CN117460482A

CN117460482A - Expandable interbody implant and corresponding surgical tool

Info

Publication number: CN117460482A
Application number: CN202280042435.5A
Authority: CN
Inventors: S·K·海耶斯; R·M·洛克; C·J·巴菲尔德; D·K·普罗托普索帝斯
Original assignee: Warsaw Orthopedic Inc
Current assignee: Warsaw Orthopedic Inc
Priority date: 2021-06-24
Filing date: 2022-05-04
Publication date: 2024-01-26

Abstract

An interbody system is disclosed that includes an implant and a tool for inserting and expanding a medical implant and locking the implant in place. The medical implant may include an expandable body defined by hingedly coupled upper and lower end plates, and may be expandable and lordotic. The upper and lower end plates may include radially disposed and opposed surfaces that mate and/or directly contact each other as the locking screw threads through the screw hole. For example, the implant may include a threaded break screw disposed in the threaded screw hole and movable between a locked position and an unlocked position. In the locked position, the threaded locking screw may urge the distal engagement surface of the first core into direct contact with the proximal engagement surface of the second core. When broken, the break screw may include a recessed breaking surface.

Description

Expandable interbody implant and corresponding surgical tool

Cross Reference to Related Applications

This application is a continuation-in-part application of the following patent applications: U.S. patent application Ser. No. 17/736,523, entitled "Expandable interbody implant and corresponding surgical tool (EXPANDABLE INTERBODY IMPLANT AND CORRESPONDING SURGICAL TOOL)" filed on 5/4 of 2022; U.S. patent application Ser. No. 17/665,449, entitled "Expandable implant and corresponding insert (EXPANDABLE IMPLANT AND CORRESPONDING INSERTER)" filed on 4/2/2022; U.S. patent application Ser. No. 17/515,709, entitled "Expandable implant and corresponding insert (EXPANDABLE IMPLANT AND CORRESPONDING INSERTER)" filed on 1, 11, 2021; and U.S. patent application Ser. No. 17/356,950, entitled "Expandable interbody implant (EXPANDABLE INTERBODY IMPLANT)" filed on 24, 6, 2021, the entire disclosure of each of which is incorporated herein by reference. The present application also incorporates by reference the following patent applications: U.S. application Ser. No. 17/307,578 entitled "externally driven inflatable interbody and related METHODS (EXTERNALLY DRIVEN EXPANDABLE INTERBODY AND RELATED METHODS)", filed 5/2021; U.S. patent No. 11,096,796, entitled "INTERBODY spinal implant with rough surface topography on one or more interior surfaces (internet SPINAL IMPLANT HAVING A ROUGHENED SURFACE TOPOGRAPHY ON ONE OR MORE INTERNAL SURFACES)" filed on 3/4/2013; and U.S. patent No. 10,821,000, entitled "no alpha cases and enhanced osteoinductive titanium implant surface (TITANIUM IMPLANT SURFACES FREE FROM ALPHA CASE AND WITH ENHANCED ostenoiduction)" filed on month 6 and 29 of 2017.

Technical Field

In one aspect, the present technology relates generally to an externally driven expandable interbody implant for use in a medical procedure associated with the spinal column. In some embodiments, the disclosed implants may be used in an Anterior Cervical Discectomy (ACDF) procedure, but other uses in other areas of the spine or between two bones are also contemplated.

Background

Mechanically operated interbody implants may be used for alignment and/or realignment of a patient's spine during medical procedures and/or for purposes of fusion, denatured tissue, and/or trauma/repair procedures. Conventional implants designed for the thoracic and lumbar regions of the spine typically include top and bottom end plates and a mechanical device for separating the top and bottom end plates. The mechanical mechanisms for separating the top and bottom end plates are often cumbersome and require a large footprint, which is often not suitable for ACDF-type surgical procedures such as spinal necks. Many currently available ACDF-type implants may be limited in their ability to optimize the anterior or sagittal alignment of the vertebral bodies, as these implants may rely on a fixed anterior angle between the superior/cephalad and inferior/caudal sides of the device.

Disclosure of Invention

The technology of the present disclosure generally relates to an expandable interbody implant that includes upper and lower endplates hingedly coupled and may further include a locking element for securing the lower and upper endplates, for example, in a particular configuration. The upper and lower end plates may be moved in a largely expanded and/or forwardly or rearwardly convex or otherwise angled configuration via, for example, an external insert. In various embodiments, the locking screw may be a break-away screw. In various embodiments, at least one break-off tang on the implant can be used to clamp the implant for insertion into the intervertebral space, and then the break-off tang can be broken off and removed. Additionally, in various embodiments, a locking screw may be used to clamp and insert the implant into the intervertebral space. Additionally, in various embodiments, a concave recess rather than a tang (or convex boss/protrusion) may be used to clamp the implant and insert the implant into the intervertebral space.

In one aspect, the present disclosure provides an expandable implant that is movable, for example, between a contracted position (closed position) and an expanded position. For example, the expandable implant may include an expandable body that extends, for example, from a proximal end to a distal end in a proximal-to-distal direction (also may be referred to as an anterior-to-posterior direction depending on the surgical technique), from a first lateral side to a second lateral side in a width direction, and from an upper endplate to a lower endplate in a height direction (also may be referred to as a cephalad-to-caudal and/or vertical direction depending on the surgical technique). In various embodiments, the inflatable body may be defined, for example, by upper and lower end plates that are hingedly connected. In various embodiments, for example, the upper end plate includes a first core having a distal engagement surface (also may be referred to as a posterior engagement surface, depending on the surgical technique), and the lower end plate includes a second core having a proximal engagement surface (also may be referred to as an anterior engagement surface) and a threaded screw hole. In various embodiments, the disclosed implants may include a break-off screw having a break surface disposed in the threaded screw hole and movable, for example, between a locked position and an unlocked position. In various embodiments, the break screw, for example, pushes the distal engagement surface of the first core into direct contact with the proximal engagement surface of the second core when in the locked position.

In another aspect, the present disclosure provides a system, for example, comprising a medical implant and a surgical tool. The system may include, for example, an expandable implant that is movable between a contracted position and an expanded position. In various embodiments, the expanded position may also refer to a dispersed and angled orientation of the upper and lower end plates. The expandable implant may comprise an expandable body extending, for example, in a proximal-to-distal direction from a proximal end to a distal end and in a width direction from a first lateral side to a second lateral side. In various embodiments, the inflatable body may be defined, for example, by upper and lower end plates that are hingedly connected. In various embodiments, for example, the upper end plate includes a first core having a distal engagement surface and the lower end plate includes a second core having a proximal engagement surface and a threaded screw hole. In various embodiments, the disclosed implants can include a locking screw disposed in the threaded screw hole and movable, for example, between a locked position and an unlocked position. In various embodiments, the locking screw, for example, urges the distal engagement surface of the first core into direct contact with the proximal engagement surface of the second core when in the locked position. The system may also include a surgical tool for expanding the implant and tightening the locking screw when the implant is expanded at a desired height, position and/or angle.

In one aspect, an expandable implant is disclosed that is movable between a contracted position and an expanded position. The inflatable body may extend in a proximal to distal direction from a proximal end to a distal end and in a width direction from a first lateral side to a second lateral side, the inflatable body being defined, for example, by hingedly connected upper and lower end plates.

In various embodiments, the upper end plate includes, for example, a first core having a screw channel and a distal engagement surface. In various embodiments, the lower endplate includes, for example, a second core having a proximal engagement surface. The implant may include a locking screw, for example, that may extend through the first core and the second core and may be movable between a locked position and an unlocked position. In some embodiments, in the locked position, the locking screw urges the distal engagement surface of the first core against the proximal engagement surface of the second core.

In another aspect, the upper end plate includes a first clamping recess at a proximal end thereof; and the lower end plate for example comprises a second clamping recess at its proximal end.

In another aspect, the first clamping recess includes a groove having an upper curved surface and a lower curved surface; and the second clamping recess comprises, for example, a groove having an upper curved surface and a lower curved surface.

In another aspect, the upper endplate includes a first plurality of engagement features that are angled from about 20 degrees to about 40 degrees relative to a proximal surface of the upper endplate; and the lower endplate includes a second plurality of engagement features that are, for example, at an angle of about 20 degrees to about 40 degrees relative to a proximal surface of the lower endplate.

In another aspect, the upper endplate further includes a channel located near the distal end and extending in the width direction; and the lower end plate further includes, for example, a rail located near the distal end and extending in the width direction. In various embodiments, the track has, for example, a size and shape that generally corresponds to the size and shape of the channel and is located within the channel.

In various embodiments, the distal engagement surface of the first core comprises a first curved surface; the second core portion and the proximal engagement surface comprise a second curved surface; and the first curved surface is defined, for example, by the radius of a circle having a center point offset from the axis of rotation of the track.

In various embodiments, the upper end plate includes at least one hook adjacent the channel; the lower end plate including at least one relief adjacent the rail; the at least one hook portion has a size and shape that generally corresponds to the size and shape of the at least one release portion; and the at least one hook portion is for example provided within the at least one release portion.

In various embodiments, in a cross-sectional view, for example, the channel comprises an arcuate shape and the track comprises an arcuate shape.

In various embodiments, the locking screw includes a threaded end and a drive feature separated by a fracture surface for separating the locking screw; the first core is disposed proximally relative to the second core; and the locking screw may be, for example, threadably engaged with at least one of the first core and the second core.

In various embodiments, the locking screw extends in a proximal-to-distal direction along a longitudinal axis and is breakable into a proximal portion and a distal portion at a fracture surface; and when broken, the breaking surface is recessed, for example, with respect to the side wall of the locking screw.

In another aspect, a system including a medical implant and a surgical tool is disclosed. The system may include, for example, an expandable implant that is movable between a contracted position and an expanded position. In various embodiments, the inflatable body extends from a proximal end to a distal end in a proximal-to-distal direction and from a first lateral side to a second lateral side in a width direction, the inflatable body being defined, for example, by hingedly connected upper and lower end plates. In various embodiments, the upper endplate includes a first core having a screw channel and a distal engagement surface; and the lower endplate includes, for example, a second core having a proximal engagement surface. In various embodiments, the locking screw may be movable, for example, between a locked position and an unlocked position. In some embodiments, in the locked position, the locking screw urges the distal engagement surface of the first core against the proximal engagement surface of the second core, for example. In various embodiments, the system may include a surgical tool, for example, for moving the implant from a contracted position to an expanded position and for moving the locking screw between the locked position and the unlocked position. In some embodiments, the surgical tool may be configured to move the locking screw into the locked position while supporting the implant in the expanded position.

In various embodiments, the upper end plate includes a first clamping recess at a proximal end thereof; and the lower end plate for example comprises a second clamping recess at its proximal end. In some embodiments, the surgical tool includes a first clamping protrusion having a size and shape that generally corresponds to the size and shape of the first clamping recess; and the surgical tool includes a second clamping projection having, for example, a size and shape that generally corresponds to the size and shape of the second clamping recess.

In various embodiments, the first clamping recess includes a groove having an upper curved surface and a lower curved surface; and the second clamping recess comprises, for example, a groove having an upper curved surface and a lower curved surface.

