Granted Patent B2

US 12,544,309 · App. 18/066,506 · Granted Feb 10, 2026

Inventor: Thomas F. Fangrow (Mission Viejo, CA)

Assignee: ICU MEDICAL, INC.

A61J1/2072A61J1/1406A61J1/201A61J1/2037A61J1/2048A61J1/2082A61J1/2096A61M5/32A61J1/1456

Abstract

Claims (23)

1 . A method of manufacturing a pressure-regulating vial adaptor, the method comprising:

selecting a body portion comprising a regulator channel extending between a piercing member and a proximal regulator aperture; and

coupling a regulator assembly with the regulator channel, the regulator assembly comprising:

a regulator base comprising an annular wall;

a regulator nest being configured to couple with the regulator base;

a flexible enclosure being at least partially positioned within the regulator nest, the flexible enclosure being configured to transition between a stored configuration and an expanded configuration; and

a cover being coupled to the regulator base such that the cover at least partially extends along the flexible enclosure, the annular wall, and the regulator nest, the cover comprising an aperture, the cover being further configured to permit the flexible enclosure to at least partially extend through the aperture as the flexible enclosure transitions from the stored configuration towards the expanded configuration, the cover comprising an annular side portion extending along the annular wall and a rear flange extending towards a longitudinal axis of the regulator assembly, such that the cover wraps around at least a portion of the regulator base.

2 . The method of claim 1 , wherein the annular wall extends around an outer perimeter of the regulator base.

3 . The method of claim 1 , wherein the annular wall extends beyond the regulator nest such that the cover engages the annular wall.

4 . The method of claim 1 , wherein the annular wall comprises an outer surface, and wherein the outer surface is seamless.

5 . The method of claim 1 , further comprising wrapping the cover at least partially around the flexible enclosure, the annular wall, and the regulator nest.

6 . The method of claim 1 , further comprising adhering the cover to at least one of the annular wall or the regulator nest.

7 . The method of claim 1 , further comprising covering an outer surface of the regulator base with the annular side portion by fitting the annular side portion around the annular wall of the regulator base.

8 . The method of claim 1 , wherein the cover is configured to stretch as the flexible enclosure transitions from the stored configuration towards the expanded configuration.

9 . The method of claim 8 , wherein the cover is further configured to remain coupled to the regulator base when the flexible enclosure transitions from the stored configuration towards the expanded configuration.

10 . The method of claim 1 , wherein the cover is fluid impermeable.

11 . The method of claim 1 , further comprising forming the cover from at least one of coated paper, silicone, foil, polyolefin, polyvinyl chloride, polyethylene, polypropylene, a multilayer polymer composition, or a copolymer.

12 . The method of claim 1 , wherein the cover is transparent.

13 . The method of claim 1 , wherein the cover is opaque.

14 . The method of claim 1 , wherein the cover is toroidal.

15 . The method of claim 1 , wherein the cover comprises a compact profile.

16 . The method of claim 1 , wherein the aperture comprises an aperture width less than a regulator width of the regulator assembly.

17 . The method of claim 16 , wherein the aperture width is less than or equal to two-thirds of the regulator width.

Assignments (2)

Continuity (4)

References Cited (400)