Detecting microbial infections in wounds

Inventors

Burnet, Michael • Bowler, Philip • Wroe, Sarah • STEVEN, Jade • METCALF, Daniel • Parsons, David • Ballamy, Lucy • HEINZLE, Andrea • Sigi, Eva • Luschnig, Daniel • GAMERITH, Clemens

Assignees

Qualizyme Diagnostics GmbH and Co KG • Synovo GmbH • Convatec Technologies Inc

Abstract

Provided herein are microbial infection indicator devices, including dressing with indicators, standalone indicator inserts or disks that can be freely placed at a wound site or dressing, and applications thereof for displaying a visible or detectable signal to a user upon detection of an analyte or biomarker indicative of an infection, such as a color change.

Core Innovation

The invention is a wound dressing for early detection of microbial infection using wound exudate–driven enzyme and pH biomarkers. The dressing includes a wound contacting layer, a reagent layer comprising one or more testing regions in fluid communication with the wound contacting layer, and an outer layer overlaying the reagent layer. The testing regions are configured to generate a detectable signal from biomarkers present in wound exudate.

A key structural feature is that the one or more testing regions include a leach-back trap in fluid communication with a reagent pad. One or more lines of wicking stitching or wicking tufting cross through the one or more testing regions only at the leach-back trap, providing localized crossing at the trap. This configuration defines the fluid-handling relationship between the reagent pad and the testing regions.

The disclosed testing regions also include indicator chemistries for microbial-associated signals. The document describes enzyme-reactive protein-indicator conjugates with an enzyme-reactive region attached via an anchor region characterized by Formula (I), together with indicator regions converted into colored species by accessory enzymes and pH indicators.

In addition to the wound dressing architecture, the document describes modular standalone formats and kits for diagnostic use. These formats include indicator inserts/disks and multichannel radial or linear testing regions, as well as dipstick and lateral flow format concepts, and kits that include sampling with a diluent chamber and reaction wells.

Claims Coverage

The provided claim set includes one independent claim defining the core wound dressing architecture and testing-region fluid handling, with dependent claims that further specify testing-region component configurations, fluid communication pathways, indicator chemistry classes, and structural linkage such as alignment of perforations with a leach-back trap. Across the claims, the inventive features concentrate on the leach-back trap and localized wicking crossing, specific testing-region component configurations and fluid communication, and enzyme/pH-based indicator chemistries configured to generate detectable colored species signals.

Across the claims, the inventive coverage centers on a layered wound-dressing architecture that uses a leach-back trap fluidly connected to a reagent pad and restricts wicking stitching/tufting crossing to the leach-back trap. Dependent features further constrain testing-region component configurations and fluid communication pathways and specify enzyme- and pH-based indicator chemistries for colored signal generation, including protein indicator conjugates using Formula (I) and indicator regions cleaved by a target enzyme and converted to colored species using specified accessory enzymes. Additional dependents require structural linkage such as alignment of perforations with the leach-back trap.

Stated Advantages

Documented Applications