Automatic external cardioverter/defibrillator

• US 5,474,574 A
• Filed: 06/24/1992
• Issued: 12/12/1995
• Est. Priority Date: 06/24/1992
• Status: Expired due to Term

• Current Assignee: Cardiac Science Operating Company (Cardica Incorporated)
• Original Assignee: Cardiac Science Operating Company (Cardica Incorporated)
• Inventors: Mathur, Prabodh, Brodsky, Michael A., Yeik, Glenn D., Saadatmanesh, Vahid, Cooper, Howard K., Seemann, Joseph P., Payne, Errol G.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US07/903,671
• Time in Patent Office: 1,266 Days
• Field of Search: 607/4, 607/5, 607/6, 607/7, 607/8
• US Class Current: 607/7
• CPC Class Codes: A61N 1/3931 Protecting, e.g. back-up systems

Abstract

A cardiac monitoring and defibrillation system is provided which may be embodied as a bedside unit or as an ambulatory unit. The system includes amplification and processing circuitry which receives and conditions inputs from a variety of sensing means such as an electrocardiogram, a blood oxygenation sensor, a blood pressure monitor, and a cardiac acoustical transducer. A noise and artifact discrimination procedure is employed to prevent erroneous detection of the onset of cardiac arrhythmias. In response to the conditioned inputs from the monitoring means, the microprocessor controls therapeutic electrical stimulus which may be delivered to a patient in accordance with a cardioverter/defibrillator step therapy method. The microprocessor may be operated or programmed by means of a control panel or an external programming and monitoring unit. In one embodiment, the system includes a bidirectional communication link which allows the microprocessor to be monitored and programmed by a physician at a remote location. Furthermore, the system provides a method for detecting cardiac arrhythmias and distinguishing between the different types of arrhythmias which may be detected.

Claims

1. A programmable external cardioverter/defibrillator device for automatically detecting cardiac arrhythmias and administering therapy, said device effectively discriminating between signals received from a patient that represent the actual condition of a patient'"'"'s heart and signal noise or artifact, said system being further adaptable in detection and therapy from patient to patient, said system comprising:

at least one external sensor, said sensor detecting cardiac signals from outside of the body of the patient and producing a detection signal representing said cardiac signals;

a signal noise and artifact discrimination controller connected to receive said detection signal, wherein said controller filters noise and artifact from the detection signal and generates a filtered detection signal so that the system can accurately detect the actual condition of the patient'"'"'s heart;

programmable control circuitry having an alterable parameter memory adapted to receive and store vital parameters which are changeable by an operator, said control circuitry further having processing logic coupled to said parameter memory and to said signal noise and artifact discrimination controller, wherein said processing logic receives said filtered detection signal and is responsive to said filtered detection signal and the parameters in said parameter memory to automatically detect and identify types of cardiac arrhythmias, said processing logic further automatically selecting a first predetermined energy to be delivered for electrical therapy when a life-threatening arrhythmia is detected, wherein said first predetermined energy is selected based upon the type of arrhythmia identified, said processing logic further monitoring the filtered detection signal for a time interval sufficient to determine if cardioversion or defibrillation has occurred after said first predetermined energy has been delivered to said patient, and automatically selecting and delivering a second predetermined energy having a level at least equal to a level of said first predetermined energy if cardioversion or defibrillation has not occurred, wherein said processing logic generates control signals indicating the energy level when an arrhythmia has been detected; and

cardioverter/defibrillator circuitry coupled to said processing logic and to said at least two energy delivery electrodes, wherein said cardioverter/defibrillator circuitry is responsive to said control signals received from said processing logic to automatically deliver therapeutic electrical stimuli via said energy delivery electrodes at the first predetermined energy when an arrhythmia has been detected, and at said second predetermined energy when an arrhythmia persists after delivery of said first predetermined energy.

