Patent Application
20180085515
The present invention relates to sealed packages containing medical devices, in particular but not exclusively to sterile packages containing fluid transfer devices for use in a medical setting.
In healthcare settings, significant numbers of infections are caused by microorganism contamination due to failed aseptic technique. The clinical environment is typically populated with microorganisms that are antibiotic-resistant. Patients are particularly at risk during invasive clinical procedures and via in situ medical devices such as intravenous (IV) lines. Safe aseptic practice requires that packaging can be opened using a no-touch technique and medical devices can be easily removed from packaging without a user touching (and hence contaminating) any so-called key parts. Key parts are the critical parts of clinical equipment that come into direct or indirect contact with any liquid infusion, key sites and active key parts connected to the patient. However many packages for medical devices such as fluid transfer devices, e.g. syringes, must be pulled open carefully by a user and the onus is on the user to take hold of the device at an end away from the key parts. In practice, it is often found that medical devices are removed from packaging with the recommended no-touch technique being compromised e.g. by opening the wrong end of the packaging and accidentally touching a key part.
In addition, medical devices that carry a needle, such as syringes, must be handled with care to avoid needlestick injuries. Since the EU Council Directive 2010/32/EU on the prevention of sharps injuries in the healthcare sector, regulations have been brought into force to promote the use of “safer sharps” such as syringes with safety mechanisms that prevent a user from recapping the needle. However there remains a need for sterile packages that can protect a user from accidental needlestick injury from the moment when the package is first opened.
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 medical device that has a predefined centre of mass, the package comprising: a cavity containing the device; a removable backing that seals the device inside the cavity; a fulcrum within the cavity, defined as a point of contact between the device and a wall of the cavity, the fulcrum being positioned such that the predefined centre of mass of the device is forward of the fulcrum so that the device tends to pivot forward about the fulcrum into a stable position; and a front pocket formed in the cavity which extends forward of and below the fulcrum to receive a front end of the device when the device is free to pivot into a stable position.
It will be appreciated that such a package is quite different from a standard package where a medical device is closely contained in a cavity and a user must actively remove the device from the cavity. In a standard package the cavity is typically formed to have a shape that generally corresponds to the profile of the device, e.g. to minimise material cost and avoid unnecessary movement of the device inside the package. By providing the cavity with a fulcrum, and a pocket forward of and below the fulcrum, the device naturally tends to pivot (due to the position of its centre of mass forward of the fulcrum) and such pivotal movement can be accommodated by the pocket. This means that the device can pivot into a stable position to automatically present itself once the package is unsealed, for example by pivoting forward so that a rear end of the device becomes more accessible. There are several advantages to the device being tilted. Firstly, this can facilitate ease of access to the device with or without gloved hands. Secondly, the front end of the device being pivoted down into the front pocket can restrict the ability of users to touch key parts at the front end. For example, such a package can ensure that users do not readily come into contact with a fluid transfer tip at the front end of the device e.g. a syringe.
It will be further appreciated that the centre of mass can be predefined for any given medical device, for example depending on its dimensions. If the device is prefilled with a fluid then this may be taken into account. The cavity of the package may then be suitably dimensioned and/or shaped to provide a point of contact between the device and a wall of the cavity that defines a fulcrum, with the centre of mass of the device being positioned forward of the fulcrum. In addition, the extent of the front pocket in the cavity may be determined with reference to the size and/or shape of the device contained in the cavity. It will be appreciated that a package according to the invention may have a different cavity for any particular style of device, but of course various devices such as syringes often come in standard sizes—meaning that a package having a particular form of cavity may in practice be suitable for a number of devices e.g. from different manufacturers. Preferably the package is designed so that the fulcrum is positioned behind the centre of mass of one or more different devices, for example a range of standard syringes having volumes of 2 ml, 5 ml, 10 ml, and even 20 ml, so that the same package can be used to contain more than one device. This can also ensure that the centre of mass of any given device is positioned sufficiently forward of the fulcrum that, even if the device were to move longitudinally within the cavity (for example during transit or handling), the device will still tend to pivot forward about the fulcrum into a stable position.
While the device tends to pivot forward about the fulcrum, due to the position of its centre of mass, it may or may not be free to pivot into a stable position when contained in the sealed package. In some embodiments it is envisaged that the sealed package may allow the device to already be pivoted forward about the fulcrum, for example with the removable backing attached to the cavity so as to accommodate the device with its front end received in the front pocket. This means that once the backing is removed the device may be grasped more easily to be lifted out of the cavity, because it is presented at a tilted angle. The centre of mass being forward of the fulcrum ensures that the front end of the device tends to pivot down into the front pocket e.g. so that it is a rear end of the device which is most accessible once the cavity is unsealed. This can be particularly important for devices being unpackaged by an aseptic technique. Presenting the rear end of a device such as a syringe can help to ensure that users avoid touching a critical connection interface (such as a fluid transfer tip or needle) at the front end of the device—protecting such a key part from contamination and potentially protecting users from needlestick injury.
