GB2561617A

GB2561617A - Sealed packages containing medical device components

Info

Publication number: GB2561617A
Application number: GB1706825.5A
Authority: GB
Inventors: Mide Christian; Gido Schon Jimmy; R Rosendal Ken
Original assignee: Conceptomed AS
Current assignee: Conceptomed AS
Priority date: 2017-04-19
Filing date: 2017-04-28
Publication date: 2018-10-24
Also published as: GB201706217D0; GB201706825D0; WO2018193061A1

Abstract

A sealed package 2 comprises a plurality of cavities containing medical device components relating to an arterial blood gas ABG sample collection procedure. The plurality of cavities define a closed base and an open top of package 2. The plurality of cavities comprises: a first cavity 4 containing a syringe 16 or blood collection tube; a second cavity 6 containing a needle hub 18 comprising a needle and removable sheath; and a third cavity 10 containing a vented tip cap 22. Package 2 further comprises a removable backing that both covers and seals the open top of the package 2. First cavity 4 may comprise: a fulcrum defined as a contact point between the syringe or blood collection tube and a wall of the cavity 4, the fulcrum being positioned so that a predefined centre of mass of the syringe/blood-collection-tube is forward of fulcrum, so that the syringe/blood-collection-tube tends to pivot forward into a stable position; and a pocket formed in first cavity 4 that extends forward of, and below the fulcrum to receive a front end of the syringe or blood collection tube when free to pivot into the stable position.

Description

(56) Documents Cited:

WO 2016/177856 A1 US 5554127 A US 20160193444 A1

US 6026959 A US 5483973 A US 20110127188 A1 (71) Applicant(s):

Conceptomed AS

Hattvikveien 2, Postboks 10, Ballstad 8373, Norway (58) Field of Search:

INT CLA61B, A61M, B65D Other: EPODOC, WPI (72) Inventor(s):

Christian Mide Jimmy Gido Schon Ken R Rosendal (74) Agent and/or Address for Service:

Dehns

St. Bride's House, 10 Salisbury Square, LONDON, EC4Y 8JD, United Kingdom (54) Title of the Invention: Sealed packages containing medical device components Abstract Title: Sealed packages containing medical device components.

(57) A sealed package 2 comprises a plurality of cavities containing medical device components relating to an arterial blood gas ABG sample collection procedure. The plurality of cavities define a closed base and an open top of package 2. The plurality of cavities comprises: a first cavity 4 containing a syringe 16 or blood collection tube; a second cavity 6 containing a needle hub 18 comprising a needle and removable sheath; and a third cavity 10 containing a vented tip cap 22. Package 2 further comprises a removable backing that both covers and seals the open top of the package 2. First cavity 4 may comprise: a fulcrum defined as a contact point between the syringe or blood collection tube and a wall of the cavity 4, the fulcrum being positioned so that a predefined centre of mass of the syringe/blood-collection-tube is forward of fulcrum, so that the syringe/blood-collection-tube tends to pivot forward into a stable position; and a pocket formed in first cavity 4 that extends forward of, and below the fulcrum to receive a front end of the syringe or blood collection tube when free to pivot into the stable position.

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- 1 SEALED PACKAGES CONTAINING MEDICAL DEVICE COMPONENTS

The present invention relates to sealed packages containing medical device components, in particular but not exclusively to sterile packages containing fluid transfer or collection devices, and related components, for use in medical procedures.

During various medical procedures, medical practitioners are often required to manipulate a medical device whilst at the same time operating directly on a patient, thus requiring use of both of their hands. For example, during arterial blood gas (ABG) testing, a medical practitioner has to carry out various steps which require use of both of their hands. An arterial blood gas (ABG) test measures the acidity (pH) and the levels of oxygen and carbon dioxide in the blood from an artery. Typically, ABG samples are taken from an artery on a patient’s wrist. During the procedure, a medical practitioner must first position a patient’s arm and then palpate the radial artery on the wrist. The practitioner must clean the intended insertion site with an antiseptic wipe/swab before attaching a needle to a syringe, often whilst continuing to palpate the radial artery. Due to the need for a practitioner to continue to palpate the radial artery, attachment of the needle to the syringe is often completely using a single hand which is both difficult and dangerous as it increases the risk of needlestick injury. Alternatively they may, less desirably, temporarily stop palpating the radial artery whilst they attach the needle to the syringe. This pause in palpating of the radial artery can result in a substandard blood sample.

Whilst continuing to palpate the radial artery, the practitioner must then insert the needle and take a blood sample. Once the syringe has been filled with the requisite amount of blood the needle must be quickly removed from the patient and the medical practitioner must press firmly over the insertion site with a bandage to prevent bleeding. The contaminated needle should be covered or discarded into a sharps bin while minimising the risk of a needlestick injury.

- 2Blood gas samples often contain air bubbles which can contaminate the sample and therefore a medical practitioner typically removes any air bubbles from a blood gas sample as soon as possible after collection. This is achieved by disconnecting the needle from the syringe, attaching a vented tip cap and then removing the air by depressing the plunger on the syringe. Similarly to the attachment of the needle to the syringe, this procedure also is preferably completed using a single hand as the medical practitioner continues to apply pressure to the insertion site. As will be appreciated, this procedure is relatively difficult to achieve using only a single hand.

The present invention seeks to address or at least mitigate the problems outlined above.

According to a first aspect of the present invention there is provided a sealed package containing a plurality of medical device components, the package comprising:

a plurality of cavities for receiving the medical device components, wherein the plurality of cavities define a closed base of the package and an open top of the package;

a removable backing that covers the open top of the package, thereby sealing the medical device components within the package; and at least one adhesive patch arranged on an underside of the closed base and a removable cover for the at least one adhesive patch.

In prior art procedures, the medical device components required to carry out a medical procedure, for example an ABG test, are packaged individually and therefore prior to carrying out a procedure a practitioner must unseal the various packages and empty the components onto a sterile metal tray. The practitioner may then select the various components as they carry out the procedure.

It will be appreciated that carrying out a medical procedure with a package according to the present invention is made considerably easier and safer. The sealed package may contain some or all of the relevant medical device components required to carry out a procedure. By providing all of the components in a single package this ensures that the practitioner will have all the necessary components at their disposal without having to individually collect and open different packages.

- 3This reduces the risk of contamination of the individual components and also guarantees that all the components are present as required for a particular procedure.

Additionally, prior to carrying out a specific medical procedure, a practitioner may remove the removable cover from the at least one adhesive patch and adhere the package to a work surface, e.g. a worktop proximal to a patient. Adhering the package to a fixed surface is advantageous as it holds the package in a fixed position for the practitioner during the procedure. This is particularly advantageous in situations where a practitioner only has a single free hand. By adhering the package to a work surface, it is no longer necessary for a practitioner to physically grip the package when removing components from it. The present invention therefore facilitates single handed removal of components from the package. Furthermore, as will be described below, when the package is adhered to a surface it can provide a resistance to movement which may enable a practitioner to connect some of the medical device components together using only a single hand.

