Elongated Steerable Device for Insertion into a Subject's Body - Patent application

Abstract

To allow a reduction in the diameter of the apparatuses without compromising functionality.SOLUTION: Elongate steerable devices for insertion into a subject's body include very narrow (small diameter) devices that may be configured as steerable catheters and guidewires for use in interventional cardiology and neuroradiology. Also described are methods of making and using these devices, and controllers for controlling these steerable devices. These steerable devices may have a bendable distal region and a plurality of tendons each attached to the distal bendable region and extending from the distal bendable region to a proximal handle region with a plurality of axial translation regions. The axial translation regions may be arranged along an outer surface of the proximal handle region and each axial translation region may be coupled to a tendon for bending the distal region. The axial translation regions may be elastically connected to each other, and configured to translate the tendon and thereby steer the distal bendable region.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 61 / 988,001, filed May 2, 2014, and entitled "ELONGATE STEERABLE DEVICES FOR INSERTION INTO A SUBJECT'S BODY."

[0002] Incorporation by Reference All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0003] Described herein are elongated, steerable, insertable devices that are extremely low profile (e.g., slim), and devices (controllers) for steering the devices. For example, described herein are steerable guidewires and catheters that can be used in interventional cardiology and neuroradiology and that can be robotically controlled. [Background technology]

[0004] The steerable guidewires and catheters described above primarily comprise one or more mechanical pull wires housed within the guidewire / catheter lumen, which can be selectively pulled from the proximal end to deflect / bend the distal tip. However, due to the complex structures required to form these devices, most have outer diameters exceeding 5 mm, with the smallest currently measuring approximately 2 mm. These devices are typically used in electrophysiology and other applications where the vessels being guided are relatively large, but are not suitable for use in interventional cardiology (IC) and neuroradiology (NR) procedures.

[0005] For example, a suitable (non-steerable) guidewire for use in IC and NR procedures is a 1F (0.014 inch or 0.36 mm) guidewire. Corresponding catheters for use with these devices have an inner diameter slightly larger than 1F to allow them to pass over the 1F guidewire. The size of IC and NR guidewires and catheters is considerably smaller than existing steerable devices because they must navigate much smaller blood vessels (approximately 0.5 mm in diameter). Summary of the Invention [Problem to be solved by the invention]

[0006] Thus, there is a need for extremely low-profile instruments (e.g., microguidewires and microcatheters) that are steerable in vivo. Described herein are instruments (e.g., devices and systems) that address those needs, methods of fabricating those instruments, and methods of operating those instruments. Any of the instruments described herein may be robotically, automatically, and / or manually steerable.

[0007] The steerable instruments, controllers, methods of making them, and methods of using them described herein may include several important features that allow for a reduction in the diameter of the instrument without compromising functionality. [Means for solving the problem]

[0008] The present invention relates generally to long, thin, steerable instruments (devices and methods) for insertion into the human body, and methods of making and using the same. In particular, the long, steerable devices described herein typically comprise an elongate body having at least one inner lumen and a tendon, or more preferably, multiple tendons, coupled at a distal end to a distal bending region (e.g., a distal tip region) and at a proximal end to a proximal axial translation region.

[0009] Generally, the proximal end can be configured to have a plurality of rows of axial translating regions, each coupled to a puller wire or tendon, such that axial movement of the axial translating regions relative to other regions of the device (e.g., pushing or pulling longitudinally in the direction of extension of the device) can cause the puller wire or tendon to move and bend the bendable distal region. The rows of axial translating regions can be connected to each other, such as by being resiliently connected to each other via springs or stretchable / compressible material.

[0010] Any of the devices described herein can be configured as a guidewire or catheter. For example, a catheter can include an internal lumen extending through all or most of the length of the device through which a material or structure (e.g., a guidewire) can be threaded. The steerable guidewires described herein may not include this additional lumen.

[0011] Generally, the elongate body of the device may be formed from a longitudinally arranged coil or multiple coils. The elongate body is generally flexible and / or bendable, so that it can be used to navigate through the body, including through vascular regions of the body. One or more distal regions of the elongate body may be steerable regions, including but not limited to the distal end of the device. In some variations, the device may include multiple steerable regions. The steerable region may have even greater flexibility / bending. One or more, typically two, three, four, five, or more, tendons may be attached to pull and / or push the bending steerable region. The distal end of each tendon is attached at or near the steerable region itself (e.g., at the distal end of the steerable region), and the proximal end of each tendon is typically attached to a proximal axial translation region. The tendons are typically retained within the elongate body. In particular, the tendons may be held at or near the radially outer region of the elongate body, particularly near the steerable distal region, and prevented from interacting with each other by a spacer or inner member.

[0012] Generally, the proximal end of the device can be configured as a handle including a number of axial translation regions corresponding to the number of tendons. The axial translation regions can be positioned annularly or partially annularly around the outer surface of the proximal handle region. The axial translation regions are configured to displace axially (distally and / or proximally) relative to the elongate body and / or each other, such that moving the axial translation regions moves (e.g., pushes or pulls) the tendons attached to the axial translation regions, thereby applying or removing bending forces to the distal steerable region. In variations where multiple axial translation regions are present, the axial translation regions can be positioned longitudinally adjacent to each other, with intervening regions (e.g., compressible / expandable regions) connecting them. Thus, the axial translation regions can be resiliently connected to each other. Each of the annular outer surface regions adapted as axial translation regions can be easily and separately clamped / unclamped by a control device holding the outer surface of the proximal end of the device. Thus, the structure can be easily threaded over (e.g., slid over) or into (passed through) the device without the need for an associated removal / reattachment procedure. Also, the control system (examples of which are also provided herein) can be relatively simple and easy to use. Alternatively, the device may be manually controlled by directly manipulating the axial translation region.

[0013] For example, described herein is an elongate steerable device for insertion into a subject's body, which may extend in a proximal-to-distal direction from a bendable distal tip region to a proximal handle region, and may include a plurality of tendons, each of which may be attached to the distal tip region, extending from the distal tip region to the proximal handle region, and a plurality of axial translation regions disposed along an outer surface of the proximal handle region, each axial translation region of the plurality of axial translation regions coupled to a tendon of the plurality of tendons, each axial translation region configured to move in a distal-to-proximal line to axially translate a tendon coupled to the axial translation region, thereby deflecting the distal tip.

[0014] Each axial translation region is configured to move in a proximal-to-distal line relative to the proximal and distal lengths of the device. Thus, each axial translation region can move back and forth in longitudinal motion to bend the distal tip region (e.g., toward the proximal end and away from the distal end, or toward the distal end and away from the proximal end). The proximal-to-distal lines described herein can be straight or non-straight (e.g., curved).

[0015] As described in more detail below, the axial translation regions may be resiliently coupled to one another and / or to a central core / slider.

[0016] Another example of an elongate steerable device for insertion into a subject's body extending in a proximal-to-distal direction from a bendable distal tip region to a proximal handle region includes a first tendon member within the device extending from the distal tip region of the device to the proximal handle region of the device, a second tendon member within the device extending from the distal tip region of the device to the proximal handle region of the device, and a first axial translation region at an outer surface of the proximal handle region, coupled to the first tendon member and The tendon includes a first axial translation region configured to move in a distal-to-proximal direction to axially translate the tendon, and a second axial translation region on an outer surface of the proximal handle region, the second axial translation region coupled to the second tendon and configured to move in a distal-to-proximal direction to axially translate the second tendon, thereby deflecting the distal tip in a second direction, the first axial translation region and the second axial translation region being elastically coupled to each other.

[0017] Another example of an elongate steerable device (extending in a proximal-to-distal direction) for insertion into a subject's body includes an elongate body having a bendable distal tip region, an intermediate region, and a proximal handle region; a first tendon extending within the elongate body of the device from the distal tip region to the proximal handle region; a second tendon extending within the elongate body of the device from the distal tip region to the proximal handle region; a first axial translation region at an outer surface of the proximal handle region of the elongate body, the first axial translation region coupled to the first tendon; and a second axial translation region at an outer surface of the proximal handle region, the second axial translation region coupled to the second tendon, the first axial translation region and the second axial translation region being elastically coupled to one another. In some variations, the instrument includes multiple translation regions (axial translation regions) that are not coupled to one another. For example, the translation region may comprise one or more tracks in the proximal handle or multiple individual slides that move in one or more guide rails.

[0018] As mentioned, any of these devices may be configured as a guidewire or as a catheter (eg, having a central lumen extending therethrough).

[0019] Generally, the axial translation regions (e.g., the first axial translation region and the second axial translation region) are adjacently disposed along the outer surface of the proximal handle region. The axial translation regions may comprise cylindrical regions adjacently disposed along the outer surface of the proximal handle region (including forming the outer surface of the device in the proximal handle region).

[0020] Generally, tendons can be wires (e.g., pull wires / push wires), rods (e.g., pull rods / push rods), strands, fibers, etc. Tendons can be attached to the distal bend (e.g., tip) region at radially offset attachment sites. In particular, tendons ("pull wires") can be multifilament (e.g., thread or string) pull wires. Tendons can also be monofilament (e.g., steel or nitinol wire). For example, a multifilament tendon may comprise an outer diameter thread of approximately 0.04 mm, including, for example, five individual fibers, each measuring about 0.01 mm.

[0021] The axial translation region can be configured to move in a distal-to-proximal direction to axially translate the coupled tendons and thereby deflect the distal tip. For example, translating a first axial translation region distally or proximally can move the first tendon and bend the distal steerable region in a first direction, and the second axial translation region is configured to move in a distal-to-proximal direction to axially translate the second tendon and thereby deflect the distal tip in a second direction. The axial translation region can also move in a proximal-to-distal direction (e.g., to restore position). In some variations, an actuator can move the axial translation region in a proximal-to-distal direction (e.g., "push" the tendon) to transfer a compressive load and deflect the tip, and actuating the axial translation region distal-to-proximal can "pull" the tendon to deflect the tip. In some embodiments, the instrument may be adapted so that only a pulling (non-compressive) force is applied by the actuator, in other variations the instrument may be adapted to apply both a compressive force and a pulling (extension) force, and in still other variations only a compressive force may be applied. Either or both the steerable device and / or the actuator may be configured to operate in either or both compression and / or extension of the tendon material.

[0022] The elongate body may generally be formed as a coil (e.g., a helical coil) and may generally include a bendable distal tip region, an intermediate region, and a proximal handle region. The elongate body may have different flexibility / flexibility along different regions of its length. For example, the elongate body may comprise coils with different pitches and / or pretension along the length of the elongate body. In particular, the handle region may include relatively stiff regions (e.g., axial translation regions) separated by flexible, elastic, or movable regions. These flexible, elastic, and / or axially extensible / compressible regions may connect adjacent axial translation regions. For example, the elongate body may include a bendable distal tip region, an intermediate region, and a proximal handle region, the elongate body having a plurality of different pitches along the length of the elongate body, and the handle may include an axial translation region formed from narrow pitch (relatively stiff) regions separated by regions having a more flexible (expandable / compressible) pitch and / or material, which may be welded or glued together.

[0023] Also described herein are methods of using these devices. For example, a method of steering an elongate device having multiple tendons, each tendon coupled to a distal tip region at a distal end of the device and coupled to a separate axial translation region at a proximal end of the device, the axial translation regions arranged along a proximal-to-distal line along a proximal handle region of the device, the axial translation regions resiliently coupled to one another, may include holding at least a first axial translation region and a second axial translation region of the axial translation regions separate, and sliding the first axial translation region proximally or distally relative to the second axial translation region to increase or decrease the distance between the first axial translation region and the second axial translation region of the axial translation regions, thereby axially translating the tendon coupled with the first axial translation region and deflecting the distal tip region.

[0024] Generally, the method can also include inserting the device into the subject's body. The separately holding step can include frictionally securing each of the axial translation regions to a separate grip of the actuator.

[0025] The method may also include sliding a first one of the axial translation regions so that the first one of the axial translation regions slides relative to a portion of the device distal or proximal to the proximal handle region while holding a portion of the device distal or proximal to the proximal handle region. The holding separately may include holding the first one of the axial translation regions with a first grip and holding the second one of the axial translation regions with a second grip. In some cases, holding each of the axial translation regions separately includes holding each of the axial translation regions with separate frictional grips that are movable independently of each other. Holding each of the axial translation regions separately may include holding a portion of the device distal to the proximal handle region and / or a portion of the device proximal to the axial translation region.

