Port identification insert and method

The subcutaneous access port design with a radiation optic marker securely fitted into a concave portion on the base addresses assembly issues and enables accurate medical imaging by ensuring correct orientation and smaller marker sizes.

JP2025502428APending Publication Date: 2025-01-24BARD PERIPHERAL VASCULAR INC
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Patent Information

Application Number
JP2024543142
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2022-01-21
Publication Date
2025-01-24

AI Technical Summary

Technical Problem

Existing identification markers for subcutaneous access ports can be incorrectly assembled, leading to confusion and misidentification during medical imaging, and are often larger than the smallest size that can be identified under medical imaging.

Method used

A subcutaneous access port design featuring a base with a riser part, a nose portion, and a radiation optic marker that fits into a concave portion on the base, secured by adhesives, welding, or snap-fit engagements, ensuring correct orientation and smaller size for accurate imaging.

Benefits of technology

The design ensures correct assembly and visualization of the port's position and direction under medical imaging, reducing confusion and allowing for smaller marker sizes that can be accurately identified.

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Abstract

The embodiments disclosed herein are directed to a subcutaneous access port including an identification insert or marker that is visible under medical imaging. The outer periphery of the marker can define an alphanumeric symbol to indicate a characteristic of the port. Additionally, the marker can indicate a location or orientation of the port. The marker can be received within the recess, and the shape of the recess is configured to receive the marker in a first orientation. In one embodiment, the shape of the marker and recess is configured to prevent the marker from engaging the recess in a second orientation. This can prevent the port from being assembled if the marker is incorrectly coupled to the port. The port may further include a cover plate for securing the marker within the recess. The bottom surface of the cover plate can match the bottom surface of the port when engaged with the port.
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Description

[Technical field]

[0001] Briefly summarized, embodiments disclosed herein are directed to identification inserts, or markers, for subcutaneous access ports and associated methods of manufacture. [Background technology]

[0002] A subcutaneous vascular access device, or "port," may include an identification marker assembled with the device and configured to be visualized under one or more medical imaging (e.g., x-ray, fluoroscopy, ultrasound, MRI, CT, etc.) when the port is positioned subcutaneously. The marker may indicate characteristics of the port to a user as well as indicate the location and orientation of the port to facilitate access to the port. A variety of identification inserts or markers have been developed that match the septum of the device to indicate the target location. Other port designs include an identification insert or marker located in a nose portion that is positioned opposite the stem portion so as not to be obscured when accessing the septum. Some identification markers, referred to as "positive" markers, include an insert having a perimeter edge that defines a symbol that can be identified under medical imaging, e.g., an alphanumeric symbol, an icon, etc. In contrast, a "negative" identification marker may include a plate or disk that includes an opening extending therethrough. The perimeter of the opening may define a shape or symbol (e.g., "CT") that is identifiable under medical imaging. Summary of the Invention [Problem to be solved by the invention]

[0003] However, some of these identification markers may be assembled incorrectly to the port. Thus, when imaging the subcutaneous port under medical imaging, the identification marker will appear to indicate that the port is inverted or incorrectly placed when the port is correctly placed. This can cause unnecessary confusion and hassle for the patient in resolving the problem. Furthermore, the outer dimensions of the "negative" identification marker are required to be larger than the minimum symbol size identifiable under medical imaging. Disclosed herein are devices and methods that address the above. [Means for solving the problem]

[0004] Disclosed herein is a subcutaneous access port including a base defining a reservoir and optionally having a nose (further optionally extending longitudinally), a stem in fluid communication with the reservoir and extending from the base (optionally longitudinally and / or opposite the nose), a first recess in a bottom surface of the base (disposed on the bottom surface), a radiopaque marker, an outer periphery of the radiopaque marker defining a marker symbol and conforming to the shape of the first recess, whereby the radiopaque marker is configured to fit within the first recess (in a first orientation), and a cover plate disposed over and / or covering the first recess and coupled to the base to secure the radiopaque marker within the first recess.

