Systems and methods for providing trend analysis in a sedation and analgesia system

• US 8,028,694 B2
• Filed: 10/03/2003
• Issued: 10/04/2011
• Est. Priority Date: 10/03/2002
• Status: Expired due to Fees

• Current Assignee: Scott Laboratories, Inc.
• Original Assignee: Scott Laboratories, Inc.
• Inventors: Hickle, Randall S.
• Primary Examiner(s): Douglas; Steven O
• Application Number:
  US10/677,482
• Publication Number:
  US 20050039742A1
• Time in Patent Office: 2,923 Days
• Field of Search: 128/200.24, 128/204.23, 128/204.21, 128/DIG.12, 128/DIG.13, 128/203.12, 128/203.14, 600/538, 600/500, 600/300, 600/301, 600/513, 600/523, 604/65, 604/49, 604 30- 34, 604/50, 604/66.67, 604/118, 604/151, 604/246, 606/39, 606/42
• US Class Current: 128/203.14
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/0245 by using sensing means generating electric signals, i.e. ECG signals
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/01 specially adapted for anaesthetising A61M16/104, A61M16/18 take precedence
• CPC Class Codes: A61M 16/026 specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
• CPC Class Codes: A61M 16/161 with means for measuring the humidity
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/1035 the anaesthetic agent concentration
• CPC Class Codes: A61M 2205/17 with redundant control systems
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: G16H 20/10 : relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/67 : for remote operation

Abstract

The present invention includes a sedation and analgesia system capable of gathering data from a single monitor associated with a single patient parameter in a manner that diminishes the probability of false positive alarms responses due to data artifact. The invention also includes a monitoring system that is able to detect imminent adverse patient conditions, where such conditions may be detected before an adverse patient condition actually occurs. The invention further includes methods for incorporating trend analysis into a sedation and analgesia system.

Claims

1. A sedation and analgesia system, comprising:

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

a user interface;

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

an electronic controller interconnected with the patient health monitor, the user interface, and the drug delivery controller, said electronic controller having a data set reflecting parameters of at least one monitored patient physiological condition, wherein said electronic controller receives said patient parameter and, throughout operation of the sedation and analgesia system, continually analyzes trends of said patient parameter in accord with the data set to determine whether adverse patient conditions are imminent and to initiate suitable action.

2. The sedation and analgesia system of claim 1, further comprising one or more effectors for ensuring patient safety and clinician awareness, wherein said electronic controller is interconnected with the effector and controls the effector in accordance said trends of said patient parameter.

3. The sedation and analgesia system of claim 1, wherein said electronic controller provides preemptive warnings in response to adverse trends of said patient parameter within a range of said data set.

4. The sedation and analgesia system of claim 1, wherein said electronic controller evaluates said patient parameter measurements against said trends.

5. The sedation and analgesia system of claim 1, wherein said patient parameter is one derived from capnometry, pulse oximetry, and blood pressure.

6. The sedation and analgesia system of claim 1, wherein said patient parameter is heart rate.

7. The sedation and analgesia system of claim 1, wherein said at least one patient health monitor is one of an electrocardiograph and a pulse oximeter.

15. The system of claim 2, wherein said effector is one or more of a drug decrease, drug increase, positive airway pressure change, pre-alarm, oxygen delivery, trigger for additional data sampling from monitors, change in drugs, and patient responsiveness query.

16. The system of claim 1, wherein the suitable action comprises at least one of initiating a pre-alarm, pausing drug delivery, and initiating a full alarm.

8. A method for incorporating trend analysis into a sedation and analgesia system, comprising the steps of:

providing a patient monitor for a patient to monitor a single patient parameter;

monitoring the patient with the monitor, wherein data collected from the monitor may be transmitted to a controller of the sedation and analgesia system;

creating a trend based on the data received from the monitor;

at least one of inputting the trend into an algorithm of the sedation and analgesia system and, throughout operation of the sedation and analgesia system, continually analyzing the trend to determine whether adverse patient conditions are imminent; and

initiating suitable action based on the trend analysis.

9. The method of claim 8, wherein said step of analyzing includes at least one of calculating the slope of the trend, calculating multiple slopes for trend variation, calculating coefficients of polynomials of the trend, and curve-fitting the slope using a least mean square error technique.

10. The method of claim 8, further comprising the step of calculating a probability value for whether data presented to the controller is actually indicative of a slope change.

11. The method of claim 8, wherein the trend is analyzed in combination with trends from related patient parameters.

12. The method of claim 9, wherein the trend is incorporated as a feature of orthogonal redundancy.

13. The method of claim 8, wherein the trend is integrated into at least one neural network.

14. The method of claim 8, wherein the suitable action comprises at least one of continuing to monitor, initiating a pre-alarm, pausing drug delivery, and initiating a full alarm.