Flexible Locking Microcatheter and Guidewire Coaxial System

Abstract

A catheter system in which the length of a guidewire extending distally from the distal tip of the catheter can be adjusted and / or the guidewire can be secured to a catheter hub so as to simultaneously steer the guidewire and catheter. The catheter system can include a catheter having an elongate shaft defining a catheter lumen, a hub assembly coupled to a proximal end of the elongate shaft and including a hub assembly lumen, a torque assembly releasably coupled to the hub assembly and including a torque assembly lumen, and a guidewire coaxially disposed within the catheter lumen, the hub assembly lumen, and the torque assembly lumen. The torque assembly can be configured to simultaneously apply torque to the elongate shaft and the guidewire in a first configuration and to apply torque to the guidewire independently of the elongate shaft in a second configuration.

Description

[Technical Field]

[0001] This application relates generally to torque devices, and more particularly to integrated torque and rotation hemostatic valves. This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 410,071, filed September 26, 2022, the entire disclosure of which is incorporated herein by reference. [Background technology]

[0002] Microcatheters can be used in selective interventional endovascular procedures to reach target vessels and administer various therapies. Microcatheters can be traced along a guidewire to reach the target site. Generally, a guidewire can be a steerable device in which a clinician uses an external torque device to steer the guidewire to the target location. Typical preparation of a microcatheter and guidewire system can include activating the hydrophilic coating by flushing and soaking the microcatheter in saline. The microcatheter can then be loaded onto the guidewire and inserted into the guide catheter hub. During the procedure, the guidewire can be advanced in parallel with the microcatheter. The length of the guidewire extending distally from the distal end of the microcatheter can be adjusted according to clinical needs. The guidewire can be torqued by the clinician for effective and precise tracing of the microcatheter to the target site. In some cases, microcatheters can be available as coaxial systems with pre-loaded guidewires. Generally, there are two types of pre-assembled systems: Both the first and second preassembly systems may have limitations. For example, the first preassembly system limits the length of the guidewire extending distally from the distal tip of the microcatheter and cannot exceed a certain predetermined amount. While the second preassembly system allows for an adjustable length of the guidewire extending distally from the distal tip of the microcatheter, it does not allow for the guidewire to be locked to the hemostatic hub to allow simultaneous torqueing of the microcatheter and the guidewire. There remains a need to provide alternative medical devices and alternative methods for manufacturing and using medical devices. Summary of the Invention

[0003] The present disclosure provides design, material, manufacturing method, and use alternatives for medical devices. In a first embodiment, a catheter system may include a catheter having an elongate shaft extending from a proximal end to a distal end, the elongate shaft defining a catheter lumen extending from the proximal end to the distal end, a hub assembly coupled to the proximal end of the elongate shaft, the hub assembly including a hub assembly lumen in fluid communication with the catheter lumen, a torque assembly releasably coupled to the hub assembly, the torque assembly including a torque assembly lumen in selective fluid communication with the hub assembly lumen, and a guidewire coaxially disposed within the catheter lumen, the hub assembly lumen, and the torque assembly lumen. The torque assembly may be configured to simultaneously apply torque to the elongate shaft and the guidewire in a first configuration and to apply torque to the guidewire independently of the elongate shaft in a second configuration.

[0004] Alternatively or additionally to the above embodiments, in another embodiment, the length of the guidewire extending distally from the distal end of the elongate shaft may be adjustable. Alternatively or additionally to any of the above embodiments, in another embodiment, the torque assembly may be coupled to the hub assembly in the first configuration.

[0005] Alternatively or additionally to any of the above embodiments, in another embodiment, the torque assembly may be decoupled from the hub assembly in the second configuration. Alternatively or additionally to any of the above embodiments, in another embodiment, the torque assembly may include a rotatable valve, a body, a collet, and an actuatable cap.

[0006] Alternatively or additionally to any of the above embodiments, in another embodiment, the rotatable valve may include a first coupling portion rotatably coupled to a second coupling portion, the second coupling portion being configured to rotate independently of the first coupling portion when the first coupling portion is held in a fixed position.

[0007] Alternatively or additionally to any of the above embodiments, in another embodiment, in the first configuration, the torque assembly can be configured to apply torque to the guidewire independently of the elongate shaft of the catheter when the first coupling portion is held in the fixed position.

[0008] Alternatively or additionally to any of the above embodiments, in another embodiment, a distal end region of the body may be fixedly attached to the second coupling portion. Alternatively or additionally to any of the above embodiments, in another embodiment, the collet may be configured to be selectively locked to the guidewire.

[0009] Alternatively or additionally to any of the above embodiments, in another embodiment, the actuatable cap may be actuated to selectively lock the collet to the guidewire.

[0010] Alternatively or additionally to any of the above embodiments, in another embodiment, the actuatable cap may be configured to lock the collet to the guidewire by selectively biasing a proximal end region of the collet radially inward.

[0011] Alternatively or additionally to any of the above embodiments, in another embodiment, once the guidewire is unlocked from the collet, the guidewire can be actuated independently of the torque assembly.

