Vascular access device and port indwelling system

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, the embodiments disclosed herein are directed to a thin, insertable subcutaneous vascular access system and related methods. The system includes a thin port that defines an outer profile that is substantially the same as the outer profile of a catheter coupled thereto. The thin port is deployable subcutaneously and requires a much smaller insertion site than conventional ports. Thus, fewer or no sutures are required to close the insertion site as well as the insertion site, the port is "insertable", the patient's recovery time is improved, scarring is reduced, and aesthetics are improved. Further, the lumen of the port can define the same diameter or cross-sectional shape as the diameter or cross-sectional shape of the catheter lumen, can be aligned with the catheter lumen, and creates little or no resistance to fluid flow through the lumen of the port. An implant tool configured to form an insertion site and deploy the port subcutaneously is also disclosed.

[0002] Disclosed herein is a vascular access device configured to be deployed subcutaneously, comprising a catheter defining a catheter lumen and providing fluid communication with a patient's vasculature, and a port comprising 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. WallIt includes. 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 diameter of the port lumen is equal to the diameter of the lumen of the catheter in a relaxed state. In some embodiments, the cross-sectional area of the port lumen is equal to the 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 barb extending proximally from the lower edge of the inlet, the barb being configured to receive the access needle while colliding with the access needle and direct the needle toward the inlet. In some embodiments, the barb includes side walls that extend orthogonally from the edge of the barb and extend longitudinally, and the side walls are configured to direct a needle that collides with the side walls toward the inlet. In some embodiments, the axis of a portion of the port lumen is aligned with the 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, the axis of the second portion of the port lumen extends at an angle with respect to the first portion, and the second portion is disposed proximal to the septum. In some embodiments, the outer diameter of the port body is less than twice the outer diameter of the catheter. In some embodiments, the outer diameter of the port body is greater than the outer diameter of the catheter between 170% and 130%. In some embodiments, the port body includes a sonicating material or a radiopaque material. In some embodiments, the vascular access device further includes an insertion tool, the insertion tool including a tool head having a sharp leading edge and configured to form a tissue pocket for receiving the vascular access device. In some embodiments, the vascular access device further includes a catheter lock configured to fix the catheter to the outlet.

[0006] Also disclosed is a port indwelling system configured to indwell a port subcutaneously, the port indwelling 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 the distal outlet and in fluid communication with the distal outlet; an indwelling tool including a housing defining a cavity configured to receive the port, the housing including an elongate opening extending longitudinally along a bottom surface of the housing and communicating with the cavity; a handle extending from the housing; and an arranging tool including a nose portion hinge-coupled to the housing at an end opposite to the handle and configured to move between a closed position and an open position to release the port from the cavity.

[0007] In some embodiments, the nose portion defines a tapered outer contour. In some embodiments, the indwelling tool includes a sharp leading edge configured to form one of an incision site and a tissue pocket. In some embodiments, the port indwelling system further includes a blade disposed on the leading edge. In some embodiments, the port indwelling system further includes a drive button disposed on the handle and configured to move the nose portion between an open position and a closed position. In some embodiments, a width of the elongate opening is smaller than a diameter of the port and larger than a diameter of the catheter.

[0008] In some embodiments, the handle defines a cavity and an elongate opening, the cavity of the handle communicating with the cavity of the housing, and the elongate opening of the handle communicating with the elongate opening of the housing. In some embodiments, a width of the opening of the handle is larger 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 septum penetrable by a needle. Wall including.

[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 retention system further includes a catheter lock configured to secure the catheter to the Port same. In some embodiments, the port further includes a nub extending from the bottom edge of the inlet, the nub being configured to receive the access needle while striking the access needle and direct the needle toward the inlet. In some embodiments, the port includes a sonicating material or a radiopaque material. In some embodiments, the axis of the lumen is aligned with the axis of the catheter.

