Catheter handle with torque mechanism and valve pressure relief assembly

Abstract

A catheter (100) includes a handle (112) having a torque (116) and steering (144) mechanism. The torque mechanism includes a rotatable nose cone (118) and a bearing (126) coupled to the nose cone so as to rotate therewith. The bearing is concentrically disposed on a shaft (102) of the catheter and is configured to transfer torque from the nose cone to the shaft when the nose cone rotates. The steering mechanism includes a rack (134) coupled to the bearing so as to slide therewith, and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nose cone causes the entire length of the shaft to rotate, and axial movement of the rack tensions the pull wire (16) to bend the distal portion of the shaft.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 62 / 865,437, filed on June 24, 2019, which is hereby incorporated by reference in its entirety for all purposes. Technical Field

[0003] Embodiments of the present invention relate to catheters, and more particularly to handles for catheters or delivery systems. Background Art

[0004] There have been various catheters for delivering treatment and / or monitoring physiological conditions that have been implanted or suggested to be implanted in the patient's body. The catheter can deliver treatment and / or monitor the condition associated with them to the heart, muscle, nerve, brain, stomach or other organs or tissues. Many catheters are tracked through the vascular system so that the treatment or diagnosis part of the catheter is positioned at the target site. Such catheters must have flexibility to advance in the tortuosity of the vascular system, must have enough hardness in its proximal portion to be pushed through the vascular system either individually or on a guide wire or by a cavity, and will have the ability to direct its distal portion to align with the anatomical features at the target site, so that diagnosis or treatment procedures can be completed. Generally speaking, the catheter body must also be kink-resistant and can be advanced through the tortuosity, the access path that sometimes suddenly appears sharp angle turns.

[0005] For some operations, the clinician may need to accurately turn or deflect the catheter so that its distal opening can be aligned with the mouth of a branch vessel or a side vessel. The distal portion of the catheter often needs to be selectively bent and straightened again, while advancing in the patient's body to turn the catheter distal end to the desired body cavity or chamber. For example, it may be necessary to guide the catheter distal end through a tortuous anatomical structure and / or enter the branch at the bifurcation of the blood vessel. In addition, some operations require the high accuracy of guidewire orientation. For example, the patient's artery is often irregular in shape, highly tortuous and very narrow. The tortuous structure of the artery may bring difficulties when the clinician advances the catheter to the treatment site.

[0006] In addition to bending or deflecting the distal portion of the catheter during advancement, the clinician may also need to turn or torque the catheter when advancing the catheter to the treatment site to achieve proper or desired alignment of the catheter. Currently, the clinician holds and turns the entire handle of the catheter to manually torque the catheter. However, manually torqueing the entire device causes unstable movement of the catheter while it is in the patient's body and may require considerable force to counter the recoil force. In addition, when the handle of the catheter is turned during the torque process, the control devices on the handle may be placed in a position that limits the ability to use them.

[0007]

[0006] Thus, there remains a general need in the art for improved devices and methods for navigating a catheter through or within a patient's anatomy. Summary of the invention

[0008] Embodiments of the present invention are directed to a catheter comprising a handle and a shaft extending from the handle, wherein the handle comprises a housing and a torque mechanism disposed at least partially within the housing of the handle. The torque mechanism comprises a nose cone that can rotate relative to the housing of the handle and a bearing coupled to the nose cone so as to rotate therewith. The bearing is concentrically disposed on the shaft and is configured to transfer torque from the nose cone to the shaft when the nose cone rotates, such that rotation of the nose cone causes the entire length of the shaft to rotate therewith.

[0009] Embodiments of the present invention also relate to a catheter comprising a handle and a shaft extending from the handle, wherein the handle comprises a housing, a torque mechanism at least partially disposed within the housing interior of the handle, and a steering mechanism at least partially disposed within the housing interior of the handle. The torque mechanism comprises a nose cone that can rotate relative to the housing of the handle and a bearing coupled to the nose cone so as to rotate therewith. The bearing is concentrically disposed on the shaft and is configured to transfer torque from the nose cone to the shaft when the nose cone rotates. The steering mechanism comprises a rack and a pull wire having a proximal end attached to the bearing and a distal end attached to the distal portion of the shaft. The rack is coupled to the bearing so that the bearing can slide therewith. The rotation of the nose cone causes the entire length of the shaft to rotate therewith, and the bearing rotates relative to the rack during its rotation, and the axial movement of the rack tensions the pull wire to bend the distal portion of the shaft, and the bearing slides relative to the shaft and relative to the nose cone during its axial movement.

[0010] Embodiments of the present invention also relate to a catheter comprising a handle and a shaft extending from the handle, wherein the handle comprises a housing, a nose cone that can rotate relative to the housing of the handle, a bearing that is concentrically disposed on the shaft and configured to transmit torque to the shaft when the bearing rotates, a rack, and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. The bearing is coupled to the nose cone so that it can rotate therewith, and the rack is coupled to the bearing so that the bearing can slide therewith. Rotation of the nose cone causes the entire length of the shaft to rotate therewith, and the bearing rotates relative to the rack during its rotation, and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft, and the bearing slides relative to the shaft and relative to the nose cone during its axial movement.

[0011] Embodiments of the present invention also relate to a catheter, comprising a handle, a shaft extending distally from the handle, a strain relief assembly concentrically disposed on a portion of the shaft and extending distally from the handle, a balloon-expandable prosthesis disposed on the distal portion of the shaft, and a valve pressure relief assembly slidably disposed on an outer surface of the shaft. The valve pressure relief assembly is configured to be selectively disposed on the balloon-expandable prosthesis to protect the balloon-expandable prosthesis during insertion of the guide sheath. When the strain relief assembly is not disposed on the balloon-expandable prosthesis, the strain relief assembly is configured to serve as a docking station for the valve pressure relief assembly. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The foregoing and other features and advantages of the present invention will become apparent from the following description of the embodiments of the present invention as shown in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of this specification, are further used to explain the principles of the present invention and enable those skilled in the relevant art to make and use the present invention. The accompanying drawings are not drawn to scale.

[0013] Figure 1 is a side view of a catheter or delivery system according to an embodiment of the present invention, wherein the catheter includes a handle including a torque mechanism and a steering mechanism, and wherein the catheter includes a balloon-expandable prosthesis disposed at a distal portion thereof.

[0014] Figure 2 yes Figure 1 A side view of a distal portion of a catheter, wherein the distal portion is bent in a first direction via a steering mechanism of a handle of the catheter.

[0015] Figure 3 yes Figure 1 A side view of a distal portion of a catheter, wherein the distal portion is bent in a second or opposite direction via a steering mechanism of a handle of the catheter.

[0016] Figure 4 yes Figure 1 A perspective view of a handle of a catheter of FIG. 1 with the outer shell or housing of the handle removed for illustration purposes.

[0017] Figure 5 yes Figure 1 An exploded perspective view of the handle of a catheter.

[0018] Figure 6 yes Figure 1 A side view of the distal portion of the handle of a catheter of FIG. 1 , showing a portion of the housing of the handle, the nose cone, and the locking mechanism, with the remaining components removed for illustration purposes.

[0019] Figure 7 yes Figure 1A perspective view of a slide of a locking mechanism of a handle of a catheter of FIG. Wherein, for the purpose of illustration, the slide is removed from the handle.

[0020] Fig. 8A yes Figure 1 A perspective view of a portion of a shaft of a catheter and a strain relief segment disposed on the shaft, wherein the shaft and the strain relief segment are removed from the catheter for illustration purposes.

[0021] Figure 8B yes Figure 1 Another perspective view of a portion of a shaft of a catheter and a strain relief segment disposed on the shaft, wherein the shaft and the strain relief segment are removed from the catheter for illustration purposes.

[0022] Fig.9A yes Figure 1 A perspective view of a portion of a nose cone of a handle of a catheter of FIG. 1 , wherein the nose cone is removed from the handle for illustration purposes.

