Multi-directional maneuverable handle for operating catheters

Abstract

This application relates to a multi-directional maneuverable handle for manipulating a catheter. The document discloses a control handle and catheter assembly for a maneuverable catheter, the catheter assembly including a traction wire and direction and magnitude controls on the handle, such that adjustment of the direction and magnitude controls adjusts the direction and degree of catheter bending, thereby manipulating the catheter according to operator commands.

Description

[0001] This application is a divisional application. The original application was filed on September 18, 2018, with application number 201880068151.7 and invention title "Multidirectional operable handle for manipulating catheters".

[0002] Related applications

[0003] U.S. non-provisional application No. 15 / 453,735, filed May 8, 2017, and U.S. provisional patent application No. 62 / 311,031, filed March 21, 2016, are incorporated herein by reference in their entirety. Technical Field

[0004] This disclosure relates to a maneuverable catheter assembly for maneuvering an attached catheter or other transluminal device. Background Technology

[0005] Transvascular techniques have been developed to introduce and implant prosthetic devices, such as heart valves, into patients using flexible transvascular catheters in a less invasive manner than open cardiac surgery. Typical catheter control systems allow only limited bending of the distal end of the catheter, such as along two orthogonal axes perpendicular to the catheter's longitudinal axis. For example, a conventional catheter control handle may include a lever or dial coupled to a traction wire extending along one side of the catheter, causing the lever or dial to be actuate and cause the distal tip of the catheter to bend radially toward one side of the longitudinal axis. To bend the distal tip in other directions, it is generally necessary to actuate other levers / dials coupled to other traction wires. Therefore, multiple actuations must generally be actuated simultaneously in a carefully combined or sequential manner to produce the desired degree of radial bending in the desired circumferential direction. In this way, control of the magnitude and direction of catheter bending is integrated, making it potentially difficult to control and not intuitively understandable. Summary of the Invention

[0006] This article discloses a maneuverable catheter assembly that utilizes various mechanisms to achieve independent control over the magnitude and direction of catheter bending, thereby improving the maneuverability of the attached catheter. The mechanism, which independently determines the circumferential angle and magnitude of catheter bending, provides the user with more direct, intuitive, and precise control over catheter manipulation.

[0007] Some disclosed embodiments utilize a cam-based system to achieve this independent control. Some cam-based embodiments utilize axially movable sliders as cam followers that ride along an inclined cam surface to control the tension in the pull wires. Other embodiments utilize ball-and-socket followers and protrusions that determine the position of the socket, which in turn control the tension in the pull wires. Other embodiments utilize a gimbal follower mechanism and protrusions that determine the positioning of the gimbal plate within the gimbal mechanism, which in turn control the tension in the pull wires. Other embodiments utilize a protrusion and a follower plate that is suspended in a control handle by at least one wire and attached to the pull wires, such that the position of the plate determines the tension in the pull wires. Still other embodiments utilize a protrusion and a follower plate that is connected to a deformable ball and the pull wires, such that the position of the plate determines the tension in the pull wires. A further embodiment utilizes a protrusion and a plate attached to a ball, wherein the ball engages with and can rotate within a socket base fixed to a control handle, allowing the plate to tilt in multiple directions in response to movement of the protrusion. The plate is also attached to a traction wire, such that the position of the plate determines the tension in the catheter traction wire. A further embodiment includes a double-threaded nut, a reverse-threaded follower engaging with and connected to the catheter traction wire, and a drive member, such that the position of the follower determines the tension in the catheter traction wire. The operable catheter assembly of this disclosure allows independent control of the magnitude of the flexure and the circumferential angle at which the flexure occurs while the entire catheter remains stationary within the patient's body. In an alternative embodiment, the operable catheter assembly includes a pair of opposing followers connected to the traction wire, wherein the followers are driven in opposite directions by the movement of corresponding planetary gears, thereby controlling the tension in the traction wire.

[0008] It may also include a clutch mechanism to fix the circumferential angle at which the bending occurs, while continuously allowing adjustment of the bending magnitude. The clutch mechanism can also be used to fix the bending magnitude while continuously allowing adjustment of the circumferential angle at which the bending occurs. Rack and pinion assemblies and pulley assemblies may be included in the embodiment to provide mechanical benefits when tension is applied to the traction wire, amplifying the motion.

[0009] In the embodiments disclosed herein, the operable conduit assembly may include a handle, which may also include a housing having longitudinal axes extending in distal and proximal directions. The handle may further include a flexmagnitude control, adjustment of which causes axial adjustment of one or more followers relative to the housing. The flexmagnitude control may be fixed relative to a central axis extending axially through or about a cam member and may be rotatably engaged with the housing as a knob to allow rotation of the flexmagnitude control and the central axis relative to the housing while limiting axial movement of the flexmagnitude knob and the central axis relative to the housing. The central axis may engage with one or more followers such that adjustment of the flexmagnitude control relative to the housing causes axial movement of the cam member relative to the housing. Alternatively, any other suitable means of independently actuating the axial movement of one or more followers relative to the housing may be utilized, including digital input from a user.

[0010] The handle may further include a bending direction control, wherein adjustment of the bending direction control causes rotational adjustment of the conduit via differential axial movement of one or more followers. In some embodiments disclosed herein, the bending direction control and the bending magnitude control may be positioned adjacent to the distal end or proximal end of the handle. Alternatively, any other suitable means of independently actuating differential axial movement of one or more followers relative to the housing may be utilized, including digital input from the user.

[0011] In an embodiment of an operable guide assembly including a cam-based system, the cam member may include a contact surface at an axial end that engages with one or more followers, and this contact surface may have a slope that varies in axial position depending on the circumferential position about the longitudinal axis of the control handle. The slope of the cam member contact surface may gradually change in axial position, moving circumferentially about the contact surface, such that as the cam member rotates about the longitudinal axis of the handle, the followers (one or more) gradually move distally or proximally. The shape and slope of the cam can be changed to affect the follower's response to control input from the user (bending magnitude or circumferential angular direction). Such adjustment can be used to address the "drift" problem in cam follower control systems. The number of followers can also be increased to address "drift" and provide finer control. The cam member can have different shapes, including dwell, flats, rounds, or detents. The cam member may be further shaped as it is adjusted axially or rotationally. For example, the cam may be in the form of a metal strip that widens or narrows as it extends.

[0012] In some embodiments, each of the plurality of traction wires is coupled to its respective follower, which slides along a longitudinal groove in the handle in response to its contact position along a rotatable and axially translatable cam member. When the cam member engages with the follower, rotation of the cam member causes some followers to move distally and some followers to move proximally, causing a change in the direction of conduit bending. For followers engaging with the cam contact surface, linear translation of the cam member in the axial direction causes all sliders to slide together distally or proximally, thereby changing the degree of bending.

[0013] In some embodiments, a ball-and-socket mechanism is included, such that the socket acts as a follower and is coupled to the traction wire, wherein the socket hinges around the ball in response to contact with the cam member. Such embodiments also include protrusions whose rotation and axial translation similarly cause independent changes in the direction and degree of conduit bending.

[0014] In some implementations, the universal joint may be included in the handle to act as a driven element. A traction wire may be coupled to a plate in the universal joint, and the plate may be actuated relative to the housing in multiple dimensions—by rotation and translation of protrusions that contact the plate.

[0015] In an alternative embodiment of the invention, the operable catheter assembly includes a control handle comprising a double-threaded nut, a reverse-threaded follower engaging with the double-threaded nut and coupled to the catheter traction wire, and a drive member. User input to a bending level control on the control handle causes axial movement of the drive member, effectively affecting the position of the follower relative to the control handle axially. User input to a bending direction control on the control handle causes the follower to move relative to the handle in the opposite axial direction, thereby controlling the direction of catheter bending. The position of the follower determines the tension in the catheter traction wire.

[0016] In a further embodiment of the invention, the operable catheter assembly includes a driven member coupled to a traction wire and engaging with drive screws, wherein each pair of drive screws includes screws with opposite threads and engages with planetary gears such that rotation of the planetary gears causes the driven member to move along the screws in opposite directions, thereby controlling the tension in the traction wire.

[0017] The foregoing and other objects, features and advantages of this disclosure will become more apparent from the following detailed description with reference to the accompanying drawings. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of a maneuverable catheter assembly that includes independent magnitude and direction control of the attached catheter.

[0019] Figure 2This is a perspective view of an exemplary cam-follower controlled multi-directional control handle for a maneuverable conduit assembly.