In order to improve the adhesion of the one or more adhesive patches to a surface, it is desirable that the overall contact area between the at least one adhesive patch and a supporting surface is as large as possible. Typically the surfaces on which the package may be placed are flat and therefore in a set of embodiments the closed base of the sealed package comprises at least one substantially flat portion on which the at least one adhesive patch is arranged. Such a flat portion can also assist in stably supporting the package.

A strong adhesion between the package and a surface is desirable and as will be appreciated this will be improved by increasing the size of the adhesive patch. Due to the shape of the package it may only be possible to increase the area of the adhesive patch by providing multiple patches. Therefore in a set of embodiments the at least one adhesive patch comprises a plurality of independent adhesive patches. It will be appreciated that the closed base of the package may comprise multiple base portions, each of which is defined by the plurality of cavities. In such a set of embodiments an adhesive patch may be provided on more than one of the base portions.

- 4The adhesive patch may take various forms. In one set of embodiments the at least one adhesive patch comprises an adhesive strip. The one or more adhesive patches may have any suitable geometrical shape, e.g. square, rectangular, circular, etc.

The at least one adhesive patch may be provided by any suitable means. For example, an adhesive substance may be applied (e.g. sprayed on) to the underside of the closed base of the package and then the removable cover may be applied. Alternatively, the at least one adhesive patch may be provided by a double-sided adhesive pad. For example, one side of the double-sided adhesive pad may be adhered to the closed base of the package and the other side may comprise the removable cover which may be left in place until it is desired to expose the adhesive surface of the pad.

Embodiments of the present invention may be particularly advantageous when used with medical procedures including the use of a fluid transfer or fluid collection device. Therefore in a set of embodiments the plurality of medical device components includes a fluid transfer or collection device comprising a fluid transfer tip. For example, the fluid transfer or collection device useable for an ABG test may be a syringe or blood collection tube. In a preferred set of embodiments the syringe or blood collection tube has an internal volume of 1 ml, 2 ml or 3 ml. In a further set of potentially overlapping embodiments the fluid transfer or collection device comprises a vented or air permeable plunger. In a further set of potentially overlapping embodiments the fluid transfer or collection device comprises a heparinised syringe. A fluid transfer or collection device useable for an ABG test may comprise an inner surface coated with heparin. Alternatively, the fluid transfer or collection device may simply contain heparin, for example in the form of a filter paper soaked in heparin, or a soluble pellet containing heparin, or heparin in any dried form. Of course an anticoagulant other than heparin may be used instead. In a further set of potentially overlapping embodiments the fluid transfer or collection device may comprise a collection chamber containing a mixing ball. In addition, or alternatively, the plurality of medical device components includes one or more of: a needle hub, a closed tip cap, a vented tip cap. Such components may be attachable to the fluid transfer tip of a fluid transfer or collection device.

- 5The fluid transfer tip may form a Luer lock or a Luer slip connection. Preferably the fluid transfer tip is tapered to form a friction fit when connected to a corresponding hub, further preferably comprising a male connector tip that is tapered to form the friction fitting when inserted into a corresponding female hub, e.g. a needle hub or IV port. The fluid transfer tip may be tapered to provide a standard Luer Slip connection. The fluid transfer tip may optionally include a threaded collar to provide a standard Luer Lock connection. Although standard Luer Slip or Luer Lock connections use a male tapered tip that fits inside a female hub, it is envisaged that this could be reversed and the fluid transfer tip could be a female part having an internal taper to form friction fit with a corresponding male hub. Alternatively, or in addition, the fluid transfer tip may comprise means for gripping a hub in a locked position. This may include a snap-fit connection, latch means, gripping fingers, etc. that positively engage i.e. grip a hub when it is connected to the tip. This may be particularly suitable for high pressure fluid connections e.g. when transferring or collecting more viscous fluids.

In a preferred set of embodiments the plurality of medical device components includes: a fluid transfer or collection device comprising a fluid transfer tip; and at least one other component attachable to the fluid transfer tip. The component that is attachable to the fluid transfer tip may be any suitable component for use in a given medical procedure. In a set of embodiments, the attachable component is a needle hub comprising a needle and a removable needle sheath. In addition, or alternatively, the attachable component is a vented tip cap. In at least some embodiments, the package may provide a kit for an ABG sample collection. The package may therefore comprise a plurality of cavities containing medical device components relating to an arterial blood gas sample collection procedure.

According to a second aspect of the invention there is provided a sealed package comprising:

a plurality of cavities containing medical device components relating to an arterial blood gas sample collection procedure, the plurality of cavities defining a closed base of the package and an open top of the package;

the plurality of cavities comprising a first cavity containing a syringe or blood collection tube, a second cavity containing an attachable component in the form of

- 6a needle hub comprising a needle and removable sheath, and a third cavity containing an attachable component in the form of a vented tip cap; and a removable backing that covers the open top of the package, thereby sealing the medical device components within the package.

Such a package provides the advantage of a readymade kit sealed in a single package with each component separated from the others in its own designated cavity. The plurality of cavities may be integrally formed in an open blister with the backing attached to close the blister and form a containing wall of the package.

The removable backing covers multiple cavities and can be lifted off in a single operation, conveniently presenting multiple device components at the same time. A common sterilisation operation may be applied to the components contained in the same package. Preferably the plurality of cavities is formed from a single piece of material, for example a blister moulded from a plastics material. In various embodiments the sealed package may further comprise at least one adhesive patch arranged on an underside of the closed base and a removable cover for the at least one adhesive patch. The package may have any of the other features already described above.

In a set of embodiments, the plurality of medical device components includes a piercable block of material and the package comprises a corresponding further cavity containing the piercable block of material. A fourth of the plurality of cavities may contain such a piercable block of material. In a preferred set of embodiments, the piercable block of material comprises a plastic foam, such as a foam sponge or polystyrene block. It will be appreciated that once the needle hub has been used, a user may push the needle into the piercable block of material and disconnect the needle hub, which is then held in the block until it can be safely discarded. This avoids the need for a user to access a sharps bin while completing a procedure such as ABG sample collection.

Conventional kits for ABG sample collection procedures may contain a piercable block but the block is loose and rather than contained in a designated cavity in a package. In a [rior art technique for removal of a used needle, the used needle may be pushed into a rubber block of material which is loose on a surface before separating the needle from the syringe. In such prior art techniques it is necessary

- 7for the block of material to be made from rubber so that there is a sufficiently high coefficient of friction between the block of material and the surface, such that when inserting the used needle the block does not slip along the surface. The advantage of providing a piercable block of material in a dedicated cavity within the package is that the block is supported and can not move freely, as a result the block can be made from a wider range of materials such as plastic foam, as mentioned above. The utility of the piercable block may be enhanced in those embodiments where the package comprises an adhesive patch on its underside so that it can be fixed to a surface during use.

The Applicant has recognised that the force applied to push a used needle into the piercable block of material may cause the package to move or tilt if it is not secured to a supporting surface during use. For example, the package may be placed on top of a mattress and an adhesive path, even if present, may not be useable. In order to mitigate the risk of the package tipping over, in at least some embodiments the further cavity containing the piercable block of material is located centrally within the package.

