Patent Description:
<CIT> discloses an access port for providing subcutaneous access to a patient, including at least one structural element configured for resisting deformation of the septum in response to a pressure developed within the reservoir.

The instant disclosure relates generally to percutaneous access and, more specifically, to methods and devices associated with percutaneous access. Generally, the instant disclosure relates to an access port for subcutaneous implantation. In one embodiment, an access port may allow a physician or other medical personnel to obtain long term percutaneous access to the interior of a patient's body. Employing an access port for percutaneous access may reduce the opportunity for infection by inhibiting fluid connections (that extend into the interior of a patient's body) from the patient's skin and from the external environment. The access device allows access to the interior of the patient without requiring a needle to pierce the skin. Further, internal components, such as a catheter or a valve, may be replaced without a surgical procedure. Features or aspects of the instant disclosure may apply to any such access ports for subcutaneous access to a patient, without limitation. The access port may be injected by hand (e.g., via a syringe including a needle) for example, or may be injected and pressurized by mechanical assistance (e.g., a so-called power injectable port).

Power injectable ports may be employed in, among other processes, for example, computed tomography ("CT") scanning processes. More particularly, a so-called "power injector" system may be employed for injecting contrast media into a peripherally inserted intravenous (IV) line. For example, such power injectors or injection systems may be commercially available from Medrad, Inc. , a subsidiary of Schering AG, Germany and may be marketed under the trademark STELLANT®. Because fluid infusion procedures are often defined in terms of a desired flow rate of contrast media, such power injection systems are, in general, controllable by selecting a desired flow rate.

More specifically, the instant disclosure relates to an access port having at least one perceivable or identifiable feature for identifying the access port, wherein the identifiable feature is perceivable after the access port is implanted within a patient. For example, at least one or perhaps multiple identifiable feature(s) of an access port contemplated by the instant disclosure may be correlative to information (e.g., a manufacturer's model or design) pertaining to the access port. Thus, an identifiable feature from an access port of a particular model may be unique in relation to most if not all other identifiable features of another access port of a different models or design. Of course, the at least one identifiable feature of an access port contemplated by the instant disclosure may be further correlative with any information of interest, such as type of port, catheter type, date of manufacture, material lots, part numbers, etc. In one example, at least one identifiable feature of an access port may be correlative with the access port being power injectable. In this way, once at least one identifiable feature of an access port is observed or otherwise determined, correlation of such at least one feature of an access port may be accomplished, and information pertaining to the access port may be obtained.

In one embodiment, at least one feature may be perceived by palpation (i.e., to examine by touch), by way of other physical interaction, or by visual observation. Accordingly, a person of interest may touch or feel the access port through the skin to perceive at least one identifying characteristic thereof. In another embodiment, at least one identifiable feature may be perceived via x-ray or ultrasound imaging. In yet a further embodiment, at least one identifiable feature may be perceived through magnetic, light, or radio energy interaction or communication with the access port.

Turning to the embodiment wherein at least one feature may be perceived through palpation, other physical interaction, or visual observation, a topography or exterior surface feature of an access port contemplated by the instant disclosure may be configured for perception. For example, referring to <FIG>, an exemplary access port <NUM> contemplated by the instant disclosure is shown. <FIG> show a perspective view and a schematic side cross-sectional view, respectively, of an access port <NUM> for allowing percutaneous or otherwise internal access to a patient's body. Access port <NUM> includes a housing or body <NUM> defined by a cap <NUM> and a base <NUM>. Cap <NUM> and base <NUM>, as known in the art, may be configured for capturing therebetween a septum <NUM>. As shown in <FIG>, cap <NUM> and base <NUM> may matingly engage one another along a mating line <NUM>. Cap <NUM> and base <NUM> may be secured or affixed to one another via mechanical fasteners such as screws or other fastening devices, may be adhesively affixed to one another, or may be affixed to one another as known in the art. Further, cap <NUM>, base <NUM>, and septum <NUM> may collectively define a cavity <NUM> in fluid communication with a lumen <NUM> of outlet stem <NUM>.

The body <NUM> may be implanted in a patient <NUM>, as shown in <FIG>, to dispose the cavity <NUM> subcutaneously within the patient <NUM>. Also, suture apertures <NUM> (<FIG>) may be used to affix the access port <NUM> within the patient <NUM>, if desired. After the body <NUM> is implanted in a patient <NUM>, the upper surface of the septum <NUM> may be substantially flush with the surface of the skin <NUM> of the patient <NUM> and may be repeatedly punctured for creating a percutaneous passageway from the exterior of the skin of the patient into the cavity <NUM>. The outlet stem <NUM> may create a fluid-communicative passageway from the cavity <NUM> through the outlet stem <NUM> and into the interior of the patient <NUM>. A catheter may be coupled to the outlet stem <NUM> for fluid communication with the cavity <NUM> and for transferring fluid from the cavity <NUM> to a desired remote location from the cavity <NUM> and within a patient <NUM>.

Body <NUM> of access port <NUM> may comprise a bio-compatible material such as polysulfone, titanium, or any other suitably bio-compatible material as known in the art. Accordingly, the body <NUM> may be formed from a bio-compatible plastic material. If desired, the body <NUM> may comprise a penetrable material for penetration by sutures or needles. In another embodiment, and as discussed further hereinbelow, body <NUM> may comprise an impenetrable material such as, for instance, a metal if desired. Body <NUM> may include a concave bottom or, in another embodiment, may include a flat bottom, without limitation.

According to the instant disclosure, access port <NUM> may comprise a body <NUM> exhibiting at least one identifiable feature. More particularly, as shown in <FIG>, body <NUM> may exhibit a partial generally pyramidal shape (i.e., a polygonal base having surfaces for each side of the polygon extending toward a common vertex otherwise known as a frustum). Generally, a body <NUM> of an access port <NUM> may exhibit a partial pyramidal shape extending between a generally quadrilateral shaped base positioned at reference plane <NUM> and a generally quadrilateral shaped upper base positioned at reference plane <NUM>. Reference planes <NUM> and <NUM> will not be shown in <FIG>, for clarity; however, reference to planes <NUM> or <NUM> with respect to <FIG>, as used herein, will refer to corresponding reference planes analogous to reference planes <NUM> and <NUM> as shown in <FIG>.

As shown in <FIG>, the exterior of access port <NUM> is substantially defined by four substantially planar side surfaces <NUM> connected to one another by radiuses <NUM>. In addition, the upper topography <NUM> of access port <NUM> is defined by upper surface <NUM> in combination with chamfers 46A and 46B and may be further defined by the upper surface of septum <NUM>. Explaining further, the outer periphery of upper topography <NUM> may be described as a generally quadrilateral exterior formed by side regions <NUM> and having rounded corner regions <NUM> adjacent side regions <NUM>. Such a configuration may provide an access port having at least one feature that may be perceived by palpation.

