Needless luer access connector

• US 20030208165A1
• Filed: 05/01/2002
• Published: 11/06/2003
• Est. Priority Date: 05/01/2002
• Status: Abandoned Application

• Current Assignee: Carolyn Elizabeth Brown, Greg L. Brimhall, Kelly David Christensen, Ralph L. Sonderegger, Weston F. Harding, William Gary Moulton
• Original Assignee: Carolyn Elizabeth Brown, Greg L. Brimhall, Kelly David Christensen, Ralph L. Sonderegger, Weston F. Harding, William Gary Moulton
• Inventors: Moulton, William Gary, Brown, Carolyn Elizabeth, Christensen, Kelly David, Harding, Weston F., Sonderegger, Ralph L., Brimhall, Greg L.
• Application Number:
  US10/136,994
• Publication Number:
  US 20030208165A1
• Time in Patent Office: Days
• US Class Current: 604/256
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61M 2039/266 where the valve comprises venting channels, e.g. to insure better connection, to help decreasing the fluid space upon disconnection, or to help the fluid space to remain the same during disconnection
• CPC Class Codes: A61M 39/045 pre-slit to be pierced by blunt instrument
• CPC Class Codes: A61M 39/26 Valves closing automatically on disconnecting the line and opening on reconnection thereof check valves A61M39/24

Abstract

A needleless luer access connector is disclosed having a septum disposed in a housing. The septum has a proximal portion with a cross section, a medial portion with a cross section smaller than the cross section of the proximal portion, and a distal portion. A longitudinal slit extends through the septum from the proximal portion to the distal portion. The septum and housing are designed so that septum will not be rotated or removed from the housing when the connector is accessed by a male luer taper. In addition, the septum and housing are designed to bias the slit at the distal portion closed and so a male luer connector does not have to extend completely through the distal portion to open the slit at the distal portion. Finally, the septum and housing are designed to minimize the amount of dead space in the connector when accessed with a male luer taper.

Claims

1. A needleless luer access connector including:

a substantially cylindrical base having an axis extending from a proximal direction to a distal direction;

leaf springs attached to the base and extending in the proximal direction, thereby defining a channel, wherein the channel has a cross section;

a septum having a proximal portion, a medial portion and a distal portion, wherein the proximal portion and the distal portion have circular cross sections when not stressed and wherein the medial portion has an oval cross section when not stressed, the oval cross section having a major axis and a minor axis;

wherein the distal portion of the septum is disposed within the base, the medial portion of the septum is disposed within the channel and the proximal portion is seated on the leaf springs remote from the base;

wherein at least one first leaf spring is operably engaged to the medial portion of the septum along the major axis of the medial portion;

wherein at least one second leaf spring is operably engaged to the medial portion of the septum along the minor axis of the medial portion; and

a longitudinal slit extending through the septum from the proximal portion through the medial portion and into the distal portion such that, when a male luer taper is inserted into the slit, the medial portion is expanded.

2. The needleless luer access connector of claim 1 further including a lip attached at a proximal end of at least one of the leaf springs such that the lip encloses at least a portion of the proximal portion of the septum.

3. The needleless luer access connector of claim 1 further comprising an adhesive material disposed between the septum and the leaf springs, securing the septum to the leaf springs.

4. The needleless luer access connector of claim 1 further comprising two leaf springs operably engaged to the medial portion of the septum along the minor axis of the oval cross section wherein, when a male luer taper is inserted into the slit, the medial portion is expanded, thereby deflecting the leaf springs outwardly.

5. The needleless luer access connector of claim 1 wherein the second leaf spring extends in the proximal direction from the base, angled toward the axis and contacting the septum only at a proximal end of the second leaf spring.

6. The needleless luer access connector of claim 1 wherein the medial portion of the septum includes a rib extending substantially in a radial direction along the minor axis and contacting at least one leaf spring.

7. The needleless luer access connector of claim 1 further including:

a lip attached at a proximal end of the leaf springs such that the lip encloses at least a portion of the proximal portion of the septum;

an adhesive material disposed between the septum and the leaf springs, securing the septum to the leaf springs;

two first leaf springs operably engaged to opposite sides of the medial portion of the septum along the major axis of the cross section;

two second leaf springs extending in the proximal direction angled toward the axis and operably engaged to opposite sides of the medial portion of the septum along the minor axis of the oval cross section wherein, when a male luer taper is inserted into the slit, the medial portion is expanded, deflecting the leaf springs outwardly.

8. A connector for use with a male taper including:

a housing with a base;

leaf springs attached to the base and defining a channel, wherein the channel has a cross section;

a septum having a proximal portion and a medial portion, wherein the medial portion of the septum is disposed within the channel and the proximal portion is seated on the leaf springs remote from the base; and

a longitudinal slit extending through the septum from the proximal portion through to the medial portion such that, when a male taper is inserted into the slit, the slit is moved from a closed condition, in which the septum prevents fluid flow through the housing, to an open position, in which fluid may flow through the septum;

wherein the leaf springs are operably engaged to the septum, biasing the septum to the closed condition.

