Apparatus and methods for METS measurement by accelerometer and minute ventilation sensors

• US 6,273,856 B1
• Filed: 10/19/1999
• Issued: 08/14/2001
• Est. Priority Date: 10/19/1999
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Hopper, Donald L., Sun, Weimin, Jones, Bruce R., Stahl, Wyatt K.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US09/421,017
• Time in Patent Office: 665 Days
• Field of Search: 600/300, 600/509, 600/520, 600/595, 607/17, 607/29, 607/20, 482/8, 482/9
• US Class Current: 600/300
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters

Abstract

Exertion levels of a patient are measured by monitoring signals from adaptive-rate sensors such as an accelerometer and or a minute ventilation sensor; sensor data is collected for conversion into metabolic equivalent measurements. The data obtained can be used to evaluate patient physical activity levels and can be used to assess the patient'"'"'s condition and change pacing therapy or other treatments accordingly. An automatic adjustment of the adaptive-rate pacing therapy may be based on the activity levels detected by the metabolic equivalent measurements made by the pacemaker.

Claims

1. A method of measuring the metabolic equivalent (METS) relating to patient exercise comprising the steps of:

(a) affixing a physiologic sensor to the patient that produces electrical signals proportional to the patient'"'"'s activity level;

(b) processing the electrical signals; and

(c) calculating METS based upon the processed signals obtained in step (b).

2. The method of claim 1 wherein the physiologic sensor is a component of an implantable cardiac rhythm management device and the step of affixing comprises implanting the cardiac rhythm management device within the patient.

3. The method of claim 2 wherein the implantable cardiac rhythm management device comprises a rate adaptive pacemaker and further including the step of:

(a) utilizing a signal proportional to the calculated METS as a rate controlling parameter of the rate adaptive pacemaker.

4. A method of measuring the metabolic equivalent (METS) relating to patient exercise comprising the steps of:

(a) affixing one of a minute ventilation sensor and an accelerometer to the patient for producing electrical signals proportional to one of a patient'"'"'s instantaneous respiratory rate and tidal volume and physical activity;

(b) averaging the amplitude of the electrical signals over a predetermined time interval; and

(c) calculating METS as a linear regression of the average obtained in step (b).

5. The method of claim 4 wherein said one of a minute ventilation sensor and an accelerometer is a component of an implantable cardiac rhythm management device and the step of affixing comprises implanting the cardiac rhythm management device within the patient.

6. The method of claim 5 wherein the implantable cardiac rhythm management device comprises a rate adaptive pacemaker and further including the step of:

(a) utilizing a signal proportional to the calculated METS as a rate controlling parameter of the rate adaptive pacemaker.

7. A method for assessing a patient'"'"'s well-being, comprising the steps of:

a) implanting in the patient a cardiac rhythm management device having a cardiac depolarization sensor, a physiologic sensor producing electrical signals proportional to patient activity, a pulse generator for applying stimulating pulses to the heart and a microprocessor-based controller coupled to received an output from the cardiac depolarization sensor and the electrical signals from the physiologic sensor for producing delta rate signals for the pulse generator;

b) storing the delta rate signals in a memory of the microprocessor-based controller;

c) computing an average of the stored delta rate signals over a first predetermined time interval; and

d) computing in the microprocessor-based controller a metabolic equivalent (METS) as a linear regression of the computed average.

8. A method for assessing a patient'"'"'s well-being comprising the steps of:

a) implanting in the patient a cardiac rhythm management device of the type including, means for sensing cardiac depolarizing signals, means for sensing transthoracic impedance and producing an electrical signal, pulse generator means for applying cardiac stimulating signals to the patient'"'"'s heart, and a microprocessor-based controller coupled to receive the cardiac depolarizing signal and the electrical signals proportional to transthoracic impedance for producing control signals related to the patient'"'"'s minute ventilation (MV), said control signals being connected to the pulse generator means for controlling the rate at which the cardiac stimulating signals are produced;

b) recording said control signals proportional to minute ventilation in a memory of the microprocessor-based controller;

c) computing an average of said control signals over a first predetermined time interval; and

d) computing in the microprocessor-based controller a metabolic equivalent (METS) as a linear regression of said computed average.

9. The method of claim 8 wherein the linear regression of said computed average is represented by an equation

10. The method of claim 9 wherein a is in a range of from 0.014 to 0.035 and preferably about 0.0172 and where b is about 1.

11. The method of claim 8 and further including the step of:

e) recording in the memory at second predetermined intervals the maximum and the average METS values computed in step d) within an immediately preceding one of the second predetermined time intervals.

12. The method of claim 11 wherein the first predetermined intervals are measured in seconds and the second predetermined intervals in one of days and weeks.

13. The method of claim 11 and further including the step of:

f) transcutaneosly reading out the maximum and average of METS values recorded in the memory to an external monitor whereby long term history of METS levels representative of a patient'"'"'s activity patterns and changes therein become available to a physician.

14. The method of claim 8 further including the step of comparing an amplitude of the control signal to a predetermined threshold value indicative of exercise activity and determining the length of time that the amplitude of the control signal exceeds said threshold value.

