Implant for supporting anatomic structures

Abstract

An implant material for use in stabilizing anatomic structures comprises a plurality of fenestrated shells. The anatomic structures may be bone defects, vertebral bodies, or spinal disks. The implant material may further comprise a particulate filler material that may comprise particulate bone.

Description

IMPLANT FOR SUPPORTING ANATOMIC STRUCTURESBACKGROUND

[0001] Osteoporosis has continued to be a ubiquitous problem, especially in the elderly population. It is said that osteoporosis sufferers outnumber patients in the United States who have had Ml's, stroke, and breast cancer combined. Osteoporosis can result in compression fractures of the vertebral bodies of the spinal column. As shown in FIG. 1 , these fractures 10 generally occur in the anterior portion of the vertebra, with this portion compressing to a smaller height than a normal vertebral body. With increasing numbers of osteoporotic compression fractures of the thoracic and lumbar spine, it is felt that 1 in 3 women and 1 in 5 men will have an osteoporotic fracture in their lifetime. By 2020, osteoporosis is expected to affect approximately 14 million people in the United States. These fractures become more common obviously in older population and current treatment recommendations include vertebroplasty which can be done as an outpatient and kyphoplasty, which requires an in hospital stay of approximately one day.

[0002] PMMA, poly methacrylate, is the substance used in both vertebroplasty and kyphoplasty. This material has been used throughout orthopedics for over 35 years. The first total hip replacements done by Dr. Charnley in Boston utilized a methacrylate. This material is also known as bone cement and its modulus of elasticity is much higher than that of cancellous or cortical bone. When this material is placed into a vertebral body and is allowed to cure, it creates an exothermic reaction, which can sometimes deaden or destroy nociceptin fibers and once it is hardened, it provides rigid support of the vertebra. Unfortunately, the remaining part of the vertebra and the part in which the cement has been placed cannot grow new bone. The exothermic reaction, if it is close to the endplate, can cause avascular necrosis and result in endplate fracture and adjacent segment collapse. Some of the issues that are associated with the use of PMMA include, but are not limited to, cord compression from ectopic cement extending from the vertebral body into the spinal canal, extrusion of cement through the cartilaginous endplate into the disc, allergic reaction to PMMA, coagulopathy, PMMA getting into the basivertebral sinus resulting in pulmonary emboli and infection because of the foreign body. These are some of the related complications that can occur with vertebroplasty or kyphoplasty. Furthermore, what we have seen over the years is that the cement, which does decrease pain, also appears to cause adjacent segment fractures at a later date. Someas early as a few months and others within a few years. The reason for these compression fractures is: 1 ) underlying osteoporosis throughout the vertebral bodies.2) cement having a higher density than the cortical or cancellous bone and adjacent microfracturing, which may not have been detected at the time of the initial procedure involving the adjacent vertebra. In addition, compression fractures at TS or above are technically difficult due to the small pedicle and the parallel orientation of these pedicles. The thoracic spine is also very vulnerable in the event the cement is extruded, which could result in myelopathy or paresis or plegia.

[0003] It should be noted that this Background is not intended to be an aid in determining the scope of the claimed subject matter nor be viewed as limiting the claimed subject matter to implementations that solve any or all of the disadvantages or problems presented above. The discussion of any technology, documents, or references in this Background section should not be interpreted as an admission that the material described is prior art to any of the subject matter claimed herein.SUMMARY

[0004] In one implementation, an implant material for stabilizing a vertebral body comprises a plurality of fenestrated shells. In another implementation, an implant material for stabilizing a spinal disk comprises a plurality of fenestrated shells. The implant material in either case may further comprise a particulate filler material that may comprise particulate bone. Methods of implanting these materials into vertebral bodies and / or spinal disks are also provided.

