Flexible lockable microcatheter and guidewire coaxial system

Abstract

A catheter system (10) provides adjustability to the length of a guidewire (16) extending distally from a distal tip of a catheter and / or allows the guidewire to be fixed relative to a catheter hub to allow simultaneous steering of the guidewire and the catheter. The catheter system may include a catheter (12) having an elongate shaft (18) defining a catheter lumen; a hub assembly (24) coupled to the proximal end of the elongate shaft and including a hub assembly lumen; a torque assembly (14) releasably coupled to the hub assembly and including a torque assembly cavity; and a guidewire (15) disposed coaxially within the catheter lumen, the hub assembly lumen and the torque assembly lumen. In a first configuration, the torque assembly is configured to apply torque to the elongate shaft and the guidewire simultaneously, and in a second configuration, the torque assembly is configured to apply torque to the guidewire independently of the elongate shaft.

Description

Cross - Reference to Related Applications

[0001] This application claims the benefit of priority of U.S. Provisional Application No. 63 / 410,071, filed on September 26, 2022, the entire content of which is incorporated herein by reference. Field of the Invention

[0002] The present invention generally relates to a torque device and, in particular, a combined torque and rotary hemostatic valve. Background of the Invention

[0003] Microcatheters can be used in selective interventional endovascular procedures to reach target blood vessels for delivering various treatments. The microcatheter can be tracked over a guidewire to reach the target site. Typically, the guidewire can be a steerable device where 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 flushing the microcatheter and immersing it in saline to activate the hydrophilic coating. The microcatheter can then be loaded over the guidewire and inserted into the guide catheter hub. During the procedure, the guidewire can be advanced in concert with the microcatheter. Depending on the clinical need, the length of the guidewire extending distally from the distal end of the microcatheter can be adjusted. The clinician can apply torque to the guidewire to effectively and precisely track the microcatheter to the target site. In some cases, the microcatheter can come with a pre-loaded guidewire as a coaxial system. Generally, there can be two types of pre-assembled systems. Both the first and second pre-assembled systems can have limitations. For example, in the first pre-assembled system, the length of the guidewire extending distally from the distal tip of the microcatheter is limited and cannot exceed a certain predetermined amount. In the second pre-assembled system, the length of the guidewire extending distally from the distal tip of the microcatheter can be adjustable, but the guidewire cannot be locked to the hemostasis hub to allow torque to be applied simultaneously to the microcatheter and the guidewire. There is a current need to provide alternative medical devices and alternative methods for manufacturing and using medical devices. Summary of the Invention

[0004] The present invention provides alternative designs, materials, manufacturing methods, and uses for medical devices.

[0005] In a first example, a catheter system can include a catheter having an elongate shaft extending from a proximal end to a distal end and 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. In a first configuration, the torque assembly can be configured to apply torque simultaneously to the elongate shaft and the guidewire, and in a second configuration, the torque assembly can be configured to apply torque to the guidewire independently of the elongate shaft.

[0006] Alternatively or additionally, for any of the above examples, in another example, the length of the guide wire extending distally from the distal end of the elongate shaft may be adjustable.

[0007] Alternatively or additionally, for any of the above examples, in another example, the torque assembly may be coupled to the hub assembly.

[0008] Alternatively or additionally, for any of the above examples, in another example, in the second configuration, the torque assembly may be separated from the hub assembly.

[0009] Alternatively or additionally, for any of the above examples, in another example, the torque assembly may include a rotatable valve, a body, a chuck, and an actuatable cap.

[0010] Alternatively or additionally, for any of the above examples, in another example, 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 while the first coupling portion remains in a fixed position.

[0011] Alternatively or additionally, for any of the above examples, in another example, when in the first configuration, the torque assembly may be configured to apply torque to the guide wire independent of the catheter shaft while the first coupling portion remains in a fixed position.

[0012] Alternatively or additionally, for any of the above examples, in another example, the distal region of the body may be fixedly secured to the second coupling portion.

[0013] Alternatively or additionally, for any of the above examples, in another example, the chuck may be configured to selectively lock to the guide wire.

[0014] Alternatively or additionally, for any of the above examples, in another example, the actuatable cap may be actuated to selectively lock the chuck to the guide wire.

[0015] Alternatively or additionally, for any of the above examples, in another example, the actuatable cap may be configured to selectively radially inwardly bias a proximal region of the chuck to lock the chuck to the guide wire.

[0016] Alternatively or additionally, for any of the above examples, in another example, when the guide wire is unlocked from the chuck, the guide wire may be actuated independent of the torque assembly.

