Connector assemblies, fluid systems, and methods for making...

Details Connector assemblies, fluid systems, and methods for making... Connector assemblies, fluid systems, and methods for making...

2000-06-26

2003-12-02

Chambers, A. Michael (Department: 3753)

Valves and valve actuation

With correlated flow path

Valve operated by joining flow path sections

C604S256000, C604S905000

Reexamination Certificate

active

06655655

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to connector assemblies, fluid systems or devices including a connector assembly, and methods for making a connection. More particularly, the invention relates to connector assemblies and fluid systems or devices, which maintain the sterility of a fluid which passes through them, and methods for making a sterile connection.
BACKGROUND OF THE INVENTION
Connector assemblies have been developed to handle fluids e.g., biological fluids, while preserving their condition. More particularly, connectors have been developed to preserve the condition of a fluid, or maintain a fluid free of contaminants. Freedom from contaminants refers to a relative amount of contaminants and is variously defined according to a specific industry, fluid and/or intended use. For example, a biological fluid is considered free of contaminants if it is substantially free of viable microorganisms and is typically referred to as “sterile”. Connector assemblies for use with biological fluids, for example, have been fashioned to preserve sterility of the fluid.
Attempts have been made to develop connector assemblies which isolate a fluid from the ambient environment of the connector, and from contaminants entrained in the ambient environment. Such connectors typically define a fluid conduit, the interior of which is isolated from the ambient environment. Some conventional connector assemblies include mating male and female connectors having opposing surfaces and a removable protective cover on each opposing surface to be contacted. These covers must be removed prior to actually coupling the connectors.
A problem associated with these conventional connector assemblies in which protective covers must be removed prior to coupling is that removing the covers may not sufficiently protect the fluid flowing through these assemblies. To unfasten and remove a cover, a technician must manually manipulate the removable cover in intimate proximity to the protected region under the cover, risking incidental contact and the transmission of contaminants to the protected region.
In addition, once the protective covers are removed from the protected surfaces, the protected regions are exposed to the contaminant-laden ambient environment. For example, as the connectors are brought together, dust, micro-organisms, and other airborne contaminants may contact the protected regions, even if the connectors are quickly mated. Thus, while these conventional connector assemblies have been developed to form a sterile connection. none adequately protect the fluid flowing through the connector assembly.
Another type of conventional connector assembly comprises mating male and female fittings, each fitting having a protective cover attached to a connecting end of the fitting, and a piercing member inside the male fitting to pierce the protective covers and join the interiors of the mating fittings. One problem with these fittings is that the piercing member may prematurely pierce the cover before the fittings are coupled together. As a result, contaminants may enter the connector and it must either be resterilized or discarded.
Another problem which may occur with conventional connector assemblies including piercing members is that the piercing member may sever a portion of one or both of the covers between the connecting ends of the male and female fittings when the fittings are coupled together. The severed portion of the membrane may enter a fluid flow path defined by the interior region of the fittings and contaminate the system or interfere with the flow of fluid through the connector.
Another problem that exists with conventional connector assemblies is obtaining a good seal between the male and female fittings. When the protective covers covering the connecting ends are removed and the connecting ends of male and female fittings are joined, there may be gaps between the joined connecting ends due to unmatched surfaces. The gaps may allow contaminants to enter and compromise the sterility of the inner region of the fittings. Thus, there exists a need for a sterile connector assembly which provides a good seal between opposing connecting ends of the male and female fittings.
Another problem associated with conventional connectors having protective covers is that, prior to assembly of the connectors, the protective covers are exposed. Consequently, when the connectors are handled, the protective covers may be easily damaged or punctured, or accidentally or inadvertently removed. As a result, the contaminants may enter the connectors, and the connectors must be discarded. In some cases, the damages to the protective covers may not be easily discovered, and contaminated connectors may be unknowingly used and the fluid flowing through the connector assembly may be contaminated.
SUMMARY OF THE INVENTION
Various aspects of the present invention overcome many of the problems associated with the conventional connector assemblies, including many of the problems previously outlined.
In accordance with one aspect of the invention, a connector assembly comprises a first fitting, a second fitting, a socket, a resilient sealing member, and a stem. The first fitting includes an aperture and the second fitting, which is capable of being coupled to the first fitting, also includes an aperture. The socket, which includes a side wall, is cooperatively arranged with the first fitting or the second fitting. The resilient sealing member is disposed in the socket. The resilient sealing member includes a first portion disposed in the socket and contacting the side wall of the socket and a second portion disposed in the socket and spaced from the side wall of the socket. The stem, which includes a head, is disposed in the first fitting. The stem is axially movable through the socket and the resilient sealing member into the aperture of the second fitting.
In accordance with another aspect of the invention, a connector assembly comprises a first fitting, a second fitting, a socket, a resilient sealing member, and a stem. The first fitting includes an aperture and the second fitting, which is capable of being coupled to the first fitting, also includes an aperture. The socket is cooperatively arranged with the first fitting or the second fitting. The resilient sealing member, which is disposed in the socket, includes a first portion, a second portion, and a third portion. The second portion is disposed between the first portion and the third portion and has a thinner wall than the first portion and the third portion. The stem, which includes a head, is disposed in the first fitting. The stem is axially movable through the socket and the resilient sealing member into the aperture of the second fitting.
In some embodiments of the invention, a connector assembly also comprises a sealing layer. The socket includes an open end, and the sealing layer is removably joined to the open end of the socket and is removable from the socket.
In some embodiments of the invention, a connector assembly also comprises a sealing layer. The socket includes a continuous cylindrical wall, and the sealing layer covers the resilient sealing member. The stem includes a distal end sealed to the first fitting and is axially movable through the first fitting, the socket, and the resilient sealing member into the aperture of the second fitting.
In some embodiments of the invention, a connector assembly also comprises a removable sealing layer. The removable sealing layer contacts the resilient sealing member.
In some embodiments of the invention, a connector assembly also comprises a deformable locking device. The stem is axially movable through the aperture of the first fitting into the aperture of the second fitting. The deformable locking device includes a bendable member arranged between the first fitting and the stem to prevent the head from moving through the aperture of the first fitting. In some embodiments of the invention, a connector assembly also comprises a first cap, a second cap, and a sealing layer. The first fitting has a

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