Secure patient data recorder for recording monitored vital sign data

• US 9,165,111 B1
• Filed: 10/30/2007
• Issued: 10/20/2015
• 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:
  US11/927,993
• Time in Patent Office: 2,912 Days
• Field of Search: None
• US Class Current: 1/1
• 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 encouraging the recordation of patient vital sign data, comprising the steps of:

(a) providing a monitor and recorder system, the monitor and recorder system including a monitor unit, at least one sensing device connected thereto, and a memory module;

(b) applying the at least one sensing device to collect vital sign data from a patient;

(c) during operation of the monitor and recorder system, automatically determining, via an interlock system, whether the memory module is prepared to accept vital sign information received by the monitor unit via the at least one sensing device;

(d) if, in the determining step, it is determined that the memory module is prepared to accept vital sign information received by the monitor unit via the at least one sensing device;

(i) receiving vital sign information from the patient via the monitor unit,

(ii) displaying, on a display unit, data representative of the vital sign information as it is gathered from the patient, and

(iii) recording data representative of at least some of the vital sign information on the memory module; and

(e) if, in the determining step, it is determined that the memory module is not prepared to accept vital sign information received by the monitor unit via the at least one sensing device;

(i) controlling operation of the monitor and recorder system at least by providing a user-perceptible indication to warn an operator of the monitor and recorder system that the memory module is not prepared to accept vital sign information received by the monitor unit via the at least one sensing device, and

(ii) concurrently therewith, controlling operation of the monitor and recorder system by automatically preventing the monitor unit from displaying, on the monitor unit, a graphical representation of the vital sign information as it is gathered from the patient.

2. The method of claim 1, wherein the monitor and recorder system is a bedside monitor and recorder device, and wherein the method further comprises the step of positioning the monitor and recorder system adjacent the patient.

3. The method of claim 1, wherein the data displayed in the displaying step is displayed in a graphical format.

4. The method of claim 1, wherein the data displayed in the displaying step is displayed in a numerical format.

5. The method of claim 1, wherein the data displayed in the displaying step is displayed in a textual format.

6. The method of claim 1, wherein the step of providing a monitor and recorder system including a monitor unit includes incorporating the display unit into the monitor unit.

7. The method of claim 1, wherein the step of providing a monitor and recorder system includes providing a display unit that includes a plurality of distinct display units.

8. The method of claim 1, wherein the step of providing a monitor and recorder system includes providing a display unit that is a single display unit that includes a plurality of display areas therein.

9. The method of claim 1, further comprising the step, if in the determining step it is determined that the memory module is prepared to accept vital sign information received by the monitor unit via the at least one sensing device, of externally communicating data, representative of the vital sign information gathered from the patient, to a remote device.

10. The method of claim 9, wherein the step of externally communicating data to a remote device includes externally communicating data to a remote device that is not physically present in a room in which the monitor unit is located.

11. The method of claim 9, wherein the step of displaying data on a display unit includes displaying data on the remote device.

12. The method of claim 11, wherein the step of displaying data on a display unit includes displaying data on the remote device and also includes displaying data on a display unit disposed adjacent to the monitor unit.

13. The method of claim 9, further comprising the step of connecting the remote device to the monitor unit via a communications network.

14. The method of claim 9, wherein the remote device is a personal computer, the method further comprising connecting the personal computer directly to the monitor unit.

15. The method of claim 9, wherein the step of providing the monitor and recorder system includes incorporating the memory module in the remote device.

16. The method of claim 15, further comprising the step of communicatively connecting the remote device to the monitor unit via wired connection.

17. The method of claim 15, further comprising the step of communicatively connecting the remote device to the monitor unit via wireless connection.

18. The method of claim 1, wherein the providing step includes enclosing the memory module and the monitor unit within the same integral enclosure.

19. The method of claim 1, wherein the providing step includes enclosing the memory module in a structure that is separate from the monitor unit.

20. The method of claim 19, wherein the providing step includes enclosing the memory module in a structure that is separate from the monitor unit but securely fastened to the exterior thereof.

21. The method of claim 19, wherein the providing step includes electrically connecting the memory module and the monitor unit.

22. The method of claim 21, further comprising the steps, if in the determining step it is determined that the memory module is prepared to accept vital sign information received by the monitor unit via the at least one sensing device, of:

externally communicating data, representative of the vital sign information gathered from the patient, to a remote device; and

displaying data on the remote device.

