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

Patent metadata

Field	Value
Publication number	US-2019167166-A1
Application number	US-201816205792-A
Country	US
Kind code	A1
Filing date	Nov 30, 2018
Priority date	Dec 5, 2017
Publication date	Jun 6, 2019
Grant date	—

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.

First claim

What is claimed is the following:

1 . A medical device for assaying an analyte, the medical device comprising:
a base surface having a tissue-facing surface profile defined thereon, the tissue-facing surface profile deviating from the base surface; and a sensor extending through the base surface and at least a portion of the tissue-facing surface profile;
wherein the tissue-facing surface profile is configured to undergo a change in shape, hardness, or a combination thereof after contacting a tissue for a length of time.

2 . The medical device of claim 1 , wherein the tissue-facing surface profile comprises a protrusion extending from the base surface.

3 . The medical device of claim 2 , wherein at least a portion of the protrusion is defined upon an insert positioned in the base surface.

4 . The medical device of claim 2 , wherein the protrusion comprises a dynamic material in an exterior layer upon a core material, the dynamic material being positioned to contact the tissue.

5 . The medical device of claim 2 , wherein the protrusion comprises a dynamic material that is positioned to contact the tissue.

6 . The medical device of claim 5 , wherein the protrusion is compositionally homogenous.

7 . The medical device of claim 2 , wherein the protrusion comprises a dynamic material at least partially enclosed within a shell material, the shell material being pliable and positioned to contact the tissue.

8 . The medical device of claim 2 , wherein at least a portion of the protrusion comprises a dynamic material, the dynamic material being positioned to contact the tissue.

9 . The medical device of claim 8 , wherein the dynamic material comprises at least one substance selected from the group consisting of a gel-forming material; a dissolvable material; a material that is thermally deformable or thermally degradable at or near physiological temperatures; a material that is thermally deformable or thermally degradable above physiological temperatures; a material that is chemically deformable or chemically degradable by air, water or light; a hygroscopic material; a suspension-forming material; an elastically deformable material; an inelastically deformable material; a viscoelastic deformable material; a thermoplastic elastomer; and any combination thereof.

10 . The medical device of claim 1 , wherein at least a portion of the tissue-facing surface profile comprises a dynamic material.

11 . The medical device of claim 10 , wherein the dynamic material comprises at least one substance selected from the group consisting of a gel-forming material; a dissolvable material; a material that is thermally deformable or thermally degradable at or near physiological temperatures; a material that is thermally deformable or thermally degradable above physiological temperatures; a material that is chemically deformable or chemically degradable by air, water or light; a hygroscopic material; a suspension-forming material; an elastically deformable material; an inelastically deformable material; a viscoelastic deformable material; a thermoplastic elastomer; and any combination thereof.

12 . The medical device of claim 10 , wherein the tissue-facing surface profile is configured to decrease in hardness after contacting the tissue.

13 . The medical device 1 , further comprising:
a drug substance or biologically active material disposed upon or within the tissue-facing surface profile, the drug substance or biologically active material being releasable from the tissue-facing surface profile upon the tissue-facing surface profile undergoing the change in shape, hardness, or combination thereof.

14 . The medical device of claim 1 , wherein the sensor is a dermal sensor and the tissue is a skin surface, the medical device further comprising:
an introducer extending from the base surface in proximity to the dermal sensor.

15 . A method comprising:
forming a tissue-facing surface profile upon a base surface, the tissue-facing surface profile deviating from the base surface and being configured to undergo a change in shape, hardness, or a combination thereof after contacting a tissue for a length of time; and extending a sensor through the base surface and at least a portion of the tissue-facing surface profile.

16 . The method of claim 15 , wherein at least a portion of the tissue-facing surface profile comprises a dynamic material.

17 . The method of claim 16 , wherein forming the tissue-facing surface profile comprises defining a protrusion upon an insert, and positioning the insert upon the base surface, at least a portion of the protrusion comprising the dynamic material.

18 . A method comprising:
providing a medical device comprising a base surface having a tissue-facing surface profile defined thereon, and a dermal sensor extending through the base surface and at least a portion of the tissue-facing surface profile, the tissue-facing surface profile comprising a protrusion extending from the base surface; and positioning the tissue-facing surface profile against a skin surface such that the dermal sensor becomes inserted at a first depth in a dermal layer below the skin surface;
wherein at least one of a change in shape or a change in hardness occurs after contacting the tissue-facing surface profile against the skin surface.

19 . The method of claim 18 , wherein the dermal sensor becomes inserted at a second depth in the dermal layer after at least one of the change in shape or the change in hardness occurs.

20 . The method of claim 18 , wherein at least a portion of the protrusion comprises a dynamic material.

Assignees

• Abbott Diabetes Care Inc

Inventors

• Mccanless Jonathan
• Cho Hyun Brian
• Feldman Benjamin
• Fujimoto Frank David

Classifications

• A61B5/14532

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• A61B2562/164

  the sensor is mounted in or on a conformable substrate or carrier · CPC title

• A61B5/4839

  combined with drug delivery · CPC title

• A61B5/14503 Primary

  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 title

• A61B5/6849

  in combination with a needle set · CPC title