Compact self-contained automated MDI adapters or units for ventilators

• US 8,869,793 B1
• Filed: 05/18/2011
• Issued: 10/28/2014
• Est. Priority Date: 05/18/2010
• Status: Active Grant

• Current Assignee: iDTx Systems, Inc
• Original Assignee: iDTx Systems, Inc
• Inventors: Spandorfer, Michael, Gilbert, Murphy Pearce
• Primary Examiner(s): DOUGLAS, STEVEN O
• Application Number:
  US13/110,436
• Time in Patent Office: 1,259 Days
• Field of Search: 128/203.14, 128/205.23, 128/202.27, 128/910
• US Class Current: 128/203.14
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• 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 15/0066 with means for varying the dose size
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0081 Locking means
• 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 16/0051 with alarm devices
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/0816 Joints or connectors
• CPC Class Codes: A61M 16/1045 Devices for humidifying or heating the inspired gas by using recovered moisture or heat from the expired gas
• CPC Class Codes: A61M 16/14 by mixing different fluids, one of them being in a liquid phase
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• 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 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/3368 Temperature
• 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 2205/3592 : using telemetric means, e.g. radio or optical transmission
• 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 2205/6009 : for matching patient with his treatment, e.g. to improve transfusion security
• CPC Class Codes: A61M 2205/6054 : Magnetic identification systems
• CPC Class Codes: A61M 2205/6072 : Bar codes
• CPC Class Codes: A61M 2205/609 : Biometric patient identification means
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2209/01 : Remote controllers for specific apparatus
• CPC Class Codes: A61M 2230/43 : Composition of exhalation

Abstract

A portable unit for providing automated delivery of medication to a ventilator circuit that runs between a mechanical ventilator and a patient is provided. The portable unit includes: a housing configured to releasably hold an inhaler containing the medication, wherein the inhaler is in fluid communication with the ventilator circuit; an actuator at least partially in the housing and in communication with the inhaler to deliver medication from the inhaler to the ventilator circuit for a respective patient; a controller programmed to control an amount and/or frequency of medication delivery from the inhaler to the ventilator circuit for a respective patient, the controller configured to actuate the actuator to deliver the medication from the inhaler to the ventilator circuit at the programmed amount and/or frequency; and a display for displaying the amount and/or frequency of medication delivery and an amount of medication remaining in the inhaler, wherein the display is dynamically updated by the controller. Diagnostic devices are also disclosed that: 1) administer an agent to gas to be inhaled; 2) detect/measure exhaled gas; and/or 3) determine a state or condition of a patient based on the detected/measured exhaled gas.

Claims

1. A portable control unit for providing automated delivery of medication to a ventilator circuit that extends between a mechanical ventilator and a patient, comprising:

a housing releasably attached to the ventilator circuit, the housing releasably holding an end portion of at least one inhaler containing medication such that a major portion of the inhaler extends outside the housing, wherein the inhaler includes an outlet nozzle that is opposite the end portion and is received through an entry port in the ventilator circuit that is outside the housing such that the inhaler is in fluid communication with the ventilator circuit;

an actuator held by the housing and in communication with the inhaler to direct the inhaler to release medication to the ventilator circuit for the patient, wherein the actuator is disposed adjacent the end portion of the inhaler that is opposite the outlet nozzle;

a controller held by the housing, the controller configured to control an amount and/or frequency of medication delivery from the inhaler to the ventilator circuit for the patient and to actuate the actuator to deliver medication from the inhaler to the ventilator circuit at a defined amount and/or frequency; and

a display held by the housing for displaying parameters including the defined amount and/or frequency of medication delivery and an amount of medication remaining in the inhaler, wherein the controller is configured to dynamically update the displayed parameters;

wherein the portable control unit is a compact, lightweight standalone device that is releasably attached to the ventilator circuit by at least one holding member that at least partially surrounds the ventilator circuit and holds the housing in place such that the housing is adjacent and/or on the ventilator circuit with the ventilator circuit extending completely outside the housing.

2. The portable control unit of claim 1, further comprising a user interface held by the housing to allow an operator to input to the controller the amount and/or frequency of medication delivery from the inhaler to the ventilator circuit for the patient.

3. The portable control unit of claim 1, further comprising a caregiver-initiated manual override control in communication with the controller to direct the actuator to deliver medication from the inhaler to the ventilator circuit for the patient irrespective of the defined amount and/or frequency of medication delivery.

