JP7457750B2 - Implants with diagonal insertion axis - Google Patents

Description

FIELD OF THE INVENTION The present invention generally relates to implants that support bone growth in a patient.

A variety of different implants are used in the body to stabilize an area and encourage bone ingrowth. Implants used in the body provide both stability (i.e. minimal deformation over time under pressure) and space for bone ingrowth.

Spinal fusion, also known as spinal fusion or spinal fusion, can be used to treat a variety of conditions, such as degenerative disc disease, spondylolisthesis (slipped vertebrae), spinal stenosis, scoliosis, fractures, infections or tumors. It is a surgical procedure used to treat a medical condition. The purpose of spinal fusion procedures is to reduce instability and thus pain.

Most of the discs are removed in preparation for spinal fusion. Implants, or spinal fusion cages, are placed between the vertebrae to maintain spinal alignment and disc height. Fusion (ie, a bony bridge) occurs between the endplates of the vertebrae.

US Patent Application Publication No. 2018/0110626 US Patent Application Publication No. 2017/0042697 US Patent Application Publication No. 2018/0256351 US Patent Application Publication No. 2016/0324656 US Patent Application Publication No. 2018/0256352 US Patent Application Publication No. 2018/0256353 US Patent Application Publication No. 2018/0256361 US Patent Application Publication No. 2018/0296347 US Patent Application Publication No. 2018/0296350

In one aspect of the invention, the implant includes a body portion configured with a peripheral structure, and the body portion further includes an opening for receiving a portion of an insertion device. The implant also includes a plurality of bone contacting elements attached to the body. The peripheral structure further includes a first outer section, a second outer section, a front section, and a rear section. The first outer portion and the forward portion are connected at a first corner portion of the surrounding structure, and the second outer portion and the rear portion are connected at a second corner portion of the surrounding structure. There is. The opening is located at a first corner portion of the peripheral structure.

In another aspect, the implant includes a body portion comprised of a peripheral structure and a support beam. The implant also includes a plurality of bone contacting elements attached to the body. The peripheral structure further includes a first outer section, a second outer section, a front section, and a rear section. The first lateral portion and the front portion are connected at a first corner portion of the peripheral structure, and the second lateral portion and the rear portion are connected at a second corner portion of the peripheral structure. The support beam has a first end attached to a first corner portion of the surrounding structure, and the support beam has a second end attached to a second corner portion of the surrounding structure.

In another aspect, an implant includes a body configured with a surrounding structure and a plurality of bone contacting elements attached to the body. The peripheral structure further includes a first outer section, a second outer section, a front section, and a rear section. The first outer portion and the front portion are connected at a first corner portion of the peripheral structure, and the second outer portion and the rear portion are connected at a second corner portion of the peripheral structure. The second outer portion and the front portion are connected by a third corner portion of the peripheral structure, and the first outer portion and the rear portion are connected by a fourth corner portion of the peripheral structure. The plurality of bone contacting elements exhibit a curved surface on the upper side of the device, the curved surface curving from the third corner to the fourth corner.

Other systems, methods, features and advantages of the present embodiments will be or will become apparent to those skilled in the art upon consideration of the following drawings and detailed description of the invention. It is intended that all such additional systems, methods, features and advantages be included within this specification and summary, be within the scope of the embodiments, and be protected by the following claims. intended.

The present embodiments can be better understood with reference to the following drawings and description. The components in the drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the embodiments. Also, in the drawings, like reference numerals represent corresponding parts throughout the various figures.

1 is a schematic isometric view of an embodiment of an implant; FIG. 1 is a schematic isometric view of an embodiment of an implant; FIG. 1 is a schematic isometric view of an embodiment of an implant; FIG. FIG. 2 is a schematic top view showing the main body of the implant. Figure 5 is a schematic isometric view of the body of the implant of Figure 4; FIG. 1 is a schematic front view showing an embodiment of an implant. It is a typical rear view showing an embodiment of an implant. FIG. 3 is a schematic illustration of an arcuate bone contacting element including several exemplary schematic cross-sections; FIG. 2 is a schematic diagram of an implant including an enlarged schematic view of the attachment area between an exemplary arcuate bone contacting element and a portion of the body of the implant. FIG. 2 is a schematic top view of the implant of FIG. 1; FIG. 7 is a schematic top view showing another embodiment of the implant. Figure 3 is a schematic isometric view of another embodiment of the implant; FIG. 13 is a schematic top view of the implant of FIG. 12. FIG. 1 is a schematic isometric view of an embodiment of an implant including a roughened surface. FIG. 2 is a schematic illustration of an exemplary roughened surface area. FIG. 1 is a schematic diagram depicting a patient undergoing an exemplary anterolateral interbody fusion procedure. FIG. 1 is a schematic illustration of a portion of an exemplary spine. 1 is a schematic isometric view of an exemplary implant embodiment; FIG. FIG. 17 is a schematic diagram showing an embodiment of the implant of FIG. 16; Figure 17 is a schematic illustration of the embodiment of the implant of Figure 16 with the threaded cavity visible; FIG. 17 is a schematic diagram showing an embodiment of the implant of FIG. 16; 19 is a schematic illustration of the implant of FIG. 18 with a curved surface showing a convex geometry of the upper side of the implant; FIG. FIG. 19 is a schematic diagram of the implant of FIG. 18 showing the convex geometry of the upper and lower sides; 19 is a schematic diagram of the implant of FIG. 18, including an enlarged schematic view of some of the bone contacting elements; FIG.

Embodiments of the invention described herein relate to implants for use in the spine. The embodiments include implants having a body portion and one or more arcuate bone contacting elements.

In addition to the various measures described below, any of the embodiments disclosed herein are described in "Implant with Protected" by McShane III et al., which is hereby incorporated by reference in its entirety. of the body/support structure, frame, plate, coil or other structure disclosed in US Pat. Any one may be used (proxy reference number 138-1007).

Any of the embodiments disclosed herein may also be described in "Implant with Arched Bone Contacting Elements" by McShane, III et al., which is hereby incorporated by reference in its entirety. Utilizing any of the body/support structures, elements, frames, plates or other structures disclosed in US Pat. (Agent reference number 138-1009).

Any of the embodiments disclosed herein may also be described in the "Implant Application" by McShane III et al., which is hereby incorporated by reference as the "Ring Application" in its entirety. Body/Support Structure, Elements and Frame as disclosed in US Pat. , plates or other structures may be utilized (Deputy Docket No. 138-1012).

Any embodiments may also be described in detail in Morris et al., entitled "Coiled Implants and Systems and Methods of Use Thereof," which is hereby incorporated by reference in its entirety. Additionally, any of the body/support structures, frames, plates, or other structures disclosed in US Pat. For convenience, the Morris application is referred to throughout this application as the "Coiled Implant Application" (Attorney Docket No. 138-1024).

Any of the embodiments disclosed herein may also be described in "Implant with Bone Contacting Elements Having Helical and Undulating Planar Geometries" by Nyahay et al., which is hereby incorporated by reference in its entirety. s (spiral) A body/support structure, element, frame, plate or other body/support structure, element, frame, plate or other Any of the structures may be utilized (Agent Docket No. 138-1037).

Additionally, any of the embodiments disclosed herein may utilize any of the body/support structures, elements, frames, plates, or other structures disclosed in U.S. Patent Application Publication No. 2013/0133639, entitled "Corpectomy Implant," to Nyahay et al., published September 13, 2018 (Attorney Docket No. 138-1042), which is incorporated herein by reference in its entirety.

Additionally, any of the embodiments disclosed herein may utilize any of the body/support structures, elements, frames, plates, or other structures disclosed in U.S. Patent Application Publication No. 2015/0139999, entitled "Implant with Supported Helical Members," to Bishop et al., which is incorporated herein by reference in its entirety (Attorney Docket No. 138-1043).

Any of the embodiments disclosed herein may also be described in detail in Hamzey et al.'s "Implant with Curved Bone Contacting Elements", which is hereby incorporated by reference in its entirety. Any of the body/support structures, elements, frames, plates or other structures disclosed in US Pat. (Agent docket number 138-1059).

Any of the embodiments disclosed herein may also be described in detail in Hamzey et al. Utilizing any of the body/support structures, elements, frames, plates or other structures disclosed in US Pat. Moyoi (proxy docket number 138-1067).

<Overview of implants>
1-3 show isometric views of an embodiment of an implant 100. The implant 100 may also be referred to as a cage or fixation device. In some embodiments, the implant 100 is configured to be implanted within a portion of the human body. In some embodiments, the implant 100 may be configured for implantation into the spine. In some embodiments, the implant 100 may be a spinal fixation implant or device that is inserted between adjacent vertebrae to provide support between the vertebrae and/or to facilitate fusion between the vertebrae.

In some embodiments, implant 100 includes a body portion 102. In some embodiments, implant 100 includes a body portion 102. Body portion 102 may generally provide a frame or scaffold for implant 100. In some embodiments, implant 100 may also include multiple arcuate contact elements 104. The plurality of arcuate contacting elements 104 may be attached to and/or continuously formed (or “integrally formed”) with the body portion 102 .

As used herein, each arcuate contacting element includes features or elements that span a region or area of the implant. In some embodiments, these elements may overlap or intersect, similar to elements in a lattice or other 3D mesh structure. In other embodiments, the elements may not overlap or intersect. In some embodiments, elements may be used in which the length of the element is greater than its width and its thickness. For example, in embodiments in which the element has a generally circular cross-sectional shape, the element has a length greater than its diameter.

