System for delivering intravenous drugs

• US 6,210,361 B1
• Filed: 08/20/1998
• Issued: 04/03/2001
• Est. Priority Date: 08/22/1997
• Status: Expired due to Term

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Demers, Jason A., Mandro, Marc A., Kamen, Dean L., Grant, Kevin, Larkins, William T., Manning, Robert, Grinnell, Charles M., Gilbreath, Dennis, Lanigan, Richard
• Primary Examiner(s): KENNEDY, SHARON E
• Application Number:
  US09/137,025
• Time in Patent Office: 957 Days
• Field of Search: 604/30, 604/31, 604/35, 604/65, 604/82, 604/85, 604/86, 604/87, 604/130, 604/89-92, 604/246, 604/518-520, 604/257, 604/258, 604/262, 604/403, 604/131, 604/408-410
• US Class Current: 604/82
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2005/1403 Flushing or purging
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/35 Communication
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2206/22 eliminating pulsatile flows, e.g. by the provision of a dampening chamber
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 5/1409 in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems needle sets A61M5/162
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• 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 5/16827 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 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate
• CPC Class Codes: A61M 5/365 Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: F16K 5/0414 : Plug channel at 90 degrees to the inlet
• CPC Class Codes: F16K 5/0478 : on the plug

Abstract

A bedside-pharmacy systen for the preparation and delivery of intravenous drugs. The system includes a liquid inlet for connection to a liquid supply, vial receptacles, and a liquid outlet for providing the intravenous drug in mixed, liquid form to the patient. The system may include a chamber having a variable volume, and a valve mechanism, which may be actuated to control flow between the liquid outlet, the variable-volume chamber, the vial receptacles and the liquid inlet. The system induces change in the volume of the variable-volume chamber and actuates the valve mechanism, so as to introduce liquid from the liquid inlet into the vials and reconstitute or dilute the drugs and so as to deliver the drugs to the patient. In a preferred embodiment, the liquid inlet, the vial receptacles, the variable-volume chamber, the liquid outlet and the valve mechanism (in other words, all components that come into contact with the liquid) are located in a disposable cassette, which may be received in a control unit. The system may include means for changing the chamber volume and actuating the valves so as to move the liquid repeatedly between a vial and the chamber. After the drug has been reconstituted, the system may cause the drug to be further diluted by providing an additional volume of liquid to be mixed with the drug. The system may further include a second chamber for delivery of the drug to the patient in precise quantities.

Claims

1. A system for preparing and delivering an intravenous drug from a vial to a patient, the system comprising:

a liquid inlet for connection to a liquid supply;

a vial receptacle;

a chamber having a variable volume;

a liquid outlet for providing the intravenous drug in mixed, liquid form to the patient, the liquid outlet, the variable-volume chamber, the vial receptacle and the liquid inlet being in fluid communication with each other;

a valve mechanism, which may be actuated to control flow between the liquid outlet, the variable-volume chamber, the vial receptacle and the liquid inlet;

a device for inducing change in the volume of the variable-volume chamber;

an apparatus for actuating the valve mechanism; and

a controller for controlling the volume-changing device and the valve-actuating apparatus, so as to introduce liquid from the liquid inlet into the vial and so as to deliver the drug to the patient.

2. A system according to claim 1 wherein the liquid inlet, the vial receptacle, the variable-volume chamber, the liquid outlet and the valve mechanism are located in a disposable cassette, and wherein the volume-changing device, the valve-actuating apparatus and the controller are located in a reusable control unit for receiving and controlling the disposable cassette.

3. The system of claim 2 wherein the valve mechanism includes an outlet free-flow-prevention valve which is closed to prevent flow through the liquid outlet when the cassette is removed from the control unit.

4. The system of claim 3 wherein the valve mechanism includes an inlet free-flow-prevention valve which is closed to prevent flow through the liquid inlet when the cassette is removed from the control unit.

