Sterilizable, medical connector for blood processing

• US 3,986,508 A
• Filed: 11/06/1974
• Issued: 10/19/1976
• Est. Priority Date: 08/22/1973
• Status: Expired due to Term

• Current Assignee: Koch Membrane Systems, Inc. (KOCH Industries Incorporated)
• Original Assignee: Abcor Incorporated
• Inventors: Barrington, James E.
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US05/521,253
• Time in Patent Office: 713 Days
• Field of Search: 128/214 R, 128/214.2, 128/214 C, 128/214 D, 128/215, 128/272, 285/3, 285/260, 137/68, 141/329, 141/330, 222/80-83
• US Class Current: 604/411
• CPC Class Codes: A61L 2/00 Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for contact lenses A61L12/00; atomisers for disinfecting agents A61M; sterilisation of packages or package contents in association with packaging B65B55/00; treatment of water, waste water, sewage or sludge C02F; disinfecting paper D21H21/36; disinfecting devices for water closets E03D; articles having provision for disinfection, see the relevant subclasses for these articles, e.g. H04R1/12
• CPC Class Codes: A61L 2/04 Heat A61L2/08 takes precedence
• CPC Class Codes: A61M 2039/1033 Swivel nut connectors, e.g. threaded connectors, bayonet-connectors
• CPC Class Codes: A61M 2039/1072 with a septum present in the connector
• 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 two-stage, sterilizable connector for use in processing blood, which connector assures sterility when entering a blood bag to add agents required in processing blood, the connector designed to comprise a male and female body element which, in a first extended position, are partially joined, which connector is sterilizable, and which, after sterilization, the male and female body elements are joined in a secured, engaged position to effect the puncturing of the male and female septa to provide a fluid passageway therethrough.

Claims

1. A sterilizable connector for use in processing blood or other fluids, which connector comprises in combination:

a. a male body element;

b. a female body element;

c. the male and female body elements adapted to be couplingly engaged in a first extended position, and, thereafter, in a matingly engaged position which permits the passage of fluid therethrough;

d. means to secure the male and female body elements together when the elements are placed in the matingly engaged position;

e. the male and female body elements each characterized by a coaxial passageway therethrough, the passageway having a one end and another end, one end of each element and passageway adapted to be connected to a connector or fluid source;

f. a male septum at the other end of the male body element, the male septum resilient and adapted to be punctured by a needle, and the male septum closing in a fluid-tight manner the end of the male passageway at the other end, and slidably engaged in a fluid-tight manner with the interior surface of the female element;

g. a female septum positioned within the female passageway a sufficient distance to permit the female and male body elements to be placed in a joined extended position, the female septum resilient and adapted to be punctured by a needle, and slidably engaged in a fluid-tight manner with the female passageway, the face surfaces of the septums being free of adhesive material;

h. means to permit the escape of gas entrapped between the male and female septa when the male and female body elements are placed in a matingly extended position; and

i. a septum-puncturing hollow needle element within the female body element passageway, the interior of the needle providing fluid-flow communication with the one end of the female body element passageway, whereby after sterilization of the connector and on movement by the user of the male or female body elements toward each other, the needle element punctures the male and female septa to provide a sterile fluid passageway through the connector, and the female septum is moved with the passageway so that the septa in the engaged position are in mating engagement.

2. The connector of claim 1 wherein the means to secure the male and female body elements together comprises a longitudinal bayonet-type channel extending along the exterior surface of the male body element, the female body element including an upwardly extending bayonet clasp from its external surface, the clasp adapted to engage the bayonet-type channel, and thereby to permit the male and female body elements to be placed in a matingly engaged secured position.

3. The connector of claim 2 wherein the means to permit the escape of gas in a gap between the septa includes a longitudinal channel extending along the exterior surface of the male or female body elements and into the gap between the septa.

4. The connector of claim 1 wherein the male septum comprises a cap-like element which is secured over the tubular other end of the male body element.

5. The connector of claim 4 wherein the male septum comprises a cap-like element composed of a sterilizable ploymer.

6. The connector of claim 1 wherein the female septum comprises a plug-like septum inserted into the female passageway a predetermined distance and which is composed of a sterilizable polymer.

7. The connector of claim 6 wherein the female septum comprises a C-type form, with the puncturing end of the needle element positioned within the open side of the C-type form, but spaced slightly apart from the septum wall when the male and female body elements are in an extended position.

8. The connector of claim 1 wherein the one and opposite ends of the male and female body elements are tapered down and adapted to be inserted within a plastic tubing.

