Controlled stiffness orthopedic implants and methods of manufacture - Patents.com

Abstract

To provide orthopedic implants with an implant stiffness that can be adjusted based on patient requirements.SOLUTION: An orthopedic implant 100 includes: a first porous ingrowth material region 110; a second porous ingrowth material region 120 coupled to the first porous ingrowth material region; and an intermediate region 130 disposed between the first porous ingrowth material region and the second porous ingrowth material region. The intermediate region has a stiffness that differs from at least one of the first and second porous ingrowth material regions, and may act as a stiffness modulating core.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS REFERENCE TO RELATED APPLICATIONS This application is a non-provisional application based on U.S. Provisional Patent Application No. 62 / 775,498, filed December 5, 2018, entitled “ADJUSTED STIFFNESS ORTHOPAEDIC IMPLANTS AND METHOD OF MANUFACTURE,” which is incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to medical implants, and in particular to orthopedic implants. [Background technology]

[0003] Orthopedic implants are commonly used to replace and / or repair patient anatomical structures damaged by disease and / or injury. To be successful, the implant must have sufficient strength. Insufficient implant strength can result in the implant failing and requiring revision. Although known implants can be successful, implant failure rates and rates of adverse patient events remain higher than desirable.

[0004] There is a need in the art for an implant that can overcome some of the aforementioned problems of known implants. Summary of the Invention [Problem to be solved by the invention]

[0005] Exemplary embodiments disclosed herein provide an orthopedic implant with an implant stiffness that can be adjusted based on the patient's needs. [Means for solving the problem]

[0006] In some exemplary embodiments provided according to the present disclosure, an orthopedic implant has a first porous ingrowth material region, a second porous ingrowth material region coupled to the first porous ingrowth material region, and an intermediate region disposed between the first and second porous ingrowth material regions, the intermediate region having a different stiffness than at least one of the first porous ingrowth material region or the second porous ingrowth material region.

[0007] In some exemplary embodiments provided in accordance with the present disclosure, an orthopedic implant includes a porous ingrowth material body having at least one opening and at least one stiffness adjusting feature, and at least one reinforcing element disposed in the at least one stiffness adjusting feature and configured to reinforce the porous ingrowth material body in at least one direction.

[0008] In some exemplary embodiments disclosed herein, a method of manufacturing a plurality of orthopedic implants is provided that includes manufacturing a strip of material including a composite of a first porous ingrowth material and a second porous ingrowth material, forming a plurality of through openings in the strip, and cutting a plurality of implant blanks from the strip, each implant blank having at least one of the formed through openings.

[0009] One possible advantage that can be realized by the exemplary embodiments disclosed herein is that the stiffness of the orthopedic implant may be adjusted to suit the specific needs of the patient to reduce the risk of providing an overly stiff implant.

[0010] Another possible advantage that may be realized by the exemplary embodiments disclosed herein is that the orthopedic implants may be manufactured in an economical manner.

[0011] The above and other features and advantages of the present invention, as well as the manner in which they are achieved, will become more apparent and the invention will be better understood by reference to the following detailed description of the embodiments of the invention in conjunction with the accompanying drawings. [Brief description of the drawings]

