Pressure-regulating vial adaptors

• US 9,763,855 B2
• Filed: 07/22/2015
• Issued: 09/19/2017
• Est. Priority Date: 01/23/2013
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Fangrow, Thomas F.
• Primary Examiner(s): Deak, Leslie
• Assistant Examiner(s): WENG, KAI H
• Application Number:
  US14/806,516
• Publication Number:
  US 20150320642A1
• Time in Patent Office: 790 Days
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2075 for external 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: A61J 1/22 with means for metering the amount of fluid
• CPC Class Codes: Y10T 137/9029 With coupling

Abstract

In certain embodiments, a vial adaptor comprises a housing configured to couple the adaptor with a vial, an access channel, a regulator channel, and a regulator assembly. The access channel is configured to facilitate withdrawal of fluid from the vial when the adaptor is coupled to the vial. The regulator channel is configured to facilitate a flow of a regulating fluid from the regulator assembly to compensate for changes in volume of a medical fluid in the vial. In some embodiments, the regulator assembly includes a flexible member configured to expand and contract in accordance with changes in the volume of the medical fluid in the vial. In some embodiments, the flexible member is substantially free to expand and contract. In some embodiments, the flexible member is not partly or completely located in a rigid enclosure.

Claims

1. A medical adaptor capable of coupling with a sealed container, the medical adaptor having a flexible enclosure that deploys from a stored configuration to a deployed configuration, the medical adaptor comprising:

a housing comprising;

a medical connector interface;

an access channel through which medicinal fluid from a sealed container can be removed, the access channel extending between the medical connector interface and a distal access port; and

a regulator channel comprising a distal portion and a proximal portion having a longitudinal axis extending from the distal portion through the proximal portion; and

a regulator assembly in fluid communication with the proximal portion of the regulator channel, the regulator assembly comprising;

a storage region having a storage region width as measured perpendicular to the longitudinal axis of the proximal portion of the regulator channel;

a flexible enclosure in fluid communication with the proximal portion of the regulator channel, the flexible enclosure capable of transitioning between a stored configuration wherein the flexible enclosure is positioned within the storage region and a deployed configuration wherein at least a portion of the flexible enclosure is positioned outside of the storage region, the flexible enclosure having a stored volume when in the stored configuration and a deployed volume when in the deployed configuration, the flexible enclosure having a stored width when in the stored configuration and a deployed width when in the deployed configuration; and

an intake valve in fluid communication with the flexible enclosure and the distal portion of the regulator channel, the intake valve capable of transitioning between an opened configuration and a closed configuration, wherein the intake valve facilitates fluid communication from an ambient environment to an interior of the regulator assembly when the intake valve is in the opened configuration;

wherein the deployed width of the flexible enclosure as measured perpendicular to the longitudinal axis of the proximal portion of the regulator channel is greater than the storage region width, and the deployed volume of the flexible enclosure is greater than the stored volume of the flexible enclosure, and wherein the flexible enclosure deploys from a folded configuration into an unfolded configuration when the flexible enclosure moves from the stored configuration to the deployed configuration.

2. The adaptor of claim 1, wherein the intake valve is flexible.

3. The adaptor of claim 2, wherein the intake valve is circular.

4. The adaptor of claim 1, wherein the valve storage region comprises a valve seat.

5. The adaptor of claim 1, wherein the intake valve is a one-way valve, the intake valve capable of inhibiting outflow of fluid through the intake valve from the interior of the regulator channel to the ambient environment.

6. The adaptor of claim 1, further comprising a filter.

7. The adaptor of claim 6, wherein the filter is a hydrophobic filter.

8. The adaptor of claim 1, further comprising at least one intake port that facilitates fluid communication between the filter and the ambient environment.

9. The adaptor of claim 1, wherein the intake valve is in a deflected configuration when the intake valve is in the closed configuration.

10. The adaptor of claim 1, wherein at least a portion of the intake valve is biased toward the valve seat.

11. The adaptor of claim 1, wherein an orifice of the intake valve is positioned coaxially with at least a portion of the regulator channel.

12. The adaptor of claim 1, further comprising a regulator valve positioned in the regulator channel between the distal portion of the regulator channel and the regulator assembly.

13. The adaptor of claim 12, wherein the regulator valve is configured to transition between an opened and a closed position.

14. The adaptor of claim 12, wherein the regulator valve is configured to open to flow in a first direction at a first required cracking pressure and to open to flow in a second direction at a second required cracking pressure greater than the first required cracking pressure.

15. The adaptor of claim 14, wherein the first direction is away from the flexible enclosure and toward the distal portion of the regulator channel.

16. The adaptor of claim 12, wherein the regulator valve comprises a domed portion having a convex side and a concave side, and wherein the concave side faces the flexible enclosure.

17. The adaptor of claim 1, further comprising an enclosure cover sized and shaped to fit around a radially outward portion of the storage region, the enclosure cover including an outer lip having an outer lip width, wherein the enclosure cover includes an expansion aperture surrounded by the outer lip, and wherein at least a portion of the flexible enclosure passes through the expansion aperture transitions from the contracted configuration to the expanded configuration.

18. The adaptor of claim 1, wherein the flexible enclosure is folded along at least three fold lines when in the folded configuration, and wherein at least one of the fold lines is perpendicular to another one of the fold lines.

19. The adaptor of claim 1, wherein the flexible enclosure is constructed from a stretchable material.

20. A medical adaptor capable of coupling with a sealed container, the medical adaptor having a filter chamber surrounding at least a portion of a regulator assembly channel, the medical adaptor comprising:

a housing comprising;

a medical connector interface;

an access channel extending between the medical connector interface and a distal access port; and

a regulator channel; and

a regulator assembly comprising;

a storage chamber having a storage height and a storage depth and a storage volume;

a filter chamber in fluid communication with an ambient environment, wherein the filter chamber comprises an inner surface of an inner wall, and an outer surface of an outer wall, and wherein the filter chamber surrounds at least a portion of the regulator assembly channel;

a flexible enclosure capable of fluid communication with the proximal regulator channel, the flexible enclosure capable of transitioning between a contracted configuration and an expanded configuration;

an intake valve in fluid communication with the flexible enclosure and the regulator channel, the intake valve capable of transitioning between an opened configuration and a closed configuration, the intake valve comprising a flexible member comprising an inner orifice, the inner orifice generally surrounding at least a portion of a fluid path between the flexible enclosure and the proximal regulator passageway when the intake valve is in the closed configuration, wherein the intake valve facilitates fluid communication between an interior of the regulator assembly and the filter chamber when the intake valve is in the opened configuration; and

a filter positioned within the filter chamber in a region between the inner surface of the filter chamber and the outer surface of the filter chamber.

21. The adaptor of claim 20, wherein the inner orifice of the flexible member is circular.

22. The adaptor of claim 20, further comprising a circular valve seat.

23. The adaptor of claim 20, wherein the intake valve is a one-way valve, the intake valve capable of inhibiting outflow of fluid through the intake valve from the interior of the regulator assembly to the ambient environment.

24. The adaptor of claim 20, wherein the filter is a hydrophobic filter.

25. The adaptor of claim 20, wherein the filter is an antimicrobial filter.

26. The adaptor of claim 20, wherein the regulator assembly includes at least one intake port, the intake port facilitating fluid communication between the filter chamber and the ambient environment.

27. The adaptor of claim 20, wherein the flexible member is in a deflected configuration when the intake valve is in the closed configuration.

28. The adaptor of claim 22, wherein the flexible member is biased toward the valve seat.