Thoracic impedance detection with blood resistivity compensation

• US 20060041280A1
• Filed: 08/19/2004
• Published: 02/23/2006
• Est. Priority Date: 08/19/2004
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Stahmann, Jeffrey E., Moon, Boyce, Hatlestad, John
• Granted Patent: US 7,387,610 B2
• Time in Patent Office: Days
• US Class Current: 607/17
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• 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 1/36521 the parameter being derived from measurement of an electrical impedance

Abstract

This document discusses, among other things, a cardiac rhythm management device or other implantable medical device that uses thoracic impedance to determine how much fluid is present in the thorax, such as for detecting or predicting congestive heart failure, pulmonary edema, pleural effusion, hypotension, or the like. The thoracic fluid amount determined from the thoracic impedance is compensated for changes in blood resistivity, which may result from changes in hematocrit level or other factors. The blood-resistivity-compensated thoracic fluid amount can be stored in the device or transmitted to an external device for storage or display. The blood-resistivity-compensated thoracic fluid amount can also be used to adjust a cardiac pacing, cardiac resynchronization, or other cardiac rhythm management or other therapy to the patient. This document also discusses applications of the devices and methods for predicting or indicating anemia.

Claims

1. A method comprising:

detecting a thoracic impedance signal of a thorax of a subject;

detecting a blood resistivity signal; and

determining a thoracic fluid indication using the thoracic impedance signal, the determining the thoracic fluid indication including using the blood resistivity signal to reduce or eliminate an effect of a change in the blood resistivity on the thoracic fluid indication.

2. The method of claim 1, further comprising filtering the thoracic impedance signal to obtain a near-DC thoracic impedance signal, and in which the thoracic fluid indication is generated at least in part by using the near-DC thoracic impedance signal.

3. The method of claim 2, in which the filtering the thoracic impedance signal includes attenuating or removing frequency components above about 0.05 Hz.

4. The method of claim 2, in which the filtering the thoracic impedance signal includes attenuating or removing a cardiac stroke component of the thoracic impedance signal.

5. The method of claim 2, in which the filtering the thoracic impedance signal includes attenuating or removing a respiration component of the thoracic impedance signal.

6. The method of claim 2, in which the filtering the thoracic impedance signal includes attenuating or removing a posture component of the thoracic impedance signal.

7. The method of claim 2, in which the filtering the thoracic impedance signal includes using a variable lowpass cutoff frequency filter.

8. The method of claim 1, in which the detecting the thoracic impedance signal and the determining the thoracic fluid indication are performed using an implantable medical device.

9. The method of claim 1, in which the detecting the thoracic impedance signal comprises:

delivering a test current from first and second implantable electrodes; and

measuring a resulting voltage in response to the test current from third and fourth implantable electrodes.

10. The method of claim 9, in which at least one of the first and second implantable electrodes is the same electrode as the third and fourth implantable electrodes.

11. The method of claim 9, in which the first and second implantable electrodes are different electrodes from the third and fourth implantable electrodes.

12. The method of claim 9, in which the delivering the test current includes delivering a carrier signal.

13. The method of claim 1, in which the detecting the thoracic impedance signal includes using at least one cardiovascular electrode.

14. The method of claim 1, in which the detecting the thoracic impedance signal includes using at least one electrode located on a housing of an implantable medical device.

15. The method of claim 1, in which the detecting the thoracic impedance signal includes using at least one electrode located on a substantially electrically insulating header of an implantable medical device.

16. The method of claim 1, in which the detecting the blood resistivity signal includes using first and second intravascular electrodes.

17. The method of claim 1, in which the detecting the blood resistivity signal includes:

delivering a test current between first and second electrodes, in which the first and second electrodes are both located within single heart chamber or blood vessel; and

measuring a resulting voltage in response to the test current.

18. The method of claim 1, in which the detecting the blood resistivity includes measuring a volume of blood that is substantially independent of a degree of fluid present in the thorax.

19. The method of claim 1, in which the detecting the blood resistivity includes measuring the blood resistivity at like times during at least one of a cardiac cycle and a respiratory cycle.

20. The method of claim 1, in which the determining a thoracic fluid indication using the thoracic impedance signal includes:

measuring a first thoracic impedance value at a first time;

measuring a first blood resistivity value at a second time that is close to the first time;

measuring a second thoracic impedance value at a third time; and

measuring a second blood resistivity value at a fourth time that is close to the third time; and

normalizing, using the first and second blood resistivity values, the second thoracic impedance value to the first thoracic impedance value.

21. The method of claim 20, in which the normalizing includes multiplying the second thoracic impedance value by a ratio of the first and second blood resistivity values.

