WO2025238134A1

WO2025238134A1 - Holder for a syringe or vial containing radiopharmaceuticals

Info

Publication number: WO2025238134A1
Application number: PCT/EP2025/063346
Authority: WO
Inventors: Helmut Aicher; Maximilian FUNCK
Original assignee: Plastformance GmbH
Current assignee: Plastformance GmbH
Priority date: 2024-05-15
Filing date: 2025-05-15
Publication date: 2025-11-20
Anticipated expiration: 2026-11-15

Abstract

The present invention generally relates to concepts for handling liquid radiopharmaceuticals or other radioactive substances. More particularly, the invention relates to holders (300) comprising a sleeve (310) having an inner space (320) for encasing, for example, syringes (200) or vials while being filled with liquid radiopharmaceuticals or other radioactive substances, or during administration of liquid radiopharmaceuticals to a patient, or during transport. The invention also relates to syringes (200) with a backside radiation shielding.

Description

HOLDER FOR A SYRINGE OR VIAL CONTAINING RADIOPHARMACEUTICALS

FIELD OF THE INVENTION

The present invention generally relates to handling radioactive substances, in particular radiopharmaceuticals. More particularly, the invention relates to processing holders for encasing a syringe barrel or vial while being filled with liquid radiopharmaceuticals, or during administration of liquid radiopharmaceuticals to a patient, and transportation holders for encasing syringes or vials filled with liquid radiopharmaceuticals or other radioactive substances during transport. The invention also relates to syringes with a backside radiation shielding.

BACKGROUND OF THE INVENTION

Injectable liquid radiopharmaceuticals are known for various medicinal purposes, such as oncological treatment. The production and application side processing and the transportation of syringes or vials comprising liquid radiopharmaceuticals or other radioactive substances is challenging in terms of protection from radiation. A large number of transportation and processing holders that shield from radiation have hence been proposed.

For example, processing and transportation holders for syringes comprising radiopharmaceuticals are disclosed in US 6,828,577 B2, US 2008/091164 A1 and EP 3 871 710 A1. A radiation protection device to be fitted onto a syringe comprising radiopharmaceuticals during injecting is disclosed in US 2013/317277 A1. An overall concept for handling and transport of radiopharmaceuticals, which includes using processing and transportation holders, is disclosed in US 2007/208308 A1.

All known transportation and processing holders include radiation shielding comprising heavy elements, such as lead or tungsten. These materials are difficult to process. It is hence difficult to produce shapes that optimize radiation protection against material use. This often makes holders unnecessarily bulky, heavy and expensive.

SUMMARY OF THE INVENTION

The present invention aims to address limitations of existing processing and transportation holders for syringes or vials comprising radiopharmaceuticals or other radioactive substances by providing a holder having molded radiation shields from heavy element filled polymer compositions with shapes that optimize radiation protection against material use.

Specifically, in a first aspect, the invention proposes a processing or transportation holder for a syringe or vial containing a radiopharmaceutical or other radioactive substance, the holder comprising: a sleeve having a circumferential wall defining a generally cylindrical inner space, and having an open top end for top-down insertion of a barrel of the syringe or a vial into the inner space. Preferably, the sleeve has a closed bottom. According to the invention, the sleeve is a molded part made from a polymer material filled with a particulate filler material comprising a heavy element. Further, according to the invention, at least part of the outer surface of the sleeve forms a rounded contour having a bulge in a middle portion of the circumferential wall, while the corresponding inner surfaces of the sleeve have flatter wall segments and relatively sharper transitions, thereby resulting in a non-uniform wall thickness of the sleeve.

In embodiments, the generally cylindrical inner space of the sleeve may comprise a main section having a first diameter and a bottom-side section having a relatively smaller diameter, and the outer surface of the sleeve may reflect the stepped configuration while maintaining a generally rounded overall shape.

In embodiments, the processing or transportation holder further comprises a lid removably attached to the open top end of the sleeve for sealing the inner space the lid. The lid can also be a molded part made from a polymer material filled with a particulate filler material comprising a heavy element, and can be the same polymer material comprising the same filler material. Also on the lid, the outer surface can form a rounded contour, while the inner surface has flatter wall segments and relatively sharper transitions, resulting in a non-uniform wall thickness.

