Sampling systems and related materials and methods
Inventors
Jones, Mitchell Lawrence • Wahl, Christopher Loren • Philippsen, Aaron Olafur Laurence • Allan, Nicholas David • Drlik, Mark Sasha • McGuinness, Ryan Paul • Singh, Sharat • Magyar, Robert S.
Assignees
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Publication Number
US-10588608-B2
Publication Date
2020-03-17
Expiration Date
Abstract
Sampling systems that include an absorbent material a preservative, such as an analyte preservative, as well as related materials and methods, are disclosed.
Core Innovation
The invention relates to an ingestible device that includes a sampling system for collecting gastrointestinal fluid. The sampling system includes a first absorbent member and a second absorbent member different from the first, and fluid flowing from an exterior of the ingestible device into an interior is configured to enter the first absorbent member and flow from the first absorbent member to the second absorbent member.
The ingestible device further includes at least one preservative in connection with the sampling system and absorbent members. The preservation concepts are aimed at stabilizing biomarkers and analytes during transit, including proteins, cytokines, chemokines, interleukins, nucleic acids, small molecules, fecal biomarkers such as calprotectin, and biomarkers associated with gastrointestinal inflammation and disease.
The preservative set is described to include analyte preservatives and bacteria preservatives, including nuclease inhibitors, RNase and DNase inhibitors, protease inhibitors, acids having a pKa range of 3-7, surfactants such as polysorbate and Tween 80, stabilizers such as trehalose and dextran, parabens such as parahydroxybenzoate and propyl paraben, and bacteriostatic, bactericidal, and fixative agents such as sorbic acid, citric acid, EDTA, and sodium azide to preserve microbiome representativeness.
The document also describes using the device and preservative chemistry to obtain representative microbiome data post gastrointestinal transit and to support downstream analysis, including compatibility with ELISA assays and internal control stability. It further describes protein and microbial stabilization chemistry, internal controls for monitoring degradation, and recovery using absorbent and sponge materials such as polyurethane sponges.
Claims Coverage
The provided material includes one independent claim set with 2 inventive features. The independent claim defines the ingestible device architecture and requires at least one preservative associated with the sampling system.
Two absorbent members for sequential fluid flow in an ingestible device
An ingestible device having a sampling system with a first absorbent member configured to absorb a fluid, a second absorbent member different from the first absorbent member, and fluid entering the first absorbent member and flowing from the first absorbent member to the second absorbent member.
At least one preservative associated with the sampling system
An ingestible device in which the sampling system includes at least one preservative in connection with the first absorbent member and the second absorbent member, for preserving analytes during transit.
The claim coverage centers on an ingestible sampling system with first and second different absorbent members that receive and pass GI fluid sequentially, together with at least one preservative to preserve analytes and related targets during transit.
Stated Advantages
Preservation of protein and microbial biomarkers associated with gastrointestinal inflammation and disease for downstream analysis compatibility is stated in the document.
Representative microbiome data post gastrointestinal transit is described as being obtainable using the preservative-supported sampling approach.
Compatibility with ELISA assays is described as being supported by the preserved biomarker approach.
Stabilization of biomarkers, proteins, nucleic acids, and analytes during GI transit.
Preservation of microbiome representativeness during transit.
Documented Applications
Monitoring and analyzing gastrointestinal inflammation and disease biomarkers, including biomarkers for celiac disease and related autoantibodies.
Obtaining representative microbiome data post gastrointestinal transit, including in the context of small intestinal bacterial overgrowth (SIBO).
Support of downstream protein biomarker analysis using ELISA and internal control workflows.
GI tract sampling using an ingestible device for collecting GI fluid or particles for biomarker and microbiome-related analysis, including contexts such as SIBO and fecal biomarkers such as calprotectin.
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