Vascular Access Devices and Port Placement Systems

Abstract

The embodiments are directed to a low-profile insertable port system and associated methods of use. The port can define a port lumen extending between an inlet and an outlet and can include a needle-penetrable septum or valve structure. The port stem can be coupled to a lumen of the catheter and can optionally include a catheter lock. The diameter, cross-sectional area or shape of the port lumen can be substantially equal to the diameter, cross-sectional area or shape of the catheter lumen in a relaxed state. Additionally, the port lumen can define a straight axis and can be aligned with the axis of the catheter lumen. Thus, the port can reduce fluid flow resistance between the port and the catheter. The outer contour of the port can be substantially equal to the outer contour of the catheter. Thus, placing the port subcutaneously can require a smaller incision site and improve recovery time and aesthetics.

Description

Summary of the Invention

[0001] Briefly summarized, embodiments disclosed herein are directed to a low-profile insertable subcutaneous vascular access system and associated methods. The system includes a low-profile port that defines an outer contour substantially the same as the outer contour of a catheter coupled thereto. The low-profile port is subcutaneously positionable and requires a much smaller insertion site than a conventional port. Thus, fewer or no sutures are required to close the insertion site as well as the port is "insertable," improving patient recovery time, reducing scarring, and improving aesthetics. Additionally, the lumen of the port can define the same diameter or cross-sectional shape as the catheter lumen and can be aligned with the catheter lumen, creating little or no resistance to fluid flow through the lumen of the port. A placement tool configured to form an insertion site and place the port subcutaneously is also disclosed.

[0002] Disclosed herein is a vascular access device configured for subcutaneous placement, the vascular access device including a catheter defining a catheter lumen and providing fluid communication with a patient's vasculature, and a port including a body defining a port lumen extending along a longitudinal axis from an inlet to an outlet, the port lumen defining a uniform cross-sectional diameter between the inlet and the outlet.

[0003] In some embodiments, the port lumen defines a uniform cross-sectional area. In some embodiments, the port lumen defines a uniform cross-sectional shape. In some embodiments, the port lumen includes a valve or needle-penetrable septum configured to control fluid flow through the port lumen. In some embodiments, the outlet of the port is defined by a stem configured to be inserted into the lumen of the catheter. In some embodiments, a diameter of the port lumen is equal to a diameter of the lumen of the catheter in a relaxed state. In some embodiments, a cross-sectional area of ​​the port lumen is equal to a cross-sectional area of ​​the lumen of the catheter in a relaxed state.

[0004] In some embodiments, the cross-sectional shape of the port lumen is equal to the cross-sectional shape of the lumen of the catheter in a relaxed state. In some embodiments, the vascular access device further includes a nub extending proximally from a lower edge of the inlet, the nub configured to receive an access needle while impacting the access needle and direct the needle toward the inlet. In some embodiments, the nub includes a longitudinally extending sidewall extending perpendicularly from an edge of the nub, the sidewall configured to direct a needle impacting the sidewall toward the inlet. In some embodiments, an axis of a portion of the port lumen is aligned with an axis of the catheter lumen. In some embodiments, the portion of the port lumen extends between the septum and the outlet.

[0005] In some embodiments, an axis of a second portion of the port lumen extends at an angle relative to a first portion, and the second portion is disposed proximal to a septum. In some embodiments, an outer diameter of the port body is less than twice an outer diameter of the catheter. In some embodiments, an outer diameter of the port body is greater than between 170% and 130% of an outer diameter of the catheter. In some embodiments, the port body comprises an echogenic material or a radiopaque material. In some embodiments, the vascular access device further comprises an insertion tool, the insertion tool comprising a tool head having a sharp leading edge and configured to form a tissue pocket to receive the vascular access device. In some embodiments, the vascular access device further comprises a catheter lock configured to secure the catheter to the outlet.