[0017] Alternatively or additionally, for any of the above examples, in another example, the body may include a flush port in fluid communication with the torque assembly cavity.

[0018] Alternatively or additionally, for any of the above examples, in another example, the torque assembly may further include a hemostatic seal.

[0019] Alternatively or additionally, for any of the above examples, in another example, the hemostatic seal may be configured to form a fluid-impermeable seal between the guidewire and the body of the torque assembly.

[0020] In another example, a catheter system may include a catheter having an elongate shaft extending from a proximal end to a distal end and 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 chuck, and an actuatable cap and 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 fixed relative to the torque assembly. In a first configuration, the torque assembly may be configured to apply torque to both the elongate shaft and the guidewire simultaneously, and in a second configuration, the torque assembly may be configured to apply torque to the guidewire independently of the elongate shaft. The length of the guidewire extending distally from the distal end of the elongate shaft may be adjustable.

[0021] Alternatively or additionally, for any of the above examples, in another example, the torque assembly may further include a hemostatic seal.

[0022] Alternatively or additionally, for any of the above examples, in another example, in a first configuration, the torque assembly may be coupled to the hub assembly, and in a second configuration, the torque assembly may be separated from the hub assembly.

[0023] Alternatively or additionally, for any of the above examples, in another example, 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 while the first coupling portion remains in a fixed position, and when in the first configuration, the torque assembly may be configured to apply torque to the guidewire independently of the catheter shaft while the first coupling portion remains in a fixed position.

[0024] In another example, a catheter system can include a catheter having an elongate shaft extending from a proximal end to a distal end and 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 (which includes a first coupling portion rotatably coupled to a second coupling portion), a body, a chuck, and an actuatable cap and including a torque assembly lumen in selective fluid communication with the hub assembly lumen; and a guide wire coaxially disposed within the catheter lumen, the hub assembly lumen, and the torque assembly lumen and selectively fixed relative to the torque assembly. In a first configuration, the torque assembly can be coupled to the hub assembly and can be configured to apply torque to both the elongate shaft and the guide wire simultaneously, and in a second configuration, the torque assembly can be separated from the hub assembly and can be configured to apply torque to the guide wire independent of the elongate shaft. The length of the guide wire extending distally from the distal end of the elongate shaft can be adjustable. When in the first configuration, the torque assembly can be configured to apply torque to the guide wire independent of the catheter shaft while the first coupling portion remains in a fixed position.

[0025] The foregoing summary of some example embodiments is not intended to describe every disclosed embodiment or every implementation of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The present invention may be more fully understood by considering the following detailed description of various embodiments in conjunction with the accompanying drawings, in which:

[0027] Figure 1 is a perspective view of an illustrative catheter and torque assembly in a first configuration;

[0028] Figure 2 is at Figure 1 a cross-sectional view of the illustrative catheter and torque assembly taken along line 2-2 of

[0029] Figure 3 is Figure 1 a perspective view of the illustrative catheter and torque assembly in a second configuration.

[0030] While the present invention is amenable to various modifications and alternative forms, specific details thereof have been shown by way of example in the drawings and will be described in more detail. It should be understood, however, that the intention is not to limit the various aspects of the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present invention. DETAILED DESCRIPTION

[0031] All numerical values in this document are assumed to be modified by the term "about" whether or not explicitly indicated. The term "about" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the recited number (i.e., having the same function or result). In many instances, the term "about" may indicate a value that includes the value rounded to the nearest significant digit.

[0032] Recitation of a numerical range by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0033] Although some suitable dimensions, ranges, and / or values for various components, features, and / or specifications are disclosed, those skilled in the art to which this invention pertains will understand that desired dimensions, ranges, and / or values can be derived from those expressly disclosed.

[0034] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the context clearly dictates otherwise.

[0035] The following detailed description should be read with reference to the accompanying drawings, in which like elements in different drawings are numbered the same. The detailed description and the drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention. The illustrative embodiments depicted are merely exemplary. Any selected features of any illustrative embodiment may be incorporated into additional embodiments unless expressly stated to the contrary.

[0036] Microcatheters can be used in selective interventional vascular procedures to reach target vessels for delivering various therapies. The microcatheter can be tracked over a guidewire to reach the target site. Typically, the guidewire can be a steerable device, where the clinician uses a torque device to steer the guidewire to the target location. Typical preparation of a microcatheter and guidewire system can include flushing the microcatheter and immersing it in saline to activate the hydrophilic coating. 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 concert with the microcatheter. Depending on clinical needs, the length of the guidewire extending distally from the distal end of the microcatheter can be adjusted. The clinician can apply torque to the guidewire to effectively and precisely track the microcatheter to the target site. In some cases, the microcatheter can come with a pre-loaded guidewire as a coaxial system (e.g., the guidewire extends coaxially within the microcatheter). Typically, there can be two types of pre-assembled systems.

