Palpation concave port baffle
The problem of skin erosion caused by existing port designs is solved by using concave top surfaces and annular palpation edges in the subcutaneous vascular access ports, achieving a reduction in skin stretching and erosion while providing palpation-friendly features.
Patent Information
- Application Number
- CN202280098132.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2022-07-20
- Publication Date
- 2025-03-07
AI Technical Summary
The existing subcutaneous vascular access port design is likely to cause skin erosion when placed subcutaneously, mainly due to its large lateral height, which leads to stretching and expanding the skin surface tissue.
A spacer with a concave top surface and an annular palpation edge defines a radial symmetric shape extending around the central transverse axis, the topmost edge of the palpation edge defines the topmost edge of the port, and provides palpation features through a spacer formed by a compliant material.
Reduces the overall lateral height of the port, reduces the stretching and expansion of skin surface tissue, thereby mitigating the risk of skin erosion, while providing palpation features for users to determine the port location.
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Figure CN119585011A_ABST
Abstract
Description
Summary of the invention
[0001] Briefly summarized, embodiments of the present invention are directed to a subcutaneous vascular access device or "port" that includes a barrier having a concave top surface and an annular palpation edge. The barrier can define a radially symmetrical shape extending about a central transverse axis. The topmost edge of the palpation edge can define the topmost edge of the port. The edge can include an outer surface extending from the topmost edge of the edge to the radially outermost edge of the barrier, and an inner surface extending from the topmost edge of the edge to the central transverse axis.
[0002] Advantageously, the concave surface of the barrier can provide a palpation feature to indicate the location of the port, or more specifically, the location of a reservoir disposed laterally below the barrier, for percutaneous access with a needle. Furthermore, the concave barrier provides the palpation feature without unnecessarily increasing the overall lateral height of the port. This can be very important for low-profile ports designed to reduce stretching of the skin surface that can lead to skin erosions.
[0003] Disclosed herein is a vascular access port comprising: a port body having a reservoir; and a barrier positioned above the reservoir and captured by the port body, the barrier comprising: a concave top surface configured to be penetrated by a needle to allow fluid communication between the needle and the reservoir; and a continuous rim extending around a central lateral axis of the concave surface.
[0004] In some embodiments, the barrier defines a radially symmetrical shape extending about a central transverse axis.
[0005] In some embodiments, the continuous rim extends laterally outward from an uppermost surface of the port body, extending away from the access port.
[0006] In some embodiments, an upper surface of the continuous rim defines an uppermost surface of the vascular access port.
[0007] In some embodiments, the barrier including the continuous rim is formed of a compliant material selected from a plastic, a polymer, an elastomer, an organic or synthetic rubber, or a silicone rubber.
[0008] In some embodiments, the continuous rim includes an outer surface extending between an uppermost edge and a radially outermost edge and an inner surface extending between the uppermost edge and the central transverse axis.
[0009] In some embodiments, the outer surface defines a concave cross-sectional profile.
[0010] In some embodiments, the outer surface defines a convex cross-sectional profile.
[0011] In some embodiments, the outer surface defines a continuous incline relative to the central transverse axis.
[0012] In some embodiments, the inner surface defines a convex cross-sectional profile.
[0013] In some embodiments, the inner surface comprises an S-shaped cross-sectional profile comprising a convex segment and a concave segment.
[0014] In some embodiments, the inner surface includes one of a discontinuous change in slope or a continuous change in slope.
[0015] In some embodiments, one or both of the outer surface and the inner surface include vertical segments extending parallel to the central transverse axis.
[0016] In some embodiments, the concave surface includes a portion that extends below an uppermost surface of the port body.
[0017] In some embodiments, the barrier includes a flange extending radially outward from a side surface of the barrier.
[0018] In some embodiments, the port is configured for subcutaneous deployment and further comprises a catheter coupled to the port shaft and in fluid communication with the reservoir, the distal tip of the catheter being deployed within the vasculature.
