WO1998011852A1

WO1998011852A1 - Fluid dispenser

Info

Publication number: WO1998011852A1
Application number: PCT/EP1997/005178
Authority: WO
Inventors: Ian Michael Dennis Gaylor; Nicholas Andrew Murray Drought; Christopher John Andrew Barnardo; Lucy Anita Rowbotham
Original assignee: The Boots Company Plc
Priority date: 1996-09-18
Filing date: 1997-09-18
Publication date: 1998-03-26
Also published as: GB9619444D0; AU4460397A

Abstract

There is disclosed a device for applying fluid to a substrate, the device comprising a hollow shaft (1) attached to which is a hollow head (9), the shaft holding a volume of fluid (5), the head having a dispensing chamber (13) with an aperture (15) therein, the aperture being surrounded by a resilient, absorbent material (11) capable of absorbing fluid; the interior of the shaft and the head being fluidly connected only through a capillary tube (17), such that when the shaft is squeezed fluid is drawn up by capillary action through the tube into the dispensing chamber from where the fluid slowly diffuses from the aperture into the absorbent material to be dispensed. Preferably the shaft may comprise a resilient, plastically deformable material capable of being deformed by finger pressure to aid dispensing of fluid from the absorbent head.

Description

FLUID DISPENSER

The present invention relates to the field of devices for dispensing fluid and in particular to those for dispensing fluid to the surface of the eye.

Eye hygiene is important as the visual sense is the sense from which we obtain the most information about our environment and yet the eye is a delicate organ. Therefore, it is desirable to provide means to wash and irrigate the eye to remove irritants which collect over time. It is particularly useful in environments where the eye could be subject to splashes from corrosive chemicals, swarf or the like. It may also be desirable to apply fluid to the eye for other reasons (e.g. to soothe the eye and/or as a medicament).

Fluid compositions may be administered ocularly in known forms for such administration (for example water-miscible, fluid compositions [optionally administered as drops, sprays or aerosols]). Fluid compositions suitable for ocular administration may comprise soothing agents, wetting agents and/or suitable pharmaceutically active agents to treat (by therapy or prophylaxis) suitable diseases and/or disorders whether directly of the eye (e.g. glaucoma) or systemically.

Lotions or other fluids which may be applied to the eye to wash and irrigate the eye and/or for other (e.g. therapeutic) reasons may comprise dilute aqueous solutions of salts such as sodium chloride which are isotonic with lachrymal secretions and may also comprise a pH adjusting agent (for example a borate phosphate salt buffer) to maintain the pH of the eye lotion within a particular pH range (for example 5 to 8).

Fluids can be difficult to apply to the eye with traditional methods such as eye droppers, which also compromise the sterility of the fluid even when prepared under sterile conditions. Eye droppers are messy to use as the head of the user must be facing upwards so the eye socket is approximately horizontal The user is also deterred from using eye droppers because the end of the dropper which is hard may contact the eye directly which is both uncomfortable, off-putting to the user and potentially dangerous

Therefore there is a need to develop an alternative means of delivering fluid to the eye which is as cheap and readily disposable as a conventional dropper, is more effective in use, and is not wasteful of fluid and/or messy to use Preferably the device should contain the fluid so there is no messy filling of the device prior to use, which has the added advantage that the device may be portable if required and may be kept by the user in a bag or pocket prior to use

Therefore it is an object of the present invention to overcome some or all of the aforementioned disadvantages and to produce a device which has some or all of the desirable features described herein The applicant has developed a device which delivers fluid to the eye and has some or all of the preceding advantages and overcomes some or all of the problems associated with the prior art

A device suitable for use in applying fluid to a surface, the device comprising a hollow shaft attached to which is a hollow head, the shaft holding a volume of fluid, the head having a dispensing chamber with an aperture therein, the head being surrounded by a resilient, absorbent mateπal capable of absorbing fluid, the interior of the shaft and the head being in fluid communication only through a capillary tube, whereby when the shaft is squeezed fluid is supplied through the tube into the dispensing chamber from where the fluid to be dispensed diffuses from the aperture into the absorbent material

Preferably the shaft may comprise a resilient, plastically deformable material capable of being deformed by finger pressure to aid dispensing of fluid from the absorbent head. More preferably the shaft comprises a plastics material such as polyvinylchloride (PVC).

