CN222110692U

CN222110692U - Catheter system

Info

Publication number: CN222110692U
Application number: CN202323093273.9U
Authority: CN
Inventors: S·R·伊萨克森; W·F·哈丁; R·L·桑德雷格; J·K·伯克霍兹; E·J·阿; M·巴拉穆鲁甘
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2022-11-16
Filing date: 2023-11-16
Publication date: 2024-12-06
Anticipated expiration: 2033-11-16
Also published as: JP2025538472A; EP4619068A2; WO2024107566A2; CN120225238A; WO2024107566A3

Abstract

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

Description

Catheter system

Technical Field

The present disclosure relates generally to medical devices. In some embodiments, the present disclosure relates to catheter systems.

Background

Arterial catheterization is an important procedure commonly used in hospital settings in severely injured and perioperative patients. It is estimated that over 800 tens of thousands of arterial catheters are placed annually in the united states. Arterial catheters can accurately measure blood pressure, as well as heart rate and pulse profile, to allow immediate identification of abnormal hemodynamic events and initiation of appropriate therapy. Arterial catheters also provide samples for blood gas analysis without the morbidity associated with repeated arterial punctures. However, current arterial catheter use may result in significant blood leakage during insertion into a patient's artery, which may endanger the user. Furthermore, current arterial catheters may be difficult to use with a stylet or catheter advancing device.

The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is provided only to illustrate one example area of technology in which some of the embodiments described herein may be practiced.

Disclosure of utility model

The present disclosure relates generally to vascular access devices, systems, and methods. In particular, the present disclosure relates to a catheter system, and related devices and methods. In some embodiments, the catheter system may be configured for blood sampling, such as arterial blood sampling, for example. In some embodiments, the catheter system may be configured for blood pressure monitoring and/or blood gas sampling. Importantly, in some embodiments, the catheter system may provide near-patient access for more accurate hemodynamic measurements and improved delivery of instruments such as secondary catheters and/or probes into blood vessels, which may include arteries or veins. In some embodiments, the catheter system may include a guidewire for improving the success rate of catheterization. In some embodiments, the catheter system may reduce blood exposure when the catheter is inserted into an artery of a patient.

In some embodiments, the catheter system may include a catheter assembly. In some embodiments, the catheter assembly may include a catheter adapter that may include 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. In some embodiments, the catheter adapter may further include a side port between the distal end of the catheter adapter and the proximal end of the catheter adapter and in fluid communication with the lumen. In some embodiments, the catheter assembly may include a catheter extending from a distal end of the catheter adapter.

In some embodiments, the catheter assembly may include an extension tube, which may include a distal end and a proximal end. In some embodiments, the distal end of the extension tube may be integral with the 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 include a distal end and a proximal end. In some embodiments, the catheter system may include an access connector that may be configured to provide near patient access. In some embodiments, the access connector may include a distal port, a proximal port, and a side port between the distal port and the proximal port. In some embodiments, the distal port and the proximal port may be aligned with a longitudinal axis of the access connector. In some embodiments, the side port may be angled with respect to a longitudinal axis of the access connector. In some embodiments, the proximal end of the first extension tube may be integral with the distal port of the access connector.

In some embodiments, the distal end of the second extension tube may be integral with a 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 the secondary catheter and/or stylet through the first extension tube. In some embodiments, the longitudinal axis of the access connector, the first extension tube, and the side port may be configured to align to form a straight path, which may facilitate advancement of the secondary catheter and/or stylet within the catheter system. In some embodiments, the first extension tube may be rigid or semi-rigid, which may facilitate advancement of the secondary catheter and/or sensor through the first extension tube.

In some embodiments, the proximal port may include a female luer that may facilitate coupling the catheter advancement device to the access connector. In some embodiments, the proximal port may include another suitable connector. In some embodiments, a catheter advancement device may be coupled to the proximal port. In some embodiments, the catheter advancement device may comprise PIVO (trademark) needleless blood collection device available from becton, diskinson company of franklin lake, new jersey, or another suitable catheter advancement device. In some embodiments, the catheter advancement device may comprise a blood sampling device.

In some embodiments, the catheter system may include a needle assembly, which may include one or more of a safety housing, a guidewire advancement device, and an introducer needle. The active safety mechanism (e.g., push button) requires the user to activate the active safety mechanism, while the passive safety mechanism is automatically activated during normal use of the catheter system (e.g., withdrawal of the introducer needle). In some embodiments, the catheter system may include a needle safety element configured to shield the sharp distal tip of the introducer 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 a introducer needle. In some embodiments, the needle safety element may be disposed within the safety housing or within the catheter adapter. In some embodiments, a needle safety element disposed within the safety housing may protect a user from splatter of blood that may flow from the sharp distal tip of the introducer needle and may also shield 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 safety housing may be coupled to the proximal end of the catheter adapter.

In some embodiments, the guidewire advancing device may include a distal end and a proximal end. In some embodiments, the distal end of the guidewire advancement device can be coupled to the proximal end of the safety housing. In some embodiments without a safety housing, the distal end of the guidewire advancing device may be coupled to the proximal end of the catheter adapter. In some embodiments, the proximal end of the introducer needle can be coupled to a 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 protruding from the introducer needle as the guidewire and introducer needle are withdrawn from the catheter system.

In some embodiments, the guidewire advancement device can include a slot and an advancement tab that is linearly movable along the slot. In some embodiments, the advancement boss may be configured to distally advance the guidewire and/or proximally withdraw the guidewire. In some embodiments, the longitudinal axis of the guidewire advancement device can be aligned with the longitudinal axis of the catheter assembly. In some embodiments, the guidewire advancing device may include a rack and pinion. In some embodiments, the propulsion boss may include a rack. In some embodiments, the guidewire advancing device may include a rotating element configured to distally advance the guidewire and/or proximally retract the guidewire.

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

In some embodiments, the safety housing may include an open space proximal to 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 upwardly facing bevel, and the V-clip needle shield may be configured to fire from side to side. In some embodiments, the sharp distal tip may include an upwardly facing bevel, and the V-clip needle shield may be configured to fire in an upward or downward direction.

In some embodiments, the introducer needle can include an aperture disposed between the sharp distal tip and the proximal end of the introducer needle. In some embodiments, the guidewire may be configured to extend through the extension tube, side port, and aperture and out the sharp distal tip of the introducer needle.