In the embodiments seen in FIGS. 1-3, each arcuate bone contacting element has a generally round or circular cross-sectional shape along at least a portion of the element (i.e., the element has a solid tube geometry). ). However, in other embodiments, the elements can have any other cross-sectional shapes, including various polygonal cross-sectional shapes, as well as any other regular and/or irregular cross-sectional shapes. However, it is not limited to these. In some cases, for example, the cross-sectional shape of the arcuate bone contacting element could vary along its length (e.g., the diameter or shape could vary along its length). ).

For clarity, various directional adjectives are referred to in the detailed description and claims. As used herein, the term "anterior" refers to the side or portion of the implant that is intended to face toward the front of the body when the implant is placed in the body. Similarly, the term "posterior" refers to the side or portion of the implant that is intended to face toward the back of the body after implantation. Also, the term "upper" refers to the side or portion of the implant that is intended to face toward the top of the body (e.g., the head), while "lower" refers to the side or portion of the implant that is intended to face toward the bottom of the body. Reference is also made herein to the "outer" side or portion of the implant, which is the side or portion that faces toward the outside of the body after implantation.

In FIGS. 1-3, implant 100 is understood to be comprised of an anterior side 110 and a posterior side 112. In FIGS. The implant 100 may also include a first lateral side 114 and a second lateral side 116 extending between a posterior side 112 and an anterior side 110 on opposite sides of the implant 100. Additionally, implant 100 may also include an upper side 130 and a lower side 140.

References to direction or axis refer to the implant itself, not to its intended orientation relative to the body. For example, the term "distal" refers to a portion located farther from the center of the implant, whereas the term "proximal" refers to a portion located closer to the center of the implant. As used herein, the "center of the implant" could be the center of mass, and/or the central plane, and/or another reference plane centrally located.

Implants may also be associated with various axes. Referring to FIG. 1, implant 100 may be associated with a transverse axis 120 extending along implant 100 between first lateral side 114 and second lateral side 116. Referring to FIG. Additionally, the implant 100 may be associated with an anteroposterior axis 122 extending between the posterior side 112 and the anterior side 110. The implant 100 may also be associated with a vertical axis 124 that extends along the thickness dimension of the implant 100 and is generally perpendicular to both the transverse axis 120 and the anterior-posterior axis 122.

The implant may also be associated with various reference planes or surfaces. As used herein, the term "median plane" refers to the vertical plane passing from the anterior side to the posterior side of the implant that divides the implant into right and left halves, or into two lateral halves. refers to As used herein, the term "cross section" refers to a horizontal plane located at the center of the implant that divides the implant into an upper and a lower half. As used herein, the term "coronal plane" refers to the vertical plane located at the center of the implant that divides the implant into anterior and posterior halves. In some embodiments, the implant is symmetrical about two planes, such as a cross section.

<Surrounding structure>
In some embodiments, the body portion may include a peripheral structure and one or more support beams extending from the peripheral structure. The surrounding structure may consist of any number of plates, walls or similar structures. In some embodiments, the peripheral structure could include a ring. In other words, in some embodiments the peripheral structure could be a peripheral ring structure.

As seen in FIGS. 1-3, the body portion 102 may further include a peripheral structure 150. As seen in FIGS. Peripheral structure 150 is shown to have a ring-like geometry.

4 is a schematic isometric view of the body portion 102 shown alone without any arcuate contacting elements, and FIG. 5 is a schematic isometric view of the body portion 102 separated from any arcuate contacting elements. FIG.

Referring to FIGS. 4-5, the peripheral structure 150 may further include a front side 152, a rear side 154, a first lateral side 156, and a second lateral side 158.

As seen in FIGS. 1-2, in this example, the peripheral structure 150 has a front side 152 connected to a first outer side 156 and a first outer side 156 connected to a rear side 154. , a continuous structure such that the rear side 154 is connected to the second outer side 158 and the second outer side 158 is connected to the front side 152. That is, the front side 152, the first lateral side 156, the rear side 154, and the second lateral side 158 together form a continuous or uninterrupted ring.

6 is a schematic front view of the implant 100, while FIG. 7 is a schematic rear view of the implant 100.

Referring to Figures 4-7, the front side 152 is further comprised of a first front portion 160 and a second front portion 162. The first outer side 156 extends from the first front portion 160 of the front side 152 to the rear side 154. Similarly, the second outer side 158 extends from the second front portion 162 of the front side 152 to the rear side 154.

The first anterior portion 160 is comprised of a distal surface 164 (best seen in FIG. 6), a superior surface 166, and a inferior surface 168. The first front portion 160 also includes a first outer surface 170 and a second outer surface (not shown) opposite the first outer surface 170. Additionally, first anterior portion 160 includes a proximal surface 174 joined to second support beam 254, as described below.

Second anterior portion 162 includes a distal surface 184 (best seen in FIG. 6), a superior surface 186, and a inferior surface (not shown). The second forward portion 162 also includes a first outer surface 190 (see FIG. 5). Further, the second anterior portion 162 includes a proximal surface 194 joined to the third support beam 256, as described below. Additionally, the second front portion 162 is located adjacent to the first front portion 160. In some embodiments, first anterior portion 160 and second anterior portion 162 are joined together.

Each of the first outer side 156 and the second outer side 158 includes a distal surface joined to a proximal surface. In some cases, the proximal surface may be convex. For example, the first outer side 156 includes a distal surface 210 and a proximal surface 212, where the proximal surface 212 is convex and is joined directly to the distal surface 210 along the upper and lower sides of the implant 100.

The posterior side 154 of the implant 100 includes an upper surface 200 and an inferior surface 202 (see FIG. 7). The posterior side 154 also includes a distal surface 204 and a proximal surface 206. As seen in FIG. 5, the geometry of the implant 100 at the posterior side 154 tapers toward the first lateral side 156 and the second lateral side 158.

In some embodiments, the vertical height or thickness of different portions of the surrounding structure could vary. In the embodiment shown in FIG. 6, which shows a schematic front view of the implant 100, the first anterior portion 160 is shown to have a first height 300, while the second anterior portion 162 has a second height. 302. Here, the first height 300 is shown to be greater than the second height 302. In some embodiments, this tapering in height from the centrally located first anterior portion 160 to the adjacent second anterior portion 162 imparts a convex shape to the anterior sides 152 of the peripheral structure 150, Helps provide a better fit between adjacent vertebral bodies during implantation.

Also, as seen in FIG. 7, the height of the surrounding structure 150 along the aft side 154 is shown as a third height 304. In some embodiments, the third height 304 is less than the first height 300. Further, in some cases, third height 304 may be slightly less than second height 302.

In some embodiments, the variation in height or vertical thickness between the posterior and anterior sides of the implant causes the implant to have a hyperlordotic angle between the inferior and superior sides. It may be possible to do so. In other embodiments, vertical thickness variation may be used to control the relative stiffness of the device at different locations.

In some embodiments, the thickness of the peripheral structure 150 is greater along both the first lateral side 156 and the second lateral side 158 than along either the anterior side 152 or the posterior side 154. It may be smaller along the lines of . In the example, the first outer side 156 and the second outer side 158 have a similar fourth height 306. Here, the fourth height 306 is smaller than the first height 300, the second height 302, and the third height 304. By using a reduced height or vertical thickness for the lateral side compared to the anterior and posterior sides, the lateral side is maintained while maintaining a smooth vertical profile across the superior and inferior sides of the implant 100. Arcuate contact elements can be attached to the sides (see Figure 7).

<Support beam>
In some embodiments, the body portion may include one or more support beams (or support structures) that act to reinforce surrounding structures. In some embodiments, one or more support beams could be placed along the interior of the surrounding structure. For example, in some embodiments, the one or more support beams move from a first location on an inwardly facing surface of the support structure to a second location on an inwardly (or proximally) facing surface of the support structure. It would be possible to extend to the position. In other words, in some embodiments, one or more support beams may span an interior region bounded by a surrounding structure.

As seen in Figures 4-5, the body portion 102 includes a plurality of support beams 250. These include a first support beam 252, a second support beam 254, and a third support beam 256.

In the embodiment shown in FIGS. 4-5, each of these support beams moves from a first position on the inwardly facing surface 260 of the surrounding structure 150 to a first position on the inwardly facing surface 260 of the surrounding structure 150. It extends to two positions. wherein the inwardly facing surface 260 of the surrounding structure 150 is comprised of proximal surfaces on various sides of the surrounding structure 150 (e.g., proximal surface 174, proximal surface 194, proximal surface 212, etc.). That will be understood.

4-5, the first support beam 252 has a first end 270 attached at a first forward position 271 of the inwardly facing surface 260 and a second forward end 270 of the inwardly facing surface 260. It includes a second end 272 attached at location 273. Similarly, second support beam 254 and third support beam 256 each include opposing ends attached at different locations along inwardly facing surface 260. It can be seen that this configuration allows the plurality of support beams 250 to span an interior region 290 (or central region) bounded by peripheral structure 150.

The plurality of support beams 250 may be considered to be centrally located within the implant 100 with respect to surrounding structures 150. As used herein, "central location" does not refer to a precise location that is the geometric center or center of mass of the implant, but rather within surrounding structures (e.g., within interior region 290). ) Refers to the general area or area in which the area is located. Therefore, in the following description and claims, the support beam may be referred to as the central beam.

In different embodiments, the number of support beams could vary. In some embodiments, a single support beam could be used. In other embodiments, two or more support beams could be used. In the example shown in Figures 4-5, three support beams are used.

In different embodiments, one or more of the beams could be oriented differently. In some embodiments, two or more of the support beams could be oriented parallel. In other embodiments, two or more of the support beams could be disposed at an oblique angle to one another. In an example, the first support beam 252, the second support beam 254, and the third support beam 256 may be disposed parallel to one another. Also, in an example, the plurality of support beams 250 may be oriented in a rear-forward direction (i.e., along the fore-aft axis 122). Of course, in other embodiments, the plurality of support beams 250 could be oriented in any other direction.

