Non-invasive cardiac monitoring system and method with communications interface

• US 6,162,180 A
• Filed: 12/28/1998
• Issued: 12/19/2000
• Est. Priority Date: 12/28/1998
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Miesel, Keith A., Stylos, Lee
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): ASTORINO, MICHAEL C
• Application Number:
  US09/221,038
• Time in Patent Office: 722 Days
• Field of Search: 600/481-486, 600/500-504, 600/529-534, 600/538-539
• US Class Current: 600/481
• CPC Class Codes: A61B 5/083 Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
• CPC Class Codes: A61N 1/36557 controlled by chemical substances in blood

Abstract

A system and method for determining a patient'"'"'s cardiac output in a non-invasive manner and transmitting cardiac output data to a remote host processor, a communications system, or a local output device is disclosed. A non-invasive cardiac monitoring approach utilizes an implantable medical device coupled to an oxygen sensor. The oxygen sensor provides venous oxygen saturation data to the implantable medical device. An oxygen consumption unit produces oxygen consumption data using air exhaled by a patient. A processing unit calculates a cardiac output result in real-time using the venous oxygen saturation data, the oxygen consumption data, and arterial oxygen saturation data assumed to be about 100% or acquired using a sensor external to the patient. The implantable medical device may transmit the venous oxygen saturation data to the processing unit using electromagnetic signals or acoustic signals. The implantable medical device may be a pacemaker, a pacemaker/cardioverter/defibrillator (PCD), an oxygen sensing device, or an implantable hemodynamic monitor. The processing unit may store the cardiac output data/result for a period of time and/or communicate the cardiac output result to the remote host processor substantially in real-time via a communications interface. The interface may include a modem, a computer interface, a network interface, or a communications system interface, for example. The processing unit may communicate the cardiac output result to the remote host processor in an analog, digital or optical form.

Claims

1. A non-invasive cardiac monitoring apparatus, comprising:

an implantable medical device coupled to an oxygen sensor, the oxygen sensor providing venous oxygen saturation data to the implantable medical device;

an oxygen consumption unit, the oxygen consumption unit producing oxygen consumption data using air exhaled by a patient; and

a processing unit that receives the venous oxygen saturation data from the implantable medical device and the oxygen consumption data from the oxygen consumption unit, the processing unit calculating a cardiac output result using the venous oxygen saturation data, the oxygen consumption data, and arterial oxygen saturation data, the cardiac output result provided at an output of the processing unit.

2. The apparatus of claim 1, wherein the arterial oxygen saturation data is assumed to be about 100% or is acquired using a sensor external to the patient.

3. The apparatus of claim 2, wherein the sensor comprises a pulse oximeter.

4. The apparatus of claim 1, wherein the processing unit receives the venous oxygen saturation data from the implantable medical device and the oxygen consumption data from the oxygen consumption unit substantially simultaneously.

5. The apparatus of claim 1, wherein the processing unit calculates the cardiac output result substantially in real-time.

6. The apparatus of claim 1, wherein the oxygen consumption unit comprises a mask, securable about the patient'"'"'s nose and mouth, and a sensor assembly, the sensor assembly measuring one or more oxygen consumption parameters.

7. The apparatus of claim 6, wherein the sensor assembly comprises an oxygen consumption sensor.

8. The apparatus of claim 1, wherein the oxygen consumption unit comprises a mask, securable about the patient'"'"'s nose and mouth, a flow sensor, and an oxygen sensor for measuring oxygen content of ambient air, the mask directing the exhaled air through the flow sensor.

9. The apparatus of claim 8, wherein the processing unit computes an oxygen consumption value using oxygen content of ambient air and flow rate data corresponding to a flow rate of the exhaled air measured by the flow sensor.

10. The apparatus of claim 1, wherein the processing unit computes the cardiac output result using Fick'"'"'s principle.

11. The apparatus of claim 1, wherein the cardiac output result, CO, computed by the processing unit is characterized by:

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12. The apparatus of claim 1, further comprising:

an implantable pressure sensor coupled to the implantable medical device; and

an air pressure sensor external to the patient and coupled to the processing unit, the processing unit receiving blood and ambient air pressure data from the implantable pressure sensor and air pressure sensor, respectively, and calculating hemodynamic data using the venous oxygen saturation data, oxygen consumption data, arterial oxygen saturation data, and the blood and ambient air pressure data.

