Automatic aerosol medication delivery system and methods

• US 5,394,866 A
• Filed: 01/29/1993
• Issued: 03/07/1995
• Est. Priority Date: 03/05/1991
• Status: Expired due to Fees

• Current Assignee: Aradigm Corporation
• Original Assignee: Aradigm Corporation
• Inventors: Rubsamen, Reid M., Ritson, Carl
• Primary Examiner(s): Burr, Edgar S.
• Assistant Examiner(s): Lewis, Aaron J.
• Application Number:
  US08/002,507
• Time in Patent Office: 767 Days
• Field of Search: 128/200.14, 128/200.23, 128/203.12, 128/202.22, 128/204.21, 128/204.23, 128/204.26, 128/205.23
• US Class Current: 128/200.14
• CPC Class Codes: A61J 7/0418 with electronic history memory
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0066 with means for varying the dose size
• CPC Class Codes: A61M 15/0068 Indicating or counting the number of dispensed doses or of remaining doses
• CPC Class Codes: A61M 15/008 Electronic counters
• 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 15/0091 mechanically breath-triggered
• CPC Class Codes: A61M 15/0093 without arming or cocking, e.g. acting directly on the delivery valve
• CPC Class Codes: A61M 15/0098 Activated by exhalation
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 16/202 electrically actuated
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/60 with identification means
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6027 Electric-conductive bridges closing detection circuits, with or without identifying elements, e.g. resistances, zener-diodes
• CPC Class Codes: A61M 2205/6036 characterised by physical shape, e.g. array of activating switches
• CPC Class Codes: A61M 2205/6045 : having complementary physical shapes for indexing or registration purposes
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2205/8212 : with means or measures taken for minimising energy consumption
• CPC Class Codes: B01F 23/2132 : using nozzles
• CPC Class Codes: B01F 35/71 : Feed mechanisms with proportioning B01F35/80
• CPC Class Codes: B01F 35/7179 : using sprayers, nozzles or jets
• CPC Class Codes: F16H 35/00 : Gearings or mechanisms with other special functional features
• CPC Class Codes: G01F 1/363 : with electrical or electro-mechanical indication G01F1/37 and G01F1/38 take precedence
• CPC Class Codes: G01F 1/40 : Details of construction of the flow constriction devices
• CPC Class Codes: G01F 1/44 : Venturi tubes
• CPC Class Codes: G01F 1/50 : Correcting or compensating means
• CPC Class Codes: G01F 13/006 : measuring volume in function of time
• CPC Class Codes: G01F 15/002 : for gases
• CPC Class Codes: G01F 25/10 : of flowmeters
• CPC Class Codes: G01F 7/005 : by measuring pressure or differential pressure, created by the use of flow constriction

Abstract

A portable, battery powered, hand-held system for releasing a controlled dose of aerosol medication for inhalation by a patient including a durable body and a medication cassette inserted in the durable body. The cassette includes a housing for containing a canister of medication, bears an identification code, and permits the canister to be manually depressed to release a dose, e.g., a metered dose, when out of the durable body. The durable body includes an actuator mechanism for engaging an inserted cassette and its canister, and an actuator release mechanism for controlling the actuator mechanism to depress the canister for a selected period of time to release the desired dose of medication and then the release the canister. The actuator mechanism, includes a compression spring for depressing the canister and a torsion spring for reloading the compression spring. The torsion spring is reloaded by rotating the cassette from an open position for delivering aerosol to a closed position. The actuator release mechanism includes a motor and trigger pin assembly that controls the release of the compression spring and the torsion spring, and, hence, the time that the canister is depressed.

Claims

1. A system for delivering a controlled amount of medication comprising:

a cassette containing a canister of medication to be delivered and having thereon an identification code, the canister having a depressible valve stem;

a durable body having a flow sensor for sensing inhalation breath flow, means for determining whether or not a sensed inhalation satisfies a flow delivery threshold for releasing an amount of medication, a receptacle for receiving the cassette, an actuator mechanism engageable with the canister in the cassette, and an actuator release mechanism for operating the actuator mechanism to depress controllably the canister and release a dose of medication in response to a sensed inhalation breath flow satisfying the flow delivery threshold;

a driver member for engaging an inserted cassette and its canister, the driver member being translatable along a longitudinal first axis and rotatable about the first axis;

