Multi medication nasal spray device and method

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'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.

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.

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 referringFIG. 1, the preferred embodiment of a nasal spray apparatus2of the present invention is illustrated. In this embodiment there are two collapsible chambers30,32in a surrounding rigid vented, but not necessarily air tight, housing or bottle10. The venting of the housing or bottle10prevents a vacuum from developing in the housing10. Each chamber30,32is drained by a metered pump50,52and has a sack, bag or bladder-like form that collapses as the liquid medicament is consumed or transported. The bottle or housing10may include an internal wall separating the two chambers. The chambers30,32are preferentially vertically oriented. As seen inFIG. 1, each pump50,52is connected to a single shared receptacle40formed in a spray nozzle20. The receptacle40houses a check valve60for each pump50,52and provides a conduit where two medicaments are initially mixed as the medicaments enter the spray nozzle20. As seen inFIGS. 1 and 4, the receptacle40provides spaces42,44for clearance for the check valves60to move from the closed position shown inFIG. 1to an open position. Receptacle40also includes an internal passage46connecting spaces42,44and a passage48leading to the spray tip22of spray nozzle20. The nasal spray apparatus2can be activated by the user in the same what that a user would actuate a conventional nasal spray devices. The spray nozzle20is merely depressed relative to the bottle10to dispense the contents into the nasal passages of the user.

FIG. 2shows details of components for pumps50,52, receptacle40and spray nozzle tip22that can be employed with the embodiment ofFIG. 1as well as with other embodiments to be subsequently discussed in more detail. Each pump50,52includes a pump housing70, a vented plunger74with a plunger neck54, stoppers80or82and two springs76,78. 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 housing70contains 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 plunger74that is fenestrated. The fenestration allows for the passage of medicaments to leave the pumps50,52and pass through the check valves60. Each check valve60comprises a check valve needle66and a check valve seat62. The apex of the plunger is covered with a check valve needle64that slides in and out of the fenestration of the plunger74and into the receptacle40with pump action. This makes up a micro check valve configuration. The pin64has a smaller diameter than the opening or fenestration in the top of the plunger74. Each check valve60includes a head66from which the pin64extends. When the check valve60moves to the open position shown inFIG. 2, the valve pin head66is spaced from a valve seat62on the top of the plunger74so that liquid medicament can flow through the opening between the check valves60and their respective seats62. This particular feature of the pump design is unique. When depressing the pumps50,52, the check valve needle64rises and opens the check valve60to allow for medicament to pass from the pumps50,52into the receptacle40. The medicaments from each chamber30,32are forced through the respective pumps and into the receptacle40during the down stroke of the pump plunger74. First spring76forces the stopper80, or82down to close off the respective intake hose84or86, leading to chambers30,32, during the down stroke, so that only direction in which the liquid medicament previously stored in the pump housing70can flow is out the top of the respective piston pumps50,52. After multiple medicaments are mixed in the receptacle40, the medicaments are forced through the spray nozzle tip22and into the user's nasal cavity. When the pump plunger is released, the spring action urges the pump plunger74upward closing the check valve60. The second spring78urges the stopper upward opening the intake hoses84,86communication with each separate chamber30,32. A vacuum is created in the pump housing70as the plunger74moves upward, and fluid medicaments from each chamber30,32are drawn into the pump housing70of the respective pumps50,52. While this occurs, the check valves60prevent liquid medicament in the reservoir from passing back into the pumps50,52from the receptacle40or adjacent pumps50,52or chambers30,32thereby minimizing cross contamination. Although the needle type check valve60employed in this embodiment is preferred, a variety of types of valves employing flaps or ball-like valves could also be employed.

The receptacle40attaches 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 pump50,52will typically be about 50-100 μl. The receptacle40also serves as part of the housing of the micro check valve60. The needle head66of the check valve60moves into the receptacle40with each pump action. The nozzle20of the spray contains a stylet24to 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. 3shows a second spray apparatus102employing rigid closed chambers130and132. A liquid tight wall112separates and creates the two chambers130and132. Medicaments from each chamber are removed by the metered pumps150and152. The piston pumps150and152can be identical to the pumps50and52employed with the embodiment ofFIG. 1.

FIGS. 4A-4Dshow a third version202employing a collapsible syringe configuration including two syringe chambers230and232. Stoppers280and282having an air/fluid interface moves vertically through a column formed by syringe chambers230and232as the medicament fluid is consumed. The stopper position as seen inFIG. 4A, when visualized though a semitransparent chamber walls that may serve as a indicator meter as well. The individual syringe chambers230and232can be located in an outer bottle that can also be transparent, or the syringe chambers can be located on the exterior of the device. Pumps250and252are positioned between the two syringe chambers230and232as seen inFIGS. 4C and 4D. In this embodiment, conduits284and286run from each pump250,252to each chamber230,232and ultimately joins the top of each chamber as shown inFIG. 4C. The conduits284and286extend along the exterior of corresponding chambers230,232from 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 pump250,252. The connection of the conduits284and286to the pumps250and252is shown inFIG. 4D. Negative pressure generated with each pump action pulls the stoppers280,282vertically towards the top of each chamber230,232as the medicaments are dispensed from the inlets at the top of each corresponding chamber230,232as seen inFIG. 4A. Each chamber would have been filled with liquid medicament in the absence of air. InFIGS. 4A-4D, both pumps are positioned between the chambers for space conservation purposes. A single spray nozzle220is mounted on the top of a housing containing a receptacle240in which the medicaments initially mix and which provides a passage to the spray tip222. The reservoir of the receptacle240also provides space for check valves260and262. The spray nozzle220, the reservoir240and the check valves260,262operate in the same manner as discussed with respect to the embodiments ofFIGS. 1 and 3. The same corresponding components shown inFIG. 2can also be employed in the embodiment of nasal spray device202shown inFIGS. 4A-4D.

FIG. 5illustrates an alternate embodiment of a nasal spray apparatus employing a single pump350to pump medicaments from two chambers330,332. 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. Conduits384and386communicate between the two chambers330,332that are separated by water tight rigid walls312and314and check valves360and362on each side of the conduits384,386. Excessive cross-contamination is prevented by employing check valves360,362that open and close the conduits384,386providing an intake from each chamber330,332. A single receptacle340provides space for initially mixing the medicaments prior to entering a pump350. A balloon capacitor342in the form of an expandable sleeve is located between the pump350and the receptacle340to compensate for back pressures generated by the pump350when the check valves360,362close. The balloon capacitor384expands as the pump350is actuated to dispense mixed fluid-medicament residing in the pump350through the spray nozzle320into the user's nasal cavity. When the spray nozzle320is released, a negative pressure is generated within the pump350, and this negative pressure causes the check valves360,362to open. Medicaments from each chamber230,232can then be drawn into the mixing reservoir340and then into the pump350, where a metered dose of the mixed medicaments will be retained until the pump350is again actuated by depressing the spray nozzle320.

FIG. 6illustrates 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 passages426and428extending through a nozzle spray tip420. In this embodiment, intakes426A and428A are connected to the output from separate pumps, such as pumps50,52inFIG. 2. The still separate medicaments are then separately dispensed through passage openings426B and428B into the user's nasal cavity.

The preferred embodiment of this invention shown inFIG. 1has 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.