Catheter system with guidewire slider

Abstract

The catheter system may include a catheter assembly and a needle assembly. The catheter assembly may include a catheter adapter, which may include a distal end, a proximal end, a lumen, and a side port. The catheter assembly may include a catheter and an extension tube extending from the distal end of the catheter adapter. The distal end of the extension tube may be integrated into the side port of the catheter adapter. The needle assembly may include a safety housing or a needle safety element, which may be disposed within the catheter adapter. The needle assembly may include a guidewire advancement device coupled to the safety housing or the catheter adapter, and an introducer needle having a proximal end coupled to the guidewire advancement device.

Description

[Technical Field]

[0001] The present invention relates to a catheter system having a guidewire slider. [Background technology]

[0002] (background) Arterial catheterization is a critical procedure widely used in all hospital settings, both in critically injured and perioperative patients. It is estimated that more than 8 million arterial catheters are placed annually in the United States. Arterial catheters can continuously and accurately measure blood pressure, as well as heart rate and pulse contour, allowing for immediate recognition of abnormal hemodynamic events and initiation of appropriate treatment. Arterial catheters also provide samples for blood gas analysis without the morbidity associated with repeated arterial punctures. However, the use of current arterial catheters can result in significant blood leakage during insertion into a patient's artery, which can put the user at risk. Furthermore, current arterial catheters can be difficult to use with probes or catheter advancement devices.

[0003] The subject matter claimed herein is not limited to embodiments that solve the problems or that operate only in the contexts described above. Rather, this background is only provided to illustrate one example technology area where some embodiments described herein may be practiced. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent No. 9,220,871 [Patent Document 2] U.S. Patent Application No. 17 / 709,935 [Patent Document 3] U.S. Patent No. 10,507,281 [Patent Document 4] U.S. Patent No. 7,972,313 [Patent Document 5] U.S. Patent No. 11,291,803 Summary of the Invention

[0005] The present disclosure relates generally to vascular access devices, systems, and methods. More specifically, the present disclosure relates to catheter assemblies and related devices and methods. In some embodiments, a catheter system can be configured for blood sampling, such as arterial blood sampling. In some embodiments, the catheter system can also be configured for blood pressure monitoring and / or blood gas sampling. Importantly, in some embodiments, the catheter system can provide closer access to the patient for more accurate hemodynamic measurements and improved delivery of instruments, such as secondary catheters and / or probes, inserted into blood vessels, which may include arteries or veins. In some embodiments, the catheter system can include a guidewire to improve the success rate of catheter insertion. In some embodiments, the catheter system can reduce blood exposure when inserting a catheter into a patient's artery.

[0006] In some embodiments, the catheter system may include a catheter assembly. In some embodiments, the catheter assembly may include a catheter adapter, which may include a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter. In some embodiments, the catheter adapter may also include a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter, which may be in fluid communication with the lumen. In some embodiments, the catheter assembly may include a catheter extending from the distal end of the catheter adapter.

[0007] In some embodiments, the catheter assembly may include an extension tube having a distal end and a proximal end. In some embodiments, the distal end of the extension tube may be integrated into a side port of the catheter adapter. In some embodiments, the extension tube may be a first extension tube. In some embodiments, the catheter system may include a second extension tube, which may have a distal end and a proximal end. In some embodiments, the catheter system may include an access connector, which may be configured to provide access near the patient. In some embodiments, the access connector may include a distal port, a proximal port, and a side port between the distal and proximal ports. In some embodiments, the distal and proximal ports may be aligned with a longitudinal axis of the access connector. In some embodiments, the side port may be angled relative to the longitudinal axis of the access connector. In some embodiments, the proximal end of the first extension tube may be integrated with the distal port of the access connector.

[0008] In some embodiments, the distal end of the second extension tube may be integrated with the side port of the access connector. In some embodiments, the first extension tube may be shorter than the second extension tube such that the first extension tube facilitates advancement of a secondary catheter and / or probe therethrough. In some embodiments, the longitudinal axes of the access connector, the first extension tube, and the side port may be configured to align to form a linear path, which may facilitate advancement of a secondary catheter and / or probe within the catheter system. In some embodiments, the first extension tube may be rigid or semi-rigid, which may facilitate advancement of a secondary catheter and / or sensor therethrough.

[0009] In some embodiments, the proximal port may include a female luer, which may facilitate coupling of the catheter advancement device to the access connector. In some embodiments, the proximal port may include another suitable connector. In some embodiments, the catheter advancement device may be coupled to the proximal port. In some embodiments, the catheter advancement device may include a PIVO® needleless blood collection device available from Becton, Dickinson & Company of Franklin Lakes, New Jersey, or another suitable catheter advancement device. In some embodiments, the catheter advancement device may include a blood sampling device.

[0010] In some embodiments, the catheter system may include a needle assembly that may include one or more of a safety housing, a guidewire advancement device, and an introducer needle. Active safety mechanisms (e.g., pressing a button) require user activation of the active safety mechanism, while passive safety mechanisms are automatically activated during normal use of the catheter system (e.g., withdrawing the introducer needle). In some embodiments, the catheter system may include a distal tip needle safety element of the introducer needle configured to shield the sharp needle. In some embodiments, the needle safety element may include a V-clip needle shield, a cross-arm clip, or another suitable spring clip or another passive safety mechanism configured to shield the introducer needle. In some embodiments, the needle safety element may be disposed within the safety housing or within the catheter adapter. In some embodiments, the needle safety element disposed within the safety housing may protect the user from blood splatter exiting the sharp distal tip of the introducer needle and may also protect the user from the sharp distal tip. In some embodiments, the safety housing may include a distal end and a proximal end. In some embodiments, the distal end of the needle hub may be coupled to the proximal end of the catheter adapter.

[0011] In some embodiments, the guidewire advancement device may include a distal end and a proximal end. In some embodiments, the distal end of the guidewire advancement device may be coupled to the proximal end of the safety housing. In some embodiments without a safety housing, the distal end of the guidewire advancement device may be coupled to the proximal end of the catheter adapter. In some embodiments, the introducer needle may include a proximal end coupled to the guidewire advancement device. In some embodiments, the introducer needle may extend through the catheter. In some embodiments, removing the guidewire advancement device from the catheter system may be configured to withdraw the guidewire and introducer needle from the catheter system. In some embodiments, the guidewire may be configured to remain in the protruding portion of the introducer needle when the guidewire and introducer needle are withdrawn from the catheter system.

[0012] In some embodiments, the guidewire advancement device may include a slot and an advancement tab linearly movable along the slot. In some embodiments, the advancement tab may be configured to advance the guidewire distally and / or retract the guidewire proximally. In some embodiments, the longitudinal axis of the guidewire advancement device may be aligned with the longitudinal axis of the catheter assembly. In some embodiments, the guidewire advancement device may include a rack and pinion. In some embodiments, the advancement tab may include a rack. In some embodiments, the guidewire advancement device may include a rotating element configured to advance the guidewire distally and / or retract the guidewire proximally.

[0013] In some embodiments, the introducer needle may include a sharp distal tip, a proximal end, and a lumen extending through the sharp distal tip and the proximal end. In some embodiments, a guidewire may be disposed within the lumen of the introducer needle and / or configured to move through the proximal end of the introducer needle and advance distally. In some embodiments, the introducer needle may include an external groove. In some embodiments, a guidewire may be disposed within the external groove and configured to move through the external groove and advance distally and / or be withdrawn proximally.

[0014] In some embodiments, the safety housing may include an open space adjacent and proximal to the V-clip needle shield. In some embodiments, the guidewire may be configured to bend within the open space when the V-clip needle shield is fired. In some embodiments, the sharp distal tip may include an upward bevel, and the V-clip needle shield may be configured to fire left or right. In some embodiments, the sharp distal tip may include an upward bevel, and the V-clip needle shield may be configured to fire in an upward or downward direction.

[0015] In some embodiments, the introducer needle can include an opening disposed between the sharp distal tip and the proximal end of the introducer needle, hi some embodiments, the guidewire can be configured to extend from the sharp distal tip of the introducer needle through the extension tube, the side port, and the opening.

