The present invention relates to a fluid dispensing apparatus. The present invention also relates to a method of manufacturing a fluid dispensing apparatus. There are a many known ways to deliver a dosage of medication to a user, these include oral delivery, transdermal delivery or intravenous delivery. The meaning of 'medication' within this disclosure should be understood as including any therapeutic, prophylactic or any diagnostic agents. Delivering a dosage of medication orally allows medication to be delivered directly to a user's lungs. Such delivery to a user's lungs has proven to be effective in treating many respiratory diseases, such as Cystic Fibrosis, Asthma and Chronic Obstructive Pulmonary Disease.

There are numerous types of asthma treatment available, one of which is an inhaler. Inhalers are used to orally deliver a measured dosage of asthma medication directly to the user's lungs. There are many different types of inhaler devices, including: pressurised Metered Dose Inhalers (MDIs) and dry powder inhalers.

MDI inhalers are normally quick to use, relatively small and convenient to transport and keep on one's person. They are also relatively inexpensive.

Different types of medications have different chemical and mechanical properties. To ensure that the medication is effectively dispersed into a patient's mouth by the inhaler, the design of such inhalers may require alternate design geometries depending on the medications used.

Typically, when manufacturers are looking to improve the dispersion characteristics of an inhaler, the re-design of the internal parts responsible for the dispersion of the fluid is of key focus. Current practice when altering the design of a fluid dispensing device is to decide on the new geometry of design and then fabricate a mould capable of producing the new fluid dispensing device. This enables the production of a prototype of the new fluid dispensing device which can then be inserted into an inhaler outer casing to test the system and investigate how the dispersion characteristics are affected by the new design. Despite this being an effective method of testing a new inhaler design, the production of the new moulds in this process is time consuming and costly.

l The present invention aims to alleviate at least to a certain extent the problems of the prior art, alternatively to provide a useful fluid dispensing apparatus and/or methods of manufacturing the same.

Accordingly, the present disclosure provides a method of manufacturing a fluid dispensing apparatus comprising the steps of forming a body. The body comprises an orifice, which is configured to allow a fluid to be dispensed from the fluid dispensing apparatus. Once the body is formed, the orifice is formed using orifice forming means.

Forming the body and then the orifice in this way provides a method that enables the manufacture of a plurality of bodies which can then be provided with orifices of different geometries using the orifice forming means. This advantageously enables a person to quickly, inexpensively and efficiently test a number of different orifice geometries to find how fluid dispersion (flow characteristics) is affected.

Preferably, the method includes providing the body of the fluid dispensing apparatus with a chamber which is configured to be in fluid communication with the orifice. Providing the fluid dispensing apparatus with a chamber advantageously provides a volume to receive fluid before it is dispensed from the orifice.

Preferably, the method includes providing the body with a module which is configured to be in fluid communication with the orifice. The module may optionally be provided with receiving means to receive a fluid or at least a part of a container which is containing a fluid. Advantageously, providing the body with the module allows the fluid dispensing apparatus to have more complex internal and/or external geometry which would not be obtainable if the body was formed from one piece of material.

The receiving means may be of any geometric shape which enables it to receive a fluid or at least a part of a container which is containing a fluid. Preferably, the method includes providing the body and/or the module with displacement limiting means to limit the displacement of the container. In this way the displacement limiting means restricts the displacement of, for example a canister, preventing it from travelling further towards the orifice.

Preferably, the body and the module are secured together in any suitable way. Chemical adhesion, screws or bolts are a few examples of ways of securing them together. Preferably, the method includes providing the body and/or the module with alignment means to align the body and the module when in fluid communication. The alignment means may comprise at least one raised platform and corresponding depression(s) for the at least one raised platform into which the raised platform fits. The alignment means advantageously helps to align the module and the body in the correct position relative to one another and prevents them from moving relative to one another when the fluid dispensing apparatus is in use.

Preferably, the components of the fluid dispensing apparatus are formed by Computer Numerical Control (CNC) machining. Using a CNC machine to form the components of the fluid dispensing apparatus for a relatively small batch of apparatuses advantageously enables quick and accurate manufacture of the components and relatively inexpensively compared to producing the same apparatus via a moulding process.

Preferably, the orifice is formed by machining. For example, the orifice may be machined using a milling machine and/or a drilling machine. Alternatively, the orifice may be formed using an orifice punching machine.