[0005] In some embodiments, in a transverse direction perpendicular to the longitudinal direction, the radiopaque marker defines a transverse height and the first recess defines a transverse depth that is greater than or equal to the transverse height of the radiopaque marker.

[0006] In some embodiments, the first recess is located in a bottom surface of the nose portion of the base. In some embodiments, the cover plate extends under a portion of the base that is disposed transversely below the reservoir, and / or the cover plate is at least partially received within the base and coupled to the base using one of an adhesive, bonding, or welding.

[0007] In some embodiments, the base further includes a lip extending circumferentially around the first recess and configured to engage the cover plate in one of an interference fit, a press fit, or a snap fit engagement.

[0008] In some embodiments, a lip extends transversely downward from the bottom surface of the base to secure the cover plate over the first recess. In some embodiments, the lip extends transversely upwardly from a bottom surface of the base into the base to define a second recess, the first recess is disposed within the second recess, and the cover plate is configured to fit within the second recess.

[0009] In some embodiments, the peripheral shape of the lip matches the peripheral shape of the cover plate, and in a transverse direction perpendicular to the longitudinal direction, the transverse depth of the lip is equal to or greater than the transverse height of the cover plate.

[0010] In some embodiments, the coverplate includes a coverplate symbol disposed thereon, the coverplate symbol optionally matching that of the marker symbol.

[0011] In some embodiments, the marker symbol indicates a characteristic of the port. In some embodiments, the marker symbol includes one or more of the letter "C," the letter "T," and / or a combined symbol representing the letters "CT."

[0012] In some embodiments, the reservoir is disposed along the longitudinal axis / direction between the stem and the radiopaque marker. In some embodiments, the port further includes a septum located on the reservoir and a cap configured to engage the base to secure the septum to the base.

[0013] Also disclosed herein is a method of manufacturing a subcutaneous access port, comprising: providing a base defining a reservoir and optionally including a nose portion (optionally extending longitudinally), the base including a stem extending from the base (optionally longitudinally and / or opposite the nose portion); providing, optionally forming, a radiopaque marker whose periphery defines a marker symbol; and disposing the radiopaque marker in a first orientation within a first recess in a bottom surface (located in the bottom surface) of the base, optionally of the nose portion, the shape of the recess being configured to prevent the radiopaque marker from engaging the recess in a second orientation different from the first orientation.

[0014] In some embodiments, in a transverse direction perpendicular to the longitudinal direction, the radiopaque marker defines a first transverse height and the first recess defines a first transverse depth equal to the first transverse height of the radiopaque marker.

[0015] In some embodiments, securing the radiopaque marker within the first recess comprises one or more of a press fit, an interference fit, a snap fit engagement, an adhesive, bonding, and welding.

[0016] In some embodiments, securing the radiopaque marker within the first recess includes coupling a cover plate to the base using one or more of a press fit, an interference fit, a snap fit engagement, an adhesive, bonding, and welding, wherein the cover plate extends over or covers the first recess.

[0017] In some embodiments, a portion of the cover plate extends beneath the reservoir, beneath a portion of the base, and / or at least a portion of the cover plate is received within the base.

[0018] In some embodiments, the first recess is disposed within a second recess disposed in the bottom surface of the base, and the cover plate is configured to fit within the second recess. In some embodiments, the coverplate includes a coverplate symbol disposed thereon, the coverplate symbol optionally matching that of the marker symbol.

[0019] In some embodiments, the marker symbol includes a combined symbol representing the letter "C," the letter "T," or the letter "CT" to indicate a characteristic of the port. In some embodiments, the method comprises manufacturing an access port as described herein.