In various embodiments, the surgical tool includes a pivot link assembly including, for example, a first arm and a second arm.

In various embodiments, the surgical tool includes a body portion, a handle, and a third arm, for example, fixed relative to the body portion.

In various embodiments, the surgical tool further comprises: a body portion having a bore extending therethrough; a pivot link assembly including a first arm and a second arm; and a third arm, for example fixed relative to the body portion. In some embodiments, an outer shaft may extend through the body portion and have a drive feature at a distal end thereof for rotating the locking screw from the unlocked position to the locked position; and an inner shaft may extend through the outer shaft and have a first thread pattern at an end thereof, for example, for pulling the expandable implant toward the surgical tool.

In various embodiments, the locking screw includes a recessed fracture surface for separating the locking screw into a proximal portion and a distal portion, and the surgical tool is configured, for example, to separate the locking screw into the proximal portion and the distal portion when the implant is in the expanded position, and to retain the proximal portion of the locking screw via the inner shaft.

In various embodiments, the surgical tool further comprises an actuator, for example, for pivoting the pivot link assembly relative to the third arm, thereby expanding the implant.

In various embodiments, the upper endplate further includes a channel located near the distal end and extending in the width direction; and the lower endplate further includes a rail located near the distal end and extending in the width direction, the rail having, for example, a size and shape generally corresponding to a size and shape of the channel and being located within the channel.

The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the technology described in this disclosure will be apparent from the description and drawings, and from the claims.

Drawings

Fig. 1 is a perspective view of an expandable implant.

Fig. 2 is an alternative perspective view of an expandable implant.

Fig. 3 is a top-down view of the expandable implant.

Fig. 4 is a side view of an expandable implant.

Fig. 5 is a rear perspective view of the expandable implant.

Fig. 6 is a perspective view of the interior of the superior endplate of the expandable implant.

Fig. 7 is a perspective view of the interior of the lower endplate of the expandable implant.

Fig. 8 is a perspective exploded partial view of the expandable implant.

Fig. 9 is an exploded partial view of the expandable implant from a side view perspective.

Fig. 10 is a perspective cross-sectional view of an expandable implant.

Fig. 11 is a cross-sectional view of an expandable implant.

Fig. 12 is a side view of an upper endplate for use with at least some of the expandable implant embodiments.

Fig. 13A is a perspective view of a first expandable implant.

Fig. 13B is a perspective view of a second expandable implant.

Fig. 14A is a perspective view of a third expandable implant.

Fig. 14B is a perspective view of a fourth expandable implant.

Fig. 15 is a perspective view of a fifth expandable implant.

Fig. 16 is a side view of the expandable implant in an expanded configuration.

Fig. 17 is a side view of an expandable implant showing the trajectory of a bone screw.

Fig. 18 is a front view of an expandable implant.

Fig. 19 is a front view of the enlarged area of fig. 18.

Fig. 20 is a perspective view of an insert for use with the disclosed expandable implant.

Fig. 21 is a perspective view of an insert for use with the disclosed expandable implant, the insert being shown in a skeleton outline for ease of understanding.

Fig. 22 is a perspective view of an insert for use with the disclosed expandable implant, the insert being shown in a skeleton outline for ease of understanding.

Fig. 23A is a rear view of the insert in a non-expanded position.

Fig. 23B is a rear view of the insert in the expanded position.

Fig. 24 is an enlarged view of a distal end of an insert in an expanded position coupled to an example expandable implant in a corresponding expanded position.

Fig. 25 is a perspective view of the expandable implant in an expanded configuration after the broken portion of the locking screw has been broken.

Fig. 26 is a perspective view of a surgical instrument for use with the disclosed expandable implant.

FIG. 27 is a perspective view of a surgical instrument for use with the disclosed expandable implant.

Fig. 28 is a perspective view of the expandable implant after the mounting tang has been broken.

Fig. 29 is a reference diagram showing a human spinal column in which various disclosed implant embodiments may be installed.

Fig. 30 is a reference view of various planes and reference directions in which the various implant embodiments disclosed may move or function relative to a patient.

Fig. 31 is a perspective view of a second implant embodiment.

Fig. 32 is a first perspective exploded partial view of a second implant embodiment.

Fig. 33 is a second perspective exploded partial view of a second implant embodiment.

Fig. 34 is a side exploded partial view of a second implant embodiment.

Fig. 35 is a first side view of a break screw having a recessed fracture surface.

Fig. 36 is a second side view of a break screw having a recessed fracture surface.

Fig. 37 is a cross-sectional view of a break screw with a recessed fracture surface.

Fig. 38 is a perspective view of a swage mount.

FIG. 39 is a cross-sectional view of the swage spindle and distal end of the break screw prior to the start of the swaging process.

Fig. 40 is a cross-sectional view showing the result of the swaging process.

Fig. 41 is an enlarged view of the region S-W of fig. 40.

Fig. 42A is a front perspective view of a third implant embodiment.

Fig. 42B is an alternative front perspective view of a third implant embodiment.

Fig. 43A is a front perspective view of an implant with angled engagement features.

Fig. 43B is a top-down view of an implant with angled engagement features.

Fig. 44 is a perspective view of a surgical tool for use with the disclosed implant embodiments.

Fig. 45 is a first side view of a surgical tool for use with the disclosed implant embodiments.

Fig. 46A is a second side view of a surgical tool for use with the disclosed implant embodiments.

Fig. 46B is a third side view of a surgical tool in an operative position for use with the disclosed implant embodiments.

Fig. 46C is a perspective view of the surgical tool in an operative position.

Fig. 47A is a first exploded partial view of a surgical tool for use with the disclosed implant embodiments.

Fig. 47B is a second exploded partial view of a surgical tool for use with the disclosed implant embodiments.

Fig. 48 is a perspective view showing the surgical tool just prior to coupling with the surgical implant.

Fig. 49 is a first cross-sectional view of the surgical tool and implant in a coupled configuration.

Fig. 50 is a second cross-sectional view of the surgical tool and implant in a coupled configuration.

Fig. 51 is a third cross-sectional view of the surgical tool and implant in a coupled configuration.

Fig. 52 is a perspective view of an expandable implant.

Fig. 53 is an alternative perspective view of an expandable implant.

Fig. 54 is a top-down view of an expandable implant.

Fig. 55 is a perspective exploded partial view of an expandable implant.

Fig. 56 is an alternative perspective exploded partial view of an expandable implant.

Fig. 57 is a side view of the upper end plate.

Fig. 58 is a side view of the expandable implant in a contracted position.

Fig. 59 is a side view of the expandable implant in an expanded position.

Fig. 60 is a rear view of the expandable implant.

Fig. 61 is a front view of an expandable implant with locking screw.

Fig. 62 is an exploded partial view of the upper end plate, lower end plate, and core partially rotated to view the various engagement surfaces.

Fig. 63 is a reference diagram showing a human spinal column in which various disclosed implant embodiments may be installed.

Fig. 64 is a reference view of various planes and reference directions in which the various implant embodiments disclosed may move or function relative to a patient.

Detailed Description

Embodiments of the present disclosure relate generally to spinal stabilization systems, for example, and more particularly to surgical instruments for use with spinal stabilization systems. Embodiments of the apparatus and method are described below with reference to the drawings.

The following discussion omits or only briefly describes certain components, features, and functions associated with medical implants, installation tools, and related surgical techniques, as would be apparent to one of ordinary skill in the art. It should be noted that various embodiments are described in detail with reference to the drawings, wherein like reference numerals designate like parts and assemblies throughout the several views, as possible. References to various embodiments do not limit the scope of the claims appended hereto, as these embodiments are examples of the inventive concepts described herein. Furthermore, any examples set forth in this specification are intended to be non-limiting and merely set forth some of the many possible embodiments for the appended claims. Moreover, unless the context or other statement clearly indicates otherwise, the particular features described herein may be used in combination with other described features in each of the various possible combinations and permutations.

As used herein, the terms "identical," "equivalent," "planar," "coplanar," "parallel," "perpendicular," and the like are intended to cover identical meanings, as well as to include variations that may occur, for example, due to manufacturing processes. The term "substantially" may be used herein to emphasize such a meaning, especially when the described embodiments have the same or nearly the same function or characteristics, unless the context or other statement clearly indicates otherwise.

Referring generally to fig. 1-43, various embodiments and views of an expandable implant 100 are disclosed. The components of the expandable implant 100 may be made of a biologically acceptable material suitable for medical applications, including metals, synthetic polymers, ceramics, and bone materials, and/or composites thereof. For example, these components may be made of the following materials, individually or collectively: such as stainless steel alloys, commercially pure titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, superelastic METAL alloys (e.g., nitinol), superelastoplastic METALs, such as, for example, GUM METAL ^TM ) Ceramics, and composites thereof, such as calcium phosphate (e.g., skulite ^TM ) Thermoplastic materials such as Polyaryletherketone (PAEK) (including Polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and Polyetherketone (PEK)), carbon-PEEK composites, PEEK-BaSO4 polymeric rubber, polyethylene terephthalate (PET), textiles, silicones, polyurethanes, silicone-polyurethane copolymers, polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers (including polyphenylene, polyamides, polyimides, polyetherimides, polyethylene, epoxy resins), bone materials (including autograft, allograft, xenograft or transgenic cortical and/or pithelial bone) and tissue growth or differentiation factors, partially resorbable materials (such as, for example, a composite of a metal and a calcium-based ceramic, a composite of PEEK and a resorbable polymer), fully resorbable materials (such as, for example, a calcium-based ceramic, such as phosphoric acid, phosphate)Calcium, tricalcium phosphate (TCP), hydroxyapatite (HA) -TCP, calcium sulfate), or other resorbable polymers such as polyketone (polyaetide), polyglycolide, polytyrosine carbonate, polycaprolactone (polycaprolactone), polylactic acid, or polylactide (polylactic), and combinations thereof.

In various embodiments, the component may be coated with, for example, ceramic, titanium, and/or other biocompatible materials to provide (a) macro-scale, (b) micro-scale, and/or (c) nano-scale surface textures. Similarly, the component may undergo a subtractive manufacturing process to provide a surface texture configured to promote bone integration and cell adhesion, as well as osteoblast maturation. Example surface texturing of additive and subtractive manufacturing processes may include (a) macro-scale structural features having a maximum peak-to-valley height of about 40 microns to about 500 microns, (b) micro-scale structural features having a maximum peak-to-valley height of about 2 microns to about 40 microns, and/or (c) nano-scale structural features having a maximum peak-to-valley height of about 0.05 microns to about 5 microns. In various embodiments, for example, the three types of structural features may overlap each other. In addition, such surface textures may be applied to any surface, for example, both the exterior exposed surface of the component and the interior non-exposed surface of the component. Further discussion of relevant surface textures and coatings is described in U.S. patent No. 11,096,796, entitled interbody spinal implant (Interbody spinal implant having a roughened surface topography on one or more internal surfaces) with rough surface topography on one or more interior surfaces, filed on, for example, 3, 4, the entire disclosure of which is incorporated herein by reference in its entirety. Thus, it should be appreciated that any of the coating and texturing processes described in U.S. patent No. 11,096,796 may be applied to any of the components of the various embodiments disclosed herein, e.g., the exposed and interior surfaces of the end plates. Another example technique for manufacturing orthopedic implants having surfaces with osteoinductive roughness features including micro-and nano-scale structures is disclosed in U.S. patent No. 10,821,000, which is incorporated herein by reference in its entirety. In addition, examples of commercially available products may be those made by Adaptix sold by Mei Dun force Spine (Medtronic Spine) ^TM An interbody system comprising a system consisting of a titanium nanoLOCK ^TM And (5) manufacturing the titanium cage.

