Systems and methods for providing a flushable catheter assembly

• US 8,574,203 B2
• Filed: 03/07/2011
• Issued: 11/05/2013
• Est. Priority Date: 02/11/2009
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Stout, Marty L., Harding, Weston F., Isaacson, S. Ray, Burkholz, Jonathan K., McKinnon, Austin Jason
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US13/042,103
• Publication Number:
  US 20110160662A1
• Time in Patent Office: 974 Days
• Field of Search: 604/164.01, 604/164.02, 60416701-16706, 604/168.01, 604244-246, 604/249, 604/284, 604/533
• US Class Current: 604/244
• CPC Class Codes: A61M 2039/062 used with a catheter
• CPC Class Codes: A61M 2039/0633 the seal being a passive seal made of a resilient material with or without an opening
• CPC Class Codes: A61M 2039/064 Slit-valve
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• CPC Class Codes: A61M 39/0606 without means for adjusting the seal opening or pressure A61M39/0693 takes precedence
• 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: Y10T 29/49826 Assembling or joining

Abstract

A flushable catheter assembly having features to enable selective activation of fluid flow through the catheter assembly is disclosed herein. A septum is placed within the catheter adapter of the catheter assembly and includes a pathway that is closed prior to being biased open via a septum activator also positioned within the catheter adapter. A plurality of air vent channels is interposed between the septum and the inner surface of the catheter adapter to permit “flashback” of blood during insertion of the catheter into a patient. The septum activator is advanced through the pathway of the septum as a coupler is attached to a proximal opening of the catheter adapter.

Claims

1. A system for controlling fluid flow in a closed IV catheter assembly, comprising:

a luer port having an inner lumen;

a valve for controlling fluid flow through the inner lumen, the valve comprising;

a septum disposed within a portion of the inner lumen;

a septum activator disposed within a portion of the inner lumen adjacent to the septum, wherein a distal end of the septum activator contacts a proximal surface of the septum when the valve is in an unactuated position, and extends through the proximal surface when the valve is in an actuated position, the septum activator further including a sealing portion that extends from an exterior surface of the septum activator and contacts the surface of the inner lumen thereby preventing fluid from flowing into interstitial spaces between the septum and the sealing portion of the septum activator; and

a ventilation channel interposed between the septum and an inner surface of the inner lumen of the luer port, the ventilation channel having a surface area and a perimeter selected to permit passage of at least one of air and blood at a desired rate of flow when the valve is in the unactuated position.

2. The system of claim 1, wherein the sealing portion comprises a sleeve attached around the septum activator.

3. The system of claim 1, wherein the sealing portion comprises a toroidal-shaped band around the outer circumference of the septum activator.

4. The system of claim 1, wherein the septum activator comprises a plurality of vents and flow diverters configured to improve circulation of the fluid within at least one of the septum activator and an interstitial space between the septum activator and the inner surface of the inner lumen.

5. The system of claim 3, wherein the septum activator further comprises a flow vent.

6. The system of claim 1, wherein the proximal surface of the septum further includes a cavity for housing the distal end of the septum activator, and wherein a distal surface of the septum is dome-shaped.

7. The system of claim 6, further comprising a relief located on an inner surface of the cavity, the relief being configured to receive a retaining feature located on the distal end of the septum activator, wherein an interaction between the retaining feature and the relief prevents removal of the septum activator from the septum.

8. The system of claim 1, wherein the ventilation channel permits the passage of air but not the passage of blood while the valve is in the unactuated position.

9. The system of claim 1, wherein the luer port comprises a y-luer port.

10. The system of claim 1, wherein the luer port comprises a straight luer port.

11. The system of claim 1, wherein the proximal surface of the septum includes a slit.

12. The system of claim 11, wherein the slit comprises a leak orifice.

13. A closed IV catheter assembly, comprising:

a luer port having an inner lumen, the inner lumen having a proximal end, a distal end and a middle portion;

a recess forming the middle portion of the inner lumen, the recess being configured to receive a septum, the septum forming a defeatable barrier between the proximal end and the distal end of the inner lumen;

a ventilation channel interposed between the septum and an inner surface of the inner lumen of the luer port, the ventilation channel having a surface area and a perimeter selected to permit passage of at least one of air and blood between the proximal end and the distal end of the inner lumen, at a desired rate of flow;

a septum activator positioned within the proximal end of the inner lumen, the septum activator having a first end for biasing open a slit of the septum, and a second end having a contact surface, the septum activator further including a sealing portion that extends from an exterior surface of the septum activator and contacts the surface of the inner lumen thereby preventing fluid from flowing into interstitial spaces between the septum and the sealing portion of the septum activator; and

an opening forming a proximal end of the luer port, wherein an external device is inserted through the opening to contact the contact surface of the septum activator thereby advancing the first end of the septum activator through the slit of the septum, wherein the ventilation channel permits the passage of at least one of air and blood before the first end of the septum activator is advanced through the slit of the septum.

14. The assembly of claim 13, further comprising a flow vent forming a portion of the septum activator.

15. The assembly of claim 13, wherein the septum activator further comprises a plurality of vents and flow diverters configured to improve circulation of a fluid within at least one of the septum activator pathway and an interstitial space between the septum activator and the inner surface of the luer port inner lumen.

16. The assembly of claim 13, wherein a proximal surface of the septum further includes a cavity for housing a distal end of the septum activator, and wherein a distal surface of the septum is dome-shaped.

17. The system of claim 16, further comprising a relief located on an inner surface of the cavity, the relief being configured to receive a retaining feature located on a distal end of the septum activator, wherein an interaction between the retaining feature and the relief prevents removal of the septum activator from the septum.

18. The system of claim 13, further comprising an antimicrobial coating applied to at least one of the luer port, the septum, the ventilation channel, the septum activator and the external device.

19. The system of claim 13, wherein the ventilation channel permits the passage of air but not the passage of blood before the first end of the septum activator is advanced through the slit of the septum.

20. The system of claim 13, wherein the slit further comprises a leak orifice.