# US 10,441,717 B2 · Monitoring a physiological parameter associated with tissue of a host to confirm delivery of medication > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,441,717 B2 - Document ID: US10441717B2 - Status: Granted - Kind: B2 - Application number: 14/253,271 - Filed: 2014-04-15 - Published: 2015-10-15 - Granted: 2019-10-15 - Earliest claimed: 2014-04-15 - Assignees: Insulet Corporation - Applicants: Insulet Corporation - Inventors: Kevin Guido Schmid; Steven Dilanni; Robert W. Campbell; Ian T. McLaughlin; Jason B. O'Connor - Web page: https://patentgrep.com/patent/US10441717B2 ## CPC - A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure} - A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement} - A61B 5/14865: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors} - A61B 5/4839: {combined with drug delivery} - A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body} - A61M 5/14248: {of the skin patch type} - G16H 20/17: delivered via infusion or injection - A61M 2005/1726: {the body parameters being measured at, or proximate to, the infusion site} - A61M 2230/201: Glucose concentration - 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)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## Abstract A physiological parameter associated with tissue of a host may be monitored in the tissue to confirm subcutaneous delivery of medication to the host. More particularly, such may involve delivering medication subcutaneously to the host with a medical device which includes a sensor used to measure the physiological parameter, particularly within a predetermined time period after delivery of the medication. Such may also or otherwise involve forming a depot in the tissue with the medication, and using the sensor to measure the physiological parameter while the sensor is at least partially within the depot. ## Claims ### Claim 1 A method of treating a host with a medication, the method comprising: providing a medication delivery device which deliver the medication into a tissue of the host, wherein the medication delivery device includes a sensor, and wherein the sensor is used to measure a physiological parameter of the tissue; introducing the medication delivery device including the sensor into the tissue such that the tissue is in contact with the sensor; delivering the medication into the tissue of the host; forming a depot in the tissue with the medication, the depot formed such that the sensor is at least partially within the depot with the depot disposed between the sensor and the tissue, wherein the depot is disposed between the sensor and the tissue such that the depot reduces the tissue contact with the sensor; confirming delivery of the medication from the medication delivery device to the host, wherein confirming delivery of the medication comprises using the sensor to measure the physiological parameter of the tissue within a predetermined time period after delivery of the medication and while the sensor is at least partially within the depot with the depot disposed between the sensor and the tissue. ### Claim 2 (depends on 1) The method of claim 1 wherein: the tissue in contact with the sensor comprises extracellular fluid; and the depot reduces contact of the extracellular fluid with the sensor. ### Claim 3 (depends on 2) The method of claim 2 wherein: the depot reduces contact of the extracellular fluid with the sensor by the depot at least partially surrounding the sensor within the depot. ### Claim 4 (depends on 1) The method of claim 1 wherein: the predetermined time period is less than a time required for the depot to be completely absorbed into the tissue and the tissue reestablishes contact with the sensor where the depot was located. ### Claim 5 (depends on 1) The method of claim 1 wherein: the predetermined time period is in a range of 0.1 second to 600 seconds. ### Claim 6 (depends on 5) The method of claim 5 wherein: the predetermined time period is in a range of 0.1 second to 120 seconds. ### Claim 7 (depends on 1) The method of claim 1 wherein: delivering the medication into the tissue of the host further comprises delivering the medication into subcutaneous tissue of the host. ### Claim 8 (depends on 1) The method of claim 1 wherein: the sensor comprises a glucose sensor. ### Claim 9 (depends on 1) The method of claim 1 wherein: the physiological parameter is glucose concentration level. ### Claim 10 (depends on 1) The method of claim 1 wherein: confirming delivery of the medication from the medication delivery device to the host further comprises: determining a value of the physiological parameter measured within the predetermined time period after delivery of the medication; providing a predetermined representative value for the physiological parameter with the medication delivery device; and determining that the measured value of the physiological parameter within the predetermined time period after delivery of the medication is less than the predetermined representative value for the physiological parameter provided by the medication delivery device. ### Claim 11 (depends on 1) The method of claim 1 further comprising: after introducing the medication delivery device including the sensor into the tissue, using the sensor to measure the physiological parameter before delivering the medication into the tissue; and wherein confirming delivery of the medication from the medication delivery device to the host further comprises: determining a value of the physiological parameter measured before delivering the medication; determining a value of the physiological parameter measured within the predetermined time period after delivery of the medication; and determining that the value of the physiological parameter measured within the predetermined time after delivery of the medication is less than the value of the physiological parameter measured before delivering the medication into the tissue. ### Claim 12 (depends on 1) The method of claim 1 further comprising: after introducing the medication delivery device including the sensor into the tissue, using the sensor to measure the physiological parameter before delivering the medication into the tissue; wherein confirming delivery of the medication from the medication delivery device to the host further comprises: determining a value of the physiological parameter measured before delivering the medication; determining a value of the physiological parameter measured within the predetermined time period after delivery of the medication; determining a numerical difference between the value of the physiological parameter measured before delivering the medication into