[0026] A method for manipulating an elongate device having multiple tendons, each tendon coupled to a distal tip region at a distal end of the device and coupled to a separate axial translation region at a proximal end of the device, the axial translation regions arranged along a proximal-to-distal line along a proximal handle region of the device, the axial translation regions elastically coupled to one another, the method may include the steps of frictionally securing each of the axial translation regions to a separate gripping portion of an actuator, and while holding a portion of the device distal to the proximal handle region, sliding the first axial translation region proximally or distally relative to the second axial translation region to axially translate the tendon coupled to the first axial translation region and deflect the distal tip region by increasing or decreasing the distance between a first axial translation region and a second axial translation region of the axial translation regions.

[0027] As mentioned above, a controller for controlling the bending of the distal region of the described devices is also included. The controller may be provided with these devices (e.g., as a system) or separately from the device. Generally, the controller includes one (or, more likely, a plurality, e.g., two, three, four, five, six, or more) pairs of discrete gripping surfaces that separately grip the axial translation region and / or portions of the device proximal, distal, or proximal and distal to the axial translation region such that the axial translation region can be independently actuated to drive bending of the device. Any of these controllers may be adapted for automatic, manual, or both operation. The elongated steerable device may be coupled to the controller by clamping, gripping, or other fixation to each of the axial translation region and / or other regions of the proximal end of the device.

[0028] For example, a control device adapted to independently move different axial translation regions of an elongated steerable device for insertion into a subject's body to bend the distal tip of the elongated steerable device may include two or more pairs of gripping surfaces, the two or more pairs of gripping surfaces arranged in a line extending from proximal to distal, and further wherein the distance between the gripping surfaces forming each pair of gripping surfaces is adjustable so that the elongated body can be clamped between each of the pairs of gripping surfaces, and at least one driver configured to drive translation of the pairs of gripping surfaces, the at least one driver adapted to cause each pair of gripping surfaces to translate independently of one another.

[0029] The control device may include a stabilizing pair of gripping surfaces positioned in line proximally or distally with two or more pairs of gripping surfaces, the stabilizing pair of gripping surfaces preventing axial translation of the elongated steerable device when one or more pairs of gripping surfaces are translated. In some variations, the stabilized gripping surfaces may be positioned between the axial translation regions.

[0030] The gripping surfaces described herein include pairs of gripping surfaces that compress the axial translation regions (or stabilization regions of the device) between them, although any of these variations can be adapted to use a single gripping surface (e.g., a channel, U-shape, cavity, etc.) or three or more gripping surfaces.

[0031] The at least one driver may be any suitable type of driver, including, but not limited to, a mechanical actuator (e.g., a motor), a pneumatic actuator, and an electric actuator. The driver may translate in rotation or in a linear dimension. Thus, the pair of gripping surfaces may be adapted to translate in a distal-to-proximal direction and / or to rotate in a clockwise / counterclockwise direction, etc. For example, at least one of the gripping surfaces of each pair of gripping surfaces may be configured as a roller. The driver may be configured to drive the translation of multiple pairs of gripping surfaces; for example, a single motor may be adapted to independently drive the translation of each pair of gripping surfaces.

[0032] The control device may include two or more rails and / or gantries, with each pair of gripping surfaces coupled to one of the rails / gantry and adapted to translate on the rails / gantry. In some variations, the control device may include one or more rails, with each pair of gripping surfaces coupled to one of the rails and adapted to translate on the rails.

[0033] Generally, a portion (e.g., an upper portion) of the control device is hinged, and the hinge is configured to allow the device to be inserted or removed by adjusting the distance between the gripping surfaces forming each pair of gripping surfaces. For example, the control device may include a fastener configured to secure each of two or more pairs of gripping surfaces to an elongate body held between each pair of gripping surfaces.

[0034] The controller may include a user interface adapted to control translation of each of the pair of gripping surfaces to steer the distal tip of an elongate device held between each of the pair of gripping surfaces of the controller. For example, the controller may include buttons, dials, levers, a graphical user interface, etc. to control actuation.

[0035] In any of the described control devices, the control device may include at least one limiting device configured to limit translation of the pair of gripping surfaces (eg, to less than about 5 mm).

[0036] Any of the controls (control devices) described herein may be configured as multi-part controls having two, or in some cases more, components that engage with each other, some of the components may be reusable and some of the components may be single use or limited reuse (e.g., sterilizable). For example, any of the control device instruments described herein may be configured as a control device system for steering the distal tip of an elongated steerable device (e.g., any of the elongated steerable devices described herein), including: a cartridge having two or more frictional grippers arranged in a line extending from proximally to distally, each frictional gripper configured to hold a portion of the elongated steerable device, and each frictional gripper independently movable along the line extending from proximally to distally; and a driver assembly having two or more drive members, each drive member having a coupling device configured to engage one of the frictional grippers when the cartridge is coupled with the drive assembly to drive movement in the line extending from proximally to distally, and each frictional gripper driven by one or more drive motors within the drive assembly, wherein the cartridge and driver assembly are configured to be removably coupled together through a sterile barrier.

[0037] The cartridge may be single-use (e.g., disposable) or may be regenerated (e.g., sterilized) after each use. The cartridge may be preloaded with the elongated steerable device or may be packaged separately, e.g., in sterile or sterilizable packaging. The cartridge may include a cover that covers the frictional gripper. The frictional gripper may include any pair of gripping surfaces described herein (or may include a single gripping surface, e.g., a C-shaped gripping surface). Each frictional gripper may include a gripping surface and / or a fastener and / or a fastener that clamps and securely holds a portion (e.g., a sliding element) of the elongated steerable (e.g., elongated steerable tip) device, such as a catheter and / or guidewire described herein. The frictional gripper may be retained on the cartridge (e.g., within, on, and / or in the cartridge housing) so as to be axially slidable in a distal-to-proximal axis (e.g., a line extending from distal to proximal). For example, the friction grippers may be coupled to one or more rails, tracks, or the like, and may each include a bearing surface to allow axial movement within the cartridge. Each of the friction grippers may include a coupling device for coupling with a drive member of a drive assembly. In some variations, coupling between the drive member and the friction grippers occurs through a sterile barrier, such as a sheet, bag, or pouch. The coupling device may be a magnetic coupling device, which may include a static magnet or an electromagnet. The coupling device may be contact or non-contact. The coupling device may be oriented to engage with the drive member in an orientation-specific manner. For example, for a magnetic coupling device, the orientation of the magnetic poles in the coupling device (and therefore in the friction grippers) may be positioned such that the coupling device mates with a drive member having a complementary magnetic pole orientation. In some variations, the friction grippers (including or separate from the coupling device) are keyed to only fit onto the drive member in a predetermined orientation.

[0038] The drive assembly typically includes one or more drives (e.g., motors) that move the drive members, and thus (through couplings) the friction grippers, in a proximal-to-distal line (axis). In some variations, each drive member includes or is coupled to a separate drive, allowing separate control of the axial movement of its friction grippers, and thus one of the friction grippers. In some variations, multiple drive elements may share a single drive element, but still be able to move separately, e.g., by controlling engagement with the shared drive.

[0039] In any of the controls described herein, the control may be used in a sterile field by enclosing the control at least partially within a sterile barrier, such as a sterile bag, case, sleeve, etc. For example, a multi-component control may be configured for use with a sterile barrier (e.g., a sleeve) such that a first component (e.g., a cartridge including a frictional gripper) is sterile and can be used in a sterile field, while a second component (e.g., a reusable driver assembly) is not sterile but can be held within the sterile barrier (e.g., a sleeve). The barrier may include a frame, cage, or other fixture to hold the bag on the driver assembly so that the driver assembly can securely engage the cartridge and drive movement of the frictional gripper through the sterile barrier.

[0040] For example, any of the controller systems described herein adapted to steer the distal tip of an elongated steerable device may include a cartridge having two or more frictional grippers arranged in a line extending from proximally to distally, each frictional gripper configured to grip a portion of the elongated steerable device and further wherein each frictional gripper is independently movable along the line extending from proximally to distally; and a driver assembly having two or more drive members, each drive member including a drive motor coupled to a magnetic coupling configured to magnetically engage with a first one of the frictional grippers when the cartridge is coupled with the drive assembly through a sterile barrier to drive movement of one of the frictional grippers in the line extending from proximally to distally, wherein the cartridge and driver assembly are configured to be removably coupled together through the sterile barrier.

[0041] In some variations, the controller system includes a sterile barrier (which may be configured as a bag or sleeve) within which the driver assembly fits. The sterile barrier may include a cage, frame, or other fixture within the sterile barrier within which the driver assembly fits.

[0042] As previously mentioned, the frictional gripping portions may each include a pair of gripping surfaces that can be clamped over the elongated steerable device. The frictional gripping portions may each include a securing portion configured to releasably secure a discrete portion of the elongated steerable device within the frictional gripping portion.

[0043] The driver assembly and cartridge may be held together (e.g., in some variations through a sterile barrier) by any suitable attachment mechanism. While other attachment (e.g., mechanical) mechanisms may also or alternatively be used, a magnetic attachment between the cartridge and driver assembly may be particularly useful. For example, an orienting magnetic attachment may be used between the cartridge and driver assembly to both align and secure the cartridge to the driver assembly through the sterile barrier in a predetermined alignment. Generally, the attachment between the cartridge and driver assembly may be oriented (e.g., keyed) so that the two are only connectable in a predetermined orientation.

[0044] Also described in the present specification is an elongated steerable device for insertion into a subject's body, comprising: an elongated body having a distal tip region, an intermediate region, and a proximal handle region; a plurality of tendons attached to the distal tip region and extending proximally within the elongated body, each tendon being coupled to a separate axially movable working region on the outer surface of the proximal handle region; and at least one dividing device in the distal tip region adapted to hold each of the plurality of tendons radially outward from a central core of the elongated body, the at least one dividing device adapted to prevent the tendons from entangling with each other.

[0045] For example, the steerable device may be configured as a steerable guidewire device comprising an elongate body having a distal tip region, an intermediate region, and a proximal handle region; a plurality of tendons attached to the distal tip region and extending proximally within the elongate body, each tendon being coupled to a separate axially movable working region on the outer surface of the proximal handle region; and at least one dividing device in the distal tip region adapted to hold each of the plurality of tendons radially outward from a central core of the elongate body, the at least one dividing device adapted to prevent each of the tendons from entangling.

[0046] As previously mentioned, any of these devices may include multiple tendon members (eg, 2, 3, 4, 5, 6, 7, 8, etc.).

[0047] The dividing device generally separates and applies force to the tendon material to maintain the tendon material radially outward from the midline of the device. For example, the dividing device may include at least one core member in the distal tip region, although multiple core members (segmented or connected) may be used. The core member may include a separator having regions of alternating diameter extending along the length of the core member.

[0048] In general, any of the steerable devices described herein may be thin or narrow. For example, any of these devices may have an elongate body with a diameter of less than about 1 mm (e.g., less than 0.9 mm, less than 0.8 mm, less than 0.7 mm, less than 0.6 mm, less than 0.5 mm, etc.).

[0049] In some variations, the device may include multiple steerable regions. For example, an elongate steerable device for insertion into a subject's body extending in a proximal-to-distal direction from a distal tip region to a proximal handle region may include multiple tendons, each attached to the distal bending region and extending from the distal bending region to the proximal handle region, and multiple axial translation regions disposed along an outer surface of the proximal handle region, each axial translation region of the multiple axial translation regions coupled to a tendon of the multiple tendons, the axial translation regions elastically coupled to one another and further configured to move in a distal-to-proximal direction to axially translate the tendon coupled to the axial translation region, thereby deflecting the distal bending region to which the tendon is attached.

