Integrated lancing and analytic device
First Claim
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1. An integrated lancing and analytic device for collecting fluid from skin said device having a lance and an analytic device integrated into a single device body wherein:
- i. the lance has a tapered skin penetrating portion extendible from the body so that it penetrates the skin to release fluid when the body of the device is held to the skin;
ii. the analytic device comprises an inlet, an analytic region having capillary dimensions, an outlet and a signal pathway wherein the analytic region is positioned in fluid communication between the inlet and outlet and the signal pathway transmits a signal of analysis from the analytic region to the outside said signal not visible to a user; and
iii. wherein the lance and inlet of the analytic device are positioned in the device body at an angle of less than 180 degrees so that the fluid released by the lance is taken up into the inlet by having the device body direct the lance and the analytic device to the fluid released from the skin.
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Abstract
This invention provides for an integrated device having a lance and analytic device in a single disposable unit where the lance releases fluid from skin and the analytic device collects and analyzes the fluid without the user removing an instrument housing which holds the disposable unit. In addition to the device, this invention provides for methods of using and manufacturing the device.
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Citations
52 Claims
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1. An integrated lancing and analytic device for collecting fluid from skin said device having a lance and an analytic device integrated into a single device body wherein:
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i. the lance has a tapered skin penetrating portion extendible from the body so that it penetrates the skin to release fluid when the body of the device is held to the skin;
ii. the analytic device comprises an inlet, an analytic region having capillary dimensions, an outlet and a signal pathway wherein the analytic region is positioned in fluid communication between the inlet and outlet and the signal pathway transmits a signal of analysis from the analytic region to the outside said signal not visible to a user; and
iii. wherein the lance and inlet of the analytic device are positioned in the device body at an angle of less than 180 degrees so that the fluid released by the lance is taken up into the inlet by having the device body direct the lance and the analytic device to the fluid released from the skin. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. An instrument system comprising an instrument housing containing an integrated lancing and analytic device for collecting fluid from skin said instrument housing fitted to removably house the device said device having a lance and an analytic device integrated into a single device body wherein:
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i. the lance has a tapered skin penetrating portion which extends from the body so that it penetrates the skin and retracts to release fluid from the skin when the instrument housing is held to the skin;
ii. the analytic device that comprises an inlet, an analytic region, an outlet and a signal pathway wherein the analytic region is of capillary dimension and is positioned in fluid communication between the inlet and outlet and the signal pathway transmits a signal of analysis from the analytic region to the outside said signal not visible to a user; and
iii. wherein the lance and inlet of the analytic device are positioned in the device body at an angle of less than 180 degrees so that the fluid released by the lance is taken up into the inlet without removing the instrument housing from the skin. - View Dependent Claims (17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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33. A method of collecting and analyzing fluids from skin said method comprising the steps of:
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a) positioning on the skin of an animal an instrument housing containing a removable, integrated lancing and analytic device for collecting fluid from skin said device having a lance and an analytic device integrated into a single device body wherein;
i. the lance comprises a tapered skin penetrating portion which extends from the body so that it penetrates and releases fluid from the skin when the body of the device is held to the skin;
ii. the analytic device comprises an inlet, an analytic region, an outlet and a signal pathway wherein the analytic region is of capillary dimension and is positioned in fluid communication between the inlet and outlet and the signal pathway transmits a signal of analysis from the analytic region to the outside where the signal is not visible to the user; and
iii. wherein the lance and inlet of the analytic device are positioned in the device body at an angle of less than 180 degrees so that the fluid released by the lance is taken up into the inlet by directing the lance and the analytic device to the fluid without removing the instrument housing from the skin;
b) penetrating the lance into the skin to release fluid; and
c) positioning the analytic device to the location on the skin penetrated by the lance; and
d) analyzing the fluid that enters the analytic device through the inlet. - View Dependent Claims (34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45)
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46. A process for manufacturing an integrated lancing and analytic device for collecting fluid from skin said device having a lance and an analytic device integrated into a single device body said process comprising attaching a lance and analytic device to a device body wherein the lance and inlet of the analytic device are positioned in the device body so that fluid released by the lance is taken up into the inlet without having to remove the device from the skin, by directing the lance and the analytic device to the same position on the skin,
wherein the lance has a tapered, skin-penetrating portion configured to extend from the body so that it penetrates and releases fluid from the skin when the body of the device is held to the skin; - and,
wherein the analytic device comprises an inlet, an analytic region, an outlet and a signal pathway wherein the analytic region is of capillary dimension and positioned in fluid communication between the inlet and outlet and the signal pathway transmits a signal of analysis from the analytic region to the outside. - View Dependent Claims (47, 48, 49, 50, 51, 52)
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Specification