Abstract:
A nasal spray apparatus for simultaneously administrating metered amounts of multiple medicaments includes chambers for separately storing incompatible medicaments, such as an antihistamine and a steroid. Reciprocal piston pumps allow the medications to be sprayed into the user&#39;s nasal cavity. Two pumps can be used to separately transfer the medicaments to a receptacle where they can be initially mixed just prior to administration. A small volume receptacle is used to reduce the amount of mixture remaining after each stroke of the nasal spray apparatus. A check valve can be associated with each pump to further reduce medicament mixtures from cross contamination within storage chamber preparations. Collapsible components, including collapsible storage chambers or balloon capacitors can be employed to compensate for vacuums and back pressures as the medicaments are pumped to a spray nozzle.

Description:
FIELD OF THE INVENTION 
     The present invention relates to dispensing devices and methods for administering medicaments. More particularly, the present invention relates to devices and methods which are well suited for use as nasal spray devices and methods for separately preserving and simultaneously delivering two or more medicaments for treating illnesses or conditions through the nasopharyngeal region. 
     BACKGROUND OF THE INVENTION 
     For many years physicians have treated allergies and other medical conditions by employing the use of nasal sprays. As pharmaceutical allergy care has advanced over the years, so has the delivery system of these pharmaceutical agents. Efforts have been directed at targeting sites topically which have lead to improvements in therapeutic efficacy and reduced systemic side effects. There has been research and development relating to the use of combinations of active ingredients as well. Of course, in some cases it may be desired to administer a drug in combination with another drug to take advantage of a synergistic effect between the two drugs. However, this approach can be problematic if the two drugs cannot be stored together because of an incompatibility problem. 
     For example, aqueous preparations of nasal steroids and antihistamines have been utilized in modern allergy care with great success. Recent investigations and observations from clinicians have noted a synergistic effect demonstrating improved outcomes when using both product classes consecutively. However, attempts to combine the two as a single modality of care has been futile due to problems with drug solubility and compatibility between the drug classes. 
     Thus it would be desirable to have a nasal spray system allowing for two or more drugs to be stored separately and dispensed simultaneously through a single nasal dispensing device. The system of this invention is designed to overcome problems with potential drug interactions, solubility or incompatibilities while allowing for predetermined amounts of medications to be delivered at the desired target site. This invention overcomes these obstacles by creating an alternative delivery system. 
     These and other advantages of the present invention will be apparent from the following disclosure and claims taken in conjunction with the accompanying drawings. 
     SUMMARY OF THE INVENTION 
     The invention relates to a metered nasal spray dispensing device that allows for two aqueous preparations to be stored separately and be dispensed simultaneously as a single spray or mist at the desired target within the nasal airway. The medicaments are mixed instantaneously at the time of an actuation of the spray device as it leaves the spray nozzle. This allows for the simultaneous use of both medicaments without the pitfalls of potential interactions or incompatibilities between the two. 
     The preferred embodiment of the device consists of two separate storage chambers with each chamber having a conduit of continuity to a metered pump. Each pump is associated with a one way check valve to prevent reflux contamination from the medicine in the contra lateral chamber. A receptacle containing a conduit for each medicine permits the mixing of the two prior to leaving the spray nozzle. Thus, with each actuation of the spray each pump moves each medicament from its chamber through a micro check valve then into a receptacle and out a spray nozzle as part of a mixture of both medicaments in the form of a mist. The spray leaving the nozzle containing both medicaments is then deposited in the nasal airway at the desired target. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a more complete understanding of this invention reference can be made to the embodiment illustrated with the following text and drawings. 
         FIG. 1  is a side elevational view of a preferred embodiment of a nasal spray device of the present invention. 
         FIG. 2  is an exploded view showing details of the pump, receptacle and nozzle components. 
         FIG. 3  is a side view of an alternate embodiment employing a bifurcated rigid container or bottle. 
