CA2934266A1 - Bio-hazardous material transporting pig with safety container closure remover - Google Patents

Abstract

A pig for transporting a container containing a hazardous product. The pig comprises a base and a cap for attachment to the base defining a hermetically sealed compartment, in the case of a radiopharmaceutical product, a radioactively-shielded compartment. The cap comprises a cap opening in which a closure remover is rotatably disposed. The closure remover comprises an axial passage for receiving a closure projecting member and supporting a pin for retractably extending into the closure projecting member aperture.
The pin can be retracted to lodge the pin in the closure projecting member so that rotation of the closure remover removes the enclosure from the container without opening the pig.

Description

BIO-HAZARDOUS MATERIAL TRANSPORTING PIG WITH
SAFETY CONTAINER CLOSURE REMOVER
FIELD OF THE INVENTION
[0001] This invention relates to radiopharmaceuticals. In particular this invention relates to a pig for storing and transporting bio-hazardous products and substances.
BACKGROUND OF THE INVENTION
[00021 The transportation of bio-hazardous 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.
[00031 For example, radioactive pharmaceutical products, 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.
[0004] Unless properly shielded, such products become a radiation hazard for individuals handling the product. The container in which the radiopharmaceutical is stored before use is typically made of plastic, for example polyethylene, which has no radioactivity-shielding properties. Therefore the storage, transportation and administration of radiopharmaceuticals is carefully controlled by rules designed to regulate the handling of such materials in a manner that reduces the radiation hazard.
[0005] For example, radioiodine pills or capsules are an ingestible radiopharmaceutical 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. 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, is placed by the manufacturer into the plastic container to be shipped to a qualified facility for administration to a particular patient or patient category. This represents the first

- 2 -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.
[0006] The container containing the radiopharmaceutical pill or capsule must then be shipped to the destination hospital or clinic for administration to the patient. To effect this safely, the pill container is dropped into a radioactivity-shielding container commonly known as a "pig" for interim storage and delivery to the destination.
[0007] 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 US Patent No. 6,586,758 issued July 1, 2003 to Martin, which is incorporated herein by reference in its entirety.
[0008] 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, however other types of radiopharmaceuticals (for example liquids) may be contained within a syringe, ampule (bottle or other glass container) or the like, in which case the radiopharmaceutical compartment would be dimensioned accordingly.
[0009] 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, syringe or the like is sealed in the radiopharmaceutical container compartment of the pig.

- 3 -[0010] 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 second opportunity for exposure to the radioactive contents of the radiopharmaceutical container, in the presence of hospital or clinic staff. The technologist must transfer the radioiodine (for example, 1311) to a Dose Calibrator to assay (measure) the activity of the capsule, which must be within 10% of prescribed activity. After recording the assay, the technologist must retrieve plastic container containing the capsule 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.
[0011] 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.
[0012] However, the venting and assaying steps of the transportation process can present an unnecessary 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.
[0013] There is accordingly a need for a device 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.

- 4 -BRIEF DESCRIPTION OF THE DRAWINGS
[0014] In drawings that illustrate an embodiment of the invention by way of non-limiting example only, [0015] Figure 1 is a side elevation of a radiopharmaceutical pig containing a radiopharmaceutical container.
[0016] Figure 2 is a top plan view of the embodiment of Figure 1.
[0017] Figure 3 is a cross-sectional elevation of the embodiment of Figure 1 taken along the line 3-3 in Figure 2.
[0018] Figure 4 is a cross-sectional elevation of the embodiment of Figure 1 taken along the line 4-4 in Figure 2 [0019] Figure 5 is a perspective view of a closure for the radiopharmaceutical container.
[00201 Figure 6 is a perspective view of a closure remover component of the pig.
[0021] Figure 7 is a perspective view of a cap for the radiopharmaceutical container.
[0022] Figure 8 is a perspective view of a bottle for the container.
[00231 Figure 9 is a perspective view of the assembled pig.
DETAILED DESCRIPTION OF THE INVENTION
[0024] The invention relates to a pig 20 for transporting a container 10 containing a bio-hazardous product. The radiopharmaceutical container 10 comprises a bottle 12 and a closure 14 for sealing the bottle 12. The closure 14 is configured to co-act with the pig 20, in particular the closure remover 34, to allow the closure 14 to be removed from the bottle 12 without opening the pig 20 and exposing the user to the radioactive contents of the product, as described in detail below.

