HK1077395B - Container for vial of radiopharmaceutical and set for its infusion in a patient or for its transfer elsewhere - Google Patents

Description

Container for vial of radiopharmaceutical and assembly for injecting it into a patient or for delivery to another site

Technical Field

The present invention relates to containers for vials of radiopharmaceutical and to an assembly for injecting the radiopharmaceutical from the vial enclosed in the container into a patient or for delivery to another site.

Background

Radiopharmaceuticals, in particular but not exclusively radiopharmaceuticals containing beta-emitting radioisotopes, commonly designated for injection into patients, are nowadays contained in vials for intravenous injection, equipped with a hermetically sealed rubber cap through which a syringe needle is inserted to extract the radiopharmaceutical to be injected or to transport it to a different container at another site, typically with the radiopharmaceutical vial being stored in turn in a lead container.

This type of radioprotection uses lead containers which have a number of drawbacks, both from the point of view of storage and transport of the radiopharmaceutical and from the point of view of its subsequent handling and use. The lead container is heavy. It creates a detrimental factor for the transport and storage of radiopharmaceuticals. But also the lead container hinders the visibility of the contents of the radiopharmaceutical vial due to its opacity. The operator has to open it to check its content and preservation status, as well as to check the vials for any leaks, with a major risk of contamination, and, if necessary, check the radioactive dose.

Moreover, in the administration of a radiopharmaceutical to a patient or when transferring it to another container, the operator operates it with a syringe or some other device, with the risk of receiving a radiation dose, even with a consequent contact with the radiopharmaceutical itself.

One non-negligible problem in intra-arterial injection is to accurately measure the amount of radioactive material injected. This problem is addressed, for example, in the following patents: U.S. patent No.5,529,189granted to Feldschuh on January 251996. The object of this patent is to provide a disposable assembly for administering an accurate dose of radioactive material to an object with an accuracy of at least 99.9% wt. Nevertheless, even if this objective can be effectively achieved, handling of the radioactive substance vial should be careful, as it is essentially dangerous for the operator.

Disclosure of Invention

It is therefore an object of the invention described herein to provide a container for vials of radiopharmaceutical that is made of a material that shields the operator from radioactive radiation, particularly beta-emitting isotopes.

It is another object of the present invention to provide a lightweight container that is easy to manage.

It is yet another object of the present invention to provide a container for a vial of radiopharmaceutical which enables the contents to be identified without the need to open it.

Another object of the present invention is to allow shipment and transport of pre-calibrated, customized radiopharmaceuticals for individual patients within containers, the radiopharmaceuticals in the containers being capable of being checked by an operator corresponding to a desired dose amount.

Yet another object of the present invention is to allow the radiopharmaceutical to be injected into a patient or transported elsewhere without the need to handle the radiopharmaceutical vial.

A first inventive aspect of the present invention aims to achieve the above mentioned objects by providing a container for radiopharmaceutical vials made of a material suitable for shielding the operator from the radioactive radiation generated by the radiopharmaceutical through the vial, the container comprising a body, the cavity of which is capable of containing the radiopharmaceutical vial, and a lid connected to the body to close the container, said lid being provided with a central through hole.

A further object of the invention is to allow the injection of a radiopharmaceutical into a patient or its transfer to another site without the need for the other to aspirate the radiopharmaceutical with a syringe for extraction from the vial.

A second additional object of the invention is to allow the quantity of radiopharmaceutical injected into a patient or delivered elsewhere to a different subject to be measured accurately by means of the readout volume.

A second aspect of the invention is directed to the above-mentioned supplementary objects by providing an assembly in combination with the above-mentioned container containing a vial of radiopharmaceutical, and which comprises:

-a saline solution bottle containing a saline solution;

-an injection catheter equipped with double connectors, one for inserting a needle into the saline bottle and the other for inserting the needle of the cap of the radiopharmaceutical vial through the central through hole of the lid in a manner not to be immersed in the radiopharmaceutical;

-a second injection catheter equipped with dual connectors, one for inserting a first needle into the cap of the radiopharmaceutical through the central through hole of the cap, and another for inserting a second needle into the patient's vein or elsewhere, the first needle of the second catheter being long enough to reach the bottom of the vial of radiopharmaceutical.

