Patent Application
20240269448
Briefly summarized, embodiments disclosed herein are directed to a low profile, injectable subcutaneous vascular access system and associated methods thereof. The system includes a low profile port, defining an outer profile that is substantially the same as an outer profile of a catheter coupled thereto. The low-profile port can be placed subcutaneously and requires a much smaller insertion site that conventional ports. As such fewer stiches, or no stitches, are required to close the insertion site similar to that of an injection, making the port “injectable” and improving patient recovery times, reducing scaring, and improving aesthetics. Further, a lumen of the port can define the same diameter or cross-sectional shape as that of the catheter lumen, and can align with the catheter lumen, providing little to no resistance in fluid flow therethrough. Also disclosed are placement tools configured to form an insertion site and place the port subcutaneously.
Disclosed herein is a vascular access device configured to be disposed subcutaneously including, a catheter defining a catheter lumen and providing fluid communication with a vasculature of a patient 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.
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 a needle penetrable septum configured to control a fluid flow therethrough. 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 a diameter of the lumen of the catheter in the relaxed state. In some embodiments, the cross-sectional area of the port lumen is equal to a cross-sectional area of the lumen of the catheter in the relaxed state.
In some embodiments, the cross-sectional shape of the port lumen is equal to a cross-sectional shape of the lumen of the catheter in the relaxed state. In some embodiments, the vascular access device further includes a nub extending proximally from a lower edge of the inlet and configured to receive an access needle, impinging thereon, and direct the needle towards the inlet. In some embodiments, the nub includes a side wall extending perpendicular from an edge of the nub and extending longitudinally, the side wall configured to direct a needle impinging thereon towards the inlet. In some embodiments, an axis of a portion of the port lumen aligns with an axis of the catheter lumen. In some embodiments, the portion of the port lumen extends between a septum and the outlet.
In some embodiments, an axis of a second portion of the port lumen extends at an angle relative to the first portion, the second portion disposed proximal of the septum. In some embodiments, an outer diameter of the port body is less than double an outer diameter of the catheter. In some embodiments, an outer diameter of the port body is between than 170% and 130% an outer diameter of the catheter. In some embodiments, the port body includes an echogenic or radiopaque material. In some embodiments, the vascular access device further includes an insertion tool including a tool head having a sharpened front edge and configured to form a tissue pocket to receive the vascular access device. In some embodiments, the vascular access device further includes a cathlock configured to secure the catheter to the outlet.
Also disclosed is a port placement system configured for placing a port subcutaneously 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 and in fluid communication with the distal outlet, and a placement tool including, a housing defining a cavity configured to receive the port therein, and including an elongate opening extending longitudinally along a bottom surface thereof and communicating with the cavity, a handle extending from the housing, and a nose portion hingedly coupled to the housing at an opposite end from the handle, and configured to transition between a closed position and an open position to release the port from the cavity.
In some embodiments, the nose portion defines a tapered outer profile. In some embodiments, the placement tool includes a sharpened front edge configured to form one of an incision site or a tissue pocket. In some embodiments, the port placement system further includes a blade disposed in the front edge. In some embodiments, the port placement system further includes an actuator button disposed on the handle and configured to transition the nose portion between the open position and the closed position. In some embodiments, a lateral width of the elongate opening is less than a diameter of the port and greater than a diameter of the catheter.
In some embodiments, the handle defines a cavity and an elongate opening, the handle cavity communicating with the cavity of the housing and the handle elongate opening communicating with the elongate opening of the housing. In some embodiments, a lateral width of the handle elongate opening 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 needle penetrable septum.
In some embodiments, the outlet of the port is defined by a stem configured to be inserted into a lumen of the catheter. In some embodiments, the port placement system further includes a cathlock configured to secure the catheter to the port. In some embodiments, the port further includes a nub extending from a bottom edge of the inlet and configured to receive an access needle, impinging thereon, and direct the needle towards the inlet. In some embodiments, the port includes an echogenic or radiopaque material. In some embodiments, an axis of the lumen aligns with an axis of the catheter.
Also disclosed is a method of placing a port having a catheter coupled thereto including, disposing the port within a housing of an insertion tool, the tool including an elongate opening extending along a bottom surface of the housing and communicating with a cavity of the housing, urging a front edge the tool subcutaneously, forming a tissue pocket to receive the port, transitioning a nose portion of the housing to an open position, withdrawing the insertion tool proximally, and disengaging the tool from the port and the catheter.