The Applicant has also recognised that, in some situations, a user may push a used needle into the piercable block of material with such force that the needle pushes all the way through the block and pierces the package. It is hazardous for a used needle to stick out the package. Thus, in at least some embodiments the further cavity containing the piercable block of material comprises a gap between a base of the cavity and a base of the piercable block of material in the cavity. This may be an air gap, for example allowing a user to see that a needle has passed all the way through the block. Alternatively this gap may contain a non-piercable material that prevents the needle from being pushed any further down through the block. In some potentially overlapping embodiments, the further cavity containing the piercable block of material may support the piercable block of material above the closed base of the package. Again, an air gap or gap containing a non-piercable material may be present between the closed base of the package and the further cavity.

The Applicant has also recognised that, in some situations, a user may benefit from assistance in guiding a used needle into the piercable block of material. Thus, in at

- 8least some embodiments the further cavity containing the piercable block of material comprises guide walls which taper downwardly from an open end of the further cavity towards the piercable block of material contained within the further cavity. Such guide walls may also ensure that any liquid which drips off the end of the used needle is collected in the further cavity rather than being allowed to drip into contact with any of the other components contained in the package.

Once a used needle has been pushed into the piercable block of material it can remain there until a procedure is complete. The whole package may then be disposed of. However, at least for recycling purposes it is beneficial for the used needle to be disposed of into a sharps bin while the package can be disposed of separately. Thus, in at least some embodiments the piercable block of material is removably supported in the further cavity. For example, the piercable block of material may be removably supported such that it may fall out of the further cavity under gravity. This means that a user can simply turn the package upside down and allow the block containing the needle to fall into a sharps bin. In addition, or alternatively, in at least some examples the further cavity comprises a deformable base that can be deformed to help release the piercable block of material contained therein. A user may push the deformable base inwards to help release the piercable block of material and deposit the block containing the used needle into a sharps bin.

In embodiments wherein the package comprises a fluid transfer or collection device and a needle hub, the needle hub may already be attached to the fluid transfer or collection device in the package. However, as will be appreciated, attaching the needle hub, which carries the needle, to the fluid transfer or collection device significantly increases the length of the cavity required to hold these components. In order to make the most efficient use of space and materials, the Applicant has recognised that it may be desirable to package the fluid transfer or collection device and any attachable component(s) such as a needle hub in a detached configuration. Accordingly, once the package has been opened a practitioner must then attach a component such as a needle hub to the fluid transfer or collection device before it can be used. The one or more adhesive patches, where provided, can assist with the connection process.

- 9In some embodiments, at least one of the plurality of cavities is arranged such that the attachable component can be inserted into and/or removed from the cavity in the same a direction in which it is connected to the fluid transfer or collection device. This can assist with the component being attached to the fluid transfer device in situ.

As discussed above, single-handed assembly of the components contained within the package is preferred. Therefore, in a set of embodiments, the package comprises a cavity arranged to hold one or more attachable components such that the attachable component is presented at the open top. This may be achieved by the shape, depth and/or angle of the cavity. In a preferred set of embodiments, the package comprises an angled cavity arranged to hold at least one attachable component (such as a needle hub) in a tilted position. By presenting the attachable component at the open top, especially in a tilted position, a practitioner may easily attach the component to a fluid transfer or collection device. Furthermore, where there is adhesion of the package to a supporting surface, a practitioner may push and/or twist the fluid transfer tip of the fluid transfer or collection device into connection with the attachable component using only a single hand with the package providing a resistive force.

In embodiments of a sealed package comprising a plurality of cavities containing medical device components relating to an arterial blood gas sample collection procedure, the second cavity may comprise an angled surface arranged to support the needle hub in a tilted position. In addition, or alternatively, the third cavity may comprise a level surface arranged to support the vented tip cap in a level position.

In embodiments of a sealed package comprising a plurality of cavities containing medical device components relating to an arterial blood gas sample collection procedure, the second cavity may be arranged to support the needle hub in a tilted position in a first mode and arranged to grip the sheath of the needle hub in an upstanding position in a second mode. More generally, the second cavity may comprise a gripping arrangement for gripping the sheath of the needle hub.

Gripping arrangements are described further below.

- 10Typically the attachable component(s) such as a needle hub comprise a sheath which must be removed before the assembled device can be used. Of course this sheath may be removed by a practitioner gripping the fluid transfer or collection device, with the attached needle hub, in one hand and removing the sheath with the other hand, however this is less desired as it requires two-handed operation. Therefore in a set of embodiments the package comprises a gripping arrangement for gripping the sheath of the needle hub. The gripping arrangement is preferably provided by a cavity that contains the needle hub. In a preferred set of embodiments, the cavity containing the needle hub may be arranged to hold the needle hub in a tilted position in a first mode and arranged to grip the sheath of the needle hub in an upstanding position in a second mode. The upstanding position may be angled but is preferably vertical. This provides a particularly convenient workflow wherein the needle hub is presented in the tilted position for connection of a fluid transfer or collection device and can then be gripped in the upstanding position while a user pulls the device away to unsheath the needle. It is advantageous for the needle to be unsheathed with a vertical movement so that the risk of needlestick injury is reduced.

A gripping arrangement as mentioned above may be provided by a separate insert in the cavity, or a wall of the cavity may be formed or shaped to provide the gripping arrangement. In a set of embodiments a wall of the cavity includes a recess to provide the gripping arrangement. Such a construction can make it easier for the cavity to be formed as a single piece e.g. of moulded plastics material.

In embodiments of a sealed package comprising a plurality of cavities containing medical device components relating to an arterial blood gas sample collection procedure, the third cavity may comprise a gripping arrangement for gripping the vented tip cap. In addition, or alternatively, the first cavity may comprise a gripping arrangement for gripping a removable part of the syringe or blood collection tube to enable separation of the removable part from the syringe or blood collection tube. The removable part may comprise a lever member removably mounted to the syringe or blood collection tube. In some examples, such a gripping arrangement may be provided by any of the plurality of cavities. In other words, the removable part may be gripped and removed by a cavity other than the first cavity that originally contained the syringe or blood collection tube.

- 11 Although it is desirable for one or more of the medical device components to be connected and/or disconnected in a single-handed operation, manual assistance may be desirable in at least some embodiments. For example, removing a sheath from a needle hub may be difficult using a gripping arrangement of the package alone. The Applicant has recognised that it may be desirable for a user to be able to apply a gripping force to one of the cavities so as to grip the sheath, or other removable component, while using the package as a barrier to ensure sterility is maintained for the medical device components therein. In some embodiments, the package comprises an internal structure arranged in relation to the cavity such that a gripping force applied on opposite sides of the package causes the gripping arrangement to grip the sheath, or other removable component. In other embodiments, this can be facilitated by one ofthe cavities comprising a grippable apex that receives the removable cover or part during use. In embodiments of a sealed package comprising a plurality of cavities for medical device components relating to an arterial blood gas sample collection procedure, the second cavity may comprise a grippable apex that receives the sheath of the needle hub. Such a grippable apex can be readily pinched between finger and thumb to help hold the sheath (or other cover or removable part), from the outside of the package, while it is removed from a medical device component, for example pulling a needle out from its sheath.

