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Title:
CONNECTOR ASSEMBLY, CONNECTORS THEREFOR, AND METHOD
Document Type and Number:
WIPO Patent Application WO/2019/070389
Kind Code:
A2
Abstract:
A first connector includes a probe defining a flow aperture, and a first wiping and sealing member. A second connector includes a second wiping and sealing member and is connectable to the first connector. During connection, the probe and/or first wiping and sealing member moves between first and second positions, the first wiping and sealing member wipes the probe and maintains a substantially fluid-tight seal therebetween, the probe moves through the second wiping and sealing member, and the second wiping and sealing member engages the probe, forms a substantially fluid-tight seal therebetween, and wipes the probe. In the second position, the aperture of the probe is in fluid communication with an interior of the second connector to thereby allow the passage of substance from the first connector, through the probe, and into the second connector, or vice versa.

Inventors:
PY DANIEL (US)
Application Number:
PCT/US2018/051251
Publication Date:
April 11, 2019
Filing Date:
September 14, 2018
Export Citation:
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Assignee:
MAEJ LLC (US)
International Classes:
F16L13/10
Attorney, Agent or Firm:
REINER, Kevin, L. et al. (US)
Download PDF:
Claims:
What is claimed is:

1. A connector assembly comprising:

a first connector including a probe defining at least one aperture in fluid communication with an interior of the probe, and a first wiping and sealing member that engages the probe and forms a substantially fluid-tight seal therebetween, wherein the probe and/or first wiping and sealing member is movable between first and second positions, and during movement between the first and second positions, the first wiping and sealing member wipes the probe and maintains a substantially fluid-tight seal therebetween; and

a second connector including a second wiping and sealing member;

wherein the first and/or second connectors is movable between a disconnected position where the first and second connectors are disconnected, and a connected position where the first and second connectors are connected; and in the connected position and/or during movement between the disconnected and connected positions, (i) during movement of the first wiping and sealing member and/or probe between the first and second positions, the probe moves through the second wiping and sealing member, and the second wiping and sealing member engages the probe, forms a substantially fluid-tight seal therebetween, and wipes the probe, and (ii) in the second position, the at least one aperture of the probe is in fluid communication with an interior of the second connector to thereby (a) allow the passage of substance from the first connector, through the probe, and into the second connector, and/or (b) allow the passage of substance from the second connector, and through the probe and into the first connector.

2. A connector assembly as defined in claim 1, wherein the first wiping and sealing member extends about the probe, and forms an annular or circumferential, substantially fluid- tight seal therebetween.

3. A connector assembly as defined in claim 1 or 2, wherein in the first position, the first wiping and sealing member extends axially from a first location at approximately a distal end of the probe and/or distally to the at least one aperture to a second location proximal the at least one aperture.

4. A connector assembly as defined in claim 3, wherein the first wiping and sealing member maintains a substantially fluid-tight seal that extends annularly or circumferentially about the probe, and extends axially from the first location to the second location.

5. A connector assembly as defined in any of the preceding claims, wherein the first connector further includes a biasing member that normally biases the first wiping and sealing member toward the first position.

6. A connector assembly as defined in claim 5, wherein the biasing member includes a coil spring.

7. A connector assembly as defined in claim 5 or 6, wherein movement of the first wiping and sealing member or probe in the direction of the first position to the second position is against the bias of the biasing member.

8. A connector assembly as defined in any of the preceding claims, wherein the first connector includes a stop configured to engage the first wiping and sealing member in the first position, wherein the stop prevents further distal movement of the first wiping and sealing member or probe relative to the other when the first connector is in the disconnected position.

9. A connector assembly as defined in any of the preceding claims, wherein the first wiping and sealing member is engageable by or with the second connector, and is movable between the first and second positions upon or after movement into the connected position.

10. A connector assembly as defined in any of the preceding claims, wherein in the connected position, the first and second wiping and sealing members form a substantially fluid- tight seal therebetween.

11. A connector assembly as defined in claim 10, wherein the first wiping and sealing member defines a first distal sealing surface, the second wiping and sealing member defines a second distal sealing surface, and in the connected position, the first and second distal sealing surfaces form a substantially fluid-tight seal therebetween.

12. A connector assembly as defined in claim 12, wherein the first distal sealing surface defines a first angle with respect to an axis of the connector assembly, the second distal sealing surface defines a second angle with respect to the axis, and one of the first or second angles is greater than the other to thereby direct substance at the interface of the first and second distal sealing surfaces radially outwardly during movement of the first and second connectors from the disconnected position into the connected position and/or in the connected position.

13. A connector assembly as defined in any of the preceding claims, wherein each of the first wiping and sealing member and second wiping and sealing member is formed of one or more elastic materials.

14. A connector assembly as defined in claim 13, wherein each of the first and second wiping and sealing members are formed of one or more elastic materials selected from a group including thermoplastic elastomers and silicone.

15. A connector assembly as defined in any of the preceding claims, wherein the second wiping and sealing member defines a normally-closed aperture extending therethrough, and in the disconnected position, the normally-closed aperture defines a substantially fluid-tight seal, and in the connected position and/or during movement between the disconnected and connected positions, during movement of the second wiping and sealing member and/or probe relative to the other, the probe is received into the normally-closed aperture, and the second wiping and sealing member wipes the probe and maintains a substantially fluid-tight seal therebetween.

16. A connector assembly as defined in claim 15, wherein the normally-closed aperture extends axially through the second wiping and sealing member from an exterior to an interior surface thereof.

17. A connector assembly as defined in claim 16, wherein the normally-closed aperture includes a plurality of normally-closed slots that extend radially outwardly from an approximate center point or axis of symmetry of the second wiping and sealing member and are angularly spaced relative to each other.

18. A connector assembly as defined in claim 17, wherein the normally-closed slots extend axially from the exterior to the interior surface of the second wiping and sealing member.

19. A connector assembly as defined in claim 18, wherein the normally-closed slots include three slots approximately equally spaced relative to each other.

20. A connector assembly as defined in any of claims 15 to 19, wherein the second wiping and sealing member is formed of one or more elastomeric materials, and is radially compressed and/or radially displaced within the second connector to close the normally closed aperture and form the substantially fluid-tight seal.

21. A connector assembly as defined in claim 20, wherein the second connector includes a support that extends about a periphery of the second wiping and sealing member and compresses and/or displaces the second wiping and sealing member radially inwardly to close the normally-closed aperture and form the substantially fluid-tight seal.

22. A connector assembly as defined in claim 21, wherein the support includes a plurality of compressive sections that are angularly spaced relative to each other and extend radially inwardly in engagement with the second wiping and sealing member to close the normally-closed aperture and form the substantially fluid-tight seal.

23. A connector assembly as defined in claim 22, wherein each compressive section defines an approximate arcuate shape.

24. A connector assembly as defined in claim 23, wherein the normally-closed aperture includes a plurality of normally-closed slots that extend radially outwardly from an approximate center point or axis of symmetry of the second wiping and sealing member, and each compressive section extends angularly between respective angularly spaced slots.

25. A connector assembly as defined in claim 24, wherein the normally-closed slots extend axially from the exterior to the interior surface of the second wiping and sealing member.

26. A connector assembly as defined in any of claims 15 to 25 , wherein the normally-closed aperture defines a length approximately equal to or greater than a distance between a distal end of the probe and a proximal end of the at least one aperture of the probe.

27. A connector assembly as defined in any of claims 15 to 26, wherein the second connector defines an internal fluid passageway in fluid communication with a proximal end of the normally-closed aperture that is sealed with respect to ambient atmosphere.

28. A connector assembly as defined in claim 27, further comprising a second conduit defining an internal fluid passageway that is sealed with respect to ambient atmosphere and is in fluid communication with the internal fluid passageway of the second connector.

29. A connector assembly as defined in any of the preceding claims, wherein the first connector defines an internal fluid passageway in fluid communication with the at least one aperture of the probe that is sealed with respect to ambient atmosphere.

30. A connector assembly as defined in claim 29, further comprising a first conduit defining an internal fluid passageway that is sealed with respect to ambient atmosphere and is in fluid communication with the internal fluid passageway of the first connector.

31. A connector assembly as defined any of claims 15 to 20, wherein the second wiping and sealing member defines a support extending about a periphery of the second wiping and sealing member, and an elastomeric body received within the support and defining the normally-closed aperture.

32. A connector assembly as defined in claim 31, wherein support and elastomeric body are co-molded to each other.

33. A connector that is connectable to a second connector including a second wiping and sealing member to form a connector assembly, the connector comprising:

a probe defining at least one aperture in fluid communication with an interior of the probe, and a first wiping and sealing member that engages the probe and forms a substantially fluid- tight seal therebetween, wherein (i) the probe and/or first wiping and sealing member is movable between first and second positions; (ii) during movement between the first and second positions, the first wiping and sealing member wipes the probe and maintains a substantially fluid-tight seal therebetween; (iii) the connector is movable between a disconnected position where it is not connected to the second connector, and a connected position where it is connected to the second connector; (iv) the connector is configured such that in the connected position and/or during movement between the disconnected and connected positions, during movement of the first wiping and sealing member and/or probe between the first and second positions, the probe moves through the second wiping and sealing member of the second connector and is configured such that the second wiping and sealing member engages the probe, forms a substantially fluid- tight seal therebetween, and wipes the probe, and is further configured such that in the second position, the at least one aperture of the probe is in fluid communication with an interior of the second connector to thereby (a) allow the passage of substance from the connector, through the probe, and into the second connector, and/or (b) allow the passage of substance from the second connector, and through the probe and into the connector.

