Device and method for distal loading of a guidewire - Patents.com

Abstract

Apparatus and methods are disclosed for distal loading of a guidewire (80) into a lumen of a catheter (90). Distal loading of a guidewire can be difficult due to the small diameter of the guidewire and the diameter of the lumen in which the guidewire is placed. Furthermore, misalignment of the guidewire can result in damage to the delicate and intricate distal tip structures. Embodiments can also include a barrier (160) and clip (170) system that facilitates a sterile, non-touch technique for subcutaneous placement of the catheter and guidewire assembly. A user can use the barrier, clip, and / or guidewire loading device to manipulate the catheter, advance the catheter, and remove the catheter once placed.

Description

[Technical field]

[0001] The present disclosure relates to devices and methods for distal loading of a guidewire. [Background technology]

[0002] Distal loading of a guidewire into the lumen of a catheter, dilator, or similar elongated medical device may be preferred, especially when proximal loading is hindered by the presence of an access port, hub, valve, or similar complex proximal structure. However, distal loading of a guidewire into the lumen of an elongated medical device may be difficult due to the small diameter of the guidewire and the small diameter of the lumen in which the guidewire is placed. Misalignment of the guidewire may result in damage to delicate and complex tip or lumen structures and / or damage to coatings on either the guidewire or the medical device, or both. Furthermore, handling the parts of these devices that enter the body during the guidewire loading process may increase the risk of infection. Even if proximal loading of a guidewire is possible, this may be undesirable since the guidewire must be advanced through the entire length of the elongated medical device. This leads to degradation of any coatings placed on either the guidewire or the medical device. Furthermore, misalignment may result in damage to either the guidewire or the medical device, or both. Summary of the Invention

[0003] Briefly summarized, embodiments disclosed herein are directed to apparatus and methods for distal loading of a guidewire into a lumen of a catheter, dilator, or similar elongate medical device. The embodiments facilitate alignment of the guidewire with the lumen of the elongate medical device and provide a protective barrier between the guidewire and any structure or coating disposed thereon. Additionally, the embodiments also include a flexible thin film barrier configured to mitigate direct contact with the catheter and / or provide a sterile environment for containing the catheter or a portion thereof that is placed subcutaneously. The membrane barrier mitigates the entry of pathogens and reduces the risk of infection. The embodiments further include a clip configured to facilitate gripping and advancement of the catheter into a patient using a sterile non-contact technique.

[0004] Disclosed herein is a catheter placement system including: a catheter defining a catheter lumen; and a guidewire loading device having a body defining a longitudinally extending device lumen, a funnel disposed at a distal end of the body and in communication with the device lumen, a slot extending longitudinally between the distal and proximal ends of the body and in communication with the device lumen, and a protrusion extending radially inward from an inner surface of the device lumen and configured to engage a skive disposed on an outer surface of the catheter.

[0005] In some embodiments, the device lumen includes a distally disposed funnel portion, a proximally disposed catheter portion, and an alignment portion disposed therebetween, and the protrusion extends from an inner surface of the catheter portion.

[0006] In some embodiments, the funnel defines a tapered inner contour extending from a first diameter at the distal end of the funnel to a second diameter at the proximal end of the funnel, the second diameter being smaller than the first diameter.

[0007] In some embodiments, the alignment portion defines a tapered inner contour extending from a second diameter at the distal end of the alignment portion to a third diameter at the proximal end of the alignment portion, the third diameter being equal to the inner diameter of the catheter lumen.

[0008] In some embodiments, the catheter portion defines a fourth diameter greater than the third diameter, and the walls of the catheter portion extend parallel to the longitudinal axis. In some embodiments, the fourth diameter is equal to or greater than the outer diameter of the catheter, and the catheter portion is configured to slidably engage the outer surface of the catheter.

[0009] In some embodiments, the fourth diameter is equal to or less than an outer diameter of the catheter, and the catheter portion is configured to engage the catheter with an interference fit. In some embodiments, the catheter section further comprises a tapered distal section, the inner contour of the tapered distal section mirroring the outer contour of the distal tip structure of the catheter.

[0010] In some embodiments, the device lumen further includes an abutment extending radially inward from a wall of the device lumen and configured to engage a distal tip of the catheter to prevent further distal movement of the catheter through the device lumen.

[0011] In some embodiments, the skive includes an opening in communication with the second catheter lumen. In some embodiments, the body includes a first body portion hingedly connected to a second body portion and pivotable through a plane extending perpendicular to the longitudinal axis.

[0012] In some embodiments, the first body portion and the second body portion are transitional between a closed position and an open position, and when the device is in the open position, the minimum diameter of the device lumen is greater than the outer diameter of the catheter.

[0013] In some embodiments, the protrusion is configured to disengage from the skive in the open position to allow the catheter to slide longitudinally relative to the body. In some embodiments, the guidewire loading device further includes a living hinge configured to bias the first and second body portions toward the closed position.

