AU2016287775A1

AU2016287775A1 - Pharmaceutical vessel holder

Info

Publication number: AU2016287775A1
Application number: AU2016287775A
Authority: AU
Inventors: Annette Margaret NUNN; Christopher Leslie NUNN
Original assignee: Ampisafe Pty Ltd
Current assignee: Ampisafe Pty Ltd
Priority date: 2015-06-29
Filing date: 2016-06-24
Publication date: 2018-01-25
Also published as: WO2017000024A1

Abstract

The present invention provides a pharmaceutical vessel holder comprising a handle region and a vessel receiving region. The vessel receiving region is distal to the handle region such that, in use, the pharmaceutical vessel is maintained a minimum distance from the hand or a user on the handle region. The vessel receiving region may comprises an aperture or basket configured to receive (and optionally support) an upper region of a vessel disposed therein. In some embodiments, the holder is substantially transparent.

Description

The present invention provides a pharmaceutical vessel holder comprising a handle region and a vessel receiving region. The vessel receiving region is distal to the handle region such that, in use, the pharmaceutical vessel is maintained a minimum distance from the hand or a user on the handle region. The vessel receiving region may comprises an aperture or basket configured to receive (and optionally support) an upper region of a vessel disposed therein. In some embodiments, the holder is substantially trans parent.

WO 2017/000024

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PHARMACEUTICAL VESSEL HOLDER

FIELD OF THE INVENTION

The present invention relates generally to a tool useful in medical and veterinary practice. In 5 particular, the invention relates to a holder for presenting a pharmaceutical vessel to a medical or a veterinary practitioner in the course of a patient treatment.

BACKGROUND TO THE INVENTION

In medical and veterinary practice, it is often necessary to inject a pharmaceutical substance 10 into or about an open wound of the patient. For example, in the course of a surgical procedure a local anaesthetic such as lidocaine may be injected into an exposed tissue of the patient using a standard syringe. In other cases, a pharmaceutical substance may be injected into substantially intact skin, or into a tissue damaged in some manner such as by way of trauma or a burn.

In these contexts, the injectable pharmaceutical substance is typically drawn from a singleuse or multi-use vessel such a vial or an ampoule. The pharmaceutical substance may be initially presented in a lyophilised form to which water is added to form a solution or suspension. Alternatively, the substance may already be in the form of a suspension or a solution.

In any event, the vessel is typically manually handed to the practitioner charged with administering the injectable substance to the patient. For example, an assisting nurse may hand a vial to a doctor in the course of a medical procedure. The doctor draws up a required volume of the solution from the vial into a syringe, with the same syringe being subsequently used to inject the solution into the patient.

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In such procedures, it is sometimes the case that a wound of the patient becomes infected with a bacterium, fungus or other microbial agent.

A further problem is that an incorrect pharmaceutical substance may be administered because 5 of a failure of the doctor to adequately verify the contents of the vial.

Yet another problem is that the doctor may need to view the contents of the vial to ensure, for example, the absence of any solids therein. Alternatively, the doctor may need to view the contents to check the level of solution in the vial to ensure a sufficient amount of solution is present before drawing up into a syringe.

It is an aspect of the present invention to overcome or alleviate a problem of the prior art by providing improved means for handling a vial containing a pharmaceutical substance. It is a further aspect to provide a useful alternative to prior art means for handling a vial.

The discussion of documents, acts, materials, devices, articles and the like is included in this specification solely for the purpose of providing a context for the present invention. It is not suggested or represented that any or all of these matters formed part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.

SUMMARY OF THE INVENTION

In a first aspect, but not necessarily the broadest aspect, the present invention provides a pharmaceutical vessel holder comprising a handle region and a vessel receiving region.

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In one embodiment, the pharmaceutical vessel holder is configured such that the vessel receiving region is distal to the handle region such that, in use, the pharmaceutical vessel is maintained a minimum distance from the hand or a user on the handle region. In one embodiment, the minimum distance is about 5, 6,7,8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18,

19, 20, 21,22, 23, 24, 25, 26, 27, 28, 29 or 30 cm.

In one embodiment, the handle region is shaped and dimensioned so as to allow the hand or an adult female person to substantially completely encircle it.

