Method and assembly for fluid transfer and drug containment in an infusion system

• US 8,562,583 B2
• Filed: 03/26/2002
• Issued: 10/22/2013
• Est. Priority Date: 03/26/2002
• Status: Active Grant

• Current Assignee: Carmel Pharma AB (Becton, Dickinson & Co)
• Original Assignee: Carmel Pharma AB (Becton, Dickinson & Co)
• Inventors: Andreasson, Kjell, Horppu, Petri, Akerlund, Roger
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): SCHELL, LAURA C
• Application Number:
  US10/063,159
• Publication Number:
  US 20030187420A1
• Time in Patent Office: 4,228 Days
• Field of Search: 604 80- 87, 604/408, 604411-416, 604/403, 604/905
• US Class Current: 604/411
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1425 Snap-fit type
• CPC Class Codes: A61J 1/1468 Containers characterised by specific material properties
• CPC Class Codes: A61J 1/1481 with connection retaining means, e.g. thread or snap-fit
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2034 having separation clips
• CPC Class Codes: A61J 1/2055 having gripping means
• 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: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2039/222 frangible within tubing or bags
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• 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

Abstract

A fluid transfer assembly, drug container, and method for enabling fluid transfer in an infusion system is taught. The assembly includes a fluid container containing an infusion fluid, and a drug container. The fluid container has at least one inlet port for receiving a medical substance from the drug container. The assembly further includes at least one fluid barrier controlling fluid passage between the drug container and the fluid container. The inlet port exhibits a first luer-lock connector, and the drug container is sealed by a cap exhibiting a second luer-lock connector for attachment to the first luer-lock connector. The fluid barrier is designed and arranged to be ruptured by an external force to allow the fluid passage.

Claims

1. A fluid transfer assembly for use in an infusion system, said assembly comprising:

a fluid container having an infusion fluid,

a drug container having a medical substance,

at least one fluid barrier controlling fluid passage between said drug container and said fluid container,

said fluid container further comprising at least one inlet port for receiving said medical substance from said drug container, wherein said at least one inlet port comprises a protruding resilient tube,

a hollow spike member arranged to be retained inside said protruding resilient tube of said inlet port and provided with a first luer-lock connector,

said drug container further comprising a cap for sealing said drug container,

said cap further comprising a second luer-lock connector for attachment to said first luer-lock connector and a protruding member comprising a more flexible material than said second luer-connector and said drug container, and

wherein said at least one fluid barrier is designed and arranged to be ruptured by an external twisting, bending, or squeezing force to allow said fluid passage.

2. The fluid transfer assembly according to claim 1, said protruding member forming a second fluid duct between said drug container and said second luer-lock connector, wherein a fluid barrier is provided inside said second fluid duct.

3. The fluid transfer assembly according to claim 1, said second luer-lock connector further comprising a pierceable closure for protection before use.

4. The fluid transfer assembly according to claim 1, said drug container further comprising an opening sealed by a closure, and said cap further comprising a hollow needle for penetrating said closure.

5. The fluid transfer assembly according to claim 1, said drug container further comprising a neck, said protruding member forming a second fluid duct between said drug container and said second luer-lock connector, and said cap further comprising locking members for grasping said neck.

6. The fluid transfer assembly according to claim 1, said fluid barrier further comprising a brittle polymer member dividable along a weakening line by said external twisting, bending, or squeezing force.

7. The fluid transfer assembly according to claim 1, said protruding member forming a second fluid duct between said drug container and said second luer-lock connector, said fluid transfer assembly further comprising a second clamping member for compressing said protruding member, thereby closing said second fluid duct and preventing undesirable fluid passage between said second luer-lock connector and said drug container.

8. The fluid transfer assembly according to claim 1, said at least one inlet port, in addition to said first luer-lock connector, further comprising an infusion line attached thereto, and said fluid transfer assembly further comprising a third clamping member for compressing said infusion line, thereby preventing undesirable fluid passage there through.

9. The fluid transfer assembly according to claim 1, said protruding member forming a second fluid duct between said drug container and said second luer-lock connector,

said fluid barrier being provided inside said second fluid duct, said drug container comprising a rigid material, and

said fluid barrier comprising a more brittle material than said drug container, said protruding portion, and said second luer-lock connector.

10. The fluid transfer assembly according to claim 1, wherein the composition of said drug container is selected from the group consisting of glass and a rigid polymer material.