Drug dispensing controller and monitoring system for a ventilator

• US 9,675,769 B2
• Filed: 07/17/2014
• Issued: 06/13/2017
• Est. Priority Date: 06/15/2007
• Status: Active Grant

• Current Assignee: iDTx Systems, Inc
• Original Assignee: iDTx Systems, Inc
• Inventors: Spandorfer, Michael
• Primary Examiner(s): Dixon, Annette
• Application Number:
  US14/334,177
• Publication Number:
  US 20140326238A1
• Time in Patent Office: 1,062 Days
• Field of Search: 12820014, 12820018, 12820022, 12820023, 12820026, 12820312, 12820315, 12820323, 12820324, 12820328, 12820329, 12820411, 12820418, 12820524, 12820714, 12820715
• CPC Class Codes: A61B 5/0075 by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy A61B5/0071 takes precedence
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 15/0003 with means for dispensing more than one drug
• CPC Class Codes: A61M 15/0005 with means for agitating the medicament
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0083 Timers
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 16/0003 Accessories therefor, e.g. sensors, vibrators, negative pressure
• CPC Class Codes: A61M 16/08 Bellows; Connecting tubes having means for taking samples G01N1/22; Water traps; Patient circuits
• CPC Class Codes: A61M 16/14 by mixing different fluids, one of them being in a liquid phase
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/003 with a flowmeter
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/8206 battery-operated

Abstract

An automated drug delivery and monitoring system for use on mechanically ventilated patients in the intensive care unit is presented. Medication in the form of respirable particles is transported through ventilator circuitry by a delivery unit. Multiple medications may be delivered into the gas flow of the ventilator, with each medication delivered in a defined dose for a frequency and interval as specified by an operator. The particles mixed into the gas flow of the ventilator are inhaled and ingested by the patent'"'"'s lungs.

Claims

1. An automated medical system for controlling medication dispensed to a ventilator circuit that extends between a mechanical ventilator and a patient, comprising:

a gas conduit having axially opposing first and second ends, each end being in-line with and adapted to attach to spaced apart segments of tubing of the ventilator circuit to form part of the ventilation circuit;

at least one pressurized metered dose inhaler (pMDI) canister held orthogonal to the gas conduit with a dispensing end of the pMDI canister held proximate the gas conduit in fluid communication with the ventilator circuit via the gas conduit;

an actuator in communication with the at least one pMDI canister to press against the at least one pMDI canister to release medication from the dispensing end to the gas conduit then into the tubing of the ventilator circuit;

a housing holding the gas conduit, the at least one pMDI canister and the actuator;

a control unit residing away from the housing and attached to the housing by a cable, the control unit comprising an operator interface configured to allow an operator to adjust dosage and schedule medication dispensing for each of the at least one pMDI canister and to actuate the actuator to dispense medication from each of the at least one pMDI canister to the ventilator circuit at a defined dosage, delivery time and/or frequency, wherein the control unit monitors air pathway flow in the ventilator circuit and is configured to time actuation of the actuator so that medication from the at least one pMDI canister is released from the at least one pMDI canister only during an inspiratory/inhale cycle with gas flow toward the patient; and

a display held by the control unit for displaying parameters including number of doses remaining for each of the at least one pMDI canister.

2. The system of claim 1, wherein the control unit operator interface is a touch screen input provided by the display.

3. The system of claim 2, wherein the operator interface comprises a manual actuation input on the display to thereby allow a user to electronically initiate actuation of the actuator.

4. The system of claim 1, wherein actuator resides above the gas conduit in the housing, and wherein a delivery path from the dispensing end of the at least one pMDI canister is directly into an axially extending flow path that is in-line with of the gas conduit.

5. The system of claim 1, wherein the actuator is configured to push down against the at least one pMDI canister to release the medication from the at least one pMDI canister.

6. The system of claim 1, wherein the at least one pMDI canister is a plurality of spaced apart pMDI canisters that are held in the housing, wherein the control unit is configured to direct the at least one actuator to serially actuate the plurality of pMDI canisters.

7. The system of claim 1, wherein the control unit comprises a dosage counter and a clock, and wherein the dosage counter decrements a count in response to actuation of the actuator or a respective pMDI canister to provide the number of doses remaining.

8. The system of claim 1, wherein the housing is a delivery unit that is in close proximity to the patient and ventilator tubing.

9. The system of claim 1, wherein the control unit is a hand-held control unit.

10. The system of claim 1, wherein the system is configured to analyze patient effluent gases, wherein the control unit automatically increases or decreases a dosage frequency or dosage amount or both dosage frequency and amount for the at least one pMDI canister based on that analyzed patient effluent gases.

11. The system of claim 1, further comprising a gas flow resistance sensor in communication with the control unit to determine a pressure and volume of gas flow through said gas conduit so that the control unit can determine patient airway resistance and/or a cycle time on reversal of gas flow to assess whether the patient has an impaired ability to intake medicament from the at least one pMDI canister through the lungs, wherein the control unit automatically increases a dosage frequency or dosage amount or both dosage frequency and amount for the at least one pMDI canister when it determines that the patient has the impaired ability.