It may be appreciated that there are many variations to the geometry of access port <NUM> as shown in <FIG>. For instance, while the body <NUM> of access port <NUM> may be described as a partially pyramidal shape or frustum, the instant disclosure is not so limited. Rather, one or more of side surfaces <NUM> may be oriented at as may be desired, without reference to any other side surfaces <NUM>. Accordingly, for example, one of surfaces <NUM> may be substantially vertical while the remaining surfaces <NUM> may be oriented at respective, selected angles. Furthermore, it should be understood that <FIG> is merely exemplary and that the dimensions and shape as shown in <FIG> may vary substantially while still being encompassed by the instant disclosure.

<FIG> shows a perspective view of another embodiment of access port <NUM> according to the instant disclosure. As shown in <FIG>, the exterior of access port <NUM> is substantially defined by a generally parallelogram-shaped base (positioned at reference plane <NUM> as shown in <FIG>) extending generally pyramidally to a generally parallelogram-shaped upper surface (positioned at reference plane <NUM> as shown in <FIG>). As shown in <FIG>, radiuses <NUM> may be larger than radiuses <NUM> as shown in <FIG>. Furthermore, the upper topography <NUM> of access port <NUM> as shown in <FIG> may include rounded corner regions <NUM> which are larger than rounded corner regions <NUM> as shown in <FIG>. Thus, <FIG> shows an exemplary embodiment of an access port <NUM> that may be perceivably distinguishable from access port <NUM> as shown in <FIG>. For example, a difference between one exterior of an access port contemplated by the instant disclosure and another exterior of a different access port contemplated by the instant disclosure may be determined by way of palpation.

In another embodiment, in another aspect contemplated by the instant disclosure, a template may be employed for perceiving at least one feature of an access port. For instance, a complementarily-shaped template may be positioned over and abutted against an access port contemplated by the instant disclosure so as to determine if the access port matches or substantially corresponds to the shape of the template. Such a process may reliably indicate or perceive at least one feature of an access port contemplated by the instant disclosure. Of course, a plurality of templates corresponding to different models of access ports may be serially engaged with an unknown access port so as to perceive at least one feature thereof. Such a process may allow for identification (e.g., of a model or manufacturer) of an access port contemplated by the instant disclosure.

In another aspect contemplated by the instant disclosure, an upper topography of an access port may include at least one feature for identifying the access port. For example, as shown in <FIG>, upper surface <NUM> of access port <NUM> may be nonplanar. More specifically, upper surface <NUM> may be tapered or may arcuately extend downwardly (i.e., toward reference plane <NUM> as shown in <FIG>) as it extends radially inwardly toward septum <NUM>. Otherwise, access port <NUM>, as shown in <FIG>, may be configured substantially as described hereinabove with reference to <FIG>. Thus, upper surface <NUM> is one exemplary example of at least one perceivable feature for identification of an access port contemplated by the instant disclosure.

In yet a further embodiment of an access port contemplated by the instant disclosure, side regions <NUM> extending between rounded corner regions <NUM> may exhibit at least one perceivable feature. For example, as shown in <FIG>, access port <NUM> may include one or more side regions <NUM> that extend arcuately between adjacent rounded corner regions <NUM>. Otherwise, access port <NUM>, as shown in <FIG>, may be configured substantially as described hereinabove with reference to <FIG>. Side regions <NUM> may be congruent or symmetric with respect to one another or, in another embodiment, may be configured differently with respect to one another, without limitation.

<FIG> shows a further exemplary embodiment of an access port contemplated by the instant disclosure. More specifically, access port <NUM>, as shown in <FIG>, includes side regions <NUM> that form recessed regions <NUM> between adjacent rounded corner regions <NUM>. Put another way, the upper topography <NUM> may include alternating recessed regions <NUM> and protruding regions <NUM> positioned generally about a periphery of septum <NUM>. Otherwise, access port <NUM>, as shown in <FIG>, may be configured substantially as described hereinabove with reference to <FIG>. Such a configuration may provide an access port having at least one identifiable feature.

In a further embodiment of an access port contemplated by the instant disclosure, <FIG> show a perspective view and a side view, respectively, of an access port <NUM> generally configured as is described with reference to <FIG> but having an elongated body 20E. More specifically, elongated body 20E of access port <NUM>, as shown in <FIG>, includes a side surface 50E that extends generally from upper topography <NUM> downwardly (i.e., toward reference plane <NUM> as shown in <FIG>) and having a slope (e.g., an angle with respect to a vertical axis normal to an upper surface of septum <NUM>) which is different from the other side surfaces <NUM>. Otherwise, access port <NUM>, as shown in <FIG>, may be configured substantially as described hereinabove with reference to <FIG>. Such a configuration may provide an elongated body 20E of an access port <NUM> having an elongated side portion.

Of course, one or more side surfaces of an access port according to the instant disclosure may be configured for forming a body exhibiting a selected shape as may be desired. An elongated body portion of an access port contemplated by the instant disclosure may form, in combination with other features as described hereinabove or, in another embodiment, taken alone, at least one perceivable feature for identification of an access port according to the instant disclosure.

<FIG> shows a further embodiment of an access port encompassed by the instant disclosure. Particularly, as shown in <FIG>, access port <NUM> may include an upper body portion 20a and a lower body portion 20b. Furthermore, each of upper body portion 20a and lower body portion 20b may exhibit a partial pyramidal shape (i.e., a frustum), wherein the body portions 20a and 20b are stacked vertically with respect to one another. Accordingly, upper body portion 20a may form an overhanging rim feature <NUM> extending along a periphery of access port <NUM>. Explaining further, lower body portion 20b may have an exterior substantially defined by side surfaces 50b and rounded corner regions 30b, while upper body portion 20a may have an exterior substantially defined by side surfaces 50a, rounded corner regions 30a, and upper topography <NUM>. It may be appreciated that overhanging rim feature <NUM> may be sized and configured for perception via palpation. Such a configuration may provide a suitable access port for delivery of a beneficial or medicinal substance, the access port being identifiable (e.g., by model number, manufacturer, etc.) after implantation.

It should be understood that the instant disclosure contemplates access ports having an exterior geometry that is not quadrilateral in nature. Rather, the instant disclosure contemplates that an access port may have an exterior which is generally cylindrical, generally conical, generally elliptical, generally oval, or an exterior that is otherwise arcuate in nature. Specifically, the instant disclosure contemplates that an access port having a substantially rounded or arcuate exterior may include at least one feature configured for identification of the access port after implantation. For example, as shown in <FIG>, shows a cap <NUM> that exhibits an exterior surface <NUM> that is substantially conical. Cap <NUM> may be assembled to a suitable base (not shown) for capturing a septum (not shown) as described hereinabove to form an access port <NUM> as generally described with reference to <FIG>.

The instant disclosure further contemplates that at least one protrusion, protruding region, recess, recessed region, undulation, or adjacent features of different elevation may comprise a feature for identifying an access port contemplated by the instant disclosure. More specifically, upper topography 61C, as shown in <FIG>, may include a plurality of protrusions <NUM>. Protrusions <NUM> may exhibit partially spherical upper surfaces that transition into a lower portion of cap <NUM>. In further detail, protrusions <NUM> may be circumferentially spaced about the periphery of septum (not shown) as may be desired. In one embodiment, a plurality of protrusions <NUM> may be symmetrically circumferentially spaced about the periphery of septum (not shown). More generally, at least one protrusion <NUM> may be sized, configured, and positioned for forming at least one identifiable feature of an access port. Of course, at least one protrusion <NUM> may be structured for facilitating comfort of a patient within which the access port is implanted. As may be appreciated, at least one protrusion <NUM> or more than one protrusion <NUM> may be included in an upper topography 61C of an access port (not shown) contemplated by the instant disclosure.

