Connector assembly and methods of use

Inventors

Gutzler, Dominik • Young, Wei-Tai

Assignees

Cytosorbents Inc • Cytosorbents Corp

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Publication Number

US-11969535-B2

Patent

Publication Date

2024-04-30

Expiration Date


Abstract

Connector assemblies and methods of replacing components in an extra-corporeal circuit (ECC) system are disclosed. A connector assembly for use in an ECC system includes a tubular body having an inner surface defining a lumen extending through the tubular body with the lumen extending along a longitudinal axis, a first connection interface in fluid communication with the lumen, a second connection interface in fluid communication with the lumen, and a plurality of closure mechanisms, each closure mechanism being configured to occlude the lumen.

Core Innovation

A connector assembly and an ECMO-related method are described for modifying a component during operation of an extracorporeal membrane oxygenation (ECMO) system. The ECMO system includes an active bypass extending between an inlet and an outlet, and an active pathway extending between the inlet and the outlet and in fluid communication with a lumen of a connector. The connector includes a tubular body whose inner surface defines the lumen extending therethrough, a first connection interface engaged with the component, and closure mechanisms configured to change configurations that either obstruct or do not obstruct the lumen.

During modification, the method opens the active bypass such that fluid flows simultaneously through the active bypass and the active pathway from the inlet to the outlet. Opening the active bypass includes switching the first bypass closure mechanism and the second bypass closure mechanism from a closed configuration to an open configuration so that fluid flows into the active bypass at the inlet and out of the active bypass at the outlet. The method then closes the active pathway while fluid flows through the active bypass, including switching the closure mechanisms between open configurations and closed configurations to obstruct fluid flow through the lumen.

After the active pathway is closed while bypass flow continues, the method disconnects the component from the ECMO system by disengaging the component from the connection interface of the connector. The described approach is implemented as a connector/hot-swapping architecture that maintains alternative flow paths during component modification and disconnection, and the partial disclosure further describes purification integration with a blood purification device and purification component exchange coordinated with flow diversion and restoring flow.

Claims Coverage

The partial content provides one independent claim (clm-00001). It covers a component-modification method in an ECMO system during operation, coordinated switching of lumen-occluding closure mechanisms and bypass closure mechanisms using an ECMO active bypass and an active pathway.

Modifying an ECMO-connected component during operation using an active bypass and an active pathway

A method for modifying a component fluidly connected to a connector having a tubular body defining a lumen, in an ECMO system with an active bypass between an inlet and an outlet and an active pathway between the inlet and the outlet in fluid communication with the lumen, the connector having first and second closure mechanisms and a connection interface engaged with the component.

Simultaneously opening bypass flow while lumen flow is allowed through the active pathway

Opening the active bypass such that fluid flows simultaneously through the active bypass and the active pathway from the inlet to the outlet by switching the first bypass closure mechanism from the closed configuration to the open configuration to admit fluid into the active bypass at the inlet, and switching the second bypass closure mechanism from the closed configuration to the open configuration to discharge fluid from the active bypass at the outlet.

Closing the active pathway while maintaining bypass flow by lumen-occluding closure mechanisms

Closing the active pathway while fluid flows through the active bypass from the inlet to the outlet by switching the first closure mechanism from the open configuration to the closed configuration to obstruct fluid flow through the lumen, and switching the second closure mechanism from the open configuration to the closed configuration to obstruct fluid flow through the lumen.

Hot-swapping disconnection after flow diversion using connector disengagement and specific closure actuation

Disconnecting the component from the ECMO system by disengaging the component from the connection interface of the connector after the active pathway is closed while bypass flow continues, wherein switching the first closure mechanism comprises switching a pinch clamp from an open configuration to a closed configuration and switching the second closure mechanism comprises turning a turn valve from an open configuration to a closed configuration.

Across the independent claim, the inventive coverage centers on performing component modification during ECMO operation by coordinating an active bypass that is opened for simultaneous bypass and active pathway flow, closure of the active pathway using lumen-occluding closure mechanisms while bypass flow continues, and subsequent disconnection of the component via disengagement from the connector connection interface, including the specific closure actuation examples of a pinch clamp and a turn valve.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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