Steerable catheter

Abstract

To provide steerable catheter devices and related methods, which can be used to deliver a medical device, tools, agents, or other therapy to a location within a body of a subject.SOLUTION: A steerable medical apparatus includes a shaft (14), a steering mechanism, and an actuation mechanism (48). The shaft has a proximal portion (16), a distal portion (18), a first pull wire (20), and a second pull wire (22). The steering mechanism has a first wheel and a second wheel coupled by a differential mechanism. The proximal ends of the first and second pull wires are respectively coupled to the first and second wheels. The actuation mechanism is coupled to the steering mechanism. Actuating the actuation mechanism in a first operational mode causes the distal portion of the shaft to curve in a first plane. Actuating the actuation mechanism in a second operational mode causes the distal portion of the shaft to curve away from the first plane.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] This application generally relates to steerable intravascular delivery devices and related methods.

Background Art

[0002] Intravascular delivery devices are used in a variety of procedures to deliver medical prosthesis devices or instruments to locations within the body that are not easily accessible surgically or where surgical access is undesirable. Access to a target location within the body can be achieved by inserting and guiding a delivery device through a body passageway or lumen, including but not limited to blood vessels, the esophagus, the trachea, any part of the gastrointestinal tract, and lymphatic vessels. In a specific example, an artificial heart valve is mounted on the distal end of a delivery device in a crimped state and can be advanced through a patient's vasculature (e.g., through the femoral artery and aorta) until the artificial valve reaches its implantation site within the heart. The artificial valve is then expanded to its functional size, for example, by inflating a balloon on which the artificial valve is mounted or by deploying the artificial valve from the sheath of the delivery device so that the artificial valve can self-expand to its functional size.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Patent Document 8

Patent Document 9

Patent Document 10

Summary of the Invention

Problems to be Solved by the Invention

[0004] The usefulness of a delivery device is largely limited by the device's ability to successfully pass through small blood vessels and around tight bends in the vasculature, such as around the aortic arch. Various techniques have been employed to adjust the curvature of a section of the delivery device to assist in "steering" an artificial valve through a bend in the vasculature. Nevertheless, an improved delivery device continues to be needed.

Means for Solving the Problems

[0005] Disclosed herein are steerable catheter devices and related methods that can be used to deliver a medical device, tool, substance, or other treatment to a location inside a subject's body. In some implementations, the steerable catheter device can be used to deliver a medical device through the vasculature, e.g., to a subject's heart.

[0006] Certain embodiments of the present disclosure relate to a steerable medical instrument including a shaft having a proximal portion and a distal portion. The delivery instrument may include a first pull wire having a proximal end and a distal end, and the distal end of the first pull wire may be coupled to the distal portion of the shaft. The delivery instrument may include a second pull wire having a proximal end and a distal end, and the distal end of the second pull wire may be coupled to the distal portion of the shaft. The delivery instrument may include a handle coupled to the proximal portion of the shaft. The handle may have a steering mechanism, which includes a first wheel and a second wheel operatively coupled by a differential mechanism. The proximal end of the first pull wire may be coupled to the first wheel, and the proximal end of the second pull wire may be coupled to the second wheel. Rotating both the first and second wheels in a first rotational direction may increase the tension of the first and second pull wires, whereby the distal portion of the shaft curves in a first angular direction within a first plane. Further, rotating only the first wheel in the first rotational direction may cause the second wheel to rotate in a second rotational direction opposite to the first rotational direction, increasing the tension of the first pull wire and decreasing the tension of the second pull wire, whereby the distal portion of the shaft curves in a second angular direction away from the first plane.

[0007] In some embodiments, rotating both the first and second wheels in a second rotational direction may decrease the tension of the first and second pull wires, whereby the distal portion of the shaft curves in a third angular direction opposite to the first angular direction within the first plane.

[0008] In some embodiments, rotating only the second wheel in the first rotational direction may cause the first wheel to rotate in the second rotational direction, increasing the tension of the second pull wire and decreasing the tension of the first pull wire, whereby the distal portion of the shaft curves in a fourth angular direction opposite to the second angular direction away from the first plane.

[0009] In some embodiments, the distal ends of the first and second pull wires may be spaced apart from each other at an angle of 180°.

[0010] In some embodiments, the second angular direction and the fourth angular direction may be in a second plane that is substantially perpendicular to the first plane.

[0011] In some embodiments, the distal end of the first pull wire and the distal end of the second pull wire are spaced apart from the distal end of the shaft by an equal distance.

[0012] In some embodiments, the delivery device may further include a first pull wire conduit and a second pull wire conduit, each of which extends at least partially through the proximal portion and the distal portion of the shaft. The first pull wire can extend through the first pull wire conduit, and the second pull wire can extend through the second pull wire conduit.

[0013] In some embodiments, the handle may include a first actuating mechanism operatively coupled to the steering mechanism, whereby when the first actuating mechanism is actuated, both the first and second wheels can selectively rotate in the first or second rotational direction.

[0014] In some embodiments, the handle may include a second actuating mechanism operatively coupled to the steering mechanism, whereby when the second actuating mechanism is actuated, only the first or second wheel can selectively rotate in the first rotational direction.

[0015] In some embodiments, the distal end of the first pull wire and the distal end of the second pull wire may be angled relative to the longitudinal axis of the shaft and spaced apart from each other by an angle that can be greater than 0° and less than 180°.

[0016] Certain embodiments of the present disclosure also relate to a steerable medical instrument including a shaft, a first pull wire, a second pull wire, a steering mechanism, and an actuation mechanism. The shaft may include a proximal portion and a distal portion. The first pull wire may have a proximal end and a distal end, and the distal end of the first pull wire is coupled to the distal portion of the shaft. The second pull wire may have a proximal end and a distal end, and the distal end of the second pull wire is coupled to the distal portion of the shaft. The steering mechanism may include a first wheel and a second wheel operatively coupled by a differential mechanism. The proximal end of the first pull wire may be coupled to the first wheel, and the proximal end of the second pull wire may be coupled to the second wheel. The actuation mechanism may be operatively coupled to the steering mechanism. When the actuation mechanism is actuated in a first mode of operation, the first and second wheels rotate in the same direction, and the distal portion of the shaft can curve in a first plane. When the actuation mechanism is actuated in a second mode of operation, the first and second wheels rotate in opposite directions, and the distal portion of the shaft can curve away from the first plane.

