EP3166663A2

EP3166663A2 - A masking package

Info

Publication number: EP3166663A2
Application number: EP15738430.6A
Authority: EP
Inventors: Kenneth Simon Aylett Moore
Original assignee: Individual
Current assignee: Individual
Priority date: 2014-07-07
Filing date: 2015-07-07
Publication date: 2017-05-17
Also published as: GB201412065D0; GB201414625D0; GB2528139A; WO2016005740A2; WO2016005740A3

Abstract

A masking package is provided to mask medical or hypodermic syringes or vials for syringes. This sort of masking package may be used in blind drug trials where the participant must not be able to identify the drug being used. The masking package is comprised of an opaque housing (102, 104) and an adaptor element (122) for fixing the syringe or vial into the housing (120. 104). The housing has two portions (102, 104) which can move relative to each other.

Description

A !ViASK!NG PACKAGE

Field of the invention

This invention relates to a masking package designed to mask medical or hypodermic syringes or vials for syringes. This sort of masking package may be used in blind drug trials where the participant must not be able to identify the drug being administered. Syringes often have different shapes or appearances dependent on the drug they contain, so it may be possible to identify a drug being administered from the outward appearance of the syringe. Vials of drugs can be similarly identifiable by size, shape or colour. In a trial of this sort the invention masks syringes or vials containing different drugs so as to mask, disguise or conceal the appearance of the syringe or vial containing the drug or placebo, or being used to administer it.

Background

In biind drug trials it is essential to hide from the patient or trial participant what medication is being administered. This is because participants in drug trials may have personal opinions or biases about the drugs being tested, which may affect their reaction to whichever drug they're given. In order to prevent a participants own knowledge of the drugs being tested or their own expectations affecting the effects of the drugs it is protocol to hide which drug each participant is being administered. The heaith care professional administering the treatment may also affect the outcome of the trial; an effect called observer bias can affect a medical trial just as strongly as the placebo effect. For this reason, it has become essential in many eases to be able to hide the drug in the trial from the administrator as well as the participant in order to assess the efficacy of new drugs without biases.

In order to conceal drug treatments in this way it is therefore necessary to have methods to deliver trial drugs to participants that do not ai!ow the participant or the administrator to see what is being administered. This can often be very difficult as drugs which are already available on the market are often heavily branded and easily identified. Drugs administered via syringes in particular can be very heavily branded as the syringe itself is much more easily modified than a pill or tablet. The shape, size and colour of a syringe can all be used to identify the drug within it; hence there is a need for a method of delivering medication from syringes to participants in blind drug trials without allowing the participant or the

administrator to see the syringe. Syringes used in blind drug trials are typically hypodermic needles, as the majority of liquid medicines are delivered subcutaneously, immediately under the skin, or into the muscle further below the skin.

Disguising or camouflaging hypodermic needles can prove very problematic. As syringes vary so much, there is no known single method of masking them all that still allows them to be used effectively. The plunger of a syringe is especially difficult to mask as they vary widely in size and shape, and must be fully depressable so as to delivery the full contents of the syringe even when masked. It is desirable to make the height, width and range of motion of all syringes appear identical when masked.

It is also common to delivery drugs or placebos for blind drug trials in vials. The medical professional draws the liquid out of the vial into an empty syringe or hypodermic needle for administration. Vials of drugs are often heavily branded and easily identified, similarly to syringes. The shape, size and colour of a vial can be modified, and branding labels can be attached to the outside of the vial.

Prior art

Devices for containing syringes or multiple syringes are known, such as in US application US2008/0108951. However the device in this document is merely a storage system to be used with a variety of syringe devices and does not shield the syringe from view. It also stores the needles and the syringe separately, so these must be assembled before use.

It is known from the prior art to disguise syringes for medicai use, An example of the sorts of masking devices found in the prior art is US application US2002/0082564. This camouflages the syringe and needle from view, but for the purposes of disguising the syringe as a toy to aid drug administration to children. This arrangement is not designed to receive different sizes of syringes.

Summary of the invention

According to a first aspect of the present invention, there is provided a masking package for blind testing of materials stored in a container, comprising: an opaque housing: and an adaptor element for fixing a container to the housing; wherein the housing is formed of a first housing portion and a second housing portion, the adaptor element is configured to be fixed, in use. to a container and an inner surface of the first housing portion, and wherein the second housing portion can, in use, move relative to the first housing portion.

Preferably, the invention is for use in blind testing of medicinal materials. It is drugs and other forms of medication that benefit most from blind trials as biases can affect trials very strongly. A package to improve the masking of different medicinal materials may greatly improve the ease of administering the medication in a blind trial.

Preferably, the invention is for use in blind testing of liquid medicinal materials. Liquids in particular are difficult to mask in a blind trial as devices, such as syringes, are required to administer them. Therefore the package should either mask the syringe or allow access of a syringe to a vial containing a liquid medicinal material. A package to improve the masking of different liquid medicinal materials may greatly improve the ease of administering liquid medication in a blind trial.

Preferably, the first housing portion comprises an opening at a first end and a substantially closed second end with an orifice for receiving a syringe needle, and wherein the second housing portion comprises an opening at a first end and a closed second end. The closed ends of the housing portions may shield the container within from view when assembled, while the orifice allows a needle to pass through, through which the liquid within the container may be accessed. This advantageously allows the liquid to be accessed without requiring opening of the package.

Preferably, the adaptor element has an external major dimension, smaller than the corresponding internal major dimension, in a direction transverse to the longitudinal axis of the first housing, of the first housing portion at the end adjacent to the first open end of the first housing portion, such that the adaptor element is insertable into the first housing portion through said first end of the first housing portion. Allowing the adaptor element to fit within the first housing portion allows the adaptor to securely hold the container within the housing portion.

Preferably, the first housing portion is substantially cylindrical and wherein the second housing portion is substantially cylindrical. Most containers of medicinal liquids are also cylindrical, such as the barrels of syringes or drug vials; hence this should be the most widely useable shape for a masking package.

Preferably, the adaptor element and the first housing portion are configured to retain the adaptor element and the first housing portion substantially in axial alignment. With these elements aligned, the adaptor element should not rotate within the first housing portion, allowing it to hold the container within the first housing portion more securely than if it were free to rotate or tilt.

