Guidewire system with lubricious coating

Abstract

A catheter and guidewire system 100 includes a catheter 110 defining a catheter lumen and including an antimicrobial coating disposed on an inner surface of the catheter lumen, and a guidewire 120 with a body extending along a longitudinal axis between a proximal end and a distal tip. The guidewire is disposed within the lumen of the catheter and features a lubricious coating 140 on its outer surface, which comprises one or more materials selected from liquid silicone oil, curable silicone lube, and parylene. This coating is designed to enhance the guidewire's maneuverability and reduce friction during insertion and navigation within a patient's body, thereby improving the overall performance and safety of medical procedures involving the guidewire.

Description

GUIDEWIRE SYSTEM WITH LUBRICIOUS COATINGPRIORITY

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 554,756, filed February 16, 2024, which is incorporated in its entirety into this application.BACKGROUND

[0002] In the field of medical devices, particularly catheter and guidewire systems, various approaches have been developed to enhance the maneuverability and performance of guidewires. Traditional guidewires have often been constructed from stainless steel or nitinol, providing the necessary flexibility and strength to navigate through the vascular system. However, these materials alone can create friction against the inner walls of catheters, potentially leading to difficulties in sliding the guidewire smoothly, dislodgement of the catheter placement, and increasing the risk of vessel trauma.

[0003] These difficulties can be exacerbated by the construction of the catheter / guidewire systems and / or the addition of various coatings, such as antimicrobial coatings or the like. For example, certain polymers used to form the catheter can provide increased friction coefficients. Further, guidewires can be formed as a solid wire, a coiled wire, or coiled wire over solid core. Each of these configurations can provide different modus of elasticity, different surface textures, and the like, and all of which can affect the friction coefficients between the guidewire and the catheter. In addition, certain coatings disposed on one or both of the guidewire and catheter can also increase the friction coefficient therebetween. For example, certain antimicrobial coatings disposed on the inner surface of the catheter lumen can provide increased tackiness that, in turn, increases the friction coefficient between the catheter and guidewire.

[0004] What is needed therefore is a system and method to reduce drag forces without affecting the performance of the catheter and guidewire system. Embodiments disclosed herein are directed to address the foregoing.SUMMARY

[0005] Embodiments disclosed herein are directed to systems and methods of catheter placement including a guidewire having a lubricious coating. The guidewire is disposed within a catheter lumen for placement of the catheter intravascularly. The lubricious coating reduced the drag force between the guidewire and the catheter. When the guidewire is withdrawn proximally from the catheter after placement, the lubricious coating reduces drag and mitigates displacement of the catheter tip. The guidewire lubricious coating can be one or more of a liquid silicone oil, a cured silicone lube, and / or a parylene coating.

[0006] In some aspects, the techniques described herein relate to a catheter and guidewire system including, a guidewire having a body extending along a longitudinal axis between a proximal end and a distal tip, and a lubricious coating disposed on an outer surface of the guidewire body and including one or more of a liquid silicone oil, a curable silicone lube, and a parylene.

[0007] In some aspects, the techniques described herein relate to a catheter and guidewire system, wherein the liquid silicone oil has a viscosity of 1 million centistokes (cSt) and is configured to mitigate migration of the lubricious coating during transport or storage.

[0008] In some aspects, the techniques described herein relate to a catheter and guidewire system, wherein the guidewire body includes a monolithic wire extending longitudinally and defining a smooth outer surface.

[0009] In some aspects, the techniques described herein relate to a catheter and guidewire system, wherein the guidewire body includes a coil having a wire extending helically about a central longitudinal axis of the guidewire body.

[0010] In some aspects, the techniques described herein relate to a catheter and guidewire system, wherein the guidewire body includes a core wire extending along a central longitudinal axis and a coil having a wire extending helically about the core wire.

[0011] In some aspects, the techniques described herein relate to a catheter and guidewire system, wherein the coil includes a first turn extending through 360° and a second turn disposed adjacent the first turn in a longitudinally spaced apart relationship from the first turn.

[0012] In some aspects, the techniques described herein relate to a catheter and guidewire system, wherein the coil includes a first turn extending through 360° and a second turn disposed longitudinally adjacent to the first turn, and in contact with the first turn.

[0013] In some aspects, the techniques described herein relate to a catheter and guidewire system, wherein the lubricious coating is a conformal layer disposed over the surface of the guidewire body at a thickness of between 1 pm-250pm.

