Medical devices having a dynamic surface profile and methods for production and use thereof
Inventors
McCanless, Jonathan • Cho, Hyun Brian • Feldman, Benjamin J. • Fujimoto, Frank David
Assignees
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Publication Number
US-12414713-B2
Publication Date
2025-09-16
Expiration 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.
Core Innovation
The invention relates to in vivo analyte monitoring using a medical device that includes a sensor housing with a base surface, a core extending from the base surface, and a protrusion disposed on a tip of the core with a convex surface. The protrusion comprises a dynamic material different than the core material, and the protrusion has a surface profile symmetric about a centerline of the protrusion. An analyte sensor is at least partially arranged within the sensor housing, with a portion extending through the base surface, the core, and the protrusion, such that the portion is positioned under a skin surface and in contact with a biological fluid.
The dynamic material is configured to degrade over a period of time in which the medical device is in use, including dynamic material that dissolves over time. The tissue-contacting surface profile dynamically changes shape and/or hardness over time after tissue contact, including flattening of the surface profile, and provides initial rigidity for insertion/localization followed by softening and flattening for comfort and deeper, more secure implantation while the device remains in use.
The document further describes dynamic material classes and configurations, including gel-forming materials, dissolvable salts or powders, thermally deformable or degradable materials, chemically deformable or degradable materials, hygroscopic, suspension-forming, viscoelastic, and thermoplastic elastomers, layered configurations, and designs where dynamic material is exterior to or enclosed within a shell. Representative protrusion geometries include hemispherical, Gaussian-like, multiple protrusions, and ring-shaped profiles, and the analyte sensor can extend along the centerline and through a channel formed in the core and the protrusion.
Claims Coverage
The partial content provides three independent claims. Across the independent claims, the main inventive features are a sensor housing with a core and a tip protrusion having a convex, centerline-symmetric profile; an analyte sensor portion configured to be positioned under a user’s skin and in contact with a biological fluid through the protrusion; and a dynamic material different from the core that changes over time during use by degrading or dissolving.
Dynamic-material protrusion for skin-contact interface
A sensor housing comprising a core extending from a base surface, 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.
Centerline-symmetric convex protrusion with aligned sensor
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.
In-contact analyte sensor portion through base, core, and protrusion
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.
Dynamic material degrades over period of use
The dynamic material degrades over a period of time in which the medical device is in use.
Positioning and monitoring with dynamic-material degradation
Monitoring analyte levels in a bodily fluid by a medical device 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 with 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.
Dissolving dynamic material in centerline-symmetric protrusion with channel
A sensor housing comprising a base surface, a core extending from the base surface, and a protrusion disposed on a tip of the core 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; 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.
Across the independent claims, the document centers on a skin-contacting protrusion on a sensor housing that uses a dynamic material different from the core material, with an analyte sensor portion configured to extend through the base, core, and protrusion for in-contact placement under a skin surface. The dynamic material is required to degrade or dissolve over time during device use, while the protrusion surface profile is described as symmetric about a centerline and the sensor extends along that centerline.
Stated Advantages
Provides initial rigidity for insertion/localization followed by softening/flattening for comfort and deeper, more secure implantation.
Documented Applications
In vivo analyte monitoring in a biological fluid using a dermal or skin sensor for glucose monitoring.
Monitoring glucose levels using an analyte sensor portion positioned under a skin surface and contacting a biological fluid through a protrusion.
A device interface described as changing tissue-contact surface profile after tissue contact, including flattening of the surface profile over time, supported by an example using hydroxypropylmethylcellulose and an in vitro glucose response.
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