Current methods of fluidly connecting a vascular access device (“VAD”), e.g. an access port having one or more reservoirs, to a catheter include stretching the catheter over the access port stem. This can be challenging when the catheter, access port and port stem are located within a subcutaneous tissue pocket of a patient. Furthermore, stretching the catheter over the port stem within the subcutaneous pocket can lead to incorrect assembly, slippage, or accidental trauma to the tissue pocket. A more secure connection would allow for higher fluid flow between the catheter and the port while preventing fluid leakage from the connection. Thus, it would be beneficial to couple the catheter and the access port together more quickly, more easily and more securely within the subcutaneous pocket. Disclosed herein is a coupling system and method of use that address the foregoing.
Disclosed herein is fluid coupling device configured to couple a catheter to an access port including, in some embodiments, a toothed grip connector system configured to retain an end portion of a catheter, the toothed grip connector system further including a recess extending longitudinally from a first end of the coupling device and including an internal stem disposed therein. The fluid coupling device includes a gripping member extending radially about the internal stem and including a plurality of teeth extending radially inward therefrom, the plurality of teeth configured to engage an outer surface of the end portion of the catheter to prevent longitudinal movement in at least a first direction following insertion of the end portion of the catheter into the recess; and a sealing member configured to impinge an outer surface of the catheter to provide a seal between the end portion of the catheter and the internal stem.
In some embodiments, the fluid coupling device further includes a male-end quick connector disposed at a second end thereof, and configured to engage a female-end quick connector coupled to an access port.
In some embodiments, the fluid coupling device includes where the plurality of teeth are angled towards a second end of the coupling device, opposite the first end.
In some embodiments, the fluid coupling device includes where one of the gripping member or the sealing member is retained within a groove in a wall of the recess, the groove extending annularly about the internal stem.
In some embodiments, the fluid coupling device includes a protrusion that extends radially inward from a wall of the recess and is configured to abut against one of the gripping member or the sealing member to inhibit longitudinal movement thereof in at least the first direction.
In some embodiments, the fluid coupling device includes where the sealing member includes one of a silicone, polymer, elastomer, or rubber materials that exhibit watertight properties.
In some embodiments, the fluid coupling device includes where the sealing member is located proximate the first end and the gripping member is located proximate the second end.
In some embodiments, the fluid coupling device includes where the sealing member is located proximate the second end and the gripping member is located proximate the first end.
In some embodiments, the fluid coupling device further includes a tool, a portion thereof configured to extend into the recess between an outer surface of the catheter and a tooth of the plurality of teeth, to disengage the plurality of teeth from the catheter and allow the catheter to be withdrawn along the first longitudinal direction.
Also disclosed is a method for placing a catheter and an access port, including placing the access port into a tissue pocket; positioning a distal end of the catheter at a target location in the patient; inserting a proximal end of the catheter into a toothed grip connector system disposed at a first end of a fluid coupling device, the toothed grip connector system including a recess, an internal stem disposed within the recess, a gripping member extending annularly about the internal stem and a sealing member, the gripping member including a plurality of teeth extending radially inward and configured to engage an outer surface of the catheter to inhibit withdrawal of the catheter from the toothed grip connector system; and providing fluid communication between the catheter and the port.
In some embodiments, the method includes where the fluid coupling device is formed integrally with a port and configured to provide fluid communication thereto.
In some embodiments, the method includes where the second end of the coupling device is configured to engage the port using one of quick connect system, threaded engagement, press-fit, snap fit, adhesive, bonding or welding, to provide fluid communication thereto.
In some embodiments, the method further includes impinging a surface of the sealing member against the outer surface of the catheter; and creating a seal between an inner surface of the catheter and the internal stem.
In some embodiments, the method further includes sliding a disengagement tool into the recess between the plurality of teeth and the outer surface of the catheter; flexing the plurality of teeth radially outward to disengage the outer surface of the catheter; and withdrawing the catheter from the toothed grip connector system.
