A peelable cathlock device is configured to allow a catheter or a port to be able to be replaced independently of each other. The peelable cathlock includes a body defining a cylindrical shape and extending from a first end to a second end. The body defines a lumen providing fluid communication between the first end, which is configured to attach to the proximal end of a catheter, and the second end configured to attach to a port. The peelable cathlock includes a tear line extending along a portion of the body are configured to allow the body to separate along the tear line when a force is applied.

BACKGROUND

Catheter systems can include a catheter locking device (hereinafter, “cathlock”), which can fluidly couple various vascular access devices within the system, such as a catheter to a vascular access port. The cathlock can be selectively detachable to allow one of the catheter or the port to be exchanged independently of each other. For example, the catheter system can be placed subcutaneously in a chest area of a patient. Occasionally, the catheter portion of the system requires replacing, such as to clear a blockage. The catheter can be replaced in a procedure known as a catheter exchange. Some catheter systems do not allow the catheter to be detachable from the port, requiring the catheter and the port to be replaced simultaneously. This can be expensive, time consuming and detrimental to the patient. Disclosed herein are embodiments of a cathlock device, and method of use, that allow the catheter or the port to be replaced independently of each other.

SUMMARY

Disclosed herein is a peelable cathlock including, a body defining a cylindrical shape and extending from a first end to a second end, the body defining a lumen providing fluid communication between the first end and the second end, the first end is configured to attach to a proximal end of a catheter, and the second end is configured to attach to a port stem, and a tear line extending along a portion of the body and configured to allow the body to separate therealong when a force is applied.

In some embodiments, the tear line includes one of a score line, groove, laser cut line, perforation, a thinned portion of a wall of the body. In some embodiments, the peelable cathlock further includes, a frangible band extending along a portion of the body and defined by a first tear line and a second tear line. In some embodiments, the peelable cathlock further includes a pull tab coupled to one of the body or the frangible band, proximate one of the first end or the second end, and configured to allow a user to grasp the pull tab and urge the pull tab away from the body to separate the body along one of the first tear line or the second tear line. The frangible band extends in a helical shape about a longitudinal axis of the body.

In some embodiments, a first portion of the helical frangible band is disposed adjacent a second portion of the helical frangible band to form a portion of the body. The frangible band extends parallel to a longitudinal axis of the body between the first end and the second end. The first tear line extends from the first end to the second end and the second tear line extends along a portion of the body from one of the first end or the second end. The frangible band extends along a portion of the body at an angle relative to longitudinal axis. The cathlock includes one of a plastic, polymer, elastomer, polytetrafluoroethylene (PTFE), metal, or alloy material.

Also disclosed is a method of removing a cathlock from a catheter system including, providing a cathlock including a body defining a substantially cylindrical shape and extending from a first end to a second end, and a tear line extending along a portion of the body, the cathlock providing fluid communication between a port and a catheter, grasping a portion of the cathlock, urging the portion of the cathlock away from the catheter system, and separating cathlock along the tear line.

In some embodiments, the tear line includes one of a score line, groove, laser cut line, perforation, or a thinned portion of a wall of the body. In some embodiments, the method further includes a frangible band extending along a portion of the body and defined by a first tear line and a second tear line. Grasping a portion of the cathlock further includes grasping a pull tab coupled to one of the body or the frangible band, proximate one of the first end or the second end. The frangible band extends in a helical shape about a longitudinal axis of the body. A first portion of the helical frangible band is disposed adjacent a second portion of the helical frangible band to form a portion of the body. The frangible band extends parallel to a longitudinal axis of the body between the first end and the second end.

In some embodiments, the first tear line extends from the first end to the second end and the second tear line extends along a portion of the body from one of the first end or the second end. The frangible band extends along a portion of the body at an angle relative to longitudinal axis. The cathlock includes one of a plastic, polymer, elastomer, polytetrafluoroethylene (PTFE), metal, or alloy material.

DESCRIPTION

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.

As used herein, the term “tear line” includes a line of weakness configured to allow separate therealong and can include a score line, groove, laser cut line, perforation, a thinned portion, or similar structure to facilitate separation therealong. 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.

