Patent Description:
This invention relates to hazardous materials, for example radiopharmaceuticals. In particular this invention relates to a compression member for a pig for storing, transporting and dispensing of liquid and capsules formulations of biohazardous products and substances in liquid and solid form, for example radiopharmaceuticals.

The transportation of biohazardous materials and substances, for example radioactive materials or biological substances such as pathogens, presents a potentially dangerous situation and must be subject to strict controls.

For example, radioactive pharmaceutical products, commonly known as "radiopharmaceuticals," are prepared for patient injection, ingestion or other forms of administration in specially equipped and controlled facilities. Radiopharmaceuticals are well known for use as markers in nuclear medicine diagnostic procedures, and to treat certain diseases.

Unless properly shielded, such products become a radiation hazard for individuals handling the product. For example, radioiodine pills or capsules that can be used for treating certain pathologies such as thyroid diseases or in conjunction with a diagnostic procedure to diagnose certain types of illnesses, are stored before use in a container typically made of plastic, for example a polyethylene pill bottle. In the case of a liquid radiopharmaceutical the container is typically a glass vial. Neither of these containers have any radioactivity-shielding properties. Therefore the storage, transportation and dispensing of radiopharmaceuticals is carefully controlled by rules designed to regulate the handling of such materials in a manner that reduces the radiation hazard.

Each metered (for example assayed or calibrated) dose of the radiopharmaceutical product, for example in the case of a treatment for thyroid issues a radioiodine pill, or in the case of isotopes used in Nuclear Medicine (SPECT) and positron emission tomography (PET) diagnostic procedures a liquid, is placed by the manufacturer into the container to be shipped to a qualified facility for administration to a particular patient or patient category. At the radiopharmacy stock vials of different radiopharmaceuticals are dispensed as unit doses. This represents the first opportunity for hazardous exposure to the radioactive contents, and accordingly is effected at the manufacturer in a shielded booth or other enclosure, or under other radioactivity-shielded conditions.

The container containing the radiopharmaceutical must then be shipped to the destination hospital or clinic for administration to the patient. To effect this safely, the container is dropped into a radioactivity-shielding container commonly known as a "pig" for interim storage and delivery to the destination.

A conventional pig comprises a two-part vessel which is either formed from a radioactivity-shielding material, for example lead or tungsten, or has an exterior shell encasing a radiopharmaceutical container compartment that is lined with a radioactivity-shielding material such as lead or tungsten. A non-limiting example is described and illustrated in <CIT>.

When the pig is assembled, the radiopharmaceutical container compartment is sealed in order to contain the radiation and thus minimize human exposure to the radioactive contents of the radiopharmaceutical compartment. The compartment is sized to accommodate the radiopharmaceutical product, in the ingestible radioiodine example a pill or dissolving capsule, or in the case of a liquid of radiopharmaceutical a vial, syringe, ampule or other glass container. In each case the radiopharmaceutical compartment would be dimensioned accordingly.

Once the radiopharmaceutical container has been placed into the radiopharmaceutical compartment and the pig assembled, the pig is ready to be shipped to the patient's location. Because this part of the delivery process occurs entirely within the confines of the manufacturing plant, which is specifically designed and staffed so as to meet all regulatory guidelines and procedures, there is less chance of human exposure to the radioactive radiopharmaceutical product up to the point that the pill, capsule, vial, syringe or the like is sealed in the radiopharmaceutical container compartment of the pig. As is well known, the pig is designed to provide optimal shielding so as to reduce exposure during shipping. The transportation phase is a second opportunity for exposure to the radioactive contents of the radiopharmaceutical container, posing an occupational exposure opportunity for the driver/courier.

At the destination staff trained in handling radioactive substances, for example a nuclear medicine technologist or technician, opens the pig and then removes the closure from the radiopharmaceutical container to vent the container bottle. This is the third opportunity for exposure to the radioactive contents of the radiopharmaceutical container, in the presence of hospital or clinic staff. The technologist must transfer the radiopharmaceutical to a Dose Calibrator to assay (measure) the activity of the radiopharmaceutical, which must be within <NUM>% of prescribed activity. After recording the assay, the technologist must retrieve container containing the radiopharmaceutical and return the radiopharmaceutical container to the pig's radiopharmaceutical container compartment, which is the third opportunity for exposure to radioactivity. The technologist then applies the lid to the pig for delivery to the patient.

The pig is opened in the patient's presence in order to gain access to the radiopharmaceutical container and remove the container closure for administration of the radiopharmaceutical product to the patient, providing a fourth opportunity for exposure to the radioactive contents of the radiopharmaceutical container. In this step exposure of radioactivity to the ambient environment is unavoidable in order to access the radiopharmaceutical product for administration to the patient, so great care must be taken to handle the unshielded radiopharmaceutical product using proper safety equipment and procedures.

However, the assaying process, and the venting of the container in the case of certain volatile radioactive substances which produce radioactive iodine vapours such as <NUM> Hocline capsules, can present unnecessary points of risk of exposure to the technologist and other staff. Although the types of destination facilities to which these products are shipped are equipped to properly handle radiopharmaceutical products and the staff at such facilities are well trained in safety policies and procedures, this step in particular can increase the risk of human exposure to the radioactive contents of the radiopharmaceutical product.

