Patent Description:
The present inventions relate, in general, to surgical implant systems and methods of implanting same. More particularly, the present inventions relate to surgical implant systems including monolithic structures having an implant, a fixation member, and/or an instrument that are frangibly connected for separation during a surgical procedure.

Surgical implants often include several components. The implant itself may be comprised of different pieces, and is often secured to adjacent tissue by one or more additional fixation elements, such as screws or anchors. In addition, one or more instruments are typically needed during a surgical procedure to grasp and guide the implant and to place the fixation element(s) to secure the implant. The many components needed during one procedure can pose challenges for organization in the operating room, sterilization to prevent infection, and accuracy and efficiency in properly handling and placing the implant and fixation element(s) during a procedure. For instance, dropping or mishandling smaller screws can be a challenge during a procedure. This increases manufacturing costs as well as inventory of implants and instrumentation.

There is a need in the art for a surgical implant system that overcomes these drawbacks by simplifying surgical procedures and by making such procedures more efficient.

Documents <CIT>, <CIT> and <CIT> describe various implant systems.

The invention is disclosed in claim <NUM>, preferred embodiments being disclosed in the dependent claims.

A first aspect of the present disclosure is a surgical implant system that includes an implant, a fixation member for securing the implant to tissue, and an insertion instrument. The implant, the fixation member, and the insertion instrument together comprise a single monolithic structure.

In other aspects, the implant may be monolithically connected to the fixation member at a first frangible connection. The first frangible connection may be sheared through application of torque applied to the fixation member. The implant may be monolithically connected to the insertion instrument at a second frangible connection. The second frangible connection may be broken through application of a force applied to the insertion instrument. The implant may be one of a spinal implant, a cortical plate, and an acetabular cup.

The surgical implant system may be manufactured by three-dimensional (3D) printing. The surgical implant system may be manufactured by additive layer manufacturing. The system may be constructed of a single material.

A second aspect of the present disclosure is a surgical implant system that includes an implant and an insertion instrument. The implant and the insertion instrument together comprise a single monolithic structure.

In other aspects, the system may be constructed of a single material.

A third aspect of the present disclosure is a surgical implant system that includes an implant and a fixation member for securing the implant to tissue. The implant and the fixation member together comprise a single monolithic structure.

In other aspects, the surgical system may include an insertion instrument. The implant, the fixation member, and the insertion instrument together may comprise a single monolithic structure. The system may be constructed of a single material. The implant may be monolithically connected to the fixation member at a first frangible connection. The first frangible connection may be sheared through application of torque applied to the fixation member. The implant may be monolithically connected to the insertion instrument at a second frangible connection. The second frangible connection may be broken through application of a force applied to the insertion instrument. The implant may be one of a spinal implant, a cortical plate, and an acetabular cup. The implant system may be manufactured by <NUM>-D printing. The surgical system may be manufactured by additive layer manufacturing.

Another aspect of the present disclosure is a method of manufacturing a surgical implant system including constructing the surgical implant system by additive layer manufacturing to include an implant and a fixation member for securing the implant to tissue. The implant is monolithically connected to the fixation member at a first frangible connection, such that the implant and the fixation member together comprise a single monolithic structure.

In other aspects, the method may include the step of constructing the surgical implant to include an insertion instrument. The insertion instrument may be monolithically connected to the implant at a second frangible connection, such that the implant, the fixation member, and the insertion instrument together comprise a single monolithic structure.

Another aspect of the present disclosure is a method of manufacturing a surgical implant system that includes <NUM>-D printing the surgical implant system to include an implant, a fixation member for securing the implant to tissue, and an insertion instrument. The implant is monolithically connected to the fixation member at a first frangible connection and the implant is monolithically connected to the insertion instrument at a second frangible connection, such that the implant, the fixation member, and the insertion instrument together comprise a single monolithic structure.

In other aspects of the method, the step of <NUM>-D printing may include <NUM>-D printing the surgical implant system of a single material.

Yet another aspect of the present disclosure is a method of manufacturing a surgical implant system that includes constructing the surgical implant system by additive layer manufacturing to include an implant, a fixation member for securing the implant to tissue, and an insertion instrument. The implant is monolithically connected to the fixation member at a first frangible connection and the implant is monolithically connected to the insertion instrument at a second frangible connection, such that that the implant, the fixation member, and the insertion instrument together comprise a single monolithic structure.

In other aspects of the method, the step of constructing may include constructing the surgical implant system of a single material.

Yet another aspect of the present disclosure is a method of inserting a surgical implant system including implanting a single monolithic structure including an implant, a fixation member for securing the implant to tissue, and an insertion instrument. The implant is monolithically connected to the fixation member at a first frangible connection and the implant is monolithically connected to the insertion instrument at a second frangible connection. The method further includes applying a force to the fixation member to break the first frangible connection and applying a force to the insertion instrument to break the second frangible connection.

Another aspect of the present disclosure is a device for intervertebral disc repair that includes a spacer and a fixation member. The fixation member has an initial condition in which the spacer and the fixation member are monolithically connected and an operative condition in which the fixation member and spacer are separate and distinct.