[0016] In some embodiments, the proximal end of the second extension tube may be integrated with the adapter. | In some embodiments, the adapter may be coupled to a needleless connector, which may reduce the risk of bacterial contamination. In some embodiments, the proximal end of the adapter may include a single port or dual ports.

[0017] In some embodiments, the method may include inserting a catheter system into a patient's blood vessel. In some embodiments, the blood vessel may be an artery. In some embodiments, the catheter system may be inserted into the blood vessel by puncturing the skin and the blood vessel with an introducer needle and placing a catheter within the blood vessel. In some embodiments, the method may include, after inserting the catheter system into the blood vessel, distally advancing a guidewire through the guidewire advancing device. In some embodiments, after distally advancing the guidewire, the method may include removing the guidewire advancing device from the catheter system. In some embodiments, removing the guidewire advancing device from the catheter system may be configured to withdraw the guidewire and introducer needle from the catheter system. In some embodiments, the guidewire may be configured to remain on the protruding portion of the introducer needle when the guidewire and introducer needle are withdrawn from the catheter system.

[0018] In some embodiments, the method may include, after removing the guidewire-advancing device from the catheter system, coupling the catheter-advancing device to the proximal port and advancing a secondary catheter into the catheter assembly via the catheter-advancing device. In some embodiments, the method may include, after removing the guidewire-advancing device from the catheter system, coupling a probe-advancing device to the proximal port and advancing a probe of the probe-advancing device into the catheter assembly. In some embodiments, the probe may include one or more sensors configured to measure one or more properties of the blood.

[0019] According to another set of embodiments, a catheter system may include a catheter adapter that may include a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter. In some embodiments, the catheter system may include a catheter extending from the distal end of the catheter adapter. In some embodiments, the catheter system may include a guidewire advancement device coupled to the catheter adapter. In some embodiments, the guidewire advancement device may include a casing, a guidewire at least partially disposed within the casing, and a roller wheel element extending through the casing and contacting the guidewire. In some embodiments, the guidewire may be configured to advance distally in response to proximal rotation of the roller wheel element. In some embodiments, the catheter system may include an introducer needle that may include a proximal end and a sharp distal tip. In some embodiments, the proximal end of the introducer needle may be secured within the guidewire advancement device. In some embodiments, the introducer needle may extend through the catheter.

[0020] In some embodiments, the catheter system may include a platform disposed within the casing and beneath the roller wheel element. In some embodiments, the platform may include a linear groove. In some embodiments, the guidewire may be disposed within the linear groove, which may facilitate guidance of the guidewire during distal advancement of the guidewire. In some embodiments, the catheter system may include opposing roller wheel support grooves disposed within the casing. In some embodiments, the roller wheel element includes opposing pins configured to rotate within the opposing support grooves.

[0021] In some embodiments, the distal end of the casing may include a male rear fitting that can facilitate coupling to the catheter adapter and / or safety housing. In some embodiments, the catheter system may include a septum and a septum actuator disposed within the lumen of the catheter adapter. In some embodiments, the septum may help stop blood flow through the catheter adapter when the catheter adapter is not engaged with an external connector or extension set. In some embodiments, the fluid path through the catheter adapter may be closed unless an external connector is engaged with the catheter adapter, such that the septum actuator opens the septum.

[0022] According to another set of embodiments, a guidewire advancement device coupled to a catheter adapter may include a casing, a slot in the casing, a guidewire, and an advancement tab configured to extend through the slot and move along the slot to distally advance the guidewire.

[0023] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claimed invention. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. Also, it is to be understood that embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief explanation of the drawings]

[0024] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Figure 1A] FIG. 1 is a top perspective view of an exemplary catheter system showing an exemplary linear guidewire advancement device, according to some embodiments. [Figure 1B] FIG. 1 is a cross-sectional view of a catheter system showing an exemplary advancement tab in an exemplary proximal position, according to some embodiments. [Figure 1C] 1A-1C are cross-sectional views of a catheter system showing an advancement tab in an exemplary distal position, according to some embodiments. [Figure 2A] FIG. 1 is a top perspective view of a catheter system showing an exemplary rotational guidewire advancement device, according to some embodiments. [Figure 2B] FIG. 1 is a cross-sectional view of a catheter system showing an exemplary rotating element in a first position, according to some embodiments. [Figure 2C] FIG. 10 is a cross-sectional view of a catheter system showing a rotating element rotated to a second position, according to some embodiments. [Figure 2D] 1 provides an exploded rear view of an isolated rotating element, according to some embodiments. [Figure 3A] FIG. 10 is a top perspective view of an exemplary introducer needle having grooves, according to some embodiments. [Figure 3B] 1 is a cross-sectional view of an introducer needle according to some embodiments. [Figure 4A] FIG. 10 is a top perspective view of an introducer needle having an exemplary opening and a guidewire extending therethrough, according to some embodiments. [Figure 4B] 1 is a partial cross-sectional view of a catheter system showing an introducer needle having an opening, according to some embodiments. [Figure 4C] 1 is a cross-sectional view of an exemplary adapter, according to some embodiments. [Figure 5A] FIG. 1 illustrates a top perspective view of an exemplary V-clip needle shield, according to some embodiments. [Figure 5B] FIG. 12 is a cross-sectional view of a V-clip needle shield separating from an exemplary catheter adapter groove, according to some embodiments. [Figure 5C]1A-1C are cross-sectional views of a catheter system showing an introducer needle proximally retracted into an exemplary safety housing prior to separating the safety housing from an exemplary catheter adapter, according to some embodiments. [Figure 6A] 1A-1C are partial cutaway views of a catheter system showing an exemplary capture mechanism where an introducer needle is exposed from the distal end of an exemplary inner housing, according to some embodiments. [Figure 6B] FIG. 10 is a partial cutaway view of a catheter system showing a capture mechanism in which the introducer needle is retracted within an internal housing, according to some embodiments. [Figure 6C] FIG. 1 is a partial cutaway view of a catheter system showing a capture mechanism being removed from a catheter adapter, according to some embodiments. [Figure 7] FIG. 10 illustrates a top perspective view of an exemplary spring clip with a shielded introducer needle, according to some embodiments. [Figure 8A] FIG. 10 is a cross-sectional view of an example advancement tab with an example pinion and an example rack, showing the advancement tab in a first, proximal position, according to some embodiments. [Figure 8B] FIG. 10 is a cross-sectional view of an exemplary pinion with rack and advancement tab showing the advancement tab in an exemplary second distal position, according to some embodiments. [Figure 9A] FIG. 1 is a side view of another exemplary catheter system, according to some embodiments. [Figure 9B] FIG. 10 is a cross-sectional view of the catheter system of FIG. 9, according to some embodiments. [Figure 9C] 9B is another cross-sectional view of the catheter system of FIG. 9, taken across the cross-sectional view of FIG. 9B, in accordance with some embodiments. [Figure 9D] FIG. 10 is a top perspective view of the catheter system of FIG. 9 illustrating an exemplary casing in an open position according to some embodiments. [Figure 9E] FIG. 1 illustrates a top perspective view of an exemplary diaphragm actuator, according to some embodiments. [Figure 9F]1 is a top perspective view of an exemplary bulkhead, according to some embodiments. FIG. [Figure 9G] FIG. 10 is a top perspective view of an exemplary roller wheel element disposed within exemplary opposing support grooves, according to some embodiments. [Figure 9H] FIG. 10 is a top perspective view of roller wheel elements positioned within opposing support grooves according to some embodiments. [Figure 10A] FIG. 10 is a top perspective view of another catheter system showing an exemplary advancement tab in an exemplary proximal position, according to some embodiments. [Figure 10B] FIG. 10 is a top perspective view of an advancement tab coupled to an exemplary guidewire, according to some embodiments. [Figure 10C] FIG. 10B is a top perspective view of the catheter system of FIG. 10A showing the advancement tab in an exemplary distal position, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0025] (Description of the embodiment) 1A-1C, a catheter system 10 is shown, according to some embodiments. In some embodiments, the catheter system 10 may be configured for blood sampling, such as arterial blood sampling. In some embodiments, the catheter system 10 may also be configured for blood pressure monitoring and / or blood gas sampling. Importantly, in some embodiments, the catheter system 10 may provide closer access to the patient for more accurate hemodynamic measurements and improved delivery of instruments, such as secondary catheters and / or sensors, to blood vessels, which may include arteries or veins. In some embodiments, the secondary catheter may include another catheter configured to extend through the catheter 19 to extend the life of the catheter 19, and the secondary catheter may be used for blood withdrawal and / or infusion.