         FIGS. 4A-4D  are views of a third version employing syringe chambers.  FIG. 4A  is a front elevational view of the syringe version of this invention.  FIG. 4B  is a side elevational view of the syringe version.  FIG. 4C  is a cross section along section lines  4 C- 4 C of  FIG. 4A  showing the top of the syringe version.  FIG. 4D  is a cross section along section lines  4 D- 4 D in  FIG. 4A  showing the intake at the bottom of the piston pumps. 
         FIG. 5  is a side view illustrating an alternative preferred embodiment; whereas, the nasal spray device of the present invention employs a single pump system with dual chambers. 
         FIG. 6  is a side view illustrating another alternate embodiment of the present invention using a multi fenestrated nozzle tip. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     As used herein, the following terms can be understood as follows: 
     Chamber refers to a closed compartment either collapsible (balloon, bag or syringe like) or rigid containing a liquid state of the medicament. 
     Pump refers to a mechanical device used to move the medication from the chamber. 
     Receptacle refers to a device that allows for a conduit of communication where medications meet prior to or during a spray actuation. 
     Capacitor refers to an expandable device used to compensate for back pressure in the system during pump use. 
     Check Valve refers to a mechanical device that facilitates unidirectional fluid flow. 
     Stylet refers to a rigid solid cylindrical shaped device that occupies dead space and provides support in a hollow elongated structure. 
     Now referring  FIG. 1 , the preferred embodiment of a nasal spray apparatus  2  of the present invention is illustrated. In this embodiment there are two collapsible chambers  30 ,  32  in a surrounding rigid vented, but not necessarily air tight, housing or bottle  10 . The venting of the housing or bottle  10  prevents a vacuum from developing in the housing  10 . Each chamber  30 ,  32  is drained by a metered pump  50 ,  52  and has a sack, bag or bladder-like form that collapses as the liquid medicament is consumed or transported. The bottle or housing  10  may include an internal wall separating the two chambers. The chambers  30 ,  32  are preferentially vertically oriented. As seen in  FIG. 1 , each pump  50 ,  52  is connected to a single shared receptacle  40  formed in a spray nozzle  20 . The receptacle  40  houses a check valve  60  for each pump  50 ,  52  and provides a conduit where two medicaments are initially mixed as the medicaments enter the spray nozzle  20 . As seen in  FIGS. 1 and 4 , the receptacle  40  provides spaces  42 ,  44  for clearance for the check valves  60  to move from the closed position shown in  FIG. 1  to an open position. Receptacle  40  also includes an internal passage  46  connecting spaces  42 ,  44  and a passage  48  leading to the spray tip  22  of spray nozzle  20 . The nasal spray apparatus  2  can be activated by the user in the same what that a user would actuate a conventional nasal spray devices. The spray nozzle  20  is merely depressed relative to the bottle  10  to dispense the contents into the nasal passages of the user. 
