Implantable cardiac stimulator for detection and treatment of ventricular arrhythmias

• US 4,830,006 A
• Filed: 06/17/1986
• Issued: 05/16/1989
• Est. Priority Date: 06/17/1986
• Status: Expired due to Term

• Current Assignee: Intermedics Incorporated
• Original Assignee: Intermedics Incorporated
• Inventors: Baker, Ross G. Jr., Calfee, Richard V., Haluska, Edward A., Whistler, Stephen J.
• Primary Examiner(s): Jaworski, Francis
• Assistant Examiner(s): Manuel, George
• Application Number:
  US06/875,218
• Time in Patent Office: 1,064 Days
• Field of Search: 128/419 PG, 128/419 D, 128/696, 128/705, 128/706
• US Class Current: 607/4
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate

Abstract

An implantable cardiac stimulator integrates the functions of bradycardia and anti-tachycardia pacing-type therapies, and cardioversion and defibrillation shock-type therapies. The stimulator is programmable to provide a multiplicity of hierarchical detection algorithms and therapeutic modalities to detect and treat classes of ventricular tachycardia according to position within rate range classes into which the heart rate continuum is partitioned, and thus according to hemodynamic tolerance, with backup capabilities of defibrillation and bradycardia pacing at the higher and lower regions of the rate continuum outside the range of the ventricular tachycardia classes. Aggressiveness of the therapy is increased with elapsed time and increasing heart rate, and detection criteria are relaxed with increasing heart rate and thus with increasing hemodynamic intolerance of the tachycardia.

Claims

1. An implantable cardiac stimulator, comprising

means for detecting cardiac arrhythmias in a predetermined heart rate continuum of a patient,

means responsive to the detection of an arrhythmia for delivering a predetermined therapy regimen from among a multiplicity of available therapy regimens to treat said detected arrhythmia according to the rate thereof, each of said multiplicity of therapy regimens consisting of prescribed electrical stimuli to be delivered to the patient'"'"'s heart and at least some of said plurality of therapy regimens differing from the others with respect to the aggressiveness of the treatment provided by the respective therapy regimens according to the particular characteristics of the respective stimuli and pattern of delivery thereof, and

means responsive to a material change of rate of said detected arrhythmia to automatically institute delivery of a different therapy regimen of greater or lesser aggressiveness than that delivered for treatment of the detected arrhythmia prior to said rate change, for treatment of said changed arrhythmia according to whether the rate change is an increase or a decrease from the prior rate, respectively.

2. The cardiac stimulator of claim 1, in which

said means for detecting arrhythmias includes means for programmably establishing the rate boundaries of the heart rate continuum within which arrhythmias are to be detected.

3. The cardiac stimulator of claim 2, in which

said means for programmably establishing further permits programmably establishing the rate boundaries of a plurality of classes of tachyarrhythmias of contiguous, progressively higher rate ranges within said heart rate continuum.

4. The cardiac stimulator of claim 3, in which

said delivering means includes means for controllably modifying the aggressiveness of the selected therapy regimen during treatment of a detected tachyarrhythmia.

5. The cardiac stimulator of claim 4, in which

said means for controllably modifying prevents the return to a therapy less aggressive than that last delivered, upon acceleration of the tachyarrhythmia to a higher class.

6. The cardiac stimulator of claim 4, in which

said means for controllably modifying produces a repetition of the least aggressive therapies within the previously delivered therapy regimen before proceeding to a redelivery of the entire therapy regimen.

7. The cardiac stimulator of claim 2, in which

said means for detecting further includes means for selectively establishing criteria for detecting each of the potential episodes of bradycardia, tachycardia, fibrillation, and reversion to sinus rate.

8. The cardiac stimulator of claim 7, in which

said means for establishing criteria for detecting tachycardias utilizes the basic criteria of high heart rate, sudden onset of the high rate, stability of the high rate, and sustained high rate.

9. The cardiac stimulator of claim 7, in which

said means for establishing criteria for detecting fibrillation utilizes the basic criteria of high heart rate exceeding the highest rate for detecting tachycardias, and the occurrence of at least x fibrillation intervals out of y consecutive intervals, where x and y are selectible.