Preferably, the first housing portion includes a first section configured to receive the adaptor element, and a second section configured to receive at least part of the container, the first housing portion further including a shoulder between the two sections. With separate sections configured to receive different elements, the first housing portion is advantageously designed to hold each element securely. St is not required to have containers and adaptor elements of the same dimension, as the different sections of the first housing portion may adapted specifically for each. Preferably, the adaptor element is configured to abut the shoulder between the two sections when the adaptor element is fixed in the first housing portion. This may prevent the adaptor element from moving excessively within the first housing portion once assembled, as this may damage the container masked within the package.

Preferably, the substantially closed end of the first housing portion fits within the open end of the second housing portion. In this arrangement the second housing portion acts as a lid, advantageously concealing the orifice in the closed end of the first housing portion.

Preferably, the adaptor element, when inserted into the first housing portion, forms a closure of the first open end of the first housing portion. In the arrangement the adaptor element acts as a seal or plug, retaining the container within the assembled package and concealing the container from view if looking through the open end of the first housing portion.

Preferably, an inner surface of the adaptor element includes a projection which, in use, engages with the bottom surface of a container, in order to retain the vial within the masking package. This projection abuts the bottom of the container, holding it in position within the housing. The adaptor portion does not need to be inserted far into the first housing portion in order to abut a vial which is shorter than the first housing portion. It may remain at the open end of the first housing portion acting as a plug or seal, and the projection extends within the first housing portion to reach the bottom of the container where it may secure it.

Preferably, the adaptor element has a projection on an outer surface to retain the adaptor element within the first housing portion. There may be a plurality of point-like projections or a single projection extending around the outer surface of the adaptor element This projection is sufficiently small that it should not prevent the adaptor element being inserted into the first housing portion during assembly.

Preferably, the first housing portion has a recess configured to cooperate with the projection on the outer surface of the adaptor element to retain the adaptor element within the first housing portion. The first housing portion should be sufficiently tight fitting around the projection from the adaptor element that once the projection or projections engage with the recess or groove, as the adaptor element is inserted into the first housing portion, it will require significant force to remove it. This means the adaptor element is advantageously securely held within the first housing portion so should not move if the assembled package is moved or re-orientated.

Preferably, the container is a vial. This is a common container to use in the distribution of medicinal liquids, and it may prove problematic to deliver the contents to a patient or participant without the patient or participant viewing the vial. Hence it is advantageous to provide a masking package that conceals a viai while allowing the contents to be accessed by a syringe needle for administration.

According to a second aspect of the present invention, there is provided a masking package for blind testing of materials stored in a vial, comprising; an opaque housing, comprising an open end for receiving a viai and a closed end having an orifice; and, an adaptor element configured to close the open end of the housing, wherein, in use, the adaptor element is further configured to engage with a vial received in the housing to retain the vial adjacent the closed end of the housing.

Preferably, the adaptor element includes retention means to retain the adaptor element within the housing. This ensures the adaptor element does not drop or fail out of the housing if the assembled masking package is moved or tilted. This retention means may be in the form of a screw thread, St may be a projection or projections engaging with a recess or groove. The adaptor element may be retained externally to the housing. Alternatively it may be retained internally within the housing.

Preferably, the retention means is a projection on an outer surface to retain the adaptor element within the first housing portion. Additionally the first housing portion has a recess configured to cooperate with the projection on the outer surface of the adaptor element to retain the adaptor element within the first housing portion. The housing should be sufficiently tight fitting around the projection from the adaptor element that once the projection or projections engage with the recess or groove, the adaptor element is retained for the purposes of administering the contents of the vial in a blind drug trial,

Preferably, the adaptor element further comprises an inner surface of the adaptor element includes a projection which, in use, engages with the bottom surface of the viai, in order to retain the viai within the masking package. This projection may be a resilient projection. The projection may be a spring. When the adaptor element is inserted into the housing the projection may deform on engagement with the bottom surface of the vial. This

advantageously allows a single adaptor element to be used for vials of different lengths within the same housing.

Preferably, the housing comprises a window for viewing the vial within the housing. This window is located in the circumferential external wall of the hosing, it advantageously allows a user to view the contents of the viai for safety reasons, to ensure a needle withdrawing the contents of the viai is correctly in contact with the contents. Preferably, the masking package further comprises a second housing portion comprising an opening at a first end and a closed second end, wherein the housing fits within the open end of the second housing portion, in this arrangement the second housing portion forms a lid over the housing, covering the orifice. This advantageously protects the top of the via! for hygiene purposes as well as shielding it completely from view.

According to a third aspect of the present invention, there is provided a masking package for a syringe comprising: an opaque housing; and an adaptor element for fixing a syringe to the housing, wherein the housing is formed of a first housing portion and a second housing portion, the adaptor element is configured to be fixed, In use, to a syringe and an inner surface of the first housing portion, the second housing portion includes an inner surface for engaging with the plunger of a syringe, and wherein the second housing portion can, in use, move relative io the first housing portion to engage and actuate the plunger of a syringe fixed to the adaptor element and first housing portion.

Preferably, the adaptor element includes, in a direction substantially transverse to the longitudinal axis of the adaptor element, a projecting shoulder configured to abut the side of a cross piece of a syringe facing away from the plunger when the syringe is fixed to the adaptor element. This shoulder prevents the syringe travelling further into the body of the package than desired. The cross piece of the syringe should not be able to travel past the shoulder or projection or ledge that projects from the walls of the adaptor element towards the central axis.

Preferably, the adaptor element comprises two complementary and inter-engageable portions which combine in assembly around a syringe and define a channel for receiving the cross piece of a syringe. This allows the design of the adaptor element to be simple, and therefore inexpensive to produce. It requires no moving parts to lock, or retain the syringe in place. The cross piece of the syringe is secured within the channel, preventing the syringe moving up and down within the adaptor, and the barrel of the syringe is held between the two halves of the adaptor element, both above and below the cross piece. This is designed to prevent the syringe tilting, or moving in any other way.

