Method and system for collecting data on a plurality of patients

• US 20060167367A1
• Filed: 12/21/2005
• Published: 07/27/2006
• Est. Priority Date: 12/23/2004
• Status: Abandoned Application

• Current Assignee: Epiphany Cardiography Products, LLC
• Original Assignee: Epiphany Cardiography Products, LLC
• Inventors: Deremer, Russell, Stanczak, James
• Application Number:
  US11/313,491
• Publication Number:
  US 20060167367A1
• Time in Patent Office: Days
• US Class Current: 600/523
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires

Abstract

A system and a method for recording data from one or more persons is provided. The system generally comprises a recording device for recording data from each person, a processing unit for storing and analyzing the recorded data, and one or more output devices for displaying or printing the data and/or the results of the analysis. The method provides steps for recording and analyzing the data from the one or more persons.

Claims

1. A method for gathering physiological data from a plurality of patients, the method comprising the steps of:

providing a discrete recording device for each of the plurality of patients;

associating each discrete recording device with its respective assigned patient;

connecting each recording device to its associated patient;

recording onto the recording device physiological data from its respective patient;

transmitting the physiological data between a processing unit and each recording device; and

storing the transmitted data.

2. The method of claim 1 further comprising the step of programming each of the recording devices with one or more parameters.

3. The method claim 2 wherein the programming step includes defining a test protocol.

4. The method of claim 3 wherein the defining a test protocol step includes setting a recording start time.

5. The method of claim 4 wherein each recording device is programmed with and begins the recording step at the same recording start time.

6. The method of claim 4 wherein the defining a test protocol step further includes defining a duration for the test.

7. The method of claim 4 wherein the defining a test protocol step further includes defining one or more times for alerting any one patient to perform some event.

8. The method of claim 7 further comprising the step of alerting any one patient associated with any one of the respective recording devices.

9. The method of claim 8 wherein the alert is provided simultaneously to each of the patients.

10. The method of claim 8 wherein the respective recording device provides the alert.

11. The method of claim 2 wherein the programming step further includes defining one or more times certain for a scheduled transmission of physiological data from the recording device to the processing unit during the transmitting step or steps.

12. The method of claim 3 wherein the defining a test protocol step further includes defining one or more physiological symptoms of interest.

13. The method of claim 12 wherein the defining a test protocol step includes defining which of the one or more physiological symptoms of interest will signal an unscheduled transmission of physiological data from the recording device to the processing unit.

14. The method of claim 13 wherein the patient initiates the transmitting step in response to one of the symptoms of interest.

15. The method of claim 2 wherein the programming step further includes entering patient demographics.

16. The method of claim 15 wherein the entering patient demographics step includes entering the demographics information of each of the plurality of patients.

17. The method of claim 2 wherein the programming step further includes specifying the resolution of a medical measuring device in communication with a respective recording device and used to measure one or more physiological parameters that make up the physiological data.

18. The method of claim 17 wherein the medical measuring device comprises an electrocardiogram (ECG) device coupled to the recording device and wherein the specifying step further includes specifying the resolution of the ECG.

19. The method of claim 2 further comprising the step of providing secure access to the recording device.

20. The method of claim 19 wherein the providing secure access step includes using an authentication device to control access.

21. The method of claim 2 further including the step of transmitting to the recording device the parameters entered into the processing unit during the programming step.

22. The method of claim 2 wherein each processing unit and each recording device can both transmit and receive signals between one another.

23. The method of claim 22 wherein the signals transmitted between the recording device(s) and the processing unit are transmitted using any suitable wireless or hardwire transmission technique.

24. The method of claim 23 wherein the processing unit comprises a network of processing units.

25. The method of claim 2 wherein the connecting step includes connecting to each respective patient one or more monitoring electrodes of the ECG device.

26. The method of claim 25 further comprising the step of determining the status of the recording device.

27. The method claim 26 wherein the determining the status step comprises:

transmitting parameters from the processing unit to each recording device;

evaluating the readiness of each respective recording device;

determining the signal quality of the electrodes;

providing an alarm if an abnormal condition is detected in the recording device, the ECG device, the electrodes, and/or communications between any of the processing unit, the recording device, the ECG device and the electrodes; and

transmitting from each recording device to the processing unit a ready to proceed signal.

28. The method of claim 27 further comprising the step of displaying on a display screen of the recording device certain of the parameters transmitted from the processing unit, wherein the displayed parameters may include for a respective recording device its associated patient'"'"'s name, its patient'"'"'s identification number, the protocol being used, medication administered to the patient, current date, current time, and a symptom list.

29. The method of claim 25 wherein the recording step comprises the steps of:

entering patient data into the recording device;

reading continuous ECG clinical data received from the electrodes;

converting an analog signal from the electrodes to a digital signal;

displaying on the recording device the ECG data; and

storing for a minimum of 24 hours the entered patient data and the ECG data in any suitable storage medium.

30. The method of claim 2 wherein the transmitting step comprises transmitting between the recording device and the processing unit one or more of the following:

physiological data, patient events information, interaction logs, performance status of the recording device, performance status of the processing unit, transmission schedules or any other data recorded, stored or displayed on either the recording device or the processing unit.

31. The method of claim 2 further comprising the step of directing at a predetermined time defined by the protocol the patient to perform an event.

