Implantable medical interventional device

• US 5,342,404 A
• Filed: 04/03/1992
• Issued: 08/30/1994
• Est. Priority Date: 04/03/1992
• Status: Expired due to Term

• Current Assignee: Advanced Medical Optics Incorporated (Johnson & Johnson)
• Original Assignee: Intermedics Incorporated (Boston Scientific Corporation)
• Inventors: Mestre, Edgar, Matula, Marcus, Alt, Eckhard
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US07/863,092
• Time in Patent Office: 879 Days
• Field of Search: 128/782, 607/6, 607/14, 607/18, 607/19
• US Class Current: 607/6
• 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 responds to detection of cardiac activity of the patient indicative of ventricular tachycardia (VT) or fibrillation (VF) by successively applying to the patient'"'"'s heart selected ones of different electrical waveforms for treatment to break the VT or VF, respectively, until the monitored cardiac activity indicates that the treatment has been successful. An accelerometer adapted to sense position and movement of the patient along three mutually orthogonal axes acts as an activity status sensor to detect physical activity and inactivity of the patient to complement the detection of the patient'"'"'s cardiac activity for confirming that a detected VT is a pathologic tachycardia rather than a physiologic tachycardia, and in response to such confirmation the device selects an appropriate electrical waveform for the treatment. The device is capable of recognizing from detected physical activity the occurrence of a sudden vigorous movement associated with a syncope by calculating variances relative to the mean of the detected physical activity, and of responding to such recognition by selecting a defibrillating waveform for immediate application to the patient'"'"'s heart. A scoring system based on assigned weightings of subparameters of detected cardiac activity and detected physical activity or inactivity is used to determine the likelihood that a physiologic tachycardia, a pathologic tachycardia, or fibrillation is being detected.

Claims

1. An implantable medical interventional device for treatment of pathologic tachycardias, comprising:

first sensor means adapted to detect cardiac activity of the patient in which the interventional device is implanted for producing a first electrical signal representative of such cardiac activity including heart rate of the patient,

second sensor means adapted to detect movement and lack of movement indicative of physical activity and inactivity of the patient for producing a second electrical signal representative of the patient'"'"'s activity status,

generator means for selectively generating electrical waveforms to be applied to the patient'"'"'s heart to break a pathologic tachycardia, and

control means setting a predetermined heart rate and responsive to said first and second electrical signals as complementary criteria for distinguishing a heart rate of the patient exceeding the predetermined rate during a period of physical activity by the patient indicative of a pathologic tachycardia requiring treatment from a physiologic tachycardia attributable to patient activity, and including activation means responsive to a decision by said control means that the patient is experiencing a pathologic tachycardia for triggering said generator means to generate an electrical waveform having characteristics selected to break the tachycardia.

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

said first sensor means comprises a sensor for detecting and generating a signal representative of the patient'"'"'s ECG.

3. The implantable medical interventional device of claim 1, wherein:

said second sensor means comprises an accelerometer.

4. The implantable medical interventional device of claim 3, wherein:

the accelerometer comprises means to detect orientation and movement of the patient in three dimensions.

5. The implantable medical interventional device of claim 4, wherein said means to detect orientation and movement of the patient in three dimensions comprises:

first and second mercury ball sensors, each including a mercury ball and a multiplicity of spaced-apart electrodes in a plane over which the respective mercury ball may roll in response to movement of the patient for intermittently establishing electrical connections with various ones of the electrodes, and

said electrode planes of said first and second mercury ball sensors being orthogonally oriented relative to one another to enable detection of movement and orientation of the accelerometer along three different orthogonal axes.

6. The implantable medical interventional device of claim 5, wherein said control means further includes:

detection means responsive to electrical closures and openings of the spaced-apart electrodes in each of said first and second mercury ball sensors as the respective mercury ball makes and breaks electrical connections with various ones of said spaced-apart electrodes during rolling of the ball, and

distinction means for calculating the quotient of the standard deviation divided by the mean of the closures and openings over a predetermined interval of time to detect sudden brief movement by the patient consistent with a syncope for enhancing the decision by said control means that the patient is experiencing a pathologic tachycardia.

7. The implantable medical interventional device of claim 3, further including:

a case housing said device, and

means mechanically isolating said accelerometer from the case to render the accelerometer substantially unresponsive to pressure on the case.

8. The implantable medical interventional device of claim 1, wherein:

said second sensor means comprises integrated electronic circuit means responsive to orientation and movement thereof for producing said second electrical signal.

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

said integrated electronic circuit means is a silicon based mechanoelectrical converter.

10. The implantable medical interventional device of claim 9, wherein:

said mechanoelectrical converter is selected from the group consisting of piezoresistive, piezoelectric and piezocapacitive converters.

