Configurable arrhythmia analysis algorithm

• US 6,108,578 A
• Filed: 09/02/1998
• Issued: 08/22/2000
• Est. Priority Date: 09/02/1998
• Status: Expired due to Fees

• Current Assignee: Koninklijke Philips Electronics N.V. (Koninklijke Philips N.V.)
• Original Assignee: Heartstream, Inc. (HP Inc.)
• Inventors: Bardy, Gust H, Lyster, Thomas D.
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US09/146,059
• Time in Patent Office: 720 Days
• Field of Search: 607/5, 607/7, 607/30
• US Class Current: 607/5
• CPC Class Codes: A61N 1/3904 External heart defibrillators [EHD]

Abstract

An electrotherapy device includes a power supply and electrodes. The electrodes are coupled to the power supply to deliver a defibrillating shock to a patient. Electronic circuitry is coupled to the electrodes and is operable to detect heart rhythms via the electrodes. Further, control circuitry is coupled to the electronic circuitry and the power supply and configurable to selectively classify patient heart rhythms that generate a shockable condition, the control circuitry operable to arm the power supply for energizing the electrodes responsive to such detectable shockable condition. A method is also provided.

Claims

1. An external defibrillator, comprising:

a power supply;

electrodes coupled to the power supply and operable to deliver a defibrillating shock to a patient;

electronic circuitry coupled to the electrodes and operable to measure parameters of the patient'"'"'s heart rhythm via the electrodes; and

control circuitry coupled to the electronic circuitry and the power supply and operable to determine whether the patient'"'"'s heart rhythm is shockable based on the measured parameters and to arm the power supply for energizing the electrodes if the patient'"'"'s heart rhythm is shockable, the control circuitry being configurable for a device-use condition by adjustment of one of the following variables;

the absolute contribution of one of the parameters to the heart-rhythm determination,

the predetermined value to which one of the parameters is compared during the heart-rhythm determination, or

the relative contribution of one of the parameters to the heart-rhythm determination with respect to the contribution of another of the parameters to the heart-rhythm determination.

2. A device of claim 1 wherein the electronic circuitry comprises electrocardiogram (ECG) circuitry.

3. The electrotherapy device of claim 1 wherein the device-use condition comprises the skill level of an operator.

4. The electrotherapy device of claim 1 wherein the device-use condition comprises a defibrillation protocol.

5. An electrotherapy device, comprising:

a power supply;

electrodes coupled to the power supply to deliver a defibrillating shock to a patient;

electronic circuitry coupled to the electrodes and operable to detect heart rhythms via the electrodes;

control circuitry coupled to the electronic circuitry and the power supply and configurable to selectively classify patient heart rhythms that generate a shockable condition, the control circuitry operable to arm the power supply for energizing the electrodes responsive to detection of shockable-condition patient heart rhythms, the control circuitry including a reconfigurable classifier operable to associate a pre-selected set of parameters indicative of patient heart rhythm, each parameter having a range of values, the parameters associated such that a shock/no-shock decision is generated based upon measured parameter values and relative association between the parameters; and

an interface associated with the classifier and operable to enable reconfiguration of the classifier by personnel such that desired functionality is imparted through the device in association with the skill level and/or training of expected operators found within a specific deployment environment.

6. The device of claim 5 wherein the interface comprises a switch associated with the device.

7. The device of claim 5 wherein the interface comprises an encoded signal deliverable via the interface.

8. The device of claim 7 wherein the interface comprises an encoded electrode connector configured to couple with a pediatric electrode, coupling of the pediatric electrode with the encoded electrode connector operable to trigger the control circuitry to deliver a shock for a pediatric patient.

9. An electrotherapy device, comprising:

a power supply;

electrodes coupled to the power supply and operable to monitor a patent'"'"'s heart rhythm and to deliver a defibrillating shock to the patient;

ECG circuitry coupled to the electrodes and operable to detect the patient'"'"'s heart rhythm and to generate measured parameter values indicative of the patient'"'"'s heart rhythm;

a controller coupled to the ECG circuitry and the power supply and operable to enable shock delivery to the patient via the power supply responsive to the measured parameter values; and

a classifier associated with the controller and operable to make a shock/no-shock decision by analyzing the measured parameter values according to a defibrillation protocol, the classifier being reconfigurable to make a shock/no-shock decision by analyzing the measured parameters according to another defibrillation protocol.

10. The device of claim 9 wherein the parameters comprise a standard set of ECG measures.

11. The device of claim 10 wherein the classifier combines the standard set of ECG measures to produce a shock/no-shock decision.

12. The device of claim 9 wherein the measured parameter values comprise at least one of the following parameters:

heart rate, morphological stability of heart-rhythm complexes, and heart-conduction properties.

