Method and system for providing an integrated analyte sensor insertion device and data processing unit
First Claim
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1. An apparatus comprising:
- a disposable assembly including;
a housing;
a data processing unit disposed in the housing;
an introducer removably disposed within the housing and within the data processing unit, the introducer including a first portion having a sharp distal end configured for piercing through a skin layer of a subject, wherein the first portion of the introducer is removable from the housing after piercing through the skin layer of the subject; and
an analyte sensor including a first portion and a second portion, the first portion of the analyte sensor coupled to the first portion of the introducer, and the second portion of the analyte sensor coupled to the data processing unit;
wherein the first portion of the analyte sensor is configured for transcutaneous placement so as to be in fluid contact with an interstitial fluid of the subject;
wherein the second portion of the analyte sensor is in electrical contact with the data processing unit prior to transcutaneous placement of the first portion of the analyte sensor; and
wherein the housing, the data processing unit and the introducer are pre-assembled to form the disposable assembly, and the housing includes a self-sealing aperture through which the introducer is removable.
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Abstract
Method and apparatus for providing an integrated analyte sensor and data processing unit assembly is provided.
851 Citations
35 Claims
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1. An apparatus comprising:
a disposable assembly including; a housing; a data processing unit disposed in the housing; an introducer removably disposed within the housing and within the data processing unit, the introducer including a first portion having a sharp distal end configured for piercing through a skin layer of a subject, wherein the first portion of the introducer is removable from the housing after piercing through the skin layer of the subject; and an analyte sensor including a first portion and a second portion, the first portion of the analyte sensor coupled to the first portion of the introducer, and the second portion of the analyte sensor coupled to the data processing unit; wherein the first portion of the analyte sensor is configured for transcutaneous placement so as to be in fluid contact with an interstitial fluid of the subject; wherein the second portion of the analyte sensor is in electrical contact with the data processing unit prior to transcutaneous placement of the first portion of the analyte sensor; and wherein the housing, the data processing unit and the introducer are pre-assembled to form the disposable assembly, and the housing includes a self-sealing aperture through which the introducer is removable. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. An integrated assembly, comprising:
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a housing; a data processing unit disposed within the housing; an introducer having at least a portion removably disposed within the housing and within the data processing unit, the introducer including a first portion having a sharp distal end configured for piercing through a skin layer of a subject, wherein the first portion of the introducer is removable from the housing after piercing through the skin layer of the subject; and an analyte sensor coupled to the housing, a first portion of the analyte sensor configured for subcutaneous placement and so as to be in fluid contact with an interstitial fluid of the subject, and a second portion of the analyte sensor disposed within the housing and in electrical communication with the data processing unit prior to subcutaneous placement of the first portion of the analyte sensor; wherein the housing, the data processing unit, the introducer, and the analyte sensor are pre-assembled as a single disposable unit, and the housing includes a self-sealing aperture through which the introducer is removable. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27)
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28. A method of monitoring an analyte within the interstitial fluid under the skin of a subject, the method comprising:
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providing a pre-assembled integrated assembly comprising a housing and a data processing unit disposed within the housing, an introducer removably disposed at least partially within the housing and the data processing unit, and an analyte sensor disposed at least partially within a first portion of the introducer, the first portion of the introducer having a sharp distal end configured for piercing through the skin of the subject, wherein the housing includes a self-sealing aperture through which the introducer is removable; positioning the integrated assembly at a target location on the skin of the subject; using the first portion of introducer to transcutaneously position a portion of the sensor under the skin; and removing the first portion of introducer from the integrated assembly while the integrated assembly is maintained at the target location and the sensor is retained under the skin. - View Dependent Claims (29, 30, 31, 32, 33, 34, 35)
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Specification