Device comprising a hydrogel having a glucose-binding protein and a ligand of the glucose-binding protein incorporated therein
Inventors
Müller, Achim • Herbrechtsmeier, Peter • Knuth, Monika • Nikolaus, Katharina
Assignees
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Publication Number
US-10429380-B2
Publication Date
2019-10-01
Expiration Date
Abstract
The present invention relates to measures for determining glucose and for diagnosing diseases based on impaired glucose metabolism. In particular the present invention relates to a device comprising a hydrogel having a glucose-binding protein and a ligand of the glucose-binding protein incorporated therein, wherein the hydrogel comprises a first hydrogel matrix made of alginate and a second hydrogel matrix which forms an interpenetrating network within the first hydrogel matrix. The invention further relates to the use of such a device for determining the glucose content in a sample and to the use of the device for diagnosing impaired glucose metabolism in a test subject.
Core Innovation
The invention relates to a glucose sensor/diagnostic device that detects glucose using a hydrogel containing a glucose-binding protein and a ligand of the glucose-binding protein incorporated therein. Glucose detection is based on a glucose-driven displacement of the ligand from the glucose-binding protein, providing a fluorescence readout consistent with energy-transfer mechanisms using dye-labeled components.
The hydrogel comprises a first hydrogel matrix made of alginate and a second hydrogel matrix that forms an interpenetrating network within the first hydrogel matrix. The second hydrogel matrix is formed simultaneously with or sequentially to the first hydrogel matrix, and the first and second hydrogel matrices cannot be separated unless covalent bonds or ionic bonds are broken.
In the fluorescence readout configuration described, the glucose-binding protein can be labeled with an oxazine dye and the glucose-binding ligand can be labeled with a rhodamine dye. A glucose activity enhancement is reported for enriching alginate-based interpenetrating hydrogels compared with aqueous solution, together with greatly increased usable glucose-binding protein concentrations and mitigation of pegylation-related activity loss when used in hydrogel.
Claims Coverage
The independent claim is directed to a hydrogel-based glucose detection device with a non-separable alginate/interpenetrating-network structure incorporating a glucose-binding protein and a ligand. The independent claim set identified here includes one independent device claim (clm-00001).
Non-separable alginate interpenetrating hydrogel device
A device comprising a hydrogel having a glucose-binding protein and a ligand of the glucose-binding protein incorporated therein, wherein the hydrogel comprises a first hydrogel matrix made of alginate and a second hydrogel matrix forming an interpenetrating network within the first hydrogel matrix, with the first and second hydrogel matrix cannot be separated unless covalent bonds or ionic bonds are broken.
Overall, claim coverage centers on incorporating a glucose-binding protein and its ligand inside an alginate-based interpenetrating hydrogel network that is non-separable without breaking covalent or ionic bonds, with refinements that specify linked dye configurations and matrix/linkage constraints.
Stated Advantages
Improved glucose activity in enriched alginate-based interpenetrating hydrogels versus aqueous solution.
Greatly increased usable glucose-binding protein concentrations.
Mitigated pegylation-related activity loss in hydrogel.
Documented Applications
In vitro determination/diagnosis of impaired glucose metabolism, including diabetes mellitus and metabolic syndrome, using samples/body fluids such as tissue fluid, blood, serum, or plasma.
Ex vivo determination/diagnosis of impaired glucose metabolism, including diabetes mellitus and metabolic syndrome.
In vivo determination/diagnosis of impaired glucose metabolism, including diabetes mellitus and metabolic syndrome, using a diagnostic device.
Therapeutic decision support based on determination/diagnosis of impaired glucose metabolism.
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