Wearable, continuous biological fluid monitoring system

Patent metadata

Field	Value
Publication number	US-12484818-B2
Application number	US-202217806899-A
Country	US
Kind code	B2
Filing date	Jun 14, 2022
Priority date	Jun 14, 2021
Publication date	Dec 2, 2025
Grant date	Dec 2, 2025

Abstract

Methods, systems, and apparatus, including biological fluid monitoring systems comprising a microneedle layer; at least one electromagnet assembly; and at least two liquid chambers coupled via a microfluidic layer, wherein the microneedle layer comprises a plurality of microneedles configured to extract interstitial fluid (ISF) from a patient in to one of the at least two liquid chambers, and wherein the at least one electromagnet assembly is configured to a move a test sample of the extracted ISF through the at least two liquid chambers to conduct a test cycle.

First claim

What is claimed is:

1 . A biological fluid monitoring system comprising:
a microneedle layer; at least one electromagnet assembly; and at least two liquid chambers coupled via a microfluidic layer, wherein the microneedle layer comprises a plurality of microneedles configured to extract interstitial fluid (ISF) from a patient in to one of the at least two liquid chambers, and wherein the at least one electromagnet assembly is configured to move a test sample of the extracted ISF through the at least two liquid chambers to conduct a test cycle, wherein the at least two liquid chambers comprise a metering chamber and a sample collection chamber, wherein the microneedles are configured to extract the ISF into the sample collection chamber, and wherein the test cycle comprises:
collecting the test sample of the extracted ISF by moving a portion of the ISF from the sample collection chamber to the metering chamber; and
determining a volume of the test sample.

2 . The biological fluid monitoring system of claim 1 , wherein one of the at least two liquid chambers comprises a test chamber, and wherein the test cycle comprises:
moving the test sample from the metering chamber to the test chamber; and conducting an electrochemical reaction on the test sample.

3 . The biological fluid monitoring system of claim 2 , wherein the at least two chambers comprise a waste chamber, and wherein the test cycle comprises:
moving the test sample to the waste chamber to complete the test cycle.

4 . The biological fluid monitoring system of claim 3 , configured to repeat the test cycle to provide continuous monitoring of the patient.

5 . A biological fluid monitoring system comprising:
a microneedle layer: at least one electromagnet assembly; and at least two liquid chambers coupled via a microfluidic layer, wherein the microneedle layer comprises a plurality of microneedles configured to extract interstitial fluid (ISF) from a patient in to one of the at least two liquid chambers, and wherein the at least one electromagnet assembly is configured to move a test sample of the extracted ISF through the at least two liquid chambers to conduct a test cycle,
wherein each of the at least one electromagnet assemblies comprise an iron core, a wire, and a permanent magnet; wherein the iron core and the wire form an electromagnet having an opposite polarity to the permanent magnet; and wherein the electromagnet is configured to detach, when charged, from the permanent magnet to allow air into a formed pump source chamber.

6 . The biological fluid monitoring system of claim 5 , wherein each of the at least one electromagnet assemblies is coupled to a respective one of the at least two liquid chambers and a valve formed by a valve block; and wherein the electromagnet is configured to generate, when charged, a negative pressure in the respective liquid chamber and open the valve.

7 . The biological fluid monitoring system of claim 6 , wherein the permanent magnet magnetically attracts the electromagnet; wherein the electromagnet is configured to close, when uncharged, the formed pump source chamber forcing the stored air into the respective liquid chamber and closing the valve; and wherein the respective liquid chamber is configured to drive stored liquid into an adjacent one of the at least two liquid chambers via the microfluidic layer as the stored air is received.

8 . The biological fluid monitoring system of claim 7 , wherein the respective liquid chamber is configured to drive excess liquid into one of the at least two liquid chambers via the microfluidic layer.

9 . A biological fluid monitoring system comprising:
a microneedle layer; a pneumatic layer and a membrane, wherein the membrane is positioned between the pneumatic layer and the microneedle layer; at least one electromagnet assembly; and at least two liquid chambers coupled via a microfluidic layer, wherein the microneedle layer comprises a plurality of microneedles configured to extract interstitial fluid (ISF) from a patient in to one of the at least two liquid chambers, and wherein the at least one electromagnet assembly is configured to move a test sample of the extracted ISF through the at least two liquid chambers to conduct a test cycle.

10 . The biological fluid monitoring system of claim 9 , wherein the at least two liquid chambers are formed between the pneumatic layer and the microneedle layer.

11 . The biological fluid monitoring system of claim 9 , configured to be worn by the patient.

12 . The biological fluid monitoring system of claim 11 , wherein a surface of the microneedle layer is configured to be attached to the patient.

13 . A method of conducting a test cycle on interstitial fluid (ISF) collected from a patient, the method comprising:
extracting, via a microneedle layer, the ISF into a sample collection chamber formed on a biological fluid monitoring system comprising the microneedle layer, a pneumatic layer, and a membrane, wherein the membrane is positioned between the pneumatic layer and the microneedle layer; collecting a test sample of the extracted ISF by moving a portion of the ISF from the sample collection chamber to a metering chamber formed on the biological fluid monitoring system; determining a volume of the test sample; moving the test sample from the metering chamber to a test chamber formed on the biological fluid monitoring system; conducting an electrochemical reaction on the test sample; and moving the test sample to a waste chamber formed on the biological fluid monitoring system to complete the test cycle.

14 . The method of claim 13 , wherein each of the formed chambers is coupled to one another via a microfluidic layer.

15 . The method of claim 13 , wherein the biological fluid monitoring system comprises a plurality of electromagnet assemblies each coupled to one of the formed chambers and configured to move the test sample between the coupled to formed chamber and the adjacent formed chamber.

16 . The method of claim 13 , wherein the test cycle is repeated to provide continuous monitoring of the patient.

17 . The method of claim 13 , wherein the microneedle layer comprises a plurality of microneedles configured to extract the ISF from the patient.

18 . A biological fluid monitoring system configured to be worn by a patient, the system comprising:
a microneedle layer comprising a plurality of microneedles; a pneumatic layer; a membrane, wherein the membrane is positioned between the pneumatic layer and the microneedle layer; a sample collection chamber, a metering chamber, a test chamber, and a waste chamber each formed between the pneumatic layer and the microneedle layer and coupled to each other via a microfluidic layer, wherein the microneedles are configured to extract interstitial fluid (ISF) from the patient into the sample collection chamber; and at least one electromagnet assembly coupled to a respective one of the formed chambers and a valve formed by a valve block, the at least one electromagnet assembly comprising an iron core, a wire, and a permanent magnet, wherein the iron core and the wire form an electromagnet having an opposite polarity to the permanent magnet, wherein the electromagnet is configured to, when charged:
detach from the permanent magnet to allow air into a formed pump source chamber, and
generate a negative pressure in the respective coupled to formed chamber to open the valve,

wherein the electromagnet is configured to, when charged:
close the formed pump sourc

Assignees

• Jiang Hanqing
• Liang Chao
• Univ Arizona State

Inventors

• Jiang Hanqing
• Liang Chao

Classifications

• A61B5/155

  Devices} specially adapted for continuous or multiple sampling, e.g. at predetermined intervals {(devices loaded with multiple lancets simultaneously A61B5/15146) · CPC title

• G01N27/3272

  Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels (optical biosensors G01N33/52) · CPC title

• A61B5/157

  {Devices} characterised by integrated means for measuring characteristics of blood · CPC title

• A61B5/150221

  Valves · CPC title

• A61B2010/008

  Interstitial fluid · CPC title