CATHETER ADAPTER SYSTEM FOR PROXIMALLY TEARABLE CATHETERS - Patent application

Abstract

The embodiments disclosed herein relate to a connection system comprising a port, a catheter, a cath lock and an adapter. The adapter can be coupled to a proximal end of the catheter, and the cath lock can cooperate with the adapter to secure the catheter to the port in a fluid-tight engagement. One of the cath lock or the adapter can threadably engage the port and utilize mechanical advantage to radially compress the catheter to ensure a fluid-tight seal. The system can further comprise an insertion tool configured to facilitate securing the adapter to the catheter or the adapter or cath lock to the port. The adapter can be provided as a separate structure or can be coupled to the cath lock. Engagement of the adapter with the catheter can be signaled by an audible click. Optionally, the adapter can comprise a skirt configured to compress the catheter onto the adapter stem.

Description

[Technical Field]

[0001] The present disclosure relates to a catheter adapter system for a proximally trimmable catheter. [Background technology]

[0002] Briefly summarized, embodiments disclosed herein relate to a cathlock system for coupling a proximally trimmable catheter and a port. The proximally trimmable catheter allows for post-placement sizing of the catheter. When placing the catheter and port assembly, the location of the catheter's distal tip can be important to the effectiveness of the procedure. For example, when placing a catheter in the superior vena cava, if the distal tip of the catheter does not reach the target area, the effectiveness of the medication is reduced. If the distal tip is advanced too far, it can cause arrhythmia. The distance between the distal tip of the catheter and the port can vary because the distance between the target location, the entry site into the vasculature, and the location of the port can vary between patients and procedures. Estimating the catheter length before placement can lead to errors that result in misplacement of the distal tip.

[0003] Proximally trimmable catheters allow the distal catheter tip to be positioned at a target location before trimming the proximal portion of the catheter to a precise length. The clinician can then attach the catheter to a subcutaneous port or similar access device. However, securing the catheter to the port can be challenging. The connection must be leak-tight, especially under high-pressure infusion. Furthermore, manipulating the catheter and port within the restricted, moist environment of a subcutaneous access site can lead to slippage, undue trauma to the access site, or misplacement of the distal catheter tip. Summary of the Invention

[0004] The embodiments disclosed herein relate to a Caslock system that utilizes mechanical advantage to secure the catheter to the port stem, providing a leak-tight connection even under high pressure. Disclosed herein is a connection system for a subcutaneous port with a port stem, the connection system including: an adapter having a body and configured to connect to the port stem; an adapter stem extending from the body and configured to be inserted into a lumen of the catheter to connect the adapter to the catheter; and a cath lock having a lumen and configured to slide on an outer surface of the catheter, the cath lock having threads for engaging the port stem, such that engaging the cath lock with the port stem compresses the catheter radially inward onto the adapter.

[0005] In some embodiments, the adapter stem is configured to radially expand the catheter lumen to secure the adapter to the catheter with an interference fit. The adapter is formed from a resilient material. The adapter body engages with the port stem with one of an interference fit engagement, a press fit engagement, a snap fit engagement, or a luer-slip fit engagement. The adapter includes a skirt extending longitudinally from the body and annularly disposed around the adapter stem, the skirt configured to elastically deform radially inward to engage the outer surface of the catheter. The skirt is formed from a plurality of fingers extending longitudinally from the adapter body and annularly disposed around the adapter stem, the plurality of fingers configured to elastically deform radially inward to engage the outer surface of the catheter. A distal end of one of the plurality of fingers includes a radially inward extending protrusion configured to engage a portion of the catheter.

[0006] In some embodiments, the outer surface of the skirt comprises a threaded portion configured to threadably engage the cath lock. The cath lock comprises a body rotatably coupled to the collar, the collar comprising a protrusion configured to engage a helical groove disposed on the port, such that rotation of the collar forces the protrusion through the helical groove and longitudinally forces the cath lock. The inner surface of the collar comprises a collar locking tooth configured to engage a port locking tooth disposed on the port, the collar locking tooth configured to provide an audible or tactile indication or prevent retrograde rotation of the collar. The cath lock body and collar define a cath lock lumen, the lumen diameter in the body having a first diameter and the lumen diameter in the collar defining a second diameter greater than the first diameter, the lumen comprising a tapered portion extending from the second diameter to the first diameter. A portion of the catheter disposed on the adapter stem defines an outer diameter greater than the first diameter of the cath lock lumen and less than the second diameter of the cath lock lumen. The cathlock lumen includes a ring extending radially inward from its inner wall, the ring configured to abut against a shoulder of the adapter.

[0007] In some embodiments, the port comprises a gasket disposed between the port and the adapter and surrounding the port stem. In some embodiments, the connection system further comprises an insertion tool, the insertion tool having a handle, an adapter tool configured to engage the lumen of the adapter, or a spanner head configured to engage the collar of the cath lock. The spanner head of the insertion tool comprises a jaw configured to engage a facet of the collar, the jaw configured to facilitate rotation of the collar about the longitudinal axis. In some embodiments, the jaw comprises a lip configured to engage an undercut in a collar ridge of the collar, the lip configured to facilitate rotation of the collar about the longitudinal axis. In some embodiments, the proximal end of the catheter is trimmable. In some embodiments, the adapter comprises a pawl configured to engage a recess disposed in the cath lock in a snap-fit ​​engagement to provide an audible signal that the lumen of the catheter is fully engaged with the adapter. The port includes a port locking tooth, and the cas lock includes a cas lock locking tooth extending from a surface of the cas lock lumen, the port locking tooth configured to engage with the cas lock locking tooth in a snap fit engagement to prevent retrograde rotation of the cas lock.

[0008] Also disclosed is a cath lock system for coupling a catheter to a port, the cath lock system comprising: a port having a port stem and a stem housing surrounding a portion of the port stem and defining an opening, the stem including a flared portion; and a cath lock having a body and a collar extending longitudinally from the body, the collar configured to extend between an outer surface of the port stem and an inner surface of the stem housing opening.

[0009] In some embodiments, the port stem includes a first portion defining a first outer diameter, a flared portion defining a second outer diameter larger than the first outer diameter, and a tapered portion transitioning between the first and second outer diameters. The first outer diameter is the same as or slightly smaller than the inner diameter of the catheter's lumen in an unstressed state, and the second diameter is larger than the inner diameter of the catheter's lumen in an unstressed state. The flared portion is disposed within the stem housing. The cath lock engages with the stem housing by one of a threaded engagement, a press-fit engagement, an interference fit engagement, or a Luer slip fit engagement. The cath lock is configured to compress a portion of the catheter between the inner surface of the cath lock lumen and the outer surface of the port stem.

[0010] In some embodiments, the catheter comprises a coating having a low coefficient of friction. The lumen of the cath lock body defines a first lumen diameter, the lumen of the cath lock collar defines a second diameter larger than the first diameter, the first diameter configured to engage a first portion of the port stem, and the second diameter configured to engage a flared portion of the port stem. The outer surface of the cath lock comprises a facet or gripping feature configured to facilitate rotation of the cath lock about the longitudinal axis.

[0011] Also disclosed is an adapter configured to couple a catheter to a port, the adapter including a body defining a circular cross-sectional shape, the body including a protrusion disposed on an outer surface of the body, the protrusion configured to engage a helical groove disposed on the port, and an adapter stem extending longitudinally from the body and configured to engage the lumen of the catheter with an interference fit.

[0012] In some embodiments, the adapter further comprises a cath lock slidably engaged with the outer surface of the catheter, the cath lock configured to compress a portion of the catheter against the adapter stem. In some embodiments, the adapter further comprises a skirt extending longitudinally from the adapter body and surrounding the adapter stem, the skirt configured to engage the outer surface of the catheter and resiliently deflect to compress a portion of the catheter against the adapter stem. The skirt comprises a plurality of fingers configured to resiliently deflect to compress a portion of the catheter against the adapter stem. The body is configured to rotate to engage the protrusion with the helical groove and urge the body longitudinally. The body is configured to fit within a socket disposed within the port, the helical groove being disposed on an inner surface of the socket.

[0013] Also disclosed is a method of coupling a catheter to a port, the method including positioning a distal portion of the catheter within the vasculature, clipping off a proximal portion of the catheter, forcing the stem of a cath lock adapter into the lumen of the catheter, rotating the cath lock to threadingly engage a portion of the port, radially compressing the proximal portion of the catheter onto the stem of the cath lock adapter, and longitudinally compressing the cath lock adapter onto the stem of the port.

