Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Sample mechanical transport means in or for automated...
Reexamination Certificate
1999-12-08
2003-06-03
Warden, Jill (Department: 1743)
Chemical apparatus and process disinfecting, deodorizing, preser
Analyzer, structured indicator, or manipulative laboratory...
Sample mechanical transport means in or for automated...
C422S062000, C422S064000, C422S068100, C422S071000, C422S081000, C422S105000, C422S105000, C422S105000, C436S180000, C424S001850, C600S001000, C600S002000, C600S003000, C600S007000, C600S008000
Reexamination Certificate
active
06572823
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to an apparatus and a method for handling a solution and, in particular, to an apparatus and a method for reconstituting a radioactive solution while ensuring minimal radiation exposure to personnel.
BACKGROUND OF THE INVENTION
New radiopharmaceuticals being developed for diagnostic (e.g., Verluma®) and therapeutic (e.g.,
166
Ho-DOTMP and
131
I) purposes often require intricate reconstituting steps before the final drug product is shipped to the end user. For example, to prepare the radiopharmaceutical
166
Ho-DOTMP, a
166
Ho-chloride solution must be quantitatively mixed with the ligand to form the radiopharmaceutical, the pH of the radiopharmaceutical should be tested and adjusted, and the radiopharmaceutical should be sterile filtered into a final dosage vial. Due to the radioactivity associated with the radiopharmaceutical, extreme caution must be used during the mixing and formulation process to minimize the risk of contamination.
The precautions taken to insure the safety of personnel typically involve the use of extensive facilities for handling the reagents and the radiopharmaceutical. The high cost of such facilities has traditionally precluded smaller nuclear medicine clinics and radiopharmacies from being able to reconstitute the radiopharmaceutical at the point of use. Instead, the radiopharmaceutical is reconstituted off-site and transported to the clinic or radiopharmacy where it is to be used. The need to transport the reconstituted radiopharmaceutical introduces an additional safety risk. Further, the delay between the time that the radiopharmaceutical is reconstituted and the time that the radiopharmaceutical is actually used can result in uncertainty with respect to the final dose delivered to the patient receiving the radiopharmaceutical.
In light of the foregoing, it would be highly beneficial to provide an apparatus and a method for reconstituting a radiopharmaceutical wherein the radiopharmaceutical can be reconstituted at the point of use. The apparatus and method should also enable personnel to remotely handle the reagents and the radiopharmaceutical during the mixing and formulation stages of the reconstitution process while shielding the personnel from contamination. Further, the apparatus should be compact so as to be usable as a bench-top model and inexpensive so as to be affordable by clinics and radiopharmacies.
SUMMARY OF THE INVENTION
In accordance with the present invention, an apparatus and a method for handling a solution are provided. The apparatus and method can be used to reconstitute a radiopharmaceutical at the point of use. The apparatus and method also enable personnel to remotely handle the reagents and the radiopharmaceutical during the mixing and formulation stages of the reconstitution process while shielding the personnel from contamination. Further, the apparatus can be made to be compact so as to be usable as a bench-top model and inexpensive so as to be affordable by clinics and radiopharmacies.
The apparatus comprises a housing defining an enclosure designed to shield personnel from hazards associated with the solution. In one embodiment, the housing comprises a radiation shield for shielding personnel from exposure to radiation emitted by reagents contained within the housing. In an alternate embodiment, the housing comprises a shatter-proof and/or flame retardant shield for shielding personnel from the dangers associated with explosive and/or flammable reagents.
A vial assembly is positioned within the enclosure of the housing for maintaining at least one vial within the enclosure of the housing. In one embodiment, the vial assembly defines a vial containment portion integrally formed within the vial assembly for containing said at least one vial. Alternatively, the vial assembly may comprise a vial holder for holding said at least one vial. The vial assembly may further comprise at least one vial shield for positioning over said at least one vial to further protect personnel from hazards associated with the solution. In addition, the vial assembly may comprise a filter, for connection to said at least one vial, to enable gases to escape from the vial while preventing fluid from leaking out of the vial.
A valve manifold extends within the enclosure of the housing for connection to said at least one vial. A syringe is connected to a syringe valve of the valve manifold for injecting and withdrawing fluid through the valve manifold. In one embodiment, a syringe pump is connected to the syringe to facilitate operation of the syringe.
A sampling syringe may be connected between the valve manifold and the vial assembly. In one embodiment, the sampling syringe enables solution to be withdrawn from the apparatus for quality control testing. Alternatively, or additionally, the sampling syringe may enable solution to be withdrawn from the apparatus for measuring and adjusting the pH of the solution.
A rotation means also extends within the enclosure of the housing. The rotation means is operatively connected to the vial assembly for rotating the vial assembly while the vial assembly is connected to the valve manifold.
In one particular embodiment, the apparatus in accordance with the present invention comprises a housing defining an enclosure designed to shield personnel from hazards associated with the solution. A vial assembly is provided within the enclosure of the housing. The vial assembly comprises a combination vial containment portion for containing a combination vial; one or more ligand vial containment portions for containing one or more ligand vials; and a final vial containment portion for containing a final vial. A valve manifold extends within the enclosure of the housing. The valve manifold comprises a sample valve for connection to a sample vial; a combination valve for connection to the combination vial when the combination vial is positioned within the combination vial containment portion; one or more ligand valves for connection to the one or more ligand vials when the ligand vials are positioned within the ligand vial containment portions; and a final valve for connection to the final vial when the final vial is positioned within the final vial containment portion. Rotation means extends within the enclosure to connect to the vial assembly for rotating the vial assembly.
The method for handling a solution in accordance with the present invention comprises the step of injecting a sample solution through a valve manifold into a ligand vial containing a ligand solution, the ligand vial being contained within a vial assembly, the vial assembly being positioned within an enclosure of a housing. Rotation means are then operated, externally from the housing, to rotate the vial assembly and mix the sample solution with the ligand to form a reconstituted sample solution. The pH of the reconstituted sample solution may be determined and adjusted, if the pH is not within an acceptable range. A quality control sample of the reconstituted solution can be taken and analyzed to insure that the reconstituted solution meets predetermined quality control standards. If the reconstituted solution meets the quality control standards, the reconstituted sample solution is transferred to a final vial.
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patent: 4598049 (1986-07-01), Zelinka et al.
patent: 5346999 (1994-09-01), Cathcart et al.
patent: 5425917 (1995-06-01), Schmid
patent: 5559032 (1996-09-01), Pomeroy et al.
patent: 5695720 (1997-12-01), Wade et al.
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patent: WO-9963547 (1999-12-01), None
Donahue John J.
Haepers Joseph
Bex Kathryn
Bristol-Myers Squibb Pharma Company
Golian Paul D.
Warden Jill
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