Pressure-regulating vial adaptors

• US 9,615,997 B2
• Filed: 07/22/2015
• Issued: 04/11/2017
• 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): Laurenzi, Mark A
• Assistant Examiner(s): Schmid, Andrew
• Application Number:
  US14/806,520
• Publication Number:
  US 20150320641A1
• Time in Patent Office: 629 Days
• Field of Search: 141 27, 141311 R, 141312, 141318, 141319, 141321, 141322, 141326, 141330, 141346, 141351, 141352, 141353, 141357, 141369, 141370, 141372, 141383, 141384, 141385, 141386, 604411, 604415
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2037 having valve means
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2072 for internal venting
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2082 for gas filtration
• 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
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: Y10T 137/9138 Flexible

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 comprising:

a housing comprising;

a medical connector interface;

an access channel capable of conveying 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 regulator assembly comprising;

a regulator nest 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 regulator nest and a deployed configuration wherein at least a portion of the flexible enclosure is positioned outside of the regulator nest, 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 that is different from the stored width;

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

2. The adaptor of claim 1, wherein the deployed volume is greater than or equal to about 3,000% of the storage volume of the regulator nest.

3. The adaptor of claim 1, wherein the flexible enclosure is folded along at least four fold lines when in the stored configuration.

4. The adaptor of claim 1, wherein the medical adaptor is capable of preventing release of vapors or other harmful materials from the sealed container when the medical adaptor is coupled with the sealed container.

5. The adaptor of claim 1, wherein the deployed width of the flexible enclosure is greater than the stored width of the flexible enclosure.

6. The adaptor of claim 5, wherein the deployed width is greater than or equal to about 250% of the stored width.

7. The adaptor of claim 1, wherein the storage volume has a cylindrical shape.

8. The adaptor of claim 1, wherein the flexible enclosure is constructed from a flexible material with little or no stretchability.

9. The adaptor of claim 1, wherein the regulator nest has a storage width, and wherein the storage width is less than a distance between the medical connector interface and the distal regulator aperture.

10. The adaptor of claim 1, wherein the flexible enclosure is folded along multiple fold lines when in the stored configuration.

11. The adaptor of claim 10, wherein at least two of the fold lines are non-parallel with each other.