[0014] In some aspects, the techniques described herein relate to a catheter and guidewire system, wherein the lubricious coating is a non-conformal layer disposed over the surface of the guidewire body at a minimum thickness of between lpm-250pm.

[0015] In some aspects, the techniques described herein relate to a catheter and guidewire system, further including a catheter defining a lumen and including a second coating, different from the lubricious coating, and disposed thereon.

[0016] In some aspects, the techniques described herein relate to a catheter and guidewire system, wherein the second coating is an anti-microbial coating and wherein the lubricious coating mitigates migration of the second coating during transport or storage.

[0017] In some aspects, the techniques described herein relate to a catheter and guidewire system wherein the guidewire is configured to extend through the lumen of the catheter, an outer diameter of the guidewire being less than an inner diameter of the catheter lumen.

[0018] In some aspects, the techniques described herein relate to a method of placing a catheter including, providing a catheter having a body extending along a longitudinal axis and defining a lumen, placing a guidewire within the catheter lumen, the guidewire including, a guidewire body extending between a proximal end and a distal tip, and a lubricious coating disposed on an outer surface of the guidewire body and including one or more of a liquid silicone oil, a curable silicone lube, and a parylene, advancing the catheter and guidewire assembly to a target location within a body of a patient, and applying a force to the guidewire to withdraw the guidewire from the catheter lumen.

[0019] In some aspects, the techniques described herein relate to a method, wherein applying a force includes applying a force less than 0.5 Ibf.

[0020] In some aspects, the techniques described herein relate to a method, wherein the liquid silicone oil has a viscosity of 1 million centistokes (cSt) and is configured to mitigate migration of the lubricious coating during transport or storage.

[0021] In some aspects, the techniques described herein relate to a method, wherein the guidewire body includes a monolithic wire extending longitudinally and defining a smooth outer surface.

[0022] In some aspects, the techniques described herein relate to a method, wherein the guidewire body includes a coil having a wire extending helically about a central longitudinal axis of the guidewire body.

[0023] In some aspects, the techniques described herein relate to a method, wherein the guidewire body includes a core wire extending along a central longitudinal axis and a coil having a wire extending helically about the core wire.

[0024] In some aspects, the techniques described herein relate to a method, further including applying the lubricious coating to the guidewire body prior to placing the guidewire within the catheter lumen, by dipping the guidewire body into a solution including the lubricious coating dissolved in a solvent to form a conformal layer disposed over the surface of the guidewire body at a thickness of between 1 pm-250pm.

[0025] In some aspects, the techniques described herein relate to a method, wherein the solvent includes one or more of an alkane solvent, a paraffin, a saturated hydrocarbon, or heptane.

[0026] In some aspects, the techniques described herein relate to a method further including applying a second coating to the catheter lumen including an anti-microbial coating and wherein the lubricious coating mitigates migration of the second coating during transport or storage.

[0027] In some aspects, the techniques described herein relate to a method of making a catheter and guidewire system including, forming a guidewire including, forming a guidewire body extending along a longitudinal axis, and forming a lubricious coating on the outer surface of the guidewire by dipping the guidewire in a solution including a liquid silicone oil dissolved in a heptane solvent.

[0028] In some aspects, the techniques described herein relate to a method, wherein the lubricious coating including the liquid silicone oil has a viscosity of 1 million centistokes (cSt) and is configured to mitigate migration during transport and storage.

[0029] In some aspects, the techniques described herein relate to a method, further including placing guidewire in a lumen of a catheter body, and wherein removing the guidewire from the catheter lumen includes applying a force less than 0.5 Ibf.

[0030] In some aspects, the techniques described herein relate to a method, wherein forming the guidewire body includes forming a monolithic wire extending longitudinally and defining a smooth outer surface.

[0031] In some aspects, the techniques described herein relate to a method, wherein forming the guidewire body includes forming a coil having a wire extending helically about a central longitudinal axis of the guidewire body.

[0032] In some aspects, the techniques described herein relate to a method, wherein forming the guidewire body includes forming a core wire extending along a central longitudinal axis and forming a coil having a wire extending helically about the core wire.

[0033] In some aspects, the techniques described herein relate to a method, wherein forming the lubricious coating includes forming a conformal layer disposed over the surface of the guidewire body at a thickness of between lpm-250pm.