Preferably, the inside surface of the orifice is machined to form a textured surface, for example to form a rifled orifice surface, or to form spirals, ribs, spiral ribs etc. within at least a part of the orifice. For example the orifice may have one or more helical grooves or ribs extending along it. Machining to create textured surfaces inside the orifice in this way advantageously gives a variety of different orifice geometries which have beneficial fluid dispersion characteristics. Forming such textured surfaces via moulding processes can be very difficult, if possible at all.

Preferably, the components of the fluid dispensing apparatus are manufactured from any suitable material, for example a polymer or a metallic material. More preferably, the fluid dispensing apparatus components are manufactured out of poly (methyl methacrylate) (PMMA). Even more preferably, if PMMA is used, the PMMA is transparent.

Preferably, the method includes providing the chamber and/or the alignment means with vertical walls.

Preferably, the drilling machine and/or the milling machine used to manufacture the apparatus has an accuracy of ±0.001 mm to ± 1 mm, more preferably an accuracy of < ±0.01 mm. Preferably, the method includes providing the fluid dispensing apparatus with at least one securing means configured to enable the fluid dispensing apparatus to be coupled with at least one external member, either reversibly coupled or irreversibly coupled, and coupled such that the fluid dispensing apparatus is held in a substantially stationary position relative to the external member.

Preferably, the method includes providing the fluid dispensing apparatus with a diffuser which is in fluid communication with the orifice.

Preferably, the diffuser may have a tapered section, or at least a part of the diffuser has a tapered section. Preferably, the method includes providing the apparatus with a tapered orifice, or at least a partly tapered orifice.

According to another aspect of the present disclosure, there is provided a fluid dispensing apparatus comprising a body. The body comprises an orifice which is configured to allow the fluid to be dispensed from the fluid dispensing apparatus, wherein the orifice is machined. Preferably, the body comprises a chamber which is in fluid communication with the orifice.

Preferably, the body of the fluid dispensing apparatus comprises a module which is in fluid communication with the chamber.

Preferably, the module comprises receiving means to receive a fluid or at least a part of a container which contains a fluid. Preferably, the body and/or the module comprise displacement limiting means to limit the displacement of the container.

Preferably, the body and the module are secured together in any suitable way. Chemical adhesion, screws or bolts are a few examples of ways to secure them together.

Preferably, the body and the module comprise alignment means to align the body and the module. More preferably the alignment means comprise at least one raised platform and corresponding depression(s) for the at least one raised platform into which the raised platform fits. The alignment means may optionally be provided with vertical walls.

Preferably, the components of the fluid dispensing apparatus are manufactured of any suitable material, for example, a polymer or a metallic material. More preferably, the fluid dispensing apparatus components are manufactured out of poly (methyl methacrylate) (PMMA). Even more preferably, if PMMA is used, the PMMA is transparent.

Advantageously, using a transparent material allows one to observe whether there has been any attrition of the internal parts of the components during use. Preferably, the orifice is machined to an accuracy of ±0.001 mm to ± 1 mm. Even more preferably to an accuracy of < ±0.01 mm

Preferably, the fluid dispensing apparatus comprises at least one securing means configured to enable the fluid dispensing apparatus to be coupled with at least one external member either reversibly or irreversibly coupled, and is coupled such that the fluid dispensing apparatus is in a substantially stationary position relative to the external member.

Preferably, the fluid dispensing apparatus may be provided with a diffuser which is configured to be in fluid communication with the orifice.

Preferably, the diffuser has a tapered section.

Preferably, the apparatus includes a tapered orifice. Preferably, the orifice is machined using a milling machine or drilled using a drilling machine. Alternatively, a combination of milling and drilling may be used to form the orifice. Alternatively, the orifice may be formed using an orifice punching machine.

Preferably, the inside surface of the orifice is machined to form a textured surface, for example to form a rifled orifice surface, or to form spirals, ribs, spiral ribs etc. within at least a part of the orifice. For example, the orifice may have one or more helical grooves or ribs extending along it.

The fluid dispensing apparatus may be for dispensing liquid and/or gaseous fluid and it is also envisaged that in some embodiments the fluid dispensing apparatus may be for the fluid-like flow of particulate matter or provides such as medicament powders, or of liquid and/or gaseous matter including particulates such as such powders.

According to another aspect of the present disclosure, there is provided a method of manufacturing a medical dispensing device such as an inhaler which includes manufacturing a fluid dispensing device by carrying out a method as set out above, and installing the fluid dispensing apparatus in a main body of the medical dispensing device. This may be used for a prototyping function or in mass production. According to another aspect of the present disclosure, there is provided a method of manufacturing a first medical dispensing device which includes manufacturing another fluid dispensing apparatus by carrying out a method as set out above, testing the flow characteristics through the orifice of the another fluid dispensing apparatus, and then forming the first medical dispensing device with an orifice substantially the same shape and size as the tested orifice of the fluid dispensing apparatus.

