IP Library Granted Patent US 12,414,713
Granted Patent B2
US 12,414,713 · App. 18/423,162 · Granted Sep 16, 2025

Medical devices having a dynamic surface profile and methods for production and use thereof

Inventors: Jonathan McCanless (Oakland, CA); Hyun Brian Cho (Berkeley, CA); Benjamin J. Feldman (Berkeley, CA); Frank David Fujimoto (Fremont, CA)
Assignee: Abbott Diabetes Care Inc.
A61B5/14503A61B5/14532A61B5/14546A61B5/4839A61B5/6802A61B5/6849A61B5/0002A61B2560/0406A61B2562/02A61B2562/12A61B2562/164
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Quick Facts
Patent No.
US 12,414,713
App. No.
18/423,162
Granted
Sep 16, 2025
Kind
B2
Abstract

Medical devices configured for in vivo assays of one or more analytes can sometimes be problematic if left inserted in a tissue, such as skin, for an extended time. Certain medical device surface profiles may aid in alleviating this issue. Accordingly, medical devices may comprise a base surface having a tissue-facing surface profile defined thereon, and a sensor extending through the base surface and at least a portion of the tissue-facing surface profile. The tissue-facing surface profile deviates from the base surface, and the tissue-facing surface profile is also configured to undergo a change in shape, hardness, or a combination thereof after contacting a tissue for a length of time. A dynamic material may be present in at least a portion of the tissue-facing surface profile.

Claims (41)

1. A medical device for monitoring an analyte in a biological fluid, the medical device comprising:

a sensor housing comprising:

a core extending from a base surface of the sensor housing, wherein the core comprises a core material, and

a protrusion disposed on a tip of the core and having a convex surface, wherein the protrusion comprises a dynamic material that is different than the core material; and

an analyte sensor at least partially arranged within the sensor housing, wherein a portion of the analyte sensor extends through the base surface, the core, and the protrusion, wherein the portion of the analyte sensor is configured to be positioned under a skin surface of a user and in contact with the biological fluid,

wherein the protrusion is configured to be placed against the skin surface of the user and comprises a surface profile that is symmetric about a centerline of the protrusion,

wherein the analyte sensor extends along the centerline, and

wherein the dynamic material degrades over a period of time in which the medical device is in use.

2. The medical device of claim 1 , wherein the protrusion is at least partially enclosed within a shell material.

3. The medical device of claim 1 , wherein the dynamic material comprises a material that is degradable by air, water, or light.

4. The medical device of claim 1 , wherein the dynamic material comprises one of cellulose, polyglycolides, or thermoplastic polymers.

5. The medical device of claim 1 , further comprising a drug substance or biologically active material disposed upon or within a tissue-facing surface profile of the sensor housing, the drug substance or biologically active material being releasable from the protrusion upon the protrusion undergoing degradation.

6. The medical device of claim 1 , wherein the analyte sensor is a dermal sensor.

7. The medical device of claim 1 , wherein the protrusion comprises a hemispherical shape.

8. The medical device of claim 1 , wherein the protrusion comprises a planar face, and wherein the analyte sensor extends through the planar face of the protrusion.

9. The medical device of claim 1 , wherein the protrusion is one of a plurality of protrusions of a tissue-facing surface profile of the sensor housing.

10. The medical device of claim 1 , wherein the dynamic material comprises a material that is thermally degradable above physiological temperatures.

11. The medical device of claim 10 , wherein the dynamic material degrades between 37° C. and 50° C., inclusive.

12. The medical device of claim 1 , wherein the analyte sensor is a glucose sensor.

13. The medical device of claim 1 , wherein at least a portion of the surface profile comprises an adhesive configured to promote adhesion to the skin surface.

14. A method, comprising:

monitoring analyte levels in a bodily fluid by a medical device, wherein the medical device comprises:

a base surface,

a core extending from the base surface, wherein the core comprises a core material,

a protrusion disposed on a tip of the core and having a convex surface, wherein the protrusion comprises a dynamic material different than the core material, and

an analyte sensor extending through the base surface, the core, and the protrusion;

positioning the base surface against a skin surface of a user;

positioning a portion of the analyte sensor under the skin surface and in contact with the bodily fluid; and

degrading the dynamic material over a period of time in which the medical device is in use.

15. The method of claim 14 , wherein monitoring analyte levels comprises monitoring glucose levels, and wherein the analyte sensor is a glucose sensor.

16. The method of claim 15 , wherein the analyte sensor is inserted at a depth below the skin surface, wherein degrading the dynamic material causes the depth at which the analyte sensor is arranged below the skin surface to increase.

17. A medical device for monitoring an analyte, the medical device comprising:

a sensor housing comprising:

a base surface,

a core extending from the base surface,

a protrusion disposed on a tip of the core and having a convex surface, wherein the protrusion comprises a dynamic material and comprises a surface profile that is symmetric about a centerline of the protrusion; and

an analyte sensor at least partially arranged within the sensor housing, wherein a portion of the analyte sensor extends through the base surface and the protrusion, wherein the portion of the analyte sensor is configured to be positioned under a skin surface of a user and in contact with a biological fluid of the user, wherein the analyte sensor extends along the centerline and through a channel formed in the core and the protrusion, and

wherein the dynamic material dissolves over a period of time in which the medical device is in use.

18. The medical device of claim 17 , wherein a rate of dissolution of the dynamic material changes when the dynamic material is exposed to an aqueous environment.

19. The medical device of claim 17 , wherein the dynamic material comprises at least one of organic salts, inorganic salts, compressed powder, dehydrated borates, and polyhydroxylated compounds.

20. The medical device of claim 17 , wherein the analyte sensor is a glucose sensor.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 29, 2024
From: MCCANLESS, JONATHAN; CHO, HYUN BRIAN; FELDMAN, BENJAMIN J.; FUJIMOTO, FRANK DAVID
To: ABBOTT DIABETES CARE INC.
Reel/Frame 066607/0487 →
Continuity (3)
Continuation 16205792 · Nov 30, 2018
Provisional Application 62594700 · Dec 5, 2017
Related Publication 20240156371A1 · May 16, 2024
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