One piece low drag septum

• US 20070093778A1
• Filed: 10/25/2005
• Published: 04/26/2007
• Est. Priority Date: 10/25/2005
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Cindrich, Chris, Brimhall, Greg
• Granted Patent: US 7,670,317 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• 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a secondary seal to prevent escape of material from the cavity, seals the cavity, and wipes the needle as it is being withdrawn from the catheter assembly.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 A septum assembly for providing a seal about a needle and for sealing closed when the needle is withdrawn, the septum assembly comprising: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; and

a one-piece septum inserted within the septum housing, the septum having a longitudinal axis, a distal portion, a proximal portion, and a cavity.

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

3. The septum assembly of claim 2, wherein the proximal portion of the one-piece septum comprises at least one flared region extending outwardly away from an outer diameter of the proximal portion of the septum.

4. The septum assembly of claim 3, wherein the proximal portion of the one-piece septum includes two flared portions positioned substantially opposite each other on the outer diameter of the proximal portion of the septum.

5. The septum assembly of claim 3, wherein the flared region 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.

6. The septum assembly of claim 2, wherein the proximal portion of the septum comprises an elongated sheath surrounding a proximal portion of the cavity, the proximal portion of the cavity having an inside diameter equal to or slightly smaller than an outer diameter of the needle.

7. The septum assembly of claim 1, wherein the cavity does not extend completely through either the proximal end or the distal end of the septum.

8. The septum assembly of claim 7, wherein the cavity extends completely through a first lateral wall of the septum and the longitudinal axis of the septum between its proximal and distal ends.

9. The septum assembly of claim 8, wherein the cavity extends completely through a first lateral wall of the septum and through a second opposing lateral wall of the septum between the proximal and distal ends of the septum.

10. The septum assembly of claim 7, wherein the cavity portion extends into either or both the proximal and distal septum portions.

11. The septum assembly of claim 1, wherein the septum comprises a longitudinally-hinged segment that are assembled in clamshell fashion to form the septum.

12. 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; and

a one-piece means for sealing the housing, the sealing means being disposed within the housing about the needle and having a longitudinal axis, a distal portion, a proximal portion, and a cavity, the cavity of the sealing means 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 sealing means provides a seal about the needle while the needle is in place and a closed seal upon removal of the needle.

13. The needle-sealing assembly of claim 12, wherein the cavity extends completely through the proximal portion of the sealing means and the proximal portion of the sealing means comprises at least one flared region extending outwardly away from an outer diameter of the proximal portion of the sealing means.

14. The needle-sealing assembly of claim 13, wherein the proximal portion of the sealing means includes two flared portions positioned substantially opposite each other on the outer diameter of the proximal portion of the sealing means.

15. The needle-sealing assembly of claim 12, wherein the cavity extends completely through the proximal portion of the sealing means and the proximal portion of the sealing means comprises an elongated sheath surrounding a proximal portion of the cavity, the proximal portion of the cavity having an inside diameter slightly smaller than an outer diameter of the needle.

16. The needle-sealing assembly of claim 12, wherein the cavity extends completely through a first lateral wall of the sealing means and the longitudinal axis of the sealing means between its proximal and distal ends.

17. The needle-sealing assembly of claim 16, wherein the cavity extends completely through a first lateral wall of the sealing means and through a second opposing lateral wall of the sealing means between the proximal and distal ends of the sealing means.

18. The needle-sealing assembly of claim 12, wherein the cavity portion extends into either or both the proximal and distal sealing means portions.

19. The needle-sealing assembly of claim 12, wherein the sealing means comprises at least two longitudinally-hinged segments that are assembled about the needle in clamshell fashion to form the sealing means.

20. 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 including an introducer needle extending therethrough, the needle having a proximal end, and a distal end with bore; and

providing a one-piece elastomeric septum disposed about the needle and positioned within the catheter adapter, the septum having a cavity provided between a proximal septum portion and a distal septum portion of the septum, the cavity having an inner diameter greater than or equal to the outer diameter of the needle;

wherein the septum conforms its shape to the dimensions of the needle during storage and use of the catheter adapter, and wherein the septum seals closed upon withdrawal of the needle.

21. The method of sealing a catheter adapter of claim 20, wherein the proximal portion of the one-piece elastomeric septum comprises at least one flared region extending outwardly away from an outer diameter of the proximal portion of the septum.

22. The method of sealing a catheter adapter of claim 20, wherein the proximal portion of the septum comprises an elongated sheath surrounding a proximal portion of the cavity, the proximal portion of the cavity having an inside diameter slightly smaller than an outer diameter of the needle.

23. The method of sealing a catheter adapter of claim 20, wherein the cavity extends completely through a first lateral wall of the septum and through a longitudinal axis of the septum between the proximal end and the distal end of the septum.

24. The method of sealing a catheter adapter of claim 20, wherein the cavity extends into either or both the proximal and distal septum portions.

25. The method of sealing a catheter adapter of claim 20, wherein the septum comprises a longitudinally-hinged segment that are assembled about the needle in clamshell fashion to form the septum and are held together in a sealed manner about the needle by compression within the catheter adapter.

26. The method of sealing a catheter adapter of claim 20, 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.