Pump engine with metering system for dispensing liquid medication

• US 9,867,929 B2
• Filed: 08/09/2013
• Issued: 01/16/2018
• Est. Priority Date: 08/15/2012
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Searle, Gary, Tunkel, Roman, Tormey, III, William, Leonczyk, Andrew, Pollock, David, Naumann, Paul, Focht, Kenneth
• Primary Examiner(s): Hayman, Imani
• Assistant Examiner(s): Engel, Matthew A
• Application Number:
  US13/963,748
• Publication Number:
  US 20140052096A1
• Time in Patent Office: 1,621 Days
• Field of Search: 604 9, 604 67, 604506, 604 32, 604256, 604248, 604181-183, 604167, 604151
• CPC Class Codes: A61M 2005/16863 Occlusion detection
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/16809 by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28
• CPC Class Codes: F04C 2270/041 Controlled or regulated

Abstract

An infusion pump system is disclosed for dispensing liquid medication, such as insulin. The infusion pump system includes a first reservoir for storing liquid medication, a first fluid driver for exerting pressure on the first reservoir, a second reservoir for storing liquid medication, and a second fluid driver for exerting pressure on the second reservoir. One or more valves are used to permit flow of liquid medication from the first reservoir to the second reservoir, and to permit flow of liquid medication from the second reservoir to an infusion site. Each of the valves is selectively opened or closed to fill the second reservoir with liquid medication from the first reservoir and to dispense liquid medication from the second reservoir to the infusion site. A controller and one or more sensors are used to monitor and control the system.

Claims

1. An infusion pump system for dispensing a liquid medication, comprising:

a first reservoir having a first cross-sectional area for storing the liquid medication and a pump engine for moving a plunger within the first cross-sectional area;

a second reservoir having a second cross-sectional area smaller than the first cross-sectional area, and a fluid driver for moving a plunger within the second cross-sectional area of the second reservoir for storing the liquid medication received from the first reservoir;

a first valve configured to control the flow of the liquid medication from the first reservoir to the second reservoir allowing the fluid to move from the first reservoir to the second reservoir and increase the volume of the second reservoir to receive the liquid medication from the first reservoir;

a second valve configured to control the flow of the liquid medication from the second reservoir to an infusion site when fluid driver drives fluid from the second reservoir;

wherein the first valve is selectively opened or closed to admit the liquid medication from the first reservoir to the second reservoir; and

wherein the second valve is selectively opened or closed to dispense the liquid medication from the second reservoir to the infusion site.

2. The infusion pump system as claimed in claim 1, further comprising a third valve for controlling the flow rate of the liquid medication to the infusion site.

3. The infusion pump system as claimed in claim 2, wherein the third valve comprises an adjustable flow valve comprising an adjustable orifice through which the liquid medication flows to the infusion site.

4. The infusion pump system as claimed in claim 2, further comprising a Micro Electro Mechanical Systems (MEMS) chip unit comprising the first valve, the second valve and the third valve.

5. The infusion pump system, as claimed in claim 2, further comprising:

a first sensor for sensing and monitoring fluid line pressure to inform a controller when the second reservoir is filled to an acceptable level, the controller stopping the first fluid driver when the second reservoir reaches the acceptable level.

6. The infusion pump system as claimed in claim 5, wherein the first sensor comprises a pressure sensor.

7. The infusion pump system as claimed in claim 5, wherein the first sensor is configured to:

detect pressure decay;

determine where a leak in the fluidic system exists by opening one or more of the first, the second, and the third the valves individually;

determine the fill state of the first or second reservoirs; and

/or

determine if partial or complete occlusion exists in the system.

8. The infusion pump system as claimed in claim 2, further comprising:

a second sensor for informing a controller when the amount of the liquid medication in the second reservoir is at a low or acceptable level, the controller activating the first fluid driver to fill the second reservoir when the amount of the liquid medication in the second reservoir is at a low or acceptable level and stopping the first fluid driver when the second reservoir reaches the acceptable level.

9. The infusion pump system as claimed in claim 8, wherein the second sensor comprises a position sensor configured to detect the position of a plunger in the second reservoir.

10. The infusion pump system as claimed in claim 2, wherein incremental dosing of the liquid medication from the second reservoir to the infusion site occurs when the first valve is closed, the second valve is open, and the third valve is controlling the flow rate of the liquid medication to the infusion site.

11. The infusion pump system, as claimed in claim 2, wherein the first valve comprises a flow control valve.

12. The infusion pump system, as claimed in claim 2 further comprising:

one or more sensors for detecting occlusion or back pressure within the infusion pump system;

one or more sensors for detecting presence of bubbles in a delivery line of the infusion pump system;

one or more sensors for detecting a fill status of the secondary reservoir of the infusion pump system;

one or more sensors for detecting leakage in the infusion pump system; and

/or

one or more sensors for measuring a flow rate of the liquid medication in the infusion pump system.

13. The infusion pump system as claimed in claim 2, wherein the second reservoir, the fluid driver, the first valve, the second valve, and associated fluid connectors comprise a metering system.

14. The infusion pump system as claimed in claim 2, further comprising:

a second sensor for sensing and monitoring fluid line pressure between the first reservoir and the second reservoir and informing a controller when the second reservoir is filled to an acceptable level, the controller stopping the at least one fluid driver from exerting pressure on the first reservoir when the second reservoir reaches the acceptable threshold.

15. The infusion pump system as claimed in claim 2, wherein the first valve and the second valve each comprise a flow control valve.

16. The infusion pump system as claimed in claim 2, further comprising:

a plurality of pressure sensors connected to the second reservoir to provide feedback on the fill status of the second reservoir, to detect occlusion in the infusion pump system, to detect back pressure in the infusion pump system, and/or to detect a flow rate of the liquid medication into the infusion site.

17. The infusion pump system as claimed in claim 2, further comprising a Micro Electro Mechanical Systems (MEMS) chip comprising at least one of the first, second and third valves.

18. The infusion pump system as claimed in claim 17, wherein the MEMS chip further comprises the second reservoir.

19. The infusion pump system as claimed in claim 17, further wherein the MEMS chip further comprises the first sensor.

20. The infusion pump system as claimed in claim 1, wherein the first valve comprises a check valve, and the second valve comprises a directional control valve.

21. The infusion pump system, as claimed in claim 1, wherein the second reservoir, the fluid driver, the first valve, the second valve, the third valve and one or more fluid connectors comprise a metering system.

22. The infusion pump system as claimed in claim 1, wherein the first reservoir comprises a syringe-type reservoir.

23. The infusion pump system as claimed in claim 1, wherein the maximum storage capacity for the liquid medication in the second reservoir is a safe or less than harmful dose to a user.

24. The infusion pump system as claimed in claim 1, wherein the maximum storage capacity of the liquid medication in the first reservoir is greater than that of the second reservoir.

25. The infusion pump system as claimed in claim 1, wherein at least one of the first and second valves is controlled by applying electrical potentials.