Radiation-shielding assemblies and methods of using the same

ES 2 394 492 T3

DESCRIPTION

Radiation protection sets and procedures for their use

Field of the invention

The present invention relates generally to radiation shielding devices for radioactive materials and more particularly to radiation shielding assemblies that are used to confine radioactive materials used in the preparation and / or dispensing of radiopharmaceuticals.

Background

Nuclear medicine is a branch of medicine that uses radioactive materials (eg, radioisotopes) for various research, diagnostic, and therapeutic applications. Radiopharmacies produce different radiopharmaceuticals (ie, radioactive pharmaceuticals) by combining one or more radioactive materials with other materials to tailor the radioactive materials for use in a particular medical procedure.

For example, radioisotope generators can be used to obtain a solution comprising a radioisotope derived (eg technetium-99m) from a parent radioisotope (eg molybdenum-99) that produces the derived radioisotope by radioactive decay. A radioisotope generator can include a column containing the parent radioisotope adsorbed on a carrier medium. The carrier medium (eg, alumina) has a relatively higher affinity for the parent radioisotope than the derived radioisotope. As the parent radioisotope decays, a desired amount of the derived radioisotope is produced. To obtain the desired derived radioisotope, a suitable eluent (eg, sterile saline solution) can be passed through the column to elute the vehicle derived radioisotope. The resulting eluate contains the derived radioisotope (eg, in the form of a dissolved salt), which makes the eluate a useful material for the preparation of radiopharmaceuticals. For example, the eluate can be used as the source of a radioisotope in a solution suitable for intravenous administration to a patient for any of a variety of diagnostic and / or therapeutic procedures.

In a process for obtaining a quantity of the eluate from the generator, an evacuated container (eg, an elution vial) can be connected to the generator at an intake point. For example, a hollow needle in the generator can be used to pierce a septum of an evacuated container to establish fluid communication between the elution vial and the generator column. The partial vacuum of the container can draw the eluent from an eluent reservoir through the column and into the vial, thereby eluting the radioisotope derived from the column. The container may be contained in an elution shield, which is a radiation shielding device used to protect workers from radiation emitted by the eluate after it is received in the generator container.

After the elution is complete, the activity of the eluate can be calibrated by transferring the container to a calibration system. Calibration may involve removing the container from the shield assembly and placing it in the calibration system to measure the amount of radioactivity emitted by the eluate. A penetration test can be performed to confirm that the amount of the parent radioisotope in the eluate does not exceed acceptable tolerance levels. The penetration test may involve transferring the container to a thin shield cup (for example, a cup that effectively shields against radiation emitted by the daughter isotope, but not against the higher-energy radiation emitted by the parent isotope) and measuring the amount of radiation penetrating the shield cup.

After the calibration and penetration tests, the container can be transferred to a dispensing protector. Dispensing shields protect workers from radiation emitted by the eluate in the container since the eluate is transferred from the container to one or more different containers (eg, syringes) for later use in the radiopharmaceutical preparation process. Dispense protectors are generally lighter in weight and easier to handle than elution protectors for the dispensing process because each of the containers can be used to load multiple containers (for example, from time to time during the dispensing process). over the course of a day) and it is generally desirable to place the protected container upside down on a work surface (for example, the tabletop) during periods of inactivity between transferring the eluate into one container and the next. Prior art elution protectors are generally not conducive to use as dispensing protectors because, among other reasons, they can be unstable when inverted. For example, some elution shields have a heavy base that results in a relatively high center of gravity when the elution shield is inverted. Also, some elution protectors have top surfaces that are not adapted to rest on a flat work surface (eg, protruding top surfaces that would make the elution protector unstable if placed inverted on a flat surface). Radiopharmacies have addressed this problem by maintaining one supply of elution protectors and another supply of dispensing protectors. This solution requires a transfer of the container from an elution protector to an elution protector.

ES 2 394 492 T3 dispensing, which can undesirably expose a worker to radiation.

The same generator can be used to fill a number of containers before the radioisotopes are spent in the column. The volume of eluate required at any one time can vary depending on the number of prescriptions that need to be filled by the radiopharmacy and / or the remaining concentration of radioisotopes in the generator column. One way to vary the amount of eluate drawn from the column is to vary the volume of the evacuated vessels used to receive the eluate. For example, container volumes ranging from about 5 ml to about 30 ml are common and standard containers that have volumes of 5 ml, 10 ml, or 20 ml are currently used in industry. A container having a desired volume can be selected to facilitate the dispensing of a corresponding amount of eluate from the generator column.

Unfortunately, the use of multiple different sizes of containers is associated with significant disadvantages. For example, a radiopharmacy must either keep a supply of labels, rubber stoppers, metal flanged caps, spacers, and / or lead protectors in stock for each type of container it uses, or it must use protective devices that can be adapt for use with containers of various sizes. One solution that has been implemented is to keep a variety of different spacers on hand to take up additional space in radiation shielding devices when smaller containers are being used. Unfortunately, this increases complexity and increases the risk of confusion because spacers can get mixed up, get lost, broken, or used with the wrong container and are generally inconvenient to use. For example, some conventional spacers surround the walls of the containers in the guards, which is where the labels can be attached to the containers. Consequently, the spacers can damage the labels and / or adhesives used to fix the labels on the container thereby causing the spacers to stick to the walls of the container or otherwise damage the radiation protection device.

Therefore, there is a need for improved radiation shielding kits and procedures for handling containers containing one or more radioisotopes that facilitate safer, more convenient, and more reliable handling of radioactive materials produced for nuclear medicine.

US-A-4382512 describes a radiation shield comprising a container having a clear lid, a lid for containing a vial. The cap of the container can be inverted to engage and remove a stopper from the vial.

Other radiation shielding kits or constituents of such kits are described, for example, in US-A-4506155, JP07149361, WO00 / 62305, US-A-4084097 and US-A-539702.

Summary

One aspect of the present invention relates to a radiation shielding kit according to claim 1 that can be used to protect a radioactive material in an elution process and / or in a dispensing process. The assembly includes a body having a cavity and a cavity opening defined therein. The assembly also includes a cap adapted for releasable fixation (eg, by magnetism) to the body when the cap is in a first orientation relative to the body and for non-fixation connection to the body when the cap is in a second orientation relative to the body. body. Incidentally, a non-pinned connection or the like means that a first and second structures are interfaced but not pinned. An example of a connection without fixation would be the interface of a drink cup arranged on a cup holder.

