Methods and systems for measuring cardiac parameters

• US 7,204,798 B2
• Filed: 01/23/2004
• Issued: 04/17/2007
• Est. Priority Date: 01/24/2003
• Status: Active Grant

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Biomedical, Inc. (Otsuka Holdings Company Limited)
• Inventors: Zdeblick, Mark, Ruggio, Joseph M.
• Primary Examiner(s): Pezzuto; Robert
• Assistant Examiner(s): JOHNSON, SHEVON ELIZABETH
• Application Number:
  US10/764,127
• Publication Number:
  US 20040254483A1
• Time in Patent Office: 1,180 Days
• Field of Search: 600/17, 600/508, 600/587, 600/561, 600/523
• US Class Current: 600/17
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/6882 Anchoring means

Abstract

Methods and systems of the present invention provide for measurement of various cardiac parameters. Methods generally involve causing a change in volume and/or pressure in a heart chamber, measuring the change, and calculating at least one cardiac parameter based on the change. Systems typically include at least one actuator, at least one sensor, and a catheter or other device for positioning at least partially in a heart chamber. In some embodiments, the system may also include a controller, such as a computer or other processor, an external actuator, an external sensor, and/or an ECG device. Methods and systems of the invention may be used to more accurately diagnose cardiac conditions in order to make more informed treatment decisions.

Claims

1. A method for measuring a cardiac performance parameter, the method comprising repeating over a series of two or more consecutive heart cycles:

causing a change in at least one of volume and pressure in a heart chamber at a selected time during a heart cycle;

measuring a change in at least one characteristic of the heart chamber which occurs in response to the change in at least one of volume and pressure; and

calculating at least one cardiac performance parameter based on a ratio of the measured change in the characteristic to the caused change.

2. A method as in claim 1, wherein causing the change comprises introducing a volume of fluid into the heart chamber during diastole.

3. A method as in claim 2, wherein introducing the volume of fluid comprises releasing the fluid within the heart chamber via one or more apertures in a catheter positioned in the chamber.

4. A method as in claim 2, wherein introducing the volume of fluid comprises inflating an expandable balloon coupled with a catheter positioned in the heart chamber.

5. A method as in claim 4, wherein inflating the balloon comprises:

inflating the balloon during systole of the heart; and

deflating the balloon during diastole of the heart immediately following the systole.

6. A method as in claim 4, wherein inflating the balloon comprises:

inflate the balloon during diastole of the head; and

deflating the balloon during systole of the heart immediately following the diastole.

7. A method as in claim 2, wherein introducing the volume of fluid comprises:

inflating a balloon within the heart chamber during systole;

deflating the balloon during diastole immediately following the systole; and

releasing an amount of fluid within the heart chamber during the diastole.

8. A method as in claim 7, wherein the balloon is deflated by a volume equal to the amount of the released fluid.

9. A method as in claim 7, wherein the balloon is deflated by a volume greater than the amount of the released fluid.

10. A method as in claim 1, wherein causing the change comprises activating a hydrophone at least once during diastole.

11. A method as in claim 10, wherein activating comprises activating the hydrophone at a frequency of about 200 Hz.

12. A method as in claim 10, wherein activating comprises activating the hydrophone at a frequency of about 500 Hz.

13. A method as in claim 10, wherein activating comprises activating the hydrophone at a frequency of about 1000 Hz.

14. A method as in claim 1, wherein causing the change comprises inducing a paroxysmal ventricular contraction.

15. A method as in claim 14, wherein the paroxysmal ventricular contraction is induced by electrical stimulation.

16. A method as in claim 1, further comprising measuring the heart cycle using an electrocardiogram device, wherein the selected time during the heart cycle is selected using the electrocardiogram measurement.

17. A method as in claim 1, further comprising measuring the heart cycle using at least one sensor on a catheter positioned in the heart chamber, wherein the selected time during the heart cycle is selected using the sensor measurement.

18. A method as in claim 1, wherein the change in the cardiac characteristic is measured immediately after causing a change in at least one of volume and pressure.

