INFUSION SYSTEM WITH CONCURRENT TPN/INSULIN INFUSION

• US 20160175517A1
• Filed: 12/17/2015
• Published: 06/23/2016
• Est. Priority Date: 12/19/2014
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: Hospira Incorporated (Pfizer Inc.)
• Inventors: Sileika, Tadas S., Schmidt, Justin J., Brown, James B., Day, William Kenneth
• Granted Patent: US 11,344,668 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 9/0029 Parenteral nutrition; Parenteral nutrition compositions as drug carriers
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

An infusion system to provide concurrent TPN/insulin infusion including: a fluid administration set having a primary line in fluid communication with the TPN source, a secondary line in fluid communication with the insulin source, and a common outlet line; a pump operable to removably receive the fluid administration set, the pump being operable to concurrently move the TPN solution through the primary line in response to a TPN solution flow rate signal and the insulin solution through the secondary line in response to an insulin solution flow rate signal; and a flow controller operable to provide the TPN solution flow rate signal and the insulin solution flow rate signal to the pump. The flow controller is further operable to vary the TPN solution flow rate signal and the insulin solution flow rate signal to vary a ratio of TPN solution to insulin solution provided to the common outlet line.

Claims

1. An infusion system for use with a TPN source of TPN solution and an insulin source of insulin solution to provide concurrent TPN/insulin infusion, the infusion system comprising:

a fluid administration set having a primary line in fluid communication with the TPN source, a secondary line in fluid communication with the insulin source, and a common outlet line connected to and in operative fluid communication with the primary line and the secondary line;

a positive displacement pump operable to removably receive the fluid administration set, the pump having a drive mechanism being operable on the fluid administration set to concurrently move the TPN solution through the primary line to the outlet line in response to a TPN solution flow rate signal and the insulin solution through the secondary line to the outlet line in response to an insulin solution flow rate signal; and

a flow controller operable to provide the TPN solution flow rate signal and the insulin solution flow rate signal to the drive mechanism of the pump,

wherein the flow controller is further operable to vary the TPN solution flow rate signal and the insulin solution flow rate signal to vary a ratio of TPN solution to insulin solution provided to the common outlet.

2. The infusion system of claim 1 wherein the flow controller is further operable to ramp the TPN solution flow rate signal from a value corresponding to a TPN dose rate of zero to a value corresponding to a continuous phase TPN dose rate over a user selectable duration in a TPN ramp phase.

3. The infusion system of claim 2 wherein the flow controller is further operable to maintain the insulin solution flow rate signal at a value corresponding to an insulin dose rate of zero during the TPN ramp phase.

4. The infusion system of claim 2 wherein the flow controller is further operable to maintain the insulin solution flow rate signal as a selected fraction of the TPN solution flow rate signal during the TPN ramp phase.

5. The infusion system of claim 2 wherein the flow controller is further operable to maintain the insulin solution flow rate signal at a value corresponding to a continuous phase insulin dose rate during the TPN ramp phase.

6. The infusion system of claim 1 wherein the flow controller is further operable to maintain the TPN solution flow rate signal at a value corresponding to a continuous phase TPN dose rate and to maintain the insulin solution flow rate signal at a selected fraction of the TPN solution flow rate signal during the TPN continuous phase.

7. The infusion system of claim 1 wherein the flow controller is further operable to taper the TPN solution flow rate signal over a user selectable duration from a value corresponding to a continuous phase TPN dose rate to a value corresponding to a TPN dose rate of zero during a TPN taper phase.

8. The infusion system of claim 7 wherein the flow controller is further operable to maintain the insulin solution flow rate signal at a value corresponding to an insulin dose rate of zero during the TPN taper phase.

9. The infusion system of claim 7 wherein the flow controller is further operable to maintain the insulin solution flow rate signal as a selected fraction of the TPN solution flow rate signal to maintain the ratio of the TPN solution to the insulin solution constant during the TPN taper phase.

10. The infusion system of claim 7 wherein the flow controller is further operable to maintain the insulin solution flow rate signal at a value corresponding to a continuous phase insulin dose rate during the TPN taper phase.

11. The infusion system of claim 1 wherein the flow controller is further operable to decrease the TPN solution flow rate signal over a user selectable duration from a value corresponding to a continuous phase TPN dose rate to a value corresponding to a Keep Vein Open (KVO) TPN dose rate after a TPN continuous phase.