In embodiments, a circumferential rim can be formed on an edge of the sleeve that defines the open top end, or on a complementary lower surface of the lid, the rim axially protruding upwards from the sleeve or downwards from the lid. The lid or sleeve, correspondingly, can comprise a complementary grooved contour configured to receive the axially protruding rim of the sleeve or lid, preferably in a form-fitting manner. Additionally or alternatively, the lid can comprise a circumferential downward-extending lip configured to radially enclose an upper peripheral portion of the sleeve, preferably in a form-fitting manner. The lid may generally have a flat shape, which can be preferred for holders configured to receive a syringe barrel without plunger, or a vial, for example during filling. Alternatively, the lid may have an axially elongated shape and define a generally cylindrical inner space, in extension to the generally cylindrical inner space of the sleeve, for receiving a plunger of the syringe. The lids can be exchanged to change between processing and transportation configurations of the holder.

The molded sleeve and/or cap is made by injection molding, where a viscous filled polymer composition is filled into a corresponding mold and hardened before deforming. The ability to mold parts in a standard polymer injection molding process allows for a low-cost and straightforward production of parts having complex geometries as proposed by the invention for the sleeve and lid to optimize radiation protection against material use. This is in contrast to some metal parts made from metal injection molding (MIM) or computerized numerical control (CNC) machining, sintered parts (that may be formed from a molded filled polymer composition but have been depleted of polymer material during firing), or metal coated parts as frequently used in radiation shielding. A key idea of the invention is the variable wall thickness and rounded shape, to have shielding material as thick as necessary but as thin as possible at each position of the sleeve and lid, inter alia at each position of the circumferential wall and bottom of the sleeve, to effectively shield against radiation emitted from a radiopharmaceutical or other radioactive substance contained in a syringe or vial that is held in the holder. Following this condition, the rounded outer contour and the variable wall thickness along the length axis of the holder, specifically the sleeve and the lid, results from a cylindrical shape of the radioactive substance (syringe barrels and vials are typically cylindrical, and if the radioactive substance is liquid, it assumes this shape) and from additional empty spaces in the inner space, e.g. for receiving the plunger of a syringe, from where no radiation is emitted.

The molded parts may be single shot injection molded parts, or may be multiple shot injection molded parts or two or more form-fittingly assembled injection molded parts. While monolithic single shot injection molded parts may be preferred in embodiments, in other embodiments, for example where a wall thickness exceeds a certain value, multiple shots or shells may be necessary due to procedural constraints.

The particulate filler material is preferably a powder material. The filler material can comprise the heavy element in the form of a pure metal, a metallic alloy of the heavy element, or a ceramic material including the heavy element. The heavy element is defined as an element of atomic number (Z) of 57 or greater, preferably 72 or greater, a density of 7 g/ccm or greater, preferably 10 g/ccm or greater, or both. Preferred examples comprise tungsten or bismuth, as metals, metal alloys, carbides or oxides. Tungsten materials such as metallic tungsten or tungsten carbide can be particularly preferred. Heavy metal elements are suitable for shielding against y-radiation. In embodiments, the filler material can be free of lead, which has good y-radiation shielding properties but is poisonous and should be avoided. Further, in embodiments, the filler material is free of ferromagnetic compounds, as the processing or transportation holder may be used in proximity of MRT or similar medical devices.

In embodiments, the processing or transportation holder of the invention can further comprise housing structures enclosing the sleeve and the lid. Appropriate housing structures can comprise shells and liners formed from polymer materials, or rubbery impact protection elements.

In embodiments, the processing or transportation holder of the invention can comprise one or more additional shells in the inner space of the sleeve. For example, an inner shell can be a molded shell made from a polymer material filled with a different particulate filler material comprising relatively lighter elements and having a lower density compared to the filler material of the sleeve, or a non-filled polymer material. In the case of more than one shell, the density of the material can increase from the inner shell to the next shell to the sleeve. For example, the inner shell can be made from a non-filled polymer material and a middle shell positioned between the inner shell and the sleeve inner wall can be made from a polymer material filled with a particulate filler material comprising relatively lighter elements and having a lower density compared to the filler material of the sleeve.

Suitable polymer base materials for use in the filled polymer materials of the sleeve and/or lid can be, for example, as described in WO 2017/028939 A1 and WO 2018/141587 A1. The polymer base material(s) may be polar polymers, i.e. a polymer having polar functional groups, like esters or amides, included in their backbone or in side chains. An example are polyamides, which have an amide group included in their backbone. PA6 or PA12 are examples. Further examples are aliphatic polyesters and y-radiation resistant aromatic liquid crystalline polymers (LCPs).

