Stimulation mode determination

• US 9,504,835 B2
• Filed: 09/09/2014
• Issued: 11/29/2016
• Est. Priority Date: 06/15/2009
• Status: Active Grant

• Current Assignee: Sorin CRM SAS (MicroPort Scientific Corp.)
• Original Assignee: Sorin CRM SAS (MicroPort Scientific Corp.)
• Inventors: Graindorge, Laurence
• Primary Examiner(s): Lee, Erica
• Application Number:
  US14/480,855
• Publication Number:
  US 20140379040A1
• Time in Patent Office: 812 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance
• CPC Class Codes: A61N 1/36528 the parameter being measured by means of ultrasound
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood
• CPC Class Codes: A61N 1/36564 controlled by blood pressure
• CPC Class Codes: A61N 1/36578 controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3688 configured for switching the pacing mode, e.g. from AAI to DDD
• CPC Class Codes: A61N 1/3918 characterised by shock pathway, e.g. by electrode configuration
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: G06T 15/04 Texture mapping

Abstract

Devices and methods for providing pacing in multiple modes are provided. One device operates in a dual chamber (DDD or biventricular) mode and in a pacing mode favoring the spontaneous atrioventricular conduction such as an AAI mode (10) with a ventricular sensing or a mode with hysteresis of the atrioventricular delay. The device controls (10-18) the conditional switching from one mode to the other. The device comprises a hemodynamic sensor, including an endocardial acceleration sensor, derives a hemodynamic index representative of the hemodynamic tolerance of the patient to the spontaneous atrioventricular conduction. The device controls inhibiting or (20) forcing the conditional switching of the device to the DDD (or biventricular) mode according to the evolution of the hemodynamic index.

Claims

1. An active implantable medical device for stimulation, resynchronization and/or defibrillation of a patient, comprising:

a hemodynamic sensor configured to generate an output signal; and

one or more circuits configured to;

switch the implantable medical device between a single chamber mode of stimulation and a dual chamber mode of stimulation;

measure the atrioventricular delay between an atrial pacing event and a spontaneous ventricular depolarization after the atrial pacing event;

determine whether the atrioventricular delay exceeds a threshold atrioventricular delay; and

in response to the atrioventricular delay exceeding the threshold atrioventricular delay;

derive from the output signal of the hemodynamic sensor a hemodynamic index representative of a patient'"'"'s tolerance to the atrioventricular delay that exceeds the threshold atrioventricular delay, wherein the one or more circuits are configured to utilize output data from the hemodynamic sensor associated with a single cardiac cycle to derive the hemodynamic index; and

determine whether to activate or deactivate the dual chamber mode based on the hemodynamic index.

2. The device of claim 1, wherein the one or more circuits are further configured to:

diagnose an occurrence of an atrioventricular block; and

activate the dual chamber mode in the absence of the atrioventricular block.

3. The device of claim 1, wherein the threshold atrioventricular delay comprises a variable threshold, depending on the heart rate of the patient, and the one or more circuits are configured to dynamically reduce a value of the variable threshold when the current heart rate is increased.

4. The device of claim 1, wherein the one or more circuits are configured to:

detect of a state of patient effort; and

force a switch to the dual chamber mode and inhibit a return back to the single chamber mode until the device detects the state of patient effort.

5. The device of claim 1, wherein the one or more circuits are configured to determine whether to activate or deactivate the dual chamber mode by:

comparing a current value of the hemodynamic index to a reference hemodynamic index; and

activating the dual chamber mode when the current value of the hemodynamic index is less than the reference hemodynamic index.

6. The device of claim 5, wherein the value of the reference hemodynamic index is a variable value depending on the heart rate of the patient, and the one or more circuits are configured to dynamically increase the value of the reference hemodynamic index when the current heart rate is increased.

7. The device of claim 6, wherein the value of the reference hemodynamic index is a variable value between a minimum limit and a maximum limit, and the one or more circuits are configured to dynamically update the minimum and maximum limits.

8. The device of claim 5, wherein the one or more circuits are configured to:

determine an occurrence of a permanent atrioventricular block; and

set the reference hemodynamic index to a value independent of the heart rate in the presence of the determined permanent atrioventricular block.

9. The device of claim 1, wherein the hemodynamic sensor further comprises a sensor selected from among the group consisting of an endocardial acceleration sensor, an epicardial acceleration sensor, a myocardium wall motion sensor, an intracardiac pressure sensor, an intracardiac bioimpedance sensor, an optical sensor measuring oxygen saturation, and a sensor for measuring a change in volume by ultrasounds.

10. The device of claim 9, wherein the hemodynamic sensor is a hemodynamic endocardial acceleration sensor configured to generate the output signal representative of the movements produced by cyclical contractions of a myocardium.

11. The device of claim 10, wherein the one or more circuits are configured to:

recognize and isolate in the output signal a component corresponding to a peak endocardial acceleration associated with a ventricular contraction; and

derive the hemodynamic index from the component.

12. The device of claim 10, wherein the one or more circuits are configured to:

recognize and isolate in the output signal delivered by the hemodynamic sensor at least two components corresponding to two respective peaks of endocardial acceleration associated with the ventricular contraction; and

derive the hemodynamic index from a time interval separating the at least two components.