There is accordingly a need for a radiopharmaceutical pig that reduces opportunities for human exposure to the contents of the container when the pig reaches a hospital or clinic setting and the product in the container is exposed to the ambient environment. Such a pig is disclosed in <CIT>.

While the inventions disclosed in the above-noted application to Kamen are useful, improvements are desirable. For example, improvements to the compression member to be disposed intermediate at least a container closure and the pig are desirable.

<CIT> relates to a locking cover, made of a molded plastic material, for a vessel having a neck, intended for locking a plug in the neck of the vessel, including a wire-cap which surrounds the plug and the neck, a ring which is attached around the wire-cap and shaped so as to have a central opening providing access from the outside of the cover to the inside of the vessel via the plug, and a cap attached to the ring and shaped so as to close said opening. The cap comprises attachment tabs which are spaced apart from each other along the annular periphery of the opening of the ring and which are clamped between the ring and the wire-cap.

A compression member according to the presently claimed invention is defined in appended claim <NUM>.

According to an example, considered useful for understanding the presently claimed invention, there is provided a compression member for insertion into a pig for transporting a container of biohazardous materials, the compression member comprising a flange maintained in spaced relation with an annulus by pillars; and spaced apart pivotable grip components supported by the annulus and extending downwards from the annulus between respective ones of the pillars towards, but not into contact with, the flange, the pivotable grip components resiliently compressible inwardly against the container when the container is received within the compression member.

In an embodiment, the compression member further comprises a ramp on an outward-facing surface of each of the grip components.

In an embodiment, the compression member further comprises a buttress at the interface between each pillar and the annulus.

In an embodiment, the flange of the compression member further comprises a sloped edge about its periphery for snap retention within the complementary annulus.

In an embodiment, the flange, annulus, pillars and grip components are formed as a unitary structure.

In an embodiment, the compression member is formed of a thermoplastic material.

In drawings that illustrate an embodiment of the invention by way of non-limiting example only:.

A pig <NUM> for transporting a container <NUM> containing a biohazardous product is shown in <FIG>. The advantages of the pig <NUM> are particularly applicable in the case of radiopharmaceuticals, whether in solid or liquid form. However, the pig <NUM> may be configured to be suitable for transporting virtually any type of radiopharmaceutical product, and is also suitable for transporting other types of biohazardous products or substances such as biological pathogens. One or more advantages can be obtained in the use of a pig according to the invention for storing and transporting any kind of biohazardous product where access to the internal (non-protective) container holding the biohazardous product is required intermittently. The embodiments of the invention described herein are for purposes of example only and the invention is not intended to be limited to the specific embodiments described.

A biohazardous materials container, for example a radiopharmaceutical container <NUM> as shown, comprises a bottle <NUM> and a closure <NUM> for sealing the bottle <NUM>. The container <NUM> may be made of any suitable material, typically plastic or glass depending upon the type and form of radiopharmaceutical contained therein. For example in the embodiment shown in <FIG> the container <NUM> is a glass vial containing a liquid radiopharmaceutical <NUM>.

The cap <NUM> of the pig <NUM> is configured <NUM>) to allow the container <NUM> to be removed from the body <NUM> of the pig <NUM> while secured to (and thus in part shielded by) the cap <NUM>, and <NUM>) to allow the closure <NUM> to be removed from the bottle <NUM> without opening the pig <NUM> in order to avoid exposing the user to the radioactive contents of the product, as described in detail below. In the embodiment shown the bottle <NUM> comprises a bead 12a about its neck, and the closure <NUM> is a stopper-type closure having a body 14a which closes the neck of the bottle <NUM> in an interference fit. In other containers <NUM> the closure may be clinched to the neck of the bottle <NUM>. In the case of liquids the closure <NUM> is typically provided with a generally central septum 14b (see <FIG>) for penetration by a syringe in order to extract the contents of the bottle <NUM>.

The pig <NUM> in the embodiment illustrated a radiopharmaceutical pig <NUM>, comprises a cylindrical body <NUM> and a complementary cylindrical cap <NUM> for attachment to the body <NUM>.

The components of the radiopharmaceutical pig <NUM> shown may be formed from a radioactivity-shielding material such as lead or tungsten, or may be formed from any suitably strong metal or plastic. In the case of the radiopharmaceutical pig <NUM> shown the portions surrounding the compartment <NUM> are lined with a suitably radioactivity-resistant liner formed from a material such as lead or tungsten. If the pig is used to transport toxins, biological pathogens or other nonradioactive products or substances, the compartment <NUM> may be hermetically sealed when the pig <NUM> is closed to prevent exposure to the ambient environment.

The body <NUM> comprises a recess concentric with and overlying the radiopharmaceutical container compartment <NUM>, forming a throat <NUM> which provides projecting cams <NUM> along its interior wall, as best seen in <FIG>. The cap <NUM> comprises a two-stage closure for sealing the biohazardous container compartment <NUM> against radioactivity leakage.

