Abstract:
To overcome shortcomings of the prior art, the subject invention is provided which includes various dropper bottle designs and dropper bottle assemblies including accessories for dropper bottles. With certain aspects of the subject invention, improvements in the administration of eye drops is provided by adding accessories or modifications to conventional dropper bottles, so that doses and/or single drops may be administered in a repeatable and reliable manner. More specifically, certain embodiments use devices ( 10, 300 ) to restrict the amount the dropper bottle ( 12 ) is deformed in administering a dose; other embodiments rely on mechanical reduction of interior volume (without deformation of the dropper bottle ( 12 )) to administer a dose, such as with a displaceable piston ( 500, 602 ); and, yet, a further embodiment provides a valving arrangement ( 402, 404 ) to limit a dose. Features ( 200 ) are also included which aid in the alignment of the dropper bottle&#39;s nozzle to the eye, and a feature ( 102 ) is provided for protecting the user&#39;s eye from potential damage which can occur if a pointed nozzle ( 104 ) is brought into contact with the eye during alignment. As will be appreciated by those skilled in the art, the various aspects and embodiments disclosed herein may be used singularly or in various combinations.

Description:
[0001]     This application claims priority to U.S. Provisional Patent Application No. 60/401,397, filed Aug. 6, 2002. 
     
    
       [0002]     Conventional dropper bottles for administering ophthalmic fluid are well known in the prior art. The basic commercial design of such dropper bottles has remained fairly unchanged over the last several decades: a squeezable container is provided with a tapered dispenser that terminates in a discharge aperture. To administer ophthalmic fluid, the discharge aperture is aligned above a target eye and the bottle is squeezed to urge out a drop or dose of the fluid.  
         [0003]     Although the conventional design is widely used, it suffers from several drawbacks. Primarily, dose volume is difficult to repeatedly control, in part, because a proper amount of squeeze force is difficult to repeatedly apply to the dropper bottle. Also, accurate control over and targeting of dose placement are difficult to obtain.  
       SUMMARY OF THE INVENTION  
       [0004]     To overcome shortcomings of the prior art, the subject invention is provided which includes various dropper bottle designs and dropper bottle assemblies including accessories for dropper bottles. With certain aspects of the subject invention, improvements in the administration of eye drops is provided by adding accessories or modifications to conventional dropper bottles, so that doses and/or single drops may be administered in a repeatable and reliable manner. More specifically, certain embodiments restrict the amount the dropper bottle is deformed in administering a dose; other embodiments rely on mechanical reduction of interior volume (without deformation of the dropper bottle) to administer a dose, such as with a displaceable piston; and, yet, a further embodiment provides a valving arrangement to limit a dose. Further features are included which aid in the alignment of the dropper bottle&#39;s nozzle to the eye, and also protect the user&#39;s eye from potential damage which can occur if a pointed nozzle is brought into contact with the eye during alignment. As will be appreciated by those skilled in the art, the various aspects and embodiments disclosed herein may be used singularly or in various combinations.  
         [0005]     Unless indicated otherwise, any conventional dropper bottle design and component may be utilized with the subject invention. It should also be understood that reference to a “nozzle” does not require that a converging discharge passage be provided. Any shaped discharge passage can be utilized with the subject invention consistent with the following description. The subject invention is particularly well-suited for ophthalmic applications (i.e., dispensing of eye-related fluids).  
         [0006]     These and other features of the subject invention will be better understood through a study of the following detailed description and accompanying drawings. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0007]      FIGS. 1-3  show a dropper bottle assembly including a cradle for controllably deforming the dropper bottle in causing dose administration therefrom;  
         [0008]      FIG. 4  is a dropper bottle similar to that of  FIGS. 1-3  but with a collar disposed about its nozzle;  
         [0009]      FIG. 5  is a dropper bottle similar to that of  FIGS. 1-3  but with an angled nozzle;  
         [0010]      FIGS. 6-8  show the assembly and operation of a webbed structure in a dropper bottle for limiting deformation of the dropper bottle;  
         [0011]      FIGS. 9-11  show a dropper bottle having a tube therein with a check valve ball; and,  
         [0012]      FIGS. 12-16  show different piston configurations for reducing the interior volume of a dropper bottle in causing dose administration therefrom. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0013]     Several embodiments of the subject invention are directed to the problem that most current dropper bottles require the bottle to be deformed, e.g. squeezed, in order to generate pressure inside the bottle and, thereby, expel a dose or drop. This practice is problematic because the user is often unable to determine how hard to press the bottle, and for how long a period of time, so that a single drop is expelled. Usually, more than one drop is expelled, which may be wasteful and messy.  
