Pacemaker with patient effort-controlled frequency

• US 5,330,510 A
• Filed: 12/22/1992
• Issued: 07/19/1994
• Est. Priority Date: 12/31/1991
• Status: Expired due to Term

• Current Assignee: Ela Medical S.A. (LivaNova Plc)
• Original Assignee: Ela Medical S.A. (LivaNova Plc)
• Inventors: Ripart, Alain, Legay, Thierry
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US07/995,050
• Time in Patent Office: 574 Days
• Field of Search: 607/18, 607/19
• US Class Current: 607/19
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration

Abstract

A pacemaker with patient effort-controlled stimulation frequency that responds to a control parameter. Accelerometers (1) with capacity variation are placed on a substratum. Each of the accelerometers is sensitive in one direction of a Cartesian coordinate system. The output of the accelerometers are combined and integrated over a small time constant to produce a signal representative of the patient'"'"'s metabolic power exerted. The signal is then used to control the stimulation frequency of the pacemaker. The integration may be based on the sum of the absolute value of the acceleration signals or the square root of the sum of the squares of the acceleration signals.

Claims

1. A pacemaker having a stimulation frequency controlled by the patient'"'"'s effort according to a control parameter computer from the acceleration measured at the level of the patient'"'"'s trunk, comprising first means for measuring acceleration along a first axis, second means for measuring acceleration along a second axis, and third means for measuring acceleration along a third axis, wherein the third axis is perpendicular to said first and second axes, and said first and second axes are perpendicular to one another and parallel to said flat surface, and wherein said first, second and third measuring means operate independently of one another;

and

means for determining said control parameter for controlling the stimulation frequency as a function of the measured acceleration in said first, second and third axes.

2. The pacemaker as claimed in claim 1, wherein first, second and third measuring means further comprise first, second and third output signals corresponding to acceleration in the first, second and third axes respectively, and said determining means further comprise means for determining the control parameter as the integral, computed for a period of time, of the sum of the absolute values of said first, second and third signals.

3. The pacemaker as claimed in claim 2, wherein said determining means further comprises an integrator which generates a fast ramp signal with a time constant of a few milliseconds in response to said sum, a reference voltage comparator having an input for the ramp signal and an input for a reference signal, a first output state when the ramp is less than the reference signal and a second state when the ramp signal reaches the reference signal, wherein the comparator flips states in response to the ramp signal reaching the reference signal, a monostable circuit issuing a pulse at each flip of said comparator, and a counter for counting the number of pulses issued, wherein the count is said control parameter issuing an output signal in digital form.

4. The pacemaker as claimed in claim 1, wherein first, second and third measuring means further comprise first, second and third output signals corresponding to acceleration in the first, second and third axes respectively, and said determining means further comprises means for determining the control parameter as the integral, computed for a period of time, of the square root of the sum of the squares of said first, second and third signals representing the acceleration along said axes.

5. The pacemaker as claimed in claim 1, wherein the first, second and third acceleration measuring means are each comprised of an accelerometer that has a capacitance that varies in response to acceleration and an output signal that corresponds to said capacitance, wherein said accelerometer is sensitive to acceleration in one direction.

6. The pacemaker as claimed in claim 5, wherein two of said first, second and third measuring means are mounted on a same substratum and oriented so that their one directions of sensitivity are perpendicular.

7. The pacemaker as claimed in claim 6, wherein said other of the first, second and third measuring means has its one direction of sensitivity in a direction perpendicular to the plane of said substratum.

