User interface for sedation and analgesia delivery systems and methods

• US 8,567,393 B2
• Filed: 11/01/2002
• Issued: 10/29/2013
• Est. Priority Date: 11/01/2001
• Status: Active Grant

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: Hickle, Randall S., Endsley, Mica R.
• Primary Examiner(s): Dixon, Annette
• Application Number:
  US10/285,689
• Publication Number:
  US 20030135087A1
• Time in Patent Office: 4,015 Days
• Field of Search: 128/200.24, 128/203.12, 128/203.14, 128/204.21, 128/204.23, 128/DIG.13, 600/300, 600/301, 604/65, 604/66, 604/67, 604/23, 604/26, 604/155, 604/503
• US Class Current: 128/203.14
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/63 for local operation

Abstract

The present invention comprises a user interface for systems and methods for sedation and analgesia delivery. The user interface receives input from a user of a sedation and analgesia delivery system and relays information regarding the system, the administration of sedation and analgesia, physiological conditions to the user in a context sensitive manner. The information relayed may be displayed to the user on a touch sensitive screen or multi-layer display device. The display may be segregated geographically or may be color coded on the display device where the geographic location and/or color of the displayed information relates further information to the user.

Claims

1. An improved system for enabling a non-anesthestist practioner to provide safe and effective sedation with the drug propofol to a patient undergoing a medical procedure performed by a procedural physician without general anesthesia, the system comprising:

one or more patient health monitor devices adapted so as to receive a signal reflecting at least one physiological condition of said patient;

a drug delivery controller for administering the drug propofol to said patient;

a user interface sub-system for receiving user input from said non-anesthetist relating to patient weight, and for providing system information regarding the supply of propofol, information regarding the at least one physiological condition, and information that warns said non-anesthetist said user via said user interface if said administration of propofol has placed the patient in one of the following conditions;

general anesthesia, low SpO₂, low respiratory rate, respiratory obstruction, loss of responsiveness, bradycardia, tachycardia, excessively high or low arterial blood pressures, and

an electronic controller having a data set reflecting safe and/or unsafe parameters of the al least one physiological condition operably connected to the one or more patient health monitor devices, the drug delivery controller, and the user interface sub-system;

wherein said electronic controller receives said signal reflecting at least one physiological condition and said user input, and in response manages the application of propofol.

2. The system according to claim 1, wherein the user interface sub-system comprises:

at least one of a touch screen or multi-layer display for displaying and for receiving user input regarding the system, the administration of sedation and analgesia, and the at least one physiological condition; and

a separate set of hard buttons for interacting with the system independently of the touch screen or multi-layer display.

3. The system according to claim 1, wherein the user interface sub-system comprises at least one device for monitoring the system information, the information regarding the administration of propofol, and the information regarding the at least one physiological condition in relation to the parameters and at least one device for allowing the user to control the drug delivery controller and the electronic controller.

4. The system according to claim 3, wherein the at least one physiological condition is selected from the group consisting of ECG, heart rate, blood pressures, Sp02, respiratory rate, ETC02, and patient responsiveness.

5. The system according to claim 3, wherein data from the one or more patient health monitor devices is grouped in geographical areas when displayed on the single screen or multi-layer display, and wherein each geographical area includes data relevant to a patient physiological condition.

6. The system according to claim 5, wherein the data from the one or more patient health monitor devices is grouped in a cardiovascular data geographical area, an oxygenation data geographical area, and a ventilation data geographical area.

7. The system according to claim 6, wherein the oxygenation data geographical area is adjacent to the cardiovascular data geographical area.

8. The system according to claim 6, wherein the oxygenation data geographical area is adjacent to the ventilation data geographical area.

9. The system according to claim 3, wherein the information regarding the administration of propofol comprises information regarding patient drug levels based on pharmacokinetic calculations, and wherein the information regarding the patient drug levels and the information regarding the at least one physiological condition are displayed on the single screen or multi-layer display in positions that facilitate the user in cross-correlating the information regarding the patient drug levels and the information regarding the at least one physiological condition.

10. The system according to claim 9, wherein the single screen or multi-layer display comprises a dedicated portion for displaying information regarding patient state alarms and advisories and system state alarms and advisories.

11. The system according to claim 10, wherein information regarding current alarms and advisories is displayed on the single screen or multi-layer display in positions determined by a priority of the alarms and advisories.

12. The system according to claim 10, wherein the user interface sub-system relays audible indicators to the user that are redundantly indicative of the information regarding the patient state alarms and advisories and system state alarms and advisories displayed to the user.

13. The system according to claim 12, wherein the redundant audible indicators are mutable by the user via the user interface sub-system.

14. The system according to claim 13, wherein a muted redundant audible indicator will remain muted for a pre-set period of time, and wherein the amount of mute time remaining is displayed to the user.

15. The system according to claim 10, wherein information regarding current alarms and advisories is color coded wherein the colors displayed indicate the priority of the alarms and advisories.