The first body closure stage comprises an outer collar 30a that fits within the throat <NUM> of the body, which when secured to the body <NUM> extends into and sealingly engages with the throat <NUM>. In the embodiment illustrated the collar 30a comprises a projecting collar neck portion <NUM> that provides external projecting cams 31a, best seen in <FIG>, which are complementary to the cams <NUM> about the throat <NUM> and positioned so that when the neck <NUM> of the collar 30a is secured into the throat <NUM> above the biohazardous materials container compartment <NUM> by partial (e.g. <NUM> degree) rotation in a 'bayonet' connection, the lower edge 31b of the neck <NUM> sealingly engages against the floor <NUM> of the throat <NUM> around its periphery and prevents radioactivity from escaping around the collar 30a.

The collar 30a comprises an orifice <NUM> extending through the body and neck <NUM> of the collar 30a, in communication with the biohazardous materials container compartment <NUM>. The upper portion of the orifice <NUM> provides a larger diameter and projecting cams 31d (see <FIG>) disposed about its interior surface, for receiving the cap closure 30b as described below. The orifice <NUM> narrows as it approaches the neck <NUM>, creating a ledge 31c at an intermediate point for sealing engagement by the cap closure 30b. In some embodiments the narrower lower portion of the orifice <NUM> is adapted to receive a compression, or "grip", member <NUM> that functions to grip closure <NUM> as will be described below.

The cap closure 30b provides a cap closure neck <NUM> that fits into the orifice <NUM>. In the embodiment illustrated the cap closure 30b comprises a projecting closure neck portion <NUM> that provides external projecting cams 33a, best seen in <FIG>, that are complementary to the cams 31d and positioned so that when the closure neck <NUM> is secured into the orifice <NUM> by partial (e.g. <NUM> degree) rotation in a 'bayonet' connection, the lower surface 33b of the neck <NUM> sealingly engages against the ledge 31c of the orifice <NUM> around its periphery and prevents radioactivity from escaping through the orifice <NUM>.

The cap closure 30b attaches to the collar 30a in a compressive motion, such that the container closure <NUM> is gripped by the annulus <NUM> of the closure 30b. Although a bayonet fitting arrangement is a particularly convenient means of compressively attaching the cap closure 30b to the collar 30a, these components may be attached together in any other suitable manner that provides a compressive motion of the cap closure 30b relative to the collar 30a, for example by threading. Also, in the embodiment shown the body <NUM> and cap <NUM> have a cylindrical exterior, which simplifies the provision of a bayonet connection, however any other convenient configuration may be used with a closure mechanism suitable for substantially preventing leakage of radioactivity from the pig <NUM>.

To improve the gripping action of the cap closure 30b compressed against the collar 30a, the somewhat resilient grip <NUM> may be disposed in the orifice. In the embodiment shown the grip <NUM> comprises a flange <NUM> supporting spaced apart fingers <NUM> that form a circle complementary to the inner wall of the annulus <NUM>, as best seen in <FIG>. The fingers <NUM> each have a substantially vertical component extending upwards from the flange <NUM> and a substantially horizontal component extending inwards from the end of the substantially vertical component thereby to overlap the container closure <NUM> to a degree as illustrated. In this embodiment the annulus <NUM> projects from the lower edge 33b of the closure neck <NUM> into the narrower portion of the orifice <NUM> in a clearance fit, as shown in <FIG>, and instead of engaging the container closure <NUM> directly the annulus <NUM> defines a recess 35a adapted to engage the grip <NUM>, best seen in <FIG>. In particular, when the cap closure 30b is attached to the collar 30a the annulus <NUM> compressively engages the fingers <NUM> of grip <NUM> to collapse the fingers <NUM> toward each other against their tendency to remain substantially vertical (that is, to tilt fingers <NUM> inwardly against their bias) and grip the container closure <NUM>, as shown in <FIG>. When the cap closure 30b is disengaged from the collar 30a the annulus <NUM> does not compress the fingers <NUM> inwards against the container closure <NUM> thus permitting fingers <NUM> to spread apart again as per the resiliency to remain substantially vertical (that is to enable fingers <NUM> to tilt outwardly again to the substantially vertical orientation to which they are biased) enabling the top of container closure <NUM> to be more exposed through the orifice.

The grip <NUM> may be formed from a semi-compressible material such as plastic (such as a thermoplastic such as Delrin™ available from Dupont Corporation of Wilmington, Delaware, U. or polypropylene) or silicone, and has an external profile allowing it to fit snugly within the recess 35a of the annulus <NUM>, and an internal profile allowing the closure <NUM> of the biohazardous container <NUM> to fit snugly within the grip <NUM>, as shown in <FIG>. The grip <NUM> may be provided with a pattern of openings, increasing the overall compressibility of the grip <NUM> and reducing its cost.

The lower end of the annulus <NUM> has a slightly diverging wall which is drawn downwardly against the grip <NUM> as the collar 30a is engaged to the body <NUM>, compressing the grip <NUM> slightly. The grip <NUM> thus provides a buffer between the incompressible interior surface of the annulus <NUM> and the container closure <NUM>, which in the example shown is a stopper engaged with the neck of the container <NUM> in an interference fit thereby capping the container <NUM>. This both allows the closure <NUM> to be held securely by the cap <NUM> and, where the biohazardous container <NUM> is made of glass, potentially avoids breakage. As in the embodiment illustrated the grip <NUM> may be frictionally and secured to the collar by lugs <NUM> projecting into complementary bores 31e formed in the lower edge of the neck <NUM> of the collar 30a thereby to inhibit rotation and translational exit from the bores 31e. In other embodiments (not shown) the periphery of the flange <NUM> may snap-fit onto the recess <NUM> formed in the bottom surface of the collar 30a (see <FIG>), for example by proving a slight reverse-chamfer in the recess wall so it converges toward the lower limit of the collar 30a, retaining the flange <NUM>, which avoids having to line up the lugs <NUM> with bores 31e.

