MX2014008758A

MX2014008758A - Radioisotope elution system.

Info

Publication number: MX2014008758A
Application number: MX2014008758A
Authority: MX
Inventors: Scott H Mayfield; Kevin R Martz; Anthony K Lewis
Original assignee: Mallinckrodt Llc
Priority date: 2012-01-19
Filing date: 2013-01-17
Publication date: 2014-08-27
Also published as: BR112014017497B1; CA2861361C; BR112014017497A2; BR112014017497A8; CA2861361A1; WO2013169314A3; WO2013169314A2; MX349633B

Abstract

An elution tool (150) for a radiopharmaceutical elution system includes an elution tool. The tool has a vial chamber sized and shaped for receiving an elution vial (17). An access opening is aligned with a septum of the elution vial when the elution vial is received in the vial chamber. An elution tool lid (158) is secured to the elution tool body by a hinged connection. The elution tool lid is rotatable at the hinged connection (186) and movable relative to the elution tool body between an occluded position and an exposed position. The tool also includes a latching mechanism (188) for selectively and releasably locking the lid in the occluded position.

Description

RADIOISOTOPOS ELUTION SYSTEM BACKGROUND OF THE INVENTION The present disclosure relates generally to a system for eluting radioisotopes and tools for use therewith.

Nuclear medicine uses radioactive material for diagnostic and therapeutic purposes by injecting a patient with a dose of the radioactive material, which is concentrated in certain organs or biological regions of the patient. The radioactive materials typically used for nuclear medicine include Technetium-99m, Indium-111, and Talium-201 among others. Some chemical forms of radioactive materials are naturally concentrated in a particular tissue, for example, radioiodine (1-131) is concentrated in the thyroid. The radioactive materials are often combined with a labeling or organ searching agent, which targets the radioactive material for the desired biological organ or region of the patient. These radioactive materials alone or in combination with a labeling agent are typically referred to as radiopharmaceuticals in the field of nuclear medicine. At relatively low doses of radiation from a radiopharmaceutical, a radiation imaging system (eg, a gamma camera) can be used to provide an image of the organ or region REF: 249988 biological in which the radiopharmaceutical is located. Frequently, irregularities in the image are indicative of a pathology, such as cancer. Higher doses of a radiopharmaceutical can be used to deliver a therapeutic dose of radiation directly to the pathological tissue, such as cancer cells.

A variety of systems are used to generate, enclose, transport, dispense and administer radiopharmaceuticals. Such a system includes a radiopharmaceutical generator, which includes an elution column and an input connector (e.g., an input needle) and an output connector (e.g., an output needle) in fluid communication with the elution column. Typically, a radiopharmaceutical or technician fluidly connects a vial of eluent (e.g., a vial containing saline solution) to the inlet connector and fluidly connects an unoccupied elution vial (e.g., a vial having an internal vacuum at least partial) to the output connector. The vacuum in the unoccupied elution vial extracts the eluent (eg, saline) from the eluent vial through the elution column and into the elution vial. The saline elutes radioisotopes as it flows through the elution column so that the saline solution containing radioisotopes fills the elution vial. The elution vial is typically housed in its own protective package against the radiation, sometimes referred to as pharmaceutical protection or elution protection.

This section of Background is proposed to introduce the reader to various aspects of the technique that may be related to various aspects of the present description, which are described and / or claimed later. It is believed that this discussion is useful in providing the reader with background information to facilitate a better understanding of the various aspects of the present disclosure. Therefore, it should be understood that those statements should be read from this point of view, and not as admissions of the prior art.

BRIEF DESCRIPTION OF THE INVENTION In one aspect, an elution tool for a radiopharmaceutical elution system includes a body of the elution tool having an upper part, an opposing bottom and an opening in the upper part. The tool has a vial chamber extending from the opening in the upper part towards the bottom and which is dimensioned and configured to receive an elution vial through the opening in the upper part. An access opening extends through the bottom of the vial chamber and is aligned with a septum of the elution vial when the elution vial is received in the vial chamber. A lid of the elution tool is secured to the body of the tool of elution by an articulated connection adjacent to the upper part of the body of the elution tool. The lid of the elution tool is rotatable in the articulated and movable connection in relation to the body of the eluting tool between an occluded position, in which the lid of the elution tool occludes the opening in the upper part of the body of the elution tool. the elution tool, and an exposed position, in which the lid of the elution tool does not occlude the opening in the upper body portion of the elution tool to allow the elution vial to be inserted into and removed from the chamber of little bottle The body and lid of the tool include at least one of depleted uranium, tungsten, plastic impregnated with tungsten and lead. The tool also includes a latch mechanism for selectively and releasably locking the lid in the occluded position.

In another aspect, the elution tool includes a body of the elution tool configured to be held in a user's hand. A dispensing lid can be removably secured to the bottom of the body of the elution tool. The dispensing lid includes a body of the dispensing lid having a dispensing access opening that is aligned with the access opening of the body of the elution tool when the dispensing lid is secured to the body of the elution tool. A dispensing cap is rotatably secured to the body of the dispensing lid to selectively occlude and expose the dispensing access opening.

There are several corrections of the qualities observed in relation to the aforementioned aspects of the present description. Additional qualities may also be incorporated in the aforementioned aspects of the present disclosure. These corrections and additional qualities may exist individually or in any combination. For example, various qualities set forth below in connection with any of the illustrated embodiments of the present disclosure may be incorporated in any of the aspects described above of the present disclosure, alone or in any combination.

BRIEF DESCRIPTION OF THE FIGURES FIGURES 1A and IB are perspective views of one embodiment of a radioisotope eluting system.

FIGURE 2 is a top plan view of the radioisotope elution system of FIGURE 1.

FIGURE 3 is a cross-sectional view of the radioisotope eluting system of FIGURE 1 taken along line 3-3 in FIGURE 2.

FIGURE 4 is a view with the separate parts of the radioisotope eluting system of FIGURE 1.

FIGURE 5 is an enlarged perspective view of a radioisotope generator of the radioisotope eluting system of FIGURE 1.

FIGURE 6 is an enlarged perspective view of a mounting cap of the auxiliary protection of the radioisotope eluting system of FIGURE 1.

FIGURE 7 is a front elevational view of the cover of the auxiliary protection assembly of FIGURE 6.

FIGURE 8 is a top plan view of the cover of the auxiliary protection assembly of FIGURE 6.

FIGURE 9 is a bottom plan view of the cover of the auxiliary protection assembly of FIGURE 6.

FIGURE 10 is a cross-sectional view of the cover of the auxiliary protection assembly of FIGURE 6 taken through line 10-10 in FIGURE 8.

FIGURE 11 is a cross-sectional view of the cover of the auxiliary protection assembly of FIGURE 6 taken through line 11-11 in FIGURE 8.

FIGURE 12 is a perspective view of the radioisotope generator in a configuration not in use that includes a lid cover.

FIGURE 13 is similar to FIGURE 12, but with the cover cap removed from the cover of the radioisotope generator.

FIGURE 14 is a perspective view of the Elution column assembly removed from a housing of the radioisotope generator.

FIGURE 15 is similar to FIGURE 14, but with column protection of the elution column assembly removed therefrom.

FIGURE 16 is similar to FIGURE 15, but with a conduit protection of the elution column assembly removed therefrom.

FIGURE 17 is similar to FIGURE 16, but with a U-shaped support of the elution column assembly removed therefrom.

FIGURE 18 is a partial perspective view of the elution system, including eluent protection and a sterile vial holder in the cover of the auxiliary protection.

FIGURE 19 is similar to FIGURE 18, but with the eluent protection removed from it.

FIGURE 20 is a top view, enlarged in perspective of the eluent protection.

FIGURE 21 is an enlarged, perspective, background view of the eluent protection.

FIGURE 22 is a perspective view with the separate portions of a second embodiment of an elution tool, including a dispensing lid removed from a body of the elution tool.

FIGURE 23 is similar to FIGURE 22, but with a storage cover removed from the body of the elution tool.

FIGURE 24 is a perspective view of the second embodiment of the elution tool including the dispensing lid, with a lid of the elution tool in an open position.

FIGURE 25 is a perspective view of the second embodiment of the elution tool including the dispensing lid, with the lid of the elution tool in an unlocked, closed position.

FIGURE 26 is a top plan view of the second embodiment of the elution tool including the dispensing lid, with the lid of the elution tool in an unlocked, closed position.

