sequential reset

Abstract

The present invention provides surgical instruments configured to engage with bone anchor assemblies to provide modular platforms for performing various steps of surgical procedures, such as spinal rod reduction and counterrotation. For example, in one embodiment, the surgical instrument may include an outer sleeve terminating in a pair of extensions, an inner sleeve having a proximal threaded portion and a distal translational portion and configured to pass through the outer sleeve, and a pair of pivoting arms received in the extensions of the outer sleeve. These pivoting arms may be configured to extend into a channel in the outer sleeve to engage the bone anchor to the outer sleeve, and the proximal end portion of the outer sleeve may include one or more flat portions configured to engage with another instrument.

Description

Technical Field

[0001] This disclosure relates generally to surgical instruments and methods of use, and more specifically to surgical instruments for performing rod reduction, counterrotation and / or fixation screw insertion during spinal surgery. Background Technology

[0002] Fixation systems can be used in orthopedic or neurosurgical procedures to maintain a desired spatial relationship between multiple bones or bone fragments. For example, in spinal surgery, a spinal fixation system can be implanted into the patient to align and / or fix one or more vertebrae to a desired orientation. A typical spinal fixation system may include a bone anchor implanted in the vertebra and a longitudinal bar fixed to the bone anchor by a fixation screw or other closure mechanism. Implantation of a fixation system can involve multiple steps, such as bar repositioning, counter-rotation, and fixation screw insertion.

[0003] Rod reduction, counterrotation, and screw management can be among the most challenging aspects of posterior spinal fixation procedures. Traditionally, multiple separate instruments are required to perform these steps. Consequently, a large number of instruments must be prepared and served during surgery, the surgeon must repeatedly switch between several different instruments, and there may be a need for frequent insertion, removal, and reinsertion of instruments into and out of the surgical site. All of this can lead to surgeon fatigue, prolonged surgical time, and associated patient risks.

[0004] Therefore, there is a need for improved instruments, systems, and methods that can reduce the number of steps and instruments required to perform spinal fixation procedures. Summary of the Invention

[0005] This disclosure relates in its entirety to various embodiments of rod repositioning devices and counterrotation sleeves that address challenges related to the workflow, usability, and manufacture of the devices. Exemplary devices may include an outer sleeve configured to engage with a bone anchor assembly to provide a modular platform for performing various steps of a surgical procedure. For example, the outer sleeve may receive an inner sleeve passing through it for repositioning a spinal rod into the bone anchor assembly. The inner sleeve may include threaded members and translational members that contact the rod to drive it distally into the bone anchor assembly. A counterrotation device may be attached to the repositioning device to perform a counterrotation operation or apply other manipulating forces. A modular actuator or handle adapter may be attached to the repositioning device and / or the counterrotation device to facilitate rod repositioning. Any of the device body, the repositioning device, and the counterrotation device may include a working channel passing through it. A fixing screw or closure mechanism and a drive device for applying the fixing screw or closure mechanism to the bone anchor assembly may be inserted through the working channel.

[0006] In one aspect, a surgical instrument is disclosed, comprising an outer sleeve having an inner channel defined therein, the outer sleeve terminating at a pair of extensions at its distal end. The instrument also includes an inner sleeve having a proximal threaded portion and a distal translational portion and configured to pass through the outer sleeve, and a pair of pivot arms received in the extensions within the outer sleeve. The pivot arms are configured to extend into the channel to engage a bone anchor to the outer sleeve. Furthermore, the proximal end portion of the outer sleeve includes one or more flat portions configured to engage with another instrument.

[0007] It may include any of a variety of alternative or additional features and may be considered within the scope of this disclosure. For example, in some embodiments, the pivot arm may be spring-loaded to bias to a closed position.

[0008] In some embodiments, the threaded portion may include a first threaded portion and a second threaded portion separated from the non-threaded portion.

[0009] In some implementations, the threaded portion may be configured to be pulled and rotated to be removed from the outer sleeve.

[0010] In some embodiments, the proximal end portion of the outer sleeve may include a circumferential groove.

[0011] In some embodiments, the pair of pivot arms may include a protrusion extending into one or more longitudinal grooves in the distal translational portion of the inner sleeve to prevent rotation of the distal translational portion relative to the outer sleeve. In other embodiments, the device may include a pin extending into one or more longitudinal grooves in the distal translational portion of the inner sleeve to prevent rotation of the distal translational portion.

[0012] In some embodiments, the device may also include a torque-counteracting device having a mating feature corresponding to one or more flat portions on the outer sleeve.

[0013] In some embodiments, the device may further include a counter-rotating sleeve defining an inner cavity therethrough, the counter-rotating sleeve being configured to engage with an outer sleeve. The counter-rotating sleeve may have one or more engagement surfaces that overlap with one or more flat portions to facilitate engagement. In some embodiments, the counter-rotating sleeve may further include a pair of hinged arms configured to extend into the inner cavity to further engage the counter-rotating sleeve with the outer sleeve. In some embodiments, the counter-rotating sleeve may further include a locking ring configured to selectively restrain movement of the hinged arms. Furthermore, in some embodiments, the hinged arms may be received in a circumferential groove along the outer sleeve.

[0014] In another aspect, a surgical instrument is disclosed, comprising: a housing having a central opening, a proximal end, a distal end, and a central longitudinal axis (A1) extending between the proximal and distal ends. The instrument also includes a first and a second fixation arm extending distally from the housing, and a first and a second pivot arm movably coupled to the housing. Each pivot arm may have a proximal end and a distal end, wherein the pivot arm is configured to selectively retain a bone anchor between them. The instrument also includes a reductant shaft threaded into the central opening of the housing. Furthermore, each of the first and second arms extends distally from the housing to define an inner surface, and each of the first and second arms includes a sidewall extending outwardly from the inner surface at a lateral end of each arm.

[0015] As with the aforementioned apparatus, any of a variety of additional or alternative features is considered to be within the scope of this disclosure. For example, in some embodiments, the inner surface of each of the first and second arms may have a tapered profile.

[0016] In some implementations, the opposing inward-facing surfaces of each sidewall of the arm may have a planar tapered profile.

[0017] In some implementations, the pivot arm may be mounted in a recess formed in the fixed arm.

[0018] In some implementations, the pivot arm may be pivotally connected to the housing at a location midway between the proximal and distal ends of the pivot arm.

[0019] In some embodiments, the reset shaft may include a first portion having external threads and configured to rotate relative to the housing to advance the reset shaft distally relative to the housing. The reset shaft may also include a second portion rotatably fixed relative to the housing, the second portion including a distally facing rod engagement surface. The first portion may include one or more inwardly facing protrusions received within a circumferential groove formed in the outer surface of the second portion.

[0020] In some implementations, the reset shaft may define a working channel extending through it.

[0021] In some implementations, the distal end portion of the resetter shaft may include a visualization window formed therein.

[0022] In some implementations, the reset shaft may include a drive interface at the proximal end of the reset shaft.

[0023] In some implementations, the reset shaft may include a handle at its proximal end, the handle being configured to be gripped by a user.

[0024] In some embodiments, the device may further include a counter-rotating shaft selectively attached to the reset shaft. In some embodiments, the counter-rotating shaft may include an elongated body defining a working channel extending therethrough, the working channel of the counter-rotating shaft communicating with the working channel of the reset shaft and a central opening of the housing. In other embodiments, the counter-rotating shaft may include opposing hinge arms and a locking ring. The locking ring is movable between a locked position and an unlocked position, in which the locking ring holds the hinge arm in a radially inward position, in which the hinge arm engages a groove formed in the housing, and in the unlocked position, the hinge arm is movable radially outward to disengage from the groove in the housing.

[0025] In some implementations, the counter-rotating shaft may include a drive interface at the proximal end of the counter-rotating shaft.

[0026] In some embodiments, the sidewall may include an extension forming a notch between each extension and the inner surface. The notch may be configured to receive part of a bone anchor.

[0027] In some embodiments, the reductator shaft may include a generally flat distal surface configured to engage the spinal rod. In other embodiments, the reductator shaft may include a recessed distal surface configured to engage the spinal rod.

