Drug dispensing controller and monitoring system for a ventilator

• US 10,639,440 B2
• Filed: 05/19/2017
• Issued: 05/05/2020
• 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:
  US15/600,362
• Publication Number:
  US 20170259017A1
• Time in Patent Office: 1,082 Days
• 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. A method for controlling medication dispensed to a ventilator circuit that extends between a mechanical ventilator and a patient, comprising:

providing a housing comprising at least one pressurized metered dose inhaler (pMDI) canister and coupled to a gas conduit having axially opposing and axially extending first and second elongate conduit segments with respective first and second ends, each of the first and second elongate conduit segments 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;

actuating an actuator in the housing to release medication from the at least one 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 to release medication from the dispensing end to the gas conduit then into the tubing of the ventilator circuit, wherein the actuation of the actuator is timed so that the medication from the at least one pMDI canister is released from the at least one pMDI canister during an inspiratory/inhale cycle with gas flow toward the patient;

monitoring air pathway flow in the ventilator circuit to determine a change in patient airway resistance over time using a controller in communication with at least one sensor coupled to the ventilator circuit, wherein the controller is also in communication with the actuator;

electronically evaluating patient effluent gases in the ventilation circuit;

electronically identifying when a different or additional medication, an increase in dosage and/or a change in scheduled frequency of medication delivered by the at least one pMDI canister is needed based on the determined change in patient airway resistance or the evaluated patient effluent gases or the determined change in patient airway resistance and the evaluated patient effluent gases;

allowing an operator to adjust a defined dosage, delivery time and/or frequency of medication released by the at least one pMDI canister for the actuating; and

displaying parameters including number of doses remaining for each of the at least one pMDI canister on a display in communication with the controller.

2. The method of claim 1, wherein the evaluating is carried out using a spectrometer in fluid communication with the gas conduit to obtain one or more of ultraviolet, optical and/or near-infrared spectra, wherein the method further comprises evaluating the obtained spectra to determine particle size reflectance.

3. The method of claim 1, wherein the evaluating is carried out using obtained spectra of the patient effluent gases to determine deposition.

4. The method of claim 1, wherein the controller 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 the determined change in patient airway resistance.

5. The method of claim 1, wherein the 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 the gas conduit and adjacent segments of the spaced apart segments of the tubing of the ventilator circuit.

6. The method of claim 1, wherein the at least one pMDI canister is a plurality of spaced apart pMDI canisters that are held by the housing, and wherein the actuating is carried out in response to the controller directing the at least one actuator to serially actuate the plurality of pMDI canisters to dispense medication into a common entry location into the gas conduit.

7. The method of claim 1, further comprising decrementing a count of a dosage counter in response to actuation of the actuator or a respective pMDI canister and electronically providing a number of doses remaining for the displaying.

8. The method of claim 1, wherein the at least one pMDI canister is a plurality of pMDI canisters held in the housing, wherein the housing is coupled to the ventilator circuit in close proximity to the patient and the tubing of the ventilator circuit.

9. The method of claim 1, further comprising:

determining a cycle time on reversal of gas flow to determine patient airway resistance to assess whether the patient has an impaired ability to intake medication from the at least one pMDI canister through the lungs; and

automatically increasing a dosage frequency or dosage amount or both dosage frequency and amount for the at least one pMDI canister when the controller determines that the patient has the impaired ability.

10. The method of claim 1, further comprising continuously detecting ventilator circuit conditions and patient airway resistance using the at least one sensor, and modifying a next scheduled bolus of medication delivery by adjusting an interval of actuation of the at least one actuator for the at least one pMDI canister in response to determined patient airway resistance using the controller.

11. The method of claim 1, wherein the controller is coupled to an operator interface that comprises a menu with control and configuration selections, and wherein the displaying the parameters is carried out to display, for a respective pMDI canister, a number of doses remaining, time to next actuation, frequency of delivery and delivery status.

12. The method of claim 1, wherein the displaying the parameters is carried out to display a graphic display of a remaining volume or dose amount relative to a full volume capacity and information regarding an interval between dosages for each of the at least one pMDI canister.

13. The method of claim 1, further comprising continuously monitoring the ventilator circuit airflow path during inhalation and exhalation using the controller and the at least one sensor, wherein the in fluid communication with the gas conduit.

14. The method of claim 1, further comprising electronically populating a database of medical records to provide dispensed medication type, dose frequency and verification of medication dispensed to a patient.

15. The method of claim 1, further comprising electronically providing 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 using the controller.

16. 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 spectrometer in fluid communication with the gas conduit to obtain one or more of ultraviolet, optical and/or near-infrared spectra of patient effluent gas;

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 the gas conduit;

at least one actuator in communication with 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 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 of the 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 patient effluent gases and is configured to time actuation of the actuator so that medication is released from one or more of the at least one pMDI canisters 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; and

a display held by the control unit for displaying parameters including number of doses remaining for each of the pMDI canisters.

17. The system of claim 16, wherein the system evaluates the obtained spectra to determine one or both of (a) particle size reflectance and/or (b) deposition/detection.

18. The system of claim 16, wherein the control unit further determines a pressure and volume of gas flow through the gas conduit associated with patient airway resistance, wherein the control unit determines patient airway resistance and/or a cycle time on reversal of gas flow and evaluates the spectra of the patient effluent gas, and wherein the control unit identifies when additional or different medication, an increase in dosage and/or a change in scheduled frequency of medication delivered by the pMDI canisters is needed based on one or both of the patient airway resistance or the evaluated patient effluent gas.

19. The system of claim 16, wherein the electronic data records of the patient physiologic parameters including the flow profile contains peak flow, peak flow timing, patient airway resistance and duration for inhalation and exhalation,

wherein the display provides visual information for each of the plurality of pMDI canisters, wherein at least one of the pMDI canisters comprises a different medicine from others of the pMDI canisters,

wherein the control unit comprises a dosage counter and the visual information comprises information regarding remaining dosages for each of said plurality of pMDI canisters including a graphic display of a remaining volume or dose amount relative to a full volume capacity.