2. A programmable external cardioverter/defibrillator device for automatically detecting cardiac arrhythmias and administering therapy, said device effectively discriminating between signals received from a patient that represent the actual condition of a patient'"'"'s heart and signal noise or artifact, said system being further adaptable in detection and therapy from patient to patient, said system comprising:

at least one external sensor which detects cardiac signals from outside of the body of the patient and produces a detection signal representing said cardiac signals;

signal noise and artifact discrimination circuitry and control connected to said at least one external sensor to filter noise and artifact from the detection signal, wherein said signal noise and artifact discrimination circuitry and control generates a filtered detection signal so that the system can accurately detect the actual condition of the patient'"'"'s heart;

programmable control circuitry having an alterable parameter memory adapted to receive and store vital parameters which are changeable by an operator, said control circuitry further having processing logic coupled to said parameter memory and to said signal noise and artifact discrimination circuitry and control, wherein said processing logic receives said filtered detection signal and is responsive to said filtered detection signal and the parameters in said parameter memory to detect arrhythmias and to produce control signals indicating whether an arrhythmia has been detected;

cardioverter/defibrillator circuitry connected to said processing logic, wherein said cardioverter/defibrillator circuitry is responsive to said control signals to automatically generate therapeutic electrical stimuli at varying levels of intensity when a life threatening arrhythmia has been detected by said processing logic; and

at least two energy delivery electrodes coupled to said cardioverter/defibrillator circuitry to deliver the therapeutic electrical stimuli at varying levels.

3. The external cardioverter/defibrillator device of claim 2, further comprising external programming means for programming and modifying said vital parameters, said external programming means coupled to said programmable control circuitry.

4. The external cardioverter/defibrillator device of claim 2, wherein the processing logic includes at least one counter for monitoring a number of heart beats which occur during a predetermined time interval, wherein said processing logic identifies the type of arrhythmia when an arrhythmia is detected based upon the number of beats counted.

5. The external cardioverter/defibrillator device of claim 2, further comprising a drug infusion pump coupled to said patient and to said programmable control circuitry, wherein said drug infusion pump is responsive to said control signals to administer therapeutic drugs to said patient.

8. A method for effecting therapeutic cardioversion or defibrillation of a cardiac arrhythmia using a programmable external cardioverter/defibrillator as defined in claim 4, said method comprising the steps of:

applying said at least one external sensor to the body of said patient;

externally applying said at least two energy delivery electrodes to said patient;

monitoring said filtered detection signal generated by said signal noise and artifact discrimination circuitry to automatically detect and identify the cardiac arrhythmia;

automatically selecting a first predetermined energy to be delivered for electrical therapy based upon the type of the arrhythmia detected;

producing a control signal indicating that an arrhythmia has been detected, wherein said cardioverter/defibrillator circuitry is responsive to said control signal to automatically apply an electrical stimulus through the energy delivery electrodes to deliver said first predetermined energy to said patient via said at least two energy delivery electrodes;

monitoring the filtered detection signal for a time interval sufficient to determine if cardioversion or defibrillation has occurred after delivery of said electrical stimulus; and

if said first predetermined energy level is not less than a maximum predetermined energy level, and if cardioversion or defibrillation has not occurred, selecting a subsequent predetermined energy level at least equal to said first predetermined energy level and repeating said applying and monitoring steps with said subsequent predetermined energy level.

9. The method of claim 8, further comprising the steps of:

determining the impedance between the at least two energy delivery electrodes; and

adjusting a selected voltage level to be applied as the electrical stimulus across said energy delivery electrodes in response to said determined impedance so that the voltage applied delivers the first predetermined energy level and the subsequent predetermined energy level.

10. The method of claim 8, further comprising the steps of:

if cardioversion or defibrillation has not occurred, with said cardioverter/defibrillator, repeatedly and automatically selecting an additional predetermined energy having a level at least equal to said first predetermined energy level and repeating said applying and monitoring steps with said additional predetermined energy level until cardioversion or defibrillation has occurred or until the additional predetermined energy equals the maximum predetermined energy; and

when said additional predetermined energy equals the maximum predetermined energy, repeating said applying and monitoring steps with the maximum predetermined energy until cardioversion or defibrillation has occurred or until a maximum number of therapies have been delivered.

6. A programmable external abnormal heart rhythm treatment device for automatically detecting cardiac arrhythmias and administering corrective therapy, said device being adaptable in the detection of arrhythmias and the administered treatment, said device comprising:

at least one external sensor for detecting cardiac signals outside of the body of the patient and producing a detection signal representing said cardiac signals;

signal noise and artifact discrimination circuitry and control connected to said at least one external sensor to filter noise and artifact from the detection signal., wherein said signal noise and artifact discrimination circuitry and control generates a filtered detection signal so that the system can accurately detect the actual condition of the patient'"'"'s heart;

programmable control circuitry having an alterable parameter memory adapted to receive and store vital parameters which are changeable by an operator, said control circuitry further having processing logic coupled to said parameter memory and to said at least one sensor, wherein said processing logic receives said detection signal and is responsive to said detection signal and the parameters in said parameter memory to produce control signals indicating whether an arrhythmia has been detected; and

a drug therapy infusion pump coupled to said programmable control circuitry and responsive to said control signals to infuse therapeutic drugs to said patient when an arrhythmia has been detected.

