One way valve assembly

CA 02628331 2008-05-02

WO 2007/055922

PCT/US2006/041840

ONE WAY VALVE ASSEMBLY

CA 02628331 2008-05-02

WO 2007/055922 PCT/US2006/041840

BACKGROUND OF THE INVENTION

The present invention is directed to a one way valve assembly for dispensing a sterile flowable substance while preventing any backflow of contaminants into the source of the flowable substance. The valve assembly includes a valve body enclosed by a pressure displaceable flexible member or elastomeric member for effecting the passage of the flowable substance to a controllable outlet while preventing any backflow to the source of the flowable substance after dispensing individual portions of the flowable substance.

In the past, to maintain the flowable substance free of contaminants, preservatives have been mixed in the flowable substance in the container from which it is to be dispensed. The use of preservatives is an added expense and tends to limit the effectiveness of the flowable substance, particularly when the flowable substance is a pharmaceutical such as an eye care solution or it is a food stuff.

Another consideration is the ability of the valve assembly to deliver a selected amount to the outlet without causing any damage to the user, such as when applying an eye care solution directly into the eye.

CA 02628331 2008-05-02

WO 2007/055922 PCT/US2006/041840

In recent years, flexible membranes have been used to control the flow of the flowable substance-to the valve assembly outlet while preventing any backflow to the source of the flowable substance, however, it has been difficult io provide an effective procedure for manufacturing the valve assembly and limiting its costs.

SUMMARY OF THE INVENTION

Therefore, the primary object of the present invention is to provide a valve assembly for conveying a flowable substance from a closed source, such as a collapsible container while preventing any backflow of contaminants through the valve assembly into the source of the flowable substance after a portion of the substance has been dispensed.

The collapsible container can be a bellows type, a tube, an internal bag or other type of collapsible form designed to dispense practically all of its contents. The container has a normally closed controllable outlet surface for dispensing a flow of the flowable substance out of the valve assembly. The container is in sealed contact with the valve assembly so that its contents do not receive any contaminants when the flowable substance is dispensed.

CA 02628331 2008-05-02

WO 2007/055922 PCT/US2006/041840

Dispensation of the flowable substance is effected by applying pressure to the container so that its contents flow to the valve assembly. The contents may be a pharmaceutical, such as an eye care solution or other substance which must be kept free of contaminants during dispensing a multiple number of dispensed amounts. Other flowable substances can be food stuffs or beverages, cosmetics, or other flowable substances intended to be maintained free of contaminants during the dispensing operation. The container may be protected by a housing so that pressure is not accidentally applied.

The valve assembly is an axially extending structure open to the container of the flowable substance. The valve assembly is formed of an axially extending inner core open to the container and formed of a rigid plastic component. The interior of the core has a passageway for receiving the flowable substance from the container. At least one port extending from the passageway affords an opening for conveying the flowable substance out of the inner core.

Tightly enclosing the inner core is an axially extending flexible membrane covering the outlet end of the port through the inner core. The flexible membrane moves outwardly from the inner core when the flowable

CA 02628331 2008-05-02

WO 2007/055922 PCT/US2006/041840 substance is pressurized and passes through the port and flows toward the outlet end of flexible membrane.

Laterally outwardly from the flexible membrane is a valve cover ending in the controllable outlet orifice. The pressurized flowable substance travels between the radially outwardly extended flexible membrane and the outer surface of the inner core and flows to the controllable outlet orifice. The outlet orifice can provide for a limited amount of the flowable substance to be dispensed.

An over cap covers the exterior of the valve cover to protect the valve assembly during storage, and to avoid accidental dispensing.

A collar joins the valve assembly to the container and affords a sealed arrangement preventing any flow of contaminants into the container.

The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operation, advantages and specific objects attained by its use, reference should be had to the accompanying drawings and descriptive matter in which there are illustrated and described a preferred embodiment of the invention.

CA 02628331 2008-05-02

WO 2007/055922

PCT/US2006/041840

<td></td><td> BRIEF DESCRIPTION OF THE DRAWINGS:</td>

<td> Fig. 1</td><td> is an axially extending view of a one way valve assembly embodying the present invention;</td>

<td> Fig. 2</td><td> is an exploded view of the one way valve assembly shown in Fig 1;</td>

<td> Fig 3a</td><td> is an enlarged axially extending partial view of the one way valve assembly in the at rest position;</td>

<td> Fig 3b</td><td> is a partial view similar to Fig 3 a, however, with the one way valve assembly in the dispensing position; and</td>

<td> Fig 4</td><td> is an enlarged partial axially extending view of the dispensing end of the one way valve assembly shown in Fig 3b.</td>

CA 02628331 2008-05-02

WO 2007/055922 PCT/US2006/041840

DETAILED DESCRIPTION OF THE INVENTION

As shown in Fig. 1 the one way valve assembly 1 is composed of a bellows container or source 2 holding a sterile flowable substance, a valve assembly 3 for conveying the flowable substance from the container 2 to an outlet when pressure is applied to the container 2 and an over cap 15 covering the valve assembly 3 to prevent contamination from entering the valve assembly 3 during storage.