FIGURE 27 is a perspective view of the second embodiment of the elution tool including the dispensing lid, with the lid of the elution tool in a locked, closed position.

FIGURE 28 is a top plan view of the second embodiment of the elution tool including the dispensing lid, with the cap of the elution tool in a locked, closed position.

FIGURE 29 is a perspective bottom view of the second mode of the elution tool that includes the dispensing lid, with a lid dispensing the dispensing lid in a closed position.

FIGURE 30 is a bottom plan view of the second embodiment of the elution tool including the dispensing lid, with a lid dispensing the dispensing lid in a closed position.

FIGURE 31 is a perspective bottom view of the second embodiment of the elution tool including the dispensing lid, with a lid dispensing the dispensing lid in an open position.

FIGURE 32 is a bottom plan view of the second embodiment of the elution tool including the dispensing lid, with a lid dispensing the dispensing lid in an open position.

FIGURE 33 is a sectional view of the elution tool taken through line 33-33 in FIGURE 28.

FIGURE 34 is a perspective view of the sterile vial holder in FIGURE 18.

FIGURE 35 is a perspective view with the separate portions of the sterile vial holder.

FIGURE 36 is a sectional view of the sterile vial holder with the parts separated.

FIGURE 37 is a top plan view of a body of the sterile vial holder.

FIGURE 38 is a perspective view of a recovery tool.

FIGURE 39 is a sectional view of the recovery tool.

DETAILED DESCRIPTION OF THE INVENTION With reference to FIGS. 1A-4, one embodiment of a radioisotope eluting system 10 includes a radioisotope generator 12 (FIGURES 3 and 4), which can be received removably in a mounting of auxiliary protection 14. As an elution tool 16, which houses an elution vial 17 (in general terms, a container) and an eluent vial 18 (generally a container), can be connected in a fluid manner to the elution tool 16. radioisotope generator 12. In this document, "fluidly connectable" refers to the ability of the first component and a second component to be connected (either directly or indirectly) or interconnected in such a way that a liquid (e.g. eluate, eluent) can flow between them in a substantially confined flow path. The mounting of the auxiliary protection 14 includes a radiation protection body 20 which defines a cavity 22 in which the generator 12 can be received in a removable manner and a radiation protection cap 24 which can be placed on the body 20. towards an upper part of same to substantially enclose the cavity 22 defined in the body 20. In general, the radiation protection cap 24 facilitates the proper alignment of the eluent vial 18 with the radioisotope generator 12 when the eluent vial is fluidly connected to the radioisotope generator. A further description of the radiation protection cap 24 is set forth in detail below.

The elution tool 16 illustrated in FIGS. 1-11 may be of any suitable configuration (eg, size, shape, design), as is known to a person having ordinary field experience and may include one or more protective materials. against adequate radiation, such as depleted uranium, tungsten, plastic impregnated with tungsten or lead. A second embodiment of the elution tool is illustrated in FIGS. 22-33 and is described in detail below. The illustrated elution vial 17 is a generally cylindrical container, made of glass or other material (eg, plastic), which includes a septum 17a secured to an upper portion thereof by a metal ring or lid 17b, as is known generally in the field. The elution vial 17 can be a different type of container that can be suitably connected to a radioisotope generator and / or can have a shape different from the generally cylindrical shape. In a embodiment, the interior of the elution vial 17 is evacuated at least partially such that the elution vial has a reduced internal pressure (i.e., at least a partial vacuum). The eluent vial 18, like the eluting vial 17, may be a generally cylindrical package, which includes a septum (not shown) secured to an upper portion thereof by a metal ring or lid (which is not shown), as is generally known in the field. The eluent vial 18 can be a different type of container that can be properly connected to a radioisotope generator and / or can have a shape different from the generally cylindrical shape. The vial of eluent 18 is filled with an eluent fluid, such as saline. In one embodiment, the volume of the eluent fluid is less than the volume of the elution vial 17. In another embodiment, the interior volume of the eluent vial 18 is smaller than the interior volume of the elution vial 17. For example, the vial of eluent 18 can have an internal volume of about 26 milliliters and the inner volume of elution vial 17 can be about 36 milliliters. The elution vial 17 and / or the eluent vial 18 can be of other configurations without departing from the scope of the present disclosure.

With reference to FIGURES 3-5, the radioisotope generator 12 includes: a housing 26; a montage of Elution column 28 (FIGURE 3) disposed within the housing; and inlet and outlet connectors 30, 32, respectively, in fluid communication with the elution column assembly 28; and a hood or cover 38 secured to the housing. The generator housing 26 is generally cylindrical and defines an axially extending cavity in which the elution column assembly 28 is received. The housing cover 38 can be snapped into the housing 26 or secured thereto from any other appropriate way. The housing cover 38 has a low relief portion 40 extending downwardly from an upper surface of the cover. The lid 38 also has a generally U-shaped channel 42 extending downwardly from the top surface and through a side wall of the lid to the low relief portion 40. As explained in more detail below, the portion in under relief 40 and channel 42 together constitute an alignment structure, more specifically a female alignment structure, to facilitate proper alignment of the radiation shield 24 on generator 12. Generator housing 26 and cover 38 they can be made of plastic (such as by molding) or of another suitable material, preferably light. On the other hand, the generator housing 26 itself can be free of lead, tungsten, plastic impregnated with tungsten, depleted uranium or other radiation protection material, in such a way that the housing provides protection against small or only nominal radiation.

The generator 12 includes a handle of the generator 44 rotatably secured to the lid 38. The handle 44 is rotatable between a stored position, in which the handle is in a plane substantially transverse to the axis Al of the housing 26 (FIGURE 3) and below the upper surface of the lid 38, and a transport position, in which the handle is in a plane substantially parallel to the axis of the housing and above the upper surface of the lid. The handle of the generator 44 allows a radiopharmacist or technician to lift the generator 12 for the placement of the generator in the assembly of the auxiliary protection 14 and remove the generator from the auxiliary protection assembly. The handle of the generator 44 may be formed of plastic or any other suitable material and may be rotatably connected to the generator housing 26 via pivot connectors 46 (FIGURE 5) or in any other suitable connection manner.

With reference to FIGURE 3, the inlet and outlet connectors 30, 32 extend upwardly from the elution column assembly 28 and through the respective inlet opening 50 and outlet opening 52 in a bottom surface 53 of the low relief portion 40 of the generator cover 38 such that the respective terminal ends or tips 30a, 32a of the inlet and outlet connectors are disposed within the low relief portion. In the illustrated embodiment, the inlet and outlet connectors 30, 32 respectively include inlet and outlet needles or needles 30, 32 for piercing respective septa 17a of the elution vial 17 and the eluent vial 18, although it is contemplated that the connectors may be of other configurations / types. In addition to the inlet and outlet connectors 30, 32, a vent needle 54, in fluid communication with the atmosphere, extends through the bottom surface 53 of the low relief portion 40 of the lid 38. The needle Ventilation 54 is adjacent the inlet connector 30 and extends through the same inlet opening 50 in the generator cover 38. In the illustrated embodiment, the ventilation needle 54 includes a needle having a terminal end or tip 54a disposed within the low relief portion 40 of the generator cover 38. The vent needle 54 pierces the septum 17a of the eluent vial 18, like the inlet needle 30, to vent the eluent 18 vial to the atmosphere.

As shown in FIGS. 12-13, in a configuration not in use with the generator - such as during shipment - the generator 12 may include needle covers 55a, 55b and a lid cover 56. In the illustrated embodiment, the needle covers include an inlet / vent needle cover 55a removably secured directly to the inlet needle 30 and the vent needle 54, and an outlet needle cover 55b removably secured directly to the outlet needle 32. The needle covers 55a, 55b protect the respective needles 30, 32, 54 and prevent contaminants from entering the elution column assembly 28 by way of the needles. The illustrated needle covers 55a, 55b are one-piece, non-hollow, solid members that are made of a suitable material (e.g., silicone) that is pierceable by needles 30, 32, 54. Prior to operating the elution system 10, a technician can remove the needle covers 55a, 55b using forceps or other suitable instrument. It is understood that the elution system 10 may not include the needle covers 55a, 55b or the needle covers may be of other configurations without departing from the scope of the present invention.