Referring generally to fig. 1-5, various views of an expandable implant 100 in a collapsed position are illustrated. Fig. 1-2 are various perspective views of an expandable implant 100. Fig. 3 is a top-down view of the expandable implant 100. In an example embodiment, the expandable implant 100 may include a proximal end 100P, a distal end 100D, and first and second lateral sides 100L. In addition, for example, a pair of bone screw holes 11, 21 may be positioned on the proximal end 100P. In various embodiments, the bone screw holes 11, 21 may include corresponding bone screw retaining mechanisms 11a, 21a (which may also be referred to as anti-back out locking mechanisms). In this example embodiment, the bone screw retaining mechanism 11a, 21a includes a flexible tang member having a hook at an end thereof that allows the flexible tang member to allow outward bending away from the corresponding bone screw hole 11, 21 in a lateral direction during initial installation of the bone screw and back inward bending toward the corresponding bone screw hole 11, 21 to prevent backing out of the corresponding bone screw. For example, when bone is installed in the bone screw hole 11, 21, the bone screw retaining mechanism 11a, 21a may flex outwardly as the underside of the head portion contacts the inclined surface 11c (see fig. 19).

In various embodiments and as shown in fig. 1-2, the mounting tangs 19, 29 may extend, for example, in a proximal direction (which may also be referred to as a forward direction, depending on the surgical technique and orientation). In various embodiments, the implant 100 may be referred to as an externally driven expandable implant because the end user or surgeon may use surgical tools to open and close the implant 100, e.g., to expand the implant 100. For example, the external tool may adjust the lordotic angle of the implant 100, as will be explained in detail with respect to fig. 20-25. Once the implant 100 is expanded to the proper anterior angulation (also referred to as the tilt angle), the end user may fix the relative angle of the superior endplate 10 with respect to the inferior endplate 20 by, for example, tightening the locking screw 50. In some embodiments, the upper endplate 10 may be referred to as a "rostral" endplate, while the lower endplate 20 may be referred to as a "caudal" endplate.

The locking screw 50 may also be used in other embodiments, such as fixation of a posterior rod, fixation of pedicle screws, and other fixation screw configurations. Additionally, in some embodiments, the locking screw 50 may be referred to as a "break screw".

At least one advantage of relying on an external tool to adjust the angle of the lordosis of the implant 100 may be that the internal components of the implant 100 are reduced relative to other forms of implants that rely on, for example, various movement mechanisms and/or expansion mechanisms. Thus, in various embodiments, implant 100 may have a relatively large void space within its interior that may facilitate the fusion process during the ACDF procedure. For example, implant 100 may have a relatively large interior volume 101 that is open through superior endplate 10 and inferior endplate 20, which may be filled with, for example, bone graft material.

As shown in fig. 3, implant 100 may extend from proximal end 100P (according to the surgical technique and final orientation, which may also be referred to as the anterior end) to distal end 100D (according to the surgical technique and final orientation, which may be referred to as the posterior end) in a proximal-to-distal direction (according to the surgical technique and final orientation, which may also be referred to as the longitudinal direction and/or front-to-back direction), for example, through an axis P-D passing through the center of implant 100. For example, the implant 100 may extend in a width direction (also referred to as a lateral direction) from a first lateral side 100L to a second lateral side 100L by an axis W-W passing through the center of the implant 100 and the center of the locking screw 50. The axis P-D may be perpendicular and/or substantially perpendicular to the axis W-W. For example, the proximal-to-distal direction may be perpendicular to the width direction. Additionally, the width of the implant may taper from the widest proximal end 100P to the narrowest distal end 100D. In various embodiments, implant 100 may extend in a height direction from superior endplate 10 to inferior endplate 20 (which may also be referred to as a cephalad-caudal and/or vertical direction depending on the surgical technique and final orientation).

Fig. 4 is a side view of the expandable implant 100. In the example illustration, the upper end plate 10 is shown connected to the lower end plate 20 such that the upper end plate is pivotable about a hinge member 40. In an example embodiment, the hinge member 40 includes an arcuate track portion of the lower end plate 20 that extends, for example, in the width direction. In other embodiments, the hinge member 40 may be inverted relative to the upper and lower end plates as compared to that shown in fig. 4. In an example embodiment, the hinge members 40 may nest within corresponding arcuate cavities of the upper end plate 10 such that the upper end plate 10 may expand and/or otherwise rotate about the hinge members 40. Additionally, in various embodiments, the upper endplate 10 and/or the lower endplate 20 may include various engagement elements 14 for engagement with adjacent bony structures, such as toward the vertebrae. In an example embodiment, the engagement element includes a series of alternating tracks extending in the width direction and valleys therebetween. In some embodiments, the valleys may be inclined at about 20-40 degrees, and in at least one embodiment, the valleys may be at an angle of about 30 degrees relative to the corresponding track (see fig. 42A and 42B). At least one advantage of such an orientation may be that the expulsion of the implant 100 in both the lateral direction and the proximal-to-distal direction has relatively greater resistance and/or inhibition. However, claws, hooks, dimples, tips, etc. are also considered example engagement elements 14. In some embodiments, an acid etching process may be utilized to form a roughened or textured surface to facilitate fixation of the implant between bony portions and/or to inhibit expulsion of the implant 100.

Fig. 5 is a rear perspective view of the expandable implant 100. In the example illustration, distal end 100D is shown narrower than proximal end 100P. Fig. 6 is a perspective view of the interior of the upper end plate 10. In the example illustration, the distal end of the upper end plate 10 is shown to include an arcuate channel 12 within which a hinge member 40 may be disposed. For example, the proximal end of the upper endplate 10 may include bone screw hole cuts 21b to allow insertion of corresponding relief areas of bone screws through the bone screw holes 21 of the lower endplate 20. For example, the upper endplate 10 may also include a core 15 including a bore 15a extending from its proximal surface 15p to its distal surface 15 d. In various embodiments, the holes 15a may be referred to as "slots" or "screw slots". In some embodiments, the core 15 may be referred to as a support frame and is generally rectangular in shape. In various embodiments, distal surface 15D may be curved and generally faces distal end 100D of implant 100. Fig. 7 is a perspective view of the interior of the lower endplate 20. In the example illustration, the distal end of the lower endplate 20 is shown to include a hinge member 40 in the form of an arcuate track that may be disposed, for example, within the arcuate channel 12 of the upper endplate 10. For example, the proximal end of the lower endplate 20 may include bone screw hole cuts 11b to allow insertion of corresponding relief areas of bone screws through the bone screw holes 11 of the upper endplate 10. For example, the lower endplate 20 may also include a core 25 including a threaded bore 25a extending from its proximal surface 25p to its distal surface 25 d. In some embodiments, the core 25 may be referred to as a support frame and is generally rectangular in shape. In various embodiments, the upper end plate 10 and the lower end plate 20 may each be formed from a single, unitary piece.

Fig. 8 is a perspective exploded view of the expandable implant 100, while fig. 9 is an exploded partial view from a side view of the expandable implant. In the illustrated embodiment, a locking screw 50 is illustrated. For example, the locking screw 50 may include an external thread pattern 51 on an outer circumferential surface thereof. For example, the external thread pattern 51 of the locking screw 50 may have a size and shape generally corresponding to the threaded hole 25a of the core 25 of the lower end plate 20. In various embodiments, the engagement surface 54 may be disposed adjacent to and proximal to the external thread pattern 51. In the illustrated embodiment, the engagement surface 54 is shaped like a washer and is directly connected to the locking screw 50. However, in other embodiments, for example, the engagement surface 54 may be a washer or a separate element. In some embodiments, the engagement surface 54 may be conical and/or spherical. The engagement surface 54 may include a relatively planar and/or flat distal surface and/or proximal surface (anterior/ventral surface). In various embodiments, the proximal end of the set screw 50 may include a bore having an internal threaded surface 52. For example, the cylindrical proximal end may include a bore having a thread pattern disposed on an inner circumferential surface of the cylindrical proximal end. In an example embodiment, the first drive feature 53a and the second drive feature 53b may be disposed adjacent to the set screw 50 and distally relative to the proximal-most end of the set screw. In addition, the first and second drive features 53a, 53b may be disposed proximally relative to the engagement surface 54. In the exemplary embodiment, the drive features 53a, 53b take the shape of a six-leaf, but various other shapes are also contemplated, such as hexagonal, polygonal, quincuncial, and the like. In some embodiments, a surgical driving tool having a corresponding socket may be coupled to the driving features 53a, 53b to cause rotation of the locking screw 50. Similarly, in some alternative embodiments, a driving tool having a protruding threaded member with a thread pattern having a size and shape corresponding to the internal thread surface 52 may also cause rotation of the set screw 50.

As best seen in fig. 9, for example, the set screw 50 may also include a break position 55. In an example embodiment, the break-off position 55 is disposed directly between the drive features 53a, 53b and is designed to shear when sufficient rotational force (torque) is applied to the proximal end of the set screw 50 when the distal end of the set screw 50 is stationary, e.g., the drive feature 53a and the cylindrical end with the internal threaded surface 52 may break when the set screw 50 is secured in the locked position and continuous rotational force (torque) is applied to the proximal end of the set screw 50. In various embodiments, the internal threaded surface 52 may also be used to ensure removal of the break away portion from the patient and to keep the break away portion connected to the surgical/break away tool. As also best seen in fig. 9, the lower end plate 20 may include a first relief 40a and a second relief 40b on opposite sides of the hinge member 40. For example, the first embossment 40a may have a size and shape corresponding to the size and shape of the first portion 12a of the upper end plate 10, and the second embossment 40b may have a size and shape corresponding to the size and shape of the second portion 12b of the upper end plate 10. In various embodiments, the portions 12a, 12b may include, for example, hooks, protrusions, and/or projections. In an example embodiment, the portions 12a, 12b may be disposed on opposite sides of the channel 12 and the cup-shaped hinge member 40 such that the upper and lower end plates 10, 20 may rotate relative to one another without decoupling.

Fig. 10 is a perspective cross-sectional view of the expandable implant 100, while fig. 11 is a cross-sectional view of the expandable implant. In an example embodiment, the upper and lower end plates 10, 20 are coupled together by a hinge member 40, and the core 25 may be located behind the core 15, e.g., the core 25 may be located distally relative to the core 15. In addition, the external side thread pattern 51 of the locking screw 50 may be engaged with the threaded hole 25a of the core 25 and extend through the hole 15a of the core 15. In this way, the distal surface 15d of the core 15 may engage the proximal surface 25p of the core 25 when the locking screw 50 is rotated. For example, by tightening the locking screw 50, the engagement surface 54 of the locking screw 50 pushes against the proximal surface 15p of the core 15, thereby frictionally engaging the upper and lower end plates 10, 20.

