Access portal and method

• US 5,989,216 A
• Filed: 06/25/1996
• Issued: 11/23/1999
• Est. Priority Date: 06/29/1995
• Status: Expired due to Fees

• Current Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Original Assignee: Sims Deltec, Inc.
• Inventors: Johnson, Theodore A., Puryear, Harry A.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/670,006
• Time in Patent Office: 1,246 Days
• Field of Search: 604/93, 604/256, 604/175, 604/905
• US Class Current: 604/288.02
• CPC Class Codes: A61M 2039/0072 Means for increasing tightness of the septum, e.g. compression rings, special materials, special constructions
• 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: Y10S 604/905 Aseptic connectors or couplings, e.g. frangible, piercable

Abstract

The present invention provides a portal for subcutaneous implantation, where the portal includes a housing having a first end, a second end, an inner wall, and a lumen between the first and second open ends. In one preferred embodiment, the first open end of the housing is sealed by a elastomeric septum, which has been injection molding into place. The elastomeric septum is bonded to the inner wall of the housing adjacent the first open end. The second open end is sealed to define a reservoir accessible through the septum.

Claims

1. A portal for subcutaneous implantation comprising:

a housing having a lumen accessible through a first open end;

the lumen including an inner wall, the inner wall having an adhesion promoter thereon adjacent the first open end, said lumen having a longitudinal axis; and

a cured in place elastomeric septum having an outer periphery bonded to the inner wall adjacent the first open end of the housing said septum cured in place by injection molding said septum into said open end, said septum having a vertical dimension in the direction of said longitudinal axis and being axially, non-compressively held within said lumen along at least a first portion of said vertical dimension.

2. The portal of claim 1, wherein the septum includes a bottom surface facing the lumen, the bottom surface being undulated in shape.

3. The portal of claim 1, wherein said spetum is axially, non-compressively held along its entire vertical dimension.

4. The portal of claim 1, wherein the inner wall of the housing adjacent the first open end includes a roughened surface.

5. The portal of claim 1, wherein the inner wall of the housing adjacent the first open end includes a groove.

6. The portal of claim 1, wherein the septum is silicone and the adhesion promoter includes silane.

7. The portal of claim 1, wherein the housing further includes an outlet tube assembly operative in accessing the lumen.

8. The portal of claim 7, wherein the housing further includes a second open end opposite from the first open end;

the second open end including an associated diameter;

the portal further comprising a seal operative to close the second open end of the housing.

9. The portal of claim 8, wherein the seal comprises a cup-shaped insert.

10. The portal of claim 9, wherein the cup-shaped insert has an associated outer diameter larger than the associated diameter of the second open end of the housing, the cup-shaped inserted being forced into the second end of the housing to provide an interference fit between the housing and the cup-shaped insert.

11. The portal of claim 9, wherein the cup-shaped insert is ultrasonically staked to the housing.

12. The portal of claim 9, wherein the septum includes a flanged region along a second portion of said vertical dimension, and wherein the cup-shaped insert squeezably engages the flanged region.

13. The portal of claim 9, wherein the cup-shaped insert is spaced from the septum at a peripheral edge of the cup-shaped insert.

14. The portal of claim 8, wherein the seal is metallic.

15. The portal of claim 14, wherein the housing is metallic.

16. The portal of claim 8, wherein the seal is a planar.

17. The portal of claim 16, wherein the seal is a disc.

18. The portal of claim 17, wherein the disc is bonded to the housing adjacent the second end with adhesives.

19. The portal of claim 7, wherein the housing is non-metallic.

20. The portal of claim 19, wherein the housing is polysulfone.

21. A portal for subcutaneous implantation, the portal comprising:

a housing having a first open end and a second end having a lumen therebetween, the lumen including an inner wall;

an elastomeric septum positioned in the lumen of the housing against the inner wall adjacent the first open end of the housing, the septum having an outer periphery; and

a planar member sealing the second end of the housing so as to define a sealed reservoir accessible through the septum, said planar member having a planar dimension not significantly larger than that of said second end, said planar member spaced from said outer periphery of said septum, wherein an air space is defined between said planar member and said outer periphery of said septum.

22. The portal of claim 21, wherein the housing further includes an outlet tube assembly operative in accessing the sealed reservoir.

23. The portal of claim 22, wherein the housing is ultransonically staked to the planar member.

24. The portal of claim 23, wherein the housing further includes an annular lip extending from the housing adjacent the second end, the lip folded over the planar member as to create a sealed reservoir.

25. The portal of claim 21, wherein the elastomeric septum is injection molded.

26. The portal of claim 21, wherein the planar member is a disc.

27. A portal for subcutaneous implantation comprising:

a housing having a first open end, and a lumen therebetween, a portion of the lumen having an adhesion promoter thereon adjacent the first open end;

a cured in place silicone septum sealing the first open end wherein the septum is injection molded into the first open end at the location of the adhesion promoter so as to be integrally formed with said lumen; and

means for sealing the second open end.

28. The portal of claim 27, wherein the means for sealing includes a cup-shaped insert.

29. The portal of claim 27, wherein the means for sealing includes a disc.

30. The portal of claim 27, wherein the means for sealing forceably engages the septum.

31. The portal of claim 30, wherein the means for sealing includes a cup-shaped insert.

32. The portal of claim 27, wherein the septum has an undulated surface facing the lumen.

33. The portal of claim 27, wherein the septum includes a side surface, and the housing includes a groove adjacent to the side surface of the septum.

34. A portal for subcutaneous implantation comprising:

a silicone septum with first and second opposite surfaces, the second surface being undulated, the septum having a side surface;

an insert engaging the septum, the second surface of the septum facing the insert;

a housing holding the septum and the insert; and

an adhesion promoter between the side surface of the septum and the housing, wherein the septum includes a flanged region and a non-flanged region along the side surface of the septum, and the insert forcibly squeezes the flanged region but not the non-flanged region, and wherein the septum is injection molded into the housing so as to be integrally formed with said lumen.

35. The portal of claim 34, wherein the insert includes an annular recess, and the housing is ultrasonically staked in to the recess.

36. The portal of claim 34, wherein the housing includes a groove adjacent to the side surface of the septum.