Use of porous polymer materials for storage of biological samples

• US 10,306,883 B2
• Filed: 01/09/2014
• Issued: 06/04/2019
• Est. Priority Date: 07/12/2011
• Status: Active Grant

• Current Assignee: University of Tasmania
• Original Assignee: University of Tasmania
• Inventors: Hilder, Emily Frances, Hon, Wei Boon
• Primary Examiner(s): Ariani, Kade
• Application Number:
  US14/151,689
• Publication Number:
  US 20140127669A1
• Time in Patent Office: 1,972 Days
• CPC Class Codes: A01N 1/0231 Chemically defined matrices, e.g. alginate gels, for immobilising, holding or storing cells, tissue or organs for preservation purposes; Chemically altering or fixing cells, tissue or organs, e.g. by cross-linking, for preservation purposes
• CPC Class Codes: A01N 1/0278 Physical preservation processes
• CPC Class Codes: B01J 20/267 Cross-linked polymers
• CPC Class Codes: B01J 20/28033 Membrane, sheet, cloth, pad, lamellar or mat
• CPC Class Codes: B01J 20/28042 Shaped bodies; Monolithic structures
• CPC Class Codes: B01J 20/28054 characterised by their surface properties or porosity
• CPC Class Codes: B01J 20/28078 Pore diameter
• CPC Class Codes: B01J 20/321 consisting of a polymer obtained by reactions involving only carbon to carbon unsaturated bonds
• CPC Class Codes: B01J 20/327 Polymers obtained by reactions involving only carbon to carbon unsaturated bonds
• CPC Class Codes: B01J 20/3272 Polymers obtained by reactions otherwise than involving only carbon to carbon unsaturated bonds
• CPC Class Codes: B01L 2200/0678 Facilitating or initiating evaporation
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0822 Slides
• CPC Class Codes: B01L 3/508 rigid containers not provided for above
• CPC Class Codes: C12M 45/22 Means for packing or storing viable microorganisms casings for storing cell samples A61B10/0096, preservation of living parts of the human or animal body A01N1/02

Abstract

The present invention generally relates to the use of porous polymer materials as a medium for the storage of biological samples. The present invention also relates to a method of drying and storage of biological samples on the porous polymer materials. The biological samples include blood and blood plasma samples.

Claims

1. A method of storing a whole blood sample for future analysis comprising applying the whole blood sample directly to a porous polymer monolith material medium and drying the whole blood sample such that the whole blood sample at least partially solidifies and adsorbs or adheres to the porous polymer monolith material;

wherein the porous polymer monolith material medium is formed by a step-growth polymerization process, wherein the medium additionally comprises one or more supporting layers comprising a porous polymer matrix material, wherein the porous polymer matrix material of each of the one or more support layers is selected from a polyether, polyester, polycarbonate, polyanhydride, polythiophene polymer, and an epoxy resin, wherein the medium allows storage of the whole blood sample for at least one day, wherein the whole blood sample is applied directly to the medium, with the proviso that the porous polymer monolith material is polymerized onto or sits on the one or more supporting layers comprising the porous polymer matrix material without one or more intervening layers of functionality formed by photoinitiated grafting.

5. The method of claim 1 wherein the porous polymer monolith material medium has an integral body with a pore size and a specific surface area adapted to facilitate the drying and storage of the biological fluid sample, wherein the pore size of the porous polymer monolith material is in the range of 5 to 10,000 nm and the specific surface area of the porous polymer monolith material when measured by nitrogen adsorption using BET isotherm is in the range of 0.5 to 1000 m²/g.

9. The method of claim 1 wherein the porous polymer monolith material is incorporated with chemical functionality selected from the group consisting of hydrophilic groups and groups with ion exchange properties to facilitate pre-analysis of analytes in the whole blood sample or in situ elimination of undesirable components in the whole blood sample on the medium.

13. The method of claim 1 wherein the step-growth polymerization process for the porous polymer monolith material comprises the polymerization of one or more monomers having one or more functional groups selected from:

hydroxyl, carboxylic acid, anhydride, acyl halide, alkyl halide, acid anhydride, acrylate, methacrylate, aldehyde, amide, amine, guanidine, malimide, thiol, sulfonate, sulfonic acid, sulfonyl ester, carbodiimide, ester, cyano, epoxide, proline, disulfide, imidazole, imide, imine, isocyanate, isothiocyanate, nitro, azide, and combinations thereof.

