Luer receiver and method for fluid transfer

• US 6,171,287 B1
• Filed: 05/28/1999
• Issued: 01/09/2001
• Est. Priority Date: 05/29/1998
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co, Lawrence A. Lynn
• Original Assignee: Becton, Dickinson & Co, Lawrence A. Lynn
• Inventors: Purdy, Edmund Robert, Harding, Weston, Lynn, Lawrence A.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Rodriguez, Chris L.
• Application Number:
  US09/322,037
• Time in Patent Office: 592 Days
• Field of Search: 604/533, 604/236, 604/237, 604/238, 604/244, 604/246, 604/256, 604/536, 604/535, 604/284, 604/537, 604/905, 251/149
• US Class Current: 604/256
• CPC Class Codes: A61M 2039/0036 characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer
• CPC Class Codes: A61M 2039/0054 Multiple layers
• CPC Class Codes: A61M 2039/0072 Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
• CPC Class Codes: A61M 2039/263 where the fluid space within the valve is decreasing upon disconnection
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/162 with antiseptic agent incorporated within the connector
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

An improved luer lock receiving septum having a configuration which provides rapid and tight resealing and yet allows penetration of the septum by the luer tip with a low penetration force. The elongated septum includes an upper portion of enlarged diameter having a target surface, a central slit, and a central, lower septum extension projecting about the slit below the upper portion and into a housing so that following luer insertion there is provided sufficient room for both the laterally displaced extension of the septum, the luer taper, and the housing to be received into a conventional luer lock connector. The septum is further preferably configured to minimize or eliminate the negative pressure deflection normally associated with the withdrawal of the large diameter luer cannula from an enclosed fluid filled lumen or chamber, by substantially isolating the lumen or chamber from the septum material displacement resultant from luer insertion.

Claims

1. A luer receiver for receiving a male luer tip, the receiver comprising:

a housing defining an inner wall, the housing having a proximal end and a distal end and a bore extending from said proximal end towards distal end, a proximal end of said housing being sized to be received into said luer lock connector,

a septum having a longitudinal axis and mounted to said housing so as to be disposed at least partially within said bore adjacent said proximal end, said septum having an upper portion with an upper face, an extension portion projecting downwardly from said upper portion, and a slit extending from adjacent said upper face through said upper portion and at least partially through said extension portion, a force being applied by said housing to said septum adjacent said upper face thereby to seal said slit adjacent said upper face, said extension portion having a width in a direction transverse to said slit that is less than a transverse width of said upper portion, said septum and said slit therein being sized and configured to receive at least a portion of said male luer end into said septum through said face and through at least a portion of said slit, at least a portion of said septum being displaced lateral to said longitudinal axis by said luer tip when said luer tip is advanced into said septum to define a displaced septum portion; and

at least one cavity defined lateral to said septum for receiving said displaced septum portion when said luer tip is advanced into said septum.

2. The luer receiving of claim 1, wherein said sealing force comprising a distorting force induced by said housing toward said slit.

3. The luer receiving of claim 1, wherein a housing had an upper surface, said upper surface at least partially induces said sealing force.

4. The luer receiving of claim 3, wherein said septum includes an upper portion mounted above said upper surface of said housing.

5. The luer receiving of claim 1, wherein said housing and said septum are sized and configured to induce axial compression of said septum adjacent said distal end of said septum.

6. The luer receiving of claim 1, wherein said slit defines opposing slit walls, and said housing and said septum are sized and configured such that when said septum is mounted with said housing said slit walls are pressed one against the other into tight sealing opposition at a plurality of distinct regions of compression along said slit.

7. The luer receiver of claim 6, wherein said regions of compression are induced by a plurality of distinct corresponding regions of said housing.

8. The luer receiver of claim 6, wherein said septum has a proximal end and a distal end said regions of compression comprises regions respectively defined adjacent said proximal end and adjacent said distal end of said septum.

9. The luer receiver of claim 6, wherein said regions of compression comprise an upper sealing region and a lower sealing region, said upper sealing region being sealed by a lesser transverse compressive force than said lower sealing region.