22. The method of claim 1, in which the determining a thoracic fluid indication using the thoracic impedance signal includes:

measuring a baseline first blood resistivity value;

measuring a first thoracic impedance value and a corresponding second blood resistivity value; and

computing a second thoracic impedance value using the first thoracic impedance value and the first and second blood resistivity values.

23. The method of claim 22, in which the computing the second thoracic impedance value includes multiplying the first thoracic impedance value by a ratio of the first blood resistivity value to the second blood resistivity value.

24. The method of claim 1, further comprising:

storing a history of thoracic fluid measurements; and

determining whether heart failure decompensation is present using the history of thoracic fluid measurements to determine whether a change in thoracic fluid has occurred.

25. The method of claim 1, further comprising:

storing a history of thoracic fluid measurements; and

predicting heart failure decompensation using the history of the thoracic fluid measurements to determine whether a change in thoracic fluid has occurred.

26. The method of claim 1, further comprising:

storing a history of thoracic fluid measurements; and

determining whether pulmonary edema is present using the history of thoracic fluid measurements to determine whether a change in thoracic fluid has occurred.

27. The method of claim 1, further comprising:

storing a history of thoracic fluid measurements; and

predicting pulmonary edema using the history of thoracic fluid measurements to determine whether a change in thoracic fluid has occurred.

28. The method of claim 1, further comprising:

storing a history of thoracic fluid measurements; and

determining whether pleural effusion is present using the history of thoracic fluid measurements to determine whether a change in thoracic fluid has occurred.

29. The method of claim 1, further comprising:

storing a history of thoracic fluid measurements; and

predicting pleural effusion using the history of thoracic fluid measurements to determine whether a change in thoracic fluid has occurred.

30. The method of claim 1, further including transmitting information about the thoracic fluid indication from an implantable medical device to an external device.

31. The method of claim 30, further including displaying the information about the thoracic fluid indication on the external device.

32. The method of claim 30, further including storing the information about the thoracic fluid indication in the external device.

33. The method of claim 1, further including providing therapy to the subject, the therapy determined at least in part using the thoracic fluid indication.

34. The method of claim 1, in which the using the blood resistivity signal to reduce or eliminate an effect of a change in the blood resistivity on the thoracic fluid indication includes:

measuring a posture of the patient;

storing a first baseline blood resistivity corresponding to a first posture;

storing a second baseline blood resistivity corresponding to a second posture that is different from the first posture; and

compensating the thoracic fluid indication by selecting and using the one of the first and second baseline blood resistivities that corresponds to the then-current posture of the patient.

35. The method of claim 34, in which the first posture is an upright posture and the second posture is a recumbent posture.

36. A method of using an implantable medical device, the method comprising:

detecting a thoracic impedance signal of a thorax of a subject using implantable electrodes to deliver a test current and measure a responsive voltage;

detecting a blood resistivity signal, within a heart chamber or blood vessel, from a volume of blood that is substantially independent of a cardiac cycle and a respiratory cycle;

filtering the thoracic impedance signal to substantially remove frequency components above 0.05 Hz to obtain a near-DC thoracic impedance signal; and

determining a thoracic fluid indication using the thoracic impedance signal, the determining the thoracic fluid indication including compensating the thoracic impedance signal for changes in blood resistivity.

37. The method of claim 36, in which the compensating comprises multiplying a thoracic impedance signal value by a ratio of a baseline blood resistivity to a blood resistivity measured close in time to a time when the thoracic impedance signal value was measured.

38. The method of claim further comprising:

storing a history of thoracic fluid measurements; and

determining whether at least one of heart failure decompensation, pulmonary edema, and pleural effusion is present using the history of thoracic fluid measurements to determine whether a change in thoracic fluid has occurred.

39. A system comprising:

an implantable medical device, including;

a thoracic impedance measurement circuit, to provide a thoracic impedance signal;

a blood resistivity measurement circuit, to provide a blood resistivity signal; and

a controller, coupled to the blood resistivity measurement circuit, the controller operable to determine a thoracic fluid indication using the filtered thoracic impedance signal, including using the blood resistivity signal to reduce or eliminate an effect of a change in the blood resistivity on the thoracic fluid indication.

40. The system of claim 39, in which the thoracic impedance measurement circuit includes:

a test current circuit to deliver a test current to first and second implantable electrodes; and

a voltage measurement circuit to measure a resulting voltage between third and fourth implantable electrodes.

41. The system of claim 40, further including the at least one of the first and second implantable electrodes and at least one of the third and fourth implantable electrodes, and in which at least one of the first and second implantable electrodes is the same electrode as the third and fourth implantable electrodes.

42. The system of claim 40, further including the at least one of the first and second implantable electrodes and at least one of the third and fourth implantable electrodes, and in which the first and second implantable electrodes are different electrodes from the third and fourth implantable electrodes.

