Venous access port with molded and/or radiopaque indicia

• US 8,257,325 B2
• Filed: 06/20/2008
• Issued: 09/04/2012
• Est. Priority Date: 06/20/2007
• Status: Active Grant

• Current Assignee: Medical Components, Inc.
• Original Assignee: Innovative Medical Devices LLC, Medical Components, Inc.
• Inventors: Schweikert, Timothy M., Bizup, Raymond R., Zinn, Kenneth M., Sanford, Kevin E.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Thomas, Jr., Bradley
• Application Number:
  US12/143,377
• Publication Number:
  US 20080319399A1
• Time in Patent Office: 1,537 Days
• Field of Search: 604/891.1, 604/288.01, 604/288.02, 604/536, 604/175
• US Class Current: 604/288.01
• CPC Class Codes: A61M 2039/0205 for injecting media
• CPC Class Codes: A61M 2039/0229 having means for facilitating assembling, e.g. snap-fit housing or modular design
• 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 2205/32 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 5/007 for contrast media

Abstract

A venous access port assembly having a housing base with a discharge port, a septum and a cap. An interior reservoir is defined by a well in the housing base and a bottom of the septum, and a passageway extends from the reservoir through the discharge port. The housing base includes a base flange having integrally molded therein indicia identifying an attribute of the assembly. The indicia could be formed of base flange material, or could be formed by voids in the base flange material. If of plastic material, the molded indicia could be applied with a radiopaque agent, thereby allowing the indicia (“CT”) to appear on an X-ray of the patient in a manner informing a practitioner of a particular attribute of the assembly.

Claims

1. A venous access port assembly for implantation into a patient, comprising:

a housing comprising a base defining a bottom wall of at least one reservoir, a discharge port extending from the at least one reservoir, and a flange adjacent to the at least one reservoir, the flange comprising a height extending from a top surface of the flange to a bottom surface of the flange, the flange further comprising X-ray discernable indicia configured to indicate, under X-ray examination, that the port assembly is rated for power injection, the X-ray discernable indicia located in the flange and extending through the height of the flange from the top surface of the flange to the bottom surface of the flange so that the X-ray discernable indicia are visually discernable to a naked eye from both the top surface of the flange and the bottom surface of the flange prior to implantation of the port assembly; and

a needle-penetrable septum communicating with the housing.

2. The assembly of claim 1, wherein the X-ray discernable indicia comprise radiopaque markings.

3. The assembly of claim 2, wherein the radiopaque markings comprise radiopaque marking fluid.

4. The assembly of claim 3, wherein the fluid contains tungsten.

5. The assembly of claim 1, wherein the flange is comprised of a metal material, whereby the indicia are visible by X-ray examination when the assembly is subcutaneously implanted in a patient.

6. The assembly of claim 1, wherein the flange extends outwardly from the base about a perimeter of the at least one reservoir.

7. The assembly of claim 1, wherein the flange further includes suture openings, and the indicia are located within predetermined suture openings.

8. The assembly of claim 1, wherein the indicia comprise flange material.

9. The assembly of claim 1, wherein the indicia are voids in the flange.

10. The assembly of claim 1, wherein the assembly is at least partially comprised of radiotransparent material.

11. The assembly of claim 1, wherein the indicia indicate, under X-ray examination, that the assembly is adapted to withstand high pressures used for injection of contrast fluid.

12. An implantable venous access port assembly comprising:

a needle-penetrable septum;

a housing securing the needle-penetrable septum, the housing comprising a housing base defining at least one reservoir, and a flange extending radially from the housing base, the flange comprising;

X-ray discernable material;

a height extending from a top surface of the flange to a bottom surface of the flange; and

one or more cutouts extending entirely through the height of the flange from the top surface of the flange to the bottom surface of the flange, the one or more cutouts comprising one or more voids in the X-ray discernable material, the one or more cutouts configured to indicate, under X-ray examination, that the port assembly is rated for power injection, the one or more cutouts further configured to be visually discernable to a naked eye from both the top surface of the flange and the bottom surface of the flange prior to implantation of the port assembly; and

a discharge port extending from the housing.

13. The port assembly of claim 12, wherein the flange comprises the X-ray discernable material and the one or more cutouts extend entirely through the X-ray discernable material from the top surface of the flange to the bottom surface of the flange.

14. The port assembly of claim 12, wherein the top surface and the bottom surface of the flange are coated with the X-ray discernable material.

15. The port assembly of claim 12, wherein the one or more cutouts are further configured to indicate, under X-ray examination, that the port assembly is rated to be used for power injection of contrast fluid.

16. The port assembly of claim 12, wherein the one or more cutouts are further configured to indicate, under X-ray examination, that the port assembly is adapted to withstand high pressures used for injection of contrast fluid.

17. An implantable venous access port assembly comprising:

a needle-penetrable septum;

a housing securing the needle-penetrable septum, the housing comprising a housing base defining at least one reservoir, and a flange extending radially from the housing base, the flange comprising;

a height extending from a top surface of the flange to a bottom surface of the flange;

one or more X-ray discernable indicia formed in the flange and extending through the height of the flange from the top surface of the flange to the bottom surface of the flange, the one or more X-ray discernable indicia configured to indicate, under X-ray examination, that the port assembly is rated for power injection, the one or more X-ray discernable indicia further configured to be visually discernable to a naked eye from both the top surface of the flange and the bottom surface of the flange prior to implantation of the port assembly; and

a discharge port extending from the housing.

18. The port assembly of claim 17, wherein the flange further comprises one or more cutouts disposed about peripheries of the one or more X-ray discernable indicia.

19. The port assembly of claim 18, wherein:

the flange comprises X-ray discernable material extending entirely through the height of the flange from the top surface of the flange to the bottom surface of the flange,

the one or more X-ray discernable indicia extend entirely through the X-ray discernable material from the top surface of the flange to the bottom surface of the flange, and

the one or more cutouts extend entirely through the X-ray discernable material from the top surface of the flange to the bottom surface of the flange.

20. The port assembly of claim 18, wherein:

the top surface and the bottom surface of the flange are coated with the X-ray discernable material.

21. The port assembly of claim 17, wherein the one or more X-ray discernable indicia are further configured to indicate, under X-ray examination, that the port assembly is rated to be used for power injection of contrast fluid.

22. The port assembly of claim 17, wherein the one or more X-ray discernable indicia are further configured to indicate, under X-ray examination, that the port assembly is adapted to withstand high pressures used for injection of contrast fluid.