# US 11,077,291 B2 · Implantable access port including a sandwiched radiopaque insert

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- Number: US 11,077,291 B2
- Document ID: US11077291B2
- Status: Granted
- Kind: B2
- Application number: 16/389,732
- Filed: 2019-04-19
- Published: 2019-08-15
- Granted: 2021-08-03
- Earliest claimed: 2005-03-04
- Assignees: Bard Peripheral Vascular, Inc.
- Applicants: Bard Peripheral Vascular, Inc.
- Inventors: Martha R. Wiley; Kenneth A. Eliasen; Dwight T. Hibdon; Melissa A. McKinnon; Kelly B. Powers; David M. Cise; Ketan K. Maniar
- Web page: https://patentgrep.com/patent/US11077291B2

## CPC

- A61M 39/0247: {Transcutaneous or percutaneous access sites to the inside of the body}
- A61B 6/12: Arrangements for detecting or locating foreign bodies
- A61M 39/0208: {Subcutaneous access sites (implantable infusion devices A61M5/14276; transcutaneous access sites A61M39/0247)}
- B29C 45/0053: {combined with a final operation, e.g. shaping (injection-compression moulding B29C45/561)}
- B29C 65/08: using ultrasonic vibrations {(non-plastics element to plastics elements B29C65/645)}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61M 2039/0211: {with multiple chambers in a single site}
- A61M 2039/0238: {having means for locating the implanted device to insure proper injection, e.g. radio-emitter, protuberances, radio-opaque markers}
- A61M 2205/32: with radio-opaque indicia
- A61M 2205/582: by tactile feedback
- A61M 2205/6054: Magnetic identification systems
- A61M 2207/00: Methods of manufacture, assembly or production
- B29L 2031/753: {Medical equipment; Accessories therefor (bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008)}
- Y10T 29/49826: Assembling or joining
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## 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

### Claim 1

A method of performing a power injection procedure, comprising:
imaging an implanted power injectable access port using x-ray imaging technology to produce an x-ray image, the power injectable access port comprising:
a port body including a base portion and a cap portion;
a radiopaque insert comprising:
a contoured portion interposed between the base portion and the cap portion, the base portion mated to the cap portion with a portion of the contoured portion visible prior to implantation; and
an identification feature observable via imaging technology to indicate that the power injectable access port is suitable for power injection;
determining whether the identification feature is present on the x-ray image; and
proceeding with the power injection procedure if the identification feature is present on the x-ray image.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the power injectable access port further comprises a septum covering an opening in the cap portion, the opening in communication with a fluid cavity defined by the base portion and the cap portion.

### Claim 3 (depends on 2)

The method according to claim 2, wherein the base portion includes a stem integrally formed therewith, the stem in fluid communication with the fluid cavity, wherein the contoured portion is positioned between the stem and a corresponding recess defined by the cap portion.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the base portion includes a plurality of extending feet, and wherein the radiopaque insert comprises a plurality of contoured portions, each of the plurality of contoured portions positioned about respective feet of the plurality of extending feet.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the radiopaque insert includes a radiopaque material selected from the group consisting of bismuth trioxide, bismuth subcarbonate, bismuth oxychloride, zirconium oxide, aluminum oxide, titanium dioxide, and combinations thereof.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the radiopaque insert comprises about 70 percent acetyl resin and about 30 percent bismuth trioxide by weight.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the base portion is ultrasonically welded to the cap portion.

### Claim 8 (depends on 7)

The method according to claim 7, wherein a plurality of ultrasonic welding features are disposed on the cap portion and arranged in a circular pattern about a fluid cavity defined by the base portion and the cap portion, each of the plurality of ultrasonic welding features defining a triangular tooth.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the proceeding step comprises flowing a viscous contrast media through the power injectable access port if the identification feature is present on the x-ray image.

### Claim 10 (depends on 9)

The method according to claim 9, wherein the port body includes polyether ether ketone (“PEEK”), and wherein the flowing step comprises injecting the viscous contrast media at a rate of about 5 mL per second.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the identification feature includes a first void through a thickness of the radiopaque insert, and a second void through the thickness of the radiopaque insert, the first void having a letter “C” shape, the second void having a letter “T” shape.

### Claim 12 (depends on 11)

The method according to claim 11, wherein the letter “C” shape and the letter “T” shape are configured in a mirror image orientation through the thickness of the radiopaque insert, the determining step comprising viewing “CT” on the x-ray image.

### Claim 13 (depends on 11)

The method according to claim 11, wherein the port body includes a suture opening, and wherein the letter “C” shape and the letter “T” shape are positioned on opposite sides of the suture opening.

### Claim 14 (depends on 11)

The method according to claim 11, wherein the thickness is about 0.033 inch.

### Claim 15 (depends on 1)

The method according to claim 1, wherein the radiopaque insert includes a base material and a radiopaque material, the base material comprising acetyl resin, and the radiopaque material comprising bismuth oxychloride or bismuth subcarbonate.

### Claim 16 (depends on 15)

The method according to claim 15, wherein the radiopaque material is in a range from about 25 percent to about 40 percent by weight.

### Claim 17 (depends on 15)

The method according to claim 15, wherein the base material includes about 45 percent to about 50 percent zirconium oxide by weight.
