The present disclosure relates generally to a device for dispensing a mist of an ophthalmic liquid fluid. Such devices are already known and vary in structure and design. By way of example, devices are known that comprise a squeeze bottle squeezed by the user to expel the liquid fluid as a mist.
U.S. Pat. No. 3,934,585 A shows a method and apparatus for applying therapeutic eye drops to the eye by metering a predetermined volume of fluid and rapidly applying a pressure to one end of the metered fluid for forcing the fluid from a nozzle.
US patent application 2002/161344 A shows a device and use method for ejecting a liquid stream towards an eye. The device includes a pump mechanism operable to deliver at least part of the liquid from a container through the opening to form a stream of liquid. The pump mechanism may include a pump driver able to store cocked energy for driving the pump mechanism and at least one activation mechanism may be present and operable to initiate the device for the liquid delivery, whereby a driving mechanism is arranged to transform manual or stored energy into cocked energy.
U.S. Pat. No. 5,997,518 shows a device and method for delivering small microliter volumes of liquid preparations to the eye or other body part. The device and method introduces a volume of treatment liquid into an air stream and delivers the liquid in the form of small droplets to the desired site. In contrast to U.S. Pat. No. 5,997,518 A the device according to the present disclosure includes a dosing chamber, for delivering doses of the liquid fluid to a fluid chamber from which a single dose is dispensed by the action of air expelled from an air chamber.
The present disclosure seeks to overcome problems with the prior art dispensers, without compromising the need to provide a simple and user friendly dispenser which allows for repeated discharge of a dose of a medical ophthalmic fluid. In particular, the present disclosure provides a device which is simple to use in allowing a ready dispensing for treatment of both eyes of a person. At the same time, through the disclosure it becomes possible to dispense the ophthalmic liquid fluid irrespectively of the user holding his head upright or tilted, or even if the user is in bed lying down.
Specifically, according to the first aspect as defined broadly in claim 1 device comprises a discharge opening for said mist, a mixing chamber communicating with a discharge opening, an air chamber, a first drive operable to expel air from the air chamber, a fluid chamber for holding a first volume of the liquid and communicating with the mixing chamber, a dosing chamber for containing a second volume of the liquid corresponding to a plurality of the doses, preferably to two doses, of the liquid, the dosing chamber communicating with or configured for communicating with a supply of the liquid, such as a collapsible liquid container or a liquid container having a movable bottom, and with the fluid chamber, a second drive operable to supply the second volume of the liquid from the supply to the dosing chamber and for emptying the dosing chamber by repetitive delivery of a single dose of the plurality of doses of the liquid contained therein to the fluid chamber, the air chamber communicating with the mixing chamber and/or with the fluid chamber for the expelled air to drive the liquid delivered to the fluid chamber into the mixing chamber by the expelled air.
The particular embodiment defined in claim 2 allows the user to obtain a very fine mist of the fluid required where the fluid has a high viscosity and concentration, as may be the case in certain applications and for treating certain ophthalmic diseases or conditions, such as dry eyes, requiring the deposition of low to high viscosity fluid on a person's cornea. Thus, fine, or relatively fine, droplets are achieved even where a liquid fluid of medium viscosity, such as in the order of 1-100 mPa·s is dispensed, through the action of a dedicated air flow, while according to another aspect a repeated discharge of identical doses is made possible.
It is also contemplated to include a mechanism allowing for a user to bring the device into a configuration ready for dispensing using little or a minimum of manual force, which may be required where to device is to be used by eg. an elderly person. For that purpose the device may further comprise a rotatable head or handle, the pistons of the device being moved by rotation of the handle.
Embodiments of the present disclosure are defined in the dependent claims, the objects of which will appear from the following.
A presently preferred embodiment of the disclosure will now be described with reference to
When later herein discussing the present disclosure reference will be made to any common or similar features shown in
Certain features discussed with reference to
Like the prior device shown in
The device 1 of the present disclosure may as shown in
The prior device 1 shown in
In the device 1 according to the present disclosure, as discussed later with reference to
Turning to the prior device,
The component structure 50 comprises inter alia a container or barrel 70 containing the ophthalmic liquid fluid to be dispensed as a mist, and a first drive for user controlled advancing of a piston 55 with a piston rod and a head (the head not being visible in
The cylinder 60 is configured for storing a first volume of air in an internal air chamber when the piston 55 is in a first, normally fully retracted position. The barrel 70 preferably has a movable bottom 72 and/or may be collapsible, has an internal volume allowing for dispensing of multiple doses of the ophthalmic fluid, and may be replaceable to allow for replacement with another and, hence, continued use of the device 1 after one barrel 70 has been emptied.
