Multifunctional adapter for vascular access device placement

Abstract

[0003] The embodiments disclosed herein relate to a multi-function adapter system for positioning a distal tip of a catheter at a target location. The system is configured to maintain one or more electrical communication paths with the catheter distal tip during the positioning procedure. The two or more electrical paths may be cross-referenced to determine accuracy. The electrical paths may include a clip and a first tether, which provide a versatile electrical path in that the clip may be selectively coupled to either a saline column, a stylet, a guidewire, or a needle. The flushing adapter may include a second tether integrally formed with the flushing adapter to provide a second electrical path together with the saline column. A stylet or guidewire may be fixedly coupled with the flushing adapter to provide a second electrical path together with the second tether. These electrical paths may provide a fail-safe system to ensure electrical communication with the distal tip of the catheter.

Description

[Technical Field]

[0001] The present disclosure relates to a multi-function adapter for vascular access device placement. [Background technology]

[0002] Briefly summarized, embodiments disclosed herein relate to a multifunctional tip confirmation adapter system for positioning the distal tip of a catheter or similar vascular access device ("VAD") at a target location. Various multimodal vascular access placement systems can be used to locate, track, and confirm the placement of a catheter or similar VAD at a target location within a patient. Catheter distal tip placement can be important to the effectiveness of treatment and to prevent undue trauma to the patient. For example, when placing a catheter within the superior vena cava ("SVC"), if the distal tip of a central venous catheter ("CVC") does not reach the target area, the effectiveness of medication administration is reduced. If the distal tip is advanced too far, the distal tip can cause arrhythmia. Multimodal vascular access device placement systems can use various modalities to image the target area, track the catheter to the target area, and confirm the accuracy of catheter distal tip placement. Embodiments disclosed herein include a multi-function adapter configured to maintain one or more electrical communication paths with the distal tip of the catheter during a placement procedure to confirm placement of the distal tip of the catheter. Summary of the Invention

[0003] Disclosed herein is a catheter tip verification system comprising: a catheter adapter having a housing with a first cannula defining a lumen, the first cannula formed from a conductive material, a distal end of the catheter adapter housing configured to engage a proximal end of the catheter to provide fluid communication with the first cannula; a clip coupled to the first tether, the clip engaged with a socket disposed in the catheter adapter housing to releasably engage the first cannula, the clip configured to receive a first ECG signal; and a clip releasably coupled to the proximal end of the catheter adapter housing and configured to dispense a saline solution into the first cannula and into the catheter. the flushing adapter configured to provide a flushing column, the flushing adapter comprising a second tether fixedly coupled to the flushing adapter and configured to receive a second ECG signal; and an elongated medical device extending through the lumen of the first cannula, a distal tip of the elongated medical device extending to the distal tip of the catheter, the elongated medical device comprising a magnet disposed at the distal tip of the elongated medical device.

[0004] In some embodiments, the second tether is coupled to the elongate medical device to receive a second ECG signal from the distal tip of the elongate medical device. In some embodiments, the elongate medical device includes one of a stylet, a guidewire, or a coil-over-core guidewire. In some embodiments, the second tether is coupled to a second cannula that defines a lumen of the flushing adapter and is in fluid communication with the first cannula, the second tether being configured to receive a second ECG signal from a column of saline extending to the distal tip of the catheter. In some embodiments, a clip is selectively detachable from the first cannula and coupled to a proximal portion of the elongate medical device to receive a first ECG signal from the distal tip of the elongate medical device.

[0005] In some embodiments, the elongate medical device is fixedly coupled to the flushing adapter. In some embodiments, the flushing adapter further comprises a flushing arm configured to provide fluid communication with the flushing adapter. In some embodiments, the flushing adapter further comprises a locking valve configured to transition between a locked position and an unlocked position, the locking valve in the locked position configured to prevent longitudinal movement of the elongate medical device relative to the flushing adapter. In some embodiments, the locking valve further comprises a valve member configured to control fluid flow through the valve member in both the locked and unlocked positions.