23. A method of encouraging the recordation of patient vital sign data, comprising the steps of:

(a) providing a monitor unit having at least one sensing device connected thereto;

(b) applying the at least one sensing device to collect vital sign data from a patient;

(c) during operation of the monitor unit, automatically determining, via an interlock system, whether an operable patient data recorder is communicatively connected to the monitor unit;

(d) if, in the determining step, it is determined that an operable patient data recorder is communicatively connected to the monitor unit;

(i) receiving vital sign information from the patient at the monitor unit via the at least one sensing device,

(ii) displaying, on a display unit, data representative of the vital sign information as it is received from the patient, and

(iii) transmitting data representative of at least some of the vital sign information to the patient data recorder for recordation therein; and

(e) if, in the determining step, it is determined that an operable patient data recorder is not communicatively connected to the monitor unit;

(i) controlling operation of the monitor and recorder system at least by providing a user-perceptible indication to warn an operator of the monitor unit that an operable patient data recorder is not communicatively connected to the monitor unit, and

(ii) concurrently therewith, controlling operation of the monitor and recorder system by automatically preventing the monitor unit from displaying, on the display unit, data representative of the vital sign information as it is received from the patient.

24. The method of claim 23, wherein the monitor is a bedside monitor, and wherein the method further comprises the step of positioning the bedside monitor adjacent the patient.

25. The method of claim 23, wherein the data displayed in the displaying step is displayed in a graphical format.

26. The method of claim 23, wherein the data displayed in the displaying step is displayed in a numerical format.

27. The method of claim 23, wherein the data displayed in the displaying step is displayed in a textual format.

28. The method of claim 23, wherein the step of providing a monitor and recorder system including a monitor unit includes incorporating the display unit into the monitor unit.

29. The method of claim 23, wherein the step of providing a monitor and recorder system includes providing a display unit that includes a plurality of distinct display units.

30. The method of claim 23, wherein the step of providing a monitor and recorder system includes providing a display unit that is a single display unit that includes a plurality of display areas therein.

31. The method of claim 23, further comprising the step, if in the determining step it is determined that an operable patient data recorder is communicatively connected to the monitor unit, of externally communicating data, representative of the vital sign information received from the patient, to a remote device.

32. The method of claim 31, wherein the step of externally communicating data to a remote device includes externally communicating data to a remote device that is not physically present in a room in which the monitor unit is located.

33. The method of claim 31, wherein the step of displaying data on a display unit includes displaying data on the remote device.

34. The method of claim 31, wherein the step of displaying data on a display unit includes displaying data on the remote device and also includes displaying data on a display unit disposed adjacent to the monitor unit.

35. The method of claim 31, further comprising the step of connecting the remote device to the monitor unit via a communications network.

36. The method of claim 31, wherein the remote device is a personal computer, the method further comprising connecting the personal computer directly to the monitor unit.

37. The method of claim 31, wherein the step of providing the monitor and recorder system includes incorporating the patient data recorder is incorporated in the remote device.

38. The method of claim 37, further comprising the step of communicatively connecting the remote device to the monitor unit via wired connection.

39. The method of claim 37, further comprising the step of communicatively connecting the remote device to the monitor unit via wireless connection.

40. The method of claim 23, further comprising a step of providing the patient data recorder, and wherein the patient data recorder and the monitor unit are provided within the same integral enclosure.

41. The method of claim 23, further comprising a step of providing the patient data recorder in an enclosed structure that is separate from the monitor unit.

42. The method of claim 41, wherein the step of providing the patient data recorder includes enclosing the patient data recorder in a structure that is separate from the monitor unit but securely fastened to the exterior thereof.

43. The method of claim 41, wherein the step of providing the patient data recorder includes electrically connecting the patient data recorder and the monitor unit.

44. The method of claim 43, further comprising the steps, if in the determining step it is determined that that an operable patient data recorder is communicatively connected to the monitor unit, of:

externally communicating data, representative of the vital sign information gathered from the patient, to a remote device; and

displaying data on the remote device.

45. A method of encouraging the recordation of patient vital sign data, comprising the steps of:

(a) providing a monitor and recorder system, the monitor and recorder system including a monitor unit and a memory module;

(b) connecting at least one sensing device to the monitor unit;

(c) facilitating the arrangement of the at least one sensing device in operative relationship with a patient;

(d) during operation of the monitor and recorder system, automatically determining, via an interlock system, whether the memory module is prepared to accept vital sign information received by the monitor unit via the at least one sensing device;

(e) if, in the determining step, it is determined that the memory module is prepared to accept vital sign information received by the monitor unit via the at least one sensing device, receiving vital sign information from the patient via the monitor unit and recording data representative of at least some of the vital sign information on the memory module; and

(f) if, in the determining step, it is determined that the memory module is not prepared to accept vital sign information received by the monitor unit via the at least one sensing device, controlling operation of the monitor and recorder system at least by providing a user-perceptible indication to warn an operator of the monitor and recorder system that the memory module is not prepared to accept vital sign information received by the monitor unit via the at least one sensing device, and concurrently therewith, controlling operation of the monitor and recorder system by automatically preventing the monitor unit from receiving vital sign information via the at least one sensing device.