Referring still to FIGS. 12-13, the lid cover 56 can be removably inserted in the low relief portion 40 of the generator cover 38 to cover and protect the inlet, outlet and vent needles 30, 32, 54, respectively. The lid cover 56 has an upper surface 56a that is disposed on and covers the needles 30, 32, 54 when the cover cover is secured to the generator 12 and a side wall 56b that is downwardly dependent on the upper surface frictionally engaging the side wall of the low relief portion 40 in such a manner that the lid cover is removably retained in the low relief portion by a friction-adjusted connection. The lid cover 56 has two finger holes 57 in the upper surface 56a thereof and a thumb hole 58 in the upper surface and the side wall 56b thereof. A technician can hold and remove the cover cap 56 using one hand by inserting one or more of his fingers into each of the finger holes 57 and inserting his thumb into the thumbhole 58 and then lifting the cover cover up and away from the low relief portion 40. It is understood that a cover cover has other configurations and / or can be removably secured to the generator 12 in other ways without departing from the scope of the present invention. It is also understood that the elution system 10 may not include a lid cover without departing from the scope of the present invention.

With reference to FIGS. 14-17, one embodiment of the elution column assembly 28 is shown in detail. As shown in FIGS. 16 and 17, an inlet conduit 59 extends from the inlet connector 30 and within an upper portion 60a of an elution column 60 for fluidly connecting the input connector to the elution column. The outlet conduit 61 extends from a bottom 60b of the elution column 60 to the outlet connector 32 to fluidly connect the elution column to the outlet connector. The inlet and outlet conduits 59, 61, respectively, can be made of a suitable material, such as Inconel 625MR. The elution column 60 may include a source of radioactive material therein (eg, molybdenum-99, adsorbed on the surfaces of alumina beads or a resin exchange column). In the illustrated embodiment, the filter 62 (eg, a conventional 0.2 micron filter) is fluidly connected to, and in line with, the outlet conduit 61. The filling orifice needle 63 is fluidly connected to conduit 64, which in turn fluidly connects to the elution column 60 for loading the product (typically, only the fill hole needle is accessed during loading and the technician has no access). A cover 63a, similar to the needle covers 55a, 55b described above, removably attaches to the needle 63. A ventilation duct 65 (FIGURE 17) fluidly connects the ventilation needle 54 to the atmosphere. Ventilation duct 65 has a terminal end on which an air filter 66 is secured.

As shown in FIGS. 14-16, a generally rigid U-shaped support 67, which can be formed of plastic or other suitable generally rigid material, provides structural support for the inlet and outlet needles 30, 32, Ventilation needle 54 and the filling orifice needle 63 and portions of the respective conduits 59, 61, 64, 65. As shown in FIGURES 14 and 15, the elution column assembly 28 also includes a conduit protection 68. and a column guard 69. The conduit guard 68 covers the respective conduits 59, 61, 64, 65, or portions thereof, of the adjacent inlet, outlet and vent needles 30, 32, 54, respectively, adjacent to each other. the upper part 60a of the elution column 60b. The conduit protection 68 also covers the filling orifice needle 63 and the exit filter 62. The conduit protection 68 defines internal passages for receiving and covering the respective components, while leaving the inlet, outlet and vent needles exposed. , 32, 54 and the air filter 66. The conduit protection 68 may be a two-piece construction and may include (for example, it may be made of or may have in its construction) lead, tungsten, plastic impregnated with tungsten, Depleted uranium and / or other suitable protective material against radiation. With reference to FIGURES 14 and 15, column protection 69 defines a camera (which not shown) to receive the elution column 60 and the lower portion 70 of the conduit protection 68 therein. The column protection 64 may be a one piece construction and may include (for example, it may be made of or may have in its construction) lead, tungsten, plastic impregnated with tungsten, depleted uranium and / or other radiation protective material. suitable.

Referring again to FIGURE 1, the mounting body of the illustrated auxiliary guard 20 includes an upper ring 72, a base 73 and a plurality of step-like or generally-layered modular rings 74, which are arranged one above the other between the base 73 and the upper ring 72. Substantially all or part of the mounting body of the illustrated auxiliary protection 20 can be made from one or more suitable radiation protective materials, such as depleted uranium, tungsten, plastic impregnated with tungsten or lead . The modular appearance of the rings 74 may tend to improve the adjustment of the height of the mounting body of the auxiliary guard 20 and the stepped configuration may tend to contain some radiation that could otherwise escape through a linear interconnection between the modular rings. It is understood that the mounting body of the auxiliary protection 20 may be of other configurations. In one mode (FIGURE IB), a protective cover auxiliary 75 may be received on body 20. Cover 75 has a smooth outer surface to facilitate cleaning and to protect the other surface of body 20. Cover 75 may be formed of plastic (e.g., high impact polypropylene) u other material Referring now to FIGS. 6-11, the radiation protection cap 24 includes: a generally cylindrical cap body 76 having upper and lower surfaces 77, 78, respectively; an opening of the eluting tool 79; and an aperture of the eluent vial 80. In one example (of which an exemplary method of manufacture is explained in more detail below), the lid body 76 includes a radiation shield core 124 that is overmolded with a plastic material. 126, 128. As an example, the protective core against radiation 124 may include depleted uranium, tungsten, plastic impregnated with tungsten or lead. The upper and lower surfaces 77, 78, respectively, are generally flat, although generally the surfaces may not be flat.

A male alignment structure, indicated generally with the reference number 81, is provided on the lower surface 78 of the lid body 76 to facilitate proper alignment of the lid 24 in the generator 12. More specifically, the structure of The male inlay 81 has a shape that generally corresponds to the combined shape of the low relief portion 40 and the channel 42 of the generator 12 (together, this low relief portion 40 and the channel 42 constitute a structure of female alignment) so that the male alignment structure matches the generator for the purpose of aligning the opening of the eluting tool 79 with the exit needle 32 and the opening of the eluent vial 80 with the inlet needle 30 and the ventilation needle 54. As such, it can be said that the lid 24 is in harmony with the generator 12 (e.g., the cover 38 thereof) such that proper positioning of the lid 24 on top of the generator 12 results in the alignment of the openings respective 79, 80 with the corresponding needles 32, 30. The structure 81 makes possible only one position of the lid 24 in relation to the generator 12. The illustrated male alignment structure 81 includes a wall 81a projecting outwardly from the bottom surface 78 and surrounding the opening of the eluting tool 79 and the opening of the eluent vial 80. A plurality (e.g. ) of handles 82 on the upper surface 77 of the lid body 76 allows the radiopharmaceutical or technician to properly place the lid 24 on the generator 12 and remove the generator cover.

The opening of the eluting tool 79 extends through the lid body 76 of the upper surface 77 to the lower surface 78 thereof. The The opening of the elution tool 79 is dimensioned and shaped to removably receive the elution tool 16 therein. For example, in the illustrated embodiment, the opening of the eluting tool 79 has a generally circular circumference that is substantially uniform along its axis. In one embodiment, the opening of the eluting tool 79 has a diameter slightly larger than an outer diameter of the eluting tool 16 such that the opening effectively aligned the septum (which is not shown) of the elution vial. 17 (FIGURE 4) with the exit needle 32 as the elution tool is inserted into the opening. For example, the opening of the elution tool 79 may have a diameter that is from about 0.25 mm (0.01 inch) to about 1.0 mm (0.04 inch) larger than the outside diameter of the elution tool 16. In one embodiment, the opening of the eluting tool 79 may have a diameter of about 46 mm (1.8 inches) to about 48 mm (1.9 inches), although it may alternatively have a diameter that is outside this range. Other shapes and dimensions of the opening of the elution tool 79 may be appropriate; however, there is a tendency to prefer that the shape and dimension of the opening of the elution tool 79 be at least complementary in General to the shape and dimension of the elution tool 16 that is used with the radiation shield 24 to reduce the likelihood of misalignment between the elution vial 17 and the exit needle 32.