In one embodiment, the upper surface of the handle region is substantially planar so as to allow a thumb of a user to be disposed on the upward-facing surface of the handle region with at least the index finger of the same hand of the user disposed on the downward-facing surface.

In one embodiment, the handle region is narrow relative to the vessel receiving region.

In one embodiment, the vessel receiving region comprises an aperture or basket configured to receive (and optionally support) an upper region of a vessel disposed therein.

In one embodiment, the pharmaceutical vessel holder comprises a vessel base supporting region.

In one embodiment, the vessel base supporting region is disposed directly below the aperture.

In one embodiment, the pharmaceutical vessel holder comprises an intermediate region connecting the vessel receiving region to the vessel base supporting region.

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In one embodiment, the intermediate region has a height of at least about 2, 3, 4, 5, 6, 7, 8, 9, or 10 cm.

In one embodiment, the pharmaceutical vessel holder is configured to hold a standard pharmaceutical vial or a standard pharmaceutical ampoule.

In one embodiment, at least a portion of the vessel supporting region or the entire pharmaceutical vessel holder is transparent or partially transparent.

In one embodiment, the pharmaceutical vessel holder is marked so as to allow a user to identify a pharmaceutical vessel, or a range of pharmaceutical vessels for which the holder is useful.

In one embodiment, the vessel receiving region is configured so as to separately receive two or more pharmaceutical vessels.

In a second aspect of the invention there is provided a set of two or more pharmaceutical vessel holders as described herein, wherein the holders are configured so as to hold different vessels.

In a third aspect, there is provided by the present invention a combination of a pharmaceutical vessel and the pharmaceutical vessel holder of the first aspect, the pharmaceutical vessel being disposed into, on or about the vessel receiving region.

In a fourth aspect, the present invention provides a method for handling a pharmaceutical vessel, the method comprising the steps of: providing the pharmaceutical vessel holder as described herein, providing a pharmaceutical vessel, and placing the pharmaceutical vessel into, onto or about the pharmaceutical vessel holder.

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BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is a perspective view of a preferred pharmaceutical vessel holder of the present invention. The holder is being held by the hand of a user, and contains a pharmaceutical ampoule.

Fig. 2A is a diagrammatic plan view of the pharmaceutical vessel holder of Fig. 1.

Fig. 2B is a diagrammatic section view of the pharmaceutical vessel holder of Fig. 1, the section taken through the line X-X’ as shown in Fig. 2A.

Fig. 3 shows in perspective view various modifications of the pharmaceutical vessel holder of Fig. 1

Figs. 4A, 4B and 4C show in diagrammatic forms several standard pharmaceutical vessels, the dimensions of which are detailed in Tables 1 to 6.

DETAILED DESCRIPTION OF THE INVENTION

Reference throughout this specification to one embodiment or an embodiment means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases in one embodiment or in an embodiment in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments.

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Similarly it should be appreciated that the description of exemplary embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment of this invention.

Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and from different embodiments, as would be understood by those in the art.

In the claims below and the description herein, any one of the terms “comprising”, “comprised of” or “which comprises” is an open term that means including at least the elements/features that follow, but not excluding others. Thus, the term comprising, when used in the claims, should not be interpreted as being limitative to the means or elements or steps listed thereafter. For example, the scope of the expression a method comprising step A and step B should not be limited to methods consisting only of methods A and B. Any one of the terms “including” or “which includes” or “that includes” as used herein is also an open term that also means including at least the elements/features that follow the term, but not excluding others.

Thus, “including” is synonymous with and means “comprising”.

The present invention is predicated at least in part of Applicant’s finding that the shedding of microbes from an individual’s hand, arm or other body part onto a wound (or an area of a

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PCT/AU2016/050541 patient’s skin that is about to be incised) leads to an increased potential for infection in the patient. In addressing that problem, the use of a pharmaceutical vessel holder is proposed.