32. The method of claim 2 wherein the storing step includes storing on any suitable medium coupled to the processing unit the data transmitted from the recording device.

33. The method of claim 32 further comprising the step of analyzing the stored data which includes the steps of:

retrieving the stored data;

viewing the retrieved data on an output device;

selecting the data to be analyzed; and

performing the analysis of the selected data.

34. The method of claim 33 wherein the analysis performing step comprises taking manual measurements of the ECGs.

35. The method of claim 33 wherein the analysis performing step comprises applying an automated interpretive algorithm to the selected data.

36. The method of claim 33 wherein the analysis performing step comprises:

converting the data to XML format; and

exporting the converted data to a third-party processing unit for analysis by an automated third-party algorithm.

37. The method of claim 33 wherein the analyzing step further comprises the steps of:

generating a file of unconfirmed ECGs not associated with a patient;

confirming the unconfirmed ECGs by collating them with patient entered data; and

performing the analysis on the confirmed ECGs.

38. The method of claim 33 further comprising the steps of:

editing the analysis;

acting on the analysis as defined by the protocol; and

storing the results of the analysis.

39. The method of claim 38 further comprising the steps of:

retrieving the stored data and/or the stored analysis;

mining the stored data and/or the stored analysis;

transmitting the stored data and/or analysis to one or more third-party.

40. The method of claim 2 wherein the method is compliant with defined government standards.

41. The method of claim 40 wherein the defined standard is 21 C.F.R. §

11 extant on Dec. 20, 2005.

42. A system for gathering physiological data from a plurality of patients, the system comprising:

a discrete recording device associated with each of a plurality of patients;

a sensor coupled to each recording device, the sensor configured to gather physiological data from the patient; and

a processing unit in two-way communication with each of the recording devices;

wherein each discrete recording device is configured to continuously receive, store, display, analyze and transmit physiological data gathered from its associated patient; and

wherein the processing unit is configured to receive, store, output, and analyze the data transmitted by each recording device.

43. The system of claim 42 wherein each discrete recording device and the processing unit each comprises one or more displays capable of displaying the physiological data in a user selectable format.

44. The system of claim 43 wherein the physiological data includes ECG data and the one or more displays is capable of displaying the data in a user selectable format chosen from the list comprising 3-lead, 6-lead, 12-lead and freeze formats.

45. The system of claim 43 further comprising storage media capable of continuous recording of ECG data for at least about 24 hours.

46. The system of claim 43 wherein each recording device further comprises:

an analog to digital converter;

a clock;

control software;

a diagnostic system;

an alarm system;

one or more control keys; and

a security system.

47. The system of claim 46 wherein the alarm system is responsive to an abnormal condition determined by the self-test algorithm.

48. The system of claim 46 wherein the alarm system is responsive to the occurrence of a predefined event.

49. The system of claim 46 wherein each display is configured to display certain patient data including the patient'"'"'s name, the patient'"'"'s identification number, the patient'"'"'s medicine, the patient'"'"'s test protocol, the current date, and the current time.

50. The system of claim 46 wherein the security system controls access to the system.

51. The system of claim 46 wherein the sensor comprises one or more electrodes coupled each recording device.

52. The system of claim 46 wherein the resolution of each sensor is adjustable.

53. The system of claim 46 further comprising one or more peripheral devices coupled to the processing unit.

54. The system of claim 53 wherein the one or more peripheral devices is an output device selected from the group consisting of a display, a printer, and a storage device.

55. The system of claim 54 wherein the printer is an impact printer, a laser printer or an inkjet printer.

56. The system of claim 53 wherein the one or more peripheral devices is an input device selected from the group consisting of a keyboard, a scanner, and a mouse.

57. The system of claim 46 wherein each recording device and the processing unit are coupled together by any suitable means.

58. The system of claim 46 wherein each recording device and the processing unit are coupled together by hardwire.

59. The system of claim 46 wherein each recording device and the processing unit are coupled together by a wireless communications network.

60. The system of claim 43 wherein the processing unit comprising means for:

entering protocols;

synchronizing the clocks of the processing unit and each recording device;

assigning each discrete recording device to each patient;

inputting patient data;

providing secure access control;

determining transmission schedules;

providing two-way communications with each recording device;

analyzing gathered and inputted data;

storing the analysis; and

exporting the analysis and the data.

61. The system of claim 43 further comprising one or more additional processing units networked together with said first processing unit.

62. The system of claim 43 wherein the entire system is 21 CFR §

11 compliant.

63. A system for gathering physiological data from a plurality of patients, the system comprising:

a discrete recording device associated with each of a plurality of patients, each recording device including;

an analog to digital converter;

a clock;

control software;

a diagnostic system;

an alarm system;

a display;

one or more control keys; and

a security system

a sensor coupled to each recording device, the sensor comprising one or more electrodes configured to gather physiological data from the patient; and

a processing unit in two-way communication with each of the recording devices, the processing unit including

a processing unit clock;

processing unit control and analysis software;

a processing unit diagnostic system;

a processing unit display;

a processing unit printer; and

a processing unit security system;

wherein each discrete recording device is configured to continuously receive, store, display, analyze and transmit physiological data gathered from its associated patient; and

wherein the processing unit is configured to receive, store, output, and analyze the data transmitted by each recording device.