Tactile recessed port septum

Abstract

The embodiments disclosed herein are directed to a subcutaneous vascular access port that includes a septum having a concave portion on an upper surface and an annular tactile rim. The septum may define a radially symmetric shape extending around a central transverse axis. The top edge of the tactile rim may define the top edge of the port. The rim may include an outer surface extending outwardly from the top edge and an inner surface extending radially inwardly from the top edge of the rim. The concave surface of the septum and / or the rim can provide a tactile feature for indicating the location of the port, or more specifically, the location of a reservoir disposed therebelow. The concave septum provides a tactile feature while reducing the overall height of the port. This can be important for a low-profile port designed to reduce stretching of the skin surface that can lead to skin breakdown.

Description

Technical Field

[0001] Briefly summarized, embodiments of the present invention are directed to a subcutaneous vascular access device, or “port,” that includes a septum having a concave upper surface and an annular tactile rim.

Summary of the Invention

[0002] The septum may define a radially symmetric shape extending around a central transverse axis. The top edge of the tactile rim may define the top edge of the port. The rim may include an outer surface extending from the top edge of the rim to the radially outermost edge of the septum and an inner surface extending from the top edge of the rim to the central transverse axis.

[0003] Advantageously, the concave surface of the septum can provide a tactile feature for indicating the location of the port, or more specifically, the location of a reservoir disposed below the septum in the transverse direction, for percutaneous access using a needle. Further, the concave septum provides a tactile feature without unnecessarily increasing the overall transverse height of the port. This can be important for low-profile ports designed to reduce stretching of the skin surface that can lead to skin breakdown.

[0004] Disclosed herein is a vascular access port including a port body having a reservoir and a septum disposed on top of the reservoir and held by the port body, the septum including a concave upper surface configured to be penetrated by a needle to enable fluid communication between the needle and the reservoir, and a continuous rim extending around a central transverse axis of the concave surface.

[0005] In some embodiments, the septum defines a radially symmetric shape extending around a central transverse axis. In some embodiments, the continuous rim extends laterally outward from the topmost surface of the port body, away from the access port.

[0006] In some embodiments, the upper surface of the continuous rim defines the topmost surface of the vascular access port. In some embodiments, the septum including the continuous rim is formed of a flexible material selected from the group consisting of plastic, polymer, elastomer, organic rubber, synthetic rubber, or silicone rubber.

[0007] In some embodiments, the continuous rim includes an outer surface extending between the uppermost edge and the radially outermost edge, and an inner surface extending between the uppermost edge and the central transverse axis. In some embodiments, the outer surface defines a concave cross-sectional shape.

[0008] In some embodiments, the outer surface defines a convex cross-sectional shape. In some embodiments, the outer surface defines a continuous inclination with respect to the central transverse axis. In some embodiments, the inner surface defines a convex cross-sectional shape.

[0009] In some embodiments, the inner surface includes an S-shaped cross-sectional shape including a convex portion and a concave portion. In some embodiments, the inner surface includes one of a discontinuous change in inclination or a continuous change in inclination.

[0010] In some embodiments, one or both of the outer surface and the inner surface include a vertical portion extending parallel to the central transverse axis. In some embodiments, the concave surface includes a portion extending below the uppermost surface of the port body.

[0011] In some embodiments, the septum includes a flange extending radially outward from the side surface of the septum. In some embodiments, the port is configured to be disposed subcutaneously and further includes a catheter coupled to the port stem and in fluid communication with the reservoir, and a distal tip of the catheter is disposed within the vascular system.

[0012] Also disclosed is a method of manufacturing a vascular access port, the method including forming a port body that defines a reservoir and coupling a septum to the port body. The septum is disposed over the reservoir and has an upper surface that is configured to be penetrated by a needle to allow fluid communication between the needle and the reservoir, the upper surface having a concave portion, and a continuous rim extending around a central transverse axis of the concave surface.

[0013] In some embodiments, the septum defines a radially symmetric shape that extends around a central transverse axis. In some embodiments, the continuous rim extends laterally outward from the uppermost surface of the port body and extends away from the port body.

[0014] In some embodiments, the upper surface of the continuous rim defines the uppermost surface of the vascular access port. In some embodiments, the septum including the continuous rim is formed of a flexible material selected from the group consisting of plastic, polymer, elastomer, organic rubber, or synthetic rubber, or silicone rubber.

