Posture and device orientation and calibration for implantable medical devices

• US 6,044,297 A
• Filed: 09/25/1998
• Issued: 03/28/2000
• Est. Priority Date: 09/25/1998
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sheldon, Todd J., Combs, William J., Erickson, Mark K., Cinbis, Can
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/160,647
• Time in Patent Office: 550 Days
• Field of Search: 607/17-19, 600/587, 600/595
• US Class Current: 607/17
• CPC Class Codes: A61N 1/36535 controlled by body position or posture
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration

Abstract

A method of and apparatus for determining the physical posture of a patient'"'"'s body, having a superior-inferior body axis, an anterior-posterior body axis and a lateral-medial body axis, in relation to earth'"'"'s gravitational field. A medical device having first, second and, optionally, third accelerometers having sensitive axes mounted orthogonally within an implantable housing is adapted to be implanted with the sensitive axes nominally aligned with ideal X, Y and Z device axes correlated to patient body axes. Each accelerometer generates DC accelerometer signals having characteristic magnitudes and polarities on alignment of the sensitive axis with, against or normal to earth'"'"'s gravitational field and DC accelerometer signals of varying magnitudes and polarities when not so aligned. The actual pitch and roll angles of the sensitive axes of the accelerometers in the implanted IMD with respect to the true gravitational axes are determined and the yaw angles are determined or estimated. Corrected DC accelerometer output signals are derived from the pitch, roll and yaw angles and are compared to a set of stored thresholds for each body posture to determine the actual body posture. Storage of these comparisons or the raw signals themselves can be used for histogram data to provide theraputic or research benefits also described.

Claims

1. A method of determining the physical posture of a patient'"'"'s body, having an ideal Y axis, aligned with the superior-inferior body axis, an ideal Z axis aligned with the anterior-posterior body axis, and an ideal X axis aligned with the lateral-medial body said axis in relation to earth'"'"'s gravitational field comprising the steps of:

implanting a multi-axis, solid state sensor in the patient'"'"'s body, said solid state sensor comprising X, Y, and Z accelerometers having X, Y, and Z device axes, respectively, orthogonally disposed to one another, which provide X, Y, and Z accelerometer output signals, respectively, of a magnitude and polarity dependent on the degree of alignment of the respective axis with earth'"'"'s gravitational field;

in a calibration mode following implantation;

measuring a first set of accelerometer output signals from said X, Y, and Z accelerometers while the patient is in a first body posture;

measuring a second set of accelerometer output signals from said X, Y, and Z accelerometers while the patient is in a second body posture orthogonal to said first body posture;

from said first and second sets of accelerometer output signals, deriving a pitch angle of the Y and Z device axes from the Y ideal axis and the Z ideal axis, respectively, due to rotation of the Y and Z device axes about the X device axis;

from said X and Z sets of accelerometer output signals, deriving a yaw angle of the X and Z device axes from the X ideal axis and the Z ideal axis, respectively, due to rotation of the X and Z device axes about the Y device axis; and

from said X and Y sets of accelerometer output signals, deriving a roll angle of the X and Y device axes from the X ideal axis and the Y ideal axis, respectively, due to rotation of the X and Y device axes about the Z device axis; and

in a normal operating mode, determining an unknown body posture of the patient by;

measuring the X, Y, and Z accelerometer output signals while the patient is in the unknown body posture;

correcting the measured X, Y, and Z accelerometer output signals employing the derived pitch, roll and yaw angles to derive corrected X, Y, and Z accelerometer output signals; and

determining the body posture of the patient employing the corrected X, Y, and Z accelerometer output signals.

2. The method of claim 1, further comprising the step of:

defining a set of X, Y, and Z thresholds for body postures that the patient can assume with respect to earth'"'"'s gravitational field; and

wherein the body posture determining step further comprises the steps of;

comparing the magnitudes and polarities of the corrected X, Y, and Z accelerometer output signals with the X, Y, and Z respective thresholds of each set of thresholds; and

determining the body posture of the patient most closely corresponding to the set of thresholds that is met by the X, Y, and Z corrected accelerometer output signals.

3. The method of claim 2, wherein the defining step further comprises the step of defining the sets of thresholds in relation to characteristic magnitudes and polarities of the accelerometer output signals on alignment of the device axes of the X, Y, and Z accelerometers with or normal to earth'"'"'s gravitational field in each body posture.

4. The method of claim 2, wherein the defining step further comprises the step of defining the sets of thresholds in relation to characteristic magnitudes and polarities of the accelerometer output signals on alignment of the device axes of the X, Y, and Z accelerometers with or normal to earth'"'"'s gravitational field in each body posture, including the upright body posture while standing or walking or running, a sitting body posture, a supine body posture, a prone body posture and left and right side lying body postures.

5. The method of any of the claims 1-4, further comprising the step of storing said determined body posture of the patient.

6. The method of any of the claims 1-4, further comprising the step of delivering a treatment therapy to the patient having a treatment parameter dependent on the determined body posture.

7. The method of any of the claims 1-4, further comprising the steps of:

storing said determined body posture of the patient; and

delivering a treatment therapy to the patient having a treatment parameter dependent on the determined body posture.