[0023] Fig. 9B yes Figure 1 A perspective view of a distal portion of a nose cone of a handle of a catheter of FIG. 1 , wherein the nose cone is removed from the handle for illustration purposes.

[0024] Fig.10 yes Figure 1 A perspective view of a bearing of a handle of a catheter of FIG. 1 , wherein the bearing is removed from the handle for illustration purposes.

[0025] Fig. 10A yes Figure 1 Side view of a bearing of a handle of a catheter with the bearing removed from the handle for illustration purposes.

[0026] Fig. 10B yes Figure 1 Front view of a bearing of a handle of a catheter with the bearing removed from the handle for illustration purposes.

[0027] Fig.11 yes Figure 1 A perspective view of the nose cone and bearing assembly of the handle of a catheter of FIG. 1 , wherein the assembly is removed from the handle for illustration purposes.

[0028] Fig.12 yes Figure 1 A perspective view of a rack of a handle of a catheter with the rack removed from the handle for illustration purposes.

[0029] Fig.13 yes Figure 1 A perspective view of a knob of a handle of a catheter with the knob removed from the handle for illustration purposes.

[0030] Fig.14 yes Figure 1 A perspective view of a rack and knob assembly of a handle of a catheter of FIG. 1 , wherein the assembly is removed from the handle for illustration purposes.

[0031] Fig.15 yes Figure 1 A side view of a rack and bearing assembly of a handle of a catheter of FIG. 1 , wherein the assembly is removed from the handle for illustration purposes.

[0032] Fig.16 yes Figure 1 A perspective view of a housing or casing of a handle of a catheter with the housing removed from the handle for illustration purposes.

[0033] Fig.17 yes Figure 1 A side cross-sectional view of a handle of a catheter with a portion of the housing and nose cone removed for illustration purposes.

[0034] Fig.18 yes Figure 1 A perspective view of a catheter of wherein the housing of the handle is removed for illustrative purposes and the pull wire of the steering mechanism is shown in phantom within the catheter.

[0035] Fig.19 yes Fig.18 An enlarged view of a portion of the handle depicting the pull wire exiting the shaft and being attached to a bearing within the handle.

[0036] Fig. 20 It is possible to Figure 1 Side view of a valve pressure reducing assembly for use with a catheter.

[0037] Fig.21 is slidably mounted on Figure 1 on the shaft of the catheter Fig. 20 Side view of a valve pressure reducing assembly.

[0038] Fig. 22 yes Figure 1 A side view of the distal portion of the catheter, wherein Fig. 20 The valve pressure relief assembly is placed on the balloon-expandable prosthesis.

[0039] Fig.23 yes Figure 1 A side view of a distal portion of a catheter, wherein the catheter is inserted through an introducer sheath, wherein Fig. 20 The valve pressure relief assembly is placed on the balloon-expandable prosthesis.

[0040] Fig.24 yes Fig.21 A side view of a catheter, wherein Fig. 20The valve pressure relief assembly is docked to the strain relief assembly of the handle of the catheter.

[0041] Fig.25A It is possible to Figure 1 A side view of another configuration of a valve pressure reducing assembly for use with a catheter.

[0042] Fig.25B yes Figure 1 25 is disposed on a balloon-expandable prosthesis.

[0043] Fig.25C yes Fig.21 25 is docked to the strain relief assembly of the handle of the catheter.

[0044] Fig.26 yes Figure 1 A perspective view of a strain relief assembly of a handle of a catheter of FIG. 1 , wherein the strain relief assembly is removed from the catheter for illustration purposes.

[0045] Fig. 27 is a perspective view of another configuration of a strain relief assembly that may be used in embodiments of the present invention.

[0046] Fig.28 is a perspective view of another configuration of a strain relief assembly that may be used in embodiments of the present invention.

[0047] Fig.29 is a perspective view of another configuration of a strain relief assembly that may be used in embodiments of the present invention.

[0048] Fig.30 is a perspective view of a magnetic coupling that may be used in embodiments of the present invention. DETAILED DESCRIPTION

[0049] Specific embodiments of the present invention are now described with reference to the accompanying drawings, wherein the same reference numerals indicate the same or functionally similar elements. In the following description, the terms "distal" and "proximal" are used with respect to a position or direction relative to a treating clinician. "Distal" or "distally" is a position away from the clinician or in a direction away from the clinician. "Proximal" and "proximally" are positions close to the clinician or in a direction toward the clinician. In addition, "slidably" or "slidable" refers to a position around the longitudinal axis L of the handle. A (like Figure 1 "rotatable" or "rotatable" means movement around the longitudinal axis of the handle. LA movement or rotation.

[0050] The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and use of the invention. Although the invention is described in the context of delivering a balloon-expandable prosthesis, the invention may also be used where it is considered useful in endoscopic surgery, coronary vascular surgery, or peripheral vascular surgery. In addition, it is not intended to be bound by any expressed or implied theory present in the above technical field, background technology, invention summary or the following detailed description.

[0051] Embodiments of the present invention relate to a handle for delivering a catheter or other catheter device, the handle including a torque mechanism. The torque mechanism includes a nose cone that can rotate relative to the housing of the handle and a bearing that is connected to the nose cone so that it can rotate with it. The bearing is concentrically arranged on the shaft of the catheter and is configured to transfer torque from the nose cone to the shaft when the nose cone rotates. The rotation of the nose cone causes the entire length of the shaft to rotate with it. Therefore, the handle has the ability to circumferentially torque the entire length of the shaft to a precise angle with an actuator (i.e., a rotatable nose cone), thereby allowing the stability of the handle to be increased during use. In other words, the handle itself does not need to be twisted or rotated to guide the distal end of the shaft, and therefore other control devices or actuators on the handle remain stationary during surgery and are easy to use by the user. The handle also includes a steering mechanism to apply tension on the pull line to bend the distal portion of the shaft, and both the torque mechanism and the steering mechanism are integrated into the handle so that the operation of the torque mechanism does not interfere with the operation of the steering mechanism. In addition, the catheter further includes a valve decompression assembly, which is also used to release the strain of the distal portion of the catheter when the catheter is inserted through the guide sheath. The valve pressure relief assembly can be fixed to the handle after being inserted through the introducer sheath to ensure that it does not slip on the catheter during the procedure.

[0052] The catheter will now be described in more detail with reference to the accompanying drawings. Figure 1 , the catheter 100 includes a handle 112 and a shaft 102 having a distal end 106 opposite the handle 112. As will be described in more detail herein, the handle 112 includes both a torque mechanism 116 and a steering mechanism 144. The shaft 102 defines a central lumen 110 so that the catheter 100 can be slidably positioned and tracked over a guidewire (not shown). The shaft 102 may further define additional lumens depending on the particular configuration of the catheter 100. The balloon-expandable prosthesis 101 is mounted on a balloon 105, which is positioned on a distal portion of the shaft 102. The balloon-expandable prosthesis 101 is Figure 1105 is shown in its delivery or unexpanded configuration, but it will be understood by those of ordinary skill in the art that after deployment, the balloon-expandable prosthesis 101 is radially expanded or expanded by the balloon 105 and released from the catheter 100 at a desired position in the patient's body cavity. The configuration of the balloon-expandable prosthesis 101 is merely exemplary, and it is obvious to those of ordinary skill in the art that the catheter 100 can be used to deliver and deploy prostheses of various types or configurations. Further, although depicted as a delivery catheter for a balloon-expandable prosthesis 101, the catheter 100 does not need to be configured to deliver the prosthesis, but rather, the catheter 100 with the handle 112 can be used for other procedures or for other purposes, including diagnostic purposes. The handle 112 with both the torque mechanism 116 and the steering mechanism 144 is advantageous in any type of catheter that may require torque and / or steering during in-situ travel. Although the catheter 100 described herein is a stand-alone delivery catheter for delivering a balloon-expandable prosthesis 101, in another embodiment (not shown) herein, the catheter 100 forms an external component of another type of treatment or delivery system.