[0014] In some embodiments, the catheter deployment system further includes a guidewire defining an outer diameter less than or equal to the third diameter. In some embodiments, the catheter placement system further includes a barrier coupled to the guidewire loading device and extending proximally to surround a portion of the catheter.

[0015] In some embodiments, the barrier includes a longitudinally extending tear line. In some embodiments, the proximal end of the barrier is coupled to a clip configured to engage the catheter.

[0016] In some embodiments, the proximal clip includes a first clip body portion hingedly connected to a second body portion and defining a lumen, the diameter of the proximal clip lumen being greater than an outer diameter of the distal end of the barrier.

[0017] Also disclosed is a method of loading a guidewire into a lumen of a catheter, the method including: positioning a distal tip structure of the catheter within a lumen of a guidewire loading device; advancing a proximal end of the guidewire along a longitudinal axis into a funnel of the guidewire loading device, the funnel being disposed at a distal end of the lumen of the guidewire loading device; slidably engaging the guidewire with the lumen of the catheter; transitioning the guidewire loading device from a closed position to an open position; and disengaging the guidewire loading device from the catheter by sliding the catheter through a slot perpendicular to the longitudinal axis.

[0018] In some embodiments, the lumen of the guidewire loading device includes a distally disposed funnel portion, a proximally disposed catheter portion, and an alignment portion disposed therebetween.

[0019] In some embodiments, the method further includes engaging the catheter with the catheter portion of the lumen in one of an interference fit, a press fit, or a snap fit engagement. In some embodiments, the method further includes engaging the protrusion with a skive disposed on an outer surface of the catheter when the device is in a closed position, and disengaging the protrusion from the skive when the device is in an open position, the protrusion extending radially inward from an inner surface of the catheter portion.

[0020] In some embodiments, the funnel extends from a first diameter at the distal end to a second diameter at the proximal end. In some embodiments, the alignment portion extends from a second diameter at the distal end to a third diameter at the proximal end, the third diameter being equal to one or both of the lumen diameter of the catheter and the outer diameter of the guidewire.

[0021] In some embodiments, the method further includes pressing a distal tip of the catheter against an abutment disposed within the lumen of the guidewire loading device to prevent further distal movement of the catheter through the lumen of the guidewire loading device.

[0022] In some embodiments, the transitioning step further includes rotating the first arm relative to the second arm through a plane extending perpendicular to the longitudinal axis and rotating the first body portion away from the second body portion.

[0023] In some embodiments, the first body portion includes a first edge and the second body portion includes a second edge, the first edge and the second edge defining a slot. In some embodiments, the slot in the closed position defines a first width and the slot in the open position defines a second width, the first width being less than an outer diameter of the catheter and the second width being greater than an outer diameter of the catheter.

[0024] Further disclosed is a method of placing a catheter, the method including providing a catheter placement assembly including a guidewire loading device engaged to a distal end of the catheter, a barrier, and a clip; loading a guidewire into a lumen of the catheter by advancing the guidewire longitudinally proximally into a funnel of the guidewire loading device; transitioning the guidewire loading device from a closed position to an open position; and advancing a clip distally, the clip being releasably coupled to a portion of the catheter.

[0025] In some embodiments, the barrier is formed from a flexible material and surrounds the longitudinal axis of the guidewire loading device, with a distal end of the barrier being coupled to the guidewire loading device.

[0026] In some embodiments, the method further includes a connector ring coupled to the distal end of the barrier and releasably engaged with the proximal end of the guidewire loading device by one of an interference fit, a press fit, a snap fit engagement, a threaded engagement, a bayonet engagement, or a luer lock.

[0027] In some embodiments, the proximal end of the barrier is coupled to a clip and configured to maintain a sterile environment therein. In some embodiments, the transitioning step further comprises separating the cord from the barrier and breaking the barrier longitudinally along the tear line.

[0028] In some embodiments, the advancing step further comprises advancing a portion of the catheter through a lumen of the guidewire loading device. In some embodiments, the method further includes transitioning the guidewire loading device from an open position to a closed position to grip a first portion of the catheter, transitioning the clip from the closed position to the open position, sliding the clip proximally to grip a second portion of the catheter, and advancing the catheter in repeated steps.

[0029] In some embodiments, the advancing step further comprises disengaging the guidewire loading device from the catheter prior to distally advancing the clip. Further disclosed is a catheter placement system including a longitudinally extending catheter defining a catheter lumen, a guidewire loading device including a body defining a device lumen and an arm extending from the body and configured to transition the body between a closed position and an open position, and a barrier coupled to the guidewire loading device.

[0030] In some embodiments, the arm is configured to be rotatable relative to the body through a plane that extends parallel to the longitudinal axis. In some embodiments, the device lumen includes a funnel section, an alignment section, and a catheter section, where the diameter of the alignment section is equal to one or both of the outer diameter of the guidewire and the inner diameter of the catheter lumen, and the diameter of the catheter section is equal to the outer diameter of the catheter.