[0020] Figure 3 yes Figure 2 Exploded perspective view of the control handle;

[0021] Figure 4 This is a perspective view of an exemplary cam structure;

[0022] Figure 4A There is a pause shape in the cam contact surface. Figure 4 A perspective view of the cam;

[0023] Figure 5-15 It is a graphical illustration of various cam and cam follower arrangements, showing the magnitude and direction of duct bending of the cam and cam follower movement for different user inputs and cam shapes;

[0024] Figures 16A-16D Exemplary implementations with different cam shapes are illustrated;

[0025] Figure 17A An example is given of a cam with three followers and the follower arrangement;

[0026] Figure 17B An example is given of a cam with two followers and the follower arrangement;

[0027] Figure 18A and Figure 18B The example illustrates that the spacing between cam followers can be non-uniform;

[0028] Figure 19 An exemplary embodiment of a cam and follower arrangement with two cams is illustrated;

[0029] Figure 20A and 20B An exemplary embodiment of the cam and follower arrangement is illustrated, wherein the size of the cam is adjustable;

[0030] Figure 21 It is a perspective view of the ball socket mechanism and protrusion that are operatively attached to a maneuverable catheter;

[0031] Figure 22 yes Figure 21 A perspective view of the ball joint mechanism and the protrusion;

[0032] Figure 23 A perspective view of an exemplary multi-directional control handle is shown, which has a cam-universal mechanism to control the traction wire of a maneuverable catheter assembly.

[0033] Figure 24A perspective view of an exemplary multi-directional control handle is shown, which has a protruding universal mechanism for controlling the traction wire of a maneuverable catheter assembly.

[0034] Figure 25-27 A perspective view of an exemplary multi-directional control handle is shown, wherein, for illustrative purposes, it has various positions. Figure 23 A cam-universal mechanism without a traction wire;

[0035] Figures 28-29 A cross-sectional view of an exemplary multi-directional control handle is shown, wherein, for illustrative purposes, it has... Figure 23 A cam-universal mechanism without a traction wire;

[0036] Figure 30-32 A perspective view of an exemplary multi-directional control handle with a cam-universal mechanism for controlling the traction wire is shown, wherein the traction wire is doubled back to provide mechanical advantages for the traction wire.

[0037] Figure 33 A perspective view of another exemplary multi-directional control handle with a cam-universal mechanism for controlling the traction wire is shown, wherein the traction wire folds back along its original path to provide mechanical advantages and a change in direction for the traction wire;

[0038] Figure 34 Showing Figure 33 A cross-sectional view of the multi-directional control handle;

[0039] Figures 35-39 The operation of the multi-directional control handle is illustrated;

[0040] Figure 40 A side view of an exemplary embodiment of a rack and pinion assembly that connects the traction wire and the universal joint assembly is shown.

[0041] Figure 41 A side view of the lever assembly is shown, which offers mechanical advantages in increasing the tension of the catheter traction wire;

[0042] Figure 42 A side view of a pulley system is shown, which can provide mechanical advantages in increasing the tension of the catheter traction wire.

[0043] Figure 43 It is a perspective view of an exemplary embodiment of a manipulable catheter assembly having a multi-directional control handle and an attached catheter.

[0044] Figure 44A This is a side view of a plate for a maneuverable catheter assembly, which has an attached ball and a traction wire in a fixed fossa mechanism.

[0045] Figure 44B yes Figure 44A The top view of the plate shown;

[0046] Figure 45A and 45B A side view shows the plate and attached deformable sphere for the maneuverable catheter assembly, as well as the attached traction wire.

[0047] Figure 46A and 46B A perspective view of a plate for a maneuverable catheter assembly is shown, suspended from the control handle housing, with attached traction wires.

[0048] Figure 47 A perspective view of an embodiment of a multi-directional control handle having a double-threaded nut, a follower, and a drive is shown;

[0049] Figure 48 Showing along Figure 47 The plane intercepted by line 48-48 in the middle Figure 47 A cross-sectional view of the multi-directional control handle;

[0050] Figure 49 Showing Figure 47 An exploded view of the control handle's drive mechanism, as well as the double-threaded nut and driven mechanism;

[0051] Figure 50 Showing along Figure 47 The plane intercepted by line 50-50 in the middle Figure 47 A cross-sectional view of the multi-directional control handle;

[0052] Figure 51 Showing the removal of the drive component Figure 50 A cross-sectional view of the control handle;

[0053] Figure 52 Showing the removal of the drive component Figure 50 An exploded view of the control handle;

[0054] Figure 53 An exploded view of an embodiment of the double-threaded nut and follower assembly is shown.

[0055] Figure 54 A perspective view of an embodiment of a control handle with a planetary gear assembly is shown;

[0056] Figures 55A-55C Showing Figure 54 A perspective view of the planetary gear assembly of the example handle;

[0057] Figures 56A-56C Showing Figure 54 A cross-sectional perspective view of the planetary gear assembly of the example handle; and

[0058] Figure 57 Showing Figure 54 A top sectional view of the planetary gear assembly of the example handle. Detailed Implementation

[0059] As used herein, the singular forms “a,” “an,” and “the” refer to one or more species unless the context clearly indicates otherwise.

[0060] As used herein, the term "comprising" means "including". For example, a device that includes or contains A and B includes A and B, but may optionally include C or other components other than A and B. A device that includes or contains A or B may include A or B or A and B, and optionally one or more other components, such as C.

[0061] refer to Figure 1 This application relates to a maneuverable catheter assembly 1 that utilizes various mechanisms to achieve independent control over the magnitude and direction of catheter bending, thereby improving the maneuverability of the attached catheter 2. By employing mechanisms that independently determine the circumferential angle and radial magnitude of catheter bending, the user gains more direct, intuitive, and precise control over catheter manipulation. Figure 1 The embodiment illustrated shows a catheter 2 that defines a longitudinal axis extending between a proximal end 8 and a distal end 9. The catheter 2 further defines a circumferential C ( Figure 1 As shown), the circumference C further defines the radius R around the longitudinal axis. The catheter 2 can be bent radially and is controlled by a control handle 5, which can include independent control of the bending magnitude 6 and the bending direction 7, the bending magnitude 6 determining the variable radial distance R of the bending of the distal end 9 of the catheter 2, and the bending direction 7 being the circumferential angle at which the bending of the distal end 9 of the catheter 2 occurs.

[0062] Figure 1 The bending level control 6 and bending direction control 7 are conceptually illustrated because these controls can take many forms and utilize various mechanisms further described herein. The bending level control 6 and bending direction control 7 can be any knob, lever, switch, dial, device receiving manual or digital input, or other device adapted to receive input from the user to actuate the bending level and bending direction controls at the distal end 9 of the catheter 2 or other transluminal device. In the embodiments disclosed herein, the bending level control 6 and bending direction control 7 determine at least two traction wires ( Figure 1 (not shown) tension in the catheter. In the embodiments described herein, at least two traction wires are attached to the control handle 5 and the distal end 9 of the catheter 2 such that the increased tension in the first traction wire relative to the tension in the other traction wires pulls the distal end 9 of the catheter 2 in the direction of one or more wires.

[0063] In one exemplary method, starting with an attachment catheter having a straightened distal tip, the user can adjust the bend level control 6 by an amount sufficient to cause the distal tip of the catheter to bend radially from its longitudinal axis in the straightened position to a desired angle (e.g., a bend angle of 30 degrees from the straight position). This bend can be purely radial, without circumferential movement (e.g., radial bend can occur when the distal tip is at a fixed circumferential angle of zero degrees). The user can then adjust the bend direction control 7 to gradually change the circumferential angle of the distal tip's radial bend. For example, adjusting the bend direction control 7 in one manner can cause the circumferential angle of the distal tip to change clockwise, while adjusting it in the opposite manner can cause it to change counterclockwise. This change in circumferential angle can be made while maintaining the degree of radial bend of the distal tip. Furthermore, when the bend direction control 7 is used to change the circumferential angle of the distal tip bend, the catheter itself does not need to be rotated within the patient's body. Instead, the distal end of the catheter bends only in a circumferential direction, different from the straight state, while the rest of the catheter remains stationary.

[0064] In another exemplary method, starting with an attachment catheter having a straightened distal tip, the user can first adjust the bending direction control 7 to rotate the cam 14 to a selected circumferential position corresponding to the desired bending direction of the distal tip of the catheter 2 (e.g., 270 degrees clockwise relative to a specified reference point). The user can then adjust the bending magnitude control 6 by an amount sufficient to cause the distal tip of the catheter to bend radially in the desired direction to a desired angle relative to the longitudinal axis of the straightened position (e.g., a bending angle of 30 degrees relative to the straight position). This bending can be purely radial, without circumferential movement (e.g., a radial bend from 0 degrees to 30 degrees can occur when the distal tip is at a fixed circumferential angle of 270 degrees).