8. The pacemaker as claimed in claim 7, wherein said third measuring means is mounted in the plane of said substratum.

9. The pacemaker as claimed in claim 7, wherein said third measuring means is mounted on said substratum.

10. A method of providing a control parameter for a pacemaker having a stimulation frequency controlled by the patient'"'"'s effort, comprising:

measuring first and second signals corresponding respectively to the acceleration, in response to patient effort, at the level of the patient'"'"'s trunk along two axes perpendicular to one another;

measuring a third signal corresponding to the acceleration, in response to patient effort, at the level of the patient'"'"'s trunk along a third axis perpendicular to said first, second and third signals are measured independently of one another;

computing a control parameter as a function of said first, second and third signals; and

providing said control parameter for controlling the pacemaker stimulation frequency;

11. The method of claim 15 wherein computing said control parameter further comprises processing the values of the first, second and third signals in relation to the metabolic power used up by the patient in the course of the effort producing said first, second and third signals.

12. The method of claim 11, wherein computing the control parameter further comprising obtaining the absolute values of said first, second, and third signals, summing said absolute values, and integrating said sum for a time period, said integrated sum at end of the time period being the control pacemaker.

13. The method of claim 11 wherein computing said control parameter further comprises squaring the value of each of the first, second and third signals, summing said square values, taking the square root of said sum, and integrating said square root for a time period, said integrated sum at the end of the time period being the control parameter.

14. The method of claim 10 wherein measuring each of the first second and third signals further comprises providing first, second and third accelerometers each of which is sensitive to motion in one direction and has an output signal corresponding to motion in said one direction, and orienting the first and second accelerometers along said two axes and orienting the third accelerometer along the third axis so that the first, second and third accelerometer outputs provide the first, second and third signals, respectively.

15. The method of claim 14 wherein providing the first, second an third accelerometer further comprises providing each said accelerometer with a capacity variation output that changes in response to acceleration.

16. The method of claim 14 wherein providing each of the first, second and third accelerometer further comprises providing an accelerometer made of a flat substratum, such that the one direction of sensitivity is contained in the plane of said substratum.

17. The method of claim 16 wherein providing the first, second and third accelerometer further comprises providing two of the first, second and third accelerometers mounted on or in the same substratum and oriented so as to be sensitive in perpendicular directions in said same substration plane.

18. The method of claim 17 further comprising mounting said other of the first, second and third accelerometers in the plane of said substratum.

19. A pacemaker with a stimulation frequency controlled by a control parameter related to the patient'"'"'s effort, comprising:

a pacemaker box having a flat surface for implanting in a vertical orientation in a patient;

first means for measuring a first signal corresponding to the acceleration due to patient effort along a first axis;

second means for measuring a second signal corresponding to the acceleration due to patient effort along a second axis, wherein the first and second axes are perpendicular to one another and parallel to said flat surface of the pacemaker box; and

means for computing a control parameter for controlling the parameter stimulation frequency based on the first and second signals.

20. The apparatus of claim 19 wherein the computing means further comprises means for providing a third signal as a function of the first and second signals and means for integrating the third signal over a time period wherein the integrating means is highly constant in time and provides a digital output signal as the control parameter.

21. The apparatus of claim 20 wherein said integrating means comprises an integrator which generates a fast ramp signal in response to the third signal with a time constant of a few milliseconds, a reference voltage comparator having an input for a reference voltage and an input for the ramp signal input and an output that flips state in response to the ramp signal input reaching or exceeding the reference voltage, a monostable circuit having a pulse output in response to each flip of said comparator, and a counter for counting each pulse output during said time period, wherein the counter count provides the digital output signal.

22. The apparatus of claim 20 wherein said providing means further comprises means for providing the third signal as the sum of the absolute values of said first and second signals.

23. The apparatus of claim 20 wherein said providing means further comprises means for providing the third signal as the square root of the sum of the squares of said first and second signals.

24. The apparatus of claim 19 wherein the first and second measuring means further comprise a first accelerometric sensor having a capacitance that varies in response to motion along the first axis and a second accelerometric sensor having a capacitance that varies in response to motion along the second axis.

