Blood analyte collection device and methods of use thereof

Patent metadata

Field	Value
Publication number	US-2016166185-A1
Application number	US-201414908725-A
Country	US
Kind code	A1
Filing date	Aug 21, 2014
Priority date	Aug 22, 2013
Publication date	Jun 16, 2016
Grant date	—

Abstract

Provided is a blood analyte collection device that includes a microneedle array configured to provide fluid communication between a cellular interstitial fluid of a subject and a collection device fluid, a device chamber containing the collection device fluid, and a sequestration material in the device chamber configured to bind to a blood analyte from the cellular interstitial fluid. Also provided are methods and kits that use the subject blood analyte collection device. The subject devices, methods and kits find use in a variety of applications, such as detecting a blood analyte, such as glucose, in a subject.

First claim

That which is claimed is:

1 . A blood analyte collection device comprising:
(a) a microneedle array configured to provide fluid communication between a cellular interstitial fluid of a subject and a collection device fluid; (b) a device chamber containing the collection device fluid; and (c) a sequestration material in the device chamber configured to bind to a blood analyte from the cellular interstitial fluid.

2 . The blood analyte collection device of claim 1 , wherein the blood analyte is selected from the group consisting of sodium, potassium, urea, creatinine, glucose, HbA1C, chloride, calcium, ammonia, copper, phosphate, inorganic phosphorus, copper, zinc, magnesium, vitamin A, vitamin B 9 , vitamin B 12 , vitamin C, homocysteine, vitamin E, vitamin D, lead, ethanol, recreational drugs, lactate dehydrogenase, amylase, lipase, angiotensin-converting enzyme, acid phosphatase, eosinophil cationic protein, and a micronutrient, or mixtures thereof.

3 . The blood analyte collection device of claim 1 , wherein the cellular interstitial fluid is present in the epidermis of the subject.

4 . The blood analyte collection device of claim 1 , wherein the microneedle array comprises microneedles having a length less than the thickness of the epidermis of the subject.

5 . The blood analyte collection device of claim 4 , wherein the microneedles have a length 50 μm to 200 μm.

6 . The blood analyte collection device of claim 4 , wherein the microneedles have a length 75 μm to 175 μm.

7 . The blood analyte collection device of claim 4 , wherein the microneedles have a length of 100 μm to 150 μm.

8 . The blood analyte collection device of claim 1 , wherein the sequestration material comprises a glucose binding protein.

9 . The blood analyte collection device of claim 8 , wherein the glucose binding protein is derived from Thermus thermophiles, Pseudomonas aeruginosa, Thermotoga maritime, Agrobacterium radiobacter, Pseudomonas aeruginosa, Lathyrus ochrus , pre-confluent chicken fibroblasts, confluent chicken fibroblasts, or mouse duodenal brush border membrane.

10 . The blood analyte collection device of claim 1 , wherein the sequestration material comprises a glucose binding polymer.

11 . A method for detecting a blood analyte in a subject, the method comprising:
(a) contacting the blood analyte collection device of claim 1 to a skin surface of a subject; (b) removing the blood analyte collection device from the skin surface of the subject; and (c) determining a concentration of the blood analyte.

12 . The method of claim 11 , wherein the determining comprises:
retrieving the bound blood analyte from the blood analyte collection device; and assessing the concentration of the blood analyte.

13 . The method of claim 11 , wherein multiple blood analytes are collected simultaneously.

14 . The method of claim 11 , wherein the blood analyte is selected from the group consisting of sodium, potassium, urea, creatinine, glucose, HbA1C, chloride, calcium, ammonia, copper, phosphate, inorganic phosphorus, copper, zinc, magnesium, vitamin A, vitamin B 9 , vitamin B 12 , vitamin C, homocysteine, vitamin E, vitamin D, lead, ethanol, recreational drugs, lactate dehydrogenase, amylase, lipase, angiotensin-converting enzyme, acid phosphatase, eosinophil cationic protein, and a micronutrient, or mixtures thereof.

15 . The method of claim 11 , further comprising maintaining the blood analyte collection device on the skin surface of the subject for a period of time to collect the blood analyte.

16 . The method of claim 15 , wherein the period of time is 2 hours to 96 hours.

17 . The method of claim 15 , wherein the period of time is 5 hours to 60 hours.

18 . The method of claim 15 , wherein the period of time is 12 hours to 48 hours.

19 . The method of claim 15 , wherein the period of time is 24 hours.

20 . A kit comprising:
analyte collection device of claim 1 ; and a packaging containing the device.

Assignees

• Univ California

Inventors

• Liepmann Dorian
• Paredes Jacobo
• Marriott Gerard

Classifications

• A61B5/14532

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• A61B5/14514 Primary

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

• A61B2010/008

  Interstitial fluid · CPC title

• A61B5/157

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

• A61B5/1468

  using chemical or electrochemical methods, e.g. by polarographic means · CPC title