[0026] 1-8 may be referred to as an "integrated" catheter system, meaning that the catheter system includes an extension tube (e.g., an extension set) that provides a fluid pathway to the catheter. In some embodiments, the catheter system 10 may be similar in one or more components and / or operation to the NEXIVA® Closed IV Catheter System, the NEXIVA® DIFFUSICS® Closed IV Catheter System, or the PEGASUS® Safety Closed IV Catheter System (all available from Becton Dickinson & Company of Franklin Lakes, New Jersey), or another suitable integrated catheter system.

[0027] In some embodiments, the catheter system 10 may include an arterial catheter system configured for insertion into an artery. In these embodiments, the catheter system 10 may include a significant improvement over existing arterial catheter systems by dramatically reducing blood exposure and infection risk, providing improved arterial access confirmation for users, and improving the overall patient experience. For example, some existing arterial catheter systems, such as the TeleflexARROW® integrated arterial catheter, may not provide effective arterial access confirmation or blood control, resulting in a placement procedure that involves significant blood exposure risk, infection risk, cleanup costs, and a negative patient experience. The TeleflexARROW® integrated arterial catheter includes a non-rigid slotted tube that can leak a significant amount of blood, potentially endangering the user.

[0028] The catheter system 10 may include one or more of the following, which may provide advantages over conventional techniques: arterial blood sampling with reduced blood exposure, blood pressure monitoring, blood gas sampling, close-to-patient access for use of secondary catheters and / or sensors, blood control configured to operate under arterial pressure, guidewires, and magnetic introducer needle guidance technology.

[0029] As shown in FIGS. 1A-1C, in some embodiments, a catheter system 10 may include a catheter adapter 12, which may include a distal end 14, a proximal end 16, and a lumen extending through the distal end 14 and the proximal end 16 of the catheter adapter 12. In some embodiments, the catheter adapter 12 may also include a side port 18 between the distal end 14 and the proximal end 16 of the catheter adapter, which may be in fluid communication with the lumen. In some embodiments, the catheter assembly may include a catheter 19 extending from the distal end 14 of the catheter adapter 12. In some embodiments, the catheter 19 may include an arterial catheter, a peripherally inserted central catheter, a central catheter, a peripheral intravenous catheter, or another suitable catheter.

[0030] In some embodiments, the catheter assembly may include an extension tube 20 including a distal end 22 and a proximal end 24. In some embodiments, the distal end 22 of the extension tube 20 may be integrated with the side port 18 of the catheter adapter 12, which may reduce the risk of fluid exposure to the user. More specifically, in some embodiments, the distal end 22 of the extension tube 20 may be permanently or permanently coupled to the side port 18 of the catheter adapter 12 via, for example, an adhesive, glue, a non-luer coupling, or another suitable permanent or non-removable coupling.

[0031] In some embodiments, the extension tube 20 may be a first extension tube. In some embodiments, the catheter system 10 may include a second extension tube 26, which may include a distal end 28 and a proximal end 30. In some embodiments, the catheter system 10 may include an access connector 32, which may be configured to provide proximal access to the patient for one or more of blood sampling, a probe, or a secondary catheter. In some embodiments, the access connector 32 may include a distal port 34, a proximal port 36, and a side port 38 between the distal port 34 and the proximal port 36. In some embodiments, the distal port 34 and the proximal port 36 may be aligned with a longitudinal axis 40 of the access connector. In some embodiments, the side port 38 may be angled relative to the longitudinal axis 40 of the access connector 32. In some embodiments, the proximal end 24 of the extension tube 20 may be integral with the distal port 34 of the access connector 32, which may reduce the risk of fluid exposure to the user. More particularly, in some embodiments, the proximal end 24 of the extension tube 20 may be permanently or non-removably coupled to the distal port of the access connector, for example, via adhesive, glue, non-luer coupling, or another suitable permanent or non-removable coupling.

[0032] In some embodiments, the distal end 28 of the second extension tube 26 may be integral with the side port 38 of the access connector 32, which may reduce the risk of fluid exposure to the user. More specifically, in some embodiments, the distal end 28 of the second extension tube 26 may be permanently or non-removably coupled to the side port 38 of the access connector 32, for example, via adhesive, glue, non-luer coupling, or another suitable permanent or non-removable coupling. In some embodiments, the extension tube 20 may be short to facilitate access closer to the patient. In some embodiments, the extension tube 20 may be shorter than the second extension tube 26, such that the extension tube 20 facilitates advancement of a secondary catheter and / or probe through the extension tube 20 and proximal port 36. In some embodiments, the longitudinal axes 40 of the access connector 32, the extension tube 20, and the side port 18 may be configured to align to form a linear path, which may facilitate advancement of a secondary catheter and / or probe within the catheter system 10. In some embodiments, the extension tube 20 may be rigid or semi-rigid, which may facilitate the advancement of secondary catheters and / or sensors therethrough.

[0033] In some embodiments, the proximal port 36 may include a female luer, which may facilitate coupling of a catheter advancement device to the access connector 32. In some embodiments, the proximal port 36 may include another suitable connector. In some embodiments, a catheter advancement device may be coupled to the proximal port 36. In some embodiments, the catheter advancement device may include a PIVO® needleless blood collection device available from Becton, Dickinson & Company of Franklin Lakes, New Jersey, or another suitable catheter advancement device. In some embodiments, the catheter advancement device may include a blood sampling device.

[0034] In some embodiments, the catheter system 10 may include a needle assembly 42 that may include one or more of a safety housing 44, a V-clip needle shield 46 disposed within the safety housing 44, a guidewire advancement device 48, and an introducer needle 50. In some embodiments, the safety housing 44 may include a distal end 52 and a proximal end 54. In some embodiments, the distal end 52 of the needle hub of the safety housing 44 may be coupled to the proximal end 16 of the catheter adapter 12.

[0035] In some embodiments, guidewire advancement device 48 may include a distal end 56 and a proximal end 58. In some embodiments, distal end 56 of guidewire advancement device 48 may be removably coupled to proximal end 54 of safety housing 44. In some embodiments, introducer needle 50 may include a proximal end 60 coupled to guidewire advancement device 48 such that proximal end 60 is secured within guidewire advancement device 48. In some embodiments, introducer needle 50 may extend through catheter 19 to facilitate insertion of catheter 19 into a blood vessel. In some embodiments, guidewire advancement device 48 may be configured to advance guidewire 62 distally and / or withdraw guidewire 62 proximally.

[0036] In some embodiments, removing the guidewire advancement device 48 from the catheter system 10 may be configured to withdraw the guidewire 62 and introducer needle 50 from the catheter system 10, for example, as shown in FIG. 1C. More specifically, in some embodiments, the guidewire 62 and introducer needle 50 may be withdrawn proximally together. In some embodiments, the guidewire 62 may be configured to remain on the protruding portion of the introducer needle 50 as the guidewire 62 and introducer needle 50 are withdrawn from the catheter system 10. This may reduce the risk of shearing the guidewire 62.

[0037] In some embodiments, guidewire advancement device 48 may include a slot 64 and an advancement tab 66 linearly movable along slot 64. In some embodiments, slot 64 may be disposed within housing 65. In some embodiments, advancement tab 66 may be configured to advance guidewire 62 distally and / or withdraw guidewire 62 proximally. In some embodiments, the longitudinal axis of guidewire advancement device 48 may be aligned with the longitudinal axis of the catheter assembly.

