When placing catheters, e.g. Central Vascular Catheters (CVC) or Peripherally Inserted Central Catheters (PICC), the exact location of the distal tip within the vasculature can be essential to the efficacy of the catheter system and the treatment administered. For example, if the distal tip is not inserted far enough, the efficacy of the treatment is reduced. If the distal tip is inserted too far, the distal tip can cause cardiac arrhythmia. Catheters that are formed integrally with the port require estimating the length of the catheter prior to placement. Errors in estimating catheter length can be highly detrimental to the patient.
Proximally trimmable catheter port systems allow the catheter portion to be placed prior to trimming the catheter to an appropriate length. This can result in more accuracy in sizing the catheter relative to the target location and the port. Further, such port/catheter systems allow for the replacement of one of the port portion or the catheter portion without disturbing the positioning of the other portion. However, the catheter must then be attached to the port within the tissue pocket. Trimming the catheter and attaching the catheter to the port with a cathlock, all within the confined, wetted environment of a tissue pocket can be difficult. Such a process can require the manipulation of several tools to hold the catheter, hold the cathlock, trim the catheter, attach the catheter to the port, and finally lock the cathlock in place. This can lead to an increase risk of trauma to the insertion site due multiple tools being inserted at one time. Further repeated insertion of multiple tools can result in an increased risk of infection, and such a complex procedure can be time consuming.
Embodiments disclosed herein are directed to a cathlock placement and attachment tool for use with a proximally trimmable catheter and port systems. Advantageously, the tool provides a single tool configured to hold the catheter, hold the cathlock, trim the catheter, attach the catheter to the port, and lock the cathlock in place. This can mitigate repeated insertion of multiple tools and can expedite placing proximally trimmable port/catheter systems.
Disclosed herein is a stabilization and trimming tool for coupling a catheter to an access port including, a handle operatively coupled to a cradle and a clamping device, wherein the cradle is designed to hold a cathlock, and wherein the clamping device is designed to grip a catheter, and a catheter cutting mechanism coupled to the handle, wherein the catheter cutting mechanism is configured to be actuated following stabilization of the cathlock and the catheter by the handle.
In some embodiments, a first pressure applied to the handle applies pressure to the cradle, and wherein a second pressure greater than the first pressure applies pressure to both the cradle and the clamping device. The cradle defines a channel, an inner surface of the channel defines a profile that mirrors an outer profile of the cathlock. The inner surface of the channel defines a tapered shape. The inner surface of the channel defines a stepped portion configured to abut against a stepped portion of the cathlock. The clamping device includes a pair of clamping members covered by a rubber or silicone material. The catheter cutting mechanism is actuated by an actuator. The cradle includes a pair of jaws transitionable between an open position and a closed position, the jaws configured to retain the cathlock within the cradle in the closed position. A first jaw of the pair of jaws is rotatably coupled to a first edge of the cradle and a second jaw of the pair of jaws is rotatably coupled to a second edge of the cradle. The cradle defines a channel and includes a pair of grips transitionable between a retracted position and an extended position, the grips configured to retain the cathlock within the cradle in the extended position. The pair of grips are slidably engaged with the cradle along an axis extending perpendicular to an axis of the channel.
Also disclosed is a method of attaching a catheter to an access port including, creating a tissue pocket in a patient and inserting the access port into the pocket, the access port including a stem, inserting the catheter into a vessel of the patient until a tip of the catheter is positioned at a desired location, sliding a cathlock over a proximal end of the catheter, gripping the cathlock and the catheter with a tool, removing a proximal portion of the catheter using the tool, inserting the stem into an open end of the catheter, and sliding the cathlock over the catheter to secure the cathlock and the catheter to the access port.
In some embodiments, the tool comprises a handle operatively coupled to a cradle and a clamping device, wherein gripping the cathlock and the catheter comprises inserting the cathlock into the cradle, positioning the clamping device over the catheter, and actuating the handle to apply a gripping force to the cradle and the clamping device. The cradle defines a channel, an inner surface of the channel defines a profile that mirrors an outer profile of the cathlock. The inner surface of the channel defines a tapered shape. The inner surface of the channel defines a stepped portion configured to abut against a stepped portion of the cathlock. The tool further comprises a catheter cutting mechanism coupled to the handle, and wherein removing the proximal portion of the catheter comprises actuating the cutting mechanism after actuating the handle. The cutting mechanism includes a first cutting member rotatably coupled to the handle. The cutting mechanism includes a first cutting member and a second cutting member rotatably coupled to the handle in a scissor-like mechanism.
A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.
Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.
With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Likewise, a “proximal length” of, for example, the catheter includes a length of the catheter intended to be near the clinician when the catheter is used on the patient. A “proximal end” of, for example, the catheter includes an end of the catheter intended to be near the clinician when the catheter is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the catheter can include the proximal end of the catheter; however, the proximal portion, the proximal end portion, or the proximal length of the catheter need not include the proximal end of the catheter. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter is not a terminal portion or terminal length of the catheter.
With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a catheter disclosed herein includes a portion of the catheter intended to be near or in a patient when the catheter is used on the patient. Likewise, a “distal length” of, for example, the catheter includes a length of the catheter intended to be near or in the patient when the catheter is used on the patient. A “distal end” of, for example, the catheter includes an end of the catheter intended to be near or in the patient when the catheter is used on the patient. The distal portion, the distal end portion, or the distal length of the catheter can include the distal end of the catheter; however, the distal portion, the distal end portion, or the distal length of the catheter need not include the distal end of the catheter. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter is not a terminal portion or terminal length of the catheter.
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Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.
The present disclosure generally relates to a cathlock placement tool (“tool”) 100 configured to stabilize a cathlock 90 relative to a proximal portion of a catheter 80, and trim a portion of the catheter 80 to facilitate coupling with a port 70, securing the catheter thereto with a cathlock 90.
Proximally trimmable catheters and port systems are configured to allow placement of a distal portion of the catheter within a vasculature of the patient and couple an access port, or similar medical device, to a proximal end. Advantageously, a distal tip of the catheter can be placed at a target location prior to trimming the proximal end to a correct length and coupling to the port 70. This mitigates miscalculations of catheter length from sizing and coupling catheter and port systems prior to placement. Further, the proximal end of the catheter 80 can be trimmed to fit a location of the port 70 already disposed within a tissue pocket. This can be of particular relevance to port catheter systems where the catheter 80 can be detached and replaced, while the port 70 remains in place within the tissue pocket. Detachable port/catheter systems can include a cathlock 90, or similar device, configured to secure the catheter 80 to a stem of the port 70.
Embodiments, disclosed herein are directed to a tool 100 configured to stabilize a cathlock device (“cathlock”) 90 relative to a proximal portion of a catheter 80 and trim the proximal portion of the catheter 80 to a correct length for attachment to a subcutaneous access port (“port”) 70. Advantageously, embodiments disclosed herein provide a single tool for stabilizing the catheter, stabilizing the cathlock, trimming the catheter, attaching the catheter to the port, and locking the cathlock in place.
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An inner surface 126 of the channel 122 can define a profile that mirrors a profile of an outer surface of the cathlock 90, or portion thereof. As such a cathlock 90 can fit securely within the channel 122 to retain the cathlock 90 therein. In an embodiment, the inner surface 126 of the cradle can include a material or textured surface that can increase a friction coefficient between the cradle 120 and the cathlock 90, e.g. silicone, rubber, or the like. In an embodiment, the channel 122 can define a tapering inner surface 126 configured to restrict movement of the cathlock 90 relative to the cradle 120 in a first direction along the channel axis 12.
In an embodiment, the cathlock 90, or portion thereof, can define a tapering shape including a decreasing diameter between a proximal end and a distal end. In an embodiment, the outer surface 92 of the cathlock 90 can define one or more stepped portions 94 to define an abutment configured to engage an abutment surface of the channel 122 to restrict movement of the cathlock 90 relative to the cradle 120. The stepped portion 94 can extend annularly about a portion of the cathlock 90, about the longitudinal axis. In an embodiment, the outer surface of the cathlock can include one or more protrusions (not shown) to define an abutment configured to engage an abutment surface, or recess, of the channel 122 to restrict movement of the cathlock 90 relative to the cradle 120.
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In an embodiment, the jaws 134 can be operatively coupled to an actuator 170 disposed proximate a first end 112 of the handle 110. The actuator 170 is configured to allow a user to transition the jaws 134 between the open position and the closed position, as described in more detail herein. In an embodiment the jaws 134 can include a rubber, silicone, or similar material to increase a friction coefficient between the jaws 134 and the cathlock 90 and facilitate retaining the cathlock 90 within the channel 122.
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In an embodiment, the grips 136 can be operatively coupled to an actuator 170 disposed proximate a proximal end of the handle 110. The actuator 170 is configured to allow a user to transition the grips 136 between an extended position and a retracted position, as described in more detail herein. In an embodiment the grips 136 can include a rubber, silicone, or similar material to increase a friction coefficient between the grips 136 and the cathlock 90 and to facilitate retaining the cathlock 90 within the channel 122.