Fig. 12 is a side view of the superior endplate 10 for use with at least some embodiments of the expandable implant 100. In an example embodiment, the upper end plate 10 may include an arcuate channel 12 within which the hinge member 40 may be disposed. In various embodiments, arcuate channel 12 may be centered at P ₁ At a first circle and/or center point at P ₁ A segment of a circle at it. Center point P ₁ An axis of rotation may be defined and the upper end plate 10 may rotate and/or pivot relative to the lower end plate 20. For example, the upper end plate 10 may be hingedly coupled to the hinge member 40 as described above, and may be centered about a center point P ₁ The defined rotation axis rotates. Additionally, in various embodiments, the distal surface 15d of the core 15 may be at P from the center point ₁ At and with radius R ₁ A curved surface defined (partially or wholly) by a second circle of (a) a pair of (c) curved surfaces. The proximal surface 15p of the core 15 may also be formed of a material having a radius R ₂ And a center point P ₂ A curved surface defined (in part or in whole) by a segment of a circle. In an example embodiment, P ₂ At point P ₁ Distance D above ₁ At and radius R ₂ Greater than radius R ₁ . In addition, the proximal surface 15p of the core 15 is offset from the nearest side of the upper endplate 10 by a distance D ₂ . In an example embodiment, the center point P ₂ Located at the center point P ₁ However, in other embodiments, the center point P ₂ May deviate by a greater amount or even a lesser amount than illustrated. In some examples, P ₂ May not be at P ₁ Is aligned vertically above. In various embodiments, R ₁ May be about 7mm to 9mm +/-about 1mm, and R ₂ May be about 8mm to 10mm+/-about 1mm, these numbers may be modified in some embodiments to have a larger or smaller footprint. In various embodiments, D ₁ About 0.25mm to about 1.0mm, and D ₂ About 0.25mm to 1.25mm. In at least one embodiment, D ₁ About 0.75mm, and D ₂ About 0.8mm, and R ₂ About 9.2mm.

The above explained offset center point P ₁ And P ₂ R is as follows ₁ And R is ₂ The geometric relationship between them may have several advantages in terms of operability and functionality. At least one advantage is that the superior endplate 10 may have a natural tendency to exert a force against the engagement surface 54 of the locking screw 50 such that the locking screw 50 may function like a wedge preventing the implant 100 from collapsing completely. Another advantage is that a biasing force may be applied that naturally urges the superior and inferior endplates 10, 20 to an expanded position, which helps expand the implant 100 when, for example, between the superior and inferior vertebrae. Still for example, an end user, such as a surgeon, may expand the implant 100, and the offset arrangement explained above may help maintain the function of the implant 100 to be lordotic at a selected angle.

Fig. 13A is a perspective view of a first expandable implant, fig. 13B is a perspective view of a second expandable implant, fig. 14A is a perspective view of a third expandable implant, fig. 14B is a perspective view of a fourth expandable implant, and fig. 15 is a perspective view of a fifth expandable implant. In a series of illustrations, it is shown that various embodiments in accordance with the principles of the present disclosure may have different dimensions depending on the particular location in the human body and the particular anatomy of the particular patient. For example, fig. 13A illustrates a first height H between the upper and lower end plates 10, 20 ₁ Or thickness of the first expandable implant 100, fig. 13B illustrates a first expandable implant having a second height H ₂ Or thickness of the second expandable implant 100, fig. 14A illustrates a third height H ₃ Or thickness of the third expandable implant 100, fig. 14B illustrates a third expandable implant having a fourth height H ₄ Or thickness of the fourth expandable implant 100, fig. 15 illustrates a fifth height H ₅ Or fifth expandable implant 100 of thickness. At least one ofIn some embodiments, for example, H ₁ Can be about 5mm, H ₂ May be about 6mm, H ₃ May be about 7mm, H ₄ Can be about 8mm, H ₅ May be about 9mm. In various embodiments, the tilt angle between the upper end plate 10 and the lower end plate 20 may be about 4 degrees to about 15 degrees in the expanded configuration (e.g., angled and/or inclined configuration).

Fig. 16 is a side view of the expandable implant 100 in an expanded configuration. For example, in comparison to the closed configuration, in the expanded position, the distance D between the upper endplate 10 and the lower endplate 20 at the proximal end 100P ₃ May be relatively large. In addition, the tilt angle α of the expanded position may be relatively large, for example, as compared to the closed configuration. In this embodiment, implant 100 may have a height H corresponding to FIG. 13A ₁ And is about 5mm in the closed configuration. In the expanded configuration illustrated in FIG. 16, D ₃ May be about 8mm to 9mm, and α may be about 10 degrees to about 20 degrees. In at least one embodiment, for example, D ₃ May be 8mm in the fully expanded position and alpha may be about 15 degrees.

Fig. 17 is a side view of the expandable implant 100 showing the bone screw trajectory 99. For example, in the exemplary embodiment, the central bone screw trajectory 99 of the bone screw 97 is shown at an angle β relative to a plane 98 that passes through the center of the implant from a first lateral side to a second lateral side. In addition, the bone screw trajectory 99 may vary, for example, +/- γ degrees. In various embodiments, B may be about 30 degrees to about 50 degrees, and γ may be about 2 degrees to about 10 degrees. In an example embodiment, β may be about 40 degrees and γ may be about 5 degrees.

Fig. 18 shows a region a ₁ Is shown in front view and fig. 19 is an enlarged area a of fig. 18 ₁ Front view of (c). In the illustrated embodiment, the bone screw 97 is in a position extending through the bone screw hole 11 where the bone screw cannot be withdrawn due to the bone screw retaining mechanism 11 a. The bone screw retaining mechanism 11a includes an inclined surface 11c such that when the bone screw 97 is installed, the underside of the head portion of the bone screw 97 directly contacts the inclined surface 11c, thereby pushing the bone screw retaining mechanism 11a laterally outward away from the bone screw hole 11, for example. Thereafter, when you are When the bone screw 97 is installed and the head portion of the bone screw 97 is located below the inclined surface 11c, the bone screw retaining mechanism may be bent back toward the bone screw hole 11 so that the bone screw retaining mechanism will prevent the bone screw 97 from backing out, e.g., the blocking surface of the bone screw retaining mechanism 11a may contact the upper surface of the head portion of the bone screw 97. In an example embodiment, the bone screw retaining mechanism 11a includes a flexible arm (or spring tab) having an inclined surface 11c (or ramp) disposed on a side end of the implant 100 adjacent the bone screw hole 11.

Referring generally to fig. 20-24, an insert 200 for use with the disclosed expandable implant 100 is illustrated. For example, the insert 200 may extend in a longitudinal direction from the proximal end 200p to the distal end 200d. The insert 200 may include a pair of handles 230, a handle lock 202, and a mounting arm 210 for securely coupling to, for example, the mounting tangs 19, 29 of the implant 100. The insert 200 may also include a tightening knob 211 that is connected to a drive shaft 220 having a drive end 221. The drive end 221 may have a size and shape that generally corresponds to the size and shape of the various drive features (e.g., the internal threaded surface 52, the first drive feature 53a, and/or the second drive feature 53 b) of the locking screw 50. In the example embodiment shown in fig. 24, the drive end 221 includes an end portion having an external threaded surface that is sized and shaped to correspond to the internal threaded surface 52 of the locking screw 50. In various embodiments, tightening knob 211 may rotate drive shaft 220 and drive end 221 to engage drive end 221 with locking screw 50 and pull implant 100 toward insert tool 200 such that mounting tangs 19, 29 are securely nested within corresponding channels of mounting arm 210. In addition, the end user may rotate the insert 200, for example, to transmit rotational force to the locking screw 50 through the drive end 221 via the first drive feature 53a and/or the second drive feature 53 b.

As best seen in fig. 23A and 23B, the insert 200 may include a pair of handles 230, a fixed arm 252, a primary pivot arm 250, and a secondary pivot arm 251. For example, to expand the implant 100, the end user may toggle the handle lock 202 to the unlocked position and push down on the thumb notch 231 of the handle 230, which is connected to the primary pivot arm 250 and the secondary pivot arm 251. In so doing, for example, the primary pivot arm 250 may pivot relative to the intermediate pivot point 240 and the secondary pivot arm 251 may pivot relative to the distal pivot point 245. For example, the path of travel of the secondary pivot arm 251 can be raised on the corresponding mounting tang 19 or 29 and cause the upper and lower end plates 10, 20 to be proximally separated from one another. In doing so, the end user may lordotate implant 100 at a desired angle. For example, as best seen in fig. 24, the secondary pivot arm 251 has been raised over the mounting tang 19, which nests in a corresponding channel of the mounting arm 210.

Once the implant 100 is advanced to the desired configuration, the end user may rotate the drive shaft 220 and drive end 221 to tighten the locking screw 50 as previously described. After the locking screw 50 is relatively tightened, the end user may continue to apply rotational force to the locking screw 50 until the proximal portion including the cylindrical portion having the internal threaded surface 52 and the first drive feature 53a are broken at the broken position 55. For example, once the locking screw 50 is tightened to the design torque, the locking screw 50 may shear as previously described. At least one advantage of using locking screw 50 is that the locking screw may prevent over tightening that may cause deformation of implant 100. As shown in fig. 25, implant 100 has been expanded to a desired position and/or lordotic angle. In addition, the locking screw 50 has locked the relative position of the upper end plate 10 with respect to the lower end plate 20, and the proximal portion of the locking screw 50 has been broken as described above.

Fig. 26 and 27 are various views of a surgical instrument 300 for use with the disclosed expandable implant 100. In some embodiments, the surgical instrument 300 may be referred to as a break instrument and may be used to break the mounting tangs 19, 29 of the implant 100. In an example embodiment, the surgical instrument 300 includes a first instrument 310 and a second instrument 320. The first instrument 310 may extend in a longitudinal direction from the handle 312 to the gripping end 311. Similarly, the second instrument 320 may extend in a longitudinal direction from the handle 322 to the grasping end 321. The gripping ends 311, 321 may include channels having a size and shape that generally corresponds to the mounting tangs 19, 29. For example, as best seen in fig. 27, the mounting tangs 19, 29 may be inserted into corresponding channels of the gripping ends 311, 321. After the mounting tangs 19, 29 are nested within the gripping ends 311, 321, the end user may push laterally outward and/or inward against the handles 312, 322 to disengage the corresponding mounting tangs 19, 29. For example, as shown in fig. 28, the expandable implant 100 is in an expanded and forwardly projecting configuration, and the proximal portion of the locking screw 50 and tangs 19, 29 have been disconnected.

Fig. 29 is a reference diagram showing a human spinal column in which various disclosed implant embodiments may be installed. Fig. 30 is a reference view of various planes and reference directions in which the various implant embodiments disclosed may be referenced to the patient 1 moving or acting.

Referring generally to fig. 31-37, a second implant 400 embodiment is disclosed. Implant 400 may include the same, similar, and/or substantially the same components and functions as described above with respect to implant 100. Therefore, duplicate descriptions will be omitted. It should be understood that the various components and functions of implant 100 may be readily combined with implant 400 and vice versa, unless the context clearly indicates otherwise.