5. The system of claim 4 wherein the inlet and outlet free-flow-prevention valves are permanently closed when the cassette is removed from the control unit.

6. The system of claim 1 wherein the valve mechanism includes first and second valve chambers, wherein each of the first and second valve chambers is defined by a rigid wall and a flexible membrane.

7. The system of claim 6 wherein the valve-actuating apparatus includes a cam and a pair of actuators, each actuator being disposed adjacent the flexible membrane of one of the first and second chambers so that movement of the actuator causes a change in pressure on the flexible membrane, wherein the cam and actuators are disposed with respect to each other such that, as the cam is rotated, the actuators are moved.

8. The system of claim 7 wherein the cam is shaped so that at any time at least one actuator is urging the corresponding flexible membrane into a closed position.

9. The system of claim 1 further including a second vial receptacle in fluid communication with the liquid outlet, the variable-volume chamber, the first vial receptacle and the liquid inlet, wherein the valve mechanism may be actuated to control flow to and from the second vial receptacle.

10. The system of claim 9 further including a third vial receptacle in fluid communication with the liquid outlet, the variable-volume chamber, the first and second vial receptacles and the liquid inlet, wherein the valve mechanism may be actuated to control flow to and from the third vial receptacle.

11. The system of claim 10 further including a port in fluid communication with the liquid outlet, the variable-volume chamber, the first, second and third vial receptacles and the liquid inlet, wherein the valve mechanism may be actuated to control flow to and from the port.

12. The system of claim 11 further including an air vent in fluid communication with the liquid outlet, the variable-volume chamber, the first, second and third vial receptacles, the port and the liquid inlet, wherein the valve mechanism may be actuated to control flow to and from the air vent.

13. The system of claim 1 wherein the controller includes means for causing the volume-changing device and the valve-actuating apparatus to move the liquid repeatedly between the vial and the chamber.

14. The system of claim 1 wherein the controller includes means for causing the volume-changing device and the valve-actuating apparatus to provide an additional volume of liquid to the drug to attain the desired concentration.

15. The system of claim 14 wherein the system further includes a delivery chamber, and wherein the additional volume of liquid is adapted to be mixed with the drug in the delivery chamber.

16. The system of claim 15 wherein the delivery chamber has a variable volume.

17. A system according to claim 16 wherein the liquid inlet, the vial receptacle, the variable-volume chamber, the delivery chamber, the liquid outlet and the valve mechanism are located in a disposable cassette, and wherein the volume-changing device, the valve-actuating apparatus and the controller are located in a reusable control unit for receiving the disposable cassette.

18. The system of claim 1 further comprising:

a variable-volume delivery chamber;

the delivery chamber, the liquid outlet, the variable-volume chamber, the vial receptacle and the liquid inlet being in fluid communication with each other.

19. A system according to claim 18 wherein the liquid inlet, the vial receptacle, the variable-volume chamber, the variable-volume delivery chamber, the liquid outlet and the valve mechanism are located in a disposable cassette, and wherein the volume-changing device, the valve-actuating apparatus and the controller are located in a reusable control unit for receiving and controlling the disposable cassette.

20. A system for delivering a dose of medication to a patient, the system comprising:

a disposable cassette having

a first variable-volume chamber having a first valved inlet leading from a medication supply and a first valved outlet leading to the patient,

a second variable-volume chamber having a second valved inlet and a second valved outlet, the second valved inlet and the second valved outlet leading to the medication supply,

a manifold providing fluid communication between the medication supply and the chambers,

an air vent in fluid communication with the manifold, and

an air valve controlling flow between the air vent and the manifold; and

a reusable control unit having

a device for inducing change in the volume of the chambers,

an apparatus for actuating the first and the second valved inlets, the first and the second valved outlets, and the air valve, and

a controller for controlling the volume-changing device and the valve-actuating apparatus, so as to isolate the chambers from each other and allow the system to move fluid back and forth between the supply and the second chamber while delivering medication to the patient, the medication delivered from the first valved outlet.

