Source: https://patents.google.com/patent/US20110061646
Timestamp: 2018-03-22 06:47:11
Document Index: 226414807

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 61', 'Application No. 61', 'application no. 0518355', 'art 12', 'art 10', 'art 10', 'art 12', 'art 12', 'art 412', 'art 12', 'art 412', 'art 490', 'art 490', 'arts 412', 'art 490', 'arts 412', 'art 412', 'art 490', 'art 490', 'art 490', 'art 412', 'art 10', 'arts 10', 'art 12', 'art 10', 'art 12', 'art 12', 'arts 10', 'art 12', 'Application No. 60', 'art 10', 'art 10', 'art 10', 'art 210', 'art 10', 'art 10', 'art 10', 'art.\n1', 'art.\n48', 'art.\n51']

US20110061646A1 - Drug dispenser - Google Patents
US20110061646A1
US20110061646A1 US12674063 US67406308A US2011061646A1 US 20110061646 A1 US20110061646 A1 US 20110061646A1 US 12674063 US12674063 US 12674063 US 67406308 A US67406308 A US 67406308A US 2011061646 A1 US2011061646 A1 US 2011061646A1
US12674063
US8820318B2 (en )
One aspect provides a drug dispenser device comprising a housing; extending from the housing, an outlet for insertion into a body cavity of a patient; provided to the housing and moveable with respect thereto, a drug discharge device having a longitudinal axis and comprising a container for storing a drug formulation to be dispensed, a discharge mechanism and a discharge channel from the container for discharge of the drug formulation to the outlet; connecting to the container, a container collar connected to the discharge device; connecting to the container collar and moveable with respect thereto along the longitudinal axis of the drug discharge device; connecting to the container collar and moveable with respect thereto along the longitudinal axis of the drug discharge device, a transfer element including an actuating portion; provided to the housing, at least one finger operable member moveable to apply an actuating force to the actuating portion of the transfer clement to move the transfer element from an initial position along the longitudinal axis in a first direction; provided to the container collar, a pre-load mechanism to prevent transfer of the actuating force to the container collar to move the drug discharge device along the longitudinal axis in the first direction to actuate the discharge mechanism until a pre-determined threshold force is overcome; and connecting the container collar with the transfer element, a biasing return mechanism acting to bias the transfer element along the longitudinal axis in a second direction to return the transfer element to its initial position.
The present patent application claims priority from U.S. Provisional Application No. 60/956,950 filed on 21 Aug. 2007, which is incorporated herein by reference in entirety.
The disclosures of U.S. Provisional Applications Nos. 60/823,134, 60/823,139, 60/823,141, 60/823,143, 60/823,146, 60/823,151 and 60/823,154, all filed on 22 Aug. 2006; U.S. Provisional Application No. 60/894,537 filed on 13 Mar. 2007; U.S. Provisional Application No. 60/956,947 filed 21 Aug. 2007, U.S. Provisional Application No. 61/029,458 filed on 18 Feb. 2008 and U.S. Provisional Application No. 61/035,872 filed 12 Mar. 2008, all commonly owned, are incorporated herein by reference in their entirety.
The disclosures of the International (PCT) Patent Applications WO-A-2008/023018, WO-A-2008/023019, WO-A-2008/023017, WO-A-2008/023015, WO-A-2008/023014, WO-A-2008/023013, and WO-A-2008/024728 which designate the United States of America and claim priority from the aforementioned U.S. Provisional Application Nos. 60/823,134, 60/823,139, 60/823,141, 60/823,143, 60/823,146, 60/823,151 and 60/823,154 are also incorporated herein by reference in their entirety.
The disclosure of International (PCT) Patent Application PCT/EP2008/052967 which designates the United States of America and claims priority from the aforementioned U.S. Provisional Application Nos. 60/894,537 and 60/956,947 is also incorporated herein by reference in its entirety.
It is known to provide a drug dispenser, in which a drug dose is dispensed via a mouthpiece or nozzle upon the application of a force by a user to an actuating lever or similar actuating members. Typically, displacement of the actuating lever is arranged to transfer actuating force to a dispensing mechanism (e.g. a valve or pump) provided to a drug container, which results in dispensing of a drug dose. Such dispensers may be arranged to dispense a single dose or may alternatively be arranged with a reservoir containing several doses to be dispensed.
If the actuating lever is moved in a slow, insufficiently strong, unpredictable or otherwise inadequate manner the drug may not be caused to effectively dispensed.
A drug dispenser of embodiments provided herein includes a ‘commitment’ feature, which allows transfer of actuating force from the actuator lever to the dispensing mechanism, and optionally to any included actuation counter, only when a pre-determined threshold force has been exceeded. This provides assurance of effective dispensing of drug and, where a counter is present, reliable counting of that dispensing, which is only permitted to occur in response to sufficient actuating force having been provided by the patient to the actuating lever to overcome the pre-determined threshold.
The present invention in aspects thereof proposes to provide a drug dispenser that provides more efficient dispensing of drug, and in particular, one that prevents ineffective dispensing of drug as a result of inadequate patient actuation.
The housing may have any suitable form but is in embodiments sized and shaped for ready accommodation by the hand of a patient. In particular, the housing is sized and shaped to enable one-handed operation of the dispenser device.
Extending from the housing, there is provided an outlet for insertion into a body cavity of a patient. Where the patient body cavity is the mouth of a patient, the outlet is generally shaped to define a mouthpiece. Where the patient body cavity is the nose of a patient, the outlet is generally shaped in nozzle form for receipt by a nostril of the patient. The outlet may be provided with a removeable protective cover such as a mouthpiece cover or nozzle cover.
Provided to the housing and moveable with respect thereto, there is a drug discharge device. The drug discharge device has a longitudinal axis and comprises a container for storing a drug formulation to be dispensed. In embodiments, the container adopts a generally cylindrical form and the longitudinal axis is defined by the central axis of the cylinder. The container is in embodiments arranged to have a neck at one end.
The container is provided with a discharge mechanism, which communicates with a discharge channel extending from the container for discharge of the drug formulation to the outlet of the dispenser device. In embodiments, the discharge channel extends out from a neck of the container.
Typically, the discharge mechanism is provided with a spring mechanism (or other biasing mechanism) that provides a degree of bias that must be overcome in order to allow discharge of drug from the discharge mechanism. Typically, that spring mechanism also acts as a return mechanism to return the discharge mechanism to its rest state after firing thereof.
In embodiments, the discharge channel is received by a cavity or passage provided to a part (e.g. block form) of the housing, which cavity or passage enables communication with the outlet for dispensing of discharged drug to a patient.
In one embodiment, where the discharge channel is the valve stem of a valved aerosol canister, the valve stem is received within a stem block provided to the housing, which stem block includes a passage which acts such as to channel discharged aerosolized drug from the valve stem to the outlet.
In another embodiment, where the discharge channel is the discharge tube of a fluid pump discharge device, the discharge tube is received within a discharge tube block provided to the housing, which discharge tube block includes a passage which acts such as to guide discharged fluid drug from the discharge tube to the outlet.
In one embodiment, the drug discharge device is suitable for dispensing aerosolized drug and thus, generally comprises an aerosol canister provided with a discharge valve of the type well-known for use in metered dose inhaler (MDI) type drug dispensers. The canister is generally formed of metal (e.g. aluminium). The valve generally includes a return spring such that once the valve has been fired it is returned to an ‘at rest’ position ready for subsequent firing thereof.
In a metered dose inhaler (MDI) the discharge device is for dispensing drug in aerosol form, wherein the drug is comprised in an aerosol container suitable for containing a propellant-based aerosol drug formulation. The aerosol container is typically provided with a metering valve, for example a slide valve, which acts as the discharge mechanism for release of the aerosol form drug formulation to the patient. The aerosol container is generally designed to deliver a predetermined dose of drug upon each actuation by means of the valve, which can be opened by compressing the valved container, for instance by depressing the valve while the container is held stationary or by depressing the container while the valve is held stationary.
Typically, the valve is a metering valve. The metering volumes are typically from 10 to 100 μl, such as 25 μl, 50 μl or 63 μl. In embodiments, the valve body defines a metering chamber for metering an amount of drug formulation and an open/close mechanism by means of which the flow through the inlet port to the metering chamber is controllable. Preferably, the valve body has a sampling chamber in communication with the metering chamber via a second inlet port, said inlet port being controllable by means of an open/close mechanism thereby regulating the flow of drug formulation into the metering chamber.
The valve may also comprise a ‘free flow aerosol valve’ having a chamber and a valve stem extending into the chamber and movable relative to the chamber between dispensing and non-dispensing positions. The valve stem has a configuration and the chamber has an internal configuration such that a metered volume is defined therebetween and such that during movement between its non-dispensing and dispensing positions the valve stem sequentially: (i) allows free flow of aerosol formulation into the chamber, (ii) defines a closed metered volume for pressurized aerosol formulation between the external surface of the valve stem and internal surface of the chamber, and (iii) moves with the closed metered volume within the chamber without decreasing the volume of the closed metered volume until the metered volume communicates with an outlet passage thereby allowing dispensing of the metered volume of pressurized aerosol formulation.
In embodiments any of the inner parts of the valve (e.g. those which in use, will contact the drug formulation) are coated with material (e.g. fluoropolymer material) that reduces the tendency of drug to adhere thereto. Suitable fluoropolymer materials include polytetrafluoroethylene (PTFE) and fluorinated ethylene-propylene co-polymer (FEP). Any movable parts may also have coatings applied thereto, which enhance their desired movement characteristics. Frictional coatings may therefore be applied to enhance frictional contact and lubricants used to reduce frictional contact as necessary.
In another embodiment, the drug discharge device is a fluid discharge device suitable for dispensing of fluid drug formulation (e.g. non-pressurised/propellant-free) and thus, generally comprises a fluid container provided with a compression pump. Such pumped discharge devices are most commonly used in dispensers for dispensing fluid form drug for nasal delivery.
A suitable pre-compression pump would be a VP3, VP7 or modifications, model manufactured by Valois SA. Typically, such pre-compression pumps are typically used with a bottle (glass or plastic) container capable of holding 8-50 ml of a formulation. Each spray will typically deliver 50-100 μl of such a formulation and the device is therefore capable of providing at least 100 metered doses.
The container collar is in embodiments in essentially fixed relationship with (i.e. it fixes to) the drug discharge device, e.g. the container. In embodiments, the container collar engages (e.g. in essentially fixed relationship) with a neck of the container.
The container collar may engage with the drug discharge device, e.g. (the neck of) the container, by any suitable permanent or temporary engagement including a snap-fit engagement mechanism. Preferably, as in the illustrated embodiments hereinafter, the container collar is permanently connected to the container through use of a split-ring collar as described in U.S. patent application Ser. No. 10/110,611 (WO-A-01/28887) and US-A-2006/0082039.
There is further provided a transfer element that is arranged to interact (e.g. directly) with the container collar and is moveable with respect thereto along the longitudinal axis of the drug discharge device. The transfer element may have any suitable form but preferably comprises an extension collar that is sized and shaped for receipt by the container and arranged in suitable fashion relative to the container collar. In one preferred embodiment, the extension collar is sized and shaped for receipt around (i.e. external to) the container collar.
The transfer element includes an actuating portion. The actuating portion is shaped for interaction with the at least one finger operable member, and may take any form that facilitates and accommodates that interaction including abutment (e.g. flange or shelf), rack and pinion gear and indent forms. In embodiments, the actuating portion defines an abutment surface (e.g. a shelf provided thereto).
The housing is provided with the at least one finger operable member. Preferably, the at least one finger operable member is moveable transversely with respect to the longitudinal axis of the drug discharge device. In alternative embodiments, the at least one finger operable member may therefore directly contact the actuating portion of the transfer element or be coupled thereto to enable the necessary transfer of force.
The at least one finger operable member is in embodiments shaped for direct interaction with the actuating portion, and may take any form that facilitates and accommodates that direct interaction including abutment and indent forms. In embodiments, the at least one finger operable member defines a bearing surface arranged for interaction with the actuating portion of the transfer element.
The term at least one finger operable member is meant to encompass such members operable by action of the finger or thumb, or combinations thereof of a typical user (e.g. an adult or child patient).
In embodiments, the at least one finger operable member is arranged to apply mechanical advantage. That is to say, the at least one finger operable member applies mechanical advantage to the user force to adjust (generally, to enhance or smooth) the force experienced by the transfer element. The mechanical advantage may in one embodiment, be provided in either a uniform manner such as by a constant mechanical advantage enhancement, for example by a ratio of from 1.5:1 to 10:1 (enhanced force:initial force), more typically from 2:1 to 5:1. In another embodiment, the mechanical advantage is applied in a non-constant manner such as progressive increase or progressive decrease of mechanical advantage over the applied force cycle. The exact profile of mechanical advantage variation may be readily determined by reference to the desired dispensing performance of the dispenser device.
Preferably, the at least one finger operable member comprises of at least one lever pivotally connected to part of the housing and arranged to transfer force to the transfer element (e.g. acting directly thereupon) so as to urge the transfer element in the first direction when the or each lever is moved by a user.
In one preferred embodiment, there are two opposing levers, each of which pivotally connect to part of the housing and may be arranged to act upon the transfer element so as to urge the transfer element in the first direction when the two levers are squeezed together by a user.
In one embodiment, the movement of the two opposing levers is coupled, which coupling acts to wholly or partly compensate for uneven force being applied in use, by a patient to one lever as applied to the other lever. Any suitable coupling mechanism may be employed. In one embodiment, the two opposing levers are provided with meshing teeth, which teeth are arranged to mesh together thereby providing a coupling action.
The use of a lower end pivoted lever configuration has the advantage that a long lever can be used thereby maximising the mechanical ratio between the input force and the force applied to actuate the transfer element. In addition the use of a lever pivotally supported at its lower end is ergonomically more efficient than using a lever pivotally supported at an upper end due to the fact that a user will normally grasp the dispenser device with their thumb positioned close to the end of the lever. With a lever pivotally supported at an upper end (again, relative to the normal ‘in use’ configuration) the location of a patient's thumb is close to the position about which the lever pivots and hence the maximum leverage is not obtained.
