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Publication Number
US-12310727-B2
Publication Date
2025-05-27
Expiration Date
Abstract
A sensor assembly is disclosed. The sensor assembly includes a piercing member with an interior and exterior. Also included within the sensor assembly is a sensor that is formed on a flexible substrate. The sensor includes a proximal end and a distal end where the distal end includes a flex that is terminated at a terminal end. The terminal end of the sensor being located within the interior of the piercing member.
Core Innovation
The invention relates to an in vivo sensor assembly that includes a piercing member having an interior and an exterior, and a sensor having a proximal end and a distal end separated by a sensor straight. The distal end includes a flex terminated at a terminal end, with the terminal end positioned within the interior of the piercing member, so that the sensor straight is adjacent to the exterior of the piercing member and shallow subdermal placement is enabled relative to the depth associated with the piercing member interior.
The distal flex is a multi-layer flexible flex that includes a first layer composed of an insulator, a second layer composed of an electrical conductor disposed between the first and third layers, and an additional third layer. The electrical-conductor second layer has a first width, an intermediate second width located intermediate of the first and third widths, and a third width, with the second width value less than the first width value and the third width having the first width value.
Placement is achieved by positioning the flex within a piercing bevel while the terminal end is maintained within the piercing member interior, and then retracting the piercing member to decouple the terminal end from within the piercing bevel. The assembly further includes a mechanical tuning of the distal flex such that it resists insertion shear yet deforms to avoid breakage during removal, and an ejector can be provided to dislodge the terminal end from within the piercing member or from an optional cannula in a combined sensor and infusion set.
Claims Coverage
The provided claims include three independent claims: a sensor assembly, a method of inserting a sensor into a subdermal space, and a sensor. Each independent claim is anchored on a flex having a three-layer structure with an insulator first layer and an electrical-conductor second layer disposed between the first and third layers, together with a width relationship in which the second width value is less than the first width value.
Piercing-member interior terminal placement with sensor straight adjacent exterior
A sensor assembly comprising a piercing member having an interior and exterior, and a sensor with a distal end including a flex terminated at a terminal end located within the piercing-member interior, where the sensor straight is adjacent the piercing-member exterior.
Three-layer flex with insulator first layer and conductor second layer
The flex includes a first layer composed of an insulator, a second layer disposed between the first and third layers, and a second layer composed of an electrical conductor.
Conductor layer width pattern with intermediate reduced second width
The electrical-conductor second layer has a first width, a second width intermediate of the first and third widths, and a third width where the first width has a first width value, the third width has a first width value, and the second width has a second width value less than the first width value.
Subdermal-space insertion by coupled terminal placement in piercing bevel and retraction decoupling
A method of inserting a sensor into a subdermal space by coupling the sensor to a piercing member where the flex enables placement of the terminal end within a piercing bevel, inserting the piercing member to a depth within the subdermal space with the sensor coupled being inserted to the same depth, and retracting the piercing member such that retraction decouples the terminal end from within the piercing bevel.
Sensor with distal flex terminated at terminal end using three-layer insulator/conductor structure
A sensor including a sensor body with proximal and distal ends separated by the sensor body, where the distal end includes a flex terminated at a terminal end and the flex includes a first layer composed of an insulator and a second layer disposed between the first and third layers, the second layer composed of an electrical conductor.
Sensor flex conductor width relationship with reduced intermediate second width
The electrical-conductor second layer has a first width, a second width, and a third width where the first width has a first width value, the third width has the first width value, the second width is located intermediate of the first and third widths, and the second width has a second width value less than the first width value.
Across the independent claims, the inventive coverage centers on an in vivo sensor assembly and a method/sensor that use a distal flex terminated at a terminal end positioned relative to a piercing bevel and piercing-member interior/exterior, combined with a three-layer flex structure and a defined conductor width relationship in which the intermediate second width is reduced relative to the first and third width.
Stated Advantages
Improving insertion force and comfort.
Documented Applications
An in vivo analyte sensor assembly for placement in a subdermal space.
A combined sensor and infusion set using a piercing member with an optional cannula including perforations for infusate diffusion.
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