[0031] In some embodiments, the arms are configured to split the alignment portion of the body along the longitudinal axis to transition the diameter of the alignment portion to the outer diameter of the catheter when the device is in the open position.

[0032] A more particular description of the present disclosure will be made by reference to specific embodiments that are illustrated in the accompanying drawings. It is to be understood that these drawings depict only typical embodiments of the invention and are therefore not to be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0033] [Figure 1] 1 illustrates a guidewire loading system including a barrier, a guidewire, and a catheter, according to an embodiment disclosed herein. [Figure 2A] 1 illustrates a perspective proximal end view of a guidewire loading system according to an embodiment disclosed herein. [Figure 2B] 1 shows a perspective distal end view of a guidewire loading system according to an embodiment disclosed herein. [Figure 2C] 1 illustrates a cross-sectional view of a guidewire loading system in a closed position according to an embodiment disclosed herein. [Figure 2D] 1 illustrates a cross-sectional view of a guidewire loading system in an open position according to an embodiment disclosed herein. [Diagram 3] 1 shows a longitudinal cross-sectional view of a guidewire loading system according to an embodiment disclosed herein. [Figure 4A] 1 shows a perspective view of a barrier including a proximal clip for use with a guidewire loading system according to an embodiment disclosed herein. [Figure 4B] 1 illustrates a guidewire loading system including a barrier, a proximal clip, a guidewire, and a catheter, according to an embodiment disclosed herein. [Figure 5A] 1 illustrates a longitudinal cross-sectional view of a guidewire loading system in a closed position engaged with a catheter, according to an embodiment disclosed herein. [Figure 5B] 1 illustrates a longitudinal cross-sectional view of a guidewire loading system in an open position according to an embodiment disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0035] With regard to the terms used herein, it should also be understood that the terms are intended to describe some particular embodiments, and that the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Designations such as "left", "right", "up", "down", "front", "rear", etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one", "one", and "the" also include plural references unless the context clearly dictates otherwise.

[0036] In the following description, the terms "or" and "and / or" as used herein should be interpreted as inclusive or to mean any one or any combination. As an example, "A, B or C" or "A, B and / or C" means "any of the following: A, B, C, A and B, A and C, B and C, A, B and C." Exceptions to this definition occur only when combinations of elements, components, features, steps, or acts are in some way inherently mutually exclusive.

[0037] With respect to "proximal," for example, a "proximal portion" or "proximal end portion" of a catheter disclosed herein includes a portion of the catheter intended to be near a clinician when the catheter is used on a patient. Similarly, for example, a "proximal length" of a catheter includes a length of the catheter intended to be near a clinician when the catheter is used on a patient. For example, a "proximal end" of a catheter includes an end of the catheter intended to be near a clinician when the catheter is used on a patient. Although a proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, a proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless otherwise suggested by context, a proximal portion, proximal end portion, or proximal length of a catheter is not a terminal portion or terminal length of a catheter.

[0038] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, a "distal end" of a catheter includes an end of the catheter that is intended to be near or within a patient when the catheter is used with a patient. A distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, but a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a catheter.

[0039] To aid in illustrating the embodiments described herein, as shown in Figure 1, a longitudinal axis extends substantially parallel to the axial length of the catheter, a lateral axis extends perpendicular to the longitudinal axis, and a transverse axis extends perpendicular to both the longitudinal and lateral axes.

[0040] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. FIG. 1 illustrates a guidewire loading device ("device") 100 in an exemplary environment of use. The guidewire loading device 100 can be configured to provide a sterile, non-contact technique for distal loading of a guidewire 80 into a lumen 92 of a catheter 90. Distal loading of a guidewire into an elongated medical device can be difficult, especially when aligning the guidewire 80 with the lumen 92. Misalignment of the guidewire 80 can lead to damage to the distal tip structure 94 of the catheter 90. Optionally, the device 100 can also prevent needle-stick injuries from the distal tip of the elongated medical device. As used herein, catheter 90 is not intended to be limiting, and the catheter 90 can include a variety of catheters, dilators, cannulas, needles, or similar elongated medical devices configured to receive the guidewire 80 therein. In one embodiment, the device 100 can further include a barrier 160 coupled to the device 100 and extending over a portion of the catheter 90. In one embodiment, the barrier 160 can mitigate direct contact with the catheter 90 (or similar elongated medical device). In one embodiment, the barrier 160 can maintain a sterile environment in which at least a portion of the catheter 90 is disposed.

[0041] 2A-3 show further details of guidewire loading device 100. In one embodiment, device 100 includes a body 110 comprising a first body portion 110A hingedly coupled to a second body portion 110B by a hinge 114. Hinge 114 may be a mechanical hinge, a living hinge, or a similar mechanism configured to allow first body portion 110A to pivot relative to second body portion 110B through a plane extending at an angle to a longitudinal axis. In one embodiment, body 110 is formed from a plastic, polymer, thermoplastic, metal, alloy, composite, or similar substantially rigid or resilient material.