Optionally, there is provided to the drug dispenser device a locking mechanism for reversibly locking/unlocking the movement of the at least one finger operable member and/or the container collar. The purpose of the locking mechanism is to prevent unintended movement of the at least one finger operable member and/or container collar and hence, to prevent unintended actuation of the dispenser device.
In one embodiment, the locking mechanism is provided to a removeable cover for the outlet (e.g. mouthpiece or nozzle cover). Thus, in use the patient would remove the outlet cover thereby simultaneously revealing the outlet and unlocking the locking mechanism. Conversely, after the use the outlet cover is replaced to again lock the at least one finger operable member and/or container collar. In alternative embodiments, the locking mechanism may comprise an integral part of the removeable cover or by provided as a fixed add-on thereto or be provided as a moveable (e.g. rotatable or translatable) add-on thereto.
In one embodiment, the locking mechanism is arranged to prevent unintended movement of the container collar and hence, firing of the discharge mechanism, but does not impede the movement of the at least one finger operable member and/or of the transfer element. Thus, when the container collar is in its locked state (i.e. locking mechanism is performing its locking function) the at least one finger operable member (e.g. levers) may still be moved and that movement transfer energy via the biasing mechanism to move the transfer element, but all movement of the container collar is prevented. This form of locking arrangement has the advantage that unintended force applied to the finger-operable (e.g. levers) allows for travel thereof without damage thereto or to the device as a whole, but without any actuation of the dispenser device (e.g. by firing of the discharge mechanism).
In one embodiment, the container collar is provided at its underside with one or more (e.g. two) downward protrusions and the mouthpiece is provided with a locking mechanism in the form of one or more interference elements. In embodiments, the interference element(s) is P-shaped and joined to the mouthpiece by means of a suitable hinge (e.g. living hinge) about which the interference element(s) may rotate. In an embodiment, there are two interference elements joined together by a bridge element. When, the mouthpiece engages with the body of the dispenser device (i.e. in the mouthpiece-closed position) the interference element(s) abuts the downward protrusion(s) to thereby prevent (i.e. lock) any downward movement of the container collar. Unintended movement of the container collar and hence, unintended actuation of the dispenser device (i.e. firing of the discharge mechanism) is hence prevented. In embodiments, however the at least one finger operable member and transfer element are free to move, even when the container collar is in its locked state.
One particular locking mechanism, in which one or more rotatable interference elements are provided to the mouthpiece, is described in Applicant's co-pending PCT Patent Application No. WO-A-2007/028992 which claims priority from UK patent application no. 0518355, each incorporated herein by reference.
There is further provided (e.g. to the container collar) a pre-load mechanism to prevent transfer of actuation force from the transfer element to the container collar to (i) move said discharge device along the longitudinal axis in the first direction to actuate the discharge mechanism, and optionally also (ii) to actuate any actuation counter until a pre-determined threshold force is overcome.
Thus, initially as the transfer element is provided with actuation force in the direction of the longitudinal axis in response to patient actuation of the at least one finger operable member the pre-determined threshold force is experienced. Once however, the pre-determined threshold force as defined by the pre-load mechanism is exceeded, the actuation force is released and the transfer element is thereby, propelled along the longitudinal axis in the first direction in driving relationship with the container collar to drive the container collar (and hence the discharge device) in the first direction to actuate the discharge mechanism resulting in discharge of drug formulation through the discharge channel and to the outlet for delivery to the patient.
In other words, the pre-load mechanism acts such as to prevent actuation of the discharge mechanism of the drug discharge device until a pre-determined threshold force is applied to the at least one finger operable member. The pre-determined threshold force might thus, be thought of as a ‘barrier’ force which must first be overcome before the actuation force may be released to actuate the discharge mechanism. In essence, the pre-load mechanism acts as a ‘commitment’ feature, which allows release of actuating force/energy to the dispensing mechanism only when the ‘barrier’ force has been exceeded.
Typically, the pre-determined threshold force is in the range from 5 to 40N, more typically from 10 to 30N (e.g. 15N). That is to say, typically from 5 to 40N, more typically from 10 to 30N (e.g. 15N) of force must be applied by the patient to overcome the pre-determined threshold before actuation of the discharge mechanism is enabled. Such values tend to correspond to a force which prevents a suitable ‘barrier force’ to a weak, nondescript or unintended finger movement whilst readily being overcome by the determined finger (or thumb) action of a user. It will be appreciated that if the device is designed for use by a child or elderly patient it may have a lower pre-determined force than that designed for adult usage.
Preferably, each detent comprises a flexible (e.g. resilient) support limb, such as a support leg which engages (e.g. latches to) a step or abutment provided to the housing. When the pre-determined threshold force is overcome, the or each flexible support limb disengages from the step or abutment to allow the container collar to move along the longitudinal axis such that the discharge mechanism is actuated. In embodiments, the or each support limb is provided to the lower end of the container collar (i.e. that end which is closest to the outlet). An arrangement of from two to four (e.g. three) flexible support limbs is particularly preferred. Alternatively, the or each support limb may have a hinged or articulated form.
For effective actuation of the discharge mechanism (e.g. valve or pump) of the drug discharge device the actuating force must be sufficient to both overcome the pre-determined force of the pre-load mechanism and to actuate that discharge mechanism. Thus, for example where the discharge mechanism comprises a valve or pump having a return spring, the actuating force should be sufficient to overcome that return spring to reliably fire the valve or pump.
It is desirable that the actuating force, which is applied by the patient to the at least one finger operable member be kept to a minimum. Desirably also, the overall size of the device is kept relatively small (e.g. fits comfortably in the patient's hand) from both an ergonomics and aesthetics standpoint.
There is further provided a biasing return mechanism, which connects the container collar to the transfer element. The biasing return mechanism acts to store biasing return energy on moving the transfer element relative to the container collar along the longitudinal axis in the first direction, and in the absence of actuating force acts such as to move (‘reset’) the transfer element back to its initial position relative to the container collar.
In embodiments, the biasing return mechanism comprises one or more springs (e.g. extension springs) or other resiliently compressible or expandable mechanical members for storing mechanical energy. Preferably, the biasing mechanism comprises an arrangement of two springs locating one on either side of the container collar (i.e. at a 180° radial spacing).
The drug dispenser herein optionally includes an actuation counter. The actuation counter suitably includes a mechanism for registering and displaying dose count information to the patient. Suitably, that dose count information relates to the number of doses of drug delivered from or remaining in the dispenser device. The information may be delayed in digital or analogue form, typically using standard count indicia (e.g. ‘999’ to ‘000’ indicia count display). Embodiments involving either ‘counting up’ or ‘counting down’ in increments are envisaged.
The pre-load mechanism herein acts such as to prevent transfer of actuating force to the container collar to actuate the actuation counter until a pre-determined threshold force is overcome. Thus, a count is registered by the actuation counter only in response to a user actuation that is sufficient to overcome the ‘barrier’ force provided by the pre-load mechanism and which thereby results in dispensing of a dose from the drug container.
The actuation counter may adopt any suitable form. The actuation counter is in embodiments sized and shaped for effective receipt by the housing of the drug dispenser.
In embodiments, the actuation counter is supplied as an assembly for insertion into the drug dispenser.
In embodiments, an inner wall of the housing of the drug dispenser acts as a mounting for some or all of the parts of the actuation counter.
In embodiments, the actuation counter comprises one or more count wheels provided with count indicia thereon for display of the actuation count.
In an embodiment, the actuation counter comprises:
a first count wheel arranged to rotate about a first axis of rotation, said first count wheel including one or more drive receipt elements arranged thereon for receipt of drive for drivable rotation of the first count wheel about said first axis of rotation;
In embodiments, the preferred actuation counter is configured and arranged so that said intermittent meshing is able to occur a plurality of times.
The first or second count wheel may for example, take the form of a disc or a ring.
The drive receipt elements can take any suitable form including one or more teeth and/or indents. In embodiments, the drive receipt elements of the first count wheel are arranged annularly, such as about an inner or outer circumferential wall of the first count wheel.
In one embodiment, the one or more drive receipt elements of the first count wheel comprise a set of teeth arranged annularly thereon for drivable rotation of the first count wheel about the first axis of rotation. Drive of the teeth is in embodiments provided by a driver element provided to another part of the drug dispenser. In embodiments, the driver element is provided to the container collar or container or to a drive feature connecting to the container collar or container.
In another embodiment, the preferred actuation counter is provided with a ratchet, and the one or more drive receipt elements of the first count wheel comprise one or more ratchet drive receipt elements arranged thereon for receipt of drive from said ratchet to rotate the first count wheel about said first axis of rotation.
The ratchet is in embodiments a ratchet wheel arranged for rotation about an axis, which is preferably common with the first axis of rotation about which the first count wheel rotates. The ratchet is in embodiments provided with one or more ratchet drive elements such as one or more ratchet drive tongues.
In embodiments, the ratchet is itself provided with one or more drive receipt elements for receipt of drive that results in movement (e.g. rotation) of the ratchet. Such drive receipt elements can take any form including one or more teeth, protrusions and/or indents. Drive of the drive receipt elements of the ratchet is in embodiments provided by a driver element provided to another part of the drug dispenser. In embodiments, the driver element is provided to the container collar or container or to a drive feature connecting to the container collar or container.
In a preferred embodiment, the first count wheel is provided with a circular cavity (e.g. hollowed out portion) sized and shaped for receipt of the ratchet wheel. The ratchet drive receipt elements are arranged about the inner circumferential wall (i.e. about the periphery) of the cavity for suitable ratchet drive interaction with the ratchet wheel.
Alternatively, the first count wheel takes the form of a ring that is sized and shaped for disposed receipt of the ratchet wheel. The ratchet drive receipt elements are arranged circumferentially about (i.e. about the periphery of) the inner wall of the ring for suitable ratchet drive interaction with the ratchet wheel.
In embodiments, the first and second wheels may be arranged to rotate in the same direction or in opposing directions (i.e. one clockwise and one anti-clockwise).
In embodiments, the second count wheel is arranged concentric to the first count wheel. In one embodiment, the second count wheel takes the form of a ring and the first count wheel (e.g. disc or ring shape) is sized and shaped for receipt within the ring. The diameter of the first count wheel is therefore typically slightly less than that of the inner diameter (i.e. the ring hole diameter) defined by the ring-shaped second count wheel.
In one embodiment, the first and second count wheels are arranged concentrically and at the same level (i.e. they share the same plane of rotation).
In another embodiment, the first and second count wheels are arranged concentrically and at different levels (i.e. with different planes of rotation).
In embodiments, the plane of rotation of the second counter wheel is slightly raised relative to that of the first counter wheel. In one embodiment, the second count wheel is provided with a protrusion that in use, extends over and above part of the first count wheel and that may therefore function to shutter off part of the first count wheel.
The kick teeth are preferably arranged in annular fashion at or about the circumference of the kick wheel.
As the kick wheel is rotated the meshing of the kick teeth thereof with the teeth of the second count wheel results in rotation of the second count wheel.
The first count wheel further includes at least one fixed index tooth arranged for intermittent meshing with the kick teeth of the kick wheel. That is to say, the at least one index tooth is fixed to the first count wheel and may be brought into meshed relationship with the kick teeth of the kick wheel on an intermittent basis.
Rotary motion of the kick wheel results from rotary motion of the first count wheel only when said intermittent meshing of the at least one index tooth with the kick teeth occurs. When meshing occurs, a contact ratio of 1 between the at least one index tooth and the kick teeth is preferred, although other whole integer (2, 3 . . . ) contact ratios may be used.
Typically, the at least one index tooth is fixed at a point at or about the circumference of the first count wheel. Rotation of the first count wheel is then arranged to bring the at least one index tooth into meshed relationship with the kick teeth of the kick wheel at a particular point of the rotary cycle of the first count wheel. It may be therefore be appreciated that in this case, meshing occurs once during each complete rotation of the first count wheel.
In embodiments, either one or both counter wheels interact with a reverse rotation (e.g. ratchet) mechanism to prevent reverse movement of the counter wheels.
In embodiments, some or all gear teeth of some or all of the toothed parts herein have flanged form to enable effective meshing together thereof.
In embodiments, the actuation counter includes a counter housing, which houses some or all of the other elements of the actuation counter. In embodiments, the counter housing is defined at least in part by the housing of the drug dispenser.
In embodiments, the counter housing is shaped to define the first axis of rotation and the second axis of rotation. In embodiments, the first count wheel mounts to the counter housing for rotation about the first axis of rotation and the kick wheel mounts to the counter housing for rotation about the second axis of rotation.
In embodiments, the counter housing includes a viewing window through which the count may be viewed. In embodiments, the counter housing includes a bezel and/or lens cover for the count wheels and through which indicia of the count wheels are generally visible.
In one embodiment, a shutter is provided to close off the viewing window at a predetermined point in the actuation counter operation, particularly at the ‘end of life’ of the drug product, which typically corresponds to the point at which all doses in the normal (prescribed) delivery cycle have been provided. In embodiments, the shutter may be provided as a separate element of the actuation counter or drug dispenser or be formed as an integral part of the second counter wheel, as described hereinbefore.
In embodiments, the first and second count wheels are adapted in use to rotate in the same sense about the first axis.
In embodiments, the drug dispenser has a display region through which the first and second count wheels are rotatable and a shutter which is movable to a shuttering position in which it shutters the display region. In embodiments, the actuation counter is so configured and arranged that the shutter is only movable to the shuttering position when the first and second count wheels are in predetermined angular positions about the first axis. In embodiments, the actuation counter is configured and arranged so that the shutter is only able to be moved to the shuttering position when the first count wheel has rotated through a plurality of revolutions about the first axis. In embodiments, the actuation counter is configured and arranged such that the shutter moves to its shuttering position in response to movement of at least one of the count wheels.
In embodiments, the shutter is moved to its shuttering position by the at least one count wheel. In embodiments the shutter is carried to the shuttering position by the at least one count wheel. In embodiments, the at least one count wheel is the second count wheel. In embodiments, the at least one count wheel and the shutter have cooperating parts through which, in use, the at least one count wheel moves the shutter to its shuttering position.