46. A method of encouraging the recordation of patient vital sign data, comprising the steps of:

(a) providing a monitor unit;

(b) connecting at least one sensing device to the monitor unit;

(c) facilitating the arrangement of the at least one sensing device in operative relationship with a patient;

(d) during operation of the monitor unit, automatically determining, via an interlock system, whether an operable patient data recorder is communicatively connected to the monitor unit;

(e) if, in the determining step, it is determined that an operable patient data recorder is communicatively connected to the monitor unit, receiving vital sign data from the patient at the monitor unit via the at least one sensing device and transmitting data representative of at least some of the vital sign data to the patient data recorder for recordation therein; and

(f) if, in the determining step, it is determined that an operable patient data recorder is not communicatively connected to the monitor unit, controlling operation of the monitor unit at least by providing a user-perceptible indication to warn an operator of the monitor unit that an operable patient data recorder is not communicatively connected to the monitor unit, and, concurrently therewith, controlling operation of the monitor unit by automatically preventing the monitor unit from receiving vital sign data via the at least one sensing device.

47. A method of encouraging the recordation of patient vital sign data, comprising the steps of:

(a) providing a monitor and recorder system, the monitor and recorder system including a display unit, at least one sensing device, and a memory module;

(b) facilitating the arrangement of the at least one sensing device in operative relationship with a patient;

(c) during operation of the monitor and recorder system, automatically determining, via an interlock system, whether the memory module is prepared to accept vital sign information received by the display unit via the at least one sensing device;

(d) if, in the determining step, it is determined that the memory module is prepared to accept vital sign information received by the display unit via the at least one sensing device, receiving vital sign information from the patient via the display unit and recording data representative of at least some of the vital sign information on the memory module; and

(e) if, in the determining step, it is determined that the memory module is not prepared to accept vital sign information received by the display unit via the at least one sensing device, controlling operation of the monitor and recorder system at least by providing a user-perceptible indication to warn an operator of the monitor and recorder system that the memory module is not prepared to accept vital sign information received by the display unit via the at least one sensing device, and, concurrently therewith, controlling operation of the monitor and recorder system by automatically preventing the display unit from receiving vital sign information via the at least one sensing device.

48. A method of encouraging the recordation of patient vital sign data, comprising the steps of:

(a) providing a display unit and at least one sensing device;

(b) facilitating the arrangement of the at least one sensing device in operative relationship with a patient;

(c) during operation of the display unit, automatically determining, via an interlock system, whether an operable patient data recorder is communicatively connected to the display unit;

(d) if, in the determining step, it is determined that an operable patient data recorder is communicatively connected to the display unit, receiving vital sign data from the patient at the display unit via the at least one sensing device and transmitting data representative of at least some of the vital sign data to the patient data recorder for recordation therein; and

(e) if, in the determining step, it is determined that an operable patient data recorder is not communicatively connected to the display unit, controlling operation of the display unit at least by providing a user-perceptible indication to warn an operator of the display unit that an operable patient data recorder is not communicatively connected to the display unit, and, concurrently therewith, controlling operation of the display unit by automatically preventing the display unit from receiving vital sign data via the at least one sensing device.

49. A method of encouraging the recordation of patient vital sign data, comprising the steps of:

(a) providing a recorder system, the recorder system including a display unit, at least one sensing device, and a memory module;

(b) facilitating the arrangement of the at least one sensing device in operative relationship with a patient;

(c) during operation of the recorder system, automatically determining whether the memory module is prepared to accept vital sign information gathered by the display unit;

(d) if the memory module is prepared to accept vital sign information;

(i) receiving vital sign information from the patient via the display unit,

(ii) displaying, on the display unit, a graphical representation of the vital sign information as it is gathered from the patient, and

(iii) recording data representative of at least some of the vital sign information on the memory module; and

(e) if the memory module is not prepared to accept vital sign information;

(i) controlling operation of the recorder system at least by providing a user-perceptible indication to warn an operator of the recorder system that the memory module is not prepared to accept vital sign information, and

(ii) concurrently therewith, controlling operation of the recorder system by automatically preventing the display unit from displaying, on the display unit, a graphical representation of the vital sign information as it is gathered from the patient.