Data collection and system management for patient-worn medical devices

• US 6,681,003 B2
• Filed: 07/16/2002
• Issued: 01/20/2004
• Est. Priority Date: 10/05/1999
• Status: Expired due to Term

• Current Assignee: Zoll Medical Corporation (Asahi Kasei Corporation)
• Original Assignee: Zoll Lifecor Corporation (Asahi Kasei Corporation)
• Inventors: Linder, Marshal, Kaib, Thomas
• Primary Examiner(s): WOO, STELLA L
• Application Number:
  US10/197,159
• Publication Number:
  US 20020181680A1
• Time in Patent Office: 553 Days
• Field of Search: 379/106.02, 379/106.01, 379/38, 379/37, 379/39, 379/110.01, 379/90.01
• US Class Current: 379/106.02
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: A61N 1/3904 External heart defibrillators [EHD]
• CPC Class Codes: A61N 1/3925 Monitoring; Protecting
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: G06F 8/65 Updates security arrangements therefor G06F21/57
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A method and system of monitoring information received from a patient-worn medical device is disclosed. A medical device, such as a portable or implantable device, collects patient and operational information, which information is transmitted to central location, such as a doctor'"'"'s office or device manufacturer'"'"'s location. The data collected can be analyzed to monitor both the patient health parameters as well as the operation of the device. Trend analysis can be performed in order for a physician to diagnose the patient'"'"'s health and a medical device technician can insure correct functioning of the device itself. Communication between the central location and the medical device is preferably done through a modem connection, and software and other updates can be automatically transmitted to the medical device during data download from the device to the central location. Physicians and technicians can access the central location from any home or office computer via the internet.

Claims

1. A method of monitoring patient medical information for the treatment of a patient, the method comprising the steps of:

providing a wearable medical device for monitoring patient medical information and treating the patient in response to a monitored medical condition;

operatively connecting the medical device to the patient such that the medical device is worn by the patient;

recording the patient medical information in a storage means of the medical device;

operatively connecting the medical device to a communications system;

transmitting the patient medical information to a health care provider by means of said communications system and recording the patient medical information in an information database; and

providing access to the patient medical information to individuals.

2. A method of monitoring patient medical information for the treatment of a patient, the method comprising the steps of:

providing a wearable medical device for treating the patient and monitoring patient medical information;

operatively connecting the medical device to the patient such that the medical device is worn by the patient;

recording the patient medical information, device performance data and patient compliance data in a storage means of the medical device;

operatively connecting the medical device to a communications system;

transmitting the patient medical information, device performance data and patient compliance data to a health care provider by means of said communications system and recording the patient medical information, device performance data and patient compliance data in an information database, wherein said transmitting step is performed while the medical device is operatively connected to the patient for providing treatment to the patient; and

providing access to the patient medical information, device performance data and patient compliance data to individuals.

3. The method as set forth in claim 2, wherein the medical device is a cardiac defibrillation device and the step of recording the patient medical information comprises recording electrocardiograms of the patient'"'"'s heart rhythm.

4. A system for monitoring patient medical information and providing treatment to a patient, the system comprising:

a wearable medical device for monitoring and storing medical parameters and treating the patient in response to a monitored medical condition, the medical device operatively attachable to the patient such that the medical device is worn by the patient;

a communications network;

means for connecting the medical device to the communication network;

a patient database;

means for monitoring and storing operations information of the medical device and patient compliance and use data;

means for connecting the patient database to the communication network; and

means for exchanging information between the medical device and the patient database, including means for transmitting the medical device operations information and the patient compliance and use data to the patient database via the communication network.

5. The system as recited in claim 4, further comprising means for monitoring an operating status of the medical device.

6. The system as recited in claim 5 wherein the medical device is a cardiac defibrillator and said medical parameters include at least partial electro-cardiogram (ECG) data.

7. The system as recited in claim 4, wherein the medical device is a wearable cardio-defibrillator.

8. The system as recited in claim 4, wherein said means for exchanging information includes means for transmitting patient medical information from the medical device to the patient database.

9. The system as recited in claim 4, wherein said means for monitoring operations information includes means for monitoring battery status for a battery of the medical device.

10. The system as recited in claim 6, further comprising means for storing operating status information of the cardiac defibrillator and wherein said means for exchanging information includes means for transmitting operating status information to the patient database via the communication network.

11. The system as recited in claim 10 wherein said means for monitoring operating status information includes means for monitoring battery status for a battery of the medical device.

12. The system as recited in claim 11 wherein said means for monitoring operating status information further includes means for transmitting the operating status information to the patient database.

13. The system as recited in claim 12, wherein said operating status information includes one or more of battery capacity, system memory, patient device utilization and system noise.

