Adhesively activated sterile connector

• US 4,019,512 A
• Filed: 12/04/1975
• Issued: 04/26/1977
• Est. Priority Date: 12/04/1975
• Status: Expired due to Term

• Current Assignee: Living Trust of Francis J Tenczar Western National Bank of Cicero Successor Trustee Under Trust Agreement No H-1296 Dated JUNE 11 1964
• Original Assignee: Francis J. Tenczar
• Inventors: Tenczar, Francis J.
• Primary Examiner(s): Burr, Edgar S.
• Assistant Examiner(s): Hirsch, Paul J.
• Application Number:
  US05/637,750
• Time in Patent Office: 509 Days
• Field of Search: 128/214 R, 128/214.2, 128/218 P, 128/218 PA, 128/221, 128/349 R, 128/272, 285/3, 285/4, 285/DIG. 16
• US Class Current: 604/411
• 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

A sterile connector assembly for moving blood component preparations through a fluid path established by engaged coupling elements within adjoined connectors. The open end of the connectors are closed by barrier membranes covered by protective members with adhesive film between the protective members and the barrier membranes. A pressure cap is mounted on one of the connectors to apply pressure to the adjoining connectors so that the membranes adhere to each other along a sterile surface which is substituted for the non-sterile protective member that is progressively pulled away. A penetrator member associated with one of the coupling elements penetrates the adjoined and adhered membranes so that an associated coupling element can engage the coupling element in the other connector.

Claims

1. A connector assembly for transferring fluids from one source to another under contaminant precluding conditions, including

a first connector having one end for conduit connection to a fluid source and an opposite open end, a first tubular coupling element positioned within said first connector, said first tubular coupling element being communicable with said conduit connection, a penetrating end associated with said first tubular coupling element,

a second connector having one end for conduit connection to a fluid source and an opposite open end, a second tubular coupling element positioned within said second connector, said second tubular coupling element being communicable with said conduit connection, said second tubular coupling element having an end engageable with said first tubular coupling element,

a penetratable barrier assembly closing the open end of each of the connectors, each barrier assembly including a penetratable barrier and a removable protective member, an adhesive film covering a substantial portion of the area between the barrier and the protective member in at least one of said barrier assemblies, said protective member having a barrier portion covering the penetratable barrier, and a handle portion folded over the barrier portion and extending beyond the connector, said handle portions progressively exposing said adhesive film upon being pulled to progressively adhere the protective barriers to each other, and

means to permit relative movement between the penetrating end and the adjoined barriers so that said penetrating end moves through said area of adhesion, said first coupling element engages said second coupling element to establish a fluid path after the adhered barriers are penetrated, said fluid moving through said engaged coupling elements without contacting the penetrated barriers on the penetrating end.

2. A connector assembly which includes the features of claim 1 wherein blood is transferred from one source to another under sterile conditions, wherein the penetratable barriers are bonded at the open end of each connector so that the interior of the connectors may remain sterile;

and wherein each barrier assembly has an adhesive film between the barrier and the protective member.

3. A sterile connector assembly which includes the features of claim 2 wherein the connectors and coupling elements are cylindrical, and said first connector includes an annular sealing member surrounding the first tubular coupling element, said annular sealing member being sealingly movable relative to the interior surface of the first tubular connector.

4. A sterile connector assembly which includes the features of claim 3 wherein said annular sealing member is freely movable within the first connector and is aligned with the open end of the first connector, the penetratable barrier assembly being mounted only the annular sealing member and movable therewith, and said second connector being of reduced diameter relative to said first connector to allow telescopic engagement of the connectors and engagement of the coupling elements when the adjoined barrier assemblies and annular sealing member are moved past a stationary penetrating end associated with said first coupling element.

5. A sterile connector assembly which includes the features of claim 4, and which further includes an elastomeric annular gasket mounted at the open end of a connector, and said penetratable barrier being bonded, in turn, to said annular elastomeric gasket.

