Systems and methods for monitoring pharmacological parameters
This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.
1 . A system for monitoring more than one pharmacological parameter useful for assessing efficacy and/or toxicity of a therapeutic agent, comprising:
a) a fluidic device comprising a cartridge, said cartridge comprising at least one sample collection unit and an assembly; wherein said sample collection unit allows a sample of bodily fluid comprising a plurality of analytes indicative or said more than one pharamcological parameter to react with reactants contained within said assay assembly, said reaction yields detectable signals indicative of the values of the more than one pharmacological parameter from said sample of bodily fluid;
b) a reader assembly comprising a detection assembly for detecting said detectable signals; and
c) a communication assembly for transmitting said detected signals to an external device.
2 . The system of claim 1 , wherein the fluidic device generates the detectable signals based on a protocol transmitted from an external device.
3 . The system of claim 2 , wherein the protocol is transmitted wirelessly.
4 . The system of claim 1 , wherein the fluidic device further comprises an identifier to provide the identity of said fluidic device that is adapted to trigger the transmission of said protocol.
5 . The system of claim 1 , wherein said protocol varies depending on the identify of said fluidic device that is recognizable by an identifier detector.
6 . The system of claim 1 , wherein the sample of bodily fluid is less than about 500 ul.
7 . The system of claim 1 , wherein the sample of bodily fluid is less than about 50 ul.
8 . The system of claim 1 , wherein the reactants comprises immunoassay reagents.
9 . The system of 8 , wherein the immunoassay reagents detect a polypeptide glycoprotein, polysaccharide, lipid, nucleic acid, and a combination thereof.
10 . The system of claim 8 , wherein the immunoassay reagents detect a member selected from the group consisting of drug, drug metabolite, biomarkers indicative of a disease, tissue specific marker, and biomarker specific for a cell or cell type.
11 . The system of claim 1 , wherein the plurality of analytes are identified by distinct signals detectable over a range of 3 orders of magnitude.
12 . The system of claim of claim 1 , wherein the detectable signal is a luminescent signal.
13 . The system of claim of claim 1 , wherein the detectable signal is a chemiluminescent signal.
14 . The system of claim 1 , wherein the fluidic device further comprises a microneedle for obtaining the sample of bodily fluid.
15 . The system of claim of claim 1 , wherein the pharamcological parameter is a pharmacokinetic parameter.
16 . The system of claim of claim 1 , wherein the pharamcological parameter is a pharmacodynamic parameter.
17 . The system of claim 1 , wherein at least one of the plurality of the analytes is a biomarker indicative of a pharmacodynamic parameter.
18 . The system of claim 1 , wherein at least one of the plurality of the analytes is the therapeutic agent or a metabolite of the therapeutic agent that is indicative of a pharmacokinetic parameter.
19 . The system of claim of claim 1 , wherein said fluidic device communicates data relating to said signal via a wireless transmitter.
20 . The system of claim 19 , wherein said wireless transmitter comprises a cell phone.
21 . A method of monitoring more than one pharmacological parameter useful for assessing efficacy and/or toxicity of a therapeutic agent, comprising:
a) subjecting a sample of bodily fluid from a subject administered with the pharmaceutical agent to a fluidic device for profiling said more than one pharmacological parameter, said fluidic medical device comprising
a cartridge, said cartridge comprising at least one sample collection unit, and an assay assembly comprising reaction reagents;
b) actuating said fluidic device and directing said immunoassay reagents within said fluidic device;
c) allowing said sample of bodily fluid to react with immunoassay reagents to yield detectable signals indicative of the values of the more than one pharmacological parameter from said sample;
d) detecting said detectable signal generated from said sample of bodily fluid.
22 . The method of claim 21 , further comprising the step of repeating the steps of (a)-(d) at a time interval prompted by a wireless signal communicated to said subject.
23 . The method of claim 21 , wherein the more than one pharmacological parameter comprises both a pharmacokinetic indicator and a pharmacodynamic indicator useful for accessing efficacy and/or toxicity of the therapeutic agent.
24 . The method of claim 21 , wherein the pharmacological parameter is a pharmacokinetic indicator.
25 . The method of claim 21 , wherein the pharmacological parameter is a pharmacodynamic indicator.
26 . The method of claim 21 , wherein the pharmacological parameter is reflected by concentration of the therapeutic agent.
27 . The method of claim 21 , wherein the pharmacological parameter is reflected by concentration of a metabolite of the therapeutic agent.
28 . The method of claim 21 , wherein the pharmacological parameter is reflected by a biomarker affected directly or indirectly by the therapeutic agent.
29 . The method of claim 21 , wherein the pharmacological parameter is reflected by a biomarker that indicates an adverse reaction to the therapeutic agent.