[0053] The torque mechanism 116 allows the distal portion of the catheter 100 to be rotated as indicated by directional arrow 117 by rotating a nose cone 118 disposed at the distal end of the handle 112 while holding the proximal end of the handle 112, which contains the remaining controls. The steering mechanism 144 includes a pull wire 146 (at Fig.18 and 19 100 is a slit in the catheter 100 that is attached to the distal end 106 of the shaft 102 to be selectively tensioned to bend the distal end 106 of the catheter. The pull wire 146 is configured to rotate to the same angle as the shaft 102 when the catheter 100 is torqued via the rotation of the nose cone 118. When the pull wire 146 is retracted via the steering mechanism 144, the pull wire 16 is placed under tension to bend or deflect the distal portion of the catheter 100. For example, Figure 2 1 is a side view of the distal portion of the catheter 100, which depicts the distal portion of the catheter 100 bent in a first direction via the steering mechanism 144, as shown by the directional arrow 145A. Figure 3 To bend or deflect the distal portion of the catheter 100 (as shown by the directional arrow 145B in FIG), the torque mechanism 116 can be actuated to rotate the catheter approximately 180 degrees, and then the steering mechanism 144 can be actuated to bend the distal portion of the catheter 100.

[0054] The handle 112 includes a housing or casing 114 that houses the internal components of the handle 112. Figure 4 and Figure 5 The components of the handle 112 are introduced, wherein Figure 4 is a perspective view of the handle 112 with its housing 114 removed for illustration purposes, and Figure 5 1 is an exploded perspective view of the handle 112. In addition to the housing 114, the handle 112 also includes a nose cone 118 that can rotate relative to the housing 114, a bearing 126 disposed in the housing 114 and concentrically disposed on the shaft 102, a rack 134 coupled to the bearing 126, a pull wire 146 (at Fig.18 and Fig.19 ), a locking mechanism 158, a strain relief assembly 170 disposed on a portion of the shaft 102 at the distal end of the housing 114, and a luer connector 178 disposed on a portion of the shaft 102 at the proximal end of the housing 114. The luer connector 178 is attached to the housing 114, and the shaft 102 is disposed through the luer connector 178 such that the shaft 102 is configured to freely rotate or rotate within the luer connector 178 and can therefore rotate relative to the housing 114.

[0055] See also Figure 6 and Figure 7 , the locking mechanism 158 is configured to lock the circumferential position of the nose cone 118 relative to the housing 114 of the handle 122 . Figure 6 is a side view of a distal portion of the handle 112 showing a portion of the housing 114 , the nose cone 118 , and the locking mechanism 158 , with the remaining components removed for illustration purposes. Figure 7 1 is a perspective view of a slider 160 of a locking mechanism 158, which is removed from the handle 112 for illustrative purposes. The locking mechanism 158 includes a slider 160 that can be accessed and operated from the exterior of the housing 114 of the handle 112 and a spring 168 disposed within a recess within the housing 114. A proximal end 164 of the slider 160 abuts against and contacts the spring 168. The slider 160 has a tooth or tip 166 formed at a distal end 162 thereof that is configured to selectively engage or mate with a plurality of teeth 122 formed on the proximal surface 120 of the nose cone 118. When the tip 166 of the slider 160 engages or mates with one of the plurality of teeth 122 of the nose cone 118, the nose cone 118 is in a locked configuration and cannot be turned or rotated by a user. In other words, the tip of the slider 160 engages into one of the plurality of teeth 122 of the nose cone 118 to hold the nose cone 118 in the locked configuration. In this manner, the slider 160 locks the circumferential position of the nose cone 118 relative to the housing 114 of the handle 122. The user is thus prevented from inadvertently rotating or turning the nose cone 118 when the nose cone 118 is in the locked configuration.

[0056] When it is desired to torque the shaft 102 of the catheter 100, the slider 160 is retracted proximally such that the tip 166 of the slider 160 is disengaged from the teeth 122 of the nose cone 118, thereby releasing the nose cone 118 to an unlocked configuration. When retracted in the proximal direction, the slider 160 compresses the spring 168 and is allowed to move in the proximal direction to disengage the nose cone 118. When in the unlocked configuration, the nose cone 118 can be rotated to torque the catheter 100. Once the catheter 100 is torqued as desired, the user can release the slider 158, causing the spring 168 to return to its uncompressed configuration, thereby urging the slider 158 distally to re-engage with the nose cone 118, such that the tip 166 of the slider 160 is located within one of the plurality of teeth 122 of the nose cone 118. In other words, when the slider 160 is released, the tension within the spring 168 and the sufficient resiliency of the spring 168 cause the slider 160 to move distally and contact the proximal surface 120 of the nose cone 118, thereby securing the nose cone 118 in its locked configuration.

[0057] Fig. 8A and Figure 8B 1 is a perspective view of a portion of the shaft 102 and the strain relief assembly 170, which has been removed from the catheter 100 for illustrative purposes. The shaft 102 is an elongated tubular or cylindrical member that defines a central lumen 110 extending from its proximal end 104 to its distal end 106. The central lumen 110 opens at the distal end 106 of the shaft 102, which in turn forms the distal end of the catheter 100. In an embodiment of the present invention, the central lumen 110 is sized or configured to slidably receive a guidewire therethrough. The shaft 102 includes an elongated slot or channel 108 formed through its sidewall. As will be described herein with respect to Fig.18 and Fig.19 As described in more detail, the elongated slot 108 is disposed in the handle 112, distal to the bearing 126, and is used to allow the pull wire 146 to exit from the central lumen 110. In an embodiment, the shaft 102 can be sized to be used with an introducer sheath, wherein the central lumen 110 is sized to accommodate a guide wire having an outer diameter of 0.035 inches. The proximal end 104 of the shaft 102 extends out of the patient's body and is disposed in the handle 112.

[0058] The shaft 102 also includes an inflation lumen (not shown) to allow inflation fluid to be delivered to the balloon. In an embodiment, the inflation lumen is preformed in the sidewall of the shaft 102 and can be formed, for example, by extrusion of a multi-lumen profile. The inflation lumen extends adjacent to or parallel to the central lumen 110, but terminates at the balloon 105, close to the distal end 106 of the shaft 102. The inflation lumen is in fluid communication with the interior of the balloon 105 to allow inflation fluid to be delivered to the interior of the balloon 105 and radially expand the balloon 105 when necessary. In another embodiment, as will be understood by those of ordinary skill in the art of balloon catheter construction, the inflation lumen can be optionally formed via an annular space formed between inner shaft components concentrically disposed within the shaft 102, or via an elongated inflation tube disposed within and attached to the shaft 102. Those of ordinary skill in the art of balloon catheter design will also understand that a Luer connector 178 or some other type of connector can be connected to an inflation fluid source (not shown), and can be another structure or configuration without departing from the scope of the present invention.

[0059] The shaft 102 can be formed of one or more polymeric materials, non-exhaustive examples of which include laminated, blended or coextruded polyethylene, polyethylene block amide copolymer (PEBA), polyamide and / or combinations thereof. Optionally, the shaft 102 or some portion thereof can be formed as a composite material having a reinforcing layer incorporated into a polymeric body to increase strength and / or flexibility. Suitable reinforcing layers include braids, mesh layers, embedded axial wires, embedded spiral or circumferential wires, sea wave tubes, and the like. For example, in one embodiment, at least the proximal portion of the shaft 102 can be formed by a reinforced polymeric tube. According to embodiments of the present invention, the balloon 105 can be formed of any suitable polymeric material for the manufacture of an expansion balloon, such as polyether block amide (PEBA) and polyurethane (PU), and can have an outer diameter in the range of 2 to 4 mm and a length in the range of 5 to 15 mm.