[0050] In some variations, an elongate steerable device for insertion into a subject's body includes an elongate body having one or more distal bending regions, an intermediate region, and a proximal handle region; a plurality of tendons, each of which has a distal bending region attached to one or more tendons, each extending proximally within the elongate body, and each tendon coupled to a separate axially movable actuation region on an outer surface of the proximal handle region; and at least one dividing device in the distal bending region adapted to hold each of the plurality of tendons radially outward from a central core of the elongate body, the at least one dividing device adapted to prevent the tendons from entangling with each other. [Brief explanation of the drawings]

[0051] [Figure 1A] FIG. 1 is a diagram of an example of a device (system) configured as a long, steerable guidewire coupled to a controller to drive steering of the distal tip (or other distal region). [Figure 1B] FIG. 1 is a diagram of an example system configured as a long, steerable catheter coupled to a controller to drive steering of the distal tip (or other distal region). [Figure 2A] 1A and 1B are diagrams of examples of elongated steerable devices for insertion into a subject's body, extending in a proximal-to-distal direction from a bendable distal tip region to a proximal handle region. [Figure 2B] FIG. 2B is an enlarged cross-sectional view of the distal (tip) end region of the device of FIG. 2A. [Figure 2C] FIG. 2B is an enlarged perspective view of the distal (tip) region of the device of FIG. 2A without the distal spring. [Figure 3A] FIG. 10 is another example of a side view of a distal end region of an elongated steerable device for insertion into a subject's body configured as a steerable guidewire. [Figure 3B] FIG. 3B is a perspective view of the distal end region shown in FIG. 3A. [Figure 3C] FIG. 3B is a cross-sectional view (taken at CC' in FIG. 3A) of the device shown in FIG. 3A, taken from the distal side. [Figure 4A] 10 is another example of a side view of a distal end region of an elongated steerable device for insertion into a subject's body configured as a steerable guidewire. [Figure 4B] FIG. 4B is a perspective view of the distal end region shown in FIG. 4A. [Figure 4C] FIG. 4B is a cross-sectional view (taken at CC' in FIG. 4A) of the device shown in FIG. 4A, taken from the distal side. [Figure 4D] FIG. 10 is a perspective view of one variation of an inner core member configured as a dividing device that may be used with any of the devices described herein. [Figure 4E] FIG. 4E is a side view of the dividing device shown in FIG. 4D. [Figure 4F] FIG. 4B is an exploded view of the distal end region of the device shown in FIG. 4A. [Figure 4G] FIG. 10 is a side perspective view of another variation of a core (inner core) member configured as a multi-lumen member having a passageway or lumen for each of the tendon materials. [Figure 4H] FIG. 10 is an end perspective view of another variation of a core (inner core) member configured as a multi-lumen member having a passageway or lumen for each of the tendon materials. [Figure 5A] 1A is a diagram of one variation of the proximal end region (e.g., the handle region, which may also be referred to as an actuator region or control region) of any of the instruments described herein, showing four axial translation regions, each of which may be attached (e.g., within a coil) to tendon wires that extend to the distal flexion region. The proximal end region shown may be part of any of the device variations described, including those shown in FIGS. 1A, 1B, 2A, 3A, and 4A. [Figure 5B] FIG. 5B is a slightly enlarged view of two resiliently coupled axial translation regions similar to those shown in FIG. 5A. [Figure 5C] FIG. 10 is a diagram of a variation of an axial translation region that may be used, where the axial translation region is formed from a portion of the coil that forms the elongate body of the device and is formed by a region that has a narrower pitch than the region that it connects to. [Figure 5D]FIG. 10 illustrates a variation of an axial translation region that may be used, where the axial translation region is formed by connecting a second material (e.g., a cylinder) to a coil that forms the elongate body of the device. [Figure 5E] FIG. 10 is a diagram of a variation of the axial translation region that may be used, showing a separate region (e.g., a cylindrical region) connected to a coil at either end, such as a coil that forms the elongate body of the device. [Figure 6] FIG. 1 is a schematic diagram of a portion of a control device coupled to a proximal handle region of an elongated steerable device. [Figure 7] FIG. 1C is a partial perspective view of one variation of a control device for operating a steerable device such as that shown in FIGS. 1A-5F, showing a pair of gripping surfaces and an axial translation region clamped between them such that a driver can drive and translate both of the gripping surfaces, and thus the axial translation region, longitudinally (distally and proximally) to actuate an attachment tendon coupled to the axial translation region (not visible). [Figure 8] FIG. 1C is a partial perspective view of another variation of a control device for operating a steerable device, such as that shown in FIGS. 1A-5F, showing a pair of gripping surfaces and an axial translation region clamped between the gripping surfaces, such that a driver can drive and translate one of the gripping surfaces, and thus the axial translation region, longitudinally (distally and proximally) to actuate an attachment tendon coupled to the axial translation region (not visible). [Figure 9] FIG. 1C is a partial perspective view of another variation of a control device for operating a steerable device, such as that shown in FIGS. 1A-5F, showing a pair of rolling gripping surfaces and an axial translation region clamped between them, such that a drive device can drive rotation of the rolling surfaces to drive translation of the gripping surfaces, and thus displace the axial translation region, to actuate attachment tendons coupled to the axial translation region (not visible). [Figure 10]FIG. 1C is a partial perspective view of another variation of a control device for operating a steerable device, such as that shown in FIGS. 1A-5F, showing a pair of gripping surfaces (one rolling and one translating longitudinally) and an axial translation region clamped between the gripping surfaces, such that a drive device can drive the translation of the gripping surfaces, and thus displace the axial translation region, to actuate attachment tendons coupled to the axial translation region (not visible). [Figure 11A] FIG. 1C is a partial perspective view of another variation of a control device for operating a steerable device, such as that shown in FIGS. 1A-5F. [Figure 11B] FIG. 10 illustrates that a pair of gripping surfaces of the device are shown clamped into an axial translation region, and that a driver (e.g., a motor) can drive the translation of the gripping surfaces distally or proximally (longitudinal) to actuate attachment tendons coupled to the axial translation region (not visible). [Figure 12A] FIG. 10 is a side perspective view of one variation of a control device having multiple clamping pairs of gripping surfaces, each fixed to an axial translation region and each independently movable to actuate different building materials and steer a distal region (e.g., distal tip) of the steerable device. [Figure 12B] 12B is a cross-sectional view taken through the midline of the control device shown in FIG. 12A. [Figure 13A] 13A is an exploded partial view of another variation of a control device instrument and proximal end region of a steerable device as described herein, having four rows of axial translation regions each connected to tendons (not shown) for actuating the distal end of the steerable device. The control device shown in FIG. 13A includes multiple pairs of clamps and gripping surfaces for gripping the axial translation regions, the bottom of which is shown, and each can be independently actuated. [Figure 13B] FIG. 13B is a side view of the instrument of FIG. 13A showing the proximal end region with multiple axial translation regions of the steerable device clamped between a pair of gripping surfaces. [Figure 13C] FIG. 13B is an end view of the device of FIG. 13A. [Figure 13D] FIG. 13B is a top perspective view of the device of FIG. 13A. [Figure 13E] FIG. 18 is an exploded view of the bottom half of the device shown in FIGS. 13A-13D. [Figure 14] 10A-10C are diagrams of other examples of elongated steerable devices for insertion into a subject's body, extending in a proximal-to-distal direction from a bendable distal tip region to a proximal handle region. [Figure 15A] FIG. 15 is a detailed view of an example of an elongated steerable device (similar to that shown in FIG. 14) for insertion into a subject's body, extending in a proximal-to-distal direction from a bendable distal tip region to a proximal handle region. The overall length of this example of an elongated distally steerable apparatus is shown generally. [Figure 15B] 15B is a detailed view of an example of a long, steerable device (similar to that shown in FIG. 14) for insertion into a subject's body, extending in a proximal-to-distal direction from a bendable distal tip region to a proximal handle region, showing progressively more proximal regions in greater detail from the distal end (shown in FIG. 15B) toward the handle region shown in FIG. 15E. [Figure 15C] 15B is a detailed view of an example of a long, steerable device (similar to that shown in FIG. 14) for insertion into a subject's body, extending in a proximal-to-distal direction from a bendable distal tip region to a proximal handle region, showing progressively more proximal regions in greater detail from the distal end (shown in FIG. 15B) toward the handle region shown in FIG. 15E. [Figure 15D] 15B is a detailed view of an example of a long, steerable device (similar to that shown in FIG. 14) for insertion into a subject's body, extending in a proximal-to-distal direction from a bendable distal tip region to a proximal handle region, showing progressively more proximal regions in greater detail from the distal end (shown in FIG. 15B) toward the handle region shown in FIG. 15E. [Figure 15E] 15B is a detailed view of an example of a long, steerable device (similar to that shown in FIG. 14) for insertion into a subject's body, extending in a proximal-to-distal direction from a bendable distal tip region to a proximal handle region, showing progressively more proximal regions in greater detail from the distal end (shown in FIG. 15B) toward the handle region shown in FIG. 15E. [Figure 16A] 14 and 15A-15E, which may provide distal stiffness variation via an assembly of reinforced polymer tubes each having different bending stiffness. In this figure, throughout the figures shown, unless otherwise indicated in text, the dimensions shown are merely exemplary and may be varied (increased / reduced). [Figure 16B] 14 and 15A-15E, which may provide distal stiffness variation via an assembly of reinforced polymer tubes each having different bending stiffness. In this figure, throughout the figures shown, unless otherwise indicated in text, the dimensions shown are merely exemplary and may be varied (increased / reduced). [Figure 17A] FIG. 10 shows another example of an elongated distally steerable device. [Figure 17B] FIG. 17B is an enlarged view of the handle region at the proximal end of the device of FIG. 17A, which includes multiple sliding elements (axially translating control elements) that can be used to actuate individual tendons to steer the tip of a device as described herein. [Figure 17C] FIG. 10 is an enlarged view of a portion of the distal tip region. [Figure 17D] FIG. 10 shows a portion of the body region between the proximal handle and the distal tip, showing the laser cut hypotube. [Figure 18A] 1 illustrates an example of a multi-piece control system for actuating an elongated, distally steerable device as described herein, the multi-piece control system including separate but connectable cartridge and driver assemblies. [Figure 18B] FIG. 1 shows two components joined together to form a control device. [Figure 19A] FIG. 16 is a front perspective view of a cartridge of a multi-piece control system including an elongated steerable device. [Figure 19B]FIG. 20 shows the cartridge of FIG. 19 with the door open to show six friction grips that secure different parts of the elongated steerable device (including the sliding elements). [Figure 19C] FIG. 19C shows the cartridge of FIGS. 19A and 19B with one of the frictional grippers open, illustrating a portion of the proximal end of the elongated steerable device. [Figure 20A] FIG. 1 is a side perspective view of an example of a friction gripper as is described herein. [Figure 20B] FIG. 1 is a bottom perspective view of an example of a friction gripper as is described herein. [Figure 21A] FIG. 19B is a top view of a cartridge such as the cartridge shown in FIGS. 18A and 19A. [Figure 21B] FIG. 19B is a side view of a cartridge such as the cartridge shown in FIGS. 18A and 19A. [Figure 21C] FIG. 19B is a bottom view of a cartridge such as the cartridge shown in FIGS. 18A and 19A. [Figure 22] 18B is an exploded partial view of a drive assembly such as that in FIG. 18A, with some elements (e.g., power lines, wiring, circuitry, screws) omitted for simplicity. [Figure 23] FIG. 23 is an enlarged view of the drive members of the drive assembly shown in FIG. 22, which includes four drive members each coupled to (and / or including) a drive, driving movement of the drive members (each with a magnetic coupling device) in a proximal-to-distal axis. [Figure 24A] FIG. 10 is a top view of the drive assembly of the control device, including a protective bellows that can cover the interior of the drive assembly housing while allowing translation of the drive member. [Figure 24B] FIG. 10 is a top view of the drive assembly of the control device with the protective bellows removed. [Figure 25A] FIG. 10 is a side perspective view of one variation of the sterile cover. [Figure 25B] FIG. 25B shows the insertion of the (reusable) driver assembly portion of the control device into the sterile cover of FIG. 25A. [Figure 25C] FIG. 25D illustrates the attachment of the cartridge (including the elongated steerable member) to the coated driver assembly to form the completed control device as shown in FIG. 25D. [Figure 25D] FIG. 1 shows a completed control device. DETAILED DESCRIPTION OF THE INVENTION

[0052] Described herein are steerable catheters and guidewires for use in interventional cardiology and neuroradiology, as well as long steerable devices for insertion into a subject's body, including methods for making them, methods for using them, controllers for controlling them, and systems comprising them, particularly very narrow (small diameter) devices. Generally, these devices may have a bendable distal region (e.g., a distal tip region) and a proximal handle region, multiple tendons each attached to the distal bendable region and extending from the distal bendable region to the proximal handle region, and multiple axial translation regions in the proximal handle region. The axial translation regions may be disposed along (or form part of) the outer surface of the proximal handle region, and each axial translation region is coupled to a tendon for bending the bendable distal region. The axial translation regions may be elastically (e.g., stretchably and compressibly) coupled to one another and may be configured to move in a distal-to-proximal direction to axially translate tendons coupled to the axial translation regions and thereby steer the distal bendable region.

[0053] The long steerable devices (e.g., guidewires, catheters, etc.) described herein can generally be of any suitable length, such as, for example, between about 0.5 m and about 3.5 m. For example, a long, thin steerable catheter configured as described herein can be between about 1 m and 1.5 m in length. A long, thin steerable guidewire can be, for example, between about 1.7 m and 2.5 m in length (e.g., approximately 1.9 m in length).