[0015] In some embodiments, the continuous rim includes an outer surface that extends between a top edge and a radially outermost edge, and an inner surface that extends between the top edge and the central transverse axis. In some embodiments, the outer surface defines a concave cross-sectional shape.

[0016] In some embodiments, the outer surface defines a convex cross-sectional shape. In some embodiments, the outer surface defines a continuous slope. In some embodiments, the inner surface defines a convex cross-sectional shape.

[0017] In some embodiments, the inner surface includes an S-shaped cross-sectional shape including a convex portion and a concave portion. In some embodiments, the inner surface includes one of a discontinuous change in slope or a continuous change in slope.

[0018] In some embodiments, one or both of the outer surface and the inner surface include a vertical cross-section that extends parallel to the central transverse axis. In some embodiments, the concave surface includes a portion that extends below the uppermost surface of the port body.

[0019] In some embodiments, the septum includes a flange that extends radially outward from the side surface of the septum. Also disclosed is a method of accessing a vascular access port, comprising palpating the septum of the vascular access port to determine the rim of the septum and the concave central point of the septum, wherein the rim defines the uppermost edge of the vascular access port, inserting an access needle into the central point of the septum, penetrating the septum, and accessing the reservoir of the vascular access port to provide fluid communication with the needle.

[0020] In some embodiments, the rim extends continuously around the transverse central point of the septum. In some embodiments, the diameter of the uppermost edge of the septum is less than or equal to the transverse diameter of the reservoir. In some embodiments, the concave central point of the septum extends transversely downward from the uppermost edge of the body of the vascular access port.

[0021] A more detailed description of the present disclosure is given by reference to the specific embodiments shown in the accompanying drawings. It should be understood that these drawings show only typical embodiments of the invention and should not be considered as limiting the scope of the invention. The exemplary embodiments of the invention are described and explained in more specific and detailed manner by using the accompanying drawings.

Brief Description of the Drawings

[0022]

Figure 1A

Figure 1B

Figure 2A

Figure 2B

Figure 3A

Figure 3B

Figure 4A

Figure 4B

Figure 5

Figure 6

Figure 7

Figure 8

DETAILED DESCRIPTION OF THE INVENTION

[0023] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. Also, it should be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments and optionally combined with or substituted for the features of any of several other embodiments disclosed herein. The drawings are schematic and diagrammatic representations of exemplary embodiments of the present invention and are not limiting and are not necessarily drawn to scale.

[0024] Regarding the terms used in this specification, it should also be understood that these terms are for the purpose of describing some specific embodiments and are not intended to limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide a sequential or numerical limitation. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps does not necessarily have to be limited to three features or steps. Expressions such as "left", "right", "up", "down", "front", "rear", etc. are used for convenience and do not, for example, mean any particular fixed position, orientation, or direction. Rather, such expressions are used, for example, to indicate relative position, orientation, or direction. Unless clearly indicated otherwise from the context, the singular forms represented by "a", "an", and "the" include the plural forms. Also, the words "including", "has", and "having" used in this specification, including the claims, shall have the same meaning as the word "comprising".

[0025] In the following description, the terms "or" and "and / or" used in this specification should be construed to include or mean any one or any combination. For example, "A, B, or C" or "A, B, and / or C" means "any one of A, B, C, A and B, A and C, B and C, A and B and C". This definition is only an exception when the elements, components, functions, steps, or operations are mutually exclusive in some way.

[0026] Regarding "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter as disclosed herein includes a portion of the catheter that is 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 that is 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 that is 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 may include the proximal end of the catheter, but 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 distal portion or distal length of the catheter.

[0027] Regarding "distal," for example, the "distal portion" or "distal end portion" of a catheter as disclosed herein includes a portion of the catheter that is intended to be near or within the patient when the catheter is used on a patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be near or within the patient when the catheter is used on a patient. For example, the "distal end" of a catheter includes the end of the catheter that is intended to be near or within the patient when the catheter is used on a patient. The distal portion, distal end portion, or distal length of a catheter may include the distal end of the catheter. However, the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a catheter is not the distal portion or distal length of the catheter.