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In an embodiment, the clamp 150 can include a first clamping member 150A and a second clamping member 150B. One of the first clamping member 150A or the second clamping member 150B can be rotatably coupled with the tool to transition the clamp 150 between the open position and the closed position. In an embodiment, the clamp 150 can be operatively coupled to an actuator 170 to allow a user to transition the clamp 150 between the open position and the closed position. In an embodiment, the clamp 150 can include a material or textured surface that can increase a friction coefficient between the clamp 150 and the catheter 80, e.g. silicone, rubber, or the like. In an embodiment, the clamp 150 can include a biasing member, e.g. spring or the like, configured to bias the clamp 150 towards one of the open position or the closed position.
It will be appreciated that various clamping mechanisms are contemplated to fall within the scope of the present invention including sliding members, slidably engaged with the tool 100, wire members configured to encircle and tighten around the catheter 80, compression members configured to compress the catheter against a portion of the tool 100, combinations thereof, or the like.
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In an embodiment, the cutting member 160 can include a biasing member, e.g. spring or the like, configured to bias the cutting member 160 towards one of the first position or the second position. For example, a biasing member can bias the cutting member 160 towards the first position and the user can actuate an actuator 170 to transition the cutting member 160 to the second position, cutting a portion of the catheter 80 extending across the cutting member 160. When a user releases the actuator 170, the biasing member can transition the cutting member 160 from the second position to the first position.
In an embodiment, a biasing member can bias the cutting member 160 towards the second position. The cutting member 160 can be retained in the first position by a trigger. A user can actuate an actuator 170 to release the trigger and allow the biasing member to transition the cutting member 160 from the first position to the second position. Optionally an actuator 170 can be configured to reset the cutting member 160 from the second position to the first position such that the trigger can retain the cutting member 160 in the first position.
It will be appreciated that various cutting mechanisms 160 are contemplated to fall within the scope of the present invention including sliding cutting members, slidably engaged with the tool 100, wire members configured to encircle and tighten around the catheter 80 to cut through a portion thereof, scissor-like cutting members rotatably coupled with the tool and configured rotate in opposite directions relative to each other, combinations thereof, or the like.
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In an embodiment, a first actuator 172 can be operatively coupled to one of the jaws 134 or the grips 136, and the clamping mechanism 150. For example, the first actuator 172 can be moved from a first position to a second position to actuate one of the jaws 134 or the grips 136, and can then be moved to a third position to actuate the clamping mechanism 150. A second actuator 174 can be operatively coupled to a cutting mechanism 160. Optionally, the tool 100 can include a finger loop 190 or similar structure configured to facilitate grasping and manipulating the tool 100.
As used herein “operatively coupled” can include gears, levers, mechanisms, biasing members, springs, electrical motors, wiring, switches, power sources or the like, configured to operate a mechanism. For example, an actuator 170 can include a lever rotatably coupled to a first end of an actuator arm (not shown), which is disposed within an interior of the handle 110. A second end of the arm, opposite the first end, can be coupled with one of the jaws 134, grips 136, clamping mechanism 150, cutting member 160, or combinations thereof. Actuating the actuator 170 can move the arm within the interior of the handle 110 to actuate one of the jaws 134, grips 136, clamping mechanism 150, cutting member 160, or combinations thereof, as described herein, e.g. transition the jaws between open and closed, or the grips between extended and retracted, etc. In an embodiment, an actuator 170 can include a switch configured to close an electrical circuit to actuate a motor, servomechanism, or similar device. The motor can be disposed within an interior of the handle 110 and configured to actuate one of the jaws 134, grips 136, clamping mechanism 150, cutting member 160, or combinations thereof as described herein, e.g. transition the jaws between open and closed, or the grips between extended and retracted, etc.
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The user can then actuate an actuator 170 to actuate a cutting mechanism 160 to trim the proximal portion of the catheter 80 to a correct length. For example, a user can actuate a second actuator 174 to actuate a cutting mechanism 160 to trim the proximal portion of the catheter 80 to a correct length. Advantageously, since the cathlock 90 is engaged with the tool 100, if the cathlock 90 is correctly positioned relative to the catheter 80 and the catheter 80 is then stabilized relative to the cathlock 90 by the gripping mechanism 150, the cutting member 160 will be correctly positioned to trim the proximal portion of the catheter 80 to the correct length.
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While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.
Filing Document | Filing Date | Country | Kind |
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PCT/US20/49874 | 9/9/2020 | WO |