Preferably, the medical dispensing device is a valve stem block.

According to another aspect of the present disclosure, there is provided a method of forming an inhaler which includes a medicinal dispensing device, which may comprise a valve stem block, in accordance with the previous aspect hereof.

Preferably, the inhaler is provided with a medicinal canister, which is installed inside a main body of the inhaler.

The present invention may be carried out in various ways and a preferred embodiment of a method of manufacturing a fluid dispensing apparatus in accordance with the invention will now be described by way of example with reference to the accompanying drawings, in which:

FIG. 1 - Is a perspective view of a preferred embodiment of a fluid dispensing apparatus;

FIG. 2 - Is a perspective view showing a cross section through a fluid dispensing apparatus;

FIG. 3 - Is a perspective view of a fluid dispensing apparatus located inside a mouth inhaler; FIG. 4 - Is a perspective view of a fluid dispensing apparatus located inside a mouth inhaler; and

FIG. 5 - Is an exploded view of the parts of FIG. 3 and FIG. 4 together with a medicinal canister containing pressurised fluid for inhalation.

Detailed description A fluid dispensing apparatus is shown in FIG. 1 generally at item 2. The particular fluid dispensing apparatus shown in FIG. 1 (and also FIG. 2) is of the type that may be employed as a component in an inhaler typically used in the medical industry for dispensing a dose of fluid medication. An example of the positioning of the fluid dispensing apparatus within an inhaler is illustrated in FIG. 3 and FIG. 4. The uses of the fluid dispensing apparatus as described herein or method of manufacturing thereof is not limited to an application for use solely in inhalers. The fluid dispensing apparatus of the present invention could, for example, be used for fluid dispensing in syringes or other industrial applications which would benefit from such an apparatus. For example the fluid dispensing apparatus may be for a metered dose inhaler of the type using a pressurised canister with a metering valve for releasing metered doses. However other embodiments may be employed with other types of inhaler, atomisers, (oral nasal or cosmetics for example) or injection pens or other medical or laboratory apparatus.

As can be seen from FIG. 1 and FIG. 2, the fluid dispensing apparatus 2 comprises a body 4 and a module 10. The body 4 and module 10 form a valve stem block for a valve stem 50 of a canister 52 of the type known for use in pressurised fluid metered dose inhalers. The valve stem 50 is insertable into the cylinder 12 - See FIG. 5.

The illustrations of the apparatus in FIG. 1 and FIG. 2 show only one possible variation of the fluid dispensing apparatus; it is possible that the body 4 and the module 10 be integrally formed or separate from one another in a different configuration.

The module 10 sits on top of the body 4. In order to align the module 10 and the body 4 in the correct positions relative to one another, the body 4 has a raised platform 18 which is of a D-shape. The module 10 has a D-shaped depression 19 on its bottom surface which corresponds to the raised platform 18. The platform 18 and the depression 19 fit together in a male/female fashion such that a snug fit is achieved.

The snug fit between platform 18 and depression 19 may form a water-tight or air-tight connection. In certain applications, e.g. where such a water-tight or air-tight connection is not required, a substantially water-tight or air-tight or a non-water-tight or non-air-tight connection may be used. The raised D-shaped platform 18 may alternatively be of any other shape or geometry which would allow the body 4 and module 10 to align with one another. Having only one line of symmetry, the D-type shape ensures that the module 10 can be placed onto the body 4 in one orientation. The shape of platform 18 preferably has only one line of symmetry in a similar way to the D-shape shown in FIG. 1 and FIG. 2.

Module 10 may be secured to body 4 in any suitable way, for example chemical adhesion, heat welding, ultrasonic welding, bolts, screws, nails etc... In the embodiment shown in FIG. 1 and FIG. 2 the body 4 and module 10 are secured together by way of a screw 16 which is screwed through an orifice 15, which runs through module 10 and body 4.

The module 10 comprises a truncated cone 14b on its top surface which is in fluid communication with cylinder 12. Cylinder 12 is in fluid communication with a reservoir 6 in the body 4. The truncated cone 14b acts to limit the downwards displacement of fluid medication containers which are being displaced in the direction of the body 4, which may be loaded inside an inhaler to which the fluid dispensing apparatus is employed.