12. The infusion system of claim 1 wherein the flow controller is further operable to vary the insulin solution flow rate signal from a first insulin solution flow rate signal to a second insulin solution flow rate signal in response to input of the second insulin solution flow rate signal by a user.

13. The infusion system of claim 1 further comprising a glucose sensor operably connected to the patient to monitor glucose level and to provide a glucose signal to the flow controller, wherein the flow controller is further operable to vary the insulin solution flow rate signal from a first insulin solution flow rate signal to a second insulin solution flow rate signal in response to the glucose signal.

14. The infusion system of claim 1 further comprising a user interface operably connected to the flow controller, the user interface being operable to display a TPN/Insulin Infusion Plot portion having a TPN Infusion profile and an Insulin Infusion profile.

15. The infusion system of claim 14 wherein the user interface is further operable to display an Infusion Progression indicator on the TPN/Insulin Infusion Plot portion, the Infusion Progression indicator being operable to indicate a current state of the concurrent TPN/insulin infusion.

16. The infusion system of claim 14 wherein the user interface is further operable to display an infusion portion selected from the group consisting of a Ramp portion, a Continuous portion, a Taper portion, and a KVO portion.

17. The infusion system of claim 1 wherein the administration set comprises a cassette including a primary inlet joining a primary fluid passageway into fluid communication with the primary line, a secondary inlet joining a secondary fluid passageway into fluid communication with the secondary line, an outlet in fluid communication with the outlet line, and a pumping/mixing chamber covered by a resilient flexible membrane and in fluid communication with the primary fluid passageway, the secondary fluid passageway and the outlet.

18. The infusion system of claim 17 wherein the drive mechanism comprises a motor driving a plunger into the membrane covering the pumping/mixing chamber while operating a primary inlet valve, a secondary inlet valve and an outlet valve so as to mix and displace fluid from the pumping/mixing chamber through the outlet into the outlet line.

19. A method to concurrently deliver a TPN solution from a TPN source container and an insulin solution from an insulin source container that is separate from the TPN source container, the method comprising:

providing a fluid administration set having a primary line, a secondary line, a common outlet line, and a pumping/mixing chamber located between and in fluid communication with the primary line, the secondary line and the common outlet line;

connecting the primary line to the TPN source container;

connecting the secondary line to the insulin source container;

selectively allowing the primary line to feed TPN solution from the primary line to the pumping/mixing chamber;

selectively allowing the secondary line to feed insulin solution to the pumping/mixing chamber;

mixing the TPN solution and the insulin solution in the pumping/mixing chamber to generate an infusion mixture before the common outlet line;

driving with a positive displacement pumping mechanism the TPN solution from the pumping/mixing chamber through the common outlet line at a TPN dose rate; and

concurrently with said driving the TPN solution,

driving with the positive displacement pumping mechanism the insulin solution from the mixing chamber through the common outlet line at an insulin dose rate;

varying at least one of the TPN dose rate and the insulin dose rate to vary a ratio of TPN solution to insulin solution in the infusion mixture.

20. The method of claim 19 wherein the varying comprises ramping the TPN dose rate from zero to a continuous phase TPN dose rate during a user selectable duration.

21. The method of claim 19 wherein the varying comprises maintaining the TPN dose rate at a continuous phase TPN dose rate and maintaining the insulin dose rate at a selected fraction of the continuous phase TPN dose rate.

22. The method of claim 19 wherein the varying comprises tapering the TPN dose rate from a continuous phase TPN dose rate to a TPN dose rate of zero during a user selectable duration.

23. The method of claim 19 wherein the varying comprises decreasing the TPN dose rate from a continuous phase TPN dose rate to a Keep Vein Open (KVO) TPN dose rate during a user selectable duration.

24. The method of claim 19 wherein the insulin dose rate is a first insulin dose rate and the method further comprises driving the insulin solution at a second insulin dose rate in response to input of the second insulin dose rate by a user.

25. The method of claim 19 further comprising monitoring glucose level in the patient and adjusting the insulin dose rate in response to the monitored glucose level.

26. The method of claim 19 further comprising displaying planned values of the TPN dose rate and the insulin dose rate as a function of time on a TPN/Insulin Infusion Plot, and displaying an Infusion Progression indicator at a present infusion time on the TPN/Insulin Infusion Plot.