Preferably the absorbent head comprises an absorbent spongy foam-like material, more preferably EPE and/or polyurethane cellular foam.

Preferably to keep the device sterile it is sealed in a sterile pack, optionally transparent. More preferably the dispensers are stored in a hinged box with a clear lid to display the dispensers.

The precise amount of any active ingredient or ingredients administered to the eye surface using the device described herein will depend on a number of factors. Such factors may comprise any or all of the following: the specific compound or compounds administered and/or their intended use; the particular clinical condition being treated (if any) and/or its severity; and the age, body mass and/or past clinical history of the patient using the device. In any event the amount of active ingredient or ingredients administered to the eye lies within the sound discretion of the person administering and/or supervising use of these devices (if any) such as a pharmacist, medical practitioner [for example nurse and/or physician] and/or veterinary.

Nevertheless a suitable daily dose of an active ingredient or ingredients for ocular administration to a patient is generally from about 0.01 mg/day per kg of the patient's body mass to about 100 mg/kg/day given in a single dose and/or in divided doses at one or more times during the day. The total dose of the active ingredient or ingredients administered per day may be generally from about 0.1 mg to about 5000 mg. Fluids suitable for ocular delivery may comprise from about 0.1 ng/ml to about 100 mg/ml of the active ingredient or ingredients. If the active ingredient or ingredients comprise a salt the masses indicated above refer to the mass of the corresponding active ingredient that is other than a salt. Typically a device according to the present invention might have a storage chamber of about 1 ml in volume and dispense a single dose of fluid.

Although the dispensers of the present invention have particular utility in dispensing sterile fluids especially, but not exclusively, to the eye, they should not be considered limited to such a use and are suitable for dispensing any fluid of suitable viscosity in a controlled manner to any surface whether to a biological subject or any other suitable substrate, especially those substrates which are particularly sensitive or where a delicate touch is required (for example applying cleaning or other fluids to old and/or priceless artefacts such as archaeological finds and works of art such as paintings).

A method of making a device suitable for use in applying fluid to a surface comprising the steps of: a) filling a resilient and elastically deformable tube closed at one end, with the fluid to be dispensed, b) inserting in the tube a wire-like form for a capillary tube, c) sealing the tube about the form spaced from the closed end entrapping the fluid in the tube thus to form a fluid reservoir and spaced from an open end of the tube to form a dispensing chamber open at one end, d) withdrawing the wire-like form to leave a capillary tube in fluid connection with the reservoir and the dispensing chamber, e) surrounding the dispensing chamber with an absorbent resilient material, and f) fixing the material thereto and shaping it to form a head for the dispenser, through which fluid may be dispensed in a controlled manner.

Preferably the tube is sealed using ultrasonic means.

Optionally the dispenser is made in sterile conditions and may be wrapped in a sterile pack. A non-limiting specific embodiment of the present invention will now be described with reference to the following example and the drawings in which:

Figure 1 shows one embodiment of a dispenser according to the present invention;

Figure 2 is a detailed view of a section through the head of the dispenser shown in Figure 1 ;

Figures 3 to 10 show the sequence of steps in a method of making the dispensers shown in Figures 1 and 2.

Referring to Figures 1 and 2, the dispenser comprises a hollow shaft (1) comprising walls (3) made from PVC which define a fluid reservoir (5) containing the sterile fluid (7) to be dispensed. Attached to one end of the shaft

(1) is a head (9) comprising a polyurethane cellular foam (11) enclosing a dispensing chamber (13). This chamber (13) comprises an aperture (15) so it is in fluid communication with the exterior of the dispenser through the surrounding foam (11). The chamber is also in fluid communication with the interior of the otherwise closed reservoir (5) in the shaft (1) via a capillary tube

(17) through an otherwise sealed portion (19) of the shaft. The dimensions of the capillary tube depend on the viscosity of the fluid to be dispensed. If the fluid is Optrex ® the capillary tube typically has a diameter of 200 μm and a length of 3 mm.

