Method and apparatus for controlling cardiac therapy using ultrasound transducer

• US 7,914,452 B2
• Filed: 10/10/2006
• Issued: 03/29/2011
• Est. Priority Date: 10/10/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Pastore, Joseph M., Kramer, Andrew P., Stahmann, Jeffrey E., Hartley, Jesse W., Salo, Rodney W.
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): Heller; Tammie K
• Application Number:
  US11/539,939
• Publication Number:
  US 20080086036A1
• Time in Patent Office: 1,631 Days
• Field of Search: 600/439, 600/450
• US Class Current: 600/439
• 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 1/36528 the parameter being measured by means of ultrasound

Abstract

A cardiac rhythm management (CRM) system provides for post-myocardial infarction (MI) therapy with closed-loop control using one or more ultrasound transducers sensing one or more ultrasound signals indicative of cardiac dimensions. Cardiac size parameters are produced using the one or more ultrasound signals to represent, for example, cardiac chamber diameter, cardiac chamber volume, cardiac wall thickness, infarct size, and degree of change in any of these parameters over time or between measurements. In various embodiments, such cardiac size parameters provide for titration, safety check, and acute optimization of the post-MI therapy.

Claims

1. A system for applying electrical stimulation to a living body having a heart having boundary surfaces and a right atrium (RA), a left atrium (LA), a right ventricle (RV), a left ventricle (LV), and a coronary vein, the system comprising:

one or more implantable ultrasound transducers adapted to sense one or more ultrasound signals indicative of one or more cardiac dimensions, the one or more implantable ultrasound transducers each including a transceiver adapted to transmit a signal and receive a reflected signal being the signal transmitted by the transceiver and reflected from one of the boundary surfaces; and

an implantable medical device comprising;

a stimulation output circuit to deliver the electrical stimulation;

a cardiac size analyzer adapted to receive the one or more ultrasound signals and produce one or more cardiac size parameters using the one or more ultrasound signals, the one or more cardiac size parameters including one or more of;

an infarct size parameter representative of an estimated size of an infarct region;

a parameter indicative of change in the infarct size parameter; and

a parameter indicative of rate of change in the infarct size parameter; and

a stimulation controller coupled to the stimulation output circuit, the stimulation controller including;

a stimulation delivery controller adapted to control the delivery of the electrical stimulation using stimulation parameters; and

a stimulation adjustor adapted to adjust the stimulation parameters using the one or more cardiac size parameters.

2. The system of claim 1, wherein the stimulation output circuit comprises a pacing output circuit to deliver cardiac pacing pulses, and the stimulation controller is adapted to control the delivery of the cardiac pacing pulses.

3. The system of claim 1, wherein the stimulation output circuit comprises a neurostimulation output circuit to deliver neurostimulation, and the stimulation controller is adapted to control the delivery of the neurostimulation.

4. The system of claim 1, wherein the stimulation output circuit comprises a defibrillation output circuit to deliver cardioversion/defibrillation pulses, and the stimulation controller is adapted to control the delivery of the cardioversion/defibrillation pulses.

5. The system of claim 1, wherein the implantable medical device comprises one or more of a cardiac sensing circuit to sense a cardiac signal, a heart sound sensing circuit to sense a heart sound signal, and an impedance sensing circuit to sense an intracardiac impedance signal;

the cardiac size analyzer comprises an event detector adapted to detect one or more predetermined type cardiac events from one or more of the cardiac signal, the heart sound signal, and the intracardiac impedance signal; and

the cardiac size analyzer is adapted to produce the one or more cardiac size parameters by sampling the one or more ultrasound signals in response to the detection of the one or more predetermined type cardiac events.

6. The system of claim 5, wherein the cardiac size analyzer is adapted to produce a cardiac wall thickness parameter representative of a cardiac wall thickness in a cardiac region.

7. The system of claim 6, wherein the cardiac size analyzer is adapted to produce a parameter indicative of change in the cardiac wall thickness parameter.

