Programmable digital cardiac pacer

• US 4,388,927 A
• Filed: 12/13/1979
• Issued: 06/21/1983
• Est. Priority Date: 12/13/1979
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: American Hospital Supply Corp. (Baxter International Inc.)
• Inventors: Schober, Robert C.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/103,401
• Time in Patent Office: 1,286 Days
• Field of Search: 128/419 PG, 128/419 PT
• US Class Current: 607/5
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/346 Analysis of electrocardiograms
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions

Abstract

A cardiac pacer has separate digital filter circuits for sensing atrial and ventricular activity. Parameter data stored in memory is used by the digital filters for identifying the various components of cardiac activity, such as the P, R and T waves, as well as for identifying Premature Ventricular Contractions (PVC). A Ventricular Rate Time Out period is established from the last natural beat or stimulating pulse; and if a P wave or natural R wave is not sensed during that period, the system generates a stimulating pulse and, using T wave parameters in the ventricular filter, tests to verify capture. Loss of capture increases stimulating pulse width and amplitude to regain capture. If a P wave is sensed before the Rate Time Out period ends, the system establishes a predetermined P-R interval period to override the Ventricular Rate Time Out period in which the ventricular filter is set to detect a natural R wave in an effort to synchronize the ventricle with the atrium. Prior to the Ventricular Rate Time Out period of each cardiac cycle, the ventricular filter is set to detect Premature Ventricular Contractions. If a predetermined number of PVCs is detected, the system generates a train of stimulating signals at a rate higher than expected tachycardia in an effort to break the tachycardia cycle. Many of the system'"'"'s functions can be enabled or disabled by action of the physician; and many of the system parameters can be externally programmed, such as ventricular rate, stimulating pulse amplitude and/or duration, atrial and ventricular filter parameters, P-R delay interval and others.

Claims

1. Implantable cardiac pacing apparatus comprising:

electrode means adapted to couple a stimulating signal to the heart and for sensing a cardiac signal;

sensing means for sensing signals on said electrode means;

selection circuit means responsive to the signals sensed by said sensing means for detecting a predetermined component of a natural cardiac cycle;

first timing circuit means having a first timing source operating at a first rate for generating timing signals representative of time periods in a cardiac cycle including a rate time out period during which said predetermined component is expected to occur;

second timing circuit means synchronized with said first timing circuit means and having a second timing source independent of said first timing source and operating at a second, faster rate for generating a rate limit enable signal defining a predetermined mimimum period relative to the commencement of a cardiac cycle and ending during a normal cardiac rate time out period; and

generator means for generating a stimulating signal on said electrode means if said selection circuit means fails to detect said predetermined component during said rate time out period and being inhibited from generating said stimulating signal until said rate limit signal is generated by said second timing circuit means.

2. The apparatus of claim 1 wherein said first timing source comprises a crystal oscillator and wherein said generator means generates a stimulating pulse having its width defined by said crystal oscillator.

3. The apparatus of claim 2 wherein said apparatus includes a battery and wherein said second timing source includes a voltage-controlled oscillator energized by said battery and generating said rate limit enable signal at a period dependent upon the terminal voltage of said battery.

4. The apparatus of claim 3 wherein said rate limit enable signal occurs before the end of said rate time out period if said crystal oscillator is functioning properly and the terminal voltage of said battery has not depleted beyond a predetermined limit;

said apparatus further comprising rate limit processing circuit means for detecting when said rate limit signal fails to occur before the end of said rate time out period, each such detection comprising a rate limit event, said rate limit processing circuit means including counter circuit means for counting such rate limit events in successive occurrence and being responsive to a first predetermined number of such rate limit events for increasing said rate time out period of said first timing circuit means.

5. The apparatus of claim 4 wherein said rate limit processing circuit means is further responsive to a second predetermined number of such rate limit events following said first predetermined number of such events for causing said generator means to generate stimulating signals at a fixed rate, and wherein said second timing source derives said timing signals for said generator means and defines the duration of said stimulating signal.

