Venous access port assembly with X-ray discernable indicia

• US 8,021,324 B2
• Filed: 07/17/2008
• Issued: 09/20/2011
• Est. Priority Date: 07/19/2007
• Status: Active Grant

• Current Assignee: Medical Components, Inc.
• Original Assignee: Medical Components, Inc.
• Inventors: Linden, Christopher, Bizup, Raymond, Sanford, Kevin
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US12/175,182
• Publication Number:
  US 20090024098A1
• Time in Patent Office: 1,160 Days
• Field of Search: 60428801-28804, 604/86, 604/88, 604/116, 604/167.02
• US Class Current: 604/88
• CPC Class Codes: A61M 2039/0009 Assemblies therefor designed for particular applications, e.g. contrast or saline injection, suction or irrigation
• CPC Class Codes: A61M 2039/0045 Radiopaque indicia
• CPC Class Codes: A61M 2039/0205 for injecting media
• CPC Class Codes: A61M 2039/0238 having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• 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 39/04 having pierceable self-sealing members

Abstract

A venous access port assembly (10) having a housing base (28) with a discharge port (16), a septum (14) and a cap (48), with an interior reservoir (22). The housing base (28) is provided with X-ray discernable indicia (100,200) to identify an attribute of the assembly (10) after its implantation and clearly appear on an X-ray of the patient in a manner informing the radiologist or technologist and the medical practitioner of that particular attribute. Such indicia can be depicted as cutouts (102) through a disc of radiopaque material (100) where the cutouts are in the form of alphabetical letters such as “CT”, or can be a set (200) of discrete elements (202) of radiopaque material, that are affixed along the bottom surface of the housing base or embedded within the thickness of the bottom housing wall.

Claims

1. An implantable venous access port assembly, comprising:

a needle-penetrable septum; and

a housing securing the needle-penetrable septum, the housing comprising a housing base having a bottom wall and X-ray discernable indicia embedded in the bottom wall, the X-ray discernable indicia comprising one or more characters that visually indicate, under X-ray examination, a pressure property of the port assembly.

2. The assembly of claim 1, wherein the X-ray discernable indicia are a set of discrete elements.

3. The assembly of claim 2, wherein the discrete elements are of titanium.

4. The assembly of claim 2, wherein the discrete elements are of silicone with barium sulfate filler.

5. The assembly of claim 2, wherein the discrete elements are alphabetical letters.

6. The assembly of claim 2, wherein the bottom wall comprises an outwardly facing bottom surface comprising one or more shallow recesses, and wherein the discrete elements are affixed in the one or more shallow recesses of the bottom surface so that the discrete elements are visible to an unaided eye prior to implantation of the assembly.

7. The assembly of claim 2, wherein the discrete elements embedded in the bottom wall are embedded within a thickness of the bottom wall so that the discrete elements are not visible to an unaided eye prior to implantation of the assembly.

8. The assembly of claim 6, wherein the discrete elements are arranged in a first orientation visible under visual inspection of the port assembly, which first orientation is a mirror image of a second orientation of an image of the discrete elements perceived during X-ray examination.

9. The assembly of claim 6, wherein the housing comprises a skirt formed from radiotransparent material and molded around at least a portion of the housing base.

10. The assembly of claim 1, wherein the X-ray discernable indicia comprise a disc of radiopaque material, the disc comprising cutouts that indicate the pressure property of the port assembly.

11. The assembly of claim 10, wherein the cutouts are alphabetical letters.

12. The assembly of claim 10, wherein the disc is titanium.

13. The assembly of claim 10, wherein the bottom wall comprises an outwardly facing bottom surface comprising at least one shallow recess, and wherein the disc is affixed in the at least one shallow recess of the bottom surface so that the disc is visible to an unaided eye prior to implantation of the assembly.

14. The assembly of claim 10, wherein the disc embedded in the bottom wall is embedded within a thickness of the bottom wall so that the disc is not visible to an unaided eye prior to implantation of the assembly.

15. The assembly of claim 13, wherein the cutouts in the disc are arranged in a first orientation visible under visual inspection of the port assembly, which first orientation is a mirror image of a second orientation of an image of the cutouts perceived during X-ray examination.

16. The assembly of claim 13, wherein the housing comprises a skirt formed from radiotransparent material and molded around at least a portion of the housing base.

17. The assembly of claim 1, wherein the X-ray discernable indicia visually indicate, under X-ray examination, that the port assembly is rated to be used for power injection.

18. The assembly of claim 17, wherein the X-ray discernable indicia further visually indicate, under X-ray examination, that the port assembly is adapted to withstand high pressures used for injection of contrast fluid.