Where the device is already pivoted forward to present a rear end, typically the package will take up a larger volume than a package in which the device is contained in a flatter but unstable position. It may therefore be preferable for the device to be contained in the cavity in an unstable position e.g. where the device rests on the fulcrum but is substantially prevented from pivoting forward about the fulcrum. This may enable the package to be made more compact with lower material cost. Furthermore, it has been recognised that containing the fluid transfer in an unstable position provides an additional advantage in that opening the package may allow the device to pivot forward so that the front end is received in the front pocket. This can act to automatically protect the front end, and preferably present a rear end of the device to the user, upon opening the package.
Removal of the backing could act in various ways to release the device from an unstable position so that it becomes free to pivot forward about the fulcrum. For example, the device could be held in an unstable position by a blocking member connected to the backing. However it is preferable for the removable backing to directly hold the device in an unstable position, so that as soon as the backing is removed the device becomes free to pivot. Thus in preferred embodiments the removable backing is arranged to substantially prevent the device from pivoting forward into a stable position. In other words, the front end of the device cannot move into the front pocket until the backing has been removed. This could be achieved, for example, by a frangible connection between the backing and the device that holds the device in an unstable position resting on the fulcrum. When the backing is removed such a frangible connection may be broken to allow the device to pivot forward so that its front end is received in the front pocket.
However a simple way to hold the device in an unstable position is for the removable backing to abut a rear end of the device so that the front end is prevented from pivoting forward about the fulcrum. For example, the cavity may take the form of an open blister with the backing attached to close the blister and form a containing wall of the package. It is therefore preferable that the device is contained in an unstable position with the removable backing forming a surface of the sealed package that is in contact with a rear end of the device. This may require the backing to be strong enough to resist the tendency of the device to pivot e.g. without tearing open under the force of the turning moment. 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).
A further advantage of such embodiments is that, once the backing is removed, the rear end of the device will tend to pivot beyond the previously sealed surface as the front end pivots forward. The cavity may be arranged so that this results in the rear end of the device being presented outside the cavity for ease of access. Thus in preferred embodiments the cavity is arranged such that, when the backing is removed, the device is free to pivot forward so that the rear end of the device projects out of the cavity beyond the previously sealed surface. This may be achieved by designing the geometry of the cavity relative to the fulcrum, for example the shape of the front pocket. Preferably the front pocket extends below the fulcrum to such a depth that a rear end of the device projects out of the cavity when the front end is received in the pocket. Accordingly, when the device becomes free to pivot into a stable position, the front end pivots forward/down and the rear end pivots back/up so that the rear end is in a stable position projecting out of the cavity.
In addition, or alternatively, the front pocket may have various other features of its shape and/or construction that assist a user in withdrawing the device (or part thereof) from the cavity. The front pocket in the cavity may be generally formed to match the shape of at least the front end of the device when it is pivoted forward to a stable position. This can help to ensure that the front end of the device is protected by the front pocket and can make it difficult, if not impossible, for a user to get hold of the front end—contributing to safe aseptic technique. However the front pocket must also be shaped to accommodate pivoting motion of the device into a stable position where the front end is pointing down into the pocket. Preferably the front pocket comprises a curved wall arranged in front of the device, for example a curved wall that arcs back as the pocket deepens. Such a curved wall can generally follow an arc circumscribed by the front end of the device as it pivots forward into a stable position. The front pocket having such a shape means that it can accommodate pivoting of the device while helping to minimise the volume and material cost of the cavity.
Further preferably, or alternatively, the front pocket in the cavity may provide a surface that helps to guide the device as it is withdrawn from the package. Preferably the front pocket comprises an angled wall arranged behind the front end of the device. Such an angled wall may be arranged to contact the front end of the device when it is pivoted forward into a stable position. From this position, the device can be withdrawn from the package with its front end guided along the angled wall. This can help to ensure that the front end stays inside the front pocket, where it is protected, until the device is fully withdrawn from the cavity. It is therefore preferable that a wall of the cavity in the front pocket is angled forward and down from the fulcrum to provide a surface along which the front end of the device can slide. This promotes a no-touch technique in which the device is held by a rear end as it is pulled out of the cavity.
Further preferably, or alternatively, the front pocket in the cavity may include a catch arranged to hold the front part of the device once it has pivoted forward into a stable position. This may act to hold the front part in the front pocket, where it is protected, until a user actively pulls the device with enough force to release the front part. This can help to ensure that the device does not accidentally fall out of the package once the backing has been removed and any key parts at the front end remain sterile. Furthermore, in embodiments where the front end of the device comprises a removable cover e.g. for a needle or fluid transfer tip, the Applicant has recognised that it may be desirable for the cover to be retained in the package while the device is withdrawn. This can remove the need for a user to actively uncover the front end of the device after the device has been withdrawn from the package, eliminating this step to save time, and keeping the user's hands away from the front end where key parts may be located. In some examples, the front pocket may be arranged so that the front end of the device is automatically engaged by the catch after (or at the same time as) pivoting forward to a stable position.
In some examples, user interaction may be required for the front end to become engaged by the catch, e.g. after the device has pivoted forward to a stable position. The device may need to be pushed forwards and/or rotated in order to engage the front end with the catch. This may be particularly beneficial where the device comprises, or consists of, a needle hub carrying a needle and a needle cover. While the needle hub is still in the package, tilted forward for ease of access, a user can connect another device (such as a hypodermic syringe) to the needle hub and withdraw the needle while the needle cover is held back by the catch. The action of connecting onto a tapered needle hub, for example with a Luer slip connection, may push and/or rotate the needle cover into engagement with the catch.