In some embodiments, the proximal end of the second extension tube may be integral 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 comprise a single port or a dual port.

In some embodiments, a method may include inserting a catheter system into a blood vessel of a patient. In some embodiments, the blood vessel may comprise an artery. In some embodiments, the catheter system may be inserted into a blood vessel by piercing the skin and the blood vessel with a introducer needle and positioning the catheter within the blood vessel. In some embodiments, the method may include distally advancing the guidewire via the guidewire advancement device after inserting the catheter system into the vessel. In some embodiments, after distally advancing the guidewire, the method may include removing the guidewire advancing device from the catheter system. In some embodiments, removal of the guidewire advancement device from the catheter system withdraws the guidewire and introducer needle from the catheter system. In some embodiments, the guidewire may remain protruding from the introducer needle as the guidewire and introducer needle are withdrawn from the catheter system.

In some embodiments, the method may include, after removing the guidewire advancement device from the catheter system, coupling the catheter advancement device to the proximal port and advancing the secondary catheter into the catheter assembly via the catheter advancement device. In some embodiments, the method may include coupling a stylet propulsion device to the proximal port after removing the guidewire propulsion device from the catheter system, and propelling a stylet of the stylet propulsion 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.

According to another set of embodiments, a catheter system may include a catheter adapter, which may include 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. In some embodiments, the catheter system may include a catheter extending from a distal end of the catheter adapter. In some embodiments, the catheter system may include a guidewire advancing device coupled to the catheter adapter. In some embodiments, a guidewire advancement device can include a housing, a guidewire disposed at least partially within the housing, and a roller element extending through the housing and contacting the guidewire. In some embodiments, the guidewire may be configured to advance distally in response to rotation of the roller element in the proximal direction. In some embodiments, the catheter system may include an introducer needle, which 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.

In some embodiments, the catheter system may include a platform disposed within the housing and below the roller element. In some embodiments, the platform may include a linear groove. In some embodiments, the guidewire may be disposed within a linear groove, which may facilitate guiding of the guidewire during distal advancement of the guidewire. In some embodiments, the catheter system may include opposing roller support grooves disposed within the housing. In some embodiments, the roller element includes opposing pins configured to rotate within opposing support grooves.

In some embodiments, the distal end of the housing may include a male luer fitting, which may facilitate coupling to the catheter adapter and/or the safety housing. In some embodiments, the catheter system may include a septum and a septum actuator disposed in a lumen of the catheter adapter. In some embodiments, the septum may help prevent blood from flowing 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 the external connector is engaged with the catheter adapter such that the septum actuator opens the septum.

According to another set of embodiments, a guidewire advancement device coupled to a catheter adapter can include a housing, a slot within the housing, a guidewire, and an advancement tab extending through the slot and configured to move along the slot to distally advance the guidewire.

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 utility model, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It is also to be understood that these embodiments may be combined, or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the present utility model, unless so claimed. The following detailed description is, therefore, not to be taken in a limiting sense.

Drawings

Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

FIG. 1A is an upper perspective view of an example catheter system illustrating an example linear guidewire advancement device, according to some embodiments;

FIG. 1B is a cross-sectional view of a catheter system, illustrating an example push tab in an example proximal position, according to some embodiments;

FIG. 1C is a cross-sectional view of a catheter system, illustrating a pusher tab in an example distal position, according to some embodiments;

FIG. 2A is an upper perspective view of a catheter system illustrating an example rotary guidewire advancement device in accordance with some embodiments;

FIG. 2B is a cross-sectional view of a catheter system illustrating an example rotating element in a first position, according to some embodiments;

FIG. 2C is a cross-sectional view of a catheter system illustrating a rotating element rotated to a second position, in accordance with some embodiments;

fig. 2D provides an exploded rear view of a separate rotating element, according to some embodiments.

FIG. 3A is an upper perspective view of an example introducer needle with a notch in accordance with some embodiments;

FIG. 3B is a cross-sectional view of an introducer needle according to some embodiments;

FIG. 4A is an upper perspective view of an introducer needle having an example aperture and a guidewire extending through the aperture according to some embodiments;

FIG. 4B is a partial cross-sectional view of a catheter system illustrating an introducer needle having an aperture according to some embodiments;

FIG. 4C is a cross-sectional view of an example adapter according to some embodiments;

FIG. 5A is an upper perspective view of an example V-clip needle shield according to some embodiments;

FIG. 5B is a cross-sectional view of a V-clip needle shield separated from an example catheter adapter groove, according to some embodiments;

FIG. 5C is a cross-sectional view of a catheter system illustrating proximal withdrawal of an introducer needle into an example safety housing prior to separation of the safety housing from the example catheter adapter, in accordance with some embodiments;

FIG. 6A is a partial cross-sectional view of a catheter system illustrating an example restraint mechanism with an introducer needle exposed from a distal end of an example inner housing, according to some embodiments;

FIG. 6B is a partial cross-sectional view of a catheter system illustrating a constraining mechanism with the introducer needle retracted into the inner housing according to some embodiments;

FIG. 6C is a partial cross-sectional view of a catheter system illustrating removal of a restraint mechanism from a catheter adapter according to some embodiments;

FIG. 7 is an upper perspective view of an example spring clip in which a guide needle is shielded, according to some embodiments;

FIG. 8A is a cross-sectional view of an example pinion and an example advancement lobe having an example rack, illustrating the advancement lobe in a first proximal position, in accordance with some embodiments;

FIG. 8B is a cross-sectional view of a pinion and a push tab with an example rack, illustrating the push tab in an example second distal position, in accordance with some embodiments;

FIG. 9A is a side view of another example catheter system according to some embodiments;

FIG. 9B is a cross-sectional view of the catheter system of FIG. 9 according to some embodiments;

FIG. 9C is another cross-sectional view of the catheter system of FIG. 9 transverse to the cross-sectional view of FIG. 9B, according to some embodiments;

FIG. 9D is an upper perspective view of the catheter system of FIG. 9, illustrating an example housing in an open position, according to some embodiments;

FIG. 9E is an upper perspective view of an example diaphragm actuator according to some embodiments;

FIG. 9F is an upper perspective view of an example diaphragm according to some embodiments;

FIG. 9G is an upper perspective view of an example roller element disposed within an example opposing support groove, according to some embodiments;

FIG. 9H is an upper perspective view of a roller element disposed within an opposing support groove, according to some embodiments;

FIG. 10A is an upper perspective view of another catheter system illustrating an example push tab in an example proximal position, in accordance with some embodiments;

FIG. 10B is an upper perspective view of a push tab coupled to an example guidewire, according to some embodiments;

Fig. 10C is an upper perspective view of the catheter system of fig. 10A, illustrating the pusher tab in an example distal position, according to some embodiments.