<FIG> shows another embodiment of a cap <NUM> including at least one protrusion 80E for forming and identifying an access port contemplated by the instant disclosure after implantation thereof within a patient. Protrusions 80E may extend circumferentially about a center of revolution. Thus, protrusions 80E may exhibit a body <NUM> portion circumferentially extending between rounded ends <NUM>. Further, cap <NUM> may have an exterior surface <NUM> that is substantially symmetric about an axis of revolution. More generally, body <NUM> may extend from a generally circular, generally elliptical, or generally oval base positioned at a lower extent <NUM> of the cap <NUM> to an upper generally circular, generally elliptical, or generally oval cross section that is smaller than a cross section of the base and is positioned at an upper extent <NUM> (without considering protrusions 80E) of the cap <NUM>. In addition, side surface <NUM>, as shown in <FIG>, extends arcuately between the base and the upper topography <NUM> of cap <NUM>. Side surface <NUM> may extend in a generally tapered or conical fashion, may exhibit a radius or other arcuate shape, or may otherwise transition between a cross section of the base of the access port to a cross section proximate the upper topography 61C thereof.

Further, <FIG> shows an embodiment of a cap <NUM> for forming an access port contemplated by the instant disclosure having an upper topography 61C thereof comprising alternating circumferentially extending protrusions 80E and circumferentially extending recesses <NUM>, wherein the circumferentially extending protrusions 80E are circumferentially larger than the circumferentially extending recesses 80E. In another embodiment of an access port contemplated by the instant disclosure, <FIG> shows a perspective view of a cap <NUM> having an upper topography 61C thereof comprising alternating circumferentially extending protrusions 80E and circumferentially extending recesses <NUM>, wherein the circumferentially extending protrusions 80E and the circumferentially extending recesses <NUM> are substantially equal in (circumferential) sized or extension. In yet a further embodiment of a cap <NUM> for forming an access port contemplated by the instant disclosure, <FIG> shows a perspective view of a cap <NUM> having an upper topography 61C thereof comprising three circumferentially extending protrusions 80E and three circumferentially extending recesses <NUM>, arranged so as to alternate circumferentially, wherein the circumferentially extending protrusions 80E and the circumferentially extending recesses <NUM> are substantially equal in (circumferential) size.

<FIG> shows a perspective view of an additional embodiment of an cap <NUM> for forming an access port contemplated by the instant disclosure including an upper topography 61C including circumferentially extending protrusions 80T and circumferentially extending recesses 82T, wherein transition regions <NUM> are provided between circumferentially extending protrusions 80T and circumferentially extending recesses 82T. Such transition regions <NUM>, as shown in <FIG>, may taper or generally smoothly transition between a circumferentially extending protrusion 80T and a circumferentially extending recess 82T. Also, <FIG> shows a perspective view of an additional embodiment of a cap <NUM> for forming an access port contemplated by the instant disclosure including an upper topography 61C including protrusion regions <NUM> and recessed regions <NUM> that transition between one another and alternate circumferentially so as to form an undulating topography comprising upper topography 61C. Such an undulating topography, as shown in <FIG>, generally smoothly transitions between circumferentially adjacent protrusion regions <NUM> and recessed regions <NUM>.

In a further embodiment of an access port contemplated by the instant disclosure, <FIG> show a perspective view and a top elevation view, respectively, of an access port <NUM> generally configured as is described with reference to <FIG> but may include at least one nonplanar side surface. In another embodiment, access port <NUM> as shown in <FIG> may be configured as shown in <FIG> or <FIG>, or any embodiments described hereinbelow, without limitation. More specifically, elongated body <NUM> of access port <NUM>, as shown in <FIG>, includes three side surfaces 50R that extend arcuately (as shown in <FIG>). Such a configuration may provide an access port <NUM> that is identifiable subsequent to implantation. In yet another embodiment of an access port contemplated by the instant disclosure, <FIG> shows a perspective view of an access port <NUM> including a side wall <NUM> that truncates a portion of a radius <NUM> formed between side surfaces <NUM> of access port <NUM>. It may also be noted that such an access port <NUM> may include three suture apertures <NUM>, which may, taken alone or in combination with at least one other feature, comprise at least one identifiable feature of an access port contemplated by the instant disclosure. In addition, as shown in <FIG>, outlet stem <NUM> may extend from side wall <NUM>.

In a further embodiment of an access port contemplated by the instant disclosure, <FIG> shows a perspective view of an access port <NUM> wherein cap <NUM> and base <NUM>, when assembled to one another along mating line <NUM>, form a flange feature or lip feature <NUM> that extends about at least a portion of the periphery of the access port <NUM>. As shown in <FIG>, lip feature <NUM> extends substantially about the periphery of the access port <NUM>, proximate to the mating line <NUM> between cap <NUM> and base <NUM>. Such a feature may comprise at least one identifiable feature of an access port contemplated by the instant disclosure. Thus, it may be appreciated that a peripheral discontinuity between the cap <NUM> and base <NUM> may be formed generally along the mating line <NUM> therebetween. In the embodiment of an access port as shown in <FIG>, an overhanging rim feature <NUM> may comprise a peripheral discontinuity or, in the embodiment of an access port as shown in <FIG>, a lip feature <NUM> may comprise a peripheral discontinuity.

In a further embodiment of an access port contemplated by the instant disclosure, <FIG> shows a perspective view of an access port <NUM> wherein at least a portion of at least one side surface <NUM> is concave. As shown in <FIG>, concave region <NUM> of side surface <NUM> is concave. Concavity (i.e., a concave region <NUM>) may be exhibited over at least a portion of a side surface of an access port of any of the embodiments as shown herein, without limitation. Thus, at least one side surface <NUM> of an access port contemplated by the instant disclosure having at least at least a portion thereof that is concave is one exemplary example of at least one perceivable feature for identification of an access port contemplated by the instant disclosure.

In a further embodiment of an access port contemplated by the instant disclosure, <FIG> shows a perspective view of an access port <NUM> wherein at least a portion of at least one side surface <NUM> is concave. As shown in <FIG>, region <NUM> of side surface <NUM> is concave. Concavity may be exhibited over at least a portion of a side surface of an access port of any of the embodiments as shown herein, without limitation. Thus, at least one side surface <NUM> of an access port contemplated by the instant disclosure having at least at least a portion thereof that is concave is one exemplary example of at least one perceivable feature for identification of an access port contemplated by the instant disclosure.

In a further embodiment of an access port contemplated by the instant disclosure, <FIG> shows a perspective view of an access port <NUM> generally configured as is described with reference to <FIG>. More specifically, elongated body 20ER, as shown in <FIG> includes a side surface 50ER that extends arcuately from upper topography <NUM> of access port <NUM> downwardly (i.e., toward reference plane <NUM> as shown in <FIG>). Such a configuration may provide an elongated body 20E of an access port <NUM> having an elongated side portion.

