Porous Interbody Spacer

Abstract

Orthopedic implants, particularly interbody spacers, have a combination of correct pore size and stiffness/flexibility. When the implants have the proper pore size and stiffness, osteocytes are able to properly bridge the pores of the implant and then experience a proper compressive load to stimulate the bone cells to form bone within the pores. An implant includes a body formed of an osteoconductive material and having a stiffness of between 400 megapascals (MPa) and 1,200 MPa. Additionally, the body includes a plurality of pores having an average size of between 150 microns and 600 microns. The pores permit the growth of bone therein. The body is formed of packs of coils which may be formed using an additive manufacturing process and using traditional orthopedic implant materials such as titanium and titanium alloys while still achieving desired stiffness and pore sizes of the implants.

Claims

1. An implant comprising: a body formed of an osteoconductive material; the body comprising a stiffness of between 400 megapascals (MPa) and 1,200 MPa; and the body comprising a plurality of pores having an average size of between 150 microns and 600 microns.

2. The implant as recited in claim 1, wherein the osteoconductive material comprises a material selected from the group consisting of titanium, tantalum, and alloys thereof.

3. The implant as recited in claim 1, wherein the osteoconductive material comprises a material selected from the group consisting of titanium and alloys thereof.

4. The implant as recited in claim 1, wherein the implant comprises a stiffness of between 600 MPa and 1,000 MPa.

5. The implant as recited in claim 1, wherein the implant comprises a stiffness of between 750 MPa and 850 MPa.

6. The implant as recited in claim 5, wherein the implant comprises a stiffness of between 950 MPa and 1,050 MPa.

7. The implant as recited in claim 1, wherein the implant is manufactured using an additive manufacturing process.

8. The implant as recited in claim 1, wherein the implant comprises a coil spring construction.

9. The implant as recited in claim 8, wherein the coil spring construction comprises a vertical spacing between coils of between 250 microns and 350 microns.

10. The implant as recited in claim 8, wherein the coil spring construction comprises a coil diameter of between 400 microns and 600 microns.

11. The implant as recited in claim 1, wherein the implant comprises a nested coil spring construction.

12. The implant as recited in claim 1, wherein the implant comprises a plurality of overlapping coil packs.

13. The implant as recited in claim 10, wherein the plurality of overlapping coil packs comprise coils that are connected and coils that are intertwined without connecting.

14. The implant as recited in claim 1, wherein the implant comprises a plurality of coil springs joined in clockwise to counter-clockwise sweep directions.

15. The implant as recited in claim 14, wherein the implant is an interbody spacer.

16. An implant comprising: a body comprising a plurality of coil springs formed of an osteoconductive material; the body comprising a stiffness of between 400 megapascals (MPa) and 1,200 MPa; and the body comprising a plurality of pores having an average size of between 150 microns and 600 microns.

17. The implant as recited in claim 16, wherein the osteoconductive material comprises a material selected from the group consisting of titanium and alloys thereof.

18. The implant as recited in claim 16, wherein the implant comprises a stiffness of between 750 MPa and 1,050 MPa.

19. The implant as recited in claim 16, wherein the implant is manufactured using an additive manufacturing process.

20. An implant comprising: a body comprising a plurality of coil springs manufactured using an additive manufacturing process; the coil springs being arranged into a plurality of overlapping coil packs comprising coils that are connected and coils that are intertwined without connecting; the coil springs comprising coils having a clockwise sweep direction and coils having a counterclockwise sweep direction; the body comprising a stiffness of between 400 megapascals (MPa) and 1,200 MPa; and the body comprising a plurality of pores having an average size of between 150 microns and 600 microns.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0031] The objects and features of the present invention will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only typical embodiments of the invention and are, therefore, not to be considered limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0032] FIG. 1 shows a force-displacement graph of various bulk materials;

[0033] FIG. 2 shows a perspective view of a representative implant;

[0034] FIG. 3 shows a top view of the implant of FIG. 2;

[0035] FIG. 4 shows a perspective view of various coil packs for use with implants;

[0036] FIG. 5 shows a cross-sectional view of an illustrative coil pack;

[0037] FIG. 6 shows a perspective view of illustrative adjacent coil packs having clockwise and counter-clockwise sweep directions; and

[0038] FIG. 7 shows a perspective view of illustrative alternate coil packs.

DETAILED DESCRIPTION OF THE INVENTION

[0039] A description of embodiments of the present invention will now be given with reference to the Figures. It is expected that the present invention may take many other forms and shapes, hence the following disclosure is intended to be illustrative and not limiting, and the scope of the invention should be determined by reference to the appended claims.