In different embodiments, the spacing or separation between adjacent support beams could be varied. In some embodiments, the spacing between adjacent support beams could be small compared to the lateral width of the implant. For example, the spacing could range from 0% to 10% of the width of the implant. In other embodiments, the spacing between adjacent support beams could be increased relative to the width of the implant. For example, the spacing could range from 10% to 95% of the width of the implant (e.g., two beams located adjacent to both lateral sides of the implant could be separated by 95% of the width of the implant). %). The spacing between adjacent beams (or between beams and portions of surrounding structures) may be constant or may vary across the implant.

The relative spacing between the support beams depends on a number of factors, including the thickness of the support beam or beams, the number of support beams used, the desired strength-to-weight ratio for the implant, and other factors. It will be understood that you may choose. Furthermore, since the arcuate contacting elements extend between adjacent support beams (or between a support beam and a surrounding structure), the spacing between adjacent support beams can be adjusted depending on the dimensions of the one or more arcuate contacting elements. may be determined.

In the embodiment shown in FIG. 4, the first support beam 252 is spaced apart from the first outer side 156 by a spacing 292. The first support beam 252 and the second support beam 254 are spaced apart from each other by a spacing 294. The second support beam 254 and the third support beam 256 are spaced apart from each other by a spacing 296. Third support beam 256 is spaced apart from second outer side 158 by a spacing 298. In the example, each of spacing 292, spacing 294, spacing 296, and spacing 298 has a value in the range of approximately 15% to 30% of width 199 of implant 100. Of course, it will be appreciated that the spacing between adjacent components can vary, such as along the anteroposterior axis 122, so that each spacing is an average or approximate spacing.

In different embodiments, the geometry of one or more support beams could be varied. In some embodiments, one or more support beams could have a curved geometry. In other embodiments, one or more of the support beams could have a substantially straight geometry.

In the embodiment shown in FIGS. 4-5, each of the plurality of support beams 250 has a substantially straight geometry. Additionally, the cross-sectional geometry of each support beam is substantially rounded. However, in other embodiments, the one or more support beams can have any other cross-sectional shape, including but not limited to rectangular, polygonal, regular and/or irregular shapes. Will. The cross-sectional shape could also vary over the length of the support beam, for example from a round cross-sectional shape (eg circular or oval) to a polygonal cross-sectional shape (eg rectangular).

In different embodiments, the thickness of one or more support beams could vary. Generally, the thickness (or diameter) of the support beam could vary from 1% to 95% of the width (or length) of the implant. In embodiments, the first support beam 252, the second support beam 254, and the third support beam 256 have diameters ranging from about 2% to 15% of the width 199 of the implant 100, as seen in FIG. More specifically, second support beam 254 has a diameter 255 that is greater than diameter 253 of first support beam 252 and greater than diameter 257 of third support beam 256 .

In some cases, second support beam 254 may have a maximum diameter. This larger diameter for the second support beam 254 is because the impact force is applied to the center of the implant 100 (where the second support beam 254 is located) by a device coupled to the implant 100 at the first interior portion 160. , may help reinforce the center of the implant 100.

In at least some embodiments, the support beams within the body of the implant may be coplanar.

4-5, it can be seen that the first support beam 252, the second support beam 254, and the third support beam 256 are in a similar plane of the implant 100. The coplanar arrangement of the support beams may help provide a generally symmetrical arrangement for the implant 100 between the upper and lower sides.

In general, the geometry of one or more portions of the body of the implant may vary depending on the embodiment. For example, a portion of the body can include one or more windows, slots, and/or openings that may promote bone growth through the implant and/or reduce weight.

<Fascinating means>
Some embodiments may include one or more fastener receiving means. Some embodiments may include one or more attachment apertures that engage an insertion or implantation device. In some embodiments, the implant can include one or more threaded cavities. In some embodiments, a threaded cavity can be configured to mate with a corresponding threaded tip on an implantation tool or device. In other embodiments, the threaded cavity can receive a fastener for fastening the implant to another device or component within an implantation system that uses multiple implants and/or multiple components.

As best seen in FIG. 6, implant 100 includes a first threaded cavity 360 located in first anterior portion 160. As best seen in FIG. Implant 100 also includes a second threaded cavity 362 located in second anterior portion 162. In some embodiments, first threading cavity 360 may receive a threading tip of an implantation tool (not shown). Such a tool could be used to thread the implant 100 between adjacent vertebral bodies.

Optionally, in some cases, implant 100 may also include a pair of indentations (indentation 365 and indentation 367) that facilitate alignment between the implantation tool and implant 100. In some embodiments, the second threaded cavity 362 could be used to fasten the implant 100 to a separate component (not shown) of a broader implantation system. For example, some embodiments could incorporate a separate plate that is fastened to the implant 100 using fasteners secured within the second threaded cavity 362. Such a plate could include additional fixation members (eg, screws) that could be used with the implant.

<Acuate bone contact element>
In some embodiments, the arcuate bone contacting element may include a first end, a middle portion, and a second end. In some embodiments, the intermediate section may have an arcuate geometry. In such cases, the intermediate section having an arcuate geometry is referred to as an "arcuate section." In some embodiments, the first end and/or the second end could have a flared geometry. In such cases, the end with the flared geometry is referred to as the "flared leg" of the arcuate bone contacting element.

FIG. 8 is a schematic diagram of an exemplary arcuate bone contacting element viewed in isolation, including several enlarged schematic cross-sectional views at various locations of the element.

Referring to FIG. 8, arcuate bone contacting element 400 includes a first end, referred to as a first flared leg 402. Referring to FIG. Arcuate bone contacting element 400 also includes an arcuate portion 404. Additionally, arcuate contacting element 400 also includes a second end, referred to as a second flared leg 406.

In some embodiments, the arcuate contacting element can include means for engaging the vertebral body after implantation. In some embodiments, the one or more arcuate contacting elements can include at least one distal surface region configured to directly contact a vertebral endplate. In some cases, the distal surface region could be a flat surface region. In other cases, the distal surface region could be a convex region. In still other cases, the distal surface region could be a concave region. More generally, the distal surface region could have a different curvature than the adjacent surface region of the arcuate portion. Also, the particular curvature for the distal face region could be selected to match the local geometry of the opposing vertebral endplates.

By way of example, in FIG. 8, arcuate bone contacting element 400 can be seen to include a distal surface region 490 disposed within arcuate portion 404. As shown in FIG. In some embodiments, distal surface region 490 may have a convex curvature that is less than the curvature of adjacent regions of arcuate portion 404. Similarly, as best seen in FIG. 7, the remaining arcuate bone contacting elements of implant 100 are also comprised of a distal bone contacting region that has a smaller curvature than the adjacent surface area of arcuate portion 404. (i.e., these distal surface regions may be flatter than the remaining regions of arcuate portion 404, but may not be completely flat). Together, these distal bone contact areas provide a partially smooth surface that can engage the vertebral body.

Furthermore, in some embodiments, the collection of flat (or convex) bone contact areas provides a minimum contact surface with the bone, thereby allowing a greater amount of graft material or bone growth promotion material to be placed in direct contact with the bone. In particular, bone growth promotion material that is placed between the arcuate bone contact elements, including those that are placed in the open areas along the upper and lower surfaces, may be placed in direct contact with the bone.

For reference purposes, arcuate contacting element 400 may be characterized as having a curved central axis 401. As used herein, the central axis of curvature of an element is an axis that extends along the length of the element and is located approximately at the center of the element at each location along its length.

It will be appreciated that the cross sections described below and shown in FIG. 8 are along a plane perpendicular to the central axis of curvature 401.

As seen in FIG. 8, arcuate portion 404 has an arcuate geometry. It can also be seen that the arcuate portion 404 has a rounded cross-sectional shape. More specifically, in some cases, arcuate portion 404 has a generally circular (or nearly circular) cross-sectional shape. In some embodiments, the diameter and cross-sectional shape of the arcuate portion 404 remains relatively constant along most of the length of the arcuate portion 404 (i.e., along the central axis of curvature 401). . However, it will be appreciated that the cross-sectional shape of the arcuate portion 404 can vary, for example along the flat bone contacting region 490. For reference, a cross-section of arcuate portion 404 at reference plane 471 is shown in FIG. Of course, in other embodiments, arcuate portion 404 can have any other cross-sectional shape.

At each flared leg, the cross-sectional shape of the arcuate bone contacting element 400 may vary. For example, as seen in FIG. 8, the cross-sectional shape of the first flared leg 402 has a first cross-sectional shape 410 at a location adjacent to the arcuate portion 404 (at the reference plane 472). The first flared leg 402 also has a second cross-sectional shape 412 and a third cross-sectional shape 414. Here, the third cross-sectional shape 414 is at the farthest position from the arcuate portion 404 (at the reference plane 474), and the second cross-sectional shape 412 is at the first flared leg (at the reference plane 473). It is at an intermediate position along section 402.

As shown in FIG. 8, the cross-sectional shape of the first flared leg 402 changes from a substantially circular cross-sectional shape (i.e., the first cross-sectional shape 410) to a substantially elliptical cross-sectional shape (i.e., the third cross-sectional shape 414). and changes. For example, the first cross-sectional shape 410 of the first flared leg 402 has a similar diameter 420 along both the first axis 430 and the second axis 432. However, the second cross-sectional shape 412 has a major diameter 422 along the first axis 430 that is larger than its minor diameter 424 along the second axis 432 . Further, the third cross-sectional shape 414 also has a large diameter 426 along the first axis 430 and a small diameter 428 along the second axis 432, with the large diameter 426 being larger than the larger diameter 422 and the smaller diameter 428 being smaller than the small diameter 424. It's also big. Therefore, the cross-sectional size of the first flared leg 402 also increases as its shape changes from a substantially circular shape to a substantially elliptical shape.

