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AssigneeLifeScan, Inc.
InventorsVadim V. Yuzhakov, Devin V. McAllister, Lorin Olson, Koon-wah Leong, Maria Teodorczyk, Ernest Kiser
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Abstract of Disclosure Devices, systems and methods are provided for piercing the skin, accessing and collecting physiological sample therein, and measuring a characteristic, e.g., an analyte concentration, of the sampled physiological sample. The subject devices are in the form of a test strip which include a biosensor and at least one skin-piercing element which is a planar extension of a portion of the biosensor. At least one fluid pathway resides within a portion of the biosensor and within the skin-piercing element. The skin-piercing element has a space-defining configuration therein which acts as a sample fluid pooling area upon penetration into the skin. Systems are provided which include one or more test strip devices and a meter for making analyte concentration measurements. Methods for using the devices and systems are also provided.
What is claimed is:
The skin-piercing element of claim 1 wherein said opening has a volume in the range from about 50 to 500 nL.
The skin-piercing element of claim 1 wherein said occupies from about 50% to 95% of the volume occupied by said skin-piercing element.
The skin-piercing element of claim 1 wherein said skin-piercing element comprises a plastic material.
The skin-piercing element of claim 1 wherein said fluid pathway is dimensioned to apply a capillary force on fluid present within said pooling area.
The skin-piercing element of claim 1 further comprising a recess within a surface of said skin-piercing element, wherein said recess is in fluid communication with said opening.
The skin-piercing element of claim 6 wherein said recess has a concave configuration.
A test strip device comprising:
The test strip device according to claim 8, wherein said biosensor has an electrochemical configuration.
The test strip device according to claim 9, wherein said biosensor comprises at least two electrodes and wherein said at least one microneedle is a planar extension of one of said at least two electrodes.
The test strip device according to claim 10 wherein said electrode from which said microneedle extends comprises a conductive material formed on a substrate material, and said microneedle is formed from said substrate material.
The test strip device according to claim 11 wherein said microneedle is further formed from said conductive material.
The test strip device according to claim 10 wherein said microneedle and said associated electrode are formed from a unitary structure.
The test strip device according to claim 8 wherein said microneedle comprises a metal material.
The test strip device according to claim 8 wherein said microneedle comprises an inert material.
The test strip device according to claim 10, wherein said biosensor further comprises a spacer layer between said at least two electrodes.
The test strip device according to claim 10 wherein said test strip further comprises a reaction zone between said electrodes and a redox reagent system contained at least within said reaction zone.
The test strip device according to claim 17 wherein said redox reagent system is further contained within at least a portion of said fluid pathway.
The test strip device according to claim 17 wherein a proximal portion of said fluid pathway resides within said reaction zone.
The test strip device according to claim 8, wherein said biosensor has a colorimetric configuration.
The test strip device according to claim 20 wherein said biosensor comprises a substrate having a matrix area defined therein and a membrane covering said matrix area.
The test strip device according to claim 21, wherein said matrix area contains an optical signal producing system.
The test strip device according to claim 21 wherein said membrane comprises a nonporous transparent film.
The test strip device according to claim 8 comprising a plurality of microneedles.
The test strip device according to claim 8 further comprising a plurality of sub-channels extending from and in fluid communication with said fluid pathway.
A system for determining the concentration of at least one analyte in a physiological sample, said system comprising:
The system according to claim 27, further comprising a test strip cartridge for containing a plurality of said test strip devices, said cartridge configured for releasable engagement with said meter.
The system according to claim 28, wherein said cartridge comprises a compartment for holding test strips devices which have been used.
The system according to claim 27, wherein said meter is hand-held.
The system of according to claim 27, wherein said meter comprises a housing, an aperture at a distal end of said housing and a test strip-receiving mechanism within said housing for operatively receiving said at least one test strip device.
The system according to claim 31, wherein said meter further comprises means for spring-loading said test strip device in a retracted position within said distal end of said housing and means for releasing said at least one test strip from said spring-load wherein said at least one test strip is rapidly extended from said aperture.
The system according to claim 31, wherein said distal end of said housing is made of transparent or semi-transparent material.
The system according to claim 31, wherein said meter further comprises a pressure sensor for detecting and measuring pressure against said aperture.
The system according to claim 34, wherein said meter further comprises a pressure sensor indicator for indicating the pressure measured by said pressure sensor.
The system according to claim 27 wherein said meter further comprises a data display.
The system according to claim 27 wherein said meter further comprises a source of negative pressure for applying a vacuum through said fluid pathway for facilitating the transfer of physiological sample exposed to said pathway to within said test strip.
A method for collecting physiological fluid sample from skin, said method comprising:
The method according to claim 38, wherein said step of inserting comprises inserting said at least one skin-piercing element no deeper than the subcutaneous layer of the skin.
The method according to claim 38, wherein said step of inserting comprises inserting said at least one skin-piercing element into the skin for about 1 to 60 seconds.
The method according to claim 38, wherein said step of collecting comprises exerting a capillary force on said pooled physiological fluid.
The method according to claim 38, wherein said at least one skin-piercing element is integral with a biosensor for determining the concentration of at least one analyte in said physiological fluid.
The method according to claim 43, wherein said step of determining the analyte concentration further comprises employing a meter.
The method according to claim 43, wherein said step of determining the analyte concentration is performed by electrochemical means.
The method according to claim 43, wherein said step of determining the analyte concentration is performed by colorimetric means.
The method according to claim 46, wherein said step of determining is performed by fluorescent measuring means.
The method according to claim 38, wherein said physiological fluid is blood and said analyte is glucose.
The method according to claim 38 wherein said pooling area has a volume which is about 50% to 99% of the volume occupied by said skin piercing element.
The method according to claim 49 wherein said pooling area has a volume which is about 50% to 75% of the volume occupied by said skin piercing element.
A method for collecting a sample of physiological fluid, said method comprising the steps of:
The method of claim 51 further comprising the step of extracting said pooled physiological sample to biosensor outside the skin.
The method of claim 51 wherein said pooling area has a volume within the range from about 50 to 250 nL.
A method for determining the concentration of at least one analyte within a physiological fluid sample, said method comprising the steps of:
The method according to claim 54 further comprising the step of applying optimal pressure against said target skin surface with said distal end of said meter.
The method according to claim 55 wherein said step of applying optimal pressure comprises the steps of:
The method according to claim 54 wherein said step of collecting said pooled physiological fluid comprises exerting a capillary force on said pooled physiological fluid by means of said fluid pathway.
The method according to claim 54 wherein said step of collecting further comprises applying pressure about the microneedle piercing site.
The method according to claim 54 wherein said step of collecting further comprises applying a negative pressure to said pooled physiological fluid.
The method according to claim 54 wherein said test strip device is visualized during one or more steps of said method.
The method according to claim 60 wherein said one or more steps include steps (a), (b), (c) or (d).
The method according to claim 54 wherein said step of providing comprises the step of inserting said test strip into said distal end of said meter.
The method according to claim 54 wherein said step of inserting comprises inserting said test strip through said aperture.
The method according to claim 54 wherein said step of providing comprises removing a distal portion of said meter and inserting said test strip into said receiving means within said distal end of said meter.
A kit for determining at least one target analyte concentration of a physiological sample, said kit comprising a system according to claim 27.
The kit according to claim 65, wherein said meter is disposable.
A kit according to claim 65 further comprising instructions for using said system.
A kit for determining at least one target analyte concentration of a physiological sample, said kit comprising a plurality of test strips according to claim 8.
Dependencies are inferred from the claim text.