9. The connector of claim 1 wherin the male and female body elements are composed of a conjectured, molded, medically accepted heat-resistant plastic material, and the male and female septa are composed of a silicone rubber-type material.

10. The connector of claim 1 wherein the main body portions of the male and female elements are characterized by a knurled hand-grasping exterior surface.

11. A blood bag system which comprises a processing bag and one or more reservoirs for the transfer of blood or an agglomerating solution to the blood bag, which system includes one or more connectors of claim 1 to provide for a sterile connector between such reservoirs, witih tubing between the reservoirs and the blood bag.

15. The connector of claim 2 wherein the male septum is a polymeric capped element fitting over the other end of the male element, and includes a longitudinal channel on its exterior surface aligned with the exterior longitudinal channel of the male element, whereby gas entrapped in the gap between the septa, when the elements are moved from an extended to an engaged position, escapes through such channel.

16. The connector of claim 1 wherein the needle element extends from and coaxially with the passageway of the female element, the puncturing end of the needle element spaced apart from the female septum in the extended position, and extending into the coaxial passageway of the male element in the engaged position.

17. The connector of claim 1 wherein the connector is formed of a heat-sterilizable polymeric material, and the male and female septa are formed of the same puncturable heat-sterilizable material.

12. A two-stage sterilizable connector for use in processing blood, which connector comprises in combination:

a. an elongated tubular male body element formed of a medically acceptable sterilizable polymer;

b. an elongated tubular female body element formed of a medically acceptable sterilizable polymer;

c. the male and female body elements adapted to be coupling engaged in a first extended position and in a second matingly engaged position;

d. means to secure the male and female body elements together when the elements are in the second matingly engaged position;

e. the male and female body elements each characterized by an elongated coaxial passageway therethrough, the elements having a one end and another end, one end of each element and passageway adapted to be connected to tubing or a fluid source;

f. a polymeric male cap-like septum at the other end of the male body element, the male cap-like septum adapted to be punctured by a needle, the male cap closing in a fluid-tight manner the other end of the male passageway, and slidably engaged in a fluid-tight manner with the interior surface of the female element;

g. a plug-like polymeric female septum positioned within the female passageway a sufficient distance to permit the male and female body elements to be placed in the first extended position, the female septum adapted to be punctured by a needle, and slidably engaged in a fluid-tight manner within the female passageway, whereby, in the first extended position, there is a gap between the septa, the face surfaces of the septums being free of adhesive material;

h. a vent means to permit the escape of air entrapped in the gap between the male and female septa when the male and female body elements are moved from a first extended position into the second matingly engaged position; and

i. a septum-puncturing thin hollow needle longitudinally positioned within the female body element passageway, the interior of the needle providing fluid-flow communication with one end of the female body element passageway, the other puncturing end of the needle positioned and spaced slightly apart from the wall of the female plug-like septum when the male and female body elements are in their first extended position, whereby after sterilization of the connector, when in the first extended position, and on movement by the user of the male and female body elements toward each other, the needle element punctures the male and female septa, and the female septum is pushed backwardly to place the male and female septa in a close fitting relationship, thereby providing a sterile fluid passageway through the male and female elements of the connector.

13. The connector of claim 12 wherein the male and female septa are composed of a silicone rubber material.

14. The connector of claim 12 wherein the vent means and the means to secure the male and female body elements together comprise a longitudinal bayonet J-type channel extending along the exterior surface of the male body element, the female body element including an upwardly bayonet clasp from its external surface, the clasp adapted to be engaged in the bayonet-type channel, and thereby to permit the male and female body elements to be secured in the second matingly engaged secured position.

18. A sterilizable connector for use in processing blood or other fluids, which connector comprises in combination:

a. a male body element;

b. a female body element;

c. the male and female body elements couplingly engaged in a first extended position, and, thereafter, in a second matingly engaged position which permits the passage of fluid therethrough;

d. means to secure the male and female body elements together when the elements are placed in the matingly engaged position;

e. the male and female body elements each characterized by a coaxial passageway therethrough, the passageway having a one end and another end, one end of each element and passageway adapted to be connected to a connector or fluid source;

f. a male septum at the other end of the male body element, the male septum composed of a resilient material and adapted to be punctured by a needle, the male septum closing the end of the male passageway at the other end, and slidably engaged with the interior surface of the female element;

g. a female septum closing the other end of the female passageway and positioned within the female passageway a sufficient distance to permit the female and male body elements to be placed in an extended position, the female septum composed of a resilient material and adapted to be punctured by a needle, and slidably engaged for movement in a fluid-tight manner within the female passageway, the face surfaces of the septums being free of adhesive material; and

h. a septum-puncturing hollow needle element within the female body element passageway, the interior of the needle providing fluid-flow communication with the one end of the female body element passageway, whereby on movement of the male or female body elements toward each other from the extended position to the engaged position, the female septum is slidably moved by the male septum backwardly against the needle element, which punctures the male and female septa, and in the engaged position, provides a passageway through the connector.