According to a further aspect of the invention there is provided a sealed package containing a plurality of medical device components, the package comprising:

a plurality of cavities each containing a medical device component, wherein at least one of the plurality of medical device components comprises a removable part or cover; and a removable backing that seals the medical device components within the cavities;

wherein at least one of the cavities comprises a grippable apex that receives the removable part or cover during use.

The grippable apex is preferably located at a periphery of the package. This makes it easier for a user to access the apex and pinch the gripping arrangement so as to hold the part or cover while it is being removed.

- 12In many, if not all, embodiments of the present invention, the sealed package preferably comprises a sterile package. It will be understood that a sterile package is a package intended to maintain the sterility of terminally sterilised medical device components until the point of use. A sterile package may be defined as one that meets the requirements of International Standard ISO 11607 and/or the BS EN 868 series of European standards.

In any of the embodiments described above, it is a benefit that the sterile interior of the cavities may provide a micro critical aseptic field. The unsealed package may be used as a working tray in place of a traditional metal tray. Ideally the package is stable when placed down on a supporting surface. Undesirable movement of the package can be ensured by an adhesive patch on the underside, where provided. Alternatively, or in addition, the plurality of cavities may be shaped to form a package with a relatively low centre of mass so that it is not easily tipped over during use. In a preferred set of embodiments, the package has a depth (e.g. between the closed base and open top) that is less than a width and/or length by a factor of at least 3, 4, 5 or more. This effectively provides a relatively shallow package which improves stability.

Preferably one or more of the cavities extend to the closed base of the package such that, when placed on a surface, these cavities have a base in contact with the surface. When connecting a fluid transfer or collection device to another attachable component, for example a needle hub or a vented tip cap held within a cavity of the package, the attachable component may simply sit in the cavity and the fluid transfer tip may be pushed and/or rotated into engagement. As will be appreciated, a significant amount of force may be required to achieve connection. By extending the cavity such that it is in contact with a supporting surface, the force being applied is less likely to cause the cavity/package to deform and means that it is less likely to cause the package to move relative to the surface e.g. translational motion or pivotal motion. Preferably each of the plurality of cavities each has the same depth so as to define a closed base for the package that can rest level on a supporting surface.

- 13There will now be described some more general features that may be applied to any of the embodiments described above.

At least one of the cavities may be arranged to enable a medical device component to be tilted up in the package e.g. for ease of access after the package has been unsealed. Preferably one of the plurality of cavities comprises a fulcrum within the cavity, defined as a point of contact between a medical device component arranged in the cavity and a wall of or in the cavity, the fulcrum being positioned such that a predefined centre of mass of the medical device component is forward of the fulcrum so that the medical device component tends to pivot forward about the fulcrum into a stable position; and a front pocked formed in the cavity which extends forward of and below the fulcrum to receive a front end of the component when the component is free to pivot into a stable position. In embodiments of a sealed package comprising a plurality of cavities containing medical device components relating to an arterial blood gas sample collection procedure, the first cavity may comprise a fulcrum as described. Such arrangements are described in more detail in WO 2016/177856, the contents of which are hereby incorporated by reference.

As discussed previously, one of the advantages of the present invention is that the package helps to facilitate single-handed operation of the medical device components contained therein. In the embodiments described above wherein the components comprise, for example, a needle hub carrying a needle, it is preferable that the needle hub can easily be removed from the fluid transfer tip of a fluid transfer or collection device after use. In particular, during an ABG sample collection procedure, it is helpful to be able to disconnect a needle hub singlehandedly before attaching a vented tip cap. Therefore, in a set of embodiments, the fluid transfer or collection device comprises a fluid transfer tip that is tapered to form a friction fitting when inserted into a corresponding female hub and a lever member pivotally mounted to move relative to the fluid transfer tip. The lever member may be provided to assist in disconnecting the fluid transfer tip from another attachable component, for example in any of the fluid transfer devices or connections described and claimed in the Applicant’s prior publications WO 2013/164358, WO 2014/020090 and WO 2015/014914, the contents of which are hereby incorporated by reference.

- 14The removable backing preferably comprises a film that that covers the open top of the package to form an upper surface of the sealed package. The film may be attached in such way that it can be peeled off easily by a user, preferably with one hand. As is discussed above, it is advantageous for a user to be able to open the package with one hand e.g. after it has been adhered to a surface. This can be assisted by the backing comprising a pull tab.

In some embodiments the backing may be arranged such that it can only be partially removed, e.g. peeled back far enough for the components inside the cavities to be exposed. In other embodiments the backing may be arranged such that it is wholly removable from the package. Once the backing has been removed, the sterile interior of the cavity may even be used as a micro critical aseptic field.

Suitable materials for the backing may include (but are not limited to) one or more of: paper, cardboard, nonwoven webs, woven or fabric sheets, plastic films, metal foils, and laminates thereof. For example, the backing may comprise a nonwoven sheet material such as Tyvek® available from DuPont. These nonwoven materials are made from a spunbonded olefin such as HDPE to create tough, durable sheets that are stronger than paper. A nonwoven sheet material such as Tyvek® typically has a higher strength-to-weight ratio than paper, absorbs little or no moisture, and is strong and rip-resistant. The removable backing may be tested for its suitability to keep the package sealed using one or more of the standard tests for Packaging System Integrity, such as: Package Integrity (ASTM F2096: Bubble Emission Test); Seal Integrity (ASTM F1886: Visual Inspection Test, ASTM 1929: Dye Penetration Test); and/or Seal Strength (ASTM F88: Peel Strength Test, ASTM F1140: Burst/Creep Test).

It has already been mentioned above that, in preferred embodiments, the plurality of cavities is integrally formed from a single piece of material, for example a blister moulded from a plastics material. Whether the cavity is formed from a plastics material or not, it is preferable for the cavity to be substantially transparent, so that a user can readily view the device components contained in the package before it is unsealed. The backing may also comprise a substantially transparent material for this reason.

- 15In preferred embodiments where the plurality of cavities is formed from a plastics material, preferably a thermoplastic material suitable for blow moulding or injection moulding, the plastics material may be chosen from: PET (polyethylene terephthalate); PVC (polyvinyl chloride); PCTFE (polychlorotrifluoroethylene); PP (polypropylene); PE (polyethylene); PC (polycarbonate) or copolymers of any of these.

In various examples above, a sheath has been described as a removable part of a needle hub, which is separate to the package, however in some examples it is envisaged that the sheath may instead be an integral part of the package. For example, the package may comprise an integral cavity which forms a sheath for a needle. When the components are inserted into the package, prior to sealing with a backing, a needle may be inserted without a sheath. The advantage of this is that it may be more efficient, in terms of the total amount of materials required or cost of manufacture, to provide an integrated sheath in the package rather than a separate sheath for the needle.

Sealed packages according to embodiments of the present invention may contain many different types of medical device components. According to the U.S. Food and Drug Administration (FDA), a medical device can be defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (FFDCA) as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: (1) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them; or (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. The CDRH classification database contains a list of all products considered by the FDA to be medical devices.