[0019] Also disclosed herein is a method of manufacturing a vascular access port, comprising: forming a port body defining a reservoir; and coupling a barrier to the port body, the barrier being positioned above the reservoir and having: a top surface having a concave portion and configured to be penetrated by a needle to allow fluid communication between the needle and the reservoir; and a continuous rim extending around a central lateral axis of the concave surface.
[0020] In some embodiments, the barrier defines a radially symmetrical shape extending about a central transverse axis.
[0021] In some embodiments, the continuous rim extends laterally outward from an uppermost surface of the port body, extending away from the port body.
[0022] In some embodiments, an upper surface of the continuous rim defines an uppermost surface of the vascular access port.
[0023] In some embodiments, the barrier including the continuous rim is formed of a compliant material selected from a plastic, a polymer, an elastomer, an organic or synthetic rubber, or a silicone rubber.
[0024] In some embodiments, the continuous rim includes an outer surface extending between an uppermost edge and a radially outermost edge, and an inner surface extending between the uppermost edge and the central lateral axis.
[0025] In some embodiments, the outer surface defines a concave cross-sectional profile.
[0026] In some embodiments, the outer surface defines a convex cross-sectional profile.
[0027] In some embodiments, the outer surface defines a continuous slope.
[0028] In some embodiments, the inner surface defines a convex cross-sectional profile.
[0029] In some embodiments, the inner surface comprises an S-shaped cross-sectional profile comprising a convex segment and a concave segment.
[0030] In some embodiments, the inner surface includes one of a discontinuous change in slope or a continuous change in slope.
[0031] In some embodiments, one or both of the outer surface and the inner surface include vertical segments extending parallel to the central transverse axis.
[0032] In some embodiments, the concave surface includes a portion that extends below an uppermost surface of the port body.
[0033] In some embodiments, the barrier includes a flange extending radially outward from a side surface of the barrier.
[0034] Also disclosed herein is a method of accessing a vascular access port, comprising: palpating a septum of the vascular access port to determine an edge of the septum and a concave center point of the septum, wherein the edge defines an edge of the vascular access port; inserting an access needle into the center point of the septum; penetrating the septum; and accessing a reservoir of the vascular access port to provide fluid communication with the needle.
[0035] In some embodiments, the rim extends continuously around a transverse center point of the barrier.
[0036] In some embodiments, the diameter of the topmost edge of the barrier is equal to or less than the lateral diameter of the reservoir.
[0037] In some embodiments, the concave center point of the septum extends laterally below the uppermost edge of the body of the vascular access port. BRIEF DESCRIPTION OF THE DRAWINGS
[0038] A more specific description of the disclosure will be presented by reference to specific embodiments of the disclosure illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and, therefore, should not be considered as limiting the scope of the invention. Exemplary embodiments of the invention will be described and explained with additional particularity and detail through the use of the accompanying drawings, in which:
[0039] Figure 1A A perspective view of a port including a palpable concave septum is shown according to embodiments disclosed herein.
[0040] Figure 1B Shown is a cross-sectional view of a port including a palpable concave septum according to embodiments disclosed herein.
[0041] Figure 2A A perspective view of a port including a palpable concave septum is shown according to embodiments disclosed herein.
[0042] Figure 2B Shown is a cross-sectional view of a port including a palpable concave septum according to embodiments disclosed herein.
[0043] Figure 3A A perspective view of a port including a palpable concave septum is shown according to embodiments disclosed herein.
[0044] Figure 3B Shown is a cross-sectional view of a port including a palpable concave septum according to embodiments disclosed herein.
[0045] Figure 4A A perspective view of a port including a palpable concave septum is shown according to embodiments disclosed herein.
[0046] Figure 4B Shown is a cross-sectional view of a port including a palpable concave septum according to embodiments disclosed herein.
[0047] Figure 5 Shown is a cross-sectional view of a palpable concave barrier according to embodiments disclosed herein.
