Cardiac function management integrating cardiac contractility modulation

• US 8,718,761 B2
• Filed: 09/16/2009
• Issued: 05/06/2014
• Est. Priority Date: 09/16/2008
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Stahmann, Jeffrey E.
• Primary Examiner(s): Koharski, Christopher
• Assistant Examiner(s): VOORHEES, CATHERINE M
• Application Number:
  US12/561,143
• Publication Number:
  US 20100069985A1
• Time in Patent Office: 1,693 Days
• Field of Search: 607/9, 607 17- 18, 607/29, 607/46, 600/411, 600/484, 600/529
• US Class Current: 607/9
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• 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 1/3686 configured for selecting the electrode configuration on a lead A61N1/3688 takes precedence
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/3708 for power depletion
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

An implantable cardiac rhythm/function management system integrates cardiac contractility modulation (CCM) and one or more other therapies, such as to preserve device safety, improve efficacy, enhance sensing and detection, or enhance therapy effectiveness and delivery. Examples of the one or more other therapies can include pacing, defibrillation/cardioversion, cardiac resynchronization therapy (CRT), or neurostimulation.

Claims

1. An apparatus comprising:

an implantable cardiac rhythm/function management device comprising;

a cardiac contractility modulation (CCM) therapy circuit configured to deliver a CCM therapy including a non-stimulatory electrical energy during a refractory period of the heart;

an adverse event detector circuit including a CCM stressor detector circuit configured to detect a CCM stressor condition for disabling the CCM therapy, wherein the CCM stressor condition includes a detection of sleep disordered breathing; and

a controller circuit, coupled to the CCM therapy circuit and the adverse event detector circuit, the controller circuit configured to obtain or provide information about a CCM condition and information about an adverse event, the controller circuit configured to adjust the CCM therapy using the information about the adverse event from the adverse event detector circuit, wherein the controller circuit is configured to disable the CCM therapy when or the sleep disordered breathing is detected.

2. The apparatus of claim 1, comprising a plurality of batteries and a non-CCM therapy circuit configured to deliver non-CCM therapy;

wherein the adverse event detector circuit comprises a battery status circuit configured to determine battery status information; and

wherein the controller circuit is configured to use the battery status information obtained from the battery status circuit to reconfigure which at least one of the plurality of batteries services at least one of the non-CCM therapy circuit or the CCM therapy circuit.

3. The apparatus of claim 1, comprising a non-CCM therapy circuit configured to deliver non-CCM therapy;

wherein the adverse event detector circuit comprises a battery status circuit configured to determine battery status information; and

wherein the controller circuit is configured to use the battery status information obtained from the battery status circuit to preferentially terminate delivery of one of the CCM therapy or the non-CCM therapy over the other of the CCM therapy or the non-CCM therapy.

4. The apparatus of claim 1, comprising a neurostimulation therapy circuit configured to deliver neurostimulation therapy;

wherein the adverse event detector circuit is configured to detect an adverse event associated with at least one of neurostimulation or CCM; and

wherein the controller circuit is configured to adjust at least one of the CCM therapy or the neurostimulation therapy based on the information from the adverse event detector circuit.

5. The apparatus of claim 4, wherein the controller circuit is configured such that when neurostimulation is enabled and an adverse event associated with the neurostimulation occurs, then the controller circuit (a) turns off neural stimulation when the CCM therapy is enabled;

(b) enables the CCM therapy when the CCM therapy is not enabled and does not disable neural stimulation;

or (c) enables the CCM therapy when the CCM therapy is not enabled and disables neural stimulation.

6. The apparatus of claim 4, wherein the controller circuit is configured such that when the CCM therapy is enabled and an adverse event associated with the CCM therapy occurs, then the controller circuit (a) turns off the CCM therapy when neurostimulation is enabled;

(b) turns on neurostimulation when neurostimulation is not enabled and does not disable the CCM therapy;

or (c) enables neurostimulation when neurostimulation is not enabled and disables the CCM therapy.

7. The apparatus of claim 1 wherein the adverse event detector circuit comprises a physiologic sensor.

8. The apparatus of claim 7, wherein the physiologic sensor is configured to detect pulsus alternans;

and

wherein the controller is configured to coordinate the CCM therapy circuit to adjust at least one of CCM energy, CCM delivery timing, CCM delivery location, or CCM electrode configuration in response to the detection of pulsus alternans.

