Surgical implant instrument

By designing a surgical insertion device with a hollow interior and a knob locking handle, the problem of inserting and handling of surgical connector devices in the prior art in minimally invasive surgery is solved, and higher clamping force and counter torque are achieved, and positioning accuracy and fixing stability of the implant are improved.

CN119947667APending Publication Date: 2025-05-06MEDOS INT SARL
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Patent Information

Application Number
CN202380065258.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-09-13
Filing Date
2023-09-13
Publication Date
2025-05-06

AI Technical Summary

Technical Problem

Existing surgical connector devices are difficult to effectively insert and handle in minimally invasive surgery and procedures involving narrow anatomical areas, and lack the ability to provide sufficient clamping force and countertorque.

Method used

A surgical insertion instrument is designed with an elongated body and a knob locking handle that can define a hollow interior, capable of engagement with a single-sided portion of the implant, and locking and unlocking through a control shaft and knob, providing countertorque and auxiliary instrument coupling functions.

Benefits of technology

It improves the difficulty of manipulating and inserting the implant at the surgical site, provides sufficient clamping force and counter torque, and enhances the positioning accuracy and fixing stability of the implant.

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Abstract

A surgical instrument for interfacing with an implant may include an inserter configured to interface with a single-sided portion of the implant. The inserter may include a control shaft configured to lock or unlock the inserter coupled with the implant. Actuation of the control shaft may occur by a knob capable of controlling movement of the control shaft. The inserter may assist in positioning the implant relative to the surgical site and allow reaction torque to be applied when transmitting torque to tighten a set screw or the like. Additional instruments may also be used to manipulate the implant. For example, a supplemental instrument may be coupled to an inserter, such as a reduction instrument, to facilitate reduction of the shaft, etc. Alternatively or additionally, a gripping instrument may be used that has a distal threaded engagement feature for coupling to the implant to facilitate positioning of the implant.
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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 couple multiple fixation rods or other elements to facilitate various surgical procedures, including spinal surgery. Background Art

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

[0003] Conventional instruments and systems have several deficiencies in manipulating and handling surgical implants (including surgical connectors) at the surgical site, especially in minimally invasive surgery or surgery involving narrow anatomical restricted areas (such as the lumbar or thoracic spine). For example, many handling instruments have been developed for certain spinal fixation elements (such as implantable pedicle screws or rods), but by contrast, fewer handling or docking instruments have been developed for spinal fixation connectors that connect multiple spinal fixation rods or other elements. As a result, surgeons using connector implants often have to make do with instruments that are not designed for their needs.

[0004] In addition, existing implant handling tools, such as rod holders and pliers, and the user's fingers, may not provide enough clamping force to resist the multi-directional forces that the implant is subjected to when being manipulated at the surgical site, making the positioning of the implant difficult. In addition, the insertion instrument may have a larger volume and may limit the extent or manner in which the implant can be manipulated, hinder the insertion of rods or other components into the implant, or cause other challenges. In addition, such insertion instruments may lack several important capabilities, which include providing access to implants and / or other components after implantation, providing counter torque during assembly and final locking of the spinal fixation system, connecting with other instruments to perform various additional operations, etc.

[0005] Therefore, there is a need for improved surgical connector instruments to improve the insertion and handling of surgical connectors at a surgical site. Summary of the invention

[0006] Surgical instruments, systems and related methods of use are disclosed herein, and these surgical instruments, systems and related methods of use improve the insertion and processing of implants such as surgical connectors, bone screws or anchors during surgical procedures. A variety of such instruments are disclosed herein. In one embodiment, an insertion instrument can be provided, which is used to connect with the unilateral part of an implant such as a connector, a bone screw, etc., to promote the manipulation and insertion of the implant at the surgical site. The insertion instrument can use a knob or a locking handle to actuate a locking mechanism so that the insertion instrument is switched between an unlocking configuration and a locking configuration when it is together with the connector. In some embodiments, the insertion instrument can provide a counter torque during spinal rod reduction, set screw insertion, and various additional surgical procedures without the need to disengage the insertion instrument from the implant. The insertion instrument may also include one or more feature parts to promote the connection with an auxiliary instrument. For example, a reduction instrument may be attached to the insertion instrument to promote the reduction of a rod or other fixing elements into an implant. The reduction instrument may include a reducer shaft disposed in the housing so that rotation of the reducer shaft can cause the proximal end of the reducer shaft to spirally pass through the housing, thereby translating the distal portion into contact with a spinal rod disposed in the implant until the rod is properly reset or in place relative to the implant. In some embodiments, the holding instrument may be coupled to the implant to facilitate insertion and handling of the implant at the surgical site. The holding instrument may include one or more thread forms, including male and female threads, to provide a variety of options for coupling to surgical implants.

[0007] In one aspect, a surgical instrument is disclosed, which may include: a proximal handle and a distal inserter portion, the distal inserter portion having an elongated body that can define a hollow interior. The distal inserter portion may have an opening for receiving a portion of the proximal handle therein. The instrument may also include: a locking portion configured to engage a unilateral portion 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 may also include a knob configured to engage the proximal end of the control shaft so that the control shaft translates relative to the distal inserter portion, thereby converting 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 may be included and considered to be within the scope of the present disclosure. For example, in some embodiments, the locking portion may also include a retractable catch that can slide along the surface of the implant during distal translation of the control shaft to engage a groove formed in the implant.

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

[0010] In some embodiments, the locking portion may also include one or more insert tabs and a stop beam, wherein the insert tab may engage a surface of the implant to lock to the implant and the stop beam may be configured to abut the implant to prevent further translation of the control shaft.

[0011] In some embodiments, the distal inserter portion may include one or more attachment features extending therefrom, which may be configured to be received in an auxiliary device to couple with the auxiliary device. In some embodiments, the one or more attachment features may include one or more pins extending from the body of the distal inserter portion.

[0012] In some embodiments, the auxiliary instrument can be a reduction instrument, which can engage the one or more attachment features, and the reduction instrument can have a reducer shaft, which is received in the housing to reduce the spinal rod to the implant. In some embodiments, the housing of the reduction instrument may include one or more arms extending therefrom, and these arms may have one or more tracks, which are used to receive the one or more attachment features therein. In some embodiments, the reduction instrument may include a retaining lever, which is coupled to the housing so as to lock the reduction instrument to the one or more attachment features. In some embodiments, the retaining lever may be configured to pivot relative to the housing to lock the reduction instrument to the distal inserter portion. In some embodiments, the reducer shaft may include a drive interface, which is configured to be coupled 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, wherein the rotation of the proximal threaded portion may translate the distal portion into engagement with the spinal rod. Still further, in some embodiments, the instrument can provide counter-torque during spinal rod reduction.

[0013] In another aspect, a surgical instrument is disclosed that may include: a proximal handle; a longitudinal shaft coupled to the handle; and 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 may define a distally facing recess and may have an internally threaded surface configured to couple to a corresponding feature of the implant, thereby coupling the shaft to the implant.

[0014] Similar to the above-mentioned embodiments, the present disclosure may include any one of a variety of alternative or additional features, and it is considered to be within the scope of the present disclosure. For example, in some embodiments, the sidewall may have an external threaded surface, and the external threaded surface is configured to be coupled to the corresponding feature of the implant, thereby coupling the shaft to the implant. In some embodiments, the internal threaded surface and the external threaded surface may be located on the opposite surface of the sidewall. In some embodiments, the internal threaded surface and the external threaded surface may be offset in the axial direction so that the distal end of the external threaded surface is positioned near the proximal end of the internal threaded surface. In some embodiments, the sidewall may taper distally from the distal side of the external threaded surface.

[0015] In some embodiments, the sidewall can taper from proximal to distal of the internal threaded surface.

[0016] In some 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 in a portion of the implant.

[0017] In another aspect, a surgical method is disclosed that may include contacting a grasping instrument with an implant, the grasping instrument having a longitudinal axis, the longitudinal axis including an engagement surface on a distal end thereof, and the engagement surface may have a reduced diameter portion with an internal thread. The method may also include threading the grasping instrument into a first corresponding feature of the implant, the first corresponding feature may be a surface corresponding to the internal thread. The method may also include positioning the implant relative to a surgical site using the grasping instrument.