The grip <NUM> can be supplied in a single-use sterile package for the plastic piece, or can be pre-loaded to vial and both sterilized together. Different sizes of vial would dictate a corresponding change in the diameter of the compartment <NUM>, but such vials tend to have a standard neck and same septum circumference and in such cases the same size of cap <NUM> and grip <NUM> can be used.

In the case of the radiopharmaceutical pig <NUM> shown, the assembled cap <NUM> and body <NUM> thus provide a radioactively-shielded compartment <NUM>, for shielding the radioactive contents of the radiopharmaceutical container <NUM> contained when sealed into the radiopharmaceutical compartment <NUM>. In the embodiment shown the compartment <NUM> is defined by a cavity formed largely within the body <NUM> which is sized to receive the bottle <NUM> in a close fit, preferably a clearance fit but alternatively an interference fit, however the compartment <NUM> may be formed by defined by suitably sized and aligned adjoining cavities formed respectively in the body <NUM> and the cap <NUM>.

Thus, when the closure remover <NUM> is seated over the compartment <NUM> it closes the cap opening <NUM> in order to radioactively seal the radiopharmaceutical compartment <NUM>. Also, when the cap <NUM> is removed from the body <NUM> it is possible to manipulate the sealed container <NUM> by handling only the cap <NUM>, thereby shielding the technologist's extremities from radiation.

To preserve a radiopharmaceutical pill (not shown), the bottle <NUM> optionally may be provided with fins (not shown) that confine the pill <NUM> to an axially central portion of the container <NUM> and thus reduce the amount of pill surface touching the bottle <NUM>.

In use of the embodiment shown, a radiopharmaceutical liquid or solid material (e.g. a pill) is placed into the bottle <NUM> using conventional techniques and equipment to avoid exposure to staff. A radioisotope solution <NUM> in a glass bottle <NUM> is illustrated in <FIG>. In the case of a liquid radiopharmaceutical product the vial typically arrives already filled with the radioactive liquid. The closure <NUM> may optionally be designed to accommodate a desiccant or other product-stability material or method (not shown) in order to control the humidity within the container <NUM>.

The closure <NUM> is applied to the container <NUM> which is then placed into the container compartment <NUM>. The cap <NUM> is placed on the body <NUM> of the pig <NUM> and rotated in the closing direction to engage the cams <NUM>, 31a and to seal the cap <NUM> tightly to the body <NUM>, confining radioactivity from the pill <NUM> within the container compartment <NUM>.

The pig <NUM> can then be transported to the patient's facility for administration of the biohazardous material, in the example shown a liquid radioisotope.

When the pig <NUM> arrives at the destination, the pig <NUM> is taken to a room designed to contain the radioactivity and protect staff, as is conventional. The technician grasps the collar 30a and ensures that the cap closure 30b is fully rotated in the direction that locks it to the collar 30a, clockwise in the embodiment illustrated as indicated by the `pick up vial' arrow in <FIG>. This lodges the container closure <NUM> into the annulus <NUM>, where a grip <NUM> is used squeezing the grip <NUM> against the container closure <NUM>, to lock the container <NUM> to the cap <NUM>.

The technician then grasps the body <NUM> and rotates the cap <NUM> collar (30a and cap closure 30b together) to remove the cap <NUM> from the body <NUM> with the container closure <NUM> lodged in the annulus <NUM> (or where a grip <NUM> is used, in the grip <NUM>), and lifts the cap <NUM> off the body <NUM> as shown in <FIG>.

Where the biohazardous material is a liquid and the cap <NUM> of the bottle (typically a vial) <NUM> provides a septum 14b or other entry orifice for a syringe (not shown), the closure 30b can be removed from the collar 30a to expose the top of the container closure <NUM> and allow the insertion of a syringe without releasing the vial from the collar 30a. A tungsten insert <NUM>, for example as shown in <FIG>, may be provided to replace the cap closure 30b. The insert <NUM> comprises a head <NUM> and a neck <NUM> that fits into the orifice <NUM> in the collar 30a. In the embodiment illustrated the neck <NUM> of the insert <NUM> provides external projecting cams <NUM> that are complementary to the cams 31d and positioned so that when the insert <NUM> is secured into the orifice <NUM> by partial (e.g. <NUM> degree) rotation in a 'bayonet' connection, the lower surface of the neck <NUM> sealingly engages against the ledge 31c of the orifice <NUM> around its periphery. The syringe may be inserted into the septum through an injection port <NUM> extending fully through the insert <NUM> in axial alignment with the compartment <NUM> of the body <NUM>. In this embodiment, the injection port <NUM> is cylindrical and has a single diameter throughout its length. The insert <NUM> provides enhanced radiation protection while dispensing from multi dose vial (stock) due to its smaller-diameter injection port <NUM> through a head <NUM> and neck <NUM> of tungsten, as well as guidance for a syringe to be inserted centrally into the container <NUM> through the container closure <NUM>. In alternative embodiments, the injection port may be frustoconical.