[0038] In some embodiments, guidewire 62 may facilitate advancement of catheter 19 within a blood vessel and / or removal of a thrombus or occlusion. In some embodiments, guidewire 62 may include a distal end 68 and a proximal end 70. In some embodiments, proximal end 70 may be coupled to advancement tab 66 and configured to be slid along slot 64 by a user's hand. In some embodiments, distal end 68 of guidewire 62 may be disposed within guidewire advancement device 48 and / or introducer needle 50 when advancement tab 66 is in the proximal position, as shown in FIG. 1B , for example. In these and other embodiments, guidewire 62 disposed within introducer needle 50 may facilitate guidance of guidewire 62 as it advances distally. In some embodiments, advancement tab 66 may be at the proximal end of slot 64 when advancement tab 66 is in the proximal position and / or at the distal end of slot 64 when advancement tab 66 is in the distal position. In some embodiments, advancement tab 66 may be slid from a proximal position to a distal position to move distal end 68 of guidewire 62 beyond the distal tip of catheter 19 and into the blood vessel.

[0039] In some embodiments, introducer needle 50 may include a sharp distal tip 72, a proximal end 60, and a lumen 76 extending through sharp distal tip 72 and proximal end 60. In some embodiments, guidewire 62 may be disposed within lumen 76 of introducer needle 50 and / or may be configured to move through introducer needle 50 for distal advancement. In these embodiments, proximal end 60 of introducer needle 50 may be generally cylindrical and / or uncrimped, which may facilitate movement of guidewire 62 therethrough.

[0040] 5A-5B, the V-clip needle shield 46 may include a first arm 82 and a second arm 84. In some embodiments, the first arm 82 may include an extension 86 that forms a claw 88 at the end of the extension 86. In some embodiments, the first arm 82 and / or the second arm 84 may also include a needle tip shield flap 90 that can stop the advancement of the sharp distal tip 72 after the V-clip needle shield 46 is engaged. In some embodiments, the needle tip shield flap 90 may be used to prevent the re-emergence of the sharp distal tip 72 from the safety housing 44 after the introducer needle 50 has been shielded by the safety housing 44.

[0041] In some embodiments, the pawl 88 may be formed of metal bent primarily at 90 degrees from the extension 86. However, in some embodiments, the pawl 88 may be bent at any other desired angle. In some embodiments, the pawl 88 may be bent from about 30 degrees to about 180 degrees relative to the extension 86. In some embodiments, the pawl 88 may be bent in any direction that allows the pawl 88 to engage with the catheter adapter 12. In some embodiments, the pawl 88 on the V-clip needle shield 46 may function to engage with a crescent-shaped groove 92 on the catheter adapter 12 (see, e.g., FIG. 5B). In some embodiments, the pawl 88 may engage with the groove 92 to prevent the safety housing 44 from separating from the catheter adapter 12 until the introducer needle 50 is withdrawn sufficiently to actuate the V-clip needle shield 46. FIG. 5B shows the pawl 88 separated from the groove 92, according to some embodiments.

[0042] In some embodiments, when the V-clip needle shield 46 is actuated (fired), the first arm 82 separates from the second arm 84 under the spring force of the elbow 94. In some embodiments, as the first arm 82 separates from the second arm 84, the pawl 88 moves from a first position to a second position. In some embodiments, when the pawl 88 is in its first position, it engages with a groove 92 on the catheter adapter 12. In some embodiments, after the pawl 88 moves from its first position to its second position, the pawl 88 moves from engagement with the groove 92 to a position disengaged from the groove 92.

[0043] In some embodiments, to prevent premature disengagement of the pawl 88 from the groove 92, the pawl 88 must be strong enough to avoid bending, moving, shifting, or other action that would cause the V-clip needle shield 46 to separate from the catheter adapter 12 before the introducer needle 50 has advanced sufficiently to activate or engage the V-clip needle shield 46. In some embodiments, the V-clip needle shield may include any suitable V-clip needle shield or may be further described in U.S. Patent No. 9,220,871, filed November 20, 2007, entitled "NEEDLESHIELDING PAWL STRUCTURES," which is incorporated herein by reference in its entirety.

[0044] 1A-1C , in some embodiments, the safety housing 44 may include an open space 96 adjacent and proximal to the V-clip needle shield 46. In some embodiments, the open space 96 may be provided in the direction of the axial or longitudinal axis of the catheter system 10. In some embodiments, the guidewire 62 may be configured to bend within the open space 96 when the V-clip needle shield 46 is fired, as shown, for example, in FIG. 1C . In some embodiments, as shown in FIGS. 1B-1C , for example, the width of the open space 96 may be equal to or greater than the width of the V-clip needle shield 46, which may allow the V-clip needle shield 46 to properly fire when the guidewire 62 is extended distally beyond the sharp distal tip 72. In some embodiments, the sharp distal tip 72 may include a bevel 98 facing toward the top of the catheter system 10, or in an upward direction 100 (see, for example, FIGS. 1B-1C ), and the V-clip needle shield 46 may be configured to fire left or right perpendicular to the upward direction 100. When the bevel 98 faces in an upward direction 100, the catheter system 10 is in an insertion position ready for insertion into a patient.

[0045] Referring now to FIG. 5C , in some embodiments, the sharp distal tip 72 may include a bevel 98 facing upward (directed out of the page), and the V-clip needle shield 46 may be configured to fire in the upward direction or in a downward direction opposite to the upward direction. The cross-sectional view in FIG. 5C is a top view showing the bottom of a catheter system configured closest to the patient, according to some embodiments. Thus, in some embodiments, the open space 96 may be provided perpendicular to the axial direction of the catheter system 10 or perpendicular to the direction of the longitudinal axis. In some embodiments, the introducer needle 50 may include a needle bump 102 (see, e.g., FIG. 2B ), which may prevent the introducer needle 50 from being removed proximally from the safety housing 44.

[0046] 1A-1C , in some embodiments, the proximal end 54 of the safety housing 44 may be removably coupled to the guidewire advancement device 48. In some embodiments, the introducer needle 50 may include a needle bump 102, which may capture a washer 104 having a hole with a smaller diameter than the needle bump 102. Thus, in some embodiments, when the guidewire advancement device 48 moves proximally to retract the introducer needle 50 proximally, the needle bump 102 does not pass through the hole and the sharp distal tip 72 may be retained within the safety housing 44, preventing an accidental needle stick. In some embodiments, the distal end 52 of the safety housing 44 may be removably coupled to the proximal end 16, and the distal end 52 of the safety housing 44 may be decoupled from the proximal end 16 when the sharp distal tip 72 is shielded within the safety housing 44.

[0047] In some embodiments, the guidewire 62 may be advanced distally via a particular guidewire advancing device, such as, for example, guidewire advancing device 48 of FIG. 1 , guidewire advancing device 106 of FIG. 2 , guidewire advancing device 165 of FIG. 8 , or another suitable guidewire advancing device. In some embodiments, the use of an integrated catheter system may facilitate separation of a particular guidewire advancing device with a fluid or blood collection path through the extension tube 20. In some embodiments, a particular guidewire advancing device may be detached from the catheter system 10 after use. In some embodiments, detaching a particular guidewire advancing device from the catheter system 10 may be configured to withdraw or remove the guidewire 62 and introducer needle 50 from the catheter system 10, and more specifically, from the catheter assembly. In some embodiments, the guidewire 62 may be configured to remain in the protruding portion of the introducer needle 50 when the guidewire 62 and introducer needle 50 are withdrawn from the catheter system 10.

[0048] In some embodiments, after removing a particular guidewire-advancing device from the catheter system 10, the catheter-advancing device may be coupled to the proximal port 36 and a secondary catheter may be advanced into the catheter assembly via the catheter-advancing device. In some embodiments, after removing a particular guidewire-advancing device from the catheter system 10, a probe-advancing device may be coupled to the proximal port and a probe of the probe-advancing device may be advanced into the catheter assembly. In some embodiments, the probe may include one or more sensors configured to measure one or more properties of the blood.

[0049] 2A-2D, in some embodiments, guidewire advancement device 106 may include a rotating element 107 configured to advance guidewire 62 distally and / or retract guidewire 62 proximally. In some embodiments, guidewire advancement device 106 may be similar or identical in one or more features and / or operation to guidewire advancement device 48 of FIGS. 1A-1C.

