System for Closed Transfer of Fluids

• US 20140261877A1
• Filed: 03/11/2014
• Published: 09/18/2014
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Ivosevic, Milan, Marici, Paul Paia
• Granted Patent: US 9,597,260 B2
• Time in Patent Office: Days
• US Class Current: 141/27
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2048 Connecting means
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2065 having aligning and guiding means
• CPC Class Codes: A61J 1/2072 for internal venting
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2039/1027 Quick-acting type connectors
• CPC Class Codes: A61M 2039/1044 Verifying the connection, e.g. audible feedback, tactile feedback, visual feedback, using external light sources
• CPC Class Codes: A61M 2039/1072 with a septum present in the connector
• CPC Class Codes: A61M 39/12 for joining a flexible tube to a rigid attachment
• CPC Class Codes: A61M 39/14 for connecting tubes having sealed ends needle sets A61M5/162; having valves closing automatically on disconnection of line A61M39/26
• CPC Class Codes: Y10T 29/49217 by elastic joining

Abstract

A system for the closed transfer of fluids that provides substantially leak-proof sealing and pressure equalization during engagement of a cannula with a vial, during transfer of a substance from a vial chamber to a barrel chamber via the cannula, and during disengagement of the cannula from the vial is disclosed. The leak-proof sealing of the system substantially prevents leakage of both air and liquid during use of the system. The system of the present disclosure also permits pressure equalization between a vial and the system when the system is attached to the vial. The system is compatible with a needle and syringe assembly for accessing a medication contained within a vial for administering the medication to a patient.

Claims

1. A system comprising:

a cannula attachable to a first container having a first chamber such that the cannula is in fluid communication with the first chamber;

a syringe adapter having a housing and a cannula seal comprising a resilient sleeve, the cannula seal enclosing at least a portion of the cannula, the cannula seal disposed within the housing, the housing including a first connection element; and

a second container adapter attachable to a second container having a second chamber, the second container adapter having a second container seal and a second connection element,

wherein with the first connection element of the syringe adapter engaged with the second connection element of the second container adapter, the syringe adapter is secured to the second container adapter.

2. The system of claim 1, wherein the second container adapter comprises a pressure equalization system having a toroidal expandable balloon.

3. The system of claim 2, wherein the second container adapter includes a second container adapter housing and a portion of the toroidal expandable balloon is not covered by the second container adapter housing.

4. The system of claim 2, wherein a portion of the toroidal expandable balloon can expand in an axial direction.

5. The system of claim 1, wherein the cannula seal and the second container seal provide substantially leak-proof sealing during engagement of the cannula with the second container, during transfer of a first substance from the second chamber of the second container to the first chamber of the first container via the cannula, and during disengagement of the cannula from the second container.

6. The system of claim 1, wherein the syringe adapter includes an intake air filter.

7. The system of claim 1, wherein the first connection element comprises a first projecting element and the second connection element comprises a first connection channel, a first disconnection channel, and a first securement element disposed between the first connection channel and the first disconnection channel, the first connection channel distinct from the first disconnection channel, wherein with the first projecting element engaged with the first securement element, the syringe adapter is secured to the second container adapter.

8. The system of claim 1, wherein the first container is a syringe barrel.

9. The system of claim 1, wherein the second container is a vial.

33. The system of claim 5, wherein the vial adapter further comprises a plurality of stabilizing ribs spaced around a periphery of the wall of the vial adapter.

10. A system comprising:

a first container defining a first chamber;

a cannula attachable to the first container such that the cannula is in fluid communication with the first chamber;

a syringe adapter having a housing and a cannula seal comprising a resilient sleeve, the cannula seal enclosing at least a portion of the cannula, the cannula seal disposed within the housing, the housing including a first connection element;

a second container defining a second chamber;

a second container septum engaged with the second container to seal the second chamber; and

a second container adapter attachable to the second container, the second container adapter having a second container seal and a second connection element, and

wherein with the first connection element of the syringe adapter engaged with the second connection element of the second container adapter, the syringe adapter is secured to the second container adapter.

11. The system of claim 10, wherein the cannula seal, the second container seal, and the second container septum provide substantially leak-proof sealing during engagement of the cannula with the second container, during transfer of a first substance from the second chamber of the second container to the first chamber of the first container via the cannula, and during disengagement of the cannula from the second container.

12. The system of claim 10, wherein the second container adapter includes a pressure equalization system comprising a toroidal expandable balloon.

