WO2025038617A1

WO2025038617A1 - Steerable surgical instruments

Info

Publication number: WO2025038617A1
Application number: PCT/US2024/042071
Authority: WO
Inventors: Ian Christopher ODLAND; Tyree D WILLIAMS; Joseph BORRELLO; Tanvir F CHOUDHRI; Eugene Ivan HRABARCHUK
Original assignee: Icahn School of Medicine at Mount Sinai
Current assignee: Icahn School of Medicine at Mount Sinai
Priority date: 2023-08-14
Filing date: 2024-08-13
Publication date: 2025-02-20
Anticipated expiration: 2026-02-14

Abstract

A steerable surgical instrument includes a drive mechanism for driving a working distal end of the surgical instrument. The drive mechanism includes an inner drive shaft that is rotatable by a user resulting in rotation of the working distal end. The steerable surgical instrument further includes an angle selector mechanism that is configured to angularly displace the working distal end of the surgical instrument relative to a primary axis that comprises a longitudinal axis of the surgical instrument. The angle selector mechanism includes an outer shaft that surrounds the inner drive shaft, the outer shaft being independently rotatable by the user relative to the inner drive shaft to angularly displace the distal working end of the surgical instrument.

Description

^ Steerable Surgical Instruments Cross Reference to Related

The present application claims priority to and the benefit of US patent application ^^ Serial No.63/519,325, filed August 14, 2024, which is hereby expressly incorporated by reference in its entirety. Technical Field The present disclosure is directed to surgical instruments and more particularly, is ^^^ directed to steerable surgical instruments each of which provides a user, such as a surgeon, two intraoperative degrees of freedom, namely, (1) rotation about a primary axis that allows a torque action downstream of the user applying an upstream rotational force for driving a fastener, a tool bit or the like^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^that allows the user to drive the fastener or tool bit or position a surgical tool at a prescribed angle in either direction ^^^ from the primary axis. Various surgical procedures utilize one or more fasteners that are attached within the patient. The fasteners include a shaft that is inserted into a support member such as an ^^^ implant, bone, or tissue. The fastener further includes a head positioned at an end of the shaft that includes a receiver for engagement with a surgical instrument, e.g., a surgical screwdriver. The shaft may include threads to assist in inserting the screw into the support member and in preventing the screw from backing out of the support member. The head may include a variety of different receivers with different shapes and sizes depending upon the ^^^ context of use. One of the most common applications for a surgical screwdriver is to insert bone screws within the patient. The screwdriver includes a tip that engages the receiver and a shaft to rotate the fastener and drive it into the support member. The screwdriver may further include a handle that is grasped and rotated by the surgeon to insert the fastener into the support member. ^^^ While conventional surgical screwdrivers are satisfactory for some applications, there are many applications in which a rigid, straight surgical screwdriver cannot drive the fastener in an optimal manner. For example, anatomical constraints can prevent the screwdriver from easily accessing the surgical site at which one or more surgical screws are to be implanted. Therefore what is needed is a steerable surgical instrument, such as a surgical screwdriver,

{02420/012010-WO0/03704276.1} ^ that allows the fastener to be driven at a selected angle relative to the longitudinal axis of the surgical instrument. Summary ^^ Steerable surgical instruments are disclosed each of which provides a user, such as a surgeon, two intraoperative degrees of freedom, namely, (1) rotation about a primary axis that allows a torque action downstream of the user applying an upstream rotational force for driving a fastener or tool bit or the like^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^that allows the user to drive the fastener or tool bit or position a surgical tool at a prescribed angle in ^^^ either direction from the primary axis. In one embodiment, a steerable surgical instrument includes a drive mechanism for driving a working distal end of the surgical instrument. The drive mechanism includes an inner drive shaft that is rotatable by a user. The steerable surgical instrument further includes an angle selector mechanism that is configured to angularly displace the working distal end of ^^^ the surgical instrument relative to a primary axis that comprises a longitudinal axis of the surgical instrument. The angle selector mechanism includes an outer shaft that surrounds the inner drive shaft. The outer shaft is independently rotatable by the user relative to the inner drive shaft to angularly displace the distal working end of the surgical instrument. ^^^ Brief Description of the Drawing Figures The disclosure can be more completely understood in consideration of the following detailed description of various embodiments of the disclosure, in connection with the accompanying drawings, in which: Fig.1 is a side elevation view of an articulating surgical instrument in accordance ^^^ with a first embodiment and illustrating a first position^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^^^^^^^ ^^^ ^^^^^^^^^^^^^^^^^^^^ Fig.4 is a side elevation view thereof showing the articulating surgical instrument in a ^^^^^^^ ^^^^^^^^^ ^^^ Fig.5 is an enlarged view taken along the circle A of Fig.4^^ Fig.6 ^^^^^ ^^^ ^^^^^^^^^^^^^^^^^^^^ Fig.7 is a perspective view of an articulating surgical instrument in accordance with a ^^^^^^^^!^^^^!^^^^ ^^^^^"^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^#^

{02420/012010-WO0/03704276.1} ^ ^^^^^$^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^%^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^ ^^^ ^^^^^^^^^^^^^^^^^^^^ Fig.12 is a perspective view of an articulating surgical instrument in accordance with ^^ ^^^^^^^^^!^^^^!^^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^&^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^!^^^^^ Fig.15 is a side elevation view of an articulating surgical instrument in accordance ^^^^^^^^^^^^^^^!^^^^!^^^^ ^^^ Fig.16 is an ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^'^ ^^^^^^#^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^(^^^^^^^^^^'^ Fig.18 is a perspective view of a handle and angle selector mechanism with lock !^^^^^^^!^^^^^^^^^^ ^^^^^^^^^^^^^^^^^!^^^^^ ^^^^^^$^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^"^ ^^^ Fig.20 is a top plan partial view showing a drive shaft and handle parts along with a ^^^^^^^^^)^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^*^^^^^^^^^^%^ ^^^^^^^^^^^^^ ^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^!^^^^^^^!^ Fig.23 is a perspective view of the angle selector mechanism along with a pinion gear ^^^ ^^^^!^^^^ ^^^^^^&^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^+^^^^^^^^^^^^ Fig.25 is a close-up partial view a universal joint coupled to a distal housing with ^^^^^^^^^^^^^^^^^ Fig 26 is a close-up partial view of a locking mechanism for locking rotation of the ^^^ ^^^^^^^^^^^^^^^!^^^^^^^!^^ ^^^^^^#^^^^^^ ^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^"^^^^^^ ^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^$^^^^^^ ^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^!^^^^^^^!^^ ^^^^^^%^^^^^^ ^^^ ^^^^^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^ ^^^^ ^^^ Fig.31 is a side elevation view of an articulating surgical instrument in accordance ^^^^^^^^^^^^^^!^^^^!^^^^ Fig.32 is a side perspective view of an angle selector mechanism that is part of the ^^^^^^!^^^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^!^^^^^^^!^

{02420/012010-WO0/03704276.1} ^ ^^^^^^&^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^!^^^^^^^!^^ Fig.35A is a partial cross-sectional view of the locking mechanism in a locked ^^^^^^^^^ Fig.35B is a partial cross-sectional view of the locking mechanism in an unlocked ^^ ^^^^^^^^^^^^^ Fig.36 is a perspective view of a distal end of the instrument of Fig.31. While embodiments of the disclosure are amenable to various modifications and alternative forms, specifics thereof shown by way of example in the drawings will be ^^^ described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims. ^^^ Detailed Description of Certain Embodiments As previously mentioned, the present disclosure is directed to steerable surgical instruments. Each steerable surgical instrument provides a user, such as a surgeon, two intraoperative degrees of freedom, namely, (1) rotation about a primary axis that allows a ^^^,^^^^^^^^^^^^^^^^^^^!^^^^^^^^^^^^^^ ^^^^^^^^^^ ^^^^^!^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^ about a secondary axis that allows the user to drive a fastener (e.g., surgical screw) or tool bit or position a tool or surgical device at an angle up to 90 degrees in either direction from the primary axis. In many settings and applications, the ability to steer and angularly displace the distal fastener, tool bit, or device is required. In multiple embodiments disclosed herein, the surgical instrument has an inner drive ^^^ shaft that is rotatable by the user to effectuate a driving action of a distal working end of the surgical instrument and an outer shaft that is rotatable by the user to angularly displace the distal working end of the surgical instrument. In addition, a locking mechanism can be provided for the user to lock the position of the outer shaft relative to the inner drive shaft, thereby locking the distal working end at a desired angle relative to a primary (longitudinal) ^^^ axis of the surgical instrument. In one embodiment, the surgical instrument comprises a surgical screwdriver that allows surgeons (users) two intraoperative degrees of freedom and permits a surgical screw (fastener) or the like to be positioned at a desired angle relative to the primary axis and then driven into a surface, such as a bone, etc. As also mentioned herein, this type of surgical instrument has utility in spinal fusion procedures in which there is