[0034] In some aspects, the techniques described herein relate to a method, further including forming a catheter defining a lumen and applying a second coating to the catheter lumen, the second coating including an anti-microbial coating and wherein the lubricious coating mitigates migration of the second coating during transport or storage. .BRIEF DESCRIPTION OF DRAWINGS

[0035] A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0036] FIG. 1 shows an exemplary catheter and guidewire system, in accordance with embodiments disclosed herein.

[0037] FIG. 2 shows close-up detail of a distal portion of the catheter and guidewire system of FIG. 1, in accordance with embodiments disclosed herein.

[0038] FIG. 3 A shows an exemplary guidewire formed of a single core wire extending longitudinally, in accordance with embodiments disclosed herein.

[0039] FIG. 3B shows an exemplary coil guidewire formed of a wire extending helically about a central longitudinal axis, in accordance with embodiments disclosed herein.

[0040] FIG. 3C shows an exemplary coil-over- wire guidewire formed of a core wire extending longitudinally and a coil formed of a wire extending helically about the central core wire, in accordance with embodiments disclosed herein.

[0041] FIG. 4 shows close-up detail of a guidewire including a conformal lubricious coating disposed thereon, in accordance with embodiments disclosed herein.

[0042] FIG. 5A shows a schematic cross-section view of a guidewire including a conformal lubricious coating disposed thereon, in accordance with embodiments disclosed herein.

[0043] FIG. 5B shows a schematic cross-section view of a guidewire including a non- conformal lubricious coating disposed thereon, in accordance with embodiments disclosed herein.

[0044] FIG. 6 shows a chart indicating individual value plots of guidewire drag force, in accordance with embodiments disclosed herein.DESCRIPTION

[0045] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein. It is understood that the drawings are diagrammatic and schematicrepresentations of exemplary embodiments of the invention and are neither limiting nor necessarily drawn to scale.

[0046] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Also, the words “including,” “has,” and “having,” as used herein, including the claims, shall have the same meaning as the word “comprising.”

[0047] In the following description, the terms “or” and “and / or” as used herein are to be interpreted as inclusive or meaning any one or any combination. As an example, “A, B or C” or “A, B and / or C” mean “any of the following, A, B, C, A and B, A and C, B and C, A, B and C.” An exception to this definition will occur only when a combination of elements, components, functions, steps or acts are in some way inherently mutually exclusive.

[0048] With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a guidewire or system disclosed herein includes a portion of the guidewire or system intended to be near a clinician when the guidewire or system is used on a patient. Likewise, a “proximal length” of, for example, the guidewire or system includes a length of the guidewire or system intended to be near the clinician when the guidewire or system is used on the patient. A “proximal end” of, for example, the guidewire or system includes an end of the guidewire or system intended to be near the clinician when the guidewire or system is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the guidewire or system can include the proximal end of the guidewire or system; however, the proximal portion, the proximal end portion, or the proximal length of the guidewire or system need not include the proximal end of the guidewire or system. That is, unless context suggestsotherwise, the proximal portion, the proximal end portion, or the proximal length of the guidewire or system is not a terminal portion or terminal length of the guidewire or system.

[0049] With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a guidewire or system disclosed herein includes a portion of the guidewire or system intended to be near or in a patient when the guidewire or system is used on the patient. Likewise, a “distal length” of, for example, the guidewire or system includes a length of the guidewire or system intended to be near or in the patient when the guidewire or system is used on the patient. A “distal end” of, for example, the guidewire or system includes an end of the guidewire or system intended to be near or in the patient when the guidewire or system is used on the patient. The distal portion, the distal end portion, or the distal length of the guidewire or system can include the distal end of the guidewire or system; however, the distal portion, the distal end portion, or the distal length of the guidewire or system need not include the distal end of the guidewire or system. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the guidewire or system is not a terminal portion or terminal length of the guidewire or system.

[0050] To assist in the description of embodiments described herein, as shown in FIG. 2, a longitudinal axis extends substantially parallel to an axial length of the guidewire. A lateral axis extends normal to the longitudinal axis, and a transverse axis extends normal to both the longitudinal and lateral axes.

[0051] As used herein, a “turn” of a coil includes a wire extending helically through 360° about a central axis.