- 5 -[00251 The invention will be described in the context of a radiopharmaceutical product, in particular a radioiodine pill 2, as a non-limiting example of a type of bio-hazardous product for which the pig 20 is a suitable protective device. However, the pig 20 may be configured to be suitable for transporting virtually any type of radiopharmaceutical product, and is also suitable for transporting other bio-hazardous non-radioactive products or substances such as biological pathogens, for example. 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.
[00261 The pig, in the embodiment illustrated a radiopharmaceutical pig 20, comprises a cylindrical base 22 and a complementary cylindrical cap 30 for attachment to the base 20. The cap 30 has threading 30a about its internal rim that is complementary to threading 22a about the external rim of the base 22, so that the cap 30 can be screwed to the base 22 in a tightly-sealed fashion to avoid any substantial leakage of radiation from the pig 20. Alternatively the cap 30 may be formed with exterior threading complementary to interior threading in the base 22 (not shown). Although threading is a particularly convenient method of attaching the cap 30 to the base 22, these components 22, 30 may be attached together in any other suitable manner. Also, in the embodiment shown the base 22 and cap 30 have a cylindrical exterior, which simplifies the provision of a threaded connection, however any other convenient configuration may be used with a closure mechanism suitable for substantially preventing leakage of radioactivity from the pig 20.
[00271 The components of the radiopharmaceutical pig 20 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 20 shown the portions surrounding the compartment 24 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 non-radioactive products or substances, the compartment 24 may be hermetically sealed when the pig 20 is closed to prevent exposure to the ambient environment.

- 6 -[00281 In the case of the radiopharmaceutical pig 20 shown, the assembled cap 30 and base 22 thus provide a radioactively-shielded compartment 24, for shielding the radioactive contents of the radiopharmaceutical container 10 contained when sealed into the radiopharmaceutical compartment 24. In the embodiment shown the compartment 24 is defined by a cavity formed largely within the base 22 which is sized to receive the bottle 12 in a close fit, preferably a clearance fit but alternatively an interference fit, however the compartment 24 may be formed by defined by suitably sized and aligned adjoining cavities formed respectively in the base 22 and the cap 30.
[0029] The closure 14 comprises a projecting member 16 which comprises an aperture 18, for reasons described below. The container 10 may be formed from any suitable material, for example polypropylene as is conventional or another suitable plastic, and the closure 14 is attached to the bottle 12 via a threaded connection so that rotation of the closure 14 relative to the bottle 12 in one direction seals the bottle 12 and in the other direction removes the closure 14. Other types of rotary connection between the closure 14 and the bottle 12, for example a bayonet-type fitting, may also be possible.
[**the threaded connection in Figs 3-4 is inconsistent with the views of the bottle and closure]
[00301 The cap 30 comprises a cap opening 32 disposed concentrically with and in communication with the radiopharmaceutical compartment 24. A closure remover 34 is rotatably disposed within the cap opening 32. The closure remover 34 includes a lower recess 40 defined within the base wall 42, which is seated on top of a circumferential flange 12a extending about the rim of the bottle 12 and preferably also overlaps the top surface of the base 22 about the flange 12a. The base wall 42 comprises a flange 42a disposed within a groove 42b circumscribing the lower rim of the cap opening 32 in a clearance fit, as best seen in Figure 7.
[00311 The closure remover recess 40 is also radioactively-shielded, being either formed from or lined with a radioactivity-shielding material. Thus, when the closure remover 34 is seated over the compartment 24 it closes the cap opening 32 in order to radioactively seal the radiopharmaceutical compartment 24. Also, when the cap 30 is