{02420/012010-WO0/03704276.1} ^ a need to angle the fastener (surgical screw) to allow it to be driven into bone at the proper location and at the proper angle. In one embodiment, the surgical instrument has a distal housing that receives a fastener or tool bit or the like. This distal housing can be thought of as being a distal fastener ^^ (screw) housing or distal tool bit housing in the event that a tool bit is inserted into the distal housing instead of the fastener itself. The distal housing is configured to be easily interchanged with another distal housing that is of a different type. This allows different types of fasteners to be used. For example, one distal housing can be configured to receive and hold a first type of fastener, while another distal housing can be configured to receive and ^^^ hold a second type of fastener. Much like a socket wrench, when the user needs to switch fastener types or perform a different operation, the user simply removes the existing distal housing and replaces it with another. In a primary application, the distal housing holds a fastener, such as a surgical screw, and more particularly, the head of the fastener fits and is held in the distal housing. For ^^^ example, the distal housing can have a hexagonal shape that receives a hexagonal shaped fastener head. In the event that the distal housing receives a tool bit, the tool bit can be a driver bit that is used to drive the head of the fastener. One well known driver is a screwdriver with common screwdriver bits being square, hex, Phillips, torx/star, slotted, etc. Other tool bits ^^^ are drill bits. When the distal housing receives a tool bit, the tool bit is the structure that engages a fastener or the like. In another embodiment, the distal housing can receive and retain a surgical device, such as the ones described herein. First Embodiment (Figs.1-6) Now referring to Figs.1-6, a steerable surgical instrument 100 in accordance with a ^^^ first embodiment is shown. The steerable surgical instrument 100 is an elongated structure with a proximal end and a distal end. As with the other embodiments described herein, the steerable surgical instrument 100 is configured to (1) rotate ^^^^^^^^ ^^!^^^^^^^^^^^^^^^^^^ rotate about a secondary axis allowing a user, such as a surgeon, to drive a fastener or tool bit or position a tool at a prescribed angle (e.g., an angle up to 90 degrees) in either direction ^^^ from the primary axis. Since one preferred application for the surgical instrument 100, as well as the other surgical instruments disclosed herein, is driving of surgical fasteners, the discussion of the working distal end of the surgical instrument will primarily describe this application and describe that the distal housing holds a surgical fastener. However, as mentioned, the

{02420/012010-WO0/03704276.1} ^ working distal end can support other objects such as tool bits, surgical devices, etc., some of which are mentioned herein. The steerable surgical instrument 100 has a handle (shaft) 110 that is intended to be grasped by the user (surgeon). To allow the steerable surgical instrument 100 to rotate about ^^ the primary axis which allows for the user to provide a torque action to a fastener, there is a drive mechanism 120. The drive mechanism 120 is easily accessible by the user as the user grasps the steerable surgical instrument 100 along the handle 110 and can be freely rotated by the user. In one embodiment, the drive mechanism 120 is incorporated into the handle 110 in that the handle 110 functions as the drive mechanism. The drive mechanism 120 includes a ^^^ proximal actuator 122 which can be at and define the proximal end of the steerable surgical instrument 100 in that the proximal actuator 122 is located proximal to the handle 110. The proximal actuator 122 can be in the form of a contoured, ergonomic knob. The knob 122 defines the proximal end of an elongated drive shaft. As shown, the knob 122 can be generally circular in shape with modified areas for finger placement. For example, the knob ^^^ 122 can have a star shape or can be hexagonal in shape, etc. It will therefore be appreciated that the user can rotate the drive mechanism 120 by grasping and rotating either the knob 122 or the handle 110 since the two move in unison. The shaft of the handle 110 can also have an ergonomic shape, such as a hexagonal shape, etc. At a distal end of the drive shaft there is a first drive gear 130. The first drive gear ^^^ 130, as shown, can be a miter or bevel gear that is oriented perpendicular to the primary axis which is a longitudinal axis of the drive shaft. Rotation about a secondary axis allows the user to drive the fastener at a prescribed angle, such as an angle up to 90 degrees, in either direction from the primary axis. The steerable surgical instrument 100 also includes an angle selector mechanism 140 ^^^ that is configured to rotate about a secondary axis allowing the user to drive a tool bit or position a tool at the prescribed angle (e.g., an angle up to 90 degrees) in either direction from the primary axis. The angle selector mechanism 140 comprises an elongated outer body shaft 142. The outer body shaft 142 is a hollow structure that is open at its ends. The elongated drive shaft, which can be or be part of the handle 110, of the drive mechanism 120 passes ^^^ through the hollow interior of the outer body shaft 142 with the first drive gear 130 being distal to the outer body shaft 142. At a proximal end of the outer body shaft 142, there is an angle selector actuator 144 which can be in the form of a finger grip. The angle selector actuator 144 can be in the form of a pair of wings (protrusions) that protrude outwardly from the outer body shaft 142. As illustrated, there are two wings 144 located 180 degrees apart.

{02420/012010-WO0/03704276.1} ^ Twisting of the wings 144 results in rotation of the outer body shaft 142. The outer body shaft 142 is rotatable relative to the drive shaft of the drive mechanism and this rotation is translated into the angle selection (angle displacement) of the surgical fastener as described herein. ^^ At a distal end of the outer body shaft 142 there is a first angle selector gear 150 that is fixedly attached to the outer body shaft 142 and therefore, rotation of the outer body shaft 142 is directly translated into rotation of the first angle selector gear 150. The first angle selector gear 150 of the steerable surgical instrument 100 can be a miter or bevel gear that is oriented perpendicular to the primary axis which is a longitudinal axis of the outer body shaft ^^^ 142. As shown, the drive shaft passes through the center opening of the outer body shaft 142 and the first drive gear 130 is located adjacent and distal to the first angle selector gear 150. The first angle selector gear 150 has a greater diameter than the first drive gear 130 and thus, it surrounds the first drive gear 130 but is proximal thereto. The steerable surgical instrument 100 includes additional gears that are coupled to the ^^^ aforementioned gears to permit the steerable surgical instrument 100 to have the two degrees of freedom described herein. The steerable surgical instrument 100 can have a gear housing 151 that is coupled to the outer body shaft 142. As shown, the gear housing 151 can be attached to the distal end of the outer body shaft 142, with the gear housing 151 protruding outwardly from the outer body shaft 142. The gear housing 151 serves to support and carry ^^^ one or more gears that are part of one or more gear trains of the steerable surgical instrument 100. The gear housing 151 has a support leg or wall 152 that is oriented parallel to the longitudinal axis of the outer body shaft 142. A second angle selector gear in the form of a pinion gear 154 is rotatably mounted to the support leg 152 (e.g., the support leg 152 can ^^^ have a post on which the pinion gear 154 rotates). The pinion gear 154 is a miter or bevel gear that meshes with the first angle selector gear 150 such that rotation of the first angle selector gear 150 is translated into rotation of the pinion gear 154. The pinion gear 154 is formed at an angle relative to the first angle selector gear 150 and in particular, in the illustrated embodiment, the pinion gear 154 is formed at a 90° angle relative to the first angle ^^^ selector gear 150. The steerable surgical instrument 100 also includes a second drive gear 160 that is rotatably supported by the support leg 152. For example, the second drive gear 160 and the pinion gear 154 can be concentrically mounted to the support leg 152 (on the same post) with the second drive gear 160 being located inside the pinion gear 154 (and therefore, the second