The cap includes a radiation shielding material selected from lead, tungsten, and depleted uranium.

Another aspect of the invention relates to a method of using a radiation shielding assembly according to claim 5. In this method, a cover of the radiation shielding assembly is releasably attached to a body of the assembly to cover a opening in the body and limit the escape of radiation from the interior of the assembly. The cap is removed from the body and placed on a suitable support surface (eg, a work surface). The body is inverted and placed on top of the lid, so that the lid is in a different orientation relative to the body than it was when it was releasably attached to the body, thereby causing the lid and the body to be in contact. a connection without fixation. The body can be lifted from the lid to expose the opening.

The cap includes a radiation shielding material selected from lead, tungsten, and depleted uranium.

Also described is a radiation shielding kit that can be used to shield an eluate (eg, a solution that includes a radioisotope from a radioisotope generator). The assembly has a body that at least partially defines a cavity to receive the eluate. There is an opening through the body towards the

ES 2 394 492 T3 cavity at the end of the body. The body is designed / configured to limit the escape of radiation emitted by the radioisotope from the elution shield through the body. The assembly also has a base that can be releasably secured to the body at a second end thereof. The base has a side wall extension portion aligned with the circumferential side wall when the base is secured to the body. The base side wall extension portion has a relatively lighter weight construction compared to the circumferential side wall of the body. For example, the extension portion of the base side wall can be made of a material having a first weight density, and the circumferential side wall of the body can be made of another material having a second weight density greater than the first. weight density.

A method of manufacturing an elution shield for a radioisotope received from a radioisotope generator is also described. A body of the elution shield includes a radiation shielding material, and is formed to have a cavity for receiving the radioisotope therein. A base of the elution shield includes a material that would be substantially transparent to radiation emitted by the radioisotope. The base material is a relatively lighter weight material than the radiation shielding material of the body. The base is formed to connect the body and extend the overall length of the elution protector to a length greater than the length of the body.

Also described is a radiation shielding set for holding any one of a set of containers having different heights and which can be used to contain a radioactive substance. The assembly has a body that at least partially defines a cavity for receiving a container. The assembly can be constructed to limit the escape of radiation emitted into the cavity from the assembly. The cavity has opposite first and second ends. The assembly also has a spacer that may be disposed at least partially in the cavity (eg, at or near the end of the cavity). The spacer is selectively adjustable to change the amount of space between the spacer support surface and the first end of the cavity by translation of the support surface, such that the support surface places the containers in substantially the same location relative to the first end of the cavity.

Also described is a method of using a radiation shielding kit to handle containers that have so many different heights and that are used to contain a relative substance. A first container is located in a cavity defined in the radiation shielding assembly. A spacer is associated with the cavity and is used to position the first container at a predetermined location relative to one end of the cavity. The first container is subsequently removed from the cavity. The spacer is adjusted by moving the spacer along an axis of the cavity to change the amount of space between the spacer and the end of the cavity. A second container having a different height than the first container is placed in the cavity. Adjusting the spacer results in the second container being located in substantially the same predetermined location that the first container was relative to the end of the cavity.

A radiation shielding kit for a container containing a radioactive eluate is also described. The assembly has a body that at least partially defines a cavity for receiving the container. There is an opening through the body in the cavity. The opening is sized to allow the container to be placed in and removed from the cavity. The body of the assembly is constructed to limit the escape of radiation from the radioactive material through the body. The assembly also includes a locator in the cavity opposite the opening to at least help locate the container at a predetermined position in the cavity. The locator may be characterized as a guide that can be interfacially connected with one end of the container which is shaped such that, upon interfacial connection with the end of the container, the collar can at least generally be used to drive or direct the container into position. predetermined in the cavity. The locator can be from a wide range of materials. For example, the locator can include or be made entirely of a material that is substantially transparent to radiation.

A method of manufacturing a radiation shielding assembly for a container containing a radioactive eluate is also described. A body of the assembly includes shielding material capable of substantially limiting the passage of radiation through the material. The body is formed with a cavity to receive the radioactive eluate container. A locator is formed from a material that is substantially transparent to radiation, such that the locator can be received in the cavity and connected to the container when placed in the cavity to locate the container (e.g., to guide or direct the container towards) a predetermined position relative to the body in the cavity.

Also described is a radiation shielding assembly to contain any one of the set of containers having different heights that are used to contain a radioactive substance. The assembly has a body that at least partially defines a cavity for receiving a container. The assembly also has a spacer adapted to be received at least partially in the cavity. The spacer can be selectively placed in the cavity to occupy the space in the cavity to adapt the assembly for use with at least one of the smaller containers or removed from the cavity to adapt the assembly for use with at least one of the containers. bigger. The assembly may also have a base adapted for a releasable connection to the body. The base may have a defined storage receptacle inside that can receive

ES 2 394 492 T3 the spacer when the spacer is removed from the cavity.

Also described is a method of using a radiation shielding kit to contain containers having different heights that are used to hold a radioactive substance. A spacer is located in the cavity of the assembly to adapt the assembly for use with a first container. The first container may be substantially enclosed in the cavity. The first container is subsequently removed from the cavity. The spacer can also be removed from the cavity to adapt the assembly for use with a second container that is taller than the first container. When not in use, the separator can be stored in a storage receptacle formed in the assembly. The second container may be substantially enclosed in the cavity.

There are several improvements to the indicated characteristics with respect to the aspects mentioned above. Other features can be incorporated into the aspects mentioned above as well. These enhancements and additional features may exist individually or in any combination. For example, various features discussed below with respect to any of the embodiments illustrated in the present invention may be incorporated into any of the aspects of the present invention, alone or in any combination.