[0042] In one embodiment, the first body portion 110A and the second body portion 110B cooperate to define a lumen 112 extending from a proximal end of the device 100 to a distal end of the device 100 along the central longitudinal axis 70. The device 100 further includes a slot 116 extending longitudinally between the proximal and distal ends of the device 100 and in communication with the lumen 112. In one embodiment, the slot 116 is disposed on the opposite side of the central longitudinal axis 70 from the hinge 114. In one embodiment, the device 100 further includes a funnel 120 disposed at the distal end of the device 100. The funnel 120 defines a tapered inner profile, the apex of which is aligned with the central longitudinal axis 70 and in communication with the lumen 112.

[0043] In one embodiment, the body 110 includes one or more arms 130 extending therefrom and substantially perpendicular to the central longitudinal axis 70. FIG. 2C shows a cross-sectional view of the body 110 in a closed position, and FIG. 2D shows a cross-sectional view of the body 110 in an open position. The first body portion 110A includes a first arm 130A, and the second body portion 110B includes a second arm 130B. The arms 130 are configured to be grasped by a user and provide a mechanical advantage to transition the device 100 between the closed position (FIG. 2C) and the open position (FIG. 2D). In one embodiment, the first body portion 110A and the second body portion 110B pivot relative to each other about a hinge 114 to transition between the closed position (FIG. 2C) and the open position (FIG. 2D). In one embodiment, the device 100 may be biased toward the closed position.

[0044] In one embodiment, the first edge 122A of the first body portion 110A and the second edge 122B of the second body portion 110B define the slot 116. In one embodiment, with the device 100 in the closed position, the first edge 122A and the second edge 122B are in a spaced apart relationship such that the slot 116 defines a first width (w1) extending perpendicular to the longitudinal axis. In one embodiment, with the device 100 in the closed position, the first edge 122A contacts the second edge 122B to form a slit.

[0045] In one embodiment, with the device 100 in the open position, the first edge 122A and the second edge 122B are in a spaced apart relationship such that the slot 116 defines a second width (w2) extending perpendicular to the longitudinal axis. The second width (w2) is greater than the first width (w1). In one embodiment, the first width (w1) is equal to or less than the outer diameter of the catheter 90 to retain the catheter 90 within the device lumen 112. In one embodiment, the second width (w2) is equal to or greater than the outer diameter of the catheter 90 to allow the catheter 90 to enter / exit the device lumen 112. In one embodiment, the device 100 may further include one or more support structures 118 configured to provide increased stiffness to the device 100 during use.

[0046] 3 shows a longitudinal cross-sectional view of device 100. In one embodiment, lumen 112 includes a funnel portion 142, an alignment portion 144, and a catheter portion 146. In one embodiment, funnel portion 142 of lumen 112 defines a tapered inner contour that extends from a first diameter (d1) at a distal end of funnel portion 142 to a second diameter (d2) at a proximal end of funnel portion 142. The second diameter (d2) is smaller than the first diameter (d1). Funnel portion 142 defines a continuous or discontinuous change in diameter between the first diameter (d1) and the second diameter (d2).

[0047] In one embodiment, the alignment portion 144 of the lumen 112 defines a tapered inner contour that extends from a second diameter (d2) at the distal end of the alignment portion 144 to a third diameter (d3) at the proximal end of the alignment portion 144. The third diameter (d3) is smaller than the second diameter (d2). In one embodiment, the third diameter (d3) is equal to the inner diameter of the catheter lumen 92. The alignment portion 144 defines a continuous or discontinuous change in diameter between the second diameter (d2) and the third diameter (d3). In one embodiment, the walls of the funnel portion 142 define a steeper angle with respect to the longitudinal axis than the walls of the alignment portion 144. In one embodiment, the angle of the walls of the alignment portion 144 extends substantially parallel to the longitudinal axis.

[0048] In one embodiment, the catheter section 146 of the lumen 112 defines a fourth diameter (d4) greater than the third diameter (d3) and less than or equal to the first diameter (d1). In one embodiment, the walls of the catheter section 146 extend substantially parallel to the longitudinal axis. In one embodiment, the distal portion of the catheter section 146 defines a tapered inner contour configured to mirror the outer contour of the distal tip structure 94 of the catheter 90. The tapered inner contour of the catheter section 146 extends distally from the fourth diameter (d4) to the third diameter (d3).