[0006] Also disclosed is a port placement system configured to place a port subcutaneously, the port placement system including: a port defining a lumen extending along a longitudinal axis from an inlet to an outlet, the lumen defining a uniform cross-sectional diameter between the inlet and the outlet; a catheter coupled to a distal outlet and in fluid communication with the distal outlet; a placement tool including a housing defining a cavity configured to receive the port, the housing including an elongated opening extending longitudinally along a bottom surface of the housing and in communication with the cavity; a handle extending from the housing; and a nose portion hinged to the housing at an end opposite the handle and configured to transition between a closed position and an open position to release the port from the cavity.

[0007] In some embodiments, the nose defines a tapered outer contour. In some embodiments, the placement tool includes a sharp leading edge configured to form one of an incision site and a tissue pocket. In some embodiments, the port placement system further includes a blade disposed on the leading edge. In some embodiments, the port placement system further includes an actuation button disposed on the handle and configured to transition the nose between an open position and a closed position. In some embodiments, a lateral width of the elongated opening is less than a diameter of the port and greater than a diameter of the catheter.

[0008] In some embodiments, the handle defines a cavity and an elongated opening, the cavity of the handle communicating with the cavity of the housing and the elongated opening of the handle communicating with the elongated opening of the housing. In some embodiments, a lateral width of the opening of the handle is greater than a diameter of the port. In some embodiments, the lumen of the port defines a uniform cross-sectional area. In some embodiments, the lumen of the port defines a uniform cross-sectional shape. In some embodiments, the lumen of the port includes a valve or a needle-penetrable septum.

[0009] In some embodiments, the outlet of the port is defined by a stem configured to be inserted into the lumen of the catheter. In some embodiments, the port placement system further comprises a catheter lock configured to secure the catheter to the outlet. In some embodiments, the port further comprises a nub extending from a bottom edge of the inlet, the nub configured to receive an access needle while impacting the access needle and direct the needle towards the inlet. In some embodiments, the port comprises an echogenic or radiopaque material. In some embodiments, an axis of the lumen is aligned with an axis of the catheter.

[0010] Also disclosed is a method of placing a port having an associated catheter, the method including placing the port within a housing of an insertion tool, the tool including an elongated opening extending along a bottom surface of the housing and communicating with a cavity of the housing, biasing a leading edge of the tool subcutaneously, forming a tissue pocket to receive the port, transitioning a nose of the housing to an open position, retracting the insertion tool proximally, and disengaging the tool from the port and the catheter.

[0011] In some embodiments, the elongate opening in the housing defines a lateral width less than a diameter of the port and greater than a diameter of the catheter. In some embodiments, the method further includes a handle extending from the housing opposite the leading edge. In some embodiments, the handle defines a handle cavity in communication with the cavity in the housing. In some embodiments, the handle includes an elongate opening extending along a lower surface of the handle and in communication with the elongate opening in the housing. In some embodiments, the lateral width of the elongate opening in the handle is greater than a diameter of the port.

[0012] In some embodiments, the method further includes forming an incision site with the leading edge of the insertion tool. In some embodiments, the method further includes actuating an actuator disposed on the tool to transition the nose between an open position and a closed position. In some embodiments, disengaging the tool from the port and the catheter further includes sliding the catheter through the elongate opening in the housing.

[0013] A more particular description of the present disclosure will be made 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 should not be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0014] [Figure 1A] 1 illustrates a perspective view of a low profile insertable port according to an embodiment disclosed herein. [Figure 1B] 1 illustrates a side view of a low profile insertable port according to an embodiment disclosed herein. [Figure 1C] 1 illustrates a side view of a low profile insertable port including a nub according to an embodiment disclosed herein. [Figure 2A] 1 illustrates a perspective view of a low profile insertable port according to an embodiment disclosed herein. [Figure 2B] 1 illustrates a side view of a low profile insertable port according to an embodiment disclosed herein. [Figure 3A] 1 illustrates a perspective view of an insertion tool according to an embodiment disclosed herein. [Figure 3B] FIG. 3B shows an enlarged detailed view of the insertion tool of FIG. 3A as disclosed herein. [Figure 3C] 1 illustrates a top view of an insertion tool according to an embodiment disclosed herein. [Figure 3D]1 illustrates a side view of an insertion tool according to an embodiment disclosed herein. [Figure 4A] 1 shows a perspective view of a port placement system according to an embodiment disclosed herein. [Figure 4B] 4B shows an enlarged detailed view of the port placement system of FIG. 4A according to an embodiment disclosed herein. [Figure 4C] 1 illustrates a top view of a port placement system according to an embodiment disclosed herein. [Figure 4D] FIG. 1 illustrates a side view of a port placement system according to an embodiment disclosed herein. [Figure 4E] FIG. 2 illustrates a bottom view of a port placement system according to an embodiment disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] 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. It should also be understood that the specific embodiments disclosed herein can have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0016] With regard to the terms used herein, it should also be understood that the terms are intended to describe some particular embodiments, and that the 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 within a group of features or steps, and do not provide sequential or numerical limitations. 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 is not necessarily limited to three features or steps. Labels such as "left", "right", "upper", "lower", "front", "rear", etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one", "one", and "said" also include plural references unless the context clearly dictates otherwise.

