WO2024110767A1

WO2024110767A1 - Needle support device and kit for delivery of radiopharmaceutical medicament

Info

Publication number: WO2024110767A1
Application number: PCT/GB2023/053073
Authority: WO
Inventors: Philip Jake COHEN; Shaunak NAVALKISSOOR; Martyn Evan CAPLIN
Original assignee: Wellnet Ltd
Current assignee: Wellnet Ltd
Priority date: 2022-11-25
Filing date: 2023-11-27
Publication date: 2024-05-30
Anticipated expiration: 2025-05-25
Also published as: EP4637669A1; GB2624666A; GB202217650D0

Abstract

The present disclosure relates to a delivery support device of particular application in radiopharmaceutical therapies, such as radioligand therapies. The invention provides a needle support device (32) for use with a container (14) for a vial (10) of radiopharmaceutical medicament (12), the needle support device (32) comprises: a body (36) arranged to locate on a top of a container (14), in use, and having a proximal side (36a) located towards a container (14) to which the device is attached, in use, and a distal side (36b) located away from a container (14) to which the device is attached, in use, - a first guide channel (38) extending through the body (36) for receiving a first needle (18), the first guide channel (38) defining a first guide axis (A1) for a needle shaft, and a second guide channel (40) extending through the body (36) for receiving a second needle (22), the second guide channel (40) defining a second guide axis (A2) for a needle shaft, wherein each of the first and second guide channels (38, 40) comprises a proximal opening (38a, 40a) at the proximal side (36a) of the body (36) and a distal opening (38b, 40b) at the distal side (36b) of the body (36), a needle guide section (54) terminating at the proximal opening (38a, 40a) and being arranged, in use, to accommodate a shaft of a needle received within the first or second guide channel (38, 40), a needle hub support section (58) terminating at the distal opening (38b, 40b) and having a diameter larger than a diameter of the needle guide section (54), the needle hub support section (58) being arranged to accommodate a hub (60) of a needle received within the guide channel.

Description

Needle support device and kit for delivery of radiopharmaceutical medicament

The present invention relates to a delivery support device for use in the delivery of pharmaceuticals to a patient by intravenous infusion and in particular, but not exclusively, to a device for facilitating the safe delivery of radiopharmaceutical medicaments. The invention further relates to a kit for use in the delivery of a radiopharmaceutical medicament.

Radiopharmaceutical therapies involving the administration of medicaments containing radioactive substances, such as radioligand therapy, are well established in the medical field. Such therapies are of increasing importance in oncology, in particular, with the number of oncological treatments employing radiopharmaceutical medicaments expected to grow exponentially across the world.

Radiopharmaceutical medicaments typically require administration to a patient via intravenous infusion. However, administration of radiopharmaceuticals in a manner which is safe to both the patient and the medical professional administrating the therapy is a particular challenge. Accidental exposure the radioactive substance is a particular risk to the medical professional charging out the administration.

Pharmaceutical drugs are commonly provided in a vial and would usually be removed by syringe for delivery to the patient. However, such delivery methods are not appropriate in the case of radiopharmaceutical medicaments due to the significant risk of exposure to the patient and the medical professional. The medical professional is at particular risk of receiving an accidental dose of the radiopharmaceutical medicament when preparing equipment for delivery to the patient. There is currently no standardised delivery system for radiopharmaceutical therapies contained in a vial, leading to inconsistent administration techniques and therefore increased risk. This may also compromise the clinical outcomes of the therapy, for example due to the drug being delivered at inconsistent flow rates.

In order to improve safety, vials of radiopharmaceutical drugs are commonly supplied within a protective container, commonly referred to as a “vial shield”. The vial shield is formed of a material or materials that shield the user from radioactive admissions. One such container is disclosed in US 7842023 B2. The container comprises a cavity for receiving a vial of radiopharmaceutical drug and a lid having a central aperture, permitting access to a septum of the vial for extraction of the radiopharmaceutical using a syringe, for example. In practice, a further cap would be used to seal the central aperture of the container to ensure that any handlers are safely shielded from the radioactive substance contained therein during transport and storage of the vial.

However, extraction of the radiopharmaceutical from the vial for delivery to the patient still presents a number of safety risks. One common method of administration involves the use of a saline vector fluid, which is pumped into the sealed vial via a needle extending through the central aperture of the vial shield container. The needle pierces a septum of the vial and extends into a headspace within the vial. An infusion pump is used to transfer saline solution into the vial through the needle to create a positive pressure within the vial. The radiopharmaceutical drug is thereby driven out of the vial through a further needle, which is arranged to extend through the central aperture of the protective container and the septum of the vial, below the level of liquid within the vial. The further needle is connected to an appropriate cannula, permitting the radiopharmaceutical drug to be delivered to the patient intravenously. This method is hereafter referred to as a ‘positive pressure’ method. Whilst this method avoids the use of a manual syringe, and thus improves safety for the medical professional administrating the therapy, there are a number of deficiencies associated with the method.

Since the technique relies on the build-up of a positive pressure within the vial, the pressure within the vial can accumulate in the event in an occlusion downstream of the vial. In the event that the occlusion is released suddenly (e.g. as a result of a patient moving their arm), a sudden increase in the rate of the delivery of the drug to the patient can occur and thus the overall rate of delivery of the drug to the patient can be uneven and difficult to control. Infusion pumps used to deliver saline solution into the vial are commonly equipped with occlusion detection to detect such pressure rises, however this is often not effective due to the relatively small pressures involved, which may still be enough to cause changes in the flow rate of the drug being delivered to the patient. Occlusions may also occur where a needle pivots under the weight of the attached components and comes into contact with an internal side wall of the vial.

Similarly, if patients do not have free flowing veins, the above method may also result in difficulties in precisely controlling the flow rate of the drug to the patient. Such variations in flow rate are often the cause of infusion related reactions in the patients and it is therefore desirable to maintain careful control over the flow rate.

Additionally, even where a predictable and even flow rate is achieved, drug infusion cannot be delivered at a fixed rate using the above method, since the drug within the vial is progressively diluted over the course of the administration. That is, the concentration of the drug being delivered to the patient gradually decreases over time. Accordingly, the medical professional carrying out of the administration is required to gradually taper the rate of delivery. This adds complexity to the delivery method, requiring more time and attention from the medical professional, thus preventing the medical professional from carrying out other duties.

A further problem associated with such methods is that if needles do not form a perfect seal with the vial septum, the fluid level within the vial can rise, eventually leading to overflow of the drug. This poses a risk to both the medical professional through radiation exposure and the patient, since the quantity of drug delivered following a leakage event is no longer known.

Such complications can often lead to the need for manual intervention involving the use of a syringe to manually extract the radiopharmaceutical and deliver it to the patient by hand. Accordingly, the risk to the medical professional increases and ultimately may result in an incomplete dose of the radiopharmaceutical drug being delivered to the patient.

Generally, the complex nature of the delivery of radiopharmaceuticals, even where a protective vial shield is used, requires highly specialised delivery teams in centralised locations. This limits the number of patients that have access to such treatments.