FIG.1illustrates a plan view of a catheter system50including a port100, a catheter200and a peelable cathlock (“cathlock”)300configured to connect the catheter200to the port100and provide fluid communication therebetween. In some embodiments, the peelable cathlock300includes a cathlock body (“body”)310defining a substantially cylindrical shape and extending from a first end302, disposed proximate the catheter200, to a second end304, disposed proximate the port100. The body310can define a lumen306extending from the first end302to the second end304. The first end302can be configured to attach to the catheter200, and the second end304can be configured to attach to the port100. In some embodiments, the body310includes a tear line340configured to allow the body310to separate therealong, as discussed in more detail herein.

In an embodiment, the proximal end202of the catheter200can engage the port stem110to provide fluid communication between one or more lumens of the port stem110and one or more lumens of the catheter200. It should be appreciated that although the port100is shown with two access openings, a port with a single access opening or more than two access openings could be used with the inventive cathlock300. The present invention is not limited by the configuration of the port100or the catheter200configured to connect to the port100as it can be configured to connect any port and catheter combination. Following engagement of the catheter200and port stem110, the cathlock300is disposed over both to secure the catheter200to the port100and inhibit disengagement of the catheter200from the port100, or inhibit leakage.

In an alternate embodiment, the cathlock300can define one or more lumen306, each cathlock lumen306configured to provide fluid communication between a lumen of the port stem110and a lumen of the catheter200. The port stem110can engage a second end304of the cathlock300to provide fluid communication between a lumen of the port stem110and a lumen306of the cathlock300. Further, the catheter200can engage a first end302of the cathlock300to provide fluid communication between a lumen306of the cathlock300and a lumen of the catheter200.

The peelable cathlock300can include a tear line340extending along a portion of the body310. The tear line340can provide a line of weakness configured to allow the body310to separate along an axis when a force is applied thereto. As shown inFIG.1, in an embodiment, the axis of the tear line340can extend longitudinally along the body310between a first end302and a second end304. In an embodiment, the axis of the tear line340can extend helically about the body310. However, other configurations are contemplated, as described herein. In an embodiment, the tear line340can include score line, groove, laser cut line, perforation, a thinned portion, or similar structure to facilitate separation therealong. It is important to note that in an intact configuration, the tear line340still provides a fluid tight seal to prevent any fluid, disposed within the cathlock lumen306from passing through the first tear line340A and second tear line340B.

In some embodiments, the catheter system50, including the cathlock300, the catheter200, and the port100, can be formed integrally during the manufacturing process. In other embodiments, the cathlock300, catheter200and port100can be manufactured separately and assembled before placement within a patient. In an embodiment, one or more of the cathlock300, catheter200or port100may be coupled to a catheter system50that is already disposed within the patient. In some embodiments, the catheter system50can be assembled by urging a proximal end202of the catheter200into the first end302of the cathlock body310. In some embodiments, the catheter system50can be assembled by urging a port stem110of a port100into the second end304of the cathlock body310. One of the catheter proximal end202or the port stem110can engage the cathlock300in an interference fit, press fit, snap fit, protrusion and recess, pinion and detent, barbed engagement, combinations thereof, or the like. In an embodiment, one of the catheter proximal end202or the port stem110can be coupled to the cathlock300by adhesive, ultrasonic welding, bonding, combinations thereof, or the like. In some embodiments, the cathlock300may be 3D printed or injection molded. In some embodiments, the cathlock300may be formed of a plastic, polymer, elastomer, polytetrafluoroethylene (PTFE), metal, alloy, combinations thereof, or the like.

