IP Library › Granted Patent US 12,350,237
Granted Patent B2
US 12,350,237 · App. 18/308,500 · Granted Jul 8, 2025

Pressure-regulating vial adaptors

Inventor: Thomas F. Fangrow (Mission Viejo, CA)
Assignee: ICU Medical, Inc.
A61J1/2096A61J1/201A61J1/2048A61J1/2075A61J1/2082A61J1/2086B65B3/003A61J1/10Y10T29/49826
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Quick Facts
Patent No.
US 12,350,237
App. No.
18/308,500
Granted
Jul 8, 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. 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 (42)

1. A pressure-regulating vial adapter comprising:

a housing having an interface, a cap connector, and a lumen, the interface configured to connect to a syringe, the cap connector configured to connect to a vial having a septum;

a piercing member configured to be inserted through the septum of the vial;

an access channel configured to convey liquid between the syringe and the vial;

a regulator enclosure comprising a flexible first side and a flexible second side, the regulator enclosure positioned outside the vial;

a regulator channel configured to convey regulating fluid, the regulator channel extending between the regulator enclosure and the vial;

a coupling located intermediate the regulator enclosure and the lumen, wherein the regulator channel passes through the coupling;

a first valve configured to open to allow ambient air to enter the regulator channel; and

a second valve configured to control regulating fluid flow in the regulator channel, the second valve comprising a two-way valve;

wherein the flexible first and second sides are configured to receive regulating fluid therebetween and wherein the flexible first and second sides are each configured to unfold in response to an introduction of liquid into the vial via the access channel.

2. The pressure-regulating vial adapter of claim 1 , wherein the first valve comprises a check valve.

3. The pressure-regulating vial adapter of claim 1 , wherein the first valve comprises a diaphragm check valve.

4. The pressure-regulating vial adapter of claim 1 , wherein the first valve is on the coupling.

5. The pressure-regulating vial adapter of claim 1 , wherein the second valve comprises an orientation-sensitive valve.

6. The pressure-regulating vial adapter of claim 1 , wherein the second valve comprises a dome valve.

7. The pressure-regulating vial adapter of claim 1 , wherein the regulator enclosure comprises a bag.

8. The pressure-regulating vial adapter of claim 1 , wherein the regulator enclosure is configured to expand laterally outward from the housing.

9. The pressure-regulating vial adapter of claim 1 , further comprising a rigid housing, wherein the regulator enclosure is configured to expand out of the rigid housing.

10. The pressure-regulating vial adapter of claim 1 , wherein the flexible second side is positioned laterally outward of the flexible first side.

11. The pressure-regulating vial adapter of claim 1 , wherein the flexible first side comprises a first sheet and the flexible second side comprises a second sheet, the first and second sheets bonded together at a periphery of the first and second sheets.

12. The pressure-regulating vial adapter of claim 1 , further comprising a filter configured to filter ambient air that enters the pressure-regulating vial adapter.

13. The pressure-regulating vial adapter of claim 1 , wherein the interface is on a top of the housing, the cap connector is on a bottom of the housing, and the lumen on a lateral side of the housing.

14. The pressure-regulating vial adapter of claim 1 , further comprising a center of mass and a central axis, the center of mass being is sufficiently near the central axis such that the pressure-regulating vial adapter is inhibited from tipping-over when connected to the vial.

15. The pressure-regulating vial adapter of claim 1 , wherein the first valve comprises a diaphragm check valve and the second valve comprises a dome valve.

16. The pressure-regulating vial adapter of claim 1 , wherein the first valve is on the coupling and the second valve is within the regulator channel.

17. The pressure-regulating vial adapter of claim 1 , wherein the first valve comprises a diaphragm check valve on the coupling and the second valve comprises a dome valve within the regulator channel.

18. A pressure-regulating vial adapter comprising:

a housing having an interface, a cap connector, and a lumen, the interface configured to connect to a syringe, the cap connector configured to connect to a vial having a septum;

a piercing member configured to be inserted through the septum of the vial;

an access channel configured to convey liquid between the syringe and the vial;

a regulator comprising a mouth, a flexible first side, and a flexible second side, the regulator positioned outside the vial;

a regulator channel configured to convey regulating fluid between the regulator and the vial; and

a rigid enclosure comprising an inner surface and an outer surface, the regulator positioned at least partly within the rigid enclosure, the mouth of the regulator connected to the inner surface of the rigid enclosure;

wherein the flexible first and second sides are configured to unfold in response to an introduction of liquid into the vial such that regulating fluid is received between the flexible first and second sides; and

wherein the flexible first and second sides are further configured to crumple in response to withdrawal of liquid from the vial.

19. The pressure-regulating vial adapter of claim 18 , wherein the regulator is further configured to unfold laterally outward with respect to a longitudinal axis of the pressure-regulating vial adapter.

20. The pressure-regulating vial adapter of claim 18 , further comprising a coupling connected with the lumen, the regulator channel passing through at least the coupling and the lumen.

21. The pressure-regulating vial adapter of claim 20 , wherein the lumen and the coupling extend laterally outward with respect to a longitudinal axis of the pressure-regulating vial adapter.

22. The pressure-regulating vial adapter of claim 20 , wherein the coupling is received partially inside the lumen.

23. The pressure-regulating vial adapter of claim 18 , wherein, with the pressure-regulating vial adapter connected with the vial right-side-up, the interface is oriented upward, the cap connector is oriented downward, and the lumen is oriented sideways.

24. The pressure-regulating vial adapter of claim 18 , wherein the flexible first side comprises a first sheet and the flexible second side comprises a second sheet, the first and second sheets connected at a periphery of the first and second sheets.

25. The pressure-regulating vial adapter of claim 18 , wherein the mouth of the regulator is positioned within a chamber bounded by the inner surface of the rigid enclosure.

Assignments (1)
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 →
Continuity (9)
Continuation 17445705 · Aug 23, 2021
Continuation 16872754 · May 12, 2020
Continuation 15932248 · Feb 16, 2018
Continuation 14789806 · Jul 1, 2015
Continuation 14179475 · Feb 12, 2014
Continuation PCTUS2012051226 · Aug 16, 2012
Provisional Application 61614250 · Mar 22, 2012
Provisional Application 61525126 · Aug 18, 2011
Related Publication 20240091104A1 · Mar 21, 2024
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