It should be understood from the above-described various embodiments of an access port contemplated by the instant disclosure that many variations, additions, or different features may be encompassed by the instant disclosure. Thus, the instant disclosure is not limited to the several above-described exemplary embodiments.

For example, as shown in <FIG>, which shows a top elevation view of an access port <NUM> contemplated by the instant disclosure, an access port <NUM> may include a side wall <NUM> that at least partially truncates a radius <NUM> between side surfaces <NUM>, outlet stem <NUM> extending from side wall <NUM>, and at least one of a concave region <NUM> and an arcuate surface 50R. Further, as shown in <FIG>, suture apertures <NUM> may be positioned so as to identify the access port <NUM> after subcutaneous implantation.

Additionally, the instant disclosure contemplates access ports having an exterior geometry that is polygonal in nature. Specifically, the instant disclosure contemplates that an access port contemplated by the instant disclosure may exhibit a generally triangular exterior. Thus, as shown in <FIG>, body <NUM> may exhibit a generally pyramidal or tapered shape (i.e., a polygonal base having surfaces for each side of the polygon extending toward a common vertex). Generally, a body 20T of an access port <NUM> may extend between a generally triangularly-shaped base and a relatively smaller, generally triangularly-shaped upper base. Accordingly, the exterior of access port <NUM> may be substantially defined by three side surfaces (e.g., <NUM>, 50R, <NUM>, 50E) having radiuses <NUM> extending therebetween. In addition, the upper topography <NUM> of access port <NUM> may be defined by upper surface <NUM> in combination with side regions <NUM> and rounded corner regions <NUM>. Such a configuration may provide an access port having at least one feature that may be perceived by palpation.

<FIG> and <FIG> show a perspective view and a top elevation view of another embodiment of an access port including a generally triangular exterior geometry. More particularly, as shown in <FIG> and <FIG>, a cap <NUM> and base <NUM> (collectively forming a housing) may capture a septum <NUM> to form an access port <NUM>. Further, outlet stem <NUM> may include a stem base that may be positioned within and sealed to an outlet recess <NUM> formed within base <NUM>. The outlet stem <NUM> may be in fluid communication with a cavity formed within the access port <NUM>. Optionally, suture plugs <NUM> may be positioned within suture cavities <NUM> formed in base <NUM>. Suture plugs <NUM> may comprise a pliant material (e.g., silicone, rubber, etc.) that may provide some resilience between sutures coupling the access port <NUM> (i.e., the base <NUM>) to a patient. In further detail, a side periphery <NUM> (e.g., one or more side walls) of access port <NUM> may be generally triangular. Thus, cap <NUM> and base <NUM> may collectively form a generally triangular housing or body of access port <NUM>. Also, the instant disclosure contemplates that side periphery <NUM> may increase or decrease in cross-sectional size (e.g., by tapering or arcuately transforming) between upper surface <NUM> of cap <NUM> and lower surface <NUM> of base <NUM>. As shown in <FIG> and <FIG>, a transverse cross section (taken in a selected plane substantially parallel to lower surface <NUM> of base <NUM>) of access port <NUM> may be larger proximate to lower surface <NUM> of base <NUM> and may be relatively smaller proximate upper surface <NUM> of cap <NUM>.

Additionally, <FIG> shows a simplified representation of a transverse cross section of access port <NUM>. As shown in <FIG>, side periphery <NUM> of access port <NUM> may define three side regions <NUM> that extend between associated vertex regions <NUM>. In addition, in one embodiment and as shown in <FIG>, side periphery <NUM> may define a substantially equilateral generally triangular shape. As one of ordinary skill in the art will appreciate, side regions <NUM> may arcuately extend between associated vertex regions <NUM>; thus, side regions <NUM> may form "sides" of a generally triangular shape. Further, although vertex regions <NUM> are rounded, it may be appreciated that such vertex regions <NUM> form an intersection between adjacent side regions <NUM>. Accordingly, one of ordinary skill in the art will appreciate that the phrase "generally triangular," as used herein, encompasses any generally three-sided geometry wherein adjacent sides intersect, without limitation. For example, the phrase "generally triangular" encompasses three sided polygons, circular triangles, equilateral triangles, etc., without limitation.

The instant disclosure also contemplates that at least one feature of an access port contemplated by the instant disclosure may not be observable visually or by palpation but, rather, may be otherwise observable. For example, the instant disclosure contemplates that at least one feature of an access port may be observable through interaction with an imaging technology such as x-ray or ultrasound. For example, in one embodiment, a metal feature (e.g., a plate or other metal geometry) may be included by an access port contemplated by the instant disclosure. As may be appreciated, such a metal feature may be represented on an x-ray generated by exposure of the access port to x-ray energy while simultaneously exposing x-ray sensitive film to x-ray energy passing through the access port. Further, the instant disclosure contemplates that a size, shape, or both size and shape of a metal feature of an access port may be configured for enhancing identification of an access port. For example, assuming that a metal feature comprises a metal plate, a size, shape, or both may be selectively tailored for identification of an access port. Similarly, a feature of an access port contemplated by the instant disclosure may be tailored for detection via ultrasound interaction. Such a feature may comprise an exterior topographical feature. In another embodiment, such a feature may comprise a composite structure including two or more materials that form an interface surface that may be identified by ultrasound imaging.

One example embodiment of a feature observable through interaction with imaging technology contemplated by the instant disclosure is shown in <FIG>, <FIG>, and <FIG>. <FIG> depicts a bottom perspective view of an access port <NUM>. <FIG> shows a top view of the access port <NUM>, while <FIG> shows a bottom view of the access port. The access port <NUM> of <FIG>, <FIG> is similar in some respects to the access port <NUM> as seen in <FIG> and <FIG>, including a cap <NUM> and a base <NUM> that cooperate to define a body. In the present example embodiment, however, the lower surface <NUM> of the base <NUM> includes an identification feature <NUM>, as seen in <FIG> and <FIG>. It is contemplated that the identification feature <NUM> can be one or more alphanumeric characters, such as the "CT" depicted. Additionally, the instant disclosure contemplates the use of other markings, such as one or more symbols, patterns, characters, designs, a combination thereof, etc. The identification feature <NUM> can be of any size, shape, or both in order to tailor the identification feature for the specific identification of one or more of a variety of characteristics of the access port. Specifically, in one embodiment the identification feature <NUM> can convey information to a practitioner regarding the power-injectability of the implanted access port. Note that in the present embodiment, the identification feature <NUM> is defined as a recessed feature, whereas in other embodiments the identification feature may be defined in other ways, as discussed hereafter.

As mentioned above, <FIG> depicts a top view of the access port <NUM>. Note that the identification feature <NUM> is not observable through the upper surface <NUM> of the cap <NUM> or through the septum <NUM> without the interaction of imaging technology. As seen in <FIG>, the alphanumeric characters of the identification feature <NUM>, "CT," are engraved mirror-reversed on the lower surface <NUM> of the base <NUM>. The "CT" is engraved mirror-reversed so that when imaging technology, such as x-ray imaging, is used to identify a subcutaneously implanted access port, the "CT" will be visible in the proper orientation. By engraving a desired identification feature mirror-reversed on the bottom surface of an access port, a practitioner will be able to determine if there is a problem with the port after implantation, such as if the access port has flipped or otherwise become mis-oriented while in the body of the patient. Thus, if the identification feature is seen mirror-reversed or askew in an x-ray image, the practitioner can correct the problem before attempts are made to use the access port.