[0048] Figure 6 Shown is a cross-sectional view of a palpable concave barrier according to embodiments disclosed herein.
[0049] Figure 7 Shown is a cross-sectional view of a palpable concave barrier according to embodiments disclosed herein.
[0050] Figure 8 Shown is a cross-sectional view of a palpable concave barrier according to embodiments disclosed herein. DETAILED DESCRIPTION
[0051] 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 provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiments, and these features may be optionally combined with or replace the features of any of the many other embodiments disclosed herein. It should be understood that the drawings are schematic and schematic representations of exemplary embodiments of the present invention, and are neither limited nor necessarily drawn to scale.
[0052] About the terms used herein, it should also be understood that these terms are for the purpose of describing some specific embodiments, and these terms do not 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 in a set of features or steps, and do not provide sequence or numerical restrictions. For example, "first", "second" and "third" features or steps do not necessarily appear in this order, and the specific embodiments including such features or steps are not necessarily limited to these three features or steps. For convenience, labels such as "left", "right", "top", "bottom", "front", "back", etc. are used, and these labels are not intended to imply, for example, any specific fixed position, orientation or direction. On the contrary, such labels are used to reflect, for example, relative position, orientation or direction. The singular form of "a kind of", "one" and "the" includes plural references unless the context clearly stipulates otherwise. In addition, the words "comprise", "have" and "contain" as used herein (including claims) should have the same meaning as the word "comprise".
[0053] In the following description, the terms "or" and "and / or" as used herein should be interpreted as inclusive or meaning any one or any combination. As an example, "A, B or C" or "A, B and / or C" means "any of the following: A; B; C; A and B; A and C; B and C; A, B and C". Exceptions to this definition will only occur when a combination of elements, parts, functions, steps or actions are inherently mutually exclusive in some way.
[0054] With respect to "proximal", for example, a "proximal portion" or "proximal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be placed near a clinician when the catheter is used in a patient. Similarly, for example, a "proximal length" of a catheter includes a length of the catheter that is intended to be placed near a clinician when the catheter is used in a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be placed near a clinician when the catheter is used in a patient. The proximal portion, proximal portion, or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context otherwise indicates, the proximal portion, proximal portion, or proximal length of a catheter is not the terminal portion or terminal length of a catheter.
[0055] 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 placed near or within the patient when the catheter is used in a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be placed near or within the patient when the catheter is used in a patient. For example, the "distal end" of a catheter includes the end of the catheter that is intended to be placed near or within the patient when the catheter is used in a patient. The distal portion, distal portion, or distal length of a catheter may include the distal end of the catheter; however, the distal portion, distal portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context otherwise indicates, the distal portion, distal portion, or distal length of a catheter is not the terminal portion or terminal length of a catheter.
[0056] To help describe the embodiments described herein, Figure 1A As shown, the longitudinal axis extends substantially parallel to the axial length of the shaft of the port. The lateral axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal axis and the lateral axis. The vertical axis may extend parallel to the transverse axis. The horizontal axis may extend perpendicular to the vertical axis. The horizontal plane may be defined by the longitudinal axis and the lateral axis. The vertical plane may extend perpendicular to the horizontal plane.
[0057] As used herein, a "top" or "upper" surface or direction is a surface or direction extending along the transverse axis that is relatively closer to the skin surface when the port 100 is placed subcutaneously, i.e., a surface or direction that is relatively farther from the base 106 of the port 100. Similarly, a "bottom" or "lower" surface or direction is a surface or direction extending along the transverse axis that is relatively farther from the skin surface when the port 100 is placed subcutaneously, i.e., a surface or direction that is relatively closer to the base 106 of the port 100.
[0058] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art.
[0059] Figure 1A to Figure 1B An embodiment of a subcutaneous vascular access device or "port" 100 is shown, which generally includes a port body 102 defining a reservoir 104 and including a port shaft 110. The port shaft 110 can extend from the port body 102 along a longitudinal axis and can define a shaft lumen 112 in fluid communication with the reservoir 104.