Accordingly, there remains a need for a simple and standardised means for delivery of radiopharmaceutical drugs to patients, which ensures the safety of both the patient and the medical professional, lowers the risk of infusion related reactions in the patient and lowers the complexity of the administration.

The present invention seeks to overcome the abovementioned issues. In accordance with a first aspect of the present invention, there is provided a needle support device for use with a container for a vial of radiopharmaceutical medicament, the needle support device comprising: a body arranged to locate on a top of a container, in use, and having a proximal side located towards a container to which the device is attached, in use, and a distal side located away from a container to which the device is attached, in use, a first guide channel extending through the body for receiving a first needle, the first guide channel defining a first guide axis for a needle shaft, and a second guide channel extending through the body for receiving a second needle, the second guide channel defining a second guide axis for a needle shaft, wherein each of the first and second guide channels comprises: a proximal opening at the proximal side of the body and a distal opening at the distal side of the body, a needle guide section leading to the proximal opening and being arranged, in use, to accommodate a shaft of a needle received within the first or second guide channel, and a needle hub support section having a diameter larger than a diameter of the needle guide section, the needle hub support section being arranged to accommodate a hub of a needle received within the guide channel. In use, the needle hub support section provides lateral support to a needle hub received therein, so as to maintain an orientation of said needle along the first or second guide axis.

The needle support device provides a support for needles for use with a system for the delivery of radiopharmaceutical medicament to a patient. In use, first and second needles are inserted into the first and second guide channels, respectively. A shaft of the first needle extends along the first guide axis on at least the proximal side of the body. A shaft of the second needle extends along the second guide axis on at least the proximal side of the body.

In use, the body of the device is arranged to locate on a top of a container so as to provide a stable support for needles inserted into the container. The body thus provides a platform for supporting needles in a desired, fixed position and orientation relative to the container. The body may be arranged to engage with a top of the container so as to extend, at least partially, over the top of the container. Alternatively or additionally, the body may locate within an aperture provided in the top of the container. Alternative means for securing the body in a fixed position relative to a top of the container and in proximity thereto will be conceivable to the skilled person.The needle guide section is arranged to accommodate a shaft of the needle in a close-fitting relationship, so as to support the needle shaft and ensure the shaft extends on the proximal side of the body along a predefined guide axis (i.e. along the first or second guide axis, depending on which guide channel the needle is inserted into). This ensures that each needle enters a septum of a vial contained within a container to which the device is fitted at a desired, predefined position and angle. It will be appreciated that, in use, a portion of the needle shaft may also be positioned on the distal side of the body, depending on the configuration of the needle guide channels and thus may partially extend on the distal side of the body along the same guide axis.

Each guide channel additionally comprises a needle hub support section adjoining the needle guide section and being arranged to accommodate a hub of the needle inserted into that guide channel in a close-fitting relationship. A diameter of the needle hub support section is larger than that of the needle guide section so as to accommodate the needle hub. The needle hub support section is arranged to provide lateral support to the needle hub, thus preventing lateral movement of the needle hub in a direction having a component orthogonal to the first or second guide axis. With this arrangement, in use, the orientation of the needle is maintained along its entire length. This prevents any load acting on the needle hub from being transferred to the vial septum vial the needle shaft. For instance, the weight of any cannulas connected to the needles is supported by the rigid needle hub support sections rather than being transferred to the vial septum. This prevents distortion of the vial septum and bending of the needle shaft.

The needle support device preferably comprises attachment means for releasably attaching the needle support device to a container so as to locate the body on a top of said container, wherein the body is in a fixed position relative to the attachment means.

The attachment means allow the needle support device to be secured onto a container in a stable relationship to prevent relative movement between the needle support device and the container during the treatment, without the need for other external mounting equipment. Skill and preparation time required for setting up the treatment is therefore reduced. The body of the needle support device is in a fixed position relative to the attachment means when the needle support device is secured/attached to the container by the attachment means, such that when the device is secured to a container by the attachment means, the first and second guide channels remain in a fixed position relative to the attachment means and, therefore, relative to the container to which the device is attached. This ensures that the guide channels provide a stable support for needles received therein. In particular, the guide channels (including the needle guide section and needle hub support section) are not movable in an axial direction when the device is attached to a container, ensuring that the first and second needles remain in the desired position for the duration of the procedure. The arrangement also provides a simple mechanism for enabling a user to insert needles in the correct positions.

The attachment means are preferably operable at a location remote from the body of the needle support device and therefore remote from a top of the container, in use.

The attachment means may comprise first and second resilient arms provided on opposing lateral sides of the body and extending proximally from the body to engage with opposing sides of a container, in use. The resilient arms are biased to a position in which they engage with the container to secure the needle support device on the container, whilst being permitted to flex away from the container for attachment or removal of the needle support device. This provides a facile means for attaching the needle support device to the container in a secure arrangement.

The first and second resilient arms may further comprise lever portions extending distally from the body. The lever portions are arranged to effect movement of the resilient arms against their bias to increase the separation between the resilient arms at a location proximal to the body, allowing the needle support device to be easily installed onto and removed from the container. The user can therefore effect separation of the resilient arms with a simple single-handed action. Since the lever portions extend distally from the body, the position at which the user interacts with the needle support device is remote from the body, and concurrently remote from the top of the container, which minimises the risk of the user accidentally coming into contact with any radiopharmaceutical medicament that may have leaked from the vial septum. Safety to the user is thereby improved.

Preferably, each of the first and second resilient arms is joined to the body by a living hinge. This reduces the number of separate components required to manufacture the needle support device. In particular, the needle support device may be formed as unitary component by injection moulding, for example. Each of the first and second resilient arms may comprise a hooked portion at a proximal end thereof. This permits easy engagement of the needle support device with a stepped portion of the outer circumference of the container.

Typically, the central aperture of a vial shield container (for which the present invention is intended for use) is made relatively small in order to minimise exposure to the user. Accordingly, in order to ensure that both needles can enter the vial septum located beneath the central aperture of the container, it is necessary for the needle shafts to be in close proximity to each other at a location beneath the central aperture of the container. However, the proximity of the needle shafts is limited to an extent by the diameters of the needle hubs and any components connecting thereto. Even where the distance between the respective needle hub support sections of the first and second guide channels is minimised, the minimum distance between the needle shafts is limited in a manner determined by the required separation of the needle hubs when received with the respective needle hub support sections. The minimum distance between the needle shafts, if installed in a parallel relationship, may be greater than the diameter if the central aperture of the container and/or the diameter of the vial septum, which would prevent both needles simultaneously extending through the central aperture and/or vial septum.

Therefore, in some embodiments of the present invention, the second guide axis is set at a predefined, non-parallel angle with respect to the first guide axis. This allows the needle hubs to be supported within the needle hub support sections in a side-by-side arrangement, whilst at the same time ensuring that the needle shafts are in sufficient proximity to extend through the central aperture of the container and the septum of a vial contained therein. This also ensures that any components of the delivery system connecting to the needle hubs (e.g. cannula connectors and/or adaptors), which can typically be relatively bulky, are directed away from each other. Accordingly, the arrangement of the present invention ensures that both needles can be fully supported whilst still permitting access through a relatively small central aperture of a vial shield container.