The content of the filler material in the filled polymer material of the sleeve and/or lied can be 40 vol% or greater, preferably 50 vol% or greater, more preferably 55 vol% or greater, based on the total volume of the filled polymer material. The vol% of the filler material relative to the total volume of the filled polymer material can be converted to wt% over the densities (g/ccm) of the polymer material and the material forming for the particulate filler material. For example, when a thermoplastic polyamide material having a density of 1.15 g/ccm and a ceramic filler material having a density of 15,6 g/ccm (tungsten carbide) are used, a volume content of 30 vol% particulate filler material would correspond to a weight content of approx. 85 wt%. When describing the present invention, vol% are often used instead of wt% because the vol% fractions are independent of the kind of filler material and more directly informative on the volume fraction of the filled polymer material that is occupied by the filler material, which is the decisive property for the ability of the filled polymer material to shield against radiation. In preferred cases, the ability of the filled polymer material to shield against radiation shall approximate the respective ability of the isolated filler. Assuming standard Gaussian distributions and granular particles, the theoretical maximum is approx. 64 vol%, which corresponds to the average maximum of monomodal distributions. A bimodal maximum of approx. 87 vol% is possible.

A quantity that is proportional to the ability to shield against y-radiation is the density of the filled polymer material of the sleeve and/or lid. It is preferably greater 10 g/ccm, more preferably greater 12 g/ccm, and yet more preferably greater 14 g/ccm.

In the case of one or more additional shells in the inner space of the sleeve, when such shells are made of a filled polymer material, particulate filler materials can comprise elements of atomic number (Z) of 56 or smaller, preferably 30 or smaller, a density of 6 g/ccm or less, preferably 4 g/ccm or less, or both. Examples comprise silica, magnesium oxide, magnesium hydroxide or aluminum oxide. Metal filler materials such as, for example, aluminum powder, can be an alternative. Such light filler materials can eliminate p-radiation, while the heavy elements of the sleeve shield against y-radiation and secondary radiation resulting from the absorption of p-radiation. This may allow further minimizing the use of expensive and weighty heavy elements.

In embodiments, the sleeve can comprise a window made from a transparent and radiation shielding material. The material may be lead glass. A window allows a practitioner to see the inside of the syringe or vial from the outside while the syringe is received in the syringe holder. The window may be in a stripe form and extend over at least part of the sleeve in a length direction thereof. In embodiments where the bottom of the sleeve is not closed, the inner space may comprise a stop contour limiting a top-down movement of the barrel.

In embodiments, the holder may comprise a holding mechanism to releasably secure the syringe barrel against reverse movement towards the open top end. In an example, the holding mechanism can be an oval ring formed from an elastically deformable material. The ring can have a number of inwardly protruding teeth, or one or more cutting edges. The teeth or cutting edges can be arranged at the less curved sections of the oval ring where the ring intersects with the minor axis. The dimension and bias of the oval ring, and the configuration of the teeth or cutting edges, can be such that a syringe can be inserted into the inner space in a longitudinal movement from back to front without much resistance, but that a back movement is effectively avoided by the teeth or cutting edges that superficially penetrate into the syringe barrel. The circle can be slightly twisted. The inner circumferential surface of the ring can slightly taper in insertion direction, i.e. from back to front. For release, the ring can comprise or be in contact with one or two buttons arranged at the outside of the more curved sections of the oval ring where the ring intersects with the major axis. The button(s) can be accessible from the outside of the holder. The oval ring can be compressed to a more circular shape by pushing the button(s), and/or for reduced taper, so that the teeth or cutting edges retract from the syringe and the syringe can slide out from the inner space in a longitudinal front to back movement. This facilitates a quick release function, which helps reducing a radiation exposure of medical personnel when disposing of the syringe after application.

In embodiments where the bottom of the sleeve is not closed, a bottom end opening of the inner space can be covered by a cap. The cap can be a molded part made from a filled polymer material, as described for the sleeve and lid.

