IP Library Granted Patent US 12,377,022
Granted Patent B2
US 12,377,022 · App. 17/228,990 · Granted Aug 5, 2025

Pressure-regulating vial adaptors

Inventor: Thomas F. Fangrow (Mission Viejo, CA)
Assignee: ICU Medical, Inc.
A61J1/2086A61J1/1406A61J1/1456A61J1/201A61J1/2037A61J1/2055A61J1/2058A61J1/2075A61J1/2082A61J1/2096
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Quick Facts
Patent No.
US 12,377,022
App. No.
17/228,990
Granted
Aug 5, 2025
Kind
B2
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 (33)

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

a regulator lumen;

a plug portion sized and shaped to be inserted into the regulator lumen;

an anchor sized and shaped to limit an extent to which the plug portion is inserted into the regulator lumen;

a mating portion configured to engage at least a portion of the regulator assembly and connect the plug portion to at least a part of the regulator assembly;

a regulator cap positioned at the regulator inlet, the regulator cap having an aperture;

a filter capable of fluid communication with the regulator lumen and configured to filter fluid passing into the regulator lumen, the filter being configured to inhibit passage of at least one of liquid or microbials past the filter; and

a regulator valve positioned within the plug portion, the regulator valve configured to permit passage of fluid through the regulator valve from the ambient environment into the regulator lumen, the regulator valve further configured to resist passage of fluid through the regulator valve from the regulator lumen towards the ambient environment such that the regulator valve is configured to inhibit liquid within the sealed vial from passing through the regulator valve, the regulator valve having a cracking pressure greater than or equal to 0.1 psi and less than or equal to 5 psi;

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 regulator channel opening in fluid communication with the regulator lumen.

2. The adaptor of claim 1 , wherein the regulator valve comprises a circular shape.

3. The adaptor of claim 1 , wherein the regulator valve comprises a convex side and a concave side when the regulator valve is in a resting orientation.

4. The adaptor of claim 3 , wherein the convex side is located opposite the concave side of the regulator valve.

5. The adaptor of claim 1 , wherein the filter is hydrophobic.

6. The adaptor of claim 1 , wherein the filter is antimicrobial.

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

8. The adaptor of claim 1 , wherein the regulator valve comprises a valve stem and a flap portion.

9. The adaptor of claim 1 further comprising a valve seat being configured to releasably couple with the regulator valve.

10. The adaptor of claim 9 , wherein the regulator valve comprises a valve anchor configured to inhibit decoupling of the regulator valve and the valve seat.

11. The adaptor of claim 10 , wherein the valve anchor comprises one or more protrusions.

12. The adaptor of claim 1 , wherein the anchor comprises a cross-sectional width that is larger than a cross-sectional width of the plug portion.

13. The adaptor of claim 1 , wherein the plug portion is retained within the regulator lumen by a friction fit.

14. The adaptor of claim 1 , wherein the filter is positioned between the regulator valve and the regulator inlet.

15. The adaptor of claim 1 , wherein the regulator inlet is configured to be at least partially blocked.

16. The adaptor of claim 1 , further comprising a flow inhibitor configured to prevent passage of fluids into the regulator inlet.

17. The adaptor of claim 1 , wherein the mating portion is configured to mate with the regulator cap.

18. The adaptor of claim 1 , wherein the mating portion comprises an annular protrusion.

19. The adaptor of claim 1 , further comprising a valve seat configured to support the regulator valve and connect the regulator valve to the plug portion.

20. The adaptor of claim 1 , wherein the plug portion is configured to mate with the regulator lumen.

Assignments (2)
SECURITY AGREEMENT Recorded Mar 31, 2022
From: ICU MEDICAL, INC.
To: WELLS FARGO BANK, NATIONAL ASSOCIATION
Reel/Frame 059618/0412 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 13, 2021
From: FANGROW, THOMAS F.
To: ICU MEDICAL, INC.
Reel/Frame 055903/0947 →