CATHETER ASSEMBLY WITH SEAL MEMBER

• US 20110319825A1
• Filed: 02/08/2011
• Published: 12/29/2011
• Est. Priority Date: 06/25/2010
• Status: Active Grant

• Current Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Original Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Inventors: Muskatello, James, Goral, David J., Roehl, Christopher D., Munavalli, Mahesh, Michaud, Jocelyn C.
• Granted Patent: US 8,652,104 B2
• Time in Patent Office: Days
• US Class Current: 604/164.01
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0014 Connecting a tube to a hub
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 25/0618 having means for protecting only the distal tip of the needle, e.g. a needle guard
• CPC Class Codes: A61M 25/0693 Flashback chambers
• CPC Class Codes: Y10T 29/49826 Assembling or joining
• CPC Class Codes: Y10T 29/4987 Elastic joining of parts
• CPC Class Codes: Y10T 29/49872 Confining elastic part in socket

Abstract

A catheter assembly includes a catheter hub defining an interior cavity and a catheter tube extending distally thereof. A rigid actuator extends proximally in the interior cavity and supports a seal member thereon. The seal member includes a central membrane, a distal portion, and a proximal portion. An hourglass shaped actuator cavity is formed in the distal portion and receives a barbed end of the actuator. The outer surface of the seal member is in partial circumferential engagement with the catheter hub to define an air path that allows fluid communication between areas of the interior cavity distal and proximal of the seal member. A punch tool is provided to form a tri-slit in the membrane of the seal member. The seal member may be configured for multi-use and include a biasing member that moves the seal member to force the membrane back over the actuator to close the membrane.

Claims

1. A catheter assembly comprising:

a catheter hub having an open proximal end and a distal end, with an inner surface extending therebetween and defining an interior cavity of the catheter hub, and a catheter tube extending distally from the catheter hub distal end;

a rigid actuator extending proximally in the interior cavity of the catheter hub from the catheter hub distal end to a free end; and

a seal member disposed in the interior cavity of the catheter hub, the seal member including a membrane, a distal portion extending distally from the membrane to a sealing outlet bore, and a biasing member between the sealing outlet bore and the distal end of the catheter hub, the distal portion having an actuator cavity therein between the membrane and the sealing outlet bore, the actuator extending through the sealing outlet bore into the actuator cavity, the membrane being normally closed, the seal member being axially shiftable along the actuator in a distal direction to force the membrane over the free end of the actuator and open the membrane, the biasing member configured to axially shift the seal member along the actuator in a proximal direction to force the membrane back over the free end of the actuator and close the membrane, the biasing member being partially compressed when the membrane is closed.

2. The catheter assembly of claim 1, the seal member being a unitary member.

3. The catheter assembly of claim 1, the biasing member including a tubular extension member.

4. The catheter assembly of claim 1, the biasing member including at least one leg.

5. The catheter assembly of claim 1, the biasing member including a pair of opposed legs.

6. The catheter assembly of claim 1, the biasing member including a proximal tubular extension portion and a distal portion including a pair of legs.

7. The catheter assembly of claim 6, each of the legs of the biasing member including a flange configured to engage a groove in the inner surface of the interior cavity to facilitate securement of the seal member within the catheter hub.

8. The catheter assembly of claim 1, the actuator having a shaft, the shaft sized to fit sealingly within the sealing outlet bore.

9. The catheter assembly of claim 1, the membrane being slit to define slit flaps adapted to distend as the membrane is forced over the free end of the actuator.

10. The catheter assembly of claim 1, the seal member including a proximal portion extending proximally from the membrane, and sized to present an impact surface to a free end of a luer taper, such that insertion of a luer taper into the catheter hub interior cavity impacts the impact surface of the seal member causing the seal member to slide axially along the actuator.

11. The catheter assembly of claim 1 further comprising a needle cannula having a sharp distal tip, the needle cannula extending through the seal member and catheter tube with the sharp distal tip being exposed distally of the catheter tube.

12. The catheter assembly of claim 11 further comprising a nose extending into the catheter hub interior cavity, the needle cannula extending distally of the nose.