[0010] Also disclosed is a method of retaining a port to which a catheter is attached, the method including placing the port within a housing of an insertion tool, the tool including an elongate opening extending along a bottom surface of the housing and in communication with a cavity of the housing, biasing a leading edge of the tool subcutaneously, forming a tissue pocket for receiving the port, moving a nose portion 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 of the housing defines a width that is smaller than a diameter of the port and larger than a diameter of the catheter. In some embodiments, the method further includes a handle extending from the housing on an opposite side of the leading edge. In some embodiments, the handle defines a handle cavity in communication with the cavity of the housing. In some embodiments, the handle includes an elongate opening extending along a bottom surface of the handle and in communication with the elongate opening of the housing. In some embodiments, a width of the elongate opening of the handle is larger than a diameter of the port.

[0012] In some embodiments, the method further includes forming an incision site using the leading edge of the insertion tool. In some embodiments, the method further includes driving an actuator disposed on the tool to move the nose portion 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 of the housing.

[0013] A more specific description of the present disclosure is made by referring to the specific embodiments shown in the accompanying drawings. It should be understood that these drawings show only typical embodiments of the invention and should not be considered as limiting its scope. Exemplary embodiments of the invention are described and explained with additional specificity and detail by using the accompanying drawings.

Brief Description of the Drawings

[0014]

Figure 1A

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Figure 1C

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Figure 4E

DETAILED DESCRIPTION OF THE INVENTION

[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 be readily separated from the specific embodiments and can optionally have features that can be combined with or substituted for the features of any of the many other embodiments disclosed herein.

[0016] Regarding the terms used in this specification, it should also be understood that the terms are for the purpose of describing some specific embodiments and 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 multiple features or multiple steps and do not provide sequential limitations or numerical restrictions. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps does not necessarily have to be limited to three features or steps. Labels such as "left", "right", "up", "down", "front", "rear", etc. are used for convenience and do not, for example, mean a specific fixed position, orientation, or direction. Instead, such notations are used, for example, to reflect relative positions, orientations, or directions. The singular forms "a", "one", and "the" include plural references unless the context clearly dictates otherwise.

[0017] Regarding "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 does not necessarily have to include the proximal end of the catheter. That is, unless otherwise suggested by the context, the proximal portion, proximal end portion, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0018] Regarding "distal", for example, the "distal portion" or "distal end portion" of a catheter as disclosed in this specification includes the portion of the catheter that is intended to be near or within the patient when the catheter is used in a patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be near or within the patient when the catheter is used in a patient. For example, the "distal end" of a needle includes the end of the catheter that is intended to be near or within the patient when the catheter is used in a patient. The distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, but the distal portion, distal end portion, or distal length of a catheter does not necessarily have to include the distal end of the catheter. That is, except where suggested by the context, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0019] In the description of the embodiments, as shown in FIG. 1A, the longitudinal axis extends substantially parallel to the axial length of the catheter. The transverse axis extends perpendicular to the longitudinal axis, and the transverse sectional axis extends perpendicular to both the longitudinal axis and the transverse axis.

[0020] Unless otherwise defined, all scientific and technical terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art. Figures 1A through 1C show a thin, insertable vascular access device, i.e., a "port" 100, configured to be implanted subcutaneously to provide fluid communication with a patient's vasculature and configured to be accessed by a needle, cannula, or similar device. Figure 1A shows a perspective view of port 100. Figures 1B through 1C show side views of an embodiment of port 100. Port 100 generally includes an axially extending port body 110 and a stem 120 extending from port body 110 and configured to engage catheter 90. As used herein, port 100 can be positioned toward the proximal end of the port 100 / catheter 90 assembly, and the catheter can be positioned toward the distal end of the port 100 / catheter 90 assembly.

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

[0022] In one embodiment, port 100 can define a lumen 140 that extends from an inlet 122 disposed at the proximal end to an outlet 124 disposed at the 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 the most proximal opening into the lumen 140 and can be configured to receive a needle therein. In one embodiment, the outlet 124 can be defined as the most distal 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, port 100 further includes a needle-penetrable septum Wall 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 path 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. Further, 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. Thereby, the flow rate into the patient's vasculature through the port 100 and through the catheter 90 can be increased.

[0025] In one embodiment, the outer diameter or outer profile of the port body 110 can be substantially the same as or slightly larger than the outer diameter or outer profile of the catheter 90. In one embodiment, the diameter (DP) of the port at its widest or tallest 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 between 130% and 170% of the diameter (DC) of the catheter. Advantageously, the maximum dimension of the port 110 can be substantially the same as the dimension of the catheter 90 or slightly larger than the dimension of the catheter 90. Thus, placing the port 110 may require an incision site of the same size 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 the patient's recovery time, reducing scarring, and improving aesthetics.