11. The implantable medical interventional device of claim 1, wherein:

said control means is further responsive to said complementary criteria for deciding whether the patient is experiencing ventricular fibrillation,

said generator means includes storage capacitor means for storing a level of electrical charge suitable for defibrillation of the patient'"'"'s heart, and

said activation means is responsive to a decision by said control means that the patient is experiencing ventricular fibrillation for causing said storage capacitor means to be charged to said level for delivery within said electrical waveform when the generator means is triggered by the activation means.

12. The implantable medical interventional device of claim 1, wherein said control means further includes:

calculating means responsive to said second electrical signal representative of the patient'"'"'s activity status for calculating the standard deviation relative to the mean of said second electrical signal over a predetermined time interval for enhancing discrimination of pathologic tachycardia from physiologic tachycardia by said control means.

13. In combination with an implantable defibrillator adapted to selectively deliver electrical waveform therapies to a patient'"'"'s heart in response to detection of cardiac activity indicative of ventricular tachycardia or fibrillation, the improvement comprising:

control means for discriminating between pathologic tachycardia and physiologic tachycardia during the patient'"'"'s engagement in physical activity, said control means including

implantable complementary sensor means for detecting movement indicative of physical activity of the patient,

computing means responsive to detected physical activity and confirming detected cardiac activity of the patient indicative of pathologic tachycardia for recognizing a sudden brief movement by the patient as syncope, and

generator means responsive to recognition of syncope by said computing means for generating a predetermined antitachycardia electrical waveform therapy to be delivered to the patient'"'"'s heart to revive the patient.

14. The improvement of claim 13, wherein:

said complementary sensor means includes means for producing an electrical signal in response to detecting movement indicative of physical activity of the patient, and

said computing means includes means for calculating the quotient of the standard deviation divided by the mean of variations of said electrical signal with the detected movement over time.

15. The improvement of claim 13, wherein:

said complementary sensor means comprises accelerometer means for sensing movement of the patient along three mutually orthogonal axes.

16. The improvement of claim 15, wherein the accelerometer means comprises:

a pair of orthogonally oriented mercury ball sensors each including spaced-apart planar electrodes and a mercury ball for contacting various ones of said spaced-apart electrodes to intermittently establish and disrupt electrical connections therewith over time and to establish particular electrical connections therewith at any given time upon positioning of the respective mercury ball in response to movements and static position of the patient.

17. A method of timing the delivery of antitachycardia and defibrillating electrical therapies to a patient'"'"'s heart from an automatic implanted defibrillator device, comprising the device-implemented steps of:

detecting the current status of the patient'"'"'s physical activity while simultaneously detecting the patient'"'"'s cardiac activity to recognize a ventricular tachycardia while the patient is engaged in physical activity,

determining the degree of probability that the recognized ventricular tachycardia is a pathologic tachycardia rather than a physiologic tachycardia by weighting the detected cardiac activity and the detected status of physical activity of the patient as separate indicia of the degree of probability that a pathologic tachycardia is occurring, and

delivering an antitachycardia electrical therapy to the patient'"'"'s heart when the weighting indicates a predetermined degree of probability that a pathologic tachycardia is occurring.

18. The method of claim 17, further including the device-implemented steps of:

detecting whether the antitachycardia electrical therapy delivered to the patient'"'"'s heart was effective to terminate the tachycardia, and, if not, whether the tachycardia is accelerating into ventricular fibrillation, and

delivering defibrillating electrical therapy to the patient'"'"'s heart if the previously delivered antitachycardia electrical therapy was ineffective to terminate the tachycardia coupled with detection of acceleration into ventricular fibrillation.

19. The method of claim 17, further including the device-implemented steps of:

monitoring the cardiac activity and the current status of physical activity or inactivity of the patient following the delivery of an antitachycardia electrical therapy to determine whether that delivered therapy succeeded in terminating the pathologic tachycardia, and

delivering another antitachycardia electrical therapy different from the last delivered therapy when the monitoring indicates that the last delivered therapy did not terminate the pathologic tachycardia.

20. The method of claim 19, wherein the step of delivering another antitachycardia electrical therapy includes:

selecting said another antitachycardia electrical therapy to be delivered from the group consisting of a single burst of stimulating pulses, plural bursts of stimulating pulses, a train of rapid stimulation pulses, a single low energy shock, plural low energy shocks, and a relatively higher energy shock, and

generating the selected another antitachycardia electrical therapy for delivery to the patient'"'"'s heart.