Detailed Description

Referring now to fig. 1A-1C, a catheter system 10 is illustrated, according to some embodiments. In some embodiments, catheter system 10 may be configured for blood sampling, such as arterial blood sampling, for example. 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 near-patient access for more accurate hemodynamic measurements and improved delivery of instruments such as secondary catheters and/or probes into blood vessels, which may include arteries or veins. In some embodiments, the secondary catheter may include another catheter configured to extend through catheter 19 to extend the life of catheter 19, and the secondary catheter may be used for blood withdrawal and/or infusion.

In some embodiments, the catheter system 10 or one or more of the catheter systems of fig. 1-8 may be referred to as an "integrated" catheter system, meaning that the catheter system includes an extension tubing (e.g., an extension kit) that provides a fluid pathway to the catheter. In some embodiments, catheter system 10 may be similar to NEXIVA (trade mark) closed intravenous catheter system, NEXIVA (trade mark) DIFFUSICS (trade mark) closed intravenous catheter system, or PEGASUS ^{( Trade mark )} safety closed intravenous catheter system (both commercially available from becton-diskinson corporation of franklin lake, new jersey) or another suitable integrated catheter system in terms of one or more components and/or operations.

In some embodiments, catheter system 10 may include an arterial catheter system configured for insertion into an artery. In these embodiments, catheter system 10 may include significant improvements over existing arterial catheter systems by significantly reducing blood exposure and risk of infection and/or providing improved arterial access confirmation to the user, thereby improving the overall patient experience. Some existing arterial catheter systems, such as, for example, teleflex ARROW ^{( Registered trademark )} integrated arterial catheters, may not provide effective arterial blood control, which may result in placement procedures with significant blood exposure risk, infection risk, cleanup costs, and poor patient experience. Teleflex ARROW ^{( Registered trademark )} the integrated arterial catheter includes a non-rigid slotted tube from which a significant amount of blood may leak, endangering the user.

Catheter system 10 may include one or more of arterial blood sampling to reduce blood exposure, blood pressure monitoring, blood gas sampling, near patient access to use a secondary catheter and/or probe, blood control configured to operate under arterial pressure, a guidewire, and magnetic introducer needle guidance techniques, which may provide advantages over the prior art.

As illustrated in fig. 1A-1C, in some embodiments, the catheter system 10 may include a catheter assembly, which may include a catheter adapter 12, the catheter adapter 12 may include a distal end 14, a proximal end 16, a lumen extending through the distal end 14 of the catheter adapter 12 and the proximal end 16 of the catheter adapter 12. In some embodiments, the catheter adapter 12 may further include a side port 18, the side port 18 being between the distal end 14 of the catheter adapter 12 and the proximal end 16 of the catheter adapter 12 and 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, catheter 19 may comprise an arterial catheter, a peripherally inserted central catheter, a midline catheter, a peripherally intravenous catheter, or another suitable catheter.

In some embodiments, the catheter assembly may include an extension tube 20, and the extension tube 20 may include a distal end 22 and a proximal end 24. In some embodiments, the distal end 22 of the extension tube 20 may be integral with the side port 18 of the catheter adapter 12, which may reduce the risk of fluid exposure to the user. In more detail, in some embodiments, the distal end 22 of the extension tube 20 may be permanently or non-removably coupled to the side port 18 of the catheter adapter 12, such as, for example, via an adhesive, a bond, a non-luer coupling, or another suitable permanent or non-removable coupling.

In some embodiments, extension tube 20 may be a first extension tube. In some embodiments, the catheter system 10 may include a second extension tube 26, and the second extension tube 26 may include a distal end 28 and a proximal end 30. In some embodiments, catheter system 10 may include an access connector 32, which access connector 32 may be configured to provide near-patient access to one or more of a blood sample, 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 32. In some embodiments, the side ports 38 may be angled with respect to a 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. In more detail, 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, such as, for example, by an adhesive, a bond, a non-luer coupling, or another suitable permanent or non-removable coupling.

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. In more detail, 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, such as, for example, via an adhesive, a bond, a non-luer coupling, or another suitable permanent or non-removable coupling. In some embodiments, extension tube 20 may be shorter to facilitate near patient access. 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 stylet through the extension tube 20 and the proximal port 36. In some embodiments, the longitudinal axis 40 of the access connector 32, extension tube 20, and side port 18 may be configured to align to form a straight path, which may facilitate advancement of the secondary catheter and/or stylet within the catheter system 10. In some embodiments, the extension tube 20 may be rigid or semi-rigid, which may facilitate advancement of the secondary catheter and/or stylet through the extension tube 20.

In some embodiments, proximal port 36 may include a female luer that may facilitate coupling the catheter advancement device to access connector 32. In some embodiments, 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 comprise PIVO (trademark) needleless blood collection device available from becton, diskinson company of franklin lake, new jersey, or another suitable catheter advancement device. In some embodiments, the catheter advancement device may comprise a blood sampling device.

In some embodiments, catheter system 10 may include a needle assembly 42, and needle assembly 42 may include one or more of a safety housing 44, a V-clip needle shield 46 disposed within 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 safety housing 44 may be coupled to the proximal end 16 of the catheter adapter 12.

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

In some embodiments, removal of the guidewire advancement device 48 from the catheter system 10 may be configured to withdraw the guidewire 62 and the introducer needle 50 from the catheter system 10, as illustrated, for example, in fig. 1C. In more detail, in some embodiments, the guidewire 62 and introducer needle 50 may be withdrawn together in a proximal direction. In some embodiments, the guidewire 62 may be configured to remain protruding from 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 of the guidewire 62.