[0014] In some embodiments, forcing the stem of the cath lock adapter into the lumen further comprises expanding an outer diameter of a proximal portion of the catheter. In some embodiments, the expanded outer diameter of the proximal portion of the catheter is larger than the inner diameter of the distal opening of the cath lock. In some embodiments, forcing the stem of the cath lock adapter into the lumen of the catheter further comprises one of an interference fit engagement, a press fit engagement, or a snap fit engagement. In some embodiments, the method further comprises compressing a skirt radially inward to engage the outer surface of the catheter, the skirt extending longitudinally from the body of the cath lock adapter and annularly disposed around the cath lock adapter stem. Rotating the cath lock further comprises threadingly engaging the outer surface of the skirt. The skirt comprises a plurality of fingers extending longitudinally from the body of the cath lock adapter.

[0015] In some embodiments, forcing the stem of the cath lock adapter into the lumen of the catheter includes engaging an insertion tool having a handle and an adapter tool with the lumen of the cath lock adapter. Rotating the cath lock includes engaging a spanner head of the insertion tool with a facet of a collar of the cath lock. The adapter is coupled to the cath lock, and the adapter engages the cath lock with a snap-fit ​​engagement to provide an audible sound when the adapter is forced into full engagement with the lumen of the catheter.

[0016] Also disclosed is a method of coupling a catheter to a port, which includes extending the proximal end of the catheter over the flared port stem to engage the flared port stem in an interference fit, engaging the outer surface of the collar of the cath lock with the inner surface of the stem housing, and compressing the wall of the proximal end of the catheter between the cath lock and the flared port stem.

[0017] In some embodiments, the flared port stem comprises a first portion defining a first outer diameter, a flared portion defining a second outer diameter greater than the first outer diameter, and a tapered portion transitioning between the first and second outer diameters. In some embodiments, engaging the collar with the stem housing comprises one of a threaded engagement, a press fit engagement, an interference fit engagement, or a Luer slip fit engagement.

[0018] Also disclosed is a method of coupling a catheter to a port, the method including engaging an adapter stem with the lumen of the catheter, inserting an adapter body into the port socket, and rotating the adapter body to engage the protrusion with the helical groove.

[0019] In some embodiments, the method further includes slidably engaging a cath lock over a portion of the catheter to compress the catheter onto the adapter stem. A more particular description of the present disclosure will be made by reference to specific embodiments thereof which are illustrated in the accompanying drawings. It will be understood that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of the scope of the invention. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0020] [Figure 1A] FIG. 1 is an exploded view of a port, catheter, and cath lock assembly according to an embodiment disclosed herein. [Figure 1B] FIG. 10 is a detailed enlarged view of a cathlock adapter engaged with a catheter, according to an embodiment disclosed herein. [Figure 1C] FIG. 1 is a perspective view of a port, catheter, and cath lock assembly according to an embodiment disclosed herein. [Figure 1D] FIG. 1 is a perspective view of a port, catheter, and cath lock assembly according to an embodiment disclosed herein. [Figure 2A]FIG. 1 is an exploded view of an insertion tool and a cath lock adapter according to an embodiment disclosed herein. [Figure 2B] FIG. 1 is a perspective view of an insertion tool engaged with a cath lock adapter according to an embodiment disclosed herein. [Figure 3A] FIG. 1 is a perspective view of an insertion tool according to an embodiment disclosed herein. [Figure 3B] FIG. 10 is a detailed enlarged view of an insertion tool according to an embodiment disclosed herein. [Figure 3C] 13A-13C illustrate an insertion tool engaged with a cath lock collar according to embodiments disclosed herein. [Figure 3D] 13A-13C illustrate an insertion tool engaged with a cath lock collar according to embodiments disclosed herein. [Figure 3E] 13A-13C illustrate an insertion tool engaged with a cath lock collar according to embodiments disclosed herein. [Figure 3F] FIG. 10 is a cross-sectional view of an insertion instrument engaged with a cath lock collar according to an embodiment disclosed herein. [Figure 3G] FIG. 10 is a cross-sectional view of an insertion instrument engaged with a cath lock collar according to an embodiment disclosed herein. [Figure 4A] FIG. 1 is a side cross-sectional view of a port, catheter, and cath lock assembly according to an embodiment disclosed herein. [Figure 4B] FIG. 1 is a top cross-sectional view of a port, catheter, and cath lock assembly according to an embodiment disclosed herein. [Figure 4C] FIG. 1 is a plan view of a horizontal cross section of a port, catheter, and cath lock assembly according to an embodiment disclosed herein. [Figure 4D] FIG. 1 is a plan view of a horizontal cross section of a port, catheter, and cath lock assembly according to an embodiment disclosed herein. [Figure 5A] FIG. 10 is a cross-sectional view of an insertion tool engaged with a cas lock adapter coupled with a cas lock according to embodiments disclosed herein. [Figure 5B] FIG. 5B is a detailed enlarged view of the adapter and cas lock of FIG. 5A according to an embodiment disclosed herein. [Figure 5C] FIG. 5B is a detailed enlarged view of the adapter and cas lock of FIG. 5A according to an embodiment disclosed herein. [Figure 5D] FIG. 1 is a perspective view of an insertion tool engaged with a cas lock adapter coupled with a cas lock, the cas lock being shown in wire frame, according to an embodiment disclosed herein. [Figure 5E] FIG. 10 is a cross-sectional view of an insertion tool engaged with a cas lock adapter coupled with a cas lock according to embodiments disclosed herein. [Figure 6A] 1 is an exploded cross-sectional view of a cath lock adapter, a cath lock, and a catheter according to an embodiment disclosed herein. [Figure 6B] FIG. 1 is a side view of a cas lock adapter according to an embodiment disclosed herein. [Figure 6C] 1 is a cross-sectional view of a cas lock adapter according to an embodiment disclosed herein. [Figure 6D] FIG. 1 is a side view of a cas lock adapter according to an embodiment disclosed herein. [Figure 6E] 1 is a cross-sectional view of a cas lock adapter according to an embodiment disclosed herein. [Figure 7A] FIG. 1 is an exploded view of a port, catheter, and cath lock assembly according to an embodiment disclosed herein. [Figure 7B] FIG. 2 is a perspective view of a cas lock according to an embodiment disclosed herein. [Figure 7C] 1 is a cross-sectional view of a casing lock according to an embodiment disclosed herein. [Figure 8A] 1A-1C are cross-sectional views of an exemplary method of attaching a port, catheter, and cath lock assembly according to embodiments disclosed herein. [Figure 8B] 1A-1C are cross-sectional views of an exemplary method of attaching a port, catheter, and cath lock assembly according to embodiments disclosed herein. [Figure 8C]1A-1C are cross-sectional views of an exemplary method of attaching a port, catheter, and cath lock assembly according to embodiments disclosed herein. [Figure 8D] 1A-1C are perspective views of an exemplary method of attaching a port, catheter, and cath lock assembly according to embodiments disclosed herein. [Figure 8E] 1A-1C are perspective views of an exemplary method of attaching a port, catheter, and cath lock assembly according to embodiments disclosed herein. [Figure 8F] 1A-1C are perspective views of an exemplary method of attaching a port, catheter, and cath lock assembly according to embodiments disclosed herein. [Figure 9A] FIG. 1 is a cross-sectional exploded view of an adapter, cathlock, and catheter assembly according to an embodiment disclosed herein. [Figure 9B] FIG. 1 is a cross-sectional exploded view of an adapter, cathlock, and catheter assembly according to an embodiment disclosed herein. [Figure 9C] FIG. 1 is a cross-sectional exploded view of an adapter, cathlock, and catheter assembly according to an embodiment disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0021] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that are readily separable from the specific embodiment and that, optionally, can be combined with or substituted for features of any of the other embodiments disclosed herein.

[0022] Regarding the terms used herein, it should also be understood that these terms are intended to describe certain 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 features or steps and do not provide serial or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Designations such as "left," "right," "top," "bottom," "front," and "back" are for convenience and do not imply, for example, a specific fixed location, direction, or orientation. Instead, such designations are used, for example, to reflect relative location, orientation, or direction. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0023] For example, references to the "proximal," "proximal portion," or "proximal end portion" of a catheter disclosed herein include 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 catheter 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. However, the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0024] For example, references to the "distal," "distal portion," or "distal end portion" of a catheter disclosed herein include the portion of the catheter intended to be near or within a patient when the catheter is in use with the patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter intended to be near or within a patient when the catheter is in use with the patient. For example, the "distal end" of a catheter includes the end of the catheter intended to be near or within a patient when the catheter is in use with the patient. The distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter. However, the distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0025] To aid in describing the embodiments described herein, as shown in Figure 1A, a longitudinal axis extends generally parallel to the axial length of the catheter. A lateral axis extends perpendicular to the longitudinal axis, and a transverse axis extends perpendicular to both the longitudinal and lateral axes. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0026] 1A-1D show various views of a connection system ("system") 100 including a proximally cuttable catheter 110, a port 120, a cath lock 150, and a cath lock adapter 160, according to embodiments disclosed herein. As used herein, the port 120 can be any single-lumen or multi-lumen subcutaneous or supercutanous medical access device configured to provide fluid access to the catheter 110. The system 100 includes the port 120 fluidly coupled to the proximally cuttable catheter 110 via the cath lock adapter 160 and secured in place with the cath lock 150. FIG. 1A shows an exploded view of the system 100. FIG. 1B shows a detailed close-up of the cath lock adapter 160 coupled to the proximal end of the catheter 110. FIG. 1C shows the assembly of the cath lock adapter 160 and catheter 110 coupled to a port stem 124. FIG. 1D shows a cath lock 150 secured to the port 120 to secure the catheter 110 and a cath lock adapter 160 to the port 120.