[0065] Figure 2 and 3 An example of an embodiment of the catheter control handle 5 is provided, which is attached to the catheter 2 (in...). Figure 2 and 3 Not shown in the text, but see [link / reference]. Figure 1 This provides cam-controlled multi-directional operability. The distal end 20 of the handle can be connected to the conduit 2 (see...). Figure 1 The catheter 2) or other long and manipulable tubular or transluminal device is inserted into the patient, and the proximal end 21 may include a lumen channel to allow other devices, traction wires and / or fluid to pass through the handle 5 and the attachment catheter.

[0066] Figure 2 and Figure 3The handle 5 may include a cam member 14 having an inclined cam contact surface 15 along which a follower 22 slides. The follower 22 is restricted to axial movement only, such that it acts as a cam follower. Figure 2 and Figure 3 The follower 22 in the illustrated embodiment is a slider, but other suitable types of followers, as further described herein, also function in various other embodiments of the invention. The follower 22 can be coupled to a conduit 2 (see [link to conduit]). Figure 1 The traction wire extending from the side of the ) Figure 2 and 3 (Not shown), causing the axial movement of the follower 22 in the slot 23 to apply / adjust tension to the attached traction wire. Any number of followers 22 and traction wires may be included.

[0067] Figure 2 and Figure 3 The handle 5 may include a first knob 24 (referred to herein as the "bend knob") that causes the cam 14 to translate axially relative to a longitudinal axis extending between the distal end 20 and the proximal end 21. The bend knob 24 acts as a bend level control. Figure 1 (6). Figure 2 and 3 The handle 5 may also include a second knob 25 (referred to herein as the "steering knob"), which causes the cam 14 to rotate circumferentially relative to the longitudinal axis of the handle 5. The steering knob 25 acts as a bending direction control. Figure 1 7). Figure 2 and 3 The handle 5 may optionally include a third knob 26 (referred to herein as the "clutch knob"), which acts as a clutch or brake to lock the cam 14 in the rotational position selected by the operating knob 25, while allowing adjustment of the cam's axial position by bending the knob 24.

[0068] By rotating the bending knob 24, the user can move the cam 14 axially relative to the rest of the handle 5, which causes all the followers 22 engaged with the cam to move axially a corresponding distance. This, in turn, causes all the traction wires attached to the followers 22 to increase or decrease tension together, resulting in the distal tip of the attached conduit ( Figure 1 The radial bending magnitude of (9) changes without altering the curvature of the duct tip ( Figure 1 9) The circumferential angle relative to the longitudinal axis of the catheter.

[0069] By rotating the control knob 25, the user can rotate the cam 14 and its inclined contact surface 15 about the central longitudinal axis of the handle, causing one or more followers 22 to move distally in the slot 23, and one or more other sliders 22 to move proximally in the slot 23—depending on which part of the inclined contact surface 15 contacts each follower 22. This can result in an increase in tension in one or more traction wires, while the tension in one or more other traction wires decreases, causing the distal tip of the attached catheter to pivot about its longitudinal axis and change the circumferential angle of its radial curvature (without rotating the entire catheter within the patient).

[0070] Therefore, each of the bending knob 24 and the operating knob 25 can individually adjust part or all of the follower 22—depending on which follower 22 engages the inclined contact surface 15 of the cam 14. Each knob 24 and 25 can produce independent but complementary final adjustments to the distal tip of the conduit.

[0071] The bending knob 24 and the actuating knob 25 can rotate simultaneously or separately. For example, in an exemplary method, the two knobs can be rotated simultaneously (in the same direction of rotation or in opposite directions of rotation). Simultaneous rotation of the two knobs causes the cam 14 to slide axially and rotate circumferentially simultaneously, which results in the distal tip of the conduit ( Figure 1 9) Change its bending magnitude and change the circumferential direction of the bending. Handle 5 can be operated manually with one or two hands. Since knobs 24 and 25 are close to each other, the user can operate both knobs with one hand while holding handle 5.

[0072] like Figure 2 and 3 As shown, the handle 5 may include a distal nose cone 12, a bending member 13 (which may include a bending knob 24 and a threaded body 44), a cam 14, a pin 18, a retaining follower guide 41 (including a distal body 48 and a proximal body 49—having a follower groove 53), followers 22—each follower 22 having an outwardly projecting sliding pin 54, a back plug 55 having a disc-shaped portion 56 and a proximal shaft 58, a positioning member 42 (including a proximal cylinder 52 of the operating knob 25—having a groove / recess 53), a washer 28, a spacer 30, an outer sheath 32, a clutch knob 26, a proximal gasket 36, and a proximal end cap 38 forming the proximal end 21. Various retainers / fasteners (e.g., retaining rings 57) may also be included. Figure 1 As shown. Figure 3As shown, follower 22 can slide axially along groove 53, while its sliding pin 54 protrudes radially to cam 14. Cam 14 is positioned between proximal body 49 and proximal cylinder 52 such that sliding pin 54 contacts follower contact surface 15 of cam 14. Cam 14 can be coupled to positioning member 42 such that rotation of operating knob 25 causes cam rotation, while proximal cylinder 52 allows cam 14 to slide axially between fixed sliding guide 41 and positioning member 42.

[0073] The threaded body 44 of the bending member 13 can be positioned around the distal body 48 of the fixed sliding guide 41 and also engages with the cam 14, such that rotation of the bending member 13 drives the cam to move axially relative to the cylinder 52 of the fixed sliding guide 41 and the positioning member 42.

[0074] Clutch knob 26 may have an engaged position and a disengaged position. When in the engaged position, actuation knob 25 can be locked, such that the circumferential angle of the distal tip of the attachment conduit is fixed, while allowing bending knob 24 to axially drive cam 14 and change the degree of bending of the distal tip of the attachment conduit. In an alternative embodiment, clutch knob 26 may be configured such that, when in the engaged position, bending knob 24 is locked, maintaining a constant degree of bending of the attachment conduit, while allowing actuation knob 25 to circumferentially rotate cam 14 and change the circumferential angle of bending. When clutch knob 26 is in the disengaged position, both bending knob 24 and actuation knob 25 are active. In another embodiment, handle 5 includes two clutch knobs, one for locking actuation knob 25 and one for locking bending knob 24.

[0075] Each follower 22 may be attached to one end of a traction wire that extends distally through the handle 5 beyond the distal end 20 and along the attachment catheter. The handle 5 may include two or more followers 22 and associated traction wires. The example embodiment includes four followers 22, each circumferentially spaced from each other at approximately 90 degrees; however, as discussed further below, other numbers of followers arranged with different circumferential spacing arrangements may be used to influence the controllable catheter assembly's controllability.

[0076] refer to Figure 43 —It shows a maneuverable catheter 2 with attachment. Figure 2 and 3 In this control handle implementation, rotating the bending knob 24 causes the conduit 2 to move in the radial direction (e.g.) Figure 43 The cam member 16 bends in any one of the four exemplary radial directions R1, R2, R3, and R4 (or in any direction between the marked directions). When the cam member 16 is in its distal position, i.e., not engaged with any follower 22, the guide tube 2 can be relaxed and / or not bend, as... Figure 43Position P1 is shown in the diagram. However, when the cam member is axially driven, the follower 22 moves with it, and the attached traction wire is tensioned, causing the guide tube 2 to bend radially, for example, to... Figure 43 The bending position is marked with any one of P1, P2, P3, or P4. The circumferential angle of the bend in catheter 2 is determined by the position of the operating knob 25. The rotational position of the operating knob 25 corresponds to the circumferential movement of the bent catheter 2 in the circumferential direction. Figure 43 The dotted arrow C marks the position. For example, if catheter 2 is currently in the bent position P4, rotating the control knob 25 (when the bending knob is fixed) will move catheter 2 along the dotted line to position P3 or P5 (without rotating catheter 2 about its central longitudinal axis). If catheter 2 is currently in the non-bent position P1, rotating the control knob 25 will not cause any movement of catheter 2 (not even rotation about its central longitudinal axis), but will determine in which radial direction (e.g., R1, R2, R3, and R4) catheter 2 will bend when the bending knob 24 is subsequently rotated. By combining (simultaneously or one at a time) adjusting the bending knob 24 and the control knob 25, catheter 2 can be manipulated to... Figure 43 Any bend within the dashed circle (assuming the dashed line represents the maximum degree of bend), without causing catheter 2 to rotate around its central longitudinal axis within the patient's body.

[0077] Figure 4 and Figure 4A An embodiment of a cam 14 with a cam follower contact surface 15 is shown. The double-headed arrow C describes the circumferential direction relative to the longitudinal axis L of the control handle housing the cam 14. The cam 14 is oriented such that the contact surface 15 can engage the follower, and when the cam 14 is adjusted axially or rotatably (circumferentially relative to the longitudinal axis L), the tension in the traction wire connected to the follower is adjusted. Therefore, the cam contact surface 15 can be longitudinally L-oriented relative to the housing in a proximal or distal direction.