In context second aspect, the invention proposes a syringe for receiving a radiopharmaceutical, the syringe comprising a barrel and a plunger having a plunger stamp, wherein the plunger stamp comprises a barrier in the form of a molded part made from a polymer base material filled with a particulate filler material comprising a heavy element. The barrier is preferably circular shaped and extends over the entire area of the plunger stamp. In an embodiment, the plunger can be a monolithic part made from 2K injection molding and the barrier is formed by one of the components of the monolithic 2K injection molded part. Alternatively, the barrier can be attached to the plunger stamp as a separate part, which can, in one embodiment, be a clip-on part. Further alternatively, the plunger stamp or entire plunger can be formed from a filled polymer material and constitute the barrier. Having only part of the plunger or a separate part formed from a filled polymer material can be of benefit in terms of cost and weight of the syringe.

A syringe that comprises radiation shielding properties on its back side can be preferable because radiation protection is maintained also when the syringe is in use.

The invention also relates to a filled processing or transportation holder that comprises a processing or transportation holder according to the first aspect and a syringe or a vial, wherein the syringe or the vial contains a radiopharmaceutical or other radioactive substance and is received in the inner space of the sleeve.

The syringe or vial may be charged with a liquid composition comprising radioactive substances for nuclear medicine applications.

The holder may enclose the syringe or vial for transportation only or may enclose a syringe for both transportation and when in use. When in use, a user may remove the lid from the back of the holder to expose the plunger of the syringe. The user may then remove the cap and connect a needle to the tip I needle hub. She may thereby hold the syringe holder such that the front of the syringe faces away from her, and wear protective hand wear or use tools, such that she is not at all exposed to radiation emitted from the front of the syringe. She may then apply the syringe to the patient while the syringe is still contained in the syringe holder. She may then reattach the cap and dispose the syringe holder as a whole, or trigger the release and dispose of the used syringe in radioactive waste, separate from the syringe holder.

Further details and advantages of the invention are described in the following with reference to different examples.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1-5 show a perspective view (Fig. 1), top view (Fig. 2), a side view (Fig. 3), a bottom view (Fig. 4) and a longitudinal section (Fig. 5) of a sleeve of an embodiment of a holder according to the invention, suitable for holding a syringe. Fig. 6-10 show a perspective view (Fig. 6), top view (Fig. 7), a side view (Fig. 8), a bottom view (Fig. 9) and a longitudinal section (Fig. 10) of a lid suitable to seal the inner space of the sleeve shown in Fig. 1-5.

Fig. 11-13 show a longitudinal section (Fig. 11), a perspective longitudinal section (Fig. 12) and a longitudinal section with added schematic radiation paths (Fig. 13) through a holder formed from combining the sleeve as shown in Fig. 1-5 and the lid as shown in Fig. 6-10, with a syringe received therein.

Fig. 14-18 show a perspective view (Fig. 14), top view (Fig. 15), a side view (Fig. 16), a bottom view (Fig. 17) and a longitudinal section (Fig. 18) of a sleeve of an embodiment of a holder according to the invention, suitable for holding a vial.

Fig. 19-23 show a perspective view (Fig. 19), top view (Fig. 20), a side view (Fig. 21), a bottom view (Fig. 22) and a longitudinal section (Fig. 23) of a lid suitable to seal the inner space of the sleeve shown in Fig. 14-18.

Fig. 24-26 show a longitudinal section (Fig. 24), a perspective longitudinal section (Fig. 25) and a longitudinal section with added schematic radiation paths (Fig. 26) through a holder formed from combining the sleeve as shown in Fig. 14-18 and the lid as shown in Fig. 19-23, with a syringe received therein.

Fig. 27-31 show a perspective view (Fig. 27), a side view (Fig. 28), a top view (Fig. 29) and sectional views (Fig. 30-31) of an embodiment of a holder according to the invention, suitable for holding a syringe during administration. The holder is loaded and comprises a syringe held in its inner space.

Fig. 32 shows a sectional view of a processing holder as of Fig. 27-31 without a syringe.

Fig. 33 shows an illustration of a holding mechanism for the syringe inside the processing holder of Fig. 27-32.

Fig. 34 shows perspective views of a clip-on part for a syringe plunger comprising a radiation barrier. Fig. 35 shows a perspective view of a syringe plunger with the clip-on part as of Fig. 34 attached.

Fig. 36 shows a perspective view of processing holder of Fig. 27-32 including cap and lid.

Fig. 37 shows an exploded perspective view of all parts of the loaded processing holder of Fig. 27-32, further including cap and lid.

