System and method for controlling administration of medical fluid

• US 20070255199A1
• Filed: 05/01/2006
• Published: 11/01/2007
• Est. Priority Date: 05/01/2006
• Status: Active Grant

• Current Assignee: Carefusion 303 Incorporated (Becton, Dickinson & Co)
• Original Assignee: Cardinal Health 303 Incorporated (Cardinal Health, Inc.)
• Inventors: Dewey, Paul
• Granted Patent: US 8,211,054 B2
• Time in Patent Office: Days
• US Class Current: 604/67
• CPC Class Codes: A61M 2205/0288 Electro-rheological or magneto-rheological materials
• CPC Class Codes: A61M 2205/0294 Piezoelectric materials
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14224 Diaphragm type
• 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 5/16813 by controlling the degree of opening of the flow line
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

A system for controlling administration of medical fluid includes a fluid passageway to which is attached a first flow regulator, a second flow regulator, and a flow detector. The system also includes a controller for controlling the first and second flow regulators in response to a measurement taken by the flow detector of fluid movement in the fluid passageway. The first flow regulator, such as a pump, is configured to maintain fluid movement at flow values greater than an unrestricted flow value. The second flow regulator, such as a variable adjustable valve, is configured to maintain fluid movement at a flow value less than the unrestricted flow value. A method of controlling administration of medical fluid includes obtaining a target flow value, moving fluid through the disposable assembly, taking a measurement of fluid movement in the disposable assembly, and actuating a flow regulating apparatus.

Claims

1. A fluid control system for controlling administration of fluid from a medicament container, the system comprising:

a fluid passageway comprising an inlet, an outlet, and an internal volume through which unrestricted movement of fluid corresponds to an unrestricted flow value;

a first flow regulator attached to the fluid passageway and configured to keep fluid movement in the fluid passageway at a flow value greater than the unrestricted flow value;

a second flow regulator attached to the fluid passageway and configured to keep the fluid movement in the fluid passageway at a flow value less than the unrestricted flow value;

a flow detector attached to the fluid passageway and configured take a measurement of the fluid movement in the fluid passageway; and

a controller removably attached to the fluid passageway and coupled to the flow detector, the first flow regulator, and the second flow regulator, the controller configured to control the first and second flow regulators in response to the measurement by the flow detector.

2. The system of claim 1 wherein the first flow regulator comprises a pump chamber having a moveable wall coupled to a pump driver, the pump chamber disposed in the fluid passageway and configured for one-way fluid flow in a direction from the inlet to the outlet of the fluid passageway, the pump driver comprising an elastomeric dielectric film having a first side and a second side, the first side coated with a first expandable conductive film connected to a first electrode, the second side coated with a second expandable conductive film connected to a second electrode, the dielectric film configured to expand in response to a voltage applied to the first and second electrodes.

3. The system of claim 1 wherein the second flow regulator is further configured to keep the fluid movement in the fluid passageway at a flow value equal to the unrestricted flow value.

4. The system of claim 1 wherein the second flow regulator comprises a variably adjustable valve configured to restrict the fluid movement in the fluid passageway.

5. The system of claim 1 wherein the flow detector comprises:

a heat source disposed outside the internal volume of the fluid passageway and adapted to heat fluid located at a heating region in the fluid passageway;

a light source disposed outside the internal volume of the fluid passageway and adapted to produce an interrogating light directed toward fluid located at an interrogating region in the fluid passageway;

a light detector disposed outside the internal volume of the fluid passageway and adapted to detect optical characteristics of the fluid in the interrogating region, and to detect changes in the optical characteristics when the heated fluid from the heating region enters the interrogating region.

6. The system of claim 1 further comprising a wireless communication device adapted for bi-directional communication with a wireless network, the communication device connected to the controller and configured to receive a first set of drug delivery data from the network and to transmit a second set of drug delivery data to the network.

7. A method of controlling administration of fluid from a medicament container, the method comprising:

obtaining a target flow value;

moving fluid through a disposable assembly comprising a fluid passageway and a flow regulating apparatus, the fluid passageway comprising an inlet, an outlet, and an internal volume through which unrestricted movement of the fluid corresponds to an unrestricted flow value, the flow regulating apparatus comprising a first flow regulator and a second flow regulator;

taking a measurement of fluid movement in the fluid passageway; and

actuating the flow regulating apparatus when the fluid movement does not correspond to the target flow value, including changing the operational status of the second flow regulator when the target flow value is less than the unrestricted flow value, and changing the operational status of the first flow regulator when the target flow value is greater than the unrestricted flow value.

8. The method of claim 7 wherein actuating the flow regulating apparatus, includes changing the operational status of the second flow regulator when the target flow value is equal to the unrestricted flow value.

9. The method of claim 7 wherein actuating the flow regulating apparatus comprises actuating the flow regulating apparatus when there is a change in the amount of fluid in the medicament container or a change in elevation of the medicament container relative to an outlet of an administration tube extending from the outlet of the fluid passageway.

10. The method of claim 7 wherein actuating the flow regulating apparatus comprises applying a voltage to a first electrode and a second electrode, the first electrode connected to a first expandable conductive coating on a first side of an elastomeric dielectric film, the second electrode connected to a second expandable conductive coating on a second side of the elastomeric dielectric film, the elastomeric dielectric film coupled to a moveable wall disposed on the fluid passageway and configured to expand in response to the applied voltage.

