Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) placing a blood collection device over a region on the surface of the skin from which said sample is to be obtained, (b) forming a seal between said blood collection device and said surface of the skin, (c) creating a vacuum sufficient to result in said surface of the skin becoming stretched and engorged with blood, (d) triggering a lancing assembly and causing a lancet to penetrate said skin, (e) retracting said lancet, (f) withdrawing blood toward and onto a fluid collector, and (g) releasing the vacuum. In another aspect of the invention, an apparatus for carrying out the method described previously is provided.

Abstract: The present invention involves apparatus and methods for use in collecting bodily fluids, such as interstitial fluids, from the epidermal layer of an animal. A preferred apparatus includes a pressure head and, optionally, a holder therefor for supplying a positive pressure to the head. The methods include the application of a positive pressure to the area surrounding an epidermal site from which stratum corneum has been breached, such as by laser ablation, to cause bodily fluids, such as interstitial fluids, to exude from the site and collecting the fluids exuding therefrom.

Abstract: The present invention involves apparatus and methods for use in collecting bodily fluids, such as interstitial fluids, from the epidermal layer of an animal. A preferred apparatus includes a pressure head and, optionally, a holder therefor for supplying a positive pressure to the head. The methods include the application of a positive pressure to the area surrounding an epidermal site from which stratum corneum has been breached, such as by laser ablation, to cause bodily fluids, such as interstitial fluids, to exude from the site and collecting the fluids exuding therefrom.

Abstract: The present invention involves apparatus and methods for use in collecting bodily fluids, such as interstitial fluids, from the epidermal layer of an animal. A preferred apparatus includes a pressure head and, optionally, a holder therefor for supplying a positive pressure to the head. The methods include the application of a positive pressure to the area surrounding an epidermal site from which stratum corneum has been breached, such as by laser ablation, to cause bodily fluids, such as interstitial fluids, to exude from the site and collecting the fluids exuding therefrom.

Abstract: An article and a method for monitoring the concentration of an analyte, e. g., glucose, in blood. In one aspect, the invention involves an article comprising a multiple-layer element. In one embodiment, the article comprises: a multiple-layer element comprising: (a) a base layer (b) a cover layer, the cover layer having a first opening for venting the multiple-layer element and a second opening for receiving a biological sample; and (c) a core layer having a first major surface and a second major surface, the core layer disposed between the base layer and the cover layer, the core layer comprising a sample introduction chamber and a optical reading chamber, the first major surface of the core layer in face-to-face contact with the base layer, the second major surface of the core layer in face-to-face contact with the cover layer.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) placing a blood collection device over a region on the surface of the skin from which said sample is to be obtained, (b) forming a seal between said blood collection device and said surface of the skin, (c) creating a vacuum sufficient to result in said surface of the skin becoming stretched and engorged with blood, (d) triggering a lancing assembly and causing a lancet to penetrate said skin, (e) retracting said lancet, (f) withdrawing blood toward and onto a fluid collector, and (g) releasing the vacuum. In another aspect of the invention, an apparatus for carrying out the method described previously is provided.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of: (a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and (b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises: (a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and (b) a vacuum pump. Preferably, the apparatus also includes a housing. In another aspect of this invention, an article is provided for an article capable of both collecting blood and detecting an analyte in that blood is provided.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:(a) placing a blood collection device over a region on the surface of the skin from which said sample is to be obtained,(b) forming a seal between said blood collection device and said surface of the skin,(c) creating a vacuum sufficient to result in said surface of the skin becoming stretched and engorged with blood,(d) triggering a lancing assembly and causing a lancet to penetrate said skin,(e) retracting said lancet,(f) withdrawing blood toward and onto a fluid collector, and(g) releasing the vacuum.In another aspect of the invention, an apparatus for carrying out the method described previously is provided.