In other aspects, the fixation member may have a screw having a central axis. The spacer may define an aperture for receiving the screw, the aperture having a perimeter at a location about a central axis of the aperture that is fully enclosed within the spacer. The central axis of the screw and the central axis of the aperture may extend through an anterior surface of the spacer at a non-perpendicular angle. The spacer may further define a second aperture for receiving a second screw, the second aperture defining a perimeter at a location about a central axis of the second aperture that is fully enclosed within the spacer. The second aperture may have a central axis. The central axis of the screw and the central axis of the second aperture may extend through an anterior surface of the spacer at a second non-perpendicular angle, the first and second non-perpendicular angles being different. The spacer may include a channel for receiving an anchor, the channel being a dovetail slot extending along a superior or an inferior surface of the spacer. The channel may extend between and intersect both an anterior surface and a posterior surface of the spacer. A perimeter of the channel about a central axis of the channel may not be fully enclosed within the spacer at a location about the central axis of the channel. The fixation member may be an anchor blade. The blade may be positioned relatively further from the posterior surface of the spacer when the blade is in the initial condition, and the blade may be positioned relatively closer to the posterior surface when the blade is in the operative condition.

Yet another aspect of the present disclosure is an intervertebral system including a spacer having a recess for receiving a bone anchor and a bone anchor frangibly coupled to the spacer and being movable relative to the spacer. The bone anchor has an initial position in which the bone anchor is positioned with a distal end of the anchor in the recess of the spacer and an operative position in which the anchor is positioned with at least a proximal end of the anchor in the recess. In the initial position the bone anchor and the spacer are monolithically connected.

In other aspects, movement of the bone anchor from the initial position to the operative position may engage the bone with the bone anchor to secure the spacer to an adjacent vertebra. The movement may include torque of the bone anchor.

Another aspect of the present disclosure is a device for intervertebral repair including a spacer having a posterior surface and an anterior surface and a bone anchor frangibly coupled to the spacer. The bone anchor has an initial position in which the bone anchor is relatively far from the posterior surface of the spacer and an operative position in which the bone anchor is relatively near to the posterior surface of the spacer. In the initial position the bone anchor is monolithically connection with the spacer. The device also includes an insertion instrument that has an initial condition in which the instrument is monolithically connected with the spacer and an operative condition in which the instrument is separate and distinct from the spacer.

In other aspects, in the initial condition the insertion instrument may be adapted to stabilize the device and/or drive the device into a disc space.

Yet another aspect of the present disclosure is a bone plating system including a plate having a recess for receiving a bone anchor and a fixation member movable relative to the plate. The fixation member has an initial position in which the fixation member is positioned with a distal end thereof in the recess of the plate and an operative position in which the fixation member is positioned with at least a proximal end thereof in the recess. The system includes an insertion instrument that has an initial condition in which the instrument is monolithically connected with the plate and an operative condition in which the instrument is separate and distinct from the plate. In the initial position, the fixation member and plate are monolithically connected.

Another aspect of the present disclosure is a device for intervertebral repair including a spacer having an anterior surface and an insertion instrument. The insertion instrument is frangibly coupled to the anterior surface of the spacer and has an initial condition in which the instrument is monolithically connected with the spacer and an operative condition in which the instrument is separate and distinct from the spacer.

Another aspect of the present disclosure is a method of using an intervertebral device including inserting the device into disc space, the device including a spacer, a bone anchor monolithically coupled to the spacer, and an insertion instrument monolithically coupled to the space; moving the bone anchor relative to the spacer, such that the bone anchor and the spacer become separate and distinct pieces; and bending the insertion instrument such that it breaks apart from the spacer.

In other aspects, the step of moving the bone anchor may engage the bone anchor to an adjacent vertebra. The step of moving the bone anchor may include rotating the anchor. The step of moving the anchor may include driving the anchor distally. The method may include the step of removing the insertion instrument from a patient.

A more complete appreciation of the subject matter of the present invention(s) and of the various advantages thereof can be realized by reference to the following detailed description in which reference is made to the accompanying drawings in which:.

In describing certain aspects of the present invention(s), specific terminology will be used for the sake of clarity. However, the invention(s) is not intended to be limited to any specific terms used herein, and it is to be understood that each specific term includes all technical equivalents, which operate in a similar manner to accomplish a similar purpose. In the drawings and in the description which follows, the term "proximal" refers to the end of the fixation members and instrumentation, or portion thereof, which is closest to the operator in use, while the term "distal" refers to the end of the fixation members and instrumentation, or portion thereof, which is farthest from the operator in use.