Preferably, each portion of the adaptor element includes, in a direction substantially transverse to the longitudinal axis of the adaptor element, a channel defined by one or more projecting shoulders, such that when the two portions of the adaptor element are assembled, the one or more projecting shoulders of each portion of the adaptor element abut to form a channel to receive and retain the cross piece of a syringe. In one embodiment, the adaptor element has a first shoulder and a second shoulder, wherein the surfaces of each shoulder face each other to form the channel. In this embodiment, the channel formed when the two portions of the adaptor element are assembled is a single continuous channel. These are again very simple components, which are inexpensive to manufacture. The faces of the portions of the adaptor element that abut are preferably substantially longitudinal to the axis of the adaptor element. Locating the join between the two portions of the adaptor element in this manner advantageously restricts separation of the two portions once the adaptor element is located within the first housing portion, as the walls of the housing prevent the two portions separating once the package is assembled. The channel being formed of two parts in each portion of the adaptor element allows the adaptor element to be assembled around a syringe, retaining the cross piece to prevent movement of the syringe in use, without the need for complex components or moving parts.

Where the adaptor element comprises two portions, the adaptor element may comprise a connecting mechanism to retain the two portions about a syringe. The connecting mechanism may comprise at least one male portion on one of the adaptor element portions and a corresponding female portion on the other one of the adaptor element portions.

Preferably, each adaptor element portion includes a male portion and a female portion. In a particularly preferred embodiment, each adaptor element portion is substantially identical. Providing substantially identical adaptor element portions may reduce the manufacturing costs, and may reduce the complexity of assembling the masking package.

Preferably, the first housing portion is substantially cylindrical, including an opening at a first end and a substantially closed second end with an orifice for receiving a syringe needle, and wherein the second housing portion is substantially cylindrical, comprising an opening at a first end and a closed second end. These are again very simple components, which are inexpensive to manufacture. Each portion can function with no moving parts to open or close it, so it is very simple to assemble and use. The opening of the first housing portion provides an entrance for the adaptor element with the syringe. The orifice in the substantially closed end of the first housing portion advantageously allows the needle of the syringe to emerge, without providing an opening wide enough for a user to view the contents of the housing when the package is in use. The first housing portion may further include a needle cover to cover the needle of a syringe when it is received in the masking package. The needle cover is preferably removably coupled to the first housing.

Preferably, the open end of one of the two housing portions fits within the open end of the other of the two housing portions such that one of the first and second housing portion is slidable within, and relative to, the other of the first and second housing portion. This provides a very simple arrangement for assembly and use. Preferably, the adaptor element is narrower than a cavity defined by the inner surface of the first housing portion such that the adaptor element is insertable into the first housing portion through a first open end of the first housing portion. Preferably the adaptor element has an external major dimension, in a direction transverse to the longitudinal axis of the adaptor element, smaller than the corresponding internal major dimension, in a direction transverse to the longitudinal axis of the first housing, of the first housing portion at the end adjacent to the first open end of the first housing portion, such that the adaptor element is insertable into the first housing portion through said first end of the first housing portion. In this arrangement the adaptor element holding the syringe can hold the syringe within the first housing portion, and the first housing portion can conceal the barrel of the syringe.

Preferably the adaptor element and the first housing portion are configured to retain the adaptor element and the first housing portion substantially in axial alignment. This arrangement ensures that the syringe held within the package is secured along the axis of the package. Any sideways movement could make administration of the drug or placebo within the syringe less accurate and potentially dangerous.

Preferably, the first housing portion has a projection on an inner surface to retain the adaptor element within the first housing portion. This can prevent the adaptor element from escaping the first housing portion once it is in position. In use, a syringe is rarely only used in one orientation, it must be possible to use it through all orientations and angles as the angle of administration can be very varied depending on the patient or participant. Therefore it is advantageous that the adaptor element is concealed and securely held within the masking package in all orientations The projection may retain the adaptor element. In this position the adaptor element should not move if the masking package is re-orientated.

Preferably, the adaptor element has a recess or groove, configured to cooperate with the projection to retain the adaptor element within the first housing portion. This groove is located around the circumferential wall of the or each portion of the adaptor element. This is very simple method of retaining the adaptor element within the housing. Advantageously both the groove or recess and the projection can be integrally formed with the adaptor element or the first housing portion.

Preferably, the inner surface of the second housing portion includes a projection which, in use, engages with the top surface of a plunger of a syringe held in the package, in order to engage with the plunger of a syringe. This allows the plunger of the syringe to be depressed in use, so as to administer the drug or placebo within the syringe. The projection of the second housing portion allows the second housing portion to be in indirect contact with the plunger when the masking package is assembled, such that the plunger may be depressed while still being concealed.

Preferably, the first housing portion has a window in a wall of the cylinder for, in use, viewing a syringe held within the housing. The window is located in the circumferential, external wall of the first housing portion, This allows the administrator of the drug or placebo to view the contents of the syringe for safety purposes. They can ensure there are no air bubbles in the solution to be administered, and after use can check whether all of the drug or placebo was successfully administered. The window means that these security checks can take place without the need to dissemble the masking package.

The syringe remains within the package and they are discarded together after use. The patient and administrator will not need to see the syringe within the masking package.

Preferably, the first housing portion includes one or more flanges, projecting from an outer surface of the first housing portion, to enable the package to be gripped like a syringe. In one embodiment this flange is located adjacent to the first open end of the first housing portion. This allows the administrator to deliver the drug or placebo to a patient using a single hand similar to when using an un-masked syringe. It also gives the masking package the general appearance of a syringe, which may make it appear less intimidating to a patient than a larger package which needed two hands for administration.

Preferably, the first housing portion includes a first section configured to receive the adaptor element, and a second section, configured to receive a barrel of a syringe, held within the adaptor element, the first housing portion further including a shoulder between the two sections. This shoulder or ledge can hold the adaptor element in position once it has been fully inserted into the first housing portion. It prevents the adaptor element moving further into the first housing portion. The adaptor element must be held securely so that the syringe is held in position, as it could be difficult and potentially dangerous to administer a drug or placebo from the syringe if it was loose within the package and able to move.

