Port Identification Inserts and Assembly Alignment Features

Abstract

The embodiments disclosed herein relate to an identification insert and assembly alignment feature for a subcutaneous access port. The port may include an identification insert that is incorporated into the device and configured to be observable under medical imaging when placed subcutaneously. The insert may indicate characteristics of the port and an orientation or location of the port to facilitate access to the port. The alignment feature may be configured to align the insert with the port in a first orientation during manufacturing. The alignment feature may also be configured to misalign the insert from the port in a second orientation different from the first orientation. This prevents the port from being assembled if the insert is incorrectly coupled with the port. A port with an incorrectly incorporated insert may cause unnecessary confusion and hassle for the patient in resolving the problem.

Description

[Technical field]

[0001] Briefly summarized, the embodiments disclosed herein are directed to an identification insert or marker for a subcutaneous access port and assembly alignment feature. [Background technology]

[0002] Subcutaneous vascular access devices or "ports" can include an identification marker that is assembled to the device and designed to be visible under one or more medical imaging techniques (e.g., x-ray, fluoroscopy, ultrasound, MRI, CT, etc.) when the port is placed subcutaneously. The marker can indicate characteristics of the port to the user and can indicate the location and orientation of the port to facilitate access to the port. Various identification inserts have been developed that are aligned with the septum of the device to indicate the target location. Other port designs include an identification insert located in the nose portion located opposite the stem portion so as not to be obscured when accessing the septum. Summary of the Invention [Problem to be solved by the invention]

[0003] However, some of these identification markers may be incorrectly assembled 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. Disclosed herein are devices and methods that address the above. [Means for solving the problem]

[0004] The following items also define the invention: Disclosed herein is a subcutaneous access port including a base defining a reservoir, a stem in fluid communication with the reservoir and extending longitudinally, a septum disposed at least partially on the reservoir, a cap configured to engage the base and secure said septum on said reservoir, the cap including a nose portion (optionally opposite the stem) defining a recess, an alignment feature including a protrusion extending from a surface / periphery / edge of the recess into the recess (and for aligning the cap and the radiopaque insert), and a radiopaque insert including an opening. The periphery of the opening defines a symbol. The radiopaque insert is configured to fit within said recess in a first orientation. The access port, and in particular the radiopaque insert, are configured so that a protrusion maintains the radiopaque insert in the first orientation and prevents the radiopaque insert from engaging the recess in a second orientation that is different from the first orientation.

[0005] In some embodiments, the base engages the cap to secure the radiopaque insert within the recess in a first orientation. In some embodiments, one of the projection or the base abuts the radiopaque insert in the second orientation to prevent the cap from engaging the base.

[0006] In some embodiments, the protrusion engages with a notch disposed on a periphery of the radiopaque insert in a first orientation, and the access port is configured such that in a second orientation, the notch abuts a portion of the periphery of the radiopaque insert.

[0007] In some embodiments, the protrusion is configured to engage an opening in the radiopaque insert in a first orientation and abut a portion of the radiopaque insert in a second orientation.

[0008] In some embodiments, the symbol indicates a characteristic of the port. In some embodiments, the symbol includes the letters "CT." In some embodiments, the insert is disposed along the longitudinal axis on an opposite side of the reservoir from the stem.

[0009] In some embodiments, the reservoir is disposed along the longitudinal axis between the stem and the insert. In some embodiments, the nose extends from the port along the longitudinal axis opposite the stem.

[0010] Also disclosed is a method of making a subcutaneous access port that includes providing a cap including a nose portion defining a recess; placing a radiopaque insert including an opening, the periphery of the opening defining a symbol, within the recess in a first orientation; engaging an alignment feature with the radiopaque insert, the alignment feature extending / protruding from a surface of the cap into the recess to maintain the radiopaque insert in the first orientation and prevent the radiopaque insert from engaging the recess in a second orientation different from the first orientation; and mating a base with the cap, a portion of the base extending across the recess to secure the radiopaque insert within the recess in the first orientation.

[0011] In some embodiments, the base defines a reservoir and includes a stem extending along the longitudinal axis from the base, the stem in fluid communication with the reservoir. In some embodiments, the method further comprises securing a septum onto said reservoir when the base is coupled with said cap.