21. The system according to claim 20, wherein the controller includes means for determining whether any air has entered the chamber, and means for forcing the air from the chamber into the manifold.

22. The system according to claim 21, wherein the valve-actuating means includes means for opening the inlet valve only part way.

23. A system for delivering an intravenous drug from a vial to a patient, the system comprising:

a liquid inlet for connection to a supply of a liquid;

a vial receptacle for connection to a vial providing a solute to be mixed with the liquid so as to form the intravenous drug;

a chamber having a variable volume;

a liquid outlet for providing the intravenous drug to the patient, the liquid outlet, the variable-volume chamber, the vial receptacle and the liquid inlet being in fluid communication with each other;

valve means for controlling flow between the liquid outlet, the variable-volume chamber, the vial receptacle and the liquid inlet;

volume means for inducing change in the volume of the variable-volume chamber; and

controller means for controlling the volume means and the valve means, so as to mix the liquid and the solute and so as to deliver the drug to the patient.

24. A system according to claim 23, wherein the valve means includes

(i) a valve mechanism, which may be actuated to control flow between the liquid outlet, the variable-volume chamber, the vial receptacle and the liquid inlet; and

(ii) an apparatus for actuating the valve mechanism;

wherein the liquid inlet, the vial receptacle, the variable-volume chamber, the liquid outlet and the valve mechanism are located in a disposable cassette and wherein the volume means, the valve-actuating apparatus and the controller are located in a reusable control unit for receiving and controlling the disposable cassette.

25. The system of claim 24 wherein the valve mechanism includes an outlet free-flow-prevention valve which is closed to prevent flow through the liquid outlet when the cassette is removed from the control unit.

26. The system of claim 25 wherein the valve mechanism includes an inlet free-flow-prevention valve which is closed to prevent flow through the liquid inlet when the cassette is removed from the control unit.

27. The system of claim 26 wherein the inlet and outlet free-flow-prevention valves are permanently closed when the cassette is removed from the control unit.

28. The system of claim 24 wherein the valve mechanism includes first and second valve chambers, wherein each of the first and second valve chambers is defined by a rigid wall and a flexible membrane.

29. The system of claim 24 wherein the valve-actuating apparatus includes a cam and a pair of actuators, each actuator being disposed adjacent the flexible membrane of one of the first and second chambers so that movement of the actuator causes a change in pressure on the flexible membrane, wherein the cam and actuators are disposed with respect to each other such that, as the cam is rotated, the actuators are moved, wherein the cam is shaped so that any time at least one actuator is urging the corresponding flexible membrane into a closed position.

30. The system of claim 23 further including a second vial receptacle in fluid communication with the liquid outlet, the variable-volume chamber, the first vial receptacle and the liquid inlet, wherein the valve means controls flow to and from the second vial receptacle.

31. The system of claim 30 further including a third vial receptacle in fluid communication with the liquid outlet, the variable-volume chamber, the first and second vial receptacles and the liquid inlet, wherein the valve means controls flow to and from the third vial receptacle.

32. The system of claim 23 further including an air vent in fluid communication with the liquid outlet, the variable-volume chamber, the vial receptacle, and the liquid inlet, wherein the valve means controls flow to and from the air vent.

33. The system of claim 23 wherein the control means includes means for causing the volume means and the valve means to move the liquid repeatedly between the vial and the chamber.

34. A system according to claim 23 further comprising:

a delivery chamber;

the delivery chamber;

the liquid outlet, the variable-volume chamber, the vial receptacle and the liquid inlet being in fluid communication with each other.

35. A system according to claim 34 wherein the delivery chamber has a variable volume.

36. A system according to claim 35 wherein the liquid inlet, the vial receptacle, the variable-volume chamber, the variable-volume delivery chamber, the liquid outlet and the valve mechanism are located in a disposable cassette, and wherein the volume-changing device, the valve-actuating apparatus and the controller are located in a reusable control unit for receiving and controlling the disposable cassette.