Accordingly, in a first aspect the present invention provides a pharmaceutical vessel holder comprising a handle region and a vessel receiving region. Applicant has discovered that use of such a holder decreases the potential for infection of an open wound or even intact skin during a surgical procedure lessens the need for intrusion of a hand, arm or other body part into the surgical field. For example, it is proposed that in the process of a nurse handing a vial to a doctor (the hand over occurring about the surgical field, as is typical) microbes may shed from the vessel handler’s skin, clothing, or glove and contact the patient. The present invention allows a spatial separation of the pharmaceutical vessel from the handler’s hand, arm or other body part such that intrusion of a body part of the user about the surgical field is minimised, or substantially avoided. Preferably, the holder is configured such that at least a hand of the user is maintainable in an area outside the surgical field during the process of handing the pharmaceutical vessel to the treating practitioner.

As used herein, the term “surgical field” is intended to include the surface of a patient subject to a treatment and for which it is desired to maintain substantial sterility, and also the space immediately above that surface.

Use of the vessel holder of the present invention lessens the intrusion of body parts into the surgical field, on the assumption that the holder is less likely to have a microbe residing thereon. Of course, this advantage provided by the present vessel holder is increased according to the cleanliness of the holder. Accordingly, it is preferred that the vessel holder is fabricated from a material having a substantially smooth and/or non-porous surface so as to avoid attachment of microbes and/or facilitate removal of microbes during a cleansing procedure. Furthermore materials that are amenable to effective sanitization, disinfection or sterilization are preferred. Thus, plastics, metals and vitreous materials are generally

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PCT/AU2016/050541 preferred. In this regard, it is also preferred for the holder to comprise predominantly substantially planar regions so as to avoid the entrapment or build up of infectious material such as microbes.

It will be appreciated, however, the vessel holder may be embodied in sterile disposable form in which case issues surrounding porosity and the ability to efficiently cleanse the holder are essentially obviated. Accordingly cellulose-based materials such as cardboards or light duty plastics may be used to fabricate the present vessel holder. Disposable vessel holders may be sterilized by ionizing radiation, for example, and packaged in a sterile environment to prevent subsequent contamination with a microbe.

The handle region and the vessel receiving region may be separated by an intermediate region. The intermediate region may be configured so as to ensure a minimum distance between the pharmaceutical vessel and the hand of a user. Preferably the intermediate region is shaped and/or sized such that the hand of a user does not intrude into the surgical field in the process of the vessel being presented to a treating practitioner.

Use of the present holder provides the further advantage that, at least in some embodiments, absence of a hand about the vessel facilitates reading of a vessel label, or viewing pharmaceutical substance inside the vessel.

A further advantage provided is in the avoidance of a needle stick injury to a handler of a pharmaceutical vessel. For example, when injecting water into a vessel to dissolve a lyophilised pharmaceutical substance it is not uncommon for the individual to miss the vessel and pierce a finger or hand with the syringe needle. A similar injury may arise when drawing up a pharmaceutical solution from a vessel.

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Yet another advantage is that a spent pharmaceutical vessel may be discarded by tipping the holder to cause the vessel to fall out into a waste receptacle. In this way, the there is no need for the user to contact the vessel thereby reduce the risk of injury or contamination.

It will be understood that not all advantages discussed herein are applicable to all embodiments of the invention.

The handle region may be configured so as to be easily gripped by the hand of a user. The skilled person is familiar with many types of hand grips, such as those used on cutlery, hand tools, handles, and the like and is capable of incorporating same into the present holder. For simplicity of construction (and also to facilitate cleansing) the handle region may be substantially planar and elongate so as to allow a user’s thumb to be disposed on an upwardfacing surface with at least the index finger (and preferably all fingers) of the same hand of the user disposed on a downward-facing surface.

In one embodiment, the vessel receiving region comprises an aperture, optionally of substantially circular geometry. The aperture may be sized so as to allow a rim (or other extension) of the pharmaceutical vessel to be supported by the surface surrounding the aperture. In this way, the upper end of the vessel (being the end from which the pharmaceutical substance is drawn) is maintained above the surface of the vessel receiving region and therefore accessible by the treating practitioner.

To improve stability of the vessel, the aperture is typically shaped according to the shape of the intended vessel. Given that pharmaceutical vessels are generally cylindrical, it is typical for the aperture to be circular. However, it will be appreciated that utility extends to holders having apertures which are non-circular including ovoid, square, triangular, rectangular, pentagonal, hexagonal, heptagonal, octagonal etc., or indeed an irregular shape.

