Biocompatible granule structures

Biocompatible granule structures with specific surface features and cannulated designs address the shortcomings of conventional materials in surgical applications, enhancing interlocking and bony ingrowth while preventing migration.

WO2025117313A1PCT designated stage expired Publication Date: 2025-06-05KYOCERA MEDICAL TECHNOLOGIES INC
View PDF 5 Cites 0 Cited by

Patent Information

Application Number
PCT/US2024/056832
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-11-27
Filing Date
2024-11-21
Publication Date
2025-06-05

AI Technical Summary

Technical Problem

Conventional materials used in surgical applications such as kyphoplasty and vertebroplasty suffer from issues like migration, inadequate interlocking behavior, and insufficient bony ingrowth and purchase.

Method used

Biocompatible granule structures made of bony substance or biocompatible metallic, ceramic, or polymeric materials, which are 3D printed and feature gross and surface features for interlocking and bony purchase, and are cannulated to prevent migration by being strung together like beads on a chain.

Benefits of technology

The biocompatible granule structures effectively prevent migration, promote interlocking and bony ingrowth, and enhance healing in bone structures by providing a stable and interconnected network within the bone voids.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure 00000021_0000
    Figure 00000021_0000
  • Figure 00000022_0000
    Figure 00000022_0000
  • Figure 00000023_0000
    Figure 00000023_0000
Patent Text Reader

Abstract

The present disclosure provides biocompatible granule structures and associated assemblies and methods. These biocompatible granule structures are introduced into a void or space in a bone structure or between bone structures disposed on a flexible elongate structure to partially fill the volume and promote bony ingrowth and healing in a variety of surgical applications, such as kyphoplasty and vertebroplasty procedures and the like. The biocompatible granule structures are made of a bony substance or a biocompatible metallic, ceramic, or polymeric material and provide superior migration, interlocking behavior, and bony purchase and ingrowth properties.
Need to check novelty before this filing date? Find Prior Art

Description

BIOCOMPATIBLE GRANULE STRUCTURESCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present disclosure claims the benefit of priority of co-pending U.S. Provisional Patent Application No. 63 / 602,837, filed on November 27, 2023, and entitled “BIOCOMPATIBLE GRANULE STRUCTURES,” the contents of which are incorporated in full by reference.TECHNICAL FIELD

[0002] The present disclosure relates generally to the medical and surgical fields. More particularly, the present disclosure relates to biocompatible granule structures and associated assemblies and methods. These biocompatible granule structures are introduced into a void or space in a bone structure or between bone structures to partially fill the volume and promote bony ingrowth and healing in a variety of surgical applications, such as kyphoplasty and vertebroplasty procedures and the like.BACKGROUND

[0003] In a variety of surgical applications, such as kyphoplasty and vertebroplasty procedures and the like, it is desirable to introduce material into a void or space in a bone structure or between bone structures to partially fill the volume and promote bony ingrowth and healing. Conventionally, this has been accomplished using a paste material, a single implant, or a plurality of beads or the like in a slurry, for example. Such materials may be made of a bony substance or a biocompatible metallic, ceramic, or polymericmaterial. These conventional materials suffer from a number of shortcomings, including migration, inadequate interlocking behavior and inadequate bony purchase and ingrowth.

[0004] The present background is provided as illustrative environmental context only and should not be construed to be limiting in any manner. It will be readily apparent to those of ordinary skill in the art that the structures, assemblies, and methods of the present disclosure may be used in analogous environmental contexts and applications without limitation.SUMMARY

[0005] The present disclosure provides biocompatible granule structures and associated assemblies and methods. These biocompatible granule structures are introduced into a void or space in a bone structure or between bone structures to partially fill the volume and promote bony ingrowth and healing in a variety of surgical applications, such as kyphoplasty and vertebroplasty procedures and the like. The biocompatible granule structures are made of a bony substance or a biocompatible metallic, ceramic, or polymeric material and provide superior migration, interlocking behavior, and bony purchase and ingrowth properties.

[0006] In some embodiments, the biocompatible granule structures are 3D printed and have diameters or defining dimensions on the order of 2.5-3 mm or 4-5 mm, although other suitable manufacturing methodologies and dimensions may also be utilized.

