Diagnostic/drug delivery “sense-respond” devices, systems, and uses thereof

• US 9,987,427 B1
• Filed: 06/22/2015
• Issued: 06/05/2018
• Est. Priority Date: 06/24/2014
• Status: Active Grant

• Current Assignee: National Technology & Engineering Solutions Of Sandia LLC (Honeywell International Inc.)
• Original Assignee: National Technology & Engineering Solutions Of Sandia LLC (Honeywell International Inc.)
• Inventors: Polsky, Ronen, Miller, Philip Rocco, Edwards, Thayne L.
• Primary Examiner(s): Vu, Quynh-Nhu H
• Application Number:
  US14/746,301
• Time in Patent Office: 1,079 Days
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 2202/048 Anaesthetics see also A61M19/00
• CPC Class Codes: A61M 2202/30 Vaccines
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

The present invention is directed to devices, systems, and methods for detecting and/or monitoring one or more markers in a sample. In particular, such devices integrate a plurality of hollow needles configured to extract or obtain a fluid sample from a subject, as well as transducers to detect a marker of interest.

Claims

1. A device for detecting one or more markers in a sample from a target site of a subject, the device comprising:

(i) a sensor component comprising at least one first hollow needle and at least one first sensing transducer in fluidic communication with the at least one first hollow needle, wherein the at least one first sensing transducer is configured to detect one or more markers in the sample;

(ii) a delivery component comprising one or more depots configured to contain one or more therapeutic agents;

(iii) a return needle configured to return fluid to the target site of the subject;

(iv) an electronic component comprising circuitry configured for signal processing, signal control, power control, and/or communication signaling, wherein the electronic component is connected electrically to the sensor and delivery components.

2. The device of claim 1, wherein (i) the sensor component comprises:

a plurality of hollow needles, wherein each needle has an interior surface facing the hollow lumen and an exterior surface, the distal end of the exterior surface for at least one needle comprises a puncturing edge, and at least one needle has a length of more than about 0.5 mm;

a substrate coupled to the plurality of hollow needles, wherein the substrate comprises one or more inlets in fluidic communication with the proximal end of at least one needle; and

a first channel disposed within the substrate and in fluidic communication with at least one inlet of the substrate; and

wherein the at least one first sensing transducer is in fluidic communication with the first channel.

3. The device of claim 1, wherein (ii) the delivery component further comprises:

a plurality of second hollow needles, wherein each second hollow needle has an interior surface facing the hollow lumen and an exterior surface, the distal end of the exterior surface for at least one second hollow needle comprises a puncturing edge, and at least one second hollow needle has a length of more than about 0.5 mm; and

wherein at least one second hollow needle is in fluidic communication with at least one depot.

4. The device of claim 3, further comprising one or more pumps and/or valves in fluidic communication with the one or more depots.

5. The device of claim 1, wherein (iv) the electronic component comprises a battery, a pump fluidically connected to at least one first hollow needle of the sensor component, and an electrical connection to one or more indicators.

6. The device of claim 1, further comprising (v) a fluidic component comprising one or more fluidic channels, chambers, pumps, and/or valves configured to provide fluidic communication between the sensor or delivery component and the sample.

7. The device of claim 2, wherein the substrate comprises a further inlet in fluidic communication with a proximal end of the return needle.

8. The device of claim 7, further comprising a pump in fluidic communication with the further inlet of the substrate.

9. The device of claim 1, wherein the at least one first hollow needle is configured to obtain the sample from a subject.

10. The device of claim 9, wherein a puncturing edge of the first hollow needle comprises a tapered point, a sharpened bevel, or one or more prongs.

11. The device of claim 1, wherein the at least one first hollow needle comprises a polymer, a metal, silicon, glass, a composite material, or a combination thereof.

12. The device of claim 1, wherein the at least one first sensing transducer is selected from the group consisting of an electrode, an ion selective electrode, an optical sensor, an array of any of these, and combinations thereof.

13. The device of claim 12, wherein the at least one first sensing transducer further comprises a modified surface.

14. The device of claim 12, wherein at least one first sensing transducer is an electrode selected from the group of a planar electrode, a three-dimensional electrode, a porous electrode, a microelectrode, and a nanoelectrode, or an array thereof.

15. The device of claim 1, wherein the sensor component, delivery component, the return needle, and electronic component are configured into an integrated structure.

16. The device of claim 1, wherein the sensor component, delivery component, and electronic component are configured into separate modules.

17. The device of claim 1, wherein the at least one first hollow needle is configured to obtain an interstitial fluid in vivo.

18. A kit comprising:

(i) a device of claim 1; and

(ii) a therapeutic agent configured to be injected into the depot.

19. The kit of claim 18, wherein the agent is selected from the group consisting of an anesthetic, an antiseptic, an anticoagulant, a drug, and a vaccine.

20. A method of monitoring one or more markers from a target site of a subject, the method comprising:

(i) affixing the device of claim 1 on the target site of the subject;

(ii) activating the device, thereby monitoring one or more markers in the target site; and

(iii) returning fluid to the target site of the subject by employing the return needle.

21. The method of claim 20, further comprising (iv) delivering one or more therapeutic agents to the subject.

22. The method of claim 20, wherein the sample is interstitial fluid, blood, plasma, serum, transdermal fluid, sweat, or a bodily fluid.