DETAILED DESCRIPTION OF EMBODIMENTS

Fig. 1-5 show an embodiment of a sleeve 310 of a holder 300 according to the invention, suitable for holding a syringe 200 during automated filling with a radiopharmaceutical or other radioactive substance in production, and during transport. Fig. 6-10 show a matching lid 360 suitable for closing an inner space 320 of the sleeve 310 after the syringe 200 has been filled, and during transport. The sleeve 310 and the lid 360 form the main constituents of a processing or transportation holder 300 for a syringe, in an embodiment of the invention. Fig. 11-13 show the holder 300 formed from combining the sleeve 310 as shown in Fig. 1-5 and the lid 360 as shown in Fig. 6-10, with a syringe 200 received therein.

The sleeve 310 has a circumferential wall 311 and a bottom 314 and defines a generally cylindrical inner space 320 having an open top end 322 for top-down insertion of a syringe 200 into the inner space 320. The inner space 320 comprises a main section 323 having a first diameter for receiving the main part of the barrel 210 of the syringe 200, and a bottomside section 324 having a relatively smaller diameter for receiving the tip 211 of the barrel 210.

The lid 360 has an axially elongated shape and defines a generally cylindrical inner space 319, in extension to the generally cylindrical inner space 320 of the sleeve 310, for receiving a plunger 220 of a syringe 200 to be held therein.

During filling, the syringe barrel 210 is inserted into the inner space 320 in a top-down movement. The barrel 210 is then filled with the radiopharmaceutical, and the plunger 220 inserted into the barrel 210. Finally, the lid 360 is placed on the sleeve 310 for sealing the inner space 320. The entire outer surface of the sleeve 310 forms a rounded contour having a bulge 311a in a middle portion of the circumferential wall 311 , while the corresponding inner surfaces of the sleeve 310 have flatter wall segments and relatively sharper transitions, thereby resulting in a non-uniform wall thickness of the sleeve 310. The stepped configuration between the different diameter sections of the inner space 320 is also reflected on the outer surface in a rounded manner. Also on the lid 360, the outer surface forms a rounded contour, while the inner surface has flatter wall segments and relatively sharper transitions, resulting in a non- uniform wall thickness.

For optimized sealing against radiation, the lid 360 comprises a circumferential downwardextending lip 327 configured to radially enclose a tapering upper peripheral portion of the sleeve 310 in a form-fitting manner.

Fig. 14-18 show an embodiment of a sleeve 410 of a holder 400 according to the invention, suitable for holding a vial 200a during automated filling with a radiopharmaceutical in production, and during transport. Fig. 19-23 show a matching lid 460 suitable for closing an inner space 420 of the sleeve 410 after the vial 200a has been filled, and during transport. The sleeve 410 and the lid 460 form the main constituents of a processing or transportation holder 400 for a vial 200a, in an embodiment of the invention. Fig. 24-26 show the holder 400 formed from combining the sleeve 410 as shown in Fig. 14-18 and the lid 460 as shown in Fig. 19-23, with a vial 200a received therein.

Also the sleeve 410 has a circumferential wall 411 and a bottom 414 and defines a generally cylindrical inner space 420 having an open top end 422, which in this embodiment is for top- down insertion of a vial 200a into the inner space 420. The inner space 420 of the sleeve in this embodiment only comprises one section and has a constant inner diameter.

The lid 460, when compared to the embodiment discussed previously, has a flatter shape defining no or, as shown, a small inner space.

During filling, the vial is inserted into the inner space 420 in a top-down movement. The vial 200a is then filled with the radiopharmaceutical or other radioactive substance. The vial 200a is then closed with a closure element 220a. Finally, the lid 460 is placed on the sleeve 410 for sealing the inner space 420. The entire outer surface of the sleeve 410 forms a rounded contour having a bulge 411a in a middle portion of the circumferential wall 411 , while the corresponding inner surfaces of the sleeve 410 have flatter wall segments and relatively sharper transitions, thereby resulting in a non-uniform wall thickness of the sleeve 410. Also on the lid 460, the outer surface forms a rounded contour, while the inner surface has flatter wall segments and relatively sharper transitions, resulting in a non-uniform wall thickness.

For optimized sealing against radiation, also in this embodiment, the lid 460 comprises a circumferential downward-extending lip 427 configured to radially enclose a tapering upper peripheral portion of the sleeve 410 in a form-fitting manner.