[0007] In some embodiments, the biocompatible granule structures have gross and surface features (roughness) that promote interlocking and bony purchase and ingrowth.

[0008] In some embodiments, the biocompatible granule structures each have a hollow core with a surrounding truss or shell structure, have arms arranged along and / or emanating from a solid core and / or major and / or minor axis, or a solid core with a surrounding truss or shell structure. The biocompatible granule structures illustrated anddescribed are specific embodiments, which may be extended to other similar embodiments as desired.

[0009] In some embodiments, the biocompatible granule structures are cannulated, have hollow cores, and / or define internal passages through which a flexible elongated structure, such as a wire, string, suture, or the like, can be passed to couple adjacent biocompatible granule structures together, like beads on a chain. This prevents migration of the biocompatible granule structures and further promotes interlocking and bony purchase and ingrowth. The biocompatible granule structures disposed on a flexible elongated structure can all have the same size and configuration, sizes and / or configurations can alternate, or different sizes and / or configurations can be utilized. Again, this prevents migration of the biocompatible granule structures and further promotes interlocking and bony purchase and ingrowth.

[0010] A wide variety of biocompatible granule structure configurations are contemplated, but in various embodiments, the internal passages through which the flexible elongated structure is introduced may pass through the core or center of each of the biocompatible granule structures in a symmetric arrangement, may coincide with a major axis of each of the biocompatible granule structures, may coincide with a minor axis of each of the biocompatible granule structures, or may be offset from the core or center of each of the biocompatible granule structures in an asymmetric arrangement.

[0011] In some embodiments, the present disclosure provides a biocompatible granule structure including a body structure having an external dimension on the order of 1-10 mm, where the body structure defines one or more of an internal arm, internal struts, an internal truss structure, an external shell, an external truss structure, a plurality of lobes, a solid internal core, a hollow internal core, and / or a roughened external surface that promote interlocking of the biocompatible granule structure with an adjacent biocompatible granule structure and bony purchase and ingrowth when the biocompatible granule structures are introduced into a void or space in a bone structure or between bone structures to partially fill the volume in a surgical application. In some embodiments,the body structure is symmetric about one or more axes. In some embodiments, the body structure is asymmetric about one or more axes. In some embodiments, the body structure defines one or more channels running through the body structure and adapted to receive flexible elongate structure through the body structure. The channel is one of a straight tube, a circuitous conduit, or a plurality of interconnected internal voids and external openings of the body structure. In some embodiments, the channel runs through a core of the body structure. In some embodiments, the channel runs adjacent to a core of the body structure. In some embodiments, the channel runs along a major axis of the body structure. In some embodiments, the channel runs along a minor axis of the body structure. In some embodiments, the body structure is additively manufactured from one of a biocompatible metallic material, a biocompatible ceramic material, and a biocompatible polymeric material.

[0012] In some embodiments, the present disclosure provides a biocompatible granule assembly including a plurality of biocompatible granule structures each including a body structure having an external dimension on the order of 1 -10 mm, where the body structure defines one or more of an internal arm, internal struts, an internal truss structure, an external shell, an external truss structure, a plurality of lobes, a solid internal core, a hollow internal core, and / or a roughened external surface that promote interlocking of the biocompatible granule structure with an adjacent biocompatible granule structure and bony purchase and ingrowth when the biocompatible granule structures are introduced into a void or space in a bone structure or between bone structures to partially fill the volume in a surgical application, and where the body structure defines one or more channels running through the body structure, and a flexible elongate structure including one of a wire, a string, a thread, or a suture disposed through a channel of each of the plurality of biocompatible granule structures to hold the plurality of biocompatible granule structures adjacent to one another. In some embodiments, the body structure is symmetric about one or more axes. In some embodiments, the body structure is asymmetric about one or more axes. The channels are each one of a straight tube, a circuitous conduit, or a plurality of interconnected internal voids and external openings of the body structure. In some embodiments, at least some of the channels run through acore of at least some of the body structures. In some embodiments, at least some of the channels run adjacent to a core of at least some of the body structures. In some embodiments, at least some of the channels run along a major axis of at least some of the body structures. In some embodiments, at least some of the channels run along a minor axis of at least some of the body structures. In some embodiments, the body structure is additively manufactured from one of a biocompatible metallic material, a biocompatible ceramic material, and a biocompatible polymeric material.

