Devices and Methods for Accessing and Analyzing Physiological Fluid

Abstract

Systems, devices and methods for determining the concentration of physiological fluid analytes are provided. The subject systems have a plurality of biosensor devices present on a disposable cartridge. Each biosensor device includes a biosensor and a skin penetration means. In practicing the subject methods, a movement means of the device is used to move each biosensor device in a first direction that provides for penetration of the skin-piercing means into a skin layer followed by movement of the biosensor in a second direction that provides for removal of the skin-piercing means from the skin layer, where this movement profile provides for physiological fluid access and analyte concentration determination by the analyte sensor means. The subject systems, devices and methods for using the same find use in determining the concentration of a variety of different physiological fluid analytes, and are particularly suited for use in detection of physiological fluid glucose concentration.

Description

FIELD OF THE INVENTION [0001] The field of this invention is analyte concentration detection, particularly physiological fluid access and the determination of one or more analyte concentrations thereof. BACKGROUND OF THE INVENTION [0002] Analyte detection in physiological fluids, e.g., blood or blood derived products, physiological fluid, etc., is of ever increasing importance to today's society. Analyte detection assays find use in a variety of applications, including clinical laboratory testing, home testing, etc., where the results of such testing play a prominent role in diagnosis and management in a variety of disease conditions. Analytes of interest include glucose for diabetes management, cholesterol, and the like. In response to this growing importance of analyte detection, a variety of analyte detection protocols and devices for both clinical and home use have been developed. [0003] In determining the concentration of an analyte in a physiological sample, a physiological sa...

AI Technical Summary

Benefits of technology

[0013] While the biosensor devices translate along with the cartridge device, in some embodiments, each biosensor device is operatively attached to the cartridge device so as to be movable relative to the cartridge device so as to optimize the angle by which the skin is to be pierced by the skin-piercing means, thereby reducing pain to the patient and trauma to the skin. Such movement involves deflection and / or rotation of a biosensor device about an axis which extends radially or perpendicular to the path through which the biosensors are caused to travel upon translation of the cartridge device. The movement of the biosensor devices relative to the cartridge is primarily accomplished passively such as by components fixed within the housing structure relative to the cartridge for advancing or deflecting each individual biosensor / skin-piercing / fluid access device through the housing aperture towards an access site on the user, penetrating the access site with the skin-piercing element and then withdrawing or retracting the device from the access site. Such components include but are not limited to ramp structures and clip mechanisms.

[0016] The subject systems, devices and methods for using the same find use provide a repeatable fluid accessing and sampling interface between a biosensor and a target skin site for determining a chemical characteristic of the sampled fluid, typically, the concentration of a variety of different physiological fluid analytes, and most typically the concentration of glucose. The subject system and devices can be used in the continual measurement of an analyte of interest without the problems experienced with implantable analyte sensors. For example, because single-use substantially painless analyte measurement means are employed, user irritation and pain are avoided. Furthermore, the individual measurement means employed need not be calibrated prior to use. In addition, with respect to the glucose the subject devices and methods can not only be employed to rapidly and accurately detect the occurrence of a hypo or hyperglycemic event without host participation or intervention, but they can also be employed to readily predict the occurrence of hypo and hyperglycemic conditions, and therefore provide for improved management of blood glucose metabolism associated disease conditions. As such, the subject invention represents a significant contribution to the art.

Problems solved by technology

Obtaining the sample often involves cumbersome and complicated devices which may not be easy to use or may be costly to manufacture.

Furthermore, the procedure for obtaining the sample may be painful.

For example, pain is often associated with the size of the needle used to obtain the physiological sample and the depth to which the needle is inserted.

Because of these disadvantages, it is not uncommon for patients who require frequent monitoring of an analyte to simply become non-compliant in monitoring themselves.

With diabetics, for example, the failure to measure their glucose level on a prescribed basis results in a lack of information necessary to properly control the level of glucose.

Uncontrolled glucose levels can be very dangerous and even life threatening.

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