WO2009086009A1

WO2009086009A1 - Dose counters and containers

Info

Publication number: WO2009086009A1
Application number: PCT/US2008/087526
Authority: WO
Inventors: Keith Herman Bishop; Wayne Phillips
Original assignee: Schering Corporation
Priority date: 2007-12-21
Filing date: 2008-12-18
Publication date: 2009-07-09

Abstract

Various embodiments of the present invention provide dosage counters, such as those useful in dispensers or containers. Suitable dispensers or containers include spray pump containers, metered dose inhalers and the like. Counters may include at least one indicia, including, but not limited to, numbers, colors, markings or words such as days that indicate the number or amount of dosages that have been used or remain in the device.

Description

DOSE COUNTERS AND CONTAINERS

FIELD OF THE INVENTION

The present invention relates generally to dosage counters such as those useful on containers. Particularly useful containers include medicament containing spray pump containers.

BACKGROUND OF THE INVENTION

Nasal delivery is often a preferred method of delivering drugs to a patient. In order to achieve this result, nasal spray containers are known for administering a medication by spraying a fine mist into the nose. A spray container typically contains a predetermined number of doses. However, if there is no indication as to when the contents are nearing depletion, then there is no positive way for a person to determine when to renew their prescription. Thus, it would be desirable to provide a counter or indicator with a nasal spray container.

Another issue as the nasal spray nears depletion is that the doses emitted from the nasal spray container may not contain the full spray amount thereby causing a spray to not contain the correct amount of medication. Thus, it would be desirable for a nasal spray to have a lockout mechanism to prevent under dosing as the container nears depletion.

Further, it would be desirable to have a nasal spray container that provides a visual indication of the amount of doses remaining in the container and/or a lockout mechanism to prevent or lock the spray pump from actuacting thereby reducing the possibility of an underdosing of the medicament. SUMMARY OF THE INVENTION

In accordance with various aspects of the present invention, dosage counters are provided. Counters may include at least one indicator. The counter may indicate the amount of doses remaining or used in a container. The doses may be for a product containing a medicament such as a nasal spray containing an active pharmaceutical agent. The counter may include one or more indicia including, but not limited to, numbers, colors, markings or words such as days, weeks or months that indicate the number or amount of dosages that have been used or remain in the container. Numbers may be used to indicate the number of dosages or days of use that remain or have been used. The counter may also be a gauge where a marking moves as doses are used.

Various embodiments of the present invention provide for dosage counters such as those useful for a spray pump container of the type including, for example, a container with a neck for holding a liquid therein and a pump extending through the neck for delivering doses of the liquid from the container. Dosage counters may include a base mounted on the container around the neck thereof, the base including a display window. Dosage counters may also include a graphic wheel rotatably mounted around the neck and within the base, the graphic wheel having at least one indicator thereon to be displayed through the display window for indicating an amount of doses remaining in the container after delivery of each dose from the container. Dosage counters may also include an actuator connected with the pump and movable in an axial direction of the container for controlling the pump to deliver a dose of the liquid during each axial movement thereof in a direction toward the container, the actuator including a delivery nozzle at a free end thereof for delivering a spray dose of the liquid. Dose counters may also include a mechanism connected between the actuator and the graphic wheel for causing rotation of the graphic wheel by an incremental distance in response to each axial movement of the actuator in a direction toward the container, such that the at least one indicator displays an amount of doses remaining in the container through the display window. The graphic wheel may include a plurality of gear teeth arranged circumferentially therearound, and the mechanism includes at least one drive gear, each drive gear having a plurality of gear teeth adapted to be in meshing engagement with the gear teeth of the graphic wheel.

In several embodiments, the plurality of gear teeth of the graphic wheel are arranged circumferentially on an upper edge thereof, and each drive gear includes an axis which is orthogonal to the axial direction of the container.

The mechanism may further include at least one rack movable by the actuator in the axial direction of the container. At least one rack includes a tooth for engagement with the gear teeth of a respective drive gear for rotating the respective drive gear around the orthogonal axis, which in turn, causes rotation of the graphic wheel.

The base may support each drive gear for rotation around the orthogonal axis, and the base includes at least one guide channel for slidably guiding the at least one rack for movement in the axial direction.

There can be one or two drive gears and the mechanism includes a plunger movable by the actuator in the axial direction of the container. The plunger may include two racks and each rack includes one tooth for engagement with the gear teeth of a respective drive gear for rotating the respective drive gear around the orthogonal axis. A spring normally biases the plunger and the actuator in an axial direction away from the container such that the gear teeth of the drive gears are moved out of engagement with the gear teeth of the graphic wheel. hi accordance with other embodiments of the present invention, the plurality of gear teeth of the graphic wheel are arranged circumferentially at a lower end thereof, and each drive gear includes an axis which is parallel to the axial direction of the container. Each drive gear includes a lower pinion mounted at a lower end of a shaft which is rotatable in the axial direction of the container. Also, an upper pinion is formed at an upper end of each shaft. The mechanism further includes a ring drive gear rotatably mounted on the pump and having gear teeth for meshing with gear teeth of at least one upper pinion.

The latter mechanism may further include an arrangement for converting axial movement of the actuator to rotational movement of the ring drive gear. This arrangement includes a plurality of ramped gear teeth on an upper surface of the ring drive gear, and a ring plunger positioned above the ring drive gear for movement only along the axial direction of the container. The ring plunger has a lower surface with small gear teeth thereon for engagement with the ramped gear teeth, such that each engagement of the small gear teeth with the ramped gear teeth results in rotation of the ring drive gear. A spring normally biases the ring drive gear, the ring plunger and the actuator in an axial direction away from the container such that the gear teeth of the ring drive gear are moved out of engagement with the gear teeth of the at least one upper pinion. A cover covers the base, the graphic wheel, the actuator and the mechanism on the container. The base includes an upper portion with downwardly extending gear teeth for engaging the ramped gear teeth upon movement of the ring drive gear by the spring away from the container and out of engagement with the gear teeth of the at least one upper pinion such that the downwardly extending gear teeth rotate the ring drive gear by an increment to reset the ring drive gear for engagement with the gear teeth of the ring plunger during the next actuation of the actuator.

The at least one indicator of the graphic wheel can take various forms. In one embodiment, the at least one indicator includes a strip on an outer surface of the graphic wheel that reduces in height circumferentially around the graphic wheel. In another embodiment, the at least one indicator of the graphic wheel includes a spiral line on an outer surface of the graphic wheel that moves down circumferentially around the graphic wheel. Pn still another embodiment, the graphic wheel includes a spiral groove therearound, the at least one indicator includes an insert slidably mounted in the spiral groove, and the base includes an arrangement for restraining rotational movement of the insert while permitting axial movement of the insert, such that the insert moves in the axial direction of the container as the graphic wheel is rotated, hi a further embodiment, the at least one indicator includes numerical indicia on an outer surface of the graphic wheel, corresponding to the number of doses remaining in the container.

In another embodiment of the at least one indicator, the graphic wheel includes a spiral groove therearound and numerical indicia on an outer surface of the graphic wheel, corresponding to the number of doses remaining in the container. The at least one indicator includes an insert slidably mounted in the spiral groove, the insert including an opening therein for displaying one of the numerical indicia therethrough in dependence on the rotational position of the graphic wheel. The base includes an arrangement for restraining rotational movement of the insert while permitting axial movement of the insert, such that the insert moves in the axial direction of the container as the graphic wheel is rotated.

Other embodiments provide drug products including at least one medicament in a solution or suspension located in a container; wherein the container has a dosage counter with at least one indicator for indicating an amount of doses of medicament. The container may also have at least one lock-out mechanism to prevent the medicament from being dispensed from the container when the counter indicates a predetermined amount of doses. The product may be a nasal spray that includes at least one medicament, such as an active pharmaceutical agent. Other embodiments provide for products useful to minimize or prevent the use or administration of subpotent doses of a medicament contained in a nasal spray container. Such products can include a dosage counter and at least one locking mechanism that prevents the nasal spray from actuating when the dosage counter indicates a predetermined amount. The nasal spray container may be free of propellants. The pre- determined amount may be an amount greater than the start of when subpotent doses of a medicament might be released from the nasal spray. In this situation, the spray will be prevented from actuating before the sub-potent doses can be released.

The counter may include at least one display window and at least one graphic wheel which has at least one indicator thereon to be displayed through at least one display window for indicating an amount of doses.