[0078] Figure 4 The cam follower contact surface 15 includes a constant axial slope based on a circumferential angle. Contact surface 15 can include any planar or non-planar profile, such as a planar surface defining an inclined plane that is not parallel to or perpendicular to the longitudinal axis of the handle. The cam follower contact surface of the present invention may further have a shape and / or slope, including flat, rounded, dimpled, divots, concave, pawl, or other shapes. The shape of the cam follower contact surface 15 ultimately determines the interaction with the follower when the user provides input of the magnitude or direction of bending (i.e., the cam 15 is adjusted axially or rotationally). Figure 4AAn embodiment of the cam 14 is illustrated, wherein the cam follower contact surface 15 includes a stop shape 16. The contact surface 15 may include an annular surface that extends circumferentially around the central axis and / or central cavity of the handle receiving the cam 14. Figure 4 and 4A The inner cavity 17 is shown, which will accommodate the handle through the central axis and / or central cavity of the cam 14.

[0079] The following is for reference. Figure 12-16D 20A and 20B provide further discussion of implementations of cams with selectable shapes. The follower contact surface 15 of cam 14 can be configured to provide a desired balance between fine control of the bending angle and the minimum amount of control adjustment required to adjust the bending angle and magnitude. For example, a steeper slope on the cam results in a greater radial bending change per unit adjustment of the bending magnitude control, while a smaller cam surface slope provides finer control over the precise bending magnitude. Modifications to the shape of cam 14 allow for further variations and adjustments in control aspects, as well as addressing the "drift" problem that may occur in cam-follower systems, as discussed further below.

[0080] Since the cam member can provide a similar adjustment mechanism, the use of a cam member in the control handle of this disclosure provides an unlimited range of choices when selecting the desired bending position of the distal tip of the attached conduit. Furthermore, with respect to the control handle 5, an increase in the number of sliders included and coupled to the follower 22 and / or an increase in the number of traction wires can improve the smoothness of similar control systems described herein.

[0081] Figure 5-20B The diagram illustrates the conduit curvature according to the movement of the cam and follower 22, the interface between the cam and follower contact surfaces 15, the shape of the cam contact surfaces 15, and the number and spacing of the followers 22. All cam follower contact surfaces in the example are shown extending from point A (shown on the left for illustrative purposes) to the same point A (shown on the right for illustrative purposes). This example shows a continuous cam follower contact surface extending around a circumference of the longitudinal axis defined by the control handle housing. Figure 5-15 Figures 18A-18B and 20A-20B are illustrations of an implementation including four followers F1, F2, F3, and F4. Some of these figures also depict a continuous arrangement mapped to a line extending from left to right, where a repetition of one follower (here, F3) indicates the same follower, and thus indicates the continuity of the follower arrangement.

[0082] Figure 5 The illustration shows an embodiment of the smooth cam follower contact surface 15, as shown in the figure. Figure 4 As shown, it has four followers: F1, F2, F3, and F4. Figure 5In this configuration, the cam follower contact surface 15 is axially positioned so that it does not engage with any follower. At this position, the traction wires connected to each follower are under minimum tension, thus providing zero bending. Figure 6 Showing Figure 5 The cam follower contact surface 15—after surface 15 has been axially translated as shown by arrow D6, resulting in a corresponding increase in the bending magnitude R. Figure 6 In the illustrated embodiment, contact surface 15 engages only with follower F1, thereby increasing the tension in the traction wire connected to follower F1 and pulling the attached conduit radially along F1. Therefore, in the embodiments disclosed herein, axial adjustment of contact surface 15 results in a corresponding adjustment of the magnitude of bending in the follower direction in which contact surface 15 engages. Figure 7 Showing Figure 6 The cam follower contact surface 15—after the cam has rotated as indicated by arrow E7, causing a corresponding change in the bending direction ℃. The cam rotation as indicated by arrow E7 causes contact surface 15 to engage with follower F2, while continuing to engage with follower F1, but at a different axial position. Therefore, the magnitude of bending decreases in the direction of the traction wire attached to F1, and increases in the direction of the traction wire attached to F2, causing the attached conduit to... Figure 6 The catheter position shown is in Figure 7 The center shifts towards the direction of F2. For example... Figure 8 As shown, the further rotation of the cam, as indicated by arrow E8, causes the contact surface 15 to completely disengage from the follower F1 and engage with the follower F2 in a new axial position. Therefore, the magnitude of the bend in the direction of the traction wire attached to F1 further decreases, and the magnitude of the bend in the direction of the traction wire attached to F2 further increases, resulting in the attached conduit relative to... Figure 7 The catheter position shown is in Figure 8 The center shifts towards F2 in more directions.

[0083] Figure 9-11 This shows the positions of cam surface 15 and followers F1, F2, F3, and F4 after the cam surface has advanced axially. Figure 9 In the middle, the cam surface propulsion follower F1 (and Figure 6 Compared to this), it also engages and propels the driven members F2 and F4 to a lesser extent. Therefore, compared to... Figure 6 In comparison, the magnitude of bending along the follower F1 direction increases. Figure 10 In the middle, the driven members F1 and F2 are pushed (with) Figure 7 (Compared to). Therefore, with Figure 7 In comparison, the magnitude of bending along the directions F1 and F2 of the follower increases. Figure 11 In the middle, the driven member F2 is pushed (with Figure 8Compared to the previous model, the cam also engages the followers F1 and F3 to a lesser extent. Therefore, compared to... Figure 8 In comparison, the magnitude of bending along the follower F2 direction increases.

[0084] Figure 12-15 An embodiment of a smooth cam follower contact surface 15 with a stop shape 16 is illustrated. In this example, the stop shape 16 is sized such that the cam surface always engages at least two followers. Figure 12-15 The example shows four followers: F1, F2, F3, and F4. Figure 12 The contact surface 15 is shown, which is axially positioned such that the pause shape 16 is flush with the slack position line. Figure 12 The cam implementation described in the text does not affect the magnitude of the guide tube bending in this position. Figure 5-11 The described cam implementation will be in the same axial position. Figure 13 This shows the axial translation as indicated by arrow D13. Figure 12 The contact surface 15 of the cam and follower system embodiment described herein. In this position, the contact surface 15 engages the followers F1, F2, and F4. Compared to the follower engaging with the cam in the axial position of the system without a stop shape, the follower F1 does not generate as much tension in the attached traction wire, and therefore does not generate such a large amount of bending in the follower direction of F1. Figure 14 The rotation shown by arrow E14 is displayed. Figure 13 The contact surface 15 of the cam and follower system embodiment described herein. In this position, the contact surface 15 engages followers F1 and F2, but not F4, to rotate the guide tube to the combined direction between followers F1 and F2. Since followers F1 and F2 engage contact surface 15 at pause 16, followers F1 and F2 translate axially equally, thereby applying equal tension to the attached traction wire and causing equal bending magnitudes in the directions of followers F1 and F2. This can be achieved as follows: Figure 14 The contact surface 15, indicated by arrow E14, undergoes further rotation such that the stop shape 16 of the contact surface 15 remains in contact with the followers F1 and F2 before the follower F3 engages. Despite some directional adjustment as indicated by arrow E14, the conduit orientation remains unchanged. Therefore, the stop shape 16 provides tolerance for the inaccuracies of adjustments made by the user in the operable conduit assembly embodiment described herein. When utilizing the stop shape 16, the device of this disclosure can effectively “ignore” insignificant or unintentional adjustments by the user to directional control. The size of the stop shape can be increased to “ignore” larger adjustments, or decreased to have the opposite effect. Furthermore, as described below, the stop shape solves the “drift” problem when its length matches at least the minimum distance between the followers. Figure 15In this configuration, the cam engages with followers F1, F2, and F3, and the direction of the guide tube's bending changes. The pause shape also ensures that the cam surface is always in contact with at least two followers, preventing the guide tube from jumping from one rotational position to another as the cam rotates.

[0085] Figures 16A-16D An illustration shows an alternative embodiment of the contact surface 15. As described above, the cam and follower contact surfaces of embodiments of the invention can include any planar or non-planar profile, such as a planar surface defining an inclined plane that is not parallel to or perpendicular to the longitudinal axis of the control handle housing the cam. The cam follower contact surface 15 can include shapes and / or slopes including planar, rounded, dimpled, turf-like, concave, ratchet, or other shapes. The shape of the cam follower contact surface 15 ultimately determines the interaction with the follower when the user provides input on the bending magnitude or bending direction (i.e., the cam 15 is adjusted axially or rotationally). The follower contact surface 15 of the cam 14 can be configured to provide a desired balance between fine control of the bending angle and the minimum amount of control adjustment required to adjust the bending angle and magnitude. For example, a steeper slope on the cam results in a greater radial bending change per unit adjustment of the bending magnitude control, while a smaller slope on the cam surface provides finer control over the precise bending magnitude.