[0040] Embodiments of the invention provide orthopedic implants, particularly implemented in the current examples as interbody spacers, the implants having a combination of correct pore size and stiffness/flexibility. Embodiments of the invention also provide methods for producing such orthopedic implants. When the implants have the proper pore size and stiffness, osteocytes are able to properly bridge the pores of the implant and then experience a proper compressive load to stimulate the bone cells to form bone within the pores throughout the implants according to Wolff's law.

[0041] According to embodiments of the invention, an implant includes a body formed of an osteoconductive material. The body may have a stiffness of between 400 megapascals (MPa) and 1,200 MPa. Additionally, the body may include a plurality of pores having an average size of between 150 microns and 600 microns. The pores may be interconnected and permit the growth of bone therein. The implant may be an interbody spacer.

[0042] The osteoconductive material may be any of a variety of materials such as titanium, tantalum, and alloys thereof or titanium and alloys thereof such as, for example Ti 6-4 (approximately 6% aluminum, 4% vanadium, up to 0.25% iron, up to 0.2% oxygen and the remainder titanium) and other recognized alloys used for implants. Alternatively, the osteoconductive material may be any material now known or later discovered to be biocompatible and osteoconductive and providing characteristics in line with those discussed herein. In certain embodiments, the implant has a stiffness of between 600 MPa and 1,000 MPa. In other embodiments, the implant has a stiffness of between 750 MPa and 850 MPa. In still other embodiments, the implant has a stiffness of between 950 MPa and 1,050 MPa. In additional embodiments, the implant has a stiffness of between 750 MPa and 1,050 MPa.

[0043] The implant may be manufactured using an additive manufacturing process. The implant may have a coil spring construction. The coil spring construction may have a vertical spacing between coils of between 250 microns and 350 microns. The coil spring construction may have a coil diameter of between 400 microns and 600 microns. The implant may have a nested coil spring construction. The implant may also or alternatively have a plurality of overlapping coil packs. Where present, the plurality of overlapping coil packs may include coils that are connected and coils that are intertwined without connecting. The implant may have a plurality of coil springs joined in clockwise to counter-clockwise sweep directions.

[0044] According to alternate embodiments of the invention, an implant includes a body comprising a plurality of coil springs formed of an osteoconductive material. The body may have a stiffness of between 400 MPa and 1,200 MPa. The body may also include a plurality of pores having an average size of between 150 microns and 600 microns.

[0045] The osteoconductive material may be any of a variety of materials such as titanium, tantalum, and alloys thereof or titanium and alloys thereof. Alternatively, the osteoconductive material may be any material now known or later discovered to be biocompatible and osteoconductive and providing characteristics in line with those discussed herein. In certain embodiments, the implant has a stiffness of between 600 MPa and 1,000 MPa. In other embodiments, the implant has a stiffness of between 750 MPa and 850 MPa. In still other embodiments, the implant has a stiffness of between 950 MPa and 1,050 MPa. In additional embodiments, the implant has a stiffness of between 750 MPa and 1,050 MPa.

[0046] The implant may be manufactured using an additive manufacturing process. The coil springs of the body may have a vertical spacing between coils of between 250 microns and 350 microns. The coil springs of the body may have a coil diameter of between 400 microns and 600 microns. The implant may have a nested coil spring construction. The implant may also or alternatively have a plurality of overlapping coil packs. Where present, the plurality of overlapping coil packs may include coils that are connected and coils that are intertwined without connecting. The implant may have a plurality of coil springs joined in clockwise to counter-clockwise sweep directions.

[0047] According to alternate embodiments of the invention, an implant includes a body comprising a plurality of coil springs manufactured using an additive manufacturing process. The coil springs may be arranged into a plurality of overlapping coil packs having coils that are connected and coils that are intertwined without connecting. The coil springs may include coils having a clockwise sweep direction and coils having a counterclockwise sweep direction. The body may have a stiffness of between 400 MPa and 1,200 MPa. The body may have a plurality of pores having an average size of between 150 microns and 600 microns.

[0048] The osteoconductive material may be any of a variety of materials such as titanium, tantalum, and alloys thereof or titanium and alloys thereof. Alternatively, the osteoconductive material may be any material now known or later discovered to be biocompatible and osteoconductive and providing characteristics in line with those discussed herein. In certain embodiments, the implant has a stiffness of between 600 MPa and 1,000 MPa. In other embodiments, the implant has a stiffness of between 750 MPa and 850 MPa. In still other embodiments, the implant has a stiffness of between 950 MPa and 1,050 MPa. In additional embodiments, the implant has a stiffness of between 750 MPa and 1,050 MPa.