In some embodiments, the elongate opening of the housing defines a lateral width that is 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 from the front edge. In some embodiments, the handle defines a handle cavity communicating with the cavity of the housing. In some embodiments, the handle includes an elongate opening extending along a lower surface thereof and communicating with the elongate opening of the housing. In some embodiments, a lateral width of the elongate opening of the handle is greater than a diameter of the port.
In some embodiments, the method further includes forming an incision site with the front edge of the insertion tool. In some embodiments, the method further includes actuating an actuator disposed on the tool to transition the nose portion between the closed position and the open 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.
A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.
Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and 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 in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.
With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a “proximal length” of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A “proximal end” of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.
With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a “distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A “distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.
To assist in the description of embodiments described herein, as shown in
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.
The catheter 90 can include a compliant elongate tube, or body, configured to engage the port stem 120 in an interference fit. A distal end of the catheter 90 can be disposed within a vasculature of a patient to provide fluid communication therewith. A proximal end of the catheter 90 can be configured to be stretched over the port stem 120 to provide a fluid-tight seal there between. Worded differently, the stem 120 can be configured to engage an inner lumen of the catheter 90. The catheter 90 can be elastically deformed to receive the port stem 120 therein. In a relaxed state, the catheter lumen 92 can define a diameter, a cross-sectional area, and a cross-sectional shape (e.g. circular, semi-circular, elliptical, or the like). In an embodiment, a cathlock 80 can engage an outer surface of the catheter 90 and can further secure the catheter 90 to the port stem 120.
In an 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 an embodiment, the outlet 124 can be defined by the port stem 120. In an embodiment, an inlet 122 can be defined as a proximal-most opening to the lumen 140 and can be configured to receive a needle therein. In an 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 an embodiment, the port lumen 140 can define a substantially uniform diameter along the entire axial length thereof, i.e. from the inlet 122 to the outlet 124. In an embodiment, the port lumen 140 can define a substantially uniform lateral cross-sectional area along the entire axial length thereof. In an embodiment, the port lumen 140 can define a substantially uniform lateral cross-sectional shape along the entire axial length thereof.
In an embodiment, a diameter of the port lumen 140 can be equal to a diameter of the catheter lumen 92. In an embodiment, a cross-sectional area of the port lumen 140 can be equal to a cross-sectional area of the catheter lumen 92. In an embodiment, a cross-sectional shape of the port lumen 140 can be equal to a cross-sectional shape of the catheter lumen 92. In an embodiment, an axis of the port lumen 140 can extend parallel to, or align with, an axis of the catheter lumen 92. In an embodiment, the port 100 can further include a needle-penetrable septum 130, valve, or similar structure configured to control a fluid flow through the lumen 140.
Advantageously, the port lumen 140 can provide a direct fluid path with the catheter lumen 92, with little to no variation is diameter, cross-sectional area, or cross-sectional shape, to minimize any fluid resistance therethrough. Further, an axis of the port lumen 140 can align with an axis of the catheter lumen 92 to minimize any fluid resistance therethrough. This allows for increased flow velocities through the port 100, through the catheter 90 and into the vasculature of the patient.
In an embodiment, an outer diameter or outer profile of the port body 110 can be substantially the same, or slightly larger than, an outer diameter or outer profile of the catheter 90. In an embodiment, the diameter of the port (DP) at the widest or tallest point, can be less than double the diameter of the catheter (DC). Worded differently, a maximum diameter of the port (DP) along an axis extending perpendicular to the longitudinal axis can be less than 200% of the diameter of the catheter (DC) along the same axis. In an embodiment, the diameter of the port (DP) can be between 130% and 170% of the diameter of the catheter (DC). Advantageously, the maximum dimensions of the port 110 can be substantially the same, or only slightly larger than the dimensions of the catheter 90. As such, placing the port 110 can require the same sized incision site as would be required to place the catheter 90 alone. Advantageously, the incision site required to place the port can require fewer stiches to close, or require no stitches to close the site, improving patient recovery times, reducing scaring and improving aesthetics.
In an embodiment, as shown in
In an embodiment, as shown in
In an embodiment, a lower surface of the port body 110 can define a substantially flat surface. In an embodiment, a portion of the port 110 can include an echogenic or radiopaque material configured to facilitate locating and accessing the port under medical imaging.
