Apparatus and Method for Programming a Pacemaker

• US 20090069859A1
• Filed: 07/21/2005
• Published: 03/12/2009
• Est. Priority Date: 07/21/2004
• Status: Active Grant

• Current Assignee: Imperial Innovations Limited (Imperial College London)
• Original Assignee: Imperial College Innovations Ltd. (Imperial College London)
• Inventors: Wilson, Keith, Whinnett, Zachary Ian, Francis, Darrel P., Mayet, Jamil, Davies, Justin E. R.
• Granted Patent: US 8,688,215 B2
• Time in Patent Office: Days
• US Class Current: 607/30
• CPC Class Codes: A61B 5/02241 of small dimensions, e.g. adapted to fingers
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/7207 of noise induced by motion artifacts
• CPC Class Codes: A61B 5/721 using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured
• 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 1/37235 Aspects of the external programmer

Abstract

A pacemaker optimising apparatus comprising: a component (4) which noninvasively or invasively monitors a haemodynamic measurement continuously in an individual and a processor (15) for receiving the haemodynamic measure and generating a pacemaker programming signal in response to this. There is also provided a communication device (17) for sending the pacemaker programming signal to the control system of the pacemaker (2). There is also a method for an efficient process by which this apparatus can automatically use the haemodynamic measurements to determine the ideal settings for a particular pacemaker in a particular individual, and to updates the pacemaker'"'"'s settings accordingly.

Claims

1. A pacemaker programming apparatus comprising:

a non-invasive monitoring device capable of determining a haemodynamic measure of an individual at each heart beat of the individual and generating a haemodynamic measure signal related to the haemodynamic measure;

a processor for receiving the haemodynamic measure signal and generating a pacemaker programming signal in response to the haemodynamic measure signal; and

a communication device for sending the pacemaker programming signal to a pacemaker.

2. The pacemaker programming apparatus according to claim 1 wherein the monitoring device comprises:

a contractible cuff for receiving a body extremity of an individual;

a light source directable upon a body extremity received in the contractible cuff; and

a light sensor for detecting light from the light source, the light sensor being located such that a body extremity received in the contractible cuff interposes between the light source and the light sensor, the light sensor being capable of generating the haemodynamic measure indication signal in response to the intensity of light detected from the light source.

3. The pacemaker programming apparatus according to claim 1 wherein the monitoring device comprises one of (i) a pulse oximeter and (ii) a bio-impedance monitor.

4. A pacemaker programming apparatus for use with a pacemaker comprising a monitoring device capable of determining a haemodynamic measure of an individual to each heart beat of the individual and generating a haemodynamic measure signal related to the haemodynamic measure, the pacemaker programming apparatus comprising:

a processor for receiving the haemodynamic measure signal and generating a pacemaker programming signal in response to the haemodynamic measure signal; and

a communication device for sending the pacemaker programming signal to the pacemaker.

5. The pacemaker programming apparatus according to claim 4, wherein the processor generates the pacemaker programming signal by determining a change in the haemodynamic measure, due to adjustment of a setting of an attribute of the pacemaker.

6. A pacemaker programming apparatus comprising:

a processor capable of generating a pacemaker programming signal in response to a haemodynamic measure signal; and

a communication device for sending the pacemaker programming signal to a pacemaker in an individual, wherein the processor generates the pacemaker programming signal by determining a change in the haemodynamic measure due to adjustment of a setting of an attribute of the pacemaker.

7. The pacemaker programming apparatus according to claim 6 wherein the haemodynamic measure signal is indicative of the haemodynamic measure at a first raised heart rate.

8. A pacemaker programming apparatus comprising:

a processor capable of generating a pacemaker programming signal in response to a haemodynamic measure indication signal; and

a communication device for sending the pacemaker programming signal to a pacemaker in an individual, wherein the haemodynamic measure indication signal is indicative of a haemodynamic measure of the individual at a first raised heart rate.

9. The pacemaker programming apparatus according to claim 8 wherein the processor is capable of generating a pacemaker programming signal in response to the haemodynamic measure of the individual at the first raised heart rate and haemodynamic measure of the individual at a second raised heart rate.

10. The pacemaker programming apparatus according to claim 8, further comprising an artefact sensor for detecting the phase of at least one of (i) respiration and (ii) body movements of the individual, the artefact sensor being in communication with the processor.