[0012] Alternatively or additionally to any of the above embodiments, in another embodiment, the body may include an irrigation port in fluid communication with the torque assembly lumen. Alternatively or additionally to any of the above embodiments, in another embodiment, the torque assembly may further include a hemostatic seal.

[0013] Alternatively or additionally to any of the above embodiments, in another embodiment the hemostatic seal may be configured to form a fluid-tight seal between the guidewire and the body of the torque assembly.

[0014] In another example, a catheter system may include a catheter having an elongate shaft extending from a proximal end to a distal end, the elongate shaft defining a catheter lumen extending from the proximal end to the distal end, a hub assembly coupled to the proximal end of the elongate shaft, the hub assembly including a hub assembly lumen in fluid communication with the catheter lumen, a torque assembly releasably coupled to the hub assembly, the torque assembly including a rotatable valve, a body, a collet, and an actuatable cap, the torque assembly including a torque assembly lumen in selective fluid communication with the hub assembly lumen, and a guidewire coaxially disposed within the catheter lumen, the hub assembly lumen, and the torque assembly lumen, the guidewire being selectively secured relative to the torque assembly. The torque assembly may be configured to apply torque to the elongate shaft and the guidewire simultaneously in a first configuration and to apply torque to the guidewire independently of the elongate shaft in a second configuration. The length of the guidewire extending distally from the distal end of the elongate shaft may be adjustable.

[0015] Alternatively or additionally to any of the above embodiments, in another embodiment, the torque assembly may further include a hemostatic seal. Alternatively or additionally to any of the above embodiments, in another embodiment, the torque assembly may be coupled to the hub assembly in the first configuration and may be decoupled from the hub assembly in the second configuration.

[0016] Alternatively or additionally to any of the above embodiments, in another embodiment, the rotatable valve may include a first coupling portion rotatably coupled to a second coupling portion. The second coupling portion may be configured to rotate independently of the first coupling portion when the first coupling portion is held in a fixed position. In the first configuration, the torque assembly may be configured to apply torque to the guidewire independently of the catheter elongate shaft when the first coupling portion is held in the fixed position.

[0017] In another example, a catheter system may include a catheter having an elongate shaft extending from a proximal end to a distal end, the elongate shaft defining a catheter lumen extending from the proximal end to the distal end, a hub assembly coupled to the proximal end of the elongate shaft, the hub assembly including a hub assembly lumen in fluid communication with the catheter lumen, a torque assembly releasably coupled to the hub assembly, the torque assembly including a rotatable valve including a first coupling portion rotatably coupled to a second coupling portion, a body, a collet, and an actuatable cap, the torque assembly including a torque assembly lumen in selective fluid communication with the hub assembly lumen, and a guidewire coaxially disposed within the catheter lumen, the hub assembly lumen, and the torque assembly lumen and selectively secured relative to the torque assembly. The torque assembly may be coupled to the hub assembly in a first configuration and configured to simultaneously apply torque to the elongate shaft and the guidewire. The torque assembly may be configured to apply a torque to the guidewire independently of the elongate shaft while being decoupled from the hub assembly in a second configuration. The length of the guidewire extending distally from the distal end of the elongate shaft may be adjustable. In the first configuration, the torque assembly may be configured to apply a torque to the guidewire independently of the elongate shaft of the catheter when the first coupling portion is held in a fixed position.

[0018] The above summary of some embodiments is not intended to describe each embodiment or every implementation of the present disclosure. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 is a perspective view of an exemplary catheter and torque assembly in a first configuration. [Figure 2]FIG. 2 is a cross-sectional view of an exemplary catheter and torque assembly taken along line 2-2 of FIG. [Figure 3] FIG. 3 is a perspective view of the exemplary catheter and torque assembly of FIG. 1 in a second configuration. DETAILED DESCRIPTION OF THE INVENTION

[0020] The present disclosure can be more fully understood in consideration of the following detailed description of various embodiments in conjunction with the drawings, in which: While the present disclosure is susceptible to various modifications and alternative forms, specific forms thereof have been shown by way of example in the drawings and are described in detail below. However, the aspects of the present disclosure are not intended to be limited to the particular embodiments described. Rather, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0021] All numerical values, whether expressly stated herein or not, are assumed to be modified by the term "about." The term "about" refers to a range of numerical values ​​that one of ordinary skill in the art would generally consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant figure.

[0022] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although certain preferred dimensions, ranges, and / or values ​​for various components, features, and / or specifications are disclosed, those skilled in the art, having access to this disclosure, will understand that the desired dimensions, ranges, and / or values ​​may deviate from those expressly disclosed.

[0023] As used in this specification and claims, the singular form "a," "an," or "an" includes plural referents unless the content clearly dictates otherwise. As used in this specification and claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0024] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings are not necessarily to scale, and the detailed description and drawings depict exemplary embodiments and are not intended to limit the scope of the present disclosure. The exemplary embodiments shown are intended to be exemplary only. Selected features of any exemplary embodiment may be incorporated into additional embodiments, unless expressly stated otherwise.

