Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Means for analyzing liquid or solid sample
Reexamination Certificate
2000-12-04
2004-08-10
Snay, Jeffrey R. (Department: 1743)
Chemical apparatus and process disinfecting, deodorizing, preser
Analyzer, structured indicator, or manipulative laboratory...
Means for analyzing liquid or solid sample
C422S105000
Reexamination Certificate
active
06773673
ABSTRACT:
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH
Not Applicable.
BACKGROUND OF THE INVENTION
The present invention relates to the preparation and use of radioactive isotopes for biological purposes such as labeling, marking, imaging and diagnostics. Such applications generally utilize a single element containing minor amounts of an unstable isotope, which must be generally formed into a simple compound that is incorporated into a solution or reagent which undergoes a known or predictable interaction with the biological system being studied. Thus, for example, radionuclides are often added as labels to a substance that binds to a nucleic acid to indicate the presence of a particular substrate, termination or functional group. Similarly, materials which are taken up by particular biological systems may be labeled for treatment or imaging purposes. Aerosols or radio-labeled fluids may also be used for blood flow or lung function diagnostic imaging studies.
In general, it is necessary that radioactive materials be handled in such a way as to not expose the operator to radiation. Thus they are preferably handled under robotic control or automated conditions. It is desirable that the radioisotopes involved have a short half life, so as to automatically limit the exposure of the subject to radiation, and to facilitate proper disposal. However, materials with a short half life cannot be compounded in advance or stored for lengthy times. Such radionuclides must therefore be manufactured at or near to the site of intended use. In these cases the purification and preparation of the radionuclide in a suitable delivery system must also be accomplished locally. The brevity of the nuclide half life may further complicate its handling and processing. These factors have sometimes prevented the acceptance or use of otherwise worthwhile radionuclide-based procedures.
It would therefore be desirable to provide a convenient system for preparing radionuclides for biological use.
It would also be desirable to provide such a system for handling a radionuclide in an automated fashion without exposing the operator to radiation.
It would further be desirable to provide such a system useful for short-lived materials or small batches to enable the routine use of such materials in individual procedures.
SUMMARY OF THE INVENTION
These and other desirable features are achieved in a system in accordance with the present invention by providing a radioactive marker material such as an unstable isotopic gas to a receiving chamber directly from a source to undergo initial cleansing or concentration, and passing the material into a fluid handling set for automated preparation of the reagent or actual delivery system. In an exemplary embodiment, trace amounts of
13
N, created by proton bombardment of a target at a cyclotron, pass to a receiving chamber, are cleansed and pass into a small bubble of carrier gas. The carrier gas is then delivered into a fluid handling set. The fluid handling set includes or connects to a pressure syringe and a passive syringe, and further includes a plurality, of flushable valves interconnected by tubing in a closed unit to form a flow network in which the pressure syringe may back-flush the tubing, mix the isotope in a delivery liquid, and transfer the mixed liquid to an output for diagnostic imaging or other use. The fluid handling set, which is a closed and preferably sterile unit, may include the receiving chamber
1
, and it mounts in a fixed console of operating motors and condition sensors to control the various steps of fluid handling and delivery, and to effect safety functions which enable the system to connect directly to a catheter or to a vascular injection system for use on human beings.
In a preferred embodiment, the receiving chamber
1
is substantially rigid, but has a region of limited or unidirectional compliance. The chamber receives a flow of trace isotope in a bulk gas, operating to remove the bulk gas while the radionuclide accumulates in a bubble at the outlet port of the chamber. Compliance of the receiving chamber may be effected by means of an elastic wall tensioned against a rigid support such that the wall flexes outwardly under pressure to accommodate the inflow of carrier gas but may not bow inwardly. This maintains the chamber volume above a fixed minimum, and prevents liquid from leaving the chamber when suction is applied at the top. In an illustrative system, nitrogen-13 is generated by cyclotron bombardment of a target with accelerated particles, and when the target has attained a sufficient level of radioactivity, the sample is passed to the receiving chamber and the CO
2
with trace
13
NN is bubbled into a sodium hydroxide solution. The one-way compliant wall allows a large flow to be received and maintained under pressure to accommodate the different rates of carrier delivery and carrier removal effected at this stage. The CO
2
reacts with and is effectively taken up by the sodium hydroxide solution, while the desired nuclide concentrates at a gas-filled plenum at the top of the receiving chamber, where it is accessed at the outlet port using a closed sterile set to effect transfer, mixing and delivery in a form useful for medical imaging. The fluid handling set includes a plurality of three way valves or medical infusion stopcocks that are preconnected together via small bore tubing to form a flow path. Two of the stopcocks each have a third port, which are attached to syringe bodies. One operates as an active bidirectional pump, while various motors and sensors in the console operate and control the position of the stopcock handles to achieve transfer, mixing and delivery of the radionuclide.
REFERENCES:
patent: 5168901 (1992-12-01), Marks
patent: 5223434 (1993-06-01), Kanno et al.
patent: 5326532 (1994-07-01), Taylor
patent: 5468355 (1995-11-01), Shefer et al.
patent: 5482865 (1996-01-01), Ferrieri et al.
patent: 5514071 (1996-05-01), Sielaff, Jr. et al.
patent: 05249244 (1993-09-01), None
J. C. Clark et al., “Short-lived Radioactive Gases for Clinical Use” (Butterworths London and Boston) (1975) Chapter 6 (Nitrogen-13)Exerps.
Layfield Dominick
Venegas José
Nutter & McClennen & Fish LLP
Snay Jeffrey R.
The General Hospital Corporation
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