Fig. 31 is a perspective view of a second implant 400 embodiment. In this embodiment, the implant 400 extends between the proximal end 400P and the distal end 400D in a proximal-to-distal direction and between the first side end 400L and the second side end 400L in a width direction. In addition, implant 400 includes an upper endplate 410 and a lower endplate 420 that have features and functions substantially similar to those described above with respect to upper endplate 10 and lower endplate 20 of implant 100. However, in this embodiment, the upper end plate 410 may include a first grip tab 419 extending in a proximal direction from the proximal end 400P of the upper end plate 410. Similarly, the lower endplate 420 may include a second grip tab 429 extending in a proximal direction from the proximal end 400P of the lower endplate 420. In this embodiment, the size and shape of first gripping tab 419 is substantially the same as the size and shape of second gripping tab 429. However, in other embodiments, first gripping tab 419 and second gripping tab 429 may have different sizes and shapes, for example, to bias the implant toward a surgical instrument and/or insertion orientation. In this embodiment and in the closed position, each gripping tab 419, 429 is disposed at approximately the same distance from the rotational axis of the break-away set screw 450. In this embodiment, for example, the gripping protrusions 419, 429 can replace the need for the tangs 19, 29 of the implant 100. However, the concepts of utilizing the break-away tangs 19, 29 and grip tabs 419, 429 are not necessarily mutually exclusive and the properties of one may be combined and/or modified according to the other.

In various embodiments, the gripping protrusions 419, 429 may include various types of contours to facilitate gripping of the gripping protrusions 419, 429 with a corresponding insert, such as a surface indentation, surface protrusion, channel, or the like. In an example embodiment, the gripping tab 419 includes an upper gripping surface 419A that includes, for example, a recessed portion at its proximal most end and a raised chamfer portion. In addition, the gripping tab 419 includes a lower gripping surface 419B that includes, for example, a recessed portion at its proximal-most end and a raised chamfer portion. Likewise, the clamping projection 429 includes an upper clamping surface 429A that includes a recessed portion, e.g., at its proximal most end, and a raised chamfer portion. In addition, the clamping projection 429 includes a lower clamping surface 429B that includes a recessed portion, for example, at its proximal-most end and a raised chamfer portion. In this manner, the gripping protrusions 419 and 429 are shaped like dovetails, and the corresponding insert tool may include correspondingly shaped dovetailed grooves that may grasp and/or slide over the gripping protrusions 419 and 429 (not illustrated).

Referring generally to fig. 32, 33 and 34, various exploded partial views of implant 400 are illustrated. Fig. 32 is a first perspective exploded partial view of implant 400, fig. 33 is a second perspective exploded partial view of implant 400, and fig. 34 is a side exploded partial view of implant 400. In an example embodiment, the superior end plate 410 and the inferior end plate 420 of the implant 400 may be hingedly coupled together by a hinge member 440 and an arcuate channel 412, for example, having similar properties as described above with respect to the hinge member 40 and the channel 12 of the implant 100. In addition, the upper endplate 410 may also include a core 415 having a bore 415A, and the lower endplate 420 may include a core 425 having a threaded bore 425A, for example, having similar properties to the core 15 and core 25, as described above with respect to the implant 100. In an example embodiment, implant 400 utilizes break-out screws 450 for locking the position of superior endplate 410 and inferior endplate 420. For example, the break screw 450 may include an external thread pattern 451 on an outer circumferential surface thereof. For example, the external thread pattern 451 of the break screw 450 may have a size and shape that generally corresponds to the threaded hole 425a of the core 425 of the lower end plate 420. In various embodiments, the engagement surface 454 may be disposed adjacent to and proximal to the external thread pattern 451. In an example embodiment, the engagement surface 454 is shaped like a washer and is directly connected to the break screw 450. However, in other embodiments, for example, the engagement surface 454 may be a washer or a separate element. In some embodiments, the engagement surface 454 may be conical. In example embodiments, the engagement surface 454 may include a relatively planar and/or flat distal surface and/or a proximal surface.

In various embodiments, the proximal end of the break screw 450 can include a first flexible tang 452A and a second flexible tang 452B defining a discontinuous cylindrical bore 452 therebetween. Additionally, the first flexible tang 452A and the second flexible tang 452B may each include a protrusion at their proximal ends that is shaped like a segment of an annular ring. In an example embodiment, the first flexible tang 452A can flex inwardly under load toward the second flexible tang due to the gap between the first flexible tang 452B and vice versa. At least one advantage of this configuration is that it can help secure the break screw 450 to a corresponding driving tool (not illustrated) and help retain the break portion. For example, the driving tool may include a driving end having a concave cavity with a size and shape corresponding to the driving features 453A, 453B. In various embodiments, for example, the cavity can include a pair of notches that correspond in size and shape to the protrusions of the flexible tangs 452A and 452B. In use, an end user can align the flexible tangs 452A, 452B with the cavity, pushing down against the flexible tangs 452A, 452B, which can cause the flexible tangs to flex inwardly toward one another such that the flexible tangs can slide within the cavity until the lobes of the flexible tangs 45A and 452B are located within the corresponding recesses of the driving tool. Thereafter, the end user may continue to rotate and/or tighten the break screw 450. In this way, after the proximal portion of the break screw 450 breaks, the proximal portion can remain retained by the insert as the flexible tangs 452A and 452B are positioned within the corresponding recesses.

In some embodiments, the aperture 452 may be understood as a cylindrical protrusion extending in the proximal direction, and the cylindrical protrusion has a first slit and a second slit extending along its length such that the cylindrical protrusion is compressible. In an example embodiment, the first and second drive features 453A, 453B may be disposed near the break screw 450 and distally with respect to a proximal-most end of the break screw. Additionally, the first and second drive features 453A, 453B may be disposed proximally relative to the engagement surface 454. In various embodiments, the off position may be located between and/or near the drive features 453A, 453B, as will be explained in further detail below. In the example embodiment, the drive features 453A, 453B take the shape of a six-leaf, but various other shapes are also contemplated, such as hexagonal, polygonal, quincuncial, and the like. In some embodiments, a surgical drive tool having a corresponding socket may be coupled to drive features 453A and/or 453B to cause rotation of break screw 450. Similar to that described above with respect to locking screw 50, once the break-away screw 450 is sufficiently tightened, the proximal portion may break and/or shear while the distal portion may remain coupled to the implant 400, thereby locking the relative orientations of the superior and inferior endplates 410, 420 in place.

As best seen in fig. 35-37, the break screw 450 may extend in a longitudinal direction along a longitudinal axis L-a coaxially aligned with the break screw 450. Fig. 35 is a first side view of the break screw 450, wherein the upper surface 452A and the lower surface 452B of the discontinuous hole 452 are visible. Fig. 36 is a second side view of the break screw 450 rotated approximately 90 degrees relative to fig. 35, wherein only the upper surface 452A is visible. Referring to fig. 37, in various embodiments, the break-off location 455 may include a recessed break surface F-S that is inset relative to the leading edge (nearest side edge) of the drive feature 453A. At least one advantage of the concave fracture surface may be to prevent and/or inhibit fragile tissue from contacting the relatively sharp end of the fracture surface. In the example illustration, the relative position of the concave fracture surface is indicated by the dashed line F-S. In an example embodiment, the break position 455 may be considered, for example, as the boundary between the proximal portion 450A and the distal portion 450B of the break screw 450. In this embodiment, the boundary between drive features 453A and 453B includes a necked portion 458 extending from the distal end of drive feature 453A to an inset portion of drive feature 453B that is inset relative to the outermost and/or most proximal surface of drive feature 453B to define a portion of break-away set screw 450 having a minimum cross-sectional diameter. Thus, when the break screw 450 is sufficiently tightened within the threaded bore 425A of the core 425 such that the break position 455 experiences sufficient torque, the proximal portion 450A may be broken from the distal portion 450B. For example, when sufficient rotational force is applied to the proximal end of the break screw 450 when the distal end of the break screw 450 is stationary, i.e., when the break screw 450 is secured in a locked position and a continuous rotational force (torque) is applied to the proximal end of the break screw 450, the drive feature 453A and the cylindrical end with the discontinuous bore 452 may break. For further explanation of similar conditions for implant 100, see fig. 10 and 11 and their corresponding discussion.

Referring to fig. 38-42, an exemplary swaging process is performed on the distal-most end of the break screw 450. Fig. 38 is a perspective view of a swage mount 500, and fig. 39 is a cross-sectional view of the swage spindle and distal end 450D of a break screw 450 prior to the start of the swaging process. Fig. 40 is a cross-sectional view showing the result of the swaging process, and fig. 41 is an enlarged view of a region S-W of fig. 40. In an example embodiment, swage fixture 500 includes a swage head (swage ram) 501 and a swage mandrel 503 supported by the base of the apparatus. For example, swage spindle 503 may include a boss corresponding to and slightly larger than distal-most recess 498 (swage hole) of break screw 450. As seen in region S-W of FIG. 40, as swage mandrel 503 advances into distal-most recess 498 (swage hole), a flattened portion 499 (swage portion) is formed at the distal-most end of break screw 450. An example advantage of a swaged end may be that the swaged end helps to hold the break-away screw 450 such that the break-away screw serves as a stop structure to prevent the break-away screw 450 from backing out of the implant 100.

It should be appreciated that while the break-off screw 450 is illustrated with the implant 400 and in the case of an intervertebral implant, the concepts of the break-off screw 450 may be applied to other embodiments for alternative purposes, such as for inserting a funnel in a pedicle screw to tighten a rod. It should be understood that the various aspects disclosed herein may be combined in different combinations than specifically presented in the specification and drawings. For example, features, functions, and components from one embodiment may be combined with another embodiment and vice versa, unless the context clearly indicates otherwise. Similarly, features, functions, and components may be omitted unless the context clearly indicates otherwise. It should also be appreciated that, depending on the example, certain acts or events of any of the processes or methods described herein can be performed in a different order, may be added, combined, or omitted entirely (e.g., not all of the described acts or events may be required to perform the techniques).

Referring generally to fig. 42-51, a third implant 400Z and surgical tool 600 for use with various implants are disclosed. Fig. 42A-42B illustrate a third embodiment of an implant 400Z. Implant 400Z may have the same, similar, and/or substantially the same components and functions as described above with respect to implant 400. Therefore, duplicate descriptions will be omitted. The difference may be that the break screw 450 does not include a discontinuous cylindrical bore 452 (see fig. 34) having tangs 452A, 452B, for example. Rather, the break screw 450 may include an uninterrupted continuous cylindrical bore 452Z within the scope of inclusion. In some embodiments, a similar screw may be used that is not a break screw, but may be referred to as a locking screw. In addition, for example, in this embodiment, the implant 400Z may include a first grip recess 419Z and a second grip recess 429Z (see fig. 42A) instead of the grip tabs 419, 429 (as shown in fig. 33). For example, in various embodiments, the first clamping recess 419Z may be formed as part of the upper end plate 410 and the second clamping recess 429Z may be formed as part of the lower end plate 420.