34. A connector as defined in claim 33, wherein the first wiping and sealing member extends about the probe, and forms an annular or circumferential, substantially fluid-tight seal therebetween.

35. A connector as defined in claim 33 or 34, further comprising: a biasing member that normally biases the first wiping and sealing member toward the first position; and a stop that engages the first wiping and sealing member in the first position and prevents further distal movement of the first wiping and sealing member relative to the probe when the connector is in the disconnected position.

36. A connector as defined in any of claims 33 to 35, wherein the second wiping and sealing member defines a second distal sealing surface, and the connector further comprises: a distal sealing surface defined by the wiping and sealing member that is configured to engage the second distal sealing surface of the second wiping and sealing member in the connected position and form a substantially fluid-tight seal therebetween.

37. A connector as defined in claim 36, wherein the second wiping and sealing surface defines a second angle with respect to an axis thereof, wherein: the distal sealing surface defines a first angle with respect to an axis of the connector that is greater than or less then the second angle of the second connector and configured to direct fluid at an interface of the first and second distal sealing surfaces radially outwardly during movement of the connector from the disconnected position into the connected position or in the connected position.

38. A connector as defined in any of claims 33 to 37, in further combination with a second connector to form a connector assembly, wherein the second connector includes a second wiping and sealing member.

39. A connector that is connectable to another connector, wherein the other connector includes a probe defining at least one aperture in fluid communication with an interior of the probe, and a wiping and sealing member that engages the probe and forms a substantially fluid- tight seal therebetween, wherein the probe and/or wiping and sealing member is movable between first and second positions, and during movement between the first and second positions, the wiping and sealing member wipes the probe and maintains a substantially fluid-tight seal therebetween, the connector comprising:

a wiping and sealing member and a sealed conduit or chamber on an interior side of the wiping and sealing member; wherein the connector is movable between a disconnected position where it is not connected to the other connector, and a connected position where it is connected to the other connector; the wiping and sealing member of the connector is configured such that in the connected position and/or during movement between the disconnected and connected positions, during movement of the probe and/or wiping and sealing member of the other connector between the first and second positions, the probe moves through the wiping and sealing member, and the wiping and sealing member forms a substantially fluid-tight seal therebetween and wipes the probe, and is further configured such that in the second position, the at least one aperture of the probe is in fluid communication with the conduit or chamber thereof to (a) allow the passage of substance through the probe and into the conduit or chamber of the connector; and/or (b) allow the passage of substance from the connector and into the probe.

40. A connector as defined in claim 39, wherein the wiping and sealing member defines a normally-closed aperture extending therethrough, and in the disconnected position, the normally-closed aperture defines a substantially fluid-tight seal, and is configured such that in the connected position and/or during movement between the disconnected and connected positions, during movement of the wiping and sealing member and/or probe relative to the other, the probe is received into the normally-closed aperture, and the wiping and sealing member wipes the probe and maintains a substantially fluid-tight seal therebetween.

41. A connector as defined in claim 40, wherein the normally-closed aperture extends axially through the wiping and sealing member from an exterior to an interior surface thereof.

42. A connector as defined in claim 40 or 41, wherein the normally-closed aperture includes a plurality of normally-closed slots that extend radially outwardly from an approximate center point or axis of symmetry of the wiping and sealing member and are angularly spaced relative to each other.

43. A connector as defined in claim 42, wherein the normally-closed slots extend axially from an exterior to an interior surface of the wiping and sealing member.

44. A connector as defined in claim 42 or 43, wherein the normally-closed aperture includes three slots approximately equally spaced relative to each other.

45. A connector assembly as defined in any of claims 40 to 44, wherein the wiping and sealing member is formed of one or more elastomeric materials, and is radially compressed and/or radially displaced within the connector to close the normally-closed aperture and form the substantially fluid-tight seal.

46. A connector as defined in any of claims 42 to 45, further comprising a support that extends about a periphery of the wiping and sealing member that compresses and/or displaces the wiping and sealing member radially inwardly to close the normally-closed aperture and form the substantially fluid-tight seal.

47. A connector as defined in claim 46, wherein the support includes a plurality of compressive sections that are angularly spaced relative to each other and extend radially inwardly in engagement with the wiping and sealing member to close the normally-closed aperture and form the substantially fluid-tight seal.

48. A connector as defined in claim 47, wherein each compressive section defines an approximate arcuate shape.

49. A connector as defined in claim 47 or 48, wherein each compressive section extends angularly between respective angularly spaced slots.

50. A connector assembly as defined in any of claims 40 to 49, wherein the normally- closed aperture defines a length approximately equal to or greater than a distance between a distal end of the probe and a proximal end of the at least one aperture of the probe.

51. A method comprising the following steps:

moving first and second connectors from disengaged to engaged positions;

wiping a probe of the first connector with a first wiping and sealing member of the first connector, and maintaining a substantially fluid-tight seal between the probe and first wiping and sealing member during said wiping;

penetrating a normally-closed opening of a second wiping and sealing member of the second connector with the probe of the first connector, and during such penetration, wiping the probe with the second wiping and sealing member, and maintaining a substantially fluid-tight seal between the probe and second wiping and sealing member; and

penetrating a sufficient portion of the probe through the second wiping and sealing member to place at least one flow aperture of the probe in fluid communication with an interior of the second connector.

52. A method as defined in claim 41, further comprising disconnecting the first and second connectors, wherein the disconnecting includes (i) moving the probe and/or second wiping and sealing member relative to the other, and during such relative movement, maintaining a substantially fluid-tight seal between the probe and second wiping and sealing member, and wiping the probe with the second wiping and sealing member; (ii) moving the probe and/or first wiping and sealing member relative to the other, and during such relative movement, maintaining a substantially fluid-tight seal between the probe and first wiping and sealing member, and wiping the probe with the first wiping and sealing member; (iii) receiving the at least one flow aperture of the probe within the first wiping and sealing member, and maintaining a substantially fluid-tight seal between the at least one flow aperture and the first wiping and sealing member to seal the at least one flow aperture within the first connector; and (iv) disengaging the first and second connectors.

53. A method as defined in claim 51 or 52, further comprising (a) allowing substance to flow from the probe of the first connector, through the at least one flow aperture thereof and into the interior of the second connector and/or (b) allow the passage of substance from the second connector, and through the probe and into the first connector.

54. A method as defined in any of claims 51 to 53, further comprising during flow of substance between the first connector and the second connector, sealing the substance from the ambient atmosphere within the first and second connectors.

55. A method as defined in any of claims 51 to 54, wherein surfaces of the first and second connectors that contact substance flowing therethrough are sealed with respect to ambient atmosphere.

56. A method as defined in any of claims 51 to 55, wherein surfaces of the first and second connectors that contact substance flowing therethrough are aseptic or sterile.

57. A method as define in any of claims 51 to 56, further comprising (i) engaging the first and second connectors in fluid communication with each other; (ii) disengaging the first and second connectors such that they are not in fluid communication with each other; and (iii) repeating steps (i) and (ii) one or more times, wherein surfaces of the first and second connectors that contact substance flowing therethrough are sealed with respect to ambient atmosphere and maintained aseptic or sterile throughout steps (i) and (ii) and the repetition of such steps.

58. A method as defined in any of claims 51 to 57, further comprising preventing further distal movement of the first wiping and sealing member or probe relative to the other when the first connector is in the disengaged position.

59. A method as defined in any of claims 51 to 58, further comprising upon or after movement of the first or second connector into the engaged position, engaging the first wiping and sealing member with the second connector, and moving the first wiping and sealing member and/or probe between first and second positions.

60. A method as defined in any of claims 51 to 59, further comprising upon or after movement of the first or second connector into the engaged position, forming a substantially fluid-tight seal between the first and second wiping and sealing members.

61. A method as defined in any of claims 51 to 60, further comprising forming a substantially fluid-tight seal between distal sealing surfaces of the first and second wiping and sealing members.

62. A method as defined in claim 61, further comprising allowing or directing fluid between or at an interface of the distal sealing surfaces to flow radially outwardly during movement of the first and/or second connectors into the engaged position or in the engaged position and, in turn, forming annular, substantially fluid-tight seal between the distal sealing surfaces.

63. A method as defined in any of claims 51 to 62, further comprising penetrating the probe through angularly- spaced, normally-closed slots of the normally-closed opening and maintaining a substantially fluid-tight seal therebetween during penetration and in the engaged position.

64. A method as defined in any of claims 51 to 63, further comprising maintaining an annular or circumferential and axially-extending fluid-tight seal between the second wiping and sealing member and probe during movement between the first and second positions and in the engaged position.

65. A method as defined in claim 64, further comprising maintaining the annular or circumferential and axially-extending fluid-tight seal along an axial length of the probe at least equal to an axial distance between a distal end of the probe and a proximal side of the at least one flow aperture of the probe.

66. A method as defined in any of claims 51 to 65, further comprising maintaining the normally-closed opening of the second wiping and sealing member normally closed with a plurality of compressive sections that are angularly spaced relative to each other and extend radially inwardly in engagement with the second wiping and sealing member.

