# US 2019/0167166 A1 · Medical devices having a dynamic surface profile and methods for production and use thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0167166 A1 - Document ID: US20190167166A1 - Status: Published application - Kind: A1 - Application number: 16/205,792 - Filed: 2018-11-30 - Published: 2019-06-06 - Earliest claimed: 2017-12-05 - Assignees: Abbott Diabetes Care Inc. - Applicants: Abbott Diabetes Care Inc. - Inventors: Jonathan McCanless; Hyun Brian Cho; Benjamin Feldman; Frank David Fujimoto - Web page: https://patentgrep.com/patent/US20190167166A1 ## CPC - 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)} - A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement} - A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes} - A61B 5/4839: {combined with drug delivery} - A61B 5/6802: {Sensor mounted on worn items} - A61B 5/6849: {in combination with a needle set} - A61B 5/0002: {Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07)} - A61B 2560/0406: specially shaped apparatus housings - A61B 2562/02: Details of sensors specially adapted for in-vivo measurements - A61B 2562/12: Manufacturing methods specially adapted for producing sensors for in-vivo measurements - A61B 2562/164: the sensor is mounted in or on a conformable substrate or carrier - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## 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 ### Claim 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. ### Claim 2 (depends on 1) The medical device of claim 1, wherein the tissue-facing surface profile comprises a protrusion extending from the base surface. ### Claim 3 (depends on 2) The medical device of claim 2, wherein at least a portion of the protrusion is defined upon an insert positioned in the base surface. ### Claim 4 (depends on 2) 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. ### Claim 5 (depends on 2) The medical device of claim 2, wherein the protrusion comprises a dynamic material that is positioned to contact the tissue. ### Claim 6 (depends on 5) The medical device of claim 5, wherein the protrusion is compositionally homogenous. ### Claim 7 (depends on 2) 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. ### Claim 8 (depends on 2) 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. ### Claim 9 (depends on 8) 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. ### Claim 10 (depends on 1) The medical device of claim 1, wherein at least a portion of the tissue-facing surface profile comprises a dynamic material. ### Claim 11 (depends on 10) 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. ### Claim 12 (depends on 10) The medical device of claim 10, wherein the tissue-facing surface profile is configured to decrease in hardness after contacting the tissue. ### Claim 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. ### Claim 14 (depends on 1) 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. ### Claim 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. ### Claim 16 (depends on 15) The method of claim 15, wherein at least a portion of the tissue-facing surface profile comprises a dynamic material. ### Claim 17 (depends on 16) 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. ### Claim 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. ### Claim 19 (depends on 18) 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. ### Claim 20 (depends on 18) The method of claim 18, wherein at least a portion of the protrusion comprises a dynamic material.