In various embodiments, the grip notches 419Z, 429Z may include various types of contours to facilitate coupling with a corresponding surgical tool 600. In this embodiment, the gripping notches 419Z, 429Z each comprise a channel-shaped notch extending in a proximal-to-distal direction, the channel-shaped notch having an upper curved surface 419S, 429S and a lower curved surface 419I, 429I. In addition, the clamping notches 419Z, 429Z each have an open channel portion 419X, 429X adjacent to the break screw 450 to the extent that a break screw is included. As will be explained in further detail below, for example, the corresponding clamping protrusions of the surgical tool 600 may have substantially similar dimensions and shapes as the clamping recesses 419Z, 429Z.

Fig. 43A to 43B illustrate an embodiment similar to fig. 42A to 42B. As shown, implant 400Z includes angled engagement features 14. In the example embodiment, the engagement features 14 extend diagonally across the exposed uppermost surface of the upper end plate 410 and the exposed lowermost surface of the lower end plate 420. The engagement features 14 comprise sequentially spaced flat top rails with rounded bottom valleys 14V therebetween. As best seen in the top-down view of fig. 43B, the engagement features 14 of the upper end plate 410 are oriented at an angle B relative to the proximal face 410F of the upper end plate 410. Similarly, the engagement features 14 of the lower end plate 420 are oriented at an angle β relative to a proximal face 420F (see fig. 43A) of the lower end plate 420. In various embodiments, the angle β may be about 20 degrees to 40 degrees, and in at least one embodiment, the angle β may be at an angle of about 30 degrees. At least one advantage of this orientation may be that the distraction implant 400Z has a relatively greater resistance and/or inhibition relative to embodiments in which the engagement features extend only horizontally across the implant 400Z. In the example embodiment of fig. 43A-43B, by orienting the engagement features 14 diagonally, the implant 400Z may resist expulsion in multiple directions, e.g., forward bending/extension and lateral bending.

Referring generally to fig. 44-48, various views of a surgical tool 600 are disclosed. Fig. 44 illustrates a surgical tool 600 coupled to an implant 400Z. Fig. 44 is a perspective view of a surgical tool 600; FIG. 45 is a first side view of the surgical tool 600; and fig. 46A is a second side view of the surgical tool 600. Fig. 46B is a third side view of the surgical tool 600 in the operative position, and fig. 46C is a perspective view of the surgical tool 600 in the operative position of fig. 46B. Fig. 47A is an exploded partial view of the surgical tool 600 with selected portions removed for ease of understanding, and fig. 47B is an exploded partial view of the surgical tool 600 showing additional details and portions. Fig. 48 illustrates a surgical tool 600 just prior to coupling with implant 400Z. In an example embodiment, the tool 600 may be used for several purposes. For example, the tool 600 may be used to insert the implant 400Z, expand the implant 400Z, and in some embodiments, also rotate the break-off screw 450 to divide it into two portions along the break-off position 455 (see fig. 34).

Referring to the perspective view of fig. 44 and the exploded partial view of fig. 47A and 47B, the tool 600 can include a gripping handle 601 securely coupled to the first body portion 607. The first body portion 607 may rotatably support the inner shaft 606 and the outer shaft 602 therein. The shafts 606, 602 may extend through the bore 607A of the first body portion 607 from proximal to distal in a longitudinal direction. The inner shaft 606 may be fixedly connected to the knob 603 at the proximal end 600P, while the outer shaft 602 may be fixedly connected to the rotating handle 604 at the proximal end 600P. The inner shaft 606 may extend through the outer shaft 602 and include a thread pattern 606T at a distal end thereof for secure connection to corresponding threads 456 of the break screw 450 (see, e.g., fig. 42B). By rotating the knob 603, the inner shaft 606 can be independently rotated relative to the outer shaft 602. In addition, the outer shaft 602 can be independently rotatable relative to the inner shaft 606, for example, by rotating the rotating handle 604. In general, both the inner shaft 606 and the outer shaft 602 will interact and/or couple with the break-out screw 450, as will be explained in further detail below.

Referring to fig. 45 and 46A-46C, the tool 600 may include an actuator 605 in the form of a trigger that is connected to a first body portion 607 at a pin 605C. For example, by pivoting the linkage assembly 608 including the first arm 610 and the second arm 611 relative to the third fixed arm 620, the actuator 605 may be operable to expand the implant 400Z. The second arm 611 may be coupled to the actuator 605 via the pin 605B such that the pin 605B may linearly translate forward and rearward in a proximal-to-distal direction within the slotted bore 605A. Further, the second arm 611 may be coupled to the first arm 610 via a pin 610B such that the second arm 611 may pivot up and down. Additionally, the first arm 610 may be coupled to the third arm 620, and in various embodiments, the third arm 620 may be fixed relative to the first body portion 607. Additionally, the third arm 620 may include a protrusion 620B that may be slidably located within a curved vertical slot (e.g., slot 610A) to guide the movement of the arm 610 as it pivots up and down. As best seen in fig. 46B and 46C, depressing the actuator 605 may pivot the linkage assembly 608 by moving the second arm 611 distally such that the first arm 610 pivots relative to the third arm 620, and the implant 400Z is expandable.

Referring back to fig. 44, the third arm 620 may include a bore extending therethrough in a proximal-to-distal direction for receiving a linearly translatable shaft 621. For example, the shaft 621 may independently move back and forth in the proximal-to-distal direction within the through hole 624 (see fig. 47A and 47B) of the third fixed arm 620. The shaft 621 may include a filling handle at its proximal end, allowing the end user to manipulate the shaft 621 in a back and forth motion (proximal and distal motion in a proximal-to-distal direction). In some embodiments, the end user may rotationally translate the fill handle 622 in a clockwise or counterclockwise motion, for example, to lock the shaft 621 in a relative position. Additionally, in some embodiments, when the shaft 621 is not in the locked position, depressing the actuator 605 will not expand the implant 400Z, for reasons that will be explained in more detail below.

Referring to fig. 48, the first arm 610 may include a gripping protrusion 619 having a size and shape generally corresponding to the size and shape of the gripping recess 419Z. In addition, for example, the first arm 610 may include a counter-torque surface 615 having a size and shape that generally corresponds to the size and shape of the proximal surface of the upper end plate 410. Similarly, the shaft 621 extending through the stationary arm 620 can include a grip tab 629 having a size and shape that generally corresponds to the size and shape of the grip recess 429Z (shown in fig. 42A). In addition, for example, the second arm 620 may include a counter-torque surface 625 having a size and shape that generally corresponds to the size and shape of the proximal surface of the lower endplate 420. In this manner, when shaft 621 is moved distally such that boss 629 is located within recess 429Z and boss 619 is located within recess 419Z (as shown in fig. 42A), the end user may activate actuator 605 to expand implant 400Z while surfaces 615, 625 resist torsional movement of implant 100. 46B and 46C, the end user may depress the actuator 605 by squeezing the trigger, which in turn may cause the linkage assembly 608 to pivot the first arm 610 relative to the fixed arm 620 so that the tool 600 may push the upper end plate 410 and the lower end plate 420 away from each other.

With reference to the cross-sectional views of fig. 49, 50 and 51, additional features and functions of the tool 600 will be explained. In fig. 49 and 50, the threaded end of the inner shaft 606 is shown in threaded engagement with a threaded bore 456 of the break screw 450. In addition, proximal drive feature 453A fits within a corresponding female drive feature 602A (see fig. 48) at the distal-most end of outer shaft 602. As previously described, the inner shaft 606 and the outer shaft 602 can operate independently. In use, an end user may initially position the inner shaft 606 near/within the front of the threaded bore 452 and rotate the inner shaft 606 via the knob 603. As the inner shaft 606 rotates, the implant 400Z is pulled toward the tool 600. Fig. 49-51 illustrate the implant 400 after the inner shaft 606 has been rotated sufficiently such that the implant 400Z abuts the counter torque surfaces 615, 625 and the gripping protrusions 619 can be positioned within corresponding gripping recesses 419Z. Referring to fig. 51, for example, once the implant 400Z is sufficiently pulled toward the tool 600, the end user may actuate the shaft 621 by pushing the filling handle 622 to overcome the biasing force of the spring 623 such that the clamping protrusions 629 may be positioned within corresponding clamping recesses 429Z. In some embodiments, the end user may rotate the filling handle 622, thereby preventing the biasing force of the spring 623 from pushing the shaft 621 away from the implant 400Z. At this point, implant 400Z may be in a position to operably engage tool 600.

For example, once implant 400Z is in an operably engaged position, the end user may insert implant 400Z into the intervertebral space between the superior and inferior vertebrae (cephalad and caudal). After positioning implant 400Z between the superior and inferior vertebrae, the end user may depress actuator 605, thereby pivoting connection assembly 608 and separating superior endplate 410 from inferior endplate 420. Once the end user has expanded the implant 400Z into place, the end user may rotate the turning handle 604, which will rotate the break screw 450 via the first drive feature 453A. The end user may continue to rotate the break-away screw 450 such that it advances into the implant 400Z in a proximal-to-distal direction and locks the implant 400Z in the expanded configuration, similar to that explained above. The end user may continue to rotate the turning handle 604 until the torque applied to the break screw 450 is large enough that the break screw 450 will shear into two portions, similar to that explained above. Notably, the break or shear portion of the break screw 450 can be retained by the tool 600 in view of the threaded coupling of the inner shaft 606 to the threaded bore 452.

Unless specifically defined otherwise herein, all terms are to be given their broadest possible interpretation, including meaning as implied from the specification as well as meaning understood by one of ordinary skill in the art and/or as defined by dictionaries, papers, or the like. It must also be noted that, as used in the specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless otherwise indicated, and the terms "comprises" and/or "comprising" when used in this specification specify the presence of stated features, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.

Referring generally to fig. 52-62, various spinal implants 700 are disclosed. The components of the spinal implant 700 may be made of a bio-accessible material suitable for medical applicationsIs made of materials including metals, synthetic polymers, ceramics, and bone materials and/or composites thereof. For example, the components of the spinal implant 700 may be made of the following materials, either individually or collectively: such as stainless steel alloys, commercially pure titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, superelastic metal alloys (e.g., nitinol), superelastoplastic metals, such as, for example, GUM) Ceramics, and composites thereof, such as calcium phosphate (e.g., skulite ^TM ) Thermoplastic plastics such as Polyaryletherketone (PAEK) (including Polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and Polyetherketone (PEK)), carbon-PEEK composites, PEEK-BaSO4 polymeric rubber, polyethylene terephthalate (PET), textiles, silicones, polyurethanes, silicone-polyurethane copolymers, polymeric rubber, polyolefin rubber, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermoset elastomers, elastomeric composites, rigid polymers (including polyphenylene, polyamides, polyimides, polyetherimides, polyethylene, epoxy resins), bone materials (including autograft, allograft, xenograft or transgenic cortical bone and/or pith bone) and tissue growth or differentiation factors, partially resorbable materials (such as, for example, a composite of metal and calcium-based ceramic, a composite of PEEK and a resorbable polymer), a fully resorbable material such as, for example, calcium-based ceramic, such as calcium phosphate, tricalcium phosphate (TCP), hydroxyapatite (HA) -TCP, calcium sulfate, or other resorbable polymers such as polyketone (polyaetide), polyglycolide, polytyrosine carbonate, polycaprolactone (polycaprolactone), and combinations thereof.