25. A method for providing a control parameter related to the effort of a patient for a pacemaker having a stimulation frequency controlled by the patient'"'"'s effort, comprising:

providing a pacemaker box with a flat surface for implantation in a patient so that said flat surface is disposed in a vertical orientation;

measuring first and second signals corresponding to the acceleration, in response to patient effort, along first and second axes which are perpendicular to one another and parallel to said flat surface of the pacemaker box;

computing a control parameter based on the first and second signals; and

providing said control parameter for controlling the pacemaker stimulation frequency.

26. The method of claim 25 wherein computing said control parameter further comprises computing said control parameter as a function of the values of the signals representing the acceleration along said first and second axes, in relation to the metabolic power used up by the patient in the course of the effort producing said first and second signals.

27. The method of claim 26 wherein computing said control parameter function further comprises processing the first and second signals to produce a third signal, integrating the third signal over a time period, and providing the integrated third signal at the end of the time period in the form of a digital output signal as the control parameter.

28. The method of claim 27 wherein integrating the third signal further comprises generating a fast ramp signal in response to the third signal with a time constant of a few milliseconds, providing a reference voltage, comparing the ramp signal to the reference voltage, issuing a pulse each time the ramp signal reaches or exceeds the reference voltage, and counting each pulse during said time period, wherein the count provides the digital output signal.

29. The method of claim 27 wherein processing the first and second signals further comprises providing the sum of the absolute values of said first and second signals.

30. The method of claim 27 wherein processing the first and second signals further comprises providing the square root of the sum of the squares of said first and second signals.

31. The method of claim 25 wherein measuring said first and second signals further comprises sensing separately a capacity variation in response to acceleration in each axis.

32. A pacemaker having a frequency controlled by a patient'"'"'s effort comprising:

a first accelerometer having a first signal corresponding to acceleration along a first axis;

a second accelerometer having a second signal corresponding to acceleration along a second axis;

a third accelerometer having a third signal corresponding to acceleration along a third axis, the first, second, and third axes being orthogonal;

means for computing a control parameter, representative of the patient'"'"'s effort for varying the pacemaker frequency, as a function of the first, second, and third signals, said computing means further comprising means for summing the absolute values of the first, second, and third signals and means for integrating said sum over a time period and producing an output signals that is said integrated sum at the end of said time period, wherein the output signal represents said control parameter.

33. The pacemaker of claim 32 wherein said integrating means output signal is said control parameter in digital form.

34. The pacemaker of claim 32 wherein said integrating means further comprises:

a generator having a ramp signal output and a time constant, the time constant being less than the time period;

means for comparing the ramp generator output to a reference threshold and flipping states when the ramp generator output rises to the reference threshold;

a monostable circuit connected to the comparator output, said monostable circuit generating a pulse in response to a flip of the comparator means; and

a counter that response to a pulse generated by the monostable circuit, wherein the counter counts the number of pulses generated during the time period, said count output at the end of the time period being the control parameter in digital form.

35. The pacemaker of claim 34 further comprising a processing means for receiving said output count at the end of the time period and determining the pacing frequency as a function of said count.

36. A pacemaker having a stimulation frequency controlled by a control parameter related to the patient'"'"'s effort comprising:

a first accelerometer that is sensitive to motion in one direction having a first signal output corresponding to acceleration along a first axis;

a second accelerometer that is sensitive to motion in one direction having a second signal output corresponding to acceleration along a second axis, the first and second axes being perpendicular;

wherein the first and second accelerometers are each comprised of a flat substratum disposed in a plane such that the one direction of sensitivity is contained in said substratum plane; and

means for computing a control parameter, representative of the patient'"'"'s effort for varying the pacemaker frequency, as a function of the first and second signals.

37. The pacemaker of claim 36 wherein each of the first and second accelerometers has a capacitance that varies in response to motion in said one direction.

38. The pacemaker of claim 36 wherein in the first and second accelerometers further comprise the same substratum such that the one directions of the two accelerometers are perpendicular and contained in said same substratum plane.

39. The pacemaker of claim 38 wherein each of the first and second accelerometers has a capacitance that varies in response to motion in said one direction.

