# US 10,765,807 B2 · Fluid delivery device with sensor > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,765,807 B2 - Document ID: US10765807B2 - Status: Granted - Kind: B2 - Application number: 15/714,496 - Filed: 2017-09-25 - Published: 2018-03-29 - Granted: 2020-09-08 - Earliest claimed: 2016-09-23 - Assignees: Insulet Corporation - Applicants: Insulet Corporation - Inventors: Daniel Allis; Kenneth Phillips; Jacob Anthony Coumans - Web page: https://patentgrep.com/patent/US10765807B2 ## CPC - A61M 5/16854: {by monitoring line pressure} - A61M 5/14248: {of the skin patch type} - A61M 5/1452: {pressurised by means of pistons} - A61M 5/16831: {Monitoring, detecting, signalling or eliminating infusion flow anomalies (low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066)} - G16H 20/17: delivered via infusion or injection - A61M 5/16863: {Occlusion detection} - A61M 2005/14264: {with means for compensating influence from the environment} - A61M 2205/18: with alarm - A61M 2205/3331: Pressure; Flow - A61M 2205/3334: Measuring or controlling the flow rate - A61M 2205/3368: Temperature - A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates - A61M 2205/581: by audible feedback - A61M 2205/582: by tactile feedback - A61M 2205/583: by visual feedback - A61M 2205/70: with testing or calibration facilities - 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)} - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## Abstract A wearable drug delivery device for monitoring unintended over-delivery and/or under-delivery of a stored liquid drug are provided. An absolute pressure sensor can be positioned within the fluid path of the drug delivery device. The absolute pressor sensor can detect both ambient pressure (e.g., absolute or atmospheric pressure) and relative pressure (gage or pumping pressure). Based on the detected pressures, the effects of external ambient pressure on air with the fluid path can be determined during both intended drug delivery events and unintended drug delivery events. In turn, under-delivery and/or over-delivery of the liquid drug can be determined. Based on the severity of the determined under-delivery or over-delivery of the liquid drug, alarms indicating different urgencies can be provided to the user. ## Claims ### Claim 1 A method for controlling a pump system, the pump system having a housing and a monitoring component including circuitry, the method comprising: receiving by the monitoring component a first signal from a pressure sensor indicative of a first pressure at a start of a delivery operation for a liquid drug; determining by the monitoring component the first pressure at the start of the delivery operation for the liquid drug based on the received first signal; receiving a second signal from the pressure sensor indicative of a second pressure at an end of the delivery operation for the liquid; determining, by the monitoring component the second pressure at the end of the delivery operation for the liquid drug based on the received second signal; determining, by the monitoring component a fluid capacitance value of a fluid path used for the delivery operation of the liquid drug; determining an intended liquid drug delivery amount; determining a delivery error amount of the liquid drug based on the first and second pressures, the fluid capacitance value, and the intended liquid drug delivery amount; and in response to the determined delivery error amount, the monitoring component actuates an alarm actuator by outputting an alert-alarm signal to the alarm actuator, the alarm actuator configured to actuate an alarm. ### Claim 2 (depends on 1) The method of claim 1, further comprising determining the first and second pressures based on determining an absolute pressure. ### Claim 3 (depends on 2) The method of claim 2, further comprising comparing the delivery error amount to one or more thresholds. ### Claim 4 (depends on 3) The method of claim 3, further comprising determining an over-delivery condition when the delivery error amount is greater than a first threshold. ### Claim 5 (depends on 4) The method of claim 4, further comprising determining an under-delivery condition when the delivery error amount is less than a second threshold. ### Claim 6 (depends on 5) The method of claim 5, wherein the alarm includes a first alarm in response to the over-delivery condition, and a second alarm in response to the under-delivery condition, wherein the first and second alarms are different. ### Claim 7 (depends on 6) The method of claim 6, wherein the first and second alarms comprise at least one of an audible, a visual, and a tactile indication. ### Claim 8 (depends on 7) The method of claim 7, further comprising adjusting an indication of urgency of at least one of the first and second alarms based on a determined severity of the over-delivery condition and the under-delivery condition, respectively. ### Claim 9 (depends