Fail-safe module integral with a sedation and analgesia system and method

• US 20030217747A1
• Filed: 02/25/2003
• Published: 11/27/2003
• Est. Priority Date: 02/25/2002
• Status: Active Grant

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: Derouen, Jason, Hickle, Randall S.
• Granted Patent: US 7,527,052 B2
• Time in Patent Office: Days
• US Class Current: 128/203.12
• 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. A sedation and analgesia system comprising:

a patient health monitor device adapted so as to be coupled to a patient and generate a signal reflecting at least one physiological condition of the patient;

a drug delivery controller supplying one or more drugs to the patient;

a memory device storing a safety data set reflecting safe and undesirable parameters of at least one monitored patient physiological condition;

an electronic controller interconnected between the patient health monitor, the drug delivery controller and the memory device storing the safety data set;

wherein said electronic controller receives said signal and in response manages the application of the drugs in accord with the safety data set; and

a fail safe module receiving a signal from the electronic controller, the signal from the electronic controller indicating a healthy operation of the electronic controller, wherein the fail safe module is interconnected with the electronic controller such that in the absence of a signal indicating a healthy operation of the controller, the fail safe module stops the electronic controller from managing the application of the drugs.

2. The sedation and analgesia system according to claim 1, further comprising an interface for indicating that during the absence of a signal indicating a healthy operation of the controller, the system is not functioning properly.

3. The sedation and analgesia system according to claim 2, wherein the interface indicates the system is not functioning properly with one or more system state alarms.

4. The sedation and analgesia system according to claim 1, further comprising a gas delivery system for the delivery of at least one gas or gas mixture to the patient, wherein the electronic controller is further interconnected with the gas delivery system and manages the delivery of the at least one gas or gas mixture in accord with the safety data set.

5. The sedation and analgesia system according to claim 4, wherein upon the absence of a signal indicating a healthy operation of the controller, the fail safe module stops the electronic controller from managing the delivery of at least one gas or gas mixture.

6. The sedation and analgesia system according to claim 4, wherein the fail safe module comprises a memory module, and wherein upon the absence of a signal indicating a healthy operation of the controller, the fail safe module stores information indicating the absence of said signal indicating a healthy operation of the controller in the memory module.

7. The sedation and analgesia system according to claim 1, wherein upon the receipt of the signal indicating a healthy operation of the controller after a period of absence in receiving the signal, the fail safe module restarts the electronic controller'"'"'s management of the application of the drugs.

8. The sedation and analgesia system according to claim 1, wherein the signal indicating a healthy operation of the controller is a strobe.

9. The sedation and analgesia system according to claim 1, wherein the signal indicating a healthy operation of the controller is a health check signal.

10. The sedation and analgesia system according to claim 1, comprising a health check system interconnected with the fail safe module, wherein the health check system receives one or more signals from one or more subsystems of the sedation and analgesia system indicating a healthy operation of the one or more subsystems.

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.