The present invention thus provides a safe, repeatable and reliable means for extracting a radiopharmaceutical medicament from a vial contained within a vial shield container, which minimises the skill and preparation time required to set up the equipment and reduces the risk of distortion of the vial septum by the needle shafts, in turn reducing the risk of radioactive medicament leaking through the vial septum. By reducing the complexity of the delivery system, the need for highly specialised delivery teams in centralised locations is obviated. The availability of such treatments can therefore be significantly increased.

Preferably, the needle hub support section of the first and/or second guide channel tapers towards the needle guide section. That is, a diameter of the needle guide section gradually reduces towards the needle guide section. In use, a needle shaft inserted into the guide channel is directed towards the needle guide section by the tapered portion of the needle hub support section. This assists in locating the needle shaft in the needle guide section of the guide channel, reducing the skill and preparation time needed to set up the treatment.

In preferred embodiments, the angle of taper of the needle hub section increases towards the needle guide section. In some embodiments, the needle hub support section comprises a substantially cylindrical portion for providing lateral support to the needle hub, in use, and a tapered portion leading to the needle guide section, wherein the angle of taper of the tapered portion is greater than the angle of taper of the substantially cylindrical portion, such that the tapered portion directs the needle shaft towards the needle guide section. The substantially cylindrical portion of the needle hub support section may have a constant diameter about the first or second guide axis. However, in alternative embodiments the substantially cylindrical portion may have a shallow angle of taper, provided the angle of taper is less than that of the tapered portion and is such that the substantially cylindrical portion provides lateral support to a needle hub received therein. For instance, where the needle support device is formed by injection moulding, the substantially cylindrical portion may have a shallow angle of taper corresponding to the draft angle dictated by the injection moulding process.

The tapered portion preferably tapers in a linear manner towards the needle guide section, but may alternatively taper in a non-linear manner. For example, the tapered portion may have a substantially concave or convex form, or the angle of taper may increase or decrease along the respective guide axis of the first or second guide channel. In particular, the angle of taper of the tapered portion may become shallower in the vicinity of the needle guide section. A maximum diameter of the needle guide section along the first or second guide axis is preferably in the range 0.17 mm to 3.5 mm and more preferably in the range 0.4 to 1 .3 mm.

A maximum diameter of the needle hub support section along the first or second guide axis is preferably in the range 2.5 mm to 8 mm and more preferably in the range 5 mm to 6.5 mm.

The body may comprise a substantially planar base arranged, in use, to engage with an upper surface of a container, and the first guide axis is substantially perpendicular to a plane of the base of the body. With this arrangement, in use, the needle support device can be located on a container by placing the planar base on the top of the container, which also typically will have a substantially planar form. A needle inserted into the first guide channel is oriented along the first guide axis, such that the needle shaft extends from the proximal side of the body substantially at right angles to the top of the container and, consequently, substantially at right angles to a septum of a vial contained within the container. In this regard, it will be appreciated that containers for which the present invention is intended for use will typically be arranged to have a substantially planar top surface and such that a vial contained within the container will be in an upright orientation, wherein the vial septum is substantially parallel with the planar top surface of the container.

The second guide axis is set at an angle preferably in the range 1 to 45 degrees, and more preferably in the range 5 to 20 degrees, with respect to the first guide axis. This ensures the necessary proximity of the needle shafts, whilst also permitting both needle hubs to be supported by the respective needle hub support sections in a side-by-side manner, as described in detail above.

The needle support device may comprise a shield member adjoining the body, the shield member being arranged, in use, to cover at least a portion of an aperture located in a top of a container to which the needle support device is attached. The shield member therefore protects the user from accidental leakage of the radiopharmaceutical medicament through the vial septum and out of the central aperture of the container. This may occur, in particular, as the needles are removed, since the positive pressure within the vial may cause spray-back of the medicament. Preferably, the shield member is arranged such that at least a portion of said aperture remains exposed when the needle support device is attached to said container, in use. With this arrangement, the central aperture of the container and the vial septum can still be accessed in the event that a manual intervention is required during the treatment. For example, in the event of an occlusion downstream of the vial, transfer of the radiopharmaceutical medicament by an infusion pump may be interrupted, requiring manual administration of the medicament to the patient by syringe. Ensuring that a portion of the central aperture of the container remains accessible when the needle support device is attached allows such contingency methods to be used, if necessary, without first having to remove the needle support device from the container. Ease of use is thereby improved. The exposed portion of the central aperture can be covered using an appropriate protective element, such as a tissue, whilst removing the needles or otherwise interacting with the needle support device.

In order to achieve this, in an embodiment arranged for use with a container having a central aperture of a particular shape, the shield member and the body, in combination, define a cover arranged to extend over the aperture of the container and having a shape corresponding to the shape of said aperture, wherein a portion or segment of the cover is absent. For example, in one particular embodiment arranged for use with a container having a circular central aperture, the shield member and the body, in combination, define a substantially circular cover arranged to extend over the circular aperture of the container, wherein a portion or segment of the substantially circular cover is absent. Accordingly, the absent portion of the cover ensures that a portion of the central aperture of the container remains exposed when the needle support device is fitted to the container. It will be appreciated, however, that the shape of the cover defined by the shield member and body, in combination, will depend on the shape of the central aperture of the container for which the device is intended for use.

In some embodiments, the shield member comprises a substantially semi-circular projection extending laterally from the body. Preferably, no lateral projection is present on an opposing side of the body. Accordingly, in use, a portion of the central aperture is covered by the shield member on one side of the body, whilst a portion of the central aperture on the opposing side of the body remains uncovered. The needle support device may further comprise one or more locating members projecting from a proximal side of the body, the locating members being arranged to engage with an internal circumference of an aperture of a container so as to locate the needle support device on said container, in use. This provides accurate alignment of the needle support device, and thus any needles supported thereby, with the container aperture and the underlying vial septum.

The or each locating member comprises a tapered projection having an outside edge arranged to taper inwardly towards a centre of the needle support device. In use, the tapered outside edge of the locating member bears against the inner circumference of the container aperture and guides the needle support device to a centred location relative to the container aperture. The tapered outside edge of the locating member also allows the needle support device to be accurately aligned with containers having central apertures of different diameters.

The needle support device preferably comprises two locating members arranged on opposing sides of the first and second guide channels, such that the first and second guide channels can be aligned with the central aperture, allowing needles inserted through the first and second guide channels to extend through the central aperture of the container for access to the vial contained therein.