[0026] In one embodiment, as shown in FIG. 1B, for example, the first portion of the port lumen 140A disposed between the septum 130 and the outlet 124 can extend along an axis that aligns with the axis of the catheter lumen 92. For example, the second portion of the port lumen 140B disposed proximal to the septum 130 can extend at an angle (θ) with respect 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 extend straight along the longitudinal axis and define a lumen 140 that 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 the bottom edge of the inlet 122, configured to receive the needle tip while colliding with the needle tip and direct the needle tip toward the inlet 122. The nub 150 can extend parallel to the 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 that extend longitudinally from the side edges of the nub 150 and are configured to guide the needle toward the inlet 122. The side walls 152 can prevent the needle tip from sliding laterally and disengaging from the upper surface of the nub 150.

[0028] In one embodiment, the lower surface of the port body 110 can define a substantially flat surface. In one embodiment, a portion of the port 110 can include an acoustic generating material or a radiation-impermeable material configured to facilitate positioning and access to the port under medical imaging.

[0029] Figures 2A through 2B illustrate an embodiment of a thin, insertable vascular access device, or "port" 200. Figure 2A shows a perspective view of port 200. Figure 2B shows a side view of port 200. 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. In one embodiment, as described herein, a catheter lock 80 can engage the outer surface of catheter 90 and further secure catheter 90 to port stem 220.

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

[0031] In one embodiment, the diameter of port lumen 240 can be equal to the diameter of catheter lumen 92. In one embodiment, the cross-sectional area of port lumen 240 can be equal to the cross-sectional area of catheter lumen 92. In one embodiment, the cross-sectional shape of port lumen 240 can be equal to the cross-sectional shape of catheter lumen 92. In one embodiment, the axis of port lumen 240 extends parallel to or is aligned with the axis of catheter lumen 92. In one embodiment, 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 linear 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. Further, the port lumen 240 can be matched with little or no change in the diameter, cross-sectional area, or cross-sectional shape of the catheter lumen 92 to minimize any fluid resistance between the port 200 and the catheter 90.

[0033] In one embodiment, the outer diameter or outer profile of the port body 210 can be the same as or slightly larger than the outer diameter or outer profile of the catheter 90. In one embodiment, the diameter (DP) of the port at its widest or tallest 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 between 130% and 170% of the diameter (DC) of the catheter. Advantageously, the maximum dimension of the port 210 may be substantially the same as the dimension of the catheter 90 or slightly larger than the dimension of the catheter 90. Thus, placing the port 210 may require an incision site of the same size 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 may require fewer sutures or no sutures to close the site. This will improve the patient's recovery time, reduce scarring, and improve aesthetics.

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

[0035] Figures 3A through 3D illustrate an embodiment of an implant tool 300 configured to form a tissue pocket for receiving the thin, insertable ports 100, 200 as described herein. The tool 300 can generally include a tool head 310 disposed at the front end and a handle 320 extending rearwardly from the head 310. The handle 320 can be configured to be grasped by a clinician to operate the head 310 to form the tissue pocket.

[0036] In one embodiment, the head 310 can define a tapered shape that extends longitudinally along one of a horizontal plane or a 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 the outer shape of the nubs 150, 250 and / or the port bodies 110, 210 of the ports 100, 200. Thus, when the head 310 is biased subcutaneously, the head 310 can define a tissue pocket that conforms to the shape or outer profile of the ports 100, 200 to minimize subcutaneous movement.

