Device and method for mixing medical fluids

• US 20030191445A1
• Filed: 04/08/2002
• Published: 10/09/2003
• Est. Priority Date: 04/08/2002
• Status: Active Grant

• Current Assignee: Carmel Pharma AB (Becton, Dickinson & Co)
• Original Assignee: Carmel Pharma AB (Becton, Dickinson & Co)
• Inventors: Andreasson, Kiell, Wallen, Claes
• Granted Patent: US 7,744,581 B2
• Time in Patent Office: Days
• US Class Current: 604/411
• 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 1/2017 having three or more piercing ends
• CPC Class Codes: A61J 1/2058 having multiple connecting ports
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2202/049 Toxic
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• CPC Class Codes: A61M 39/221 Frangible or pierceable closures within tubing A61M39/14 takes precedence; frangible closures for containers A61J1/14
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• 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 device and method for mixing medical fluids is disclosed. The device has an inlet port, an injection port, an outlet port, a first duct between the injection port and the inlet port, and a second duct between the inlet port and the outlet port. The injection port is sealed by a fluid-proof membrane which can be penetrated by an injection needle. The device further includes at least a first portion made of a first material and a second portion made of a second, substantially more resilient material, wherein the inlet port and the injection port are included in the first portion and the outlet port is included in the second portion, and the first and second portions are attached to each other by means of a combined friction coupling and snap connection.

Claims

1. A device for mixing medical fluids, said device comprising

an inlet port for receiving at least a first medical fluid,

an injection port for injection of a second medical fluid,

an outlet port for exit of a mixed flow of said first and second medical fluids,

a first duct extending between said injection port and said inlet port, and

a second duct extending between said inlet port and said outlet port,

said injection port being sealed by a fluid-proof membrane which can be penetrated by an injection needle when injecting said second medical fluid,

at least a first portion made of a first material and a second portion made of a second material, wherein said second material is substantially more resilient than said first material, and said inlet port and said injection port are included in said first portion and said outlet port is included in said second portion

wherein said first and second portions are attached to each other by means of a combined friction coupling and snap connection providing a first retention force.

2. The device according to claim 1, said first portion further comprising an annular, tapering groove and said second portion further comprising an annular, tapering rim, said first portion comprising a first snap member and said second portion comprising a second snap member,

wherein said groove is designed and arranged for snugly accommodating said rim in order to provide part of said first retention force, and

wherein said first snap member is designed and arranged for interacting with said second snap member in order to provide the remainder of said first retention force.

3. The device according to claim 1, said outlet port further comprising a tube of said resilient second material, wherein said tube is designed and arranged for snugly accommodating a piercing member of an infusion line in order to retain said piercing member with a second retention force.

4. The device according to claim 1, said outlet port further comprising a tube of said resilient second material, said tube having a first diameter at a first end facing towards said first portion and a second diameter at a second end facing towards said outlet port wherein said tube is designed and arranged with said second diameter being smaller than said first diameter in order to allow leakage-proof insertion of a piercing member of an infusion line.

5. The device according to claim 1, said first portion further comprising an annular, tapering groove, said second portion further comprising an annular, tapering rim, and said outlet port further comprising a tube of said resilient second material,

wherein said groove is designed and arranged for retaining said rim with a first retention force and said tube is designed and arranged for retaining a piercing member of an infusion line with a second retention force in such a way that said first and second retention forces both are larger than 15 N in 30 seconds and said first retention force is larger than said second retention force.

6. The device according to claim 1, wherein said outlet port is sealed by a barrier member which is designed and arranged to be ruptured by a piercing member of an infusion line in order to open a passage for said mixed flow from said inlet port to said outlet port

7. The device according to claim 1, wherein said first portion has been injection-molded from a thermoplastic polymer material.

8. The device according to claim 1, wherein said first portion is made of polypropylene, polycarbonate or ABS-polymer.

9. The device according to claim 1, wherein said second portion is made of an elastomeric polymer material or a synthetic rubber material.

10. The device according to claim 1, said inlet port further comprising a rigid spike member for penetrating a fluid-proof septum of a fluid container containing said first medical fluid.

11. The device according to claim 1, said first portion further comprising a locking member for permanent coupling to a fluid transfer port of a fluid container containing said first medical fluid.

12. The device according to claim 1, said inlet port further comprising a rigid spike member having at least one barb member for engaging an internal surface of a fluid transfer port of a fluid container containing said first medical fluid.

13. The device according to claim 1, said inlet port further comprising a rigid spike member having at least one hook member for engaging an external surface of a fluid transfer port of a fluid container containing said first medical fluid.

14. The device according to claim 1, said outlet port being sealed by a barrier member which is integrated with and made of the same material as said outlet port.

15. The device according to claim 1, wherein said outlet port is sealed by a barrier member which is designed and arranged to be ruptured by a piercing member of an additional spike member in order to enable passage of said mixed flow from said Inlet port via said second duct through said additional spike member into an infusion line.

16. The device according to claim 1, wherein said fluid-proof membrane of said injection port is designed and arranged to be penetrated by said injection needle, wherein said injection needle is provided by a fluid transfer device which can be connected to a second medical fluid-reservoir at one end and which exhibits an additional fluid-proof membrane at the other end which is designed and arranged to be included in a double-membrane bayonet coupling with said injection port.