[0050] In some embodiments, guidewire advancement device 106 may include a housing 108 having a distal end 110 and a proximal end 112. In some embodiments, guidewire advancement device 106 may include a rotation element 107 that allows guidewire 62 to be advanced distally through the catheter assembly and / or subsequently withdrawn proximally. In some embodiments, compartment 114 may be formed within guidewire advancement device 106 and may house rotation element 107. In some embodiments, guidewire channel 116 may extend distally from compartment 114 and extend through distal end 110 of housing 108.

[0051] 2B-2C, in some embodiments, rotating element 107 can include an advancement wheel 124 that can include a spool for guidewire 62. Thus, in some embodiments, when advancement wheel 124 rotates, the rotation can advance or retract guidewire 62 within guidewire channel 116 depending on the direction advancement wheel 124 rotates.

[0052] As shown in FIG. 2D , in some embodiments, the rotating element 107 may include a spool 118 and an advancement wheel 124, both of which may be configured to rotate within the compartment 114. In some embodiments, the spool 118 may be positioned adjacent to the advancement wheel 124 (i.e., toward the guidewire channel 116 relative to the advancement wheel 124). In some embodiments, the advancement wheel 124 may be positioned to extend partially from the compartment 114, thereby allowing a user to rotate the advancement wheel 124 with their thumb or finger. In some embodiments, the spool 118 may include a gear 119 having teeth. Similarly, in some embodiments, the advancement wheel 124 may include teeth and thus function as a gear. In some embodiments, the teeth of the advancement wheel 124 may interface with the teeth of the gear 119 such that the spool 118 rotates as the advancement wheel 124 rotates.

[0053] In some embodiments, spool 118 and advancement wheel 124 may include shafts 120 and 121, respectively, on which these components are disposed within compartment 114 and about which these components rotate. In some embodiments, spool 118 may include a spool drum 122 on which guidewire 62 may be wound. Thus, as spool 118 rotates, the rotation may advance or retract guidewire 62 within guidewire channel 116, depending on the direction in which advancement wheel 124 rotates. In some embodiments, advancement wheel 124 may include or correspond to any other advancement wheel described in more detail in U.S. Patent Application No. 17 / 709,935, filed March 31, 2022, entitled "INSTRUMENT DELIVERY DEVICES, SYSTEMS, AND METHODS," which is incorporated herein by reference in its entirety.

[0054] 3A-3B, in some embodiments, introducer needle 50 may include an external groove 126. In some embodiments, guidewire 62 may be disposed within external groove 126 and configured to travel through external groove 126 to be advanced distally and / or withdrawn proximally. In these and other embodiments, guidewire advancement device 48 of FIGS. 1A-1C or guidewire advancement device 106 of FIGS. 2A-2D may be used with introducer needle 50 to advance and / or withdraw guidewire 62 through external groove 126. In some embodiments, external groove 126 may extend along the entire length of introducer needle 50 from sharp distal tip 72 to proximal end 60, which may facilitate advancement of guidewire 62 along the entire length of introducer needle 50. In some embodiments, a particular guidewire advancement device may be coupled to proximal end 16 of catheter adapter 12, and guidewire 62 may be inserted straight through catheter adapter 12 and catheter 19 within external groove 126.

[0055] 4A-4B, in some embodiments, introducer needle 50 can include an opening 128 disposed between sharp distal tip 72 and proximal end 60 of introducer needle 50. In some embodiments, guidewire 62 can be configured to extend from sharp distal tip 72 of introducer needle 50 through extension tube 20, side port 18, and opening 128. In these and other embodiments, guidewire advancement device 48 of FIGS. 1A-1C or guidewire advancement device 106 of FIGS. 2A-2D can be coupled to proximal port 36 to advance and / or withdraw guidewire 62 through opening 128 and catheter 19.

[0056] 4C , in some embodiments, the proximal end 30 of the second extension tube 26 may be integrated with the adapter 130, which may reduce the risk of fluid exposure to the user. More specifically, in some embodiments, the proximal end 30 of the second extension tube 26 may be permanently or permanently coupled to the adapter 130, for example, via adhesive, bonding, a non-luer coupling, or other suitable permanent or permanent coupling. In some embodiments, the adapter 130 may be coupled to a needleless connector, which may reduce the risk of bacterial contamination. In some embodiments, the proximal end 132 of the adapter 130 may include a single port or dual ports.

[0057] In some embodiments, the catheter system 10 may include a flash chamber 134 that may be disposed within a plug 136 coupled to the adapter 130 to facilitate visualization of blood flashback. In some embodiments, the proximal end 138 of the flash chamber 134 may be closed, and the flash chamber 134 may include a vent port 140 distal to the proximal end 138 of the flash chamber 134. In some embodiments, the vent port 140 may be configured to allow air but not blood to pass through. In some embodiments, the vent port 140 may be disposed at the distal end of the flash chamber 134, which may maintain some unvented air within the flash chamber 134 to provide visualization of the arterial pulse, thereby providing continuous visual confirmation of adequate arterial access.

[0058] 6A-6C, the needle safety element may include an introducer needle capture mechanism 141 that may allow the introducer needle 50 to move from an unshielded position (see, e.g., FIG. 6A ), in which the introducer needle 50 is prevented from moving distally from the capture mechanism 141, to a shielded position (see, e.g., FIG. 6B ). In some embodiments, the introducer needle 50 may be captured in both directions and also prevented from moving proximally from the capture mechanism 141. In some embodiments, the introducer needle 50 may be captured in both directions and also prevented from moving proximally from the capture mechanism 141. As used herein, the term “unshielded” may refer to a situation in which the sharp distal tip 72 of the introducer needle 50 is exposed from the internal housing of the capture mechanism 141. Conversely, the term “shielded” may refer to a situation in which the sharp distal tip 72 of the introducer needle 50 is covered, shielded, or otherwise protected by the internal housing of the capture mechanism 141. In some embodiments, capture mechanism 141 allows introducer needle 50 to be locked in a shielded position, so that capture mechanism 141 can prevent unintentional attachment and / or blood exposure.

[0059] In some embodiments, introducer needle capture mechanism 141 may include introducer needle 50 (e.g., introducer needle 50), needle bump 102, inner housing 142, and outer housing 144. Further, in some embodiments, capture mechanism 141 may be selectively coupled to catheter adapter 12. In some embodiments, introducer needle 50 is exposed from inner housing 142 in the unshielded position, and introducer needle 50 may extend axially through inner housing 142 and outer housing 144 such that sharp distal tip 72 extends through distal end 146 of inner housing 142 and distal end 147 of outer housing 144. Further, in the unshielded position, a distal portion of introducer needle 50 may extend within catheter 19, and outer housing 144 may be coupled to catheter adapter 12.

[0060] In some embodiments, the inner housing 142 may be split longitudinally to form multiple arms 148. The inner housing 142 may include any number of arms, for example, two, three, or four. In some embodiments, the arms 148 may extend distally from a proximal portion, such as the proximal end, of the inner housing 142. In some embodiments, the introducer needle 50 may be configured to bias the arms 148 apart when the introducer needle 50 is exposed from the distal end 146 of the inner housing 142. For example, in some embodiments, when the introducer needle 50 is exposed from the distal end 146 of the inner housing 142 in the unshielded position, the arms 148 of the inner housing 142 may be resiliently spread radially outward by the introducer needle 50, as shown in FIG. 6A , for example.

[0061] In some embodiments, inner housing 142 may be constructed of any suitable material, such as, for example, a metal, a metal alloy, a ceramic, a plastic, a polymer, etc. Advantageously, a rigid plastic may allow sharp distal tip 72 to be embedded in the interior surface of inner housing 142 when in the shielded position. In some embodiments, inner housing 142 may be a single piece. In some embodiments, inner housing 142 may include multiple pieces that may be joined together in any number of ways, such as, for example, by threading, attaching, snapping, connecting, gluing, fastening, clipping, hooking, or any other suitable joining means.