[0025] Microcatheters can be used in selective interventional endovascular procedures to reach target vessels and administer various therapies. The microcatheter can be traced along a guidewire to reach the target site. Generally, the guidewire can be a steerable device in which the clinician uses an external torque device to steer the guidewire to the target location. Typical preparation of a microcatheter and guidewire system can include activating the hydrophilic coating by flushing and soaking the microcatheter in saline. The microcatheter can then be loaded onto the guidewire and inserted into the guide catheter hub. During the procedure, the guidewire can be advanced in parallel with the microcatheter. The length of the guidewire extending distally from the distal end of the microcatheter can be adjusted according to clinical needs. The guidewire can be torqued by the clinician for effective and precise tracing of the microcatheter to the target site. In some cases, the microcatheter can be available as a coaxial system with a pre-loaded guidewire (e.g., a guidewire extending coaxially within the microcatheter). Generally, there can be two types of pre-assembled systems.

[0026] In a first pre-assembled system, the microcatheter and guidewire hub may be locked together. This system may have a length of guidewire extending distally from the distal end of the microcatheter. This system may allow a fixed molded hub and / or torque device at the proximal end of the guidewire to be locked to the proximal hub of the microcatheter, thereby tightly securing the guidewire to the microcatheter. However, this system does not provide the clinician the flexibility to advance or retract the guidewire ahead of the distal tip of the microcatheter depending on comfort and anatomical requirements during the procedure. For example, the length of the guidewire extending distally from the distal end of the microcatheter may not be adjustable. In this configuration, the fixed and / or molded hub at the proximal end of the guidewire may have a female Luer lock at its proximal end, allowing the clinician to simultaneously flush the microcatheter lumen and the guidewire.

[0027] In a second pre-assembly system, the entire length of the guidewire can be preloaded into the lumen of the microcatheter without a fixed locking mechanism, with the guidewire being adjustable and / or flexible relative to the microcatheter. This may require a separate secondary torque device to effectively rotate the guidewire. Also, a separate hemostatic valve can be attached to the proximal hub of the microcatheter to flush the microcatheter before use. This may be required because a torque device located at the proximal end of the guidewire may not have a mechanism for flushing the guidewire or microcatheter. The same hemostatic valve can be used during the procedure to prevent blood loss and to allow the physician to lock the embolic coil sheath for easy transfer of the coil from the sheath to the microcatheter hub.

[0028] Both the first and second preassembly systems described herein may have limitations. For example, the first preassembly system limits the length of the guidewire extending distally from the distal tip of the microcatheter and cannot exceed a predetermined amount. The second preassembly system allows the length of the guidewire extending distally from the distal tip of the microcatheter to be adjustable, but does not allow the guidewire to be locked to the hemostatic hub to allow simultaneous torqueing of the microcatheter and guidewire. The present disclosure is directed to a microcatheter and guidewire system that allows the length of the guidewire extending distally from the distal tip of the microcatheter to be adjustable, while also allowing the guidewire to be fixed relative to the microcatheter hub to allow simultaneous steering of the guidewire and microcatheter.

[0029] FIG. 1 is a perspective view of an exemplary catheter system 10 according to one embodiment of the present disclosure. The system 10 may generally include a catheter 12, a torque assembly 14, and a guidewire 16. The catheter 12 may be one of a variety of different catheters. In some cases, the catheter 12 may be an intravascular catheter. Some examples of intravascular catheters include microcatheters, drug delivery catheters, diagnostic catheters, and guide catheters. While FIG. 1 illustrates a microcatheter, the present disclosure is not limited thereto. The catheter 12 may be manufactured using conventional techniques.

[0030] The catheter 12 may be sized depending on its intended use. For example, the catheter 12 may have a length ranging from about 50 to 200 centimeters and a diameter ranging from about 1.7 French (F), although in certain applications it may be as large as about 12 F.

[0031] In the illustrated embodiment, the catheter 12 may include an elongate shaft 18 having a proximal end 20 and a distal end 22. A hub assembly 24 may be connected to or disposed about the proximal end 20 of the elongate shaft 18. The hub assembly 24 may be secured to the catheter shaft 18 at the proximal end 20 of the shaft 18 using any suitable technique, for example, by adhesives, friction fit, mechanical fit, chemical bonding, thermal bonding, heat shrink material, molding, casting, welding (e.g., resistance or laser welding), soldering, brazing, use of an outer sleeve or polymer layer to join or connect components, or combinations thereof. In some embodiments, the distal end of the hub assembly 24 may be cast, molded, or molded onto the proximal end 20 of the shaft 18 so as to be connected to the proximal end 20. In other embodiments, the hub assembly 24 may be formed as a separate component and attached (e.g., glued, press-fit, etc.) to the proximal end 20 of the catheter shaft 18. In some cases, the hub assembly 24 may include a strain relief 26, although this is not required. The strain relief 26, if provided, may reduce twisting.