[0028] Any of the features or variations described herein may be applied in a variety of different combinations to any particular aspect or implementation of this disclosure. No particular combination is explicitly described merely to avoid unnecessary length or redundancy. Attached Figure Description

[0029] The aspects and embodiments of this disclosure will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:

[0030] Figure 1 This is a side view of one embodiment of the resetter device of this disclosure;

[0031] Figure 2 yes Figure 1 An exploded perspective view of the reset device;

[0032] Figure 3 yes Figure 1 Detailed side sectional view of the reset device;

[0033] Figure 4 yes Figure 1 Side view of the inner sleeve of the reset device;

[0034] Figure 5 This is a perspective view of another embodiment of the resetter device according to this disclosure;

[0035] Figure 6This is a perspective view of one embodiment of the repositioning device of this disclosure, connected to a bone anchor and a spinal fixation rod;

[0036] Figure 7 This is a perspective view of another embodiment of the resetter device of this disclosure having an extended inner sleeve;

[0037] Figure 8 This is a perspective view of another embodiment of the resetter device of this disclosure having an inner sleeve of intermediate length;

[0038] Figure 9A It involves engaging the bone anchor with an inner sleeve positioned proximally. Figure 7 A side sectional view of the reset device;

[0039] Figure 9B It involves engaging the bone anchor with an inner sleeve positioned proximally. Figure 8 A side sectional view of the reset device;

[0040] Figure 9C It involves engaging the bone anchor with an inner sleeve positioned proximally. Figure 6 A side sectional view of the reset device;

[0041] Figure 9D It involves engaging the bone anchor with the inner sleeve positioned distally. Figure 7 A side sectional view of the reset device;

[0042] Figure 9E It involves engaging the bone anchor with the inner sleeve positioned distally. Figure 8 A side sectional view of the reset device;

[0043] Figure 9F It involves engaging the bone anchor with the inner sleeve positioned distally. Figure 6 A side sectional view of the reset device;

[0044] Figure 10 This is an exploded perspective view of one embodiment of the resetter device disclosed herein;

[0045] Figure 11 yes Figure 10 A perspective view of the instrument;

[0046] Figure 12 It is positioned above the spinal column and adjacent to the bone anchor. Figure 10 Side view of the resetter device;

[0047] Figure 13 It is connected to the bone anchor. Figure 12 Side view of the resetter device;

[0048] Figure 14 It is connected to the bone anchor. Figure 12 Side view of the resetter device;

[0049] Figure 15 It is Figure 12 A side view of the reset device performing initial rod reset;

[0050] Figure 16 It is Figure 12 A side view of the reset device performing intermediate rod reset;

[0051] Figure 17 It is Figure 12 A side view of the resetting device for distal rod resetting;

[0052] Figure 18 It is facing Figure 17 A perspective view of the fixation screws advancing the spinal rod towards distal reduction;

[0053] Figure 19 Through Figure 12 A lateral sectional view of the repositioning device connected to the fixation screw of the bone anchor.

[0054] Figure 20 Is Figure 12 A side sectional view of the reverse rotation operation performed on the reset device;

[0055] Figure 21 Is Figure 12 A side sectional view of the opening operation performed on the reset device;

[0056] Figure 22 It is connected to Figure 12 A side view of the anti-torque device of the reset instrument;

[0057] Figure 23 It is introduced into Figure 22 Side view of the driver in the inner sleeve of the reset device;

[0058] Figure 24 It is connected to Figure 1 Side view of the modular counter-rotating sleeve of the outer sleeve of the reset device;

[0059] Figure 25 yes Figure 24 Perspective view of the modular anti-rotation sleeve;

[0060] Figure 26 yes Figure 24 Exploded perspective view of the modular counter-rotating sleeve;

[0061] Figure 27 yes Figure 24 Detailed perspective view of the distal end of the modular anti-rotation sleeve;

[0062] Figure 28 It is connected to Figure 1 The outer sleeve of the reset device Figure 24 Perspective view of the modular anti-rotation sleeve;

[0063] Figure 29 yes Figure 24 Modular counter-rotating sleeve and Figure 1 A side sectional view of the connection between the outer sleeves;

[0064] Figure 30 It is connected to Figure 1 Reset device Figure 22 Side view of the anti-torque device;

[0065] Figure 31 It is connected to Figure 24 The components Figure 22 Side view of the anti-torque device;

[0066] Figure 32 This is a perspective view of one embodiment of the resetter device disclosed herein;

[0067] Figure 33 yes Figure 32 An exploded perspective view of the reset device;

[0068] Figure 34 It connects to the bone anchor and repositions the spinal rod. Figure 32 A perspective view of the resetter device;

[0069] Figure 35 yes Figure 32 Detailed perspective view of the distal end of the outer sleeve of the reset device;

[0070] Figure 36 It is connected to the bone anchor. Figure 34 Detailed perspective view of the reset device;

[0071] Figure 37 It connects to the bone anchor and repositions the spinal rod. Figure 32 Detailed side view of the resetter device;

[0072] Figure 38 It is the section AA along the line. Figure 37 A side sectional view of the reset device;

[0073] Figure 39 It is a section taken along line BB. Figure 37 A transverse sectional view of the reset device facing the distal side;

[0074] Figure 40 yes Figure 32 A perspective view of the inner sleeve of the reset device;

[0075] Figure 41 It is a side view of one embodiment of an inner sleeve having a recessed distal surface;

[0076] Figure 42 yes Figure 34 Side sectional view of the repositioning device and bone anchor;

[0077] Figure 43 This is an exploded perspective view of one embodiment of a resetter device with a pin coupling mechanism;

[0078] Figure 44 yes Figure 43 A partial perspective view of the resetter device, in which the outer sleeve of the device is hidden in the view;

[0079] Figure 45 yes Figure 43 A side sectional view of the reset device;

[0080] Figure 46 This is an exploded perspective view of another embodiment of the inner sleeve with an integrated proximal handle; and

[0081] Figure 47 This is a perspective view of one embodiment of an actuator device extending through the outer sleeve of a repositioning device, the actuator device being coupled to a bone anchor to drive the implantable shank of the bone anchor. Detailed Implementation

[0082] Certain exemplary embodiments will now be described to provide an overall understanding of the principles of 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 drawings are non-limiting embodiments. Features shown or described in one embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of this disclosure. Furthermore, the use of linear dimensions, circular dimensions, or other dimensions in the description of the disclosed devices and methods is not intended to limit the types of shapes that may be used in conjunction with such devices and methods. Equivalents of such dimensions may be determined for different geometries, etc. Additionally, components with similar numbers in the embodiments may generally have similar features. Furthermore, the size and shape of the devices and their components may depend at least on the anatomy of the subjects who will use these devices, the size and shape of the objects that will be used with these devices, and the methods and procedures for using these devices.

[0083] This document discloses various embodiments of rod repositioning devices and counter-rotation sleeves that address challenges related to the workflow, usability, and manufacturing of the devices. Exemplary devices may include an outer sleeve configured to engage with a bone anchor assembly to provide a modular platform for performing various steps of a surgical procedure. For example, the outer sleeve may receive an inner sleeve passing through it for repositioning a spinal rod into the bone anchor assembly. The inner sleeve may include threaded members and translational members that contact the rod to drive it distally into the bone anchor assembly. A counter-rotation device may be attached to the repositioning device to perform a counter-rotation operation or apply other manipulating forces. A modular actuator or handle adapter may be attached to the repositioning device and / or the counter-rotation device to facilitate rod repositioning. Any of the device body, the repositioning device, and the counter-rotation device may include a working channel passing through it. A fixing screw or closure mechanism and a drive device for applying the fixing screw or closure mechanism to the bone anchor assembly may be inserted through the working channel.

[0084] The instruments and devices disclosed herein can be used in the same procedures as those described in U.S. Patent 10,610,269 entitled “Modular surgical instruments and related methods,” the entire disclosure of which is incorporated herein by reference. The instruments and devices disclosed herein may be advantageous for certain clinical applications, providing the ability to engage with an implant independently of the rod repositioning process. For example, as described below, the disclosed instruments and devices can facilitate engagement with an implant before or after implantation into a patient. Once positioned relative to a spinal fixation rod or other element, the disclosed instruments and devices can achieve rod repositioning via actuation of a threaded mechanism. In some surgical procedures, the disclosed instruments and devices can be operated to engage with an implant construction, repositioning the rod into the implant, allowing the user to lock the rod into or out of the implant construction, for example, using a fixation screw, and repeat the same or similar operations to reposition the rod into another implant construction.

[0085] As described above, the disclosed instruments and devices can be coupled to the implant before the rod reduction procedure begins. This feature provides, for example, the option to lock multiple repositioning devices to their respective implant structures before the rod reduction procedure is performed. The repositioning devices can remain independent without user input to maintain their position and / or the degree of rod reduction, and they can operate individually to reposition or partially reposition the rod into each of the respective implants, thereby allowing the surgeon to sequentially perform the entire reduction procedure along the patient's spine without disengaging and re-engaging the repositioning devices to different implants. In some embodiments, the repositioning devices can be used to temporarily hold the rod in the desired position until the surgeon is satisfied with the entire reduction procedure. Once the rod is fully repositioned into the implant structure, the rod can be locked into the respective implant structure by applying a fixing screw or other fixation device through the lumen formed in each repositioning device, as described below.