[0012] In some embodiments, one of the alignment feature or the base is configured to abut the radiopaque insert in the second orientation to prevent the cap from engaging the base.

[0013] In some embodiments, the alignment feature engages with a notch disposed on a periphery of the radiopaque insert, the alignment feature engaging with the notch in a first orientation and abutting a portion of the periphery of the radiopaque insert in a second orientation.

[0014] In some embodiments, the alignment feature is configured to engage the opening in a first orientation and abut a portion of the radiopaque insert in a second orientation.

[0015] In some embodiments, the symbol indicates a characteristic of the port. In some embodiments, the symbol includes the letters "CT." In some embodiments, the insert is disposed along the longitudinal axis on an opposite side of the reservoir from the stem.

[0016] In some embodiments, the reservoir is disposed along the longitudinal axis between the stem and the insert. In some embodiments, the nose extends from the port along the longitudinal axis opposite the stem.

[0017] In some embodiments, a method for manufacturing an access device according to any of the preceding items is disclosed. A more particular description of the present disclosure will be provided by reference to specific embodiments thereof, which are illustrated in the accompanying drawings, which depict only typical embodiments of the invention and therefore should not be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which: [Brief description of the drawings]

[0018] [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 illustrates an exploded bottom view of a port including an identification marker according to an embodiment disclosed herein. [Figure 4A] 1 illustrates a perspective bottom view of a base of a port according to an embodiment disclosed herein. [Figure 4B] 1 illustrates a perspective bottom view of a cap of a port including an identification marker according to an embodiment disclosed herein. [Figure 5A] 13 shows an enlarged detail view of a recess including an alignment feature according to an embodiment disclosed herein. [Figure 5B] 13 shows an enlarged detail view of a recess including an alignment feature that is engaged with an identification marker according to an embodiment disclosed herein. [Figure 6] 1 shows a cross-sectional view of a nose portion of a port including an identification marker according to an embodiment disclosed herein. [Figure 7A] 1 shows an exemplary identification marker according to embodiments disclosed herein. [Figure 7B] 1 shows an exemplary identification marker according to embodiments disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] 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.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] 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.

[0024] 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.

[0025] 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 will be disposed 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.

[0026] 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.

[0027] 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.

[0028] 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 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.

[0029] 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 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 within the base 110 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.

[0030] FIG. 2 illustrates an exploded view of the port 100 of FIG. 1B with the base 110 separated from the cap 120. In one embodiment, one or both of the base 110 and the cap 120 may include a recess 122 disposed within 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 depth (d). In one embodiment, the periphery 124 of the recess 122 may define a curved or polygonal shape extending in a horizontal plane. As illustrated, the periphery 124 may define a substantially crescent shape 124, or "arcuate". However, it should be understood that other curved or polygonal shapes are also contemplated.

[0031] In one embodiment, the port 100 may further include an identification marker, i.e., an identification insert ("insert") 150 configured to fit within the recess 122. The insert 122 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.

[0032] In one embodiment, the shape of the outer periphery 154 of the insert 150 may mirror the outer periphery 124 of the recess 122. For example, as shown in FIG. 2, the outer periphery of the insert 154 may define a crescent shape or “arc” that is the same as or slightly smaller than the crescent shape of the outer periphery 124 of the recess 122. However, other curvilinear or polygonal shapes are also contemplated. In one embodiment, the insert 150 may be secured within the recess 122 using one of an adhesive, bonding, welding, or the like. In one embodiment, the outer periphery 154 of the insert may define a shape that is the same as or slightly smaller than the shape of the outer periphery 124 of the recess 122. Thus, the insert 150 may engage the recess with a press fit, an interference fit, or a snap fit engagement.

[0033] In one embodiment, the insert 150 may include one or more openings 152 extending along a transverse axis through the insert 150. The periphery of the openings 152 may define a symbol, such as an alphanumeric symbol, shape, or icon, as described herein. Thus, the openings 152 may define a "punch-out" symbol 152 and may be referred to as a "negative" insert. In contrast, a "positive" insert may include a periphery that defines one or more symbols.

[0034] 2, 3, 4B, 5B, 7A and 7B, the opening 152 may define one or more characters, such as "CT." Thus, when the negative insert 150 is imaged using medical imaging techniques, the radiopaque portions of the insert 150 may contrast with the periphery of the opening 152 and the periphery 154 of the insert 150 to define a symbol. Thus, when the insert 150 is imaged subcutaneously, it may indicate one or more characteristics of the port 100, a location or orientation of the port 100.