67. A connector assembly comprising:

first means for connecting including second means for penetrating and transferring fluid and defining at least one aperture in fluid communication with an interior thereof, and third means for wiping and sealing the second means and forming a substantially fluid-tight seal therebetween, wherein the second and/or third means is movable between first and second positions, and during movement between the first and second positions, the third means wipes the second means and maintains a substantially fluid-tight seal therebetween; and

fourth means for connecting including fifth means for wiping and sealing;

wherein the first and/or fourth means is movable between a disconnected position where the first and fourth means are disconnected, and a connected position where the first and fourth means are connected; and in the connected position and/or during movement between the disconnected and connected positions, (i) during movement of the second and/or third means between the first and second positions, the second means moves through the fifth means, and the fifth means engages the second means, maintain a substantially fluid-tight seal therebetween, and wipes the second means, and (ii) in the second position, the at least one aperture of the second means is in fluid communication with an interior of the fourth means to thereby (a) allow the passage of substance from the first means, through the second means and into the fourth means, and/or (b) allow the passage of substance from the second connector, and through the probe and into the first connector.

68. A connector assembly as defined in claim 67, wherein the first means includes a first connector, the second means includes a probe, the third means includes a first wiping and sealing member, the fourth means includes a second connector, and the fifth means includes a second wiping and sealing member.

Description:
CONNECTOR ASSEMBLY, CONNECTORS THEREFOR, AND METHOD

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit under 35 U.S.C. § 119 of co-pending U.S. application no. 62/558,652 filed September 14, 2017 and entitled "Connector Assembly, Connectors Therefor, and Method," which is incorporated by reference in its entirety as if fully set forth herein.

FIELD OF THE DISCLOSURE

[0002] The present disclosure relates to connector assemblies for allowing the flow of fluids or other substances therethrough, and more particularly, to connector assemblies that maintain the substance flowing therethrough, and the surfaces thereof that contact the substance flowing therethrough, sealed with respect to the ambient atmosphere, and/or that can maintain the substance flowing therethrough aseptic or sterile, and to connectors for use in such connector assemblies and to methods of making and using such connectors and connector assemblies.

BACKGROUND INFORMATION

[0003] A typical prior art fluid connector includes a male connector that is received within a female connector to place the two connectors in fluid communication with each other. The male and female connectors may be threadedly engaged, snap fit, or otherwise releasably connected to each other to allow for interconnection and disconnection. Each connector is coupled in fluid communication with a respective fluid passageway, such as a tube or fluid chamber, in order to place the fluid passageways in fluid communication with each other and allow the passage of fluids therebetween.

[0004] During conventional aseptic processing, product and/or containers are open to the environment, and thus subject to microbial contamination. The predominant cause of contamination in conventional aseptic processing is acknowledged to be the result of human activity within the processing environment during either initial setup or an interventional activity (including both inherent and corrective interventions) during aseptic processes. Following human activity and interventions, contaminants can settle on/in open containers, closures and exposed product contact parts. Risks are identified, assessed, evaluated and controlled through application of Quality Risk Management Principles ("QRM"). The success of this approach depends on accurate assessment of risk and appropriate controls, such as standard operating procedures, equipment, etc. Once deposited, microbial contaminants can enter the product unless protection is provided to containers, closures, product and critical surfaces. The open container-closures exposure is also subject to the capacity of the HEPA filters to eliminate viable and no n- viable particles.

[0005] Prior art fluid connectors may not prevent the contamination of fluids passing through them. For example, prior to interconnection of the male and female connectors, the fluid- contacting surfaces thereof can be exposed to the ambient atmosphere and subjected to microbial or other contamination, such as through contact with airborne germs and/or by contact with contaminated surfaces. One approach to preventing such contamination is to wipe the fluid- contacting surfaces of the male and female connectors with an alcohol wipe or other disinfectant prior to interconnection. One drawback of this approach is that the fluid-contacting surfaces may become contaminated after the wipe is applied but prior to interconnection of the male and female connectors. Another drawback is that it can be time consuming and considered a nuisance, and therefore unreliable in practice.

[0006] Aseptic or sterile fluids can be subjected to microbial contamination when passed through such prior art connectors. Such contamination can give rise to significant problems. If used in a hospital or other medical facility, such as to transfer sterile drugs or other fluids intended for intravenous injection, for example, any such contamination can lead to blood stream infections, serious illnesses, and death by nosocomial infections. In food processing applications, on the other hand, it may be necessary to connect fluid conduits, for example, in order to transfer sterile or aseptic fluids from one passageway to another. If the fluids are contaminated upon passage through a fluid connector, this can lead to contamination of previously sterile or aseptic food products, and if such contaminated products are ingested, they can cause infections and/or illnesses. In industrial applications, it may be necessary to prevent a toxic fluid from passing through a connector and contaminating the ambient atmosphere, an operator handling the connector, and/or other surfaces that might be located external to the connector. If the fluid-contacting surfaces of the connector are exposed to human contact, or surfaces that come into human contact, for example, this can lead to possible injury and/or illnesses. SUMMARY

[0007] It is an object to overcome one or more of the above-described drawbacks and/or disadvantages of the prior art.

[0008] In accordance with a first aspect, a connector assembly comprises a first connector including a probe defining at least one aperture in fluid communication with an interior of the probe, and a first wiping and sealing member that engages the probe and forms a substantially fluid-tight seal therebetween. The probe and/or first wiping and sealing member are movable between first and second positions. During movement between the first and second positions, the first wiping and sealing member wipes the probe and maintains a substantially fluid-tight seal therebetween. The connector assembly further comprises a second connector including a second wiping and sealing member. The first and/or second connectors are movable between a disconnected position where they are disconnected, and a connected position where they are connected. During connection, (i) during movement of the first wiping and sealing member and/or probe between the first and second positions, the probe moves through the second wiping and sealing member, and the second wiping and sealing member engages the probe, forms a substantially fluid-tight seal therebetween, and wipes the probe, and (ii) in the second position, the aperture(s) of the probe are in fluid communication with an interior of the second connector to thereby allow the passage of substance from the first connector, through the probe, and into the second connector, or vice versa. That is, in at least some embodiments, the substance can pass from the second connector and into and through the probe and the first connector.

[0009] In some embodiments, the first wiping and sealing member extends about the probe, and forms an annular or circumferential, substantially fluid-tight seal therebetween. In some such embodiments, in the first position, the first wiping and sealing member extends axially from a first location at approximately the distal end of the probe, or at least distal to the probe aperture(s), to a second location proximal the aperture(s). In some such embodiments, the first wiping and sealing member maintains a substantially fluid-tight seal that extends annularly or circumferentially about the probe, and extends axially from the first location to the second location.

[0010] In some embodiments, the first connector further includes a spring or other biasing member that normally biases the first wiping and sealing member toward the first position. In some such embodiments, the spring is a coil spring. In some embodiments, the first connector includes a stop that engages the first wiping and sealing member in the first position, and prevents further distal movement of the first wiping and sealing member relative to the probe when the first connector is in the disconnected position. In some such embodiments, movement of the first wiping and sealing member or probe in the direction of the first position to the second position is against the bias of the spring. In some embodiments, the first wiping and sealing member is engageable by the second connector, and is movable between the first and second positions upon or after movement of the second connector into the connected position.

[0011] In some embodiments, in the connected position, the first and second wiping and sealing members form a substantially fluid-tight seal therebetween. In some such embodiments, the first wiping and sealing member defines a first distal sealing surface, and the second wiping and sealing member defines a second distal sealing surface. In the connected position, the first and second distal sealing surfaces form a substantially fluid-tight seal therebetween. In some embodiments, the first distal sealing surface defines a first angle with respect to an axis of the connector assembly, and the second distal sealing surface defines a second angle with respect to the axis. One of the first or second angles is greater than the other to thereby direct fluid at the interface of the first and second distal sealing surfaces radially outwardly during movement of the first and second connectors from the disconnected position into the connected position or in the connected position.

[0012] In some embodiments, the second wiping and sealing member defines a normally- closed aperture extending therethrough. In the disconnected position, the normally-closed aperture defines a substantially fluid-tight seal. In the connected position, during movement of the second wiping and sealing member and/or probe relative to the other, the probe is received into the normally-closed aperture, and the second wiping and sealing member wipes the probe and maintains a substantially fluid-tight seal therebetween. In some embodiments, the normally- closed aperture extends axially through the second wiping and sealing member from an exterior to an interior surface thereof. In some embodiments, the aperture defines a normally-closed slot. In some embodiments, the normally-closed aperture includes a plurality of normally-closed slots that extend radially outwardly from an approximate center point or axis of symmetry of the second wiping and sealing member and are angularly spaced relative to each other. In some such embodiments, the normally-closed slots extend axially from the exterior to the interior surface of the second wiping and sealing member. In some such embodiments, the normally-closed slots include three slots approximately equally spaced relative to each other.

