Device and method for automatically adjusting tachycardia recognition criteria based on detected parameter

• US 5,370,667 A
• Filed: 07/20/1992
• Issued: 12/06/1994
• Est. Priority Date: 04/03/1992
• Status: Expired due to Fees

• Current Assignee: Advanced Medical Optics Incorporated (Johnson & Johnson)
• Original Assignee: Intermedics Incorporated (Boston Scientific Corporation)
• Inventors: Alt, Eckhard
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US07/916,588
• Time in Patent Office: 869 Days
• Field of Search: 128/670, 128/702, 128/705, 128/706, 128/782, 607/18, 607/19, 607/14, 607/15
• US Class Current: 607/19
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• 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
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/395 for treating atrial fibrillation
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

An implantable medical interventional device delivers electrical therapies to the heart of the implant patient to treat pathological tachycardia. A first sensor of the device generates a signal indicative of the patient'"'"'s ECG, and a second sensor in the form of an activity sensor such as an accelerometer generates a signal representative of the current status of physical exercise by the patient. An evaluation system of the device establishes heart rate criteria for recognizing pathological tachycardias, to be applied against the ECG signal to recognize pathological tachycardia and distinguish it from physiological tachycardia experienced by the patient. A control system of the device modifies the criteria according to the nature of the exercise status signal, to enhance recognition and distinction. In an embodiment, the criteria of heart rate at the boundary between physiological and pathological tachycardia for the particular implant patient is modified by shifting it to a different rate. The boundary rate is shifted to a higher rate when the exercise status signal indicates a change from patient rest to patient exercise, and to a lower rate when that signal indicates a change from patient exercise to patient rest. Bipolar floating electrodes sense atrial ECG status, and solely atrial defibrillation is applied when ventricular tachycardia is found attributable to primary atrial fibrillation. Such a situation may be determined by measuring the R-R interval of the beats to detect irregularity. The modification of the tachycardia recognition criteria is disabled when primary atrial fibrillation is detected.

Claims

1. An implantable medical interventional device for generating electrical therapies for delivery to the heart of the implant patient to treat pathological tachycardia, comprising:

first sensor means adapted to produce a signal indicative of the patient'"'"'s ECG,

second sensor means adapted to produce a signal representative of the current status of physical exercise by the patient,

evaluation means for establishing criteria for recognizing pathological tachycardias, including means for applying said criteria against the ECG signal produced by the first sensor means to recognize pathological tachycardia and distinguish it from physiological tachycardia experienced by the patient,

control means for automatically modifying at least one of said criteria according to the nature of the signal produced by the second sensor means, for application against said ECG signal to enhance the recognition and distinction of pathological tachycardia, and

generator means for generating an appropriate one of said electrical therapies to be delivered to the patient'"'"'s heart for treating the recognized pathological tachycardia.

2. The implantable medical interventional device of claim 1, in which:

the second sensor means comprises a physical activity sensor.

3. The implantable medical interventional device of claim 2, in which:

the physical activity sensor is an accelerometer.

4. The implantable medical interventional device of claim 2, wherein:

the second sensor means comprises an integrated electronic circuit including silicon based microminiature mechanoelectrical converter means responsive to orientation and movement thereof for producing said exercise status signal.

5. The implantable medical interventional device of claim 4, wherein:

the mechanoelectrical converter means is selected from the group consisting of piezoelectric, piezoresistive and piezocapacitive converters, to convert patient movement and physical position to an electrical signal representative thereof.

6. The implantable medical interventional device of claim 2, wherein:

the second sensor means comprises an accelerometer for converting patient movement and physical position to an electrical signal representative thereof.

7. The implantable medical interventional device of claim 1, in which:

said evaluation means comprises means for establishing as said at least one of said criteria to be modified by said control means a heart rate which is deemed to be the boundary between physiological tachycardia and pathological tachycardia for the particular implant patient, and

the control means comprises modifying means responsive to the current status of physical exercise by the patient as represented by the signal produced by the second sensor means, for automatically modifying the boundary heart rate by shifting it from a first rate to a different rate upon a change in said current status of physical exercise.

8. The implantable medical interventional device of claim 7, in which:

said modifying means comprises shifting means for shifting the boundary heart rate to a higher rate when the signal generated by the second sensor means indicates a change from patient rest to patient exercise, and for shifting the boundary heart rate to a lower rate when the signal generated by the second sensor means indicates a change from patient exercise to patient rest.

9. The implantable medical interventional device of claim 8, in which:

the shifting means comprises means for returning the rate to the original boundary rate when the signal generated by the second sensor means indicates a change from patient exercise to patient rest.

