Method and apparatus for control of cardiac therapy using non-invasive hemodynamic sensor

• US 20070150014A1
• Filed: 12/22/2005
• Published: 06/28/2007
• Est. Priority Date: 12/22/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Pastore, Joseph, Salo, Rodney, Hartley, Jesse, Kramer, Andrew, Stahmann, Jeffrey
• Granted Patent: US 8,046,069 B2
• Time in Patent Office: Days
• US Class Current: 607/17
• CPC Class Codes: A61B 5/6816 Ear lobe
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6829 Foot or ankle
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood
• CPC Class Codes: A61N 1/36564 controlled by blood pressure

Abstract

A cardiac rhythm management (CRM) system includes a non-invasive hemodynamic sensing device and an implantable medical device to sense a hemodynamic signal and derive one or more cardiac performance parameters from the hemodynamic signal. The non-invasive hemodynamic sensing device includes at least a portion configured for external attachment to a body in which the implantable medical device is implanted. The one or more cardiac performance parameters are used for various diagnostic, monitoring, and therapy control purposes.

Claims

1. A system coupled to a body having external appendages, the system comprising:

a non-invasive hemodynamic sensing device including at least a portion configured to be attached to one of the external appendages, the non-invasive hemodynamic sensing device including;

a hemodynamic sensor to sense a hemodynamic signal;

a sensor signal processor to produce hemodynamic data associated with the hemodynamic signal; and

a sensor telemetry circuit to transmit the hemodynamic data from the non-invasive hemodynamic sensing device; and

an implantable medical device communicatively coupled to the non-invasive hemodynamic sensing device, the implantable medical device including;

an implant telemetry circuit to receive the hemodynamic data from the non-invasive hemodynamic sensing device;

an electrical stimulation circuit to deliver electrical stimulation; and

a stimulation controller adapted to control the delivery of the electrical stimulation using one or more stimulation parameters, the stimulation controller including a stimulation parameter adjustment module adapted to adjust the one or more stimulation parameters using the hemodynamic data.

2. The system of claim 1, wherein the hemodynamic sensor is adapted to sense one or more of a signal indicative of arterial blood volume, a signal indicative of pulse pressure, a signal indicative of blood oxygen saturation, and a signal indicative of heart rate.

3. The system of claim 2, wherein the hemodynamic sensor comprises one of a finger clip sensor, a toe clip sensor, and an ear clip sensor.

4. The system of claim 2, wherein the hemodynamic sensor comprises a plethysmography sensor.

5. The system of claim 2, wherein the hemodynamic sensor comprises a pulse oximeter.

6. The system of claim 1, wherein the hemodynamic sensor comprises a pressure sensor adapted to sense a peripheral blood pressure.

7. The system of claim 1, wherein the non-invasive hemodynamic sensing device comprises a portable repeater coupled to the hemodynamic sensor, the portable repeater including at least portions of the signal processor and the sensor telemetry circuit.

8. The system of claim 7, comprising a finger clip device and a wrist band, wherein the hemodynamic sensor is incorporated into the finger clip device, and the portable repeater is incorporated into the wrist band.

9. The system of claim 1, wherein the implantable medical device comprises an implant signal processor adapted to process the hemodynamic data, and wherein one of the sensor signal processor and the implant signal processor comprises a parameter generator adapted to produce one or more cardiac performance parameters using the hemodynamic data.

10. The system of claim 9, wherein the parameter generator comprises one or more of:

a pulse pressure generator adapted to produce a pulse pressure parameter representative of pulse pressure;

a blood oxygen saturation generator adapted to produce a blood oxygen saturation parameter representative of blood oxygen saturation; and

a heart rate generator to produce a heart rate parameter representative of heart rate.

11. The system of claim 9, wherein the stimulation-parameter adjustment module is adapted to adjust the one or more stimulation parameters using the one or more cardiac performance parameters.

12. The system of claim 11, wherein the stimulation parameter adjustment module comprises a stimulation parameter optimization module adapted to approximately optimize at least one stimulation parameter of the one or more stimulation parameters using the one or more cardiac performance parameters.

13. The system of claim 9, wherein the implant telemetry circuit is further adapted to transmit data from the implantable medical device, and the implantable medical device comprises a data storage device adapted to store data representative of the one or more cardiac performance parameters, and further comprising an external system communicatively coupled to the implantable medical device, the external system including:

an external telemetry circuit to receive data from the implantable medical device;

a user input device adapted to receive user commands including a data retrieval command for retrieving data stored in the data storage device of the implantable medical device; and

a presentation device to present the retrieved data including at least one of data representative of the hemodynamic signal and data representative of the one or more cardiac performance parameters.