[0012] [Figure 1] 1 is a side view of one exemplary embodiment of an orthopedic implant having an intermediate region provided in accordance with the present disclosure. [Diagram 2] FIG. 2 is an exploded view of the orthopedic implant of FIG. 1. [Diagram 3] 1 is a side view of one exemplary embodiment of an orthopedic implant having a tapered intermediate region provided in accordance with the present disclosure. [Figure 4] 1 is a side view of one exemplary embodiment of an orthopedic implant having an intermediate region with stiffness tuning features provided in accordance with the present disclosure. [Diagram 5] FIG. 5 is a top view of the orthopedic implant of FIG. 4. [Figure 6A] 1 is a perspective view of one exemplary embodiment of an orthopedic implant having a plurality of reinforcing elements provided in accordance with the present disclosure. [Figure 6B] FIG. 6B is a partial cutaway view of the orthopedic implant of FIG. 6A. [Figure 7] 1 is a perspective view of one exemplary embodiment of an orthopedic implant provided in accordance with the present disclosure having an intermediate region with a pair of stiffness adjustment features; [Figure 8] 1 is a perspective view of one exemplary embodiment of an orthopedic implant provided in accordance with the present disclosure, having a notch with reinforcement material as disclosed herein; FIG. [Figure 9] 1 is a perspective view of one exemplary embodiment of an orthopedic implant having an intermediate region and a plurality of reinforcing ribs provided in accordance with the present disclosure; FIG. [Figure 10]1 is a perspective view of one exemplary embodiment of an orthopedic implant provided in accordance with the present disclosure having a middle region partially wrapped with a wrapping porous ingrowth material and a plurality of reinforcing ribs; FIG. [Figure 11] 1 is a perspective view of one exemplary embodiment of an orthopedic implant provided in accordance with the present disclosure having an intermediate region and a plurality of reinforcing ribs having rib notches; [Figure 12] 1 is a perspective view of one exemplary embodiment of an orthopedic implant provided in accordance with the present disclosure having a middle region wrapped with a wrapping porous ingrowth material and a plurality of reinforcing ribs; [Figure 13] 1 is a perspective view of one exemplary embodiment of a strip of material that may be used to form a number of orthopedic implants provided in accordance with the present disclosure. [Figure 14] FIG. 14 is a front view of the strip of material of FIG. [Figure 15] FIG. 15 is a plan view of the strip of material of FIGS. 13 and 14 having a plurality of apertures formed therethrough, with parting lines shown. [Figure 16] 1 is a perspective view of another exemplary embodiment of a strip of material that may be used to form a plurality of orthopedic implants provided in accordance with the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] Corresponding reference characters indicate corresponding parts throughout the several views. The examples set forth herein illustrate embodiments of the invention, and such examples should not be construed as limiting the scope of the invention in any manner.

[0014] With particular reference to Figures 1 and 2, one exemplary embodiment of an orthopedic implant 100 is shown. The orthopedic implant 100 has the general shape of a spinal implant, such as a vertebral implant, for implantation within the spinal column of a human or non-human animal. As shown, the implant 100 has a first porous ingrowth material region 110, a second porous ingrowth material region 120, and a separate porous or non-porous intermediate region 130 disposed between the ingrowth material regions 110, 120. As used herein, the "intermediate region" may also be referred to as a "stiffness adjustment region" and / or a "stiffness adjustment region." The intermediate region 130 has an upper surface 132 connected to the lower surface 111 of the material region 110 and a lower surface 131 connected to the upper surface 122 of the material region 120. As shown, the upper surface 132 and the lower surface 131 of the intermediate region 130 are both substantially flat, i.e., planar, such that the orthopedic implant 100 is a "flat" spinal implant. The lower surface 111 of material region 110 and the upper surface 122 of material region 120 are similarly planar. On the other hand, the upper surface 112 of material region 110 and the lower surface 121 of material region 120 may be angled to match the natural anatomical shape of the vertebrae that abut the respective surfaces 112, 121. Material regions 110 and 120 may have respective peripheral surfaces, such as surfaces 113 and 123, that are substantially planar with each other and with the peripheral surface 133 of intermediate region 130. In some embodiments, a through hole (not shown) may be formed through implant 100, extending from the upper surface 112 of material region 110, through intermediate region 130, to the lower surface 121 of material region 120. Although implant 100 is illustrated and described as having three separate regions 110, 120, 130, it should be appreciated that in some embodiments implant 100 has less than two, i.e., one or two regions, or more than three regions, such as four, five, or six or more regions. Additionally, although implant 100 is illustrated and described as a spinal implant, the implant may be formed in accordance with the present disclosure as a different type of orthopedic implant, such as a knee implant.