[0006] In some embodiments, the catheter tip verification system further comprises a console configured to compare one of the first ECG signal and the second ECG signal to determine accuracy of the position of the distal tip of the catheter. In some embodiments, the console is further configured to detect a magnetic field at the distal tip of the elongate medical device and determine the position of the distal tip of the catheter within the patient. In some embodiments, the first cannula is formed from a metal, alloy, or conductive material. In some embodiments, the catheter comprises one of a central venous catheter, a peripherally inserted central catheter, a rapid insertion central catheter, a midline catheter, a single lumen catheter, a multi-lumen catheter, or a dialysis catheter.

[0007] Also disclosed is a method for determining the position of a distal tip of a catheter within a patient's body, the method including: coupling a multi-function adapter system to a proximal end of the catheter, the multi-function adapter system including a catheter adapter having a first cannula formed from a conductive material and in fluid communication with the catheter, a flushing adapter coupled to the proximal end of the catheter adapter, and a clip coupled to a first tether; establishing a saline plume within the first cannula and within the catheter; extending an elongated medical device through the first cannula and into a lumen of the catheter; receiving a first ECG signal by one of the saline plume or the elongated medical device; receiving a second ECG signal by one of the saline plume or the elongated medical device, the second ECG signal being different from the first ECG signal; and determining the position of the distal tip of the catheter using one or both of the first ECG signal and the second ECG signal.

[0008] In some embodiments, the method further includes comparing the first ECG signal with the second ECG signal to determine accuracy of the position of the distal tip of the catheter. In some embodiments, the method further includes engaging a clip with a slot disposed in the catheter adapter housing to contact the first cannula and receive the first ECG signal. In some embodiments, the method further includes engaging the clip with the elongate medical device to receive the first ECG signal. In some embodiments, the flushing adapter comprises a second cannula in fluid communication with the first cannula and a second tether fixedly coupled to the flushing adapter and configured to receive the second ECG signal.

[0009] In some embodiments, the flushing adapter includes a second tether fixedly coupled to the elongate medical device, the second tether configured to receive a second ECG signal. In some embodiments, the method further includes detecting a magnetic field strength of a magnet disposed at a distal tip of the elongate medical device to track a position of the distal tip of the catheter within the patient. In some embodiments, the elongate medical device includes one of a stylet, a guidewire, or a guidewire with a coil on a core.

[0010] In some embodiments, the method further includes disconnecting the catheter adapter from the catheter, coupling a subcutaneous access device to the catheter, accessing the subcutaneous access device with the access needle, and coupling a clip with the access needle to receive the first ECG signal. In some embodiments, the catheter includes one of a central venous catheter, a peripherally inserted central catheter, a rapid-insertion central catheter, a midline catheter, a single-lumen catheter, a multi-lumen catheter, or a dialysis catheter.

[0011] 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 therefore should not be considered as limiting 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]

[0012] [Figure 1A] FIG. 1 illustrates an exemplary multi-function adapter system in an assembled configuration, according to embodiments disclosed herein. [Figure 1B] 1B is an exploded view of the multi-function adapter system of FIG. 1A according to an embodiment disclosed herein. [Figure 2A] 1 is a cross-sectional view of a multi-function adapter system according to an embodiment disclosed herein. [Figure 2B] 1 is a cross-sectional view of a multi-function adapter system according to an embodiment disclosed herein. [Figure 2C] 1 is a cross-sectional view of a multi-function adapter system with a fixedly coupled stylet according to an embodiment disclosed herein. [Figure 2D] 1 is a cross-sectional view of a multi-function adapter system with a guidewire according to an embodiment disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0013] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein, and it should also be understood that certain 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 several embodiments disclosed herein.

[0014] With regard to the terms used herein, it should also be understood that the 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 impose sequential 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," "back," etc. are used for convenience and are not intended to imply, for example, a specific fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one," "one," and "the" also include plural references unless the context clearly dictates otherwise.

