# US 12,109,401 B2 · State estimation for drug delivery systems > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,109,401 B2 - Document ID: US12109401B2 - Status: Granted - Kind: B2 - Application number: 17/033,215 - Filed: 2020-09-25 - Published: 2021-01-14 - Granted: 2024-10-08 - Earliest claimed: 2018-03-29 - Assignees: Ypsomed AG - Applicants: Ypsomed AG - Inventors: Krista Kappeler; Leos Urbanek - Web page: https://patentgrep.com/patent/US12109401B2 ## CPC - A61M 5/3157: {Means providing feedback signals when administration is completed (A61M5/20 takes precedence)} - A61M 5/009: {Electronic or electro-mechanical add-on modules} - A61M 5/2033: {Spring-loaded one-shot injectors with or without automatic needle insertion (multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287)} - A61M 5/3245: {Constructional features thereof, e.g. to improve manipulation or functioning} - A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence) - A61M 2005/3267: {Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body} - A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means - A61M 2205/3584: using modem, internet or Bluetooth® - A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient - A61M 2205/581: by audible feedback - A61M 2205/582: by tactile feedback - A61M 2205/583: by visual feedback - A61M 2205/587: Lighting arrangements - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract A flexible and reliable delivery state estimator or evaluator is provided for a drug delivery device. The proposed delivery status estimation architecture includes a position sensor that provides a continuous position sensor signal indicative of a current position of a component of the delivery device movable continuously from a first to a second component position, as well as a position discriminator that redefines the continuous position sensor signal to generate an approximate binary input signal on behalf of a state estimator. The discriminator absorbs any difficulty that may arise from a limited reproducibility or enhanced variability of the original continuous sensor signal, specifically including a user-originated signal spread in a movement of a needle protection sleeve of the delivery device. ## Claims ### Claim 1 A method of evaluating a delivery status of a drug delivery device configured as an auto-injector with a container holding a liquid drug, comprising: providing, by a position sensor, a continuous position sensor signal indicative of an instantaneous position of a base of a spring of the delivery device movable from a first position to a second position; generating from the continuous position sensor signal, by a position discriminator, a binary position signal associated with the first position and the second position, wherein the binary position signal is indicative of whether the base of the spring is in the first position or the second position; and deriving, by a status evaluator, the delivery status from the binary position signal, wherein the delivery status comprises a detected start or end of injection of the liquid drug or a detected lift-off of the drug delivery device from a patient. ### Claim 2 (depends on 1) The method of claim 1, further comprising: (a) defining, by the position discriminator, for a continuous component position signal with a first value and a second value below the first value, a top slow tracker signal with predetermined relaxation properties; or (b) defining, by the position discriminator, for a continuous component position signal with a first value and a second value above the first value, a bottom slow tracker signal with predetermined relaxation properties; and using (a) or (b): determining a difference between an instantaneous value of the continuous component position signal and either one of the top slow tracker signal or the bottom slow tracker signal, and comparing the difference to a threshold to derive the binary position signal. ### Claim 3 (depends on 2) The method of claim 2, wherein a relaxation property of at least one slow tracker signal is determined by a linear drift parameter defining a linear variation of the slow tracker signal as long as an instantaneous value of the continuous component position signal does not exceed a top slow tracker signal value or fall below a bottom slow tracker signal value. ### Claim 4 (depends on 2) The method of claim 2, further comprising: defining, by the position discriminator, for the continuous component position signal with the second value below the first value, a fast bottom tracker signal smaller than and approximating the continuous component position signal; and determining the difference between the top slow tracker signal and the fast bottom tracker signal of the continuous component position signal; or defining, by the position discriminator, for the continuous component position signal with the second value above the first value, a fast top tracker signal larger than and approximating the continuous component position signal; and determining the difference between the fast top tracker signal and the bottom slow tracker signal of the continuous component position signal. ### Claim 5 (depends on 2) The method of claim 2, further comprising: comparing the difference to a second threshold to derive a discrete position signal being associated with the first component position, the second component position, and a third component position. ### Claim 6 (depends on 1) The method of claim 1, wherein the step of deriving the delivery status is based on a table assigning each delivery status to a combination of binary augmented sensor signals, further comprising: deriving the delivery status based on a preceding delivery status. ### Claim 7 A computer program which, when being executed by a processing unit of a monitoring unit of a drug delivery device configured as an auto-injector with a container holding a liquid drug, causes the processing unit to execute a method of evaluating a delivery status of the drug delivery device, comprising: providing, by a position sensor, a continuous position sensor signal indicative of an instantaneous position of a cover sleeve or a cover sleeve spring base of the delivery device movable from a first position to a second position; generating from the continuous position sensor signal, by a position discriminator, a binary position signal associated with the