[0032] Guidewire 16 extends from proximal end 15 to distal end 17. Guidewire 16 may extend through a lumen of torque assembly 14, a lumen 48 of hub assembly 24, and a lumen of elongate shaft 18. Distal end 17 of guidewire 16 may extend distally beyond distal end 22 of elongate shaft 18. The length L of guidewire 16 that extends distally beyond distal end 22 of elongate shaft 18 may be increased or decreased as desired. In some cases, proximal end 15 of guidewire 16 may extend proximally from the proximal end of torque assembly 14, but this is not necessarily required.

[0033] The torque assembly 14 may include, among other components, a rotary valve 28, a body 30, and a movable cap 32. The torque assembly may be configured to accept guidewires and devices up to approximately 4F in diameter. As described in detail herein, the movable cap 32 may be actuated to selectively secure the guidewire 16 relative to the torque assembly 14. For example, when the cap 32 is in a first configuration, the guidewire 16 may be translated proximally and / or distally along the longitudinal axis of the torque assembly 14. When the cap 32 is in a second configuration, axial translation of the guidewire 16 within the torque assembly 14 is prevented. In some cases, the torque assembly 14 may be axially translated with the cap 32 in the second configuration to axially translate the guidewire 16 relative to the catheter 12. A side flushing port 34 may be provided in the body 30 for flushing the catheter 12 and / or guidewire 16. Although not explicitly shown, the irrigation port 34 may include tubing to facilitate attachment of a syringe to the irrigation port 34. In some embodiments, the irrigation port 34 may be omitted. In another example, the body 30 may further include one or more hemostatic ports. The one or more hemostatic ports may provide options to the clinician.

[0034] Details of the torque assembly 14 are shown in Figure 2, which is a cross-sectional view of the exemplary catheter system 10 taken along line 2-2 in Figure 1. Generally, the torque assembly 14 may be coupled to the guidewire 16 such that axial and / or rotational motion of the torque assembly 14 may be transferred to the guidewire 16. Additionally, the torque assembly 14 may be selectively coupled to the hub assembly 24 such that axial and / or rotational motion of the torque assembly 14 may be selectively transferred to the hub assembly 24 and the elongate shaft 18. As described in detail herein, the torque assembly 14 may be coupled to the hub assembly 24 such that rotation of the torque assembly 14 is not necessarily transferred to the hub assembly 24 and the elongate shaft 18.

[0035] The rotary valve 28 may include a first connector portion 36, a second connector portion 38, and a coupling portion 40. The rotary valve 28 and its components may be formed from a thermoplastic polymer. Some exemplary thermoplastic polymers include, but are not limited to, polyethylene (PE), polypropylene (PP), polymethyl methacrylate (PMMA), polyvinyl chloride (PVC), polyamide, acrylonitrile butadiene styrene (ABS), and polycarbonate. Other materials, such as, but not limited to, other polymers, metals, metal alloys, ceramics, and composites, may also be used as desired. The distal end portion 42 of the first connector portion 36 may be configured to be releasably coupled to the proximal end region of the hub assembly 24 of the elongate shaft 18. The distal end portion 42 of the first connector portion 36 may include an outer tubular member 44 and an inner tubular member 46. An annular opening may be defined between the outer tubular member 44 and the inner tubular member 46. The inner tubular member 46 may be sized and shaped to be disposed within the lumen 48 of the hub assembly 24. In some cases, the inner tubular member 46 may be configured to form a friction fit with the lumen 48 of the hub assembly 24. For example, the outer surface of the inner tubular member 46 may be configured to engage with the inner surface of the hub assembly 24. Other releasable coupling mechanisms, such as, but not limited to, a snap fit, a threaded engagement, a bayonet-type mechanism, etc., may also be used as desired. Once the inner tubular member 46 is coupled with the hub assembly 24, rotation of the first connector portion 36 may result in rotation of the hub assembly 24 and the elongate shaft 18.

[0036] The proximal end portion 52 of the second connector portion 38 may be configured to be coupled to the distal end region 54 of the body 30. The second connector portion 38 may be generally tubular and may define a lumen extending from the proximal end portion 52 to the distal end of the second connector portion 38. The lumen is coupled to the lumen of the inner tubular member 46 of the first connector portion 36, defining a lumen 66 that extends from the proximal end of the rotary valve 28 to the distal end of the rotary valve 28. The lumen 66 may be configured to receive the guidewire 16 therein. The lumen of the second connector portion 28 may be sized and shaped to receive the distal tubular extension 56 of the body 30. The distal tubular extension 56 may be secured to the second connector portion 38 such that movement of the body 30 is transmitted to the second connector portion 38. For example, the body 30 and the second connector portion 38 may be coupled such that rotation of the body 30 results in corresponding rotation of the second connector portion 38 and axial movement of the body 30 results in corresponding axial movement of the second connector portion 38. In some cases, the distal tubular extension 56 may be secured to the first connector portion 36 using any suitable technique, such as, for example, adhesives, friction fit, mechanical fit, chemical bonding, thermal bonding, heat shrink material, molding, casting, welding (e.g., resistance or laser welding), soldering, brazing, use of an outer sleeve or polymer layer to join or connect components, or combinations thereof.