17. The method of claim 13, wherein the acrylic acid monomer is a methacrylate monomer.

21. The method of claim 17 wherein the methacrylate monomer is selected from hydroxyethyl methacrylate (HEMA) and ethylene glycol dimethacrylate (EDMA).

2. A method of storing a whole blood sample for future analysis comprising:

applying one or more whole blood samples directly to one or more regions of a porous polymer monolith material medium;

partially drying the one or more whole blood samples applied to the medium such that the whole blood sample adsorbs or adheres to the porous polymer monolith material;

optionally separating any one or more regions of the medium having the one or more whole blood sample applied thereto from regions without the one or more whole blood sample applied thereto; and

optionally further drying the one or more whole blood samples applied to the one or more regions of the medium;

wherein the porous polymer monolith material medium is formed by a step-growth polymerization process, wherein the medium additionally comprises one or more supporting layers comprising a porous polymer matrix material, wherein the porous polymer matrix material of each of the one or more support layers is selected from a polyether, polyester, polycarbonate, polyanhydride, polythiophene polymer, and an epoxy resin, wherein the medium allows storage of the whole blood sample for at least one day, wherein the whole blood sample is applied directly to the medium, with the proviso that the porous polymer monolith material is polymerized onto or sits on the one or more supporting layers comprising the porous polymer matrix material without one or more intervening layers of functionality formed by photoinitiated grafting.

6. The method of claim 2 wherein the porous polymer monolith material medium has an integral body with a pore size and a specific surface area adapted to facilitate the drying and storage of the biological fluid sample, wherein the pore size of the porous polymer monolith material is in the range of 5 to 10,000 nm and the specific surface area of the porous polymer monolith material when measured by nitrogen adsorption using BET isotherm is in the range of 0.5 to 1000 m²/g.

10. The method of claim 2 wherein the porous polymer monolith material is incorporated with chemical functionality selected from the group consisting of hydrophilic groups and groups with ion exchange properties to facilitate pre-analysis of analytes in the whole blood sample or in situ elimination of undesirable components in the whole blood sample on the medium.

14. The method of claim 2 wherein the step-growth polymerization process for the porous polymer monolith material comprises the polymerization of one or more monomers having one or more functional groups selected from:

hydroxyl, carboxylic acid, anhydride, acyl halide, alkyl halide, acid anhydride, acrylate, methacrylate, aldehyde, amide, amine, guanidine, malimide, thiol, sulfonate, sulfonic acid, sulfonyl ester, carbodiimide, ester, cyano, epoxide, proline, disulfide, imidazole, imide, imine, isocyanate, isothiocyanate, nitro, azide, and combinations thereof.

18. The method of claim 14, wherein the acrylic acid monomer is a methacrylate monomer.

22. The method of claim 18 wherein the methacrylate monomer is selected from hydroxyethyl methacrylate (HEMA) and ethylene glycol dimethacrylate (EDMA).

3. A method of analysis of a whole blood sample comprising detecting and identifying an analyte from the whole blood sample, wherein the whole blood sample was directly applied to a porous polymer monolith material medium such that the whole blood sample adsorbs or adheres to the porous polymer monolith material and stored for at least one day prior to detecting and identifying the analyte;

wherein the porous polymer monolith material medium is formed by a step-growth polymerization process, wherein the medium additionally comprises one or more supporting layers comprising a porous polymer matrix material, wherein the porous polymer matrix material of each of the one or more support layers is selected from a polyether, polyester, polycarbonate, polyanhydride, polythiophene polymer, and an epoxy resin, wherein the medium allows storage of the whole blood sample for at least one day, wherein the whole blood sample is applied directly to the medium, with the proviso that the porous polymer monolith material is polymerized onto or sits on the one or more supporting layers comprising the porous polymer matrix material without one or more intervening layers of functionality formed by photoinitiated grafting.