An alternative tungsten insert 60A is shown in <FIG>. In this embodiment, tungsten insert 60A has an injection port 68A that has an upper portion 68A_U extending partway through the insert 60A (substantially the height of head 62A) with a larger maximum diameter than does injection port <NUM> of insert <NUM>, and a lower portion 68A_L extending from the upper portion 68A_U through the rest of the insert 60A (substantially the height of neck 64A) with a smaller diameter (in this embodiment, similar to the diameter of injection port <NUM> of insert <NUM>). This larger diameter of the upper portion 68A_U permits the ease of insertion and angling of multiple outlet or inlet conduits (such as other syringes or needles thereof) while also permitting a user sufficient room to insert a syringe for withdrawing contents of the container <NUM>. It will be noted that the thickness of a tungsten neck 64A is suitable for sufficient radiation protection in many instances such that there need not be significant concern about the head 62A accommodating the larger upper portion 68A_U of the injection port 68A rather than providing the additional shielding. In this embodiment, each of upper portion 68A_U and lower portion 68A_L are cylindrical. However, in an alternative embodiment, one or both of upper portion 68A_U and lower portion 68A_L of injection port 68A may be frustoconical in shape. Still further, in another alternative embodiment, the upper and lower portions 68A_U and 68A_L of injection port 68A may be replaced by a single, frustoconical injection port with the widest end having a diameter similar to that shown in Figure 18B at the upper end of the insert 60A.

The container <NUM> can be released by grasping the collar 30a and fully rotating the cap closure 30b in the direction that unlocks it from the collar 30a, counter-clockwise in the embodiment illustrated as indicated by the `release vial' arrow in <FIG>.

In use, the biohazardous material is placed in the container <NUM> by the manufacturer, placed in the container compartment <NUM> of the pig <NUM>, and shipped to the destination. A technician at the destination removes the cap <NUM> with the container <NUM> attached, moves the container <NUM> to a dose calibrator (not shown) and, while grasping the collar 30a, rotates the cap closure 30b to release the container closure <NUM> and (typically using tongs) insert the container <NUM> into the dose calibrator to measure (assay) amount of radioactivity. The bottle <NUM> is vented in the dose calibrator, if required (typically only in the case of radioiodine capsules).

The container <NUM> can then be re-sealed and the closure <NUM> reinserted into the grip <NUM>. The technician while grasping the collar 30a rotates the cap closure 30b in the locking direction to secure the container closure <NUM> to the grip <NUM>. The cap <NUM> is then replaced in the manner described above, and delivered to the patient for administration by a qualified professional.

At the patient site, in the case of a liquid the technician removes the cap closure 30b from the collar 30a and secures the insert <NUM> or insert 60A to the collar 30a by interlocking cams <NUM> and <NUM> in a bayonet fashion. The technician then inserts a syringe through the orifice <NUM> and the septum 14b to aspirate the liquid <NUM> from the bottle <NUM>. The insert <NUM> or 60A can then be removed and the cap closure 30b replaced on the collar 30a to shield the residual radioactivity in the bottle <NUM>.

The pig according to the invention can be used for any type of radioisotope, including those used for so-called "theranostics. " Although tungsten shields gamma rays effectively, optionally a Lucite (Trademark) or Aluminum tube can be used to line the compartment <NUM> for materials having high beta emissions, for example to shield beta emissions from a radioisotope such as I-<NUM>. Bremsstrahlung occurs as beta particles strike a dense material like tungsten or steel, and the Lucite tube thus serves as a 'pillow' to reduce or eliminate bremsstrahlung x-rays.

<FIG> is a front perspective view of a pig <NUM> according to an alternative embodiment and a handle assembly <NUM> for the pig <NUM>. In this embodiment, pig <NUM> is very similar to pig <NUM> described above, but the outer dimensions (in this embodiment, diameter) of the body <NUM> of pig <NUM> is larger than the outer dimensions of the collar 30a of the cap <NUM> of pig <NUM> and thereby presents a ledge extending laterally outwards from below collar 30a to the periphery of body <NUM>.

As will be described, handle assembly <NUM> is configurable for carrying pig <NUM>, for supporting pig <NUM> during extraction of contents of bottle contained within, and for inhibiting unintended removal of cap <NUM> particularly during transportation of pig <NUM>.

In this embodiment, handle assembly <NUM> includes an upper collar <NUM> and a lower collar <NUM> maintained in a fixed spaced relationship by two struts 330a, 330b located opposite each other with respect to pig <NUM> and extending between the upper collar <NUM> and the lower collar <NUM>.

Upper collar <NUM> includes a ring <NUM> with a central opening <NUM> and an outer diameter that is slightly larger than the outer diameter of body <NUM> of pig <NUM>, and a wall <NUM> depends downwards at right angles to the ring <NUM> about its periphery. The diameter of the central opening <NUM> is slightly larger than the diameter of collar 30a so that the upper collar <NUM> can be associated with the body <NUM> of pig <NUM> by being placed atop the body <NUM> such that the ring <NUM> of upper collar <NUM> directly faces the ledge of body <NUM> with the wall <NUM> of the upper collar <NUM> extending down a short distance along the exterior of body <NUM>.