[0015] Material regions 110 and 120 may comprise similar or the same biocompatible material that is porous to promote tissue ingrowth and fixation of implant 100. Exemplary materials that may be used to form material regions 110 and 120 include, but are not limited to, metals such as titanium, stainless steel, cobalt chromium and / or tantalum; polymers such as ultra-high molecular weight polyethylene (UHMWPE), other forms of polyethylene, polyaryletherketones (PAEK) such as polyetheretherketone (PEEK), polycarbonate urethane (PCU), polylactic acid (PLA) and / or polyglycolic acid (PGA); and / or ceramics such as hydroxyapatite (HA), high density alumina, so-called "bioglass" and graphite. The porosity of material regions 110, 120 may be altered to change the tissue ingrowth characteristics into material regions 110, 120. The porosity of material regions 110, 120 may be, for example, 30%-70% to promote tissue ingrowth into material regions 110, 120. One exemplary material that may be used to form material regions 110, 120 is commercially available under the trade name OSTEOSYNC® from SITES MEDICAL® of Columbia City, Indiana.

[0016] The intermediate region 130 may include a porous biocompatible material similar to the material regions 110, 120. The porous biocompatible material may have a different stiffness than the material regions 110, 120, which may be higher or lower than the material regions 110, 120. In this sense, the intermediate region 130 may function as a stiffness tuning core to provide the implant 100 with a desired stiffness. The desired stiffness is generally different than the stiffness in the material regions 110, 120. As used herein, the "stiffness" of a material corresponds to the Young's modulus (E) of the material of the regions 110, 120, 130. In some embodiments, the intermediate region 130 has a relatively high stiffness material compared to the material regions 110, 120, such as titanium, cobalt chrome, PEEK, or polycarbonate urethane. The stiffness of the intermediate region 130 may be higher than the material regions 110, 120. This can be done, for example, by having intermediate region 130 have a different material composition comprising a generally stiffer material than material regions 110, 120, by varying the shape of intermediate region 130 as compared to material regions 110, 120, and / or by forming material regions 110, 120 and / or intermediate region 130 with stiffness tuning features as described further herein. In some embodiments, intermediate region 130 has the same material composition as material regions 110, 120, but is formed with a lower porosity such that intermediate region 130 has a stiffness greater than material regions 110, 120. In some embodiments, intermediate region 130 has a relatively lower stiffness material as compared to material regions 110, 120 to reduce the overall stiffness of implant 100. It should be appreciated that intermediate region 130 may have one or more regions of relatively higher stiffness material and one or more regions of relatively lower stiffness material to provide desired stiffness characteristics.

[0017] 3, another exemplary embodiment of an orthopedic implant 300 is shown. The orthopedic implant 300 is similar to the orthopedic implant 100, but is formed with a porous intermediate region 330 having a tapered lower surface 331 and a tapered upper surface 332 to define a lordosis angle Lα. The intermediate region 330 is disposed between a first porous ingrowth material region 310 and a second porous ingrowth material region 320. The material region 310 may have a flat lower surface 311 connected to the tapered upper surface 332 of the intermediate region 330, and the material region 320 may have a flat upper surface 322 connected to the tapered lower surface 331 of the intermediate region 330. In this sense, the lordosis angle Lα defined by the tapered surfaces 331, 332 of the intermediate region 330 defines the lordosis angle of the implant 300. Intermediate region 330 may be configured to define a lordosis angle Lα ranging from, for example, 3° to 15° depending on the patient's anatomy at the implantation site. Other than providing implant 300 with lordosis angle Lα, implant 300 may be configured similarly to implant 100 shown in Figures 1 and 2 and may have intermediate region 330 to adjust implant stiffness, and therefore further description will be omitted for the sake of brevity.

[0018] 4 and 5, another exemplary embodiment of an implant 400 formed in accordance with the present disclosure is shown. The implant 400 may be formed as a flat spinal implant similar to those previously described, including a first porous ingrowth material region 410, a second porous ingrowth material region 420, and a porous intermediate region 430 disposed between the material regions 410 and 420. Although shown formed as a flat implant, in some embodiments, the implant 400 is provided with a lordotic angle.

