PATIENT-ENACTED SAMPLING TECHNIQUE
The present invention is generally directed to systems and methods for sampling fluids from subjects. The fluid may be any suitable bodily fluid, e.g., blood or interstitial fluid. In some cases, the subject is a patient. The subject may have a device that can be applied to the skin of the subject (e.g., by the subject, or another person), and the device is able to obtain a sample of fluid. The fluid may be stored within a reservoir in the device, and the fluid may be obtained from the subject at any convenient time, e.g., at home, away from a healthcare setting, etc. In some embodiments, the device, or a portion thereof, may be returned to a clinical and/or laboratory setting to analyze the fluid stored within the device.
1 - 91 . (canceled)
92 . A device for receiving bodily fluid from a subject, the device comprising:
a fluid transporter comprising a microneedle;
a fluid storage reservoir in fluidic communication with the fluid transporter; and
an indicator indicative of the time fluid is contained within the fluid storage reservoir.
93 . The device of claim 92 , wherein the indicator is able to record the time when fluid enters the fluid storage reservoir.
94 . The device of claim 92 , wherein the indicator is able to record the duration fluid is present within the fluid storage reservoir.
95 . The device of claim 92 , wherein the indicator is able to produce a signal indicative of a condition of fluid within the fluid storage reservoir.
96 . The device of claim 95 , wherein the signal includes a visual signal.
97 . The device of claim 95 , wherein the signal includes a color signal.
98 . The device of claim 92 , wherein the indicator is activated upon activation of the device.
99 . The device of claim 92 , wherein the indicator is activated upon introduction of fluid into the fluid storage reservoir.
100 . The device of claim 92 , wherein the indicator is in electronic communication with a sensor in sensing communication with the fluid storage reservoir.
101 . The device of claim 92 , wherein the device is able to apply a vacuum to the subject to withdraw fluid into the fluid storage reservoir.
102 . The device of claim 92 , wherein the device further comprises a self-contained vacuum chamber in fluidic communication with the fluid storage reservoir.
103 . The device of claim 92 , wherein the device further comprises an activator able to activate withdrawal of fluid from the subject into the fluid storage reservoir.
104 . The device of claim 103 , wherein the activator is activated by pressing a button on the device.
105 . The device of claim 103 , wherein the activator is activated upon applying the device to the skin of the subject.
106 . The device of claim 103 , wherein the activator is activated upon removal of the device from packaging containing the device.
107 . The device of claim 92 , wherein the device is able to determine an analyte contained within fluid from the skin and/or from beneath the skin of the subject into the fluid storage reservoir.
108 . The device of claim 107 , wherein the fluid comprises blood.
109 . The device of claim 107 , wherein the fluid comprises interstitial fluid.
110 . The device of claim 92 , wherein the device further comprises an anticoagulant for fluid from the subject.
111 . The device of claim 92 , wherein the device comprises a first module and a second module, wherein the first module comprises a support structure comprising the fluid transporter and the fluid storage reservoir, and the second module comprises a signal structure comprising the indicator.
112 . The device of claim 111 , wherein the first module and the second module are constructed and arranged to be disconnectable without the use of tools.