[0037] In a first pre - assembled system, a micro - catheter and a guide - wire hub can be locked together. The system can have a fixed length of the guide - wire extending distally from the distal end of the micro - catheter. The system can allow the guide - wire to be tightly fixed relative to the micro - catheter because a fixed molded hub and / or a torque device at the proximal end of the guide - wire can be locked to the proximal hub of the micro - catheter. However, this may not give the clinician the flexibility to advance or retract the guide - wire in front of the distal tip of the micro - catheter during the procedure according to their comfort and anatomical requirements. For example, the length of the guide - wire extending distally from the distal end of the micro - catheter may not be adjustable. In such a setup, the fixed and / or molded hub at the proximal end of the guide - wire can have a female Luer lock at its proximal end, which allows the clinician to flush the micro - catheter lumen and the guide - wire simultaneously.

[0038] In a second pre - assembled system, a full - length guide - wire can be pre - loaded through the micro - catheter lumen in a manner that allows the guide - wire to be adjustable relative to the micro - catheter and / or is flexible, and without a fixed locking mechanism. This may require a separate auxiliary torque - applying device to effectively rotate the guide - wire. Additionally, in order to flush the micro - catheter before use, a separate hemostatic valve can be attached to the proximal hub of the micro - catheter. This may be necessary because the torque device placed at the proximal end of the guide - wire may not be able to flush the guide - wire or the micro - catheter. The same hemostatic valve can also be used during the procedure to prevent any blood loss and to help the physician lock the sheath of the embolization coil to facilitate the easy transfer of the coil from the sheath to the micro - catheter hub.

[0039] Both the first and second pre - assembled systems described herein may have limitations. For example, in the first pre - assembled system, the length of the guide - wire extending distally from the distal tip of the micro - catheter is limited and cannot exceed a certain predetermined amount. In the second pre - assembled system, the length of the guide - wire extending distally from the distal tip of the micro - catheter can be adjustable, but the guide - wire cannot be locked to the hemostatic hub to allow torque to be applied to both the micro - catheter and the guide - wire simultaneously. The present invention relates to a micro - catheter and guide - wire system that provides adjustability of the length of the guide - wire extending distally from the distal tip of the micro - catheter, and allows the guide - wire to be fixed relative to the micro - catheter hub to allow the guide - wire and the micro - catheter to be turned simultaneously.

[0040] Figure 1 is a perspective view of an illustrative catheter system 10 according to an embodiment of the present invention. The system 10 generally can include a catheter 12, a torque assembly 14, and a guide - wire 16. The catheter 12 can be one of a variety of different catheters. In some cases, the catheter 12 can be an intravascular catheter. Some examples of intravascular catheters include micro - catheters, drug - delivery catheters, diagnostic catheters, and guide catheters. Figure 1 A micro - catheter is shown, but the present invention is not limited thereto. The catheter 12 can be manufactured using conventional techniques.

[0041] The catheter 12 can be sized according to its intended use. For example, the catheter 12 can have a length ranging from about 50 to 200 centimeters and can have a diameter ranging from about 1.7 French (F), although for some applications it can be as large as about 12F.

[0042] In the illustrated embodiment, the catheter 12 can include an elongate shaft 18 having a proximal end 20 and a distal end 22. A hub assembly 24 can be connected to or disposed around the proximal end 20 of the elongate shaft 18. The hub assembly 24 can be fixed to the catheter shaft 18 at the proximal end 20 of the shaft 18 using any suitable technique, such as by an adhesive, friction fit, mechanical fit, chemical bonding, thermal bonding, heat shrink material, molding, casting, welding (e.g., resistance welding or laser welding), soldering, brazing, using a sleeve or polymer layer to bond or connect components, etc. or a combination thereof. In some embodiments, the distal end of the hub assembly 24 can be cast, molded, or shaped onto the proximal end 20 of the shaft 18 such that it is connected to the proximal end 20. In other embodiments, the hub assembly 24 can be formed as a separate component and subsequently attached (e.g., adhered, press fit, etc.) to the proximal end 20 of the catheter shaft 18. In some cases, the hub assembly 24 can include a strain relief 26, although this is not required. When so provided, the strain relief 26 can reduce kinking.