40. The pacemaker of claim 36 wherein the computing means further comprises means for summing the absolute values of the first and second signals, and means for integrating said sum over a time period and producing an output signal that is said integrated sum at the end of said time period, wherein the output signal is said control parameter.

41. The pacemaker of claim 40 wherein each of the first and second accelerometers has a capacitance that varies in response to motion in said one direction.

42. The pacemaker of claim 40 wherein said integrating means further comprises:

a generator having an input for said sum signal, a ramp signal output and a time constant, the time constant being less than the time period;

means for comparing the ramp generator output to a reference threshold and flipping states when the ramp generator output rises to the reference threshold;

a monostable circuit connected to the comparator output, said monostable circuit generating a pulse in response to a flip of the comparator means; and

a counter that responds to a pulse generated by the monostable circuit, wherein the counter counts the number of pulses generated during the time period, said count output at the end of the time period being the control parameter in digital form.

43. The pacemaker of claim 36 wherein the computing means further comprises means of taking the square root of the sum of the squares of the first and second signals, and means for integrating said square root over a time period and producing an output signal that is said integrated square root at the end of said time period, wherein the output signal is said control parameter.

44. The pacemaker of claim 43 wherein each of the first and second accelerometers has a capacitance that varies in response to motion in said one direction.

45. The pacemaker of claim 36 further comprising:

a third accelerometer that is sensitive to motion in one direction having a third signal output corresponding to acceleration along a third axis, the third axis being perpendicular to the first and second axes;

wherein the third accelerometer is comprised of a flat substratum disposed in a plane such that the one direction of sensitivity is contained in said substratum plane; and

wherein said computing means computes said control parameter as a function of the first, second and third signals.

46. The pacemaker of claim 45 wherein each of the first, second and third accelerometers has a capacitance that varies in response to motion in said one direction.

47. The pacemaker of claim 45 wherein two of the first, second and third accelerometers further comprise the same substratum such that the one directions of the said two accelerometers are perpendicular and contained in said same substratum plane.

48. The pacemaker of claim 46 wherein each of the first, second and third accelerometers has a capacitance that varies in response to motion in said one direction.

49. The pacemaker of claim 45 wherein the computing means further comprises means or summing the absolute values of the first, second and third signals and means for integrating said sum over a time period and producing an output signal that is said integrated sum at the end of said time period, wherein the output signal represents said control parameter.

50. The pacemaker of claim 45 wherein the computing means further comprises means for taking the square root of the sum of the squares of the first, second, and third signals, and means for integrating said square root over a time period and producing an output signal that is said integrated square root at the end of said time period, wherein the output signal represents said control parameter.

51. A method for calculating a control parameter related to a patient'"'"'s effort for use in controlling the stimulation frequency of a pacemaker comprising:

a) measuring first and second signals corresponding to the acceleration along first and second axes which are perpendicular to one another;

b) providing the sum of the absolute values of the first and second signals as a third signal; and

c) integrating the third signal over a time period and providing said integrated third signal as the control parameter, wherein the control parameter is used to control the stimulation frequency of a pacemaker.

52. The method of claim 51 wherein step c) further comprises providing said integrated third signal in digital form.

53. The method of claim 51 wherein step c) further comprises:

providing a time constant and a reference threshold, the time constant being less than the time period;

generating a ramp signal output in response to said third signal and said time constant;

comparing the ramp signal output to the reference threshold;

indicating when the ramp signal output rises to the threshold and resetting the ramp signal output;

counting the number of times the ramp signal output rises to the threshold during the time period, wherein said count output at the end of the time period represents the control parameter in digital form.

54. The method of claim 53 comprising processing the count output at the end of the time period and determining the pacing frequency as a function of said count.