In some embodiments, as illustrated inFIGS.2A-2H, the tear line340may include more than one tear lines that can be configured in a variety of ways to facilitate easier separation of the cathlock300into at least one piece. For example, in an embodiment as illustrated inFIG.2A, the cathlock body410can include a pull tab420configured to facilitate grasping the body410and separation of the body410along a tear line440, e.g. a first tear line440A and a second tear line440B. In an embodiment, the pull tab420is coupled to a portion of the body410. In an embodiment, the pull tab420is coupled to a frangible band430, which is defined by the first tear line440A and the second tear line440B. The frangible band430is configured to separate from the body410of the cathlock400along the first tear line440A and the second tear line440B. In an embodiment, adjacent portions of the frangible band430can be coupled together in a helical shape to define the cathlock body410. A force can be applied to the pull tab420, which is coupled to the frangible band430at a first end402of the cathlock body410, and can unwrap the frangible band430in a helical manner. This allows the cathlock400to be separated from the catheter200and the port100. In an embodiment, the pull tab420can be coupled to the frangible band430at a second end404of the cathlock body410.

In some embodiments, the pull tab420can be substantially rectangular shaped. However, it will be appreciated that the pull tab420can be of various shapes such as oval, square, trapezoid, or the like. In some embodiments, the pull tab420can be textured to provide improved frictional interaction with a grasping medical device, such as forceps, hemostats, or the like. In some embodiments, the pull tab420can be coupled to a portion of the peelable cathlock400(e.g.FIG.2D) and can facilitate separation of the cathlock400along the first tear line440A, the second tear line440B or both. In embodiments, the pull tab420can be disposed proximate a first end402, proximate a second end404, or at a point disposed therebetween.

As shown inFIG.2B, in an embodiment, the frangible band530of the cathlock500can wrap around the cathlock body510in a spiral, or helical configuration. In this configuration, adjacent portions of the helical frangible band530can include portions of the catheter body510interposed therebetween. The frangible band510, defined by the first tear line540A and the second tear line540B can be separated from the cathlock body510by applying a force on the pull tab520which is coupled to the frangible band530at a first end502of the cathlock body510. The frangible band530can separate from the cathlock body510, allowing the cathlock500to be detached from one of the catheter200or the port100. In some embodiments, the pull tab520can be coupled to the frangible band530at the second end504of the cathlock body510.

FIG.2Cillustrates an embodiment, including a frangible band630, defined by a first tear line640A and a second tear line640B, extending substantially parallel to a longitudinal axis. One of the frangible band630, first tear line640A or second tear line640B can extend from the second end604of the cathlock body610to the first end602of the body610with the pull tab620coupled to the second end604of frangible band630. In this configuration, a force applied to the pull tab620can separate the frangible band630from the body610at a second end604, and can continue to separate along one of the tear lines640A,640B moving towards the first end602. This can separate the cathlock600into the frangible band630and the cathlock body610. In some embodiments, the pull tab620may be coupled to the first end of the frangible band630and the separation may start at the first end and move towards the second end602.

FIG.2Dillustrates and embodiment, including a cathlock700with a shortened frangible band730. The cathlock700can include a pull tab720coupled to a second end704of the frangible band730, as defined by a first tear line740A and a second tear line740B. The first tear line740A can extend from the second end704to the first end702. The second tear line740B can extend from the second end704to a point disposed between the second end704and the first end702. As such, a portion of the frangible band730can remain connected to the cathlock body710, even after the first tear line740A and second tear line740B are separated. Advantageously, the frangible band730and the cathlock body710can be removed as one piece.

FIG.2Eillustrates a cathlock800with a shortened frangible band830. In this embodiment, the cathlock800includes a pull tab820coupled to a second end804of the frangible band830, as defined by a first tear line840A and a second tear line840B. In an embodiment, the second tear line840B intersects the first tear line840A at a point disposed between the first end802and the second end804, to define a distal end of the frangible band830. This allows for the frangible band830to separate from the cathlock body810after the first tear line840A and second tear line840B are separated. Further this allows one end of the cathlock800, e.g. the second end804to separate from the port100while the opposite end, e.g. the first end802remains attached to the catheter200. Advantageously, this allows the cathlock body810to be removed along with the catheter200. In an embodiment, the frangible band830can extend from the first end802of the body810and allow the cathlock800to separate from catheter200while remaining attached to the port100.