In embodiments, the actuation counter is configured and arranged to display a count sequence with the count wheels and to cause the shutter to move to its shuttering position at the end of the count sequence.
In embodiments, the shutter is comprised in one of the count wheels. In embodiments, the count wheel is integrally formed with the shutter. In embodiments, the shutter overlies the other count wheel. In embodiments, the shutter is comprised in the second count wheel.
In embodiments, the actuation counter is configured and arranged to sequence from a count mode of operation, in which the first count wheel is able to drive rotation of the second count wheel through the kick wheel, to a non-count mode of operation, in which the first count wheel is unable to drive rotation of the second count wheel through the kick wheel. In embodiments, the actuation counter is arranged to sequence from the count mode to the non-count mode when the first count wheel has completed a predetermined number of revolutions about the first axis. In embodiments, the actuation counter is adapted to sequence from the count mode to the non-count mode when the second count wheel is disposed in a predetermined angular orientation about the first axis.
In embodiments, the actuation counter is configured and arranged such that in the non-count mode meshing of the kick teeth with the at least one index tooth and/or the second count wheel teeth is unable to occur. In embodiments, a gap is provided in the set of kick teeth or the second count wheel teeth to disable meshing in the non-count mode.
In an embodiment of the invention, the actuation counter is a dose counter for counting the number of doses of drug dispensed from the drug dispenser device and comprises first and second count wheels which are concentrically arranged for rotation on a common axis of rotation, each count wheel having count indicia thereon; a display region positioned for the count indicia of each count wheel to register with and display the count of the counter; a ratchet for incrementally rotating the first count wheel in a predetermined sense to change the count indicia thereof registering with the display region; and a mechanism adapted to intermittently transmit the incremental rotation of the first count wheel into an incremental rotation of the second count wheel in a predetermined sense to change the count indicia thereof registering with the display region.
According to another aspect of the present invention there is therefore provided a housing assembly according to claim 128.
According to a still further aspect of the present invention there is provided a kit of parts comprising a housing assembly as described above and a drug discharge device receivable thereby. The drug discharge device has a longitudinal axis and comprises a container for storing a drug formulation to be dispensed, a discharge mechanism and a discharge channel extending from said container for discharge of said drug formulation.
In a yet further aspect of the invention there is provided a drug dispenser device according to claim 45.
The drug dispenser device comprises a housing which comprises an outlet for insertion into a body cavity of a patient.
The drug discharge device may be disposed in the housing such that the discharge mechanism is held stationary and the container is movable in a first direction relative to the discharge mechanism to put the device in a discharge mode where the formulation is discharged from the container to the outlet.
There is provided a transfer (or loading) arrangement for transferring the container in the first direction relative to the discharge mechanism comprising a first part attached to the container, a second part connected to the first part so that the first and second parts are movable towards and away from each other, a return biasing force mechanism for biasing the first and second parts to a resting configuration thereof, a latch adapted in use to latch the first part against movement in the first direction, and a latch release adapted for releasing the latch, when an actuating force of greater than a pre-determined threshold force is applied to the second part in the first direction, to enable the actuating force to move the first part in the first direction and carry the container in the first direction relative to the discharge mechanism to put the drug discharge device in its discharge mode.
An actuation counter is optionally configured and arranged to be actuated by movement of the first part or the container in the first direction on release of the latch.
The latch may be provided on the first part and the latch release may be provided on the second part. The first part may be a collar. The second part may be a collar, for instance of annular form. The latch may be formed by one or more projections of the first part. The latch release may be formed by a surface thereof for contacting the latch for release thereof. The return biasing force may be provided by a resilient element, typically a spring. The device may have an actuating mechanism for moving the second part of the transfer (loading) arrangement in the first direction the predetermined distance from the first part for the latch release to release the latch. The actuating mechanism may comprise at least one finger operable member, for instance one or more levers, such as in the embodiments hereinafter to be described with reference to the drawings.
According to a further aspect of the invention there is provided a loading arrangement for loading a fluid dispensing container into a dispensing mode thereof, comprising:
a first part for attachment to the container;
a second part movable in a first direction;
a latch adapted in use to latch the first part against movement in the first direction; and
a latch release adapted for releasing the latch, when the second part has moved a predetermined distance from the first part in the first direction,
wherein the first and second parts are provided with co-operable drive features adapted in use to engage after the latch is released so that the second part is able to drive the first part in the first direction for placing the fluid dispensing container into its dispensing mode.
In an embodiment of the invention, such as in the illustrated embodiments, the second part may only be able to move the predetermined distance from the first part upon application of a predetermined force thereto. The application of the predetermined force causes the second part to continue to move in the first direction after release of the latch so as to drive the first part in the same direction through the drive features.
The second part may be connected to the first part, for example through a biasing mechanism (e.g. one or more biasing elements, such as springs).
An actuation counter may be configured and arranged to be actuated by movement of the first part or the container in the first direction on release of the latch.
The latch may be provided on the first part and the latch release may be provided on the second part. The predetermined force may thus be the force required to be applied for the latch to be released. The first part may be a collar. The second part may be a collar, for instance of annular form. The latch may be formed by one or more projections of the first part. The latch release may be formed by a surface of the second part for contacting the latch for release thereof.
The fluid dispensing container may comprise a container part for a fluid, suitably a fluid drug formulation, and to which the first part is attached, and a dispensing member through which fluid inside the container part is dispensible therefrom on movement of the container part relative to the dispensing member (the “dispensing mode”). The dispensing member may be a valve stem of a valve or a pump stem of a pump. In use, when the latch release releases the latch, the first part (driven by the second part) is able to move the container part relative to the dispensing member when this is held stationary, e.g. in a support therefor in a drug dispenser, such as a stem/nozzle block in a metered dose inhaler (MDI) actuator.
In another aspect of the invention there is provided an assembly of a fluid dispensing container and the loading arrangement of the invention, the first part being attached to the container.
In a yet further aspect of the invention there is provided a drug dispenser having a housing which receives the assembly of the invention, the container comprising the container part and the dispensing member, the housing having a support which receives the dispensing member and a latching surface for the latch to latch to to latch the first part, and hence the container part, against movement in the first direction, and the dispenser having an outlet through which fluid dispensed from the container part is dispensible from the dispenser and an actuating mechanism for moving the second part of the loading arrangement in the first direction the predetermined distance from the first part for the latch release to release the latch from the latching surface and for the second part to drive the first part in the first direction and consequently move the container part in the first direction relative to the dispensing member for dispensing therefrom through the outlet.
The actuating mechanism may comprise at least one finger operable member, for instance one or more levers, such as in the embodiments hereinafter to be described with reference to the drawings.
FIG. 1 shows a perspective view of a hand-held, hand-operable, breath coordinated drug dispenser device of the MDI type herein in the ‘at rest’ position;
FIG. 2 shows a perspective view of the drug dispenser device of FIG. 1 with upper front cover part, front plate, mouthpiece and mouthpiece cover removed and the lower front cover part shown in cut-away section, the device again being shown in the ‘at rest’ position;
FIGS. 3 a to 3 b show front views of the drug dispenser device of FIG. 1 with upper front cover part and front plate removed and the left lower front cover part and left-side of mouthpiece shown in cut-away section, the device respectively being shown in ‘at rest’ and second stage of actuation positions;
FIGS. 4 a to 4 c show front views of the drug dispenser device of FIG. 1 with upper front cover part, front plate and left lever removed and the left lower front cover part and left-side of mouthpiece shown in cut-away section, the device respectively being shown in third, fourth and fifth stages of actuation positions;
FIG. 5 shows an exploded view of part of the internal mechanism of the drug dispenser device of FIG. 1;
FIGS. 6 a to 6 e show sectional side views of interaction of the container collar and extension collar parts of the dispenser device of FIG. 1 during sequential operational steps of the internal mechanism as shown in FIG. 5;
FIG. 7 shows a schematic scrap view of the drug dispenser device of FIG. 1 to reveal part of the internal mechanism and in particular, the ‘interlock’ mechanism provided to block actuation thereof when the mouthpiece is covered by the mouthpiece cover;
FIG. 8 shows a perspective view of the drug dispenser device of FIG. 1 with the mouthpiece cover removed from the mouthpiece and thus, in a ‘ready to use’ position;
FIG. 9 shows a perspective view of the drug dispenser device of FIG. 1 with the mouthpiece cover removed from the mouthpiece and the levers depressed and thus in the ‘in use’ position;
FIG. 10 illustrates a perspective view of a first half of the drug dispenser of FIG. 1 showing air flow into the housing in the ‘in use’ position thereof;
FIG. 11 illustrates a perspective cut-away view of a second half of the drug dispenser device of FIG. 1 (with actuation counter and details of internal mechanism omitted) showing air flow through the chambers of the housing in the ‘in use’ position thereof;
FIG. 12 illustrates a perspective cut-away view of a second half of a drug dispenser device that is a slight variation of that drug dispenser device of FIG. 1 (with actuation counter and details of internal mechanism omitted) showing air flow through the inhaler body in the ‘in use’ position thereof;
FIG. 13 shows an exploded view of an actuation counter herein arranged for receipt within the front upper housing part of the first drug dispenser of FIG. 1 or second drug dispenser device of FIG. 12;
FIGS. 14 a and 14 b respectively show underside and top views of the actuation counter of FIG. 13;
FIGS. 15 a and 15 b show cut-away views of the actuation counter of FIG. 13 at respectively ‘count 120’ and ‘count 119’ positions;
FIGS. 16 a and 16 b respectively show cut-away views corresponding to FIGS. 15 a and 15 b of the actuation counter of FIG. 13 absent the decimals count wheel;
FIGS. 17 a and 17 b respectively show cut-away views corresponding to FIGS. 15 a and 15 b of the actuation counter of FIG. 13 absent the numerals count wheel;
FIGS. 18 a and 18 b show cut-away views of the actuation counter of FIG. 13 at respectively ‘count—0’ and ‘shuttered’ positions;
FIGS. 19 a and 19 b respectively show cut-away views corresponding to FIGS. 18 a and 18 b of the actuation counter of FIG. 13 absent the numerals count wheel;
FIG. 20 shows a front view of the drug dispenser device of FIG. 1 with upper front cover part and actuation counter removed, the device being in the ‘at rest’ position;
FIG. 21 shows a perspective view of the drug dispenser device of FIG. 1 with the upper front cover part and actuation counter disposed therein shown detached from the remainder of the device, the device being shown in a ‘at rest’ position;
FIG. 22 shows a plan view of the inner side of the upper front cover part of the drug dispenser device of FIG. 1 and showing the actuation counter disposed therein;
FIG. 23 shows a perspective view from above of the lower housing part and mouthpiece assembly (shown separated) of the drug dispenser device of FIG. 1;
FIGS. 24 a and 24 b show an alternative ‘two part form’ lower housing part, as respectively shown separated and as assembled, for use with the drug dispenser device of FIG. 1;
FIGS. 25 a to 25 n respectively show front views of mouthpiece forms, which may be employed in the drug dispenser devices of FIG. 1 or 12 as an alternative to the mouthpieces thereof.
A ledge 13 a, 13 b is provided to the base of the lower housing part 12 such that the device may be arranged to ‘stand upright’ on the ledges 13 a, 13 b and mouthpiece cover 16, when cover 16 covers the mouthpiece 14. When the cover 16 is moved to its ‘mouthpiece uncovered’ position, the device is able to ‘stand upright’ on the end face 16 a of the cover 16 itself (see FIG. 8).
A viewing window 216 is provided to the front upper housing part 10 a for viewing of count indicia displayed by a counter 201 locating within that part 10 a and described in more detail hereinafter with reference to FIGS. 13 to 22.
FIG. 23 shows the lower housing part 12 and mouthpiece 14 (shown separated from each other, in this view) of the drug dispenser device of FIG. 1. Provided to the lower housing part 12 is stem block 8, which is arranged to receive valve stem 7 of an aerosol canister 5 (see also FIGS. 3 a and 5). The stem block 8 also includes a passage 9, which in use acts such as to guide discharged aerosolized drug from the valve stem 7 to the mouthpiece 14. Step portions 18 a, 18 b, 18 c, the purpose of which will be described in more detail in the later description, are also provided.
FIGS. 24 a and 24 b show an alternative ‘two part form’ lower housing part 412, as respectively shown separated and as assembled, for use with the drug dispenser device of FIG. 1 as an alternative to the lower housing part 12 of FIG. 23. This two part form comprises lower housing part 412, which is arranged to receive separate stem block part 490. That separate stem block part 490 includes stem block 408 and stem block passage 409. As before, the lower housing part defines step portions 418 a, 418 b, 418 c. During assembly the separate parts 412, 490 are brought together and sockets 494 a, 494 b, 494 c on the stem block part 490 aligned with posts 492 a, 492 b, 492 c on the lower housing part. The parts 412, 490 are then joined to each other by means of heat welding (‘heat staking’) at each respective post 492 a, 492 b, 492 c to socket 494 a, 494 b, 494 c mating point. Advantages of using the alternative ‘two part form’ lower housing part 412 and stem block part 490 assembly are that the precision features of the stem block part 490 are easier to produce and inspect. The stem block part 490 is generally made from a polymer selected for ease of drug delivery. The lower housing part 412 is in embodiments, formed of ABS.
Details of the inner workings of the device 1 of FIG. 1 may be appreciated by reference to FIG. 2, in which the upper 10 a front housing part and mouthpiece cover 16 have been removed. It will be seen that each opposing lever 20 a, 20 b pivotally connects to the upper housing part 10 a, 10 b by means of pivot connector 22 a, 22 b. The positioning of the pivotal connection is selected to facilitate the desired finger-thumb operability of the levers 20 a, 20 b by a squeezing movement. It will also be seen that the lower ends 21 a, 21 b of each lever 20 a, 20 b are geared such as to mesh together, thereby tending to the couple the motion of each respective lever 20 a, 20 b one to the other.