8. The method of any of the claims 1-4, further comprising the steps of:

defining a characteristic activity magnitude of at least one of the first, second and third accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying a threshold patient activity level; and

deriving an activity level signal from said at least one of the X, Y or Z accelerometer signals exceeding said characteristic activity magnitude over a predetermined time period.

9. The method of any of the claims 1-4, further comprising the steps of:

defining a characteristic activity magnitude of at least one of the X, Y, and Z accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying a threshold patient activity level;

deriving an activity level signal from said at least one of the X, Y, or Z accelerometer signals exceeding said characteristic activity magnitude over a predetermined time period; and

delivering a treatment therapy to the patient having a treatment parameter dependent on the determined body posture and the activity level signal of the patient.

10. The method of any of the claims 1-4, further comprising the steps of:

defining a characteristic activity magnitude of at least one of the X, Y and Z accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying a threshold patient activity level;

deriving an activity level signal from said at least one of the X, Y or Z accelerometer signals exceeding said characteristic activity magnitude over a predetermined time period; and

storing said determined body posture and activity level of the patient.

11. The method of any of the claims 1-4 wherein the device'"'"'s ideal axes are nominally defined as having orthogonal axes comprising a ideal Y-axis aligned with the superior-inferior body axis and aligned with earth'"'"'s gravitational field, so as to measure 1 g of acceleration when the patient is in an upright body posture, a ideal X-axis normal to the ideal Y-axis aligned with the lateral-medial body axis and orthogonal to the earth'"'"'s gravitational field, so as to measure 0 g of acceleration when the patient is in an upright body posture, and an ideal Z-axis normal to the ideal X-axis and the ideal Y-axis and aligned to the anterior-posterior body axis and orthogonal to the earth'"'"'s gravitational field, so as to measure 0 g of acceleration when the patient is in an upright body posture, and wherein:

said implanting step further comprises implanting said multi-axis, solid state sensor in the patient'"'"'s body so that the X device axis is nominally aligned with the lateral-medial body axis, the Y device axis is nominally aligned with the superior-inferior body axis, and the Z device axis is nominally aligned with the anterior-posterior body axis;

said step of measuring a first set of accelerometer output signals from said X, Y, and Z, and accelerometers is performed while the patient is in a first body posture wherein the ideal Y axis is nominally in alignment with the earth'"'"'s gravitational field and ideal X and Z axes are nominally normal to the ideal Y-axis; and

said step of measuring a second set of accelerometer output signals from said X, Y, and Z accelerometers is performed while the patient is in a second body posture orthogonal to said first body posture wherein one of the X or Z ideal axes is nominally in alignment with the earth'"'"'s gravitational field and the other of the X or Z ideal axes and the Y ideal axis are nominally normal to the earth'"'"'s gravitational field.

12. The method of any of the preceding claims 1-4, wherein the first body posture is the upright standing body posture and the second body posture is a selected one of the supine body posture, prone body posture, left side lying body posture, and right side lying body posture.

58. A method as set forth in any of claims 1-4 or 13-16 or 53-55 further comprising the step of storing posture related data over time.

59. A method as set forth in any of claims 1-4 or 13-16 or 53-55 further comprising the step of storing device orientation relative to ideal axes over time.

13. A method of determining the physical posture of a patient'"'"'s body, having a superior-inferior body axis or ideal Y axis, an anterior-posterior body axis or ideal Z axis and a lateral-medial body axis or ideal X axis, in relation to earth'"'"'s gravitational field comprising the steps of:

implanting a multi-axis, solid state sensor in the patient'"'"'s body, said solid state sensor comprising X, Y and Z DC accelerometers having X, Y and Z device axes, respectively, orthogonally disposed to one another, which provide X, Y and Z DC accelerometer output signals, respectively, of a magnitude and polarity dependent on the degree of alignment of the respective device axis with earth'"'"'s gravitational field;

in a calibration mode following implantation;

determining that the patient is in an upright body posture wherein said ideal Y axis is nominally into alignment with earth'"'"'s gravitational field and X and Z ideal axes are nominally normal to earth'"'"'s gravitational field;

setting a yaw angle of the X and Z device axes from the ideal X or lateral-medial body axis and the ideal Z or anterior-posterior body axis, respectively, at a fixed value based on the assumption of minimal rotation of the X and Z device axes about the Y device axes after implantation;

measuring at least one set of DC accelerometer output signals from the X, Y, and Z DC accelerometers in the assumed upright body posture;

deriving a pitch angle of the Y and Z device axes from the ideal Y axis and the ideal Z axis, respectively, due to rotation of the Y and Z device axes a about the X device axis from the measured set of DC accelerometer output signals; and

deriving a roll angle of the X and Y device axes from the ideal X axis and the ideal Y axis, respectively, due to rotation of the X and Y device axes about the device Z axis from the measured set of DC accelerometer output signals; and

in a normal operating mode, determining an unknown posture of the patient by;

measuring the X, Y, and Z DC accelerometer output signals;

correcting the measured X, Y, and Z DC accelerometer output signals

employing the stored pitch, roll and yaw angles to derive corrected X, Y, and Z DC accelerometer output signals; and

determining the body posture of the patient employing the corrected X, Y, and Z DC accelerometer output signals.