[0060] In one embodiment, the body 102 can include a base portion ("base") 106 and a housing 108. The housing 108 can be formed of the same material as the base 106 or a different material. In one embodiment, the housing 108 can be overmolded onto the base 106. In one embodiment, the housing 108 can be engaged with the base 106 in one or more of a press fit, a snap fit, or an interference fit engagement. In one embodiment, the housing 108 can be secured to the base 106 using an adhesive, bonding, welding, ultrasonic welding, etc. In one embodiment, one of the base 106 or the housing 108 can define a reservoir 104. In one embodiment, the base 106 and the housing 108 can cooperate to define the reservoir 104.
[0061] In one embodiment, the body 102 can define a lateral height (hi) extending between a bottom-most surface and a top-most surface of the body 102. As described above, the port 100 can be designed to maintain as low a lateral height (hi) profile as possible to reduce skin stretching when placed subcutaneously and to reduce skin erosion.
[0062] In one embodiment, the port 100 can also include a needle-penetrable septum 120 disposed above the reservoir 104 and 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 can extend laterally through the skin surface and can penetrate the septum 120 to provide fluid communication with the reservoir 104. The fluid can then pass through the access needle, into the reservoir 104, through the port shaft lumen 112, and into the lumen of a catheter coupled to the port shaft 110. The distal tip of the catheter can be disposed within the patient's vasculature.
[0063] In one embodiment, barrier 120 may define a radially symmetrical shape extending about central transverse axis 90. Figure 1BAs shown, the cross-sectional profile of the upper surface of the barrier 120 can extend between the central transverse axis 90 and the radially outermost edge 94. In one embodiment, at least a portion (e.g., a central portion) of the top surface of the barrier 120 can define a concave shape. Thus, the uppermost or topmost edge 92 of the barrier 120 can be disposed radially outward from the central transverse axis 90 to define a palpation ring 124. In one embodiment, the entire upper surface of the barrier 120 can define a concave surface. As used herein, the topmost edge is an edge or surface disposed laterally outermost and away from the base 106 of the port 100.
[0064] In one embodiment, a portion of the top surface of the septum 120 disposed at the central transverse axis 90 can be laterally aligned with the topmost edge of the port body 102. Thus, the palpation ring 124 can extend a second height (h2) from the topmost surface of the port body 102. In one embodiment, the septum 120 can be formed of a relatively compliant material, such as a plastic, a polymer, an elastomer, an organic or synthetic rubber, a silicone rubber, or the like.
[0065] It should be noted that when the port 100 is placed subcutaneously, the skin surface tissue stretches and expands on the port 100 to accommodate the lateral height of the port 100. Skin erosion can occur where the skin surface tissue contacts the top edge of the port 100 and stretches thereon. Low-profile ports (i.e., ports with reduced lateral height) have been developed to reduce stretching and skin erosion. As described herein, the top edge of the port 100 can be defined by the top edge 92 of the palpation ring 124, which is formed by the relatively compliant material of the barrier 120. Therefore, the compliant palpation ring 124 can be elastically deformed to disperse the pressure on the skin surface tissue and reduce skin erosion.
[0066] In one embodiment, the barrier 120 can include a flange 122 extending from a side surface of the barrier 120 and extending annularly about the central transverse axis 90. The flange 122 can engage the channel 114 defined by the port body 102 to secure the barrier 120 in place over the reservoir 104. In one embodiment, the base 106 and the housing 108 can cooperate to define the channel 114.
[0067] In one embodiment, the cross-sectional profile of the palpation ring 124 can define an inner surface 128 and an outer surface 126. The inner surface 128 of the palpation ring 124 can extend from the central transverse axis 90 to the topmost edge 92. The outer surface 126 of the palpation ring 124 can extend from the topmost edge 92 to the outermost edge 94. As previously described, the barrier 120 defines a radially symmetrical shape about the central transverse axis 90.