Provided to the housing, but partially obscured from view by container collar 30, there is provided a drug discharge device, which takes the form of cylindrical valved aerosol canister 5 of the type commonly known for use in an MDI. The valve stem 7 of the drug discharge device (see also FIGS. 3 a, 3 b and 5) is received within the stem block 8 provided to the housing, which stem block 8 includes the passage 9 which acts such as to guide discharged aerosolized drug from the valve stem to the mouthpiece 14.
In this embodiment, and particularly referring to FIG. 5, the canister 5 has a body 6 made of metal, for instance of stainless steel or, more preferably, of aluminium or an aluminium alloy. The canister contains a pressurised drug aerosol formulation. The formulation comprises the drug (one or more drug actives) and a fluid propellant, and optionally one or more excipients and/or adjuvants. The drug is in solution or suspension in the formulation. The propellant is typically a CFC-free propellant, suitably a liquid propellant, and preferably is a HFA propellant, such as HFA-134a or HFA-227 or a combination thereof. The drug active(s) is typically of the type for use in treatment of a respiratory disease or condition, such as asthma or chronic obstructive pulmonary disease (COPD). The active(s) may also be for prophylaxis or palliation of a respiratory disease or condition.
The valve stem 7 forms part of a metering valve (not shown) mounted in the canister 5, as will be understood by the skilled person in the art, and as commercially available from manufacturers well known in the aerosol industry, for example, from Valois, France (e.g. DF10, DF30, DF60), Bespak plc, UK (e.g. BK300, BK356, BK357) and 3M-Neotechnic Ltd, UK (e.g. Spraymiser™). The metering chamber of the metering valve may be coated with a fluorinated polymer coating, such as formed from perfluoro-hexane, for instance by cold plasma polymerisation, as detailed in US-A-2003/0101993.
As may be further understood with reference also to FIG. 5, which shows an exploded view of key parts of the internal mechanism, the container collar 30 permanently engages via split-ring collar 33 with the neck 5 a of the canister 5 such that the so-engaged parts are moveable together relative to the housing in a direction defined by the longitudinal axis L-L of the canister 5 (i.e. generally up and down when the device 1 is upright). The split-ring collar 33 permanently engages the container collar 30 to the canister 5 as described in U.S. patent application Ser. No. 10/110,611 (WO-A-01/28887) and US-A-2006/0082039.
With reference now also to FIGS. 6 a to 6 e, the container collar 30 connects via closed coil extension return springs 50 a, 50 b and respective spring connection points 31 a, 31 b and 41 a, 41 b to extension collar 40, which is provided at its lower end with outer ramps 44 a, 44 b, and also with inner ramps 43 a, 43 b. This multi-collar arrangement is such that the extension collar 40 is moveable with respect to the container collar 30 along the longitudinal axis L-L of the drug discharge device.
The extension collar 40 includes an actuating portion in the form of shelf 42, which is arranged for interaction with the lower ends 21 a, 21 b of the opposing levers 20 a, 20 b such that when the levers are squeezed together (i.e. inwards relative to the housing) the shelf 42 and hence, extension collar 40 are pushed downwards. The container collar 30 is further provided with flexible support legs 34 a, 34 b, which act to provide a pre-load mechanism to prevent transfer of the actuating force to the container collar 30 to move the canister 5 downwards along the longitudinal axis L-L to actuate the valve thereof (and hence, to fire the aerosolized drug dose) until a pre-determined threshold force is overcome. Each flexible support leg 34 a, 34 b is arranged for interaction with a respective step 18 a, 18 b on the housing. Each flexible support leg 34 a, 34 b is also provided with a protruding inner foot 35 a, 35 b and protruding outer foot 36 a, 36 b, the purpose of which will become clearer from the later description.
In the ‘at rest’ position of FIGS. 2, 3 a and 6 a, the bottom of each flexible support leg 34 a, 34 b is slightly spaced from its respective step 18 a, 18 b on the housing. The container collar 30 is further provided with downward protrusions 38 a, 38 b, the purpose of which will also become clear from the later description. In embodiments, a third flexible support leg (not visible, but associated with third step 18 c as visible on FIG. 23) locates at the rear of the container collar.
In general operational terms, referring now also to FIG. 3 a, the opposing levers 20 a, 20 b are moveable inwardly, transversely with respect to the longitudinal axis H-H of the housing, to apply an actuating force to the shelf 42 of the extension collar 40 to move the extension collar 40 downwards along that longitudinal axis (i.e. towards stem block 8 and mouthpiece 14).
The flexible support legs 34 a, 34 b act to provide a pre-load mechanism to prevent transfer of that actuating force to the container collar 30 to move the canister 5 downwards along the longitudinal axis L-L of the drug discharge device (see FIG. 5), which is coincident with longitudinal axis H-H of the housing, to actuate the valve thereof (and hence, to fire the aerosolized drug dose) until a pre-determined threshold force is overcome.
Further details of the operation of the device 1 (which results from an effective user actuation thereof) may be appreciated by making reference to FIGS. 3 a to 4 c, and FIGS. 6 a to 6 e, in which for clarity only selected parts relevant to the particular stage of operation represented are labelled.
FIG. 3 a shows how the device 1 is configured in the ‘at rest’ position, in this instance also with the mouthpiece 14 covered by the mouthpiece cover 16. FIG. 6 a shows in greater detail the relationship between the flexible legs 34 a, 34 b of the container collar 30 and the extension collar 40 in this ‘at rest’ position. The levers 20 a, 20 b are splayed apart and catch retainers 24 a, 24 b provided to an inner part of the protruding end 23 a, 23 b of each respective lever 20 a, 20 b locate close to ‘stop’ positions defined by notches 15 a, 15 b provided to the top parts 10 a, 10 b of the housing. The lower ends 21 a, 21 b of each lever 20 a, 20 b seat against the shelf 42 of the extension collar 40, but in this ‘at rest’ position no force acts on the extension collar 40. The closed coil return springs 50 a, 50 b are therefore also in their ‘at rest’ state with no significant biasing return energy stored therein. Typically, in the ‘at rest’ state the springs 50 a, 50 b will carry a small amount of pre-load (e.g. 1-3N, such as 2N) which is present in order to negate any free movement between the container collar 30 and the extension collar 40 due to tolerance variation. Each end of the flexible support legs 34 a, 34 b is slightly spaced from its respective step 18 a, 18 b on the housing. This ensures the valve is closed in the ‘at rest’ position of the device 1.
In FIG. 6 b, the device is at a first early stage of operation, corresponding to a position after removal of the mouthpiece cover 16 from the mouthpiece 14, in which the levers 20 a, 20 b will have been squeezed very slightly together. The lower ends 21 a, 21 b of each lever 20 a, 20 b will have pushed slightly down on the shelf 42 of the extension collar 40 such that the extension collar 40 is moved slightly downwards relative to the container collar 30. Importantly, as shown in FIG. 6 b, this downwards movement of the extension collar 40 brings each outer ramp 44 a, 44 b into engagement with each outer protruding foot 36 a, 36 b of the flexible support legs 34 a, 34 b. As a result of this engagement, further downwards movement of the extension collar 30 will cause downwards force to be transferred to the flexible support legs 34 a, 34 b of the container collar 30. Moreover, the downward movement of the extension collar 40 relative to the container collar 30 moves the inner ramps 43 a, 43 b to a position relative to the flexible support legs 34 a, 34 b which enables the legs 34 a, 34 b to buckle when the commit force is achieved, as to be described shortly hereinafter.
In FIGS. 3 b and 6 c, the device is at a second early stage of operation, in which the levers 20 a, 20 b have been squeezed slightly more together. The lower ends 21 a, 21 b of each lever 20 a, 20 b push slightly down on the shelf 42 of the extension collar 40 such that the extension collar 40 is moved slightly more downwards. This further downwards movement of the extension collar 40 brings each bottom end of the flexible support legs 34 a, 34 b into latching engagement with its respective step 18 a, 18 b on the housing through the driving engagement of the outer ramps 44 a, 44 b with the outer protruding feet 36 a, 36 b. As a result of this latching engagement, further downwards movement of the container collar 30 is impeded, with the user (patient) experiencing increasing lever force as they continue to depress the levers 20 a, 20 b.
In FIG. 4 a, the device is at a third stage of operation, in which the levers 20 a, 20 b have been squeezed even further together. The lower ends 21 a, 21 b of each lever 20 a, 20 b push further down on the shelf 42 of the extension collar 40 such that the extension collar 40 receives downwards force. That downwards force cannot however, be transmitted to the container collar 30 because of the latching engagement of each bottom end of the flexible support legs 34 a, 34 b with its respective step 18 a, 18 b on the housing. That latching engagement thus, impedes the downwards movement of the container collar 30.
In FIGS. 4 b and 6 d, the device is shown at a fourth stage of operation, in which the levers 20 a, 20 b have been squeezed even further together. The lower ends 21 a, 21 b of each lever 20 a, 20 b push even further down on the shelf 42 of the extension collar 40 such that the extension collar 40 receives further downwards force. Each outer ramp 44 a, 44 b of the extension collar 40 is brought even further down on each protruding outer foot 36 a, 36 b of each flexible leg support 34 a, 34 b thereby causing each flexible leg support 34 a, 34 b to flex inwards and to be displaced interiorly relative to the housing. Thus, FIGS. 4 b and 6 d correspond to the position at which the pre-load threshold force (typically about 16N) provided by the latching engagement of the flexible legs 34 a, 34 b with their respective steps 18 a, 18 b on the housing is just about to be overcome by the actuating force provided by the levers 20 a, 20 b to the extension collar 40. This position therefore corresponds to the threshold (or ‘tipping point’) of the pre-load system defined by the components of the device. Applying any further squeeze force to the levers 20 a, 20 b will result in that threshold being exceeded and effective user actuation of the device 1.
In FIGS. 4 c and 6 e, which corresponds to a fifth stage of operation, such further force has been applied to the levers 20 a, 20 b. The protruding end 21 a, 21 b (see also FIG. 3 a) of each respective lever 20 a, 20 b touches off one against the other, thereby preventing any further lever 20 a, 20 b travel. Most importantly, the flexible legs 34 a, 34 b have flexed and become displaced from their respective steps 18 a, 18 b through the action of the downward movement of the outer ramps 44 a, 44 b. The extension collar 40 now moves instantaneuously downwards, relative to the container collar 30, as a result of its experience of the unrestricted actuating force resulting in the the extension collar 40 drivably engaging the stop features 37 a, 37 b provided to container collar 30 to thereby drive the container collar 30 (and hence canister 5 in permanent engagement therewith) rapidly downwards. The valve of the canister 5 is thereby activated to release aerosolized drug through the passage 9 in the stem block 8 which guides that discharged aerosolized drug to the mouthpiece 14 for inhalation by the patient.
The threshold force to be overcome for releasing (disengaging) the legs 34 a, 34 b from the steps 18 a, 18 b should be great enough to ensure instantaneous acceleration of the extension collar 40 when the legs 34 a, 34 b are released (disengaged). This will then make the firing of the device (release of a metered drug dose by the valve) user-independent since the user cannot affect the firing mechanism performance once the threshold (commitment) force is overcome. As a result, reliable dosing from the device is provided for.
Following actuation, the return springs 50 a, 50 b act such as to provide return biasing energy to move the extension collar 40 and levers 20 a, 20 b back to the ‘at rest’ position as shown in FIGS. 2, 3 a and 6 a. In turn, the canister 5 and container collar 30 are moved back to their ‘at rest’ position under the action of the internal valve spring of the canister valve. Further actuating operations may therefore be conducted until the canister 5 is exhausted of its drug formulation content. As will be appreciated by the skilled reader in the art, the return spring (not shown) of the valve of the valved canister may also provide return biasing energy.
In a detailed aspect, during the return operation each inner protruding foot 35 a, 35 b of each flexible leg 34 a, 34 b interacts with each inner ramp 43 a, 43 b of the extension collar 340, the effect of this interaction being to push each flexible leg 34 a, 34 b outwards to the ‘at rest’ state of FIGS. 2, 3 a and 6 a, in which each flexible leg 34 a, 34 b is un-flexed.
FIG. 7 shows a particular detail of the first drug dispenser device of FIGS. 1 to 6 e. For succinctness, only those parts relevant to this detail are now described further.
As previously described, the container collar 30 is provided at its underside with two downward protrusions 38 a, 38 b. The mouthpiece cover 16 is further provided with P-shaped cam interference elements 17 a, 17 b joined together by bridge element 18 and joining to the mouthpiece cover 16 by means of living hinge 19 about which the bridged interference elements 17 a, 17 b may pivot. When, as shown in FIG. 7, the mouthpiece cover 16 engages with the body 12 of the dispenser device 1 to close the mouthpiece 14 (i.e. in the mouthpiece-closed position) the interference elements 17 a, 17 b adopt a position in which they locate underneath the downward protrusions 38 a, 38 b in close proximity or abutment therewith to thereby prevent any downward movement of the container collar 30. See also FIG. 3 a. Unintended movement of the container collar 30 and hence, unintended actuation of the dispenser device 1 is hence prevented.
In a subtle point, it is noted that when the mouthpiece cover 16 is in place such that the interference elements 17 a, 17 b prevent the downward movement of the container collar 30 the levers 20 a, 20 b; return springs 50 a, 50 b; and extension collar 40 are not locked and are therefore free to move. The levers 20 a, 20 b may thus, still be compressed to the point at which their protruding ends 21 a, 21 b touch off, but without any movement of the container collar 30 and actuation of the dispenser device 1.
The relative positioning of the interference elements 17 a, 17 b and the collar protrusions 38 a, 38 b in the various stages of operation of the device 1 is shown in FIGS. 3 a to 4 c. FIG. 3 a shows the spatial relationship between these parts when the mouthpiece cover 16 is in the mouthpiece-closed position, whilst FIGS. 3 b and 4 a-4 c show the corresponding spatial relationship with the cover 16 removed and the levers being depressed inwardly to fire the device 1.
FIGS. 8 to 11 illustrate aspects of the air flow into and through the housing of the drug dispenser device of FIG. 1 during use thereof. It will be observed that the levers 20 a, 20 b in these Figures show a minor ergonomic restyling compared to the previous Figures, which restyling does not alter their technical function. For succinctness, only those parts of the drug dispenser relevant to these aspects are now described.
