SYSTEMS AND METHODS FOR SECURING A CONTINUOUS ANALYTE SENSOR TO A HOST

• US 20160058380A1
• Filed: 08/25/2015
• Published: 03/03/2016
• Est. Priority Date: 08/26/2014
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Bowman, Leif N., Hughes, Jonathan, Jackson, Jeff, Lieu, Phong, Pal, Andrew Attila, Petisce, James R., Pryor, Jack, Simpson, Peter C., Wightlin, Matthew D., Lee, James Jinwoo, Gackstetter, Tim Ray, Lee, Ted Tang, Schneider, Roger, Vigil, George
• Granted Patent: US 11,219,413 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6832 using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/68335 including release sheets or liners
• CPC Class Codes: A61B 5/6849 in combination with a needle set

Abstract

Adhesive pad systems that provide longer lasting adherence of the mounting unit to the host'"'"'s skin are provided. Some systems include a reinforcing overlay that at least partially covers the adhesive pad. The reinforcing overlay may be removable without disturbing the sensor so that the overlay may be replaceable.

Claims

1. An adhesive pad system for securing a continuous analyte sensor assembly to skin of a host, the system comprising:

a housing configured to receive a sensor electronics unit;

an adhesive layer configured to adhere to a host'"'"'s skin, the adhesive layer having an upper surface and an undersurface, wherein the undersurface of the adhesive layer includes an adhesive material configured to adhere the adhesive layer to the skin of the host; and

a cushioning layer configured to adhere to the adhesive layer, the cushioning layer having an upper surface and an undersurface, wherein the undersurface of the cushioning layer includes an adhesive material configured to adhere the cushioning layer to the upper surface of the adhesive layer, the cushioning layer further having a first thickness.

2. The system of claim 1, wherein the adhesive layer has a second thickness that is less than the first thickness, wherein the adhesive layer has a larger perimeter dimension than the cushioning layer, such that the adhesive layer extends outwardly on all sides from a periphery of the cushioning layer when the cushioning layer is positioned over the adhesive layer.

3. The system of claim 1, further comprising a layer of double-sided tape configured to be interposed between the adhesive layer and the sensor electronics unit housing.

4. The system of claim 3, wherein the double-sided tape has a smaller perimeter dimension than both the overlay and the cushioning layer.

5. The system of claim 1, wherein the upper surface of the cushioning layer abuts and adheres to a bottom surface of the electronics unit housing.

6. The system of claim 1, wherein the housing comprises a planar bottom wall and a lip that extends around a periphery of the bottom wall.

7. The system of claim 6, wherein the bottom wall includes an opening to accommodate a sensor of the sensor assembly.

8. The system of claim 7, wherein the cushioning layer, and the adhesive layer, each include at least one opening, and the openings in the cushioning layer and the adhesive layer align with one another and with the opening in the bottom wall of the housing.

9. An adhesive pad system for securing a continuous analyte sensor assembly to skin of a host, the system comprising:

a housing configured to receive a sensor electronics unit;

an adhesive pad having an upper surface and an undersurface, wherein the housing is secured to the upper surface of the adhesive pad, and wherein the undersurface of the adhesive pad includes an adhesive material configured to adhere the adhesive pad to the skin of the host; and

an adhesive layer having an upper surface, an undersurface, and a central opening configured to allow at least a portion of the housing to protrude therefrom, wherein the undersurface of the overlay includes an adhesive material configured to adhere the overlay to the adhesive pad and to the skin of the host, wherein the overlay has a larger perimeter dimension than the adhesive pad, such that the overlay extends outwardly on all sides from a periphery of the adhesive pad when the overlay is positioned over the adhesive pad with the housing protruding through the central opening, and wherein a first portion of the overlay adheres to the adhesive pad and a second portion of the overlay adheres to the skin of the host.

10. The system of claim 9, wherein the first portion of the overlay comprises from about 10% to about 65% of a total area of the overlay.

11. The system of claim 10, wherein the first portion of the overlay comprises from about 20% to about 55% of the total area of the overlay.

12. The system of claim 9, wherein the adhesive pad has an area from about 1 square inch to about 2 square inches.

13. The system of claim 12, wherein the overlay has an area from about 4 square inches to about 7 square inches.

14. The system of claim 9, wherein the ultimate adhesive strength of the adhesive pad system immediately after application to a test surface is great than about 12 lbf.

15. The system of claim 14, wherein the test surface is stainless steel.

16. The system of claim 9, wherein application of the overlay onto the adhesive pad results in an increased adhesive strength that is from about 40% to about 45% of the adhesive strength of the adhesive pad alone.

17. The system of claim 9, wherein the overlay is configured to be removed from the adhesive pad and from the skin of the host without disturbing continued operation of the sensor electronics unit.

18. A method for securing a continuous analyte sensor assembly to skin of a host, the method comprising:

securing the continuous analyte sensor assembly to the skin of the host, wherein the continuous analyte sensor assembly comprises a continuous analyte sensor, an adhesive pad, and a housing configured to receive a sensor electronics unit, wherein the adhesive pad comprises an upper surface and an undersurface, wherein the housing is secured to the upper surface of the adhesive pad, and wherein the undersurface of the adhesive pad includes an adhesive material configured to adhere the adhesive pad to the skin of the host; and

applying a reinforcing overlay to the adhesive pad and to the skin, wherein the overlay comprises a top surface and a bottom surface, wherein the overlay includes an upper surface, an undersurface, and a central opening configured to allow at least a portion of the housing to protrude therefrom, wherein the undersurface of the overlay includes an adhesive material configured to adhere the overlay to the adhesive pad and to the skin of the host, wherein the overlay has a larger perimeter dimension than the adhesive pad, such that the overlay extends outwardly on all sides from a periphery of the adhesive pad when the overlay is positioned over the adhesive pad with the housing protruding through the central opening, and wherein a first portion of the overlay adheres to the adhesive pad and a second portion of the overlay adheres to the skin of the host.

19. The method of claim 18, wherein the first portion of the overlay comprises from about 10% to about 65% of a total area of the overlay.

20. The method of claim 19, wherein the first portion of the overlay comprises from about 20% to about 55% of a total area of the overlay.

21. The method of claim 18, wherein the adhesive pad has an area from about 1 square inch to about 2 square inches.

22. The method of claim 21, wherein the overlay has an area from about 4 square inches to about 7 square inches.