Aseptic connector and fluid delivery system using such an aseptic connector

• US 6,096,011 A
• Filed: 01/29/1998
• Issued: 08/01/2000
• Est. Priority Date: 01/29/1998
• Status: Expired due to Term

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Trombley, Frederick W. III, Jaecklein, William J., Hirschman, Alan D., Pomaybo, Amy
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Rodriguez, Cris L.
• Application Number:
  US09/015,175
• Time in Patent Office: 915 Days
• Field of Search: 604/256, 604/246, 604/247, 604/249, 604/905, 604/533, 604/537, 604/538, 604/539, 604/283, 604/48, 604/500, 604/19, 251/149
• US Class Current: 604/256
• 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

An aseptic connector comprises a first member and a second member. The first member preferably includes a resilient septum, and the second member preferably includes a penetrating member. Preferably, the septum is formed from an elastomeric material such as a silicone elastomer. The penetrating member preferably includes an extending penetrating element to penetrate the resilient septum. The aseptic connector further comprises a resilient sealing element that contacts the penetrating member and one of an inner wall of the first member and an inner wall of the second member to create a seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member. The seal created is suitable to withstand relatively high pressures (for example, those experienced during the injection of contrast media in CT procedures). A fluid delivery system comprising at least a first aseptic connector as described above is also provided.

Claims

1. A patient interface for connection to a fluid delivery system comprising a first member of an aseptic connector, the first member comprising an inner wall and a resilient septum, the patient interface comprising:

a second member of the aseptic connector operable to engage the first member to create a seal, the second member comprising an inner wall and a penetrating member having an abutment shoulder, the penetrating member operable to penetrate the resilient septum of the first member;

a resilient sealing element that contacts the penetrating member and one of the inner wall of the first member and the inner wall of the second member to create a seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member, the resilient sealing element comprising an elastomeric member that is axially compressed by the abutment shoulder when the first member and the second member are brought together to form the seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member;

a tubing in fluid connection with the second member; and

a unidirectional flow device in fluid connection with the tubing between the second member and a patient.

2. The patient interface of claim 1, further comprising a catheter in fluid connection with the unidirectional flow device.

3. The patient interface of claim 1 wherein the unidirectional flow device comprises a check valve.

4. A method of delivering fluid to a patient, comprising the following steps:

providing a fluid delivery system comprising a pump system and a first member of an aseptic connector in fluid connection with the pump system;

providing a patient interface comprising a patient interface end, a second member of the aseptic connector and a unidirectional flow device disposed between the patient interface end and the second member, the first and second members of the aseptic connector cooperable to form a seal;

connecting the patient interface end of the patient interface to the patient;

connecting the second member of the aseptic connector on the patient interface to the first member of the aseptic connector; and

activating the pump system to deliver fluid to the patient.

5. The method of claim 4, further comprising the steps of:

deactivating the pump system to terminate delivery of fluid to the patient;

disconnecting the patent interface end of the patient interface from the patient;

disconnecting the second member of the aseptic connector on the patient interface from the first member of the aseptic connector; and

discarding the patient interface.

6. The method of claim 5, further comprising the steps of:

providing a new patient interface;

connecting the new patient interface to the patient and to the fluid delivery system; and

activating the pump system to deliver fluid to the patient.

7. The method of claim 4 wherein the first member of the aseptic connector comprises an inner wall and a resilient septum and the second member of the aseptic connector comprises an inner wall and a penetrating member, the penetrating member operable to penetrate the resilient septum when the second member of the aseptic connector on the patient interface is connected to the first member of the aseptic connector.

8. The method of claim 7 wherein the aseptic connector further comprises a resilient sealing element that contacts the penetrating member and one of the inner wall of the first member and the inner wall of the second member to create a seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member.

9. The method of claim 8 wherein the resilient sealing element comprises an elastomeric member that is axially compressed when the first member and the second member are brought together to form the seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member.

10. An aseptic connector comprising:

a first member comprising an inner wall and a resilient septum;

a second member comprising an inner wall and a penetrating member having an abutment shoulder, the penetrating member including an extending penetrating element to penetrate the resilient septum; and

a resilient sealing element that contacts the penetrating member and one of the inner wall of the first member and the inner wall of the second member to create a seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member, the seal thereby formed being suitable for use at relatively high pressures, the resilient sealing element comprising an elastomeric member that is axially compressed by the abutment shoulder when the first member and the second member are brought together to form the seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member.

11. The aseptic connector of claim 10 wherein the resilient septum has at least one generally circular enclosed end which is attached to the annular, elastomeric member, the generally circular end being penetrated by the penetrating element, the annular, elastomeric member being seated in a generally cylindrical seating chamber formed in the first member, the seating chamber having an inner wall having a diameter slightly greater than an outside diameter of the annular, elastomeric member, the seal being formed between penetrating element and the inner wall of the seating chamber.

12. The aseptic connector of claim 11 wherein the abutment shoulder is a radially outward extending shoulder on the penetrating member.