10. The luer receiver of claim 1, wherein the housing is configured to displace at least a portion of the septum generally longitudinally when septum is mounted with said housing, said longitudinal displacement inducing tight sealing along at least one region of said slit.

11. A medical luer receiver, comprising:

a housing having a proximal portion, a central portion, and a distal portion, and a bore extending axially through said proximal portion and said central portion into said distal portion;

a septum formed at least in part from a first elastomeric material and having a proximal portion, an extension portion, and a central slit defined at least partially therethrough, said septum proximal portion including an upper portion having a width greater than a width of said extension portion,

a proximal end of said housing comprising a substantially continuous ring structure defining a platform, said upper portion of said septum being seated on said platform.

12. A medical luer receiver as in claim 11, wherein upper surfaces of diametrically opposed first and second portions of said ring structure are inclined from a more distal radially inner edge to a more proximal radially outer edge.

13. A medical luer receiver as in claim 11, wherein said ring structure includes diametrically opposed radially inwardly extending projections.

14. A medical luer receiver as in claim 13, wherein upper surfaces of diametrically opposed first and second portions of said ring structure are inclined from a more distal radially inner edge to a more proximal radially outer edge.

15. A medical luer receiver as in claim 14, wherein said first and second inclined portions are radially aligned with said projections.

16. A medical luer receiver as in claim 13, wherein each said projection is tapered toward a radially inner edge thereof.

17. A medical luer receiver as in claim 13, wherein said projections project in a direction transverse to a direction in which said slit extends.

18. A medical luer receiver as in claim 13, wherein said proximal portion of said septum further comprises a lower portion, said lower portion of said septum proximal portion comprising groove portions for respectively receiving said projections, and projecting radially outwardly vertically below said projections so as to provide a retention force for retaining said septum within said housing.

19. A medical luer receiver as in claim 18, wherein said distal portion of said septum is generally circular in cross-section.

20. A medical luer receiver as in claim 18, further comprising a plurality of deflection reservoir cutouts defined in an outer peripheral surface of said distal portion of said septum.

21. A medical luer receiver as in claim 18, wherein said septum further comprises first and second support ribs for engaging and supporting said lower portion of said septum.

22. A medical luer receiver as in claim 11, wherein said septum further comprises a distal portion, said distal portion having a diameter greater than a diameter of said septum extension portion.

23. A medical luer receiver as in claim 22, wherein said distal portion is disposed in said central portion of said housing, said central portion of said housing having an outer diameter greater than an outer diameter of said proximal portion of said housing.

24. A medical luer receiver as in claim 19, wherein said housing comprises first and second housing parts, said first housing part including said proximal portion and said central portion of said housing, said second housing part comprising said distal portion of said housing, and said septum further comprises first and second protrusions extending downwardly from a bottom surface of said distal portion thereof, and wherein said second housing part comprises first and second recesses for respectively receiving said first and second protrusions to laterally lock said septum with respect to said second housing part.

25. A medical luer receiver as in claim 22, wherein said distal portion of said septum is generally ring shaped in transverse cross section, having a cavity defined centrally therewithin.

26. A medical luer receiver as in claim 25, wherein said septum distal portion further comprises at least one ring seal defined about an outer periphery thereof for enhanced sealing engagement with said housing.

27. A medical luer receiver as in claim 11, wherein said extension portion is disposed in said proximal portion of said housing and has at least one reduced diameter section having a transverse diameter less than an inner diameter of said housing proximal portion.

28. A medical luer receiver as in claim 11, wherein said extension portion is disposed in said proximal portion of said housing, said extension portion including a core component and a plurality of radial flange components at vertically spaced locations along said core component.

29. A medical luer receiver as in claim 11, wherein at least first and second diametrically opposed lateral voids are defined in said proximal portion of said housing, distal of said ring structure.

30. A medical luer receiver as in claim 29, wherein said voids are defined by cut outs that extend into a wall of said proximal portion of said housing so as to define slots therein.

31. A medical luer receiver as in claim 11, wherein said extension portion includes at least one cutout portion thereby to define said width thereof that is less than said width of said upper portion.

32. A medical luer receiver as in claim 31, wherein said septum further comprises a compressible material disposed in and substantially filling said at least one cutout portion, said compressible material being substantially more compressible than a material comprising said extension portion.