[0020] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. It should also be understood that a specific embodiment disclosed herein may have features that can be easily separated from the specific embodiment and that can be optionally combined or substituted with features of any of the other embodiments disclosed herein. [Brief description of the drawings]

[0021] [Figure 1A] 1 illustrates a perspective top view of a port including an identification marker according to an embodiment disclosed herein. [Figure 1B] 1 illustrates a perspective bottom view of a port including an identification marker according to an embodiment disclosed herein. [Diagram 2] 1 illustrates an exploded bottom view of a port including an identification marker according to an embodiment disclosed herein. [Diagram 3] 1 shows a cross-sectional view of a nose portion of a port including an identification marker according to an embodiment disclosed herein. [Figure 4A] 1 illustrates an exploded bottom view of a port including an identification marker according to an embodiment disclosed herein. [Figure 4B] 4B is a cross-sectional view of a portion of the port of FIG. 4A according to an embodiment disclosed herein. [Figure 5A] 1 illustrates a bottom view of an identification marker according to an embodiment disclosed herein. [Figure 5B] 1 shows a top view of an identification marker according to an embodiment disclosed herein. [Figure 5C] 1 shows a perspective view of an identification marker according to an embodiment disclosed herein. [Figure 5D] FIG. 5D shows a side view of the identification marker of FIG. 5C according to an embodiment disclosed herein. [Figure 5E] FIG. 5D shows a side view of the identification marker of FIG. 5C according to an embodiment disclosed herein. [Figure 5F] FIG. 5D shows a side view of the identification marker of FIG. 5C according to an embodiment disclosed herein. [Figure 5G] FIG. 5D shows a side view of the identification marker of FIG. 5C according to an embodiment disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0022] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts presented herein. It should also be understood that a specific embodiment disclosed herein may have features that can be easily separated from the specific embodiment and that can be optionally combined or substituted with features of any of the other embodiments disclosed herein.

[0023] With regard to the terms used herein, it should also be understood that each term is intended to describe certain embodiments and does not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps among a group of features or steps, and do not impose any order or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in this order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Designations such as "left", "right", "up", "down", "front", "rear", etc. are used for convenience and do not imply any particular fixed position, orientation, or direction, for example. Rather, such designations are used to indicate relative positions, orientations, or directions, for example. Unless the context clearly indicates otherwise, the singular forms "a", "an", and "the" include the plural.

[0024] In the following description, the terms "or" and "and / or" as used herein should be interpreted to include or mean any one or any combination. For example, "A, B, or C" or "A, B, and / or C" means "any of A, B, C, A and B, A and C, B and C, A, B and C." Exceptions to this definition occur only when elements, components, features, steps or actions are in some way inherently mutually exclusive.

[0025] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter. However, the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0026] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, a "distal end" of a catheter includes an end of the catheter that is intended to be near or within a patient when the catheter is used with a patient. A distal portion, end portion, or length of a catheter can include the distal end of the catheter. However, a distal portion, end portion, or length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, a distal portion, end portion, or length of a catheter is not a terminal portion or length of the catheter.

[0027] To aid in describing the embodiments disclosed herein, as shown in Figures 1A and 1B, a longitudinal axis extends substantially parallel to the axial length of the port stem. A transverse axis extends perpendicular to the longitudinal axis, and a transverse axis extends perpendicular to both the longitudinal and transverse axes. A horizontal plane is defined by the longitudinal and transverse axes. A vertical plane extends perpendicular to the horizontal axis.

[0028] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. 1A and 1B show an exemplary subcutaneous access device or "port" 100. FIG. 1A shows a top perspective view of the port 100. FIG. 1B shows a bottom perspective view of the port 100. The port 100 may generally include a base 110 that defines a reservoir 112 and includes a stem 140 extending along a longitudinal axis from the reservoir 112. The stem 140 may define a stem lumen in fluid communication with the reservoir 112. A needle-penetrable septum 130 may be disposed over the reservoir 112 and secured in place by a cap 120. The septum 130 may be formed from silicone rubber or a similar suitable material. In use, when the port 100 is positioned subcutaneously, the top surface of the port 100 is positioned adjacent to the skin surface. A user may pierce the skin with an access needle (not shown) and pierce the septum 130 to access the reservoir 112.

[0029] The cap 120 may engage with the base 110 with an ultrasonic bond, a press fit, an interference fit, or a snap fit engagement. In one embodiment, the cap 120 may be secured to the base 110 using adhesives, bonding, welding, ultrasonic bonding, or a similar suitable method. In one embodiment, the cap 120 may be overmolded onto the base 110. In one embodiment, the cap 120 and the base 110 may be formed as a single monolithic piece formed from the same material.

