Programmable demand pacer

• US 4,304,238 A
• Filed: 08/02/1979
• Issued: 12/08/1981
• Est. Priority Date: 09/16/1976
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Fischer, David J.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/062,924
• Time in Patent Office: 859 Days
• Field of Search: 128/419 PG
• US Class Current: 607/31
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals

Abstract

An implantable demand-inhibit type cardiac pacer for producing artificial stimulating pulses of a desired repetition rate and of a desired pulse width in the absence of normal R-wave activity in the patient'"'"'s heart. The pacer is implemented principally from integrated circuit digital logic components and includes programmable registers, which when addressed by an externally applied code word of a predetermined format, allows the pulse width as well as the pulse rate of the pacer pulses to be changed to different desired values. Also incorporated in the pacer of this invention is circuitry which allows testing of the implanted energy source so that a physician can readily determine whether the energy source has discharged to a point where replacement is indicated.

A dual refractory period for paced beats and normal beats is provided along with digital circuits for insuring proper operation even in the presence of extraneous noise signals. Furthermore, fail-safe circuitry is provided to insure that the patient'"'"'s heart will be properly stimulated even where, through a programming error, an unacceptable pacer pulse width or rate is entered into the programmable registers.

Claims

1. In an implantable heart pacer of the type including a variable rate pulse generator for applying artificial heart stimulating pulses at a desired rate of the heart of a patient in the absence of normal heart activity, means for changing the repetition rate of the pulses produced by said pulse generator from a first value to a second desired value, comprising:

(a) a register adapted to store a digital value corresponding to a desired pulse repetition rate;

(b) a digital counting means having inputs and outputs;

(c) magnetically actuable means responsive to the presence of an applied magnetic field for generating a code corresponding to a second desired pulse repetition rate;

(d) multiplexer means connected between said register, said magnetically actuable means and said inputs of said digital counting means for selectively transferring the contents of said register of said digital code corresponding to a second desired pulse repetition rate to said digital counting means; and

(e) means coupling said outputs of said digital counting means to said variable rate pulse generator.

2. Apparatus as in claim 1 and further including:

(a) a source of electrical potential for providing energization of said implantable heart pacer;

(b) circuit means coupled to said source of electrical potential for sensing the voltage output of said source; and

(c) means including said magnetically actuable means coupling said circuit means to said multiplexer for entering a predetermined binary code pattern into said digital counting means indicative of the voltage output of said source, the arrangement being such that the rate at which said heart stimulating pulses are produced when said externally applied magnetic field is present is indicative of the voltage output of said source.

3. An implantable heart pacer for applying artificial heart stimulating pulses at a desired pre-programmed rate to the heart of a patient in the absence of normal heart activity comprising in combination:

(a) variable rate pulse generator means having a resettable timing means determining a desired delay period between successive ones of said heart stimulating pulses; and

(b) a refractory period establishing means comprising;

(1) an N-stage binary counter having a reset terminal, a counter input terminal and a plurality of output terminals associated with predetermined stages of said N-stage counter;

(2) a source of regularly occuring clock signals;

(3) gating means connected to said counter input terminal and having an input line connected to receive said regularly occurring clock signals from said source;

(4) bistable circuit means having a set and a reset state and an output line coupled to said reset terminal of said N-stage binary counter, to an input of said gating means and to said resettable timing means;

(5) means coupling one of said plurality of output terminals of said N-stage binary counter to said bistable circuit means for switching said bistable circuit means to said reset state when the number of clock signals applied to said counter reachs a predetermined value;

(6) means for switching said bistable circuit means to said set state in response to a naturally occurring heart stimulating pulse;

(7) a further bistable circuit means having a set state, a reset state, an output terminal, a set input terminal and a reset input terminal;

(8) a coincidence gate having its input terminal connected to predetermined ones of said plurality of output terminals of said N-stage counter and its output terminal coupled to the reset terminal of said further bistable circuit means;

(9) means connecting said output terminal of said further bistable circuit means to said bistable circuit means for switching said bistable circuit means from its reset state to its set state and for enabling said gating means until said coincidence gate provides a reset signal to said further bistable circuit means; and

(10) means responsive to the generation of said artificial heart stimulating pulses for switching said further bistable circuit means to its set state.

