SYSTEMS AND METHODS FOR PROVIDING A FLUSHABLE CATHETER ASSEMBLY

• US 20100204648A1
• Filed: 02/10/2010
• Published: 08/12/2010
• Est. Priority Date: 02/11/2009
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Isaacson, S. Ray, McKinnon, Austin Jason, Stout, Marty L., Harding, Weston F.
• Granted Patent: US 8,469,928 B2
• Time in Patent Office: Days
• US Class Current: 604/122
• 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 2039/062 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 2205/0238 the material being a coating or protective layer
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• 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 39/26 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 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 a perimeter selected to permit passage of at least one of air and blood at a desired rate of flow; and

an introducer needle having a first end and a second end, the first end being coupled to the needle hub and the second 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, 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.

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 3, 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.

5. The system of claim 3, 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.

6. The system of claim 2, 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.

22. The vascular access device of claim 1, wherein said pusher is movable along said first lumen from a proximal position to a distal position.

23. The vascular access device of claim 1, wherein said second fluidic seal prevents passage of a fluid between said outer surface of said pusher and said inner surface of said first lumen.

24. The vascular access device of claim 1, wherein a fluid is permitted to flow between said proximal and distal portions of said first lumen via said conduit.

25. The vascular access device of claim 1, wherein said second fluidic seal comprises a sleeve disposed over an outer surface of said pusher.

26. The medical device of claim 1, wherein said vascular access device is a catheter.

27. The medical device of claim 1, further comprises an interstitial space interposed between said outer surface of pusher and said inner wall surface of said first lumen, said second fluidic seal preventing passage of a said fluid into said interstitial space.

29. The vascular access device of claim 7, wherein said pusher is movable along said first lumen from a proximal position to a distal position.

8. 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;

interposedly positioning 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 a perimeter selected to permit passage of at least one of air and blood at a desired rate of flow; and

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.

9. The method of claim 8, 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.

10. The method of claim 9, 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.

11. The method of claim 10, 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 10, 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. The method of claim 9, further comprising modifying the proximal surface of the septum to include a cavity for housing the distal end of the septum activator, wherein a distal surface of the septum is dome-shaped.

14. The method of claim 13, further comprising providing a relief 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.

30. The vascular access device of claim 8, wherein said distal end of said pusher is biased through said pathway of said septum when said pusher is in said distal position, said second lumen forming a conduit through said septum.

32. The vascular access device of claim 11, wherein said opening comprises a longitudinal slot.

33. The vascular access device of claim 11, wherein said pusher is movable along said proximal portion of said first lumen from a proximal position to a distal position.

34. The vascular access device of claim 13, wherein said membrane is positioned within said second lumen when said pusher is in said distal position.

35. The vascular access device of claim 14, wherein when said pusher is in said distal position, said vascular access device further comprises a fluid pathway consisting of said proximal portion of said first lumen, said second lumen, said gap of said actuating end, said opening of said sleeve member, said hollow interior of said sleeve member, and said distal portion of said first lumen.

36. The vascular access device of claim 12, wherein said opening comprises a plurality of longitudinal slots.

37. The vascular access device of claim 11, wherein said gap comprises a notch formed in the actuating end of said pusher.

38. The vascular access device of claim 11, wherein said gap comprises a plurality of gaps.

39. The vascular access device of claim 11, wherein said distal portion of said first lumen further includes a third inner diameter, said third inner diameter being smaller than said first inner diameter.

15. 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, 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 catheter adapter, 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;

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.

16. The assembly of claim 15, 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.

17. The assembly of claim 15, 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.

18. The assembly of claim 15, 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.

19. The system of claim 18, 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.

20. The system of claim 15, further comprising an antimicrobial coating applied to at least one of the catheter adapter, the septum, the ventilation channel, the introducer needle, the septum activator and the external device.

40. The vascular access device of claim 19, wherein said first inner diameter comprises an annular recess in said third inner diameter, said annular recess preventing relocation of said septum in a distal direction.

21. A vascular access device comprising:

a body having a first lumen extending therethrough;

a septum disposed within said first lumen thereby dividing the first lumen into a proximal portion and a distal portion, the septum forming a first fluidic seal between the proximal and distal portions, the septum further having a defeatable valve interposed between the proximal and distal portions;

a pusher disposed within the proximal portion of the first lumen, a second fluidic seal interposed between an outer surface of the pusher and an inner wall surface of the first lumen, the pusher further having a proximal end, a distal end, and a second lumen extending therebetween, wherein fluid communication is provided between the proximal and distal portions by advancing the distal end of the pusher through the defeatable valve such that the second lumen provides a conduit between the proximal and distal portions of the first lumen.

28. A vascular access device comprising:

a body including a first lumen extending therethrough; and

a flow control valve disposed within said first lumen, said flow control valve comprising a septum having a pathway, a pusher disposed within said first lumen in proximity to said septum, said pusher having a distal end, a proximal end, and a second lumen therethrough, said pusher further having a seal attached to an outer surface of said pusher, said seal forming a fluidic seal between said outer surface of said pusher and an inner surface of said first lumen, wherein said first lumen and said second lumen are in substantially coaxial alignment and said seal is interposed between said first and second lumen to form said fluidic seal.

31. A vascular access device comprising:

a body including a first lumen extending therethrough, a distal portion of the first lumen having a first inner diameter and a proximal portion of the first lumen having a second inner diameter, the second inner diameter being greater than the first inner diameter;

a septum having a proximal end and a distal end, said proximal end being positioned entirely within said proximal portion of said lumen and said distal end being partially positioned within said proximal portion of said first lumen and partially disposed within said distal portion of said first lumen, said proximal end including a membrane having an outer diameter approximately equal to the second inner diameter, said membrane forming a first fluidic seal between said body and said septum, said distal end of said septum including a sleeve member having an outer diameter approximately equal to said first inner diameter, said sleeve member having a hollow interior in fluid communication with said distal portion of said first lumen, said sleeve member further including an opening whereby the hollow interior is in fluid communication with an enclosed portion of the proximal portion of the first lumen, said enclosed portion defining a space interposed between said flange and said distal portion of said first lumen;

a pusher having a contact end, an actuating end, and a second lumen extending therethrough, said pusher having an outer diameter approximately equal to said second inner diameter, said pusher forming a second fluidic seal between said body and said pusher;

an interface formed between a surface of said flange and said actuating end of said pusher; and

a gap interposed between said surface of said flange and said actuating end of said pusher.