The container may have a pump for delivering doses of the medicament from the container and the dosage counter may include at least one graphic device having at least one indicator thereon to be displayed through the at least one display area; an actuator connected with the pump and movable for controlling the pump to deliver a dose of the liquid during each movement thereof, the actuator including a delivery nozzle for delivering a spray dose of the liquid; and a mechanism connected between the actuator and the at least graphic device for causing movement of the at least one graphic device by an incremental distance in response to each movement of the actuator, such that the at least one indicator is visible through the at least one display area.

Various embodiments provide for containers including a liquid therein and a pump for delivering doses of the liquid from the container and a dosage counter. The dosage counter can include at least one graphic device having at least one indicator thereon to be displayed through the at least one display area; an actuator connected with the pump and movable for controlling the pump to deliver a dose of the liquid during each movement thereof, the actuator including a delivery nozzle for delivering a spray dose of the liquid; and a mechanism connected between the actuator and the at least one graphic device for causing movement of the at least one graphic device by an incremental distance in response to each movement of the actuator, such that the at least one indicator is visible through the at least one display area.

Still further embodiments provide for dosage counters useful for a spray pump container that has a neck for holding a liquid therein and a pump extending through the neck for delivering doses of the liquid from the container. The dosage counter may include a base mounted on the container around the neck thereof, the base including at least one display area; at least one graphic wheel rotatably mounted around the neck and within the base, the at least one graphic wheel having at least one indicator thereon to be displayed through the at least one display area for indicating an amount of doses; an actuator connected with the pump, the actuator including a delivery nozzle for delivering a dose of the liquid; and a mechanism connected between the actuator and the at least one graphic wheel for causing rotation of the at least one graphic wheel by an incremental distance in response to each movement of the actuator, such that the at least one indicator displays an amount of doses in the at least one display area. The container may include at least one lock out mechanism that prevents actuation of the pump when the graphic device indicates a predetermined amount. The at least one lock out mechanism may be triggered when the graphic device indicates that no doses are remaining or the maximum amount of doses has been reached. The container may consist of two lock out mechanisms. The at least one lock out mechanism may be designed to stop the graphic device from moving which prevents the pump from being depressed which prevents the nasal spray from being used.

Other embodiments provide for a package including a drug product with at least one medicament located in a container; and instructions for using said medicament; wherein the container has at least one dosage counter for indicating an amount of doses remaining or used. The predetermined amount herein, may indicate that no doses remain, e.g. 0, or that the total amount of doses has been reached or the amount of usage days has been reached. The product may be a nasal spray, metered dose inhaler or dry powder inhaler.

Further embodiments provide for methods of determining the amount of doses remaining or used of a nasal spray including the steps of utilizing a dosage counter of the present invention.

Additional embodiments provide for methods of preventing the use or administration of subpotent doses of a medicament contained in a nasal spray container including the step of locking a metered release mechanism when a dosage counter indicates a pre-determined amount which is before the subpotent doses are released from the nasal spray. The subpotent doses may be either short-filled or incompletely filled. The indicator may indicate a number of doses used or left in the container or may be a gauge showing the amount of doses used or left in the container.

Various embodiments of the present invention provide dosage counters for dispensers such as those that may be useful in delivering medicaments in various forms such as sprays, solutions, suspensions, gels, ointments, and the like. The dosage counter may be provided on any suitable device such as a container, nasal spray, such as sprays with or without a propellant, a metered dose inhaler, with and with a propellant, dry powder inhaler or a tablet type package. The above and other features of the invention will become readily apparent from the following detailed description thereof which is to be read in connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a perspective view of a nasal spray pump container with a dosage indicator according to a first embodiment of the present invention;

Fig. 2 is a perspective view of the bottle of the nasal spray pump container;

Fig. 3 is a perspective view of the pump of the nasal spray pump container;

Fig. 3 A is a longitudinal cross-section of the pump; Fig. 4 is a top perspective view of the base of the dosage indicator;

Fig. 5 is a bottom perspective view of the base of the dosage indicator;

Fig. 6 is a front elevational view of the base of the dosage indicator;

Fig. 7 is a perspective view of the cylindrical graphic gear wheel of the dosage indicator; Fig. 8 is a top perspective view of the cover of the dosage indicator; Fig. 9 is a bottom perspective view of the cover of the dosage indicator; Fig. 10 is a top plan view of the cover of the dosage indicator; Fig. 11 is a perspective view of the gear of the dosage indicator; Fig. 12 is a top perspective view of the plunger of the dosage indicator;

Fig. 13 is a bottom perspective view of an alternative embodiment of the plunger of the dosage indicator;

Fig. 14 is a top perspective view of the actuator of the nasal spray pump container; Fig. 15 is a bottom perspective view of the actuator of the nasal spray pump container;

Fig. 16 is a longitudinal cross-sectional view of the actuator of the nasal spray pump container;

Fig. 17 is a perspective view of the cap of the nasal spray pump container; Fig. 18 is a longitudinal sectional view of the nasal spray pump container with the dosage indicator of Fig. 1, along the longer transverse axis thereof;

Fig. 19 is a longitudinal sectional view of the nasal spray pump container with the dosage indicator of Fig. 1, along the shorter transverse axis thereof;

Fig. 20 is an assembled perspective view of the dosage indicator; Fig. 21 is a blown-apart perspective view of the dosage indicator;

Fig. 22 is an enlarged, partially broken away, perspective view showing the dosage indicator assembled with the nasal spray pump container; Fig. 23 is an enlarged, partially broken away, perspective view similar to Fig. 22, showing the dosage indicator assembled with the nasal spray pump container, but with the pump and coil spring removed;

Fig. 24 is a front elevational view showing the dosage indicator assembled with the nasal spray pump container;

Fig. 25 is an elevational view of a graphic gear wheel according to another embodiment of the present invention;

Fig. 26 is a perspective view of a graphic gear wheel according to still another embodiment of the present invention; Fig. 27 is a front perspective view of a display insert for use with graphic gear wheel of Fig. 26;

Fig. 28 is a rear perspective view of the display insert of Fig. 27;

Fig. 29 is a perspective view of a nasal spray pump container with a dosage indicator according to a second embodiment of the present invention; Fig. 30 is a perspective view of the bottle of the nasal spray pump container;

Fig. 31 is a perspective view showing the dosage indicator of the second embodiment assembled with the nasal spray pump container, but with the actuator removed;

Fig. 32 is a blow apart, perspective view of the dosage indicator and nasal spray pump container of Fig. 31 ;

Fig. 33 is a perspective view of the two half-cylindrical walls that form the cylindrical graphic gear wheel;

Fig. 34 is a perspective view of the two thin diametrically opposite, part oval side walls that form the base; Fig. 35 is a perspective view of one pinion drive;

Fig. 36 is a top perspective view of the ring drive gear;

Fig. 37 is a bottom perspective view of the ring drive gear;

Fig. 38 is a bottom perspective view of the ring plunger; Fig. 39 is a top, front perspective view of the cover;

Fig. 40 is a bottom perspective view of the cover;

Fig. 41 is a top plan view of the cover;

Fig. 42 is a top perspective view of the actuator of the nasal spray pump container of the second embodiment; Fig. 43 is a bottom perspective view of the actuator of the nasal spray pump container of Fig. 42;

Fig. 44 is a perspective view of a nasal spray pump container with a dosage indicator according to a modification of the first embodiment of the present invention; and Fig. 45 is a perspective view of the bottle of the nasal spray pump container of

Fig.44.

DETAILED DESCRIPTION

Referring to the drawings in detail, and initially to Fig. 1 thereof, various embodiments of the present invention are specially adapted for use with current nasal spray pump containers. Advantageously, various embodiments of the present invention fit or substantially fit within the existing real estate of available nasal spray containers with no or minimal changes to the existing containers. Thus, various embodiments of the present invention minimize the risks or costs associated with changing or switching to new nasal spray containers or re-validating such containers. Additionally, various embodiments of the present invention include one or more lock out mechanisms. Advantageously, lock out mechanisms can prevent the last part of the medicament from being used, which may or may not include a full dose of the active pharmaceutical agent.