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

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

[0039] Figures 4A through 4E illustrate one embodiment of a port placement system 400. The system 400 can generally include an implant tool 402 configured to receive a thin, insertable port, such as port 100 or port 200 therein and to subcutaneously implant ports 100, 200. The tool 402 can generally include a housing 410 and a handle 420 extending rearwardly from the housing 410. The housing 410 can include an angled or sharp leading edge 430 configured to separate subcutaneous tissue to form a tissue pocket. The housing 410 can define a cavity 412 configured to receive ports 100, 200 therein. The housing 410 can further include an elongate opening 414 extending along a lower surface of the housing 410 and in communication with the cavity 412. In one embodiment, the elongate opening 414 can define a width (w) that is less than the outermost diameter (DP) of ports 100, 200 and can be greater than or substantially the same as the diameter (DC) of 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 elongate 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 elongate opening 414 of the housing 410. The handle opening 424 can define a lateral width that is greater than the outermost diameter (DP) of ports 100, 200. Thus, the handle opening 424 allows a clinician to load and hold ports 100, 200 and catheter 90 assembly within the housing cavity 422 by passing ports 100, 200 through the handle opening 424 and into the handle cavity 412 and advancing ports 100, 200 forwardly into the cavity 412 of the housing 410.

[0041] In one embodiment, the housing 410 can include a nose portion 440 that is hingedly coupled to the housing 410 and is movable between a closed position and an open position. In one embodiment, the nose portion 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 portion 440 in the closed position can cooperate with a portion of the housing 410 to define the leading edge 430. The nose portion 440 in the closed position (FIGS. 4A, 4C-4E) can define an angled, tapered, spade-shaped, or chamfered contour that extends rearwardly from the leading edge 430. The nose portion 440 can be configured to separate subcutaneous tissue to form a tissue pocket when the tool 402 is biased 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 portion 440 can substantially match the outer contour of the ports 100, 200. Thereby, a tissue pocket that matches the outer contour of the ports 100, 200 can be provided, and subcutaneous movement can be minimized. In one embodiment, the nose portion 440 pivots to an open position (FIG. 4B) to provide communication with the internal cavity 412 of the housing 410, and the ports 100, 200 slide distally and can be disposed within the tissue pocket.

[0042] In one embodiment, the handle 420 can include an actuator 450 that is operatively coupled to the nose portion 440 and is configured to move the nose portion between an open position and a closed position. 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 move the nose portion 440 between the open position and the closed position when the push button is actuated. The push button is exemplary, and it will be understood that various sliders, dials, thumb wheels, levers, or similar actuators are contemplated.

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

[0044] In one embodiment, one or more claws, detents, or abutments configured to allow ports 100, 200 to advance into housing cavity 412 can be included in either housing cavity 412 or handle cavity 422, but can abut against either ports 100, 200 or catheter 90 to reduce retrograde movement of ports 100, 200 from housing cavity 412. With ports 100, 200 disposed within housing cavity 412, catheter 90 can extend rearwardly through handle cavity opening 424. The clinician can grip handle 420 to manipulate housing 410 with ports 100, 200 disposed therein. Optionally, the clinician can grip handle 420 and catheter 90 together to manipulate housing 410 and to reduce retrograde movement of ports 100, 200 from housing cavity 412.

[0045] Next, the clinician can 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 may be sharp or may 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 mechanical properties different from those of the material of the housing 410. When the leading edge portion 430 is urged subcutaneously, the shape of the nose portion 440 can be configured to separate the subcutaneous tissue and form a tissue pocket.

[0046] Once the tissue pocket is formed, the clinician can operate the actuator 450 to move the nose portion 440 from the closed position to the open position. With the nose portion 440 in the open position, the ports 100, 200 disposed within the housing cavity 412 can advance forward of the tool 402 and be disposed within the tissue pocket. In one embodiment, the clinician can operate the catheter 90 to advance the ports 100, 200 forward from the housing cavity 412, and then the tool 402 can be withdrawn in the proximal direction. In one embodiment, with the nose portion 440 in the open position, the ports 100, 200 can optionally remain stationary within the tissue pocket by the clinician operating the catheter 90. Then, the tool 402 can be withdrawn in the proximal direction from the tissue pocket leaving the ports 100, 200 in place. In one embodiment, when the tool 402 is withdrawn in the proximal direction, the catheter 90 can axially pass through the handle cavity opening 424 and the housing cavity opening 414 disposed along the lower surface until the tool 402 is disengaged from the assembly of the ports 100, 200 and the catheter 90.

[0047] Some specific embodiments are disclosed herein, and those specific embodiments are disclosed to some extent in detail, but those specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may be apparent to those skilled in the art, and in a broader aspect, these adaptations and / or modifications are similarly included. Therefore, developments from the specific embodiments disclosed herein can be carried out without departing from the scope of the concepts provided herein.

