Cardiac stimulator and defibrillator with means for identifying cardiac rhythm disorder and chamber of origin

• US 6,076,014 A
• Filed: 08/01/1997
• Issued: 06/13/2000
• Est. Priority Date: 08/01/1997
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc), Sulzer Intermedics, Inc. (Sulzer AG)
• Original Assignee: Sulzer Intermedics, Inc. (Sulzer AG)
• Inventors: Alt, Eckhard
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US08/904,851
• Time in Patent Office: 1,047 Days
• Field of Search: 607/4, 607/5
• US Class Current: 607/4
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

A medical interventional device is structured for implantation in a human patient, to respond to detection of cardiac activity of the patient indicative of cardiac dysrhythmias. The device includes a cardiac therapy system responsive to a detected arrhythmia in either the atrial or ventricular chambers for automatic therapeutic treatment by selective application of an appropriate therapy regimen consisting of pacing, cardioverting or defibrillating waveforms of predetermined type and energy content to the chamber diagnosed as that in which the dysrhythmia originated. The device incorporates a DDD or DDD-R pacemaker for dual chamber sensing of electrical (ECG) activity, and for constant pacing of the atrium and atrioventricular synchronization. A fuzzy logic subsystem is used for diagnosis including identification of the originating heart chamber. The electrode system for delivering the selected therapy regimen includes a single lead for pacing, sensing, cardioversion and defibrillation associated with each of the right atrial and ventricular chambers. A counter-electrode for defibrillation may be the metal case in which the device electronics are housed, or a cardiac electrode implanted in the left pulmonary artery or the distal coronary sinus.

Claims

1. An implantable medical interventional device having means for selectively supplying a plurality of therapeutic regimens to alleviate various ones of a plurality of cardiac rhythm disorders, including ventricular defibrillator means responsive to ventricular fibrillation of a patient'"'"'s heart for defibrillating the ventricles of the heart, and an improvement to enhance recognition, discrimination and therapeutic treatment of cardiac rhythm disorders, said improvement comprising:

artificial pacing means for pacing the patient'"'"'s heart including continuous sensing and responsive pacing of cardiac activity of both the atrial and ventricular chambers for monitoring the status of cardiac activity of the atrial and ventricular chambers and for maintaining atrioventricular synchrony of the patient'"'"'s heart, and

evaluation means operatively combining the artificial pacing means and the ventricular defibrillator means, for determining the existence of a particular rhythm disorder to identify and treat said particular rhythm disorder, said evaluation means including logic means responsive to signals developed by said atrial and ventricular sensing for comparing the atrial and ventricular signals to diagnose when the comparison is indicative of a cardiac rhythm disorder being experienced by the patient and based on said indication to prescribe an appropriate one of said plurality of therapeutic regimens to alleviate the diagnosed rhythm disorder.

2. The device of claim 1, wherein said pacing means includes:

a pulse generator for generating pulses at a predetermined adequate rate,

detection means for detecting a parameter indicative of a physiological need of the patient for pacing at an atrial rate different from said predetermined adequate rate and producing a signal indicative of such physiological need, and

pulse rate varying means responsive to said signal indicative of physiological need for controllably varying the rate at which pulses are generated by said pulse generator to adapt the paced atrial rate to a rate for satisfying said physiological need.

3. The device of claim 1, including:

a metal case housing at least a portion of the device for subcutaneous implantation in the patient'"'"'s left chest area, said case constituting an electrode of the device for use in defibrillation.

4. The device of claim 1, including atrial defibrillator means having shock producing means responsive to detection of atrial fibrillation for applying a defibrillating shock to the atrium and, in conjunction with said artificial pacing means, to return the atrial rate to a predetermined adequate rate synchronized with the ventricular rate.

5. The device of claim 4, including:

electrical connector means for accepting a single atrial lead for atrial sensing, pacing, and defibrillation, and a single ventricular lead for ventricular sensing, pacing, and defibrillation.

6. The device of claim 5, including:

a single atrial lead and a single ventricular lead, each including at least a portion composed of an electrically conductive material of low polarization to permit detection of intrinsic rhythm in a respective chamber of the patient'"'"'s heart despite presence of otherwise interfering polarization current on a respective one of said atrial and ventricular leads.