[0018] As with the above-described instruments, the methods disclosed herein may include any of a variety of additional or alternative steps that are considered to be within the scope of the present disclosure. For example, in some embodiments, the distal end of the holding instrument may include external threads, and the method may include: decoupling the holding instrument from the first corresponding feature; and threading the holding instrument into a second corresponding feature of the implant, the second corresponding feature being a surface corresponding to the external threads. In some embodiments, the second corresponding feature may include internal threads formed in a groove of the implant.

[0019] In some embodiments, threading the gripping instrument into the first corresponding feature may further include engaging an outer thread of a set screw with the inner thread. In some embodiments, the centering pin of the engagement surface may be advanced distally into a recess of the set screw.

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

[0021] Similar to the above-described embodiments, the present disclosure may include any of a variety of additional or alternative steps and are considered to be within the scope of the present disclosure. For example, in some embodiments, the method may include: tightening the set screw by rotating the set screw in a first direction relative to the implant while transmitting a counter torque force to the implant using the insertion instrument.

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

[0023] Additional details are provided below. Any of the features or variations described herein may be applied to any specific aspect or embodiment of the present disclosure in a variety of different combinations. No specific combination is explicitly described simply to avoid unnecessary space or redundancy. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Aspects and embodiments of the present disclosure will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

[0025] Figure 1A is a perspective view of one embodiment of an insertion instrument;

[0026] Figure 1B for Figure 1A An exploded view of the device;

[0027] Figure 1C for Figure 1A A lateral longitudinal cross-sectional view of the device;

[0028] Figure 2A is a front view of an embodiment of an implant that can be used with Figure 1A Use with other instruments;

[0029] Figure 2B for Figure 2A Perspective view of the mid-implant;

[0030] Figure 3 To connect to Figure 2A A perspective view of one embodiment of an insertion instrument for an implant in FIG.

[0031] Figure 4A for Figure 3 A detailed perspective view of the distal portion of the device;

[0032] Figure 4B for Figure 3 An alternative detailed perspective view of a distal portion of the device;

[0033] Figure 4C for Figure 3 A detailed perspective longitudinal cross-sectional view of the distal portion of the instrument;

[0034] Figure 5 for Figure 3 A detailed perspective longitudinal section view of the connection between the insertion instrument and the implant;

[0035] Fig. 6A is a top perspective view of one embodiment of an insertion instrument;

[0036] Figure 6B for Fig. 6A An exploded view of the device;

[0037] Figure 6C for Fig. 6A A lateral longitudinal section view of the device;

[0038] Figure 7 for Fig. 6A Insertion device connected to Figure 2A Perspective view of the mid-implant;

[0039] Fig. 8A is a perspective view of one embodiment of a reduction instrument that can be used as an auxiliary instrument for the insertion instrument of the present disclosure;

[0040] Figure 8B for Fig. 8A Exploded view of the reduction instrument;

[0041] Figure 8C for Fig. 8A A lateral longitudinal section view of the device;

[0042] Fig. 9 for Fig. 8A The reduction device is connected to Fig. 6A Side view of the instrument being inserted;

[0043] Fig.10 For driving the handle to be connected to Fig. 9 Side view of the middle component;

[0044] Fig.11 for Fig. 9 A detailed lateral longitudinal cross-sectional view of the middle assembly repositioning the fixation element into the implant recess;

[0045] Fig.12 is a perspective view of one embodiment of an insertion instrument;

[0046] Fig.13A is a perspective view of one embodiment of a holding instrument;

[0047] Fig. 13B for Fig.13A Exploded view of the medium grip instrument;

[0048] Fig.14 for Fig.13A A detailed perspective view of the distal portion of the mid-grip instrument;

[0049] Fig.15 for Fig.13A The holding instrument is connected to the inner thread of the engagement feature portion via the inner thread of the engagement feature portion. Figure 2A A side view of the middle connector connection;

[0050] Fig.16 for Fig.13A The middle holding instrument is connected to the outer thread of the engagement feature portion via the outer thread of the engagement feature portion. Figure 2A A side view of the middle connector connection;

[0051] Fig.17 is a side longitudinal cross-sectional view of one embodiment of an engagement feature of a gripping instrument having an axial offset between internal and external threads;

[0052] Fig.18 is a perspective view of one embodiment of a holding instrument;

[0053] Fig.19 for Fig.18 A detailed perspective view of the distal portion of the mid-grip instrument;

[0054] Fig. 20 for Fig.18 a side longitudinal cross-sectional view of an engagement feature of a mid-grip instrument;

[0055] Fig.21 is a perspective view of one embodiment of an insertion instrument;

[0056] Fig.22A for Fig.21 a detailed perspective view of a distal portion of the device; and

[0057] Fig. 22B for Fig.21 Detailed perspective longitudinal cross-sectional view of the distal portion of the instrument. DETAILED DESCRIPTION

[0058] Certain exemplary embodiments will now be described to understand the structure, function, manufacture and use principles of the devices, systems and methods disclosed herein as a whole. One or more examples of these embodiments are illustrated in the accompanying drawings. The devices, systems and methods specifically described herein and shown in the accompanying drawings are non-restrictive embodiments. The features shown or described in conjunction with one embodiment can be combined with the features of other embodiments. Such modifications and variations are intended to be included in the scope of the present disclosure. In addition, with respect to the use of linear dimensions, circular dimensions or other dimensions in the description of the disclosed devices and methods, such dimensions are not intended to limit the type of shape that can be used in combination with such devices and methods. The equivalent of such dimensions can be determined for different geometric shapes, etc. In addition, similarly numbered components of the embodiments may generally have similar features. Further, the size and shape of the device and its components may depend at least on the anatomical structure of the subject in which the devices will be used, the size and shape of the object in which the devices will be used, and the methods and procedures in which the devices will be used.

[0059] This article discloses a surgical instrument, system and related use method for docking with an implant during a surgical procedure. The surgical instrument may include an inserter having a handle at a proximal end and being configured to engage with a unilateral portion of an implant. The inserter may include a control shaft configured to move longitudinally to lock or unlock the connection with the implant. The actuation of the control shaft may occur through a knob that can control the movement of the control shaft. The inserter can help position the implant relative to the surgical site and allows counter torque to be applied when transmitting torque to tighten a set screw, etc. Additional instruments may also be used to manipulate the implant. For example, an auxiliary instrument may be coupled to the inserter, such as a reset instrument, to facilitate the reset of a rod, etc. Alternatively or additionally, a gripping instrument may be used, the gripping instrument having a distal threaded engagement feature portion, the distal threaded engagement feature portion being used to couple to the implant to facilitate insertion and / or manipulation of the implant during a surgical procedure.

[0060] Figures 1A to 1CA perspective view, an exploded view, and a longitudinal cross-sectional view of an embodiment of a surgical implant insertion instrument 100 are illustrated, respectively. The instrument 100 may include a proximal handle 102 and a distal inserter portion 104. The inserter portion 104 may 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, which are configured to engage a single-sided portion of an implant, for example, a surgical connector configured to couple multiple spinal fixation rods or other elements to each other, a polyaxial bone screw, other bone anchors, etc. The locking element 107 may be configured to engage a single-sided portion of an implant, such as a single side of a rod slot formed in a connector, as described in detail below, so that the locking element 107 cooperates with the connector to secure the insertion instrument to the implant, so as to facilitate insertion and manipulation of the implant. Although the present disclosure often refers to surgical connectors, the various instruments disclosed herein may also be used for other types of implants, including various screws, hooks, plates, nails, etc. In addition, although surgical connectors are mentioned herein for connecting multiple spinal fixation rods, such connectors are also used to connect different spinal fixation elements. For example, in some embodiments, one or two spinal fixation elements connected by the connector can be a flexible cable.