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Alternatively, the vessel receiving region may have sufficient depth such that the aperture is a blind hole into which the vessel is inserted. In this embodiment, the base of the hole supports the vessel so that the upper end of the vessel is maintained above the surface of the vessel receiving region. The wall of the hole is not necessarily continuous, with cut-outs in the wall being contemplated. Similar embodiments may form the hole by the use of a wire basket, or even a simple L-shaped member extending downwardly from the aperture edge such that the vessel base is supported by the horizontal portion of the member.

In one embodiment, the holder comprises a vessel base supporting region. For example, the vessel receiving region may comprise both an aperture into which the vessel is insertable, and also a discrete base supporting region which prevents the vessel from being further inserted into the aperture such that the upper end of the vessel is maintained above the surface of the vessel receiving region. This embodiment is distinct from that where the vessel receiving region comprises a hole given that no material of the vessel holder extends around the vessel when fully inserted. In this way, the contents or the label of the vessel may be directly viewable by the user and/or the treating practitioner.

As an example (and as shown in the preferred embodiment of Fig. 1) the vessel base supporting region may be an extension of the vessel receiving region and integral therewith.

Such embodiments are preferable due to the ease of fabrication whereby a single elongate member may be bent in two locations so as to dispose the vessel support region immediately below the aperture of the vessel receiving region.

As will be appreciated the size and geometry of the various components of the vessel holder may be customized according to the size and geometry of the vessel(s) for which the holder is configured to be operable. For example, the aperture of the vessel receiving region may have a diameter which is marginally larger than the outside diameter of the intended vessel.

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In this way, the vessel is permitted to easily slide through the aperture but is properly supported against excessive lateral movement within the aperture.

Similarly, the depth of any aperture or basket, or the distance between the aperture rim and a vessel supporting region is such that the upper end of the vial extends above the surface of the vessel receiving region.

The vessel receiving region of the pharmaceutical vessel holder may be configured so as to separately hold two or more pharmaceutical vessels such that no vessel contacts any other vessel. The pharmaceutical vessels may be the same (in terms of size, capacity or contents) or may be different. Such embodiments allow for the holder to be used in a specific surgical procedure, for example, requiring a predetermined combination of injectable. The holder may be configured to hold a first relatively small ampoule comprising a local anaesthetic which is used as a first step in a procedure, and a second relatively large ampoule comprising a relatively large plastic ampoule containing a saline solution for flushing the surgical field after an incision.

In one embodiment, the vessel receiving region and/or the vessel base supporting region is/are not adjustable. This negates the need for a user to open or close a clamp or other adjustable mechanism in order to accommodate a given vessel. As will be appreciated, in order to accommodate the different sizes of vessels as likely to be encountered in medical or veterinary practice, a set of vessel holders having differing geometries and dimensions may be provided with each holder being useful for one (or a subset) of pharmaceutical vessels. Where a set is provided, each holder of the set may be marked in some manner so as to allow a user to discern which holder is useful for a given vessel. For example, a numerical marking may be used (e.g. 20 ml.) to indicate the volume of an intended vessel. Given the benefit of the present specification other means of discerning a holder will be apparent to the skilled

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PCT/AU2016/050541 person including printed letters or words, graphical indicia, aperture shapes, and handle shapes for example.

Alternatively, either whole or part of each of the holders may be differentially coloured such that the user comes to associate a certain colour with a holder being useful in handling a certain size of pharmaceutical vessel. In this way, a user may immediately recognise the desired holder, and without any need to carefully inspect any printed marking.

Where provided as a set, the individual pharmaceutical vessel holders may be presented in vendible form within a single package (such as a box or a bag) or may be designated by a single product code by a manufacturer, wholesaler or retailer.

The holders of the present invention may be configured so as to securely retain any of the standard vessel types used in the presentation of pharmaceutical substances. As an example, a holder may be configured to hold (and with minor lateral movement) a closed or open glass ampoule manufactured by SCHOTT™ Pharmaceutical Packaging according to ISO 9187:2010. Reference is made to Table 1 below which shows the measurements of a range of closed glass ampoules. Reference is made to Fig. 4A indicating the physical elements of the ampoules to which the measurements shown in Table 1 apply.