4. The portable control unit of claim 1, further comprising a patient-initiated manual override control in communication with the controller to direct the actuator to deliver medication from the inhaler to the ventilator circuit for the patient irrespective of the defined amount and/or frequency of medication delivery.

5. The portable control unit of claim 1 in combination with a connector that forms a portion of the ventilator circuit and includes an entry port to receive the nozzle of the inhaler therethrough such that medication is delivered from the inhaler to an interior of the connector when the actuator is actuated, the combination further comprising a gas flow sensor disposed in the interior of the connector, the gas flow sensor configured to detect a gas flow direction through the connector and communicate the gas flow direction to the controller, wherein the portable control unit is releasably attached to the connector by the at least one holding member that at least partially surrounds the connector and holds the housing in place such that the housing is adjacent and/or on the connector with the connector extending completely outside the housing.

6. The combination of claim 5, wherein the controller is configured to actuate the actuator when the gas flow direction in the connector is from the ventilator to the patient based on data detected by the gas flow sensor.

7. The combination of claim 5, wherein the gas flow sensor is configured to detect at least one gas flow characteristic of gas flowing through the connector and to communicate the detected at least one gas flow characteristic to the controller, and wherein the controller is configured to adjust the amount and/or frequency of medication delivery in response to the detected at least one gas flow characteristic.

8. The portable control unit of claim 1, wherein the controller is configured to:

(i) lock the unit to prevent actuation of the actuator and prevent unwanted adjustment of operational parameters;

(ii) receive identification information associated with an operator of the unit;

(iii) verify that the operator is an authorized user based on the identification information; and

(iv) unlock the unit and actuate the actuator to deliver medication from the inhaler to the ventilator circuit in response to verification that the operator is an authorized user.

9. The portable control unit of claim 1, wherein the controller is configured to:

(i) lock the unit to prevent actuation of the actuator and prevent unwanted adjustment of operational parameters;

(ii) receive identification information associated with a patient;

(iii) verify that the patient is to receive the medication contained in the inhaler based on the identification information; and

(iv) unlock the unit and actuate the actuator to deliver medication from the inhaler to the ventilator circuit in response to verification that the patient is to receive the medication contained in the inhaler.

21. The portable control unit of claim 1, wherein the controller is configured to:

(i) lock the unit to prevent actuation of the actuator and prevent unwanted adjustment of operational parameters;

(ii) receive identification information associated with the patient;

(iii) electronically identify the inhaler that is held by the housing;

(iv) verify that the patient is to receive the medication contained in the inhaler based on the identification information associated with the patient and the electronic identification of the inhaler; and

(v) unlock the unit and actuate the actuator to deliver medication from the inhaler to the ventilator circuit in response to verification that the patient is to receive the medication contained in the inhaler.

10. A system for providing automated delivery of medication to a ventilator circuit that extends between a mechanical ventilator and a patient, comprising:

a connector that resides in-line with a portion of the ventilator circuit; and

a compact and/or lightweight portable control unit releasably attached to the connector, the portable control unit comprising;

a housing releasably held holding an upper end portion of at least one inhaler containing medication such that a major portion of the inhaler extends outside the housing, wherein the inhaler includes an outlet nozzle residing below and opposite the upper end portion that is received through an entry port in the connector such that the inhaler is in fluid communication with the ventilator circuit;

an actuator held by the housing and in communication with the inhaler to direct the inhaler to release medication to the ventilator circuit for the patient, wherein the actuator is disposed adjacent an end of the inhaler that is opposite the outlet nozzle; and

a controller configured to control an amount and/or frequency of medication delivery from the inhaler to the ventilator circuit for a respective patient and to actuate the actuator to deliver the medication from the inhaler to the ventilator circuit at a defined amount and/or frequency;

wherein the lightweight portable control unit is releasably attached to the connector such that the housing is adjacent and/or on the connector with the connector extending completely outside the housing.

11. The system of claim 10, wherein the unit further comprises a user interface held by the housing to allow an operator to input to the controller the amount and/or frequency of medication delivery from the inhaler to the ventilator circuit for a respective patient.

12. The system of claim 10, wherein the unit further comprises a manual override control in communication with the controller to direct the actuator to actuate to deliver medication from the inhaler to the ventilator circuit for a respective patient irrespective of the defined amount and/or frequency of medication delivery.