In some embodiments, the cathlock may include more than one frangible band and more than one pull tab.FIG.2Fillustrates an embodiment of a cathlock900that includes a first pull tab920coupled to a first frangible band930and a second pull tab922coupled to a second frangible band932, each at second end904of the cathlock body910. The first frangible band930is defined by a first tear line940A and a second tear line940B. The second frangible band932is defined by a third tear line944A and a fourth tear line944B. In this embodiment, the first frangible band930and the second frangible band932wrap around the cathlock body910in a mirrored configuration. In some embodiments, the first pull tab920can be coupled to the first frangible band930and the second pull tab922can be coupled to the second frangible band932at the first end902of the cathlock body910. In some embodiments, the first pull tab920can be coupled to the first frangible band930at the first end902or the second end904, and the second pull tab922can be coupled to the second frangible band932at the second end904or the first end902of the cathlock body910. In the embodiment illustrated inFIG.2F, a force applied to one of the first pull tab920, or the second pull tab922, either simultaneously or sequentially, can separate the cathlock body910into two or more pieces.

FIG.2Gillustrates a cathlock1000that includes a frangible band1030, a first tear line1040A, and a second tear line1040B, extending at an angle relative to the longitudinal axis. The cathlock1000can further include a pull tab1020coupled to the frangible band1030at the second end1004of the cathlock body1010proximate a first lateral side. A distal end of the frangible band1030can be disposed proximate the first end1002, and proximate a second lateral side, opposite the first lateral side. In some embodiments, the pull tab1020can be coupled to the frangible band1030at the first end1002of the cathlock body1010.FIG.2Hillustrates an embodiment of a cathlock1100wherein the frangible band1130, extends in a non-linear shape along the cathlock body1110, with a pull tab1120coupled to the frangible band1130at the first end1102. In some embodiments, the pull tab1120may be coupled to the second end1104of the cathlock body1110. In an embodiment, the first tear line1140A and the second tear line1140B can extend parallel to each other along either a linear path or a non-linear path. In an embodiment, the first tear line1140A and the second tear line1140B can extend along non-parallel, linear or non-linear paths, relative to each other.

The configurations of the tear lines and frangible bands inFIGS.2A-2Hare only exemplary and various configurations are contemplated. Furthermore, configurations of tear lines and frangible bands inFIGS.2A-2Hare not to be taken as limiting in any way.

FIGS.3A-3Billustrates a cross section of the cathlock body310ofFIG.1including a tear line340. In an embodiment, the tear line340can include a groove, or thinned portion extending partially through a wall thickness (y) of the catheter body310. As shown inFIG.3A, in an embodiment the thinned portion of the tear line340can extend continuously from a proximal end to a distal end. As shown inFIG.3B, in some embodiments, the tear line340includes a plurality of indentations360extending partially through a wall thickness (y) of the cathlock body310. The plurality of indentations360can extend along a portion of the tear line340. One or more indentations of the plurality of indentations360can extend at the same length (x) or at different lengths (x). Similarly, one or more indentations of the plurality of indentations360can be spaced at the same distance (d) or at different distances (c). In an embodiment, the tear line340may include a perforation362that extends entirely through a wall thickness (y) of the catheter body310. In an embodiment, the tear line340may include indentation360that extend at different depths through the wall thickness (y). It is important to note that while the tear line340provides a line of weakness, the tear line340does not compromise the integrity of the fluid seal of the cathlock300. This maintains fluid communication through the lumen306of the cathlock300between the port100and the catheter200.

FIGS.4A-4Billustrate an exemplary method removing a peelable cathlock, in accordance with some embodiments. The cathlock600includes a body610including a first end602and a second end604. The cathlock600further includes a pull tab620coupled at the second end604to a frangible band630. In an embodiment, one of the first tear line640A or the second tear line640B can extend partially along a portion of the body610allowing a portion of the frangible band630to remain attached to the body610. For example, as illustrated inFIG.4B, a first tear line640A extends partially along a portion of the body610and a second tear line640B extends from the first end602to a second end604. As a force is applied to the pull tab620, the frangible band630can separate from the body610along one of the first tear line640A and second tear line640B. In some embodiments, the cathlock body610retains its shape until the frangible band630is completely removed from the cathlock600. Since the first tear line640A does not extend to the first end602, a portion of the frangible band630remains attached to body610. A user can continue to pull on the tab620, to remove the frangible band630and the cathlock body610in one movement.