[0015] With respect to "proximal," for example, the "proximal portion" or "proximal end portion" of a catheter disclosed herein includes 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, but 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.

[0016] With respect to "distal," for example, the "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, the "distal length" of a catheter includes a length of the catheter intended to be near or within a patient when the catheter is used with a patient. For example, the "distal end" of a catheter includes an end of the catheter intended to be near or within a patient when the catheter is used with a patient. Although the distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, 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.

[0017] In the following description, the terms "or" and "and / or" as used herein should be construed as inclusive or meaning either one or any combination. As an example, "A, B, or C" or "A, B, and / or C" means "any of the following: A, B, C, A and B, A and C, B and C, A, B, and C." Exceptions to this definition would occur only if combinations of elements, components, functions, steps, or actions are essentially mutually exclusive in some respect. To aid in describing the embodiments described herein, as shown in FIG. 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.

[0018] 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. 1A-1B illustrate an exemplary multi-function adapter system ("system") 100 for catheter tip confirmation, which generally includes a catheter adapter system ("catheter adapter") 110, a flushing adapter system ("flushing adapter") 130, and an elongated medical device, such as a stylet 150 or a guidewire 250. FIG. 1A illustrates the system 100 in an assembled configuration. FIG. 1B illustrates an exploded view of the system 100 of FIG. 1A. In one embodiment, the distal end of the flushing adapter 130 can be coupled to the proximal end of the catheter adapter 110, providing fluid communication therebetween. The flushing adapter 130 can be coupled to the catheter adapter 110 using a connector 108. The exemplary connector 108 can comprise a Luer lock, a twist lock, a Tuohy-Borst connector, or a similar suitable medical fluid coupling mechanism. In one embodiment, the connector 108 can include a valve member 106 or similar structure configured to control the flow of fluid therethrough in either a connected state, a disconnected state, or both. In one embodiment, the catheter adapter 110 can be integrally formed with the flushing adapter 130.

[0019] In one embodiment, the distal end of the catheter adapter 110 can be coupled to the proximal end of a catheter 160 or similar VAD to provide fluid communication therebetween. The catheter adapter 110 can be coupled to the catheter 160 using a luer lock, twist lock, interference fit, press fit, snap fit engagement, or similar suitable coupling mechanism. In one embodiment, a cathlock device can further secure the catheter 160 to the catheter adapter 110. As used herein, an exemplary catheter 160 or similar VAD can include, but is not limited to, a central venous catheter (CVC), a peripherally inserted central catheter (PICC), a rapidly insertable central catheter (RICC), a midline catheter, a single-lumen or multi-lumen catheter, a dialysis catheter, etc. In one embodiment, the stylet 150 may be configured to extend through the lumen of one or more of the catheter adapter 110, the flushing adapter 130, and the catheter 160, as described in more detail herein.

[0020] In one embodiment, system 100 may further include a clip 170 coupled to a first tether 172, wherein clip 170 is configured to provide electrical communication between clip 170 and first tether 172. In one embodiment, clip 170 may be selectively coupled to one of catheter adapter 110, flushing adapter 130, stylet 150, or catheter 160. First tether 172 may be coupled to multimodal tracking system 80.

[0021] For example, the first tether 172 can include a first fin connector 174 disposed at a proximal end of the first tether 172 and configured to engage the sensor 90 of the multimodal tracking system 80. Thus, the clip 170, the first tether 172, and the fin connector 174 can be configured to provide an electrical communication path between the multimodal tracking system 80 and one of the catheter adapter 110, the flushing adapter 130, the stylet 150, or the catheter 160, as described herein. It will be appreciated that the fin connector 174 is an exemplary electrical connector and other electrical connector systems are considered within the scope of the present invention.