4. An implantable heart pacer for applying artifical heart stimulating pulses of a predetermined pulse width and repetition rate to the heart of a patient comprising:

(b) a first binary register for storing a first predetermined binary number value corresponding to a desired stimulating pulse repetition rate, said first binary register having a plurality of outputs for carrying signals indicative of said first binary number value;

(b) a second binary register for storing a second predetermined binary number value corresponding to a desired stimulating pulse width said second binary register having a plurality of outputs for carrying signals indicative of said second binary number value;

(c) a first presettable counter having a clock input terminal, a load enable input terminal, a carry output terminal and a plurality of input terminals operatively coupled to said outputs of said first binary register for periodically receiving said first binary number value each time its load enable input terminal is stimulated;

(d) a second presettable counter having a clock input terminal, a carry output terminal, a load enable input terminal and a plurality of input terminals operatively coupled to said outputs of said second binary register for periodically receiving said second binary number value each time its load enable input terminal is stimulated;

(e) a source of regularly occurring timing signals coupled to said clock input terminals of said first and second presettable counters for changing the numbers stored therein at a fixed rate;

(f) means coupling said carry output terminal of said first presettable counter to said load enable terminals of said first and second presettable counter; and

(g) means coupling said carry output terminals of said first and second presettable counters to the heart of the patient;

the arrangement being such that when said first binary number value initially in said first presettable counter is changed by said timing signals to a given value, a heart stimulating pulse is initiated and when said second binary number value entered into said second presettable counter is changed by said timing signals to a given value, said heart stimulating pulse is terminated.

5. The pacer as in claim 4 and further including:

(a) digital logic means responsive to binary pulse code patterns generated external to the body of a patient for producing an enabling signal only when pulse code patterns of predetermined binary significance are received during a preset time interval; and

(b) means coupling said digital logic means to said first and second binary registers and responsive to said enabling signal for enabling the storing of a new digital value in said first and second binary registers.

6. Apparatus as in claim 4 and further including:

(a) a digital multiplexer means having first and second sets of input data terminals and a signal set of output terminals, said multiplexer means having said first set of input terminals connected to the output of said first binary number register and said single set of output terminals connected to the input terminals of said first presettable counter;

(b) magnetically actuable means responsive to the presence of an externally applied magnetic field for generating digital codes of predetermined significance indicative of voltage magnitude; and

(c) means coupling said magnetically actuable means to said second set of input data terminals of said digital multiplexer.

7. Apparatus as in claim 6 and further including:

(a) means connected to the plural outputs of said first binary number register for sensing the magnitude of said new digital value entered therein; and

(b) means responsive to said sensing means and coupled to said magnetically actuable means for causing a code of predetermined significance to be applied to said second set of input data terminals of said digital multiplexer when the magnitude of said new digital value lies outside of upper and lower limits.

8. Apparatus as in claim 4 and further including:

(a) counter reset means responsive to the occurrence of a natural heartbeat for stimulating said load enable input terminal of said first pdresettable counter only if said natural heatbeat occurs subsequent to a predetermined period following the next preceding one of said natural heartbeats.

9. Apparatus as in claim 8 wherein said counter reset means comprises:

(a) electrode means coupled to the heart of the patient;

(b) amplifier means having input terminals coupled to said electrode means and an output terminal;

(c) digital timing means including a third digital counter having a clock input terminal coupled through first gating means to said source of regularly occurring timing signals, a reset terminal and a plurality of output terminals;

(d) a bistable flip-flop having an input terminal coupled to said output terminal of said amplifier and an output coupled through second gating means to said reset terminal of said third digital counter and to said first gating means; and

(e) third gating means coupled to said plurality of output terminals of said third digital counter for inhibiting stimulation of said load enable input terminal of said first presettable counter until the number of timing signals accumulated in said third digital counter following the setting of said flip-flop reaches a predetermined value.

10. Apparatus as in claim 9 and further including:

(a) noise sensing means coupled to the output of said amplifier means, and to said second and third gating means for resetting said third digital counter upon the detection of noise during the period that said third digital counter is accumulating timing pulses and prior to the time when said third digital counter reaches said predetermined value.