[0019] The implant 400 may have through holes 501 (shown in FIG. 5) extending from top to bottom through the ingrowth material regions 410, 420 and the intermediate region 430, and one or more additional openings 434 formed through the periphery 433 of the intermediate region 430 to adjust the stiffness of the intermediate region 430 and thus the overall stiffness of the implant 400. In some embodiments, the additional openings 434, which may be referred to as "stiffness adjustment features," extend through the intermediate region 430 from one side, such as side 435A, to the opposite side 435B of the intermediate region 430. In this regard, the stiffness adjustment features 434 are voids formed in the intermediate region 430 that reduce the overall stiffness of the implant 400, the significance of which will be further explained herein. The stiffness adjustment features 434 define a volume of material removed from the intermediate region 430 that may be adjusted to provide a desired stiffness to the implant 400. The volume of material removed from intermediate region 430 to achieve the desired stiffness may depend, for example, on the material composition of intermediate region 430 and the desired stiffness characteristics. Thus, while stiffness adjustment feature 434 is shown as an opening of constant rectangular cross-section formed through intermediate region 430, it should be appreciated that stiffness adjustment feature 434 may have other cross-sectional shapes that may vary across intermediate region 430. Additionally, while stiffness adjustment feature 434 is shown as formed in intermediate region 430, it should be appreciated that one or more stiffness adjustment features may be formed in material regions 410, 420. In other respects, implant 400 may be similar to implants 100 and 300 described above.

[0020] 6A and 6B, another exemplary embodiment of an orthopedic implant 600 formed in accordance with the present disclosure is shown. Unlike the previously described implants 100, 300, and 400, the orthopedic implant 600 may have a shape formed with substantially one porous ingrowth material body 610, i.e., the implant 600 does not have a separate porous intermediate region between two porous ingrowth material regions. The material body 610 may include similar materials as previously described ingrowth material regions, such as the ingrowth material region 110. As illustrated, the material body 610 may have a through hole 611 extending through the material body 610 from the upper surface 612 to the lower surface 613, and may be a feature for bone graft placement and / or a stiffness adjustment feature that may change the overall stiffness of the material body 610. The body of material 610 may have one or more perimeter surfaces, such as perimeter surface 614, formed with one or more additional stiffness adjustment features, such as apertures 615A, 615B, extending through perimeter surface 614. In some embodiments, apertures 615A, 615B are the same size and shape and both extend to through hole 611. Perimeter surface 614 may have a threaded aperture 616 formed therein, for example, to couple with an instrument for placement of implant 600 at an implantation site.

[0021] In some embodiments, the implant 600 further includes one or more reinforcing elements, shown as pins 620A, 620B, 620C, to increase the strength of the implant 600 in a certain direction. As shown in FIG. 6B, for example, the pins 620A, 620B, 620C may be disposed in corresponding pin openings 621A, 621B, 621C extending from the upper surface 612 toward the lower surface 613 of the body of material 610. The pins 620A, 620B, 620C may include, for example, titanium, PEEK, or another type of relatively high strength material. As can be appreciated, the body of material 610 includes a cavity (through hole 611) formed therein with a significant volume. The cavity 611 provides the body of material 610 with desired bone graft placement and stiffness characteristics, for example, in the midline-lateral and anterior-posterior directions, while the torsional, shear, or compressive strength of the body of material 610 may be insufficient without the reinforcement. That is, pins 620A, 620B, 620C may be provided to strengthen material body 610 in the compressive direction, such that implant 600 has sufficient compressive strength to withstand normal loads without significant risk of failure.