[0022] In one embodiment, the flushing adapter 130 can include a second tether 176 integrally formed therewith and configured to provide a second electrical pathway between the flushing adapter 130 and the sensor 90. In one embodiment, the second tether 176 can include a second fin connector 178 disposed at a proximal end of the second tether 176 and configured to communicatively couple the flushing adapter 130 to the multimodal tracking system 80, as described herein. In one embodiment, the first tether 172 and the second tether 176 can be coupled to different fin connectors, e.g., the first fin connector 174 and the second fin connector 178, respectively. In one embodiment, the first tether 172 and the second tether 176 can be coupled to the same fin connector. In one embodiment, one or both of the first tether 172 and the second tether 176 can be directly coupled to the console of the multimodal tracking system 80.

[0023] In one embodiment, the flushing adapter 130 can include a locking valve 136 disposed at a proximal end of the flushing adapter 130 and configured to selectively control fluid communication with the lumen of the flushing adapter 130. The locking valve 136 can include a Touhy-Borst connector, a Luer lock connector, or a similar mechanism configured to selectively provide fluid communication with the lumen of the flushing adapter 130. For example, the locking valve 136 can include a collar that can be rotated between a locked position and an unlocked position. In the unlocked position, a stylet 150 or a guidewire 250 can be advanced through the locking valve 136 and into the lumen of the flushing adapter 130. In the locked position, the locking valve 136 prevents the stylet 150 or guidewire 250 from moving through the locking valve 136, and may lock the position of either the stylet 150 or guidewire 250 relative to the flushing adapter 130, or may prevent the stylet 150 or guidewire 250 from entering the lumen of the flushing adapter 130. In one embodiment, the locking valve 136 may further comprise a valve member 106, such as a bileaflet valve, a slit valve, a duckbill valve, or the like, configured to control fluid flow through the locking valve 136 in one or both of the locked and unlocked positions. In one embodiment, the flushing adapter 130 may comprise a flushing arm 140 extending from the flushing adapter 130 and in fluid communication with the lumen of the flushing adapter 130. The flushing arm 140 may be coupled to a syringe, medical line, fluid bag, or the like, as described in more detail herein, to provide fluid to the lumen 102 of the system 100.

[0024] 2A-2D show cross-sectional views of an embodiment of a system 100. In one embodiment, the system 100 can define a lumen 102 extending between a distal end of the catheter adapter 110 and a proximal end of the flushing adapter 130. In one embodiment, the catheter adapter 110 can include a first cannula 112 defining a portion of the lumen 102. The distal end of the first cannula 112 can extend distally from the distal end of the housing 114 of the catheter adapter 110 and can be configured to engage the proximal end of the catheter 160 to provide fluid communication with the lumen 162 of the catheter 160. In one embodiment, the first cannula 112 can be formed from a metal, alloy, stainless steel, or similar conductive material.

[0025] 2A-2B, in one embodiment, flushing arm 140 can provide saline to lumen 102 of system 100 and to catheter 160. The proximal end of flushing arm 140 can include a second locking valve 146 configured to selectively control fluid flow therethrough. Thus, once saline has been flushed through system lumen 102 and catheter lumen 162 to the distal end of catheter 160, second locking valve 146 can be closed to "lock" the flow of solution and establish a saline column that extends to distal end 164 of catheter 160 (FIG. 2B).

[0026] In one embodiment, the catheter adapter housing 114 can include a socket 116 configured to receive a portion of the clip 170 therein. In use, a user can insert the clip 170 into the socket 116 and engage a portion of the first cannula 112 to establish an electrical connection between the clip 170 and the first cannula 112 ( FIG. 2B ). Thus, an electrical pathway can be established from the distal tip of the catheter 160, through the saline column, the first cannula 112, the clip 170, the first tether 172, and to the sensor 90 and / or the multimodal tracking system 80. The electrical pathway can communicate ECG signals received at the distal tip 164 of the catheter 160 to the multimodal tracking system 80 to determine the position of the distal tip 164 of the catheter 160 relative to a target location.