[0054] As used herein, a subject can refer to any human subject, person, or animal. A subject may also be referred to as a patient. As used herein, a tendon generally comprises a flexible, relatively inelastic length of material, such as a wire, cord, or strand. For example, a tendon can be a pull wire. In some instances, a tendon has column strength that allows the tendon to be pulled as well as pushed to actuate device movement. As used herein, "adjacent" can refer to components (e.g., tendons) that are next to each other, including extending parallel to each other. Adjacent elements may, but need not, be in contact with each other. For example, adjacent tendons need not be in contact, although in some variations they may be in contact (and may be referred to as immediately adjacent) but may be separated by other elements. Similarly, adjacent axial translation regions may be closest to each other (compared to other axial translation regions) but need not be in contact with each other.

[0055] As used herein, an elongate object can refer to an object or component that is longer than it is wide (and / or high). In particular, elongate objects, including the elongate steerable devices described herein, can comprise an elongate body that is much longer in a distal-to-proximal axis than in a transverse cross-section. For example, the steerable guidewires and steerable catheters described herein comprise an elongate body that extends in a long (proximal-to-distal) axis.

[0056] As used herein, the phrase "elastically coupled" means that the elastically coupled elements are coupled such that the area between them can be stretched (e.g., stretched) or collapsed (e.g., compressed) to change the relative distance separating them. In some, but not all, variations, the elastically coupled area may be biased such that a restoring force attempts to restore the relative distance separating the two elastically coupled elements. In some examples, the elastically coupled elements are coupled such that the distance between them can be made shorter or longer without a substantial restoring force attempting to restore a predetermined separation between the two elements. Regardless of the biasing or restoring force, the space between the elastically coupled elements may be adjusted to stretch or compress the distance between the two elements, and their original separation distance (e.g., a predetermined separation distance) may be restored manually or automatically.

[0057] 1A and 1B illustrate a long, steerable device for insertion into a subject's body. In FIG. 1A, device 100 is configured as a steerable, very low-profile guidewire that may be suitable for use in interventional cardiology and / or neuroradiology procedures. The distal end of the device (distal tip region 102) is bendable, as indicated by the dotted lines, and includes multiple internal tendons (not visible in FIG. 1A). The device extends distally and proximally through an intermediate region to a proximal handle region 105, which is shown coupled to a control unit 107. The device may be formed from a coil (e.g., a helical coil).

[0058] The proximal region may comprise multiple axial translation regions (e.g., "sliders") formed in / on the elongate body at the proximal end. For example, the axial translation regions may be formed by regions of a coil having different pitches, as shown below in Figures 5A-5E. The axial translation regions may be formed by welding hypotubes to the coil or by inserting hypotubes between the coil regions.

[0059] Any of the elongate steerable devices described herein can have a coating (e.g., a hydrophilic coating). In some variations, a portion (e.g., a mid-region) of the elongate body can be a hypodermic tube (e.g., a flexible hypodermic tube). Alternatively, the entire device can be made from a single coil (e.g., a spring) that may or may not include an outer (e.g., polymeric) coating.

[0060] The distal steerable region may be small in diameter (e.g., less than 1 mm, less than 0.9 mm, less than 0.8 mm, less than 0.7 mm, less than 0.6 mm, less than 0.5 mm, etc.) and may be pliable and flexible to allow bending. Additionally, the tendon attachment sites may be separated from one another, and the tendons may be held (spaced) close to the outer wall of the elongate body along the entire bending length, each as far away from the centerline as possible.

[0061] Figure 1B shows another variation of an elongated steerable device for insertion into a subject's body. In Figure 1B, instrument 120 is configured as a catheter. Distal tip region 122 is bendable, and proximal end 125 includes multiple axial translation regions shown in control unit 107. A guidewire 127 is shown passing through the catheter.

[0062] 2A shows another variation of an elongated steerable device for insertion into a subject's body, configured as a thin steerable guidewire 200. In this example, the distal tip region is a steerable distal tip 201. The intermediate body region 203 is shortened (e.g., shown as only a few mm long, but in practice the actual length may be 1 meter or more). The proximal end comprises a sliding element (a plurality of axial translation regions 205) and an end stop 209.

[0063] The steerable tip in Figure 2A can be selectively bent by pulling on one or more of the pull wires 221. The body of the guidewire includes a hollow lumen to accommodate the pull wires, as shown in Figure 2B. At the proximal end, each pull wire is anchored to a separate axial translation region (sliding element 205) that is used to control the pull on the wire.

[0064] As previously mentioned, the pull wire (e.g., tendon) can be a wire, e.g., a pull wire / push wire, a rod (e.g., a pull rod / push rod), a strand, a fiber, or the like. The tendon can be attached to the distal bend (e.g., tip) region at radially offset attachment sites. In particular, the tendon ("pull wire") can be a multifilament (e.g., thread or string) pull wire. The tendon may also be a monofilament (e.g., steel or Nitinol wire). In some variations, multifilament tendons can have less interaction within the guidewire than monofilaments (e.g., pulling one often pulls the entire tendon) and therefore may be preferred. For example, a multifilament tendon may comprise an approximately 0.04 mm outer diameter thread containing, for example, five individual fibers, each measuring approximately 0.01 mm.

[0065] FIG. 2B shows a two-dimensional close-up of a cross section of the distal end of the device of FIG. 2A. FIG. 2C shows an isometric close-up of the same distal end with the distal spring (coil 211) hidden. In this example, the distal tip has a bendable core 215, four pull wires 221 (only two are visible in FIG. 2B), and a flexible containment coil or spring 211. The pull wires 221 are fixed to the very distal tip of the spring-like core. The core can be either a single-piece or multi-piece core and can be made from either a relatively flexible material (e.g., a polymer), a relatively stiff material (e.g., a metal), or a combination of the two. The core 215 can act as a spacer or substitute for the pull wires to ensure that the force imparted by the pull wires to the core, and more broadly, to the distal tip, acts in the correct direction to cause bending of the tip. Without a core (i.e., with only a spring or hollow flexible section), testing has shown that bending is unpredictable and inefficient. The core can also prevent kinking of the pull wire, both within the distal tip and along the body 230 of the guidewire, which could bind the wire and prevent the tip from deflecting. In some examples, the device includes a single-piece, flexible polymer core. Optionally, the core may be fixed at both ends to make tip deflection more efficient.

[0066] Figures 3A-3C show another variation of the bendable distal tip region of a device configured as a steerable guidewire. Figures 3A and 3B show the distal section of a steerable guidewire without a core. In this example, it is fabricated with split devices or spacers 301, 303, 305, and 307 (four split devices are shown), which position pull wires 322, 324, 326, and 328 in their associated quadrants and prevent them from migrating toward the centerline of the guidewire. As shown, the spacers are formed by transverse lengths of spring / coil material that form the body of the distal region. Tendon wires 322, 324, 326, and 328 pass through openings in the crossed spacers. This is evident from the distal-facing view shown in Figure 3C, taken at section C-C' in Figure 3A.

[0067] Figures 4A-4F show another variation of a bendable distal tip region of a device configured as a steerable device. The device may include a central lumen (like a steerable catheter). The device includes a multi-piece core. This device is similar to the single-piece "spinal" core shown in Figure 2B, but includes multiple pieces forming the core. This design may have greater flexibility for bending. An outer spring (coil) 403 encases the inner core and four tendons 422, 424, 426, and 428. The core holds the tendons in a radially outward position, as seen in the distal-facing cross-section shown in Figure 4C (taken at section C-C' in Figure 4A). The tendons are connected to a cap 433 at their distal ends.

[0068] An exploded view of the distal end is shown in Figure 4F, showing the outer coil region 403, tendons 422, 424, 426, 428, cap 433, and core 415. The core is formed from multiple individual core elements 417. Figure 4D shows the individual core elements in perspective and end views, respectively.

[0069] Figures 4G and 4H show another variation of a core element that can be used. In this example, the core is a multi-lumen extrusion (MLE) core, which can help separate pull wires, for example, in the distal end region. In this example, the multi-lumen extrusion core includes four transverse lumens, each capable of retaining and separating tendon material. In one example, the core has an outer diameter of approximately 0.24 mm (e.g., between about 0.1 mm and about 0.5 mm), and each of the four lumens has a diameter of approximately 0.065 mm (e.g., between about 0.050 mm and 0.09 mm). In a long steerable device including a multi-lumen extrusion 490, such as that shown in Figures 4G-4H, each lumen 499 can have a single pull wire extending therethrough. The pull wire is retained in the lumen once assembled in place. Thus, the device may comprise a multi-lumen extruded core that is approximately 30 mm in length (e.g., between 20 mm and 50 mm, between 20 mm and 40 mm, between 25 mm and 35 mm, etc.) and positioned at the very distal end of the device.

[0070] Generally, the distal section, whether it includes a core or not, is configured to be flexible to allow maximum bending and to properly direct the pull wire force and prevent the wire from tangling, so that the magnitude and direction of bending is predictable and repeatable.

[0071] In any of the instruments (which may include systems and / or devices) described herein, portions of the instrument, such as the long steerable devices described herein, may be radiopaque. For example, the distal tip region may be radiopaque. In some variations, particularly for, but not limited to, interventional cardiology use, the instrument may include an approximately 30 mm distal tip region of the guidewire that is radiopaque. For standard wires, this may typically be achieved using a platinum- or tungsten-based coil (e.g., either pure metal or alloy). In some variations, the instrument includes a radiopaque region formed using a tungsten coil. Alternatively, a platinum-based material may be used (however, in long steerable devices, it may be preferable to use a less malleable material to reduce hysteresis, such as the inability of the pull wire to spring back and "zero" the guidewire when tension is released).

[0072] 5A-5E illustrate variations of the proximal region including multiple axial translation regions disposed along the outer surface of the proximal handle region. Each axial translation region of the multiple axial translation regions is coupled to a tendon of the multiple tendons. In FIG. 5A, a portion of the proximal region includes four axial translation regions ("sliders") 503, 505, 507, and 509 elastically coupled to each other (with adjacent axial translation regions) by coil / spring regions 511, 513, and 515. FIG. 5B shows a two-dimensional close-up of a cross section of the proximal end of an example device. In FIG. 5B, each sliding element is secured to a spring at each end such that compressing / expanding the spring region between the axial translation regions allows the element to slide distally or proximally along the longitudinal axis of the device. The axial translation regions can be actuated via the application of an external force. For example, the axial translation region can be moved (actuated) manually, e.g., using fingers or tweezers; by attachment to a control device, e.g., by gripping the element with a device and moving it; by electromagnetism, e.g., by making the sliding elements out of a magnetic material and placing electromagnetic coils around them; and by electrostatics, e.g., by charging the sliding elements and causing them to repel / attract adjacent elements that are being moved.

[0073] Thus, for any of the devices described herein, the outer diameter of the device (guidewire, catheter, etc.) can remain constant, so that other devices (e.g., catheters) can be passed beyond the upper limit. In the examples shown in Figures 2A, 2B, 2C, and 5B, the entire device from proximal to distal end has an outer diameter of about 0.36 mm or less.

[0074] Figures 5C, 5D, and 5E show variations of the axial translation region that can be used. In Figure 5C, the axial translation region is a coil region having a narrower pitch than the compressible / expandable region adjacent to the axial translation region. In some variations, the coils forming the axial translation region can be welded, glued, or otherwise connected together. For example, in Figure 5D, an additional hypodermic tubing member 514 is shown attached to form the axial translation region. Alternatively, in Figure 5E, the axial translation region is formed from a separate hypodermic tubing joined to the coil region at either end. A stationary core may extend through the proximal handle region to form a guide rail (not shown) for the axial translation region to slide along, and the axial translation region may be resiliently connected to an adjacent axial translation region or to a stationary guide rail core.

[0075] Another example of a long steerable device for insertion into a subject's body is shown in FIG. 14. In FIG. 14, example dimensions are provided for illustrative purposes only; these dimensions are not intended to be limiting; alternative dimensions (or ranges of dimensions) may be used. For example, FIG. 14 shows an example of a long steerable device configured as a reinforced polymer tubing guidewire, with the device shown having a length of approximately 1900 mm, which can be divided into a 30 mm long distal tip region ("distal coil") 1403, an approximately 390 mm long reinforced polymer tubing assembly region 1405 ("variable stiffness region"), a 1330 mm long body region 1407 ("hypodermic tube body"), and a proximal handle region 1409 ("proximal coil") of approximately 150 mm. Note that the device shown is not to scale, as reflected by these approximate lengths. In FIG. 14, the distal tip 1403 can be radiopaque, as previously described, for example, by including tungsten. The variable stiffness region in this example is formed from an assembly of reinforced polymer tubing configured as described in more detail below, so that the stiffness varies from a relatively stiff proximal end (e.g., handle end) as hypotube body 1407 to a more flexible distal end. This gradual change in stiffness can prevent buckling of the device. The body region 1407 in this example is formed from hypotube (e.g., laser-cut stainless steel tubing) that can be laser cut to vary its stiffness, an example of which is shown below in FIG. 17D. The proximal end can be formed as a proximal handle (as previously described and detailed) including axial translation regions (“sliders”) 505, 507 that can be coupled to tendons and separated from each other by an intermediate coil / spring region 513 that can adjust the distance between the slides.