19. The connector of claim 18 wherein the connector is composed of a heat-sterilizable polymeric material.

20. The connector of claim 18 wherein the male and female septa are composed of a heat-sterilizable silicone resin material.

21. The connector of claim 18 wherein the male septum is slidably engaged in a nonfluid-tight manner within the female passageway.

22. The connector of claim 18 wherein the male and female elements are contoured to secure the elements in a frictional interlocking relationship in the engaged position.

23. The connector of claim 18 which includes a locking means to secure the male and female elements together in the engaged position.

24. The connector of claim 18 wherein the female septum is a sterilizable polymeric cup-shaped element.

25. The connector of claim 18 wherein the female septum is a polymeric element having at least one circumferential extending ring on the outer surface thereof to form a fluid-tight slidable seal with the interior surface of the female element.

26. The connector of claim 18 wherein the female septum has a contoured cup-like form to permit the movement of the female septum material outwardly within the female passageway when the female septum is punctured by the needle element.

27. The connector of claim 18 wherein the male septum is engaged in a slidable fluid-tight manner within the passageway of the female element.

28. The connector of claim 27 wherein the male septum is composed of a polymeric material having at least one circumferentially extending ring on the outer surface thereof to form a fluid-tight slidable seal within the interior surface of the female element.

29. The connector of claim 18 wherein the faces of the male and female septa in the extended position are in contacting engagement.

30. A blood bag system which comprises a processing bag and one or more reservoirs with associated tubing for the transfer of blood or solutions, which system includes one or more of the connectors of claim 18 to provide for the transfer of blood or solutions.

31. A polymeric sterilizable connector for use in processing blood, which connector comprises in combination:

a. an elongated tubular male body element formed of a sterilizable polymer;

b. an elongated tubular female body element formed of a sterilizable polymer;

c. the male and female body elements couplingly engaged in a first extended position and adapted to be engaged in a second matingly engaged position;

d. means to secure the male and female body elements together when the elements are in the second matingly engaged position;

e. the male and female body elements each characterized by an elongated coaxial passageway therethrough, the elements having a one end and another end, one end of each element and passageway adapted to be connected to tubing or a fluid source;

f. a polymeric male septum enclosing the other end of the male body element, the male septum adapted to be punctured by a needle, the male septum closing in a fluid-tight manner the other end of the male passageway, and slidably engaged in a fluid-right manner with the interior surface of the female element;

g. a polymeric female septum positioned within the female passageway in the first extended position, the female septum adapted to be punctured by a needle, and slidably engaged in a fluid-tight manner within the female passageway, the face surfaces of the septums being free of adhesive material; and

h. a septum-puncturing needle longitudinally positioned within the female body element passageway, the interior of the needle providing fluid-flow communication with one end of the female body element passageway, the other puncturing end of the needle positioned and spaced slightly apart from the wall of the female septum in the first extended position, whereby after sterilization of the connector in the first extended position, and on movement of the male and female body elements toward each other, the needle element punctures the male and female septa, and the female septum is pushed backwardly to place the male and female septa in a close fitting relationship to provide a sterile fluid passageway through the connector.

32. The connector of claim 31 wherein the connector is formed of a heat-sterilizable polymeric material, and the male and female septa are formed of a puncturable heat-sterilizable polymeric material.

33. The connector of claim 31 wherein the male and female elements are tapered so as to provide a frictional inter-locking relationship when moved from a first extended to a second engaged position.

34. The connector of claim 31 wherein the male and female septa have faces which are in a close contacting relationship in the first extended position.

35. The connector of claim 31 wherein the male and female septa are composed of molded heat-sterilizable polymers subject to sterilization at temperatures of above about 400°

F.

36. The connector of claim 31 wherein the male and female septa are composed of a molded resilient polymer, and have a plurality of mold 0-ring ridges about the external surfaces thereof to permit slidable movement in a fluid-tight manner.