Rate responsive cardiac pacing control using posture

• US 9,937,352 B2
• Filed: 10/22/2015
• Issued: 04/10/2018
• Est. Priority Date: 10/22/2015
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sheldon, Todd J, Demmer, Wade M, Williams, Eric R
• Primary Examiner(s): Johnson, Nicole F
• Application Number:
  US14/920,228
• Publication Number:
  US 20170113051A1
• Time in Patent Office: 901 Days
• Field of Search: 607 9, 607 18
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1121 Determining geometric values, e.g. centre of rotation or angular range of movement
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61N 1/36535 controlled by body position or posture
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

An implantable rate responsive pacemaker includes a sensor module configured to produce an activity signal correlated to a metabolic demand of a patient and a posture signal correlated to patient posture. The pacemaker further includes a pulse generator configured to generate and deliver pacing pulses to a patient'"'"'s heart via a pair of electrodes coupled to the pacemaker. A control module is coupled to the pulse generator and the sensor module and is configured to determine a sensor indicated pacing rate from the activity signal, compare the posture signal to verification criteria for confirming an exercising posture of the patient, and withhold an adjustment of a pacing rate to the sensor indicated pacing rate responsive to the verification criteria not being met.

Claims

1. A method for controlling a pacing rate for a rate responsive implantable pacemaker, the method comprising:

sensing an activity signal correlated to a metabolic demand of a patient;

determining a sensor indicated pacing rate (SIR) based on the activity signal;

sensing a posture signal correlated to a physical body posture of the patient;

comparing the posture signal to one or more verification criteria correlated to an exercising posture of the patient; and

withholding an adjustment of the pacing rate to be the SIR in response to the one or more verification criteria not being met.

2. The method of claim 1, wherein withholding the adjustment of the pacing rate to be the SIR comprises setting the pacing rate to a rate that is not correlated to the activity signal.

3. The method of claim 1, further comprising:

comparing the SIR to a rate threshold, and

comparing the posture signal to the one or more verification criteria only in response to the SIR being greater than the rate threshold.

4. The method of claim 1, wherein withholding the adjustment of the pacing rate to be the SIR comprises setting the pacing rate to a base pacing rate.

5. The method of claim 1, wherein the activity signal and the posture signal are sensed from a multi-axis accelerometer, the method further comprising:

establishing a first axis of the multi-axis accelerometer as an activity signal axis for sensing the activity signal; and

establishing a second axis of the multi-axis accelerometer as a posture signal axis for sensing the posture signal.

6. The method of claim 5, wherein establishing the second axis comprises:

determining a DC signal of each axis of the multi-axis accelerometer during a known patient posture; and

selecting the posture signal axis as one of the axes of the multi-axis accelerometer having the DC signal closest to a positive or negative 1 G acceleration.

7. The method of claim 5, wherein establishing the first axis comprises:

determining a resting activity metric from each axis of the multi-axis accelerometer during a first patient posture while the patient is at rest;

determining an exercising activity metric from each axis of the multi-axis accelerometer during the first patient posture while the patient is exercising;

determining a difference between the resting activity metric and the exercising activity metric for each axis; and

selecting the activity signal axis as one of the axes of the multi-axis accelerometer having at least one of a lowest resting activity metric or a greatest difference between the resting activity metric and the exercising activity metric.

8. The method of claim 5, further comprising:

establishing the second axis of the multi-axis accelerometer by identifying an axis of the multi-axis accelerometer having a DC signal nearest to a positive or negative acceleration of 1 G responsive to the patient being in an upright posture; and

setting the one or more verification criteria correlated to the exercising posture of the patient based on the DC signal of the second axis that is received responsive to the patient being in the upright posture.

9. The method of claim 1, wherein the activity signal and the posture signal are sensed from a multi-axis accelerometer, wherein the pacemaker includes the multi-axis accelerometer, the method further comprising:

establishing a first activity signal axis of the multi-axis accelerometer for monitoring patient activity corresponding to a first patient posture;

establishing a first posture signal axis of the multi-axis accelerometer for detecting the first patient posture;

establishing a second activity signal axis of the multi-axis accelerometer for monitoring patient activity corresponding to a second patient posture;

establishing a second posture signal axis of the multi-axis accelerometer for detecting the second patient posture;

determining a first SIR based on the first activity signal axis;

comparing the first SIR to a first rate threshold;

in response to the first SIR being greater than the first rate threshold, comparing a signal from the first posture signal axis to a first posture verification criterion of the one or more verification criteria correlated to the exercising posture of the patient;

determining a second SIR based on the second activity signal axis;

comparing the second SIR to a second rate threshold;

in response to the second SIR being greater than the second rate threshold, comparing a signal from the second posture signal axis to a second posture verification criterion of the one or more verification criteria correlated to the exercising posture of the patient;

setting the pacing rate based on one of the first SIR or the second SIR in response to one of the signal from the first posture signal axis meeting the first posture verification criterion or the signal from the second posture signal axis meeting the second posture verification criterion; and

setting the pacing rate to a rate that is not correlated to the first SIR and not correlated to the second SIR in response to the signal from first posture signal axis not meeting the first posture verification criterion and the signal from the second posture signal axis not meeting the second posture verification criterion.

10. The method of claim 9, further comprising:

comparing the second SIR to the second rate threshold in response to the first SIR being greater than the first rate threshold and the signal from the first posture signal axis not meeting the first posture verification criterion.