The catch may be any suitable means for holding the front part of the device, for example using friction or positive engagement. The catch could take the form of a gripping aperture in the front pocket, an adhesive surface, a flange arranged to engage over the front part, a recess in a wall of the cavity, or any combination of such features. The catch may be provided by a separate insert in the front pocket or a wall of the cavity in the front pocket may be formed to provide the catch. In a set of embodiments a wall of the cavity in the front pocket includes a recess to provide the catch. Such a construction can make it easier for the cavity to be formed as a single piece e.g. of moulded plastics material.
The front end of the device becoming engaged and held in the recess can act to protect the front end. It is further preferable that a wall of the cavity in the front pocket is angled forward and down towards the recess so that the front end tends to becomes engaged in the recess. This angled wall in the front pocket may enable the front end to be automatically engaged with the catch, for example the device sliding forwards under its own weight into the recess at the same time as (or after) pivoting forward to a stable position. Or the angled wall in the front pocket may enable a user to push the front end forwards into the recess, to be engaged with the catch, after the device has pivoted forward to a stable position. In embodiments where the front end comprises a removable cover, it will be appreciated that the cover may then be held by the catch while the rest of the device is withdrawn from the cavity. This may be particularly beneficial where the device comprises, or consists of, a needle hub carrying a needle and a needle cover. While the needle hub is still in the package, tilted forward for ease of access, a user can connect another device (such as a hypodermic syringe) to the needle hub and withdraw the needle while the needle cover is held back by the catch. The needle then presents itself immediately as the device is withdrawn from the package. The retained needle cover can also work as a safety bin for the used needle after use—enabling safe recapping with one hand.
The Applicant has recognised that the feature of a catch which can hold onto the removable cover of a medical device does not necessarily have to be associated with the front pocket in the cavity. The front end of the device may be withdrawn and then a catch or other gripping means located anywhere in the cavity may be used to hold the cover once a user is ready to expose the key parts of the device. Thus, at least in embodiments where the front end comprises a removable cover, it is preferable that the cavity comprises means for gripping the removable cover. As is discussed above for the catch, such a gripping means may be provided by a separate insert in the cavity, or a wall of the cavity may be formed to provide the gripping means. In a set of embodiments a wall of the cavity includes a recess to provide the gripping means. Such a construction can make it easier for the cavity to be formed as a single piece e.g. of moulded plastics material.
This is considered novel and inventive in its own right, and thus when viewed from a further aspect the present invention provides a sealed package containing a medical device that comprises a removable cover, the package comprising a cavity containing the device, wherein the cavity comprises means for gripping the removable cover. Such a package preferably further comprises a removable backing that seals the device inside the cavity, as in the first aspect of the invention. Furthermore, any of the other preceding features described in the context of the first aspect of the invention may equally be applied to this further aspect of the invention.
The cavity and related features described above, such as the fulcrum and front pocket, may be provided by one or more separate parts. For example, the front pocket could take the form of an insert in a larger cavity and/or the fulcrum could be provided by an insert in the cavity. However, it is preferable that the cavity is integrally formed from a single piece of material, for example a blister moulded from a plastics material. Accordingly it is the shape of the cavity that preferably forms the front pocket and fulcrum. In a preferred set of embodiments the cavity comprises a central portion having a central depth and the front pocket is defined by a forward portion of the cavity having a depth that is greater. Further preferably, the central depth may substantially correspond to the diameter of the device. It will be understood that the “diameter” of the device can be defined generally as a dimension in the depth direction, for example if the device does not have a circular cross-section or generally cylindrical shape. The central depth substantially corresponding to the diameter of the device means that the cavity does not have any excess volume, other than that provided by the front pocket to enable the device to pivot forward.
In such embodiments, the fulcrum may be formed by a corner in a wall of the cavity between the front pocket and the central portion. The angled wall of the front pocket, discussed above, may extend forward and down from this corner. While the front pocket is designed to receive a front end of the device when it pivots forward into a stable position, the central portion can be designed to receive the device in an unstable position, i.e. an unpivoted or horizontal position. In addition, or alternatively, it is preferable that the device is supported in an unstable position by a wall of the cavity in the central portion. This supporting wall of the cavity is preferably the same wall that forms a corner with the front pocket to define the fulcrum, but of course one or more separate inserts could instead provide the supporting wall in the central portion.
In some embodiments the central portion of the cavity may extend back from the front pocket to contain a rear end of the device. However, in a preferred set of embodiments the cavity further comprises a rear pocket, with the central portion positioned between the front pocket and the rear pocket. The rear pocket may have a depth that is greater than the central depth of the central portion, but preferably not as deep as the front pocket. The rear pocket may be shaped to contain a rear end of the device. In embodiments where the medical device is a fluid transfer device, such as a syringe, the rear pocket may be shaped to contain one or more features of the rear end such as a plunger and/or finger grip. When the package is placed down on a surface, the cavity therefore comprises two points of contact spaced apart by the central portion. The front and rear pockets function to support the package on the surface. Furthermore, such an arrangement of different depth pockets helps a user to visually distinguish between front and rear ends of the package, so that they can pick up the package and peel open the backing at the rear end of the device. This is another feature that promotes safe aseptic technique.