14. The method of claim 13, further comprising the step of:

defining a set of X, Y, and Z thresholds for each body posture that the patient can assume with respect to the orthogonal ideal axes; and

wherein the body posture determining step further comprises the steps of;

comparing the magnitudes and polarities of the corrected X, Y, and Z DC accelerometer output signals with the X, Y, and Z respective thresholds of each set of thresholds; and

determining the body posture of the patient corresponding to the set of thresholds that is met by the X, Y, and Z corrected DC accelerometer output signals.

15. The method of claim 14, wherein the defining step further comprises the step of defining the sets of thresholds in relation to characteristic magnitudes and polarities of the DC accelerometer output signals on alignment of the X, Y, and Z DC accelerometers with or normal to earth'"'"'s gravitational field in each body posture.

16. The method of claim 14, wherein the defining step further comprises the step of defining the sets of thresholds in relation to characteristic magnitudes and polarities of the DC accelerometer output signals on alignment of the sensitive axes of the X, Y, and Z DC accelerometers with or normal to earth'"'"'s gravitational field in each body posture, including the upright body posture while standing or walking or running, a sitting body posture, a supine body posture, a prone body posture and left and right side lying body postures.

17. The method of any of the claims 13-16, further comprising the step of storing said determined body posture of the patient.

18. The method of any of the claims 13-16, further comprising the step of delivering a treatment therapy to the patient having a treatment parameter dependent on the determined body posture.

19. The method of any of the claims 13-16, further comprising the steps of:

storing said determined body posture of the patient; and

delivering a treatment therapy to the patient having a treatment parameter dependent on the determined body posture.

20. The method of any of the claims 13-16, wherein the step of determining that the patient is in an upright body posture further comprises the steps of:

defining a characteristic activity magnitude of at least one of the first, second and third DC accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying a threshold patient activity level; and

deriving an activity level signal from said at least one of the first, second or third DC accelerometer signals exceeding said characteristic activity magnitude over a predetermined time period that is characteristic of the patient walking in an upright body posture.

21. The method of any of the claims 13-16, wherein:

the step of determining that the patient is in an upright body posture further comprises the steps of;

defining a characteristic activity magnitude of at least one of the X, Y, and Z DC accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying that the patient is walking in an upright body posture; and

determining that the patient is walking when the current magnitude of at least one of the X, Y, and Z DC accelerometer output signals matches or exceeds the characteristic activity magnitude over a predetermined time period that is characteristic of the patient walking in an upright body posture; and

the step of measuring at least one set of DC accelerometer output signals from the X, Y, and Z DC accelerometers in the assumed upright body posture further comprises;

measuring a plurality of sets of DC accelerometer output signals from the X, Y, and Z DC accelerometers in the assumed upright body posture; and

averaging each set of measured DC accelerometer output signals from the X, Y, and Z DC accelerometers to derive an averaged set of DC accelerometer output signals.

22. The method of any of the claims 13-16, wherein:

the step of determining that the patient is in an upright body posture further comprises the steps of;

defining a characteristic activity magnitude of at least one of the X, Y, and Z DC accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying that the patient is walking in an upright body posture; and

determining that the patient is walking when the current magnitude of at least one of the X, Y, and Z DC accelerometer output signals matches or exceeds the characteristic activity magnitude over a predetermined time period that is characteristic of the patient walking in an upright body posture;

the step of measuring a set of DC accelerometer output signals from the X, Y, and Z DC accelerometers in the assumed upright body posture further comprises;

measuring a plurality of sets of DC accelerometer output signals from the X, Y, and Z DC accelerometers in the assumed upright body posture; and

averaging each set of measured DC accelerometer output signals from the X, Y, and Z DC accelerometers to derive an averaged set of DC accelerometer output signals; and

the steps of deriving pitch angle and roll angle further comprise;

periodically deriving a pitch angle of the Y and Z device axes from the Y and Z ideal axis, respectively, due to rotation of the Y and Z device axes about the X device axis from the measured and averaged set of DC accelerometer output signals; and

periodically deriving a roll angle of the X and Y device axes from the X and Y ideal axes, respectively, due to rotation of the X and Y device axes about the Z device axis from the measured and averaged set of DC accelerometer output signals.

23. The method of any of the claims 13-16, further comprising the steps of:

defining a characteristic activity magnitude of at least one of the X, Y, and Z DC accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying a threshold patient activity level; and

deriving an activity level signal from said at least one of the X, Y and Z DC accelerometer signals exceeding said characteristic activity magnitude over a predetermined time period.

24. The method of any of the claims 13-16, further comprising the steps of:

defining a characteristic activity magnitude of at least one of the X, Y and Z DC accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying a threshold patient activity level;

deriving an activity level signal from said at least one of the X, Y and Z DC accelerometer signals exceeding said characteristic activity magnitude over a predetermined time period; and

delivering a treatment therapy to the patient having a treatment parameter dependent on the determined body posture and the activity level signal of the patient.

25. The method of any of the claims 13-16, further comprising the steps of:

defining a characteristic activity magnitude of at least one of the first, X, Y and Z DC accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying a threshold patient activity level;

deriving an activity level signal from said at least one of the X, Y and Z DC accelerometer signals exceeding said characteristic activity magnitude over a predetermined time period; and

storing said determined body posture and activity level of the patient.