first position and the second position, wherein the binary position signal is indicative of whether the cover sleeve or the cover sleeve spring base is in the first position or the second position; and deriving, by a status evaluator, the delivery status from the binary position signal, wherein the delivery status comprises a detected start or end of injection of the liquid drug or a detected lift-off of the drug delivery device from a patient. ### Claim 8 (depends on 7) The computer program of claim 7 wherein the method of evaluating a delivery status of the drug delivery device further comprises: (a) defining, by the position discriminator, for a continuous component position signal with a first value and a second value below the first value, a top slow tracker signal with predetermined relaxation properties; or (b) defining, by the position discriminator, for a continuous component position signal with a first value and a second value above the first value, a bottom slow tracker signal with predetermined relaxation properties; and after (a) or (b): determining a difference between an instantaneous value of the continuous component position signal and either one of the top slow tracker signal or the bottom slow tracker signal; and comparing the difference to a threshold to derive the binary position signal. ### Claim 9 (depends on 8) The computer program of claim 8 wherein the method of evaluating a delivery status of the drug delivery device further comprises: wherein a relaxation property of the slow tracker signal is determined by a linear drift parameter defining a linear variation of the slow tracker signal as long as an instantaneous value of the continuous component position signal does not exceed a top slow tracker signal value or fall below a bottom slow tracker signal value. ### Claim 10 A monitoring unit for a drug delivery device configured as an auto-injector with a container holding a liquid drug, comprising: a position discriminator for generating, from a continuous position sensor signal provided by a position sensor and indicative of an instantaneous position of a cover sleeve or a cover sleeve spring base of the delivery device movable from a first component position to a second component position, a binary position signal associated with the first component position and the second component position, wherein the binary position signal is indicative of whether the cover sleeve or the cover sleeve spring base is in the first component position or the second component position; and a status evaluator for deriving a delivery status from the binary position signal, wherein the delivery status comprises a detected start or end of injection of the liquid drug or a detected lift-off of the drug delivery device from a patient. ### Claim 11 (depends on 10) The monitoring unit of claim 10, wherein the monitoring unit comprises: a position discriminator for generating, from a further continuous position sensor signal provided by a further position sensor and indicative of an instantaneous position of a further component of the delivery device movable from a first further component position to a second further component position, a further binary position signal associated with the first further component position and the second further component position; and a status evaluator configured to derive the delivery status from both of the binary position signal and the further binary position signal. ### Claim 12 (depends on 10) The monitoring unit of claim 10, further comprising the position sensor adapted to provide the continuous position sensor signal indicative of the instantaneous position of the base of the spring. ### Claim 13 (depends on 12) The monitoring unit of claim 12, wherein the position sensor is adapted to provide a continuous position sensor signal indicative of a distance of the delivery device from a target injection site. ### Claim 14 An electronic module for removable attachment to a drug delivery device configured as an auto-injector with a container holding a liquid drug, the module comprising a monitoring unit, comprising: a position discriminator for generating, from a continuous position sensor signal provided by a position sensor and indicative of an instantaneous position of a base of a spring of the drug delivery device movable from a first component position to a second component position, a binary position signal associated with the first component position and the second component position, wherein the binary position signal is indicative of whether the base of the spring is in the first component position or the second component position; and a status evaluator for deriving a delivery status from the binary position signal, wherein the delivery status comprises a detected start or end of injection of the liquid drug or a detected lift-off of the drug delivery device from a patient. ### Claim 15 (depends on 14) The electronic module of claim 14, further comprising a tag reader for reading information from a machine-readable tag mounted to a device housing of the drug delivery device, wherein the information comprises parameter values for the generation of the binary position signal by the position discriminator. ### Claim 16 (depends on 14) The electronic module of claim 14, wherein the monitoring unit further comprises: a position discriminator for generating, from a further continuous position sensor signal provided by a further position sensor and indicative of an instantaneous position of a further component of the delivery device movable from a first further component position to a second further component position, a further binary position signal associated with the first further component position and the second further component position; and a status evaluator configured to derive the delivery status from both of the binary position signal and the further binary position signal. ### Claim 17 (depends on 14) The electronic module of claim 14, wherein the monitoring unit comprises the position sensor adapted to provide the continuous position sensor signal indicative of the instantaneous position of the base of the spring. ### Claim 18 (depends on 17) The electronic module of claim 17, wherein the position sensor is adapted to provide a continuous position sensor signal indicative of a distance of the delivery device from a target injection site.