11. The pacemaker programming apparatus according to claim 10 wherein the artefact sensor comprises a strain gauge.

12. A computer-readable storage medium for storing instructions of a computer program for a pacemaker programming apparatus comprising:

a testing module containing code for receiving a haemodynamic measure indication signal obtained during adjustment of the setting of a first attribute of a pacemaker in an individual;

a determination module containing code for determining from the haemodynamic measure indication signal the change in haemodynamic measure of the individual during adjustment of the setting of the first attribute of the pacemaker; and

a setting selection module containing code for selecting a setting of the first attribute in response to the change in the haemodynamic measure of the individual.

13. The computer-readable storage medium according to claim 12 wherein:

the testing module comprises;

a first module containing code for selecting a setting of the first attribute of the pacemaker;

a second module containing code for receiving a haemodynamic measure indication signal obtained from the individual;

a third module containing code for recording the setting of the first attribute and the respective haemodynamic measure indication signal; and

a fourth module containing code for instructing the first, second and third modules to repeat their activity, a predetermined number of times, at least one different setting of the first attribute, and wherein

the determination module contains code for determining the change in a haemodynamic measure of the individual caused by each setting of the first attribute; and

the setting selection module contains code for selecting the setting of the first attribute in response to its respective change in the haemodynamic measure of the individual.

14. The computer-readable storage medium according to claim 12 further comprising an attribute selection module containing code for selecting the first attribute and instructing the testing module to operate on the selected first attribute.

15. The computer-readable storage medium according to claim 14, wherein the attribute selection module contains code for selecting the first attribute and instructing the testing module, the determination module and the setting selection module to operate on the first attribute and then selecting a second attribute and instructing the testing module, the determination module and the setting selection module to operate on the second attribute.

16. The computer-readable storage medium according to claim 13 wherein:

the first module also contains code for selecting a setting of a second attribute of the pacemaker in the individual;

the third module contains code for recording the combination of the settings of the first and second attributes and the respective haemodynamic measure indication signal;

the fourth module contains code for instructing the first, second and third modules to repeat their activity, a number of times, at least one different setting of at least one of the first and second attribute;

the determination module contains code for determining the change in a haemodynamic measure of the individual caused by each combination of the settings of the first and second attributes; and

the setting selection module contains code for selecting the settings of the first and second attributes in response to their respective changes in the haemodynamic measure of the individual.

17. The computer-readable storage medium according to claim 15, wherein the first attribute is one of the AV delay and the VV delay and the second attribute is the other of the AV delay and the VV delay.

18. The computer-readable storage medium according to claim 12, wherein the first attribute is one of the AV delay and the VV delay.

19. The computer-readable storage medium according to claim 13 wherein the fourth module contains code for instructing the first module to select the same setting of the first attribute at alternate repeats of its activity.

20. The computer-readable storage medium according to claim 13 wherein the fourth module contains code for instructing the first module to select a different setting of the first attribute at each repeat of its activity.

21. The computer-readable storage medium according to claim 13, further comprising a heart beat detection module containing code for receiving a signal indicative of the heart rate of the individual and instructing the first, second and third modules to carry out each repeat of their activity for a length of time equivalent to a number of heart beats of the individual.

22. The computer-readable storage medium according to claim 21, wherein the number of heart beats is 10.

23. A computer-readable storage medium for storing instructions of a computer program for a pacemaker programming apparatus comprising:

a testing module containing code for receiving a haemodynamic measure indication signal obtained during adjustment of the setting of a first attribute of a pacemaker in an individual at raised heart rate; and

a setting selection module containing code for selecting a setting of the first attribute in response to the haemodynamic measure indication signal.

24. The computer-readable storage medium according to claim 23 wherein:

the testing module comprises;

a first module containing code for selecting a setting of the first attribute of the pacemaker;

a second module containing code for receiving a haemodynamic measure indication signal obtained from the individual;

a third module containing code for recording the setting of the first attribute and the respective haemodynamic measure indication signal; and

a fourth module containing code for instructing the first, second and third modules to repeat their activity, a number of times, at least one different setting of the first attribute, and wherein

the setting selection module contains code for selecting the setting of the first attribute in response to its respective haemodynamic measure indication signal.

25. The computer-readable storage medium according to claim 23 further comprising an attribute selection module containing code for selecting the first attribute and instructing the testing module to operate on the selected first attribute.

26. The computer-readable storage medium according to claim 25, wherein the attribute selection module contains code for selecting the first attribute and instructing the testing module and the setting selection module to operate on the first attribute and then selecting a second attribute and instructing the testing module and the setting selection module to operate on the second attribute.