[0005] It is understood that various configurations of the subject technology will become apparent to those skilled in the art from the disclosure, wherein various configurations of the subject technology are shown and described by way of illustration. As will be realized, the subject technology is capable of other and different configurations and its several details are capable of modification in various other respects, all without departing from the scope of the subject technology. Accordingly, the summary, drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] Various embodiments are discussed in detail in conjunction with the Figures described below, with an emphasis on highlighting the advantageous features. Theseembodiments are for illustrative purposes only and any scale that may be illustrated therein does not limit the scope of the technology disclosed. These drawings include the following figures, in which like numerals indicate like parts.

[0007] FIG. 1 shows illustrates a vertebral body with a compression fracture;

[0008] FIG. 2 is a schematic block diagram of one implementation of a system for injecting implant material into a vertebral body in accordance with some example embodiments;

[0009] FIG. 3A, 3B, and 3B show different examples of fenestrated shells suitable as a component of a vertebral implant;

[0010] FIG. 4A is a schematic diagram of an example fenestrated shells suitable as a component of a vertebral implant material;

[0011] FIG. 4B is a schematic diagram of particulate material suitable as a component of a vertebral implant material;

[0012] FIG. 4G is a schematic diagram of a vertebral implant material comprising both the fenestrated shells of FIG. 4A and the particulate material of FIG. 4B;

[0013] FIG. 5 is a schematic diagram of fenestrated shells strung together along a filament;

[0014] FIGs. 6A and 6B illustrate an embodiment of a cartridge holding implant material for placement inside a vertebral body;

[0015] FIG. 7 illustrates a system for injecting implant material into a vertebral body.DETAILED DESCRIPTION

[0016] The following description and examples illustrate some exemplary implementations, embodiments, and arrangements of the disclosed invention in detail. Those of skill in the art will recognize that there are numerous variations and modifications of this invention that are encompassed by its scope. Accordingly, the description of a certain example embodiment should not be deemed to limit the scope of the present invention.

[0017] Referring now to FIG. 2, one exemplary apparatus of vertebral body stabilization will be described. The system of FIG. 2 includes a cannula 22 and a catheter 23 having a proximal end 23a. The cannula 22 is configured for accessing the interior portion of a human vertebral body. The cannula 22 may have an inner diameter in the range of 2.5 to 5 mm, 8 or 10-gauge rigid tubing for example, which is in the range used in conventionalvertebroplasty and kyphoplasty procedures. FIG. 2 shows the cannula 22 installed through a transpedicular opening into the interior portion 26 of a vertebral body 25. This is a common location for cannula insertion in currently performed vertebroplasty and kyphoplasty procedures, although a more lateral approach is sometimes utilized. It is also conceived that such a cannula can be inserted through the cartilaginous endplate into the vertebral body.

[0018] The catheter 23 is configured to be inserted into the central portion 26 of the vertebral body 25 through the cannula 22 and FIG. 2 illustrates the catheter 23 so positioned. The term catheter as used herein means any form of tube, rigid or flexible, made of any suitable material, whether polymer or metal or both. The system of FIG. 2 also includes a reservoir of implant material 24. The implant material 24 may contain fenestrated shells to be implanted into the inner portion 26 of the vertebral body as described in more detail below. An injector 28 may be coupled to the reservoir 24 of implant material and catheter 23 to force at least some of the implant material down the catheter and into the interior portion 26 of the vertebral body 25. In use, the components of FIG. 2 including the cannula 22, catheter 23, reservoir of implant material 24 and injector 28 may be provided to a physician as part or all of a surgical kit. In such a kit, the reservoir of implant material could be made part of the catheter 23 or the injector 28 and be pre-filled with implant material.

[0019] FIGs. 3A, 3B, and 30 illustrate fenestrated shells 32a, 32b, and 32c that may form all of or one component of an implant material suitable for implantation into a vertebral body. The different examples illustrate different sizes and locations of fenestrations and shell thicknesses. A wide variety of fenestration sizes, shell sizes, and shell thicknesses are suitable. The shells may have an aspect ratio between 1 :1 to 2:1 with a longest diameter of 5 mm or less and a smallest diameter of 0.2 mm or more. Aspect ratios greater than 2:1 are also possible although approximately spherical shells are advantageous in many embodiments.