In one particular embodiment, the needle support device comprises two locating members located on opposing sides of the first and second guide channels, wherein each locating member comprises a tapered projection having an outside edge that tapers towards a common central axis of the needle support device. The central axis of the needle support device is to be interpreted as an axis coinciding with a central vertical axis of the container aperture, in use. Accordingly, the tapered projections can engage with opposing sides of a central aperture of a container to locate the first and second guide channels into alignment with the central aperture of the container. Depending on the extent of the tapered outside edges, central apertures of a range of diameters can be accommodated.

The or each locating member may alternatively or additionally comprise a projection having a pair of opposing chamfered edges. The chamfered edges can again engage with the inner circumference of a container aperture, so as to guide the needle support device into correct alignment with the central aperture. The two opposing chamfered edges of the or each locating member may lie in a plane that does not intersect a central axis of the needle support device. Accordingly, the two opposing chamfered edges of the or each locating member engage with opposing points around the circumference of the central aperture that lie in a plane that does not intersect a central axis of the central aperture. Accordingly, the two opposing chamfered edges can be spaced apart by a distance that is less that the diameter of the central aperture, allowing the size of the body from which the locating member projects to be less than the diameter of the central aperture. This ensures that a portion of the central aperture can remain exposed, for the reasons described in detail above.

The needle support device is preferably formed from a plastics material and may be formed by injection moulding.

In a further aspect of the present invention, there is provided a kit for delivery of a radiopharmaceutical medicament, the kit comprising: a vial of radiopharmaceutical medicament, the vial comprising an opening sealed by a septum, a container containing the vial of radiopharmaceutical medicament and comprising an aperture at least partially aligned with a septum of the vial, and a needle support device in accordance with the first aspect of the present invention, wherein, when the needle support device is attached to the container, the body of the needle support device is in a fixed position relative to the container.

Preferably, the first guide axis of the needle support device is arranged, in use, substantially at right angles to a plane of the vial septum.

In some embodiments, wherein the needle support device comprises one or more locating members projecting from a proximal side of the body of the needle support device, the or each locating member is engaged with a circumference of the aperture of the container so as to located the needle support device on the container, in use. Preferably, the or each locating member comprises a tapered projection having an outside edge arranged to taper inwardly towards a central axis of the container aperture. With this arrangement, the outside edges of the tapered projection can act to guide the needle support device into a correct alignment with the container aperture. In some embodiments, wherein the needle support device comprises one or more locating members projecting from a proximal side of the body of the needle support device, the or each locating member comprises two opposing chamfered edges lying in a plane that does not intersect with a central axis of the container aperture.

In some embodiments, wherein the needle support device comprises a shield member as described above, the shield member is arranged such that at least a portion of the aperture remains exposed when the needle support device is attached to the container. With this arrangement, the central aperture of the container and the vial septum can still be accessed in the event that a manual intervention is required during the treatment. For example, in the event of an occlusion downstream of the vial, transfer of the radiopharmaceutical medicament by an infusion pump may be interrupted, requiring manual administration of the medicament to the patient by syringe. Ensuring that a portion of the central aperture of the container remains accessible when the needle support device is attached allows such contingency methods to be used, if necessary, without first having to remove the needle support device from the container. Ease of use is thereby improved. The exposed portion of the central aperture can be covered using an appropriate protective element, such as a tissue, whilst removing the needles or otherwise interacting with the needle support device.

The present invention is of particular benefit in a method of delivering a radiopharmaceutical medicament to a patient, the method comprising: fitting a needle support device in accordance with the first aspect of the invention to a container containing a vial of radiopharmaceutical medicament, said container comprising an aperture at least partially aligned with a septum of the vial; inserting a first needle into the first guide channel of the needle support device so as to pierce and extend through the vial septum, said first needle being arranged to extend to a bottom region of vial when a hub of the first needle is received within the needle hub support section of the first guide channel; inserting a second needle into the second guide channel of the needle support device so as to pierce and extend through the vial septum, said second needle being arrange to extend into a headspace of the vial such that a tip of the second needle is positioned above the level of liquid within the vial when a hub of the second needle is received within the needle hub support section of the second guide channel; connecting the first needle to an infusion line for the delivery of radiopharmaceutical medicament to a patient, said infusion line comprising an infusion pump arranged to draw the radiopharmaceutical medicament from the vial by suction through the first needle.

The second needle may be connected to a vent line, allowing air to be drawn into the vial to equalise the pressure within the vial following suction of the radiopharmaceutical medicament from the vial by the infusion pump. Alternatively or additionally, the second needle may be connected to a supply of vector fluid (such as saline solution) to allow vector fluid to be drawn into the vial in the same manner.

In some methods, a three-way valve may be provided to permit the second needle to be selectively connected to a vent line or a supply of vector fluid. Accordingly, the method may comprise delivery of a portion of the radiopharmaceutical medicament to the patient in an undiluted form (when the second needle is connected to a vent line) and delivery of a remaining portion of the radiopharmaceutical medicament in a diluted form (when the second needle is connected to a supply of vector fluid). In one preferred method, a half dose of the radiopharmaceutical medicament may be delivered in an undiluted form, with the remainder being delivered in a diluted form.

The use of a needle support device in accordance with the present invention in such ‘suction’ methods provides particular benefits over the known ‘positive pressure’ method described above.

Firstly, by fixing an orientation of the needles (in particular the first needle) along a predetermined guide axis, the tips of the needles can be prevented from coming into contact with the internal side walls of the vial due to unwanted pivoting of the needles and/or incorrect placement of the needles. This prevents occlusions resulting from the tips of the needles becoming wholly or partially blocked when in contact with the internal side walls of the container.

Secondly, the combination of the needle guide section and needle hub support section of each guide channel ensures that the position of a tip of each needle within the container can be easily set by simply inserting the needle into the respective guide channel until the needle hub is accommodated with the needle hub support section. This allows the user to easily ensure that the tip of the first needle is located at the bottom of the vial, below the level of the liquid, which in turn prevents air from unintentionally entrained in the fluid flow by suction from the infusion pump. The user need only select an appropriate size of needle.

Thirdly, distortion of the vial septum is prevented as described above. Accordingly, where saline solution is used as a vector fluid, the necessary suction pressure within the vial can be maintained to allow saline to be drawn into the vial at a controlled rate without overflowing.

Accordingly, the needle support device of the present invention enables the use of a direct suction method for the delivery of radiopharmaceuticals, with reduced risk of occlusion within the fluid line, air being entrained in the fluid line and overflow of the radiopharmaceutical medicament from the vial. The safe and reliable use of a direction suction method in turn overcomes many of the problems associated with known ‘positive pressure’ methods involving the use of a saline vector fluid. In particular, the flow rate of the radiopharmaceutical medicament (in either an undiluted or diluted form) can be more precisely and reliably controlled, reducing the complexity of the delivery method. The delivery of radiopharmaceutical therapies (such as radionuclide or radioligand therapy) is therefore less reliant on teams of specialist medical professionals, but instead can be carried out by a wider range of medical professionals in a larger number of locations. Access to such therapies for patients is thereby increased.