[0013] In some embodiments, the second wiping and sealing member is formed of one or more elastomeric materials. The second, elastomeric wiping and sealing member is radially compressed and/or displaced within the second connector to close the normally-closed aperture and form the substantially fluid-tight seal. In some such embodiments, the second connector includes a support that extends about a periphery of the second wiping and sealing member and compresses and/or displaces the second wiping and sealing member radially inwardly to close the normally-closed aperture and form the substantially fluid-tight seal. In some embodiments, the support includes a plurality of compressive sections that are angularly spaced relative to each other and extend radially inwardly in engagement with the second wiping and sealing member to close the normally-closed aperture and form the substantially fluid-tight seal. In some embodiments, each compressive section defines an approximate arcuate shape. In some embodiments, the normally-closed aperture includes a normally closed slot. In some embodiments, the normally-closed aperture includes a plurality of normally-closed slots that extend radially outwardly from an approximate center point or axis of symmetry of the second wiping and sealing member, and each compressive section extends angularly between respective angularly spaced slots. In some embodiments, the normally-closed slots extend axially from the exterior to the interior surface of the second wiping and sealing member. In some embodiments, the normally-closed aperture defines a length approximately equal to or greater than a distance between a distal end of the probe and a proximal end of the probe aperture.

[0014] In some embodiments, the second wiping and sealing member defines a support extending about a periphery of the second wiping and sealing member, and an elastomeric body received within the support and defining the normally-closed aperture. In some such embodiments, the support and elastomeric body are co-molded to each other.

[0015] In accordance with another aspect, a connector, such as a male connector, is connectable to a second connector, such as a female connector, to form a connector assembly. The second or female connector includes a second wiping and sealing member. The connector or male connector comprises a probe defining at least one aperture in fluid communication with an interior thereof, and a first wiping and sealing member that engages the probe and forms a substantially fluid-tight seal therebetween. The probe and/or first wiping and sealing member are movable between first and second positions. During movement between the first and second positions, the first wiping and sealing member wipes the probe and maintains a substantially fluid-tight seal therebetween. The connector is movable between a disconnected position where it is not connected to the second connector, and a connected position where it is connected to the second connector. The connector is configured such that in the connected position, during movement of the first wiping and sealing member or probe between the first and second positions, the probe moves through the second wiping and sealing member of the second connector and is configured such that the second wiping and sealing member engages the probe, forms a substantially fluid-tight seal therebetween, and wipes the probe. The connector is further configured such that in the second position, the aperture of the probe is in fluid communication with an interior of the second connector to thereby allow the passage of substance from the connector, through the probe, and into the second connector, or vice versa.

[0016] In some embodiments, the first wiping and sealing member extends about the probe, and forms an annular or circumferential, substantially fluid-tight seal therebetween. Some embodiments further comprise a spring or other biasing member that normally biases the first wiping and sealing member toward the first position. A stop engages the first wiping and sealing member in the first position and prevents further distal movement of the first wiping and sealing member relative to the probe when the connector is in the disconnected position.

[0017] In some embodiments, the connector further comprises a distal sealing surface defined by the wiping and sealing member. The distal sealing surface is configured to engage in the connected position a second distal sealing surface of a second wiping and sealing member of the second connector and form a substantially fluid-tight seal therebetween. In some such embodiments, the distal sealing surface defines a first angle with respect to an axis of the connector that is greater than or less than a second angle of the second distal sealing surface. The distal sealing surface is thereby configured to direct fluid at the interface of the first and second distal sealing surfaces radially outwardly during movement of the connector from a disconnected position into a connected position or in a connected position.

[0018] In accordance with another aspect, a connector, such as a female connector, is connectable to another connector, such as a male connector. The male or other connector includes a probe defining at least one aperture in fluid communication with an interior thereof, and a wiping and sealing member that engages the probe and forms a substantially fluid-tight seal therebetween. The probe and/or wiping and sealing member is movable between first and second positions. During movement between the first and second positions, the wiping and sealing member wipes the probe and maintains a substantially fluid-tight seal therebetween. The connector, such as the female connector, comprises a wiping and sealing member, and a sealed conduit or chamber on an interior side of the wiping and sealing member. The connector is movable between a disconnected position where it is not connected to the other connector, and a connected position where it is connected to the other connector. The wiping and sealing member of the connector is configured such that in the connected position, during movement of the probe or wiping and sealing member of the other connector between the first and second positions, the probe moves through the wiping and sealing member, and the wiping and sealing member engages the probe, forms a substantially fluid-tight seal therebetween, and wipes the probe. The connector is further configured such that in the second position, the aperture of the probe is in fluid communication with the interior conduit or chamber thereof to allow the passage of substance through the probe and into the interior conduit or chamber of the connector, or vice versa.

[0019] In some embodiments, the wiping and sealing member defines a normally-closed aperture extending therethrough. In the disconnected position, the normally-closed aperture defines a substantially fluid-tight seal. The normally-closed aperture is configured such that in the connected position, during movement of the wiping and sealing member and/or probe relative to the other, the probe is received into the normally-closed aperture, and the wiping and sealing member wipes the probe and maintains a substantially fluid-tight seal therebetween. In some embodiments, the normally-closed aperture extends axially through the wiping and sealing member from an exterior to an interior surface thereof. In some embodiments, the normally- closed aperture includes a normally closed slot. In some embodiments, the normally-closed aperture includes a plurality of normally-closed slots that extend radially outwardly from an approximate center point or axis of symmetry of the wiping and sealing member and are angularly spaced relative to each other. In some such embodiments, the normally-closed slots extend axially from an exterior to an interior surface of the wiping and sealing member. In some such embodiments, the normally-closed aperture includes three slots approximately equally spaced relative to each other. [0020] In some embodiments, the wiping and sealing member is formed of one or more elastomeric materials, and is radially compressed and/or displaced within the connector to close the normally-closed aperture and form the substantially fluid-tight seal. Some such embodiments further comprise a support that extends about a periphery of the wiping and sealing member that compresses and/or displaces the wiping and sealing member radially inwardly to close the normally-closed aperture and form the substantially fluid-tight seal. In some such embodiments, the support includes a plurality of compressive sections that are angularly spaced relative to each other and extend radially inwardly in engagement with the wiping and sealing member to close the normally-closed aperture and form the substantially fluid-tight seal. In some such embodiments, each compressive section defines an approximate arcuate shape. In some embodiments, the normally-closed aperture includes a normally closed slot. In some embodiments, the normally-closed aperture includes a plurality of normally-closed slots that extend radially outwardly from an approximate center point or axis of symmetry of the wiping and sealing member. Each compressive section extends angularly between respective angularly spaced slots.

[0021] In accordance with another aspect, a method comprises the following steps: (i) moving first and second connectors from disengaged to engaged positions; (ii) wiping a probe of the first connector with a first wiping and sealing member of the first connector, wherein a substantially fluid-tight seal is maintained between the probe and first wiping and sealing member; (iii) penetrating a normally-closed opening of a second wiping and sealing member of the second connector with the probe of the first connector, and during such penetration, wiping the probe with the second wiping and sealing member, wherein a substantially fluid-tight seal is maintained between the probe and second wiping and sealing member during penetration thereof; and (iv) penetrating a sufficient portion of the probe through the second wiping and sealing member to place a flow aperture, e.g., an outflow aperture, of the probe in fluid communication with an interior of the second connector.

[0022] Some embodiments further comprise disconnecting the first and second connectors. The disconnecting includes (i) moving at least one of the probe or second wiping and sealing member relative to the other, and during such relative movement, maintaining a substantially fluid-tight seal between the probe and second wiping and sealing member, and wiping the probe with the second wiping and sealing member; (ii) moving at least one of the probe and first wiping and sealing member relative to the other, and during such relative movement, maintaining a substantially fluid-tight seal between the probe and first wiping and sealing member, and wiping the probe with the first wiping and sealing member; (iii) receiving the distal portion of the probe including the flow aperture within the first wiping and sealing member, and maintaining a substantially fluid-tight seal between the probe and first wiping and sealing member to seal the probe flow apertures within the first connector; and (iv) disengaging the first and second connectors.

[0023] Some embodiments further comprise allowing substance to flow from the probe of the first connector, through the flow aperture thereof and into the interior of the second connector, or vice versa. Some embodiments further comprise, during the flow of substance between the first and second connectors, sealing the substance from the ambient atmosphere within the first and second connectors. In some embodiments, the surfaces of the first and second connectors that contact the substance flowing therethrough are sealed with respect to ambient atmosphere. In some such embodiments, the surfaces of the first and second connectors that contact the substance flowing therethrough are aseptic or sterile.

[0024] Some embodiments further comprise (a) engaging the first and second connectors in fluid communication with each other; (b) disengaging the first and second connectors such that they are not in fluid communication with each other; and (c) repeating steps (a) and (b) one or more times, wherein the surfaces of the first and second connectors that contact the substance flowing therethrough are sealed with respect to ambient atmosphere and maintained aseptic or sterile throughout steps (a) and (b) and the repetition of such steps.

[0025] Some embodiments further comprise preventing further distal movement of the first wiping and sealing member or probe relative to the other when the first connector is in the disconnected position. Some embodiments further comprise upon or after movement of the first or second connector into the connected position, engaging the first wiping and sealing member with the second connector, and moving the first wiping and sealing member and/or probe between the first and second positions. Some embodiments further comprise upon or after movement of the first or second connector into the connected position, forming a substantially fluid-tight seal between the first and second wiping and sealing members. Some embodiments further comprise forming a substantially fluid-tight seal between distal sealing surfaces of the first and second wiping and sealing members. Some such embodiments further comprise allowing or directing fluid between or at the interface of the distal sealing surfaces to flow radially outwardly during movement of the first and/or second connectors into the connected position or in the connected position and, in turn, forming an annular, substantially fluid-tight seal between the distal sealing surfaces.