         [0014]     With reference to  FIGS. 1-3 , and in a first aspect of the subject invention, a cradle  10  is depicted which is formed to mount onto a dropper bottle  12  preferably by resiliently snapping onto the bottle  12  at the neck  14  and base  16 . Preferably, the cradle  10  is formed of a resilient material, more preferably, a resilient thermoplastic. Mounting of the cradle  10  onto the neck  14  is facilitated by the provision of a hole  18  formed large enough to allow the bottle  12  to partially pass therethrough. In particular, the neck  14  of the bottle  12  may pass through the hole  18 ; preferably, however, the hole  18  is sized to not allow the passage therethrough of the reservoir  20  of the bottle  12 . Once the cradle  10  is mounted, the bottle neck  14  is preferably pushed off-center from the hole  18  ( FIG. 3 ) due to pressure exerted transversely by a portion  22  of cradle lever  24  against an outer wall  23  that defines the reservoir  20 . The bottle  12  is further confined by side plate  11  of the cradle  10 . The portion  22  presses the bottle  12  against inner surface  13  of the side plate  11 . Preferably, the portion  22  is bent. In addition, the lower end  26  of the cradle  10  may seat in an indentation  28  in the base  16  of the bottle  12  and resiliently press thereagainst. As such, the cradle  10  preferably traps the bottle  12  at multiple points: at the hole  18 ; at the portion  22 ; at the inner surface  13 ; and at the lower end  26  of the cradle  10 . As will be appreciated by those skilled in the art, the cradle  10  may be configured otherwise to mount onto the dropper bottle  12 . The cradle  10  may be formed to be removable so as to be re-used with other dropper bottles or formed to be non-removably mounted to the dropper bottle, thus requiring to be discarded with a spent dropper bottle.  
         [0015]     In use, free end  30  of the cradle lever  24  is pressed towards the bottle  12  as the bottle  12  is inverted to deliver one or more drops. As the free end  30  is pressed inwardly, and as shown in  FIG. 2 , the portion  22  indents a side of the reservoir  20  adjacent to the neck  14 , thus deforming the outer wall  23  and reducing the volume of the reservoir  20 . As a result, one or more drops may be controllably expelled. The dosage amount may be fixed to a predetermined extent of movement of the cradle lever  24 , such as by example, restricting movement of the cradle lever  24  with a stop member. Optionally, at the point where the predetermined drop(s) are expelled (i.e., at a predetermined extent of movement of the cradle lever  24 ), the user may be alerted to a complete dosing wherein a toe  32  of the cradle lever  24  may nest into a recess  34  defined in the lower end  26 , with an audible and/or tactile ‘click’ indicating that the desired drop(s) have been released from the bottle  12 . Upon detecting this ‘click’, the user may release the free end  30  of the lever  24 , which returns back to its fully open rest position (shown in  FIG. 1 ). Preferably, hinge  25  provides a biasing force to urge the lever  24  to the rest position as shown in  FIG. 1 , where the dropper bottle  12  is undeformed or substantially undeformed. Further drops may then be released. Preferably, the hinge  25  also exerts a biasing force to press the portion  22  against the outer wall  23  without causing deformation or substantial deformation of the reservoir  20  so that unwanted dosing is avoided. To achieve this structure, the cradle  10  can be formed with the portion  22  in its natural state so as to overlap the reservoir  20 . Likewise, the lower end  26  of the cradle  10  may be formed to overlap the reservoir  20 .  
         [0016]     As shown in  FIG. 4 , and in a second aspect of the subject invention, a nozzle  100  may be provided on the dropper bottle  12  which is at least partially surrounded by a protruding outer collar  102 . Preferably, the collar  102  terminates in a generally flat free end  106 , and, more preferably, the free end  106  is disposed generally normally to central axis CA of the nozzle  100 . Also, the collar  102  is preferably annular. The collar  102  encompasses a volume in which tip  104  of the nozzle is located. As a result, the collar  102  projects beyond the tip  104  of the nozzle  100  such that, if contact is made with an eye during use, the outer collar  102  will contact the eye and not the nozzle tip  104 . The free end  106  at the front of the collar  102  will be less likely to cause the user any eye damage than the sharper nozzle tip  104 . The nozzle  100  may be constructed from plastics such as polyethylene or polypropylene, or softer elastomers may be used as a further safety measure.  
         [0017]     In a third aspect of the subject invention, a nozzle of a dropper bottle (e.g. nozzle  100 ) may be colored to further aid in the alignment process. As such, the nozzle  100  is non-transparent and non-translucent and provided with a non-white color. Colors are more easily visible to the eye than the colorless plastics used in conventional dropper bottle nozzles and a colored nozzle will be easier to visually align. The nozzle  100  may also be of a different color from its associated reservoir to provide additional contrast and improved visibility of the nozzle  100 . Further, colors may be used for the nozzle  100  or around the nozzle  100  to denote the contents of the dropper bottle.  
