Method and device for fluid transfer in an infusion system

• US 7,867,215 B2
• Filed: 04/17/2002
• Issued: 01/11/2011
• Est. Priority Date: 04/17/2002
• Status: Active Grant

• Current Assignee: Carmel Pharma AB (Becton, Dickinson & Co)
• Original Assignee: Carmel Pharma AB (Becton, Dickinson & Co)
• Inventors: Åkerlund, Roger, Andreasson, Kjell
• Primary Examiner(s): Deak; Leslie R
• Application Number:
  US10/063,386
• Publication Number:
  US 20030199847A1
• Time in Patent Office: 3,191 Days
• Field of Search: 604/403, 604411-416, 604/905, 206/222, 206/265
• US Class Current: 604/413
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2051 having tap means, e.g. tap means activated by sliding
• 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

Abstract

A fluid transfer device for use in an infusion system having a first end and a second end for coupling to an injection port of the infusion system. The device further includes at least a first member, a hollow needle attached to the first member, and a second member telescopically displaceable in relation to the first member, allowing the hollow needle to penetrate a flexible barrier member sealing the injection port thereby creating a fluid passage into the infusion system. The first end has a connecting portion for attachment to a drug bottle containing a fixed dose of a medical substance, and the second end has a flexible membrane able to be pressed against the flexible barrier member with a pressure sufficient to create a double-membrane sealing around the hollow needle.

Claims

1. A fluid transfer device for temporarily establishing fluid communication between a drug bottle and an infusion fluid container that is adapted for transferring a medical substance from the drug bottle to the infusion fluid container for mixture with infusion fluid contained therein and the fluid transfer device is configured to prevent leakage of the medical substance into the ambient environment during both transfer of the medical substance into the infusion fluid container and after disconnect of the fluid transfer device from the infusion fluid container, said fluid transfer device comprising:

a first end including a connecting portion for interconnection with a drug bottle containing a fixed dose of a medical substance;

a second end opposite said first end and configured to be releasably coupled to an injection port of the infusion fluid container that is sealed by a pierceable flexible barrier, said second end of said transfer device having a flexible membrane located to be pressed against the flexible barrier of the injection port when coupled thereto; and

a first member having a hollow needle attached thereto and said first member being telescopically associated with a second member so that upon displacement in a first direction of said first member relative to said second member when said fluid transfer device is coupled to the injection port, said hollow needle pierces said flexible membrane and the flexible baffler whereby creating a fluid passage from said first end into the infusion fluid container with whereby a double membrane seal is formed around said hollow needle by said flexible membrane and said flexible barrier of the injection port, and wherein said first member is arranged to be displaceable in a second opposite direction while said fluid transfer device is connected to said infusion fluid container and said drug bottle, to reverse said displacement relative to said second member.

2. The fluid transfer device according to claim 1, wherein said second end is configured to create said double-membrane seal around said hollow needle when the injection port is provided on a flexible infusion bag.

3. The fluid transfer device according to claim 1, wherein said second end is configured to create said double-membrane seal around said hollow needle when the injection port is provided on au infusion fluid line.

4. The fluid transfer device according to claim 1, wherein said second end is configured to create said double-membrane seal around said hollow needle when the injection port is connected to a spike device exhibiting the flexible barrier.

5. The fluid transfer device according to claim 1, wherein said second end is configured to create a double-membrane bayonet coupling with the injection port.

6. The fluid transfer device according to claim 1, said connecting portion comprising at least one locking member for grasping a bottle neck of the drug bottle in permanent attachment thereto, and said connecting portion further comprising a hollow piercing member for penetrating a bottle cap of the drug bottle and thereby extending said fluid passage into the drug bottle.

7. The fluid transfer device according to claim 1, said connecting portion comprising a hollow piercing member for penetrating a bottle cap of the drug bottle and thereby extending said fluid passage into the drug bottle, and wherein neighboring ends of said hollow piercing member and said hollow needle are configured to allow fluid communication through said hollow piercing member into said hollow needle.