26. The method of any of an claims 13-16 wherein the ideal coordinate system is nominally defined as having ideal axes comprising a ideal Y-axis aligned to earth'"'"'s gravitational field, nominally aligned with the superior-inferior body axis, so as to measure 1 g of acceleration when the patient is in an upright body posture, an ideal X-axis normal to the ideal Y-axis and nominally aligned with the lateral-medial body axis, so as to measure 0 g of acceleration when the patient is in an upright body posture, and an ideal Z-axis normal to the ideal X-axis and the ideal Y-axis and nominally aligned to the anterior-posterior body axis, so as to measure 0 g of acceleration when the patient is in an upright body posture, and wherein:

said implanting step further comprises implanting said multi-axis, solid state sensor in the patient'"'"'s body so that the X device axis is nominally aligned with the lateral-medial body axis, the Y device sensitive axis is nominally aligned with the superior-inferior body axis, and the Z device axis is nominally aligned with the anterior-posterior body axis; and

said step of measuring a set of DC accelerometer output signals from said X, Y and Z DC accelerometers is performed while the patient is in an assumed upright body posture such that the Y device axis is nominally in alignment with the earth'"'"'s gravitational field and the X and Z device axes are nominally normal to the earth'"'"'s gravitational field.

27. In an implantable medical device, a system for determining the body posture of a patient'"'"'s body having an ideal Y axis aligned with the superior-inferior body axis, an ideal Z axis aligned with the anterior-posterior body axis and an ideal X axis aligned with lateral-medial body axis, in relation to earth'"'"'s gravitational field comprising:

a multi-axis, solid state sensor, comprising X, Y and Z DC accelerometers having X, Y and Z device axes, respectively, orthogonally disposed to one another, which provide X, Y and Z DC accelerometer output signals, respectively, of a magnitude and polarity dependent on the degree of alignment of the respective device axis with earth'"'"'s gravitational field, the multi-axis, solid state sensor associated with the implantable medical device and adapted to be implanted in the patient'"'"'s body so that the X device axis is nominally aligned with the lateral-medial body axis, the Y device axis is nominally aligned with the superior-inferior body axis, and the Z device axis is nominally aligned with the anterior-posterior body axis;

means for correcting for deviations in alignment of the X device axis from the ideal X axis or lateral-medial body axis, the Y device axis from the ideal Y axis or superior-inferior body axis, and the Z device axis from the ideal Z axis or anterior-posterior body axis following implantation of the medical device comprising;

means for measuring a first set of DC accelerometer output signals from said X, Y and Z DC accelerometers while the patient is in a first body posture such that the Y device axis is nominally in alignment with earth'"'"'s gravitational field and the X and Z device axes are nominally normal to earth'"'"'s gravitational field;

means for measuring a second set of DC accelerometer output signals from said X, Y and Z DC accelerometers while the patient is in a second body posture orthogonal to said first body posture wherein one of the X or Z device axes is generally in alignment with earth'"'"'s gravitational field and the other of the X and Z device axes and the Y device axis are nominally normal to earth'"'"'s gravitational field;

means for deriving a pitch angle of the Y and Z device axes from the Y and Z ideal axis respectively, due to rotation of the Y and Z device axes about the X device axis from said first and second sets of DC accelerometer output signals;

means for deriving a yaw angle of the X and Z device axes from the ideal X and Z axis, respectively, due to rotation of the X and Z device axes about the Y device axis from said first and second sets of DC accelerometer output signals; and

means for deriving a roll angle of the X and Y device axes from the ideal X and Y axis, respectively, due to rotation of the X and Y device axes about the Z device axis from said first and second sets of DC accelerometer output signals; and

in a normal operating mode, means operable for determining an unknown body posture of the patient comprising;

means for measuring the X, Y and Z DC accelerometer output signals while the patient is in the unknown body posture;

means for correcting the measured X, Y, and Z DC accelerometer output signals employing the derived pitch, roll and yaw angles to derive corrected X, Y and Z DC accelerometer output signals; and

means for determining the body posture of the patient employing the corrected X, Y and Z DC accelerometer output signals.

28. The system of claim 27, further comprising:

means for defining a set of X, Y, and Z thresholds for each body posture that the patient can assume with respect to earth'"'"'s gravitational field; and

wherein the body posture determining means further comprises;

means for comparing the magnitudes and polarities of the corrected X, Y and Z DC accelerometer output signals with the X, Y and Z respective thresholds of each set of thresholds; and

means for determining the body posture of the patient corresponding to the set of thresholds that is met by the X, Y and Z corrected DC accelerometer output signals.

29. The system of claim 27, wherein the defining means further comprises means for defining the sets of thresholds in relation to characteristic magnitudes and polarities of the DC accelerometer output signals on alignment of the device axes of the X, Y and Z DC accelerometers with or normal to earth'"'"'s gravitational field in each body posture.

30. The system of claim 27, wherein the defining means further comprises means for defining the sets of thresholds in relation to characteristic magnitudes and polarities of the DC accelerometer output signals on alignment of the device axes of the X, Y and Z DC accelerometers with or normal to earth'"'"'s gravitational field in each body posture, including the upright body posture while standing or walking or running, a sitting body posture, a supine body posture, a prone body posture and left and right side lying body postures.