[0049] In one embodiment, the fourth diameter (d4) is equal to or slightly larger than the outer diameter of the catheter 90. In one embodiment, the fourth diameter (d4) is equal to or slightly smaller than the outer diameter of the catheter 90 to engage the catheter 90 in a friction fit engagement. In one embodiment, the inner surface of the catheter section 146 includes one or more protrusions 150 extending radially inward. The protrusions 150 are configured to engage skives or openings disposed in the sidewall of the catheter 90 to secure a portion of the catheter 90 within the catheter section 146 in a snap fit engagement. In one embodiment, the skives are recesses or detents disposed on the outer surface of the catheter 90. In one embodiment, the skives are openings that communicate with a lumen 92 of the catheter, e.g., the first catheter lumen 92A or the second catheter lumen 92B. Thus, protrusions 150 mitigate dislodgment of device 100 from catheter 90 when guidewire 80 is urged proximally into catheter lumen 92. In one embodiment, the proximal end of device lumen 112 includes a chamfered or beveled edge configured to facilitate aligning a distal portion of catheter 90 with the proximal end of device lumen 112.

[0050] In one embodiment, the distal portion of the catheter 90 is received within the catheter section 146 of the lumen 112. The device 100 engages the catheter 90 in an interference, press-fit, or friction-fit engagement to retain the catheter 90 within the catheter section 146 of the lumen 112. In one embodiment, the protrusions 150 engage skives or openings disposed within the catheter 90 to retain the catheter 90 within the catheter section 146 in a snap-fit ​​engagement. In one embodiment, the distal end of the catheter section 146 includes an abutment portion 148 configured to engage the distal end of the catheter 90. The catheter 90 is advanced distally within the catheter section 146 until the distal tip of the catheter 90 abuts the abutment portion 148 and prevents further advancement thereof. Additionally, the catheter section 146 is configured to align the distal opening of the catheter lumen 92 with the proximal end of the alignment portion 144. As mentioned above, the third diameter (d3) is equal to the diameter of the catheter lumen 92 at the distal opening.

[0051] In one embodiment, the guidewire 80 is inserted into the distal end of the lumen 112. The outer diameter of the guidewire 112 is equal to or less than the inner diameter of the catheter lumen 92, i.e., equal to or less than the third diameter (d3). As the guidewire 80 is advanced proximally into the device 100, the funnel portion 142 aligns the proximal end of the guidewire 80 with the alignment portion 144. The alignment portion 144 further aligns the proximal end of the guidewire 112 with the catheter lumen 92. Thus, the device 100 facilitates loading the guidewire 80 into the distal end of the catheter 90 while protecting the distal tip structure 94 of the catheter 90.

[0052] 2A-2D , with guidewire 70 loaded within catheter lumen 92, a user can actuate arms 130 to transition device 100 from a closed position to an open position and remove device 100 from the assembly of catheter 90 and guidewire 70. A user can apply opposing "clamping" forces to first arm 130A and second arm 130B, pivoting arms 130A, 130B toward one another and rotating body portions 110A, 110B about hinge 144 to transition device 100 to the open position.

[0053] In one embodiment, the first edge 122A of the first body portion 110A and the second edge 122B of the second body portion 110B, which define the slot 116, rotate away from one another through a plane extending perpendicular to the longitudinal axis. In the open position, the width of the slot 116 increases from a first width (w1) to a second width (w2). In one embodiment, the second width (w2) is greater than the outer diameter of the catheter, i.e., equal to or greater than the diameter (d4), allowing the catheter 90 and guidewire 70 assembly to pass laterally through the slot 116 and remove the device 100.

[0054] In one embodiment, the hinge 114 is malleable and configured to remain in the open position until repositioned by a user. In one embodiment, the device 100 is biased to a closed position. Thus, when a user releases the arm 130, the device 100 returns to the closed position. In one embodiment, the hinge 114 is a living hinge formed from a resilient material and can bias the device 100 toward the closed position. In one embodiment, one or both of the first edge 122A and the second edge 122B include a magnetic material (e.g., a permanent magnet, a steel material, a magnetizable material, etc.) configured to bias the device 100 toward the closed position.

[0055] In one embodiment, as shown in Figures 1 and 4A-4B, the device 100 further includes a barrier 160 formed from a flexible thin film material and extending around the central longitudinal axis 70 of one or both of a portion of the device 100 and at least a portion of the catheter 90. Thus, the barrier 160 reduces direct contact with the catheter 90 or the portion of the catheter 90 designed to be placed inside the patient's body. In one embodiment, the barrier 160 is formed from a flexible membrane, a gas impermeable material, and / or a polymeric material and is configured to maintain a sterile environment therein. In one embodiment, the barrier 160 is formed as an extruded substantially cylindrical shape and is coupled to the device 100 to surround the central lumen 112 of the device 100 and / or the catheter 90.

[0056] In one embodiment, the distal end of the barrier 160 is coupled to the distal end of the body 110, enclosing both the device 100 and a portion of the catheter 90 therein. In one embodiment, the distal end of the barrier 160 is coupled to a proximal end or midpoint of the body 110 of the device 100. In one embodiment, the proximal end of the barrier 160 defines an opening, allowing a portion of the catheter 90 to extend therethrough. In one embodiment, the proximal end of the barrier 160 is coupled to a portion of the catheter 90, e.g., the hub 96 or the extension leg 98. Thus, the barrier 160 encloses a portion of the catheter 90, e.g., the portion that is disposed within the patient's body, within a sterile environment, mitigating the ingress of pathogens. In one embodiment, the proximal end of the barrier 160 extends proximal to the proximal end of the catheter 90, enclosing the entire catheter 90 within the sterile environment defined by the barrier 160.