a first spring element having one portion fixed and a second portion connected to the driver member and being moveable between a loaded condition position and a released condition, wherein the first spring element moving from the loaded condition to the released condition moves the driver element to depress the canister for releasing a dose of medication;

a second spring element having one portion fixed and a second portion connected to the driver member and moveable between a loaded condition and a released condition, wherein the second spring element moving from the loaded condition to the released condition moves the driver member to release the depressed canister and places the first spring element in its loaded condition;

means for maintaining the first and second spring elements in their loaded conditions in response to a sensed flow satisfying the delivery threshold;

means for allowing the first spring element to release and for maintaining the second spring element in the loaded condition;

means for allowing the second spring element to release and placing the first spring element in the loaded condition in response to the release of the amount of medication;

wherein the cassette further comprises a surface for engaging the driver member when the cassette inserted in the durable body, the cassette is rotatable in the receptacle about the first axis between an open and a closed position, and wherein rotating the cassette from the open to the closed position rotates the driver member to place the second spring element in a loaded condition where it is maintained by the maintaining means.

2. The system of claim I wherein the cassette identification code further comprises a first series of protrusions and wherein the durable body further comprises a keyplate in the receptacle having a first series of slots for passing there through the first series of protrusions so that only cassettes having the first series of protrusions can be passed through the keyplate and inserted in the durable body.

3. The system of claim I wherein the cassette further comprises an electronic device containing the identification code and wherein the durable body further comprises means for coupling to the electronic device and obtaining therefrom the identification code.

4. The system of claim 3 wherein the identification code includes information corresponding to the number of unit dosages of medication contained in the canister of the cassette when the canister is full.

5. The system of claim 3 wherein the identification code includes information corresponding to the number of unit dosages of medication that have been delivered from the canister.

6. The system of claim i wherein the cassette further comprises a first protrusion and the durable body receptacle further comprises a first groove for receiving the first protrusion, thereby guiding the cassette into the receptacle.

7. The system of claim 6 wherein the durable body receptacle further comprises a latch for engaging the first protrusion and locking the cassette in the receptacle, and means for disengaging the latch from the protrusion for removing the cassette from the receptacle.

8. The apparatus of claim I wherein the actuator mechanism has a cocked position and an uncocked position, the actuator release mechanism changes the actuator mechanism from the cocked to the uncocked position to release an amount of aerosol, and the cassette further comprises:

a mouthpiece having an opening,

a valve stem receptacle for receiving the canister valve stem,

a nozzle for directing an aerosol through the mouthpiece opening, and

a housing having a cavity for receiving the canister and engaging the actuator mechanism, wherein the cassette is moveable between an open position for releasing a dose of aerosol and a closed position, and movement from the open to the closed positions places the actuator mechanism in the cocked position.

9. The system of claim 8 wherein the cassette housing fully encloses the canister inside the housing.

10. The system of claim 9 wherein the cassette housing further comprises an aperture positioned to allow for manually depressing the canister.

11. A system for delivering a controlled amount of medication comprising:

a cassette containing a canister of medication to be delivered and having thereon an identification code, the canister having a depressible valve stem;

a durable body having a flow sensor for sensing inhalation breath flow, means for determining whether or not a sensed inhalation satisfies a flow delivery threshold for releasing an amount of medication, a receptacle for receiving the cassette, an actuator mechanism engageable with the canister in the cassette, and an actuator release mechanism for operating the actuator mechanism to depress controllably the canister and release a dose of medication in response to a sensed inhalation breath flow satisfying the flow delivery threshold;

a cam follower fixed in the body;

a movable cam element having a helical face cam surface engaged with the cam follower for rotation about the first axis and a radial slot extending through a portion of the movable cam element periphery;

a driver in slidable contact with the movable cam element having a drive dog for engaging the movable cam element and rotating the movable cam element about the first axis, a first and second protrusions for engaging an inserted cassette, and a surface for engaging the canister in the cassette;

a compression spring having one end fixed and the other end connected to the moveable cam element having a loaded condition in compression and a released condition, the compression spring translating the helical cam, release ring, and river in the first axis from a first position to a second position;

