Pressure-regulating devices for transferring medicinal fluid

• US 10,117,807 B2
• Filed: 04/10/2017
• Issued: 11/06/2018
• 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): Maust, Timothy L
• Assistant Examiner(s): Kelly, Timothy P
• Application Number:
  US15/483,446
• Publication Number:
  US 20170312176A1
• Time in Patent Office: 575 Days
• 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 having a proximal end;

a piercing member having a distal end configured to penetrate a septum of a vial adaptor when the distal end of the piercing member is pushed against the septum;

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 extending between a proximal regulator passageway and a distal regulator aperture; and

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

a storage region having a storage volume and a width as measured parallel to a length of the piercing member; and

a flexible enclosure in fluid communication with the proximal passageway, the flexible enclosure capable of transitioning between a contracted configuration wherein the flexible enclosure is positioned within the storage chamber and an expanded configuration wherein at least a portion of the flexible enclosure is positioned outside of the storage chamber, the flexible enclosure having a contracted volume when in the contracted configuration and an expanded volume when in the expanded configuration, the flexible enclosure having a contracted width when in the contracted configuration and an expanded width when in the expanded configuration, the expanded width being different from the contracted width;

wherein the width of the storage region is less than or equal to a distance between the proximal end of the medical connector interface and the distal end of the piercing member.

2. The medical adaptor of claim 1, wherein the width of the storage region is less than a distance between the proximal end of the medical connector interface and the distal regulator aperture.

3. The medical adaptor of claim 1, wherein the adaptor is configured to inhibit or prevent release of vapors or other harmful materials from the vial to a surrounding environment when the medical adaptor is coupled with the vial.

4. The medical adaptor of claim 1, wherein at least three layers of the flexible enclosure are positioned between the proximal regulator passageway and a surrounding environment when the flexible enclosure is in the contracted configuration.

5. The medical adaptor of claim 1, wherein the regulator assembly includes one or more fixation apertures, wherein the regulator assembly includes a regulator nest having one or more fixation members configured to engage with the one or more fixation apertures, and wherein the storage chamber is positioned within the regulator nest.

6. The medical adaptor of claim 5, wherein the regulator nest is configured to releasably connect to the one or more fixation apertures.

7. The medical adaptor of claim 1, wherein the medical adaptor includes a valve configured to selectively inhibit fluid from passing through the valve from the vial to the flexible enclosure when the medical adaptor is coupled with the vial.

8. The medical adaptor of claim 7, wherein the valve comprises a dome valve positioned within the regulator channel, wherein a concave side of the dome valve faces the flexible enclosure, and wherein a convex side of the dome valve faces away from the flexible enclosure.

9. The medical adaptor of claim 7, wherein the valve is configured to open and close in response to the effect of gravity upon the valve.