# US 2026/0076594 A1 · Systems, devices, and methods related to ketone sensors > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2026/0076594 A1 - Document ID: US20260076594A1 - Status: Published application - Kind: A1 - Application number: 19/396,918 - Filed: 2025-11-21 - Published: 2026-03-19 - Earliest claimed: 2021-01-26 - Assignees: Abbott Diabetes Care Inc. - Applicants: Abbott Diabetes Care Inc. - Inventors: Shridhara A. Karinka; Stephen Oja - Web page: https://patentgrep.com/patent/US20260076594A1 ## CPC - A61B 5/145: Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value {; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue} (non-radiation detecting or locating of foreign bodies in blood A61B5/06) - A61B 5/14865: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors} - A61B 5/1451: {for interstitial fluid} - A61B 5/1468: using chemical or electrochemical methods, e.g. by polarographic means - A61B 5/1473: invasive, e.g. introduced into the body by a catheter - A61B 5/265: containing silver or silver chloride - A61B 5/6833: {Adhesive patches} - A61B 5/743: {Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots} - A61B 5/1495: Calibrating or testing of in-vivo probes - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Systems are provided for an in vivo ketone sensor having a distal portion configured for placement in contact with an interstitial fluid of a user and a proximal portion including a working electrode, a sensing layer with β-hydroxybutyrate dehydrogenase, and a membrane layer configured to limit transport of one or more biomolecules. The in vivo ketone sensor is configured to generate signals at the working electrode corresponding to an amount of ketone in the interstitial fluid. Further, the systems includes a sensor control unit having at least one contact in electrical communication with the proximal portion of the sensor, which is configured to receive the generated signals, and convert the generated signals to ketone concentration data using a sensitivity associated with the in vivo ketone sensor. Also included is a transmitter configured to communicate ketone concentration data to a remote device. ## Claims ### Claim 1 A method for converting signals generated with an in vivo sensor to ketone concentration data, the method comprising: providing a ketone sensor having a distal portion configured for placement in contact with an interstitial fluid of a user and a proximal portion, the sensor comprising: a working electrode, a sensing layer comprising β-hydroxybutyrate dehydrogenase and free NAD, and a membrane; receiving signals corresponding to a ketone concentration in the interstitial fluid of the user in a sensor control unit; and converting, with the sensor control unit, the signals to the ketone concentration data based on a single predetermined calibration and a predetermined drift correction factor, wherein the predetermined drift correction factor accounts for an average daily signal loss as measured in vitro, and wherein the single predetermined calibration and the predetermined drift correction factor are suitable for use for 14 days; and displaying the ketone concentration data. ### Claim 2 (depends on 1) The method of claim 1, wherein the average daily signal loss is determined by disposing the in vivo sensor in a solution containing a known ketone concentration for a duration of time. ### Claim 3 (depends on 2) The method of claim 2, wherein the average daily signal loss is determined for subset of sensors from a manufacturing lot. ### Claim 4 (depends on 1) The method of claim 1, wherein the average daily signal loss is 0.15% when exposed to a phosphate buffer solution having 8 mM ketone at 37° C. over 14 days. ### Claim 5 (depends on 1) The method of claim 1, wherein the sensor control unit comprises: at least one contact in electrical communication with the proximal portion of the in vivo ketone sensor, and a transmitter configured to communicate the ketone concentration data to a remote device. ### Claim 6 (depends on 5) The method of claim 5, wherein the remote device comprises a display unit configured to display a graph of the in vivo ketone concentration over a period of time. ### Claim 7 (depends on 1) The method of claim 1, wherein the distal portion of the in vivo sensor further comprises a counter electrode. ### Claim 8 (depends on 7) The method of claim 7, wherein the sensing layer further comprises a redox mediator. ### Claim 9 (depends on 8) The method of claim 8, wherein the sensing layer further comprises diaphorase. ### Claim 10 (depends on 9) The method of claim 9, wherein the membrane is a mass transport limiting membrane for limiting the flux of ketones. ### Claim 11 (depends on 10) The method of claim 10, wherein the membrane is disposed over the sensing layer. ### Claim 12 (depends on 11) The method of claim 11, wherein the mass transport limiting membrane comprises a cross-linked polymer containing heterocylic nitrogen groups. ### Claim 13 (depends on 12) The method of claim 12, wherein mass transport limiting membrane comprises polyvinylpyridine. ### Claim 14 (depends on 1) The method of claim 1, wherein converting the signals to the ketone concentration data does not require calibration by the user. ### Claim 15 (depends on 14) The method of claim 14, wherein the single predetermined calibration is based on a predetermined in vitro sensitivity. ### Claim 16 (depends on 15) The method of claim 15, wherein the predetermined in vitro sensitivity is determined by measuring the electrical current in response to known ketone concentrations and performing a regression. ### Claim 17 (depends on 16) The method of claim 16, wherein the regression is linear. ### Claim 18 (depends on 16) The method of claim 16, wherein the predetermined in vitro sensitivity is determined for a subset of sensors from a manufacturing lot. ### Claim 19 (depends on 15) The method of claim 15, wherein the predetermined in vitro sensitivity correlates to an in vivo sensitivity over a concentration range of 0 mM to 8 mM. ### Claim 20 (depends on 19) The method of claim 19, wherein the predetermined in vitro sensitivity correlates to the in vivo sensitivity over a concentration range of 0 mM to 6 mM. ### Claim 21 (depends on 20) The method of claim 20, wherein the predetermined in vitro sensitivity correlates to the in vivo sensitivity over a concentration range of 0 mM to 5.1 mM. ### Claim 22 (depends on 14) The method of claim 14, wherein the single predetermined calibration comprises a predetermined in vivo background independent of the user for correcting the signals. ### Claim 23 (depends on 22) The method of claim 22, wherein the predetermined in vivo background is determined with a plurality of in vivo ketone sensors that do not comprise functional ketone sensing chemistry. ### Claim 24 A method for converting signals generated with an in vivo ketone sensor comprising a distal portion configured for contacting a user's interstitial fluid and a proximal portion configured to be positioned above a user's skin, to ketone concentration data, the method comprising: contacting the distal portion of the ketone sensor with the user's interstitial fluid to generate signals corresponding to a ketone concentration in the user's interstitial fluid, the distal portion of the ketone sensor comprising: a working electrode, a sensing layer comprising β-hydroxybutyrate dehydrogenase and free NAD, a membrane, and receiving the signals corresponding to the ketone concentration in a sensor control unit; and converting, with the sensor control unit, the signals to the ketone concentration data based on a single predetermined calibration and a predetermined drift correction factor, wherein the predetermined drift correction factor accounts for an average daily signal loss as measured in vitro, and wherein the single predetermined calibration and the predetermined drift correction factor are suitable for use for 14 days; and displaying the ketone concentration data.