# US 8,569,713 B2 · Radionuclide generator and method of sterilization

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- Number: US 8,569,713 B2
- Document ID: US8569713B2
- Status: Granted
- Kind: B2
- Application number: 13/320,216
- Filed: 2009-05-13
- Published: 2012-07-26
- Granted: 2013-10-29
- Earliest claimed: 2009-05-13
- Assignees: Lantheus Medical Imaging, Inc.
- Applicants: John Henry Evers
- Inventors: John Henry Evers
- Web page: https://patentgrep.com/patent/US8569713B2

## CPC

- A61L 2/20: Gaseous substances, e.g. vapours
- G21G 1/0005: {Isotope delivery systems (use of radioisotopes as tracers G21H5/02)}
- G21G 4/04: Radioactive sources other than neutron sources (radioactive dressings A61N5/1029)
- G21G 4/06: characterised by constructional features
- Y10T 29/494: Fluidic or fluid actuated device making
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- G21G: CONVERSION OF CHEMICAL ELEMENTS; RADIOACTIVE SOURCES (applications of radiation in general G21H5/00; handling particles, e.g. neutrons, or electromagnetic radiation not otherwise provided for G21K)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A column assembly of a radionuclide generator includes a column that retains a parent radionuclide that spontaneouosly decays to a relatively short-lived daughter radionuclide. A fluid path extends from an inlet port to the column and then to an outlet port and allows daughter radionuclide to be eluted from the radionuclide generator for use. Improved retention of parent radionuclide in the column is accomplished by preventing fluid from entering the flow path in a liquid state, such as during sterilization. Proper column chemistry is also promoted by preventing excess moisture from coalescing in the column, which may promote a higher and/or more reliable yield of daughter radionuclide from a radionuclide generator.

## Claims

### Claim 1

A column assembly of a radionuclide generator, comprising:
a column having an interior containing a medium for retaining a long-lived parent radionuclide that produces a relatively short-lived daughter radionuclide;
an inlet port in fluid communication with the interior of the column; and
an outlet port in fluid communication with the interior of the column;
wherein the column assembly includes a vent opening that provides fluid access to the interior of the column via the outlet port, the vent opening oriented to face downwardly when the column is positioned below the outlet port during sterilization to prevent condensate from entering the vent opening from above.

### Claim 2 (depends on 1)

The column assembly of claim 1, further comprising:
an outlet cover that at least partially covers the outlet port and that at least partially defines the vent opening.

### Claim 3 (depends on 2)

The column assembly of claim 2, wherein the outlet port includes a needle structure and the outlet cover includes a pierceable membrane that receives the needle structure of the outlet port.

### Claim 4 (depends on 2)

The column assembly of claim 2, wherein the outlet cover includes a body portion and a removable cap.

### Claim 5 (depends on 4)

The column assembly of claim 4, wherein the vent opening is defined as an annular space between the removable cap and the body portion.

### Claim 6 (depends on 4)

The column assembly of claim 4, further comprising:
a filter in the outlet cover.

### Claim 7 (depends on 6)

The column assembly of claim 6, wherein the filter is bacteria retentive.

### Claim 8 (depends on 6)

The column assembly of claim 6, wherein the filter is positioned at the vent opening.

### Claim 9 (depends on 1)

The column assembly of claim 1, further comprising:
a filter positioned between and in fluid communication with the outlet port and the column.

### Claim 10 (depends on 1)

The column assembly of claim 1, wherein the inlet port is accessible from outside of a shielded package that receives the column assembly, when the column is inside of the shielded package.

### Claim 11 (depends on 10)

The column assembly of claim 10, in combination with the shielded package.

### Claim 12 (depends on 1)

The column assembly of claim 1, further comprising:
a plug removably attached to the inlet port to block fluid communication to the inlet port from an atmosphere outside of the column assembly.

### Claim 13 (depends on 1)

The column assembly of claim 1, wherein the medium includes alumina.

### Claim 14 (depends on 1)

The column assembly of claim 1, in combination with the long-lived parent radionuclide and the relatively short-lived daughter radionuclide.

### Claim 15 (depends on 14)

The combination of claim 14, wherein the long-lived parent radionuclide includes molybdenum-99 and the relatively short-lived daughter radionuclide includes technetium-99m.

### Claim 16

A method of producing a terminally sterile column assembly of a radionuclide generator, comprising:
providing a column assembly of a radionuclide generator that includes:
a column having a long-lived parent radionuclide that produces a relatively short-lived daughter radionuclide;
an inlet port in fluid communication with the column; and
an outlet port in fluid communication with the column, the outlet port includes a vent opening that provides fluid access to the column;
positioning the column assembly in an orientation with the vent opening facing downwardly to prevent condensate from entering the vent opening from above; and
exposing the column assembly to steam for sterilization.

### Claim 17

A column assembly of a radionuclide generator, comprising:
a column and an outlet port, the column including a medium for retaining a long-lived parent radionuclide that produces a relatively short-lived daughter radionuclide, the outlet port in fluid communication with the column and covered with a vented outlet cover to provide a terminally sterilizable column assembly, the vented outlet cover having a vent opening that provides fluid access to the column and that prevents the ingress of gravity-driven liquid to produce a column assembly that consistently exhibits high yield.

### Claim 18

A column assembly of a radionuclide generator, comprising:
a column and an outlet port, the column including a medium for retaining a long-lived parent radionuclide that produces a relatively short-lived daughter radionuclide, the outlet port in fluid communication with the column and covered with a vented outlet cover to provide a terminally sterilizable column assembly, wherein means are provided to prevent the ingress of gravity-driven liquid to produce a column assembly that consistently exhibits high yield and that prevents migration of parent radionuclide away from the column.

### Claim 19

A column assembly of a radionuclide generator, comprising:
a column and an outlet port, the column including a medium for retaining a long-lived parent radionuclide that produces a relatively short-lived daughter radionuclide, the outlet port in fluid communication with the column and a means that allows for an exchange of steam while reliably preventing excess liquid from being introduced to portions of the column assembly during sterilization.

### Claim 20

A column assembly of a radionuclide generator, comprising:
a column and an outlet port, the column including a medium for retaining a long-lived parent radionuclide that produces a relatively short-lived daughter radionuclide, the outlet port in fluid communication with the column and covered with a vented outlet cover to provide a terminally sterilizable column assembly, the vented outlet cover having a vent opening that provides fluid access to the column and that prevents the ingress of gravity-driven liquid to produce a column assembly that prevents migration of parent radionuclide away from the column.