Brief description of the figures

Figure 1 is a perspective view of one embodiment of a radiation shielding assembly;

Figure 2 is an exploded view of the assembly of Figure 1;

Figure 3 is a vertical section thereof;

Figure 4 is an enlarged perspective view of a cover of the assembly resting on a supporting surface;

Figure 4A is a vertical section of the lid;

Figure 5 is a perspective view of the assembly on a supporting surface with the cover removed from and resting adjacent to a base of the assembly;

Figure 6 is a perspective view of the assembly on a support surface;

Figure 6A is a vertical section of the assembly on the support surface;

Figure 7 is a perspective view of a person lifting a body of the assembly out of the lid with one hand;

Figure 8 is a perspective view of the body;

Figure 9 is an enlarged fragmentary perspective view of a base and body as they are about to be connected to each other;

Figures 10A-10C are fragmentary body and base diagrams illustrating an exemplary connection sequence;

Figure 10D is a fragmentary diagram of a body and a base having a modified connection structure;

Figure 11 is a perspective view of part of an adjustable spacer system;

Figure 12 is an exploded perspective view of the base;

Figure 13 is a vertical section of the base of Figure 12;

Figures 14A-14C are elevations showing a sequence of indexed movement of a separator of the separator system through positions adapted for use with three progressively shorter containers;

Figures 15A-15C are vertical sections of the assembly showing a sequence similar to the sequence of Figures 14A-14C in which the assembly is adapted to hold three progressively shorter containers (shown in broken lines);

Figure 16 is a perspective view of another separator;

Figure 17A is a perspective view of a collar;

Figure 17B is a vertical section of the collar;

Figure 18A is a perspective view of another collar;

Figure 18B is a vertical section of the collar of Figure 18A;

Figure 19 is a vertical section of another radiation shielding assembly;

Figure 20 is a vertical section of a base of the radiation shielding assembly of Figure 19;

Figure 21 is a perspective view of yet another radiation shielding assembly;

Figure 22 is an exploded perspective view of the assembly of Figure 21;

Figures 23A-23C are vertical sections of the assembly of Figure 21 showing a sequence in which the assembly is adapted to contain three progressively taller containers (shown in dotted line);

Figure 24 is a perspective view of a base of the assembly of Figure 21 showing a storage compartment at the bottom of the base for storing a separator; Y

Figure 25 is another perspective view of the base similar to Figure 24 showing a spacer stored in the compartment in the base.

Corresponding reference characters indicate corresponding parts throughout the figures.

ES 2 394 492 T3

Detailed description of the illustrated embodiments

Referring now to the figures, first to Figures 1-3, in particular, one embodiment of a radiation shield assembly of the present invention is shown as a rear-loaded dual-purpose radioisotope elution and dispensing shield. , generally designated with the number 101. The assembly 101 may include a container (eg, eluate vial) containing a radioisotope (eg, technetium-99m) that emits radiation into a radiation-shielded cavity in the assembly, thereby limiting the escape of radiation emitted by the radioisotope of the set. Therefore, the kit can be used to limit radiation exposure for workers who handle one or more radioisotopes or other radioactive materials.

As shown in Figures 2 and 3, the illustrated assembly 101 generally has a body 103, a cap 105, a collar 107, and a base 109. The body 103 may include a circumferential side wall 115 that partially defines a cavity. 117 adapted to receive a container 119 (shown in broken lines). The cap 105 is removably attached to one end of the body 103 while the base 109 is removably attached to the other end of the body. Collar 107 may be received in cavity 117, if desired, to help guide container 119 to a desired position in body 103 as it is loaded into assembly 101. When assembled, as shown in Figures 1 and 3, the body 103, the lid 105, and the base 109 can be used to enclose the container 119 in the cavity 117 of the assembly 101 and form a shield unit that limits the escape of radiation into the cavity 117 from the assembly. 101.

The side wall 115 of the body 103 shown in the figures is substantially tubular, but the side wall can have other shapes (eg, polygonal) without departing from the scope of the invention. Side wall 115 can be adapted to limit the escape of radiation emitted in cavity 117 from assembly 101 through the side wall. For example, in one embodiment, side wall 115 includes radiation shielding material (eg, lead, tungsten, depleted uranium, or other dense material). The radiation shielding material can be in the form of one or more layers (not shown). Some or all of the radiation shielding materials may be in the form of a substrate impregnated with one or more radiation shielding materials (eg, a moldable tungsten-impregnated plastic). Those skilled in the art will know how to design body 103 to include a sufficient quantity of one or more radiation shielding materials selected in view of the amount and type of radiation expected to be emitted in the cavity and the applicable tolerance for exposure. radiation to limit the amount of radiation that escapes from assembly 101 through side wall 115 to a desired level.

One end of body 103 defines a first opening 121 in cavity 117 and a second end of body 103 can define a second opening 123 in cavity 117, as shown in Figure 3. The second opening 123 can be larger than the first opening 121. For example, the first opening 121 may be sized to prevent passage of the container 119 therethrough and yet allow at least one needle point (not shown) to pass through it (e.g. example, a needle in a pick-up point of a radioisotope generator). The body 103 shown in the figures includes, for example, an annular flange 127 extending radially inward from the side wall 115 near the top of the side wall. (As used herein, the terms upper and lower are used in reference to the orientation of the assembly 101 in Figure 3, but do not require any particular orientation of the position of the assembly or its component parts.) An inner edge 129 of flange 127 defines first opening 121, which may be a substantially circular opening. Flange 127 may have a chamfer 131 to facilitate orientation of the tip of a needle toward a pierceable septum (not shown) of container 119 received in the cavity. Flange 127 can be integrally formed with side wall 115 or manufactured separately and secured thereto. Flange 127 may include radiation shielding material, as described above, to limit radiation leakage from assembly 101. However, the flange 127 can be substantially transparent to radiation, without departing from the scope of the invention. Second opening 123 may be sized to allow passage of a container 119 therethrough for loading and unloading of containers to and from assembly 101.

The lid 105 can be removed from the assembly 101 as shown in Figure 5, so that the container 119 in the cavity 117 of the assembly can be fluidly interconnected with a radioisotope generator through the now exposed opening 121. Incidentally, fluidly interconnection or the like refers to a bonding of a first component to a second component, or to one or more components that can be connected to the second component, or to a bonding of the first component to a part of a system that includes the second component such that a substance (eg, an eluent and / or eluate) can be passed (eg, flowed) in at least one direction between the first and second components. The cap 105 of the embodiment shown in the figures is reversible. When the cap 105 is in a first orientation relative to the body 103 (shown in Figures 1 and 3), the cap can be removably attached to the body. When cap 105 is in a second orientation relative to body 103 (eg, inverted as shown in Figures 6 and 6A), cap 105 is adapted to engage without being attached to body 103. More specifically, Figures 6 and 6A show the cap in the same orientation as in Figures 1-3, while the body has been inverted relative to the cap and is placed upside down on the cap. The configuration of assembly 101 in Figure 3 may be considered by some to be convenient for transporting the radioactive eluate container 119 in cavity 117 from one location to another with

It is less concern of the cap 105 accidentally falling out of the body 103 and the need to expose people to radiation than if the cap 105 were simply set without being attached to the top of the assembly 101. The configuration of assembly 101 in Figures 6 and 6A may be found convenient to store radioactive eluate container 119 in an inverted position during the idle time between dispensing eluate from container 119 into the assembly within another container (e.g. example, a syringe) used downstream in the radiopharmaceutical preparation process. Additionally, some users may find that orientation convenient because it allows a person to access container 119 simply by lifting body 103 from lid 105 to expose first opening 121. For example, container 119 can be accessed by lifting body 103 with a single hand, as shown in Figure 7, leaving the other hand free to perform another action (for example, holding a syringe), in preparation for the dispensing process.