[0020] The pattern of shell material and fenestrations may vary widely. In the example shell 32a of FIG. 3A, the shell itself is formed by three orthogonal great circle bands of a sphere, creating eight fenestrations arranged in a pattern analogous to the corners of a cube. In the example shell 32c of FIG. 3C, there are six fenestrations, arranged in a patternlike the faces of a cube. The shells may be rounded or have more pronounced corners such as shown in the example 32b of FIG. 3B.

[0021] The shells may be made from a variety of materials with metal being advantageous. For example, titanium and titanium alloys are advantageous in many embodiments. Stainless steel, cobalt chrome, and molybdenum and alloys thereof with or without titanium are also possible. Polymer materials like PLLA, PGA, PMMA can be used as well. The shells can be made with sintering techniques, material deposition onto spherical substrates (which can later be removed or remain wholly or partly in place) may be used to manufacture the shells. The shells may also be manufactured with additive manufacturing technologies, e.g. 3D printing of metal or polymer into the shell configurations. In some embodiments the shells can be formed from a hydrogel material.

[0022] FIG. 4A is a graphical representation of a fenestrated shell 32d such as those also shown in FIG. 3A, 3B, and 3C. As shown in FIG. 4A, the shell 32d comprises solid shell portions 33 and fenestrations 35 therethrough. The solid shell portions 33 define an interior region 37 of the fenestrated shell. The shell construction is preferably such that if an imaginary outer surface 39a around the outer contour of the body of the shell 32d (without entering the fenestrations) is considered, the content enclosed within that outer surface 39a is less than 90% solid shell material by volume. In some advantageous embodiments, the content enclosed within the surface 39a is less than 75% solid shell material by volume. In some advantageous embodiments, the content within the volume enclosed by that surface 39a is less than 50% solid shell material by volume. In some advantageous embodiments, the content within the volume enclosed by that surface 39a is less than 25% solid shell material by volume.

[0023] The interior region 37 may be defined to be a volume devoid of solid shell material within a second imaginary surface 38 that closely follows the interior contour of the shell 32d (without exiting the fenestrations). As a second independent characteristic of the shell 32d in addition to or as an alternative to the solid shell material content characteristic within surface 39a described above, in some advantageous embodiments this interior region 37 may be at least 10% of the volume enclosed by the outer surface 39a. In some advantageous embodiments, this interior region 37 may be at least 25% of the volume enclosed by the outer surface 39a. In some advantageous embodiments, this interior region 37 may be at least 50% of the volume enclosed by the outer surface 39a. In someadvantageous embodiments, this interior region 37 may be at least 75% of the volume enclosed by the outer surface 39a.

[0024] Some advantageous embodiments combine aspects of both of these characteristics due to the advantageous “shell” nature of the shell 32d. For example, in some advantageous embodiments, the solid shell content within the outer surface 39a is less than 90% by volume, and the volume of the interior region 37 is at least 10% of the volume enclosed by outer surface 39a. In other advantageous embodiments, the metal content within the outer surface 39a is less than 75% by volume, and the volume enclosed by interior region 37 is at least 25% of the volume enclosed by outer surface 39a. In some embodiments, depending on the thickness of the shell and the number and size of fenestrations, the metal content inside the volume enclosed by the outer surface 39a may be between 10% and 90% by volume and the volume of the interior region 37 may be between 10% and 90% of the volume of the region contained by outer surface 39a. In some embodiments, the metal content inside the volume enclosed by the outer surface 39a may be between 10% and 75% by volume and the volume of the interior region 37 may be between 25% and 90% of the volume of the region contained by outer surface 39a.

[0025] FIG. 4B is a graphical representation of a filler material 42 that may comprise a second component of an implant material along with the fenestrated shells 32d. In some embodiments, the filler material 42 comprises cortical and / or cancellous allograft bone particulates. However, metal or polymer particulates may also be used. Mixtures of bone, metal, and / or polymer in any relative ratio may be used. Materials such as Ti particles, collagen particles, PMMA, PEEK, PGA, hydrogel beads, and the like may be used as part or all of the filler material 42.