[0035] In one embodiment, the port 100 may further include an alignment feature 160. The alignment feature 160 may be configured to engage a portion of the insert 150 and align the insert 150 with the recess 122 in a first orientation in three-dimensional space. Additionally, the alignment feature 160 may also be configured to prevent the insert 150 from engaging the recess 122 in a second orientation in three-dimensional space that is different from the first orientation.

[0036] In one embodiment, as shown in Figures 2, 4B, and 5A-6, the alignment feature 160 may include a protrusion extending transversely from one of the cap 120 or the base 110 into the recess 122 a distance equal to or less than the depth (d) of the recess 122. The alignment feature 160 may be disposed within the recess 122 to engage with the opening 152. For example, as shown in Figure 2, the alignment feature 160 may include a linear protrusion extending into the recess 122 and extending along the longitudinal axis. The alignment feature 160 may be configured to engage with a "T" shaped opening 152. However, the alignment feature 160 may extend linearly or curvilinearly, longitudinally, laterally, and / or at an angle in between, and may engage one or more portions of the opening 152. For example, the alignment features may engage one or more of the intersections of the “T” shaped openings 152 or the curved portions of the “C” shaped openings 152 .

[0037] In one embodiment, the port 100 may include two or more alignment features 160 configured to engage with one or more openings 152. For example, the one or more alignment features 160 may include one or more posts that extend transversely into the recess 122 and define a circular or polygonal horizontal cross-sectional shape. The one or more alignment features 160 may be disposed within the recess 122 to engage with the first opening 152. These and other numbers and combinations of alignment features 160 are contemplated as falling within the scope of the present invention.

[0038] In one embodiment, a portion of the base 110 may extend over at least a portion of the recess 122 and secure the insert 122 within the recess in a first orientation. As shown in FIG. 2, a portion of the base 110 may extend across the entire recess 122 to seal the insert 150 within the recess 122. The base 110 may be attached to the cap 120 using adhesives, bonding, welding, or a similar suitable method. When the insert 150 is placed within the recess 122 in a second orientation different from the first orientation, the alignment feature 160 may be misaligned with respect to the opening 152 and may abut a portion of the insert 150. Thus, the insert 150 is not fully received within the recess 122 and the base 110 cannot fully engage with the cap 120. Advantageously, the alignment feature 160 may be configured to prevent the insert 150 from being placed incorrectly within the recess 122 and to prevent the port 100 from being assembled incorrectly.

[0039] In one embodiment, the symbol 104 disposed on the underside of the base 110 may be aligned with a negative symbol defined by the opening 152 of the insert 150. Thus, the symbol 104 may provide a visual representation of the symbol defined by the insert 150 disposed within the recess 122. In one embodiment, one or both of the base 110 and the cap 120 may be formed from an opaque material. Thus, the insert 150 may not be directly observable when installed within the port 100.

[0040] In one embodiment, as shown in FIGS. 4A and 4B, the symbol 104 may include an alphanumeric symbol engraved in reverse on the bottom surface of the base 110 to align with the symbol defined by the opening 152 in the recess 122. Thus, the symbol 104 may visually communicate the orientation of the insert 150 in the recess 122. During subcutaneous placement of the port 100, a user may view the symbol 104 to verify that the insert 150 is correctly positioned. In one embodiment, the base 110 may include a first symbol 104A configured to align with the insert 150 positioned in the recess 122. As described herein, the base 110 may further include a second symbol 104B 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.

[0041] In one embodiment, one or both of the base 110 and the cap 120 may be formed from a transparent or translucent material so that a user may directly observe the insert 150 disposed within the recess 122 when the port 100 is assembled. In one embodiment, one or both of the base 110 and the cap 120 may include a window so that a user may directly observe the insert 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, the base 110 and the cap 120 may cooperate to provide a smooth profile and may house the insert 150 therein to prevent any tissue from ingrowing into the opening 152 when the port 100 is placed subcutaneously.

