US4094965A
Expired / Lapsed
US
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Diagnostic agents containing albumin and method for making same
Assignee: EIDP Inc
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Filing: 1977-04-01
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Granted: 1978-06-13
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Expires: 1997-04-01
Abstract
Abstract Diagnostic compositions comprising serum albumin which has been treated to remove fats and fatty acids with possible changes in molecular conformation, a reducing agent, preferably a stannous reducing agent, and a radionuclide, preferably technetium-99m, are highly useful in study and diagnosis of morphology and functions of animal tissues and organs, particularly in studying cardiovascular dynamics, placental imaging, cisternography, in determining blood and plasma volumes, in metabolism and turnover studies, in radioscintigraphic diagnosis of the lung and reticuloendothelial systems, e.g. pulmonary emboli, bronchogenic carcinoma, pneumonitis, emphysema, tuberculosis, pathology of liver and/or spleen manifest by changes in size or shape or pathology of adjacent structures or displacement of these organs, and other disorders. For pulmonary and reticuloendothelial applications, the albumin is converted to particulate forms by denaturation under conditions which form aggregates of appropriate size.
Inventors
- 👤 Warren W. Layne
- 👤 Eugene L. Saklad
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 13:42
CPC Classifications
A; A61; A61K; A61K51/00; A61K51/12; A61K51/1217; A61K51/02; A61K51/04; A61K51/08; A61K51/081; A61K51/1241; A61K51/1255; A61K2123/00; Y; Y10; Y10S; Y10S530/00; Y10S530/806; Y10T; Y10T428/00; Y10T428/29; Y10T428/2982; Y10T428/2989
Claims Analysis
Total Claims: 36
Claim 1
Independent Claim
28 words
A material for labeling with a radionuclide (for radioactive testing) comprising the product of admixture of a reducing agent and serum albumin from which lipids have been removed.
Claim 2
Dependent Claim
28 words
A material for labeling with a radionuclide (for radioactive testing) comprising the product of admixture of a reducing agent and serum albumin from which lipids have been removed.
Claim 3
Dependent Claim
20 words
The material of claim 1, wherein the amount of lipids is less than about 2 moles per mole of albumin.
Claim 4
Dependent Claim
21 words
The material of claim 1, wherein the amount of fatty acid is less than about 0.1 mole per mole of albumin.
Claim 5
Dependent Claim
22 words
The material of claim 1, wherein the stannous is present in amounts of about 0.0005% to 10% by weight of the albumin.
Claim 6
Dependent Claim
11 words
The material of claim 1, wherein the albumin is macro-aggregated albumin.
Claim 7
Dependent Claim
11 words
The material of claim 1, wherein the albumin is micro-aggregated albumin.
Claim 8
Independent Claim
40 words
The method of making a material for complexing with a radionuclide for radioactive scanning, comprising removing lipids from serum albumin to produce defatted albumin and mixing the defatted albumin with a source of stannous ions at a pH below 7.
Claim 9
Independent Claim
40 words
The method of making a material for complexing with a radionuclide for radioactive scanning, comprising removing lipids from serum albumin to produce defatted albumin and mixing the defatted albumin with a source of stannous ions at a pH below 7.
Claim 10
Dependent Claim
38 words
The method according to claim 7 wherein the lipids are removed from the normal human serum albumin by contacting the normal human serum albumin with carbon, and separating the carbon and sorbed fatty acids from the defatted albumin.
Claim 11
Dependent Claim
22 words
The method of claim 7 further comprising forming aggregates of defatted albumin having a particle size of about 0.1 to 100 μm.
Claim 12
Dependent Claim
18 words
The method of claim 9 where the particle size of the aggregates are about 15 to 50 μm.
Claim 13
Dependent Claim
55 words
A diagnostic agent for use in radiological testing, comprising the product of admixture of a source of radionuclide ions, a reducing agent, and a defatted albumin, said defatted albumin being sufficiently purified that an aqueous solution of said agent does not become cloudy for at least one hour at a pH of 4 or below.