[0022] 7, another exemplary embodiment of an orthopedic implant 700 formed in accordance with the present disclosure is shown. The orthopedic implant 700 has a similar shape to the implant 600 shown in FIGS. 6A and 6B, but similar to the implants 100, 300, and 400 described above, includes a pair of porous ingrowth material regions 710, 720 with a porous or non-porous intermediate region 730 disposed therebetween. The material regions 710, 720 may include a material similar to the material regions 110, 120 described above, for example, and the intermediate region 730 may include a material similar to the intermediate region 130 described above, for example. In some embodiments, the material of the intermediate region 730 has a different stiffness than the material of the material regions 710 and 720.

[0023] The implant 700 may have a through hole 701 extending from the upper surface 712 of the material region 710 through the intermediate region 730 to the lower surface 721 of the material region 720. The intermediate region 730 may have an additional stiffness adjustment feature shown as a pair of openings 731A, 731B formed in a circumferential surface 732 and another opening 733 formed in another circumferential surface 734. The openings 731A, 731B may have the same or similar size and shape as each other, but may differ in size and shape from the opening 733. In this regard, the openings 731A, 731B, 733 formed in the intermediate region 730 may have different effects on the stiffness of the intermediate region 730 and, therefore, the stiffness of the implant 700. In some embodiments, the circumferential surface 732 also has a threaded opening 735 formed therein, for example, for coupling to an insertion tool for inserting the implant 700.

[0024] Referring to FIG. 8, another exemplary embodiment of an orthopedic implant 800 formed in accordance with the present disclosure is shown. The orthopedic implant 800 may be formed with a porous ingrowth material body 810, similar to the implant 600 described above. The material body 810 may be formed with one or more peripheral surfaces 811 having notches 812 formed therein. A reinforcing material 820, including a material having a higher strength than the material of the material body 810, may be disposed in the notches 812 to reinforce the implant 800 and increase the strength of the implant 800. In this regard, the reinforcing material 820 contacts the boundary surfaces of the notches 812 and functions similar to a window frame to increase the strength of the material surrounding the notches 812, rather than having, for example, a reinforcing pin. In other respects, the implant 800 may be similar to the implant 600, and thus further description will be omitted for the sake of brevity.

[0025] 9-12, additional exemplary embodiments of orthopedic implants 900, 1000, 1100, 1200 formed in accordance with the present disclosure are shown. As shown, each implant 900, 1000, 1100, 1200 has a respective first porous ingrowth material region 910, 1010, 1110, 1210, a respective second porous ingrowth material region 920, 1020, 1120, 1220, and a respective porous or non-porous intermediate region 930, 1030, 1130, 1230 disposed between the material regions 910, 920, 1010, 1020, 1110, 1120, 1210, 1220. The material regions 910, 920, 1010, 1020, 1110, 1120, 1210, 1220 may, for example, comprise the same material as the material regions 110 and 120 discussed above, and the intermediate regions 930, 1030, 1130, 1230 may, for example, comprise the same material as the intermediate region 130 discussed above. As illustrated, the implants 900, 1000, 1100, 1200 may be formed to have a substantially dome shape. Each implant 900, 1000, 1100, 1200 may be formed with a through opening 901, 1001, 1101, 1201 extending from an upper surface 902, 1002, 1102, 1202 to a lower surface 903, 1003, 1103, 1203 of the implant 900, 1000, 1100, 1200. Rather than leaving the voids empty, one or more reinforcing ribs 904A, 904B, 1004A, 1004B, 1104A, 1104B, 1204A, 1204B may be disposed in the voids formed by the through openings 901, 1001, 1101, 1201. In some embodiments, the ribs 904A, 904B, 1004A, 1004B, 1104A, 1104B, 1204A, 1204B are formed as a result of forming the through openings 901, 1001, 1101, 1201. Additionally, one or more stiffness adjustment features such as openings 931A, 931B, 931C, 931D, 1031A, 1031B, 1031C, 1031D, 1131A, 1131B, 1231A, 1231B, 1231C, 1231D may be formed in the intermediate region 930, 1030, 1130, 1230 and may extend to the through openings 901, 1001, 1101, 1201.A threaded opening 932A, 932B, 1032A, 1032B, 1132, 1232A, 1232B may be formed in the intermediate region 930, 1030, 1130, 1230 for cooperation with an insertion tool for inserting the implant 900, 1000, 1100, 1200 at the implant site.

