In vivo glucose sensing in an increased perfusion dermal layer

• US 9,668,686 B2
• Filed: 02/05/2014
• Issued: 06/06/2017
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Feldman, Benjamin Jay, Cho, Hyun, Leach, Austin, Mazza, John Charles
• Primary Examiner(s): WESTON, TIFFANY C
• Application Number:
  US14/173,619
• Publication Number:
  US 20140275907A1
• Time in Patent Office: 1,217 Days
• Field of Search: 600345, 600347, 600365
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1491 Heated applicators

Abstract

Systems, devices, and methods are provided that enable the sensing of an analyte level within, e.g., the dermal layer of the skin of a subject. These systems, devices, and methods can utilize modalities that increase perfusion in an area local to a dermal sensor.

Claims

1. An apparatus, comprising:

a sensor insertable into a dermal layer of skin of a subject and adapted to sense an analyte level in the dermal layer;

a base from which the sensor extends, the base being adapted to contact the skin of the subject with the sensor inserted into the dermal layer;

an insertion needle; and

a perfusion modulator adapted to increase perfusion in the dermal layer, wherein the perfusion modulator is at least one protrusion located on the base,

wherein the at least one protrusion is adapted to apply pressure to increase perfusion in an area local to the sensor when inserted into the dermal layer, and

wherein the insertion needle extends from the first protrusion adjacent to the sensor.

2. The apparatus of claim 1, wherein the at least one protrusion has a cross-sectional profile, the shape of the cross-sectional profile having a convex distal portion and concave proximal portions on both sides of the distal portion.

3. The apparatus of claim 1, wherein the at least one protrusion has a cross-sectional profile, the shape of the cross-sectional profile being substantially that of a bell-curve.

4. The apparatus of claim 3, further comprising a plurality of secondary protrusions.

5. The apparatus of claim 3, wherein the sensor extends from a distal termination of the at least one protrusion.

6. The apparatus of claim 1, wherein the insertion needle has an angled tip portion that extends over a distal termination of the sensor and is adapted to create an insertion path for the sensor.

7. The apparatus of claim 1, wherein the insertion needle does not have an interior space and has a pointed, non-bladed distal termination.

8. The apparatus of claim 1, wherein the at least one protrusion comprises a hemispherical proximal portion and a cylindrical distal portion.

9. The apparatus of claim 1, wherein the at least one protrusion comprises a first protrusion having a hemispherical portion and a plurality of secondary protrusions.

10. The apparatus of claim 9, wherein the plurality of secondary protrusions are arranged radially about and spaced apart from the hemispherical portion of the first protrusion.

11. The apparatus of claim 1 wherein the at least one protrusion comprises a first protrusion having a cylindrical distal portion and a gradually sloping proximal portion that is located between the base and the cylindrical distal portion.

12. The apparatus of claim 11, wherein the cylindrical distal portion defines a cavity that surrounds an opening from which the sensor extends.

13. The apparatus of claim 1, further comprising electrical circuitry adapted to control the sensor.

14. The apparatus of claim 13, further comprising:

a power supply; and

a housing that houses the electrical circuitry and the power supply.

15. The apparatus of claim 1, further comprising communication hardware for communicating data to a reader device.

16. The apparatus of claim 1, wherein the sensor comprises a sensing portion that is positioned to extend between 0.5 and 3.0 mm into the skin.

17. The apparatus of claim 1, wherein the analyte is glucose.

18. The apparatus of claim 1, further comprising:

a processor adapted to control the sensor, wherein the sensor is adapted to sense a glucose level in the dermal layer;

RFID circuitry adapted to wirelessly communicate data indicative of a sensed glucose level to a reader device;

a power supply; and

a housing that houses the processor, the RFID circuitry, and the power supply.

19. The apparatus of claim 1, further comprising:

a processor adapted to control the sensor, wherein the sensor is adapted to sense a glucose level in the dermal layer;

Bluetooth circuitry adapted to wirelessly communicate data indicative of a sensed glucose level to a reader device;

a power supply; and

a housing that houses the processor, the Bluetooth circuitry, and the power supply.