Some preferred embodiments of the present invention will now be described, by way of example only, and with reference to the accompanying drawings, in which:

- 16Fig. 1 shows an embodiment of a package containing a blood gas sample collection kit;

Fig. 2 shows the package seen in Fig. 1 with the backing removed;

Fig. 3 shows a view of the underside of the package seen in Fig. 1;

Fig. 4 illustrates how a syringe may be attached to a needle hub contained in the package seen in Fig. 1;

Fig. 5 illustrates a further step of the attachment of a needle hub seen in Fig. 4;

Fig. 6 illustrates the use of a gripping arrangement for removing a needle sheath; Fig. 7 illustrates the point at which the needle hub and the sheath are separated; Fig. 8 illustrates how a used needle attached to a syringe can be inserted into a cavity of the package seen in Fig. 1

Fig. 9 illustrates how the point at which the used needle seen in Fig. 8 is disconnected from the syringe;

Fig. 10 illustrates how the syringe may be attached to a vented tip cap;

Fig. 11 illustrates how, once attached, the vented tip cap can be removed from the package.

Fig. 12 shows an alternative embodiment of a package containing a blood gas sample collection kit;

Fig. 13 shows the package of Fig. 12 with the wipe and syringe removed;

Fig. 14 shows a side view of the package of Fig. 12 with the syringe in a horizontal orientation before the package has been opened;

Fig. 15 shows a side view of the package of Fig. 12 when the syringe has tilted within the package after the package has been opened;

Fig. 16 shows a side view of the package of Fig. 12 with the wipe and syringe removed and illustrates the position of the needle hub;

Fig. 17 shows the syringe connected to the needle hub in an upright position;

Fig. 18 illustrates how the syringe and needle may be separated from the needle sheath;

Fig. 19 illustrates how the needle hub may be disconnected from the syringe into the piercable block; and

Fig. 20 illustrates how the syringe may be attached to the vented tip cap.

Figure 1 shows an embodiment of a package 2 containing a blood gas sample collection kit. The package comprises a main body which defines various cavities 4, 6, 8, 10 each which contain a discrete medical component for use in an ABG

- 17sample collection procedure. The plurality of cavities 4, 6, 8,10 are all sealed by a single backing 12 which comprises a pull tab 14 to assist when removing the backing 12 from the package 2. The cavity 4 contains (not shown) a syringe 16, the cavity 6 contains a needle hub 18 carrying a sheathed needle, the cavity 8 contains a foam sponge 20 and the cavity 10 contains a vented tip cap 22. Together, the syringe 16, needle hub 18, sponge 20 and vented tip cap 22 provide the equipment to carry out sample collection for an arterial blood gas (ABG) test.

As seen in Figure 2, the backing 12 can be completely removed from the package 2 to reveal its contents. Figure 2 also more clearly shows how the backing 12 is attached to the package 2. The backing 12 can be sealed to the entire outer peripheral top portion 24 of the package 2 thereby completely sealing in its contents. Also shown in this Figure is a central protrusion 26 which has a flat top portion 28. In this embodiment the flattop portion 28 is level with the peripheral top portion 24 and provides a central support for the backing 12 when it is attached to the package 2. In some embodiments the flat top portion 28 simply provides a support and prevents the centre of the backing 12 from being depressed inwards at the centre of the package 2 and perforated. In an alternative set of embodiments the backing 12 may also be adhered to the flat top portion 28 to provide an additional gripping point between the backing 12 and the main body of the package

2.

Figure 2 also shows how the package 2 may also contain other useful components, for example a wrapped isopropyl alcohol wipe 30. In this embodiment the isopropyl alcohol wipe 30 is arranged at the top of the package 2 as it is typically the first piece of equipment which is used during an ABG test sample collection procedure. Figure 2 also more clearly shows how the syringe 16 is contained within the package 2. The cavity 4 has a second portion 4’ which is divided from the cavity 4 by a central wall 32. The central wall 32 provides a fulcrum about which the syringe 16 may pivot. By arranging the central wall 32 in an appropriate position it is possible to ensure that the syringe 16 tips in a specific direction in the cavity 4. When the backing 12 has been removed, and the isopropyl alcohol wipe 30 has been removed, the front end of the syringe 16 may tilt downwards into the second portion 4’ such that its plunger 34 moves upwards and out of the package 2. This presents the plunger 34 in a manner that it easier for the practitioner to grab. This

- 18therefore encourages them to grab this end of the syringe 16 rather than the front end comprising the fluid transfer tip and therefore this helps to avoid potential contamination.

It can be seen that the needle hub 18 is supported at approximately a 45 degree angle in the cavity 6. The advantage of supporting the needle hub 18 at this angle will be described in more detail later. The needle hub 18 comprises a needle 36 and outer protective sheath 38. Next to the needle cavity 6, proximal to a corner of the package 2, is a gripping arrangement 40 which will be described in more detail with respect to later drawings.

Figure 3 shows a view of the underside of the package 2 seen in Figures 1 and 2. Here it can be seen that the cavities 4, 4’, 6, 8, 10 all define a base which, when the underside is placed down on a surface, will be in contact with the surface. Located on a base wall 42 of the cavity 4 is an adhesive strip 44 and/or on a base wall 46 of the cavity 4’ is a second adhesive strip 48. During use, these adhesive strips may be used to secure the package 2 to a work surface. Each of the adhesive strips 44, 48 may have a removable cover (not shown) which prior to use covers the adhesive strips 44, 48 such that they do not undesirably stick to objects. When the kit is being used, a practitioner may remove the removable covers so as to reveal the adhesive strips 44, 48 and then stick the package 2 to a work surface. The removal of the removable covers may be carried out prior to the removal of the backing 12 or alternatively it may be carried out afterwards.

Whilst two adhesive strips 44, 48 are shown in Figure 3, the package 2 may function equally well with a single adhesive strip or alternatively further adhesive patches may be provided, for example on the base of the other cavities 8, 10. It is envisaged that each of the adhesives strips may have an individual removable cover such that each cover has to be removed independently of the others. Alternatively the removable covers may be linked together such that the removable covers may be removed in a single step, for example a shared backing cover.

As discussed previously, whilst the adhesive patches are shown as adhesive strips 44, 48 in this embodiment, they may take any suitable geometrical form. Also, the entire base portion of the package 2 may be provided with an adhesive surface.

- 19Once any removable cover(s) has been removed from the adhesive patches or surface, the package 2 may be secured to a work surface such that it is held in a fixed position.

Figure 4 shows the package 2 in use. Whilst it is not explicitly shown, the package 2 is secured to a work surface using at least one adhesive patch or surface as described above. It can be seen that, at this stage, the syringe 16 has been removed from the package 2. The syringe 16 carries a pivotally mounted disconnecting member in the form of a lever member 50. This type of syringe is described in more detail in WO 2013/164358, WO 2015/014914 and WO 2016/162571, the contents of which are hereby incorporated by reference. The use of this lever member 50 will be described with reference to later Figures. As this particular package 2 contains an ABG test sample collection kit, the first step for the medical practitioner is to attach the needle hub 18 to the fluid transfer tip 52 on the syringe 16. This is achieved by removing the syringe 16 from the package 2 and inserting the fluid transfer tip 52 into the needle hub 18. The 45 degree angle at which the needle hub 18 is held means that the hub 18 is presented outwards of the package 2 and therefore makes attachment of the needle hub 18 easier for the practitioner as they do not have to manipulate the needle hub 18. In particular, the needle hub 18 and fluid transfer tip 52 may have a Luer slip fitting so that the tip 52 can be pushed into the needle hub 18 with one hand, rather than needing to hold the needle hub 18 to rotate a Luer lock fitting. In at least some examples the needle hub 18 may be gripped by its cavity 6 so that one-handed connection to a Luer lock fitting is also possible.

