Systems and methods for providing a catheter assembly

• US 8,679,063 B2
• Filed: 03/07/2011
• Issued: 03/25/2014
• Est. Priority Date: 02/11/2009
• Status: Expired

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Stout, Marty L., Harding, Weston F., Isaacson, S. Ray, Ma, Yiping, McKinnon, Austin Jason
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US13/042,154
• Publication Number:
  US 20110160663A1
• Time in Patent Office: 1,114 Days
• Field of Search: 604/164.01, 604/164.02, 60416701-16706, 604/168.01, 604244-246
• US Class Current: 604/164.01
• 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 2039/0646 Duckbill-valve
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• 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 25/0693 Flashback chambers
• 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 29/49982 Coating

Abstract

A system for controlling fluid flow in a catheter assembly is disclosed herein. An intravenous catheter assembly has a catheter adapter and a needle hub, and the catheter adapter has an inner lumen. A septum is disposed within a portion of the inner lumen, and a slit is formed through the septum. A Parylene coating is disposed within the slit of the septum, the Parylene coating has a thickness of between approximately 0.00005 to 0.0005 millimeters. An introducer needle has a first end coupled to the needle hub and the second end extending through the inner lumen of the catheter adapter. A middle portion of the introducer needle is positioned within a portion of the septum.

Claims

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

an intravenous catheter assembly having a catheter adapter and a needle hub, the catheter adapter having an inner lumen;

a septum disposed within a portion of the inner lumen;

a ventilation channel interposed between the septum and an inner surface of the inner lumen of the catheter adapter, the ventilation channel having a surface area and perimeter selected to permit passage of air and prevent passage of blood;

a slit formed through the septum;

a coating, formed of vapor deposited polyxylylene polymers, disposed within the slit of the septum, the coating having a thickness of between approximately 0.00005 to 0.0005 millimeters; and

an introducer needle having a first end and a second end, the first end being coupled to the needle hub and the second end extending through the inner lumen of the catheter adapter, a middle portion of the introducer needle being positioned within a portion of the septum.

2. The system of claim 1, wherein the thickness of the coating is between 0.0001 to 0.0002 millimeters.

3. The system of claim 2, further comprising a lumen forming a fluid pathway through the septum activator, the lumen having an inner diameter configured to permit passage of the introducer needle.

4. The system of claim 1, further comprising a septum activator disposed within a portion of the inner lumen adjacent to the septum, a distal end of the septum activator contacting a proximal surface of the septum, and a proximal end of the septum activator being positioned adjacent to an opening of the catheter adapter, wherein the proximal end of the septum activator is accessed by inserting an external device into the opening of the catheter adapter.

5. The system of claim 1, wherein the septum activator comprises a plurality of vents and flow diverters configured to improve circulation of a 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.

6. The system of claim 1, further comprising a flow vent interposed between an outer surface of the introducer needle and an inner surface of the septum activator lumen, wherein a rate of flow through the flow vent is determined by adjusting at least one of an outer diameter of the introducer needle and the inner diameter of the septum activator lumen.

7. A method manufacturing a catheter assembly having features for controlling fluid flow within the catheter assembly, the method comprising:

providing an intravenous catheter assembly having a catheter adapter and a needle hub, the catheter adapter having an inner lumen;

disposing a septum within the inner lumen, the septum having a slit therethrough;

providing a ventilation channel between the septum and an inner surface of the inner lumen of the catheter adapter, the ventilation channel having a surface area and perimeter selected to permit passage of air and prevent passage of blood;

coating the septum and the slit with a coating having a thickness of between approximately 0.00005 to 0.0005 millimeters, the coating being formed of vapor deposited polyxylylene polymers;

positioning an introducer needle within the catheter adapter, wherein a first end of the introducer needle is coupled to the needle hub and a second end of the introducer needle extends through the inner lumen of the catheter adapter, a middle portion of the introducer needle being positioned within a portion of the septum.

8. The method of claim 7, wherein the thickness of the coating is between 0.0001 to 0.0002 millimeters.

9. The method of claim 8, further comprising providing a lumen forming a fluid pathway through the septum activator, the lumen having an inner diameter configured to permit passage of the introducer needle.

10. The method of claim 7, further comprising disposing a septum activator within a portion of the inner lumen adjacent to the septum, a distal end of the septum activator contacting a proximal surface of the septum, and a proximal end of the septum activator being positioned adjacent to an opening of the catheter adapter, wherein the proximal end of the septum activator is accessed by inserting an external device into the opening of the catheter adapter.

11. The method of claim 7, further comprising modifying the septum activator to include a plurality of vents and flow diverters configured to improve circulation of a 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.

12. The method of claim 8, further comprising providing a flow vent interposed between an outer surface of the introducer needle and an inner surface of the septum activator lumen, wherein a rate of flow through the flow vent is determined by adjusting at least one of an outer diameter of the introducer needle and the diameter of the septum activator lumen.

13. An intravenous catheter assembly, comprising:

a catheter adapter 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;

a septum disposed within the recess, 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 catheter adapter, the ventilation channel having a surface area and perimeter selected to permit passage of air and prevent passage of blood;

a coating disposed within a slit of the septum, the coating having a thickness of between approximately 0.00005 to 0.0005 millimeters, the coating being formed of vapor deposited polyxylylene polymers;

an introducer needle positioned within the inner lumen, a portion of the needle extending through the inner lumen, such that a tip portion of the introducer needle extends beyond the catheter adapter, a portion of the introducer needle being inserted through the septum;

a septum activator positioned within the proximal end of the inner lumen, the septum activator having a pathway through which the introducer needle is inserted, the septum activator further having a first end for biasing open a slit of the septum, and a second end having a contact surface; and

an opening forming a proximal end of the catheter adapter, 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 and against the coating.

14. The assembly of claim 13, wherein the thickness of the coating is between 0.0001 to 0.0002 millimeters.

15. The assembly of claim 13, further comprising a flow vent interposed between an outer surface of the introducer needle and an inner surface of the septum activator pathway, wherein a rate of flow through the flow vent is determined by adjusting at least one of an outer diameter of the introducer needle and an inner diameter of the septum activator pathway.

16. 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 catheter adapter inner lumen.

17. 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.