As shown in FIGURES 9 and 10, the opening of the eluent vial 80 is set apart and separated from the opening of the eluting tool 79 and sized and shaped to removably receive the eluent vial 18 (FIGURE 2) , such as a vial containing saline or other eluents. In the illustrated embodiment (FIGURE 10), the opening of the eluent vial 80 has a lower end 86 on the lower surface 78 of the lid body 76 and an upper end 88 intermediate the upper and lower surfaces 77., 78, respectively. In one example, the opening of the eluent vial 80 may have a diameter of about 34.0 mm (1.34 inches) to about 34.5 mm (1.36 inches), although it may alternatively have a diameter that falls outside this range. As with the opening of the elution tool 79, other shapes and dimensions of the eluent vial opening 80 may be appropriate; however, there is a tendency to prefer that the shape and dimension of the opening of the eluent vial 80 be at least generally complementary to the shape and size of the eluent vial 18 that is used with the radiation protection cap. for reduce the likelihood of misalignment between the eluent vial 18 and the inlet needle 30 and the ventilation needle 54.

With reference to FIGURES 2, 6, 8 and 11, the illustrated cap 24 has two finger holes 90 formed in the upper surface 77 of the cap body 76, which are diametrically opposed to each other with respect to the opening of the vial of eluent 80. The finger holes 90 are defined by respective low relief surfaces extending downward from the upper surface 77 of the cover body 76 to the opening of the eluent vial 80 and sized and shaped to allow at least two finger distal portions of a radiopharmaceutical or other appropriate technician enter the finger holes. The low relief surfaces defining the illustrated finger holes 90 are curved and generally have the shape of a bowl medium in such a way that the low relief surfaces lead the fingers of the radiopharmaceutical or technician towards the opening of the eluent vial 80. It is understood that in other embodiments the lid 24 may have an individual finger gap, such as a finger hole that completely or partially surrounds the opening of the eluent vial 80, or more than two finger holes. With reference to FIGURE 8, each of the illustrated finger holes 90 has an upper edge 92 adjacent the upper surface 77 of the body of the lid 76 and a lower edge 93 which is coextensive with a portion of the upper end 88 of the opening of the eluent vial 80.

With reference to FIGURE 11, the cover 24 of the auxiliary protection assembly 14 includes a first and a second alignment fin 100, each designated generally with the reference numeral 100, which extend upwardly from the adjacent upper end 88 of FIG. the opening of the eluent vial 80 within the finger holes 90. Each of the first and second fins 100 have opposite sides 104, an upper portion 106, and an inner surface 108 that extends partially around a circumference of the upper end. 88 of the opening of the eluent vial 80. In the illustrated embodiment, the upper portion 106 of each of the fins 100 is disposed above the upper surface 77 of the lid body 76 (as best seen in FIGS. 7 and 7). 10) and the inner surface 108 of each of the fins 100 is generally arched, although it is understood that the fins 100 may be of other relative shapes and dimensions. Together, the inner surfaces 108 of the fins 100 and the opening of the eluent vial 80 define a passageway of the vial 107 that extends from the upper portions 106 of the fins 100 through the lower surface 78 of the lid body 76.

The fins 100 preferably make it possible to align the septum of the eluent vial with the needle of inlet 30 and vent needle 54 as the eluent vial 18 is inserted into the vial passageway 107. As such, the fins 100 preferably make it less likely that the inlet needle 30 or the vent needle 54 make contact with the metal ring or other hard part of the vial and the needle is damaged. In one example, the inner surface 108 of each fin 100 can extend at least 45 degrees and less than 180 degrees around the circumference of the upper end 88 of the eluent vial opening 80. In other examples, the interior surface 108 of each fin 100 can extend at least 60 degrees or at least 90 degrees and less than 180 degrees around the circumference of the upper end 88 of the eluent vial opening 80. Other configurations of the fins 100 do not depart from the scope of the present description.

To facilitate the attachment of the eluent vial 18 during at least one of the vial insertion in the vial passage 107 and the removal of the vial from the vial passage, the respective adjacent sides 104 of the first and second fin 100 are separated each other around the opening of the eluent vial 80 to define openings or a first and a second finger channel, each indicated with the reference number 112 (FIGURES 6 and 10), which leads from the finger holes 90 to the passage from the little bottle In the illustrated embodiment, the finger channels 112 are aligned diametrically, in relation to the opening of the vial 80, with the finger holes 90 and the respective sides 104 of the fins 100 extend into the associated finger holes 90. Each of the first and second finger channels 112 is dimensioned and is formed to allow at least the distal portion of one of the two fingers to enter the corresponding finger channel of the associated finger slot 90. For example, a minimum width of each of the finger channels 112 (i.e. the distance between the respective adjacent sides 104 of the first and second fins 100) can measure from about 19 mm (0.75 inches) to about 21 mm (0.83 inches) and more specifically, from about 19.0 mm (0.748 inches) to about 19.6 mm (0.776 inches), although the minimum width of each finger channel may be outside this range. In this way the finger channels 112 allow the radiopharmacist or technician to hold the eluent vial 18, such as by the use of his thumb and index finger, during at least one of the vial insertion in a passage of the vial. 107 and the removal of the vial from the vial.

In the illustrated embodiment (FIGURES 8, 10 and 11), a diameter of a portion of the passageway of the vial 107 defined by the interior surfaces 108 of the fins 100 is tapered from the upper portions 106 of the fins toward the opening of the eluent vial 80. Tapering of the interior surfaces 108 of the fins 100 facilitates the molding of the fins when the lid 24 is overmolded in one example, as described below. Although this diameter of the passageway of the vial 107, defined by the interior surfaces 108, is tapered along the length of the passage, a plurality of alignment reinforcements 114 are provided on the interior surfaces to define an effective interior diameter of the passageway of the vial. that is substantially uniform throughout the length of the passage. The reinforcements 114 are separated from each other between the sides 104 of the fins and extend longitudinally along the respective fins 100. The fins 100 project inwardly, generally toward a centerline of the passageway 107, such that each reinforcement 114 has a guide surface, terminal 115 (FIGURE 11) that is generally oriented toward the center line of the passage. Each guide surface 115 is evenly spaced from the centerline of the passageway of the vial 107 over its entire length. In other words, the guide surface 115 of each reinforcement 114 is not tapered or widened with respect to the axis of the passageway of the vial 107. Through this configuration, the guide surfaces 115 effectively align the elution vial 18 with the needle. of inlet 30 and vent needle 54 although inner surfaces 108 of fins 100 are tapering The reinforcements 114 have depths projecting into the passageway of the vial 107 relative to the respective inner surfaces 108. Because the diameter of the passageway of the vial 107 defined by the interior surfaces 108 of the fins 100 is tapered, nevertheless The guide surfaces 115 are not tapered or widened in relation to the center line of the passage of the vial, the depths of the reinforcements relative to the respective inner surfaces 108 are tapered towards the opening of the eluent vial 80. The fins 100 may not include the reinforcements 114 without departing from the scope of the present disclosure.

As illustrated in FIGURE 3, a bottom 116 of the eluent vial 18 is located slightly below or in the upper portions 106 of the fins 100 when the eluent vial is received in the passageway of the vial 107 and connected fluidly to the vial. the entry needle 30. The nicks 118 in the upper portions 106 of the fins 100 allow the radiopharmacist or technician to observe the eluent vial 18 in the passage without having to place his head above the upper surface 77 of the lid 24.

In one example, the cover of the auxiliary protection 24 can be formed by means of a two-step overmolding process. In this process, a protective core against radiation 124 (FIGURE 10) - which may include a material Proper radiation shielding such as depleted uranium, tungsten, plastic impregnated with tungsten or lead - is provided. The core 124 may generally have a disc shape, having a first and a second opening, which will form the elution tool and the eluent vial openings 79, 80, respectively and the recesses, which will form the finger holes 90. A first molded part is molded with a first thermoplastic material 126 to form the bottom surface 78, the male alignment structure 81 and the side wall of the body 76 and at least lower portions of the opening of the elution tool 79 and the opening of the eluent vial 80. Then, the core 124 is placed inside the first molded part. Finally, this assembly is overmolded with a second thermoplastic material 128 to form the upper surface 77, the handles 82, the finger holes 90, the fins 100 and an upper portion of at least the opening of the eluting tool 79. first thermoplastic material and second thermoplastic material 126, 128, respectively, may include polypropylene and polycarbonate, or other material, and the first thermoplastic material and the second thermoplastic material may be of the same material. Other methods can be used to make the cover of auxiliary protection 24.