[0057] In one embodiment, the barrier 160 includes a longitudinally extending tear line 162. The tear line 162 may include a groove, score line, perforation, laser cut line, or similar line of weakness configured to allow the barrier 160 to separate along the tear line 162 as the device 100 transitions to the open position. In one embodiment, the tear line 162 includes a cord extending along the tear line 162. Separating the cord from the barrier 160 causes the barrier 160 to break along the cord, facilitating separation of the barrier 160. In one embodiment, the barrier 160 is formed as a sheet material having a first longitudinal edge bonded to a second longitudinal edge opposite the first longitudinal edge to form the tear line 162. The first longitudinal edge may be bonded to the second longitudinal edge to form the tear line 162 using adhesives, bonding, welding, or the like. This may simplify the manufacturing process of the barrier 160.

[0058] In one embodiment, transitioning device 100 to the open position causes a first portion of barrier 160 coupled to first body portion 110A and a second portion of barrier 160 coupled to second body portion 110B to separate along tear line 162, allowing the catheter 90 and guidewire 70 assembly to pass therebetween. Device 100, including barrier 160, can then be removed from catheter 90.

[0059] In one embodiment, as shown in FIGS. 4A-4B, the barrier 160 includes a clip 170 coupled to a proximal end of the barrier 160 and configured to engage a portion of the catheter 90 similar to the guidewire loading device 100. The clip 170 includes a body 174 defining a clip lumen 172 and includes one or more arms 178. The body 174 further includes a longitudinally extending hinge 178 configured to allow the body 174 to transition between an open position and a closed position when opposing "clamping" forces are applied to the arms 178 as described herein (see, e.g., FIGS. 2C-2D). In the open position, a slot 168 disposed across the clip lumen 172 on the opposite side of the hinge 178 can be opened to allow the catheter 90 to enter / exit the clip lumen 172. The catheter 90 may enter and exit along an axis extending perpendicular to the longitudinal axis.

[0060] In one embodiment, clip 170 engages a proximal portion of catheter 90, for example adjacent hub 96. A portion of catheter 90 extends through clip lumen 172. In one embodiment, clip 170 releasably engages hub 96 with one of an interference fit, press fit, snap fit engagement, or similar suitable engagement mechanism. In one embodiment, a proximal end of barrier 160 is coupled with a distal end of clip lumen 172. In one embodiment, a distal end of barrier 160 is coupled to device 100 as described herein. In one embodiment, a distal end of barrier 160 includes a connector ring 180 configured to releasably engage device 100 with one of an interference fit, press fit, or snap fit engagement. In one embodiment, connector ring 180 releasably engages device 100 with a threaded engagement, a bayonet engagement, a luer lock, or similar suitable connection mechanism. In one embodiment, connector ring 180 is splittable such that connector ring 180 can be laterally separated from the portion of catheter 90 that extends through connector ring 180 when device 100 is transitioned to the open position.

[0061] In one embodiment, the distal end of the barrier 160 defines a first outer diameter (d5) and the proximal end of the barrier 160 defines a second outer diameter (d6) that is larger than the first outer diameter (d5). In one embodiment, the catheter 90 is advanced distally through a connector ring 180 at the distal end of the barrier 160 by grasping the proximal clip 170 and urging the clip 170 longitudinally distally. Note that the clip 170 is coupled to the catheter 90, for example at the hub 96, or grasps the outer surface of the shaft of the catheter 90 in an interference fit engagement. Thus, the flexible barrier 160 folds upon itself to allow the catheter 90 to be advanced distally. Because the first outer diameter (d5) is smaller than the second outer diameter (d6), the barrier 160 folds into a clip lumen 172 that contains the barrier 160 in a folded state within the body 174 of the clip 170. Catheter 90 is then advanced distally using a sterile, non-touch technique.

[0062] In one embodiment, once the guidewire 80 is loaded, the user can advance the catheter 90 using a sterile, non-touch technique. For example, the user actuates the arm 130 to transition the device 100 from a closed position to an open position. In the open position, the first body portion 110A and the second body portion 110B rotate outwardly such that the device lumen 112 at the distal end of the catheter section 146 separates to a width greater than the outer diameter of the catheter 90. Thus, the catheter 90 can slide longitudinally through the lumen 112 such that the distal tip structure 94 extends distally of the abutment portion 148. The user can then grasp the proximal clip 170 and manipulate the catheter 90 to advance the catheter 90 distally through the device lumen 112. As the catheter 90 is urged distally, the barrier 160 folds and is contained within the clip lumen 172.