Claim 14
Dependent Claim
55 words
A diagnostic agent for use in radiological testing, comprising the product of admixture of a source of radionuclide ions, a reducing agent, and a defatted albumin, said defatted albumin being sufficiently purified that an aqueous solution of said agent does not become cloudy for at least one hour at a pH of 4 or below.
Claim 15
Dependent Claim
10 words
The agent of claim 11, wherein the radionuclide is technetium.
Claim 16
Dependent Claim
14 words
The agent of claim 11, wherein the reducing agent is a stannous reducing agent.
Claim 17
Dependent Claim
25 words
The agent of claim 13, wherein the stannous ions are present in an amount of 0.0005% to 0.5% of the weight of the defatted albumin.
Claim 18
Dependent Claim
23 words
The agent of claim 14 wherein the defatted albumin is denatured defatted albumin, having a particle size of about 0.1 to 100 μm.
Claim 19
Dependent Claim
21 words
The agent of claim 15 wherein the denatured defatted albumin is macroaggregated albumin having a particle size of about 15-50 μm.
Claim 20
Independent Claim
38 words
A method of making radioactive diagnostic agent suitable for use in radiological scanning, comprising delipidizing normal human serum albumin, and mixing the delipidized normal human serum albumin with a source of radionuclide and a source of reducing agent.
Claim 21
Independent Claim
38 words
A method of making radioactive diagnostic agent suitable for use in radiological scanning, comprising delipidizing normal human serum albumin, and mixing the delipidized normal human serum albumin with a source of radionuclide and a source of reducing agent.
Claim 22
Dependent Claim
10 words
The method of claim 17, wherein the radionuclide is technetium-99m.
Claim 23
Dependent Claim
11 words
The method of claim 17, wherein the reducing agent is stannous.
Claim 24
Dependent Claim
23 words
A kit for forming a radioactive diagnostic composition comprising a reducing agent and delipidized serum albumin, packaged in a sealed, sterile, non-pyrogenic container.
Claim 25
Dependent Claim
23 words
A kit for forming a radioactive diagnostic composition comprising a reducing agent and delipidized serum albumin, packaged in a sealed, sterile, non-pyrogenic container.
Claim 26
Dependent Claim
22 words
The kit of claim 20 wherein said reducing agent and said delipidized serum albumin are in the form of a freeze-dried solid.
Claim 27
Dependent Claim
11 words
The kit of claim 20 wherein the reducing agent is stannous.
Claim 28
Independent Claim
35 words
A method of concentrating technetium-99m in vivo in a target tissue of a mammal comprising intravenously administering to the mammal a radioactive composition comprising a mixture of technetium-99m, a reducing agent and delipidized serum albumin.
Claim 29
Independent Claim
35 words
A method of concentrating technetium-99m in vivo in a target tissue of a mammal comprising intravenously administering to the mammal a radioactive composition comprising a mixture of technetium-99m, a reducing agent and delipidized serum albumin.
Claim 30
Dependent Claim
28 words
The method of claim 23, wherein said composition contains sufficient technetium-99m to provide radioactivity in the amount of from about 1 to 400μci per kilogram of body weight.
Claim 31
Dependent Claim
14 words
The method of claim 23, wherein the reducing agent comprises a stannous reducing agent.
Claim 32
Independent Claim
26 words
A method of preparing a radioactive diagnostic agent, comprising forming a mixture of a reducing agent and delipidized serum albumin, and combining technetium-99m with said mixture.
Claim 33
Independent Claim
26 words
A method of preparing a radioactive diagnostic agent, comprising forming a mixture of a reducing agent and delipidized serum albumin, and combining technetium-99m with said mixture.
Claim 34
Dependent Claim
16 words
The method of claim 26, wherein said mixture is lyophilized prior to being combined with technetium-99m.
Claim 35
Dependent Claim
11 words
The method of claim 17, wherein the albumin is micro-aggregated albumin.
Claim 36
Dependent Claim
11 words
The method of claim 17 wherein the albumin is macro-aggregated albumin.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1981-06-12 | 1981-12-12 | 1982-06-13 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1985-06-12 | 1985-12-12 | 1986-06-13 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1989-06-12 | 1989-12-12 | 1990-06-13 | $7700.00 | Window Closed / Lapsed |