[0068] like Figure 1B As shown, in one embodiment, the inner surface 128 of the palpation ring 124 can define a concave cross-sectional shape. In one embodiment, the outer surface 126 of the palpation ring 124 can define a convex cross-sectional shape. Advantageously, the convex shape of the outer surface 126 of the palpation ring 124 can further disperse the pressure on the skin surface tissue stretched on the port 100 and can reduce skin erosion when the port is placed subcutaneously.
[0069] When the port 100 is placed subcutaneously, the palpation ring 124 of the septum 120 can extend laterally outward from the port 100, away from the port body 102, and can be palpated by a user to determine the position of the port 100. More specifically, the palpation ring 124 can provide a concave center portion for the top surface of the septum 120. Advantageously, the concave top surface of the septum 120 can guide a user's finger and / or access needle toward the central transverse axis 90 and align the finger or access needle with the reservoir 104 disposed laterally below the septum 120.
[0070] In one embodiment, the topmost edge 92 of the palpation ring 124 can be aligned laterally with, or just inside, the vertical wall of the reservoir 104. Thus, the palpation ring 124 can indicate the horizontal footprint of the reservoir 104 disposed below. Advantageously, the concave surface of the barrier 120 defined by the topmost edge 92 of the palpation ring 124 can indicate the location of the reservoir 104 to the user, and the user can select a location within the palpation ring 124 to enter the reservoir 104 using an access needle.
[0071] Penetrating the septum 120 with an access needle within the topmost edge 92 of the septum 120 can ensure that the access needle can enter the reservoir 104. In other words, the horizontal surface area of the inner surface 128 of the septum 120 can be equal to or slightly less than the horizontal surface area of the reservoir 104. Therefore, penetrating the septum at any point within the inner surface 128 defined by the topmost edge 92 can ensure that the user can enter the reservoir 104. In one embodiment, the radially outermost edge 94 of the palpation ring 124 can extend beyond the radially outermost edge of the reservoir 104. In other words, the horizontal surface area defined by the palpation ring 124 can be equal to or slightly greater than the horizontal surface area of the reservoir 104. In one embodiment, the outer surface 126 of the palpation ring 124 can define a smooth transition surface between the outer surface of the port body 102 and the palpation ring 124, and can reduce stretching or skin erosion.
[0072] In one embodiment, if Figure 1BAs shown, the cross-sectional shape of the inner surface 128 of the palpation ring 124 can define a relatively steep slope near the topmost edge 92 before gradually decreasing to a relatively shallow slope toward the central transverse axis 90. Therefore, the inner surface 128 of the palpation ring 124 can define a relatively wide bowl shape and can provide a relatively large horizontal surface area over which a user can penetrate the barrier 120 to enter the reservoir 104. Advantageously, the relatively wide inner surface 128 of the palpation ring 124 can allow a user to enter the reservoir at different locations, thereby mitigating the formation of scar tissue or degradation of skin surface tissue disposed thereon due to repeated entry. As used herein, the "slope" of a surface is defined relative to a horizontal plane.
[0073] FIG. 2A to FIG. 2B An embodiment of the port 100 is shown that includes a barrier 120 having a concave top surface and a palpation ring 224. The palpation ring 224 can define an outer surface 226 extending between the uppermost edge 92 and the radially outermost edge 94, and an inner surface 228 extending between the uppermost edge 92 and the central transverse axis 90, as described herein.
[0074] In one embodiment, the cross-sectional shape of the inner surface 228 of the palpation ring 220 can define a relatively more consistent slope extending between the topmost edge 92 and the central transverse axis 90. Advantageously, the relatively consistent slope of the inner surface 228 can guide the user toward the central transverse axis 90 and promote accuracy when entering the reservoir 104. This can be particularly important when accessing a reduced size port system (e.g., a port system deployed in a limb such as an arm, etc.).