[0028] To assist in the description of the embodiments disclosed herein, as shown in FIG. 1A, the longitudinal axis extends generally parallel to the axial length of the port stem. The transverse axis extends perpendicular to the longitudinal axis, and the cross-sectional axis extends perpendicular to both the longitudinal axis and the transverse axis. The vertical axis may extend parallel to the cross-sectional axis. The horizontal axis may extend perpendicular to the vertical axis. The horizontal plane may be defined by the longitudinal axis and the transverse axis. The vertical plane may extend perpendicular to the horizontal plane.

[0029] As used herein, a "top" or "upper" surface or direction is a surface or direction that extends along a transverse axis that is relatively close to the skin surface when the port 100 is placed subcutaneously, i.e., a surface or direction that is relatively far from the base 106 of the port 100. Similarly, a "bottom" or "lower" surface or direction is a surface or direction that extends along a transverse axis that is relatively far from the skin surface when the port 100 is placed subcutaneously, i.e., a surface or direction that is relatively close to the base 106 of the port 100.

[0030] 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. FIGS. 1A - 1B show an embodiment of a subcutaneous vascular access device, i.e., a "port" 100. The port 100 generally includes a port body 102 that defines a reservoir 104 and includes a port stem 110. The port stem 110 may extend along the longitudinal axis from the port body 102 and may define a stem lumen 112 that is in fluid communication with the reservoir 104.

[0031] In one embodiment, the body 102 may include a base portion (the "base") 106 and a housing 108. The housing 108 may be formed from the same material as the base 106 or a different material. In one embodiment, the housing 108 may be overmolded onto the base 106. In one embodiment, the housing 108 may engage the base 106 by one or more of press fitting, interference fitting, or snap fit engagement. In one embodiment, the housing 108 may be secured to the base 106 using an adhesive, bonding, welding, ultrasonic welding, or the like. In one embodiment, one of the base 106 or the housing 108 may define a reservoir 104. In one embodiment, the base 106 and the housing 108 may cooperate to define a reservoir 104.

[0032] In one embodiment, the body 102 may define a transverse height (h1) that extends between the lowermost and uppermost surfaces of the body 102. As described above, the port 100 may be designed to maintain an outer profile with a transverse height (h1) that is as low as possible to relieve skin stretch and reduce skin abrasion when placed subcutaneously.

[0033] In one embodiment, the port 100 may be disposed over the reservoir 104 and may further include a needle-penetrable septum 120 configured to provide percutaneous access to the reservoir 104 by an access needle (not shown). When the port 100 is placed subcutaneously, the access needle may penetrate the skin surface and extend transversely therethrough and penetrate the septum 120 to provide fluid communication with the reservoir 104. Fluid may then pass through the access needle, enter the reservoir 104, pass through the port stem lumen 112, and enter the lumen of a catheter coupled to the port stem 110. The distal tip of the catheter may be disposed within the patient's vasculature.

[0034] In one embodiment, the septum 120 may define a radially symmetric shape that extends around the central transverse axis 90. As shown in FIG. 1B, the cross-sectional shape of the upper surface of the septum 120 may extend between the central transverse axis 90 and the radially outermost edge 94. In one embodiment, at least a portion of the upper surface of the septum 120, for example, the central portion, may define a concave shape. Accordingly, the uppermost edge portion, or the apex edge portion 92 of the septum 120, may be disposed radially outward from the central transverse axis 90 so as to define the tactile ring 124. In one embodiment, the entire upper surface of the septum 120 may define a concave surface. As used herein, the apex edge portion is the edge or surface that is disposed furthest laterally from the base 106 of the port 100.

[0035] In one embodiment, a portion of the upper surface of the septum 120 disposed on the central transverse axis 90 can be aligned laterally with the apex edge portion of the port body 102. Accordingly, the tactile ring 124 may extend by a second height (h2) from the uppermost surface of the port body 102. In one embodiment, the septum 120 may be formed of a relatively flexible material such as plastic, polymer, elastomer, organic or synthetic rubber, silicone rubber, etc.