[0061] The inserter portion 104 may include a control shaft 108 having a distal shaft portion 122 that, together with the locking element 107, forms a snap on the distal end of the instrument. The control shaft 108 may be movably coupled to the distal inserter portion 104 by a pin 114 that passes through a hole 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 may include a proximal shaft portion 120 that is threadedly coupled to the distal shaft portion 122, for example, by using male threads 123 formed on the proximal end of the distal shaft portion 122 to interface with female threads (not shown) formed along the hole in the distal end of the proximal shaft portion 120. The proximal shaft portion 120 may be disposed through a hole formed in the proximal handle 102 and may include a threaded proximal portion 166 that may be coupled to the knob 118. The control shaft 108 can be configured to move longitudinally relative to the inserter portion 104 in response to the rotation of the knob 118 or other types of actuation control, so that the catch is locked or unlocked with the surgical implant, as described below. A proximal nut 170 or other stopper can be coupled to the threaded portion 166 to prevent the knob 118 from accidentally falling off the proximal shaft portion 120. In addition, a spring 172 or other biasing element can be configured to cause the control shaft 108 to move proximally relative to the inserter portion 104, thereby providing a temporary locking force for docking with the surgical implant, as described below. A guide 112 can be provided around the control shaft 108 between the spring 172 and the knob 118, and the guide is configured to translate without rotating, for example, sliding in the slot 117 formed in the inserter portion 104 via the wing. The guide can help ensure that the knob does not transmit any rotational force to the spring 172 and makes the instrument operation smoother.

[0062] The handle 102 may have a variety of forms to be suitable for docking directly with different users and / or docking with a surgical robot or other instrument (e.g., a manually adjustable clamp or fixture, etc.). The handle 102 may be modular so that different types of handles (e.g., a handle configured for human or machine docking) or handles of different sizes for different users may be used. Therefore, the handle 102 may include a base 124, which is configured to be coupled to the inserter portion 104, for example, by using a column that can be received in a hole formed in the inserter portion. The handle 102 may also include a gripping or docking portion 126 and a fixing portion 128, which can securely couple the gripping portion 126 to the base 124. In the illustrated embodiment, the fixing portion 128 extends through the hole formed in the gripping portion 126 and is threadedly coupled to a portion of the base 124, but there may be a variety of constructions.

[0063] FIG. 2A to FIG. 2BA surgical implant, namely a surgical connector 200, and an embodiment of a unilateral locking feature thereof are illustrated, which can be docked with a distal portion of an insertion instrument 100 to achieve selective connection between the implant and the insertion instrument. Although the illustrated connector 200 is a rod-to-rod connector for connecting multiple rods to each other, other types of surgical connectors can also be used, for example, by incorporating the following features to achieve connection with the insertion instrument 100. The implant 200 may include one or more open recesses 202 formed in its body (e.g., for receiving a rod and / or a set screw therethrough). For example, in some embodiments, such as FIG. 2A to FIG. 2B As illustrated, the body may include relative arms 201a, 201b, which define a groove 202 therebetween. The unilateral portion of the implant 200 may be a portion of the implant that faces one end of the implant or is located on one side of the open groove 202, such as arm 201a. For example, the unilateral portion 205 may correspond to an end portion of the implant 200 that is opposite to or located on one side of the open groove 202. By docking with one side of the open groove 202, the groove may continue to be accessed (e.g., not blocked) after the locking element 107 of the insertion instrument 100 is engaged in a locked configuration. This may enable, for example, a rod and / or a set screw 210 to be received in one or more grooves in the groove 202 while being coupled to the insertion instrument 100. Returning to the connector 200, the connector may include a pre-installed set screw 250 that may protrude proximally and expose a thread 252. In some embodiments, the set screw 250 may be pre-installed on the connector 200, but it should be understood that the set screw 250 may also be added to the connector at various stages during the surgical procedure. FIG. 13A to FIG. 20 The instrument in some embodiments can be used to manipulate the connector 200 by coupling to the threads 240 of the connector 200 or the threads 252 on the set screw 250 that protrude from the connector body.

[0064] The locking interface of connector 200 may include a top or proximally facing bearing surface 210 and a lateral groove 220. Each of these corresponding locking elements may be configured to contact, mate, interlock, or otherwise engage locking element 107, such as Figure 3 As shown, the connector 200 is restricted from moving relative to the insertion instrument 100. For example, FIG. 2A to FIG. 2B As shown, the top or proximal-facing bearing surface 210 can correspond to the top surface of the connector 200, which can partially surround the upper edge of the open groove 202. The pair of lateral grooves 220 can correspond to a pair of vertical grooves formed on the side wall of the connector adjacent to the open groove 202. The vertical grooves 220 can intersect the groove 202, such as FIG. 2A to FIG. 2BAs shown, it may also be spaced a certain distance from the groove 202. It may also include a distally facing load-bearing surface (not shown), for example, a locking protrusion formed on the surface of the implant and extending laterally between the pair of vertical grooves 220. In some embodiments, the connector 200 may also include a horizontal groove or cutout 232 formed below the top or proximally facing load-bearing surface 210 along the proximal end of the single-sided portion. Figure 2A and Figure 2B Further details of connectors of the type shown and unilateral instruments 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.

[0065] Figures 3 to 5 The insertion instrument 3000 coupled to the connector 200 is illustrated in more detail. The insertion instrument 3000 may be similar to the insertion instrument 100 in many respects. In the illustrated embodiment, for example, only the form of the handle 3002 is different from the inserter 100. Therefore, a detailed description of the inserter 3000 is omitted, and reference may be made to the features associated with the inserter 100. Although, as described above, the insertion instrument 3000 may be coupled to a polyaxial screw head or other implant, the insertion instrument 3000 is discussed below with respect to the connector 200. Figures 3 to 5 As shown, the instrument 3000 can be coupled to the single-sided portion 205 so that the locking element 107 engages the single-sided portion 205, thereby fixing the connector 200 in place. FIG. 4A to FIG. 4C In more detail, the inserter portion 104 may include a groove 144 that terminates in or includes a locking element 107 to couple or uncouple with the connector 200. The elongated body 106 of the inserter portion 104 may terminate in a forked instrument tip 146 that includes a pair of parallel arms 148a, 148b (collectively referred to as 148). The spacing and size of the arms 148 may be configured to form an implant receiving slot pocket 150 between the opposing faces of the arms 148. The slot pocket 150 may be configured to accommodate the width and depth of the unilateral portion 205 of the connector 200.

[0066] The distal portion of the elongated body 106 of the inserter portion 104 may include a horizontal stop beam 154 extending transversely between the opposing faces of the arm portion 148. The height of the stop beam 154 relative to the distal end of the arm portion 148 may be configured to match or at least partially match the height of the single-sided portion 205 of the connector. The stop beam 154 may have a distally facing bearing surface 156 that is configured to contact the top or proximal bearing surface 210 of the connector, thereby limiting longitudinal movement of the connector in the proximal direction (e.g., upward movement). The shape of the stop beam 154 may match the shape of the top bearing surface 210 of the connector. For example, where the top bearing surface 210 of the connector forms the outer edge of an open recess 202 for receiving a rod and / or a set screw, the forward and distal sides of the stop beam 154 may be shaped so that the stop beam 154 does not block or otherwise interfere with the open recess 202 of the connector.

[0067] The forked instrument tip 146 may include a pair of opposing insertion tabs 160a, 160b (collectively 160) projecting longitudinally along opposing faces of the arm portion 148 at or adjacent the front of the pocket 150. The insertion tabs 160 may have lateral bearing surfaces configured to mate with and slide along lateral corresponding slots 220 formed in a single-sided portion of the connector to limit lateral movement (e.g., side-to-side and front-to-back movement) of the implant.

[0068] The locking element 107 may include a retractable hook 162 formed along a distal portion of the control shaft 108 and disposed between opposing faces of the arm 148 at or adjacent the rear of the slot pocket 150. The hook 162 may be configured to engage a slot 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 it moves from an unlocked configuration to a locked configuration, where the hook 162 is disposed within the slot 232 of the connector 200. The retractable catch 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 it moves from a locked configuration to an unlocked configuration, where the connector may be detached from the instrument. The movement of the hook 162 relative to the elongated body 106 of the inserter portion 104 can be controlled by the shape of the track 116, which receives the pin 114 that is disposed through a hole in the distal portion of the control shaft 108 including the hook 162. For example, by forming the track 116 in a ramped or angled manner relative to the longitudinal axis of the inserter portion 104, the distal portion of the control shaft 108 including the hook 162 can be moved in the second direction as it translates distally and proximally relative to the inserter portion.