10. The implantable medical interventional device of claim 8, in which:

the second sensor means is an accelerometer.

11. In an implantable defibrillator for detecting and treating abnormal tachycardias experienced by the implant patient and including means for distinguishing abnormal tachycardias from normal elevated heart rates of the patient by the application of distinction criteria, the improvement comprising:

means responsive to changes in a physiological parameter which signify a basis for normal elevation of heart rate of the patient, for modifying the distinction criteria to enhance the capability of the defibrillator to make the distinction.

12. The improvement of claim 11, wherein:

the parameter is other than the patient'"'"'s intrinsic electrical heart activity.

13. The improvement of claim 12, wherein:

the parameter is related to the status of exercise by the patient.

14. The improvement of claim 13, wherein:

the parameter is patient activity.

15. The improvement of claim 11, wherein:

one of the distinction criteria is a threshold heart rate above which the patient is presumed to be experiencing a pathological tachycardia, and the parameter responsive means includes means for detecting changes in the parameter and means for shifting the threshold rate up or down depending on the nature of the changes.

16. The improvement of claim 15, wherein:

the detecting means is an activity sensor.

17. The improvement of claim 16, wherein:

the activity sensor comprises an accelerometer.

18. A method for detecting pathological tachycardia by means of a medical interventional device implanted in a patient, to determine when to deliver electrical therapy from the device to the patient'"'"'s heart to treat the pathological tachycardia, comprising the device-implemented steps of:

sensing the patient'"'"'s cardiac activity and status of physical exercise and producing an ECG signal and an exercise status signal respectively representative thereof,

setting criteria for evaluating the ECG signal to recognize onset and continuation of pathological tachycardia,

modifying at least one of the criteria according to a change in the status of rest or exercise of the patient as determined from the exercise status signal,

applying the at least one modified criterion to the ECG signal to recognize pathological tachycardia in the changed status, and

selecting and generating an electrical therapy for delivery to the patient'"'"'s heart to treat a recognized pathological tachycardia.

19. The method of claim 18, in which:

the step of sensing the patient'"'"'s status of physical exercise is performed by sensing the patient'"'"'s physical activity.

20. The method of claim 19, in which:

the step of modifying at least one of the criteria is performed by modifying a heart rate criterion of a boundary between heart rates of the patient indicative physiological tachycardia and heart rates indicative of pathological tachycardia, by shifting the heart rate boundary criterion up or down according to whether increased or decreased patient activity is sensed, respectively.

21. The method of claim 18, in which

the step of setting criteria includes setting a threshold heart rate between rates of the patient indicative of physiological and pathological tachycardia, and

the step of modifying includes shifting the threshold heart rate to higher values with commencement and increases of physical exercise by the patient and to lower values with decreases and cessation of physical exercise by the patient.

22. The method of claim 21, further including the steps of:

establishing a tier of electrical therapies for selecting and generating increasingly aggressive therapies with either continuation or acceleration of a recognized pathological tachycardia, and

shifting the tier of therapies up or down with shifting of the threshold rate, according to the exercise status signal.

23. The method of claim 22, wherein:

evaluation of the ECG signal includes using signal information indicative of both the ventricular ECG status and the atrial ECG status.

24. The method of claim 23, wherein:

one of the therapies among the tired electrical therapies which may be selected is solely atrial defibrillation without a concurrent therapy applied to the ventricles.

25. A method for determining which therapy in a tier of electrical therapies is to be applied to the heart of a cardiac patient to treat pathological tachycardia detected in different zones of recognition from criteria applied to evaluation of the patient'"'"'s ECG, including shifting the different zones and the consequent therapies to be applied upwardly or downwardly in response to the status of a physiological parameter of the patient other than the ECG.

26. The method of claim 25, in which the other physiological parameter is patient activity.

27. In a method to detect pathological tachycardia in a patient having an automatic implantable defibrillator, in which the patient'"'"'s ECG is detected and an ECG-based heart rate is selected as a threshold for distinguishing pathological and physiological tachycardias experienced by the patient at least according to whether the heart rate exceeds or does not exceed the selected threshold rate, respectively, the improvement comprising the additional steps of:

employing a non-ECG sensor to generate an output signal in response to detection of a parameter indicative of status of physiological tachycardia of the patient, and

modifying the selected threshold rate depending upon the output signal of the non-ECG sensor.

28. The improved method of claim 27, wherein:

the modification of the selected threshold rate is in a direction to increase the threshold rate when the output signal of the non-ECG sensor indicates that the patient is experiencing physiological tachycardia.