[0049] The coil springs of the body may have a vertical spacing between coils of between 250 microns and 350 microns. The coil springs of the body may have a coil diameter of between 400 microns and 600 microns. The implant may have a nested coil spring construction.

[0050] According to further embodiments of the invention, a method of manufacturing an implant includes a step of forming an implant body using an additive manufacturing process. The step of forming an implant body may include forming a plurality of coils of an osteoconductive material. The coils so formed may have a vertical coil spacing and a coil diameter chosen to impart certain physical characteristics to the implant while facilitating use of the additive manufacturing process. The implant body so formed may have a stiffness of between 400 MPa and 1,200 MPa, and may include a plurality of pores having an average size of between 150 microns and 600 microns.

[0051] In certain embodiments, the implant body so formed has a stiffness of between 600 MPa and 1,000 MPa. In other embodiments, the implant body so formed has a stiffness of between 750 MPa and 850 MPa. In still other embodiments, the implant body so formed has a stiffness of between 950 MPa and 1,050 MPa. In additional embodiments, the implant body so formed has a stiffness of between 750 MPa and 1,050 MPa.

[0052] The coil springs of the body may have a vertical spacing between coils of between 250 microns and 350 microns. The coil springs of the body may have a coil diameter of between 400 microns and 600 microns. The implant may have a nested coil spring construction.

[0053] The implant so formed may have a nested coil spring construction. The implant may also or alternatively have a plurality of overlapping coil packs. Where present, the plurality of overlapping coil packs may include coils that are connected and coils that are intertwined without connecting. The implant may have a plurality of coil springs joined in clockwise to counter-clockwise sweep directions.

[0054] As discussed above, it would be ideal for an implant to provide porosity and stiffness generally similar to actual bone using materials that are conducive to bone growth. In addition to an ideal pore size of 150 microns to 650 microns, an ideal implant would have a stiffness of between 400 MPa and 1.2 gigapascals (GPa) (1,200 MPa). Additionally, when pores are at the larger end of the ideal range, the implant will allow for the fastest and greatest extent of vascularization. Bones that experience larger loads generally have smaller pores and greater stiffness. To grow denser, stronger bone requires an implant with upper-range pore sizes and lower-range stiffness to allow the bone to experience more of the load. In this way, the implant avoids shielding bone within the implant from stress that would cause the bone to grow. Additionally, the larger pores allow the bone to better occupy the available space.

[0055] FIG. 1 shows a force-displacement graph of various materials, illustrating the stiffness of the various materials. The line with the steepest slope and thus greatest stiffness is bulk titanium. As shown in FIG. 1, the next stiffest materials are PEEK and trabecular metal (tantalum). In contrast, the stiffness of trabecular bone (shown as exhibiting a range of stiffnesses due to the varying stiffness of different areas of trabecular bone in the body) is still significantly less than even trabecular metal. In contrast, a tranquility implant in accordance with embodiments of the invention, though made from titanium or a titanium alloy in this example, achieves a stiffness near the lower end of the stiffness range of trabecular bone. As will be described further below, the exact configuration of coil springs, including coil spacing, etc., in the implant can be varied to achieve varying implant stiffnesses while achieving a desired pore sizesomething that cannot be achieved with other implant systems.

[0056] FIG. 2 shows a perspective view of an illustrative implant 10 demonstrating features in accordance with embodiments of the invention. FIG. 3 shows a top view of the illustrative implant 10. The illustrative implant includes a plurality of two types of coil packs arranged in an alternating arrangement. In the alternating arrangement, a first coil pack 12 having a clockwise sweep direction alternates with a second coil pack 14 having a counterclockwise sweep direction. Each coil pack 12, 14 may be formed of one spring coil or of a plurality of stacked concentric spring coils. In the example shown in FIGS. 2 and 3, each coil pack 12, 14 includes three spring coils.

[0057] FIG. 4 illustrates how illustrative coil packs may be formed of one or more spring coils. FIG. 4 illustrates three different exemplary coil packs. The left coil pack includes a single spring coil, namely first spring coil 30. The central coil pack includes two spring coils, namely first spring coil 30 and second spring coil 32. In this central example, the spring coils 30, 32 are concentric in that they have a common axis about which each spring coil 30, 32 winds. Each of the spring coils 30, 32 of the central example have a similar wire diameter, coil diameter, and vertical spacing, such that each turn of the coil pack is substantially identical, even though alternating turns of the coil pack are formed from alternating of the first spring coil 30 and the second spring coil 32. Alternatively, if desired, the wire diameter and/or coil diameter of the first spring coil 30 may differ from the wire diameter and/or coil diameter of the second spring coil 32 if desired to impart different stiffness or other characteristics to the implant 10 in which the coil pack is incorporated.