In some embodiments the central portion may be substantially flat, in other words, extending in a substantially straight line between the front pocket and the rear pocket. However the Applicant has recognised that the central portion may beneficially provide an additional pocket that can be used to contain one or more other components associated with the device, for example a cap. Thus in at least some embodiments the central portion comprises a central pocket, preferably a central pocket having a depth that is less than the depth of the front pocket. In embodiments where the cavity also includes a rear pocket, as described above, the depth of the central pocket may me more or less than the depth of the rear pocket. When the package is placed down on a surface, the cavity may therefore comprise three points of contact that function to support the package on the surface: a first point of contact provided by the front pocket, a second point of contact provided by the central pocket, and a third point of contact provided by the rear pocket. This can make the package very stable when it is placed on a horizontal surface. Stability may be enhanced by ensuring that the outer surface of the central pocket is aligned with an outer surface of the rear pocket and/or front pocket. Preferably the central pocket and the rear pocket are aligned in a common plane so as to support the package on a surface while the front pocket may be tilted. Thus in a preferred set of embodiments the central pocket comprises an outer surface extending in a plane that is aligned with an outer surface of the rear pocket.
In a preferred set of embodiments the sealed package contains a medical device and an additional component for use with the medical device, for example a fluid transfer device and a cap for use with the device e.g. a cap to cover the fluid transfer tip so that it is protected from human touch even after the device is removed from the package. An advantage of containing the medical device and an additional component together in the same package is that they can be treated with a common sterilisation operation. The additional component may be contained in a further pocket provided anywhere in the cavity, for example a further pocket formed in the front pocket (or rear pocket, where provided), or a further pocket formed in the cavity separately from the front pocket (and/or rear pocket, where provided). The additional component is preferably contained in the central pocket, and preferably the additional component is wholly contained in the central pocket so as not to physically contact the device. The central pocket may be shaped to contain, and optionally grip, the additional component. The central pocket may be formed as a continuous three-dimensional shape, for example a hemispherical or cylindrical shape. In some embodiments the central pocket may be formed as a stepped or changing shape, for example comprising a first depth around a periphery of the pocket and a second, greater, depth in a central portion of the pocket. In addition, or alternatively, the central pocket may be tapered in shape. One or more of these features may assist the central pocket in gripping a component such as a cap. One or more of these features may assist in insertion and/or removal of the component.
It has already been discussed above how a user may pick up the package and hold it in a suitable orientation to remove the backing from a rear end, furthest from the front pocket. It has been recognised that the shape of the cavity may otherwise allow the device to move back and forth in the package, e.g. to slide longitudinally along the central portion, even if it is prevented from pivoting forward into the front pocket. However this may not be desirable, in case movement of the device risks damage to its front end and/or damage to the cavity. Accordingly, in a preferred set of embodiments a wall of the cavity is formed with an internal feature that abuts the device to prevent it from sliding forwards in the cavity. In embodiments where the cavity comprises a rear pocket, this internal feature may comprise a corner between the central portion and the rear pocket. Such a package preferably comprises a corner formed between the central portion and the rear pocket that is arranged to abut the device to prevent it from sliding forwards in the cavity. A rear end of the device, for example the finger grip of a syringe, may conveniently abut this corner so that longitudinal movement is not possible. This can prevent the front end, e.g. fluid transfer tip, from hitting a front wall of the cavity, protecting the tip from damage and avoiding forces that could tear open the package. Such an internal feature may thereby ensure that the front end of the fluid transfer is spaced from a wall of the cavity that forms the front pocket.
The Applicant has recognised that the shape of the central portion in the cavity can be used to provide further benefits when containing a device, for example a hypodermic syringe or other medical device that carries surface markings. The central portion may be arranged so that its walls are not fully in contact with the device. Preferably the central portion comprises side walls that support the device and a lower wall that is spaced away from the device. The lower wall may define a central pocket as described above. Further preferably the device comprises one or more surface markings that are positioned above the lower wall of the central portion, in particular printed markings. The lower wall being spaced from the surface markings on the device means there is no contact and friction tending to rub off the markings, for example if the package is exposed to vibrations during transit.
This is considered novel and inventive in its own right, and thus when viewed from a further aspect the present invention provides a sealed package containing a medical device that has printed markings on a surface thereof, the package comprising a cavity containing the device, wherein the cavity comprises side walls that support the device and a lower wall that is spaced away from the surface that has the printed markings. Such a package preferably further comprises a removable backing that seals the device inside the cavity, as in the first aspect of the invention. Furthermore, any of the other preceding features described in the context of the first aspect of the invention may equally be applied to this further aspect of the invention.