7. The device of claim 6, wherein said electrically conductive material is carbon.

8. The device of claim 6, wherein said electrically conductive material is carbon fiber.

9. An implantable medical interventional device having means for selectively supplying a plurality of therapeutic regimens to alleviate various ones of a plurality of cardiac rhythm disorders, including ventricular defibrillator means responsive to ventricular fibrillation of a patient'"'"'s heart for use in defibrillating the ventricles of the heart, and an improvement to enhance recognition, discrimination and therapeutic treatment of cardiac rhythm disorders, said improvement comprising:

artificial pacing means for pacing the patient'"'"'s heart including continuous sensing and responsive pacing of cardiac activity of both the atrial and ventricular chambers for monitoring the status of cardiac activity of the atrial as well as the ventricular chambers and for maintaining atrioventricular synchrony of the patient'"'"'s heart;

evaluation means operatively combining the artificial pacing means and the ventricular defibrillator means, for determining the existence of a particular rhythm disorder to identify and treat the indicated rhythm disorder, said evaluation means including means for diagnosing an apparent atrial rhythm disorder from an atrial sensing signal; and

detecting means for detecting the status of a physiological parameter of the patient other than ECG to verify or reject a diagnosis of atrial rhythm disorder by the diagnosing means from the atrial sensing signal.

10. The device of claim 9, wherein:

said detecting means comprises an accelerometer for detecting patient movement or position.

11. An implantable medical interventional device having means for selectively supplying a plurality of therapeutic regimens to alleviate various ones of a plurality of cardiac rhythm disorders, including ventricular defibrillator means responsive to ventricular fibrillation of a patient'"'"'s heart for use in defibrillating the ventricles of the heart, and an improvement to enhance recognition, discrimination and therapeutic treatment of cardiac rhythm disorders, said improvement comprising:

artificial pacing means for pacing the patient'"'"'s heart including continuous sensing and responsive pacing of cardiac activity of both the atrial and ventricular chambers for monitoring the status of cardiac activity of the atrial as well as the ventricular chambers and for maintaining atrioventricular synchrony of the patient'"'"'s heart, and

evaluation means operatively combining the artificial pacing means and the ventricular defibrillator means for developing generalized findings indicative of the existence of a particular rhythm disorder to identify and treat the indicated rhythm disorder, said evaluation means comprising fuzzy logic including means for discriminating between detected atrial and ventricular rhythm disorders to identify the heart chamber in which a detected disorder originates, and means for selecting a pacing, cardioverting or defibrillating therapy for delivery to the identified heart chamber.

12. An implantable medical interventional device having means for selectively supplying a plurality of therapeutic regimens to alleviate various ones of a plurality of cardiac rhythm disorders, including ventricular defibrillator means responsive to ventricular fibrillation of a patient'"'"'s heart for use in defibrillating the ventricles of the heart, and an improvement to enhance recognition, discrimination and therapeutic treatment of cardiac rhythm disorders, said improvement comprising:

artificial pacing means for pacing the patient'"'"'s heart including continuous sensing and responsive pacing of cardiac activity of both the atrial and ventricular chambers for monitoring the status of cardiac activity of the atrial as well as the ventricular chambers and for maintaining atrioventricular synchrony of the patient'"'"'s heart,

atrial defibrillator means responsive to the monitored status of the atrium as being indicative of atrial fibrillation for generating electrical therapy to defibrillate the atria,

evaluation means operatively combining, the artificial pacing means, the atrial defibrillator means and the ventricular defibrillator means, for developing generalized findings indicative of the existence of a particular rhythm disorder to identify and treat the indicated rhythm disorder, and

electrical connector means for accepting a single atrial lead for atrial sensing, pacing, and defibrillation, and a single ventricular lead for ventricular sensing, pacing, and defibrillation, said single atrial lead including a first defibrillating electrode adapted to be positioned in the right atrium and a second defibrillating electrode adapted to be positioned in the left pulmonary artery or the distal coronary sinus, when said atrial lead is implanted in the patient'"'"'s heart.

13. An interventional medical device structured and adapted for implantation into a patient to diagnose cardiac rhythm disorders and selectively deliver any of a plurality of electrical waveform therapies to treat a sensed disorder, the device comprising:

ventricular therapy means for sensing and treating ventricular rhythm disorders, and

atrial therapy means for sensing and treating atrial rhythm disorders, and including means to synchronize atrial and ventricular beats when atrial rhythm disorders are not present;

the ventricular therapy means and the atrial therapy means including

means for defibrillating the respective ventricular and atrial chambers,

ECG data storage means, and

fuzzy logic means for comparing current ECG parameters with stored ECG parameters for enhancing the diagnosis to provide more precise rhythm disorder recognition and classification.

14. The device of claim 13, including:

means for separating atrial and ventricular ECG signals into attributes including amplitude of the ECG signal, amplitude relative to stored ECG signals, variation of ECG signal amplitudes, cycle length, variation of cycle length, morphology of ECG signal, and vector of an intracardiac ECG.

15. The device of claim 13, including:

a metal case for housing device components and for use as a defibrillation electrode.

