Programmable automatic implantable cardioverter/defibrillator and pacemaker system

• US 4,989,602 A
• Filed: 04/12/1989
• Issued: 02/05/1991
• Est. Priority Date: 04/12/1989
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Siemens Pacesetter, Inc. (Abbott Laboratories)
• Inventors: Mann, Brian M., Sholder, Jason A.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US07/336,996
• Time in Patent Office: 664 Days
• Field of Search: 128/419 D, 128/419 P, 128/419 PG, 128/419 R
• US Class Current: 607/4
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/39622 Pacing therapy
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

A non-programmable automatic implantable cardioverter/defibrillator (AICD) capable of providing programmable thresholds for triggering high energy stimulation pulse(s) from the AICD is coupled to an implantable programmable pacemaker which preferably includes bradycardia support and/or tachycardia support using low enery output pulses. When the low energy antitachycardia pulse(s) from the pacemaker fail to terminate a tachycardia, or whenever other various thresholds, as sensed by programmable sensing circuits of the pacemaker, are exceeded, the high enery pulses from the AICD may be selectively invoked by an AICD trigger circuit included within the pacemaker. Coupling between the AICD and pacemaker is by either a direct electrical connection, or by an indirect connection, such as through the use of narrow pulse sequences generated by the pacemaker which are of insufficient energy to invoke a cardiac response but are of sufficient energy to be sensed by the AICD sensing circuits.

Claims

1. A programmable cardioverter/defibrillator system comprising:

(a) an automatic implantable cardioverter/ defibrillator (AICD), said AICD comprising;

high/low rate sensing means for sensing when a heart is beating above a fixed high threshold rate or below a fixed low threshold rate; and

means for delivering a high energy cardioversion/defibrillation pulse to the heart whenever said high/low rate sensing means senses that the heart is beating above the fixed high threshold rate or below the fixed low threshold rate;

(b) an implantable programmable pacemaker, said pacemaker comprising;

heart-rate sensing means for sensing the rate at which the heart is beating;

means for processing the sensed heart rate to determine whether the sensed heart rate lies within a programmed range of acceptable heart rates and for triggering the generation of said cardioversion/defibrillation pulse from said AICD so that the fixed high and low threshold rates of said AICD are replaced by the programmed range of heart rates of said implantable programmable pacemaker, said triggering occurring whenever the heart rate sensed by said heart rate sensing means of said pacemaker does not fall within said prescribed range of acceptable heart rates; and

programming means for allowing said programmed range of acceptable heart rates to be programmed into said processing means; and

(c) coupling means for coupling the operation of said AICD to said pacemaker.

2. The programmable cardioverter/defibrillator system of claim 1, wherein said coupling means comprises a direct electrical connection between said processing means of said pacemaker and said high/low rate sensing means of said AICD.

3. The programmable cardioverter/defibrillator system of claim 2, wherein said high/low rate sensing means of said AICD comprises a sensing electrode, and wherein said processing means of said pacemaker comprises a trigger circuit, and wherein said direct electrical connection is made between said trigger circuit and said sensing electrode.

4. The programmable cardioverter/defibrillator system of claim 3, wherein said trigger circuit comprises:

means for generating a first series of pulses at a rate which exceeds the fixed high threshold rate of said high/low rate sensing means when said processing means of said pacemaker determines that the sensed heart rate exceeds the programmed range of acceptable heart rates, whereby said high/low rate sensing means of said AICD senses said first series of pulses and interprets said first series of pulses as a heart rate which exceeds the fixed high threshold rate of the AICD, thereby delivering said high energy cardioversion/defibrillation pulse to the heart.

5. The programmable cardioverter/defibrillator system of claim 4, wherein said pacemaker further comprises:

means for delivering low energy stimulation pulses to the heart on demand in order to assist the heart in beating at a rate which is at least a programmed rate, and wherein said processing means of said pacemaker is programmed to deliver through said delivery means a first sequence of low energy pulses to the heart according to a first prescribed pattern upon the sensing of a fast heart rate by said heart-rate sensing means, said fast heart rate indicating a tachycardia condition, said first sequence of pulses being designed to break said tachycardia condition and cause the heart to beat at a slower rate, said processing means being further programmed to have said AICD deliver said high energy cardioversion/defibrillation pulse only in the event that said first sequence of low energy pulses generated by said pacemaker is unable to break said tachycardia condition.

6. The programmable cardioverter/defibrillator system of claim 3, wherein said trigger circuit comprises:

means for inhibiting the generation of any pulses for a prescribed period of time when said processing means of said pacemaker determines that the sensed heart rate is less than the programmed range of acceptable heart rates, whereby said high/low rate sensing means of said AICD fails to sense any heart rate within said prescribed period of time and interprets the same as a heart rate which is below the fixed low threshold rate of the AICD, thereby delivering said high energy cardioversion/defibrillation pulse to the heart.