6. The apparatus of claim 5 wherein said rate limit processing circuit means is responsive to a predetermined number of such events occurring in sequence prior to increase in said rate time out period.

7. The apparatus of claim 4 wherein said rate limit processing circuit means is further responsive to said predetermined number of rate limit events for increasing the duration of a stimulating signal when such predetermined number of rate limit events is detected.

8. The apparatus of claim 4 further comprising circuit means responsive to the application of an external magnet for substituting said second timing circuit means for said first timing circuit means to define said rate time out period and for shortening said period thereby increasing the rate of the system in an attempt to artificially stimulate the heart.

9. The apparatus of claim 8 wherein said circuit means responsive to the application of an external magnet further defines the duration of a stimulating pulse during such application using said first timing circuit means.

10. The apparatus of claim 8 further comprising memory means for storing data words representative of predetermined times in a cardiac cycle, including times for the beginning and end of said rate time out period;

comparison circuit means for comparing timing signals derived from said first timing means representative of lapsed time in a given cardiac cycle with data words from said storage means; and

state controller circuit means for coupling data words from said memory means to said comparison means, said rate limit processing circuit means being responsive to the application of an external magnet for overriding said state controller circuit means for coupling a predetermined data word from said signal storage means to said comparison means to define the end of said rate time out period during the application of said external magnet.

11. The apparatus of claim 10 wherein said predetermined word selected by said rate limit processing circuit determines the time out period for said second timing circuit means, said rate limit processing circuit means using said second timing circuit means to determine the rate time out period.

12. The apparatus of claim 11 wherein said word from said memory means selected by the application of said external magnet is of a duration to interrupt tachycardia, said rate limit processing circuitry further including counter circuit means for counting the number of pulses from said pulse generator means at said tachycardia rate and for limiting the number of pulses applied thereby to a predetermined number.

13. In cardiac pacing apparatus, the combination comprising:

first oscillator circuit means for generating a periodic signal at a first repetition rate;

first divider circuit means responsive to the output signal of said first oscillator circuit means for generating a digital signal representative of lapsed time;

first memory circuit means having a plurality of selectively addressable storage locations for storing digital words representative of sequentially occurring predetermined time marks relative to a commencement time;

first address means for addressing the storage locations of said first memory circuit means to enable selective readout of the time mark words stored therein;

first digital comparator circuit means responsive to one of said time mark words read out from said first memory means selected by said first address means representative of a predetermined time in a cardiac cycle for comparing the same with the contents of said first divider circuit means representative of lapsed time in a cardiac cycle;

said first digital comparator circuit means generating an output signal when said lapsed time signal contents of said first divider circuit means is equal to a time mark word read out from said first memory circuit means;

said output signal being representative of the occurrence of a predetermined time in said cardiac cycle as represented by said digital time mark word read out from said first memory circuit means.

14. The apparatus of claim 13 wherein said time mark words stored in said first memory means represent predetermined lapsed times relative to a reset signal and include digital words representative respectively of the end of a ventricular refractory period following detection of a natural R wave or stimulated cardiac signal, the end of a PVC time period, and the end of a Ventricular Rate Time Out period.

15. The apparatus of claim 13 wherein one of said time mark words stored in said first memory circuit means represents the end of a Ventricular Rate Time Out period during which a natural heart-beat is expected to occur;

and further comprising;

second oscillator circuit means operating independently of said first oscillator circuit means for generating a second periodic signal

second divider circuit means responsive to the output signal of said second oscillator circuit means for generating digital signal representative of lapsed time;

second memory circuit means having a plurality of selectively addressable storage locations, at least one of said storage locations storing a digital time word representative of a lapsed time defining a predetermined ventricular rate;

second address means for selectively addressing the storage locations of said second memory circuit means;

second digital comparator circuit means responsive to a digital time word read out of said second memory circuit means and to the contents of said second divider circuit means for generating a rate limit signal when the contents of said divider circuit means represenative of lapsed time equal the digital time word read out from said second memory circuit means;

pulse generator means for generating a stimulating pulse and coupling the same to the heart of a patient when actuated;

controller circuit means responsive to the output of said first comparator circuit means representative of the end of said Ventricular Rate Time Out period for actuating said pulse generator means; and

enable circuit means for inhibiting the actuation of said pulse generator means until said rate limit signal is generated by said second comparator circuit means,

whereby said first oscillator circuit means defines a cardiac cycle rate during normal operation, and said second oscillator circuit means prevents run away of said first oscillator circuit means.