13. A catheter assembly comprising:

a catheter hub having an open proximal end and a distal end defining an interior cavity therebetween, with a catheter tube extending distally from the catheter hub distal end;

a rigid actuator extending proximally in the interior cavity of the catheter hub from the catheter hub distal end to a free end, the actuator having an enlarged proximal flange at the free end thereof; and

a seal member disposed in the interior cavity of the catheter hub, the seal member including a membrane, a distal portion extending distally from the membrane to a sealing outlet bore, and a biasing member between the sealing outlet bore and the distal end of the catheter hub, the distal portion having an actuator cavity therein between the membrane and the sealing outlet bore, the actuator cavity having a narrowed portion defining an hourglass shape thereto, the actuator extending through the sealing outlet bore into the actuator cavity.

14. The catheter assembly of claim 13, the seal member being a unitary member.

15. The catheter assembly of claim 13, the biasing member including a tubular extension member.

16. The catheter assembly of claim 13, the biasing member including at least one leg.

17. The catheter assembly of claim 13, the biasing member including a proximal tubular extension portion and a distal portion including a pair of legs, each of the legs of the biasing member including a flange configured to engage a groove in an inner surface of the interior cavity to facilitate securement of the seal member within the catheter hub.

18. The catheter assembly of claim 13, the proximal flange of the actuator being completely contained within the actuator cavity and having an outer cross dimension larger than a cross dimension of the sealing outlet bore.

19. The catheter assembly of claim 13, the membrane being normally closed to seal the actuator cavity, the seal member being axially slidable along the actuator to force the membrane over the proximal flange and open the membrane, the biasing member configured to axially slide the seal member along the actuator to force the membrane back over the proximal flange and close the membrane.

20. The catheter assembly of claim 19, the membrane being slit to define slit flaps adapted to distend as the membrane is forced over the proximal flange.

21. The catheter assembly of claim 19, the seal member including a proximal portion extending proximally from the membrane, and sized to present an impact surface to a free end of a luer taper, such that insertion of a luer taper into the catheter hub interior cavity impacts the impact surface of the seal member causing the seal member to slide axially along the actuator.

22. The catheter assembly of claim 13 further comprising a needle cannula having a sharp distal tip, the needle cannula extending through the seal member and catheter tube with the sharp distal tip being exposed distally of the catheter tube.

23. The catheter assembly of claim 22 further comprising a nose extending into the catheter hub interior cavity, the needle cannula extending distally of the nose.

24. A catheter assembly comprising:

a catheter hub having an open proximal end and a distal end, with an inner surface extending therebetween and defining an interior cavity of the catheter hub, and a catheter tube extending distally from the catheter hub distal end;

a rigid actuator extending proximally in the interior cavity of the catheter hub from the catheter hub distal end to a free end; and

a seal member disposed in the interior cavity of the catheter hub and supported on the rigid actuator, the seal member having a biasing member configured to engage with the catheter hub to bias the seal member in a first direction, the seal member further having an outer surface in partial circumferential engagement with the catheter hub inner surface such that an air path is maintained between areas of the interior cavity distal and proximal of the seal member.

25. The catheter assembly of claim 24, the seal member being a unitary member.

26. The catheter assembly of claim 24, the biasing member including a tubular extension member.

27. The catheter assembly of claim 24, the biasing member including at least one leg.

28. The catheter assembly of claim 24, the biasing member including a proximal tubular extension portion and a distal portion including a pair of legs, each of the legs of the biasing member including a flange configured to engage a groove in the inner surface of the interior cavity to facilitate securement of the seal member within the catheter hub.

29. The catheter assembly of claim 24, the seal member including at least one groove axially extending along the exterior surface, the outer surface in circumferential engagement with the catheter hub inner surface except in the area of the groove, the groove defining at least a portion of the air path.

30. The catheter assembly of claim 24, a portion of the seal member outer portion being spaced from a confronting portion of the catheter hub inner portion to define at least a portion of the air path.

31. A method of making a catheter assembly comprising:

positioning a rigid actuator in an interior cavity of the catheter hub having an open proximal end and a distal end, with an inner surface extending therebetween and defining the interior cavity of the catheter hub, and a catheter tube extending distally from the catheter hub distal end, the actuator extending proximally in the interior cavity from a catheter hub distal end to a free end;

obtaining a seal member having a membrane, a distal portion extending distally from the membrane to a sealing outlet bore, and a biasing member, the distal portion having an actuator cavity therein between the membrane and the sealing outlet bore; and

positioning the seal member in the interior cavity of the catheter hub such that the actuator extends through the sealing outlet bore and into the actuator cavity, and the biasing member is partially compressed so as to apply a biasing force on the seal member when the membrane is closed.