Although also useful in access ports where only a portion of a port includes a metallic material, e.g., a metal plate, the engraving technique is well-suited in one embodiment for access ports that are composed of solid metal, such as titanium, stainless steel, or other materials that are typically radiopaque, i.e., non-transmissive to x-rays in sufficient thickness. <FIG> are representative images of the access port <NUM> of <FIG>, which includes titanium or other metallic material, as seen via x-ray imaging after implantation into the patient. The access port <NUM> includes the identification feature <NUM> as seen in <FIG> and <FIG>. Due to the relative thickness of the access port <NUM>, the material of the base <NUM> and cap <NUM> surrounding a cavity periphery 36A of the cavity <NUM>, which is a fluid cavity, is substantially non-transmissive to x-rays and therefore appears relatively dark in the x-ray image of <FIG>. However, the material of the access port <NUM> within the cavity periphery 36A is relatively thinner through a cavity base <NUM> (as seen in <FIG>) than through the material of the cap <NUM> and base <NUM>. Thus, additional thinning of the material when creating the identification feature <NUM> enables the identification feature to appear relatively more radiographically transmissive than the surrounding material of the cavity base under x-ray imaging. Note that the identification feature <NUM> in <FIG> is visible in the proper orientation, indicating that the access port is not flipped.

<FIG> and <FIG> are additional representative x-ray images of the identification feature <NUM> of the access port <NUM>, wherein the access port is tilted at angles of approximately <NUM> and <NUM> degrees, respectively. Thus, the identification feature <NUM> is also useful for determining relative orientation of the access port <NUM> after implantation.

<FIG> shows a cross-sectional view taken at line <NUM>-<NUM> of the access port <NUM> in <FIG>. In this example embodiment, the identification feature <NUM> is disposed beneath the septum <NUM> and the cavity <NUM>. <FIG> further depict enlarged cross-sectional views of potential cut profiles of the recessed identification feature <NUM>. <FIG> shows a rounded engraving profile <NUM>, engraved on the lower surface <NUM> of the base <NUM> and used for purposes of aesthetics and ease of manufacturing. For a relatively more defined contrast under imaging technology, however, a sharp-edged engraving profile <NUM> may be used, as seen in <FIG>. Note that a variety of cross-sectional recessed profiles may be employed. This disclosure further contemplates that although engraving is discussed here, other methods of marking the identification feature may be used, such as milling, machining, chemical or laser etching, molding, stamping, etc..

Regardless of the cut profile used, better contrast is achieved generally with greater engraving depth X. The optimal engraving depth X will depend, however, on the thickness of the overall cavity base <NUM>, which is the portion of the base directly below the cavity <NUM>, as shown in <FIG>. For example, in an embodiment of an access port including titanium, if the overall thickness of the cavity base <NUM> is approximately <NUM>" then sufficient contrast for x-ray imaging purposes can be obtained in one embodiment by engraving the identification feature <NUM> to a depth X (<FIG>) of between about <NUM>" and about <NUM>". In another example embodiment of an access port including titanium, where the overall thickness of the cavity base <NUM> is approximately <NUM>", sufficient contrast can be obtained by engraving the identification feature <NUM> to a depth X of between about <NUM>" and about <NUM>". One of ordinary skill in the art will appreciate that the depth of an engraved identification feature can be varied substantially in order to comply with a product's safety requirements and still remain within the scope contemplated by this disclosure. In addition, the depth X of the identification feature can vary according to the position of the feature on the access port, the thickness of material to be penetrated by the imaging technology, the type of material included in the access port, etc..

It is also contemplated by this disclosure that the use of an identification feature in a metallic or other radiopaque access port can be applied to access ports having a variety of possible configurations, such as is seen in <FIG>, for example. <FIG> depict one embodiment, wherein the access port <NUM> includes an identification feature <NUM> on a lower surface <NUM> of a base or body <NUM>. The access port <NUM> in <FIG> includes a retaining ring <NUM>, which seals the septum <NUM> to the base or body <NUM>, over the cavity <NUM>. In one embodiment, the retaining ring <NUM> is press fit into the base or body <NUM> to hold the septum <NUM> in place. <FIG> show yet another embodiment, wherein the access port <NUM> includes an identification feature <NUM> on the cavity base <NUM> and wherein the cavity base is mated to and flush with a lower surface <NUM> of a cap <NUM> to define a body. In a particular embodiment, the cavity base <NUM> is press fit into the cap <NUM>, though other mating configurations can also be employed.

In another embodiment contemplated by the instant disclosure, <FIG> show that the location of the identification feature <NUM> can vary as well. Rather than placing the identification feature <NUM> under the cavity <NUM>, it is possible to place the identification feature under another portion of the access port <NUM>, such as under the outlet stem <NUM> and between the septum plugs <NUM>, i.e., proximate the outer periphery of the access port bottom surface. Though the overall thickness of the access port structure above the identification feature <NUM> is greater in this location than if engraved under the cavity <NUM>, the change in location allows for a relatively deeper engraving, which will increase contrast without risk of excessive thinning of the cavity base <NUM>. Additionally, in one embodiment, it is possible to define the identification feature compositely by engraving into both the bottom and top surfaces, such that the engravings are vertically aligned. This enables the remaining material thickness to be substantially reduced in order to provide relatively greater radiographic transmission through the identification feature.

Additionally, the instant disclosure contemplates access ports having any variety or combination of desired identification features for indicating power-injectability or other aspect or characteristic of an access port. Specifically, <FIG> depict different types of identification features <NUM>, according to example embodiments. <FIG> depict a symbolic identification feature <NUM>. <FIG> depict an exemplary embodiment of an access port <NUM> including a combination of identification features <NUM>, namely an alphanumeric identification feature 200A and a patterned identification feature 200B. A patterned or symbolic identification feature can also be used to help indicate the orientation of the port or for any other desired reason. It is understood by the instant disclosure that other symbols, patterns, marks, and alphanumeric characters can be used both alone and in any combination with each other on a variety of access port configurations.

In additional embodiments, the identification feature can be defined on an inside bottom surface 36B of the cavity <NUM> of an access port <NUM>, or in addition to the identification feature <NUM> provided on the bottom surface <NUM>. In another embodiment, the material surrounding the defining edges of the desired radiopaque alphanumeric character, symbol, pattern, etc., can be removed instead of removing the desired feature shape itself so as to define a "positive" relief image of the identification feature. Such a positive relief identification feature can be defined on a lower surface of an access port body or on the inside bottom surface of the cavity, for example.