Fig. 13 shows a version of the longitudinal section of Fig. 11 with added schematic paths of y-radiation emitted from a radiopharmaceutical contained in the syringe 200. Fig. 26 shows a version of the longitudinal section or Fig. 24 with added schematic paths y of y-radiation emitted from a radiopharmaceutical contained in the vial 200a.

As the syringe 200 or the vial 200a are not spherically symmetric and due to effects of selfshielding, the radiation will not be emitted evenly in all directions from the geometric center of the body of radioactive material, as in the simplified illustrations. However, as an approximation, the simplified illustrations still show how the shape of the sleeves 310, 410 and lids 360, 460, with varying wall thickness, softer outside contours and a bulge 311a, 411a in a middle portion of the circumferential wall 311 , 411 , facilitate for the radiation to pass through approximately equal lengths of shielding material, i.e. sleeve 310, 410 or lid 360, 460, independent of its direction in space, at equal distances to the radiation source (with lengths to pass decreasing with increasing distance from the radiation source according to inverse square law). An optimization of the geometry in real life, starting from the idealized geometry shown and taking into account actual shapes of bodies of radioactive materials, types of radioactive material and shielding material types, self-absorption effects and other parameters, can, for example, be made using Monte Carlo simulations. The optimization will maintain the basic shape of the housing, as described, but may lead to variations in thicknesses and shapes of, for example, the bulge 311a, 411a, when starting from the idealized geometries shown in Fig. 1-13 or Fig. 14-23, respectively.

The sleeves 310, 410 and the lids 360, 460 of both embodiments of the holders 300, 400 shown in Fig. 1-26 are injection molded parts made from a filled polymer material, which comprises a polymer base material and a high proportion of a filler material in the form of a metal or ceramic powder comprising a heavy element. They may be single shot injection molded parts, or may be multiple shot injection molded parts or two or more form-fittingly assembled injection molded parts. Due to the high proportion of the heavy element filling, the material has good radiation shielding properties. At the same time, the material can be formed in complex geometries as described in a straightforward polymer injection molding process, which is much cheaper and more flexible than MIM, CNC or sintering. High filler levels can be obtained using technologies such as those disclosed in WO 2017/028939 A1 and WO 2018/141587 A1. For example, the filled polymer material can be a polyamide highly filled with tungsten metal powder to obtain a basis weight of the filled polymer material of 12,5 gsm or 14,5 gsm.

Further housing structures may enclose the sleeves 310, 410 and the lids 360, 460 of both embodiments of the holder shown in Fig. 1-26. The housing structures may include polymer shells, a polymer liner, rubbery impact protection elements, a sealing ring, and the like.

Fig. 27-31 show another embodiment of a holder of the invention, suitable for holding a syringe during administration, which comprises a processing holder 100 and a syringe 200 held therein. Fig. 32 shows the holder 100 without the syringe 200.

The holder 100 comprises a sleeve 110 enclosing an inner space 120 for receiving the syringe 200. The sleeve 110 comprises a circumferential wall 111. In the inner space of the sleeve 110, an inner shell 112 is received. Both the sleeve 110 and the inner shell 112 are molded parts made from a filled polymer material, as described in more detail further below. Both the sleeve 110 and the inner shell 112, as well as the inner space 120, are essentially cylindrical in shape.

Further comprised in the holder is a window 130 made from lead glass. The window 130 is received in a narrow longitudinal gap correspondingly formed in both the sleeve 110 and the inner shell 112 and allows a practitioner to view the inner space 120 and hence the syringe 200 and its content from the outside. Since the radiation shielding property of the window material may be less pronounced that the radiation shielding properties of the material forming for other parts of the housing, the wall thickness of the circumferential wall 111 may be locally increased around the window 130, and the material thickness of the window 130 higher than the material thickness of the circumferential wall 111 further away from the window 130. The inner space 120 comprises a bottom opening 121 to expose a tip 211 of the barrel 210 of the syringe 200. The bottom opening 121 comprises a stop contour 121a to define an end position of the syringe 200 in the inner space 120. The syringe 200 can be inserted into the inner space 120 by longitudinal movement from top to bottom until the front end of the syringe barrel 210 hits the stop contour 121a.

A holding mechanism 140 to releasably hold the syringe 200 in place inside the inner space 120, after being inserted into the inner space 120 in a longitudinal movement from top to bottom, is arranged close to a top end opening 122 of the inner space 120.