43. The system of claim 40, in which the test current circuit includes a carrier signal generator circuit.

44. The system of claim 39, further including at least one cardiovascular leadwire electrode to detect the thoracic impedance signal.

45. The system of claim 39, in which the implantable medical device includes a housing, and in which the housing includes at least one electrode to detect the thoracic impedance signal.

46. The system of claim 45, in which implantable medical device includes at least one substantially electrically insulating header attached to the housing, and in which the header includes at least one electrode to detect the thoracic impedance signal.

47. The system of claim 39, further comprising first and second cardiovascular electrodes to detect the blood resistivity signal.

48. The system of claim 47, in which the first and second cardiovascular electrodes are arranged with respect to each other to be disposed within the same heart chamber or blood vessel.

49. The system of claim 47, further including a sense amplifier to detect intrinsic heart signals corresponding to each cardiac cycle of a subject, and in which the blood resistivity measurement circuit includes a synchronization circuit to synchronize blood resistivity measurements to at least one of (1) like phases of different cardiac cycles;

and (2) like phases of different respiration cycles.

50. The system of claim 39, further including a frequency selective filter circuit, to receive the thoracic impedance signal, the frequency selective filter circuit providing a near-DC filtered thoracic impedance signal.

51. The system of claim 50, in which the filter circuit includes a lowpass filter circuit including at least one lowpass pole at a frequency of about 0.05 Hz.

52. The system of claim 50, in which the filter circuit includes a lowpass filter circuit including at least one lowpass pole at a frequency that attenuates or removes a cardiac stroke component of the thoracic impedance signal.

53. The system of claim 50, in which the filter circuit includes a lowpass filter circuit including at least one lowpass pole at a frequency that attenuates or removes a respiration component of the thoracic impedance signal.

54. The system of claim 50, in which the filter circuit includes a lowpass filter circuit including at least one variable-frequency lowpass pole.

55. The system of claim 39, further comprising:

a posture sensor, to provide a posture signal; and

a posture compensation module, operable to compensate the thoracic fluid indication using the posture signal.

56. The system of claim 55, in which the posture compensation module includes different baseline blood resistivity measurements corresponding to different postures.

57. The system of claim 39, in which the controller includes:

a first memory location to store a first thoracic impedance value measured at a first time;

a second memory location to store a first blood resistivity value measured at a second time that is close to the first time;

a third memory location to store a second thoracic impedance value measured at a third time; and

a fourth memory location to store a second blood resistivity value measured at a fourth time that is close to the second time; and

a normalization module to normalize, using the first and second blood resistivity values, the second thoracic impedance value to the first thoracic impedance value.

58. The system of claim 57, in which the normalization module includes an arithmetic logic unit (ALU) that multiplies the second thoracic impedance value by a ratio of the first and second blood resistivity values.

59. The system of claim 39, in which the controller circuit includes:

an averaging circuit to measure a first blood resistivity value;

a first memory location to store a first thoracic impedance value;

a second memory location to store a second blood resistivity value that corresponds to the first thoracic impedance value; and

in which the controller circuit is operable to compute a second thoracic impedance value using the first thoracic impedance value and the first and second blood resistivity values.

60. The system of claim 59, in which the controller includes a multiplier circuit to multiply the first thoracic impedance value by a ratio of the first blood resistivity value to the second blood resistivity value.

61. The system of claim 39, further comprising:

a memory configured to store a history of thoracic fluid measurements; and

a heart failure decompensation detection or prediction module operable to determine whether heart failure decompensation is present or likely to occur using the history of thoracic fluid measurements to determine whether a change in thoracic fluid has occurred.

62. The system of claim 61, in which the memory and the decompensation detection or prediction module are located in the implantable medical device.

63. The system of claim 61, in which the memory and the decompensation detection or prediction module are located in an external device.

64. The system of claim 39, further comprising:

a memory configured to store a history of thoracic fluid measurements; and

a pulmonary edema detection or prediction module operable to determine whether pulmonary edema is present or likely to occur using the history of thoracic fluid measurements to determine whether a change in thoracic fluid has occurred.

65. The system of claim 64, in which the memory and the pulmonary edema detection or prediction module are located in the implantable medical device.

66. The system of claim 64, in which the memory and the pulmonary edema detection or prediction module are located in an external device.

67. The system of claim 39, further comprising:

a memory configured to store a history of thoracic fluid measurements; and

a pleural effusion detection or prediction module operable to determine whether pleural effusion is present or likely to occur using the history of thoracic fluid measurements to determine whether a change in thoracic fluid has occurred.

68. The system of claim 67, in which the memory and the pleural effusion detection or prediction module are located in the implantable medical device.

69. The system of claim 67, in which the memory and the pleural effusion detection or prediction module are located in an external device.