31. The system of any of the claims 27-30, further comprising means for storing said determined body posture of the patient.

32. The system of any of the claims 27-30, further comprising means for delivering a treatment therapy to the patient having a treatment parameter dependent on the determined body posture.

33. The system of any of the claims 27-30, further comprising:

means for storing said determined body posture of the patient; and

means for delivering a treatment therapy to the patient having a treatment parameter dependent on the determined body posture.

34. The system of any of the claims 27-30, further comprising:

means for defining a characteristic activity magnitude of at least one of the X, Y and Z DC accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying a threshold patient activity level;

means for deriving an activity level signal from said at least one of the X, Y or Z DC accelerometer signals exceeding said characteristic activity magnitude over a predetermined time period; and

means for delivering a treatment therapy to the patient having a treatment parameter dependent on the determined body posture and the activity level signal of the patient.

35. The system of any of the claims 27-30, further comprising:

means for defining a characteristic activity magnitude of at least one of the X, Y and Z DC accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying a threshold patient activity level; and

means for deriving an activity level signal from said at least one of the X, Y or Z DC accelerometer signals exceeding said characteristic activity magnitude over a predetermined time period.

36. The system of any of the claims 27-30, further comprising:

means for defining a characteristic activity magnitude of at least one of the X, Y and Z DC accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying a threshold patient activity level;

means for deriving an activity level signal from said at least one of the X, Y or Z DC accelerometer signals exceeding said characteristic activity magnitude over a predetermined time period; and

means for storing said determined body posture and activity level of the patient.

37. The system of any of the claims 27-30, wherein the first body posture is the upright standing body posture and the second body posture is a selected one of the supine body posture, prone body posture, left side lying body posture, and right side lying body posture.

38. The system of any of the claims 27-30 wherein the device'"'"'s ideal axes are nominally defined as having orthogonal gravitational axes comprising an ideal Y-axis aligned with the superior-inferior body axis and aligned with the earth'"'"'s gravitational field, so as to measure 1 g of acceleration when the patient is in an upright body posture, an ideal X-axis normal to the ideal Y-axis aligned with the lateral-medial body axis and orthogonal to the earth'"'"'s gravitational field, so as to measure 0 g of acceleration when the patient is in an upright body posture, and an ideal Z-axis normal to the ideal X-axis and the ideal Y-axis and aligned to the anterior-posterior body axis and orthogonal to the earth'"'"'s gravitational field, so as to measure 0 g of acceleration when the patient is in an upright body posture;

and wherein the first body posture is the upright standing body posture and the second body posture is a selected one of the supine body posture, prone body posture, left side lying body posture, and right side lying body posture;

wherein

said first set of DC accelerometer output signals from said X, Y and Z DC accelerometers is measured while the patient is in the upright standing body posture such that the Y device axis is nominally in alignment with the earth'"'"'s gravitational field and the X and Z device axes are nominally normal to the earth'"'"'s gravitational field; and

said second set of DC accelerometer output signals from said X, Y and Z DC accelerometers is performed while the patient is in a selected one of the supine body posture, prone body posture, left side lying body posture, and right side lying body posture wherein one of the X or Z device axes is generally in alignment with the earth'"'"'s gravitational field and the other of the X or Z device axes and the Y device axis are nominally normal to the earth'"'"'s gravitational field.

65. A device as set forth in any of claims 27-30 or 39-42 or 58-62 wherein a memory means is adapted to store posture related data derived from said accelerometer signals, taken over time, and having telemetry means for transmitting said posture related data to an external device.

66. A device as set forth in any of claims 27-30 or 39-42 or 58-62 wherein a memory means is adapted to store posture related data derived from said accelerometer signals, taken over time, and having program means for determining from a detection of heart rate drop and at least partly from said position signals whether a condition of vasovagal syncope is likely to occur and to cause a stimulation circuit to deliver pacing stimulation at a support rate if said determination is positive.

67. A device as set forth in any of claims 27-30 or 39-42 or 58-62 wherein a memory means is adapted to store posture related data derived from said accelerometer signals, taken over time, and having program means for determining at least partly from said signals whether a patient is in an upright position and if not, then preventing the delivery of support pacing for vasovagal syncope.

68. A device as set forth in any of claims 27-30 or 39-42 or 58-62 wherein a memory means is adapted to store posture related data derived from said accelerometer signals, taken over time, and having program means adapted to trigger support pacing stimulation to an orthostatic hypotensive patient'"'"'s heart if the patient is determined to be going to an upright posture from said posture related data.