8. The fluid transfer device according to claim 1, said connecting portion comprising a hollow piercing member for penetrating a bottle cap of the drug bottle and thereby extending said fluid passage into the drug bottle, said hollow piercing member comprising a sharpened end of said hollow needle exposed at said first end or said fluid transfer device.

9. The fluid transfer device according to claim 1, said connecting portion comprising a first coupling member engageable with a second coupling member provided on a bottle cap of the drug bottle and thereby establishing a luer-lock coupling.

10. The fluid transfer device according to claim 1, further comprising:

said connecting portion comprising a first coupling portion member configured for attachment to a second coupling member provided on a bottle cap of the drug bottle; and

a fluid baffler member provided in a duct extending between an interior of the drug bottle and said second coupling member, said fluid barrier member ruptureable by means of an external force which extends said fluid passage into the drug bottle.

11. The fluid transfer device according to claim 1, said connecting portion comprising a first coupling member attachable to a second coupling member whereby said second coupling member is permanently attached to the drug bottle utilizing an annular capsule member.

12. The fluid transfer device according to claim 1, said connecting portion comprising a female Luer-lock connector attachable to a male Luer-lock connector provided on the drug bottle.

13. The fluid transfer device according to claim 1, said connecting portion comprising a male Luer-lock connector attachable to a female Luer-lock connector provided on the drug bottle.

14. The fluid transfer device according to claim 1, wherein said connecting portion is a separate component attached to said first member before permanent attachment to the drug bottle.

15. The fluid transfer device according to claim 1, wherein said connecting portion is an integral part of the first member.

16. The fluid transfer device according to claim 1, wherein said connecting portion is a separate component comprising a Luer-lock connector attachable to said first member by means of a Luer-lock coupling.

17. The fluid transfer device according to claim 1, wherein said connecting portion is a separate component comprising:

a Luer-lock connector attachable to said first member by means of a Luer-lock coupling;

at least one locking member capable of grasping a bottle neck of the drug bottle and thereby creating a permanent attachment; and

a hollow piercing member capable of penetrating a bottle cap of the drug bottle and thereby extending said fluid passage into the drug bottle.

18. The fluid transfer device according to claim 1, further comprising the drug bottle which contains a fixed dose of a medical substance and which is configured to be attached to the fluid transfer device.

19. The fluid transfer device according to claim 18, said drug bottle further comprising a bottle neck graspable by at least one locking member of said connecting portion and thereby creating a permanent attachment.

20. The fluid transfer device according to claim 18, said drug bottle further comprising a bottle cap pierceable by a piercing member of said fluid transfer device.

21. The fluid transfer device according to claim 18, said drug bottle further comprising a bottle cap for sealing the drug bottle, the bottle cap comprising a second coupling member attachable to a first coupling member of said connecting portion.

22. The fluid transfer device according to claim 18, further comprising a bottle cap sealing said. drug bottle, said bottle cap comprising a second coupling member, wherein a fluid barrier member is provided in a duct extending between an interior of said drug bottle and said second coupling member, said fluid baffler member rupturable by means of an external force that opens said duct.

23. The fluid transfer device according to claim 18, further comprising a bottle cap for sealing said drug bottle, said bottle cap comprising a second coupling member attachable to a first coupling member of said connecting portion, wherein said second coupling member is permanently attached to said drug bottle at least partly by means of an annular capsule member.

24. The fluid transfer device according to claim 18, further comprising a bottle cap for sealing said drug bottle, said bottle cap comprising a male Luer-lock connector able to be attached to a female Luer-lock connector of said connecting portion.

25. The fluid transfer device according to claim 18, further comprising a bottle cap for sealing said drug bottle, said bottle cap comprising a female Luer-lock connector attachable to a male Luer-lock connector of said connecting portion.