There are a number of ways to design a cap 105 that must be removably coupled to body 103 in the first orientation and adapted to engage without being attached to body 103 in the second orientation. The cap 105 shown in Figures 4 and 4A includes, for example, a magnetic portion 137 which attracts the body 103 when the cap is in the first orientation, thereby resisting movement of the cap 105 away from the body. In some embodiments, body 103 may be constructed of a material (eg, an alloy comprising one or more magnetic metals) that is attracted to magnetic portion 137 of cap 105. In other embodiments, the body 103 includes a material that has a relatively weak or no attraction to the magnetic portion 137 of the cap 105 and an attraction element (not shown) made of a material that has a relatively stronger attraction to the magnetic portion (eg, iron or the like) molded into or otherwise attached to the body to allow the magnetic portion of the cap to attract the body. However, when the cap 105 is in the second orientation, the attraction of the magnetic portion 137 of the cap to the body 103 is sufficiently attenuated (for example, by an increase in the distance between the body and the magnetic portion of the cap , Magnetic "shield", etc.), so that the weight of the cap is sufficient to freely separate the cap from the body when one of the body and cap is pushed away from the other. As shown in Figures 3 and 6A, for example, the cap 105 may be constructed so that the magnetic portion 137 thereof is positioned adjacent to (eg, in contact with) the body 103 when the cap is coupled to the body. in the first orientation (Figure 3) and separated from the body (eg, by a substantially non-magnetic material 139) when the cap engages the body in the second orientation (Figure 6A). The lid and / or body may be equipped with retainers, snaps and / or friction fit elements or other fasteners that are operable to fix so that the lid can be released to the base without the use of magnetism in the first orientation. and that they are substantially unusable for attaching the cap to the body in the second orientation, without departing from the scope of the invention.

Cap 105 is adapted to limit the escape of radiation emitted in cavity 117 from assembly 101 through first opening 121 when the cap is loosely attached to body 103 in the first orientation and when the cap is unattached. be attached to the body in the second orientation. Cap 105 includes one or more radiation shielding materials (not shown), as previously described. Those skilled in the art will be able to design cap 105 to include a sufficient amount of one or more radiation shielding materials to achieve the desired level of radiation shielding. In order to reduce costs, radiation shielding materials can be positioned in the center of the cap 105 (for example, coincident with the first opening 121 when the cap is positioned relative to the body, as shown in Figures 3 and 6), and the outer circumference of the cap can be made of lighter and / or cheaper materials without radiation protection, but this is not necessary to implement the invention.

Collar 107 (which, in some cases, may be referred to as a class locator container) may be positioned in cavity 117 to guide container 119 into a desired and / or predetermined position as it is loaded into the cavity. For example, the collar 107 can be coupled to the cavity 117 so that friction between the body 103 and the collar tends to hold the collar within the cavity. In other embodiments, collar 107 may be attached to body 103 by an adhesive or other suitable attachment method. In other embodiments, collar 107 may be an integral component of body 103. The collar 107 may be adapted to assist in the alignment of the top of a container 119 with the first opening 121 of the body 103 to facilitate piercing of the container septum with the tip of a needle into a radioisotope generator when the container is arranged in cavity 117 of body 103. In some embodiments, aligning the top (for example, the mouth) of the container 119 with the first opening 121 may require that the top of the container be centered in the cavity 117, but the predetermined position in which the container is constructed collar to guide the container may vary depending on the particular configuration of the assembly.

In the embodiment shown in Figure 3, the collar 107 can be positioned in the cavity 117 adjacent to the first opening 121 and opposite the second opening 123. Referring to Figure 3, in conjunction with Figures 17A-B, the collar 107 has an opening 145 extending between the first and second sides of the collar. A first opening is defined on the side of the collar 107 facing the second opening 123 of the body 103, and a second opening of the collar is defined on the side of the collar facing the first opening 121 of the body. Opening 145 can receive at least a portion of a container 119 that is loaded into the cavity through second opening 123 in body 103. Aperture 145 is configured so that collar 107 guides or directs container 119 toward the predetermined position upon engagement of the interior portion of collar 147 with the forward end of the container as it is loaded into cavity 117. For example, the first opening of the

ES 2 394 492 T3 aperture 145 may be larger in size than the second aperture of the aperture. The opening 145 of the collar 107 shown in Figures 17A and 17B is somewhat analogous to a funnel in that it is tapered. Collar 107 may have a different shape (eg, shaped to define a stepped or tiered opening 145 'like collar 107' shown in Figures 18A and 18B), without departing from the scope of the invention. The top of opening 145 that is defined in collar 107 may be configured to engage or at least generally interface with approximately the upper third portion of a lid 119a of container 119 held in cavity 117, as shown in FIG. Figure 3. It should be noted that other embodiments of the top of the opening 145 may be configured to engage or at least generally interface with more or less than about the top third of the lid 119a on the container 119. As illustrated, the collar 107 can be operated to align (eg, in the center) a container partition 119 with the first opening 121. The portion of the container 119 that engages the collar can vary in size and / or location, without departing from the scope of the invention.

The collar 107 can be constructed of any suitable material, such as a relatively inexpensive, lightweight, durable low friction material (eg, polycarbonate). Furthermore, the material can be substantially transparent to radiation. In fact, since the body 103 of the assembly 101 generally includes the radiation shielding material, it may be desirable to also include radiation shielding material in the collar 107. In other words, the collar 107 of some embodiments may include radiation shielding material only to the extent that such radiation shielding material is needed to achieve a desired and / or required level of radiation shielding for a specific application. The use of a material that is transparent to radiation for the shaping of the collar 107 can beneficially allow the weight and / or cost of the assembly to be reduced. Those skilled in the art will appreciate that the cost of machining a cylindrical cavity 117 in the body 103 may tend to be less than the cost of machining a cavity in the molded body to form one or more positioning structures (eg, protrusions). on the body that have to be used to guide the containers in the same way as the collar 107. Radiation shielding materials can be difficult to machine and may tend to be more expensive than other materials that can be used in the collar 107. Also, the overall weight of the assembly can be reduced by making the collar 107 of a relatively lightweight material rather than make it of relatively heavy materials that can be used to make the body 103. It is understood, however, that the body 103 can be manufactured by any method (eg, molding) without departing from the scope of the invention. Furthermore, the use of other types of locators in place of a collar is considered to be within the scope of the invention. Furthermore, some embodiments of the invention have collars that include radiation shielding materials.