[0017] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a needle includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, 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 otherwise suggested by context, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0018] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, the "distal end" of a needle includes the end of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Although a distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a catheter.

[0019] In the described embodiments, the longitudinal axis extends substantially parallel to the axial length of the catheter, as shown in Figure 1A, the lateral axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal and lateral axes.

[0020] 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-1C show a low-profile, insertable vascular access device or "port" 100 configured to be placed subcutaneously and accessed by a needle, cannula, or similar device to provide fluid communication with a patient's vasculature. FIG. 1A shows a perspective view of the port 100. FIGS. 1B-1C show side views of an embodiment of the port 100. The port 100 generally includes an axially extending port body 110 and a stem 120 extending from the port body 110 and configured to engage a catheter 90. As used herein, the port 100 may be disposed toward a proximal end of the port 100 / catheter 90 assembly, and the catheter may be disposed toward a distal end of the port 100 / catheter 90 assembly.

[0021] The catheter 90 may include a flexible elongate tube or body configured to engage the port stem 120 with an interference fit. The distal end of the catheter 90 may be disposed within the patient's vasculature to provide fluid communication with the vasculature. The proximal end of the catheter 90 may be configured to be stretched over the port stem 120 to provide a fluid-tight seal therebetween. In other words, the stem 120 may be configured to engage the lumen of the catheter 90. The catheter 90 may be elastically deformed to receive the port stem 120 therein. In a relaxed state, the catheter lumen 92 may define a diameter, a cross-sectional area, and a cross-sectional shape (e.g., circular, semicircular, elliptical, etc.). In one embodiment, the catheter lock 80 may engage an outer surface of the catheter 90 to further secure the catheter 90 to the port stem 120.

[0022] In one embodiment, the port 100 can define a lumen 140 extending from an inlet 122 disposed at a proximal end to an outlet 124 disposed at a distal end. In one embodiment, the outlet 124 can be defined by the port stem 120. In one embodiment, the inlet 122 can be defined as a proximal-most opening to the lumen 140 and can be configured to receive a needle therein. In one embodiment, the outlet 124 can be defined as a distal-most opening of the port lumen 140 and can provide fluid communication with the catheter lumen 92. In one embodiment, the port lumen 140 can define a substantially uniform diameter along its entire axial length, i.e., from the inlet 122 to the outlet 124. In one embodiment, the port lumen 140 can define a substantially uniform cross-sectional area along its entire axial length. In one embodiment, the port lumen 140 can define a substantially uniform cross-sectional shape along its entire axial length.

[0023] In one embodiment, the diameter of the port lumen 140 can be equal to the diameter of the catheter lumen 92. In one embodiment, the cross-sectional area of ​​the port lumen 140 can be equal to the cross-sectional area of ​​the catheter lumen 92. In one embodiment, the cross-sectional shape of the port lumen 140 can be equal to the cross-sectional shape of the catheter lumen 92. In one embodiment, the axis of the port lumen 140 extends parallel to or is aligned with the axis of the catheter lumen 92. In one embodiment, the port 100 can further include a needle-penetrable septum 130, valve, or similar structure configured to control the flow of fluid through the lumen 140.