13. The aseptic connector of claim 12 wherein the annular, elastomeric member is extended in length to have a generally cylindrical shape.

14. The aseptic connector of claim 13, wherein the first member further comprises a first threaded section and the second member comprises a second threaded section, the first threaded section and the second threaded section being adapted to cooperate to securely and releasably connect the first member to the second member.

15. The aseptic connector of claim 10, wherein the first member further comprises a first threaded section and the second member comprises a second threaded section, the first threaded section and the second threaded section being adapted to cooperate to securely and releasably connect the first member to the second member.

16. A fluid delivery system for injecting a fluid into a patient, the fluid delivery system comprising:

a first aseptic connector comprising;

a first member comprising an inner wall and a resilient septum;

a second member comprising an inner wall and a penetrating member, the penetrating member comprising an extending penetrating element to penetrate the resilient septum; and

a resilient sealing element that contacts the penetrating member and one of the inner wall of the first member and the inner wall of the second member to create a seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member, the seal thereby formed being suitable for use at relatively high pressures; and

a pump system in fluid connection with one of the first member and the second member, the other of the first member and the second member being in fluid connection with the patient.

17. The fluid delivery system of claim 16, further comprising a dual check valve comprising an inlet, a first outlet and a second outlet, the other of the first member of the first aseptic connector and the second member of the first aseptic connector being connected to the first outlet of the dual check valve, the pump system being connected to the second outlet of the dual check valve, and a source of fluid being connected to the inlet of the dual check valve.

18. The fluid delivery system of claim 17, further comprising a second aseptic connector comprising a first member and a second member, one of the first member of the second aseptic connector and the second member of the second aseptic connector being connected to the inlet of the dual check valve, the other of the first member of the second aseptic connector and the second member of the second aseptic connector being connected to the source of fluid.

19. The fluid delivery system of claim 16 wherein the fluid delivery system further comprises a check valve in fluid connection between the patient and the other of the first member and the second member.

20. The fluid delivery system of claim 16 wherein the resilient sealing element comprises an annular, elastomeric member that is axially compressed when the first member and the second member are brought together to form the seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member.

21. The fluid delivery system of claim 20 wherein the penetrating member includes an abutment shoulder that axially compresses the annular, elastomeric member when the first member and the second member a brought together.

22. The fluid delivery system of claim 21 wherein the resilient septum has at least one generally circular enclosed end which is attached to the annular, elastomeric member, the generally circular end being penetrated by the penetrating element, the annular, elastomeric member being seated in a generally cylindrical seating chamber formed in the first member, the seating chamber having an inner wall having a diameter slightly greater than an outside diameter of the annular, elastomeric member, the seal being formed between penetrating element and the inner wall of the seating chamber.

23. The fluid delivery system of claim 22 wherein the abutment shoulder is a radially outward extending shoulder on the penetrating members.

24. The fluid delivery system of claim 23 wherein the annular, elastomeric member is extended in length to have a generally cylindrical shape.

25. The fluid delivery system of claim 24, wherein the first member further comprises a first threaded section and the second member comprises a second threaded section, the first threaded section and the second threaded section being adapted to cooperate to securely and releasably connect the first member to the second member.

26. The fluid delivery system of claim 16, wherein the first member further comprises a first threaded section and the second member comprises a second threaded section, the first threaded section and the second threaded section being adapted to cooperate to securely and releasably connect the first member to the second member.

27. An aseptic connector comprising:

a first member comprising a first threaded section, an inner wall and a resilient septum;

a second member comprising a second threaded section, an inner wall and a penetrating member operable to penetrate the resilient septum; and

a resilient sealing element that contacts the penetrating member and one of the inner wall of the first member and the inner wall of the second member to create a seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member, wherein the first threaded section and the second threaded section cooperate to securely and releasably connect the first member to the second member.

28. The aseptic connector of claim 27 wherein the resilient sealing element comprises an elastomeric member that is axially compressed when the first member and the second member are brought together to form the seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member.

29. The aseptic connector of claim 28 wherein the penetrating member comprises an abutment shoulder that axially compresses the elastomeric member when the first member and the second member are brought together.

30. A patient interface for connection to a fluid delivery system comprising a first member of an aseptic connector, the first member comprising a first threaded section, the patient interface comprising:

a second member of the aseptic connector operable to engage the first member to create a seal, the second member comprising a second threaded section operable to engage the first threaded section to securely and releasably connect the first member to the second member;

a tubing in fluid connection with the second member; and

a unidirectional flow device in fluid connection with the tubing between the second member and a patient.

31. The patient interface of claim 30 wherein the first member further comprises an inner wall and a resilient septum and the second member further comprises an inner wall and a penetrating member, the penetrating member operable to penetrate the resilient septum when the first threaded section and the second threaded section are brought together to connect the first member to the second member.

32. The patient interface of claim 31, further comprising a resilient sealing element that contacts the penetrating member and one of the inner wall of the first member and the inner wall of the second member to create a seal between the penetrating member and one of the inner wall of the first member and the inner wall of the second member.