Preferably, the adaptor element is configured to abut the shoulder between the two sections when the adaptor element is fixed in the first housing portion. This ensures that the adaptor element cannot pass beyond the shoulder or ledge. Only the needle of the syringe should emerge from the orifice, as any other section of the syringe could be identifiable.

Preferably, the masking package comprises two or more adaptor elements configured to receive the cross pieces of syringes of different sizes. In blind drug trials, where a patient may be due to receive one of two possible treatments, the masking package is designed to make the two possible syringes indistinguishable from each other, such that the patient doesn't know which is being administered. It is therefore advantageous for the external appearance of the masking package to not change, even if it is required to hold syringes of different dimensions. The adaptor element is concealed from view once it is in position within the first housing portion. The adaptor portion may therefore vary in order to accommodate syringes of different sizes and shapes.

Preferably, the masking package two or more second housing portions with projections from the inner surfaces configured to engage with plungers of syringes of different sizes. This also allows syringes of difference sizes and shapes to be effectively masked. The length of plungers of different syringes can vary greatly. Therefore in order to mask the two or more different syringes that may be used in a blind drug trial the masking package have the same outward appearance regardless of the syringe within it. It would also be advantageous to be able to use the syringes in the same manner when masked. For shorter plungers, longer projections within the second housing portion can be used, and similarly for longer plungers, shorter projections or no projections at all. The range of movement of the second housing portion with relation to the first housing portion may be the same regardless of the length of plunger it is concealing, so that a patient or the person administering the drug will not be able to differentiate between different drugs or placebos.

According to a fourth aspect of the present invention, there is provided a method of masking a syringe comprising the steps of: retaining a syringe between two halves of an adaptor element; inserting the adaptor element into a first open end of a first housing portion;

securing the adaptor element within the first housing portion; and positioning a second housing portion in slidable engagement with the first housing portion such that an engagement surface within the second housing portion abuts the plunger of the syringe. This is a quick and simple process. It should not require any expert knowledge. This means that the appropriate syringe for a given patient could be selected and masked by a person not trained in healthcare, before being passed to a medical professional for administration. This should ensure the administrator cannot identify the solution within the syringe. This assembly can also be done in hygienic conditions appropriate for medical trials.

Preferably the method further comprises the step of locking the cross piece of the syringe between two halves of the adaptor element. This ensures that the syringe is securely fixed within the adaptor element and should not move in any direction relative to the adaptor element.

Preferably, the method further comprises the step of inserting the adaptor element into the first housing portion until the point at which the needle of the syringe emerges from an orifice in the first housing portion. This positions the needle in the optimum site for use

administering the contents of the syringe. The needle must be exposed for administration, but all other parts of the syringe should be shielded from view.

Preferably, the method further comprises the step of depressing the second housing portion such that the engagement surface forces the plunger of the syringe to depress, expelling the contents of the syringe from the needle. This provides the advantage of substantially masking the syringe from view while allowing the assembled masking package to be used in the same manner as an unmasked syringe. it should be appreciated that according to a further aspect of the presentinvention, the adaptor element and the first housing portion may be integrally formed, with the first housing portion, which comprises the features of the adaptor element in two portions such that it may be assembled around a syringe.

According to a fifth aspect of the present invention, there is provided a kit of parts for a masking package for blind testing of materials stored in a container, comprising: an opaque housing; a first adaptor element for fixing a container of a first size to the housing; and a second adaptor element for fixing a container of a second size to the housing; wherein, the housing is formed of a first housing portion and a second housing portion, and an adaptor element is configured to be fixed, in use, to a container and an inner surface of the first housing portion, and wherein the second housing portion can, in use, move relative to the first housing portion.

Preferably, this kit of parts further comprises at least one further adaptor for fixing a further container of a further size to the housing. This advantageously allows containers of different sizes and shapes to be concealed securely within the package and used in blind drug trials

According to a sixth aspect of the present invention, there is provided a kit of parts for a masking package for a syringe, comprising: an opaque housing; a first adaptor element for fixing a syringe of a first size to the housing; and a second adaptor element for fixing a syringe of a second size to the housing; wherein, the housing is formed of a first housing portion a second housing portion, each of the first and second adaptor elements are configured to be fixed, in use, to a corresponding one of a syringe of a first size and a syringe of a second size, and an inner surface of the first housing portion, the second housing portion includes an inner surface for engaging with the plunger of the syringe, and wherein, the second housing portion can, in use, move relative to the first housing portion to engage and actuate the plunger of a syringe fixed to the adaptor element and the first housing portion. Preferably, this kit of parts further comprises at least one further adaptor for fixing a further syringe of a further size to the housing. This advantageously allows syringes of different sizes and shapes to be concealed securely within the package and used in blind drug trials.

Preferably, this kit of parts further comprises at least one further second housing portion including an inner surface for engaging with the plunger of the syringe of a further size. This further allows syringes of different lengths with different shaped plungers to be concealed securely by the package for use in blind drug trials.

In the context of this disclosure, the term 'syringe' is used to define a medical syringe for administering liquids. The term 'vial' is used to describe a glass or plastic vessel or bottle of the type used to store liquid medication. The term 'cross piece' is used to define the element that extends outwards from the barrel of the syringe for a user to hook their fingers over in use to secure the syringe. The term 'in use' defines the time between the masking package being assembled and the point at which the contents of the container are being

administered to the patient or participant. The term 'blind drug trial' refers to any form of medical or clinical trial for a drug or medication wherein the patient or participant taking part in the trial, and often the healthcare professional administering the substance, does not know what substance is being administered to them.

Any feature in one aspect of the invention may be applied to other aspects of the invention, in any appropriate combination. In particular, method aspects may be applied to apparatus aspects, and vice versa. Furthermore, any, some and/or all features in one aspect can be applied to any, some and/or all features in any other aspect, in any appropriate combination.

It should also be appreciated that particular combinations of the various features described and defined in any aspects of the invention can be implemented and/or supplied and/or used independently.