[0027] In one embodiment, the catheter 110 can define a lumen 112. However, multi-lumen catheters are also considered within the scope of the present invention. For example, as shown, the catheter 110 can define a first lumen 112A and a second lumen 112B. In one embodiment, the catheter 110 can be formed from a compliant, cuttable material such as a plastic, polymer, rubber, silicone, or the like.

[0028] In one embodiment, the port 120 may be a medical access device configured to provide fluid communication with the catheter 110. The lumen of the port 120 may be fluidly coupled to the lumen 112 of the catheter 110. As shown, the system 100 includes a dual-lumen port 120 fluidly coupled to the dual-lumen catheter 110, although it will be understood that single-lumen and multi-lumen assemblies are also considered within the scope of the present invention.

[0029] The port 120 includes a body 122 formed by a first conduit 122A and a second conduit 122B having similar shapes, each of which is in fluid communication with the lumen 112 of the catheter 110. For example, the first conduit 122A can be in fluid communication with the first lumen 112A, and the second conduit 122B can be in fluid communication with the second lumen 112B. The port body 122 includes a port stem 124 extending distally from its distal end. For example, the first port stem 124A can be in fluid communication with the first conduit 122A, and the second port stem 124 can be in fluid communication with the second conduit 122B. In one embodiment, the port 120 further includes an outer shell 126 overmolded over a portion of the port body 122. The portion of the outer shell 126 can be formed from a compliant material, such as silicone, or a similar suitable material. The first and second conduits 122A, 122B may comprise a metal such as titanium. It will be appreciated that the port body 122, or portions thereof, may comprise a variety of materials, including metal, thermoplastic, ceramic, etc. Additionally, the first and second conduits 122A, 122B, or portions thereof, may be assembled using a variety of joining methods, including a snap fit, a press fit, adhesives, ultrasonic or other welding, an interference fit, or a combination thereof.

[0030] One of the first conduit 122A or the second conduit 122B can include a generally funnel-shaped receiving cup 128 for receiving and directing a catheter support needle, or similar such medical device, for operative connection with the port 120. For example, the first receiving cup 128A can be coupled to the first conduit 122A, and the second receiving cup 128B can be coupled to the second conduit 122B. One of the first conduit 122A or the second conduit 122B can include valves 130, e.g., a first valve 130A and a second valve 130B, configured to allow a needle to fluidly engage the port and pass distally therethrough to provide fluid communication between the needle and the conduit of the port body 122, and also configured to prevent proximal fluid flow from the conduit 122.

[0031] Further details of port and catheter embodiments are described in U.S. Patent Application No. 2019 / 0232035, filed April 11, 2019, which is incorporated by reference in its entirety.

[0032] In one embodiment, the cath lock 150 can include a cath lock body 152 and a collar 154 rotatably coupled to the cath lock body 152. The cath lock body 152 can define a generally cylindrical shape and can define a cath lock lumen 156. As shown in FIGS. 4A-4C , the cath lock lumen 156 can define a generally tapered interior contour, with a distal end of the cath lock lumen 156 defining a first inner diameter (d1) and a proximal end defining a second inner diameter (d2), the second diameter (d2) being greater than the first diameter (d1). In one embodiment, the cath lock lumen 156, or a portion thereof, can provide a tapered, continuous diameter increase between the first diameter (d1) and the second diameter (d2), a stepwise diameter increase between the first diameter (d1) and the second diameter (d2), or a combination thereof. In one embodiment, the cas lock 150 may be formed from a substantially rigid or resilient material.

[0033] The cas lock collar 154 can be rotatably coupled to the cas lock body 152 and can rotate about the longitudinal axis. In one embodiment, the collar 154 can freely rotate about the longitudinal axis while remaining coupled to the cas lock body 152. In one embodiment, the cas lock collar 154 can rotate through a predetermined arc about the longitudinal axis, for example, an arc of 30° to 720°. However, larger or smaller arcs are also contemplated. In one embodiment, the cas lock collar 154 can include one or more facets 158 or similar gripping features configured to engage the insertion instrument 180 and facilitate rotation of the collar 154 about the longitudinal axis, as described in more detail herein. In one embodiment, the collar 154 can include notches, ridges, ribs, high coefficient of friction materials, or combinations thereof, etc., configured to also facilitate rotation of the collar 154 about the longitudinal axis.

[0034] In one embodiment, the cas locking collar 154 can be threadably engaged with the port 120. For example, the inner surface of the cas locking collar 154 can include one or more protrusions 172 (see FIGS. 3C and 6A ) extending radially inward therefrom, the one or more protrusions 172 configured to engage with helical grooves 174 disposed on the surface of the port body 122. Thus, rotating the collar 154 about the longitudinal axis can engage the protrusions 172 with the helical grooves 174, thereby urging the collar 154 and the cas locking body 152 longitudinally proximally. In one embodiment, the inner surface of the cas locking collar can include a helical groove configured to engage with a protrusion extending radially outward from a portion of the port body 122. Thus, rotating the collar can urge the collar 154 and the cas locking body 152 longitudinally proximally. In one embodiment, the spiral groove 174 can include a recess configured to receive the protrusion 172 when the cas lock is in the locked position (e.g., FIG. 1D ). The recess can receive the protrusion 172 and prevent any backward movement thereof, securing the cas lock 150 in the locked position.

[0035] 1A and 1C, in embodiments, the outer surface of the port 120 can include a port locking tooth 142 extending from a surface of the port body 122 proximate the port stem 124. The port locking tooth 142 can define a ridge extending parallel to the longitudinal axis and can include one or more angled or rounded surfaces extending from the ridge to the surface of the port body 122. As shown in FIG. 3C, in embodiments, the inner surface of the cassette lock collar 154 can include a collar locking tooth 144 extending therefrom. The collar locking tooth 144 can define a ridge extending parallel to the longitudinal axis and can include one or more angled or rounded surfaces extending from the ridge to the surface of the port body 122.

[0036] As shown in FIGS. 3F-3G , as the collar 154 is rotated to threadably engage the port, the collar locking tooth 144 can be configured to slide over the port locking tooth 142 in a first rotational direction, allowing the collar to tighten onto the port body 122. As the collar locking tooth 144 slides over the port locking tooth 142, the interaction can produce an audible or tactile indication, such as a “click.” The audible or tactile indication can indicate to the clinician that the collar 154 is sufficiently tightened onto the port body 122. In one embodiment, the angle of the ramp extending from the ridge can be varied to provide increased or decreased resistance between the port locking tooth 142 and the collar locking tooth 144. For example, a shallow angle of the first ramp can provide relatively low resistance, allowing the collar locking tooth 144 to slide relatively easily over the port locking tooth 144 in the first rotational direction. The relatively steep angle of the second inclined surface opposite the first inclined surface can provide a relatively high resistance, preventing the collar locking tooth 144 from sliding over the port locking tooth 144 in the second rotational direction and preventing reverse rotation of the collar 154.

[0037] 3G, collar locking tooth 144 can engage port locking tooth 142 in a second rotational direction opposite the first rotational direction to prevent further movement in the second rotational direction, thereby preventing collar 154 from loosening after collar 154 is tightened onto port body 122. In one embodiment, a clinician can apply a rotational force to collar 154 in the second rotational direction to force collar locking tooth 144 past port locking tooth 142 and release collar 154 from port body 122.

[0038] In one embodiment, a cathlock adapter ("adapter") 160 is provided as a separate structure and configured to engage the proximal end of the catheter 110. The adapter 160 may be formed from a substantially rigid or resilient material. The adapter 160 may include a body 162 and a stem 164, with the stem 164 extending from the distal end of the body 162 and configured to engage the lumen 112 of the catheter 110. For example, the adapter 160 may include a first stem 164A configured to engage the first lumen 112A of the catheter 110 and a second stem 164B configured to engage the second lumen 112B of the catheter 110. The outer diameter of at least a portion of the adapter stem 164 may be the same as or slightly larger than the inner diameter of the lumen 112 of the catheter 110 such that the stem 164 can engage the lumen 112 of the catheter 110 with an interference fit. In one embodiment, the stem 164 may include an annular protrusion, barbs, or similar structure configured to engage the catheter lumen 112 and retain the catheter 110 with the adapter 160. Advantageously, the annular protrusion may further expand the catheter 110, providing a stronger interference fit between the annular protrusion and the catheter 110.