{02420/012010-WO0/03704276.1} ^ drive gear 160 is oriented perpendicular to the first drive gear 130). In particular, while the pinion gear 154 meshes with the first angle selector gear 150, the second drive gear 160 meshes with the first drive gear 130. Rotation of the first drive gear 130 is thus translated into rotation of the second drive gear 160. The second drive gear 160 can be a miter or bevel ^^ gear. The steerable surgical instrument 100 also has a distal housing 170 that is operatively coupled to both the drive mechanism 120 and the angle selector mechanism 140 in that the drive mechanism 120 serves to rotate and drive (torque action) the distal housing 170 and the angle selector mechanism 140 serves to angularly displace the distal housing 170 from the ^^^ primary axis (i.e., the longitudinal axis of both the drive rod and the outer body shaft 142. This allows the driving action or tool positioning at an off-center position which is one which is angularly offset from the primary axis. The distal housing 170 is configured to receive and retain a tool bit or a surgical tool, etc. The distal housing 170 can include a hollow receptacle that receives and holds the ^^^ surgical fastener. The hollow receptable can have any number of different shapes, such as hexagonal, etc. The distal housing 170 is fixedly attached to the pinion gear 154 and therefore, the distal housing 170 moves when the pinion gear 154 rotates. For example, a tab or leg 157 is fixedly attached to the pinion gear 154 (along but radially outward from a set of teeth of the pinion gear 154). The leg 157 can be formed perpendicular to the inner face of ^^^ the pinion gear 154. The distal housing 170 has a third drive gear 180 that meshes with the second drive gear 160 and therefore, is operatively coupled to the first drive gear 130 in that rotation of the first drive gear 130 causes rotation of the third drive gear 180 due to the second drive gear 160 being meshed to (and between) both of these gears 130, 160. The distal housing 170 also includes a distal drive shaft 175 that is fixedly coupled to ^^^ and extends between the third drive gear 180 and the distal housing 170. Accordingly, when the third drive gear 180 rotates, this causes rotation of the distal drive shaft 175 and rotation of the distal housing 170 which is at the end of the distal drive shaft 175. The distal drive shaft 175 can pass through a hole in the leg 157 but is free to rotate relative to the leg 157. Figs.1-3 shows the steerable surgical instrument 100 in a first position in which the ^^^ distal housing 170 is coaxial with the primary axis. In other words, the distal housing 170 is not angularly displaced (offset) and is at a reference angle of 0. In this position, the angle selector mechanism 140 has not been actuated. The drive mechanism 120 can be actuated, by rotating the knob 122, to cause the distal housing 170 to be driven (rotated). For example, when a surgical fastener is contained in the distal housing 170, rotation of the drive shaft

{02420/012010-WO0/03704276.1} ^ results in rotation of the distal housing 170 and the surgical fastener much like a traditional screwdriver. When it is desired to steer and position the surgical fastener at a position offset from the 0 degree angle, the angle selector mechanism 140 is operated to cause the distal housing ^^ 170 to be angularly offset from the reference 0 degree angle position. To operate the angle selector mechanism 140, the elongated outer body shaft 142 is rotated relative to the handle 110. This rotation causes the first angle selector gear to rotate the pinion gear 154 and since the distal housing 170 is fixedly attached to the distal housing 170, the surgical fastener within the distal housing 170 is angularly offset relative to the primary axis. Figs.4-6 shows ^^^ this position in which the distal housing 170 has been angularly displaced from the 0 degree angle position. Once the distal housing 170 is moved to its desired angular position, the drive mechanism 120 is then operated to cause the driving action described herein. One of the advantages of the steerable surgical instrument 100 is that it has a compact handheld design in that the user can hold the handle 110 of the instrument and can easily ^^^ operate both the drive mechanism and the angle selector mechanism since that are positioned along the handle and both simply require a rotational movement of actuators associated with the two mechanisms. Second Embodiment Now referring to Figs.7-11 in which a second embodiment of a steerable surgical ^^^ instrument 200 is illustrated. It will be appreciated that the second embodiment shares a number of common parts and/or similar parts as the first embodiment and therefore, the discussion of the second embodiment focuses on the drive mechanism and the angle selector mechanism which have different makeups than in the first embodiment. The drive mechanism of the steerable surgical instrument 200 functions in the same ^^^ way in that the user rotates an elongated inner rod or inner shaft (generally shown at 201) to cause rotation of the drive mechanism (i.e., a driving action). For example, the drive mechanism includes an axial shaft gear 210 that is at a distal end of the inner shaft 201. When the inner shaft 201 is thus rotated, the axial shaft gear 210 rotates therewith in unison. The axial shaft gear 210 can have teeth or the like to allow it to mesh and engage another ^^^ gear as described below. Surrounding the axial shaft gear 210 is an angle selector gear 220 that can be in the form of a miter or bevel gear. Similar to the first embodiment, the angle selector gear 220 can be operated by rotation of an outer body shaft 230 that surrounds the drive shaft. The

{02420/012010-WO0/03704276.1} ^ angle selector gear 220 is located at the end of the outer body shaft 230 and is fixed thereto such that rotation of the outer body shaft 230 results in rotation of the angle selector gear 220. The angle selector mechanism 140 includes a gear housing 240 that is coupled to the outer body shaft 230. As shown, the gear housing 240 can be attached to the distal end of the ^^ outer body shaft 230, with the gear housing 240 protruding outwardly from the outer body shaft 230. The gear housing 240 serves to support and carry one or more gears that are part of the gear train of the steerable surgical instrument 100. More specifically, a shaft angle pinion 250 is rotatably carried by the gear housing 240. The shaft angle pinion 250 meshes with the angle selector gear 220 in that rotation of the outer body shaft 230 is translated into ^^^ rotation of the angle selector gear 220 and the shaft angle pinion 250. Accordingly, the shaft angle pinion 250 is positioned at an angle relative to the angle selector gear 220 (e.g., an angle of 90 degrees in the illustrated embodiment). The shaft angle pinion 250 carries a coupler 255 that is fixedly attached to the shaft angle pinion 250 and thus, rotates in unison with the shaft angle pinion 250. The coupler 255 can be in the form of a (closed) loop that is ^^^ fixedly attached to the shaft angle pinion 250. A distal drive shaft 260 is operatively coupled to the axial shaft gear 210 and therefore is part of the drive mechanism. In particular, the proximal end of the distal drive shaft 260 has a gear construction that is complementary to the axial shaft gear 210. As a result, rotation of the axial shaft gear 210 is translated into rotation of the distal drive shaft 260. The distal ^^^ drive shaft 260 passes though the closed loop and has at its distal end a distal housing 270. As in the first embodiment, the distal housing 270 is configured to hold a surgical fastener in an interchangeable manner. The second embodiment is thus similar to the first embodiment in that the drive mechanism is desired to rotate (apply torque to) the tool bit, while the angle selector ^^^ mechanism alters the angle of the tool bit or tool. The distal housing 270 can thus be angularly displaced a predetermined number of degrees from a primary axis that is parallel to and coaxial with the longitudinal axis of the inner drive shaft and the outer shaft body 230. In one embodiment, the distal housing 270 can move between a range of +90 degrees to -90 degrees relative to the primary axis. In the 0 degree position, the distal housing 270 is ^^^ coaxial with the inner drive shaft (and the outer shaft body 230). The steerable surgical instrument 200 can include a lock mechanism for locking the angle selector mechanism in a desired position. In other words, after the angle selector mechanism is used to position the distal housing 270 in the desired position or it is desired for the distal housing 270 to be in the reference 0 degree position, a lock mechanism can be used