[0043] The guidewire 16 extends from a proximal end 15 to a distal end 17. The guidewire 16 can extend through the lumen of the torque assembly 14, through the lumen 48 of the hub assembly 24, and through the lumen of the elongate shaft 18. The distal end 17 of the guidewire 16 can extend distally beyond the distal end 22 of the elongate shaft 18. The length L by which the guidewire 16 extends distally beyond the distal end 22 of the elongate shaft 18 can be increased or decreased as needed. In some cases, the proximal end 15 of the guidewire 16 can extend proximally from the proximal end of the torque assembly 14, although this is not necessarily required.

[0044] The torque assembly 14 can include a rotary valve 28, a body 30, a movable cap 32, etc. The torque assembly can be configured to receive a guidewire and devices having a diameter up to about 4F. As will be described in more detail herein, the movable cap 32 can 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 can 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 can be axially translated together with the cap 32 in the second configuration to axially translate the guidewire 16 relative to the catheter 12. A side flush port 34 can be provided in the body 30 to flush the catheter 12 and / or the guidewire 16. Although not explicitly shown, the flush port 34 can include plumbing to facilitate attachment of a syringe to the flush port 34. In some embodiments, the flush port 34 can be omitted. In another example, the body 30 can additionally include one or more hemostasis ports. The one or more hemostasis ports can provide options for the clinician.

[0045] Details of the torque assembly 14 are shown in Figure 2 which is a cross-sectional view of an illustrative catheter system 10 taken along line 2-2 of Figure 2 and is in Figure 1 . Generally, the torque assembly 14 can be coupled to the guidewire 16 such that axial and / or rotational movement of the torque assembly 14 is transmitted to the guidewire 16. Additionally, the torque assembly 14 can be selectively coupled to the hub assembly 24 such that axial and / or rotational movement of the torque assembly 14 can be selectively transmitted to the hub assembly 24 and the elongate shaft 18. As will be described in more detail herein, the torque assembly 14 can be coupled to the hub assembly 24 such that rotation of the torque assembly 14 is not necessarily transmitted to the hub assembly 24 and the elongate shaft 18.

[0046] 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 of a thermoplastic polymer. Some illustrative thermoplastic polymers may include, but are not limited to, polyethylene (PE), polypropylene (PP), polymethyl methacrylate (PMMA), polyvinyl chloride (PVC), polyamides, acrylonitrile butadiene styrene (ABS), and polycarbonate. Other materials may be used if desired, such as, but not limited to, other polymers, metals, metal alloys, ceramics, composite materials, etc. The distal portion 42 of the first connector portion 36 may be configured to releasably couple to the proximal region of the hub assembly 24 of the elongate shaft 18. The distal 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 cavity 48 of the hub assembly 24. In some instances, the inner tubular member 46 may be configured to form a friction fit with the cavity 48 of the hub assembly 24. For example, the outer surface of the inner tubular member 46 may be configured to engage the inner surface of the hub assembly 24. It is contemplated that other releasable coupling mechanisms may be used as needed, such as, but not limited to, snap fits, threaded engagement, bayonet-type mechanisms, etc. When the inner tubular member 46 is coupled to the hub assembly 24, rotation of the first connector portion 36 may cause rotation of the hub assembly 24 and the elongate shaft 18.

[0047] The proximal portion 52 of the second connector portion 38 may be configured to couple to the distal region 54 of the body 30. The second connector portion 38 may generally be tubular and may define a cavity extending from its proximal portion 52 to its distal end. The cavity is coupled to the cavity of the inner tubular member 46 of the first connector portion 36 to define a cavity 66 extending from the proximal end of the rotary valve 28 to the distal end of the rotary valve 28. The cavity 66 may be configured to receive the guidewire 16 therethrough. The cavity 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 fixed 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 causes corresponding rotation of the second connector portion 38, and axial movement of the body 30 causes corresponding axial movement of the second connector portion 38. In some instances, the distal tubular extension 56 may be fixed to the first connector portion 36 using any suitable technique, such as, for example, by adhesive, friction fit, mechanical fit, chemical bonding, thermal bonding, heat shrink materials, molding, casting, welding (e.g., resistance welding or laser welding), soldering, brazing, using a jacket or polymer layer to bond or join components, etc. or a combination thereof.