[0027] 2A , the flushing adapter 130 can include a second cannula 132 that defines a second portion of the system lumen 102, as described herein, and the second cannula 132 can also be formed from a metal or conductive material. In one embodiment, a second tether 176 can be fixedly coupled to the second metal cannula 132 to provide an electrical connection between the second tether 176 and the second metal cannula 132. Thus, an electrical pathway can be established from the distal tip 164 of the catheter 160, through the saline column, the second cannula 132, the second tether 176, and to the sensor 90 and / or the multimodal tracking system 80. The electrical pathway can communicate ECG signals received at the distal tip 164 of the catheter 160 to the multimodal tracking system 80 to determine the position of the distal tip 164 of the catheter 160 relative to the target location.

[0028] In one embodiment, the catheter adapter 110, including the clip 170 and first tether 172, can establish a first electrical path, and the flushing adapter 130, including the second tether 176, can establish a second electrical path. Advantageously, the multimodal tracking system 80 can cross-check the received ECG signals using both the first and second electrical paths to determine the accuracy of the position of the distal tip 164 of the catheter 160. For example, if the difference between the position calculated by the first path and the position calculated by the second path is relatively large, the estimated position can be averaged between the two signals and / or the accuracy or confidence rating can be classified as relatively low. Alternatively, if the difference between the two paths is relatively small, the position can be averaged and / or the accuracy rating can be relatively high. The position and accuracy rating can then be displayed to the user by the multimodal tracking system 80.

[0029] Advantageously, as described in more detail herein, the system 100 including the catheter adapter 110 and clip 170 can provide a versatile means for establishing an electrical pathway because the clip 170 can be selectively separated from the catheter adapter 110 and directly coupled to one of the stylet 150, guidewire 250, access needle, or catheter 160, as required by the particular catheter placement procedure being used. Furthermore, the flushing adapter 130, with the second tether 176 fixedly coupled thereto, can form a reliable electrical connection, maintaining at least one electrical pathway between the catheter distal tip and the multimodal tracking system 80 while the clip 170 can be exchanged between one of the catheter adapter 110, stylet 150, guidewire 250, access needle, or catheter 160 as needed. Similarly, the clip 170 can maintain at least one electrical pathway between the catheter distal tip 164 and the multimodal tracking system 80 while one or more of the stylet 150, guidewire 250, or flushing adapter 130 are exchanged, as described in more detail herein. Advantageously, the system 100, including both the catheter adapter 110 and the flushing adapter 130, can provide a fail-safe system to ensure that electrical communication with the distal tip of the catheter 160 remains uninterrupted and the position of the distal tip of the catheter 160 can be continuously ascertained.

[0030] In one embodiment, the system 100 may further include one of a stylet 150 or a guidewire 250 extending through the system lumen 102 into the catheter lumen 162 and to the distal tip 164 of the catheter 160. In one embodiment, as shown in FIGS. 2A-2B , the stylet 150 may be a separate structure and may be slidably engaged with the system lumen 102. In one embodiment, the stylet 150 may be selectively locked in position relative to one of the lumen 102 or the distal tip 164 of the catheter 160 using a locking valve 136, as described herein.

[0031] In one embodiment, the stylet 150 or the guidewire 250 may be formed from a conductive material to provide an electrical pathway therethrough. In one embodiment, the clip 170 may be detached from the catheter adapter 110 and coupled to the proximal end of one of the stylet 150 or the guidewire 250. Thus, a third electrical pathway may be established from the distal tip 154 ​​of the stylet 150, which is positioned proximate the distal tip 164 of the catheter 160, through the stylet 150, the clip 170, the first tether 172, and to the sensor 90 and / or the multimodal tracking system 80.

[0032] Advantageously, the user can switch the clip 170 between the socket 116 and the stylet 150 depending on the reliability of the connection, the strength of the electrical signal, the stage in the placement of the catheter 160, etc., to cross-reference the accuracy of the second electrical pathway and alternate electrical pathways to ensure a consistent signal is provided to the sensor 90 and combinations thereof, etc.

