# US 11,433,177 B2 · Infusion system which utilizes one or more sensors and additional information to make an air determination regarding the infusion system > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,433,177 B2 - Document ID: US11433177B2 - Status: Granted - Kind: B2 - Application number: 16/233,740 - Filed: 2018-12-27 - Published: 2019-09-05 - Granted: 2022-09-06 - Earliest claimed: 2013-05-29 - Assignees: ICU Medical, Inc. - Applicants: ICU Medical, Inc. - Inventors: Meriyan Oruklu; Timothy L. Ruchti; Paul T. Kotnik; Anatoly S. Belkin - Web page: https://patentgrep.com/patent/US11433177B2 ## CPC - A61M 5/142: Pressure infusion, e.g. using pumps - A61M 5/1684: {by detecting the amount of infusate remaining, e.g. signalling end of infusion} - A61M 5/365: {Air detectors (A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626)} - A61M 2205/18: with alarm - A61M 2205/332: Force measuring means - A61M 2205/3331: Pressure; Flow - A61M 2205/3334: Measuring or controlling the flow rate - A61M 2205/3368: Temperature - 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)} ## Abstract In one step of a method for infusing an infusion fluid, the infusion fluid is pumped through a fluid delivery line of an infusion system. In another step, measurements are taken with at least one sensor connected to the infusion system. In an additional step, an air determination is determined with at least one processor. The air determination is related to air in the fluid delivery line. The air determination is based on the measurements taken by the at least one sensor. The air determination is further based on: (1) medication information regarding the infusion fluid or infusion information regarding the infusion of the infusion fluid; or (2) multi-channel filtering of the measurements from the at least one sensor or non-linear mapping of the measurements from the at least one sensor; and statistical process control charts applied to the multi-channel filtered measurements or applied to the non-linear mapped measurements. ## Claims ### Claim 1 An infusion system configured to be connected to a fluid delivery line and to an infusion container containing an infusion fluid, the infusion system comprising: a pump; at least one sensor connected to the pump or the fluid delivery line, the at least one sensor configured to output a force profile at each sampling step; at least one processor in electronic communication with the pump and the at least one sensor; and a memory in electronic communication with the at least one processor, the memory comprising programming code for execution by the at least one processor; wherein the programming code is configured to cause the at least one processor to determine a total volume of infusion fluid infused at each sampling step and determine an air determination related to the air in the fluid delivery line based on statistical process control charts applied to multi-channel filtered measurements including the determined total volume of infusion fluid infused and the force profile from the at least one sensor. ### Claim 2 (depends on 1) The infusion system of claim 1, wherein the at least one sensor comprises a plunger force sensor, the plunger force sensor positioned on the pump. ### Claim 3 (depends on 1) The infusion system of claim 1, wherein the multi-channel filtered measurements comprise measurements filtered by a plurality of Kalman filters. ### Claim 4 (depends on 3) The infusion system of claim 3, wherein the plurality of Kalman filters comprise: a first Kalman filter configured to estimate mean force, a second Kalman filter configured to estimate variance force, and a third Kalman filter configured to estimate derivative force. ### Claim 5 (depends on 1) The infusion system of claim 1, wherein the statistical process control charts comprise a calculation of a residual value, the residual value comprising the difference between an actual signal characteristic measured by the at least one sensor and a predicted signal characteristic of the signal measured by the at least one sensor. ### Claim 6 (depends on 5) The infusion system of claim 5, wherein the statistical process control charts comprise a cumulative sum control chart. ### Claim 7 (depends on 6) The infusion system of claim 6, wherein the cumulative sum control chart comprises a cumulative sum of the residual values in a positive direction and a cumulative sum of the residual values in a negative direction. ### Claim 8 (depends on 1) The infusion system of claim 1, wherein the statistical process control charts comprise an exponentially moving average control chart. ### Claim 9 An infusion system configured to be connected to a fluid delivery line and to an infusion container containing an infusion fluid, the infusion system comprising: a pump; at least one sensor connected to the pump or the fluid delivery line, the at least one sensor configured to output a force profile at each sampling step; at least one processor in electronic communication with the pump and the at least one sensor; and a memory in electronic communication with the at least one processor, wherein the memory comprises programming code for execution by the each at least one processor, and the programming code is configured to cause the at least one processor to determine an air determination related to the air in the fluid delivery line based on: (a) the force profile taken by the at least one sensor, (b) medication information regarding the infusion fluid, and (c) total volume of infusion fluid infused at each sampling step. ### Claim 10 (depends on 9) The infusion system of claim 9, wherein the medication information comprises a duration of the infusion fluid and the infusion information comprises a volume of the infused fluid in the infusion container. ### Claim 11 (depends on 9) The infusion system of claim 9, wherein the air determination is further determined by statistical process control charts applied to the measurements taken by the at least one sensor. ### Claim 12 (depends on 9) The infusion system of claim 9, wherein the air determination comprises determining an end-of-container event when the infusion container has been emptied of the infusion fluid. ### Claim 13 An infusion system configured to be connected to a fluid delivery line and to an infusion container containing an infusion fluid, the infusion system comprising: a pump; at least one sensor connected to the pump or the fluid delivery line, the at least one sensor configured to output a force profile; at least one processor in electronic communication with the pump and the at least one sensor; and a memory in electronic communication with the at least one processor, the memory comprising programming code for execution by the at least one processor; wherein the programming code is configured to cause the at least one processor to determine an air determination related to the air in the fluid delivery line based on: (a) a total volume of infusion fluid infused; and (b) statistical process control charts applied to multi-channel filtered measurements including the determined total volume of infusion fluid infused and the force profile, wherein the multi-channel filtered measurements comprise measurements filtered by a plurality of Kalman filters.