.g. 6 feet) of the patient and may assist to determine if transmission or reception difficulties are the source of communication failure. A physician programmer can provide for programming, conducting, summarizing and assessing the results of communication tests.

Claims

1. A medical device system, the system comprising:

an implanted medical device, and

an external device comprising a transceiver, a random access memory, and a processor coupled to the transceiver and the random access memory, wherein the processor is configured to;

periodically activate wireless communication circuitry in an attempt to communicate a plurality of proximity test signals with the implanted medical device;

for each of the plurality of activations, determine whether a proximity signal has been received from the implanted device within a certain time after the activation, thereby generating a plurality of proximity test receipt results;

apply a test to the plurality of proximity test receipt results to determine whether a proximity failure condition exists, thereby generating a plurality of proximity test results;

operative when a proximity failure condition exists, take at least one of the following actions;

store information regarding the proximity failure in the random access memory or send a proximity test failure condition notification; and

when the proximity failures in the random access memory meet a selected first proximity test criterion, the processor is further configured to send notification to the patient.

2. The medical device system according to claim 1 wherein the processor is further configured to send notification to a remote station when the proximity failures in the random access memory meet a selected second proximity test criterion.

3. The medical device system according to claim 1 wherein the periodic activation occurs every 24 hours.

4. The medical device system of claim 1 further including a proximity test module which operates upon the random access memory to provide a log of the plurality of proximity test results including a time of each test and a quantitative value related to a strength of each of the plurality of the proximity test signals.

5. The medical device system of claim 1 further including a proximity test module which operates upon the random access memory to provide a log of the plurality of proximity test results including a time of each test and a qualitative value related to a quality of each of the plurality of the proximity test signals.

6. The medical device system of claim 1 wherein the implantable medical device is configured to provide a proximity test in conjunction with the external device and to derive and store a second plurality of proximity test results.

7. The medical device system of claim 6 further including a programmer device configured for downloading the second plurality of proximity test results from the implanted device and processing these test results to provide a test result profile.

8. The medical device system of claim 6 further including a programmer device configured for downloading the second plurality of proximity test results from the implanted device and presenting the test results graphically to a user.

9. The medical device system of claim 6 further including a programmer configured for running a diagnostic protocol which causes at least one of the implanted device and external device to perform selected proximity tests according to a diagnostic protocol, and to evaluate the second plurality of proximity test results.

10. The medical device system of claim 6 further including a programmer device configured for downloading the second plurality of proximity test results of the implanted device and presenting the test results graphically to a user.

11. The medical device system of claim 1 further including a programmer device configured for downloading the plurality of proximity test results of the external device and processing these test results to provide a test result profile.

12. The medical device system of claim 1 further including a programmer configured for running a diagnostic protocol which causes the external device to perform selected proximity tests according to a diagnostic protocol, and to evaluate the plurality of proximity test results.

13. The medical device system of claim 1 further including a programmer configured for running a diagnostic protocol which causes the external device to perform selected proximity tests according to a diagnostic protocol, and to display the plurality of proximity test results.

14. The medical device system of claim 1 wherein the periodic activation of the wireless communication circuitry in an attempt to communicate a plurality of proximity test signals with the implanted medical device, includes operating the wireless communication circuitry to receive a plurality of proximity test signals transmitted by the implanted medical device.

15. The medical device system of claim 1 wherein the periodic activation of the wireless communication circuitry in an attempt to communicate a plurality of proximity test signals with the implanted medical device, includes operating the wireless communication circuitry to send a plurality of proximity test signals which are designed to be received by the implanted medical device.

16. The medical device system according to claim 1 wherein the periodic activation occurs as a function of the plurality of proximity test results so that the plurality of proximity test results are used to adjust the schedule of proximity testing.

17. The medical device system according to claim 1 wherein the periodic activation occurs as a function of the plurality of proximity test results.

18. The medical device system according to claim 1 wherein the periodic activation occurs as a function of the plurality of proximity test results and according to a programmable schedule that decreases when the communication tests are successful, thereby indicating patient compliance in keeping the external device sufficiently close to the patient wherein the tests are successful.

19. A medical device system, the system comprising:

an implanted medical device, and

an external device comprising a transceiver, a random access memory, and a processor coupled to the transceiver and the random access memory, wherein the processor is configured to;

periodically activate wireless communication circuitry in an attempt to communicate a plurality of proximity test signals with the implanted medical device;

for each of the plurality of activations, determine whether a proximity signal has been received from the implanted device within a certain time after the activation, thereby generating a plurality of proximity test receipt results;

apply a test to the plurality of proximity test receipt results to determine whether a proximity failure condition exists, thereby generating a plurality of proximity test results;

operative when a proximity failure condition exists, take at least one of the following actions;

store information regarding the proximity failure in the random access memory or send a proximity test failure condition notification; and

when the proximity failures in the random access memory meet a selected proximity test criterion, the processor is further configured to send notification to a remote station.

20. A medical device system, the system comprising:

an implanted medical device, and

an external device comprising a transceiver, a random access memory, and a processor coupled to the transceiver and the random access memory, wherein the processor is configured to;

periodically activate wireless communication circuitry to transmit a plurality of proximity test signals with the implanted medical device;

when the external device receives an acknowledge signal from said implanted medical device responsive to at least one proximity test signal, the processor stores the acknowledge signal and generates a proximity test receipt result indicating that both the proximity test signal and the acknowledgement signal were received;

when the external device does not receive an acknowledge signal from said implanted medical device responsive to at least one proximity test signal, the processor is further configured to store the proximity test signal and generate a proximity test receipt result indicating that there was no acknowledge signal sent from the implanted medical device defining a proximity failure; and

,

when a plurality of proximity failures stored in the random access memory meets a selected proximity test criteria, the processor is further configured to document said test receipt results, whereby a patient or caregiver is notified as to compliance or non-compliance of the patient with maintaining the implanted medical device within a predetermined proximity of the external device.