19. A method as in claim 1, wherein the change in the cardiac characteristic is measured during at least a portion of the heart cycle after the change in at least one of the volume and pressure.

20. A method as in claim 1, wherein measuring the change comprises measuring a change in at least one pressure within the heart chamber.

21. A method as in claim 20, wherein measuring the change in pressure comprises measuring a change in end-diastolic pressure and a change in end-systolic pressure.

22. A method as in claim 21, wherein calculating the at least one parameter comprises calculating a cardiac pressure gain, comprising:

calculating a first difference between a first end-systolic pressure and a second end-systolic pressure;

calculating a second difference between a first end-diastolic pressure and a second end-diastolic pressure; and

dividing the first difference by the second difference.

23. A method as in claim 22, further comprising providing at least one of the end-diastolic pressures, the end-systolic pressures and the cardiac pressure gain for display on a display device.

24. A method as in claim 23, wherein the providing step comprises providing data in the form of a plot, with at least one end-diastolic pressure on one axis of the plot and at least one end-systolic pressure on a perpendicular axis of the plot.

25. A method as in claim 20, wherein measuring the change comprises measuring a change in left ventricular end-diastolic pressure and a change in left ventricular end-systolic pressure.

26. A method as in claim 1, wherein measuring the change comprises measuring a change in at least one volume within the heart chamber.

27. A method as in claim 26, wherein measuring the change comprises measuring a change in end-diastolic volume and a change in end-systolic volume.

28. A method as in claim 27, wherein calculating the at least one parameter comprises calculating a volume reserve comprising:

calculating a first difference between a first end-systolic volume and a second end-systolic volume;

calculating a second difference between a first end-diastolic volume and a second end-diastolic volume; and

dividing the first difference by the second difference.

29. A method as in claim 28, further comprising providing at least one of the end-diastolic volumes, the end-systolic volumes and the volume reserve for display on a display device.

30. A method as in claim 29, wherein the providing step comprises providing data in the form of a plot, with at least one end-diastolic volume on one axis of the plot and at least one end-systolic volume on a perpendicular axis of the plot.

31. A method as in claim 27, wherein measuring the change comprises measuring a change in a left ventricular end-diastolic volume and a change in a left ventricular end-systolic volume.

32. A method as in claim 1, wherein measuring the change comprises measuring a change in at least one pressure and a change in at least one volume within the heart chamber.

33. A method as in claim 32, wherein measuring the change comprises measuring a change in end-diastolic volume and a change in end-diastolic pressure.

34. A method as in claim 33, further comprising providing pressure and volume data as a plot, with at least one volume on one axis of the plot and at least one volume on a perpendicular axis of the plot.

35. A method as in claim 33, wherein calculating the at least one parameter comprises calculating a lusitropic stiffness of the heart chamber, comprising:

calculating a first difference between a second end-diastolic pressure and a first end-diastolic pressure;

calculating a second difference between a second end-diastolic volume and a first end-diastolic volume; and

dividing the first difference by the second difference.

36. A method as in claim 35, further comprising providing at least one of the volumes, the pressures and the lusitropic stiffness for display on a display device.

37. A method as in claim 33, wherein calculating the at least one parameter comprises calculating a lusitropic compliance of the head chamber, comprising:

calculating a first difference between a second end-diastolic volume and a first end-diastolic volume;

calculating a second difference between a second end-diastolic pressure and a first end-diastolic pressure; and

dividing the first difference by the second difference.

38. A method as in claim 37, further comprising providing at least one of the volumes, the pressures and the lusitropic compliance for display on a display device.

39. A method as in claim 32, wherein measuring the change comprises measuring a change in end-systolic volume and a change in end-systolic pressure.

40. A method as in claim 39, further comprising providing volume and pressure data as a plot, with at least one volume on one axis of the plot and at least one volume on a perpendicular axis of the plot.

41. A method as in claim 39, wherein calculating the at least one parameter comprises calculating an inotropic stiffness of the head chamber, comprising;

calculating a first difference between a second end-systolic pressure and a first end-systolic pressure;

calculating a second difference between a second end-systolic volume and a first end-systolic volume; and

dividing the first difference by the second difference.