9. The connector of claim 8 in which at least one rib is mounted to the medial portion of the septum, which rib engages at least one of the leaf springs.

10. The connector of claim 9 wherein the medial portion of the septum has an exterior surface and wherein the rib is connected to the exterior of the medial portion and to a bottom surface of a proximal portion of the septum.

11. The connector of claim 9 wherein the rib is integrally formed with the septum.

12. The connector of claim 9 further comprising an adhesive material disposed between the leaf springs and the septum, securing the septum to the leaf springs.

13. The connector of claim 12 further comprising a lip disposed at a proximal portion of the leaf springs enclosing at least a portion of the proximal portion of the septum and biasing the proximal portion of the septum toward a closed condition.

14. A needleless access connector including:

a housing having a base portion with a proximal surface and a sidewall positioned on the base portion, wherein the sidewall includes a top portion having a periphery and defining an inlet opening and the sidewall defines a channel having a cross section, wherein the inlet opening and the channel are in fluid flow communication;

a septum disposed in the housing, the septum having a proximal portion, a medial portion and a distal portion, the medial portion having an external surface and a cross section less than the cross section of the proximal portion and less than the cross section of the channel;

a longitudinal slit having a transverse axis extending through the septum from the proximal portion through the medial portion and into the distal portion such that, when a male luer taper is inserted into the slit, the distal portion is moved both laterally and distally to open a flow path through the channel; and

a lip attached at the periphery of the top portion of the housing such that the lip encloses at least a portion of the proximal portion of the septum.

15. The needleless access connector of claim 14 wherein the lip extends contiguously around the periphery of the top portion.

16. The needleless access connector of claim 14 wherein the proximal portion of the septum has a peripheral rim with a thickness and the lip has a height, wherein the height of the lip is less than the thickness of the peripheral rim.

17. The needleless access connector of claim 14 wherein the proximal portion of the septum has a peripheral rim with a thickness and the lip has a height, wherein the height of the lip is equal to or greater than the thickness of the peripheral rim.

18. The needleless access connector of claim 14 wherein the lip is integrally formed with the top portion of the housing.

19. The needleless access connector of claim 14 wherein the lip comprises a plurality of discrete tabs.

20. The needleless access connector of claim 14 further comprising an adhesive disposed between the proximal portion of the septum and the top portion of the sidewall and wherein the lip exerts a compressive force on the proximal portion of the septum.

21. The needleless access connector of claim 14 wherein the lip exerts a compressive force in a direction perpendicular to the transverse axis of the slit.

22. The needleless access connector of claim 14 wherein the top portion of the housing includes two diametrically opposed high points and two diametrically opposed low points.

23. The needleless access connector of claim 14 wherein the diametrically opposed low points are disposed along the transverse axis of the slit.

24. The needleless access connector of claim 14 wherein the sidewall of the housing is formed by a plurality of leaf springs mounted to the base portion.

25. A needleless luer access connector including:

a housing having a base portion defining a base opening, elastic members positioned on the base portion about the base opening and defining a channel, and a top edge disposed on the elastic members distal to the base portion, wherein the top edge defines an inlet opening and the channel has a cross section;

a valve disposed in the housing, the valve having a proximal portion, a medial portion and a distal portion, the medial portion having an external surface and being disposed, at least in part, within the channel; and

a longitudinal slit extending through the valve along a transverse axis from the proximal portion through the medial portion and into the distal portion such that, when a male luer taper is inserted into the slit, the valve is deformed such that the distal portion is moved both laterally and distally and the medial portion is expanded to contact and displace the elastic members such that the elastic members exert a reactive force urging the slit to a closed position.

26. The luer access connector of claim 25 further including a lip attached at the periphery of the top edge of the housing such that the lip encloses at least a portion of the proximal portion of the valve.

27. The luer access connector of claim 25 wherein the medial portion of the valve has an oval cross section with a major axis and a minor axis, and wherein the elastic members include two side members which are disposed on opposite sides of the medial portion along the minor axis and wherein the two side members are in contact with the valve when the valve is undeformed.

28. The luer access connector of claim 27 wherein the elastic members include two end members disposed on opposite side of the medial portion along the major axis and wherein the two end members are in contact with the valve when the valve is undeformed.

29. The luer access connector of claim 27 wherein the medial portion of the valve further comprises at least one rib disposed, at least in part, along the minor axis and engaging at least one side member.

30. The luer access connector of claim 29 wherein the rib extends from the proximal portion of the valve along the medial portion.

31. The luer access connector of claim 27 wherein the medial portion of the valve further comprises two ribs disposed on opposite side of the medial portion and, at least in part, along the minor axis, each rib engaging a side member.

