In-line dual lumen port for direct fluid path

Abstract

The embodiments disclosed herein relate to a dual in-line port having a direct fluid path between a proximal reservoir and a stem. The port includes a conduit that passes through a distal reservoir and defines a lumen in fluid communication with the proximal reservoir and the stem. The axis of the conduit lumen is aligned with the stem lumen to minimize a tortuous fluid path and reduce fluid flow resistance. The port may further include a needle guard that extends over the distal reservoir and is configured to prevent an access needle from impacting the conduit when accessing the distal reservoir. The embodiments may further include a removable reservoir insert that defines the distal reservoir.

Description

[Technical Field]

[0001] The present disclosure relates to a direct fluid path for an in-line dual lumen port. [Background technology]

[0002] Briefly summarized, embodiments disclosed herein relate to dual-reservoir in-line ports with a direct fluid path between the reservoirs and the port stem. Dual in-line ports may be preferable to parallel dual-port configurations because the in-line configuration requires a relatively small incision site during subcutaneous placement. However, the fluid path between the reservoir farthest from the stem (the "proximal" reservoir) and the stem lumen may be tortuous. A tortuous fluid path may increase fluid resistance or reduce fluid flow. Alternatively, if the fluid path extends below the reservoir adjacent to the stem (the "distal" reservoir), the overall height of the port may increase, potentially stretching the skin or eroding skin tissue, resulting in port exposure. Summary of the Invention

[0003] Disclosed herein is a vascular access port comprising: a body including a stem, the stem extending longitudinally distally from the body and defining a first stem lumen and a second stem lumen; a distal reservoir disposed adjacent to the port stem and in fluid communication with the first stem lumen; a proximal reservoir disposed adjacent to the distal reservoir and in fluid communication with a conduit extending through the distal reservoir, thereby providing fluid communication with the second stem lumen; a septum disposed on one or both of the distal and proximal reservoirs; and a needle guard extending over the distal reservoir and configured to prevent a needle from contacting the conduit.

[0004] In some embodiments, the needle guard extends over a portion of the septum. In some embodiments, the needle guard penetrates a portion of the septum. In some embodiments, the needle guard extends below the septum and above the distal reservoir. In some embodiments, the axis of the conduit is aligned with the axis of the second stem lumen. In some embodiments, the proximal reservoir is positioned on the opposite side of the distal reservoir from the port stem. In some embodiments, the port stem, distal reservoir, and proximal reservoir are positioned along a linear axis.

[0005] In some embodiments, the vascular access port further includes a housing disposed over one or both of the body and the septum and configured to secure the septum in place over one or both of the distal and proximal reservoirs. In some embodiments, the housing is formed from a compliant material and is overmolded onto the body. In some embodiments, the housing is formed from a rigid material and is secured to the body with an interference fit, press fit, or snap fit engagement. In some embodiments, the vascular access port further includes a base configured to engage the housing and secure one or both of the body and the septum therebetween. In some embodiments, the housing includes one or more septum openings aligned along the transverse axis with one or both of the distal and proximal reservoirs, and a portion of the septum extends through the septum opening. In some embodiments, the body defines a recess configured to receive a reservoir insert, and the reservoir insert defines the distal reservoir.

[0006] Also disclosed herein is a subcutaneous port system including: a body defining a proximal reservoir and a recess; a reservoir insert defining a distal reservoir and configured to fit within the recess; and a stem including a first lumen in fluid communication with the distal reservoir and a second lumen in fluid communication with the proximal reservoir.

[0007] In some embodiments, the subcutaneous port system further includes a septum disposed on one or both of the proximal reservoir and the distal reservoir. In some embodiments, the subcutaneous port system further includes a housing disposed on one or both of the body and the septum and configured to secure the septum in place on one or both of the proximal reservoir and the distal reservoir. In some embodiments, the reservoir insert includes a conduit extending through the distal reservoir from a first wall to a second wall opposite the first wall, the conduit defining a conduit lumen configured to provide fluid communication between the proximal reservoir and the second stem lumen. In some embodiments, the axis of the conduit lumen is aligned with the axis of the second stem lumen, providing a straight-line fluid path between the proximal reservoir and the distal tip of the stem.