         [0018]     As a further aid to alignment, as shown in  FIG. 5 , nozzle  200  may be directed at an angle to aid the placement of drops into the eye. Here, discharge aperture  202  is spaced from a central axis CB of reservoir  20 . Preferably, the nozzle  200  is formed symmetrically along at least a portion of a central axis CD which is angularly disposed to the central axis CB. Angle α is defined between the central axes CD and CB and may be in the range of greater than 0° to approximately 135°.  
         [0019]     In a fourth aspect of the subject invention, and with reference to  FIGS. 6-8 , a device  300  is provided which limits the degree of deformation of the dropper bottle  12  to such an amount necessary to expel one dose or drop. The device  300  includes at least one, preferably a series of, outwardly-extending webs  302 , like tree branches, which project from a central column  304  that is in communication with nozzle  306  and the reservoir  20 . Preferably, the central column  304  is fixed to the nozzle  306 , such as by being formed integrally therewith, in forming the device  300 . Any method may be used to fix the device  300  to the bottle  12  including an interference fit in the neck  14  of the bottle  12 . A locking detent  308  may also be provided to enhance the fixation of the device  300  to the bottle  12 .  
         [0020]     The column  304  may optionally be formed with one or more apertures  310 , as shown in  FIG. 8 , to communicate the interior of the column  304  with the reservoir  20 .  
         [0021]     By way of non-limiting example, for installation, the device  300  may be inserted through the neck  14  with the webs  302  bending backwards through the neck  14  ( FIG. 6 ) and returning to their original shape ( FIG. 7 ) whilst in the reservoir  20  after installation. As shown in  FIG. 8 , once installed, the webs  302  are shaped and configured to limit the amount of deformation of the outer wall  23  to a predetermined amount in limiting the amount to be dosed ( FIG. 8 ).  
         [0022]     Although the webs  302  may be formed sufficiently resilient to pass through the neck  14 , the webs  302  need sufficient strength in compression to resist buckling and excessive deformation of the outer wall  23 . It is preferred that the webs  302  be disposed generally normally to the generally cylindrical portion of the outer wall  23 . Also, as will be appreciated by those skilled in the art, the webs  302  can be formed as annular discs as shown in the Figures or in other various configurations and supported in any manner.  
         [0023]     In a fifth aspect of the subject invention, and as shown in  FIGS. 9-11 , a device  400  is provided which limits the amount of liquid dispensed by a dropper bottle  12  to one drop or dose. The device  400  generally includes a check valve ball  402  which is free to run within a tube  404 . The tube  404  extends from nozzle  406  and has a number of slots or openings  408  formed therethrough which allow fluid communication between inside  409  of the tube  406  and the reservoir  20 . Also, the end of the tube  406  may be spaced from the outer wall  23 , such as at the base  16 , with the tube  404  communicating with the reservoir  20  via spacing  401 . Preferably, the tube  404  is formed to continuously maintain the ball  402  therewithin. As such, the openings  408  and the spacing  401  may be sized to not permit passage therethrough of the ball  402 . The end of the tube  404  adjacent to the nozzle  406  has a first section  410  sized to receive the ball  402  therewithin so as to form a fluid seal therewith. Portions of the tube  404  adjacent the first section  410  are generally larger than the first section  410 . The first section  410  communicates with discharge passage  412  of the nozzle  406  and preferably encompasses a volume at least equal to a single dose to be administered by the dropper bottle  12 .  
         [0024]     In use, the ball  402  drops to the bottom of the bottle  12  when the bottle is upright and rested on its base  16  ( FIG. 9 ). As the bottle  12  is inverted for use (with the nozzle  406  being directed downwards) ( FIGS. 10-11 ), liquid in the reservoir  20  enters the openings  408  to flood the inside of the tube  404 , and the ball  402  drops down through the tube  404  towards the nozzle  406 . As the ball  402  reaches the first section  410 , the first section  410  is already flooded and fully charged with liquid ( FIG. 10 ). The ball  402  generally seals the first section  410  from remaining portions of the tube  404 . By applying pressure to the wall of the reservoir  20  (such as with normal drop administration), fluid within the reservoir  20  is pressurized which forces the ball  402  through a defined stroke of the first section  410 . In turn, the ball  402  displaces fluid along its path through the first section  410  resulting in an expelled drop of equal volume to the swept volume of the ball  402  (swept volume being the displaced volume during travel of the ball  402 ). In other words, the ball  402  generally displaces the full volume of the first section  410 . As the ball  402  reaches the end of travel it will shut-off against a seat  414  and no more liquid can be expelled ( FIG. 11 ). Thereafter, the dropper bottle  12  can be righted and the process repeated.  