[0013] In some embodiments, the present disclosure provides a method including additively manufacturing a plurality of biocompatible granule structures from one of a biocompatible metallic material, a biocompatible ceramic material, or a biocompatible polymeric material, and threading a flexible elongate structure including one of a wire, a string, a thread, or a suture through a channel manufactured into each of the plurality of granule structures to form a surgical implant assembly that is configured to be disposed in a void or space in a bone structure or between bone structures to partially fill a volume and promote bony ingrowth.

[0014] It will be readily apparent to those of ordinary skill in the art that features and aspects of each of the described embodiments of the present disclosure may be included, omitted, and / or combined as desired in a given application, without limitation.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The present disclosure is illustrated and described with reference to the following drawings, in which like reference numbers are used to denote like structure / assembly components / method steps, as appropriate, and in which:

[0016] FIG. 1 illustrates an embodiment of the biocompatible granule structure and associated assembly of the present disclosure;

[0017] FIG. 2 illustrates another embodiment of the biocompatible granule structure and associated assembly of the present disclosure;

[0018] FIG. 3 illustrates an embodiment of the method of the present disclosure;

[0019] FIG. 4 illustrates an embodiment of the biocompatible granule structure of the present disclosure;

[0020] FIG. 5 illustrates another embodiment of the biocompatible granule structure of the present disclosure;

[0021] FIG. 6 illustrates a further embodiment of the biocompatible granule structure of the present disclosure;

[0022] FIG. 7 illustrates a still further embodiment of the biocompatible granule structure of the present disclosure;

[0023] FIG. 8 illustrates a still further embodiment of the biocompatible granule structure of the present disclosure;

[0024] FIG. 9 illustrates a still further embodiment of the biocompatible granule structure of the present disclosure;

[0025] FIG. 10 illustrates a still further embodiment of the biocompatible granule structure of the present disclosure;

[0026] FIG. 11 illustrates a still further embodiment of the biocompatible granule structure of the present disclosure;

[0027] FIG. 12 illustrates a still further embodiment of the biocompatible granule structure of the present disclosure;

[0028] FIG. 13 illustrates still further embodiments of the biocompatible granule structure of the present disclosure;

[0029] FIG. 14 illustrates still further embodiments of the biocompatible granule structure of the present disclosure;

[0030] FIG. 15 illustrates still further embodiments of the biocompatible granule structure of the present disclosure;

[0031] FIG. 16 illustrates still further embodiments of the biocompatible granule structure of the present disclosure; and

[0032] FIG. 17 illustrates still further embodiments of the biocompatible granule structure of the present disclosure.

[0033] It will be readily apparent to those of ordinary skill in the art that features and aspects of each of the illustrated embodiments of the present disclosure may be included, omitted, and / or combined as desired in a given application, without limitation.DETAILED DESCRIPTION

[0034] Again, the present disclosure provides biocompatible granule structures and associated assemblies and methods. These biocompatible granule structures are introduced into a void or space in a bone structure or between bone structures to partially fill the volume and promote bony ingrowth and healing in a variety of surgical applications, such as kyphoplasty and vertebroplasty procedures and the like. The biocompatible granule structures are made of a bony substance or a biocompatible metallic, ceramic, or polymeric material and provide superior migration, interlocking behavior, and bony purchase and ingrowth properties.

[0035] In some embodiments, the biocompatible granule structures are 3D printed and have diameters or defining dimensions on the order of 2.5-3 mm or 4-5 mm, although other suitable manufacturing methodologies and dimensions may also be utilized.

[0036] In some embodiments, the biocompatible granule structures have gross and surface features (roughness) that promote interlocking and bony purchase and ingrowth.

[0037] In some embodiments, the biocompatible granule structures each have a hollow core with a surrounding truss or shell structure, have arms arranged along and / or emanating from a solid core and / or major and / or minor axis, or a solid core with a surrounding truss or shell structure. The biocompatible granule structures illustrated and described are specific embodiments, which may be extended to other similar embodiments as desired.