[0017] In certain embodiments, when both the first and second wheels are rotated in a first direction of rotation, the tension in the first and second pull wires can be increased, whereby the distal portion of the shaft curves in a first angular direction within the first plane.

[0018] In certain embodiments, when both the first and second wheels are rotated in a second direction of rotation opposite the first direction of rotation, the tension in the first and second pull wires can be decreased, whereby the distal portion of the shaft curves in a second angular direction opposite the first angular direction within the first plane.

[0019] In certain embodiments, when only the first wheel is rotated in the first direction of rotation, the second wheel can rotate in a second direction of rotation opposite the first direction of rotation, the tension in the first pull wire is increased, and the tension in the second pull wire is decreased, whereby the distal portion of the shaft curves in a first angular direction away from the first plane.

[0020] In certain embodiments, when only the second wheel is rotated in the first rotational direction, the first wheel can rotate in the second rotational direction, the tension of the second pull wire is increased, and the tension of the first pull wire is decreased, whereby the distal portion of the shaft curves away from the first plane in a second angular direction opposite to the first angular direction.

[0021] In certain embodiments, when the actuating mechanism is operated in the second operating mode, the distal portion of the shaft can curve within a second plane perpendicular to the first plane.

[0022] Also disclosed herein is a method of maneuvering a delivery device within a subject's vasculature. The method includes actuating a differential mechanism of the delivery device to curve a distal portion of a shaft of the delivery device within a first plane and actuating the differential mechanism to curve the distal portion of the shaft in a direction away from the first plane.

[0023] In certain embodiments, the differential mechanism can operably couple a first wheel and a second wheel. The first wheel can be coupled to a first pull wire, and the second wheel can be coupled to a second pull wire.

[0024] In certain embodiments, the act of actuating the differential mechanism to curve a distal portion of a shaft of the delivery device within a first plane can include rotating both the first and second wheels in a first rotational direction to increase the tension of the first and second pull wires, whereby the distal portion of the shaft can curve in a first angular direction within the first plane.

[0025] In certain embodiments, the act of actuating the differential mechanism to curve a distal portion of a shaft of the delivery device within a first plane can further include rotating both the first and second wheels in a second rotational direction opposite to the first rotational direction to decrease the tension of the first and second pull wires, whereby the distal portion of the shaft can curve in a second angular direction opposite to the first angular direction within the first plane.

[0026] In certain embodiments, the act of operating the differential mechanism to curve the distal portion of the shaft away from the first plane may include the step of rotating only the first wheel in a first rotational direction and rotating the second wheel in a second rotational direction opposite the first rotational direction, thereby increasing the tension of the first pull wire and decreasing the tension of the second pull wire, whereby the distal portion of the shaft can curve away from the first plane and in a first angular direction.

[0027] In certain embodiments, the act of operating the differential mechanism to curve the distal portion of the shaft away from the first plane may further include the step of rotating only the second wheel in the first rotational direction and rotating the first wheel in the second rotational direction, thereby increasing the tension of the second pull wire and decreasing the tension of the first pull wire, whereby the distal portion of the shaft can curve away from the first plane and in a second angular direction.

[0028] In certain embodiments, by the act of operating the differential mechanism to curve the distal portion of the shaft away from the first plane, the distal portion of the shaft can curve within a second plane perpendicular to the first plane.

[0029] The foregoing objects, features, and advantages of the present invention, as well as other objects, features, and advantages, will become more apparent from the following detailed description taken in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0030]

Figure 1

Figure 2

Figure 3A

Figure 3B

Figure 4

Figure 5

[0031] In certain embodiments, a steerable medical instrument that can be used to deliver a medical device, tool, substance, or other treatment to a location inside a subject's body may include one or more steerable catheters and / or sheaths. Examples of procedures where steerable catheters and sheaths are useful include cardiovascular, neurological, urological, gynecological, fertility (e.g., in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal procedures, and procedures involving access in any body conduit or cavity. Specific examples include implantation of implants, such as stents, grafts, embolization coils, etc.; positioning of its components, including imaging devices and / or ultrasonic transducers; and positioning of energy sources, RF sources, ultrasonic emitters, electromagnetic wave sources, laser light sources, heat sources, etc., for performing, for example, lithotripsy. In certain embodiments, the steerable medical instrument is a delivery instrument configured to deliver an implantable medical device, such as an artificial heart valve, to the patient's heart through the patient's vasculature. Thus, the following description is made with respect to a steerable delivery instrument. However, it should be understood that the embodiments disclosed herein can be incorporated into any steerable medical instrument that can be inserted into a patient's body to perform a medical treatment on the patient.

[0032] In some embodiments, the delivery instrument includes a steerable shaft, such as a guide sheath within which one or more delivery catheters are coaxially disposed therein. In a particular configuration, the delivery catheter may include one or more balloons or another type of expansion device at or near its distal end to expand an implantable medical device, such as an artificial heart valve.

[0033] Typically, the delivery device utilizes a pull wire having a distal end fixedly attached to the manipulable section and a proximal end operatively connected to an adjustment knob located on the handle of the delivery device outside the body. The pull wire is typically disposed within a pull wire lumen that extends longitudinally within or adjacent to the wall of the delivery device, such as a sheath or catheter. Adjusting the adjustment knob, for example rotating the knob, applies a pulling force to the pull wire, causing the pull wire to bend the manipulable section.

[0034] Some delivery devices utilize multiple pull wires so that the manipulable section can be curved in multiple dimensions. For example, some delivery devices have two pull wires, each having a distal end fixedly coupled to the manipulable section, and the distal ends of the two pull wires are angled and spaced apart from each other. The proximal end of each pull wire is operatively connected to a respective adjustment knob on the handle to adjust the tension of the pull wire. Thus, applying tension to both pull wires allows the manipulable section to bend in a first plane (e.g., bend rearward toward the handle), but increasing the tension of one of the pull wires while releasing the tension of the other pull wire allows the manipulable section to bend in a second plane that crosses the first plane (e.g., bend laterally).