10. The cardiac stimulator of claim 3, in which

further including means for redetecting the presence or absence of the earlier detected arrhythmia following delivery of a therapy regimen, said redetecting means being responsive to a change of class of said earlier detected arrhythmia as indicative of said material change of rate.

11. The cardiac stimulator of claim 10, in which

said redetecting means distinguishes an actual acceleration of the redetected arrhythmia to the next higher class from a false indication of such acceleration.

12. The cardiac stimulator of claim 1, in which

said means for delivering includes means for controllably modifying the aggressiveness of the selected therapy regimen during treatment of the detected arrhythmia.

13. The cardiac stimulator of claim 1, in which

said means for delivering includes means for controllably reapplying a therapy identical to that previously applied in response to detection of an arrhythmia, upon the very next incidence of an arrhythmia.

14. The cardiac stimulator of claim 13, in which

said reapplied therapy is identical to the entire last therapy regimen successful in terminating a tachycardia.

15. The cardiac stimulator of claim 13, in which

said reapplied therapy is identical to the last therapy of the overall therapy regimen last successful in terminating a tachycardia.

16. An implantable medical device for treating cardiac arrhythmias, comprising

means for dividing the heart rate spectrum into at least three contiguous, successive regions of progressively higher rate ranges, each of said regions representative of a respective class of arrhythmia,

means for detecting anywhere within said spectrum an arrhythmia of a patient'"'"'s heart,

means for programmably assigning therapies in a regimen for each class according to the rate range thereof, different from the therapy regimens for the other classes, to treat the detected arrhythmia according to the class thereof, and.

means responsive to said detected arrhythmia for automatically delivering at least one of the therapies assigned to the respective class of that arrhythmia for application to the patient'"'"'s heart.

17. The device according to claim 16, further including

means responsive to detection of an arrhythmia outside either of the upper and lower boundaries of the continuum of said regions, for automatically delivering first or second preselected therapies according to whether said activity is outside said upper boundary or said lower boundary, respectively,

said first and second therapies being different in kind from each other and different in degree from the preselected therapy regimens assigned to said regions.

18. The device according to claim 16, further including

means for automatically modifying the preselected therapy regimen to be delivered for any particular class of arrhythmia according to a predetermined therapy control function, in response to the effect of the immediately preceding regimen on the arrhythmia under treatment, during the period said arrhythmia is in progress.

19. The device according to claim 18, in which said arrhyhmias to be treated are tachyarrhythmias,

said means for automatically modifying delivering progressively more aggressive regimens until the tachyarrhythmia under treatment is terminated.

20. The device according to claim 18, in which said arrhythmias to be treated are tachyarrhythmias,

said means for automatically modifying being responsive to the detection of the tachyarrhythmia under treatment as of a rate appearing to be hemodynamically tolerated, to apply a preselected number of repetitions of the less aggressive therapies within the applicable preselected regimen before proceeding to apply the more aggressive therapies within said regimen.

21. A cardiac stimulator for detecting and treating tachyarrhythmias, comprising

means for selectively dividing the heart rate continuum into at least two classes of tachycardia, contiguous to each other and of progressively higher heart rate ranges, the lowest and highest of said classes being bounded respectively by a sinus rate region and a fibrillation region of the continuum,

means for selectively adjusting the boundaries between said classes and between the lowest and highest of said classes and the respective sinus rate and fibrillation regions, to correspondingly vary the rate ranges of said classes in a desired manner,

means for selectively detecting cardiac episodes within any of said classes and for distinguishing between normal and abnormal tachycardias among such episodes, and

means responsive to detection of an abnormal tachycardia for selectively treating same with any of a multiplicity of therapy regimens of selectively varying aggressiveness toward terminating said detected tachycardia.

22. The cardiac stimulator of claim 21, in which

said treating means includes means responsive to acceleration of a detected tachycardia into said fibrillation region for automatically applying defibrillation therapy to the patient'"'"'s heart.

23. The cardiac stimulator of claim 21 or claim 22, in which

said detecting means includes means for sensing a loss of electrical activity of the patient'"'"'s heart, and

said treating means includes means responsive to the sensed loss of electrical activity for automatically applying electrical stimulating pulses to the heart for pacing the heart until resumption of the heart'"'"'s normal electrical activity.