{02420/012010-WO0/03704276.1} ^ to lock the angle selector mechanism and prevent the distal housing 270 and/or the angle selector mechanism from freely moving. Since the outer shaft body 230 serves as the basis to actuate the angle selector mechanism and thus, the lock mechanism can be a lock pin that is inserted into the outer shaft body 230 to prevent rotation thereof relative to the handle/drive ^^ mechanism. There can be one or more shaft locking pin ports 231 formed in the outer shaft body for receiving one or more locking pins. It will be appreciated that other types of locking mechanisms can be used to lock the angle selector mechanism in place. The lock mechanism does not interfere with the drive mechanism since once the distal housing 270 is set at the desired angle, the drive mechanism operates to cause rotation of the distal housing 270. The ^^^ lock mechanism can also include an angle locking pin port 233 that can receive a locking pin for locking the angle selector mechanism. Third Embodiment (Figs.12-14) Now referring to Figs.12-14 in which a third embodiment of a steerable surgical instrument 300 is illustrated. It will be appreciated that the third embodiment shares a ^^^ number of common parts and/or similar parts as the first and second embodiments and therefore, the discussion of the third embodiment focuses on the drive mechanism and the angle selector mechanism which have different makeups than in the first and second embodiments. The drive mechanism of the steerable surgical instrument 300 functions in the same ^^^ way in that the user rotates an elongated inner rod or inner shaft 310 to cause rotation of the drive mechanism (i.e., a driving action). In this embodiment, the inner shaft 310 comprises a flexible shaft that is freely able to bend as shown in the figures (i.e., which illustrate a bending at the distal end of the inner shaft 310). The inner shaft 310 articulates clockwise and counterclockwise and is attached to an inner drive actuator 320. The inner drive actuator ^^^ 320 comprises an elongated structure (elongated shaft) with a proximal end and an opposite distal end to which the inner shaft 310 is coupled. For example, the distal end of the inner drive actuator 320 can include a coupler, such as a hollow boss, that receives a proximal end of the inner shaft 310. In this way, the inner drive actuator 320 and the inner shaft 310 rotate in unison. The proximal end of the inner drive actuator 320 can include a knob 322 that ^^^ allows the user to easily rotate the inner shaft 310 in either direction. The rotation of the inner shaft 310 comprises a driving action as described herein. The angle selector mechanism includes an outer body shaft 330 that surrounds the inner drive actuator 320 and the inner shaft 310. The outer body shaft 330 includes a proximal end and a distal end. The proximal end can include a pair of wings 332 (fins or

{02420/012010-WO0/03704276.1} ^ flanges) that allow the user to easily grasp and manipulate the outer body shaft 330 such as imparting a rotation action thereto as part of an angle selector action. At the distal end of the outer body shaft 330 there is an angle selector gear 335 that is fixedly attached to the distal end of the outer body shaft 330 such that the outer body shaft ^^ 330 and the angle selector gear 335 rotate together. The illustrated outer body shaft 330 is hollow and has a cylindrical shape. A gear housing 340 that is coupled to the outer body shaft 330. As shown, the gear housing 340 can be attached to the distal end of the outer body shaft 330, with the gear housing 340 protruding outwardly from the outer body shaft 330. The gear housing 340 can ^^^ be generally L-shaped and serves to support and carry one or more gears that are part of the gear train of the steerable surgical instrument 300. More specifically, a shaft angle pinion 350 is rotatably carried by the gear housing 340. The shaft angle pinion 350 meshes with the angle selector gear 335 in that rotation of the outer body shaft 330 is translated into rotation of the angle selector gear 335 and the shaft angle pinion 350. Accordingly, the shaft angle ^^^ pinion 350 is positioned at an angle relative to the angle selector gear 335 (e.g., an angle of 90 degrees in the illustrated embodiment). The shaft angle pinion 350 carries a coupler 355 that is fixedly attached to the shaft angle pinion 350 and thus, rotates in unison with the shaft angle pinion 350. The coupler 355 can be in the form of a loop or an articulating guide shaft that is fixedly attached to the shaft angle pinion 350. As illustrated, the coupler 355 ^^^ comprises a disk-shaped structure with a center hole through which the flexible inner shaft 310 passes, thereby capturing the inner shaft 310. Since the coupler 355 is integral to the shaft angle pinion 350, the coupler 355 moves with the shaft angle pinion 350 and since the inner shaft 310 is flexible, the inner shaft 310 can freely bend to assume different angles. The inner shaft 310 thus passes though the center hole of the coupler 355 and has at ^^^ its distal end a distal housing 370. As in the first embodiment, the distal housing 370 is configured to hold a surgical fastener in an interchangeable manner as in the other embodiments. The third embodiment is thus similar to the first and second embodiments in that the drive mechanism is desired to rotate (apply torque to) the fastener, while the angle selector ^^^ mechanism alters the angle of the fastener. The distal housing 370 can thus be angularly displaced a predetermined number of degrees from a primary axis that is parallel to and coaxial with the longitudinal axis of the inner drive shaft and the outer shaft body 330. In one embodiment, the distal housing 370 can move between a range of 360 degrees relative to the primary axis. In the 0 degree position, the distal housing 370 is coaxial with the inner

{02420/012010-WO0/03704276.1} ^ drive shaft (and the outer shaft body 330). Unlike other embodiments in which the degree of angular motion is restricted, in this embodiment, the coupler 355 can rotate 360 degrees both clockwise and counterclockwise. The steerable surgical instrument 300 can include a lock mechanism for locking the ^^ angle selector mechanism in a desired position. It will be appreciated that many different types of lock mechanism can be used and function essentially to prevent free rotation of the outer shaft body 330. It will also be appreciated that the flexible inner shaft 310 can be replaced with an endoscope, catheter or cautery device (i.e., a surgical device or tool) providing a directed and ^^^ anglable approach. Fourth Embodiment (Figs.15-30) Now referring to Figs.15-30 in which a fourth embodiment of a steerable surgical instrument 400 is illustrated. It will be appreciated that the fourth embodiment shares a number of common parts and/or similar parts as the other embodiments and therefore, the ^^^ discussion of the fourth embodiment focuses on the drive mechanism and the angle selector mechanism which have different makeups than the other embodiments. The steerable surgical instrument 400 is an elongated structure with a proximal end and a distal end. As with the other embodiments described herein, the steerable surgical ^^^^^^!^^^^&%%^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^!^^^^^^^^^^^^^^^^^^^^^^^e about a ^^^ secondary axis allowing a surgeon to drive a surgical fastener and position it at a prescribed angle, such as an angle up to 90 degrees, in either direction from the primary axis. The steerable surgical instrument 400 has a handle 410 that is intended to be grasped by the user (surgeon). To allow the steerable surgical instrument 400 to rotate about the primary axis which allows for the user to provide a torque action to the tool bit or the like, ^^^ there is a drive mechanism 420. The drive mechanism 420 is easily accessible by the user as the user grasps the steerable surgical instrument 400 along the handle 410 and can be freely rotated by the user. As illustrated, the handle 410 comprises a first section 411 and a second section 412. The first section 411 represents a proximal handle portion, while the second section 412 represents a distal handle portion. As shown, the first section 411 can comprise a ^^^ fluted handle. The second section 412 can have a saddle shape defined by a concave center region that provides an ergonomic surface which can be grasped by the user. As described in more detail herein, the second section 412 can include a lock slot 415 formed therein. The lock slot 415 can be generally S-shaped in that it includes a first leg that faces the first section 411 and a third leg that faces away from the first section 411 and a

{02420/012010-WO0/03704276.1} ^ second leg that extends between the first and third legs. The first and third legs are parallel to one another, while the second leg is perpendicular to the first and third legs. As shown, when assembled, there is a slight space or gap between the first section 411 and the second section 412 of the handle 410. The first section 411 and the second section ^^ 412 can be coupled to one another to prevent any relative rotation between the first and second sections 411, 412. The drive mechanism 420 includes an elongated inner drive shaft 425. The inner drive shaft 425 is fixed to the handle 410 and extends in a longitudinal direction (the inner drive shaft is linear). More particularly, the inner drive shaft 425 can be fixedly attached to ^^^ the first section 411. For example, inner drive shaft 425 can extend into an inner bore formed in the first section 411 and is secured therein to the first section 411. For example, a fastener or bonding agent, such as an adhesive agent, or other techniques can be used to secure the inner drive shaft 425 to the first section 412. In the illustrated embodiment, a set screw can be used to secure the inner drive shaft 425 within the inner bore. It will be understood that ^^^ the second section 412 is also hollow and the inner drive shaft 425 also passes through the center of the second section 412. Since the inner drive shaft 425 is fixed to the handle 410, the inner drive shaft 425 rotates when the handle 410 rotates much like a standard screwdriver. The steerable surgical instrument 400 also includes an angle selector mechanism 440 ^^^ that is configured to rotate about a secondary axis allowing the user to drive a tool bit or position a tool at an angle up to a prescribed number of degrees, such as 90 degrees, in either direction from the primary axis. The angle selector mechanism 440 comprises an elongated outer body shaft 442. The outer body shaft 442 is a hollow structure that is open at its ends. The elongated inner drive shaft 425 of the drive mechanism 420 passes through the hollow ^^^ interior of the outer body shaft 442. At a proximal end of the outer body shaft 442, there is an angle selector actuator 444 which can be in the form of a knob that is manipulated by the user’s thumb and finger. The knob 444 can have a fluted or notched design. At the distal end of the outer body shaft 442, there is a first angle selector gear 450. The first angle selector gear 450 is fixed to the outer body shaft 442 and thus does not rotate ^^^ relative thereto. The first angle selector gear 450 can be a miter or bevel gear that is oriented perpendicular to the primary axis which is a longitudinal axis of the outer body shaft 442. The first angle selector gear 450 has a hole formed through the center to accommodate the drive mechanism.