[0026] Some embodiments further comprise penetrating the probe through the slot or angularly- spaced, normally-closed slots of the normally-closed aperture and maintaining a substantially fluid-tight seal therebetween during penetration and in the second position. Some embodiments further comprise maintaining an annular or circumferential and axially-extending fluid-tight seal between the second wiping and sealing member and probe during movement between the first and second positions and in the second position. Some embodiments further comprise maintaining the annular or circumferential and axially-extending fluid-tight seal along an axial length of the probe at least equal to an axial distance between a distal end of the probe and a location proximal to the flow aperture of the probe. Some embodiments further comprise maintaining the normally-closed opening of the second wiping and sealing member normally closed with a plurality of compressive sections that are angularly spaced relative to each other and extend radially inwardly in engagement with the second wiping and sealing member.

[0027] One advantage of the present invention, and/or of one or more embodiments disclosed herein, is that the connectors can allow for multiple connections and disconnections while maintaining the interior or critical surfaces of the connectors that contact the substance flowing therethrough, and/or the substance flowing therethrough, aseptic or sterile. Yet another advantage is that such aseptic or sterile connections and reconnections can occur in a no n- sterile environment or a bath of germs while nevertheless maintaining the critical surfaces and/or substances flowing therethrough aseptic or sterile.

[0028] Yet another advantage of at least some embodiments is that the first wiping and sealing member of the first or male connector can maintain the surfaces of the connector that contact the substances flowing therethrough sealed with respect to the ambient atmosphere and thus maintain such surfaces aseptic or sterile. Similarly, the second wiping and sealing member of the second or female connector can maintain the surfaces of the connector that contact the substances flowing therethrough sealed with respect to the ambient atmosphere and thus maintain such surfaces aseptic or sterile. Yet another advantage is that when the first and second connectors are in the connected position, the first and second wiping and sealing members engage each other and form a substantially fluid-tight seal therebetween. As a result, the surfaces of the connector assembly that contact the substances flowing therethrough are sealed with respect to the ambient atmosphere and thus such surfaces can be maintained aseptic or sterile.

[0029] Yet another advantage of at least some embodiments is that the probe and/or first wiping and sealing member of the first connector cannot be moved from the first position to the second position until the connectors are moved into an engaged or connected position. Then, when in the engaged or connected position, upon moving the probe and/or first wiping and sealing member from the first position to the second position, the probe passes through the sealed interface of the distal sealing surfaces of the first and second wiping and sealing members, and penetrates through the normally-closed aperture of the second wiping and sealing member. Then, in the second position, the flow aperture of the probe is placed in fluid communication with the interior of the second connector.

[0030] Another advantage of at least some embodiments is that during movement between the first and second positions, the probe is initially wiped by the first wiping and sealing member, and then after passage through the sealed interface of the first and second distal sealing surfaces, is wiped by the second wiping and sealing member. The wiping action of the first and second wiping and sealing members decontaminates the surfaces of the probe by physical interaction, and thus can maintain or render the probe surfaces aseptic or sterile or substantially or sufficiently aseptic or sterile during connection or interconnection of the first and second connectors, and, consequently, during subsequent fluid flow between the connectors. It should be understood that such decontamination can be of biological and/or non-biological contaminants. Decontamination may occur, for example, by removal of contaminants from the probe surfaces, e.g., by friction. Decontamination may also occur by physical damage to or destruction of the contaminants from the physical interaction between the probe surfaces and the first and second wiping and sealing members. For example, forces asserted on contaminants by a wiping and sealing member, e.g., pressure, can physically damage or destroy them, such as, but not limited to, by crushing or tearing. Those of ordinary skill in the art should appreciate that the foregoing are exemplary decontamination mechanisms, and that other decontamination mechanisms that currently exist or are later developed are within the scope of this disclosure. Those skilled in the art should also appreciate that decontamination can occur by a combination of multiple decontamination mechanisms, with different degrees of contribution among the different mechanisms. The mechanisms, and degrees of contribution, may also vary at different locations of the wiping and sealing members, and/or at different times during relative movement of the probe and a wiping and sealing member. The following include disclosure of wiping and/or decontamination and are incorporated by reference as if fully set forth herein: U.S. Patent Application No. 15/961,613, filed April 24, 2018, entitled "Self Closing Connector," which is a divisional of U.S. Patent Application No. 13/864,919, filed April 17, 2013, now U.S. Patent No. 9,951,899, which, in turn, claims the benefit of similarly-titled U.S. Provisional Patent Application No. 61/784,764, filed March 14, 2013, similarly-titled U.S. Provisional Patent Application No. 61/635,258, filed April 18, 2012, and similarly-titled U.S. Provisional Patent Application No. 61/625,663, filed April 17, 2012; U.S. Patent Application No. 14/536,566, filed November 7, 2014, entitled "Device for Connecting or Filling and Method," which is a continuation-in-part of similarly-titled U.S. Patent Application No. 13/874,839, filed May 1,

2013, now U.S. Patent No. 9,989,177, which, in turn, claims the benefit of similarly-titled U.S. Provisional Patent Application No. 61/794,255, filed March 15, 2013, and similarly-titled U.S. Provisional Patent Application No. 61/641,248, filed May 1, 2012; U.S. Patent Application No. 16/000,172, filed June 5, 2018, entitled "Device for Connecting or Filling and Method," which is a continuation of U.S. Patent Application No. 13/874,839, filed May 1, 2013, now U.S. Patent No. 9,989,177, which, in turn, claims the benefit of similarly-titled U.S. Provisional Patent Application No. 61/794,255, filed March 15, 2013, and similarly-titled U.S. Provisional Patent Application No. 61/641,248, filed May 1, 2012; U.S. Patent Application No. 15/434,468, filed February 16, 2017, entitled "Controlled Non-Classified Filling Device and Method," which is a divisional application of similarly-titled U.S. Patent Application No. 14/214,890, filed March 15,

2014, now U.S. Patent No. 9,604,740, which, in turn, claims the benefit of similarly-titled U.S. Provisional Patent Application No. 61/798,210, filed March 15, 2013; U.S. Patent Application No. 15/944,094, filed April 3, 2018, entitled "Septum That Decontaminates by Interaction With Penetrating Element," which is a continuation of similarly-titled U.S. Patent Application No. 15/267,131, filed September 15, 2016, now U.S. Patent No. 9,931,274, which claims the benefit of similarly-titled U.S. Provisional Patent Application No. 62/219,035, September 15, 2015; and U.S. Patent Application No. 13/917,562, filed June 13, 2013, entitled "Device With Penetrable Septum, Filling Needle and Penetrable Closure, and Related Method," which claims the benefit of similarly-titled U.S. Provisional Patent Application No. 61/799,744, filed March 15, 2013, and similarly-titled U.S. Provisional Patent Application No. 61/659,382, filed June 13, 2012.

[0031] Those skilled in the art should also appreciate that the first and second connectors can be configured to provide a desired level of decontamination. As non-limiting examples, one or more of the material, frictional characteristics, compressibility and/or elasticity of the first and/or second wiping and sealing members, and/or the diameter/configurations of the apertures therein, can be selected to provide a desired level of decontamination. In some embodiments, for example, the wiping provides a 3-log reduction (10 " or 99.9%) in contaminants. Other embodiments provide a 6-log reduction (10 "6 ). Yet other embodiments provide an 8-log reduction.

[0032] Then, when the connectors are disconnected, the probe is moved from the second position back to the first position, the probe surfaces are decontaminated again, initially by the wiping action of the second wiping and sealing member, and then upon passage through the sealed interface of the distal sealing surfaces, by the wiping action of the first wiping and sealing member. Yet another advantage is that the wiping of the probe during movement from the second position to the first position decontaminates the surfaces of the probe by physical interaction, and thus can further maintain such surfaces aseptic or sterile and sealed with respect to the ambient atmosphere.

[0033] Yet another advantage is that in the first position, the probe is received within, and its flow aperture(s) is/are sealed within, the first wiping and sealing member. A further advantage of at least some embodiments is that the connectors can be disconnected only when the first wiping and sealing member and probe are in the first position in order to prevent any exposure of the normally- sealed, or aseptic or sterile surfaces of the probe, to the ambient atmosphere.

[0034] Yet another advantage is that in at least some embodiments the resilient or elastomeric wiping and sealing members sealingly engage the surfaces of the probe forming an annularly- extending or circumferentially-extending and axially-extending fluid-tight seal therebetween. The axial length of the seal, the annular or circumferential interference between the wiping and sealing members and the probe, and/or the radial compression of the wiping and sealing members against the probe, ensure sufficient physical interaction of the probe and wiping and sealing members during their relative movement to decontaminate, and to maintain or render the probe surfaces aseptic or sterile. Yet another advantage is that the intimate engagement of the probe and wiping and sealing members, and relative movement therebetween during movement between the first and second positions, can wipe the surfaces with sufficient physical interaction to decontaminate the surfaces of the probe during such movement and thereby maintain or render such surfaces aseptic or sterile during repeated connections and disconnections of the connector assembly.