[0086] Figure 1 and Figure 2 One embodiment of the reductator device 100 of this disclosure is shown, which can be used to provide a platform for various surgical procedures, such as rod reduction, counter-rotation, and / or fixation screw insertion. The reductator device 100 may include an outer sleeve 102, an inner sleeve 104, and a pair of pivoting arms 106 attached to the outer sleeve. The outer sleeve 102 may define a working channel 108 configured to receive at least a portion therein of another tool or instrument (e.g., the inner sleeve 104). The channel 108 provides access to the surgical site to allow an instrument or implant to pass through it. The channel 108 may extend from a proximal end 100p of the reductator device 100 to a distal end 100d of the reductator device. A pin 110 may engage the arms 106 to the outer sleeve 102.

[0087] In use, the reduction device 100 can be positioned such that the pivot arms 106a, 106b engage with the bone anchor 10 disposed therebetween, to mate the reduction device 100 with the bone anchor 10, for example as... Figures 6 to 8 As shown. The pivot arm can be a spring-loaded lever arm, which is biased to a closed position to allow the screw (or hook) head to remain in place during lever reset. Figure 3 An example is shown using a helical spring 119 to bias arms 106a, 106b. The bone anchor may include a handle 12 and a receiver head or member 14 into which a rod 16 can be repositioned. In some embodiments, the repositioning device allows for the insertion of a bone anchor or screw pre-attached to the repositioning device, such that a screw inserter travels through a channel 108 of the outer sleeve 102 to deliver the bone screw into bone, such as the pedicle. An example of this configuration is described in more detail below. Figure 47 As shown in the image.

[0088] The outer sleeve 102 may include a generally tubular central portion terminating at a first extension 112a and a second extension 112b. The extensions 112a and 112b have one or more recesses formed therein to receive the extensions 112a and 112b. The outer sleeve 102 may be defined by a sidewall 114 of an external channel 108. The inner surface of the channel 108 may be threaded or may include other mating features for engaging with an instrument, such as an inner sleeve 104 inserted therethrough, to longitudinally advance the instrument relative to the outer sleeve 102.

[0089] The inner sleeve 104 may include a proximal threaded member 120 and a distal translation member 122. Figure 3 The relationship between the two components is shown in more detail. As shown, the threaded component 120 and the translational component 122 can be connected via a series of radially oriented pins or protrusions 117, which protrude from the inner surface of the threaded component 120 and are received in circumferential grooves formed in the outer surface of the distal translational component 122. As shown, washers 124 (e.g., thrust washers) made of polymer or abrasion-resistant metal material can be separated and serve as a support surface between the translational component and the threaded component.

[0090] In some embodiments, the translation member 122 may include one or more longitudinal grooves 123 formed therein. In some embodiments, the protrusion 127 may be integrally formed on the pivot arms 106a, 106b, eliminating the need for pins to hold it in place. That is, the longitudinal groove 123 may engage with a cam-shaped semi-circular surface or protrusion 127 on the underside of the lever fulcrum to prevent rotation of the translation member during reset. This can replace the use of conventional pins to minimize manufacturing, welding, and assembly complexity. However, in some embodiments, one or more pins may be used instead of the protrusion 127, such as... Figures 43 to 45 As shown and explained in more detail below. Returning to the bump 127, which extends from the surface of the arm 106 and straddles the longitudinal groove 123 to facilitate translation but prevent rotation of the translation member 122.

[0091] Figure 4The threaded member 120 is shown in more detail. As shown, the threaded member 120 may include multiple threaded portions formed thereon. For example, the threaded member 120 may include a first threaded portion 126 and a second additional distal threaded portion 128, which prevents the threaded member 120 from unintentionally moving out of the outer sleeve 102 from the proximal side while still allowing complete removal from the outer sleeve 102 for cleaning. In use, the first and second threads of the inner sleeve 104 are screwed into the outer sleeve 102 to fully reposition the spinal rod into the bone anchor, and both the first and second threads are unwound from the outer sleeve 102 to remove the inner sleeve 104 from the outer sleeve. More specifically, the first and second threaded portions may be separated by a non-threaded portion 130. The non-threaded portion 130 may include alternative surface features, such as ribs, bumps, or other features. The presence of the non-threaded portion 130 allows feedback to the user that they have retracted the inner sleeve 104 subassembly or the reset shaft to its maximum extent, as the inner sleeve 104 will translate freely relative to the outer sleeve 102 once the threaded portion 126 disengages. However, to completely remove the inner sleeve 104 subassembly from the outer sleeve 102, the user will have to pull proximally to translate the inner sleeve 104 and rotate to engage the second threaded portion 128 at the distal end of the threaded member 120. The inner sleeve 104 subassembly can only be completely removed from the outer sleeve when the second threaded portion 128 is completely disengaged by screwing proximally relative to the outer sleeve 102. That is, the removal of the inner sleeve 104 relative to the outer sleeve 102 is performed using a combination of pulling / pushing and rotation, which prevents unintended disengagement of the inner sleeve 104.

[0092] In some embodiments, the threaded member 120 includes a three-lead, short-cut trapezoidal thread to minimize profile, increase reset speed, and reduce mechanical benefits to produce an enhanced tactile response. However, other thread forms are also possible. This can be achieved, for example, by balancing performance under various load conditions (e.g., axial loads versus lateral loads), device size (e.g., desired thread outer diameter), etc. For example, in some embodiments, a centrally located trapezoidal thread can be used to provide enhanced performance (e.g., greater resistance to thread binding) under lateral load conditions. Other possible thread forms include trapezoidal, square, and off-center trapezoidal threads. In some embodiments, aspects of one or more thread forms can be combined to create a modified thread form. Furthermore, in some embodiments, the threaded member 120 may include an internal channel defined therein for receiving one or more devices, such as retaining screws, passing through it.

[0093] The threaded member 120 may also include a proximal drive interface 402 for transmitting torque during use. In some embodiments, the proximal drive interface 402 may be a modular drive interface including one or more flat portions or other torque transmission features formed thereon. In the illustrated embodiment, the proximal drive interface 402 is a hexagonal drive interface including a plurality of flat portions spaced circumferentially around the member 120. Such a modular drive interface can maintain a low profile / small diameter of the threaded member 120 while facilitating attachment to any of a variety of actuators or other instruments when needed. In some embodiments, any of a variety of user-gripable handles or other structures may be modularly coupled to the threaded member 120 using the proximal drive interface 402. In other embodiments, any of a variety of user-gripable handles or other structures may be integrally formed or otherwise permanently coupled to the threaded member 120 instead of Figure 4 The modular proximal drive feature 402 is shown. Figure 46 An embodiment of an inner sleeve 304 is shown, which has a threaded member 320 integrally formed with a handle 326 at its proximal end.

[0094] like Figure 5 As shown, the distal translation member 122 includes a first static or fixed arm 134a and a second static or fixed arm 134b extending distally therefrom for performing rod reset. The static arms 134a, 134b can be configured to advance distally without rotation to advance the spinal rod into the receiver member. Figure 1 As shown, the translation member 122 may include a window 125 to allow observation of the fixing screw during tightening and loosening, as it is screwed into the bone anchor, as discussed further below. The window 125 may have various shapes and sizes, including... Figure 1 The teardrop shape shown or Figure 40 The slit shape is shown. Furthermore, the window 125 can be positioned at various locations along the length of the translation member 122. In some embodiments, the window can be positioned sufficiently close to the distal end of the translation member 122 to allow visualization of the fixation screw after it has been fully screwed into the receiver member of the bone anchor. In some embodiments, a longer slit-shaped window can provide greater visualization of the fixation screw during insertion and tightening operations, while also maximizing the strength and stiffness of the translation member 122, which can be reduced if too much material is removed, especially closer to the distal end of the translation member. Returning to the inner sleeve 104, more generally, the inner sleeve is translatable relative to the outer sleeve 102.

[0095] Figure 5An embodiment of the inner sleeve 104a without any windows within the outer sleeve is shown. The outer sleeve 102 has a distal recess 131 formed between opposing arms 112a, 112b, which receives and engages with a receiver member of the bone anchor. The size of the distal recess 131 can vary, but in some embodiments, the window 131 can be approximately 9 mm wide. The size and shape of the distal end of the outer sleeve 102 allow engagement with the bone anchor even with a certain amount of lateral misalignment. Furthermore, the inner surfaces of the arms 112a, 112b can have a shape or profile complementary to the outer surface of the bone anchor to facilitate engagement even with a certain amount of misalignment, whether the misalignment is, for example, lateral misalignment or rotational misalignment along the axis of the rod, rotational misalignment along the longitudinal axis of the device 100, etc. In some embodiments, for example, the inner surface 132 of each arm 112a, 112b may include a tapered profile complementary to the outer surface of the opposing arm of the multiaxial bone anchor receiver head. In some cases, the inner surface 132 of each arm 112a, 112b may include a tapered profile complementary to the tapered profile of the receiver member. Such an arrangement allows for some pivot misalignment between the receiver head and the instrument 100, which can be corrected as the instrument advances distally relative to the receiver head and the receiver head advances into the distal recess 131.