14. The system as recited in claim 13, further including means for analyzing said operating status information.

15. The system as recited in claim 14, further including means for transmitting parameter update information to the medical device based on said analysis of the operating status information.

16. The system as recited in claim 8, further including means for accessing the patient database via the communication network, wherein medical personnel can analyze the patient medical information from a remote location.

17. The system as recited in claim 10, further including means for accessing the patient database via the communication network, such that technical personnel can analyze said operating status information.

18. The system as recited in claim 17, wherein said operating status information includes one or more of patient wear data for the cardiac defibrillator, alarm indicators, and ECG signal information.

19. A system for monitoring patient medical information and providing treatment to a patient, the system comprising:

a wearable medical device for monitoring and storing medical parameters and treating the patient in response to a monitored medical condition, the medical device operatively attachable to the patient such that the medical device is worn by the patient;

a communications network;

means for connecting the medical device to the communication network;

a patient database;

means for connecting the patient database to the communication network;

means for monitoring and storing patient medical parameters, device performance data and patient compliance data;

means for exchanging information between the medical device and the patient database, including means for transmitting the patient medical parameters, device performance data and patient compliance data to the patient database via the communications network; and

means for downloading device parameter software to the medical device from the communications network.

20. The system as recited in claim 19, wherein the device parameter software includes one or more of operations upgrade software, patient compliance guidelines or product maintenance information.

21. A system for monitoring patient medical information and providing treatment to a patient, the system comprising:

a wearable cardiac defibrillator for collecting and storing electro-cardiogram (ECG) data and treating the patient in response to the collected ECG data, the cardiac defibrillator operatively attachable to the patient such that the cardiac defibrillator is worn by the patient;

a communications network;

means for connecting the cardiac defibrillator to the communication network;

a patient database;

means for connecting the patient database to the communication network;

means for monitoring and storing patient medical parameters, device performance data and patient compliance data;

means for exchanging information between the cardiac defibrillator and the patient database, including means for transmitting the patient medical parameters, device performance data and patient compliance data to the patient database via the communications network, and means for transmitting instructions on proper use and operation of the cardiac defibrillator to the patient via the communications network; and

means for downloading software to the cardiac defibrillator from the communications network.

22. A system for monitoring patient medical information and providing treatment to a patient, the system comprising:

a wearable cardiac defibrillator for collecting and storing electro-cardiogram (ECG) data and treating the patient in response to the collected ECG data, the cardiac defibrillator operatively attachable to the patient such that the cardiac defibrillator is worn by the patient;

a communications network;

means for connecting the cardiac defibrillator to the communication network;

a patient database;

means for connecting the patient database to the communication network;

means for exchanging information between the cardiac defibrillator and the patient database; and

means for downloading instructions for proper operation of the cardiac defibrillator to a patient wearing the cardiac defibrillator via the communications network.

23. The system as recited in claim 22, wherein said means for connecting the cardiac defibrillator to the communications network comprises a base station having a modem for accessing the communications network and a transcutaneous informational transmission device operably associated with the base station for communication with the cardiac defibrillator.

24. The system as recited in claim 22, further comprising means for monitoring an operating status of the cardiac defibrillator.

25. The system as recited in claim 22, wherein said means for exchanging information includes means for transmitting patient medical information from the cardiac defibrillator to the patient database.

26. The system as recited in claim 22, wherein said means for monitoring operations information includes means for monitoring battery status for a battery of the cardiac defibrillator.

27. The system as recited in claim 24, further comprising means for storing operating status information of the cardiac defibrillator and wherein said means for exchanging information includes means for transmitting operating status information to the patient database via the communication network.

28. The system as recited in claim 27 wherein said means for monitoring operating status information includes means for monitoring battery status for a battery of the cardiac defibrillator.

29. The system as recited in claim 28 wherein said means for monitoring operating status information further includes means for transmitting the operating status information to the patient database.

30. The system as recited in claim 29 wherein said operating status information includes one or more of battery capacity, system memory, patient device utilization and system noise.

31. The system as recited in claim 30, further including means for analyzing said operating status information.

32. The system as recited in claim 31, further including means for transmitting parameter update information to the cardiac defibrillator based on said analysis of the operating status information.

33. The system as recited in claim 25, further including means for accessing the patient database via the communication network, wherein medical personnel can analyze the patient medical information from a remote location.

34. The system as recited in claim 27, further including means for accessing the patient database via the communication network, such that technical personnel can analyze said operating status information.

35. The system as recited in claim 34, wherein said operating status information includes one or more of patient wear data for the cardiac defibrillator, alarm indicators, and ECG signal information.