[0026] Referring now to FIG. 4G, an implant material may comprise a mixture of fenestrated shells 32d and filler material 42. The particles of the filler material may have aspect ratio of between 1 :1 and 1 :5 to one with larger diameter of 0.01 to 0.2 times the larger diameter of the shells of the implant. Generally, the particles of the filler material 42 may be small enough to enter the interior region 37 of the shells to impregnate the shells with filler material 42. Some filler material 42 may also remain outside the shells 32d as well. The combination filler material illustrated in FIG. 4G can be made by combining the fenestrated shells and particle filler 42 into a common container and mixing / agitating the combination to incorporate filler material into the interior regions 37 of the fenestrated shells.When the filler material comprises particulate bone, after the implant material is placed into a vertebral body, bone growth and fusion may occur through the particulate bone 42 as the fenestrated shells 32d provide solid structural support to the vertebral body. The shells 32d of the implant may all be made from the same material, or they may be made from different materials. For example, some of the shells may be metal and some may be polymer.

[0027] As a bulk implant material comprising a mixture of a plurality of shells 32d with filler material 42 (e.g. the material within imaginary surface 39b of FIG. 4C) the content of the bulk material is advantageously between 5% and 90% solid shell by volume. In some embodiments, it is between 10% and 75% solid shell by volume. In some embodiments, it is between 10% and 50% solid shell by volume. In some embodiments, it is between 10% and 25% solid shell by volume.

[0028] A variety of materials and therapeutics can be included as part of the filler material 42. These include growth factors, BMPs, antibiotics, opiates, chemotherapy sensors for detecting bone density or impending fracture, stem cells, PRP, gene therapy tools, drug eluting technology, etc. Also, the shell material 33 could be impregnated with HA or other materials to promote bone growth.

[0029] FIG. 5 illustrates a series of fenestrated shells 32d strung together on a filament which may be a titanium wire or other biocompatible material. This filament could help keep the shells 32d from migrating after implantation. Although not shown in FIG. 5, filler material 42 may also be used in conjunction with the connected shells 32d of FIG. 5.

[0030] Referring now to FIG. 6A, a system / kit for stabilization of vertebral bodies may include a cartridge 60. The cartridge 60 may include an internal shaft 61 with one or more lumens or barrels containing the implant material as described in this disclosure. Different lumens or barrels may be selectively aligned with an outlet needle 63. As shown in FIG. 6B, the outlet needle could be loaded from the barrels with a series of fenestrated shells 32d filled with particulate filler 42 for injection to the internal space of a vertebral body. The filament of FIG. 5 could be strung through the shells of FIG. 6B in some embodiments.

[0031] A surgical kit may thus include one or more cartridges 60 each with one or more lumens or barrels sized to accept the implant material described above. In some embodiments, the kit may include one or more cartridges 60 pre-loaded with implantmaterial. Each cartridge 60 may be removably attached to an injector device configured to push implant material out of the cartridge(s) 60.

[0032] Referring now to FIG. 7, an example apparatus and system for performing such a procedure is illustrated. In FIG. 7, a cartridge 72 has a plunger 73 that can be used to push implant material out of the distal end of the injector which may be installed through the pedicle in a manner similar to the injectors described above. A kyphoplasty balloon may be used to create or enlarge a cavity 74 inside the vertebral body to receive the implant material. The implant material may be pushed down a cylindrical lumen in the injection needle using the plunger 73. The lumen diameter may be slightly larger than the diameter of the fenestrated shells 32d. The procedure may be performed via single or dual portal, where one of the portals could be used for suction, visualization with an endoscopic camera, or introduction of a kyphoplasty balloon.

[0033] To help prevent post injection migration of the shells 32d, the filament 54 of FIG. 5 may be employed. Alternatively or additionally, a surrounding mesh could be deployed in the cavity 74 prior to injecting the implant material. Also, the fenestrated shells 32d may be magnetized so that they tend to stick together in a ball after implantation.