24. The cardiac stimulator of claim 21, further including

means for programmably controlling the sequence in which therapies in said regimens are applied by said treating means in response to detection of an abnormal tachycardia within any of said classes.

25. The cardiac stimulator of claim 21, in which

said detecting means includes means for selectively redetecting the presence or absence of an abnormal tachycardia in any of said classes after each application of a therapy regimen by said treating means, said redetecting means applying only some of the criteria applied by said detecting means for the initial detection of the tachycardia.

26. The cardiac stimulator of claim 21, in which

said detecting means includes means for sensing acceleration of the rate of a detected tachycardia to a higher one of said classes, and

said treating means is responsive to the sensed acceleration to thereupon deliver a therapy regimen preselected for a tachycardia of said higher class.

27. The cardiac stimulator of claim 21, in which

said therapy regimens include both pacing therapy and shock therapy, the two types of therapy differing in at least the level of electrical energy applied to the heart.

28. The cardiac stimulator of claim 27, in which

each of said pacing and shock therapies is selectively variable in at least one characteristic of the electrical waveform constituting a portion of the respective therapy.

29. The cardiac stimulator of claim 21, in which

said detecting means includes means for sensing reversion of the patient'"'"'s heart rate to sinus rhythm.

30. An implantable medical device for treating cardiac arrhythmias, comprising

means for dividing the heart rate continuum into a plurality of contiguous, progressively higher rate ranges bounded by rates indicative of normal sinus rhythm and fibrillation, respectively, by which to classify an arrhythmia according to rate range within which it arises,

means for detecting anywhere within said rate continuum an arrhythmia, said detecting means including means for applying different detection criteria to the different rate ranges, said different detecting criteria being progressively less stringent as said rate ranges become progressively higher, to reflect the increasing hemodynamic intolerance with increasing rate of the arrhythmia and

means for stimulating the heart responsive to the detection of an arrhythmia.

31. The medical device of claim 30, in which

said detecting means further includes means for eliminating at least some of said detecting criteria for redetecting the presence or absence of the previously detected arrhythmia upon treatment thereof, to expedite the redetection.

32. The medical device of claim 30, in which

said detecting means includes means for distinguishing said arrhythmia from a normal cardiac episode within at least some of said rate ranges.

33. The medical device of claim 32, in which

said detecting means further includes means for detecting a change in rate of said arrhythmia from one of said rate ranges to another.

34. The medical device of claim 33, in which

said rate change detecting means includes means for detecting a change in rate of said arrhythmia to an arrhythmia outside said rate ranges.

35. The medical device of claim 32, in which

said rate change detecting means further includes means for distinguishing an actual acceleration of the detected arrhythmia to a higher rate range from a false indication of such acceleration.

36. An implantable therapy generator for treating ventricular arrhythmias, comprising

means for programmably dividing the heart rate continuum into a plurality of contiguous rate ranges each representing a different tachycardia class by selectively assigning a rate to the boundary between adjacent pairs of the rate ranges, said plurality of rate ranges being bounded at the lower end by a sinus rate region and at the upper end by a fibrillation rate region,

means for detecting a tachycardia within any of the tachycardia classes and for distinguishing whether said tachycardia is a normal or abnormal cardiac episode, and

means responsive to detection of said tachycardia as an abnormal cardiac episode for delivering to the heart a therapy regimen selected according to the class in which said tachycardia is detected, said regimen differing from at least one of the regimens available to be delivered in response to detection of an abnormal cardiac episode in another of the tachycardia classes.

37. The implantable therapy generator of claim 36, further including

means for detecting an acceleration of an abnormal cardiac episode into said fibrillation region, and

means responsive to detection of said acceleration for delivering a defibrillating therapy.

38. The implantable therapy generator of claim 37, further including

means for detecting an absence of cardiac activity following delivery of said defibrillating therapy, and

means responsive to said detection of an absence of cardiac activity for delivering stimulating pulses to reestablish normal cardiac activity.

39. The implantable therapy generator of claim 36, in which

said detecting means includes means for redetecting the abnormal cardiac episode following delivery of said therapy regimen, and

said therapy regimen delivering means includes means for redelivering a therapy regimen upon redetection of the abnormal cardiac episode, consistent with the class in which said episode is redetected.