Nasal spray pump container 10 includes a bottle 12, shown best in Fig. 2, having a side wall 14 of a generally oval transverse cross-sectional configuration, a top closing wall 16 and a bottom closing wall 18. An opening 20 is formed centrally in top closing wall 16 and an elongated hollow cylindrical neck 22 extends upwardly from top closing wall 16 in surrounding relation to and in open communication with opening 20. An outwardly extending annular lip 24 is formed at the upper end of hollow cylindrical neck 22. In addition, a raised annular shoulder 26 of a small height is formed on the upper surface of top closing wall 16 in surrounding relation to hollow cylindrical neck 22, includes two diametrically opposite, outwardly extending, arcuate flanges 28 at the upper end of shoulder 26, each flange extending for an arcuate angle of about eighty degrees. A pump 30 is positioned within hollow cylindrical neck 22 for pumping out the liquid in bottle 12 as a spray. Specifically, as shown in Figs. 3 and 3A, pump 30 includes a main cylindrical body 32 that fits within hollow cylindrical neck 22 and a larger diameter cylindrical support 34 at the upper end of main cylindrical body 32. Larger diameter cylindrical support 34 rests on the upper surface of outwardly extending annular lip 24. A reduced diameter annular shoulder 36 extends upwardly from the upper surface of larger diameter cylindrical support 34 and a small diameter upper pump stem 38 extends through the upper surface of annular shoulder 36 for slidable movement therein. A small diameter lower dip tube 40 extends down from the lower surface of main cylindrical body 32, such that the lower end thereof is positioned close to bottom closing wall 18. Main cylindrical body 32, larger diameter cylindrical support 34, reduced diameter annular shoulder 36, small diameter upper tube 38 and small diameter lower tube 40 are all coaxially aligned.

A spring supported clapper door 31 seats within main cylindrical body 32 on the lower wall thereof above dip tube 40 and functions as a valve to only permit liquid to flow in one direction from bottle 12 to the chamber 33 within main cylindrical body 32. A piston 35 is slidably positioned in the upper end of chamber 33 and is normally biased upwardly by a return spring 37. Piston 35 has a through bore 35a for slidably receiving the lower end of pump stem 38. Pump stem 38 includes an annular flange 38a at the upper end of main cylindrical body 32 and which is normally biased upwardly by a stem spring 39 which is weaker than return spring 37. Pump stem 38 also includes a through bore 38b which opens at a side opening 38c near the lower end thereof. Side opening 38c is normally blocked by piston 35, as shown in Fig. 3A. However, when pump stem 38 is pushed down against the force of stem spring 39, side opening 38c travels past the lower end of piston 35 and is in open communication with chamber 33. There is also a one way clapper valve (not shown) at the upper end of pump stem 38. There are small openings 41 in the side wall of main cylindrical body 32 which defines chamber 33. At the start of operation, it may be desirable to prime pump 30. A counter or indicator may be situated to allow for about 1 to about 10 or about 3 to about 7 or 4, 5 or 6 priming pumps before the indicia begin to move. Therefore, pump stem 38 is pushed down a few times. As a result, pump stem 38 moves down in chamber 33 against the force of stem spring 39, and piston 35 also moves down in chamber 33 against the force of return spring 37. This serves to expel any air from chamber 33 into bottle 12 through small openings 41. This also results in liquid entering chamber 33 through dip tube 40 to replace the expelled air. When sufficient liquid fills chamber 33, which will occur after a few pumping movements of pump stem 38, pump 30 will be primed. Thereafter, when pump stem 38 is again pushed down, it slides down within piston 35 until side opening 38b is in communication with chamber 33. Continued movement results in pump stem 38 bottoming out in piston 35, which results in piston 35 also moving down within chamber 33 against the force of return spring 37. This results in the liquid within chamber 33 being forced out through pump stem 38 to deliver a dose of liquid to the person operating nasal spray pump container 10. When the pressure on pump stem 38 is released, springs 37 and 39 force piston 35 and pump stem 38 back to their inoperative positions shown in Fig. 3 A.

It will be appreciated that the any suitable bottle and pump may be used and the present invention is not limited by the particular shape of bottle 12 and the particular pump 30 as shown in the figures. In accordance with the present invention, a dosage indicator 42 is provided for use with nasal spray pump container 10 and pump 30. Specifically, dosage indicator 42 includes a base 44 which removably locks onto raised annular shoulder 26 of bottle 12. Base 44 includes a thin side wall 46 of a generally oval shape and having an outwardly extending flange 48 of a generally L-shaped cross-section at the lower end thereof. A lower closing wall 50 at the lower end of side wall 46 includes a central circular opening 52 having inwardly extending, diametrically opposite, arcuate flanges 54. In this manner, base 44 can be assembled with bottle 10 by positioning base 44 over cylindrical neck 22 until arcuate flanges 54 are positioned in the spaces between arcuate flanges 28, and then rotating base 44 until arcuate flanges 54 are positioned beneath arcuate flanges 28, in a Luer lock manner. In this position, outwardly extending flange 48 rests on the upper surface of top closing wall 16.

Base 44 further includes two diametrically opposite arcuate, thin tower walls 56 along the longer diametrical axis of the generally oval shape of side wall 46. Each arcuate tower wall 56 extends for an arcuate distance of about forty-five degrees, and has an elongated central slot or recess 58 extending in the axial direction of base 44 and which is open at the upper end thereof. Two diametrically opposite guide wall enclosures 60 extend axially along the inner surface of side wall 46 in alignment with one side of each tower wall 56 and extend for a distance from lower closing wall 50 to just short of the upper edge of thin side wall 46, each having an axially extending guide channel 61 defined therein. Four rectangular openings 62 are also equiangularly formed at the same height in side wall 46 at a height equal to about one-third the height of side wall 46, measured from the upper edge thereof. A larger display window opening 64 is also formed at the lower end of side wall 46 along the shorter diametrical axis of the generally oval shape of side wall 46. Opening 64 can be covered by a transparent plate. Alternatively, opening 64 can be closed and be formed as a single molded piece with thin side wall 46 of base 44, but be of transparent so as to provide a viewable window. Lastly, the upper edge of each side wall 46 between tower walls 56 is formed with a shallow, elongated recess 66.

As shown in Fig. 7, a cylindrical graphic gear wheel 68 is positioned within base 44 such that the lower edge thereof seats within central circular opening 52 of base 44 and the upper edge extends upwardly slightly above the upper edge of side wall 46 of base 44. The upper edge of gear wheel 68 has a plurality of small gear teeth 70 thereon, corresponding in number to the number of doses in bottle 12 plus a few extra doses to enable priming of pump 30. Thus, although the present invention shows forty- seven gear teeth 70, the present invention is not limited thereby, and there may be, for example, two hundred teeth. hi addition, a shallow recess 72 extends around a large part of the circumference, for example, for about three hundred degrees, on the outer surface of gear wheel 68. While the upper edge 74 of shallow recess 72 extends along a circular path around gear wheel 68 at a predetermined height which is about two-fifths from the bottom edge thereof, the lower edge 76 of shallow recess 72 moves down in a spiral path from a high start position to a low end position. A display insert 78 is inset into shallow recess 72. Display insert 78 may be provided with a different color than the remainder of gear wheel 68. In this manner, as will be understood better from the description hereafter, as gear wheel 68 is caused to rotate the distance of one gear tooth 70, the lower edge 76 of shallow recess 72 of display insert 78 appears to move down, as viewed through larger display window opening 64, thereby providing a visual indication to the user as to the number of doses remaining.

As shown best in Figs. 8-10, a cover 80 is formed by a generally annular body 82 formed by a thin upper annular wall 84, an outer, downwardly extending, thin circular side wall 86 connected to an outer edge of upper annular wall 84 and an inner, downwardly extending, thin circular side wall 88 connected to an inner edge of upper annular wall 84. The height of outer, downwardly extending, circular side wall 86 is about twice the height of inner downwardly extending, circular side wall 88.

There are four legs 92 extending down from outer, downwardly extending, circular side wall 86. Each leg 92 is formed by a first leg section 94 that is coplanar with outer, downwardly extending, circular side wall 86 and extends down therefrom, and a second outwardly extending leg section 96 that is substantially transverse to and connected to one side edge of first leg section 94. Each leg 92 has an outwardly extending tab 98 at the lower end thereof. Because legs 92 are slightly resilient, they can be moved slightly by an external force, whereby tabs 98 are able to moved inwardly along the inner surface of thin side wall 46 of base 44 and then snap out and engage within rectangular openings 62 of base 44 to lock cover 80 to base 44.

Diametrically opposite, outwardly extending, part oval flange walls 100 extend from the lower edge of outer, downwardly extending, circular side wall 86, each flange wall 100 having the same shape and dimensions as shallow, elongated recesses 66 of base 44 for seating therein when cover 80 is locked to base 44.