As the needle hub 18 rests at an angle and against the base of the cavity 6, when a force is applied to the needle hub 18 in an axial direction, to attach the needle hub 18 to a Luer slip or Luer lock fitting, there will be both a horizontal and vertical component of force. The vertical component of the force is resisted by the base of the cavity 6, which is supported by the surface on which the package 2 rests and the horizontal component is resisted by a side wall of the cavity 6. Rotational forces are also resisted when connecting to a Luer lock hub. Of course, if the package 2 were not secured to the surface by the adhesive strips 44, 48 then the package 2 would slide along the surface unless it was held by the practitioner. The adhesive strips 44, 48 therefore help to facilitate single-handed assembly by the practitioner.

- 20It may be possible for the syringe 16 to be fully attached to the needle hub 18 in this configuration, alternatively it may be necessary to pivot the syringe 16 and needle hub 18 into a vertical position and push down harder before they can be fully connected together with a tight Luer slip connection.

Figure 5 shows the point during use at which the syringe 16 has been, at least partially, connected to the needle hub 18. The syringe 16 may then be rotated through around 45 degrees in the direction indicated by the arrow whilst the needle hub 18 and sheath 38 remain in the cavity 6. At this stage the sheath 38 will rest in the gripping arrangement 40. If the needle hub 18 and syringe 16 were not fully connected together in the previous stage, a practitioner may apply a sufficient vertical force to the syringe 16 so as to connect the two parts. In this orientation, the vertical force will be in a direction perpendicular to the plane of the work surface and therefore should not cause the package 2 to move relative to the work surface.

The next stage is the removal of the sheath 38 from the needle hub 18. This is shown in Figure 6. Here it can be seen that a practitioner may grip the outer surface of the package 2 near to the gripping arrangement 40 with a pinching movement. Due to the flexibility of the plastic from which the package 2 is manufactured, the walls of the gripping arrangement 40 deform slightly and effectively grip the sheath

38. As discussed above, the advantage of this arrangement for removing the sheath 38 is that there is an extra barrier for protection between the needle hub 18 which carries the needle 36 and the practitioner’s fingers. This helps to avoid needlestick injuries and reduces the risk of contamination of the needle 36. Once the practitioner has gripped the gripping arrangement 40, using their other hand they may then pull the syringe 16 in the direction shown by the arrow.

The result of the pulling on the syringe 16 can be seen in Figure 7. Once the syringe 16 has been pulled upwards the needle 36 and needle hub 18 are separated from the sheath 38 which remains in the gripping arrangement 40 of the package 2. The practitioner may then go on to use the syringe 16 with the attached needle hub 18 to obtain a blood sample.

In an alternative set of embodiments which are not shown, the gripping arrangement 40 may, on its own, apply a sufficiently large gripping force to the

- 21 needle sheath 38 such that it is not necessary for the practitioner to grip the gripping arrangement 40. Of course this particular embodiment is advantageous as it facilitates single-handed assembly of the components. When the syringe 16 is pulled away from the package 2 to separate the needle hub 18 from the sheath 38, the adhesive strips 44, 48 may hold the package 2 to the surface and thereby hold the sheath 38 in a fixed position relative to the surface. In an alternative set of embodiments, wherein the package 2 does not comprise any adhesive strips or patches, the weight of the package 2 and its natural friction against a work surface may be sufficient to hold the sheath 38 in a fixed position when the needle hub 18 is pulled away.

During an ABG test, once the practitioner has obtained a blood sample, it is then preferable to expel any air bubbles from the syringe 16. This is achieved by attaching a vented tip cap 22. Before the vented tip cap 22 can be attached to the syringe 16 it is necessary to disconnect the needle hub 18. Figure 8 illustrates how the needle hub 18 can be disconnected. A practitioner may first insert the needle 36 into the sponge 20 provided in the cavity 8. Once the needle 36 has penetrated the sponge 20 and is held securely in place, the practitioner may then apply a force to the lever member 50 in a direction illustrated by the arrow shown in the Figure. The pivotal movement of the lever member 50 results in a front surface 54 of the lever member 50 acting on the hub 18 so as to disconnect it from the fluid transfer tip 52.

Figure 9 shows the point at which the needle hub 18 has become disconnected from the fluid transfer tip 52. The needle 36 is inserted sufficiently far into the sponge 20 such that the sponge 20 holds the needle 36 and associated needle hub 18 in a vertical position.

Of course the step of disconnecting the needle hub 18 into the sponge 20 is not strictly necessary as often the needle hub 18 does not need to be reused. A practitioner may therefore simply disconnect the needle hub 18 into one of the empty cavities 4, 4’, 6 in the package 2 or, if available, they may disconnect the hub 18 directly into a sharps bin.

Irrespective of where the needle hub 18 has been disposed, once the needle hub 18 has been removed from the fluid transfer tip 52 a practitioner may then attach

-22the vented tip cap 22 to the syringe 16. This process is shown in Figure 10. The fluid transfer tip 52 on the syringe 16 can be inserted directly into the cavity 10 to the point at which the fluid transfer tip 52 engages with the vented tip cap 22. The practitioner may then apply a sufficiently large force in a vertical and/or rotational direction so that the vented tip cap 22 is securely attached to the fluid transfer tip 52. As seen in Figure 11, once the syringe 16 has been attached to the vented tip cap 22, the syringe 16 can be pulled away from the package 2. A practitioner may then expel any air bubbles from the blood sample contained within the syringe 16.

In the examples shown a syringe 16 is provided in the package 2 for carrying out the ABG sample collection procedure. However, it will be appreciated that a syringe is not necessarily required and a different fluid transfer or collection device may be provided in the package instead, for example a blood collection tube.

Figure 12 shows an alternative embodiment of a package 102 containing a blood gas sample collection kit. The package 102 contains a fluid transfer device in the form of a syringe 116, a needle hub 118, a vented tip cap 122, a wrapped isopropyl alcohol wipe 130, and other components (not seen) which will be discussed with reference to later Figures. It can be seen that the syringe 116 comprises a plunger 134 and a fluid transfer tip 152. The syringe 116 is supported in a cavity provided by the package 102 by a first internal wall 154 and second internal wall 156. The first internal wall 154 forms a fulcrum for the syringe 116 which will be described in more detail with reference to Figures 14 and 15. The first and second internal walls 154, 156 also define a cavity 110 in which the vented tip cap 122 is contained. A further internal structure 158 partially defines a cavity 106 which contains the needle hub 118. The needle hub 118 comprises a needle 136 and associated removable sheath 138. The wrapped isopropyl alcohol wipe 130 is positioned on the top of the other components within the package 102 as this is typically the first component required in an ABG test sample collection procedure. Whilst it is not shown in this Figure, similarly to the first embodiment, a sealed package will initially also comprise a removable backing that covers the open top of the package 102 to seal the components 116, 118, 122, 130, etc. within the package 102.