In addition to the various types of symbols, patterns, marks, and alphanumeric characters that are contemplated by the instant disclosure, <FIG> disclose additional example embodiments of identifying features on access ports that are observable via x-ray or other suitable imaging technology. Specifically, the instant disclosure contemplates the use of shelled-out cavities <NUM>, wherein portions of the access port <NUM> are hollowed out. This results in shelled-out cavities <NUM> extending inward from the lower surface <NUM> of the base or body <NUM> or corresponding port lower surfaces of the other embodiments described herein, including the lower surface <NUM> of the base <NUM>, as in FIG. <NUM>, and the lower surface <NUM> of a cap <NUM>, as in <FIG>. This is done by removing the material surrounding the cavity <NUM> without disrupting the cavity periphery 36A or the outer side surfaces <NUM> of the access port <NUM>. As seen in <FIG>, ribs <NUM> may be left to support the remaining "shelled" frame of the access port <NUM>. The definition of such cavities <NUM> provides a relative difference in radiopacity of the access port <NUM> that can be identified via x-ray imaging. As such, the cavities <NUM> can be arranged to define a pattern or to form an indicia for identification of an aspect or characteristic of the access port <NUM>. Note that in other embodiments, the cavities can be defined so as to extend from other surfaces of the access port, including the top and sides thereof.

In a further aspect contemplated by the instant disclosure, it is contemplated that a communicative technology may be utilized wherein information is encompassed by an access port contemplated by the instant disclosure. Generally, a communication device (e.g., a radio beacon, a light-emitting element, an ultrasound emitting transducer, etc.), may be imbedded or otherwise affixed to an access port contemplated by the instant disclosure. Such a communication device may be configured for transmitting information in response to a given impetus. More specifically, the instant disclosure contemplates that an access port contemplated by the instant disclosure may be exposed to a request signal (e.g., a sound, an impact or an acceleration, light, radio waves, etc.). Such a request signal may cause the communication device to transmit information therefrom via sound, light, radio waves, or as otherwise known in the art. Such information may be employed for identifying an access port contemplated by the instant disclosure.

In one exemplary example, it is contemplated that radio frequency identification technology may be employed for identification of an access port contemplated by the instant disclosure. Particularly, so-called active RFID tags are powered by an internal battery and are typically read/write devices. Currently, a suitable cell coupled to suitable low power circuitry can ensure functionality for as long as ten or more years, depending upon the operating temperatures and read/write cycles and usage. So-called passive RFID tags operate without a separate external power source and obtain operating power generated from the reader. Passive RFID tags are typically programmed with a unique set of data (usually <NUM> to <NUM> bits) that cannot be modified. Read-only tags may operate as an identifier comparable to linear barcodes which may contain selected product-specific information. Thus, passive RFID tags may be much lighter than active RFID tags, less expensive, and may offer a virtually unlimited operational lifetime. The tradeoff is that they have shorter read ranges than active tags and require a higher-powered reader.

One advantage of RFID approach is the noncontact, non-line-of-sight nature of the technology. Tags can be read through a variety of substances such as snow, fog, ice, paint, crusted grime, and other visually and environmentally challenging conditions, where other optically read technologies may be less effective. RFID tags can also be read in challenging circumstances at rapid speeds, in most cases responding in less than about <NUM> milliseconds.

Reference is now generally made to <FIG> in describing additional embodiments wherein an access port includes at least one identification feature observable through interaction with an imaging technology, such as x-ray and fluoroscopy, for instance, in order to facilitate identification of at least one attribute, or characteristic, of an access port subsequent to implantation within the body of a patient. It is appreciated that the embodiments to be described can be included alone or together with other identification features described herein and may be employed with access ports having a variety of sizes, shapes, and other variations in configuration. As such, the embodiments described herein are merely examples of the principles of the present disclosure.

<FIG> shows an access port <NUM> including a base <NUM> and a septum <NUM> covering a reservoir defined by the base. The septum <NUM> includes a plurality of palpation bumps <NUM> for enabling external digital palpation and location of the septum by a clinician after the access port <NUM> has been subcutaneously implanted. The port <NUM> includes a retaining ring <NUM> for capturing and retaining the septum <NUM> in place atop the port reservoir. In the present embodiment, both the port base <NUM> and the retaining ring are metallic substance, including titanium for instance, though in other embodiments other suitable materials may be used.

In the present embodiment the retaining ring <NUM> includes an identification feature <NUM> for identifying a predetermined attribute or characteristic of the port <NUM> after implantation thereof. Specifically, the retaining ring <NUM> includes alphanumeric character identification features 200A spelling "POWER INJECTABLE," which indicates that the port <NUM> is capable of power injection. The alphanumeric characters in one embodiment are inset via etching or otherwise suitably defined in the retaining ring <NUM> so as to provide a relative thickness difference between the characters and surrounding metallic retaining ring material, thus providing a corresponding radiographic contrast when the port <NUM> is imaged with x-ray imaging technology. This contrast enables the alphanumeric characters to become visible in an x-ray and therefore discernible by a clinician viewing the x-ray, thus enabling the port attribute or characteristic relating to the identification feature <NUM> to be ascertained.

Note that the alphanumeric identification features 200A can be defined on the retaining ring <NUM> in any number of suitable ways, including etching, engraving, etc., and the characters can be defined partially or completely through the retaining ring. Also, the particular characters or words used can vary from what is described here. Indeed, other characters, patterns, symbols, etc. can be employed in the identification feature <NUM>. Optionally, the identification features can be defined in negative relief, as shown in <FIG>, or in positive relief, if desired.

Additionally, in other embodiments the identification feature of the retaining ring can be configured in other ways according to the configuration of the port. For instance, in embodiments where the port body includes a non-metallic material, the identification feature can include radiopaque ink that is applied to a surface of the retaining ring so as to form the alphanumeric or other characters or features. In yet other embodiments, the identification feature can be included on portions or surfaces of the port in addition to the retaining ring. These and other modifications are therefore contemplated.

<FIG> includes the metallic retaining ring <NUM> of the metallic port <NUM> configured in accordance with another embodiment, wherein the retaining ring defines the identification feature <NUM>, including a plurality of overlapping portions 330A that each overlap a portion of the septum <NUM> retained by the retaining ring. In <FIG>, the overlapping portions 330A of the retaining ring <NUM> cooperate to generally define a triangular shape, which provides a radiographic contrast relative to portions of the metallic port <NUM> below the retaining ring. As before, this provides a corresponding radiographic contrast when the port <NUM> is imaged with x-ray imaging technology, enabling the triangular shape to be discernible as a radiopaque outline by a clinician viewing the x-ray in order to ascertain the predetermined port attribute or characteristic relating to the identification feature <NUM> to be ascertained. In other embodiments, the retaining ring can define other shapes in addition to the triangular shape shown here. Additionally, characters, symbols, or other patterns can be defined in or included on the overlapping portions of the retaining ring if desired.

<FIG> depict various details regarding the inclusion of an identification feature for identifying a predetermined attribute or characteristic of an access port after implantation into a patient. Specifically, these figures depict a dual reservoir access port <NUM>, including a cap <NUM> matable to a base <NUM> and two septa <NUM> interposed between the cap and base. Suture plugs <NUM> are included with the port <NUM>. In accordance with the present embodiment, a bottom surface 416A of the port base <NUM> includes the identification feature <NUM> for identification of the subcutaneously implanted port. As best seen in <FIG>, the identification feature <NUM> in the present embodiment includes a radiopaque marking including the letters "C" and "T" outlined by a double-triangle border, though many different character, pattern, and/or combination configurations are possible. For instance, in addition to identifying the access port as power injectable, this and other identification features described herein can be used to designate lot numbers, hospital identification, port brand, etc..