8. The system of claim 6, wherein the cardiac size analyzer is adapted to produce a parameter indicative of rate of change in the cardiac wall thickness parameter.

9. The system of claim 1, wherein the stimulation adjuster comprises a feedback controller adapted to adjust the stimulation parameters to maintain an effect of the electrical stimulation within a target region defined by at least one or more values of the one or more cardiac size parameters.

10. The system of claim 9, wherein the feedback controller is adapted to adjust the stimulation parameters to maintain the effect of the electrical stimulation within a target region defined by one or more values of the one or more cardiac size parameters and one or more values of one or more hemodynamic parameters, wherein the implantable medical device comprises a hemodynamic performance analyzer adapted to produce the one or more hemodynamic parameters using one or more physiologic signals, and further comprising one or more implantable physiologic sensors coupled to the hemodynamic performance analyzer and adapted to sense the one or more physiologic signals.

11. The system of claim 1, wherein the stimulation adjustor comprises a safety switch adapted to initiate, terminate, or adjust the delivery of the electrical stimulation in response to an alert signal indicative of a detection of a specified type cardiac condition.

12. The system of claim 11, wherein the cardiac size analyzer comprises:

a cardiac remodeling detector adapted to detect a degree of cardiac remodeling using the one or more cardiac size parameters and produce a remodeling parameter representative of the detected degree of cardiac remodeling; and

an alert signal generator adapted to generate a remodeling alert signal when the remodeling parameter exceeds a predetermined threshold,

and wherein the safety switch is adapted to initiate, terminate, or adjust the delivery of the electrical stimulation in response to the remodeling alert signal.

13. The system of claim 11, wherein the cardiac size analyzer comprises

an alert signal generator adapted to generate an infarction alert signal when the one or more cardiac size parameters exceeds a predetermined threshold,

and wherein the safety switch is adapted to initiate, terminate, or adjust the delivery of the electrical stimulation in response to the infarction alert signal.

14. The system of claim 1, wherein the stimulation adjustor comprises a stimulation parameter selector adapted to receive values of the one or more cardiac size parameters associated with multiple sets of stimulation parameters and select an optimal set of stimulation parameters from the multiple sets of stimulation parameters based on the values of the one or more cardiac size parameters.

15. The system of claim 1, wherein the cardiac size analyzer is adapted to produce one or more of:

a cardiac chamber diameter parameter representative of a single plane cardiac chamber diameter;

a parameter indicative of change in the cardiac chamber diameter parameter;

a parameter indicative of rate of change in the cardiac chamber diameter parameter;

a cardiac chamber volume parameter representative of an estimated cardiac chamber volume;

a parameter indicative of change in the cardiac chamber volume parameter; and

a parameter indicative of rate of change in the cardiac chamber volume parameter.

16. The system of claim 15, wherein the cardiac size analyzer is adapted to produce one or more of:

a parameter indicative of ejection fraction, using at least one of the cardiac chamber diameter parameter and the cardiac chamber volume parameter;

a parameter indicative of change in the ejection fraction, using at least one of the parameter indicative of change in the cardiac chamber diameter parameter and the parameter indicative of change in the cardiac chamber volume parameter; and

a parameter indicative of rate of change in the ejection fraction, using at least one of the parameter indicative of rate of change in the cardiac chamber diameter parameter and the parameter indicative of rate of change in the cardiac chamber volume parameter.

17. The system of claim 1, further comprising an implantable lead including:

a proximal end configured to be coupled to the implantable medical device;

a distal portion configured to be placed in or about the heart, the distal portion including the one or more implantable ultrasound transducers; and

an elongate body coupled between the proximal end and the distal portion.

18. The lead of claim 17, wherein the one or more implantable ultrasound transducers comprise at least one rotating ultrasound transducer configured to sense a plurality of distances in a plane and having a mechanically controlled directionality.

19. The lead of claim 18, wherein the distal portion comprises a motor coupled to the at least one rotating ultrasound transducer.