Drawings

The invention described above will be described with reference to preferred embodiments, however, it will be understood that various modifications may be made without departing from the scope of the invention, and reference is made to the accompanying drawings, in which:

fig. 1 presents a side view and an axial longitudinal section of the left half of the body, and its separate lid in the right half, showing the two parts of a radiopharmaceutical vial container according to the invention;

FIG. 2 shows a top view of the container of FIG. 1;

FIG. 3 shows a top view of a portion of an assembly for extracting a radiopharmaceutical using the radiopharmaceutical vial container shown in FIGS. 1 and 2;

FIG. 4 provides a perspective view of a container and assembly according to the present invention during an injection operation;

fig. 5 shows a longitudinal section on an enlarged scale of the container of fig. 1 with the needle inserted.

Detailed Description

Referring to fig. 1 and 2, there is shown a radiopharmaceutical vial container in accordance with the present invention, in partial cross-sectional view, partial side view and top view, respectively. It comprises a body 1 and a lid 2. One vial of radiopharmaceutical for intravenous injection is shown in phantom in figure 1 and carries figure number 3. The radiopharmaceutical vial 3 is a conventional cylindrical UNI 6255 pressed glass vial or other similar body commonly used for the same purpose, with an external widened mouth 30 on which a rubber cap (not shown) is hermetically sealed with an aluminium crimp cap seal. The vial 3, for example a 20ml vial, has a cylindrical wall 31, a portion 33 of a bottom 32, widening downwards from the mouth 30 to the cylindrical wall 31, and contains a beta-radioisotope, for example a beta-radioisotope, in the vial⁹⁰Y-biotin，⁹⁰Y-DOTATOC，⁹⁰Y-Moabs and others.

The body 1 is preferably cylindrical and has a cavity 10, also cylindrical, capable of housing the vial 3 of radiopharmaceutical, with a movable connector. That is to say, it is preferable that the diameter of the cavity 10 is slightly greater than the outer diameter of the wall 31 of the vial 3, so as to avoid excessive radial movement of the wall 31 resting on the bottom 11 and consequent impact against the vertical wall 12 of the body 1.

At its upper part the cavity 10 widens into a chamber 13 of larger diameter, the inner wall of which has a threaded portion 14. As can be seen from fig. 1, the height of the cavity 10 is such that the vial projects with its mouth 30 beyond the upper edge of the vertical wall 12 of the body 1.

The cap 2 is screwed on the body 1 to close the container. The lid 2 is similarly cylindrical and is preferably made of an upper disc 20 in one piece with the same diameter as the body. The upper disc 20, the rim of which has a pressed or knurled edge 21 to increase the tightness of fit of the lid 2, extends downwards with a cylinder-like part 22 with a diameter measuring smaller than that of the upper disc. The dimensions of the cylindrical portion 22 are such that it can fit into the chamber 13 of the body 1 of smaller diameter. The cylindrical portion 22 has an external counter-thread 23 for producing a threaded engagement with the internal thread 14 of the body. It is obvious that the closure of the lid 2 on the body 1 of the container can also be of different design, for example, using a plug connector.

This cap 2 is screwed completely onto the body 1 and the vial of radiopharmaceutical is held in position between the bottom 11 of the body 1 and the underside of the cap 2 so that it cannot rotate. At this end, as shown in figure 1, the cap is internally hollow, having a cylindrical upper chamber 24 of slightly larger diameter than the mouth 30 of the vial, flaring downwardly into a hollow frusto-conical portion 25 which follows the profiled portion 33 of the vial between the mouth 30 and the cylindrical wall 31.

Furthermore, as shown in figure 2, the lid 2 has, above its cylindrical upper compartment 24, a central through hole 26, with a diameter close to the central part of the rubber cap of the radiopharmaceutical vial 3, which allows the insertion of an extraction needle. For ease of operation, the central through bore 26 has an outwardly facing upper flared portion 27.

According to the invention described above, at least the body 1, but preferably also the cover 2, is made of a transparent material. In this way, an operator can check the content and volume of the vial of radiopharmaceutical without having to remove the cap 2 and open the vial. The dose can therefore be calculated from the concentration (activity/volume) stated by the manufacturer, thus avoiding the operator's own exposure to ionizing radiation.