[0076] As previously mentioned, in FIG. 14 , the device includes a body formed from a stainless steel hypotube. In some variations (as discussed above), the body may be formed from a variable pitch / pretension spring. In FIG. 14 , the body is formed from a relatively stiff hypotube, such as 28-gauge thin-wall (“304V”) stainless steel. As shown and described later with respect to FIG. 17D , the device can be configured to provide a smooth transition between the relatively stiff hypotube and a highly flexible, atraumatic distal coil by selectively laser cutting the hypotube toward its distal end. A laser-cut helix with a varying pitch (e.g., from approximately 5 mm proximally to approximately 0.1 mm distally) can be included extending along the distal region of the hypotube (e.g., the distal 400 mm). The laser-cut hypotube can then be coupled to the distal coil. The laser-cut region at the end of the hypotube can be any suitable length (e.g., 200 mm, 300 mm, 400 mm, 500 mm, etc.).

[0077] Alternatively or additionally, a distal stiffness transition from a stiff hypodermic tube to a flexible distal coil can be formed by assembling a coil or braided reinforced polymer tube between the body and distal tip region. As an example of this configuration, FIGS. 15A-15E show a long steerable device designed using this configuration. In FIG. 15A, the overall (not to scale) area of ​​one variation of a long steerable device (e.g., configured as a steerable guidewire, catheter, etc.) is shown, including a reinforced tube subassembly (FIGS. 15C and 15D), a body region 1505, and a proximal handle region 15E (shown in more detail in FIG. 15E), as well as a flexible distal tip region 15B (shown with greater resolution in FIG. 15B).

[0078] As shown, the distal coil region 1504 may be connected to the variable stiffness region (reinforced tube subassembly 15C) by a sleeve 1507. This variable stiffness region may be formed from a combination of different regions, such as coils having different stiffnesses (durometers), such as a 55D coil, a 72D coil, a 63D coil, a 72D braid, etc. The coils may overlap and / or be connected by a sleeve.

[0079] Another similar variation is shown in Figures 16A-16B, showing only regions of varying stiffness formed as stiffening tubes. In this example, the distal coil is not shown, nor is the body region. PI / braid / 72D tube 1604 is stiff (but slightly less stiff than the subcutaneous tube body region, not shown), PI / coil / 63D tube 1606 is less stiff, 72D / coil / 72D tube 1608 is also less stiff, and 63D / coil / 40D tube 1610 is even less stiff (but slightly stiffer than the distal coil, not shown). In this example, example dimensions (in mm) are shown. For example, the 55D coil 1610 may have dimensions (in inches) of 0.0098 inch by 0.0138 inch tubing with a 0.0005 inch by 0.0025 inch coil at 150 WPI, the 72D coil may be 0.0098 inch by 0.0138 inch tubing with a 0.0005 inch by 0.0025 inch coil at 150 WPI, the PET shrink tubing (e.g., heat shrink tubing) may have a wall thickness of 0.0002 inch, the 72D PI-braided region 1604 may be 0.0098 inch by 0.0138 inch tubing with a 0.0005 inch by 0.0025 inch braid at 70 PI half load, and the 63D The PI-coil may be 0.0098" x 0.0138" tubing with a 0.0005" x 0.0025" coil at 150 WPI, and the PI-sleeve may be 0.0079" x 0.0089" tubing.

[0080] In some variations, the devices described herein may be formed using a polyamide (PI) sleeve and PET heat shrink to make the device easier to assemble. Generally, the PI sleeve may be placed inside the inner lumen to add extra support, and the PET heat shrink may be placed on the exterior to seal the inner lumen to prevent blood from entering or to ensure a smooth, sagging outer diameter for passing other devices over it.

[0081] 17A-17D show another variation of a long, steerable device having a flexible distal end (tip) that is steerable using a sliding control at a proximal handle connected to a very thin tendon, as previously described (the dimensions shown for length are merely exemplary and are in millimeters). In FIGS. 17A-17D, the varying flexibility (stiffness) near the distal end of the device is achieved by cutting (e.g., laser cutting) the hypodermic tube that forms the body. For example, the body of the device, whose distal portion is shown in more detail in FIG. 17D, is formed from laser-cut hypodermic tubes in which stainless steel tubing is helically cut to a different pitch (narrower pitches are generally more flexible and less stiff than less narrow pitch cuts) toward the distal end, which may be laser welded or otherwise attached to a distal tip formed by a coil. The tip region is shown in more detail in FIG. 17C.

[0082] The proximal handle region for steering control in this example, shown in more detail in Figure 17B, is a stainless steel coil with regions of different pitch, some of which correspond to the slider elements (sliders) previously described for coupling to and actuating the tendons to steer the tip of the device.

[0083] control device Also described herein are apparatuses (e.g., devices, systems, etc.) for controlling the actuation of linearly arranged sliding elements that actuate steering of the distal tip. For example, a system including the aforementioned device may include a controller for steering the device. Generally, the controller may be referred to as a controller, actuator, steering control, etc. For example, turning now to FIG. 6, this figure shows a schematic of one variation of a friction-based actuation system (controller). For four axial translation regions (two such sliding elements are shown), four sets of grippers (which may be referred to herein as friction grippers or simply grippers) can be used to grip the axial translation regions and selectively and independently slide the axial translation regions distally or proximally. The grippers would all be housed in a gripper assembly (or control unit). The control unit can optionally be coupled and uncoupled from the guidewire. In this manner, when the clinician wishes to steer and guide, the clinician can engage or have a controller coupled to the device. Then, when the clinician wants to pass a catheter or other delivery device over the guidewire, the clinician can disconnect the control unit. In the control system, the grippers can be actuated by independent motors housed within the control unit or by a single motor driving each of the grippers (e.g., a pair of grippers). These motors can be, for example, electromagnetic servomotors or piezoelectric motors. The use of motors (rather than manual actuation) can be advantageous, first because only a few millimeters of proximal puller wire displacement is required to bend the distal tip 90 degrees. Achieving such resolution by hand for precise guidance would be difficult. Second, the motors described herein can be programmed to maintain a commanded position via closed-loop feedback. In one example system, the clinician controls these motors and the steering of the guidewire / catheter via a user-friendly joystick interface.

[0084] In any of the example devices, the connecting region between the axial translation regions need not be a spring. In the example shown in Figure 5E, the intermediate spring region is laser welded to a 350 μm outer diameter tube (250 inner diameter), the axial translation region has an overall length (e.g., approximately 5 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, etc.), and the intermediate spring can have an overall length (e.g., 3 mm, 4 mm, 5 mm, 10 mm, 12 mm, 15 mm, 20 mm, 25 mm, etc.) when unloaded.

[0085] In any of the variations, a guide mechanism can be included as part of the device to keep the slider concentric with the centerline of the device. For example, springs can be connected to one another. Alternatively, the device can have a guide wire (or other core structure) running through the center (e.g., similar to a core wire at the distal end) and have the slider extend over this guide / core wire.

[0086] 7-11B show alternative variations of grippers that can be used with any of the control devices described herein. For example, in FIG. 7, a pair of opposing grippers can be used to clamp and control the axial translation region, as shown. One or both members of the gripper pair can be moved axially to actuate flexion / unflexion via corresponding tendons attached to the axial translation region as shown. FIG. 7 shows two frictional grippers forming a pair that runs on a smooth rail. The elements connecting the grippers to the rail are preferably made from a low-friction material (e.g., PTFE) to minimize friction with the rail (preferably mirror-polished stainless steel or the like). Each sliding element (gripping member) can include a gripping pad or surface that contacts the axial translation region of the device. The gripping pads are preferably made from a high-friction material (e.g., silicone rubber) to maximize friction with the guidewire.

[0087] In Figure 8, the gripper area is similar to that shown in Figure 7, but only one side of the gripper is directly connected to an actuator (e.g., a motor). Figure 8 therefore has only one sliding element and one set of rails. The frictional gripping force on the guidewire can be generated by clamping the guidewire between two parts (or in some variations, between a single part). The first part is the sliding element (gripping part) and the second part is the upper jaw. In Figure 8, the clamping force is generated by two screws. The clamping force can be generated by one screw or by a completely different method that does not use screws at all.

[0088] FIG. 9 shows a pair of clamping grippers configured as rollers, whose actuation can drive the axially translating region either distally or proximally within the pair of grippers. Similarly, FIG. 10 shows a hybrid gripper pair having both rollers and longitudinally translating grippers. FIG. 10 shows a sliding element (friction gripper) replaced by a rolling element. The rolling element may comprise a gripping pad (or, more precisely, a gripping tire). The rolling element may be made of a low-friction material such as PTFE and may roll directly on a polished shaft or may include bearings. For example, the rolling element may be a single ball or roller radial bearing to which the gripping tire is fitted. Alternatively, it may be a long hollow cylinder with small bearings fitted at each end. A further alternative is to press the rolling element onto the shaft and support the shaft at its ends with bearings (e.g., using a bearing stand). In this case, the rolling element may be made of any material.

[0089] 11A and 11B show a control device having a hinge region 1102 connecting the upper and lower gripping portions and allowing the control device to close the proximal end of the device so that the device can be actuated. In FIG. 11A, the control device is open, with the axial translation region of the device positioned between the upper and lower gripping portions. FIG. 11B shows the control device clamped across the axial translation region. FIGS. 7-11B show partial views of the control device and illustrate only a single pair of grippers; as previously mentioned, a control device device can include independently operable grippers capable of actuating multiple axial translation regions.

[0090] 11A and 11B, the hinge may have a spring coupled to provide either a normally open or a normally closed configuration. Thus, a user applies force to move the hinge to an unusual position. Once in the unusual position, a latch or clip (not shown) can hold the hinge in place until it is removed. Alternatively, no spring may be used at all, and clamping pressure may be provided by the user or other means. For example, a user may push the hinge closed, and the latch or clip can hold the hinge in place until the user disengages the latch or clip.

[0091] In variations with twin friction grippers, both the sliding element and / or the rolling element may be actuated, or one may be actuated while the other simply follows (as counter support) due to the transmission of actuation force via friction through the guidewire section. As previously mentioned, either of these sliding / rolling elements can be actuated manually via mechanical mechanisms (e.g., dials, pulleys, levers, gears) or via electromechanical means (e.g., actuators or motors). For example, small, precise actuators / motors may be used to provide displacement resolution and precise force control. Either of the actuators / motors may be used in a closed-loop configuration (e.g., servo) because it can provide electronic position feedback for safety and automatic position zeroing. Actuation force may be applied to the sliding / rolling elements via any means (manual, mechanical, or electromechanical) directly or through one or more intermediate elements. Examples of intermediate elements include ropes, pulleys, gears, lead screws, shafts, bearings, etc.

[0092] 12A and 12B show another variation of a control device having four independently operable gripper pairs that can be clamped and secured across the proximal end of a steerable device with four axial translation regions. In FIG. 12A, the device includes an upper region hinged 1203 to a lower region with four pairs of frictional grippers 1205 split between the upper and lower regions. The frictional grippers can be driven by a servo motor 1213 to slide the frictional grippers on sliding rails, thereby sliding the axial translation region held by a particular pair of frictional grippers either proximally or distally to flex the distal bending region. Either or both of the upper and lower regions can be enclosed within a housing 1216. FIG. 12B shows a cross-sectional view through the control device shown in FIG. 12A. In this example, the frictional grippers have a tongue-and-groove design to more securely hold the axial translation region clamped between them.

[0093] Figures 13A-13D show another variation of a hand control device for controlling the bending of a steerable device, such as those previously described (e.g., with multiple axial translation regions). In Figure 13A, a partially exploded view shows the instrument with four pairs of frictional grippers 1301, 1303, 1305, 1307 for securing to the axial translation regions at the proximal end of the device 1309. As in the variation shown in Figure 12A, frictional grippers can be secured across the device 1309 to secure the axial translation regions and make them individually controllable. This is shown in a side view in Figure 13B and an end view in Figure 13C. Figure 13D shows a top perspective view.

[0094] In any of these examples, the control device may include a single frictional gripper rather than a pair of frictional grippers. For example, the single frictional gripper may include a passageway that is approximately the same size as the device and may be formed from a material (e.g., rubber) that can be compressed around the axial translation region of the device to secure the axial translation region of the device against translation by the gripper region. As previously mentioned, the gripper region may grip the axial translation region by mechanical means (e.g., clamping, etc.) or by non-mechanical means (e.g., magnetic, electrostatic, etc.).