20. The lead of claim 19, wherein the distal portion comprises a plurality of rotating ultrasound transducers.

21. The lead of claim 17, wherein the one or more implantable ultrasound transducers comprise one or more phased array ultrasound transducers each including a plurality of transducer elements and having an electronically controlled directionality.

22. The lead of claim 17, wherein the distal portion is configured to be placed in the RA, and the one or more ultrasound transducers are adapted to sense one or more ultrasound signals indicative of one or more atrial dimensions.

23. The lead of claim 17, wherein the distal portion is configured to be placed in the RV, and the one or more ultrasound transducers are adapted to sense one or more ultrasound signals indicative of one or more ventricular dimensions.

24. The lead of claim 17, wherein the distal portion is configured to be placed in the coronary vein over the LV, and the one or more ultrasound transducers are adapted to sense one or more ultrasound signals indicative of one or more ventricular dimensions.

25. The system of claim 1, wherein the cardiac size analyzer is adapted to produce one or more of:

a cardiac wall thickness parameter representative of a cardiac wall thickness in a cardiac region;

a parameter indicative of change in the cardiac wall thickness parameter; and

a parameter indicative of rate of change in the cardiac wall thickness parameter.

26. A system for applying electrical stimulation to a living body having a heart having boundary surfaces and an infarct region, the system comprising:

one or more implantable ultrasound transducers adapted to sense one or more ultrasound signals indicative of one or more cardiac dimensions, the one or more implantable ultrasound transducers each including a transceiver adapted to transmit a signal and receive a reflected signal being the signal transmitted by the transceiver and reflected from one of the boundary surfaces; and

an implantable medical device comprising;

a stimulation output circuit to deliver the electrical stimulation;

one or more of a cardiac sensing circuit to sense a cardiac signal, a heart sound sensing circuit to sense a heart sound signal, and an impedance sensing circuit to sense an intracardiac impedance signal;

a cardiac size analyzer including an event detector adapted to detect one or more predetermined type cardiac events from one or more of the cardiac signal, the heart sound signal, and the intracardiac impedance signal, the cardiac size analyzer adapted to receive the one or more ultrasound signals and produce one or more cardiac size parameters including an infarct size parameter representative of an estimated size of the infarct region by sampling the one or more ultrasound signals in response to the detection of the one or more predetermined type cardiac events; and

a stimulation controller coupled to the stimulation output circuit, the stimulation controller including;

a stimulation delivery controller adapted to control the delivery of the electrical stimulation using stimulation parameters; and

a stimulation adjustor adapted to adjust the stimulation parameters using the one or more cardiac size parameters.

27. The system of claim 26, wherein the cardiac size analyzer is adapted to produce a parameter indicative of change in the infarct size parameter.

28. The system of claim 26, wherein the cardiac size analyzer is adapted to produce a parameter indicative of rate of change in the infarct size parameter.

29. The system of claim 26, wherein the stimulation adjuster comprises a feedback controller adapted to adjust the stimulation parameters to maintain an effect of the electrical stimulation within a target region defined by at least one or more values of the one or more cardiac size parameters.

30. The system of claim 29, wherein the feedback controller is adapted to adjust the stimulation parameters to maintain the effect of the electrical stimulation within a target region defined by one or more values of the one or more cardiac size parameters and one or more values of one or more hemodynamic parameters, wherein the implantable medical device comprises a hemodynamic performance analyzer adapted to produce the one or more hemodynamic parameters using one or more physiologic signals, and further comprising one or more implantable physiologic sensors coupled to the hemodynamic performance analyzer and adapted to sense the one or more physiologic signals.

31. The system of claim 29, wherein the stimulation output circuit comprises a pacing output circuit to deliver cardiac pacing pulses, and the stimulation controller is adapted to control the delivery of the cardiac pacing pulses.

32. The system of claim 29, wherein the stimulation output circuit comprises a neurostimulation output circuit to deliver neurostimulation, and the stimulation controller is adapted to control the delivery of the neurostimulation.