For the reason explained below, in the prior device 1 the rod of the piston 55 is preferably held against rotation about its longitudinal axis and is generally movable to its first, retracted position from a second, advanced position shown in
In the prior device 1 shown in
Specific for the prior device 1 of
The peristaltic pump 82 includes a housing with a peripheral wall portion 87, shown as a semi-circular wall portion 87, as well as a rotatable disc 84 carrying on the one hand a handle 26 for manually operating the pump 82 and on the other hand two radially oppositely lodged shoes or rollers, of which one roller 86 is seen best in
The peristaltic pump 82 may be provided with, integrally or not, not shown valve means configured for hindering flow of liquid fluid when the peristaltic pump 82 is passive.
The prior device 1 may be configured such that the first drive and the peristaltic pump 82 may be activated and/or retracted by means of one button or handle only; eg. the device head 28 and the handle 26. Furthermore, the device 1 may be configured such that first and/or the peristaltic pump 82 may be activated and/or retracted and/or released by means of applying a linear force to a pushbutton.
Turning to
In the first position of the piston 55 of the prior device 1 shown in
As shown in
As the piston 55 is displaced by the user towards the retracted first position by rotation of the rotatable head 28, air is simultaneously drawn into this air chamber 58 through an air access port. The discharge opening 25 for discharging the mist may be used for this purpose; however, to reduce the risk of contamination of the air chamber 58 by already dispensed liquid fluid being drawn back in together with fresh air the air access port is preferably located elsewhere, such as in the peripheral wall of the cylinder 60 and is preferably equipped with a one-way valve (not shown). Another not shown one-way valve may be located in connection with the discharge opening 25 to prevent or restrict air entry, to prevent the aforementioned contamination. In this manner there is a reduced need for using liquid fluids with preservatives.
The dispensing structure 90 is preferably inserted into the cylinder 60 to define the foremost end thereof, opposite the rear closure 62. As shown, a passage 91 for a first air flow leads from the air chamber 58 into an internal liquid chamber 92 within the structure 90. One or more secondary passages 97, such as three, preferably winding (eg. spirally) around the dispensing structure 90 as in the shown embodiment, are formed and arranged to communicate with the air chamber 58 on the one hand and with a mixing chamber 95 on the other hand. The mixing chamber 95 is located in front of the dispensing structure 90 and defined between the dispensing structure 90 and a front casing part 23 that has an aperture defining the discharge opening 25. The one or more secondary passages 97, which may have circular cross-section(s), allow for a second air flow to flow past the structure 90 and, hence, the liquid chamber 92, i.e. not through the liquid chamber 92, to enter the mixing chamber 95.
The dispensing structure 90 may be provided with a laterally oriented port or passage to allow for a liquid flow to the internal liquid fluid chamber 92 from the second portion 81′ of the tube 80 via connection point 81″, and also has a discharge opening 93 opposite the passage 91. The mixing chamber 95 may, as shown in
The volume of the liquid fluid chamber 92 corresponds to the aforementioned volume of the dose of liquid fluid dispensed or dosed by the peristaltic pump 82 of the prior device 1 upon correct manipulation thereof, i.e. proper rotation of the disc 84 through a given angle, by means of handle 26, and may by way of example be in the order of about 50 mm3. The passage 91, opening 93 and fluid chamber 92 may have a circular cross-section.
When preparing the prior device 1 for use after a previous discharge/dispensing or when taking the device 1 into use for the first time, a person will fill the fluid chamber 92, in the prior device 1 using the peristaltic pump 82, and also withdraw the piston 55 to the retracted, first position. This may, in principle, occur in any sequence, or simultaneously if a single operating part is used for the peristaltic pump 82 and the piston 55. In
On subsequent release of the first drive, in the shown embodiment constituted by the spring 61 which advances the piston 55, air in the air chamber 58 drawn into the cylinder 60 during the preceding withdrawal of the piston 55 is forced out of the cylinder 60 into the liquid fluid chamber 92 within the structure 90 through the passage 91, and preferably also leaves the cylinder 60 as the aforementioned second air flow through the series of additional passages 97 opening up into the mixing chamber 95. The terms “first” and “second” used in this respect are not intended to imply any necessary time wise delay between the two flows of air but primarily to reflect that several flows of air are generated, normally having different purposes, the first air flow primarily serving to force liquid fluid out of the liquid fluid chamber 92. After all liquid fluid has been forced/driven out of liquid fluid chamber 92 any remaining air in the air chamber 58 may still be discharged into the mixing chamber 95 through the liquid fluid chamber 92, to flush the fluid chamber 92.