[0026] 9, implant 900 has reinforcing ribs 904A, 904B that may be formed from the same material as intermediate region 930, thereby modifying the stiffness of implant 900, for example, as compared to when the void formed by through opening 901 is left empty. Ribs 904A, 904B may be partially covered on the upper side by material region 910 and on the lower side by material region 920. As illustrated, ribs 904A, 904B may be solid, i.e., formed without a void.

[0027] 10, it can be seen that intermediate region 1030 is "wrapped" by porous ingrowth material region 1040. Porous ingrowth material region 1040 may comprise materials similar to those of material regions 1010, 1020. As illustrated, wrapping material region 1040 may wrap some or all of the outer diameter 1033 of intermediate region 1030 to provide a more porous material in intermediate region 1030 for tissue ingrowth. In other respects, implant 1000 may be similar to implant 900.

[0028] 11, it can be seen that the implant 1100 has reinforcing ribs 1104A, 1104B formed with rib notches 1105A, 1105B to reduce the stiffness of the respective ribs 1104A, 1104B. In all other respects, the implant 1100 may be similar to the implant 900.

[0029] 12, the intermediate region 1230, similar to the intermediate region 1030 of the implant 1000, is "wrapped" about some or all of the outer diameter 1233 of the intermediate region 1230 by a porous ingrowth material region 1240. The implant 1200 further includes another porous ingrowth material region 1250 "wrapped" about some or all of the inner diameter 1234 of the intermediate region 1230, such that both the outer diameter 1233 and the inner diameter 1234 of the intermediate region 1230 are at least partially wrapped in the porous ingrowth material. In other respects, the implant 1200 may be similar to the implant 1000.

[0030] It has been found that in many instances, the stiffness of an orthopedic implant does not need to be as high as possible to promote healing in a patient. Rather, in some instances, an implant formed with too high a stiffness can harm a patient. For example, in a spinal implant, an implant with excessively high stiffness can lead to damage to the vertebral endplates of the spine after implantation, even under loads that would not normally damage the endplates. This type of damage occurs because the excessive stiffness of the implant transfers excessive loads to the surrounding anatomical structures, rather than deforming to absorb some of the load. The excessive transferred loads can lead to cases where the surrounding bone is stressed higher than normal and damaged when subjected to loads that would not normally cause damage.

[0031] On the other hand, the stiffness of the implant must be high enough to support the surrounding anatomical structures. If the stiffness of the implant is too low, the implant will not provide adequate support for the spine, which may lead to abnormal curvature of the spine and significantly increase the risk of spinal injuries. This makes the stiffness of the implant particularly important when designing the implant, because too high or too low stiffness tends to increase the risk of side effects after implantation.

[0032] In relation to this discovery, the implants 100, 300, 400, 600, 700, 800, 900, 1000, 1100 and 1200 formed in accordance with the present disclosure may have a stiffness that is not too high that may lead to abnormal bone damage, but not so low that the surrounding anatomical structures are not adequately supported. The stiffness of the implants 100, 300, 400, 600, 700, 800, 900, 1000, 1100 and 1200 may be adjusted as described above to provide a desired stiffness. This allows the implants 100, 300, 400, 600, 700, 800, 900, 1000, 1100 and 1200 formed in accordance with the present disclosure to adequately support the surrounding anatomical structures after implantation without abnormal risk of damaging the surrounding bone.