29. The improved method of claim 28, wherein:

the modification of the selected threshold rate is in a direction to decrease the threshold rate when the output signal of the non-ECG sensor indicates that the patient is ceasing to experience the physiological tachycardia.

30. The improved method of claim 27, wherein:

the non-ECG sensor is an accelerometer implanted in the patient to detect the current status of activity and non-activity of the patient.

31. The improved method of claim 30, wherein:

the accelerometer is adapted to additionally detect the current position and change of position of the patient.

32. The improved method of claim 27, wherein:

the parameter indicates the current status of exercise by the patient, and the modification of the selected threshold rate is an increase to a higher rate when the output signal of the non-ECG sensor reflects a change from a state of rest to a state of exercise by the patient, and a decrease to a lower rate when the output signal of the non-ECG sensor reflects a change from a state of exercise to a state of rest by the patient, and further including;

applying an electrical therapy to the patient'"'"'s heart upon recognition of the occurrence of a pathological tachycardia in an effort to terminate the pathological tachycardia and restore a normal heart rate.

33. The improved method of claim 32, wherein:

the modification of the selected threshold rate is a further increase to a still higher rate when the output signal of the non-ECG sensor reflects a predetermined increase in the level of exercise by the patient.

34. The improved method of claim 33, wherein:

the electrical therapy consists of a sequence of protocols intended to break the pathological tachycardia, including defibrillation if the pathological tachycardia progresses to fibrillation.

35. The improved method of claim 34, wherein:

the electrical therapy is tiered to provide a succession of protocols from among ,said sequence according to different zones of heart rates based on the different threshold rates as each threshold rate is increased or decreased to a new threshold rate.

36. The improved method of claim 27, wherein:

the parameter detected by the non-ECG sensor is indicative of the status of exercise by the patient, and is an individual parameter or a combination of parameters selected from the group consisting of patient movement, impact or acceleration indicative of activity, patient blood oxygen content, patient blood pressure, patient blood flow, patient respiration, patient minute ventilation, patient chest impedance, patient pulse rate, and patient blood temperature.

37. An implantable medical interventional device for delivering electrical therapies to the heart of an implant patient to treat pathological ventricular tachycardia, comprising:

first sensor means adapted to generate a signal indicative of the patient'"'"'s ventricular ECG status,

second sensor means adapted to generate a signal indicative of the patient'"'"'s atrial ECG status,

evaluation means for establishing criteria to distinguish physiological and pathological tachycardia in the ventricles from an evaluation of the signal generated by Mid first sensor means and adapted to apply an appropriate therapy in response to an evaluation that a pathological tachycardia is present, said evaluation means including therapy delivering means responsive to the signal generated by said second sensor means indicative of atrial fibrillation or other atrial dysrhythmias for limiting the therapy to an atrial response.

38. The invention of claim 37, in which:

the evaluation means is further adapted to compare the signals indicative of atrial ECG status and ventricular ECG status to discriminate primary ventricular tachycardias from secondary ventricular tachycardias of primary atrial origin, and

the therapy delivering means is adapted to deliver electrical therapies in a tiered regimen and is responsive to said discrimination of primary and secondary ventricular tachycardia to adjust the tiered therapy regimen accordingly.

39. The invention of claim 38, in which:

the tiered therapy regimen includes a therapy of solely atrial defibrillation.

40. The invention of claim 37, further including:

a non-ECG sensor adapted to sense a physiological parameter indicative of patient activity.

41. The invention of claim 40, in which:

the evaluation means is responsive to detection of atrial fibrillation or other atrial dysrhythmia by the second sensor means, detection of ventricular tachycardia by the first sensor means, and an indication of a resting condition or low level activity by the non-ECG sensor, to treat the ventricular tachycardia as pathological atrial tachycardia, and to select atrial defibrillation as the therapy to be applied, without delivery of any therapy to the ventricle.

42. The method of controlling pathological tachycardia whether in the atrium or the ventricles of the heart, including:

sensing atrial and ventricular dysrhythmias,

providing tiered electrical therapies for application to the heart to treat the sensed dysrhythmia, and

responding to a sensed dysrhythmia in the right ventricle and to a sensed atrial dysrhythmia in the right atrium while the patient is substantially at rest, by treating both the ventricular dysrhythmia and the atrial dysrhythmia with one of the tiered therapies applied solely to the atrium.

43. The method of claim 42, in which:

the tiered therapy applied solely to the atrium is defibrillation therapy applied to one of the two atrial poles used for bipolar sensing of the atrial ECG.