[0052] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

[0053] When placing catheters intravascularly, a catheter and guidewire system is often used to facilitate advancing the relatively flexible catheter through tortuous vascular pathways. The guidewire, having relatively greater columnar strength, is advanced through the tortuous vascular pathways to a target location. The catheter is either advanced concurrently with the guidewire, or is subsequently advanced over the guidewire until the distal tip is disposed at a target location within the vasculature. Exemplary catheters placed using a guidewire include peripheral intravenous catheter (PIVC), central venous catheter (CVC), peripherally inserted central catheter (PICC), rapidly insertable central catheters (RICC), or the like.

[0054] Once the distal tip of the catheter is placed at the target location, the guidewire is then withdrawn proximally from the lumen of the catheter. A drag force can occur between the guidewire and the inner surface of the catheter lumen, which can disturb the location of the catheter distal tip as the guidewire is removed. Various factors can affect the friction coefficient between the guidewire and the catheter, which in turn can affect the drag force required to remove the guidewire. For example, the presence or absence of certain coatings, such as antimicrobial coatings disposed on the guidewire, catheter or both, can increase the friction coefficient therebetween. In addition, mechanical properties, structural properties, or surface textures of the catheter and / or guidewire can affect the frictional coefficient.

[0055] FIGS. 1-2 show an exemplary catheter and guidewire system (“system”) 100 generally including a catheter 110 and a guidewire 120. As shown in FIG. 1, the system 100 can further include an advancement system 130 configured to advance one or both of the catheter 110 and the guidewire 120. FIG. 2 shows close-up detail of a distal portion of the system 100. In an embodiment, the catheter 110 includes a catheter body 112 extending between a proximal end and a distal tip 114 and defines one or more lumen. As shown in FIG. 2, the catheter body 112 includes a first lumen 116 extending to an opening disposed at the distal tip 114. The guidewire 120 includes an elongate body 122 extending to a distal tip 124 and can be slidably engaged with a lumen, e.g. the first lumen 116, of the catheter 110. Optionally, the guidewire body 122 includes an atraumatic tip 126 where a distal portion of the guidewire body is curved to mitigate damaging a vessel wall as the guidewire 120 is advanced distally. The atraumatic tip 126 can be elastically deformed to a linear shape when withdrawn into the catheter lumen 116.

[0056] FIGS. 3 A-3C show close-up detail of exemplary structures of a guidewire body122. FIG. 3A shows a solid-core wire guidewire 122A construction having a monolithic wire extending longitudinally. The outer surface of the solid-core wire guidewire 122A can define a smooth outer surface. Optionally the solid-core wire guidewire 122 A can include a textured surface engraved thereon. FIG. 3B shows a coil guidewire 122B construction having a wire extending helically about a central longitudinal axis of the guidewire body. The properties of the coil, such as coil diameter, outer diameter, inner diameter, wire diameter, pitch of the coil relative to the longitudinal axis, helix angle, number of turns per longitudinal length, longitudinal distance between adj acent turns of the wire, or the like, can vary to provide varying mechanical properties. The outer surface of the coil wire guidewire 122B can define a ribbedouter surface. As will be appreciated, depending on the number of turns per unit of longitudinal length, the coil can vary in the number of points of contact per longitudinal length between the outer surface of the coil and the inner surface catheter lumen. For example, a coil having a greater longitudinal distance between turns will have fewer points of contact per longitudinal length between the guidewire and the catheter, which in turn modifies the overall friction coefficient.

[0057] FIG. 3C shows a coil-over- wire guidewire 122C where a solid core wire extends longitudinally and includes a helical coil extending thereover. As will appreciated, varying the dimensions and properties of one or both of the solid core wire and the coil can vary the mechanical properties of the guidewire. For example, the solid core wire can provide increased rigidity and can support a coil having a greater longitudinal distance between turns of the coil, and reducing the number of contact points per unit longitudinal length. Further, the spacing between the turns of the coil can modify the texture of the outer surface of the coil. As will be appreciated a guidewire 120 can include one or more of these wire, coil, coil-over-wire structures along the longitudinal length thereof to provide varying mechanical properties. As will be appreciated, one or more of these features or structures of the guidewire 120 can affect the friction coefficient between the guidewire 120 and the catheter 110.