[0034] The implant material described herein may be used in other applications besides vertebral bodies. It may be used to fill any bone defect whether due to a cyst, fracture, tumor, or any other cause. Such defects treatable with the above-described implant include long bones, flat bones, or pelvis for example. The implant material described herein may also have application in stabilizing spinal disks between vertebra, where the material may be injected into the nucleus of a weakened spinal disk. A similar application may be injecting the implant material described herein into the nucleus of spinal disks above and / or below the location of a fusion procedure, thus stabilizing the adjacent levels.General Interpretive Principles for the Present Disclosure

[0035] Various aspects of the novel systems, apparatuses, and methods are described more fully hereinafter with reference to the accompanying drawings. The teachings disclosure may, however, be embodied in many different forms and should not be construed as limited to any specific structure or function presented throughout this disclosure. Rather, these aspects are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. Based on the teachingsherein one skilled in the art should appreciate that the scope of the disclosure is intended to cover any aspect of the novel systems, apparatuses, and methods disclosed herein, whether implemented independently of or combined with any other aspect of the disclosure. For example, a system or an apparatus may be implemented, or a method may be practiced using any one or more of the aspects set forth herein. In addition, the scope of the disclosure is intended to cover such a system, apparatus or method which is practiced using other structure, functionality, or structure and functionality in addition to or other than the various aspects of the disclosure set forth herein. It should be understood that any aspect disclosed herein may be set forth in one or more elements of a claim. Although some benefits and advantages of the preferred aspects are mentioned, the scope of the disclosure is not intended to be limited to particular benefits, uses, or objectives. The detailed description and drawings are merely illustrative of the disclosure rather than limiting, the scope of the disclosure being defined by the appended claims and equivalents thereof.

[0036] With respect to the use of plural vs. singular terms herein, those having skill in the art can translate from the plural to the singular and / or from the singular to the plural as is appropriate to the context and / or application. The various singular / plural permutations may be expressly set forth herein for sake of clarity.

[0037] When describing an absolute value of a characteristic or property of a thing or act described herein, the terms “substantial,” “substantially,” “essentially,” “approximately,” and / or other terms or phrases of degree may be used without the specific recitation of a numerical range. When applied to a characteristic or property of a thing or act described herein, these terms refer to a range of the characteristic or property that is consistent with providing a desired function associated with that characteristic or property.

[0038] In those cases where a single numerical value is given for a characteristic or property, it is intended to be interpreted as at least covering deviations of that value within one significant digit of the numerical value given.

[0039] If a numerical value or range of numerical values is provided to define a characteristic or property of a thing or act described herein, whether or not the value or range is qualified with a term of degree, a specific method of measuring the characteristic or property may be defined herein as well. In the event no specific method of measuring the characteristic or property is defined herein, and there are different generally acceptedmethods of measurement for the characteristic or property, then the measurement method should be interpreted as the method of measurement that would most likely be adopted by one of ordinary skill in the art given the description and context of the characteristic or property. In the further event there is more than one method of measurement that is equally likely to be adopted by one of ordinary skill in the art to measure the characteristic or property, the value or range of values should be interpreted as being met regardless of which method of measurement is chosen.

[0040] It will be understood by those within the art that terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are intended as “open” terms unless specifically indicated otherwise (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.).

[0041] It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases “at least one” and “one or more” to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles “a” or “an” limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an” (e.g., “a” and / or “an” should typically be interpreted to mean “at least one” or “one or more”); the same holds true for the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of “two recitations,” without other modifiers, typically means at least two recitations, or two or more recitations).

[0042] In those instances where a convention analogous to “at least one of A, B, and C” is used, such a construction would include systems that have A alone, B alone, C alone, A and B together without C, A and C together without B, B and C together without A, as well as A, B, and C together. It will be further understood by those within the art that virtuallyany disjunctive word and / or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include A without B, B without A, as well as A and B together.”

[0043] Various modifications to the implementations described in this disclosure can be readily apparent to those skilled in the art, and generic principles defined herein can be applied to other implementations without departing from the spirit or scope of this disclosure. Thus, the disclosure is not intended to be limited to the implementations shown herein but is to be accorded the widest scope consistent with the claims, the principles and the novel features disclosed herein. The word “exemplary” is used exclusively herein to mean “serving as an example, instance, or illustration.” Any implementation described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other implementations.

