# US 8,464,707 B2 · Compliance monitor and method > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,464,707 B2 - Document ID: US8464707B2 - Status: Granted - Kind: B2 - Application number: 10/572,316 - Filed: 2004-09-22 - Published: 2007-02-01 - Granted: 2013-06-18 - Earliest claimed: 2003-09-24 - Assignees: Takeda GmbH - Applicants: Roberto Jongejan; Antje-Henriette Fink-Wagner; Christopher Ferris - Inventors: Roberto Jongejan; Antje-Henriette Fink-Wagner; Christopher Ferris - Web page: https://patentgrep.com/patent/US8464707B2 ## CPC - A61M 15/009: {using medicine packages with incorporated spraying means, e.g. aerosol cans (pocket atomiser of the injector type A61M11/08)} - A61M 2205/13: with means for the detection of operative contact with patient, e.g. lip sensor - A61M 2205/3368: Temperature - A61M 2205/3569: sublocal, e.g. between console and disposable - A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient - 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 compliance monitor (20) is attachable to or forms part of a drug delivery device, such as an inhaler (2). The monitor comprises a flexible portion (38) to enable a switch which is actuated by a user when delivering a dose of medicament. The monitor further comprises a sensor for sensing whether the device is properly positioned in contact with or relative to the user's body for administration of the medicament. For example, where the device is an inhaler and the sensor a temperature sensor, temperature variations caused by insertion of an inhaler mouthpiece into the user's mouth indicate whether the dose has been delivered into the patient's mouth. A memory in the compliance monitor stores a compliance record indicating whether or not the device was properly positioned each time a dose was delivered. ## Claims ### Claim 1 A compliance monitor for a drug delivery device with a mouthpiece for administering a drug, comprising: a switch actuatable by a user on delivering a dose from a drug delivery device; a sensor for detecting whether the device is properly positioned in contact with or relative to the user's body for delivery of the dose; and a processor coupled to the switch and the sensor for recording whether or not the device was properly positioned when the switch was actuated; wherein the compliance monitor is removably attachable to the mouthpiece of the drug delivery device; wherein the sensor is a temperature sensor for sensing body temperature and the temperature sensor is mounted so that the temperature sensor enters or contacts the user's mouth when the mouthpiece is placed in the mouth, and wherein the compliance monitor comprises a housing and the sensor is mounted at the end of a protruding portion of the housing such that the sensor does not affect the normal operation of the drug delivery device. ### Claim 2 (depends on 1) The compliance monitor according to claim 1, comprising a clock coupled to the processor and in which the time of actuation of the switch is recorded. ### Claim 3 (depends on 1) The compliance monitor according to claim 1, wherein the drug delivery device is an inhaler operated by the user depressing a pressurized canister containing the drug, and wherein the switch is a pressure-operated switch actuatable as the user depresses the canister. ### Claim 4 (depends on 1) The compliance monitor according to claim 1, in which a change in an output of a sensor characteristic of correct use of the drug delivery device is used to determine whether the device was properly positioned when the dose was delivered. ### Claim 5 (depends on 1) The compliance monitor according to claim 1, further comprising an output for downloading data to a docking station or a computer. ### Claim 6 (depends on 1) The compliance monitor according to claim 1, in which data recorded comprises a compliance record of use of the drug delivery device, including a record of whether the sensor output indicates that the device was properly positioned on each occasion that a dose has been delivered. ### Claim 7 (depends on 1) A docking station for use with the compliance monitor as defined in claim 1, the docking station and the compliance monitor comprising respective contacts. ### Claim 8 (depends on 1) A combination compliance monitor for a drug delivery device and non-transitory computer-readable medium carrying a computer program for programming a general purpose computer to receive and process data downloaded from a compliance monitor, the combination comprising: a compliance monitor according to claim 1; and a non-transitory computer-readable medium carrying a computer program for programming a general purpose computer to receive and process data downloaded from the compliance monitor according to claim 1. ### Claim 9 (depends on 1) A drug delivery device comprising a compliance monitor as defined in claim 1. ### Claim 10 (depends on 1) A method of using a compliance monitor as defined in claim 1, to monitor use of a drug delivery device for administration of a drug, comprising the steps of: determining when a user operates the device to deliver a dose of the drug; sensing whether the device is properly positioned in contact with or relative to the user's body when the dose is delivered; and recording for each operation of the device whether or not the device was properly positioned. ### Claim 11 (depends on 10) The method according to claim 10, further comprising the step of determining and recording the time of each operation of the device. ### Claim 12 (depends on 10) The method according to claim 10, in which the drug delivery device is for oral administration of the drug and proper positioning of the device is proper positioning in the user's mouth. ### Claim 13 (depends on 10) The method according to claim 10, further comprising the step of downloading recorded data from the compliance monitor to a docking station or a computer to allow a compliance record to be reviewed.