32. A method of forming an infusion site for permitting selective infusion of fluids into a patient by means of a blunt cannula, the method including:

providing a housing that has a top portion with a top surface defining an inlet opening, at least one sidewall extending from the top portion and defining a channel, and a base portion having an outlet opening such that the inlet opening and the outlet opening are in fluid flow communication;

inserting a septum in the housing, the septum having a proximal portion, a medial portion and a distal portion, the proximal portion having a distal surface disposed at the top surface of the housing and the medial portion disposed, at least in part, in the channel of the housing;

wherein the septum defines a slit passing at least through the proximal portion;

applying an adhesive to the housing and the septum;

deforming the septum into a compressed state, thereby urging the slit to a closed position; and

curing the adhesive such that the septum is maintained in the compressed state by the cooperation of the cured adhesive and the housing.

33. The method of forming an infusion site of claim 32 wherein the adhesive is applied at a groove formed by the proximal portion of the septum and the top portion of the housing.

34. The method of forming an infusion site of claim 32 further comprising displacing the proximal portion of the septum from the top surface of the housing to create a gap, wherein the adhesive is injected into the gap.

35. The method of forming an infusion site of claim 32 wherein the adhesive is a UV curable adhesive and at least the top portion of the housing is formed of a translucent material, the method further comprising:

providing a UV light source;

selectively delivering UV light from the light source, through the top portion of the housing to the adhesive; and

curing the adhesive by application of the UV light.

36. The needleless luer access connector of claim 32 wherein the adhesive is a weld.

37. A method of forming a needleless access connector, including:

providing a housing that has a top portion with a top surface defining an inlet opening, at least one sidewall extending from the top portion and defining a channel having a cross section, and a bottom portion having an upper surface defining an upper cavity and an outlet opening extending from the upper cavity such that the inlet opening and the outlet opening are in fluid flow communication;

providing a septum having a proximal portion, a medial portion and a distal portion, the proximal portion having a distal surface and the medial portion having an external surface with a cross section that is less than the cross section of the channel wherein the septum includes a longitudinal slit extending along a transverse axis through the septum from the proximal portion through the medial portion and into the distal portion;

wherein, when a male luer taper is inserted into the slit, the distal portion is moved both laterally and distally into contact with the upper surface of the upper cavity;

inserting the septum into the housing such that the proximal portion of the septum is seated on the top surface of the housing, the medial portion of the septum is seated in the channel and the distal portion is disposed in the bottom portion;

applying a compressive force to the septum in a direction that is perpendicular, at least in part, to the transverse axis; and

securing the housing and the septum in a fixed spatial relationship while applying the compressive force.

38. The method of forming a needleless access connector of claim 37 wherein the top portion of the housing includes two diametrically opposed high points and two diametrically opposed low points and wherein the diametrically opposed low points are disposed along the transverse axis of the slit.

39. The method of forming a needleless access connector of claim 37 further comprising applying an actuator to the proximal portion of the septum and the top surface of the housing to create a gap, applying an adhesive into the gap, and curing the adhesive in the gap.

40. The method of forming a needleless access connector of claim 39 wherein the adhesive is selected from the group containing UV curable adhesives, thermoset adhesives, cynoacrylate adhesives, moisture cure adhesives, pressure cure adhesives, epoxy or RTV adhesives.

41. The method of forming a needleless access connector of claim 40 wherein the adhesive is a UV curable adhesive and either the top portion of the housing or the proximal portion of the septum is formed of a translucent material, the method further comprising providing a UV light source, delivering UV light from the light source, through the top portion of the housing to the adhesive, curing the adhesive by application of the UV light.

42. The method of claim 37 wherein securing the top surface of the housing and the distal surface of the proximal portion of the septum in a fixed relationship comprises welding the housing to the septum.

43. The method of claim 42 wherein the weld is formed by one of the group of ultrasonic welding, laser welding or heat staking.

44. A needleless luer access connector including:

a housing comprising a top portion with a top surface defining an inlet opening, at least one sidewall extending from the top portion and defining a channel, and a bottom portion having an outlet opening such that the inlet opening and the outlet opening are in fluid communication;

a septum seated on the top surface of the housing, and having a resealable slit therein, the slit being movable from a closed position in which a fluid-tight seal is formed to an open position in which a fluid flow path is established through the septum;

an adhesive operably engaged to the housing and the septum, securing the septum to the top surface of the housing in a compressed state wherein the resealable slit is urged toward the closed position.

45. The needleless luer access connector of claim 44 further comprising a valve operably engaged to the housing for selectively permitting fluid flow through the channel.

46. The needleless luer access connector of claim 45 further comprising an elastic member connecting the valve to the septum.

47. The needleless luer access connector of claim 46 wherein the elastic member is disposed within the channel, free to slide with respect to the housing.

48. The needleless luer access connector of claim 44 wherein the rescalable slit is disposed in a transverse plane and the adhesive is substantially disposed on an adhesive plane, wherein the adhesive plane and the transverse plane are substantially perpendicular and wherein the septum is compressed in a direction that is perpendicular, at least in part, with the transverse plane.