Implantable cardiac pacemaker

• US 4,567,892 A
• Filed: 03/10/1983
• Issued: 02/04/1986
• Est. Priority Date: 03/16/1982
• Status: Expired due to Term

• Current Assignee: Biotec International SPA, Schiapparelli Medtronic SPA
• Original Assignee: Giancarlo Canducci, Gianni Plicchi
• Inventors: Plicchi, Gianni, Canducci, Giancarlo
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/474,241
• Time in Patent Office: 1,062 Days
• Field of Search: 128/723, 128/419 PG, 128/693, 128/734
• US Class Current: 607/20
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61N 1/36521 the parameter being derived from measurement of an electrical impedance

Abstract

An implantable cardiac pacemaker in which the stimulation rate is determined through a suitable programmable algorithm by the patient'"'"'s ventilation rate which is taken by measuring the impedance variations throughout a distance within the human body; preferably a distance within the thoracic region that goes between the pacemaker box and the lead which is placed subcutaneously. The pacemaker is constructed to detect variations, even rapid ones, of the corporeal impedance and to discriminate substantial variations attributable in all probability to a respiratory act, as well as to limit the drain of electrical energy.

Claims

1. A heart pacemaker implantable in a patient, said pacemaker comprising:

impedance responsive means constructed to be operatively associated with the patient for detecting impedance variations in the patient'"'"'s body which are at least in part dependent on the act of respiration and for deriving an impedance signal corresponding in value to such impedance variations;

signal extraction means connected to said impedance responsive means for deriving from the impedance signal a respiration dependent signal which undergoes a variation in value each time the value of the impedance signal exceeds a selected threshold value, whereby the respiration dependent signal is a periodic signal synchronized with respiration acts of the patient;

programmable signal generating means connected to said signal extraction means for deriving from the respiration dependent signal a stimulation control signal which is linearly proportional to the respiratory rate of the patient, between selected upper and lower limits;

heart stimulation means connected to said signal generating means for supplying stimulation signals to the patient'"'"'s heart at a rate controlled by the stimulation control signal; and

programming means operatively associated with said signal extraction means for adjusting the selected threshold value under control of programming signals delivered from outside the patient'"'"'s body.

2. A pacemaker as defined in claim 1 wherein:

said heart stimulation means include at least one implantable electrode for applying the stimulation pulses to the patient'"'"'s heart; and

said impedance responsive means comprise two measuring electrodes one of which is conductively connected to said at least one implantable electrode and the other of which is insertable subcutaneously at a selected distance from said one measuring lead.

3. A pacemaker as defined in claim 2 further comprising an external case having an electrically conductive outer surface constituting said one measuring electrode.

4. A pacemaker as defined in claim 1 wherein said impedance responsive means are operative for monitoring the impedance between two selected points of the patient'"'"'s body in response to application of an electrical signal having a selected intensity between those points, and said impedance responsive means comprise:

two measuring electrodes installable at the selected points; and

means connected to apply between said electrodes a succession of pulses of the electrical signal having the selected intensity, the pulses being of short duration and the succession of pulses having a high ratio of pulse repetition period to pulse duration, whereby the impedance is monitored at regular intervals with low energy consumption.

5. A pacemaker as defined in claim 4 wherein the electrical signal is a current and said means for applying a succession of pulses comprise a current generator connected to be actuated by a short duration signal triggering each electrical signal pulse, and to be turned off between pulses to minimize energy consumption.

6. A pacemaker as defined in claim 5 wherein the ratio of pulse repetition period to pulse duration is of the order of 1000 to 1.