In an embodiment, the port 200 can define a lumen 240 extending from an inlet 222 disposed at a proximal end, to an outlet 224 disposed at a distal end. In an embodiment, the outlet 224 can be defined by the port stem 220 of the port stem 220. In an embodiment, the port lumen 240 can define a substantially uniform diameter along the entire axial length thereof, i.e. from the inlet 222 to the outlet 224. In an embodiment, the port lumen 240 can define a substantially uniform cross-sectional area along the entire axial length thereof. In an embodiment, the port lumen 240 can define a substantially uniform lateral cross-sectional shape along the entire axial length thereof.
In an embodiment, a diameter of the port lumen 240 can be equal to a diameter of the catheter lumen 92. In an embodiment, a cross-sectional area of the port lumen 240 can be equal to a cross-sectional area of the catheter lumen 92. In an embodiment, a cross-sectional shape of the port lumen 240 can be equal to a cross-sectional shape of the catheter lumen 92. In an embodiment, an axis of the port lumen 240 can extend parallel to, or align with, an axis of the catheter lumen 92. In an embodiment, the port 200 can further include a needle-penetrable septum 230, valve, or similar structure configured to control a fluid flow therethrough.
Advantageously, the port lumen 240 can define a straight path with little to no variation is diameter, cross-sectional area, or cross-sectional shape, to minimize any fluid resistance therethrough. Further, the port lumen 240 can match the diameter, cross-sectional area, or cross-sectional shape of the catheter lumen 92 with little to no variation therebetween to minimize any fluid resistance between the port 200 and the catheter 90.
In an embodiment, an outer diameter or profile of the port body 210 can be the same or only slightly larger than an outer diameter or profile of the catheter 90. In an embodiment, the diameter of the port (DP) at the widest or tallest point, can be less than double the diameter of the catheter (DC). Worded differently, a maximum diameter of the port (DP) along an axis extending perpendicular to the longitudinal axis can be less than 200% of the diameter of the catheter (DC) along the same axis. In an embodiment, the diameter of the port (DP) can be between 130% and 170% of the diameter of the catheter (DC). Advantageously, the maximum dimensions of the port 210 can be substantially the same, or only slightly larger than the dimensions of the catheter 90. As such, placing the port 210 can require the same sized incision site as would be required to place the catheter 90 alone. Advantageously, the incision site required to place the port 200 can be substantially less than conventional ports and require fewer stiches to close, or require no stitches, to close the site. This can lead to improved recovery times, less scarring and improved aesthetics for the patient.
In an embodiment, the port 210 can include a nub 250 extending proximally from the port 200, i.e. away from the inlet 222 at an opposite end of the port 200 from the stem. The nub 250 can extend parallel with a bottom surface of the port body 210 and can be configured to guide a needle towards the inlet 222. Optionally, the nub 250 can include one or more side walls 252 angled and configured to guide a needle towards the septum 230. In an embodiment, the nub 250 can include a guide channel 254 extending longitudinally and configured to receive a tip of a needle therein and guide the needle tip towards the inlet 222. In an embodiment, a portion of the port 210 can include an echogenic or radiopaque material configured to facilitate locating and accessing the port under medical imaging.
In an embodiment, the head 310 can define a tapered shape extending longitudinally along one of the horizontal or vertical planes. In an embodiment the head 310 can define a spade-like shape. In an embodiment, the head 310 can define a profile that is similar in profile to the nub 150, 250 and or port body 110, 210 of the ports 100, 200. As such, as the head 310 is urged subcutaneously, the head 310 can define a tissue pocket that matches the shape, or outer profile, of the port 100, 200 minimizing subcutaneous travel.
In an embodiment, the head 310 can define a substantially flat lower surface 312 and a beveled front surface 314 each extending rearwards from a front edge 330. As shown in
In an embodiment, the head 310 can include a sharpened front edge 330, configured to separate subcutaneous tissues to form a tissue pocket as the head 310 is urged forward, subcutaneously. In an embodiment, the front edge 330 can be configured to form an insertion site. In an embodiment, the front edge 330 can include a blade, or similar structure, formed of a different material from that of the head 310, and configured to form an insertion site and/or separate subcutaneous tissues to form a tissue pocket. In an embodiment, a largest transverse or lateral diameter of the head 310 (DH) can be the same or slightly larger than the largest transverse or lateral diameter (DP) of the port 100, 200.
