Surgical implant instruments

Abstract

The surgical instrument for interfacing with the implant can include an inserter configured to dock with one side of the implant. The inserter can include a control shaft configured to lock or unlock the inserter's connection with the implant. Actuation of the control shaft can be performed by a knob that can control movement of the control shaft. The inserter can facilitate positioning of the implant relative to the surgical site and can allow for counter torque when applying torque to tighten a set screw or the like. Additional instruments can also be used to manipulate the implant. For example, an auxiliary instrument, such as a reducer instrument, can be coupled to the inserter to facilitate rod reduction or the like. Alternatively or additionally, a holder instrument can be used, having a threaded distal engagement feature for coupling to the implant and facilitating its positioning.

Description

[Technical Field]

[0001] The present disclosure relates generally to surgical instruments and related methods of use, and more particularly to instruments for interfacing with implants, such as surgical connectors that connect multiple fixation rods or other elements, to facilitate various surgical procedures, including spinal surgery. [Background technology]

[0002] Fixation systems can be used in orthopedic surgery or neurosurgery to maintain a desired spatial relationship between multiple bones or bone fragments. For example, various spinal conditions, such as fractures, deformities, and degenerative diseases, can be treated by attaching a spinal fixation system to one or more vertebrae. Such systems can include spinal fixation elements, such as rods, connected to the vertebrae by one or more bone anchors, such as screws or hooks. Fixation systems can also include various other implants, such as connectors for attaching multiple rods to each other. Once installed, the fixation system can hold the vertebrae in a desired position until healing or spinal fusion can occur, or for some other period of time.

[0003] Conventional instruments and systems have several drawbacks for manipulating and handling surgical implants, including surgical connectors, at a surgical site, particularly in the case of minimally invasive procedures or procedures involving areas with narrow anatomical constraints, such as the lumbar or thoracic spine. For example, while many handling instruments have been developed for certain spinal fixation elements, such as implantable pedicle screws or rods, relatively few instruments have been developed for handling or joining spinal fixation connectors that bridge between multiple spinal fixation rods or other elements. Thus, surgeons using connector implants are often left to make do with instruments that were not intended for use when needed.

[0004] Furthermore, existing implant handling tools, such as rod holders and clamps, as well as the fingers of a user's hand, may not provide sufficient clamping force to resist the multidirectional forces exerted on the implant as it is manipulated within the surgical site, making it difficult to position the implant. Furthermore, insertion instruments can be quite bulky, limiting the extent to which or how the implant can be manipulated, impeding the insertion of rods or other components into the implant, or causing other challenges. Moreover, such insertion instruments can lack several important capabilities, including the ability to provide access to the implant and / or other components after implantation, the ability to provide counter torque during assembly and final locking of the spinal fixation system, the ability to couple with other instruments for various additional operations, etc. Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, there is a need for an improved surgical connector instrument that allows for improved insertion and handling of a surgical connector at a surgical site. [Means for solving the problem]

[0006] Disclosed herein are surgical instruments, systems, and related methods of use that provide improved insertion and handling of implants, such as surgical connectors, bone screws, or anchors, during surgical procedures. Various such instruments are disclosed herein, and in one embodiment, an inserter instrument can be provided for docking with one side of an implant, such as a connector, bone screw, or the like, to facilitate manipulation and insertion of the implant into a surgical site. The inserter instrument can use a knob or locking handle to activate a locking mechanism to switch the inserter instrument between an unlocked configuration and a locked configuration with the connector. In some embodiments, the inserter instrument can provide counter torque during spinal rod reduction, set screw insertion, and various additional surgical procedures without uncoupling the inserter instrument from the implant. The inserter instrument can also include one or more features to facilitate coupling with ancillary instruments. For example, a reducer instrument can be attached to the inserter instrument to facilitate reduction of a rod or other fixation element onto the implant. The reducer instrument can include a reducer shaft disposed within the housing such that rotation of the reducer shaft threads a proximal end of the reducer shaft through the housing and translates a distal portion into contact with the rod disposed within the implant until the spinal rod is properly reduced or seated relative to the implant. In some embodiments, a holder instrument can be coupled to the implant to facilitate insertion and handling of the implant at the surgical site. The holder instrument can include one or more thread forms, including male and female threads, to provide multiple options for coupling to the surgical implant.

[0007] In one aspect, a surgical instrument is disclosed that can include a proximal handle and a distal inserter portion having an elongated body that can define a hollow interior. The distal inserter portion can have an opening for receiving a portion of the proximal handle therein. The instrument can further include a locking portion configured to engage one side of an implant and a control shaft that can be received in the hollow interior. The control shaft can be configured to translate distally to engage the implant engaged by the locking portion. The instrument can also include a knob configured to engage a proximal end of the control shaft to translate the control shaft relative to the distal inserter portion and transition the locking portion from an unlocked configuration to a locked configuration to secure the locking portion to the implant.

[0008] Any of a variety of alternative or additional features can be included and are considered within the scope of the present disclosure. For example, in some embodiments, the locking portion can further include a retractable clasp that can slide along the surface of the implant and engage a groove formed within the implant during distal translation of the control shaft.

[0009] In certain embodiments, transitioning to the locked configuration can include pulling the retractable clasp upward and inward to press a proximally facing bearing surface of the clasp against a distally facing bearing surface of the implant.

[0010] In some embodiments, the locking portion can also include one or more insertion tabs and stop beams, where the insertion tabs can engage and lock onto a surface of the implant and the stop beams can be configured to abut the implant to prevent further translation of the control shaft.

[0011] In certain embodiments, the distal inserter portion can include one or more attachment features extending therefrom, which can be configured to be received within an auxiliary instrument for coupling to the auxiliary instrument. The one or more attachment features, in some embodiments, can include one or more pins extending from the body of the distal inserter portion.

[0012] In certain embodiments, the assistive instrument may be a reducer instrument capable of engaging one or more attachment features, and the reducer instrument may have a reducer shaft received within a housing to reduce the spinal rod into the implant. In some embodiments, the housing of the reducer instrument may include one or more arms extending from the housing, and the arms may have one or more tracks for receiving the one or more attachment features therein. In certain embodiments, the reducer instrument may include a retention lever coupled to the housing to facilitate locking the reducer instrument to the one or more attachment features. In some embodiments, the retention lever may be configured to pivot relative to the housing to lock the reducer instrument to the distal inserter portion. In certain embodiments, the reducer shaft may include a drive joint configured to couple to an adapter for moving the reducer shaft relative to the housing. In some embodiments, the reducer shaft may include a proximal threaded portion and a distal translation portion, and rotation of the proximal threaded portion may translate the distal portion to engage the spinal rod. Furthermore, in some embodiments, the instrument can provide counter torque during spinal rod reduction.

[0013] In another aspect, a surgical instrument is disclosed that can include a proximal handle, a longitudinal shaft coupled to the handle, and an engagement feature disposed at a distal end of the shaft to engage one or more features of an implant. A sidewall of the engagement feature can define a distally facing recess and can have an internally threaded surface configured to mate with a corresponding feature of the implant to couple the shaft to the implant.

[0014] As with the above-described embodiments, any of a variety of alternative or additional features can be included and are considered within the scope of the present disclosure. For example, in some embodiments, the sidewall can have an externally threaded surface configured to connect to a corresponding feature on the implant to connect the shaft to the implant. In certain embodiments, the internally threaded surface and the externally threaded surface can be located on opposite sides of the sidewall. In some embodiments, the internally threaded surface and the externally threaded surface can be axially offset such that the distal end of the externally threaded surface is positioned proximal to the proximal end of the internally threaded surface. In certain embodiments, the sidewall can taper distally, beginning distally of the externally threaded surface.

[0015] In some embodiments, the sidewall can begin proximal to the internal threaded surface and taper distally.

[0016] In certain embodiments, the engagement feature can include a centering pin extending distally from the engagement feature, and the centering pin can be configured to be received within a portion of the implant.

[0017] In another aspect, a surgical method is disclosed that can include contacting a holder instrument with an implant, the holder instrument having a longitudinal shaft including an engagement surface at a distal end thereof, the engagement surface can have a reduced diameter portion with internal threads. The method can further include threading the holder instrument into a first corresponding feature of the implant, the first corresponding feature can be a surface that corresponds to the internal threads. The method can further include positioning the implant relative to the surgical site using the holder instrument.

[0018] As with the instruments described above, the methods disclosed herein can include any of a variety of additional or alternative steps deemed within the scope of the present disclosure. For example, in some embodiments, the distal end of the holder instrument can include an external thread, and the method can include decoupling the holder instrument from a first corresponding feature and threading the holder instrument into a second corresponding feature of the implant, the second corresponding feature being a surface that corresponds to the external thread. In certain embodiments, the second corresponding feature can include an internal thread formed within a recess of the implant.