Referring to <FIG>, an intervertebral implant system <NUM> according to an embodiment of the present invention includes a monolithic device cast as a single piece including a spacer <NUM> frangibly connected with fixation members or screws <NUM> and an insertion instrument <NUM>. System <NUM>, including all components thereof, is made of a single material. A system in accordance with the present inventions can include a single fixation member or two or more fixation members depending on a particular procedure and/or the configuration of the associated implant. Although initially constructed as a single, continuous structure, implant system <NUM> includes frangible connections between spacer <NUM> and fixation members <NUM> and between spacer <NUM> and instrument <NUM>. The monolithic connection among the different components can be disconnected or broken after spacer <NUM> is positioned in an intervertebral disc space of the spine. While it will be discussed below that system <NUM> is produced through additive layer manufacturing (ALM), i.e. 3D printing, it is understood that the single, continuous or monolithic construct is created upon completion of the ALM process. The monolithic construction of system <NUM> is completed during a single process, which differentiates it from processes of separately manufacturing and later welding together the different components of system <NUM>. Alternate systems in accordance with the present inventions can include a monolithic device cast as a single piece including a spacer <NUM> frangibly connected with fixation members or screws <NUM> and omitting an instrument. Systems can also include a monolithic device cast as a single piece including a spacer <NUM> frangibly connected with an insertion instrument <NUM> and omitting fixation members.

As described more thoroughly below, implant system <NUM> is manufactured as a one-piece, integral construct with integrated fixation anchors/screws as well as integrated instrumentation to facilitate implantation. The preferred method of manufacturing system <NUM> is by utilizing 3D printing technology, which allows system <NUM> to be made monolithically with all features and components built into system <NUM> from the start. This improves handling of system <NUM> during implantation and can streamline the surgical procedure to make it more efficient. Notably, the initial construction and positioning of the fixation anchors/screws in system <NUM> eliminates the need for guides, such as screw guides, since the fixation elements are already in place for insertion once the main implant is finally seated. System <NUM> is fully ready to implant immediately out of its packaging, which minimizes steps for the surgeon and is designed to reduce complexity and increase operational efficiency. These benefits extend to all of the present embodiments, as well as to other types of surgical implant systems as contemplated by the present disclosure.

Spacer <NUM> includes a top or superior bone-contacting surface <NUM> and a bottom or inferior surface <NUM>, a posterior or leading surface <NUM>, an anterior or trailing surface <NUM> opposite leading surface <NUM>, and lateral surfaces <NUM> extending between the leading and trailing surfaces <NUM>, <NUM>. In the illustrated embodiment, spacer <NUM> has a generally rounded, oblong shape with lateral surfaces <NUM> being rounded. Alternatively, spacer <NUM> may be generally, square, rectangular, kidney, oval, circular, or other geometric shape in the superior view. Top and bottom surfaces or endplates <NUM>, <NUM> may be flat, concave, convex, or any other shape in the anterior or lateral views and may include teeth or ridges for more secure placement against endplates of the adjacent vertebrae. Endplates <NUM>, <NUM> can be porous to optimize bone growth/fusion. In particular, in a lateral view, top and bottom sides <NUM>, <NUM> may be curved or angled to give spacer <NUM> a lordotic shape. Hyperlordotic and double taper implants are also contemplated.

Spacer <NUM> further defines opening <NUM> extending from top surface <NUM> to bottom surface <NUM>. Opening <NUM> has a generally rounded, oblong shape and is surrounded by inner surface <NUM>. However, in other examples, opening <NUM> may have any shape or may comprise multiple openings. Opening <NUM> may allow for receipt of bone in-growth material, such as bone chips, autograft, allograft, Demineralized Bone Matrix (DBM), or synthetics.

Spacer <NUM> further includes two screws <NUM> positioned in respective holes <NUM>, the screws and holes each extending from trailing surface <NUM> to inner surface <NUM> and being spaced apart. Holes <NUM> and screws <NUM> each extend about a central axis that forms a non-perpendicular angle with trailing surface <NUM>. The angle of the screws and holes can vary as desired, and may be prepared such that the screws can reach the adjacent vertebral endplate to fix spacer <NUM> to the adjacent vertebra. Each hole <NUM> may be angled in a different direction from the other hole, and each screw <NUM> may be angled in a different direction from the other screw. However, in other examples, holes <NUM> may also extend about a central axis that is substantially perpendicular to trailing surface <NUM>. As shown in <FIG>, it is preferable that screws <NUM> are angled in opposite directions to engage both superior and inferior positioned vertebrae. Although the illustrated embodiment has two holes <NUM> and screws <NUM>, in other arrangements there may be more or less of the holes and screws.

As best shown in <FIG>, screws <NUM> are initially monolithically connected with spacer <NUM> and positioned such that the distal portion of the screw extends through inner surface <NUM>, a portion of the screw shaft being enclosed within hole <NUM> of spacer <NUM>, and the head and a portion of the shaft is positioned anteriorly external to trailing surface <NUM>. During a 3D printing procedure, spacer <NUM> and screws <NUM> are manufactured simultaneously with at least one frangible connection <NUM> therebetween. This connection can be a relatively thin layer of the material of spacer <NUM> and screws <NUM> that bridges or connects adjacent locations between spacer <NUM> and screws <NUM>. For example, as best shown in <FIG>, the frangible connection <NUM> is a radial flange of the material extending from the shaft or a thread on the shaft of screw <NUM> to a surface of hole <NUM>. This flange can be perpendicular to the screw axis or angled thereto. Of course, multiple connections <NUM> can be utilized and spaced apart about the circumference of screw <NUM>. A single connection <NUM> can also be employed. In other embodiments, an annular flange between spacer <NUM> and screws <NUM> can be provided via the material during 3D printing. In each case regardless of the geometry and location of the frangible connection, the material at the connection can be selectively constructed to break or shear upon a force applied to one of spacer <NUM> and screws <NUM>. That is, screws <NUM> can be torqued to advance them further into holes <NUM>. As screw <NUM> is torqued, the frangible connection between screw <NUM> and spacer <NUM> breaks such that screw <NUM> becomes a separate piece from spacer <NUM> and screw <NUM> is thereafter inserted further into hole <NUM> and ultimately into communication with an adjacent vertebra.