Two diametrically opposed tower sections 102 are formed on annular body 82 between adjacent legs 92 and are positioned essentially ninety degrees out of phase from outwardly extending flange walls 100. Each tower section 102 includes an upward side wall extension 104 of inner downwardly extending, circular side wall 88, each extension 104 extending in the circumferential direction for an arcuate angle of about forty-five degrees and extending in an axial direction of cover 80 to a position above the upper edge of side wall 46 of base 44. Each tower section 102 further includes side wall extensions 106 which are formed by extending second outwardly extending leg sections 96 in an axial direction of cover 80 to a position above the upper edge of side wall 46 of base 44 and also with a right angle section connected to and positioned on and above upper annular wall 90. The upper edges of upward side wall extension 104 and side wall extensions 106 extend to the same height and are therefore coplanar with each other. A thin plateau wall 108 is connected with the upper edges of the respective upward side wall extension 104 and side wall extensions 106, and extends radially outward of the outer edges of side wall extensions 106 so as to present an overhanging arcuate lip 110. When cover 80 is connected with base 44, overhanging arcuate lips 110 seat on the upper edges of tower walls 56 of base 44. Each tower section 102 further includes an axially extending guide wall enclosure 112 connected to the inner surface of a respective second outwardly extending leg section 96 and to the outer surface of outer, downwardly extending, circular side wall 86, and having an axially extending guide channel 114 therein. When cover 80 is assembled with base 44, guide channel 1 14 is in axial alignment with guide channel 61 of base 44.

Further, an arcuate wall 1 16 which extends over an arc of about 135 degrees, extends down from the underside of plateau wall 108 at a position spaced from the respective other second outwardly extending leg section 96 to a lower end of an inner side wall 118 of the respective axially extending guide wall enclosure 112, thereby defining an oval shaped opening 120 between plateau wall 108, the inner side wall 118 of the respective axially extending guide wall enclosure 112 and arcuate wall 116, with the longer axis of oval shaped opening 120 extending in the axial direction of cover 80. Further, inner side wall 118 of each axially extending guide wall enclosure 112 includes an elongated vertical opening 122 which provides communication between axially extending guide channel 114 and oval opening 120.

In addition, each upward side wall extension 104 includes an elongated central slot or recess 124 extending in the axial direction thereof and which is open at the upper end thereof. Recess 124 is in radial alignment with oval opening 120 and also with the respective recess 58 of base 44 when cover 80 is assembled with base 44.

Two identical gears 126 are provided, each gear 126, as shown in Fig. 11, being formed by a central cylindrical body 128 having a plurality of gear teeth 130 spaced circumferentially therearound and extending in the axial direction of central cylindrical body 128. However, the length of each gear tooth 130 is less than the length of central cylindrical body 128 and is centered along the length thereof, whereby opposite ends of central cylindrical body 128 define two axle stubs 132 and 134 which rotatably seat in respective recesses 58 and 124 and with gear teeth 130 being rotatably positioned in the associated oval opening 120.

It will be appreciated that, because recess 58 is elongated in the axial direction of base 44, recess 124 is elongated in the axial direction of cover 80, and opening 120 is oval shaped, gears 126 can move a small distance in the axial direction of base 44. hi their lowermost positions, when axle stubs 132 and 134 are supported at the lower closed walls of recesses 58 and 124, gear teeth 130 are engaged with gear teeth 70 of graphic gear wheel 68. Thus, as gears 126 are rotated by one gear tooth 130, as will be described hereafter, the meshing of gear teeth 130 with gear teeth 70 causes graphic gear wheel 68 to rotate by an angular distance equal to one gear tooth 70.

In order to rotate gears 126, a plunger 136 is provided, as shown in Figs. 12 and 13, which includes an oval plate 138 having a central opening 140 therein, and an annular boss 142 in surrounding relation to central opening 140 and extending axially from the upper surface of oval plate 138. A small inwardly turned annular lip 143 is formed at the open upper end of annular boss 142. Two elongated racks 144 extend axially from opposite ends of the lower surface of oval plate 138 and are positioned along the longer diametrical axis thereof. Each rack 144 has the general shape of guide channels 61 and 114 for sliding therein. In various embodiments, as shown in Fig. 12, a recess 146 extends along one edge of one rack 114 for about one-third of the length thereof and near the upper end thereof. A single tooth 148 extends centrally out from recess 146. When racks 144 are slidably positioned in channels 61 and 114, tooth 148 extends through the respective elongated vertical opening 122 and into engagement with the gear teeth 130 of the respective gear 126. Thus, each time that plunger 136 is moved down, racks 144 move down within channels 61 and 114, whereby the respective gear 126 rotates graphic gear wheel 68 by one gear tooth 70. As a result, a wider portion of display insert 78 is displayed through display window opening 64, thereby indicating that there are less doses in bottle 12. This continues for each dose that is delivered until all doses have been dispensed, and the entire display window opening 64 is filled with display insert 78.

As in alternative embodiments, as shown in Fig. 13, a recess 146 extends along one edge of each rack 114 for about one-third of the length thereof and near the upper end thereof. Recesses 146 of the two racks 144 face in opposite directions from each other. A single tooth 148 extends centrally out from each recess 146. When racks 144 are slidably positioned in channels 61 and 114, teeth 148 extend through elongated vertical opening 122 and into engagement with gear teeth 130 of gears 126. Thus, each time that plunger 136 is moved down, racks 144 move down within channels 61 and 114, whereby gears 126 rotate graphic gear wheel 68 by one gear tooth 70.

A coil spring 150 is positioned between the upper surface of reduced diameter annular shoulder 36 of pump 30 and inwardly turned annular lip 143 of plunger 136 for normally biasing plunger 136 upwardly. When plunger 136 travels downwardly, axle stubs 132 and 134 of gears 126 are rotatably seated at the bottom wall of respective recesses 58 and 124, so that this downward travel causes teeth 148 of racks 144 to engage and rotate gears 126, causing graphic gear wheel 68 to rotate by one gear tooth. However, because recesses 58 and 124 are open at their upper ends so that gears 126 are not restrained in upward movement, movement of plunger 136 upwardly by coil spring 150 causes teeth 148 of racks 144 to engage gear teeth 130 and move gears 126 slightly upwardly out of engagement with teeth 70 of gear wheel 68. In this manner, graphic gear wheel 68 does not rotate in the reverse direction.

As shown in Figs. 14-16, an actuator 152 is mounted on plunger 136 for biasing plunger 136 down against the force of coil spring 150. Actuator 152 includes a lower thin oval shaped wall 154 that fits around the entire assembly including base 44, an upper frusto-conical nozzle wall 156 that is closed at its upper narrow diameter end by a closure wall 158 and has a very small opening 160 therein, and an annular oval shaped connecting wall 162 that connects the lower end of frusto-conical nozzle wall 156 and the upper end of lower cylindrical wall 154 and which also sits on top of oval plate 138 of plunger 136. A tube 164 is connected to the undersurface of closure wall 158 in surrounding relation to small opening 160 therein and extends axially down to the position of annular connecting wall 162, but is spaced therefrom. Tube 164 frictionally fits over small diameter upper pump stem 38 of pump 30 and is thereby fixed thereto, within the confines of coil spring 150. As shown in Fig. 17, a cap 166 is provided for covering dosage indicator 42 when not in use, with the lower end of cap 166 seating with a slight friction fit around top closing wall 16 of bottle 12.

In operation, and referring to Figs. 18-24, after pump 30 has been primed, a person may tilt his or her head forward slightly and inserts the upper end of nozzle wall 156 of actuator 152 in an upright position into the nose. With the person's thumb supporting the bottom of bottle 12, the index and middle finger of the same hand press down on annular connecting wall 162 of actuator 152. Since tube 164 of actuator 152 is fixed to upper pump stem 38 of pump 30, this results in upper pump stem 38 sliding down within piston 35 until side opening 38b is in communication with chamber 33. Continued movement results in pump stem 38 bottoming out in piston 35, which results in piston 35 also moving down within chamber 33 against the force of return spring 37. This results in the liquid within chamber 33 being forced out through pump stem 38 to deliver a dose of liquid to the person operating nasal spray pump container 10.