[0019] In some embodiments, threading the holder instrument into the first corresponding feature can further include engaging the external threads of the set screw with the internal threads, hi certain embodiments, a centering pin of the engagement surface can be advanced distally into a recess of the set screw.

[0020] In another aspect, a surgical method is disclosed that can include coupling an inserter instrument to an implant having opposing arms defining a recess, such that the inserter instrument contacts only one of the opposing arms to maintain access to the recess. The method can further include using the inserter instrument to position the implant relative to the surgical site such that at least a portion of a fixation element is disposed within the recess of the implant. The method can also include inserting a set screw into the implant to capture the fixation element within the recess of the implant while maintaining the position of the implant using the inserter instrument.

[0021] As with the above-described embodiments, various additional or alternative steps are possible and are considered within the scope of the present disclosure. For example, in some embodiments, the method can include tightening the set screw by rotating the set screw in a first direction relative to the implant while applying a counter torque force to the implant using an inserter instrument.

[0022] In some embodiments, the method may further include decoupling the inserter instrument from the implant.

[0023] Further details are provided below: Any of the features or variations described herein can be applied to any particular aspect or embodiment of the present disclosure in several different combinations. An explicit description of any particular combination is omitted, but this is simply to avoid unnecessary length or repetition. [Brief explanation of the drawings]

[0024] Aspects and embodiments of the present disclosure can be more fully understood from the following detailed description taken in conjunction with the accompanying drawings. [Figure 1A] FIG. 1 is a perspective view of one embodiment of an inserter tool. [Figure 1B] FIG. 1B is an exploded view of the device of FIG. 1A. [Figure 1C] FIG. 1B is a side longitudinal cross-sectional view of the device of FIG. 1A. [Figure 2A] FIG. 1B is a front view of an embodiment of an implant that can be used with the device of FIG. 1A. [Figure 2B] FIG. 2B is a perspective view of the implant of FIG. 2A. [Figure 3] 2B is a perspective view of one embodiment of an inserter tool coupled to the implant of FIG. 2A. [Figure 4A] FIG. 4 is a detailed perspective view of a distal portion of the instrument of FIG. 3. [Figure 4B] FIG. 4 is another detailed perspective view of the distal portion of the instrument of FIG. 3. [Figure 4C] FIG. 4 is a detailed perspective longitudinal cross-sectional view of a distal portion of the instrument of FIG. 3. [Figure 5] FIG. 4 is a detailed perspective longitudinal cross-sectional view of the connection between the inserter tool and the implant of FIG. 3. [Figure 6A] FIG. 1 illustrates a top perspective view of an embodiment of an inserter tool. [Figure 6B] FIG. 6B is an exploded view of the device of FIG. 6A. [Figure 6C] FIG. 6B is a side longitudinal cross-sectional view of the device of FIG. 6A. [Figure 7] 6B is a perspective view of the inserter instrument of FIG. 6A coupled to the implant of FIG. 2A. [Figure 8A] FIG. 12 is a perspective view of one embodiment of a reducer instrument that can be used as a companion instrument to the inserter instrument of the present disclosure. [Figure 8B] FIG. 8B is an exploded view of the reducer device of FIG. 8A. [Figure 8C] FIG. 8B is a side longitudinal cross-sectional view of the device of FIG. 8A. [Figure 9] 8B is a side view of the reducer tool of FIG. 8A coupled to the inserter tool of FIG. 6A. [Figure 10] FIG. 10 is a side view of a drive handle coupled to the assembly of FIG. 9. [Figure 11] 10 is a detailed side longitudinal cross-sectional view of the assembly of FIG. 9 showing the fixation element being reduced into the recess of the implant. [Figure 12]FIG. 1 is a perspective view of one embodiment of an inserter tool. [Figure 13A] FIG. 1 is a perspective view of one embodiment of a holder device. [Figure 13B] FIG. 13B is an exploded view of the holder device of FIG. 13A. [Figure 14] FIG. 13B is a detailed perspective view of a distal portion of the holder device of FIG. 13A. [Figure 15] 13B is a side view of the holder device of FIG. 13A coupled with the connector of FIG. 2A via the internal threads of the engagement feature. [Figure 16] 13B is a side view of the holder device of FIG. 13A coupled with the connector of FIG. 2A via the external threads of the engagement feature. [Figure 17] FIG. 10 is a side longitudinal cross-sectional view of one embodiment of an engagement feature of a holder instrument having an axial offset between the internal and external threads. [Figure 18] FIG. 1 is a perspective view of one embodiment of a holder device. [Figure 19] FIG. 19 is a detailed perspective view of a distal portion of the holder device of FIG. 18. [Figure 20] 19 is a side longitudinal cross-sectional view of an engagement feature of the holder device of FIG. 18. FIG. [Figure 21] FIG. 1 is a perspective view of one embodiment of an inserter tool. [Figure 22A] FIG. 22 is a detailed perspective view of a distal portion of the instrument of FIG. 21. [Figure 22B] FIG. 22 is a detailed perspective longitudinal cross-sectional view of the distal portion of the instrument of FIG. 21. DETAILED DESCRIPTION OF THE INVENTION

[0025] Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices, systems, and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. The devices, systems, and methods specifically described herein and illustrated in the accompanying drawings are non-limiting embodiments. Features illustrated or described in connection with one embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be within the scope of the present disclosure. Additionally, to the extent that linear, circular, or other dimensions are used in describing the disclosed devices and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such devices and methods. Equivalent dimensions can be determined for different geometries, etc. Furthermore, like-numbered components of the embodiments may generally have similar features. Still further, the size and shape of a device and its components may depend at least on the anatomy of the subject with whom the device is used, the size and shape of the object with which the device is used, and the method and procedure for which the device is used.

[0026] Disclosed herein are surgical instruments, systems, and related methods of use for interfacing with an implant during a surgical procedure. The surgical instrument can include an inserter having a handle at a proximal end configured to engage one side of the implant. The inserter can include a control shaft configured to move longitudinally to lock or unlock the connection with the implant. Actuation of the control shaft can be performed by a knob that can control the movement of the control shaft. The inserter can facilitate positioning of the implant relative to the surgical site and can allow for counter torque when applying torque to tighten a set screw or the like. Additional instruments can also be used to manipulate the implant. For example, an auxiliary instrument, such as a reducer instrument, can be coupled to the inserter to facilitate rod reduction, etc. Alternatively or additionally, a holder instrument having a threaded distal engagement feature can be used to couple to the implant during a surgical procedure to facilitate insertion and / or manipulation of the implant.

[0027] 1A-1C illustrate perspective, exploded, and longitudinal cross-sectional views, respectively, of one embodiment of a surgical implant inserter instrument 100. The instrument 100 can include a proximal handle 102 and a distal inserter portion 104. The inserter portion 104 can include an elongated body 106 having a proximal end coupled to the handle 102 and a distal end defining a plurality of locking elements 107 configured to engage with a half-portion of an implant, e.g., a surgical connector configured to connect multiple spinal fixation rods or other elements together, a polyaxial bone screw, other bone anchors, or the like. The locking elements 107 can be configured to engage with a half-portion of an implant, e.g., a single side of a rod slot formed in a connector, as described in more detail below, such that the locking elements 107 mate with the connector to secure the inserter instrument to the implant and facilitate its insertion and manipulation. While this disclosure often refers to surgical connectors, the various instruments disclosed herein may be utilized with other types of implants as well, including various screws, hooks, plates, staples, etc. Additionally, while this disclosure refers to surgical connectors utilized to connect multiple spinal fixation rods, such connectors are also utilized to connect different spinal fixation elements. For example, in some embodiments, one or both of the spinal fixation elements connected by the connector may be a flexible tether.

[0028] The inserter portion 104 can include a control shaft 108 having a distal shaft portion 122 that combines with a locking element 107 to form a clasp on the distal end of the instrument. The control shaft 108 can be movably coupled to the distal inserter portion 104 by a pin 114 that extends through a bore formed in the distal portion of the control shaft 108 and is received in a slot or track 116 formed in the distal inserter portion 104. The control shaft 108 can include a proximal shaft portion 120 that is threadably coupled to the distal shaft portion 122, for example, using external threads 123 formed on the proximal end of the distal shaft portion 122 that mate with internal threads (not shown) formed along a bore in the distal end of the proximal shaft portion 120. The proximal shaft portion 120 can include a threaded proximal portion 166 that can be disposed through a bore formed in the proximal handle 102 and can be coupled to the knob 118. The control shaft 108 may be configured to move longitudinally relative to the inserter portion 104 in response to rotation of a knob 118 or other type of actuation control, thereby locking or unlocking the clasp from the surgical implant, as described in more detail below. A proximal nut 170 or other stop may be coupled to the threaded portion 166 to prevent inadvertent removal of the knob 118 from the proximal shaft portion 120. Additionally, a spring 172 or other biasing element may be configured to bias the control shaft 108 proximally relative to the inserter portion 104 to provide a pre-locking force for mating with the surgical implant, as described in more detail below. A guide 112 is disposed around the control shaft 108 between the spring 172 and the knob 118 and may be configured to translate without rotation, for example, via wings that ride in slots 117 formed in the inserter portion 104. The guide can help ensure that the knob does not impart any rotational force to the spring 172, allowing for smoother operation of the instrument.