[0024] Advantageously, the port lumen 140 can provide a direct fluid pathway with the catheter lumen 92 with little or no change in diameter, cross-sectional area, or cross-sectional shape to minimize any fluid resistance through the port lumen 140. Additionally, the axis of the port lumen 140 can be aligned with the axis of the catheter lumen 92 to minimize any fluid resistance through the port lumen 140. This can increase the flow rate through the port 100, through the catheter 90, and into the patient's vasculature.

[0025] In one embodiment, the outer diameter or outer contour of the port body 110 can be substantially the same as or slightly larger than the outer diameter or outer contour of the catheter 90. In one embodiment, the diameter (DP) of the port at its widest or highest point can be less than twice the diameter (DC) of the catheter. In other words, the maximum diameter (DP) of the port along an axis extending perpendicular to the longitudinal axis can be less than 200% of the diameter (DC) of the catheter along the same axis. In one embodiment, the diameter (DP) of the port can be 130% to 170% of the diameter (DC) of the catheter. Advantageously, the maximum dimension of the port 110 can be substantially the same as or slightly larger than the dimension of the catheter 90. Thus, placing the port 110 can require the same size incision site as would be required to place the catheter 90 alone. Advantageously, the incision site required to place the port may require fewer sutures to close or no sutures to close the site, improving patient recovery time, reducing scarring, and improving aesthetics.

[0026] 1B, a first portion of the port lumen 140A, for example disposed between the septum 130 and the outlet 124, can extend along an axis aligned with the axis of the catheter lumen 92. A second portion of the port lumen 140B, for example disposed proximal to the septum 130, can extend at an angle (θ) relative to the first portion of the port lumen 140A. The angle (θ) can be between 1° and 30°.

[0027] In one embodiment, as shown in FIG. 1C, the port body 110 can define a lumen 140 that extends straight along a longitudinal axis and is aligned with the axis of the catheter lumen 92. In one embodiment, the port body 110 can further include a nub 150 extending from a bottom edge of the inlet 122 and configured to receive the needle tip while impacting against it and direct the needle tip toward the inlet 122. The nub 150 can extend parallel to a bottom surface of the port body 110. In one embodiment, the nub 150 can define a substantially flat upper surface. In one embodiment, the nub 150 can define a concave upper surface. In one embodiment, the nub 150 can include a guide channel or groove configured to receive the needle tip and direct the needle tip toward the inlet 122. In one embodiment, the nub 150 can include one or more side walls 152 extending longitudinally from a side edge of the nub 150 and configured to guide the needle towards the inlet 122. The side walls 152 can prevent the needle tip from sliding laterally off the top surface of the nub 150.

[0028] In one embodiment, the underside of the port body 110 can define a substantially flat surface. In one embodiment, a portion of the port 110 can include an echogenic or radiopaque material configured to facilitate positioning and access of the port under medical imaging.

[0029] 2A-2B show an embodiment of a low profile insertable vascular access device or "port" 200. FIG. 2A shows a perspective view of the port 200. FIG. 2B shows a side view of the port 200. The port 200 generally includes an axially extending port body 210 and a stem 220 extending from the port body 210, the stem 220 defining a distal opening and configured to engage a catheter 90, as described herein. In one embodiment, a catheter lock 80 can engage an exterior surface of the catheter 90 to further secure the catheter 90 to the port stem 220, as described herein.

[0030] In one embodiment, the port 200 can define a lumen 240 extending from an inlet 222 disposed at the proximal end to an outlet 224 disposed at the distal end. In one embodiment, the outlet 224 can be defined by the port stem 220 of the port stem 220. In one embodiment, the port lumen 240 can define a substantially uniform diameter along its entire axial length, i.e., from the inlet 222 to the outlet 224. In one embodiment, the port lumen 240 can define a substantially uniform cross-sectional area along its entire axial length. In one embodiment, the port lumen 240 can define a substantially uniform cross-sectional shape along its entire axial length.