The truncated cone shape 14b on the top of module 10 is not limited to a truncated cone shape as shown in FIG. 1 and FIG. 2 and may alternatively take any other suitable shape. Similarly, the cylinder 12 is not limited to the shape shown in FIG. 1 and FIG. 2 and may take any other suitable shape.

Cylinder 12 may be shaped in a way that it receives a part of a fluid container or valve of a container. The body 4 comprises a reservoir 6 which acts to receive a dosage of fluid medication. Reservoir 6 is of sufficient size to accommodate a required dosage of medication. The body also comprises an orifice 8 which is in fluid communication with the reservoir 6. The orifice 8 is located substantially near the end of the reservoir 6 which is furthest from the module 10 and is of a suitable geometry to allow a fluid which has entered the reservoir 6 under pressure to flow through it at a rate which causes dispersion of the fluid.

Although FIG.1 and FIG. 2 show there to be reservoir 6 present within body 4 for holding fluid, optionally body 4 does not have a reservoir 6 to hold fluid. If this is the case, the fluid may, for example, be dispersed directly from the fluid container through orifice 8 which is in fluid communication with orifice 8. The reservoir 6 as shown in FIG. 1 and FIG. 2 may take any suitable shape. The orifice 8 may be located anywhere within the reservoir 6.

The orifice 8 may be of any suitable geometry and may vary depending upon the application of the fluid dispensing apparatus, for example the orifice may be circular, rectangular, etc. in cross-section. The walls of the orifice 8 may be substantially smooth, substantially rough or barrelled. The orifice shape or size may vary along its length. For example it may be tapered, for example becoming wider or narrower towards an outlet end. The orifice 8 may be of any dimensions, for example if the orifice 8 is circular and cylindrical, the diameter of the cross-section may be 0.20 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm, 0.25 mm, 0.26 mm, 0.26 mm, 0.27 mm, 0.28 mm, 0.29 mm, 0.3 mm, 0.31 mm, 0.32 mm, 0.33 mm, 0.34 mm, 0.35 mm or any other suitable size.

The geometry of the orifice 8 may be selected in such a way that it transfers the desired effect to the fluid travelling through it. For example, some applications may require that the fluid to be dispersed in such a way that the fluid is atomised, partially atomised or not atomised at all.

In fluid communication with orifice 8 is diffuser 22. The geometry of diffuser 22 comprises a truncated cone section 22a and a cylindrical section 22b (downstream of the truncated cone section 22a considered in a direction of fluid flow), which are in fluid communication with each one another and also orifice 8. The diameter of orifice 8 is smaller than the reduced diameter end of the truncated cone 22a. The diameter of the cylindrical section 22b is the same as the larger diameter of the truncated cone 22a. One end of the cylindrical section 22b is in communication with truncated cone 22a and one end is on surface 28.

The diffuser 22 shown in FIG. 1 and FIG. 2 comprising the truncated cone section 22a and cylindrical section 22b may alternatively have any suitable geometry to provide different fluid dispersion effects. For example, the shape of the diffuser 22 may be similar to that of a Venturi tube.

The body 4 of the fluid dispensing apparatus has a series of orifices 20a, 20b and 20c which are located on surface 24. Orifices 20a and 20b follow a cylindrical path perpendicular to surfaces 24 and 28 towards surface 28 into the body 4 but do not reach surface 28. Orifice 20c follows a cylindrical path perpendicular to surfaces 24 and 28 into the body 4 and meets surface 28. The orifices 20a, 20b and 20c are provided to accommodate an external securing member (not present in the figures) to enable the body 4 to be secured in a fixed position inside an inhaler casing 100. The orifices 20a, 20b and 20c are not limited to the location, number of orifices and geometries as shown on FIG. 1 and/or FIG. 2. A purpose of the orifices 20a, 20b and 20c is to secure the apparatus 2 in a fixed position inside an inhaler casing 100. There may therefore be any number of orifices 20a, 20b and 20c in any location on the apparatus, on either the body 4 and/or the module 10, and on any surface and having any geometry which enables them to perform their function. The orifices 20a, 20b and 20c may for example be angled in relation to axis A. In other embodiments, the orifices may be omitted and the fluid dispensing apparatus may be attached to an inhaler casing 100 by welding or other means of fastening. The body 4 has angled wings 32 and 34 on surfaces 26 and 30. Angled wings 32 and 34 allow the fluid dispensing apparatus 2 to sit in correct alignment inside an inhaler casing as shown in FIG. 3. Angled wing 32 is of a different geometry to angled wing 34 so that their position on the body 4 creates an asymmetric footprint on the fluid dispensing apparatus 2. An asymmetric footprint allows the fluid dispensing apparatus 2 to align with the inhaler casing in only one way.