[0029] The handle 102 can have a variety of configurations suitable for interfacing directly with various users and / or with surgical robots or other instrumentation, such as manually adjustable clamps or holding fixtures. The handle 102 can be modular so that different types of handles, such as handles configured to interface with humans or machines, or handles of different sizes for different users, can be utilized. Thus, the handle 102 can include a base 124 configured to couple to the inserter portion 104 using, for example, posts that can be received within bores formed in the inserter portion or the like. The handle 102 can also include a gripping or interface portion 126 and a fixed portion 128 that can securely couple the gripping portion 126 to the base 124. In the illustrated embodiment, the fixed portion 128 extends through a bore formed in the gripping portion 126 and threadably couples to a portion of the base 124, although various configurations are possible.

[0030] 2A and 2B illustrate one embodiment of an implant, a surgical connector 200, and a one-sided locking feature that can mate with a distal portion of the inserter instrument 100 to enable selective coupling between the implant and the inserter instrument. The illustrated connector 200 is a rod-to-rod connector that couples multiple rods together, but other types of surgical connectors can be utilized as well, for example, by incorporating features described below to enable coupling with the inserter instrument 100. The implant 200 can include one or more open recesses 202 formed within its body (e.g., for receiving rods and / or set screws therethrough). For example, in some embodiments, as illustrated in FIGS. 2A and 2B, the body can include opposing arms 201 a, 201 b that define the recess 202 therebetween. A one-sided portion of the implant 200 can be a portion of the implant located toward one end of the implant or on one side of the open recess 202, e.g., on arm 201 a. For example, the half portion 205 may correspond to an end portion of the implant 200 opposite or on one side of the open recess 202. By mating with one side of the open recess 202, the recess can remain accessible (e.g., not blocked) after the locking element 107 of the inserter instrument 100 is engaged in the locking configuration. This can allow, for example, a rod and / or set screw 210 to be received in one or more of the recesses 202 while coupled to the inserter instrument 100. Returning to the connector 200, the connector can include a pre-installed set screw 250 that can protrude proximally with threads 252 exposed. In some embodiments, the set screw 250 can be pre-installed on the connector 200, although it will be understood that the set screw 250 can be added to the connector at several different points in the procedure. In some embodiments, the instrument of Figures 13A-20, discussed below, can be utilized to manipulate the connector 200 by coupling to the threads 240 of the connector 200 or the threads 252 of the set screw 250 protruding from the connector body.

[0031] The locking joint of the connector 200 can include a top- or proximally-facing bearing surface 210 and a laterally-facing groove 220. Each of these corresponding locking elements can be configured to contact, mate, interlock, or otherwise engage with a locking element 107, as shown in FIG. 3, thereby restraining movement of the connector 200 relative to the inserter instrument 100. For example, as shown in FIGS. 2A and 2B, the top- or proximally-facing bearing surface 210 can correspond to a top surface of the connector 200, which can partially surround an upper edge of the open recess 202. A pair of laterally-facing grooves 220 can correspond to a pair of vertical grooves formed in the sidewalls of the connector adjacent the open recess 202. The vertical grooves 220 can intersect the recess 202, as shown in FIGS. 2A and 2B, or can be spaced a predetermined distance from the recess 202. A distally facing bearing surface (not shown), such as a locking protrusion formed on the surface of the implant, may also be included, extending transversely between the pair of vertical grooves 220. In some embodiments, connector 200 may also include a horizontal groove or notch 232 formed along the proximal end of one side below the upper or proximally facing bearing surface 210. Further details regarding connectors of the type shown in Figures 2A and 2B, as well as unilateral instrumentation, may be found in U.S. Patent No. 10,966,762, entitled "Unilateral Implant Holders and Related Methods," which is incorporated herein by reference in its entirety.

[0032] 3-5 illustrate in more detail an inserter instrument 3000 coupled to a connector 200. The inserter instrument 3000 can be similar in many respects to the inserter instrument 100. In the illustrated embodiment, for example, only the configuration of the handle 3002 differs from the inserter 100. Accordingly, a detailed description of the inserter 3000 will be omitted, and reference may be made to features illustrated in connection with the inserter 100. While the inserter instrument 3000 can be coupled to a polyaxial screw head or other implant, as discussed above, the inserter instrument 3000 will be discussed below with reference to the connector 200. As shown in FIGS. 3-5, the instrument 3000 can be coupled to the half portion 205 such that the locking element 107 engages the half portion 205 to secure the connector 200 in place. 4A-4C, the inserter portion 104 can include a recess 144 that terminates in or includes a locking element 107 for coupling and uncoupling with the connector 200. The elongated body 106 of the inserter portion 104 can terminate in a forked tool tip 146 that can include a pair of parallel arms 148a, 148b (collectively 148). The spacing and dimensions of the arms 148 can be configured to form an implant-receiving pocket 150 between opposing sides of the arms 148. The pocket 150 can be configured to correspond to the width and depth of one side portion 205 of the connector 200.

[0033] The distal portion of the elongated body 106 of the inserter portion 104 can include a horizontal stop beam 154 extending transversely between opposing faces of the arms 148. The height of the stop beam 154 relative to the distal ends of the arms 148 can be configured to correspond, or at least partially correspond, to the height of the connector half portion 205. The stop beam 154 can have a distally facing bearing surface 156 configured to contact the connector's top or proximal bearing surface 210, thereby restraining longitudinal movement (e.g., upward movement) of the connector in the proximal direction. The stop beam 154 can have a shape that matches the shape of the connector's top bearing surface 210. For example, if the connector's top bearing surface 210 forms the outer edge of the open recess 202 for receiving a rod and / or set screw, the forward and distal faces of the stop beam 154 can be shaped so that the stop beam 154 does not block or otherwise interfere with the connector's open recess 202.

[0034] Forked instrument tip 146 may include a pair of opposing insertion tabs 160a, 160b (collectively 160) that project longitudinally along opposing faces of arm 148 at or adjacent to the front of pocket 150. Insertion tab 160 may have lateral bearing surfaces configured to fit into and slide along corresponding lateral grooves 220 formed in one side portion of the connector, thereby restraining lateral movement (e.g., side-to-side and anterior-posterior) of the implant.

[0035] The locking element 107 may include a retractable hook 162 formed along a distal portion of the control shaft 108 and disposed between opposing surfaces of the arm 148 at or adjacent the rear of the pocket 150. The hook 162 may be configured to mate with a groove or notch 232 formed on the connector 200. The retractable hook 162 may be configured to move proximally relative to the inserter portion 104 and laterally toward the connector (e.g., upward and inward) when moving from an unlocked configuration to a locked configuration in which the hook 162 is disposed within the groove 232 of the connector 200. The retractable clasp 162 may be configured to move distally relative to the inserter portion 104 and laterally away from the connector (e.g., downward and outward) when moving from a locked configuration to an unlocked configuration in which the connector may be separated from the instrument. Movement of the hook 162 relative to the elongate body 106 of the inserter portion 104 can be controlled by the shape of a track 116 that receives a pin 114 disposed through a bore in the distal portion of the control shaft 108 that contains the hook 162. For example, by shaping the track 116 to be inclined or angled relative to the longitudinal axis of the inserter portion 104, the distal portion of the control shaft 108 that contains the hook 162 can be made to move in a second direction when translated distally and proximally relative to the inserter portion.

[0036] The locking of retractable hook 162 to connector 200 is shown in more detail in FIG. 5. To secure connector 200 to instrument 100, retractable hook 162 may be initially positioned on the proximal end of connector 200 or other implant such that receiving pocket 150 is aligned with connector half 205. As inserter instrument 100 is advanced distally toward connector 200, insertion tab 160 of arm 148 may slide longitudinally along transverse groove 220 of the locking joint, thereby guiding connector half 205 proximally into pocket 150.

[0037] Translation of control shaft 108 and hook 162 formed thereon can be controlled by rotation of knob 118 and / or manual manipulation of the control shaft against the biasing force of spring 172. For example, when assembled, spring 172 can apply a proximally directed biasing force to control shaft 108, e.g., by being compressed between elongate body 106 of inserter portion 104 and guide 112, thereby applying a force to knob 118. This can provide a pre-locking force to instrument 100 such that control shaft 108 and hook 162 must be advanced distally against the biasing force of the spring to allow coupling with connector 200, and once the biasing force is restored, they tend to couple with any correctly positioned connector without further user engagement.