[0086] Figure 16A It is a diagram of a cam follower contact surface 15 with a stop shape 16 and a flat shape 60. Figure 16B It is a diagram of the contact surface 15 of the cam follower with a stop shape 16, a rounded shape 62, and a flat shape 60. Figure 16C This is an illustration of a cam follower contact surface 15 having a stop shape 16, a flat shape 60, and a concave or pawl shape 64. The pawl shape 64 provides tactile feedback to the user because it provides cam rotational resistance when engaging with the follower, and also provides a directional locking function for finer control. Figure 16D This is an illustration of the cam follower contact surface 15, which has a smooth surface with sides that gradually increase in steepness, such that for a given rotation of the cam, the contact surface engages with the follower rapidly and then disengages rapidly. Such a contact surface 15 can provide finer control for embodiments that include multiple followers.

[0087] Figure 17A and 17B This is a diagram of a cam and follower system including contact surface 15 and three and two followers respectively. A smaller number of followers reduces the fineness of control. Figure 17B The contact surface 15 shown in the embodiment of the cam follower system illustrates the contact surface 15 between followers F1 and F2. Figure 17BThe contact surface 15 is capable of not engaging any follower, even at certain locations where the contact surface 15 has been axially translated beyond the slack line position. In such a system, a "drift" problem is possible. "Drift" is a process in which, for a constant axial position of the cam, rotation of the cam causes the cam to completely disengage from all cam followers, thereby eliminating tension in the attached traction wire. In the embodiments described herein, this can correspond to the conduit bending magnitude unexpectedly (to the user) shifting to zero. As mentioned above, adding a stop shape can eliminate this problem because the stop shape is wide enough to span the maximum gap between the followers.

[0088] Figure 18A and 18B The illustration shows an implementation of a cam follower system with variable spacing between followers. Figure 18A An embodiment with four followers F1, F2, F3 and F4 is depicted, which are evenly spaced (spaced distance X1) around a circumference centered on the longitudinal axis of the control handle housing the cam follower system. Figure 18B An implementation with four followers F1, F2, F3, and F4 is depicted, which are not uniformly spaced (spaced by distances X3, X4, and X5) around a circumference centered on the longitudinal axis of the control handle housing the cam follower system. As described above, the alternating spacing of the followers can be used to mitigate the "drift" problem, or can be configured to provide a desired balance between fine control of the bending angle and the minimum amount of control adjustment required to adjust the bending angle and magnitude in different directions. For example, a narrower spacing between the followers results in a smaller radial bending change per unit adjustment of the bending magnitude control, while a larger spacing between the followers provides less fine control over the precise bending magnitude.

[0089] Cam rotation can also be restricted to help mitigate drift. Figure 19 The diagram illustrates a cam that can only rotate 90° relative to the longitudinal axis of the control handle housing. Within the cam's rotation range, followers F1 and F2 are circumferentially spaced 45° or less relative to the longitudinal axis. Therefore, when the cam is axially advanced beyond the slack line position, the cam follower contact surfaces will always be in contact with at least one follower F1 or F2.

[0090] like Figure 20A and 20B As shown, in the disclosed embodiments, the cam contact surface 15 can change its size and shape according to axial displacement. In some disclosed embodiments, the cam is a strip cam made of metal, polymer, or other suitable material that is generally flexible but retains local rigidity to interact with the cam follower. Figure 20B It shows the cam moving from its position in Figure 20AThe position in the middle is axially advanced to its position in Figure 20B The illustration shows a cam whose position gradually narrows and steepens. Such a cam follower contact surface 15 has the following advantages: compared with a larger cam follower contact surface, it can provide finer control by engaging fewer followers at larger scales, while retaining the advantage of reducing drift caused by shallower cam slopes at lower scales.

[0091] Figure 21-22 Another exemplary control handle 5 is illustrated, comprising a protrusion 116 and a ball-and-socket mechanism, wherein the socket is coupled to a traction wire such that the orientation of the socket relative to the ball determines the tension in the traction wire, thereby determining the position of the attached catheter. Embodiments disclosed herein may further include a central tubular shaft 102, 103 having a proximal end 104 and a distal end 106, a proximal component 110 fixed to the shaft, a socket 112, and a ball 120 mounted within the socket. The proximal component 110 includes a bending knob 114 and a protrusion 116 contacting an engagement surface 124 of the socket 112. The rotational orientation of the socket 112 relative to the protrusion 116 (e.g., selected by rotating the socket) determines how the socket 112 is tilted relative to the ball 120, which determines the circumferential angle at which the distal tip of the catheter points. The axial position of the protrusion 116 relative to the socket 112 (e.g., selected by rotating the bending knob 114) determines the magnitude of the axial bending of the distal tip of the catheter. The socket 112 may have a notch 126 and grooves 128, 130 on its outer periphery. Multiple guidewires can be connected to the socket around the socket through the notch 126 and grooves 128, 130 and extend distally into the catheter. However, the guidewires can be connected to the socket in any manner.

[0092] The radius of the socket 112 can be increased to increase the maximum tension that can be applied to the traction wire (and thus the maximum amount of bending of the attached catheter). The traction wire can also be coupled to the socket 112 via a rack and pinion or pulley assembly. As discussed further below, such a mechanism provides the mechanical advantage of amplifying the relatively small movements of the protrusion 116 and the socket 112 to provide the desired bending within the catheter. The mechanism system that couples the operating knob and bending knob to the traction wire can be configured and / or calibrated to provide a desired balance between fine control and the range of catheter bending movement. A ball-and-socket mechanism can provide similar full 360-degree adjustability for catheter bending without rotating the catheter within the patient.

[0093] Figure 23-39 Further embodiments of control handles 200 and 300 are illustrated, each including a protrusion that engages with a universal joint to control tension on a traction wire coupled to an attached conduit. Figure 23-32A handle 200 is shown, comprising a housing 210 having a distal end 212 and a proximal cavity 214 containing a universal joint mechanism including an outer universal ring 216 and an inner universal plate 218. The ring 216 is pivotally mounted relative to the housing 210 at a pivot joint 250, such that the ring can rotate relative to the housing about a ring axis perpendicular to the longitudinal axis of the handle passing through the joint 250. The plate 218 is pivotally mounted relative to the ring 216 at a pivot point 252, such that the plate can rotate relative to the ring about a plate axis perpendicular to the ring axis passing through the joint 252. The plate axis and the ring axis are rotatably fixed about the housing axis, but the plate can pivot multidirectionally relative to the housing when the ring pivots relative to the housing through the joint 250 and the plate pivots relative to the ring through the joint 252.

[0094] The control handle 200 also includes two or more traction wires 222. The universal joint 218 may include wire engagement portions 220 for each traction wire 222 of the handle. The four traction wires 222... Figure 23-32 The example is provided as an instance. Each wire 222 passes through a channel 226 in the handle and extends from a distal opening 228 into an attached conduit or other similar maneuverable device. The wire 222 may optionally surround a corresponding wire engagement portion 220 in the universal joint 218, such as... Figure 23 and 24 As shown, the end 224 of the wire extends back to the fixed attachment point on the housing. In such an embodiment, the wire engagement 220 may include rounded studs, pulleys, or other features to facilitate sliding of the wire around the engagement with minimal friction and kinking when the plate is hinged. This arrangement provides mechanical advantages, effectively halving the tension applied to the wire while allowing the distal end of the wire in the guide tube to move at twice the rate of movement of the wire engagement in the plate. In an alternative embodiment, the wire may terminate at the wire engagement 220 in the universal joint without any mechanical advantages, which avoids bending of the wire.

[0095] In the embodiments disclosed herein, the handle 200 includes a central shaft 230 having a distal end 232 coupled to a housing 210; an intermediate portion passing through an opening 219 in a universal joint 218 and through a protrusion 234; and a proximal end portion fixedly coupled to a bend knob 240. The distal end 232 is coupled to the housing via a rotary bearing that allows the shaft 230 and the bend knob 240 to rotate relative to the housing and the universal joint, but prevents longitudinal movement of the shaft 230 and the bend knob 240 relative to the housing and the universal joint. Although not shown, the central shaft 230 and the bend knob 240 may include a central cavity extending through their entire length. The housing 210 may also include a central cavity extending from the distal end of the shaft 230 to the distal end 212 of the handle. The combined central cavity of the handle 200 may provide access to the patient through the handle and through a connecting lumen in an attachment catheter for other devices and / or fluids. The protrusion 234 may be as follows: Figure 23 The cam, or other protrusion shown, such as a pin or a pin having a ball rotatably attached to the distal end of the pin to allow the ball to roll on the universal joint 218, is as follows: Figure 24 As shown

[0096] exist Figure 23-32 In this configuration, the handle 200 also includes an operating knob 242, which may include an indicator node 244 fixedly connected to the protrusion 234 and positioned about the distal side of the curved knob 240 around the central axis 230. The protrusion 234 and / or the operating knob 242 may be threaded or helically engaged with the outer surface of the central axis 230. Figure 27 As shown, when the bending knob 240 and the central shaft 230 rotate relative to the operating knob 242 and the cam member 234 (arrow 1) (e.g., by keeping the operating knob fixed relative to the housing 210 and rotating the bending knob relative to the housing 210), the operating knob and the cam member are driven distally (arrow 2) or proximally relative to the housing and the universal joint, causing the universal joint to pivot (arrow 3) and change the tension on all the traction wires.