[0060] The strain relief assembly 170 is concentrically disposed on a portion of the shaft 102 at the distal end of the housing 114 and is used to relieve stress from the shaft 102 as the shaft 102 exits the distal end of the housing 114. The strain relief assembly 170 is a relatively short tubular assembly that defines a cavity therethrough extending from its proximal end 174 to its distal end 176. The proximal end 174 includes a radial flange 175 that is attached to the interior of the nose cone 118. As will be described herein with respect to Figures 20 to 30As described in more detail, the distal end 176 of the strain relief assembly 170 extends or protrudes from the distal end of the housing 114 of the handle 112 and includes a circumferential ridge or raised ring 177 configured to mate with the valve pressure relief assembly. As will be described in more detail herein, the valve pressure relief assembly is an assembly that is slidably disposed on the outer surface of the shaft 102 and is configured to be selectively disposed on the balloon expandable prosthesis 101 to protect the balloon expandable prosthesis 101 during insertion of the introducer sheath. When the valve pressure relief assembly is not disposed on the balloon expandable prosthesis 101, the strain relief assembly 170 is configured to serve as a docking station for the valve pressure relief assembly. The valve pressure relief assembly is secured or docked to the raised ring 177 of the strain relief assembly 170 by an interference fit.

[0061] The torque mechanism 116 of the handle 112 will now be described in more detail. The torque mechanism 116 includes a nose cone 118 and a bearing 126, which can be rotatably coupled together so that rotation of the nose cone 118 also causes rotation of the bearing 126. The bearing 126 can also be rotatably coupled to the shaft 102 so that rotation of the bearing 126, which is concentrically disposed on the shaft 102, further causes rotation of the shaft 102. Thus, the torque mechanism 116 allows the distal portion of the catheter 100 to be rotated by rotating the nose cone 118 of the handle 112.

[0062] More specifically, Fig.9A and Fig. 9B The nose cone 118 is depicted removed from the handle 112 for illustration purposes only. Fig.9A is a perspective cutaway view of the nose cone 118, and Fig. 9B 1 is a perspective view of the distal portion of the nose cone 118. The nose cone 118 is accessible and operable from the exterior of the housing 114. The nose cone 118 has a truncated hollow cone configuration such that the shaft 102 extends therethrough. Figure 6 and Figure 7 As depicted, the proximal surface 120 of the nose cone 118 includes a plurality of teeth 122 that interact with the locking mechanism 158. The nose cone 118 also includes a circumferential groove 119 formed on its outer surface for coupling the nose cone 118 to the distal end of the housing 114. The nose cone 118 further includes first and second fingers 124A, 124B extending proximally from the proximal surface 120 of the nose cone 118. The first and second fingers 124A, 124B are disposed at opposing locations on the circumference of the nose cone 118, and as shown in FIG. Fig.11 , for coupling nose cone 118 to bearing 126, Fig.11 It is a combination of nose cone 118 and bearing 126.

[0063] Fig.10 , Fig. 10A and Fig. 10BThe bearing 126 is depicted removed from the handle 112 for illustration purposes only. Fig.10 is a perspective view of the bearing 126, Fig. 10A is its side view, Fig. 10B 1 is a front view thereof. A bearing 126 is disposed within the interior of the housing 114 of the handle 112. The bearing 126 is a tubular component that defines a cavity 128 therethrough. The bearing 126 is concentrically disposed on the shaft 112 such that the shaft 112 extends through the cavity 128. The bearing 126 also includes a radial flange 130 at a proximal end thereof. The radial flange 130 includes first and second slots 132A, 132B formed therethrough. The first and second slots 132A, 132B are sized and configured to receive the first and second fingers 124A, 124B of the nose cone 118, respectively. As shown in FIG. Fig.11 As best shown in FIG. 1 , the first and second fingers 124A, 124B will extend through the first and second slots 132A, 132B, respectively, and be secured within the first and second slots 132A, 132B by an interference fit. Fig.11 is an assembly of the nose cone 118 and the bearing 126. The bearing 126 is coupled to the nose cone 118 via the first and second fingers 124A, 124B so as to be rotatable therewith.

[0064] The bearing 126 is configured to transfer torque or drive to the shaft 102 when the bearing 126 is rotated. In an embodiment, the bearing 126 is a roller type bearing in which torque is positively transferred by rollers (not shown) wedged into an internal ramp, or it can be another type of one-way bearing known in the art. When the nose cone 118 is rotated in either direction, i.e., counterclockwise or clockwise, the bearing 126 transfers torque from the nose cone 118 to the shaft 102. Therefore, when the user rotates the nose cone 118, the bearing 126 and the shaft 102 rotate with the nose cone 118. The rotation of the nose cone 118 causes the entire length of the shaft 102 to rotate with it, and thus the torque mechanism 116 can be used for the distal portion of the torque catheter 100.

[0065] The steering mechanism 144 of the handle 112 will now be described in more detail. The steering mechanism 144 includes a knob 152 that can rotate relative to the housing 114 of the handle 112, a rack 134 that is concentrically disposed within the knob 152 and is coupled to the bearing 126, and a pull wire 146 (described below with respect to FIG. Fig.18 and Fig.19 106). A pull wire 146 is attached to the distal end 106 of the shaft 102 to be selectively tensioned to bend the distal end 106 of the catheter. In other words, when the pull wire 146 is retracted via the steering mechanism 144, the pull wire 16 is placed under tension and bends the distal portion of the catheter 100.

[0066] Fig.12A perspective view of the rack 134 is depicted, removed from the handle 112 for illustration purposes only. The rack 134 is a tubular assembly that defines a lumen 136 therethrough such that the shaft 102 extends through the rack 134. The rack 134 is disposed within the interior of the housing 114 of the handle 112. As will be described in greater detail herein, the rack 134 includes a series of protrusions 140 formed on an outer surface 138 thereof for interacting with the knob 152. The rack 134 also includes first and second tabs or clips 142A, 142B extending distally from the distal end of the rack 134. The first and second clips 142A, 142B are disposed at opposing locations on the circumference of the rack 134, and as shown in FIG. Fig.15 , for coupling the rack 134 to the bearing 126, Fig.15 FIG. 1 is a side view of the assembly of the rack 134 and the bearing 126. Fig.15 As shown, the rack 134 is positioned against or directly adjacent to the bearing 126, wherein the bearing 126 extends or protrudes distally from the distal end of the rack 134. The first and second clips 142A, 142B extend over the radial flange 130 and couple the bearing 126 to the rack 134 so that the bearing 126 can slide therewith. However, when the bearing 126 rotates with the nose cone 118 as described above during actuation of the torque mechanism 116, the bearing 126 rotates relative to the rack 134 or rotates freely within the rack 134. Therefore, the first and second clips 142A, 142B couple the bearing 126 to the rack 134 so that the bearing 126 can slide therewith, while still allowing the bearing 126 to rotate or rotate freely within the rack 145.

[0067] Fig.13 The knob 152 is shown in a perspective view, removed from the handle 112 for illustration purposes only. The knob 152 can be accessed and operated from the outside of the housing 114. Fig.14 As best shown in FIG. 1 , the knob 152 is concentrically disposed on the rack 134. Fig.141 is a perspective view of the assembly of the rack 134 and the knob 152. The knob 152 includes threads 156 on its inner surface 154, and the threads 156 are configured to mate or mesh with a series of protrusions 140 formed on the outer surface 138 of the rack 134. In other words, the threaded inner surface 154 of the knob 152 is threadingly engaged with the outer surface 138 of the rack 134. More specifically, the threads 156 are continuous helical ridges that circumscribe the inner surface of the knob 152. The threads 156, sometimes referred to as a continuous thread or a series of threads, have a rounded sinusoidal profile that mates or meshes with a series of protrusions 140 formed on the outer surface 138 of the rack 134. As used herein, the rounded sinusoidal profile of the threads 156 means that the continuous helical ridges forming the threads 156 have a rounded or smooth crown, and the windings of the continuous helical ridges collectively have a sinusoidal or wavy profile. In alternative embodiments, other thread profiles may be formed on the threaded inner surface 138 of the knob 152 that mate or mesh with a series of protrusions 140 formed on the outer surface 138 of the rack 134 .