21. An implantable medical device for intervention in response to the implant patient experiencing a syncope, comprising:

first sensor means for detecting electrical cardiac activity of the patient and for producing a first electrical signal representative thereof,

second sensor means for detecting posture, position and physical activity of the patient and for producing a second electrical signal representative thereof,

discrimination means responsive to said first and second electrical signals for discriminating between a physiologic tachycardia and a pathologic tachycardia of the patient'"'"'s heart,

control means responsive to discrimination of a tachycardia by said discrimination means as a pathologic tachycardia for prescribing one among a plurality of different electrical therapy waveforms for treatment of the pathologic tachycardia, and

generator means responsive to the prescribing of one of said electrical therapy waveforms by said control means for generating the prescribed waveform for application to the patient'"'"'s heart,

said discrimination means including computing means responsive to said second electrical signal representative of detected physical activity of the patient by said second sensor means for recognizing therefrom the occurrence of a collapse of the patient associated with a syncope,

said control means including means responsive to said recognizing by said computing means for prescribing defibrillating waveform from among said plurality of electrical therapy waveforms for treatment of the syncope.

22. The implantable medical device of claim 21, wherein:

said computing means includes means responsive to said second electrical signal representative of detected physical activity of the patient by the second sensor means, and representative of detected changes of position of the patient having a mean value over a time interval and undergoing variances from the mean value, for calculating from said second electrical signal the variances relative to the mean value thereof to enhance recognition of a syncope event.

23. The implantable medical device of claim 22, wherein:

said second sensor means comprises accelerometer means for sensing movement of the patient along three mutually orthogonal axes.

24. The implantable medical device of claim 21, wherein:

said first electrical signal has a plurality of parameters associated with at least the patient'"'"'s heart rate and ECG,

said second electrical signal has a plurality of parameters associated with at least the patient'"'"'s posture, position and change thereof, and activity, and

said computing means includes tallying means responsive to said parameters of said first and second electrical signals for assigning predetermined weighted Values to said parameters according to the relative importance of each Of said parameters in assessing probability that a cardiac event including at least one of pathologic tachycardia and syncope is occurring based on detection by the respective sensor means, and for adding the weighted values of the parameters for determining from the total of said weighted values over a predetermined interval of time the likelihood that a syncope is occurring in that interval of time.

25. A method of determining when to apply any of a plurality of available antitachycardia therapies, including possible defibrillation therapy, to a patient'"'"'s heart from an implantable antitachycardia device, comprising the steps of:

providing said plurality of antitachycardia therapies,

detecting at least two different physiologic parameters of the patient from which hemodynamic events for treatment with said therapies are discernible, one of said parameters representing electrical cardiac activity of the patient,

processing the detected different physiologic parameters to obtain a variety of subparameters identifying characteristics of the respective detected different physiologic parameters from which said subparameters were obtained,

scoring each of the processed subparameters by assigning to it a relative value according to its importance in signifying the probability of occurrence of a predetermined hemodynamic event, and

adding the relative values of the processed subparameters to obtain a cumulative score, and selecting one of the provided plurality of anti-tachycardia therapies prescribed as best suited for treatment of the predetermined hemodynamic event when the cumulative score of the processed subparameters reaches a preestablished level of probability that said predetermined hemodynamic event is occurring.

26. The method of claim 25, including:

designating movement indicative of physical activity of the patient as another of the at least two different physiologic parameters to be detected.

27. The method of claim 26, wherein:

the step of processing the detected different physiologic parameters to obtain a variety of subparameters is performed to obtain subparameters including at least one of patient rest, patient exercise, patient position, and change of patient position for the parameter indicative of patient movement, and to obtain subparameters including at least one of absolute heart rate, absence of QRS complexes, relative heart rate change, heart rate stability, and ECG morphology for the parameter representative of cardiac activity.

28. A method of controlling the delivery of an appropriate therapy of an antitachycardia device configured and adapted to be implanted in a patient, which includes:

monitoring the posture, position and physical activity of the patient by use of at least two two-dimensional accelerometers carried by the patient to detect movement of the patient along three mutually orthogonal axes,

detecting the patient'"'"'s ECG,

processing the detected movement of the patient to obtain information on posture, position and physical activity of the patient, and processing the detected ECG of the patient to obtain information thereon,

using the information obtained from both detected movement and detected ECG and a comparison thereof to distinguish a physiologic tachycardia from a pathologic tachycardia of the patient'"'"'s heart, and, if a pathologic tachycardia is found, triggering the antitachycardia device to deliver a predetermined therapy therefrom predetermined as most appropriate to terminate the pathologic tachycardia.

29. A control device for controlling the therapeutic function of an antitachycardia device configured and adapted to be implanted in a patient, said control device including:

accelerometer means for detecting state of physical activity of the patient and at least one of posture and position of the patient, and

ECG means for detecting the ECG of the patient,

verification means for comparing the detected state of physical activity of the patient and said at least one of posture and position of the patient against the detected ECG of the patient to distinguish a physiologic tachycardia from a pathologic tachycardia of the patient'"'"'s heart, and

trigger means for actuating said antitachycardia device to apply a preselected antitachycardia therapy to the patient upon determination that the patient is experiencing a pathologic tachycardia.