The bellows container 2 collapses when pressure is applied to the container, however, other containers may be used such as a tube or an internal bag in a container which permit multi-dose dispensation of the flowable substance without contamination entering the container following the dispensing procedure.

The flowable substance may be a pharmaceutical, such as a eye care solution, a food stuff, such as products or juices, and a cosmetic, such as a skin care solution or toiletries, and liquid vitamins, all of which are intended to be maintained free of contaminants from the ambient atmosphere.

The bellows container or source 2 is laterally enclosed by an axially extending housing 6 to provide better ergonomic control during dispensing. A

CA 02628331 2008-05-02

WO 2007/055922 PCT/US2006/041840 slot 7 extending axially in the housing 6 permits a user to gain access to an actuator 2a of the container as the flowable substance is pressed out.

A collar 8 connects the valve body 3 to the container 2 affording a scaled connection so that ambient contaminants cannot pass into the container 2.

The valve assembly 3 has an axially extending inner core 10 bearing against the opening of the container 2 so that flow from the container enters into an axially extending blind passageway 11 in the inner core. The passageway 11 extends for a major portion of the axial length of the inner core. At approximately half the length of the passageway 11 the inner core has at least one port 12 extending transversely of the passageway axis from the surface of the passageway to the outer surface of the inner core 10. The inner core 10 is formed of a rigid plastic material and terminates inwardly of the outlet end of the valve body.

A flexible membrane 13, such as an elastomeric member, is fitted tightly over the outer surface of the inner core and extends from the opening in the container 2 to the opposite end of the inner core 10. As can be noted in Figs. 2a and 2b, the thickness of the membrane is variable along its axial length and in the region of the outlet end of the inner core has an axially extending

CA 02628331 2008-05-02

WO 2007/055922 PCT/US2006/041840 continuous uninterrupted annular band considerably thicker than the remainder of the flexible membrane 13, that is, the band is not separated in the axial direction by axially extending cuts.

At its end adjacent the opening from the container, the flexible membrane 13 has an outwardly extending flange bearing against a flange on the inner core is located at the opening from the container.

An axially extending valve cover 14 encircles the flexible membrane 13 and as shown in the rest position in Fig 2a is spaced radially outwardly from the outer surface of the flexible membrane. The end of the valve cover 14 adjacent the container 2 has a radially outwardly extending flange 14a bearing against the flange at the end of the flexible membrane effecting the seal for the valve body at the opening from the container 2.

The valve cover 14 is formed of an inner layer of an elastomeric material extending axially from its flange 14a to and over the outlet end of the valve body 3. The elastomeric material forms a soft cover 7 over the outlet end of the increased thickness which is particularly advantageous when the valve assembly is used for dispensing an eye care solution. Such a soft cover 7 prevents any damage to the eye.

CA 02628331 2008-05-02

WO 2007/055922 PCT/US2006/041840

The soft cover 7 has an outlet orifice 7a for dispensing the flowable substance. The outlet orifice is closed in the rest position of the one way valve assembly, however, when the flowable substance is being dispensed and exits the outlet end of the flexible membrane, it flows radially inward to the outlet orifice which then opens allowing the substance to flow out of the valve assembly. When the flowable substance is dispensed and pressure on the source is withdrawn the outlet orifice 7a closes blocking any backflow into the valve assembly.

By selectively dimensioning the outlet orifice 7a a drop-like amount of the flowable substance can be dispensed, for example if an eye care solution is being dispensed. If a greater amount of the flowable substance is to be dispensed the outlet orifice 7a can be formed for dispensing a larger quantity of the flowable substance. The outer orifice 7a can be formed to provide a spray or a stream of the flowable substance.

An over cap 15 is placed over the valve assembly when it is not in use protecting it from contact with ambient contaminants and for unintended dispensing.

io

CA 02628331 2008-05-02

WO 2007/055922 PCT/US2006/041840

When the flowable substance is to be dispensed, the over cap 15 is removed and pressure is applied to the actuator 2a of the container so that an amount of the flowable substance passes out of the container into the passageway 11 in the inner core 10. The substance flows through the ports at least one port 12 and expands the flexible membrane 13 radially outwardly and flows toward the outlet end of the flexible membrane where it exits from the flexible membrane radially inwardly into the outlet orifice 7a in the cover and is dispensed.

By releasing the pressure on the actuator 2a of the container, the dispensing operation is terminated and the flexible membrane 13 returns inwardly into contact with the outer surface of the inner core 10. The inward movement of the flexible membrane start at its outlet end because of its increased thickness and affords gradual contact with the outer surface of the inner core returning any flowable substance through the ports back into the container whereby contaminants cannot enter the container.

Dispensing individual portions of the flowable substance can be continued until the container is almost completely emptied.

CA 02628331 2008-05-02

WO 2007/055922 PCT/US2006/041840

As mentioned, a variety of pharmaceuticals, cosmetics, food stuffs and other flowable materials can be dispensed where it is important to maintain them free of contaminants from the ambient atmosphere. The flowable characteristics of the material being dispensed determines the type and dimension of the valve body.

The material forming the outlet orifice 7a does not absorb the flowable substance, any substance entering the outlet orifice is ejected and does not return into the space between the inner core and the flexible membrane.