PORTABLE INFUSION MANAGEMENT APPARATUS AND METHOD

• US 20120041413A1
• Filed: 08/11/2011
• Published: 02/16/2012
• Est. Priority Date: 08/11/2010
• Status: Active Grant

• Current Assignee: Fresenius KABI USA LLC (Fresenius SE & Co. KGaA)
• Original Assignee: Fluidnet Corporation (Fresenius SE & Co. KGaA)
• Inventors: Carlisle, Jeffrey A., Powers, Benjamin G.
• Granted Patent: US 8,876,756 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 5/155 pressurised by gas introduced into the reservoir
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28

Abstract

A portable infusion apparatus and method are provided for controlling the delivery of medicinal fluid to a patient.

Claims

1. A portable system for the controlled delivery of medicinal fluid, the system comprising:

a pressure frame;

an inflatable bladder within said pressure frame;

said pressure frame adapted to receive a flexible bag containing a liquid to be infused, said inflatable bladder for exerting a force on the flexible bag;

a calibration tank of known volume;

a pump fluidically coupled to said bladder and said calibration tank for selectively delivering a gas to said bladder and said calibration tank;

one or more valves which may be selectively opened or closed to selectively isolate or combine said bladder volume and said calibration tank volume;

one or more pressure sensors for one or both of sensing the pressure of a gas in said calibration tank and sensing the pressure of a gas in said bladder;

a temperature sensor providing a signal indicating the temperature of the system;

a processing unit coupled to said one or more pressure sensors for receiving pressure information from said one or more pressure sensors and coupled to said temperature sensor for receiving said signal indicating the temperature of the system;

said processing unit further coupled to said pump and said one or more valves, said processing unit for controlling said pump and said valve means; and

said processing unit further comprising control logic for calculating a rate of flow of fluid exiting the flexible container.

2. The system of claim 1, further comprising:

an input device for inputting a desired flow rate to said processing unit;

said processing unit including control logic for adjusting the pressure of the gas in said bladder so that the rate of flow of fluid exiting the flexible container matches the desired flow rate.

3. The system of claim 2, further comprising:

a flow path including a variable flow resistor fluidically coupled to the flexible bag, wherein the input device for inputting a desired flow rate also adjusts the variable flow resistor to a setting appropriate for the desired flow rate.

4. The system of claim 1, wherein said pressure frame is adjustable to receive flexible bags of a plurality of sizes.

5. The system of claim 2, wherein operation of the input device to input the desired flow rate simultaneously adjusts a variable flow resistor to an appropriate setting for the desired flow rate.

6. The system of claim 5, wherein the input device for inputting the desired flow rate is operated by twisting a portion of the input device.

7. The system of claim 6, wherein said input device includes a rotatable actuator coupled to a variable flow resistor and a potentiometer.

8. The system of claim 1, wherein the system is battery powered.

9. The system of claim 2, further comprising a display for displaying the desired flow rate in human viewable form.

16. The system of claim 8, further comprising a rotatable actuator interfacing with said input device for inputting the desired flow rate and interfacing with a rotatable adjustment mechanism on the variable fluid flow rate resistor, wherein twisting the rotatable actuator simultaneously inputs the desired flow rate and adjusts the variable fluid flow resistor.

10. A portable system for the controlled delivery of medicinal fluid, the system comprising:

a fluid pathway assembly defining a fluid pathway and including a fluid source in a flexible bag and a variable fluid flow resistor;

a flow control device removably attached to said fluid pathway and interfacing with said variable fluid flow resistor;

said flow control device including a power source;

said flow control device further including an enclosure enclosing said fluid source, said enclosure including an adjustable structural element and an inflatable bladder;

said flow control device further including an input device for inputting a desired flow rate and actuator for adjusting the variable fluid flow resistor;

said flow control device further including a calibration chamber of known volume, a source of pressurized gas to selectively pressurize either or both of said calibration chamber and said bladder, and one or more pressure sensors for measuring the pressure in said calibration chamber and said bladder;

said flow control device further including one or more valves to fluidically couple, isolate and/or vent said calibration chamber, said bladder, or both;

said flow control device further including a processor connected to said source of pressurized gas, said one or more pressure sensors, said one or more valves, and said input device; and

said processor including control logic for calculating an actual flow rate of fluid from said fluid source and adjusting the pressure in said bladder so that the actual flow rate matches the desired flow rate.

11. The system of claim 10, wherein the source of pressurized gas is a pump.

12. The system of claim 10, wherein said enclosure of said fluid source is sized to accommodate flexible bags of a plurality of sizes.

13. The system of claim 10, wherein said adjustable structural element of said enclosure of said fluid is formed of a material selected from woven fabric and plastic film, or a combination thereof.

14. The system of claim 13, wherein the enclosure includes one or more fasteners selected from hook and loop fasteners, post and eye fasteners, snaps, or any combination thereof.

15. The system of claim 10, wherein the enclosure includes one or more fasteners selected from hook and loop fasteners, post and eye fasteners, snaps, or any combination thereof.

17. The system of claim 10, wherein the power source is batteries.

18. A method for delivering fluid to a patient, the method comprising:

providing a flexible bag containing a fluid to be delivered;

connecting a fluid pathway to the flexible bag, the fluid pathway including a variable fluid flow resistor;

providing a control device with a calibration chamber of known volume, a pressurizable cuff and an interface to the variable flow resistor;

placing the flexible bag in the pressurizable cuff, inserting the variable flow resistor into the interface to the variable flow resistor, and setting a desired flow rate of the fluid to be delivered;

pressurizing the cuff to an initial pressure and measuring the pressure in the cuff;

pressurizing the calibration chamber to a higher initial pressure and measuring the pressure in the calibration chamber;

fluidly coupling the calibration chamber to the pressurized cuff and measuring the resulting pressure;

calculating the volume of gas in the cuff;

monitoring the pressure decay in the cuff and calculating an actual flow rate of the fluid;

if the actual flow rate is greater than the desired flow rate, decreasing the pressure in the cuff until the actual flow rate equals the desired flow rate; and

if the calculated flow rate is less than the desired flow rate, increasing the pressure in the cuff until the calculated flow rate equals the desired flow rate.

19. The method of claim 20, wherein setting the desired flow rate also adjusts the variable flow resistor to a setting appropriate to the desired flow rate.