[0008] In some embodiments, the recess includes a channel disposed in a sidewall of the recess and extending circumferentially between the first stem lumen and a proximal conduit opening communicating with the proximal reservoir, the reservoir insert disposed in the recess cooperating with the channel to define a curved conduit providing fluid communication between the proximal reservoir and the second stem lumen. In some embodiments, the subcutaneous port system further includes an access needle and a needle guard extending over the distal reservoir and aligned with the conduit, the needle guard configured to prevent the needle from contacting the conduit.

[0009] Also disclosed herein is a method of manufacturing a port, the method including the steps of: forming a body having a proximal reservoir, a distal reservoir, and a stem; forming a conduit extending through the distal reservoir from the proximal reservoir to the stem, thereby providing fluid communication between the proximal reservoir and the stem; forming a needle guard extending over the conduit and configured to prevent the needle from impacting the conduit; coupling a septum disposed over one or both of the proximal and distal reservoirs to the body; and coupling a housing to one or both of the body and the septum to secure the septum to the body.

[0010] In some embodiments, the housing defines a septum opening aligned with the distal reservoir along a transverse axis, and the needle guard is coupled to the housing and extends across the septum opening. In some embodiments, the septum includes a groove extending longitudinally through an upper surface of the septum, the groove configured to receive the needle guard. In some embodiments, the needle guard is integrally formed with and extends through the septum. In some embodiments, the needle guard is coupled to the body and extends from a first edge of the distal reservoir to a second edge of the distal reservoir opposite the first edge. In some embodiments, the method further includes forming a reservoir insert defining the distal reservoir, the reservoir insert configured to fit within a recess defined in the body, and the reservoir insert configured to be removable and replaceable with a second reservoir insert.

[0011] The present disclosure will be described in more detail by reference to specific embodiments that are 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 limiting of its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0012] [Figure 1A] FIG. 1 is a perspective view of a dual in-line port with a direct fluid path according to an embodiment disclosed herein. [Figure 1B] FIG. 10 is an exploded view of a dual in-line port with a direct fluid path according to an embodiment disclosed herein. [Figure 2A] 1B is a perspective view of the body of the port of FIG. 1A according to an embodiment disclosed herein. [Figure 2B] 1B is a perspective view of the body of the port of FIG. 1A according to an embodiment disclosed herein. [Figure 2C]1B is a top view of the body of the port of FIG. 1A according to an embodiment disclosed herein. [Figure 2D] 1B is a side view of the body of the port of FIG. 1A according to an embodiment disclosed herein. [Figure 2E] 1B is a bottom perspective view of the body of the port of FIG. 1A according to an embodiment disclosed herein. FIG. [Figure 2F] FIG. 1 is a perspective view of a body of a dual in-line port having a direct fluid path and including a needle guard according to an embodiment disclosed herein. [Figure 3A] 1B is a perspective view of the stem of the port of FIG. 1A according to an embodiment disclosed herein. [Figure 3B] 1B is a plan view of the stem of the port of FIG. 1A according to an embodiment disclosed herein. [Figure 4A] 1B is a top view of a septum of the port of FIG. 1A according to an embodiment disclosed herein. [Figure 4B] 1B is a side view of a septum of the port of FIG. 1A according to an embodiment disclosed herein. [Figure 5A] 1B is a perspective view of a housing of the port of FIG. 1A according to an embodiment disclosed herein. [Figure 5B] 1B is a perspective view of the base of the port of FIG. 1A according to an embodiment disclosed herein. [Figure 5C] 1B is a bottom perspective view of a housing of the port of FIG. 1A according to an embodiment disclosed herein. FIG. [Figure 6] 1A-1C illustrate embodiments of a body of a port having a direct in-line fluid path including a reservoir insert according to embodiments disclosed herein. [Figure 7A] 1 is a cross-sectional plan view of a port having a curved fluid path according to an embodiment disclosed herein. [Figure 7B] FIG. 1 is a cross-sectional plan view of a port having a direct in-line fluid path according to an embodiment disclosed herein. [Figure 8A] 7 is a perspective view of a reservoir insert of the port of FIG. 6 according to an embodiment disclosed herein. [Figure 8B]7 is a perspective view of a reservoir insert of the port of FIG. 6 according to an embodiment disclosed herein. [Figure 8C] 7 is a distal end view of a reservoir insert of the port of FIG. 6 according to an embodiment disclosed herein. [Figure 8D] 7 is a top view of a reservoir insert of the port of FIG. 6 according to an embodiment disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0013] 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 readily separated from the specific embodiment and that may be optionally combined with or substituted for features of any of the other embodiments disclosed herein.