Non-limiting embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings in which:

Figure 1 is schematic illustration of a delivery system and method for the delivery of a radiopharmaceutical drug to a patient known in the art;

Figure 2 is a first perspective view of a needle support device in accordance with the present invention;

Figure 3 is a second perspective view of the needle support device of Figure 2;

Figure 4 is a perspective view of a kit for delivery of a radiopharmaceutical drug comprising the needle support device of Figures 2 and 3;

Figure 5A is a cross-sectional view of the kit of Figure 4, with first and second needles partially inserted into respective guide channels of the needle support device;

Figure 5B is an enlarged view of the circled region of Figure 5A; Figure 6 is a cross-sectional view of the kit of Figure 4, with first and second needles fully inserted into respective guide channels of the needle support device;

Figure 7 is a plan view of the kit of Figure 4;

Figure 8 is a cross-sectional view of a further embodiment of a needle support device in accordance with the present invention, and

Figure 9 is a schematic illustration of a further delivery system and method for the delivery of a radiopharmaceutical drug to a patient.

Figure 1 shows a known system and method for the delivery of radiopharmaceutical drugs to a patient. A vial 10 of radiopharmaceutical drug 12 is housed within a container 14 formed of a material or materials that block of the emission of radiation and therefore shield the user from the radiopharmaceutical drug 12. The container 14 comprises a central aperture 16, which prior to use is sealed with a cap (not shown). A first needle 18 is inserted through the central aperture and pierces a septum 20 of the vial 10 to extend below the level of radioactive fluid 12 within the vial 10. A second needle 22 extends through the central aperture of the container 14 and pierces the septum 20 of the vial 10. A tip 22a of the second needle 22 sits within the headspace above the fluid level within the container 14. The first needle 18 is typically longer than the second needle 22 in order to permit the above arrangement. The first needle 18 is connected to a first cannula 24 for delivery of the radiopharmaceutical drug 12 to a patient. The second needle 22 is connected to a second cannula 26 for the delivery of a saline solution into the vial 10.

In order to effect delivery of the radiopharmaceutical drug 12 to the patient, saline solution is pumped into the vial 10 via the second needle 22, creating a positive pressure within the vial 10 that drives the radiopharmaceutical drug 12 out of the vial 10 via the first needle 18, through the cannula 24, to be delivered to the patient intravenously. An infusion pump 28 is used to pump saline solution from a supply 30 (such as an IV bag) into the vial 10. The fluid level within vial 10 remains constant during the treatment, as the volume of saline solution input into the vial 10 equals the volume of radiopharmaceutical drug 12 output from the vial 10. Radiopharmaceutical drug 12 becomes diluted over the course of the treatment. Whilst this arrangement, under normal operation, provides safe delivery of the radiopharmaceutical drug, such methods have a number of draw backs as described above. With reference to Figures 2 and 3 there is shown a needle support device 32 in accordance with the present invention. The needle support device 32 comprises attachment means 34 for realisably attaching the needle support device 32 to a vial shield container 14 of the type described above. The needle support device 32 further comprises a body 36 arranged to locate on a top of a vial shield container 14, in use. In the illustrated embodiment, the body 36 comprises a platform extending over the top of the vial shield container 14. The body 36 has a proximal side 36a, which, in use, is located towards the vial shield container 14 and a distal side 36b located away from the vial shield container 14. In a normal orientation for use, wherein the needle support device 32 sits on top of a vial shield container 14, the proximal side 36a is defined by a lower surface of the body 36 and the distal side 36b is defined by an upper surface of the body 36.

The needle support device 32 comprises a first guide channel 38 extending through the body 36 for receiving a first needle, and a second guide channel 40 extending through the body 36 for receiving a second needle. As described in greater detail below, the first guide channel 38 defines a first guide axis A1 along which, in use, a shaft of the first needle extends on the proximal side 36a of the body 36. Similarly, the second guide channel 40 defines a second guide axis A2 along which, in use, a shaft of the second needle extends on the proximal side 36a of the body 36. Accordingly, the orientation of the first and second guide axes A1 , A2 define the orientation of the needle shafts when fully inserted within the needle support device 32. The second guide axis A2 is set at a predefined, non-parallel angle with respect to the first guide axis A1 . That is, the first guide axis A1 and the second guide axis A2 are not parallel with each other.

With reference to Figure 4, the needle support device 32 is shown attached to vial shield container 14 containing a vial 10 of radiopharmaceutical drug 12. In the illustrated embodiment, the attachment means 34 comprises a pair of resilient arms 42 provided on opposing lateral sides of the body 36. Each arm 42 comprises an engagement portion 44 extending proximally from the body 36. The engagement portions 44 engage with opposing sides of the container 14 so as to secure the needle support device on the container. In the illustrated embodiment, the engagement portions 44 each comprise a hooked portion 46 at a proximal end 44a of the engagement portion. The hooked portions 46 engage with a step 48 provided around the circumference of the substantially cylindrical container 14. It will be readily appreciated that the exact configuration of the attachment means 34 may vary depending on the configuration of the container 14 with which the needle support device 32 is intended for use.

Each of the resilient arms 42 is hinged to the body to permit the engagement portion 44 to flex away from the container 14 in order to allow the needle support device 32 to be attached to and released from the container 14. The resilient arms 42 are biased to a position in which the hooked portions 46 engage with the step 48. In a preferred embodiment, as illustrated, the needle support device 32 is moulded as a unitary component and each resilient arm 42 is joined to the body 36 by means of a living hinge 50. However, it will be appreciated that the resilient arms 42 could be formed as separate components attached to the body 36 by means of a hinge or other connector permitting the engagement portion 44 to flex away from the container 14.

Each resilient arm 42 further comprises a lever portion 52 extending distally from the body 36. The two lever portions 52 can thus be pressed inwardly towards a centre of the needle support device 32 so as to flex the engagement portions 44 away from the container 14 and permit release of the needle support device 32 from the container 14. Similarly, in order to install the needle support device 32 on the container, the lever portions 52 can be pressed inwardly to flex the engagement portions 44 away from each other, such that the spacing between the two engagement portions 44 (specifically, the spacing between the two hooked portions 46) is larger than a diameter of the container 14, thus permitting the needle support device 32 to be installed on the container 14.

Alternatively, the needle support device 32 may simply be aligned with a top of the container 14 and moved downwardly, such that engagement of the hooked portions 46 with a top of the container 14 causes the engagement portions 44 to flex away from each other. The needle support device 32 can then be moved downward until the hooked portions 36 reach the inward step 48 about the circumference of the container 14, permitting the resilient arms 42 to move inward under their bias to engage with the step 48, thus the securing the needle support device 32 on the container 14.

The above arrangement of the attachment means 34, including engagement portions 44 and lever portions 52, permits the user to attach and detach the needle support device 32 to/from the container 14, whilst holding the needle support device 14 at a position remote from the top surface of the container 14. Moreover, attachment and detachment of the needle support device 32 can be effected using only one hand in a relatively simple operation. This reduces the risk of the user receiving a ‘finger dose’ of the radiopharmaceutical drug 12.