13. An implantable medical device comprising:

a hemodynamic sensor configured to generate an output signal, wherein the hemodynamic sensor comprises an electronic sensor configured to measure a value representative of a property of at least one of;

heart tissue;

or

blood flowing through a heart or blood vessels proximate to the heart; and

one or more circuits configured to;

switch the implantable medical device between a single chamber mode of stimulation and a dual chamber mode of stimulation;

measure the atrioventricular delay between an atrial pacing event and a spontaneous ventricular depolarization after the atrial pacing event;

determine whether the atrioventricular delay exceeds a threshold atrioventricular delay; and

in response to the atrioventricular delay exceeding the threshold atrioventricular delay;

derive from the output signal of the hemodynamic sensor a hemodynamic index representative of a patient'"'"'s tolerance to the atrioventricular delay that exceeds the threshold atrioventricular delay; and

determine whether to activate or deactivate the dual chamber mode based on the hemodynamic index.

14. The device of claim 13, wherein the hemodynamic sensor is configured to measure one or more of an endocardial acceleration value, an epicardial acceleration value, a myocardium wall motion value, an intracardiac pressure value, an intracardiac bioimpedance value, an oxygen saturation value, or a volume change value.

15. The device of claim 13, wherein the threshold atrioventricular delay comprises a variable threshold, depending on the heart rate of the patient, and the one or more circuits are configured to dynamically reduce a value of the variable threshold when the current heart rate is increased.

16. The device of claim 13, wherein the one or more circuits are configured to determine whether to activate or deactivate the dual chamber mode by:

comparing a current value of the hemodynamic index to a reference hemodynamic index; and

activating the dual chamber mode when the current value of the hemodynamic index is less than the reference hemodynamic index.

17. The device of claim 16, wherein the value of the reference hemodynamic index is a variable value depending on the heart rate of the patient, and the one or more circuits are configured to dynamically increase the value of the reference hemodynamic index when the current heart rate is increased.

18. The device of claim 17, wherein the one or more circuits are configured to:

determine an occurrence of a permanent atrioventricular block; and

set the reference hemodynamic index to a value independent of the heart rate in the presence of the determined permanent atrioventricular block.

19. The device of claim 13, wherein the hemodynamic sensor is a hemodynamic endocardial acceleration sensor configured to generate the output signal representative of the movements produced by cyclical contractions of a myocardium.

20. The device of claim 19, wherein the one or more circuits are configured to:

recognize and isolate in the output signal a component corresponding to a peak endocardial acceleration associated with a ventricular contraction; and

derive the hemodynamic index from the component.

21. A method comprising:

switching an implantable medical device between a single chamber mode of stimulation and a dual chamber mode of stimulation;

determining whether an atrioventricular delay between an atrial pacing event and a spontaneous ventricular depolarization after the atrial pacing event exceeds a threshold atrioventricular delay; and

in response to the atrioventricular delay exceeding the threshold atrioventricular delay, determining whether to activate or deactivate the dual chamber mode using a hemodynamic sensor comprising an electronic sensor configured to measure a value representative of a property of at least one of heart tissue or blood flowing through a heart or blood vessels proximate to the heart, the step of determining whether to activate or deactivate the dual chamber mode comprising;

deriving from an output signal of the hemodynamic sensor a hemodynamic index representative of a patient'"'"'s tolerance to the atrioventricular delay; and

determining whether to activate or deactivate the dual chamber mode based on the hemodynamic index.

22. The method of claim 21, further comprising:

determining, over a plurality of atrial events, whether an amount of atrial events that are not followed by a detected ventricular event exceeds a threshold; and

in response to the number of atrial events that are not followed by a detected ventricular event exceeding the threshold, activating the dual chamber mode;

the steps of determining whether the atrioventricular delay exceeds the threshold atrioventricular delay and determining whether to activate or deactivate the dual chamber mode performed in response to the number of atrial events that are not followed by a detected ventricular event not exceeding the threshold.

23. The method of claim 21, the step of deriving the hemodynamic index comprising deriving the hemodynamic index based on output data from the hemodynamic sensor associated with a single cardiac cycle.

24. The method of claim 21, wherein the threshold atrioventricular delay comprises a variable threshold, depending on the heart rate of the patient, and the method further comprises dynamically reducing a value of the variable threshold when the current heart rate is increased.

25. The method of claim 21, the step of determining whether to activate or deactivate the dual chamber mode comprising:

comparing a current value of the hemodynamic index to a reference hemodynamic index; and

activating the dual chamber mode when the current value of the hemodynamic index is less than the reference hemodynamic index.

26. The method of claim 25, wherein the value of the reference hemodynamic index is a variable value depending on the heart rate of the patient, and the method further comprises dynamically increasing the value of the reference hemodynamic index when the current heart rate is increased.

27. The method of claim 26, further comprising:

determining an occurrence of a permanent atrioventricular block; and

setting the reference hemodynamic index to a value independent of the heart rate in the presence of the determined permanent atrioventricular block.