[0058] In an embodiment, the guidewire 120 includes a lubricious coating 140 to reduce the friction coefficient between the guidewire 120 and the catheter 110. In an embodiment, the guidewire 120 includes a lubricious coating 140 including a liquid silicone oil, a cured silicone lube, a parylene, or combinations thereof. FIG. 4 shows close-up detail of a coil guidewire, e.g. coil guidewire 122B or a coil-over-wire guidewire 122C, having a liquid silicone oil lubricious coating 142. In an embodiment, the liquid silicone oil coating 142 has a viscosity of between 50,000 and 1,500,000 centistokes (cSt). In an embodiment, the liquid silicone oil coating 142 has a viscosity of 1,000,000 cSt. As such, the liquid silicone oil has a very high viscosity.

[0059] Advantageously, the liquid silicone oil having a viscosity of between 50,000 cSt. and 1,500,000 cSt. displays a similar friction co-efficient to a liquid silicone oil of a more typical viscosity, for example, of around 50 cSt. To 500 cSt. However, the liquid silicone oil of between 50,000 cSt. and 1,500,000 cSt. significantly reduces the likelihood of migration of the coating during transport and storage while maintaining a similar friction coefficient as a liquid silicone oil having a more typical viscosity of around 50 cSt. To 500 cSt. Further, thehighly viscous liquid silicone oil coating, once deposited on the medical device, also remains a liquid during storage and transport.

[0060] In an exemplary method of coating the guidewire 120, the silicone oil lubricious coating 142 can be applied to the guidewire 120 by dissolving the silicone oil having a viscosity of 1,000,000 cSt in a solvent such as heptane. However, it will be appreciated that other alkane solvents, paraffins, saturated hydrocarbons, polar or non-polar solvents are also contemplated. The guidewire 120 can then be dipped into the solution for one or more dips, where each dip has a dwell time of between 1 seconds and 30 seconds. It will be appreciated, however, that greater or lesser numbers of dips and / or greater or lesser lengths of dwell times are also contemplated. Once removed from the solution, the volatility of the solvent allows for the solvent to evaporate off while leaving the solute deposited on the guidewire. As such, the silicon oil deposits onto the surface of the guidewire 120 to form a lubricious coating 142. In an embodiment, the lubricious coating 142 is between lpm-250pm thick, although greater and lesser thicknesses are contemplated.

[0061] FIG. 5A shows a longitudinal cross-section view of a coil-over-wire guidewire 122C having a conformal lubricious coating disposed thereon, for example, a conformal silicone oil lubricious coating 142. The coil-over-wire guidewire 122C includes a core wire 152 and a coil 154 disposed thereover. As shown, the coil 154 provides a ribbed outer surface of the guidewire 122C. A conformal lubricious coating, such as the silicone oil coating 142 disposed on the guidewire 122C by a dipping process, provides a coating that includes a uniform thickness (7) over the surface of the guidewire and conforms to the shape of the outer surface of the guidewire 122C. As such, shape of the outer surface of the lubricious coating matches the shape of the guidewire 122C. For example, where a guidewire includes a coil and provides a ribbed outer surface, the conformal lubricious coating also provides a ribbed outer surface.

[0062] Advantageously, the resulting ribbed outer shape of the lubricious coating 142 provides a reduced number of contact points between the coating 142 and the catheter 110. In an embodiment, this can further reduce the friction coefficient between the guidewire 120 / coating 142 assembly and the inner surface of the catheter lumen 116. Advantageously, the viscosity of the silicone oil mitigates migration of the lubricious coating during transport and storage, maintaining the shape and thickness of the coating 142. In an embodiment, the dipping application process provides a conformal coating layer on the guidewire.

[0063] FIG. 5B shows a longitudinal cross-section view of a coil-over-wire guidewire 122C having a non-conformal lubricious coating, e.g. a silicone oil coating 142, disposed thereon. The coil-over-wire guidewire 122C includes a core wire 152 and a coil 154 disposed thereover. As shown, the coil 154 provides a ribbed outer surface of the guidewire 122C. A non-conformal, by contrast with a conformal lubricious coating, provides a uniform or smooth outer surface and defines a minimum thickness ( / ) between the outer surface of the coating and the outer-most edge of the guidewire 122C. As such, the ribbed surface of the coil 154 are covered by the lubricious coating and the coating provides a smooth outer surface. As such, the non-conformal coating can minimize any surface texture, or “roughness,” which may affect the friction coefficient.