[0038] In some embodiments, the biocompatible granule structures are cannulated, have hollow cores, and / or define internal passages through which a flexible elongated structure, such as a wire, string, suture, or the like, can be passed to couple adjacent biocompatible granule structures together, like beads on a chain. This prevents migration of the biocompatible granule structures and further promotes interlocking and bony purchase and ingrowth. The biocompatible granule structures disposed on a flexible elongated structure can all have the same size and configuration, sizes and / or configurations can alternate, or different sizes and / or configurations can be utilized. Again, this prevents migration of the biocompatible granule structures and further promotes interlocking and bony purchase and ingrowth.

[0039] A wide variety of biocompatible granule structure configurations are contemplated, but in various embodiments, the internal passages through which the flexible elongated structure is introduced may pass through the core or center of each of the biocompatible granule structures in a symmetric arrangement, may coincide with a major axis of each of the biocompatible granule structures, may coincide with a minor axis of each of thebiocompatible granule structures, or may be offset from the core or center of each of the biocompatible granule structures in an asymmetric arrangement.

[0040] FIG. 1 illustrates an embodiment of the biocompatible granule structures 100 and associated assembly 200 of the present disclosure. Here, each of the granule structures 100 includes a roughly externally symmetric body structure 102, with a major axis that is comparable to any nominally minor axis. The body structure 102 may be substantially solid, substantially hollow, or encompass substantially solid and substantially hollow portions. The body structure 102 has an outside diameter of 1 -10 mm, for example. The body structure 102 may include any number and configuration of internal arm, strut, and / or truss structures 104, and may include any substantially solid or substantially open external shell or truss structure 106. Further, the body structure 102 may utilize a core 108 that is substantially solid or substantially hollow. Thus, in the simplest example, the granule structure is a substantially solid circular bead, while a multitude of complex external shapes and external and internal configurations are possible.

[0041] Regardless of the external shape and external and internal configuration, the body structure 102 defines at least one channel 110 that passes through the body structure 102 and is configured to pass a flexible elongate structure 112 through the body structure 102. This channel 110 may be a straight tube, a circuitous conduit, or may consist of a plurality of interconnected internal voids and external openings of the body structure 102. As illustrated, the channel 110 may run through the core 108 of the body structure 102, or the channel 110 may be offset from the core 108 of the body structure 102.

[0042] The flexible elongate structure 112 is a wire, string, suture, or the like that is biocompatible on which a plurality of adjacent granule structures 100 are strung to form a biocompatible granule assembly 200 that is introduced into a void or space in a bone structure or between bone structures to partially fill the volume and promote bony ingrowth and healing in a variety of surgical applications. The granule structures 100 are made of a bony substance or a biocompatible metallic, ceramic, or polymeric materialand provide superior migration, interlocking behavior, and bony purchase and ingrowth properties.

[0043] Again, the granule structures 100 may be 3D printed and have diameters or defining dimensions on the order of 2.5-3 mm or 4-5 mm, although other suitable manufacturing methodologies and dimensions may also be utilized. The granule structures 100 may have gross and surface features (roughness) that promote interlocking and bony purchase and ingrowth. Such surface roughness may be imparted to the internal arm, strut, and / or truss structures 104, as well as any substantially solid or substantially open external shell or truss structure 106.

[0044] Because the granule structures 100 are strung together like beads on a chain, the granule structures 100 will fill the void in which they are disposed, interlock with one another, and provide a complex network of small spaces for bony ingrowth, all while being prevented from migrating by the flexible elongate structure 112, which serves as a convenient means for inserting the granule structures 100 into the void and manipulating the granule structures 100 within the void. The granule structures 100 disposed on the flexible elongated structure 112 can all have the same size and configuration, sizes and / or configurations can alternate, or different sizes and / or configurations can be utilized. The channel 110 utilized for each granule structure 100 can also be alternated or varied to provide an offset from granule-to-granule along the flexible elongate structure 112. Again, this prevents migration of the biocompatible granule structures and further promotes interlocking and bony purchase and ingrowth.

