Medical fluid delivery system

• US 6,355,024 B1
• Filed: 07/14/1999
• Issued: 03/12/2002
• Est. Priority Date: 07/14/1999
• Status: Expired due to Term

• Current Assignee: Liebel-Flarsheim Company (Mallinckrodt plc)
• Original Assignee: Mallinckrodt Incorporated (Mallinckrodt plc)
• Inventors: Fago, Frank M., Small, James R., Wagner, Gary S., Smith, Mitchell A., Tyson, Joseph B.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/353,521
• Time in Patent Office: 972 Days
• Field of Search: 604/82, 604/83, 604/85, 604/86, 604/87, 604/88, 604/205, 604/19, 604/207-211, 604/232, 604/407, 604/411-415, 604/500-505, 141/29, 141/46, 141/35, 141/59, 141/309, 141/104-106, 141/329, 141/330, 141/375, 222/135-137
• US Class Current: 604/500
• CPC Class Codes: A61J 2200/76 for fluid level
• CPC Class Codes: A61J 2205/10 Bar codes
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 39/16 having provision for disinfection or sterilisation A61M39/143 takes precedence; methods or apparatus for disinfection or sterilisation A61L2/00
• CPC Class Codes: A61M 39/162 with antiseptic agent incorporated within the connector
• CPC Class Codes: A61M 39/165 Shrouds or protectors for aseptically enclosing the connector
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14224 Diaphragm type
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14

Abstract

A system to provide a specified volume of a medical fluid from a bulk source to a dose and/or delivery container for injection into a patient. The fluid path between the bulk container and the delivery container is physically separated at a connecting site before fluid is injected from the delivery container into the patient. The bulk container may be a bag or bottle, and the delivery container may be a syringe or bag. A bag delivery container may be contained in a pressurizeable chamber and fluid may be delivered by providing pressure to a membrane in the chamber contacting a wall of the bag. The system may be automated.

Claims

1. A method of maintaining sterility of a medical fluid comprising

providing a system including a bulk container a multipatient supply of the medical fluid, a connecting site fluidically coupled with the bulk container, and a dose container operably engaging the dose container in fluid communication with the connecting site;

transferring a unipatient supply of medical fluid from the bulk container through the connecting site to the dose container; and

sterilizing the connecting site by providing a sterilant in a non-contact manner from the sterilant source.

2. The method of claim 1 wherein the sterilant is provided by a unidirectional flow of filtered air over the connecting site in a controlled access compartment adjacent the connecting site.

3. The method of claim 1 wherein the sterilant is provided by irradiating the connecting site from a radiation source.

4. The method of claim 1 wherein the sterilant comprises at least one chemical contacting the connecting site.

5. The method of claim 1 further comprising a device causing said dose container to disconnect from said connecting site before providing said fluid to a patient.

6. The method of claim 1 wherein the sterilant is provided when said dose container is not operably engaged with said connecting site.

7. The method of claim 3 wherein the radiation source is in a controlled access compartment adjacent the connecting site.

8. The method of claim 1 further comprising a controlled access device adjacent the connecting site.

9. A method of maintaining sterility of a medical fluid comprising:

providing a system including a bulk container holding a multipatient supply of the medical fluid, a connecting site fluidically coupled with the bulk container, and a dose container;

operably engaging the dose container in fluid communication with the connecting site;

transferring a unipatient supply of the medical fluid from the bulk container through the connecting site to the dose container;

coupling a sterilant source in fluid communication with the connecting site; and

sterilizing the connecting site by providing a sterilant from the sterilant source to the connecting site.

10. The method of claim 9 wherein the sterilant comprises a unidirectional flow of filtered air.

11. The method of claim 9 wherein the sterilant comprises at least one chemical.

12. The method of claim 9 further comprising the step of operably disengaging the dose container from the connecting site before providing the unipatient supply of medical fluid to a patient.

13. The method of claim 9 wherein the steps of coupling and sterilizing are performed before the step of operably engaging.

14. The method of claim 13 further comprising the step of operably disengaging the dose container from the connecting site and repeating the step of sterilizing.

15. The method of claim 9 wherein the steps of coupling and sterilizing are performed after the step of operably engaging.

16. The method of claim 9 wherein the step of sterilizing is performed after the step of operably engaging.

17. The method of claim 9 further comprising the system includes a controlled access device enclosing the connecting site and wherein the step of operably engaging further comprises accessing the connecting site through the controlled access device.