[0037] The coupling portion 40 may be a generally annular ring configured to operably couple the first connector portion 36 and the second connector portion 38. A proximal end region 50 of the first connector portion 36 may be rotatably coupled to the distal end of the coupling portion 40 and / or the second connector portion 38, while an inner surface 58 of the coupling portion 40 may be fixedly attached to the second connector portion 38. The second connector portion 38 and the coupling portion 40 may be coupled such that the second connector portion 38 moves with the coupling portion 40, or vice versa. In some situations, the first connector portion 36 may be configured to rotate with the coupling portion 40 and / or the second connector portion 38, while in other situations, the first connector portion 36 may be configured to remain stationary while the coupling portion 40 and / or the second connector portion 38 rotate. For example, a clinician may grasp the first connector portion 36 to hold the first connector portion 36 in a stationary position while the coupling portion 40 and / or the second connector portion 38 are rotated. When the first connector portion 36 is held stationary, rotation of the torque assembly 14 is not transmitted to the hub assembly 24 and the elongate shaft 18. This allows the clinician to apply torque to the guidewire 16 independently of the elongate shaft 18. In some cases, an O-ring or other sealing member 60 may be disposed between the first connector portion 36 and the second connector portion 38. When the first connector portion 36 is released from the clinician's grasp, the first connector portion 36 can rotate with the second connector portion 38 such that rotation of the torque assembly 14 is transmitted to both the guidewire 16 and the elongate shaft 18, allowing torque to be applied to both the guidewire 16 and the elongate shaft 18 simultaneously.

[0038] The body 30 may extend proximally from the distal end region 54 to the proximal end region 62. The body 30 may be formed from a thermoplastic polymer. Some exemplary thermoplastic polymers include, but are not limited to, polyethylene (PE), polypropylene (PP), polymethyl methacrylate (PMMA), polyvinyl chloride (PVC), polyamide, acrylonitrile butadiene styrene (ABS), and polycarbonate. Other materials, such as, but not limited to, other polymers, metals, metal alloys, ceramics, and composites, may also be used as desired. The lumen 64 may extend from the proximal end to the distal end of the body 30. A distal portion of the lumen 64 is configured to communicate with the lumen 66 of the rotary valve 28. In some cases, the lumen 64 may have a first diameter adjacent the proximal end region 62 of the body 30 and a second, smaller diameter adjacent the distal end region 54 of the housing. The transition region 94 may extend between the first diameter and the second diameter. The lumen 64 may be configured to receive the guidewire 16 therein. The flushing port 34 may be in fluid communication with the lumen 66 and the lumen 64 to allow for flushing of the guidewire 16 and / or the elongate shaft 18 prior to use or to allow for the introduction of a treatment or device. The outer surface of the body 30 may be textured or otherwise include features to enhance the grip of the body 30. In some embodiments, the textured outer surface may include a plurality of ridges 68 and a plurality of recesses 70. The recesses 70 may extend less than the entire thickness of the body 30 or may extend less than half the thickness of the body 30. The textured surface may extend along less than the entire length of the body 30. The outer surface of the proximal end region 62 of the body 30 may include a plurality of threads 72. The plurality of external threads 72 may be configured to threadably engage corresponding internal threads 74 of the cap 32 .

[0039] The collet 76 may be disposed at least partially within the lumen 64 of the body 30 adjacent the proximal end region 62 of the body 30. The collet 76 may be formed from a thermoplastic polymer or a metal. Some exemplary thermoplastic polymers include, but are not limited to, polyethylene (PE), polypropylene (PP), polymethyl methacrylate (PMMA), polyvinyl chloride (PVC), polyamide, acrylonitrile butadiene styrene (ABS), and polycarbonate. Other materials, such as, but not limited to, other polymers, metals, metal alloys, ceramics, and composites, may also be used as desired. In some cases, the collet 76 may be securely secured to the body 30 using any suitable technique, such as, for example, adhesives, friction fit, mechanical fit, chemical bonding, thermal bonding, heat shrink material, molding, casting, welding (e.g., resistance or laser welding), soldering, brazing, the use of an outer sleeve or polymer layer to join or connect components, or a combination thereof. In some cases, the collet 76 and the body 30 may include a mechanical interlock, such as, but not limited to, a pair of mating ridges 83a, 83b, to prevent disengagement of the collet 76 from the body 30.

[0040] The collet 76 may define a lumen 78 extending from its proximal end to its distal end. The lumen 78 may be in communication with the lumen 64 of the body 30. A proximal end region 80 of the collet 76 may be configured to selectively engage or grip the outer surface of the guidewire 16 to secure the guidewire 16 to the torque assembly 14, thereby translating movement of the torque assembly 14 to the guidewire 16. For example, the proximal end region 80 may include a pair of deflectable arms 81 a, 81 b (collectively 81) configured to be deflected radially inward to grip the guidewire 16. For example, as described in more detail herein, the cap 32 may be actuated to deflect the arms 81 to grip the guidewire 16. A hemostatic seal 92 may be disposed between the distal end of the collet 76 and a transition region 94 of the lumen 64 of the body 30. The hemostatic seal 92 may be configured to prevent blood and / or other fluids from exiting the proximal end of the torque assembly 14. Hemostatic seal 92 may be formed from flexible rubber, silicone, elastomer, or the like such that a fluid-tight seal may be formed by hemostatic seal 92 between guidewire 16 and body 30 .

