PRESSURE-REGULATING VIAL ADAPTORS

• US 20140230932A1
• Filed: 01/22/2014
• Published: 08/21/2014
• Est. Priority Date: 01/23/2013
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Fangrow, Thomas F.
• Granted Patent: US 9,089,475 B2
• Time in Patent Office: Days
• US Class Current: 137/798
• 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. (canceled)

2. A medical adaptor capable of coupling with a sealed container, the medical adaptor having a flexible enclosure that deploys through an expansion aperture when the flexible enclosure moves from a stored configuration to a deployed configuration, the medical adaptor comprising:

a housing comprising;

a medical connector interface;

an access channel capable of removing medicinal fluid from a sealed container and extending between the medical connector interface and a distal access port; and

a regulator channel comprising a distal passageway, a regulator valve, and a proximal passageway, the distal passageway extending from the regulator valve to a distal regulator aperture; and

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

a storage chamber having a storage volume and an expansion aperture, the expansion aperture having an expansion aperture width;

a flexible enclosure in fluid communication with the proximal passageway, the flexible enclosure capable of transitioning between a stored configuration wherein the flexible enclosure is positioned within the storage chamber and a deployed configuration wherein at least a portion of the flexible enclosure is positioned outside of the storage chamber, 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 regulator aperture, 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 at least a portion of the flexible enclosure passes through the expansion aperture when the flexible enclosure transitions from the stored configuration to the deployed configuration, wherein the stored width of the flexible enclosure is greater than the expansion aperture width, and wherein the flexible enclosure deploys from a folded configuration through the expansion aperture into an unfolded configuration when the flexible enclosure moves from the stored configuration to the deployed configuration.

3. A medical adaptor capable of coupling with a sealed container and having an intake valve comprising a valve seat and a generally annular valve member, the medical adaptor comprising:

a housing comprising;

a medical connector interface;

an access channel capable of removing medicinal fluid from a sealed container and extending between the medical connector interface and a distal access port; and

a regulator channel in fluid communication with a distal regulator aperture and capable of carrying a regulating fluid therein; and

a regulator assembly capable of fluid communication with the regulator channel, the regulator assembly comprising;

a regulator assembly channel;

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

a flexible enclosure in fluid communication with the regulator assembly channel and capable of fluid communication with the regulator channel, the flexible enclosure capable of transitioning between a contracted configuration and an expanded configuration, the flexible enclosure having a contracted volume when in the contracted configuration and an expanded volume when in the expanded configuration;

an intake valve in fluid communication with the flexible enclosure and capable of fluid communication with the regulator channel, the intake valve capable of transitioning between an opened configuration and a closed configuration, the intake valve comprising a valve seat and a generally annular valve member, the valve seat comprising an inner width and an outer width, the valve member comprising an inner perimeter forming an orifice with an orifice width smaller than the outer width of the valve seat, the valve member engaging with the valve seat in a sealing manner when the intake valve is in the closed configuration, the valve member facilitating inflow of air from an ambient environment into the regulator assembly channel when the intake valve is in the opened configuration, wherein the inflow of air occurs between the inner perimeter of the valve member and the valve seat;

a filter chamber in fluid communication with the interior of the regulator assembly when the intake valve is in the opened configuration, the filter chamber comprising an inner wall comprising an inner cross-section and an outer wall comprising an outer cross-section, the filter chamber surrounding at least a portion of the regulator assembly channel; and

a filter positioned within the filter chamber and filling a space between the inner cross-section of the filter chamber and the outer cross-section of the filter chamber;

wherein the inner cross-section of the filter chamber is at least partially bounded by the outer width of the valve seat, and wherein the inner width of the valve seat comprises at least a portion of the regulator assembly channel.

4. The adaptor of claim 3, wherein the valve member is flexible.

5. The adaptor of claim 3, wherein the orifice of the valve member is circular.

6. The adaptor of claim 3, wherein the valve seat is circular.

7. The adaptor of claim 3, 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 interior of the regulator assembly to the ambient environment.

8. The adaptor of claim 3, wherein the filter is a hydrophobic filter.

9. The adaptor of claim 3, wherein the filter is an antimicrobial filter.

10. The adaptor of claim 3, wherein the regulator assembly includes at least one intake port, the intake port facilitating fluid communication between the filter chamber and the ambient environment, the intake port positioned between the orifice and the medical connector interface.

11. The adaptor of claim 3, wherein the valve member is in a deflected configuration when the intake valve is in the closed configuration.

12. The adaptor of claim 3, wherein at least a portion of the valve member is biased toward the valve seat.

13. The adaptor of claim 3, wherein the valve member is positioned coaxially with at least a portion of the regulator assembly channel.

14. 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 capable of removing medicinal fluid extending between the medical connector interface and a distal access port; and

a regulator channel comprising a distal regulator passageway, a regulator valve, and a proximal regulator passageway; and

a regulator assembly comprising;

a regulator interface comprising a regulator assembly channel and capable of fluid communication with the proximal regulator passageway;

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 passageway, 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 proximal regulator passageway when the regulator interface is connected to the proximal regulator aperture, 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 forming 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 and in a region between the inner surface of the filter chamber and the outer surface of the filter chamber.

15. The adaptor of claim 14, wherein the inner orifice of the flexible member is circular.

16. The adaptor of claim 14, wherein the valve seat is circular.

17. The adaptor of claim 14, 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 interior of the regulator assembly to the ambient environment.

18. The adaptor of claim 14, wherein the filter is a hydrophobic filter.

19. The adaptor of claim 14, wherein the filter is an antimicrobial filter.

20. The adaptor of claim 14, wherein the regulator assembly includes at least one intake port, the intake port facilitating fluid communication between the filter chamber and the ambient environment, the intake port positioned between the inner orifice and the medical connector interface.

21. The adaptor of claim 14, wherein the flexible member is in a deflected configuration when the intake valve is in the closed configuration.

22. The adaptor of claim 14, wherein the flexible member is biased toward a valve seat.

23. The adaptor of claim 14, wherein the flexible member is positioned coaxially with at least a portion of the regulator assembly channel.

24. A medical adaptor capable of coupling with a sealed container, the medical adaptor comprising:

a housing comprising;

a medical connector interface;

an access channel capable of removing medicinal fluid from a sealed container and extending between the medical connector interface and a distal access port; and

a regulator channel comprising a distal passageway, a regulator valve, and a proximal passageway, the distal passageway extending from the regulator valve to a distal regulator aperture; and

a regulator assembly in fluid communication with the proximal passageway, the regulatory assembly comprising;

a storage chamber having a storage volume; and

a flexible enclosure in fluid communication with the proximal passageway, the flexible enclosure capable of transitioning between a stored configuration wherein the flexible enclosure is positioned within the storage chamber and a deployed configuration wherein at least a portion of the flexible enclosure is positioned outside of the storage chamber, 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 the in the deployed configuration;

wherein the deployed volume of the flexible enclosure is at least 500% greater than the storage volume of the storage chamber.