[0095] Generally, a friction-based gripping system with a runner / track may be used. Alternatively, a downward-running friction control may use a slider that runs on encapsulated bearings. FIG. 13E shows an exploded view of the lower half of the control device shown in FIGS. 13A-13D. In this example, gripper face 1301 rests on bearing 1355 (shown as a pair of annular bearings connected by a shaft) and slider 1344. The "gripper" may be mounted on slider 1344 (or the runner) as a high-friction pad. Base 1359, bearing housing 1361, spacers 1365, 1365', and caps 1363, 1363' may be used to secure and partially enclose the slider and gripper.

[0096] Generally, the control device may be configured as a single-use disposable control device or as a multiple-use reusable control device. Single-use disposable control devices may be supplied sterile and may be sterilized using steam (e.g., autoclaving), ethylene oxide, gamma irradiation, or other means. Multiple-use reusable control devices may be re-sterilized between subject cases. Alternatively, the control device may not be sterile and may be used with a sterile sleeve or covering. The sleeve or covering may be a single-use or reusable sleeve or covering.

[0097] Described below with reference to Figures 18A-25D are examples of multi-component control devices that can be used across a sterile barrier. For example, a portion of the control device to which an elongated steerable device, such as those described herein, can be coupled may be separate from the driver assembly and may be pre-packaged and pre-sterilized as described above, either alone or in combination with an elongated steerable device described herein (e.g., having an axially continuous sliding control at the proximal end for steering the tip region). Thus, in some variations, the cartridge portion may be used within the sterile field, and the reusable / durable driver assembly may be used outside the sterile field or enclosed behind a sterile barrier such as a sleeve, bag, or curtain. The two parts (cartridge and driver assembly) may be coupled together with a sterile barrier (e.g., unbroken) between them, but still engage side-by-side so that the cartridge can be actuated by the driver assembly through the barrier.

[0098] As previously mentioned, in any of the controllers described herein, the controller may be separated into separate interacting (interlocking) components, such as a cartridge for coupling a long steerable device (e.g., guidewire / catheter) to a driver assembly (also referred to as an actuation / control unit subassembly). The driver assembly may be a reusable, non-sterile actuation unit (which may be rendered sterile by placing a disposable sterile sleeve over the driver assembly, as previously described and illustrated herein). The driver assembly may house electronics, a motor, bearings, and the like. A separate cartridge component may engage the driver assembly and also couple with, and typically grip, the long steerable device (e.g., guidewire / catheter). This cartridge may be a disposable, sterile cartridge that also couples with an actuation unit to control the bending of the tip of the long steerable device. Figures 18A-25D help illustrate this.

[0099] For example, a disposable long steerable device may be provided already coupled to a disposable cartridge to facilitate rapid deployment: once the actuation unit is inserted into the sterile sleeve as described above, the user can couple (e.g., snap) the cartridge to the actuation unit and it is ready to be steered.

[0100] FIG. 18A shows how cartridge 1804 can be assembled (either with or without a sterile field) by coupling it with driver assembly 1806. In this example, all coupling between the cartridge and actuation unit is magnetic 1811, so it can automatically find its own alignment with the two. Additionally, the magnetic coupling / connection device can be positioned in a polarity pattern so that the two components can only engage in a predetermined orientation. However, couplings can be non-magnetic to achieve the same result, including mechanical couplings, such as snaps, clasps, etc., that can also be oriented and / or positioned to operate only in a specific, predetermined orientation. FIG. 18B shows the combined (coupled) controller 1800.

[0101] 19A and 19B are front perspective views of one variation of a cartridge 1900 portion of a system pre-loaded with a long, distally steerable device 1903, such as a guidewire / microcatheter as described herein. In this example, the device includes multiple frictional grippers 1905 that are closed (and may be releasably secured) across the long steerable device. FIG. 19C shows another example of a cartridge with one of the frictional grippers 1905 open, revealing the slider portion 1909 of the long steerable device. Any number of frictional grippers may be used, typically corresponding to the number (or number greater than one) of slider controls controlling the pull wires (tendons) in the device.

[0102] 20A and 20B show side and bottom perspective views, respectively, of the friction gripper. Generally, the friction gripper is mounted to a proximal-to-distal line of a rail, frame, or the like, and is allowed on each side (independently of each other) in the proximal-to-distal axis. Thus, when the friction gripper is fastened to the control of the slide of the elongated device, it can be actuated to steer the tip, as previously described.

[0103] In FIG. 20A, the frictional grippers are shown with a hinged upper friction surface 1412 that clamps down onto a lower friction surface, forming a pair of frictional surfaces. As previously described, these frictional surfaces can be made of a material with high grip strength for long members. The frictional grippers can include latches, locks, or other releasable mechanisms 1914 to securely hold the frictional members against the slider controls. Thus, in this example, each set of grippers has its own spring-loaded hinge and latch system. The guidewire / catheter can be quickly removed from the cartridge by opening all of the grippers. Thus, the guidewire / catheter can be optionally decoupled by positioning it between the grippers, longitudinally aligning the axial translation region with the frictional grippers, and closing all of the frictional grippers. In the example shown, each set of grippers has a high-friction silicone gripping pad (FIG. 19C, not visible in FIGS. 20A-20B) to ensure the guidewire / catheter does not slip. Also, as shown in FIG. 20B, each set of grippers may include a coupling device 2010 (eg, a magnetic coupling device) for engaging the drive member with the drive assembly.

[0104] 21A-21C show top, side, and bottom views of a cartridge assembly as previously described. In this example, coupling members (magnets) 2118 are arranged on the bottom in a pattern (e.g., a pattern of positions and magnetic poles) such that they can be aligned and coupled with a drive member in a drive assembly.

[0105] FIG. 22 shows an example of a driver assembly such as that shown in FIG. 18A in an exploded view, showing an upper housing 2208, a protective bellows 2217, four drive members 2229, and a lower housing 2209. The upper housing includes a slot through which a drive element can extend for axial (proximal-to-distal) movement. The protective bellows, when coupled to each of the grippers as described above, allows the drive members to move axially within a range for actuating the individual tendons. For example, the drive members can each be configured to move independently ±1 inch (e.g., ±0.8 inches, ±0.5 inches, ±0.4 inches, ±0.3 inches, ±0.1 inches, etc.) in the axial-to-proximal axis. The bellows can move with the drive members. In this example, each drive member is provided with a pair of magnets that are complementary to magnets in the gripping portion of the cartridge so that they are magnetically coupled, so that movement of one of the drive members results in movement of the corresponding gripping portion and therefore actuation (pushing / pulling) of the tendon material.

[0106] FIG. 23 shows an expanded view of four drive members 2301, 2302, 2303, 2304, each with and / or coupled to a dedicated drive (motor) 2321, 2322, 2323, 2324. Each drive member is also coupled to a track, rail, gantry, etc. that allows axial (distal to proximal) sliding movement. In FIG. 23, there is a common linear rail 2333 (with ball bearings, not shown). The drives in this example are four DC motors with position encoders for precise position feedback and control. The drive assembly may include four motor drives (e.g., below the linear rail 2333) and four limit switches (not visible) for position calibration at startup. The gripper is actuated via movement of a drive member (e.g., a lead screw in a motor) that drives a linear stage of the drive member that is magnetically coupled to the gripper when the cartridge is attached. Figure 24A shows another view of the protective bellows, and Figure 24B shows a top view of the drive assembly with the bellows removed.

[0107] As mentioned above, any of these devices can be used with (and include or be packaged with) a sterile barrier. For example, the reusable drive assembly portion of the controller does not need to be sterile, but may be kept within the sterile field by enclosing it within a sterile barrier, such as a sterile sleeve. This can keep the actuation / controller unit sterile during use. For example, FIG. 25A shows one variation of a (e.g., disposable) sterile sleeve 2505. This example also includes a frame or cage 2507 within the sterile sleeve to hold the drive assembly in a fixed position while it is within the sterile sleeve. For simplicity, the sleeve shown in FIGS. 25A-25D is short, but can be any length. In FIG. 25A, the cage is coupled to a standard sterile sleeve, and a flexible silicone membrane in the upper region allows the actuator grip coupling device to move freely. As shown in FIG. 25B, the actuation unit slides smoothly into the cage, and once inside, it is completely sealed off from the sterile field. Once the sleeve is positioned over the actuation unit, the cartridge can be coupled to the top as shown in Figures 25C and 25D.

[0108] In any of these examples where energy is used to operate and control the controller, the controller may be operated and controlled by hardwiring or wirelessly. Wireless controllers may include an on-board battery pack. In some variations, the controller may be coupled to a wall outlet (as shown in the example of FIG. 18A with cord 1844).

[0109] The devices described herein may have many advantages over existing guidewires and catheters, including other steerable and / or very thin (small outer diameter) devices. For example, these devices can use very few parts. In particular, these devices typically have a single lumen for the pull wire (whereas many other devices have multiple lumens) and can use a highly flexible, compliant core (through the use of polymers, multiple components, or both) to control the spatial positioning of the wire within the distal tip. This can allow the tip to deflect under the influence of applied forces. The pull wire can have any suitable diameter. For example, the pull wire can have a diameter between about 0.03 mm and 0.05 mm. However, this can limit how much tension the tendon can withstand. If the distal core included a single-piece metal structure, as disclosed in other devices, the pull wire would break before the tip could sufficiently deflect. Thus, the core region described herein is not only flexible but also controls the spatial positioning of the pull wire. The "spinal" cores described herein can be used interchangeably with very flexible bending regions with small square / round cross sections and stiffer alternative regions (with "cross" or "plus sign" cross sections). Similar multi-component cores may also be used.

[0110] The proximal coupling device for steering the devices described herein also offers several advantages. For example, because of the proximal actuation region (including the axial translation region), any of the devices described herein can easily and simply accommodate passage over / through a guidewire / catheter. As such, the coupling device can be easily and quickly attached to the exterior surface of the proximal end, allowing for actuation and deflection of the tip, but can also be quickly removed, maintaining the inner and outer diameter of the guidewire / catheter device. This contrasts with other steerable catheter systems and controls that may have large, permanent control units mounted on the exterior of the catheter that can maintain the inner diameter of the catheter, but do not allow for passage of a large catheter / introducer device over the exterior.

[0111] When features and elements are referred to herein as being "on" another feature or element, they may be directly on the other feature or element, or intervening features and / or elements may be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features and / or elements present. It is also understood that when features and elements are "coupled," "attached," or "bonded" to other features or elements, they may be directly coupled, attached, or bonded to the other feature or element, or there may be intervening features or elements present. In contrast, when a feature or element is referred to as being "directly coupled," "directly attached," or "directly bonded" to another feature or element, there are no intervening features and / or elements present. Although described or illustrated with respect to one embodiment, features and elements so described or illustrated may be applicable to other embodiments. It may be understood by those skilled in the art that references to structures or features located "adjacent" to other features may include overlapping features of the adjacent feature or may include features underlying the adjacent feature.

[0112] The terminology used herein is for the purpose of describing specific embodiments and is not intended to be limiting of the present invention. For example, as used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. It is further understood that the terms "comprises" and / or "comprising," as used herein, specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ."

[0113] Spatially relative terms such as "below," "below," "below," "above," and the like may be used herein for ease of description to describe the relationship of one element or feature to other elements or features, as shown in the figures. It is understood that spatially relative terms are intended to encompass different orientations of the device during use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures were inverted, elements described as "below" or "below" other elements or features would be oriented "above" the other elements or features. Thus, the exemplary term "below" can encompass both an above and below orientation. A device can be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptions described herein will be interpreted accordingly. Similarly, terms such as "upward," "downward," "vertical," "horizontal," and the like are used herein for descriptive purposes only, unless specifically indicated otherwise.

[0114] Although the terms "first" and "second" may be used herein to describe various features / elements, these features / elements should not be limited by these terms unless the context dictates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element detailed below could be referred to as a second feature / element, and similarly, a second feature / element detailed below could be referred to as a first feature / element without departing from the teachings of the present invention.

[0115] Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprises" and variations such as "comprising" mean that various components may be used jointly in methods and articles (e.g., compositions and apparatuses, including devices and methods). For example, the term "comprising" is to be understood to imply the inclusion of any stated element or step but without the exclusion of any other element or step.

[0116] As used herein in the specification and claims, including in the examples, unless expressly specified otherwise, all numbers may be read as if preceded by the word "about" or "approximately," even if not explicitly stated otherwise. The terms "about" or "approximately" may be used when describing a magnitude and / or location to indicate that the stated value and / or location is within a reasonably expected range of values ​​and / or locations. For example, a numerical value may have a value that is ±0.1% of the stated value (or range of values), ±1% of the stated value (or range of values), ±2% of the stated value (or range of values), ±5% of the stated value (or range of values), ±10% of the stated value (or range of values), etc. Any numerical range recited herein is intended to include all sub-ranges incorporated therein.