The radiopaque marking of the identification feature <NUM> can include a metallic powder intermixed with an ink-based marking. Specifically, in one embodiment, the radiopaque marking includes tungsten powder intermixed with <NUM> black wire marking ink manufactured by Gem Gravure, Inc. of West Hanover, MA, in a ratio of three parts tungsten powder to one part ink. Mixing of the two components can include ball mixing to ensure good component integration in one embodiment. Also, additives can be added to the mixture to attain a proper mixture viscosity.

In other embodiments, the powder-to-ink ratio can be modified from that described above, including <NUM>:<NUM>, <NUM>:<NUM>, and <NUM>:<NUM> ratios, for instance. The ideal ratio will vary according to the type of materials employed in the mixture, the density of the desired image, powder particle size, amount of mixture applied to the port, etc. In yet other embodiments, other medical grade inks or suitable liquids, as well as other biocompatible metallic powders or suitable radiopaque materials, could be used. In one embodiment, a ceramic, such as zirconium oxide powder, can be intermixed with a marking ink to provide the radiopaque marking. Ink thinners can also be added to the mixture, along with other suitable substances as appreciated by those skilled in the art.

As shown in <FIG>, the ink-based radiopaque marking that forms the identification feature <NUM> in the present embodiment is included on a substrate <NUM>. In one embodiment, the substrate <NUM> includes a material substantially identical to the material included in the port <NUM>. Specifically, in one embodiment, both the port <NUM> and the substrate <NUM> include an acetyl resin sold under the brand DELRIN®, though it is appreciated that other suitable materials could be used for the substrate and port.

The substrate <NUM> is employed as a base on which the radiopaque marking can be deposited in preparation for integration of the substrate and marking into the port <NUM> during an injection molding process so as to encapsulate the radiopaque marking within the molded port. In detail, in one embodiment, the radiopaque marking, including the above-described ink/powder mixture or other suitable substance, is first deposited on a surface of the substrate <NUM> via any acceptable process, including pad printing, manual or automatic painting, silk screening, use of a template, etc. To improve adhesion of the ink/powder mixture, the substrate can be plasma treated or corona treated in one embodiment.

Once the radiopaque marking has been applied to the substrate <NUM>, the substrate is loaded into a mold, such as that shown in <FIG>, which depicts the substrate positioned within a cavity <NUM> of a portion of a mold <NUM>. The substrate <NUM> is positioned within the mold cavity <NUM> such that the radiopaque marking is facing in toward what will become the center of the port <NUM>. In one embodiment, the substrate <NUM> is held in place within the mold cavity <NUM> via a vacuum assist system; in other embodiments, temporary mechanical fixation can be employed, if necessary. A template including a hole sized to enable the substrate to pass therethrough can be used in one embodiment to assist the technician in placing the substrate <NUM> with the proper orientation within the mold cavity <NUM>.

The port <NUM> is then fabricated by an injection molding process. The substrate <NUM> is thus insert-molded into the port <NUM> via the injection molding process, which bonds the substrate <NUM> to the molded body of the port <NUM>, thus encapsulating the radiopaque marking of the identification feature <NUM> within the port and preventing its inadvertent removal. Additionally, due to the relative thinness of the substrate <NUM>, the identification feature remains visible through the substrate from outside of the port <NUM>, as seen in <FIG>, before implantation. In one embodiment, the thickness of the substrate <NUM> ranges from about <NUM> inch to about <NUM> inch, though other thicknesses can be acceptably used. Later, when the port <NUM> is implanted and imaged under x-ray, the identification feature <NUM> will be visible in the x-ray image and useful to identify an attribute or characteristic of the implanted port.

It is appreciated that in other embodiments, the substrate can be configured to be positioned in other regions of the port. In yet other embodiments, other substrate materials can be used. For instance, in one embodiment the substrate can include woven high-density polyethylene sold under the brand TYVEK®. In this case, the substrate <NUM> does not permanently adhere to the port <NUM> as a result of the insert molding process, but is removed after molding process is complete. The radiopaque marking ink/powder mixture initially included on the woven substrate <NUM>, however, is integrated into the port body and remains with the port <NUM> after molding and substrate removal to serve as the identification feature <NUM>. Flaps or flanges can be included on the substrate to facilitate its separation from the substrate from the port after molding, in one embodiment. In another embodiment, the ink/powder radiopaque marker mixture is allowed to dry on the substrate <NUM> after application thereon to improve adhesion to the port <NUM> during the insert molding process. In addition to those explicitly described here, other suitable materials can be used as the substrate. In yet another embodiment, no substrate is used and the ink/powder radiopaque marker mixture is applied directly to the mold surface before the port <NUM> is molded therein.

<FIG> depict details of the substrate <NUM> and identification feature <NUM> configured in accordance with another embodiment, wherein the substrate forms a portion of the port base. A raised surface 440A is included on the substrate, and a radiopaque marking, such as the intermixed marking ink and radiopaque powder, is included on the raised surface to define the identification feature <NUM>. Application of the radiopaque marking can occur in any one of a number of suitable ways, including contact application by a stamp or tamp pad, ink jet printing, physical or chemical deposition, etc..

The substrate <NUM> with the included identification feature <NUM> can then be inserted into a mold and insert-molded to form part of a base <NUM> of an access port. The radiopaque identification feature <NUM>, now encapsulated within the base, provides the desired identification of a predetermined attribute or characteristic of the port once manufacture of the port is complete.

Reference is now made to <FIG>, which depicts another identification feature for an access port, such as a plastic port for instance, according to one embodiment. In particular, the port <NUM> of <FIG> includes a cavity <NUM> defined on a bottom surface 416A of the port base <NUM>. In one embodiment, the cavity <NUM> is defined to a depth of about <NUM> inch, though other depths can also be used according to desire and port configuration. The cavity <NUM> is filled with a radiopaque fill material <NUM>. The cavity <NUM> is shaped with a predetermined design or configuration so as to form the identification feature <NUM> when filled with the radiopaque fill material <NUM>, thus enabling a predetermined attribute or characteristic of the port <NUM> to be identified via x-ray imaging subsequent to implantation. In the present embodiment, the fill material <NUM> includes tungsten powder intermixed with a two-part silicone sold under the brand SILASTIC® Q7-<NUM>, available from Dow Corning Corporation, Midland, MI in equal quantities, i.e., equal parts of part A silicone, part B silicone, and tungsten powder. Of course, other suitable materials could also be employed. For instance, titanium can be used in place of tungsten, and biocompatible urethane adhesives can be used in place of silicone.

In one embodiment, the fill material <NUM> is injected into the cavity <NUM> by a pressurized syringe, such as an electronic fluid dispenser, though other suitable techniques can also be employed, including manual filling by syringe. Any excess fill material <NUM> can be removed from the port base bottom surface 416A after filling, and the fill material can be allowed to cure. Note that in other embodiments the bottom surface of the port can include other portions of the port in addition or instead of the base, as shown in <FIG>.