[0031] In one embodiment, the diameter of the port lumen 240 can be equal to the diameter of the catheter lumen 92. In one embodiment, the cross-sectional area of ​​the port lumen 240 can be equal to the cross-sectional area of ​​the catheter lumen 92. In one embodiment, the cross-sectional shape of the port lumen 240 can be equal to the cross-sectional shape of the catheter lumen 92. In one embodiment, the axis of the port lumen 240 extends parallel to or is aligned with the axis of the catheter lumen 92. In one embodiment, the port 200 can further include a needle-penetrable septum 230, valve, or similar structure configured to control the flow of fluid therethrough.

[0032] Advantageously, the port lumen 240 can define a straight path with little or no change in diameter, cross-sectional area, or cross-sectional shape to minimize any fluid resistance through the port lumen 240. Additionally, the port lumen 240 can match the catheter lumen 92 with little or no change in diameter, cross-sectional area, or cross-sectional shape to minimize any fluid resistance between the port 200 and the catheter 90.

[0033] In one embodiment, the outer diameter or contour of the port body 210 can be the same as or slightly larger than the outer diameter or contour of the catheter 90. In one embodiment, the diameter (DP) of the port at its widest or highest point can be less than twice the diameter (DC) of the catheter. In other words, the maximum diameter (DP) of the port along an axis extending perpendicular to the longitudinal axis can be less than 200% of the diameter (DC) of the catheter along the same axis. In one embodiment, the diameter (DP) of the port can be 130% to 170% of the diameter (DC) of the catheter. Advantageously, the maximum dimension of the port 210 can be substantially the same as or slightly larger than the dimension of the catheter 90. Thus, placing the port 210 can require the same size incision site as would be required to place the catheter 90 alone. Advantageously, the incision site required to place the port 200 can be significantly smaller than a conventional port and can require fewer or no sutures to close the site. This results in improved recovery time, reduced scarring, and improved aesthetics for the patient.

[0034] In one embodiment, the port 210 can include a nub 250 extending proximally therefrom, i.e., extending from the stem away from the inlet 222 at the opposite end of the port 200. The nub 250 can extend parallel to a bottom surface of the port body 210 and can be configured to guide the needle towards the inlet 222. Optionally, the nub 250 can include one or more side walls 252 that are angled and configured to guide the needle towards the septum 230. In one embodiment, the nub 250 includes a longitudinally extending guide channel 254 configured to receive the needle tip therein and guide the needle tip towards the inlet 222. In one embodiment, a portion of the port 210 can include an echogenic or radiopaque material configured to facilitate location and access of the port under medical imaging.

[0035] 3A-3D show an embodiment of a placement tool 300 configured to form a tissue pocket for receiving a low profile insertable port 100, 200 as described herein. The tool 300 may generally include a tool head 310 disposed at a forward end and a handle 320 extending rearwardly from the head 310. The handle 320 may be configured to be grasped by a clinician to manipulate the head 310 to form a tissue pocket.

[0036] In one embodiment, the head 310 can define a tapered shape extending longitudinally along one of a horizontal or vertical plane. In one embodiment, the nub 310 can define a spade-like shape. In one embodiment, the head 310 can define an outer shape similar to that of the nub 150, 250 and / or port body 110, 210 of the port 100, 200. Thus, when the head 310 is urged subcutaneously, the head 310 can define a tissue pocket that matches the shape or outer contour of the port 100, 200 to minimize subcutaneous migration.

[0037] In one embodiment, the head 310 can define a substantially flat lower surface 312 and a sloped front surface 314, each extending rearwardly from a leading edge 330. As shown in FIGURE 3B, the sloped front surface 314 can extend at a first angle relative to the flat lower surface. In one embodiment, the head 310 can include an upper surface 316 extending from a rearmost end of the front surface 314, the upper surface 316 extending at a second angle relative to the lower surface 312 that is different from the first angle.

[0038] In one embodiment, the head 310 can include a sharp leading edge 330 configured to separate subcutaneous tissue to form a tissue pocket when the head 310 is urged forwardly under the skin. In one embodiment, the leading edge 330 can be configured to form an insertion site. In one embodiment, the leading edge 330 can be formed from a material different than the material of the head 310 and can include a blade or similar structure configured to form an insertion site and / or separate subcutaneous tissue to form a tissue pocket. In one embodiment, the maximum transverse or lateral diameter (DH) of the head 310 can be the same as or slightly larger than the maximum transverse or lateral diameter (DP) of the port 100, 200.