With the configuration described above, the cross-sectional area of the arcuate bone contacting element 400 may be smallest at the arcuate portion 404. Furthermore, when moving from the arcuate portion 404 to the first flared leg 402 along the central axis of curvature 401, the maximum is reached at the farthest end of the first flared leg 402 (similarly, the second flared leg 402 The cross-sectional area increases until it reaches a maximum at the farthest end of leg 406.

This increase in cross-sectional area may provide a wider base for each arcuate contacting element in its attachment to the body, thus increasing the attachment strength between the arcuate contacting element and the body portion. Also, the change in cross-sectional shape allows the increase in size to be directed primarily in a direction parallel to the substructure (e.g. the support beam or the cross-section of the surrounding structure).

For example, as seen in FIG. 9, the first flared leg 402 has a longest dimension that is parallel to the central axis 480 of the peripheral segment 482 to which the first flared leg 402 is attached. Here, peripheral segment 482 is a segment of implant 499. The first flared leg 402 also has a minimum dimension parallel to the widthwise axis 484 of the peripheral segment 482. Accordingly, the attachment surface area between the arcuate bone contacting element 400 and the peripheral segment 482 is increased while preventing the first flared leg 402 from extending beyond the peripheral segment 482 in the direction of the widthwise axis 484.

Although the geometry of the first flared leg 402 is described in detail, it is understood that the second flared leg 406 may have a similar geometry as the first flared leg 402. will be done. Similarly, the flared legs of the remaining arcuate bone contacting elements of the implant 100 may also have a similar geometry to the first flared leg 402.

The particular cross-sectional geometries shown (circular and oval) for the portion of the arcuate contact element in Figure 8 may be a schematic illustration of possible variations in the geometry for the arcuate contact element. only intended. In some embodiments, the flared legs may have a more irregular geometry while elongating with increasing size along one axis, substantially It does not have an elliptical cross-sectional shape. Also, the cross-sectional shape could be varied between any two shapes at either end of the flared leg. Cross-sectional shapes include, by way of example, rounded (including circular and oval), rectangular, polygonal, regular, irregular, and any other shape. including but not limited to.

Embodiments could include any number of arcuate contact elements. Some embodiments may include a single arcuate contact element. Still other embodiments may include any number of arcuate contacting elements ranging from 2 to 50. In yet other embodiments, the implant can include more than 50 elements.

In the embodiment shown in FIGS. 1-3, the implant 100 includes 18 arcuate contacting elements, including 9 elements on the upper side 130 and 9 elements on the lower side 140. including. The number of arcuate bone contacting elements used will vary depending on factors including implant size, desired implant strength, desired volume for bone graft or other bone growth promoting material, and potentially other factors. be able to.

In different embodiments, the placement of the arcuate bone contacting elements of the implant can be varied. In some embodiments, the arcuate contacting element can be attached to any portion of the surrounding structure, to any beam of the implant, and to other arcuate contacting elements. In some embodiments, the arcuate bone contacting element can extend across the entire width of the implant. In other embodiments, the arcuate bone contacting element may only extend across a portion of the width of the implant.

To increase the strength of the implant, some embodiments may use arcuate contact elements that only extend between adjacent beams or between a beam and an adjacent portion of the surrounding structure.

FIG. 10 is a schematic top view of the implant 100. Referring to FIG. 10, the plurality of arcuate contacting elements 104 includes an upper set of arcuate contacting elements 502 and a lower set of arcuate contacting elements 504 (visible in FIG. 7). The upper set 502 further includes a first group 510 (or simply the first group 510) of arcuate contacting elements, a second group 512 (or simply the second group 512) of arcuate contacting elements, and a second group 512 (or simply the second group 512) of arcuate contacting elements. A third group 514 (or simply the third group 514) and a fourth group 516 (or simply the fourth group 516) of arcuate bone contacting elements.

In the embodiment of FIG. 10, each group of arcuate bone contact elements includes two or more elements extending between the same two beams or between the same beam and the same side of the peripheral structure 150.

As seen in FIG. 10, the first group 510 includes a first arcuate contacting element 521, a second arcuate contacting element 522, and a third arcuate contacting element 523. Each of these elements extends between a first outer side 156 of peripheral structure 150 and a first support beam 252 . For example, the first arcuate bone contacting element 521 has a flared leg 531 attached to the first lateral side 156 and a flared leg 532 attached to the first support beam 252. Similarly, each of the second arcuate contacting element 522 and the third arcuate contacting element 523 is attached to the first support beam 252 with one flared leg attached to the first lateral side 156. It has separate flared legs.

The second group 512 includes a fourth arcuate contacting element 524 and a fifth arcuate contacting element 525. Each of these elements extends between a first support beam 252 and a second support beam 254. For example, the fourth arcuate contacting element 524 has a flared leg 541 attached to the first support beam 252 and another flared leg 542 attached to the second support beam 254. Similarly, the fifth arcuate contacting element 525 has a flared leg attached to the first support beam 252 and another flared leg attached to the second support beam 254.

The third group 514 includes a sixth arcuate contact element 526 and a seventh arcuate contact element 527. Each of these elements extends between a second support beam 254 and a third support beam 256. For example, the sixth arcuate contacting element 526 has a flared leg 551 attached to the second support beam 254 and another flared leg 552 attached to the third support beam 256. Similarly, seventh arcuate contact element 527 has a flared leg attached to second support beam 254 and another flared leg attached to third support beam 256 .

The fourth group 516 includes an eighth arcuate contacting element 528 and a ninth arcuate contacting element 529. Each of these elements extends between the third support beam 256 and the second outer side 158 of the surrounding structure 150. For example, the eighth arcuate contacting element 528 has a flared leg 561 attached to the third support beam 256 and another flared leg 562 attached to the second lateral side 158. . Similarly, the ninth arcuate contacting element 529 has a flared leg attached to the third support beam 256 and another flared leg attached to the second lateral side 158.

In some cases, some portions of adjacent arcuate contacting elements could be in contact or could partially overlap. For example, some embodiments could have flared legs that are touching or partially overlapping.

For example, in FIG. 10, flared leg 532 is positioned adjacent to and partially in contact with flared leg 541. However, it will be appreciated that each arcuate bone contacting element is attached to a portion of the body of the implant 100 at its end.

The ends of two or more arcuate bone contacting elements may contact each other, but the arcuate portion of each element remains separated from adjacent elements. In other words, there are no points of intersection between the arcuate portions of different arcuate bone contacting elements. Specifically, in some embodiments, the arcuate portions of each arcuate bone contacting element may not intersect or may be separated from each other. Also, there is no intersection of the arcuate contacting elements at or near the region where the arcuate contacting elements contact the vertebrae. It will thus be seen that the implant 100 provides a plurality of arcuate bone contacting elements 104 that are non-intersecting and are positioned to contact opposing vertebral surfaces.

Some embodiments may include means for allowing the structure to be self-supporting during manufacture, for example, if the structure is manufactured using a 3D printing process. In some embodiments, the placement of the arcuate contacting elements may be selected to facilitate self-support during manufacturing (eg, during a 3D printing process). In some embodiments, the arcuate bone contacting element can be positioned in an oblique orientation relative to the body or an axis of the body. In some embodiments, the arcuate contacting elements may be arranged in a herringbone pattern that is further comprised of individual V-shaped configurations of elements. Such a configuration would allow the implant to be printed with a self-supporting structure.

One or more arcuate bone contacting elements may be angled relative to one or more axes of the implant.

10, for example, the second arcuate bone contacting element 522 is oriented at an oblique angle relative to the lateral axis 120 (and also relative to the anterior-posterior axis 122). The fourth arcuate bone contacting element 524 is oriented at an oblique angle relative to the lateral axis 120 (and also relative to the anterior-posterior axis 122). The second bone contacting element 522 and the fourth bone contacting element 524 are oriented at different angles from the lateral axis 122.

As shown in FIG. 10, the remaining arcuate bone contact elements may also be oriented at an oblique angle relative to the transverse axis 120 of the implant 100. Thus, it will be seen that the arcuate bone contact elements are not arranged in parallel on the implant 100.

In some embodiments, at least two arcuate bone contacting elements may be arranged in a V-shaped configuration or pattern on the body of the implant. For example, second arcuate contacting element 522 and fourth arcuate contacting element 524 are arranged in a first V-shaped configuration 600. Furthermore, the sixth arcuate contacting element 526 and the eighth arcuate contacting element 528 are arranged in a second V-shaped configuration 602. Additionally, the third arcuate contacting element 523 and the fifth arcuate contacting element 525 are arranged in a third V-shaped configuration 604. Finally, the seventh arcuate contacting element 527 and the ninth arcuate contacting element 529 are arranged in a fourth V-shaped configuration 606. Although the present embodiment includes a four V-configuration on the upper side (i.e., the upper set of arcuate contact elements 502) and another four V-configuration on the lower side, other embodiments could include any other number of V-shaped configurations on the upper or lower sides.

In different embodiments, the positioning and orientation of the V-shaped configurations could be varied. In some embodiments, all of the V-shaped configurations may be oriented in a similar direction. In other embodiments, two or more V-shaped configurations could be oriented in different directions. Also, in some cases, two or more V-shaped configurations could be arranged in rows and/or columns.