In the illustrated embodiment, there are two threaded screws <NUM>, angled in opposite directions; however, in other examples there may be more or less of screws <NUM> and the screws may be angled in different configurations. Screws <NUM> may include variable and/or fixed angle screws. Further, screws <NUM> may include self-drilling and/or self-tapping features to facilitate and minimize screw-hole preparation.

Spacer <NUM> further includes insertion instrumentation <NUM>. Instrument <NUM> includes shaft <NUM> extending from a distal end <NUM> to a proximal end <NUM>. Distal end <NUM> of shaft <NUM> is monolithically connected with and coupled to trailing surface <NUM> in a manner similar to the connection between spacer <NUM> and screws <NUM>. The monolithic construction of instrument <NUM> with spacer <NUM> is strong in both compression and tension forces. That is, the interface between instrument <NUM> and spacer <NUM> is such that it can withstand forces applied by a user during a surgical procedure without breaking. As instrument <NUM> is bent with respect to spacer <NUM>, it breaks off from spacer <NUM> and can be removed from the patient. Distal end <NUM> may be tapered, as in <FIG>, or it may be straight. The taper can be configured to facilitate the ultimate breakage between instrument <NUM> and spacer <NUM>. In some cases, the taper or the connection in general can be manufactured to be stronger in some planes as opposed to others. That is, it may be easier to bend instrument <NUM> with respect to spacer <NUM> at particular angles.

Shaft <NUM> extends generally orthogonally to trailing surface <NUM> and extends in an anterior direction from the spacer <NUM>. Further, instrument <NUM> extends generally parallel to upper and lower surfaces <NUM>, <NUM>, but in other examples, the instrument may extend in an angled direction, either superiorly, inferiorly, or laterally to spacer <NUM>. Proximal end <NUM> of shaft <NUM> may include raised portion <NUM> for easier gripping. Raised portion <NUM> may further include an attachment mechanism to attach to a separate handle such as a quick connect handle (not shown), if further length of insertion instrument <NUM> is required during a procedure. However, in other examples, shaft <NUM> may be flat and may not include a raised portion. In some embodiments, instrument <NUM> may be used as a driver to drive one or more of screws <NUM> into their fully inserted positions after instrument <NUM> is separated from spacer <NUM>.

<FIG> depict an intervertebral implant system <NUM>' according to another embodiment of the present invention. Implant system <NUM>' has similar features to those described above in connection with implant system <NUM>. Screws <NUM>' are initially monolithically connected to spacer <NUM>' by frangible connection <NUM>' that is constructed to break or shear upon a force applied to one of spacer <NUM>' and screws <NUM>'. In the illustrated embodiment, frangible connection <NUM>' is similar to frangible connection <NUM> of spacer <NUM> and is a radial flange of the material extending from the shaft or a thread on the shaft of screw <NUM>' to a surface of hole <NUM>'. In other arrangements, the frangible connection <NUM>' can be configured with different geometries, including an annular flange, and one or more connections <NUM>' can be employed.

Screws <NUM>' each include a locking mechanism <NUM>' to secure the screws within spacer <NUM>' after implantation. As best shown in <FIG>, locking mechanism <NUM>' is located on the head of each screw <NUM>' and includes flange <NUM>' extending further radially outward from the rest of the head of screw <NUM>'. Flange <NUM>' has an outwardly extending protrusion which, when it contacts an inner surface of hole <NUM>', causes flange <NUM>' to flex inward toward screw to produce a friction fit between the head of screw <NUM> and hole <NUM>'. Holes <NUM>' may also include a groove (not shown) for flange <NUM>' to snap into. Flange <NUM>' is provided to inhibit backout of screw <NUM>' once it is inserted into spacer <NUM>'. Other types of known anti-backout mechanisms, such as split rings, spring bars, washers, rotatable cover plates, etc., can also be used. Snap fits, cover plates, and/or other compression technology known in the art may be used.

A method of implanting intervertebral implant systems <NUM>, <NUM>' in the lumbar spine from an anterior surgical approach will now be described with reference to system <NUM>. At least a portion of an intervertebral disc between adjacent vertebrae is removed using tools and techniques known in the art. Intervertebral implant system <NUM> is provided in a sterile kit. Once removed from the packaging, instrument <NUM> is connected with a quick connect handle. In some instances, a tube can be inserted over instrument <NUM> for added stability during insertion. Spacer <NUM> and screws <NUM> are then inserted into the prepared disc space using insertion instrument <NUM>. This can include impacting a proximal end of instrument <NUM>. Once spacer <NUM> is located in the disc space, the surgeon can use instrument <NUM> to manipulate and stabilize spacer <NUM> in the desired location.