Table 1 Stock Sizes - Closed Glass Ampoules - Form D

Size	a	b	d	e	n
1ml	10.75	21	70	6.0	25.5
2ml	10.75	33	83	6.0	37.5
5ml	14.75	41	95	7.0	46.5
10ml	17.75	55	112	7.1	62.0
20ml	22.50	65	126	7.8	76.0
25ml	27.50	107	141	7.8	116.5

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Reference is made to Table 2 below which shows the measurements of a range of closed glass ampoules. Reference is made to Fig. 4B indicating the physical elements of the ampoules to which the measurements shown in Table 2 apply.

Table 2 Stock Sizes - Open Glass Ampoules - Form B

Size	a	b	d	e	n
1ml	10.75	21	60	8.0	25.5
2ml	10.75	33	72	8.0	37.5
5ml	14.75	41	83	9.0	46.5
10ml	17.75	55	102	9.5	62.0
20ml	22.50	65	113	11	76.0

Reference is made to Tables 3 and 4 below which shows the measurements of a range of tubular glass Injection Vials/Lyophilisation Vials manufactured by SCHOTT™ including DIN standard ISO 8362-1:2009 compliant vials. Reference is made to Fig. 4C indicating the physical elements of the vials to which the measurements shown in Tables 3 and 4 apply.

Table 3 Stock Sizes - Tubular Clear Glass Injection Vials/Freeze Drying Vials

Size	Brimful	a	b	t	c	e	m
2ml	3.8ml	14.3	39.5	0.95	13	7.00	26.0
2ml	4ml	16.0	35.0	1.0	13	7.00	22.0
4ml	6ml	16.0	45.0	1.0	13	7.00	33.0
5ml	9.7ml	22.3	38.0	1.1	20	12.75	24.5
6ml	10ml	22.0	40.0	1.0	20	12.60	27.0
8ml	11.5ml	22.0	45.0	1.0	20	12.60	32.0
10ml	14ml	24.3	46.0	1.1	20	12.75	32.0
10ml	13.5ml	24.0	45.0	1.0	20	12.60	31.0

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15ml	19ml	24.0	60.0	1.0	20	12.60	46.0
20ml	26ml	30.0	55.0	1.2	20	12.60	35.0
20ml	26.5ml	29.3	56.0	1.1	20	12.75	38.0
30ml	37.5ml	30.0	75.0	1.5	20	12.60	55.0
50ml	65ml	42.5	68.0	1.5	20	12.60	42.0
100ml	125ml	47.0	100.0	1.7	20	12.60	75.3

Table 4 Stock Sizes - Tubular Amber Glass Injection Vials/Freeze Drying Vials

Size	Brimful	a	b	t	c	e	m
2ml	4ml	16.0	35.0	1.0	13	7.0	22.0
6ml	10ml	22.0	40.0	1.0	20	12.6	27.0
10ml	13.5ml	24.0	45.0	1.0	20	12.6	31.0
20ml	26ml	30.0	55.0	1.2	20	12.6	35.0
30ml	37.5ml	30.0	75.0	1.5	20	16.6	55.0
50ml	65ml	42.5	68.0	1.5	20	12.6	42.0

Reference is made to Tables 5 and 6 below which shows the measurements of a range of moulded glass Injection Vials/Lyophilisation Vials manufactured by SCHOTT™ including DIN standard ISO 8362-1:2009 compliant vials. Reference is made to Fig. 4C indicating the physical elements of the ampoules to which the measurements shown in Tables 5 and 6 apply.

Table 5 Stock Sizes - Moulded Clear Glass Injection Vials/Freeze Drying Vials

Size	Brimful	a	b	c	e	m
10ml	15ml	25.4	53.5	20	12.6	35.3
20ml	26ml	32.0	58.0	20	12.6	36.1
30ml	38ml	36.0	62.8	20	12.6	41.3
50ml	60ml	42.5	73.0	20	12.6	46.0
100ml	119ml	51.6	94.5	20	12.6	58.0

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200ml 246ml

65.0 114.5 20 12.6 76.0

Table 6 Stock Sizes - Moulded Amber Glass Injection Vials/Freeze Drying Vials

The above ampoules and vials are exemplary in nature. It will be understood that the holders of the present invention may be configured so as to be useful for ampoules and vials having different dimensions and geometries to those described supra.