27. The computer-readable storage medium according to claim 24 wherein:

the first module also contains code for selecting a setting of a second attribute of the pacemaker in the individual;

the third module contains code for recording the combination of the settings of the first and second attributes and the respective haemodynamic measure indication signal;

the fourth module contains code for instructing the first, second and third modules to repeat their activity, a number of times, at least one different setting of at least one of the first and second attribute; and

the setting selection module contains code for selecting the settings of the first and second attributes in response to their respective haemodynamic measure indication signals.

28. The computer-readable storage medium according to claim 26, wherein the first attribute is one of the AV delay and the VV delay and the second attribute is the other of the AV delay and the VV delay.

29. The computer-readable storage medium according to claim 23, wherein the first attribute is one of the AV delay and the VV delay.

30. The computer-readable storage medium according to claim 24 wherein the fourth module contains code for instructing the first module to select the same setting of the first attribute at alternate repeats of its activity.

31. The computer-readable storage medium according to claim 24 wherein the fourth module contains code for instructing the first module to select a different setting of the first attribute at each repeat of its activity.

32. The computer-readable storage medium according to claim 24, further comprising a heart beat detection module containing code for receiving a signal indicative of the heart rate of the individual and instructing the first, second and third modules to carry out each repeat of their activity for a length of time equivalent to a number of heart beats of the individual.

33. The computer-readable storage medium according to claim 32, wherein the number of heart beats is 10.

34. The computer-readable storage medium according to claim 23, further comprising a determination module containing code for determining, from the haemodynamic measure indication signal, the change in a haemodynamic measure of the individual during adjustment of the setting of the first attribute of the pacemaker and wherein the setting selection module contains code for selecting a setting of the first attribute in response to the change in the haemodynamic measure of the individual.

35. The computer-readable storage medium according to claim 24

wherein the fourth module contains code for instructing the first, second, and third modules to alternate their activity between two settings of at least one of the first and second attribute.

36. The computer-readable storage medium according to claim 35 wherein the fourth module contains code for instructing the first, second and third modules to alternate their activity between the two settings a predetermined number of times.

37. The computer-readable storage medium according to claim 35 wherein the fourth module contains code for selecting the number of times for alternating the activity of the first, second and third modules between the two settings, in response to comparing the haemodynamic measure of the individual at successive measurements of the or each attribute at the same setting, in response to successive measurements of the or each attribute at the same setting being substantially different and by decreasing the number of times for alternating the activity, in response to successive measurements of the or each attribute at the same setting being substantially similar.

38. The computer-readable storage medium according to claim 24, further comprising a respiratory cycle detection module containing code for receiving a signal indicative of the respiratory cycle of the individual and instructing the first, second and third modules to carry out each repeat of their activity for a length of time related to the detected length of the respiratory cycle.

39. The computer-readable storage medium according to claim 38 wherein the respiratory cycle detection module contains code for instructing the first, second and third modules to carry out each repeat of their activity for the length of time of one complete respiratory cycle of the individual.

40. The computer-readable storage medium according to claim 34 further comprising a heart beat detection module containing code for receiving a signal indicative of the heart rate of the individual and for instructing one or more at least one of the modules such that at least the determination module omits determining the change in the haemodynamic measure for at least the first heart beat of the individual at each setting of at least one of the first and second attribute.

41. The computer-readable storage medium according to claim 24, wherein the setting selection module contains code for selecting the setting of the first attribute or the settings of the first and second attributes by interpolating between the respective changes in the haemodynamic measure of the individual or the blood pressure indication signals at the settings selected by the first module of the testing modules.

42. The computer-readable storage medium according to claim 41 wherein the setting selection module contains code to interpolate by fitting the changes in the haemodynamic measure of the individual or the blood pressure indication signals at the settings selected by the first module of the testing module to a parabola.

43. The computer-readable storage medium according to claim 23 further comprising a programming module containing code for generating a pacemaker programming signal for setting a pacemaker to the setting of the first attribute selected by the setting selection module.

44. (canceled)

45. A method of programming a pacemaker in an individual comprising:

non-invasively determining a haemodynamic measure of an individual as each heart beat of the individual while adjusting the setting of a first attribute of the pacemaker;

selecting a setting of the first attribute of the pacemaker in response to the haemodynamic measure; and

adjusting the attribute of the pacemaker to the selected setting.

46. A method of programming a pacemaker in an individual comprising:

determining the change in a haemodynamic measure of the individual while adjusting the setting of a first attribute of the pacemaker;

selecting a setting of the first attribute of the pacemaker in response to the change in the haemodynamic measure resulting from the setting; and

adjusting the attribute of the pacemaker to the selected setting.