In the embodiment shown in FIG. 10, each V-configuration has a common direction that corresponds to the anteroposterior axis 122. Specifically, each structure is arranged so that the tip of the V-shape points in a direction toward the rear side portion 154 along the front-back axis 122. Also, the first V-configuration 600 and the second V-configuration 602 are arranged adjacent to each other in the first row such that they have different positions along the horizontal axis 120. Similarly, third V-configuration 604 and fourth V-configuration 606 are positioned adjacent to each other in the second row. Additionally, the first V-configuration 600 and the third V-configuration 604 are positioned adjacent to each other in the first row such that they have different positions along the anterior-posterior axis 122. Similarly, the second V-configuration 602 and the fourth V-configuration 606 are positioned adjacent to each other in the second row.

As seen in FIG. 10, when considered together, the four V-shaped configurations form a large herringbone pattern 620 in the body portion 102.

Each V-configuration may be centered on a single support beam. For example, the first V-configuration 600 and the second V-configuration may be centered on the first support beam 252. Further, the third V-shaped configuration and the fourth V-shaped configuration may be centered on the third support beam 256.

Each V-shaped configuration may extend from the outer side of the body portion 102 to a central support beam (eg, second support beam 254). For example, first V-configuration 600 extends from first outer side 156 to second support beam 254 . A second V-shaped configuration 602 also extends from the second support beam 254 to the second outer side 158 .

In some cases, orienting the arcuate bone contacting element in a herringbone pattern may facilitate easier insertion of the implant. Specifically, by tilting the arcuate contact element away from the lateral direction, the element may present a smaller surface area along the implantation direction (i.e., posterior direction), which could potentially It will make your work easier.

The placement of the arcuate contacting elements may also be designed to achieve a desired total open volume. As used herein, total volume is the combined volume of any opening between the arcuate contacting elements, any opening within the body, or the opening between the arcuate contacting element and the body. . This open configuration may promote bone growth in or by the implant. A portion or all of the open space is optionally filled with bone graft or bone growth promoting material before or after insertion of the implant to promote bone growth.

The total volume of open space (also simply referred to as open space volume) within any particular implant depends on the overall dimensions of the implant as well as the sizes and dimensions of the individual components within the implant, including the arcuate bone contacting element. are doing. The open space volume may range from about 20% to 80% of the implant's volume. In some embodiments, the implant 100 may have an open space volume that is between 25% and 80% of the total volume of the implant. In further embodiments, the implant 100 may have an open space volume that is between 50% and 70% of the total implant volume.

In some embodiments, the implant can be configured with one or more symmetries. In some cases, the implant may have mirror symmetry about one or more reference planes. In other cases, the implant may have translational symmetry about one or more reference planes. In still other cases, the implant could have both mirror and translational symmetry.

Referring to FIGS. 1 and 2, implant 100 includes at least one mirror symmetry. For reference purposes, implant 100 may be divided into an upper half and a lower half. Here, the "upper half" of the implant 100 includes a portion of the body portion 102 and a plurality of arcuate bone contacting elements 104 disposed above the cross section. Similarly, the "lower half" of the implant 100 includes a portion of the body portion 102 and a plurality of arcuate bone contacting elements 104 located below the cross-section.

It will be seen that with respect to a cross section (which in this embodiment generally coincides with body portion 102), the upper half of implant 100 is a mirror image of the lower half of implant 100. This includes not only the geometry of the body, but also the shape, size and orientation of each arcuate contacting element. It will be appreciated that this mirror symmetry may only be an approximation in some embodiments. The symmetrical configuration of the implant 100, such as mirror symmetry between the upper and lower halves of the implant 100, helps balance loads in the vertical direction or along the length of the spine. Good too.

<Additional embodiment>
In different embodiments, the dimensions of the implant may vary. Examples of dimensions that could be varied include length, width, and thickness. Also, in some cases, the diameter of one or more arcuate contacting elements could vary depending on the embodiment.

Figure 11 is a schematic diagram of another embodiment of an implant 700. The implant 700 may be similar in many respects to the implant 100 shown in Figures 1-10 above. In some embodiments, the implant 700 may have a larger width and length (and thus a larger overall footprint) than the implant 100. To accommodate the larger size, the implant 700 may include an additional arcuate bone contacting element 702 on the upper side 710 and a corresponding element (not shown) on the lower side.

As seen in FIG. 11, the arcuate bone contacting element 702 extends from the support beam 720 to the lateral side 722 of the implant 700. This additional arcuate contacting element causes group 730 of arcuate contacting elements on lateral side 724 to have the same number of elements (i.e., three) as group 732 of arcuate contacting elements on lateral side 722. It turns out that it has. It can be seen that this configuration of the arcuate bone contacting element thus has mirror symmetry about the central axis 740 of the implant 700.

12-13 show schematic diagrams of another embodiment of an implant 800. Implant 800 may be similar in many respects to implant 100 and implant 700 shown in FIGS. 1-11 above. In some embodiments, implant 800 may have a greater width and length (and thus a larger overall footprint) than implant 700.

Some embodiments may include one or more arcuate contact elements attached at both ends to a single support beam. Some embodiments may include one or more arcuate contact elements attached to a single segment of the peripheral structure.

Referring to FIGS. 12-13, implant 800 is comprised of a plurality of arcuate bone contacting elements 804 attached to a body portion 802. Referring to FIGS. The body portion 802 further includes a peripheral structure 806, a first support beam 810, a second support beam 812, and a third support beam 814.

Referring now to FIG. 13, the plurality of arcuate contacting elements 804 include a first group of arcuate contacting elements 820 (or first group 820), a second group of arcuate contacting elements 822 (or group 822 ), a third group 824 (or third group 824 ) of arcuate contact elements, a fourth group 826 (or fourth group 826 ) of arcuate contact elements, and a fifth group 828 of arcuate contact elements. (or fifth group 828), a sixth group 830 (or sixth group 830) of arcuate contact elements, a seventh group 832 (or seventh group 832) of arcuate contact elements, and It further comprises an eighth group 834 (or eighth group 834).

A second group 822 includes arcuate contacting elements extending from the first lateral side 811 of the peripheral structure 806 to the first support beam 810 . A fourth group 826 includes arcuate contact elements extending from the first support beam 810 to the second support beam 812 . A fifth group 828 includes arcuate contact elements extending from the second support beam 812 to the third support beam 814 . A seventh group 832 includes arcuate bone contacting elements extending from the third support beam 814 to the second lateral side 813 of the peripheral structure 806 . Additionally, the arcuate bone contacting elements in the second group 822, fourth group 826, fifth group 828, and seventh group 832 are generally arranged in a herringbone pattern, similar to the arrangement of the arcuate bone contacting elements of the implant 100. They are arranged in an organized V-shaped configuration.

Because implant 800 has an increased footprint compared to implants 100 and 700, additional arcuate bone contact elements may be included to provide a larger (partial) contact surface on the upper and lower sides of implant 800.

In the embodiment shown in Figures 12-13, some of these additional arcuate bone contact elements are added along the outer side of the body portion 802 and along the first support beam 810, the second support beam 812, and the third support beam 814.

The first group 820 includes an arcuate bone contact element 901 and an arcuate bone contact element 902, both of which are connected at each end to a first outer side 811 of the peripheral structure 806. Specifically, for example, the arcuate bone contact element 901 includes a first flared leg 911 attached to the first outer side 811 and a second flared leg 912 attached to the first outer side 811.

Additionally, the third group 824 includes three arcuate contacting elements, each attached at both ends to the first support beam 810. For example, arcuate bone contacting element 903 includes a first flared leg 921 attached to first support beam 810 and a second flared leg 922 attached to first support beam 810 . Similarly, the sixth group 830 includes three arcuate contact elements. Each of these elements includes two flared legs, both attached to a third support beam 814. Furthermore, the eighth group 834 includes two arcuate bone contacting elements. Each of these elements includes two flared legs, each attached to a second outer side 813 of the peripheral structure 806.

<Surface texture processing>
Embodiments can include means for texturing one or more surfaces of the implant. Such texturing can increase or otherwise promote bone growth and/or fusion to the surface of the implant. In some embodiments, sections of the arcuate contacting element and/or body portion may be textured.

In some embodiments, the surface structure of one or more regions of the implant may be roughened or textured. Generally, this roughened structure may be achieved through the use of acid etching, bead or grit blasting, sputter coating with titanium, bead sintering of titanium or cobalt chromium, and other methods onto the implant surface. In some embodiments, roughness can be created by 3D printing a raised pattern on the surface of one or more regions of the implant. In some embodiments, the resulting roughened surface may have pores of varying sizes. In some embodiments, the pore size could range from about 0.2 mm to 0.8 mm. In one embodiment, the pore size could be about 0.5 mm. Of course, other embodiments are possible with surface roughness including pore sizes less than 0.2 mm and/or greater than 0.8 mm.

An embodiment using a textured surface is illustrated in the alternative embodiment and isometric view of implant 900 seen in FIG.

As can be seen in FIG. 14, the implant 900 includes a smooth peripheral surface 902. However, the remaining surfaces of the implant 900 are roughened. These include the visible portion of the upper surface 904, which is further comprised of the upper surface of the peripheral structure 950 and the surfaces of the plurality of arcuate bone contacting elements 952.

For illustrative purposes, the roughened surface is shown schematically using stippling. These roughened or porous surfaces may help improve bone growth along the surface of the implant. As a particular example, the arcuate bone contacting element 960 extends throughout the element, including a distal surface region 964 that is intended to directly contact the adjacent vertebrae (also shown in the enlarged schematic view of FIG. 15). It can be seen that it has a roughened surface area 962 (as seen).

It will be appreciated that any of the embodiments shown in the figures can include one or more roughened surfaces. For example, in some embodiments, implant 100, implant 700, or implant 900 could include one or more roughened surfaces. Also, the roughened surface could be selectively applied to some parts of the implant and not to others.