FIG. 8 shows the drug dispenser device 1 of FIG. 1 in a ‘ready to use’ position with the mouthpiece cover 16 removed from the mouthpiece 14. It will be noted that in this position, the mouthpiece cover 16 is pivoted to a position underneath the lower housing part 12. The opposing levers 20 a, 20 b, which protrude from apertures 11 a, 11 b provided to the front 10 a and rear 10 b upper housing parts, are in their rest position. It will also be noted that in this position, the opposing levers 20 a, 20 b act to block off the apertures 11 a, 11 b such as to prevent ingress of dirt particles or other debris into the body of the device 1.
FIG. 9 shows the drug dispenser device 1 of FIG. 1 in the ‘in use’ position, in which the opposing levers 20 a, 20 b have been moved towards each other, typically in response to a patient finger and thumb squeezing action. In this position, the opposing levers 20 a, 20 b no longer act to block off the apertures 11 a, 11 b such that air 60 a, 60 b may flow through the opened up apertures 11 a, 11 b into the upper housing part 10 a, 10 b in response to patient inhalation 61 through the mouthpiece 14.
The air flow ‘in use’ through the device 1 is now described in more detail with reference to FIGS. 10 and 11.
FIG. 10 shows one half of the device 1 of FIG. 1 in the ‘in use’ position, in which the mouthpiece 14 is revealed, and in which lever 20 b has been pushed inwards to open up aperture 11 b. External air 60 b may thus, now be drawn into the body of the device housing through this aperture 11 b (and also similarly through aperture 11 a on the other side) in response to patient inhalation through the mouthpiece 14. In other words, the patient coordinates their inhalation at the mouthpiece 14 to depression of the levers 20 a, 20 b so that the resulting airflow through the housing 10 a, 10 b, which enters via the opened apertures 11 a, 11 b and exits through the mouthpiece 14, is coincident with the release of the drug from the canister 5 caused through actuation of the levers 20 a, 20 b. The airflow thus entrains the drug into the respiratory tract of the patient.
FIG. 11 illustrates in more detail, the air flow 60 a, 62 through the body of the device 1 during use thereof (i.e. again with the device 1 in the ‘in use’ position of FIGS. 9 and 10).
Referring to FIG. 11 in more detail, the device 1 may be seen to comprise a discharge assembly in the form of a stem block assembly 3 which is integrally formed with the lower body part 12 and provides for the delivery of an aerosol spray of a drug on actuation of the inhaler. Mouthpiece 14 is a separately formed part which is fitted to the lower body part 12 and in use is gripped in the lips of the user to facilitate oral inhalation. Received within the an enclosed chamber defined by the housing parts 10 a, 10 b, 12 there is provided aerosol canister 5 which contains drug to be delivered on actuation of the inhaler and is fitted in the main body and fluidly connected to the stem block assembly 3.
The mouthpiece 14 comprises an external section 15 which is configured to be gripped in the lips of a subject and defines a substantially cylindrical, open forward end through which an aerosol spray of a drug is in use delivered on actuation of the inhaler, an essentially ‘bucket-shaped’ open chamber form internal section 17 which has a closed rear section (other than air holes 66 and spray orifice 72 described hereinafter), and a discharge outlet in the form of a nozzle outlet 70 which is coupled to a rear end of the internal section 17, such as to provide for the delivery of an aerosol spray 64 into and through the internal section 17.
With this configuration of the stem block assembly 3, the nozzle outlet 70 (or mouthpiece 14) and the nozzle block 8 (or lower housing part 12) can be formed of different materials and to different specifications which are specifically suited to their purposes.
FIG. 12 shows a variation 101 of the drug dispenser device of FIGS. 1 to 11, with like features being identified with like reference numerals. The device 101 of FIG. 12 is identical to the embodiment of FIGS. 1 to 11 in all aspects other than that the dual horizontal slot-like air holes 66 visible in FIG. 11 are replaced by an arrangement of four circular air holes 166 (only three visible in FIG. 12) about the spray orifice 172 at the rear (i.e. base of the ‘bucket’) of the internal section 117 of the mouthpiece 114. It may be seen that the four air holes 166 are arranged in a generally circular arrangement about the spray orifice 172, in this embodiment being at 90° angular displacement relative to each other. The spray orifice 172 may be centrally located in the circular arrangement of the air holes 166. As may be seen in FIG. 11, when external air 160 a is drawn through these plural spaced air holes 166 a plurality of air flows 162 is defined within the mouthpiece 114. This provides for an essentially annular air flow at the inner peripheral surface of the mouthpiece 114, which essentially sheaths the aerosol spray 164 as delivered from the spray orifice 172 of the nozzle outlet 170, thereby entraining the aerosol spray and reducing deposition at the internal surface of the mouthpiece 114.
FIGS. 25 a to 25 n show other mouthpiece forms 514 a to 514 n, which may be employed in the drug dispenser device of FIGS. 1 and 11 as an alternative to the mouthpieces 14, 114 thereof. These alternative mouthpiece forms 514 a to 514 n differ only in the size, shape and number of respective air holes 566 a to 566 n provided to the rear of the internal section 517 a to 517 n of these alternative mouthpiece forms 514 a to 514 n, which air holes 566 a to 566 n are as before, arranged about a spray orifice 572 a to 572 n.
Thus, FIGS. 25 a to 25 d and 25 i show different arrangements of four circular air holes 566 a to 566 d and 566 i; FIGS. 25 e and 25 f show different arrangements of three slot-like air holes 566 e, 566 f; FIGS. 25 g and 25 h show different arrangements of six slot-like air holes 566 g, 566 h; FIG. 25 j shows an arrangement of many circular air holes 566 j; FIG. 25 k shows an arrangement of six curved slot air holes 566 k arranged in two concentric rings; FIGS. 25 l to 25 n show different arrangements of three curved slot air holes 566 l to 566 n arranged in a ring pattern.
Other air flow pathways through the drug dispenser device are possible, for instance such as those described in U.S. Provisional Application No. 60/823,146 filed on 22 Aug. 2006 and the International (PCT) Patent Application WO-A-2008/023014 which claims priority therefrom and designates the United States of America.
The upper front part 10 a of the drug dispenser device 1, 101 of FIGS. 1 and 12 is arranged for receipt and housing of an actuation counter. FIGS. 13 to 19 b provide details of the workings of a suitable actuation counter. FIGS. 20 to 22 show more details of the interaction of the actuation counter with the actuating mechanism of the drug dispenser device 1, 101.
Referring now to FIG. 13, this shows an actuation counter 201 for use with the drug dispenser device 1, 101 herein. FIGS. 14 a and 14 b respectively show underside and top views of the actuation counter 201.
The actuation counter 201 is comprised within upper front part 10 a of the drug dispenser device 1 (or 101) provided with first 212 and second 214 spindle mountings, each capable of defining an axis of rotation and a circumferential wall 218 defining a bezel form retainer 219. A viewing window 216 is provided to the housing to enable the viewing of the count. As will be understood by a comparison of FIG. 1 with FIG. 14 b, the oval-shaped front face 101 of the upper front part 10 a is covered with a correspondingly shaped label 103 to cover the apertures in the front face 101 shown in FIG. 14 b, but not the viewing window 216. In other words, the label has an aperture 105 which registers with the viewing window 216. In an alternative embodiment, the label 103 may itself have a transparent portion in place of the aperture 105 to enable observation of the viewing window 216.
Now describing the workings of the actuation counter in more detail: First, disc-shaped count wheel 220 has ‘units’ (Le. numerals) count indicia 222 provided at spaced intervals on a top face thereof. The first count wheel 220 is provided with a central aperture 226 and a circular cavity 223 that is arranged for disposed receipt of ratchet wheel 250. Ratchet drive receipt teeth 224 are arranged about the inner circumferential wall 225 of the cavity for ratcheted drive interaction with the ratchet wheel 250. The ratchet wheel 250 itself, is sized and shaped for receipt by the circular cavity 223 of the first count wheel and is provided with two oppositely-located drive tongues 252 a, 252 b for ratcheted drive interaction with the ratchet drive receipt teeth 224. The ratchet wheel 250 is also provided with a drive-receiving protrusion 254 arranged in use, for drivable rotation of the ratchet wheel 250. As will be described in more detail hereinafter with reference to FIGS. 20 to 22, the drive-receiving protrusion 254 receives drive in response to drive interaction with downward drive slot 82 provided to front plate 80 in which the drive-receiving protrusion 254 is located. The front plate 80 is permanently fixed to the container collar 30 so as to move in tandem therewith. In this embodiment, the front plate 80 is permanently fixed to the container collar 30 by ultrasonic welding.
Second, ring form count wheel 230 also has ‘tens of units’ (i.e. decimals) count indicia 232 provided at spaced intervals on a top face 237 thereof and a set of teeth 234 provided in annular arrangement to the underside thereof. It may be noted that at stop position 238, a couple of the teeth 234 have been removed and further that the outer circumferential edge of top face 237 is formed with a series of equally spaced notches or indentations 236. The reasons for these features will become clear from the later description. The second count wheel 230 is also provided with a protruding shutter 280, the function of which will also be described later.
As may be best seen at FIG. 14 a, when assembled, second count wheel 230 is received for rotation within the bezel form retainer 219 of the housing; and first count wheel 220 is received within the inner ring void 235 defined by ring-shaped second count wheel 230 and its central aperture 226 by first spindle 212 such that clearance exists between the first 220 and second 230 count wheels. Thus, the first 220 and second 230 count wheels are in concentric relationship, but the level of the second count wheel 230 is slightly raised relative to that of the first count wheel 220 to enable shutter 280 to protrude over and above the first count wheel 220. Ratchet wheel 250 is received within the circular cavity 223 of the first count wheel 220 such that drive tongues 252 a, 252 b engage with the ratchet drive receipt teeth 224. Both wheels 220, 230 and the ratchet wheel 250 are rotatable about a common first axis of rotation F-F defined in combination by the axis of first spindle 212 and the circular shape of the bezel retainer 219. The drive-receiving protrusion 254 is offset from the first axis F-F, as is the drive slot 82. Moreover, the protrusion 254 and drive slot 82 are both offset to the longitudinal axis L-L.
Kick wheel 240 is received by second spindle 214 for rotation about a second axis of rotation S-S defined by the second spindle 214 and therefore offset from the first axis of rotation F-F. It will be appreciated that the second axis of rotation S-S is spaced from the first axis of rotation F-F to be outside ‘the path of ‘rotation defined by the outwardly-facing teeth 234 of the second count wheel 230. Moreover, the first and second axes F-F, S-S are parallel, or substantially parallel, to each other.
As will be described in more detail hereinafter, when the actuation counter 201 is disposed in the drug dispenser 1, 101 the ratchet wheel 250 is in turn drivably rotatable about the first axis F-F by the drive-receiving interaction of protrusion 254 with downward drive slot 82 provided to front plate 80. The front plate 80 fixes to the container collar 30, which is itself drivable downwards in response to effective user actuation of the drug dispenser device 1, 101.
First count wheel 220 may also be seen to be provided at its periphery with a pair of fixed index teeth 228 a, 228 b (as may be best seen in FIG. 16 a) arranged for intermittent meshing with the kick teeth 244 of the kick wheel 240 such that rotary motion of the kick wheel 240 results from rotary motion of the first count wheel 220 only when said intermittent meshing occurs.
In a further subtle aspect, the counter 201 is arranged to count down from ‘120’ to a ‘shuttered position’. The second count wheel 230 is thus, arranged to define fourteen equal pitches allied to twenty-six (calculated as (2×14)−2) teeth 234 plus two missing teeth at stop position 238. The number of pitches is defined as x+2, wherein x is the highest numeral on the second count (i.e. decimals) wheel, which in turn corresponds to a highest count of 10 times× (i.e. 10×12=120, in this embodiment). The ‘+2’ part of the sum determining the number of pitches relates to one coloured portion 282 and one shutter portion 280, as are described in more detail later.
Operation of the actuation counter 201 is now described with additional reference to FIGS. 15 a to 17 b, in which only the most relevant features to the described operation are labelled. The actuation counter 201 is arranged to count down and thus, to illustrate a count operation, FIGS. 15 a, 17 a and 17 a show the actuation counter 201 at a ‘count 120’ position and FIGS. 15 b, 16 b and 17 b show the actuation counter 201 at a ‘count 119’ position (i.e. just after counting down from 120).
To initiate a general count operation, ratchet wheel 250 is rotated in response to effective user actuation of the drug dispenser device 1, 101 by squeezing the levers 20 a, 20 b together as described with reference to FIGS. 1 to 6 e above. This results in the drive slot 82 driving the ratchet wheel protrusion 254 to rotate the ratchet wheel 250 in a first rotary sense (clockwise in FIGS. 13 and 14 a). This, in turn, results in rotation of the first count wheel 220 in the first rotary sense by the meshed interaction of drive tongues 252 a, 252 b with ratchet drive receipt teeth 224. The ratchet wheel 250 and first count wheel 220 are configured and arranged such that when indexed first count wheel 220 rotates by 36° such that a single indicium 222 thereon is advanced (i.e. the ‘units’ count moves down one unit).
Where the pre-count operation visible count is x0 (e.g. 120 with ‘x=12’, as shown at FIGS. 15 a, 16 a and 17 a), the counting action resulting from the use operation is subtly different. Once again, ratchet wheel 250 is rotated in response to effective user actuation of the drug dispenser device 1, 101 causing rotation of the first count wheel 220 by 36° such that the ‘unit’ indicium 222 moves on from ‘0’ to ‘9’ (as shown at FIGS. 15 b and 16 b). This rotation of the first count wheel 220 however, also brings the pair of index teeth 228 a, 228 b into meshed relationship with the kick teeth 244 of kick wheel 240 such that the kick wheel 240 rotates and in turn, causes the second count wheel 230 to rotate through meshing of their respective teeth 234, 244. The wheels 220, 230, 240 are configured and arranged such that the resultant rotation of the second count wheel 230 is by 360/14° (that is to say by 360/n° wherein n is the number of number spacings, where in this case n=14 because there are twelve decimals indicia 232; one shutter portion 280 and one coloured portion 282) such that a single indicium 232 thereon is advanced (i.e. the ‘tens’ count moves down exactly one unit). In this instance, the decimal indicium 232 moves down from ‘12’ to ‘11’, as shown in FIGS. 15 a and 15 b.
