# US 12,377,022 B2 · Pressure-regulating vial adaptors > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,377,022 B2 - Document ID: US12377022B2 - Status: Granted - Kind: B2 - Application number: 17/228,990 - Filed: 2021-04-13 - Published: 2021-07-29 - Granted: 2025-08-05 - Earliest claimed: 2014-06-20 - Assignees: ICU Medical, Inc. - Applicants: Icu Medical, Inc. - Inventors: Thomas F. Fangrow - Web page: https://patentgrep.com/patent/US12377022B2 ## CPC - A61J 1/2086: {for fluid filtration} - A61J 1/1406: {Septums, pierceable membranes} - A61J 1/1456: {using liquid filters} - A61J 1/201: {having one piercing end} - A61J 1/2037: {having valve means} - A61J 1/2055: {having gripping means} - A61J 1/2058: {having multiple connecting ports} - A61J 1/2075: {for external venting} - A61J 1/2082: {for gas filtration} - A61J 1/2096: {Combination of a vial and a syringe for transferring or mixing their contents} - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE ## 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 ### Claim 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. ### Claim 2 (depends on 1) The adaptor of claim 1, wherein the regulator valve comprises a circular shape. ### Claim 3 (depends on 1) 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. ### Claim 4 (depends on 3) The adaptor of claim 3, wherein the convex side is located opposite the concave side of the regulator valve. ### Claim 5 (depends on 1) The adaptor of claim 1, wherein the filter is hydrophobic. ### Claim 6 (depends on 1) The adaptor of claim 1, wherein the filter is antimicrobial. ### Claim 7 (depends on 1) The combination of the adaptor of claim 1 and the sealed vial. ### Claim 8 (depends on 1) The adaptor of claim 1, wherein the regulator valve comprises a valve stem and a flap portion. ### Claim 9 (depends on 1) The adaptor of claim 1 further comprising a valve seat being configured to releasably couple with the regulator valve. ### Claim 10 (depends on 9) 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. ### Claim 11 (depends on 10) The adaptor of claim 10, wherein the valve anchor comprises one or more protrusions. ### Claim 12 (depends on 1) 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. ### Claim 13 (depends on 1) The adaptor of claim 1, wherein the plug portion is retained within the regulator lumen by a friction fit. ### Claim 14 (depends on 1) The adaptor of claim 1, wherein the filter is positioned between the regulator valve and the regulator inlet. ### Claim 15 (depends on 1) The adaptor of claim 1, wherein the regulator inlet is configured to be at least partially blocked. ### Claim 16 (depends on 1) The adaptor of claim 1, further comprising a flow inhibitor configured to prevent passage of fluids into the regulator inlet. ### Claim 17 (depends on 1) The adaptor of claim 1, wherein the mating portion is configured to mate with the regulator cap. ### Claim 18 (depends on 1) The adaptor of claim 1, wherein the mating portion comprises an annular protrusion. ### Claim 19 (depends on 1) 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. ### Claim 20 (depends on 1) The adaptor of claim 1, wherein the plug portion is configured to mate with the regulator lumen.