44. An implantable medical interventional device for delivering electrical therapies to the heart of an implant patient to treat pathological ventricular tachycardia, comprising:

first sensor means adapted to be positioned in the patient'"'"'s right ventricle to sense ventricular electrical activity,

second sensor means adapted to be positioned in the patient'"'"'s right atrium to sense atrial electrical activity, and

defibrillation electrode means adapted to be positioned in the patient'"'"'s right ventricle to electrically stimulate excitable myocardial tissue thereof;

evaluation means establishing criteria to distinguish ventricular tachycardia of physiological origin and of pathological origin, and responsive to said first and second sensor means for determining whether a pathological ventricular tachycardia is primary, originating from ventricular dysfunction, or secondary, originating from atrial dysfunction; and

control means responsive to said evaluation means for selecting an electrical therapy for delivery to the patient'"'"'s heart;

all of said first and second sensor means and said defibrillation electrode means being disposed on the same electrode structure.

45. The invention of claim 44, including:

another defibrillation electrode means adapted to be positioned in the patient'"'"'s right atrium to electrically stimulate excitable myocardial tissue thereof, on said same electrode structure.

46. The invention of claim 45, wherein:

said another defibrillation electrode means is part of said second sensor means.

47. A method of controlling both atrial and ventricular pathological dysrhythmias, including:

sensing atrial and ventricular dysrhythmias utilizing respective recognition criteria,

normally modifying the recognition criteria for ventricular dysrhythmias if it is determined that the patient is undergoing exercise and removing the modification when the patient returns to a state of rest,

providing tiered electrical therapies for application to the heart to treat the sensed dysrhythmia,

responding to a sensed dysrhythmia in the right ventricle and to a sensed atrial dysrhythmia in the right atrium as indicative that the atrial dysrhythmia is primary, by treating both the ventricular dysrhythmia and the atrial dysrhythmia with one of the tiered therapies applied solely to the atrium, while avoiding modification of the recognition criteria.

48. The method of claim 47, in which:

the step of applying a tiered therapy solely to the atrium is performed by applying a cardioversion therapy applied to an atrial electrode which is also used for sensing the atrial ECG.

49. The method of claim 47, wherein:

the dysrhythmia in the right ventricle is sensed by detecting the R-R interval of the patient'"'"'s electrical cardiac activity.

50. The method of claim 49, wherein:

determination that the ventricular dysrhythmia is arising from atrial dysrhythmia is made upon sensing an irregular R-R interval.

51. An implantable medical interventional device for distinguishing pathologic tachycardia from physiologic tachycardia of a patient, and for promptly generating a selected electrical therapy for delivery to the heart of the patient to treat a detected pathologic tachycardia, comprising:

means for detecting a tachycardia in the patient,

means for establishing at least one criterion by which to distinguish whether a detected tachycardia is pathologic or physiologic based on the patient'"'"'s cardiac activity,

sensor means for generating an electrical signal indicative of the patient'"'"'s cardiac activity,

complementary sensor means for generating an electrical signal representative of the state of physical exercise of the patient,

means responsive to said electrical signal representative of the state of physical exercise of the patient for selectively modifying said at least one criterion according to the nature of the physical exercise, and for applying said at least one criterion as modified against said electrical signal indicative of the patient'"'"'s cardiac activity to assess whether a detected tachycardia is pathologic, and

means for generating one of a plurality of available electrical therapies of the device if the assessment is that a pathologic tachycardia is in progress.

52. The implantable medical interventional device of claim 51, in which:

said complementary sensor means comprises means for generating an electrical signal representative of the state of physical activity of the patient, and

said means responsive to said electrical signal representative of the state of physical exercise of the patient for selectively modifying said at least one criterion according to the nature of the physical exercise comprises means responsive to said electrical signal representative of the state of physical activity of the patient for selectively modifying said at least one criterion according to the nature of the physical activity.

53. The implantable medical interventional device of claim 52, in which:

said complementary sensor means comprises an accelerometer for generating an electrical signal representative of the state of physical activity of the patient.

54. The implantable medical interventional device of claim 52, in which:

said means for establishing at least one criterion by which to distinguish whether a detected tachycardia is pathologic or physiologic comprises means for establishing a boundary rate between heart rates predetermined to be indicative of pathologic and physiologic tachycardia, and

said means responsive to said electrical signal representative of the state of physical activity of the patient for selectively modifying said at least one criterion according to the nature of the physical activity comprises means for varying said boundary rate according to current level of activity of the patient.