[0039] 4A-4E illustrate one embodiment of a port placement system 400. The system 400 may generally include a placement tool 402 configured to receive a low profile insertable port, such as port 100 or port 200, therein and place the port 100, 200 subcutaneously. The tool 402 may generally include a housing 410 and a handle 420 extending rearwardly from the housing 410. The housing 410 may include an angled or sharpened leading edge 430 configured to separate subcutaneous tissue to form a tissue pocket. The housing 410 may define a cavity 412 therein configured to receive the port 100, 200. The housing 410 may further include an elongated opening 414 extending along a lower surface of the housing 410 and in communication with the cavity 412. In one embodiment, the elongated opening 414 can define a width (w) that is less than the outermost diameter (DP) of the port 100, 200 and can be greater than or substantially the same as the diameter (DC) of the catheter 90.

[0040] In one embodiment, the handle 420 can define a handle cavity 422 in communication with the cavity 412 of the housing 410. The handle 420 can include an elongated opening 424 extending along a bottom surface and in communication with the handle cavity 422. The handle opening 424 can be axially aligned and / or in communication with the elongated opening 414 of the housing 410. The handle opening 424 can define a lateral width greater than a maximum outer diameter (DP) of the ports 100, 200. Thus, the handle opening 424 allows a clinician to load and retain the port 100, 200 and catheter 90 assembly in the housing cavity 422 by passing the ports 100, 200 through the handle opening 424 and into the handle cavity 412 while advancing the ports 100, 200 forward into the cavity 412 of the housing 410.

[0041] In one embodiment, the housing 410 can include a nose 440 hinged to the housing 410 and transitionable between a closed position and an open position. In one embodiment, the nose 440 can define a leading edge 430. In one embodiment, a portion of the housing 410 can define the leading edge 430. In one embodiment, the nose 440 in the closed position can cooperate with a portion of the housing 410 to define the leading edge 430. The nose 440 in the closed position (FIGS. 4A, 4C-4E) can define an angled, tapered, spade-shaped, or chamfered profile extending rearwardly from the leading edge 430. The nose 440 can be configured to separate subcutaneous tissue to form a tissue pocket when the tool 402 is urged subcutaneously as described herein. In one embodiment, the leading edge 430 can include a blade or similar structure configured to form an incision site and / or separate subcutaneous tissue to form a tissue pocket. In one embodiment, the contour of the nose 440 can substantially match the outer contour of the port 100, 200. This can provide a tissue pocket that matches the outer contour of the port 100, 200 and can minimize subcutaneous migration. In one embodiment, the nose 440 can pivot to an open position (FIG. 4B) to provide communication with the interior cavity 412 of the housing 410 and allow the port 100, 200 to slide distally and be positioned within the tissue pocket.

[0042] In one embodiment, the handle 420 can include an actuator 450 operatively coupled to the nose portion 440 and configured to transition the nose portion between the open and closed positions. In one embodiment, the actuator 450 can be a push button and can include one or more gears, levers, biasing members, or similar mechanisms configured to transition the nose portion 440 between the open and closed positions when the push button is actuated. It will be understood that the push button is exemplary and that a variety of sliders, dials, thumb wheels, levers, or similar actuators are contemplated.

[0043] In an exemplary method of use, a port placement system 400 is provided that generally includes a tool 402 and a port, e.g., ports 100, 200, as described herein. In one embodiment, the ports 100, 200 may be loaded into the tool 402 by a clinician. In one embodiment, the ports 100, 200 may be loaded into the tool 402 by a clinician. The clinician can load the ports 100, 200 into the tool 402 by passing the ports 100, 200 through the handle opening 424 and into the handle cavity 422. The lateral width of the handle opening 424 can be wider than the outer diameter (DP) of the ports 100, 200 and catheter 90 assembly to allow the ports 100, 200 and catheter 90 assembly to pass through the handle opening 424. The longitudinal axis of the ports 100, 200 and catheter 90 assembly can be laterally aligned with the central axis 70 of the tool 420. The clinician may advance the ports 100, 200 forward along the central axis 70 until the ports 100, 200 are seated within the housing 410 and retained therein.