- 7 -removed from the base 22 it is possible to manipulate the sealed container 10 by handling only the cap 30, thereby shielding the technologist's extremities from radiation.
[0032] The closure remover 34, best seen in Figure 6, comprises an axial passage 36 for receiving the projecting member 16 of the container closure 14 in substantially rotationally fixed relation. In the embodiment shown a collar 46 through which the closure remover 34 extends is rotationally fixed to a cover flange 48 which rotates on top of the cap 30, and rotationally fixed to the closure remover 34 by set screws 47, as best seen in Figure 9. The collar 34 supports a pin 38 which retractably extends transversely into the closure remover 34 as far as axial passage 36, so that when fully extended the tip of the pin 38 projects into the projecting member's aperture 18. This, the pin 38 can be extended to lodge the pin 34 in the projecting member aperture 18, as shown in Figure 3, and retracted to release the closure 14 from the closure remover 34.
Accordingly, when a radiopharmaceutical container 10 is sealed within the radiopharmaceutical compartment 24 of the pig 20, the pin 38 lodges into the aperture 18 of the projecting member 16. The pin 38 is preferably spring-biased to the extended position, and may have a rounded tip as shown so that when the cap 30 is placed over the base 22 and the projecting member 18 of the closure 14 slides into the passage 36, the pin snaps into the aperture 18 without manual assistance.
[00331 The flange 12a circumscribing the bottle 12 is provided with bosses 12b which seat in complementary holes 12c formed in the base, as best seen in Figure 3, to prevent the bottle 12 from rotating within the compartment 24. It will be appreciated that the bottle 12 can be rotationally fixed relative to the compartment 24 in many other ways.
[00341 In use, a radiopharmaceutical pill 2 is placed into the bottle 12 using conventional techniques and equipment to avoid exposure to staff. To preserve the radiopharmaceutical pill 2, the bottle 12 optionally may be provided with fins 12d that confine the pill 2 to an axially central portion of the container 10 and thus reduce the amount of pill surface touching the bottle 12, as shown in Figure 8, in order to reduce exothermic contact of the pill 2 with the wall of the bottle 12. The closure 14 may

- 8 -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 10.
[00351 The container 10 is then placed into the container compartment 24.
The closure projecting member 16 is inserted into the passage 36 in the cap 30 until the tip of the pin 38 locks into the aperture 18. The entry point for the projecting member 16 into the passage 36 may be chamfered as at 36a for easier insertion. The closure 14 is then centred over the bottle 12 and the cap 30 is rotated in the closing direction to seal the cap 30 to the base 22. The body 15 of the closure 14 rises toward the upper limit of the recess 40 and the aperture 18 rises as the cap 30 is screwed to the base 22. This seals the container 10, and at the same time seals the container compartment 24 by lodging the base wall 42 of the closure remover 34 against the surface of the base 22 surrounding the container compartment 24, confining radioactivity from the pill 2 within the container compartment 24.
[0036] The closure 14 is then engaged to the bottle 12 by rotating the closure remover 34 in the sealing direction, threading the closure 14 to the bottle 12. In the embodiment illustrated a slot 50 through the flange 48 overlays an indicator 52, for example a dot printed or etched at the position on top of the cap 30 which indicates when the closure 14 is fully sealed to the bottle 12.
[00371 The pig 20 can then be transported to the patient's facility for administration of the radiopharmaceutical pill 2.
[00381 When the pig 20 arrives at the destination, the pig is taken to a room designed to contain the radioactivity and protect staff, as is conventional. The closure remover 34 is rotated in the removal direction, which removes the closure 14 from the bottle 12. As the closure remover 34 is rotated the closure 14 unscrews from the bottle 12, while the lower flange 42a of the closure remover 34 is vertically constrained by the groove 42b and thus remains seated against the flange 12a of the bottle 12 and the surrounding top surface of the base 22. This causes the body 15 of the closure 14 to rise into the recess 40 in the closure remover 34. The projecting member 16 and aperture 18 in turn rise without