26. A method for fluid transfer in an infusion system, said method comprising:

utilizing a fluid transfer device to inject a medical substance from a drug bottle containing a fixed dose of said medical substance into an infusion system via an injection port sealed by a flexible barrier member, said fluid transfer device comprising at least a first member, a hollow needle attached to said first member, and a second member telescopically and retractably displaceable in relation to said first member, said fluid transfer device further comprising a first end, and a second, opposite end having a flexible membrane;

attaching said first end of said fluid transfer device to said drug bottle;

releasably coupling said second end of said fluid transfer device to said injection port while pressing said flexible membrane against said flexible barrier member with a pressure sufficient for creating a double-membrane sealing by said flexible membrane and said flexible barrier member;

creating a fluid passage from said first end of said infusion system by telescopically displacing said first end in a direction towards said second end and thereby allowing said hollow needle to penetrate said flexible membrane and said flexible barrier member while being surrounded by said double-membrane sealing formed by said flexible membrane and flexible barrier membrane;

transferring said fixed dose from said drug bottle into said infusion system by means of creating and subsequently releasing a positive pressure inside said drug bottle; and

displacing said first end away from said second end while said fluid transfer device is connected to said infusion system and said drug bottle.

27. The method for fluid transfer according to claim 26, wherein said injection port is provided on a flexible infusion bag of said infusion system.

28. The method for fluid transfer according to claim 26, wherein said injection port is provided on an infusion fluid line of said infusion system.

29. The method for fluid transfer according to claim 26, further comprising:

creating a double-membrane bayonet coupling between the second end and said injection port.

30. The method for fluid transfer according to claim 26, further comprising:

penetrating a bottle cap of said drug bottle by means of a hollow piercing member in order to extend said fluid passage into said drug bottle; and

grasping a bottle neck of said drug bottle by means of at least one locking member of said fluid transfer device and thereby creating a permanent attachment.

31. The method for fluid transfer according to claim 26, further comprising:

creating the attachments by a Luer-lock coupling.

32. The method for fluid transfer according to claim 26, further comprising:

rupturing a fluid barrier member blocking a duct extending through said bottle cap by an external force when extending said fluid passage into said drug bottle.

33. The method for fluid transfer according to claim 26, further comprising:

utilizing a clamping member for applying an external pressure on a duct extending through said bottle cap and thereby blocking said fluid passage into said drug bottle.

34. The method for fluid transfer according to claim 26, further comprising:

pressing the flexible membrane of said second end against a flexible baffler member of a splice device connected to said infusion system before transferring said fixed dose from said drug bottle into said infusion system.

35. The method for fluid transfer according to claim 26, further comprising:

providing the fluid transfer device with at least one protective cap, and removing the protective cap before creating said fluid passage.

36. A fluid transfer device for temporarily establishing fluid communication between a drug bottle and an infusion fluid container that is adapted for transferring a medical substance from the drug bottle to the infusion fluid container for mixture with infusion fluid container therein and the fluid transfer device is configured to prevent leakage of the medical substance into the ambient environment during both transfer of the medical substance into the infusion fluid container and after disconnect of the fluid transfer device from the infusion fluid container, said fluid transfer device comprising:

a first end including a connecting portion for interconnection with a drug bottle containing a fixed dose of a medical substance;

a second end opposite said first end and configured to be releasably coupled to an injection port of an infusion fluid container that is sealed by a pierceable flexible barrier, said second end of said transfer device having a flexible membrane located to be pressed against the flexible barrier of the injection port when coupled thereto; and

a first member having a hollow needle attached thereto and said first member being telescopically associated with a second member, said first member and second member being displaceable relative to each other to and fro between two end positions, so that upon displacement of said first member in a first direction relative to said second member when said fluid transfer device is coupled to the injection port, said hollow needle pierces said flexible membrane and the flexible barrier thereby creating a fluid passage from said first end into the infusion fluid container with a double-membrane seal around said hollow needle, and upon displacement of said first member relative to said second member in a second direction opposite to the first direction, said hollow needle is withdrawn to a position within said flexible membrane while said fluid transfer device is connected to said infusion fluid container and said drug bottle, thereby enabling disconnection of the fluid transfer device from the infusion fluid container.