47. A method of programming a pacemaker in an individual comprising:

raising the heart rate of the individual;

determining a haemodynamic measure of the individual while the heart rate is raised and while adjusting a setting of a first attribute of the pacemaker;

selecting a setting of the first attribute of the pacemaker in response to the haemodynamic measure; and

adjusting the attribute of the pacemaker to the selected setting.

48. The method according to claim 47 wherein the step of determining the haemodynamic measure of the individual comprises

constricting a body extremity of the individual;

directing light on the constricted body extremity;

detecting the light passing through the constricted body extremity.

49. The method according to claim 47 wherein the step of determining the haemodynamic measure of the individual comprises use of one of (i) a pulse oximeter and (ii) a bio-impedance monitor.

50. The method according to claim 47 wherein the step of determining the haemodynamic measure of the individual comprises the steps of invasively monitoring a haemodynamic measure of the individual.

51. The method according to claim 47 wherein the step of determining the haemodynamic measure of the individual comprises determining the change in the haemodynamic measure of the individual.

52. The method according to claim 47 wherein the first attribute is one of the AV delay and the VV delay.

53. The method according to claim 47 further comprising the step of subsequently repeating the method with respect to a second attribute of the pacemaker of the individual.

54. The method according to claim 47 wherein the step of determining the haemodynamic measure of the individual is carried out while adjusting the setting of the first attribute and adjusting the setting of a second attribute.

55. The method according to claim 53 wherein the first attribute is one of the AV delay and the VV delay and the second attribute is the other of the AV delay and the VV delay.

56. The method according to claim 47 wherein the step of determining the haemodynamic measure of the individual comprises:

adjusting the first attribute of the pacemaker between more than two settings.

57. The method according to claim 56 wherein the step of determining the haemodynamic measure of the individual comprises alternating the setting of the first attribute between a standard setting and one of a range of test settings.

58. The method according to claim 56 wherein the step of determining the haemodynamic measure of the individual comprises adjusting the setting of the first attribute between a range of test settings.

59. The method according to claim 56, wherein the step of selecting a setting of a first attribute comprises interpolating between the haemodynamic measure that have been determined.

60. The method according to claim 59, wherein the interpolating step is carried out by fitting the haemodynamic measure have been determined to the parabola.

61. The method according to claim 47 wherein the step of determining the haemodynamic measure while adjusting the setting of a first attribute of the pacemaker comprises keeping the first attribute at a particular setting for a number of heart beats while the haemodynamic measure is determined.

62. The method according to claim 61 wherein the number of heart beats is 10.

63. The method according to claim 56 wherein the settings of the first attribute are alternated between two settings as the haemodynamic measure is determined.

64. The method according to claim 63 wherein the settings are alternated are predetermined number of times.

65. The method according to claim 64 wherein the settings are alternated a number of times calculated in response to comparing the haemodynamic measure of the individual at successive measurements at the same setting.

66. The method according to claim 65 wherein the settings are alternated an increased number of times in response to successive measurements at the same setting being substantially different and a decreased number of times in response to successive measurements at the same setting being substantially similar.

67. The method according to claim 47 further comprising the step of monitoring the respiratory cycle of the individual and wherein the determining of the haemodynamic measure of the individual is carried out for a length of time related to the detected length of the respiratory cycle.

68. The method according to claim 67 wherein the step of determining the haemodynamic measure of the individual is carried out for the length of time of complete respiratory cycle of the individual.

69. The method according to claim 47 further comprising the step of monitoring the heart beat of the individual and wherein the step of determining the haemodynamic measure of the individual is carried out omitting results from at least the first heart beat of the individual after the setting of at least one of the first and second attribute of the pacemaker.

70. The method according to claim 47 further comprising the steps of monitoring the phase of at least one of respiration and body movements of the individual and accounting for the effects of the phase of at least one of respiration and any body movements of the individual in the determination of the haemodynamic measure.

71. The method according to claim 47 wherein the haemodynamic measure is one of the following:

(i) the blood pressure of the individual;

(ii) the absolute value of the blood pressure of the individual at one point in time or at a plurality of points in time;

(iii) the change in blood pressure of the individual over a period of time;

(iv) the stroke volume of the individual; and

(v) the cardiac output of the individual.

72. The method according to claim 71, wherein the blood pressure of the individual is one of a systolic pressure, diastolic pressure, mean pressure, pulse pressure, rate of change of pressure, and peak rate of change of pressure.

73. The method according to claim 47 wherein the pacemaker is a biventricular pacemaker.