[0014] With regard to the terms used herein, it should also be understood that each term is intended to describe certain specific 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 within a group of features or steps, and do not impose any order or numerical limitations. For example, "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 need not necessarily be limited to three features or steps. Designations such as "left," "right," "top," "bottom," "front," and "back" are used for convenience and do not, for example, imply any particular fixed position, orientation, or direction. Rather, such designations are used to indicate, for example, relative position, orientation, or direction. Unless the context clearly indicates otherwise, the singular forms "a," "an," and "the" include the plural.

[0015] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter that is closest to the physician 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 closest to the physician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is closest to the physician 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 terminal portion or length of the catheter.

[0016] With respect to "distal," for example, the "distal portion" or "distal end portion" of a catheter disclosed herein includes the portion of the catheter that is near or within a patient when the catheter is in use with the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is near or within the patient when the catheter is in use with the patient. For example, the "distal end" of a catheter includes the end of the catheter that is near or within the patient when the catheter is in use with the patient. Although the distal portion, distal end portion, or distal length of a catheter may include the distal end of the catheter, 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 terminal portion or terminal length of the catheter.

[0017] To aid in describing the embodiments described herein, as shown in FIG. 1A, a longitudinal axis extends substantially parallel to the axial length of the stem 140. A transverse axis extends perpendicular to the longitudinal axis, and a transverse axis extends perpendicular to both the longitudinal and transverse axes. As used herein, a horizontal plane extends along the transverse and longitudinal axes. A vertical plane extends perpendicular to the horizontal plane.

[0018] 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 a dual in-line port (“port”) 100 having a direct fluid path. The port 100 may generally include a body 130 including a stem 140. The stem 140 extends from the body 130. The body 130 may define reservoirs 132, for example, a distal reservoir 132A disposed adjacent the stem 140 and a proximal reservoir 132B disposed adjacent the distal reservoir 132A on an opposite side of the stem 140. The port 100 may further include a septum 120 disposed over one of the distal reservoir 132A and the proximal reservoir 132B, and a body 110 disposed over the septum 120 and configured to secure the septum 120 in place relative to the body 130.

[0019] The stem 140 may extend along a longitudinal axis and be configured to be coupled to a proximal end of the catheter 90. The distal tip of the catheter 90 may be disposed within the patient's vasculature to provide fluid communication with the patient. Optionally, the catheter lock 80 may further secure the catheter 90 to the port stem 140. The stem 140 may define a stem lumen 142 in fluid communication with the reservoir 132.

[0020] In one embodiment, the body 130 may include a first reservoir, e.g., a distal reservoir 132A, in fluid communication with the first stem lumen 142A. A second reservoir, e.g., a proximal reservoir 132B, may be in fluid communication with a conduit 150 defining a conduit lumen 152. The conduit 150 may extend through the first distal reservoir 132A to provide fluid communication with the second stem lumen 142B. In one embodiment, the axis of the conduit lumen 152 may extend parallel to the longitudinal axis and be aligned with the axis of the second stem lumen 142B, thereby providing a direct fluid pathway extending between the proximal reservoir 132B and the distal tip of the second stem lumen 142B, as described in more detail herein.

[0021] In one embodiment, the port 100 may further include one or more needle-pierceable septa 120. In one embodiment, the port 100 may include a single septum 120 disposed over both the distal reservoir 132A and the proximal reservoir 132B. In one embodiment, the port 100 may include a first septum 120A disposed over the distal reservoir 132A and a second septum 120B disposed over the proximal reservoir 132B. The one or more septa 120 may be configured to provide percutaneous access to the reservoirs 132 disposed below the septum 120 via an access needle. For example, when the port 100 is positioned subcutaneously, the access needle may penetrate the skin surface and underlying tissue. The access needle may be forced through the needle-pierceable septum 120 and into the reservoirs 132 disposed below the septum 120. The access needle may then provide fluid communication with the reservoir 132 .