a torsion spring having one end fixed and the other end connected to the movable cam element having a loaded condition in torsion and a released condition, the torsion spring moving from the loaded condition to the released condition to rotate the movable cam element face cam surface against the cam follower to rotate and translate the movable cam element from the second position to a third position and place the first spring element in the loaded condition;

a lever mounted to the body;

a trigger pin mounted on the lever, the trigger pin having a first surface for engaging the movable cam element and a second surface for engaging the slot;

a motor for controlling the movement of the lever between a first stage position with the first surface of the trigger pin engaged in contact with the movable cam element so as to maintain the compression spring in compression and the torsion spring in torsion, a second stage position with the second surface of the trigger pin engaged in the slot to maintain the torsion spring in torsion and allow the compression spring to release and translate the driver from the first to the second positions, and a third stage position with the trigger pin out of engagement with the movable cam element and slot; and

wherein the cassette further comprises a first and second slots for receiving the first and second protrusions of the driver for engagement therewith when the cassette inserted in the durable body, the cassette is rotatable about a longitudinal first axis between an open and a closed position, and wherein rotating the cassette from the open to the closed position rotates the driver so that the drive dog engages the movable cam element and places the torsion spring in torsion and the trigger pin engages the movable cam element in the first stage position.

12. A system for delivering a controlled amount of medication comprising:

a cassette containing a canister of medication to be delivered and having thereon an identification code, the canister having a depressible valve stem;

a durable body having a flow sensor for sensing inhalation breath flow, means for determining whether or not a sensed inhalation satisfies a flow delivery threshold for releasing an amount of medication, a receptacle for receiving the cassette, an actuator mechanism engageable with the canister in the cassette, and an actuator release mechanism for operating the actuator mechanism to depress controllably the canister and release a dose of medication in response to a sensed inhalation breath flow satisfying the flow delivery threshold;

wherein the durable body flow sensor is a tube section having an asymmetrical orifice and a transducer for sensing the pressure in the tube, further;

wherein the durable body flow sensor tube section is comprised of a contoured wall of the durable body and an airway cover having a first end with a first cross-sectional area, a second end having a second cross-sectional area, and a throat having a third cross-sectional area that is less than the first and second cross-sectional areas.

13. The system of claim 12 wherein the flow sensor tube section is calibrated so that different cassettes may be used without affecting the calibration.

14. The system of claim 13 wherein the flow sensor is calibrated for a first range of flow rates for inspiratory flow on the order of 0 to 720 liters per minute and for a second range of flow rates for expiratory flow on the order of 0 to 200 liters per minute.

15. A durable body for releasing a controlled amount of medication in response to a sensed inspiratory flow of a patient comprising:

a channel through a portion of the body;

a sensor for monitoring inhalation breath flow through the channel;

a receptacle for receiving a cassette containing a canister of the aerosol medication to be delivered;

a driver member for engaging an inserted cassette having a longitudinal first axis, a cocked position and an uncocked position, the driver member being translatable along the first axis for moving from the cocked to the uncocked position and rotatable about the first axis for moving from the uncocked to the cocked position;

a first spring element having one end fixed and the other end connected to the driver member and moveable between a loaded condition and a released condition, wherein the first spring element moving from the loaded condition to the released condition moves the driver member from the cocked position to a first uncocked position for releasing a dose of medication;

a second spring element having one end fixed and the other end connected to the driver member and moveable between a loaded condition and a released condition, wherein the second spring element moving from the loaded condition to the released condition moves the driver member from the first uncocked position to a second uncocked position and said movement places the first spring element in its loaded condition;

an actuator release mechanism having a first condition for maintaining the first and second spring elements in their loaded conditions, a second condition for allowing the first spring element to release and for maintaining the second spring element in its loaded condition, and a third condition for allowing the second spring element to release for placing the first spring element in the loaded condition;

means for determining when a sensed inspiratory flow satisfies a preselected delivery threshold; and

means for operating the actuator release mechanism to change from the first to the second conditions in response to a sensed flow satisfying a preselected delivery threshold.

16. The apparatus of claim 15 wherein the first spring element is a compression spring having a loaded condition in compression.

17. The apparatus of claim 15 wherein the driver member further comprises a helical face cam, the body further comprises a cam follower for engaging the face cam, wherein the second spring element moves from the loaded condition to the released condition to move the drive member face cam against the cam follower to rotate and translate the driver member from the first uncocked position to the second uncocked position.