40. The implantable therapy generator of claim 36, further including

means for modifying the criterion for detecting a tachycardia within a class after delivery of said therapy regimen.

41. The implantable therapy generator of claim 36, in which

said detecting means includes means for establishing detection criteria for each of said tachycardia classes, ranging from the most stringent of said criteria for the class having the lowest rate range to the most relaxed of said criteria for the class having the highest rate range.

42. The implantable therapy generator of claim 39, further including

means for detecting a return of cardiac activity to said sinus rate region after each delivery of a therapy regimen.

43. The implantable therapy generator of claim 36, in which

said means for delivering a therapy regimen includes means for repetitively delivering the same therapy regimen in response to repeated redetection of said abnormal cardiac episode within the same tachycardia class, and for delivering a different therapy regimen in response to redetection of said abnormal cardiac episode as having undergone a change of rate to a different class.

44. The implantable therapy generator of claim 43, further including

means for selectively establishing the aggressiveness of the therapy regimens with which detected abnormal cardiac episodes are treated.

45. The implantable therapy generator of claim 44, further including

means for modifying the previously established aggressiveness of a therapy regimen while a detected abnormal cardiac episode is in progress.

46. The implantable therapy generator of claim 36, in which

said detecting means further includes means for detecting a bradycardia, and

said therapy regimen delivering means further includes means responsive to detection of a bradycardia for delivering pacing therapy.

47. The implantable therapy generator of claim 36, in which

said detecting means further includes means for detecting an arrhythmia within said fibrillation region, and

means responsive to detection of an arrhythmia within said fibrillation region for delivering defibrillation therapy.

48. The implantable therapy generator of claim 36, in which

said therapy regimen delivering means is selectively adjustable to deliver pacing therapy, shock therapy or a combination of pacing therapy and shock therapy as the therapy regimen to be delivered in response to detection of an abnormal cardiac episode in each of the tachycardia classes.

49. An implantable medical device for treating ventricular cardiac arrhythmias, comprising

means for programmably dividing a predetermined portion of the heart rate spectrum into a plurality of contiguous, successive regions of progressively higher rate ranges, each region representing a respective class of ventricular tachyarrhythmia,

means for detecting anywhere within the predetermined portion of the heart rate spectrum a tachyarrhythmia of a patient'"'"'s heart,

means responsive to the detected tachyarrhythmia for automatically delivering a preselected therapy regimen comprising electrical stimuli, adapted to be applied to the ventricles of the patient'"'"'s heart, according to the respective class of the detected tachyarrhythmia, the delivered regimen differing from at least some of a plurality of available preselected therapy regimens respectively assigned to others of said regions for application to the patient'"'"'s heart in response to tachyarrhythmias detected in said other regions.

50. The device according to claim 49, wherein said dividing means includes means for selectively partitioning said heart rate spectrum into at least two contiguous regions with rate ranges representing ventricular tachycardias and with variable rate boundaries therebetween, in which the progressively higher rate ranges thereof are indicative of the degree of hemodynamic tolerance of the patient to heart rates within those regions, ranging from well tolerated in the lowest to poorly tolerated in the highest of said at least two regions.

51. The device according to claim 49, wherein said detecting means includes

means representing a plurality of algorithms for detecting tacharrhythmias in said regions, and

means for selecting from among said represented algorithms the algorithms which are to be used for detecting tachyarrhythmias in respective ones of said regions.

52. The device according to claim 49, wherein said therapy regimen delivering means includes

means for selecting one or more individual therapies in any of a multiplicity of different sequences for said delivery, each sequence defining a therapy regimen differing from the therapy regimens defined by others of said different sequences, and

means for selectively altering the characteristics of each therapy according to the particular treatment to be applied thereby within the delivered therapy regimen toward arresting the tachyarrhythmia and returning the heart rate to that within the rate range considered normal for the particular patient.

53. The device according to claim 52, wherein said selectively altering means includes

means for altering any therapy consisting of either cardioverting shocks or defibrillating shocks by any of the features in the group consisting of (i) the number of shocks to be delivered, (ii) the delay time interval between detection of the cardiac event and delivery of the shock, (iii) the amplitude of the shocks on the first attempt and each succeeding attempt to arrest the tachyarrhythmia, and (iv) the phasic structure of the shock waveform including pulse width, polarity, presence and absence of each phase.

