Method and apparatus for sealed, sterile connection

• US 4,004,586 A
• Filed: 03/12/1975
• Issued: 01/25/1977
• Est. Priority Date: 03/12/1975
• Status: Expired due to Term

• Current Assignee: Baxter Travenol Laboratories Incorporated (Baxter International Inc.)
• Original Assignee: Baxter Travenol Laboratories Incorporated (Baxter International Inc.)
• Inventors: Hektner, Thomas R., Olson, Steven L., Christensen, John G.
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US05/557,853
• Time in Patent Office: 685 Days
• Field of Search: 128/214 R, 128/214 D, 128/214 C, 128/214.2, 222/83, 285/3, 285/260
• US Class Current: 604/413
• 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

First and second sealed, sterile containers, having respectively communicating first and second fluid transfer tubes, the tubes having diaphragms occluding the bores thereof, may be connected together in sterile manner for the sterile transfer of the contents of one container to the other. To accomplish this, one point of a double-pointed, hollow spike is inserted into each of the bores of the fluid transfer tubes, at the free ends thereof, the spike being proportioned to tightly and sealingly fit into each bore of the fluid transfer tubes. Thereafter, the spike and that portion of the tubes extending from the diaphragms to the free ends thereof are sterilized. Then the points of the spike are moved to rupture the diaphragms, to open a flow channel, and the sterile contents are transferred. The fluid transfer tube of the container receiving the desired sterile contents is then resealed, prior to breaking sterility by opening the connection.

Claims

1. The method of transferring sterile contents from a first, sealed, sterile container, having a first, flexible, sealed, fluid transfer tube, to a second, sealed, sterile container having a second, flexible, sealed, fluid transfer tube, said first and second tubes communicating at one end with their respective sealed, sterile containers, said first and second tubes having a free end, and being each sealed with a diaphragm across their bores, said diaphragms being spaced from the free ends of said first and second tubes, said method comprising:

inserting one end of a double-ended, hollow spike into each of the bores of said first and second tubes at the free end thereof, said spike being proportioned to tightly and sealingly fit into each bore of the first and second tubes;

sterilizing said spike and that portion of said first and second tubes extending from each said diaphragm to the free ends of said tubes; and

thereafter

axially collapsing said first and second tubes adjacent the free ends thereof to pass the ends of said spike through said diaphragms to open a flow channel between said first and second containers;

transferring said sterile contents through said fluid transfer tubes from said first to said second container; and

resealing said second fluid transfer tube while sterility is retained in said second tube.

2. The method of claim 1 in which the fluid transfer tubes are mechanically prevented from axial collapse to rupture said diaphragms, until after said sterilizing.

3. The method of claim 1 in which said first fluid transfer tube is resealed while sterility is retained therein.

4. A sealed sterile connection means between a first, sealed, sterile container having a sealed, flexible, sterile fluid transfer tube communicating at one end thereof with said first container and having a free end, and a second, sealed, sterile container having a second, sealed, flexible sterile fluid transfer tube communicating at one end thereof with said second container, and having a free end, said first and second fluid transfer tubes being each sealed with a diaphragm across their respective bores, said diaphragms being spaced from the free ends of said tubes, the improvement comprising:

A double-ended, hollow spike, one end of said spike being inserted into each of the bores of said first and second tubes at the free ends thereof but spaced from said diaphragms to maintain the diaphragms intact, said spike being proportioned to tightly and sealingly fit into each bore of said first and second tubes, said first and second tubes being each sufficiently flexible adjacent their free ends to permit manual axial collapse thereof, to permit said diaphragms to be penetrated by the ends of said spike.

5. A sealed sterile connection means between a first, sealed, sterile container having a sealed, flexible, sterile fluid transfer tube communicating at one end thereof with said first container and having a free end, and a second, sealed, sterile container having a second, flexible, sterile fluid transfer tube communicating at one end thereof with said second container and having a free end, said first and second fluid transfer tubes being each sealed with a diaphragm across their respective bores, said diaphragms being spaced from the free ends of said tubes, the improvement comprising:

a double-ended, hollow spike, one end of said spike being inserted into each of the bores of said first and second tubes at the free ends thereof, but spaced from said diaphragms to maintain the diaphragms intact, said spike being proportioned to tightly and sealingly fit into each bore of said first and second tubes, said first and second tubes being each sufficiently flexible adjacent their free ends to permit manual axial collapse thereof, to permit said diaphragms to be penetrated by the ends of said spike, and

7. The connection means of claim 5 in which the free end of each said flexible, sealed tube comprises a tubular connector member having a first external flange about its free end and a second external flange positioned on said tube near said diaphragms, and said clip members are positioned between said first and second flanges to facilitate the prevention of said axial collapse.