[0044] Certain features that are described in this specification in the context of separate implementations also can be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation also can be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features can be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination can be directed to a sub-combination or variation of a sub-combination.

[0045] The methods disclosed herein comprise one or more steps or actions for achieving the described method. The method steps and / or actions may be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is specified, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the claims.

Claims

WHAT IS CLAIMED IS:1 . An implant material for use in stabilizing a vertebral body, wherein the implant material comprises a plurality of fenestrated shells.

2. The implant material of claim 1 , wherein each of the plurality of fenestrated shells defines an interior region, and wherein the interior region of at least some of the plurality of shells comprises bone.

3. The implant material of claim 1 , wherein each of the plurality of fenestrated shells defines an interior region, and wherein the interior region of at least some of the plurality of shells comprises a particulate material.

4. The implant material of claim 3, wherein the particulate material comprises bone particles.

5. The implant material of claim 3, wherein the particulate material comprises polymer particles.

6. The implant material of any one of claims 1 to 5, wherein at least some of the plurality of fenestrated shells comprise metal.

7. The implant material of any one of claims 1 to 5, wherein at least some of the plurality of fenestrated shells comprise polymer.

8. The implant material of any preceding claim, wherein the implant material comprises bone morphogenic protein.

9. The implant material of any preceding claim, wherein at least some of the plurality of fenestrated shells comprises an interior volume devoid of solid shell material.

10. The implant material of claim 10, wherein within the outer surface of the at least some of the plurality of fenestrated shells is less than 90% solid shell material by volume.11 .The implant material of claim 10, wherein within the outer surface of the at least some of the plurality of fenestrated shells is less than 75% solid shell material by volume.

12. The implant material of claim 10, wherein within the outer surface of the at least some of the plurality of fenestrated shells is less than 50% solid shell material by volume.

13. The implant material of claim 10, wherein within the outer surface of the at least some of the plurality of fenestrated shells is less than 25% solid shell material by volume.

14. The implant material of any one of claims 9 to 13, wherein the at least some of the plurality of fenestrated shells each have a largest diameter of 5 mm or less.

15. The implant material of claim 14, wherein the at least some of the plurality of fenestrated shells each have a smallest diameter of 0.2 mm or less.

16. The implant material of any one of claims 1 to 8, wherein at least some of the plurality of fenestrated shells each have a largest diameter of 5 mm or less.

17. The implant material of claim 16, wherein at least some of the plurality of fenestrated shells each have a smallest diameter of 0.2 mm or less.

18. The implant material of any preceding claim, wherein the implant material comprises titanium particles.

19. The implant material of any preceding claim, wherein the implant material comprises collagen particles.

20. The implant material of any preceding claim, wherein the implant material comprises hydrogel beads.21 .The implant material of any preceding claim, wherein at least some of the plurality of fenestrated shells are strung along a filament.

22. An implant material for use in stabilizing a spinal disk, wherein the implant material comprises a plurality of fenestrated shells.

23. The implant material of claim 22, wherein each of the plurality of fenestrated shells defines an interior region, and wherein the interior region of at least some of the plurality of shells comprises bone.

24. The implant material of claim 22, wherein each of the plurality of fenestrated shells defines an interior region, and wherein the interior region of at least some of the plurality of shells comprises a particulate material.

25. The implant material of claim 24, wherein the particulate material comprises bone particles.

26. The implant material of claim 24, wherein the particulate material comprises polymer particles.

27. The implant material of any one of claims 22 to 26, wherein at least some of the plurality of fenestrated shells comprise metal.

28. The implant material of any one of claims 22 to 26, wherein at least some of the plurality of fenestrated shells comprise polymer.