The surgeon then torques each of screws <NUM> with a driver, such as by manually driving the screw or using a power driver, such that attachment between the screws and spacer <NUM> is sheared. Screws <NUM> continue to be torqued and rotated into engagement with the respective vertebrae. Because the screws are already angled within spacer <NUM>, the screws are positioned having the appropriate and correct trajectory into the bone. After the implant <NUM> is secured within the bone, the surgeon may then cantilever and break off instrument <NUM>. Breaking off instrument <NUM> may allow for a flat surface, such that the break is clean without leaving any sharp edges. Instrument <NUM> is then removed from the patient. In certain embodiments, removal of instrument <NUM> can be done at an earlier stage so that it can be used as a driver for one or more screws <NUM>. A separate mechanism for preventing backing out of screws <NUM> may then be attached to the implant, if desired.

It will be understood that the same or similar methods may be employed to install the implant system <NUM> at any level of the spine, and from any surgical approach, including lateral, without departing from the scope of the present invention. More specifically, it is contemplated that implant system <NUM> may be implanted from an anterior, posterior, posterior-lateral, lateral, or other surgical approach.

<FIG> depict an intervertebral implant system <NUM> according to an embodiment of the present invention. Implant system <NUM> includes spacer <NUM>, fixation members or anchor blades <NUM> and insertion instrument <NUM>. Spacer <NUM> includes top and bottom surfaces <NUM>, <NUM>, respectively, leading surface <NUM>, a trailing surface <NUM> opposite leading surface <NUM>, and lateral surfaces <NUM> extending between the leading and trailing sides <NUM>, <NUM>. In the illustrated embodiment, spacer <NUM> has a generally rounded, oblong shape with lateral surfaces <NUM> being rounded. Alternatively, spacer <NUM> may be generally, square, rectangular, kidney, oval, circular, or other geometric shape in the superior view. Top and bottom surfaces <NUM>, <NUM> may be flat, concave, convex, or any other shape in the anterior or lateral views and may include teeth or ridges for more secure placement against endplates of the adjacent vertebrae. In particular, in a lateral view, top and bottom surfaces <NUM>, <NUM> may be curved or angled to give spacer <NUM> a lordotic shape.

Spacer <NUM> further includes channels or tracks <NUM> that extend across spacer <NUM> between and intersect with both leading side <NUM> and trailing side <NUM>. As shown in <FIG>, channels <NUM> are dovetail slots that are formed in spacer <NUM> in a truncated I-beam shape. However, in other examples, the channels <NUM> may have a variety of shapes, including circular, rectangular, keyhole, T-shaped, etc. Each channel is preferably configured to have an enlarged profile away from the adjacent surface so that an anchor disposed therein can be secured from migrating out of that channel toward the surface. Each dovetail slot is configured to slideably engage with a mating feature on an anchor <NUM>, described in detail below. Spacer <NUM> includes two channels, one channel <NUM> that is open toward top surface <NUM> of the spacer and extends across top surface <NUM>, and one channel <NUM> that is open toward bottom surface <NUM> of the spacer and extends across bottom side <NUM>. Although in other examples, there may be more or less of channels <NUM>.

As shown in <FIG>, each channel <NUM> may extend about a central axis that is perpendicular to leading surface <NUM>. However, in other examples, the central axis of the channels may be angled, i.e. forms a non-perpendicular angle, with respect to leading surface <NUM>. Channels <NUM> may extend across top and bottom surfaces <NUM>, <NUM> along an axis that extends straight through spacer <NUM> from trailing surface <NUM> to leading surface <NUM>. Although, in other examples, the channels may be configured to extend from trailing surface <NUM> to leading surface <NUM> in a variety of angles. Further, each channel <NUM> may have a perimeter about its central axis that is not fully enclosed within spacer <NUM> at any location along its central axis so that it is open in the superior or inferior direction, as the case may be.

Spacer <NUM> further includes openings <NUM>, <NUM> extending from top surface <NUM> to bottom surface <NUM> and positioned on lateral sides of channels <NUM>. Openings <NUM>, <NUM> are surrounded by inner surfaces <NUM> and are shaped as semi-ovals; however, in other examples, the openings may be shaped as generally circular, rectangular, or any other shape. Openings <NUM>, <NUM> may allow for receipt of bone in-growth material. Additionally, instrument <NUM> is similar to instrument <NUM> and functions in the same manner.

Anchor blades <NUM> are used as a fixation method with spacer <NUM>. Anchor <NUM> may include an interconnection portion <NUM> extending between leading end and trailing ends <NUM>, <NUM>. Interconnection portion <NUM> is shaped and sized to matingly attach with the channels <NUM> of spacer <NUM>. In the present embodiment, the interconnection portion is a dovetail beam <NUM> that can slideably attach to the plates and spacers.