6. A sterile connector assembly which includes the features of claim 5, and which further includes a curved shroud at the open end of said first connector, and a leading edge defining a major portion of said opening and a slot defined by said minor portion, and a trailing edge adjoining the face of said freely movable annular sealing member, an undercut at said trailing edge defining a slit so that said leading and trailing edges are in overlapping relationship, whereby the handles of the protective members extend out of the slit when the connectors are adjoined, and are removable through said slit.

7. A sterile connector assembly which includes the features of claim 6, and which further include key elements on said first stationary coupling element, and key seats in said annular sealing member to receive said key elements when the annular sealing member is rotated to register the key seats and elements, and said key elements supporting the annular sealing member against applied pressure when positioned out of registry with the key seats.

8. A sterile connector assembly which includes the features of claim 7, and which further includes stop means on the back side of the annular sealing member to intercept the key elements on the coupling element in one rotated position so the key element and key seat are out of registry;

and to intercept the keys in another rotated position so that the key element and key seat are in registry.

9. A sterile connector assembly which includes the features of claim 3 wherein said annular sealing member is fixed to the coupling element remote from the penetrating end, wherein the open ends of each connector has a flanged edge to facilitate edge to edge abuttment of the connectors, and wherein said first coupling element and fixed annular sealing member are movable to advance the penetrating end past the adjoined barrier assemblies and into said second connector so that the coupling elements may be engaged.

10. A sterile connector assembly which includes the features of claim 9, and which further includes a key element on said first coupling element located outside said first connector in preconnected condition, and a key seat in an end wall of said first connector, whereby rotation of the first coupling element correctly orients the piercing end relative to the adjoined barriers when the keys are in registration.

11. A sterile connector which includes the features of claim 10, and which further includes a curved shroud extending beyond the flanged end of one of the connectors, a major edge portion of the opening being defined by a leading edge on said shroud, and a minor portion of said opening comprising a slot extending to a trailing edge, an undercut slit at said trailing edge wherein said leading and trailing edges are in overlapping relationship.

12. A sterile connector assembly which includes the features of claim 3 wherein said penetrating end is a tubular member mounted to the first tubular coupling element in advance of the open end therof, whereby said first tubular coupling element is recessed in the penetrating end and directly engages the second coupling element in the other connector without contacting portions of the barrier assembly ruptured by the penetrator end.

13. A sterile connector assembly which includes the features of claim 3 and which further includes a thickened forward wall portion on one of the connectors, a shoulder between said thickened wall portion and the continuous housing wall of said one cylindrical connector, a pressure cap having a continuous side wall and an end wall, a central bore in the end wall, and the continuous wall of said one cylindrical connector passing through said central bore, said shoulder intercepted by said end wall, the continuous side wall of the pressure cap overlapping wall portions of the other cylindrical connector when the two connectors are adjoined at their open ends, and interlock means between the continuous wall of the pressure cap and the overlapped continuous wall portion, said interlock means positioned at said overlapped junction to force the end wall of the pressure cap against the continuous shoulder, thus supplying desired pressure to the adjoined barrier assemblies between the connectors.

14. A sterile connector assembly which includes the features of claim 13 wherein said annular sealing member is freely movable within the first connector and is aligned with the open end of the first connector, the penetratable barrier assembly being mounted only to the annular sealing member and movable therewith, and said second connector being of reduced diameter relative to said first connector to allow telescopic engagement of the connectors and engagement of the coupling elements when the adjoined barrier assemblies and annular sealing member are moved past a stationary penetrating end associated with said coupling element.

15. A sterile connector assembly which includes the features of claim 14 and which further includes an elastomeric annular gasket bonded to the face of the annular sealing member and said penetratable barrier being bonded, in turn, to said annular elastomeric gasket.

16. A sterile connector assembly which includes the features of claim 15 and which further includes a curved shroud at the open end of said first connector, and a leading edge defining a major portion of said opening, and a slot defined by said minor portion, and a trailing edge adjoining the face of said freely movable annular sealing member, an undercut at said trailing edge defining a slit so that said leading and trailing edges are in overlapping relationship, and said interlocking means being on the outside of said shroud and on the inside of said continuous wall of the pressure cap.