55. A method for calculating a control parameter related to a patient'"'"'s effort for use in controlling the stimulation frequency of a pacemaker, comprising:

a) providing first and second accelerometric sensors, each being comprised of a flat substratum and sensitive in one direction contained in the plane of said substratum, wherein the one direction of the first accelerometric sensor and the one direction of the second accelerometric sensor are perpendicular;

b) sensing the output of the first and second accelerometric sensors as first and second signals;

c) processing the first and second signals to form a third signal as a function of the first and second signals, said function being related to the patient'"'"'s effort producing the first and second signals; and

d) integrating the third signal over a time period and providing said integrated third signal as a control parameter, wherein the control parameter is used to control the stimulation frequency of a pacemaker.

56. The method of claim 55 wherein step a) further comprises providing each of the first and second accelerometers with a capacity variation in response to motion in said one direction.

57. The method of claim 55 wherein step a) further comprises forming the first and second accelerometers in the same substratum such that the one directions of the two accelerometers are perpendicular and contained in said same substratum plane.

58. The method of claim 57 wherein step a) further comprises providing each of the first and second accelerometers with a capacity variation in response to motion in said one direction.

59. The method of claim 55 wherein step c) further comprises summing the absolute values of the first and second signals, and wherein step d) further comprises integrating said sum over the time period to produce said control parameter.

60. The method of claim 59 wherein step a) further comprises:

providing each of the first and second accelerometers with a capacity variation in response to motion in said one direction; and

forming the first and second accelerometers in the same substratum such that the one directions of the two accelerometers are perpendicular and contained in said same substratum plane.

61. The method of claim 59 wherein step d) further comprises:

providing a time constant and a reference threshold, the time constant being less than the time period;

generating a ramp signal output in response to said sum and said time constant;

comparing the ramp signal output to the reference threshold;

indicating when the ramp signal output rises to the reference threshold and resetting the ramp signal output;

counting the number of times the ramp signal output rises to the reference threshold during the time period, wherein said count output at the end of the time period is the control parameter in digital form.

62. The method of claim 55 wherein step c) further comprises taking the square root of the sum of the squares of the first and second signals, and wherein step d) integrates said square root over said time period to produce said control parameter.

63. The method of claim 62 wherein step a) further comprises:

providing each of the first and second accelerometers with a capacity variation in response to motion in said one direction; and

forming the first and second accelerometers in the same substratum such that the one directions of the two accelerometers are perpendicular and contained in said same substratum plane.

64. The method of claim 63 wherein step d) further comprises:

providing a time constant and a reference threshold, the time constant being less than the time period;

generating a ramp signal output in response to said sum;

comparing the ramp signal output to the reference threshold;

indicating when the ramp signal output rises to the reference threshold and resetting the ramp signal output;

counting the number of times the ramp signal output rises to the reference threshold during the time period, wherein said count output at the end of the time period is the control parameter in digital form.

65. The method of claim 55, further comprising:

providing a third accelerometric sensor comprised of a flat substratum and sensitive in one direction contained in the plane of said substratum;

orienting the one direction of the third accelerometric sensor perpendicular to the one directions of the first and second accelerometric sensors;

sensing the output of the third accelerometric sensor as a fourth signal; and

wherein step c) further comprises processing the first, second and fourth signals to form said third signal as a function of the first, second and fourth signals.

66. The method of claim 65 wherein step a) further comprises providing each of the first, second and third accelerometers with a capacity variation in response to motion in said one direction.

67. The method of claim 65 wherein step a) further comprises forming two of the first, second and third accelerometers in the same substratum such that the one directions of the two accelerometers are perpendicular and contained in said same substratum plane.

68. The method of claim 67 wherein step a) further comprises providing each of the first, second and third accelerometers with a capacity variation in response to motion in said one direction.

69. The method of claim 65 wherein step c) further comprises summing the absolute values of the first, second and fourth signals and wherein step d) further comprises integrating said sum over said time period.

70. The method of claim 65 wherein step c) further comprises taking the square root of the sum of the squares of the first, second, and fourth signals, and wherein step d) further comprises integrating said square root over said time period.