System and method for transparent early detection, warning, and intervention during a medical procedure

• US 7,034,692 B2
• Filed: 05/13/2003
• Issued: 04/25/2006
• Est. Priority Date: 05/13/2002
• Status: Active Grant

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: Hickle, Randall S.
• Primary Examiner(s): Hofsass, Jeffery
• Assistant Examiner(s): Bugg, George A.
• Application Number:
  US10/436,497
• Publication Number:
  US 20030214409A1
• Time in Patent Office: 1,078 Days
• Field of Search: 340/573.1, 600/301, 600/323, 600/364, 600/529, 128/200.24
• US Class Current: 340/573.1
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• 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 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

The present invention relates, in general, to prevention of false, annoying, or oversensitive alarms, providing early detection by a sensitive test, generating silent, semi-overt, or overt alarm conditions and/or initiating early passive or active interventions to untoward events. The invention buys time by providing an early intervention in the event that a highly sensitive early detection is later confirmed by a specific test. A particular embodiment of the invention is directed to the early detection of hypoventilation, including apnea and airway obstruction, and the pausing or interrupting of an action such as drug delivery during medical procedures.

Claims

1. A drug delivery system for use during the performance of a medical procedure that monitors the ventilatory conditions of a patient and provides automated responses to certain of those conditions comprising:

a respiratory gas exchange monitor including means to output monitoring data;

a high-sensitivity alarm algorithm to process said monitoring data, wherein said high sensitivity alarm algorithm is used for detection of a potential onset of a declining ventilatory condition, as indicated by measurement of a predetermined parameter;

a high-specificity alarm algorithm to process said monitoring data; and

an automated device for controlling a drug delivery mechanism in response to said data processed by said high-sensitivity and high-specificity alarm algorithms, wherein said system reduces false positive and false negative alarms in a manner that is transparent to a user.

2. The system according to claim 1, wherein said high sensitivity alarm algorithm utilizes a moving average of said monitoring data.

3. The system according to claim 1, wherein said high specificity alarm algorithm utilizes a cumulative sum of said monitoring data.

4. The system according to claim 1, wherein said detection is used to activate a silent alarm and a hypervigilant state.

5. The system according to claim 1, wherein said detection is used to activate at least one of a semi-overt alarm and a silent alarm.

6. The system according to claim 1, wherein said detection is used to initiate an action.

7. The system according to claim 6, wherein said action may be passive intervention.

8. The system according to claim 7, wherein a discontinuation of said highly sensitive alarm activates a cessation of said passive action and a stand down from said hypervigilant condition.

9. The system according to claim 6, wherein said action may be active intervention.

10. The system according to claim 9, wherein a discontinuation of said highly sensitive alarm causes activates a cessation of said active action and a stand down from said hypervigilant condition.

11. The system according to claim 1, wherein said high specificity alarm algorithm provides a confirmation of an alarm condition resulting from said highly sensitive alarm algorithm.

12. The system according to claim 11, wherein said confirmation is used to generate an overt alarm condition.

13. The system according to claim 11, wherein said confirmation is used to conduct one of an initiation and continuation of an automated corrective action.

14. The system according to claim 1, wherein said high specificity alarm algorithm provides a contradiction, said contradiction being used to maintain said hypervigilant state so long as said alarm condition resulting from said highly sensitive alarm algorithm continues.

15. The system according to claim 1, wherein said drug delivery system is a sedation and analgesia system.

16. The system according to claim 15, wherein said respiratory gas exchange monitor measures CO₂ levels of said patient.

17. The system according to claim 16, wherein said drug delivery mechanism administers at least one respiratory depressant.

18. The system according to claim 17, wherein said respiratory depressant is propofol.

19. A system for safely delivering a respiratory depressant such as a sedative and/or analgesic to a patient during the performance of a medical procedure by monitoring selected medical conditions of a patient and by controlling drug delivery in response thereto, said system comprising:

a monitor that measures selected medical parameters including means to output monitoring data regarding said medical parameters;

a high-sensitivity alarm algorithm to process said monitoring data, wherein said high sensitivity alarm algorithm is used for-detection of a potential onset of a declining ventilatory condition, as indicated by measurement of a predetermined parameter;

a high-specificity alarm algorithm to process said monitoring data; and

automated means for responding to said high-sensitivity and high-specificity alarm algorithms, wherein said high sensitivity alarm algorithm is used for detection of a potential onset of an undesirable trend in said selected medical parameter and wherein said detection is used to initiate a passive intervention and wherein said system reduces false positive and false negative alarms in a manner that is transparent to a user.