The holding mechanism 140 is shown in isolation in Fig. 33, when viewed in a longitudinal direction. The left side illustration of Fig. 24 shows a relaxed state and the right side illustration a state where the holding mechanism 140 is triggered for release.

The holding mechanism comprises a ring 141 formed from an elastically deformable polymer material, that is elliptical in shape when in a relaxed state and carries a number of teeth 142 inwardly protruding from the ring 141 along its less curved sections. The dimension of the ring 141 , the bias of the elastic material, and the shape of the teeth 142 is such that a syringe 200 can be inserted through the ring 141 and into the inner space 120 in a longitudinal movement from top to bottom without much resistance, but that a backward movement is effectively avoided by the teeth 142 that superficially penetrate into the walls of the polymer syringe barrel 210.

The ring 141 also comprises two buttons 143 outwardly protruding from the ring 141 , oppositely arranged at its most curved sections. The buttons 143 are accessible from the outside of the sleeve 110. As illustrated in the right side illustration of Fig. 27, when the buttons are pushed towards each other, the oval ring 141 is compressed against the bias to take a more circular shape. This change in shape pulls the teeth 142 out of the syringe barrel 210 and releases the syringe 200. As a consequence, when the syringe holder 100 is held with its top facing downwards, the syringe 200 can slide out from the inner space 120 in a longitudinal backward bottom to top movement.

Going back to describing the sleeve 110 and the inner shell 112, the circumferential wall 111 has a variable wall thickness. Specifically, the circumferential wall 111 has a bulged shape, with an increased wall thickness in the middle part of the housing 110. This is where the intensity of radial radioactive emission peaks. Both the sleeve 110 and the inner shell 112 are molded parts made from a highly filled polymer composition. The polymer matrix is formed from polyamide for both the sleeve 110 and the inner shell 112. The filler material is a homogenously dispersed powder material that differs between the sleeve 110 and the inner shell 112. The filler material for the sleeve 110 is a metallic tungsten powder. The filler material for the inner shell is a metallic aluminum powder. The filling degree, in both cases, exceeds 40 vol%, such that the density of the filled polymer materials used for the sleeve 110 and the inner shells 112, respectively, approximate 15 g/ccm and 3 g/ccm. This is made possible by adding specific additives of the polymer material, as disclosed in WO 2017/028939 A1.

The highly filled compositions have very good shielding properties that approximate the shielding properties of the isolated filling materials tungsten and aluminum, but they can conveniently be formed by injection molding and hence produced as complexly shaped parts in a relatively inexpensive and straightforward production.

The aluminum filled inner shell 112 has an ability to absorb p-radiation. The tungsten filled outer shell 111 can absorb y-radiation. Since tungsten would not be necessary for absorbing P-radiation, and since during absorption of p-radiation produces secondary y-radiation, the multi-layer design allows for an overall reduced tungsten layer thickness when compared to a single layer tungsten housing. This saves cost for expensive tungsten material and significantly reduces weight of the holder 100.

In the transport position, as shown in Fig. 33, the bottom opening 121 of the inner space 120 is covered by a detachable cap 150. The cap 150 is made from an identical material as the sleeve 110, i.e. is also a molded part made from a highly tungsten metal filled polyamide. Before use, the cap 150 can be detached from the sleeve 110 to mount a needle to the tip 211 of the barrel 210 of the syringe 200.

Further, in the transport position, as shown in Fig. 36, the top end opening 122 of the inner space 120 is covered by a lid 160. The lid 160 can likewise be made from a filled polymer material for shielding. The lid 160 has an elongated shape for receiving the drawn-out syringe plunger 220. Before use, the lid 160 can be detached from the housing 110 to be able to push the plunger 220. The syringe 200 can be protected against radiation emission on its back side. More specifically, as shown in Figs. 34-35, a clip-on part 230 comprising a disk-shaped barrier 231 is attached to the plunger 220. The clip-on part 230 extends between the plunger stamp 221 and the thumb rest 223. It consists of two parts, that are fitted to the cross profile 222 connecting the stamp 221 and the thumb rest 223 from opposite sides and fixed by a clip-on connection. The disk-shaped barrier 231 is formed from two half-disks, one on each of the two parts. The barrier 231 is made from an identical material as described above for the sleeve 110, i.e. is also a molded part made from a highly tungsten metal filled polyamide. The remainder of the two parts can be formed from standard non-filled polymer material through 2K-injection molding technology. The barrier 231 has the same diameter as the stamp 221 and rests directly adjacent to the stamp 221. As such, the barrier 231 fully blocks any back side emission of radiation through the top end opening 122 of the sleeve 110.