[0117] While various exemplary embodiments have been described above, any of several modifications may be made to the various embodiments without departing from the scope of the invention as set forth in the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be omitted entirely. Optional features of the various device and system embodiments may be included in some embodiments but not in other embodiments. As such, the foregoing description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as set forth in the claims.

[0118] The examples and illustrations contained herein show, by way of example, not limitation, specific embodiments in which the subject matter may be practiced. As noted above, other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such embodiments of the inventive subject matter may be referred to herein, individually or collectively, by the term "invention," merely for convenience, and without any attempt to spontaneously limit the scope of this application to any single invention or inventive concept, in fact, when more than one is disclosed. Thus, while specific embodiments have been shown and described herein, any configurations conceived to achieve the same purpose may be substituted for the particular embodiments shown. This disclosure is intended to cover all applications or variations of the various embodiments. Combinations of the foregoing embodiments with other embodiments not specifically described herein will be apparent to those skilled in the art upon reviewing the foregoing description.

[0119] Furthermore, the present invention preferably includes the following examples. [Section 1] 1. An elongated steerable device for insertion into a subject's body, the elongated steerable device extending from a bendable distal tip region to a proximal handle region, the elongated steerable device comprising: a plurality of tendons, each attached to the distal tip region and extending from the distal tip region to the proximal handle region; a plurality of axial translation regions arranged consecutively along an outer surface of the proximal handle region, each axial translation region of the plurality of axial translation regions being coupled to a tendon member of the plurality of tendons; Equipped with an elongated steerable device, wherein each axial translation region is configured to move in a proximal-to-distal line to axially translate the tendons coupled to the axial translation region, thereby deflecting the distal tip; [Section 2] 1. An elongated steerable device for insertion into a subject's body, the elongated steerable device extending from a bendable distal tip region to a proximal handle region, the elongated steerable device comprising: a first tendon extending within the device from the distal tip region of the device to the proximal handle region of the device; a second tendon extending within the device from the distal tip region of the device to the proximal handle region of the device; a first axial translation region on an outer surface of the proximal handle region, the first axial translation region coupled to the first tendon and configured to move in a proximal-to-distal line to axially translate the first tendon; a second axial translation region on the outer surface of the proximal handle region, the second axial translation region coupled to the second tendon and configured to move in the proximal-to-distal line to axially translate the second tendon; Equipped with The elongate steerable device, wherein the first axial translation region and the second axial translation region are resiliently coupled to one another. [Section 3] 1. An elongate steerable device for insertion into a subject's body, comprising: an elongate body having a bendable distal tip region, an intermediate region, and a proximal handle region; a first tendon extending within the elongate body of the device from the distal tip region to the proximal handle region; a second tendon extending within the elongate body of the device from the distal tip region to the proximal handle region; a first axial translation region at an outer surface of the proximal handle region of the elongate body, the first axial translation region being coupled to the first tendon; a second axial translation region at the outer surface of the proximal handle region of the elongate body, the second axial translation region being coupled to the second tendon; Equipped with The elongate steerable device, wherein the first axial translation region and the second axial translation region are resiliently coupled to one another. [Section 4] Item 1. The device of item 1, wherein the axial translation regions are resiliently coupled to one another. [Section 5] Item 1. The device of item 1, wherein the axial translation region is connected to a core material within the proximal handle region. [Section 6] 4. The device of any one of paragraphs 1 to 3, wherein the device is configured as a guidewire. [Section 7] 4. The device of any one of paragraphs 1 to 3, wherein the device is configured as a catheter having a central lumen extending therethrough. [Section 8] Item 4. The device of item 2 or 3, wherein the first axial translation region and the second axial translation region are arranged in linear succession along the outer surface of the proximal handle region. [Section 9] 4. The device of any one of paragraphs 1 to 3, wherein the axial translation region comprises a cylindrical region disposed adjacently along the outer surface of the proximal handle region. [Section 10] Item 14. The device of item 1, wherein each tendon of the plurality of tendons is attached to the distal tip region at a radially offset attachment site. [Section 11] Item 4. The device of item 2 or 3, wherein the first tendon material and the second tendon material are attached to the distal tip region at radially offset attachment sites. [Section 12] 4. The device of claim 2 or 3, wherein the first axial translation region is configured to move in the proximal to distal line to axially translate the first tendon material, thereby deflecting the distal tip in a first direction, and the second axial translation region is configured to move in the proximal to distal line to axially translate the second tendon material, thereby deflecting the distal tip in a second direction. [Section 13] 4. The device of any one of paragraphs 1 to 3, wherein the tendon comprises a multifilament wire. [Section 14] Item 3. The device of item 1 or 2, further comprising an elongate body including the bendable distal tip region, an intermediate region, and the proximal handle region. [Section 15] 4. The device of paragraph 3, wherein the elongate body comprises a hypodermic tube that is cut at its distal end region to increase its flexibility. [Section 16] Item 3. The device of item 1 or 2, further comprising an elongate body including the bendable distal tip region, an intermediate region, and the proximal handle region, the elongate body comprising a hypodermic tube. [Section 17] 1. A method of steering an elongate device having a plurality of tendons, each tendon coupled to a distal tip region at a distal end of the device and to a separate axial translation region at a proximal end of the device, the axial translation regions being arranged along a proximal handle region of the device in a proximal-to-distal line, the method comprising: maintaining at least a first axial translation region and a second axial translation region separate from one another; sliding the first axial translation region proximally or distally relative to the second axial translation region to increase or decrease a distance between the first axial translation region and the second axial translation region of the axial translation region, thereby axially translating the tendon coupled to the first axial translation region and deflecting the distal tip region; A method comprising: [Section 18] Item 18. The method of item 17, further comprising inserting the device into the subject's body. [Section 19] 18. The method of clause 17, wherein the step of separately holding comprises frictionally securing each of the axial translation regions to a separate gripping portion of an actuator. [Section 20] 18. The method of claim 17, further comprising the step of sliding the first of the axial translation regions while holding a portion of the device distal or proximal to the proximal handle region such that the first of the axial translation regions slides relative to the portion of the device distal, proximal, or distal and proximal to the proximal handle region. [Section 21] Item 18. The method of item 17, wherein the separately holding step includes holding the first axial translation region of the axial translation regions with a first grip and holding the second axial translation region of the axial translation regions with a second grip. [Section 22] 18. The method of clause 17, wherein separately holding each of the axial translating regions comprises holding each of the axial translating regions in separate friction grips that are movable independently of each other. [Section 23] Item 18. The method of item 17, wherein the step of separately holding each of the axial translation regions includes holding either or both of a portion of the device distal to the proximal handle region and / or a portion of the device distal to the axial translation region. [Section 24] 1. A method of steering an elongate device having a plurality of tendons, each tendon coupled to a distal tip region at a distal end of the device and to a separate axial translation region at a proximal end of the device, the axial translation regions being arranged along a proximal handle region of the device in a proximal-to-distal line, the method comprising: frictionally securing each of the axial translation regions to a separate gripping portion of an actuator; while holding a portion of the device distal to the proximal handle region, sliding the first axial translation region proximally or distally relative to the second axial translation region to increase or decrease the distance between a first axial translation region and a second axial translation region of the axial translation regions, thereby axially translating the tendon coupled to the first axial translation region and deflecting the distal tip region. A method comprising: [Section 25] 1. A control device adapted to independently move different axial translation regions of an elongated steerable device for insertion into a body of a subject to bend a distal tip of the elongated steerable device, the control device comprising: two or more pairs of gripping surfaces, the two or more pairs of gripping surfaces being arranged in a line extending from proximally to distally, and further wherein the distance between the gripping surfaces forming each of the pairs of gripping surfaces is adjustable such that an elongated body can be clamped between each of the pairs of gripping surfaces; at least one driver configured to drive translation of said pair of gripping surfaces, wherein each of said pair of gripping surfaces is adapted to translate independently of one another; A control device comprising: [Section 26] 26. The control device of claim 25, further comprising a stabilizing pair of gripping surfaces positioned in line proximally or distally with the two or more pairs of gripping surfaces, the stabilizing pair of gripping surfaces preventing axial translation of the elongated steerable device when the gripping surfaces are translated. [Section 27] 26. The control device of clause 25, wherein the at least one drive device comprises a motor. [Section 28] 26. The control device of clause 25, wherein the at least one drive device comprises a motor with closed-loop position feedback. [Section 29] Item 26. The control device of clause 25, wherein the at least one drive device comprises an actuator selected from the group consisting of a mechanical actuator, a pneumatic actuator, and an electric actuator. [Section 30] 26. The control device of clause 25, wherein the pair of gripping surfaces is adapted to translate along the proximal to distal line. [Section 31] Item 26. The control device of item 25, wherein at least one of the gripping surfaces of each pair of gripping surfaces is configured as a roller. [Section 32] Item 26. The control device of item 25, further comprising two or more rails, each of the pair of gripping surfaces coupled to one of the rails and adapted to translate on the rails. [Section 33] Item 26. The control device of item 25, further comprising a hinge configured to adjust the distance between the gripping surfaces forming each of the pairs of gripping surfaces. [Section 34] Item 26. The control device of item 25, wherein the at least one drive device configured to drive the translation of the pair of gripping surfaces comprises a single motor adapted to independently drive the translation of each of the pair of gripping surfaces. [Section 35] Item 26. The control device of item 25, further comprising a fastener configured to secure each of the two or more pairs of gripping surfaces to an elongate body held between each of the pairs of gripping surfaces. [Section 36] The control device described in clause 25, further comprising a user interface adapted to control the translation of each of the pair of gripping surfaces to steer the distal tip of an elongate device held between each of the pair of gripping surfaces of the control device. [Section 37] Item 26. The control device of item 25, further comprising at least one limiting device configured to limit the translation of the pair of gripping surfaces to less than about 5 mm. [Section 38] 1. An elongate steerable device for insertion into a subject's body, comprising: an elongate body having a distal tip region, a middle region, and a proximal handle region; a plurality of tendons attached to the distal tip region and extending proximally within the elongate body, each tendon being coupled to a separate axially movable actuation region on an outer surface of the proximal handle region; at least one dividing device in the distal tip region adapted to hold each of the plurality of tendons radially outward from a central core of the elongated body; Equipped with The at least one dividing device is adapted to prevent entanglement of the tendons. [Section 39] an elongate body having a distal tip region, a middle region, and a proximal handle region; a plurality of tendons attached to the distal tip region and extending proximally within the elongate body, each tendon coupled to a separate cylindrical, axially movable working region of a plurality of cylindrical, axially movable working regions arranged in a line on an outer surface of the proximal handle region; at least one dividing device in the distal tip region adapted to hold each of the plurality of tendons radially outward from a central core of the elongated body; Equipped with A steerable guidewire device, wherein the at least one dividing device is adapted to prevent entanglement of each of the tendons. [Section 40] 40. The device of claim 38 or 39, wherein the plurality of tendons comprises four tendons. [Section 41] 40. The device of claim 38 or 39, wherein the at least one dividing device comprises at least one core member within the distal tip region. [Section 42] 40. The device of claim 38 or 39, wherein the at least one dividing device comprises a core member comprising a multi-lumen core member, each tendon member of the plurality of tendon members being in a separate lumen of the multi-lumen core member. [Section 43] 40. The device of paragraph 38 or 39, wherein the elongate body has a diameter of less than about 1 mm. [Section 44] 40. The device of claim 38 or 39, wherein the elongate body comprises a hypodermic tube having one or more cut regions near the distal end. [Section 45] 40. The device of claim 38 or 39, wherein the working regions are each at least partially circumferential and aligned along the longitudinal axis of the proximal handle region. [Section 46] 40. The device of claim 38 or 39, wherein the actuation region comprises a cylindrical region arranged adjacently in a line along the outer surface of the proximal handle region. [Section 47] 40. The device of claim 38 or 39, wherein each tendon of the plurality of tendons is attached to the distal tip region at a radially offset attachment site. [Section 48] 40. The device of claim 38 or 39, wherein the plurality of tendons comprises four tendons arranged in parallel along the length of the device spaced at 90 degrees of radial rotation, each tendon creating bending of the device in an orthogonal direction. [Section 49] 40. The device of claim 38 or 39, wherein the plurality of tendons comprises three or more tendons arranged parallel and equally radially spaced from one another along the length of the device. [Section 50] 1. An elongated steerable device for insertion into a subject's body, the elongated steerable device extending from a distal tip region to a proximal handle region, the elongated steerable device comprising: a plurality of tendons, each attached to a distal bend region and extending from the distal bend region to the proximal handle region; a plurality of axial translation regions disposed along an outer surface of the proximal handle region, each axial translation region of the plurality of axial translation regions being coupled to a tendon of the plurality of tendons; Equipped with an elongated steerable device, wherein each axial translation region is configured to move in a proximal-to-distal line to axially translate the tendons coupled to the axial translation region, thereby deflecting the distal bending region to which the tendons are attached. [Section 51] 1. An elongate steerable device for insertion into a subject's body, comprising: an elongate body having one or more distal bending regions, an intermediate region, and a proximal handle region; a plurality of tendons, each having a distal bend region attached to one or more tendons, each of the tendons extending proximally within the elongate body, each tendon coupled to a separate axially movable actuation region on an outer surface of the proximal handle region; at least one dividing device in a distal bend region, the dividing device adapted to hold each of the plurality of tendons radially outward from a central core of the elongate body; Equipped with The at least one dividing device is adapted to prevent entanglement of the tendons. [Section 52] 1. A controller system adapted to steer a distal tip of an elongated steerable device, comprising: a cartridge comprising two or more frictional gripping portions arranged in a line extending from proximal to distal, each frictional gripping portion configured to hold a portion of the elongated steerable device, and each frictional gripping portion independently movable along the line extending from proximal to distal; a drive assembly including two or more drive members, each drive member including a coupling configured to engage one of the friction grippers when the cartridge is coupled with the drive assembly to drive movement in the line extending from proximal to distal, and further wherein each friction gripper is driven by one or more drive motors within the drive assembly; Equipped with A controller system configured such that the cartridge and the driver assembly are removably coupled together through a sterile barrier. [Section 53] 1. A controller system adapted to steer a distal tip of an elongated steerable device, comprising: a cartridge comprising two or more frictional gripping portions arranged in a line extending from proximal to distal, each frictional gripping portion configured to grip a portion of the elongated steerable device, and each frictional gripping portion independently movable along the line extending from proximal to distal; a driver assembly comprising two or more drive members, each drive member comprising a drive motor coupled to a magnetic coupling configured to magnetically engage one of the frictional grippers when the cartridge is coupled to the drive assembly through a sterile barrier to drive movement of the one of the frictional grippers in the line extending from proximally to distally; Equipped with A controller system configured such that the cartridge and the driver assembly are removably coupled together through the sterility barrier. [Section 54] 54. The control device system of claim 52 or 53, wherein the cartridge is pre-loaded with the elongated steerable device. [Section 55] Item 54. The control device system of item 52 or 53, wherein the cartridge is disposable. [Section 56] Item 54. A control device system as described in item 52 or 53, wherein the drive assembly is reusable. [Section 57] 54. The control device system of claim 52 or 53, further comprising a sterile barrier configured as a bag or sleeve into which the drive device assembly fits. [Section 58] 54. The control device system of claim 52 or 53, further comprising a sterile barrier configured as a bag or sleeve, and a cage within the sterile barrier into which the drive device assembly fits. [Section 59] 54. The control device system of claim 52 or 53, wherein the friction gripping portions each comprise a pair of gripping surfaces that can be clamped across the elongated steerable device. [Section 60] 54. The control device system of claim 52 or 53, wherein the frictional gripping portions each comprise a securing portion configured to releasably secure a discrete portion of the elongated steerable device within the frictional gripping portion. [Section 61] 54. The control device system of claim 52 or 53, further comprising a magnetic attachment between the cartridge and the drive assembly configured to secure the cartridge to the drive assembly through the sterile barrier. [Section 62] 54. The control device system of claim 52 or 53, further comprising an orienting magnetic attachment between the cartridge and the drive assembly configured to align and secure the cartridge to the drive assembly through the sterile barrier in a predetermined alignment. [Section 63] Item 53. The control system of item 52, wherein each friction gripper is driven by a separate drive motor. [Section 64] Item 53. The control device system of item 52, wherein each coupling device is a magnetic coupling device configured to magnetically engage with the one of the friction gripping portions. [Explanation of symbols]

