Implantable heart stimulator and stimulation method

• US 4,407,288 A
• Filed: 03/16/1981
• Issued: 10/04/1983
• Est. Priority Date: 02/18/1981
• Status: Expired due to Term

• Current Assignee: Mieczyslaw Mirowski, Mirowski Family Ventures LLC
• Original Assignee: Mieczyslaw Mirowski
• Inventors: Mower, Morton M., Langer, Alois A., Heilman, Marlin S., Kolenik, Steve A., Mirowski, Mieczyslaw
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/243,801
• Time in Patent Office: 932 Days
• Field of Search: 128/419 D, 128/419 PG
• US Class Current: 607/4
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37258 Alerting the patient
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

An implantable heart stimulator and related method calls for the determination of a given heart condition from among a plurality of conditions, the selection of at least one mode of operation for treating the determined condition, and the execution of the mode of operation selected, so as to treat the determined condition. In one embodiment of the invention, wherein a plurality of modes of operation for treating the various conditions are provided, the implantable heart stimulator includes processors, each processor being designed to efficiently execute a respective group of modes of operation. A further embodiment of the present invention calls for the implantable heart stimulator to be implemented by at least one programmable microprocessor. A still further embodiment calls for the provision of a data input/output channel, by means of which data can be provided to and retrieved from the implantable heart stimulator. Operations carried out by the implantable heart stimulator includes cardiac pacing, cardioversion, and automatic defibrillation. In a further embodiment of the implantable heart stimulator and related method, sensing circuitry is provided to determine the presence or absence of an R-wave of the heart, the absence of which causes a pacing operation to be implemented, further sensing circuitry being provided to determine the presence or absence of a forced R-wave of the heart, the absence of a forced R-wave causing ventricular defibrillation to be implemented.

Claims

1. A method of heart stimulation using an implantable heart stimulator capable of detecting a plurality of arrhythmias and capable of being programmed to undergo a single or multi-mode operation to treat a detected arrhythmia, corresponding to said mode of operation the method comprising the steps of:

(a) determining a condition of the heart from among a plurality of conditions of the heart;

(b) selecting at least one mode of operation of the implantable heart stimulator which operation includes a unique sequence of events corresponding to said determined condition; and

(c) executing said at least one mode of operation of said implantable heart stimulator thereby to treat said determined heart condition.

2. The method of claim 1, further comprising the step (d) of repeating said steps (a)-(c), whereby to continuously monitor and treat determined heart conditions.

3. The method of claim 1, wherein said at least one mode of operation of said implantable heart stimulator includes a cardiac pacer mode of operation.

4. The method of claim 1, wherein said at least one mode of operation of said implantable heart stimulator includes cardioversion.

5. The method of claim 1, wherein said at least one mode of operation of said implantable heart stimulator includes automatic defibrillation.

6. The method of claim 1, wherein said at least one mode of operation of said implantable heart stimulator comprises a plurality of unique modes of operation of said implantable heart stimulator corresponding to respective arrhythmias, said method further comprising the step of providing said implantable heart stimulator with dual processors, one of said dual processors being designed to efficiently implement a first group of said plurality of modes of operation of said implantable heart stimulator, and a second one of said dual processors being designed to efficiently implement a second group of said plurality of modes of operation of said implantable heart stimulator.

7. The method of claim 1, wherein said implantable heart stimulator is microprocessor-controlled, said method further comprising the step of externally programming said microprocessor-controlled implantable heart stimulator with respect to said at least one mode of operation thereof.

8. The method of claim 1, wherein said implantable heart stimulator is capable of operation in a cardiac pacer mode of operation and an automatic defibrillation mode of operation;

said step (a) comprising determining the presence or absence of a naturally induced R-wave of the heart rhythm;

said step (b) comprising selecting said cardiac pacer mode of operation;

said step (c) comprising executing said cardiac pacer mode of operation to pace the heart;

said method comprising the further steps of;

(d) determining the presence or absence of a forced R-wave;

(e) selecting, in the absence of said forced R-wave, the automatic defibrillation mode of operation; and

(f) executing, in the absence of said forced R-wave, said automatic defibrillation mode of operation to automatically defibrillate the heart.

9. The method of claim 8, wherein said step (e) further comprises, in the presence of a forced R-wave, returning to said step (a).

10. An implantable heart stimulator capable of monitoring and detecting a plurality of arrhythmias, and capable of being programmed to undergo a single or multi-mode of operation corresponding to a respective arrhythmia to treat automatically the detected arrhythmia, said stimulator comprising:

determining means for determining the occurrence of one of a plurality of conditions of the heart;

selecting means responsive to said determining means for selecting at least one mode of operation of said implantable heart stimulator corresponding to a respective one of said plurality of conditions for automatically treating said determined conditions; and

executing means for executing a sequence of events defined by said at least one mode of operation, whereby to treat said determined condition.

11. The stimulator of claim 10, wherein said implantable heart stimulator continuously monitors the heart in order to determine the occurrence of any said plurality of conditions.

12. The stimulator of claim 10, wherein said at least one mode of operation includes cardiac pacing.

13. The stimulator of claim 10, wherein said at least one mode of operation includes cardioversion.

14. The stimulator of claim 10, wherein said at least one mode of operation includes aromatic defibrillation.

15. The stimulator of claim 10, wherein said determining means comprises a first detecting circuit for detecting presence or absence of a naturally induced R-wave of the heart, and a second detecting circuit for detecting presence or absence of a forced R-wave of the heart, said selecting means being responsive to absence of said natural R-wave for selecting a cardiac pacer mode of operation, said executing means being responsive to selection of said cardiac pacer mode of operation for pacing the heart, said selecting means being responsive to absence of said forced R-wave for selecting an automatic defibrillation mode of operation, said executing means being responsive to selection of said automatic defibrillation mode of operation for automatically defibrillating the heart.