The incorporation of a back side radiation protection to the syringe 200 itself has a main advantage that radiation emission from the back side of the syringe is also shielded when the lid 160 is detached for use.

The holder 100 can be assembled and loaded with a syringe 200 by inserting all individual pieces into each other by movement along a longitudinal axis, as best seen in Fig. 37. In this context, the holder can additionally comprise a head piece 113 attached to the bottom end of the sleeve 110 to 111 define a bottom opening 121 and stop contour 121a, as well as the bayonet lock contour for mounting the cap 150. The head piece 113 can made from an identical material as the sleeve 110, i.e. is also a molded part made from a highly tungsten metal filled polyamide.

Claims

1. A processing or transportation holder for a syringe or a vial containing a radiopharmaceutical or other radioactive substance, the holder comprising: a sleeve having a circumferential wall defining a generally cylindrical inner space, an open top end for top-down insertion of a barrel of the syringe, or a vial, into the inner space, and, preferably, a closed bottom; wherein the sleeve is a molded part made from a polymer material filled with a particulate material comprising a heavy element; and wherein at least part of the outer surface of the sleeve forms a rounded contour having a bulge in a middle portion of the circumferential wall, while the corresponding inner surfaces of the sleeve have flatter wall segments and relatively sharper transitions, thereby resulting in a non-uniform wall thickness of the sleeve.

2. The processing or transportation holder of claim 1 , wherein the generally cylindrical inner space of the sleeve comprises a main section having a first diameter and a bottom-side section having a relatively smaller diameter, and wherein the outer surface of the sleeve reflects the stepped configuration while maintaining a generally rounded overall shape.

3. The processing or transportation holder of any one of the preceding claims, wherein the processing or transportation holder further comprises a lid removably attached to the open top end of the sleeve for sealing the inner space the lid, wherein the lid is a molded part made from a polymer material filled with a particulate filler material comprising a heavy element.

4. The processing or transportation holder of any one of the preceding claims, wherein the outer surface of the lid forms a rounded contour, while the inner surface of the lid has flatter wall segments and relatively sharper transitions, thereby resulting in a non- uniform wall thickness of the lid.

5. The processing or transportation holder of any one of the preceding claims, wherein a circumferential rim is formed on an edge of the sleeve that defines the open top end, or on a complementary lower surface of the lid, the rim axially protruding upwards from the sleeve or downwards from the lid, and wherein the lid or sleeve comprises a complementary grooved contour configured to receive the axially protruding rim of the sleeve or lid.

6. The processing or transportation holder of any one of the preceding claims, wherein the lid comprises a circumferential downward-extending lip configured to radially enclose an upper peripheral portion of the sleeve.

7. The processing or transportation holder of any one of the preceding claims, wherein the lid has a generally flat shape.

8. The processing or transportation holder of any one of claims 1 to 6, wherein the lid has an axially elongated shape and defines a generally cylindrical inner space for receiving a plunger of the syringe.

9. The processing or transportation holder of any one of the preceding claims, wherein the holder further comprise housing structures enclosing the sleeve and the lid.

10. The processing or transportation holder of any one of the preceding claims, wherein the content of the particulate filler material in the polymer material of the sleeve or lid is 30 vol% or greater, preferably 40 vol% or greater, more preferably 50 vol% or greater, based on the total volume of the filled polymer material.

11. The processing or transportation holder of any one of the preceding claims, wherein the density of the filled polymer material of the sleeve or lid is 10 g/ccm or greater, preferably 12 g/ccm or greater, more preferably 14 g/ccm or greater.

12. A syringe for receiving a radiopharmaceutical, the syringe comprising a barrel and a plunger having a plunger stamp, wherein the plunger stamp comprises a barrier in the form of a molded part made from a polymer material filled with a particulate filler material comprising a heavy element.

13. The syringe of claim 12, wherein the plunger is a monolithic part made from 2K injection molding and the barrier is formed by one of the components of the monolithic 2K injection molded part.

14. The syringe of claim 12, wherein the barrier is attached to the plunger stamp as a separate part.

15. A filled processing or transportation holder that comprises a processing or transportation holder according to any one of claims 1 to 11 and a syringe or a vial containing a radiopharmaceutical or other radioactive substance received in the inner space of the sleeve.