on 6) The method of claim 6, further comprising dynamically adjusting the first and second thresholds. ### Claim 10 (depends on 9) The method of claim 9, further comprising dynamically adjusting the first and second thresholds based on a de-rating factor based on a determined total amount of delivered liquid drug. ### Claim 11 (depends on 9) The method of claim 9, further comprising dynamically adjusting the first and second thresholds based on a de-rating factor based on a determined unmetabolized excess amount of over-delivered liquid drug. ### Claim 12 (depends on 9) The method of claim 9, further comprising determining a rate of change of atmospheric pressure. ### Claim 13 (depends on 12) The method of claim 12, further comprising dynamically adjusting the first and second thresholds based on the determined rate of change of the atmospheric pressure. ### Claim 14 (depends on 5) The method of claim 5, further comprising: determining a temperature; and dynamically adjusting the first and second thresholds based on the determined temperature. ### Claim 15 (depends on 1) The method of claim 1, further comprising determining an unintended delivery error amount of the liquid drug during a time outside of the delivery operation of the liquid drug. ### Claim 16 (depends on 15) The method of claim 15, further comprising: comparing the unintended delivery error amount to one or more unintended delivery thresholds, wherein the alarm is responsive to the comparison of the unintended delivery error amount to the one or more unintended delivery thresholds. ### Claim 17 An apparatus, comprising: a reservoir configured to hold a liquid drug; a fluid path component configured to couple the reservoir to a user; a plunger configured to expel the liquid drug from the reservoir for delivery to the user; an absolute pressure sensor configured to detect atmospheric pressure and relative pressure; and a monitoring component including circuitry configured to: receive a first signal from a pressure sensor indicative of a first pressure at a start of a delivery operation for a liquid; determine the first pressure at the start of the delivery operation for the liquid drug based on the received first signal; receive a second signal from the pressure sensor indicative of a second pressure at an end of the delivery operation for the liquid; determine the second pressure at the end of the delivery operation for the liquid drug based on the second signal; determine a fluid capacitance value of a fluid path used for the delivery operation of the liquid drug; determine an intended liquid drug delivery amount; determine a delivery error amount of the liquid drug based on the first and second pressures, the fluid capacitance value, and the intended liquid drug delivery amount; and in response to the determined delivery error amount, actuate an alarm actuator by outputting an alert-alarm signal, the alarm actuator configured to activate an alarm. ### Claim 18 (depends on 17) The apparatus of claim 17, wherein the plunger is directed to expel the liquid drug from the reservoir during an intended delivery operation and is directed to not expel the liquid drug from the reservoir during an unintended delivery operation. ### Claim 19 (depends on 18) The apparatus of claim 18, wherein the monitoring component indicates an over-delivery condition when the delivery error amount is greater than a first threshold and wherein the monitoring component indicates an under-delivery condition when the delivery error amount is less than a second, different threshold. ### Claim 20 (depends on 19) The apparatus of claim 19, wherein the monitoring component is configured to generate the alert-alarm signal based on a determined severity of at least one of the over-delivery condition and the under-delivery condition. ### Claim 21 (depends on 20) The apparatus of claim 20, wherein the alarm comprises at least one of a visual, an audible, and a tactile alert. ### Claim 22 (depends on 19) The apparatus of claim 19, wherein the monitoring component is configured to dynamically adjust the first and second thresholds. ### Claim 23 (depends on 22) The apparatus of claim 22, further comprising a temperature sensor, the monitoring component configured to dynamically adjust the first and second thresholds based on at least one of a determined temperature and a de-rating factor based on a determined total amount of delivered liquid drug. ### Claim 24 (depends on 1) The method of claim 1, wherein the first signal is received at first point in time and the second signal is received at a point in time later than when the first signal is received. ### Claim 25 (depends on 1) The method of claim 1, wherein the fluid capacitance changes in response to effective stiffness of a reservoir containing the liquid drug as a plunger is advanced further into the reservoir by a plunger drive mechanism coupled to the monitoring component.