Granted Patent B2

US 12,251,544 · App. 17/048,219 · Granted Mar 18, 2025

Inventors: Michael McDermott (Pittsburgh, PA); William Barone (Pittsburgh, PA); Barry Iddon (Jeannette, PA); John Volkar (Valencia, PA)

Assignee: BAYER HEALTHCARE LLC

A61M5/365A61M5/007A61M5/3146A61M5/14546A61M2205/3379A61M2205/3386A61M2205/50A61M2205/502

Abstract

Claims (35)

1. An injector system for delivering a medical fluid, comprising:

at least one syringe defining a reservoir operatively connected to a piston, the at least one syringe comprising a plunger and at least one port in fluid communication with the reservoir, the reservoir configured to contain the medical fluid; and

at least one processor programmed or configured to:

based on an air check protocol for detecting air in the reservoir, determine a baseline value comprising baseline compressibility data for the at least one syringe of the injector system, wherein the reservoir is substantially filled with a first amount of the medical fluid and a known volume of air;

deliver the first amount of the medical fluid from the reservoir;

refill the reservoir with a second amount of the medical fluid;

based on the air check protocol, perform an air check pressurization sequence by gathering air check compressibility data for the at least one syringe of the injector system; and

based on the air check protocol, compare the air check compressibility data with the baseline compressibility data to determine a volume of air present in the reservoir

wherein the processor is further programmed or configured to, based on the air check protocol, incorporate a correction factor when comparing the air check compressibility data with the baseline compressibility data to account for variations in at least one of deflection of one or more injector system components, different volumes of the medical fluid compared to the volume of the first amount of the medical fluid used for determining the baseline compressibility data, and different positions of the piston compared to a position of the piston when determining the baseline compressibility data.

2. The injector system of claim 1 , wherein the baseline value is determined to account for a deflection of one or more components of the injector system and compliance of the reservoir and a fluid path, and a compressibility of the known volume of air.

3. The injector system of claim 1 , wherein the processor is further programmed or configured to, based on the air check protocol, purge any air in the first amount of the medical fluid from the reservoir before determining the baseline value.

4. The injector system of claim 1 , wherein the processor is further programmed or configured to, based on the air check protocol, deliver a prime volume of the second amount of the medical fluid from the reservoir, wherein the prime volume of the second amount of the medical fluid has a volume greater than the volume of air present in the reservoir.

5. The injector system of claim 4 , wherein the further programming or configuring the processor to deliver the prime volume of the second amount of the medical fluid further comprises optimizing the prime volume equal to a minimum volume of the second amount of the medical fluid necessary to remove the volume of air present in the reservoir.

6. The injector system of claim 4 , further comprising a downstream air detector, wherein the downstream air detector is programmed or configured to confirm that no further air is present in a fluid path after the prime volume of the second amount of medical fluid as it is delivered from the reservoir.

7. The injector system of claim 1 , wherein the processor is further programmed or configured to, based on the air check protocol, determine whether the volume of air present in the reservoir exceeds a predetermined volume value.

8. The injector system of claim 7 , wherein, in the event the volume of air in the reservoir exceeds the predetermined volume value, the processor is further programmed or configured to, based on the air check protocol, purge the volume of air from the reservoir before the second amount of the medical fluid is delivered from the reservoir or determine whether a fault condition exists.

9. The injector system of claim 8 , wherein, after the volume of air has been purged from the reservoir, the processor is further programmed or configured to, based on the air check protocol, perform an additional air check pressurization sequence by gathering additional air check compressibility data from the reservoir, and compare the additional air check compressibility data with the baseline compressibility data to determine whether any air remains in the reservoir.

10. The injector system of claim 7 , wherein the predetermined volume value ranges from 0.1 milliliters to 20 milliliters.

11. The injector system of claim 1 , wherein comparing the air check compressibility data with the baseline compressibility data to determine the volume of air present in the reservoir comprises using an embedded algorithm to compare the air check compressibility data with the baseline compressibility data to determine the volume of air present in the reservoir.

12. The injector system of claim 1 , wherein the at least one syringe further includes at least one valve associated with the at least one port, the at least one valve is configured to move between a fill position, a delivery position, and a closed position in response to one or more instruction from the at least one processor.

13. The injector system of claim 12 , wherein the at least one valve is in the closed position for at least one of determining the baseline compressibility data and performing the air check pressurization sequence.

14. A method for detecting air in at least one reservoir of a fluid injector system, the method comprising:

determining a baseline value comprising baseline compressibility data for the at least one reservoir of the fluid injector system, the at least one reservoir having at least one port, wherein the at least one reservoir is substantially filled with a first amount of a medical fluid and a known amount of air;

delivering the first amount of the medical fluid from the at least one reservoir;

refilling the at least one reservoir with a second amount of the medical fluid;

performing an air check pressurization sequence comprising pressurizing the medical fluid in the at least one reservoir and gathering air check compressibility data;

comparing the air check compressibility data with the baseline compressibility data to determine a volume of air present in the at least one reservoir; and

incorporating a correction factor when comparing the air check compressibility data with the baseline compressibility data to account for variations in at least one of deflection of one or more fluid injector system components, different volumes of the medical fluid compared to the volume of the first amount of the medical fluid used for determining the baseline compressibility data, and different positions of a piston in the fluid injector system compared to a position of the piston when determining the baseline compressibility data.

15. The method of claim 14 , wherein determining the baseline value comprises accounting for a deflection of the fluid injection system, compliance of the at least one reservoir and a fluid path, and a compressibility of the known volume of air.

16. The method of claim 14 , further comprising purging the known volume of air from the at least one reservoir prior to determining the baseline value.

17. The method of claim 14 , further comprising delivering a prime volume of the second amount of the medical fluid from the at least one reservoir, wherein the prime volume of the second amount of the medical fluid has a volume greater than the volume of the air present in the at least one reservoir.

18. The method of claim 17 , wherein delivering the prime volume of the second amount of the medical fluid further comprises optimizing the prime volume to equal to a minimum volume of the second amount of the medical fluid necessary to remove the volume of the air present in the at least one reservoir.

19. The method of claim 14 , further comprising determining whether a fault condition exists when the volume of air present in the at least one reservoir exceeds a predetermined volume value.

20. The method of claim 14 , further comprising closing a fluid path associated with the at least one port of the at least one reservoir prior to at least one of determining the baseline value and performing the air check pressurization sequence.

21. The method of claim 14 , wherein the second amount of the medical fluid is different than the first amount of the medical fluid.

Assignments (1)

Continuity (3)

References Cited (400)