[0062] In some embodiments, when introducer needle 50 is retracted proximally within inner housing 142 to the shielded position, outer housing 144 can be configured to move from a compressed state, shown in FIG. 6A , to a decompressed state, shown in FIG. 6B . In some embodiments, when outer housing 144 is in the decompressed state, outer housing 144 can bias arms 148 of inner housing 142 together, which can securely seal or close distal end 146 of inner housing 142 and prevent introducer needle 50 from exiting distal end 146 of inner housing 142.

[0063] In some embodiments, when outer housing 144 is decompressed or moved from, for example, a compressed state shown in FIG. 2A to, for example, a decompressed state shown in FIG. 2B , outer housing 144 may slide or expand axially over at least a portion of inner housing 142. The portion of inner housing 142 over which outer housing 144 slides or expands can have any suitable size or any suitable shape. For example, the portion of inner housing 142 may be substantially cylindrical, cubical, tubular, etc. A distal restoring force may cause outer housing 144 to slide or expand axially as outer housing 144 moves from a compressed state to a decompressed state.

[0064] In some embodiments, outer housing 144 may include a compressible portion 150, which may be disposed between and / or coupled to distal end 147 of outer housing 144 and proximal end 152 of outer housing 144. In some embodiments, compressible portion 150 of outer housing 144 may be compressed when outer housing 144 is in a compressed state and decompressed when outer housing 144 is in a decompressed state. In some embodiments, compressible portion 150 may be compressible along an axis aligned with introducer needle 50. In some embodiments, compressible portion 150 may include a spring, elastomer, or another compressible member. In some embodiments, compressible portion 150 may be cylindrical. In some embodiments, the spring may be cylindrical and / or coiled. In some embodiments, compressible portion 150 may be baffle- or accordion-shaped. In these and other embodiments, compressible portion 150 may include a tube or sleeve, which may be constructed of an elastomer, silicone, liquid silicone rubber material, or another suitable material. In some embodiments, the compressible portion 150 may surround an inner housing 142 which may act as a redundant mechanism to ensure that any residual blood on the introducer needle 50 remains within the introducer needle capture mechanism 141.

[0065] In some embodiments, the proximal end 152 of the outer housing 144 may be directly coupled to the proximal end of the inner housing 142, and the distal end 147 of the outer housing 144 may move distally from the proximal end of the outer housing 144 and the proximal end of the inner housing 142 when the outer housing 144 moves to the decompressed state. In some embodiments, the movement of the outer housing 144 to the decompressed state may cause the distal end 147 of the outer housing 144, which may be radially rigid and / or coupled to the compressible portion 150, to slide or move distally along the inner housing 142.

[0066] In some embodiments, the inner surface of the catheter adapter 12 can be configured to secure the inner housing 142 within the catheter adapter 12 when the introducer needle 50 is exposed from the inner housing 142. In some embodiments, the inner surface of the catheter adapter 12 can be configured to separate from the inner housing 142 to release the inner housing 142 from the catheter adapter when the introducer needle 50 is retracted proximally within the inner housing 142, as shown in FIG. 6B . More specifically, in some embodiments, the outer surface of the inner housing can include one or more interlocking components 154 that can interact with one or more interlocking surfaces 156 formed on the inner surface of the catheter adapter 12. In some embodiments, the interlocking components 154 can be biased against corresponding interlocking surfaces 156 of the catheter adapter 12 when the introducer needle 50 is exposed from the distal end 146 of the inner housing 142 in the unshielded position. In some embodiments, in response to proximal retraction of introducer needle 50 within inner housing 142, radially inward contraction of inner housing 142 may cause one or more interlocking components 154 to separate from one or more interlocking surfaces 156, which may allow introducer needle capture mechanism 141 to be removed from catheter adapter 12, with sharp distal tip 72 of introducer needle 50 shielded inside inner housing 142. Thus, an unintentional needle stick may be prevented and introducer needle capture mechanism 141 may be safely deployed.

[0067] In some embodiments, when the introducer needle 50 is retracted to a proximally shielded position within the inner housing 142, the guidewire 62 may not be retracted, leaving the introducer needle 50 protruding, for example, as shown in FIG. 6B . | In some embodiments, when the outer housing 144 is in a depressurized state, the outer housing 144 may bias the arms 148 of the inner housing 142 together, which may securely seal or close the distal end 146 of the inner housing 142 around the guidewire 62. In some embodiments, when the outer housing 144 is in a depressurized state, the outer housing 144 may bias the arms 148 of the inner housing 142 together, which may pinch the guidewire 62, which may strengthen the seal around the guidewire 62 and / or facilitate removal of the guidewire 62 by the introducer needle 50. In some embodiments, after the introducer needle is shielded within the inner housing 142, the guidewire 62 and introducer needle 50 may be withdrawn proximally together and removed from the catheter system 10. In some embodiments, further details of the needle capture mechanism 141 may be further described in patent document 3, U.S. Patent No. 10,507,281, filed March 16, 2017, entitled "CANNULA CAPTURE MECHANISM," which is incorporated herein by reference in its entirety.

[0068] Referring now to FIG. 7, another type of spring clip, a cross-arm clip 158, is shown, according to some embodiments. In some embodiments, the V-clip needle shield 46 of FIGS. 2B-2C and 1B-1C may be replaced with the cross-arm clip 158 or another suitable spring clip or needle safety element. In these embodiments, the cross-arm clip 158 may be disposed within the safety housing 44. In other embodiments, the cross-arm clip 158 may be disposed within a catheter adapter, such as, for example, another suitable catheter adapter, such as the catheter adapter 12 of FIG. 1. In some embodiments, the cross-arm clip 158 may include a resilient first arm 160 and a resilient second arm 162 configured to cross one another. In some embodiments, the proximal ends of the first arm 160 and the second arm 162 may be joined at a proximal wall, which may include an opening sized and configured to slidably receive the proximal end of the introducer needle 50 as the introducer needle 50 is advanced distally. In some embodiments, the needle feature or ridge (not shown) may prevent the sharp distal tip 72 of the introducer needle 50 from being withdrawn proximally through the opening because the diameter of the needle feature or ridge may be larger than the diameter of the opening.

[0069] In some embodiments, the distal ends of the first arm 160 and the second arm 162 may be curved and / or include a lip. In some embodiments, when the introducer needle 50 is in the insertion position and ready for insertion into the patient, the introducer needle 50 may be disposed between the distal ends of the first arm 160 and the second arm 162 and bias the first arm 160 and the second arm 162 outward. In some embodiments, when the first and second arms 160, 162 are biased outward, they may engage with an inner wall of the catheter adapter or the inner wall of the safety housing 44, securing the cross-arm clip 158 within the catheter adapter or the safety housing 44. In response to withdrawal of the introducer needle 50 from the patient and movement of the sharp distal tip 72 adjacent the distal ends of the first and second arms 160, 162, the distal ends of the first and second arms 160, 162 may move toward one another and / or overlap, which may disengage the cross-arm clip 158 from the catheter adapter or safety housing 44 and prevent the introducer needle 50 from moving distally beyond the cross-arm clip 158, as illustrated, for example, in FIG. 7 .

[0070] In some embodiments, the cross-arm clip 158 may not be modified relative to the guidewire 62 and / or may include a clip further described in U.S. Patent No. 7,972,313, filed November 22, 2006, entitled "Spring Clip Safety IVCather," which is incorporated herein by reference in its entirety. In some embodiments, the distal end of the first arm 160 and / or the distal end of the second arm 162 may include an opening 164 sized and configured to receive the guidewire 62. In some embodiments, the diameter of the opening may be smaller than the diameter of the introducer needle 50, which may prevent the introducer needle 50 from moving distally through the opening in the shielded position. In some embodiments, the cross-arm clip 158 may be further described in U.S. Patent No. 11,291,803, filed January 3, 2019, entitled "Catherine System with Guidewire Advancement Element," which is incorporated herein by reference in its entirety.