[0030] In one embodiment, the base 110 may be formed from a substantially rigid or elastic material, including but not limited to, plastic, polymer, thermoplastic, metal, alloy, composite, or combination thereof. In one embodiment, the cap 120 may be formed from a material that is more flexible than the base 110, including but not limited to, plastic, polymer, thermoplastic, elastomer, rubber, silicone rubber, metal, alloy, composite, or combination thereof. In one embodiment, the base 110 and the cap 120 may be formed from the same material and exhibit the same mechanical properties. In one embodiment, the catheter 90 may engage with the stem 140 in one of a press-fit or interference fit engagement. Optionally, a catheter lock 142 may engage with one or both of the catheter 90 and the stem 140 to further secure the catheter 90 to the stem 140.

[0031] In one embodiment, the port 100 may include a nose portion 102. The nose portion 102 extends from the port 100 along a longitudinal axis and is disposed opposite the stem 140 across a central transverse axis of the reservoir 112. The nose portion 102 may define a substantially wedge-shaped profile extending from the port 100. In one embodiment, the nose portion 102 may be configured to facilitate subcutaneous placement of the port 100. For example, when the port 100 is urged subcutaneously, the nose portion 102 may facilitate separating subcutaneous tissue to form a tissue pocket.

[0032] In one embodiment, the nose portion 102 may include a symbol 104 configured to indicate a feature of the port 100, such as, for example, an alphanumeric symbol, shape, or icon. For example, as shown in FIG. 1B, the bottom surface of the base 110 or the cover plate 160 may include a symbol 104, such as the letters "CT," designed to indicate a feature of the port 100, such as that the port 100 is configured for high pressure injection. These and other features of the port 100, including manufacturer, model, part number, serial number, website address, bar code, QR code, or combinations thereof, are contemplated to fall within the scope of the present invention. The symbol 104 may be printed, embossed, or engraved on or into the base 110 or cover plate 160 and may be directly observable by a user to visually indicate one or more features of the port 100. The port 100 may include, but is not limited to, one or more symbols 104 disposed on one or more surfaces of the port 100.

[0033] FIG. 2 illustrates an exploded view of the port 100, generally including a port base 110, an identification insert or marker ("marker") 150, and a cover plate 160. In one embodiment, a bottom surface of the base 110 may include a recess 122 disposed in the nose 102 of the port 100 and extending in a horizontal plane. The recess 122 may also extend in a transverse direction to define a first depth (d1). In one embodiment, a perimeter 124 of the recess 122 may define a curved or polygonal shape extending in a horizontal plane. As illustrated, the perimeter 124 may define a shape that corresponds to the shape of the outer periphery of the marker 150. However, it should be understood that other curved or polygonal shapes are contemplated.

[0034] In one embodiment, the shape of the perimeter 124 of the recess 122 may be the same as or larger than the perimeter 154 of the marker 150. Thus, the marker 150 may be slidably engaged with the recess 122. In one embodiment, the marker 150 may be secured within the recess 122 using adhesives, bonding, welding, or the like. In one embodiment, the shape of the perimeter 124 of the recess 122 may be the same as or slightly smaller than the perimeter 154 of the marker 150. Thus, the marker 150 may engage with the recess 122 in one of an interference fit, a press fit, or a snap fit engagement. In one embodiment, the depth (d1) of the recess 122 may be the same as or larger than the transverse height (h1) of the marker 150. Thus, the marker 150 may be configured to fit within the recess 122. In one embodiment, the transverse height (h1) of the marker 150 may be between 0.20 and 0.60 inches. However, larger or smaller dimensions are also contemplated as falling within the scope of the present invention.

[0035] In one embodiment, the port 100 includes one or more recesses 122, each configured to receive a marker 150. For example, as shown in FIG. 2, a first recess 122A defines a "C" shape configured to receive a first marker 150A that defines a "C" shape. Additionally, a second recess 122B defines a "T" shape configured to receive a second marker 150A that defines a "T" shape. However, other shaped recesses 122 and markers 150 are contemplated, including different shapes and alphanumeric symbols, etc. In one embodiment, the alphanumeric shapes (i.e., "C" and "T" shapes) may correspond to a font size between 10 pt. and 16 pt. However, larger or smaller font sizes are also contemplated.