In this embodiment, lower collar <NUM> is identical to upper collar <NUM>, but is oriented upward thereby to be associated with the bottom of body <NUM> by receiving the bottom of body <NUM> within its peripheral wall <NUM>. It will be understood that, while upper and lower collars <NUM>, <NUM> are identical in this embodiment, the lower collar <NUM> in this embodiment does not really need its own central opening <NUM> to fulfil its function since the bottom of body <NUM> does not have a corresponding feature.

In this embodiment, upper collar <NUM> and lower collar <NUM> are made of Delrin™.

Each of struts 330a, 33b is connected at a proximate end to the wall <NUM> of upper collar <NUM> and at a distal end to the wall <NUM> of lower collar <NUM>. In this embodiment, channels 318a, 318b, 328a and 328b in the outer face of the peripheral walls <NUM>, <NUM> of each of upper and lower collars <NUM>, <NUM> receives corresponding proximate and distal ends of a strut 330a or 330b, and the proximate and distal ends of the strut 330a or 330b are locked within the corresponding channels 318a, 318b, 328a, 328b with fasteners F. In this way, the upper and lower collars <NUM>, <NUM> contain body <NUM> of pig <NUM> such that it is not separable from the upper and lower collars <NUM>, <NUM> unless these fasteners F are removed.

Each of struts 330a, 330b has an outward-facing threaded aperture along its outward-facing surface and intermediate its proximate and distal ends for receiving the threaded end of a corresponding knob 340a or 340b via a corresponding washer 341a, 341b. A U-shaped handle <NUM> has elongate arms 352a and 352b each depending from a cross member <NUM>, and each of the elongate arms 352a, 352b has therethrough an elongate channel 356a, 356b. The handle <NUM> is connectable to the struts 330a, 330b by passing knob 340a, 340b through a respective elongate channel 356a, 356b threading the knobs 340a, 340b into its corresponding threaded aperture in the strut 330a, 330b. In this configuration, if both of the knobs 340a, 340b are not fully threaded into corresponding threaded apertures, they do not compress respective arms 352a, 352b against the corresponding strut 330a, 330b, such that the channel 356a, 356b and correspondingly the handle <NUM> can be both freely rotated about and freely slid along the corresponding knob 340a, 340b while remaining generally connected to the rest of the handle assembly <NUM>. In this way, the handle <NUM> can be moved between various rotational and extensional orientations with respect to the body <NUM> of pig <NUM>. If any or both of the knobs 340a, 340b are tightened so as to press the arms <NUM>, 352b against the struts 330a, 330b, the handle is held frictionally in position and is thereby prevented from rotating or sliding with respect to the struts 330a, 330b. It is preferred that the operator tighten both knobs 340a, 340b when intending to maintain the handle <NUM> in a particular fixed position with respect to the body <NUM>, since the body <NUM> and the closure <NUM>, being formed with dense, thick walls of tungsten, can be quite heavy.

<FIG> is a perspective view of the pig <NUM> and handle assembly <NUM> of <FIG>, with the handle <NUM> having been slid along knobs 340a, 340b to a position in which the cross member <NUM> is resting atop the cap <NUM> of the pig <NUM>. In this position, the handle <NUM> serves to further inhibit removal of the cap <NUM> thereby providing an extra measure of security for transportation. Cap <NUM> cannot be lifted from body <NUM> while handle <NUM> is in this position (and knobs 340a, 340b are tightened), even if it is rotated somewhat with respect to body <NUM>. In this respect, body <NUM> can be rotated somewhat within collars <NUM> and <NUM> if urged to do so either manually or during jostling in transportation, because, while handle assembly <NUM> encapsulates body <NUM>, it is not fastened directly to it in this embodiment. The surface of cross member <NUM> facing the top of cap <NUM> is generally smooth such that cap <NUM> is free to rotate along with body <NUM> even when handle <NUM> is in the position shown in <FIG>. In this way, handle <NUM> is not easily positioned with respect to cap <NUM> in a way that will result in handle <NUM> inadvertently loosening cap <NUM>. In an alternative embodiment, body <NUM> is non-cylindrical such as square-based and handle assembly <NUM> is of a complementary shape, thus inhibiting any rotation of one with respect to the other.

<FIG> is a perspective view of the pig <NUM> and handle assembly <NUM> of <FIG>, with the handle <NUM> having been slid and rotated along knobs 340a, 340b to a position in which the cross member <NUM> is underneath and spaced from the bottom of lower collar <NUM>. In this position, handle <NUM> can be used to hold pig <NUM> either manually or on a hook (not shown) in preparation for removal of the contents of pig <NUM>.

<FIG> is an exploded perspective view of the handle assembly <NUM> for the pig <NUM> in isolation. In this view, compression washers 341a and 341b, in this embodiment formed of rubber, are viewable. These are positioned adjacent to the threaded apertures in struts 330a, 330b for knobs 340a and 340b in order to improve their grip against handle arms 352a, 352b via their channels 356a, 356b, particularly during jostling in transport but also for handling.

