Implantable arrhythmia system with protection against release of unneeded pulses

• US 5,190,034 A
• Filed: 01/10/1991
• Issued: 03/02/1993
• Est. Priority Date: 01/10/1991
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Siemens Pacesetter, Inc. (Abbott Laboratories)
• Inventors: Sholder, Jason A.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): MANUEL, GEORGE C
• Application Number:
  US07/639,642
• Time in Patent Office: 782 Days
• Field of Search: 128/419 D, 128/419 PG, 128/419 PT
• US Class Current: 607/5
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting

Abstract

An implantable arrhythmia treatment system includes a sensor which generates an electrical signal corresponding to a physiological characteristic of a patient, the physiological characteristics and thus the electrical signal exhibit a change given the onset of an arrhythmia. The electrical signal is supplied to a fibrillation detector in an implantable housing, which initiates an appropriate treatment sequence upon the detection of the onset of the arrhythmia. Simultaneously with initiating the treatment sequence, the fibrillation detector causes, either by direct connection or by telemetry communication, the generation of an alarm signal which informs the patient that the sequence has been initiated, so that the patient knows that a treatment pulse is about to be released. The implantable unit includes circuitry responsive to a signal externally generated by the patient which prevents the release of the defibrillating pulse. If the patient feels no need for such a pulse, i.e. if the onset of the arrhythmia has been erroneously detected, the patient can thereby prevent the release of the pulse.

Claims

1. An arrhythmia treatment system comprising:

sensor means adapted for implantation in a patient for sensing a physiological characteristic which exhibits a change upon the onset of cardiac arrhythmia and for generating an electrical signal corresponding to said physical characteristic;

treatment means contained in a housing adapted for implantation in a patient, said treatment means adapted to be connected in vivo to said sensor means to receive said electrical signal therefrom for initiating an arrhythmia treatment sequence, including releasing a treatment pulse in vivo to said patient via electrodes adapted for implantation in said patient, in response to said change in said physical characteristic;

means in communication with said treatment means for informing said patient, substantially simultaneously with the initiation of said arrhythmia treatment sequence, that said arrhythmia treatment sequence has been initiated; and

means in communication with said treatment means and operable by said patient for optionally stopping said arrhythmia treatment sequence before releasing said treatment pulse.

2. An arrhythmia treatment system, as claimed in claim 1, wherein said means for informing said patient that said arrhythmia treatment sequence has been initiated includes a sensory alarm.

3. An arrhythmia treatment system, as claimed in claim 2, wherein said sensory alarm is disposed externally of said patient.

4. An arrhythmia treatment system, as claimed in claim 3, wherein said means for informing said patient that said arrhythmia treatment sequence has been initiated further includes telemetry transmitter means disposed in said housing for transmitting a telemetry signal in response to said change in said physical characteristic and telemetry receiver means disposed externally of said patient for receiving said signal from said telemetry transmitter means and for actuating said sensor alarm.

5. An arrhythmia treatment system, as claimed in claim 4, wherein said means operable by said patient for optionally stopping said arrhythmia treatment sequence includes means in said housing for stopping said arrhythmia treatment sequence in the presence of a magnetic field, and a magnet manipulably by said patient to place said magnetically responsive means in the presence of a magnetic field generated by said magnet.

6. An arrhythmia treatment system, as claimed in claim 5, wherein said treatment means includes a voltage source and means for charging a capacitance from said voltage source in response to said change in said physical characteristic to generate said treatment pulse, and wherein said magnetically responsive means includes a magnetically actuated normally closed switch connected between said voltage source and said means for charging which switches to an open state in the presence of said magnetic field.

7. An arrhythmia treatment system, as claimed in claim 6, further comprising a dummy load contained in said housing, and wherein said magnetically responsive means includes a magnetically actuated switch means connected to an output of said means for charging, to said electrodes and to said dummy lead for normally connecting said output to said electrodes and switchable to permit discharge of said capacitance into said dummy load in the presence of said magnetic field.

8. An arrhythmia treatment system, as claimed in claim 3, wherein said means for informing said patient that said arrhythmia treatment sequence has been initiated further includes first telemetry transceiver means disposed in said housing for transmitting a telemetry signal in response to said change in said physical characteristic, and for receiving externally generated telemetry signals, and second telemetry transceiver means disposed externally of said patient for receiving said signal from said first telemetry transceiver means and for actuating said sensor alarm, and for generating external telemetry signals.