17. The device according to claim 1, characterized in that the device exhibits a base member for allowing the device to rest in a horizontal position before infusion.

18. The device according to claim 1, said device further comprising a handle grip for facilitating connection of said device to a fluid container.

19. The device according to claim 1, said second portion further comprising a cap member for preventing contamination which can be opened in order to access said outlet port.

20. The device according to claim 1, wherein said device has less than five components attached to each other.

21. The device according to claim 1, said device only comprising said fluid-proof membrane, said first portion, said second portion, and a removable hood for preventing contamination of said inlet port.

22. The device according to claim 1, wherein said second portion of said device is attached to a drip chamber of an infusion line

29. The method according to claim 2, the method further comprising the step of:

rupturing a barrier member sealing said outlet port by means of a piercing member of an infusion line.

23. A method for enabling mixing of medical fluids, said method comprising the steps of:

providing a mixing device exhibiting an inlet port, an injection port and an outlet port,

coupling said inlet port to a fluid transfer port of a fluid container containing a first medical fluid,

connecting a fluid transfer device having an injection needle to said injection port by means of a double-membrane bayonet coupling,

penetrating fluid-proof membranes included in said double-membrane bayonet coupling by means of said injection needle,

injecting a second medical fluid from a second medical fluid-reservoir connected to said fluid transfer device into said first medical fluid,

passing a mixed flow of said first and second medical fluids through said outlet port into an infusion line, and

providing a combined friction coupling and snap connection in said device between a first portion which is made of a first material and exhibits said inlet port and said injection port and a second portion which is made of a second material being substantially more resilient than said first material and which exhibits said outlet port.

24. The method according to claim 23, the method further comprising the step of:

inserting an annular, tapering rim of said second portion into an annular, tapering groove of said first portion in order to achieve a snug fit providing a friction coupling between said first and second portions.

25. The method according to claim 23, the method further comprising the step of:

introducing a male snap member into a female snap member in order create a snap connection between said first and second portions.

26. The method according to claim 23, the method further comprising the step of:

insert a piercing member of said infusion line into a tube of said second portion in order to achieve a snug fit.

27. The method according to claim 23, the method further comprising the step of:

providing said second portion exhibiting a tube having a first diameter at a first end facing towards said first portion and a second diameter at a second end facing towards said outlet port,

selecting said second diameter to be smaller than said first diameter, and inserting a piercing member of said infusion line into said tube from said second end.

28. The method according to claim 23, the method further comprising the step of:

creating a first retention force between an annular, tapering groove of said first portion and an annular, tapering rim of said second portion,

creating a second retention force between a tube of said second portion and a piercing member of an infusion line, and

selecting said first and second retention forces to be larger that 15 N in 30 seconds and said first retention force to be larger than said second retention force.

30. The method according to claim 23, the method further comprising the step of:

providing the first portion as an injection-molded component made of a thermoplastic polymer material.

31. The method according to claim 23, the method further comprising the step of:

providing the first portion as a component made of polypropylene, polycarbonate or ABS-polymer.

32. The method according to claim 23, the method further comprising the step of:

designing the second portion as a component made of an elastomeric polymer material or a synthetic rubber material.

33. The method according to claim 23, the method further comprising the step of:

designing the inlet port as a rigid spike member and to penetrate a fluid-proof septum of a fluid container containing staid first medical fluid by means of said spike member.

34. The method according to claim 23, the method further comprising the step of:

utilizing a locking member provided on said first portion in order to achieve a permanent coupling to a fluid transfer port of a fluid container containing said first medical fluid.

35. The method according to claim 23, the method further comprising the step of:

engaging an internal surface of a fluid transfer port of a fluid container containing said first medical fluid by means of at least one barb member of a rigid spike member of said inlet port.

36. The method according to claim 23, the method further comprising the step of:

engaging an external surface of a fluid transfer port of a fluid container containing said first medical fluid by means of at least one hook member of a rigid spike member of said inlet port.

37. The method according to claim 23, the method further comprising the step of:

providing the outlet port with an integrated barrier member made of the same material as said outlet port.

38. The method according to claim 23, the method further comprising the step of:

providing the outlet port with a barrier member, and to rupture said barrier member by means of a piercing member in form of an additional spike member of said infusion line.

39. The method according to claim 23, the method further comprising the step of:

resting the device in a horizontal position on a base member of said device.

40. The method according to claim 23, the method further comprising the step of:

handling said device by means of a handle grip when connecting said device to a fluid container.

41. The method according to claim 23, the method further comprising the step of:

opening a contamination-preventing cap member of said device in order to access said outlet port.

42. The method according to claim 23, the method further comprising the step of:

assembling less than five components before using said device.

43. The method according to claim 23, the method further comprising the step of:

assembling the device only from said fluid-proof membrane, said first portion, said second portion and a removable hood for preventing contamination of said inlet port.

44. The method according to claim 25, the method further comprising the step of:

removing a contamination-preventing hood from said inlet port before using said device.

45. The method according to claim 25, the method further comprising the step of:

providing said second portion with a drip chamber attached thereto.