[0036] It should be noted that when the port 100 is disposed subcutaneously, the skin surface tissue is stretched and inflated over the port 100 so as to conform to the lateral height of the port 100. Skin erosion can occur when the skin surface tissue contacts the uppermost edge portion of the port 100 and is stretched thereon. To reduce stretching and skin erosion, low-profile ports, i.e., ports with reduced lateral height, have been developed. As described herein, the apex edge portion of the port 100 may be defined by the apex edge 92 of the tactile ring 124 formed of a relatively flexible material of the septum 120. Accordingly, the flexible tactile ring 124 can be elastically deformed to reduce skin erosion by dispersing pressure across the skin surface tissue.

[0037] In one embodiment, the septum 120 may include a flange 122 that extends from a side surface of the septum 120 and extends annularly around the central transverse axis 90. The flange 122 can be fixed in place on the reservoir 104 by engaging a channel 114 defined by the port body 102. In one embodiment, the base 106 and the housing 108 can cooperate to define the channel 114.

[0038] In one embodiment, the cross-sectional shape of the haptic ring 124 may define an inner surface 128 and an outer surface 126. The inner surface 128 of the haptic ring 124 may extend from the central transverse axis 90 to the top edge 92. The outer surface 126 of the haptic ring 124 may extend from the top edge 92 to the outermost edge 94. As described above, the septum 120 defines a radially symmetric shape about the central transverse axis 90.

[0039] As shown in FIG. 1B, in one embodiment, the inner surface 128 of the haptic ring 124 may define a concave cross-sectional shape. In one embodiment, the outer surface 126 of the haptic ring 124 may define a convex cross-sectional shape. Advantageously, the convex shape of the outer surface 126 of the haptic ring 124 can further disperse pressure across the skin surface tissue stretched over the port 100 and can reduce skin abrasion when the port is placed subcutaneously.

[0040] When the port 100 is placed subcutaneously, the haptic ring 124 of the septum 120 may extend away from the port body 102 and extend laterally outward from the port 100 and may be touched by the user to determine the position of the port 100. More specifically, the haptic ring 124 may provide a concave central portion on the upper surface of the septum 120. Advantageously, the concave upper surface of the septum 120 can align the finger or access needle with the reservoir 104 disposed below in the transverse direction of the septum 120 by directing the user's finger and / or access needle toward the central transverse axis 90.

[0041] In one embodiment, the top edge 92 of the tactile ring 124 may be aligned transversely with or just inside the vertical wall of the reservoir 104. Thus, the tactile ring 124 can indicate the horizontal installation surface of the underlying reservoir 104. Advantageously, the concave surface of the septum 120 defined by the top edge 92 of the tactile ring 124 can indicate the position of the reservoir 104 to the user, so that the user can select a position within the tactile ring 124 to access the reservoir 104 using an access needle.

[0042] By passing an access needle through the septum 120 within the top edge 92 of the septum 120, the access needle can reliably access the reservoir 104. In other words, the horizontal surface area of the inner surface 128 of the septum 120 may be equal to or slightly smaller than the horizontal surface area of the reservoir 104. Thus, by piercing the septum at any point within the inner surface 128 defined by the top edge 92, the user can reliably access the reservoir 104. In one embodiment, the radially outermost edge 94 of the tactile ring 124 may extend beyond the radially outermost edge of the reservoir 104. In other words, the horizontal surface area defined by the tactile ring 124 may be equal to or slightly larger than the horizontal surface area of the reservoir 104. In one embodiment, the outer surface 126 of the tactile ring 124 can define a smooth transition surface between the outer surface of the port body 102 and the tactile ring 124, thereby reducing stretching or skin abrasion.

[0043] In one embodiment, as shown in FIG. 1B, the cross-sectional shape of the inner surface 128 of the tactile ring 124 may define a relatively steep slope proximate to the uppermost edge 92 before tapering to a relatively shallow slope toward the central transverse axis 90. Thus, the inner surface 128 of the tactile ring 124 can define a relatively wide bowl shape, providing a relatively large horizontal surface area through which the user can access the reservoir 104 through the septum 120. Advantageously, the relatively wide inner surface 128 of the tactile ring 124 allows the user to access the reservoir at different positions, reducing the formation of scar tissue due to repeated access or degradation of the skin surface tissue disposed thereon. As used herein, the "slope" of a surface is defined with respect to a horizontal plane.

[0044] FIGS. 2A-2B illustrate an embodiment of a port 100 that includes a septum 120 having a concave upper surface and a tactile ring 224. The tactile ring 224 may define an outer surface 226 that extends between the uppermost edge 92 and the radially outermost edge 94, and an inner surface 228 that extends between the uppermost edge 92 and the central transverse axis 90, as described herein.

