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Publication Number
US-12298268-B2
Publication Date
2025-05-13
Expiration Date
Abstract
A single-use disposable potentiometric reference sensor includes an insulating base substrate, a reference electrode disposed on the insulating base substrate where the reference electrode is a silver-silver chloride electrode, an internal layer disposed on the reference electrode where the internal layer is an amorphous salt layer that includes an amorphous polysaccharide and a salt having equi-mobility cations and anions, and a semipermeable cover membrane disposed over the internal layer where the semipermeable cover membrane has water vapor and ion permeability.
Core Innovation
A single-use disposable potentiometric reference sensor is provided with a reference electrode and an internal layer positioned within an opening over an insulating base substrate. The internal layer is an amorphous salt layer that includes an amorphous polysaccharide and a salt having equi-mobility cations and anions, and a semipermeable cover membrane is disposed on the internal layer within the opening so that at least a portion of the semipermeable cover membrane physically contacts the internal layer. The semipermeable cover membrane has water vapor permeability and ion permeability.
The internal layer addresses limitations associated with prior art approaches, including washout of a salt reservoir and difficulties related to water vapor and ion transport through a membrane. The sensor uses an amorphous polysaccharide/salt configuration to maintain an internal amorphous structure layer over the reference electrode, and the semipermeable cover membrane enables transfer characterized by water vapor permeability and ion permeability.
In multi-layer form, the invention also includes a multi-layer reagent matrix that forms a potentiometric reference electrode into a reference sensor using an internal layer overlying the potentiometric reference electrode and a semipermeable cover membrane physically contacting the internal layer. The internal layer includes an amorphous salt layer mixture with amorphous properties such that, when over saturated with the salt, the amorphous polysaccharide and the salt do not separate when the internal layer is formed, and the internal layer mixture includes potassium chloride and at least one of pullulan, dextran, and amylose.
Claims Coverage
The partial set includes three independent claims that cover a single-use disposable potentiometric reference sensor, a multi-layer reagent matrix for making a reference electrode into a reference sensor, and a method for forming the single-use disposable electrochemical potentiometric reference sensor. Across these independent claims, the inventive features focus on an internal amorphous salt layer and a semipermeable cover membrane that physically contacts the internal layer within an opening over an insulating base substrate.
Single-use disposable potentiometric reference sensor with amorphous equi-mobility internal salt layer and semipermeable water vapor/ion permeable cover membrane
An insulating base substrate; an insulating layer disposed over the insulating base substrate with an opening terminating over the insulating base substrate; a reference electrode at least partially disposed within the opening; an internal layer disposed on the reference electrode within the opening, the internal layer being an amorphous salt layer including an amorphous polysaccharide and a salt having equi-mobility cations and anions; and a semipermeable cover membrane disposed on the internal layer within the opening so at least a portion of the semipermeable cover membrane physically contacts the internal layer, where the semipermeable cover membrane has water vapor permeability and ion permeability.
Multi-layer reagent matrix with amorphous non-separating polysaccharide/salt internal layer and hydrophobic water vapor/ion permeable cover membrane
An internal layer formed from an amorphous salt layer mixture containing an amorphous polysaccharide and a salt, the internal layer overlaying the potentiometric reference electrode, where the amorphous polysaccharide has amorphous properties such that when over saturated with the salt, the amorphous polysaccharide and the salt do not separate when the internal layer is formed, the internal layer being a mixture of potassium chloride and at least one of pullulan, dextran, and amylose; and a semipermeable cover membrane formed from a cover membrane solution disposed on the internal layer such that at least a portion of the semipermeable cover membrane physically contacts the internal layer, the cover membrane solution containing a hydrophobic polymer, where the hydrophobic polymer is water vapor and ion permeable.
Method of forming a single-use disposable electrochemical potentiometric reference sensor with amorphous internal salt layer and semipermeable hydrophobic cover membrane
Providing a sensor body having an insulating base substrate with at least one conductive path, an insulating and reagent holding layer over the insulating base substrate with at least one reagent holding opening terminating over the insulating base substrate and exposing a portion of the at least one conductive path, and a reference electrode at least partially disposed within the at least one reagent holding opening; disposing an amorphous salt layer mixture containing an amorphous polysaccharide and a salt having equi-mobility cations and anions into the at least one reagent holding opening on the reference electrode, drying the amorphous salt layer mixture forming an internal layer that is an amorphous structure layer; disposing a cover membrane solution containing a hydrophobic polymer onto the internal layer; and drying the cover membrane solution forming a semipermeable cover membrane such that at least a portion of the semipermeable cover membrane physically contacts the internal layer, where the semipermeable cover membrane has water vapor permeability and ion permeability.
Across the independent claims, coverage centers on forming an internal amorphous salt layer of an amorphous polysaccharide plus a salt having equi-mobility cations and anions over a reference electrode, and applying a semipermeable cover membrane with water vapor permeability and ion permeability that physically contacts the internal layer. The independent claims further require the layered arrangement to be disposed within an opening formed in an insulating layer over an insulating base substrate, and they include a multi-layer reagent matrix and a method of forming the sensor by disposing and drying the internal layer mixture and the hydrophobic cover membrane.
Stated Advantages
Improved dry, single-use performance and shelf-life objectives are supported by stability testing showing small millivolt changes and low inter-sensor variation.
Documented Applications
Using a single-use disposable potentiometric reference sensor as a planar electrochemical reference sensor/sensor array with junction potential stability testing versus ionic strength.
Forming a potentiometric reference electrode into a reference sensor using a multi-layer reagent matrix.
Forming a single-use disposable electrochemical potentiometric reference sensor by disposing and drying an amorphous salt layer mixture and forming a semipermeable hydrophobic cover membrane.
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