With reference to FIGS. 18-21, an eluent protection 136 of the elution system 10 can be placed on the eluent vial 18 when the vial is received in the eluent vial 80 opening in the lid 24 and can be connected fluidly to the generator 12 to prevent exposure of the radiopharmaceutical or technician to radiation when the eluent is fluidly connected to the generator (eg, during and after an elution process). The eluent protection 136 has an upper part 138, an opposing bottom 140 and a cavity 142 extending from the bottom to the top. A pair of protective flaps 144 in the bottom 140 of the eluent protection 136 partially surround the cavity 142. The protective fins 144 are sized and configured to fit comfortably within the finger holes 90 in the lid 24 so that the portions The upper fins 106 of the alignment fins 100 are received in the cavity 142 of the eluent guard 136 and the protective fins 144 opposite the sides 104 of the alignment fins and the finger channels or openings 112 between the sides of the fins of the fins. alignment. As such, substantially all of the eluent vial 18 is surrounded by the radiation protective material of either the lid 24 or the eluent protection 136. More specifically, when the eluent protection 136 is placed in the lid 24, substantially the entire vial of eluent 18 is surrounded by a suitable radiation protective material, such as depleted uranium, tungsten, plastic impregnated with tungsten or lead.

In one example, the eluent protection 136 can be formed by means of a two-step overmold process. In this process, a radiation protective core 124, which may include a suitable radiation protective material such as depleted uranium, tungsten, plastic impregnated with tungsten or lead - is provided. The core has substantially the same shape as the eluent protection in finished form, including a pair of protective fins and a cavity. A first molded part is molded with a first thermoplastic material to form the upper part 138. Then, the core is placed inside the first molded part. Finally, this assembly is overmolded with a second thermoplastic material to form the bottom 140, the protective fins 144 and the cavity 142. The first thermoplastic material and the second thermoplastic material, respectively, can include polypropylene and polycarbonate, or other material, and the The first thermoplastic material and the second thermoplastic material can be of the same material. Other methods can be used to fabricate the eluent protection 136.

With reference to FIGS. 22-33, a second embodiment of an elution tool 150 is generally indicated with the reference number 150. This elution tool 150 includes a body, indicated generally with reference number 152, having an upper part 154 and an opposing bottom 156; and a cap, indicated generally with the reference number 158, hingedly secured to the upper body portion of the elution tool. As explained in more detail below, a dispensing lid 160 (FIGURE 22) can be removably secured to the bottom 156 of the body of the eluting tool 152 to configure the elution tool in a dispensing tool configuration and a storage lid. 162 (FIGURE 23) can be removably secured to the body bottom of the elution tool to configure the elution tool in a storage tool configuration. In general, the dispensing lid 160 and the storage lid 162 can be interchangeably secured to the body of the eluting tool 152. In the illustrated embodiment, neither the dispenser lid 160 nor the storage lid 162 is secured to the body of the dispenser. elution tool 152 when the elution tool 150 is inserted into the auxiliary protection and the elution vial 17 in the elution tool is fluidly connected to the generator 12.

The body of the eluting tool 152 is dimensioned and formed to be slidably received in the opening of the elution tool 79 in the cover of the elution tool. the auxiliary shield 24. The body 152 has an upper longitudinal portion 163 having a first outer diameter defining an annular detent surface 164 for preventing the upper body portion 154 from entering the opening of the elution tool 79 in the cap of the auxiliary shield 24. A lower longitudinal portion 166 of the body 152, having a second outer diameter that is smaller than the first outer diameter, can be received in the dispensing and shielding covers 160, 162, respectively, as explained with greater detail later. A longitudinal, intermediate portion 168 of the body 152, having an outer diameter that is smaller than the first outer diameter and larger than the second outer diameter OD2, is dimensioned and formed to be slidably received in the opening of the tool Elution 79. The body of elution tool 152 may include (for example, it may be made of or may have in its construction) lead, tungsten, plastic impregnated with tungsten, depleted uranium and / or other suitable protective material against radiation .

The body of the eluting tool 152 is configured to receive the elution vial 17 therein. In particular, the body of the eluting tool 152 has a vial chamber 170 (Figure 33) defined therein that extends from an aperture 172 in the upper part 154. from the body of the elution tool to an opposite access opening 174 at the bottom thereof. The upper aperture 172 is sized and configured to allow the elution vial 17 to be inserted into and removed from the vial chamber 170 and the vial chamber has a dimension and shape that generally corresponds to the size and shape of the vial of elution in such a way that the elution vial fits generally comfortably inside the chamber. The bottom 156 of the body of the eluting tool 152 defines an annular inner surface 178 surrounding the access opening 174. When the eluting vial 17 is received in the vial chamber 170, the metal ring 17b of the vial contacts the the inner surface 176 so that the septum 17a is aligned with the access opening 174. Accordingly, when the eluting tool 150 is inserted into the opening of the eluting tool 79 in the lid 24, the exit needle 32 enters to the access opening 174 and pierce the septum 17a.

The lid of the eluting tool 158 is hingedly secured to the body of the eluting tool 152 and can be configured between an open or exposed position (FIGURE 24), in which the upper opening 172 is exposed and the eluting vial 17 can be inserted into and removed from the vial chamber 170, and a closed or occluded position (FIGURES 25-28), in which the opening The top is occluded and the elution vial is retained in the vial. The lid of the eluting tool 158 includes a generally flat or disc-shaped lid body 178 which can be received in a recess of the lid 180 defined in the upper part 154 of the body of the eluting tool 152 when the lid It is in the closed position. The lid body 178 has a lower face 178a that sits on an inner annular flange or lid seat 182 of the lid recess 180 and an upper face 178b that is substantially coplanar with the upper part 154 of the body of the eluting tool 152 when the lid 158 is in a closed position. The upper face 178b of the lid body 178 has a plurality of holding grooves 179 formed therein to provide a holding region for the radiopharmaceutical or technician when the lid is opened and closed, as explained in more detail below. For reasons which are apparent from the following description, the lid of the eluting tool 158 has a generally circular periphery and the recess of the lid 180 and the seat of the lid 182 have generally oblong peripheries. On the other hand, the lid of the elution tool 158 is sized and formed to allow the movement of the lid along the main axis of the lid gap 180 when the lid rests on the seat of the lid 182. The body of the The lid of the elution tool 178 may include (for example, lead, tungsten, plastic impregnated with tungsten, depleted uranium and / or other suitable protective material against radiation may be made of or may have in its construction).

With reference to FIGS. 22-28, the elution tool illustrated 150 includes an articulated lid connection, generally indicated with the reference numeral 186, and a latch mechanism, indicated generally with the reference numeral 188, for blocking in a manner releasable lid 158 in the closed position. The hinged lid connection 186 includes a hinge connector 190 extending radially or laterally outwardly from the periphery of the lid body 178 and a hinge pin 192, adjacent the periphery of the upper part 154 of the body of the hinge. elution tool 152, to which the articulation connector is attached. The hinge connector 190 defines a slot 194 in which the hinge bolt 192 is received to allow both the rotation of the hinge connector (and the cap 158) around the hinge pin, as well as the linear, transverse, limited movement of the connector of articulation (and the cover) in relation to the articulation bolt. The latch mechanism 188 includes a latch member 194 extending radially or laterally outwardly from the periphery of the body of the latch. cap 178, generally diametrically opposite the articulation connector 190. The engagement member 194 includes a pin 196 that can be slidably received in a latching notch 198 adjacent the periphery of the upper part 154 of the tool body. elution 152. A retainer 200 (eg, a ball retainer) in the body of the eluting tool 152 extends into the latching notch 198 and slidably engages the latching member 194 (eg, a lower side of the engagement member) as the peg 196 slides into the latching notch to prevent the latch member from being inadvertently withdrawn (eg, slid back out) from the latch notch.

To lock the lid 158 in the closed position (FIGURES 27 and 28), the radiopharmaceutical or technician can rotate the lid around the hinge pin 192 to the closed position such that the body of the lid 178 rests on the lid seat 182 of the body of the eluting tool 152. Once seated, the slot 194 in the articulation connector 190 allows the radiopharmaceutical or technician to move the cap 158 linearly towards the latching notch 198, whereby the tang 196 can be slid within the latching notch 198. For example, while the elution tool 150 is retained using one hand, the radiopharmacist or technician can make contact with the upper face 178b of the lid body 178 (more specifically, the region defined by the holding grooves 179) with its thumb to rotate the lid 158 to its closed position and then linearly slide the lid towards the engaging groove 198 As the engaging member 194 slides over the ball retainer 200, the ball retainer deflects and pushes against the engaging member. Once the tang 196 is received in the latching notch 198, the latch 158 is releasably locked in the closed position. The cap 158 can be unblocked (FIGURES 25 and 26) by the radiopharmaceutical or technician using his thumb to slide the cap away from the latching notch 198, against the pushing force of the ball retainer, so that the spike 196 is withdrawal from latch notch 198. Once unlocked, lid 158 can be rotated to the open position. It is understood that the lid 158 can be releasably locked in the closed position in other ways and other ways to retain the eluting vial 17 in the eluting tool 150 do not depart from the scope of the present disclosure.