[0075] In one embodiment, the outer surface 226 of the palpation ring 224 extends radially outward from the topmost edge 92 of the palpation ring 224 to the radially outermost edge 94, which can define a concave cross-sectional shape. In one embodiment, the segments of the outer surface 226 disposed near the topmost edge 92 can define a relatively steep slope before gradually decreasing to a relatively shallow slope near the radially outermost edge 94. In one embodiment, the segments of the outer surface 226 disposed near the topmost edge 92 can define a substantially vertical slope before gradually decreasing to a relatively shallow slope near the radially outermost edge 94. Advantageously, the concave outer surface 226 of the palpation ring 224 can reduce the contact surface area between the palpation ring outer surface 226 and the skin surface tissue extending above the port 100, thereby reducing contact therebetween and reducing skin erosion. Advantageously, the concave outer surface 226 of the palpation ring 224 including steep or vertical segments can provide improved definition of the palpation ring 224, thereby providing a palpation feature that is easier to identify when placed subcutaneously.
[0076] FIG. 3A to FIG. 3B An embodiment of the port 100 is shown, which includes a barrier 120 having a concave top surface and a palpation ring 324. The palpation ring 324 can define an outer surface 326 extending between the uppermost edge 92 and the radially outermost edge 94, and an inner surface 328 extending between the uppermost edge 92 and the central transverse axis 90, as described herein. In one embodiment, the outer surface 326 of the palpation ring 324 can define a concave cross-sectional shape. In one embodiment, a segment of the outer surface 326 disposed near the uppermost edge 92 can define a relatively steep or vertical slope before gradually decreasing to a relatively shallow slope near the radially outermost edge 94.
[0077] In one embodiment, the inner surface 328 of the palpation ring 324 can also define a relatively steep or vertical segment near the topmost edge 92 before gradually decreasing to a relatively shallow slope near the central vertical axis 90. Advantageously, the vertical segments of the inner surface 328 and the outer surface 326 disposed on either side of the topmost edge 92 can define a distinct palpation ring 324 to facilitate palpation of the port 100 when it is placed subcutaneously. In addition, the concave inner surface 328 and the concave outer surface 326 can provide a reduced contact surface area between the port 100 and the skin tissue disposed thereon to reduce skin erosion.
[0078] FIG. 4A to FIG. 4B An embodiment of a port 100 is shown that includes a barrier 120 having a concave top surface and a palpation ring 424. The palpation ring 424 can define an outer surface 426 extending between the uppermost edge 92 and the radially outermost edge 94, and an inner surface 428 extending between the uppermost edge 92 and the central transverse axis 90, as described herein.
[0079] In one embodiment, the outer surface 426 of the palpation ring 424 can extend at a substantially continuous slope between the topmost edge 92 and the radially outermost edge 94 to define a frustoconical shape of the palpation ring 124. Advantageously, the outer surface 426 can provide a smooth transition between the port body 102 and the topmost edge 92 of the palpation ring 424 to relieve pressure points on skin surface tissue stretched thereon and reduce skin erosion.
[0080] In one embodiment, the inner surface 428 of the palpation ring 424 can define a concave cross-sectional profile and can include a vertical segment disposed near the topmost edge 92. The inner surface 428 can then provide a continuous change in inclination between the vertical segment and the central vertical axis 90 to provide a rounded concave segment for the inner surface 416 of the palpation ring 424. Advantageously, the inner surface 428 can both guide the user toward the central transverse axis 90 and provide a relatively large horizontal surface area to access the reservoir 104 at different locations, thereby reducing scar tissue accumulation caused by repeated needling at the same location.
[0081] Figures 5 to 8 A cross-sectional view of an embodiment of a barrier 120 for use with a low profile port 100 is shown, the barrier including a concave segment toward the top surface and a palpation ring. Generally speaking, the barrier 120 can define a radially symmetrical shape and include a concave segment toward the upper surface extending between a topmost edge 92 and a central transverse axis 90. Thus, the topmost edge 92 can define a palpation ring that extends continuously around the central transverse axis 90, as described herein. In one embodiment, the palpation ring can include an inner surface extending between the topmost edge 92 and the central transverse axis 90, and an outer surface extending between the topmost edge 92 and a radially outermost edge 94, as described herein. In one embodiment, the topmost edge 92 of the palpation ring can extend laterally outward from the topmost edge of the port body 102 to overall define the topmost edge of the port 100.