[0096] Furthermore, arms 112a, 112b may include sidewalls 133 extending outward from the inner surface 132 at the lateral ends of each arm. The sidewalls 133 may similarly include tapered profiles to aid alignment with the receiver member of the bone anchor, for example, by self-correcting for rotational misalignment about the longitudinal axis of the device when the device is advanced distally relative to the bone anchor and the anchor is received within the distal recess 131. In some embodiments, the opposing inward-facing surfaces of each sidewall 133 may have planar tapered profiles that are complementary to the planar tapered profiles of adjacent surfaces on the bone anchor receiver member. When the device 100 is coupled to the bone anchor, the various tapered surfaces can accommodate misalignment such that advancement of the outer sleeve 102 over the bone anchor 10 forces the two components to be correctly aligned just before the pivot arms 106a, 106b engage with the shape-fitting engagement of the anchor 10, simplifying the attachment of the device 100 to the anchor 10. As noted, the receiver member 14 may include one or more tapered profiles complementary to the tapered surfaces disposed on the outer sleeve. Further details regarding the features of the anchor 10 that can be used with the apparatus disclosed herein can be found in U.S. Patent Nos. 10,039,578 and 10,299,839, and U.S. Provisional Application No. 63 / 157,362, filed March 5, 2021, entitled “Multi-Feature Polyaxial Screw.” The entire contents of each of these applications are incorporated herein by reference.

[0097] The proximal end of the outer sleeve 102 may include one or more mating features. For example, the outer sleeve 102 may include one or more proximal flat portions 144 having a square or rectangular shape oriented around its circumference. The flat portions 144 may be spaced apart around the circumference of the outer sleeve to engage with corresponding mating features of an instrument that engages with the outer sleeve. Furthermore, the outer sleeve 102 may include circumferential grooves 145 extending around the circumference of the outer sleeve 102 to facilitate engagement between the outer sleeve and an instrument, as discussed further below. As shown, the circumferential grooves 145 may be oriented away from the flat portions 144, but it should be understood that their relative orientations may be reversed.

[0098] Figure 5 It is also shown that, in some embodiments, the actuators intended for surgeons can be distinguished from the rest of the device using different colors, textures, materials, etc. For example, in Figure 5 In one implementation, the surgically operated actuator 135 of arms 106a and 106b may be colored black using, for example, an aluminum titanium nitride (AlTiN) coating.

[0099] The length of the inner sleeve can be varied. Figure 6 A repositioning device 100' with a shorter inner sleeve 104' is shown. In some embodiments, the inner sleeve 104' provides approximately 20 mm of axial rod repositioning. The use of the short inner sleeve 104' can prevent proximal congestion in lordotic / concave segments of the spine, or is particularly useful in space-constrained pediatric applications.

[0100] Figure 7 A repositioning device 100'' with an extended inner sleeve 104'' is shown. In some embodiments, the inner sleeve 104'' provides approximately 60 mm of axial rod repositioning. In some embodiments, the extension length can be achieved by welding or otherwise joining two or more components to create the inner sleeve. When using an extended sleeve 104'' with an increased repositioning range, alternative surgical techniques may be possible, which involve inserting the rod after the repositioning device has been attached to the anchor.

[0101] Figure 8 It shows having in Figure 6 and Figure 7 The resetter device 100''' is an inner sleeve 104''' of intermediate length between the shown lengths. In some embodiments, this intermediate length inner sleeve 104''' provides approximately 40 mm of axial rod reset and is suitable for a variety of applications.

[0102] Figures 9A to 9FA cross-sectional view of a reduction device 100 having inner sleeves 104 of various lengths disposed therein is shown. More specifically, each of the figures shows a reduction device 100 with an inner sleeve of different lengths, which engage bone anchors with their respective pivot arms 106a, 106b. For example, Figure 9A and Figure 9D It shows that for Figure 7 The possible axial reset range of the device 100'' shown is because Figure 9A The device 100'' is shown with the inner sleeve 104'' in the proximal position, and Figure 9B The device 100'' is shown with the inner sleeve 104'' in the distal position. Figure 9B and Figure 9E China regarding Figure 8 The intermediate length instrument 100'' repeats this pattern, and... Figure 9C and Figure 9F China regarding Figure 6 The shorter instrument repeats the pattern 100'.

[0103] Figure 10 An embodiment of the components of the resetter device 100 of this disclosure is shown, and Figures 10 to 23 One embodiment of a method utilizing such an apparatus is shown. (Reference) Figure 10 The illustrated device 100 has an inner sleeve 104 that can be translated distally through an opening in the outer sleeve 102 to house the translation member 122 therein. Once assembled, as... Figure 11 As shown, the threaded member 120 can extend from the outer sleeve 104 toward the proximal side, while the translation member 122 is kept in the outer sleeve so that when the threaded member 120 rotates relative to the outer sleeve 102, it is pushed toward the distal side toward the extensions 112a, 112b of the outer sleeve.

[0104] Figure 12 A reduction device 100 is shown, engaging above and adjacent to the bone anchor or pedicle screw 14. As shown, the spinal rod 16 may be positioned between the pivot arms 106a, 106b and the extensions 112a, 112b of the outer sleeve 102, while the receiver member 14 is positioned distal to the outer sleeve 102. The outer sleeve 102 may be advanced toward the bone anchor 10 to engage its notch. Figure 12 One embodiment is shown in which the repositioning device 100 is advanced distally to first pass over and capture the rod 16 between the extensions 112a, 112b, and then approach the bone anchor 14. However, in other embodiments, the repositioning device may be coupled to the bone anchor before the rod is placed. In such embodiments, the rod may be laterally introduced into the space between the extensions 112a, 112b. Further discussion of such embodiments follows.

[0105] Figure 13 A resetting device 100 engaging with receiver member 14 is shown. As shown, during engagement, pivot arms 106a, 106b move radially outward at their distal ends to pass over a notch in the receiver member as the outer sleeve 102 is positioned over the receiver member. Once the outer sleeve 102 has been sufficiently advanced over the receiver member 14, the distal ends of the pivot arms 106a, 106b move radially inward toward the receiver member to engage in place (e.g., due to biasing forces, such as radially outward spring forces applied to the proximal ends of the pivot arms). As described above, during engagement along the axis of device 100, the tapered sidewall 132 allows for a certain amount of initial rotational misalignment between the outer sleeve 102 and the implant head 14.

[0106] Figure 14 A reduction device 100 is shown that engages with a pedicle screw 10, wherein a rod 16 is positioned between pivot arms 106a, 106b and extensions 112a, 112b of the outer sleeve 102. The aforementioned processes for assembling the reduction device 100 and / or attaching the outer sleeve 102 of the reduction device to the bone anchor can be performed in multiple sequences, allowing flexibility in different surgical workflows, thus improving efficiency and adapting to different user preferences. For example, the assembly of the inner sleeve component and the outer sleeve component of the device 100 can be performed in the "backstage" or surgical preparation area, and then the assembled device can be handed to the surgeon for use. Furthermore, the bone anchor can be attached to the outer sleeve 102 before or after implantation into the patient and / or before or after the assembly of the outer sleeve 102 and the inner sleeve 104.

[0107] In some embodiments, for example, the outer sleeve 102 may be coupled to the bone anchor before it is implanted into the patient, and the bone anchor may be implanted using an instrument that passes through the outer sleeve 102 to engage with the implantable shank of the bone anchor. This may be done with or without the inner sleeve 104 coupled to the outer sleeve 102. In embodiments where the bone anchor is implanted and the outer sleeve 102 is coupled thereto, but without the inner sleeve 104, the inner sleeve may be coupled to the outer sleeve 102 after the bone anchor has been implanted and the actuator has been removed from the outer sleeve 102.

[0108] Figure 47An embodiment of an actuator device 4702 is shown extending through an outer sleeve 102 of a reductant device coupled to a receiver member 14 of a bone anchor 10. The actuator device 4702 is shown as an implantable shank 12 coupled to the bone anchor 10, such that rotation of the actuator device causes rotation of the implantable shank to drive it into the bone. As noted above, once the implantable shank 12 is positioned in the bone, the actuator device 4702 can be removed proximally to separate from the shank 12 and withdrawn from the lumen of the outer sleeve 102. An inner sleeve 104 can then be coupled to the outer sleeve 102 to continue the rod capture and reduction process disclosed herein (e.g., the rod can be laterally introduced through a rod slot in the outer sleeve, and the inner sleeve can be rotated relative to the outer sleeve to achieve axial reduction of the rod toward the bone anchor 10).

[0109] This flexibility in assembly allows for workflows such as the following: in which the repositioning device 100 is coupled to the bone anchor and actuator device in the "backstage" or surgical preparation area. The assembly can then be passed to the surgeon or other user, ready for implantation of the bone anchor into the patient. After implantation, the actuator device can be removed, leaving the repositioning device 100 coupled to the implanted bone anchor and ready for repositioning the rod as described below. In embodiments where the outer sleeve 102 is coupled to the bone anchor before implantation or otherwise approximately before the rod is placed near the bone anchor, the rod can later be placed by laterally passing the rod slot opening of the outer sleeve 102 through the extensions 112a, 112b.

