IP Library Granted Patent US 12,280,013
Granted Patent B2
US 12,280,013 · App. 18/312,347 · Granted Apr 22, 2025

Pressure-regulating vial adaptors

Inventor: Thomas F. Fangrow (Mission Viejo, CA)
Assignee: ICU Medical, Inc.
A61J1/2096A61J1/00A61J1/201A61J1/2037A61J1/2075A61J1/2082
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Quick Facts
Patent No.
US 12,280,013
App. No.
18/312,347
Granted
Apr 22, 2025
Kind
B2
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. The regulator assembly can include a valve configured to transition between a closed configuration and an opened configuration.

Claims (27)

1. A method of manufacturing a vial adaptor configured to couple with a vial, the method comprising:

forming a vial adaptor housing comprising:

a connector interface;

an access channel being in fluid communication with the connector interface; and

a regulator channel being configured to permit gas to flow into and out of the vial in order to regulate pressure within the vial during withdrawal of fluid from the vial; and

positioning a valve within the regulator channel, the valve comprising a concave side and a convex side when in a closed position, the valve being configured to permit passage of fluid through the valve in a first direction from the concave side towards the convex side, the valve being configured to inhibit passage of fluid through the valve in a second direction from the convex side towards the concave side.

2. The method of claim 1 , wherein the valve comprises:

a first cracking pressure being configured to transition the valve from the closed position towards an open position and to permit fluid flow through the valve in the first direction, and

a second cracking pressure being configured to transition the valve from the closed position towards the open position and to permit fluid flow through the valve in the second direction,

wherein the first cracking pressure is less than the second cracking pressure.

3. The method of claim 2 , wherein the valve is configured to permit fluid flow through the valve in the second direction when the vial adaptor is coupled to the vial and when sufficient fluid is introduced into the vial through the access channel such that a pressure within the vial is greater than the second cracking pressure.

4. The method of claim 2 , wherein the valve is configured to permit fluid flow through the valve in the first direction when the vial adaptor is coupled to the vial and when sufficient fluid is withdrawn from the vial though the access channel such that a pressure within the vial is less than the first cracking pressure.

5. The method of claim 2 , wherein the second cracking pressure is substantially higher than the first cracking pressure.

6. The method of claim 1 , wherein the valve comprises a domed valve.

7. The method of claim 1 , wherein the convex side of the valve is in fluid communication with the vial when the valve is in the closed position and when the vial adaptor is coupled to the vial.

8. The method of claim 1 , wherein the valve further comprises one or more slits configured to permit the valve to permit passage of fluid through the valve.

9. The method of claim 8 , wherein the one or more slits bias the valve towards the closed position.

10. The method of claim 1 , wherein the valve comprises an annular flange being configured to engage a portion of the regulator channel.

11. The method of claim 1 , wherein the valve is fixed within the regulator channel.

12. The method of claim 11 , wherein the regulator channel comprises one or more fitted channels configured to engage the valve.

13. The method of claim 1 , wherein the convex side of the valve is located opposite the concave side of the valve.

14. The method of claim 1 , further comprising disposing a filter in fluid communication with the regulator channel, the filter being configured to filter fluid passing into the regulator channel and being configured to inhibit passage of at least one of liquid or microbes past the filter.

15. The method of claim 14 , wherein the filter is in fluid communication with the concave side of the valve when the valve is in the closed position.

16. The method of claim 14 , wherein the valve is configured to inhibit liquid within the vial from passing through the valve in the second direction and from engaging the filter when the vial adaptor is coupled with the vial.

17. The method of claim 14 , wherein the filter is hydrophobic.

18. The method of claim 14 , wherein the filter is anti-microbial.

19. The method of claim 1 , wherein forming the vial adaptor housing comprises forming a piercing member comprising a proximal end and a distal end, the distal end comprising a piercing tip, wherein the regulator channel is positioned at least partially within the piercing member.

Assignments (2)
SECURITY INTEREST Recorded Oct 31, 2025
From: ICU MEDICAL, INC.; EXCELSIOR MEDICAL CORPORATION; TANGENT MEDICAL TECHNOLOGIES, INC.
To: WELLS FARGO BANK, NATIONAL ASSOCIATION, AS COLLATERAL AGENT
Reel/Frame 073428/0588 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 16, 2024
From: FANGROW, THOMAS F.
To: ICU MEDICAL, INC.
Reel/Frame 068597/0119 →
Continuity (12)
Continuation 17527818 · Nov 16, 2021
Continuation 17149165 · Jan 14, 2021
Continuation 16418008 · May 21, 2019
Continuation 15476566 · Mar 31, 2017
Continuation 14488856 · Sep 17, 2014
Continuation PCTUS2013033183 · Mar 20, 2013
Provisional Application 61785874 · Mar 14, 2013
Provisional Application 61755800 · Jan 23, 2013
Provisional Application 61705988 · Sep 26, 2012
Provisional Application 61684095 · Aug 16, 2012
Provisional Application 61614250 · Mar 22, 2012
Related Publication 20230355476A1 · Nov 9, 2023
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