<FIG> show details of one embodiment for providing the identification feature <NUM> on a resilient septum <NUM> of an implantable access port, such as a plastic port for instance, wherein the septum includes a radiopaque portion visible under x-ray imaging to provide information relating to an attribute or characteristic of the septum itself and/or the access port in which the septum is disposed. In the illustrated embodiment, the radiopaque portion is defined as an annular portion <NUM> disposed about the upper outer periphery of the septum <NUM> so as not to interfere with puncturing of the septum by needles during port use. As best seen in <FIG>, the annular portion does not extend in depth through the thickness of the septum outer portion, but in other embodiments the thickness, size, and position of the radiopaque portion can vary on the septum.

In the present embodiment, the radiopaque annular portion <NUM> includes barium sulfate-loaded silicone, while the remainder of the septum <NUM> is unloaded silicone. In other embodiments, other suitable radiopaque materials can be employed with silicone or other septum materials. In one embodiment, the septum <NUM> of <FIG> can be formed by a two-part molding process, wherein the annular portion <NUM> is manufactured separately from the rest of the septum <NUM>, then the two parts are adhered together by a suitable adhesive, mechanical fixation, etc., to form the structure shown in <FIG>.

In another embodiment, the present septum <NUM> is manufactured integrally via a co-molding process, wherein separate injection heads are employed in a mold cavity in order to injection mold the annular portion <NUM> with one or more heads and the rest of the septum <NUM> with separate heads. These and other manufacturing methods are therefore considered within the scope of the present disclosure.

The principles discussed in connection with <FIG> can be expanded in one embodiment shown in <FIG>, wherein a port <NUM> including resilient suture plugs <NUM> disposed in corresponding suture plug holes <NUM> is configured such that the suture plugs include a radiopaque material, such as the barium sulfate-loaded silicone employed in the septum <NUM> of <FIG> or other suitable radiopaque material. So configured, the suture plugs provide the identification feature <NUM> that is visible under x-ray imaging to provide information relating to an attribute or characteristic of the port <NUM>. In one embodiment, the port <NUM> can include both the radiopaque suture plugs <NUM> and the septum <NUM> including the radiopaque portion <NUM> in order to provide additional identification ability and/or to provide information relating to the orientation of the port within the body of the patient. In addition to barium sulfate, the suture plugs can include tungsten, tantalum, or other suitable radiopaque materials. In yet another embodiment, one or more radiopaque beads can be disposed in the port body to provide similar port visibility under x-ray.

In one embodiment, the septum, suture plugs, or other portion of the port can include an ultraviolet light-sensitive material. The ultraviolet light-sensitive material can be applied to the surface of the port component or can impregnated into the component. After implantation of the port, ultraviolet light is directed through the skin of the patient to be incident on the ultraviolet light-sensitive material of the port, which causes the material to fluoresce with visible light that is observable through the skin of the patient, thus identifying the port and/or its predetermined attribute or characteristic.

It is appreciated that a radiopaque identification feature can be included or associated with a port in other ways in addition to those embodiments already described. Examples of this can be found in the embodiments depicted in <FIG>. In <FIG>, for example, an identifier tag <NUM> is shown, including a ring portion <NUM> with a slit <NUM> for enabling the identifier ring to be attached to a catheter that is operably attached to the stem of a port. The identifier tag <NUM> further includes a face portion <NUM> on which a radiopaque identification feature <NUM> can be placed for visibility via x-ray imaging to identify a predetermined attribute or characteristic of the port. The tag can be designed in various different shapes and configurations. For instance, the tag can be included as part of a catheter securement device for locking an end of a catheter to the stem of the port.

In <FIG>, the port <NUM> is shown with a catheter securement device <NUM> that is used to secure the connection between an end of a catheter <NUM> and a stem <NUM> of the port. A body <NUM> of the catheter securement device <NUM> is configured to include the identification feature <NUM> for visibility via x-ray imaging to identify a predetermined attribute or characteristic of the port to which the device is attached. Again, the shape, size, and particular configuration of the catheter securement device and identification feature can vary from what is shown and described herein.

In <FIG>, the port <NUM> is shown with the catheter <NUM> operably attached thereto. The catheter <NUM> includes two flaps <NUM> that extend from the body thereof, on which the identification feature <NUM> is included in order to provide a visible identification of a predetermined attribute or characteristic of the catheter and/or port when imaged under x-ray. Of course, the particular identification feature, as well as the number and size/configuration of the catheter flaps can vary from what is described herein.

<FIG> depict yet another example of a radiopaque identification feature wherein the identification feature <NUM> is included in an insert <NUM> formed from a radiopaque material, such as tungsten or other suitable material. The insert <NUM> is suitable for placement in a plastic or other radiotranslucent port such that the insert is visible under x-ray imaging to identify an attribute or characteristic of the port. Orientation arrows <NUM> provide useful indicia of the orientation of the port. By examining the direction of the arrows <NUM>, a clinician observing an x-ray image of the port insert <NUM> can determine whether the port is flipped in the body of the patient. In addition to these, other indicia indicating port orientation can be included on the insert in other embodiments.

<FIG> show implementation of another example of a radiopaque insert, in addition to that shown in <FIG>, which is included to serve as the identification feature <NUM> for identifying a predetermined attribute or characteristic of a port, including a plastic port, as in the present embodiment. In particular, a radiopaque insert <NUM> is shown, configured to be interposed between a cap <NUM> and a base <NUM> of a port <NUM>. Note that, though the insert <NUM> shown here is configured to fit over a dual fluid cavity <NUM> of the port <NUM>, other inserts including a variety of radiopaque compositions can be configured to be included in other ways with a port. Additionally, the port can define one, two, or more fluid cavities covered by septa <NUM>, without limitation.

As shown in <FIG>, the insert <NUM> fits over the fluid cavities <NUM> of the port <NUM> so as to rest on a portion of the port base <NUM>. So positioned, the insert <NUM> is sandwiched and secured between the base <NUM> and the cap <NUM> when the base and cap are mated together to form the port <NUM>. Such mating can be accomplished by ultrasonic welding, adhesives, etc. The resulting interposition of the insert <NUM> between the base <NUM> and cap <NUM> is shown in <FIG>. When the port <NUM> is later imaged via x-ray after patient implantation, the insert <NUM> is readily visible, thus enabling the predetermined attribute/characteristic(s) of the port to be identified.

Claim 1:
An access port (<NUM>) for providing subcutaneous access to a patient, comprising:
a body (<NUM>) defining a fluid cavity (<NUM>) accessible via a septum (<NUM>); and
a metallic retaining ring (<NUM>) that secures the septum (<NUM>) to the body (<NUM>), the metallic retaining ring (<NUM>) including an identification feature (<NUM>) observable via x-ray imaging technology, the identification feature conveying information indicative of at least one attribute of the access port (<NUM>), wherein the identification feature includes a plurality of alphanumeric and/or symbolic characters defined in a surface of the metallic retaining ring (<NUM>).