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

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

In some embodiments, the introducer needle 50 may include a sharp distal tip 72, a proximal end 60, and a lumen 76 extending through the sharp distal tip 72 and the proximal end 60. In some embodiments, the guidewire 62 may be disposed within the lumen 76 of the introducer needle 50 and/or may be configured to be advanced distally through the proximal end 60 of the introducer needle 50. In these embodiments, the proximal end 60 of the introducer needle 50 may be generally cylindrical and/or uncrimped, which facilitates movement of the guidewire 62 through the proximal end 60 of the introducer needle 50.

Referring now to fig. 5A-5 b, 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 with a detent 88 formed at an end of the extension 86. In some embodiments, first arm 82 and/or second arm 84 may further include a needle tip shielding tab 90, the needle tip shielding tab 90 being capable of stopping advancement of the sharp distal tip 72 after the V-clip needle shield 46 is engaged. In some embodiments, the needle tip shielding tab 90 may be used to prevent the sharp distal tip 72 from reappearance from the safety housing 44 after the introducer needle 50 is shielded by the safety housing 44.

In some embodiments, the pawl 88 may be made of metal that is bent approximately 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 flex in a range of about 30 degrees to about 180 degrees relative to the extension 86. In some embodiments, the pawl 88 may be curved in any direction that allows the pawl 88 to engage the catheter adapter 12. In some embodiments, the detents 88 on the V-clip needle shield 46 may be used to engage a crescent-shaped recess 92 on the catheter adapter 12 (see, e.g., fig. 5B). In some embodiments, the detents 88 may engage the grooves 92 to prevent the safety housing 44 from separating from the catheter adapter 12 until the introducer needle 50 is withdrawn far enough to activate the V-clip needle shield 46. Fig. 5B illustrates the pawl 88 separated from the groove 92 according to some embodiments.

In some embodiments, when the V-clip needle shield 46 is activated (fired), the first arm 82 will separate from the second arm 84 under the spring force of the knee 94. In some embodiments, the pawl 88 will move from the first position to the second position when the first arm 82 is disengaged from the second arm 84. 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 a position that engages the recess 92 to a position that does not engage the recess 92.

In some embodiments, to prevent the pawls 88 from prematurely disengaging from the grooves 92, the pawls 88 must have sufficient strength to avoid any bending, movement, displacement, or other action that may cause the V-clip needle shield 46 to separate from the catheter adapter 12 before the introducer needle 50 is advanced far enough to activate or engage the V-clip needle shield 46. In some embodiments, the V-clip needle shield may comprise any suitable V-clip needle shield, or may be further described in U.S. patent No.9,220,871, entitled "NEEDLE SHIELDING PAWL STRUCTURES" (needle shield pawl structure), filed 11/20/2007, the entire contents of which are incorporated herein by reference.

Referring again to fig. 1A-1C, in some embodiments, the safety housing 44 may include an open space 96 proximate to the V-clip needle shield 46 and proximal to the V-clip needle shield 46. In some embodiments, the open space 96 may be disposed in an axial direction or longitudinal axis direction 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 illustrated, for example, in fig. 1C. In some embodiments, as illustrated in fig. 1B-1C, the width of the open space 96 may be equal to or greater than the width of the V-clip needle shield 46, for example, which may allow the V-clip needle shield 46 to fire properly when the guidewire 62 extends distally beyond the sharp distal tip 72. In some embodiments, the sharp distal tip 72 may include a bevel 98 facing a top or upward direction 100 of the catheter system 10 (see, e.g., fig. 1B-1C), and the V-clip needle shield 46 may be configured to fire from side to side perpendicular to the upward direction 100. When ramp 98 faces in an upward direction 100, catheter system 10 is in an insertion position ready for insertion into a patient.

Referring now to fig. 5C, in some embodiments, the sharp distal tip 72 may include a bevel 98 facing in an upward direction (directly outward from the page), and the V-clip needle shield 46 may be configured to fire in an upward direction or in a downward direction opposite the upward direction. According to some embodiments, the cross-sectional view in fig. 5C is a top view and illustrates the bottom of the catheter system configured to be closest to the patient. Thus, in some embodiments, the open space 96 may be disposed perpendicular to the axial direction or perpendicular to the longitudinal axis direction of the catheter system 10. In some embodiments, the introducer needle 50 can include a needle boss 102 (see, e.g., fig. 2B), the needle boss 102 can prevent proximal movement of the introducer needle 50 from the safety housing 44.

Referring again to fig. 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 can include a needle boss 102, which needle boss 102 can snap onto a washer 104, which washer 104 has a smaller diameter bore than the needle boss 102. Thus, in some embodiments, when the guidewire advancement device 48 is moved proximally to proximally withdraw the introducer needle 50, the needle boss 102 will not pass through the aperture and the sharp distal tip 72 may be retained within the safety housing 44, preventing accidental needle sticks. 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 separated from the proximal end 16 when the sharp distal tip 72 is shielded within the safety housing 44.

In some embodiments, the guidewire 62 may be advanced distally via a particular guidewire advancement device, such as, for example, the guidewire advancement device 48 of fig. 1, the guidewire advancement device 106 of fig. 2, the guidewire advancement device 165 of fig. 8, or another suitable guidewire advancement device. In some embodiments, the use of an integral catheter system may facilitate separation of a particular guidewire advancing device from a fluid pathway or blood collection pathway through extension tube 20. In some embodiments, a particular guidewire advancing device may be removed from catheter system 10 after use. In some embodiments, removing a particular guidewire advancement device from the catheter system 10 may be configured to withdraw or remove the guidewire 62 and introducer needle from the catheter system 10 (or more specifically from the catheter assembly). In some embodiments, the guidewire 62 may remain protruding from the introducer needle 50 as the guidewire 62 and introducer needle 50 are withdrawn from the catheter system 10, which may prevent shearing.

In some embodiments, after a particular guidewire advancement device is removed from the catheter system 10, a catheter advancement device may be coupled to the proximal port 36 and a secondary catheter may be advanced into the catheter assembly via the catheter advancement device. In some embodiments, after removal of a particular guidewire advancement device from the catheter system 10, a stylet advancement device may be coupled to the proximal port, and a stylet of the stylet advancement 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.