[0069] Figure 5The locking of the retractable hook 162 with the connector 200 is shown in more detail. To secure the connector 200 to the instrument 100, the retractable hook 162 may first be positioned over the proximal end of the connector 200 or other implant so that the receiving pocket 150 is aligned with the single-sided portion 205 of the connector. As the insertion instrument 100 is advanced distally toward the connector 200, the insertion tab 160 of the arm 148 may slide longitudinally along the lateral slot 220 of the locking interface, thereby guiding the single-sided portion 205 of the connector 200 proximally into the pocket 150.

[0070] Translation of the control shaft 108 and the hook 162 formed thereon can be controlled by rotating the knob 118 and / or manually manipulating the control shaft against the biasing force of the spring 172. For example, after assembly, the spring 172 can transmit a proximally directed biasing force to the control shaft 108, and thus to the knob 118, through its compression between the elongated body 106 of the inserter portion 104 and the guide 112. This can provide a temporary locking force to the instrument 100, such that the control shaft 108 and hook 162 must be advanced distally against the biasing force of the spring in order to couple with the connector 200, and will tend to couple with any properly positioned connector without further user interaction once the biasing force is restored.

[0071] Thus, in one embodiment, coupling a connector or other implant to the insertion instrument 100 may include a user advancing the control shaft 108 distally to resist the biasing force of the spring 172, for example, by manually pushing the knob 118 to advance the knob distally, and the control shaft 108 is threadedly coupled to the knob. The connector 200 or other implant may then be positioned relative to the distal end of the insertion instrument 100 so that the forked distal tip engages the side groove of the unilateral portion 205 of the connector 200 or other implant. The user may then release the force used to overcome the biasing force of the spring 172. The spring 172 may then cause the control shaft 108 to move proximally relative to the inserter portion 104, which may drive the hook 162 to move proximally to engage the groove 232 formed in the unilateral portion 205 of the connector or other implant.

[0072] To securely couple the connector 200 to the insertion instrument 100 beyond the temporary 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 ensures that the control shaft 108 cannot move distally relative to the inserter portion 104, thereby locking the instrument 100 and preventing it from being decoupled from the connector 200.

[0073] Releasing the connector 200 or other implant from the instrument 100 may include rotating the knob 118 in the reverse direction to introduce clearance between the distal end of the knob 118 and the proximal surface of the inserter portion 104. This will return the instrument to a temporary locked state with the connector or other implant. To completely disengage the connector, the user may again overcome the biasing force of the spring 172 and push the knob 118 and control shaft 108 distally to disengage the hook 162 from the slot 232 of the connector 200, thereby allowing the connector to be separated from the insertion instrument 100.

[0074] like Figure 5 As shown, during the connection process, the connector 200 can be proximally advanced relative to the elongated body 106 of the inserter portion 104 until the distally facing bearing surface 156 of the stop beam 154 contacts or abuts the top or proximal bearing surface 210 of the connector locking interface. Once the connector top bearing surface 210 contacts or abuts the stop beam 154, the retractable hook 162 can be engaged to lock the connector in place. To this end, the control shaft 108 can be retracted proximally (e.g., via the biasing force from the spring 172 and / or via the actuation from the knob 118). As the control shaft translates proximally relative to the inserter portion 104, the pin 114 can slide in the slot 116 of the elongated body 106 of the inserter portion 104 to control the retractable hook 162 to move from the unlocked configuration to the locked configuration relative to the connector. The pin 114 can be configured to protrude from at least one of the laterally opposed faces of the control shaft 108 and enter a slot 116 formed in a distal portion of the elongated body 106 of the inserter portion 104. As described above, the slot 116 can include a ramp portion that extends obliquely relative to the longitudinal axis of the instrument. Thus, movement of the pin 114 along the slot 116 can enable movement of the hook 162 along the longitudinal axis of the instrument and transversely to the longitudinal axis (e.g., inward or outward, toward or away from the central axis of the connector).

[0075] In order to lock the insertion instrument 100 to the connector 200 or other implant, the retractable hook 162 can be pulled upward (i.e., in the proximal direction along the longitudinal axis of the instrument 100) and moved inward (i.e., transverse to the longitudinal axis of the instrument 100 and toward the longitudinal axis of the connector 200) toward the locking configuration, thereby forcing the hook 162 to engage with the groove 232 formed in the connector 200. In this locked configuration, the connector 200 can be captured and restricted in all directions of movement, thereby firmly coupling the connector 200 to the insertion instrument 100, so that the instrument can be used to remotely manipulate the position of the connector (i.e., the user holding the proximal end of the instrument 100 can control the position of the connector 200 coupled to the distal end of the instrument). The insertion instrument 100 can leave the groove 202 of the connector 200 unobstructed so that a spinal rod, a set screw, a rope or other fixation element, etc. can be set therein. In some embodiments, the insertion instrument 100 can be configured to provide a counter torque when the set screw 250 is inserted and tightened into the groove 202 of the connector 200. For example, when the user tightens the set screw by rotating in a first direction (e.g., via a driver, etc.), the user can simultaneously apply a counter-torque (e.g., a force in a second direction opposite to the first direction) through the insertion instrument 100 to resist the rotation or other movement of the connector 200 or other implants. The rigid connection between the insertion instrument 100 and the connector 200 limits relative movement in all directions, allowing the user to apply an effective counter-torque to the connector 200 via the insertion instrument 100. After the user completes the manipulation of the connector 200 using the instrument 100 (including using any secondary or auxiliary instrument as described herein), the insertion instrument 100 can be separated from the connector 200 by using the knob 118 to push the retractable hook 162 distally and / or manually push the control shaft 108 to move toward the unlocked configuration against the biasing force of the spring 172.

[0076] FIG. 6A to FIG. 6C and Figure 7 Another embodiment of a unilateral insertion instrument 100' is illustrated. As previously mentioned, the instrument 100' may be similar to the insertion instrument 100 in many respects, and therefore, for the sake of brevity, a detailed description of each feature is omitted. In the insertion instrument 100', a combination of a locking handle 118' replacing the knob 118 and a release button 119' is provided to actuate the insertion instrument 100'. The locking handle 118' may be received in a groove of the handle 102'. The locking handle 118' may include a body 120' having an extension 124' configured to be received in a hollow interior 121 of the insertion instrument 100'. The extension 124' may include a plurality of holes 126' therein, which may receive one or more pins 129 to pivotally couple the extension 124' to the inserter portion 104' and the control shaft 108, so that the relative movement between these components can be controlled.

[0077] like Figure 6C As shown in the longitudinal cross-sectional view of , the locking handle 118' can be pivotally coupled to the inserter portion 104 by a pin 129 and can also be pivotally coupled to the control shaft 108, so that actuating the locking handle (e.g., by squeezing the locking handle into the handle 102') pulls the control shaft 108 proximally, which can securely couple the connector 200 to the instrument 100'. A spring 181, such as a leaf spring, can transmit a biasing force to maintain the locking handle 118' in an extended state in which the instrument 100' is in an unlocked configuration and ready to receive the connector 200. The locking handle 118' can include a ratchet 182 formed on its inner surface, which can interface with a detent 183 as part of the release button 119'. Release button 119' is biased to maintain pawl 183 connected to ratchet 182 until a user presses release button 119' to overcome the bias of spring 134' and move pawl 183 away from ratchet 182. This also allows spring 181 to return locking handle 118' to its unlocked configuration.

[0078] The inserter portion 104 may include one or more attachment features extending therefrom for coupling the instrument 100 to one or more auxiliary instruments. Figure 7 As shown, the attachment features may include pins 180 extending from the body 106 that are configured to couple to an auxiliary instrument. FIG. 8A to FIG. 8C One embodiment of a reduction instrument 300 that can be used with the insertion instrument of the present disclosure is illustrated. As shown, the reduction instrument 300 can include a reducer shaft 301 disposed within a housing 303 that is configured to be coupled to the insertion instrument 100, as described in detail below.

