Implantable access port including a sandwiched radiopaque insert

• US 9,474,888 B2
• Filed: 08/21/2013
• Issued: 10/25/2016
• Est. Priority Date: 03/04/2005
• Status: Active Grant

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Wiley, Martha, Eliasen, Kenneth A., Hibdon, Dwight T., McKinnon, Melissa A., Powers, Kelly B., Cise, David M., Maniar, Ketan K.
• Primary Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US13/972,538
• Publication Number:
  US 20130338494A1
• Time in Patent Office: 1,161 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• 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 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• 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 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: B29C 45/0053 combined with a final operation, e.g. shaping injection-compression moulding B29C45/561
• CPC Class Codes: B29C 65/08 using ultrasonic vibrations non-plastics element to plastics elements B29C65/645
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An access port for subcutaneous implantation is disclosed. The access port may include a body for capturing a septum for repeatedly inserting a needle therethrough into a cavity defined within the body. The access port may further include at least one feature structured and configured for identification of the access port subsequent to subcutaneous implantation. Methods of identifying a subcutaneously implanted access port are also disclosed. For example, a subcutaneously implanted access port may be provided and at least one feature of the subcutaneously implanted access port may be perceived. The subcutaneously implanted access port may be identified in response to perceiving the at least one feature. In one embodiment, an identification feature is included on a molded insert that is sandwiched between base and cap portions of the access port so as to be visible after implantation via x-ray imaging technology.

Claims

1. An implantable access port, comprising:

a port body including a base portion and a cap portion that are cooperatively mated to one another;

a fluid cavity defined by at least one of the base portion and the cap portion;

a stem integrally formed with one of the base and cap portions and in fluid communication with the fluid cavity;

a needle-penetrable septum covering an opening of the fluid cavity; and

a radiopaque insert including;

an insert body including a radiopaque material and shaped to be fixedly interposed between the base and cap portions when the base and cap portions are mated, the insert body further defining at least one contoured portion that enables the radiopaque insert to fit about correspondingly shaped features of at least one of the base portion and the cap portion; and

at least one indicium observable via x-ray imaging technology subsequent to subcutaneous implantation of the implantable access port in a patient, the at least one indicium conveying to an observer a predetermined attribute of the access port.

2. The access port as defined in claim 1, wherein the base portion and the cap portion of the port body include poly ether ether ketone and wherein the stem is integrally formed with the base portion.

3. The access port as defined in claim 1, wherein the at least one contoured portion fits between the stem and a corresponding recess defined by the cap portion.

4. The access port as defined in claim 1, wherein the base portion of the port body includes a plurality of extending feet and wherein the at least one contoured portion includes a plurality of contoured portions, wherein one of the plurality of contoured portions fits about each foot of the plurality of extending feet of the base portion.

5. The access port as defined in claim 1, wherein the predetermined attribute of the access port is its suitability for power injection.

6. The access port as defined in claim 1, wherein the radiopaque insert includes both a base material and the radiopaque material and wherein the radiopaque material includes a bismuth-containing compound.

7. The access port as defined in claim 1, wherein the radiopaque material includes at least one of bismuth trioxide, bismuth subcarbonate, bismuth oxychloride, zirconium oxide, aluminum oxide, and titanium dioxide.

8. The access port as defined in claim 1, wherein the at least one indicium includes alphanumeric characters.

9. The access port as defined in claim 1, wherein the fluid cavity is defined by both the cap portion and the base portion, and wherein an opening of the fluid cavity is defined by the cap portion.

10. The access port as defined in claim 1, wherein the stem is integrally formed with the base portion of the port body and wherein the at least one contoured portion of the insert body of the radiopaque insert is shaped to fit about a portion of the stem.

11. The access port as defined in claim 1, wherein a portion of the radiopaque insert remains external to the port body after mating of the cap portion and the base portion.

12. The access port as defined in claim 1, wherein the base portion and the cap portion of the port body are ultrasonically welded together after interposition of the radiopaque insert therebetween.

13. The access port as defined in claim 12, wherein a plurality of ultrasonic welding features are disposed on the cap portion and arranged in a circular pattern about the fluid cavity, each welding feature defining a triangular tooth.

14. An implantable access port, comprising:

a port body including a base portion and a cap portion that are cooperatively mated to one another, the base portion and the cap portion including poly ether ether ketone;

a fluid cavity defined by the base portion and the cap portion;

a stem integrally formed with the base portion and in fluid communication with the fluid cavity;

a needle-penetrable septum covering an opening of the fluid cavity defined by the cap portion; and

a radiopaque insert including;

an insert body including a bismuth-containing material and shaped to be fixedly interposed between the base and cap portions when the base and cap portions are mated, the insert body further defining at least one contoured portion that enables the radiopaque insert to fit about the stem of the base portion; and

at least one indicium observable via x-ray imaging technology subsequent to subcutaneous implantation of the implantable access port in a patient, the at least one indicium conveying to an observer that the implantable access port is power injectable.

15. The access port as defined in claim 14, wherein the at least one indicium of the radiopaque insert includes a letter “

C” and

a letter “

T”

.

16. The access port as defined in claim 15, wherein the radiopaque insert is generally triangularly shaped and defines a hole to enable the radiopaque insert to receive therethrough a portion of the base portion.

17. The access port as defined in claim 16, wherein the radiopaque insert is formed via an injection molding process and wherein the radiopaque insert is formed by a mixture including about 70 percent acetyl resin and about 30 percent bismuth trioxide by weight.

18. The access port as defined in claim 17, wherein the base portion includes a plurality of feet, the at least one contoured portion including a plurality of contoured portions, wherein one of the plurality of contoured portions fits about each foot of the plurality of feet.