During the downward travel of actuator 152, plunger 136 is also moved down by annular oval shaped connecting wall 162 engaging oval plate 138 of plunger 136. As a result, teeth 148 of racks 144 rotate gears 126, which in turn, rotate graphic gear wheel 68 by one gear tooth 70, whereby a wider portion of display insert 78 is displayed through display window opening 64, thereby indicating that there are less doses in bottle 12. When the person releases the pressure on actuator 152, coil spring 150 moves plunger 136 upward, and applicator 152 moves upward with plunger 136. At this time, springs 37 and 39 force piston 35 and pump stem 38 back to their inoperative positions shown in Fig. 3 A. At the same lime, because recesses 58 and 124 are open at their upper ends so that gears 126 are not restrained in upward movement, movement of plunger 136 upwardly by coil spring 150 causes teeth 148 of racks 144 to engage gear teeth 130 and move gears 126 slightly upwardly out of engagement with teeth 70 of gear wheel 68. Tn this manner, graphic gear wheel 68 does not rotate in the reverse direction. It will therefore be appreciated that a simple construction is provided for displaying the amount of medication available for delivery in bottle 12.

It will be appreciated that various modifications can be made to the present invention within the scope of the claims. For example, in place of shallow recess 72 on graphic gear wheel 68 and display insert 78 for use therein, an area equivalent to that of display insert 78 can merely be printed on the outer surface of graphic gear wheel 68. Alternatively, as shown in Fig. 25, in a modified cylindrical graphic gear wheel 68', rather than display insert 78 and the large area of shallow recess 72 being provided, a single spiral etched line 76' corresponding to the lower edge 76 of shallow recess 72 can be provided therein, which moves down, as viewed through display window opening 64 as graphic gear wheel 68' is rotated.

As a further alternative, display insert 78 can include indicia markings, such as the number of doses remaining, along an area adjacent to lower edge 76. In this case, as gear wheel 68 is caused to rotate the distance of one gear tooth 70, different indicia are viewed through larger display window opening 64, thereby providing a visual indication to the user as to the number of doses remaining.

As a further alternative, as shown in Figs. 26-28, a graphic gear wheel 68" can be provided in place of graphic gear wheel 68. Graphic gear wheel 68" includes a spiral groove 76" therearound. A rectangular arcuate display insert 78", which may be of a different color than graphic gear wheel 68", includes a rectangular projection 79" at a front face thereof which fits within display window opening 64 of base 44 for movement only in the axial direction of base 44 and which restrains arcuate display insert 78" in display window opening 64. The rear face of arcuate display insert 78" includes a plurality of circumferentially oriented projections 81" that slidably fit within spiral groove 76". Thus, as graphic gear wheel 68" is rotated, projections 81" ride within spiral groove 76". Because arcuate display insert 78" is restrained for movement only in the axial direction of base 44, arcuate display insert 78" moves down within display window opening 64 of base 44 when each dose is dispensed. As an alternative, as shown by dashed lines in Fig. 27, rather than the entire rectangular projection 79" being transparent, only a small window portion 79a" of rectangular projection 79" can be transparent, while the remainder 79b" of rectangular projection 79" can be opaque, so that the display of the doses remaining can be viewed only through small window portion 79a". As an alternative, indicia as to the doses remaining can be formed on the transparent window 64 and/or on side wall 46 of base 44 adjacent to window 64, with an indicator such as a spiral line or the like provided on graphic gear wheel 68. With this arrangement, the indicator on graphic gear wheel 68 will point to or be adjacent to dosage indicator on the transparent window 64 and/or on side wall 46 of base 44 adjacent to window 64. For example, five hash marks 64a can be provided on side wall 46 of base 44 adjacent to window 64, as shown in Fig. 1, or even *on the transparent window 64.

Referring now to Figs. 29-43, a nasal spray pump container 210 and a dosage indicator 242 for use therewith according to other embodiments of the present invention will now be described in which elements corresponding to those of nasal spray pump container 10 and dosage indicator 42 of Figs. 1 -28 are identified by the same reference numerals, but augmented by 200.

Nasal spray pump container 210 includes a bottle 212, shown in Fig. 30, which is essentially identical to bottle 12, that is, with the same elements and arrangement of elements of a side wall 214, a top closing wall 216, a bottom closing wall 218, an opening 220 in top closing wall 216, an elongated hollow cylindrical neck 222, and an outwardly extending annular lip 224 at the top of elongated hollow cylindrical neck 222, a raised annular shoulder 226 and arcuate flanges 228, except that there are four arcuate flanges 228. Pump 230, shown in Figs. 31 and 32, is identical to pump 30, and thereby includes the same elements and arrangement of elements so that a detailed discussion thereof is not provided herein.

In accordance with the present invention, dosage indicator 242 is provided for use with nasal spray pump container 210 and pump 230. Specifically, as shown in Figs. 31 -33, dosage indicator 242 includes a cylindrical graphic gear wheel 268 rotatably positioned around elongated hollow cylindrical neck 222 such that the lower edge thereof seats on raised annular shoulder 226 and the upper edge extends upwardly to a position slightly spaced below outwardly extending annular lip 224 of bottle 212. As shown in Fig. 33, cylindrical graphic gear wheel 268 may be formed by two half- cylindrical walls 268a and 268b which are joined together around elongated hollow cylindrical neck 222 by pins 268c in one end face of each half-cylindrical wall 268a and 268b and which fit within openings 268d in the other end face of the other half- cylindrical wall 268a and 268b. The lower edge of gear wheel 268 has a plurality of small gear teeth 270 thereon, corresponding in number to the number of doses in bottle 212 plus a few extra doses to enable priming of pump 230. In addition, a plurality of numerical indicia 269 are printed circumferentially along the outer surface of gear wheel 268, starting from the number of doses initially in bottle 212, for example, 120 doses, and ending at zero. A different color strip 271 can also be provided at the zero mark to provide a clear indication that no doses remain.

As shown best in Figs. 31, 32 and 34, a base 244 which is secured to raised annular shoulder 226, and more particularly, beneath arcuate flanges 228, is formed by two thin diametrically opposite, arcuate side walls 246a and 246b, each mounted on a lower, half oval base wall 247a and 247b, respectively. Each base wall 247a and 247b includes undercut areas 253 which are adapted to engage beneath arcuate flanges 228 of bottle 212 to lock base 244 to bottle 212. Upper, half oval, inner shelf walls 249a and 249b are connected, respectively, to inner surfaces of arcuate side walls 246a and 246b, and located about one-third of the height of arcuate side walls 246a and 246b, measured from the upper edges thereof. Each inner shelf wall 249a and 249b has a downwardly extending external skirt wall 251a and 251b, respectively. One end face of each base wall 247a and 247b is provided with a pin 255 that fits within an opening 257 in the other end face of the other base wall, and one end face of each inner shelf wall 249a and 249b is provided with a pin 255 that fits within an opening 257 in the other end face of the other inner shelf wall, in order to secure arcuate side walls 246a and 246b together. In this manner, as shown in Fig. 31, a large opening 262 is defined between inner shelf walls 249a and 249b at its upper end, base walls 247a and 247b at its lower end, and free side edges of side walls 246a and 246b at its sides. Numerical indicia 269 are exposed through large opening 262.

In addition, the portions of arcuate side walls 246a and 246b extending above inner shelf walls 249a and 24b are cut away to define a central axially extending spring finger 259 having an outwardly directed tab 263 at the upper ends thereof, the purpose for which will become apparent from the discussion hereafter. Lastly, each inner shelf wall 249a and 249b includes a central opening 265, a guide channel 261 formed axially along the inner surface of arcuate side wall 246a and 246b below opening 265 and a small circular recess 267 in the upper surface of half oval base wall 247a and 247b which is in axial alignment with opening 265.

Two identical pinion drives may be provided 326, as shown in Figs. 31, 32 and 35, being formed by an elongated shaft 328 having an enlarged head 329 with gear teeth 331 spaced circumferentially therearound. Each pinion drive 326 further includes a plurality of gear teeth 330 spaced circumferentially therearound at the lower end thereof for engagement with small gear teeth 270 at the lower end of graphic gear wheel 268. A small diameter pin 333 extends axially down at the lower end of elongated shaft 328. In this regard, each elongated shaft 328 fits through a central opening 265 of a respective inner shelf wall 249a and 249b until small diameter pins 333 are rotated seated in a small circular recess 267 of a respective half oval base wall 247a and 247b. In this manner, as pinion drives 326 are rotated, this causes cylindrical graphic gear wheel 268 to rotate in order to display a different numerical indicia 269 through large opening 262.

As shown in Fig. 32, a coil spring 350 is positioned on top of larger diameter cylindrical support 234 of pump 230 and in surrounding relation to reduced diameter annular shoulder 236.

