One piece low drag septum

• US 7,670,317 B2
• Filed: 10/25/2005
• Issued: 03/02/2010
• Est. Priority Date: 10/25/2005
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Brimhall, Greg L., Cindrich, Chris
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): KOHARSKI, CHRISTOPHER
• Application Number:
  US11/258,560
• Publication Number:
  US 20070093778A1
• Time in Patent Office: 1,589 Days
• Field of Search: 604/256, 604/195, 604/167.01, 604/167.02, 604/167.03, 604/167.04, 604/167.06, 604/533, 604/536
• US Class Current: 604/167.01
• 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 2039/0646 Duckbill-valve
• CPC Class Codes: A61M 2039/066 Septum-like element
• 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 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/3273 freely sliding on needle shaft without connection to syringe or needle

Abstract

A one-piece low drag septum is provided for preventing escape of fluid from an introducer needle during removal of such a needle from a catheter and introducer needle assembly. The septum generally includes a distal portion, a proximal portion, a cavity portion, and a longitudinal axis. The distal portion acts as a primary seal to prevent escape of blood from the catheter into the assembly and is generally positioned furthest away from the user of the apparatus and nearest the patient. The cavity portion reduces friction placed on the introducer needle. The proximal portion of the septum acts as a secondary seal to prevent escape of material from the cavity, seals the cavity, and wipes the needle as it is being withdrawn from the catheter assembly.

Claims

1. A septum assembly for providing a seal about a needle and for sealing closed when the needle is withdrawn, the septum assembly comprising:

a septum housing;

a one-piece septum inserted within the septum housing, the septum having a longitudinal axis, a distal portion, a distal outlet, a proximal portion, a proximal outlet, and a cavity portion disposed between the distal portion and the proximal portion wherein the proximal portion of the one-piece septum comprises at least two flared regions extending outwardly away from an outer diameter of the proximal portion of the septum such that when the septum is placed within the housing the housing exerts a compressive force on the flared regions sealing the proximal outlet; and

wherein the distal end of the septum includes a slit substantially sealing the distal outlet.

2. The septum assembly of claim 1, wherein the cavity portion extends completely through the proximal portion of the septum.

3. The septum assembly of claim 1, wherein the at least two flared regions extends away from an outer diameter of the proximal portion of the septum along substantially all of the outer diameter of the proximal portion of the septum.

4. A needle-sealing assembly comprising:

a needle having a proximal end, a distal end with an opening, and an outer diameter;

a housing having a predetermined shape, the needle being disposed within the housing;

a one-piece seal disposed within the housing about the needle and having a longitudinal axis, a distal portion, a proximal portion, and a cavity portion, the cavity portion extending between the proximal portion and the distal portion and having an inner diameter greater than or equal to the outer diameter of the needle, wherein the cross section of the cavity portion seals a proximal outlet and a distal outlet of the one piece seal when the needle is withdrawn from the one-piece seal wherein the proximal portion of the one-piece septum comprises two flared regions extending outwardly away from an outer diameter of the proximal portion of the septum such that when the septum is placed within the housing the housing exerts a compressive force on the flared regions sealing the proximal outlet, wherein the two flared regions are positioned substantially opposite each other on the outer diameter of the proximal portion of the seal.

5. A method of sealing a catheter adapter during the storage, use, and removal of a needle projecting therethrough, the method comprising the steps of:

providing a catheter adapter having a housing and including an introducer needle extending therethrough, the needle having a proximal end, and a distal end with bore;

providing a one-piece elastomeric septum disposed about the needle and positioned within the housing, the septum having a cavity portion provided between a proximal septum portion and a distal septum portion of the septum, the cavity portion having an inner diameter greater than or equal to the outer diameter of the needle wherein the proximal portion of the one-piece septum comprises at least two flared regions extending outwardly away from an outer diameter of the proximal portion of the septum such that when the septum is placed within the housing the housing exerts a compressive force on the flared regions sealing the proximal outlet, wherein the two flared regions are positioned substantially opposite each other on the outer diameter of the proximal portion of the seal; and

wherein the cavity portion has a cross section that facilitates sealing of a proximal and distal outlet of the one piece elastomeric septum when the introducer needle is withdrawn from the catheter adapter.

6. The method of sealing a catheter adapter of claim 5, wherein the introducer needle further comprises a notch adjacent the opening of the distal end and a notch distance defined as the distance between the notch and a distal end of the opening in the distal end of the introducer needle, and wherein the septum has an overall length greater than the notch distance.