[0063] In one embodiment, a user can manipulate the device 100 and clip 170 to advance the catheter 90 in a stepwise manner using a sterile, non-contact technique. For example, in one embodiment, the clip 170 grips the catheter 90 at a midpoint, i.e., a location between the distal tip structure 94 and the hub 96. The user then actuates the arms 130 of the device 100 to open the lumen 112 as described herein. The user then grips the clip 170 and advances a portion of the catheter 90 through the device lumen 112. The user then releases the arms 130 and the device 100, which is biased toward the closed position, grips the catheter 90 within the device lumen 112. The user then actuates the clip's arms 176 to release the catheter 90 and slide the clip proximally. The user then releases the clip's arms 176 to transition the clip 170 from the open position to the closed position. Optionally, the clip 170 is also biased toward the closed position. The user then grasps a second portion of the catheter 90 and repeats the process of advancing the catheter 90 through the device lumen 112 in a repeat step.

[0064] In one embodiment, device 100 including one of barrier 160 and connecting ring 180 disengages catheter 90 by urging catheter 90 through slot 116 while device 100 is in a closed position. In one embodiment, connecting ring 180 includes slot 186 that aligns with slot 116 of device 100 when coupled to device 100. In one embodiment, device 100 including one of barrier 160 and connecting ring 180 disengages catheter 90 by transitioning device 100 to an open position, optionally splitting one or both of connecting ring 180 (i.e., at slot 186) and barrier 160 along tear line 162. Catheter 90 is then slid laterally through slot 116.

[0065] In one embodiment, the user disengages device 100 from catheter 90 before advancing catheter 90 distally into the patient. Thus, with the distal ends of device 100 and barrier 160 clear of catheter 90, the user then grasps clip 170 and advances catheter 90 distally into the patient. Barrier 160 separates along tear line 162 as catheter 90 advances. Once catheter 90 is positioned within the patient, the user actuates proximal clip arm 176 to pivot clip body 174 to an open position. Catheter 90 is then disengaged from clip 170 by passing catheter 90 laterally through clip slot 168.

[0066] 5A-5B illustrate one embodiment of a guidewire loading device ("device") 200 configured to engage a distal portion of a catheter 90 and facilitate distal loading of a guidewire 80, as described herein. In one embodiment, device 200 includes a body 210 defining a lumen 212 having one or more of a funnel portion 242, an alignment portion 244, and a catheter portion 246. In one embodiment, device 200 includes one or more arms 230 coupled to device 200. Arms 230 are configured to pivot relative to body 210 through a plane extending parallel to central longitudinal axis 70 to transition device 200 between a closed position (FIG. 5A) and an open position (FIG. 5B).

[0067] In one embodiment, the catheter portion 246 of the lumen 212 engages the distal portion of the catheter 90 in one of an interference fit, press fit, or snap fit engagement, as described herein. In one embodiment, the device 200 further includes one or more protrusions 250 configured to engage skives or openings disposed in the catheter 90 and retain the distal tip structure 94 of the catheter 90 within the catheter portion 246, as described herein. With the catheter tip structure 94 secured within the catheter portion 246, the guidewire 80 can be advanced through the funnel portion 242 and the alignment portion 244 to align the guidewire 80 with the catheter lumen 92 and advance the guidewire 80 proximally into the catheter lumen 92.

[0068] In one embodiment, the device 200 transitions from a closed position (FIG. 5A) to an open position (FIG. 5B) by rotating the arms 230 outwardly through a plane extending parallel to the central longitudinal axis 70. In one embodiment, in the open position, the protrusions 250 disengage from the skive, releasing the catheter 90. In one embodiment, transitioning the arms 230 to the open position splits a portion of the body 210 along the longitudinal axis, allowing the assembly of the catheter 90 and guidewire 80 to be removed from the device 200. In one embodiment, in the open position, the arms 230 split the alignment portion 244 along the longitudinal axis into the first and second body portions 210A and 210B. Each of the first and second body portions 210A and 210B pivots about a hinge 214 that couples the distal ends of the first and second body portions 210A and 210B, respectively, to the funnel 220. Thus, the proximal end of the alignment portion 244 can expand radially outward from the third diameter (d3) to a diameter equal to or greater than the outer diameter of the catheter 90, i.e., diameter (d4), enabling distal advancement of the catheter 90 through the device lumen 212.

[0069] In one embodiment, with the device 200 in the open position, the user grasps the proximal end of the body 210 adjacent the catheter portion 246 and elastically deforms a portion of the body 210 to grasp the catheter 90 disposed therein. The user then manipulates the catheter 90 in a sterile, non-contact technique by grasping the catheter within the lumen 212. The user then releases the body 210, then releases the catheter 90 and slides the body 210 proximally over the catheter 90. The user then repeats the process to grasp a second portion of the catheter 90 and continues to advance the catheter 90. Thus, the user advances the catheter 90 in an iterative process without touching the catheter 90. In one embodiment, the device 200 further includes one or more of the barrier 160, clip 170, and connector 180 to prevent direct contact with the catheter 90 or provide a sterile environment while facilitating a sterile, non-contact catheter placement technique as described herein.