As shown in Figs. 31 , 32, 36 and 37, a ring drive gear 368 is mounted on top of coil spring 350 and in surrounding relation to reduced diameter annular shoulder 236. Ring drive gear 368 includes a lower annular body 370 a lower set of circumferentially arranged gear teeth 372 provided on the outer surface of lower annular body 370 for engaging gear teeth 331 on enlarged head 329 of gear screws 326. Ring drive gear 368 further includes an upper annular body 374 formed at the upper surface of lower annular body 370 and having the same inner diameter as lower annular body 370, but having a greater outer diameter than lower annular body 370. An annular supporting ledge 376 is formed on top of an inner annular area of upper surface of upper annular body 374 and has an inner diameter less than that of lower annular body 370 and upper annular body 374 so as to form an inner annular lip 378 which rests on the upper end of coil spring 350 and by which ring drive gear 368 is rotatably supported. A set of equiangularly arranged, axially extending, circumferentially arranged, triangular shaped teeth 380 are formed on the upper surface of upper annular body 370 and extend through annular supporting ledge 376. When ring drive gear 368 is rotated, pinion drives 326 are thereby rotated, causing cylindrical graphic gear wheel 268 to rotate in order to display a different numerical indicia 269 through large opening 262.

As shown in Figs. 31, 32 and 38, a ring plunger 336 is positioned on top of ring drive gear 368 and includes a plurality of small equiangularly spaced teeth 348 on the undersurface thereof for engagement with triangular teeth 374. However, since the outer diameter of ring plunger 336 is substantially the same as the outer diameter of annular supporting ledge 376, teeth 348 engage only with that portion of triangular teeth 374 that extends through annular supporting ledge 376. It will be appreciated that teeth 348 are much smaller in pitch than triangular teeth 374 and greatly outnumber triangular teeth 374. As will be understood from the discussion hereafter, when ring plunger 336 is moved down in the axial direction, small teeth 348 engage triangular teeth 374. This movement results in both ring plunger 336 and ring drive gear 368 moving down in the axial direction against the force of coil spring 350 until gear teeth 372 of ring drive gear 368 engage gear teeth 330 of pinion drives. At the same time, because of the triangular shape of teeth 374, this results in ring drive gear 368 being rotated by one gear tooth 348 of ring plunger 336. As a result, pinion drives 326 are thereby rotated, causing cylindrical graphic gear wheel 268 to rotate in order to display a different numerical indicia 269 through large opening 262. Ring plunger 336 also includes a plurality of recesses 346 equiangularly spaced along the outer surface thereof, with recesses 346 being open at the upper end of the outer surface, the purpose for which will become apparent from the discussion hereafter.

As shown in Figs. 31, 32 and 39-41, cover 382 is provided in covering relation to base 244, cylindrical graphic gear wheel 268, pinion drives 326, coil spring 350 and ring drive gear 368, and in partial covering relation to ring plunger 336. Cover 382 includes a continuous side wall 384 having a generally oval cross-section and which is closed by a top wall 386 having a centrally located circular opening 388. A large display window opening 385 is formed at the lower end of side wall 384 along the minor axis of the oval shape for displaying numerical indicia 269 therethrough. An annular boss 390 extends upwardly from top wall 386 in surrounding relation to opening 388. Two diametrically opposite openings 392 are formed along the longer oval axis at the upper end of side wall 384 and extending partially inward into top wall 386. When cover 382 is positioned over the aforementioned elements, the lower edge of side wall 384 sits on top closing wall 216 of bottle 212, and tabs 263 of spring fingers 259 engage the lower edges of opening 392 to retain cover 382 on bottle 212. In addition, an inwardly turned annular lip 394 is formed at the upper end of annular boss 390. A plurality of equiangularly spaced tabs 396 extend radially inwardly from the inner surface of annular lip 394. The number, shape and dimensions of tabs 396 are equal to the number, shape and dimensions of recesses 346 of ring plunger 336 for fitting therein. As a result, ring plunger 336 is limited for movement in the axial direction only and cannot rotate.

The undersurface of annular lip 394 includes a plurality of small downwardly extending triangular shaped teeth 398 which are adapted to engage with triangular shaped teeth 380 of ring drive gear 368 at a position radially outwardly of annular supporting ledge 376. With this arrangement, coil spring 350 normally biases ring drive gear 368 upwardly, and thereby, ring plunger 336 therewith, in an upwardly axial direction. At this time, gear teeth 372 of ring drive gear 368 are moved up and out of engagement with gear teeth 330 of pinion drives 326 so that cylindrical graphic gear wheel 268 is not rotated. The amount of upward travel of ring drive gear 368 is limited by triangular shaped teeth 380 engaging with triangular shaped teeth 398. Further, triangular shaped teeth 398 are out of phase with teeth 348 of ring plunger 336, whereby triangular shaped teeth 398 rotate ring drive gear 368 by a small increment. This has the effect that the rotation of ring drive gear 368 by this small increment causes triangular shaped teeth 380 thereof to force teeth 348 of ring plunger 336 out of engagement therewith. Since ring plunger 336 is only movable in the axial direction, it does not rotate, but rather, is moved axially upward therewith.

During the next actuation, when ring plunger 336 is moved down in the axial direction, small teeth 348 once again engage triangular teeth 374. This movement results in both ring plunger 336 and ring drive gear 368 moving down in the axial direction against the force of coil spring 350 until gear teeth 372 of ring drive gear 368 engage gear teeth 330 of pinion drives. At the same time, because of the triangular shape of teeth 374, this results in ring drive gear 368 being rotated by one gear tooth 348 of ring plunger 336. As a result, pinion drives 326 are thereby rotated, causing cylindrical graphic gear wheel 268 to rotate in order to display a different numerical indicia 269 through large opening 262.

As shown in Figs. 42 and 43, an actuator 352 is mounted on ring plunger 336 for biasing ring plunger 336 down against the force of coil spring 350. Actuator 352 is identical to actuator 152 of Figs. 14-16, and includes a lower thin oval shaped wall 354 that fits around the entire assembly including base 244, an upper frusto-conical nozzle wall 356 that is closed at its upper narrow diameter end by a closure wall 358 and has a very small opening 360 therein, and an annular oval shaped connecting wall 362 that connects the lower end of frusto-conical nozzle wall 356 and the upper end of lower cylindrical wall 354 and which also sits on top of ring plunger 336. A tube 364 is connected to the undersurface of closure wall 358 in surrounding relation to small opening 360 therein and extends axially down to the position of annular connecting wall 362, but is spaced therefrom. Tube 364 frictionally fits over small diameter upper pump stem 238 of pump 230 and is thereby fixed thereto. When actuator 352 is pushed down by a user, it functions to actuate pump 230 to deliver a dose in the same manner as the first embodiment described above. At the same time, it functions to push down ring plunger 336 in order to provide rotation of cylindrical graphic gear wheel 268 in the manner described above in order to display different indicia through large display window opening 385. Referring now to Figs. 44 and 45, there is shown a nasal spray pump container

410 and a dosage indicator 442 for use therewith according to a modification of the first embodiment of Figs. 1-28, in which elements corresponding to those of nasal spray pump container 10 and dosage indicator 42 of Figs. 29-43 are identified by the same reference numerals, but augmented by 400. Thus, nasal spray pump container 410 and dosage indicator 442 are the same as like elements nasal spray pump container 10 and a dosage indicator 42 of Figs. 1-28, except where indicated below. Thus, nasal spray pump container 410 and dosage indicator 442 include a base 444, cylindrical graphic gear wheel 468, display insert 478, cover 480, gears 526, plunger 536 and actuator (not shown). Specifically, as shown in Figs. 44 and 45, nasal spray pump container 410 includes a bottle 412, which is very similar to bottle 12, that is, with the same elements and arrangement of elements of a side wall 414, a top closing wall 416, a bottom closing wall 418, an opening (not shown) in top closing wall 416, an elongated hollow cylindrical neck 422, and an outwardly extending annular lip 424 at the top of elongated hollow cylindrical neck 422, a raised shoulder 426 and arcuate flanges 428. However, raised shoulder 426 has a height greater than raised annular shoulder 26 of bottle 12 and does not extend entirely around hollow cylindrical neck 422, terminating at a planar front side 427 which extends in a plane substantially tangent to hollow cylindrical neck 422, the purpose for which will become apparent hereafter. In addition, hollow cylindrical neck 422 is formed with a lower section 422a having a first diameter and an upper contiguous section 422b having a second lesser diameter, and diametrically opposite arcuate flanges 428 are provided on the outer surface of lower section 422a at the lower end thereof, spaced slightly above the upper surface of raised shoulder 426. The pump (not shown) is identical to pump 30 so that a detailed discussion thereof is not provided herein.