[0079] The reducer shaft 301 may include a generally cylindrical shaft having a proximal end 301p and a distal end 301d, wherein an inner cavity or working channel 302 passes therethrough. The reducer shaft 301 may 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 may be rotated relative to the housing 303 about the axis A1 to advance the reducer shaft 302 distally relative to the instrument body and the connector 200 fixed thereto, thereby urging the rod to move toward the rod seat of the connector 200. The reducer shaft 301 may 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 may be a position in which the opposing arms 307a, 307b of the distal portion 306 are aligned with the rod so as to reduce the rod into the connector 200. As described above, the reducer shaft 301 can be hollow or can define a working channel therethrough, for example, to allow the reducer shaft 301 to be inserted over a guidewire, or to allow an instrument, implant, or other object to be inserted through the reducer shaft. For example, the 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 the lumen 302 to apply the set screw or closure mechanism to the connector.

[0080] The proximal portion 304 may include a drive interface 308 to facilitate application of 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 interface 308 may have any geometry that facilitates application of torque or other force to the reducer shaft 302, such as the hexagonal drive 310 shown. The drive interface 308 is received in the instrument or otherwise coupled to the instrument to transmit a drive force to the proximal portion 304.

[0081] The proximal portion 304 may include a flange or shoulder 314 to limit the extent to which the proximal portion 304 can be received in the corresponding drive interface of the instrument, as further described below. The proximal portion 304 may include an external thread 316 configured to cooperate with the thread 309 of the housing 303. The proximal portion 304 may include a coupling 318 for attaching the proximal portion 304 to the distal portion 306. The coupling 318 may be configured to attach the proximal portion 304 and the distal portion 306 to prevent relative longitudinal translation therebetween while still allowing the proximal portion 304 to rotate freely around the axis A1 relative to the distal portion 306. As shown, the coupling 318 may include a plurality of pins 322 received in an opening 324 of the proximal portion and extending into a circumferential groove 325 formed in the distal portion to limit relative translation of the proximal portion and the distal portion 304, 306 while allowing relative rotation.

[0082] A second coupling 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 in openings 382 formed in the housing 303 and extend into corresponding longitudinal slots 383 formed in the distal portion 306 to approximately limit relative rotation of the body 303 and the distal portion 306 while allowing relative translation.

[0083] As described above, the distal portion 306 may include one or more arms 307a, 307b (collectively referred to as 307) extending distally therefrom. The arm 307 may be configured to contact and bear against the spinal rod when the reducer shaft 301 is translated distally in the housing 303 to promote distal movement of the rod. The distal contact surface of the arm 307 may be shaped to match the rod used with the reducer shaft 301. For example, the arm 307 may include a circular cutout having a diameter commensurate with the rod diameter. Although two arms 307a, 307b are shown, the reducer shaft 302 may include any number of rod engagement arms.

[0084] As mentioned above, and as Figure 8C As shown, the outer housing 303 may include threads 309 that are configured to interface with threads 316 to control the movement of the reducer shaft 302 through the housing 303. The housing 303 may include one or more sets of arms extending therefrom for coupling the reduction instrument 300 with the insertion instrument 100. For example, as shown, the housing 3003 may include a first set of arms 326a, 326b (collectively 326) at the proximal end 303p of the housing and a second set of arms 328a, 328b (collectively 328) at the distal end 303d of the housing 303, which are configured to engage with the insertion instrument 100 therebetween. Each pair of arms 326, 328 may define a recess 330 that is configured to receive a portion of the insertion instrument 100' therein. The inner surface of the arms 326, 328 may include a recessed track 332 to receive one of the pins 180 extending from the elongated body 106 of the insertion instrument 100'. The recessed track 332 may be formed in the arms 326, 328 so that the pin 180 enters and slides in a direction toward the housing 303, thereby positioning the reduction instrument 300 relative to the insertion instrument 100.

[0085] The retaining lever 336 can be coupled to the housing 303 to switch the reduction instrument 300 between an unlocked configuration and a locked configuration. For example, the retaining lever 336 can be pivoted relative to the housing 303 to lock the pin 180 into the recessed track 332, thereby locking the reduction instrument 300 into the insertion instrument 100' in the locked configuration; and release the pin 180 from the recessed track 332 to unlock the reduction instrument 300 from the insertion instrument 100. The retaining lever 336 may include a body 338 that is configured to be disposed around the housing 303. The retaining lever 336 can be coupled to the housing 330 by a pair of pins 340 that are received in corresponding openings 342 of the arms 326, 328. A biasing element, such as a spring 344, can be disposed between the retaining lever 336 and the arms 326, 328 to apply a biasing force to the retaining lever 336. This biasing force can maintain the lever 336 in a locked configuration, thereby blocking the entrance to the track 332. In this way, the user must actuate the lever 336 to clear the opening of the track 332 and connect the housing 303 to the insertion instrument 100. This is different from the lower arm 326, in which the track 332 is always open. This facilitates the user to connect in the following order: slide the lower pin of the insertion instrument 100' into the track 332 of the lower arm 326, and then pivot the reset instrument 300 so that the upper arm 328 moves toward the insertion instrument and its upper pin. Next, the user actuates the lever 336 to slide the upper pin into the track 332 of the upper arm 328. Releasing the lever 336 when the pin is set in the track 332 can prevent the pin from coming out of the track 332, thereby maintaining the position of the reset instrument 300 relative to the insertion instrument 100'.

[0086] Figures 9 to 11 One embodiment of the connection between the insertion instrument 100' and the reduction instrument 300 is illustrated. As shown, the arms 326, 328 extending from the housing 303 of the reduction instrument 300 can receive the distal inserter portion 104 of the insertion instrument therebetween. The pin 180 can facilitate connection with the reduction instrument 300 by sliding in the recessed track 332 of the arms 326, 328 until the connection is completed, as described above.

[0087] Once coupled, one or more instruments may be used with the reducer shaft 301 to reduce the spinal rod into the connector. Fig.10 and Fig.11As shown, a reduction instrument 300 can be used to reduce the spinal rod 350 into the connector 200' (a different type of connector is shown, which has a single open groove to receive the rod and a second rod component extending laterally therefrom, but as described above, any type of connector or other implant can be used with the devices, systems and methods described herein). A drive handle 400 (or other driver, such as an electric driver, etc.) coupled to the drive interface 308 can be used to perform the reduction to reduce the spinal rod 350, while the insertion instrument 100' is connected to the connector 200' to provide counter torque when needed. During the reduction process, the drive handle 400 can be rotated relative to the housing 303 to advance the reducer shaft 302 distally, thereby advancing the distal portion 306 to contact the spinal rod 350 and cause the rod 350 to move into the groove of the connector 200'.

[0088] Figure 1 to Figure 5 The instrument 100, 3000 shown in FIG. 1 does not show a pin 180 for coupling to a secondary instrument, such as the reduction instrument 300. However, such a feature can certainly be incorporated into the insertion instrument 100, 3000 as previously described. Fig.12 An embodiment of an insertion instrument 100" is illustrated, which is similar to the insertion instrument of FIGS. Figure 5 The insertion instrument 100" is similar to the insertion instrument in (e.g., using a rotary knob actuator rather than a trigger actuator), but includes a pin 180 for connecting to a secondary or auxiliary instrument such as a reducer 300. The insertion 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 only partially therethrough, such that the path of the track 116" can be seen from a side view of the instrument. This can be achieved for a variety of reasons, including allowing a deeper track that can accommodate longer pins for greater strength, simplifying the manufacturing process (e.g., milling the track through the thickness of the distal portion of the instrument, rather than forming a blind track on its inward surface), etc.