7. The method of claim 3 wherein the porous polymer monolith material medium has an integral body with a pore size and a specific surface area adapted to facilitate the drying and storage of the biological fluid sample, wherein the pore size of the porous polymer monolith material is in the range of 5 to 10,000 nm and the specific surface area of the porous polymer monolith material when measured by nitrogen adsorption using BET isotherm is in the range of 0.5 to 1000 m²/g.

11. The method of claim 3 wherein the porous polymer monolith material is incorporated with chemical functionality selected from the group consisting of hydrophilic groups and groups with ion exchange properties to facilitate pre-analysis of analytes in the whole blood sample or in situ elimination of undesirable components in the whole blood sample on the medium.

15. The method of claim 3 wherein the step-growth polymerization process for the porous polymer monolith material comprises the polymerization of one or more monomers having one or more functional groups selected from:

hydroxyl, carboxylic acid, anhydride, acyl halide, alkyl halide, acid anhydride, acrylate, methacrylate, aldehyde, amide, amine, guanidine, malimide, thiol, sulfonate, sulfonic acid, sulfonyl ester, carbodiimide, ester, cyano, epoxide, proline, disulfide, imidazole, imide, imine, isocyanate, isothiocyanate, nitro, azide, and combinations thereof.

19. The method of claim 15, wherein the acrylic acid monomer is a methacrylate monomer.

23. The method of claim 19 wherein the methacrylate monomer is selected from hydroxyethyl methacrylate (HEMA) and ethylene glycol dimethacrylate (EDMA).

4. A method for storing and subsequent analysis of a whole blood sample comprising one or more analytes selected from pharmaceutical agents, peptides, proteins, oligonucleotides, DNA, RNA, oligosaccharides and lipids, the method comprising:

applying the whole blood sample comprising the one or more analytes directly to a porous polymer monolith material medium, wherein the porous polymer monolith material medium is formed by a step-growth polymerization process, wherein the medium additionally comprises one or more supporting layers comprising a porous polymer matrix material, wherein the porous polymer matrix material of each of the one or more support layers is selected from a polyether, polyester, polycarbonate, polyanhydride, polythiophene polymer, and an epoxy resin, wherein the medium allows storage of the whole blood sample for at least one day, wherein the whole blood sample is applied directly to the medium, with the proviso that the porous polymer monolith material is polymerized onto or sits on the one or more supporting layers comprising the porous polymer matrix material without one or more intervening layers of functionality formed by photoinitiated grafting;

drying the whole blood sample applied to the medium such that the whole blood sample adsorbs or adheres to the porous polymer monolith material;

storing the whole blood sample in the medium for at least one day;

retrieving and optionally pre-treating the stored whole blood sample;

and

analyzing the retrieved and optionally pre-treated whole blood sample for the presence of one or more analytes.

8. The method of claim 4 wherein the porous polymer monolith material medium has an integral body with a pore size and a specific surface area adapted to facilitate the drying and storage of the biological fluid sample, wherein the pore size of the porous polymer monolith material is in the range of 5 to 10,000 nm and the specific surface area of the porous polymer monolith material when measured by nitrogen adsorption using BET isotherm is in the range of 0.5 to 1000 m²/g.

12. The method of claim 4 wherein the porous polymer monolith material is incorporated with chemical functionality selected from the group consisting of hydrophilic groups and groups with ion exchange properties to facilitate pre-analysis of analytes in the whole blood sample or in situ elimination of undesirable components in the whole blood sample on the medium.

16. The method of claim 4 wherein the step-growth polymerization process for the porous polymer monolith material comprises the polymerization of one or more monomers having one or more functional groups selected from:

hydroxyl, carboxylic acid, anhydride, acyl halide, alkyl halide, acid anhydride, acrylate, methacrylate, aldehyde, amide, amine, guanidine, malimide, thiol, sulfonate, sulfonic acid, sulfonyl ester, carbodiimide, ester, cyano, epoxide, proline, disulfide, imidazole, imide, imine, isocyanate, isothiocyanate, nitro, azide, and combinations thereof.

20. The method of claim 16, wherein the acrylic acid monomer is a methacrylate monomer.

24. The method of claim 20 wherein the methacrylate monomer is selected from hydroxyethyl methacrylate (HEMA) and ethylene glycol dimethacrylate (EDMA).