Remote closed-loop titration of decongestive therapy for the treatment of advanced heart failure

• US 8,972,002 B2
• Filed: 02/28/2013
• Issued: 03/03/2015
• Est. Priority Date: 06/01/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Wariar, Ramesh, Maskara, Barun, An, Qi, Thakur, Pramodsingh Hirasingh, Thompson, Julie A.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US13/781,258
• Publication Number:
  US 20130178786A1
• Time in Patent Office: 733 Days
• Field of Search: 607/3, 128/200.24
• US Class Current: 604/20
• CPC Class Codes: A61B 7/00 Instruments for auscultation
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/42 Rate
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• 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 1/36564 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 1/36592 controlled by the heart rate variability
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

An apparatus comprises one or more physiological sensing circuits that generate a sensed physiological signal and at least one of the physiological sensing circuits is implantable, a measurement circuit configured to recurrently measure one or more physiological parameters that indicate a status of heart failure of the subject, a comparison circuit configured to compare the one or more physiological parameter measurements to one or more physiological parameter target values, a therapy circuit configured to control delivery of one or more drugs to treat heart failure, and a control circuit in electrical communication with the comparison circuit and the therapy circuit and configured to recurrently adjust delivery of drug therapy according to the comparison of the measured physiological parameters to the physiological parameter targets.

Claims

1. An apparatus comprising:

one or more physiological sensing circuits including an implantable sensing circuit and an external sensing circuit, wherein the implantable physiological sensing circuit is configured to provide a first sensed physiological signal and the external sensing circuit is configured to provide a second sensed physiological signal, wherein the second sensed physiological signal is representative of at least one of;

weight of the subject, respiration of the subject, a heart sound of the subject, arterial blood pressure of the subject, an indication of peripheral edema of the subject, thoracic fluid present in the subject, or a level of biochemical analyte present in the subject;

a measurement circuit configured to recurrently measure one or more physiological parameters of a subject that indicate a status of heart failure of the subject, including a first physiological parameter using the first sensed physiological signal and a second physiological parameter using the second sensed physiological signal, wherein the second physiological parameter includes at least one of a measured weight of the subject, a respiration parameter of the subject, a magnitude of a heart sound, a time interval between a first heart sound signal feature and a second heart sound signal feature, a measured arterial blood pressure of the subject, a measure of edema of the subject, or an indication of a level of biochemical analyte present in the subject;

a comparison circuit configured to compare the first physiological parameter to a target first physiological parameter value and the second physiological parameter to a target second physiological parameter value and provide an indication of an outcome of a comparison;

a therapy circuit configured to control delivery of one or more drugs to treat heart failure; and

a control circuit in electrical communication with the comparison circuit and the therapy circuit and configured to adjust delivery of the drug therapy according to the outcome of the comparison of the first and second physiological parameters to the target first and second physiological parameter values.

2. The apparatus of claim 1,

wherein the one or more physiological sensing circuits includes a heart sound sensing circuit configured to generate a sensed heart sound signal, wherein the heart sound signal is representative of mechanical activity of the heart of the subject,

wherein the measurement circuit is configured to measure at least one of a magnitude of a heart sound or a time interval between a first heart sound signal feature and a second heart sound signal feature, and

wherein the control circuit is configured to adjust delivery of the drug therapy according to a comparison of the least one of the measured magnitude or the measured time interval to at least one of a target heart sound magnitude value or a time interval target value.

3. The apparatus of claim 1, wherein the therapy circuit is configured to control titration of an inotropic agent to the subject.

4. The apparatus of claim 1, wherein the therapy circuit is configured to control titration of at least one of a diuretic agent, an aquaretic agent, or a vasodilating agent to the subject according to the comparison.

5. The apparatus of claim 1, wherein the therapy circuit is configured to control delivery of at least one of a crystalloid or a colloid to the subject according to the comparison.