[0089] FIG. 13A to FIG. 13BOne embodiment of a holding instrument 500 of the present disclosure is illustrated. The holding instrument 500 can be coupled to a connector 200 or other implant so that it can be introduced into a surgical site and attached to various types of hardware. The holding instrument 500 may include a distal engagement feature or surface 502 for coupling to the connector 200 to facilitate controlled insertion and / or manipulation of the connector 200 during a surgical procedure. The holding instrument 500 may include a longitudinal shaft 504 coupled to a proximal handle 506. The engagement feature 502 may be provided on a distal end 504d for coupling one or more connectors 200 to the handle 506. The engagement feature 502 may include a center pin 508 configured to be received in the connector 200. The proximal end 504p of the longitudinal shaft 504 may include a threaded surface 510 for engaging corresponding threads formed on an inner surface of the proximal handle 506, thereby coupling the longitudinal shaft to the proximal handle.

[0090] Fig.14 The engagement feature 502 is illustrated in greater detail. As shown, the engagement feature 502 can include male and female threads for coupling the holding instrument 500 to male and female interfaces of the connector 200, although external threads may not be present in some embodiments, as described below. For example, the engagement surface 502 can include a reduced diameter portion 507 defining an opening 512 and an associated recess 514 at a distal end of the longitudinal shaft 504 for receiving a centering pin 508 therein. The centering pin 508 can resemble a generally cylindrical post that extends into a recess of the connector 200, for example, Figure 2B The set screw drive feature groove 254 is shown. As shown, the opening 512 can surround the centering pin 508, thereby forming an annular groove 514 around the pin 508, which can receive a portion of the connector.

[0091] The reduced diameter portion 507 may include one or more threaded surfaces for threading the engagement surface into or threadingly engaging with the connector 200. In some embodiments, such as Fig.14 In the embodiment illustrated in FIG. 5 , multiple threaded surfaces may form a combination thread that allows the gripping instrument 500 to be used with the connector in a variety of ways. As shown, the engagement surface 502 may include an internal thread 516 and an external thread 518 disposed on the reduced diameter portion 507. The internal thread 516, or female thread, may extend along the inner surface of the reduced diameter portion 507 and may be used to couple with the threads of the set screw 250 of the connector 200, which protrude from the proximal surface of the connector. For example, as Fig.15 As shown, the engagement surface 502 can be formed by inserting a centering pin 508 into the fixing screw 250 (not shown, see FIG. 2A to FIG. 2B ) and engage the fixing screw 250 of the connector 200, wherein the internal thread 516 engages the external thread 252 of the fixing screw 250 to screw the holding instrument 250 onto the fixing screw. In this configuration, the centering pin 508 can be received in the opening 254 of the fixing screw 250, and the fixing screw 250 is disposed in the annular groove 514 between the centering pin 508 and the internal thread 516. The arrangement of the centering pin and the threaded connection of the holding instrument 500 and the fixing screw 250 can promote a rigid connection between the holding instrument 500 and the connector 200, thereby allowing a user to remotely manipulate the connector 200 through the holding instrument 500. In addition, there may be a mismatch between the amount of force required to rotate the fixing screw 250 relative to the connector 200 and the amount of force required to rotate the holding instrument 500 relative to the fixing screw 250, so that when the holding instrument 500 is connected or disconnected from the connector 200 via the fixing screw 250, the user will not inadvertently rotate the fixing screw 250 relative to the connector 200.

[0092] External threads 518, or male threads, may be threaded into internal threads 240 of connector 200. Fig.16 As shown, the external threads 518 can be threaded into corresponding internal threads 240 of the connector 200 or other implant, thereby coupling the grasping instrument 500 to the connector or other implant.

[0093] Fig.17 An alternative embodiment of the engagement surface 502 of the gripping instrument 500 is illustrated wherein the positions of the internal threads 516 and the external threads 518 are axially offset to increase the wall thickness of the instrument along its distal portion. Fig.17 As shown, the reduced diameter portion 507 of the gripping instrument 500 can extend beyond the distal end of the external threads 518 to form an extension 520 having a smooth outer wall. The internal threads 516 can be formed in the extension 520 so that the internal threads 516 terminate proximally at a position axially aligned with or distal to the distal-most external threads 518 (i.e., when mapped along the longitudinal axis of the instrument 500, the proximal internal threads 516 are positioned at the same point or distal to the distal-most external threads 518). This ensures that there is no position along the length of the reduced diameter portion 507 where the internal threads 516 are axially aligned with the external threads 518 (i.e., they overlap each other when mapped along the longitudinal axis of the instrument 500). This design is ideal because positioning the internal and external threads to be axially aligned with each other (i.e., they overlap each other when mapped along the longitudinal axis of the instrument 500) may reduce the thickness of the material forming the reduced diameter portion, thereby increasing the likelihood of fracture under load. Axially offsetting the internal threaded portion 516 and the external threaded portion 518 may allow for a thicker wall thickness of material to be used throughout the reduced diameter portion 507 .

[0094] Fig.17 Also shown is a smaller threaded hole 522 for coupling the centering pin 508 to the reduced diameter portion 507. For example, the centering pin 508 may include threads 524 (e.g., Fig. 13B As shown), these threads can be received in the threaded holes 522.

[0095] In some embodiments, the outer wall of the extension 520 may have a tapered shape, the diameter of which gradually decreases toward the distal end of the extension. This shape allows the extension 520 to extend deeper into the groove 202 of the connector or other implant when the gripping instrument 500 is connected to the connector or other implant (for example, by engaging the external threads 518 with the internal threads 240 of the connector 200). This taper prevents interference with the gripping instrument when it is advanced into the groove, and in some embodiments, the tapered outer surface of the extension 520 can abut the corresponding tapered inner surface of the connector groove 202, thereby enhancing the connection between the components.

[0096] Fig.18 Another embodiment of a holding instrument 500' of the present disclosure is illustrated. The holding instrument 500' can be coupled to a connector 200 or other implant so as to introduce the connector or other implant into a surgical site and couple it to other components or anatomical structures, etc. The holding instrument 500' may include a distal engagement feature or surface 502' for coupling to a connector 200 or other implant to facilitate controlled insertion and / or manipulation of the implant during a surgical procedure. The holding instrument 500' may include a longitudinal axis 504' coupled to a proximal handle 506'. The engagement feature 502' may be provided on a distal end 504d' for coupling one or more connectors 200 to the handle 506'. The engagement feature 502' may include a centering pin 508' configured to be received in 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', thereby coupling the longitudinal shaft to the proximal handle. In many aspects, the holding instrument 500' can be similar to the holding instrument 500 described above, and a detailed description is omitted here to avoid repetition.

[0097] Fig.19The engagement feature 502 is illustrated in greater detail. As shown, the engagement feature 502' may include threads for coupling the grasping instrument 500' to a threaded interface of the connector 200 or other implant. For example, the engagement surface 502' may include a reduced diameter portion 507' that defines an opening 512' at the distal end of the longitudinal shaft 504' for receiving a centering pin 508' therein. The centering pin 508' may resemble a generally cylindrical post that extends into a recess of the connector 200, for example, Figure 2B The set screw drive feature recess 254 is shown. As shown, the opening 512' can surround the centering pin 508', thereby forming an annular recess 514' around the pin 508', which can receive a portion of the connector.

[0098] The reduced diameter portion 507' may include a threaded surface for coupling the engagement surface to the connector 200 or other implant. As shown, the engagement surface 502' may include internal threads 516', which are provided on the reduced diameter portion 507'. As shown, the centering pin 508' can be advanced into a groove formed in the connector 200 or other implant, and the internal threads 516' can be docked with external threads of the connector or another intermediate component. For example, the internal threads 516' can extend along the inner surface of the reduced diameter portion 507' and can be used to couple with threads of, for example, the fixing screw 250 of the connector 200, which protrude from the proximal surface of the connector. For example, the engagement feature 502' can be inserted by inserting the centering pin 508' into the fixing screw 250 (see FIG. 2A to FIG. 2B ) and engage the fixing screw 250 of the connector 200, wherein the internal thread 516' engages the external thread 252 of the fixing screw 250 to screw the holding instrument 250 onto the fixing screw. In this configuration, the centering pin 508' can be received in the opening 254 of the fixing screw 250, and the fixing screw 250 is disposed in the annular groove 514 between the centering pin 508 and the internal thread 516'. The arrangement of the centering pin and the threaded connection of the holding instrument 500' and the fixing screw 250 can promote a rigid connection between the holding instrument 500' and the connector 200, thereby allowing a user to remotely manipulate the connector 200 through the holding instrument 500'. In addition, there may be a mismatch between the amount of force required to rotate the fixing screw 250 relative to the connector 200 and the amount of force required to rotate the holding instrument 500' relative to the fixing screw 250, so that when the holding instrument 500' is connected or disconnected from the connector 200 via the fixing screw 250, the user will not inadvertently rotate the fixing screw 250 relative to the connector 200.