42. A method as in claim 41, further comprising providing at least one of the volumes, the pressures and the inotropic stiffness for display on a display device.

43. A method as in claim 39, wherein calculating the at least one parameter comprises calculating an inotropic compliance of the head chamber, comprising:

calculating a first difference between a second end-systolic volume and a first end-systolic volume;

calculating a second difference between a second end-systolic pressure and a first end-systolic pressure; and

dividing the first difference by the second difference.

44. A method as in claim 43, further comprising providing at least one of the volumes, the pressures and the inotropic compliance for display on a display device.

45. A method as in claim 32, wherein the measuring and calculating steps comprise:

continuously measuring a pressure and volume in the heart chamber during a heart cycle;

calculating a first integral of the pressure as a function of volume as the volume increases due to expansion of the ventricle;

calculating a second integral of the pressure as a function of volume as the volume decreases due to contraction of the ventricle; and

calculating a myocardial work of the heart chamber by subtracting the second integral from the first integral.

46. A method as in claim 32, wherein the measuring and calculating steps comprise:

continuously measuring a pressure and volume in the heart chamber during a heart cycle;

calculating a first integral of the product of the pressure and the volume as the volume increases due to expansion of the ventricle;

calculating a second integral of the product of the pressure and the volume as the volume decreases due to contraction of the ventricle; and

calculating a first moment of myocardial work of the heart chamber by subtracting the second integral from the first integral.

47. A method as in claim 45, further comprising:

calculating a body surface are; and

calculating a myocardial work index by dividing the myocardial work by the body surface area.

48. A method as in claim 45, further comprising:

calculating a stroke ejection period by calculating the time when the velocity in the aorta begins to increase from zero to the time when the velocity in the aorta first returns to zero; and

calculating a myocardial power by dividing the myocardial work by the stroke ejection period.

49. A method as in claim 48, further comprising calculating a body surface area;

and calculating a myocardial power index by dividing myocardial power by body surface area.

50. A method as in claim 48, further comprising calculating a stroke volume;

and calculating a myocardial power requirement parameter by dividing myocardial power by stroke volume.

51. A method as in claim 45, further comprising:

calculating a first myocardial work for the first heart cycle;

changing the end-diastolic volume and pressure;

calculating a second myocardial work for a second heart cycle;

measuring a first end-diastolic pressure for the first heart cycle and a second end-diastolic pressure for the second heart cycle; and

calculating a myocardial reserve by dividing a difference between the second and first myocardial works by a difference between the second and the first end-diastolic pressures.

52. A method as in claim 51, further comprising:

calculating a body surface area; and

calculating a myocardial reserve index by dividing the myocardial reserve by the body surface area.

53. A method as in claim 45, wherein the myocardial work is calculated for a left ventricle of a heart.

54. A method as in claim 45, wherein the myocardial work is calculated for a right ventricle of a heart.

55. A method as in claim 45, further comprising:

calculating a first myocardial power for the first heart cycle;

changing the end-diastolic volume and pressure;

calculating a second myocardial power for a second heart cycle;

measuring a first end-diastolic pressure for the first heart cycle and a second end-diastolic pressure for the second heart cycle; and

calculating a myocardial power reserve by dividing a difference between the second and first myocardial powers by a difference between the second and the first end-diastolic pressures.

56. A method as in claim 55, further comprising:

calculating a body surface area; and

calculating a myocardial power reserve index by dividing the myocardial power reserve by the body surface area.

57. A method as in claim 1, further comprising:

measuring a change in at least one flow rate of blood flowing out of the heart chamber which occurs in response to the volume and/or pressure change; and

calculating at least one flow-related parameter of the heart chamber based on a ratio of the measured change in the flow rate to the volume and/or pressure change.

58. A method as in claim 57, wherein measuring the change in the flow rate comprises measuring at least one flow rate in an aorta.

59. A method as in claim 57, wherein measuring the change in the flow rate comprises measuring at least one flow rate in at least one pulmonary artery.