the tissue, and the value of the physiological parameter measured within the predetermined time after delivering the medication into the tissue; providing a predetermined representative value for the numerical difference of the physiological parameter with the medication delivery device; and determining the numerical difference between the two measured values of the physiological parameter is greater than a predetermined representative value for the numerical difference provided by the medication delivery device. ### Claim 13 (depends on 12) The method of claim 12 wherein: the physiological parameter is interstitial glucose concentration level; and a predetermined representative value for the numerical difference provided by the medication delivery device is at least 20 mg/dL. ### Claim 14 (depends on 1) The method of claim 1 further comprising: after introducing the medication delivery device including the sensor into the tissue, using the sensor to measure the physiological parameter before delivering the medication into the tissue; wherein confirming delivery of the medication from the medication delivery device to the host further comprises: determining a value of the physiological parameter measured before delivering the medication; determining a value of the physiological parameter measured within the predetermined time period after delivery of the medication; determining a percentage change between the value of the physiological parameter measured before delivering the medication into the tissue, and the value of the physiological parameter measured within the predetermined time after delivering the medication into the tissue; providing a predetermined representative value for the percentage change of the physiological parameter with the medication delivery device; and determining the percentage change between the two measured values of the physiological parameter is greater than a predetermined representative value for the percentage change provided by the medication delivery device. ### Claim 15 (depends on 14) The method of claim 14 wherein: the physiological parameter is interstitial glucose concentration level; and a predetermined representative value for the percentage change provided by the medication delivery device is at least 15%. ### Claim 16 (depends on 1) The method of claim 1 wherein: confirming delivery of the medication from the medication delivery device to the host further comprises: determining a value of the physiological parameter while the sensor is within the depot; providing a predetermined representative value for the physiological parameter with the medication delivery device; and after delivery of the medication, determining that the measured value of the physiological parameter while the sensor is within the depot is less than the predetermined representative value for the physiological parameter provided by the medication delivery device. ### Claim 17 (depends on 1) The method of claim 1 further comprising: after introducing the medication delivery device including the sensor into the tissue, using the sensor to measure the physiological parameter before delivering the medication into the tissue; and wherein confirming delivery of the medication from the medication delivery device to the host further comprises: determining a value of the physiological parameter measured before delivering the medication; after delivery of the medication, determining a value of the physiological parameter measured while the sensor is within the depot; and determining that the value of the physiological parameter measured while the sensor is within the depot is less than the value of the physiological parameter measured before delivering the medication into the tissue. ### Claim 18 (depends on 1) The method of claim 1 further comprising: after introducing the medication delivery device including the sensor into the tissue, using the sensor to measure the physiological parameter before delivering the medication into the tissue; wherein confirming delivery of the medication from the medication delivery device to the host further comprises: determining a value of the physiological parameter measured before delivering the medication; after delivery of the medication, determining a value of the physiological parameter measured while the sensor is within the depot; determining a numerical difference between the value of the physiological parameter measured before delivering the medication into the tissue, and the value of the physiological parameter measured while the sensor is within the depot; providing a predetermined representative value for the numerical difference of the physiological parameter with the medication delivery device; and determining the numerical difference between the two measured values of the physiological parameter is greater than a predetermined representative value for the numerical difference provided by the medication delivery device. ### Claim 19 (depends on 1) The method of claim 1 further comprising: after introducing the medication delivery device including the sensor into the tissue, using the sensor to measure the physiological parameter before delivering the medication into the tissue; wherein confirming delivery of the medication from the medication delivery device to the host further comprises: determining a value of the physiological parameter measured before delivering the medication; after delivery of the medication, determining a value of the physiological parameter measured while the sensor is within the depot; determining a percentage change between the value of the physiological parameter measured before delivering the medication into the tissue, and the value of the physiological parameter measured while the sensor is within the depot; providing a predetermined representative value for the percentage change of the physiological parameter with the medication delivery device; and determining the percentage change between the two measured values of the physiological parameter is greater than a predetermined representative value for the percentage change provided by the medication delivery device. ### Claim 20 (depends on 1) The method of claim 1 wherein: the medication delivery device includes a cannula. ### Claim 21 (depends on 1) The method of claim 1 further comprising: forming the depot in the tissue with the medication, the depot formed such that the sensor is completely within the depot with the depot disposed between the sensor and the tissue, wherein the depot disposed between the sensor and the tissue separates the tissue from the sensor such that the depot reduces the tissue contact of the tissue with the sensor.