<FIG> is a perspective top view of an alternative compression member, or grip <NUM>, for assisting in securing a container closure <NUM> to the cap <NUM>. In the embodiment shown the grip <NUM> comprises a flange <NUM> supporting a sleeve <NUM> that is integrated with and encompasses spaced apart fingers <NUM> that form a circle complementary to the inner wall of the annulus <NUM>. The fingers <NUM> each have a substantially vertical component extending vertically with the sleeve <NUM> from the flange <NUM> and a substantially horizontal component extending inwards with the sleeve <NUM> from the end of the substantially vertical component thereby to overlap the container closure <NUM> to a degree in a similar manner as has been described above with respect to grip <NUM>. Extending between each pair of fingers <NUM> of grip <NUM>, however, is a respective web <NUM> integrated also with sleeve <NUM> that is made of a material as will be described that permits flexibility of the fingers <NUM> inwards and outwards and accordingly towards and away from each other, while providing a more unitary overall structure for surrounding a container closure <NUM>.

In this embodiment, flange <NUM> is formed of a semi-compressible material such as plastic (such as a thermoplastic such as Delrin™ or polypropylene). In this embodiment, flange <NUM> is not circular, but is instead substantially a square with significantly rounded corners <NUM>. Furthermore, flange <NUM>, as best seen in the side elevation view of <FIG>, has a sloped edge S spanning the entire periphery of the flange <NUM>. Both the rounded corners <NUM> and the sloped edge S contribute to permit flange <NUM> to be snapped into, and retained frictionally within, corresponding sloped structure at a correspondingly sloped lower edge of the neck <NUM> of collar 30a of the cap <NUM>. While flange <NUM> is retained within such a correspondingly sloped lower edge of neck <NUM>, when desired, flange <NUM> may be manually snapped out of the lower edge of neck <NUM> of collar 30a for disposal of grip <NUM> and a new grip <NUM> snapped into place as a replacement. It will be noted that, unlike grip <NUM>, grip <NUM> does not have posts <NUM>. However, in an alternative embodiment the combination of such posts and the sloped edge S of flange <NUM> may be employed.

In this embodiment, fingers <NUM> are formed of the same rigid material as flange <NUM>, while sleeve <NUM> and webs <NUM> are formed of a more flexible but resilient material such as silicone that is fused at its boundaries with flange <NUM> and fingers <NUM>.

While a grip <NUM> of two integrated materials exhibiting the two different properties (rigid and flexible) can be very useful, it can be expensive to manufacture. As such, in alternative embodiments grip <NUM> may be manufactured from a single material for the sleeve <NUM>, fingers <NUM> and webs <NUM> with the relative rigidity and flexibility produced through differing thicknesses at different points throughout the grip <NUM> of the one material rather than necessarily from different materials. For example, the interfaces between the webs <NUM> and the fingers <NUM> and flange <NUM> may incorporate less of the material than between the fingers <NUM> and the flange <NUM> thereby to permit webs <NUM> to be flexed relative to the flange <NUM> and fingers <NUM> more than the fingers <NUM> can flex relative to the flange <NUM>. In this way, the resilience of fingers <NUM> with respect to flange <NUM> can be maintained while reducing the rigidifying effect of the webs <NUM> between the fingers <NUM>.

<FIG> is a top plan view of the grip <NUM>, <FIG> is a bottom plan view of the grip <NUM>, <FIG> is a perspective bottom view of the grip <NUM>, <FIG> is a perspective top view, partially sectioned, of the grip <NUM>, <FIG> is a perspective bottom view, partially sectioned, of the grip <NUM>, <FIG> is another perspective top view, partially sectioned below the horizontal components of the sleeve <NUM>, the fingers <NUM> and the webs <NUM>, of the grip <NUM>, <FIG> is another perspective bottom view, partially sectioned, of the compression member of <FIG>.

The radiopharmaceutical pigs <NUM> and <NUM> described and illustrated are particularly suitable for transporting radioactive substances such as liquid and solid radiopharmaceuticals due to the radioactivity-shielding character of the container <NUM>, but can be adapted to transport other biohazardous products and materials without the use of radioactivity shielding by hermetically sealing the container <NUM>.

Various embodiments of the present invention comprising been thus described in detail by way of example, it will be apparent to those skilled in the art that variations and modifications may be made without departing from the invention. The invention includes all such variations and modifications as fall within the scope of the appended claims.

For example, while embodiments described herein involve the compartment <NUM> of body <NUM> or body <NUM> being dimensioned to receive only a container of the biohazardous material, embodiments are contemplated in which the compartment <NUM> is dimensioned to receive a container in addition to a sponge, such as a cellulose sponge, for physically absorbing liquid originally contained within the received container should it escape from the container during transportation or other handling. Some regulators require that there be provided a quantity of sponge that is capable of absorbing twice the volume of liquid to be contained within the container. Such a cellulose sponge may be formed as a slab and positioned at the bottom of compartment <NUM> underneath the container, but may alternatively be formed as a cup having a bottom and a sleeve dimensioned to receive the container and, in turn, to be received within compartment <NUM>. The cellulose sponge slab or sleeve would be a consumable.

Furthermore, while handle assembly depicted and describe herein has two struts, alternatives are contemplated having more than two struts, or other structures for encapsulating the body within the handle assembly.

Still further, very thin layers of rubber or other frictional material may be placed at the interfaces between collar 30a and cap closure 30b and collar 30a and body <NUM> in order to resist inadvertent relative movements when being transported to thereby resist inadvertent exposure to the contents of the container <NUM>.