A cavity according to any of the aspects of the invention may have one or more further features as described below. The cavity preferably has an outer profile that follows the profile of the inner walls that contain the device, to save on material, although this is not necessary in all embodiments. The outer profile of the cavity may be shaped so as to determine how the package rests on a surface. For example, it is preferable that the removable backing forms an upper surface of the package when it is placed on a surface, for ease of access. In addition, or alternatively, the cavity can be shaped so as to ensure that the device will still tend to pivot when the package rests on a surface, preferably a generally horizontal surface such as a trolley. It is therefore preferable that the cavity has an outer profile below the device which is shaped such that, when the package rests on a horizontal surface, the predefined centre of mass of the device is forward of the fulcrum.
It has already been described above how an internal feature of the cavity may be arranged to abut the device to prevent it from sliding forwards and hitting a wall of the front pocket. More generally, the cavity may comprise one or more features (in addition, or alternatively) that are arranged to grip or otherwise hold the device, preferably holding the device in an unstable position at least until the backing is removed. As mentioned above, such features may ensure that the front end of the device is spaced from a wall of the cavity that forms the front pocket. Furthermore, the cavity may be shaped to fit around a given device and thereby prevent rotation while it is contained in the package. For example, the rear pocket (where provided) may be shaped to match the finger grip at a rear end of a hypodermic syringe and this prevents the syringe from rotating. This can also help to ensure that any surface markings remain spaced away from a wall of the cavity so they cannot be rubbed off.
The removable backing preferably comprises a film that is attached to the cavity 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 hold the sealed package in one hand and access a rear end of the device while the front end remains protected inside the cavity. This can be assisted by the backing comprising a tab arranged at an opposite end of the cavity to the front pocket. In some embodiments the backing may be arranged such that it can only be partially removed, e.g. peeled back far enough for the rear end of the device to project out of the cavity but the backing remains attached to the cavity. In other embodiments the backing may be arranged such that it is wholly removable from the cavity. This may be particularly desirable where a user wishes to unseal the package and tip out the device onto an aseptic field (such as a procedure trolley or portable tray) using a no-touch technique. Once the backing has been removed, the sterile interior of the cavity may even be used as a micro critical aseptic field.
It has already been mentioned above that, in preferred embodiments, the cavity 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 contained in the package before it is unsealed. The backing may also comprise a substantially transparent material for this reason.
In order for a user to be able to grip the package in one hand while using the other hand to remove the backing and withdraw the device, and for such gripping not to interfere with the automatic pivoting of the device, the cavity is preferably formed of a relatively stiff or hard material. In other words, it is preferable that the cavity is not manually deformable. In preferred embodiments where the cavity 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.
Although it is mentioned above that the cavity is preferably not manually deformable, there may be certain circumstances where it is desirable to be able to deform one or more walls of the cavity by applying a certain degree of force. For example, as will be described in more detail below, it may be beneficial to deform one or more walls of the cavity during a manufacturing process for the package so as substantially prevent the device from pivoting forward into a stable position until the removable backing has been applied. The cavity may therefore be formed of a relatively stiff material, that resists deformation when gripped manually, but a material that can still be deformed when gripped tightly enough e.g. before the package is sealed. The cavity is preferably formed of an elastic material that helps the cavity to return to its original shape after any deformation. The thermoplastic materials listed above may be found suitable in this respect. For example, the cavity may be formed of thermoplastic sheet material (e.g. PE sheet which is thicker and stiffer than PE film). The sheet material is preferably at least 0.2 mm, 0.3 mm, 0.4 mm or 0.5 mm thick. Such thermoplastic sheet material is thicker and stiffer than conventional plastic films as conventionally used to form soft packages for devices such as syringes.
While the package has so far been described in the context of a cavity containing the device, it will be appreciated that the package may comprise one or more such cavities. In at least some embodiments the package may comprise a plurality of such cavities, each containing a medical device and/or part of a medical device and/or component for use with the medical device. For example, such a package may contain both a needle and a hypodermic syringe in parallel—both devices being presented by tilting forwards into respective front pockets for safe handling with minimal risk of needlestick injury. For example, such a package may also contain a cap for the medical device—the cap preferably being presented in an orientation ready for connection. The removable backing could cover such multiple cavities and be lifted off in a single operation, presenting multiple device or components at the same time, e.g. vials, catheters, needles, syringes, etc. A common sterilisation operation may be applied to the device and other parts or components contained in the same package.
Sealed packages according to embodiments of the present invention may contain many different types of medical device. 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.
In a preferred set of embodiments the medical device comprises a fluid transfer device. The fluid transfer device may comprise any type of device used to transfer fluid—liquid and/or gas—either to or from a fluid receptacle. The fluid receptacle may be inanimate or it may be part of a living subject, for example a bodily cavity, organ or vessel, such as a vein or artery. For example, the fluid transfer device may comprise one or more of: a hypodermic syringe; a pre-filled syringe; an autoinjector; an insulin pen injector; an implant injector; a catheter; a catheter connector or valve; an IV delivery device; a blood collection tube; a Luer connector; a fluid vial; or any related accessory. A Luer connector may be connected to, or suitable for connection to, a fluid pump, stopper, closing cone, stopcock, aspirator, suction device, hose, or tubing. The fluid transfer device may be made to meet the relevant medical standard(s), for example ISO 7886 for sterile hypodermic syringes. A hypodermic syringe may have a volume of 2 ml, 5 ml, 10 ml, or 20 ml.