As shown at FIGS. 18 a and 19 a, where the previous visible count was ‘red 0’ (i.e. x=0), the counting action resulting from the use operation is still again subtly different in that the kick wheel 240 action, as described above, results in the shutter portion 280 of the second count wheel 230 being advanced into place in the window 216 such that the next display is fully shuttered off (i.e. no indicia 222, 232 visible at all, as shown at FIGS. 18 b and 19 b). Additionally, the stop position 238 in the set of second count wheel teeth 234 is brought into opposed relation with the kick teeth 244 whereby the kick teeth 244 and the teeth 234 no longer mesh. Thus, if the first count wheel 220 continues to rotate, e.g. in response to continued user operation of the drug dispenser device 1, 101 into which the actuation counter 201 is incorporated, notwithstanding that all drug doses in the prescribed dosing regime have been dispensed (although surplus doses may remain in the canister 5 for patient administration in accordance with regulatory requirements, as understood by the skilled person in the art), the index teeth 228 a, 228 b of the first count wheel 220 will still intermittently mesh with the kick teeth 244 to cause the kick wheel 240 to rotate. However, this rotation of the kick wheel 240 will not be transmitted to the second count wheel 230, due to the missing teeth of stop position 238, and the shutter 280 remains in the shuttering position in the window 216 so that the underlying ‘units’ indicium 222 remains unseen.
To further illustrate the countdown display of the counter 201, the reader's attention is drawn to Table 1 below. Table 1 shows the sequential countdown for each of the units (first) and decimals (second) count wheels 220, 230 upon succeeding use operations or actuations of the counter 201, and also indicates which of these two count wheels 220, 230 indexes to bring the counter 201 to its new counter display. As shown in Table 1, the first (units) count wheel 220 indexes on each counter 10 actuation, whereas the second (decimals) count wheel 230 only indexes (through the kick wheel 240 supra) each time the units indicium 222 of the first (units) count wheel 220 in the window 216 decrements from ‘0’ to ‘9’. At the end of the countdown, when the display is shuttered, the first count wheel 220 is still free to rotate, underneath the shutter 280 so as not to be visible, and no further indexing of the second count wheel 230 occurs due to the stop position 238 providing for disengagement of the teeth 234, 244 of the second count wheel 230 and the kick wheel 240.
Sequential Indexing of Indexing of
Counter Decimals Units Wheel Units Wheel Decimal Wheel
Display in Wheel Count Count in to this to this
Window in Window Window Count? Count?
120  12 0 — —
119  11 9 Yes Yes
109  10 9 Yes Yes
Thus, the ratchet wheel 250 is adapted to not only rotate in the cavity 223 of the first count wheel 220 in the first rotary sense (clockwise as viewed in FIGS. 13 and 14 a), but also to rotate in an opposite, second rotary sense (anti-clockwise as viewed in FIGS. 13 and 14 a) in the first count wheel cavity 223.
However, while rotation of the ratchet wheel 250 in the first rotary sense drivably rotates the first count wheel 220 in the first rotary sense for indexing of the units count 222 in the window 216, rotation of the ratchet wheel 250 in the opposite, second rotary sense is relative to the first count wheel 220; i.e. the first count wheel 220 remains stationary so that the units indicia 222 in the window 216 remains unchanged. That is to say, frictional engagement between the respective wheels 220, 250 does not result in reverse rotation of the first count wheel 220, except for tolerance adjustments as discussed below.
To this end, the first count wheel 220 is provided with a pair of diametrically opposed resilient tongues or pawls 227 which co-operate with a serrated circumferential surface 211 of the first spindle 212 a. The serrated surface 211 comprises plural ratchet teeth 215 with which the free ends 227 a of the pawls 227 engage. As the skilled person will understand, as the first count wheel 220 is driven by the ratchet wheel 250 to rotate in the first sense, the free ends 227 a of the pawls 227 ride over the respective ratchet tooth 215 presently engaged with and drop onto the next adjacent ratchet tooth 215 in the first sense, there being a step between adjacent teeth 215. This then indexes the first count wheel 220 in its new position, at which the next units indicia 222 in the count sequence registers with the window 216. However, the step between the adjacent ratchet teeth 215 prevents the first count wheel 220 rotating back in the opposite, second sense as the ratchet wheel 250 so rotates as the pawl free ends 227 a cannot pass thereover.
As will also be appreciated by the skilled person, the ratchet teeth 215 provide tolerances in the indexing rotation of the first count wheel 220 by the ratchet wheel 250. In other words, the first count wheel 220 can be slightly over-rotated in the first sense, but as the ratchet wheel 250 rotates back in the opposite, second sense it carries the first count wheel 220 in the same sense, through frictional forces, until the pawl free ends 227 a engage the step between the ratchet teeth 215 which then prevents further reverse rotation of the first count wheel 220 and indexes the units indicia 222 in the window 216.
As shown in FIGS. 13 and 14 b, for example, the upper front part 210 of the drug dispenser device 1, 201 further provides a resilient pawl 217. The pawl 217 has a free end 217 a which engages the indentations 236 in the outer circumferential surface of the top face 237 of the second count wheel 230, as shown in FIGS. 15 a and 15 b, for instance. There is one indentation 236 for each count or index position of the second count wheel 230, so the free end 217 a of the pawl 217 and the indentations 236 provide an indexing function which provides for accurate alignment of the decimals indicia 234 in the window 216 and inhibits or prevents reverse rotation of the second count wheel 230.
The indentations 236 in this embodiment have a symmetrical shape, more particularly a generally U-shape. However, other shapes could be used. Moreover, asymmetric shapes could also be used. For instance, it may be useful for the flanks of the indentations 236 to present different angles, for example for the trailing (rear) flanks of the indentations 236 (relative to the direction of rotation of the second count wheel 230, e.g. anti-clockwise in FIGS. 15 a and 15 b) to form a greater angle with a central radial line through the indentations 236 than the leading (forward) flanks. This means there is less resistance to the pawl 217 releasing from the indentations 236 as the second count wheel 230 is driven by the kick wheel 240.
In a modification of the counter 201 (not shown), the friction resistance between the kick wheel 240 and its spindle mounting 214 may be increased to provide a dragging or braking effect which retards the speed of rotation of the kick wheel 240 when driven by the first count wheel 220. One possible way to achieve this is through the provision of axially-oriented splines about the outer periphery of the spindle mounting 214. This may prevent or inhibit any tendency for the second count wheel 230 to be misaligned or over-indexed by a fast moving kick wheel 240.
The interrelationship between the actuation counter 201 and the drug dispenser device 1 is now described in more detail with reference to FIGS. 20 to 22. For clarity and succinctness, only relevant parts of FIGS. 20 to 22 are labelled.
FIG. 20 shows the drug dispenser device 1 with upper front cover part 10 a and actuation counter 201 removed. The device 1 is in the ‘at rest’ position with the levers 20 a, 20 b not depressed.
FIG. 21 shows the drug dispenser device 1 with the upper front cover part 10 a and actuation counter 201 disposed therein shown detached from the remainder of the device 1. The drug dispenser device 1 is again in the ‘at rest’ position with the levers 20 a, 20 b not depressed. FIG. 22 shows further details of the actuation counter 201 disposed in the upper front cover part 10 a of the drug dispenser device 1.
Arrow A of FIG. 21 indicates the direction of movement of the container collar 30 and front plate 80 attached thereto resulting from effective user actuation of the drug dispenser device. Arrow B of FIG. 21 indicates the resulting interaction between the downward drive slot 82 of the front plate 80 and the drive-receiving protrusion 254 of the ratchet wheel 250 of the actuation counter 201.
Detailed aspects of the drug dispenser device 1 and actuation counter 201 of FIGS. 20 to 22 correspond to those already described by reference to FIGS. 1 to 12 and FIGS. 13 to 19 b respectively, and for succinctness these are not described further.
Registration of a count is now described. In use, following effective user actuation of the drug dispenser device 1 by squeezing the levers 20 a, 20 b together, as described hereinabove with reference to FIGS. 1 to 6 e, the container collar 30 and front plate 80 move downwards in tandem. The downward drive slot 82 on the front plate 80 drivably engages the drive-receiving protrusion 254 to drive on the ratchet wheel 250 of the actuation counter thereby resulting in registration of a count. As described previously, effective user actuation which results in the downward movement of the container collar 30 (and actuation of drug release from the canister 5) occurs only once a pre-load threshold (‘tipping’) force has been overcome (by that effective user actuation). Thus, it will also be appreciated that a count is only registered by the actuation counter 201 in response to such an effective user actuation. The registered count thus, fully ties in with the number of occurrences of drug release.
The illustrated drug dispenser devices in accordance with the present invention have inter alia the following advantages:
a “reduced force to fire” through use of the side levers;
a lock-out to prevent inadvertent firing of the device;
a patient independent firing characteristic through provision of the commitment feature;
an inhalation airflow path which sheaths the drug plume in the mouthpiece thereby reducing deposition of drug on the mouthpiece;
a closed-off internal mouthpiece geometry which makes it easier to keep the mouthpiece clean; and
a multi-part stem block which enables complex moulding geometries to be used for the spray channel.
Each of the above-described embodiments may be modified to incorporate one or more features disclosed in the U.S. Provisional and/or International Applications incorporated herein by reference in the second to fourth paragraphs hereof.
Appropriate drugs may thus be selected from, for example, analgesics, e.g., codeine, dihydromorphine, ergotamine, fentanyl or morphine; anginal preparations, e.g., diltiazem; antiallergics, e.g., cromoglycate (e.g. as the sodium salt), ketotifen or nedocromil (e.g. as the sodium salt); antiinfectives e.g., cephalosporins, penicillins, streptomycin, sulphonamides, tetracyclines and pentamidine; antihistamines, e.g., methapyrilene; anti-inflammatories, e.g., beclomethasone (e.g. as the dipropionate ester), fluticasone (e.g. as the propionate ester), flunisolide, budesonide, rofleponide, mometasone e.g. as the furoate ester), ciclesonide, triamcinolone (e.g. as the acetonide) or 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxy-androsta-1,4-diene-17β-carbothioic acid S-(2-oxo-tetrahydro-furan-3-yl)ester; antitussives, e.g., noscapine; bronchodilators, e.g., albuterol (e.g. as free base or sulphate), salmeterol (e.g. as xinafoate), ephedrine, adrenaline, fenoterol (e.g. as hydrobromide), salmefamol, carbuterol, mabuterol, etanterol, naminterol, clenbuterol, flerbuterol, bambuterol, indacaterol, formoterol (e.g. as fumarate), isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine, pirbuterol (e.g. as acetate), reproterol (e.g. as hydrochloride), rimiterol, terbutaline (e.g. as sulphate), isoetharine, tulobuterol or 4-hydroxy-7-[2-[[2-[[3-(2-phenylethoxy)propyl]sulfonyl]ethyl]amino]ethyl-2(3H)-benzothiazolone; adenosine 2a agonists, e.g. 2R,3R,4S,5R)-2-(6-Amino-2-(1S-hydroxymethyl-2-phenyl-ethylamino)purin-9-yl]-5-(2-ethyl-2H-tetrazol-5-yl)-tetrahydro-furan-3,4-diol (e.g. as maleate); α4 integrin inhibitors e.g. (2S)-3-[4-({[4-(aminocarbonyl)-1-piperidinyl]carbonyl}oxy)phenyl)-2-[((2S)-4-methyl-2-{[2-(2-methylphenoxy)acetyl]amino}pentanoyl)amino]propanoic acid (e.g. as free acid or potassium salt), diuretics, e.g., amiloride; anticholinergics, e.g., ipratropium (e.g. as bromide), tiotropium, atropine or oxitropium; hormones, e.g., cortisone, hydrocortisone or prednisolone; xanthines, e.g., aminophylline, choline theophyllinate, lysine theophyllinate or theophylline; therapeutic proteins and peptides, e.g., insulin or glucagon; vaccines, diagnostics, and gene therapies. It will be clear to a person skilled in the art that, where appropriate, the drugs may be used in the form of salts, (e.g., as alkali metal or amine salts or as acid addition salts) or as esters (e.g., lower alkyl esters) or as solvates (e.g., hydrates) to optimise the activity and/or stability of the drug.
Suitable anti-inflammatory agents include corticosteroids and NSAIDs. Suitable corticosteroids which may be used in combination with the compounds of the invention are those oral and inhaled corticosteroids and their pro-drugs which have anti-inflammatory activity. Examples include methyl prednisolone, prednisolone, dexamethasone, fluticasone propionate, 6α,9α-difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester, 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxy-androsta-1,4-diene-17β-carbothioic acid S-(2-oxo-tetrahydro-furan-3S-yl) ester, beclomethasone esters (e.g. the 17-propionate ester or the 17,21-dipropionate ester), budesonide, flunisolide, mometasone esters (e.g. the furoate ester), triamcinolone acetonide, rofleponide, ciclesonide, butixocort propionate, RPR-106541, and ST-126. Preferred corticosteroids include fluticasone propionate, 6α,9α-difluoro-11β-hydroxy-16α-methyl-17α-[(4-methyl-1,3-thiazole-5-carbonyl)oxy]-3-oxo-androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester, 6α,9α-difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester, 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-(2,2,3,3-tetramethycyclopropylcarbonyl)oxy-androsta-1,4-diene-17β-carbothioic acid S-cyanomethyl ester, 6α,9α-difluoro-11β-hydroxy-16α-methyl-17α-(1-methycyclopropylcarbonyl)oxy-3-oxo-androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester and 9α,21 dichloro-11β,17α methyl-1,4 pregnadiene 3,20 dione-17-[2′]furoate(mometasone furoate).
