# US 11,992,659 B2 · Controllable drug delivery system and method of use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,992,659 B2 - Document ID: US11992659B2 - Status: Granted - Kind: B2 - Application number: 17/534,173 - Filed: 2021-11-23 - Published: 2022-08-18 - Granted: 2024-05-28 - Earliest claimed: 2014-06-03 - Assignees: Amgen Inc. - Applicants: Amgen Inc. - Inventors: Adam B. McCullough; Ferry Tamtoro; Huaying Yang; Mark Ka Lai Lee; Desheng Yin; Scott R. Gibson; Donald Busby; Peter V. Shultz; Keith P. Kogler; Basel Hasan Taha; Jimmie L. Ward; Christopher R. Folk; Steven William Badelt - Web page: https://patentgrep.com/patent/US11992659B2 ## CPC - A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence) - A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body} - A61M 5/14248: {of the skin patch type} - A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body} - A61M 5/24: Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic - A61M 5/31501: {Means for blocking or restricting the movement of the rod or piston (A61M5/5013 takes precedence)} - A61M 5/31568: {Means keeping track of the total dose administered, e.g. since the cartridge was inserted} - A61M 5/3202: {Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; protectors for sharps A61B50/3001)} - A61M 5/3243: {being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel (devices for protecting guide needles in combination with catheters A61M25/0612)} - A61M 5/3257: {Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means} - A61M 5/326: {Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user} - A61M 5/5086: {for indicating if defective, used, tampered with or unsterile} - G06Q 10/40: Business processes related to social networking or social networking services - G06Q 50/22: Social work or social welfare, e.g. community support activities or counselling services - G16H 20/17: delivered via infusion or injection - G16H 40/00: ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices - G16H 40/63: for local operation - G16H 40/67: for remote operation - A61M 2005/3267: {Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body} - A61M 2205/3331: Pressure; Flow - A61M 2205/3368: Temperature - A61M 2205/3553: remote, e.g. between patient's home and doctor's office - A61M 2205/3576: with non implanted data transmission devices, e.g. using external transmitter or receiver - A61M 2205/50: with microprocessors or computers - A61M 2205/502: User interfaces, e.g. screens or keyboards - A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient - A61M 2205/581: by audible feedback - A61M 2205/6009: for matching patient with his treatment, e.g. to improve transfusion security - 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)} - G06Q: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## Abstract A drug delivery system is disclosed that includes a drug delivery device having a reservoir, a delivery cannula having a proximal end in fluid communication with the reservoir and a distal end to be received within a patient, and one or more controllable elements. The drug delivery system may further include one or more sensors coupled to the drug delivery device, and a controller coupled to the one or more sensors and the one or more controllable elements. The controller may be configured to use the one or more sensors to determine a condition or an operational state of the drug delivery device. Furthermore, the controller may be configured to control the controllable element based on the condition or the operational state of the drug delivery device and/or identity information stored in a memory onboard the device. A method for use with a drug delivery device is also disclosed. ## Claims ### Claim 1 A drug delivery device comprising: a reservoir; a delivery member having a proximal end connected or configured to be connected in fluid communication with the reservoir and a distal end configured for insertion into a patient; a housing having an opening, the distal end of the delivery member being configured to extend through the opening in an operative state; an adhesive for removably coupling the housing to skin of the patient; a removable cover covering at least a portion of the adhesive; a controllable element; a patient contact sensor; and the drug delivery device being programmed or configured to: (a) determine if the at least a portion of the adhesive has been exposed, (b) determine if the drug delivery device is in contact with the patient, and (c) subsequent to or simultaneously with (b), output a control signal to the controllable element. ### Claim 2 (depends on 1) The drug delivery device of claim 1, comprising a controller programmed or configured to perform at least (b) and (c). ### Claim 3 (depends on 1) The drug delivery device of claim 1, wherein the opening is formed in an exterior surface of the housing and the adhesive is disposed at the exterior surface of the housing. ### Claim 4 (depends on 1) The drug delivery device of claim 1, wherein the removable cover comprises a sheet covering the adhesive and configured for removal by the patient or a user to expose the adhesive. ### Claim 5 (depends on 2) The drug delivery device of claim 2, wherein the controller is programmed to output the control signal to the controllable element if (b) does not occur within a predefined time period after (a). ### Claim 6 (depends on 2) The drug delivery device of claim 2, wherein the controller is programmed to repetitively determine at predefined time intervals if the drug delivery device is in contact with the patient. ### Claim 7 (depends on 1) The drug delivery device of claim 1, wherein the controllable element comprises a communication unit. ### Claim 8 (depends on 7) The drug delivery device of claim 7, wherein the communication unit, in response to the control signal, wirelessly transmits a report to an external computing device. ### Claim 9 (depends on 2) The drug delivery device of claim 2, wherein the drug delivery device is programmed to determine (a) if drug delivery is complete and (b) if the drug delivery device has been removed from contact with the patient and, if (a) and (b) are determined to exist, control the communication unit to transmit a report. ### Claim 10 (depends on 1) The drug delivery device of claim 1, wherein the controllable element comprises a lock. ### Claim 11 (depends on 10) The drug delivery device of claim 10, wherein the control signal changes the lock from a locked state to an unlocked state. ### Claim 12 (depends on 11) The drug delivery device of claim 11, comprising a plunger configured to expel a drug from the reservoir, wherein the lock, in the locked state, prevents movement of the plunger. ### Claim 13 (depends on 11) The drug delivery device of claim 11, comprising a trigger button operable by the patient, wherein the lock, in the locked state, prevents operation of the trigger button by the patient. ### Claim 14 (depends on 1) The drug delivery device of claim 1, wherein the controllable element comprises a circuit having a low-energy state and a high-energy state, and wherein the control signal switches the circuit from the low-energy state to the high-energy state. ### Claim 15 (depends on 1) The drug delivery device of claim 1, wherein the controllable element comprises a heating element configured to heat a drug in the reservoir or the delivery member in response to the control signal. ### Claim 16 (depends on 1) The drug delivery device of claim 1, wherein the patient contact sensor comprises at least one of a capacitance sensor, a resistance sensor, and an inductance sensor. ### Claim 17 (depends on 1) The drug delivery device of claim 1, wherein: the controllable element includes an output unit, and the drug delivery device is configured or programmed to activate the output unit to alert the patient or a user if the controller determines that the drug delivery device is not in contact with the patient. ### Claim 18 (depends on 17) The drug delivery device of claim 17, comprising a lock, wherein the drug delivery device is programmed or configured to activate the lock if the drug delivery device determines that the drug delivery device is not in contact with the patient. ### Claim 19 (depends on 1) The drug delivery device of claim 1, wherein the patient contact sensor is configured to form a closed electrical circuit when positioned in contact with the patient's skin or clothing. ### Claim 20 (depends on 1) The drug delivery device of claim 1, wherein the controller is programmed to output the control signal to the controllable element only if the controller has determined that at least: (i) the drug delivery device is in contact with the patient, and (ii) administration of a drug has been initiated or triggered. ### Claim 21 (depends on 20) The drug delivery device of claim 20, wherein the controllable element comprises an output unit configured to alert the patient upon receipt of the control signal.