[0097] The degree of conduit bending is adjusted by driving the cam member distally or proximally using the bending knob 240. Distal movement of the cam causes the universal joint to tilt more, resulting in an increased degree of bending, while proximal movement of the cam member allows the universal joint to return to its natural position closer to its longitudinal axis perpendicular to the handle, reducing conduit bending. Rotating the bending knob 240 causes the conduit to bend circumferentially (relative to the longitudinal axis defined by the handle 200), the bending being determined by the universal joint position caused by the rotation of the protrusion 234 about the longitudinal axis defined by the handle 200. The circumferential angle of conduit bending is determined by the position of the operating knob 244, which rotates the protrusion relative to the universal joint 218.

[0098] Figure 30-32 An example is illustrated where the control knob 242 is rotated to change the circumferential angle of the radial bend of the conduit. The rotational position of the control knob 242 can be visually and / or tactilely indicated by the node 244 or other indicators. The control knob 242 and the attached protrusion 234 can rotate 360 ​​degrees relative to the universal joint about its central axis. The rotational position of the control knob determines where the distal end of the protrusion 234 contacts the universal joint 218, and thus determines the tilt position of the universal joint 218 when the protrusion 234 is driven into the universal joint 218 using the bending knob 240.

[0099] The universal joint 216 and the universal plate 218 work together to allow the plate to tilt in any direction, and thus allow the attached conduit to bend in any radial direction. Figure 30 In the middle, ring 216 is fixed, and plate 218 is tilted around the plate axis, pulling filament G and relaxing filament F. This causes the guide tube to bend in the direction of filament G. Figure 31 In the middle, ring 218 rotates about its axis, and plate 216 rotates about its axis, pulling filaments G and H and relaxing filaments F and K. This causes the guide tube to bend along the direction between filaments G and H. Figure 12 In this configuration, plate 218 is fixed relative to ring 216, and the ring and plate rotate in unison around the ring axis, pulling the filament H and relaxing the filament K. This causes the guide tube to bend in the direction of filament H.

[0100] In some implementations, the universal joint may have a non-planar contact surface, and the universal joint may have circumferentially and / or radially varying ridges (one or more) and / or valleys (one or more). These can compensate for any discretization effect of not using an unlimited number of traction wires around the joint. For example, when the cam member pushes the universal joint between two wires, a little additional tension may be required on the traction wires to achieve the same amount of bending at the distal end of the conduit. These ridges or valleys can be used to provide additional tension by slightly tilting the joint at certain circumferential and radial cam contact locations. For example, if a completely flat universal joint is used, slight unflexing may occur when adjusting the operating knob to position the bending direction between two of the traction wires. The presence of a gradual ridge at the location between the traction wire engagement portions on the universal joint (by way of example only) can compensate for the desired unflexing by tilting the universal joint slightly more when the cam contacts the ridge, thereby providing the additional traction wire movement required to maintain a constant amount of bending in the direction between the two traction wires.

[0101] Figure 33-39An embodiment of a control handle 300 is illustrated, which includes a protrusion that engages with a universal joint to control tension on at least two traction wires. The control handle 300 functions in a similar manner to the control handle 200, the main difference being that, compared to handle 200, a conduit is connected to the longitudinally opposite ends of the handle, and the traction wires fold back along their original path and extend from the longitudinally opposite ends of the handle, flipping the distal and proximal directions.

[0102] The handle 300 includes a housing 310, a proximal end 314, and a distal end 312 at or near a bend knob 322. The bend knob 322 is axially fixed relative to a central axis 320, and an operating knob 324 is positioned around and / or inside the bend knob with a threaded engagement or helical interface, such that rotation of the bend knob axially drives the operating knob and protrusion 326 relative to a universal joint within the housing. The universal joint includes a universal ring 316 pivotally mounted within the housing about a ring axis; and a universal plate 318 pivotally mounted within the ring via a pivot along a plate axis perpendicular to the ring axis, as in the handle 200. The handle 300 may also include a wire guide plate 330 mounted within the housing 310 on the proximal side of the universal joint.

[0103] Each traction wire in the handle 300 may have an end 340 fixed to the wire guide plate 330, a first portion extending distally from the wire end 340 to the universal plate 318 and extending around a pulley or other guide 342 in the universal plate, an auxiliary pulley or guide 344 extending proximally from the universal plate to the wire guide plate 330 and then around the pulley or guide 344, and a third portion extending distally along the length of the handle and through the distal end 312 of the handle to a conduit connected to the handle.

[0104] Figure 35 The example illustrates how rotating the bending knob 322 (arrow 4) causes the protrusion 326 to move axially (arrow 5) and how it causes the distal edge of the protrusion 326 to tilt the universal plate 318 and / or the ring 316 (arrow 6), which adjusts the bending magnitude of the attachment conduit.

[0105] Figure 36 The diagram shows the handle 300 in a relaxed position when the protrusion does not tilt the ring 316 or plate 318. In this state, the attached conduit can be in a relaxed, non-bent, neutral position. Figure 37 The protrusion 326 is shown to advance proximally, tilting the universal plate 318 while the universal ring 316 remains fixed. This causes the attached conduit to bend in the selected radial direction. Figure 38 The protrusion 326 is shown from its position. Figure 38The position within rotated a few degrees, causing both the universal joint and the ring to pivot. This resulted in the attached conduit... Figure 37 The magnitude of the bending is approximately the same as that of the bending, but in a correspondingly different radial direction. Figure 39 In the middle, protrusion 326 from its in Figure 37 The position is rotated approximately 90 degrees, causing the universal joint to pivot relative to housing 310, but the universal plate does not pivot relative to the universal joint. In this position, the radial amount of bending of the attached conduit is approximately... Figure 37 and 38 Same, but bending direction is the same as Figure 37 The corresponding direction of the middle catheter position is approximately 90 degrees.

[0106] As the universal joint 318 moves relative to the wire guide plate 330, the traction wire is articulated around the wire guides 342 and 344 in the two plates, providing the mechanical advantage of amplifying the relatively small movements of the cam member and the universal joint to provide the desired curvature in the catheter. Like the handle 200, the mechanism for connecting the knobs 322 and 324 to the traction wire can be configured and / or calibrated to provide a desired balance between fine control and the range of catheter bending movement. The universal joint mechanism of the control handle 300 also provides similar full 360-degree adjustability for catheter bending without rotating the catheter within the patient. Furthermore, like the universal joint 218 of the control handle 200, the radius of the universal joint 318 can be increased to increase the maximum tension that can be applied to the traction wire (and thus increase the maximum magnitude of bending of the attached catheter).

[0107] Figure 40This is a schematic diagram of an example optional handle system 400 for coupling a universal joint to a traction wire without causing the traction wire to loop or coil. System 400 includes a housing 410 in which universal rings 412 and universal plates 414 are mounted inside the housing; fixed rack drives 416 are fixedly mounted to the housing; movable rack drives 422 are opposite to each fixed rack drive 416 and coupled to the traction wire 424; rolling gear drives 418 mesh between the fixed rack drives and the movable rack drives; and rigid connector members 420 are coupled from the universal plates 414 to the centers of each gear drive 418. A protrusion (not shown) causes movement of the universal joint, which pulls and pushes the rigid connector members 420, causing the gear drives 418 to roll accordingly along the fixed rack drives 416. For each unit of distance the gear drive 418 rolls, the moving rack drive 422 moves in the same direction but twice as far, resulting in a mechanical advantage: the movement of the protrusion is amplified into a larger movement of the traction wire, eliminating the need for pulleys or other devices that require the traction wire to be coiled or bent at acute angles (which would damage the wire over time). Although this embodiment describes a rack-and-pinion assembly for a control handle based on a universal joint, the rack-and-pinion assembly can be similarly implemented in any other embodiment described herein—by ​​utilizing the rack-and-pinion assembly to connect the driven member to the traction wire.