13. An electrotherapy device, comprising:

a power supply;

electrodes coupled to the power supply and operative to monitor a patent'"'"'s heart rhythms and deliver a defibrillating shock to a patient;

ECG circuitry coupled to the electrodes, and operative to detect patient heart rhythms and generate measured parameter values indicative of a patient heart rhythm;

a controller coupled to the ECG circuitry and the power supply and operative to enable shock delivery to a patient via the power supply responsive to the measured parameter values indicative of a detected patient heart rhythm;

a classifier associated with the controller and operative to associate a pre-selected set of parameters, each parameter having a predetermined range of values, to generate a shock/no-shock decision; and

a secure access interface associated with the classifier and operative to enable reconfiguration of the classifier by authorized personnel in a set-up mode of the electrotherapy device such that functionality of the electrotherapy device is imparted commensurate with the skill level/training of an operator to be encountered within a specific deployment environment.

14. The device of claim 13 wherein the secure access interface comprises a dip switch encased within a housing of the device at a location not readily accessible by an ordinary operator.

15. The device of claim 13 wherein the secure access interface comprises a password-protected configurable ECG operating setup.

16. The device of claim 13 wherein the classifier includes a predetermined set of associated parameters indicative of a borderline rhythm, the classifier parameters configurable through the secure access interface to generate a shock/no-shock decision based upon the skill/training of an expected operator found within the intended deployment environment for the device.

17. An electrotherapy device, comprising:

a power supply;

electrodes coupled to the power supply;

electronic circuitry coupled to the power supply and operable to monitor electrocardiographic (ECG) data signals, and adapted to deliver a defibrillation shock to a user'"'"'s body; and

a reconfigurable classifier coupled to the electronic circuitry and the power supply and operative to associate a pre-selected set of parameters, each parameter characterizing the ECG data signals, to generate a shock/no-shock decision, wherein the classifier comprises control circuitry, including a processor, and an algorithm operatively associated with the processor such that the classifier is reconfigurable by selectively associating and weighting a plurality of the pre-selected set of parameters.

18. The device of claim 17 further comprising an electrocardiogram (ECG) arrhythmia-analysis algorithm operatively associated with the electronic circuitry.

19. An electrotherapy device, comprising:

a power supply;

electrodes coupled to the power supply;

electronic circuitry coupled to the power supply and operable to monitor electrocardiographic (ECG) data signals, and adapted to deliver a defibrillation shock to a user'"'"'s body;

a reconfigurable classifier coupled to the electronic circuitry and the power supply and operative to associate a pre-selected set of parameters, each parameter characterizing the ECG data signals, to generate a shock/no-shock decision; and

a secure access interface associated with the classifier and operative to enable restricted access by control personnel to configure/reconfigure the classifier so as to tailor shock-delivery functionality of the device to an intended operator based upon the operator'"'"'s expected level of skill/training.

20. The device of claim 19 further comprising an electrocardiogram (ECG) arrhythmia-analysis algorithm operatively associated with the electronic circuitry.

21. A method for optimizing shock delivery from an external defibrillator to a patient, comprising:

defining parameters that characterize heart function;

accessing control circuitry, the control circuitry operative to implement a classifier defined by at least one of the parameters, the classifier operative to enable delivery of shock to a patient based upon detected values of at least one of the parameters relative to predetermined values of the at least one parameter; and

optimizing the classifier by adjusting at least one of;

a) the contribution of one or more of the parameters used to implement the classifier;

b) the predetermined values of one or more of the parameters used to implement the classifier that enables shock delivery; and

c) the relative contribution of one parameter relative to other parameters toward enabling shock delivery.

22. A method for optimizing shock delivery from a defibrillator to a patient according to claim 21 wherein the step of defining parameters comprises assigning a parameter to each of a standard set of ECG measures.

23. A method for optimizing shock delivery from the defibrillator to a patient according to claim 21 wherein the control circuitry is accessed via a secure access interface.

24. A method for optimizing shock delivery from a defibrillator to a patient according to claim 21 wherein the classifier comprises a plurality of associated parameters, each parameter having a detected value that is associated with predetermined values for the parameter, the classifier reconfigurable by adjusting association of the parameters.

25. A method for optimizing shock delivery from a defibrillator to a patient according to claim 21 wherein the accessing comprises defining the classifier by at least one of the following parameters:

heart rate, morphological stability of heart rhythm complexes, and heart-conduction properties.

26. A method for optimizing shock delivery from a defibrillator to a patient according to claim 21 wherein the optimizing the classifier comprises adjusting at least one of a), b), and c) according to the skill level of an intended operator of the defibrillator.

27. A method for optimizing shock delivery from a defibrillator to a patient according to claim 21 wherein the optimizing the classifier comprises adjusting at least one of a), b), and c) according to a defibrillation protocol.