[0044] In one embodiment, one of the housing cavity 412 or the handle cavity 422 may include one or more tabs, detents, or abutments configured to allow the ports 100, 200 to be advanced into the housing cavity 412, but may abut one of the ports 100, 200 or the catheter 90 to mitigate retrograde migration of the ports 100, 200 from the housing cavity 412. With the ports 100, 200 disposed within the housing cavity 412, the catheter 90 may extend rearwardly through the handle cavity opening 424. A clinician may grasp the handle 420 to manipulate the housing 410 with the ports 100, 200 disposed therein. Optionally, a clinician may grasp the handle 420 and the catheter 90 together to manipulate the housing 410 and mitigate retrograde migration of the ports 100, 200 from the housing cavity 412.

[0045] The clinician can then urge the leading edge 430 subcutaneously. Optionally, the clinician can form an incision site on the skin surface for the housing 410 to pass through before urging the leading edge 430 subcutaneously. In one embodiment, the leading edge 430 of the tool can be sharp or can include a blade or similar structure configured to form an incision site when the housing 410 is urged subcutaneously. In one embodiment, the blade can be formed from a different material having different mechanical properties than the material of the housing 410. When the leading edge 430 is urged subcutaneously, the shape of the nose 440 can be configured to separate the subcutaneous tissue and form a tissue pocket.

[0046] Once the tissue pocket is formed, the clinician can actuate the actuator 450 to transition the nose 440 from a closed position to an open position. With the nose 440 in the open position, the ports 100, 200 disposed within the housing cavity 412 can be advanced forward of the tool 402 and disposed within the tissue pocket. In one embodiment, the clinician can manipulate the catheter 90 to advance the ports 100, 200 forward out of the housing cavity 412, and then the tool 402 can be withdrawn proximally. In one embodiment, with the nose 440 in the open position, the ports 100, 200 can be held stationary within the tissue pocket, optionally by the clinician manipulating the catheter 90. The tool 402 can then be withdrawn proximally from the tissue pocket, leaving the ports 100, 200 in place. In one embodiment, as the tool 402 is withdrawn proximally, the catheter 90 can pass axially through the handle cavity opening 424 and the housing cavity opening 414 located along the underside until the tool 402 disengages from the assembly of the ports 100, 200 and the catheter 90.

[0047] Although some specific embodiments have been disclosed herein, and those specific embodiments have been disclosed in some detail, those specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may become apparent to those skilled in the art, and are likewise encompassed in the broader aspects. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. 1. A vascular access device configured for subcutaneous placement, comprising: a catheter defining a lumen and providing fluid communication with the patient's vasculature; a port including a body defining a lumen extending along a longitudinal axis from an inlet to an outlet; wherein the lumen of the port defines a uniform cross-sectional diameter between the inlet and the outlet and includes a valve or needle-penetrable septum configured to control fluid flow through the lumen of the port.

2. The vascular access device of claim 1 , wherein the lumen of the port defines a uniform cross-sectional area.

3. The vascular access device of claim 1 or 2, wherein the lumen of the port defines a uniform cross-sectional shape.

4. The vascular access device of claim 1 , wherein the outlet of the port is defined by a stem configured to be inserted into a lumen of the catheter.

5. 5. The vascular access device of claim 1, wherein the diameter of the lumen of the port is equal to the diameter of the lumen of the catheter in an unstretched or undeformed state.

6. 6. The vascular access device of claim 1, wherein a cross-sectional area of ​​the lumen of the port is equal to a cross-sectional area of ​​the lumen of the catheter in an unstretched or undeformed state.

7. 7. The vascular access device of claim 1, wherein the cross-sectional shape of the lumen of the port is equal to the cross-sectional shape of the lumen of the catheter in an unstretched or undeformed state.

8. 8. The vascular access device of claim 1, further comprising a nub extending proximally from a lower edge of the inlet, the nub configured to receive the access needle while impacting against the access needle and to direct the access needle toward the inlet.