Anchor <NUM> can include a stop feature, such as a flange, near trailing end <NUM> to prevent the anchor from migrating too far posteriorly into prosthesis <NUM> after implantation. Anchor <NUM> can further include a locking feature, such as a flexible tab disposed near the trailing end <NUM> of the dovetail beam <NUM>, to prevent the anchor from migrating anteriorly after implantation. The stop feature and the flexible tab can cooperate with spacer <NUM> to maintain anchor <NUM> in its implanted position in the spacer. Anchor <NUM> also includes a fixation portion <NUM> that secures anchor <NUM> to an adjacent vertebra. Fixation plate <NUM> may be sharpened around a portion of its profile to create a cutting edge to cut through bone. The anchors and other aspects of system <NUM> are further disclosed in <CIT>, and titled "Intervertebral Implant With Integrated Fixation.

As shown in <FIG>, anchors <NUM> are each positioned with a portion of interconnection portion <NUM> inserted in and frangibly attached to channel <NUM>. This can be done during a 3D printing procedure by including at least one frangible connection <NUM> between anchor <NUM> and spacer <NUM>. In the illustrated embodiment, frangible connection <NUM> is a flange of the material extending from interconnection portion <NUM> to channel <NUM> that bridges the anchor and the spacer. This flange can be perpendicular to the interconnection portion axis or angled thereto. Multiple connections <NUM> can be utilized and spaced apart about the interconnection portion <NUM>. However, a single connection <NUM> can also be employed. Once the frangible connection is broken between spacer <NUM> and interconnection portion <NUM>, the interconnection portion can slide within channel <NUM> without interference. The surface area of the connection can be small enough so that the connection shears upon a force applied to the proximal end of anchor <NUM>, but large enough to withstand typical forces that may be applied, purposefully or incidentally, to anchor <NUM> during initial insertion of spacer <NUM>. In other arrangements, the frangible connection can be between the bottom surface of leading end <NUM> of interconnection portion <NUM> and the adjacent bottom surface of channel <NUM>.

After inserting the implant system into the prepared disc space, anchors <NUM> can be driven into the bone, such as by manually driving anchors <NUM> or using a pneumatic driver, such that the blade slides into position further distally within channel <NUM> and the monolithic attachment of the anchors with spacer <NUM> is broken. As a result, a proximal portion near trailing end <NUM> of anchor <NUM> is closer to trailing side <NUM> and within channel <NUM>.

Although described above with reference to illustrated anchor <NUM>, other embodiments of anchor blades work in conjunction with implant system <NUM>. Any sort of staple, blade, or anchor that is eventually inserted into connection with spacer <NUM> and one or more adjacent vertebrae can be 3D printed and frangibly connected in the manner discussed above. Additionally, a spacer may be configured such that it includes both screw fixation members and blade fixation members. In this manner, a spacer similar to spacer <NUM> may include screws similar to screws <NUM> or screws <NUM>'. The screws may be located on either side of instrument <NUM> on trailing surface <NUM>. Further, the screws may be angled, such that one screw extends superiorly and the other screw extends inferiorly. Both the blades and screws may be formed monolithically with the spacer or one fixation mechanism, such as one of the screws and blades, may be monolithic, while the spacer is designed to allow for insertion of the non-monolithic, standalone fixation component.

Implant systems <NUM>, <NUM>', and <NUM>, as well as others according to the present inventions, may include one or more radiographic markers on the top surfaces of spacers <NUM>, <NUM>', and <NUM> (not shown). Additionally, the spacers may include serrations on various surfaces, i.e. top and bottom surfaces, to allow for fixation with adjacent vertebrae.

Although shown as anterior implants, intervertebral systems <NUM>, <NUM>', <NUM> may be configured and dimensioned for lateral spinal surgery. In this manner, the system, in particular spacers <NUM>, <NUM>', <NUM> may have dimensions that are greater in the medial-lateral direction and lesser in the anterior-posterior direction as compared to spacer <NUM>, <NUM>', <NUM>.

In other embodiments, spacers <NUM>, <NUM>', <NUM> may include an attachment mechanism to allow for attachment of a retaining mechanism or plate at trailing surface <NUM>. The retaining mechanism may include clips, positioned for example on a top surface, bottom surface, and/or lateral surfaces to attach to fit into recesses in corresponding locations on spacer <NUM>. Such retaining mechanisms are disclosed in <CIT>, and titled "Retaining Mechanism, Implant, and Tool," and <CIT>, and titled "Spinal Implant System.

A method of implanting intervertebral implant system <NUM> in the lumbar spine from an anterior surgical approach includes first removing at least a portion of an intervertebral disc between adjacent vertebrae. Intervertebral implant system <NUM>, provided in a sterile kit and including spacer <NUM>, anchor blades <NUM>, and instrument <NUM>, is then inserted into the prepared disc space using insertion instrument <NUM> for manipulation. Once spacer <NUM> is in the disc space, the surgeon can use instrument <NUM> to stabilize the spacer <NUM> in the desired location. The surgeon then drives anchor blades <NUM> in a posterior direction to engage the adjacent vertebrae using guiding instruments, which can be equipped to handle impaction during the insertion. In doing so, the attachment between anchors <NUM> and spacer <NUM> is sheared and anchors <NUM> are moved into full connection with spacer <NUM> and the respective vertebrae. After implant <NUM> is secured within the bone, the surgeon may then break off instrument <NUM>. Breaking off instrument <NUM> may allow for a flat surface, such that the break is clean. Instrument <NUM> is then removed from the patient. A mechanism for preventing backing out of anchors <NUM>, such as a cover plate, may optionally be attached to implant.