39. The assembly of claim 1, wherein the one or more characters comprise one or more alphabetical letters.

40. The assembly of claim 39, wherein the one or more alphabetical letters comprise the letters “

CT.”

19. An implantable venous access port assembly, comprising:

a housing comprising a housing base comprising a bottom wall and radiopaque indicia embedded in the bottom wall of the housing base, the radiopaque indicia comprising one or more characters indicating a pressure property of the port assembly under X-ray examination;

a needle-penetrable septum; and

a cap securing the needle-penetrable septum to the housing.

20. The port assembly of claim 19, wherein:

the bottom wall of the housing base comprises a bottom surface comprising one or more shallow recesses, and

the radiopaque indicia are affixed in the one or more shallow recesses of the bottom surface of the bottom wall, whereby the radiopaque indicia are visible by an unaided eye prior to implantation of the port assembly.

21. The port assembly of claim 20, wherein the radiopaque indicia comprise a metal disc affixed in the one or more shallow recesses of the bottom surface of the bottom wall, the metal disc comprising one or more cutouts indicating the pressure property of the port assembly.

22. The port assembly of claim 20, wherein the radiopaque indicia comprise one or more discrete metal elements separately affixed in the one or more shallow recesses of the bottom surface of the bottom wall.

23. The port assembly of claim 19, wherein the radiopaque indicia are embedded into a thickness of the bottom wall of the housing base, whereby the radiopaque indicia are not visible by an unaided eye prior to implantation of the port assembly.

24. The port assembly of claim 23, wherein the radiopaque indicia comprise a metal disc embedded into the thickness of the bottom wall of the housing base, the metal disc comprising one or more cutouts indicating the pressure property of the port assembly.

25. The port assembly of claim 23, wherein the radiopaque indicia comprise one or more discrete metal elements separately embedded into the thickness of the bottom wall of the housing base.

26. The port assembly of claim 19, wherein the radiopaque indicia indicate that the port assembly is rated to be used for power injection.

27. The port assembly of claim 26, wherein the radiopaque indicia indicate that the port assembly is adapted to withstand high pressures used for injection of contrast fluid.

41. The port assembly of claim 19, wherein the one or more characters comprise one or more alphabetical letters.

42. The port assembly of claim 41, wherein the one or more alphabetical letters comprise the letters “

CT.”

28. An implantable venous access port assembly, comprising:

a housing comprising a housing base and a skirt overmolded around at least a portion of the housing base, the housing base comprising a bottom wall and radiopaque indicia embedded in the bottom wall of the housing base, the radiopaque indicia comprising one or more characters indicating a pressure property of the port assembly under X-ray examination;

a needle-penetrable septum; and

a cap securing the needle-penetrable septum to the housing.

29. The port assembly of claim 28, wherein:

the bottom wall of the housing base comprises a bottom surface comprising one or more shallow recesses, and

the radiopaque indicia are affixed in the one or more shallow recesses of the bottom surface of the bottom wall.

30. The port assembly of claim 29, wherein the radiopaque indicia comprise a metal disc affixed in the one or more shallow recesses of the bottom surface of the bottom wall, the metal disc comprising one or more cutouts indicating the pressure property of the port assembly.

31. The port assembly of claim 30, wherein the overmolded skirt comprises a transparent material, whereby the metal disc comprising one or more cutouts is visible by an unaided eye prior to implantation of the port assembly.

32. The port assembly of claim 29, wherein the radiopaque indicia comprise one or more discrete metal elements separately affixed in the one or more shallow recesses of the bottom surface of the bottom wall.

33. The port assembly of claim 32, wherein the overmolded skirt comprises a transparent material, whereby the discrete metal elements are visible by an unaided eye prior to implantation of the port assembly.

34. The port assembly of claim 28, wherein the radiopaque indicia are embedded into a thickness of the bottom wall of the housing base, whereby the radiopaque indicia are not visible by an unaided eye prior to implantation of the port assembly.

35. The port assembly of claim 34, wherein the radiopaque indicia comprise a metal disc embedded into the thickness of the bottom wall of the housing base, the metal disc comprising one or more cutouts indicating the pressure property of the port assembly.

36. The port assembly of claim 34, wherein the radiopaque indicia comprise one or more discrete metal elements separately embedded into the thickness of the bottom wall of the housing base.

37. The port assembly of claim 28, wherein the radiopaque indicia indicate that the port assembly is rated to be used for power injection.

38. The port assembly of claim 37, wherein the radiopaque indicia indicate that the port assembly is adapted to withstand high pressures used for injection of contrast fluid.

43. The port assembly of claim 28, wherein the one or more characters comprise one or more alphabetical letters.

44. The port assembly of claim 43, wherein the one or more alphabetical letters comprise the letters “

CT.”