[0082] In one embodiment, a portion of the inner surface can extend laterally below the topmost edge of the port body 102. Thus, the top surface of the barrier 120 can define a concave surface that extends over a lateral height (h2) while reducing the overall lateral height of the port 100 (i.e., height of the port 100 = < height (h1) + height (h2)). Advantageously, the overall lateral height of the port 100 can be reduced without reducing the effectiveness (depth) of the palpation ring and concave segment for palpation.
[0083] Figure 5 An embodiment of a barrier 120 is shown that includes a concave segment and a palpation ring 524. An outer surface 526 of the palpation ring 524 can define a convex cross-sectional profile. An inner surface 528 of the palpation ring 524 can define an S-shaped curved cross-sectional profile that curves in a first direction near the topmost edge 92 before transitioning through an inflection point and curves in a second direction opposite to the first direction near the central transverse axis 90.
[0084] Figure 6An embodiment of a barrier 120 is shown that includes a concave segment and a palpation ring 624. An outer surface 626 of the palpation ring 624 can define a consistent slope between the topmost edge 92 and the outermost edge 94. An inner surface 628 of the palpation ring 624 can define a consistent change in slope between a relatively steep or vertical slope near the topmost edge 92 and a relatively shallow slope near the central transverse axis 90.
[0085] Figure 7 An embodiment of a barrier 120 is shown that includes a concave segment and a palpation ring 724. An outer surface 726 of the palpation ring 724 can include a substantially vertical segment near the topmost edge 92 and a convex segment near the outermost edge 94. An inner surface 728 of the palpation ring 724 can include a consistent change in slope between a relatively steep slope near the topmost edge 92 and a relatively shallow slope near the central transverse axis 90.
[0086] Figure 8 An embodiment of a barrier 120 is shown that includes a concave segment and a palpation ring 824. An outer surface 826 of the palpation ring 824 can include a consistent slope between the topmost edge 92 and the outermost edge 94. An inner surface 828 of the palpation ring 824 can include a substantially vertical segment near the topmost edge 92 and a segment that includes a consistent change in slope between a relatively steep slope near the topmost edge 92 and a relatively shallow slope near the central transverse axis 90.
[0087] Although some specific embodiments have been disclosed herein, and although these specific embodiments have been disclosed in considerable detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be envisioned by those of ordinary skill in the art, and in broader aspects, these adaptations and / or modifications are also encompassed. Therefore, changes may be made to 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; and a barrier positioned above the reservoir and captured by the port body, the barrier comprising: a concave top surface configured to be penetrated by a needle to allow fluid communication between the needle and the reservoir; and A continuous rim extends about a central transverse axis of the concave surface.
2. The vascular access port of claim 1, wherein the barrier defines a radially symmetrical shape extending about the central transverse axis.
3. The vascular access port of claim 1 or 2, wherein the continuous rim extends laterally outward from an uppermost surface of the port body.
4. The vascular access port of any one of claims 1 to 3, wherein an upper surface of the continuous rim defines an uppermost surface of the vascular access port.
5. The vascular access port of any one of claims 1 to 4, wherein the barrier including the continuous rim is formed of a compliant material selected from the group consisting of plastics, polymers, elastomers, organic or synthetic rubbers, or silicone rubbers.
6. The vascular access port of any one of claims 1 to 5, wherein the continuous rim comprises an outer surface extending between an uppermost edge and a radially outermost edge and an inner surface extending between the uppermost edge and the central transverse axis.
7. The vascular access port of claim 6, wherein the outer surface defines a concave cross-sectional profile.
8. The vascular access port of claim 6, wherein the outer surface defines a convex cross-sectional profile.
9. The vascular access port of claim 6, wherein the outer surface defines a continuous incline relative to the central transverse axis.