[0045] In one embodiment, the cross-sectional shape of the inner surface 228 of the tactile ring 220 may define a relatively more consistent slope that extends between the apex edge 92 and the central transverse axis 90. Advantageously, the relatively consistent slope of the inner surface 228 can facilitate accuracy when accessing the reservoir 104 by directing the user toward the central transverse axis 90. This can be particularly important when accessing a reduced-size port system, such as a port system disposed on a limb, such as an arm.

[0046] In one embodiment, the outer surface 226 of the haptic ring 224 that extends radially outward from the uppermost edge portion 92 to the radially outermost edge portion 94 of the haptic ring 224 may define a concave cross-sectional shape. In one embodiment, the portion of the outer surface 226 disposed adjacent to the uppermost edge portion 92 may define a relatively steep slope before tapering to a relatively shallow slope adjacent to the radially outermost edge portion 94. In one embodiment, the portion of the outer surface 226 disposed adjacent to the uppermost edge portion 92 may define a substantially vertical slope before tapering to a relatively shallow slope adjacent to the radially outermost edge portion 94. Advantageously, the concave outer surface 226 of the haptic ring 224 can reduce the contact surface area between the haptic ring outer surface 226 and the skin surface tissue extending over the port 100, thereby reducing skin abrasion by reducing the contact therebetween. Advantageously, the concave outer surface 226 of the haptic ring 224 including the steep slope or vertical portion can provide a haptic feature that can improve the distinctiveness of the haptic ring 224 and is more easily distinguishable when disposed subcutaneously.

[0047] Figures 3A-3B illustrate an embodiment of port 100 including a septum 120 having a concave upper surface and a haptic ring 324. The haptic ring 324 may define an outer surface 326 that extends between an uppermost edge portion 92 and a radially outermost edge portion 94, as well as an inner surface 328 that extends between the uppermost edge portion 92 and a central transverse axis 90, as described herein. In one embodiment, the outer surface 326 of the haptic ring 324 may define a concave cross-sectional shape. In one embodiment, the portion of the outer surface 326 disposed adjacent to the uppermost edge portion 92 may define a relatively steep or vertical slope before tapering to a relatively shallow slope adjacent to the radially outermost edge portion 94.

[0048] In one embodiment, the inner surface 328 of the haptic ring 324 may also define a relatively steep or vertical portion adjacent to the top edge 92 before tapering to a relatively shallow slope adjacent to the central transverse axis 90. Advantageously, the vertical portions of the inner surface 328 and the outer surface 326 disposed on both sides of the top edge 92 may define a distinct haptic ring 324 to facilitate the palpation of the port 100 when disposed subcutaneously. Further, the concave inner surface 328 and the concave outer surface 326 can reduce skin abrasion by reducing the contact surface area between the port 100 and the skin tissue disposed thereon.

[0049] Figures 4A-4B illustrate an embodiment of the port 100 including a septum 120 having a concave upper surface and a haptic ring 424. The haptic ring 424 may define an outer surface 426 extending between the top edge 92 and the radially outermost edge 94, as well as an inner surface 428 extending between the top edge 92 and the central transverse axis 90, as described herein.

[0050] In one embodiment, the outer surface 426 of the haptic ring 124 may extend in a substantially continuous slope between the top edge 92 and the radially outermost edge 94 to define a frustoconical shape with respect to the haptic ring 424. Advantageously, the outer surface 426 provides a smooth transition between the port body 102 and the top edge 92 of the haptic ring 424, reducing pressure points on the skin surface tissue stretched thereon and reducing skin abrasion.

[0051] In one embodiment, the inner surface 428 of the haptic ring 424 may define a concave cross-sectional shape and may include a vertical portion disposed adjacent to the top edge 92. The inner surface 428 may then provide a continuous change in slope between the vertical portion and the central transverse axis 90 to provide a rounded concave portion on the inner surface 416 of the haptic ring 424. Advantageously, the inner surface 428 can both direct the user towards the central transverse axis 90 and provide a relatively large horizontal surface area for accessing the reservoir 104 at various positions, reducing the accumulation of scar tissue from repeated punctures at the same location.