[0048] The coupling portion 40 can generally be an annular loop that is configured to movably couple the first and second connector portions 36, 38. The proximal region 50 of the first connector portion 36 can be rotatably coupled to the distal end of the coupling portion 40 and / or the second connector portion 38, while the inner surface 58 of the coupling portion 40 can be fixedly secured to the second connector portion 38. The second connector portion 38 and the coupling portion 40 can be coupled such that the second connector portion 38 moves with the coupling portion 40, and vice versa. In some instances, the first connector portion 36 can be configured to rotate with the coupling portion 40 and / or the second connector portion 38, while in other instances, the first connector portion 36 can be configured to remain stationary while rotating the coupling portion 40 and / or the second connector portion 38. For example, a clinician can hold the first connector portion 36 to maintain the first connector portion 36 in a stationary position while rotating the coupling portion 40 and / or the second connector portion 38. When the first connector portion 36 remains stationary, rotation of the torque assembly 14 is not transmitted to the hub assembly 24 and the elongate shaft 18. This can allow 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 can be positioned 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 to allow torque to be applied to both the guidewire 16 and the elongate shaft 18 simultaneously.

[0049] The body 30 may extend proximally from the distal region 54 to the proximal region 62. The body 30 may be formed of a thermoplastic polymer. Some illustrative thermoplastic polymers may include, but are not limited to, polyethylene (PE), polypropylene (PP), polymethyl methacrylate (PMMA), polyvinyl chloride (PVC), polyamides, acrylonitrile butadiene styrene (ABS), and polycarbonate. Other materials may be used as needed, such as, but not limited to, other polymers, metals, metal alloys, ceramics, composite materials, etc. The lumen 64 may extend from the proximal end to the distal end of the body 30. The 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 to the proximal region 62 of the body 30 and a second, smaller diameter adjacent to the distal region 54 of the housing. A transition region 94 may extend between the first and second diameters. The lumen 64 may be configured to receive the guidewire 16 therethrough. The flush port 34 may be in fluid communication with the lumen 64 or the lumen 66 to allow flushing of the guidewire 16 and / or the elongate shaft 18 prior to use or for introducing a therapeutic agent or device. The outer surface of the body 30 may be textured or otherwise include features for increasing the grippability of the body 30. In some examples, the textured outer surface may include a plurality of ridges 68 and a plurality of recesses 70. The recesses 70 may extend through less than the entire thickness of the body 30, or may extend through less than half of the thickness of the body 30. It is also contemplated that the textured surface may extend along less than the entire length of the body 30. The outer surface of the proximal region 62 of the body 30 may include a plurality of threads 72. The plurality of external threads 72 may be configured to threadedly engage mating internal threads 74 on the cap 32.

[0050] The chuck 76 may be disposed at least partially within the lumen 64 of the body 30 adjacent to the proximal region 62 of the body 30. The chuck 76 may be formed of a thermoplastic polymer or metal. Some illustrative thermoplastic polymers may include, but are not limited to, polyethylene (PE), polypropylene (PP), polymethyl methacrylate (PMMA), polyvinyl chloride (PVC), polyamides, acrylonitrile butadiene styrene (ABS), and polycarbonate. Other materials may be used as needed, such as, but not limited to, other polymers, metals, metal alloys, ceramics, composite materials, etc. In some cases, the chuck 76 may be fixedly secured to the body 30. The chuck 76 may be secured to the body 30 by any suitable technique, e.g., by an adhesive, friction fit, mechanical fit, chemical bonding, thermal bonding, heat shrink materials, molding, casting, welding (e.g., resistance welding or laser welding), soldering, brazing, using a jacket or polymer layer to bond or join components, etc. or a combination thereof. In some cases, the chuck 76 and the body 30 may include a mechanical interlock, such as, but not limited to, a pair of mating raised ridges 83a, 83b to prevent the chuck 76 from disengaging from the body 30.

[0051] The chuck 76 may define a lumen 78 extending from its proximal end to its distal end. The lumen 78 may communicate with the lumen 64 of the body 30. The proximal region 80 of the chuck 76 may be configured to selectively engage or clamp the outer surface of the guidewire 16 to secure the guidewire 16 to the torque assembly 14 such that movement of the torque assembly 14 is transmitted to the guidewire 16. For example, the proximal region 80 may include a pair of deflectable arms 81a, 81b (collectively 81) configured to deflect radially inwardly to clamp the guidewire 16. For example, as will be described in more detail herein, the cap 32 may be actuated to deflect the arms 81 to clamp the guidewire 16. A hemostatic seal 92 may be positioned between the distal end of the chuck 76 and the 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 flowing out of the proximal end of the torque assembly 14. The hemostatic seal 92 may be formed of a flexible rubber, silicone, elastomer, etc. such that the hemostatic seal 92 may form a fluid-impermeable seal between the guidewire 16 and the body 30.