[0035] Other advantages will become more readily apparent in view of the following detailed description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0036] FIG. 1A is a cross-sectional view of a first or male connector prior to or during assembly of the first wiping and sealing member to the first body;

[0037] FIG. IB is a cross-sectional view of the first or male connector of FIG. 1A where the first wiping and sealing member is assembled to the first body and is located in the first position sealing the distal end of the probe and probe apertures, and thus the interior conduit of the probe, with respect to the ambient atmosphere;

[0038] FIG. 2A illustrates on the left a cross-sectional view of the second or female connector and illustrates on the right a cross-sectional view of the second wiping and sealing member prior to assembly to the second body of the female connector, where the normally-closed aperture of the second wiping and sealing member is open prior to insertion into the second body of the female connector, as shown on the right, and then, upon insertion into the second body, as shown on the left, the second wiping and sealing member is compressed to close the aperture into its normally-closed, fluid-tight condition;

[0039] FIG. 2B illustrates on the left a cross-sectional view of the female connector in the left of FIG. 2A along section A-A, and illustrates on the right a cross-sectional view of the preassembled second wiping and sealing member in the right of FIG. 2A along section B-B;

[0040] FIG. 3A is a cross-sectional view of a connector assembly where the connectors are engaged but not fully connected, and illustrating on the left the female connector of FIG. 2A, and on the right the male connector of FIG. IB;

[0041] FIG. 3B illustrates on the left a cross-sectional view of the connector assembly of FIG. 3A along section C-C and on the right a cross-sectional view of the male connector of FIG. 3A along section D-D; [0042] FIG. 4 is a cross-sectional view of the connector assembly of FIG. 3A where the female and male connectors are pressed into further engagement with each other forming a fluid- tight seal at the interface of the distal sealing surfaces of the first and second wiping and sealing members, to thereby further seal the interiors of both connectors and allow the probe to pass through the interface without exposure to the ambient atmosphere, and during which the distal end of the probe is both sealed and wiped by first wiping and sealing member;

[0043] FIG. 5A is a cross-sectional view of the connector assembly of FIG. 4 where the female connector is moved further together with the male connector in the direction from the first position to the second position, during which the distal portion of the probe is sealed and wiped by both the first and second wiping and sealing members;

[0044] FIG. 5B is a cross-sectional view of the connector assembly of FIG. 5A along section E-E illustrating receipt of the probe into the normally-closed aperture of the second wiping and sealing member, and the radial flexing of the arcuate compressive sections that facilitate maintaining the second wiping and sealing member in fluid-tight engagement with the probe during passage through its aperture;

[0045] FIG. 6A is a cross-sectional view of the connector assembly of FIG. 5A illustrating the connectors in the second position where the distal end of the probe, including its flow apertures, is received within the sealed interior of the female connector to allow the flow of fluid or other substance, including an aseptic or sterile flow, between the male and female connectors;

[0046] FIG. 6B is a cross-sectional view of the connector assembly of FIG. 6A along section F-F illustrating its condition in the second position;

[0047] FIG. 7A is a cross-sectional view of the connector assembly of FIG. 6A where the first and second wiping and sealing members are initially moved back in the direction from the second position to the first position, and where distal end portion of the probe is sealed and wiped by both the first and second wiping and sealing members;

[0048] FIG. 7B is a cross-sectional view of the connector assembly of FIG. 7A along section G-G;

[0049] FIG. 8A is a cross-sectional view of the connector assembly of FIG. 7A where the female and male connectors are engaged, and the probe and first and second wiping and sealing members are in the first position such that the apertures of the probe are sealed within the first wiping and sealing member and the aperture of the second wiping and sealing member is in its normally-closed, fluid-tight condition;

[0050] FIG. 8B illustrates on the left a cross-sectional view of the connector assembly of FIG. 8A along section H-H and on the right a cross-sectional view of the male connector of FIG. 8A along section I-I;

[0051] FIG. 9A is a cross-sectional view of the connector assembly of FIG. 8A illustrating the male and female connectors in the disengaged and fully disconnected position;

[0052] FIG. 9B illustrates on the left a cross-sectional view of the female connector of FIG. 9A along section J-J and on the right a cross-sectional view of the male connector of FIG. 9A along section K-K;

[0053] FIG. 10 is an exploded, cross-sectional view of the male connector of FIGS. 1A and IB prior to assembly of the first wiping and sealing member and spring within the first body;

[0054] FIG. 11A is an exploded, cross-sectional view of the female connector of FIGS. 2A and 2B prior to assembly of the second wiping and sealing member into the second body; and

[0055] FIG. 1 IB is a cross-sectional view of the second wiping and sealing member of FIG. 11 A along section L-L.

[0056] FIGS. 12A-12C illustrate an embodiment in which the apertures of the first and second wiping and sealing members have a different configuration than in FIGS. 1-1 IB.

DETAILED DESCRIPTION OF EMBODIMENTS

[0057] In FIGS. 1 through 11, a connector assembly is indicated generally by the reference numeral 10. The connector assembly 10 comprises a first or male connector 12 and a second or female connector 14. The first connector 12 includes a probe 16 defining a plurality of flow apertures 18, 18 (though other embedment may have only one flow aperture) in fluid communication with an interior passageway or conduit 20 of the probe 16, and a first wiping and sealing member 22 that engages the probe 16 and forms a substantially fluid-tight seal along an annular or circumferential and axially- extending interface 24 therebetween. In the illustrated embodiment, the tip of the probe 16, e.g., distal of the aperture 18, has a flattened configuration or profile. Those of ordinary skill in the art should understand, though, that the probe 16 may have any suitable configuration or profile, e.g., round, oval, etc. [0058] The probe 16 and/or first wiping and sealing member 22 is movable between a first position, shown, for example, in FIGS. IB and 3B, and a second position, shown exemplarily in FIG. 6A. During movement between the first and second positions, the first wiping and sealing member 22 wipes the probe and maintains a substantially fluid-tight seal at the interface 24 therebetween.

[0059] The second connector 14 includes a second wiping and sealing member 26. The first and/or second connectors 12, 14 are movable between a disconnected position (e.g., FIG. 9A) where they are disconnected, and an engaged or connected position where they are engaged or connected (e.g., FIG. 6A). When connected, (i) during movement of the first wiping and sealing member 22 and/or probe 16 between the first and second positions, shown exemplarily at FIGS. 4 through 6A, the probe moves through the second wiping and sealing member 26, and the second wiping and sealing member 26 engages the probe 16, forms a substantially fluid-tight seal along an annular or circumferential and axially-extending interface 28 therebetween, and wipes the probe 16, and (ii) in the second position, shown exemplarily in FIG. 6A, the apertures 18, 18 of the probe are in fluid communication with an interior 30 of the second connector 14 to thereby allow the passage of substance from the first connector 12, through the probe 16, and into the interior 30 of the second connector 14, or vice versa.

[0060] As shown exemplarily in FIG. 3A, the first wiping and sealing member 22 extends about the probe, and forms an annular or circumferential, axially-extending, substantially fluid- tight seal 24 therebetween. In the first position, shown exemplarily in FIG. 3A, the first wiping and sealing member 22 extends axially from a first location 32 at approximately or towards the distal end of the probe 16 to a second location 34 proximal the flow apertures 18, 18. The interface 24 defining the substantially fluid-tight seal extends annularly or circumferentially about the probe 16, and may extend axially from the first location 32 to the second location 34. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the axial length of the interface 24 may be longer or shorter than shown and described, while nevertheless performing its requisite functions, such as forming a fluid-tight seal and wiping the probe.

[0061] The first wiping and sealing member 22 defines an aperture 25 that extends axially therethrough. The aperture 25 defines an inner diameter, width or other dimension that is less than the outer diameter or width of the probe 16 to thereby form an interference fit therebetween, which term ("interference fit")_should readily be understood by those of ordinary skill in the art. The first wiping and sealing member 22 is formed of a resilient and/or elastomeric material, such as a thermoplastic elastomer, silicone and/or other polymeric materials or combinations thereof. Accordingly, when the probe 16 is located within the aperture 25, e.g., as shown FIG. 1, the material of the first wiping and sealing member 22 moves, deforms, or compresses (e.g., outwardly) to accommodate the larger dimension(s) of the probe 16. The interference fit is sufficient to create or contributes to creating frictional forces and/or stretching at the interface 24 to decontaminate the surfaces of the probe 16 by physical interaction therewith during movement between the first and second positions. As shown exemplarily in FIG. 1A, each aperture 18 defines a peripheral edge 27, which may be, in some embodiments, chamfered or oriented at an angle that slopes downwardly and inwardly into the aperture at an acute angle with respect to an axis of symmetry of the probe. One advantage of this configuration is that during relative movement of the probe and first and second wiping and sealing members, the beveled surface slidably contacts each wiping and sealing member but does not cut or tear the wiping and sealing members. The inner edge of each such peripheral edge surface is spaced sufficiently below the exterior surface of the probe 16 and/or is oriented at an inwardly sloping angle that is sufficient to prevent such edge from engaging and cutting or tearing either wiping and sealing member during movement between the first and second positions.