In some embodiments, the method includes where the gripping member includes a bi-stable configuration including a first stable configuration where the plurality of teeth are angled towards a second end of the fluid coupling device, and a second stable configuration where the plurality of teeth are angled towards a first end of the fluid coupling device.
In some embodiments, the method includes where the second end of the coupling device includes a male-end quick connector configured to couple with a female-end quick connector on the port.
In some embodiments, the method includes where the second end of the coupling device includes a female-end quick connector configured to couple with a male-end quick connector on the port.
Also disclosed herein is a method for connecting a catheter to an access port including creating a port pocket in a patient, placing the access port into the port pocket, the access port including a female connector fitting. The method includes positioning a distal end of the catheter at a target location in the patient, inserting a proximal end of the catheter into a coupling device outside of the port pocket, the coupling device including a first end designed to receive the proximal end of the catheter, the first end including a gripping member to prevent movement of the catheter in the direction away from the coupling device following insertion of the proximal end of the catheter into the first end, and a second end opposite of the first end, the second end including a male connector fitting. The method includes inserting the male connector fitting into the female connector fitting in the port pocket to lock the coupling device to the access port and to place the catheter in fluid communication with the access port.
Also disclosed herein is a fluid coupling system configured to couple a catheter to an access port including a male-end quick connector including an external stem extending along a longitudinal axis and defining a lumen, the stem including a groove extending annularly, and a female-end quick connector defining a lumen and configured to receive the stem of the male-end quick connector. The female-end quick connector includes a collar locking mechanism slidably engaged therewith, the collar locking mechanism transitionable between a locked configuration and an unlocked configuration, and including a tab configured to engage the groove in the locked configuration to releasably retain the stem within the female-end quick connector.
In some embodiments, the fluid coupling system further includes a biasing member configured to bias the collar locking mechanism to the locked position.
In some embodiments, the fluid coupling system further includes a guide structure configured to guide the collar locking mechanism between the unlocked and the locked configuration.
In some embodiments, the fluid coupling system further includes an actuator, disposed of within the lumen of the female-end quick connector and configured to open a valve, the valve configured to control fluid communication between the lumen of the female-end quick connector and the lumen of the male-end quick connector.
In some embodiments, the fluid coupling system includes where the male-end quick connector is coupled to a catheter and the female-end quick connector is coupled to a port.
In some embodiments, the fluid coupling system includes where the female-end quick connector is coupled to a catheter and the male-end quick connector is coupled to a port.
In some embodiments, the fluid coupling system includes where the male-end quick connector is coupled a fluid coupling device including a toothed grip connector system disposed at an opposite end thereof, and configured to engage a catheter.
In some embodiments, the fluid coupling system includes where the collar locking mechanism is slidably engaged with the female-end quick connector along an axis extending parallel to the longitudinal axis.
In some embodiments, the fluid coupling system includes where the collar locking mechanism is slidably engaged with the female-end quick connector along an axis extending perpendicular to the longitudinal axis.
These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail.
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.
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.
In an embodiment, a coupling system 100 may be employed to couple the catheter 128 to the port stem 132 in a secure connection to allow for higher fluid flow between the catheter 128 and the port 130 while preventing fluid leakage from the connection. In some embodiments, the coupling system 100 may include a toothed grip connector system 104 configured to couple the catheter 128 to the coupling system 100 and a rapid release connector system 106 configured to couple the port 130 to the coupling system 100. In an embodiment, the coupling system 100 can be coupled to the catheter 128 by urging the coupling system 100 in a first axial direction (A), substantially parallel to a longitudinal axis. The catheter 128 and coupling system 100 can then be connected to the port 130 by urging the catheter 128 and coupling system 100 in a second axial direction (B), substantially parallel to a longitudinal axis.