[0033] In one embodiment, as shown in FIGS. 2B-2C , the second tether 176 can be fixedly coupled to the stylet 150 or guidewire 250 to provide an electrical connection between the second tether 176 and the stylet 150 or guidewire 250. For example, as shown in FIG. 2B , the second tether 176 can extend through a wall of the flushing adapter housing 134 and be fixedly attached to the stylet 150. In one embodiment, the second tether 176 can be fixedly attached directly to the proximal end 156 of the stylet 150, i.e., without contacting the flushing adapter 130, similar to the configuration shown in FIG. 2D . In one embodiment, the second tether 176 can be fixedly attached to the stylet 150 using adhesives, welding, soldering, bonding, etc. to provide a reliable electrical connection with the stylet 150. Advantageously, the stylet 150 can still be slidably engaged with the system lumen 102.

[0034] As shown in FIG. 2C , in one embodiment, the stylet 150 can be fixedly coupled to the flushing adapter housing 134 to provide a reliable connection therewith. Thus, in one embodiment, a user can remove the stylet 150 from the catheter 160 by separating the flushing adapter 130 from the catheter adapter housing 110 and withdrawing the flushing adapter 130 proximally. Advantageously, the stylet 150, being integrally formed with the flushing adapter housing 130, can provide an additional electrical pathway from the distal tip 164 of the catheter 160 through the stylet 150 and / or the saline column to the multimodal tracking system 80. In one embodiment, the stylet 150 can be fixedly coupled to the catheter adapter housing 114 to provide a reliable connection therewith, and a second tether 176 can be coupled to the catheter adapter 110 to provide a second electrical pathway, as described herein.

[0035] As shown in FIG. 2D , in one embodiment, the system 100 can further include a guidewire 250 configured to extend through the system lumen 102, through the catheter lumen 162, and into the patient's vasculature. In one embodiment, the guidewire 250 is formed from a conductive material, as described herein, and can provide an electrical pathway between a distal tip 254 of the guidewire 250 proximate the catheter distal tip 164 and one or both of the electrical pathways of the clip 170 and first tether 172 or the electrical pathways of the flushing adapter 130 and second tether 176. In one embodiment, the guidewire 250 can include a corewire 260 and a coil wire 262 helically extending over the corewire 260. In one embodiment, one or both of the corewire 260 and the coil wire 262 can provide an electrical pathway as described herein. Additionally, the proximal end of either or both of core wire 260 or coil wire 262 may be coupled to either or both of first tether 172 or second tether 176 as described herein.

[0036] In one embodiment, either the stylet 150 or the guidewire 250, or both, can include a magnetic element 180 coupled to the stylet 150 or guidewire 250 proximate their distal tips 154, 254. The magnetic element 180 can be a permanent magnet or an electromagnet. Advantageously, the multi-modal tracking system 80 can detect magnetic field strength and determine the position of the distal tip 164 of the catheter 160, which is positioned proximate the magnetic element 180, as the catheter 160 is advanced through the patient's vasculature. Further details and embodiments of the multimodal tracking system 80 using one or more of ultrasound imaging, magnetic tracking or tip confirmation, ECG tracking or tip confirmation, or a combination thereof, etc., are described in U.S. Pat. Nos. 8,971,994, 9,492,097, 9,636,031, 10,238,418, 10,966,630, 11,027,111, and 11,027,111. No. 2018 / 0116551, U.S. Patent Application No. 2018 / 0304043, U.S. Patent Application No. 2019 / 0069877, U.S. Patent Application No. 2019 / 0099108, U.S. Patent Application No. 2020 / 0054858, U.S. Patent Application No. 2020 / 0237255, and U.S. Patent Application No. 2020 / 0345983, all of which are incorporated herein by reference in their entireties.