16. The apparatus of claim 15 further comprising means responsive to the occurrence of said signal repesentative of the end of a Ventricular Rate Time Out period prior to the occurance of said rate limit signal a predetermined number of times for disabling said first oscillator circuit means and for enabling said second oscillator circuit means to provide timing signals for said pacing apparatus.

17. The apparatus of claim 16 wherein said first oscillator circuit means is a crystal oscillator for deriving primary timing signals and said second oscillator circuit means is a voltage controlled oscillator for deriving secondary timing signals.

18. The apparatus of claim 17 wherein said occurrence of said end of a Ventricular Rate Time Out period prior to a rate limit signal defines a rate limit event and wherein said apparatus includes rate limit counter circuit means for counting successive occurrences of rate limit events, said apparatus being responsive to a first predetermined count in said rate limit counter circuit means for lengthening said Ventricular Rate Time Out Period by a predetermined amount.

19. The apparatus of claim 18 wherein said controller circuit means extends the end of said Ventricular Rate Time Out period by approximately twelve percent in response to the detection of rate limit events of said first count.

20. The apparartus to claim 19 further comprising circuit means for generating an elective replacement time signal when said controller circuit means detects said first predetermined number of rate limit events to signal battery depletion.

21. The apparatus to claim 18 wherein said controller circuit means is responsive to a second predetermined number of said rate limit events in said counter circuit means occurring in succession with said first predetermined count, said second predetermined count being greater than said second predetermined count, for disabling said first oscillator circuit means and for enabling said second oscillator circuit means to provide timing signals to said apparatus.

22. The apparatus of claim 15 further comprising rate limit synchronizer circuit means for sychronizing the output signals of said first and second comparator circuit means.

23. In cardiac pacing apparatus, including electrode means for stimulating the heart and for sensing a cardiac signal;

detector circuit means responsive to the signal on said electrode means for detecting a predetermined component of a cardiac signal in response thereto;

timing circuit means responsive to the output of said detection circuit means for generating signals representative of a predetermined ventricular rate time out period during which a natural R wave is expected to occur in a normal cardiac cycle;

pulse generator circuit means responsive to said timing circuit means for generating a stimulating signal and for coupled the same to said electrode means to stimulate the heart in the absence of a detected R wave during said ventricular rate time out period;

the improvement comprising;

a plurality of function circuit means each performing a predetermined cardiac function in said apparatus;

status control memory means for storing a plurality of status control data words, each word representative of a desired status condition for an associated function circuit means; and

state controller means responsive to the contents of said status control memory means for selectively enabling or disabling the operation and functioning of each of said function circuit means in response to an associated status data word in said status control memory means.

24. The apparatus of claim 23 wherein one of said function circuit comprises capture verification circuit means including sensing means for determining whether the ventricle has contracted in response to a stimulating signal and for generating a verification signal in response thereto;

said status control memory circuit means storing a digital signal representative of whether said capture verification circuit means is to be enabled or disabled;

said state controller means selectively enabling or disabling said capture verification circuit means in response to the contents of said status control memory circuit means.

25. The apparatus of claim 23 wherein one of said function circuit means comprises automatic tachycardia overdrive circuit means responsive to said timing circuit means for detecting whether a patient is in a state of tachycardia and for generating predetermined signals to stimulate said heart in an attempt to overcome said state of tachycardia;

said status control memory means storing digital signals representative of whether said automatic tachycardia overdrive circuit means is to be enabled or disabled;

said state controller means selectively enabling or disabling said overdrive circuit means in response to the contents of said status control memory circuit means.