[0038] Thus, in one embodiment, coupling a connector or other implant to the inserter instrument 100 can include a user distally advancing the control shaft 108 against the biasing force of the spring 172, for example, by manually pushing the knob 118 to distally advance the knob and the control shaft 108, which is threadably coupled to the knob. The connector 200 or other implant can then be positioned relative to the distal end of the inserter instrument 100 so that the forked distal tip engages the lateral groove in the half portion 205 of the connector 200 or other implant. The user can then release the force utilized to overcome the biasing force of the spring 172. The spring 172 then biases the control shaft 108 proximally against the inserter portion 104, causing the hook 162 to move proximally and engage the groove 232 formed in the half portion 205 of the connector or other implant.

[0039] To securely couple the connector 200 and the inserter instrument 100 beyond the provisional coupling provided by the spring 172, the user can rotate the knob 118 until the distal surface of the knob 118 abuts the proximal surface of the inserter portion 104. This can ensure that distal movement of the control shaft 108 relative to the inserter portion 104 is not possible, thereby locking the instrument 100 against uncoupling from the connector 200.

[0040] Releasing the connector 200 or other implant from the instrument 100 can include rotating the knob 118 in the opposite direction to introduce a gap between the distal end of the knob 118 and the proximal surface of the inserter portion 104. This can return the instrument to a provisionally locked state on the connector or other implant. To fully uncouple the connector, the user can again advance the knob 118 and control shaft 108 distally against the biasing force of the spring 172 to disengage the hook 162 from the groove 232 of the connector 200, thereby allowing the connector to be separated from the inserter instrument 100.

[0041] As shown in FIG. 5 , the connector 200 can be advanced proximally relative to the elongated body 106 of the inserter portion 104 during coupling until the distally facing bearing surface 156 of the stop beam 154 contacts or abuts the upper or proximal bearing surface 210 of the connector locking joint. When the connector upper bearing surface 210 contacts or abuts the stop beam 154, the retractable hook 162 can be engaged to lock the connector in place. To do this, the control shaft 108 can be withdrawn proximally (e.g., via a biasing force from the spring 172 and / or via actuation from the knob 118). As the control shaft translates proximally relative to the inserter portion 104, the pin 114 can ride within the slot 116 of the elongated body 106 of the inserter portion 104 to control the movement of the retractable hook 162 from an unlocked configuration to a locked configuration relative to the connector. Pin 114 can be configured to protrude from at least one of the laterally opposed faces of control shaft 108 into a slot 116 formed in a distal portion of elongated body 106 of inserter portion 104. As described above, slot 116 can include an angled portion extending obliquely relative to the longitudinal axis of the instrument. Thus, movement of pin 114 along slot 116 can result in movement of hook 162 both along and transverse to the longitudinal axis of the instrument (e.g., toward or away from the central axis of the connector, inward or outward).

[0042] To lock the inserter instrument 100 to the connector 200 or other implant, the retractable hook 162 is pulled upward (i.e., proximally along the longitudinal axis of the instrument 100) and inward (i.e., transverse to the longitudinal axis of the instrument 100 and toward the longitudinal axis of the connector 200) to the locking configuration, thereby engaging the hook 162 with a groove 232 formed in the connector 200. In this locking configuration, the connector 200 is captured and restrained from movement in all directions, thereby securely coupling the connector 200 to the inserter instrument 100, thereby allowing the instrument to be utilized to remotely manipulate the connector's position (i.e., a user grasping the proximal end of the instrument 100 can control the position of the connector 200 coupled to the distal end of the instrument). The inserter instrument 100 can leave the recess 202 of the connector 200 unobstructed, allowing for placement of a spinal rod, set screw, tether, other fixation element, etc. therein. In some embodiments, the inserter instrument 100 can be configured to provide a counter torque during insertion and tightening of the set screw 250 into the recess 202 of the connector 200. For example, as a user tightens the set screw by rotating it in a first direction (e.g., via a screwdriver, etc.), the user can simultaneously resist rotation or other movement of the connector 200 or other implant by applying a counter torque (e.g., a force in a second direction opposite the first direction) through the inserter instrument 100. The above-described rigid connection between the inserter instrument 100 and the connector 200, which constrains relative movement in all directions, can enable the user to apply an effective counter torque to the connector 200 via the inserter instrument 100. When the user has finished manipulating the connector 200 using the instrument 100 (including utilizing any secondary or auxiliary instrumentation as described herein), the inserter instrument 100 can be separated from the connector 200 by advancing the retractable hook 162 distally using the knob 118 and / or by manually advancing the control shaft 108 toward the unlocked configuration against the biasing force of the spring 172.

[0043] 6A-6C and 7 illustrate another embodiment of a unilateral inserter instrument 100'. As previously mentioned, the instrument 100' may be similar in many respects to the inserter instrument 100, and as a result, a detailed description of every feature will be omitted for the sake of brevity. In the inserter instrument 100', a locking handle 118' combined with a release button 119' is provided in place of the knob 118 for actuating the inserter instrument 100'. The locking handle 118' may be received in a recess in the handle 102'. The locking handle 118' may include a body 120' having an extension 124' configured to be received in the hollow interior 121 of the inserter instrument 100'. The extension 124' may include a plurality of holes 126' therein that may receive one or more pins 129 to pivotally connect the extension 124' to the inserter portion 104' and the control shaft 108, thereby allowing controlled relative movement between these components.

[0044] As seen in the longitudinal cross section of FIG. 6C , locking handle 118′ can be pivotally coupled to inserter portion 104 by pin 129 and can also be pivotally coupled to control shaft 108, so that actuation of the locking handle, for example, by pushing it into handle 102′, retracts control shaft 108 proximally so that connector 200 can be securely coupled to instrument 100′. A spring 181, such as a leaf spring, can provide a biasing force to maintain locking handle 118′ in an extended state in which instrument 100′ is in the unlocked configuration and ready to receive connector 200. Locking handle 118′ can include a ratchet 182 formed on its interior surface that can mate with a pawl 183 that is part of release button 119′. The release button 119' is biased to keep the pawl 183 connected to the ratchet 182 until a user depresses the release button 119' to overcome the biasing force of the spring 134' and move the pawl 183 away from the ratchet 182. This also allows the spring 181 to return the locking handle 118' to its unlocked configuration.

[0045] The inserter portion 104 can include one or more attachment features extending therefrom for coupling the instrument 100 to one or more auxiliary instruments. As shown in FIG. 7 , the attachment feature can include a pin 180 extending from the body 106 configured to be coupled to an auxiliary instrument. FIGS. 8A-8C illustrate one embodiment of a reducer instrument 300 that can be used with the presently disclosed inserter instrument. As shown, the reducer instrument 300 can include a reducer shaft 301 disposed within a housing 303 configured to be coupled to the inserter instrument 100, as discussed in more detail below.

[0046] The reducer shaft 301 can include a generally cylindrical shaft having a proximal end 301p and a distal end 301d, with an inner lumen or working channel 302 extending therethrough. The reducer shaft 301 can have an outer diameter D1 that is smaller than a diameter D of a channel 305 formed in the housing 303 such that the reducer shaft 302 can be inserted through the channel 305. In operation, at least a portion of the reducer shaft 302 can be rotated relative to the housing 303 about an axis A1 to advance the reducer shaft 302 distally relative to the instrument body and the connector 200 fixed thereto, thereby urging the rod toward a rod seat of the connector 200. The reducer shaft 301 can include a proximal portion 304 configured to rotate relative to the housing 303 and a distal portion 306 configured to remain in a fixed rotational position relative to the housing 303. The fixed rotational position can be one in which opposing arms 307 a, 307 b of distal portion 306 align with the rod to reduce it into connector 200. As mentioned above, reducer shaft 301 can be cannulated or can define a working channel therethrough to, for example, allow reducer shaft 301 to be inserted over a guidewire or to allow an instrument, implant, or other object to be inserted therethrough. For example, reducer shaft 301 can allow a set screw or other closure mechanism, and an instrument for applying the set screw or closure mechanism, to pass through lumen 302 to apply the set screw or closure mechanism to the connector.

[0047] The proximal portion 304 may include a drive joint 308 that facilitates applying a torque or other force to the reducer shaft 302, for example, to advance the reducer shaft 302 along corresponding threads 309 of the housing 303 during rod reduction. The drive joint 308 may have any geometry that facilitates applying a torque or other force to the reducer shaft 302, such as a hex drive 310 as shown. The drive joint 308 may be received within or otherwise coupled to an instrument to apply a driving force to the proximal portion 304.