To use the dispenser, finger pressure is applied to the deformable shaft walls (3) to increases the pressure of the fluid (7) within the reservoir (5). Squeezing the shaft (1) forces some of the fluid (7) to flow through capillary tube (17) into the dispensing chamber (13) and up onto the foam tip (11), slowly diffusing into the absorbent mateπal. It is believed that fluid drawn up by capillary action continues to be drawn up through the tube (17) as the fluid diffuses into the foam tip (11 ). Thus the foam tip (11) of the dispenser can be used to apply small amounts of sterile fluid (7) to a surface in controlled manner. This is particularly useful for sensitive regions of the body. For example if fluid is Optrex ® the dispenser can be wiped in or around the region of the eye to cleanse and/or refresh the eye.

Figures 3 to 10 illustrate a preferred embodiment of a method of making the dispensers of the present invention. Figure 3 shows a cross section of a blank tube (21) made from PVC by dip or injection moulding. This tube will form the walls (3) of the hollow shaft (1) of the dispenser and is open at one end through aperture (15). Figure 4 shows the tube (21) being filled in sterile conditions through aperture (15) with a suitable sterile fluid (7) such as Optrex ® using a hollow lance (23) connected to a source of the fluid (7). Figure 5 illustrates the next step in which a thin whisker (25) is inserted to form the mould for the capillary tube (17). The whisker (25) is made from any suitable material for example a 0.2 mm diameter wire made of a nickel / titanium alloy. In Figure 6 the walls (3) of the tube (23) are ultrasonically welded together about the whisker (25) in a region near the aperture (15) above the level of the fluid (7) using ultrasonic probes (27). This forms a closed reservoir (5) containing fluid (7), the sealed region (19) and the open dispensing chamber (13), open through aperture (15 ). In Figure 7 the whisker (25) is removed from the sealed region (19) in the direction of the arrow to leave capillary tube (17) connecting reservoir (5) to chamber (13) . A sheet of polyurethane cellular foam (11) is folded over the dispensing chamber (13) as shown in Figure 8. The foam (11) is heat sealed to the shaft (1) and die cut to an appropriate shape to form the head (9) as shown in Figure 9. The completed dispenser may be optionally wrapped in a sterile pack (29) preferably made from a transparent material such as clear PET flowrap, as shown in Figure 10.

Claims

CLAI S

1. A device suitable for use in applying fluid to a surface, the device comprising a hollow shaft attached to which is a hollow head, the shaft holding a volume of fluid, the head having a dispensing chamber with an aperture therein, the head being surrounded by a resilient, absorbent material capable of absorbing fluid; the interior of the shaft and the head being in fluid communication only through a capillary tube, whereby when the shaft is squeezed fluid is supplied through the tube into the dispensing chamber from where the fluid to be dispensed diffuses from the aperture into the absorbent material.

2. A device as claimed in claim 1 , in which the shaft comprises a resilient, plastically deformable material capable of being deformed by finger pressure to aid dispensing of fluid from the absorbent head.

3. A device as claimed in either preceding claim, in which the fluid is sterile.

4. A device as claimed in claim 3, in which the sterile fluid is suitable for application to the eye.

5. A device as in any preceding claim wherein the resilient absorbent material is a spongy foam-like material.

6. A sealed package comprising a device according to any preceding claim enclosed within a sterile sealed package.

7. A method of delivering a fluid using a device as claimed in any preceding claim.

8. A method as claimed in claim 7, in which the fluid is sterile.

9. A method as claimed in claim 8, in which the sterile fluid is delivered to the eye.

10. A method of manufacture of a device as claimed in any preceding claim comprising assembly of the constituent parts thereof.

11. A method of making a device suitable for use in applying fluid to a surface comprising the steps of: a) filling a resilient and elastically deformable tube closed at one end, with the fluid to be dispensed, b) inserting in the tube a wire-like form for a capillary tube, c) sealing the tube about the form spaced from the closed end entrapping the fluid in the tube thus to form a fluid reservoir and spaced from an open end of the tube to form a dispensing chamber open at one end, d) withdrawing the wire-like form to leave a capillary tube in fluid connection with the reservoir and the dispensing chamber, e) surrounding the dispensing chamber with an absorbent resilient material, and f) fixing the material thereto and shaping it to form a head for the dispenser, through which fluid may be dispensed in a controlled manner.