7. The programmable cardioverter/defibrillator system of claim 6, wherein said pacemaker further comprises:

means for delivering low energy stimulation pulses to the heart on demand in order to assist the heart in beating at a rate which is at least a programmed rate, wherein said processing means of said pacemaker is programmed to deliver through said delivery means a sequence of low energy pulses to the heart according to a prescribed pattern upon the sensing of a slow heart rate by said heart-rate sensing means, said slow heart rate indicating a bradycardia condition, said sequence of pulses being designed to stop said bradycardia condition and cause the heart to beat at a faster rate, said processing means being further programmed to have said AICD deliver said high energy cardioversion/defibrillation pulse only in the event that said sequence of low energy pulses generated by said pacemaker is unable to stop said bradycardia condition.

8. The programmable cardioverter/defibrillator system of claim 1, wherein said pacemaker further comprises:

means for generating and delivering low energy stimulation pulses to the heart on demand in order to assist the heart in beating at a rate which is at least a programmed rate, wherein said coupling means comprises very low energy stimulation pulses of a specified energy generated by said pulse generating means of said pacemaker, delivered to the heart, and sensed by said high/low rate sensing means of said AICD, the specified energy of said low energy stimulation pulses being insufficient to stimulate the heart.

9. The programmable cardioverter/defibrillator system of claim 8, wherein said processing means of said pacemaker is further programmed to generate a first code sequence of said very low energy pulses when said processing means determines that the sensed heart rate is above said programmed range of acceptable heart rates, and a second code sequence of said very low energy pulses when said processing means determines that the sensed heart rate is below said programmed range of acceptable heart rates, wherein said AICD high/low rate sensing means further comprises means for sensing said first and second code sequences and discriminating therebetween.

10. A programmable implantable medical system for delivering high energy stimulation pulses to a heart whenever the heart rate exceeds a programmable threshold rate value, said system comprising:

an automatic implantable cardioverter/defibrillator (AICD) device, said AICD device comprising;

AICD sensing means for sensing when a heart rate is above a fixed high threshold rate value; and

means for delivering a high energy stimulation pulse to the heart whenever said AICD sensing means senses that the heart rate exceeds said fixed high threshold rate value; and

an implantable pacemaker device, said pacemaker device comprising;

pacemaker sensing means for sensing the heart rate;

means for processing the sensed heart rate to determine if it exceeds programmed criteria;

programming means for programming said specified criteria into said processing means; and

means for generating and delivering a sequence of very low energy pulses to the heart at a rate which exceeds the AICD fixed threshold rate in response to a determination by said processing means that the heart rate exceeds said programmed criteria, said very low energy pulses having an energy level sufficient to be detected by the AICD sensing means, but insufficient to stimulate the heart, said sequence of very low energy pulses being detectable by the AICD sensing means, whereby said delivery means of said AICD device responds by delivering said high energy stimulation pulse to the heart.

11. The programmable implantable medical system of claim 10, wherein said AICD sensing means of said AICD device further comprises:

means for sensing when the heart rate is less than a fixed low threshold rate value, and wherein said delivery means comprises;

means for delivering a high energy stimulation pulse to the heart whenever said AICD sensing means senses that the heart rate is less than said fixed low threshold rate value, whereby said AICD device delivers a high energy stimulation pulse to the heart whenever the AICD sensing means senses that the heart rate is less than the fixed low threshold rate value, and whenever the pacemaker heart rate sensing means senses that the heart rate exceeds said programmed criteria.

12. The programmable implantable medical system of claim 11, wherein the programmed criteria of said implantable pacemaker device comprises:

a heart upper rate limit, said upper rate limit comprising a heart rate value above which an undesirable heart condition is deemed to exist, said upper rate limit comprising a programmable value which is less than the fixed high threshold rate value of said AICD device.

13. In combination, an automatic implantable cardioverter/defibrillator (AICD) device and an implantable programmable pacemaker device, said pacemaker device comprising:

heart-rate sensing means for sensing the rate at which the heart is beating;

means for processing the sensed heart rate to determine whether said heart rate is within a specified range of acceptable heart rates;

programming means for allowing said specified range to be programmed into said processing means; and

signaling means within said pacemaker device for sending a trigger signal to said AICD device upon a determination by said processing means that the sensed heart rate is not within said specified range of acceptable heart rates;

said AICD device comprising;

AICD sensing means for sensing when a heart is beating above a fixed high threshold rate or below a fixed low threshold rate;

means for delivering a high energy stimulation pulse to the heart in response to receiving said trigger signal or in response to said AICD sensing means sensing that the heart is beating above the fixed high threshold rate or below the fixed low threshold rate; and

receiving means within said AICD device for receiving said trigger signal;

said trigger signal sent by said signaling means comprising a series of pulses having a frequency at least as great as said fixed high threshold rate of said AICD device, said series of pulses being sent directly to said AICD receiving means when the heart rate sensed by said heart-rate sensing means of said pacemaker is above said specified range of acceptable heart rates; and

said trigger signal comprising an inhibiting of all pulses sent directly to the AICD receiving means for a prescribed period of time when the heart rate sensed by said heart-rate sensing means of said pacemaker is below said specified range of acceptable heart rates.

