Medical device for analyte monitoring and drug delivery

• US 7,291,497 B2
• Filed: 09/10/2004
• Issued: 11/06/2007
• 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., Roy, Shaunak, Wang, Chengwang, Howard, John
• Primary Examiner(s): Le; Long V.
• Assistant Examiner(s): DiRamio; Jacqueline A.
• Application Number:
  US10/937,872
• Publication Number:
  US 20050100937A1
• Time in Patent Office: 1,152 Days
• Field of Search: 604/65, 604/66, 604/67, 604/267, 604/272, 604/191, 604/890.1, 604/891.1, 435/6, 435/7.1, 435/287.1, 435/287.2, 702/19, 424/422, 424/449, 422/68.1
• US Class Current: 435/287.2
• 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 medical device comprising a disposable patch capable of detecting an analyte of unknown concentration in a bodily fluid, said patch comprising:

at least one microneedle capable of obtaining a sample of a bodily fluid;

a buffer reservoir;

a microchannel having at least a first inlet, a second inlet, and a microarray attached onto the microchannel, said microarray comprising at least one bioactive agent, wherein the first inlet is in fluid communication with the at least one microneedle and channels a flow of bodily fluid into the microchannel, and wherein the second inlet channels a flow of buffer from said buffer reservoir into the microchannel, such that the analyte in the bodily fluid diffuses into the flow of buffer to effect an interaction between the bioactive agent and the analyte therein;

a microarray scanning device to detect the interaction between the bioactive agent and the analyte in the bodily fluid; and

an interface device capable of facilitating communications between said microarray scanning device and a biometric recognition device.

2. The medical device of claim 1, wherein the microarray comprises an antibody specifically binding the analyte in the bodily fluid.

3. The medical device of claim 1, wherein the biometric recognition device is located outside of the device and the communication is through wireless transmission.

4. The medical device of claim 1, wherein the device is worn on the skin as a patch.

5. The medical device of claim 1, further comprising:

a reservoir having a therapeutic agent therein; and

a therapeutic agent releasing device, capable of controlling release of a therapeutic agent from a reservoir in response to an instruction from the biometric recognition device.

6. The medical device of claim 1 wherein the bodily fluid is blood.

7. The medical device of claim 1 wherein the patch comprises a plurality of microneedles.

8. The medical device of claim 1 wherein the microneedle is between about 10 and about 200 microns in diameter.

9. The medical device of claim 1 wherein the microneedle is capable of drawing about 100 nanoliters of blood.

10. The medical device of claim 1 wherein the analyte in the bodily fluid competitively displaces labeled analyte from binding the biological agent.

11. The medical device of claim 10 wherein the labeled analyte is provided in a predetermined amount.

12. The medical device of claim 10 wherein the labeled analyte is labeled with a fluorescent moiety.

13. The medical device of claim 1 wherein the microarray scanning device comprises a total internal reflection fluorescence (TIRF) spectrometer.

14. The medical device of claim 1 wherein the analyte is insulin and the bioactive agent is an antibody specific for insulin.

15. The medical device of claim 1 wherein the analyte is glucose and the bioactive agent is an antibody specific for glucose.

16. The medical device of claim 5 wherein the analyte is glucose and the therapeutic agent is insulin.

17. The medical device of claim 5 wherein the analyte is the same as the therapeutic agent.

18. The medical device of claim 5 wherein the analyte is a metabolite of the therapeutic agent.

19. The medical device of claim 1 comprising at least one disposable assay device comprising the at least one microneedle and the microchannel;

and a non-disposable assay reader device comprising the microarray scanning device and the interface device.

20. The medical device of claim 19 wherein the assay device and assay reader device are in optical communication with one another.

21. The medical device of claim 19 wherein there are a plurality of disposable assay devices fitted in a single assay reader device.

22. The medical device of claim 1 wherein the microarray scanning device detects evanescent wave.