[0048] The proximal portion 304 may include a flange or shoulder 314 for limiting the extent to which the proximal portion 304 can be received within a corresponding drive joint of the instrument, as described further below. The proximal portion 304 may include external threads 316 configured to mate with threads 309 of the housing 303. The proximal portion 304 may include a coupler 318 for attaching the proximal portion 304 to the distal portion 306. The coupler 318 may be configured to attach the proximal portion 304 and the distal portion 306 to prevent relative longitudinal translation therebetween, while still allowing free rotation of the proximal portion 304 relative to the distal portion 306 about axis A1. As shown, the connector 318 can include a plurality of pins 322 that are received within openings 324 in the proximal portion and extend into circumferential grooves 325 formed in the distal portion to constrain the proximal and distal portions 304, 306 against relative translation while allowing relative rotation.

[0049] A second coupler 380 may be provided to selectively prevent relative rotation between the distal portion 306 and the housing 303 while allowing relative translation between these components. For example, one or more pins 381 may be received within openings 382 formed in the housing 303 and extend into corresponding longitudinal grooves 383 formed in the distal portion 306 to constrain the housing 303 and distal portion 306 against relative rotation while allowing relative translation.

[0050] As described above, distal portion 306 may include one or more arms 307a, 307b (collectively 307) extending distally therefrom. Arms 307 may be configured to contact and bear against a spinal rod to urge the rod distally as reducer shaft 301 translates distally within housing 303. The distal contact surface of arms 307 may be shaped to match the rod used with reducer shaft 301. For example, arms 307 may include a circular notch having a diameter corresponding to the rod diameter. Although two arms 307a, 307b are shown, reducer shaft 302 may include any number of rod-engaging arms.

[0051] 8C , the outer housing 303 may include threads 309 configured to mate with the threads 316 to control movement of the reducer shaft 302 through the housing 303. The housing 303 may include one or more sets of arms extending therefrom to couple the reducer instrument 300 with the inserter instrument 100. For example, as shown, the housing 303 may include a first set of arms 326 a, 326 b (collectively 326) on the proximal end 303 p of the housing and a second set of arms 328 a, 328 b (collectively 328) on the distal end 303 d of the housing 303, configured to engage the inserter instrument 100 therebetween. Each pair of arms 326, 328 may define a recess 330 configured to receive a portion of the inserter instrument 100′ therein. The inwardly facing surfaces of the arms 326, 328 may include a recessed track 332 for receiving one of the pins 180 extending from the elongated body 106 of the inserter instrument 100′. The recessed track 332 may be formed in the arms 326, 328 such that the pin 180 enters and slides in a direction toward the housing 303 to position the reducer instrument 300 relative to the inserter instrument 100.

[0052] A retention lever 336 may be coupled to the housing 303 to switch the reducer device 300 between an unlocked configuration and a locked configuration. For example, the retention lever 336 may pivot relative to the housing 303 to lock the pin 180 within the recessed track 332 to lock the reducer device 300 to the inserter device 100′ in a locked configuration and to release the pin 180 from the recessed track 332 to unlock the reducer device 300 from the inserter device 100. The retention lever 336 may include a body 338 configured to be disposed about the housing 303. The retention lever 336 may be coupled to the housing 303 by a pair of pins 340 received in corresponding openings 342 in the arms 326, 328. A biasing element, e.g., a spring 344, may be disposed between the retention lever 336 and the arms 326, 328 to exert a biasing force on the retention lever 336. The biasing force can maintain the lever 336 in a locked configuration that blocks entry to the track 332. In this manner, a user must actuate the lever 336 to open the opening to the track 332 and allow coupling of the housing 303 to the inserter instrument 100′. This is in contrast to the lower arm 326, which always has an open track 332 formed therein. This facilitates the coupling sequence in which a user slides the lower pin of the inserter instrument 100′ into the track 332 of the arm 326 and then pivots the reducer instrument 300 so that the upper arm 328 moves toward the inserter instrument and its upper pin. The user then actuates the lever 336, allowing the upper pin to slide into the track 332 of the upper arm 328. Releasing the lever 336 with the pin disposed within the track 332 prevents the pin from disengaging from the track 332, thereby maintaining the reducer device 300 in a predetermined position relative to the inserter device 100'.

[0053] 9-11 illustrate one embodiment of the connection between the inserter instrument 100′ and the reducer instrument 300. As shown, arms 326, 328 extending from the housing 303 of the reducer instrument 300 can receive the distal inserter portion 104 therebetween. The pin 180 can facilitate connection to the reducer instrument 300 by sliding along recessed tracks 332 in the arms 326, 328 until the connection is complete, as described above.

[0054] Once connection is achieved, one or more instruments may be utilized in conjunction with the reducer shaft 301 to reduce the spinal rod into the connector. As shown in FIGS. 10 and 11 , a spinal rod 350 may be reduced into the connector 200′ using the reducer instrument 300. (Although a different type of connector is shown having a single-opening recess for receiving the rod and a second rod component extending laterally therefrom, as noted above, any of a variety of connectors or other implants may be utilized with the devices, systems, and methods disclosed herein.) Reduction may be accomplished using a drive handle 400 (or other driver, such as a power driver) coupled to the drive joint 308 to reduce the spinal rod 350 while the inserter instrument 100′ is docked to the connector 200′ to provide counter torque if necessary. During reduction, the drive handle 400 can be rotated relative to the housing 303 to advance the reducer shaft 302 distally, which advances the distal portion 306 into contact with the spinal rod 350 and forces the rod 350 into a recess in the connector 200'.

[0055] The instruments 100, 3000 shown in FIGS. 1-5 are not shown with the pin 180 utilized to couple to a secondary instrument, such as the reducer 300. However, such a feature is certainly contemplated for inclusion with the inserter instruments 100, 3000 previously described. FIG. 12 illustrates an embodiment of an inserter instrument 100″ that is similar to the inserter instrument of FIGS. 1-5 (e.g., utilizing a rotary knob actuator with a trigger actuator selected), but includes a pin 180 for coupling to a secondary or auxiliary instrument, such as the reducer 300. The inserter instrument 100″ also includes an alternative form of track 116″ that extends through the entire thickness of the distal portion of the inserter portion 104, rather than extending only partially through the interior thereof, thereby allowing the path of the track 116″ to be seen from a side view of the instrument. This may be done for a variety of reasons, including allowing for a deeper track that can accept a longer pin for greater strength, simplifying the manufacturing process (e.g., forming a blind track on its inner-facing surface as opposed to milling the track through the thickness of the distal portion of the instrument), etc.

[0056] 13A and 13B illustrate one embodiment of a holder instrument 500 of the present disclosure. The holder instrument 500 can couple to a connector 200 or other implant, allowing it to be introduced to a surgical site and attached to various hardware. The holder instrument 500 can include a distal engagement feature or surface 502 for coupling to a connector 200 to facilitate controlled insertion and / or manipulation of the connector 200 during a surgical procedure. The holder instrument 500 can include a longitudinal shaft 504 coupled to a proximal handle 506. The engagement feature 502 can be disposed on a distal end 504d for coupling one or more connectors 200 to the handle 506. The engagement feature 502 can include a centering pin 508 configured to be received within the connector 200. The proximal end 504p of the longitudinal shaft 504 may include a threaded surface 510 for engaging corresponding threads formed on the inner surface of the proximal handle 506 to couple the longitudinal shaft to the proximal end.

[0057] FIG. 14 illustrates the engagement feature 502 in more detail. As shown, the engagement feature 502 can include both external and internal threads for coupling the holder device 500 to the externally and internally threaded mating of the connector 200, although, as described below, in some embodiments, external threads may not be present. For example, the engagement surface 502 can include a reduced diameter portion 507 defining an opening 512 and an associated recess 514 at the distal end of the longitudinal shaft 504 for receiving a centering pin 508 therein. The centering pin 508 can resemble a substantially cylindrical post that extends into a recess of the connector 200 (e.g., the set screw drive feature recess 254 as shown in FIG. 2B ). As shown, the opening 512 can surround the centering pin 508 such that an annular recess 514 is formed around the pin 508 that can receive a portion of the connector.

[0058] The reduced diameter portion 507 may include one or more threaded surfaces for threadably disposing the engagement surface within or engaging the connector 200. In certain embodiments, as illustrated in FIG. 14 , the multiple threaded surfaces may form mating threads that may allow the holder device 500 to be used with connectors in a variety of ways. As shown, the engagement surface 502 may include internal threads 516 and external threads 518 disposed on the reduced diameter portion 507. The internal threads 516, or internal threads, may extend along an inner surface of the reduced diameter portion 507 and may be utilized to interlock with the threads of the set screw 250 of the connector 200 that protrudes from the proximal surface of the connector. 15 , the engagement surface 502 can engage with the set screw 250 (not visible, see FIGS. 2A and 2B ) of the connector 200 by inserting the centering pin 508 into the opening 254 of the set screw 250, with the internal threads 516 engaging the external threads 252 of the set screw 250 for threading the holder device 250 thereon. In this configuration, the centering pin 508 can be received within the opening 254 of the set screw 250, with the set screw 250 disposed within the annular recess 514 between the centering pin 508 and the internal threads 516. The placement of the centering pin and the threaded coupling of the holder device 500 and the set screw 250 can facilitate a rigid connection between the holder device 500 and the connector 200, thereby allowing a user to remotely manipulate the connector 200 using the holder device 500. Furthermore, when a user connects or disconnects the holder device 500 and the connector 200 via the set screw 250, there may be a mismatch between the amount of force required to rotate the set screw 250 relative to the connector 200 and the amount of force required to rotate the holder device 500 relative to the set screw 250, so as to prevent the user from unintentionally rotating the set screw 250 relative to the connector 200.

