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Publication Number
US-10687790-B2
Publication Date
2020-06-23
Expiration Date
Abstract
A medical sampling device, a method of manufacturing the device, and methods of testing and diagnosis using the device; a sampling dressing comprising the device, a method of manufacturing the dressing, and a method of diagnosis using the dressing; and a therapy dressing comprising the device, a method of manufacturing the dressing, and a method of treatment using the dressing. The a sampling device comprises a biodegradable porous scaffold which in use lies in contact with tissue to be sampled and comprises a fluid, in particular a reversibly thermoswitchable gel.
Core Innovation
The invention provides a sampling device for capturing a biological marker. The device comprises a biodegradable porous scaffold configured to lie in contact with tissue to be sampled and a fluid loaded into the scaffold so that a biological marker infiltrates into the fluid. The biodegradable porous scaffold comprises a polymer fibre selected from poly(L-lactic acid) (PLLA), poly(D-lactic acid) (PDLA), poly(D/L-lactic acid) (PDLLA), poly(glycolic acid) (PGA), poly(lactic acid-co-glycolic acid) (PLGA), polycaprolactone (PCL), polydioxanone (PDO), poly(trimethylene carbonate) (PTMC), poly(ethylene glycol) (PEG), and mixtures thereof.
The fluid consists of an aqueous solution of one or more thermo-switchable gel materials, where the thermo-switchable gel materials thermally gel from a liquid below a given temperature or temperature range to a gel above that temperature or temperature range. The gel formation is selected to be reversible. The given temperature or temperature range is at or near normal body temperature for a human or animal patient, or at or near the optimum incubation temperature for tissue grown in vitro on the scaffold.
Each thermo-switchable gel material is a triblock copolymer containing either PLGA random copolymer end blocks and a PEG homopolymer central block, or a PEO random copolymer and a PPO homopolymer central block. The device is described as enabling biological marker capture without centralized testing by supporting a local sampling and assay approach that can be reversed to retrieve information.
Claims Coverage
The document provides one independent claim covering the sampling device architecture and gel-loaded fluid behavior, with dependent claims narrowing scaffold fibre dimensions, gel material chemistry and concentration, fluid penetration, and the categories of biological markers captured. The independent claim contains 3 main inventive aspects: a biodegradable porous scaffold in tissue contact, a fluid loaded into the scaffold using reversible thermo-switchable triblock copolymer gels, and infiltration of a biological marker into the fluid at body/optimal incubation temperature.
Biodegradable porous scaffold in tissue contact
A biodegradable porous scaffold configured to, in use, lie in contact with tissue to be sampled, comprising polymer fibre selected from PLLA, PDLA, PDLLA, PGA, PLGA, PCL, PDO, PTMC, PEG, and mixtures thereof, wherein the polymer fibre has a mean fibre diameter of from about 1.2 to 4.0 microns.
Reversible thermo-switchable aqueous gel fluid loaded into the scaffold
A fluid loaded into the scaffold, wherein the fluid consists of an aqueous solution of one or more thermo-switchable gel materials that thermally gel from a liquid below a given temperature or temperature range to a gel above that temperature or temperature range, wherein gel formation is selected to be reversible.
Triblock copolymer thermo-switching near body or incubation temperature enabling marker infiltration
Each of the one or more thermo-switchable gel materials is a triblock copolymer containing PLGA random copolymer end blocks and a PEG homopolymer central block, or a PEO random copolymer and a PPO homopolymer central block; wherein the given temperature or temperature range is at or near normal body temperature for a human or animal patient, or at or near the optimum incubation temperature for tissue grown in vitro on the scaffold; and wherein the fluid and scaffold allow a biological marker to infiltrate into the fluid.
Overall, claim coverage is directed to a tissue-contact biodegradable porous scaffold loaded with an aqueous reversible thermo-switchable triblock copolymer gel that gels reversibly near body or optimal incubation temperature and supports infiltration of a biological marker into the fluid.
Stated Advantages
Less invasiveness/pain associated with wound sampling.
Avoiding further wound damage.
Earlier intervention based on captured marker information.
Potential tissue regeneration.
Biological marker sampling that supports biological marker capture/assay without centralized testing.
Documented Applications
Wound sampling and use as a therapeutic dressing / wound contact layer configuration for capturing biological markers while in contact with tissue.
Point-of-care testing (POCT) / point-of-use diagnostic assay based on marker capture without centralized testing.
In vitro tissue culture sampling on the scaffold where the given temperature or temperature range is at or near the optimum incubation temperature for tissue grown in vitro on the scaffold.
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