Methods, circuits, devices, apparatuses, encasements and systems for identifying if a medical infusion system is decalibrated

• US 9,726,167 B2
• Filed: 06/21/2012
• Issued: 08/08/2017
• Est. Priority Date: 06/27/2011
• Status: Active Grant

• Current Assignee: Eitan Medical Limited
• Original Assignee: Q Core Medical Ltd.
• Inventors: Eitan, Boaz, Schweitzer, Nimrod, Yosef, Andrei, Eitan, Shaul, Ofer, Meged, Sayag, Shalom
• Primary Examiner(s): Gray, David M
• Assistant Examiner(s): Evans, Geoffrey T
• Application Number:
  US14/126,852
• Publication Number:
  US 20140119954A1
• Time in Patent Office: 1,874 Days
• Field of Search: 702100
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3351 Controlling upstream pump pressure
• CPC Class Codes: A61M 2205/3355 Controlling downstream pump pressure
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/70 with testing or calibration facilities
• CPC Class Codes: A61M 2209/02 Equipment for testing the apparatus
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/365 Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626
• CPC Class Codes: F04B 49/00 Control , e.g. of pump delivery, or pump pressure of, or safety measures for, machines, pumps, or pumping installations, not otherwise provided for, or of interest apart from, groups F04B1/00 - F04B47/00

Abstract

Disclosed is an infusion pump which may include a native pumping mechanism to drive fluids through a functionally associated conduit, at least one native sensor to sense a physical characteristic of the fluid within the conduit and computing circuitry having a decalibration test mode to determine whether the infusion pump is decalibrated. The computing circuitry may be adapted to receive output from at least one native sensor during the decalibration test mode.

Claims

1. An infusion pump having a decalibration test mode to determine whether the infusion pump is decalibrated, said pump comprising:

a native pumping mechanism to drive fluids through a functionally associated conduit at a predetermined first flow rate;

at least one native sensor to sense a physical characteristic of the fluid within the conduit including a pressure sensor to sense a level of pressure of the fluid within the conduit and during said decalibration test mode to relay an indicator that a container, having a known volume connected to an output of said pumping mechanism, is full; and

computing circuitry (a) to receive said indicator from said pressure sensor, (b) in response to receiving said indicator, to calculate an average flow rate at least partially based on said indicator and (c) to determine whether the infusion pump is decalibrated based on a comparison of said average flow rate with said predetermined first flow rate.

2. The infusion pump according to claim 1, further comprising an external interface for a decalibration testing device, which decalibration testing device does the comparison of the output to an expected decalibration test parameter.

3. The infusion pump according to claim 1, wherein said at least one native sensor further comprises a bubble detector.

4. The infusion pump according to claim 1, wherein said at least one native sensor further comprises a second sensor selected from the group consisting of:

an accelerometer, a temperature sensor, an altitude sensor and a flow meter.

5. The infusion pump according to claim 1, wherein said native sensor is configured to detect that a predefined volume of fluid has passed through said native pumping mechanism.

6. The infusion pump according to claim 1, wherein said native pumping mechanism is classified by a unique identification and said computing circuitry is configured to store said unique identification and said decalibration testing result.

7. The infusion pump according to claim 1, further comprising a counter to relay a cycle number associated with said pumping mechanism and wherein said computing circuitry calculates said estimated flow rate based on said cycle number and the known volume.

8. An infusion pump decalibration testing system, comprising:

a pumping mechanism to drive fluids through a functionally associated conduit at a predetermined first flow rate;

at least one sensor to sense a physical characteristic of the fluid within the conduit, including a pressure sensor to sense a level of pressure of the fluid within the conduit and during a decalibration test mode to relay an indicator that a container, having a known volume connected to an output of said pumping mechanism, is full;

computing circuitry having a decalibration test mode (a) to receive said indicator from said pressure sensor during the decalibration test mode, (b) in response to receiving said indicator, to calculate an average flow rate at least partially based on said indicator and (c) to determine whether the infusion pump is decalibrated based on a comparison of said average flow rate with said predetermined first flow rate; and

ancillary circuitry to activate a predetermined state on said pumping mechanism including said container.

9. The testing system of claim 8, wherein said predetermined state is selected from the group consisting of:

inserting air above a predefined threshold within said pumping mechanism, external pressure on said pumping mechanism.

10. The system according to claim 8, wherein said at least one sensor includes a bubble detector.

11. The system according to claim 8, wherein said ancillary circuitry further comprises a syringe, a check valve and a predefined line-marked conduit.

12. The system according to claim 8 wherein said ancillary circuitry is a container having a known volume capacity, wherein said container is connectable to said conduit and a valve.

13. The testing system of claim 8, further comprising a counter to relay a cycle number associated with said pumping mechanism and wherein said computing circuitry calculates said estimated flow rate based on said cycle number and the known volume.