         [0025]     In a sixth aspect of the subject invention, an alternative to the above means of expelling a drop by deformation of a dropper bottle is provided by a piston  500  as shown in  FIGS. 12-13 . In this configuration, the piston  500  is displaceable from an initial position as shown in  FIG. 12 , and towards, possibly into, the reservoir  20  to an actuated position as shown in  FIG. 13 , so as to reduce the interior volume of the dropper bottle  12 . Accordingly, a pressure rise is created in the bottle  12 , and this rise in pressure causes a drop or dose to be expelled from the bottle  12  when the bottle  12  is inverted for use. As will be appreciated by those skilled in the art, the bottle  12  need not be deformable, since deformation is not required for dose administration.  
         [0026]     The piston  500  extends through piston bore  502  which may be formed through plug  506  or the outer wall  23 . To facilitate assembly, it is preferred that nozzle  508  be unitarily formed with the plug  506 . The plug  506  may be fixed to the bottle  12  using any known method including an interference fit in the neck  14  of the bottle  12 . A locking detent  510  may also be provided to enhance the fixation of the plug  506  to the bottle  12 . Any known technique may be used to seal the piston bore  502  from leaking with the piston  500  being slidably disposed therein. For example, piston seal  517  may be provided as is known in the art to seal against the wall of the piston bore  502 .  
         [0027]     It is preferred that a spring  512  be provided to urge the piston  500  to an initial position, as shown in  FIG. 12 . As such, after use and release of the piston  500 , the piston  500  may return to its initial position and be ready for subsequent dosing. Also, a shoulder  514  may be formed at the end of the piston bore  502  to coact with stop member  516  on the piston  500  to prevent excessive rearward movement of the piston  500  under force of the spring  512 . A button  518  may further be provided on the piston  500  to provide a good surface against which a user may apply pressure in displacing the piston  500 .  
         [0028]     With reference to  FIGS. 14-16 , and as a variation of the sixth aspect of the subject invention, a device  600  is provided which includes a nozzle  602  that acts as a piston. More specifically, the nozzle  602  is displaceable within the bottle  12  to reduce the interior volume thereof. The nozzle  602  is disposed to translate within the neck  14 . The nozzle  602  is formed with a discharge aperture  605  at one end in communication with an inlet opening  607  at the other end. Upon displacing the nozzle  602  downwardly to an actuated position as shown in  FIG. 15 , pressure within the interior volume of the dropper bottle  12  is increased resulting in fluid being displaced from the interior of the dropper bottle  12  through the nozzle  602  via the inlet opening  607  and out the discharge aperture  605 . Piston seal  614  may be provided to cooperate with the neck  14  in defining a seal therewith. As with the previous design, the dropper bottle  12  need not be deformable.  
         [0029]     The nozzle  602  is preferably biased by a spring  612  to an initial state as shown in  FIG. 14 . Shoulder  616  and stop member  618  can be provided to coact and prevent excessive rearward movement of the nozzle  602  under force of the spring  612 .  
         [0030]     Optionally, cradle  604  may be provided to facilitate actuation of the nozzle  602 . The cradle  604  is preferably formed to resiliently snap about the dropper bottle  12  at the nozzle  602  and the bottle base  16 , and is used to impart inward motion to the nozzle  602  (downward motion towards the base  16 ). To this end, a free end  606  of the cradle  604  is pressed transversely towards the bottle  12 . As a result, a forked end  608  of the free end  606  translates across at least one rounded face  610  of the nozzle  602 . As best shown in  FIG. 16 , the forked end  608  may straddle tip  609  of the nozzle  602  and provide stability of the cradle  604  relative to the dropper bottle  12 . As the forked end  608  translates, the forked end  606  drives the nozzle  602  against the spring  612  (in the direction of the base  16 ) so that the nozzle  602  moves downwardly. This downward translation is achieved by the rotation of the forked end  608  about pivot  611 . The rotation in effect shortens the radius of the forked end  608  in relation to the pivot  611 , thus causing increased force to be applied against the rounded face  610 . The interface of rounded surfaces between the forked end  608  and the rounded face  610  is desired to limit resistant frictional forces being defined therebetween. Upon release, the spring  612  urges the nozzle  602  upwardly. The memory of pivot  611  may also urge the cradle  604  to its initial state as shown in  FIG. 14 . It is preferred that the cradle  604  be formed of a resilient material, such as a resilient thermoplastic. To achieve a resilient holding force, the cradle  604  may be formed to overlap portions of the dropper bottle  12 .  
         [0031]     As is readily apparent, numerous modifications and changes may readily occur to those skilled in the art, and hence it is not desired to limit the invention to the exact construction operation as shown and described, and accordingly, all suitable modification equivalents may be resorted to falling within the scope of the invention as claimed.