<FIG> shows a spinal fusion plate system <NUM> according to an embodiment of the invention that may be used to stabilize or fuse vertebral bodies of the spine. The system is configured to span across and fixate at least two vertebrae of the spine. The system comprises a plate <NUM> having screws <NUM> extending into the plate and instrumentation <NUM>. Plate <NUM> includes an upper surface or anterior surface <NUM> facing the patient's soft tissue when installed and a lower surface or posterior surface <NUM> facing the vertebral bodies to be immobilized. The upper surface <NUM> and lower surface <NUM> are interconnected by curved side walls and end walls to form a generally rectangular shape that is symmetrical about a midline. The gently curved structure of plate <NUM> complements the natural curved structure of the vertebral bodies and lordotic curvature of the spine. The corners of the plate are rounded to reduce irritation of the surrounding tissue. Plate <NUM> has a low profile to minimally impinge on adjacent tissue.

Plate system <NUM> further includes screws <NUM> similar to screws <NUM> and including a locking feature <NUM> similar to locking feature <NUM>'. Screws <NUM> are initially monolithically connected to spacer <NUM> by frangible connection <NUM>, similar to frangible connection <NUM> of spacer <NUM>. Connection <NUM> is constructed such that it can break or shear upon a force applied to one of spacer <NUM> and screws <NUM>. In the illustrated embodiment, there are multiple connections <NUM> each extending from screw <NUM> to an inner surface of hole <NUM>. In other arrangements, more or less frangible connections having the same or different configurations can be employed, as described above.

In the illustrated embodiment, four screws <NUM> are positioned within holes <NUM>, the screws and holes extending from upper surface <NUM> to lower surface <NUM>. Screws <NUM> may be fixed and/or variable angle screws. Screws <NUM> are spaced apart and each one is positioned near a curved corner of plate <NUM>. Opening <NUM> is positioned generally centrally on plate <NUM> and extends from upper surface <NUM> to lower surface <NUM>. Opening <NUM> reduces the overall weight of plate <NUM> and provides a visualization pathway to monitor bone graft progress between the vertebral bodies. Screws <NUM> are frangibly connected with plate <NUM> in a manner similar to screws <NUM> with spacer <NUM>.

Plate system <NUM> further includes instrument <NUM> similar to instrument <NUM> of implant system <NUM>. The frangible connection between plate <NUM> and instrument <NUM> is similar to that of spacer <NUM> and instrument <NUM>. Instrument <NUM> is positioned on upper surface <NUM> and extends anteriorly away from the upper surface. Instrument <NUM> may be positioned in between two screws <NUM> or in any location on plate <NUM> where it can be used for manipulation of plate <NUM> by a user without interfering with the manipulation of screws <NUM>.

A method of implanting bone plate system <NUM> includes placing plate <NUM> adjacent to a vertebral column using instrument <NUM> as a guide and/or handle for insertion. The placement of the plate <NUM> relative to the vertebral bone in a patient may be determined based on a pre-operative examination of the patient's spine using non-invasive imaging techniques known in the art. Any additional preparation may be done around the desired vertebrae prior to positioning plate <NUM>. Once plate <NUM> is appropriately positioned, screws <NUM> are torqued, such that the attachment of screws <NUM> with plate <NUM> is sheared. Screws <NUM> are further torqued to engage the bone. After plate <NUM> is secured, instrument <NUM> is broken off from the implant.

<FIG> depict a prosthetic acetabular cup implant system <NUM> according to an embodiment of the present invention. Implant system <NUM> includes an acetabular cup <NUM> and screw <NUM> positioned in hole <NUM>. Screw <NUM> is frangibly connected with cup <NUM> by frangible connections <NUM> in a manner similar to screws <NUM> with spacer <NUM>. In the illustrated embodiment, each frangible connection <NUM> is radial flange of the material extending from the shaft or a thread on the shaft of screw <NUM> to a surface of hole <NUM>. The flange can be perpendicular to the screw axis or angled thereto. Although shown as having more than one connection <NUM>, the system <NUM> may include a single connection, such as a single annular connection.

Acetabular cup <NUM> is a part-spherical cup adapted for location in an acetabulum and having a rounded outer surface <NUM> and an inner bearing surface <NUM> to receive a bearing liner and a part-spherical ball head which can be attached to a prosthetic stem for location in a femur. Acetabular cup further defines an opening <NUM> due to the semispherical shape of the cup. Acetabular cup <NUM> further includes flat surface or rim <NUM> extending between outer surface <NUM> and inner surface <NUM>.

Hole <NUM> and screw <NUM> extend along a central axis from inner surface <NUM> to outer surface <NUM>. In the illustrated embodiment, there is one screw <NUM> located generally centrally at a midpoint of acetabular cup <NUM>. Screw <NUM> is formed monolithically with acetabular cup <NUM>. Screw <NUM> is initially positioned such that a portion of the screw shaft is enclosed within acetabular cup <NUM> and the tip extends proximally from the acetabular cup. Further, the head of the screw is positioned within opening <NUM>.