Furthermore, the vessel receiving region may be configured so as to retain a pre-filled syringe as a further type of pharmaceutical vessel. The holder may be configured such that the syringe may be retained with the needle portion directed generally downwardly, and so as to prevent contact with an operator or other nearby personnel. For example, a vessel support region may have a small aperture allowing the needle to extend therethrough, with there being a shield or guard disposed inferior to the vessel support region which shrouds the needle portion. Thus, the syringe (when used) may be pulled generally upwardly by the plunger, and away from the holder until the needle tip is clear of the holder.

As discussed elsewhere herein, the diameter of an aperture of the vessel receiving region is marginally larger than that of intended vessel. In some embodiments, the aperture is sized

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PCT/AU2016/050541 such that space of about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm or 10 mm exists between the outer surface of the vessel and the aperture edge.

The holder may be configured (and in some embodiments the intermediate region dimensioned) such that no more than about 50% of the height of the vessel extends beyond the vessel receiving region. In this way, the ability for the vessel to be accidently knocked from holder is limited. In some embodiments, no more than about 5%, 10%, 15%, 20%, 25%, 30%, 40%, or 45% of the height of the vessel extends beyond the vessel receiving region.

In one embodiment, the holder is configured such that the label and/or contents of the vessel is visible (and ant print optionally readable) by a user and/or by the treating practitioner. In that regard, at least a portion of the holder may be fabricated from a substantially visually transparent material.

Preferably, the material transmits all colours substantially equally, and does not have a colourtinted appearance. As will be appreciated, a colour-tinted material will not transmit all printed aspects of a coloured label, thereby opening the possibility of misreading. For example, where a holder is tinted red and the label has red printing, the red printed will be essentially invisible to a person.

The use of transparent material provides the further advantage that some contaminants on the holder (such as blood, or a spilled pharmaceutical substance) will be more visible. Care may therefore be taken to remove the contaminant.

Accordingly, it is preferred that a part of the holder (or indeed all of the holder) is fabricated from an untinted acrylic such as a Perspex™ or a glass having high light transmissibility.

The present holder may be embodied in vendible form, and packaged with instructions for use in medical or veterinary practice. The instructions may be integral with the packaging, provided by way of separate instructional papers. Instructions may be provided in video, audio, graphical or written form.

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The present invention further provides methods for use of the holder. The use may relate to holding the vessel, carriage of the vessel between two points, or passing the vessel from one person to another.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

Turning firstly to Fig. 1 there is generally shown a holder 10 of the present invention useful for handling a circular pharmaceutical ampoule. The holder 10 is fabricated from a single sheet of transparent and untinted Perspex™ being folded at two fold lines 12 and 14. The fold lines 12 and 14 result in a demarcation between an upper ampoule receiving region 16, an ampoule base support region 18, and an intermediate region 20 connecting the ampoule receiving region 16 and the ampoule base support region 18.

The ampoule receiving region 16 comprises an aperture 22 having a diameter marginally greater than the external diameter of the ampoule 32.

Extending from the ampoule receiving region 16 is a handle region 24 about which a user is 15 able to wrap his or her hand. The user’s thumb rests on the upper surface of the handle region about the region marked 26, with the fingers curling below to support the underside. Accordingly, the holder 10 is well supported by the fingers, but is also prevented from being accidentally knocked from the users hand by the compressive force of the thumb so as to clamp the handle region 24 between the thumb and fingers.

Toward the terminus of the handle region 24, and on the upper surface thereof, is a marking 30 indicating the volume of ampoule useful with that particular holder.

Turning now to Fig. 2A there is shown a diagrammatic plan view of the holder 10 shown in Fig. 1 with ampoule 32 inserted. Fig. 2B is a sectional view taken through the line X-X’ of Fig. 1. It will be clear that the upper end of the ampoule is disposed above the ampoule

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PCT/AU2016/050541 receiving region 16, and therefore accessible to a syringe needle (not shown) held by the treating practitioner or other personnel.

