Integrated Meter for Analyzing Biological Samples
First Claim
Patent Images
1. An analyte monitoring apparatus, comprising:
- a housing;
a user interface coupled with the housing including one or more switches or a display or both;
one or more analyte testing striplets contained in the housing that include both a lancet and an analyte test sensor;
a lancing and testing port defined in the housing for permitting the striplet to contact a lancing site outside the housing;
a set of mechanical components for loading a striplet for a lancing and testing process, for advancing the striplet for lancing through said port at a lancing site proximate to the port, for re-orienting the striplet, and for advancing the striplet for testing at said lancing site also through said port; and
an analyzer for determining a analyte level of a body fluid applied to the test sensor from the lancing site.
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Accused Products
Abstract
Analyte monitoring devices and methods therefore are provided. The devices integrate various functions of analyte monitoring, e.g., sample acquisition and testing.
365 Citations
115 Claims
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1. An analyte monitoring apparatus, comprising:
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a housing; a user interface coupled with the housing including one or more switches or a display or both; one or more analyte testing striplets contained in the housing that include both a lancet and an analyte test sensor; a lancing and testing port defined in the housing for permitting the striplet to contact a lancing site outside the housing; a set of mechanical components for loading a striplet for a lancing and testing process, for advancing the striplet for lancing through said port at a lancing site proximate to the port, for re-orienting the striplet, and for advancing the striplet for testing at said lancing site also through said port; and an analyzer for determining a analyte level of a body fluid applied to the test sensor from the lancing site. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
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27. A analyte monitoring apparatus, comprising:
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a housing; a user interface coupled with the housing including one or more switches or a display or both; multiple analyte testing striplets that include both a lancet and a analyte test sensor; a cartridge coupled within a cartridge compartment within the housing and containing the multiple striplets, wherein the cartridge comprises at least one guide rail for relative positioning within the housing; a seal which generally maintains the striplets within the cartridge free from exposure to ambient air, and is configured for releasing the seal temporarily to permit loading of a striplet for a lancing and testing process. one or more lancing and testing ports defined in the housing for permitting the striplet to contact a lancing site outside the housing; a set of mechanical components for loading a striplet for a lancing and testing process, for advancing the striplet for lancing at a lancing site, and for advancing the striplet for testing at said lancing site, via said one or more lancing and testing ports; and an analyzer for determining a analyte level of a body fluid applied to the test sensor from the lancing site. - View Dependent Claims (28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38)
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39. A analyte monitoring apparatus, comprising:
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a housing; a user interface coupled with the housing including one or more switches or a display or both; multiple analyte testing striplets that include both a lancet and a analyte test sensor; a cartridge which contains the multiple striplets for loading into the housing within a cartridge compartment, one or more inserts within the cartridge for structural support of the striplets within the cartridge, and for desiccating an interior of the cartridge to keep the striplets substantially free of moisture. one or more lancing and testing ports defined in the housing for permitting the striplet to contact a lancing site outside the housing; a set of mechanical components for loading a striplet for a lancing and testing process, for advancing the striplet for lancing at a lancing site, and for advancing the striplet for testing at said lancing site, via said one or more lancing and testing ports; and an analyzer for determining a analyte level of a body fluid applied to the test sensor from the lancing site. - View Dependent Claims (40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50)
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51. A analyte monitoring apparatus, comprising:
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(a) a housing; (b) a user interface coupled with the housing including one or more switches or a display or both; (c) one or more analyte testing striplets that include both a lancet and a analyte test sensor; (d) one or more lancing and testing ports defined in the housing for permitting the striplet to contact a lancing site outside the housing; (e) a set of mechanical components for loading a striplet for a lancing and testing process, for advancing the striplet for lancing at a lancing site, and for advancing the striplet for testing at said lancing site, via said one or more lancing and testing ports; and (f) an analyzer for determining a analyte level of a body fluid applied to the test sensor from the lancing site, and (g) wherein the set of mechanical components comprises; (i) a first mechanical subset including a first set of gears, a pusher, a tub sealing with a striplet compartment, and a turret including a striplet slot within which the striplet is disposed during lancing and testing, for unsealing a striplet compartment for accessing the striplet, advancing the striplet to the turret, and ejecting the striplet after testing; and (ii) a second mechanical subset including a second set of gears, a blade and mating lancet cap contour, the turret, and a carriage which contains the turret, for arming/disarming the lancet by removing/replacing the lancet cap from/to over the lancet, re-orienting the striplet between lancing and testing, and performing both lancing and testing through the lancing and testing port at the lancing site. - View Dependent Claims (52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63)