11. An implantable rate responsive pacemaker, comprising:

a sensor module configured to produce an activity signal correlated to a metabolic demand of a patient and a posture signal correlated to patient posture;

a pulse generator configured to generate and deliver pacing pulses to a patient'"'"'s heart at a pacing rate via a pair of electrodes coupled to the pacemaker; and

a control module coupled to the pulse generator and the sensor module and configured to;

determine a sensor indicated pacing rate (SIR) based on the activity signal;

compare the posture signal to one or more verification criteria correlated to an exercising posture of the patient; and

withhold an adjustment of the pacing rate to be the SIR in response to the one or more verification criteria not being met.

12. The pacemaker of claim 11, wherein the control module is further configured to withhold the adjustment of the pacing rate to be the sensor indicated pacing rate by setting the pacing rate to a rate that is not correlated to the activity signal.

13. The pacemaker of claim 11, wherein the control module is further configured to:

compare the SIR to a rate threshold, and

compare the posture signal to the one or more verification criteria only in response to the SIR being greater than the rate threshold.

14. The pacemaker of claim 11, wherein the control module is further configured to adjust the pacing rate to be the SIR in response to the one or more verification criteria being met.

15. The pacemaker of claim 13, wherein the control module is configured to withhold the adjustment to the sensor indicated pacing rate by setting the pacing rate to the rate threshold.

16. The pacemaker of claim 11, wherein the control module is further configured to withhold the adjustment to the sensor indicated pacing rate by setting the pacing rate to a base pacing rate.

17. The pacemaker of claim 11, wherein the sensor module comprises a multi-axis accelerometer, the control module further configured to:

establish a first axis of the multi-axis accelerometer as an activity signal axis for sensing the activity signal; and

establish a second axis of the multi-axis accelerometer as a posture signal axis for sensing the posture signal.

18. The pacemaker of claim 17, wherein the control module is configured to establish the second axis by at least:

determining a DC signal of each axis of the multi-axis accelerometer during a known patient posture; and

selecting the posture signal axis as one of the axes of the multi-axis accelerometer having the respective DC signal closest to a positive or negative 1 G acceleration.

19. The pacemaker of claim 17, wherein the control module is configured to establish the first axis by at least:

determining a resting activity metric from each axis of the multi-axis accelerometer during a first patient posture while the patient is at rest;

determining an exercising activity metric from each axis of the multi-axis accelerometer during the first patient posture while the patient is exercising;

determining a difference between the resting activity metric and the exercising activity metric for each axis; and

selecting the activity signal axis as one of the axes of the multi-axis accelerometer having at least one of a lowest resting activity metric or a greatest difference between the resting activity metric and the exercising activity metric.

20. The pacemaker of claim 17, wherein the control module is further configured to:

establish the second axis of the multi-axis accelerometer by identifying an axis of the multi-axis accelerometer having a DC signal nearest to a positive or negative acceleration of 1 G responsive to the patient being in an upright posture; and

set the one or more verification criteria based on the DC signal of the second axis that is received responsive to the patient being in the upright posture.

21. The pacemaker of claim 11, wherein:

the sensor module comprises a multi-axis accelerometer; and

the control module is further configured to;

establish a first activity signal axis of the multi-axis accelerometer for monitoring patient activity corresponding to a first patient posture;

establish a first posture signal axis of the multi-axis accelerometer for detecting the first patient posture;

establish a second activity signal axis of the multi-axis accelerometer for monitoring patient activity corresponding to a second patient posture;

establish a second posture signal axis of the multi-axis accelerometer for detecting the second patient posture;

determine a first SIR based on the first activity signal axis;

compare the first SIR to a first rate threshold;

in response to the first SIR being greater than the first rate threshold, compare a signal from the first posture signal axis to first posture verification criterion of the more or more verification criteria correlated to the exercising posture of the patient;

determine a second SIR based on the second activity signal axis;

compare the second SIR to a second rate threshold;

in response to the second SIR being greater than the second rate threshold, compare a signal from the second posture signal axis to a second posture verification criterion of the more or more verification criteria correlated to the exercising posture of the patient;

set a pacing rate based on at least one of the first SIR and the second SIR in response to at least one of the signal from the first posture signal axis meeting the first posture verification criterion and the signal from the second posture signal axis meeting the second posture verification criterion; and

set the pacing rate to a rate that is not correlated to the first SIR and not correlated to the second SIR in response to the signal from the first posture signal axis not meeting the first posture verification criterion and the signal from the second posture signal axis not meeting the second posture verification criterion.

22. The pacemaker of claim 21, wherein the control module is further configured to compare the second SIR to the second rate threshold in response to the first SIR being greater than the first rate threshold and the signal from the first posture signal axis not meeting the first posture verification criterion.

23. The pacemaker of claim 11, further comprising a housing enclosing the sensor module, the control module and the pulse generator,

the housing carrying the electrodes coupled to the pulse generator,

the pacemaker being an intracardiac pacemaker and the electrodes being intracardiac electrodes.

24. A non-transitory, computer readable storage medium storing a set of instructions that, when executed by a control module of an implantable pacemaker, cause the pacemaker to:

determine a sensor indicated pacing rate (SIR) based on an activity signal correlated to a metabolic demand of a patient received by the control module from a sensor module;

compare a posture signal received by the control module from the sensor module to one or more posture verification criteria correlated to an exercising posture of the patient; and

withhold an adjustment of a pacing rate to be the SIR in response to the one or more posture verification criteria not being met.