Figure 13 illustrates how the package 102 may further contain a piercable block of material 120 contained within a further cavity 108. The function of the piercable

- 23block of material 108 will be described in more detail later with reference to Figure

19. In this embodiment, the further cavity 108 comprises a rounded, funnel shaped, guide wall 158 which tapers downwardly from an open end of the further cavity 108 towards the piercable block of material 120. Typically the package 102 will be relatively small and so the piercable block of material 120 will also be relatively small, for example the top surface of the block 120 into which a user may insert the needle 136, after use, may be around 10 mm by 10 mm. This is a relatively small target area for the practitioner to direct the syringe 136 into and therefore the guide wall 158 effectively increases the target area and can help to guide the needle 136 into the piercable block of material 120 if it is not contacted directly. The guide wall 158 may also help to catch any drips of blood from a used needle and direct them into the further cavity 108 e.g. so that the vented tip cap 122 does not become contaminated.

Additionally, it can be seen that the piercable block of material 120 contained in the further cavity 108 so as to be located centrally within the package 102. It may be the case that a relatively significant force is required for the needle 136 to penetrate the piercable block of material 120 and so positioning the further cavity 108 containing the piercable block of material 120 centrally within the package 102 means that the package 102 should remain stable when the needle 136 is being inserted. The central location of the further cavity 108 therefore assists in preventing tilting and/or sliding of the package 102 during insertion of the needle 136 into the block 120.

Figure 14 shows the package 102 in an unopened state, but the isopropyl alcohol wipe 130 and removable backing are not shown for clarity purposes. In this unopened state, the main body of the syringe 116 is supported by both the first and second internal walls 154, 156 and the plunger 134 will be in contact with the backing (not shown). At this stage the syringe 116 is held in an unstable horizontal position.

Figure 14 also shows the side profile of the piercable block of material 120 contained in the further cavity 108. Here it can be seen that the piercable block of material 120 is supported within the further cavity 108 such that there is a gap 160 between the base of the piercable block of material 120 and the base of the cavity

- 24108. As discussed previously, if a user inserts a needle into the piercable block of material 120 with a considerably large force there is a risk that the needle will penetrate the entire depth block of material 120 and protrude through the base of the piercable block of material 120. An advantage of the gap 160 is that if a needle 136 does penetrate the block of material 120 and pass into the gap 160, a practitioner may be able to visually see that this has happened and stop applying force to the needle hub 118 via the syringe 116. As the package 102 may, in certain instances, be held by a practitioner, seeing a needle in this gap 160 and ceasing applying further force may help to prevent the practitioner from forcing the needle through the base of the package 120 which may otherwise result in a neeedlestick injury.

The piercable block of material 120 may be held within the further cavity 108 to form the gap 160 via any suitable means. For example, the shape of the cavity 108 may taper such that its dimensions at its base are smaller than that at the opening, by providing a piercable block of material that has dimensions which are larger than that of the internal dimensions of the cavity 108 at its lowest point but equal to the internal dimensions at a mid-point, the piercable block of material 120 may simply be held in an elevated position by the internal walls of the cavity 108. Alternatively, the cavity 108 may comprise a structure which protrudes from its base to support the base of the piercable block of material 120 and hold it away from the base of cavity 108 thereby forming the aforementioned gap 160.

The piercable block of material 120 may only be loosely contained in the cavity 108 such that it can easily be removed if desired. For example, once a practitioner has inserted the needle 136 into the pierceable block of material 120 and disconnected the needle hub 118, attached the vented tip cap 122 to the syringe 116and finished the ABG sample collection procedure, it may be necessary to dispose of the components of the kit. This disposal may require the needle hub 118 to be disposed of in a sharps bin. If the piercable block of material 120 is removably supported by the cavity 108, a practitioner may simply turn the package 102 upside down over a sharps bin and the needle hub 118 with its needle 136 in the piercable block of material 120 may simply fall out of the package 102 and into the sharps bin. This further improves the safety of the practitioner during the procedure as it means they never have to physically come into contact with the needle 136. Alternatively, or in

- 25addition, the further cavity 108 may comprise a deformable base that can be depressed to help 'pop out' the block 120.

Figure 15 shows the package 102 in an opened state when both the backing and the isopropyl alcohol wipe 130 have been removed. Due to the fact that the syringe 116 comprises a lever member 150 which is arranged proximal to the fluid transfer tip 152, the syringe 116 is heavier at the fluid transfer tip 152 end of the syringe 116 compared to the end which houses the plunger 134. The internal wall 154 is positioned within the package 102 such that it acts as a fulcrum about which the syringe 116 can pivot forward. Once the backing has been removed from the top of the package 102, the syringe 116 tends to pivot forward into a stable position such that the fluid transfer tip 152 moves down into a pocket forward of the fulcrum 154 in the package 102 and the plunger 134 end of the syringe 116 tilts up, extending out of the package 102. This can be seen in Figure 15. This pivotal movement where the plunger 134 end of the syringe 116 presents itself out of the package 102 is advantageous as it means a user can more easily grab the syringe 116 from the package 102 by the plunger 134 end, which also discourages them from grabbing the end proximal to the fluid transfer tip 152 which can result in contamination.

Figure 16 illustrates the stage at which the syringe 116 has been removed from the package 102. Similarly to the other embodiment described above, the cavity 106 comprises a surface supporting the needle hub 118 at an angle within the package 102 such that the needle hub 118 presents itself at the main opening of the package 102. A practitioner may therefore easily insert the fluid transfer tip 152 of the syringe 116 into the needle hub 118 in order to connect the two parts together with a Luer slip or Luer lock fitting. It can be seen that the sheath 138 rests against the base of the cavity 106 and is also supported by an outer wall of the package 102. The result of this support is that it holds the sheath 138 fixed in place when a practitioner inserts the fluid transfer tip 152 into the needle hub 118. The internal structure 158 also provides a gripping arrangement for the sheath 138, as is described further below.

Figure 17 illustrates how, once the fluid transfer tip 152 of the syringe 116 has been inserted into the needle hub 118, the needle hub 118 and associated sheath 138 may be rotated through to a vertical orientation as seen in this Figure. At this point a

- 26practitioner may grip opposite sides of the package 102 proximal to the cavity 106 containing the needle hub 118. As the user applies a gripping force to the opposite sides of the package 102, due to the inherent flexible nature of the plastic from which the package 102 may be manufactured, it will cause the package 102 to deform resulting in the internal structure 158 acting to transfer a gripping force to the sheath 138. Once the sheath 138 has been gripped in the cavity 106 by the internal structure 158, a user may pull the syringe 116 vertically upwards away from the package 102, resulting the needle hub 118 moving away from the sheath 138 thereby leaving the sheath 138 in the cavity 106 and the needle 136 exposed ready for use. This stage at which the needle 136 is unsheathed can be seen in Figure

18.