<Bone growth promoting material>
In some embodiments, bone growth can be promoted by applying a bone growth promoting material within or around a portion of the implant. As used herein, a "bone growth promoting material" (or BGPM) is any material that aids in bone growth. The bone growth promoting material may include means of being lyophilized to the surface or attached to the metal through the use of linker molecules or binders.

Examples of bone growth promoting materials are any materials that include bone morphogenetic proteins (BMPs) such as BMP-1, BMP-2, BMP-4, BMP-6 and BMP-7. These are hormones that convert stem cells into bone-forming cells. Another example includes recombinant human BMPs (rhBMPs) such as rhBMP-2, rhBMP-4 and rhBMP-7. Still other examples include platelet derived growth factor (PDGF), fibroblast growth factor (FGF), collagen, BMP mimetic peptides, and RGD peptides. Generally, combinations of these chemicals may also be used. These chemicals can be applied using sponges, substrates or gels.

Some bone growth promoting materials may also be applied to implantable prostheses using plasma spray or electrochemical techniques. Examples of these materials include, but are not limited to, hydroxyapatite, beta tricalcium phosphate, calcium sulfate, calcium carbonate, and other chemicals.

Bone growth promoting materials may include or be used in combination with bone grafts or bone graft substitutes. Various materials serve as bone grafts or bone graft substitutes, including autograft (extracted from the iliac crest of the patient's body), allograft, demineralized bone matrix, and various synthetic materials. Good too.

Some embodiments may use autografts. The autografts provide a calcium-collagen scaffold for new bone growth (osteoconductive) for spinal fusion. Additionally, the autografts contain bone growth cells, mesenchymal stem cells, and osteoblasts to regenerate bone. Finally, the autografts contain bone growth proteins, including bone morphogenetic proteins (BMPs), to promote new bone growth in the patient.

Bone graft substitutes include calcium phosphate or hydroxyapatite, stem cell-containing products that combine stem cells with one of the other types of bone graft substitutes, and Medtronic, Inc. Synthetic materials containing growth factor-containing matrices such as INFUSE® (rhBMP-2-containing bone graft) may also be included.

It should be understood that the measures listed herein are not intended to be an exhaustive list of possible bone growth promoting materials, bone grafts or bone graft substitutes.

In some embodiments, the BGPM may be applied to one or more exterior surfaces of the implant. In other embodiments, the BGPM may be applied to an interior volume within the implant. In yet other embodiments, the BGPM may be applied to both the exterior surfaces and the interior of the implant.

<Manufacturing and materials>
The various components of the implant may be suitable for use in the human body, including, but not limited to, metals (e.g., titanium or other metals), ceramics, and/or combinations thereof, depending on the particular application and/or physician selection. It may be manufactured from biocompatible materials suitable for implantation.

Generally, the implant can be formed from any suitable biocompatible, non-degradable material with sufficient strength. Typical materials include, but are not limited to, titanium, biocompatible titanium alloys (e.g., gamma titanium aluminide, Ti6-Al4-V ELI (ASTM F 136) or Ti6-Al4-V (ASTM F 1108 and ASTM
F 1472)) and inert biocompatible polymers such as polyetheretherketone (PEEK) (eg, PEEK-OPTIMA®, Invibio Inc). Optionally, the implant includes radiopaque markers to facilitate visualization during imaging.

In different embodiments, the process of making the implant can vary. In some embodiments, the entire implant is injection molded, cast or injection molded, insert molded, coextruded, pultruded, transfer molded, overmolded, compression molded, three-dimensional (3D) printed, dip coated, spray coated. may be manufactured and assembled by powder coating, porous coating, milling from solid raw materials, and combinations thereof. Additionally, embodiments may utilize any of the features, components, assemblies, processes and/or methods disclosed in the Coiled Implant Application.

The design of the embodiments (e.g., implant 100, implant 700, and implant 900) may help provide improved and/or accelerated bone fusion. Specifically, after implantation of one of the implants, bone fusion may occur first at one or more distal surfaces, or apexes, of the arcuate bone contacting elements. From these distal surfaces, bone growth may continue down along the arcuate portion of each arcuate bone contacting element and thus may be directed to grow toward the interior of the implant. In this manner, new bone growth initiated at the distal surfaces of the upper and lower sides of the implant may be directed toward the center of the implant and may eventually merge to form a continuous section of new bone growth extending from one vertebral body, through the implant, to an adjacent vertebral body. Furthermore, this may result in an accelerated fusion process between the vertebral bodies over structures where the bone contacting elements are primarily located on the surface of the implant and do not extend medially.

<Implant for anterolateral interbody fusion>
16-24 show various schematic illustrations of alternative embodiments of implants and methods of use. In some embodiments, the implant may be inserted using an oblique lateral interbody fusion (OLIF) surgical procedure, in which the disc space is inserted into the spine from the side. It is healed by approaching it.

FIG. 16 shows a schematic illustration of a patient 1000 lying on his side, with the implant in position for insertion into the body. In the OLIF approach, an incision 1002 (which may be 3 to 5 inches long) may be made in the side of the abdomen.

Figure 17 shows a schematic diagram of a region of the spine 1010, including multiple vertebrae 1012. To understand the OLIF surgical procedure, several variations of spinal procedures are shown. These procedures are shown in Figure 17 as a schematic diagram of the approach to the spine.

These include an anterior lumbar interbody fusion (ALIF) approach 1020, a direct lateral interbody fusion (DLIF) approach 1022, and an OLIF approach 1024. In the ALIF approach 1020, a surgical incision is made in the front of the abdomen and an implant is inserted along the anteroposterior direction relative to the spine. In the DLIF approach 1022, a surgical incision is made on the side of the abdomen and the implant is inserted laterally to the spine. OLIF approach 1024 may be similar to DLIF approach 1022 in some respects. However, in contrast to the DLIF approach 1022, the OLIF approach 1024 inserts the implant from an oblique angle, providing direct access to the lowest lumbar vertebrae that may be obscured by pelvic bone in a direct lateral approach. enable.

18-19 show isometric and side views, respectively, of an embodiment of an OLIF implant 1100, also referred to simply as implant 1100. Implant 1100 may also be referred to as a cage or fixation device. In some embodiments, implant 1100 is configured to be implanted within a portion of the human body. In some embodiments, implant 1100 may be configured for implantation into the spine. In some embodiments, implant 1100 may be a spinal fixation implant or device that is inserted between adjacent vertebrae to provide support between the vertebrae and/or to facilitate fusion between the vertebrae.

In some embodiments, implant 1100 may include a body portion 1102. Body portion 1102 may generally provide a frame or scaffold for implant 1100. In some embodiments, the implant 1100 may also include multiple arcuate contact elements 1104. The plurality of bone contacting elements 1104 may be attached to and/or continuously formed (or “integrally formed”) with the body portion 1102.

In FIGS. 18-19, the implant 1100 is understood to be comprised of an anterior side and a posterior side. Implant 1100 may also include a first lateral side and a second lateral side extending between a posterior side and an anterior side on opposite sides of implant 1100. Additionally, the implant 1100 may also include an upper side 1130 and a lower side 1140 (see FIG. 19).

For clarity, discussion will primarily center on the upper side 1130 of the implant 1100. However, it will be appreciated that in some cases the implant 1100 is symmetrical with respect to a cross-section that divides the implant 1100 into an upper side 1130 and a lower side 1140. In such cases, the lower side 1140 may include the same means as described for the upper side 1130.

In some embodiments, the body may include a perimeter structure and one or more support beams extending from the perimeter structure. The perimeter structure may be comprised of any number of plates, walls, or similar structures. In some embodiments, the perimeter structure could include a ring. In other words, in some embodiments, the perimeter structure could be a perimeter ring structure.

As seen in FIGS. 18-19, the body portion 1102 may further include a peripheral structure 1150. Peripheral structure 1150 is shown to have a ring-like geometry.

Referring to FIG. 18, the peripheral structure 1150 may further include a front side 1152, a rear side 1154, a first lateral side 1156, and a second lateral side 1158.

As seen in FIG. 18, in this example, the peripheral structure 1150 is connected at a forward side 1152 to a first outer side 1156. Also, a first outer side 1156 is connected to the rear side 1154. Also, a rear side 1154 is connected to a second outer side 1158. The second outer side 1158 is a continuous structure connected to the front side 1152. That is, the front side 1152, the first lateral side 1156, the rear side 1154, and the second lateral side 1158 together form a continuous or uninterrupted ring.

The peripheral structure 1150 may be characterized by four corners. These include a first corner 1160, a third corner 1162, a second corner 1164, and a fourth corner 1166. The first corner 1160 may be located at the intersection of the front side 1152 and the first outer side 1156. The third corner 1162 may be located at the intersection of the front side 1152 and the second outer side 1158. The second corner 1164 may be located at the intersection of the rear side 1154 and the second outer side 1158. And the fourth corner 1166 may be located at the intersection of the rear side 1154 and the first outer side 1156.

In the embodiment of FIG. 18, the first corner portion 1160 and the second corner portion 1164 have an increased thickness relative to the third corner portion 1162 and the fourth corner portion 1166. Additionally, fasteners and/or insertion tool receiving means may be disposed on the first corner portion 1160, as described in more detail below. These means may aid in easy insertion of the implant 1100 along the bevel.

In some embodiments, the body portion may include one or more support beams (or support structures) that act to reinforce surrounding structures. In some embodiments, one or more support beams could be placed along the interior of the surrounding structure. For example, in some embodiments, the one or more support beams move from a first location on an inwardly facing surface of the support structure to a second location on an inwardly (or proximally) facing surface of the support structure. It would be possible to extend to the position. In other words, in some embodiments, one or more support beams may span an interior region bounded by a surrounding structure.