[0058] In any coil pack embodiment, the vertical spacing, wire diameter, and/or coil diameter may be varied as desired to vary the stiffness and other characteristics of the implant 10 in which the coil pack is incorporated. For example, in comparing the left coil pack of FIG. 4 to the middle coil pack of FIG. 4, it may be seen that the total number of wire turns in each example is similar, even though the turns of the central example are split between two spring coils while the turns of the left example are formed from a single spring coil. In each example of FIG. 4, the wire diameter and coil diameter is similar. The stiffness of each example is varied by the differing coil pitches achieved by having two spring coils as opposed to a single spring coil.

[0059] FIG. 4 includes a third example of a coil pack on the right side. This example is formed of four spring coils, namely first spring coil 30, second spring coil 32, third spring coil 34, and fourth spring coil 36. This example further illustrates that the number of spring coils forming each spring pack may be varied as desired, and it will be a matter of straightforward experimentation with varied numbers of spring coils, spring wire thickness, and vertical coil spacing to achieve a desired stiffness of each coil pack. In each of the coil packs of FIG. 4, the spring coils (and the coil packs themselves) have a clockwise sweep direction. Essentially identical coil packs may be formed having counter-clockwise sweep direction, even though such are not illustrated in FIG. 4.

[0060] The spring coils of each coil pack may assume any desired cross-sectional shape. For example, FIG. 5 shows a cross-sectional view of a four-wire coil pack formed of first spring coil 30, second spring coil 32, third spring coil 34, and fourth spring coil 36. In this example, the wire of each spring coil has a square cross-sectional shape with radiused edges, but essentially any cross-sectional shape may be used. For example, the spring coils may have a round cross-sectional shape, an elliptical cross-sectional shape, a square cross-sectional shape, a rectangular cross-sectional shape, or a cross-sectional shape of any desired number of sides (pentagonal, octagonal, etc.), with or without rounded or radiused edges. Further examples of illustrative shapes and configurations of spring coils and coil packs are shown in FIG. 7, as discussed below.

[0061] The coil pack or swept coil of each coil pack has a stiffness and strength that depends on the base diameter of the coil pack, which can be chosen to facilitate bone growth. The stiffness and strength are also dependent on the pitch of the coils in the coil pack, which can further be chosen to facilitate bone growth by defining a proper size space between coils. The stiffness and strength are also dependent on the wire diameter and modulus of rigidity of the chosen material. When coils are placed together to form coil packs, the needed pore spacing for bone growth is created while the bulk strength is increased and the bulk stiffness of the device is decreased.

[0062] Forming the body of the implant 10 as coil packs 12, 14 allows an additive manufacturing process to be used with traditionally biocompatible and osteoconductive materials (e.g. titanium and alloys thereof) while still maintaining a desired stiffness. Additionally, this type of construction allows the additive manufacturing process to be used while still achieving the desired pore size. Traditionally, additive manufacturing processes were incapable of being used to provide the desired pore size. Specifically, the pores of prior devices were conceived in negative, thus limiting the pore size to the minimum feature size of the additive manufacturing process, which in turn determines the bulk stiffness (typically much higher than the stiffness of trabecular bone).

[0063] Using the coil pack construction discussed herein allows for the creation of pores by stacking overlapping geometry. In effect, the overlapping geometry allows the pore size to be smaller and better shaped without reducing the minimum feature size of the additive manufacturing process. While the smaller pore size achieved in this way would traditionally increase stiffness, the clever geometry of the coil packs allows the bulk flexibility to be increased as governed by the following equation:

[00001]$T=\frac{J_T}{r}.Math.=\frac{J_T}{}.Math.G.Math..Math.$

[0064] In this way, the implant 10 may have a micro-porous structure effectively formed of flexible micro struts that in concert decrease the bulk stiffness of the device, allowing for use of osteoconductive materials such as Ti 6-4, tantalum, or other alloys of titanium or tantalum. The pore size thus achieved is large enough for vascularization and rapid bone growth, and not too large for bone bridging, and the bone is able to grow both on and throughout the device. The contact area between the device and the bone can be increased, mitigating overloading of local bone at the bone-to-device interface.