26. The apparatus of claim 23 wherein said pacing apparatus is adapted for total implantation in a patient and wherein one of said function circuit means includes means responsive to the application of an external signal for permitting an external source to control the generation of a stimulating signal of predetermined repetition rate for application to said electrode means;

and means responsive to said external signal for permitting said external source of stimulating pulses to override said timing circuit means and said pulse generator means implanted in said patient, said status control memory means storing data for controlling said pacing apparatus to be responsive to said external signal or nonresponsive thereto.

27. The apparatus of claim 23 wherein said apparatus is adapted for implantion in a patient, and said timing circuit means generates signals for defining a ventricular rate time out period during which a natural R wave is expected to occur;

and wherein one of said function circuit means includes means responsive to the occurrence of a P wave in said patient during said ventricular rate time out period prior to an R wave for establishing a predetermined P-R interval after the detection of such P wave at the end of which interval said ventricular rate time out period terminates irrespective of the time remaining in said ventricular rate time out period when said P wave was detected, said status control memory means storing digital signals representative of whether said function circuit means is operative.

28. The apparatus of claim 23 wherein said apparatus is adapted for implantation in a patient;

said apparatus further comprising switch means in said implanted apparatus responsive to the application of an external signal for communicating said implanted apparatus with an external source of signals;

first circuit means in said implanted apparatus responsive to the state of said switch means for generating a signal representative thereof;

inverter circuit means responsive to the output signal of said first circuit means for inverting the sense thereof;

said status control memory means storing signals representative of the operativeness of said inverter circuit means; and

state control circuit means being responsive to the signals stored in said status control memory means for selectively including or overriding said inverter circuit means whereby the signals stored in status control memory means determine whether the state of said switch means is true or inverted.

29. The apparatus of claim 23 wherein said apparatus is adapted to be implanted in a patient, and further comprising:

switch means responsive to the application of an external signal for generating an internal control signal representative of whether said external signal is present or not; and

one of said function circuit means is responsive to said internal control signal for forcing said pulse generator means to generate a stimulating signal at a predetermined fixed rate when said internal control signal is present;

said status control memory means storing signals representative of a state of enablement or disablement for said function circuit means, said state controller circuit means being responsive to said signals stored in said status control memory for selectively enabling or disabling said one of function circuit means.

30. The apparatus of claim 23 wherein said timing circuit means includes first oscillator circuit means;

and further comprising;

counter circuit responsive to the output of said fist oscillator circuit means for generating a signal representative of lapsed time;

time mark memory means for storing data words representative of predetermined ventricular rate time out periods in a cardiac cycle;

comparator circuit means responsive to the contents of said counter circuit means and a ventricular rate time out data word from said time mark memory means for generating an output signal when the same are equal;

state controller circuit means responsive to the output signal of said comparator circuit means representative of a selected ventricular rate time out time for causing said pulse generator circuit means to generate a stimulating signal if said detector circuit means had not detected an R wave prior thereto;

means responsive to the application of an external signal for generating an internal signal in said apparatus;

said state controller means being responsive to said internal signal for selecting a predetermined rate time out data word from said time mark memory means representative of a safe pacing condition.

31. The apparatus of claim 23 wherein said timing circuit means comprises a primary oscillator for generating clock signals for said apparatus and wherein said status control memory means stores a standby data word having a first and a second state, said apparatus being responsive to said first state for inhibiting the transmission of said clock signals for the remainder of said apparatus and being responsive to said second state for permitting said clock signals to be transmitted to the remaining circuitry of said apparatus, whereby when said stored signal is in said first state, power is fed to said oscillator but the remaining circuitry is not clocked, thereby conserving battery power in a standby mode;

said apparatus being responsive to an externally applied signal to change the state of said standby word from said first state to said second state.