{02420/012010-WO0/03704276.1} ^ Along the length of the outer body shaft 442, there are several other functional features. For example, the outer body shaft 442 can include a locating ring 441 that extends circumferentially about the outer body shaft 442 and radially outward therefrom. This locating ring 441 can serve to position the second section 412 along the outer body shaft 442. ^^ The second section 412 is thus disposed between the locating ring 441 and the knob 444 and in particular, the second section 412 can abut the locating ring 441. The locating ring 441 can be an integral feature of the outer body shaft 442. The outer body shaft 442 also includes a locking feature in the form of a set of teeth 449 that extend circumferentially about the outer body shaft 442 and thus are in the form of a ^^^ ring of teeth. The teeth 449 are located between the locating ring 441 and the knob 444. As such, the second section 412 of the handle 410 surrounds the teeth 449. When assembled, the knob 444 is disposed within the gap between the first and second sections 411, 412 of the handle 410 as shown. The fluted or otherwise contoured outer wall of the knob 444 is available for the user to grasp to initiate rotation of the outer ^^^ body shaft 442 relative to the handle 410. To initiate actuation of the angle selector mechanism 440, the user simply grasps the handle 410 and grasps the knob 444 and rotates the knob 444 in a clockwise or counterclockwise direction resulting in the outer body shaft 442 and the first angle selector gear 450 rotating in the same direction. The steerable surgical instrument 400 includes additional gears that are coupled to the ^^^ aforementioned gears to permit the steerable surgical instrument 400 to have the two degrees of freedom described herein. The steerable surgical instrument 400 can have a gear housing 460 that is coupled to the outer body shaft 442. As shown, the gear housing 460 can be attached to the distal end of the outer body shaft 442 (or can be an integral part thereof), with the gear housing 460 protruding outwardly from the outer body shaft 442. The gear housing ^^^ 460 serves to support and carry one or more gears that are part of the gear train of the steerable surgical instrument 400. The gear housing 460 has a support leg or wall 462 that is oriented parallel to the longitudinal axis of the outer body shaft 442. A second angle selector gear in the form of a pinion gear (loop gear) 464 is rotatably mounted to the support leg 462 (e.g., the support leg ^^^ 462 can have a post on which the pinion gear 464 rotates). The pinion gear 464 is a miter or bevel gear that meshes with the first angle selector gear 450 such that rotation of the first angle selector gear 450 is translated into rotation of the pinion gear 464. The pinion gear 464 is formed at an angle relative to the first angle selector gear 450 and in particular, in the

{02420/012010-WO0/03704276.1} ^ illustrated embodiment, the pinion gear 464 is formed at a 90° angle relative to the first angle selector gear 450. The shaft angle pinion gear 464 carries a coupler 455 that is fixedly attached to the shaft angle pinion 450 and thus, rotates in unison with the shaft angle pinion gear 464. The ^^ coupler 455 can be in the form of a loop that is fixedly attached to the shaft angle pinion gear 464. As shown, the coupler 455 can be located along and radially outward from a set of teeth of the shaft angle pinion gear 464. The coupler 455 is disposed perpendicular to the primary axis (the longitudinal axis of the instrument). Contact between the coupler 455 and the distal end of the outer shaft body 442 and/or the angle selector gear 450 defines the end of travel of ^^^ the coupler 455. As mentioned, in the illustrated embodiment, this range of motion is + or - 90°. The steerable surgical instrument 100 also has a distal housing 470 that is operatively coupled to both the drive mechanism 420 and the angle selector mechanism 440 in that the drive mechanism 420 serves to rotate and drive (torque action) the distal housing 470 and the ^^^ angle selector mechanism 440 serves to angularly displace the distal housing 470 from the primary axis (i.e., the longitudinal axis of both the drive rod and the outer body shaft 442. This allows the driving action or tool positioning at an off-center position which is one which is angularly offset from the primary axis. The distal housing 470 is configured to receive and retain the surgical fastener (or ^^^ alternatively, a tool bit or a surgical tool, etc.). The distal housing 470 can include a hollow receptacle that receives and holds the surgical fastener. The hollow receptable can have any number of different shapes, such as hexagonal, etc. The distal housing 470 is coupled to a pivotable joint 480 that is fixedly attached to the distal end of the inner drive shaft 425. The distal housing 470 can be interchangeably coupled to the pivotable joint 480 to allow the user ^^^ to swap out the distal housing 470 depending on the particular application to be undertaken. The proximal end of the pivotable joint 480 can include a hollow receptacle that receives the distal end of the inner drive shaft 425 such as by a friction fit or other mechanism fit or other fit type. Since the pivotable joint 480 is connected to the inner driven shaft 425, the pivotable joint 480 rotates when the inner driven shaft 425 rotates. In addition, the ^^^ pivotable joint incorporates a pivoting action that allows pivoting of the distal housing 470. The pivotable joint 480 can be a universal joint. As is known, a universal joint (also called a universal coupling or U-joint) is a joint or coupling connecting rigid shafts whose axes are inclined to each other. Universal joints are commonly used to transfer mechanical power between two shafts when their axes are at an angle to each other. In the illustrated

{02420/012010-WO0/03704276.1} ^ embodiment, the universal joint comprises a first part that has a first yolk 482 that one end and the opposite end is the hollow receptacle that receives the distal end of the inner drive shaft 425. The universal joint includes a second part that includes a second yolk 484 and a cross 485 is used to pivotally couple the second part to the first part and more particularly, ^^ couple the first yolk 482 to the second yolk 484. The distal housing 470 is thus at the distal end of the second part of the universal joint. -^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^)^^^^^^^^^^^^^^^! ^^^^^ ^^^^^^^^^)^^^^^&"%^^ however, other types of joints and coupling mechanisms can be used to achieve the disclosed ^^^ movements. The second part of the universal joint passes through the center opening of the coupler 455, which in the illustrated embodiment comprises a closed loop. The capture of the second part of the universal joint by the coupler 455 means that when the shaft angle pinion gear 464 is driven and rotates, the second part of the universal joint pivots. ^^^ In a first position, the distal housing 470 of the steerable surgical instrument 400 is coaxial with the primary axis. In other words, the distal housing 470 is not angularly displaced (offset) and is at a reference angle of 0. In this position, the angle selector mechanism 440 has not been actuated. In this case, the drive mechanism 420 can be actuated, by rotating the handle 410, to cause the distal housing 470 to be driven (rotated). ^^^ For example, rotation of the drive shaft results in rotation of the surgical fastener like a traditional screwdriver. When it is desired to steer and position the surgical fastener at a position offset from the 0 degree angle, the angle selector mechanism 440 is operated to cause the distal housing 470 to be angularly offset from the reference 0 degree angle position. To operate the angle selector mechanism 440, the elongated outer body shaft 442 is rotated ^^^ relative to the handle 410. The surgical instrument 400 also includes a lock mechanism 490 that allows the user to selectively lock the angle selector mechanism 440 and prevent any additional pivoting (movement) of the angle selector mechanism 440 and in particular, the distal housing 470 or surgical device located at the distal end of the surgical instrument. ^^^ The lock mechanism 490 include a lock actuator that is located along the handle 410 and can easily be manipulated by the user’s thumb or finger. The illustrated lock actuator comprises a locking mechanism toggle 494. The locking mechanism toggle 494 has an upper part 495 that can have an elongated shape and represents the part that is accessible to the user along the handle for contact. The user moves the locking mechanism toggle 494 by applying

