Intelligent pharmaceutical delivery system with automatic shutoff and method of using

• US 10,130,766 B1
• Filed: 10/05/2015
• Issued: 11/20/2018
• Est. Priority Date: 08/08/2012
• Status: Active Grant

• Current Assignee: NeuroWave Systems Inc.
• Original Assignee: NeuroWave Systems Inc.
• Inventors: Bibian, Stephane, Zikov, Tatjana
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Frehe, William
• Application Number:
  US14/874,736
• Time in Patent Office: 1,142 Days
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/372 Analysis of electroencephalograms
• 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 16/0003 Accessories therefor, e.g. sensors, vibrators, negative pressure
• CPC Class Codes: A61M 2202/048 Anaesthetics
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/10 Electroencephalographic signals
• CPC Class Codes: A61M 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A system and method provides closed-loop sedation, anesthesia, or analgesia by monitoring EEG and automatically adjusting the delivery of sedative, anesthetic, and/or analgesic drugs to maintain that desired or predetermined level of cortical at all echelons of care. The system and method further monitor the subject'"'"'s cortical activity to detect occurrence of burst suppression which can be indicative of unsafe depth of anesthesia or sedation. Further, the system and methods provide for alteration or cessation of the administration of anesthesia or sedation based on the occurrence of burst suppression to mitigate harm to the subject.

Claims

1. A system for controlling anesthesia or sedation of a subject, the system comprising:

a physiological signal sensor adapted to acquire a physiological signal from a subject indicative of the subject'"'"'s electroencephalogram (EEG) signal;

an infusion pump adapted to administer anesthetic or sedative to the subject; and

a controller adapted to control the infusion pump and administration of the anesthetic or sedative;

the controller comprising a processor adapted for receiving the physiological signal from the physiological signal sensor and further comprising an algorithm adapted to perform real-time quantitative monitoring of the physiological signal and from this monitoring to detect burst suppression of the subject'"'"'s EEG signal from the physiological signal,

wherein the controller is further adapted to stop anesthetic or sedative administration via the infusion pump based upon a level of burst suppression of the subject'"'"'s EEG signal.

2. The system of claim 1, wherein the algorithm is adapted to calculate a numerical index representative of a level of cortical activity or depth of anesthesia or sedation of the subject using a wavelet analysis of the EEG signal, and the controller is adapted to control the administration of anesthetic or sedative in order to keep the numerical index at a desired or predetermined level corresponding to a desired or predetermined level of consciousness.

3. The system of claim 1, further comprising an output device adapted to provide an alarm or signal to a clinician, the alarm or signal adapted to notify the clinician when the burst suppression of the EEG signal has been detected and the administration of the anesthetic or sedative has been stopped.

4. The system of claim 3, wherein the controller is adapted such that the clinician must reset or instruct the system to be able to resume administration of anesthetic or sedative to the subject.

5. The system of claim 3, wherein the controller is adapted such that the system automatically resumes administration of anesthetic or sedative when the burst suppression of the EEG signal is not detected for a predetermined period of time.

6. The system of claim 3, wherein the controller is programmed to administer the anesthetic or sedative according to label indications of the particular anesthetic or sedative being delivered such that the system cannot exceed recommended dosage unless a clinician programs the controller to do so.

7. The system of claim 6, wherein the controller is adapted such that the system additionally ceases administration of the anesthetic or sedative with the infusion pump when the administered anesthetic or sedative reaches at least one limit programmed according to the label indications of the anesthetic or sedative.

8. A system for controlling anesthesia or sedation of a subject, the system comprising:

a physiological signal sensor adapted to acquire a physiological signal from a subject indicative of the subject'"'"'s electroencephalogram (EEG) signal;

an infusion pump adapted to administer anesthetic or sedative to the subject; and

a controller adapted to control the infusion pump and administration of the anesthetic or sedative;

the controller comprising a processor adapted for receiving the physiological signal from the physiological signal sensor and further comprising an algorithm adapted to perform real-time quantitative monitoring of the physiological signal and from this monitoring to detect burst suppression of the subject'"'"'s EEG signal from the physiological signal,

wherein the controller calculates a numerical index representative of a level of cortical activity or depth of anesthesia or sedation of the subject, and the controller is adapted to control the administration of anesthetic or sedative in order to maintain the numerical index at a desired or predetermined level corresponding to a desired or predetermined level of consciousness, and further to reduce or stop anesthetic or sedative administration below that being used to maintain the desired or predetermined numerical index level via the infusion pump based upon a level of burst suppression of the subject'"'"'s EEG signal.

9. The system of claim 8, wherein the algorithm is adapted to calculate the numerical index representative of a level of cortical activity or depth of anesthesia or sedation of the subject using a wavelet analysis of the EEG signal.

10. The system of claim 8, further comprising an output device adapted to provide an alarm to a clinician, the alarm adapted to notify the clinician that the burst suppression of the EEG signal has been detected.

11. The system of claim 10, wherein the controller is adapted such that the clinician must reset or instruct the system to be able to increase or resume administration of anesthetic or sedative to the subject.

12. The system of claim 10, wherein the controller is adapted such that the system automatically increases or resumes administration of anesthetic or sedative when the burst suppression of the EEG signal is not detected for a predetermined period of time.

13. The system of claim 10, wherein the controller is programmed to administer the anesthetic or sedative according to label indications of the particular anesthetic or sedative being delivered such that the system cannot exceed recommended dosage unless a clinician programs the controller to do so.

14. The system of claim 13, wherein the controller is adapted such that the system additionally ceases administration of the anesthetic or sedative with the infusion pump when the administered anesthetic or sedative reaches at least one limit programmed according to the label indications of the anesthetic or sedative.

15. A system for controlling sedation of a subject, the system comprising:

a physiological signal sensor adapted to acquire a physiological signal from a subject indicative of the subject'"'"'s electroencephalogram (EEG) signal;

an infusion pump adapted to administer anesthetic or sedative to the subject; and

a controller adapted to control the infusion pump and administration of the anesthetic or sedative;

the controller comprising a processor adapted for receiving the physiological signal from the physiological signal sensor and further comprising an algorithm adapted to perform real-time quantitative monitoring of the physiological signal and from this monitoring to detect burst suppression of the subject'"'"'s EEG signal from the physiological signal,

wherein the controller is further adapted to reduce or stop the anesthetic or sedative administration via the infusion pump based upon a level of burst suppression of the subject'"'"'s EEG signal.

16. The system of claim 15, wherein the algorithm is adapted to calculate a numerical index representative of a level of cortical activity or depth of anesthesia or sedation of the subject using a wavelet analysis of the EEG signal.

17. The system of claim 15, further comprising an output device adapted to provide an alarm to a clinician, the alarm adapted to notify the clinician that the burst suppression of the EEG signal has been detected.

18. The system of claim 17, wherein the controller is adapted such that the clinician must reset or instruct the system to be able to increase or resume administration of the anesthetic or sedative to the subject.

19. The system of claim 17, wherein the controller is adapted such that the system automatically increases or resumes administration of the anesthetic or sedative when the burst suppression of the EEG signal is not detected for a predetermined period of time.

20. The system of claim 17, wherein the controller is programmed to administer the anesthetic or sedative according to label indications of the particular anesthetic or sedative being delivered such that the system cannot exceed recommended dosage unless a clinician programs the controller to do so.