15. A method of assessing a patient'"'"'s well-being, comprising the steps of:

a) implanting in the patient a cardiac rhythm management device of the type including, means for sensing cardiac depolarizing signals, an accelerometer for sensing body activity and producing electrical signals (XL) proportional thereto, a pulse generator for applying cardiac stimulating signals to the patient'"'"'s heart, a microprocessor-based controller coupled to receive the cardiac depolarizing signals and the electrical signals proportional to body activity for producing rate control signals for the pulse generator;

b) recording the rate control signals proportional to body activity (XL) in a memory of the Microprocessor-based controller;

c) computing an average of said control signals over a first predetermined time interval; and

d) computing the microprocessor-based controller a metabolic equivalent (METS) as a linear regression of said computed average.

16. The method of claim 15 wherein the linear regression of the computed average is represented by an equation

17. The method of claim 16 wherein a is in a range of from about 0.050 to 0.070 and preferably about 0.0576 and b is about 1.

18. The method of claim 15 and further including the steps of:

e) recording in the memory at second predetermined intervals the maximum and the average METS values computed in step d) within an immediately preceding one of the second predetermined intervals.

19. The method of claim 18 wherein the first predetermined intervals are measured in seconds and the second predetermined intervals are measured in one of days and weeks.

20. The method of claim 18 and further including the step of:

f) transcutaneously reading out the maximum and average METS values recorded in the memory of an external monitor whereby long-term history of METS levels representative of a patient'"'"'s activity patterns and changes therein become available to a physician.

21. The method of claim 15 and further including the step of comparing an amplitude of the control signal to a predetermined threshold value indicative of exercise activity and determining the length of time that the amplitude of the control signal exceeds said threshold value.

22. An apparatus for assessing a patient'"'"'s well-being comprising:

a) a cardiac rhythm management device having a cardiac depolarization sensor and a physiologic sensor, said physiologic sensor producing electrical signals proportional to patient activity, a pulse generator configured to apply cardiac stimulating pulses to the heart and a microprocessor-based controller connected to receive cardiac depolarization signals picked up by the cardiac depolarization sensor and the electrical signals proportional to patient activity and providing a delta rate signal to the pulse generator;

b) a memory in the microprocessor-based controller for at least temporarily storing the delta rate signals,

c) a microprocessor in the microprocessor-based controller coupled to the memory for reading out the stored delta rate signals and computing an average thereof over a first predetermined time interval; and

d) said microprocessor computing a METS value as a linear regression of the computed average.

23. The apparatus of claim 22 wherein the physiologic sensor is a transthoracic impedance sensor.

24. The apparatus of claim 23 wherein the delta rate signal is proportional to the patient'"'"'s minute ventilation (MV).

25. The apparatus of claim 24 wherein the linear regression is calculated as:

26. The apparatus of claim 25 wherein a is in a numerical value in a range of from 0.014 to 0.035 and preferably about 0.0172 and b is about 1.

27. The apparatus of claim 22 wherein the physiologic sensor is an accelerometer.

28. The apparatus of claim 27 wherein the delta rate signal is proportional to the patient'"'"'s motion.

29. The apparatus of claim 28 wherein the linear regression is calculated as:

30. The apparatus of claim 29 wherein a is a numerical value in a range of from about 0.050 to 0.070 and preferably about 0.0576 and b is about 1.

31. The apparatus of claim 22 and further including:

e) means for storing in said memory at second predetermined time intervals the maximum and the average METS values computed in the microprocessor within an immediately preceding one of the second predetermined time intervals.

32. The apparatus of claim 31 and further including:

f) a telemetry link in the cardiac rhythm management device adapted to transcutaneously read out from the memory said maximum and average METS values to an external monitor.

33. An apparatus for assessing a patient'"'"'s well-being comprising:

a) an implantable electronics module having a physiologic sensor producing electrical signals proportional to a patient'"'"'s physical activity, a microprocessor coupled to receive the electrical signals from the sensor and programmed to solve for a METS value a linear regression formula having as an independent variable an average over a predetermined time interval of the electrical signal, and a telemetry channel.

b) an external monitor adapted to communicate with the implantable module over the telemetry channel.

34. The apparatus of claim 33 wherein the physiologic sensor includes an accelerometer.

35. The apparatus of claim 34 wherein the physiologic sensor produces said electrical signal, said electrical being proportional to the patient'"'"'s minute ventilation.

36. An apparatus for measuring the metabolic equivalent (METS) relating to patient exercise comprising:

(a) an accelerometer affixed to the patient for producing electrical signals proportional to the patient'"'"'s instantaneous activity levels;

(b) a circuit for averaging an amplitude of the electrical signals over a predetermined time interval; and

(c) means for calculating a METS value as a linear regression of the averaged amplitude of the electrical signals.

37. The apparatus of claim 36 wherein the accelerometer is a component of an implantable cardiac rhythm management device.

38. The apparatus of claim 37 wherein the cardiac rhythm management device comprises a rate adaptive pacemaker and the METS value comprises a rate controlling parameter for the rate adaptive pacemaker.

39. An apparatus for measuring the metabolic equivalent (METS) relating to a patient'"'"'s exercise comprising:

(a) a minute ventilation sensor affixed to the patient for producing electrical signals having an amplitude proportional thereto;

(b) a circuit for averaging the amplitude of the electrical signals over a predetermined time interval; and

(c) means for calculating a METS value as a linear regression of the averaged amplitude of the electrical signals.

40. The apparatus of claim 39 wherein the minute ventilation sensor is a component of an implantable cardiac rhythm management device.

41. The apparatus of claim 40 wherein the cardiac rhythm management device comprises a rate adaptive cardiac pacemaker and the METS value comprises a rate controlling parameter for the rate adaptive pacemaker.