Medical device for analyte monitoring and drug delivery
The invention relates to an ingestible, implantable or wearable medical device comprising a microarray which comprises a bioactive agent capable of interacting with a disease marker biological analyte; a reservoir which comprises at least one therapeutic agent and is capable of releasing the therapeutic agent(s) from the medical device; and a plurality of microchips comprising a microarray scanning device capable of obtaining physical parameter data of an interaction between the disease marker biological analyte with the bioactive agent; a biometric recognition device capable of comparing the physical parameter data with an analyte interaction profile; optionally a therapeutic agent releasing device capable of controlling release of the therapeutic agent from the reservoirs; an interface device capable of facilitating communications between the microarray scanning device, biometric recognition device and the therapeutic agent releasing device; and an energy source to power the medical device. Specifically, the invention relates to a medical device capable of detecting an analyte in a bodily fluid comprising at least one microneedle capable of obtaining a sample of a bodily fluid, a first microchannel through which the sample flows and is in fluid communication with the at least one microneedle, a second microchannel in fluid communication with the first microchannel, through which a buffer flows, wherein the second channel comprises a microarray with a bioactive agent, a microarray scanning device to detect an interaction between the bioactive agent and the analyte in the bodily fluid; and an interface device.
1. A method of detecting and/or treating a disease in a patient comprising:
A) contacting an ingestible medical device with a bodily fluid by administering said device to a patient, said device having an exterior surface and an interior surface and comprising:
a) a microarray of miniature test sites configured to fluidically communicate with the bodily fluid of the patient, wherein said microarray comprises a plurality of the test sites on a continuous surface, each site of said plurality comprising a polypeptide bioactive agent immobilized thereon to effect an interaction with a disease marker suspected to be present in the bodily fluid;
b) a reservoir comprising a therapeutic agent;
c) an optical microarray scanning device that is configured to optically detect signals from the plurality of test sites on the continuous surface, wherein the signals are indicative of a physical parameter indicative of the disease marker based on an interaction between the disease marker and said polypeptide bioactive agents at said plurality of test sites;
d) a biometric recognition device that is configured to compare said physical parameter data with an analyte interaction profile;
e) a therapeutic agent releasing device that is configured to control release of at least one therapeutic agent from said reservoir;
f) an interface device that is configured to facilitate communication between said microarray scanning device and said biometric recognition device; and
g) a biocompatible polymer coating, coated on the exterior surface of said ingestible medical device, facilitating said device to pass through an intestinal tract; and
B) operating said ingestible medical device to obtain the physical parameter indicative of the presence of said disease; and optionally
C) releasing said therapeutic agent to said patient.
2. The method of claim 1 , wherein the biocompatible polymer coating has channels.
3. The method of claim 1 , wherein the biocompatible polymer coating is porous.
4. The method of claim 1 , wherein the microarray comprises microbeads.
5. The method of claim 1 , wherein the plurality of bioactive agents are monoclonal antibodies.
6. The method of claim 1 , wherein the plurality of bioactive agents are immunoglobulins.
7. The method of claim 1 , wherein the plurality of bioactive agents are fluorescently labeled.
8. The method of claim 1 , wherein the plurality of bioactive agents are fluorescently labeled with a nanocrystal.
9. The method of claim 1 , wherein the disease marker is a nucleic acid.
10. The method of claim 1 , wherein the disease marker is a polypeptide.
11. The method of claim 10 , wherein the disease marker is an immunoglobulin.
12. The method of claim 1 , wherein one or more of the microarray scanning device, biometric recognition device, therapeutic device and interface device comprise silicon germanium.
13. The method of claim 1 , wherein the microarray scanning device comprises fiber optic elements.
14. The method of claim 1 , wherein the analyte interaction profile is stored in the biometric recognition device.
15. The method of claim 1 , wherein the analyte interaction profile is stored on an external device separate from the medical device.
16. The method of claim 1 , wherein the reservoir is configured to release said at least one therapeutic agent from said medical device.
17. The method of claim 1 , wherein the interface device comprises a personal area network.
18. The method of claim 1 , further comprising an energy source to power the medical device.
19. The method of claim 18 , wherein the energy source is provided by a personal area network.
20. The method of claim 1 , wherein the communications are monitored by an external computer.
21. The method of claim 20 , wherein the external computer directs release of the therapeutic agent.
22. The method of claim 1 , further comprising comparing said physical parameter to the analyte interaction profile to facilitate detection of said disease.
23. The method of claim 1 , wherein the disease marker is a biological analyte.
24. The method of claim 1 , wherein the plurality of bioactive agents comprise the same bioactive agents.
25. The method of claim 1 , wherein the plurality of bioactive agents comprise different bioactive agents.
26. The method of claim 1 , wherein the therapeutic agent is specific to a toxin or disease.
27. The method of claim 1 , wherein the therapeutic agent is selected based on the detected disease marker.
28. The method of claim 1 wherein the releasing of the therapeutic agent is based on a detected concentration of the disease marker.
29. The method of claim 1 , wherein the microarray is configured to automatically interact with a gastric fluid when ingested by the subject.
30. The method of claim 29 , wherein the medical device is configured to transmit information of said interaction to an external source.
31. The method of claim 1 , wherein the plurality of the test sites are simultaneously exposed to a sample suspected to contain the disease marker upon ingestion by the subject.
32. The method of claim 1 , wherein the microarray scanning device is a camera.