[0039] The proximal end of the adapter body 162 can be configured to engage the port stem 124. In one embodiment, the outer diameter of the port stem 124 can be the same as or slightly smaller than the inner diameter of the lumen 166 of the adapter body 162. Thus, the port stem 124 can engage with the adapter body 162 via an interference fit, press fit, snap fit, or the like. In one embodiment, the port stem 124 can engage with the caslock adapter body 162 via a luer slip fitting. For example, one of the outer contour of the port stem 124 or the inner contour of the caslock adapter body 162 can define a tapered shape extending at an angle of 0.5° to 2° from the longitudinal axis. However, larger or smaller angles are also contemplated. Thus, the port stem 124 can define a slightly conical or frustoconical shape. Similarly, the caslock body 162 may define a tapered lumen shape configured to receive the tapered port stem 124 .

[0040] In one embodiment, the system 100 can further include an insertion tool 180 configured to facilitate engagement of the adapter 160 with the proximal end of the catheter 110 or to facilitate rotation of the cath lock collar 154, as described in more detail herein. Advantageously, the insertion tool 180 can facilitate manipulation of the cath lock 150 or adapter 160 within the restricted, moist environment of a subcutaneous access site, particularly in pediatric-sized systems or when the components of the system 100 are small in size, for example, for aesthetic reasons. FIGS. 2A-3G illustrate various details of an embodiment of the insertion tool 180. As shown in FIGS. 2A-2B , in an embodiment, the insertion tool 180 can include a handle 182 that can define a substantially elongated cylinder. However, it will be understood that handles of other shapes are also contemplated. The insertion tool 180 can be formed from a substantially rigid material, such as a plastic, polymer, metal, alloy, composite, combinations thereof, or the like. In one embodiment, the handle 182 may include gripping features such as ridges, ribs, abutments, or may include a second material disposed on the handle 182 having an increased coefficient of friction, such as silicone, rubber, a polymer, an elastomer, or the like.

[0041] The handle 182 can include an adapter device 184 extending therefrom. The adapter device 184 can be configured to releasably engage the cath lock adapter 160 to facilitate engagement of the adapter 160 with the proximal end of the catheter 110. For example, the adapter device 184 can include one or more adapter protrusions 186 configured to securely but releasably engage the lumen 166 of the cath lock adapter 160. The outer contour of the adapter protrusions 186 can closely resemble the inner contour of the adapter lumen 166. Thus, the adapter protrusions 186 can engage the adapter with a light interference fit or the like. Additionally, the distal tips of the protrusions can include beveled tips to facilitate introduction of the adapter device protrusions 186 into the adapter lumen 166.

[0042] In one embodiment, when the adapter 160 is engaged with the adapter device 184, the beveled tip of the adapter protrusion 186 can extend through the adapter lumen 166 and distally of the distal end of the adapter stem 164. Thus, when the insertion device 180 is used to push the adapter 160 into the proximal end of the catheter 110, the beveled tip can engage the catheter lumen 112 and facilitate expanding the inner diameter of the catheter lumen 112 to the outer diameter of the adapter stem 164. In one embodiment, the adapter device 184 can include one or more abutment surfaces configured to engage a surface of the adapter 160 and prevent further proximal movement relative to the insertion device 180.

[0043] In use, the adapter 160 can be slid onto the adapter tool 184, with the adapter projections 186 extending into the adapter lumen 186, until the abutment surfaces engage the surface of the adapter 160. The adapter 160 can be securely held on the adapter tool 184 by a light interference, press-fit, or snap-fit ​​engagement. The clinician can then manipulate the tool 180 to align the adapter projections 186 with the lumen 112 of the catheter 110 and push the adapter distally into the proximal end of the catheter 110. The beveled tip of the adapter projections 186 can facilitate alignment of the adapter projections 186 with the lumen 112 and / or can expand the inner diameter of the catheter lumen 112 to the outer diameter of the adapter stem 124 to fit over the adapter projections 186 and adapter stem 164. The clinician can then push the adapter stem 164 into the lumen 112 of the catheter 110. In one embodiment, the frictional force between the adapter stem 164 and the catheter lumen 112 extending thereover can be greater than the frictional force used to hold the adapter 160 onto the adapter device 184. Thus, once the adapter 160 is securely engaged with the catheter (e.g., FIG. 1B ), the clinician can withdraw the insertion device 180 proximally from the catheter 110, which will cause the adapter 160 to disengage from the adapter device 184.

[0044] 3A-3G, the insertion tool 180 can further include a spanner head 190 extending from the handle 182. The spanner head 190 can include a pair of opposing jaws 192, e.g., a first jaw 192A and a second jaw 192B. Each jaw 192 can define a jaw facet 194 configured to engage the collar facet 158. Thus, the jaws 192 of the spanner head 190 can engage the cath locking collar 154. A clinician can then manipulate the handle 192 to provide mechanical advantage and rotate the collar 154 to lock the cath locking body 152 with the port body 122.

[0045] In one embodiment, as shown in FIGS. 3A-3G , the jaw 192 can include a lip 196 extending across a minor face of the jaw 192 and extending inward toward the opposing jaw. The lip 196 can engage a ridge 198 on the collar 154 to securely releasably engage the spanner head 190 with the collar 154 in a snap-fit ​​engagement. The lip 196 can be configured to engage the collar ridge 198 in one of a first rotational direction about the longitudinal axis or a second rotational direction opposite the first rotational direction. In one embodiment, the collar ridge 198 can define an undercut portion configured to securely engage the lip 196 of the jaw 192. Advantageously, the lip 196 can hook onto the ridge 198 to provide improved leverage between the spanner head 190 and the collar 154 and can prevent the jaw 192 from expanding outwardly and disengaging from the collar. Additionally, the undercuts in the ridges do not obstruct the collar facets 158, allowing other instruments, such as hemostats, to grasp the collar 154.

[0046] In one embodiment, as shown in FIG. 4D , the port body 122 can further include a gasket 132 annularly disposed around the port stem 124. For example, as shown in FIG. 4D , if the port 120 includes a dual-lumen port, the port 120 can include a first port stem 124A and a second port stem 124. Accordingly, the gasket 132 can be configured to extend annularly around each of the port stems 124A, 124B. The gasket 132 is disposed between the port body 122 and the catheter adapter 160 to provide a fluid-tight seal between the port body 122 and the catheter adapter 160 when the catheter adapter 160 is engaged with the port stem 124.

[0047] 4D , the cath lock body 152 can include a ring 134 extending radially inward from the inner wall of the cath lock lumen 156 and extending annularly about the longitudinal axis. The cath lock ring 134 can be configured to abut a shoulder 168 of the cath lock adapter 160, forcing the cath lock adapter 160 longitudinally proximally against the port stem 124 and, optionally, the gasket 134. Thus, the mechanical advantage utilized by the rotation of the collar can not only force the catheter 110 onto the cath lock adapter stem 164, but can also force the cath lock adapter 160 onto the port stem 124 and, optionally, the gasket 134. This can ensure a fluid-tight seal between the port 120 and the catheter 110, even under high-pressure infusion.

[0048] As shown in Figures 5A-5E, in embodiments, the cath lock adapter 160 can be coupled to the cath lock 150 to form a single functional unit. The cath lock adapter 160 can be coupled to the cath lock 150 by one of a press-fit engagement, an interference fit engagement, or a snap-fit ​​engagement. As shown in Figure 5A, the adapter instrument 184 of the insertion instrument 180 can extend through the proximal end of the cath lock lumen 156 such that the adapter protrusions 186 can engage with the cath lock adapter lumen 166 of the cath lock adapter body 162. The clinician can then use the insertion instrument 180 to manipulate the cath lock adapter 160, and also to manipulate the cath lock 150 coupled to the adapter 160, as described herein.

[0049] As shown in Figures 5B-5D, in an embodiment, the cath lock adapter 160 engages the cath lock 150 with a snap-fit ​​engagement. Figure 5B shows the cath lock adapter 160 with the tabs 146 extending from the cath lock adapter body 162. Figure 5C shows a close-up detail of the cath lock adapter 160 positioned within the lumen 156 of the cath lock body 152, with the tabs 146 engaged with the recesses 148. Figure 5D shows the assembly of the cath lock 150 and adapter 160, with the cath lock 150 shown in wire frame. An adapter device 184 is shown engaged with the lumen 166 of the adapter 160, and the catheter 110 is shown engaged with the adapter stem 164. FIG. 5E shows a cross-sectional view of the assembly of the catheter lock 150 and adapter 160, with the adapter device 184 engaged with the lumen 166 of the adapter 160, the catheter 110 engaged with the adapter stem 164, and the prongs 146 engaged with the recesses 148.