[0022] 1A and 1B and 5A-5C, the port 100 may further include a housing 110 disposed over one of the body 130 and the septum 120 and configured to secure the septum 120 in place relative to the body 130. In one embodiment, the housing 110 may comprise a rigid or elastic material, such as a resin, a polymer, a metal, an alloy, a composite material, or a combination thereof. In one embodiment, the housing 110 may comprise a compliant material, such as a resin, a polymer, an elastomer, a composite material, or a combination thereof.

[0023] In one embodiment, the housing 110 may include a base 112. The base 112 may be configured to engage the housing 110 with one of a press fit, a snap fit, and an interference fit engagement. In one embodiment, the base 112 may be coupled to the housing 110 by adhesive, bonding, welding, or the like. In one embodiment, the base 112 may be configured to engage a bottom edge or a bottom surface of the body 130 and secure the body 130 and / or the septum 120 between the base 112 and the housing 110. In one embodiment, one of the housing 110 and the base 112 may be overmolded onto one of the body 130 or the septum 120 and secure the septum 120 in place over the reservoir 132.

[0024] In one embodiment, the housing 110 and the base 112 may be formed of the same material. In one embodiment, the housing 110 and the base 112 may be formed of different materials exhibiting different mechanical properties. For example, the housing 110 may be formed of a relatively compliant material, and the base 112 may be formed of a relatively rigid material. In one embodiment, the housing 110 may include one or more septum openings 116, such as a distal septum opening 116A that may be aligned with the distal reservoir 132A along the transverse axis and a proximal septum opening 116B that may be aligned with the proximal reservoir 132B along the transverse axis. In one embodiment, a portion of the septum 120 may extend through the septum opening 116, as described in more detail herein.

[0025] In one embodiment, the housing 110 may include a palpation feature 118. The palpation feature 118 may be configured to be palpated by a physician when the port 100 is placed subcutaneously and to indicate the location of one of the distal reservoir 132A and the proximal reservoir 132B. In one embodiment, the housing 110 may include one or more suture holes 114 configured to allow the port 110 to be secured in place subcutaneously.

[0026] In one embodiment, the housing 110 may include a stem opening 170 aligned with the stem 140. The stem 140 may engage the body 130 by passing through the stem opening 170 in the housing 110, as described herein. In one embodiment, the housing 110 may include a housing stem recess 172, and the base 112 may include a base stem recess 174. The housing stem recess 172 and the base stem recess 174 may cooperate to form the stem opening 170 when the base 112 engages the housing 110.

[0027] In one embodiment, the port 100 may further include a needle guard 160 extending along the longitudinal axis and configured to prevent an access needle accessing the distal reservoir 132A from penetrating the conduit 150. The needle guard 160 may be formed from a needle-impermeable material, such as a resin, polymer, metal, alloy, composite, or combination thereof. In one embodiment, the needle guard 160 may be formed from the same material as one of the housing 110 and the body 130. The needle guard 160 may extend longitudinally over a portion of the distal reservoir 132A. For example, the needle guard 160 may extend from a proximal edge of the distal septum opening 116A to a distal edge of the distal septum opening 116A. The needle guard 160 may define a lateral width and a transverse height. In one embodiment, the lateral width of the needle guard 160 may be equal to, less than, or greater than the transverse height. In one embodiment, needle guard 160 may be integrally formed with housing 110. In one embodiment, needle guard 160 may be formed as a separate structure and coupled to housing 110 using adhesives, bonding, welding, or the like.

[0028] In one embodiment, needle guard 160 may penetrate a portion of septum 120, for example, a portion of distal septum 120A. In one embodiment, septum 120 may include a groove 162 configured to penetrate septum 120 and receive needle guard 160 therein. In one embodiment, as shown in FIGS. 4A and 4B , needle guard 160 may be integrally formed with septum 120, i.e., needle guard 160 may be disposed within septum 120. In one embodiment, needle guard 160 may be formed of a different material than septum 120. In one embodiment, septum 120 may be overmolded onto needle guard 160.

[0029] In one embodiment, needle guard 160 may extend below septum 120 and above reservoir 132. In one embodiment, needle guard 160 may be integrally formed with body 130 and may extend above distal reservoir 132A, as shown in FIG. 2F. In one embodiment, needle guard 160 may be formed as a separate structure and coupled to body 130 using adhesives, bonding, welding, etc.