12. The system of claim 1, further comprising a sensor that continuously detects ventilator circuit conditions and/or patient airway resistance, wherein said control unit modifies an interval of actuation of the at least one actuator for the at least one pMDI canister in response to a defined change in gas pressure in the ventilator circuit.

13. The system of claim 1, wherein the control unit comprises an Ethernet interface to provide remote access to one or more other computers for remote monitoring and/or upload/download.

14. The system of claim 1, wherein the system and/or control unit comprises a log of usage, medications dispensed to the patient by the system and a drug configuration library.

15. The system of claim 1, wherein the control unit operator interface comprises a menu with control and configuration selections, and wherein the display presents, for a respective MDI canister, a number of doses remaining, time to next actuation, frequency of delivery and delivery status.

16. The system of claim 1, wherein the at least one pMDI canister is a plurality of pMDI canisters that can be serially and selectively actuated by the at least one actuator, the system further comprising an automated agitator held by the housing that physically, and external to the pMDI canisters, shakes or vibrates a MDI canister prior to actuation to dispense medicine into the gas conduit.

17. The system of claim 1, wherein the control unit operator interface panel provides visual information for each of the at least one MDI canister, wherein said control unit comprises a dosage counter and the visual information comprises a graphic display of a remaining volume or dose amount relative to a full volume capacity, and wherein the visual information comprises information regarding an interval between dosages for each of the at least one MDI canister.

18. The system of claim 1, wherein the operator interface comprises a user input for an interval between dosages for each of the at least one MDI canisters, and wherein the control unit receives data from at least one sensor that continuously monitors the ventilator circuit airflow path during inhalation and exhalation.

19. The system of claim 1, wherein the control unit is configured to populate a database of medical records to provide dispensed medication type, dose frequency and verification of medication dispensed to a patient.

20. The system of claim 1, wherein the control unit is configured to provide electronic data records of patient physiologic parameters including a flow profile that contains peak flow, peak flow timing, patient airway resistance and duration for inhalation and exhalation.

21. An automated medical system for controlling medication dispensed to a ventilator circuit that extends between a mechanical ventilator and a patient, comprising:

a gas conduit having axially opposing first and second ends, each end being in-line with and adapted to attach to spaced apart segments of tubing of the ventilator circuit to form part of the ventilation circuit;

a plurality of pressurized metered dose inhaler (pMDI) canisters held orthogonal to the gas conduit with a dispensing end of a respective pMDI canister held proximate the gas conduit in fluid communication with the ventilator circuit via the gas conduit, wherein a delivery path from the dispensing end of the pMDI canisters is directly into an axially extending flow path that is in-line with of the gas conduit;

at least one actuator in communication with the pMDI canisters to press against the pMDI canisters to release medication from the dispensing end to the gas conduit then into the tubing of the ventilator circuit, wherein the at least one actuator can serially and selectively actuate each pMDI canister;

a housing holding the gas conduit, the pMDI canisters and the at least one actuator;

a control unit operably associated with the at least one actuator and comprising an operator interface configured to allow an operator to adjust dosage and schedule medication dispensing for each of the pMDI canisters and to actuate the at least one actuator to dispense medication from each pMDI canisters to the ventilator circuit at a defined dosage, delivery time and/or frequency, wherein the control unit monitors air pathway flow in the ventilator circuit and is configured to time actuation of the actuator so that medication from the at least one pMDI canister is released from the at least one pMDI canister only during an inspiratory/inhale cycle with gas flow toward the patient, wherein the control unit is further configured to provide electronic data records of patient physiologic parameters including a flow profile that contains peak flow, peak flow timing, patient airway resistance and duration for inhalation and exhalation; and

a display held by the control unit for displaying parameters including number of doses remaining for each of the at least one pMDI canister.

22. The system for a ventilator of claim 21, wherein the control unit further determines a pressure and volume of gas flow through the gas conduit associated with patient airway resistance so that the control unit can determine patient airway resistance and/or a cycle time on reversal of gas flow to assess whether the patient has an impaired ability to intake medicament from pMDI canisters through the lungs, wherein the control unit automatically increases a dosage frequency or dosage amount or both dosage frequency and amount for at least one of the pMDI canisters when the patient is determined to have the impaired ability.

23. The system for a ventilator of claim 21, wherein the display provides visual information for each of the plurality of MDI canisters, wherein at least some of the pMDI canisters comprise different medicines from other pMDI canisters, and wherein the control unit comprises a dosage counter and the visual information comprises information regarding remaining dosages for each of said plurality of MDI canisters including a graphic display of a remaining volume or dose amount relative to a full volume capacity, and wherein the information comprises information regarding an interval between dosages for each of the pMDI canisters.