Medical fluid delivery system

• US 6,623,455 B2
• Filed: 02/20/2001
• Issued: 09/23/2003
• Est. Priority Date: 07/14/1999
• Status: Expired due to Term

• Current Assignee: Liebel Flarsheim Co LLC (Mallinckrodt plc)
• Original Assignee: Mallinckrodt Incorporated (Mallinckrodt plc)
• Inventors: Small, James R., Smith, Mitchell A., Tyson, Joseph B., Fago, Frank M., Wagner, Gary S.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Maynard, Jennifer
• Application Number:
  US09/788,791
• Publication Number:
  US 20010009994A1
• Time in Patent Office: 945 Days
• Field of Search: 128/DIG.12, 128/912, 128/898, 128/DIG.1, 604/411-415, 604/403, 604/85, 604/86, 604/239-241, 604/500, 604/507, 604/506, 604/131, 604/132, 604/141, 604/143, 604/151-153, 604/65, 604/67, 604/118, 604/217, 141/2, 141/18, 141/311.R, 141/329, 141/285, 141/301, 141/302, 141/382-389, 141/392
• US Class Current: 604/131
• 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 delivering a medical fluid to a patient comprising:

providing a plurality of unit doses of the medical fluid in a bulk container,

coupling a fill line of a delivery container selected from a plurality of delivery containers to a single connecting site of the bulk container,

transferring one of the unit doses of medical fluid through the fill line to a reservoir of the delivery container,

disconnecting the fill line of the delivery container irreversibly from the connecting site,

administering the unit dose of medical fluid from the delivery container through a patient connector line to an infusion site in the patient after disconnecting the fill line from the connecting site, and

discarding the fill line, the patient connector line and the delivery container after administering the unit dose of medical fluid to the infusion site.

2. The method of claim 1 wherein fluid flow is initiated by a method selected from the group consisting of gravity, pumping, mechanical pressure, hydraulic pressure, vacuum and combinations thereof.

3. The method of claim 1 wherein the delivery container has at least one flexible wall that contacts a pressurizeable chamber, and administering the unit dose of medical fluid further comprises:

delivering the unit dose of medical fluid to the infusion site by pressurizing the pressurizeable chamber.

4. The method of claim 3 wherein the chamber is pressurized through action of a pressure selected from the group consisting of hydraulic, mechanical, pneumatic and combinations thereof.

5. The method of claim 1 further comprising:

determining a customized volume for the unit dose of medical fluid transferred through the fill line to the reservoir of the delivery container.

6. The method of claim 5 wherein the customized volume is determined using at least one of patient specific data and procedure specific data.

7. The method of claim 1 wherein the steps of providing, transferring, disconnecting, and administering are performed substantially by automation.

8. The method of claim 1 further comprising:

determining a customized volume for the unit dose of medical fluid by an algorithm using at least one of patient specific data and procedure specific data.

9. The method of claim 1 further comprising:

providing a device to detect extravasation of medical fluid at the infusion site.

10. The method of claim 1 further comprising:

tracking a cumulative volume of medical fluid removed from the bulk container.

11. The method of claim 1 further comprising:

providing a plurality of delivery containers, each serially receiving a corresponding one of the unit doses of medical fluid from the bulk container at the connecting site, and

tracking a number of the plurality of delivery containers receiving medical fluid.

12. A method of delivering medical fluid to a patient comprising:

providing a system including

a bulk container holding a plurality of unit doses of medical fluid and a single connecting site,

a delivery container operatively connectable to the connecting site to receive one of the plurality of unit doses of medical fluid from the bulk container,

a patient connector line for administering the unit dose of medical fluid from the delivery container to an infusion site in the patient, and

a fill line capable of being connected in fluid communication with the single connecting site for transferring medical fluid from the bulk container to the delivery container and of being irreversibly disconnected from the connecting site,

transferring the unit dose of medical fluid through the fill line to a reservoir of the delivery container,

disconnecting the fill line of the delivery container irreversibly from the connecting site,

administering the unit dose of medical fluid from the delivery container through a patient connector line to an infusion site in the patient after disconnecting the fill line from the connecting site, and

discarding the fill line, the patient connector line and the delivery container after administering the unit dose of medical fluid to the infusion site.

13. The method of claim 12 wherein the delivery container is a syringe comprising

a barrel for containing the unit dose of medical fluid,

a filling port comprising a tube and a check valve,

a discharge port, and

a piston for discharging the unit dose of medical fluid through the discharge port, wherein the syringe is filled by sealing the discharge port to prevent fluid release, retracting the piston to allow fluid into the barrel and then sealing the filling port with the check valve to prevent further fluid in the barrel.

14. A method for providing medical fluid to a patient, comprising:

providing a bulk container containing a volume of medical fluid,

determining a customized supply of medical fluid for administration to the patient that is less than the volume of medical fluid in the bulk container,

coupling a fill line of a delivery container selected from a plurality of delivery containers to a single connecting site of the bulk container,

transferring the customized supply of medical fluid through the fill line to a reservoir of the delivery container,

disconnecting the fill line of the delivery container irreversibly from the connecting site,

administering the customized supply of medical fluid from the delivery container through a patient connector line to an infusion site in the patient after disconnecting the fill line from the connecting site, and

discarding the fill line, the patient connector line and the delivery container after administering the customized supply of medical fluid to the infusion site.

15. The method of claim 14 wherein the delivery container is selected from the group consisting of a bag and a syringe.

16. The method of claim 14 wherein the delivery container is a bag contacting a pressurizeable chamber and administering the customized supply further comprises:

providing a pressure to the pressurizeable chamber.

17. The method of claim 14 wherein the steps of providing, transferring, disconnecting, and administering are performed substantially by automation.

18. The method of claim 14 wherein the step of determining the customized supply forther comprises:

calculating a volume for the customized supply with an algorithm using at least one of patient specific data and procedure specific data.

19. The method of claim 14 further comprising:

flowing filtered air over the connecting site to maintain the sterility of the connecting site.