[0037] In an exemplary method of use, a multi-function adapter system ("system") 100 is provided as described herein. A user can couple a first cannula 112 extending from the distal tip of the catheter adapter housing 114 to a proximal end of a catheter 160, such as by an interference fit, to provide fluid communication between the first cannula 112 and the catheter 160. In one embodiment, the distal end of the flushing adapter 130 can be coupled to the proximal end of the catheter adapter 110. In one embodiment, a stylet 150 or guidewire 250 can be fixedly coupled to the flushing adapter 130. Accordingly, coupling the flushing adapter 130 can further include extending the stylet 150 or guidewire 250 through the first cannula 112 and into the catheter lumen 162. When the flushing adapter 130 is engaged with the catheter adapter 110 , the distal tip of the stylet 150 or guidewire 250 can be aligned with the distal tip 164 of the catheter 160 .

[0038] In one embodiment, the stylet 150 or guidewire 250 may be formed as a separate structure from the flushing adapter 130. Thus, once the flushing adapter 130 is coupled to the catheter adapter 110, the stylet 150 or guidewire 250 may be slidably engaged with the system lumen 102. The distal tip of the stylet 150 or guidewire 250 may extend to the distal tip 164 of the catheter 160. In one embodiment, the position of the stylet 150 or guidewire 250 may be locked relative to the system lumen 102 using the locking valve 136. In one embodiment, a syringe, medical line, or the like may be coupled to the flushing arm 140 of the flushing adapter 130, and the system lumen 102 and catheter lumen 162 may be flushed with saline. A second locking valve 146 may then lock the saline solution, establishing a saline column.

[0039] In one embodiment, one of the stylet 150 or the guidewire 250 can include a magnetic element 180 disposed at its distal tip. The distal tip of the catheter 160 can then be advanced through the patient's vasculature toward the target location. One or both of the sensor 90 and the multi-modal tracking system 80 can detect the magnetic field strength of the magnetic element 180 to track the position of the distal tip 164 of the catheter 160 as it moves through the vasculature toward the target location. Optionally, the multi-modal tracking system 80 can further include an ultrasound imaging system configured to image the subcutaneous portion of the patient. As the distal tip 164 of the catheter 160 approaches the target location, the system 100 can detect ECG signals at the distal tip 164 of the catheter 160 to ascertain the position of the distal tip 164 relative to the target location with much greater accuracy than can be achieved with magnetic tracking modalities. The system 100 may provide one or more electrical pathways to provide ECG signals to the multimodal tracking system 80. The ECG signals from two or more electrical pathways may be cross-referenced to confirm placement accuracy and maintain consistent ECG signals during the placement procedure.

[0040] Once the catheter 160 is successfully positioned, the stylet 150 or guidewire 250 can be withdrawn proximally. Advantageously, the catheter adapter 110 can maintain an ECG electrical pathway to ensure that the distal tip of the catheter 160 does not move during withdrawal of the stylet 150 or guidewire 250. In one embodiment, the flushing adapter 130 can be separated from the catheter adapter 110 and withdrawn proximally. In one embodiment, one of the stylet 150 or guidewire 250 can be fixedly coupled to the flushing adapter 130 described herein. Thus, separating and withdrawing the flushing adapter 130 from the catheter adapter 110 can include withdrawing the stylet 150 and guidewire 250 from the catheter lumen 162. Advantageously, the clip 170 and catheter adapter 110 can maintain an ECG electrical pathway to ensure that the distal tip 164 of the catheter 160 does not move during separation and withdrawal of the flushing adapter 130 and / or stylet 150 or guidewire 250.

[0041] In one embodiment, the catheter adapter 110 can then be separated from the catheter 160, and the stylet 150, with the clip 170 coupled thereto, can be reinserted into the catheter 160. The distal tip of the stylet 150 can be advanced to the distal tip of the catheter 160, and the multi-modal tracking system 80 can detect an ECG signal at the distal tip of the catheter 160 to reconfirm that the distal tip of the catheter 160 has not moved from the target location.

