Cassette and method for drug preparation and delivery

• US 20040176724A1
• Filed: 03/16/2004
• Published: 09/09/2004
• Est. Priority Date: 08/22/1997
• Status: Active Grant

• Current Assignee: Charles M. Grinnell, Dean Kamen, Dennis Gilbreath, Jason A. Demers, Kevin Grant, Marc A. Mandro, Richard Lanigan, Robert Manning, William T. Larkins
• Original Assignee: Charles M. Grinnell, Dean Kamen, Dennis Gilbreath, Jason A. Demers, Kevin Grant, Marc A. Mandro, Richard Lanigan, Robert Manning, William T. Larkins
• Inventors: Kamen, Dean L,, Demers, Jason A., Mandro, Marc A., Grant, Kevin, Larkins, William T., Manning, Robert, Grinnell, Charles M., Gilbreath, Dennis, Lanigan, Richard
• Granted Patent: US 7,214,210 B2
• Time in Patent Office: Days
• US Class Current: 604/131
• 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 disposable cassette for mixing an intravenous drug in a vial to a patient includes a liquid inlet for connection to a liquid supply, a first vial spike, a second vial spike and a chamber. The chamber, the first and second vial spikes, and the liquid inlet are in fluid communication with each other. A valve mechanism may be actuated to control flow between the chamber, the vial receptacles and the liquid inlet.

Claims

1. A method for preparing an intravenous drug in a vial to a patient, the method comprising:

providing a disposable cassette having (i) a liquid inlet, (ii) a vial receptacle, and (iii) a chamber;

attaching a supply of liquid to the liquid inlet;

attaching the vial containing the drug to the vial receptacle;

introducing a volume of liquid into the vial; and

causing the liquid to flow between the vial and the chamber.

2. The method according to claim 1, further comprising”

causing an additional volume of liquid to be mixed with the drug so as to further dilute the drug.

3. The method according to claim 2, wherein the cassette is provided with a delivery chamber, and wherein the additional volume of liquid is mixed with the drug in the delivery chamber.

4. A disposable cassette for mixing an intravenous drug in a vial to a patient, the cassette comprising:

a liquid inlet for connection to a liquid supply;

a first vial spike;

a second vial spike;

a chamber;

the chamber, the first and second vial spikes, and the liquid inlet being in fluid communication with each other; and

a valve mechanism, which may be actuated to control flow between the chamber, the vial receptacles and the liquid inlet.

5. The cassette of claim 4, further including a third vial spike in fluid communication with the 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 spike.

6. The cassette of claim 4, wherein the chamber is defined by a rigid wall and a flexible membrane.

7. The cassette of claim 6, wherein a first conduit leads into the chamber'"'"'s upper half and a second conduit leads into the chamber'"'"'s lower half, and a groove is defined in the rigid wall between the first and second conduits.

8. The cassette of claim 7, wherein the groove is shallow adjacent the first conduit and wide adjacent the second conduit.

9. The cassette of claim 4, wherein the valve mechanism includes first and second valve chambers disposed respectively in first and second conduits leading to the chamber, wherein each of the first and second valve chambers is defined by a rigid wall and a flexible membrane.

10. The cassette of claim 4, further including a liquid outlet and 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 a control unit which actuates the valve mechanism.

11. The cassette of claim 10, 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.

12. The cassette of claim 11, wherein the inlet and outlet free-flow-prevention valves are permanently closed when the cassette is removed from the control unit.

13. The cassette of claim 4, further including a female luer fitting in fluid communication with the 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 female luer fitting.

14. The cassette of claim 13, further including an air vent in fluid communication with the chamber, the first and second vial receptacles, the female luer fitting and the liquid inlet, wherein the valve mechanism may be actuated to control flow to and from the air vent.

15. A disposable cassette comprising:

a liquid inlet for receiving an IV solution;

a vial inlet for receiving a medication;

an outlet; and

an outlet free-flow-prevention valve which, when actuated, is permanently closed to prevent flow through the outlet.

16. The cassette of claim 15, wherein the outlet free-flow-prevention valve includes a valve chamber defined by a rigid portion of the cassette and a membrane, wherein the membrane includes a folded portion that extends towards the outside of the cassette, so that when the folded portion the membrane collapses into the valve chamber flow is restricted therethrough.

17. The cassette of claim 15, further including an inlet free-flow-prevention valve which is permanently closed to prevent flow through the liquid inlet.

18. The cassette of claim 15, wherein each of the inlet and outlet free-flow-prevention valves includes a valve chamber defined by a rigid portion of the cassette and a membrane, wherein the membrane includes a folded portion that extends towards the outside of the cassette, so that when the folded portion the membrane collapses into the valve chamber flow is restricted therethrough.

19. A method of delivering a dose of medication to a patient, the method comprising:

providing a cassette having a chamber having an inlet leading from a medication supply and an outlet leading to the patient, a manifold providing fluid communication between the medication supply and the chamber, an outlet valve controlling flow out of the chamber, an inlet valve controlling flow between the chamber and the manifold, and an air valve controlling flow of air through the manifold;

moving a first volume of medication from the supply through the manifold to the chamber;

delivering the first volume of medication from the chamber to the patient;

moving a second volume of medication from the supply through the manifold towards the chamber;

urging air through the manifold to force substantially all the medication from the manifold into the chamber; and

delivering the second volume of medication from the chamber to the patient.

20. The method according to claim 19, further including:

determining whether any air has entered the chamber; and

forcing the air from the chamber into the manifold.

21. The method according to claim 20, wherein forcing air from the chamber includes opening and closing the air valve while applying a pressure to the chamber.

22. The method according to claim 21, wherein the air valve is only opened part way.