Systems and methods for continuous health monitoring using an opto-enzymatic analyte sensor

• US 10,695,000 B2
• Filed: 09/01/2016
• Issued: 06/30/2020
• Est. Priority Date: 09/02/2015
• Status: Active Grant

• Current Assignee: Metronom Health Inc.
• Original Assignee: Metronom Health Inc.
• Inventors: Bremer, Troy M.
• Primary Examiner(s): Winakur, Eric F
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US15/254,995
• Publication Number:
  US 20170055906A1
• Time in Patent Office: 1,398 Days
• Field of Search: None
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• CPC Class Codes: A61B 2562/0238 Optical sensor arrangements for performing transmission measurements on body tissue
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 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 5/6833 Adhesive patches
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: C09J 2301/18 characterized by perforations in the adhesive tape
• CPC Class Codes: C09J 2301/312 parameters being the characterizing feature
• CPC Class Codes: C09J 7/29 Laminated material metallised plastics C09J7/22
• CPC Class Codes: Y10T 428/28 Web or sheet containing structurally defined element or component and having an adhesive outermost layer
• CPC Class Codes: Y10T 428/2848 Three or more layers

Abstract

Certain embodiments described herein pertain to optical sensors, systems and methods for continuous glucose monitoring. In some embodiments, methods of preparing a layered optical sensor are disclosed. The optical sensor can be formed by laminating a plurality of sheets together to form a final sensor. In some embodiments, the sensor tip comprises a oxygen conduit, an enzymatic layer, and an sensing layer. In some embodiments, the sensor includes a plurality of waveguides configured to direct light to and from a target material, such as an oxygen sensing polymer. Systems are also disclosed for an adhesive system for attaching an optical sensor-transmitter system. Methods and systems are also disclosed for a sensor inserter system. The inserter can include a lancet tip that includes a convex feature attached to a first surface of the lancet tip.

Claims

1. A layered optical sensor comprising:

a sensing layer including at least one waveguide having an exposed waveguide core;

an oxygen sensing polymer region at least partially extending into the sensing layer and in direct communication with the exposed waveguide core, the oxygen sensing polymer region comprising an oxygen sensing polymer that contacts the exposed waveguide core;

an enzymatic reaction layer disposed on top of the sensing layer; and

an enzymatic hydrogel reaction region formed in the enzymatic reaction layer, the enzymatic hydrogel reaction region at least partially defined by the enzymatic reaction layer and the oxygen sensing polymer, the enzymatic hydrogel reaction region comprising an enzymatic hydrogel.

2. The layered optical sensor of claim 1, further comprising an oxygen permeable polymer layer disposed on top of the enzymatic reaction layer.

3. The layered optical sensor of claim 2, further comprising an oxygen transport layer disposed on top of the oxygen permeable polymer layer.

4. The layered optical sensor of claim 3, further comprising a capping layer disposed on top of the oxygen transport layer.

5. The layered optical sensor of claim 1, wherein at least a first surface of the oxygen sensing polymer that partially defines the enzymatic hydrogel reaction region includes a surface modification that ensures that the oxygen sensing polymer and the enzymatic hydrogel are in physical contact with each other.

6. The layered optical sensor of claim 5, wherein the surface modification is laser ablated or embossed.