Base 109 can be releasably secured to body 103. As best seen in Figures 12 and 13, base 109 shown in the figures includes an extension member 161, a base guard member 163, and a system of spacers 165. Extension member 161 may have a generally tubular structure with an open upper end 171 adapted to make a releasable connection to body 103 (eg, adjacent second opening 123) and a closed lower end 173. Extension member 161 may be constructed of one or more relatively inexpensive, lightweight, and durable materials, such as high-impact polycarbonate materials (eg, Lexan®), nylon, and the like. The lower end 173 of the extension member 161 can be flared outward to provide a wider footprint for added stability when the assembly 101 is placed bottom-down on a work surface (as shown in Figure 1). Extension member 161 can be used to lengthen assembly 101, including the combined length of body 103 and base 109. For example, extension member 161 may include a circumferential side wall 181 that corresponds generally to the circumferential side wall 115 of body 103 as shown in Figure 1. As is known to those skilled in the art, some radioisotope generators They are designed to work with a guard assembly that has a minimum particular length (for example, six inches). Extension element 161 can be used in combination with a body 103 that would otherwise be too short for a particular radioisotope generator to meet the minimum length requirement of such a generator. The base extension member 161 can be transparent to radiation because other parts of the assembly 101 can be designed to achieve the desired level of radiation protection. The use of a relatively lightweight extension element 161 (for example, no radiation shielding) to provide the required length allows the assembly 101 to be lighter and / or less expensive compared to a similar assembly that is constructed with a relatively heavy weight. larger and / or more expensive materials (eg radiation shielding materials) over the entire minimum length required by a particular radioisotope generator. There may be a vacuum (illustrated here as a receptacle 203) in the base for additional weight reduction. For example, in one embodiment of the invention, the total weight is no more than about 1.81 kg (4 pounds) (1 pound = 0.45 kg). In another embodiment, the weight is no more than about 1.36 kg (3 pounds). The use of the relatively lightweight extension element 161 can also shift the center of gravity of the assembly 101 toward the end of the body 103 defining the first opening 121, making the assembly more stable when inverted for use as a dispensing shield. (See, Figure 6).

The base 109 can be adapted to be releasably attached to the body 103 by a quick turn connection 191 (for example, a connection in which the base can be attached to and / or released from the body by rotating the base relative to the body in no way). more than approximately 180 degrees) as shown in Figure 9. When the base 109 is rotated to release it from the body 103, the quick-turn connection 191 can be adapted to provide a

ES 2 394 492 T3 positive indication that the base has been rotated sufficiently relative to the body to allow the assembly 101 to open. Allow separation of the base 109 from the body 103 by rotating the base through a relatively small angle relative to the body (e.g., approximately 45 degrees in the illustrated embodiment) and / or provide a positive indication that the assembly 101 can be opened by pulling the base away from the body, can help reduce the risk of accidentally dropping the base (and perhaps allowing a container filled and / or contaminated with radioactive materials to fall out of the body) in the course of opening the assembly, as might occur with a protective kit Conventional, if a worker adjusts his grip on the assembly to rotate the base a little more when, behind the workers' backs, the base has already been rotated enough to free the base from the body.

Referring to the deployments shown in Figure 9, for example, the quick-turn connection 191 that secures the base extension member 161 and the body 103 can be a bayonet-type connection. Base extension member 161 may include a plurality of connection members 193 (eg, claws, threads, or the like) adapted to establish connection with a corresponding plurality of connection members 195 at the lower end of body 103. The contact angle α (Figure 10c) between the corresponding connection elements 193, 195 can be selected to provide a secure connection that makes the assembly 101 unlikely to open unintentionally as it is pushed during handling and / or does little. quick-turn connection 191 is likely to get stuck when someone tries to open the assembly.

Referring to Figures 10A-10C, for example, the contact angle α between the claws 193 on the base extension member 161 and the engagement claws 195 on the body 103 can vary from a relatively less steep angle than empirically demonstrated to allow separation of the base 109 from the body, no jamming up to a relatively steeper angle that is approximately equal to the arctangent of the friction coefficient between the coupling connecting elements, both of which can vary depending on the materials used to form the connecting elements. As the coefficient of friction decreases, the contact angle α may be less pronounced. The coefficient of friction can be between about 0.1 to about 0.2. In other deployments, the coefficient of friction is between about 0.12 and about 0.15. In still other deployments, the coefficient of friction is approximately 0.12. The contact angle α can vary from about 2 degrees to about 10 degrees. In other deployments, the contact angle α can vary from about 5 degrees to about 10 degrees. It is understood that a quick turn threaded connection (eg, a multi-start threaded connection) between the body 103 and the base 109 can be provided with substantially the same contact angles described with reference to the bayonet type connection 191 to reduce the risk of inadvertent opening of the assembly and to reduce the likelihood of jamming when someone tries to open the assembly 101. Incidentally, some deployments may exhibit contact angles and / or coefficients of friction that are outside the ranges described above.

Quick turn connection 191 shown in Figures 9-10C can provide a positive indication when base 109 has been rotated sufficiently relative to body 103 to allow opening of assembly 101 limiting further rotation of the base when base is able to separate from the body. For example, claws 193, 195 can be adapted to function as shutters when base 109 has been rotated enough to open assembly 101. With reference to Figures 10A-10C, for example, the generally trapezoidal claws 193, 195 on the base 109 and the body 103 can be sized and spaced so that the claws on the base can pass between the claws on the body (Figures 10A and 10B). Quick turn connection 191 can be established by rotating base 109 relative to body 103 to cause claws 193, 195 to engage each other as shown in Figure 10C. As the base 109 is rotated in the opposite direction to open the assembly 101, the claws 193, 195 reach a point where the claws on the base can pass between the claws on the body. At that point (Figure 10B), the claws 193 on the base 109 abut against the claws 195 on the body 103, thereby limiting the amount of rotation of the base that is possible. When a person opening assembly 101 feels claws 193, 195 contact (for example collide), he or she knows that base 109 can be detached from body 103 without further rotating the base relative to the body. . Figure 10D shows another embodiment of a quick turn connection 191 'in which the claws 193' on the base 109 'include ribs 193a' extending on their upper side. There may be clearance between claws 193 ', 195' (except for ribs 193a '), but claws 195' collide with ribs 193a 'to provide a positive indication that assembly 101 can be opened.

