Secure patient data recorder for recording monitored vital sign data

• US 8,882,663 B1
• Filed: 11/14/2008
• Issued: 11/11/2014
• Est. Priority Date: 04/29/2002
• Status: Active Grant

• Current Assignee: Guardian Dynamics, LLC
• Original Assignee: Guardian Dynamics, LLC
• Inventors: Tucker, Peter L.
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): JIAN, SHIRLEY XUEYING
• Application Number:
  US12/270,862
• Time in Patent Office: 2,188 Days
• Field of Search: None
• US Class Current: 600/300
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 2560/0475 Special features of memory means, e.g. removable memory cards
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: G06F 3/14 Digital output to display device ; Cooperation and interconnection of the display device with other functional units
• CPC Class Codes: G06T 11/206 Drawing of charts or graphs
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: Y10S 128/92 Computer assisted medical diagnostics

Abstract

A monitor and recorder system having a monitor unit for gathering vital sign data from a patient and a memory module for automatically recording the data. Means are provided for protecting the data from accidental or intentional deletion of the data or corruption or damage to the memory module without proper authorization. The data is recorded in a circular memory such that when data must be deleted, the last-recorded data is deleted first. A procedure is disclosed for preserving all data for at least a minimal period of time in case an event such as a patient death occurs.

Claims

1. A method of preserving patient vital sign data in a health care facility, comprising the procedure of:

defining, in a recording medium in a memory module, an addressable memory space for recording data representing vital sign information from a patient;

based on the size of the defined addressable memory space, determining a minimum period of time that a monitor unit may be operated to continuously and repeatedly gather data representative of vital sign information from one or more patients and to record the repeatedly-gathered data in the defined addressable memory space, when the memory module is communicatively connected to the monitor unit, without exceeding the capacity of the defined addressable memory space;

defining a minimum period of time for recorded vital sign data to be semi-permanently retained after operation of the monitor unit is discontinued, the defined minimum being at least as great as the determined minimum period of time;

initiating a new operational period, the operational period being no more than the determined minimum period of time;

with the memory module communicatively connected to the monitor unit, operating the monitor unit to continuously and repeatedly gather data representative of vital sign information from one or more patients and to record the repeatedly-gathered data in the defined addressable memory space, wherein operating the monitor unit to record the repeatedly-gathered data includes preventing the data recorded previously during the operational period from being overwritten, wherein the beginning of the continuously and repeatedly gathering data step defines the beginning of the operational period;

by the end of the determined minimum period of time, discontinuing the continuously and repeatedly gathering step, wherein the discontinuance defines the end of the operational period; and

after the discontinuing step, semi-permanently retaining, for at least the defined period of semi-permanent retention, substantially all of the vital sign data that has been gathered and stored in the recording medium since the beginning of the operational period; and

thereafter, repeating the initiating, operating, discontinuing and retaining steps.

2. The method of claim 1, further comprising the step of providing a bedside monitor unit having an electronic display device that displays a graphical representation of the vital sign data as it is gathered from the patient, and wherein the bedside monitor unit is the monitor unit utilized in the gathering step.

3. The method of claim 2, wherein the step of defining, in a recording medium, includes defining the addressable memory space in a non-volatile memory device.

4. The method of claim 2, further comprising semi-permanently retaining, in the recording medium, substantially all of the vital sign data that is stored in the recording medium at the time the gathering step is discontinued.

5. The method of claim 4, wherein the step of semi-permanently retaining substantially all of the vital sign data includes the step of preventing unauthorized deletion, from the recording medium, of any of the vital sign data that is stored in the recording medium at the time the gathering step is discontinued until an input, representative of an authorization to delete, is received by the memory module.

6. The method of claim 2, wherein the step of semi-permanently retaining substantially all of the vital sign data includes the step of preventing unauthorized deletion, from the recording medium, of any of the vital sign data that has been gathered and stored in the recording medium since the beginning of the operational period until an input, representative of an authorization to delete, is received by the memory module.

7. The method of claim 6, further comprising the step of, upon receiving the authorization input, erasing substantially all of the defined memory space.

8. The method of claim 6, further comprising the step of, upon receiving the authorization input, permitting the data retained in the defined memory space to be overwritten.

9. The method of claim 2, wherein the step of providing a bedside monitor unit includes providing a modular monitor unit having a plurality of module interfaces for connecting monitor modules to the bedside monitor unit.

10. The method of claim 9, wherein the step of providing a bedside monitor unit includes providing at least one monitor module, having a sensing device connected thereto, for connection to the bedside monitor unit via one of the plurality of module interfaces.

11. The method of claim 2, wherein the retaining step includes removing the recording medium from the memory module and storing the removed recording medium in a secure location.

12. The method of claim 2, further comprising the step of providing the memory module in patient data recorder, wherein the retaining step includes removing the memory module from the patient data recorder and storing the removed memory module in a secure location.

13. The method of claim 2, wherein the initiating, operating, discontinuing and retaining steps are repeated regularly on a periodic basis.

14. The method of claim 13, wherein the frequency of the repeated steps is chosen such that the available memory space in the recording medium of the memory module is never completely exhausted.

15. The method of claim 2, wherein the step of defining, in a recording medium, includes defining the addressable memory space in a flash memory.

16. The method of claim 2, wherein the step of defining, in a recording medium, includes defining the addressable memory space in a hard drive.

17. The method of claim 2, wherein the step of defining, in a recording medium, includes defining the addressable memory space in an optical card.

18. The method of claim 2, wherein the step of defining, in a recording medium, includes defining the addressable memory space in an optical disk.

19. The method of claim 2, wherein the step of defining, in a recording medium, includes defining the addressable memory space in a magneto-optical disk.

20. The method of claim 2, wherein the step of defining, in a recording medium, includes defining the addressable memory space in an IC RAM card.