13. The system of claim 12, wherein the second container adapter includes a second container adapter housing and a portion of the toroidal expandable balloon is not covered by the second container adapter housing.

14. The system of claim 12, wherein a portion of the toroidal expandable balloon can expand in an axial direction.

15. The system of claim 10, wherein the syringe adapter includes an intake air filter.

16. The system of claim 10, wherein the first connection element comprises a first projecting element and the second connection element comprises a first connection channel, a first disconnection channel, and a first securement element disposed between the first connection channel and the first disconnection channel, the first connection channel distinct from the first disconnection channel, wherein with the first projecting element engaged with the first securement element, the syringe adapter is secured to the second container adapter.

17. The system of claim 10, wherein the first container is a syringe barrel.

18. The system of claim 10, wherein the second container is a vial.

19. A vial adapter comprising:

a vial access system comprising;

a vial access housing having a first end and a second end, the vial access housing including a seal membrane;

a first connection element disposed at the first end of the vial access housing, the first connection element engageable with a second connection element of a syringe adapter to secure the vial adapter to the syringe adapter;

a plurality of vial grip members disposed at the second end of the vial access housing, the plurality of vial grip members attachable to a vial to secure the vial adapter to the vial; and

a spike disposed at the second end of the vial access housing, the spike attachable to the vial such that the spike is in fluid communication with a chamber of the vial;

a pressure equalization system attachable to the vial access system, the pressure equalization system comprising;

a pressure equalization housing; and

a toroidal expandable balloon, wherein a portion of the toroidal expandable balloon is not covered by the pressure equalization housing, wherein with the vial adapter attached to the vial, the pressure equalization system is in fluid communication with the vial.

20. The vial adapter of claim 19, wherein the vial adapter further comprises a vial sleeve seal disposed over the spike, the vial sleeve seal providing a seal between the vial adapter and the vial with the spike attached to the vial.

21. The vial adapter of claim 19, wherein a portion of the toroidal expandable balloon can expand in an axial direction.

22. The vial adapter of claim 19, wherein the pressure equalization housing includes a filter.

23. A syringe adapter comprising:

a cannula attachable to a first container having a first chamber such that the cannula is in fluid communication with the first chamber of the first container;

a syringe adapter housing including a first connection element, the first connection element engageable with a second connection element of a vial adapter to secure the syringe adapter to the vial adapter;

a cannula seal comprising a resilient sleeve enclosing at least a portion of the cannula, the cannula seal disposed within the syringe adapter housing;

a spring disposed over the cannula such that the spring is positioned between the cannula and the cannula seal, wherein the spring provides a biasing force; and

an intake air filter disposed within the syringe adapter housing.

24. The syringe adapter of claim 23, wherein the syringe adapter housing includes a first end, a second end, and a sidewall extending therebetween, the sidewall having an exterior surface and an interior surface, the interior surface of the sidewall having the first connection element.

25. The syringe adapter of claim 23, further comprising a gliding ring positioned between the cannula seal and the housing.

26. The syringe adapter of claim 25, wherein the gliding ring is secured to a distal end of the cannula seal.

27. A system comprising:

a vial adapter having a first end, a second end, and a wall extending therebetween, the wall defining an exterior profile, the vial adapter having a vial seal, the vial adapter attachable to a vial; and

a packaging member having a proximal end, a distal end, and a sidewall extending therebetween and defining an interior, the sidewall of the packaging member defining an interior profile, the interior of the packaging member sized and adapted to receive the vial adapter therein, and the interior profile of the packaging member sized and shaped to substantially correspond to the exterior profile of the vial adapter.

28. The system of claim 27, further comprising a sealing member removably attachable to the proximal end of the packaging member, wherein with the vial adapter received within the interior of the packaging member and the sealing member attached to the packaging member, the sealing member seals the vial adapter within the packaging member.

29. The system of claim 27, wherein the sidewall of the packaging member comprises a cylindrical portion, a tapered portion, and a bottom arcuate portion.

30. The system of claim 29, wherein the vial adapter includes a tapered exterior wall portion.

31. The system of claim 30, wherein with the vial adapter received within the interior of the packaging member, the tapered portion of the packaging member and the tapered exterior wall portion of the vial adapter form complementary locking tapers.

32. The system of claim 30, wherein the interior profile of the packaging member is sized and shaped to substantially correspond to the exterior profile of the vial adapter such that, with the vial adapter received within the interior of the packaging member, the vial adapter is secured within the packaging member by an interference fit.