FIGS.5A-5Dillustrates an exemplary method of replacing a cathlock, for example the cathlock500ofFIG.2B, in accordance with some embodiments.FIG.5Aillustrates the catheter system50including a catheter200, a peelable cathlock300and a port100. The cathlock500can provide fluid communication between the catheter200and the port100. The cathlock500can include a cathlock body510, defining a first end502and a second end504, a frangible band530defined by a first tear line540A and a second tear line540B, and a pull tab520coupled to the frangible band530at the first end502of the cathlock body510. In an embodiment, the frangible band630can extend helically about the body510and adjacent portions of the helical frangible band530can include portions of the catheter body510interposed therebetween.

In an embodiment, one of the port100or the catheter200can be exchanged independently of each other by separating the catheter200from the port100by detaching the cathlock300. As illustrated inFIG.5B, a grasping medical device1200, such as forceps, hemostats, or the like, can isolate and grasp the pull tab520. The pull tab520can then be urged away from the catheter system50, which can cause the frangible band530to separate from one of the cathlock body510, or an adjacent portion of the frangible band530that form the cathlock body510, along one of the first tear line540A or the second tear line540B.

In an embodiment, the cathlock500can be rotatably engaged with one of the port100or the catheter200about the longitudinal axis. As the frangible band530begins to separate from the cathlock body510, the body510can rotate about the longitudinal axis allowing the cathlock body to unravel, as illustrated inFIG.5C.

As noted, in an embodiment, the cathlock body510includes adjacent portions of the helical frangible band530interposed between the cathlock body510. As such unraveling the frangible band530in this manner separates the frangible band530from the cathlock500. The user can remove the cathlock500from the catheter system50allowing one of the port100or the catheter200to be exchanged. In some embodiments, when the pull tab520is coupled to the frangible band530at the first end502of the cathlock body510, the unraveling of the frangible band530releases the catheter200, while still being attached to the port100. In some embodiments, when the pull tab520is coupled to the frangible band530at the second end504of the cathlock body510, the unraveling of the frangible band530releases the port100, while still being attached to the catheter200.

FIG.5Dillustrates the complete unraveling of the frangible band530from the cathlock body510, separating the catheter200from the port100. The frangible band530can be removed and discarded, the user can then grasp and remove the cathlock body510. One of the port100or the catheter200can then be exchanged.

FIG.6illustrates a block diagram of the method1300ofFIGS.5A-5D. The first step (block1302) includes locating the pull tab520coupled to the frangible band530on the cathlock500with a grasping medical device1200including forceps or hemostats, or the like. In some embodiments, the pull tab520can be located at a first end502, a second end504of the cathlock body510or at a point therebetween. The second step (block1304) includes pulling the pull tab520with the grasping medical device1200to separate the cathlock body510along at first tear line540A and second tear line540B to unwrap the cathlock500. The third step (block1306) includes separating the frangible band530to disconnect the cathlock500from the catheter200and the port100. In some embodiments, the first tear line540A and second tear line540B separate in a clockwise or counterclockwise manner. In some embodiments, unraveling the cathlock500includes separating the frangible band530from the first end502to the second end504or from the second end504to the first end502.

In some embodiments, unraveling the cathlock500includes unraveling only the frangible band530while the cathlock body510remains substantially stationary relative to the catheter200and the port100. In some embodiments, unraveling the cathlock500includes the cathlock500rotating about the longitudinal axis as the frangible band530is unraveled helically. The fourth step (block1308) includes removing the peelable cathlock500and one of the catheter200or the port100from the port pocket. In some embodiments, removing the peelable cathlock500includes removing the cathlock500as a single piece. In some embodiments, the removing the peelable cathlock500includes removing the cathlock500in two or more pieces.