In the illustrated embodiment, screw <NUM> is similar to screw <NUM>, but implant system <NUM> can also include a screw similar to screws <NUM>', in which a locking mechanism is including within the screw and/or hole to secure the screw within acetabular cup <NUM>. Additionally, although the illustrated embodiment there is only one screw <NUM>, the system may include multiple screws <NUM> and holes <NUM> spaced apart on acetabular cup <NUM>. It is also contemplated that an instrument like instrument <NUM> be connected with a portion of cup <NUM>, such as rim <NUM> so as not to interfere with bearing surface <NUM>. However, this highlights that systems in accordance with the present invention can be provided with just an implant and fixation member(s), and without an insertion instrument. Likewise, an insertion instrument can be provided in a system with an implant but without fixation members if none are applicable or desired.

A method of implanting hip implant system <NUM> includes preparing an acetabulum for insertion of implant system <NUM>. Cup <NUM> is then inserted into the patient, and screw <NUM> is torqued. The torque shears the attachment of screw <NUM> with cup <NUM>. Screw <NUM> is torqued further such that it engages the bone to provide securement of the implant to the bone.

Implant systems in accordance with the present inventions are formed using three-dimensional (3D) printing to produce a monolithic structure comprised of a spacer, one or more fixation members, and/or an insertion instrument, the fixation members and instrument being frangibly coupled to the spacer. The implant system does not experience any additional fixation process to provide for the monolithic construction and as such the monolithic connection is not the result of welding, fusing, cement, or any similar process beyond the particulars of the ALM process used during construction. The systems can be comprised of a porous metal or can have a solid internal core with a porous metal surface such as a porous titanium alloy, including Tritanium® by Howmedica Osteonics Corporation. The implant systems may be comprised of metal, such as titanium, ceramic, glass, polymer, or any other material known for use in the human body and capable of utilization in a 3D printing technique. The implant systems may also comprise one or more surface treatments to encourage bony attachment, such as porous coating, plasma spray coating, hydroxyapatite, or tricalcium phosphate.

In preferred arrangements, any of the present implants systems can be formed, at least in part, in a layer-by layer fashion using an additive layer manufacturing (ALM), i.e. 3D printing, process using a high energy beam, such as a laser beam or an electron beam. Such ALM processes may be but are not limited to being powder-bed based processes including but not limited to selective laser sintering (SLS), selective laser melting (SLM), and electron beam melting (EBM), as disclosed in <CIT> and <CIT>, or other ALM processes such as but not limited to powder-fed based processes including but not limited to fused filament fabrication (FFF), e.g., fused deposition modeling (FDM).

The implants and systems may be constructed of porous geometries which have been digitally modeled using unit cells, as further described in <CIT> and <CIT>. A first layer or portion of a layer of powder is deposited and then scanned with a high energy beam to create a portion of a plurality of predetermined unit cells. Successive layers of powder are then deposited onto previous layers of the powder and also may be individually scanned. The scanning and depositing of successive layers of the powder continues the building process of the predetermined porous geometries. As disclosed herein, by continuing the building process refers not only to a continuation of a porous geometry from a previous layer but also a beginning of a new porous geometry as well as the completion of a porous geometry. The porous geometries of the formed porous layers may define pores that may be interconnecting to provide an interconnected porosity. Of course, implants can also be made to be solid with or without porous portions.

In accordance with the present teachings, frangible fixation members and/or insertion instruments may be used for other prosthetic implants throughout the body. The present invention is not limited to any particular type of implant and is not limited to surgical applications. For example, it is contemplated that the present invention can be implemented in different spinal implants, such as the implants disclosed in <CIT>, and titled "Spinal Implant with Porous and Solid Surfaces. Moreover, other areas and uses may include unicompartmental knee replacement implants, bicompartmental knee replacement implants, tricompartmental knee replacement implants, total knee replacement implants, patellofemoral replacement implants, shoulder implants, hip implants, cortical and spinal plates, base plates, etc. An implant in accordance with the present application can be a patient-specific implant generated from CAD files, for example, so that it is unique for a particular patient and application. Other nonsurgical applications are also contemplated. For example, an L bracket may be monolithically formed with a screw using additive layering manufacturing, as described above. This arrangement can be used to insert a screw into a wall. The screw may be frangibly connected to the L bracket such that torqueing the screw breaks the connection with the L bracket.

Claim 1:
A surgical implant system comprising:
an implant (<NUM>, <NUM>, <NUM>, <NUM>) having a hole (<NUM>, <NUM>, <NUM>) or a channel (<NUM>); and
a fixation member (<NUM>, <NUM>, <NUM>, <NUM>) for securing implant to a tissue,
wherein in an initial condition, the implant (<NUM>, <NUM>, <NUM>, <NUM>) and the fixation member (<NUM>, <NUM>, <NUM>, <NUM>) together comprise a single monolithic structure, characterized in that in an operative condition, the fixation member (<NUM>, <NUM>, <NUM>, <NUM>) and implant (<NUM>, <NUM>, <NUM>, <NUM>) are separate and distinct and the fixation member (<NUM>, <NUM>, <NUM>, <NUM>) is positioned in the hole (<NUM>, <NUM>, <NUM>) or channel (<NUM>).