[0030] 2A-2F show further details of the body 130 of the port 100. In one embodiment, the body 130 may include a rail 134 extending along the outer periphery of the body 130 and extending transversely axially upward from the body 130. In one embodiment, the outer periphery 124 of the septum 120 may fit within the rail 134, and the rail 134 may restrain lateral or longitudinal movement of the septum 120 relative to the body 130. In one embodiment, the outer periphery 124 of the septum 120 may be slightly larger than the inner periphery of the rail 134 along one of the horizontal axis, the vertical axis, or an axis extending at an angle between the horizontal and vertical axes. Thus, the rail 134 may engage the septum 120 with a press fit or interference fit, thereby securing the septum 120 in place on the reservoir 132.

[0031] 2E, the underside of body 130 may include one or more symbols, alphanumeric symbols, etc. engraved thereon. In one embodiment, radiopaque or acoustically opaque material may be disposed within the inscription so that the symbols are visible in medical images when port 100 is placed subcutaneously. Advantageously, the symbols may indicate characteristics of port 100 (e.g., CT-friendly, suitable for high-pressure injection, etc.) or may distinguish between distal reservoir 132A and proximal reservoir 132B, etc.

[0032] 3A and 3B show further details of the stem 140 of the port 100. In one embodiment, the stem 140 may be integrally formed with the body 130. In one embodiment, the stem 140 may be formed as a separate structure and coupled to the body 130 with a press-fit, snap-fit, or interference-fit engagement, or may be coupled to the body 130 using adhesives, bonding, welding, combinations thereof, or the like. Advantageously, the stem 140 being formed as a separate structure and coupled to the body 130 allows the stem 140 to be replaced with a stem of a different size or configuration to accommodate different catheters 90 without having to replace the entire port 100. This can reduce the amount of inventory required for transportation and storage and can reduce associated costs.

[0033] In one embodiment, the stem 140 may define a first stem lumen 142A and a second stem lumen 142B. In one embodiment, the port 100 may include a first stem 140A defining the first stem lumen 142A and a second stem 140B defining the second stem lumen 140B. In one embodiment, the stem 140 may engage the lumen 92 of the catheter 90, such as with an interference fit. In one embodiment, the outer surface of the stem 140 may include barbs 144, or similar structure, configured to engage the catheter 90 with an interference fit.

[0034] In one embodiment, the stems 140 may be configured to engage the dual lumen catheter 90. The first stem 140A engages the first catheter lumen to provide fluid communication between the distal reservoir 132A and the first catheter lumen, and the second stem 140B engages the second catheter lumen to provide fluid communication between the proximal reservoir 132B and the second catheter lumen.

[0035] 4A and 4B show further details of the septum 120 of the port 100. In one embodiment, the septum 120 may define a perimeter 124 configured to engage a rim 134 of the body 130, as described herein. As shown in FIG. 4A , the "footprint" or shape of the perimeter 124 when viewed in plan view may match the shape of the rim 134 of the body 130. For example, the shape of the footprint may represent two converging circles or a Cassini oval. However, it will be understood that footprints of other shapes are also contemplated.

[0036] In one embodiment, the septum 120 may include one or more upper portions 122 that may extend transversely axially upward to engage one or more septum openings 116 in the body 110. For example, the distal upper portion 122A may extend transversely axially upward to engage the distal septum opening 116A. The proximal upper portion 122B may extend transversely axially upward to engage the proximal septum opening 116B. In one embodiment, the septum 120 may include one or more lower portions 128 that may extend transversely axially downward to engage one or more reservoirs 132. For example, the distal lower portion 128A may extend transversely axially downward to engage the distal reservoir 132A. The proximal lower portion 128B may extend transversely axially downward to engage the proximal reservoir 132B. In one embodiment, the lower portions 128 may define a horizontal shape that matches the horizontal cross-sectional shape of the reservoirs 132. As shown, the shape of the lower portion may define a circle, although other shapes are contemplated. The diameter of the lower portion 128 may be equal to or slightly smaller than the diameter of the reservoir 132. Advantageously, the upper portion 122 and the lower portion 128 may cooperate to align the septum opening 116 with the reservoir 132 along the transverse axis.