9. An arrhythmia treatment system, as claimed in claim 8, wherein said means operable by said patient for optionally stopping said arrhythmia treatment sequence includes means in said housing for stopping said arrhythmia sequence upon the telemetric receipt of an inhibit instruction, and logic means, connected to said second telemetry transceiver means, operable by said patient for generating said inhibit instructions, said inhibit instruction being telemetrically transmitted from said second telemetry transceiver means to said first telemetry transceiver means and thereby stopping said arrhythmia treatment sequence.

10. An arrhythmia treatment system, as claimed in claim 9, wherein said treatment means includes a voltage source and means for charging a capacitance from said voltage source in response to said change in said physical characteristic to generate said treatment pulse, and wherein said means responsive to said inhibit instruction is a means for ceasing charging of said capacitance upon receipt of said inhibit instruction.

11. An arrhythmia treatment system, as claimed in claim 10, further comprising a dummy load contained in said housing, and wherein said means responsive to said inhibit instruction includes switch means connected to an output of said means for charging, to said electrodes and to said dummy load for normally connecting said output to said electrodes and switchable in response to said inhibit instruction to permit discharge of said capacitance into said dummy load.

12. An arrhythmia treatment system, as claimed in claim 2, wherein said sensory alarm is disposed in said housing.

13. An arrhythmia treatment system, as claimed in claim 12, wherein said means operable by said patient for optionally stopping said arrhythmia treatment sequence includes means in said housing for stopping said arrhythmia treatment sequence in the presence of a magnetic field, and a magnet manipulable by said patient to place said magnetically responsive means in the presence of a magnetic field generated by said magnet.

14. An arrhythmia treatment system, as claimed in claim 13, wherein said treatment means includes a voltage source and means for charging a capacitance from said voltage source in response to said change in said physical characteristic to generate said treatment pulse, and wherein said magnetically responsive means includes a magnetically actuated normally closed switch connected between said voltage source and said means for charging which switches to an open state in the presence of said magnetic field.

15. An arrhythmia treatment system, as claimed in claim 14, further comprising a dummy load contained in said housing, and wherein said magnetically responsive means includes a magnetically actuated switch means connected to an output of said means for charging, to said electrodes and to said dummy load for normally connecting said output to said electrodes and switchable to permit discharge of said capacitance into said dummy load in the presence of said magnetic field.

16. An arrhythmia treatment system, as claimed in claim 12, wherein said means operable by said patient for optionally stopping said arrhythmia treatment sequence includes telemetry receiver means disposed in said housing for receiving an externally generated inhibit instruction and first logic means disposed in said housing for stopping said arrhythmia treatment sequence upon receipt of said inhibit instruction by said telemetry receiver means, second logic means, disposed externally of said patient and operable by said patient, for generating said inhibit instruction, and telemetry transmitter means disposed externally of said patient and connected to said second logic means for telemetrically transmitting said inhibit instruction to said telemetry receiver means.

17. An arrhythmia treatment system, as claimed in claim 16, wherein said treatment means includes a voltage source and means for charging a capacitance from said voltage source in response to said change in said physical characteristic to generate said treatment pulse, and wherein said first logic means is a means for ceasing charging of said capacitance upon receipt or said inhibit instruction.

18. An arrhythmia treatment system, as claimed in claim 17, further comprising a dummy load contained in said housing and wherein said means for optionally stopping said arrhythmia treatment sequence includes a switch in said housing connected to an output of said means for charging, to said electrodes and to said dummy load for normally connecting said output to said electrodes and switchable in response to said inhibit instruction to permit discharge of said capacitance into said dummy load.

19. An arrhythmia treatment system, as claimed in claim 1, wherein said treatment means includes a voltage source and means for charging a capacitance from said voltage source in response to said change in said physical characteristic to generate said treatment pulse, and wherein said means for optionally stopping said arrhythmia treatment sequence includes means for ceasing charging of said capacitance.

20. An arrhythmia treatment system, as claimed in claim 19, further comprising a dummy load contained in said housing, and wherein said means for optionally stopping said arrhythmia treatment sequence includes switch means connected to an output of said means for charging, to said electrodes and to said dummy load for normally connecting said output to said electrodes and switchable to permit discharge of said capacitance into said dummy load if said patient stops said arrhythmia treatment sequence.