In a preferred set of embodiments the front end of the fluid transfer device comprises a fluid transfer tip, without or with a needle connected to the fluid transfer tip. The fluid transfer tip may be a key part that comes into contact (directly or indirectly) with a patient, such that it is desirable for the tip to be protected by the package. In one set of embodiments the fluid transfer tip may be needleless, for example the fluid transfer tip of a prefilled flush syringe. In another set of embodiments, the fluid transfer tip may include a needle. The needle may be integrated with the tip or permanently connected thereto, for example the injection needle of a prefilled single dose pouch or the needle of an auto-injector such as an epinephrine “EpiPen” or insulin pen injector. In other embodiments the fluid transfer tip may include a needle hub separably connected thereto. Such a needle hub may be connected to the fluid transfer tip of a variety of different devices such as a hypodermic syringe or catheter connector.
A sealed package according to embodiments of the present invention may be particularly well suited to containing a fluid transfer device that comprises a disconnecting member mounted at the fluid transfer tip. In a preferred set of embodiments the front end of the fluid transfer device comprises a fluid transfer tip and a lever member pivotally mounted relative to the fluid transfer tip. The lever member may be provided to assist in disconnecting the front end from a fluid transfer connection in use, for example 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. In such embodiments the cavity may be able to protect the lever member from accidental activation during transport. The weight of the lever member can ensure that the fluid transfer device quickly reaches a stable (i.e. fully tipped) position, for example after only a small amount of the backing is removed. A fluid transfer device that comprises a lever member has been found to reduce the risk of hand contamination when detaching a medical device interface, e.g. disconnection of a syringe from an IV cannula with an injection port (for administration of fluid), e.g. disconnection of a syringe from an IV port, e.g. withdrawal of a needle following fluid preparation or injection. Disconnection using a lever member significantly reduces the risk of needlestick injury, improves no-touch technique and reduces the risk of key part contamination. The lever member moves a user's hand away from proximity to the key parts, and visually reinforces protection of the key parts, at the front end. Furthermore, single-handed operation provides users with a free hand—which can be particularly helpful in anaesthetic and emergency scenarios.
The 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 finger, 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 more viscous fluids.
The fluid transfer tip may connect, in use, to one or more of: a fluid transfer hub connected to an interface for intravenous (IV) medication, i.e. an IV port, a needle for fluid preparation or administration, a cannula port, or a wing infusion set. It will be appreciated that the fluid transfer tip is received in the front pocket of the cavity when the device is free to pivot forward, this key part then being protected while a rear end of the device is presented to a user. This helps to ensure that the fluid transfer tip is kept sterile and protected from contamination. A user may easily grasp the rear end of the tilted fluid transfer device and, in embodiments where the package also contains an additional component such as a cap in a further pocket, the fluid transfer tip may be connected to the additional component in a single one-handed operation. In various embodiments the fluid transfer device is a hypodermic syringe. In such embodiments the rear end of the fluid transfer device may comprise a plunger, which is preferably received in the rear pocket (where provided).
The contents of the Applicant's prior publications WO 2013/164358, WO 2014/020090 and WO 2015/014914 are hereby incorporated by reference. In a preferred set of embodiments, the lever member comprises a front surface that is substantially transverse to the axis of the male connector tip and one or more side surfaces that extend in a direction substantially parallel to the axis of the male connector tip, the front surface being moveable along the male connector tip between a first position proximal to the fluid chamber and a second position spaced from the first position towards a distal end of the male connector tip, wherein the side surface(s) form a shroud extending back from the front surface towards the fluid chamber and thereby at least partially surround the fluid chamber. Such fluid transfer devices are able to provide single-handed operation and precise disconnection power.
In a set of embodiments a cap for the fluid transfer tip is also contained in the cavity, separately from the fluid transfer device, in a further pocket and preferably in a central pocket as described above. By providing a cap for the fluid transfer tip in the same sealed package as the fluid transfer device, aseptic procedures can be promoted as a user may insert the tip into the cap as soon as the package has been opened, thereby avoiding one or more risks of contamination that typically arise from a user touching (e.g. accidentally) the tip, or from the tip coming into contact with non-aseptic fields or surfaces in the surroundings, or from air contaminants. The cap may then protect the fluid transfer tip until such time as a user is ready to connect the tip to another component, such as a needle hub or IV port.
In a set of embodiments a needle hub is connected to the fluid transfer tip. The needle hub preferably comprises a needle and a removable needle cover. A lever member as described above may be provided to assist in disconnecting the needle hub from the front end of the fluid transfer device. In other embodiments, the package may contain a sheathed needle alone. In such embodiments the medical device may consist of a needle hub, carrying a needle, and a needle cover. The needle cover is preferably a removable cover that can be gripped by the cavity, for example by a dedicated recess provided in the cavity, to assist in removing or replacing the cover as described above.
In 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 devices 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 the description above, when the medical device is said to be in a stable position, this is considered to be the natural position of the device were it to be placed in the cavity with no other forces acting on the device or the cavity so as to counteract the force of gravity acting through the predefined centre of mass to effect pivoting about the fulcrum. The device is considered to be in an unstable position when it is moved out of its stable position by one or more forces acting to counteract the force of gravity and prevent the device from pivoting freely about the fulcrum. In preferred embodiments described above, the device may be held in an unstable position by the backing that seals the device inside the cavity. However, at any point in time there may be alternative or additional forces acting on the package so as to substantially prevent the device from pivoting forward into a stable position.