9. 9. The vascular access device of claim 8, wherein the nub includes a longitudinally extending sidewall extending perpendicularly from an edge of the nub, the sidewall configured to direct the access needle striking the sidewall toward the inlet.

10. The vascular access device of claim 1 , wherein an axis of a first portion of the port lumen is aligned with an axis of the catheter lumen.

11. 10. The vascular access device of claim 1, wherein an axis of a first portion of the port lumen is aligned with an axis of the catheter lumen, the first portion extending between the valve or needle-penetrable septum and the outlet.

12. 12. The vascular access device of claim 11, wherein an axis of a second portion of the port lumen extends at an angle relative to the first portion, the second portion being disposed proximal to the valve or needle-penetrable septum.

13. 13. The vascular access device of claim 1, wherein a maximum outer diameter of the body of the port is less than twice the outer diameter of the catheter.

14. 14. The vascular access device of any one of claims 1-13, wherein a maximum outer diameter of the body of the port is greater than between 170% and 130% of an outer diameter of the catheter.

15. The vascular access device of claim 1 , wherein the body of the port comprises an echogenic or radiopaque material.

16. The vascular access device of any one of claims 1 to 15, further comprising an insertion tool, the insertion tool including a tool head having a sharp leading edge and configured to form a tissue pocket to receive the vascular access device.

17. 17. The vascular access device of claim 1, further comprising a catheter lock configured to secure the catheter to the outlet.

18. 1. A port placement system configured to subcutaneously place a port, comprising: a port defining a lumen extending along a longitudinal axis from an inlet to an outlet, the lumen defining a uniform cross-sectional diameter between the inlet and the outlet; a catheter coupled to and in fluid communication with an outlet of the port; 1. A placement tool comprising: a housing defining a cavity configured to receive the port therein, the housing including an elongated opening extending longitudinally along a bottom surface of the housing and in communication with the cavity; a handle extending from the housing; a nose portion hinged to the housing at an end opposite the handle and configured to transition between a closed position and an open position to release the port from the cavity; and placement tools including A port placement system comprising:

19. The port placement system of claim 18 , wherein the nose portion defines a tapered outer contour.

20. 20. The port placement system of claim 18 or 19, wherein the placement tool includes a sharpened leading edge configured to form one of an incision site and a tissue pocket.

21. 21. The port placement system of claim 20, further comprising a blade disposed on the leading edge.

22. 22. The port placement system of any one of claims 18 to 21, further comprising an actuation button disposed on the handle and configured to transition the nose portion between an open position and a closed position.

23. 23. The port placement system of claim 18, wherein a lateral width of the elongated opening is smaller than a diameter of the port and larger than a diameter of the catheter.

24. 24. The port placement system of any one of claims 18 to 23, wherein the handle defines a cavity and an elongated opening, the cavity of the handle communicating with the cavity of the housing and the elongated opening of the handle communicating with the elongated opening of the housing.

25. 25. The port placement system of claim 24, wherein a lateral width of the elongated opening in the handle is greater than a diameter of the port.

26. 26. The port placement system of any one of claims 18 to 25, wherein the lumen of the port defines a uniform cross-sectional area.

27. 27. The port placement system of any one of claims 18-26, wherein the lumen of the port defines a uniform cross-sectional shape.

28. 28. The port placement system of claim 18, wherein the lumen of the port includes a valve or a needle-penetrable septum.

29. 29. The port placement system of any one of claims 18 to 28, wherein the port outlet is defined by a stem configured to be inserted into a lumen of the catheter.

30. 30. The port placement system of any one of claims 18-29, further comprising a catheter lock configured to secure the catheter to the port.

31. 31. The port placement system of claim 18, wherein the port further includes a nub extending from a bottom edge of the inlet, the nub configured to receive the access needle while impacting against the access needle and to direct the access needle toward the inlet.

32. 32. The port placement system of any one of claims 18-31, wherein the port comprises an echogenic or radiopaque material.

33. 30. The port placement system of claim 29, wherein the axis of the port lumen is aligned with the axis of the catheter lumen.

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