14. The combination of claim 13 wherein said signal means of said pacemaker comprises a trigger circuit which generates or inhibits said series of pulses, and wherein said receiving means of said AICD device comprises a sensing electrode coupled to the AICD sensing means, and further wherein said sensing electrode is electrically connected to said trigger circuit by means of a direct electrical connection.

15. A method of converting fixed high or low rate threshold values of an automatic implantable cardioverter/defibrillator (AICD) device to programmable high or low rate threshold values, said AICD including means for generating a high energy cardioversion/defibrillation pulse whenever the heart rate sensed by sensing means within said AICD device either exceeds the fixed high rate threshold value or is less than the fixed low rate threshold value, said method comprising the steps of:

coupling a programmable pacemaker to said AICD device by way of a direct electrical connection between a sensing electrode of said AICD device and a trigger circuit of said pacemaker, said pacemaker further including heart rate sensing means for sensing when the heart rate exceeds a programmable upper limit and is less than a programmable lower limit; and

triggering the generation of said high energy cardioversion/defibrillation pulse whenever the heart rate sensing means of said pacemaker senses a rate which exceeds the programmable upper limit or is less than the programmable lower limit.

16. A method of converting fixed high or low rate threshold values of an automatic implantable cardioverter/defibrillator (AICD) device to programmable high or low rate threshold values, said AICD including means for generating a high energy cardioversion/defibrillation pulse whenever the heart rate sensed by sensing means within said AICD device either exceeds the fixed high rate threshold value or is less than the fixed low rate threshold value, said method comprising the steps of:

coupling a programmable pacemaker to said AICD device, said pacemaker including heart rate sensing means for sensing when the heart rate exceeds a programmable upper limit and is less than a programmable lower limit; and

triggering the generation of said high energy cardioversion/defibrillation pulse whenever the heart rate sensing means of said pacemaker senses a rate which exceeds the programmable upper limit or is less than the programmable lower limit;

said coupling step comprising;

generating a low energy pulse within said pacemaker, said low energy pulse having insufficient energy to stimulate the heart, but sufficient energy to be sensed by the sensing means of said AICD device;

applying said low energy pulse to said heart at a rate that exceeds said fixed high rate threshold; and

detecting the presence of said low energy pulse within the sensing circuits of said AICD.

17. In combination, an automatic implantable cardioverter/defibrillator (AICD) device and an implantable programmable pacemaker device, said pacemaker device comprising:

heart-rate sensing means for sensing the rate at which the heart is beating;

means for processing the sensed heart rate to determine whether said heart rate is within a specified range of acceptable heart rates;

programming means for allowing said specified range to be programmed into said processing means; and

signaling means within said pacemaker device for sending a trigger signal to said AICD device upon a determination by said processing means that the sensed heart rate is not within said specified range of acceptable heart rates;

means for generating and delivering low energy stimulation pulses as controlled by said processing means;

said AICD device comprising;

AICD sensing means for sensing when a heart is beating above a fixed high threshold rate or below a fixed low threshold rate;

means for delivering a high energy stimulation pulse to the heart in response to receiving said trigger signal or in response to said AICD sensing means sensing that the heart is beating above the fixed high threshold rate or below the fixed low threshold rate; and

receiving means within said AICD device for receiving said trigger signal;

said signaling means of said pacemaker device comprising a series of very low energy pulses which are generated and delivered to the heart by said stimulation pulse delivery means of said pacemaker device at a rate which exceeds said fixed high threshold rate of said AICD sensing means, and wherein said receiving means within said AICD device comprises said AICD sensing means, said very low energy pulses having an energy level sufficient to be detected by said AICD sensing means, but insufficient to stimulate the heart, whereby said AICD sensing means senses the series of very low energy pulses and interprets the same to be the heart beating at a rate which exceeds said fixed high rate threshold, whereby said delivery means of said AICD device responds by delivering said high energy stimulation pulse to the heart.

18. The combination of claim 17 wherein said sensing means, processing means and pulse generation and delivery means included within said pacemaker device further comprise:

means for controlling the delivery of said very low energy stimulation pulses with the rhythm of the heart so that each pulse of said series of low energy pulses occurs within the beating cycle of the heart at a time which allows it to be detected by said AICD sensing means.

19. The combination of claim 17 wherein said trigger signal sent by said signaling means comprises one of a plurality of different burst patterns of said very low energy pulses which are generated and delivered to the heart by said pulse generation and delivery means of said pacemaker device, and further wherein said receiving means within said AICD device includes discrimination means for discriminating between said different burst patterns, whereby each of said different burst patterns can be detected and identified by the receiving and discrimination means within said AICD device.

20. The combination of claim 19 wherein a first of said plurality of very low energy burst patterns signals that a heart rate lower than the specified range of acceptable heart rates programmed into said processing means has been sensed, and a second of said plurality of low energy burst patterns signals that a heart rate higher than the specified range of acceptable heart rates programmed into said processing means has been sensed.