[0065] As illustrated in FIGS. 2 and 3, the coil packs 12, 14 may be arranged in a way so as to overlap/intersect. This overlapping/intersecting of clockwise and counter-clockwise sweeping coil packs is illustrated in more detail in FIG. 6. In this Figure, a full set of coil packs is shown at the left, and the right shows what may either be an entire set of coil packs, or merely a single set of spring coils from the coil pack at the left of FIG. 6. In the left illustrated example of FIG. 6, the first coil pack 12 has four individual spring coils, namely, first spring coil 30, second spring coil 32, third spring coil 34 and fourth spring coil 36, all having a clockwise sweep direction, while the second coil pack 14 has three individual spring coils, namely, first spring coil 40, second spring coil 42, and third spring coil 44. Thus, the first coil pack 12 has an additional spring coil, fourth spring coil 36 that is unpaired and has no corresponding spring coil in the second coil pack 14. This may be by design to decrease stiffness of the implant 10 containing the joined coil packs 12, 14.

[0066] As may be seen in FIG. 16, and particularly in the single-spring-coil example at the right of FIG. 6, the individual spring coils of each coil pack 12, 14 may be unitarily formed or joined at their points of intersection. As the implant 10 is formed in the additive manufacturing process, the individual coils of the coil pack are unitarily formed such that while the coils of the coil packs may be conceptually viewed as separate coils, they are actually united in a way that provides a measure of overall structure to the implant 10. Additionally, this construction overcomes limitations of the additive manufacturing process, allowing for creation of the ideal pore size. This type of construction effectively avoids the additive manufacturing process's limitations, as the additive manufacturing process views each spring coil as an independent structure. The overlapping coil packs have the added advantages of tailored shear stiffness and strength as well as load sharing between adjacent coil packs.

[0067] The top view of the implant 10 shown in FIG. 3 illustrates how the coils of adjacent coil packs are joined at one cross-sectional point, namely, the top surface of the implant 10. In this Figure, the third spring coil 34 of one of the first coil packs 12 is joined to the third spring coil 44 of one of the second coil packs 14. The second spring coil 32 of that first coil pack 12 is joined to the second spring coil 42 of a different second coil pack 14, and the first spring coil 30 of that first coil pack 12 is joined to the first spring coil 40 of yet another different second coil pack 14. Thus each coil pack 12, 14 is unitarily formed on all sides to the coil packs 14, 12 adjacent to them, respectively, forming the implant 10 as a unitary, though relatively flexible body.

[0068] If desired, the implant 10 may include some areas of additional structure, rigidity, and strength at locations where the normal increased flexibility is not needed or is not desired. For example, the implant 10 shown in FIGS. 2 and 3 may include an outer bottom rim 20, an inner bottom rim (not shown) an outer top rim 22, and an inner top rim 24. The inner top rim 24 and the inner bottom rim may define top and bottom edges of a void adapted to receive a bone graft material such as morcellized bone (living bone) prior to implantation of the implant 10, thereby providing a seed to better initiate bone growth into the implant 10 after implantation, as is known in the art. Additionally, the implant 10 may include a rigid strut 26 formed on one side of the implant 10, if it is determined that the implant 10 should be more rigid on one side thereof.

[0069] As discussed above, the cross-sectional form of each coil spring may be varied, and the configuration of the coil packs may also take other forms as long as they achieve the purposes discussed herein. To this end, FIG. 7 illustrates alternate embodiments of coil packs that could be used with embodiments of the implant 10. The left coil pack of FIG. 7 includes first spring coil 30, second spring coil 32, third spring coil 34, and fourth spring coil 36, as did one of the examples of FIG. 4. In this example, however, the spring coils 30, 32, 34, and 36 have a non-rounded square cross-sectional profile.

[0070] In the right coil pack of FIG. 7, the coil pack includes a first diamond structure 50 and a second diamond structure 52, illustrating that the coil packs need not be formed solely of standard sweep coils, but that coil packs may be formed of any microstructure that is capable of being manufactured using an additive manufacturing process while providing a proper pore size and bulk stiffness. The interlocking diamond shape of the right coil pack of FIG. 7 achieves this in a different fashion than the coil packs illustrated and discussed previously, but still provides an interlocking structure and a known small pore size within the constraints of existing additive manufacturing processes.

[0071] The illustrated implant embodiment of FIGS. 2 and 3 is an interbody spacer aimed at facilitating bony fusion of adjacent segments of the spine. The implant 10 can be placed in an intervertebral space to provide support to the spine during bone growth, but furthermore can work to promote and stimulate bone growth. Unlike prior devices, the implant 10 can simultaneously promote and stimulate bone growth throughout the device (not just onto the surface of the device) while maintaining stable support.

[0072] It is envisioned that the systems and methods illustrated herein may be useful in other types of orthopedic implants, and that the stiffness and pore sizes may be modified as appropriate to achieve the desired characteristics at the location where such implants are to be used.

[0073] The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.