20. The system according to claim 19, wherein said high sensitivity alarm algorithm utilizes a moving average of said monitoring data.

21. The system according to claim 19, wherein said high specificity alarm algorithm utilizes a cumulative sum of said monitoring data.

22. The system according to claim 19, wherein said detection is used to activate a silent alarm and a hypervigilant state.

23. The system according to claim 19, wherein said detection is used to activate at least one of a semi-overt alarm and-a silent alarm.

24. The system according to claim 19, wherein said detection is used to initiate an action.

25. The system according to claim 24, wherein said action may be passive intervention.

26. The system according to claim 25, wherein a discontinuation of said highly sensitive alarm activates a cessation of said passive action and a stand down from said hypervigilant condition.

27. The system according to claim 24, wherein said action may be active intervention.

28. The system according to claim 27, wherein a discontinuation of said highly sensitive alarm causes activates a cessation of said active action and a stand down from said hypervigilant condition.

29. The system according to claim 19, wherein said high specificity alarm algorithm provides a confirmation of an alarm condition resulting from said highly sensitive alarm algorithm.

30. The system according to claim 29, wherein said confirmation is used to generate an overt alarm condition.

31. The system according to claim 29, wherein said confirmation is used to conduct one of an initiation and continuation of an automated corrective action.

32. The system according to claim 19, wherein said high specificity alarm algorithm provides a contradiction, said contradiction being used to maintain said hypervigilant state so long as said alarm condition resulting from said highly sensitive alarm algorithm continues.

33. A drug delivery system for use during the performance of a medical procedure that monitors ventilatory conditions of a patient and provides automated responses to certain of those conditions comprising:

means for monitoring said ventilatory conditions, wherein said monitoring means includes means to output monitoring data;

means for processing said monitoring data using a high-sensitivity alarm algorithm, wherein said high sensitivity alarm algorithm is used for detection of a potential onset of a declining ventilatory condition, as indicated by measurement of a predetermined parameter;

means for processing said monitoring data using a high-specificity alarm algorithm; and

automated means for controlling a drug delivery mechanism in response to said processed data, wherein said system reduces false positive and false negative alarms in a manner that is transparent to a user.

34. The system according to claim 33, wherein said detection is used to initiate an action.

35. A method of drug delivery for use during the performance of a medical procedure that monitors ventilatory conditions of a patient and provides automated responses to certain of those conditions comprising:

monitoring said ventilatory conditions, wherein said monitoring means includes means to output monitoring data;

processing said monitoring data using a high-sensitivity alarm algorithm, wherein said high sensitivity alarm algorithm is used for detection of a potential onset of a declining ventilatory condition, as indicated by measurement of a predetermined parameter;

processing said monitoring data using a high-specificity alarm algorithm; and

controlling a drug delivery mechanism in response to said processed data, wherein said system reduces false positive and false negative alarms in a manner that is transparent to a user.

36. The method according to claim 35, wherein said detection is used to initiate an action.

37. A drug delivery system for safely delivering a respiratory depressant such as a sedative and/or analgesic to a patient during the performance of a medical procedure by monitoring the ventilatory condition of the patient and by controlling drug delivery in response thereto, said system comprising:

a respiratory gas exchange monitor for receiving data reflecting the ventilatory condition of said patient during said surgery;

a first alarm algorithm to process said monitoring data;

a second alarm algorithm to continue to receive data and to further process said data in the event said first alarm algorithm indicates a suspect ventilatory condition; and

an automated device for controlling a drug delivery mechanism to said patient in response to said data processed by said first and/or second alarm algorithms.

38. The system according to claim 37, wherein said system reduces false positive and false negative alarms in a manner that is transparent to a user.

39. The system according to claim 38, wherein said first alarm algorithm utilizes a moving average of said monitoring data.

40. The system according to claim 38, wherein said second alarm algorithm utilizes a cumulative sum of said monitoring data.

41. The system according to claim 38, wherein said first alarm algorithm is used for detection of a potential onset of a declining ventilatory condition, as indicated by measurement of a predetermined parameter.