# US 10,864,322 B2 · System and method for mitigating risk in automated medicament dosing > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,864,322 B2 - Document ID: US10864322B2 - Status: Granted - Kind: B2 - Application number: 15/848,163 - Filed: 2017-12-20 - Published: 2018-04-26 - Granted: 2020-12-15 - Earliest claimed: 2013-09-06 - Assignees: Tandem Diabetes Care, Inc. - Applicants: Tandem Diabetes Care, Inc. - Inventors: Sean Saint; Michael Rosinko - Web page: https://patentgrep.com/patent/US10864322B2 ## CPC - A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure} - A61M 5/14244: {adapted to be carried by the patient, e.g. portable on the body} - G16H 20/17: delivered via infusion or injection - G16H 40/63: for local operation - G16H 40/67: for remote operation - G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems - G16H 50/70: for mining of medical data, e.g. analysing previous cases of other patients - A61M 2005/14208: {with a programmable infusion control system, characterised by the infusion program} - A61M 2205/3523: using telemetric means - 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 2209/01: Remote controllers for specific apparatus - A61M 2230/005: Parameter used as control input for the apparatus - 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)} - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## Abstract A portable infusion pump can communicate with glucose monitor, such as a continuous glucose monitor (CGM), to receive continuous feedback relating to a user's blood glucose level during insulin or other medicament therapy and can automatically deliver insulin to a user when the CGM data indicates a need for additional insulin. Due to potential unreliability in the correlation of the CGM data to the user's actual blood glucose level, risk mitigation can be employed to limit the amount of extra insulin that can be delivered by the pump in response to the CGM data. ## Claims ### Claim 1 A portable infusion system, comprising: a delivery mechanism adapted to facilitate delivery of a medicament to a user; a memory adapted to store parameters relating to the delivery of the medicament; a communications device adapted to receive information from a continuous glucose monitor; a processor functionally linked to the delivery mechanism, the memory and the communications device, the processor configured to: obtain the information from the continuous glucose monitor; store in a memory a threshold relating to predicted accuracy of the continuous glucose monitor after which automatic adjustment of the delivery of the medicament based on the information from the continuous glucose monitor is not permitted; monitor the information received from the continuous glucose monitor; determine that the threshold has been reached; disable automatic adjustment of the delivery of the medicament based on the information from the continuous glucose monitor if it is determined that the threshold has been reached. ### Claim 2 (depends on 1) The portable infusion system of claim 1, wherein the threshold is set as an amount of time that has elapsed since a most recent calibration of the continuous glucose monitor. ### Claim 3 (depends on 2) The portable infusion system of claim 2, wherein the processor is configured to determine that the continuous glucose monitor has been calibrated and re-enable automatic adjustment after determining that the continuous glucose monitor has been calibrated. ### Claim 4 (depends on 3) The portable infusion system of claim 3, wherein the processor automatically re-enables automatic adjustment after determining that the continuous glucose monitor has been calibrated. ### Claim 5 (depends on 2) The portable infusion system of claim 2, wherein the amount of time is 12 hours. ### Claim 6 (depends on 1) The portable infusion system of claim 1, wherein the threshold is set as a maximum predicted error of the continuous glucose monitor. ### Claim 7 (depends on 1) The portable infusion system of claim 1, wherein the threshold is set as a maximum difference between a blood glucose level at a most recent calibration of the continuous glucose monitor and a current estimated blood glucose level of the continuous glucose monitor. ### Claim 8 (depends on 1) The portable infusion system of claim 1, wherein the processor is a part of an ambulatory infusion pump that includes the delivery mechanism. ### Claim 9 (depends on 1) The portable infusion system of claim 1, wherein the processor is further configured to provide a notification on a user interface that automatic adjustment of the delivery of the medicament has been disabled. ### Claim 10 (depends on 9) The portable infusion system of claim 9, wherein the user interface is part of an ambulatory infusion pump that includes the delivery mechanism. ### Claim 11 A portable infusion system, comprising: a delivery mechanism adapted to facilitate delivery of a medicament to a user; a memory adapted to store parameters relating to the delivery of the medicament; a communications device adapted to receive information from a continuous glucose monitor; a processor functionally linked to the delivery mechanism, the memory and the communications device, the processor configured to: obtain the information from the continuous glucose monitor; enable automated dosing during which at least some delivery of the medicament to the user is automatically adjusted based on the information from the continuous glucose monitor; store a predetermined time limit for automated dosing, the predetermined time limit determined based on a predicted reliability of the information from the continuous glucose monitor; disable automated dosing upon determining that the predetermined time limit has been reached. ### Claim 12 (depends on 11) The portable infusion system of claim 11, wherein the predetermined time limit is based on a time since a most recent calibration of the continuous glucose monitor. ### Claim 13 (depends on 12) The portable infusion system of claim 12, further comprising: receiving an indication that the continuous glucose monitor has been calibrated; and resetting the predetermined time limit after receiving the indication that the continuous glucose monitor has been calibrated. ### Claim 14 (depends on 12) The portable infusion system of claim 12, wherein the processor is configured to determine that the continuous glucose monitor has been calibrated and re-enable automated dosing after determining that the continuous glucose monitor has been calibrated. ### Claim 15 (depends on 14) The portable infusion system of claim 14, wherein the processor automatically re-enables automated dosing after determining that the continuous glucose monitor has been calibrated. ### Claim 16 (depends on 11) The portable infusion system of claim 11, wherein the processor is a part of an ambulatory infusion pump that includes the delivery mechanism. ### Claim 17 (depends on 11) The portable infusion system of claim 11, wherein the processor is further configured to provide a notification on a user interface that automated dosing has been disabled. ### Claim 18 (depends on 17) The portable infusion system of claim 17, wherein the user interface is part of an ambulatory infusion pump that includes the delivery mechanism.