Implanted lead analysis system and method

• US 9,440,088 B2
• Filed: 12/06/2013
• Issued: 09/13/2016
• Est. Priority Date: 12/06/2012
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Perschbacher, David L., Mahajan, Deepa, Sharma, Arjun D., Marshik, Jeffry V.
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US14/099,381
• Publication Number:
  US 20140163629A1
• Time in Patent Office: 1,012 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

The technology disclosed herein relates to a method for lead analysis for an implanted medical device. A summary data record is retrieved associated with one or more episodes from an implanted medical device through a communication module. Episode selection criteria are applied to the summary data record by a processing module. One or more episode data records are retrieved from the implanted medical device for one or more episodes for which the episode selection criteria was satisfied. Noise detection criteria are applied to the episode data record. A notification module is configured to generate an alert if the noise detection criteria are satisfied.

Claims

1. An external device for determining a lead-related condition associated with an implantable medical device (IMD) capable of being implanted in a patient:

(a) a communication module configured to retrieve patient data from an IMD, wherein the patient data comprises at least episode data records each associated with an episode and a summary data record corresponding to one or more episodes;

(b) a processing module configured to execute rapid sensing analysis comprising;

(i) initiate periodic retrieval of a summary data record by the communication module from the IMD;

(ii) apply an episode selection criteria to the summary data record to identify one or more episodes of interest,

(iii) initiate retrieval from the IMD by the communication module of one or more episode data records associated with each episode of interest, and

(iv) apply noise detection criteria to the one or more episode data records; and

(c) a notification module configured to generate an alert if the noise detection criteria are satisfied.

2. The device of claim 1 wherein each summary data record of the one or more summary data records comprises a shock indicator indicating whether a shock was delivered by the IMD for a particular episode and the episode selection criteria excludes episodes during which a shock was delivered by the IMD.

3. The device of claim 1 wherein the processing module is configured to apply episode selection criteria to each summary data record comprising whether the episode was sustained and whether a shock was delivered.

4. The device of claim 3, wherein the processing module is configured to apply episode selection criteria to each summary data record comprising a therapy indicator indicating whether no therapy was attempted and whether anti-tachycardia pacing (ATP) was delivered by the IMD.

5. The device of claim 4, wherein the processing module is configured such that the episode selection criteria are satisfied if ATP was delivered during an episode.

6. The device of claim 3, wherein the processing module is configured such that the episode selection criteria are satisfied if an episode was sustained absent a delivered shock.

7. The device of claim 1 wherein the processing module is configured to apply noise detection criteria comprising first noise sub-criteria and second noise sub-criteria, and the noise detection criteria are satisfied if either the first or second noise sub-criteria are satisfied.

8. The device of claim 7 wherein:

the first noise sub-criteria are satisfied if episodes with ATP delivered or episodes with a diverted shock are determined to contain noise based on applying a noise definition; and

the second noise sub-criteria are satisfied if sustained episodes with no therapy attempted on two different days within a first time period are determined to contain noise based on applying the noise definition.

9. The device of claim 8 wherein the noise definition is satisfied if there are a threshold number of ventricular sensed beats that satisfy a first fast interval threshold.

10. The device of claim 9 wherein the threshold number of ventricular sensed beats is four.

11. The device of claim 1, wherein the processing module is further configured to execute an impedance spike analysis comprising:

determination of an impedance median;

identification of a number of impedance spikes relative to the median; and

notification if the number of impedance spikes is more than a spike threshold.

12. The device of claim 11, further comprising a user interface to optionally select each of impedance spike analysis and rapid sensing analysis.

13. The device of claim 1 further comprising a memory configured to store retrieved summary data records, store retrieved episode data records, store outcomes of the application of noise detection criteria to retrieved episode data records and store alert notification records.

14. A method for lead analysis for an implanted medical device (IMD) comprising:

(a) retrieving a summary data record associated with one or more episodes from an IMD through a communication module;

(b) applying episode selection criteria to the summary data record by a processing module;

(c) retrieving one or more episode data records from the IMD for one or more episodes for which the episode selection criteria was satisfied;

(d) applying noise detection criteria to the episode data record; and

(e) generating an alert if the noise detection criteria are satisfied.

15. The method of claim 14 wherein the summary data record includes a shock indicator indicating whether a shock was delivered by the IMD and wherein the episode selection criteria excludes episodes during which a shock was delivered by the IMD.

16. The method of claim 14 wherein applying episode selection criteria to the summary data record comprises determining whether the episode was sustained, whether shock was delivered, and whether anti-tachycardia pacing (ATP) was delivered by the IMD.

17. The method of claim 16, wherein the episode selection criteria are satisfied if ATP was delivered during an episode.

18. The method of claim 16, wherein the episode selection criteria are satisfied if an episode was sustained absent a delivered shock.

19. The method of claim 14, further comprising executing an impedance spike analysis comprising:

determining an impedance median;

identifying a number of impedance spikes relative to the median; and

notifying if the number of impedance spikes is more than a spike threshold.

20. An external device for determining a lead-related condition associated with an implantable medical device (IMD) capable of being implanted in a patient:

(a) a communication module configured to retrieve patient data from an IMD, wherein the patient data comprises at least one or more episode data records each associated with an episode and a summary data record;

(b) a processing module configured to execute rapid sensing analysis comprising;

(i) initiate periodic retrieval of a summary data record by the communication module from the IMD;

(ii) apply an episode selection criteria to the retrieved summary data record to identify one or more episodes of interest,

(iii) initiate retrieval from the IMD by the communication module of one or more episode data records associated with each episode of interest, and

(iv) apply noise detection criteria to the one or more episode data record or records; and

(c) a notification module configured to generate an alert if the noise detection criteria are satisfied;

wherein each summary data record includes a shock indicator indicating whether a shock was delivered by the IMD for a particular episode and the episode selection criteria excludes episodes during which a shock was delivered by the IMD.