Figure 19 shows the stage of the procedure at which a practitioner has used the syringe 116 to obtain an arterial blood gas sample and has disconnected the needle hub 18 from the fluid transfer tip 152 of the syringe 116. Disconnection of the needle hub 118 from the fluid transfer tip 152 may be achieved by first inserting the needle 136 into the piercable block of material 120. Once the needle 136 is securely supported by the piercable block of material 120 the medical practitioner may operate the lever member 150 which acts to disconnect the needle hub 118 from the fluid transfer tip 152. The syringe 116 may then be moved away leaving the needle hub 118 and associated needle 136 resting in the piercable block of material. The lever member 150 may be pivotally mounted to the syringe 116, and operated, as is described in more detail in WO 2013/164358, WO 2015/014914 and WO 2016/162571, the contents of which are hereby incorporated by reference.

Once the needle hub 118 has been disconnected, the practitioner may then proceed to attach the vented tip cap 122 to the fluid transfer tip 152. This is achieved by pushing the fluid transfer tip 152 into the vented tip cap 122 until they are fully engaged. Once the vented tip cap 122 has been attached to the fluid transfer tip 152 it may be removed from the package 102 by pulling the syringe 102 vertically upwards. This can be seen in Figure 20. After the vented tip cap has been used to expel air from the blood sample, at a later stage (before or after extracting the blood sample for an ABG test), the vented tip cap 122 may be removed from the syringe 116. This can optionally be achieved using the lever member 150 to disconnect the vented tip cap 122 from the fluid transfer tip 152. Furthermore, it

- 27may be desirable to remove the lever member 150 from the syringe 116, for example if the syringe 116 containing the blood sample is to be inserted into a blood gas analysis machine that does not have space to accommodate the lever member 150. The package 102 may include a cavity that is shaped to grip the lever member 150 when it is inserted therein, allowing a user to separate the syringe 116 from the lever member 150 in another one-handed operation.

Whilst it is not shown in Figures 12-20, as with the first embodiment, the package 102 may comprise an adhesive patch arranged on an underside of its base to enable the package to be securely fixed to a surface during use.

It will be appreciated that, throughout the sample collection procedures described herein, the practitioner may only need one hand to connect and disconnect the various medical device components contained in the package 2, 102. This means that the other hand is free to apply continuous pressure to the arterial puncture site.

The risk of needlestick injuries can also be greatly reduced.

In any of the embodiments described herein, the syringe may comprise one or more features making it particularly suitable for a ABG test sample collection, these features including e.g. heparin in liquid or dried form inside the syringe (i.e. a heparinised syringe), a mixing ball in the syringe, a vented plunger, and a syringe volume of between 1 ml and 3 ml. Although a syringe has been shown in the illustrated embodiments, a suitable blood collection tube may be used instead.

Claims

1. A sealed package comprising:

the plurality of cavities comprising a first cavity containing a syringe or blood collection tube, a second cavity containing a needle hub comprising a needle and removable sheath, and a third cavity containing a vented tip cap; and a removable backing that covers the open top of the package, thereby sealing the medical device components within the package.

2. A sealed package according to claim 1, wherein the plurality of medical device components includes a piercable block of material and the package comprises a further cavity containing the piercable block of material.

3. A sealed package according to claim 2, wherein the further cavity containing the piercable block of material is located centrally within the package.

4. A sealed package according to claim 2 or 3, wherein the further cavity containing the piercable block of material comprises a gap between a base of the cavity and a base of the piercable block of material in the cavity.

5. A sealed package according to any of claims 2-4, wherein the further cavity containing the piercable block of material supports the piercable block of material above the closed base of the package.

6. A sealed package according to any of claims 2-5, wherein the further cavity containing the piercable block of material comprises guide walls which taper downwardly from an open end of the further cavity towards the piercable block of material contained within the further cavity.

7. A sealed package according to any of claims 2-6, wherein the piercable block of material is removably supported in the further cavity.

- 298. A sealed package according to claim 7, wherein the piercable block of material is removably supported such that it may fall out of the further cavity under gravity.

9. A sealed package according to any of claims 2-8, wherein the further cavity comprises a deformable base that can be deformed to help release the piercable block of material contained therein.

10. A sealed package according to any preceding claim, wherein the second cavity comprises an angled surface arranged to support the needle hub in a tilted position.

11. A sealed package according to any preceding claim, wherein the third cavity comprises a level surface arranged to support the vented tip cap in a level position.

12. A sealed package according to any preceding claim, wherein the second cavity is arranged to support the needle hub in a tilted position in a first mode and arranged to grip the sheath of the needle hub in an upstanding position in a second mode.

13. A sealed package according to any preceding claim, wherein the second cavity comprises a gripping arrangement for gripping the sheath of the needle hub.

14. A sealed package according to claim 13, wherein the package comprises an internal structure arranged in relation to the second cavity such that a gripping force applied on opposite sides of the package causes the gripping arrangement to grip the sheath of the needle hub.

15. A sealed package according to any preceding claim, wherein the second cavity comprises a grippable apex that receives the sheath of the needle hub.

16. A sealed package according to claim 15, wherein the grippable apex is located at a periphery of the package.

- 3017. A sealed package according to any preceding claim, wherein the third cavity comprises a gripping arrangement for gripping the vented tip cap.

18. A sealed package according to any preceding claim, wherein the first cavity comprises a gripping arrangement for gripping a removable part of the syringe or blood collection tube to enable separation of the removable part from the syringe or blood collection tube.

19. A sealed package according to claim 18, wherein the removable part comprises a lever member removably mounted to the syringe or blood collection tube.

20. A sealed package according to any preceding claim, wherein the first cavity comprises a fulcrum within the cavity, defined as a point of contact between the syringe or blood collection tube contained in the cavity and a wall of the cavity, the fulcrum being positioned such that a predefined centre of mass of the syringe or blood collection tube is forward of the fulcrum so that the syringe or blood collection tube tends to pivot forward about the fulcrum into a stable position; and a front pocket formed in the first cavity which extends forward of and below the fulcrum to receive a front end of the syringe or blood collection tube when the syringe or blood collection tube is free to pivot into a stable position.

21. A sealed package according to any preceding claim, wherein the syringe or blood collection tube comprises a fluid transfer tip that is tapered to form a friction fitting when inserted into a corresponding female hub, and a lever member pivotally mounted to move relative to the fluid transfer tip.

22. A sealed package according to any preceding claim, wherein the removable backing comprises a film that that covers the open top of the package to form an upper surface of the sealed package.

23. A sealed package according to any preceding claim, wherein the removable backing is wholly removable from the package.

- 31

24. A sealed package according to any preceding claim, comprising at least one adhesive patch arranged on an underside of the closed base and a removable cover for the at least one adhesive patch.

5

25. A sealed package according to claim 24, wherein the closed base of the sealed package comprises a substantially flat portion on which the at least one adhesive patch is arranged.

26. A sealed package according to any preceding claim, where the plurality of

10 cavities is formed from a plastics material.

27. A sealed package according to any preceding claim, comprising a sterile package.

15

28. A sealed package according to any preceding claim, wherein the package has a length of between 70 mm - 100 mm, a width of between 30 mm and 50 mm, and a depth of between 15 mm and 30 mm.

Intellectual

Property

Office

Application No: GB1706825.5 Examiner: Colin Powys