[0052] Figures 5-8 show cross-sectional views of embodiments of the diaphragm 120 for use with the low-profile port 100 and include a concave portion on the upper surface and a haptic ring. Generally, the diaphragm 120 may define a radially symmetric shape and may include a concave portion on the upper surface that extends between the top edge 92 and the central transverse axis 90. Thus, the top edge 92 may define a haptic ring that continuously extends around the central transverse axis 90, as described herein. In one embodiment, as described herein, the haptic ring may include an inner surface that extends between the top edge 92 and the central transverse axis 90 and an outer surface that extends between the top edge 92 and the radially outermost edge 94. In one embodiment, the top edge 92 of the haptic ring may extend laterally outward in the transverse direction from the top edge of the port body 102 to define the top edge of the port 100 as a whole.

[0053] In one embodiment, a portion of the inner surface may extend below the top edge of the port body 102 in the transverse direction. Thus, the upper surface of the diaphragm 120 may define a concave surface that extends over a transverse height (h2) while reducing the overall transverse height of the port 100, i.e., the height of the port 100 ≤ height (h1) + height (h2). Advantageously, the overall transverse height of the port 100 can be reduced without reducing the effectiveness (depth) of the haptic ring and the concave portion in touch.

[0054] Figure 5 shows an embodiment of the diaphragm 120 that includes a concave portion and a haptic ring 524. The outer surface 526 of the haptic ring 524 may define a convex cross-sectional shape. The inner surface 528 of the haptic ring 524 may define an S-shaped curved cross-sectional shape that curves in a first direction adjacent to the top edge 92 before transitioning through an inflection point and curves in a second direction opposite to the first direction adjacent to the central transverse axis 90.

[0055] FIG. 6 shows an embodiment of the diaphragm 120 that includes a concave portion and a haptic ring 624. The outer surface 626 of the haptic ring 624 may define a consistent slope between the top edge 92 and the outermost edge 94. The inner surface 628 of the haptic ring 624 may define a consistent change in slope between a relatively steep or vertical slope adjacent to the top edge 92 and a relatively shallow slope adjacent to the central transverse axis 90.

[0056] FIG. 7 shows an embodiment of the diaphragm 120 that includes a concave portion and a haptic ring 724. The outer surface 726 of the haptic ring 724 may include a substantially vertical portion adjacent to the top edge 92 and a convex portion adjacent to the outermost edge 94. The inner surface 728 of the haptic ring 724 may include a consistent change in slope between a relatively steep slope adjacent to the uppermost edge 92 and a relatively shallow slope adjacent to the central transverse axis 90.

[0057] FIG. 8 shows an embodiment of the diaphragm 120 that includes a concave portion and a haptic ring 824. The outer surface 826 of the haptic ring 824 may include a consistent slope between the top edge 92 and the outermost edge 94. The inner surface 828 of the haptic ring 824 may include a portion that includes a consistent change in slope between a substantially vertical portion adjacent to the top edge 92 and a relatively steep slope adjacent to the top edge 92 and a relatively shallow slope adjacent to the central transverse axis 90.

[0058] Some specific embodiments are disclosed herein, and while the specific embodiments are disclosed to a certain degree of detail, it is not intended that the specific embodiments limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and in a broader sense, these adaptations and / or modifications are also included. Accordingly, it is possible to depart from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A vascular access port, comprising: a port body having a reservoir; a septum disposed on the reservoir and held by the port body, the septum having: a concave upper surface configured to be penetrated by a needle to enable fluid communication between the needle and the reservoir; and a continuous rim extending around a central transverse axis of the concave surface.

2. The vascular access port according to claim 1, wherein the septum defines a radially symmetric shape extending around the central transverse axis.

3. The vascular access port according to claim 1 or 2, wherein the continuous rim extends laterally outward from the uppermost surface of the port body.

4. The vascular access port according to any one of claims 1 to 3, wherein an upper surface of the continuous rim defines the uppermost surface of the vascular access port.

5. The vascular access port according to any one of claims 1 to 4, wherein the septum including the continuous rim is formed of a flexible material selected from the group consisting of plastic, polymer, elastomer, organic rubber, synthetic rubber, or silicone rubber.

6. The vascular access port according to any one of claims 1 to 5, wherein the continuous rim includes an outer surface extending between a top edge and a radially outermost edge, and an inner surface extending between the top edge and the central transverse axis.