[0052] The cap 32 may be disposed over the proximal region 62 of the body 30 and the proximal region 80 of the chuck 76. The cap 32 may define a lumen 82 extending from the proximal end 84 to the 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 greater than the first diameter. The lumen 82 may include a tapered transition region 88 positioned 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, the gradual transition may have a slope or angle generally mating with the tapered outer surface 90 of the proximal end of the chuck 76 to facilitate axial movement of the cap 32 relative to the chuck 76. In a radially unbiased configuration, the arms 81 of the chuck 76 may have an outer diameter greater than the first diameter of the lumen 82 of the cap 32 and greater than the outer diameter of the proximal portion of the transition region 88.

[0053] As described herein, the cap 32 can include a plurality of internal threads 74 configured to threadedly engage the external threads 72 of the body 30. It is contemplated that rotation of the cap 32 relative to the body 30 can axially move the cap 32 along the longitudinal axis of the torque assembly 14. Rotation of the cap 32 in a first direction can move the cap 32 distally relative to the body 30. This can cause the inner surface of the transition region 88 and / or the region of the lumen 78 having a first diameter to contact the outer surface 90 of the proximal end of the chuck 76. Further distal movement of the cap 32 can cause the transition region 88 to bias the arms 81 inwardly to clamp the guidewire 16. When the chuck 76 is locked to the guidewire 16, actuation of the body 30 and / or the cap 32 is transmitted to the guidewire 16. Rotation of the cap 32 in a second direction opposite the first direction can move the cap 32 proximally relative to the body 30. This can allow the arms 81 of the proximal region 80 to expand and release the guidewire 16. When the guidewire 16 is released from the chuck 76, the guidewire 16 can be axially displaced along the longitudinal axis of the torque assembly 14 in a proximal and / or distal direction independent of the torque assembly 14 and / or the elongate shaft 18. If a clinician desires to adjust the length L of the guidewire 16 extending distally from the distal end of the elongate shaft 18, the cap 32 can be actuated to release the biasing force of the arms 81 of the chuck 76. The guidewire 16 can then be retracted proximally or advanced distally as needed. When 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 chuck 76 radially inwardly to clamp the guidewire 16 and secure the guidewire 16 to the torque assembly 14.

[0054] In use, torque can be applied to the guidewire 16 and the elongate shaft 18 together or separately. To apply torque to 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 the cap 32 locked to the guidewire 16, as Figure 1 shown. For example, the rotary valve 28 can be coupled to the hub assembly 24. Additionally, the cap 32 can be actuated (e.g., advanced distally) by deflecting the arms 81 of the chuck 76 radially inwardly to lock the torque assembly 14 to the guidewire 16. In the case where the torque assembly 14 is locked to both the guidewire 16 and the elongate shaft 18, both the guidewire 16 and the elongate shaft 18 will move together. For example, the guidewire 16 and the elongate shaft 18 can be retracted proximally, advanced distally, and / or twisted together.

[0055] In some cases, it may be desirable to apply torque to the guidewire 16 separately from the elongate shaft 18 (or vice versa). In one example, the torque assembly 14 can be locked to the hub assembly 24 of the elongate shaft 18 and the cap 32 locked to the guidewire 16. The clinician can hold the first connector portion 36 of the rotary valve 28 to prevent rotation of the first connector portion 36 and thus prevent rotation of the hub assembly 24 and the elongate shaft 18. The body 30 can then be rotated to apply torque to the guidewire 16. For example, as described above, the second connector portion 38 can be coupled to the body 30 such that movement of the body 30 is transmitted to the second connector portion 38. When the clinician holds the first connector portion 36, rotation of the body 30 can cause the second connector portion 38 to rotate while the first connector portion 36, the hub assembly 24, and the elongate shaft 18 remain stationary.

[0056] In another example, the torque assembly 14 can be unlocked from the hub assembly 24, as Figure 3 shown, Figure 3 FIG. shows a perspective view of the catheter system 10, where the torque assembly 14 is unlocked from the hub assembly 24. When the chuck 76 is locked to the guidewire 16 and the torque assembly 14 is unlocked from the hub assembly 24, the torque assembly 14 can be rotated and / or axially displaced to apply torque to the guidewire 16 or axially displace it without simultaneously moving the elongate shaft 18. In some cases, the torque assembly 14 can be unlocked from the hub assembly 24 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 reduce 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 that extends distally beyond the distal end 22 of the elongate shaft 18 can be further adjusted by releasing the chuck 76, moving the guidewire 18, and re-locking the chuck 76 to the guidewire 18.

