Sterile connection device

• US 4,511,359 A
• Filed: 09/29/1982
• Issued: 04/16/1985
• Est. Priority Date: 09/29/1982
• Status: Expired due to Fees

• Current Assignee: Futura Medical Corporation (Futura Medical Plc)
• Original Assignee: Manresa, Inc.
• Inventors: Vaillancourt, Vincent L.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Lester, Michelle N.
• Application Number:
  US06/426,260
• Time in Patent Office: 930 Days
• Field of Search: 604/283, 604/905, 604/87, 604/88, 604/200, 604/201, 604/244, 604/411, 285/3
• US Class Current: 604/411
• CPC Class Codes: A61M 2039/1033 Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
• CPC Class Codes: A61M 2039/1066 having protection means, e.g. sliding sleeve to protect connector itself, shrouds to protect a needle present in the connector, protective housing, isolating sheath
• CPC Class Codes: A61M 39/14 for connecting tubes having sealed ends needle sets A61M5/162; having valves closing automatically on disconnection of line A61M39/26
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

This invention shows a sterile connection device as made in several embodiments but with a common purpose in which a protector may be pierced, penetrated or opened by pressurized fluid flow by means carried on a influent connector member but with the withdrawal of this means the protector is closed to the passage of unwanted contaminents. The influent connector may be conduit, a syringe or a like member with or without a needle, or a influent connector made as a molding and with or without a needle. The protector, if resilient, may be a secured diaphragm; a duckbill valve, or a slit in a resilient wall of a tubular member removably mountable on an extending tubular end of a effluent connector. The influent connector and the effluent connector are formed of plastic with molding processes providing the desired tolerances. The influent connector has means for conducting fluid to and through a small aperture therein and with this small aperture being in and through a small rigid structure device carried by the influent connector. A protector member of a resilient composition and characterized as having residual bias is adapted to be penetrated at a selected area by this small rigid structure carried by this half. A effluent connector has a fluid pathway and conduit therefrom. This effluent connector is adapted to receive and releasably retain this influent connector device and the protector member and with separation of the halves of the connection device the protector is carried in and remains within the effluent member so as to provide a barrier to unwanted contamination of the discharge conduit. A rigid protector is also shown with a one-way valve construction opened with pressurized fluid.

Claims

1. A sterile connection device adapted for connecting a source of fluid from an influent connector to an effluent connector and providing a resilient protector member carried by the effluent connector, this protector member having an initially imperforiate barrier wall and when the connectors are brought to a closed condition a sharpened hollow needle carried by the influent connector penetrates said resilient barrier wall to establish a fluid flow path and when the connectors are caused to be separated the penetration of the barrier wall by the hollow needle is discontinued with the needle remaining in the influent connector, this withdrawal of the needle allowing the residual bias in the protector to close the penetration site in the barrier wall and provide exclusion of unwanted contaminants into the discharge conduit, said sterile connector device including:

(a) an influent connector providing a female configuration with a cylindrically-formed interior in which at least the outer portion thereof is formed with a precise diameter tubular skirt portion and made as a stepped configuration with a smaller diameter portion extending forwardly of and from the skirt portion and with this differential in diameters forming and providing a stop shoulder, said connector having the opposite end a closing end in which a sharpened hollow needle is carried in and by a post portion of a given extent, said post portion extending into the cylindrically-formed interior and with the sharpened needle extending from said post portion a short distance into said tubular skirt portion with the remaining skirt portion open to the end and providing a smooth circular cavity;

(b) a protector member of resilient material having sufficient residual bias to close an aperture formed in a barrier wall portion of said protector member, said aperture formed by an inserted needle carried in and by the influent connector, said protector member having a forward and a rearward end and of generally circular configuration, the rearward portion being a skirt having an interior diameter of precise size and with this rearward portion integrally connected to said forward portion, the forwardly extending portion of the resilient protector member being formed as a reduced diameter portion of the rearward skirt portion, with this reduced diameter providing a free fit in the smaller diameter stepped bore in the influent connector, and between the forwardly extending portion and the rearwardly extending skirt portion of the resilient protector member is a differential of diameters which provides a stop shoulder adapted to engage the stop shoulder in the influent connector to establish the limit for said closed condition and position;

(c) a substantially rigid effluent connector providing a male configuration with a fluid pathway and conduit formed in a rear-end portion thereof and with said pathway and conduit substantially central of said connector, said connector having a tubular forwardly extending portion and a larger rearwardly extending enlarged tubular portion providing a shoulder at the joining of said external portions, this forwardly tubular portion sized to releaseably retain the outer skirt portion of the protector member and providing therewith a friction fit with the outer surface diameter of tubular forwardly-extending portion of the effluent connector, the rearwardly enlarged portion of the effluent connector sized to provide a mating and sliding fit within the tubular skirt portion of the influent connector, and

(d) a forwardly-extending portion of the protector member sized to be a free sliding fit within the tubular skirt portion of the influent connector and forming in this forwardly-extending portion of the resilient protector member a central recess of a diameter to provide a free sliding fit on the post of the influent connector, said central recess of a depth sufficient to accept much of the post, with said extending portion of the resilient protector member and central recess therein providing means to prevent unwanted exposure to exterior contaminants, including fingers, when the influent connector and needle are removed, this recess terminating with said barrier wall which is of a thickness to be penetrated by the sharpened needle when the influent and effluent connectors are brought to closed condition.

2. A sterile connection device as in claim 1 in which the effluent connector has at least two pins extending outwardly and adapted to enter and be retained in L-shaped cutouts formed in said influent connector to effect selective connection and disconnection by a bayonet construction as provided on the influent and effluent halves.

3. A sterile connection device, as in claim 1, in which the resilient protector member at the barrier wall and opposite the central recess is formed with a rearwardly extending tubular portion whose outer diameter is sized to provide an internal guide and retaining means at and on the interior diameter portion of the forwardly extending portion of the effluent connector.