As described above, the dispensing lid 160 can be removably secured to the lower longitudinal portion 168 of the body of the eluting tool 152, as shown in FIGURE 22, to configure the elution tool in the dispensing configuration. In the dispensing configuration, the elution tool 150 can be used as a dispensing tool, whereby the radiopharmacist or technician can retain the elution tool and withdraw a quantity of radiopharmaceutical from the elution vial 17 housed in the elution tool without removing the dispensing lid 160. The dispensing lid 160 includes a body 204 (e.g., a generally cylindrical body) having an upper portion 206 and a bottom 208. The body of the dispensing cap 204 defines a receptacle 210 extending from the upper 206 towards the bottom 208 thereof which is dimensioned and shaped to receive the lower longitudinal portion 166 of the body of the eluting tool 152. The receptacle 210 has an open upper end to allow insertion of the lower longitudinal portion 166 of the body of the elution tool 152 in the receptacle and an access opening 212 in the bottom 20 8 of the body of the dispensing lid 204 that can be aligned with the access opening 174 in the body of the eluting tool 152 to provide access to the septum 17b of the eluting vial 17 in the chamber 170 of the body of the eluting tool 152 .

With reference to FIGURE 22, the dispensing lid 160 includes a plurality of magnetic couplers 214 attached to the body of the dispensing lid 204 and surrounding the receptacle 210 to releasably secure the dispensing cap to the body of the eluting tool 152 when the lower longitudinal portion 166 of the body of the elution tool is received in the receptacle. The magnetic couplers 214 are magnetically attracted to an annular coupler surface 216 of the body of the eluting tool 152 which is in an opposite relationship with the magnetic couplers when the lower longitudinal portion 166 of the elution tool body is received in the receptacle 210 of the dispensing lid 160. In another mode, the body of the eluting tool 152 can include magnetic couplers that are magnetically attracted to the magnetic couplers (or some other component or structure) of the body of the dispensing lid 204. The dispensing lid 160 also includes a locking pin 218 which is extends longitudinally outward from the upper portion 206 of the body of the dispensing cap 204. The locking pin 218 can be aligned with and can be received in a locking cavity 220 in the annular engaging surface 216 of the body of the eluting tool 152. to prevent the dispensing lid 160 from rotating around the body of the elution tool. In an example of securing the dispensing lid 160 to the body of the eluting tool 152, the radiopharmacist or technician can insert the bottom longitudinal portion 166 of elution tool body 152 within receptacle 210 of dispensing lid 160 and then can rotate the dispensing lid around the body of the eluting tool (or vice versa) until the locking pin 218 is aligned with and between the locking cavity 220. The dispensing lid 160 can be removably secured to the body of the eluting tool 152 in other ways.

The dispensing lid 160 includes a dispensing lid 222 rotatably secured to the bottom 208 of the dispensing lid body 204 by a pivot 223 (e.g., a pivot screw) for selectively opening and closing the access opening 212 of the receptacle 210 and for provide adequate protection against radiation when the elution vial 17 is received in the eluting tool 150. More specifically, the dispensing cap 222 is received in a recess 224 formed in the bottom 208 of the body of the dispensing lid 204 and is rotatable about an axis of rotation defined by the pivot 223 which is generally parallel to the longitudinal axis of the eluting tool 150. The dispensing cap 222 is rotatable between a non-dispensing position (FIGURES 29 and 30), in which the dispensing cap is aligns with and is opposite (ie, covers) the access opening 212 of the receptacle 210 and a dispensing position (FIGURES 30 and 31), in which the dispensing cap is incorrectly aligned at least partially with the access opening (i.e., the access opening is at least partially exposed) to allow access to the septum 17b of the elution vial 17 A detent 226 (eg, a ball retainer) in the bottom 208 of the body of the dispensing lid 204 releasably locks the dispensing lid 222 in the non-dispensing position. On the other hand, when the dispensing lid 222 is moved to the dispensing position, the retainer 226 can be removably received in one of a plurality of slots (eg, three slots, which are not shown) formed on a lower side of the dispensing lid. Accordingly, the dispensing lid 222 can be releasably locked in a selected position of a plurality of dispensing positions, each providing a different degree to which the lid is opened.

To place the dispensing cap 222 in the dispensing position and to provide access to the elution vial 17 in the eluting tool 150 when the dispensing cap 160 is secured to the elution tool, a radiopharmaceutical or technician can retain the elution tool in a hand and use your thumb to hold the dispensing cap and spin (ie rotate) the dispensing cap around the pivot 223 and away of the access opening 212 in the dispensing lid. As the radiopharmaceutical or technician rotates the dispensing lid 222 is opened, the retainer 226 is biased elastically to allow the dispensing cap to slide over the retainer. The radiopharmaceutical or technician may continue to rotate the dispensing cap 222 until the cap is in a selected dispensing position and the retainer 226 enters one of the slots (which are not shown) on the underside of the cap. With the dispensing cap 222 in a selected dispensing position, the radiopharmaceutical in the elution vial 17 is accessible to the radiopharmaceutical or technician, because the radiopharmaceutical or technician can insert a syringe dispensing needle (which is not shown) to through the access openings 212, 174 in the respective dispensing lid 160 and the body of the eluting tool 150 and in the eluting vial 17, when piercing the septum 17b, to remove a desired amount of radiopharmaceutical from the elution vial. After removing the desired amount of radiopharmaceutical, the radiopharmaceutical or technician can place the dispensing cap 222 in the non-dispensing position by rotating or turning the cap toward the access opening 212, whereby the stopper 226 deviates as the cap it slides towards the access opening. A wall 228 that partially defines the recess 224 in the dispensing lid 160 acts as a stop to prevent that the lid slides past the access opening 212 as the lid is closed.

The dispensing cap 222 may include (for example, lead, tungsten, plastic impregnated with tungsten, depleted uranium and / or other suitable radiation protective material may be made of or may have in its construction. In contrast, the body of the dispensing lid 204 may be formed of a suitable material, such as aluminum, plastic or other lightweight material, resistant to corrosion or other material having a density less than the density of the adequate radiation protection. , such as that provided by lead, tungsten, plastic impregnated with tungsten, depleted uranium. The body of the dispensing lid 204 does not need to provide adequate radiation protection, such as that provided by lead, tungsten, plastic impregnated with tungsten, depleted uranium and / or other suitable protective material against radiation, because this protection adequate radiation is provided by the body of the elution tool 152. Accordingly, the dispensing lid 160 does not add a significant amount of weight to the elution tool 150 so that the elution tool can be used properly as a tool dispenser for the radiopharmaceutical or technical.

With reference to FIGURE 23, as discussed above the storage cover 162 can be removably secured to the body of the eluting tool 152 to configure the elution tool in the storage configuration. In the storage configuration, the storage lid 162 must be removed from the body of the eluting tool 152 for the purpose of having a radiopharmaceutical or technician remove an amount of the radiopharmaceutical from the elution vial 17. The storage lid 162 includes a body of the storage lid 232 (for example, a generally cylindrical body) having an upper part 234 and a bottom 236 and a radiation shield 238 secured to the bottom of the body of the storage lid. The storage lid body 232 defines a receptacle 240 extending from the top 234 toward the bottom 236 of the storage lid body that is dimensioned and shaped to receive the bottom longitudinal portion 166 of the body of the elution tool. 152. The receptacle 240 has an open upper end to allow insertion of the lower longitudinal portion 166 of the body of the eluting tool 152 into the receptacle. The radiation shield 238 is secured to the bottom 236 of the body of the storage cover 232 in such a way that the shield is aligned and is in a opposite relationship with the access opening 174 in the body of the eluting tool 152 when the storage lid 162 is removably secured to the eluting tool 150. In the illustrated embodiment, the radiation shield 238 is an insert press in the body of the storage lid 232. The radiation shield 238 can be secured to the body of the storage lid 232 in other ways without departing from the scope of the present disclosure.

With reference to FIGURE 23, the storage lid 162 is removably secured to the body of the eluting tool 152 in substantially the same manner as the dispensing lid 160, although the storage lid can be removably secured in other ways . More specifically, the storage cover 162 includes a plurality of magnetic couplers 244 secured to the body of the storage cover 232 and surrounding the receptacle 240. The magnetic couplers 244 are magnetically attracted to the annular engagement surface 216 of the tool body of the tool. elution 152. It is understood that the body of the eluting tool 152 can include magnetic couplers secured thereto, which are magnetically attracted to the magnetic couplers (or other component or structure) of the body of the storage lid. The cover Dispenser 160 can be removably secured to the body of elution tool 152 in other ways without departing from the scope of the present disclosure.

With reference to FIGS. 34-37, the radioisotope eluting system 10 may also include a sterile vial holder, generally indicated with the reference number 250, for a vial 252 of sterile fluid (eg, TechneStat ™) in which the exit needle 32 is stored when the elution system 10 is not in use. As explained in more detail below, after the elution process, the elution tool 150 can be removed from the opening of the eluting tool 79 in the auxiliary protection cover 24, at which time the sterile vial holder 250 is can insert into the opening of the eluting tool so that the exit needle 32 pierces a septum 252a of the sterile fluid vial. The sterile vial holder 250 includes a body, generally indicated by reference numeral 254, for holding the sterile vial 252 therein, and a lid, generally indicated by reference number 256, which can be removably secured to the vial. body. The body of the support 254 has a generally cylindrical receptacle 258 having an open top 260, a bottom 262 and a vial chamber 264 sized and shaped to receive and retain the sterile vial 252 therein. As it is shown in FIGURE 36, bottom 262 of receptacle 258 defines an access opening 266 that aligns with septum 252a of sterile vial 252 when the vial is received in chamber 264 so that exit needle 32 pierces the septum and enters into the septum. sterile vial when the holder of the sterile vial 250 is inserted into the opening of the elution tool 79.

The body of the support 254 includes a plurality of fins 268 (e.g., four fins) projecting radially outwardly of the receptacle 258 and spaced around the receptacle. The fins 268 define a diameter or transverse dimension of the receptacle 258 that is dimensioned and shaped to comfortably fit within the opening of the eluting tool 79 so that the access opening 266 (and the septum 252a) align with the needle of outlet 32 when the holder 250 is inserted into the opening of the elution tool. The body of the support 254 may be of other configurations without departing from the scope of the present disclosure.

The cover 256 of the sterile vial holder 250 can be removably secured to the body 254 by means of a rotary locking mechanism, generally indicated by reference numeral 270. The body 254 includes a female, annular, rotatable locking component 272 which receives a male rotating lock component 274 projecting outward from a bottom surface 276 of the cover 256. The female rotary lock component 272 defines grooves or notches 278 that are spaced around an inner surface 280 of the female rotary locking component to define the openings 281. The male rotary locking component 274 includes a plurality of tongues 282 that can be received in the openings 281 defined between the notches 278 of the female rotary locking component and entering the notches 278 when the cover 256 is rotated about its longitudinal axis relative to the body of the support 254. When the tabs 282 are received in the notches 278, the rotary locking mechanism inhibits relative longitudinal movement between the cover 256 and the support body 254. In the embodiment illustrated, the male rotary locking component 274 also includes a longitudinal projection 284 that enters the chamber of vial 264 of receptacle 258 and abuts the bottom of sterile vial 252 to limit or restrict the longitudinal movement of the sterile vial in the chamber. It is understood that the lid 256 can be releasably secured to the body 254 in other ways without departing from the scope of the present disclosure.

The body of the support 254 can be a one-piece component formed (eg, molded) of plastic or other material having a density less than the density of the material that provides adequate protection against radiation, such as that provided by lead, tungsten, plastic impregnated with tungsten, depleted uranium. The lid 256, on the other hand, may include a suitable radiation protective material such as depleted uranium, tungsten, plastic impregnated with tungsten or lead. In one example, the lid can be formed by means of a two step overmolding process. In this process, a protective core against radiation - which may include a protective material against adequate radiation such as depleted uranium, tungsten, plastic impregnated with tungsten or lead - is provided. A first molded part is molded with a first thermoplastic material to form the upper part 260. Then, the core is placed in the first molded part. Finally, this assembly is overmolded with a second thermoplastic material to form the bottom 262, the male rotary locking component 274 and the longitudinal projection 284. The first thermoplastic material and the second thermoplastic material, respectively, may include polypropylene and polycarbonate, or other material, and the first thermoplastic material and the second thermoplastic material can be of the same material. Other methods can be used to manufacture the cover 256.

With reference to FIGURES 38 and 39, the elution system 10 may also include a tool for recovery, generally indicated with the reference number 290, for re-applying the inlet / vent needle cover 55a and the exit needle cover 55b on the respective inlet and vent needles 30, 54 and the exit needle 32. The recovery tool 290 has a first longitudinal portion 292, which defines a cavity of the exit needle cover 294 for comfortably receiving the exit needle cover 55b therein and a second longitudinal portion 296, which defines a cover cavity. inlet / vent needle 298 for comfortably receiving the inlet / vent needle cover 55a therein. The first longitudinal portion 292 has a size and shape such that it can be received comfortably in the opening of the eluting tool 79 in the cover of the auxiliary shield 24 and the second longitudinal portion 296 has a size and shape of such which can be received comfortably in the opening of the eluent vial 80 in the cover of the auxiliary protection. The recovery tool 290 can be formed of plastic, or other suitable material, and can be molded as a single piece structure.

To re-apply the covers 55a, 55b, the radiopharmaceutical or technician inserts the covers in the respective cavities 294, 298. The covers 55a, 55b are maintained in the respective cavities 294, 298 by the Frictional adjustment coupling between the walls of the cavities and the covers. The radiopharmaceutical or technician can then insert the second longitudinal portion 296 into the opening of the eluent vial 80, whereby the inlet and vent needles 30, 54 pierce the cover 55a. Upon removal of the second longitudinal portion 296 from the eluent vial opening 80, the cover 55a remains secured to the inlet and vent needles 30, 54. The radiopharmaceutical or technician may then insert the first longitudinal portion 292 into the opening of the tool. of elution 79 to re-apply cover 55b in a similar manner. It is understood that the covers 55a, 55b can be applied again in any order without departing from the scope of the present disclosure.

In a method for using the radioisotope eluting system 10, the radiopharmaceutical or technician manually inserts the radioisotope generator 12 into the cavity 22 of the auxiliary protection body 20., the handle is folded down and the cover of the lid 56 is removed in the manner previously discussed. The cover of the auxiliary protection 24 is then manually positioned in the cavity, on top of the radioisotope generator 12. The cover 24 can be rotated to thereby couple the male alignment structure 81 on the cover with the alignment structure female (that is, the portion in low relief 40 and the U-shaped channel 42) on the cover 38 of the generator 12. With the coupling, the opening of the eluent vial 80 is disposed on and aligned vertically in general with the inlet needle 30 and the ventilation needle 54, and the opening of the eluting tool 79 is arranged on and vertically aligned vertically with the exit needle 32. Using forceps (or other tool), the radiopharmaceutical or technician removes the two covers 55a and 55b. The eluent vial 17 is manually inserted into the passage defined by the fins 100 and the opening of the eluent vial 80. The passage guides the eluent vial 17 in a substantially vertical direction, such that the longitudinal axis of the eluent vial is generally aligned with the axes of the entry needle 30 and the ventilation needle 54. More specifically, the passage guides the eluent vial 17 in such a manner that the entry needle 30 and the ventilation needle 54 pierce the septum of the vial for fluidly connecting the interior of the eluent vial with the generator 12. The radiopharmacist or technician can observe the bottom 116 of the eluent vial 18 through the nicks 118 in the respective fins 100 when the vial is received in the passageway 107 to confirm that the eluent vial 18 is completely inserted over the generator 12. Therefore the radiopharmacist or technician does not have to place his head directly above the lid 24 for confirm that needles 30, 54 actually pierced the septum of the eluent vial. For this purpose, the radiopharmacist or technician reduces any chance of exposure to the radiation of the generator 12 when he places his head on the opening of the eluent vial 18. Once confirmation is made that the vial is properly positioned, the protection of the eluent 136 can be placed on the bottom of the eluent vial in the manner set forth above.