14. The system of claim 9, wherein the electrical stimulation circuit comprises a pacing circuit to deliver pacing pulses, the stimulation controller comprises a pacing controller to control the delivery of the pacing pulses using one or more pacing parameters, and the stimulation parameter adjustment module comprises a pacing parameter adjustment module adapted to adjust the one or more pacing parameters using the one or more cardiac performance parameters.

15. The system of claim 14, wherein the pacing parameter adjustment module is adapted to adjust the one or more pacing parameters to approximately maximize ventricular unloading while the one or more cardiac performance parameters indicate a tolerable level of cardiac output.

16. The system of claim 14, wherein the pacing parameter adjustment module comprises a pacing safety switch adapted to start, stop, or adjust the delivery of the pacing pulses using the one or more cardiac performance parameters.

17. The system of claim 9, wherein the electrical stimulation circuit comprises a neural stimulation circuit to deliver neural stimulation pulses, the stimulation controller comprises a neural stimulation controller to control the delivery of the neural stimulation pulses using one or more neural stimulation parameters, and the stimulation parameter adjustment module comprises a neural stimulation parameter adjustment module adapted to adjust the one or more neural stimulation parameters using the one or more cardiac performance parameters.

18. The system of claim 17, wherein the neural stimulation parameter adjustment module is adapted to adjust the one or more neural stimulation parameters for preventing ventricular remodeling while the one or more cardiac performance parameters indicate one or more of a tolerable level of pulse pressure and a tolerable heart rate.

19. The system of claim 17, wherein the neural stimulation parameter adjustment module is adapted to adjust the one or more neural stimulation parameters for lowering blood pressure when the one or more cardiac performance parameters indicate an abnormally high blood pressure.

20. The system of claim 17, wherein the neural stimulation parameter adjustment module comprises a neural stimulation safety switch adapted to start, stop, or adjust the delivery of the neural stimulation pulses using the one or more cardiac performance parameters.

21. The system of claim 9, wherein the electrical stimulation circuit comprises a cardiac electrical stimulation circuit to deliver cardiac stimulation pulses including one or more of pacing pulses and cardioversion/defibrillation pulses, and the stimulation controller comprises an arrhythmia detector adapted to detect and classify arrhythmias using at least the one or more cardiac performance parameters, the stimulation controller adapted to control the delivery of the cardiac stimulation pulses to treat the detected arrhythmias according to the classification of each of the detected arrhythmias.

22. A method for delivering electrical stimulation to a body having external appendages, the method comprising:

sensing a hemodynamic signal using a non-invasive hemodynamic sensor attached to one of the external appendages of the body;

producing hemodynamic data associated with the hemodynamic signal;

transmitting the hemodynamic data to an implantable medical device through a wireless communication link;

adjusting one or more stimulation parameters using the hemodynamic data using a stimulation controller of the implantable medical device;

controlling the delivery of the electrical stimulation using the one or more stimulation parameters; and

delivering the electrical stimulation from the implantable medical device.

23. The method of claim 22, wherein sensing the hemodynamic signal comprises sensing a hemodynamic signal indicative of one or more of arterial-blood volume, pulse pressure, blood oxygen saturation, and heart rate.

24. The method of claim 23, wherein sensing the hemodynamic signal comprises sensing one or more of a plethysmogram, an oximetry signal, and a blood pressure signal.

25. The method of claim 22, further comprising producing one or more cardiac performance parameters using the hemodynamic signal, the one or more cardiac performance parameters each being a measure of cardiac function.

26. The method of claim 25, wherein producing the one or more cardiac performance parameters comprises producing one or more of a pulse pressure parameter representative of pulse pressure, a blood oxygen saturation parameter representative of blood oxygen saturation, and a heart rate parameter representative of a heart rate.

27. The method of claim 25, wherein producing the one or more cardiac performance parameters comprises producing the one or more cardiac performance parameters using a signal processor external to the implantable medical device, and transmitting the hemodynamic data to the implantable medical device comprises transmitting the one or more cardiac performance parameters to the implantable medical device.

28. The method of claim 25, wherein producing the one or more cardiac performance parameters comprises producing the one or more cardiac performance parameters using a signal processor of the implantable medical device, and transmitting the hemodynamic data to the implantable medical device-comprises transmitting data representative of the hemodynamic signal to the implantable medical device.

