Pressure-regulating vial adaptors

• US 10,201,476 B2
• Filed: 12/19/2016
• Issued: 02/12/2019
• Est. Priority Date: 06/20/2014
• Status: Active Grant

• Current Assignee: ICU Medical Incorporated
• Original Assignee: ICU Medical Incorporated
• Inventors: Fangrow, Thomas F.
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US15/384,078
• Publication Number:
  US 20170095404A1
• Time in Patent Office: 785 Days
• Field of Search: 604406
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1456 using liquid filters
• 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 1/2058 having multiple connecting ports
• CPC Class Codes: A61J 1/2075 for external venting
• CPC Class Codes: A61J 1/2082 for gas filtration
• CPC Class Codes: A61J 1/2086 for fluid filtration
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents

Abstract

According to some embodiments of the present disclosure, an adaptor configured to couple with a sealed vial can include a connector interface. The adaptor can include one or more access channels (e.g., passages). In some cases the one or more access channels are in fluid communication with the connector interface. The adaptor can include a piercing member. The piercing member can include a regulator channel. The adaptor can include a regulator assembly. The regulator assembly can include a first regulator inlet. In some cases, the regulator includes a second regulator inlet. One or more of the first and second regulator inlets can include a filter configured to filter fluid passing into and/or out of the respective regulator inlets. One or more valves can be positioned between the first and/or second regulator inlets and the piercing member.

Claims

1. An adaptor configured to couple with a sealed vial, the adaptor comprising:

a connector interface;

an access channel in fluid communication with the connector interface;

a regulator assembly comprising;

a first regulator inlet in fluid communication with an ambient environment surrounding the adaptor;

a first regulator lumen;

a second regulator inlet in fluid communication with the ambient environment;

a second regulator lumen;

a first filter capable of fluid communication with the first regulator lumen and configured to filter fluid passing into the first regulator lumen;

a second filter in fluid communication with the second regulator lumen and configured to filter fluid passing from the second regulator lumen and into the ambient environment; and

a regulator valve in fluid communication with the first regulator lumen, the regulator valve configured to permit passage of fluid from the ambient environment into the first regulator lumen, the regulator valve further configured to prevent passage of fluid from within the vial to the first filter, the regulator valve comprising a valve stem and a flap portion;

a piercing member comprising a proximal end and a distal end, the distal end comprising a piercing tip; and

a regulator channel positioned at least partially within the piercing member and comprising a first regulator channel opening in fluid communication with the first regulator lumen,

wherein the regulator assembly is configured to permit passage of fluid from the second regulator lumen to exit the adaptor and into the ambient environment.

2. The combination of the adaptor of claim 1 and the sealed vial.

3. The adaptor of claim 1, wherein the flap portion of the regulator valve comprises a concave side and a convex side.

4. The adaptor of claim 1, wherein the first regulator lumen and the second regulator lumen are in fluid communication with each other.

5. The adaptor of claim 1, wherein the regulator valve is positioned in a plug portion that is inserted into the first regulator lumen.

6. The adaptor of claim 5, wherein the plug portion is flexible.

7. The adaptor of claim 6, wherein the plug portion is retained within the first regulator lumen by a friction fit.

8. The adaptor of claim 6, wherein a cap portion limits the extent to which the plug portion is inserted into the regulator lumen.

9. The adaptor of claim 8, wherein the first filter is positioned in the plug portion.

10. The adaptor of claim 1, wherein the first filter is positioned within the first regulator lumen.

11. The adaptor of claim 10, wherein the second filter is positioned within the second regulator lumen.

12. The adaptor of claim 1, wherein the first and second filters are positioned along a common line that is generally perpendicular to the regulator channel.

13. The adaptor of claim 12, wherein the regulator valve is positioned along the common line.

14. A method of manufacturing a vial adaptor comprising the steps of:

providing a connector interface;

providing an access channel in fluid communication with the connector interface;

providing a regulator assembly comprising;

a first regulator inlet in fluid communication with an ambient environment surrounding the adaptor;

a second regulator inlet in fluid communication with the ambient environment;

a first filter configured to filter fluid passing into the vial adaptor;

a second filter configured to filter fluid passing from the vial adaptor into the ambient environment; and

a regulator valve configured to permit passage of fluid from the ambient environment into the vial adaptor, the regulator valve further configured to inhibit passage of fluid from within the vial to the first filter, the regulator valve comprising a valve stem and a flap portion,

wherein the regulator assembly is configured to permit passage of fluid from the vial adaptor to exit the adaptor and into the ambient environment;

providing a piercing member comprising a proximal end and a distal end, the distal end comprising a piercing tip; and

providing a regulator channel positioned at least partially within the piercing member and comprising a first regulator channel opening, the regulator channel being in fluid communication with the second filter and the regulator valve.

15. The method of claim 14, in which the first and second regulator inlets are provided along a common line that is generally perpendicular to the regulator channel.

16. The method of claim 15, in which the regulator valve is provided along the common line.

17. The method of claim 14, wherein the regulator valve is configured to prevent passage of fluid from within the vial to the first filter.

18. The method of claim 14, wherein the flap portion of the regulator valve has a concave side and a convex side.

19. An adaptor configured to couple with a sealed vial, the adaptor comprising:

a connector interface;

an access channel in fluid communication with the connector interface;

a regulator assembly comprising;

a first regulator inlet in fluid communication with an ambient environment surrounding the adaptor;

a first regulator lumen;

a second regulator inlet in fluid communication with the ambient environment;

a second regulator lumen;

a first filter capable of fluid communication with the first regulator lumen and configured to filter fluid passing into the first regulator lumen;

a second filter in fluid communication with the second regulator lumen and configured to filter fluid passing from the second regulator lumen and into the ambient environment; and

a regulator valve in fluid communication with the first regulator lumen, the regulator valve configured to permit passage of fluid from the ambient environment into the first regulator lumen, and the regulator valve configured to prevent passage of fluid from within the vial to the first filter, the regulator valve and the first filter positioned in a plug portion configured to couple with the first regulator lumen;

a piercing member comprising a proximal end and a distal end, the distal end comprising a piercing tip; and

a regulator channel positioned at least partially within the piercing member and comprising a first regulator channel opening in fluid communication with the first regulator lumen, wherein the regulator assembly is configured to permit passage of fluid from the second regulator lumen to exit the adaptor and into the ambient environment.