16. A method of treating a plurality of cardiac rhythm disorders with a single medical interventional device implanted in a human patient, including the device-implemented steps of:

sensing both atrial and ventricular rhythm disorders of the patient'"'"'s heart and responding with automatic therapeutic treatment from the device by application to a heart chamber of an appropriate therapy regimen selected from pacing, cardioverting and defibrillating electrical waveforms of predetermined type and energy content, and

selecting the appropriate therapy regimen and the heart chamber to which it should be applied by evaluating atrial and ventricular ECG signals to develop therefrom generalized findings indicative of existence of a specific rhythm disorder and, from the generalized findings, to identify whether a specific ventricular rhythm disorder originated in the atrium or the ventricle.

17. The method of claim 16, further including:

pacing the atrium at a selected rate except when a sensed disorder requires a different therapy regimen to be applied to the atrium.

18. The method of claim 17, further including:

detecting patient physical activity and responding thereto by adjusting the pacing rate of both atrium and ventricle to satisfy the physiological need of the patient for a faster rate during the physical activity.

19. The method of claim 18, further including:

using the detection of patient physical activity to confirm or to reject the indication of specific rhythm disorder from the evaluation.

20. A method of treating a plurality of cardiac rhythm disorders with a single medical interventional device implanted in a human patient, including the device-implemented steps of:

sensing both atrial and ventricular rhythm disorders of the patient'"'"'s heart and responding with automatic therapeutic treatment from the device by application to a heart chamber of an appropriate therapy regimen selected from pacing cardioverting and defibrillating electrical waveforms of predetermined type and energy content, and

selecting the appropriate therapy regimen and the heart chamber to which it should be applied by evaluating atrial and ventricular ECG signals to develop therefrom generalized findings indicative of existence of a specific rhythm disorder and, from the generalized findings, to identify the heart chamber in which the specific rhythm disorder originated, including performing the step of evaluating the atrial and ventricular ECG signals by applying a fuzzy logic comparison of current ECG parameters with stored ECG parameters for enhanced recognition and classification of rhythm disorders.

21. An implantable defibrillator device, comprising:

a DDD-R mode pacemaker having electrode means for continuously sensing and pacing atrial and ventricular chambers to maintain AV synchrony, and sensor means to generate a rate adaptive pacing signal to vary stimulation rate of a patient'"'"'s heart according to the patient'"'"'s need,

defibrillator means in combination with said pacemaker, for treating arrhythmias including fibrillation; and

evaluation means operatively combining said DDD-R pacemaker and said defibrillator means for developing generalized findings indicative of the apparent presence of a specific arrhythmia of the atrial or ventricular chamber from sensed signals therefrom by which to assess appropriate treatment therapy for the indicated arrhythmia.

22. The implantable defibrillator device of claim 21, wherein said pacemaker includes means for limiting ventricular rate response of the heart to avoid an excessively high ventricular rate attributable to an atrial arrhythmia.

23. The device of claim 21, wherein said sensor means is an accelerometer.

24. The device of claim 23, wherein said device is encompassed in a metallic housing, and said accelerometer is isolated from said metallic housing.

25. An implantable medical interventional device having means for selectively supplying a plurality of therapeutic regimens to alleviate various ones of a plurality of cardiac rhythm disorders, including ventricular defibrillator means responsive to ventricular fibrillation of a patient'"'"'s heart for use in defibrillating the ventricles of the heart, and an improvement to enhance recognition, discrimination and therapeutic treatment of cardiac rhythm disorders, said improvement comprising:

artificial pacing means for pacing the patient'"'"'s heart including continuous sensing and responsive pacing of cardiac activity of both the atrial and ventricular chambers for monitoring the status of cardiac activity of the atrial as well as the ventricular chambers and for maintaining atrioventricular synchrony of the patient'"'"'s heart, said artificial pacing means including atrial sensing means for sensing electrical activity of the atrium of the patient'"'"'s heart to produce a signal representative of the atrial activity and ventricular sensing means for sensing ventricular electrical activity of the patient'"'"'s heart to produce a signal representative of the ventricular activity, and pacing generator means for stimulating the atrium at a predetermined adequate rate;

said pacing generator means including a pulse generator for generating pulses at said predetermined adequate rate, detection means for detecting a parameter indicative of a physiological need of the patient for pacing at an atrial rate different from said predetermined adequate rate and producing a signal indicative of such physiological need, and pulse rate varying means responsive to said signal indicative of physiological need for controllably varying the rate at which pulses are generated by the pulse generator to adapt the paced atrial rate to a rate for satisfying said physiological need; and

evaluation means operatively combining the artificial pacing means and the ventricular defibrillator means, for developing generalized findings indicative of the existence of a particular rhythm disorder to identify and treat the indicated rhythm disorder, said evaluation means including logic means responsive to the atrial and ventricular sensing means signals for comparing the atrial rate to the ventricular rate to diagnose when the comparison is indicative of a cardiac rhythm disorder being experienced by the patient and based thereon to prescribe an appropriate one of said plurality of therapeutic regimens to alleviate the diagnosed cardiac rhythm disorder.