When the needle support device 32 is secured/attached to the container 14 by the attachment means 34 (i.e. when the resilient arms 42 and engagement portions 44 thereof secure the device 32 onto the container 14), the body 36 of the needle support device 32 is in a fixed position relative to the attachment means 34. Thus, when the device 32 is secured to the container 14 by the attachment means 34, the first and second guide channels 38, 40 remain in a fixed position relative to the attachment means 34 and, therefore, relative to the container 14. In particular, the guide channels 38, 40 are not movable in an axial (upward/downward) direction when the device 32 is attached to the container 14, ensuring that the first and second needles remain in the desired position for the duration of the procedure.

Figure 5A shows the needle support device 32 fitted to container 14 in cross section, wherein first and second needles 18, 22 are partially received within the first and second guide channels 38, 40, respectively. Figure 5B shows enlarged region of the needle support device 32.

Each of the first guide channel 38 and second guide channel 40 comprises a proximal opening 38a, 40a on the proximal side 36a of the body 36, and a distal opening 38b, 40b on the distal side 36b of the body 36.

Each of the first and second guide channels 38, 40 comprises a needle guide section 54 terminating at the proximal opening 38a, 40a and being arranged, in use, to accommodate a shaft 56 of a needle 24 received within the respective guide channel 38, 40 in a close-fitting relationship. The needle guide section 54 is arranged to have a diameter slightly larger than the needle shaft 56, so as to provide lateral support to the needle shaft 56 and fix an orientation of the needle shaft 56 along the first or second guide axis A1 , A2. That is, a central axis of the needle guide section 54 defines the first or second guide axis A1 , A2, along which the shaft 56 of the needle 24 extends on the proximal side 36a of the body 36. This arrangement prevents bending of the needle shaft 56, which may result in an angle of the needle 24 received within the needle guide channel 28, 40 differing from an angle at which the needle shaft 56 pierces the septum 20 of vial 10, which could place a bending stress on the needle 24 and potentially deform the vial septum 20.

Figure 6 shows the needle support device 32 fitted to container 14 in cross section, wherein first and second needles 18, 22 are fully received within the first and second guide channels 38, 40, respectively.

Each of the first and second guide channels 38, 40 further comprises a needle hub support section 58 terminating at the distal opening 38b, 40b and being in communication with the needle guide section 54. The needle hub support section 58 has a diameter larger than a diameter of the needle guide section 54and is arranged to accommodate at least a portion of a hub 60 of the needle 24 in a close-fitting relationship.

The needle hub support section 58 is sized and shaped so as to provide lateral support to the needle hub 60, so as to maintain an orientation of the needle 24 along the first or second guide axis A1 , A2. That is to say, lateral movement of the needle hub 60 in a direction having a component orthogonal to the first or second guide axis A1 , A2 is substantially prevented by the needle hub support section 58. Accordingly, bending of the needle shaft 56 due to the weight of a connected IV line or to being accidently knocked by a user, for example, is substantially prevented. This prevents any such loads from being transferred to the vial septum 20 via the shaft 56 of the needle 18, which could potentially distort the vial septum 20 and permit leakage of the radiopharmaceutical drug through the vial septum 20, thus potentially exposing the medical professional and/or patient to the radioactive substance. Moreover, distortion of the vial septum 20 can result in an imperfect seal being formed between the needle shaft 56 and the vial septum 20, causing a loss of pressure within the vial 10, allowing the fluid level within the vial 10 to rise (e.g. where saline solution is used as a vector fluid) and, in turn, possible overflow and leakage of the radiopharmaceutical drug 12.

The needle hub support section 58 of each of the first and second guide channels 38, 40 is tapered towards the needle guide section 54. That is, a diameter of the needle hub support section 58 may gradually decrease towards the needle guide section 54. In the embodiment illustrated in Figures 5 and 6, the needle hub support section 58 has a substantially cylindrical portion 58a and a tapered portion 58b, wherein the angle of taper of the needle hub support section 58 is greater in the tapered portion 58b than in the substantially cylindrical portion 58a. It will be appreciated that the substantially cylindrical portion 58a may have a shallow angle of taper, as shown in Figures 5 and 6. However, the substantially cylindrical portion may have a constant diameter along the respective guide axis A1 , A2.

The provision of a tapered portion 58b assists with initially locating the tip 18a, 22a of a needle 18, 20 within the guide channel 38, 40 to direct the needle tip 18a, 22a towards the relatively narrow needle guide section 54. As can be seen in Figure 5, the angle of taper of the tapered portion 58b becomes shallower in the vicinity of the needle guide section 54 so as to provide a smooth transition between the needle hub support section 58 and the needle guide section 54.

For safety reasons, the central aperture 16 of the container 14 is generally made with relatively small dimensions. As shown in Figures 5 and 6, the central aperture 16 comprises an upper opening 16a and a lower opening 16b, wherein the upper opening 16a is larger than the lower opening 16b and wherein the aperture 16 is tapered between the upper and lower openings 16a, 16b.

By ensuring the first guide axis A1 and the second guide axis A2 are non-parallel, it is possible to orient the needles received within the first and second guide channels 38, 40, such that both needles can extend through the relatively small lower opening 16b of the central aperture 16 and thus pierce the vial septum 20, whilst still ensuring that both needles are fully supported within respective needle hub support sections 58 of the first and second guide channels 38, 40. Accordingly, with the arrangement of the present invention, both the needles can be fully supported, even where the size of the central aperture 16 in the container 14 is minimised.

Referring to Figures 3, 5 and 6 in particular, the body 36 comprises a substantially planar base 62, which is arranged to engage with a top of a container 14, in use (see Figure 4). Accordingly, the base 62 of the body 36 is in a plane substantially parallel with a plane of the top of the container 14 and a plane of the vial septum 20 within the container 14. The first guide channel 38 is oriented such that the first guide axis A1 is substantially perpendicular to the plane of the base 62 of the body 36 and, consequently, substantially perpendicular to a plane of the top of the container 14 and of the vial septum 20.

Accordingly, the first needle 18, which may be a needle through which radiopharmaceutical drug is extracted from the vial 10, pierces the vial septum 20 at right angles to the vial septum 20, thus minimising the risk of distortion of the vial septum 20 at the location at which the shaft 56 of the first needle 18 passes through the vial septum 20. However, it will be appreciated that the first guide channel 38 may be arranged such that the first needle 18 pierces the vial septum 20 at any desired angle.

The second guide axis A2 is set at an angle a that is in the range 1 to 45 degrees with respect to the first guide axis. In particular preferred embodiments, the second guide axis is set at an angle in the range 5 to 20 degrees with respect to the first guide axis. Such an angle permits the needles to both be supported within a respective needle hub support section whilst still being able to extend through a relatively small central aperture in the container 14.