[0041] The cap 32 may be disposed over the proximal end region 62 of the body 30 and the proximal end region 80 of the collet 76. The cap 32 may define a lumen 82 extending from a proximal end 84 to a distal end 86 of the cap 32. The lumen 82 may have a first diameter adjacent the proximal end 84 and a second diameter adjacent the distal end 86. The second diameter may be larger than the first diameter. The lumen 82 may include a sloped transition region 88 located between the first and second diameters. The transition region 88 may provide a gradual transition from the first diameter to the second diameter. In some cases, this gradual transition may have a slope or angle that generally mates with a sloped outer surface 90 of the proximal end of the collet 76 to facilitate axial movement of the cap 32 relative to the collet 76. In a radially unbiased configuration, the arms 81 of the collet 76 may have an outer diameter that is larger than the first diameter of the lumen 82 of the cap 32 and larger than the proximal portion of the transition region 88.

[0042] As described herein, the cap 32 may include a plurality of internal threads 74 configured to threadably engage the external threads 72 of the body 30. It is contemplated that rotation of the cap 32 relative to the body 30 may cause the cap 32 to move axially along the longitudinal axis of the torque assembly 14. Rotation of the cap 32 in a first direction may cause the cap 32 to move distally relative to the body 30. This may cause the inner surface of the transition region 88 and / or the region of the lumen 78 having the first diameter to contact the outer surface 90 of the proximal end of the collet 76. Further distal movement of the cap 32 may cause the transition region 88 to bias the arms 81 inward to grip the guidewire 16. When the collet 76 is locked to the guidewire 16, actuation of the body 30 and / or cap 32 is transmitted to the guidewire 16. Rotation of the cap 32 in a second direction opposite the first direction may cause the cap 32 to move proximally relative to the body 30. This allows the arms 81 of the proximal end region 80 to expand, thereby releasing the guidewire 16. Once the guidewire 16 is released from the collet 76, the guidewire 16 can be axially displaced proximally and / or distally along the longitudinal axes of the torque assembly 14 and elongate shaft 18, independent of the torque assembly 14 and / or elongate shaft 18. When the clinician desires to adjust the length L of the guidewire 16 extending distally from the distal end 22 of the elongate shaft 18, the cap 32 can be actuated to release the biasing force of the arms 81 of the collet 76. The guidewire 16 can then be retracted proximally or advanced distally, as desired. Once the desired length L of the guidewire 16 extends distally beyond the distal end 22 of the elongate shaft 18, the cap 32 can be actuated to bias the arms 81 of the collet 76 radially inward, thereby gripping the guidewire 16 and securing the guidewire 16 to the torque assembly 14.

[0043] In use, the guidewire 16 and the elongate shaft 18 can be torqued together or individually. To torque both the guidewire 16 and the elongate shaft 18 simultaneously, the torque assembly 14 can be locked to the hub assembly 24 of the elongate shaft 18 and a cap 32 locked to the guidewire 16, as shown in FIG. 1 . For example, a rotary valve 28 can be coupled to the hub assembly 24. The cap 32 can also be actuated (e.g., advanced distally) to lock the torque assembly 14 to the guidewire 16 by deflecting the arms 81 of the collet 76 radially inward. With the torque assembly 14 locked to both the guidewire 16 and the elongate shaft 18, both the guidewire 16 and the elongate shaft 18 move together. For example, the guidewire 16 and the elongate shaft 18 can be retracted proximally together, advanced distally together, and / or torqued together.

[0044] In some cases, it may be desirable to torque the guidewire 16 to separate from the elongate shaft 18 (or vice versa). In one example, the torque assembly 14 may be locked to the hub assembly 24 of the elongate shaft 18 and a cap 32 locked to the guidewire 16. Rotation of the hub assembly 24 and elongate shaft 18 may be prevented by a clinician holding the first connector portion 36 of the rotary valve 28 to prevent rotation of the first connector portion 36. Torque can then be applied to the guidewire 16 by rotating the body 30. For example, as described above, the second connector portion 38 may be coupled to the body 30 such that movement of the body 30 is transferred to the second connector portion 38. When the first connector portion 36 is grasped by the clinician, rotation of the body 30 may rotate the second connector portion 38 while the first connector portion 36, hub assembly 24, and elongate shaft 18 remain stationary.