[0110] Figure 15 A rotational force 1502 is shown applied to the threaded member 120 to advance the translation member 122 toward the spinal bar. As shown, the threaded member 120 is rotatable while the translation member 122 moves distally to allow the static arm 134 to engage the spinal bar 16.

[0111] Figure 16 Further rotation of the threaded member 120 is shown, in which the stationary arms 134a, 134b advance the spinal rod 16 toward the bone anchor 10.

[0112] Figure 17 The threaded member 120 is shown adjacent to the outer sleeve 104, such that the threaded member 120 is in its most distal position and cannot advance distally. In this orientation, the spinal rod 16 is repositioned within the bone anchor 10.

[0113] Figure 18 and Figure 19 A fixing screw 140 is shown, which is inserted through a channel 142 in the inner sleeve 104 and screwed into the bone anchor receiver component using an inserter 1802. In some embodiments, such as Figure 19As shown, by applying a rotational force 1902, the inserter can be used to temporarily fasten the fixation screw to the bone anchor. The fixation screw 140 can be advanced distally through the inner sleeve 104, for example through the threaded member 120 and the translation member 122, to engage the spinal rod, thereby locking the spinal rod to the bone anchor. Furthermore, as... Figure 20 As indicated by the middle arrow 2002, a reverse rotation operation can be performed, or as... Figure 21 As indicated by the middle arrow 2102, a spreading operation can be performed using the inserter to introduce and drive the retaining screw 140 when it is positioned through the inner sleeve 104. In other embodiments, such counter-rotation and / or spreading operations can be performed using the instrument 100 without any inserter.

[0114] Given the forces involved, the final tightening of the retaining screw 140 may require the application of a counter-torque. Figure 22 An anti-torque device 146 is shown disposed on the outer sleeve 102. The anti-torque device 146 is connectable to a proximal flat portion 144 and a groove 145 on the outer sleeve 102 to form a shape-fit connection that prevents relative rotation between components. The proximal flat portion 144 may allow corresponding mating features 148 of the anti-torque device 146 to be spaced apart in a plurality of orientational connections (e.g., the flat portion may be formed in a hexagonal or other pattern around the circumference of the instrument to allow for various rotational orientations relative to the instrument). Figure 23 As shown, the drive 150 can be introduced through the inner sleeve 104 to engage the fixing screw, and fastening is performed by means of the anti-torque device 146 that locks the rod in the receiver member of the anchor.

[0115] Additionally, the modular counter-rotating sleeve or tube 152 can also be used to connect to the outer sleeve 102 of the instrument 100 and bypass the threaded inner sleeve. The flat portion of the direct engagement with the outer sleeve 102 allows for connection via... Figure 22 and Figure 23 The modular anti-torque device 146 of the same type shown applies anti-torque directly via the anti-rotation sleeve 152. This is in contrast to other devices that provide connection via an internally threaded sleeve component. Figure 24 A modular counter-rotating sleeve 152 connected to the device 100 is shown.

[0116] Figures 25 to 27 A counter-rotation sleeve 152, which can be attached to the outer sleeve 102, is shown in more detail. The counter-rotation sleeve 152 can be used to provide additional leverage when manipulating the vertebra or other bone to which the sleeve is attached. For example, the counter-rotation assembly 152 can facilitate the application of counter-rotation, distension, compression, or other forces to the vertebra or fixation structure, such as to correct a patient's spinal angle, deformity, or other condition. The counter-rotation sleeve can also provide attachment points for counter-rotation frames, navigation systems, or other surgical instruments.

[0117] The counter-rotating sleeve 152 may include a tubular shaft 154 having one or more articulated arms or leaf springs 156 for engaging with a resetter device 100 or other instrument to secure the counter-rotating sleeve 152 thereto. The counter-rotating sleeve 152 may include a locking ring 158 for selectively retaining engagement of the arms 156 with the resetter device 100 or other instrument. The sleeve 152 may include internal sidewalls defining an inner cavity or working channel 160 extending through the shaft. The locking ring 158 may be disposed around an outer surface of the sleeve 152 for axial movement relative to it. The locking ring 158 may be coupled to the sleeve 152 via one or more pins 162 inserted therethrough.

[0118] The articulated arm 156 can be configured to grip the drive interface of an instrument inserted therethrough. The articulated arm 156 is movable between an open configuration in which the instrument can be inserted into and removed from the counterspinning sleeve 152, and in the closed position in which the instrument can be captured or held within the counterspinning sleeve. A locking ring 158 can be positioned in an unlocked position and a locked position, in which the articulated arm 156 is free to move or pivot relative to the counterspinning sleeve 154, and in the locked position, the articulated arm 156 is constrained to be unable to move relative to the counterspinning sleeve 154. The articulated arm 156 is radially inward and / or radially outward pivoting relative to the longitudinal axis A1.

[0119] The articulated arm 156 may include a body 161 having a protrusion 164 at its distal end. The body 161 may be radially pivotable to introduce the protrusion 164 into a cavity 160 to grip an instrument or other object inserted therethrough. A locking ring 158 may slide axially over the articulated arm 156 to move the arm from an open configuration to a closed configuration, and / or to prevent movement of the arm 156 relative to the sleeve 152, thereby locking the arm in a closed configuration.

[0120] The counter-rotating sleeve 152 may include a distal drive port 166 configured to mate with a proximal flat portion on the outer sleeve 102. The drive port 166 may communicate with the inner cavity 503 such that a tool inserted through the drive port 166 can pass through at least a portion of the inner cavity 160, and a tool inserted through the inner cavity 160 can pass through at least a portion of the drive port 166. The drive port 166 and the inner cavity 160 may be separated by an abutment surface or shoulder 168 defined by the inner wall of the counter-rotating sleeve 152 to prevent instruments inserted into the drive port 166 from being advanced too proximally into the inner cavity 160.

[0121] The proximal end of the counter-rotating sleeve 152 may include a flat portion 172 similar to the flat portion formed on the outer sleeve 102, thereby allowing the same modular handle to be connected to both sub-assemblies and thus to apply counter-torque to both sub-assemblies via the same handle. In some embodiments, the length of the proximal end portion of the counter-rotating sleeve 152 including the flat portion 172 may be extended to provide a larger surface area for engagement by various instruments coupled thereto.

[0122] Figure 28 A counter-rotating sleeve 152 is shown, which is coupled to an outer sleeve 102 while bypassing a threaded member of an inner sleeve. For example, the counter-rotating sleeve 152 may include one or more engagement surfaces 170 positioned in a drive interface 166 or a cavity 160. As shown, engagement surfaces 170 may project from the inner surface of the counter-rotating sleeve 152 at various angles to engage a proximal flat portion 144 formed on the outer sleeve 102. In this way, the counter-rotating sleeve 152 forms a form-fit connection with the outer sleeve 102, while the threaded member 120 of the inner sleeve 104 remains disposed within a channel of the counter-rotating sleeve 152 without engaging with it. Therefore, the counter-rotating sleeve 152 can be held fixed relative to the outer sleeve 102, thereby enabling the application of a counter-rotating force on the vertebra without rotation relative to the vertebra. Figure 27 As shown, the abutting surfaces 170 can be positioned at approximately a 90-degree angle relative to each other to abut the flat portions, thereby facilitating connection and limiting the rotation of the counter-rotating sleeve 152 relative to the outer sleeve 102. However, in other embodiments, fewer or more abutting surfaces 170 may be used and spaced around the circumference of the sleeve 152, wherein the corresponding flat portions 144 are arranged around the circumference of the outer sleeve.

[0123] Figure 29 A cross-sectional view of the connection between the outer sleeve 102 and the counter-rotating sleeve 152 is shown. As described above, retention of the counter-rotating sleeve 152 is achieved via a locking ring 158 that restricts the hinge arm 156 engaging the circumferential groove 145 on the outer sleeve. As noted above, the proximal end of the counter-rotating sleeve 152 may include a flat portion 172 similar to the flat portion formed on the outer sleeve, thereby allowing the same modular handle to be connected to both sub-assemblies, and thus applying counter-torque to both sub-assemblies via the same handle. This can be seen, for example... Figure 30 as well as Figure 31 ,exist Figure 30 In, similar to Figure 22 and Figure 23 The modular anti-torque device 146 shown is depicted as being directly coupled to device 100, and in Figure 31 In the diagram, the anti-torque device 146 is shown connected to the modular anti-rotation sleeve 152, which in turn is connected to the device 100.

[0124] Figure 32 and Figure 33 Another embodiment of the resetter device 200 of this disclosure is shown. The resetter device 200 may be similar to the device described above in many respects; therefore, for the sake of brevity, a detailed description of each feature is omitted.

[0125] As shown in the figure, the reset device 200 may include an outer sleeve 202, an inner sleeve 204, and a pair of pivoting arms 206 attached to the outer sleeve 202. Figure 1 As with the embodiments discussed herein, the outer sleeve 202 may define a working channel 208 configured to receive at least a portion of another tool or instrument (e.g., the inner sleeve 204). The channel 208 provides access to the surgical site, allowing instruments or implants to pass through it. The channel 208 may extend from the proximal end 200p of the retractor instrument 200 to the distal end 200d of the retractor instrument. Pivot arms 206 may be disposed within opposing recesses 209 formed in the outer sleeve 202. The distal ends 206ad, 206bd of the pivot arms 206a, 206b and the protrusions 227 of the pivot arms 206a, 206b may enter the channel 208, as further described below. Including the recesses 209 allows the pivot arms 206a, 206b to be positioned closer to the body of the retractor instrument 200, thus narrowing the overall profile of the instrument and preventing the arms from interfering with body tissues, other surgical instruments, etc. Pin 210 can connect arm 206 to outer sleeve 202. In use, the reduction device 200 can be positioned such that pivot arms 206a, 206b engage with bone anchor 10 disposed between them to mate the reduction device 200 to the bone anchor 10, for example as... Figure 34 As shown, and discussed in more detail below.

[0126] Each pair of static or fixed arms 234a, 234b used for rod reduction may include a window 225 formed therein to allow observation of the fixation screw during tightening and loosening as it is screwed into the bone anchor. As shown, the window 225 may be shaped as a slit extending along the length of the static arms 234a, 234b to allow the fixation screw or another instrument to be visible as it travels through the reduction device 200 to engage the bone anchor. Figure 1 Compared to window 125, window 225 can extend further distally to allow for better visibility of the fixation screw once it has been tightened into the bone anchor. In some embodiments, the size of window 225 can vary based on the size of the inner sleeve 204 (e.g., its diameter, length, thickness, etc.). For example, as described above regarding... Figures 6 to 8 The size of the inner sleeve 204 discussed can vary, with each inner sleeve size having a corresponding window size. However, in some embodiments, windows of different sizes can be combined in various ways to form on inner sleeves of different sizes to provide maximum visibility of the fixing screws.

[0127] The outer sleeve 202 may include a generally tubular central portion terminating at a first extension or arm 212a and a second extension or arm 212b. The extensions 212a, 212b may include sidewalls 233 extending from the inner surface 232 at the lateral ends of each arm 212a, 212b. The sidewalls 233 may include a tapered profile to aid alignment with the receiver member of the bone anchor. The outer sleeve 202 has a distal recess 231 formed between opposing arms 212a, 212b, which receives and engages with the receiver member of the bone anchor 10.

[0128] Figure 34 A repositioning device 200 is shown that engages with the bone anchor 10 and repositions the spinal fixation rod 16. Arms 212a, 212b engage the bone anchor 10, and the spinal rod 16 is positioned laterally through the outer sleeve 202 between the arms 212a, 212b and distal to the static arms 234a, 234b of the inner sleeve 204, such that distal advancement of the inner sleeve 204 translates the static arms 234a, 234b distally into contact with the spinal rod 16. Further distal advancement causes the inner sleeve 204 to translate through the outer sleeve 202 to force the spinal rod distally toward the bone anchor until the spinal rod is repositioned into the rod seat of the receiver member of the bone anchor 10.

[0129] In some cases, for example, the repositioning device may undesirably detach from the bone anchor due to outward opening of arms 212a, 212b when subjected to certain load conditions during use. In some embodiments, the distal portions of arms 212a, 212b may have increased thickness, resulting in an increased outer diameter being carried further away from the distal ends of arms 212a, 212b. This increases the stiffness and strength of the arms, thereby helping to resist accidental arm opening and potential detachment from the bone anchor during use. Alternatively or additionally, sidewalls 233 extending from the inner surface 232 of each arm 212 may include one or more extensions 235 projecting inwardly into the channel 208 and the distal recess 231. Each extension 235 may form a notch 237 between the extension and the inner surface 232, and the notch may be configured to receive a portion of the bone anchor therein. Figure 35 An extension 235 is shown to be formed on the opposite side of each arm 212. The notch 237 provides multiple contact points between the arm 212 and the bone anchor that engages with it.

[0130] Figures 36 to 40 The interaction between the notch 237 and the bone anchor receiver component is shown during the attachment of the repositioning device 200 to the bone anchor. (See diagram.) Figure 36As shown in the detailed perspective view, the proximal portion of the bone anchor receiver member 240 can be received within a recess 237 formed between the inner surface 232 of the arm 212 and the extension 235. Because the opening force pushes the arm 212 radially outward relative to the bone anchor receiver member 240, the extension 235, which is radially inwardly disposed relative to one of the opposing arms 242 of the bone anchor receiver member, effectively resists any relative movement between the outer sleeve arm 212 and the receiver member 240. The bone anchor receiver member 240 may include one or more recesses 239 formed at the side ends of its opposing arms 242, which may be configured to receive the extension 235 without reducing the width of the rod slot opening between the opposing arms 242 of the receiver member 240. Figure 36 In the setup shown, the repositioning device 200 can withstand high loads in different directions, such as those occurring during spinal rod repositioning, without detaching from the bone anchor 10, because the extension 235 abuts against the sidewall of the corresponding bone anchor recess 239 to prevent the arm 212 from opening.

[0131] Figure 37 A side view of a repositioning device 200 coupled to the bone anchor 10 and repositioning the spinal fixation rod 16 is shown. As shown in the figure, the outer sleeve 202 includes a rod-catching opening 224 between arms 212a, 212b, which has a wider proximal portion and tapers to a narrower width distally. This configuration allows for larger tolerances to rotational and / or lateral misalignment of the rod and the repositioning device, which can be gradually corrected as the rod is axially repositioned toward the bone anchor. In some embodiments, the transition between the wider and narrower rod-catching opening widths can be gradual or smooth to prevent the rod from becoming constricted by more abrupt transitions (e.g., step-like or small-diameter arc transitions).

[0132] Figure 38 It shows along Figure 37 A sectional view of the repositioning device 200 and bone anchor 10, taken from line AA. Similar to... Figure 36 As can be seen, the extension 235 is disposed in a recess 239 formed in the lateral edge of the bone anchor receiver member 240, which in turn means that the opposing arm of the receiver member 240 is disposed in a recess 237 formed between the extension 235 and the inner surface 232 of the arm 212 (obscured in this view). This creates a stop, thereby allowing the extension 235 to resist forces that radially pull the arm 212 away from the receiver member 240 (into the plane of the page in this view).

[0133] Figure 39 It shows along Figure 37 A sectional view of the repositioning device 200 and bone anchor 10, taken from line BB. Similar to... Figure 36 and Figure 38The diagram illustrates the configuration of the extension 235 for creating a notch 237 between the inner surface 232 of the arm 212 and the extension itself. A portion of the bone anchor receiver member arm 242 disposed within the notch 237 is also shown, such that the extension 235 is resistant to any radially outward forces (left and right in the page plane in this view) that could threaten to detach the arm 212 from the opposing arm 242 of the receiver member. Finally, the figure also shows the extension 235 being received in a notch 239 formed in the opposing arm 242 of the receiver member 240, such that the width W of the rod slot is not reduced. This configuration is repeated at each lateral edge of each arm 212.

[0134] As mentioned above Figure 5 The distal translation member 222 discussed may include a first static or fixed arm 234a and a second static or fixed arm 234b extending distally therefrom for performing rod reduction. For example, as the inner sleeve 204 translates distally within the reducer device 200, arms 234a, 234b may contact and abut against the spinal rod to push it distally. Arm 234 may include distal contact surfaces 234s1, 234s2, which may be configured to abut and / or otherwise engage the spinal rod during reduction of the reducer device 200 to advance the spinal rod distally into the bone anchor 10. As shown, the translation member 222 may taper distally toward the generally flat distal contact surfaces 234s1, 234s2, such as... Figure 40 As shown. However, in some embodiments, other distal contact surface shapes may be utilized. For example, in some embodiments, the distal contact surfaces 234s1, 234s2 of arms 234a, 234b may be shaped to match the rod shape to which the inner sleeve 204 will be used. Figure 41 As shown, for example, arms 234a and 234b may include contact surfaces 234s1' and 234s2' (not shown in the side view of the figure), which are concave in shape and have a diameter commensurate with the diameter of the rod.

[0135] As mentioned above Figure 34 As noted, the translation member 222 can be configured to advance distally without rotation to advance the spindle rod into the receiver member 240. To prevent undesirable rotation of the inner sleeve 204 relative to the outer sleeve 202, a longitudinal groove 223 is formed within the translation member 222 (see [link to documentation]). Figure 40 It can mate with the cam-shaped semi-circular surface or protrusion 227 on the lower side of the lever fulcrum to prevent rotation of the translation member during reset, such as Figure 42 As shown. The protrusion 227 can extend from the surface of the arm 206 through the opening recess and straddle the longitudinal groove 223 to allow translation while preventing the translation member 222 from rotating relative to the outer sleeve 202.