[0059] The external threads 518, or male threads, can be used to thread into the internal threads 240 of the connector 200. As shown in FIG. 16 , the external threads 518 can be threaded into corresponding internal threads 240 of the connector 200 or other implant to couple the holder instrument 500 thereto.

[0060] 17 illustrates an alternative embodiment of the engagement surface 502 of the holder instrument 500 that axially offsets the locations of the internal threads 516 and external threads 518 to increase the wall thickness of the instrument along its distal portion. As shown in FIG. 17, the reduced diameter portion 507 of the holder instrument 500 can extend beyond the distal end of the external threads 518 to create an extension 520 with a smooth outer wall. The internal threads 516 can be formed in the extension 520 such that the internal threads 516 terminate proximally at a location axially aligned with or distal to the distal-most external threads 518 (i.e., the proximal-most internal thread 516 is positioned at the same point as or distal to the distal-most external thread 518 when mapped along the longitudinal axis of the instrument 500). This can ensure that there is no position along the length of reduced diameter portion 507 where internal threads 516 are axially aligned with external threads 518 (i.e., overlapping each other when mapped along the longitudinal axis of instrument 500). This may be desirable because positioning the internal and external threads in axial alignment with each other (i.e., overlapping each other when mapped along the longitudinal axis of instrument 500) may reduce the thickness of the material forming the reduced diameter portion, which may increase the likelihood of failure under load. Axially offsetting internally threaded portion 516 and externally threaded portion 518 can allow for a greater material wall thickness to be used throughout reduced diameter portion 507.

[0061] 17 also shows a smaller threaded bore 522 that is used to connect centering pin 508 to reduced diameter portion 507. For example, centering pin 508 can include threads 524 (as shown in FIG. 13B) formed on its proximal end, which can be received within threaded bore 522.

[0062] The outer wall of extension 520, in some embodiments, can have a tapered shape, with a diameter that decreases toward the distal end of the extension. This shape can allow extension 520 to extend deeper into recess 202 of a connector or other implant when holder instrument 500 is coupled to the connector or other implant, for example, by engaging external threads 518 with internal threads 240 of connector 200. The taper can prevent interference when the holder instrument is advanced into the recess, and in some embodiments, the tapered outer surface of extension 520 can abut a corresponding tapered inner surface of connector recess 202, thereby strengthening the connection between the components.

[0063] FIG. 18 illustrates another embodiment of a holder instrument 500′ of the present disclosure. The holder instrument 500′ can couple to a connector 200 or other implant to allow the connector 200 or other implant to be introduced into a surgical site and coupled to other components, anatomical structures, etc. The holder instrument 500′ can include a distal engagement feature or surface 502′ for coupling to the connector 200 or other implant to facilitate controlled insertion and / or manipulation of the implant during a surgical procedure. The holder instrument 500′ can include a longitudinal shaft 504′ coupled to a proximal handle 506′. The engagement feature 502′ can be disposed on a distal end 504d′ for coupling one or more connectors 200 or other implants to the handle 506′. The engagement feature 502′ can include a centering pin 508′ configured to be received within the connector 200. In some embodiments, the proximal end 504p' of the longitudinal shaft 504' can include a threaded surface (not shown) for engaging corresponding threads formed on the inner surface of the proximal handle 506' to couple the longitudinal shaft thereto. In many respects, the holder instrument 500' can be similar to the holder instrument 500 described above, and a detailed description will be omitted to avoid repetition.

[0064] FIG. 19 illustrates the engagement feature 502 in more detail. As shown, the engagement feature 502′ can include threads for coupling the holder instrument 500′ to a threaded joint of the connector 200 or other implant. For example, the engagement surface 502′ can include a reduced diameter portion 507′ defining an opening 512′ at the distal end of the longitudinal shaft 504′ for receiving the centering pin 508′ therein. The centering pin 508′ can resemble a substantially cylindrical post that extends into a recess in the connector 200 (e.g., the set screw drive feature recess 254 as shown in FIG. 2B ). As shown, the opening 512′ can surround the centering pin 508′ such that an annular recess 514′ is formed around the pin 508′ that can receive a portion of the connector.

[0065] Reduced diameter portion 507' can include a threaded surface for coupling the engagement surface with connector 200 or another implant. As shown, engagement surface 502' can include internal threads 516 disposed on reduced diameter portion 507'. As shown, centering pin 508' can advance into a recess formed in connector 200 or another implant, and internal threads 516' can mate with external threads on the connector or another intermediate component. For example, internal threads 516' can extend along the inner surface of reduced diameter portion 507' and can be utilized to couple with threads of, for example, set screw 250 of connector 200 that protrudes from the proximal surface of the connector. For example, the engagement feature 502' can engage with the set screw 250 of the connector 200 (see FIGS. 2A and 2B ) by inserting the centering pin 508' into the opening 254 of the set screw 250, with the internal threads 516' engaging the external threads 252 of the set screw 250 for threading the holder device 250 thereon. In this configuration, the centering pin 508' can be received within the opening 254 of the set screw 250, with the set screw 250 disposed within the annular recess 514 between the centering pin 508 and the internal threads 516'. The placement of the centering pin and the threaded connection of the holder device 500' and the set screw 250 can facilitate a rigid connection between the holder device 500' and the connector 200, thereby allowing a user to remotely manipulate the connector 200 using the holder device 500'. Furthermore, there may be a mismatch between the amount of force required to rotate the set screw 250 relative to the connector 200 and the amount of force required to rotate the holder device 500' relative to the set screw 250, so that the user does not unintentionally rotate the set screw 250 relative to the connector 200 when connecting or disconnecting the holder device 500' to the connector 200 via the set screw 250.

[0066] FIG. 20 illustrates the connection of a centering pin 508′ to a holder instrument 500′. As shown, the reduced diameter portion 507′ of the holder instrument 500′ can create an extension 520′ with a smooth outer wall. The internal threads 516′ can be formed within the extension 520′ on its inner surface without extending onto the outer wall. Utilizing only the internal threads 516′ can maximize the thickness of the material forming the reduced diameter portion while also allowing for a tapered outer diameter distally along the extension 520′. That is, the diameter D′ of the internal threads 516′ can be smaller than the outer diameter D1′ of the reduced diameter portion 507′. Additionally, the outer diameter D1′ can decrease from the proximal end of the extension 520′ to its distal end. FIG. 20 also shows a smaller threaded bore 522′ used to connect the centering pin 508′ to the instrument 500′. For example, centering pin 508 ′ can include threads 524 ′ formed on its proximal end, which can be received within threaded bore 522 .

[0067] FIG. 21 illustrates another embodiment of an inserter instrument 100'". The inserter instrument 100'" can be similar in many respects to the inserter instruments 100, 300, and as a result, a detailed description of every feature will be omitted for the sake of brevity. For example, the inserter instrument 100'" can be coupled to a half portion 205 of a connector 200 or other implant such that a locking element 107'" engages the half portion 205 to secure the connector 200 or other implant in place. A distal portion of the inserter instrument 100'" that couples with the connector 200 is shown in detail in FIGS. 22A and 22B. As discussed above, the inserter portion 104'" can include a recess 144'" that terminates in or includes a locking element 107'" for coupling or uncoupling the connector 200. The elongated body 106''' of the inserter portion 104 can terminate in a forked instrument tip 146''' that can include a pair of parallel arms 148a'''', 148b'''' (collectively 148). The spacing and dimensions of the arms 148'''' can be configured to form an implant-receiving pocket 150'''' between opposing sides of the arms 148''''. The pocket 150'''' can be configured to accommodate the width and depth of one side 205 of the connector 200 or other implant.

[0068] The locking element 107''' may include a retractable hook or clasp 162''' formed along a distal portion of the control shaft 108''' and disposed between opposing surfaces of the arm 148''' at or adjacent the rear of the pocket 150'''. The hook 162''' may be configured to mate with a groove or notch 232 formed on the connector 200. The retractable hook 162''' may be configured to move proximally relative to the inserter portion 104''' and laterally toward the connector (e.g., upward and inward) when moving from an unlocked configuration to a locked configuration in which the hook 162''' is disposed within the groove 232 of the connector 200. The retractable hook 162''' may be configured to move distally relative to the inserter portion 104 and laterally away from the connector (e.g., downward and outward) when moving from a locked configuration to an unlocked configuration in which the connector may be separated from the instrument.