If the radiation emitted by the radiopharmaceutical is beta-radiation, the material from which the body 1 is made is polymethyl methacrylate, known under the trade name plexiglass.

The lid 2 can also be made of the same material.

Polymethyl methacrylate has excellent properties against radiation emissions, especially against beta-radiation isotopes.

In addition, polymethyl methacrylate has a low bulk weight, and therefore can provide a lightweight, easily managed container.

The wall thicknesses of the container body and lid will depend on the beta-radiation energy of the isotopes contained. This thickness can be determined by the expert in the field simply on the basis of general knowledge of the object.

In various embodiments of the invention, the radiopharmaceutical may have a mixed emitter, i.e., an isotope that radiates both beta-and gamma-rays (including 511KeV annihilated photons) and a mixed emitter, e.g.¹³¹I and¹⁷⁷Lu。

in [ 2 ]¹⁸F]In the particular case of FDG, this device is particularly suitable for reducing the exposure to health-related work of radiant energy, given its extensive use in clinical practice. In this case both the container and the lid are made of transparent material, either polymethylmethacrylate or glass rich in lead or tungsten, depending on the gamma-radiation energy. In this case, the second infusion catheter, which delivers the radiopharmaceutical to the patient, should also be enclosed within a suitably shielded introducer.

In this particular case, the container and the lid will be made of polymethyl methacrylate and contain a certain amount of lead so as to ensure the required radiation protection and transparency of the walls of the body and the lid. The choice of materials and the determination of the thickness of the walls of the body and the lid in this implementation are also empirical issues to those skilled in the art.

The container according to the invention provides the advantage of allowing shipment and transport of pre-calibrated radiopharmaceuticals customized to individual patients. Inside the container an operator can check the desired volume/quantity without having to handle the vial.

The container described above allows the radiopharmaceutical to be injected into a patient or transported elsewhere without the need to handle the vial. The operator is in fact able to extract the radiopharmaceutical with a syringe while the vial containing it remains contained in the container, which provides an effective radioprotection.

The present invention thus solves the problem of providing a device that allows injecting a radiopharmaceutical into a patient or transferring it elsewhere to another radiopharmaceutical body, without the need for extraction from its vial by means of a syringe, and with accurate checking of the volume of radiopharmaceutical injected into a patient or transferred to another body.

To this end, the invention provides an assembly for injecting a radiopharmaceutical from a vial contained in a container into a patient or for delivery elsewhere. The infusion assembly described above, combined with the container containing the vial of radiopharmaceutical, constitutes a complete assembly for the administration of the radiopharmaceutical, without further operations and without direct extraction procedures by the operator.

Referring to fig. 3 and 4, part of the assembly and the container 1-2, respectively, and the assembly according to the invention are shown in an injection operation.

The assembly comprises a conventional saline solution bottle 4 associated with the container 1-2 of the vial 3 of radiopharmaceutical, an infusion catheter and a second infusion catheter, respectively designated collectively by the reference numerals 5 and 6.

The saline solution bottle 4 may be 250ml, for example. The use of saline solution will be described below.

The first injection catheter 5 is conventionally provided with a double connector with a first needle 50, a flow regulator 51 and a second needle 52. The needle 50 is of a known type suitable for insertion into a bottle of saline solution 4 and is connected to a drop counter 53. The drop counter is connected to the second needle 52, which is a metal needle, by a small tube 54.

The second needle 6, equipped with a double connector according to the invention as described herein, has a first needle 60, a flow regulator 61 and a second needle 62. Needle 60 is of the injection type and is connected to second needle 62 by connector 63 and small tube 64, which is an injection needle via connector 65.

In an injection operation, shown in figure 4, the saline solution bottle 4 is conventionally suspended in a holder 7 connected to a support 8, provided with a supporting shelf 9. The first injection catheter is inserted into the cap of the bottle 4 together with the first needle 50, while the second needle 52 enters the cap of the vial 3 of radiopharmaceutical through the flared portion 27 of the central through hole 26 of the cap 2, in such a way as not to dip into the radiopharmaceutical, as shown in figure 5, which is an enlarged view of the detail of figure 4, the starting level of which is indicated by the letter L.