[0042] In one embodiment, a port or similar subcutaneous access device can be coupled to the catheter 160 by pushing the stem of the port into the proximal end of the catheter lumen 162. During the process of coupling the port to the catheter 160, the distal tip of the catheter 160 may be moved. To reconfirm that the distal tip of the catheter 160 is properly positioned, an access needle, such as a Huber needle, can be used to access the port and catheter 160 assembly and flush the assembly with saline to establish a saline plume. The clip 170 of the system 100 can then be coupled to the access needle to establish an electrical pathway through the saline plume, access needle, and clip 170 to the distal tip of the catheter 160 and reconfirm the position of the distal tip 164 of the catheter 160.

[0043] Although some specific embodiments have been disclosed herein, and the specific embodiments have been 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 in its broader aspects, these adaptations and / or modifications are likewise encompassed. Thus, departures may be made from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A catheter tip verification system, comprising: a catheter adapter having a catheter adapter housing with a first cannula defining a lumen, the first cannula formed from an electrically conductive material, a distal end of the catheter adapter housing configured to engage a proximal end of a catheter to provide fluid communication with the first cannula; a clip coupled to a first tether, the clip configured to engage a socket disposed in the catheter adapter housing to releasably engage the first cannula and receive a first ECG signal; a flushing adapter releasably coupled to a proximal end of the catheter adapter housing and configured to provide a column of saline into the first cannula and into the catheter, the flushing adapter comprising a second tether fixedly coupled to the flushing adapter and configured to receive a second ECG signal; an elongate medical device extending through a lumen of the first cannula, a distal tip of the elongate medical device extending to a distal tip of the catheter, the elongate medical device comprising a magnet disposed at the distal tip of the elongate medical device; Equipped with the socket has an opening formed in a wall of the catheter adapter housing; the clip is configured to be inserted into the opening from outside the catheter adapter housing and engage the first cannula; a portion of the clip protruding from the opening to the exterior of the catheter adapter housing when the clip is inserted into the opening and engaged with the first cannula.

2. The catheter tip verification system of claim 1 , wherein the second tether is coupled to the elongate medical device to receive the second ECG signal from the distal tip of the elongate medical device.

3. The catheter tip confirmation system of claim 1 or 2, wherein the elongated medical device comprises one of a stylet, a guidewire, or a guidewire with a coil on its core.

4. 2. The catheter tip verification system of claim 1, wherein the second tether is coupled to a second cannula that defines a lumen of the flushing adapter and is in fluid communication with the first cannula, the second tether being configured to receive the second ECG signal from the saline column that extends to the distal tip of the catheter.

5. 5. The catheter tip verification system of claim 1, wherein the clip is configured to be selectively separated from the first cannula and coupled to a proximal portion of the elongated medical device to receive the first ECG signal from the distal tip of the elongated medical device.

6. The catheter tip verification system of any one of claims 1 to 5, wherein the elongated medical device is fixedly coupled to the flushing adapter.

7. The catheter tip verification system of any one of claims 1 to 6, wherein the flushing adapter further comprises a flushing arm configured to provide fluid communication with the flushing adapter.

8. 8. The catheter tip verification system of claim 1, wherein the flushing adapter further comprises a locking valve configured to transition between a locked position and an unlocked position, the locking valve in the locked position configured to prevent longitudinal movement of the elongated medical device relative to the flushing adapter.

9. 9. The catheter tip verification system of claim 8, wherein the locking valve further comprises a valve member configured to control fluid flow therethrough in both the locked and unlocked positions.

10. 10. The catheter tip verification system of claim 1, further comprising a console configured to compare one of the first ECG signal and the second ECG signal to determine accuracy of the position of the distal tip of the catheter.

11. 11. The catheter tip verification system of claim 10, wherein the console is further configured to detect a magnetic field at the distal tip of the elongated medical device and determine a position of the distal tip of the catheter within a patient.

12. The catheter tip confirmation system according to any one of claims 1 to 11, wherein the first cannula is made of a metal, an alloy, or a conductive material.

13. 13. The catheter tip confirmation system of claim 1, wherein the catheter comprises one of a central venous catheter, a peripherally inserted central catheter, a rapid insertion central catheter, a midline catheter, a single lumen catheter, a multi-lumen catheter, or a dialysis catheter.

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