Advantageously, the system 100 can provide a faster, more simplified connection between the catheter 128 and the access port 130 and further mitigates slippage, trauma, and fluid leakage under pressure within the tissue pocket. The connection between the catheter 128, coupling system 100, and stem 132 can be made quickly and with ease within the tissue pocket and ensures proper fluid communication between the catheter 128 and the access port 130.
The system 100 can generally include a connector body (“body”) 102 extending between a first end 144 to a second end 146. In some embodiments, the first end 144 is proximate the catheter 128 and the second end 146 is proximate the port stem 132. In an embodiment, the first end 144 can include the toothed grip connector system 104 and the second end 146 can include the rapid release connector system 106. For ease of explanation, embodiments of the coupling system 100 are described in terms of coupling a single lumen catheter. However, it will be appreciated that in some embodiments, the system 100 may be designed to couple two or more lumens of the catheter 128 with two or more lumens of a port stem 132. These and other configurations of multi-lumen catheter connectors are considered to fall within the scope of the present invention.
The toothed grip connector system 104 can generally include a recess 152 having a first opening 108 defining a first opening inner diameter 112. In some embodiments, the first opening inner diameter 112 is bigger than an outer diameter of the catheter 128 and is configured to receive a portion of the catheter 128 therein. In some embodiments, the toothed grip connector system 104 may be configured to selectively secure a portion of the catheter 128 within the recess 152 and provide a fluid tight seal between the catheter 128 and the coupling system 100, as will be described in more detail herein. In an embodiment, the rapid release connector system 106 can generally include a second opening 110 defining a second opening inner diameter 114. In some embodiments, the second end 146 includes a male-end quick connector 116 that engages a female-end quick connector 142 of the port 130 as part of the rapid release connector system 106, as discussed in more detail herein.
In some embodiments, the gripping member 124 includes a gripping member ring (“ring”) 150 and a plurality of teeth (“teeth”) 126 that extends radially inward therefrom and are angled with respect to the longitudinal axis. In an embodiment, the teeth 126 are angled towards the first end 144, towards the second end 146, or combinations thereof In an embodiment, the gripping member 124 can be configured to allow the teeth 126 to flex radially outward from a resting position. As the catheter 128 is urged into the first end 144, the teeth 126 can flex radially outward to receive the catheter 128 therebetween.
In some embodiments, one or both of the teeth 126 and the gripping member ring 150 can be constructed of the same material. In some embodiments, one or both of the gripping member ring 150 and the teeth 126 can be formed of a plastic, a polymer, a metal, an alloy, a composite, combinations thereof, or the like, and can provide resilient or rigid mechanical properties. In an embodiment, the teeth 126 can be formed of a first material and the gripping member ring 150 can be formed of a second material. For example, in some embodiments, the gripping member 124 can be stamped from a single piece of metallic material, or can be stamped from multiple pieces of metallic material and attached together by adhesive, bonding, welding, or the like. In some embodiments, the gripping member 124 can be injection molded or 3D printed from a plastic, synthetic polymer, or the like. In some embodiments, the gripping member ring 150 may be constructed of a flexible material, while the plurality of teeth 126 may be constructed of a rigid metallic material and coupled to the gripping member ring 150. In some embodiments, the flexibility of the gripping member ring 150 can allow for the teeth 126 to be to be flexed radially outward to allow for removal of the catheter 128 from the coupling system 100.
In an embodiment, the teeth 126 may be angled towards the second end 146. This allows the catheter 128 to be urged inwards into the recess 152 and received between the teeth 126. The teeth 126 may then engage an outer surface 166 of the catheter 128 and retain a portion of the catheter 128 between the teeth 126 and the internal stem 118 to inhibit withdrawal of the catheter 128 from the recess 152. In some embodiments, the teeth 126 may or may not contact the internal stem 118.
In an embodiment, the user can insert a disengagement tool 200 into the first end 144 to release the catheter 128 from toothed grip connector system 104. For example, as shown in
In an embodiment, the disengagement tool 200 can be a separate structure from the toothed grip connector system 104 and engaged therewith to disengage the catheter 128, as described herein. In an embodiment, the disengagement tool 200 can be slidably coupled with the toothed grip connector system 104 and can be actuated by a button or similar mechanism to disengage the catheter 128.