18. The apparatus of claim 17 wherein the second spring element is a torsion spring having a loaded condition in torsion.

19. The apparatus of claim 18 wherein the first spring element is a compression spring having a loaded condition in compression.

20. The apparatus of claim 19 wherein the actuator release mechanism further comprises:

a first element for engaging the driver member to maintain the compression spring in compression with the driver member in the first position;

a second element for engaging the driver member to maintain the torsion spring in torsion and to allow the compression spring to release and the driver member to translate relative to the second element from the cocked position to the first uncocked position;

a first means for controlling the movement of the first element into and out of engagement with the driver member; and

a second means for controlling the movement of the second element into and out of engagement with the driver member.

21. The apparatus of claim 20 wherein the first and second elements further comprise a trigger pin having respective first and second surfaces, and the first and second controlling means further comprise a lever on which the trigger pin is mounted and a motor for controlling movement of the trigger pin between a first stage position with the first surface of the trigger pin engaged to maintain the driver member in the cocked position, a second stage position with the second surface of the trigger pin engaged to allow the driver member to move from the cocked to the first uncocked position, and a third stage position with the trigger pin out of engagement with the driver member.

22. The apparatus of claim 21 wherein the motor further comprises a lead screw rotatable about a second axis in response to driving the motor, a restraining element having a surface for engaging the lever and an edge for engaging the lead screw and translating along the second axis in response to movement of the lead screw by the motor, and a spring for urging the restraining element against the lever, wherein the operating means operates the motor to rotate the lead screw to control movement of the trigger pin.

23. The apparatus of claim 22 wherein the lever further comprises a compound lever having a main lever connected to the body and receiving the trigger pin and a secondary lever connected to the main lever and the body and having the surface for engaging the restraining element.

24. The apparatus of claim 22 wherein the motor lead screw further comprises a multi-start thread.

25. A system for delivering a controlled amount of medication comprising:

a cassette containing a canister of medication to be delivered and having thereon an identification code, the canister having a depressible valve stem;

a durable body having a flow sensor for sensing inhalation breath flow, means for determining whether or not a sensed inhalation satisfies a flow delivery threshold for releasing an amount of medication, a receptacle for receiving the cassette, an actuator mechanism engageable with the canister in the cassette, and an actuator release mechanism for operating the actuator mechanism to depress controllably the canister and release a dose of medication in response to a sensed inhalation breath flow satisfying the flow delivery threshold;

wherein the body further comprises a pair of cam followers and the driver member further comprises;

a second body having a helical face cam surface for rotation about the first axis against the cam followers;

an annular ring in axial alignment with the helical cam having a radial slot extending through a portion of the groove, the second body being connected to the ring by a keyed interconnection;

a driver in axial alignment and slidable contact with the ring for engaging an inserted cassette and having a drive dog for engaging the second body and rotating the helical face cam about the first axis;

a compression spring connected to the second body having a loaded condition in compression and an unloaded condition and movable there between the translating the second body, ring and driver in the first axis between a cocked position and a first uncocked position;

a torsion spring connected to the second body having a loaded condition in torsion and an unloaded condition and moveable from the loaded condition to the released condition to move the helical face cam against the cam followers to rotate and translate the second body and ring from the first uncocked position to a second uncocked position and place the first spring element in the loaded condition.

26. The apparatus of claim 25 wherein the actuator release mechanism further comprises:

a lever mounted on the body;

a trigger pin mounted on the lever, the trigger pin having a first surface for engaging the ring and a second surface for engaging the ring slot;

a motor for controlling the movement of the lever between a first stage position with the trigger pin first surface in contact with the ring, a second stage position with the trigger pin second surface in engagement with the ring slot, and a third stage position with the trigger pin out of engagement with the ring and slot.

27. A method for releasing a controlled amount of medication from a canister in response to a sensed inspiratory flow of a patient comprising:

monitoring the inhalation breath flow through a flow path;

providing a driver member in axial alignment with a canister of medication to be delivered;

connecting a first spring to the driver member for translating the driver member along a first axis;

connecting a second spring to the driver member for rotating the driver member about the first axis;

placing the driver member in a cocked position with the first and second springs in a loaded condition so that driver member does not move;

determining that the sensed flow satisfies a selected delivery threshold and releasing the first spring and retaining the second spring in a loaded condition to translate the driver element to a first uncocked position, thereby to release a dose of medication; and

subsequently releasing the second spring to rotate the driver member to return the first spring to a loaded condition and retaining the driver element in a second uncocked position with the first spring in a loaded condition.