[0050] In one embodiment, the detents 146 can extend from the sides of the adaptor body 162. The detents 146 can include a relatively gently sloping distal face and a relatively steeply sloping proximal face, each extending from the sides of the cas lock adaptor body 162. In one embodiment, the proximal faces of the detents 146 can extend substantially perpendicular to the surface of the cas lock adaptor body 162.

[0051] The pawl 146 can be configured to engage a recess 148 disposed in the cath lock body 152. In one embodiment, the adapter 160 can be engaged with the cath lock 150, e.g., with an interference fit, to allow some longitudinal movement between the adapter 160 and the cath lock 150. In one embodiment, the adapter 160 can be separate from the cath lock 150 and can be disposed within the cath lock lumen 156 so as to be slidably engaged with the cath lock 150, as described herein.

[0052] In use, a clinician can slide the proximal end of the catheter 110 through the distal end of the cath lock lumen 156 and push the cath lock adapter stem 164 into the proximal end of the catheter lumen 112. When the proximal end of the catheter 110 is fully engaged with the cath lock adapter stem 164, the clinician can apply additional force to slide the cath lock adapter 160 relative to the cath lock body 152 so that the pawl 146 aligns with the recess 148. The distal surface of the pawl 146 can engage with the recess 148 in a snap-fit ​​engagement, and the engagement of the pawl 146 with the recess 148 can provide an audible or tactile indication, such as a "click." The pawl 146 can abut against the surface of the cath lock 150 to prevent any proximal movement of the adapter 160 relative to the cath lock 150. Optionally, a snap fit engagement can further lock the catheter 110 to the cathlock adapter stem 164 .

[0053] Advantageously, the assembly of the cath lock 150 and the adapter 160 may reduce the number of separate parts that a clinician must manipulate. Additionally, the movement of the cath lock adapter 160 relative to the cath lock body 152, and optionally the snap-fit ​​mechanism, may generate an audible "click" signal and / or a tactile signal to the clinician. The audible or tactile signal may indicate to the clinician that the proximal end of the catheter 110 is fully engaged with the cath lock adapter stem 164. The clinician may then withdraw the insertion tool 180 from the cath lock lumen 156. Because the insertion tool 180 is engaged with the adapter 160 with a light interference fit, the engagement between the adapter stem 164 and the catheter 110 allows the adapter 160 to disengage from the insertion tool 180 as the insertion tool 180 is withdrawn proximally. The interaction between the cath lock and the engaged pawl 146 may further prevent disengagement of either the adapter 160 or the cath lock 150 when the insertion tool 180 is withdrawn. With the cath lock adapter 160 and cath lock 150 assembly engaged with the catheter 110, the clinician may then engage the adapter 160 and cath lock 150 assembly with the port stem 120 as described herein.

[0054] In one embodiment, as shown in FIGS. 6A-6C , the cath lock adapter 160 can include a skirt 176 extending distally from the cath lock adapter body 162 and annularly around one or more cath lock adapter stems 164. FIG. 6A shows a side cross-sectional view of a catheter adapter 160 including a skirt 176 disposed within the lumen 156 of the cath lock 150. The skirt 176 can define an outer diameter that is approximately the same as or slightly smaller than the inner diameter (d2) of the proximal end of the cath lock lumen 156, but larger than the inner diameter (d1) of the distal end of the cath lock lumen 156. The skirt 176 can be formed from the same material as the cath lock adapter 160. In one embodiment, the skirt 176 can be formed from a different material than the cath lock adapter 160, exhibiting different mechanical properties. The skirt 176 can be sufficiently resilient to maintain its shape when compressed radially inward while still allowing some deflection or flexibility.

[0055] In one embodiment, as shown in FIGS. 6A and 6C, the skirt 176 can form a continuous annular structure extending about the longitudinal axis. In one embodiment, as shown in FIG. 6B, the skirt 176 can include one or more notches extending proximally from the distal end of the skirt 176 to form a plurality of “fingers” arranged annularly around one or more cath lock adapter stems 164. The notches can be configured to allow the fingers to flex radially inward and abut the outer surface of the catheter 110. The skirt 172 can be configured to compress a portion of the catheter 110 onto the adapter stem 164, reducing breakage or buckling of the catheter 110 when the cath lock 150 is tightened. In one embodiment, the catheter adapter 160, including the skirt 176, can be integrally formed with the port stem 124.

[0056] 6D-6E, the outer surface of the skirt 176, the cath lock adapter body 162, or both, can include threads 178 configured to engage with threads disposed on the inner surface of the cath lock lumen 156. In one embodiment, the outer surface of one of a portion of the port body 122 or a portion of the port stem 124 can also include threads configured to complement the threads 178 disposed on the outer surface of the skirt 176 or the adapter body 162 and to engage with threads disposed on the inner surface of the cath lock lumen 156. Rotation of the cath lock collar 154 or the cath lock body 152 can threadably engage one of the skirt 176, the cath lock adapter body 162, the port stem 124, or the port body 122. Advantageously, the threaded engagement between the cath lock 150 and the adapter 160 can provide a secure engagement and smooth longitudinal movement between the cath lock 150 and the adapter 160. This engagement can reduce the risk of the catheter 110 breaking or buckling when the cathlock 150 compresses a portion of the catheter 110 onto the adapter stem 164 .

[0057] In an exemplary method of use, the proximal end of the catheter 110 can engage the adapter stem 164, and the stem 164 extends into the catheter lumen 112 with an interference fit, as described herein. The catheter 110 can extend over the stem 164 until the proximal tip engages the adapter body 162. The skirt 176 can extend over the outer surface of the catheter 110. The adapter body 162 can then engage the port stem 124, and the cath lock 150 can be urged proximally onto the assembly of the catheter 110 and adapter 160. The distal portion of the adapter 160 can extend into the proximal portion of the cath lock lumen 156. In one embodiment, the cath lock collar 154 can engage the port 120 and rotate to urge the cath lock body 152 proximally using mechanical advantage.

[0058] In one embodiment, one of the collar 154 or the body 152 of the cath lock 150 can be rotated to threadingly engage the outer surface of one of the skirt 176, the adapter body 162, the port stem 124, or the port body 122, allowing the cath lock 150 to be urged proximally onto the assembly of the catheter 110 and the adapter 160. At least a portion of the cath lock lumen 156 tapers from diameter (d2) to diameter (d1). Thus, as the cath lock 150 is urged proximally, the wall of the cath lock lumen 156 presses radially inward against the skirt 176, sandwiching the catheter 110 between the inner surface of the skirt 176 and the outer surface of the catheter adapter stem 164. If the cath lock were to directly engage the catheter and be urged longitudinally proximally, frictional forces between the cath lock and the catheter could damage or buckle the catheter wall, disrupting the annular seal between the cath lock and the catheter and resulting in fluid leakage. Advantageously, the skirt 176 can reduce any longitudinal or rotational frictional forces between the caslock 150 and the catheter 110 while at the same time providing a radially inward clamping force, reducing any damage to the catheter 110.

[0059] In an exemplary method of use, the connection system 100 may be provided as described herein. In one embodiment, the catheter 110 may be placed within the patient's vasculature, and the proximal end of the catheter 110 may optionally be trimmed to length. The body of the cath lock 150 may be slidably engaged with the proximal end of the catheter 110, with the catheter 110 extending through the cath lock lumen 156. In one embodiment, the outer diameter of the catheter 110 may be approximately the same as or slightly smaller than the inner diameter (d1) of the distal end of the cath lock lumen 156 so that the cath lock 150 can slidably engage the catheter 110. In one embodiment, the cath lock 150 may frictionally engage the outer surface of the catheter 110 so that the clinician can place the cath lock 150 onto the catheter 110 and the cath lock 150 can remain in place without sliding along the catheter 110. Advantageously, the engagement between the cass lock body 152 and the catheter 110 may prevent the cass lock body 152 from sliding freely and sliding too far distally relative to the catheter 110 or sliding proximally off the catheter 110.

[0060] The clinician can then couple the adapter 160 to the adapter device 184 of the insertion tool 180. The clinician can then manipulate the insertion tool 180 to align the adapter 160 with the lumen 112 of the catheter 110 and push the adapter stem 164 into the catheter lumen 112, as described herein. Once the adapter 160 is securely engaged with the catheter lumen 112, the clinician can withdraw the insertion tool 180, thereby disengaging the adapter device 184 from the adapter 160 (FIG. 1B). Advantageously, the adapter stem 164 can expand the outer diameter of the proximal end of the catheter 110 to a diameter greater than the inner diameter (d1) of the distal end of the cath lock lumen 156. This prevents the cath lock body 152 from sliding proximally out of the proximal end of the catheter 110.

