Devices and methods for extracting bodily fluid

Abstract

A bodily fluid extraction device includes a penetration member configured for penetrating a target site and subsequently residing within the target site and extracting a bodily fluid sample. The penetration member includes a proximal end adapted for fluid communication with an analyte analysis system, a distal end, and a channel extending from the distal to the proximal end. The distal end includes a sharp portion for penetrating a target site, and a flexible feature adapted for promoting bodily fluid flow into the channel by protruding into the target site after the penetration member has penetrated the target site. A method for extracting bodily fluid includes providing a bodily fluid extraction device as described immediately above. Subsequently, a target site is penetrated with the distal end of the bodily fluid extraction device's penetration member and the flexible portion of the penetration member is caused to protrude into the target site and promote bodily fluid flow into the penetration member's channel. Bodily fluid (e.g., ISF) is then extracted from the target site (e.g., a dermal tissue target site) via the channel of the bodily fluid extraction device.

Description

technical field [0001] The present invention relates generally to apparatus and methods for extracting bodily fluids, and more particularly to apparatus and methods for facilitating the flow of bodily fluids in a continuous or semi-continuous manner during the extraction of bodily fluids. Background technique [0002] In recent years, efforts in medical device research for monitoring the concentration of analytes (eg, glucose) in body fluids (eg, blood and interstitial fluids) have focused on developing devices and methods that allow continuous or semi-continuous monitoring. [0003] In the field of blood glucose monitoring, devices and methods of continuous or semi-continuous monitoring are advantageous because they provide enhanced insight into trends in blood glucose concentrations, effects of foods and medications on blood glucose concentrations, and control of a user's overall blood glucose. In practice, however, continuous or semi-continuous monitoring equipment may ha...

AI Technical Summary

Problems solved by technology

In practice, however, continuous or semi-continuous monitoring equipment may have disadvantages

For example, during extraction of interstitial fluid (ISF) from a target site (e.g., a user's skin tissue target site) through a sampling module of a medical device, the amount and / or flow rate of the interstitial fluid may be insufficient, and the user may feel discomfort

[0004] Additionally, continuous and semi-continuous monitoring equipment can be affected by a deleterious effect known as "sensor hysteresis"

Such sensor hysteresis occurs when there is a large difference between the concentration of the analyte at the sensor of the continuous monitoring device and the real-time analyte concentration at the target site

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