Physiological sample collection devices and methods of using...

G - Physics – 01 – N

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G01N 21/78 (2006.01) A61B 5/15 (2006.01) A61B 17/34 (2006.01) G01N 27/327 (2006.01) G01N 27/416 (2006.01) G01N 33/487 (2006.01)

Patent

CA 2428365

Devices, systems and methods are provided for piercing the skin, accessing and collecting physiological sample therein, and measuring a characteristic, e.g., an analyze concentration, of the sampled physiological sample. The subject devices are in the form of a test strip which include a biosensor and at least one skin-piercing element which is a planar extension of a portion of the biosensor. At least one fluid pathway resides within a portion of the biosensor and within the skin-piercing element. The skin-piercing element has a space- defining configuration therein which acts as a sample fluid pooling area upon penetration into the skin. Systems are provided which include one or more test strip devices and a meter for making analyte concentration measurements. Methods for using the devices and systems are also provided.

L'invention porte sur des dispositifs, des systèmes et des méthodes permettant de percer la peau, d'y accéder et d'y recueillir un échantillon physiologique, et de mesurer une caractéristique, p. ex., déterminer la concentration d'un échantillon physiologique prélevé. Les dispositifs se présentent sous la forme d'une bandelette qui comprend un biocapteur et au moins un élément perçant la peau se prolonge dans le plan d'une partie du biocapteur. Au moins un trajet du liquide se situe à l'intérieur d'une partie du biocapteur et à l'intérieur de l'élément perçant la peau. L'élément perçant la peau présente une configuration définissant un volume, lequel tient lieu de récipient recueillant l'échantillon sous forme liquide après la pénétration de l'élément dans la peau. Les systèmes comprennent une ou plusieurs bandelettes et un dispositif de mesure déterminant la concentration de l'analyte. L'invention porte aussi sur des méthodes permettant d'utiliser les dispositifs et les systèmes.

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