As seen in FIG. 18, body portion 1102 includes a plurality of support beams 1250. These include a first support beam 1252, a second support beam 1254 and a third support beam 1256.

In the embodiment shown in FIG. 18, each of these support beams moves from a first position on the surface of the inwardly facing peripheral structure 1150 to a second position on the surface of the inwardly facing peripheral structure 1150. It is extending.

Referring to FIG. 18, the first support beam 1252 includes a first end 1270 attached to a first location of the surrounding structure 1150 and a second end 1272 attached to a second location of the surrounding structure 1150. . Similarly, second support beam 1254 and third support beam 1256 each include opposing ends attached at different locations along peripheral structure 1150. It can be seen that this configuration allows the plurality of support beams 1250 to span an interior region (or central region) of the implant 1100 bounded by the peripheral structure 1150.

The support beams 1250 may be considered to be centrally located within the implant 1100 relative to the surrounding structures 1150. As used herein, "central location" does not refer to an exact location that is the geometric center or center of mass of the implant, but rather to a general area or region located inside the surrounding structures (e.g., within an interior region). Thus, in the following description and claims, the support beams may be referred to as central beams.

In different embodiments the number of support beams could vary. In some embodiments, a single support beam could be used. In other embodiments, more than one support beam could be used.

In the embodiment shown in Figure 18, three support beams are used.

In different embodiments, the geometry of one or more support beams could be varied. In some embodiments, one or more support beams could have a curved geometry. In other embodiments, one or more of the support beams could have a substantially straight geometry. In the embodiment shown in FIG. 18, each of the plurality of support beams 1250 has a substantially straight geometry. Additionally, the cross-sectional geometry of each support beam is substantially rounded. However, in other embodiments, the one or more support beams can have any other cross-sectional shape, including but not limited to rectangular, polygonal, regular and/or irregular shapes. Will.

In different embodiments, the thickness of one or more support beams could vary. Generally, the thickness (or diameter) of the support beam could vary from 1% to 95% of the width (or length) of the implant.

In at least some embodiments, the support beams within the body of the implant may be coplanar. In FIG. 18, it can be seen that first support beam 1252, second support beam 1254, and third support beam 1256 are in a similar plane of implant 1100. The coplanar arrangement of the support beams may help provide a generally symmetrical arrangement for the implant 1100 between the upper and lower sides.

In general, the geometry of one or more portions of the body of the implant may vary depending on the embodiment. For example, a portion of the body can include one or more windows, slots, and/or openings that may promote bone growth through the implant and/or reduce weight.

Some embodiments may include one or more fastener receiving means. In some embodiments, the implant can include one or more threaded cavities. In some embodiments, a threaded cavity can be configured to mate with a corresponding threaded tip on an implantation tool or device. In other embodiments, the threaded cavity can receive a fastener for fastening the implant to another device or component within an implantation system that uses multiple implants and/or multiple components.

As best seen in FIG. 20, the implant 1100 includes a receiving portion 1352 located at the first corner portion 1160. Receiving portion 1352 further includes a threaded cavity 1350. In some embodiments, threading cavity 1350 may receive a threading tip of an implantation tool (not shown). Such a tool could be used to screw the implant 1100 between adjacent vertebral bodies. Optionally, in some cases, implant 1100 may also include a pair of indentations (indentation 1365 and indentation 1367) that may facilitate alignment between the implantation tool and implant 1100. In some embodiments, threaded cavity 1350 could be used to fasten implant 1100 to a separate component (not shown) of a broader implantation system.

In some embodiments, the bone contacting element may include a first end, an intermediate portion, and a second end. In some embodiments, the intermediate section may have a curved geometry. In some embodiments, the first end and/or the second end could have a flared geometry. In such cases, the ends with flared geometry may be referred to as "flared legs" of the bone contacting element.

In different embodiments, the geometry of the bone contacting elements could be varied. In some embodiments, the bone contacting element could have a spiral or helical geometry. In other embodiments, the bone contacting elements could have other curved geometries. An example of the geometry of a bone contacting element is illustrated in FIG.

As seen in FIG. 21, the implant 1100 further includes a bone contacting element comprised of a first end 1491, a second end 1492, and an intermediate section 1490. The curvature of bone contacting element 1489 is represented by a curve 1494 extending along the length of bone contacting element 1489.

21, it can be seen that the curve 1494 is not straight or flat, but rather curved from the first end 1491 to the second end 1492. In some cases, the curve 1494 may be somewhat helical. Similarly, in some embodiments, the remaining bone contacting elements may have a similarly curved geometry.

As seen in FIGS. 18-19, the implant 1100 includes a plurality of bone contacting elements 110.
Contains 4. Each bone contacting element may include any of the features described above for bone contacting elements shown in FIGS. 8-10. In some embodiments, bone contacting elements 1104 may be grouped into various rows or sets.

As seen in FIG. 18, these may include a first set 1302, a second set 1304, a third set 1306, and a fourth set 1308. In this case, the first set 1302 includes two elements extending from the peripheral structure 1150 to the first support beam 1252. Similarly, the second set 1304 includes three elements extending from the first support beam 1252 to the second support beam 1254. Further, the third set 1306 includes three elements extending from the second support beam 1254 to the third support beam 1256. Finally, the fourth set 1308 includes two elements extending from the third support beam 1256 to the surrounding structure 1150.

In some embodiments, the bone contacting elements within each group may share some characteristics. For example, in the example of FIG. 18, the bone contacting elements in each group may have a similar orientation. In some cases, the bone contacting elements in each group may have a generally similar size (e.g., height and/or length), particularly relative to the size of the elements in other groups. In other embodiments, the arcuate bone contacting elements within a group could have different orientations and/or sizes.

In some embodiments, the bone contacting element can include means for engaging the vertebral body after implantation. In some embodiments, one or more bone contacting elements can include at least one bone contacting region. As mentioned above, the bone-contacting region may be an area of the surface of the bone-contacting member that has a different curvature compared to the surrounding area. Specifically, the surfaces within the bone contacting region could be convex, concave and/or generally flat to provide a better fit with the vertebral endplates during implantation.

In FIGS. 18-19, the plurality of bone contacting elements 1104 are shown to include a bone contacting region 1340. Together, these bone contacting areas provide a partially smooth surface that can engage the vertebral body.

Embodiments could include any number of bone contacting elements. Some embodiments may include a single bone contacting element. Still other embodiments could include any number of bone contacting elements ranging from 2 to 50. In yet other embodiments, the implant could include more than 50 elements.

In the example shown in FIG. 18, the implant 1100 includes 20 bone contacting elements, including 10 elements on the upper side 1130 and 10 elements on the lower side 1140. Specifically, first set 1302 includes two elements, second set 1304 includes three elements, third set 1306 includes three elements, and fourth set 1308 includes two elements. including. The number of bone contacting elements used can vary depending on factors including implant size, desired implant strength, desired volume for bone graft or other bone growth promoting material, and potentially other factors. can.

In different embodiments, the placement of the bone contacting elements of the implant could be varied. In some embodiments, bone contacting elements could be attached to any part of the surrounding structure, to any beam of the implant, and to other bone contacting elements. In some embodiments, the bone contacting element could extend across the entire width of the implant. In other embodiments, the bone contacting element may only extend across a portion of the width of the implant.

In some embodiments, the paired bone contacting elements can be arranged in a V-shaped configuration that collectively forms a herringbone pattern, such as one of the patterns described above and illustrated in FIGS. 10-13. Dew. Alternatively, in other embodiments, the bone contacting elements could be arranged in any other pattern or configuration.

Embodiments can include means to facilitate oblique lateral insertion of the implant. In some embodiments, one or more features of the implant may be aligned with the insertion axis.

FIG. 21 is a schematic diagram of an embodiment of an implant 1100. Referring to FIG. 21, the implant 1100 may be characterized by multiple axes. Implant 1100 may be associated with an anteroposterior axis 1400 extending from an anterior side 1152 to a posterior side 1154. Further, the implant 1100 may be associated with a transverse axis 1402 extending from a first lateral side 1156 to a second lateral side 1158.

The implant 1100 may further be associated with an additional axis that is oriented obliquely to the anteroposterior axis 1400 and the transverse axis 1402.

As seen in FIG. 21, implant 1100 may include a first diagonal axis, also referred to as insertion axis 1404. Insertion shaft 1404 may extend between first corner portion 1160 and second corner portion 1164. In some cases, insertion axis 1404 may run parallel to one or more of support beams 1250. Implant 1100 may also include a second diagonal axis 1406, which extends from third corner portion 1162 to fourth corner portion 1166.

As seen in FIG. 21, receiving portion 1352 may be associated with insertion shaft 1404. More specifically, threaded cavity 1350 may have a central axis 1351 (see FIG. 20) that is parallel to insertion axis 1404. This configuration ensures that the implant 1100 can be inserted at an oblique angle to the spine while ensuring that the implant 1100 is accurately oriented in the anteroposterior and lateral directions after insertion.

In different embodiments, one or more of the beams could be redirected. In some embodiments, two or more support beams could be oriented in parallel. In other embodiments, two or more support beams could be arranged at oblique angles to each other. In embodiments, first support beam 1252, second support beam 1254, and third support beam 1256 may be arranged parallel to each other. Additionally, in embodiments, a plurality of support beams 1250 may be oriented along insertion axis 1404. Of course, in other embodiments, the plurality of support beams 1250 could be oriented in any other direction.