In terms of fabrication, the starting material for the holder of Figs. 1,2A and 2B is a rectangular sheet of Perspex™. The aperture 22 is laser cut using methods well known to the skilled artisan, as are the regions removed to form the relatively narrow handle region 24. Folds 12 and 14 are produced using a strip heater by methods well known to the skilled artisan.

The resultant holder is easily cleansed by wiping with a cloth soaked in 70% ethanol or other disinfectant. The alcohol evaporates rapidly leaving a clean and substantially dry holder ready for use.

Fig. 3 shows alternative forms of the holder, with the major components indicated and as numbered in Fig. 1.

In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

In the following claims, any of the claimed embodiments can be used in any combination.

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Claims

CLAIMS:

1. A pharmaceutical vessel holder comprising a handle region and a vessel receiving region.
2. The pharmaceutical vessel holder of claim 1 configured such that the vessel receiving region is distal to the handle region such that, in use, the pharmaceutical vessel is maintained a minimum distance from the hand or a user on the handle region.
3. The pharmaceutical vessel holder of claim 2 wherein the minimum distance is at least about 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21,22, 23, 24, 25, 26, 27, 28, 29 or 30 cm.
4. The pharmaceutical vessel holder of any one of claims 1 to 3 wherein the handle region is shaped and dimensioned so as to allow the hand or an adult female person to substantially completely encircle it.
5. The pharmaceutical vessel holder or any one of claims 1 to 4 wherein the upper surface of the handle region is substantially planar so as to allow a thumb of a user to be disposed on the upward-facing surface of the handle region with at least the index finger of the same hand of the user disposed on the downward-facing surface.
6. The pharmaceutical vessel holder of any one of claims 1 to 5 wherein the handle region is narrow relative to the vessel receiving region.
7. The pharmaceutical vessel holder of any one of claims 1 to 6 wherein the vessel receiving region comprises an aperture or basket configured to receive (and optionally support) an upper region of a vessel disposed therein.
8. The pharmaceutical vessel holder of any one of claims 1 to 7 comprising a vessel base supporting region.
9. The pharmaceutical vessel holder of claim 8 as appended to claim 7 wherein the vessel base supporting region is disposed directly below the aperture.

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10. The pharmaceutical vessel holder of any one of claims 1 to 9 comprising an intermediate region connecting the vessel receiving region to the vessel base supporting region.
11. The pharmaceutical vessel holder of claim 10 wherein the intermediate region has a height of at least about 2, 3, 4, 5, 6, 7, 8, 9, or 10 cm.
12. The pharmaceutical vessel holder of any one of claims 1 to 11 configured to hold a standard pharmaceutical vial or a standard pharmaceutical ampoule.
13 The pharmaceutical vessel holder of any one of claims 1 to 12 wherein at least a portion of the vessel supporting region or the entire pharmaceutical vessel holder is transparent or partially transparent.
14. The pharmaceutical vessel holder of any one of claims 1 to 13 marked so as to allow a user to identify a pharmaceutical vessel, or a range of pharmaceutical vessels for which the holder is useful.
15. The pharmaceutical vessel holder of any one of claims 1 to 14 wherein the vessel receiving region is configured so as to separately receive two or more pharmaceutical vessels.
16. A set of two or more pharmaceutical vessel holders of any one of claims 1 to 15, wherein the holders are configured so as to hold different vessels.
17. The combination of a pharmaceutical vessel and the pharmaceutical vessel holder of any one of claims 1 to 15, the pharmaceutical vessel being disposed into, on or about the vessel receiving region.
18. A method for handling a pharmaceutical vessel, the method comprising the steps of: providing the pharmaceutical vessel holder of any one of claims 1 to 15, providing a pharmaceutical vessel, and placing the pharmaceutical vessel into, onto or about the vessel receiving region .

-20WO 2017/000024

PCT/AU2016/050541

FIG. 1

WO 2017/000024

PCT/AU2016/050541

2/4

I

FIG. 2A

FIG. 2B

WO 2017/000024

PCT/AU2016/050541

FIG. 3

WO 2017/000024

PCT/AU2016/050541

Ζ'··\.............f

FIG. 4C

FIG. 4B