60. A method as in claim 57, wherein calculating the flow-related parameter comprises calculating at least one stroke volume of a heart from which the flow rate is measured, the method further comprising:

estimating a cardiac output for the heart;

measuring a rate of the heart;

calculating a first ratio by dividing the estimated cardiac output by the heart rate;

calculating a first integral of the flow rate over a number of heart cycles;

calculating a second ratio by dividing the integral by the number of heart cycles;

calculating a scaling factor by dividing the first ratio by the second ratio;

calculating a second integral of the flow rate over a selected heart cycle; and

calculating the stroke volume by multiplying the second integral by the scaling factor.

61. A method as in claim 60, further comprising:

measuring a body surface area; and

calculating a stroke volume index by dividing the stroke volume by the body surface area.

62. A method as in claim 60, wherein the cardiac output is estimated using at least one of Fick'"'"'s method and a dilution method.

63. A method as in claim 60, further comprising determining a calculated cardiac output by dividing the stroke volume by a time of duration of one of the heart cycles.

64. A method as in claim 63, further comprising:

measuring a body surface area; and

calculating a cardiac index by dividing the calculated cardiac output by the body surface area.

65. A method as in claim 63, further comprising:

determining a first calculated cardiac output and a second calculated cardiac output for first and second heart cycles;

measuring first end-diastolic pressure and a second end-diastolic pressure for the first and second head cycles; and

calculating a cardiac reserve by dividing a difference between the second and first calculated cardiac outputs by a difference between the second and first end-diastolic pressures.

66. A method as in claim 65, further comprising:

measuring a body surface area; and

calculating a cardiac reserve index by dividing the calculated cardiac reserve by the body surface area.

67. A method as in claim 60, further comprising:

calculating a first stroke volume and a second stroke volume for first and second cardiac cycles;

measuring first end-diastolic pressure and a second end-diastolic pressure for the first and second heart cycles; and

calculating a stroke reserve by dividing a difference between the second and first calculated stroke volumes by a difference between the second and first end-diastolic pressures.

68. A method as in claim 67, further comprising:

measuring a body surface area; and

calculating a stroke reserve index by dividing the calculated stroke reserve by the body surface area.

69. A method as in claim 60, further comprising:

measuring an average systolic pressure in at least one outflow artery adjacent the heart;

measuring an average diastolic pressure in the heart chamber;

calculating a difference between the average systolic pressure and the average diastolic pressure; and

calculating a stroke work by multiplying the difference by the stroke volume.

70. A method as in claim 69, further comprising:

measuring a body surface area; and

calculating a stroke work index by dividing the calculated stroke work by the body surface area.

71. A method as in claim 69, further comprising:

calculating a first stroke work and a second stroke work for first and second cardiac cycles;

measuring first end-diastolic pressure and a second end-diastolic pressure for the first and second heart cycles; and

calculating a stroke work reserve by dividing a difference between the second and first calculated stroke works by a difference between the second and first end-diastolic pressures.

72. A method as in claim 71, further comprising:

measuring a body surface area; and

calculating a stroke work reserve index by dividing the calculated stroke work reserve by the body surface area.

73. A method as in claim 69, wherein the at least one outflow artery comprises an aorta.

74. A method as in claim 69, wherein the at least one outflow artery comprises at least one pulmonary artery.

75. A method as in claims 45 and 69, further comprising calculating a cardiac efficiency by dividing the stroke work by the myocardial work.

76. A method as in claim 60, further comprising:

calculating a first stroke volume and a second stroke volume for first and second cardiac cycles;

measuring first end-diastolic volume and a second end-diastolic volume for the first and second heart cycles; and

calculating a cardiac amplification by dividing a difference between the second and first calculated stroke volumes by a difference between the second and first end-diastolic volumes.

77. A method as in claim 60, further comprising calculating a first difference between a second product of volume and pressure and a first product of volume and pressure, said second volume and pressure measured shortly after the first;

calculating a determination of the incremental stroke volume which is the product of the scaling factor and the integral of the velocity in the proximal artery between the first and second times;

calculating the period of time between the first measurement and the second;

calculating a third product between the incremental stroke volume and the period of time; and

calculating an ejection contractility parameter by dividing the first difference by the third product.