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64. An assembly for storing and dispensing a plurality of test strips, each test strip comprising a lancet-containing portion and a sensor-containing portion, said assembly comprising
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(b) a platform for containing a biasing element; (c) a place for securing the biasing element; (d) a test strip track for providing a guide path for an assembly for forming an opening in the skin of a patient and collecting a sample of biological liquid emerging from the skin of the patient; (e) a biasing member for urging the test strips toward the test strip track; and (f) an element for advancing a test strip from the assembly to the assembly for forming an opening in the skin of a patient and collecting a sample of biological liquid emerging from the skin of the patient. - View Dependent Claims (65, 66, 67, 68)
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69. An analyte monitoring apparatus, comprising:
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a housing; a user interface coupled with the housing including one or more switches or a display or both; one or more analyte test strips; a testing port defined in the housing for permitting the strip to contact a testing site outside the housing; an ejection port separate from the testing port for disposing of the strip after testing; a set of mechanical components for loading a strip for a testing process, for advancing the strip for testing through said testing port at the testing site proximate to the port, for re-orienting the strip after testing, and for ejecting the strip through the ejection port; and an analyzer for determining an analyte level of a body fluid applied to the test strip from the lancing site. - View Dependent Claims (70, 71, 72, 73, 74, 75)
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76. An analyte monitoring apparatus, comprising:
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a housing; one or more lancets; a lancing port defined in the housing for permitting a lancet to contact a lancing site outside the housing; a separate ejection port for disposing of the lancet after testing; a set of mechanical components for loading a lancet for a lancing process, for advancing the lancet for lancing through said lancing port at the lancing site proximate to the port, for re-orienting the lancet after lancing, and for ejecting the lancet through the ejection port. - View Dependent Claims (77, 78, 79, 80, 81)
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82. A method of providing a sample of body fluid to a test strip for measuring an analyte level within the fluid, comprising:
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(a) providing an integrated analyte testing striplet including a lancet and a test strip that are coupled at different ends of a lancet body of the striplet; (b) loading the testing striplet within a turret of a striplet-containing analyte meter including arming the lancet; (c) piercing a lancing site with the lancet at a predetermined location relative to the meter; and (d) automatically reorienting the striplet within the analyte meter; and (e) automatically advancing and contacting a sample receiving portion of the test strip at the lancing site, such that body fluid from the lancing site is automatically applied to the sample receiving portion of the test strip for measuring an analyte level. - View Dependent Claims (83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99)
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100. An analyte monitoring apparatus, the apparatus comprising:
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(a) a housing for receiving at least one analyte sensor, each analyte sensor comprising a skin piercing member; (b) an electronic circuit for analyzing an analyte parameter from a sample applied to a sensor; and (c) a mechanical assembly in the housing to position a sensor received within the housing to a lancing position and to re-position the lancing-positioned sensor to a testing position. - View Dependent Claims (101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112)
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113. A system for analyte monitoring, the system comprising:
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(a) a meter for determining an analyte concentration from at least one analyte sensor contained therein, each analyte sensor comprising a skin piercing member; (b) at least one analyte sensor contained in the meter, each analyte sensor comprising a skin piercing member; and (c) a mechanical assembly in the meter to move a sensor into a first position for piercing a user'"'"'s skin and into a second position for contacting the sensor to bodily fluid at the pierced site. - View Dependent Claims (114, 115)
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Specification