[0062] The first connector 12 further includes a spring 36 that normally biases the first wiping and sealing member 22 toward the first position. In the illustrated embodiment, the spring is a coil spring. The first connector 12 further includes a first body 38 defining a hollow interior that receives therein the first wiping and sealing member 22. The probe 16 extends from a base 40 at the proximal end of the body to a location spaced within and adjacent to a distal end 42 of the body. The spring 36 is seated between the base 40 of the body and the proximal end of the first wiping and sealing member 22. The first wiping and sealing member 22 includes a first support 44 extending about a periphery thereof. The first wiping and sealing member 22 defines a portion 46 for receiving/engaging the distal end of the spring 36. In some embodiments, the portion 46 of the first support 44 defines an annular recess for receiving therein the distal end of the spring 36. In the illustrated embodiment, the first support 44 and first wiping and sealing member 22 are co-molded, such as by over-molding the first wiping and sealing member to the first support 44. However, as may be recognized by those of ordinary skill in the pertinent art, these parts or the combined parts can be made in any of numerous different ways in accordance with any of numerous different configurations that are currently known, or that later become known. The proximal end of the first support 44 includes a radially-extending catch 48. The body 38 includes a stop 50. As shown in FIG. IB, the stop 50 engages the catch 48 of the first wiping and sealing member 22 in the first position, and prevents further distal movement of the first wiping and sealing member 22 relative to the probe 16 when the first connector is in the disconnected position. Accordingly, the spring 36 normally biases the first wiping and sealing member 22 into the first position where the catch 48 is biased into engagement with the stop 50 and the flow apertures 18, 18 of the probe are sealed within the first wiping and sealing member. As shown in FIGS. 4 through 6A, movement of the first wiping and sealing member 22 and/or probe 16 in the direction from the first position toward the second position is against the bias or force of the spring 36. Although a coil spring is illustrated, the spring may take the form of any of numerous different springs or other types of biasing member that are currently known, or that later become known, including, for example, a coil or other type of spring that is co-molded with the body 38 and/or first support 44. As described further below, the first wiping and sealing member 22 is engageable by the second connector 14, and is movable between the first and second positions upon or after movement of the second connector into the connected position.

[0063] As shown in FIGS. 4 through 7 A, during movement toward and in the connected position, the first and second wiping and sealing members 22 and 26, respectively, form a substantially fluid-tight seal therebetween. As shown in FIG. 1A, the first wiping and sealing member 22 defines a first distal sealing surface 54, and as shown in FIG. 2A, the second wiping and sealing member 26 defines a second distal sealing surface 56. As shown exemplarily in FIGS. 3 A and 4, in the connected or engaged position, the first and second distal sealing surfaces 54 and 56, respectively, form a substantially fluid-tight seal at an annular, substantially radially- extending interface 52 therebetween. As shown in FIG. IB, the first distal sealing surface 54 defines a first angle 58 with respect to an axis of symmetry 60 of the connector assembly. As shown in FIG. 2A, the second distal sealing surface 56 defines a second angle 62 with respect to the axis 60. In the illustrated embodiment, the second angle 62 is greater than the first angle 58 in order to direct fluid at the interface 52 of the first and second distal sealing surfaces radially outwardly during movement of the first and second connectors from the disconnected position into the connected position or in the connected position. Accordingly, any fluid that contacts the first or second distal sealing surfaces 54, 56, which, prior to connection of the connectors 12, 14 may be exposed to ambient atmosphere or the environment and thus may be contaminated, and thus may contaminate fluid contacting those surfaces 54, 56, does not flow into the other (downstream) connector. In the illustrated embodiment, the angle differential need only be enough to achieve this function. In one embodiment, the angle differential is less than about 20°, and can be less than about 10°, or within the range of about 3° to about 8°. However, as may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, these first, second angle differentials are only exemplary, and other differential values may be employed. In addition, the second angle could be less than the first angle, and the angles could employ the same or different angle differentials.

[0064] As shown in FIG. 2A, the second wiping and sealing member 26 defines a normally- closed aperture 64 extending therethrough. In the disconnected position, the normally-closed aperture 64 defines a substantially fluid-tight seal. In the connected position, as shown exemplarily in FIGS. 4 through 6A, during movement of the second wiping and sealing member 26 and/or probe 16 relative to the other, the probe 16 is received into the normally-closed aperture 64, and the second wiping and sealing member 26 wipes the probe and maintains a substantially fluid-tight seal at an annular or circumferential and axially-extending interface 28 therebetween. In the illustrated embodiment, the normally-closed aperture 64 extends axially through the second wiping and sealing member 26 from the exterior or second distal sealing surface 56 to an interior surface 68 thereof. As shown exemplarily in FIGS. 2B and 3B, in the illustrated embodiment, the normally-closed aperture 64 includes a slot. The normally-closed slot 70 extends axially from the exterior surface 56 to the interior surface 68 thereof. Like the normally-closed aperture 64, the slot 70 is normally closed and forms a substantially fluid-tight seal in the normally-closed condition. Also like the normally-closed aperture 64, the normally- closed slot 70 extends axially from the exterior surface 56 to the interior surface 68 of the second wiping and sealing member 26. In the illustrated embodiment, the normally-closed aperture defines a length approximately equal to or greater than the distance between the first location 32 at the distal end of the probe and the location 34 proximal to the probe apertures 18, 18 (FIG. 3 A).

[0065] As shown on the right in FIG. 3B, the first wiping and sealing member 22 may similarly define a slot 70' defined by the aperture 25 thereof. The slot 70' may take the same or substantially the same configuration as the slot 70 of the second wiping and sealing member 26 described above in order to facilitate passage of the probe 16 through the first wiping and sealing member 22 while nevertheless maintaining a fluid-tight seal between probe and first wiping and sealing member 22 and decontaminating the probe 16 by physical interaction therewith. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the apertures and/or slots of the first and second wiping and sealing members may take any of numerous different configurations or shapes that are currently known, or that later become known. In addition, the apertures for the first and second wiping and sealing members may include a plurality of slots.

[0066] Like the first wiping and sealing member 22, the second wiping and sealing member 26 is formed of one or more elastomeric or resilient materials. The elastomeric or resilient materials may take the form of any of numerous different thermoplastic elastomers, silicones, other plastics, rubbers, or combinations thereof, that are currently known, or that later become known. The second wiping and sealing member 26 includes a second support 72 extending about a periphery of the second wiping and sealing member, and an elastomeric body 26 received within the second support and defining the normally-closed aperture 64. In illustrated embodiment, the second support and elastomeric body are co-molded to each other, such as by over-molding the elastomeric body to the second support.

[0067] As shown exemplarily in FIGS. 2B and 3B, the second elastomeric wiping and sealing member 26 is radially compressed and/or displaced within the second connector 14 to close the normally-closed aperture 64 and slot 70 and form the substantially fluid-tight seals. The second connector 14 includes a second body 74 that extends about a periphery of the second wiping and sealing member 26 and compresses and/or displaces the second wiping and sealing member 26 radially inwardly to close the normally-closed aperture/slot 64, 70 and form the substantially fluid-tight seals. The second body 74 includes a plurality of compressive sections 76, 76 that are angularly spaced relative to each other along the interior wall of the second body 74 and extend radially inwardly in engagement with the second wiping and sealing member 26 to press the second wiping and sealing member 26 radially inwardly and close the normally-closed aperture/slot 64, 70 and form the substantially fluid-tight seals. In the illustrated embodiment, each compressive section 76, 76 defines an approximate arcuate shape that extends angularly about the slot 70 and extends axially from the proximal base of the second body 74 to a location adjacent to, and spaced within the distal end of the second body. In the illustrated embodiment, the compressive sections 76, 76 are made of a flexible material; however, the compressive section material is generally less flexible than the elastomeric or resilient material of the second wiping and sealing member 26 in order to allow the compressive sections to press the second wiping and sealing member 26 radially inwardly and form the normally-closed aperture/slot 64, 70 and substantially fluid-tight seals.

[0068] As shown in FIGS. 2A and 3 A, the second body 74 receives the second wiping and sealing member 26 and its second support 72 such that the compressive sections 76, 76 are pressed between the second body 74 and the elastomeric or resilient second wiping and sealing member 26 to form the normally-closed aperture/slot 64, 70 and fluid-tight seals. As shown in FIGS. 5A through 7A, in the connected position, during movement of the first wiping and sealing member 22 and/or probe 16 between the first and second positions, the probe 16 moves through the second wiping and sealing member 26, and the second wiping and sealing member 26 engages the probe 16, forms a substantially fluid-tight seal therebetween, and wipes the probe 16. Similarly to the aperture 25 of the first wiping and sealing member 22, the aperture 64 defines at least one dimension that is less than a dimension of the probe 16 to form an interference fit therewith. Accordingly, when the probe 16 is located within the aperture 65, e.g., as shown FIGS. 5 A, 6A and 7 A, the material of the first wiping and sealing member 22 moves, deforms, or compresses (e.g., outwardly) to accommodate the larger dimension(s) of the probe 16. Similar to the with the first wiping and sealing member 22, the interference fit creates or contributes to decontamination of the surfaces of the probe 16. One of ordinary skill in the art should understand, though, that the interference fit formed with probe 16 with the first wiping and sealing member 22 may be different than, including (but not limited to) in degree and/or location, than that formed with the second wiping and sealing member 26.