[0064] In an embodiment, the guidewire 120 includes a lubricious coating 140 having a curable silicone lube 144 disposed on the outer surface of the guidewire 120. The silicon lube 144 can be applied to the surface of the guidewire 120 using a dipping process, as described herein. The silicone lube 144 is dissolved in a solvent, such as heptane, or the like, and deposited on the surface of the guidewire by dipping the guidewire into the solution. Once the silicone lube 144 is deposited on the surface, the silicone lube 144 is then cured to ensure attachment to the guidewire surface and mitigate migration during storage and transport. Curing the silicone lube 144 includes one or more of an ultraviolet (“UV”) curing, a moisture curing, and a temperature curing process.

[0065] In an embodiment, a UV curing process includes exposing the coating to a UV radiation source, e.g. a UV light or the like, for a predetermined length of time. Exemplary UV curing includes exposing the lube to the UV irradiation source for between 1 second and 1 hour. However, greater or lesser exposure times are also contemplated. Exemplary UV irradiation sources include one or more of high-intensity UV sources (e.g., between 365-405 nm), UVA (320-400 nm), UVB (e.g., between 280-315 nm), and UVC (e.g., between 100- 280 nm). Exemplary UV intensities can include 100-200 mW / cm2. However, greater or lesser intensities are also contemplated. In an embodiment, the curing process further includes curing in an inert atmosphere (e.g., nitrogen). In an embodiment, the curing process requires one or more exposures at the same or different combinations of exposure times, wavelengths, intensities, or inert atmospheres, etc.

[0066] In an embodiment, moisture and / or temperature curing includes one or more exposures to a relative humidity (“RH”), range of RH, temperature, or range of temperaturesfor a predetermined length of time, or combinations thereof. Exemplary RH includes 40%- 70% RH. However, it will be appreciated that greater or lesser RH are also contemplated. Exemplary temperatures can include 20°C-250°C. However, it will be appreciated that greater or lesser temperatures are also contemplated. Exemplary exposure times can be between 30 seconds- 72 hours. However, it will be appreciated greater or lesser exposure times are also contemplated. For example, the coating can be exposed to a 60% RH at 180°C for 1 hour. In an embodiment, the curing process can further include a catalyst, or modifications to airflow.

[0067] Advantageously, the curing process of the silicone lube 144 mitigates migration of the coating 140 during transport and storage. Advantageously, the cured silicone lube coating 144 provides a reduced friction coefficient between the guidewire 120 and the catheter 110.

[0068] In an embodiment, the guidewire 120 includes a lubricious coating 140 including a polymer coating such as a parylene coating 146. The parylene coating 146 can be applied to the surface of the guidewire 120 through a vapor deposition process which would deposit a conformal layer of the parylene to the outside surface of the guidewire 120. In an embodiment, the parylene coating can be between 0.1pm and 5pm thick, although greater or lesser thicknesses are also contemplated. In an embodiment, the guidewire 120 can include a combination of one or more of a silicone oil coating 142, a cured silicone lube coating 144 and the polymer parylene coating 146.

[0069] FIG. 6 shows a chart 600 detailing unexpected results of guidewire drag force for various combinations of guidewire catheter systems 100. The chart 600 shows individual value plots of guidewire drag force and shows guidewire drag force 602 in pound-force (Ibf) on the y-axis and system configurations 604 on the x-axis.

[0070] Configuration “A” 610 are systems 100 including a catheter 110 having an antimicrobial coating disposed on the inner surface of the catheter lumen 116, and a high viscosity silicone oil lubricious coating 142 disposed on an outer surface of the guidewire 120. The guidewire 120 is disposed within the catheter lumen 116. Configuration “B” 612 are systems 100 including a catheter 110 having an antimicrobial coating disposed on the inner surface of the catheter lumen 116, and a guidewire 120 having no lubricious coating disposed thereon. Configuration “C” 614 are systems 100 including a catheter 110 having an antimicrobial coating disposed on the inner surface of the catheter lumen 116, and a curedsilicone lube coating 144 disposed on an outer surface of the guidewire 120. Configuration “D” 616 are control systems 100 and include a catheter 110 having no antimicrobial coating disposed on the inner surface of the catheter lumen 116, and no lubricious coating disposed on an outer surface of the guidewire 120.

[0071] As shown, configuration “A” 610 displays a drag force range of between 0. llbf- 0.251bf, with an average drag force of 0.1751bf. Configuration “B” 612 displays a drag force range of between 0.61bf-2.71bf, with an average drag force of 1.651bf. Configuration “C” 614 displays a drag force range of between 0.81bf-0.951bf, with an average drag force of 0.8751bf. Configuration “D” 616 displays a drag force range of between 0.251bf-0.41bf, with an average drag force of 0.3251bf.