Claims

1. A vascular access device configured to be implanted subcutaneously, comprising: a catheter defining a lumen and providing fluid communication with a patient's vasculature; and 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 a needle-penetrable septum configured to control fluid flow through the lumen of the port.

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

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

4. The vascular access device according to any one of claims 1 to 3, wherein the outlet of the port is defined by a stem configured to be inserted into the lumen of the catheter.

5. The vascular access device according to any one of claims 1 to 4, wherein the diameter of the lumen of the port is equal to the diameter of the lumen of the catheter in an unextended or undeformed state.

6. The vascular access device according to any one of claims 1 to 5, wherein the cross-sectional area of the lumen of the port is equal to the cross-sectional area of the lumen of the catheter in an unextended or undeformed state.

7. The vascular access device according to any one of claims 1 to 6, 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 unextended or undeformed state.

8. The vascular access device according to any one of claims 1 to 7, further comprising a tab extending proximally from a lower edge of the inlet, the tab being configured to receive an access needle while colliding with the access needle and direct the access needle toward the inlet.

9. The vascular access device according to claim 8, wherein the tab includes side walls extending orthogonally from an edge of the tab and extending longitudinally, the side walls being configured to direct the access needle colliding with the side walls toward the inlet.

10. The vascular access device according to any one of claims 1 to 9, wherein an axis of a first portion of the lumen of the port is aligned with an axis of the lumen of the catheter.

11. The axis of the first portion of the lumen of the port is aligned with the axis of the lumen of the catheter, and the first portion extends between the valve or needle-penetrable septum and the outlet. The vascular access device according to any one of claims 1 to 9.

12. The axis of the second portion of the lumen of the port extends at an angle with respect to the first portion, and the second portion is disposed proximal to the valve or needle-penetrable septum. The vascular access device according to claim 11.

13. The outermost diameter of the body of the port is less than twice the outer diameter of the catheter. The vascular access device according to any one of claims 1 to 12.

14. The outermost diameter of the body of the port is greater than the range between 170% and 130% of the outer diameter of the catheter. The vascular access device according to any one of claims 1 to 13.

15. The body of the port includes a sonic generating material or a radiopaque material. The vascular access device according to any one of claims 1 to 14.

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

17. The vascular access device further includes a catheter lock configured to fix the catheter to the outlet. The vascular access device according to any one of claims 1 to 16.

18. A port placement system configured to place a port subcutaneously, 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, the port, A catheter coupled to the outlet of the port and in fluid communication with the outlet of the port, A placement tool, A housing defining a cavity configured to receive the port therein, the housing including an elongate opening extending longitudinally along a bottom surface of the housing and communicating with the cavity, A handle extending from the housing, A nose portion hingedly coupled to the housing at an end opposite the handle and configured to move between a closed position and an open position to release the port from the cavity An indwelling tool including A port indwelling system comprising.

19. The port indwelling system according to claim 18, wherein the nose portion defines a tapered outer contour.

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

21. The port indwelling system according to claim 20, further including a blade disposed at the leading edge.

22. The port indwelling system according to any one of claims 18 to 21, further including a drive button disposed on the handle and configured to move the nose portion between an open position and a closed position.

23. The port indwelling system according to any one of claims 18 to 22, wherein the width of the elongated opening is smaller than the diameter of the port and larger than the diameter of the catheter.

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

25. The port indwelling system according to claim 24, wherein the width of the elongated opening of the handle is larger than the diameter of the port.

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

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

28. The port indwelling system according to any one of claims 18 to 27, wherein the lumen of the port includes a valve or a septum penetrable by a needle.

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

30. The port indwelling system according to any one of claims 18 to 29, further including a catheter lock configured to fix the catheter to the port.

31. The port according to any one of claims 18 to 30 further includes a nub extending from a bottom edge of the inlet, the nub being configured to receive the access needle while colliding with the access needle and direct the access needle toward the inlet.

32. The port according to any one of claims 18 to 31 includes a sonic generating material or a radiopaque material.

33. The axis of the lumen of the port is aligned with the axis of the lumen of the catheter, according to claim 29 of the port indwelling system.

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