During manufacture of the sealed package, typically a medical device would be placed into the cavity of the package before applying the removable backing. Due to the position of front pocket and the fulcrum, this would typically allow a front end of the medical device to pivot forward within the cavity. Depending on the length of the device relative to the depth of the cavity, such pivoting may cause a rear end of the device to project out of the cavity and this could interfere with application of the backing. For example, in embodiments where the medical device comprises a syringe, the plunger of the syringe may protrude from the cavity. It is generally desirable to minimise the depth of the cavity so as to reduce material cost for the package. It may be desirable to prevent the medical device from pivoting in the cavity at least during the manufacturing step of sealing the package.
Therefore in a preferred set of embodiments the package further comprises a support arranged outside the package to deform the cavity so as to substantially prevent the device from pivoting forward into a stable position inside the package. This is advantageous as the support may hold the device horizontally within the cavity so that the backing can be applied without any obstruction from the pivoted device. This ensures that the backing can be tightly sealed to the cavity of the package, which is advantageous over a loose backing which may permit the device to move undesirably within the package.
Such a support may be substantially rigid, for example to ensure that sufficient force is applied to deform the cavity. However it may be difficult to apply a rigid support to the outside of the package. Thus, in some embodiments, such a support may be flexible, e.g. springy, so as to apply a resilient force to deform the cavity. For example, the support may comprise a flexible clip e.g. to assist in attachment of the support to the outside of the package. The support may take the form of a generally U-shaped clip. The support may be made from an elastic metal or plastics material.
In a further preferred set of embodiments the support is arranged to deform one or more walls of the front pocket. Deforming the walls of the front pocket reduces the volume of the front pocket and prevents the medical device from pivoting into the pocket. By deforming the walls of the front pocket the support can also be advantageously positioned such that it does not interfere during application of the backing to the cavity. Once the backing has been applied to seal the package, it may be desirable to remove the support. Accordingly the support is preferably removable. For example, the support may be applied to the package before attaching the backing, then removed after the sealing process is complete and before the package is shipped or supplied to a user.
It will be appreciated that deformation of the cavity achieved by the support is preferably a temporary or elastic deformation so that the cavity automatically returns to its intended shape and form once the support is removed. Accordingly the support is constructed so as not to cause a plastic deformation of the cavity. Preferably the cavity returns to its original shape when the support is removed. The contained device is therefore only prevented from pivoting forward during the time that the support is applied to the outside of the package. As is mentioned above, such a temporary support may be particularly useful when the package is being sealed. This is considered novel and inventive in its own right.
According to a further aspect of the invention there is provided a method of sealing a package containing a medical device that has a predefined centre of mass, the package comprising: a cavity containing the medical device; a fulcrum within the cavity, defined as a point of contact between the device and a wall of the cavity, the fulcrum being positioned such that the predefined centre of mass of the device is forward of the fulcrum so that the device tends to pivot forward about the fulcrum into a stable position; and a front pocket formed in the cavity which extends forward of and below the fulcrum to receive a front end of the device when the device is free to pivot into a stable position, the method comprising: deforming one or more walls of the cavity such that the medical device contained in the cavity is supported on the fulcrum in an unstable position; and applying a removable backing to seal the cavity.
According to such a method the medical device is supported such that it cannot pivot forward about the fulcrum into a stable position and hence the front end is not received in the front pocket and a rear end of the device does not tend to protrude out of the cavity and interfere with application of the backing. As is described above, deforming the cavity preferably comprises deforming one or more walls of the front packet. Preferably the deformation is elastic. In such a method, the step of deforming the cavity may take place before or after containing the medical device in the package.
In preferred embodiments, the step of deforming one or more walls of the cavity comprises arranging a support outside the package. A suitable support may have any of the features described above.
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:
Also shown in
The syringe 4 contained in the package 2 comprises a plunger 18, a barrel 20 with scale markings 22, a fluid transfer tip 24 and a lever member 26 which is mounted around the fluid transfer tip 24. It can be seen that the front pocket 10 has a depth which is greater than that of the central portion 12. It can be seen that the syringe 4 pivots about a fulcrum 32 formed where the surface of the barrel 20 comes into contact with a corner in the cavity wall where the central portion 12 drops down into the front pocket 10 of the cavity 6. In the embodiment shown, as the lever member 26 is positioned around the fluid transfer tip 24, due to the mass this adds in the region proximal to the fluid transfer tip 24 it is evident that the centre of mass is forward of the fulcrum 32.
As seen in
The front pocket 10 within the cavity 6 is illustrated by the dashed region on
Another issue associated with the packaging of medical devices, such as the syringe 4 contained in a blister-type packaging 2, is that both high and low frequency vibrations which arise during storage and transportation can cause markings 22 on the device to wear away.
As seen in
In the embodiments shown the cavity 6 is formed from a single piece of plastic with an internal structure which provides the fulcrum 32. However it will be appreciated that this may be achieved by alternative means, for example a less structured blister package could be used and an insert could be placed into the cavity of the blister package to provide the fulcrum.