[0035] One problem with many delivery devices having a dual pull wire is that each pull wire must be adjusted independently in order to bend the steerable section in a desired direction. For example, in order to bend the steerable section in a first plane, it can be difficult to ensure that equal tension is applied to both pull wires. In order to bend the steerable section in a second plane, an increase in tension in one pull wire cannot be appropriately offset by a decrease in tension in the other pull wire. Thus, the steering accuracy of the delivery device can be difficult to control. Further, having independent adjustment mechanisms for the two pull wires can increase the complexity and dimensional profile of the delivery device. Therefore, there is a need for a delivery device with improved design and maneuverability.

[0036] Referring to FIG. 1, delivery instrument 10, according to one embodiment, includes a handle 12 and a shaft 14 extending distally from the handle. Shaft 14 has a proximal portion 16 and a distal portion 18. The proximal portion 16 of shaft 14 can be coupled to handle 12. Handle 12 can be configured to position and / or operate shaft 14 as further described below.

[0037] Although not shown, the delivery appliance 10 may include one or more catheters that are coaxially disposed within and / or surround the shaft 14 and are movable relative thereto. For example, the delivery appliance 10 may include an outer sheath that extends over the shaft 14 and is longitudinally movable relative to the shaft 14. The delivery appliance may also have an inner catheter configured as an implant catheter that is coaxially disposed within and movable relative to the central lumen 30 of the shaft 14, and the implant catheter may have an artificial heart valve that is balloon-expandable or self-expandable and is mounted on the distal end of the implant catheter. Exemplary configurations of the artificial heart valve and the implant catheter are further disclosed in U.S. Patent Application Publication Nos. 2013 / 0030519, 2012 / 0123529, 2010 / 0036484, 2010 / 0049313, 2010 / 0239142, 2009 / 0281619, 2008 / 0065011, and 2007 / 0005131. Further, it should be understood that the delivery appliance 10 may be used to deliver any of a variety of other implantable devices, such as docking devices, leaflet clips, etc.

[0038] Referring to FIG. 2, the shaft 14 may have a central lumen 30 surrounded by a sidewall 32. The sidewall 32 of the shaft 14 may be made of a flexible, axially non-compressible material and / or structure in some embodiments. In some embodiments, the shaft 14 can be an extruded polymer tube that is extruded to form the central lumen and the sidewall 32. In another embodiment, the sidewall 32 may include a helical coil, which is preferably a closed pitch coil and has no spacing between adjacent turns of the coil to avoid axial compression of the coil. This coil can be made of any suitable biocompatible metal, polymer, or combination thereof. The shaft may include an inner polymer layer extending over the inner surface of the coil and / or an outer polymer layer extending over the outer surface of the coil.

[0039] In an alternative embodiment, the sidewall 32 may include an elongate slotted tube (e.g., a metal tube) having a plurality of axially spaced and circumferentially extending slots formed along the length of the tube (e.g., by laser cutting). An exemplary configuration of the slotted tube is described in U.S. Patent Application Publication No. 2015 / 0305865.

[0040] In another example, the sidewall 32 may include a polymeric tube reinforced with a braided metal layer, such as a polyimide tube reinforced with a braided stainless steel layer. In some embodiments, an inner polymeric layer may be fixed to the inner surface of the braided layer and / or an outer polymeric layer may be fixed to the outer surface of the braided layer.

[0041] As shown in FIGS. 2 and 3A - 3B, the shaft 14 may further include a plurality of pull wires 20, 22 disposed within and longitudinally extending through respective pull wire conduits 24, 26 formed in the sidewall 32. The pull wires 20, 22 may be used to control and / or manipulate the curvature of the distal portion 18 of the shaft 14. The pull wire conduits 24, 26 can extend at least partially through the proximal portion 16 and the distal portion 18 of the shaft 14.

[0042] As shown in FIGS. 3A - 3B, the pull wire conduits 24, 26 may be disposed eccentrically with respect to the central lumen 30 and circumferentially spaced from each other at the distal portion 18 of the shaft 14.

[0043] In some embodiments, the pull wire conduits 24, 26 are spatially separated from each other over the entire length of the shaft 14. Alternatively, the pull wire conduits 24, 26 may be joined to each other at the proximal portion 16 of the shaft 14 but can branch apart separately at the distal portion 18 of the shaft 14. In other words, the pull wires 20, 22 share the same lumen along the proximal portion 16 of the shaft 14 but can extend through separate longitudinally extending pull wire conduits 24, 26 at the distal portion 18 of the shaft 14.

[0044] In other embodiments, the pull wire conduits 24, 26 may have openings on the sidewall 32 of the shaft 14 near the proximal portion 16, such that the proximal portions of the pull wires 20, 22 can extend outside the shaft 14 through such openings before being connected to the steering mechanism 38 located inside the handle 12. Other configurations of the pull wire conduits are described in U.S. Patent Application Publication No. 2016 / 0158497. Regardless of the configuration of the pull wire conduits 24, 26 in the proximal portion 16, the pull wire conduits 24, 26 can be substantially parallel to each other along the distal portion 18 of the shaft 14.

[0045] In some embodiments, the central lumen 30 and / or the pull wire conduits 24, 26 may have a low friction and / or flexible liner (not shown) covering the inner surface of the lumen / conduit, and the liner may include polytetrafluoroethylene (PTFE), ultra-high molecular weight polyethylene (UHMWPE), or another suitable material.

[0046] The proximal end 20a of the first pull wire 20 and the proximal end 22a of the second pull wire 22 can be connected to the steering mechanism 38 of the handle 12. As will be more fully described below, the steering mechanism 38 can be configured to selectively increase and / or decrease the tension of the pull wires 20, 22 to adjust, for example, the curvature of the distal portion 18 of the shaft 14.