16. The stimulator of claim 15, wherein said second detecting circuit is actuated to detect the presence or absence of said forced R-wave only after selection and execution of said cardiac pacer mode of operation.

17. The stimulator of claim 16, wherein said selecting means responds to detection of said forced R-wave by inhibiting execution of said automatic defibrillator mode of operation.

18. The stimulator as recited in claim 10 further including a programmable control store for defining a sequence of electrical events corresponding to at least one mode of operation and corresponding operating parameters associated with said mode of operation;

and

an input/output data channel connected to said control store for transferring data therewith which define the sequence of electrical events to be performed by said at least one mode of operation thereby to affect treating operations particularly suited to the patient.

19. The stimulator as recited in claim 18 wherein said programmable control store defines a defibrillating mode of operation and a set of operating parameters including step wise increased energy levels for said defibrillating pulses, said executing means being responsive to said programmable control store to defibrillate the heart in accordance with the programmed mode of operation and the defined operating parameters associated therewith.

20. An implantable heart stimulator for monitoring a heart and treating a plurality of conditions of said heart, comprising:

input means for receiving various status and sensor input signals;

controller means for processing said various status and sensor input signals to determine the occurrence of a given condition from among said plurality of conditions, and for selectively performing a sequence of events defined by at least one mode of operation corresponding to and for treating said determined condition, and issuing corresponding control output signals; and

output means responsive to said control output signals of said controller means for electrically stimulating the heart so as to treat said determined condition.

21. The stimulator of claim 20 wherein said controller selectively performs a plurality of modes of operation and includes first and second processors, said first processor adapted to execute a first group of said plurality of modes of operation so as to treat a first group of a corresponding plurality of conditions, said second processor adapted to execute a second group of said plurality of modes of operation so as to treat a second group of a corresponding plurality of conditions.

22. The stimulator of claim 20, further comprising data input/output channel means for transferring data with said implantable heart stimulator.

23. The stimulator of claim 20 further including an input/output data channel for transferring data with said controller means and wherein said controller means comprises at least one programmable microprocessor for generating said output control signals in dependence on said data signals received through said input/output data channel.

24. The stimulator of claim 20, wherein said output means includes a cardiac pacer.

25. The stimulator of claim 20, wherein said output means includes a cardioverting device.

26. The stimulator of claim 20, wherein said output means comprises an automatic defibrillator.

27. The stimulator of claim 20, wherein said at least one mode of operation includes a cardiac pacer mode of operation and an automatic defibrillator mode of operation, said input means receiving a first sensor input signal corresponding to presence or absence of a naturally induced R-wave of the heart and a second sensor input signal corresponding to presence or absence of a forced R-wave of the heart, said controller means determining the absence of said natural R-wave of the heart and responding thereto by issuing a cardiac pacer control output signal to effect cardiac pacing of the heart, said controller means subsequently determining the presence or absence of said forced R-wave of the heart and responding to the absence thereof by issuing an automatic defibrillation control output signal to effect automatic defibrillation of the heart.

28. The stimulator of claim 27, wherein said controller means responds to the presence of said forced R-wave of the heart by monitoring said R-wave sensor input signal and inhibiting further electrical stimulation of the heart until absence of said naturally induced R-wave of the heart is detected.

29. A stimulator as recited in claim 20 further including

a program control store for defining a sequence of electrical events for at least one operating mode to pace, cardiovert or defibrillate a heart;

and

means for further defining at least one parameter associated with said at least one operating mode.

30. A stimulator as recited in claim 29 wherein said defined parameter includes the level of intensity of a pacing signal, defibrillating pulse, or cardioverting pulse.

31. The stimulator as recited in claim 30 wherein the defined sequence of electrical events includes a set of step-wise increased energy levels for said defibrillating, and said executing means issues said defibrillating pulses in successive step-wise increased energy levels until completion of defibrillation.

32. The stimulator as recited in claim 31 wherein the defined parameter includes a preprogrammed number of defibrillating pulses.

33. The stimulator as recited in claim 30 when the defined parameter includes a preprogrammed number of defibrillating pulses.

34. The stimulator as recited in claim 30 wherein the parameters defined by said control store include any combination of the group including the number and level of pulses which treat the heart, perodicity of pulses which treat the heart, tachcardia threshold rate, R-R coupling interval, decrement for R-R coupling interval, width of

said executing means effects treatment of the heart in accordance with at least one of said defined parameters.

35. The stimulator as recited in claim 34 further comprising

an input/output data channel for transferring data with said controller means,

said control means generating said output control signals in accordance with the data signals received through said input/output data channel.

36. The stimulator as recited in claim 29 further comprising

an input/output data channel for transferring data with said control means,

said control means generating said output control signals in accordance with the data signals received through said input/output data channel.

37. The stimulator as recited in claim 20 further including a programmable control store for defining a sequence of electrical events corresponding to at least one mode of operation and associated operating parameters associated with said operation;

and

an input/output data channel connected to said control store for transferring data therewith which define the sequence of electrical events to be performed by said at least one mode of operation thereby to affect treating operations particularly suited to the patient.