[0057] The materials for the various components and their various elements of the medical devices and / or systems (and / or other systems disclosed herein) that can be used herein can include those commonly associated with medical devices. For simplicity, the following discussion refers to the catheter system 10. However, this is not intended to limit the devices and methods described herein, as the discussion can apply to other elements, components, parts, or devices disclosed herein, such as, but not limited to, the elongate shaft 18 and the torque assembly 14 and / or their elements or parts.

[0058] In some embodiments, the catheter system 10 and / or its components can be made of metal, metal alloy, polymer (some examples of which are disclosed below), metal-polymer composite, ceramic, combinations thereof, etc. or other suitable materials.

[0059] Some examples of suitable polymers can include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., commercially available from DuPont as ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., commercially available from DSM Engineering Plastics as ), ether or ester-based copolymers (e.g., butylene phthalate / poly(alkylene ether) and / or other polyester elastomers, such as commercially available from DuPont as ), polyamides (e.g., commercially available from Bayer as or commercially available from Elf Atochem as ), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, e.g., commercially available under the trade name ), ethylene-vinyl acetate copolymer (EVA), silicone, polyethylene (PE), high density polyethylene, low density polyethylene, linear low density polyethylene (e.g., ), polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., ), polysulfone, nylon, nylon-12 (such as commercially available from EMS American Grilon as ), perfluoro(propyl vinyl ether) (PFA), ethylene-vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers, polymer / metal composites, etc.

[0060] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels; low carbon steels; 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 625, UNS:N06022, such as UNS:N10276, such as others alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as etc.), nickel-molybdenum alloys (e.g., UNS: N10665, such as ALLOY ), 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, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.); platinum-rich stainless steels; titanium; combinations thereof; etc.; or any other suitable material.

[0061] As mentioned herein, within the commercially available family of nickel-titanium or nitinol alloys, there is a class designated as "linear elastic" or "non-superelastic" that, although chemically similar to conventional shape memory and superelastic varieties, can exhibit different and useful mechanical properties. Linear elastic and / or non-superelastic nitinol can be distinguished from superelastic nitinol in that linear elastic and / or non-superelastic nitinol does not display a significant "superelastic plateau" or "flag region" in its stress / strain curve as does superelastic nitinol. Instead, in linear elastic and / or non-superelastic nitinol, as the recoverable strain increases, the stress continues to increase in a generally linear or somewhat but not necessarily completely linear relationship until plastic deformation begins or at least in a more linear relationship than the superelastic plateau and / or flag region that might be seen in superelastic nitinol. Thus, for the purposes of this invention, linear elastic and / or non-superelastic nitinol can also be referred to as "substantially" linear elastic and / or non-superelastic nitinol.

[0062] In some cases, linear elastic and / or non-superelastic nitinol can also be distinguished from superelastic nitinol in that linear elastic and / or non-superelastic nitinol can accept up to about 2 - 5% strain while remaining substantially elastic (e.g., prior to plastic deformation), while superelastic nitinol can accept up to about 8% strain prior to plastic deformation. Both of these materials can be distinguished from other linear elastic materials, such as stainless steel (which can also be distinguished based on its composition), which can accept only about 0.2 to 0.44% strain prior to plastic deformation.

[0063] In some embodiments, linear elastic and / or non-superelastic nitinol is an alloy that does not exhibit any martensitic / austenitic phase transitions detectable by differential scanning calorimetry (DSC) and dynamic mechanical thermal analysis (DMTA) over a large temperature range. For example, in some embodiments, in linear elastic and / or non-superelastic nickel-titanium alloys, there may be no martensitic / austenitic phase transitions detectable by DSC and DMTA analysis in the range of about -60 degrees Celsius (°C) to about 120 °C. Thus, the mechanical bending properties of such materials are generally inert to temperature effects over this very wide temperature range. In some embodiments, the mechanical bending properties of linear elastic and / or non-superelastic nickel-titanium alloys at ambient temperature or room temperature are substantially the same as their mechanical properties at, for example, body temperature, because they do not exhibit a superelastic plateau and / or a flag region. In other words, over a wide temperature range, linear elastic and / or non-superelastic nickel-titanium alloys maintain their linear elastic and / or non-superelastic characteristics and / or properties.

[0064] In some embodiments, linear elastic and / or non-superelastic nickel-titanium alloys can be in the range of about 50 to about 60 weight percent nickel, with the balance being primarily titanium. In some embodiments, the composition contains nickel in the range of about 54 to about 57 weight percent. An example of a suitable nickel-titanium alloy is the FHP-NT alloy commercially available from Furukawa TechnoMaterial Co., Kanagawa, Japan. Other suitable materials include ULTANIUM TM (available from Neo-Metrics) and GUMMETAL TM (available from Toyota). In some other embodiments, superelastic alloys, such as superelastic nitinol, can be used to achieve the desired properties.