[0036] The markers 150 may be formed from a radiopaque material configured to be visualized when imaged by one or more medical imaging techniques. Exemplary medical imaging techniques may include, but are not limited to, x-ray, fluoroscopy, ultrasound, magnetic resonance imaging (MRI), computed tomography (CT), positron emission tomography (PET), or combinations thereof.

[0037] In one embodiment, the port 100 further includes a cover plate 160 configured to be disposed over the recess 122 and secure the marker 150 within the recess 122. In one embodiment, the cover plate 160 may be secured to the base 110 using adhesives, bonding, welding, or similar suitable means. In one embodiment, the base 110 may include a lip 114 extending circumferentially around at least a portion of the recess 122. A periphery 164 of the cover plate 160 may engage the lip 114 in one of an interference fit, a press fit, or a snap fit engagement to secure the cover plate 160 to the base 110. In one embodiment, as shown in FIGS. 4A and 4B, the lip 114 may extend transversely downward from a bottom surface of the base 110 to secure the cover plate 160 over the recess 122.

[0038] In one embodiment, as shown in FIG. 2, the lip 114 may extend transversely upward into the bottom surface of the base 110 to secure the cover plate 160 over the recess 122. In other words, the lip 114 extending upward into the base 110 may define a second recess, with the first recess 122 disposed within the second recess. The first recess 122 is configured to receive the marker 150 and the second recess is configured to receive the cover plate 160. In one embodiment, the lip 114 may extend transversely with a depth (d2). The depth (d2) may be the same as or greater than the thickness (h2) of the cover plate 160. In one embodiment, the thickness (h2) of the cover plate 160 may be 0.05 to 0.6 inches. However, larger or smaller dimensions are contemplated to fall within the scope of the present invention. In one embodiment, the bottom surface of the cover plate 160 may coincide with the bottom surface of the base 110 when the cover plate 160 is engaged with the second recess to provide a continuous bottom surface of the port 110 .

[0039] Figure 3 shows a cross-sectional view of the nose 102 of the port 100, including one or more markers 150 disposed within the one or more recesses 122 and a cover plate 160 disposed over the recesses 122. Figure 3 shows the lip 114 extending transversely upwardly into the base 110. The cover plate 160 is thus received within a second recess defined by the lip 114 such that a bottom surface of the cover plate 160 coincides with a bottom surface of the base 110.

[0040] In one embodiment, as shown in FIG. 4A , the recess 122 may extend transversely upward into the base 110 from a bottom surface of the base 110. The cover plate 160 may extend over the recess 122 and may extend over at least a portion of the bottom surface of the base 110 transversely below the reservoir 112. The cover plate 160 may be secured to the base 110 using adhesives, bonding, welding, etc., as described herein. Advantageously, the cover plate 160 secures the marker 150 within the recess 122 and also provides additional reinforcement to the base 110 below the reservoir 112, thereby inhibiting an access needle from penetrating the base 110 when accessing the reservoir 112.

[0041] 5A-5G show various views of one embodiment of the marker 150. FIG. 5A shows a bottom view. FIG. 5B shows a top view. FIG. 5C shows a perspective view of the marker 150. FIG. 5D-5G show side views of the marker 150 shown in FIG. 5C. In one embodiment, the perimeter 154 of the marker 150 may define a shape resembling two or more alphanumeric symbols. The two or more alphanumeric symbols are coupled together such that a single monolithic marker 150 may define two or more alphanumeric symbols that are identifiable when imaged under medical imaging. In one embodiment, the shape of the perimeter 124 of the recess 122 may match the shape of the perimeter 154 of the marker 150 such that the marker 150 can be received within the recess 122. Additionally, the recess 122 and marker 150 may be configured such that the marker 150 is receivable within the recess 122 in a first orientation in Cartesian space, but is not receivable within the recess 122 in a second orientation different from the first orientation in Cartesian space. Advantageously, the marker 150 can only be installed in the port 100 in the first orientation, and cannot be installed in the port in the second, or incorrect, orientation. Thus, the correct orientation of the port 100 is indicated when the port is imaged using medical imaging techniques.