[0045] In another example, as shown in FIG. 3 , the torque assembly 14 can be unlocked from the hub assembly 24. FIG. 3 shows a perspective view of the catheter system 10 with the torque assembly 14 unlocked from the hub assembly 24. With the collet 76 locked to the guidewire 16 and the torque assembly 14 unlocked from the hub assembly 24, the torque assembly 14 can be rotated and / or axially displaced to apply torque to or axially displace the guidewire 16 without simultaneously moving the elongate shaft 18. In some cases, the torque assembly 14 can be unlocked from the hub assembly to adjust the length L of the guidewire 16 that extends distally beyond the distal end 22 of the elongate shaft 18. For example, unlocking the torque assembly 14 from the hub assembly 24 can decrease the length L of the guidewire 16 that extends distally beyond the distal end 22 of the elongate shaft 18. If desired, the length L of the guidewire 16 extending distally beyond the distal end 22 of the elongate shaft 18 can be further adjusted by releasing the collet 76, moving the guidewire 18, and relocking the collet 76 to the guidewire 18.

[0046] The various components of the medical devices and / or systems (and / or other systems disclosed herein) and materials that can be used for the various elements thereof disclosed herein may include those commonly associated with medical devices. For purposes of brevity, this description refers to catheter system 10. However, this is not intended to limit the devices and methods described herein, and this description may also apply to other elements, members, components, or devices disclosed herein, such as, but not limited to, elongate shaft 18 and torque assembly 14, and / or elements or components thereof.

[0047] In some embodiments, the catheter system 10 and / or its components may be made from metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, etc., or any other suitable material.

[0048] Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether-esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf Atochem® available from Bayer), and the like. CRISTAMID® available from Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex® high density polyethylene, Marlex® low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (EMS American GrillonExamples of suitable materials include GRILAMID® available from Grilon, Inc., perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, blends, combinations, copolymers thereof, polymer / metal composites, and the like.

[0049] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steel, mild steel, nickel-titanium alloys such as linear elastic and / or superelastic Nitinol, other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, HASTELLOY® C27®, and the like). 6 (registered trademark), other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N®), nickel-molybdenum alloys (e.g., HASTELLOY® ALLOY B2®, etc.), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®), platinum-enriched stainless steel, titanium, combinations thereof, or any other suitable material.

[0050] Some commercially available nickel-titanium or nitinol alloy families may exhibit useful mechanical properties that are chemically similar to, but distinct from, traditional shape memory and superelastic varieties, a category known as "linear elastic" or "non-superelastic." Linear elastic and / or non-superelastic nitinol may be distinguished from superelastic nitinol in that it does not exhibit a substantial "superelastic plateau" or "flag region" in its stress / strain curve as does superelastic nitinol. Instead, linear elastic and / or non-superelastic nitinol continues to increase stress substantially linearly with increasing recoverable strain, or in a somewhat linear relationship, though not necessarily perfectly linear, until plastic deformation begins, or at least in a more linear relationship than the superelastic plateau and / or flag region seen in superelastic nitinol. Therefore, for purposes of this disclosure, linear elastic and / or non-superelastic nitinol may also be referred to as "substantially" linear elastic and / or non-superelastic nitinol.

[0051] In some cases, superelastic nitinol can be distinguished from superelastic nitinol in that it can tolerate up to about 8% strain before plastic deformation, whereas linear elastic and / or non-superelastic nitinol can tolerate up to about 2-5% strain while remaining substantially elastic (e.g., before plastic deformation). Both of these materials can be distinguished from other linear elastic materials, such as stainless steel, which can only tolerate about 0.2-0.44% strain before plastic deformation (which can also be distinguished based on their composition).

[0052] In some embodiments, a linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not exhibit any martensite / austenite phase changes detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) over a wide temperature range. For example, in some embodiments, a linear elastic and / or non-superelastic nickel-titanium alloy does not have any martensite / austenite phase changes detectable by DSC and DMTA in the range of about -60 degrees Celsius to about 120 degrees Celsius. Therefore, the mechanical bending properties of such materials may generally be largely unaffected by temperature over this very wide temperature range. In some embodiments, the mechanical bending properties of a linear elastic and / or non-superelastic nickel-titanium alloy at ambient or room temperature are substantially the same as those at body temperature, e.g., in that they do not exhibit a superelastic plateau and / or flag region. In other words, a linear elastic and / or non-superelastic nickel-titanium alloy maintains its linear elastic and / or non-superelastic properties and / or characteristics over a wide temperature range.

[0053] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy, available from Furukawa Techno Material Co., Ltd., Kanagawa Prefecture, Japan. Other suitable materials include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, such as superelastic nitinol, may be used to achieve desired properties.

[0054] In at least some embodiments, the catheter system 10 and / or some or all of its components may be doped with, made from, or include a radiopaque material. A radiopaque material is a material capable of producing a relatively bright image on a fluoroscopy screen or other imaging technique during a medical procedure. This relatively bright image assists the user of the catheter system 10 in determining its location. Some examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, and the like. Other radiopaque marker bands and / or coils may also be incorporated into the design of the catheter system 10 to achieve the same results.