[0136] Figures 43 to 45 An alternative embodiment of the resetter device 200' is shown. The resetter device 200' may include an alternative design with pivot arms 206a', 206b' without the protrusion 227. For example... Figure 44 As shown in the figure, the reset device 200' without the outer sleeve 202' is depicted, and the fulcrum 227' of the pivot arms 206a', 206b' is flat compared to the protrusion 227 of the reset device 100. Furthermore, as... Figure 45 As shown, the pivot arm 206' of the reset device 200' does not extend into the channel 223' of the inner sleeve 204'. To prevent rotation of the inner sleeve 204', the reset device 200' includes one or more pins 242' disposed in one or more holes formed in the outer sleeve 202', such that the pins extend into the channel 223' of the inner sleeve 204'. The one or more pins may be disposed proximal or distal to the fulcrum 227' at a position distal to the thread formed in the outer sleeve 202', such that they can be received within the groove 223' without interfering with the threaded connection between the outer sleeve and the inner sleeve 204'. More specifically, the one or more pins 242' may straddle a key or groove 223' formed in the translation member 222' of the inner sleeve 204', such as Figure 44 As shown, this is to prevent the translation member 222' from rotating relative to the outer sleeve 202'. In use, such as during the engagement of the repositioning device 200' with the bone anchor 10, the pivot arms 206a', 206b' may bend outward and inward as they pass over the receiver member 240 to engage a notch or other feature formed in the outer surface of the receiver member 240.

[0137] Figure 46An alternative embodiment of the inner sleeve 304 is shown. The inner sleeve 304 may include a threaded member 320, a translational member 322, and a washer 324, such as a thrust washer, which is separable and serves as a support surface between the translational member 322 and the threaded member 320. As shown, the inner sleeve 304 may include an integral handle 326 at the proximal end of the threaded member 320. The handle 326 may be integrally formed with the threaded member 320 to provide a monolithic structure. The handle 326 may be configured to be gripped by a user to rotate the threaded member 320. In this way, the integral handle 326 may be an alternative to the modular drive features (e.g., flat portion, hexagonal drive feature, etc.) of the resetter instruments 100, 200 to allow direct manipulation of the inner sleeve without the need for any additional instruments. As noted above, any of the various handle configurations or other structures may be coupled to the threaded member in any of a variety of modular or permanent ways. These may include the use of modular connection features such as hexagonal drive feature 402, integrally formed structures such as integral handle 326 and threaded member 320, and other connection methods such as connecting components with fixing screws or other mechanical fasteners, adhesive components, welded components, etc.

[0138] Additionally, the handle 326 may include a cavity 328 extending therethrough to allow the insertion of a fixation screw or other instrument into the bone anchor coupled to the reduction device. The cavity 328 may extend through the integral handle 326 and threaded member 320. In embodiments using a modular handle, a cavity may also be included that, when coupled to the threaded member, aligns with the cavity of the threaded member to allow the insertion of a fixation screw or other instrument through it. Therefore, the above (e.g., in conjunction with...) Figures 18 to 21 The method described herein can be used in implementations including both modularly coupled handles and integrally formed and / or permanently coupled handles.

[0139] The instruments disclosed herein can be constructed from any of a variety of known materials. Exemplary materials include those suitable for 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. Furthermore, a variety of manufacturing methods can be utilized, including 3D printing or other additive manufacturing technologies, as well as more conventional manufacturing techniques, including molding, stamping, casting, machining, etc.

[0140] The devices and methods disclosed herein can be used in minimally invasive and / or open surgical procedures. Although the devices and methods disclosed herein are generally described in the context of surgery on human patients, it should be understood that the methods and devices disclosed herein can be used in any of a variety of surgical procedures in any human or animal subject, or in non-surgical procedures.

[0141] The device disclosed herein may be designed for single-use disposal or for multiple-use applications. However, in either case, the device can be repaired and reused after at least one use. Repair may include any combination of the following steps: disassembly, subsequent cleaning or replacement of specific parts, and subsequent reassembly. Specifically, the device or component may be disassembled, and any number of specific parts or components may be selectively replaced or removed in any combination. During cleaning and / or replacement of specific parts, the device or component may be reassembled by the surgical team at the repair facility or directly prior to surgical procedures for subsequent use. Repair of the device or component can be performed using a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting repaired device are within the scope of this application.

[0142] The device described herein can be processed prior to its use in surgical procedures. For example, new or used instruments or components may be obtained and cleaned as needed. The instruments or components may be sterilized. In one sterilization technique, the instrument or component may be placed in a closed and sealed container (such as a plastic bag or a TYVEK bag). The container and its contents may then be placed in a radiation field that can penetrate the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation kills bacteria on the instrument or component and in the container. The sterilized instrument or component may then be stored in a sterile container. The sealed container keeps the instrument or component sterile until it is opened in a medical facility. Other forms of sterilization are also possible, including beta radiation or other forms of radiation, ethylene oxide, steam, or liquid baths (e.g., cold immersion). Due to factors such as the materials used and the presence of electronic components, certain forms of sterilization may be more suitable for use in conjunction with different parts of the device.

[0143] In this disclosure, phrases such as “at least one of…” or “one or more of…” may appear after a list of connected 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 a phrase is intended to mean any of the individually listed elements or features or any of the listed elements or features in combination with any of the 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 applies to lists comprising 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 “A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together.” Furthermore, the use of the term "based on" is intended to mean "at least partially based on," making unlisted features or elements permissible as well.

[0144] Further features and advantages based on the above embodiments are possible and fall within the scope of this disclosure. Therefore, this disclosure is not limited to what has been specifically shown and described. All applications and references cited herein are incorporated by full reference unless any definition, subject matter waives or denies the claims, and unless the incorporated material is inconsistent with the expression disclosed herein, in which case the language of this disclosure shall prevail.

[0145] Examples of the above implementation scheme may include the following:

[0146] 1. A surgical instrument, comprising:

[0147] An outer sleeve having an inner channel defined therein, the outer sleeve terminating at a pair of extensions at its distal end;

[0148] Inner sleeve, the inner sleeve having a proximal threaded portion and a distal translational portion and configured to pass through the outer sleeve; and

[0149] A pair of pivot arms, the pair of pivot arms being received in the extension within the outer sleeve, the pivot arms being configured to extend into the channel to engage the bone anchor to the outer sleeve;

[0150] The proximal end portion of the outer sleeve includes one or more flat portions configured to engage with another instrument.

[0151] 2. The device of claim 1, wherein the pivot arm is spring-loaded to be biased to a closed position.

[0152] 3. The apparatus according to any one of claims 1 to 2, wherein the threaded portion comprises a first threaded portion and a second threaded portion separated from the non-threaded portion.

[0153] 4. The device according to any one of claims 1 to 3, wherein the threaded portion is configured to be pulled and rotated to be removed from the outer sleeve.

[0154] 5. The device according to any one of claims 1 to 4, wherein the proximal end portion of the outer sleeve includes a circumferential groove.

[0155] 6. The device according to any one of claims 1 to 5, wherein the pair of pivot arms further includes a protrusion extending into one or more longitudinal grooves in the distal translational portion of the inner sleeve to prevent the distal translational portion from rotating relative to the outer sleeve.

[0156] 7. The device according to any one of claims 1 to 5, further comprising a pin extending into one or more longitudinal grooves in the distal translational portion of the inner sleeve to prevent rotation of the distal translational portion.

[0157] 8. The apparatus according to any one of claims 1 to 7 further includes an anti-torque device having a mating feature corresponding to one or more flat portions on the outer sleeve.

[0158] 9. The device according to any one of claims 1 to 8, further comprising a counter-rotating sleeve defining an inner cavity therethrough, the counter-rotating sleeve being configured to be coupled to the outer sleeve, the counter-rotating sleeve having one or more engagement surfaces that overlap with the one or more flat portions for coupling.

[0159] 10. The apparatus of claim 9, wherein the counter-rotating sleeve further comprises a pair of hinged arms configured to extend into the inner cavity to further connect the counter-rotating sleeve to the outer sleeve.

[0160] 11. The apparatus of claim 10, wherein the counter-rotating sleeve further comprises a locking ring configured to selectively restrict movement of the articulated arm.

[0161] 12. The apparatus of claim 10, wherein the articulated arm is received in a circumferential groove along the outer sleeve.

[0162] 13. A surgical instrument comprising:

[0163] The housing has a central opening, a proximal end, a distal end, and a central longitudinal axis (A1) extending between the proximal end and the distal end.

[0164] A first fixing arm and a second fixing arm extending distally from the outer casing;

[0165] A first pivot arm and a second pivot arm movably coupled to the housing, each pivot arm having a proximal end and a distal end, the pivot arms being configured to selectively retain the bone anchor between them; and

[0166] A reset shaft, which is threadedly mounted in the central opening of the housing;

[0167] Each of the first arm and the second arm extending distally from the housing defines an inner surface, and each of the first arm and the second arm includes a sidewall extending outwardly from the inner surface at a lateral end of each arm.

