# US 11,896,808 B2 · Smart vial adapter and method > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,896,808 B2 - Document ID: US11896808B2 - Status: Granted - Kind: B2 - Application number: 17/842,364 - Filed: 2022-06-16 - Published: 2022-09-29 - Granted: 2024-02-13 - Earliest claimed: 2018-01-12 - Assignees: Becton, Dickinson and Company - Applicants: Becton, Dickinson and Company - Inventors: Tianqi Hang; Uzair Siddiqui - Web page: https://patentgrep.com/patent/US11896808B2 ## CPC - A61M 5/31546: {Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons} - A61J 1/1406: {Septums, pierceable membranes} - A61J 1/201: {having one piercing end} - A61J 1/2055: {having gripping means} - A61J 1/2096: {Combination of a vial and a syringe for transferring or mixing their contents} - A61M 5/28: Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle - A61M 5/3129: {Syringe barrels (A61M5/3205, A61M5/50 take precedence)} - A61M 5/31566: {Means improving security or handling thereof} - B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like} - G16H 20/13: delivered from dispensers - G16H 20/17: delivered via infusion or injection - G16H 40/63: for local operation - G16H 40/67: for remote operation - A61J 2200/70: Device provided with specific sensor or indicating means - A61M 5/178: Syringes - A61M 5/482: {Varying injection pressure, e.g. by varying speed of injection} - A61M 2005/3125: {Display means, e.g. to indicate dose setting} - A61M 2205/3569: sublocal, e.g. between console and disposable - A61M 2205/3584: using modem, internet or Bluetooth® - A61M 2205/502: User interfaces, e.g. screens or keyboards - 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)} - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE - B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## Abstract A smart vial adapter is capable of measuring the dose of a drug that is withdrawn from a vial, measuring the time of a dose capture event, monitoring the vial temperature, measuring the amount of motion or perturbation the vial is subjected to, capturing various other parameters that can provide additional insights associated with the drug or the amount of the dose being drawn from the vial, and communicating the recorded information to a companion application on a computer, smartphone or other device. Related methods are also disclosed and claimed. ## Claims ### Claim 1 A system including an electronic device connected to a vial adapter, the system comprising: the vial adapter including: a housing having a sensor cavity, a first end configured to be attached to a vial and a second end having a fluid port sealed by a penetrable septum; a vial access cannula having an internal lumen, the vial access cannula affixed to the housing and communicating with the fluid port, the vial access cannula being positioned within the first end of the housing for penetrating a septum of a vial attached to the housing, the sensor cavity of the vial adapter being open to the internal lumen; electrical components contained within the housing for performing at least one of dose capture, condition monitoring and information reporting function with respect to a drug that is contained in or drawn from a vial attached to the housing; and a microcontroller communicating with the electrical components to provide instructions and record data; and the electronic device including: a display communicating with the microcontroller of the vial adapter to display the data recorded based on the instructions received. ### Claim 2 (depends on 1) The system of claim 1, wherein the vial adapter further comprises: an electronic flow sensor; wherein the electronic flow sensor surrounds the internal lumen of the vial access cannula for sensing fluid flow within the vial access cannula. ### Claim 3 (depends on 2) The system of claim 2, wherein the electronic flow sensor of the vial adapter is disposed in the sensor cavity of the housing. ### Claim 4 (depends on 1) The system of claim 1, wherein the housing of the vial adapter includes an internal fluid chamber between the fluid port and the vial access cannula, the internal fluid chamber being sealed by the septum and communicating with the internal lumen of the vial access cannula through an opening that allows air and liquid to move freely in either direction between the internal fluid chamber and an interior of the vial through the internal lumen of the vial access cannula. ### Claim 5 (depends on 1) The system of claim 1, wherein the electrical components contained within the vial adapter include one or more of a flow sensor, a thermal sensor, an accelerometer, a microcontroller, a visual indicator, an audible indicator and a Bluetooth® wireless module. ### Claim 6 (depends on 1) The vial adapter of claim 1, wherein the electrical components of the vial adapter are received in an internal cavity of the housing that is adjacent to an internal fluid chamber. ### Claim 7 (depends on 1) The system of claim 1, wherein the housing of the vial adapter includes an electrically powered air pump and an air filter to force filtered air into the vial before a dose of the drug is drawn into a syringe from the vial; and the electronic device is configured to remotely and wirelessly communicate with the vial adapter. ### Claim 8 (depends on 1) The system of claim 1, wherein the display of the electronic device presents at least one of a number of injections administered, a percentage of blood glucose measurements within a desired range, a bar chart showing an amount of insulin administered in each injection, and a line chart showing blood glucose level over time. ### Claim 9 (depends on 1) The system of claim 1, wherein the display of the electronic device presents an events panel to pair the blood glucose measurements with injection events. ### Claim 10 (depends on 1) The system of claim 1, wherein the display of the electronic device presents a user's statistics over a 7-day period. ### Claim 11 (depends on 10) The system of claim 10, wherein the display of the electronic device presents the user's statistics over the 7-day period includes one of estimated A1c level based on injection and glucose data for the 7-day period, a total number and daily average of blood glucose measurements over the 7-day period, a number of in-range, below-range and above-range blood glucose measurements making up the 7-day total, and a number of balanced, hypoglycemic and hyperglycemic days within the 7-day period. ### Claim 12 (depends on 1) The system of claim 1, wherein the display of the electronic device presents at least one of the following: (a) the number of doses withdrawn from the vial during a predetermined period of time; (b) the dosage amount for each of a plurality of doses withdrawn from the vial during a predetermined period of time; (c) dosage events paired with contemporaneously measured physiological data; and (d) estimated or projected physiological data based on dosage history. ### Claim 13 (depends on 1) The system of claim 1, wherein the electronic device includes a computer, a smartphone or other mobile device that is programmed with a software application for processing the data and providing a user output, the electronic device is separate and independent from the vial adapter.