39. An implantable medical device employing a system of determining the body posture of a patient'"'"'s body, having an ideal Y axis or superior-inferior body axis, an ideal Z axis or anterior-posterior body axis and an ideal X-axis or lateral-medial body axis, in relation to earth'"'"'s gravitational field, comprising:

a multi-axis, solid state sensor, comprising X, Y and DC accelerometers having X, Y and Z device axes, respectively, orthogonally disposed to one another, which provide X, Y and Z DC accelerometer output signals, respectively, of a magnitude and polarity dependent on the degree of alignment of the respective device axis with earth'"'"'s gravitational field, the multi-axis, solid state sensor associated with the implantable medical device and adapted to be implanted in the patient'"'"'s body so that the X device axis is nominally aligned with the lateral-medial body axis,

means operable assuming a minimal deviation of the yaw angle or the rotation of the X and Z device axis around the Y device axis at the site of implantation for correcting for deviations in alignment of the actual device axes from the ideal device axes,

means for determining that the patient is in an upright body posture wherein said Y device axis is nominally aligned with earth'"'"'s gravitational field and X and Z device axes are nominally normal to earth'"'"'s gravitational field;

means for setting a yaw angle of the X and Z device axes from the ideal X and, respectively, at a fixed value based on the assumption of minimal rotation of the X and Z device axes around the Y device axis

means for measuring at least one set of DC accelerometer output signals from the X, Y, and Z DC accelerometers while the patient is in the assumed upright body posture;

means for deriving a pitch angle of the Y and Z device axes from the ideal Y and Z device respectively, due to rotation of the Y and Z device axes about the X device axis from the measured set of DC accelerometer output signals; and

means for deriving a roll angle of the X and Y device axes from the ideal X and Y axes, respectively, due to rotation of the X and Y device axes about the Z device axis from the measured set of DC accelerometer output signals; and

in a normal operating mode, means for determining an unknown posture of the patient comprising;

means for measuring the X, Y and Z DC accelerometer output signals;

means for correcting the measured X, Y and Z DC accelerometer output signals employing the stored pitch, roll and yaw angles to derive corrected X, Y and Z DC accelerometer output signals; and

means for determining the body posture of the patient employing the corrected X, Y and Z DC accelerometer output signals.

40. The system of claim 39, further comprising:

means for defining a set of X, Y and Z thresholds for each body posture that the patient can assume with respect to the orthogonal gravitational axes; and

wherein the body posture determining means further comprises;

means for comparing the magnitudes and polarities of the corrected X, Y and Z DC accelerometer output signals with the X, Y and Z=respective thresholds of each set of thresholds; and

means for determining the body posture of the patient corresponding to the set of thresholds that is met by the X, Y and Z corrected DC accelerometer output signals.

41. The system of claim 39, wherein the defining means further comprises means for defining the sets of thresholds in relation to characteristic magnitudes and polarities of the DC accelerometer output signals on alignment of the device axes of the X, Y and Z DC accelerometers with or normal to earth'"'"'s gravitational field in each body posture.

42. The system of claim 39, wherein the defining means further comprises means for defining the sets of thresholds in relation to characteristic magnitudes and polarities of the DC accelerometer output signals on alignment of the device axes of the X, Y and Z DC accelerometers with or normal to earth'"'"'s gravitational field in each body posture, including the upright body posture while standing or walking or running, a sitting body posture, a supine body posture, a prone body posture and left and right side lying body postures.

43. The system of any of the claims 39-42, further comprising means for storing said determined body posture of the patient.

44. The system of any of the claims 39-42, further comprising means for delivering a treatment therapy to the patient having a treatment parameter dependent on the determined body posture.

45. The system of any of the claims 39-42, further comprising:

means for storing said determined body posture of the patient; and

means for delivering a treatment therapy to the patient having a treatment parameter dependent on the determined body posture.

46. The system of any of the claims 39-42, wherein means for determining that the patient is in an upright body posture further comprises:

means for defining a characteristic activity magnitude of at least one of the first, second and third DC accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying a threshold patient activity level; and

means for deriving an activity level signal from said at least one of the first, second or third DC accelerometer signals exceeding said characteristic activity magnitude over a predetermined time period that is characteristic of the patient walking in an upright body posture.

47. The system of any of the claims 39-42, wherein:

the means for determining that the patient is in an upright body posture further comprises;

means for defining a characteristic activity magnitude of at least one of the first, second and third DC accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying that the patient is walking in an upright body posture; and

means for determining that the patient is walking when the current magnitude of at least one of the X, Y and Z DC accelerometer output signals matches or exceeds the characteristic activity magnitude over a predetermined time period that is characteristic of the patient walking in an upright body posture; and

the means for measuring a set of DC accelerometer output signals from the X, Y and Z DC accelerometers in the assumed upright body posture is operable for measuring a plurality of sets of DC accelerometer output signals from the X, Y and Z DC accelerometers in the assumed upright body posture, and further comprises;

means for averaging each set of measured DC accelerometer output signals from the X, Y and Z DC accelerometers to derive an averaged set of DC accelerometer output signals.