Abstract: Method and apparatus for obtaining a sample of blood from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of:(a) forming an unobstructed opening in the area of the skin from which the sample of blood is to be extracted; and(b) extracting the sample of blood from the unobstructed opening in the skin, with the aid of a vacuum and a stretching of the skin.In another aspect of the invention, an apparatus for carrying out the method described previously is provided. The apparatus comprises:(a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted, preferably a lancing assembly; and(b) a vacuum pump.Preferably, the apparatus also includes a housing.In another aspect of this invention, an article is provided for an article capable of both collecting blood and detecting an analyte in that blood is provided.

Abstract: The present disclosure provides the use of vacuum to enhance the transdermal transport of fluids in sampling methods for the detection of analytes in a patient's blood.

Abstract: The present invention relates to analytical devices for determining the presence or amount of an analyte in a test sample. The analytical devices comprise an inlet port, a vent, a channel, and an array of structures. The structures have immobilized reagent covalently or non-covalently attached to the surface of the structures. The immobilized reagent captures analyte in the test sample where it is detected by a detection system. The present invention also provides methods and reagents for performing assays utilizing the analytical devices of the present invention. The present invention also provides methods of manufacturing the analytical devices of the present invention.

Abstract: A process of calibrating an individual in preparation for the non-invasive measurement of an biological compound across the skin of that individual using non-ionizing radiation is provided. The process includes determining the contribution of one or more skin parameters to the absorption and transmittance data and correcting the subsequent non-invasive measurement of the biological compound for the contribution of the parameter(s).

Abstract: The present invention relates to analytical devices for determining the presence or amount of an analyte in a test sample. The analytical devices comprise an inlet port, a vent, a channel, and an array of structures. The structures have immobilized reagent covalently or non-covalently attached to the surface of the structures. The immobilized reagent captures analyte in the test sample where it is detected by a detection system. The present invention also provides methods and reagents for performing assays utilizing the analytical devices of the present invention. The present invention also provides methods of manufacturing the analytical devices of the present invention.

Abstract: Methods and devices are provided involving an inlet port, at least one chamber, a channel providing access for fluids to flow through via capillary action or differential pressure, reagents, detection means and self-venting materials. The devices allow for the appropriate mixing, reacting, incubating needed to give a detectable signal which can be read. The self-venting materials allow for the 1) displacement of gases inside a track to the outside of the device and 2) oxygen movement into the track from the outside.

Abstract: A sensor for measuring the concentration of an analyte in a solution is disclosed. The sensor may be adapted for use as either an amperometric or a potentiometric sensor. It includes a membrane having a biologically active protein immobilized within. The membrane is attached and reliably sealed to a housing by means of ultrasonic welding, either directly or indirectly. Further, the membrane may be compressed to a fraction of its original dimensions. Metallic parts of the device may, optionally, be physically isolated from the sample solution to reduce corrosion. These features operate synergistically so that the claimed device exhibits relatively fast response and recovery times, is reliably leak-proof, and may be constructed in relatively small sizes.

Abstract: An ion-selective electrode having an electrically insulating substrate with a substantially planar first surface, and having a non-metallic conductor for sensing a potential affixed to the first surface beneath an ion-sensitive membrane. An electrically insulating layer covers at least a portion of the non-metallic conductor and means for making electrical contact with the non-metallic conductor.

Abstract: A membrane anchor for an ion-selective electrode may be formed by intersolubilizing an ion-selective membrane lying above a sensing pad with a region of thermoplastic material laterally disposed around the membrane. A first layer of electrically insulating thermoset material lies beneath the thermoplastic material and in intimate contact with an electrically insulating substrate. A second layer of exposed thermoset material lies above the thermoplastic material and contacts the first layer of thermoset material around the entire lateral perimeter of the thermoset material.The membrane anchor may be usefully employed with an ion-selective electrode having an electrically insulating substrate with a substantially planar surface and having non-metallic means for sensing a potential affixed to the surface beneath an ion-sensitive membrane.