Suitable bronchodilators are β2-adrenoreceptor agonists, including salmeterol (which may be a racemate or a single enantiomer, such as the R-enantiomer), for instance salmeterol xinafoate, salbutamol (which may be a racemate or a single enantiomer, such as the R-enantiomer), for instance salbutamol sulphate or as the free base, formoterol (which may be a racemate or a single diastereomer, such as the R,R-diastereomer), for instance formoterol fumarate or terbutaline and salts thereof. Other suitable β2-adrenoreceptor agonists are 3-(4-{[6-({(2R)-2-hydroxy-2-[4-hydroxy-3-(hydroxymethyl)phenyl]ethyl}amino)hexyl]oxy}butyl)benzenesulfonamide, 3-(3-{[7-({(2R)-2-hydroxy-2-[4-hydroxy-3-hydroxymethyl)phenyl]ethyl}-amino)heptyl]oxy}propyl)benzenesulfonamide, 4-{(1R)-2-[(6-{2-[(2,6-dichlorobenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl)-2-(hydroxymethyl)phenol, 4-{(1R)-2-[(6-{4-[3-(cyclopentylsulfonyl)phenyl]butoxy}hexyl)amino]-1-hydroxyethyl)-2-(hydroxymethyl)phenol, N-[2-hydroxyl-5-[(1R)-1-hydroxy-2-[[2-4-[[(2R)-2-hydroxy-2-phenylethyl]amino]phenyl]ethyl]amino]ethyl]phenyl]formamide, and N-2{2-[4-(3-phenyl-4-methoxyphenyl)aminopheny]ethyl}-2-hydroxy-2-(8-hydroxy-2(1H)-quinolinon-5-yl)ethylamine, and 5-[(R)-2-(2-{4-[4-(2-amino-2-methyl-propoxy)-phenylamino]-phenylyethylamino)-1-hydroxy-ethyl]-8-hydroxy-1H-quinolin-2-one. Preferably, the β2-adrenoreceptor agonist is a long acting β2-adrenoreceptor agonist (LABA), for example a compound which provides effective bronchodilation for about 12 hours or longer.
Preferred phosphodiesterase 4 (PDE4) inhibitors are cis 4-cyano-4-(3-cyclopentyloxy-4-methoxyphenyl)cyclohexan-1-carboxylic acid, 2-carbomethoxy-4-cyano-4-(3-cyclopropylmethoxy-4-difluoromethoxyphenyl)cyclohexan-1-one and cis-[4-cyano-4-(3-cyclopropylmethoxy-4-difluoromethoxyphenyl)cydohexan-1-ol].
Other suitable drug compounds include: cis-4-cyano-4-[3-(cyclopentyloxy)-4-methoxyphenyl]cyclohexane-1-carboxylic acid (also known as cilomalast) disclosed in U.S. Pat. No. 5,552,438 and its salts, esters, pro-drugs or physical forms; AWD-12-281 from elbion (Hofgen, N. et al. 15th EFMC Int Symp Med Chem (September 6-10, Edinburgh) 1998, Abst P.98; CAS reference No. 247584020-9); a 9-benzyladenine derivative nominated NCS-613 (INSERM); D-4418 from Chiroscience and Schering-Plough; a benzodiazepine PDE4 inhibitor identified as CI-1018 (PD-168787) and attributed to Pfizer; a benzodioxole derivative disclosed by Kyowa Hakko in WO99/16766; K-34 from Kyowa Hakko; V-11294A from Napp (Landells, L. J. et al. Eur Resp J [Annu Cong Eur Resp Soc (September 19-23, Geneva) 1998] 1998, 12 (Suppl. 28): Abst P2393); roflumilast (CAS reference No 162401-32-3) and a pthalazinone (WO99/47505, the disclosure of which is hereby incorporated by reference) from Byk-Gulden; Pumafentrine, (−)-p-[(4aR*,10bS*)-9-ethoxy-1,2,3,4,4a,10b-hexahydro-8-methoxy-2-methylbenzo[c][1,6]naphthyridin-6-yl]-N,N-diisopropylbenzamide which is a mixed PDE3/PDE4 inhibitor which has been prepared and published on by Byk-Gulden, now Altana; arofylline under development by Almirall-Prodesfarma; VM554/UM565 from Vernalis; or T-440 (Tanabe Seiyaku; Fuji, K. et al. J Pharmacol Exp Ther, 1998, 284(1): 162), and T2585.
Piperazines: hydroxyzine HCl, hydroxyzine pamoate, cyclizine HCl, cyclizine lactate, meclizine HCl, and cetirizine
Suitably, the drug formulation includes one or more of a β2-adrenoreceptor agonist, a corticosteroid, a PDE-4 inhibitor and an anti-cholinergic.
In one embodiment, the drug is formulated as any suitable aerosol formulation, optionally containing other pharmaceutically acceptable additive components. In embodiments, the aerosol formulation comprises a suspension of a drug in a propellant. In embodiments; the propellant is a fluorocarbon or hydrogen-containing chlorofluorocarbon propellant.
Suitable preservatives include quatemary ammonium compounds (e.g. benzalkonium chloride, benzethonium chloride, cetrimide and cetylpyridinium chloride), mercurial agents (e.g. phenylmercuric nitrate, phenylmercuric acetate and thimerosal), alcoholic agents (e.g. chlorobutanol, phenylethyl alcohol and benzyl alcohol), antibacterial esters (e.g. esters of para-hydroxybenzoic acid), chelating agents such as disodium edetate (EDTA) and other anti-microbial agents such as chlorhexidine, chlorocresol, sorbic acid and its salts and polymyxin.
Administration of drug in aerosolized form may be indicated for the treatment of mild, moderate or severe acute or chronic symptoms or for prophylactic treatment. It will be appreciated that the precise dose administered will depend on the age and condition of the patient, the particular particulate drug used and the frequency of administration and will ultimately be at the discretion of the attendant physician. When combinations of drugs are employed the dose of each component of the combination will in general be that employed for each component when used alone. Typically, administration may be one or more times, for example from 1 to 8 times per day, giving for example 1, 2, 3 or 4 aerosol puffs each time. Each valve actuation, for example, may deliver 5 μg, 50 μg, 100 μg, 200 μg or 250 μg of a drug. Typically, each filled canister for use in a metered dose inhaler contains 60, 100, 120 or 200 metered doses or puffs of drug; the dosage of each drug is either known or readily ascertainable by those skilled in the art.
In another embodiment, the drug dispenser device herein is suitable for dispensing fluid drug formulations for the treatment of inflammatory and/or allergic conditions of the nasal passages such as rhinitis e.g. seasonal and perennial rhinitis as well as other local inflammatory conditions such as asthma, COPD and dermatitis. A suitable dosing regime would be for the patient to inhale slowly through the nose subsequent to the nasal cavity being cleared. During inhalation the formulation would be applied to one nostril while the other is manually compressed. This procedure would then be repeated for the other nostril. Typically, one or two inhalations per nostril would be administered by the above procedure up to three 10 times each day, ideally once daily. Each dose, for example, may deliver 5 μg, 50 μg, 100 μg, 200 μg or 250 μg of active drug. The precise dosage is either known or readily ascertainable by those skilled in the art.
1. A drug dispenser device comprising
(b) extending from said housing, an outlet for insertion into a body cavity of a patient;
(c) provided to the housing and moveable with respect thereto, a drug discharge device, said drug discharge device having a longitudinal axis and comprising a container for storing a drug formulation to be dispensed, a discharge mechanism and a discharge channel from said container for discharge of said drug formulation to said outlet;
(d) connecting to the drug discharge device, a container collar;
(e) connecting to said container collar and moveable with respect thereto along the longitudinal axis of the drug discharge device, a transfer element, said transfer element including an actuating portion;
(f) provided to the housing, at least one finger operable member moveable to apply an actuating force to said actuating portion of said transfer element to move the transfer element from an initial transfer element position along the longitudinal axis in a first direction;
(g) provided to the container collar, a pre-load mechanism to prevent transfer of said actuating force to the container collar to move said drug discharge device along the longitudinal axis in the first direction to actuate the discharge mechanism until a pre-determined threshold force is overcome; and
(h) connecting the container collar with the transfer element, a biasing return mechanism acting to bias the transfer element along the longitudinal axis in a second direction to return the transfer element to the initial transfer element position.
3. A drug dispenser device according to either of claims 1 or 2, wherein the outlet is provided with a removeable protective cover.
5. A drug dispenser device according to any of claims 1 to 4, wherein the discharge channel extends out from the neck of the container.
6. A drug dispenser device according to any of claims 1 to 5, wherein the discharge channel is received by a cavity or passage provided to a part of the housing, which cavity or passage enables communication with the outlet for dispensing of discharged drug to a patient.
7. A drug dispenser device according to any of claims 1 to 6, wherein the container collar permanently engages with the container.
8. A drug dispenser device according to any of claims 1 to 7, wherein the container collar engages with the neck of the container by means of a split-ring collar provided thereto.
9. A drug dispenser device according to any of claims 1 to 8, wherein the transfer element comprises an extension collar.
11. A drug dispenser device according to any of claims 1 to 10, wherein the actuating portion defines an abutment surface.
12. A drug dispenser device according to any of claims 1 to 11, wherein the at least one finger operable member defines a bearing surface.
13. A drug dispenser device according to any of claims 1 to 12, wherein the at least one finger operable member is arranged to apply mechanical advantage.
18. A drug dispenser device according to either of claim 16 or 17, wherein the or each lever is pivotally supported at a lower end of the housing.
19. A drug dispenser device according to any of claims 1 to 18, additionally comprising a locking mechanism for reversibly locking the movement of the at least one finger operable member.
20. A drug dispenser device according to any of claims 1 to 18, additionally comprising a locking mechanism for reversibly locking the movement of the container collar.
22. A drug dispenser device according to any of claims 19 to 21, wherein the locking mechanism comprises a locking element selected from the group consisting of a limb, protrusion, and abutment.
23. A drug dispenser device according to any of claims 19 to 22, wherein the locking mechanism is provided integral to a removeable cover for the outlet.
24. A drug dispenser device according to any of claims 1 to 23, wherein the biasing return mechanism comprises one or more springs.
25. A drug dispenser device according to claim 24, wherein the biasing return mechanism comprises an arrangement of two springs locating one on either side of the container collar.
26. A drug dispenser device according to either of claim 24 or 25, wherein the biasing return mechanism comprises one or more extension springs.
27. A drug dispenser device according to any of claims 1 to 26, wherein the pre-determined threshold force is in the range from 5 to 30N.
28. A drug dispenser device according to any of claims 1 to 27, wherein the pre-load mechanism is interposed between the container collar and the housing.
29. A drug dispenser device according to claim 28, wherein the pre-load mechanism comprises one or more detents provided to the container collar for reversible engagement with part of the housing.
30. A drug dispenser device according to claim 29, wherein the or each detent comprises a flexible support limb.
31. A drug dispenser device according to claim 30, wherein said flexible support limb is arranged for reversible engagement with a step or abutment provided to the housing.
32. A drug dispenser device according to either of claim 30 or 31, wherein the pre-load mechanism comprises an arrangement of from two to four flexible support limbs.
33. A drug dispenser device according to any of claims 30 to 32, wherein a guide mechanism is provided to the extension collar for guiding the disengagement of the or each flexible support limb.
34. A drug dispenser device according to claim 33, wherein said guide mechanism comprises a guide ramp, which interacts with a shaped head of the or each flexible support limb.
35. A drug dispenser device according to any of claims 30 to 34, wherein a reseat guide mechanism is provided to the extension collar for guiding the re-engagement of the or each flexible support limb.
36. A drug dispenser device according to claim 35, wherein said reseat guide mechanism comprises a reseat guide ramp, which interacts with a shaped reseat head of the or each flexible support limb.
37. A drug dispenser device according to claim 28, wherein the pre-load mechanism comprises one or more detents provided to the housing for reversible engagement with part of the container collar.
38. A drug dispenser device according to any of claims 1 to 37, additionally comprising an actuation counter.
39. A drug dispenser device according to claim 38, wherein the actuation counter is actuable in response to movement of the container collar or of the container along the longitudinal axis in the first direction.
40. A drug dispenser device according to claim 39, wherein the actuation counter is actuable in response to drive interaction with a driver element provided to the container collar or container.
41. A drug dispenser device according to claim 40, wherein said driver element takes the form of a protrusion, an abutment, an indent or a slot provided to the container collar or container.
42. A drug dispenser device according to claim 39, wherein the actuation counter is actuable in response to drive interaction with a driver element provided to a drive feature connecting to the container collar or container.
43. A drug dispenser device according to claim 42, wherein said driver element takes the form of a protrusion, an abutment, an indent or a slot provided to said drive feature.
44. A drug dispenser device according to either of claim 42 or 43, wherein the drive feature comprises a plate connecting to the container collar.
45. A drug dispenser device comprising:
a housing which comprises an outlet for insertion into a body cavity of a patient,
a drug discharge device in the housing comprising a container for storing a drug formulation to be dispensed and a discharge mechanism for discharge of said drug formulation from said container to said outlet, the drug discharge device disposed in the housing such that the discharge mechanism is held stationary and the container is movable in a first direction relative to the discharge mechanism to put the device in a discharge mode where the formulation is discharged from the container to the outlet;
a transfer arrangement for transferring the container in the first direction relative to the discharge mechanism comprising a first part attached to the container, a second part connected to the first part so that the first and second parts are movable towards and away from each other, a return biasing force mechanism for biasing the first and second parts to a resting configuration thereof, a latch adapted in use to latch the first part against movement in the first direction, and a latch release adapted for releasing the latch, when an actuating force of greater than a pre-determined threshold force is applied to the second part in the first direction, to enable the actuating force to move the first part in the first direction and carry the container in the first direction relative to the discharge mechanism to put the drug discharge device in its discharge mode.
46. A drug dispenser device according to claim 45, additionally comprising an actuation counter configured and arranged to be actuated by movement of the first part or the container in the first direction on release of the latch.
47. A drug dispenser device according to either of claim 45 or 46, wherein the latch is provided on the first part and the latch release is provided on the second part.