Referring generally to fig. 52-62, various embodiments of an expandable implant 700 are disclosed. Fig. 63-64 are reference diagrams showing the relationship of human spinal column and various medical terms to planes and directions in which various components of implant 700 may function or move.

Fig. 52-53 illustrate an example perspective view of the expandable implant 700 in a partially expanded position, and fig. 54 is a top-down view of the expandable implant 700. As illustrated, the expandable implant 700 may include a proximal end 700p, a distal end 700d, and first and second lateral sides 7001. For example, the proximal end 700p may include a screw guide hole 731 and a pair of clamping notches 719, 729 on opposite sides of the screw guide hole 731. In addition, a pair of bone screw holes 711, 721 may be positioned on the proximal end 700p, for example. In various embodiments and as shown in fig. 52-53, the clamping notches 719, 729 may be formed, for example, as cut-out portions adjacent to the bone screw holes 711, 721. The implant 700 may be referred to as an external expandable implant because an end user, such as a surgeon, may use a surgical tool to open and close the implant 700, e.g., the external tool may adjust the lordotic angle of the implant 700. Once the implant 700 is expanded to the proper anterior angulation (also referred to as tilt angle), the end user may fix the relative angle of the superior endplate 710 with respect to the inferior endplate 720 by, for example, tightening the locking screw 750. At least one advantage of relying on an external tool to adjust the angle of the anterior protrusion of the implant 700 may be that the internal components of the implant 700 are reduced relative to other forms of implants that rely on, for example, various movement mechanisms and/or expansion mechanisms. Thus, in various embodiments, the implant 700 may have a relatively large void space within its interior that may facilitate the fusion process during the ACDF procedure. For example, implant 700 may have a relatively large interior space for filling with bone growth promoting material and/or bone graft.

As shown in fig. 54, for example, the implant 700 may extend from the proximal end 700p to the distal end 700d in a proximal-to-distal direction by an axis A-A passing through the center of the implant 700. For example, the implant 700 may extend in a width direction (also referred to as a lateral direction) from the first lateral side 7001 to the second lateral side 7001 by an axis B-B passing through a center of the implant 700. The axis A-A may be perpendicular and/or substantially perpendicular to the axis B-B. For example, the proximal-to-distal direction may be perpendicular to the width direction.

Fig. 55-56 illustrate exemplary exploded partial views of an expandable implant 700. For example, implant 700 may include an upper endplate 710 and a lower endplate 720 defining a top surface and a bottom surface of implant 700. For example, the upper end plate 710 and the lower end plate 720 may be hingedly coupled to each other via a pin 740. The upper end plate 710 and the lower end plate 720 are adjustable in a vertical direction relative to each other and tiltable relative to each other, i.e. capable of being dispersed and forwardly convex by rotation, e.g. about the pin 740. Additionally, core 730 may be centrally disposed within implant 700, and upper end plate 710 and lower end plate 720 may hingedly couple core 730 via, for example, pins 740. For example, the pin 740 may extend in a lateral direction through the pin receiving holes 712a, 712b of the upper end plate 710, the pin receiving holes 732a, 732b of the core 730, and the pin receiving holes 722a, 722b of the lower end plate 720. In some embodiments, for example, pin 740 may be referred to as a rod or dowel. Additionally, in some embodiments, the upper endplate 710, the lower endplate 720, and the core 730 may be collectively referred to as an inflatable body.

In some embodiments, the pin 740 may be "press fit" (also referred to as an interference fit) "to the core 730 by extending through the pin-receiving holes 732a, 732 b. As used herein, the terms "press fit" and "interference fit" are intended to have their ordinary technical meaning, such as a form of fastening between two mating parts that mate, which form creates a joint that is held together by friction after the parts are pushed together. In some embodiments, for example, the connection of the pin 740 to the core 730 may be a press fit or an interference fit, wherein the components are held tightly together such that the core 730 cannot rotate relative to the pin 740 and/or the pin 740 may be fixed in position relative to the core 730. At least one advantage of utilizing a press fit connection may be that the connection ensures a rigid permanent support of the pin 740 at each tension point defined by the pin receiving holes 732a, 732b without relative movement, thereby reducing wear and/or fatigue while providing a shaft and/or pivot point about which the upper and lower end plates 710, 720 rotate. However, in other embodiments, some rotation may be possible.

In various embodiments, for example, the pin 740 may be "slip fit" to the upper endplate 710 by extending through the pin receiving holes 712a, 712 b. Similarly, in various embodiments, for example, pin 740 may be "slip fit" to lower endplate 720 by extending through pin receiving holes 722a, 722 b. As used herein, the term "slip fit" is intended to have a common technical meaning, for example, a form of fastening between two relatively loose but tightly fitted parts that produces a joint that allows rotation and/or movement.

The proximal end 700p of the upper endplate 710 may include a first bone screw hole 711 extending through the upper surface of the upper endplate 710 for engagement with, for example, the upper vertebra. In an example embodiment, a first bone screw hole 711 extends from the proximal end 700p of the upper endplate 710 through the bone graft hole 701 of the upper endplate 710 (see fig. 54). Additionally, the core 730 may include a first bone screw cutout 735 including an arcuate channel for receiving a bone screw extending through, for example, the first bone screw hole 711.

Similarly, the proximal side 700p of the lower endplate 720 may include a second bone screw hole 721 extending through the lower surface of the lower endplate 720 for engagement with, for example, the lower vertebra. In an example embodiment, a second bone screw hole 721 extends from the proximal end 700p of the lower end plate 720 through the bone graft hole 701 of the lower end plate 720 (see fig. 54). In addition, in various embodiments, for example, each of the upper endplate 710 and the lower endplate 720 may include bone graft holes 701 having substantially the same size and shape. Additionally, the core 730 may include a second bone screw cutout 736 including an arcuate channel for receiving a bone screw extending through, for example, the second bone screw hole 721.

In various embodiments, the core 730 may include screw guide holes 731 (also referred to as locking screw guide holes). For example, screw guide hole 731 can be disposed at a central location of implant 700 at proximal end 700 p. For example, screw guide hole 731 may include a female thread pattern having a size and shape corresponding to the male thread pattern 751 of locking screw 750. Screw guide bore 731 may rotatably support locking screw 750 therein such that rotation of locking screw 750 may result in linear translation of locking screw 750 in a proximal-to-distal direction, e.g., along axis A-A.

In various embodiments, for example, the locking screw 750 may have an outer circumferential surface including a male thread pattern 751 at a distal end thereof. The locking screw 750 may be disposed in the screw guide hole 731 and move back and forth in a proximal/distal direction when the locking screw 750 is rotated. For example, the locking screw 750 may include an inner circumferential surface 752 of any suitable size and shape for engagement with a driver to rotate the locking screw 750. For example, hexagonal, quincuncial, hexagonal, polygonal, etc. In various embodiments, locking screw 750 may include a central bore 753 extending therethrough; however, in some embodiments, the distal end of the locking screw 750 may be closed, and the proximal side of the locking screw 750 may still have a central bore 753 extending partially through the locking screw 750. In at least one embodiment, the distal end of the locking screw 750 is closed and the outer distal surface of the locking screw 750 may have a concave or convex hemispherical and/or cup shape for applying a compressive force at a point. In other embodiments, the distal surface of the locking screw 750 may be substantially flat and/or planar for applying a relatively more distributed compressive force. In an example embodiment, the locking screw 750 may include a head portion 754 including an annular ring that extends laterally beyond a maximum diameter of threads, such as the thread pattern 751. For example, the diameter of the head portion 754 may be greater than the maximum diameter of the thread pattern 751. However, in other embodiments, the diameter of the head portion 754 may be about the same and/or substantially the same as the maximum diameter of the thread pattern 751. In an example embodiment, for example, the locking screw 750 may include a smooth shaft portion 55 disposed centrally between the thread pattern 751 and the head portion 754. This may allow the locking screw 750 to move back and forth a distance within the screw guide hole 731 before the distal surface of the head portion 754 engages the corresponding surfaces of the upper endplate 710 and the lower endplate 720, as will be explained in further detail below.

In various embodiments, locking screw 750 may fix a relative tilt angle (forward protruding angle) between upper end plate 710 and lower end plate 720. For example, locking screw 750 may be rotated to linearly translate and/or move the locking screw from proximal end 700p to distal end 700d, thereby pushing the various contact surfaces of upper endplate 710, core 730, and lower endplate 720 into frictional engagement. Still for example, the locking screw 750 may apply a compressive force, thereby frictionally engaging the upper end plate 710, the core 730, and the lower end plate 720 such that these components lock in relative position with one another, as will be explained in further detail below.

Fig. 57 illustrates a side view of the upper endplate 710. In an example embodiment and as described above, the upper end plate 710 may include a pair of pin receiving holes 712a, 712b. In the side view of fig. 57, only pin receiving aperture 712b is labeled. In various embodiments, for example, the pin-receiving holes 712a, 712b may be coaxially aligned circular holes having the same radius. As illustrated, the pin receiving bore 712b may include a bore having a radius R ₁ And a center point P defining the center of the pin receiving holes 712a, 712b ₁ And/or the rotational axis of rotation about which the upper end plate 710 may rotate and/or pivot. For example, the upper end plate 710 may be hingedly coupled to the pin 740 and may be centered about, for example, the center point P ₁ The defined rotation axis rotates. Additionally, in an example embodiment, the upper end plate 710 may include an engagement surface 716 (see also fig. 61). In various embodiments, the engagement surface 716 may be formed from a material having a radius R ₂ A curved surface defined (in part or in whole) by a segment of a circle. In various embodiments, for example, the center point P of the circle defining the curved engagement surface 716 ₂ Can deviate from the central point P ₁ . In an example embodiment, the center point P ₂ Located at the center point P ₁ Is vertically above the approximate radius R ₁ Is a distance from (a) to (b). However, in other embodiments, the center point P ₂ A greater amount or even a lesser amount of deviation than the examples. In various embodiments, R ₁ May be about 0.5mm to about 1mm, with R ₂ May be about 7mm to about 12mm. In at least one embodiment, R ₁ About 0.75mm and R ₂ About 9.25mm. In various embodiments, lower endplate 720 may also have similar geometric relationships.

Consistent with the disclosure herein, a center point P of deviation ₁ And P ₂ The geometric relationship between them may have several advantages in terms of operability and functionality. At least one advantage is that the upper endplate 710 can have a head on the locking screw 750The natural tendency of the portion 754 to apply a force such that the locking screw 750 may act like a wedge preventing the implant 700 from collapsing completely. For example, in various embodiments, the superior and inferior vertebrae may exert a closing force on the implant 700, and the off-radius arrangement as described above may facilitate the engagement surface 716 to naturally contact the head portion 754 of the locking screw 750. Still for example, an end user, such as a surgeon, may expand the implant 700, and the offset arrangement explained above may help maintain the function of the implant 700 to be lordotic at a selected angle.