[0047] In some embodiments, the distal portion 18 of the shaft 14 may be constructed of a relatively more flexible material than the proximal portion 16 of the shaft 14 and / or alternatively may be constructed to be relatively more flexible than the proximal portion 16 of the shaft 14, such that the curvature of the proximal portion 16 may remain substantially unchanged when the curvature of the distal portion 18 is adjusted by applying tension by the pull wires 20, 22, as further described below. Further details regarding the construction of the shaft 14, the handle 12, and / or the adjustment of the tension of the pull wires are described in U.S. Patent Application Publication Nos. 2013 / 0030519, 2009 / 0281619, 2008 / 0065011, and 2007 / 0005131.

[0048] Referring to FIG. 2, the distal end 28 of the shaft 14 may be formed as a low durometer atraumatic tip, which may be radiopaque in certain embodiments. The distal end 20b of the first pull wire 20 and the distal end 22b of the second pull wire 22 may be coupled to the distal portion 18 of the shaft 14. In certain embodiments, the distal end 20b of the first pull wire 20 and the distal end 22b of the second pull wire 22 may be coupled at the same or at least substantially the same axial location at the distal end 28 of the shaft 14. For example, in some embodiments, the distal ends 20b, 22b of the pull wires 20, 22 may be fixedly secured to a pull ring 34 adjacent and proximal to the distal end 28 of the shaft 14. The pull ring 34, which may be coaxial with the distal portion 18 of the shaft 14, may be embedded or otherwise secured to the shaft 14 at or adjacent to the distal ends of the pull wire conduits 24, 26.

[0049] FIGS. 3A-3B show exemplary embodiments of positioning the pull wire conduits 24, 26 (and thus the pull wires 20, 22) at an angle along the distal portion 18 of the shaft 14. In the illustrated embodiments, the pull wire conduits 24, 26 are disposed within the side wall 32 of the shaft 14. In other embodiments, the pull wire conduits 24, 26 may have different locations, for example, adjacent to the inner or outer surface of the side wall 32.

[0050] Along the distal portion 18 of the shaft 14, the first pull wire conduit 24 can be positioned along a first axis B1 that extends radially from the central axis 36 of the shaft 14 to the first pull wire conduit 24. The second pull wire conduit 26 can be positioned along a second axis B2 that extends radially from the central axis 36 of the shaft 14 to the second pull wire conduit 26. As shown, the pull wire conduits 24, 26 can be angularly separated from each other by an angle (α) between the axis B1 and the axis B2.

[0051] In the embodiment depicted in FIG. 3A, the angle α can be about 180° (i.e., the distal ends 20b, 22b of the pull wires 20, 22 are diametrically opposed to each other with respect to the central axis 36).

[0052] In other embodiments depicted in FIG. 3B, the angle α can be any angle greater than 0° and less than 180°. In some embodiments, the angle α can be about 90° to about 150°. In the illustrated embodiment, the angle α is about 120°.

[0053] As will be more fully described below, with a dual wire configuration as depicted in FIGS. 3A - 3B, the distal portion 18 of the shaft 14 can be bent in various directions on multiple planes within a three - dimensional (3D) space to accurately and conveniently position and align the distal end 28 (and the atraumatic tip) of the shaft 14.

[0054] Referring to FIGS. 4 - 5, the operation of the steering mechanism 38 is shown. As described above, the proximal ends 20a, 22a of the pull wires 20, 22 can be coupled to the steering mechanism 38. In some embodiments, the steering mechanism can be disposed inside the handle 12.

[0055] The control mechanism 38 may include a first spool or wheel 40 and a second spool or wheel 42 connected by a mandrel 46. Specifically, the first wheel 40 and the second wheel 42 may be operatively connected by a differential mechanism 44 located on the mandrel 46.

[0056] The differential mechanism 44 may include a drive shaft, a first output shaft, a second output shaft, and a gear train connecting the drive shaft to the first and second output shafts. The differential mechanism 44 may, for example, enable the first and second output shafts to rotate together and / or individually. The differential mechanism 44 may, for example, enable the first and second output shafts to rotate together in the same direction and / or in opposite directions relative to each other. The differential mechanism 44 may be constructed and / or implemented by various means and may be either passive or active. For example, in some embodiments, the differential mechanism 44 may be an open differential, a locking (e.g., selectively lockable) differential, or a limited slip differential. As described herein, all known differentials may be used in the control mechanism 38 and are considered to be within the scope of the present disclosure.

[0057] In a particular embodiment, the first output shaft of the differential mechanism 44 may be connected to the first wheel 40, and the second output shaft of the differential mechanism 44 may be connected to the second wheel 42. Accordingly, the control mechanism 38 can adjust the tension of the first pull wire 20 and the second pull wire 22 by selectively rotating the first wheel 40 and the second wheel 42.

[0058] As shown in FIG. 4, the proximal end 20a of the first pull wire 20 can be connected to the first wheel 40, and the proximal end 22a of the second pull wire 22 can be connected to the second wheel 42. The first pull wire 20 and the second pull wire 22 can be wound or wrapped around the first wheel 40 and the second wheel 42, respectively. In the illustrated embodiment, the pull wires 20, 22 are generally wound or wrapped in the same direction, for example, clockwise or counterclockwise.

[0059] In the first operating mode, generally equal tension can be applied to both pull wires 20, 22 by rotating both wheels 40, 42 in the same direction. This can be achieved, for example, by rotating the drive shaft of the differential mechanism 44. In certain embodiments, a locking differential and / or a limited slip differential can help maintain equal tension in both pull wires by ensuring that both wheels 40, 42 rotate together in the same direction as the drive shaft rotates.

[0060] For example, as shown in FIG. 4, when both the first wheel 40 and the second wheel 42 are rotated in a first rotational direction D1 (e.g., clockwise), the pull wires 20, 22 are wound around the wheels 40, 42, and the tension in the pull wires 20, 22 can be increased. Thereby, the distal portion 18 of the shaft 14 can curve in a first angular direction U within the first plane P1, as shown in FIGS. 3A - 3B.

[0061] Conversely, when both the first wheel 40 and the second wheel 42 are rotated in a second rotational direction D2 opposite to the first rotational direction D1 (e.g., counterclockwise), the pull wires 20, 22 are unwound from the wheels 40, 42, and the tension in the pull wires 20, 22 can be decreased. Thereby, the distal portion 18 of the shaft 14 can return to the stationary configuration of the shaft 14 by curving in a second angular direction D opposite to the first angular direction U within the first plane P1, as shown in FIGS. 3A - 3B.

[0062] Instead of, or in addition to, simultaneously adjusting the tensions of the pull wires 20, 22 by rotating both the first wheel 40 and the second wheel 42 in the same direction, the tensions of the pull wires 20, 22 can be adjusted simultaneously by translating the steering mechanism 38 longitudinally relative to the shaft 14. For example, the drive shaft of the differential mechanism 44 and / or an independent drive shaft connected to the mandrel 46 can be configured to translate (e.g., slide) the mandrel 46 distally and / or proximally relative to the shaft 14. Since the first wheel 40 and the second wheel 42 are connected by the mandrel 46, movement of the mandrel 46 distally or proximally causes corresponding movement of the wheels 40, 42 distally or proximally. Since the proximal ends 20a, 22a of the pull wires 20, 22 are connected to the wheels 40, 42, proximal movement of the wheels 40, 42 relative to the shaft 14 (e.g., longitudinal movement in the direction indicated by arrow D1 shown in FIG. 4) can increase the tension of the pull wires 20, 22, while distal movement of the wheels 40, 42 relative to the shaft (e.g., longitudinal movement in the direction indicated by arrow D2 in FIG. 4) can decrease the tension of the pull wires 20, 22.

[0063] As described above, the conduits 24, 26 can be substantially parallel to each other along the distal portion 18 of the shaft 14. Thus, the first pull wire 20 and the second pull wire 22 in the distal portion 18 can be substantially parallel to each other, whereby they can define a second plane P2.

[0064] In the embodiment depicted in FIG. 3A, where the distal ends 20b, 22b of the pull wires 20, 22 face each other diametrically with respect to the central axis 36, the second plane P2 can intersect the first plane P1 at the central axis 36. Further, the second plane P2 can be substantially perpendicular to the first plane P1.

[0065] The distal portion 18 of the shaft 14 may have a biasing structure that allows the distal portion 18 to curve in a first angular direction U when tension is applied to both pull wires 20, 22. For example, the sidewall area of the distal portion 18 facing the first angular direction U may have a lower durometer than the opposite (i.e., the sidewall area facing the second angular direction D) sidewall area. Various structures may be utilized to achieve such a durometer difference. For example, the opposing sidewalls of the distal portion 18 may be constructed by using different materials, or different densities, or different structures (e.g., the distal portion 18 may have a slotted tube portion where the slots are located on the sidewall area facing the first angular direction U) of the same material, or any combination thereof.

[0066] In the embodiment depicted in FIG. 3B, where the distal ends 20b, 22b of the pull wires 20, 22 are angled away from each other by an angle less than 180°, the second plane P2 may intersect the first plane P1 at a location eccentric with respect to the central axis 36. Further, the second plane P2 may be substantially perpendicular to the first plane P1.

[0067] The distal portion 18 of the shaft 14 may have a unique bias to curve in the first angular direction U when tension is applied to both pull wires 20, 22. Since the distal ends 20b, 22b of the pull wires 20, 22 are arranged on the same side of the central axis 36 along the first angular direction U, applying tension to both pull wires 20, 22 may generate a bending force away from the central axis 36 in the first angular direction U.

[0068] In certain embodiments, the distal portion 18 can be linear when in a neutral or rest configuration. Increasing the tension in both pull wires 20, 22 causes the distal portion 18 of shaft 14 to bend in a first angular direction U, thereby moving the distal end 28 of shaft 14 slightly proximally toward handle 12. On the other hand, releasing the tension in pull wires 20, 22 causes the distal portion 18 to straighten in a second angular direction D, and the distal end 28 of shaft 14 can be moved slightly distally away from handle 12.

[0069] In an alternative embodiment (not shown), the distal portion 18 can be pre-curved (e.g., curved in direction D) when in the neutral configuration. In such an embodiment, increasing the tension in both pull wires 20, 22 causes the distal portion 18 to straighten and / or bend in direction U, while decreasing the tension causes the distal portion 18 of shaft 14 to return to its pre-curved neutral configuration (e.g., curved in direction D).

[0070] In a second mode of operation, tension can be applied to only one of pull wires 20, 22 while the tension in the other pull wire is decreased. This can be accomplished, for example, by rotating wheels 40, 42 in opposite directions such that one pull wire is wound while the other is unwound. As a result, the distal portion 18 of shaft 14 can curve away from the first plane P1.

[0071] For example, as shown in FIG. 5, rotating only the first wheel 40 in a first rotational direction D1 (e.g., clockwise) by differential mechanism 44 can cause the second wheel 42 to rotate simultaneously in a second rotational direction D2 (e.g., counterclockwise) opposite the first rotational direction D1. This can increase the tension in the first pull wire 20 and decrease the tension in the second pull wire 22. As a result, the distal portion 18 of shaft 14 can curve away from the first plane P1 in a first angular direction L (see, e.g., FIGS. 3A - 3B).

[0072] Conversely, if only the second wheel 42 is rotated in the first rotational direction D1 (e.g., clockwise), the first wheel 40 can rotate simultaneously in the second rotational direction D2 (e.g., counterclockwise). As a result, the tension of the first pull wire 20 can decrease and the tension of the second pull wire 22 can increase. Consequently, the distal portion 18 of the shaft 14 can curve away from the first plane P1 in the second angular direction R (see, e.g., FIGS. 3A - 3B). The second angular direction R can be generally opposite to the first angular direction L.

[0073] In the embodiment depicted in FIG. 3A, where the distal ends 20b, 22b of the pull wires 20, 22 face each other diametrically with respect to the central axis 36, when the wheels 40, 42 are rotated in opposite directions respectively, the distal portion 18 of the shaft 14 can curve within a second plane P2 perpendicular to the first plane P1. In other words, the first angular direction L and the second angular direction R can be within the second plane P2 and point in opposite directions (e.g., left and right respectively in FIG. 3A) away from the central axis 36.

[0074] In the embodiment depicted in FIG. 3B, where the distal ends 20b, 22b of the pull wires 20, 22 are angled away from each other by an angle less than 180°, when the wheels 40, 42 are rotated in opposite directions respectively, due to the eccentricity of the pull wires 20, 22 with respect to the central axis 36, the distal portion 18 of the shaft 14 can curve non - vertically away from the first plane P1.

[0075] For example, the first angular direction L can be decomposed into a first component L1 (e.g., upward in FIG. 3B) in the first plane P1 and a second component L2 (e.g., leftward in FIG. 3B) in the second plane P2. Similarly, the second angular direction R can be decomposed into a first component R1 (e.g., upward in FIG. 3B) in the first plane P1 and a second component R2 (e.g., rightward in FIG. 3B) in the second plane P2. The second components L2 and R2 are within the second plane P2 and point in opposite directions (e.g., left and right respectively in FIG. 3B) away from the central axis 36, and the first components L1 and R1 are away from the second plane P2 and point in the same direction (e.g., upward in FIG. 3B).

[0076] In certain embodiments, the distal portion 18 of the shaft 14 can be linear when in a neutral or stationary configuration. Increasing the tension of only one of the pull wires while decreasing the tension of the other pull wire can cause the distal portion 18 to curve away from the first plane P1 in one angular direction (e.g., L or R). Reversing the tension application and / or release of the pull wires can enable the distal portion 18 of the shaft 14 to return to its linear configuration and / or curve away from the first plane P1 in the opposite angular direction.

[0077] In an alternative embodiment (not shown), the distal portion 18 can be pre-curved (e.g., curved in the direction L or R) when in a neutral configuration. Increasing the tension of only one of the pull wires while decreasing the tension of the other pull wire can cause the distal portion 18 to bend in the opposite angular direction (e.g., R or L), straighten the distal portion 18, or bend it away from its neutral, pre-curved configuration in the opposite direction. Reversing the tension application and / or release of the pull wires can enable the distal portion 18 to return to its pre-curved configuration and / or bend beyond its neutral, pre-curved configuration.

[0078] The delivery device 10 may include an operating mechanism 48, which may be positioned on the handle 12 and operably coupled to the steering mechanism 38. The operating mechanism 48 may be operated in a plurality of operating modes. For example, when the operating mechanism 48 is operated in the first operating mode, both wheels 40, 42 rotate in the same direction, and the distal portion 18 of the shaft 14 can curve within the first plane P1. When the operating mechanism 48 is operated in the second operating mode, the wheels 40, 42 rotate in opposite directions relative to each other, and the distal portion 18 of the shaft 14 can curve away from the first plane P1.

[0079] In the exemplary embodiment depicted in FIG. 1, the operating mechanism 48 includes a first operating mechanism 50 and a second operating mechanism 52. The first operating mechanism 50 may be operably coupled to the steering mechanism 38, whereby, when the first operating mechanism 50 is operated, both the first wheel 40 and the second wheel 42 can selectively rotate in either the first or second rotational direction (i.e., D1 or D2). The second operating mechanism 52 may be operably coupled to the steering mechanism 38, whereby, when the second operating mechanism 52 is operated, only one of the wheels 40, 42 can selectively rotate in the first rotational direction D1, and as a result, the other wheel rotates simultaneously in the second rotational direction D2.

[0080] The user interfaces of the first operating mechanism 50 and the second operating mechanism 52 can take the form of rotatable knobs as depicted in FIG. 1. For example, a clockwise (or counterclockwise) rotation of the first operating mechanism 50 can simultaneously increase the tension of both pull wires 20, 22, while a counterclockwise (or clockwise) rotation of the knob can simultaneously decrease the tension of both pull wires 20, 22. In another example, a clockwise (or counterclockwise) rotation of the second operating mechanism 52 can increase the tension of the pull wire 20 while decreasing the tension of the pull wire 22, while a counterclockwise (or clockwise) rotation of the knob can increase the tension of the pull wire 22 while decreasing the tension of the pull wire 20.

[0081] However, it should be understood that the user interface of the actuating mechanism 48 can take any other form, such as a push button, an operating lever, a voice-controlled actuator, etc. Although the embodiment depicted in FIG. 1 shows two independent rotatable knobs, it should be understood that the user interface of the actuating mechanism 48 can be integrated into a single unit or, alternatively, can include a set of three or more units. In one exemplary, non-limiting embodiment (not shown), the user interface of the actuating mechanism 48 can include four buttons, namely, a first button configured to increase the tension of both pull wires 20, 22, a second button configured to decrease the tension of both pull wires 20, 22, a third button configured to increase the tension of pull wire 20 and decrease the tension of pull wire 22, and a fourth button configured to increase the tension of pull wire 22 and decrease the tension of pull wire 20.

[0082] Although not shown, it should be understood that the operative connection between the actuating mechanism 48 and the steering mechanism 38 can also take various forms. For example, a first actuating mechanism 50 can be connected to the steering mechanism 38 by a drive shaft of the differential mechanism 44. When the first actuating mechanism 50 is actuated, the drive shaft and the drive gear inside the differential mechanism 44 can rotate, thus causing the first and second output shafts to rotate clockwise or counterclockwise. As a result, both wheels 40, 42 can rotate in the same direction as the first and second output shafts, and the tension of both pull wires 20, 22 can be increased or decreased. Alternatively, the first actuating mechanism 50 can directly increase or decrease the tension of both pull wires 20, 22 by simultaneously winding or unwinding pull wires around the respective wheels 40, 42. A second actuating mechanism 52 can be connected to the steering mechanism 38 such that it can selectively drive only one of the output shafts and / or wheels 40, 42. For example, the second actuating mechanism 52 can be configured to drive only one wheel in one rotational direction (D1 or D2) and cause the other wheel to rotate in the opposite direction by the differential mechanism 44.

[0083] In some embodiments, the delivery instrument 10 may further include at least two sensors (not shown) that measure the tensile forces of the pull wires 20, 22, respectively. Those sensors may be operatively coupled to one or more indicators (not shown) positioned on the handle 12. The indicators can take various forms, such as a needle indicator, an LED light, a digital display, and the like. Such indicators can be used to provide the operator with perceptible feedback and information regarding the tension of each pull wire measured by each sensor. Thus, the operator can accurately control the bending of the distal portion 18 of the shaft 14 by adjusting the tension of each pull wire through the actuating mechanism 48.

[0084] General Introduction It should be understood that the disclosed embodiments may be adapted to deliver an artificial device for implantation into any of the native valve annuli of the heart (e.g., the pulmonary valve annulus, the mitral valve annulus, and the tricuspid valve annulus) and may be used with any of a variety of delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.).

[0085] For the purposes of this description, certain aspects, advantages, and novel features of embodiments of the present disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various embodiments disclosed, alone and in various combinations and sub-combinations with each other. The methods, apparatuses, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments need not have any one or more particular advantages or solve any particular problems. The technology from any example can be combined with the technology described in any one or more of the other examples. In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be understood as limiting the scope of the disclosed technology.

[0086] Some of the operations of the disclosed embodiments are described in a particular order for the convenience of presentation, but this manner of description encompasses permutations unless a particular ordering is required by the specific words used hereinafter. For example, operations described consecutively may, in some cases, be permuted or may be performed simultaneously. Further, for simplicity, the accompanying drawings may not show the various ways in which the disclosed method may be used in conjunction with other methods. Further, in the description, terms such as "provide" or "achieve" may be used to describe the disclosed method. These terms are high-level abstract concepts of the actual operations being performed. The actual operations corresponding to these terms may vary depending on the particular implementation and may be readily discernible by one of ordinary skill in the art.

[0087] As used in this application and the claims, the singular forms "a", "an", and "the" include the plural unless the context clearly dictates otherwise. Further, the term "includes" means "comprises". Further, the terms "coupled" and "connected" generally mean being coupled or linked electrically, electromagnetically, and / or physically (e.g., mechanically or chemically), and do not exclude the existence of intermediate elements between the items being coupled or associated, unless the contrary is stated.

[0088] Directions and other relative designations (e.g., inside, outside, etc.) may be used to facilitate discussion of the principles in the drawings and this specification, but are not intended to be limiting. For example, specific terms such as "inside", "outside", "interior", "exterior", etc. may be used. Such terms are used, where applicable, to somewhat clarify the description when discussing relative relationships, particularly with respect to the illustrated embodiments. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. As used herein, "and / or" means "and" or "or", as well as "and" and "or".

[0089] In view of the many possible embodiments to which the principles of the present disclosure may be applied, it should be recognized that the illustrated embodiments are merely examples and should not be understood as limiting the scope of the claimed subject matter. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

[0090] The following inventions are also presented in this application. [Item 1] A shaft including a proximal portion and a distal portion, A first pull wire having a proximal end and a distal end, wherein the distal end of the first pull wire is coupled to the distal portion of the shaft, the first pull wire A second pull wire having a proximal end and a distal end, wherein the distal end of the second pull wire is connected to the distal portion of the shaft, the second pull wire; A handle connected to the proximal portion of the shaft and including a steering mechanism, the steering mechanism including a first wheel and a second wheel operatively connected by a differential mechanism, the handle, wherein the proximal end of the first pull wire is connected to the first wheel, and the proximal end of the second pull wire is connected to the second wheel, When both the first and second wheels are rotated in a first rotational direction, the tension in the first and second pull wires is increased, whereby the distal portion of the shaft curves in a first angular direction within a first plane, When only the first wheel is rotated in the first rotational direction, the second wheel rotates in a second rotational direction opposite to the first rotational direction, the tension in the first pull wire is increased, and the tension in the second pull wire is decreased, whereby the distal portion of the shaft curves in a second angular direction away from the first plane, a steerable medical instrument. [Item 2] When both the first and second wheels are rotated in the second rotational direction, the tension in the first and second pull wires is decreased, whereby the distal portion of the shaft curves in a third angular direction opposite to the first angular direction within the first plane, the instrument according to Item 1. [Item 3] When only the second wheel is rotated in the first rotational direction, the first wheel rotates in the second rotational direction, the tension in the second pull wire is increased, and the tension in the first pull wire is decreased, whereby the distal portion of the shaft curves in a fourth angular direction away from the first plane and opposite to the second angular direction, the instrument according to Item 1 or 2. [Item 4] The distal ends of the first and second pull wires are spaced apart from each other at an angle of 180°, the instrument according to any one of Items 1 to 3. [Item 5] The instrument according to item 4, wherein the second angular direction and the fourth angular direction are in a second plane substantially perpendicular to the first plane. [Item 6] The instrument according to any one of items 1 to 5, wherein the distal end portions of the first pull wire and the second pull wire are spaced apart from the distal end portion of the shaft by an equal distance. [Item 7] Further including a first pull wire conduit and a second pull wire conduit, each of which extends at least partially through the proximal portion and the distal portion of the shaft, the first pull wire extending through the first pull wire conduit, and the second pull wire extending through the second pull wire conduit. The instrument according to any one of items 1 to 6. [Item 8] The handle includes a first actuating mechanism operatively connected to the steering mechanism, whereby when the first actuating mechanism is actuated, both the first and second wheels can selectively rotate in the first or second rotational direction. The instrument according to any one of items 1 to 7. [Item 9] The handle includes a second actuating mechanism operatively connected to the steering mechanism, whereby when the second actuating mechanism is actuated, only the first or second wheel can selectively rotate in the first rotational direction. The instrument according to any one of items 1 to 8. [Item 10] The distal end portions of the first pull wire and the second pull wire are angled relative to the longitudinal axis of the shaft and spaced apart from each other by an angle greater than 0° and less than 180°. The instrument according to any one of items 1 to 9. [Item 11] A shaft including a proximal portion and a distal portion, A first pull wire having a proximal end portion and a distal end portion, wherein the distal end portion of the first pull wire is connected to the distal portion of the shaft. A first pull wire, A second pull wire having a proximal end and a distal end, wherein the distal end of the second pull wire is connected to the distal portion of the shaft, the second pull wire A steering mechanism including a first wheel and a second wheel operatively connected by a differential mechanism, wherein the proximal end of the first pull wire is connected to the first wheel and the proximal end of the second pull wire is connected to the second wheel, the steering mechanism An actuating mechanism operably connected to the steering mechanism, and When the actuating mechanism is operated in a first operating mode, the first and second wheels rotate in the same direction and the distal portion of the shaft curves in a first plane, When the actuating mechanism is operated in a second operating mode, the first and second wheels rotate in opposite directions and the distal portion of the shaft curves away from the first plane, a steerable medical instrument. [Claim 12] When both the first and second wheels are rotated in a first rotational direction, the tension in the first and second pull wires is increased, whereby the distal portion of the shaft curves in a first angular direction in the first plane, the instrument according to claim 11. [Claim 13] When both the first and second wheels are rotated in a second rotational direction opposite to the first rotational direction, the tension in the first and second pull wires is decreased, whereby the distal portion of the shaft curves in a second angular direction opposite to the first angular direction in the first plane, the instrument according to claim 12. [Claim 14] When only the first wheel is rotated in a first rotational direction, the second wheel rotates in a second rotational direction opposite to the first rotational direction, the tension in the first pull wire is increased, and the tension in the second pull wire is decreased, whereby the distal portion of the shaft curves in a first angular direction away from the first plane, the instrument according to claim 11. [Claim 15] When only the second wheel is rotated in the first rotational direction, the first wheel rotates in the second rotational direction, the tension of the second pull wire is increased, and the tension of the first pull wire is decreased. As a result, the distal portion of the shaft curves away from the first plane in a second angular direction opposite to the first angular direction. The instrument according to claim 14. [Claim 16] The distal end of the first pull wire and the distal end of the second pull wire are spaced apart from the distal end of the shaft by an equal distance. The instrument according to any one of claims 11 to 15. [Claim 17] Further including a first pull wire conduit and a second pull wire conduit, each of which extends at least partially through the proximal portion and the distal portion of the shaft. The first pull wire extends through the first pull wire conduit, and the second pull wire extends through the second pull wire conduit. The instrument according to any one of claims 11 to 16. [Claim 18] The distal end of the first pull wire and the distal end of the second pull wire are angled with respect to the longitudinal axis of the shaft and spaced apart from each other by an angle that is greater than 0° and less than 180°. The instrument according to any one of claims 11 to 17. [Claim 19] The distal end of the first pull wire and the distal end of the second pull wire are angled 180° and spaced apart from each other. The instrument according to any one of claims 11 to 17. [Claim 20] When the actuating mechanism is operated in the second operating mode, the distal portion of the shaft curves in a second plane perpendicular to the first plane. The instrument according to claim 19. [Claim 21] A method of maneuvering a delivery instrument within a subject's vasculature, Actuating a differential mechanism of the delivery instrument to curve a distal portion of a shaft of the delivery instrument within a first plane; A method comprising the step of actuating the differential mechanism to curve the distal portion of the shaft away from the first plane. [Item 22] The method according to item 21, wherein the differential mechanism operably couples a first wheel and a second wheel, the first wheel is coupled to a first pull wire, and the second wheel is coupled to a second pull wire. [Item 23] The act of actuating the differential mechanism to curve the distal portion of the shaft of the delivery instrument within the first plane includes rotating both the first and second wheels in a first rotational direction to increase the tension of the first and second pull wires, thereby causing the distal portion of the shaft to curve in a first angular direction within the first plane, the method according to item 22. [Item 24] The act of actuating the differential mechanism to curve the distal portion of the shaft of the delivery instrument within the first plane further includes rotating both the first and second wheels in a second rotational direction opposite to the first rotational direction to decrease the tension of the first and second pull wires, thereby causing the distal portion of the shaft to curve in a second angular direction opposite to the first angular direction within the first plane, the method according to item 23. [Item 25] The act of actuating the differential mechanism to curve the distal portion of the shaft away from the first plane includes rotating only the first wheel in a first rotational direction and rotating the second wheel in a second rotational direction opposite to the first rotational direction, thereby increasing the tension of the first pull wire and decreasing the tension of the second pull wire, thereby causing the distal portion of the shaft to curve away from the first plane in a first angular direction, the method according to item 22. [Item 26] The act of operating the differential mechanism to curve the distal portion of the shaft away from the first plane further includes the step of rotating only the second wheel in the first rotational direction and rotating the first wheel in the second rotational direction, thereby increasing the tension of the second pull wire and decreasing the tension of the first pull wire, so that the distal portion of the shaft curves away from the first plane and in a second angular direction, according to the method of claim 25. [Claim 27] The act of operating the differential mechanism to curve the distal portion of the shaft away from the first plane curves the distal portion of the shaft within a second plane perpendicular to the first plane, according to the method of any one of claims 22 to 26.

Explanation of Signs

[0091] 10 Delivery instrument 12 Handle 14 Shaft 16 Proximal portion 18 Distal portion 20 Pull wire 20a Proximal end 20b Distal end 22 Pull wire 22a Proximal end 22b Distal end 24 Pull wire conduit 26 Pull wire conduit 28 Distal end 30 Central lumen 32 Side wall 34 Pull ring 36 Central axis 38 Steering mechanism 40 First wheel 42 Second wheel 44 Differential mechanism 46 Mandrel 48 Actuating mechanism 50 First actuating mechanism 52 Second actuating mechanism B1 First axis B2 Second axis D Second angular direction D1 First rotational direction D2 Second rotational direction L First angular direction L1 First component L2 Second component P1 First plane P2 Second plane R Second angular direction R1 First component R2 Second component U First angular direction

Claims

【Claim 1】 An article substantially described as above with respect to any one of the examples or any one of the attached drawings.

Images