The geometries of the angled wings (or supports) 32 and 34 are not limited to the geometries shown in FIG. 1 and FIG. 2. The angled wings 32 and 34 may be of any suitable shape. There may alternatively be either one or more than two angled wings. The angled wings 32 and 34 may alternatively be shaped to form a symmetric footprint which may or may not allow the fluid dispensing apparatus 2 to align with the inhaler casing in only one way.

The fluid dispensing apparatus 2 of the present disclosure may be used in a variety of applications; the type of material that the components of the fluid dispensing apparatus are manufactured from are entirely dependent on variables such as: the environment in which the fluid dispensing apparatus is to be used in (for example, temperature, pressure, or forces they will be exposed to during use), chemical composition or abrasive properties of the fluid which the apparatus will be dispensing. The components of the fluid dispensing apparatus 2 (the body 4 and module 10) may be manufactured from the same material or may be manufactured from different materials.

For example, the components of the fluid dispensing apparatus 2 may be manufactured from any suitable material such as metals, polymers or ceramics.

According to an embodiment of the present disclosure there is provided a method for manufacturing a fluid dispensing apparatus, an example of which is shown in FIG. 1 and FIG. 2.

The method of manufacturing the embodiment shown in FIG. 1 and FIG. 2 comprises a number of steps, these steps include:

• Forming the body 4 and the module 10; and

• Securing the body 4 to the module 10. Computer Numerical Control (CNC) machining is used to form module 10, machining the module 10 comprises machining the truncated cone 14b, the cylinder 12, orifice 15 and the depression 19. CNC machining may be used to partially or fully form the body 4 of the fluid dispensing apparatus 2. Machining the body 4 comprises machining from one piece of solid material the reservoir 6, orifice 15, orifices 20a, 20b, 20c, diffuser 22 and angled wings 32 and 34.

The type of machining used to form the module 10 and the body 4 is not limited to CNC machining. Any other suitable methods to form the module 10 and the body 4 may be used, for example 3D printing.

Although in the example embodiment provided in FIG. 1 and FIG. 2 of the fluid dispensing apparatus body 4 and module 10 are separate components, these two components may alternatively be formed out of one piece of material as a single component. Once the body 4 is partially formed, the forming of body 4 is completed by drilling orifice 8 into the centre of diffuser 22 and along Axis A. The forming of orifice 8 is not limited to drilling and may be any other suitable process which would result in forming orifice 8; orifice 8 may alternatively be formed by way of a milling process or by using a combination of milling and drilling processes. The forming of the orifice 8 by machining means that when creating a body 4 for use, such as for testing of orifice size/shape, it is not necessary to make a new mould for the body each time the orifice characteristics are changed. Therefore it is possible to make multiple types of body with different orifices both rapidly and at low cost, for example without having to change the mould used to make the body 4 and/or module 10. Once the orifice has been tested, it is then possible to make medical devices with a fluid dispensing apparatus with an orifice the same shape and size as the tested orifice in volume production. In this case, although the tested orifice has been machined, orifices may be moulded or otherwise formed to the same size during mass production. However, the machining described here may also be used in mass production. The orifice 8 shown in FIG. 1 and FIG. 2 shows that the orifice 8 is in the direction of axis A. However, the orifice 8 is not limited to this vector along axis A and may be, for example at an angle.

The body 4 is secured to the module 10 by way of a screw 16 which is screwed into orifice 15. Screwing the body 4 and module 10 together is only one of many ways that would be suitable to secure the body 4 to module 10. Chemical adhesion, nails, heat treatment, heat welding, ultrasonic welding are some further examples of other ways to secure body 4 to module 10. Once the body 4 and module 10 have been formed, deburring steps may be employed to remove any unwanted pieces of material which are remaining following the machining processes.

The components of the fluid dispensing apparatus may be coated with any number of coatings which act to improve the efficiency of the fluid dispensing apparatus. For example, the surfaces of the fluid dispensing apparatus 2 may be coated with a coating to reduce surface attrition where the fluid dispensing apparatus 2 is used with an abrasive fluid, a coating to improve fluid flow through the fluid dispensing apparatus 2, a coating to increase the life span of the fluid dispensing apparatus 2, a coating to prevent contaminants from entering the fluid to be dispersed by the fluid dispersing apparatus etc...

Various modifications may be made to the described embodiment without departing from the scope of the invention.