13. The apparatus of claim 1, wherein the implantable medical device comprises one of a pacemaker, a pacemaker/cardioverter/defibrillator (PCD), an oxygen sensing device, or an implantable hemodynamic monitor.

14. The apparatus of claim 1, wherein the implantable medical device transmits the venous oxygen saturation data to the processing unit using electromagnetic signals or acoustic signals.

15. A non-invasive cardiac monitoring apparatus, comprising:

an implantable medical device coupled to an oxygen sensor, the oxygen sensor providing venous oxygen saturation data to the implantable medical device;

an oxygen consumption unit, the oxygen consumption unit producing oxygen consumption data using air exhaled by a patient;

a processing unit that calculates a cardiac output result using the venous oxygen saturation data, the oxygen consumption data, and arterial oxygen saturation data assumed to be about 100% or acquired using a sensor external to the patient; and

an interface, the processing unit communicating the cardiac output result to a remote host processor or to a local output device via the interface.

16. The apparatus of claim 15, wherein the interface comprises a modem, a computer interface, a network interface, or a communications system interface.

17. The apparatus of claim 15, wherein the local output device comprises a display, a charting device, or a printing device.

18. The apparatus of claim 15, wherein the processing unit receives the venous oxygen saturation data from the implantable medical device and the oxygen consumption data from the oxygen consumption unit substantially simultaneously, and the processing unit calculates the cardiac output result substantially in real-time.

19. The apparatus of claim 18, wherein the processing unit stores the cardiac output result or communicates the cardiac output result to the remote host processor substantially in real-time.

20. The apparatus of claim 15, wherein either the processing unit or the remote host processor initiates communication of the cardiac output result to the remote host processor or to the local output device.

21. The apparatus of claim 15, wherein the processing unit communicates the cardiac output result to the remote host processor in an analog, digital or optical form.

22. The apparatus of claim 15, wherein the oxygen consumption unit comprises a mask, securable about the patient'"'"'s nose and mouth, and a sensor assembly, the sensor assembly measuring (1) a flow rate of exhaled air and oxygen content in ambient air or (2) oxygen consumption.

23. The apparatus of claim 15, wherein the processing unit computes the cardiac output result using Fick'"'"'s principle.

24. The apparatus of claim 15, wherein the implantable medical device transmits the venous oxygen saturation data to the processing unit using electromagnetic signals or acoustic signals.

25. The apparatus of claim 15, wherein the implantable medical device comprises one of a pacemaker, a pacemaker/cardioverter/defibrillator (PCD), an oxygen sensing device, or an implantable hemodynamic monitor.

26. A non-invasive cardiac monitoring method, comprising:

receiving venous oxygen saturation data from an implantable medical device coupled to an oxygen sensor;

receiving oxygen consumption data using air exhaled by a patient;

and calculating a cardiac output result using the venous oxygen saturation data, the oxygen consumption data, and arterial oxygen saturation data assumed to be about 100% or acquired using a sensor external to the patient.

27. The method of claim 26, wherein the oxygen consumption data is obtained by measuring (1) a flow rate of air exhaled by the patient and oxygen content in ambient air or (2) the patient'"'"'s oxygen consumption.

28. The method of claim 26, wherein the cardiac output result is calculated using Fick'"'"'s principle.

29. The method of claim 26, wherein the venous oxygen saturation data is received substantially simultaneously with respect to the oxygen consumption data.

30. The method of claim 26, wherein the cardiac output result is calculated substantially in real-time.

31. The method of claim 26, further comprising communicating the cardiac output result to a remote host processor or to a local output device.

32. The method of claim 26, further comprising communicating the cardiac output result to a remote host processor in response to an instruction signal produced by the remote host processor.

33. The method of claim 26, further comprising communicating the cardiac output result to a remote host processor in response to the cardiac output result exceeding a preestablished threshold.

34. The method of claim 26, wherein the implantable medical device comprises one of a pacemaker, a pacemaker/cardioverter/defibrillator (PCD), an oxygen sensing device, or an implantable hemodynamic monitor.

35. The method of claim 26, further comprising:

acquiring blood pressure data and ambient air pressure data from the implantable pressure sensor and an air pressure sensor, respectively; and

calculating hemodynamic data using the venous oxygen saturation data, oxygen consumption data, arterial oxygen saturation data, and the blood and ambient air pressure data.