Cassette and method for drug preparation and delivery

• US 7,798,997 B2
• Filed: 06/19/2006
• Issued: 09/21/2010
• Est. Priority Date: 08/22/1997
• Status: Expired due to Fees

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Manning, Robert, Grinnell, Charles M., Grant, Kevin Lee, Gilbreath, Dennis, Kamen, Dean, Demers, Jason A., Mandro, Marc A., Lanigan, Richard J., Larkins, William T.
• Primary Examiner(s): ROBINSON, DANIEL LEON
• Application Number:
  US11/455,494
• Publication Number:
  US 20060241550A1
• Time in Patent Office: 1,555 Days
• Field of Search: 604131-156, 604/67, 604/89, 604/85, 604/413, 141/1, 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 a drug in a vial includes a liquid inlet for connection to a liquid supply, a first vial spike, a second vial spike, a chamber and a valve mechanism. The chamber, the first and second vial spikes, and the liquid inlet are in fluid communication with each other. The valve mechanism may be actuated to control flow between the chamber, the vial receptacles and the liquid inlet.

Claims

1. A disposable cassette for diluting or reconstituting a medical substance, or mixing one or more medical substances, the cassette comprising:

a liquid inlet for connection to a liquid supply;

a first vial spike;

a second vial spike;

a third vial spike;

a pressure conducting chamber;

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

and a valve arrangement, which may be actuated to control flow among the chamber, the vial spikes and the liquid inlet.

2. A disposable cassette for diluting or reconstituting a medical substance, or mixing one or more medical substances, the cassette comprising:

a liquid inlet for connection to a liquid supply;

a first vial spike;

a second via spike;

a pressure conducting chamber;

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

and a valve arrangement, which may be actuated to control flow between the chamber, the vial spikes and the liquid inlet,

wherein the chamber is defined by a rigid wall and a flexible membrane, and

wherein the chamber further comprises an upper portion and a lower portion, a first conduit leads into the chamber'"'"'s upper portion, and a second conduit leads into the chamber'"'"'s lower portion, and a groove is defined in the rigid wall between the first and second conduits.

3. The cassette of claim 2, wherein the groove is smaller adjacent the first conduit than the second conduit.

4. A disposable cassette for diluting or reconstituting a medical substance, or mixing one or more medical substances, the cassette comprising:

a liquid inlet for connection to a liquid supply;

a first vial spike;

a second vial spike;

a pressure conducting chamber;

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

and a valve arrangement, which may be actuated to control flow between the chamber, the vial spikes and the liquid inlet,

wherein the valve arrangement 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.

5. A disposable cassette for diluting or reconstituting a medical substance, or mixing one or more medical substances, the cassette comprising:

a liquid inlet for connection to a liquid supply;

a first vial spike;

a second vial spike;

a pressure conducting chamber;

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

a valve arrangement, which may be actuated to control flow between the chamber, the vial spikes and the liquid inlet, and

a liquid outlet,

wherein the valve arrangement 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.

6. The cassette of claim 5, wherein the valve arrangement 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.

7. A disposable cassette for diluting or reconstructing a medical substance, or mixing one or more medical substances, the cassette comprising:

a liquid inlet for connection to as liquid supply;

a first vial spike;

a second vial spike;

a pressure conducting chamber;

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

and a valve arrangement, which may be actuated to control flow between the chamber, the vial spikes and the liquid inlet, and

a luer port in selective fluid communication with the chamber, the first and second vial spikes and the liquid inlet, wherein the valve arrangement includes a luer port valve that may be actuated to control flow to and from the luer port.

8. The cassette of claim 7, further including an air vent in fluid communication with the chamber, the first and second vial spikes, the luer port and the liquid inlet, wherein the valve arrangement may be actuated to control flow to and from the air vent.

9. A disposable cassette for delivering liquid medical substances having different compositions to an individual in need of medical treatment, the cassette comprising:

a liquid inlet for connection to a liquid diluent supply;

a first spike for connection to a medical substance container having a first composition;

a second spike for connection to a medical substance container having a second composition;

a third vial spike for connection to a medical substance container;

a first valve in fluid communication with the first spike;

a second valve in fluid communication with the second spike;

a third valve in fluid communication with the third spike;

a liquid inlet valve in fluid communication with the liquid inlet; and

a pump chamber having an inlet and an outlet, the inlet in selective fluid communication with the first, second and third valves, and the liquid inlet valve, and the outlet in fluid communication with tubing connected to a treatment access site of a patient;

wherein

the first, second and third valves, and the liquid inlet valve can be selectively actuated to control flow between the pump chamber and the spikes and liquid inlet.