[0061] The clinician can then press the adapter body 162 onto the port stem 124. As described herein, the port stem 124 can engage with the adapter body 162 via an interference fit, press fit, snap fit, or Luer slip fit engagement (FIG. 1C). As shown in FIG. 1D, the cath lock 150 can be slid onto the adapter 160 and threadably engage with the port 120. For example, the collar 154 can engage with the port body 122 such that the protrusion 172 can engage with the helical groove 174, as described herein. The clinician can rotate the collar 154 to utilize mechanical advantage to press the cath lock 150 longitudinally proximally onto the adapter 160. In one embodiment, the clinician can engage the collar with a spanner head 190 of the insertion tool 180 to provide additional leverage and facilitate rotation of the collar.

[0062] As shown, the collar 154 includes a facet 158 ​​that engages a facet 194 on the jaw 192 of the wrench head 190. In one embodiment, the collar 154 may include multiple facets to allow the clinician to engage the collar 154 at various angles extending perpendicular to the longitudinal axis. The distal end of the cath lock lumen 156 may engage an outer surface of the catheter 110 proximate the distal end of the adapter stem 164 such that a portion of the catheter 110 may be compressed between the adapter stem 164 and the inner surface of the cath lock lumen 156. The cath lock 150 may thus ensure a fluid-tight seal between the catheter 110 and the port 120. Optionally, the cath lock 150 may compress a skirt 176 of the adapter 160 to compress a portion of the catheter 110, as described herein, to ensure a fluid-tight seal between the catheter 110 and the port 120.

[0063] Advantageously, because engagement can occur outside the access site, the adapter 160 can be pushed longitudinally onto the catheter 110 more easily than pushing the catheter 110 directly onto the port stem 124. The adapter 160 and catheter 110 assembly can then be engaged to the port 120 using the cath lock 150, allowing the clinician to use mechanical advantage to secure the adapter 160 / catheter 110 assembly to the port 120 using the cath lock 150.

[0064] In one embodiment, a fluid-tight seal is achieved between the catheter 110 and the adapter 160 by using the cath lock 150 to compress the catheter 110 onto the adapter stem 164. The compliant material of the catheter 110 can be slightly stretched to fit onto the adapter stem 164. The adapter stem 164 can radially expand the outer diameter of a portion of the catheter 110 to a diameter larger than the inner diameter (d1) of the cath lock lumen 156. This can grip the catheter 110 and form a fluid-tight seal as the cath lock 150 is forced longitudinally, compressing the catheter between the cath lock 150 and the stem adapter 160 (e.g., FIG. 4C ). Additionally, the adapter 160, which is a separate structure, can be attached to the catheter 110 outside of the tissue pocket before being coupled to the port 120, which may already be positioned within the tissue pocket and sutured in place. This allows the clinician to apply more leverage to push the adapter 160 onto the catheter 110 before coupling the adapter to the port 120, as described herein. Additionally, the locking teeth 142, 144 can indicate when sufficient torque has been applied to the casing lock to ensure a fluid-tight seal and can resist back-rotation that would loosen the casing lock. Additionally, the interaction of the pawl 146 and recess 144 can indicate when the catheter 110 is fully engaged with the adapter stem 164 to also ensure a fluid-tight seal.

[0065] 7A-8C, the connection system 200 can include a catheter 210 defining one or more lumens 212, a port 220 having a port stem 224, and a cathlock 250. In one embodiment, the port can include a port body 222 defining a reservoir 228 in fluid communication with the port stem 224. The port 220 can further include a needle-pierceable septum 226 disposed on the reservoir 228. However, it will be understood that the port 220 is exemplary and that other configurations of single-lumen or multi-lumen subcutaneous access devices are contemplated, as described herein.

[0066] In one embodiment, the port 220 can include a stem housing 230 that surrounds the port stem 224 about its axis. FIGS. 8D-8F show perspective views of the stem housing 230 surrounding the port stem 224. The outer surface of the stem housing 230 can include one or more facets or gripping features configured to facilitate a clinician's grip of the stem housing 230 using a hemostat or the like. In one embodiment, the port stem 224 can extend further from the port body 222 than the stem housing 230. In one embodiment, the stem housing 230 can extend further from the port body 222 than the port stem 224. In one embodiment, the port stem 224 and the stem housing 230 can extend equidistantly from the port body 222.

[0067] It will be appreciated that where the catheter 210 includes two or more lumens 212, the port 220 may include two or more port stems 224 extending from the port body 222, each surrounded by a stem housing 230. In one embodiment, each of the port stems 224 may communicate with a separate port reservoir 228. As used herein, a single-lumen catheter 210 and port 220 system is used for ease of explanation, however, it will be understood that multi-lumen catheter and port assemblies are also considered within the scope of the present invention.

[0068] The stem housing 230 can define an opening 232 defining an inner diameter sufficient to receive both a portion of the catheter 210 and a portion of the cath lock 250, as described in more detail herein. In one embodiment, the inner surface of the stem housing 230 can include threads configured to engage threads disposed on the cath lock 250. In one embodiment, the cath lock 250 can include a body 252 defining a lumen 256 extending along the longitudinal axis and configured to receive the catheter 210 therein. In one embodiment, the inner diameter of the cath lock lumen 265 can be the same as or slightly larger than the outer diameter of the catheter 210. In one embodiment, the cath lock lumen 256 can be a smooth lumen or include a low-friction surface or coating to reduce shearing of the catheter 210 during rotational engagement. In one embodiment, the outer surface of the catheter 210 may be provided with a lubricious coating or similar low-friction coating to reduce twisting or shearing of the catheter 210 when the cathlock 250 is tightened, as described in more detail herein.

[0069] In one embodiment, the cas lock 250 can include a collar 254 extending longitudinally from the cas lock body 252. The collar 254 can be configured to fit within the opening 232 of the stem housing 230. In one embodiment, the cas lock collar 254 can include threads configured to threadingly engage with the threads of the port stem housing 230. In one embodiment, the outer surface of the cas lock body 252 can include gripping features configured to facilitate rotation of the cas lock 250 about the longitudinal axis. Figure 7B shows an alternative embodiment of the cas lock 250 in which the cas lock collar 254 does not include threads and can engage with the stem housing 230 with an interference fit, press fit, snap fit, or luer slip fit engagement.

[0070] In one embodiment, the catheter lumen 212 can be configured to fit over the port stem 224, such as with an interference fit. In one embodiment, the port stem 224 can include a smooth outer surface or a low-friction surface or coating, as described herein, to reduce shearing of the catheter 210 during rotational engagement. In one embodiment, the port stem 224 can include a flared portion to provide increased compression of the catheter 210 and / or a more secure interference fit between the catheter 210 and the port stem 224. For example, the first portion 224A of the port stem 224 can define an outer diameter that is the same as or slightly smaller than the inner diameter of the catheter lumen 212. Thus, the catheter 210 can be forced over the first portion 224A of the port stem 224 with a relatively light interference fit. The second portion 224B, or “flared portion,” of the port stem 224 can define an increased outer diameter relative to the first portion 224A. The diameter of the second portion 224B can be larger than the inner diameter of the catheter lumen 212 to provide a relatively strong interference fit. In one embodiment, the port stem 224 can have a tapered transition between the first portion 224A and the second portion 224B.

[0071] In one embodiment, the cath lock lumen 256 can define a generally straight-walled lumen extending parallel to the longitudinal axis. In one embodiment, as shown in FIG. 7C , the first portion 256A of the cath lock lumen 256 can define a first diameter, and the second portion 256B of the cath lock lumen 256 can define a second diameter that is larger than the first diameter. The second portion 256B of the cath lock lumen 256 can align with the flared portion 224B of the port stem 224B. In one embodiment, the cath lock lumen 256 can include a tapered portion that provides a transition between the first portion 256A and the second portion 256B.

[0072] 8A-8C illustrate an exemplary method of use for coupling a catheter 210 to a port 220 using a cath lock 250 and stem housing 230. The port 220 is provided with a port stem 224 and stem housing 230 as described herein. Optionally, the proximal end of the catheter 210 can be trimmed to length. The catheter 210 can then be threaded through the lumen 256 of the cath lock 250, and the proximal end of the catheter 210 can engage with the port stem 224. As described herein, the catheter 210 can engage with the port stem 224, such as with an interference fit.

[0073] The cath lock 250 can then be slid over the catheter 210 toward the port 220 until the collar 254 engages the opening 232 in the stem housing 230. As the cath lock 250 is pushed into the stem housing opening 232, a proximal portion of the catheter 210 can be compressed between the cath lock 250 and the port stem 224. The cath lock 250 can engage the stem housing 230 with a Luer slip fitting engagement, securing the cath lock 250 and catheter to the port 220. In one embodiment, the cath lock 250 can be threadably engaged with the stem housing 230, using mechanical advantage to push the cath lock collar 254 into the stem housing 230 and secure the cath lock 250 to the stem housing 230.

[0074] In one embodiment, as the cath lock collar 254 is advanced over the catheter 210 disposed on the flared portion of the port stem 224, the flared portion of the port stem, i.e., the second portion 224B, can apply increased pressure to the catheter 210 between the port stem 224 and the cath lock 250. This results in increased pressure and an improved seal between the catheter 210 and the port 220. Advantageously, the cath lock 250 provides a secure connection between the catheter 210 and the port stem 224 while reducing leakage from the connection, even under high infusion pressures. Additionally, the cath lock 250 reduces breakage or shearing of the catheter 210 during the connection process.

[0075] 9A-9C illustrate an embodiment of a connection system 300 comprising a catheter 310 defining one or more lumens 312, a catheter lock 350, an adapter 360, and a port 320 having a port body 322 defining a port socket 324. The adapter 360 comprises an adapter body 362 defining a generally circular cross-sectional shape and an adapter stem 364 extending longitudinally from the adapter body 362. The adapter body 362 and the adapter stem 364 can define a lumen 366 that provides fluid communication between the catheter 310 and the port 320.

[0076] The adapter stem 364 can define an outer diameter that is approximately the same as or slightly larger than the inner diameter of the catheter lumen 312. Thus, the adapter stem 364 can be pressed into the catheter lumen 312 and engage with the catheter lumen 312 in an interference fit. In one embodiment, the adapter 360 can further include a skirt 376 extending longitudinally from the adapter body 362 and surrounding a portion of the adapter stem 364 about the longitudinal axis. The skirt 376 can be formed of a resilient material and can be flexibly deformed radially inward to compress a portion of the catheter 310 between the skirt 376 and the outer surface of the adapter stem 364. In one embodiment, the cath lock 350 can slidably engage the outer surface of the catheter 310 and compress the catheter 310 onto the adapter stem 364 to secure the catheter 310 to the adapter stem 364. In one embodiment, the cath lock 350 can compress the skirt 376 onto the catheter 310 and adapter stem 364 to secure the catheter 310 to the adapter stem 364 .

[0077] In one embodiment, the port 320 can include a socket 324 defining a recess configured to receive a portion of the adapter body 362 therein. The adapter body 362 can rotatably engage with the socket 324 to lock the adapter 360 in the socket 324 and provide fluid communication between the port 320 and the adapter lumen 366. In one embodiment, the adapter body 362 can threadably engage with the port socket 324. In one embodiment, the catheter body 362 can include one or more protrusions 372 configured to engage with helical grooves 374 disposed on the inner surface of the port socket 324. As the catheter body 362 is rotated, the protrusions 372 can engage with the helical grooves 374, forcing the adapter body 362 longitudinally into the port socket 324 until the adapter engagement surface 368 of the adapter body 362 engages the port engagement surface 328, providing fluid communication between the port 320 and the adapter 360 (FIG. 9C). In one embodiment, the outer surface of the adapter 360 can include facets 358 or similar gripping features configured to facilitate rotation of the adapter body 362 about the longitudinal axis. In one embodiment, the facets 358 can be configured to engage the wrench head 190 of the insertion tool 180 as described herein.

[0078] In an exemplary method of use, a clinician can place the catheter 310 within a patient's vasculature and position the distal tip of the catheter 310 at a target location. Optionally, the proximal end of the catheter 310 can be trimmed to an appropriate length. The clinician can then push the adapter 360 onto the proximal end of the catheter 310 by pushing the adapter stem 364 into the lumen 312 of the catheter 310 and engaging it with an interference fit.

[0079] In one embodiment, the clinician can then slide the cath locks 350 over the portions of the catheter 310 that engage these adapter stems 364, compressing the catheter 310 onto the adapter stem 364 to secure the catheter 310 to the adapter stem 364. In one embodiment, the adapter 360 can include a skirt 376. The proximal end of the catheter 310 can extend between the adapter stem 364 and the skirt 376. The cath locks 350 can then be slid over the skirt 376, compressing it radially inward to clamp the catheter 310 onto the adapter stem 364. Advantageously, the skirt 376 can prevent shearing or breaking of the catheter 310 when the cath locks 350 are tightened around the catheter 310, as described herein.

[0080] The clinician can then engage the adapter body 362 with the port socket 324 and rotate the adapter body 362 about the longitudinal axis to longitudinally press the adapter 360 into the port 320 and secure it thereto. In one embodiment, the protrusion 372 can engage the helical groove 374. As the adapter body 362 is rotated, the mechanical advantage of the protrusion 372 engaging the helical groove 374 forces the adapter 360 into the port 320. In one embodiment, the port 320 can include a gasket disposed between the adapter engagement surface 368 and the port engagement surface 328 to ensure a fluid-tight seal therebetween. In one embodiment, the clinician can use an insertion tool 180 to facilitate coupling the adapter 360 with the catheter 310 or rotating the adapter 360 into engagement with the port socket 324, as described herein.

[0081] Some specific embodiments are disclosed herein, and although the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and the broader aspects also encompass these adaptations and / or modifications. Thus, one can deviate from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein. The technical ideas included in the present disclosure are described below. (Appendix 1) 1. A connection system for a subcutaneous port comprising a port stem, the connection system comprising: an adapter comprising: an adapter body configured to connect to the port stem; and an adapter stem extending from the adapter body and configured to be inserted into a catheter lumen of a catheter to connect the adapter to the catheter; a cath lock having a cath lock lumen and configured to slide on an outer surface of the catheter, the cath lock having threads for engaging with the port stem, wherein engaging the cath lock with the port stem compresses the catheter radially inward onto the adapter. (Appendix 2) 2. The connection system of claim 1, wherein the adapter stem is configured to radially expand the catheter lumen to secure the adapter to the catheter with an interference fit. (Appendix 3) 3. The connection system of claim 1 or 2, wherein the adapter is formed from a resilient material. (Appendix 4) 4. The connection system of any one of claims 1 to 3, wherein the adapter body engages the port stem in one of an interference fit engagement, a press fit engagement, a snap fit engagement, or a luer slip fit engagement. (Appendix 5) 5. The connection system of any one of claims 1 to 4, wherein the adapter comprises a skirt extending longitudinally from the adapter body and annularly disposed around the adapter stem, the skirt configured to elastically deform radially inward to engage an outer surface of the catheter. (Appendix 6) 6. The connection system of claim 5, wherein the skirt is formed from a plurality of fingers extending longitudinally from the adapter body and arranged annularly around the adapter stem, the fingers being configured to elastically deform radially inward to engage the outer surface of the catheter. (Appendix 7) 7. The connection system of claim 6, wherein a tip of one of the fingers comprises a radially inward extending protrusion configured to engage a portion of the catheter. (Appendix 8) 8. The connection system of any one of claims 5 to 7, wherein an outer surface of the skirt comprises a threaded portion configured to threadingly engage the casing lock. (Appendix 9) 9. The connection system of claim 1, wherein the casing includes a casing body rotatably coupled to a collar, the collar including a protrusion configured to engage a helical groove disposed on the port, and wherein rotating the collar forces the protrusion through the helical groove and forces the casing longitudinally. (Appendix 10) 10. The connection system of claim 9, wherein an inner surface of the collar comprises collar locking teeth configured to engage port locking teeth disposed on the port and configured to provide an audible or tactile indication or prevent retrograde rotation of the collar. (Appendix 11) 11. The connection system of claim 10, wherein the casing body and collar define a casing lumen, the lumen diameter in the casing body having a first diameter and the lumen diameter in the collar defining a second diameter greater than the first diameter, and the casing lumen includes a tapered portion extending from the second diameter to the first diameter. (Appendix 12) 12. The connection system of claim 11, wherein the portion of the catheter disposed on the adapter stem defines an outer diameter greater than the first diameter of the catheter lumen and less than the second diameter of the catheter lumen. (Appendix 13) 13. The connection system of any one of claims 1 to 12, wherein the caslock lumen has a ring extending radially inward from its inner wall, the ring configured to abut a shoulder portion of the adapter. (Appendix 14) 14. The connection system of any one of claims 1 to 13, wherein the port includes a gasket disposed between the port and the adapter and surrounding the port stem. (Appendix 15) 15. The connection system of any one of claims 1-14, further comprising an insertion tool, the insertion tool having a handle, an adapter tool configured to engage a lumen of the adapter, or a wrench head configured to engage a collar of the caslock. (Appendix 16) 16. The connection system of claim 15, wherein the spanner head of the insertion instrument includes a jaw configured to engage a facet of the collar to facilitate rotation of the collar about a longitudinal axis. (Appendix 17) 17. The connection system of claim 16, wherein the jaw comprises a lip configured to engage an undercut in a collar ridge of the collar to facilitate rotation of the collar about the longitudinal axis. (Appendix 18) 18. The connection system of any one of claims 1 to 17, wherein the proximal end of the catheter is severable. (Appendix 19) 19. The connection system of any one of claims 1-18, wherein the adapter comprises a detent configured to engage a recess disposed in the catheter lock in a snap-fit ​​engagement to provide an audible or tactile signal that the catheter lumen is fully engaged with the adapter. (Appendix 20) 20. The connection system of any one of claims 1-19, wherein the port comprises a port locking tooth and the caslock comprises a caslock locking tooth extending from a surface of the caslock lumen, the port locking tooth being configured to engage the caslock locking tooth in a snap-fit ​​engagement to prevent retrograde rotation of the caslock. (Appendix 21) 1. A cathlock system for coupling a catheter to a port, the cathlock system comprising: a port comprising: a port stem; and a stem housing surrounding a portion of the port stem and defining an opening, the port stem including a flared portion; a caslock having a caslock body and a collar extending longitudinally from the caslock body, the collar configured to extend between an outer surface of the port stem and an inner surface of the opening in the stem housing; (Appendix 22) 22. The caslock system of claim 21, wherein the flared portion is disposed within the stem housing. (Appendix 23) 23. The caslock system of claim 21 or 22, wherein the caslock engages with the stem housing by one of a threaded engagement, a press fit engagement, an interference fit engagement, or a luer slip fit engagement. (Appendix 24) 24. The caslock system of any one of claims 21 to 23, wherein the caslock is configured to compress a portion of the catheter between the inner surface of the caslock lumen and the outer surface of the port stem. (Appendix 25) 25. The catheter lock system according to any one of claims 21 to 24, wherein the catheter is provided with a coating having a low coefficient of friction. (Appendix 26) 26. The cast lock system of any one of appendixes 21 to 25, wherein the port stem comprises a first portion defining a first outer diameter, a flared portion defining a second outer diameter larger than the first outer diameter, and a tapered portion transitioning between the first outer diameter and the second outer diameter. (Appendix 27) 27. The cathlock system of claim 26, wherein the first outer diameter is the same as or slightly smaller than the inner diameter of the lumen of the catheter in an unstressed state, and the second outer diameter is greater than the inner diameter of the lumen of the catheter in an unstressed state. (Appendix 28) 28. The caslock system of claim 26 or 27, wherein the lumen of the caslock body defines a first diameter and the lumen of the collar defines a second diameter larger than the first diameter, the first diameter configured to engage the first portion of the port stem and the second diameter configured to engage the flared portion of the port stem. (Appendix 29) 29. The cas lock system of any one of claims 21 to 28, wherein an outer surface of the cas lock comprises facets or gripping features configured to facilitate rotation of the cas lock about a longitudinal axis. (Appendix 30) 1. An adapter configured to couple a catheter to a port, the adapter comprising: an adapter body defining a circular cross-sectional shape, the adapter body including a protrusion disposed on an outer surface of the adapter body, the protrusion configured to engage a helical groove disposed on the port; an adapter stem extending longitudinally from the adapter body and configured to engage the lumen of the catheter with an interference fit. (Appendix 31) 31. The adapter of claim 30, further comprising a cast lock slidably engaged with an outer surface of the catheter, the cast lock configured to compress a portion of the catheter against the adapter stem. (Appendix 32) 32. The adapter of claim 30 or 31, further comprising a skirt extending longitudinally from the adapter body and surrounding the adapter stem, the skirt configured to engage an outer surface of the catheter and to resiliently deflect to compress a portion of the catheter against the adapter stem. (Appendix 33) 33. The adapter of claim 32, wherein the skirt comprises a plurality of fingers configured to elastically deflect to compress a portion of the catheter against the adapter stem. (Appendix 34) 34. The adapter of any one of appendixes 30 to 33, wherein the adapter body is configured to rotate to engage the protrusion with the spiral groove and urge the adapter body longitudinally. (Appendix 35) 35. The adapter of any one of appendixes 30 to 34, wherein the adapter body is configured to fit into a socket disposed within the port, and the spiral groove is disposed on an inner surface of the socket.

Claims

1. 1. A connection system for a subcutaneous port comprising a port stem, the connection system comprising: an adapter comprising: an adapter body configured to connect to the port stem; and an adapter stem extending from the adapter body and configured to be inserted into a catheter lumen of a catheter to connect the adapter to the catheter; a cath lock having a cath lock lumen and configured to slide over an outer surface of the catheter, the cath lock having threads for engaging the port stem, wherein engaging the cath lock with the port stem compresses the catheter radially inwardly onto the adapter; A connection system wherein the adapter comprises a skirt extending longitudinally from the adapter body and annularly disposed about the adapter stem, the skirt configured to elastically deform radially inwardly to engage an outer surface of the catheter.

2. The connection system of claim 1 , wherein the adapter stem is configured to radially expand the catheter lumen to secure the adapter to the catheter with an interference fit.

3. The connection system of claim 1 or 2, wherein the adapter is formed from a resilient material.

4. The connection system of any one of claims 1 to 3, wherein the adapter body engages the port stem in one of an interference fit engagement, a press fit engagement, a snap fit engagement, or a luer slip fit engagement.

5. 5. The connection system of claim 1, wherein the skirt is formed from a plurality of fingers extending longitudinally from the adapter body and arranged annularly around the adapter stem, the plurality of fingers being configured to elastically deform radially inwardly to engage an outer surface of the catheter.

6. The connection system of claim 5 , wherein a distal end of one of the fingers comprises a radially inwardly extending protrusion configured to engage a portion of the catheter.

7. The connection system of any one of claims 1 to 6, wherein an outer surface of the skirt comprises a threaded portion configured to threadingly engage the casing lock.

8. A connection system for a subcutaneous port having a port stem, the connection system comprising: an adapter comprising: an adapter body configured to connect to the port stem; and an adapter stem extending from the adapter body and configured to be inserted into a catheter lumen of a catheter to connect the adapter to the catheter; a cath lock having a cath lock lumen and configured to slide over an outer surface of the catheter, the cath lock having threads for engaging the port stem, wherein engaging the cath lock with the port stem compresses the catheter radially inwardly onto the adapter; The cass lock comprises a cass lock body rotatably coupled to a collar, the collar comprising a protrusion configured to engage a helical groove disposed on the port, and wherein rotating the collar urges the protrusion through the helical groove and urges the cass lock longitudinally.

9. 9. The connection system of claim 8, wherein an inner surface of the collar comprises collar locking teeth configured to engage port locking teeth disposed on the port and configured to provide an audible or tactile indication or prevent retrograde rotation of the collar.

10. 10. The connection system of claim 9, wherein the casslock body and collar define a casslock lumen, a lumen diameter in the casslock body having a first diameter and a lumen diameter in the collar defining a second diameter greater than the first diameter, and the casslock lumen includes a tapered portion from the second diameter to the first diameter.

11. 11. The connection system of claim 10, wherein the portion of the catheter disposed on the adapter stem defines an outer diameter greater than the first diameter of the cath lock lumen and less than the second diameter of the cath lock lumen.

12. 12. The connection system of claim 1, wherein the cathlock lumen includes a ring extending radially inwardly from an inner wall thereof, the ring configured to abut a shoulder of the adapter.

13. The connection system of any one of claims 1 to 12, wherein the port comprises a gasket disposed between the port and the adapter and surrounding the port stem.

14. 14. The connection system of claim 1, further comprising an insertion tool having a handle, an adapter tool configured to engage a lumen of the adapter, or a spanner head configured to engage a collar of the cath lock.

15. 15. The connection system of claim 14, wherein the spanner head of the insertion tool includes a jaw configured to engage a facet of the collar to facilitate rotation of the collar about the longitudinal axis.

16. 16. The connection system of claim 15, wherein the jaw comprises a lip configured to engage an undercut in a collar ridge of the collar to facilitate rotation of the collar about a longitudinal axis.

17. The connection system of any one of claims 1 to 16, wherein the proximal end of the catheter is cut away.

18. A connection system for a subcutaneous port having a port stem, the connection system comprising: an adapter comprising: an adapter body configured to connect to the port stem; and an adapter stem extending from the adapter body and configured to be inserted into a catheter lumen of a catheter to connect the adapter to the catheter; a cath lock having a cath lock lumen and configured to slide over an outer surface of the catheter, the cath lock having threads for engaging the port stem, wherein engaging the cath lock with the port stem compresses the catheter radially inwardly onto the adapter; The adapter includes a detent configured to engage a recess disposed in the cath lock in a snap-fit ​​engagement to provide an audible or tactile signal that the catheter lumen is fully engaged with the adapter.

19. A connection system for a subcutaneous port having a port stem, the connection system comprising: an adapter comprising: an adapter body configured to connect to the port stem; and an adapter stem extending from the adapter body and configured to be inserted into a catheter lumen of a catheter to connect the adapter to the catheter; a cath lock having a cath lock lumen and configured to slide over an outer surface of the catheter, the cath lock having threads for engaging the port stem, wherein engaging the cath lock with the port stem compresses the catheter radially inwardly onto the adapter; a port having a port locking tooth and a caslock having a caslock locking tooth extending from a surface of the caslock lumen, the port locking tooth being configured to engage the caslock locking tooth in a snap-fit ​​engagement to prevent retrograde rotation of the caslock.

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