70. The system of claim 39, further including an external device operable to be communicatively coupled to the implantable medical device to receive information about the thoracic fluid indication from the implantable medical device.

71. The system of claim 70, in which the external device includes a display device to display the information about the thoracic fluid indication.

72. The system of claim 70, in which the external device includes a storage device to store the information about the thoracic fluid indication.

73. The system of claim 39, further including a therapy circuit, coupled to the controller, the therapy circuit operable to provide a therapy to a subject, the therapy determined at least in part using the thoracic fluid indication from the controller.

74. A system comprising:

an implantable medical device, including;

a thoracic impedance measurement circuit, to provide a thoracic impedance signal;

a frequency-selective filter circuit, coupled to the thoracic impedance measurement circuit to receive the thoracic impedance signal, the frequency selective filter circuit including at least one lowpass pole providing a near-DC filtered thoracic impedance signal, the at least one lowpass pole substantially attenuating or removing at least one of a heart contraction component and a respiration component of the thoracic impedance signal;

a blood resistivity measurement circuit, to provide a blood resistivity signal from which a blood resistivity measurement is obtained, the blood resistivity measurement being substantially independent of a variation resulting from heart contractions, respiration, and degree of thoracic fluid; and

a controller, coupled to the filter circuit and the blood resistivity measurement circuit, the controller operable to determine a thoracic fluid indication using the filtered thoracic impedance signal, including using the blood resistivity signal to reduce or eliminate an effect of a change in the blood resistivity on the thoracic fluid indication, the thoracic fluid indication determined by multiplying a thoracic impedance signal value by a ratio of a baseline blood resistivity to a blood resistivity measured close in time to a time when the thoracic impedance signal value was measured.

75. The system of claim 74, further comprising:

a memory storage device operable to store a history of thoracic fluid measurements; and

means for determining whether at least one of heart failure decompensation, pulmonary edema, and pleural effusion is present using the history of thoracic fluid measurements to determine whether a change in thoracic fluid has occurred.

76. A system comprising:

an implantable medical device, including;

a thoracic impedance measurement circuit, to provide a thoracic impedance signal;

a frequency selective filter circuit, coupled to the thoracic impedance measurement circuit to receive the thoracic impedance signal, the frequency selective filter circuit providing a near-DC filtered thoracic impedance signal;

a blood resistivity measurement circuit, to provide a blood resistivity signal;

means for determining a thoracic fluid indication using the filtered thoracic impedance signal; and

means for reducing or eliminating an effect of a change in blood resistivity on the thoracic fluid indication.

77. The system of claim 76, further comprising:

a memory storage device operable to store a history of thoracic fluid measurements; and

means for determining whether at least one of heart failure decompensation, pulmonary edema, and pleural effusion is present using the history of thoracic fluid measurements to determine whether a change in thoracic fluid has occurred.

78. A method comprising:

detecting a first blood resistivity at a first time using at least one implanted intravascular or intracardiac electrode in a patient;

detecting a second blood resistivity at a second time using the at least one implanted intravascular or intracardiac electrode;

comparing the second blood resistivity to the first blood resistivity; and

if the second blood resistivity is less than the first blood resistivity by at least a threshold value, then declaring an indication or prediction of anemia to be present in the patient.

79. The method of claim 78, in which the detecting the first blood resistivity and the detecting the second blood resistivity are performed in the same blood vessel or heart chamber.

80. The method of claim 78, in which the detecting the first blood resistivity and the detecting the second blood resistivity are performed under like conditions with respect to at least one of a cardiac cycle, a respiratory cycle, a posture, and a circadian cycle.

81. The method of claim 78, further comprising communicating an indication of anemia predicted or anemia present to an external device.

82. A system comprising:

an implantable medical device, including;

first and second electrodes located within the same blood vessel or heart chamber;

a blood resistivity measurement circuit, to provide a blood resistivity signal obtained between the first and second electrodes at different first and second times; and

a controller, coupled to the blood resistivity measurement circuit, the controller operable to determine an indication or prediction of anemia by comparing a current blood resistivity to a stored baseline blood resistivity value.

83. The system of claim 82, in which the blood resistivity measurement circuit includes:

a test current circuit to deliver a test current to first and second implantable electrodes; and

a voltage measurement circuit to measure a resulting voltage between third and fourth implantable electrodes.

84. The system of claim 82, further comprising a heart signal sensing circuit configured to synchronize the first and second times to like portions of different cardiac cycles.

85. The system of claim 82, further comprising a thoracic impedance measurement circuit configured to synchronize the first and second times to like portions of different respiration cycles.

86. The system of claim 82, further comprising a posture sensor and a posture compensation module configured to store different baseline blood resistivities corresponding to different postures obtained from the posture sensor.