Brief description of the drawings

One or more embodiments of the present invention will now be described by way of non- limiting example only and with reference to the accompanying drawings, in which:

Figure t is a cross-sectional view through a first embodiment of the assembled package to be used to mask a syringe;

Figure 2 is a perspective cross-sectional view of the adaptor of Figure 1 ;

Figure 3a is cross-sectional view of the first holding portion of the masking package of Figure 1. and Figure 3b shows the detail of the retaining projection within it; Figure 4a is a cross-sectional view of the second housing portion, and Figure 4b shows a perspective view its outside;

Figure 5a is a perspective view of the assembled masking package and Figure 5b is a front view of the assembled masking package;

Figure 8a is a detailed cross-sectional view of the assembled package, and Figure 6b shows it in a depressed position after use;

Figure 7 is a perspective cross-sectional view of a second embodiment of an adaptor to be used with a syringe embodying the invention;

Figure 8 is a cross-sectional view of a second embodiment of a second housing portion embodying the invention;

Figure 9a is a detailed cross-sectional view of a second embodiment of the assembled package, and Figure 9b shows it in a depressed position after use, while Figure 9c shows an exploded view of this assembled package with an additional washer, and Figure 9d shows a detailed view of the washer;

Figure 10 is a cross-sectional view of an assembled package to be used to mask a vial;

Figure 1 1 is a cross-sectional view of the assembled package of Figure 10 including a vial;

Figure 12 is a perspective view of the assembled package of Figure 10;

Figure 13 is a perspective view of the package of Figure 10 in use; and

Figure 14 is a cross-sectional view of the assembled package to be used with a vial of a different size to that shown in Figure 10.

Detailed description of preferred embodiments

Figure 1 shows an assembled syringe masking package. A syringe 101 is shown held within an adaptor 122. The adaptor 122 is secured around the cross piece 103 of the syringe 101. This adaptor 122 is retained within a first lower housing portion 104 such that the syringe 101 is fixed securely within and relative to the housing. The adaptor 122 is arranged such that the barrel 05 of the syringe 101 is concealed within the opaque walls of the first housing portion 104, with the needle 109 emerging from an orifice 123 such that it may be used to inject a patient or participant. The adaptor 122 is also arranged such that the plunger 107 of the syringe 101 , before use, emerges from an open end 124 of the first housing portion 104 to allow the plunger 107 to be depressed in use to expel the contents of the syringe 101 out through the needle 109. A second housing portion 102 is slidable along the length of the first housing portion 104. It has an inner circumference larger than the outer circumference of the first housing portion 104 which allows it to receive the first housing portion 104 within it and slide along the length of the first housing portion 104. The second housing portion 102 is first located at an end of the first housing portion 104, over the open end 124. in this position it conceals the plunger 107 of the syringe 101. As it slides over the length of the first housing portion 104 it allows the plunger 107 of the syringe 101 to be depressed while it is shielded from view.

The adaptor, or holding or securing element 122 is a two part element. Figure 2 shows the one half of the adaptor or holding element 122 used to secure the syringe 101 and fix it within the first housing portion 104. The adaptor or fixing element 122 is provided in two identical halves. This allows it to be assembled around a syringe 101. Each adaptor 122 is generally cylindhcal in shape, and made of rigid plastics. The adaptor 122 has a wide portion 121 separated from a narrow portion 123 by a narrowing near the middle of the adaptor 122. The adaptor 122 is configured to be assembled around the cross piece 103 of a syringe 101 , locking the cross piece 103 of the syringe 101 into a channel 125 formed when the two halves of the adaptor 122 are brought together.

The connecting mechanism between the two halves of the adaptor 122 is made up of a male projection 130 projecting from a first inner surface 134 of the narrow portion 123 of the adaptor 122, and a hole 132 on a second inner surface 136 of the narrow portion of the adaptor 122. When the two halves of the adaptor 122 are brought together, such that the inner surfaces 134,136 of the narrow portion 123 abut, each male projection 130 is positioned opposite a hole 132 in the other half of the adaptor 122 such that the projections 130 may slide into the holes 132 to hold the two halves of the adaptor 122 securely in place about a syringe.

Each adaptor 122 has a shelf or shoulder 128 extending across the inside of the wide portion 121 of the adaptor 122. This shelf 128 has a circular hole 138 at the centre, wide enough for the barrel of a syringe to pass through. The shelf or shoulder 128 forms the upper or lower wall of the channel 125 that holds the cross piece of the syringe in place. The other wall is formed by the narrowing of the adaptor 122 or an additional ledge (not shown). Thus when the adaptor 122 has been assembled about the syringe, the syringe cannot move within the adaptor 122 but is retained with respect to the channel 125. Furthermore, when the adaptor 122 is fixed within the first housing portion 104, the syringe cannot move within the first housing portion 104, but is retained with respect to the channel 125 of the adaptor 122

The first housing portion 104 that receives the adaptor 122 is shown in Figure 3a. It is a hollow, cylindrical casing made of rigid plastic designed to hide from view the syringe within it. The first housing portion has a first open end 124, and an orifice 123 in a second end which is an opening narrower than the first open end 124. The first housing portion 104 has a window 108 through which the user can view the contents of the syringe to ensure the correct dose is administered, while the identifying features of the syringe are still hidden. The first housing portion also has flanges 110 extending outwards from the first open end of the first housing portion that allow the user to grip the masking package 100 in the same manner as a user wouid grip the cross piece of a syringe. There are support struts 1 12 extending parallel to the first housing portion, from the flanges 1 0 that provide support for the first housing portion in use. The bases of these struts 1 12 form a seat 1 13, This seat 113 acts as a stop for a second housing portion 102 that is inserted between the first housing portion 04 and the struts 1 12 through an opening 120. The second housing portion 102 has an inner radius similar to the widest outer radius of the first housing portion 104, allowing it to slide past the first housing portion 104 until it is stopped by the seat 1 13.

As can be seen in Figure 3a the first housing portion 104 narrows in the middle to create a wide portion 114 and a narrow portion 1 16. This narrowing creates a ledge 118 part way down the first housing portion 104. This ledge 1 18 acts as a stop for the adaptor 122 of the masking package 100 The adaptor 122 can be inserted through the first open end 124 of the first housing portion 104 until it reaches the ledge 1 18. The inner wall of the first housing portion has a retaining projection 126, shown clearly in Figure 3b. This projection 126 is positioned to engage with a groove 119 in the outer wall of the adaptor element 122. The projection 126 is sufficiently small that the adaptor element 122 may pass over it until the point at which the groove 1 19 engages with the projection 126, at which point the projection 126 is retained within the groove 1 19, and the adaptor element 122 is held in position. In the absence of large forces on the adaptor element pushing it further in or out of the first housing portion 04, the projection 126 prevents the adaptor element moving or sliding within the housing.