Fig. 58 is a side view of implant 700 in a collapsed position. In the illustrated embodiment, the upper endplate 710 is shown to include a plurality of engagement features 15, while the lower endplate 720 is shown to include a plurality of engagement features 25. In example embodiments, the engagement features 715, 725 may include teeth or ridges extending in a lateral direction, for example, across the exposed surface of the implant 700. Fig. 59 is a side view of implant 700 in an expanded position. In the expanded position, upper end plate 710 and lower end plate 720 are shown tilted relative to one another, with core 730 retaining locking screw 750 therein. In the expanded position, the upper endplate 710 may have pivoted upward in a vertical direction about the pin 740, while the lower endplate 720 may have pivoted downward in a vertical direction about the pin 740, such that the implant 700 is forward convex.

Fig. 60 is a rear view of implant 700. In the exemplary embodiment, pin 740 is shown extending through slotted aperture 739 of core 730. In an example embodiment, slot-shaped apertures 739 may extend in a lateral direction on the distal surface of core 730 and include curved ends on opposite lateral sides thereof. In addition, void spaces around pin 740 are shown, which may, for example, aid in bone ingrowth during fusion. Fig. 60 also illustrates that the upper end plate 710 and the lower end plate 720 are pivotally mated together.

Fig. 61 illustrates a front view of implant 700 and a side view of locking screw 750. In the example illustration, a rear side (distal) of head portion 754 is shown as being contactable with screw engagement surface 716 of upper end plate 710 and screw engagement surface 726 of lower end plate 720. The screw engagement surfaces 716, 726 may include curved notches having a profile corresponding to the radius of curvature of the head portion 754. For example, the screw engagement surfaces 716, 726 may be shaped similar to one another and to the locking screw 750 to contact the rear (distal) side of the head portion 754 of the locking screw 750 while also having sufficient lateral clearance for the locking screw 750 to rotate. In an example embodiment, when the locking screw 750 is sufficiently tightened, the rear (distal) side of the head portion 754 may push against the screw engagement surfaces 716, 726, thereby causing various inner surfaces of the upper and lower end plates 710, 720 to frictionally engage and/or bond together, as will be explained below with reference to fig. 62.

Fig. 62 is an exploded partial view of the upper end plate 710, lower end plate 720, and core 730 in rotation to illustrate the various surfaces frictionally engaged and/or bonded together in the locked position. For example, the upper endplate 710 may include a first engagement surface 718 that may engage and/or frictionally engage a corresponding portion of the engagement surface 738 of the core 730. For example, the first bonding surface 718 may extend laterally on an upper inner surface of the upper endplate 710. Similarly, the lower endplate 720 may include a second engagement surface 728 that may engage and/or frictionally engage a corresponding portion of the engagement surface 738 of the core 730. In various embodiments, the bonding surface may be referred to as a high friction surface and/or an engagement surface. In various embodiments, the bonding surface 738 of the core 730 may face in a proximal direction and the bonding surfaces 718 and 728 may face in a distal direction. In at least one embodiment, the bonding surfaces 718, 728, 738 include high friction, roughened, and/or textured surfaces to facilitate seizing. In various embodiments, the bonding surfaces 718, 728, 738 may be surface roughened by a grit blasting process. For example, abrasive blasting processes such as blasting including a surface treatment process for roughening a corresponding treated surface.

Thus, when the locking screw 750 is sufficiently tightened, the head portion 754 may push against the screw engagement surfaces 716, 726 of the upper and lower end plates 710, 720, respectively, pushing the engagement surfaces 718, 728, and 738 into a high friction and direct contact arrangement. In various embodiments, this high friction arrangement is sufficient to withstand the closing compression forces between the upper and lower vertebrae. In addition, locking screw 750 may act as a wedge between curved engagement surfaces 716, 726, further preventing collapse of implant 700. As explained herein, embodiments in accordance with the principles of the present disclosure provide a highly adjustable implant 700 having optimized and/or increased internal void space to facilitate the fusion process. In various exemplary embodiments, implant 700 may be formed from only five components, namely, upper endplate 710, lower endplate 720, core 730, pin 740, and locking screw 750. However, other embodiments may have more or fewer components, and the list of components described above is not necessarily an exact and/or required list.

In operation, a surgeon may use an expansion tool to expand implant 700. For example, the expansion tool has corresponding end portions that engage the gripping notches 719, 729 and force the implant 700 open. Thereafter, and prior to fully tightening the locking screw 750, the implant 700 may naturally be biased toward the collapsed position as described above, but may be prevented from collapsing due to the engagement surfaces 716 and 726 and the locking screw 750. For example, at least one of the engagement surfaces 716, 726 may include a curved surface defined by a segment of a circle having a center point offset relative to the center point and/or an axis of extension of the pin 740. Thereafter, the end user may tighten the locking screw 750 such that the locking screw 750 applies a compressive force to the engagement surfaces 716 and 726, thereby pushing the upper end plate 710 and the lower end plate 720 against the core 730. For example, the locking screw 750 may apply a compressive force pushing the engagement surfaces 718, 728 into high friction engagement with the engagement surface 738. As used herein, the term "compressive force" does not necessarily require mechanical deflection, but rather pushes two objects into direct contact by an applied force.

Fig. 63 is a reference diagram showing a human spinal column in which various disclosed implant embodiments may be installed. Fig. 64 is a reference view of various planes and reference directions in which the various implant embodiments disclosed may be referenced to the patient 1 moving or acting.

It should be understood that the various aspects disclosed herein may be combined in different combinations than specifically presented in the specification and drawings. For example, features, functions, and components from one embodiment may be combined with another embodiment and vice versa, unless the context clearly indicates otherwise. Similarly, features, functions, and components may be omitted unless the context clearly indicates otherwise. It should also be appreciated that, depending on the example, certain acts or events of any of the processes or methods described herein can be performed in a different order, may be added, combined, or omitted entirely (e.g., not all of the described acts or events may be required to perform the techniques).

Unless specifically defined otherwise herein, all terms are to be given their broadest possible interpretation, including meaning as implied from the specification as well as meaning understood by one of ordinary skill in the art and/or as defined by dictionaries, papers, or the like. It must also be noted that, as used in the specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise, and the term "comprises" when used in this specification, specifies the presence of stated features, elements, and/or components, but does not exclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.

Claims

1. An expandable implant, the expandable implant being movable between a contracted position and an expanded position, the expandable implant comprising:

an inflatable body extending from a proximal end to a distal end in a proximal-to-distal direction and from a first lateral side to a second lateral side in a width direction, the inflatable body defined by hingedly connected upper and lower end plates;

the upper end plate includes a first core having a screw channel and a distal engagement surface;

the lower endplate includes a second core having a proximal engagement surface; and

a locking screw extendable through the first and second cores and movable between a locked position and an unlocked position,

wherein in the locked position, the locking screw urges the distal engagement surface of the first core against the proximal engagement surface of the second core.

2. The expandable implant according to claim 1, wherein:

the upper end plate includes a first clamping recess at a proximal end of the upper end plate; and is also provided with

The lower end plate includes a second clamping recess at a proximal end of the lower end plate.

3. The expandable implant according to claim 2, wherein:

the first clamping recess includes a groove having an upper curved surface and a lower curved surface; and is also provided with

The second clamping recess includes a groove having an upper curved surface and a lower curved surface.

4. The expandable implant according to claim 1, wherein:

the upper endplate includes a first plurality of engagement features at an angle of about 20 degrees to about 40 degrees relative to a proximal surface of the upper endplate; and is also provided with

The lower endplate includes a second plurality of engagement features that are angled from about 20 degrees to about 40 degrees relative to a proximal surface of the lower endplate.

5. The expandable implant according to claim 1, wherein:

the upper end plate further includes a channel located near the distal end and extending in the width direction; and is also provided with

The lower endplate further includes a rail located near the distal end and extending in the width direction, the rail having a size and shape generally corresponding to a size and shape of the channel and being located within the channel.

6. The expandable implant according to claim 5, wherein:

the distal engagement surface of the first core includes a first curved surface;

The proximal engagement surface of the second core includes a second curved surface; and is also provided with

The first curved surface is defined by a radius of a circle having a center point offset from the axis of rotation of the track.

7. The expandable implant according to claim 5, wherein:

the upper end plate including at least one hook adjacent the channel;

the lower end plate includes at least one relief adjacent the rail;

the at least one hook portion has a size and shape that generally corresponds to the size and shape of the at least one release portion; and is also provided with

The at least one hook is disposed within the at least one release.

8. The expandable implant of claim 7, wherein, in a cross-sectional view, the channel comprises an arcuate shape and the track comprises an arcuate shape.

9. The expandable implant according to claim 1, wherein:

the locking screw includes a threaded end and a drive feature separated by a fracture surface for separating the locking screw;

the first core is disposed proximally relative to the second core; and is also provided with

The locking screw is threadably engaged with at least one of the first core and the second core.

10. The expandable implant according to claim 1, wherein:

the locking screw extends in a proximal to distal direction along a longitudinal axis and is breakable into a proximal portion and a distal portion at a breaking surface; and is also provided with

When broken, the breaking surface is recessed relative to the sidewall of the locking screw.

11. A system including a medical implant and a surgical tool, the system comprising:

an expandable implant, the expandable implant being movable between a contracted position and an expanded position, the implant comprising:

the lower endplate includes a second core having a proximal engagement surface;

a locking screw movable between a locked position and an unlocked position;

wherein, in the locked position, the locking screw urges the distal engagement surface of the first core against the proximal engagement surface of the second core; and

A surgical tool for moving the implant from a contracted position to an expanded position and for moving the locking screw between the locked position and the unlocked position, the surgical tool being capable of moving the locking screw into the locked position while supporting the implant in the expanded position.

12. The system of claim 11, wherein:

the upper end plate includes a first clamping recess at a proximal end of the upper end plate;

the lower end plate includes a second clamping recess at a proximal end of the lower end plate;

the surgical tool includes a first clamping protrusion having a size and shape that generally corresponds to a size and shape of the first clamping recess; and is also provided with

The surgical tool includes a second clamping tab having a size and shape that generally corresponds to a size and shape of the second clamping recess.

13. The system of claim 12, wherein:

14. The system of claim 11, wherein the surgical tool comprises a pivot link assembly comprising a first arm and a second arm.

15. The system of claim 14, wherein the surgical tool comprises a body portion, a handle, and a third arm, the third arm being fixed relative to the body portion.

16. The system of claim 11, wherein the surgical tool further comprises:

a body portion having a bore extending therethrough;

a pivot link assembly including a first arm and a second arm;

a third arm fixed relative to the body portion;

an outer shaft extending through the body portion and having a drive feature at a distal end of the outer shaft for rotating the locking screw from the unlocked position to the locked position; and

an inner shaft extending through the outer shaft and having a first thread pattern at an end of the inner shaft for pulling the expandable implant toward the surgical tool.

17. The system of claim 16, wherein:

the locking screw includes a recessed fracture surface for separating the locking screw into a proximal portion and a distal portion,

the surgical tool is configured to separate the locking screw into the proximal portion and the distal portion when the implant is in the expanded position, and to retain the proximal portion of the locking screw via the inner shaft.

18. The system of claim 16, wherein the surgical tool further comprises an actuator for pivoting the pivot link assembly relative to the third arm to expand the implant.

19. The system of claim 11, wherein:

20. The expandable implant according to claim 19, wherein: