AUTONOMOUS DRUG DELIVERY SYSTEM

• US 20180317841A1
• Filed: 03/01/2018
• Published: 11/08/2018
• Est. Priority Date: 01/28/2014
• Status: Active Grant

• Current Assignee: Masimo Corporation
• Original Assignee: Masimo Corporation
• Inventors: Novak, JR., Jerome J.
• Granted Patent: US 11,259,745 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 5/0015 characterised by features of the telemetry system
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• 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: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3507 with implanted devices, e.g. external control
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• 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 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/168 Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body flow control in general G05D7/00
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/20 : for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/50 : for simulation or modelling of medical disorders

Abstract

An autonomous drug delivery system advantageously utilizes physiological monitor outputs so as to automatically give a bolus of a rescue drug or other necessary medication when certain criteria and confidence levels are met. An emergency button is provided to manually trigger administration of the rescue drug. The rescue drug may be an opioid antagonist in response to an analgesia overdose, a hypotensive drug to avert an excessive drop in blood pressure or an anti-arrhythmia drug to suppress abnormal heartbeats, to name a few.

Claims

1. An automated first responder method, the method comprising:

under control of a hardware processor,

receiving patient data comprising a plurality of physiological parameter values, at least some of the physiological parameter values derived from physiological signals obtained from one or more physiological sensors coupled with a patient;

analyzing the patient data to determine whether the patient data matches at least one of a plurality of diagnostic models represented in computer memory, each diagnostic model representing a possible diagnoses of a different condition and resulting in administration of a different drug;

determining that the patient data matches the at least one diagnostic model;

responsive to said determining, initiating a treatment workflow comprising automatically administering a substance to the patient;

subsequent to said administering, determining that the patient data again matches the diagnostic model; and

responsive to said determining that the patient data again matches the diagnostic model, sending an alert to a clinician over a hospital network, the alert indicating that an additional amount of the substance may be necessary for the patient.

2. The method of claim 1, wherein said receiving the patient data further comprises receiving lab data.

3. The method of claim 2, wherein the lab data comprises data representing a white blood cell count.

4. The method of claim 1, wherein said analyzing the patient data comprises identifying a trend in the physiological parameter values and determining whether the trend corresponds with predetermined trends in the diagnostic model.

5. The method of claim 1, wherein said determining that the patient data matches the diagnostic model comprises identifying a decrease in one of the physiological parameter values and an increase in another one of the physiological parameter values.

6. The method of claim 1, wherein the diagnostic model represents one of the following:

an opioid overdose diagnostic model, a hypovolemia diagnostic model, or a sepsis diagnostic model.

7. The method of claim 6, wherein the opioid overdose diagnostic model corresponds to a decrease in respiratory rate, a decrease in heart rate, and a decrease in blood pressure.

8. The method of claim 7, wherein the substance comprises naloxone.

9. The method of claim 6, wherein the hypovolemia diagnostic model corresponds to a decrease in blood pressure, an increase in heart rate, and stability in hemoglobin level.

10. The method of claim 9, wherein the substance comprises saline.

11. The method of claim 6, wherein the sepsis diagnostic model corresponds to a decrease in blood pressure, an increase in white blood cell count, and an increase in temperature.

12. The method of claim 11, wherein initiating the workflow further comprises one or more of the following:

alerting a clinician, ordering a lab test, ordering a drug, and ordering a radiology test.

13. An automated first responder system, the system comprising:

a patient monitor comprising a hardware processor configured to derive physiological parameter values from physiological signals obtained from one or more physiological sensors coupled with a patient; and

an autonomous delivery device in communication with the patient monitor, the autonomous delivery device comprising at least one substance;

the hardware processor configured to;

analyze the physiological parameter values to determine whether the physiological parameter values correspond with a diagnostic model;

determine that the physiological parameter values correspond with the diagnostic model;

responsive to said determination, initiate a treatment workflow that automatically administers a substance to the patient from the autonomous delivery device;

subsequent to said administration, determine that the physiological parameter values again match the diagnostic model; and

responsive to said determination that the physiological parameter values again match the diagnostic model, send an alert to a clinician over a hospital network, the alert indicating that an additional amount of the substance may be necessary for the patient.

14. The system of claim 13, wherein said analyzing the patient data comprises identifying a trend in the physiological parameter values and determining whether the trend corresponds with predetermined trends in the diagnostic model.

15. The system of claim 13, wherein the diagnostic model represents one of the following:

an opioid overdose diagnostic model, a hypovolemia diagnostic model, or a sepsis diagnostic model.

16. The system of claim 15, wherein the opioid overdose diagnostic model corresponds to a decrease in respiratory rate, a decrease in heart rate, and a decrease in blood pressure.

17. The system of claim 16, wherein the substance comprises naloxone.

18. The system of claim 15, wherein the hypovolemia diagnostic model corresponds to a decrease in blood pressure, an increase in heart rate, and stability in hemoglobin level.

19. The system of claim 18, wherein the substance comprises saline.

20. The system of claim 15, wherein the sepsis diagnostic model corresponds to a decrease in blood pressure, an increase in white blood cell count, and an increase in temperature.

21. The system of claim 20, wherein initiating the workflow further comprises one or more of the following:

alerting a clinician, ordering a lab test, ordering a drug, and ordering a radiology test.

22. An automated first responder system, the system comprising:

a patient monitor comprising a hardware processor configured to derive physiological parameter values from one or more physiological signals obtained from one or more physiological sensors coupled with a patient; and

an autonomous delivery device in communication with the patient monitor, the autonomous delivery device comprising a substance;

the hardware processor programmed to;

analyze the physiological parameter values to determine that the physiological parameter values correspond with a diagnostic model;

output an alarm based on the determination that the physiological parameter values correspond with the diagnostic model;

determine that a response to the alarm has not been received within a predetermined time period; and

cause the substance to be administered to the patient subsequent to the determination that a response to the alarm has not been received within the predetermined time period.

23. The system of claim 22, wherein the hardware processor is further programmed to, subsequent to causing the substance to be administered to the patient:

derive second physiological parameter values;

determine that the second physiological parameter values also correspond with the diagnostic model; and

responsive to said determination that the second physiological parameter values match the diagnostic model, output a second alarm indicating that an additional amount of the substance may be necessary for the patient.

24. The system of claim 22, wherein the diagnostic model represents one of the following:

an opioid overdose diagnostic model, a hypovolemia diagnostic model, or a sepsis diagnostic model.