As shown in Figure 2 each adaptor 122 has a small lip 140 extending outwards from the opening of the wide portion 121 . When the adaptor 122 is inserted into the first housing portion 104 this lip 140 is wider than the inner diameter of the first housing portion 104. It therefore cannot pass within the first housing portion 104, and when the adaptor element 122 is inserted into the first housing portion 104, the lip 140 abuts the top edge of the first housing portion 104 and prevents it moving any further into the housing. At this point during assembly, the projection 26 engages with the groove 1 19, and the adaptor element 122 abuts the ledge 1 18. Together this retains the adaptor element 122 holding the syringe, securely in place within the first housing portion 104. It is essential to provide this means of retaining the adaptor 122 in position to allow effective use of the syringe within the masking package 100. Movement of the syringe can result in harm being done to the patient or participant during administration of the drug.

Once the adaptor 122 is securely in place within the first housing portion 104, holding the syringe in position, the second housing portion 102 is positioned with its outer wall 142 in the opening 120 between the wall of the first housing portion 104 and the struts 1 12. As can be seen in Figure 4a the second housing portion 102 is a hollow cylindrical element of roughly the same width along its entire length, closed at one end by a wall 146 and open at the opposite end. Within the second housing portion 102 is a protrusion 144. The protrusion 144 is a solid rod that protrudes from the wall 146 into the second housing portion 102 along its central axis. This protrusion 144 is configured to have a surface 148 which engages with the top of the plunger of a syringe As can be seen in Figure 4b the second housing portion also has a hole in the end wall 146 which releases the air held within the second housing portion 102 when the second housing portion 102 is slid over the first housing portion 104 to depress the plunger of a syringe.

Figures 5a and 5b show the fully assembled masking package 100. The adaptor 22 is concealed within the first housing portion 104, locking the syringe in place within the assembly 100 and out of sight. The second housing portion 102 conceals the plunger of the syringe. The barrel of the syringe is obscured within the first housing portion 104 except for the small section visible through the window 108. In the arrangements shown there is also a needle cover 106 fixed over the needle of the syringe, attached to the second end of the first housing portion 104 adjacent to the orifice 123. The needle cover 106 is a safety feature that prevents injury from the point of the needle before the syringe is used. It is removed to reveal the point of the needle before use.

This arrangement of the masking package 100 can be seen more clearly in Figure 6a. The second housing portion 102 is located within the opening 120 in order to slide along the outer walls of the first housing portion 104 when in use. In this position the surface 148 at the distal end of the protrusion 144 is in contact with the flat, top side of the plunger of the syringe within the first housing portion. The cross piece of the syringe is seen held in the channel 125 of the adaptor 122, in this case between the shelf 128 and the narrowing of the adaptor 122. The barrel of the syringe is held in place in the narrow portion 1 16 of the first housing portion 104, with the needle extending outwards from the orifice 123, but covered by the needle cover 106.

In order to administer the drug contained within the syringe, first the needle cover 106 must be removed, then the second housing portion 102 is pushed so that it passes over the outer wall of the first housing portion 104 and the protrusion 144 pushes the plunger of the syringe into the barrel of the syringe, expelling the contents through the needle While the volume within the two housing portions decreases as the second housing portion 102 is pushed towards the first housing portion 104, the air from within the two housing portions escapes through the hole 145 in the second housing portion 102. Figure 6b shows the masking package with the second housing portion 102 fully depressed. At this point the second housing portion 102 is in a position that blocks the window 108, and thus must be pulled back again for the user to view the contents of the syringe. After use the masking package

100 is disposed of, and the syringe is at no point seen by the user or the patient.

The assembly of the syringe masking package starts with securing the adaptor element 122 around a syringe 101. The two halves of the adaptor element 122 are brought together with the syringe 101 between such that the cross piece 103 of the syringe 101 aligns with the channel 125, and the male projections 130 of each half align with the holes 132 of the opposing half. These two halves of the adaptor element 122 are secured together with opposing forces in order to retain the syringe 101 between the halves The adaptor element 122, with the syringe 101 within it is then inserted into the first housing portion 104. It is slid in through the open end 124 of the first housing portion 104, led by the needle 109 of the syringe 101. The adaptor element 122 slides through the first housing portion until the small lip 140 meets the projection 126 on the inner wall of the first housing portion. A small amount of force is required to pass the lip 140 over the projection 126, and the adaptor element 122 then sits on the ledge 118 of the first housing portion 104 with the needle 109 of the syringe

101 emerging from the orifice 123. The needle cover 106 can then be placed over the orifice 123 to protect the needle 109 and protect the user from the needle 109.

The assembly of the syringe masking package 100 is finished by positioning the second housing portion 102 with the open end adjacent to the open end 124 of the first housing portion 104. The wider cylinder of the second housing portion 102 can slide over the narrower first housing portion 104. In position before use the second housing portion 102 is positioned with the opening adjacent to the open end of the first housing portion 104 to conceal the plunger 107 of the syringe 101 , with the surface 148 of the protrusion 144 engaged with the plunger 107. In use the second housing portion 102 is slid along the length of the first housing portion 104 and the plunger 107 of the syringe 101 is forced into the barrel 105 of the syringe 101,

The first housing portion 104 is designed to be used with syringes of many different sizes and shapes so as to be used in blind drug trials with a wide range of syringes that may be used. The simple retaining mechanism of the projection 126 may be used with many different adaptors 122 so long as the outer radius and height of the adaptor remains the same. Similarly the simple administration technique allows for different second housing portions 102 to be used for different syringes given that the outer wall 142 remains the same.