[0070] Although some specific embodiments have been disclosed herein, and those specific embodiments have been disclosed in some detail, those specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may become apparent to those skilled in the art, and are likewise encompassed in the broader aspects. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. 1. A catheter placement system comprising: a catheter defining a catheter lumen; 1. A guidewire loading device comprising: a body defining a longitudinally extending device lumen; a funnel disposed at a distal end of the body and in communication with the device lumen; a slot extending longitudinally between the distal and proximal ends of the body and communicating with the device lumen; a protrusion extending radially inward from an inner surface of the device lumen and configured to engage a skive disposed on an outer surface of the catheter.

2. 10. The catheter placement system of claim 1, wherein the device lumen includes a distally disposed funnel portion, a proximally disposed catheter portion, and an alignment portion disposed between the funnel portion and the catheter portion, and the protrusion extends from an inner surface of the catheter portion.

3. 3. The catheter deployment system of claim 2, wherein the funnel defines a tapered inner contour extending from a first diameter at a distal end of the funnel to a second diameter at a proximal end of the funnel, the second diameter being smaller than the first diameter.

4. 4. The catheter deployment system of claim 3, wherein the alignment portion defines a tapered inner contour extending from the second diameter at the distal end of the alignment portion to a third diameter at the proximal end of the alignment portion, the third diameter being equal to an inner diameter of the catheter lumen.

5. 5. The catheter placement system of claim 4, wherein the catheter portion defines a fourth diameter greater than the third diameter, and wherein a wall of the catheter portion extends parallel to a longitudinal axis.

6. 6. The catheter deployment system of claim 5, wherein the fourth diameter is equal to or greater than an outer diameter of the catheter, and the catheter portion is configured to slidably engage an outer surface of the catheter.

7. The catheter deployment system of claim 5 , wherein the fourth diameter is equal to or less than an outer diameter of the catheter, and the catheter portion is configured to engage the catheter with an interference fit.

8. 8. The catheter deployment system of claim 2, wherein the catheter portion further comprises a tapered distal section, the inner contour of the tapered distal section mirroring the outer contour of the distal tip structure of the catheter.

9. 8. The catheter placement system of claim 1, wherein the device lumen further comprises an abutment extending radially inward from a wall of the device lumen and configured to engage a distal tip of the catheter to prevent further distal movement of the catheter through the device lumen.

10. The catheter deployment system of any one of claims 1 to 7, wherein the skive includes an opening in communication with a second catheter lumen.

11. 8. The catheter deployment system of claim 1, wherein the body includes a first body portion hingedly connected to a second body portion and pivotable through a plane extending perpendicular to the longitudinal axis.

12. 12. The catheter placement system of claim 11, wherein the first body portion and the second body portion are transitionable between a closed position and an open position, and when the guidewire loading device is in the open position, a minimum diameter of the device lumen is greater than an outer diameter of the catheter.

13. The catheter deployment system of claim 12 , wherein the protrusion is configured to disengage from the skive in the open position to allow the catheter to slide longitudinally relative to the body.

14. The catheter deployment system of claim 11 , wherein the guidewire loading device further comprises a living hinge configured to bias the first and second body portions toward a closed position.

15. The catheter deployment system of any one of claims 4 to 7, further comprising a guidewire defining an outer diameter less than or equal to the third diameter.

16. The catheter deployment system of any one of claims 1 to 7, further comprising a barrier coupled to the guidewire loading device and extending proximally to surround a portion of the catheter.

17. The catheter deployment system of claim 16 , wherein the barrier includes a longitudinally extending tear line.

18. The catheter deployment system of claim 16 , wherein the proximal end of the barrier is coupled to a clip configured to engage the catheter.

19. 20. The catheter deployment system of claim 18, wherein the clip includes a first clip body portion hingedly connected to a second body portion and defining a clip lumen, the diameter of the clip lumen being greater than an outer diameter of the distal end of the barrier.

20. 1. A catheter placement system comprising: a longitudinally extending catheter defining a catheter lumen; a guidewire loading device including: a body defining a device lumen; and an arm extending from the body and configured to transition the body between a closed position and an open position; a barrier coupled to the guidewire loading device.

21. 21. The catheter deployment system of claim 20, wherein the arm is configured to be rotatable relative to the body through a plane extending parallel to a longitudinal axis.

22. 22. The catheter placement system of claim 20 or 21, wherein the device lumen includes a funnel portion, an alignment portion, and a catheter portion, the diameter of the alignment portion being equal to one or both of an outer diameter of a guidewire and an inner diameter of the catheter lumen, and the diameter of the catheter portion being equal to an outer diameter of the catheter.

23. 23. The catheter placement system of claim 22, wherein the arms are configured to split the alignment portion of the body along a longitudinal axis to transition the diameter of the alignment portion to an outer diameter of the catheter when the guidewire loading device is in the open position.

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