       FIG. 2  shows details of components for pumps  50 ,  52 , receptacle  40  and spray nozzle tip  22  that can be employed with the embodiment of  FIG. 1  as well as with other embodiments to be subsequently discussed in more detail. Each pump  50 ,  52  includes a pump housing  70 , a vented plunger  74  with a plunger neck  54 , stoppers  80  or  82  and two springs  76 ,  78 . It should be understood that the drawings and embodiments are not necessarily to scale and serve as illustrative representations only. Indeed certain dimensional relationships are not to scale in order to illustrate important aspects of the invention, which would not be visible if the drawings were entirely to scale. While the complete embodiment of this invention is unique, a rather conventional pump including features of most metered spray pumps can be employed. The housing  70  contains a fixed predetermined volume to allow for a predetermined amount of medicament to be dispensed with each pump stroke. The top of each pump consists of the plunger  74  that is fenestrated. The fenestration allows for the passage of medicaments to leave the pumps  50 , 52  and pass through the check valves  60 . Each check valve  60  comprises a check valve needle  66  and a check valve seat  62 . The apex of the plunger is covered with a check valve needle  64  that slides in and out of the fenestration of the plunger  74  and into the receptacle  40  with pump action. This makes up a micro check valve configuration. The pin  64  has a smaller diameter than the opening or fenestration in the top of the plunger  74 . Each check valve  60  includes a head  66  from which the pin  64  extends. When the check valve  60  moves to the open position shown in  FIG. 2 , the valve pin head  66  is spaced from a valve seat  62  on the top of the plunger  74  so that liquid medicament can flow through the opening between the check valves  60  and their respective seats  62 . This particular feature of the pump design is unique. When depressing the pumps  50 ,  52 , the check valve needle  64  rises and opens the check valve  60  to allow for medicament to pass from the pumps  50 ,  52  into the receptacle  40 . The medicaments from each chamber  30 ,  32  are forced through the respective pumps and into the receptacle  40  during the down stroke of the pump plunger  74 . First spring  76  forces the stopper  80 , or  82  down to close off the respective intake hose  84  or  86 , leading to chambers  30 ,  32 , during the down stroke, so that only direction in which the liquid medicament previously stored in the pump housing  70  can flow is out the top of the respective piston pumps  50 ,  52 . After multiple medicaments are mixed in the receptacle  40 , the medicaments are forced through the spray nozzle tip  22  and into the user&#39;s nasal cavity. When the pump plunger is released, the spring action urges the pump plunger  74  upward closing the check valve  60 . The second spring  78  urges the stopper upward opening the intake hoses  84 ,  86  communication with each separate chamber  30 ,  32 . A vacuum is created in the pump housing  70  as the plunger  74  moves upward, and fluid medicaments from each chamber  30 ,  32  are drawn into the pump housing  70  of the respective pumps  50 ,  52 . While this occurs, the check valves  60  prevent liquid medicament in the reservoir from passing back into the pumps  50 ,  52  from the receptacle  40  or adjacent pumps  50 ,  52  or chambers  30 ,  32  thereby minimizing cross contamination. Although the needle type check valve  60  employed in this embodiment is preferred, a variety of types of valves employing flaps or ball-like valves could also be employed. 
     The receptacle  40  attaches to the apex of each plunger tip (top of the pump). It contains a minimal low volume capacity to reduce storage of mixed medicaments in between nasal spray actuations. In the preferred embodiment the volume of the receptacle can be approximately 5-10 μl. This volume is far less than the volume of the individual pumps. The metered volume of medicament delivered by each pump  50 ,  52  will typically be about 50-100 μl. The receptacle  40  also serves as part of the housing of the micro check valve  60 . The needle head  66  of the check valve  60  moves into the receptacle  40  with each pump action. The nozzle  20  of the spray contains a stylet  24  to minimize volume dead space, increase spray pressure and reduce storage of mixed medicament as well. 
     Several variations of collapsible or even rigid chambers may be employed in accordance with this invention.  FIG. 3  shows a second spray apparatus  102  employing rigid closed chambers  130  and  132 . A liquid tight wall  112  separates and creates the two chambers  130  and  132 . Medicaments from each chamber are removed by the metered pumps  150  and  152 . The piston pumps  150  and  152  can be identical to the pumps  50  and  52  employed with the embodiment of  FIG. 1 . 