Figure 7 shows an adaptor 122' for use with a syringe with a longer and wider body, containing more liquid, than the syringe of the previous adaptor 122. This longer and wider syringe requires the shelf 128^' within the adaptor 122' to be positioned higher in the adaptor, and the hole 138' at the centre has a larger radius. The connecting mechanism of the two halves of the adaptor 22' is the same as for the previous adaptor 122. Figure 8 shows a second housing portion 102' to be used with this longer and wider syringe. The protrusion 144' is much shorter such that it is in contact with the flat top side of the longer plunger of the syringe within the first housing portion 104'. These elements function in the same way with respect to the first housing portion 104, which does not change depending on the syringe. Figures 9a and 9b show the assembled masking package 100^' before and after use to demonstrate the interaction of the elements. Although the adaptor 122' and the second housing portion 104' vary, the external appearance of the masking package 100,100' remains the same.

Figure 9c shows an exploded view of an alternative embodiment of this arrangement. This alternative embodiment also includes a washer 150. This washer may be used in the adaptor for use with a long and wide syringe or a short and narrow syringe as in the earlier figures. The washer 150 is positioned in the opening 120, between the flanges and the first housing portion 103. When the second housing portion 102 is inserted into the opening 120, the washer 50 lies against the outer wall 142 of the second housing portion 102 to fill the gap between the two housing portions 102, 104 and assist with smooth movement of one along the other when the masking package is in use. The washer 150 has protruding flat sides 156 that lie on top of the flanges 1 10. The shape of these sides 156 are the same as the flanges 1 10 such that they align with the flanges 1 10. The washer 150 has two stabilising portions 158 that extend from the flat sides 156 at substantially a right angle. These stabilising portions 158 lie against the outer wall 142 of the second housing portion 102 when the masking package is assembled. Figure 9d shows the connection of the washer 150 and the first housing portion 104 in more detail. When a washer 150 is included in the masking assembly, the first housing portion 104 includes a receiving hole 152 on the inner edge of the flange 1 10. This receiving hole 152 is positioned to receive a ridge 154 on the outer surface of the washer 150. This ridge 154 slides into the receiving hole 152 when the washer 150 is inserted to prevent it rotating when in use.

Another alternative embodiment is shown in Figure 10, the masking package 300 is used to mask a drug vial 301. In this second aspect, shown without the vial, the first housing portion 304 is cylindrical, with a first closed end 306 and an open end 308. The first end 306 includes an orifice 323 through which the needle of a syringe (not shown) can be inserted,

The second housing portion 302 of this embodiment serves as a cap top cover the orifice 323 in the first housing portion 304. The second housing portion 302 is cylindrical with a first closed end 310 and a second open end 312. The inner diameter of the open end 312 of the second housing portion 302 is wider than the outer diameter of the closed end 306 of the first housing portion 304, such that it can fit over the top of the closed end 306. The second housing portion 302 is substantially shorter than the first housing portion 304. The first housing portion narrows towards the first closed end 306 such that the second housing portion 302 can be inserted over the end of the first housing portion 304, providing a continuous outer surface to the assembled package 300.

The first housing portion 304 additionally narrows in the middle to create a wide portion 314 and a narrow portion 316. This narrowing creates a ledge 318 part way down the first housing portion 304. This ledge 318 acts as a stop for the adaptor 322 of the masking package 300.

The adaptor 322 of this embodiment is cylindrical with a first closed end 324 and a second open end 325. The adaptor 322 has an outer diameter narrower than the inner diameter of the open end 308 of the first housing portion 304 such that the adaptor 322 may fit inside the open end 308 of the first housing portion 304. The adaptor 322 includes a projection 344 extending from the inner surface of the closed end 324.

An inner wall 320 of the first housing portion 304 has a groove 319 extending about the inner circumference of the wide portion 314. The adaptor element 322 further includes a retaining projection 326 projecting from an outer wall of the adaptor element, This projection 326 is positioned to engage with the groove 319 in the inner wall 320 of the first housing portion 304. The projection 326 is sufficiently small that the adaptor element 322 may pass through the wide portion 314 of the first housing portion 304 until the point at which the groove 319 engages with the projection 326, at which point the projection 326 is retained within the groove 319, and the adaptor element 322 is held in position. At this point the open end 325 of the adaptor element 322 abuts the ledge 318 of the first housing portion 304. In the absence of large forces on the adaptor element pushing it further in or out of the first housing portion 304, the projection 326 prevents the adaptor element moving or sliding within the housing.

When a vial 301 is inserted into this embodiment of the masking package 300, it is inserted through the open end 308 of the first housing portion 304, top 303 first. Top in this case is used to mean the end of the vial that includes the lid through which the contents are accessed, regardless of orientation of the vial or masking package. The vial 301 is inserted until the top 303 abuts the inner surface of the closed end 306 of the first housing portion 304.

The adaptor 322 is then inserted into the open end 308 of the first housing portion 304. The adaptor 322 is designed to seal the open end 308 of the first housing portion 304, creating a flat surface at the open end 308 when fully inserted, while the projection 344 abuts the bottom 305 of the vial within the first housing portion 304. Bottom in this case is used to mean the end of the vial opposing the top, regardless of orientation of the vial or masking package

In this assembled arrangement, shown in Figure 1 1 and 12, the vial 301 within the masking package 300 is fully concealed from view. If the second housing portion 302 is removed, as shown in Figure 13, the orifice 323 in the first housing portion 304 is accessible. It is through this orifice 323 that a needle can be inserted into the vial 301 through the top in order to retrieve the drug within. This can be done without the user viewing the vial itself.

Figure 14 shows an additional embodiment of the vial masking package 300' wherein a shorter vial 301 ' is masked. The same first 304 and second housing portions 302 are used such that the external appearance of the package is the same, independent of the length of the vial. This embodiment includes an adaptor 322' with a longer protrusion 344' to abut the bottom 305' of the shorter vial 301 '.

Claims

C aims

1. A masking package for blind testing of materials stored in a container, comprising: an opaque housing; and

an adaptor element for fixing a container to the housing,

wherein the housing is formed of a first housing portion and a second housing portion, the adaptor element is configured to be fixed, in use, to a container and an inner surface of the first housing portion, and wherein the second housing portion can, in use, move relative to the first housing portion.