21. An arrhythmia treatment system comprising:

sensor means adapted for implantation in a patient for sensing a physiological characteristic which exhibits a change upon the onset of cardiac arrhythmia and for generating an electrical signal corresponding to said physical characteristic;

means contained in a housing adapted for implantation in a patient and adapted to be connected in vivo to said sensor means to receive said electrical signal therefrom for generating a treatment initiation signal upon the onset of cardiac arrhythmia;

a voltage source in said housing;

means in said housing for charging a capacitance from said voltage source in response to said treatment initiation signal for generating a treatment pulse;

pulse output means connected to an output of said means for charging for releasing said treatment pulse after a time following said treatment initiation signal;

alarm means connected to said means for generating said treatment initiation signal for receiving said signal therefrom for informing a patient in whom said housing is implanted that a treatment sequence has been initiated;

first logic means disposed externally of said patient and optionally operable by said patient to generate an inhibit instruction after said patient has been informed that a treatment sequence has been initiated;

telemetry transmitter means disposed externally of said patient and connected to said first logic means for telemetrically transmitting said inhibit instruction;

telemetry receiver means disposed in said housing for receiving said inhibit instruction from said telemetry transmitter means; and

second logic means disposed in said housing and connected to said telemetry receiver means and said means for charging for preventing, in response to the receipt said inhibit instruction before elapse of said time, at least one of further charging of said capacitance by said means for charging or releasing of said treatment pulse by said pulse output means.

22. An arrhythmia treatment system comprising:

sensor means adapted for implantation in a patient for sensing a physiological characteristic which exhibits a change upon the onset of cardiac arrhythmia and for generating an electrical signal corresponding to said physical characteristic;

means contained in a housing adapted for implantation in a patient and adapted to be connected in vivo to said sensor means to receive said electrical signal therefrom for generating a treatment initiation signal upon the onset of cardiac arrhythmia;

a voltage source in said housing;

means in said housing for charging a capacitance from said voltage source in response to said treatment initiation signal for generating a treatment pulse;

pulse output means connected to an output of said means for charging for releasing said treatment pulse after a time following said treatment initiation signal;

first telemetry transceiver means disposed in said housing and connected to said means for generating a treatment initiation signal for telemetrically transmitting a signal in response to said treatment initiation signal, and for receiving externally generated signals;

second telemetry transceiver means disposed externally of said patient for receiving said signal from said first telemetry transceiver means, and for transmitting signals to said first telemetry transceiver means;

alarm means disposed externally of said patient and connected to said second telemetry transceiver means for generating an alarm upon receipt of said signal from said first telemetry transceiver means for informing a patient in whom said housing is implanted that a treatment sequence has been initiated;

first logic means disposed externally of said patient and connected to said second telemetry transceiver means and optionally operable by said patient to generate an inhibit instruction after said patient has been informed that a treatment sequence has been initiated, said inhibit instruction being telemetrically transmitted from said second telemetry transceiver to said first telemetry transceiver; and

second logic means disposed in said housing and connected to said first telemetry receiver for preventing, in response to receipt of said inhibit instruction before elapse of said time, at least one of further charging of said capacitance by said means for charging or releasing of said treatment pulse by said pulse output means.

23. An arrhythmia treatment system comprising:

sensor means adapted for implantation in a patient for sensing a physiological characteristic which exhibits a change upon the onset of cardiac arrhythmia and for generating an electrical signal corresponding to said physical characteristic;

means contained in a housing adapted for implantation in a patient and adapted to be connected in vivo to said sensor means to receive said electrical signal therefrom for generating a treatment initiation signal upon the onset of cardiac arrhythmia;

a voltage source in said housing;

means in said housing for charging a capacitance from said voltage source in response to said treatment initiation signal for generating a treatment pulse;

pulse output means connected to an output of said means for charging for releasing said treatment pulse after a time following said treatment initiation signal;

alarm means connected to said means for generating said treatment initiation signal for receiving said signal therefrom for informing a patient in whom said housing is implanted that a treatment sequence has been initiated;

a magnetically actuated normally closed switch connected between said voltage source and said means for charging which switches to an open state in the presence of a magnetic field; and

a magnet manipulable by said patient after said patient has been informed by said alarm means that a treatment sequence has been initiated to place said magnetically actuated normally closed switch in the presence of a magnetic field generated by said magnet thereby to open said magnetically actuated normally closed switch to cease charging of said capacitance.