[0042] 3, the alignment feature 160 may extend horizontally from the periphery 124 of the recess 122 into the recess 122. The alignment feature 160 may be disposed along the periphery 124 of the recess 122 to engage with a notch 156 disposed on the periphery 154 of the insert 150. Thus, as described herein, the alignment feature 160 may allow the insert 150 to align with the recess 122 in a first orientation, but may prevent the insert 150 from engaging with the recess 122 in a second orientation that is different from the first orientation.

[0043] 7A and 7B show further details of an example insert 150 , including one or more openings 152 and notches 156 . 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; a longitudinally extending stem in fluid communication with the reservoir; a septum disposed on the reservoir; a cap configured to engage the base and secure the septum on the reservoir, the cap including a nose defining a recess; an alignment feature including a protrusion extending from a surface of the recess into the recess; 1. A subcutaneous access port comprising: a radiopaque insert including an opening, a periphery of the opening defining a symbol, the radiopaque insert configured to fit within the recess in a first orientation, and the protrusion configured to maintain the radiopaque insert in the first orientation and prevent the radiopaque insert from engaging the recess in a second orientation different from the first orientation.

2. The subcutaneous access port of claim 1 , wherein the base engages the cap to secure the radiopaque insert within the recess in the first orientation.

3. The subcutaneous access port of claim 1 or 2, wherein one of the projection or the base abuts the radiopaque insert in the second orientation to prevent the cap from engaging the base.

4. The subcutaneous access port of any one of claims 1 to 3, wherein the protrusion is configured to engage with a notch disposed on a periphery of the radiopaque insert in the first orientation and to abut a portion of the periphery of the radiopaque insert in the second orientation.

5. The subcutaneous access port of any one of claims 1 to 3, wherein the protrusion is configured to engage with the opening in the first orientation and abut a portion of the radiopaque insert in the second orientation.

6. The subcutaneous access port of any one of claims 1 to 5, wherein the symbol indicates a characteristic of the port.

7. The subcutaneous access port of any one of claims 1 to 6, wherein the symbol includes the letters "CT."

8. The subcutaneous access port of any one of claims 1 to 7, wherein the insert is positioned along a longitudinal axis on an opposite side of the reservoir from the stem.

9. The subcutaneous access port of any one of claims 1 to 8, wherein the reservoir is disposed between the stem and the insert along a longitudinal axis.

10. The subcutaneous access port of any one of claims 1 to 9, wherein the nose extends from the port along a longitudinal axis opposite the stem.

11. providing a cap including a nose portion defining a recess; placing a radiopaque insert including an aperture, a periphery of the aperture defining a symbol, within the recess in a first orientation; engaging an alignment feature with the radiopaque insert, the alignment feature extending from a surface of the cap into the recess to maintain the radiopaque insert in the first orientation and prevent the radiopaque insert from engaging the recess in a second orientation different from the first orientation; coupling a base to the cap, a portion of the base extending across the recess to secure the radiopaque insert within the recess in the first orientation; A method for manufacturing a subcutaneous access port comprising:

12. The method of claim 11 , wherein the base defines a reservoir and includes a stem extending along a longitudinal axis from the base, the stem being in fluid communication with the reservoir.

13. The method of claim 12 , further comprising securing a septum onto the reservoir when the base is coupled with the cap.

14. The method of any one of claims 11 to 13, wherein one of the alignment feature or the base abuts the radiopaque insert in the second orientation to prevent the cap from engaging the base.

15. 15. The method of any one of claims 11 to 14, wherein the alignment feature engages with a notch disposed on a periphery of the radiopaque insert, the alignment feature engaging with the notch in the first orientation and abutting a portion of the periphery of the radiopaque insert in the second orientation.

16. The method of any one of claims 11 to 14, wherein the alignment feature is configured to engage the opening in the first orientation and abut a portion of the radiopaque insert in the second orientation.

17. The method of any one of claims 11 to 16, wherein the symbols indicate characteristics of the ports.

18. The method of any one of claims 11 to 17, wherein the symbol comprises the letters "CT".

19. The method of any one of claims 11 to 18, wherein the insert is positioned along a longitudinal axis on an opposite side of the reservoir from the stem.

20. The method of any one of claims 11 to 19, wherein the reservoir is disposed between the stem and the insert along a longitudinal axis.

21. The method of any one of claims 11 to 20, wherein the nose portion extends from the port along a longitudinal axis opposite the stem.

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