[0168] 14. The device of claim 13, wherein the inner surface of each of the first arm and the second arm has a tapered profile.

[0169] 15. The device according to any one of claims 13 to 14, wherein the opposing inward-facing surfaces of each sidewall of the arm have a planar tapered profile.

[0170] 16. The device according to any one of claims 13 to 15, wherein the pivot arm is mounted in a recess formed in the fixed arm.

[0171] 17. The device according to any one of claims 13 to 16, wherein the pivot arm is pivotally connected to the housing at a position between the proximal end and the distal end of the pivot arm.

[0172] 18. The device according to any one of claims 13 to 17, wherein the reset shaft includes a first portion having an external thread and configured to rotate relative to the housing to advance the reset shaft distally relative to the housing.

[0173] 19. The device of claim 18, wherein the reset shaft includes a second portion rotatably fixed relative to the housing, the second portion including a distally facing rod engagement surface.

[0174] 20. The device of claim 19, wherein the first portion includes one or more inwardly facing protrusions received in a circumferential groove formed in the outer surface of the second portion.

[0175] 21. The apparatus according to any one of claims 13 to 20, wherein the reset shaft defines a working channel extending therethrough.

[0176] 22. The apparatus according to any one of claims 13 to 21, wherein the distal end portion of the reset shaft includes a visualization window formed therein.

[0177] 23. The apparatus according to any one of claims 13 to 21, wherein the reset shaft includes a drive interface at the proximal end of the reset shaft.

[0178] 24. The device according to any one of claims 13 to 21, wherein the reset shaft includes a handle at its proximal end, the handle being configured to be gripped by a user.

[0179] 25. The apparatus according to any one of claims 13 to 23, further comprising a counter-rotating shaft selectively attached to the reset shaft.

[0180] 26. The apparatus of claim 25, wherein the counterrotating shaft includes an elongated body defining a working channel extending therethrough, the working channel of the counterrotating shaft communicating with the working channel of the reset shaft and the central opening of the housing.

[0181] 27. The apparatus of claim 25, wherein the counter-rotating shaft comprises opposing hinge arms and a locking ring, wherein the locking ring is movable between a locked position and an unlocked position, wherein in the locked position the locking ring holds the hinge arm in a radially inward position, wherein the hinge arm engages a groove formed in the housing, and in the unlocked position the hinge arm is movable radially outward to disengage from the groove in the housing.

[0182] 28. The apparatus of claim 25, wherein the counterrotating shaft includes a drive interface at the proximal end of the counterrotating shaft.

[0183] 29. The device according to any one of claims 13 to 28, wherein the sidewall includes an extension that forms a notch between each extension and the inner surface.

[0184] 30. The device of claim 29, wherein the notch is configured to receive part of a bone anchor.

[0185] 31. The device according to any one of claims 13 to 30, wherein the reductor shaft includes a generally flat distal surface configured to engage the spinal rod.

[0186] 32. The device according to any one of claims 13 to 30, wherein the reductor shaft includes a recessed distal surface configured to engage the spinal rod.

Claims

1. A surgical instrument, comprising: An outer sleeve having an inner channel defined therein, the outer sleeve terminating at a pair of extensions at its distal end; An inner sleeve having a proximal threaded portion and a distal translational portion and configured to pass through the outer sleeve; as well as A pair of pivot arms, the pair of pivot arms being received in the extension within the outer sleeve, the pivot arms being configured to extend into the channel to engage the bone anchor to the outer sleeve; The pair of pivot arms further includes a protrusion that extends into one or more longitudinal grooves in the distal translational portion of the inner sleeve to prevent the distal translational portion from rotating relative to the outer sleeve.

2. The device according to claim 1, wherein, The pivot arm is spring-loaded to be biased to the closed position.

3. The device according to claim 1, wherein, The threaded portion includes a first threaded portion and a second threaded portion separated from the non-threaded portion.

4. The device according to claim 1, wherein, The threaded portion is configured to be pulled and rotated to be removed from the outer sleeve.

5. The apparatus according to claim 1, wherein, The proximal end portion of the outer sleeve includes a circumferential groove.

6. The device of claim 1, further comprising a pin extending into one or more longitudinal grooves in the distal translational portion of the inner sleeve to prevent rotation of the distal translational portion.

7. The device according to claim 1 further includes an anti-torque device having a mating feature corresponding to one or more flat portions on the outer sleeve.

8. The device of claim 1, further comprising a counter-rotating sleeve defining an inner cavity therethrough, the counter-rotating sleeve being configured to be coupled to the outer sleeve, the counter-rotating sleeve having one or more engagement surfaces that overlap with the one or more flat portions for coupling.

9. The apparatus according to claim 8, wherein, The counter-rotating sleeve also includes a pair of hinged arms configured to extend into the inner cavity to further connect the counter-rotating sleeve to the outer sleeve.

10. The apparatus according to claim 9, wherein, The counter-rotating sleeve also includes a locking ring configured to selectively restrict the movement of the articulated arm.

11. The apparatus according to claim 9, wherein, The hinge arm is received in a circumferential groove along the outer sleeve.

12. A surgical instrument comprising: The housing has a central opening, a proximal end, a distal end, and a central longitudinal axis (A1) extending between the proximal end and the distal end. A first fixing arm and a second fixing arm extending distally from the outer casing; A first pivot arm and a second pivot arm are movably coupled to the housing, each of the first pivot arm and the second pivot arm having a proximal end and a distal end, and at least one of the first pivot arm and the second pivot arm is configured to selectively retain the bone anchor between them; as well as A reset shaft, which is threadedly mounted in the central opening of the housing; Each of the first and second fixing arms, extending distally from the housing, defines an inner surface, and each of the first and second fixing arms includes a sidewall extending outwardly from the inner surface at a side end of each fixing arm; and At least one of the first and second pivot arms further includes a protrusion that extends into one or more longitudinal grooves of the reset shaft to prevent the distal translational portion of the reset shaft from rotating relative to the housing.

13. The apparatus according to claim 12, wherein, The inner surface of each of the first and second fixed arms has a tapered profile.

14. The apparatus according to claim 12, wherein, The opposing inward-facing surfaces of each sidewall of each of the first and second fixed arms have a planar tapered profile.

15. The apparatus according to claim 12, wherein, At least one of the first pivot arm and the second pivot arm is mounted in a recess formed in at least one of the first fixed arm and the second fixed arm.

16. The apparatus according to claim 12, wherein, At least one of the first and second pivot arms is pivotally connected to the housing at a midpoint between the proximal and distal ends of the at least one pivot arm.

17. The apparatus according to claim 12, wherein, The reset shaft includes a first portion having an external thread and configured to rotate relative to the housing to advance the reset shaft distally relative to the housing.

18. The apparatus according to claim 17, wherein, The resetter shaft includes a second portion that is rotatably fixed relative to the housing, the second portion including a rod engagement surface facing the distal side.

19. The apparatus according to claim 18, wherein, The first portion includes one or more inwardly facing protrusions received in a circumferential groove formed in the outer surface of the second portion.

20. The apparatus according to claim 12, wherein, The resetter shaft defines a working channel that extends through it.

21. The apparatus according to claim 12, wherein, The distal end portion of the resetter shaft includes a visualization window formed therein.

22. The apparatus according to claim 12, wherein, The reset shaft includes a drive interface at its proximal end.

23. The apparatus according to claim 12, wherein, The reset shaft includes a handle at its proximal end, the handle being configured for a user to grip.

24. The apparatus of claim 12, further comprising a counter-rotating shaft attached to the reset shaft.

25. The apparatus according to claim 24, wherein, The counter-rotating shaft includes an elongated body defining a working channel extending therethrough, the working channel of the counter-rotating shaft communicating with the working channel of the reset shaft and the central opening of the housing.

26. The apparatus according to claim 24, wherein, The counter-rotating shaft includes opposing hinge arms and a locking ring, wherein the locking ring is movable between a locked position and an unlocked position, in which the locking ring holds the hinge arm in a radially inward position, in which the hinge arm engages a groove formed in the housing, and in the unlocked position, the hinge arm is movable radially outward to disengage from the groove in the housing.

27. The apparatus according to claim 24, wherein, The anti-rotation shaft includes a drive interface at its proximal end.

28. The apparatus according to claim 12, wherein, The sidewall includes an extension, which forms a notch between each extension and the inner surface.

29. The apparatus according to claim 28, wherein, The notch is configured to be part of a bone anchor.

30. The apparatus according to claim 12, wherein, The resetting shaft includes a generally flat distal surface configured to engage the spinal rod.

31. The apparatus according to claim 12, wherein, The resetting shaft includes a recessed distal surface configured to engage the spinal rod.

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