Referring now to fig. 2A-2D, in some embodiments, the guidewire advancement device 106 may comprise a rotating element 107, the rotating element 107 configured to distally advance the guidewire 62 and/or proximally retract the guidewire 62. In some embodiments, the guidewire advancement device 106 may be similar or identical to the guidewire advancement device 48 of fig. 1A-1C in terms of one or more features and/or operations.

In some embodiments, the guidewire advancement device 106 can include a housing 108, the housing 108 having a distal end 110 and a proximal end 112. In some embodiments, the guidewire advancing device 106 may include a rotating element 107, the rotating element 107 enabling advancement of the guidewire 62 through the catheter assembly in a distal direction and/or subsequent withdrawal in a proximal direction. In some embodiments, the compartment 114 may be formed within the guidewire advancing device 106 and may house the rotating element 107. In some embodiments, a guidewire channel 116 may extend distally from the compartment 114 and through the distal end 110 of the housing 108.

As illustrated in fig. 2B-2C, in some embodiments, the rotating element 107 may include a pusher wheel 124, and the pusher wheel 124 may include a spool for the guidewire 62. Thus, in some embodiments, as the advancement wheel 124 rotates, the rotation may cause the guidewire 62 to advance or retract within the guidewire channel 116, depending on the direction in which the advancement wheel 124 rotates.

As illustrated in fig. 2D, in some embodiments, the rotating element 107 may include a spool 118 and a propulsion 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 pusher wheel 124 (i.e., toward the guidewire channel 116 relative to the pusher wheel 124). In some embodiments, the pusher wheel 124 may be positioned to partially protrude from the compartment 114, thereby enabling a user to rotate the pusher wheel 124 using his or her thumb or finger. In some embodiments, spool 118 may include a gear 119 having teeth. Also, in some embodiments, propulsion wheel 124 may include teeth, and thus may function as a gear. In some embodiments, the teeth of the propulsion wheel 124 may interface with the teeth of the gear 119 such that the spool 118 rotates when the propulsion wheel 124 rotates.

In some embodiments, spool 118 and propulsion wheel 124 may include shafts 120 and 121, respectively, that are positioned within compartment 114 by shafts 120 and 121 and rotate about shafts 120 and 121. In some embodiments, the spool 118 may include a spool drum 122, and the guidewire 62 may be wound around the spool drum 122. Thus, as the spool 118 rotates, depending on the direction in which the advancement wheel 124 rotates, the rotation may cause the guidewire 62 to be advanced or retracted within the guidewire channel 116. In some embodiments, the propulsion wheel 124 may include or correspond to any other propulsion wheel described in more detail in U.S. patent application No.17/709,935 entitled "INSTRUMENT DELIVERY DEVICES, SYSTEMS, AND METHODS" (INSTRUMENT delivery devices, systems, and METHODS) filed on 3-month 31 of 2022, which is incorporated herein by reference in its entirety.

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

Referring now to fig. 4A-4B, in some embodiments, the introducer needle 50 can include an aperture 128, the aperture 128 being disposed between the sharpened distal tip 72 and the proximal end 60 of the introducer needle 50. In some embodiments, the guidewire 62 may be configured to extend through the extension tube 20, the side port 18, and the aperture 128 and out the sharp distal tip 72 of the introducer needle 50. In these and other embodiments, the guidewire advancement device 48 of fig. 1A-1C or the guidewire advancement device 106 of fig. 2A-2D may be coupled to the proximal port 36 to advance and/or withdraw the guidewire 62 through the aperture 128 and the catheter 19.

Referring now to fig. 4C, in some embodiments, the proximal end 30 of the second extension tube 26 may be integral with the adapter 130, which may reduce the risk of fluid exposure to the user. In more detail, in some embodiments, the proximal end 30 of the second extension tube 26 may be permanently or non-removably coupled to the adapter 130, such as, for example, via an adhesive, a bond, a non-luer coupling, or another suitable permanent or non-removable 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 comprise a single port or a dual port.

In some embodiments, catheter system 10 may include a flash chamber 134, which flash chamber 134 may be disposed within a plug 136 coupled with 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 140 distal to the proximal end 138 of the flash chamber 134. In some embodiments, the vent 140 may be configured to pass air without passing blood. In some embodiments, a vent 140 may be provided toward the distal end of the flash chamber 134, which may hold some non-expelled air in the flash chamber 134 to provide arterial pulse visualization, thereby providing continuous visual confirmation of proper arterial access.

Referring now to fig. 6A-6C, the needle safety element may include a guide needle restraint mechanism 141, which guide needle restraint mechanism 141 may allow the guide needle 50 to move from an unshielded position (e.g., see fig. 6A) to a shielded position (e.g., see fig. 6B) in which the guide needle 50 is prevented from moving distally out of the restraint mechanism 141. In some embodiments, the introducer needle 50 may be captured bi-directionally and also prevented from moving distally out of the restraint mechanism 141. As used herein, the term "unshielded" may refer to the situation in which the sharp distal tip of the guide pin 50 is exposed from the inner housing of the restraint mechanism 141. Conversely, the term "shielding" may refer to the situation where the sharp distal tip 72 of the introducer needle 50 is covered, shielded, or otherwise protected by the inner housing of the constraining mechanism 141. In some embodiments, the restraint mechanism 141 may prevent unintended needle sticks and/or blood exposure because the restraint mechanism 141 allows the introducer needle 50 to be locked in the shielded position.

In some embodiments, the introducer needle restraint mechanism 141 can include an introducer needle 50 (e.g., introducer needle 50), a needle boss 102, an inner housing 142, and an outer housing 144. Additionally, in some embodiments, the restraint mechanism 141 may be selectively coupled with the catheter adapter 12. In some embodiments, when the introducer needle 50 is exposed from the inner housing 142 in the unshielded position, the introducer needle 50 may extend axially through the inner housing 142 and the outer housing 144 such that the sharpened distal tip 72 extends beyond the distal end 146 of the inner housing 142 and the distal end 147 of the outer housing 144. Additionally, in the unshielded position, the distal portion of the introducer needle 50 may extend into the catheter 19 and the outer housing 144 may be coupled to the catheter adapter 12.