{02420/012010-WO0/03704276.1} ^ a force to the upper part 495 as described herein. A top surface of the upper part 495 can be ribbed or include other surface modifying features to increase the ease of gripping and pushing the upper part 495. The locking mechanism 494 also includes a lower part 497 that can have an elongated ^^ shape and is connected to the upper part 495 with a post 496. The upper and lower parts 495, 497 are positioned parallel to one another with the post 496 being perpendicular to the upper and lower parts 495, 497. The shapes and sizes of the upper part 495 and the lower part 497 can be similar. Along a bottom surface of the lower part 497 there are teeth 498. The teeth 498 extend the length of the lower part 497 and are complementary to the teeth 449 in that the ^^^ teeth 497 can mesh with the teeth 449. As described herein, when the teeth 497 mesh with the teeth 449, it acts as a brake or lock mechanism that prevents further rotation of the outer body shaft 440. The locking mechanism toggle 494 is received within the lock slot 415 and more particularly, the upper part 495 is positioned external to the handle 410 (i.e., along an outer ^^^ surface of the second section 412) and the lower part 497 is located underneath between the handle 410 and the outer body shaft 442. The post 496 passes through the lock slot 415. As mentioned, the legs of the lock slot 415 define the path of movement of the locking mechanism toggle 494 and further define the unlocked position and the locked position of the locking mechanism toggle 494. As illustrated, in the unlocked position, the locking ^^^ mechanism toggle 494 (including the post 496) is within the first leg of the lock slot 415 and is spaced from the teeth 449 formed on the outer body shaft 442. This represents the unlocked position since the teeth 497 are not meshed with the teeth 449. To move to the locking mechanism toggle 494 to the locked position, the locking mechanism toggle 494 is pushed forward (toward the distal end of the surgical instrument) ^^^ within the first leg and then is moved laterally into the second leg of the lock slot 415 before then entering and moving forward within the third leg. This action is similar to driving a manual transmission and moving the gear shifter. When the locking mechanism toggle 494 moves to the locked position, the teeth 497 mesh with the teeth 449. Since the locking mechanism toggle 494 is fixed to the handle 410, the meshing of the teeth 497, 449 prevents ^^^ the outer shaft tube 442 from rotating. Since rotation of the outer shaft tube 442 is the actuating means for the angle selector mechanism 440, the angle selector mechanism 440 is locked when the lock mechanism toggle 494 is in the locked position. By laterally offsetting the first and third legs, the locking mechanism toggle 494 cannot inadvertently move from the locked position to the unlocked position.

{02420/012010-WO0/03704276.1} ^ As with all of the embodiments, the distal housing 470 can support any number of different types of surgical fasteners, or tools bits, such as the drive bits mentioned herein, or surgical devices. Fifth Embodiment (Figs.31-36) ^^ Now referring to Figs.31-36 in which a fifth embodiment of a steerable surgical instrument 500 is illustrated. It will be appreciated that the fifth embodiment shares a number of common parts and/or similar parts as the other embodiments and therefore, the discussion of the fifth embodiment focuses on the drive mechanism, the angle selector mechanism, and the lock mechanism which have different makeups than the other embodiments. ^^^ As in the other embodiment, the instrument 500 is an elongated structure that has a handle 510 at a proximal end and working components at an opposite distal end. The handle 510 can be rotated by a user. The instrument 500 includes a drive mechanism that includes the elongated inner drive shaft 425. The inner drive shaft 425 is fixed to the handle 510 and extends in a ^^^ longitudinal direction (the inner drive shaft is linear). More particularly, the inner drive shaft 425 can be fixedly attached to the body of the handle 510. For example, inner drive shaft 425 can extend into an inner bore formed in the body of the handle 510 and is secured therein. For example, a fastener or bonding agent, such as an adhesive agent, or other techniques can be used to secure the inner drive shaft 425 to the body of the handle 510. Since the inner ^^^ drive shaft 425 is fixed to the handle 510, the inner drive shaft 425 rotates when the handle 510 rotates much like a standard screwdriver. The instrument 500 also includes an outer body shaft 501 that extends longitudinally. As shown in the figures and as described herein in more detail, the ends of the outer body shaft 501 can be outwardly tapered such that the ends are enlarged (greater diameter) than the ^^^ center shaft section. The outer body shaft 501 is hollow and includes a center bore through which other parts pass. The steerable surgical instrument 500 also includes an angle selector mechanism 540 that is configured to rotate about a secondary axis allowing the user to drive a tool bit or position a tool at an angle up to a prescribed number of degrees, such as 90 degrees, in either ^^^ direction from the primary axis. The angle selector mechanism 540 comprises an elongated inner body shaft 542. The inner body shaft 542 is a hollow structure that is open at its ends. The elongated inner drive shaft 425 of the drive mechanism passes through the hollow interior of the inner body shaft 542. At a proximal end of the inner body shaft 542, there is an angle selector actuator 544 which can be in the form of a knob that is manipulated by the

{02420/012010-WO0/03704276.1} ^ user’s thumb and finger. The knob 544 can have a fluted or notched design and has a diameter greater than a diameter of the inner body shaft 542. At the distal end of the inner body shaft 542, there is a first angle selector gear 550. The first angle selector gear 550 is fixed to the inner body shaft 542 and thus does not rotate ^^ relative thereto. The first angle selector gear 550 can be a miter or bevel gear that is oriented perpendicular to the primary axis which is a longitudinal axis of the inner body shaft 542. The first angle selector gear 550 has a hole formed through the center to accommodate the drive mechanism. The angle selector actuator 544 and the inner body shaft 542 is hollow to permit the ^^^ inner drive shaft 425 to pass centrally therethrough. As shown in Fig.32, an inner planar face of the angle selector actuator 544 includes a plurality of posts 545. The posts 545 extend in a longitudinal direction toward the first angle selector gear 550 at the distal end of the inner body shaft 542 (Figs.32-33). Each post 545 is oriented perpendicular to the inner face of the angle selector actuator 544. The posts 545 are ^^^ formed circumferentially about the inner face. As discussed herein, each post 545 is intended to support a biasing element, in the form of a coil spring 543 (Fig.35A). The coil spring 543 can be disposed about the post 545. In the illustrated embodiment, there are four posts 545 and four coil springs 543. The instrument 500 also includes a locking feature (locking mechanism) that, similar ^^^ to the other embodiments, is configured to lock the angle selector mechanism 450 in a given (rotated) position. The locking mechanism includes a toggle 600 that is disposed about the angle selector mechanism 450. The toggle 600 can be ring-shaped with a hollow center hole. The toggle 600 has an outer face that includes recesses that receive ends of the coil springs 543, thereby coupling and biasing the toggle 600 to the angle selector actuator 544. Figs.35A ^^^ shows an at rest position in which the coil spring 543 are in extended states, whereby the toggle 600 is pushed forward from the angle selector actuator 544. The inner face of the toggle 600 (Figs.33 and 35A-B) includes a plurality of locking nubs 610 (protrusions) that are formed along an inner face of the toggle 600 and extend in a longitudinal direction toward the first angle selector gear 550 at the distal end of the inner body shaft 542 (Figs.32-33). ^^^ Each locking nub 610 is oriented perpendicular to the inner face of the toggle 600. The locking nubs 610 are formed circumferentially about the inner face. As shown in Fig.34, the proximal end 503 of the outer body shaft 501 includes the second part of the locking mechanism that is complementary to the plurality of locking nubs 600. More specifically, the second part of the locking mechanism comprises a plurality of

{02420/012010-WO0/03704276.1} ^ holes 610 that can be considered to be locking nub mating holes. The plurality of holes 610 are formed in a circumferential pattern in the planar proximal end 503 and are formed that when the instrument 500 is assembled, the locking nubs 600 can be positioned axially in registration with corresponding holes 610. The number of holes 610 exceeds the number of ^^ locking nubs 600. In the illustrated embodiment, there are four locking nubs 600 that are oriented 90 degrees apart from one another and there are twenty-eight holes 610. As described below, when the locking nubs 600 are received within four corresponding holes 610, the angle selector mechanism 540 is locked in place relative to the outer body shaft 501. Fig.35A shows the locked position of the locking mechanism (angle ^^^ fixation). When the locking mechanism is allowed to sit in its neutral position of Fig.35A, the locking nubs 600 mate with the housing (outer body shaft 501), allow no rotation of the angle selector mechanism. Fig.35B shows the unlocked position which is an angle articulation/selection position. When the locking mechanism (e.g., the toggle 600) is pulled down (back), the locking nubs 600 disengage from the holes 610 in the housing (outer body ^^^ shaft 501), allowing rotation of the angle selector mechanism. When the toggle 600 is pulled in the proximal direction, the coil springs 543 compress as shown. Once the user releases the pulled back toggle 600, stored energy in the coil springs 543 is released and the toggle 600 moves distally, the locking nubs 600 are free to enter corresponding holes 610. Fig.36 shows a screwdriver unit (housing) 700 that is coupled to the pivotable joint ^^^ 480 that includes the first yolk 482 and the second yolk 484. At the distal end of the outer body shaft 501 there is a gear housing 630, that is similar to the gear housing 460, and has a center bore through which the other parts pass. The gear housing 630 serves to support and carry one or more gears that are part of the gear train of the steerable surgical instrument 500. The gear housing 630 has a support leg or wall 632 that is oriented parallel to the ^^^ longitudinal axis of the outer body shaft 501. The pinion gear (loop gear) 464 is rotatably mounted to the support leg 632 (e.g., the support leg 632 can have a post on which the pinion gear 464 rotates). The pinion gear 464 is a miter or bevel gear that meshes with the first angle selector gear 550 such that rotation of the first angle selector gear 550 is translated into rotation of the pinion gear 464. The pinion gear 464 is formed at an angle relative to the first ^^^ angle selector gear 550 and in particular, in the illustrated embodiment, the pinion gear 464 is formed at a 90° angle relative to the first angle selector gear 550. As in the other embodiments, the pinion gear 464 includes a coupler 640 that is integral thereto and moves in unison as the pinion gear 464 rotates. The coupler 640 includes a through hole through