[0120] 100 devices 102 Distal tip region 105 Proximal Handle Region 107 Control device 120 equipment 122 Distal tip region 125 proximal end 200 Guidewire 201 Steerable Distal Tip 203 Middle body region 205 Axial translation area, sliding element 209 End stop 211 Coils and springs 215 Flexible core material 221 Pull Wire 301, 303, 305, 307 Dividers, spacers 322, 324, 326, 328 Pull wire, tendon wire 403 Outer spring (coil), outer coil area 415 Core material 417 Core Elements 422, 424, 426, 428 tendon material 433 Cap 490 Multi-lumen Extrusion 503, 505, 507, 509 Axial translation area, sliding part 511, 513, 515 Coil / Spring Area 1102 Hinge Area 1203 hinged 1205 Friction gripping part pair 1213 Servo motor 1216 Case 1309 Devices 1301, 1303, 1305, 1307 Friction gripping part pair 1355 bearings 1344 Sliding part 1403 Distal tip region, distal coil 1405 Assembly area, variable stiffness area 1407 Body area, hypodermic tube body 1409 Proximal handle region, proximal coil 1412 Upper friction surface 15B Distal tip region 15C Variable Stiffness Region, Reinforced Tube Subassembly 15E Proximal handle region 1504 Distal Coil Region 1505 Body area 1604 PI / braid / 72D tube 1606 PI / Coil / 63D Tube 1608 72D / Coil / 72D Tube 1610 63D / coil / 40D tube 1800 Control Device 1804 cartridge 1806 Drive assembly 1844 Code 1900 cartridges 1903 Long distally steerable device 1905 Friction grip part 1914 Hasps, fasteners and other releasable mechanisms 2010 Coupling device 2118 Coupling members, magnets 2208 Upper case 2209 Lower case 2217 Protective bellows 2229 Driving member 2321, 2322, 2323, 2324 Drive unit, motor 2333 Linear Rail 2505 Sterile Sleeve 2507 Frame, Cage

Claims

1. 1. A control device for controlling bending of a distal tip region of an elongated steerable device for insertion into a body of a subject, the control device comprising: an elongated body; a plurality of axially connected axial translation regions; and a plurality of tendons connecting a distal tip region of the elongated body to separate axial translation regions, the control device being adapted to independently move different axial translation regions of the elongated steerable device to bend the distal tip of the elongated steerable device, two or more pairs of gripping surfaces, the two or more pairs of gripping surfaces being arranged in a line extending from proximally to distally, and further wherein the distance between the gripping surfaces forming each of the pairs of gripping surfaces is adjustable such that an elongated body can be clamped between each of the pairs of gripping surfaces; at least one driver configured to drive translation of said pair of gripping surfaces, wherein each of said pair of gripping surfaces is adapted to translate independently of one another; Equipped with the two or more pairs of gripping surfaces are configured to separately grip at least a first region and a second region of the axial translation region; the at least one driver is configured to slide the first region proximally or distally relative to the second region to increase or decrease a distance between the first region and the second region and to axially move tendons coupled to the first region to bend the distal tip region; A control device wherein each of the plurality of tendons is attached to the distal tip region at radially offset attachment sites.

2. 10. The control device of claim 1, further comprising a stabilizing pair of gripping surfaces positioned in line proximally or distally with the two or more pairs of gripping surfaces, the stabilizing pair of gripping surfaces preventing axial translation of the elongated steerable device when translation of the pair of gripping surfaces is actuated.

3. The control device of claim 1 , wherein the at least one drive device comprises a motor.

4. The controller of claim 1 , wherein the at least one drive comprises a motor with closed-loop position feedback.

5. The control device of claim 1 , wherein the at least one drive device comprises an actuator selected from the group consisting of a mechanical actuator, a pneumatic actuator, and an electric actuator.

6. The control device of claim 1 , wherein the pair of gripping surfaces is adapted to translate along the proximal-to-distal line.

7. The control device of claim 1 , wherein at least one of the gripping surfaces of each pair of gripping surfaces is configured as a roller.

8. The control device of claim 1 , further comprising two or more rails, each of the pair of gripping surfaces coupled to one of the rails and adapted to translate on the rails.

9. The control device of claim 1 , further comprising a hinge configured to adjust the distance between the gripping surfaces forming each of the pairs of gripping surfaces.

10. 10. The control device of claim 1, wherein the at least one drive configured to drive translation of the pair of gripping surfaces comprises a single motor adapted to independently drive translation of each of the pair of gripping surfaces.

11. The control device of claim 1 , further comprising a fastener configured to secure each of the two or more pairs of gripping surfaces to an elongate body held between each of the pairs of gripping surfaces.

12. The control device of claim 1, further comprising a user interface adapted to control translation of each of the pair of gripping surfaces to steer a distal tip of an elongate device held between each of the pair of gripping surfaces of the control device.

13. The control device of claim 1 , further comprising at least one limiting device configured to limit the translation of the pair of gripping surfaces to less than about 5 mm.

14. 1. A controller system for controlling bending of a distal tip region of an elongated steerable device adapted to steer a distal tip of the elongated steerable device comprising an elongated body, a plurality of axially connected axial translation regions, and a plurality of tendons connecting the distal tip region of the elongated body to separate axial translation regions, the controller system comprising: a cartridge comprising two or more frictional gripping portions arranged in a line extending from proximal to distal, each frictional gripping portion configured to hold a portion of the elongated steerable device, and each frictional gripping portion independently movable along the line extending from proximal to distal; a driver assembly including two or more drive members, each drive member including a coupling configured to engage one of the friction grippers when the cartridge is coupled with the driver assembly to drive movement in the line extending from proximal to distal, and each friction gripper driven by one or more drive motors within the driver assembly; Equipped with the cartridge and the driver assembly are configured to be removably coupled together through a sterile barrier; the two or more friction gripping portions are configured to separately grip at least a first region and a second region of the axial translation region; the driver assembly is configured to slide the first region proximally or distally relative to the second region to increase or decrease the distance between the first region and the second region and axially move tendons coupled to the first region to bend the distal tip region; A controller system wherein each of the plurality of tendons is attached to the distal tip region at radially offset attachment sites.

15. 1. A controller system for controlling bending of a distal tip region of an elongated steerable device adapted to steer a distal tip of the elongated steerable device comprising an elongated body, a plurality of axially connected axial translation regions, and a plurality of tendons connecting the distal tip region of the elongated body to separate axial translation regions, the controller system comprising: a cartridge comprising two or more frictional gripping portions arranged in a line extending from proximal to distal, each frictional gripping portion configured to grip a portion of the elongated steerable device, and each frictional gripping portion independently movable along the line extending from proximal to distal; a driver assembly including two or more drive members, each drive member including a drive motor coupled to a magnetic coupling configured to magnetically engage one of the frictional grippers when the cartridge is coupled to the driver assembly through a sterile barrier to drive movement of the one of the frictional grippers in the line extending from proximally to distally; Equipped with the cartridge and the driver assembly are configured to be removably coupled together through the sterility barrier; the two or more friction gripping portions are configured to separately grip at least a first region and a second region of the axial translation region; the driver assembly is configured to slide the first region proximally or distally relative to the second region to increase or decrease the distance between the first region and the second region and axially move tendons coupled to the first region to bend the distal tip region; A controller system wherein each of the plurality of tendons is attached to the distal tip region at radially offset attachment sites.

16. 16. The controller system of claim 14 or 15, wherein the cartridge is pre-loaded with the elongated steerable device.

17. 16. A control device system according to claim 14 or 15, wherein the cartridge is disposable.

18. 16. A controller system according to claim 14 or 15, wherein the drive assembly is reusable.

19. 16. The controller system of claim 14 or 15, further comprising a sterility barrier configured as a bag or sleeve into which the driver assembly fits.

20. 16. The controller system of claim 14 or 15, further comprising a sterile barrier configured as a bag or sleeve, and a cage within the sterile barrier into which the driver assembly fits.

21. 16. The controller system of claim 14 or 15, wherein the friction grippers each comprise a pair of gripping surfaces that can be clamped over the elongated steerable device.

22. 16. The controller system of claim 14 or 15, wherein the frictional grippers each comprise a securing portion configured to releasably secure a discrete portion of the elongated steerable device within the frictional gripper.

23. 16. The controller system of claim 14 or 15, further comprising a magnetic attachment between the cartridge and the driver assembly configured to secure the cartridge to the driver assembly through the sterility barrier.

24. 16. The controller system of claim 14 or 15, further comprising an orienting magnetic attachment between the cartridge and the driver assembly configured to align and secure the cartridge to the driver assembly through the sterile barrier in a predetermined alignment.

25. 15. The controller system of claim 14, wherein each friction gripper is driven by a separate drive motor.

26. 15. The controller system of claim 14, wherein each coupling device is a magnetic coupling device configured to magnetically engage the one of the friction gripping portions.

Images