11. The method of claim 7 wherein taking a measurement of fluid movement in the fluid passageway comprises:

heating fluid in a heating region in the fluid passageway, the fluid heated with a heat source disposed outside the internal volume of the fluid passageway;

illuminating fluid in an interrogating region in the fluid passageway, the fluid illuminated with a light source disposed outside the internal volume of the fluid passageway;

detecting optical characteristics of the fluid in the interrogating region, the optical characteristics detected with a light detector disposed outside the internal volume of the fluid passageway; and

detecting changes in the optical characteristics, the changes detected with the light detector.

12. The method of claim 7 wherein obtaining a target flow values comprises receiving a first set of drug delivery data from a network.

13. The method of claim 7 further comprising:

receiving a first set of drug delivery data from a network;

comparing the obtained target flow value with the first set of drug delivery data; and

transmitting a second set of drug delivery data to the network.

14. A fluid control system for controlling administration of fluid from a medicament container, the system comprising:

a primary fluid inlet;

a pump chamber in fluid communication with the primary fluid inlet, the pump chamber comprising a moveable wall and a pump outlet, the pump chamber configured for one-way fluid flow from the primary fluid inlet to the pump chamber and for one-way fluid flow from the pump chamber to the pump outlet;

a pump driver coupled to the moveable wall of the pump chamber and configured to move the moveable wall in response to a pump signal;

a flow restrictor in fluid communication with the pump outlet, the flow restrictor comprising a restrictor outlet and configured to selectively increase and decrease fluid flow through the restrictor outlet;

a restrictor driver connected to the flow restrictor and configured to actuate the flow restrictor device in response to a restrictor signal;

a flow detector comprising a fluid conduit disposed between the flow restrictor and the pump chamber, the flow detector configured to produce and detect a thermal change in fluid in the fluid conduit and to provide a detector signal representative of an existing fluid flow rate in the fluid conduit;

a user input device configured to obtain a target flow rate from a user; and

a controller in communication with the pump driver, the restrictor driver, and the flow detector, the controller configured to produce the pump signal and the restrictor signal to adjust the existing fluid flow rate to the target fluid flow rate and to automatically maintain the existing flow rate at the target fluid flow rate.

15. The system of claim 14 comprising a disposable assembly and a reusable assembly attached to the disposable assembly, the reusable assembly configured to be detached from the disposable assembly, the reusable assembly comprising the controller and the user input device, a display configured to communicate a flow rate, and a power source, the disposable assembly comprising the primary fluid inlet, the pump chamber, the pump driver, the flow restrictor, the restrictor driver, and the flow detector.

16. The system of claim 14 comprising a secondary fluid inlet, and wherein the pump chamber is in fluid communication with the secondary fluid inlet and the pump chamber is configured for one-way fluid flow from the secondary fluid inlet to the pump chamber.

17. The system of claim 14 wherein the flow restrictor comprises a manual adjustment device connected to the flow restrictor device, the manual adjustment device sized to be manipulated by the user and configured to change movement of fluid through the restrictor outlet.

18. The system of claim 14 wherein the pump chamber comprises a first check valve and a second check valve, the first and second check valves disposed between primary fluid inlet and the pump outlet.

19. The system of claim 14 wherein the pump driver comprises an elastomeric dielectric film having a first side and a second side, the first side coated with a first expandable conductive film connected to a first electrode, the second side coated with a second expandable conductive film connected to a second electrode, the dielectric film configured to expand in response to a voltage applied to the first and second electrodes.

20. The system of claim 14 wherein the pump driver comprises a first diaphragm comprising a first elastomeric dielectric film disposed between a first pair of expandable conductive coatings and a second diaphragm comprising a second elastomeric dielectric film disposed between a second pair of expandable conductive coatings, the first and second diaphragms coupled to the moveable wall of the pump chamber, the first diaphragm configured to move the moveable wall in a first direction in response to voltage applied to the first pair of coatings, the second diaphragm configured to move the moveable wall in a second direction in response to voltage applied to the second pair of coatings.

21. The system of claim 14 wherein the pump driver comprises a piezoelectric device coupled to the moveable wall of the pump chamber, the piezoelectric device configured to move the moveable wall in response to a voltage applied to the piezoelectric device.

22. The system of claim 14 wherein the detector signal from the flow detector represents a time period in which the thermal change travels a predetermined distance in the fluid conduit of the flow detector.

23. The system of claim 14 wherein the flow detector comprises:

a heat source disposed outside an internal volume of the fluid conduit of the flow detector, the heat source adapted to heat fluid in a heating region in the fluid conduit;

a light source disposed outside the internal volume and adapted to produce an interrogating light directed toward fluid in an interrogating region in the fluid conduit;

a light detector disposed outside the internal volume and adapted to detect optical characteristics of the fluid in the interrogating region, and to detect changes in the optical characteristics when the heated fluid from the heating region enters the interrogating region.

24. The system of claim 23 wherein the heat source is an optical device.

25. The system of claim 14 further comprising a communication device adapted for radio frequency communication with a network, the communication device connected to the controller and configured to receive a first set of drug delivery data from the network and to transmit a second set of drug delivery data to the network.