7. A pacemaker as defined in claim 5 further comprising a supply voltage source, and wherein said signal extraction means comprise:

a first amplifier having first and second inputs and an output and having its first input connected to receive the impedance signal derived by said impedance responsive means;

a first comparator having a first input connected to said first amplifier output, a second input connected to receive a first reference voltage substantially equal to one-half the supply voltage, and an output supplying a signal each time the value of the signal at said first input exceeds the value of the signal of said second input;

a first flip-flop having a set input, a reset input and an output, with said reset input being connected to said output of said first comparator;

a source of a first control signal corresponding to the short duration signal triggering each electrical signal pulse, said source being connected for applying said first control signal to said set input of said first flip-flop; and

means including an RC network connecting said output of said first flip-flop to said second input of said first amplifier;

wherein the voltage, V_H, at the output of said first amplifier has a value;

space="preserve" listing-type="equation">A.sub.o |V.sub.c -V.sub.x |, where

A_o is the gain of said first amplifier, V_x is the voltage of the signal at said first input of said first amplifier, and V_c is the voltage of the signal at said second input of said first amplifier, and wherein the time constant of said RC network is sufficiently long to adapt V_c to long term variations of the patient'"'"'s body impedance detected by said impedance responsive means.

8. A pacemaker as defined in claim 7 wherein said signal extraction means comprise a modified delta modulator containing said first amplifier.

9. A pacemaker as defined in claim 8 wherein said signal extraction means further comprise a second comparator having a first input connected to said first amplifier output, a second input connected to receive a second reference voltage having a value greater than said first reference voltage and constituting the selected threshold value, and an output supplying a signal each time the value of the signal at said first input of said second comparator exceeds the value of the signal at said second input of said second comparator, wherein said first and second comparators constitute a sensitivity control circuit for discriminating between consistent and inconsistent body impedance variations detected by said impedance responsive means.

10. A pacemaker as defined in claim 9 wherein the values of the first and second reference voltages are programmable by said programming means and said first amplifier and said comparators are connected to receive operating power during short periods when the impedance signal is being produced in response to each current pulse.

11. A pacemaker as defined in claim 9 wherein said first comparator comprises means for producing a signal pulse each time a signal appears at said output of said first comparator, said second comparator comprises means for producing a signal pulse each time a signal appears at said output of said second comparator, and said signal extraction means further comprises a third comparator connected to receive the signal pulses produced by said signal pulse producing means of said first and second comparators, said third comparator having an output which provides a signal constituting the respiration dependent signal which undergoes such variation in value in response to a first signal pulse from said signal pulse producing means of said second comparator and until passage of a selected time interval during which no signal pulse is produced by said signal pulse producing means of said first comparator.

12. A pacemaker as defined in claim 11 wherein:

said RC network comprises a compacitor and a first resistor which together establish the sufficiently long time constant;

said network further comprises a second resistor having a lower resistance than said first resistor; and

said programming means are operative for selectively and temporarily connecting said second resistor in parallel with said first resistor at the start of operation of said pacemaker for rapidly adapting the response of said signal extraction means to the value of the body impedance the variations of which are being detected.

13. A pacemaker as defined in claim 4 wherein said impedance responsive means further comprise:

control signal generating means connected for applying to said current generator the short duration control signal triggering each electrical signal pulse; and

circuit means connected between said measuring electrodes and controlled by the short duration control signal for establishing a short circuit between said measuring electrodes during the intervals between the electrical signal pulses in order to prevent difficulties resulting from the fact that the impedance between the two selected points of the patient'"'"'s body is not purely resistive.

14. A pacemaker as defined in claim 1 wherein the stimulation control signal produced by said programmable signal generating means establishes a selected linear relation between the respiration rate indicated by the respiration dependent signal and a selected function controlled by the signals produced by said heart stimulation means.

15. A pacemaker as defined in claim 14 wherein the selected function is inhibition rate.

16. A pacemaker as defined in claim 14 wherein the selected function is atrial stimulation rate.

17. A pacemaker as defined in claim 14 wherein the selected function is ventricular stimulation rate.

18. A pacemaker as defined in claim 1 wherein said programming means comprise means for transmitting to a location outside of the patient'"'"'s body signals representative of respiration acts and means for transmitting from the location outside of the patient'"'"'s body to said signal extraction means and said programmable signal generating means control signals for controlling the sensitivity of said signal extraction means to the intensity of respiration and for controlling the relation between the respiration dependent signal and at least one of inhibition rate and heart stimulation rate.