[0071] 8A-8B, in some embodiments, guidewire advancement device 165 may include rack 166 and pinion 168. In some embodiments, advancement tab 66 may include rack 166. In some embodiments, advancement tab 66 may be similar to or identical to advancement tab 66 of FIGS. 1-2 in one or more features and / or operation relative to slot 64. In some embodiments, guidewire advancement device 165 may be similar to or identical to guidewire advancement device 48 and / or guidewire advancement device 106 in one or more features and / or operation. In some embodiments, pinion 168 may include a spool for guidewire 62. Thus, when rack 166 moves to rotate pinion 168, the rotation may advance or retract guidewire 62 depending on the direction rack 166 moves and pinion 168 rotates.

[0072] 9A-9H, a catheter system 200 is shown, according to some embodiments. In some embodiments, the catheter system 200 may be similar to or identical to those of FIGS. 1-8 in terms of one or more components and / or operation. In some embodiments, the catheter system 200 may include a catheter adapter 202, which may include a distal end 204, a proximal end 206, and a lumen extending through the distal end 204 of the catheter adapter 202 and the proximal end 206 of the catheter adapter. In some embodiments, the catheter system 200 may include a catheter 209 extending from the distal end 204 of the catheter adapter 202.

[0073] In some embodiments, the catheter system 200 may include a guidewire advancement device 220 coupled to the catheter adapter 202. In some embodiments, the guidewire advancement device 220 may include a casing 222, a guidewire 224 at least partially disposed within the casing 222, and a roller wheel element 226 extending through the casing 222 and contacting the guidewire 224. In some embodiments, the guidewire 224 may be configured to advance distally in response to rotation of the roller wheel element 226 in a direction 228 toward the proximal or proximal end 230 of the casing 222. In these embodiments, the roller wheel element 226 may slightly pinch or compress the guidewire 224 as the roller wheel element 226 rotates or turns on its central axis, which may facilitate advancement of the guidewire 224.

[0074] In some embodiments, the catheter system 200 may include an introducer needle 232 that may include a proximal end 234 and a sharp distal tip 236. In some embodiments, a removable cover 237 may be placed over the sharp distal tip 236 to prevent accidental needle sticks. In some embodiments, the proximal end 234 of the introducer needle 232 may be secured within the guidewire advancement device 220. In some embodiments, the introducer needle 232 may extend through the catheter 219, and the guidewire 224 may be configured to move through the introducer needle 232 when the guidewire 224 is advanced distally.

[0075] In some embodiments, catheter system 200 may include a platform 238 disposed within casing 222 and beneath roller wheel element 226. In some embodiments, platform 238 may contact and support guidewire 224. In some embodiments, platform 238 may include linear groove 240. In some embodiments, guidewire 224 may be disposed within linear groove 240, which may facilitate guiding guidewire 224 during distal advancement of guidewire 224. In some embodiments, platform 238 may be generally planar.

[0076] In some embodiments, the catheter system 200 may include opposing roller wheel support grooves 242 a, 242 b disposed within the casing 222. In some embodiments, the roller wheel element 226 may include opposing pins 244 a, 244 b fixed relative to the circular body of the roller wheel element 226. In some embodiments, the opposing pins 244 a, 244 b may be configured to rotate within the opposing roller wheel support grooves 242 a, 242 b. In other embodiments, the circular body may rotate on an axis. In some embodiments, the circular body may extend through a slot 245 in the casing 222 and may be configured to be easily rotated by a user's fingers.

[0077] In some embodiments, the proximal end of guidewire 224 may be looped back on itself, coiled, or otherwise organized to facilitate distal movement and prevent tangling. In some embodiments, the proximal end of guidewire 224 may be disposed on the floor of casing 222 below platform 238. In some embodiments, in response to rotation of roller wheel element 226 in a direction 228 toward proximal or proximal end 230 of casing 222, guidewire 224 may be configured to advance distally, including through introducer needle 232 and catheter 209, and into the patient's vasculature.

[0078] In some embodiments, the distal end 246 of the casing 222 may include a male luer fitting 248, which may facilitate coupling to the catheter adapter 202 and / or a safety housing, such as, for example, the safety housing 44 of FIGS. 1-2. In some embodiments, the distal end 246 of the casing 222 may include another type of suitable connector. In some embodiments, the safety housing may include a needle safety element, such as, for example, the V-clip shield 46 described above or another suitable needle safety element.

[0079] In some embodiments, the catheter system 200 may include a septum 250 and a septum actuator 252 disposed within the lumen of the catheter adapter 202. In some embodiments, the septum actuator 252 may be used to open the septum 250 in response to engagement of an external connector or insertion of an external connector into the proximal end 206, such that the septum actuator 252 is moved distally through the septum 250, which may include a slit 251. In some embodiments, in response to removal of the external connector from the proximal end 206, the septum actuator 252 may return to a proximal position within the lumen and the septum 250 may close. In some embodiments, the septum 250 may help stop blood flow through the catheter adapter 202 when the catheter adapter 202 is not engaged with an external connector or extension set. In some embodiments, the fluid path through the catheter adapter 202 may be closed unless an external connector is engaged with the catheter adapter 202, such that the septum actuator 252 opens the septum 250.

[0080] In some embodiments, the user may remove the removable needle cover 237 and confirm that the guidewire 224 is inside the introducer needle 232. In some embodiments, the tip adhesive may be broken before inserting the introducer needle 232 and catheter 209 into the patient's skin. In some embodiments, after the introducer needle 232 and catheter 209 are inserted through the skin and into the blood vessel, blood flashback may be observed by the clinician in the flashback chamber of the catheter system 200 or through a notch in the introducer needle 232, allowing blood to flow between the introducer needle 232 and the catheter 209. In some embodiments, after the clinician observes blood flashback confirming entry of the introducer needle 232 into the blood vessel, the roller wheel element 226 may be rotated, moving the guidewire 224 through the introducer needle 232.

[0081] In some embodiments, after the guidewire 224 has been advanced through the introducer needle 232 and into the blood vessel, the catheter adapter 202 may be advanced distally to move the catheter 209 further into the blood vessel. In some embodiments, after the catheter 209 has been moved further into the blood vessel, the casing 222 is decoupled from the catheter adapter 202 and slowly moved proximally by the user to withdraw the introducer needle 232 and guidewire 224 from the catheter adapter 202 and catheter system 200. In some embodiments, the casing 222, introducer needle 232, and guidewire 224 may all be discarded in an appropriate sharps container.

[0082] 10A-10C, a catheter system 260 is shown. In some embodiments, the catheter system 260 may be similar to or identical to the catheter system 260 of FIGS. 1-9 in terms of one or more components and / or operation. In some embodiments, the catheter system 260 may include a guidewire advancement device 262 coupled to the catheter adapter 202. In some embodiments, the guidewire advancement device 262 may include a casing 264, a slot 266 in the casing 264, the guidewire 224, and an advancement tab 268 extending through the slot 266 and configured to move linearly along the slot 266 to advance the guidewire 224 distally. In some embodiments, the shape of the advancement tab 268 may facilitate smooth, supported movement through the lumen of the casing 264. In some embodiments, the guidewire 224 may be coupled to and extend distally from the advancement tab 268. In some embodiments, the slot 266 may include a snap mechanism 270 that may engage with the advancement tab 268 to prevent the advancement tab 268 from moving proximally after advancement, reducing the risk of shearing the guidewire 224 on the introducer needle 232.

[0083] All examples and conditional language incorporated herein are intended for educational purposes to aid the reader in understanding the concepts contributed by the inventors to further develop the present invention and the art, and should not be construed as being limited to such specifically incorporated examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the present invention.

Claims

1. 1. A catheter system comprising:

1. A catheter assembly comprising: a catheter adapter including a distal end, a proximal end, a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter, and a side port in fluid communication with the lumen between the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending from the distal end of the catheter adapter; and an extension tube including a distal end and a proximal end, the distal end of the extension tube being integral with the side port of the catheter adapter; 1. A needle assembly comprising: a needle safety element disposed within the safety housing; a guidewire advancement device including a distal end, a proximal end, and a guidewire; an introducer needle including a proximal end and a sharp distal tip, the proximal end of the introducer needle being coupled to the guidewire advancement device; The introducer needle extends through the catheter, and the needle safety element is configured to shield the sharp distal tip.