28. The method of claim 27 further comprising providing the first spring as a compression spring and providing the second spring as a torsion spring and wherein the step of placing the driver member in the cocked position further comprises engaging the driver member with a pin to prevent the driver member from translating and rotating.

29. The method of claim 28 wherein releasing the second spring further comprises providing the driver member with a helical face cam, providing the body with a cam follower for engaging the helical face cam, and moving the pin out of engagement with the driver member so that the torsion spring releases, causing the driver element helical face cam to rotate about the first axis and to rotate and translate the driver member from the second uncocked position to a third uncocked position and place the compression spring in a loaded condition.

30. The method of claim 29 wherein the steps of moving the pin further comprise:

providing a lever;

a mounting the pin on the lever;

biasing the lever and pin in engagement with the driver member;

controlling the movement of the pin out of engagement with the driver member in response to the sensed flow satisfying the predetermined delivery threshold so that the compression spring releases and thereafter the torsion spring releases.

31. The method of claim 30 wherein the steps of controlling the movement of the pin further comprise:

providing a motor having a lead screw rotatable about a second axis in response to driving the motor;

providing a restraining element having a surface for contacting the lever and an edge for engaging the lead screw;

providing a spring for biasing the restraining element in contact with the lever;

engaging the restraining element edge in a thread of the lead screw when the driver member is engaged with the pin;

operating the motor to rotate the lead screw to control the movement of the restraining element along the second axis to control release of the compression spring and the torsion spring in sequence.

32. An intrapulmonary drug delivery device, for delivering medication from a cassette body containing a pressurized canister containing a pharmaceutically active drug and a propellant and having a valve thereon comprising:

a main body member;

a flow channel formed in the main body;

an inhalation breath flow sensor for sensing flow in the channel;

a valve release mechanism for engaging the valved cassette canister and operating the valve;

means for determining when a sensed inhalation breath flow satisfies a predetermined threshold of flow;

means for automatically operating the valve to release an amount of medication in response to a determined sensed inhalation breath flow satisfying the predetermined threshold

a driver member for engaging an inserted cassette having a longitudinal first axis, the driver member being translatable along the first axis and rotatable about the first axis;

a first spring element having one end fixed and the other end connected to the driver member and moveable between a loaded condition and a released condition, wherein the first spring element moving from the loaded condition to the released condition moves the driver element from a first position to a second position for releasing the amount of medication; and

a second spring element having one end fixed and the other end connected to the driver member and moveable between a loaded condition and a released condition, wherein the second spring element moving from the loaded condition to the released condition moves the driver member from the second position to a third position and said movement places the first spring element in its loaded condition.

33. The apparatus of claim 32, wherein the main body further comprises a shaped receptacle for receiving a cassette and a latch for locking the inserted cassette in the receptacle, wherein the cassette body and main body fit together.

34. The apparatus of claim 32, wherein the main body member and cassette body member further comprise respective corresponding electronic components which components must be connected to allow the release of drug from the canister.

35. The device of claim 34 wherein the main body further comprises an electronic component for sensing an identification code contained on the cassette.

36. The apparatus of claim 34, wherein the main body further comprises electric leads for coupling to an electrical power source on the cassette body.

37. The apparatus of claim 36 wherein the automatic operating means further comprises:

means for engaging the first and second spring elements in a first condition for maintaining the first and second spring elements in their loaded conditions, a second condition for allowing the first spring element to release and for maintaining the second spring element in its loaded condition, and a third condition for allowing the second spring element to release for placing the first spring element in the loaded condition;

means for determining when a sensed inspiratory flow satisfies a preselected delivery threshold; and

means for operating the valved canister engaging means mechanism to change from the first to the second conditions in response to a sensed flow satisfying a preselected delivery threshold.

38. The apparatus of claim 37 wherein the operating means further comprises means for maintaining the valved canister engaging means in the second condition for a selected period of time.