19. A pacemaker as defined in claim 18 wherein said programming means comprise means for transmitting from the location outside of the patient'"'"'s body a selected coded signal, and implantable receiving means responsive to the coded signal for temporarily shortening the time constant of said RC network at the start of operation of said pacemaker.

20. A pacemaker as defined in claim 19 wherein said means for transmitting further constitute a source of a first setting signal representing the desired magnitude of the selected threshold value and a second setting signal representing the desired proportional relation between the stimulation control signal and the respiration rate indicated by the respiration dependent signal, and said receiving means are operative for adjusting the selected threshold value in dependence on the first setting signal and for adjusting the relation between the stimulation control signal and the respiration dependent signal in dependence on the second setting signal.

21. A pacemaker as defined in claim 20 wherein said means for transmitting further constitute a source of a third setting signal, and said receiving means are further operative for responding to occurrence of the third setting signal for causing said heart stimulation means to supply stimulating signals at a selected rate independent of the respiration dependent signal.

22. A pacemaker as defined in claim 1 further comprising means connected for preventing the rate of the stimulation signals produced by said heart stimulation means from passing beyond selected upper and lower limits independently of the rate of the patient'"'"'s respiration acts.

23. In a heart pacemaker implantable in a patient, the pacemaker comprising:

impedance responsive means constructed to be operatively associated with the patient for detecting impedance variations in the patient'"'"'s body which are at least in part dependent on the act of respiration and for deriving an impedance signal corresponding in value to such impedance variations, and

heart stimulation means connected to the impedance responsive means for supplying stimulation signals to the patient'"'"'s heart at a rate controlled by the impedance signal,

the improvement wherein said impedance responsive means are operative for monitoring the impedance between two selected points of the patient'"'"'s body in response to application of an electrical signal having a selected intensity between those points, and said impedance responsive means comprise;

two measuring electrodes installable at the selected points; and

means connected to apply between said electrodes a succession of pulses of the electrical signal having the selected intensity, the pulses being of short duration and the succession of pulses having a high ratio of pulse repetition period to pulse duration, whereby the impedance is monitored at regular intervals with low energy consumption.

24. A pacemaker as defined in claim 23 wherein the electrical signal is a current and said means for applying a succession of pulses comprise a current generator connected to be actuated by a short duration signal triggering each electrical signal pulse, and to be turned off between pulses to minimize energy consumption.

25. A pacemaker as defined in claim 24 wherein the ratio of pulse repetition period to pulse duration is of the order of 1000 to 1.

26. A pacemaker as defined in claim 23 wherein said impedance responsive means further comprise:

control signal generating means connected for applying to said current generator the short duration control signal triggering each electrical signal pulse; and

circuit means connected between said measuring electrodes and controlled by the short duration control signal for establishing a short circuit between said measuring electrodes during the intervals between the electrical signal pulses in order to prevent difficulties resulting from the fact that impedance between the two selected points of the patient'"'"'s body is not purely resistive.

27. In a heart pacemaker implantable in a patient, the pacemaker comprising:

detecting means constructed to be operatively associated with the patient for detecting variations in a parameter of the patient'"'"'s body and for deriving a signal corresponding in value to such variations, and

heart stimulation means connected to the detecting means for supplying stimulation signals to the patient'"'"'s heart at a rate controlled by the signal,

the improvement wherein said detecting means are operative for monitoring the parameter between two selected points of the patient'"'"'s body in response to application of an electrical signal having a selected intensity between those points, and said detecting means comprise;

two measuring electrodes installable at the selected points; and

means connected to apply between said electrodes a succession of pulses of the electrical signal having the selected intensity, the pulses being of short duration and the succession of pulses having a high ratio of pulse repetition period to pulse duration, whereby the parameter is monitored at regular intervals with low energy consumption.