{02420/012010-WO0/03704276.1} ^ which the pivotable joint 480 passes and thus, when the coupler 640 pivots, the pivotable joint 480 likewise is driven and pivots. Operation of the instrument 500 is very similar to the operation of instrument 400 with the exception of the different lock mechanism. More specifically, the handle 510 ^^ permits rotation of the drill bit contained in the so as to apply a torque action to the drill bit contained in the screwdriver unit (housing) 700 and the angle selector mechanism 540 permits for the angle of the drill bit relative to the longitudinal axis of the instrument to be changed. In the embodiments disclosed herein, the angle of interaction between the fixed angle ^^^ selector gear and tail pinion can be reported with precision by a rotary encoder connected to a neuronavigation unit via Bluetooth or some other wireless connection. Therefore, it extends neuronavigation compatibility to non-straight angle screwdrivers. Moreover, each prototype can be linked to a motor controlled by the surgeon to allow automatic, instead of manual driving of the screw into bone. This controller, encoder and neuronavigational compatibility ^^^ allows the screwdriver to become an electronic screwdriver and compatible with robotic systems. This device is capable of being used in surgical approaches beyond the spine that require the delivery of screw into bone. This technology can be expanded to taps and probes to support the full screw driving process. One key feature of the present technology is that it provides surgeons with two stable degrees of freedom in their instrumentation and this ^^^ technology can be expanded to other surgical tools including but not limited to scissors, drains and taps. The instruments disclosed herein can have additional applications beyond drive tools (e.g., drive tool bits, etc.). For example, the technology disclosed that is directed to providing additional degrees of freedom and improved feedback to taps, scissors, cauterizers, catheters, ^^^ etc. As mentioned, the surgical instruments described and illustrated herein have widespread applicability and can be used for many different surgical applications. In one application, the surgical instrument comprises an anglable driver for a spinal fusion procedure. ^^^ In one application, the surgical instrument comprises an anglable driver for an anterior lumbar interbody fusion procedure. In one application, the surgical instrument comprises an anglable driver for an occipital-cervical fusion procedure.

{02420/012010-WO0/03704276.1} ^ It will also be appreciated that the dimensions of the components of the surgical instruments disclosed herein can be selected in view of the particular intended application. For example, the surgical instrument can be formed to have different lengths. In addition, the diameters of the inner and outer shafts can be varied. The distal fastener housing is sized in ^^ view of the shape and dimensions of the surgical fastener that is to be inserted and held therein. It will also be appreciated that the surgical instruments can be formed of different materials, such as metal or plastics or a combination thereof. For example, the inner drive shaft and the outer shaft body and the various gears can be formed of metal, such as a ^^^ titanium alloy. Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce ^^^ numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions. Persons of ordinary skill in the relevant arts will recognize that the subject matter ^^^ hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. ^^^^^^^^^^^.^^^^^^!^^^^!^^^^^^^^^^^^^!^^^^^^^^^^^^^^^^^^^^!^^^^^^^^^^^^^^^^^^^^^^ rather, the various embodiments can comprise a combination of different individual features selected ^^^ from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted. Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the ^^^ dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended. Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by

{02420/012010-WO0/03704276.1} ^ reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein. ^^ For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. § 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim. ^^^

{02420/012010-WO0/03704276.1}

Claims

^ What is claimed is: 1. A steerable surgical instrument comprising: a drive mechanism for driving a working distal end of the surgical instrument, the ^^ drive mechanism including an inner drive shaft that is rotatable by a user resulting in rotation of the working distal end^^^^^ an angle selector mechanism that is configured to angularly displace the working distal end of the surgical instrument relative to a primary axis that comprises a longitudinal axis of the surgical instrument, the angle selector mechanism including an outer shaft that ^^^ surrounds the inner drive shaft, the outer shaft being independently rotatable by the user relative to the inner drive shaft to angularly displace the distal working end of the surgical instrument. 2. The steerable surgical instrument of claim 1, wherein the inner drive shaft is fixedly attached to a fastener housing that comprises the working distal end of the ^^^ surgical instrument. 3. The steerable surgical instrument of claim 1, wherein the inner drive shaft is coupled, by means of a gear arrangement, to a fastener housing that comprises the working distal end of the surgical instrument. 4. The steerable surgical instrument of claim 1, wherein the drive mechanism ^^^ includes a first gear train for rotatably driving the working distal end that comprises a fastener housing and the angle selector mechanism includes a second gear train. 5. The steerable surgical instrument of claim 4, wherein a distal end of the inner drive shaft includes a first drive gear that is part of the first gear train and a distal ^^^ end of the outer shaft includes a first angle selector gear. 6. The steerable surgical instrument of claim 5, further including a gear housing unit that is fixedly attached to the outer shaft, the gear housing including a second drive gear and a second angle selector gear that has a guide member fixedly attached thereto, the guide member supporting a third drive gear that is attached to ^^^ the fastener housing. 7. The steerable surgical instrument of claim 1, wherein the first drive gear and the first angle selector gear are concentric with one another and the second drive gear and the second angle selector gear are concentric with one another.

{02420/012010-WO0/03704276.1} ^ 8. The steerable surgical instrument of claim 6, wherein the guide member comprises a closed loop that is integral and fixed to the second angle selector. 9. The steerable surgical instrument of claim 5, wherein the first gear train comprises beveled gears and the second gear train comprises beveled gears. ^^ 10. The steerable surgical instrument of claim 1, wherein the inner drive shaft comprises a flexible shaft. 11. The steerable surgical instrument of claim 1, wherein the inner driven shaft comprises a flexible shaft and a distal end of the outer shaft includes a first angle selector gear and the surgical instrument further includes a gear housing unit that ^^^ is fixedly attached to the outer shaft, the gear housing including a second angle selector gear that has a guide member fixedly attached thereto, the guide member having an opening through which the flexible shaft passes. 12. The steerable surgical instrument of claim 11, wherein the first and second angle selector gears comprise bevel gears. ^^^ 13. The steerable surgical instrument of claim 1, wherein the drive mechanism includes a handle of the surgical instrument. 14. The steerable surgical instrument of claim 1, further including a lock mechanism configured to lock the angle selector mechanism in a prescribed position. 15. The steerable surgical instrument of claim 1, wherein the working distal end ^^^ comprises an interchangeable fastener housing that is configured to receive and hold a surgical fastener. 16. The steerable surgical instrument of claim 1, wherein the outer shaft includes a pair of wings that extend radially outward from the outer shaft to facilitate rotation of the outer shaft. ^^^ 17. The steerable surgical instrument of claim 1, wherein the working distal end comprises a fastener housing that that has a contoured receptacle that receives a complementary shaped head of a surgical screw. 18. A surgical instrument comprising: ^^^^^^^^^ ^^^ ^^^^^^^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^ a hollow shaft body having an inner lumen through which the shaft passes, the hollow ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