Although it has been identified that it is advantageous for the plunger end of the device to protrude from the cavity when the backing is removed, it will be appreciated that in certain situations it may be advantageous for the fluid transfer tip to protrude from the cavity. In such situations the pivot point could be arranged so that this would tend to happen. It will also be appreciated that the syringe or other medical device may, additionally, be able to adopt one or more positions in the package where it does not tend to pivot. For example, the device may be able to slide within the cavity of the package. In such a scenario a user would be able to first peel away the backing to open the cavity and then tilt the package slightly such that the centre of mass of the device moves forward of the fulcrum, thus causing the device to pivot and present one end.
Although in the embodiments shown the syringe 4 is removed from the package 2 whilst the package 2 is still being held in a user's hand, it is also envisaged that the backing 8 could be removed and the package 2 could be subsequently placed on a surface at which point the syringe 4 may be removed.
In the embodiments shown the backing 8 is sealed around a peripheral portion 28 of the top surface of the cavity 6 and when it is peeled away it is left in contact with one end of the cavity 6. However it will be appreciated that the backing may be completely removed from the device or may be attached or sealed by other suitable means. For example it may be designed such that only part of the backing is able to be peeled away to ensure that the fluid transfer tip remains in at least a partially sealed portion such that the user is only able to grab the plunger end of the syringe.
In the embodiments shown the syringe 4 comprises a lever member 26 which substantially affects the position of the centre of mass. It will be appreciated that the packaging can be used with other medical devices which do not comprise a lever member, in such cases the fulcrum is appropriately positioned such that the centre of mass can fall within the front pocket of the package thus allowing the medical device to pivot.
After the syringe 180 has been used for a medical procedure, the needle hub 160 can be safely recapped with the needle cover 170 that is retained in the original package 102, as shown in
There is seen in
In
Another embodiment of a package 302 is seen in
The central pocket 312 may be used to contain another component separately from the medical device, for example a cap for the device. As soon as the package is opened, a device contained in the cavity 306 will pivot forward into the front pocket 310, as previously described, so as to present its rear end to a user. If the device is not to be used straightaway for a medical procedure, then a user can grasp the device at its rear end to remove it from the cavity 306 and then push the front end of the device down into engagement with the cap (or other component) contained in the central pocket 312. The central pocket 312 may be shaped to grip the cap, for example so that the device can be twisted where the cap requires a screw connection. The front end of the device, which may for example comprise the fluid transfer tip of a syringe, does not come into contact with the user or the external environment and can be kept sterile while covered by the cap. The package 302 therefore provides a complete solution ensuring that the aseptic technique is not compromised.
While different variants of a package and cavity have been described separately above, it will be understood that a single package could combine one or more such cavities, for example with a shared backing. For instance, a package could include one cavity for a needle hub and another cavity for a syringe, or one cavity for a catheter and another for a catheter connector.
When sealing a package that contains a medical device such as a syringe, a potential problem is that the device may tend to pivot within the package such that its rear end e.g. the plunger of a syringe protrudes from the cavity. The protruding plunger can interfere when applying the backing which seals the package. This can be overcome by including a step within the sealing process which supports the device in an unstable e.g. horizontal position such that it does not pivot forward with its rear end protruding from the cavity. This can be achieved in many ways, but in the following Figures and discussion a U-shaped clip is described which supports, e.g. lifts and holds, a syringe in a horizontal position in a package.
The flared shape of the U-shaped clip 60 is particularly advantageous as the motion of the cavity 6 being pressed onto the U-shaped clip 60 assists in pushing the syringe 4 upwards. If for instance the side walls of the cavity 6 were just pressed inwards, this may not necessarily cause the syringe 4 to pivot upward and instead it may just hold it in place in a stable position.
Although it is shown that the syringe 4 is contained within the cavity 6 and then the U-shaped clip 60 is attached it may be possible for the cavity 6 to be deformed by applying the clip 60 before the syringe 4 is placed into the cavity 6. This would mean that the syringe 4 is inserted into the cavity 6 and is instantly supported in a horizontal position.
Although the U-shaped clip 60 is shown to be positioned on the front pocket 10, it is envisaged that it could be positioned anywhere on the cavity 6 such that it causes deformation resulting in the syringe 4 being supported in an unstable horizontal position within the cavity 6.
It will be appreciated that the U-shaped clip 60 may form part of a machine in the manufacturing process and depending on the type of machine there may also be an array of such U-shaped clips 60.
Although the U-shaped clip 60 is discussed with reference to a manufacturing and sealing process for the package 2, it is envisaged that it could be utilised for other purposes. For example the U-shaped clip 60 could remain attached to the front pocket 10 of the cavity 6 until the user wishes to release the syringe 4. In such an example the user may peel away the backing 8 and the U-shaped clip 60 may hold the syringe in place until the user wishes to remove the syringe 4. When the user wishes to remove the syringe 4 he may then simply remove the U-shaped clip 60 so that the syringe 4 is free to pivot forward into a more stable position.
| Number | Date | Country | Kind |
|---|---|---|---|
| 1507696.1 | May 2015 | GB | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2016/060134 | 5/5/2016 | WO | 00 |