<FIG> is a perspective top view of another alternative compression member, or grip <NUM>, for assisting in securing the container closure <NUM> to the cap <NUM>. In the embodiment shown the grip <NUM> comprises a flange <NUM> being maintained in a spaced relation with an annulus <NUM> by pillars <NUM> extending between the annulus <NUM> and the flange <NUM>. Spaced-apart pivotable grip components <NUM> are supported by annulus <NUM> and extend downwards from the annulus <NUM> between respective pillars <NUM> towards, but not into contact with, the flange <NUM>. The pivotable grip components <NUM> are resiliently compressible inwardly against a container <NUM> and its closure <NUM> by compressive engagement of a complementary annulus <NUM> of the pig <NUM> into which the compression member <NUM> is dimensioned to be inserted, since the ends of the grip components <NUM> terminate between the annulus <NUM> and the flange <NUM> and are thus unattached. The outward-facing sides of the pivotable grip components <NUM> each incorporate ramps <NUM> that engage the complementary annulus and progressively urge the pivotable grip components <NUM> inwards towards a container <NUM> as grip <NUM> is, along with a container <NUM>, urged further into annulus <NUM>. Pillars <NUM> include additional buttresses <NUM> at their interfaces to flange <NUM> in order to strengthen their interconnection.

The pivotable grip components <NUM> and pillars <NUM> encircle a closure <NUM> and part of a neck <NUM> of a container <NUM> received within the interior of flange <NUM>. This interaction with a closure <NUM> and part of a neck <NUM> of a container <NUM> is similar to that shown between grip <NUM> and container <NUM> in <FIG>, except that, with grip <NUM>, fingers <NUM> overlie the closure <NUM> whereas with grip <NUM>, annulus <NUM> overlies the vial cap and the compressible grip components <NUM> do not.

Also, because pivotable grip components <NUM> depend from annulus <NUM> between the pillars <NUM> only partway, compression member <NUM> is, via the pivoting of the pivotable grip components <NUM>, therefore able to apply more even force along the surface of a crimped vial closure <NUM>. This provides an improved grip, and improved handling and radiation safety. In use, the grip <NUM> is placed atop of a crimped-top of a vial, and the corresponding portions of the pig in the annulus <NUM> of the pig that interact with the ramps <NUM> along the outward-facing sides of the pivotable grip components <NUM> as the compression member <NUM> (along with the container <NUM>) are inserted therein cause the pivotable grip components <NUM> to move inwardly to grip the closure <NUM> of the container <NUM> and, in some embodiments, also contact the glass of the container <NUM>. Grip <NUM> also serves as a spacer for between these portions of the container <NUM> and the pig <NUM>.

In this embodiment, the above-described components of grip <NUM> are formed of a semi-compressible material such as plastic (such as a thermoplastic such as Delrin™ or polypropylene). In this embodiment, grip <NUM> is a single-piece component - a unitary structure - formed by machining. Furthermore, in this embodiment, flange <NUM> is not circular, but is instead substantially a square with significantly rounded corners <NUM>. Furthermore, flange <NUM>, as best seen in the side elevation view of <FIG>, has a sloped edge S spanning the entire periphery of the flange <NUM>. Both the rounded corners <NUM> and the sloped edge S contribute to permit flange <NUM> to be snapped into, and retained frictionally within, corresponding sloped structure at a correspondingly sloped lower edge of the neck <NUM> of collar 30a of the cap <NUM>. While flange <NUM> is retained within such a correspondingly sloped lower edge of neck <NUM>, when desired, flange <NUM> may be manually snapped out of the lower edge of neck <NUM> of collar 30a for disposal of grip <NUM> and a new grip <NUM> (or grip <NUM>, or grip <NUM>) snapped into place as a replacement. It will be noted that, unlike grip <NUM>, and like grip <NUM>, grip <NUM> does not have posts <NUM>. However, in an alternative embodiment the combination of such posts and the sloped edge S of flange <NUM> may be employed.

<FIG> is a side elevation view of the compression member <NUM> of <FIG>. <FIG> is a top plan view of the compression member <NUM> of <FIG>. <FIG> is a perspective top view, partially sectioned, of the compression member <NUM> of <FIG>. <FIG> is a perspective bottom view of the compression member <NUM> of <FIG>.

Claim 1:
A compression member (<NUM>) for insertion into a pig (<NUM>) for transporting a container (<NUM>) of biohazardous materials, the compression member (<NUM>) comprising:
a flange (<NUM>) maintained in spaced relation with an annulus (<NUM>) by pillars (<NUM>); and
spaced apart pivotable grip components (<NUM>) supported by the annulus (<NUM>) and extending downwards from the annulus (<NUM>) between respective ones of the pillars (<NUM>) towards, but not into contact with, the flange (<NUM>),
characterised in that the pivotable grip components (<NUM>) are configured to be biased to a substantially vertical orientation between the pillars (<NUM>) and resiliently compressible inwardly by the pig (<NUM>) against the bias and against the container (<NUM>) such that the pivotable grip components (<NUM>) are configured to grip the container (<NUM>) while both the container (<NUM>) is received within the compression member (<NUM>) and the compression member (<NUM>) is inserted into the pig (<NUM>).