{02420/012010-WO0/03704276.1} ^ a second gear coupled to the hollow shaft body and meshed with the first gear such ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ a guide port fixedly coupled to the second gear such that the guide port moves with ^^^^^^^^^^^^^^^^^^^^ ^^ a pivotable joint including a first part that is fixedly coupled to the shaft and a second part that pivots relative to the first part, the second part passing through the guide port and being configured to receive a tool bit at a distal end thereof, whereby rotation of the first and second gears and movement of the guide port changes an angle of the second part relative to the hollow shaft body. ^^^ 19. The surgical instrument of claim 18, wherein the shaft comprises a rod that is centrally located within the handle and passes centrally through the inner lumen of the hollow shaft body. 20. The surgical instrument of claim 18, wherein each of the first gear and the second gear comprises a miter gear. ^^^ 21. The surgical instrument of claim 18, wherein the first gear has a hole through which the first part of the pivotable joint passes. 22. The surgical instrument of claim 18, wherein the second gear is oriented perpendicular to the first gear. 23. The surgical instrument of claim 18, wherein the shaft is non-rotationally ^^^ connected to the handle. 24. The surgical instrument of claim 18, wherein the first part is hollow and a distal end of the shaft is received within the hollow first part to couple the shaft to the pivotable joint. 25. The surgical instrument of claim 18, wherein the pivotable joint comprises a U- ^^^ joint, with the first part not being movable relative to the shaft, while the second part is configured to pivot relative to the first part. 26. The surgical instrument of claim 25, wherein the second part has a U-shaped proximal end that attaches to the first part at a pivot axis and has an interchangeable head housing that is configured to receive the tool bit. ^^^ 27. The surgical instrument of claim 18, wherein the guide port comprises a loop structure that is integrally attached to the second gear, with the second part of the pivotable joint passing through the loop structure such that rotation of the second gear results in movement of the loop structure and pivoting of the second part relative to the first part.

{02420/012010-WO0/03704276.1} ^ 28. The surgical instrument of claim 27, wherein the loop structure protrudes outwardly from the second gear and is oriented perpendicular to a longitudinal axis of the hollow shaft body. 29. The surgical instrument of claim 18, wherein the pivotable joint is configured to ^^ pivot across 180 degrees. 30. The surgical instrument of claim 29, wherein the pivotable joint is configured to pivot up to – 90 degrees relative to a longitudinal axis of the shaft and up to + 90 degrees relative to the longitudinal axis of the shaft. 31. The surgical instrument of claim 27, wherein the loop structure is located along ^^^ and protrudes outwardly from a set of teeth of the second gear. 32. The surgical instrument of claim 18, wherein the second gear is coupled to the hollow shaft body by a gear mount. 33. The surgical instrument of claim 32, wherein the gear mount is disposed around the hollow shaft body and includes a post about which the second gear rotates, the ^^^ post being oriented perpendicular to a longitudinal axis of the shaft. 34. The surgical instrument of claim 18, wherein the hollow shaft body includes an integral grip member at a proximal end thereof, the grip member being accessible along the handle to allow rotation by a user resulting in rotation of the hollow shaft body and the first gear. ^^^ 35. The surgical instrument of claim 34, wherein the grip member comprises a notched wheel. 36. The surgical instrument of claim 34, wherein the grip member partitions the handle into a proximal end portion and a distal end portion with the grip member having 360 degrees of exposure and accessibility. ^^^ 37. The surgical instrument of claim 18, further comprising a lock mechanism configured to lock the hollow shaft body and prevent rotation of the hollow shaft body relative to the handle. 38. The surgical instrument of claim 37, wherein the lock mechanism comprises a surface modified section of the hollow shaft body and a movable locking toggle ^^^ that is disposed within the handle and moves between a locked position and an unlocked position, wherein in the locked position, the locking toggle engages the surface modified section of the hollow shaft body and in the unlocked position, the locking toggle is laterally offset from the surface modified section of the hollow shaft body.

{02420/012010-WO0/03704276.1} ^ 39. The surgical instrument of claim 38, wherein the surface modified surface comprises teeth that extend 360 degrees around an outer surface of the hollow shaft body and the locking toggle has complementary teeth that engage the teeth on the outer surface of the hollow shaft body. ^^ 40. A surgical instrument comprising: ^^^^^^^^^ ^^^^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ a pivotable joint including a first part that is fixedly coupled to and not rotatable relative to the handle and a second part that pivots relative to the first part and the^^^ handle, the second part being configured to receive a tool bit at a distal end the^^^^^^ and a loop gear meshed with the first gear, the loop gear capturing the second part such that rotation of the first gear is translated into rotation of the second gear and pivoting of the second part so as to change an angle of the second part relative to the handle. ^^^ 41. A surgical instrument comprising: ^^^^^^^^^ ^^^^^^^^!^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ a pivotable joint including a first part that is fixedly coupled to and not rotatable relative to the handle and a second part that pivots relative to the first part and the^^^ handle, the second part being configured to receive a tool bit at a distal end the^^^^^^ and a second miter gear meshed with the first miter gear and rotatable about a second axis that is perpendicular to the first axis, the second miter gear having an integral loop that surrounds the second part such that rotation of the first gear is translated into ^^^ rotation of the second gear and pivoting of the second part so as to change an angle of ^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^ wherein the integral loop lies in a plane that is parallel to the second axis. 42. A surgical instrument comprising: a ^^^^^^^ ^^^ ^^^^^^^^!^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ a pivotable joint including a first part that is fixedly coupled to and not rotatable relative to the handle and a second part that pivots relative to the first part and the handle, the second part being configured to receive a tool bit at a distal end the^^^^^^

{02420/012010-WO0/03704276.1} ^ a second miter gear meshed with the first miter gear and rotatable about a second axis that is perpendicular to the first axis, the second miter gear having an integral loop that surrounds the second part such that rotation of the first gear is translated into rotation of the second gear and pivoting of the second part so as to change an angle of ^^ ^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ a lock mechanism to lock the pivotable joint at a predetermined angle relative to the first axis. 43. The surgical instrument of claim 42, further including a hollow shaft body that is rotatable relative to the handle with the first miter gear being disposed at a distal ^^^ end of the hollow shaft body and wherein the lock mechanism comprises a surface modified section of the hollow shaft body and a movable locking toggle that is disposed within the handle and moves between a locked position and an unlocked position, wherein in the locked position, the locking toggle engages the surface modified section of the hollow shaft body and in the unlocked position, the ^^^ locking toggle is laterally offset from the surface modified section of the hollow shaft body. 44. The surgical instrument of claim 42, further including: a hollow outer shaft body having a proximal end face^ an angle selector mechanism that includes an inner shaft body with the first miter ^^^ gear being disposed at a distal end thereof and an angle selector actuator disposed ^^^^^ ^^^^!^^^^^^^^^^^^^^^^ wherein the lock mechanism comprises a toggle that is spring biased relative to the angle selector actuator and includes a plurality of locking nubs that protrude outwardly from a distal end face, the proximal end face having a plurality of ^^^ circumferentially arranged holes that are configured to receive the plurality of locking nubs for locking the angle selector mechanism. 45. The surgical instrument of claim 44, further including: a drive shaft fixedly coupled to the handle and disposed within the outer shaft body, the drive shaft being coupled to the pivotable joint such that rotation of the handle is ^^^ translated into rotation of the pivotable joint. 46. The surgical instrument of claim 45, wherein the angle selector actuator comprise a rotatable knob that surrounds a distal end of the handle and the toggle is disposed between the angle selector actuator and the proximal end face, the toggle being movable between: (1) an unlocked position in which one or more springs

{02420/012010-WO0/03704276.1} ^ are compressed and store energy and the plurality of locking nubs are disengaged from the plurality of circumferentially arranged holes, and (2) a locked position in which the one or more springs are in at rest extended positions and the plurality of locking nubs are engaged with the plurality of circumferentially arranged holes. ^^ 47. The surgical instrument of claim 45, wherein the drive shaft rotate independently from the angle selector mechanism. 48. A surgical instrument comprising: ^^^^^^^^^ ^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^^^^^^^^^^^^^^ ^^^ a hollow shaft body that surrounds the drive shaft, the hollow shaft body being ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ a distal tool coupler that is fixedly coupled to the drive shaft such that rotation of the drive shaft is translated into rotation of the distal tool coupler and is operatively coupled to the hollow shaft body such that rotation of the hollow shaft body is ^^^ translated into angular displacement of the distal tool coupler, the distal tool coupler being configured to be receive a tool that is capable of being rotatably driven due to action of the drive shaft and being angularly displaced due to rotation of the hollow shaft body. ^^^ ^^^ ^^^

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