A minimally intrusive and less painful, self-use microsampling device and method for the measurement of glucose and other analytes in blood are provided. The device of the invention may have one or two optical windows for measuring the concentration of an absorbent reaction product or no windows if methods other than optical absorbance is used. The sampling chamber of the device can contain analytical reagents and other additives to facilitate the sampling and analytical steps. Also provided is a fabrication method for the microsampling device.
A disposable lancet combined with a reagent carrying strip which carries a reagent that indicates the concentration of a blood component in a blood sample placed in contact with the strip. The reagent carrying strip is connected to the lancet, e.g. by molding. One end of the lancet is sharpened for piercing the skin. The strip is sheet-like and has a first side and a second side, which sides are both accessible for the user, such that the reagent carrying strip can be inserted into a blood glucose meter. A weakened tear line is provided at a connection between the lancet and an edge of the reagent carrying strip so that the reagent carrying strip may be easily disconnected from the lancet.
A silicon nitride cuvette window for a microsampling device and method of construction are provided. The sample to be analyzed is drawn into the cuvette of the microsampling device. The silicon nitride window permits optical measurements to be made on analytes contained within the cuvette.
A method of enhancing the permeability of a biological membrane, including the skin or mucosa of an animal or the outer layer of a plant to a permeant is described utilizing microporation of selected depth and optionally one or more of sonic, electromagnetic, mechanical and thermal energy and a chemical enhancer. Microporation is accomplished to form a micropore of selected depth in the biological membrane and the porated site is contacted with the permeant. Additional permeation enhancement measures may be applied to the site to enhance both the flux rate of the permeant into the organism through the micropores as well as into targeted tissues within the organism.
To prevent blood from clotting or being diluted (which causes inaccuracy in the measurement of the characteristics of blood drawn from a patient), a needle assembly has the interior portion of its cannula and at least one portion of its hub covered by a dry coat of anticoagulant. To provide the dry coat of anticoagulant onto the interior surfaces of the cannula and the hub, a liquid anticoagulant is atomized thereto so that an even coat of the anticoagulant is provided to the interior surfaces of the cannula and hub. The volume and concentration of the anticoagulant atomized to the inside of the needle assembly are controlled as the liquid anticoagulant is ultra-sonically atomized to the interior portion of the needle assembly.
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.