7. The vascular access port according to claim 6, wherein the outer surface defines a concave cross-sectional shape.

8. The vascular access port according to claim 6, wherein the outer surface defines a convex cross-sectional shape.

9. The vascular access port according to claim 6, wherein the outer surface defines a continuous slope with respect to the central transverse axis.

10. The vascular access port according to any one of claims 6 to 9, wherein the inner surface defines a convex cross-sectional shape.

11. The vascular access port according to any one of claims 6 to 9, wherein the inner surface includes an S-shaped cross-sectional shape including a convex portion and a concave portion.

12. The vascular access port according to any one of claims 6 to 11, wherein the inner surface includes one of a discontinuous change in slope or a continuous change in slope.

13. The vascular access port according to any one of claims 6 to 12, wherein one or both of the outer surface and the inner surface include a vertical portion extending parallel to the central transverse axis.

14. The vascular access port according to any one of claims 1 to 13, wherein the concave surface includes a portion extending below the uppermost surface of the port body.

15. The vascular access port according to any one of claims 1 to 14, wherein the septum includes a flange extending radially outward from a side surface of the septum.

16. The port is configured to be disposed subcutaneously and further includes a catheter coupled to the port stem and in fluid communication with the reservoir, wherein a distal tip of the catheter is disposed within the vascular system. The vascular access port according to any one of claims 1 to 15.

17. A method of manufacturing a vascular access port, comprising: forming a port body defining a reservoir; connecting a septum disposed on the reservoir to the port body, wherein the septum has an upper surface configured to be penetrated by the needle to enable fluid communication between the needle and the reservoir, and a continuous rim extending around a central transverse axis of the concave surface.

18. The method according to claim 17, wherein the septum defines a radially symmetric shape extending around the central transverse axis.

19. The method according to claim 17 or 18, wherein the continuous rim extends laterally outward from the uppermost surface of the port body.

20. The method according to any one of claims 17 to 19, wherein an upper surface of the continuous rim defines the uppermost surface of the vascular access port.

21. The method according to any one of claims 17 to 20, wherein the septum including the continuous rim is formed of a flexible material selected from the group consisting of plastic, polymer, elastomer, organic rubber, synthetic rubber, or silicone rubber.

22. The method according to any one of claims 17 to 21, wherein the continuous rim includes an outer surface extending between a top edge and a radially outermost edge, and an inner surface extending between the top edge and the central transverse axis.

23. The method according to claim 22, wherein the outer surface defines a concave cross-sectional shape.

24. The method according to claim 22, wherein the outer surface defines a convex cross-sectional shape.

25. The method according to claim 22, wherein the outer surface defines a continuous slope.

26. The method according to any one of claims 22 to 25, wherein the inner surface defines a convex cross-sectional shape.

27. The method according to any one of claims 22 to 25, wherein the inner surface has an S-shaped cross-sectional shape including a convex portion and a concave portion.

28. The method according to any one of claims 22 to 27, wherein the inner surface includes one of a discontinuous change in inclination or a continuous change in inclination.

29. The method according to any one of claims 22 to 28, wherein one or both of the outer surface and the inner surface include a vertical cross-section extending parallel to the central transverse axis.

30. The method according to any one of claims 17 to 29, wherein the concave surface includes a portion extending below the uppermost surface of the port body.

31. The method according to any one of claims 17 to 30, wherein the diaphragm includes a flange extending radially outward from a side surface of the diaphragm.

32. A method of accessing a vascular access port, comprising: palpating a diaphragm of the vascular access port to determine a rim of the diaphragm and a concave center point of the diaphragm, wherein the rim defines an uppermost edge of the vascular access port; inserting an access needle into the center point of the diaphragm; penetrating the diaphragm; accessing a reservoir of the vascular access port to provide fluid communication with the needle.

33. The method according to claim 32, wherein the rim extends continuously around a transverse center point of the diaphragm.

34. The method according to claim 32 or 33, wherein a diameter of the uppermost edge of the diaphragm is equal to or less than a transverse diameter of the reservoir.

35. The method according to any one of claims 32 to 34, wherein the concave center point of the diaphragm extends transversely downward from an uppermost edge of a body of the vascular access port.

Images