48. The system of any of the claims 39-42, wherein:

the means for determining that the patient is in an upright body posture further comprises;

means for defining a characteristic activity magnitude of at least one of the X, Y and Z DC accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying that the patient is walking in an upright body posture; and

means for determining that the patient is walking when the current magnitude of at least one of the X, Y and Z DC accelerometer output signals matches or exceeds the characteristic activity magnitude over a predetermined time period that is characteristic of the patient walking in an upright body posture;

the means for measuring a set of DC accelerometer output signals from the X, Y and Z DC accelerometers in the assumed upright body posture is operable for measuring a plurality of sets of DC accelerometer output signals from the X, Y and Z DC accelerometers in the assumed upright body posture, and further comprises;

means for averaging each set of measured DC accelerometer output signals from the X, Y and Z DC accelerometers to derive an averaged set of DC accelerometer output signals; and

the means for deriving pitch angle and roll angle further comprise;

means for periodically deriving a pitch angle of the Y and Z device axes from the ideal Y and Z axes, respectively, due to rotation of the Y and Z device axes about the X device axis from the measured and averaged set of DC accelerometer output signals; and

means for periodically deriving a roll angle of the X and Y device sensitive axes from the ideal X and Y device axes, respectively, due to rotation of the X and Y device axes about the Z device axis from the measured and averaged set of DC accelerometer output signals.

49. The system of any of the claims 39-42, further comprising:

means for defining a characteristic activity magnitude of at least one of the X, Y and Z DC accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying a threshold patient activity level; and

means for deriving an activity level signal from said at least one of the X, Y or Z DC accelerometer signals exceeding said characteristic activity magnitude over a predetermined time period.

50. The system of any of the claims 39-42, further comprising:

means for defining a characteristic activity magnitude of at least one of the X, Y and Z DC accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying a threshold patient activity level;

means for deriving an activity level signal from said at least one of the X, Y and Z DC accelerometer signals exceeding said characteristic activity magnitude over a predetermined time period; and

means for delivering a treatment therapy to the patient having a treatment parameter dependent on the determined body posture and the activity level signal of the patient.

51. The system of any of the claims 39-42, further comprising:

means for defining a characteristic activity magnitude of at least one of the X, Y and Z DC accelerometer output signals effected by body movement occurring within a predetermined frequency range signifying a threshold patient activity level;

means for deriving an activity level signal from said at least one of the X, Y or Z DC accelerometer signals exceeding said characteristic activity magnitude over a predetermined time period; and

means for storing said determined body posture and activity level of the patient.

52. The system of any of the claims 39-42 wherein an ideal coordinate system is nominally defined as having ideal axes comprising an ideal Y axis aligned with the superior-inferior body axis and aligned to the earth'"'"'s gravitational field, so as to measure 1 g of acceleration when the patient is in an upright body posture, an ideal X-axis normal to the ideal Y-axis and nominally aligned with the lateral-medial body axis, so as to measure 0 g of acceleration when the patient is in an upright body posture, and an ideal Z-axis normal to the ideal X-axis and the ideal Y-axis and nominally aligned to the anterior-posterior body axis, so as to measure 0 g of acceleration when the patient is in an upright body posture, and wherein:

said multi-axis, solid state sensor is adapted to be implanted in the patient'"'"'s body so that the X device axis is nominally aligned with the lateral-medial body axis, the Y device axis is nominally aligned with the superior-inferior body axis, and the Z device axis is nominally aligned with the anterior-posterior body axis; and

said means for measuring a set of DC accelerometer output signals from said, Y and Z DC accelerometers is operable while the patient is in an assumed upright body posture such that the Y device axis is nominally in alignment with the earth'"'"'s gravitational field and the X and Z device axes are nominally normal to the earth'"'"'s gravitational field.

53. A method of determining the physical posture of a patient'"'"'s body, having an ideal Y axis, an Z axis, and an ideal X axis, in relation to earth'"'"'s gravitational field comprising the steps of:

implanting a multi-axis, solid state sensor, comprising X, Y and Z DC accelerometers having X, Y and Z device axes, respectively, which respond to earth'"'"'s gravitational field to provide X, Y and Z respective DC accelerometer signals of a magnitude and polarity dependent on the degree of alignment therewith, in the patient'"'"'s body so that said X, Y and Z device axes are generally aligned with said lateral-medial, superior-inferior, and anterior-posterior body axes, respectively;

in a calibration mode wherein the patient is in at least one known or assumed body posture;

deriving a pitch angle of the Y and Z axes from the ideal Y and Z device axes respectively, due to rotation of the Y and Z device axes about the X device axis;

deriving a yaw angle of the X and Z device axes from the ideal X and Z axes, respectively, due to rotation of the X and Z device axes about the Y device axes; and

deriving a roll angle of the X and Y device axes from the ideal X and Y axes, respectively, due to rotation of the X and Y device axes about the Z device axis; and

in a normal operating mode;

measuring X, Y and Z measured DC accelerometer signals from said X, Y and Z DC accelerometers, respectively, in an unknown body posture that the patient assumes;

correcting the measured X, Y and Z DC accelerometer signals to compensate for derived pitch, roll and yaw angles resulting from mis-alignment of said X, Y and Z device axes with said ideal X, Y and axes, respectively; and

determining the body posture of the patient from the corrected X, Y and Z DC accelerometer signals.

54. The method of claim 53, wherein said correcting step further comprises the steps of:

calculating correction factors from the derived pitch angle, roll angle and yaw angle for correction of the measured corrected X, Y and Z DC accelerometer output signals in the correcting step.

55. The method of claim 53, wherein said correcting step further comprises the steps of:

calculating correction factors from the derived pitch angle, roll angle and yaw angle for correction of the measured corrected X, Y and Z DC accelerometer output signals in the correcting step; and

storing the correction factors for use in the correcting step for a time period until the next derivation of the pitch angle, roll angle and yaw angle and calculation of the correction factors.