As shown in Fig. 44, graphic gear wheel 468 is substantially identical to graphic wheel 68" of Fig. 26, and thereby includes a spiral groove 476 therearound. In addition, however, a plurality of numerical indicia 469 are printed circumferentially along the outer surface of gear wheel 468 below spiral groove 476, starting from the number of doses initially in bottle 412, for example, 120 doses, and ending at zero. A rectangular arcuate display insert 478, preferably of a different color than graphic gear wheel 468, is similar to arcuate display insert 78" of Figs. 27 and 28. However, rather than providing a rectangular projection 79" at a front face thereof, arcuate display insert 478 includes a small rectangular opening 479 centrally thereof, at a position of about one-third the height of arcuate display insert 478, measured from the bottom edge thereof, for displaying one of the numerical indicia 469 therethrough. Small rectangular opening 479 is in alignment with display window opening 464 of base 444 for movement only in the axial direction of base 444 and which restrains arcuate display insert 478 in display window opening 464. The rear face of arcuate display insert 478 includes a plurality of circumferentially oriented projections (not shown) which are identical to projections 81" of arcuate display insert 78" and which slidably fit within spiral groove 476. Thus, as graphic gear wheel 468 is rotated, the projections ride within spiral groove 476. Because arcuate display insert 478 is restrained for movement only in the axial direction of base 444, arcuate display insert 478 moves down within display window opening 464 of base 444 when each dose is dispensed.

When the arcuate display insert 478 reaches and displays "zero" on graphic gear wheel 468 through small rectangular opening 479 thereof, the projections on arcuate display insert 478 will be unable to move further because they are at the end of the spiral groove 476. This provides a first lock out arrangement. At the same time, because raised shoulder 426 has planar front side 427, the bottom edge of arcuate display insert 478 will extend down past planar front side 427 and bottom out on the upper surface of top closing wall 416 of bottle 412. This provides a second lock out arrangement. Thus, both occurrences result in arcuate display insert 478 being locked from further movement. Because arcuate display insert 478 is connected with graphic gear wheel 468, this means that graphic gear wheel 468 is also locked from further rotation, whereby plunger 536 can no longer be depressed. This means that nasal spray pump container 410 is locked and can no longer be used.

As a further modification of the first embodiment, axially extending guide channels 114 are eliminated, and in place thereof, arcuate openings 514 are provided across substantially the entire overhanging arcuate lips 510 of cover 480. Further, racks 544 of plunger 536 are made wider than racks 144 and are provided with a cross-section of the same shape as arcuate openings 514 for sliding movement therein. Each rack 544 is provided with an elongated opening 546 therein at the upper end thereof, and a single tooth 548 is provided on one side wall of only one of the elongated openings 546. Gears 526 are rotatably positioned in respective elongated openings 546, with tooth 548 being in meshing engagement with one gear 526 for rotating the same. The non-driven one of gears 526 simply provides "balance" during the pumping stroke of nasal spray pump container 410. In all other respects, nasal spray pump container 410 is the same or substantially the same as nasal spray pump container 10, and operates in the same manner thereto. Suitable medicaments include at least one active pharmaceutical agent from the following: an anticholinergic, a corticosteroid, a decongestant, an analgesic, a non- streroidal anti-inflammatory drug, a long acting beta agonist, short acting beta agonist, a phosphodiesterase IV inhibitor and combinations of two or more thereof. Suitable medicaments may be useful for in the prevention or treatment of at least one of the following: a respiratory disease, allergies, inflammatory or obstructive airway disease. Suitable corticosteroids which may be used in the present invention include, but are not limited to, mometasone, dexamethasone, butoxicort, rofleponide, budesonide, deflazacort, ciclesonide, fluticasone, beclomethasone, loteprednol or triamcinolone and pharmaceutically acceptable salts or isomers thereof. More specifically, mometasone furoate, fluticasone furoate and fluticasone propionate may be used.

Suitable decongestants for use within the scope of the present include, without being limited to, levmetamfetamine (also known as 1-desoxyephedrine), ephedrine, ephedrine hydrochloride, ephedrine sulfate, naphazoline hydrochloride, oxymetazoline and pharmaceutically acceptable salts thereof, oxymetazoline hydrochloride, phenylephrine hydrochloride, and propylhexedrine. Suitable antihistamines include, but are not limited to, astemizole, azatadine, azelastine, acrivastine, brompheniramine, chlorpheniramine, clemastine, cyclizine, carebastine, cyproheptadine, carbinoxamine, desloratadine, doxylamine, diphenhydramine, cetirizine, dimenhydrinate, dimethindene, ebastine, epinastine, efletirizine, fexofenadine, hydroxyzine, ketotifen, loratadine, levocabastine, levocetirizine, mizolastine, mequitazine, mianserine, noberastine, meclizine, norastemizole, picumast, pyrilamine, promethazine, terfenadine, tripelennamine, temelastine, trimeprazine, triprolidine and mixtures of any two or more of the foregoing. Suitable antivirals include pleconaril.

Suitable short acting beta agonist include albuterol, terbutaline sulfate, bitolterol mesylate, levalbuterol, metaproterenol sulfate, pirbuterol acetate or a pharmaceutically acceptable salt or hydrate of any of the above, or a combination of two or more of the above.

Suitable long acting beta agonist include carmoterol, indacaterol, TA-2005, salmeterol, formoterol, or a pharmaceutically acceptable salt or hydrate of any of the above, or a combination of two or more of the above.

Suitable phosphodiesterase IV inhibitors include cilomilast, roflumilast, tetomilast, l-[[5-(l(S)-aminoethyl)-2-[8-methoxy-2-(trifluoromethyl)-5-quinolinyl]-4- oxazolyl]carbonyl]-4(R)-[(cyclopropylcarbonyl)amino]-L-proline, ethyl ester or a pharmaceutically acceptable salt or hydrate of any of the above, or a combination of two or more of the above.

Having described various embodiments of the invention with reference to the accompanying drawings, it will be appreciated that the present invention is not limited to those precise embodiments and that various changes and modifications can be effected therein by one of ordinary skill in the art without departing from the scope or spirit of the invention as defined by the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A dosage counter for a spray pump container of the type including a container with a neck for holding a liquid therein and a pump extending through the neck for delivering doses of the liquid from the container, the dosage counter comprising: a base mounted on the container around the neck thereof, the base including a display window; a graphic wheel rotatably mounted around the neck and within the base, the graphic wheel having at least one indicator thereon to be displayed through the display window for indicating an amount of doses remaining in the container after delivery of each dose from the container; an actuator connected with the pump and movable in an axial direction of the container for controlling the pump to deliver a dose of the liquid during each axial movement thereof in a direction toward the container, the actuator including a delivery nozzle at a free end thereof for delivering a spray dose of the liquid; and a mechanism connected between the actuator and the graphic wheel for causing rotation of the graphic wheel by an incremental distance in response to each axial movement of the actuator in a direction toward the container, such that the at least one indicator displays an amount of doses remaining in the container through the display window.

2. A dosage counter according to claim 1, wherein the graphic wheel includes a plurality of gear teeth arranged circumferentially therearound, and the mechanism includes at least one drive gear, each drive gear having a plurality of gear teeth adapted to be in meshing engagement with the gear teeth of the graphic wheel.

3. A dosage counter according to claim 2, wherein the plurality of gear teeth of the graphic wheel are arranged circumferentially on an upper edge thereof, and each drive gear includes an axis which is orthogonal to the axial direction of the container.

4. A dosage counter according to claim 3, wherein the mechanism further includes at least one rack movable by said actuator in the axial direction of the container, at least one said rack including a tooth for engagement with the gear teeth of a respective said drive gear for rotating the respective drive gear around said orthogonal axis, which in turn, causes rotation of the graphic wheel.

5. A dosage counter according to claim 4, wherein said base supports each said drive gear for rotation around said orthogonal axis, and said base includes at least one guide channel for slidably guiding said at least one rack for movement in said axial direction.

6. A dosage counter according to claim 4, wherein the at least one drive gear includes two said drive gears and the mechanism includes a plunger movable by said actuator in the axial direction of the container, the plunger including two racks and each said rack including one said tooth for engagement with the gear teeth of a respective said drive gear for rotating the respective drive gear around said orthogonal axis.