[0072] Configuration “B” 612, including systems having an antimicrobial coating disposed on the inner surface of the catheter lumen 116 but no lubricious coating disposed on the guidewire 120, show a wide range of drag forces required to move the guidewire 120 relative to the catheter 110. The drag forces are also significantly increased from that of the control system, Configuration “D” 616. As such, the antimicrobial coating of the catheter 110 significantly increases the amount of force required to remove the guidewire 120 from the catheter 110. Moreover, the increased range of drag forces shows a large variability in drag force between individual systems 100 of the same configuration. This can be problematic because the user may not know how much force is required to remove the guidewire 120, or whether a force that is greater than expected is specific to the individual system 100 or indicative of a problem. If the user applies too much force, the catheter tip may be dislodged.

[0073] Advantageously, as shown by Configuration “C” 614, the addition of the cured silicone lube coating 144 greatly reduces the variation in drag force, providing a much- improved reliability in the amount of force required to remove the guidewire 120. Moreover, the average drag force required for Configuration “C” 614 is reduced relative to the average drag force of Configuration “B” 612. Advantageously, as shown by Configuration “A” 610, the addition of the highly viscose silicone oil coating 142 also greatly reduces the variation in drag force over that of Configuration “B”, providing a much-improved reliability in the amount of force required to remove the guidewire 120. Moreover, the average drag force required for Configuration “A” 610 is greatly reduced relative to both the average drag force of Configuration “B” 612, as well as Configuration “C” 614. Indeed, the average drag force of Configuration “A” 610 is lower than the average drag force of the control group, Configuration“D” 616. As such, the silicone oil coating 142 not only off sets the increased drag force of the antimicrobial coatings, but provides a reduced drag force over that of an uncoated catheter and guidewire system.

[0074] Advantageously, the use of the lubricant on the guidewire surface significantly reduced the friction coefficient between the inner surface of the catheter lumen and outer surface of the guidewire 120, relative to an uncoated guidewire with an antimicrobial coated catheter. The reduced drag mitigates disturbance of the catheter distal tip once placed. Further, the reduced variation in drag force provides a more reliable system improving clinician user experience.

[0075] When the catheter lumen includes an antimicrobial coating, the coating provides an increase in tackiness leading to an increase in overall drag force required to remove the guidewire, as well as an increase in variation in drag force leading to reduced reliability between systems 100. Advantageously, the addition of a lubricious coating 140, such as a high viscosity silicone oil coating 142, a cured silicon lubricant coating 144, or a parylene coating on the guidewire surface reduces the friction coefficient which results in much lower overall drag force, as well as a reduced variation in drag force, leading to increased reliability between systems. Advantageously, the addition of a lubricious coating, such as a high viscosity silicone oil coating 142, a cured silicon lubricant coating 144, or a parylene coating, stabilizes the antimicrobial coating on the catheter lumen surface and mitigates migration during storage and transport.

[0076] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and / or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and / or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMS1. A catheter and guidewire system, comprising: a guidewire having a body extending along a longitudinal axis between a proximal end and a distal tip; and a lubricious coating disposed on an outer surface of the guidewire body and including one or more of a liquid silicone oil, a curable silicone lube, and a parylene.

2. The catheter and guidewire system according to claim 1, wherein the liquid silicone oil has a viscosity of 1 million centistokes (cSt) and is configured to mitigate migration of the lubricious coating during transport or storage.

3. The catheter and guidewire system according to either of claims 1 or 2, wherein the guidewire body includes a monolithic wire extending longitudinally and defining a smooth outer surface.

4. The catheter and guidewire system according to either of claims 1 or 2, wherein the guidewire body includes a coil having a wire extending helically about a central longitudinal axis of the guidewire body.

5. The catheter and guidewire system according to either of claims 1 or 2, wherein the guidewire body includes a core wire extending along a central longitudinal axis and a coil having a wire extending helically about the core wire.

6. The catheter and guidewire system according to either of claims 4 or 5, wherein the coil includes a first turn extending through 360° and a second turn disposed adjacent the first turn in a longitudinally spaced apart relationship from the first turn.

7. The catheter and guidewire system according to either of claims 4 or 5, wherein the coil includes a first turn extending through 360° and a second turn disposed longitudinally adjacent to the first turn, and in contact with the first turn.