[0033] In some exemplary embodiments, a method is provided for forming an orthopedic implant with a patient-tuned stiffness. As used herein, "patient-tuned" stiffness may refer to the stiffness of an implant provided for a particular patient, i.e., a single patient, or a particular patient population, i.e., a population of patients sharing a common medically significant characteristic, such as having osteoporosis, scoliosis, and / or arthritis. To form an implant, such as the orthopedic implant 100, a magnitude of stiffness required by the implant to treat the patient is determined. Determining the stiffness may include, for example, evaluating the condition of the patient's anatomy and the patient's medical history. Determining may include, for example, visualizing the patient's anatomy at the implantation site using magnetic resonance imaging (MRI) or x-ray imaging techniques to determine the progression of disease in the patient and the shape of the anatomical features surrounding the implantation site. In some embodiments, determining the stiffness may include comparing the condition of the patient's anatomy to a comparable patient's anatomy and deriving a stiffness from the comparison. Thus, it should be appreciated that many different techniques may be used to determine the stiffness required to treat a patient. In some embodiments, the required stiffness may be similar to the stiffness of the patient's natural anatomy, e.g., the stiffness of the patient's vertebrae, such that the manufactured implant has a "coefficient match" with the patient's anatomy.

[0034] Once the required stiffness is determined, the implant may be formed such that the formed implant has the required stiffness. In some embodiments, forming the implant includes providing an implant having a shape and modifying the implant to have the required stiffness. Modifying the implant may include forming one or more stiffness adjusting features in the implant, for example, as described above. Modifying the implant may include adjusting the material that forms one or more regions of the implant, such as the porous ingrowth material region or intermediate region, for example, by changing the porosity, by changing the shape, or by changing the composition of the material being adjusted. After the implant with the required stiffness is formed, the implant may be sent to a healthcare provider, such as a surgeon, for implantation into the patient at the implantation site.

[0035] From the foregoing, it should be appreciated that the present disclosure provides a method of manufacturing an implant with appropriate stiffness for a desired application. The method allows for the manufacture of an implant that is not so stiff that abnormal fracture becomes a significant problem, while also providing sufficient support for the surrounding anatomical structures. That is, the implant can be manufactured with appropriate stiffness to heal the patient after implantation without significantly increasing the risk of adverse effects such as abnormal fracture.

[0036] In some embodiments, a method is provided for manufacturing a plurality of orthopedic implants, such as the implant 300 shown in FIG. 3. Each of the manufactured implants may have a similar stiffness and shape, as will be appreciated from further description provided herein. With particular reference now to FIGS. 13-15, it can be seen that the method may include manufacturing a strip of material 1301 that is used to form the implant 300. The strip of material 1301 may be, for example, a composite of a first porous ingrowth material 1310, a second porous ingrowth material 1320, and a porous intermediate material 1330 disposed between the ingrowth materials 1310, 1320. The intermediate material 1330 may be formed with upper and lower surfaces that define the lordosis angle Lα of the implant 300, as previously described. In some embodiments, a plurality of retention openings 1302, 1303 are formed at opposing ends 1304, 1305 of the strip 1301 for holding the strip 1301, for example, by clamps.

[0037] 15, it can be seen that a plurality of through openings 1501 are formed in the strip 1301. Each through opening 1501 corresponds to an implant formed from the strip 1301, i.e., there are nine through openings 1501 formed in the strip 1301 corresponding to the nine implants formed from the strip 1301. The through openings 1501 may be formed in the strip 1301 in any suitable manner, for example, by drilling, machining, etc. In some embodiments, the materials 1310, 1320, 1330 forming the strip 1301 have openings formed therein prior to bonding to form through openings through the strip 1301.

[0038] To form implants from the strip 1301, individual implants are cut from the strip 1301 into the shape of the final implant. As shown in FIG. 15, for example, the strip 1301 can be cut along parting lines 1502 to form a plurality of implant blanks 1503. After the implant blanks 1503 are separated from one another, the implant blanks 1503 can be machined into the final implant shape, if necessary, or packaged and sterilized before being shipped for implantation. In some embodiments, one or more of the implant blanks 1503 can be treated to adjust the stiffness of the final implant, as described above.

