Systems, apparatuses and methods for occlusion detection using pump operation measurement

Patent metadata

Field	Value
Publication number	US-12156989-B2
Application number	US-201916967330-A
Country	US
Kind code	B2
Filing date	Jan 29, 2019
Priority date	Feb 6, 2018
Publication date	Dec 3, 2024
Grant date	Dec 3, 2024

Abstract

A technical solution for monitoring operation of a medical delivery device such as an infusion pump for occlusion is provided that employs sensing pump motor current and monitoring average motor current difference as between dispense and aspirate strokes in a pump cycle. The solution can be implemented alone or in combination with other occlusion sensing methods that use one or more of pump measurement data such as pump stroke duration (e.g., duration of aspirate stroke or dispense stroke in a rotational metering-type pump or a reciprocating-type pump), end-stop or limit switch activation, and duration difference between aspirate and dispense strokes to detect occlusion.

First claim

The invention claimed is:

1. An infusion device with integral occlusion sensing comprising:
a pump comprising a chamber configured with at least one port to receive fluid into the chamber from a reservoir and through which the fluid flows out of the chamber, and a pumping mechanism configured to operate for a plurality of pump cycles wherein each pump cycle among the plurality of pump cycles comprises an aspirate stroke and a dispense stroke, and to control aspiration of a volume of the fluid into the chamber during the aspirate stroke of each pump cycle among the plurality of pump cycles and to control dispensing of a volume of the fluid from the chamber during the dispense stroke of each pump cycle among the plurality of pump cycles;
a pump measurement device configured to generate pump measurements related to a respective stroke in each pump cycle among the plurality of pump cycles, the respective stroke chosen from the aspirate stroke of each pump cycle among the plurality of pump cycles performed by the pump, and the dispense stroke of each pump cycle among the plurality of pump cycles performed by the pump;
a processing device configured to analyze the pump measurements and determine when the pump measurements comprise a plurality of the pump measurements that satisfy a predetermined metric designated as an indication of an occlusion; and
wherein the pump measurement device comprises a current sensing device configured to detect a pumping mechanism current during the respective stroke in each pump cycle among the plurality of pump cycles;
wherein the pump measurements correspond to the pumping mechanism current detected during the respective stroke in each pump cycle among the plurality of pump cycles; and
wherein the predetermined metric comprises an average pumping mechanism current among the respective strokes that exceeds a designated current value that is higher than an average value of the pumping mechanism current when no occlusion is occurring in the pump, the processing device being configured to determine the average pumping mechanism current as a mean of values of the pumping mechanism current over time.

2. The infusion device with integral occlusion sensing of claim 1 , further comprising an indicator, the processing device being configured to operate the indicator as an occlusion alert in response to a determination that the plurality of the pump measurements satisfy the predetermined metric.

3. The infusion device with integral occlusion sensing of claim 1 , wherein the processing device is configured to automatically terminate operation of the pumping mechanism in response to a determination that the plurality of the pump measurements satisfy the predetermined metric.

4. The infusion device with integral occlusion sensing of claim 1 , wherein the pump measurements further comprise a time duration related to at least one of the aspirate stroke and the dispense stroke in each pump cycle among the plurality of pump cycles.

5. The infusion device with integral occlusion sensing of claim 4 , wherein the predetermined metric further comprises a selected time duration that is shorter than an average value of the pump measurements that comprise the time duration when no occlusion is occurring in the pump.

6. The infusion device with integral occlusion sensing of claim 1 , wherein the pump measurement device comprises an end-stop switch on the pump configured to be activated when the pumping mechanism completes at least one of the aspirate stroke of each pump cycle among the plurality of pump cycles and the dispense stroke of each pump cycle among the plurality of pump cycles, the end-stop switch being connected to the processing device to determine a time duration related to each of the at least one of the aspirate stroke of each pump cycle among the plurality of pump cycles and the dispense stroke of each pump cycle among the plurality of pump cycles.

7. The infusion device with integral occlusion sensing of claim 6 , wherein the pump measurements further comprise a duration of end-stop switch activation that corresponds to the time duration related to each of the at least one of the aspirate stroke of each pump cycle among the plurality of pump cycles and the dispense stroke of each pump cycle among the plurality of pump cycles, and the predetermined metric further comprises a selected time duration for the end-stop switch activation that is longer than an average value of the pump measurements that comprise the time duration related to each of the at least one of the aspirate stroke of each pump cycle among the plurality of pump cycles and the dispense stroke of each pump cycle among the plurality of pump cycles when no occlusion is occurring in the pump.

8. The infusion device with integral occlusion sensing of claim 1 , wherein the processing device is configured to determine, for each of the plurality of pump cycles, an average pumping mechanism current of the aspirate stroke, an average pumping mechanism current of the dispense stroke, and a difference between the average pumping mechanism current of the dispense stroke and the average pumping mechanism current of the aspirate stroke, and the predetermined metric further comprises a designated value for the difference between the average pumping mechanism current of the dispense stroke and the average pumping mechanism current of the aspirate stroke that, when exceeded, indicates the occlusion.

9. The infusion device with integral occlusion sensing of claim 8 ,
wherein the pump measurement device comprises an end-stop switch on the pump configured to be activated when the pumping mechanism completes at least one of the aspirate stroke of each pump cycle among the plurality of pump cycles and the dispense stroke of each pump cycle among the plurality of pump cycles, the end-stop switch being connected to the processing device to determine a time duration related to each of the at least one of the aspirate stroke of each pump cycle among the plurality of pump cycles and the dispense stroke of each pump cycle among the plurality of pump cycles, such that the pump measurements further comprise a duration of end-stop switch activation that corresponds to the time duration related to each of the at least one of the aspirate stroke of each pump cycle among the plurality of pump cycles and the dispense stroke of each pump cycle among the plurality of pump cycles, the predetermined metric further comprises a selected time duration for the end-stop switch activation that is longer than an average value of the pump measurements that comprise the time duration related to each of the at least one of the aspirate stroke of each pump cycle among the plurality of pump cycles and the dispense stroke of each pump cycle among the plurality of pump cycles when no occlusion is occurring in the pump;
wherein the pump measurements comprise at least two of: the duration of the end-stop switch activation, the time duration related to each of the at least one of the aspirate stroke of each pump cycle among the plurality of pump cycles and the dispense stroke of each pump cycle among the plurality of pump cycles, a time difference between the at least one of the aspirate stroke of each pump cycle among the plurality of pump cycles and the dispense stroke of each pump cycle among the plurality of pump cycles, and the difference between the average pumping mechanism current of the dispense stroke and the average pumping mechanism current of the aspirate stroke; and
wherein the predetermined metric further comprises predetermined metrics that correspond to respective ones of the at least two of the pump measurements, the predetermined metrics comprising the selected time duration for the end-stop switch activati

Assignees

• Becton Dickinson Co

Inventors

• Zheng Ling
• Kashef Mojtaba
• Siddiqui Uzair
• Li Jinyan
• Sun Kepei
• Iskandar Joseph
• Gurin Elizabeth

Classifications

• A61M2205/3331

  Pressure; Flow · CPC title

• A61M2205/18

  with alarm · CPC title

• A61M2005/16863

  Occlusion detection · CPC title

• A61M2005/14208

  with a programmable infusion control system, characterised by the infusion program · CPC title

• A61M5/14212 Primary

  Pumping with an aspiration and an expulsion action · CPC title