13. The system of claim 10, further comprising a gas flow sensor disposed in the connector, the gas flow sensor configured to detect a gas flow direction through the connector and communicate the gas flow direction to the controller, wherein the controller is configured to actuate the actuator in response to the gas flow sensor detecting a gas flow direction from the ventilator to the patient.

14. The system of claim 13, wherein the gas flow sensor is configured to detect at least one gas flow characteristic of gas flowing through the connector and to communicate the detected gas flow characteristic to the controller, and wherein the controller is configured to adjust the amount and/or frequency of medication delivery in response to the detected at least one gas flow characteristic.

15. The system of claim 14, wherein the unit further comprises a display for displaying parameters including the defined amount and/or frequency of medication delivery and an amount of medication remaining in the inhaler, wherein the controller is configured to dynamically update the displayed parameters.

22. The system of claim 10, wherein the lightweight portable control unit is releasably attached to the connector by at least one holding member that at least partially surrounds the connector and holds the housing in place.

16. A diagnostic system for use with a ventilator circuit that runs between a mechanical ventilator and a patient, comprising:

at least one housing releasably holding (i) a container containing diagnostic particles to be inhaled by the patient and (ii) an inhaler containing medication, wherein at least a portion of each of the container and the inhaler are held outside the housing, and wherein each of the container and the inhaler are in fluid communication with the ventilator circuit;

a first actuator at least partially in the at least one housing and in communication with the container to deliver particles to be inhaled by the patient from the container to the ventilator circuit at a location that is outside the housing;

an exhaled gas measurement sensor disposed in the ventilator circuit configured to perform a measurement on gas exhaled from the patient after the particles have been inhaled by the patient;

a second actuator held by the at least one housing and in communication with the inhaler to direct the inhaler to release medication to the ventilator circuit for the patient at a location that is outside the housing; and

at least one controller held by the at least one housing, the controller configured to;

(i) actuate the first actuator to deliver the particles to be inhaled by the patient from the container to the ventilator circuit, to receive the measurement on gas subsequently exhaled by the patient from the exhaled gas measurement sensor, and to determine a current state or condition of the patient in response to the received measurement; and

(ii) control an amount and/or frequency of medication delivery from the inhaler to the ventilator circuit for the patient, to actuate the second actuator to deliver the medication from the inhaler to the ventilator circuit at a defined amount and/or frequency, and to adjust the defined amount and/or frequency of medication delivery in response to the determined current state or condition of the patient;

wherein the at least one housing is attached to the ventilator circuit such that the at least one housing is adjacent and/or on the ventilator circuit with the ventilator circuit extending completely outside the at least one housing.

17. The diagnostic system of claim 16, wherein

the at least one housing includes:

a first housing holding the container such that at least a major portion of the container is outside the first housing, wherein the first actuator is at least partially in the first housing; and

a second housing holding the inhaler such that at least a major portion of the inhaler is outside the second housing, wherein the second actuator is at least partially in the second housing.

18. The diagnostic system of claim 16, further comprising a display for displaying information including the defined amount of medication delivery and/or frequency of medication delivery, an amount of medication remaining in the inhaler, and parameters associated with the determined state or condition of the patient, wherein the controller dynamically updates the displayed information.

19. A connector for use with a ventilator circuit that runs between a mechanical ventilator and a patient for evenly releasing medication from an inhaler into the ventilator circuit, comprising:

an outer fluid channel in fluid communication with the inhaler and configured to contain medication from the inhaler therein;

an inner fluid channel radially spaced-apart from and in fluid communication with the outer fluid channel, wherein the inner fluid channel forms a portion of the ventilator circuit;

a wall separating the outer fluid channel and the inner fluid channel; and

a plurality of perforations in the wall;

wherein, when gas flows through the ventilator circuit in a direction from the ventilator to the patient, medication contained in the outer fluid channel is released through the perforations, into the inner fluid channel, and into the gas in the ventilator circuit to the patient;

wherein the outer fluid channel and the inner fluid channel are concentric.

20. The connector of claim 19 in combination with a controller and a gas flow sensor disposed in the ventilator circuit configured to detect a gas flow direction through the ventilator circuit and communicate the gas flow direction to the controller, wherein the controller is configured to actuate the inhaler to release medication therefrom to the outer fluid channel after detection by the gas flow sensor of a gas flow direction from the patient to the ventilator and before detection by the gas flow sensor of a gas flow direction from the ventilator to the patient.