6. The apparatus of claim 1,

wherein the one or more physiological sensing circuits includes an implantable pressure sensing circuit configured to generate a sensed pressure signal, wherein the pressure signal is representative of at least one of arterial blood pressure, central, venous pressure, pulmonary artery pressure, left atrial pressure, or abdominal pressure of the subject,

wherein the measurement circuit is configured to provide a measure of at least one of arterial blood pressure, central venous pressure, pulmonary artery pressure, left atrial pressure, or abdominal pressure using the sensed pressure signal, and

wherein the comparison circuit is configured to provide an indication of an outcome of at least one of:

a comparison of a measure of arterial blood pressure to a target arterial blood pressure, a comparison of a measure of central venous pressure to a target central venous pressure value, a comparison of a measure of pulmonary artery pressure to a target pulmonary artery pressure, a comparison of a measure of left atrial pressure to a target left atrial pressure value, or a comparison of a measure of abdominal pressure to a target value of abdominal pressure, and wherein the control circuit is configured to recurrently adjust delivery of the drug therapy according to the at least one comparison.

7. The apparatus of claim 1,

wherein the one or more physiological sensing circuits includes an implantable cardiac activity sensing circuit configured to generate a cardiac activity signal and an implantable physical activity sensing circuit configured to generate a physical activity signal representative of physical activity of the subject,

wherein the measurement circuit is configured to provide a measure of at least one of a heart rate of the subject or a physiological response to activity of the subject, and

wherein the comparison circuit is configured to provide an indication of an outcome of at least one of:

a comparison of the heart rate of the subject to a target heart rate value, or a comparison of the measure of physiologic response to activity to a physiological response target.

8. The apparatus of claim 1,

wherein the one or more physiological sensing circuits includes at least one of an implantable respiration sensing circuit configured to generate a respiration signal representative of respiration of the subject, or an implantable impedance circuit configured to generate at least one of an impedance signal representative of intra-thoracic impedance of the subject or an impedance signal representative of intracardiac impedance of the subject,

wherein the measurement circuit is configured to provide at least one of:

a measure of a respiration parameter, a measure of intra-thoracic impedance, or a measure of intracardiac impedance, and

wherein the comparison circuit is configured to provide an indication of an outcome of at least one of;

a comparison of the measured respiration parameter to a respiration parameter target value, a comparison of the measure of intra-thoracic impedance to a target intra-thoracic impedance value, or a comparison of the measure of intracardiac impedance to a target intracardiac impedance value.

9. The apparatus of claim 1, including an external device and an implantable device, wherein the comparison circuit, the therapy circuit and the control circuit are included in the external device, and the implantable device is configured to communicate the measure of the one or more physiological parameters to the external device.

10. The apparatus of claim 9, wherein the implantable device includes a second therapy circuit configured to provide electrical cardiac therapy to the heart of the subject, wherein the control circuit is configured to initiate delivery of electrical cardiac therapy according to the comparison of the measured physiological parameters to the physiological parameter targets.

11. The apparatus of claim 1, wherein the measurement circuit, the comparison circuit, the therapy circuit, the control circuit and the at least one implantable physiological sensor are included in an implantable device.

12. The apparatus of claim 1,

wherein the one or more physiological sensing circuits includes a heart sound sensing circuit configured to generate a sensed heart sound signal and a cardiac electrogram sensing circuit configured to generate a sensed cardiac electrogram signal, wherein the electrogram signal is representative of electrical activity of the heart of the subject,

wherein the measurement circuit is configured to measure a time interval between a feature of the electrogram signal and a feature of the heart sound signal, and

wherein the control circuit is configured to adjust delivery of the drug therapy according to a comparison of the measured time interval to a time interval target value.