7. A dosage counter according to claim 6, further comprising a spring for normally biasing said plunger and said actuator in an axial direction away from said container such that said gear teeth of said drive gears are moved out ot engagement with the gear teeth of the graphic wheel.

8. A dosage counter according to claim 2, wherein the plurality of gear teeth of the graphic wheel are arranged circumferentially at a lower end thereof, and each drive gear includes an axis which is parallel to the axial direction of the container.

9. A dosage counter according to claim 8, wherein each drive gear includes a lower pinion mounted at a lower end of a shaft which is rotatable in the axial direction of the container.

10. A dosage counter according to claim 9, wherein an upper pinion is formed at an upper end of each said shaft, and said mechanism further includes a ring drive gear rotatably mounted on the pump and having gear teeth for meshing with gear teeth of at least one said upper pinion.

11. A dosage counter according to claim 10, wherein the mechanism includes an arrangement for converting axial movement of the actuator to rotational movement of the ring drive gear.

12. A dosage counter according to claim 11, wherein the arrangement includes: a plurality of ramped gear teeth on an upper surface of said ring drive gear; and a ring plunger positioned above said ring drive gear for movement only along the axial direction of the container, the ring plunger having a lower surface with small gear teeth thereon for engagement with the ramped gear teeth, such that each engagement of the small gear teeth with the ramped gear teeth results in rotation of the ring drive gear.

13. A dosage counter according to claim 12, further comprising: a spring for normally biasing said ring drive gear, said ring plunger and said actuator in an axial direction away from said container such that said gear teeth of said ring drive gear are moved out of engagement with the gear teeth of the at least one said upper pinion; and a cover for covering said base, said graphic wheel, said actuator and said mechanism on the container, said base including an upper portion with downwardly extending gear teeth for engaging the ramped gear teeth upon movement of said ring drive gear by said spring away from said container and out of engagement with the gear teeth of the at least one upper pinion such that said downwardly extending gear teeth rotate said ring drive gear by an increment to reset the ring drive gear for engagement with the gear teeth of the ring plunger during the next actuation of the actuator.

14. A dosage counter according to claim 1, wherein the at least one indicator of the graphic wheel includes a strip on an outer surface of the graphic wheel that reduces in height circumferentially around the graphic wheel.

15. A dosage counter according to claim 1, wherein the at least one indicator of the graphic wheel includes a spiral line on an outer surface of the graphic wheel that moves down circumferentially around the graphic wheel.

16. A dosage counter according to claim 1, wherein: the graphic wheel includes a spiral groove therearound, the at least one indicator includes an insert slidably mounted in said spiral groove, and the base includes an arrangement for restraining rotational movement of the insert while permitting axial movement of the insert, such that the insert moves in the axial direction of the container as the graphic wheel is rotated.

17. A dosage counter according to claim 1, wherein the at least one indicator includes numerical indicia on an outer surface of the graphic wheel, corresponding to the number of doses remaining in the container.

18. A dosage counter according to claim 1 , wherein: the graphic wheel includes a spiral groove therearound and numerical indicia on an outer surface of the graphic wheel, corresponding to the number of doses remaining in the container; the at least one indicator includes an insert slidably mounted in said spiral groove, the insert including an opening therein for displaying one of the numerical indicia therethrough in dependence on the rotational position of the graphic wheel; and the base includes an arrangement for restraining rotational movement of the insert while permitting axial movement of the insert, such that the insert moves in the axial direction of the container as the graphic wheel is rotated.

19. A dosage counter according to claim 1 , further comprising at least one lock out mechanism that prevents actuation of the pump when the at least one indicator indicates a predetermined amount.

20. A dosage counter according to claim 19, wherein the at least one lock out mechanism is triggered when the graphic device indicates that no doses are remaining.

21. A drug product comprising: at least one medicament in a solution or suspension located in a container; wherein the container comprises a dosage counter comprising at least one indicator for indicating an amount of doses of medicament and the container further comprises at least one lock-out mechanism to prevent the medicament from being dispensed from the container when the counter indicates a pre-determined amount of doses.

22. The product of claim 21 , wherein the product is a nasal spray.

23. The product of claim 21, wherein said at least one counter comprises at least one display window; at least one graphic wheel, the at least one graphic wheel having the at least one indicator thereon to be displayed through at least one display window for indicating an amount of doses.

24. The product of claim 21, wherein the container comprises a pump for delivering doses of the medicament from the container and the dosage counter comprising: at least one graphic device having at least one indicator thereon to be displayed through the at least one display area; an actuator connected with the pump and movable for controlling the pump to deliver a dose of the liquid during each movement thereof, the actuator including a delivery nozzle for delivering a spray dose of the liquid; and a mechanism connected between the actuator and the at least one graphic device for causing movement of the at least one graphic device by an incremental distance in response to each movement of the actuator, such that the at least one indicator is visible through the at least one display area.

25. A product useful to minimize or prevent the use or administration of subpotent doses of a medicament contained in a nasal spray container comprising a dosage counter and at least one locking mechanism that prevents the nasal spray from actuating when the dosage counter indicates a pre-determined amount.

26. The product of claim 25, wherein the product is a nasal spray container that is free of propellants.

27. The product of claim 25 wherein the pre-determined amount is an amount greater than the start of when subpotent doses of a medicament might be released from the nasal spray.

28. The product of claim 25, wherein the counter indicates a number of doses used or left in the container.

29. The product of claim 25, wherein the counter comprises at least one display window; at least one graphic wheel, the at least one graphic wheel having at least one indicator thereon to be displayed through at least one display window for indicating an amount of doses.

30. The product of claim 25, wherein the container comprises a pump for delivering doses of the medicament from the container and the dosage counter comprising: at least one graphic device having at least one indicator thereon to be displayed through the at least one display area; an actuator connected with the pump and movable for controlling the pump to deliver a dose of the liquid during each movement thereof, the actuator including a delivery nozzle for delivering a spray dose of the liquid; and a mechanism connected between the actuator and the at one least graphic device for causing movement of the at least one graphic device by an incremental distance in response to each movement of the actuator, such that the at least one indicator is visible through the at least one display area.

31. A container comprising a liquid therein and a pump for delivering doses of the liquid from the container and a dosage counter, said dosage counter comprising: at least one graphic device having at least one indicator thereon to be displayed through the at least one display area; an actuator connected with the pump and movable for controlling the pump to deliver a dose of the liquid during each movement thereof, the actuator including a delivery nozzle for delivering a spray dose of the liquid; and a mechanism connected between the actuator and the at least one graphic device for causing movement of the at least one graphic device by an incremental distance in response to each movement of the actuator, such that the at least one indicator is visible through the at least one display area.

32. The container of claim 31, further comprising at least one lock out mechanism that prevents actuation of the pump when the graphic device indicates a predetermined amount.

33. The container of claim 32, wherein the at least one lock out mechanism is triggered when the graphic device indicates that no doses remain.

34. The container of claim 32, wherein the container consists of two lock out mechanisms.

35. The container of claim 32, wherein the at least one lock out mechanism stops the at least one graphic device from moving which prevents the pump from being depressed which prevents the nasal spray from being used.

36. A dosage counter for a spray pump container, the container comprising a neck for holding a liquid therein and a pump extending through the neck for delivering doses of the liquid from the container, the dosage counter comprising: a base mounted on the container around the neck thereof, the base including at least one display area; at least one graphic wheel rotatably mounted around the neck and within the base, the at least one graphic wheel having at least one indicator thereon to be displayed through the at least one display area for indicating an amount of doses; an actuator connected with the pump, the actuator including a delivery nozzle for delivering a dose of the liquid; and a mechanism connected between the actuator and the graphic wheel for causing rotation of the graphic wheel by an incremental distance in response to each movement of the actuator, such that the at least one indicator displays an amount of doses in the display area.

37. The counter of claim 36, further comprising at least one lock out mechanism that prevents actuation of the pump when the graphic device indicates a predetermined amount.

38. The counter of claim 37, wherein the at least one lock out mechanism is triggered when the graphic device indicates that no doses of the liquid remain.

39. The counter of claim 37, wherein the container consists of two lock out mechanisms.

40. The counter of claim 37, wherein the at least one lock out mechanism stops the graphic at least one wheel from moving which prevents the spray pump from being depressed which prevents the nasal spray from being used.