[0042] As will be appreciated, the marker 150 formed from a radiopaque material contrasts with the surrounding radiolucent material. Thus, as described herein, the periphery 154 of the marker 150 can define a symbol when imaged under medical imaging techniques. The marker symbol can indicate one or more characteristics of the port 100 and / or the location or orientation of the port 100 when imaged subcutaneously. When the periphery 154 of the marker 150 can define a symbol, the marker 150 may be referred to as a "positive" image marker. This is in contrast to a "negative" marker that includes an opening or "punch-out," where the shape of the punch-out defines the symbol. Advantageously, a positive marker can define a smaller sized symbol and can be attached to a smaller port 100. In other words, a positive marker requires a smaller overall footprint of the marker 150 compared to a negative marker that defines the same sized symbol. Thus, the positive marker 150 can be attached to smaller devices such as the port 100 .

[0043] In one embodiment, the recess 122 may be disposed on a portion of the cap 120. A portion of the base 110 may extend over at least a portion of the recess 122. Thus, with the marker 150 disposed in the recess, the base 110 may secure the marker 150 in the recess 122 in a first orientation. In one embodiment, a portion of the base 110 may extend over the entire recess 122 to seal the marker 150 in the recess 122. The base 110 may be attached to the cap 120 using adhesives, bonding, welding, or similar suitable means. As will be appreciated, if the marker 150 is disposed in the recess 122 in a second orientation different from the first orientation, the marker 150 will not match the recess 122 and will not be fully received within the recess 122, preventing the base 110 from fully engaging the cap 120. Advantageously, the marker 150 is configured to prevent the port 100 from being assembled incorrectly.

[0044] In one embodiment, the symbol 104 disposed on the underside of the cover plate 160 or base 110 may be aligned with a positive symbol defined by the marker 150. Thus, the symbol 104 may provide a visual representation of the symbol defined by the marker 150 disposed within the recess 122. In one embodiment, one or more of the cover plate 160, base 110, and cap 120 may be formed from an opaque material. Thus, the marker 150 may not be directly observable once installed within the port 100.

[0045] In one embodiment, as shown in FIGS. 1-4 , the symbol 104 may include an alphanumeric symbol engraved in reverse on the cover plate 160 or the bottom surface of the base 110 to align with the symbol defined by the marker 150. Thus, the symbol 104 may visually communicate the orientation of the marker 150 within the recess 122. During subcutaneous placement of the port 100, a user may view the symbol 104 to verify that the marker 150 is correctly positioned. In one embodiment, the base may include a first symbol configured to align with the marker 150 positioned within the recess 122. As described herein, the base 110 may further include a second symbol (not shown) and may be configured to communicate a second characteristic of the port 100, such as, for example, a manufacturer, model, part number, or serial number.

[0046] In one embodiment, one or more of the cover plate 160, base 110, or cap 120 may be formed from a transparent or translucent material such that a user may directly observe the marker 150 disposed within the recess 122 when the port 100 is assembled. In one embodiment, one or more of the cover plate 160, base 110, or cap 120 may include a window such that a user may directly observe the marker 150 disposed within the recess 122 when the port 100 is assembled. The window is formed from a transparent or translucent material and is aligned with the recess 122. Advantageously, one or more of the cover plate 160, base 110, or cap 120 may cooperate to provide a smooth profile and contain the marker 150 therein to prevent any tissue from ingrowing into the opening 152 when the port 100 is placed subcutaneously.

[0047] Some specific embodiments are disclosed herein, and although the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concept provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and the broader aspects also encompass these adaptations and / or modifications. Thus, one may deviate from the specific embodiments disclosed herein without departing from the scope of the concept provided herein.