In some embodiments, the inner housing 142 may be split longitudinally to form a plurality of arms 148. The inner housing 142 may include any number of arms, such as, for example, two, three, or four. In some embodiments, the arms 148 may extend distally from a proximal portion of the inner housing 142, such as a proximal end. In some embodiments, when the introducer needle 50 is exposed from the distal end 146 of the inner housing 142, the introducer needle 50 may be configured to bias the various arms 148 apart from one another. 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 respective arms 148 of the inner housing 142 may be resiliently splayed radially outward by the introducer needle 50, as illustrated, for example, in fig. 6A.

In some embodiments, the inner housing 142 may be made of any suitable material or materials, such as, for example, metal alloy, ceramic, plastic, polymer, and the like. Advantageously, the rigid plastic may allow the sharp distal tip 72 to embed into the inner surface of the inner housing 142 when in the shielding position. In some embodiments, the inner housing 142 may be a single piece. In some embodiments, the inner housing 142 may include multiple pieces that may be coupled together in a variety of ways, such as, for example, threaded connections, fittings, snaps, connections, attachments, fastenings, clamps, hooks, or any other suitable coupling means.

In some embodiments, the outer housing 144 may be configured to move from the compressed state illustrated in fig. 6A to the decompressed state illustrated in fig. 6B when the introducer needle 50 is proximally retracted within the inner housing 142 to the shielding position. In some embodiments, when the housing 144 is in the decompressed state, the outer housing 144 may bias the respective arms 148 of the inner housing 142 together, which may firmly seal or close the distal end 146 of the inner housing 142 and prevent the introducer needle 50 from exiting the distal end 146 of the inner housing 142.

In some embodiments, the outer housing 144 may slide or expand axially over at least a portion of the inner housing 142 when the outer housing 144 decompresses or moves from a compressed state (e.g., as illustrated in fig. 6A) to a decompressed state (e.g., as illustrated in fig. 6B). The portion of the inner housing 142 over which the outer housing 144 slides or expands may be of any suitable size or have any suitable shape. For example, portions of the inner housing 142 may be generally cylindrical, cubical, tubular, etc. The restoring force in the distal direction may cause the outer housing 144 to axially slide or expand as the outer housing 144 moves from the compressed state to the decompressed state.

In some embodiments, the outer housing 144 may include a compressible portion 150, and the compressible portion 150 may be disposed between the distal end 147 of the outer housing 144 and the proximal end 152 of the outer housing 144 and/or coupled with the distal end 147 of the outer housing 144 and the proximal end 152 of the outer housing 144. In some embodiments, the compressible portion 150 of the outer housing 144 may be compressed when the outer housing 144 is in the compressed state, and the compressible portion 150 of the outer housing 144 may be decompressed when the outer housing 144 is in the decompressed state. In some embodiments, compressible portion 150 may compress along an axis aligned with introducer needle 50. In some embodiments, compressible portion 150 may include a spring, an elastomer, or another compressible member. In some embodiments, the compressible portion 150 may be cylindrical. In some embodiments, the spring may be cylindrical and/or coiled. In some embodiments, the compressible portion 150 may be a baffle or accordion shape. In these and other embodiments, the 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 enclose the inner housing 142, and the inner housing 142 may serve as a redundant mechanism to ensure that any residual blood on the introducer needle 50 remains within the introducer needle restraint mechanism 141.

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

In some embodiments, the inner surface of catheter adapter 12 may be configured to secure inner housing 142 within catheter adapter 12 when introducer needle 50 is exposed from inner housing 142. In some embodiments, the inner surface of catheter adapter 12 may be configured to separate from inner housing 142 so as to release inner housing 142 from the catheter adapter when introducer needle 50 is proximally withdrawn within inner housing 142, as illustrated in fig. 6B. In more detail, in some embodiments, the outer surface of the inner housing may include one or more interlocking features 154, which interlocking features 154 may interact with one or more interlocking surfaces 156 formed in the inner surface of the catheter adapter 12. In some embodiments, the interlock feature 154 may be biased against a corresponding interlock surface 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 the introducer needle 50 within the inner housing 142, the radially inward contraction of the inner housing 142 may cause the one or more interlocking components 154 to disengage from the one or more interlocking surfaces 156, which may allow removal of the introducer needle restraint mechanism 141 from the catheter adapter 12, with the sharp distal tip 72 of the introducer needle 50 shielded within the inner housing 142. Accordingly, unintentional needle sticks can be prevented, and the guide needle restraint mechanism 141 can be safely provided.

In some embodiments, when the introducer needle 50 is proximally retracted within the inner housing 142 to the shielding position, the guidewire 62 may not be retracted and may remain protruding from the introducer needle 50, as illustrated, for example, in fig. 6B. In some embodiments, when the outer housing 144 is in the decompressed state, the outer housing 144 may bias the respective arms 148 of the inner housing 142 together, which may firmly 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 the decompressed state, the outer housing 144 may bias the respective arms 148 of the inner housing 142 together, and the arms 148 may clamp the guidewire 62, which may enhance the seal around the guidewire 62 and/or facilitate removal of the guidewire 62 with the introducer needle 50. In some embodiments, after the introducer needle is shielded in 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, more details of needle restraint mechanism 141 may be further described in U.S. patent No.10,507,281, entitled "CANNULA CAPTURE MECHANISM" (cannula restraint mechanism), filed on day 3, month 16 of 2017, which is incorporated herein by reference in its entirety.

Referring now to fig. 7, another type of spring clip, a cross arm clip 158, is illustrated in accordance with some embodiments. In some embodiments, the V-clip needle shield 46 of fig. 2B-2C or fig. 1B-1C may be replaced with a cross-arm clip 158 or another suitable spring clip or needle safety element. In these embodiments, the cross arm clamp 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, the catheter adapter 12 of fig. 1 or another suitable catheter adapter. In some embodiments, the cross-arm clip 158 may include a resilient first arm 160 and a resilient second arm 162 configured to cross each other. In some embodiments, the proximal ends of the first and second arms 160, 162 may be joined at a proximal wall that may include an opening sized and configured to slidably receive the proximal end of the introducer needle 50 when the introducer needle 50 is advanced in the distal direction. In some embodiments, a needle feature or bump (not shown) may prevent proximal withdrawal of the sharp distal tip 72 of the introducer needle 50 through the opening because the diameter of the needle feature or bump may be greater than the diameter of the opening.

