Medical device for analyte monitoring and drug delivery

Patent metadata

Field	Value
Publication number	US-10130283-B2
Application number	US-201514816426-A
Country	US
Kind code	B2
Filing date	Aug 3, 2015
Priority date	Sep 11, 2003
Publication date	Nov 20, 2018
Grant date	Nov 20, 2018

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.

First claim

What is claimed is:

1. An ingestible medical device, comprising:
a microchip enclosed in the ingestible medical device, the microchip comprising an interface device that is configured to wirelessly transmit a signal that is generated upon interaction of the device with gastric fluid to an external device located outside the subject, and is configured to transmit a physiological condition of the subject and
a biocompatible coating covering at least a portion of the device, wherein a portion of the coating is characterized by interconnected pores of sufficient size to allow for flow of bodily fluids into the ingestible medical device and another portion of the coating covering a larger portion of device that is not porous,
wherein in response to being ingested by a subject, the device is configured to interact with a gastric fluid, and
wherein the device is configured to measure the physiological condition of the subject.

2. The device of claim 1 , further comprising a therapeutic agent releasing device having a reservoir to control the release of a therapeutic agent.

3. The device of claim 2 , wherein the therapeutic agent releasing device signals the external device a status of therapeutic agent release.

4. The device of claim 1 , wherein the external device is a computer.

5. The device of claim 4 , wherein the external device is in communication with an external network.

6. The device of claim 1 , wherein the interface device comprises a personal area network.

7. The device of claim 1 , wherein the signal indicates a bio-electric, bio-magnetic, or biochemical characteristic of the device's interaction with the gastric fluid.

8. The device of claim 1 , further comprising:
an identifier that identifies an analyte at a target site,
wherein the interface device is configured to transmit a signal that identifies the analyte.

9. The device of claim 8 , wherein the identifier identifies the analyte in real time.

10. The device of claim 8 , wherein the analyte is a drug or drug metabolite.

11. The device of claim 8 , wherein the target site is along a path of digestion where the device interacts with gastric juices.

12. The device of claim 8 , further comprising:
a therapeutic agent releasing device having a reservoir configured to control the release of a therapeutic agent.

13. The device of claim 8 , wherein the therapeutic agent releasing device signals the external device a status of therapeutic agent release.

14. The device of claim 8 , wherein the external device is worn on the skin as a patch.

Assignees

• Theranos Ip Co Llc
• Theranos Ip Co Llc

Inventors

• Holmes Elizabeth A
• Roy Shaunak
• Howard John
• Wang Chengwang

Classifications

• A61M5/14276

  specially adapted for implantation · CPC title

• B01L2400/0472

  Diffusion · CPC title

• A61B5/15125

  comprising a vacuum or compressed fluids · CPC title

• A61B5/14514

  using means for aiding extraction of interstitial fluid, e.g. microneedles or suction · CPC title

• B01L2400/0487

  fluid pressure, pneumatics · CPC title