Heart failure patient management using an implantable monitoring system

• US 8,777,850 B2
• Filed: 10/31/2008
• Issued: 07/15/2014
• Est. Priority Date: 10/31/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Cho, Yong K., Manda, Ven R., Sparks, Brandon S., Bennett, Tommy D.
• Primary Examiner(s): Brown, Melanie Y
• Assistant Examiner(s): Crawford, Erik B
• Application Number:
  US12/262,254
• Publication Number:
  US 20100113890A1
• Time in Patent Office: 2,083 Days
• Field of Search: 128/905, 128/920, 128/923, 600/300, 600/301, 600481-487
• US Class Current: 600/300
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

An implantable medical device system and method provide physiological variable monitoring for use in patient management. A target value for a physiological variable and formulations for computing metrics of the physiological variable are stored. Values of the physiological variable are determined from a sensed physiological signal and are used to compute a selected metric. The metric is compared to the stored target value.

Claims

1. An implantable medical device, comprising;

a physiological sensor;

a memory storing a target value for a physiological variable and storing a plurality of formulations for computing a plurality of averaged metrics of the physiological variable;

a control unit configured for selecting a formulation for computing a first averaged metric of the plurality of averaged metrics and a second averaged metric of the plurality of averaged metrics from the plurality of formulations for computing a plurality of averaged metrics of the physiological variable, receiving a signal from the physiological sensor, computing the first averaged metric of the variable using the signal extending over a first periodic time interval and the second averaged metric of the variable using the signal extending over a second periodic time interval longer than and including the first periodic time interval such that the first and second averaged metrics provide different temporal resolutions of the physiological variable, and separately comparing each of the first averaged metric and the second averaged metric to the stored target value; and

a notification module configured for generating a notice in response to the comparisons of the computed metrics to the target value, wherein the memory stores the identity of the selected first averaged metric and the second averaged metric, and the notification module generates the notice in response to both the selected formulation and the comparison of the selected first averaged metric and the second averaged metric and the target value.

2. The device of claim 1 wherein each of the plurality of formulations correspond to a time interval for computing the metric, wherein at least one formulation corresponds to a first time interval and another formulation corresponds to a second time interval greater than the first time interval.

3. The device of claim 1 wherein the control unit computes updated values of one of the plurality of metrics, and

the notification module generates reports of the computed updated metric values at predetermined time intervals after generating the notice.

4. The device of claim 1 wherein the notice comprises a time interval since a previous notice.

5. The device of claim 3 wherein the notification module receives an intervention initiated message, and

the control unit sets an intervention started flag in response to the received message.

6. The device of claim 5 wherein the notification module receives an intervention stopped message and generates reports of the updated metric values at predetermined time intervals until the intervention stopped notice is received.

7. The device of claim 1 wherein the physiological sensor is a pressure sensor.

8. The device of claim 2 wherein the physiological variable is an estimated pulmonary artery diastolic pressure (ePAD).

9. The device of claim 8 wherein the plurality of formulations comprise a daily average ePAD, a weekly average ePAD, and an exponentially weighted weekly average ePAD.

10. The device of claim 8 wherein the target value is 22 mmHg.

11. The device of claim 1 wherein the target value comprises a magnitude and a time duration.

12. The device of claim 1 further comprising a second sensor sensing a signal for measuring a secondary variable having a secondary affect on the physiological variable, wherein the plurality of formulations comprise a first formulation for computing the selected metric at a first level of the secondary variable and a second formulation for computing the selected metric at a second level greater than the first level of the secondary variable.

13. The device of claim 12 wherein the secondary variable is one of heart rate, activity, respiration rate, posture, and time of day.

14. The device of claim 1 wherein the control unit determines the target value in response to the sensed physiological signal.

15. A method for use in an implantable medical device system, comprising;

storing a target value for a physiological variable;

storing a plurality of formulations for computing a plurality of averaged metrics of the physiological variable;

selecting a formulation for computing a first averaged metric of the plurality of averaged metrics and a second averaged metric of the plurality of averaged metrics from the plurality of formulations for computing a plurality of averaged metrics of the physiological variable;

sensing a physiological signal;

computing the first averaged metric of the variable using the signal extending over a first periodic time interval and the second averaged metric of the variable using the signal extending over a second periodic time interval longer than and including the first periodic time interval such that the first and second averaged metrics provide different temporal resolutions of the physiological variable;

separately comparing each of the first averaged metric and the second averaged metric to the stored target value; and

generating a notice in response to the comparisons of the computed metrics to the target value, wherein the notice is generated in response to both the selected formulation and the comparison of the selected first averaged metric and the second averaged metric and the target value.

16. The method of claim 15 wherein each of the plurality of formulations correspond to a time interval for computing the metric, wherein at least one formulation corresponds to a first time interval and another formulation corresponds to a second time interval greater than the first time interval.

17. The method of claim 15 further comprising computing updated values of one of the plurality of metrics;

and

generating a report of the computed updated metric values at predetermined time intervals after generating the notice.

18. The method of claim 15 wherein the notice comprises a time interval since a previous notice.

19. The method of claim 17 further comprising receiving an intervention initiated message, and

setting an intervention started flag in response to the received message.

20. The method of claim 19 further comprising:

receiving an intervention stopped message; and

generating the report at predetermined time intervals until the intervention stopped notice is received.

21. The method of claim 15 wherein the physiological signal is a pressure sensor.

22. The method of claim 21 wherein the physiological variable is an estimated pulmonary artery diastolic pressure (ePAD).

23. The method of claim 22 wherein the plurality of formulations comprise a daily average ePAD, a weekly average ePAD, and an exponentially weighted weekly average ePAD.

24. The method of claim 22 wherein the target value is 22 mmHg.

25. The method of claim 15 wherein the target value comprises a magnitude and a time duration.

26. The method of claim 15 further comprising:

sensing a signal for measuring a secondary variable having a secondary affect on the physiological variable,

wherein the plurality of formulations comprise a first formulation for computing the selected metric at a first level of the secondary variable and a second formulation for computing the selected metric at a second level greater than the first level of the secondary variable.

27. The method of claim 26 wherein the secondary variable is one of heart rate, activity, respiration rate, posture, and time of day.

28. The method of claim 15 further comprising determining the target value in response to the sensed physiological signal.

29. A non-transitory computer readable medium for storing a set of instructions which when implemented in an implantable medical device system cause the system to:

store a target value for a physiological variable;

store a plurality of formulations for computing a plurality of averaged metrics of the physiological variable;

selecting a formulation for computing a first averaged metric of the plurality of averaged metrics and a second averaged metric of the plurality of averaged metrics from the plurality of formulations for computing a plurality of averaged metrics of the physiological variable;

sense a physiological signal;

compute the first averaged metric of the variable using the signal extending over a first periodic time interval and the second averaged metric of the variable using the signal extending over a second periodic time interval longer than and including the first periodic time interval such that the first and second averaged metrics provide different temporal resolutions of the physiological variable;

separately compare each of the first averaged metric and the second averaged metric to the stored target value; and

generate a notice in response to the comparisons of the computed metrics to the target value, wherein the notice is generated in response to both the selected formulation and the comparison of the selected first averaged metric and the second averaged metric and the target value.