In some embodiments, the distal ends of the first and second arms 160, 162 may be curved and/or may include a lip. In some embodiments, when the introducer needle 50 is in an insertion position ready for insertion into a patient, the introducer needle 50 may be disposed between the distal ends of the first and second arms 160, 162, biasing the first and second arms 160, 162 outwardly. In some embodiments, when the first and second arms 160, 162 are biased outwardly, they may engage an inner wall of the catheter adapter or an inner wall of the safety housing 44, thereby 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 proximal movement of the sharpened distal tip 72 toward the distal ends of the first and second arms 160, 162, the distal ends of the first and second arms 160, 162 may be closer to and/or overlap each other, which may release the cross arm clip 158 from the catheter adapter or safety housing 44 and prevent movement of the introducer needle 50 in the distal direction beyond the cross arm clip 158, as illustrated, for example, in fig. 7.

In some embodiments, the cross-arm clip 158 may not be modified for use with the guidewire 62, and/or may include the clip described further in U.S. patent No.7,972,313, entitled "SPRING CLIP SAFETY IV CATHETER" (spring-clip safety intravenous catheter), filed 11/22/2006, 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 aperture 164, the aperture 164 being sized and configured to receive the guidewire 62. In some embodiments, the diameter of the aperture may be smaller than the diameter of the introducer needle 50, which may prevent distal movement of the introducer needle 50 through the aperture in the shielded position. In some embodiments, the cross-arm clip 158 may be further described in U.S. patent No.11,291,803, entitled "CATHETER SYSTEM WITH GUIDEWIRE ADVANCEMENT ELEMENT" (catheter system with guidewire advancing element) filed on 1-month-3 of 2019, which is incorporated herein by reference in its entirety.

Referring now to fig. 8A-8B, in some embodiments, a guidewire advancement device 165 may include a rack 166 and a pinion 168. In some embodiments, the propulsion boss 66 may include a rack 166. In some embodiments, the push tab 66 may be similar or identical to the push tab 66 of fig. 1-2 in terms of one or more features and/or operations relative to the slot 64. In some embodiments, the guidewire advancement device 165 may be similar to or identical to the guidewire advancement device 48 and/or the guidewire advancement device 106 in terms of one or more features and/or operations. In some embodiments, the pinion 168 may include a spool for the guidewire 62. Thus, when the rack 166 is moved to rotate the pinion 168, the rotation may cause the guidewire 62 to be advanced or retracted, depending on the direction of movement of the rack 166 and rotation of the pinion 168.

Referring now to fig. 9A-9H, a catheter system 200 is illustrated, according to some embodiments. In some embodiments, the catheter system 200 may be similar or identical to fig. 1-8 in terms of one or more components and/or operations. In some embodiments, the catheter system 200 may include a catheter adapter 202, and the catheter adapter 202 may include a distal end 204, a proximal end 206, a lumen extending through the distal end 204 of the catheter adapter 202 and the proximal end 206 of the catheter adapter 202. In some embodiments, the catheter system 200 may include a catheter 209 extending from the distal end 204 of the catheter adapter 202.

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

In some embodiments, catheter system 200 may include an introducer needle 232, and introducer needle 232 may include a proximal end 234 and a sharp distal tip 236. In some embodiments, a removable covering 237 may be disposed over the sharp distal tip 236 to prevent accidental needle sticks. In some embodiments, the proximal end 234 of the introducer needle 232 can 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 as the guidewire 224 is advanced distally.

In some embodiments, the catheter system 200 may include a platform 238 disposed within the housing 222 and below the roller element 226. In some embodiments, the platform 238 may contact and support the guidewire 224. In some embodiments, the platform 238 may include a linear groove 240. In some embodiments, the guidewire 224 may be disposed within the linear groove 240, which may facilitate guiding of the guidewire 224 during distal advancement of the guidewire 224. In some embodiments, platform 238 may be substantially planar.

In some embodiments, the catheter system 200 may include opposing roller support grooves 242a, 242b disposed within the housing 222. In some embodiments, the roller element 226 may include opposing pins 244a, 244b mounted relative to the circular body of the roller element 226. In some embodiments, the opposing pins 244a, 244b may be configured to rotate within the opposing roller support grooves 242a, 242b. In other embodiments, the circular body may rotate on a shaft. In some embodiments, the circular body may extend through a slot 245 in the housing 222 and may be configured for easy rotation by a user's finger.

In some embodiments, the proximal end of the guidewire 224 may loop, coil, or otherwise be organized upon itself to facilitate distal movement and prevent entanglement. In some embodiments, the proximal end of the guidewire 224 may be disposed on the floor of the housing 222 below the platform 238. In some embodiments, in response to rotation of the roller element 226 in the proximal direction 228 or toward the proximal end 230 of the housing 222, the guidewire 224 may be configured to be advanced distally, including through the introducer needle 232 and the catheter 209 and into the vasculature of the patient.

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

In some embodiments, the catheter system 200 may include a septum 250 and a septum actuator 252 disposed in the lumen of the catheter adapter 202. In some embodiments, the septum activator 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 activator 252 moves distally through the septum 250, which septum 250 may include a slit 251. In some embodiments, in response to removing the external connector from the proximal end 206, the septum actuator 252 may be returned to a proximal position within the lumen and the septum 250 may be closed. Thus, in some embodiments, the septum 250 may help prevent blood from flowing through the catheter adapter 202 when the catheter adapter 202 is not engaged with an external connector. In some embodiments, unless the external connector is engaged with the catheter adapter 202 such that the septum actuator 252 moves distally and opens the septum 250, the fluid path through the catheter adapter 202 may be closed.

In some embodiments, the user can remove the removable needle covering 237 and secure the guidewire 224 within the introducer needle 232. In some embodiments, the tip adhesion may be disrupted prior to insertion of the introducer needle 232 and catheter 209 into the patient's skin. In some embodiments, after insertion of introducer needle 232 and catheter 209 through the skin into a blood vessel, the clinician may observe blood flashback in the flashback chamber of catheter system 200 or via a notch in introducer needle 232, allowing blood to flow between introducer needle 232 and catheter 209. In some embodiments, after the clinician observes that blood flashback confirms entry of the introducer needle 232 into the blood vessel, the roller element 226 can be rotated to move the guidewire 224 through the introducer needle 232.