8. The catheter and guidewire system according to any of the preceding claims, wherein the lubricious coating is a conformal layer disposed over the surface of the guidewire body at a thickness of between lpm-250pm.

9. The catheter and guidewire system according to any one of claims 1-7, wherein the lubricious coating is a non-conformal layer disposed over the surface of the guidewire body at a minimum thickness of between lpm-250pm.

10. The catheter and guidewire system according to any of the preceding claims, further including a catheter defining a lumen and including a second coating, different from the lubricious coating, and disposed thereon.

11. The catheter and guidewire system according to claim 10, wherein the second coating is an anti-microbial coating and wherein the lubricious coating mitigates migration of the second coating during transport or storage.

12. The catheter and guidewire system according to either of claims 10 or 11, wherein the guidewire is configured to extend through the lumen of the catheter, an outer diameter of the guidewire being less than an inner diameter of the catheter lumen.

13. A method of placing a catheter, comprising: providing a catheter having a body extending along a longitudinal axis and defining a lumen; placing a guidewire within the catheter lumen, the guidewire comprising: a guidewire body extending between a proximal end and a distal tip; and a lubricious coating disposed on an outer surface of the guidewire body and including one or more of a liquid silicone oil, a curable silicone lube, and a parylene; advancing the catheter and the guidewire assembly to a target location within a body of a patient; and applying a force to the guidewire to withdraw the guidewire from the catheter lumen.

14. The method according to claim 13, wherein applying a force includes applying a force less than 0.5 Ibf.

15. The method according to either of claims 13 or 14, wherein the liquid silicone oil has a viscosity of 1 million centistokes (cSt) and is configured to mitigate migration of the lubricious coating during transport or storage.

16. The method according to any one of claims 13-16, wherein the guidewire body includes a monolithic wire extending longitudinally and defining a smooth outer surface.

17. The method according to any one of claims 13-16, wherein the guidewire body includes a coil having a wire extending helically about a central longitudinal axis of the guidewire body.

18. The method according to any one of claims 13-16, wherein the guidewire body includes a core wire extending along a central longitudinal axis and a coil having a wire extending helically about the core wire.

19. The method according to any one of claims 13-18, further including applying the lubricious coating to the guidewire body prior to placing the guidewire within the catheter lumen, by dipping the guidewire body into a solution including the lubricious coating dissolved in a solvent to form a conformal layer disposed over the surface of the guidewire body at a thickness of between lpm-250pm.

20. The method according to claim 19, wherein the solvent includes one or more of an alkane solvent, a paraffin, a saturated hydrocarbon, or heptane.

21. The method according to any one of claims 13-20, further including applying a second coating to the catheter lumen including an anti-microbial coating and wherein the lubricious coating mitigates migration of the second coating during transport or storage.

22. A method of making a catheter and guidewire system, comprising: forming a guidewire, comprising: forming a guidewire body extending along a longitudinal axis; and forming a lubricious coating on the outer surface of the guidewire by dipping the guidewire in a solution including a liquid silicone oil dissolved in a heptane solvent.

23. The method according to claim 22, wherein the lubricious coating including the liquid silicone oil has a viscosity of 1 million centistokes (cSt) and is configured to mitigate migration during transport and storage.

24. The method according to either of claims 22 or 23, further including placing guidewire in a lumen of a catheter body, and wherein removing the guidewire from the catheter lumen includes applying a force less than 0.5 Ibf.

25. The method according to any one of claims 22-24, wherein forming the guidewire body includes forming a monolithic wire extending longitudinally and defining a smooth outer surface.

26. The method according to any one of claims 22-24, wherein forming the guidewire body includes forming a coil having a wire extending helically about a central longitudinal axis of the guidewire body.

27. The method according to any one of claims 22-24, wherein forming the guidewire body includes forming a core wire extending along a central longitudinal axis and forming a coil having a wire extending helically about the core wire.

28. The method according to any one of claims 22-27, wherein forming the lubricious coating includes forming a conformal layer disposed over the surface of the guidewire body at a thickness of between lpm-250pm.

29. The method according to any one of claims 22-28, further including forming a catheter defining a lumen and applying a second coating to the catheter lumen, the second coating including an anti-microbial coating and wherein the lubricious coating mitigates migration of the second coating during transport or storage.

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