In this method, the elution vial 17 is inserted into the elution tool 150 and the cap 158 closed in the manner discussed above. The elution tool, which does not have either the dispensing lid 160 or the storage lid 162 secured thereto, is manually inserted into the opening of the elution tool 79 in such a way that the exit needle 32 punctures the septum of the elution vial to fluidly connect the elution vial to the generator 12. The vacuum (or reduced pressure) in the elution vial 17 extracts the saline solution from the vial 18 through the radioisotope column and into the elution vial 17 After the elution vial 17 is filled with the desired amount of saline solution containing radioisotopes, the elution tool 150 can be manually removed from the lid 24, at which time the dispensing lid 160 or the storage lid 162 the body of the elution tool 152 can be secured in the manner set forth above. With the dispensing lid 160 secured to the body of the eluting tool 152, the radiopharmaceutical or technician can remove desired amounts of the radiopharmaceutical from the elution vial 17 in the manner set forth above.

With the elution tool 150 removed from the lid 24, the sterile vial holder 250 can be inserted into the opening of the eluting tool 79 so that the exit needle 32 punctures the sterile vial 252. The eluent vial now unoccupied 18 can remain in the radioisotope generator 12 until a subsequent elution for the purpose of keeping the needles 30, 54 sterile. When it is time for a subsequent elution, the eluent vial 18 can be manually removed from the lid 24, such as by the radiopharmaceutical or technician by inserting his thumb and index finger into the respective finger holes 90 and then into the respective finger channels 112 to clamp (or compress) the eluent vial. The radiopharmaceutical or technician can then lift the eluent vial 18 off the needles 30 and 54 and out of the cap 24.

When introducing the elements of the present invention or the modality (s) thereof, it is intended that the articles "a", "an", "the" and "the" mean that there is one or more of the elements. You have the intent that the terms "comprising", "including" and "having" be inclusive and mean that there may be additional elements other than the elements listed.

Since several changes could be made to the apparatus and previous methods without departing from the scope of the description, it is intended that all the matter contained in the above description and shown in the associated figures should be interpreted as illustrative and not in a sense limiting It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.

Claims

CLAIMS Having described the invention as above, the content of the following claims is claimed as property:

1. An elution tool for a radiopharmaceutical elution system, characterized in that it comprises: a body of the eluting tool having an upper part, an opposing bottom, an opening in the upper part, a vial chamber extending from the opening in the upper part towards the bottom which is sized and shaped to receive a vial elution therein through the opening in the upper part and an access opening extending through the bottom to the vial chamber, the access opening is aligned with a septum of the elution vial when the elution vial it is received in the vial chamber, wherein the body of the elution tool comprises at least one of depleted uranium, tungsten, plastic impregnated with tungsten and lead; a lid of the elution tool secured to the body of the elution tool by an articulated connection adjacent to the upper body portion of the elution tool, the lid of the elution tool is rotatable in the articulated connection and in relation to the elution tool. body of the elution tool between an occluded position, in which the elution tool cover occludes the opening in the upper part of the body of the elution tool, and an exposed position, in which the lid of the elution tool does not occlude the opening in the upper part of the elution tool body to allow the vial of elution is inserted into and removed from the vial, where the cap comprises at least one of depleted uranium, tungsten, plastic impregnated with tungsten and lead; Y a latching mechanism for selectively and releasably locking the lid in the occluded position.

2. The elution tool according to claim 1, characterized in that the articulated connection is configured to allow the transverse, linear movement of the lid in relation to the body when the lid is in the closed position.

3. The elution tool according to claim 2, characterized in that the articulated connection comprises a groove defined in one of the body and the cover and a hinge pin in the other body and cap and is received in the groove.

4. The elution tool according to claim 2, characterized in that the latching mechanism comprises a latching member on the lid and a latching notch defined in the body, wherein the latching member is configured to be received in a manner that Sliding and removable from the latching notch when moving the lid transversely in relation to the body.

5. The elution tool according to claim 4, characterized in that the latching mechanism further comprises a retainer which engages releasably with the engaging member as the engaging member enters the latching notch to prevent inadvertent removal of the latch. coupling member of the coupling notch.

6. The elution tool according to claim 1, characterized in that the articulated connection and the latching mechanism are opposite each other in relation to the lid.

7. The elution tool according to claim 1, characterized in that the body includes a seat on which the lid rests when the lid is in the closed position, wherein the seat has an oblong periphery with a main shaft and the lid has a generally circular periphery, wherein the articulated connection is configured to allow transverse, linear movement of the lid in relation to the body along the main axis of the seat when the lid is in the closed position.

8. The elution tool according to claim 1, characterized in that it also comprises a dispensing lid removably secured to the bottom of the body of the elution tool, the dispensing lid comprises a body having an access opening which is aligned with the access opening of the body when the dispensing lid is secured to the body and a dispensing lid rotatably secured to the body for selectively opening and closing the access opening, wherein the dispensing cap comprises at least one of depleted uranium, tungsten, plastic impregnated with tungsten.

9. The elution tool according to claim 8, characterized in that the dispensing lid further comprises at least one magnetic coupler for releasably securing the dispensing lid to the body of the elution tool.

10. The elution tool according to claim 9, characterized in that the dispensing lid defines a receptacle for receiving the bottom of the body of the elution tool, wherein at least the magnetic coupler at least partially surrounds the receptacle.

11. The elution tool according to claim 10, characterized in that the body of the elution tool defines an annular coupler surface that is magnetically attracted to at least the magnetic coupler of the dispensing lid.

12. The elution tool according to claim 11, characterized in that the dispensing lid further comprises a locking bolt which can be received in a locking cavity defined in the annular coupler surface of the body of the elution tool to inhibit rotation of the Dispenser lid around the bottom of the body of the elution tool.

13. The elution tool according to claim 1, characterized in that it further comprises a storage cover that can be removably secured to the bottom of the body of the elution tool, wherein the storage cover comprises a body and a protection against the The body's radiation is secured, where the radiation protection is aligned with the access opening in the body of the elution tool when the storage cover is secured to the body of the elution tool, the radiation protection comprises at minus one of depleted uranium, tungsten, plastic impregnated with tungsten and lead.

14. The elution tool according to claim 1, characterized in that the elution body is sized and shaped to be held in a user's hand.

15. An elution tool for a radiopharmaceutical elution system, characterized in that it comprises: a body of the elution tool configured to be held in a user's hand, the body of the elution tool has an upper part, an opposing bottom, an opening in the upper part, a vial chamber extending from the opening in the upper part towards the bottom which is sized and shaped to receive an elution vial therein through the opening in the upper part and an access opening extending through the bottom to the vial chamber, the access opening is aligned with a septum of the elution vial when the elution vial is received in the vial, wherein the body of the elution tool and the dispensing cap comprise at least one of depleted uranium, tungsten, plastic impregnated with tungsten and lead; Y a dispensing lid that can be removably secured to the bottom of the body of the elution tool, the dispensing lid comprises a body of the dispensing lid having a dispensing access opening that is aligned with the access opening of the tool body of elution when the dispensing lid is secured to the body of the elution tool and a dispensing lid rotatably secured to the body of the dispensing lid to selectively occlude and expose the dispensing access opening.

16. The elution tool according to claim 15, characterized in that the dispensing lid further comprises at least one magnetic coupler for releasably securing the dispensing lid to the body of the elution tool.

17. The elution tool according to claim 16, characterized in that the dispensing lid defines a receptacle for receiving the bottom of the body of the elution tool, wherein at least the magnetic coupler at least partially surrounds the receptacle.

18. The elution tool according to claim 17, characterized in that the body of the elution tool defines an annular coupler surface that is magnetically attracted to at least the magnetic coupler of the dispensing lid.

19. The elution tool according to claim 18, characterized in that the dispensing lid further comprises a locking bolt which can be received in a locking cavity defined in the annular coupler surface of the body of the elution tool to prevent rotation of the Dispenser lid around the bottom of the body of the elution tool.

20. The elution tool according to claim 15, characterized in that the body of the dispensing lid has a density less than the density of the dispensing lid.

21. The elution tool according to claim 20, characterized in that the elution body is sized and shaped to be held in a user's hand.