In some embodiments, after guidewire 224 is advanced through introducer needle 232 and into the blood vessel, catheter adapter 202 may be advanced distally to further move catheter 209 into the blood vessel. In some embodiments, after further movement of the catheter 209 into the blood vessel, the housing 222 may be separated from the catheter adapter 202 and slowly moved proximally by the user, withdrawing the introducer needle 232 and guidewire 224 from the catheter adapter 202 and catheter system 200. In some embodiments, the housing 222, the guide needle 232, and the guidewire 224 may all be discarded into a suitable sharps container.

Referring now to fig. 10A-10C, a catheter system 260 is illustrated. In some embodiments, the catheter system 260 may be similar or identical to that of fig. 1-9 with respect to one or more components and/or operations. In some embodiments, the catheter system 260 may include a guidewire advancing device 262 coupled to the catheter adapter 202. In some embodiments, the guidewire advancement device 262 may include a housing 264, a slot 266 within the housing 264, a guidewire 224, and an advancement tab 268 extending through the slot 266 and configured to move linearly along the slot 266 to distally advance the guidewire 224. In some embodiments, the shape of the push tab 268 may facilitate smooth, supported movement through the lumen of the housing 264. In some embodiments, the guidewire 224 may be coupled to the advancement boss 268 and extend distally from the advancement boss 268. In some embodiments, slot 266 may include a snap feature 270, which snap feature 270 may engage with pushing tab 268 to prevent proximal movement of pushing tab 268 after pushing, thereby reducing the risk of shearing guidewire 224 over introducer needle 232.

All examples and conditional language recited herein are intended for pedagogical purposes to aid the reader in understanding the concepts contributed by the utility model and the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present utility model have been described in detail, it should be understood that various changes, substitutions, and alterations can be made hereto without departing from the spirit and scope of the utility model.

Claims

1. A catheter system, the catheter system comprising:

a catheter assembly, the catheter assembly comprising:

A catheter adapter comprising 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 between the distal end of the catheter adapter and the proximal end of the catheter adapter and in fluid communication with the lumen;

A catheter extending from a distal end of the catheter adapter;

An extension tube comprising a distal end and a proximal end, wherein the distal end of the extension tube is integral with the side port of the catheter adapter;

a needle assembly, the needle assembly comprising:

A needle safety element disposed within the safety housing;

A guidewire advancing device comprising a distal end, a proximal end, and a guidewire, and

An introducer needle comprising a proximal end and a sharp distal tip, wherein the proximal end of the introducer needle is coupled to the guidewire advancement device, wherein the introducer needle extends through the catheter, wherein the needle safety element is configured to shield the sharp distal tip.

2. The catheter system of claim 1, wherein removal of the guidewire advancement device from the catheter system is configured to withdraw the guidewire and the introducer needle from the catheter system, wherein the guidewire is configured to remain protruding from the introducer needle as the guidewire and the introducer needle are withdrawn from the catheter system.

3. The catheter system of claim 1, wherein the guidewire advancement device comprises a slot and an advancement tab linearly movable along the slot, wherein the advancement tab is for advancing the guidewire, 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 comprises a rack and pinion, wherein the advancement boss comprises the rack.

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

6. The catheter system of claim 1, wherein the introducer needle comprises a lumen extending through the sharp distal tip and the proximal end, wherein the guidewire is disposed within the lumen of the introducer needle and configured to move through the proximal end of the introducer needle for advancement.

7. The catheter system of claim 1, wherein the introducer needle comprises an outer groove, wherein the guidewire is disposed within the outer groove and configured to move through the outer groove to advance distally.

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

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

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

11. The catheter system of claim 1, wherein the extension tube is a first extension tube, the catheter system further comprising:

an access connector, wherein the access connector comprises a distal port, a proximal port, and a side port between the distal port and the proximal port, wherein the distal port and the proximal port are aligned with a longitudinal axis of the access connector, wherein the side port is angled with respect to the longitudinal axis of the access connector, wherein a proximal end of the first extension tube is integral with the distal port of the access connector, and

A second extension tube comprising a distal end and a proximal end, wherein the distal end of the second extension tube is integral with the side port of the access connector, wherein the first extension tube is shorter than the second extension tube, wherein the longitudinal axis of the access connector, the first extension tube, and the side port are configured to align to form a straight path.

12. The catheter system of claim 11, further comprising an adapter coupled to a proximal end of the second extension tube, a plug coupled to the adapter, a flash chamber disposed within the plug, and a vent distal to the proximal end of the flash chamber, wherein the proximal end of the second extension tube is integral with the adapter, wherein the proximal end of the flash chamber is closed, wherein the vent is configured to pass air without passing blood such that the plug is configured to retain undischarged air in the proximal end of the flash chamber in order to visualize an arterial pulse.

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

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

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

16. A catheter system, the catheter system comprising:

A catheter adapter comprising 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;

A catheter extending from a distal end of the catheter adapter;

A guidewire advancement device coupled to the catheter adapter, wherein the guidewire advancement device comprises a housing, a guidewire disposed at least partially within the housing, and a roller element extending through the housing and contacting the guidewire, wherein the guidewire is configured to advance distally in response to rotation of the roller element in a proximal direction, and

An introducer needle comprising a proximal end and a sharp distal tip, wherein the proximal end of the introducer needle is secured within the guidewire advancement device, wherein the introducer needle extends through the catheter.

17. The catheter system of claim 16, further comprising a platform disposed within the housing and below the roller element, wherein the platform comprises a linear groove, wherein the guidewire is disposed within the linear groove.

18. The catheter system of claim 16, further comprising opposing roller support grooves disposed within the housing, wherein the roller element comprises opposing pins configured to rotate within the opposing roller support grooves.

19. The catheter system of claim 16, wherein the distal end of the housing comprises a male luer fitting.

20. The catheter system of claim 16, further comprising a septum and a septum actuator disposed in a lumen of the catheter adapter.

21. A catheter system, the catheter system comprising:

A catheter extending from a distal end of the catheter adapter;

a guidewire advancement device coupled to the catheter adapter, wherein the guidewire advancement device comprises a housing, a slot within the housing, a guidewire, and an advancement tab extending through the slot and configured to move along the slot to distally advance the guidewire, and

An introducer needle comprising a proximal end and a sharp distal end, wherein the proximal end is secured within the guidewire advancement device, wherein the introducer needle extends through the catheter.