16. The system according to claim 1, wherein the system information, the information regarding the administration of propofol, and the information regarding the at least one physiological condition are consistently updated throughout a procedure that is accompanied by the administration of propofol.

17. The system according to claim 1, wherein the system information, the information regarding the administration of propofol, and the information regarding the at least one physiological condition comprise real-time data and historical data.

18. The system according to claim 17, wherein a portion of the real-time data is displayed to the user both as a numerical value and as a graphical waveform.

19. The system according to claim 1, wherein the system information, the information regarding the administration of propofol, and the information regarding the at least one physiological condition are displayed to the user according to a color coded display schema.

20. The system according to claim 1, wherein the system information, the information regarding the administration of propofol and the information regarding the at least one physiological condition comprise information regarding patient state alarms and advisories and system state alarms and advisories.

21. The system according to claim 1, wherein said non-anesthetist is provided with a warning if the user input exceeds the maximum recommended rate for dose, infusion rate and/or effect site concentration,

22. The system according to claim 1, wherein the user interface sub-system displays data from the one or more patient health monitor devices and the information regarding the administration of propofol at a single screen or multi-layer display.

23. An improved method for the safe and effective administration of sedation drugs to a patient undergoing medical and/or surgical procedures by a non-anesthetist without general anesthesia, said method comprising the steps of:

a) connecting to a patient a drug delivery device having a drug delivery controller supplying one or more of said drugs, said drug delivery controller being coupled to an electronic controller which controls the delivery of the drugs to the patient;

b) attaching one or more patient health monitor devices to said patient to reflect a value of at least one physiological condition of said patient for input to said electronic controller;

c) said electronic controller accessing parameters, said parameters including default settings for delivery of drugs to said patient and predetermined values of said monitored physiological condition correlating to safe and effective sedation;

d) said electronic controller comparing said values generated by said patient health monitor devices with said parameters;

e) said electronic controller causing said drug delivery device to modify said desired supply rate of the drugs as necessary in response to said comparing in order to maintain said patient safely within said normal levels of desired sedation during said procedure; and

f) a user interface for permitting input of patient data including patient weight, and for providing information regarding the at least one physiological condition of a patient, and information regarding the delivery of one or more of said drugs, and for warning the non-anesthestist user if the user input and/or the physiological condition of the patient is unsafe.

24. The method of claim 23, wherein the step of attaching one or more patient health monitor devices to a patient comprises attaching patient health monitor devices generating values reflecting patient responsiveness, respiratory effort, and/or oxygenation.

25. The method of claim 24 further comprising the step of presenting the user with a list of ramifications of the user input.

26. The method of claim 23, wherein the step of providing to the user information regarding the at least one physiological condition of a patient and regarding the step of delivery of one or more drugs comprises displaying the information at a single screen or multi-layer display.

27. The method of claim 26, wherein the step of displaying the information at a single screen or multi-layer display comprises the step of grouping the information geographically in a way that facilitates the user to cross-correlate different aspects of the information.

28. The method of claim 26, wherein the step of displaying the information at a single screen or multi-layer display comprises the step of graphically color coding the information in a way that allows the user to quickly assess the relevance of the information to the safe administration of sedation and analgesia.

29. The method of claim 26, wherein the step of displaying the information at a single screen or multi-layer display comprises the step of segregating a portion of the screen or multi-layer display for the dedicated display of system state alarms and advisories and patient state alarms and advisories.

30. The method of claim 29, wherein the step of segregating a portion of the screen or multi-layer display for the dedicated display of system state alarms and advisories and patient state alarms and advisories comprises the step of graphically color coding the segregated portion and display of the system state alarms and advisories and patient state alarms and advisories in a way that allows the user to quickly assess the priority and importance of the system state alarms and advisories and patient state alarms and advisories.

31. The method of claim 23, wherein the step of relaying to the user information regarding the at least one physiological condition of a patient and regarding the step of delivering one or more drugs comprises playing an audible indicator to the user.

32. The method of claim 23 further comprising the step of said user interface prompting the user to confirm changes made to settings of the drug delivery device, or the electronic controller.

33. The method of claim 23 further comprising the step of said user interface continuously notifying the user of changes made to the default settings of the drug delivery device by the electronic controller.

34. The method of claim 23 further comprising the step of reminding the user to ensure that requisite predecessor conditions to the safe administration of sedation are satisfied prior to the step of said electronic controller causing said controllable drug delivery device to modify said desired supply rate of the drugs as necessary.

35. The method of claim 23, wherein the step of receiving input from the user of the drug delivery device, or the electronic controller comprises the steps of receiving input from the user via a touch screen or multi-layer display and receiving input regarding the activation of functionalities of the drug delivery device, or the electronic controller from the user via a separate set of hard keys.

36. The method of claim 23 wherein the step of receiving input from the user of the drug delivery device, or the electronic controller further comprises the step of checking the user input versus known data and/or weight nomograms.