The base guard element 163 can be connected (either directly or indirectly as shown in Figure 3) to the base extension element 161 so that the connection of the base extension element to the body 103 interconnects the protection element of the base with the body. The base shield element 163 can be operated to limit the escape of radiation emitted in the cavity 117 from the assembly 101 through the second opening 123 when the base extension element 161 is connected to the body 103. As shown in Figure 3, for example, the base guard 163 may include a connector adapted to slideably be received by the second opening 123 of the body 103 in the cavity 117. The base shield element 163 can be adapted to absorb and / or reflect radiation over an area that is substantially coextensive with the second opening 123, for example, by being configured as a plate that is substantially the same shape and size as the opening. . The base protection element can be adapted

ES 2 394 492 T3 to substantially cover the second opening 123 without being received therein. The base protection element

163 it may include one or more radiation shielding materials (not shown), as described above. Those skilled in the art will know how to design a base shield 163 to include a sufficient quantity of one or more radiation shielding materials to limit the escape of radiation from the assembly 101 through the second opening 123 in a desired level.

Divider system 165 may include an adjustable spacer 201, which can be at least partially received, in cavity 117 to selectively configure assembly 101 to hold a container selected from a set of containers that include containers that have different heights (e.g., different volumes). Referring to the figures, for example, the spacer 201 can be slidably mounted in the receptacle 203 at the base 109 (eg, a substantially cylindrical receptacle on the base extension member 161). The receptacle 203 in the base 109 may be adjacent to the second opening 123 in the cavity 117 of the body 103 when the base is attached to the body, thereby positioning the spacer 201 for extension into and slidable retraction out of the cavity 117 . The base guard 163, which may define a supporting surface for the container 119 when received in the cavity 117, can be secured (for example, by a threaded connection or other attachment method) or be integral with the separator 201. By selectively positioning the spacer 201 with respect to the first opening 121, the position of the base guard 163 relative to the first opening 121 of the body 103 can be changed to position the top of each of the containers 119 in substantially the same location in relation to the first opening, despite their different heights.

Separator 201 can be mounted to assembly 101 in a variety of different ways. For example, the spacer 201 shown in the figures has a substantially cylindrical surface (eg, outer surface) having a helical channel 205 defined therein. A detent 209 received in channel 205 may be another component of spacer system 165. In some deployments, such as that shown in the figures, for example, the retainer 209 is associated with (eg, mounted to) the base extension member 161, but in other embodiments the retainer may be associated with other elements of the assembly. 101. The retainer 209 may be substantially fixed relative to the body 103 (eg, when mounted on the base 109 while attached to the body). The detent 209 of the displays shown in the figures is a ball check plunger. The ball check plunger may be a threaded member 211 having a loosely captured ball 213 therein. A spring (not shown) can be positioned on threaded member 211 to bias balloon 213 to a position where a portion of the ball projects outwardly from one end of the threaded member. The threaded member 211 can be screwed into the base extension member 161 so that the end of the threaded member to which the ball 213 deflects is received in the channel 205. However, other retainers could be used in its place. The retainer 209 could be a cam, and the spacer 201 as a cylindrical cam follower. The retainer 209 engages one side of the helical channel 205 upon rotation of the spacer 201, causing movement (for example, along an axis 197 of the cavity 117) of the spacer relative to the socket 203 in the extension member of the base 161. Depending on the direction of rotation, spacer 201 can be moved out of or into receptacle 203, corresponding to the furthest translation in cavity 117 and out of cavity in assembly 101, respectively.

Furthermore, as shown in Figures 11 and 12, a plurality of recesses 217 adapted to engage the end of the ball check plunger 209 may be formed at the bottom of the helical channel 205. Only some of these recesses 217 are shown in the figures. Each of the recesses 217 may be aligned with the ball 213 of the ball check plunger 200 when the spacer 201 is in one of the positions where the spacer is adjusted for use with a particular of the containers in the assembly. Therefore, when the spacer 201 is moved into that position, the tip 213 of the ball check plunger 209 can engage the respective recess 217 producing an audible click and / or tactile feedback to indicate that the spacer is in position. The recesses 217 can help maintain the spacer 201 in the selected position. In addition, the spacer 201 may include markings 221 that indicate the different heights of the containers located in the spacer relative to the helical channel 205 so that when the spacer is positioned for use with one of the containers, the corresponding mark is on a predetermined position where it is visible while the other marks are hidden from view. As shown in the figures, for example, a window 223 is formed in the base 109 below the ball check plunger 209. The markings 221 are located on the outer surface of the spacer 201 at positions that are out of phase from (for example , below) the respective recess 217 by an amount corresponding to the amount of displacement between the retainer 209 and the window 223. When the ball 213 of the ball check plunger 209 engages one of the recesses 217, the corresponding mark 221 is visible in the window 223. The remaining markings 221 are covered by the base extension element 161 so that workers can observe what type of container is held in the assembly 161 by looking through the window 223 to see the corresponding marking 221, thereby eliminating the need to open the assembly 101 to determine or confirm what type of container is in the assembly.

Figures 14A-14C and 15A 15C show, for example, an adjustment sequence of the spacer system 165 for three containers 119 ', 119, 119' having three different heights. Figure 14A shows the separator 201 positioned for use with a 20 ml container 119 '(Figure 15A), as indicated by the lowered position of the separator and the 221 mark of 20 on the separator that is visible in window 223 a through extension element

ES 2 394 492 T3 of the base 161. By rotating the spacer 201 with respect to the base extension member 161 generally about a central longitudinal axis of the base extension member, the spacer can be raised to suit the assembly to which it supports a small 10 ml container 119 (Figure 15B). The spacer 201 is shown in this position in Figure 14B, in which the mark 221 of 10 is visible in the window 223 and the spacer has been raised above its position in Figure 14A. As the separator 201 is rotated further, the separator runs further up the ball check plunger 209 and is clamped, to adapt the assembly 101 for use with an even shorter 5 ml container 119 '(Figure 15C). The spacer 201 is shown in this position in Figure 14C, in which the mark 221 of 5 is visible in the window 223 and the spacer has been raised above its position in Figure 14B.