With reference to Figures 2 to 4 and 7, in particular, the needle support device 32 further comprises a shield member 64 adjoining the body 14. As shown most clearly in Figure 4, the shield member 64 is arranged, in use, to cover a portion of the central aperture 16 of the container 14. The shield member 64 provides a barrier to restrict exposure of the user to the radiopharmaceutical drug 12 in the event that an amount of the radiopharmaceutical drug 12 undesirably leaks through the top of the vial septum 20 during use. The safety for the user is thereby improved.

However, the shield member 64 of the illustrated embodiment is also arranged such that at least a portion of the central aperture 16 of the container 14 remains exposed when the needle support device 32 is attached to the container 14. This allows direct access to the vial septum 20 via the central aperture 16 whilst the needle support device 32 is attached to the container 14, to allow a contingency method for extraction of the radiopharmaceutical drug 12 to be used if necessary, for example by manual extraction using a syringe. Accordingly, the needle support device 32 improves the safety of the use of the container 14, whilst also ensuring full access to the vial 10 held within the container 14 in the event of a failure in the primary method of administration.

In the illustrated embodiment, the body 36 comprises an elongate member arranged to extend across the top of the container 14 and the shield member 64 comprises a lateral projection located on one side of the body 36. The lateral projection in this instance is substantially semi-circular, such that it is adapted for use with a container having a substantially circular central aperture 16. It will be appreciated, however, that the shape of the lateral projection may be varied according to the shape of the central aperture 16 in the container 14. Importantly, the needle support device 32 does not comprise a projection on the side of the body 36 opposing the shield member 64, so as to ensure a portion of the central aperture 16 remains uncovered, in use. The shield member covers an area on one side of the body 36, whilst a corresponding area on the other side of the body 36 is uncovered. As discussed above, this provides shielding from positive pressure in the vial 10, which may cause spray-back of the radiopharmaceutical drug 12 as the needles are removed, for example. A tissue or other protective article can be used to cover the exposed portion of the central aperture 16 when removing the needles.

The arrangement of the shield member 64 is further shown in Figure 7, which is a plan view of the needle support device 32 when fitted to container 14. As can be seen, the shield member 64 and the body 36, in combination, define a substantially circular cover 66 arranged to extend over the circular aperture 16 of the container 14. A segment of the substantially circular cover 66 is absent such that a portion 17 of the central aperture 16 remains exposed when the needle support device 32 is fitted to the container 14.

Referring again to Figures 2 and 3, the needle support device 32 further comprises a pair of locating members 68 projecting from the proximal side 36a of the body 36. The locating members 68 are arranged to engage with a circumference of the central aperture 16 of the container 14 so as to locate the needle support device 32 on the container 14.

Each of the locating members 68 comprises a tapered projection 70 having an outside edge 70a that tapers inwardly towards a centre of the needle support device 32. As can be seen in Figure 5, the tapered outside edges 70a of the tapered projection 70 bear against an inner circumference of the upper opening 16a of the central aperture 16 to guide the needle support device 32 into the correct location on the container 14. Additionally, the tapered projection 70 allows the needle support device 32 to be fitted to a range of containers with central apertures of varying diameters. Ideally, each tapered projection 70 has an outside edge 70a that is arranged to taper inwardly towards a central axis of the central aperture 16 of the container 14, in use. This ensures that the tapered projections 70 guide the needle support device into a centred position at the top of the container 14. Each locating member 68 further comprises a projection 72 having a pair of opposing chamfered edges 72a, 72b. The opposing chamfered edges 72a, 72b permit the quick and easy location of the needle support device on the container 14 and ensure that the needle support device is correctly aligned with the central aperture 16 of the container.

In the illustrated embodiment, the two opposing chamfered edges 72a, 72b of the projection 72 lie in a plane that does not intersect a central axis of the needle support device 32. Accordingly, the opposing chamfered edges 72a, 72b of each projection 72 engage with the internal circumference of the upper opening 16a of the central aperture 16 at points that lie a plane that does not intersect with a central axis of the central aperture 16 of the container 14. This allows the two chamfered edges 72a, 72b of the projection 72 to be spaced apart by a distance that is less than the diameter upper opening 16a of the central aperture 16, thus allowing the size of the body 36 to be less than the diameter of the central aperture 16. This in turn allows a portion of the central aperture 16 to remain exposed, which is desirable for the reasons outlined above.

The two locating members 68 are located on opposing sides of the first and second guide channels 38, 40, thus allowing the locating members 68 to locate the first and second guide channels 38, 40 within the central aperture 16 on the container 14. In the illustrated embodiment, the tapered projection 70 and the chamfered projection 72 adjoin one another and thus form a single projection from the proximal side of the body 36. However, it will be appreciated that the tapered projection 70 and chamfered projection 72 may be provided separately on the proximal side of the body 36. Similarly, a single chamfered projection 72 having opposing chamfered edges 72a, 72b is shown, however it will be readily appreciated that the two opposing chamfered edges could be provided on individually projections, whilst still being arranged in the advantageous manner described above.

With reference to Figure 8, there is shown a further embodiment of a needle support device 132 in accordance with the present invention. The needle support device 132 comprises a body 136 arranged to locate on a top of a vial shield container 114. Features in common with the embodiment of Figures 1 to 7 are indicated with corresponding numerals and are not further described. The needle support device 132 comprises attachment means 134 in the form of resilient lever portions 152 extending distally from the body 136 and connected to the body 136 by living hinges 150. The lever portions 152 are biased outwardly, away from a central portion of the body 136 in which first and second guide channels 138, 140 are provided. In use, the lever portions 152 engage with opposing sides of a central aperture 116 so as to locate the needle support device 132 within the central aperture 116, and thus locate the needle support device 132 on a top of the container 114.

It will be appreciated that, in the context of the present invention, location of the needle support device on the top of a container is not limited to an arrangement in which the body sits on a top surface of the container, as for the embodiment of Figures 1 to 7, but also includes other arrangements in which means are provided for securing the body in proximity to a top of the container (for example, to a lid of the container) in a fixed position, such as the ‘plug’-type arrangement of Figure 8. Other arrangements will be conceivable to the skilled person.

The resilient lever portions 152 can be moved inward against their bias in order to permit the needle support device 132 to be inserted into and removed from the central aperture 116. This can be achieved in a single-handed action. Furthermore, the position at which the user interacts with the needle support device 132 is remote from the body 136, and concurrently remote from the top of the container 114, improving safety to the user as described above.

Figure 9 illustrates a further delivery system and delivery method for the delivery of radiopharmaceutical medicament to a patient. The system comprises a vial 10 of radiopharmaceutical drug 12 housed within a container 14 formed of a material or materials that block of the emission of radiation and therefore shield the user from the radiopharmaceutical drug 12. A needle support device 32 is attached to the container 14 to support first and second needles 18, 22, which extend through a central aperture 16 of the container 14 and through a septum 20 of the vial 10. The first needle 18 extends below the level of fluid within the vial 10. A first cannula 24 is connected to the first needle 18 for delivery of radiopharmaceutical drug 12 to the patient. A second cannula 25 is connected to the second needle 26 for the delivery of saline solution into the vial 10 from a supply 30 (such as an IV bag), which is provided in an elevated location relative to the vial 10 to permit saline to be fed into the vial 10 by gravity. An infusion pump 28 is located downstream of the vial 10, permitting direct infusion of the radiopharmaceutical drug 12 to the patient. Accordingly, the method involves suction of the radiopharmaceutical drug 12 from the vial 10, rather than relying on the build-up of positive pressure within the vial 10, as for the system and method illustrated in Figure 1 . This prevents the level of liquid within the vial 10 from increasing, even in the event of an occlusion somewhere in the fluid circuit. Accordingly, the likelihood of radiopharmaceutical leaking from the vial 10 is greatly reduced.