[0099] Fig. 20The connection of the centering pin 508' to the holding instrument 500' is illustrated. As shown, the reduced diameter portion 507' of the holding instrument 500' can form an extension 520' having a smooth outer wall. The internal thread 516' can be formed on the inner surface of the extension 520', but does not extend to the outer wall. Using only the internal thread 516' can maximize the thickness of the material forming the reduced diameter portion, while also tapering distally along the outer diameter of the extension 520'. That is, the diameter D' of the internal thread 516' can be smaller than the outer diameter D1' of the reduced diameter portion 507'. In addition, the outer diameter D1' can decrease from the proximal end of the extension 520' to its distal end. Fig. 20 Also shown is a smaller threaded hole 522' for coupling the centering pin 508' to the instrument 500'. For example, the centering pin 508' may include threads 524' formed on its proximal end, which may be received in the threaded hole 522.

[0100] Fig.21 Another embodiment of an insertion instrument 100'' is illustrated. The insertion instrument 100'' can be similar to the insertion instruments 100, 300 in many respects, and therefore, a detailed description of each feature is omitted for brevity. For example, the insertion instrument 100'' can be coupled to a unilateral portion 205 of a connector 200 or other implant such that a locking element 107'' engages the unilateral portion 205, thereby securing the connector 200 or other implant in place. The distal portion of the insertion instrument 100'' coupled to the connector 200 is FIG. 22A to FIG. 22B As shown in detail in . As described above, the inserter portion 104' may include a groove 144'' that terminates in or includes a locking element 107'' to connect or disconnect with the connector 200''. The slender body 106'' of the inserter portion 104 may terminate in a forked instrument tip 146'' that includes a pair of parallel arms 148a'', 148b'' (collectively referred to as 148''). The spacing and size of the arms 148'' may be configured to form an implant receiving slot pocket 150'' between the opposing surfaces of the arms 148''. The slot pocket 150'' may be configured to accommodate the width and depth of the single-sided portion 205 of the connector 200 or other implant.

[0101] The locking element 107'" may include a retractable hook or catch 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 slot pocket 150'"'. The hook 162'" may be configured to engage a slot or notch 232 formed on the connector 200. The retractable hook 162'" may be configured to move proximally and laterally toward the connector (e.g., upward and inward) relative to the inserter portion 104'" when it moves from an unlocked configuration to a locked configuration, at which point the hook 162'" is disposed within the slot 232 of the connector 200. The retractable hook 162'" may be configured to move distally and laterally away from the connector (e.g., downward and outward) relative to the inserter portion 104 when it moves from a locked configuration to an unlocked configuration, at which point the connector may be detached from the instrument.

[0102] Recess 144'" can be wider than recess 144 to provide a more stable guiding surface for locking element 107'" entering inserter portion 104'"'. Additionally, locking element 107'" can also be wider than locking element 107 (e.g., extending further from the side of elongated body 106'"') to enhance the stability of insertion instrument 100'"'. For example, after insertion instrument 100'"' is locked to an implant (e.g., unilateral portion 250 of connector 200), a distal portion of inserter portion 104'"' can be subjected to various forces during controlled insertion, manipulation, and / or counter-torque 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 unnecessary movement, deflection, etc. In some embodiments, the transition between sizes of the connector capture opening can be gradual or smooth to prevent the connector from becoming blocked when encountering more abrupt transitions (e.g., steps or small diameter curved transitions).

[0103] The elongated body 106"' may include a track 116"' that extends through the entire thickness of the distal portion of the inserter portion 104"' so that the path of the track 116"' can be seen from a side view of the instrument. Fig.12 As described above with respect to inserter 100", this track configuration can be used to maximize the length of the pin or protrusion formed on the control shaft 108"' that slides within the track, thereby simplifying the manufacturing process, etc. In addition, as also described above with respect to track 116, track 116"' can be sloped or angled relative to the longitudinal axis of the inserter portion 104"', thereby allowing the distal portion of the control shaft 108"' including the hook 162"' to move in a second direction as it translates distally and proximally relative to the inserter portion.

[0104] The various devices and methods disclosed herein can be used in minimally invasive surgery and / or open surgery. Although the various devices and methods disclosed herein are generally described in the context of surgery on human patients, the methods and devices disclosed herein can be used in any of a variety of surgical procedures on any human or animal subject, or in non-surgical procedures.

[0105] The various devices disclosed herein can 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), and the like. In addition, various manufacturing methods can be utilized, including 3D printing or other additive manufacturing techniques, as well as more conventional manufacturing techniques, including molding, stamping, casting, machining, and the like.

[0106] The various devices or components disclosed herein may be designed to be discarded after a single use, or they may be designed to be used multiple times. However, in either case, the various devices or components may be used again after being repaired after at least one use. Repair may include any combination of disassembly, cleaning or replacement of specific parts, and subsequent reassembly steps. Specifically, the device or component is detachable, and any number of specific parts or accessories thereof may be selectively replaced or removed in any combination. After cleaning and / or replacing specific accessories, the device or component may be reassembled for subsequent use at a repair facility or by a surgical team just before a surgical operation. The repair of a device or component may utilize various techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting repair device or component are within the scope of the present disclosure.

[0107] Various devices or components described herein can be processed before being used in surgical operations. For example, new or used devices or components can be obtained and cleaned as needed. Devices or components can be sterilized. In a sterilization technique, devices or components can be placed in closed and sealed containers (such as plastic or TYVEK bags). The container and its contents can be placed in a radiation field that can penetrate the container, such as gamma radiation, x-rays or high-energy electrons. Radiation can kill bacteria on devices or components and in containers. Sterilized devices or components can be stored in sterile containers. Sealed containers can keep devices or components sterile until they are opened in medical facilities. Other forms of sterilization can also be used, including beta radiation or other forms of radiation, ethylene oxide, steam or liquid baths (e.g., cold soaking). Due to factors such as the materials used, the presence of electronic components, some forms of sterilization may be more suitable for different devices or components or parts thereof.

[0108] In the present disclosure, phrases such as "at least one of ... " or "one or more of ... " may appear after the connected list of elements or features. The term "and / or" may also appear in 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 mean any of the elements or features listed separately or any of the elements or features combined with any of the elements or features listed with other 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 "single A, single B or A and B together". Similar explanations also apply to lists including three or more 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 "single A, single B, single C, A and B together, A and C together, B and C together or A and B and C together". In addition, the use of the term "based on" is intended to mean "based at least in part", so that unlisted features or elements are also allowed.

[0109] Additional features and advantages based on the above-described embodiments are possible and 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 expressly incorporated herein by reference in their entirety, unless any definition, subject matter waives or denies a claim, and unless the incorporated material is inconsistent with the express disclosure of this article, in which case the language of the present disclosure shall prevail.

[0110] Examples of the above embodiments may include the following:

[0111] 1. A surgical instrument, comprising:

[0112] proximal stem;

[0113] 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;

[0114] a locking portion configured to engage a unilateral portion of the implant;

[0115] a control shaft received within the hollow interior, the control shaft configured to translate distally to engage the implant engaged by the locking portion; and

[0116] A rotation knob is configured to engage the proximal end of the control shaft to translate the control shaft relative to the distal inserter portion to transition the locking portion from an unlocked configuration to a locked configuration to secure the locking portion to the implant.

[0117] 2. A surgical instrument according to embodiment 1, wherein the locking portion further comprises a retractable snap member which slides along the surface of the implant during distal translation of the control shaft to engage a groove formed in the implant.

[0118] 3. A surgical instrument according to Example 2, wherein the locking configuration also includes pulling the retractable latch upward and inward to force the proximal-facing bearing surface of the latch against the distal-facing bearing surface of the implant.