[0108] Figure 41 and 42 Side views of the rod assembly 4100 and the pulley assembly 4200 are shown respectively. Figure 41 In this configuration, the short end 4102 of the lever arm 4104 is connected to the wire 4106, which is then connected to the handle mechanism. The long end 4112 of the lever arm is connected to the guide wire 27. Therefore, the movement of the wire 4106 is amplified within the guide wire 27 via the lever assembly. Figure 42 In this configuration, the small hub 4202 of the pulley assembly 4200 is connected to the wire 4206, which is connected to the handle mechanism. The larger hub 4212 of the pulley assembly is connected to the catheter traction wire 27. Therefore, the movement of the wire 4206 caused by the handle mechanism is amplified in the traction wire 27 via the pulley assembly 4200. These components can be similarly implemented in any other embodiment described herein—by ​​utilizing this assembly to connect the driven member to the traction wire, a mechanical advantage is gained: amplifying relatively small movements to provide the desired bend at the distal end of the attached catheter.

[0109] Figure 44AAn embodiment of component 500 is illustrated, which engages with a protrusion (not shown) to control tension on at least two traction wires 27. Component 500 is a plate 530 attached to a ball 510, which is rotatably mounted in a socket base 520. The socket base 520 is fixed to the housing of a control handle (not shown). The ball 510 rotates in the direction indicated by arrow N, thereby allowing the plate 530 to rotate and tilt in the directions indicated by arrows M and N. At least two traction wires 27 are attached to the plate 530 on one axial side. Although the traction wires 27 are shown attached to the opposite axial side of the ball 510 attachment side of the plate 530, the traction wires 27 can be attached to the plate 530 on the same axial side as the ball 510, depending on the orientation of the socket base 520 and the traction wires 27 within the control handle housing. Figure 44B A plate 530 is illustrated from an axial side view. In the illustrated embodiment, a hole 531 provides an attachment point for the traction wire 27 in the plate 530. Furthermore, as with the universal joint and ball joint embodiments, the radius of the plate 530 can be increased to increase the maximum tension that can be applied to the traction wire 27 (and thus increase the maximum bending magnitude of the attachment conduit).

[0110] Figure 45A and 45B An embodiment of component 600 is illustrated, which engages with a protrusion (not shown) to control tension on at least two traction wires 27. Component 600 is a plate 630 attached to a deformable sphere 610, which contacts a surface 620. Surface 620 is part of or attached to the housing of a control handle (not shown). The deformable sphere 610 deforms in response to tilting of the plate 630, which in the embodiments disclosed herein is achieved by axial or rotational movement of the protrusion (not shown), thereby allowing the plate 630 to rotate and tilt in multiple directions. Figure 45B Shown in Figure 45A The plate 630, indicated by the middle arrow P, is tilted into a deformable sphere 610 in a deformable configuration. At least two traction wires 27 are attached to the plate 630 on one axial side. Although the traction wires 27 are shown attached to the opposite axial side of the deformable sphere 610 attachment side of the plate 630, depending on the surface 620 within the control handle housing and the orientation of the traction wires 27, the traction wires 27 may be attached to the plate 630 on the same axial side as the deformable sphere 610. Furthermore, as in the universal joint, ball joint, and assembly 500 embodiment, the radius of the plate 630 can be increased to increase the maximum tension that can be applied to the traction wires 27 (and thus increase the maximum bending magnitude of the attachment conduit).

[0111] Figure 46A and 46BAn embodiment of component 700 is illustrated, which engages with a protrusion (not shown) to control tension on at least two traction wires 27. Component 700 is a plate 730 suspended from the housing of a control handle (not shown) by at least one suspension wire 710. The at least one suspension wire 710 allows the plate 730 to tilt in multiple directions, which, in the embodiments disclosed herein, is achieved by applying force to one axial side of the plate 730 in response to axial or rotational movement of the protrusion (not shown). Figure 46B Shown in the protrusion such as Figure 46A The middle arrow Q indicates the suspension plate 730 in an inclined position after force is applied to it. At least two traction wires 27 are attached to the plate 730 on one axial side. The traction wires 27 are attached to the axial side of the plate 730 opposite to the suspension wire 710. However, this protrusion can apply force on either axial side of the plate 730 to control the tension on the at least two traction wires 27. Furthermore, as in the embodiments of the universal joint, ball joint, assembly 500, and assembly 600, the radius of the plate 730 can be increased to increase the maximum tension that can be applied to the traction wires 27 (and thus increase the maximum bending magnitude of the attachment conduit).

[0112] Figures 47-53 The attached catheter was shown. Figures 47-53 (Not shown) A view providing an embodiment and components of a maneuverable catheter control handle 800. The distal end 812 of the handle 800 can be coupled to the catheter (see...) Figure 43 The system 5 includes a catheter 2) or other slender and maneuverable tubular or transluminal device for insertion into the patient, while the proximal end 814 may include a lumen channel to allow other devices, traction wires and / or fluid to pass through the handle 800 and the attached catheter.

[0113] refer to Figure 48 and 49 The control handle 800 includes a drive nut 830, a first follower 831 and a second follower 832, respectively, and a drive member 857 disposed within the control handle 800. Followers 831 and 832 are attached to traction wires (not shown). The drive member 857 translates axially in response to adjustment of the drive knob or bending knob 824, causing axial movement of the drive nut 830. Axial movement of the drive nut 830 causes equal axial movement of the first follower 831 and the second follower 832, resulting in equal adjustment of the tension of the two traction wires (not shown). This adjustment of tension leads to adjustment of the radial bending magnitude of the attached conduit (not shown).

[0114] The drive nut 830 rotates in response to adjustment of the bending knob 825. Rotation of the drive nut 830 causes the first follower 831 and the second follower 832 to move in opposite axial directions. Rotating the operating knob 825 in one direction causes one follower to move axially toward its attached traction wire and the other follower to move axially away from its attached traction wire, thereby generating greater tension in one traction wire and less tension in the other. This causes the attachment conduit to bend in the direction of the tensioned wire. Rotating the operating knob 825 in the opposite direction has the opposite effect on the axial movement of the followers 830, 831, thereby causing the attachment conduit to bend in the direction of the other tensioned wire. Therefore, the operating knob 825 controls the bending direction of the attachment conduit. Embodiments of the control handle 800 may further include a cap 875 and a housing 860.

[0115] In the embodiments disclosed herein and as such Figures 48-49 As shown, the drive element 857 consists of a threaded drive screw 850 and a threaded drive shaft 851. In the control handle 800, adjusting the drive knob 825 causes the threaded drive screw 850 to rotate, which engages with the internal thread of the drive shaft 851. The rotation of the threaded drive screw 850 causes the drive shaft 851 to move axially. A connection 856 is formed between the end of the drive shaft 851 and the end of the drive nut 830. Therefore, the axial movement of the drive shaft causes the double-threaded nut 830 to be pushed or pulled. Since the first follower 831 and the second follower 832 are located within the double-threaded nut 830, the first and second followers move by equal axial vectors. Figure 48 and 49 In the embodiment shown, the drive coupling 856 connects the drive shaft 851 and the double-threaded nut 830 such that axial movement of the drive shaft 851 on the distal or proximal side causes the double-threaded nut 830 to move in the same direction.

[0116] exist Figures 50-53 In this design, the operating mechanism of the control handle 800 includes a double-threaded nut 830, a follower guide 840 with a follower slot 841, and a nut rotor 861. A first follower 831 and a second follower 832 are located in different follower slots 841 of the follower guide 840. The follower guide 840 is fixed relative to the housing 860 and the rotor 861. When the operating knob 825 is adjusted, the nut rotor 861 causes the double-threaded nut 830 to rotate relative to the housing 860 (without axial movement of the double-threaded nut 830 relative to the housing 860).

[0117] like Figure 53As shown, the double-threaded nut 830 is cut with internal double left and right threads 833. The first follower 831 has an external left-hand thread. The thread of the first follower 831 engages with the left-hand thread set in the double-threaded nut 830. The second follower 832 has an external right-hand thread. The thread of the second follower 832 engages with the right-hand thread set in the double-threaded nut 830. For the same rotation of the double-threaded nut 830 caused by the rotor 861, the first follower 831 and the second follower 832, due to their opposite thread action, move in opposite axial directions relative to the housing 860 in the follower slot 841. The attached traction wire is tensioned or relaxed accordingly depending on the axial movement direction of the followers 831 and 832. The traction wire (not shown) is guided through the traction wire guide 855 and reaches the proximal end of the handle 800.

[0118] Figures 54-57 This is a view of an exemplary embodiment of a catheter control handle 900, which is attached to catheter 2 (in... Figures 54-57 (Not shown in the image) provides operability. The distal end 914 of the handle 900 can be coupled to a catheter (see [reference]). Figure 43 The system 5 includes a catheter 2) or other slender and maneuverable tubular or transluminal device for insertion into the patient. The transluminal channel 970 may extend from the proximal end 912 to the distal end 914 to allow other devices, traction wires, and / or fluids to pass through the handle 900 and the attachment catheter.