       FIGS. 4A-4D  show a third version  202  employing a collapsible syringe configuration including two syringe chambers  230  and  232 . Stoppers  280  and  282  having an air/fluid interface moves vertically through a column formed by syringe chambers  230  and  232  as the medicament fluid is consumed. The stopper position as seen in  FIG. 4A , when visualized though a semitransparent chamber walls that may serve as a indicator meter as well. The individual syringe chambers  230  and  232  can be located in an outer bottle that can also be transparent, or the syringe chambers can be located on the exterior of the device. Pumps  250  and  252  are positioned between the two syringe chambers  230  and  232  as seen in  FIGS. 4C and 4D . In this embodiment, conduits  284  and  286  run from each pump  250 ,  252  to each chamber  230 ,  232  and ultimately joins the top of each chamber as shown in  FIG. 4C . The conduits  284  and  286  extend along the exterior of corresponding chambers  230 ,  232  from openings located on top of each syringe chamber. These conduits are positioned along the external sides of the respective syringe chamber to the bottom of the respective piston type pump  250 ,  252 . The connection of the conduits  284  and  286  to the pumps  250  and  252  is shown in  FIG. 4D . Negative pressure generated with each pump action pulls the stoppers  280 ,  282  vertically towards the top of each chamber  230 ,  232  as the medicaments are dispensed from the inlets at the top of each corresponding chamber  230 ,  232  as seen in  FIG. 4A . Each chamber would have been filled with liquid medicament in the absence of air. In  FIGS. 4A-4D , both pumps are positioned between the chambers for space conservation purposes. A single spray nozzle  220  is mounted on the top of a housing containing a receptacle  240  in which the medicaments initially mix and which provides a passage to the spray tip  222 . The reservoir of the receptacle  240  also provides space for check valves  260  and  262 . The spray nozzle  220 , the reservoir  240  and the check valves  260 ,  262  operate in the same manner as discussed with respect to the embodiments of  FIGS. 1 and 3 . The same corresponding components shown in  FIG. 2  can also be employed in the embodiment of nasal spray device  202  shown in  FIGS. 4A-4D . 
       FIG. 5  illustrates an alternate embodiment of a nasal spray apparatus employing a single pump  350  to pump medicaments from two chambers  330 ,  332 . This embodiment can be employed with medicaments that may be mixed in small amounts and retained for a period of time since a certain amount of mixed medicaments reside in the pump between actuations of the spray device. Conduits  384  and  386  communicate between the two chambers  330 ,  332  that are separated by water tight rigid walls  312  and  314  and check valves  360  and  362  on each side of the conduits  384 ,  386 . Excessive cross-contamination is prevented by employing check valves  360 ,  362  that open and close the conduits  384 ,  386  providing an intake from each chamber  330 ,  332 . A single receptacle  340  provides space for initially mixing the medicaments prior to entering a pump  350 . A balloon capacitor  342  in the form of an expandable sleeve is located between the pump  350  and the receptacle  340  to compensate for back pressures generated by the pump  350  when the check valves  360 ,  362  close. The balloon capacitor  384  expands as the pump  350  is actuated to dispense mixed fluid-medicament residing in the pump  350  through the spray nozzle  320  into the user&#39;s nasal cavity. When the spray nozzle  320  is released, a negative pressure is generated within the pump  350 , and this negative pressure causes the check valves  360 ,  362  to open. Medicaments from each chamber  230 ,  232  can then be drawn into the mixing reservoir  340  and then into the pump  350 , where a metered dose of the mixed medicaments will be retained until the pump  350  is again actuated by depressing the spray nozzle  320 . 
       FIG. 6  illustrates another embodiment in which each medicament is kept separate by means of any combination of the previous mentioned embodiments. In this embodiment two medicaments are not mixed in a reservoir. Instead the two medicaments are expelled through a system of multiple separate passages  426  and  428  extending through a nozzle spray tip  420 . In this embodiment, intakes  426 A and  428 A are connected to the output from separate pumps, such as pumps  50 ,  52  in  FIG. 2 . The still separate medicaments are then separately dispensed through passage openings  426 B and  428 B into the user&#39;s nasal cavity. 
     The preferred embodiment of this invention shown in  FIG. 1  has been successfully fabricated and tested. While specific embodiments of the present invention have been disclosed above, it will be appreciated that the invention is subject to modifications and variations within the broad scope of the invention. Therefore the present invention is defined in terms of the following claims and is not limited to the representative embodiments depicted and discussed herein.