13. A method comprising:

generating at least a first sensed physiological signal using an implantable physiological sensing circuit and at least a second sensed physiological signal using an external sensing circuit, wherein the external sensing circuit provides a physiological signal representative of at least one of a weight of the subject, arterial blood pressure of the subject, a measure of peripheral edema of the subject, or a level of biochemical analyte present in the subject;

measuring at least a first physiological parameter indicative of a status of heart failure of the subject using the first sensed physiological signal and at least a second physiological parameter using the second sensed physiological signal, wherein the second physiological parameter includes at least one of a measured weight of the subject, a measured arterial blood pressure of the subject, a measure of peripheral edema of the subject, or a measure of a level of biochemical analyte present in the subject;

comparing the first physiological parameter to a target first physiological parameter value and comparing the second physiological parameter to a target second physiological parameter value using a device that provides a drug therapy to treat heart failure; and

recurrently adjusting a drug therapy according to the comparison of the first and second physiological parameters to the target first and second physiological parameter values.

14. The method of claim 13,

wherein generating at least a first and second sensed physiological signals includes generating a heart sound signal using an implantable heart sound sensing circuit, wherein the heart sound signal is representative of mechanical activity of the heart of the subject, and

wherein measuring at least a first and second physiological parameters includes measuring at least one of:

a magnitude of a heart sound and adjusting drug therapy includes adjusting the drug therapy according to a comparison of the parameter to a target heart sound magnitude value;

or

a time interval between a first heart sound signal feature and a second heart sound signal feature and adjusting drug therapy includes adjusting the drug therapy according to a comparison of the parameter to a time interval target value.

15. The method of claim 13, wherein recurrently adjusting drug therapy includes adjusting device-based titration of an inotropic agent to the subject according to the comparison, and wherein the method further includes recurrently adjusting device-based electrical cardiac therapy according to the comparison of the measured physiological parameters to the physiological parameter targets.

16. The method of claim 13,

wherein generating at least a first and second sensed physiological signals includes generating a pressure signal generated using an implantable pressure sensing circuit, wherein the pressure signal is representative of at least one of arterial blood pressure, central venous pressure, pulmonary artery pressure, left atrial pressure, or abdominal pressure of the subject, and

wherein comparing the measured physiological parameters to one or more physiological parameter targets includes at least one of comparing a measure of arterial blood pressure to a target arterial blood pressure, comparing a measure of central venous pressure to a target central venous pressure value, comparing a measure of pulmonary artery pressure to a target pulmonary artery pressure, comparing a measure of left atrial pressure to a target left atrial pressure value, or comparing a measure of abdominal pressure to a target value of abdominal pressure.

17. The method of claim 13,

wherein generating at least a first and second sensed physiological signals includes at least one of:

generating a cardiac activity signal using an implantable cardiac signal sensing circuit or generating a physical activity signal representative of physical activity of the subject using an implantable physical activity sensing circuit,

wherein measuring at least a first and second physiological parameters includes measuring at least one of heart rate of the subject or physiological response to activity of the subject, and

wherein comparing the measured physiological parameters to physiological parameter targets includes comparing the heart rate of the subject to a target heart rate value or comparing the physiologic response of the subject to activity to a physiological response target.

18. An apparatus comprising:

one or more physiological sensing circuits configured to generate a sensed physiological signal that includes physiological information, and wherein at least one of the physiological sensing circuits includes an implantable sensing circuit configured to generate a physiological signal indicative of a level of a biochemical analyte present in the subject,

a measurement circuit configured to recurrently measure one or more physiological parameters of a subject using one or more of the sensed physiological signals including the level of biochemical analyte, wherein the one or more physiological parameters indicate a status of heart failure of the subject;

a comparison circuit configured to compare the one or more physiological parameter measurements to one or more physiological parameter target values and provide an indication of an outcome of a comparison of the indicated level of biochemical analyte to a target level of the biochemical analyte;

a therapy circuit configured to control delivery of one or more drugs to treat heart failure; and

a control circuit in electrical communication with the comparison circuit and the therapy circuit and configured to recurrently adjust delivery of drug therapy according to the comparison of the measured physiological parameters to the physiological parameter targets.