[0119] The example control handle 900 includes a first follower 931, a second follower 932, a third follower 933, and a fourth follower 934. A first drive 924 is coupled to the first and second followers 931 and 932, which are circumferentially opposite each other. A second drive 925 is coupled to the third and fourth followers 933 and 934, which are also circumferentially opposite each other and positioned at approximately 90° to the first and second followers 931 and 932. Rotation of the first drive 924 causes the first and second followers 931 and 932 to move relative to the control handle 900 in opposite axial directions. Rotation of the second drive 925 causes the third and fourth followers 933 and 934 to move relative to the control handle 900 in opposite axial directions. A traction wire attached to the follower moving proximally relative to the housing 860 increases tension, and a traction wire attached to the follower moving distally relaxes tension. The attachment conduit bends in the direction of the tensioned traction wire. Therefore, the control of the magnitude and direction of the bend is not independent of the control handle 900. The first drive member 924 and the second drive member 925 may be rotatable drive rings with internal teeth 945.

[0120] like Figure 55A-57As shown in the cross-sectional view of the housing 960, the control handle 900 may further include first, second, third, and fourth drive gears 941, 942, 943, and 944, respectively, and first, second, third, and fourth drive screws 951, 952, 953, and 954, respectively. The drive screws are rotatably attached to the housing 960, and each drive gear is fixed to its corresponding drive screw such that rotation of a drive gear causes rotation of its corresponding drive screw without axial movement of the drive screw or drive gear relative to the housing 960. In the disclosed embodiment, the first and second drive gears 941 and 942 mesh with the internal teeth 945 of the first drive member 924, and the third and fourth drive gears 943 and 944 mesh with the internal teeth 945 of the second drive member 925. Furthermore, the first and third drive screws 951 and 953 are left-hand threaded, while the second and fourth drive screws 952 and 954 are right-hand threaded. The first follower 931 and the third follower 933 are provided with internal left-hand threads and engage with the threads of the first and third drive screws 951 and 953, respectively. The second and fourth followers 932 and 934 are provided with internal right-hand threads and engage with the threads of the second and fourth drive screws 952 and 954, respectively. Rotation of the first drive member 924 causes equal rotation of the first and second drive gears 941 and 942, and thus equal rotation of the first and second drive screws 951 and 952. The first follower 931 and the second follower 932 move in opposite axial directions in response to their opposing thread action. The attachment conduit bends in the direction of the follower that moves proximally and thus tensions its attachment traction wire. Rotation of the second drive member 925 causes equal rotation of the third and fourth drive gears 943 and 944, and thus equal rotation of the third and fourth drive screws 953 and 954. The third follower 933 and the fourth follower 934 move in opposite axial directions in response to their opposing threaded action. The attachment conduit bends in the direction of the follower that moves proximally and thus tensions its attachment traction wire.

[0121] It should be understood that embodiments of this disclosure can be configured to deliver and implant prosthetic devices in any natural valve annulus of the heart (e.g., the annulus of the lungs, mitral valve, and tricuspid valve) and can be used in conjunction with any of a variety of methods (e.g., retrograde, anterograde, transseptal, transventricular, transatricular, etc.). Embodiments of this disclosure can also be used to implant prostheses into other cavities of the body. Furthermore, in addition to artificial valves, the delivery component embodiments described herein can also be configured to deliver and implant various other prosthetic devices, such as stents and / or other prosthetic prosthetic devices. In other embodiments, the apparatus of this disclosure can be used to perform various other transvascular surgical procedures besides implanting prosthetic devices.

[0122] For the purposes of this description, certain aspects, advantages, and novel features of embodiments of this disclosure are described herein. The methods, apparatus, and systems of this disclosure should not be construed as limiting in any way. Instead, this disclosure relates to all novel and non-obvious features and aspects of the various disclosed embodiments—individually and in various combinations and sub-combinations of each other. The methods, apparatus, and systems are not limited to any particular aspect or feature or combination thereof, and embodiments of this disclosure do not require the presence of any one or more specific advantages or problem-solving.

[0123] Although some embodiments of this disclosure are described in a specific ordered order for ease of illustration, it should be understood that this descriptive style includes rearrangement unless a specific order is required by the specific language described below. For example, operations described in sequence may be rearranged or performed simultaneously in some cases. Furthermore, for simplicity, the accompanying drawings may not show the various ways in which the methods of this disclosure can be combined with other methods. Additionally, the description sometimes uses terms such as “provide” or “implement” to describe the methods of this disclosure. These terms are highly abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and can be readily identified by those skilled in the art.

[0124] As used in this application and claims, the term “link” generally refers to a physical, electrical, magnetic and / or chemical connection or link, and does not exclude the presence of intermediate elements in the link or related items in the absence of specific contrasting language.

[0125] As used herein, the term "proximal" refers to the location, orientation, or portion of the device's tip or endpoint within the body that is closer to the device user / operator and further away from the patient's body (e.g., the heart). As used herein, the term "distal" refers to the location, orientation, or portion of the device's tip or endpoint within the body that is further away from the device user / operator and closer to the patient's body (e.g., the heart). Thus, for example, proximal movement of a catheter is, for instance, movement of the catheter away from the body and / or toward the operator (e.g., retraction of the catheter away from the patient's body), while distal movement of a catheter is movement of the catheter away from the operator and further into the body (e.g., insertion of the catheter toward the heart). Unless otherwise expressly defined, the terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions.

[0126] As used herein, the terms “monolithic” and “monolithic construction” refer to a construction that does not include any welding, fasteners, or other means of securing separately formed material parts to each other.

[0127] As used herein, operations that occur "simultaneously" or "synchronously" generally occur at the same time as each other, although the occurrence of one operation is delayed relative to another due to the presence of gaps, play, or backlash between components in mechanical connections such as threads, gears, etc., is clearly within the scope of the above terms—in the absence of specific contrasting language.

[0128] Given that the principles of this disclosure are applicable to a variety of possible implementations, it should be understood that the illustrated implementations are merely preferred examples and should not be considered as limiting the scope of this disclosure. Rather, the scope of this disclosure is at least as broad as the appended claims. We therefore claim that all contents falling within the scope and spirit of these claims, and their equivalents, are our inventions.

Claims

1. A maneuverable catheter assembly, comprising: A catheter having two or more traction wires that cause the catheter to bend; A control handle is connected to the catheter, the control handle comprising: A housing, the housing including a longitudinal axis extending in the distal and proximal directions; A cam component, the cam component being axially movable relative to the housing and rotatably movable relative to the housing; A universal joint mechanism that engages with the cam member such that the universal joint mechanism moves relative to the housing in response to movement of the cam member relative to the housing; The two or more traction wires are connected to the universal joint and extend distally away from the control handle and into the operable conduit to achieve bending of the conduit based on the position of the universal joint relative to the housing; A direction control, coupled to the cam member, causes the cam member to rotate to adjust the bending direction of the conduit via the two or more traction wires; and A level control, which is coupled to the cam member to adjust the level of conduit bending by axially moving the cam member relative to the housing.

2. The operable catheter assembly of claim 1, wherein the level control adjusts the catheter bending level independently of the catheter bending direction.

3. The operable catheter assembly of claim 1, wherein the direction control and the magnitude control are selected from a lever, knob, dial, or device for receiving digital input.

4. The operable catheter assembly according to any one of claims 1-3, wherein the cam member includes a protrusion, wherein the level control moves the protrusion in the axial direction of the control handle, and wherein the direction control rotates the protrusion.

5. The steerable catheter assembly of claim 4, wherein each of the two or more traction wires is coupled to a universal joint, and movement of the protrusion positions the universal joint.

6. The operable catheter assembly of claim 5, wherein the universal joint mechanism comprises a universal ring and a universal plate, wherein the universal ring is pivotally connected within the housing of the control handle, and the universal plate is pivotally connected within the universal ring.

7. The operable catheter assembly of claim 6, wherein the rolling ball is rotatably coupled to the end of the protrusion.

8. The operable catheter assembly of claim 6, wherein the traction wire is coupled to the universal joint, the protrusion contacts the universal joint, the position of the protrusion sets the orientation of the universal joint mechanism, and the orientation of the universal joint mechanism sets the position of the traction wire.

9. The operable conduit assembly of claim 4 further includes a clutch mechanism configured to selectively fix one of the axial position and rotational position of the cam member, while allowing the other of the axial position or rotational position of the cam member to change.

10. The operable catheter assembly of claim 1, wherein the control handle independently adjusts the radial bending magnitude and the circumferential angle of the catheter.

11. The steerable catheter assembly of claim 1, wherein the radial bending magnitude and the circumferential angle at which the radial bending occurs are adjusted without rotating the catheter about its longitudinal axis.

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