[0065] In at least some embodiments, part or all of the catheter system 10 and / or its components can also be doped with, made of, or otherwise include a radiopaque material. A radiopaque material should be understood as a material that can produce a relatively bright image on a fluoroscope or with another imaging technique during a medical procedure. Such a relatively bright image helps a user of the catheter system 10 to determine its position. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, etc. Additionally, other radiopaque marker bands and / or coils can also be incorporated into the design of the catheter system 10 to achieve the same result.

[0066] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the catheter system 10. For example, the catheter system 10 and / or its components or parts can be made of materials that substantially do not distort the image and create a large number of artifacts (e.g., gaps in the image). For example, certain ferromagnetic materials may not be suitable because they may create artifacts in the MRI image. The catheter system 10 or parts thereof can also be made of materials that can be imaged by an MRI machine. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloy (e.g., UNS: R30003, such as etc.), nickel-cobalt-chromium-molybdenum alloy (e.g., UNS: R30035, such as etc.), nitinol, etc.

[0067] In some embodiments, the outer surface of the catheter system 10 (including, for example, the outer surface of the delivery system) can be sandblasted, bead blasted, soda blasted, electropolished, etc. In these and some other embodiments, a coating, such as a lubricious, hydrophilic, protective, or other type of coating, can be applied over part or all of the outer sheath, or in some embodiments, there is no outer sheath over part of the delivery system or other parts of the catheter system 10. Hydrophobic coatings, such as fluoropolymers, provide dry lubricity, which improves the handling of the device and the exchange of the device. Lubricious coatings improve steerability and improve lesion crossing ability. Suitable lubricious polymers are well known in the art and can include silicone, etc., hydrophilic polymers, such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinylpyrrolidone, polyvinyl alcohol, hydroxyalkyl cellulose, algae, sugars, caprolactone, etc., and mixtures and combinations thereof. Hydrophilic polymers can be mixed with each other or with a formulation amount of water-insoluble compounds (including some polymers) to produce a coating with appropriate lubricity, adhesiveness, and solubility.

[0068] The coating and / or sheath can be formed, for example, by coating, extrusion, coextrusion, interrupted layer coextrusion (ILC), or fusing together several segments end-to-end. The layer can have a uniform stiffness or a stiffness that gradually decreases from its proximal end to its distal end. The gradual decrease in stiffness can be continuous, as formed by ILC, or can be stepped, as formed by fusing together separate extruded tubular segments. 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 the invention.

[0069] It should be understood that the present invention is illustrative in many aspects. Changes may be made in details, particularly in matters of the shape, size and arrangement of steps, without exceeding the scope of the present invention. To an appropriate extent, this may include using any one of the features of an exemplary embodiment used in other embodiments. Of course, the scope of the present invention is defined by the language expressing the appended claims.

Claims

1. A catheter system, comprising: a catheter having an elongate shaft extending from a proximal end to a distal end and 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 selectively in fluid communication with the hub assembly lumen; and a guide wire coaxially disposed within the catheter lumen, the hub assembly lumen, and the torque assembly lumen; wherein, in a first configuration, the torque assembly is configured to apply torque to both the elongate shaft and the guide wire, and in a second configuration, the torque assembly is configured to apply torque to the guide wire independent of the elongate shaft.

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

3. The catheter system according to any one of claims 1 to 2, wherein in the first configuration, the torque assembly is coupled to the hub assembly.

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

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

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

7. The catheter system according to claim 6, wherein when in the first configuration, the torque assembly is configured to apply torque to the guide wire independent of the catheter shaft while the first coupling portion remains in the fixed position.

8. The catheter system according to any one of claims 6 to 7, wherein a distal region of the body is securely fixed to the second coupling portion.

9. The catheter system according to any one of claims 5 to 8, wherein the chuck is configured to selectively lock to the guide wire.

10. The catheter system according to any one of claims 5 to 9, wherein actuating the actuatable cap selectively locks the chuck to the guide wire.

11. The catheter system according to claim 10, wherein the actuatable cap is configured to selectively radially inwardly bias a proximal region of the chuck to lock the chuck to the guide wire.

12. The catheter system according to any one of claims 8 to 11, wherein when the guide wire is unlocked from the chuck, the guide wire is actuatable independent of the torque assembly.

13. The catheter system according to any one of claims 5 to 12, wherein the body includes a flush 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 includes a hemostatic seal.

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

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