[0068] The threads 156 and a series of protrusions 140 formed on the outer surface 138 of the rack 134 are used to convert rotational movement into translational or linear movement. More specifically, the rack 134 is disposed within the housing 114 of the handle 112 such that the rack 134 is prevented from rotating relative to the housing 114. Fig.16 As shown, the housing 114 includes a circumferential groove or groove 113 formed thereon, which is configured to accommodate the knob 152. An opening 115 within the circumferential groove 113 is formed in the side wall of the housing 114. Fig.1713, the opening 115 allows for interaction between the threads 156 formed on the inner surface 154 of the knob 152 and the series of protrusions 140 formed on the outer surface 138 of the rack 134. More specifically, the series of protrusions 140 formed on the outer surface 138 of the rack 134 extend radially outward into the circumferential groove 113 of the housing 114 and cooperate or mesh with the threads 156 of the knob 152. Further, because the series of protrusions 140 formed on the outer surface 138 of the rack 134 extend through the opening 115 of the housing 114, the wall of the housing 114 forming the opening 115 prevents the rack 134 from rotating relative to the housing 114. The wall of the housing 114 forming the opening 115 extends on either side of the series of protrusions 140 formed on the outer surface 138 of the rack 134 and thus acts as a stop or obstacle when the rack 134 attempts to rotate. Thus, because the rack 134 is prevented from rotating relative to the housing 114 as described above, and because the knob 152 is also prevented from axial movement due to being seated in the circumferential groove 113 of the housing 114, the rotational movement of the knob 152 is converted into a translational or linear movement of the rack 134 due to the threaded relationship between the threads 156 and the series of protrusions 140 formed on the outer surface 138 of the rack 134. When the knob 152 is rotated in a first direction, i.e., clockwise, the threaded relationship between the knob 152 and the rack 134 causes the rack 134 to move axially or longitudinally in the proximal direction. Conversely, when the knob 152 is rotated in a second direction opposite to the first direction, i.e., counterclockwise, the threaded relationship between the knob 152 and the rack 134 causes the rack 134 to move axially or longitudinally in the distal direction.

[0069] When the rack 134 is moved axially forward and backward by the rotation of the knob 152, the bearing 126 can be moved axially forward and backward by the rotation of the knob 152. Fig.15 The first and second clips 142A, 142B are described to slide on the shaft 102 together with the rack 134. Further, the pull wire 146 is attached to the bearing 126. Therefore, the rotation of the knob 152 causes the axial movement of the rack 134 and the bearing 126 coupled thereto, thereby tensioning the pull wire 146 to bend the distal portion of the shaft 102. More specifically, Fig.18 A perspective view of the catheter 100 is depicted with the housing 114 of the handle 112 removed for illustration purposes, and a puller wire 146 of the steering mechanism 144 is shown in phantom within the catheter 100. The puller wire 146 has a proximal end 148 attached to the bearing 126 and a distal end 150 attached to the distal portion of the shaft 102. Fig.19 As best shown, the pull wire 246 is disposed within the central lumen 110 of the shaft 102 and the pull wire 146 is passed through the elongated slot 108 of the shaft 102 such that the proximal end 148 of the pull wire 146 is attached to the bearing 126. Fig.19 yes Fig.18108, which depicts the pull wire 146 exiting the shaft 102 via the elongated slot 108. In the embodiment described herein, the pull wire 146 is formed of stainless steel, and a distal end 150 of the pull wire 146 is attached to the shaft 102 using a metal band or ring (not shown). The distal end 150 of the pull wire 146 is attached to the metal band by welding. In another embodiment of the present invention, the pull wire 146 is formed of KEVLAR or another relatively hard polymeric material, and the polymeric material of the distal end 150 is reflowed to attach the distal end 150 of the pull wire 146 to the shaft 102. Other conventional techniques, including bonding or adhesives, may alternatively be used to attach the distal end 150 of the pull wire 146 to the shaft 102, and one of ordinary skill in the art will appreciate that the attachment method depends on the material of the pull wire 146.

[0070] The pull wire 146 is selectively tensioned via the steering mechanism 144 to bend the distal end 106 of the catheter. More specifically, the rotation of the knob 152 causes axial movement of the rack 134 and the bearing 126 coupled thereto as described above. The bearing 126 slides relative to the shaft 102 and relative to the nose cone 118 during its axial movement. Since the pull wire 146 is attached to the bearing 126, the axial movement of the rack 134 and the bearing 126 coupled thereto tensions the pull wire 146 to bend the distal portion of the shaft 102. More specifically, when the bearing 126 and the pull wire 146 coupled thereto are retracted proximally via the steering mechanism 144, the pull wire 146 is placed under tension and the distal portion of the shaft is bent to a radius of curvature. The size of the radius of curvature depends on the intended application of the catheter 100, the target anatomical structure using the catheter 100, and / or the size or profile of the catheter 100. In an embodiment where the catheter 100 is used for a transcatheter aortic valve implantation (TAVI) procedure, the radius of curvature ranges from twenty (20) millimeters to sixty (60) millimeters. In another embodiment of the present invention where the catheter 100 is used for a neurological application, the radius of curvature can be as small as 0.5 centimeters. The user can access the steering mechanism 144 via the handle 112, and the curvature of the distal portion of the catheter 100 can be changed based on the user manipulating the steering mechanism 144 via the knob 152 of the handle 112.

[0071] It is noteworthy that both the torque mechanism 116 and the steering mechanism 144 are integrated into the handle 112 so that the operation of the torque mechanism 116 does not interfere with the operation of the steering mechanism 144, and vice versa. When the steering mechanism 144 is actuated via the rotation of the knob 152, the rack 134 and the bearing 126 coupled thereto move axially or longitudinally relative to the shaft 102 and the nose cone 118 as described above without interfering with the torque mechanism. When the torque mechanism 116 is actuated via the rotation of the nose cone 118, the bearing 126 rotates the shaft 102 as described above and rotates relative to the rack 134 or rotates freely within the rack 134 without interfering with the steering mechanism 144. When the catheter 100 is torqued via the rotation of the nose cone 118, the pull wire 146, which is proximally attached to the bearing 126, rotates to the same angle as the shaft 102.

[0072] As previously described, the valve pressure relief assembly can be used with the catheter 100. Turning now to Fig. 20 , which shows a side view of a valve pressure relief assembly 2080 that can be used with the catheter 100. The valve pressure relief assembly 2080 includes a proximal end 2082 and a distal end 2084. A hub 2090 including a hemostatic valve or seal is disposed at the proximal end 2082 of the valve pressure relief assembly 2080. The hemostatic valve or seal of the hub 2090 can be formed of a flexible material such as silicone and can include a lubricating coating such as parylene or silicone oil. The hemostatic valve or seal of the hub 2090 is configured to passively or actively seal against the shaft 102 when the shaft 102 is disposed therethrough, thereby producing hemostasis.

[0073] The sheath 2086 extends distally from the hub 2090. The sheath 2086 is a tubular or cylindrical element that defines a single lumen 2087 therethrough. The sheath 2086 is sized to be used with an introducer sheath having a lumen 2087, wherein the lumen 2087 is sized or configured to slidably accommodate the shaft 102 of the catheter 100, including the distal portion of the shaft 102 on which the balloon-expandable prosthesis 101 is disposed. The sheath 2086 has a sufficient length to cover or extend over the entire or entire length of the balloon-expandable prosthesis 101 in the delivery or compressed configuration, and thus the specific length of the sheath 2086 can vary depending on the application and length of the balloon-expandable prosthesis 101.

