Medical device for analyte monitoring and drug delivery

• US 8,202,697 B2
• Filed: 08/12/2005
• Issued: 06/19/2012
• Est. Priority Date: 09/11/2003
• Status: Active Grant

• Current Assignee: Labrador Diagnostics LLC (SoftBank Group Corp.)
• Original Assignee: Theranos Incorporated
• Inventors: Holmes, Elizabeth A.
• Primary Examiner(s): LAM, ANN Y
• Application Number:
  US11/202,231
• Publication Number:
  US 20060062852A1
• Time in Patent Office: 2,503 Days
• Field of Search: 422/61, 422/68.1, 435/4, 435/6, 435/7.1, 435/287.1, 435/287.2, 435/286.1, 435/286.4, 436/501, 436/518, 436/807, 436/55, 436/811
• US Class Current: 435/7.1
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14556 by fluorescence A61B5/14555 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1477 non-invasive
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150343 : Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150854 : long distance, e.g. between patient's home and doctor's office
• CPC Class Codes: A61B 5/150862 : intermediate range, e.g. within room or building
• CPC Class Codes: A61B 5/15087 : short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150969 : Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
• CPC Class Codes: A61B 5/150984 : Microneedles or microblades
• CPC Class Codes: A61B 5/15107 : Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15117 : comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15119 : comprising shape memory alloys
• CPC Class Codes: A61B 5/15121 : comprising piezos
• CPC Class Codes: A61B 5/15123 : comprising magnets or solenoids
• CPC Class Codes: A61B 5/15125 : comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/1519 : comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/417 : the bone marrow
• CPC Class Codes: A61B 5/4238 : stomach
• CPC Class Codes: A61B 5/4839 : combined with drug delivery
• CPC Class Codes: A61B 5/4848 : Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/685 : Microneedles
• CPC Class Codes: A61B 5/6865 : Access ports
• CPC Class Codes: A61B 5/7282 : Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61M 2005/14513 : with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2005/1726 : the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2037/0023 : Drug applicators using microneedles
• CPC Class Codes: A61M 2205/0244 : Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 37/0015 : by using microneedles
• CPC Class Codes: A61M 5/14276 : specially adapted for implantation
• CPC Class Codes: B01L 2200/10 : Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/023 : Sending and receiving of information, e.g. using bluetooth
• CPC Class Codes: B01L 2300/024 : Storing results with means integrated into the container
• CPC Class Codes: B01L 2300/0636 : Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0654 : Lenses; Optical fibres
• CPC Class Codes: B01L 2300/0816 : Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2400/0406 : capillary forces
• CPC Class Codes: B01L 2400/0415 : electrical forces, e.g. electrokinetic
• CPC Class Codes: B01L 2400/0472 : Diffusion
• CPC Class Codes: B01L 2400/0487 : fluid pressure, pneumatics
• CPC Class Codes: B01L 3/5027 : by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502707 : characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/502761 : specially adapted for handling suspended solids or molecules independently from the bulk fluid flow, e.g. for trapping or sorting beads, for physically stretching molecules investigating characteristics of particles G01N15/00
• CPC Class Codes: B01L 3/502776 : specially adapted for focusing or laminating flows
• CPC Class Codes: G01N 2035/00158 : Elements containing microarrays, i.e. "biochip"

Abstract

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.

Claims

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.