- 9 -dislodging the pin 38, since the vertical span of the aperture 18 is sufficient to accommodate the travel distance of the closure 14 (in relative terms the pin 38 moves toward the other end of the aperture 18). When the cap 30 is released from the base 22, the tip of the pin 38 intruding into the aperture 18 suspends the closure 14 within the closure remover 34, to vent the bottle 12 without requiring any direct human contact with the bottle 12 or closure 14.
1100391 The bottle 12 is vented for the required interval. The container 10 can then be sealed and the cap 30 replaced in the manner described above, again without personnel handling the container 10 or removing the container 10 from the pig 20, and delivered to the patient for administration by a qualified professional. This significantly reduces the potential hazard of exposure to the radiopharmaceutical pill 2 in the radioactivity venting step.
[00401 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 radiopharmaceutical pig 20 described and illustrated is particularly suitable for transporting radioactive substances such as radiopharmaceuticals due to the radioactivity-shielding character of the container 24, but can be adapted to transport other bio-hazardous products and materials without the use of radioactivity shielding by hermetically sealing the container 24. The invention includes all such variations and modifications as fall within the scope of the appended claims.

Claims (6)

CLAIMS:

1. A pig for transporting a container containing a bio-hazardous material, the container comprising a bottle and a closure for the bottle, the closure comprising a projecting member comprising a projecting member aperture, the pig comprising:
a base, a cap for attachment to the base, a sealed compartment defined by the assembled cap and base, for shielding containment of the contents of a container contained within the compartment, the cap comprising a cap opening disposed generally concentrically with and in communication with the compartment, a closure remover rotatably disposed within the cap opening, for closing the cap opening to seal the compartment, the closure remover comprising an axial passage for receiving the projecting member in substantially rotationally fixed relation and supporting a pin for retractably extending into the axial passage and the closure projecting member aperture, such that the pin can be retracted to lodge the pin in the closure projecting member aperture when a container is sealed within the compartment of the pig, whereby rotation of the closure remover removes the enclosure from the container without opening the pig so that the container can be vented by removing and replacing the cap without handling the container or removing the container from the pig.

2. The pig of claim 1 wherein the bio-hazardous product is radioactive and the components forming the container are composed of or lined with a radioactivity-shielding material.

3. A container for use with a pig comprising a base, a cap for attachment to the base, a hermetically sealed compartment defined by the assembled cap and base, for shielding contents of a container contained within the compartment, the cap comprising a cap opening disposed generally concentrically with and in communication with the compartment, and a closure remover rotatably disposed within the cap opening, for closing the cap opening to hermetically seal the compartment, the closure remover comprising an axial passage for receiving the projecting member in substantially rotationally fixed relation and supporting a pin for retractably extending into the axial passage and the closure projecting member aperture, such that the pin can be retracted to lodge the pin in the closure projecting member aperture when a radiopharmaceutical container is sealed within the radiopharmaceutical compartment of the pig, the container comprising a bottle, and a closure for the bottle, the closure comprising a projecting member comprising a projecting member aperture.
whereby rotation of the closure remover removes the enclosure from the container without opening the pig so that the container can be vented by removing and replacing the cap without handling the container or removing the container from the pig.

4. The container of claim 3 wherein the bio-hazardous product is radioactive and the components forming the container composed of or lined with a radioactivity-shielding material.

5. In combination, a container and a pig for transporting the container to protect against exposure to a bio-hazardous material, the container comprising a bottle, and a closure for the bottle, the closure comprising a projecting member comprising a projecting member aperture, the pig comprising a base, a cap for attachment to the base, a hermetically sealed compartment defined by the assembled cap and base, for shielding contents of a container contained within the compartment, the cap comprising a cap opening disposed generally concentrically with and in communication with the compartment, a closure remover rotatably disposed within the cap opening, for closing the cap opening to hermetically seal the compartment, the closure remover comprising an axial passage for receiving the projecting member in substantially rotationally fixed relation and supporting a pin for retractably extending into the axial passage and the closure projecting member aperture, such that the pin can be retracted to lodge the pin in the closure projecting member aperture when a radiopharmaceutical container is sealed within the radiopharmaceutical compartment of the pig, whereby rotation of the closure remover removes the enclosure from the container without opening the pig so that the container can be vented by removing and replacing the cap without handling the container or removing the container from the pig.

6. The combination of claim 5 wherein the bio-hazardous product is radioactive and the components forming the container composed of or lined with a radioactivity-shielding material.