[0074] The sheath 2086 can be formed of one or more relatively rigid polymeric materials, such as but not limited to nylon. Optionally, the sheath 2086 or some portion thereof can be formed as a composite material having a reinforcing layer incorporated into a polymeric body to increase strength and / or flexibility. Suitable reinforcing layers include braids, mesh layers, embedded axial wires, embedded spiral or circumferential wires, hypotubes, and the like. For example, in one embodiment, the entire length of the sheath 2086 is formed by a reinforced polymeric tube. In an embodiment, the sheath 2086 is translucent to allow visual inspection of the balloon-expandable prosthesis 101 when the sheath 2086 is placed thereon. In another embodiment, the sheath 2086 can be opaque.

[0075] Fig.21 2 is a side view of a valve pressure relief assembly 2080 slidably disposed on the shaft 102 of the catheter 100. As previously described, the catheter 100 includes a handle 112, the shaft 102 extending distally from the handle 112, a strain relief assembly 170 concentrically disposed on a portion of the shaft 102 and extending distally from the handle 112, and a balloon-expandable prosthesis 101 disposed on the distal portion of the shaft 102. The valve pressure relief assembly 2080 is slidably disposed on an outer surface of the shaft 102. The valve pressure relief assembly 2080 can slide relative to the shaft 102 of the catheter 100 so that the valve pressure relief assembly 2080 can be easily moved along the shaft 102 in the longitudinal direction indicated by the directional arrow 2092. In this way, the valve pressure relief assembly 2080 is configured to be selectively disposed on the balloon-expandable prosthesis 101 to be inserted into the catheter 100 during the insertion of the guide sheath ( Fig.21 More specifically, Fig. 22 2 is a side view of the distal portion of the catheter 100, wherein the sheath 2086 of the valve pressure relief assembly 2080 is disposed on the balloon expandable prosthesis 101. When positioned on the balloon expandable prosthesis 101, the valve pressure relief assembly 2080 reduces or eliminates the external forces experienced by the balloon expandable prosthesis 101 when it is loaded through the hemostatic valve of the introducer sheath, such as Fig.23 shown. Fig.23 is a side view of the distal portion of the catheter 100 being inserted through the hub 2394 of the introducer sheath 2395 with the valve pressure relief assembly 2080 positioned on the balloon expandable prosthesis 101. The hub 2394 of the introducer sheath 2395 includes a hemostasis valve and a flush port 2396 therein.

[0076] For example, in an embodiment, the balloon-expandable prosthesis 101 is a transcatheter aortic valve replacement prosthesis. When such a transcatheter aortic valve replacement prosthesis is inserted into the hub 2394 of the guide sheath 2395, the tissue of the transcatheter aortic valve replacement prosthesis contacts the hemostatic valve of the hub 2394 of the guide sheath 2395. The hemostatic valve of the hub 2394 of the guide sheath 2395 may exert sufficient force on the transcatheter aortic valve replacement prosthesis to damage and / or displace the transcatheter aortic valve replacement prosthesis. However, when the valve pressure relief assembly 2080 is positioned on the transcatheter aortic valve replacement prosthesis, the valve pressure relief assembly 2080 protects the transcatheter aortic valve replacement prosthesis from damage or displacement by reducing or eliminating the external force to which the transcatheter aortic valve replacement prosthesis is subjected when it is loaded through the hemostatic valve of the guide sheath 2395.

[0077] After advancement through the introducer sheath 2395, the valve pressure relief assembly 2080 no longer needs to be positioned on the balloon expandable prosthesis 101 at the insertion site. Thus, the valve pressure relief assembly 2080 is configured to dock onto the handle 112 of the catheter 100, such as Fig.24 More specifically, when the valve pressure relief assembly 2080 is not positioned on the balloon-expandable prosthesis 101, the strain relief assembly 170 of the handle 112 of the catheter 100 is configured to serve as a docking station for the valve pressure relief assembly 2080. Fig. 8A and Figure 8B As depicted, the distal end 176 of the strain relief assembly 170 extends or protrudes from the distal end of the housing 114 of the handle 112 and includes a raised ring 177. The valve pressure relief assembly 2080 is secured or docked to the raised ring 177 of the strain relief assembly 170 by an interference fit between the raised ring 177 and the inner surface of the valve pressure relief assembly 2080. When the valve pressure relief assembly 2080 is docked or secured to the strain relief assembly 170, the torque mechanism 116 and the steering mechanism 144 can still be actuated via the nose cone 118 and the knob 152, respectively. After being docked to the strain relief assembly 170, the valve pressure relief assembly 2080 cannot slide freely along the catheter 102, which may be troublesome for the user.

[0078] When the procedure is performed, any number of techniques may be used to advance a guidewire (not shown) within the blood vessel and to advance the guide sheath 2395 along the guidewire. The catheter 100 is then loaded onto the guidewire. The valve pressure relief assembly 2080 is longitudinally slid or moved on the shaft 102 of the catheter until the sheath 2086 of the valve pressure relief assembly 2080 covers the balloon expandable prosthesis 101. With the valve pressure relief assembly 2080 covering the balloon expandable prosthesis 101, the valve pressure relief assembly 2080 and the distal portion of the catheter 100 are advanced distally by the hub 2394 of the guide sheath 2395. In an embodiment, the hub 2394 of the guide sheath 2395 includes a stopper (not shown) therein to prompt the user that the valve pressure relief assembly 2080 has been inserted into the guide sheath 2395 to a sufficient depth. More specifically, the stopper prompts the user that the balloon expandable prosthesis 101 has completely passed through the hemostatic valve of the guide sheath 2395 and prevents the user from further inserting the valve pressure relief assembly 2080. In an embodiment, the stopper may be an integral flange or step formed on the inner surface of the hub 2394 of the introducer sheath 2395, the flange or step having a diameter that is smaller than the outer diameter of the valve pressure relief assembly 2080. After the valve pressure relief assembly 2080 contacts the stopper within the hub 2394 of the introducer sheath 2395, the valve pressure relief assembly 2080 may be slid in the proximal direction along the shaft 102 and docked to the strain relief assembly 170 of the handle 112 of the catheter 100.

[0079] Fig.25A Another embodiment of a valve pressure relief assembly 2580 that can be used with the catheter 100 is depicted. Similar to the valve pressure relief assembly 2080, the valve pressure relief assembly 2580 includes a proximal end 2582 and a distal end 2584. A hub 2590 including a hemostatic valve or seal is disposed at the proximal end 2582 of the valve pressure relief assembly 2580. A flush port 2581 is provided on the hub 2590. The hemostatic valve or seal of the hub 2590 can be formed of a flexible material such as silicone and can include a lubricating coating such as parylene or silicone oil. The hemostatic valve or seal of the hub 2590 is configured to passively or actively seal the shaft 102 when the shaft 102 is disposed therethrough, thereby producing hemostasis.

[0080] The sheath 2586 extends distally from the hub 2590. The sheath 2586 is a tubular or cylindrical element that defines a single lumen 2587 therethrough. The sheath 2586 is sized to be used with an introducer sheath having a lumen 2587, wherein the lumen 2587 is sized or configured to slidably accommodate the shaft 102 of the catheter 100, including the distal portion of the shaft 102 on which the balloon-expandable prosthesis 101 is disposed. The sheath 2586 has a sufficient length to cover or extend over the entire or entire length of the balloon-expandable prosthesis 101 in the delivery or compressed configuration, and thus the specific length of the sheath 2586 can vary depending on the application and length of the balloon-expandable prosthesis 101.

[0081] The sheath 2586 can be formed of one or more relatively rigid polymeric materials, such as but not limited to polyethylene. Optionally, the sheath 2586 or some portion thereof can be formed as a composite material having a reinforcing layer incorporated into a polymeric body to improve strength and / or flexibility. Suitable reinforcing layers include braids, mesh layers, embedded axial wires, embedded spiral or circumferential wires, hypotubes, etc. For example, in one embodiment, the entire length of the sheath 2586 is formed by an enhanced polymeric tube. In this embodiment, the sheath 2586 is opaque. In another embodiment, the sheath 2586 is translucent to allow visual inspection of the balloon-expandable prosthesis 101 when the sheath 2586 is placed thereon.

