Low drag, high pressure septum

• US 9,108,021 B2
• Filed: 02/22/2012
• Issued: 08/18/2015
• Est. Priority Date: 02/22/2012
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Hyer, Daniel Kirk, Christensen, Corey, Ellis, Carl
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): LEE, WENG WAH
• Application Number:
  US13/402,133
• Publication Number:
  US 20130218082A1
• Time in Patent Office: 1,273 Days
• Field of Search: 604244-246, 604/167.02, 604/167.01, 604/256, 604/167.06, 251/30.02, 251/30.05
• US Class Current: 1/1
• 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 2039/064 Slit-valve
• CPC Class Codes: A61M 2039/0666 Flap-valve
• 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

Abstract

A septum is disclosed that can be utilized in a catheter assembly to selectively seal an opening in the catheter assembly. The septum has a tube portion and a plug portion. The plug portion has a slit extending through it. The septum can transition from a non-collapsed state to a collapsed state. When the septum is in a non-collapsed state, the plug portion is offset from the tube portion such that some of the length of the slit extends outward from the distal end of the tube portion. When the septum transitions to the collapsed state, the plug portion is moved inward into the internal cavity such that some of the length of the slit may or may not extend outward from the distal end of the tube portion.

Claims

1. A septum comprising:

a tube portion having an internal cavity therein; and

a plug portion coupled to a distal end of the tube portion having a non-collapsed state and a collapsed state, the plug portion having a slit extending therethrough, the slit having a slit length extending between a distal end of the plug portion and a proximal end of the plug portion, the plug portion being offset from the tube portion such that when the septum is in the non-collapsed state some of the length of the slit extends distally from the distal end of the tube portion, when the septum transitions to the collapsed state the plug portion is moved proximally into the internal cavity such that less of the length of the slit extends distally from the distal end of the tube portion and such that, when in the collapsed state, the tube portion applies an inward radial force against the plug portion to thereby seal the slit to prevent a fluid from passing through the slit.

2. The septum of claim 1, wherein the septum transitions from the non-collapsed state to the collapsed state in response to a pressure on a distal face of the septum that exceeds a threshold pressure.

3. The septum of claim 2, wherein the threshold pressure is greater than a pressure produced by withdrawing an introducer needle through the slit in the plug portion.

4. The septum of claim 1, wherein the plug portion extends from a central portion of the distal end of the tube portion.

5. The septum of claim 4, wherein the distal end of the tube portion forms an annular surface around the plug portion.

6. The septum of claim 1, wherein the internal cavity extends from a proximal end of the tube portion to the plug portion.

7. The septum of claim 1, wherein the internal cavity has a first cross sectional area, taken perpendicular to a central axis of the tube portion, that is smaller than a second cross-sectional area of the plug portion, taken perpendicular to the central axis of the tube portion at a location distal from the distal end of the tube portion.

8. The septum of claim 1, wherein the septum is a one-piece, elastomeric septum.

9. A catheter assembly, comprising:

a catheter adapter having an inner lumen;

a septum disposed within the inner lumen of the catheter adapter, the septum being able to transition from a non-collapsed state to a collapsed state;

a tube portion of the septum having a proximal end and a distal end, the tube portion forming an internal cavity; and

a plug portion of the septum coupled to the distal end of the tube portion, the plug portion having a slit extending therethrough, the slit having a slit length, the plug portion being offset from the tube portion such that when the septum is in the non-collapsed state some of the length of the slit extends distally from the distal end of the tube portion, when the septum is in the collapsed state, the plug portion is moved proximally into the internal cavity such that less of the length of the slit extends distally from the distal end of the tube portion and such that, when in the collapsed state, the tube portion applies an inward radial force against the plug portion to thereby seal the slit to prevent a fluid from passing through the slit.

10. The catheter assembly of claim 9, wherein a diameter of the internal cavity is smaller than a diameter of the plug portion such that when the plug portion is moved proximally into the internal cavity, the plug portion is compressed within the internal cavity thereby creating the inward radial force that seals the slit.

11. The catheter assembly of claim 10, wherein the inner lumen of the catheter adapter has a circular cross-sectional area.

12. The catheter assembly of claim 9, wherein, when in the collapsed state, less than 50% of the length of the slit extends distally from the distal end of the tube portion.

13. The catheter assembly of claim 9, wherein the internal cavity has a first cross sectional area, taken perpendicular to a central axis of the tube portion, that is smaller than a second cross-sectional area of the plug portion, taken perpendicular to the central axis of the tube portion at a location distal from the distal end of the tube portion.

14. The catheter assembly of claim 9, wherein the septum transitions from the non-collapsed state to the collapsed state in response to a pressure on a distal face of the septum exceeding a threshold pressure.

15. The catheter assembly of claim 14, wherein the threshold pressure is greater than a pressure produced by withdrawing an introducer needle through the slit.

16. The catheter assembly of claim 9, further comprising one or more holes disposed through the catheter adapter between the inner lumen of the catheter adapter and the external environment, the one or more holes being disposed at one or more locations along the inner lumen that are covered by the septum when in the non-collapsed state and that are uncovered by the septum when in the non-collapsed state.

17. A method of sealing a catheter assembly, the method comprising:

providing a catheter assembly having a catheter adapter, a catheter, and a septum, the septum being disposed in a non-collapsed state within the catheter adapter, the catheter assembly further having an introducer needle extending through the septum, wherein the septum includes a tube portion forming an internal cavity and a plug portion coupled to a distal end of the tube portion, the plug portion having a slit extending therethrough, the slit having a slit length, the septum being movable from the non-collapsed state, in which some of the length of the slit extends distally from the distal end of the tube portion, to a collapsed state, in which the plug portion is moved proximally into the internal cavity such that less of the length of the slit extends distally from the distal end of the tube portion and such that, when in the collapsed state, the tube portion applies an inward radial force against the plug portion to thereby seal the slit to prevent a fluid from passing through the slit;

placing the catheter within a patient;

withdrawing the introducer needle from the catheter assembly while the septum remains in the non-collapsed state; and

infusing fluid into the catheter assembly, during which time the septum transitions from the non-collapsed state to the collapsed state in response to an increase in pressure within the catheter adapter.

18. The method of claim 17, wherein, one or more holes disposed through the catheter adapter between the inner lumen of the catheter adapter and the external environment are exposed when the septum transitions to the collapsed state.