In different embodiments, the spacing or separation between adjacent support beams could be varied. In some embodiments, the spacing between adjacent support beams could be small compared to the lateral width of the implant. For example, the spacing could range from 0% to 10% of the width of the implant. In other embodiments, the spacing between adjacent support beams could be increased relative to the width of the implant. For example, the spacing could range from 10% to 95% of the width of the implant (e.g., two beams located adjacent to both lateral sides of the implant could be separated by 95% of the width of the implant). %). The spacing between adjacent beams (or between beams and portions of surrounding structures) may be constant or may vary across the implant.

It will be appreciated that the relative spacing between the support beams may be selected depending on many factors, including the thickness of one or more support beams, the number of support beams used, the desired strength-to-weight ratio for the implant, and other factors. Additionally, because the bone contacting elements extend between adjacent support beams (or between a support beam and a surrounding structure), the spacing between adjacent support beams may be determined depending on the dimensions of one or more bone contacting elements.

In the embodiment illustrated in FIG. 21, each of support beam 1252, support beam 1254, and support beam 1256 is oriented parallel to insertion axis 1404. This will help improve the strength of the implant 1100 along the insertion direction. This is because this is the direction in which the load is applied during the OLIF surgical procedure.

In some embodiments, the geometry of the bone contacting element may be configured to align with one or more axes.

For example, in the embodiment illustrated in FIG. 21, the ends of bone contacting elements 1489 may be oriented generally along the support beam (or other structure) to which they are attached. Specifically, first end 1491 is oriented generally along support beam 1252 and second end 1492 is oriented generally along support beam 1254 (i.e., first and second is aligned with the insertion axis 1404). In contrast, the intermediate section 1490 may be oriented generally along a direction parallel to the anterior-posterior axis 1400. Additionally, some bone contacting elements have intermediate portions that are aligned along the anteroposterior axis 1400, whereas other bone contacting elements are aligned in a direction parallel to the second diagonal axis 1406. It has a middle part. In this configuration, the bone contacting element may provide strength along multiple directions of the implant, including directions associated with insertion axis 1404, anteroposterior axis 1400, and second diagonal axis 1406.

Embodiments may include means for ensuring a good fit with the endplates of adjacent vertebral bodies. As best seen in FIG. 22, which depicts a curved surface 1500 that generally conforms to the superior surface of the implant 1100, the bone contacting element 1104 may be configured to present generally convex superior and inferior surfaces that are curved along both the insertion axis 1404 and the second diagonal axis 1406.

As seen in FIG. 22, the curved surface 1500 is generally curved from the third corner portion 1162 down to the fourth corner portion 1166. In some cases, the curved surface 1500 may also be slightly curved from the first corner portion 1160 to the second corner portion 1164.

This generally convex surface may be configured to match a corresponding concave geometry of an adjacent vertebral endplate. Similarly, in some cases, the superior side of the implant 1100 may be provided with a snug convex surface that matches the corresponding concave geometry of the adjacent vertebral endplate.

This curvature is a convex curve along the upper side 1130, as seen in FIG. 1510 and another convex curve 1512 along the lower side 1140.

In some embodiments, this convex geometry is achieved by varying the length (and thereby varying the height) of the bone contacting element between the third corner portion 1162 and the fourth corner portion 1166. may be achieved by)

The height of an element may be proportional to its length, as seen in FIG. 24, which illustrates a schematic diagram of four adjacent bone contacting elements. For example, first bone contacting element 1520 has a first height 1530 and a first overall length 1531. Second bone contacting element 1522 includes a second height 1532 and a second overall length 1533. Third bone contacting element 1524 has a third height 1534 and a third overall length 1535. Fourth bone contacting element 1526 has a fourth height 1536 and a fourth overall length 1537. It may also be seen that the height generally increases from the first height 1530 to the third height 1534 and decreases slightly again to the fourth height 1536. Similarly, the overall length of each element changes correspondingly, increasing from the first overall length 1531 to the third overall length 1533 and decreasing slightly again until the fourth overall length 1537.

It will be appreciated that the implant 1100 may be configured with any of the means described and illustrated above in the embodiments of FIGS. 1-13. Such measures may include the use of textured surfaces, material structures and bone growth promoting materials. Thus, in some embodiments, implant 1100 may be configured with a textured surface. In other embodiments, the implant 1100 may be filled with bone growth promoting material prior to insertion into the spine.

Although various embodiments have been described, this description is intended to be illustrative rather than restrictive, and many more embodiments and implementations that are within the scope of the embodiments will occur to those skilled in the art. It is obvious that. Although many possible combinations of features are illustrated in the accompanying drawings and discussed in the detailed description of the invention, many other combinations of the disclosed features are possible. Any feature of any embodiment may be used in combination with or in place of any other feature or element of any other embodiment, unless specifically limited. As such, it will be appreciated that any of the features illustrated and/or described in this disclosure may be implemented together in any suitable combination. Accordingly, embodiments are not to be limited except in light of the appended claims and their equivalents. Additionally, various modifications and changes may be made within the scope of the appended claims.

<Related applications>
This application is filed in US Provisional Application No. 62/301,546, filed on February 29, 2016, US Provisional Application No. 62/217,542, filed on September 11, 2015, and US Provisional Application No. 62/217,542, filed on April 29, 2015. Morris et al., entitled “Coiled Implants and Systems and Methods Thereof,” which claims priority to U.S. Provisional Application No. 62/154,599, filed in 2018. McShane III, entitled "Implant with Arched Bone Contacting Elements", 2017, claims priority to U.S. Patent Publication No. 2016/0324656, published March 20, 2017. This is a continuation-in-part of US Patent Publication No. 2017/0042697, published February 16th. Each of the above applications is incorporated herein by reference in its entirety.

Claims (20)

An implant comprising a body portion configured with a peripheral structure and a plurality of bone contacting elements attached to the body portion, the implant comprising:
the body portion includes an opening for receiving a portion of an insertion device;
The peripheral structure includes a first outer part, a second outer part, a front part, and a rear part,
The first outer portion and the front portion are connected at a first corner portion of the peripheral structure, and the second outer portion and the rear portion are connected at a second corner portion of the peripheral structure,
the opening has a central axis and is located at the first corner portion of the peripheral structure;
The body portion of the implant further includes at least two support beams, a first of the two support beams extending along the central axis of the aperture , and a second support beam extending along the central axis of the aperture. extending substantially parallel to the support beam;
The implant, wherein at least one of the plurality of bone contacting elements extends across a gap from a first portion of the implant body to a second portion of the implant body. The implant of claim 1, wherein a central axis of the aperture extends in a direction oriented between the first corner portion and the second corner portion. 2. The transverse axis of the implant extends from a first outer side to a second outer side of the surrounding structure, and the central axis of the aperture is oriented obliquely to the transverse axis. or the implant according to claim 2. The implant of claim 1, wherein a first portion of the body portion includes the first support beam . 5. The implant of claim 4 , wherein a second portion of the body portion includes the second support beam . a main body portion including a peripheral structure, a first support beam, and a second support beam;
a plurality of bone contacting elements attached to the body portion;
An implant comprising:
The peripheral structure further includes a first outer portion, a second outer portion, a front portion, and a rear portion;
The first outer portion and the front portion are connected at a first corner portion of the peripheral structure, and the second outer portion and the rear portion are connected at a second corner portion of the peripheral structure,
the first support beam has a first end attached to the first corner portion of the peripheral structure; and the first support beam is attached to the second corner portion of the peripheral structure. a second end having a second end;
at least one of the plurality of bone contacting elements bridges a gap between the second support beam and the surrounding structure;
The implant, wherein each of the support beams is connected to an end of at least one bone contacting element of the plurality of bone contacting elements. 7. The implant of claim 6, wherein the first support beam and the second support beam are arranged in parallel. 7. The implant of claim 6, wherein the bone contacting element bridging the gap between the second support beam and the surrounding structure is non-linear. An implant according to any one of claims 6 to 8, wherein the body portion includes an opening for receiving a portion of an insertion device. 10. The implant of claim 9, wherein the aperture is located at the first corner. 11. The implant of claim 10, wherein the aperture has a central axis, and the central axis of the aperture is aligned with the first support beam. 7. The implant of claim 6, wherein an anteroposterior axis of the implant extends from the posterior portion to the anterior portion of the surrounding structure, and the first support beam is oriented obliquely to the anteroposterior axis. . A main body consisting of a peripheral structure,
a plurality of bone contacting elements attached to the body portion;
An implant comprising:
The peripheral structure further includes a first outer portion, a second outer portion, a front portion, and a rear portion;
the first outer portion and the front portion are connected at a first corner portion of the peripheral structure; the second outer portion and the rear portion are connected at a second corner portion of the peripheral structure;
The second outer portion and the front portion are connected at a third corner portion of the peripheral structure, and the first outer portion and the rear portion are connected at a fourth corner portion of the peripheral structure,
an axis extending between the first corner portion and the second corner portion;
The body of the implant further includes at least one support beam extending essentially parallel to the axis;
The implant, wherein at least one of the bone contacting elements is non-linear and extends across a gap from a first portion of the body to a second portion of the body . 14. The implant of claim 13, wherein the implant includes an opening for receiving a portion of an insertion device. 15. The implant of claim 14, wherein the aperture is located at the first corner. 14. The implant of claim 13 , wherein said at least one non-linear bone contacting element extends from said at least one support beam (referred to as a first support beam) . 17. The implant of claim 16 , wherein the at least one non-linear bone contacting element extends from the first support beam to the surrounding structure . 17. The implant of claim 16 , further comprising at least one second support beam essentially parallel to the first support beam . 19. The implant of claim 18, wherein the at least one non-linear bone contacting element extends from the first support beam to the second support beam. 14. The implant of claim 13, wherein the at least one non-linear bone contacting element has an arcuate configuration.

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