10. The vascular access port of any one of claims 6 to 9, wherein the inner surface defines a convex cross-sectional profile.
11. The vascular access port of any one of claims 6 to 9, wherein the inner surface comprises an S-shaped cross-sectional profile comprising a convex segment and a concave segment.
12. The vascular access port of any one of claims 6 to 11, wherein the inner surface comprises one of a discontinuous change in slope or a continuous change in slope.
13. The vascular access port of any one of claims 6 to 12, wherein one or both of the outer surface and the inner surface include a vertical segment extending parallel to the central transverse axis.
14. The vascular access port of any one of claims 1 to 13, wherein the concave surface includes a portion extending below an uppermost surface of the port body.
15. The vascular access port of any one of claims 1 to 14, wherein the barrier comprises a flange extending radially outward from a side surface of the barrier.
16. The vascular access port of any one of claims 1 to 15, wherein the port is configured for subcutaneous deployment and further comprises a catheter coupled to the port shaft and in fluid communication with the reservoir, the distal tip of the catheter being deployed within the vasculature.
17. A method of manufacturing a vascular access port, comprising: forming a port body defining a reservoir; and A barrier is coupled to the port body, the barrier being positioned above the reservoir and comprising: a top surface having a concave portion and configured to be penetrated by a needle to allow fluid communication between the needle and the reservoir; and A continuous rim extends about a central transverse axis of the concave surface.
18. The method of claim 17, wherein the barrier defines a radially symmetrical shape extending about the central transverse axis.
19. The method of claim 17 or 18, wherein the continuous rim extends laterally outwardly from an uppermost surface of the port body.
20. The method of any one of claims 17 to 19, wherein an upper surface of the continuous rim defines an uppermost surface of the vascular access port.
21. The method of any one of claims 17 to 20, wherein the barrier including the continuous edge is formed of a compliant material selected from the group consisting of plastic, polymer, elastomer, organic or synthetic rubber, or silicone rubber.
22. The method of any one of claims 17 to 21, wherein the continuous rim comprises an outer surface extending between an uppermost edge and a radially outermost edge and an inner surface extending between the uppermost edge and the central transverse axis.
23. The method of claim 22, wherein the outer surface defines a concave cross-sectional profile.
24. The method of claim 22, wherein the outer surface defines a convex cross-sectional profile.
25. The method of claim 22, wherein the outer surface defines a continuous slope.
26. A method according to any one of claims 22 to 25, wherein the inner surface defines a convex cross-sectional profile.
27. The method of any one of claims 22 to 25, wherein the inner surface comprises an S-shaped cross-sectional profile comprising a convex segment and a concave segment.
28. The method of any one of claims 22 to 27, wherein the inner surface comprises one of a discontinuous change in slope or a continuous change in slope.
29. The method of any one of claims 22 to 28, wherein one or both of the outer surface and the inner surface include vertical segments extending parallel to the central transverse axis.
30. The method of any one of claims 17 to 29, wherein the concave surface includes a portion extending below an uppermost surface of the port body.
31. The method of any one of claims 17 to 30, wherein the barrier comprises a flange extending radially outwardly from a side surface of the barrier.
32. A method of accessing a vascular access port, comprising: palpating a barrier of the vascular access port to determine an edge of the barrier and a concave center point of the barrier, wherein the edge defines a topmost edge of the vascular access port; inserting an access needle into a center point of the barrier; penetrating the barrier; and A reservoir is accessed into the vascular access port to provide fluid communication with the needle.
33. The method of claim 32, wherein the edge extends continuously around a transverse center point of the barrier.
34. A method according to claim 32 or 33, wherein the diameter of the topmost edge of the barrier is equal to or less than the lateral diameter of the reservoir.
35. The method of any one of claims 32 to 34, wherein the concave center point of the barrier extends laterally below an uppermost edge of a body of the vascular access port.