FAIL-SAFE MODULE INTEGRAL WITH A SEDATION AND ANALGESIA SYSTEM AND METHOD

• US 20090199851A1
• Filed: 04/17/2009
• Published: 08/13/2009
• Est. Priority Date: 02/25/2002
• Status: Active Grant

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: HICKLE, Randall S., Derouen, Jason
• Granted Patent: US 8,555,876 B2
• Time in Patent Office: Days
• US Class Current: 128/202.22
• CPC Class Codes: A61M 16/01 specially adapted for anaesthetising A61M16/104, A61M16/18 take precedence
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2202/0241 Anaesthetics; Analgesics
• CPC Class Codes: A61M 2205/16 with back-up system in case of failure
• CPC Class Codes: A61M 2205/17 with redundant control systems
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

The invention provides a fail-safe module (FSM) integral with a sedation and analgesia system that meets the high-reliability needs of sedation and/or analgesia delivered by non-anesthetist practitioners. The FSM may operate in “real-time” in order to ensure optimal patient safety. The FSM may deactivate specific patient interfaces, user interfaces, and/or sedation and analgesia delivery in order to ensure patient safety and has redundant safety systems in order to provide the fail-safe module with an accurate assessment of controller functionality.

Claims

1-10. -10. (canceled)

11. A method of safely operating a sedation and analgesia system, wherein the system comprises an electronic controller, a fail safe module, and one or more patient interfaces and wherein the controller commands the one or more patient interfaces during the operation of the system, the method comprising the steps of:

commencing the operation of the sedation and analgesia system;

commencing the operation of the fail safe module, the operation of the fail safe module comprising the step of receiving one or more valid signals indicating a healthy operation of the controller;

electronically managing the delivery of pain- or anxiety-relieving drugs to a patient in accord with at least one physiological condition of the patient;

commencing the operation of the one or more patient interfaces, the operation of the one or more patient interfaces being monitored and supervised by the controller; and

managing the operation of the one or more patient interfaces in accord with one of the receipt and the non-receipt by the fail safe module of the one or more valid signals indicating a healthy operation of the controller.

12. The method of safely operating a sedation and analgesia system according to claim 11, wherein the step of managing the operation of the one or more patient interfaces comprises stopping the operation of the one or more patient interfaces upon the non-receipt by the fail safe module of the one or more valid signals indicating a healthy operation of the controller.

13. The method of safely operating a sedation and analgesia system according to claim 12, wherein a user interface indicates the system is not functioning properly.

14. The method of safely operating a sedation and analgesia system according to claim 13, wherein the user interface indicates the system is not functioning properly with one or more system state alarms.

15. The method of safely operating a sedation and analgesia system according to claim 12, wherein one or more patient interfaces is a system for the delivery of the pain or anxiety relieving drugs to the patient.

16. The method of safely operating a sedation and analgesia system according to claim 12, wherein one or more patient interfaces is a system for the delivery of a gas or gas mixture to the patient.

17. The method of safely operating a sedation and analgesia system according to claim 12, further comprising the step of powering down the sedation and analgesia system upon the non-receipt by the fail safe module of the one or more valid signals indicating a healthy operation of the controller.

18. The method of safely operating a sedation and analgesia system according to claim 12, wherein the step of managing the operation of the one or more patient interfaces further comprises restarting the operation of the one or more patient interfaces upon the receipt by the fail safe module of one or more valid signals indicating a healthy operation of the controller, the receipt occurring after a period of non-receipt of the one or more valid signals.

19. The method of safely operating a sedation and analgesia system according to claim 12, wherein the fail safe comprises memory, and wherein the fail safe module retains in its memory a signifier upon the non-receipt by the fail safe module of the one or more valid signals indicating a healthy operation of the controller.

20. The method of safely operating a sedation and analgesia system according to claim 11, wherein the one or more valid signals comprise a strobe delivered or initiated by the controller for receipt by the fail safe module.

21. The method of safely operating a sedation and analgesia system according to claim 20, wherein the strobe is an electrical strobe in the form of a byte, a plurality of bytes, a pulse, or a TTL or logic signal.

22. The method of safely operating a sedation and analgesia system according to claim 11, further comprising the step of testing the sedation and analgesia system prior to the step of commencing operation of the sedation and analgesia system.

23. The method of safely operating a sedation and analgesia system according to claim 22, wherein the step of testing the sedation and analgesia system comprises the steps of:

initiating a valid test strobe;

transferring the sedation and analgesia system to an operation state mode;

setting inputs to the fail safe module;

outputting a test signal from the controller;

evaluating proper outputs of the fail safe module in operation state mode given current inputs;

initiating an invalid test strobe;

transferring the sedation and analgesia system to a safe state mode;

evaluating proper outputs of the fail safe module in safe state mode given current inputs;

initiating valid strobing; and

transferring the fail safe module to the operation state mode.

24. The method of safely operating a sedation and analgesia system according to claim 23, wherein the steps of initiating a valid test strobe comprises transmitting one stobe or a plurality of strobes from the controller to the fail safe module that fall into a predetermined time window programmed into the fail safe module, wherein such strobe or strobes indicate that the controller is functioning properly.

25. The method of safely operating a sedation and analgesia system according to claim 23, wherein the steps of initiating an invalid test strobe comprises outputting an invalid strobe from the controller to the fail safe module to simulate a failure of the sedation and analgesia system.

26. The method of safely operating a sedation and analgesia system according to claim 25, wherein the invalid strobe comprises rapid strobing or strobing outside of a predetermined time window.

27. The method of safely operating a sedation and analgesia system according to claim 23, wherein the step of setting initial inputs to the fail safe module comprises inputting information related to oxygen delivery, drug delivery, the one or more patient interfaces, or other critical parameters.

28. A method of safely operating a sedation and analgesia system, wherein the system comprises an electronic controller, a fail safe module, and one or more patient interfaces and wherein the controller commands the one or more patient interfaces during the operation of the system, the method comprising the steps of:

commencing the operation of the fail safe module comprising the step of the fail safe module outputting safe state data until a valid strobe or strobing is received from the controller;

upon reception by the fail safe module of the valid strobe or strobing from the controller, commencing the operation of the sedation and analgesia system;

electronically managing the delivery of pain- or anxiety-relieving drugs to a patient in accord with at least one physiological condition of the patient;

commencing the operation of the one or more patient interfaces, the operation of the one or more patient interfaces being monitored and supervised by the controller; and

managing the operation of the one or more patient interfaces in accord with one of the receipt and the non-receipt by the fail safe module of the one or more valid signals indicating a healthy operation of the controller.

29. The method of safely operating a sedation and analgesia system according to claim 28, wherein the operation of the fail safe module further comprises maintaining operation of the sedation and analgesia system contingent upon receipt of a valid strobe or strobing from the controller.

30. The method of safely operating a sedation and analgesia system according to claim 28, wherein the operation of the fail safe module further comprises transferring the sedation and analgesia system into a safe state mode upon non-receipt of valid strobe or strobing from the controller.

31. The method of safely operating a sedation and analgesia system according to claim 30, wherein upon receipt of a valid strobe or strobing from the controller, the fail safe module recommences operation of the sedation and analgesia system