[0045] FIG. 2 illustrates another embodiment of the biocompatible granule structures 100 and associated assembly 200 of the present disclosure. Here, each of the granule structures 100 includes an externally asymmetric body structure 102, with a major axis that differs from a minor axis. The body structure 102 may again be substantially solid, substantially hollow, or encompass substantially solid and substantially hollow portions. The body structure 102 has an outside dimensions of 1 -10 mm, for example. The body structure 102 may include any number and configuration of internal arm, strut, and / ortruss structures 104, as in FIG. 1 , and may include any substantially solid or substantially open external shell or truss structure 106, as in FIG. 1. Further, the body structure 102 may utilize a core 108 that is substantially solid or substantially hollow, as in FIG. 1 . Thus, in the simplest example, the granule structure is a substantially solid cylinder or pill, while a multitude of complex external shapes and external and internal configurations are possible.

[0046] Regardless of the external shape and external and internal configuration, the body structure 102 defines at least one channel 110 that passes through the body structure 102 and is configured to pass the flexible elongate structure 112 through the body structure 102. In other words, the channel 110 may be located to have two or more independent openings in the body structure 102. This channel 110 may be a straight tube, a circuitous conduit, or may consist of a plurality of interconnected internal voids and external openings of the body structure 102. As illustrated, the channel 110 may run through the core 108 of the body structure 102, along, parallel, or at an angle to the major axis, or the channel 110 may be offset from the core 108 of the body structure 102, along, parallel, or at an angle to the minor axis. In such embodiments, the channel 110 may not pass wholly through the body structure 102. Rather, the channel 110 may be a recess formed in an exterior of the body structure 102. This recess may have at least one portion that is narrowed, such as the exterior portion at the exterior surface of the body structure 102. That is, the recess may have at least one constricted portion. The width of the constricted portion may be small as compared to the thickness of the flexible elongated structure 112. This allows the biocompatible granule assembly 200 to be formed without the biocompatible granule structure 100 disengaging from the flexible elongate structure 112 even though the channel 110 does not pass wholly through the body structure 102, i.e. , the channel 110 is not entirely encompassed within the body structure 102. FIG. 12 provides an example of such a structural configuration.

[0047] The flexible elongate structure 112 is again a wire, string, suture, or the like that is biocompatible on which a plurality of adjacent granule structures 100 are strung to form a biocompatible granule assembly 200 that is introduced into a void or space in a bonestructure or between bone structures to partially fill the volume and promote bony ingrowth and healing in a variety of surgical applications. The granule structures 100 are made of a bony substance or a biocompatible metallic, ceramic, or polymeric material and provide superior migration, interlocking behavior, and bony purchase and ingrowth properties.

[0048] Again, the granule structures 100 may be 3D printed and have diameters or defining dimensions on the order of 2.5-3 mm or 4-5 mm, although other suitable manufacturing methodologies and dimensions may also be utilized. The granule structures 100 may have gross and surface features (roughness) that promote interlocking and bony purchase and ingrowth. Such surface roughness may be imparted to the internal arm, strut, and / or truss structures 104, as well as any substantially solid or substantially open external shell or truss structure 106.

[0049] Because the granule structures 100 are strung together like beads on a chain, the granule structures 100 will fill the void in which they are disposed, interlock with one another, and provide a complex network of small spaces for bony ingrowth, all while being prevented from migrating by the flexible elongate structure 112, which serves as a convenient means for inserting the granule structures 100 into the void and manipulating the granule structures 100 within the void. The granule structures 100 disposed on the flexible elongated structure 112 can all have the same size and configuration, sizes and / or configurations can alternate, or different sizes and / or configurations can be utilized. The channel 110 utilized for each granule structure 100 can also be alternated or varied to provide an offset from granule-to-granule along the flexible elongate structure 112 or vary the major axis / minor axis orientation from granule-to-granule along the flexible elongate structure 112. Again, this prevents migration of the biocompatible granule structures and further promotes interlocking and bony purchase and ingrowth.

[0050] FIG. 3 illustrates an embodiment of the method 300 of the present disclosure. The method 300 first includes additively manufacturing a plurality of biocompatible granule structures from a metallic, ceramic, or polymeric material (step 302). The method300 second includes threading a flexible elongate structure through a channel manufactured into each of the plurality of granule structures to form a surgical implant assembly (step 304). The method 300 third includes disposing the surgical implant assembly in a void or space in a bone structure or between bone structures to partially fill the volume and promote bony ingrowth and healing (step 306). It should be noted that the surgical implant assembly may be surround by a substance that enhances void filling and / or bony ingrowth and healing.