In an embodiment, the gripping member 124 can include a bi-stable configuration where in a first stable configuration the plurality of teeth 126 are angled towards the second end 146 (e.g. as shown in
In some embodiments, the toothed grip connector system 104 includes a sealing member 122. The sealing member 122 defines a substantially toroidal shape and can be made of silicone, polymer, elastomer, rubber, synthetic polymers, plastics, organic non-plastic polymers, rubber alternatives or other materials that are able to form a fluid tight seal between the catheter 128 and an inner wall 220 of the recess 152. In some embodiments, the gripping member 124 and sealing member 122 are disposed annularly about the internal stem 118 within the recess 152. In some embodiments, an outer perimeter of one of the gripping member 124, the sealing member 122, or both are retained within an annular groove 240 disposed in the inner wall 220 of the recess 152. In an embodiment, one or both of the gripping member 124 and the sealing member 122 can be retained within the recess 152 or within the annular groove 240 with adhesive, welding, bonding, interference fit, press-fit, or snap-fit engagement. In some embodiments, in a disengaged state, the teeth 126 can engage the internal stem 118 to retain the gripping member 124 within the recess. In an embodiment, in a disengaged state as illustrated in
In some embodiments, the gripping member 124 can be coupled to the sealing member 122 by adhesive, bonding, welding, or the like. In some embodiments, the gripping member 124 can also be configured to provide a fluid tight seal between the catheter 128 and the internal stem 118. For example, the gripping member ring 150 can include a silicone rubber material, or the like, and can include a plurality of teeth 126 extending radially therefrom, as described herein. In an embodiment, the gripping member ring 150 provides the sealing action and the plurality of teeth 126 provide the gripping action. In an embodiment, the gripping member 124 or the sealing member 122 can be secured in place by at least one protrusion 120, or similar mechanical means. In some embodiments, the protrusion 120 extends radially inward from the inner wall 220 of the recess 152 and is configured to abut against the gripping member 124 to inhibit longitudinal movement thereof In some embodiments, the at least one protrusion 120 is configured to abut against the sealing member 122 to inhibit longitudinal movement thereof In an embodiment, one of the gripping member 124 or the sealing member 122 can be secured in place by an adhesive, welding, bonding, combination thereof, or the like.
In some embodiments, the rapid release connector system 106 can couple the coupling system 100 to the access port 130. For example, the rapid release connector system 106 includes a male-end quick connector 116, disposed on the coupling system 100, and is configured to slidably engage the female-end quick connector 142, disposed on the access port 130, to provide fluid communication between the catheter 128 and the access port 130. In some embodiments, the male-end quick connector 116 can include an external stem extending longitudinally and including a chamfered edge to facilitate engagement. In some embodiments, the male-end quick connector 116 including the external stem includes a groove 600, extending longitudinally and configured to facilitate alignment of the male-end quick connector 116 within the female-end quick connector 142. The female-end quick connector 142 include a recess extending longitudinally and configured to receive the male-end quick connector 116 therein.
In some embodiments, the female-end quick connector 142 can be disposed on the coupling system 100 and the male-end quick connector 116 can be disposed on the access port 130. In an embodiment, the system 100 can be coupled to the port 130 with a threadable engagement, interference fit, press-fit , or snap-fit engagements, combinations thereof, or the like. In an embodiment, the coupling system 100 can be integrally formed with the port 130. In an embodiment, the coupling system 100 can be attached to the port 130 using adhesive, bonding, welding, or the like.