Turning now to
In other embodiments, as defined broadly in claim 1, the air chamber 58 may be configured to communicate only with the mixing chamber 95, i.e. not directly with the fluid chamber 92, so that liquid is drawn into the mixing chamber 95 by air through a venturi effect only, or to communicate only with the fluid chamber 92 so that liquid is driven into the mixing chamber 95 solely by the effect of the air flowing into the fluid chamber 92, purging all liquid therein.
The rotatable head 28 of the device 1 has a tubular extension 28′ and is configured for snap-engagement with the casing in the area of a shelf 500 which has a central aperture for receiving the tubular extension 28′ and which has downwardly protruding sockets 501, 508 for receiving the upper part of various piston rod assemblies discussed further below. Projecting below the shelf 500 the tubular extension 28′ is provided with a peripheral toothing (not shown) engaged with respective toothing of a first drive operable to draw in air into the air chamber 58 and to expel that air and a second drive operable to supply a second volume, corresponding to two or possibly more doses, of the liquid from a supply to a dosing chamber having a corresponding capacity and for emptying the dosing chamber by repetitive delivery of single doses towards the fluid chamber 92.
On energizing or activating the first drive, such as by rotating the head 28, the air piston head 54 is first displaced to a most retracted position, shown in
Shown to the left in
On energizing or activating the second drive, such as by rotating the head 28 and simultaneously energizing or activating the first drive in the manner described above, engagement with the toothing on the tubular extension 28′ of the head 28 brings about a rotational movement of the liquid piston 155, displacing it, at the same time, first to a most retracted position away from the bottom structure B while compressing the spring 161. The second drive, the operation of which will also be described later, further comprises, or is supplemented by, a hold and release mechanism 130 for holding the liquid piston 155 in one of two different positions until release, the spring 161 operating to drive the liquid piston 155 forwards in two steps, timed by the user activating the release mechanism, each forward movement towards the structure B of the liquid piston 10 from the most retracted position resulting in a dose being delivered to fluid chamber 92, as explained below.
Operation of the device 1 starts with both piston heads 54, 154 is the most advanced, forward position close to the bottom structure B, for the liquid piston as shown in
During this displacement, the respective piston heads 54, 154 move away from the bottom structure B, drawing liquid into the liquid chamber 100 from the fluid supply 70 through conduit 302 and air into the air chamber 54 through any suitable passage formed in the cylindrical wall 60, wherein such suitable passage may preferably be provided with a one-way valve.
The cam surfaces 168, 868 are each followed by a stepped control surface which includes two steps 169 and 170, and two steps 869 and 870, respectively. The stepped control surfaces are so adapted that when the handle 28 has been fully rotated, such as by 180°, and stopped by a stop device (not shown), past the near-end position of the projections 158, 858 shown in
The device 1 in the condition shown in
The user will now want to apply the ophthalmic fluid to the other eye, for which he manipulates once again the hold-and-release mechanism to rotate now the lower part 157′ of the liquid piston rod assembly such that projection 158 thereof moves past the second step 169 of the dosing chamber casing 160 to its original position, at the same time driving the remaining dose in the dosing chamber 100 into the empty fluid chamber 92, cf.
Rotation of the piston assemblies to bring the projections 158, 868 out of engagement with the corresponding steps may be by pressing several times a tab 30 as shown in
It will be understood that the speed of the second flow of air leaving the air chamber 58 is preferably high and that the first flow of air discharged by the action of the spring 61 ejects or pushes the liquid fluid out from the liquid fluid chamber 92 through the discharge opening 93 at the forward end of the liquid fluid chamber 92, into the mixing chamber 95. Flow of the liquid fluid into the mixing chamber 95 may be assisted by any venturi effect arising from the inflow into the mixing chamber 95 of the secondary air flow. A fine mist of the liquid fluid is generated, even where the fluid has a medium to high viscosity, by the second air flow leaving the secondary passages 97 impinging on the simultaneously ejected liquid fluid, in front of the discharge opening 93.
It is contemplated to design the course of the one or more passages 97 such that the forward second air flow preferably strikes the ejected liquid fluid at an acute angle with respect to the general forward direction of flow of the ejected liquid fluid. The fine mist generated thereby exits the device 1 through the discharge opening 25 with high inertia, as determined i.a. by the spring 61, towards the eye of the user, which eye is held open by the eyelid opener portion 10. By properly adjusting the volume of air in the air chamber 58 it may be ensured that all dispensed fluid is blown away from the device 1 during each dispensing.