[0037] In one embodiment, the septum 120 may include one or more palpation features 126 configured to facilitate positioning of the port 100 when placed subcutaneously. For example, the septum 120 may include a septum palpation feature 126. Similarly, the body 110 may include a body palpation feature 118, as described herein. In one embodiment, the one or more septum palpation features 126 may be disposed on one or more top portions 122 of the septum 120 and may extend through the septum opening 116 of the body 110. The palpation features 118, 126 may include one or more protrusions, symbols, alphanumeric symbols, shapes, etc. The one or more protrusions, symbols, alphanumeric symbols, shapes, etc. are configured to indicate one of the locations of the reservoirs 132 disposed beneath the palpation feature and / or distinguish one or more reservoirs 132, e.g., distal reservoir 132A and proximal reservoir 132B. In one embodiment, a portion of the upper portion 122 or a portion of the septum palpation feature 126 may extend horizontally outward from the transverse axis to engage the top surface of the body 110. Advantageously, the septum 120 may maintain engagement with the body 110.

[0038] 1B, distal upper portion 122A may include a groove 162 configured to receive needle guard 160 therein. For example, needle guard 160 may be coupled to housing 110 and may extend across a portion of distal septum opening 116A. When housing 110 is assembled with septum 120 and body 130, needle guard 160 may be received in groove 122 disposed in septum 120. In one embodiment, as shown in FIGS. 4A and 4B, septum 120 may include needle guard 160 formed therein and penetrating a portion of septum 120. For example, needle guard 160 may be formed from a material different from the material of septum 120 and may exhibit different mechanical properties. The needle guard 160 may be formed within the distal upper portion 122A and aligned with the conduit 150 located below the distal upper portion 122A. In one embodiment, the needle guard 160 may be formed from a rigid or needle-impermeable material, such as a resin, polymer, metal, alloy, composite, etc. The septum 120 may be formed from a compliant or needle-penetrable material, such as silicone rubber. In one embodiment, the needle guard 160 may be formed from the same material as the housing 110.

[0039] 6-8D show various details of one embodiment of a body 230 that can be used with the port 100. The body 230 may define a proximal reservoir 232B and a recess 236 configured to receive a reservoir insert 238 that defines a distal reservoir 232A. The body 230 may further include a conduit opening 254 through a wall of the body 230 extending between the proximal reservoir 232B and the distal reservoir recess 236. The conduit opening 254 may communicate between the proximal reservoir 232B and the recess 236. In one embodiment, the conduit opening 254 may communicate with a channel 256 disposed in the wall of the recess 236. The channel 256 may extend circumferentially from the conduit opening 254 across the recess 236 to a stem recess 270 at the distal end of the body 230, disposed opposite the conduit opening 254.

[0040] In one embodiment, the first reservoir insert 238A can define a distal reservoir 232A and a first stem lumen opening 246A that penetrates the wall of the first reservoir insert 238A. When the first reservoir insert 238A is disposed within the reservoir recess 236, the first stem lumen opening 246A can be aligned with the first stem lumen 142A to provide fluid communication between the distal reservoir 232A and the first stem lumen 142A. In one embodiment, the second stem lumen 242B can be in communication with the channel 256. In one embodiment, as shown in FIG. 7A , the outer surface of the first reservoir insert 238A can cooperate with the channel 256 to form a curved conduit lumen 252. A conduit lumen 252 extends around the distal reservoir 232A and provides fluid communication between the proximal reservoir 232B and the second stem lumen 142B.

[0041] In one embodiment, the recess 236 may also be configured to receive a second reservoir insert 238B instead of the first reservoir insert 238A. FIGS. 8A-8D show further details of the second reservoir insert 238B. The second reservoir insert 238B may define the distal reservoir 232A and may include a first stem lumen opening 246A. The first stem lumen opening 246A may be aligned with the first stem lumen 142A to provide fluid communication between the distal reservoir 232A and the first stem lumen 142A. In one embodiment, the second reservoir insert 238B may further include a straight conduit 150 that defines a lumen 152 and extends through the distal reservoir 232A.

[0042] 7B, when the second reservoir insert 238B is received within the recess 236, the straight conduit 150 may provide fluid communication between the proximal reservoir 232B and the second stem lumen 142B. Note that a portion of the conduit 150 may extend from the outer surface of the second reservoir insert 238B, blocking the channel 256 and preventing fluid communication therethrough.