As illustrated in
In an embodiment, the access port lumen 182 includes a port valve 324 coupled with an actuator 320. When the male-end quick connector 116 engages the female-end quick connector 242, a tip of the male-end quick connector 116, e.g. second end 146, contacts the actuator 320 and opens the port valve 324. In an embodiment, the actuator 320 can align the connector body lumen 190 of the coupling system 100 with the lumen of the female-end quick connector 242
In an embodiment, the female-end quick connector 242 can include one or more guide structures 322 configured to guide the collar locking mechanism 272 transversely between an unlocked configuration and a locked configuration. In this embodiment, the guide structure 322 can include a rounded cylindrical protrusion 332A that extends longitudinally from the female-end quick connector 242 and slidably engages the collar locking mechanism 272. In an embodiment the protrusion 332A can be coupled to one of the actuator 320 or the port valve 324. A portion of the male-end quick connector 116 can depress the cylindrical protrusion 332A when engaged with the female-end quick connector 242 and open the port valve 324. As shown, the collar locking spring 278 biases the collar locking tab 276, and thus the collar locking mechanism 272, towards the locked configuration.
In an embodiment, the sealing member 122 can engage the outer surface 166 of the catheter 128 and provides a seal between the catheter 128 and the body 102 of the coupling system 100. In an embodiment, the sealing member 122 can compress the portion of the catheter 128 radially inward onto the internal stem 118 and create a seal therebetween. As shown in
As shown in
In an embodiment, as shown in
In the next step in the method 500, the access port 130 is placed and secured into the tissue pocket 134 (block 504). In some embodiments, the access port 130 includes a female-end quick connector 142 that is configured to attach to a male-end quick connector 116. In some embodiments, the access port 130 includes a male-end quick connector 116 that is configured to attach to the female-end quick connector 142.
The next step in the method 500 includes positioning a distal end of the catheter 128 at a target location within the vasculature of the patient (block 506). For example, in some embodiments, the distal end of the catheter 128 may be positioned within the Inferior Vena Cava (IVC), or the like.
In an embodiment, the method 500 includes inserting a proximal end of the catheter 128 into a toothed grip connector system 104 of the coupling system 100 outside of the tissue pocket 134 (block 508). Optionally, a proximal portion of the catheter 128 may be trimmed to an appropriate length to facilitate engagement with the coupling system 100/port 130. Advantageously, the catheter 128 can be sized to the exact length while positioned within the patient. This contrasts with estimating an appropriate length of the catheter prior to placement which can lead to misalignment of the catheter within the vasculature.
The toothed grip connector system 104 includes a gripping member 124 configured to prevent withdrawal of the catheter 128 from the toothed grip connector system 104 as described herein, and a sealing member 122 configured to create a fluid tight seal between the catheter 128 and the internal stem 118. Advantageously, the proximal end of the catheter 128 can be urged into the coupling system 100 with less force than is required to stretch the catheter 128 over a port stem 132. This allows for correct assembly of the catheter 128/port 130 while ensuring a secure, fluid tight seal and a reduced chance of slippage and trauma fluid leakage under pressure to the tissue pocket during placement.
In an embodiment, a final step in the method 500 includes inserting the second end 146 of the coupling system 100 including the rapid release connector system 106 further including a male-end connector 116 into the female-end connector 142 of the port stem 132 within the tissue pocket 134 and securing a collar 172, 272 to lock the coupling system 100 to the port 130 to place the catheter 128 in fluid communication with the access port 130 (block 510).
In some embodiments, the method 500 includes a step of inserting the second end 146 that includes the rapid release connector system 106, into the port 130 within the tissue pocket 134 (block 509).
In some embodiments, the method 500 includes a last step of inserting the catheter 128 into the toothed grip connector system 104 of the coupling system 100 within the tissue pocket 134 to place the catheter 128 in fluid communication with the access port 134 (block 511).
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.
This application claims the benefit of priority to U.S. Provisional Application No. 63/066,003, filed Aug. 14, 2020, which is incorporated by reference in its entirety into this application.
Filing Document | Filing Date | Country | Kind |
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PCT/US2021/045743 | 8/12/2021 | WO |
Number | Date | Country | |
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63066003 | Aug 2020 | US |