[0069] Recess 144''' can be wider than recess 144 to provide a more robust lead-in surface for locking element 107''' of inserter portion 104'''. Additionally, locking element 107''' can also be wider (e.g., extend further from the side of elongate body 106''') than locking element 107 to increase the robustness of inserter instrument 100'''. For example, once inserter instrument 100''' is locked to an implant, such as half portion 250 of connector 200, the distal portion of inserter portion 104''' can be subjected to various forces during controlled insertion, manipulation, and / or counter-torquing of the implant during a surgical procedure. Widening the distal portion of the instrument, including locking element 107''', can help the instrument better handle these various forces without undesired movement, deflection, etc. In some embodiments, the transition between the larger and smaller connector capture openings can be gradual or smooth to prevent the connector from sticking against a more abrupt transition (e.g., a step or small radius curved transition).

[0070] The elongate body 106''' can include a track 116''' that extends through the entire thickness of the distal portion of the inserter portion 104''', thereby allowing the path of the track 116''' to be visible from a side view of the instrument. As described above with respect to FIG. 12 and the inserter 100'', this track configuration can be utilized to maximize the length of a pin or protrusion formed on the control shaft 108''' that rides within the track, to simplify the manufacturing process, etc. Furthermore, as described above with respect to the track 116, the track 116''' can be inclined or angled relative to the longitudinal axis of the inserter portion 104''' such that the distal portion of the control shaft 108''', including the hook 162''', can be moved in a second direction when translated distally and proximally relative to the inserter portion.

[0071] The various devices and methods disclosed herein can be used in minimally invasive and / or open surgery. Although the various devices and methods disclosed herein are generally described in the context of surgery on a human patient, the methods and devices disclosed herein can be used in any of a variety of surgical or non-surgical procedures with any human or animal subject.

[0072] The various devices disclosed herein may be constructed from any of a variety of known materials. Exemplary materials include materials suitable for use in surgical applications, including metals such as stainless steel, titanium, nickel, cobalt chromium, or alloys and combinations thereof, polymers such as PEEK, ceramics, carbon fiber, etc. Additionally, a variety of manufacturing methods may be utilized, including 3D printing or other additive manufacturing techniques, as well as more traditional manufacturing techniques including molding, stamping, casting, machining, etc.

[0073] The various devices or components disclosed herein may be designed to be disposed of after a single use, or they may be designed to be used multiple times. In either case, however, the various devices or components may be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly, followed by cleaning or replacement of particular parts, and subsequent reassembly. In particular, devices or components may be disassembled, and any number of the particular parts may be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, the device or component may be reassembled for subsequent use at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Reconditioning of devices or components may utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. Use of such techniques, and the resulting reconditioned devices or components, are within the scope of the present disclosure.

[0074] The various devices or components described herein can be processed before use in a surgical procedure. For example, new or used devices or components can be obtained and cleaned as needed. The devices or components can be sterilized. In one sterilization technique, the devices or components can be placed in a closed and sealed container, such as a plastic bag or a TYVEK bag. The container and its contents can be placed in a radiation field that can penetrate the container, such as gamma rays, X-rays, or high-energy electrons. The radiation can kill bacteria on the device or component and within the container. The sterilized device or component can be stored in the sterile container. The sealed container can keep the device or component sterile until it is opened in a medical facility. Other forms of sterilization are also possible, including beta or other radiation, ethylene oxide, steam, or a liquid bath (e.g., cold immersion). Certain forms of sterilization techniques may be more suitable for use with different devices or components, or portions thereof, due to the materials utilized, the presence of electrical components, etc.

[0075] In this disclosure, phrases such as "at least one of" or "one or more of" may be used in conjunction with a conjunctive list of the preceding elements or features. The term "and / or" may also be used with a list of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it is used, such phrases are intended to refer to any of the listed elements or features individually, or any of the listed elements or features in combination with any other listed elements or features. For example, the phrases "at least one of A and B," "one or more of A and B," and "A and / or B" are each intended to mean "A alone, B alone, or A and B together." A similar interpretation is also intended for lists containing more than two items. For example, the phrases "at least one of A, B, and C," "one or more of A, B, and C," and "A, B, and / or C" are each intended to mean "A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together." Additionally, use of the phrase "based on" is intended to mean "based at least in part on," such that unrecited features or elements are acceptable.

[0076] Further features and advantages based on the above-described embodiments are possible and are within the scope of the present disclosure. Therefore, the present disclosure is not limited by what has been specifically shown and described. All publications and references cited herein are incorporated herein by reference in their entirety, except for any definitions, disclaimers, or denials of subject matter, and except to the extent that the incorporated material contradicts the explicit disclosure of this specification, in which case the language of the present disclosure shall prevail.

[0077] Examples of the above-described embodiments may include the following. 1. A surgical instrument comprising: a proximal handle; a distal inserter portion having an elongated body defining a hollow interior, the distal inserter portion having an opening for receiving a portion of the proximal handle therein; a locking portion configured to engage one side portion of the implant; a control shaft received within the hollow interior, the control shaft configured to translate distally to engage the implant engaged by the locking portion; a knob configured to engage the proximal end of the control shaft to translate the control shaft relative to the distal inserter portion, transition the locking portion from an unlocked configuration to a locked configuration, and secure the locking portion to the implant. 2. The surgical instrument of Example 1, wherein the locking portion further comprises a retractable clasp that slides along the surface of the implant during distal translation of the control shaft to engage a groove formed within the implant. 3. The surgical instrument of Example 2, wherein the locking configuration further comprises pulling the retractable clasp upwardly and inwardly to press a proximally-facing bearing surface of the clasp against a distally-facing bearing surface of the implant. 4. A surgical instrument according to any one of Examples 1 to 3, wherein the locking portion further comprises one or more insertion tabs and a stop beam, the insertion tabs being configured to engage and lock onto a surface of the implant, and the stop beams being configured to abut the implant to prevent further translation of the control shaft. 5. The surgical instrument of any of Examples 1-4, wherein the distal inserter portion includes one or more attachment features extending from the distal inserter portion, the attachment features configured to be received within an auxiliary instrument for coupling to the auxiliary instrument. 6. The surgical instrument of Example 5, wherein the one or more attachment features further comprise one or more pins extending from the body of the distal inserter portion. 7. The surgical instrument of Example 5, further comprising a reducer instrument that engages with the one or more attachment features, the reducer instrument having a reducer shaft received within the housing for reducing the spinal rod into the implant. 8. The surgical instrument of Example 7, wherein the housing further comprises one or more arms extending from the housing, the arms having one or more tracks for receiving one or more mounting features therein. 9. The surgical instrument of Example 7, wherein the reducer instrument further comprises a retaining lever coupled to the housing to facilitate locking the reducer instrument to the one or more attachment features. 10. The surgical instrument of example 9, wherein the retention lever is configured to pivot relative to the housing to lock the reducer instrument to the distal inserter portion. 11. The surgical instrument of example 7, wherein the reducer shaft comprises a drive joint configured to couple to an adapter for moving the reducer shaft relative to the housing. 12. The surgical instrument of Example 7, wherein the reducer shaft includes a proximal threaded portion and a distal translating portion, and wherein rotation of the proximal threaded portion translates the distal portion to engage the spinal rod. 13. The surgical instrument of Example 12, wherein the instrument provides counter torque during spinal rod reduction. 14. A surgical instrument comprising: a proximal handle; a longitudinal shaft coupled to the handle; an engagement feature disposed on a distal end of the shaft to engage one or more features of the implant, the sidewall of the engagement feature defining a distally facing recess and having an internally threaded surface configured to couple to a corresponding feature of the implant to couple the shaft to the implant. 15. The instrument of example 14, wherein the sidewall has an external threaded surface configured to couple to a corresponding feature on the implant to couple the shaft to the implant. 16. The device of example 15, wherein the internal threaded surface and the external threaded surface are located on both sides of the side wall. 17. The device of Example 16, wherein the internal threaded surface and the external threaded surface are axially offset such that the distal end of the external threaded surface is positioned proximal to the proximal end of the internal threaded surface. 18. The device of example 17, wherein the sidewall tapers distally starting distal to the outer threaded surface. 19. The device of any of Examples 14-18, wherein the sidewall begins proximal to the internal threaded surface and tapers distally. 20. The instrument described in any of Examples 14-19, wherein the engagement feature further comprises a centering pin extending distally from the engagement feature, the centering pin configured to be received within a portion of the implant. 21. A surgical method comprising: bringing a holder instrument into contact with the implant, the holder instrument having a longitudinal shaft including an engagement surface at a distal end thereof, the engagement surface having a reduced diameter portion with an internal thread; threading the holder instrument into a first corresponding feature of the implant, the first corresponding feature being a surface corresponding to the internal thread; and positioning the implant relative to the surgical site using a holder instrument. 22. The distal end of the holder device further comprises an external thread, and the method further comprises: Decoupling the holder device from the first corresponding feature; The method of Example 21, further comprising threading the holder instrument into a second corresponding feature of the implant, the second corresponding feature being a surface corresponding to the external thread. 23. The method of example 22, wherein the second corresponding feature comprises an internal thread formed within a recess in the implant. 24. The method of any of Examples 21-23, wherein threading the holder device into the first corresponding feature further comprises engaging the external threads of the set screw with the internal threads. 25. The method of example 24, wherein the centering pin of the engagement surface is advanced distally into the recess of the set screw. 26. A surgical method comprising: coupling an inserter instrument to an implant having opposing arms defining a recess such that the inserter instrument contacts only one of the opposing arms to maintain access to the recess; positioning the implant relative to the surgical site using an inserter instrument such that at least a portion of the fixation element is disposed within a recess of the implant; and inserting a set screw into the implant to capture the fixation element within the recess of the implant while maintaining the position of the implant using an inserter instrument. 27. The method of Example 26, further comprising tightening the set screw by rotating the set screw in a first direction relative to the implant while applying a counter torque force to the implant using the inserter instrument. 28. The method of any of Examples 26-27, further comprising detaching the inserter instrument from the implant.

