Resealable access site

• US 6,162,206 A
• Filed: 12/23/1997
• Issued: 12/19/2000
• Est. Priority Date: 12/23/1997
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Scharf, Michael W., Forman, Hugh M., Rudolph, Daniel J., Stonis, Thomas A., Brausam, Ray, Bacehowski, David V., Lal, Birendra K., Jepson, Steven C., Ling, Michael T. K., Bindokas, Algirdas J.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): Cho, David J.
• Application Number:
  US08/996,642
• Time in Patent Office: 1,092 Days
• Field of Search: 604/167, 604/169, 604/170, 604/256, 604/283, 604/414, 604/415, 604/416, 604/905, 604/533, 604/534, 604/535, 604/536, 604/539, 251/149.1
• US Class Current: 604/533
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

A resealable access site (10) is provided for allowing a cannula (18) multiple accesses to an internal cavity (35) defined by a container (12). The access site (10) includes a first conduit (28) defining a passageway (29) forming a fluid path to the cavity within the container. Sealingly attached to the conduit (28) is a housing (26) with a lower portion (26a) and a lower flange (68) attached to a lower end of the lower portion and extending radially inward from the lower portion. A septum (24) is disposed and compressed within the lower portion, with the septum defining an opening (46) extending upward through at least a portion of the septum. The opening (46) is sized for insertion of the cannula (18) through the septum (24) with the septum sealing about the exterior of the cannula. The septum (24) is maintained in the housing by the support provided by the opposing flange (68) and conduit (28).

Claims

1. An access site for allowing a cannula multiple accesses to a fluid passageway, the site comprising;

a first generally flexible conduit having a lower portion defining the passageway, a lower end of the lower portion forming a ring shaped land area;

a housing including a lower portion having an upward extending inner surface, a radially extending flange attached to a lower end of the lower portion and extending inward from the lower portion, the housing also including an upper portion, the lower portion of the first conduit being sealingly attached to the upper portion; and

a septum compressingly disposed within the lower portion of the housing, the septum defining an opening extending upward through at least a portion of the septum, the opening sized for sealed insertion of the cannula through the septum, the septum having an upper surface with an upper outer circumferential edge portion and a lower surface with a lower outer circumferential edge portion, the conduit being connected to the housing so that the ring shaped land area is immediately adjacent the upper outer circumferential edge portion of the septum to support the septum against displacement upward upon insertion of the cannula and the radial flange extending over the lower outer circumfernetial edge portion to define a target access opening to the septum.

2. The access site of claim 1 wherein an inner surface of the lower portion of the housing is formed as a cylinder having a constant radius about an axis defined by at least the lower portion of the housing.

3. The access site of claim 1 wherein the upper portion of the housing forms a tapered inner surface.

4. The access site of claim 3 wherein the tapered inner surface extends to the inner surface of the lower portion of the housing.

5. The access site of claim 1 wherein the housing includes a thickened upper end portion.

6. The access site of claim 5 wherein the outer wall of the housing below the thickened upper end portion is cylindrical.

7. The access site of claim 1 wherein the lower radial flange includes a tapered inner edge portion.

8. The access site of claim 1 wherein the land area is in abutting contact with the upper edge portion of the septum.

9. The access site of claim 8 wherein the land area is generally flat and radially extending.

10. The access site of claim 9 wherein the upper edge portion is generally flat and radially extending.

11. The access site of claim 1 wherein the conduit is in fluid communication with a flexible container, the container is formed with a port tube, the port tube being sealingly attached to the conduit.

12. The access site of claim 1 wherein the lower radial flange includes a tapered inner edge portion, the inner edge portion having an inner edge defining the target opening, the septum including a raised dome portion extending downward into the target opening.

13. The access site of claim 12 wherein the upper surface of the septum forms a generally concave shaped void.

14. The access site of claim 1 wherein the septum includes an upper layer and a lower portion attached to the upper layer, the upper layer being composed of a different material than the lower layer.

15. The access site of claim 14 wherein the opening extends only within the lower portion of the septum.

16. The access site of claim 1 wherein the septum is bonded to the housing.

17. The access site of claim 1 further including a barrier layer disposed in close proximity to the septum.

18. The access site of claim 17 wherein the barrier layer forms an upper layer on the septum.

19. The access site of claim 17 wherein the barrier layer is bonded to the septum.

20. The access site of claim 17 wherein the barrier layer is deposited on the upper surface of the septum by flashing off solvent contained within a solution including the solvent and a material forming the barrier layer.

21. The access site of claim 17 wherein the barrier layer is attached to the housing in close proximity to the septum.