2. A masking package according to claim 1 , for use in blind testing of medicinal materials,

3. A masking package according to any of claims 1 or 2, for use in blind testing of liquid medicinal materials.

4. A masking package according to any preceding claim, wherein the first housing portion comprises an opening at a first end and a substantially closed second end with an orifice for receiving a syringe needle, and wherein the second housing portion comprises an opening at a first end and a dosed second end.

5. A masking package according to any preceding claim, wherein the adaptor element has an external major dimension, smaller than the corresponding internal major dimension, in a direction transverse to the longitudinal axis of the first housing, of the first housing portion at the end adjacent to the first open end of the first housing portion, such that the adaptor element is insertable into the first housing portion through said first end of the first housing portion.

6. A masking package according to any preceding claim, wherein the first housing portion is substantially cylindrical and wherein the second housing portion is substantially cylindrical,

7. A masking package according to any preceding claim, wherein the adaptor element and the first housing portion are configured to retain the adaptor element and the first housing portion substantially in axial alignment.

8. A masking package according to any preceding claim, wherein the first housing portion includes a first section configured to receive the adaptor element, and a second section configured to receive at least part of the container, the first housing portion further including a shoulder between the two sections,

9. A masking package according to claim 8, wherein the adaptor element is configured to abut the shoulder between the two sections when the adaptor element is fixed in the first housing portion.

10. A masking package according to any preceding claim, wherein the substantially closed end of the first housing portion fits within the open end of the second housing portion.

1 1. A masking package according to any preceding claim, wherein the adaptor element, when inserted into the first housing portion, forms a closure of the first open end of the first housing portion.

12. A masking package according to any preceding claim, wherein an inner surface of the adaptor element includes a projection which, in use, engages with the bottom surface of a container, in order to retain the vial within the masking package.

13. A masking package according to any preceding claim, wherein the adaptor element has a projection on an outer surface to retain the adaptor element within the first housing portion.

14. A masking package according to claim 13, wherein the first housing portion has a recess configured to cooperate with the projection on the outer surface of the adaptor element to retain the adaptor element within the first housing portion.

15. A masking package according to any preceding claim, wherein the container is a vial,

16. A masking package according to any of claims 8 or 9, wherein the second section is configured to receive the barrel of a syringe held within the adaptor element.

17. A masking package according to any of claims 1 to 9 or 16, wherein the open end of one of the two housing portions fits within the open end of the other of the two housing portions, such that one of the first and second housing portion is slidabie within, and relative to, the other of the first and second housing portion.

18. A masking package according to any of claims 1 to 9 or 16 to 17, wherein the second housing portion includes an inner surface for engaging with the plunger of a syringe, and wherein the second housing portion can, in use, move relative to the first housing portion to engage and actuate the plunger of a syringe fixed to the adaptor element and first housing portion.

19. A masking package according to any of claims 1 to 9 or 16 to 18, wherein an inner surface of the second housing portion includes a projection which, in use, engages with the top surface of a plunger of a syringe held in the package, in order to engage with the plunger of a syringe.

20. An adaptor element according to any of claims 1 to 9 or 16 to 19, including, in a direction substantially transverse to the longitudinal axis of the adaptor element, a projecting shoulder configured to abut the side of a cross piece of a syringe facing away from the plunger, when the syringe is fixed to the adaptor element.

21. A masking package according to any of claims 1 to 9 or 16 to 20, wherein the adaptor element comprises two complementary and inter-engageable portions, which assemble around a syringe, and define a channel for receiving the cross piece of a syringe.

22. A masking package according to claim 21 , wherein each portion of the adaptor element includes, in a direction substantially transverse to the longitudinal axis the adaptor element, a channel defined by one or more projecting shoulders, such that when the two portions of the adaptor element are assembled, the one or more projecting shoulders of each portion of the adaptor element abut to form a channel, to receive and retain the cross piece of a syringe.

23. A masking package according to any of claims 1 to 9 or 16 to 22, wherein the first housing portion has a projection on an inner surface to retain the adaptor element within the first housing portion.

24. A masking package according to claim 23, wherein the adaptor element has a recess configured to cooperate with the projection to retain the adaptor element within the first housing portion.

25. A masking package according to any of claims 1 to 9 or 16 to 24, wherein the first housing portion includes a window in a wall of the first housing portion for, in use, viewing an end of a syringe held within the housing, adjacent to the needle end of said syringe.

26. A masking package according to any of claims 1 to 9 or 16 to 25, wherein the first housing portion includes one or more flanges, projecting from an outer surface of the first housing portion, to enable the package to be gripped like a syringe.

27. A masking package according to any of claims 1 to 9 or 16 to 28, wherein the container is a syringe.

28. A kit of parts for a masking package for blind testing of materials stored in a container, comprising:

an opaque housing;

a first adaptor element for fixing a container of a first size to the housing; and a second adaptor element for fixing a container of a second size to the housing; wherein, the housing is formed of a first housing portion and a second housing portion, and an adaptor element is configured to be fixed, in use, to a container and an inner surface of the first housing portion, and wherein the second housing portion can, in use, move relative to the first housing portion.

29. A kit of parts according to claim 28, further comprising at least one further adaptor for fixing a further container of a further size to the housing.

3Q. A kit of parts according to any of claims 28 or 29, wherein the container is a vial.

31. A kit of parts according to claim 28, wherein the container is a syringe, wherein each of the first and second adaptor elements are configured to be fixed, in use, to a

corresponding one of a syringe of a first size and a syringe of a second size, and an inner surface of the first housing portion,

the second housing portion includes an inner surface for engaging with the plunger of the syringe, and

wherein, the second housing portion can, in use, move relative to the first housing portion to engage and actuate the plunger of a syringe fixed to the adaptor element and the first housing portion.

32. A kit of parts according to any of claims 28 or 31 , further comprising at least one further adaptor for fixing a further syringe of a further size to the housing.

33. A kit of parts according to any of claims 28, 31 or 32, further comprising at least one further second housing portion including an inner surface for engaging with the plunger of the syringe of a further size.

A kit of parts substantially as described herein with reference to the figures.

35. A masking package as described herein with reference to the figures.