2. 10. The catheter system of claim 1, wherein removing the guidewire advancement device from the catheter system is configured to withdraw the guidewire and introducer needle from the catheter system, and the guidewire is configured to remain on the protruding portion of the introducer needle when the guidewire and introducer needle are withdrawn from the catheter system.

3. 10. The catheter system of claim 1, wherein the guidewire advancement device comprises a slot and an advancement tab linearly movable along the slot, the advancement tab configured to advance the guidewire, and wherein a longitudinal axis of the guidewire advancement device is aligned with a longitudinal axis of the catheter assembly.

4. The catheter system of claim 3 , wherein the guidewire advancement device includes a rack and pinion, and the advancement tab includes the rack.

5. The catheter system of claim 1 , wherein the guidewire advancement device includes a rotating element configured to advance the guidewire.

6. 10. The catheter system of claim 1, wherein the introducer needle includes a lumen extending through the sharp distal tip and the proximal end, and the guidewire is disposed within the lumen and configured to be advanced through the proximal end of the introducer needle.

7. 10. The catheter system of claim 1, wherein the introducer needle includes an exterior groove, and the guidewire is configured to be positioned within the exterior groove and to travel through the exterior groove for distal advancement.

8. 10. The catheter system of claim 1, further comprising a safety housing, the safety housing having a distal end and a proximal end, the distal end of the safety housing coupled to the proximal end of the catheter adapter, the needle safety element comprising a V-clip needle shield, the distal end of the guidewire advancement device coupled to the proximal end of the safety housing, the safety housing comprising open spaces proximal and adjacent to the V-clip needle shield, the guidewire configured to bend within the open spaces when the V-clip needle shield is fired.

9. 9. The catheter system of claim 8, wherein the introducer needle includes a sharp distal tip, a proximal end, and a lumen extending through the sharp distal tip and the proximal end, the sharp distal tip including an upwardly facing bevel, and the V-clip needle shield is configured to fire side to side.

10. further comprising a safety housing; 2. The catheter system of claim 1, wherein the safety housing includes a distal end and a proximal end, the distal end of the safety housing is coupled to the proximal end of the catheter adapter, the needle safety element includes a V-clip needle shield, the distal end of the guidewire advancement device is coupled to the proximal end of the safety housing, the introducer needle includes a sharp distal tip, a proximal end, and a lumen extending through the sharp distal tip and the proximal end, the sharp distal tip includes a bevel facing upward, and the V-clip needle shield is configured to fire upward or downward.

11. the extension tube is a first extension tube; an access connector including a distal port, a proximal port, and a lateral port between the distal port and the proximal port, the distal port and the proximal port being aligned with a longitudinal axis of the access connector, the lateral port being angled relative to the longitudinal axis, and the proximal end of the first extension tube being integral with the distal port of the access connector; 10. The catheter system of claim 1, further comprising: a second extension tube including a distal end and a proximal end, the distal end of the second extension tube being integral with the side port of the access connector, the first extension tube being shorter than the second extension tube, and the longitudinal axes of the access connector, the first extension tube, and the side port being aligned and configured to form a linear path.

12. 12. The catheter system of claim 11, further comprising: an adapter coupled to the proximal end of the second extension tube; a plug coupled to the adapter; a flash chamber disposed within the plug; and a vent port distal to the proximal end of the flash chamber, wherein the proximal end of the second extension tube is integral with the adapter, the proximal end of the flash chamber is closed, the vent port is configured to pass air but not blood, and the plug is configured to maintain unvented air in the proximal end of the flash chamber to facilitate visualization of an arterial pulse.

13. The catheter system of claim 11 , further comprising a catheter advancement device coupled to the proximal port.

14. 12. The catheter system of claim 11, wherein the introducer needle includes a sharp distal tip, a proximal end, a lumen extending through the sharp distal tip and the proximal end, and an opening disposed between the sharp distal tip and the proximal end, and the guidewire is configured to extend from the sharp distal tip of the introducer needle through the extension tube, the side port, and the opening.

15. The catheter system of claim 1 , wherein the needle safety element comprises a cross-arm clip.

16. 1. A method comprising: Inserting a catheter system into a patient's blood vessel, the catheter system comprising:

1. A catheter assembly comprising: a catheter adapter including a distal end, a proximal end, a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter, and a side port in fluid communication with the lumen between the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending from the distal end of the catheter adapter; and an extension tube including a distal end and a proximal end, the distal end of the extension tube being integral with the side port of the catheter adapter; 1. A needle assembly comprising: a needle safety element; a guidewire advancement device including a distal end, a proximal end, and a guidewire; an introducer needle including a proximal end, the proximal end of the introducer needle coupled to the guidewire advancement device, the introducer needle being a needle assembly extending through the catheter; advancing the guidewire distally after the catheter system is inserted into the blood vessel; and removing the guidewire advancing device from the catheter system after the guidewire has been advanced, wherein removing the guidewire advancing device from the catheter system withdraws the guidewire and introducer needle from the catheter system, and wherein the guidewire remains on the protruding portion of the introducer needle when the guidewire and introducer needle are withdrawn from the catheter system.

17. the extension tube is a first extension tube; The catheter system comprises: an access connector including a distal port, a proximal port, and a lateral port between the distal port and the proximal port, the distal port and the proximal port being aligned with a longitudinal axis of the access connector, the lateral port being angled relative to the longitudinal axis of the access connector, and the proximal end of the first extension tube being integral with the distal port of the access connector; 17. The method of claim 16, further comprising: a second extension tube including a distal end and a proximal end, the distal end of the second extension tube being integral with the side port of the access connector, and the first extension tube being shorter than the second extension tube.

18. removing the guidewire-advancing device from the catheter system, and then removing the guidewire-advancing device from the catheter system and withdrawing the guidewire and introducer needle from the catheter system; coupling a catheter advancement device to the proximal port and advancing a second catheter through the catheter advancement device and into the catheter assembly; 18. The method of claim 17, further comprising coupling a probe advancing device to the proximal port and advancing the probe advancing device through the probe advancing device and into the catheter assembly.

19. 17. The method of claim 16, wherein the needle safety element comprises a V-clip needle shield, a cross-arm clip, or an introducer needle capture mechanism.

20. 17. The method of claim 16, wherein the needle assembly further comprises a safety housing, the safety housing comprising a distal end and a proximal end, the distal end of the safety housing coupled to the proximal end of the catheter adapter, the needle safety element disposed within the safety housing, and the distal end of the guidewire advancement device coupled to the proximal end of the safety housing.

21. 1. A catheter system comprising: a catheter adapter including a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending from the distal end of the catheter adapter; a guidewire advancement device coupled to the catheter adapter, the guidewire advancement device including a casing, a guidewire at least partially disposed within the casing, and a roller wheel element extending through the casing and contacting the guidewire, the guidewire advancement device configured to advance the guidewire distally in response to proximal rotation of the roller wheel element; an introducer needle including a proximal end and a sharp distal tip, the proximal end secured within the guidewire advancement device, the introducer needle extending through the catheter.

22. 22. The catheter system of claim 21, further comprising a platform disposed within the casing and beneath the roller wheel element, the platform including a linear groove, and the guidewire disposed within the linear groove.

23. 22. The catheter system of claim 21, further comprising opposing roller wheel support grooves disposed within the casing, the roller wheel elements including opposing pins configured to rotate within the opposing support grooves.

24. 22. The catheter system of claim 21, wherein the distal end of the casing includes a male luer fitting.

25. 22. The catheter system of claim 21, further comprising a septum and a septum actuator disposed within the lumen of the catheter adapter.

26. 1. A catheter system comprising: a catheter adapter including a distal end, a proximal end, and a lumen extending through the distal end of the catheter adapter and the proximal end of the catheter adapter; a catheter extending from the distal end of the catheter adapter; a guidewire advancement device coupled to the catheter adapter, the guidewire advancement device including a casing, a slot in the casing, a guidewire, and an advancement tab extending through the slot and configured to move along the slot to distally advance the guidewire; an introducer needle including a proximal end and a sharp distal tip, the proximal end secured within the guidewire advancement device, the introducer needle extending through the catheter.

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