29. The implant material of any one of claims 22 to 28, wherein the implant material comprises bone morphogenic protein.

30. The implant material of any one of claims 22 to 29, wherein at least some of the plurality of fenestrated shells comprises an interior volume devoid of solid shell material.31 .The implant material of claim 30, wherein within the outer surface of the at least some of the plurality of fenestrated shells is less than 90% solid shell material by volume.

32. The implant material of claim 30, wherein within the outer surface of the at least some of the plurality of fenestrated shells is less than 75% solid shell material by volume.

33. The implant material of claim 30, wherein within the outer surface of the at least some of the plurality of fenestrated shells is less than 50% solid shell material by volume.

34. The implant material of claim 30, wherein within the outer surface of the at least some of the plurality of fenestrated shells is less than 25% solid shell material by volume.

35. The implant material of any one of claims 30 to 34, wherein the at least some of the plurality of fenestrated shells each have a largest diameter of 5 mm or less.

36. The implant material of claim 35, wherein the at least some of the plurality of fenestrated shells each have a smallest diameter of 0.2 mm or less.

37. The implant material of any one of claims 22 to 29, wherein at least some of the plurality of fenestrated shells each have a largest diameter of 5 mm or less.

38. The implant material of claim 37, wherein at least some of the plurality of fenestrated shells each have a smallest diameter of 0.2 mm or less.

39. The implant material of any one of claims 22 to 38, wherein the implant material comprises titanium particles.

40. The implant material of any one of claims 22 to 39, wherein the implant material comprises collagen particles.41 .The implant material of any one of claims 22 to 40, wherein the implant material comprises hydrogel beads.

42. The implant material of any one of claims 22 to 41 , wherein at least some of the plurality of fenestrated shells are strung along a filament.

43. A method of stabilizing a vertebral body comprising: accessing an interior portion of the vertebral body; and placing the implant material of any one of claims 1 to 21 into the interior portion of the vertebral body.

44. A method of stabilizing a spinal disk comprising: accessing an interior portion of the spinal disk; andplacing the implant material of any one of claims 21 to 42 into the interior portion of the spinal disk.

45. A method of stabilizing a vertebral body comprising: accessing an interior portion of the vertebral body; and placing the implant material comprising a plurality of fenestrated shells into the interior portion of the vertebral body.

46. The method of claim 45, wherein each of the plurality of fenestrated shells defines an interior region, and wherein the interior region of at least some of the plurality of shells comprises bone.

47. The method of claim 45, wherein each of the plurality of fenestrated shells defines an interior region, and wherein the interior region of at least some of the plurality of shells comprises a particulate material.

48. The method of claim 47, wherein the particulate material comprises bone particles.

49. The method of claim 47, wherein the particulate material comprises polymer particles.

50. The method of claim 45, wherein at least some of the plurality of fenestrated shells comprise metal.

51. The method of claim 45, wherein at least some of the plurality of fenestrated shells comprise polymer.

52. The method of claim 45, wherein the implant material comprises bone morphogenic protein.

53. The method of claim 45, wherein at least some of the plurality of fenestrated shells comprises an interior volume devoid of solid shell material.

54. The method of claim 53, wherein within the outer surface of the at least some of the plurality of fenestrated shells is less than 90% solid shell material by volume.

55. The method of claim 53, wherein within the outer surface of the at least some of the plurality of fenestrated shells is less than 75% solid shell material by volume.

56. The method of claim 53, wherein within the outer surface of the at least some of the plurality of fenestrated shells is less than 50% solid shell material by volume.

57. The method of claim 53, wherein within the outer surface of the at least some of the plurality of fenestrated shells is less than 25% solid shell material by volume.

58. The method of claim 45, wherein at least some of the plurality of fenestrated shells each have a largest diameter of 5 mm or less.

59. The method of claim 58, wherein at least some of the plurality of fenestrated shells each have a smallest diameter of 0.2 mm or less.

60. The method of claim 45, wherein the implant material comprises titanium particles.

61. The method of claim 45, wherein the implant material comprises collagen particles.

62. The method of claim 45, wherein the implant material comprises hydrogel beads.

63. The method of claim 45, wherein at least some of the plurality of fenestrated shells are strung along a filament.

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