[0043] Thus, the body 230 may be configured to form a curved conduit lumen 252 that extends circumferentially around the distal reservoir 232A. Alternatively, the first reservoir insert 238A may be replaced with a second reservoir insert 238B to form the line conduit 150 directly between the proximal reservoir 232B and the stem 140. Advantageously, the body 230 may be easily reconfigured during manufacturing or assembly with minimal changes to parts or assembly tooling. This can lead to increased efficiencies in inventory and manufacturing, improving associated costs.

[0044] Although some specific embodiments are disclosed herein, and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art. In broader aspects, these adaptations and / or modifications are also encompassed. Thus, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A vascular access port, comprising: a body including a stem extending longitudinally distally from the body and defining a first stem lumen and a second stem lumen; a distal reservoir disposed adjacent the port stem and in fluid communication with the first stem lumen; a proximal reservoir disposed adjacent to the distal reservoir and in fluid communication with a conduit extending through the distal reservoir, thereby providing fluid communication with the second stem lumen; a needle-pierceable septum disposed on at least the distal reservoir of the distal reservoir and the proximal reservoir; a needle guard extending over the distal reservoir and configured to prevent a needle accessing the distal reservoir from contacting the conduit; A vascular access port comprising:

2. The vascular access port of claim 1 , wherein the needle guard extends over a portion of the septum.

3. The vascular access port of claim 1 , wherein the needle guard penetrates a portion of the septum.

4. The vascular access port of claim 1 , wherein the needle guard extends below the septum and above the distal reservoir.

5. The vascular access port of claim 1 , wherein an axis of the conduit is aligned with an axis of the second stem lumen.

6. The vascular access port of claim 1 , wherein the proximal reservoir is located on an opposite side of the distal reservoir from the port stem.

7. The vascular access port of claim 1 , wherein the port stem, the distal reservoir, and the proximal reservoir are arranged along a linear axis.

8. 8. The vascular access port of claim 1, further comprising a housing disposed over one or both of the body and the septum and configured to secure the septum in a fixed position over one or both of the distal reservoir and the proximal reservoir.

9. The vascular access port of claim 8 , wherein the housing is formed from a compliant material and is overmolded onto the body.

10. The vascular access port of claim 8 , wherein the housing is formed from a rigid material and is secured to the body with an interference fit, press fit, or snap fit engagement.

11. 11. The vascular access port of claim 10, further comprising a base configured to engage the housing and secure one or both of the body and the septum between the base and the housing.

12. 12. The vascular access port of claim 8, wherein the housing includes one or more septum openings aligned along a transverse axis with one or both of the distal reservoir and the proximal reservoir, and a portion of the septum extends through the septum opening.

13. 13. The vascular access port of claim 1, wherein the body defines a recess configured to receive a reservoir insert, the reservoir insert defining the distal reservoir.

14. 1. A method of manufacturing a port, comprising: forming a body having a proximal reservoir, a distal reservoir, and a stem; penetrating the distal reservoir from the proximal reservoir to the stem to form a conduit providing fluid communication between the proximal reservoir and the stem; forming a needle guard extending over the conduit and configured to prevent a needle accessing the distal reservoir from striking the conduit; coupling a needle-pierceable septum disposed on at least the distal reservoir of the proximal and distal reservoirs to the body; coupling a housing to one or both of the body and the septum to secure the septum to the body; A method for providing

15. the housing defines a septum opening aligned with the distal reservoir along a transverse axis; The method of claim 14 , wherein the needle guard is coupled to the housing and extends across the septum opening.

16. 16. The method of claim 15, wherein the septum includes a groove extending longitudinally through a top surface of the septum, the groove configured to receive the needle guard.

17. 15. The method of claim 14, wherein the needle guard is integrally formed with and penetrates the septum.

18. 15. The method of claim 14, wherein the needle guard is coupled to the body and extends from a first edge of the distal reservoir to a second edge of the distal reservoir opposite the first edge.

19. forming a reservoir insert defining the distal reservoir; 19. The method of any one of claims 14 to 18, wherein the reservoir insert is configured to fit within a recess defined in the body, and the reservoir insert is configured to be removable and replaceable with a second reservoir insert.

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