24. An arrhythmia treatment system comprising:

sensor means adapted for implantation in a patient for sensing a physiological characteristic which exhibits a change upon the onset of cardiac arrhythmia and for generating an electrical signal corresponding to said physical characteristic;

means contained in a housing adapted for implantation in a patient and adapted to be connected in vivo to said sensor means to receive said electrical signal therefrom for generating a treatment initiation signal upon the onset of cardiac arrhythmia;

a voltage source in said housing;

means in said housing for charging a capacitance from said voltage source in response to said treatment initiation signal for generating a treatment pulse;

pulse output means connected to an output of said means for charging for releasing said treatment pulse after a time following said treatment initiation signal;

telemetry transmitter means disposed in said housing and connected to said means for generating a treatment initiation signal for telemetrically transmitting a signal in response to said treatment initiation signal;

telemetry receiver means disposed externally of said patient for receiving said signal from said telemetry transmitter means;

alarm means disposed externally of said patient and connected to said telemetry receiver means for informing said patient that a treatment sequence has been initiated;

a magnetically actuated normally closed switch, connected in said housing between said voltage source and said means for charging, which switches to an open state in the presence of a magnetic field; and

a magnet manipulable by said patient after being informed that a treatment sequence has been initiated to optionally place said magnetically actuated normally closed switch in the presence of a magnetic field generated by said magnet to open said magnetically actuated normally closed switch to cease charging of said capacitance.

25. An arrhythmia treatment method comprising:

sensing a physiological characteristic of a patient which exhibits a change upon the onset of cardiac arrhythmia using a sensor implanted in said patient;

generating an electrical signal with said sensor corresponding to said physical characteristic;

generating, in response to said change in said physical characteristic, a signal in circuitry contained in a housing implanted in the patient which initiates an arrhythmia treatment sequence including generating and releasing a treatment pulse in vivo to said patient;

informing said patient, substantially simultaneously with the initiation of said arrhythmia treatment sequence, that said arrhythmia treatment sequence has been initiated; and

said patient, after being informed of the initiation of said arrhythmia treatment sequence, optionally communicating with circuitry in said housing to stop said arrhythmia treatment sequence before the release of said treatment pulse.

26. A method, as claimed in claim 25, wherein the step of informing said patient is further defined by informing said patient that an arrhythmia treatment sequence has been initiated by activating an alarm contained within said housing.

27. A method, as claimed in claim 26, wherein the step of said patient optionally stopping said arrhythmia treatment sequence is further defined by the steps of:

providing circuitry in said housing which stops said arrhythmia treatment sequence in the presence of a magnetic field; and

providing said patient with a magnet manipulable by said patient to place said circuitry in said housing in the presence of a magnetic field generated by said magnet to stop said arrhythmia treatment sequence.

28. A method, as claimed in claim 26, wherein the step of said patient optionally stopping said arrhythmia treatment sequence is further defined by the steps of:

said patient operating external logic circuitry to generate an inhibit instruction;

telemetrically transmitting said inhibit instruction to telemetry circuitry disposed in said housing; and

stopping said arrhythmia treatment sequence in said housing upon receipt of said inhibit instruction.

29. A method, as claimed in claim 25, wherein the step of informing said patient is further defined by the step of informing said patient that an arrhythmia treatment sequence has been initiated by activating an alarm externally of said patient.

30. A method, as claimed in claim 29, comprising the additional steps of:

generating a telemetry signal in said housing simultaneously with initiating said arrhythmia treatment sequence and telemetrically transmitting said signal; and

telemetrically receiving said signal externally of said patient and thereupon activating said external alarm.

31. A method, as claimed in claim 29, wherein the step of said patient optionally stopping said arrhythmia treatment sequence is further defined by the steps of:

providing circuitry in said housing which stops said arrhythmia treatment sequence in the presence of a magnetic field; and

providing said patient with a magnet manipulable by said patient to place said circuitry in said housing in the presence of a magnetic field generated by said magnet to stop said arrhythmia treatment sequence.

32. A method, as claimed in claim 29, wherein the step of said patient optionally stopping said arrhythmia treatment sequence is further defined by the steps of:

said patient operating external logic circuitry to generate an inhibit instruction;

telemetrically transmitting said inhibit instruction to telemetry circuitry disposed in said housing; and

stopping said arrhythmia treatment sequence in said housing upon receipt of said inhibit instruction.

33. An arrhythmia treatment method, as claimed in claim 25, wherein the step of generating a treatment pulse is further defined by charging a capacitance in said housing to a selected voltage and discharging said capacitance to generate said pulse.

34. A arrhythmia treatment method, as claimed in claim 33, comprising the additional steps of:

providing a dummy load in said housing; and

directing the discharge of said capacitance in said housing into said dummy load if said patient stops said arrhythmia treatment sequence.