Methods and systems for filling IV bags with therapeutic fluid

• US 9,849,236 B2
• Filed: 06/22/2015
• Issued: 12/26/2017
• Est. Priority Date: 11/25/2013
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Hachey, Jay, McCall, Thomas, Woodbury, Jason
• Primary Examiner(s): Medway, Scott
• Application Number:
  US14/746,048
• Publication Number:
  US 20150283322A1
• Time in Patent Office: 918 Days
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• CPC Class Codes: A61M 5/1411 Drip chambers A61M5/162, A61M5/1689, A61M5/40 take precedence
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/1415 Stands, brackets or the like for supporting infusion accessories
• 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
• CPC Class Codes: A61M 5/16809 by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142

Abstract

A portable electronic fluid dispensing system can provide pre-filled, pre-primed IV bag assemblies comprising therapeutic fluids. The same fluid line and connector in the IV bag assembly can be used to fill the IV bag as is used to withdraw fluid from the IV bag and infuse such fluid into the patient. The connection points along the IV assembly, such as the connection between the IV bag and a drip chamber, or between an IV bag and tubing, or between a drip chamber and tubing, or between tubing and a closeable, resealable connector, can each be resistant to disconnection by a user. The healthcare practitioner at the patient care site is not required to attach any of these components to each other, and the healthcare practitioner at the patient care site is not required to introduce a spike into a spike port on the IV bag.

Claims

1. A method of using an IV assembly with an electronic system to prime the IV assembly with therapeutic medical fluid for a patient, the method comprising:

obtaining an IV assembly, the IV assembly comprising;

an empty IV bag with an outlet on a lower side; and

a patient-administration tubing comprising a closeable male luer connector with a first end and a second end, the first end of the closeable male luer connector being attached in fluid communication with the patient-administration tubing, the closeable male luer connector comprising an open position and a closed position for sealing fluid within the IV assembly,

wherein the patient-administration tubing is permanently attached in fluid communication with the IV bag;

attaching the closeable male luer connector to the electronic system;

priming the IV assembly by pushing fluid through the closeable male luer connector, through the patient-administration tubing, and into the IV bag using the electronic system; and

closing the closeable male luer connector to provide a closed, primed IV assembly that is configured to connect to an access point in an IV tube attached to a patient such that the primed IV assembly is configured to allow the fluid in the primed IV assembly to be conveyed through the patient-administration tubing of the primed IV assembly to the access point without requiring additional priming of at least one of the patient-administration tubing or the closeable male luer connector.

2. The method of claim 1, in which the IV bag further comprises at least one access port for permitting additional fluid to be introduced into the IV bag or for permitting at least a portion of fluid that is introduced into the IV bag to be removed.

3. The method of claim 2, in which the IV bag comprises at least two access ports.

4. The method of claim 3, in which one of the access ports is a closeable female luer connector and one of the access ports comprises a pierceable septum.

5. The method of claim 1, in which the patient-administration tubing neither comprises nor is attached to a bag spike for piercing a septum on the IV bag to access interior of the IV bag.

6. The method of claim 1, in which the closeable male luer connector comprises a male end that includes an interior closure element that is flush with the male end in the closed position.

7. The method of claim 1, wherein the patient-administration tubing of the IV assembly is at least about 2½

feet long.

8. The method of claim 1, wherein the IV assembly has no spike-port.

9. The method of claim 1, wherein the IV assembly forms a closed system.

10. The method of claim 1, wherein the IV assembly is configured so that all liquid can be passed into and out of the IV assembly through a single fluid line and connector.

11. The method of claim 1, wherein the closable male luer connector is permanently attached in fluid communication with the patient-administration tubing.

12. The method of claim 1, wherein one or more connection points between the patient-administration tubing and at least one of the IV bag and the closeable male luer connector comprises a rotating or swiveling connection to help avoid tangling or kinking of the patient-administration tubing.

13. The method of claim 1, wherein the patient-administration tubing is sufficiently long to be capable of extending from the outlet of the IV bag to the access point in the IV tube attached to the patient when the patient is in a lying position and the IV assembly is attached to a pole stand.

14. The method of claim 1, wherein the patient-administration tubing further comprises a drip chamber.

15. The method of claim 14, wherein the drip chamber is permanently attached in fluid communication with the patient-administration tubing.

16. The method of claim 15, wherein the step of filling the IV bag does not require attaching the drip chamber to the patient-administration tubing.

17. The method of claim 1, wherein the closable male luer connector is removably attached in fluid communication with the patient-administration tubing.

18. The method of claim 11, wherein the step of filling the IV bag does not require attaching the closeable male luer connector to the patient-administration tubing.

19. The method of claim 11, wherein the patient-administration tubing and the closeable male luer connector are permanently attached by way of solvent or ultrasonic welding.

20. The method of claim 18, wherein the step of closing the closeable male luer connector comprises detaching the closeable male luer connect from the electronic system.