Microneedle arrays for biosensing and drug delivery

• US 10,136,846 B2
• Filed: 08/25/2017
• Issued: 11/27/2018
• Est. Priority Date: 09/02/2011
• Status: Active Grant

• Current Assignee: National Technology & Engineering Solutions Of Sandia LLC (Honeywell International Inc.), Regents of the University of California (University of California), North Carolina State University (University of North Carolina System)
• Original Assignee: National Technology & Engineering Solutions Of Sandia LLC (Honeywell International Inc.), Regents of the University of California (University of California), North Carolina State University (University of North Carolina System)
• Inventors: Wang, Joseph, Windmiller, Joshua Ray, Narayan, Roger, Miller, Phillip, Polsky, Ronen, Edwards, Thayne L.
• Primary Examiner(s): WEARE, MEREDITH H
• Application Number:
  US15/687,145
• Publication Number:
  US 20170347925A1
• Time in Patent Office: 459 Days
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 2562/046 in a matrix array
• 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 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/276 Protection against electrode failure
• CPC Class Codes: A61B 5/4845 Toxicology, e.g. by detection of alcohol, drug or toxic products A61B5/4848 takes precedence
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61B 5/685 Microneedles
• 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 2005/1726 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 2037/003 having a lumen
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G01N 33/48785 : Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply

Abstract

Methods, structures, and systems are disclosed for biosensing and drug delivery techniques. In one aspect, a device for detecting an analyte and/or releasing a biochemical into a biological fluid can include an array of hollowed needles, in which each needle includes a protruded needle structure including an exterior wall forming a hollow interior and an opening at a terminal end of the protruded needle structure that exposes the hollow interior, and a probe inside the exterior wall to interact with one or more chemical or biological substances that come in contact with the probe via the opening to produce a probe sensing signal, and an array of wires that are coupled to probes of the array of hollowed needles, respectively, each wire being electrically conductive to transmit the probe sensing signal produced by a respective probe.

Claims

1. An analyte-selective sensor device, comprising:

a substrate that includes at least one microneedle with a hollowed interior, wherein the at least one microneedle comprises an interior wall with an opening to the hollowed interior;

an electrode comprising a probe, wherein the probe is disposed inside the hollowed interior and spaced away from the interior wall, wherein the electrode is functionalized by a coating comprising an enzyme-functionalized coating or an ion-selective coating over at least the probe to interact with an analyte to produce an electrical signal; and

a wire electrically coupled to the probe operable to transfer the electrical signal.

2. The device of claim 1, wherein the device is integrated into an adhesive patch for placement on skin to detect the analyte residing in transdermal fluid.

3. The device of claim 1, wherein the probe includes at least one of a carbon fiber, carbon paste, conducting metal, or the conducting polymer.

4. The device of claim 1, wherein the analyte includes at least one of a biochemical, metabolite, electrolyte, ion, pathogen, or microorganism.

5. The device of claim 1, wherein the device is operable to detect an electrochemical interaction between the analyte and the enzyme-functionalized coating or the ion-selective coating using at least one of amperometry, voltammetry, or potentiometry.

6. The device of claim 1, further comprising a processing unit in communication with the wire that receives the electrical signal and uses the electrical signal as data.

7. The device of claim 6, wherein the processing unit is operable to compare the data to a threshold value to determine whether a concentration of the analyte reflects a healthy state or a disease state.

8. The device of claim 6, wherein the processing unit is operable to determine a pattern in the data that indicates whether a concentration of the analyte reflects a healthy state or a disease state.