[0039] Referring to FIG. 16, another exemplary embodiment of a strip 1601 that may be used to form a flat implant, i.e., an implant without a lordotic angle, is shown, for example, to manufacture the implant 100 shown in FIGS. 1 and 2. The strip 1601 is formed having a first porous ingrowth material 1610, a second porous ingrowth material 1620, and a porous intermediate material 1630 disposed between the ingrowth materials 1610, 1620. The porous intermediate material 1630 is provided with a flat upper surface and a flat lower surface, such that the manufactured implant does not define a lordotic angle. In all other respects, the strip 1601 may be used to manufacture a plurality of individual implants similar to the strip 1301 described above.

[0040] From the above, it should be appreciated that the present disclosure provides a method for manufacturing multiple implants from one source of material, which may be a strip, sheet, or blank. The source of material may be readily available to the manufacturer and processed when needed to produce an implant with a desired shape and stiffness. Strips of material, for example, may be available to the manufacturer to manufacture implants when needed, reducing the need to store many different materials. Thus, it should be appreciated that the above method may increase production speed and reduce production costs by providing an easily handled and processed material that can be rapidly processed to manufacture one or more implants.

[0041] While the invention has been described with respect to at least one embodiment, the invention can be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.

Claims

1. 1. An orthopedic implant, comprising: a first porous ingrowth material region; a second porous ingrowth material region coupled to the first porous ingrowth material region; an intermediate region disposed between the first and second porous ingrowth material regions; Equipped with the intermediate region is non-porous or porous having a porosity lower than the porosity of the first porous ingrowth material region and / or the porosity of the second porous ingrowth material region; the intermediate region has a different stiffness than at least one of the first porous ingrowth material region or the second porous ingrowth material region; the first porous ingrowth material region having an upper surface located on a vertebra; the second porous ingrowth material region having an inferior surface that rests on a vertebra; the orthopedic implant further comprises at least one stiffness tuning feature formed in at least one of the intermediate region, the first porous ingrowth material region, or the second porous ingrowth material region; the at least one stiffness adjustment feature is an opening. Orthopedic implants.

2. the intermediate region is porous having a porosity lower than the porosity of the first porous ingrowth material region and / or the porosity of the second porous ingrowth material region; 10. The orthopedic implant of claim 1.

3. the stiffness of the intermediate region is greater than the stiffness of the first porous ingrowth material region and the stiffness of the second porous ingrowth material region; 10. The orthopedic implant of claim 1.

4. the stiffness of the intermediate region is less than the stiffness of the first porous ingrowth material region and the stiffness of the second porous ingrowth material region; 10. The orthopedic implant of claim 1.

5. the opening extends from an upper surface of the first porous ingrowth material region through the intermediate region to a lower surface of the second porous ingrowth material region; 10. The orthopedic implant of claim 1.

6. a cavity is defined by the opening, and at least one reinforcing rib is disposed in the cavity.

6. The orthopedic implant of claim 5.

7. the at least one reinforcing rib has a rib notch formed therein.

7. The orthopedic implant of claim 6.

8. the intermediate region being wrapped around at least a portion of an outer diameter of the intermediate region by a wrapping porous ingrowth material region; 10. The orthopedic implant of claim 1.

9. the intermediate region having a tapered upper surface connected to the first porous ingrowth material region and a tapered lower surface connected to the second porous ingrowth material region to define a lordosis angle.

10. The orthopedic implant of claim 1.

10. 1. A method of manufacturing a plurality of orthopedic implants, the method comprising: manufacturing a strip of material comprising a composite of a first porous ingrowth material, a second porous ingrowth material, and an intermediate region disposed between the first and second porous ingrowth materials; forming a plurality of through openings in the strip; cutting a plurality of implant blanks from the strip, each implant blank having at least one of the through apertures formed therethrough; Including, the first porous ingrowth material and / or the second porous ingrowth material are polymeric, metallic and / or ceramic; the intermediate region is non-porous or porous having a porosity lower than the porosity of the first porous ingrowth material and / or the porosity of the second porous ingrowth material; method.

11. The implant blanks each have a similar shape. The method of claim 10.

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