[0082] Similar to the valve pressure relief assembly 2080, the valve pressure relief assembly 2580 can slide relative to the shaft 102 of the catheter 100 so that the valve pressure relief assembly 2580 can be easily moved along the shaft 102 in the longitudinal direction. In this way, the valve pressure relief assembly 2580 is configured to be selectively placed on the balloon expandable prosthesis 101 to protect the balloon expandable prosthesis 101 during insertion of the guide sheath. More specifically, Fig.25B is a side view of the distal portion of the catheter 100 with the sheath 2586 of the valve pressure relief assembly 2580 positioned on the balloon expandable prosthesis 101. As described above with respect to the valve pressure relief assembly 2580, when positioned on the balloon expandable prosthesis 101, the valve pressure relief assembly 2580 reduces or eliminates the external forces experienced by the balloon expandable prosthesis 101 when loaded through the hemostatic valve of the introducer sheath.

[0083] After advancement through the introducer sheath, the valve pressure relief assembly 2580 no longer needs to be positioned on the balloon expandable prosthesis 101. Thus, as described above with respect to the valve pressure relief assembly 2080, the valve pressure relief assembly 2580 is configured to be docked to the handle 112 of the catheter 100, such as Fig.25C A side view of the catheter 100 is shown.

[0084] For the purpose of illustration, Fig.26 1, the strain relief assembly 170 of the handle 112 of the catheter 100 is removed from the catheter. As described above, the strain relief assembly 170 is a relatively short tubular assembly that defines a lumen extending therethrough from its proximal end 174 to its distal end 176. The proximal end 174 includes a tube configured to attach to the nose cone 118 (at Fig.26101). The distal end 176 of the strain relief assembly 170 extends or protrudes from the distal end of the housing 114 of the handle 112 and includes a raised ring 177 that is configured to provide an interference fit with the valve pressure relief assembly 2080, 2580. The valve pressure relief assembly 2080, 2580 is disposed on the tubular body of the strain relief assembly 170, wherein the raised ring 177 contacts the inner surface of the valve pressure relief assembly 2080, 2580. As described herein, when the valve pressure relief assembly 2080, 2580 is not disposed on the balloon-expandable prosthesis 101, the strain relief assembly 170 is configured to serve as a docking station for the valve pressure relief assembly 2080, 2580. The valve pressure relief assembly 2080, 2580 is fixed or docked to the raised ring 177 of the strain relief assembly 170 by an interference fit.

[0085] The strain relief assembly 170 may have an optional configuration to accommodate and secure the valve pressure relief assembly 2080, 2580 thereto. Fig. 27 27. A strain relief assembly 2770 that may be used in embodiments of the present invention is shown in FIG. The strain relief assembly 2770 has a proximal end 2774 and a distal end 2776. The proximal end 2774 includes a proximal end 2776 configured to attach to the nose cone 118 (at Fig. 27 2794A, 2794B extend or protrude distally from the radial flange 2775. The first and second tabs 2794A, 2794B each include a rounded tip 2795A, 2795B at a distal end thereof, respectively, which is configured to provide an interference fit with the valve pressure relief assembly 2080, 2580. The valve pressure relief assembly 2080, 2580 is seated on the first and second tabs 2794A, 2794B, wherein the rounded tips 2795A, 2795B contact the inner surface of the valve pressure relief assembly 2080, 2580. When the valve pressure relief assembly 2080, 2580 is not seated on the balloon-expandable prosthesis 101, the strain relief assembly 2770 is configured to serve as a docking station for the valve pressure relief assembly 2080, 2580. The valve pressure relief assembly 2080, 2580 is fixed or docked to the first and second tabs 2794A, 2794B of the strain relief assembly 2770 by an interference fit with the rounded tips 2795A, 2795B. The strain relief assembly 2770 is configured to be concentrically disposed on a portion of the shaft 102 at the distal end of the housing 114 and is configured to relieve stress from the shaft 102 when the shaft 102 is removed from the distal end of the housing 114.

[0086] In another example, in Fig.28 28. The strain relief assembly 2870 that may be used in embodiments of the present invention is shown in FIG. The strain relief assembly 2870 has a proximal end 2874 and a distal end 2876. The proximal end 2874 includes a proximal end 2876 configured to attach to the nose cone 118 (at Fig.28 101). The strain relief assembly 2870 includes a radial flange 2875 disposed inside the radial flange 2875 (not shown). A plurality of pins 2896 extend or protrude distally from the radial flange 2875 and are configured to accommodate the valve pressure relief assembly 2080, 2580. Each pin 2896 includes a shank 2897 extending radially inward at its distal end. The valve pressure relief assembly 2080, 2580 is disposed within the pins 2896, wherein the shank 2897 contacts the outer surface of the valve pressure relief assembly 2080, 2580. The shank 2897 is configured to provide an interference fit with the valve pressure relief assembly 2080, 2580. When the valve pressure relief assembly 2080, 2580 is not disposed on the balloon-expandable prosthesis 101, the strain relief assembly 2870 is configured to serve as a docking station for the valve pressure relief assembly 2080, 2580. The valve pressure relief assembly 2080, 2580 is secured or docked into the plurality of pins 2896 of the strain relief assembly 170 by an interference fit with the tangs 2897 of the plurality of pins 2896. The strain relief assembly 2870 is configured to be concentrically disposed on a portion of the shaft 102 at the distal end of the housing 114 and is configured to relieve stress from the shaft 102 as the shaft 102 moves away from the distal end of the housing 114.

[0087] In another example, in Fig.29 29. The strain relief assembly 2970 that may be used in embodiments of the present invention is shown in FIG. The strain relief assembly 2970 has a proximal end 2974 and a distal end 2976. The proximal end 2974 includes a proximal end 2976 configured to attach to the nose cone 118 (at Fig.29 The first and second planar spring elements 2998A, 2998B extend or protrude distally from the radial flange 2975 and are configured to accommodate the valve pressure relief assembly 2080, 2580. The first and second planar spring elements 2998A, 2998B are each shaped as Fig.29The strain relief assembly 2970 is configured to be configured to be deformed and elastically return to their shape-set configuration after deformation. The valve pressure relief assembly 2080, 2580 is disposed within the first and second planar spring elements 2998A, 2998B, wherein the first and second planar spring elements 2998A, 2998B contact the outer surface of the valve pressure relief assembly 2080, 2580. The first and second planar spring elements 2998A, 2998B are configured to provide an interference fit with the valve pressure relief assembly 2080, 2580. When the valve pressure relief assembly 2080, 2580 is not disposed on the balloon-expandable prosthesis 101, the strain relief assembly 2970 is configured to serve as a docking station for the valve pressure relief assembly 2080, 2580. The valve pressure relief assembly 2080, 2580 is fixed or docked into the first and second planar spring elements 2998A, 2998B of the strain relief assembly 170 by an interference fit with the first and second planar spring elements 2998A, 2998B of the strain relief assembly 170. The strain relief assembly 2970 is configured to be concentrically disposed on a portion of the shaft 102 at the distal end of the housing 114 and is configured to relieve stress from the shaft 102 as the shaft 102 exits the distal end of the housing 114 .

[0088] Fig.30 3070 is a perspective view of another magnetic coupling configuration that can be used in embodiments of the present invention, which can be used to couple the valve pressure relief assembly 2080, 2580 to the housing 114 of the handle 112. More specifically, the magnetic coupling 3070 includes first and second magnetic components 3072A, 3072B, respectively. The first magnetic component 3072A is attached to the proximal end 2082, 2582 of the valve pressure relief assembly 2080, 2580, respectively, and the second magnetic component 3072B is attached to the distal end of the housing 114 of the handle 112. The first and second magnetic components 3072A, 3072B can be operated to selectively and temporarily couple the valve pressure relief assembly 2080, 2580 and the handle 112 together. The coupling between the valve pressure relief assembly 2080, 2580 and the handle 112 is selectively achieved by means of the magnetic force between the first and second magnetic components 3072A, 3072B. Both the first and second magnetic components 3072A, 3072B may be formed of a magnetic material, or one of the first and second magnetic components 3072A, 3072B may be formed of a magnetic material and the other may be formed of a ferromagnetic material.