The second infusion catheter 6 also has a first needle 60 that enters the cap of the vial of radiopharmaceutical through the flared portion 27 and the through hole 26 of the cap 2, while a second needle 62 is inserted in the brachial vein of a patient. The first needle 60 is long enough to reach the bottom of the radiopharmaceutical vial, where it must be held in place to completely withdraw the radiopharmaceutical, as shown in fig. 5.

Providing flow through a saline solution bottle 4, a first infusion catheter 5, a vial 3 within the container 1-2, and a second infusion catheter 6 allows the radiopharmaceutical to be gravity-transferred. The saline solution is fed from the bottle 4 into the radiopharmaceutical vial 3 by flow regulation by the flow regulator 51. The inflow of saline solution causes an increase in the pressure of the radiopharmaceutical in vial 3, which has its entire content drawn by second infusion catheter 6, whose flow rate is regulated by flow regulator 61.

This delivery can be accomplished using air or some other gas-containing liquid as the vector fluid if one wishes to deliver the radiopharmaceutical elsewhere. For this purpose, an injection catheter may be used as part of the present invention, or other suitable device.

The same assembly described above can be used to transfer the radiopharmaceutical from its vial to another body, for example, to differentiate the dose, using air as the driving medium.

The handling of the components is not hazardous for the operator. The injection catheter and in particular the second injection catheter are explicitly handled as hazardous material like a radiopharmaceutical vial. After extraction, the catheter and the loose cap, the radiopharmaceutical vial, fall out of its container into a radioactive waste collector, whereas the container according to the invention can be reused.

Furthermore, the container according to the invention is suitable for use with automated and even robotic systems for preparing individual doses.

The container according to the invention and its injection assembly are also suitable for use in the management of generally toxic anaesthetics, such as anticancer agents.

Claims (11)

1. Container for radiopharmaceutical vials containing a radiopharmaceutical to be extracted through a needle inserted into a hermetic cap fixed to the mouth of the radiopharmaceutical vial, said container being made of a material suitable for shielding the operator from the radioactive radiations generated by the radiopharmaceutical through the vial, characterized in that it comprises: a body made of a transparent material and having a cavity capable of containing a vial of radiopharmaceutical; and a cover coupled to the body for closing the container, said cover having a central through hole.

2. Container according to claim 1, characterized in that the vial of radiopharmaceutical is movably connected to the cavity of the body and that the lid is in contact with the mouth of the vial of radiopharmaceutical when the container is in the closed position, the central through hole in the lid being located above the cap of the vial of radiopharmaceutical.

3. Container according to claim 1, characterized in that the radiation emitted by the radiopharmaceutical is β -radiation and the material of which the body and the lid are made is polymethyl methacrylate.

4. A container according to claim 3, wherein the body and the lid are made of materials having a thickness dependent on the beta-radiation energy of the radioisotope contained therein.

5. Container according to claim 1, characterized in that the radiation emitted by the radiopharmaceutical is β -and γ -radiation and the material of which the body and the lid are made is polymethyl methacrylate containing lead as an additive.

6. The container of claim 1, wherein the cap is connected to the body by a threaded connector.

7. Container according to claim 5, characterized in that the radiopharmaceutical contains [18F ] FDG.

8. A container according to claim 1 or 2, for use with toxic medicaments.

9. An assembly for injecting a radiopharmaceutical into a patient from a vial contained in a container as defined in claim 1, in combination with said container containing a vial of radiopharmaceutical, comprising:

-a saline solution bottle containing a saline solution;

-an injection catheter equipped with double connectors, one for inserting a needle into the saline bottle and the other for inserting the needle of the cap of the radiopharmaceutical vial through the central through hole of the lid in a manner not to be immersed in the radiopharmaceutical;

-a second injection catheter equipped with dual connectors, one for inserting a first needle through the central through hole of the cap into the cap of the vial of radiopharmaceutical and another for inserting a second needle into the vein of the patient, the first needle of the second injection catheter being long enough to reach the bottom of the vial of radiopharmaceutical.

10. The assembly of claim 9, wherein a second infusion catheter for delivering the radiopharmaceutical to the patient is also housed within the appropriate shielding guide.

11. An assembly according to claim 9, characterized in that it is used for toxic drugs.