[0069] The second body 74 and compressive sections 76, 76 cooperate with the second wiping and sealing member 26 to seal the interior 30 of the second connector with respect to the ambient atmosphere. The second body 74 further includes a conduit 78 in fluid communication with the interior 30. As shown in FIG. 6A, in the second or fully-connected position, the apertures 18, 18 of the probe 16 are in fluid communication with the interior 30 of the second connector 14 to thereby allow the passage of substance from the conduit 20 of the probe 16 of the first connector 12 into the interior 30 and conduit 78 of the second connector 14, or vice versa. As shown in FIG. 3B, the first body 38 includes on its interior surface for receiving thereon the second support a plurality of ribs 90, 90 that are angularly spaced relative to each other. The second support 72 defines on its exterior surface a plurality of corresponding recesses or grooves 90, 90. As can be seen, the ribs 90, 90 are received within the corresponding grooves 90, 90 to fix the relative angular positions of the first body 38 and the second support 72. Accordingly, the first connector 12 and the second connector 14 can be connected only in predetermined angular relationship to each other.

[0070] In the operation of the connector assembly 10, the first and second connectors 12 and 14, respectively, may be connected in accordance with the following steps: (i) Moving the first and second connectors 12 and 14, respectively, from disengaged to engaged positions; (ii) In the engaged position, and as shown in FIG. 3B and 4, moving the second connector 14 into the first connector 12 to, in turn, move the first wiping and sealing member 22 against the bias of the spring 36 from the first position toward the second position; this, in turn, causes the first wiping and sealing member 22 to wipe the probe 16 while maintaining a substantially fluid-tight seal between the probe 16 and first wiping and sealing member 22; (iii) As shown in FIGS. 4 through 6B, further moving the second connector 14 and the first connector 12 together to press the first and second distal sealing surfaces 54 and 56, respectively, into sealed engagement with each other, and cause the probe 16 to penetrate the normally-closed aperture 64 and slot 70 of the second wiping and sealing member 26 of the second connector 14; (iv) As shown in FIGS. 5A and 6 A, during such penetration, wiping the probe 16 with the second wiping and sealing member 26 and maintaining a substantially fluid-tight seal between the probe 16 and second wiping and sealing member 26 during penetration thereof; as shown exemplarily in FIG. 5B, the probe 16 expands the normally-closed aperture 64 and slot 70 radially outwardly while maintaining the second wiping and sealing member 26 in sealed, frictional engagement with the probe 16 to maintain a fluid-tight seal and decontaminate the probe 16 by physical interaction therewith during wiping; (iv) As shown in FIG. 6A, penetrating a sufficient portion of the probe 16 through the second wiping and sealing member 26 to place the flow apertures 18, 18 of the probe in fluid communication with the interior 30 of the second connector 14; and (v) Allowing the passage of substance from the conduit 20 of the probe 16 of the first connector 12 into the interior 30 and conduit 78 of the second connector 14, or vice versa. [0071] The first and second connectors 12 and 14, respectively, may be disconnected in accordance with the following steps: (i) As shown in FIG. 7A, moving at least one of the probe 16 or second wiping and sealing member 26 relative to the other, during such relative movement, maintaining a substantially fluid-tight seal between the probe 16 and second wiping and sealing member 26, and wiping the probe 16 with the second wiping and sealing member 26; (ii) As shown in FIGS. 7 A and 8 A, moving at least one of the probe 16 and first wiping and sealing member 22 relative to the other, during such relative movement, maintaining a substantially fluid-tight seal between the probe 16 and first wiping and sealing member 22, and wiping the probe 16 with the first wiping and sealing member 22; (iii) As shown in FIGS. 8 A and 9 A, receiving the apertures 18, 18 of the probe 16 within the first wiping and sealing member 22, and maintaining a substantially fluid-tight seal between the probe 16 and first wiping and sealing member 22 to seal apertures 18, 18 of the probe within the first or male connector 12; and (iv) As shown in FIG. 9A, disengaging the first and second connectors 12, 14.

[0072] In the illustrated embodiment, the interior or others surfaces of the first and second connectors 12, 14 that can contact the substance flowing therethrough are sealed with respect to the ambient atmosphere throughout the connecting and disconnecting processes. In addition, during relative movement of the probe and first and second wiping and sealing members between the first and second positions, the probe is wiped by the first and second wiping and sealing members, and the resulting physical interaction between the probe and wiping and sealing members decontaminates the probe. As a result, the above-mentioned interior or other surfaces of the first and second connectors can be aseptic or sterile (or sufficiently so), and thus can maintain an aseptic or sterile substance flowing therethrough in such condition. Further, the connectors can maintain such aseptic or sterile condition after repeated connections and disconnections.

[0073] FIGS. 12A-12C illustrate an embodiment in which the apertures of the first and second wiping and sealing members have a different configuration than in FIGS. 1-1 IB. The wiping and sealing members are similar to first and second wiping and sealing members 22, 26 described above, and therefore like reference numerals preceded by the numeral "1" instead are used to indicate like elements. In this embodiment, the normally-closed aperture 164 of the second wiping and sealing member 126 includes, as shown exemplarily in FIGS. 12A and 12B, a plurality of normally-closed slots 170 that extend radially outwardly from the aperture 164 and thus from an approximate center point or axis of symmetry of the second wiping and sealing member 126. The normally-closed slots 70, 70 are angularly spaced relative to each other, and extend axially from the exterior surface to the interior surface of the second wiping and sealing member 126. The illustrated embodiment includes three normally-closed slots 170, 170 that are approximately equally angularly spaced relative to each other, i.e., they are spaced about 120° relative to each other. Also, each angularly-extending slot can extend radially a distance at least equal to the radius of the probe 116, and in the illustrated embodiment, a distance greater than the radius of the probe 116. Like the normally-closed aperture 164, the slots 170, 170 that extend radially outwardly therefrom also are normally closed and form a substantially fluid-tight seal in the normally-closed condition. The normally-closed aperture 164 can define a length approximately equal to or greater than the distance between the distal end of the probe 116 and proximally to the probe apertures.

[0074] FIG. 12A shows the second wiping and sealing member prior to installation with the second body 174. As can be seen, the normally-closed aperture 164 and slots 170 are in an open condition.

[0075] FIG. 12B shows the second wiping and sealing member after installation with the second body. As can be seen, the second body 174 includes a plurality of compressive sections 176, 176, 176 that are angularly spaced relative to each other along the interior wall of the second body 174 and extend radially inwardly in engagement with the second wiping and sealing member 126 to press the second wiping and sealing member 126 radially inwardly and close the normally-closed aperture/slots 164, 170 and form substantially fluid-tight seals. In the illustrated embodiment, each compressive section 76, 76 defines an approximate arcuate shape that extends angularly about the second wiping and sealing member 126. In the illustrated embodiment, the compressive sections 176, 176 are made of a flexible material; however, the compressive section material is generally less flexible than the elastomeric or resilient material of the second wiping and sealing member 126 in order to allow the compressive sections to press the second wiping and sealing member 126 radially inwardly and form the normally-closed aperture/slot 164, 170 and substantially fluid-tight seals. The illustrated embodiment includes three compressive sections 176 that are equally angularly spaced around the second wiping and sealing member 126, i.e., at 120° to each other. The equal angular spacing provides symmetric compressive force on the second wiping and filling member 126. [0076] As shown in FIG. 12C, the first wiping and sealing member 122 may similarly define a plurality of slots 170', 170' extending radially from the aperture 125 thereof, and angularly spaced relative to each other. The slots 170', 170' may take the same or substantially the same configuration as the slots 170, 170 of the second wiping and sealing member 126 described above in order to facilitate passage of the probe 116 through the first wiping and sealing member 122 while nevertheless maintaining a fluid-tight seal between probe 116 and first wiping and sealing member 122 and decontaminating the probe 116 by physical interaction therewith.

[0077] However, in other embodiments, the aperture 125 may have a different configuration, such as the configuration of aperture 25 shown in FIGS. 1-1 IB and described above, or any suitable configuration. That is, for example, the aperture 125 of the first wiping and sealing member 122 may have a different configuration than the aperture 164 of the second wiping and sealing member 122. Thus, as should be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the apertures and/or slots of the first and second wiping and sealing members may take any of numerous different configurations or shapes that are currently known, or that later become known.

[0078] The term "probe" is used herein to mean a hollow, slender device with one or more apertures extending through a wall of the probe to allow the flow of fluids or other substances therethrough, such as from the interior of the probe to the exterior of the probe. The term "needle" is used herein to mean a type of probe defining a sharp point at one end to facilitate piercing an object, such as for piercing through a wiping and/or sealing member. The illustrated embodiments use probes; however, needles in lieu of probes equally may be employed. The probes and needles may take any of numerous different configurations, and may be made of any of numerous different materials, such as any of numerous different metals, plastics or combinations thereof, that are currently known, or that later become known. The term "seal" herein can include, but is not limited to, a hermetic seal or a seal from the ambient atmosphere or environment.

[0079] As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, numerous changes or modifications may be made to the above-described and other embodiments without departing from the scope of the present invention. For example, the connectors and the components thereof can be made of any of numerous different materials or combinations thereof, in accordance with any of numerous different methods, that are currently known or that later become known. In addition, the connectors and components thereof can be made in any of numerous different shapes or configurations that are currently known, or that later become known. The connectors or connector assemblies may be employed for aseptic or sterile transfer of fluids or other substances, or may be employed to transfer fluids or other substances that are not aseptic or sterile. Further, the first or male connectors may be used without the second or female connectors to, for example, aseptic or sterile fill a device by penetrating a septum of the device with the probe or needle, and aseptic or sterile filling the device therethrough. Accordingly, this detailed description of embodiments is to be taken in an illustrative as opposed to a limiting sense.