48. A drug dispenser device according to any of claims 45 to 47, wherein the first part is a collar.
49. A drug dispenser device according to any of claims 45 to 48, wherein the second part is a collar.
50. A drug dispenser device according to any of claims 45 to 49, wherein the latch is formed by one or more projections of the first part.
51. A drug dispenser device according to any of claims 45 to 50, wherein the latch release is formed by a surface thereof for contacting the latch for release thereof.
52. A drug dispenser device according to any of claims 45 to 51, wherein the return biasing force is provided by a resilient element.
53. A drug dispenser device according to claim 52, wherein the resilient element is a spring.
54. A drug dispenser device according to any of claims 45 to 53, wherein the device has an actuating mechanism for moving the second part of the transfer arrangement.
55. A drug dispenser device according to claim 54, wherein the actuating mechanism comprises at least one finger operable member.
56. A drug dispenser device according to claim 55, wherein said at least one finger operable member consists of one or more levers.
57. A drug dispenser device according to any of claim 38 to 44 or 46, wherein the actuation counter is provided as an assembly for insertion into the drug dispenser.
58. A drug dispenser device according to any of claim 38 to 44 or 46 or 57, wherein an inner wall of the housing of the drug dispenser acts as a mounting for some or all of the parts of the actuation counter.
59. A drug dispenser device according to any of claim 38 to 44 or 46 or 57 or 58, wherein the actuation counter comprises one or more count wheels provided with count indicia thereon for display of the actuation count.
60. A drug dispenser device according to claim 59, wherein the actuation counter comprises:
61. A drug dispenser device according to claim 60, wherein the actuation counter is configured and arranged so that said intermittent meshing is able to occur a plurality of times.
62. A drug dispenser device according to either of claim 60 or 61, wherein the first or second count wheel has the form of a disc or a ring.
63. A drug dispenser device according to any of claims 60 to 62, wherein said one or more drive receipt elements of the first wheel comprise one or more teeth and/or indents.
64. A drug dispenser device according to any of claims 60 to 63, wherein the one or more drive receipt elements of the first count wheel are arranged annularly.
65. A drug dispenser device according to claim 64, wherein the one or more drive receipt elements of the first count wheel are arranged about an inner or outer circumferential wall of the first count wheel.
66. A drug dispenser device according to any of claims 60 to 62 further comprising a ratchet, and wherein the one or more drive receipt elements of the first count wheel comprise one or more ratchet drive receipt elements arranged thereon for receipt of drive from said ratchet.
67. A drug dispenser according to claim 66, wherein the ratchet is a ratchet wheel arranged for rotation about the first axis of rotation.
68. A drug dispenser according to either of claim 66 or 67, wherein the ratchet wheel is provided with one or more ratchet drive tongues.
69. A drug dispenser according to any of claims 66 to 68, wherein said one or more ratchet drive receipt elements are arranged annularly about the first count wheel.
70. A drug dispenser according to any of claims 66 to 69, wherein the one or more ratchet drive receipt elements are selected from the group consisting of one or more teeth and indents.
71. A drug dispenser according to any of claims 66 to 70, wherein at least one of the first and second count wheels has the form of a disc or a ring.
72. A drug dispenser according to claim 71, wherein the first count wheel is provided with a circular cavity that is arranged for receipt of the ratchet wheel, and the ratchet drive receipt elements are arranged about the inner circumferential wall of the cavity for ratcheted drive interaction with the ratchet wheel.
73. A drug dispenser according to claim 71, wherein the first count wheel has the form of a ring that is arranged for disposed receipt of the ratchet wheel, and the ratchet drive receipt elements are arranged about the inner circumferential wall of the ring for ratcheted drive interaction with the ratchet wheel.
74. A drug dispenser according to any of claims 66 to 73, wherein the ratchet is provided with one or more drive receipt elements for receipt of drive that results in movement thereof.
75. A drug dispenser according to claim 74, wherein said one or more drive receipt elements of the ratchet have a form selected from the group consisting of one or more teeth, protrusions and indents.
76. A drug dispenser according to any of claims 66 to 75, wherein the teeth of the second count wheel are provided on an outwardly-facing circumferential surface of the second count wheel.
77. A drug dispenser according to any of claims 66 to 75, wherein the second axis of rotation lies outside the path of rotation defined by the second count wheel teeth.
78. A drug dispenser according to any of claims 60 to 77, wherein the second count wheel teeth are arranged circumferentially on the second count wheel.
79. A drug dispenser according to any of claims 60 to 78, wherein the second count wheel is arranged concentric to the first count wheel.
80. A drug dispenser according to any of claims 60 to 79, wherein the second count wheel takes the form of a ring and the first count wheel is disposed within the ring.
81. A drug dispenser according to any of claims 60 to 80, wherein the kick teeth are arranged circumferentially on the kick wheel.
82. A drug dispenser according to any of claims 60 to 81, wherein the at least one index tooth is fixed at a point at or about the circumference of the first count wheel and rotation of the first count wheel is arranged to bring the at least one index tooth into meshed relationship with the kick teeth of the kick wheel at a particular point of the rotary cycle of the first count wheel such that meshing occurs once during each complete rotation of the first count wheel.
83. A drug dispenser according to any of claims 60 to 82, wherein the actuation counter has a reverse rotation mechanism for interacting with either one or both counter wheels to prevent reverse movement thereof.
84. A drug dispenser according to claim 83, wherein the reverse rotation mechanism includes a ratchet comprising a cam surface arranged to interact with a cam follower provided to one or both of the count wheels.
85. A drug dispenser according to claim 84, wherein the cam surface is shaped to assist correct alignment of the indicia on the count wheels to provide a clear count reading.
86. A drug dispenser according to any of claims 60 to 85, wherein the actuation counter includes a counter housing, which houses some or all of the other elements of the actuation counter.
87. A drug dispenser according to claim 86, wherein said counter housing is defined at least in part by the housing of the drug dispenser.
88. A drug dispenser according to either of claim 86 or 87, wherein the counter housing is shaped to define the first axis of rotation and the second axis of rotation.
89. A drug dispenser according to claim 88, wherein the first count wheel mounts to the housing for rotation about the first axis of rotation and the kick wheel mounts to the housing for rotation about the second axis of rotation.
90. A drug dispenser according to any of claims 87 to 89, wherein the counter housing takes the form of a bezel.
91. A drug dispenser according to any of claims 87 to 90, wherein the counter housing includes a viewing window through which the count may be viewed.
92. A drug dispenser according to claim 91, wherein the actuation counter has a shutter to close off the viewing window at a predetermined point in the actuation counter operation.
93. A drug dispenser according to any of claims 60 to 92, wherein the first and second count wheels are adapted in use to rotate in the same sense about the first axis.
94. A drug dispenser according to any of claims 60 to 93, wherein the actuation counter has a display region through which the first and second count wheels are rotatable and a/the shutter which is movable to a shuttering position in which it shutters the display region.
95. A drug dispenser according to claim 94, wherein the actuation counter is so configured and arranged that the shutter is only movable to the shuttering position when the first and second count wheels are in predetermined angular positions about the first axis.
96. A drug dispenser according to either of claim 94 or 95, wherein the actuation counter is configured and arranged so that the shutter is only able to be moved to the shuttering position when the first count wheel has rotated through a plurality of revolutions about the first axis.
97. A drug dispenser according to any of claims 94 to 96, wherein the actuation counter is configured and arranged such that the shutter moves to its shuttering position in response to movement of at least one of the count wheels.
98. A drug dispenser according to any one of claims 94 to 97, wherein the shutter is moved to its shuttering position by the at least one count wheel.
99. A drug dispenser according to claim 98, wherein the shutter is carried to the shuttering position by the at least one count wheel.
100. A drug dispenser according to any of claims 97 to 99, wherein the at least one count wheel is the second count wheel.
101. A drug dispenser according to any of claims 97 to 100, wherein the at least one count wheel and the shutter have cooperating parts through which, in use, the at least one count wheel moves the shutter to its shuttering position.
102. A drug dispenser according to any of claims 94 to 101, wherein the actuation counter is configured and arranged to display a count sequence with the count wheels and to cause the shutter to move to its shuttering position at the end of the count sequence.
103. A drug dispenser according to any one of claims 92 and 94 to 102, wherein the shutter is comprised in one of the count wheels.
104. A drug dispenser according to claim 103, wherein the count wheel is integrally formed with the shutter.
105. A drug dispenser according to either of claim 103 or 104, wherein the shutter overlies the other count wheel.
106. A drug dispenser according to any of claims 103 to 105, wherein the shutter is comprised in the second count wheel.
107. A drug dispenser according to any of claims 60 to 106, wherein the actuation counter is configured and arranged to sequence from a count mode of operation, in which the first count wheel is able to drive rotation of the second count wheel through the kick wheel, to a non-count mode of operation, in which the first count wheel is unable to drive rotation of the second count wheel through the kick wheel.
108. A drug dispenser according to claim 107, wherein the actuation counter is configured and arranged to sequence from the count mode to the non-count mode when the first count wheel has completed a predetermined number of revolutions about the first axis.
109. A drug dispenser according to either of claim 107 or 108, wherein the actuation counter is adapted to sequence from the count mode to the non-count mode when the second count wheel is disposed in a predetermined angular orientation about the first axis.
110. A drug dispenser according to any of claims 107 to 109, wherein the actuation counter is configured and arranged such that in the non-count mode meshing of the kick teeth with the index tooth and/or the second count wheel teeth is unable to occur.
111. A drug dispenser according to claim 110, wherein a gap is provided in the set of kick teeth or the second count wheel teeth to disable meshing in the non-count mode.
112. A drug dispenser according to any of claims 60 to 111, wherein the actuation counter is provided with a lock-out mechanism for locking the actuation counter at an end point of its operation.
113. A drug dispenser according to claim 112, wherein the lock-out mechanism is adapted to cause the first count wheel to be locked against rotation.
114. A drug dispenser device according to any of claims 1 to 113, wherein the drug discharge device is suitable for discharging aerosolized drug and comprises an aerosol canister provided with a discharge valve having a valve stem.
115. A drug dispenser device according to claim 114, wherein said valve stem is received within a stem block provided to the housing, which stem block includes a passage that acts such as to channel discharged aerosolized drug from the valve stem to the outlet.
116. A drug dispenser device according to either of claim 114 or 115, wherein the outlet defines a mouthpiece.
117. A drug dispenser device according to any of claims 114 to 116, wherein the aerosol canister comprises an aerosol drug formulation comprising a drug in a propellant.
118. A drug dispenser device according to claim 117, wherein said propellant is a fluorocarbon or hydrogen-containing chlorofluorocarbon propellant.
119. A drug dispenser device according to any of claims 1 to 113, wherein the drug discharge device is suitable for discharging a spray of fluid drug and comprises a fluid container provided with a pump having a discharge tube.
120. A drug dispenser device according to claim 119, wherein said discharge tube is received within a discharge tube block provided to the housing, which discharge tube block includes a passage that acts such as to channel discharged fluid drug from the discharge tube to the outlet.
121. A drug dispenser device according to either of claim 119 or 120, wherein the outlet defines a nozzle.
122. A drug dispenser device according to any of claims 119 to 121, wherein the fluid container comprises a fluid drug formulation comprising a solution of drug in a solvent.
123. A drug dispenser device according to any of claims 119 to 122, wherein the fluid container comprises a fluid drug formulation comprising a suspension of drug in a suspending agent.
124. A drug dispenser device according to any of claims 1 to 123, additionally comprising a drug formulation in the container.
125. A drug dispenser device according to claim 124, wherein the drug of said drug formulation is an anti-inflammatory agent.
126. A drug dispenser device according to claim 125, wherein said anti-inflammatory agent is selected from the group consisting of a corticosteroid, an NSAID, a glucocorticoid compound and mixtures thereof.
127. A drug dispenser device substantially as described herein with reference to the accompanying drawings.
128. A housing assembly for receipt of a drug discharge device, said drug discharge device having a longitudinal axis and comprising a container for storing a drug formulation to be dispensed, a discharge mechanism and a discharge channel extending from said container for discharge of said drug formulation, the housing assembly comprising
(c) a container collar for connection to the drug discharge device;
(d) connecting to said container collar and moveable with respect thereto along the longitudinal axis of the drug discharge device, a transfer element, said transfer element including an actuating portion;
(e) provided to the housing, at least one finger operable member moveable to apply an actuating force to said actuating portion of said transfer element to move the transfer element from an initial transfer element position along the longitudinal axis in a first direction;
(f) provided to the container collar, a pre-load mechanism to prevent transfer of said actuating force to the container collar to move said drug discharge device along the longitudinal in the first direction to actuate the discharge mechanism until a pre-determined threshold force is overcome; and
(g) connecting the container collar with the transfer element, a biasing return mechanism acting to bias the transfer element along the longitudinal axis in a second direction to return the transfer element to the initial transfer element position.
129. A housing assembly for reversible receipt of a drug discharge device substantially as described herein with reference to the accompanying drawings.
US12674063 2007-08-21 2008-08-19 Drug dispenser Active 2030-02-19 US8820318B2 (en)
US95695007 true 2007-08-21 2007-08-21
US12674063 US8820318B2 (en) 2007-08-21 2008-08-19 Drug dispenser
PCT/EP2008/060861 WO2009024578A3 (en) 2007-08-21 2008-08-19 Drug dispenser
US20110061646A1 true true US20110061646A1 (en) 2011-03-17
US8820318B2 US8820318B2 (en) 2014-09-02
ID=39944602
US12674063 Active 2030-02-19 US8820318B2 (en) 2007-08-21 2008-08-19 Drug dispenser
US (1) US8820318B2 (en)
EP (1) EP2197524B1 (en)
ES (1) ES2606977T3 (en)
WO (1) WO2009024578A3 (en)
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EP2197524B1 (en) 2016-09-28 grant
WO2009024578A3 (en) 2009-04-16 application
EP2197524A2 (en) 2010-06-23 application
US8820318B2 (en) 2014-09-02 grant
WO2009024578A2 (en) 2009-02-26 application
ES2606977T3 (en) 2017-03-28 grant
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Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:CROSBY, GARY THOMAS;REEL/FRAME:031534/0505