Methods, Circuits, Devices, Apparatuses, Encasements and Systems for Identifying if a Medical Infusion System is Decalibrated

• US 20140119954A1
• Filed: 06/21/2012
• Published: 05/01/2014
• Est. Priority Date: 06/27/2011
• Status: Active Grant

• Current Assignee: Eitan Medical Limited
• Original Assignee: Q Core Medical Ltd.
• Inventors: Eitan, Boaz, Eitan, Shaul, Ofer, Meged, Schweitzer, Nimrod, Yosef, Andrei, Sayag, Shalom
• Granted Patent: US 9,726,167 B2
• Time in Patent Office: Days
• US Class Current: 417/63
• 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 comprising:

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, wherein said computing circuitry is adapted to receive output from said at least one native sensor during said decalibration test mode.

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 2, wherein said comparison is used to compute a decalibration testing result.

4. The infusion pump according to claim 1 wherein said native sensor is a pressure sensor

5. The infusion pump according to claim 1, wherein said native sensor is a bubble detector.

6. The infusion pump according to claim 1, wherein said native sensor is selected from the group consisting of:

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

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

8. 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.

9. An infusion pump decalibration testing system, comprising:

a pumping mechanism to drive fluids through a functionally associated conduit;

at least one sensor to sense a physical characteristic of the fluid within the conduit;

computing circuitry having a decalibration test mode and adapted to receive output from said at least one native sensor during the decalibration testing and compare said output to a predefined decalibration range; and

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

10. The testing system of claim 9, 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.

11. The system according to claim 9 wherein said sensor is a pressure sensor

12. The system according to claim 9, wherein said sensor is a bubble detector.

13. The system according to claim 9, wherein said predefined decalibration range is selected from the group consisting of:

a look-up table of differences in pressure, expected flow rate and detection of bubbles.

14. The system according to claim 9, wherein said ancillary circuitry further comprises a syringe, a check valve and a predefined line-marked conduit.

15. The system according to claim 9 wherein said ancillary circuitry is a container having a known volume capacity, wherein said container is connectable to said conduit and a valve.

16. Software for carrying out decalibration testing on an infusion pump, said software, comprising:

computer executable code to;

(a) at least partially automatically activate a pumping mechanism and (b) receive an output from the pumping mechanism associated with a pumping mechanism native sensor;

computing circuitry to compare said output with a predefined expected decalibration test parameter and to determine a decalibration test result.

17. The software according to claim 16, wherein said output is a termination signal indicating that a predetermined amount of fluid has passed through the pumping mechanism and wherein said code is further configured to receive a cycle number from a counter associated with said pumping mechanism and to calculate an estimated flow rate.

18. The software according to claim 17, wherein said cycle number is selected from the group consisting of:

number of pumping mechanism cycles completed, number of drops emitted by pumping mechanism and length of active time of pumping mechanism.

19. The software according to claim 16, wherein said output is two or more sensed pressure values and said predefined expected decalibration test parameter is a lookup table of expected differences in pressure values.

20. The software according to claim 16, wherein said output indicates if an air bubble was detected and said test parameter is an air bubble detection expected result.