By selecting the relative dimensions of the one or more passages 97 in relation to the dimension of passage 91 leading into the liquid fluid chamber 92 and the discharge opening 93 leading out there from any desired flow and droplet size may be obtained. It may in some instances be preferred that the liquid fluid is ejected into a second flow of air already prevailing in the mixing chamber 95. The design of the discharge opening 25, normally located about 20-30 mm from the eye when the device 1 is correctly held, ensures that the mist is deposited only on the eye, and this may be achieved with the device 1 held in any orientation, horizontally or vertically.
The container 70 may, in one embodiment, constitute a collapsible bag or pouch made eg. from thin and/or flexible foil; possibly closed by welding. Alternatively, the container 70 may constitute a moulded plastic component.
The container 70 may, in one embodiment, constitute a cylinder including a movable piston. The movable piston may define the bottom of the cylinder and the distal fixed end may be provided with means for hydraulic and/or mechanical interface to the device 1. Means, such as a spring 71, may be provided in order to urge or push the piston into the cylinder. By this, liquid dosing may be facilitated.
The container 70 may, in one embodiment, be joined to a preferably moulded plastic component allowing for hydraulic and/or mechanical interface to the device 1.
The liquid container 70 may be integrated with the wet part of the device 1, preferably in a manner allowing for exchangeability of the container 70.
The separate container 70 may have a unique shape for mechanical orientation and/or fixation of the container with respect to the device 1.
All components of the devices mentioned above may be of any desired material, such as a plastics material, a metal material or combinations thereof. Notably, the collar for keeping the user's eyelid open may carry a surface material with antibacterial properties or be formed from such a material. Furthermore, the components and/or surfaces defining and/or surrounding the discharge opening 25 and/or nozzle may be made from a material with antibacterial properties. Additionally, the material defining the inside surface of the fluid chamber 95 may have hydrophobic properties to assist in discharging all liquid held therein.
As can be seen the device 1 of the shown embodiment of the present disclosure has a relatively flat casing 20, such as one with a length and width in the order of about 90 mm and 60 mm, respectively, allowing it to be conveniently held by the user.
Additionally, when the supply container 70 is empty or nearly empty and safe delivery of a dose can no longer be performed an electronical or mechanical system (not shown) may be provided either to monitor the number of activations of the handle 28 or the remaining content of liquid in the container 70. The mechanical system may be configured to block the movement of the handle. In one embodiment, an element connected to and driven by the handle 28 is fitted with a protruding tab, and the element increments its position at each operation of the handle 28; when the accumulated number of increments corresponds to the available number of doses the protruding tab stops against a stop to block further movement of the handle 28 until reset, such as when a new container 70 is inserted into the device 1.
While it may be preferred to configure the device according to the disclosure such that first and second flows of air are established, which may be preferred where the liquid fluid has a high viscosity, in other cases it may not be required to provide for a secondary flow of air, by configuring the discharge opening 25 as a nozzle suitable for establishing by its geometry alone a small droplet size of the liquid fluid dispensed by the first drive, such as by incorporating a fine mesh structure. For the purpose of the present disclosure, dispensing of doses preselected in the range of 6 μl-40 μl is considered highly relevant.
The following aspect, preceding the claims section, is provided herewith as support for the possible filing of a divisional patent application:
The disclosure relates to a device for dispensing a mist of an ophthalmic fluid, the device comprising a discharge opening for said mist, a mixing chamber communicating with a discharge opening, an air chamber, a first drive operable to expel air from the air chamber, a fluid chamber for holding a first volume of the liquid and communicating with the mixing chamber, a dosing chamber for containing a second volume of the liquid corresponding to a plurality of the doses, preferably to two doses, of the liquid, the dosing chamber communicating with or configured for communicating with a supply of the liquid, such as a collapsible liquid container or a liquid container having a movable bottom, and with the fluid chamber, a second drive operable to supply the second volume of the liquid from the supply to the dosing chamber and for emptying the dosing chamber by repetitive delivery of a single dose of the plurality of doses of the liquid contained therein to the fluid chamber, the air chamber communicating with the mixing chamber and/or with the fluid chamber for the expelled air to drive the liquid delivered to the fluid chamber into the mixing chamber by the expelled air.
Number | Date | Country | Kind |
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PA201570504 | Aug 2015 | DK | national |
This application is a U.S. National Stage of International Application No. PCT/EP2016/067414 filed on Jul. 21, 2016, which claims priority to Danish Patent Application No. PA201570504 filed on Aug. 4, 2015. The entire contents of these applications are incorporated herein by reference.
Filing Document | Filing Date | Country | Kind |
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PCT/EP2016/067414 | 7/21/2016 | WO | 00 |