When the separator 201 is adjusted to the desired position, the base 109 can be connected to the body 103 to confine a container 119 in the assembly 101. Figures 15A-15C show 20 ml, 10 ml, and 5 ml containers 119 ', 119 , 119 'confined in array 101, respectively, with spacer 201 adjusted accordingly. As shown in Figures 15A-15C, the ball check plunger 209 engages one of the recesses 217 in the helical channel 205 in each of three positions corresponding to one of the container heights 119 ', 119, 119 ', providing an indexed movement of the separator 201 from a position suitable for use with one of the containers to a position suitable for use with a different one of the containers. It is understood that other constructions to adapt the assembly to work with containers having different heights can be used within the scope of the present invention.

Referring to Figure 16, a second spacer 201 'suitable for use with assembly 101 shown in Figures 1-3, may include a first helical channel 205a' and a second helical channel 205b '. The first channel 205a 'can be calibrated for use with a first set of vessels (for example, American standard vessels) and the second channel 205b' can be calibrated for use with a second set of vessels (for example, European standard vessels ). Recesses 217 and markings 221 'may be provided for each of channels 205a', 205b 'in the same manner as described for separator 201 described above. This allows the same set 101 to be used for indexed movement of the spacer 201 'for several different sets of containers. In order to change from one set of containers to another, the ball check plunger 209 is removed from one of the helical channels 205a ', 205b' (for example, partially unscrewing the threaded member 211 removing the retainer out of the channel) , the spacer 201 is repositioned to align the other helical channel with the retainer, and the ball detent plunger is replaced by what is received in the other helical channel.

The base 109 of the assembly 101 shown in Figures 1-3 can be disconnected from the body 103 to load a container 119 (eg, an evacuated elution vial) into the well. A worker can adjust the position of the separator 201 in preparing the assembly 101 for use with a particular container selected from a set of containers that includes containers having different heights. As the spacer 201 moves into position (for example, grasping and rotating an exposed portion of the spacer and / or base guard 163), the ball detent plunger 209 can engage the corresponding recess 217, producing an audible click and / or tactile sensation indicating to the worker that the spreader is in position. The position of the spacer 201 can be confirmed by looking through the window 223 in the base extension member 161 to see which of the markings 221 is visible thereon.

Container 119 can be loaded into cavity 117 through second opening 123 in body 103. Collar 107 engages the top of container 119 and guides it to the predetermined position in cavity 117 (for example, in a that the septum at the top of the container is centered under the first opening 121). The base 109 can then be connected to the body 103 to enclose the container 119 in the cavity 117. The spacer 201, after being adapted to the height of the container C, supports the container so that its top is adjacent to the first opening 121. Those skilled in the art will recognize that it is possible to adjust the position of the spacer 201 in the cavity 117 after base 109 is connected to assembly 101, without departing from the scope of the invention.

The cap 105 can be removed for an elution process. For example, after cap 205 is removed (Figure 5), container 119 can be connected to a radioisotope generator by piercing the septum of container 119 with a needle in fluid communication with generator 121 through the first container access opening. The eluate can then flow into container 119 through the needle (eg, using a vacuum pressure in the container to draw the eluate from the generator). The needle can be removed from the container when the container 119 has received a desired volume of eluate. Cap 105 can be releasably attached to body 103 to limit the escape of radiation emitted by the eluate from assembly 101 through first opening 121. Because the cap 105 is held in the body 103 (eg, by the magnetic attraction between the cap and body) the cap is less likely to accidentally fall out of the body. The container 119 can be moved to another location, such as a docking station, while the assembly with the lid removably attached to the body 103 is in the first orientation.

When the eluate is ready to be dispensed into other containers (for example, syringes or other types of containers used for post-processing of the eluate), the cap 105 can be removed from the body 103 and fitted open.

ES 2 394 492 T3 down at the bottom on a work surface. The body 103 and base 109 of assembly 101 can then be reversed and placed in cover 105 as shown in Figure 6, for example. Cap 105 engages body 103 and limits the escape of radiation emitted by the eluate. When a worker is willing to transfer some of the effluent from the reservoir 119 in the assembly to a different container, he or she can simply lift the body 103 and base 109 out of the lid 105 to access the container through the first opening. 121. For example, the body 103 and the base 109 can be lifted from the lid 105 with one hand (as shown in Figure 7) and held by hand while the eluate is transferred to the other container (for example, by perforation septum of container 119 with the tip of a needle attached to a syringe and draw the eluate into the syringe). After a desired amount of eluate material has been removed from container 119 in assembly 101, body 103 and base 109 can be replaced in cap 105 until more eluate needs to be removed from the container.

When the container 119 is emptied or when the eluate in the container is no longer needed, the base 109 can be rotated relative to the body 103 to open the assembly 101. A worker can manually rotate the base 109 relative to the body 103 . Due to the quick-turn connection 191, the worker is able to release the base 109 from the body 103, rotating the base by no more than approximately 180 degrees, which can be done without requiring the worker to release their grip on the body or base. to rotate the base even more. Base 109 can be released from body 103 by rotating the base by no more than about 90 degrees. In other deployments, the base can be released from the body by rotating the base by no more than approximately 45 degrees. Furthermore, when the base 109 has been rotated a sufficient amount to release the base from the body 103, the worker receives a positive indication (e.g., a tactile sensation such as an inability to rotate the base further) that no rotation is required. additional base to separate the base from the body. This alerts the worker to the need to maintain a firm grip on the base 109 and the body 103, thereby reducing the risk that the base will accidentally separate from the body and possibly allow the container 119 to fall out of the assembly 101. .

When the base 109 is separated from the body 103, the container 119 can be removed from the cavity 117. Then another evacuated container 119 can be selected and the process repeated. If the new container has a different height than the old container, the spacer 201 can be adjusted accordingly.

Figures 19 and 20 illustrate another embodiment of a radiation shielding assembly, generally designated 501, of the present invention. Except as noted, the illustrated assembly 501 is constructed and functions the same as the assembly 101 described above. Both assemblies 501, 101 include the same body 103, the cover 105, the base guard 163, and the spacer system 165. Base 509 of set 501 is similar in overall form and function to base 109 described above. One difference is that the base 509 comprises a radiation shielding element 521 and an unshielded element 523. Shield element 521 can be constructed of a relatively dense radiation shielding material (for example, a moldable tungsten-impregnated plastic material), while unshielded element 523 can be constructed of one or more relatively inexpensive, lightweight, and lightweight materials. durable, such as high impact polycarbonate materials (eg, Lexan®), nylon, and the like. The unprotected element 523 may surround at least a part of the protection element 521.