[0078] [Embodiment] (1) A surgical instrument, a proximal handle; a distal inserter portion having an elongated body defining a hollow interior, the distal inserter portion having an opening for receiving a portion of the proximal handle therein; a locking portion configured to engage one side portion of the implant; a control shaft received within the hollow interior, the control shaft configured to translate distally to engage the implant engaged by the locking portion; a knob configured to engage a proximal end of the control shaft to translate the control shaft relative to the distal inserter portion and transition the locking portion from an unlocked configuration to a locked configuration to secure the locking portion to the implant. (2) The surgical instrument of embodiment 1, wherein the locking portion further comprises a retractable clasp that slides along the surface of the implant and engages with a groove formed within the implant during distal translation of the control shaft. (3) The surgical instrument of claim 2, wherein the locking configuration further comprises pulling the retractable clasp upwardly and inwardly to press a proximally facing bearing surface of the clasp against a distally facing bearing surface of the implant. (4) The surgical instrument of embodiment 1, wherein the locking portion further comprises one or more insertion tabs and a stop beam, the insertion tabs configured to engage and lock onto a surface of the implant, and the stop beams configured to abut the implant to prevent further translation of the control shaft. (5) The surgical instrument of claim 1, wherein the distal inserter portion includes one or more attachment features extending from the distal inserter portion, the attachment features configured to be received within an auxiliary instrument for coupling to the auxiliary instrument.

[0079] (6) The surgical instrument of claim 5, wherein the one or more attachment features further comprise one or more pins extending from the body of the distal inserter portion. (7) The surgical instrument of claim 5, further comprising a reducer instrument that engages with the one or more attachment features, the reducer instrument having a reducer shaft received within a housing for reducing a spinal rod into the implant. (8) The surgical instrument of claim 7, wherein the housing further comprises one or more arms extending from the housing, the arms having one or more tracks for receiving the one or more mounting features therein. (9) The surgical instrument of claim 7, wherein the reducer instrument further comprises a retaining lever coupled to the housing to facilitate locking the reducer instrument to the one or more attachment features. (10) The surgical instrument of claim 9, wherein the retention lever is configured to pivot relative to the housing to lock the reducer instrument to the distal inserter portion.

[0080] (11) The surgical instrument of claim 7, wherein the reducer shaft comprises a drive joint configured to couple to an adapter for moving the reducer shaft relative to the housing. (12) The surgical instrument of embodiment 7, wherein the reducer shaft includes a proximal threaded portion and a distal translation portion, and wherein rotation of the proximal threaded portion translates the distal portion into engagement with the spinal rod. (13) The surgical instrument of claim 12, wherein the instrument provides counter torque during spinal rod reduction. (14) A surgical instrument, a proximal handle; a longitudinal shaft coupled to the handle; an engagement feature disposed on a distal end of the shaft to engage one or more features of an implant, the sidewall of the engagement feature defining a distally facing recess and having an internally threaded surface configured to mate with a corresponding feature of the implant to couple the shaft to the implant. (15) The instrument of embodiment 14, wherein the sidewall has an externally threaded surface configured to couple to a corresponding feature of the implant to couple the shaft to the implant.

[0081] (16) The device of embodiment 15, wherein the internal threaded surface and the external threaded surface are located on opposite sides of the side wall. (17) The device of embodiment 16, wherein the internal threaded surface and the external threaded surface are axially offset such that a distal end of the external threaded surface is positioned proximal to a proximal end of the internal threaded surface. (18) The device of embodiment 17, wherein the sidewall tapers distally starting distal to the outer threaded surface. (19) The device of embodiment 14, wherein the sidewall begins proximal to the internal threaded surface and tapers distally. (20) The instrument of embodiment 14, wherein the engagement feature further comprises a centering pin extending distally from the engagement feature, the centering pin configured to be received within a portion of the implant.

Claims

1. A surgical instrument comprising: a proximal handle; a distal inserter portion having an elongated body defining a hollow interior, the distal inserter portion having an opening for receiving a portion of the proximal handle therein; a locking portion configured to engage one side portion of the implant; a control shaft received within the hollow interior, the control shaft configured to translate distally to engage the implant engaged by the locking portion; a knob configured to engage a proximal end of the control shaft to translate the control shaft relative to the distal inserter portion and transition the locking portion from an unlocked configuration to a locked configuration to secure the locking portion to the implant.

2. The surgical instrument of claim 1 , wherein the locking portion further comprises a retractable clasp that slides along a surface of the implant and engages a groove formed within the implant during distal translation of the control shaft.

3. 3. The surgical instrument of claim 2, wherein the locking configuration further comprises pulling the retractable clasp upwardly and inwardly to press a proximally facing bearing surface of the clasp against a distally facing bearing surface of the implant.

4. 10. The surgical instrument of claim 1, wherein the locking portion further comprises one or more insertion tabs and stop beams, the insertion tabs configured to engage and lock onto a surface of the implant and the stop beams configured to abut the implant to prevent further translation of the control shaft.

5. 10. The surgical instrument of claim 1, wherein the distal inserter portion includes one or more attachment features extending therefrom, the attachment features configured to be received within an auxiliary instrument for coupling to the auxiliary instrument.

6. The surgical instrument of claim 5, wherein the one or more attachment features further comprise one or more pins extending from the body of the distal inserter portion.

7. 6. The surgical instrument of claim 5, further comprising a reducer instrument that engages the one or more attachment features, the reducer instrument having a reducer shaft received within a housing for reducing a spinal rod into the implant.

8. The surgical instrument of claim 7, wherein the housing further comprises one or more arms extending therefrom, the arms having one or more tracks for receiving the one or more mounting features therein.

9. The surgical instrument of claim 7, wherein the reducer instrument further comprises a retention lever coupled to the housing to facilitate locking the reducer instrument to the one or more mounting features.

10. The surgical instrument of claim 9, wherein the retention lever is configured to pivot relative to the housing to lock the reducer instrument to the distal inserter portion.

11. The surgical instrument of claim 7, wherein the reducer shaft includes a drive joint configured to couple to an adapter for moving the reducer shaft relative to the housing.

12. The surgical instrument of claim 7, wherein the reducer shaft includes a proximal threaded portion and a distal translating portion, wherein rotation of the proximal threaded portion translates the distal portion into engagement with the spinal rod.

13. The surgical instrument of claim 12, wherein the instrument provides a counter torque during spinal rod reduction.

14. A surgical instrument comprising: a proximal handle; a longitudinal shaft coupled to the handle; an engagement feature disposed on a distal end of the shaft to engage one or more features of an implant, the engagement feature having a sidewall defining a distally facing recess and an internally threaded surface configured to mate with a corresponding feature of the implant to couple the shaft to the implant.

15. The instrument of claim 14 , wherein the sidewall has an externally threaded surface configured to mate with a corresponding feature on the implant to couple the shaft to the implant.

16. The device of claim 15, wherein the internal threaded surface and the external threaded surface are located on opposite sides of the sidewall.

17. 17. The instrument of claim 16, wherein the internal threaded surface and the external threaded surface are axially offset such that a distal end of the external threaded surface is positioned proximal to a proximal end of the internal threaded surface.

18. The instrument of claim 17, wherein the sidewall tapers distally beginning distal to the externally threaded surface.

19. The instrument of claim 14 , wherein the sidewall begins proximal to the internal threaded surface and tapers distally.

20. The instrument of claim 14 , wherein the engagement feature further comprises a centering pin extending distally from the engagement feature, the centering pin configured to be received within a portion of the implant.

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