56. The method of any of the claims 53-55, wherein the step of deriving the yaw angle comprises setting the yaw angle of the X and Z device axes from the ideal X and Z, respectively, at a fixed value based on the assumption of minimal rotation of X and Z device axes about the Y device axes.

57. The method of any of the claims 53-55, further comprising the step of:

defining a set of X, Y and Z thresholds for each body posture that the patient can assume with respect to the orthogonal gravitational axes from a first characteristic magnitude and polarity of said X, Y and Z DC accelerometer signals on alignment of the sensitive axes of said X, Y and Z DC accelerometers with earth'"'"'s gravitational field, a second magnitude and polarity of said X, Y and Z DC accelerometer signals on alignment with the earth'"'"'s gravitational field, and a third characteristic magnitude and polarity of said X, Y and Z DC accelerometer signals; and

wherein said determining step further comprises the steps of;

comparing the magnitudes and polarities of the X, Y and Z DC accelerometer output signals with X, Y and Z respective thresholds of each set of thresholds; and

determining the body posture of the patient corresponding to the set of thresholds that is met by the X, Y and Z corrected DC accelerometer output signals.

60. An implantable medical device having a system for determining the physical posture of a patient'"'"'s body, having an ideal Y axis, an ideal Z axis and an ideal X axis, in relation to earth'"'"'s gravitational field comprising:

a multi-axis, solid state sensor, comprising X, Y and Z DC accelerometers having X, Y and Z device axes, respectively, orthogonally disposed to one another, which provide X, Y and Z DC accelerometer output signals, respectively, of a magnitude and polarity dependent on the degree of alignment of the respective device axis with the earth'"'"'s gravitational field, the multi-axis, solid state sensor associated with the implantable medical device and adapted to be implanted in the patient'"'"'s body so that the X device axis is nominally aligned with the lateral-medial body axis, the Y device axis is nominally aligned with the superior-inferior body axis, and the Z device axis is nominally aligned with the anterior-posterior body axis;

means for correcting for deviations in alignment of the X device axis from the ideal X axis or lateral-medial body axis, the Y device axis from the ideal Y axis or superior-inferior body axis, and the Z device axis from the ideal Z axis or anterior-posterior body axis following implantation of the medical device comprising;

means operable in a calibration mode with the patient in at least one known or assumed body posture for deriving a pitch angle of the Y and Z device axes from the ideal Y and Z axes, respectively, due to rotation of the Y and Z device axes about the X device axis in the implantation step;

means operable in the calibration mode with the patient in at least one known or assumed body posture for deriving a yaw angle of the X and Z device axes from the ideal X and Z axes, respectively, due to rotation of the X and Z device axes about the Y device axis in the implantation step; and

means operable in the calibration mode with the patient in at least one known or assumed body posture for deriving a roll angle of the X and Y device axes from the ideal X and Y axes, respectively, due to rotation of the X and Y axes about the Z device axis in the implantation step;

means operable in a normal operating mode when the patient assumes an unknown body posture for deriving X, Y and Z measured DC accelerometer signals from said X, Y and Z DC accelerometers, respectively;

means for correcting the measured X, Y and Z DC accelerometer signals for determined pitch, roll and yaw angular deviations resulting from mis-alignment of said X, Y and Z device axes with said ideal X, Y and Z axes, respectively; and

means for determining the body posture of the patient from the corrected X, Y and Z DC accelerometer signals.

61. The system of claim 60, wherein said correcting means further comprises means for calculating correction factors from the derived pitch angle, roll angle and yaw angle for correction of the measured corrected X, Y and Z DC accelerometer output signals in the correcting step.

62. The system of claim 60, wherein said correcting means further comprises:

means for calculating correction factors from the derived pitch angle, roll angle and yaw angle for correction of the measured corrected X, Y and Z DC accelerometer output signals in the correcting step; and

means for storing the correction factors for use in the correcting step for a time period until the next derivation of the pitch angle, roll angle and yaw angle and calculation of the correction factors.

63. The system of any of the claims 60-62, wherein the yaw angle deriving means further comprises means for setting the yaw angle of the X and Z device axes from the ideal X and Z axes, respectively, at a fixed value based on the assumption of minimal rotation of X and Z device axes about the Y device axis.

64. The system of any of the claims 60-62, further comprising:

a set of X, Y and Z thresholds for each body posture that the patient can assume with respect to the orthogonal gravitational axes from a first characteristic magnitude and polarity of said X, Y and Z DC accelerometer signals on alignment of the sensitive axes of said X, Y and Z DC accelerometers with earth'"'"'s gravitational field, a second magnitude and polarity of said X, Y and Z DC accelerometer signals on alignment against earth'"'"'s gravitational field, and a third characteristic magnitude and polarity of said X, Y and Z DC accelerometer signals; and

wherein said determining means further comprises;

means for comparing the magnitudes and polarities of the corrected X, Y and Z DC accelerometer output signals with the X, Y and Z respective thresholds of each set of thresholds; and

means for determining the body posture of the patient corresponding to the set of thresholds that is met by the X, Y and Z corrected DC accelerometer output signals.