Means and method for the detection of cardiac events

• US 7,558,623 B2
• Filed: 05/26/2004
• Issued: 07/07/2009
• Est. Priority Date: 09/20/2002
• Status: Expired due to Fees

• Current Assignee: Angel Medical Systems, Inc.
• Original Assignee: Angel Medical Systems, Inc.
• Inventors: Fischell, David R., Fischell, Robert E., Johnson, Steven R., Harwood, Jonathan, Fischell, Tim A.
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US10/853,058
• Publication Number:
  US 20040215092A1
• Time in Patent Office: 1,868 Days
• Field of Search: 600508-517
• US Class Current: 600/517
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/7465 Arrangements for interactive communication between patient and care services, e.g. by using a telephone network telemetry of measured physiological signal A61B5/0002
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/3702 Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

Disclosed is a system for the detection of cardiac events that includes an implanted device called a cardiosaver, a physician'"'"'s programmer and an external alarm system. The system is designed to provide early detection of cardiac events such as acute myocardial infarction or exercise induced myocardial ischemia caused by an increased heart rate or exertion. The system can also alert the patient with a less urgent alarm if a heart arrhythmia is detected. Using different algorithms, the cardiosaver can detect a change in the patient'"'"'s electrogram that is indicative of a cardiac event within five minutes after it occurs and then automatically warn the patient that the event is occurring. To provide this warning, the system includes an internal alarm sub-system (internal alarm means) within the cardiosaver and/or an external alarm system (external alarm means) which are activated after the ST segment of the electrogram exceeds a preset threshold.

Claims

1. A system for detecting a cardiac event in a human patient, the system including:

at least two electrodes implanted in the patient for obtaining the electrical signal from the patient'"'"'s heart, the electrical signal being an electrogram;

an implantable device having alerting means, the implantable device designed to process the electrogram at a first time period, thereby obtaining a reference value of a heart signal parameter, and to store the reference value of the heart signal parameter, and to detect a cardiac event by processing the electrogram at a second time that is at least twelve hours after the first time, the implantable device designed to categorize detected cardiac events into at least two different levels of severity, wherein a cardiac event associated with a relatively lower level of severity is based on the value of the heart signal parameter resulting from an elevated heart rate during a second time period as compared to the reference value of the heart signal parameter when measured at the first time period.

2. The system of claim 1 further including:

a remote diagnostic center designed to receive data messages and to send and receive voice telephone calls, the remote diagnostic center also designed to prioritize calls based on the level of severity of the detected cardiac event; and

an external alarm transceiver having two-way data communications with the implantable device, the two-way data communications including the ability of the external alarm transceiver to receive notification of a cardiac event detected by the implantable device, the notification including the level of severity of the cardiac event, the external alarm transceiver also having the capability for data communication with the remote diagnostic center, the data communication including data messages indicating the level of severity of the detected cardiac event.

3. The system of claim 1 where there are exactly two levels of severity for detected cardiac events.

4. The system of claim 1 where one level of severity is an EMERGENCY ALARM indicating that the patient should seek immediate medical attention.

5. The system of claim 1 where one level of severity is a SEE DOCTOR ALERT indicating that the patient should schedule an appointment with a medical practitioner as soon as convenient.

6. The system of claim 1 wherein the cardiac event associated with a relatively lower level of severity is chronic ischemia.

7. The system of claim 6 wherein the heart signal parameter pertains to the ST segment.

8. The system of claim 1 wherein the cardiac event associated with a relatively higher level of severity is acute ischemia.

9. A system for detecting a cardiac event in a human patient, the system including:

at least two skin surface electrodes for obtaining the electrical signal from the patient'"'"'s heart, the electrical signal being an electrocardiogram;

a detection device having patient alerting means, the detection device designed to detect a cardiac event by processing the electrical signal from the patient'"'"'s heart, the detection device designed to categorize detected cardiac events into at least two levels of severity, wherein a relatively higher level of severity event results in the generation of a patient alarm and wherein a relatively lower level of severity event results in an event specific response but does not result in the generation of a patient alarm, and wherein a cardiac event associated with a relatively lower level of severity is based on the value of the heart signal parameter resulting from an elevated heart rate during a second time period as compared to a reference value of the heart signal parameter when measured at a first time period.

10. The system of claim 9 further including:

a remote diagnostic center designed to receive data messages and to send and receive voice telephone calls, the remote diagnostic center also designed to prioritize calls based on the level of severity of the detected cardiac event; and

an external alarm transceiver having two-way data communications with the detection device, the two-way data communications including the ability of the external alarm transceiver to receive notification of a cardiac event detected by the detection device, the notification including the level of severity of the cardiac event, the external alarm transceiver also having the capability for data communication with the remote diagnostic center, the data communication including data messages indicating the level of severity of the detected cardiac event.

11. The system of claim 10 where the external alarm transceiver is incorporated into the detection device.

12. The system of claim 9 where there are exactly two levels of severity for detected cardiac events.

13. The system of claim 9 where one level of severity is an EMERGENCY ALARM indicating that the patient should seek immediate medical attention.

14. The system of claim 9 where one level of severity is a SEE DOCTOR ALERT indicating that the patient should schedule an appointment with a medical practitioner as soon as convenient.

15. The system of claim 10 wherein the detection device is adapted to be disposed externally to the patient.

16. A system for detecting a cardiac event in a human patient, the system including:

at least two electrodes implanted in the patient for obtaining the electrical signal from the patient'"'"'s heart, the electrical signal being an electrogram;

an implanted device having alerting means, the device designed to detect a cardiac event by processing the electrogram, the device designed to categorize detected cardiac events into relatively higher and lower levels of severity, wherein a relatively higher level of severity event results in the generation of a patient alarm and wherein a relatively lower level of severity event results in an event specific response but does not result in the generation of a patient alarm, and wherein a cardiac event associated with a relatively lower level of severity is based on the value of the heart signal parameter resulting from an elevated heart rate during a second time period as compared to a reference value of the heart signal parameter when measured at a first time period.

17. The system of claim 16 wherein the event specific response includes the storage of information regarding the relatively lower level of severity event.