29. The method of claim 25, wherein controlling the delivery of the electrical stimulation comprises adjusting the one or more stimulation parameters using the one or more cardiac performance parameters.

30. The method of claim 29, wherein adjusting the one or more stimulation parameters comprises approximately optimizing at least one stimulation parameter of the one or more stimulation parameters using the one or more cardiac performance parameters.

31. The method of claim 25, further comprising:

storing one or more of data representative of the hemodynamic signal and data representative of the one or more cardiac performance parameters in the implantable medical device;

receiving user commands including a data retrieval command;

retrieving data including the stored one or more of the data representative of the hemodynamic signal and the data representative of the one or more cardiac performance parameters;

transmitting the retrieved data from the implantable medical device to an external system via telemetry; and

presenting one or more of the hemodynamic signal and the one or more cardiac performance parameters using a presentation device of the external system.

32. The method of claim 25, wherein delivering the electrical stimulation comprises delivering cardiac pacing pulses, and controlling the delivery of the electrical stimulation using the hemodynamic signal comprises:

controlling the delivery of the cardiac pacing pulses using one or more pacing parameters; and

adjusting the one or more pacing parameters using the one or more cardiac performance parameters.

33. The method of claim 32, wherein the one or more cardiac performance parameters comprises a pulse pressure parameter representative of pulse pressure, and adjusting the one or more pacing parameters comprises:

comparing the pulse pressure parameter to a predetermined threshold pulse pressure; and

adjusting the one or more pacing parameters to approximately maximize ventricular unloading while the pulse pressure parameter is above the predetermined threshold pulse pressure.

34. The method of claim 32, wherein the one or more cardiac performance parameters comprises a pulse pressure parameter representative of pulse pressure, and adjusting the one or more pacing parameters comprises:

comparing the pulse pressure parameter to a predetermined threshold pulse pressure; and

stopping the delivery of the pacing pulses when the pulse pressure parameter drops below a first predetermined threshold pulse pressure and starting the delivery of the pacing pulses when the pulse pressure parameter rises above a second predetermined threshold pulse pressure, the first predetermined threshold pulse pressure lower than the second predetermined threshold pulse pressure.

35. The method of claim 25, wherein delivering the electrical stimulation comprises delivering neural stimulation pulses, and controlling the delivery of the electrical stimulation using the hemodynamic signal comprises:

controlling the delivery of the neural stimulation pulses using one or more neural stimulation parameters; and

adjusting the one or more neural stimulation parameters using the one or more cardiac performance parameters.

36. The method of claim 35, wherein the one or more cardiac performance parameters comprises at least one of a pulse pressure parameter representative of pulse pressure and a heart rate parameter representative of heart rate, and adjusting the one or more pacing parameters comprises:

comparing each of the one or more cardiac performance parameters to a corresponding predetermined threshold indicative of a tolerable level of hemodynamic performance; and

adjusting the one or more pacing parameters to approximately maximize ventricular unloading using at least one outcome of the comparison.

37. The method of claim 35, wherein the one or more cardiac performance parameters comprises a pulse pressure parameter representative of pulse pressure, and adjusting the one or more pacing parameters comprises:

comparing each of the one or more cardiac performance parameters to a corresponding predetermined threshold indicative of a tolerable level of hemodynamic performance; and

starting stopping, or adjusting the delivery of the neural stimulation pulses using at least one outcome of the comparison.

38. The method of claim 25, wherein delivering the electrical stimulation comprises delivering cardiac electrical stimulation pulses including at least one of cardiac pacing pulses and cardioversion/defibrillation pulses, and controlling the delivery of the electrical stimulation using the hemodynamic signal comprises:

controlling the delivery of the cardiac stimulation pulses using one or more cardiac stimulation parameters;

detecting and classifying arrhythmias using the one or more cardiac performance parameters; and

adjusting the one or more cardiac stimulation parameters to treat each of the detected arrhythmia according to the classification of that arrhythmia in response to the detection of that arrhythmia.

39. The method of claim 22, wherein controlling the delivery of the electrical stimulation comprises switching between therapy modes.

40. The method of claim 39, wherein controlling the delivery of the electrical stimulation comprises switching between two or more of a bradycardia pacing mode, a cardiac resynchronization therapy mode, a cardiac remodeling control therapy mode, a cardioversion mode, a defibrillation mode, and a neural stimulation mode.