33. A medical luer receiver as in claim 11, wherein said upper portion of said septum proximal portion has an outer peripheral portion of increased thickness so that an upper surface of said upper portion is generally concave.

34. A medical luer receiver as in claim 11, wherein said housing comprises first and second housing parts, said first housing part including said proximal portion and said central portion of said housing, said second housing part comprising said distal portion of said housing.

35. A medical luer receiver as in claim 34, wherein said second housing part comprises a y-site connector structure.

36. A medical luer receiver as in claim 34, wherein said second housing part comprises a drug vial having an inlet structure for engaging said first housing part.

37. A medical luer receiver as in claim 34, wherein said second housing part comprises a fluid collecting vessel having an inlet end configured for engaging said first housing part, rigid side walls and a substantially continuously curved bottom wall.

38. A medical luer receiver as in claim 34, wherein said second housing part comprises an inlet port defined in a side wall of blood tubing.

39. A medical luer receiver as in claim 34, wherein said second housing part comprises an inlet port to an I.V. bag.

40. A medical luer receiver as in claim 34, wherein said second housing part comprises a stop cock housing, said stop cock housing having an outlet port and a stop cock valve stem for providing selective flow communication between said first housing part and said outlet port.

41. A medical luer receiver as in claim 11, further comprising a plug formed from a second elastomeric material provided at one of a proximal end and a distal end of said central slit, said elastomeric plug being formed from a material having a tear resistance lower than a tear resistance of the first elastomeric.

42. A medical luer receiver as in claim 11, further comprising first and second relief slits defined part way through said septum from a bottom surface thereof, said relief slits being defined in a plane substantially perpendicular to a plane of said central slit.

43. A medical luer receiver as in claim 11, wherein said septum comprises a duck-billed valve structure at a distal end of said central slit.

44. A medical luer receiver as in claim 11, wherein said central slit has a generally uniform transverse length along substantially an entire extent thereof.

45. A medical luer receiver as in claim 11, wherein said central slit has a transverse length that decreases from a first dimension in said proximal portion of said septum to a second, reduced dimension distal therefrom.

46. A medical luer receiver as in claim 45, wherein the transverse length of said slit tapers from said first dimension to said second, reduced dimension.

47. A medical luer receiver as in claim 45, wherein said transverse length of said slit is stepped from said first dimension to said second, reduced dimension adjacent a distal end of said slit.

48. A luer receiver for connecting with a luer lock connector having a male luer tip and a surrounding female threaded end, the receiver comprising:

a housing having a side wall, a proximal end, a distal end, and a bore extending from said proximal end towards distal end, said proximal end of said housing being sized to be received into said luer lock connector, said housing further including a transverse wall portion;

a septum having a longitudinal axis and mounted at least partially within said bore adjacent said proximal end, said septum having an upper face and a slit extending from said face at least partially through said septum, said septum being sized and configured to receive at least a portion of said male luer end into said septum through said face and through at least a portion of said slit, at least a portion of said septum being displaced lateral to said longitudinal axis by said luer tip when said luer tip is advanced into said septum to define a displaced septum portion;

a receptacle being defined by said transverse wall portion and said side wall, said receptacle and said septum being sized and configured such that said displaced septum portion is received into said receptacle under said wall portion and into contact with said side wall when said luer tip is advanced into said slit.

49. The luer receiving valve of claim 48, wherein said receptacle is further defined by at least one cut out in at least one of said septum and said side wall.

50. The luer receiving valve of claim 49, wherein said cut out extends only partially through said side wall.

51. The luer receiving valve of claim 50, wherein said transverse wall portion comprises a rim positioned adjacent said proximal end of said housing.

52. The luer receiving valve of claim 49, wherein said receptacle is defined by a recess in said side wall, said transverse wall portion comprising an upper wall of said recess.

53. The luer receiving valve of claim 48, wherein said transverse wall portion has a lower surface at least partially inclined toward said distal end, said surface being sized and configured such that said displaced septum portion engages said surface when said luer tip is advanced into said slit.