9. The apparatus of claim 8, wherein the controller is configured to coordinate the CCM therapy circuit to increase at least one of CCM energy or frequency of CCM delivery in response to the detection of pulsus alternans.

10. The apparatus of claim 1, wherein the adverse event detector circuit comprises a user interface to receive user-input information about the adverse event.

11. The apparatus of claim 1, wherein the adverse event detector circuit comprises:

a CCM trigger detector circuit configured to detect a CCM trigger condition for enabling the CCM therapy; and

wherein the controller circuit is configured to enable the CCM therapy when at least one CCM trigger is detected.

12. The apparatus of claim 11, wherein the CCM trigger condition includes at least one of:

an indication of worsening heart failure, an indication of worsening kidney function, an indication of worsening hemodynamic status, an indication of a measure of a physiological parameter that is above or below a specified value range, an indication of dyspnea, a detected physical activity level that is below a specified threshold value, or an indication of an enabling or disabling of a device-based heart failure therapy other than CCM therapy.

13. The apparatus of claim 11, wherein the CCM trigger condition includes at least one of:

(1) an indication of worsening heart failure, or (2) an indication of an enabling or disabling of a device-based heart failure therapy other than CCM therapy.

14. The apparatus of claim 1, wherein the CCM stressor condition further includes at least one of:

a detected myocardial ischemia, a detected myocardial infarction, an indication of improving heart failure status, an indication of a measure of a physiological parameter that is above or below a specified value range, an indication of enabling or disabling of a device-based heart failure therapy other than CCM therapy, a detected cardiac arrhythmia, a detected physical activity level that exceeds a specified threshold value, or a detected magnetic resonance imaging.

15. The apparatus of claim 1, wherein the CCM stressor condition includes at least one of:

(1) an indication of enabling or disabling of a device-based heart failure therapy other than CCM therapy, or (2) a detected physical activity level that exceeds a specified threshold value.

16. The apparatus of claim 1, wherein the adverse event detector circuit comprises:

a CCM trigger detector circuit configured to detect a CCM trigger condition for enabling CCM; and

a CCM stressor detector circuit configured to detect a CCM stressor for disabling CCM; and

wherein the controller circuit is configured to enable the CCM therapy when at least one CCM trigger is detected and to disable CCM when at least one CCM stressor is detected.

17. The apparatus of claim 16, wherein the CCM trigger condition includes at least one of:

an indication of worsening heart failure, an indication of worsening kidney function, an indication of worsening hemodynamic status, an indication of a measure of a physiological parameter that is above or below a specified value range, an indication of dyspnea, a detected physical activity level that is below a specified threshold value, or an indication of an enabling or disabling of a device-based heart failure therapy other than CCM therapy.

18. The apparatus of claim 16, wherein the CCM stressor condition includes at least one of:

a detection of sleep disordered breathing, a detected myocardial ischemia, a detected myocardial infarction, an indication of improving heart failure status, an indication of a measure of a physiological parameter that is above or below a specified value range, an indication of enabling or disabling of a device-based heart failure therapy other than CCM therapy, a detected cardiac arrhythmia, a detected physical activity level that exceeds a specified threshold value, or a detected magnetic resonance imaging.

19. The apparatus of claim 16, wherein the CCM trigger condition includes at least one of:

(1) an indication of worsening heart failure, or (2) an indication of an enabling or disabling of a device-based heart failure therapy other than CCM therapy; and

wherein the CCM stressor condition includes at least one of;

(1) an indication of enabling or disabling of a device-based heart failure therapy other than CCM therapy, or (2) a detected physical activity level that exceeds a specified threshold value.

20. An apparatus comprising:

an implantable cardiac rhythm/function management device comprising;

a cardiac contractility modulation (CCM) therapy circuit configured to deliver a CCM therapy including a non-stimulatory electrical energy during a refractory period of the heart;

an adverse event detector circuit including a CCM stressor detector circuit configured to detect a CCM stressor for disabling the CCM therapy, wherein the CCM stressor includes a detected magnetic resonance imaging; and

a controller circuit, coupled to the CCM therapy circuit and the adverse event detector circuit, the controller circuit configured to obtain or provide information about a CCM condition and information about an adverse event, the controller circuit configured to adjust the CCM therapy using the information about the adverse event from the adverse event detector circuit, wherein the controller circuit is configured to disable the CCM therapy when a MRI is detected.