7. The programmable external abnormal heart rhythm treatment device of claim 6, wherein the control signals received from the control circuitry further indicate the dosage of said therapeutic drugs to be delivered to said patient.

11. A method for treating cardiac arrhythmias using the programmable external abnormal heart rhythm treatment device defined in claim 6, said method comprising the steps of:

applying said at least one external sensor to the body of said patient;

connecting said infusion pump to said patient;

monitoring said detection signal to automatically detect and identify the cardiac arrhythmia;

producing a control signal indicating that an arrhythmia has been detected, wherein said infusion pump is responsive to said control signal to to deliver a first dosage of drug therapy to a patient based upon the type of arrhythmia detected;

monitoring the detection signal for a time interval sufficient to determine if a return to a non-treatable rhythm has occurred after delivery of said drug therapy; and

if said first dosage is not less than a maximum dosage level, and if return to a non-treatable rhythm has not occurred, selecting a subsequent dosage level greater than said first dosage level and repeating said activating and monitoring steps with said subsequent dosage level.

12. A method for effecting therapeutic cardioversion or defibrillation of a cardiac arrhythmia using an external cardioverter/defibrillator device, said method comprising the steps of:

applying said at least one external sensor to the body of said patient;

externally applying said energy delivery electrodes to the body of said patient;

monitoring said detection signal produced by said at least one sensor to automatically detect and identify the cardiac arrhythmia;

automatically selecting a first predetermined energy to be delivered for electrical therapy based upon the type of the arrhythmia detected;

generating a control signal indicating that an arrhythmia has been detected, wherein said cardioverter/defibrillator circuitry is responsive to said control signal to automatically apply an electrical stimulus through the energy delivery electrodes to deliver said first predetermined energy to said patient via said at least two energy delivery electrodes.

13. The method of claim 12, further comprising the steps of:

monitoring the detection signal for a time interval sufficient to determine if cardioversion or defibrillation has occurred after delivery of said electrical stimulus; and

if said first predetermined energy level is less than a maximum predetermined energy level, and if cardioversion or defibrillation has not occurred, selecting a subsequent predetermined energy level at least equal to said first predetermined energy level and repeating said applying and monitoring steps with said subsequent predetermined energy level.

14. An external cardioverter/defibrillator device for automatically detecting cardiac arrhythmias and administering therapy to a patient, said device effectively discriminating between signals received from a patient that represent the actual condition of a patient'"'"'s heart and signal noise or artifact, said system comprising:

at least one external sensor for detecting cardiac signals from outside of the body of the patient and producing a detection signal representing said cardiac signals;

programmable control circuitry having an alterable parameter memory adapted to receive and store vital parameters which are changeable by an operator, said control circuitry further having processing logic coupled to said parameter memory and to said at least one external sensor, wherein said processing logic is responsive to said detection signal and the parameters in said parameter memory to automatically detect and identify types of cardiac arrhythmias, said processing logic further automatically selecting a first predetermined energy to be delivered for electrical therapy when a life-threatening arrhythmia is detected, wherein said first predetermined energy is selected based upon the type of arrhythmia identified, said processing logic further monitoring the detection signal for a time interval sufficient to determine if cardioversion or defibrillation has occurred after said first predetermined energy has been delivered to said patient and automatically selecting and delivering a second predetermined energy having a level at least equal to a level of said first predetermined energy if cardioversion or defibrillation has not occurred, wherein said processing logic generates control signals indicating the energy level when an arrhythmia has been detected; and

cardioverter/defibrillator circuitry coupled to said processing logic and at least two energy delivery electrodes, wherein said cardioverter/defibrillator circuitry is responsive to said control signals received from said processing logic to automatically deliver therapeutic electrical stimuli via said energy delivery electrodes at the first predetermined energy when an arrhythmia has been detected and at said second predetermined energy when an arrhythmia persists after delivery of said first predetermined energy.