Additionally, this arrangement allows more effective metering of the flow of radiopharmaceutical drug 12, which can be infused without further dilution with saline, achieving more precise control of the drug delivery profile. Furthermore, occlusions can be detected by the infusion pump 28 more effectively, since there are no other components in the fluid circuit between the occlusion sensor in the infusion pump 28 and the patient.

A three-way tap 74 is provided in connection with the first cannula 24, allowing the delivery line to be primed prior to treatment. A flow switch 76 is provided in connection with the second cannula 25, permitting the second cannula 25 to be selectively connected to either a vent 78 or to the saline supply 30. Accordingly, radiopharmaceutical drug 12 can be supplied either in an undiluted form, where the flow switch 76 connects to the vent 78, or in a diluted form, where the flow switch 76 connects to the saline supply 30.

It will be appreciated that saline solution may be fed into the vial 10 under the action of gravity, as described above, or by the reduced pressure created within the vial 10 as a result of suction from the infusion pump 28, or by any other appropriate means.

In a preferred delivery method, a half dose of the radiopharmaceutical drug 12 is delivered in an undiluted form, with the remainder being delivered in a diluted form. In this regard, it is to be noted that the vial 10 is arranged to contain one complete dose of the radiopharmaceutical drug 12. Such a method provides improved control of the delivery of radiopharmaceutical drug compared to other known methods.

The use of the needle support device 32 of the present invention has particular benefits for the delivery method illustrated in Figure 9, as described in detail above. The invention has been described above with reference to specific embodiments, given by way of example only. It will be appreciated that different arrangements of the system are possible, which fall within the scope of the appended claims.

Claims

1 . A needle support device for use with a container for a vial of radiopharmaceutical medicament, the needle support device comprising: a body arranged to locate on a top of a container, in use, and having a proximal side located towards a container to which the device is attached, in use, and a distal side located away from a container to which the device is attached, in use, a first guide channel extending through the body for receiving a first needle, the first guide channel defining a first guide axis for a needle shaft, and a second guide channel extending through the body for receiving a second needle, the second guide channel defining a second guide axis for a needle shaft, wherein each of the first and second guide channels comprises: a proximal opening at the proximal side of the body and a distal opening at the distal side of the body, a needle guide section leading to the proximal opening and being arranged, in use, to accommodate a shaft of a needle received within the first or second guide channel, and a needle hub support section having a diameter larger than a diameter of the needle guide section, the needle hub support section being arranged to accommodate a hub of a needle received within the guide channel.

2. A needle support device according to claim 1 , further comprising attachment means for releasably attaching the needle support device to a container so as to locate the body on a top of said container, wherein the body is in a fixed position relative to the attachment means.

3. A needle support device according to claim 2, wherein the attachment means comprises first and second resilient arms provided on opposing lateral sides of the body and extending proximally from the body to engage with opposing sides of a container, in use.

4. A needle support device according to claim 3, wherein each of the first and second resilient arms is joined to the body by a living hinge.

5. A needle support device according to claim 3 or 4, wherein each of the first and second resilient arms comprises a hooked portion at a proximal end thereof.

6. A needle support device according to any one of claims 2 to 5, wherein the attachment means comprises a pair of opposing lever portions extending distally from the body.

7. A needle support device according to any preceding claim, wherein the needle hub support section of the first and/or second guide channel tapers towards the needle guide section.

8. A need support device according to claim 7, wherein the angle of taper of the needle hub support section increases towards the needle guide section.

9. A needle support device according to any preceding claim, wherein the second guide axis is set at a predefined, non-parallel angle with respect to the first guide axis.

10. A needle support device according to claim 9, wherein the second guide axis is set at an angle in the range 1 to 45 degrees with respect to the first guide axis.

11. A needle support device according to any preceding claim, wherein the body comprises a substantially planar base and wherein the first guide axis is substantially perpendicular to a plane of the base of the body.

12. A needle support device according to any preceding claim, further comprising a shield member adjoining the body, the shield member being arranged, in use, to cover at least a portion of an aperture located in a top of a container to which the needle support device is attached.

13. A needle support device according to claim 12, wherein the shield member comprises a lateral projection located on one side of the body.

14. A needle support device according to claim 13, wherein the lateral projection is substantially semi-circular.

15. A needle support device according to claim 14 or 15, wherein the body does not comprise a projection on a side of the body opposing the side on which the shield member is located.

16. A needle support device according to any preceding claim, wherein the body comprises one or more locating members projecting from a proximal side of the body.

17. A needle support device according to claim 16, wherein the or each locating member comprises a tapered projection having an outside edge arranged to taper inwardly towards a centre of the needle support device.

18. A needle support device according to claim 16 or 17, wherein the or each locating member comprises a projection having a pair of opposing chamfered edges.

19. A needle support device according to claim 18, wherein the two opposing chamfered edges lie in a plane that does not intersect a central axis of the needle support device.

20. A needle support device according to any one of claims 16 to 19, comprising two locating members arranged on opposing sides of the first and second guide channels.

21 . A kit for use in the delivery of a radiopharmaceutical medicament, the kit comprising: a vial of radiopharmaceutical medicament, the vial comprising an opening sealed by a septum, a container containing the vial of radiopharmaceutical medicament and comprising an aperture at least partially aligned with a septum of the vial, and a needle support device in accordance with any one of claims 1 to 20, wherein, when the needle support device is attached to the container, the body of the needle support device is in a fixed position relative to the container.

22. A kit according to claim 21 , wherein in use the first guide axis is arranged, in use, substantially at right angles to a plane of the vial septum.

23. A kit according to claim 21 or 22, when dependent on any one of claims 16 to 20, wherein the or each locating member is engaged with a circumference of the aperture of the container so as to locate the needle support device on the container, in use.

24. A kit according to claim 23, when dependent on claim 17, wherein the or each tapered projection has an outside edge arranged to taper inwardly towards a central axis of the container aperture.

25. A kit according to claim 23 or 24, when dependent on claim 18, wherein in use the two opposing chamfered edges lie in a plane that does not intersect with a central axis of the container aperture.

26. A kit according to any one of claims 21 to 25, when dependent on any one of claims 12 to 15, wherein, when the needle support device is attached to the container, the shield member covers at least a portion of an aperture located in a top of a container to which the needle support device is attached.

27. A kit according to claim 26, wherein at least a portion of the aperture remains exposed when the needle support device is attached to the container.