[0119] 4. A surgical instrument according to any one of embodiments 1 to 3, wherein the locking portion further comprises one or more insertion tabs and a stop beam, wherein the insertion tab engages a surface of the implant to lock to the implant, and the stop beam is configured to abut the implant to prevent further translation of the control axis.

[0120] 5. A surgical instrument according to any one of embodiments 1 to 4, wherein the distal inserter portion includes one or more attachment features extending therefrom, and the one or more attachment features are configured to be received in an auxiliary instrument to be connected to the auxiliary instrument.

[0121] 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.

[0122] 7. According to the surgical instrument of embodiment 5, the surgical instrument also includes a reduction instrument, which engages the one or more attachment features, and the reduction instrument has a reducer shaft, which is received in the housing to reduce the spinal rod into the implant.

[0123] 8. The surgical instrument of embodiment 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 attachment features therein.

[0124] 9. The surgical instrument of embodiment 7, wherein the reduction instrument further comprises a retaining lever coupled to the housing to facilitate locking the reduction instrument to the one or more attachment features.

[0125] 10. The surgical instrument according to embodiment 9, wherein the retaining lever is configured to

[0126] The housing is pivoted to lock the reduction instrument to the distal inserter portion.

[0127] 11. The surgical instrument of embodiment 7, wherein the reducer shaft comprises a drive interface configured to couple to an adapter for moving the reducer shaft relative to the housing.

[0128] 12. The surgical instrument of embodiment 7, wherein the reducer shaft comprises a proximal threaded portion and a distal translation portion, wherein rotation of the proximal threaded portion translates the distal portion into engagement with the spinal rod.

[0129] 13. The surgical instrument of embodiment 12, wherein the instrument provides counter-torque during spinal rod reduction.

[0130] 14. A surgical instrument, comprising:

[0131] proximal stem;

[0132] a longitudinal shaft coupled to the handle; and

[0133] An engagement feature portion is provided on the distal end of the shaft to engage one or more features of the implant, the side wall of the engagement feature portion defining a distally facing groove and having an internal threaded surface, the internal threaded surface being configured to couple to a corresponding feature portion of the implant, thereby coupling the shaft to the implant.

[0134] 15. The instrument of embodiment 14 wherein the side wall has an externally threaded surface configured to couple to a corresponding feature of the implant, thereby coupling the shaft to the implant.

[0135] 16. The apparatus of embodiment 15, wherein the inner threaded surface and the outer threaded surface are located on opposite surfaces of the side wall.

[0136] 17. The instrument of embodiment 16, wherein the inner threaded surface and the outer threaded surface are axially offset such that a distal end of the outer threaded surface is positioned proximal to a proximal end of the inner threaded surface.

[0137] 18. The instrument of embodiment 17, wherein the side wall tapers distally from a distal side of the external threaded surface.

[0138] 19. The instrument of any one of embodiments 14 to 18, wherein the side wall tapers distally from proximal to the internal threaded surface.

[0139] 20. The instrument of any one of embodiments 14 to 19, wherein the engagement feature further comprises a centering pin extending distally from the engagement feature, the centering pin being configured to be received in a portion of the implant.

[0140] 21. A surgical method, comprising:

[0141] placing a grasping instrument in contact with the implant, the grasping instrument having a longitudinal shaft including an engagement surface on a distal end thereof, the engagement surface having a reduced diameter portion with an internal thread;

[0142] Screwing the holding instrument into a first corresponding feature of the implant, the first corresponding feature being a surface corresponding to the internal thread; and

[0143] The implant is positioned relative to the surgical site using the grasping instrument.

[0144] 22. The method of embodiment 21, wherein the distal end of the holding instrument further comprises external threads, and the method further comprises:

[0145] decoupling the holding instrument from the first corresponding feature; and

[0146] The grasping instrument is screwed into a second corresponding feature of the implant, the second corresponding feature being a surface corresponding to the external thread.

[0147] 23. The method of embodiment 22, wherein the second corresponding feature comprises an internal thread formed in a recess of the implant.

[0148] 24. The method of any one of embodiments 21 to 23, wherein threading the holding instrument into the first corresponding feature further comprises engaging an external thread of a fixing screw with the internal thread.

[0149] 25. The method of embodiment 24, wherein the centering pin of the engagement surface is advanced distally into a recess of the set screw.

[0150] 26. A surgical method, comprising:

[0151] coupling an insertion instrument to an implant having opposing arms defining a recess such that the insertion instrument contacts only one of the opposing arms and maintains access to the recess;

[0152] using the insertion instrument to position the implant relative to a surgical site such that at least a portion of a fixation element is disposed within the recess of the implant; and

[0153] While maintaining the position of the implant using the insertion instrument, a fixation screw is inserted into the implant to capture the fixation element in the recess of the implant.

[0154] 27. The method of embodiment 26 further includes tightening the set screw by rotating the set screw in a first direction relative to the implant while transmitting a counter-torque force to the implant using the insertion instrument.

[0155] 28. The method of any one of embodiments 26 to 27, further comprising decoupling the insertion instrument from the implant.

Claims

1. A surgical instrument, comprising: proximal stem; 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 a unilateral 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; and A rotation knob is configured to engage the proximal end of the control shaft to translate the control shaft relative to the distal inserter portion to transition the locking portion from an unlocked configuration to a locked configuration to secure the locking portion to the implant.

2. The surgical instrument according to claim 1, wherein: The locking portion further includes a retractable catch that slides along a surface of the implant during distal translation of the control shaft to engage a groove formed in the implant.

3. The surgical instrument according to claim 2, wherein: The locked configuration further comprises pulling the retractable catch upwardly and inwardly to force the proximally facing bearing surface of the catch against the distally facing bearing surface of the implant.

4. The surgical instrument according to claim 1, wherein: The locking portion also includes one or more insertion tabs that engage a surface of the implant to lock to the implant and a stop beam configured to abut the implant to prevent further translation of the control shaft.

5. The surgical instrument according to claim 1, wherein: The distal inserter portion includes one or more attachment features extending therefrom that are configured to be received in an auxiliary instrument to couple with the auxiliary instrument.

6. The surgical instrument according to claim 5, wherein: The one or more attachment features also include one or more pins extending from the body of the distal inserter portion.

7. The surgical instrument of claim 5, further comprising a reduction instrument that engages the one or more attachment features, the reduction instrument having a reducer shaft received in the housing to reduce the spinal rod into the implant.

8. The surgical instrument according to claim 7, wherein: The housing also includes one or more arms extending therefrom, the arms having one or more tracks for receiving the one or more attachment features therein.

9. The surgical instrument according to claim 7, wherein: The reduction instrument also includes a retention lever coupled to the housing to facilitate locking the reduction instrument to the one or more attachment features.

10. The surgical instrument according to claim 9, wherein: The retaining lever is configured to pivot relative to the housing to lock the reduction instrument to the distal inserter portion.

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

12. The surgical instrument according to 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 according to claim 12, wherein: The instrument provides counter torque during spinal rod reduction.

14. A surgical instrument, comprising: proximal stem; a longitudinal shaft coupled to the handle; and An engagement feature portion is provided on the distal end of the shaft to engage one or more features of the implant, the side wall of the engagement feature portion defining a distally facing groove and having an internal threaded surface, the internal threaded surface being configured to couple to a corresponding feature portion of the implant, thereby coupling the shaft to the implant.

15. The apparatus according to claim 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.

16. The apparatus according to claim 15, wherein: The inner thread surface and the outer thread surface are located on opposite surfaces of the side wall.

17. The apparatus according to 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 proximally of a proximal end of the internal threaded surface.

18. The apparatus according to claim 17, wherein: The side wall tapers distally from the distal side of the external thread surface.

19. The apparatus of claim 14, wherein: The side wall tapers from the proximal side of the inner thread surface toward the distal side.

20. The apparatus of claim 14, wherein: The engagement feature also includes a centering pin extending distally from the engagement feature, the centering pin being configured to be received in a portion of the implant.

Citation Information

Patent Citations

  • Unilateral implant holders and related methods

    US10966762B2