Claims

1. a base defining a reservoir and having a longitudinally extending nose portion; a stem in fluid communication with the reservoir and extending from the base opposite the nose; A first recess disposed on a bottom surface of the base; a radiopaque marker, an outer periphery of the radiopaque marker defining a marker symbol and conforming to a shape of the first recess, whereby the radiopaque marker is configured to fit within the first recess in a first orientation; a cover plate disposed over the first recess and coupled to the base to secure the radiopaque marker within the first recess.

2. The subcutaneous access port of claim 1 , wherein the radiopaque marker defines a transverse height and the first recess defines a transverse depth that is greater than or equal to the transverse height of the radiopaque marker.

3. The subcutaneous access port of claim 1 or 2, wherein the first recess is disposed in the bottom surface of the nose portion of the base.

4. The subcutaneous access port of any one of claims 1 to 3, wherein the cover plate extends under a portion of the base that is disposed transversely below the reservoir and is coupled to the base using one of an adhesive, a bond, or a weld.

5. The subcutaneous access port of any one of claims 1 to 4, wherein the base further includes a lip extending circumferentially around the first recess and configured to engage the cover plate in one of an interference fit, a press fit, or a snap fit engagement.

6. The subcutaneous access port of claim 5 , wherein the lip extends transversely downward from the bottom surface of the base to secure the cover plate over the first recess.

7. 6. The subcutaneous access port of claim 5, wherein the lip extends transversely upward from the bottom surface of the base into the base to define a second recess, the first recess is disposed within the second recess, and the cover plate is configured to fit within the second recess.

8. A subcutaneous access port according to any one of claims 5 to 7, wherein the peripheral shape of the lip matches the peripheral shape of the cover plate and the transverse depth of the lip is greater than or equal to the transverse height of the cover plate.

9. The subcutaneous access port of any one of claims 1 to 8, wherein the cover plate includes a cover plate symbol disposed thereon, the cover plate symbol matching that of the marker symbol.

10. The subcutaneous access port of any one of claims 1 to 9, wherein the marker symbol indicates a characteristic of the port.

11. The subcutaneous access port of any one of claims 1 to 10, wherein the marker symbol includes one or more of the letter "C", the letter "T", or a combined symbol representing the letters "CT".

12. The subcutaneous access port of any one of claims 1 to 11, wherein the reservoir is disposed along a longitudinal axis between the stem and the radiopaque marker.

13. The subcutaneous access port of any one of claims 1 to 12, wherein the port further comprises a septum located on the reservoir and a cap configured to engage the base to secure the septum to the base.

14. providing a base defining a reservoir and including a longitudinally extending nose portion, the base including a stem extending from the base opposite the nose portion; forming a radiopaque marker having a periphery defining a marker symbol; disposing the radiopaque marker in a first orientation within a first recess disposed in a bottom surface of the nose portion, the shape of the recess being configured to prevent the radiopaque marker from engaging the recess in a second orientation different from the first orientation; and fixing the radiopaque marker within the recess.

15. 15. The method of claim 14, wherein the radiopaque marker defines a first transverse height and the first recess defines a first transverse depth equal to the first transverse height of the radiopaque marker.

16. 16. The method of claim 14 or 15, wherein fixing the radiopaque marker within the first recess comprises one or more of a press fit, an interference fit, a snap fit engagement, an adhesive, bonding, and welding.

17. 17. The method of any one of claims 14 to 16, wherein fixing the radiopaque marker within the first recess comprises coupling a cover plate to the base using one or more of a press fit, an interference fit, a snap fit engagement, an adhesive, bonding, and welding, the cover plate extending over the first recess.

18. The method of claim 17 , wherein a portion of the cover plate extends beneath the reservoir and beneath a portion of the base.

19. 19. The method of any one of claims 14 to 18, wherein the first recess is disposed within a second recess disposed in the bottom surface of the base, and the cover plate is configured to fit within the second recess.

20. A method according to any one of claims 14 to 19, wherein the coverplate includes a coverplate symbol disposed thereon, the coverplate symbol matching that of the marker symbol.

21. The method of any one of claims 14 to 20, wherein the marker symbols include a combined symbol representing the letter "C", the letter "T", or the letter "CT" to indicate a characteristic of the port.

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