54. The device according to claim 52, wherein the selectively altering means includes

means for altering any pacing therapy by any of the features in the group consisting of (i) the number of attempts to arrest the detected tachyarrhythmia, (ii) the number of pulses in the burst of pacing stimuli, (iii) the delay time interval between detection and the initial pulse in the burst of pacing stimuli, (iv) the interval between pulses in a burst of pacing stimuli, (v) the automatic decrementing or alternate incrementing and decrementing of either of said delay time interval or said interval between pulses, (vi) the variation of each of said intervals as a percentage of the tachyarrhythmia rate, (vii) the amount by which each of said intervals is increased or decreased for each successive burst, and the number of such increases and decreases, and (viii) the number of times any of the sequences defined by (v), (vi) and (vii) are to be repeated.

55. The device according to claim 49, wherein said therapy regimen delivering means includes

means for selectively assembling any of a multiplicity of different therapy regimens each including one or more therapies in the form of electrical stimuli from the group consisting of (i) bursts of electrical pacing stimuli of varying degrees of aggressiveness based on the vigorousness of the stimulation applied to the heart, (ii) electrical cardioverting shocks of greater intensity than electrical pacing stimuli but less than or equal energy content relative to electrical defibrillating shocks, and (iii) electrical defibrillating shocks;

wherein the progression of therapies from the least aggressive pacing burst, to the more aggressive and the most aggressive pacing bursts, to cardioverting shocks, to defibrillating shocks, defines the progression of therapies from the least to the most aggressive.

56. The device according to claim 55, further including

means for applying electrical pacing stimuli to the patient'"'"'s heart in response to either bradycardia or absence of a heart beat following delivery of a defibrillating shock to the heart.

57. The device according to claim 55, wherein said therapy regimen delivering means further includes

means responsive to continuing detection of the tachyarrhythmia beyond a predetermined number of cardiac cycles for automatically delivering a therapy regimen more aggressive than that delivered prior to the commencement of said predetermined number of cardiac cycles, but within the plurality of therapy regimens assigned to the region within which the rate of the detected tachyarrhythmia lies.

58. The device according to claim 55, wherein said therapy regimen delivering means further includes

means for preselecting the response of the therapy regimen delivering means to a transition of the detected tachyarrhythmia to a new region, comprising promptly halting the therapy regimen under delivery at or prior to the transition and commencing delivery of the least aggressive therapy regimen assigned to the new region.

59. The device according to claim 58, wherein said therapy regimen delivering means further includes

means responsive to rate acceleration of the tachyarrhythmia for automatically delivering a therapy regimen at least as aggressive as that delivered prior to the latest rate acceleration, but within the plurality of therapy regimens assigned to the region whose rate range encompasses the then-current rate of the tachyarrhythmia.

60. The device according to claim 59, wherein the preselected response of said preselecting means further includes, if the tachyarrhythmia thereafter continues at a rate in the new region, following with delivery of the next more aggressive therapy regimen assigned to the new region.

61. The device according to claim 49, further including

means for programming said device to permit patient activated capture test, and interrogation of elective replacement status and end of service status.

62. The device according to claim 49, wherein said therapy regimen delivering means includes

means for generating high voltage levels suitable for delivery of cardioverting shocks and defibrillating shocks to the patient'"'"'s heart.

63. The device according to claim 62, wherein said high voltage generating means includes

high voltage capacitors,

a high voltage oscillator, and

isolation means coupling said oscillator to said capacitors for charging thereof to respective ones of said high voltage levels of cardioverting shocks and defibrillating shocks.

64. The device according to claim 63, wherein

said high voltage generating means further includes

output circuit means for delivering said high voltage shocks to the patient'"'"'s heart, and

switch means operable to apply the high voltages on said capacitors as pulses of desired amplitude and polarity to said output circuit means;

and wherein said device further includes

control means for selectively operating said switch means.

65. The device according to claim 64, wherein said high voltage generating means further includes

short circuit protection means for opening said output circuit means in response to current flow exceeding a predetermined level in said output circuit means.