In an embodiment, the handle 420 can define a handle cavity 422 that communicates with the cavity 412 of the housing 410. The handle 420 can include an elongate opening 424 extending along a bottom surface and communicating with the handle cavity 422. The handle opening 424 can axially align with, and/or communicate with, the elongate opening 414 of the housing 410. The handle opening 424 can define a lateral width that is greater than an outer-most diameter (DP) of the port 100, 200. As such, the handle opening 424 can allow a clinician to load a port 100, 200 and catheter 90 assembly into the housing cavity 412, to be retained therein, by passing the port 100, 200 through the handle opening 424 into the handle cavity 422 and advancing the port 100, 200 forwards into the cavity 412 of the housing 410.
In an embodiment, the housing 410 can include a nose portion 440 hingedly coupled to the housing 410 and transitionable between a closed position and an open position. In an embodiment, the nose portion 440 can define the front edge 430. In an embodiment, a portion of the housing 410 can define the front edge 430. In an embodiment, the nose portion 440 in the closed position can co-operate with a portion of the housing 410 to define the front edge 430. The nose portion 440 in the closed position (
In an embodiment, the handle 420 can include an actuator 450 functionally coupled with the nose portion 440 and configured to transition the nose portion between the open position and the closed position. In an embodiment, the actuator 450 can be a push button and include one or more gears, levers, biasing members, or similar mechanisms configured to transition the nose portion 440 between the open position and the closed position when the push button is actuated. It will be appreciated that the push button is exemplary and various sliders, dials, thumb wheels, levers, or similar actuators are contemplated.
In an exemplary method of use a port placement system 400 is provided generally including a tool 402 and a port, e.g. port 100, 200, as described herein. In an embodiment, the port 100, 200 can be loaded into the tool 402 by the clinician. In an embodiment, the port 100, 200 can be pre-loaded within the tool 402. The clinician can load the port 100, 200 into the tool 402 by passing the port 100, 200 through a handle opening 424 and into the handle cavity 422. A lateral width of the handle opening 424 can be wider than an outer diameter (DP) of the port 100, 200 and catheter 90 assembly to allow the port 100, 200 and catheter 90 assembly to pass therethrough. A longitudinal axis of the port 100, 200 and catheter 90 assembly can laterally align with a central axis 70 of the tool 420. The clinician can the advance the port 100, 200 forwards, along the central axis 70 until the port 100, 200 is seated within the housing 410 and retained therein.
In an embodiment, one of the housing cavity 412 or the handle cavity 422 can include one or more pawls, detents, or abutments configured to allow the port 100, 200 to advance forwards into the housing cavity 412, but can abut against one of the port 100, 200 or catheter 90 to mitigate retrograde movement of the port 100, 200 from the housing cavity 412. With the port 100, 200 disposed within the housing cavity 412, the catheter 90 can extend rearwards through the handle cavity opening 424. A clinician can grasp the handle 420 to manipulate the housing 410 with the port 100, 200 disposed therein. Optionally, the clinician can grasp the handle 420 and the catheter 90 together to manipulate the housing 410 and mitigate retrograde movement of the port 100, 200 from the housing cavity 412.
The clinician can then urge the front edge 430 subcutaneously. Optionally the clinician can form an incision site in skin surface for the housing 410 to pass therethrough, prior to urge the front edge 430 subcutaneously. In an embodiment, the front edge 430 of the tool can be sharpened, or can include a blade or similar structure, configured to for an incision site as the housing 410 is urged subcutaneously. In an embodiment, the blade can be formed of a different material having different mechanical properties from that of the housing 410. As the front edge 430 is urged subcutaneously the shape of the nose portion 440 can be configured to separate the subcutaneous tissues and form a tissue pocket.
When the tissue pocket is formed, the clinician can actuate the actuator 450 to transition the nose portion 440 from the closed position to the open position. With the nose portion 440 in the open position, the port 100, 200 disposed within the housing cavity 412 can advance forwards of the tool 402 and be disposed within the tissue pocket. In an embodiment, the clinician can manipulate the catheter 90 to advance the port 100, 200 forwards from the housing cavity 412, the tool 402 can then be withdrawn proximally. In an embodiment, with the nose portion 440 in the open position, the port 100, 200 can remain 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 port 100, 200 in place. In an embodiment, as the tool 402 is withdrawn proximately, the catheter 90 can pass axially through handle cavity opening 424 and through the housing cavity opening 414 disposed along a lower surface until the tool 402 disengages with the port 100, 200 and catheter 90 assembly.
While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US21/31407 | 5/7/2021 | WO |