9. The connection means of claim 7 in which said clip member defines a rigid, malleable structure of hollow cylindrical shape, said structure defining an axial, open slot along the entire length thereof to facilitate the installation and removal of said clip member;

a transverse, intermediately located cutaway portion, to define a strip portion connecting the respective ends of said clip member;

a tab portion being located adjacent one end thereof, whereby the end of said clip member which carries the tab portion may be bent about said strip portion away from said connector member to permit the axial collapse thereof.

11. The device of claim 9 in which said first and second containers are plastic blood bags.

12. The device of claim 9 in which said connector member includes said diaphragm, and is made of silicone rubber.

13. The sealed sterile connection means of claim 5 in which the free ends of said first and second fluid transfer tubes are of identical shape.

15. The sealed sterile container of claim 13 including a double-pointed hollow spike, one point of said spike being inserted in the bore of said fluid transfer tube at the free end thereof, but spaced from said diaphragm, said spike being proportioned to tightly and sealingly fit into the bore of said free end, whereby, upon connection of the other point of said spike into the bore of another sealed, flexible, fluid transfer tube, and subsequent sterilization, a sterile path may be provided by axially collapsing said fluid transfer tube so that the spike ruptures the diaphragm.

16. The sterile container of claim 13 which is a blood bag.

17. The sterile container of claim 13 which is a bag for physiological solution and which carries a plurality of flexible, sealed fluid transfer tubes.

18. The sealed, sterile container of claim 13 in which said free tube end comprises a tubular connector member which includes said diaphragm, said connector member being made of silicone rubber.

19. The sealed, sterile container of claim 17 in which a portion of said tubular connector member is of reduced thickness to facilitate the axial collapse, when said clip member is removed.

20. The sealed, sterile container of claim 18 in which said clip member defines a rigid, malleable structure of hollow cylindrical shape, said structure defining an axial, open slot along the entire length thereof to facilitate the installation and removal of said clip member;

a transverse, intermediately located cutaway portion, to define a strip portion connecting the respective ends of said clip member;

a tab portion being located adjacent one end thereof, whereby the end of said clip member which carries the tab portion may be bent about said strip portion away from said connector member, to pemit the axial collapse thereof.

21. The sealed, sterile container of claim 19 in which said connector member defines a partial flange having a longitudinal opening defined therethrough, said partial flange being located intermediate said first and second flanges on the exterior of said connector member, said strip member of the clip member being positioned in said opening.

6. removable clip members surrounding each said fluid transfer tube adjacent each free end, to prevent said axial collapse, and consequent rupturing of the diaphragms of said tubes, by said hollow spike prior to removal of said clip member in which the free end of said sealed, flexible tube is provided with a first external flange adjacent its free end and a second external flange positioned on said tube adjacent said diaphragm, said clip member being positioned in an abutting relationship between said first and second flanges.

8. The connection means of claim 6 in which a portion of each said tube adjacent said clip member is of reduced thickness to facilitate axial collapse when said clip member is removed.

10. The connection means of claim 8 in which said connector member defines a partial flange having a longitudinal opening defined therethrough, said partial flange being located intermediate said first and second flanges on the exterior of said tube, said strip member of the clip member being positioned in said opening.

14. A sealed, sterile container having a sealed, flexible, sterile fluid transfer tube communicating at one end thereof with said container and having a free end;

the improvement comprising;

a diaphragm positioned across the bore of said tube, said diaphragm being spaced from the free end thereof, said tube being sufficiently flexible to permit manual axial collapse thereof adjacent said free end, and a removable clip member surrounding said fluid transfer tube adjacent the free end thereof, to prevent said axial collapse prior to removal of said clip member.