54. A luer receiver for connecting with a luer lock connector having a male luer tip and a surrounding female threaded end, the receiver comprising:

a housing having an inner wall, a proximal end, a distal end, and a bore extending from said proximal end towards distal end, said proximal end of said housing being sized to be received into said luer lock connector,

a septum defining a longitudinal axis and mounted at least partially within said bore adjacent said proximal end, said septum having an upper face and a slit extending from said face at least partially through said septum, said septum being sized and configured to receive at least a portion of said male luer end into said septum through said face and through at least a portion of said slit, at least a portion of said septum being displaced lateral to said longitudinal axis by said luer tip when said luer tip is advanced into said septum to define a displaced septum portion,

at least one cavity defined at a periphery of said septum for receiving at least a portion of said displaced septum portion upon insertion of said tip into said septum, said cavity having a distal end, and

a seal being provided adjacent said distal end of said cavity for sealing said cavity.

55. The luer receiving valve of claim 54, wherein said septum comprises at least one lateral wall and wherein said cavity is defined by a recess in said lateral wall.

56. The luer receiving valve of claim 54, wherein said seal is comprised by tight sealing contact between said septum and said housing distal of said cavity.

57. The luer receiving valve of claim 54, wherein said housing further defines a fluid chamber distal of said septum, said seal isolating said cavity from said fluid chamber.

58. A method of placing a septum of a luer receiver having a slit into a configuration inducing enhanced sealing, the septum having a proximal end defining an outer face and a slit extending from said outer face at least partially through said septum, the septum further including a lateral portion, the method including the step of:

displacing said lateral portion of said septum in a generally proximal direction, said displacement of said lateral portion inducing tight sealing of said slit at said face.

59. The method of claim 58, further including axially compressing said septum below said outer face to seal said slit below said outer face.

60. The method of claim 59, wherein said septum is axially compressed by said luer receiver.

61. The method of claim 59, wherein said displacing step wedges said slit to induce said tight seal.

62. The method of claim 58, wherein said lateral portion is displaced by said luer receiver.

63. A method for the transfer of fluid, comprising the steps of:

providing a medical luer receiver, including;

a housing having a proximal portion, a central portion, and a distal portion, and a bore extending axially through said proximal and said central portions into said distal portion; and

a septum formed at least in part from an elastomeric material and having an outer face, a proximal portion, an extension portion, and a central slit defined at least partially therethrough, said septum proximal portion including an upper portion having a width greater than a width of said extension portion, a proximal end of said housing comprising a substantially continuous ring structure defining a platform, said upper portion of said septum being seated on said platform;

pressing a male luer tip of another medical device against the outer face of the septum, the ring structure holding the upper portion of the septum in position while the luer tip penetrates into the slit and into the septum;

deflecting walls of said slit laterally such that opposing inner faces of said walls directly press against an outer wall of said cannula after the luer tip has been advanced into the slit, and

flowing liquid through the luer tip and into said distal portion of said housing.

64. A method as in claim 63, wherein a threaded shroud surrounds said male luer tip and said method further comprises threading the lock shroud about the housing such that the septum, the luer tip, and at least a portion of the housing are retained within the shroud.

65. A method of transferring medical liquid between a medical liquid storage container and a chamber using a luer connector, the connector having a central male luer cannula, the connector being mounted in fluid connection with the container, the chamber having a luer receiver mounted in flow communication therewith, the receiver including a housing having an inlet, the housing containing a sealing septum mounted adjacent the inlet, the septum having an upper portion including an outer face and a perforation, the septum including a septum extension projecting axially of the housing, said septum upper portion having a width greater than a width of said septum extension, a proximal end of said housing comprising a substantially continuous ring structure defining a platform, said upper portion of said septum being seated on said platform;

the method comprising steps of;

pressing a tip of the male luer cannula against the outer face, the ring structure holding the upper portion of the septum in position adjacent the inlet such that the upper portion is held while the luer tip penetrates into the slit and into the outer face of the septum and into the extension,

deflecting the extension laterally with the luer cannula such that the extension is elastically expanded within the housing in direct contact with the male luer cannula, the cannula penetrating at least partially through the extension into fluid connection with the chamber, and

flowing liquid through the luer tip and into the chamber.