Cassette and method for drug preparation and delivery

• US 7,214,210 B2
• Filed: 03/16/2004
• Issued: 05/08/2007
• Est. Priority Date: 08/22/1997
• Status: Expired due to Fees

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Kamen, Dean, Demers, Jason A., Mandro, Marc A., Lanigan, Richard J., Larkins, William T., Manning, Robert, Grinnell, Charles M., Grant, Kevin Lee, Gilbreath, Dennis
• Primary Examiner(s): Evans; Robin
• Assistant Examiner(s): Fastovsky; Leonid M.
• Application Number:
  US10/803,049
• Publication Number:
  US 20040176724A1
• Time in Patent Office: 1,148 Days
• Field of Search: 604/131, 604/67, 604/89, 604/85, 604/413, 604/153, 141 83-104
• 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, the method comprising:

providing a disposable cassette having (i) a liquid inlet for receiving a supply of liquid, (ii) a first vial spike, (iii) a second vial spike, (iv) a variable-volume mixing chamber, the mixing chamber, the first and second vial spikes, and the liquid inlet being in fluid communication with each other, and (v) a valve mechanism, which may be actuated to control flow between the mixing chamber, the vial receptacles and the liquid inlet;

attaching the supply of liquid to the liquid inlet;

attaching a first vial containing a drug to the first vial spike;

introducing liquid from the liquid supply into the mixing chamber;

measuring and introducing a first volume of liquid from the mixing chamber into the first vial;

causing liquid to flow between the first vial and the mixing chamber;

attaching a second vial containing a drug to the second vial spike;

measuring and introducing a second volume of liquid from the mixing chamber into the second vial; and

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

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

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

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

4. A method for preparing an intravenous drug in a vial, the method comprising:

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

attaching a supply of liquid to the liquid inlet;

attaching the vial containing a powdered 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 to mix the powdered drug with the volume of liquid,

wherein the liquid is caused to flow repeatedly back and forth between vial and the chamber.

5. The method according to claim 4, further comprising:

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

6. The method according to claim 5, 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.

7. A method for preparing an intravenous drug in a vial, the method comprising:

providing a disposable cassette having (i) a liquid inlet, (ii) a vial receptacle, (iii) a mixing chamber, and (iv) a delivery chamber in communication with an outlet port, and wherein both the mixing chamber and the delivery chamber are in valved communication with the inlet port;

attaching a supply of liquid to the liquid inlet;

attaching the vial containing the drug to the vial receptacle;

measuring a volume of liquid in the delivery chamber;

causing the volume of liquid to flow to the mixing chamber;

introducing the volume of liquid into the vial; and

causing the liquid to flow repeatedly back and forth between the vial and the mixing chamber to create a mixture.

8. The method according to claim 7, further comprising:

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

9. The method according to claim 8, wherein the additional volume of liquid is mixed with the drug in the delivery chamber.