[0055] In some embodiments, the catheter system 10 is provided with a degree of magnetic resonance imaging (MRI) compatibility. For example, the catheter system 10, and / or components or portions thereof, may be made from materials that do not substantially distort images and do not create substantial artifacts (e.g., gaps in the images). For example, certain ferromagnetic materials may not be suitable because they may create artifacts in MRI images. Additionally, the catheter system 10, or portions thereof, may be made from materials that can be imaged by MRI machines. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), nitinol, etc.

[0056] In some embodiments, the exterior surface of the catheter system 10 (including, for example, the exterior surface of the delivery system) may be sandblasted, bead-blasted, sodium bicarbonate-blasted, electropolished, or the like. In these and some other embodiments, a coating, such as a lubricious, hydrophilic, protective, or other type of coating, may be applied over part or all of the outer sheath, or over parts of the delivery system or other portions of the catheter system 10 in embodiments without an outer sheath. Hydrophobic coatings, such as fluoropolymers, provide dry lubricity to improve device handling and exchange. Lubricious coatings improve steerability and lesion crossing capabilities. Suitable lubricious polymers are well known in the art and may include silicones and other hydrophilic polymers, such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxide, polyvinylpyrrolidone, polyvinyl alcohol, hydroxyalkyl cellulose derivatives, algin, sugars, caprolactone, and mixtures and combinations thereof. Hydrophilic polymers can be blended among themselves or with formulated amounts of water-insoluble compounds (including some polymers) to obtain coatings with suitable lubricity, binding, and solubility properties.

[0057] Such coatings and / or sheaths can be formed, for example, by coating, extrusion, coextrusion, interrupted layer coextrusion (ILC), or by fusing several segments end-to-end. The layers can have uniform stiffness or a gradual decrease in stiffness from their proximal to distal ends. The gradual decrease in stiffness can be continuous, such as with ILC, or gradual, such as with fusing separate extruded tubular segments together. The outer layer can be impregnated with a radiopaque filler material to facilitate radiographic visualization. Those skilled in the art will recognize that these materials can vary widely without departing from the scope of this disclosure.

[0058] It should be understood that this disclosure is in many respects merely illustrative. Changes may be made in details, particularly with respect to shape, size, and arrangement of steps, without exceeding the scope of the disclosure. This may include, to the extent appropriate, the use of any of the features of one illustrative embodiment used in another embodiment. The scope of the disclosure is, of course, defined by the language expressed in the appended claims.

Claims

1. 1. A catheter system comprising: a catheter having an elongate shaft extending from a proximal end to a distal end, the elongate shaft defining a catheter lumen extending from the proximal end to the distal end; a hub assembly coupled to the proximal end of the elongate shaft, the hub assembly including a hub assembly lumen in fluid communication with the catheter lumen; a torque assembly releasably coupled to the hub assembly, the torque assembly including a torque assembly lumen in selective fluid communication with the hub assembly lumen; a guidewire coaxially disposed within the catheter lumen, the hub assembly lumen, and the torque assembly lumen; Equipped with The torque assembly is configured to apply torque to the elongate shaft and the guidewire simultaneously in a first configuration and to apply torque to the guidewire independently of the elongate shaft in a second configuration.

2. The catheter system of claim 1 , wherein the length of the guidewire extending distally from the distal end of the elongate shaft is adjustable.

3. The catheter system of claim 1 or 2, wherein the torque assembly is coupled to the hub assembly in the first configuration.

4. The catheter system according to any one of claims 1 to 3, wherein the torque assembly is disengaged from the hub assembly in the second configuration.

5. The catheter system of any one of claims 1 to 4, wherein the torque assembly includes a rotatable valve, a body, a collet, and an actuatable cap.

6. 6. The catheter system of claim 5, wherein the rotatable valve includes a first coupling portion rotatably coupled to a second coupling portion, the second coupling portion configured to rotate independently of the first coupling portion when the first coupling portion is held in a fixed position.

7. 7. The catheter system of claim 6, wherein in the first configuration, the torque assembly is configured to apply a torque to the guidewire independent of the elongate shaft of the catheter when the first coupling portion is held in the fixed position.

8. The catheter system of claim 6 or 7, wherein a distal end region of the body is fixedly attached to the second coupling portion.

9. The catheter system of any one of claims 5 to 8, wherein the collet is configured to be selectively locked to the guidewire.

10. The catheter system of any one of claims 5 to 9, wherein the actuatable cap is actuated to selectively lock the collet onto the guidewire.

11. The catheter system of claim 10 , wherein the actuatable cap is configured to selectively bias a proximal end region of the collet radially inward to lock the collet onto the guidewire.

12. The catheter system of any one of claims 8 to 11, wherein when the guidewire is unlocked from the collet, the guidewire is operable independently of the torque assembly.

13. The catheter system of any one of claims 5 to 12, wherein the body includes an irrigation port in fluid communication with the torque assembly lumen.

14. The catheter system according to any one of claims 5 to 13, wherein the torque assembly further comprises a hemostatic seal.

15. The catheter system of claim 14 , wherein the hemostatic seal is configured to form a fluid-tight seal between the guidewire and the body of the torque assembly.

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