[0089] Although various embodiments according to the present invention have been described above, it should be understood that the embodiments are presented only by way of illustration and example and in a non-restrictive manner. It is obvious to those skilled in the relevant art that various changes can be made to the form and details therein without departing from the spirit and scope of the present invention. For example, a handle with both torque and steering mechanisms can be used for any type of catheter device. A catheter device with such a handle can include a strain relief assembly and a valve pressure relief assembly described herein, or can be used without a strain relief assembly and a valve pressure relief assembly. On the contrary, the strain relief assembly and the valve pressure relief assembly described herein can be incorporated into any type of catheter device, including a catheter device with a handle without the torque and steering mechanisms described herein. Therefore, the breadth and scope of the present invention should not be limited to any of the exemplary embodiments described above, but should only be defined in accordance with the attached claims and their equivalents. It should also be understood that each feature of each embodiment discussed herein and each feature of each reference cited herein can be used in combination with the features of any other embodiment. All patents and public documents discussed herein are incorporated herein by reference as a whole.

Claims

1. A catheter, comprising: handle; and A shaft extends from within the handle, the handle comprising a housing; and a torque mechanism disposed at least partially within the interior of the housing of the handle, the torque mechanism comprising a nose cone rotatable relative to the housing of the handle and a bearing coupled to the nose cone for rotation therewith, wherein The bearing is concentrically disposed on the shaft and is configured to transfer torque from the nose cone to the shaft when the nose cone rotates, wherein rotation of the nose cone causes the entire length of the shaft to rotate therewith, wherein the nose cone is accessible from the outside of the housing of the handle and the bearing is disposed within the interior of the housing of the handle, wherein the nose cone comprises first and second fingers extending proximally from a proximal end of the nose cone, the first and second fingers being disposed at opposite positions on a circumference of the nose cone, and wherein the bearing is coupled to the nose cone via the first and second fingers.

2. The catheter according to claim 1, wherein The bearing includes first and second slots formed through a radial flange of the bearing, the first and second slots configured to receive the first and second fingers extending proximally from the proximal end of the nose cone.

3. The catheter according to claim 1, wherein: The bearing is a roller type bearing.

4. The catheter according to claim 1, wherein The handle further comprises: A steering mechanism at least partially disposed within the interior of the housing of the handle, the steering mechanism comprising a knob rotatable relative to the housing of the handle, the knob having threads formed on an inner surface thereof; a rack concentrically disposed within the knob, the rack having a series of projections formed on an outer surface thereof, the series of projections being configured to mate with the threads formed on the inner surface of the knob, wherein the rack is coupled to the bearing so that the bearing can slide therewith, and a pull wire having a proximal end attached to the bearing and a distal end attached to the distal portion of the shaft, wherein rotation of the knob causes axial movement of the rack and the bearing coupled thereto, thereby tensioning the pull wire to bend the distal portion of the shaft.

5. The catheter according to claim 4, wherein: The bearing slides relative to the shaft and relative to the nose cone during its axial movement.

6. The catheter according to claim 5, wherein: The bearing rotates relative to the rack during rotation of the bearing.

7. The catheter according to claim 5, wherein: A radial flange is formed on the bearing, and the rack includes a clip extending therefrom, the clip being configured to attach to the radial flange to couple the rack and the bearing together such that the bearing can slide with the rack.

8. The catheter according to claim 4, wherein: The pull wire is disposed within a cavity of the shaft, and an elongated slot is formed in a side wall of the shaft to allow the pull wire to pass from the cavity of the shaft to the bearing.

9. The catheter of claim 1, further comprising a locking mechanism configured to lock a circumferential position of the nose cone relative to the housing of the handle.

10. The catheter according to claim 9, wherein The locking mechanism includes a slider accessible from an exterior of the housing of the handle, the slider having a tip formed at a distal end thereof, the tip being configured to selectively engage one of a plurality of teeth formed on a proximal surface of the nose cone.

11. The catheter of claim 1 , further comprising a Luer connector disposed within and attached to the housing of the handle, wherein The shaft is disposed through the luer connector, and the luer connector is configured to allow the shaft to rotate independently relative to the housing of the handle.

12. The catheter of claim 1, further comprising a strain relief assembly concentrically disposed on a portion of the shaft and extending from a distal end of the housing of the handle.

13. The catheter of claim 1, further comprising a balloon-expandable prosthesis disposed at a distal portion of the shaft.

14. The catheter of claim 13, further comprising a valve pressure relief assembly slidably disposed on an outer surface of the shaft, the valve pressure relief assembly being configured to be selectively disposed on the balloon-expandable prosthesis to protect the balloon-expandable prosthesis during insertion of the introducer sheath.

15. The catheter of claim 14, further comprising a strain relief assembly concentrically disposed on a portion of the shaft and extending from a distal end of the housing of the handle, wherein The strain relief assembly is configured to function as a docking station for the valve pressure-relief assembly when the strain relief assembly is not disposed on the balloon-expandable prosthesis.

16. A catheter comprising: handle; and A shaft extends from within the handle, the handle comprising case; an actuating member, the actuating member being rotatable relative to the housing of the handle; a tubular element disposed within the housing and above the shaft, wherein the tubular element is coupled to the actuator such that the tubular element rotates with the actuator and is axially movable relative to the actuator; and a rack disposed within the housing and axially movable relative to the housing of the handle, wherein the tubular element is coupled to the rack such that the tubular element moves axially with the rack and is rotatable relative to the rack; and A pull wire has a proximal end attached to the tubular element and a distal end attached to the distal portion of the shaft, wherein axial movement of the rack tensions the pull wire to bend the distal portion of the shaft.

17. The catheter of claim 16, wherein: The shaft includes an elongated slot formed in a side wall thereof, and wherein the pull wire is disposed in a lumen of the shaft and passes through the elongated slot of the shaft.

18. The catheter of claim 16, wherein: The actuator is accessible from outside the housing of the handle.

19. The catheter of claim 16, wherein: The actuator is a nose cone, which includes first and second fingers extending proximally from a proximal end of the nose cone, the first and second fingers being disposed at opposite positions on the circumference of the nose cone, and wherein the tubular element is coupled to the nose cone via the first and second fingers.

20. The catheter of claim 19, wherein: The tubular member includes first and second slots configured to receive the first and second fingers extending proximally from the proximal end of the nose cone.

21. The catheter of claim 16, wherein: The handle further includes: a knob that is rotatable relative to the housing of the handle, and wherein the knob has threads formed on an inner surface thereof; and a rack that has a series of protrusions formed on an outer surface thereof, the series of protrusions being configured to cooperate with the threads formed on the inner surface of the knob, and wherein rotation of the knob causes axial movement of the rack and the tubular element coupled thereto.

22. The catheter of claim 16, wherein: A radial flange is formed on the tubular element, and the rack includes a clip extending therefrom, the clip being configured to attach to the radial flange to couple the rack and the tubular element together such that the tubular element moves with and is rotatable relative to the rack.

23. The catheter of claim 16, wherein: It further comprises a locking mechanism configured to lock the circumferential position of the actuator relative to the housing of the handle.

24. The catheter of claim 23, wherein: The locking mechanism includes a slider accessible from outside the housing of the handle, the slider having a tip formed at a distal end thereof, the tip being configured to selectively engage one of a plurality of teeth formed on a proximal surface of the actuator.

25. The catheter of claim 16, wherein: It further includes a Luer connector disposed within and attached to the housing of the handle, wherein the shaft is disposed through the Luer connector and the Luer connector is configured to allow the shaft to rotate independently relative to the housing of the handle.

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