For example, shield element 521 shown in the figures has a generally tubular portion 529. A moldable plastic material can be molded over shield element 521 to form the bare element. An end 531 of guard member 521 may extend from the bare member and adapt to releasably secure base 509 to body 103 in substantially the same manner as base 109 of assembly 101 described above. As shown in Figures 19 and 20, the tubular portion 529 of the shield element may transition from a relatively thicker portion 535 at the end that is closest to the body 103 when the base is attached to the body at a relatively thick portion. thinner 537 at the opposite end. In addition, the bare element 523 may extend further from the body 103 than the shield element 521 when the base 509 is attached to the body. Consequently, the radiation shielding provided by base 509 can be concentrated on the portion of the base that is adjacent to the radioactive material in container C. In addition, the center of gravity of assembly 501 shifts towards the end of the assembly opposite the base (compared to where it would be if the entire base were made of radiation shielding material), thus increasing the stability of the assembly when it is placed on a supporting surface (eg, in a manner analogous to the way that the assembly 101 described above is oriented in Figures 6 and 6A).

The bare element 523 may have an internal surface that defines a plurality of inwardly extending ridges 525. Shield member 521 may have an outer surface defining a plurality of outwardly extending ridges 527 such that inwardly extending ridges 525 of the unshielded member engage grooves 547 defined by extending ridges. outwardly and the outwardly extending ridges 527 engage the grooves 545 defined by the inwardly extending ridges. The unprotected element can be fixed to the protection element by engaging the grooves and flanges. One of the advantages of forming the bare element 523 in an overmolding process is that the ribs 525 extending into it can be formed in situ at

ES 2 394 492 T3 in relation to the grooves defined by the outwardly extending ridges of the shield element. It is understood that the base 509 shown in Figures 19 and 20 can be used with radiation shielding assemblies having other configurations than those shown herein, without departing from the scope of the present invention.

Other deployments are depicted in Figures 21-23C such as a dual-purpose front-loading radiation shield assembly, generally designated 301, that is suitable for use as an elution and / or dispensing shield. As best seen in Figure 22, the assembly includes a cap 305, a body 303 that at least partially defines a cavity 317, a spacer 365, and a base 309. Assembly 301 is generally similar in construction and operation to assembly 101 described above.

Body 303 can be a two-part body that includes a main body 311 and a cover 313. Main body 311 may be a generally tubular structure having an open upper end 333 defining an opening 323 (Figure 22) sized to allow a container 119 to pass through to load and unload containers to and from cavity 317. and a closed lower end 363 adapted to limit the escape of radiation emitted in cavity 317 from assembly 301 through the lower part of body 303. The cover 313 is adapted to be received in the opening 323 of the main body 311. In addition, the cover 313 defines an opening 321 which may be similar to the first opening 121 of the assembly 101 described above. Cap 305 may be similar in construction and operation to cap 105 of assembly 101 discussed above.

The spacer 365 shown in Figures 22-23C may be a cylindrical sleeve having a perpendicular cross support 367 that spans the internal diameter of the spacer. Spacer 368 may be located as shown at 21A for use with a relatively shorter container 119 '' '. To adapt assembly 301 for use with a taller container 119 '', spacer 365 can be inverted as shown in Figure 23B. To adapt assembly 301 for use with an even taller container 119 ', spacer 365 can be removed from the cavity.

The lower portion of the main body 311 may be adapted for connection (eg, a threaded connection) to the base 309. The base of the display shown in the figures may be of similar construction to the lightweight base extension element described above. . The separator system 165 described above is not used in this deployment and the base guard 163 can be omitted because it would be redundant with the closed lower end 363 of the main body 311. The base 309 defines a storage receptacle 385 sized and shaped to store separator 365 when not in cavity 317. Base 309 and / or spacer 365 may be adapted to releasably secure the spacer within storage receptacle 385 to prevent the spacer from slipping out of the storage receptacle. For example, base 309 may include stops 367 (Figures 23A, 23C, and 24) adapted to engage recesses 389 in the spacer to establish a snap connection between spacer 365 and base 309. However, other fasteners could be used. .

The use of assembly 301 is generally similar to the use of assembly 101 described above. One difference in use is the manner in which containers 119 are loaded into and out of cavity 317. Assembly 301 can be used for elution and dispensing just like assembly 101 previously described. The spacer 365 can be adjusted for a particular container selected from a set of containers 119 ', 119 ", 119"' having different heights. When the separator 365 is not in use (for example, when the tallest container 119 'of the assembly is held in the cavity 317) the separator can be stored in a storage receptacle 385 at the bottom of the base 309, as shown in Figures 23C and 25. For example, the storage receptacle 385 can be sized and shaped to allow the spacer 365 to be inserted into the storage receptacle such that the spacer is in close fitting relationship with the sides of the receptacle. By inserting spacer 365 into receptacle 385, the user can engage a snap fit (as shown in the Figures), a friction fit, or other suitable means of securing the spacer in the receptacle. The user can secure the spacer 365 in the receptacle 385 after it is already in the receptacle (eg, using a separate fastener, for example).

Those skilled in the art will recognize that the radiation shielding assemblies 101, 501 described above can be modified in many ways without departing from the scope of the invention. For example, the cap may be a releasable, non-reversible cap attached to the body by a bayonet connection, a threaded connection, a snap-in connection, or other suitable releasable fastening system without departing from the scope of the invention. The collar can be omitted if desired. The set can be modified to fit virtually any style of container. Also, the set can be modified for use with other styles of radioisotope generators. A set can be used for elution only or for dispensing only without departing from the scope of the invention.

In view of the foregoing, it will be seen that the various objects of the invention are achieved and other advantageous results are achieved.

ES 2 394 492 T3

When introducing the elements of the present invention or illustrated embodiments thereof, the articles a, an, the, and said / said are intended to mean that there is one or more of the elements. The expressions comprising, including, and having and variations of these terms are intended to be inclusive and mean that there may be items in addition to the items in the list. In addition, the use of upper and lower 5 and variations of these terms is for convenience, but does not require any particular orientation of the components.

Since various changes could be made to the above assemblies and procedures without departing from the scope of the invention, it is intended that all matter contained in the foregoing description and shown in the accompanying figures 10 be construed as illustrative and not in a limiting sense. .