Sampling devices and methods involving relatively little pain

摘要

Systems and methods for delivering and/or receiving a substance or substances, such as blood, from subjects. In one embodiment, devices and methods for receiving blood from a subject employ devices including a substance transfer component (such as one or more microneedles), and a storage chamber having an internal pressure less than atmospheric pressure prior to receiving blood. In certain embodiments, substances may be received from and/or delivered to the subject with relatively little pain. The pain may be assessed, for example, using pain scales such as the WONG BAKER FACES Pain Scale. The device may be self-contained, applied to the skin, and activated to receive blood from the subject. The device, or a portion thereof, may be processed to determine the blood and/or an analyte within the blood using sensors or agents in the device or an external apparatus. Other aspects of the present invention are directed at other devices for receiving bodily fluids kits involving such devices, methods of making such devices, methods of using such devices, and the like.

主权项

1. A device for receiving blood or other substance from the skin of a subject, the device comprising:
a housing; a device actuator; a substance transfer component including an opening for receiving blood from the skin of the subject, the substance transfer component also including at least three needles having a length of 500-1500 microns, the needles being moveable relative to the housing such that actuation of the device actuator moves the needles relative to the housing; a self-contained, sealed vacuum chamber containing a vacuum prior to movement of any component of the device relative to the housing during use of the device for receiving blood or other substance from the subject; a flow path between the vacuum chamber and the at least three needles of the substance transfer component; a flow controller to control fluid communication along the flow path; and a vacuum actuation component configured to open the flow controller to enable fluid communication through the flow path, the vacuum actuation component being distinct from the at least three needles, wherein the device actuator is positioned at least partially in the vacuum chamber,
wherein the device is constructed and arranged to insert at least a portion of the needles into the skin, and to apply vacuum from the vacuum chamber to the skin to receive blood from the subject, and wherein an average pain indication experienced from a 10 microliter blood sampling using the device is less than an average pain indication experienced from a 10 microliter blood sampling using a standard spring-loaded 21-gauge retractable finger lancet, wherein both average pain indications are measured from at least 10 subjects using the WONG-BAKER FACES Pain Scale.