[0051] FIG. 4 is a primarily spherical granule structure with porosity provided by holes disposed within and through the outer surface of the granule structure. Voids are also provided between the granule structures.

[0052] FIG. 5 is a primarily spherical / dodecagon granule structure with porosity provided by holes disposed within and through the outer surface of the granule structure, provided by a truss structure. Voids are also provided between the granule structures. Nobs are provided on the outer surface of the granule structure. The shape provided promotes stacking and the interlocking of the granule structures.

[0053] FIG. 6 is a primarily spherical / dodecagon granule structure with porosity provided by holes disposed within and through the outer surface of the granule structure. Voids are also provided between the granule structures. Nobs are provided on the outer surface of the granule structure. The shape provided promotes stacking and the interlocking of the granule structures. An internal lattice is left out for smaller versions of this embodiment and it may be customized to fit the pore sizes needed for angiogenesis.

[0054] FIG. 7 is a primarily cylindrical / helical granule structure with random porosity provided by holes disposed within and through the outer surface of the granule structure and the interaction of parts of adjacent granule structures. Voids are thus provided between the granule structures. The shape provided promotes stacking and the interlocking of the granule structures. An internal void is absent.

[0055] FIG. 8 is a primarily cylindrical granule structure with random porosity provided by holes disposed within and through the outer surface of the granule structure and the interaction of arms of adjacent granule structures. Voids are thus provided between the granule structures. The shape provided promotes stacking and the interlocking of the granule structures. An internal void is absent. The design promotes fusion of the parts’ crowns due to the metal fusing, which may be beneficial.

[0056] FIG. 9 is a primarily short cylinder granule structure with porosity focused on protrusions of the structure interacting with other structures as the outside features create distance and voids between the part and the next part. There is a central hole. Porosity is more random because of the cylindrical design.

[0057] FIG. 10 is a primarily short cylinder granule structure with porosity focused on protrusions of the structure interacting with other structures as the outside features create distance and voids between the part and the next part. There is a central hole. Porosity is more random because of the cylindrical design.

[0058] FIG. 11 is a primarily cylinder or dumbbell granule structure with porosity focused on the structure interacting with other structures. There are no holes. The pores are formed from interactions of the part with other parts. The lack of holes provides a strong tendency to stack. Different granule sizes may be used to promote better stacking.

[0059] FIG. 12 is a primarily spherical granule structure with porosity provided by arms protruding from a central point and outer partial shell structures provided. Voids are also provided between the granule structures.

[0060] FIG. 13 is primarily spherical granule structures with porosity provided by various truss structures and optionally outer partial shell structures provided. Voids are also provided between the granule structures.

[0061] FIG. 14 is primarily spherical and planar granule structures with porosity provided by various truss and arm structures and optionally outer partial shell structures provided. Voids are also provided between the granule structures. As illustrated, the granule structures may include intersecting arms arranged in a substantially planar or intersecting multi-planar structure, and all components may be coated as desired for providing desired granule properties, adhesion, fusion, etc., all in view of biocompatibility considerations. Further, all components of all embodiments may be additively manufactured or the like.

[0062] FIG. 15 is primarily spherical and planar granule structures with porosity provided by various truss and arm structures and optionally outer partial shell structures provided. Voids are also provided between the granule structures.

[0063] FIG. 16 is primarily spherical granule structures with porosity provided by various truss and wrap structures. Voids are also provided between the granule structures. An internal truss structure and / or substantially hollow core may be utilized, with a partial outer shell, optionally including intersecting outer shell pieces or skins that may each traverse a position of the outer shell of the granule structure, emanating from internal arms or otherwise coupled to the internal truss structure. Again, all components may be coated as desired for providing desired granule properties, adhesion, fusion, etc., all in view of biocompatibility considerations. Further, all components of all embodiments may be additively manufactured or the like.

[0064] FIG. 17 is primarily spherical granule structures with porosity provided by various truss and arm structures and optionally outer partial shell structures provided. Voids are also provided between the granule structures. Nobs are provided on the outer surface of the granule structure. The shape provided promotes interlocking of the granule structures.

[0065] Although the present disclosure is illustrated and described with reference to specific embodiments and examples thereof, it will be readily apparent to those of ordinary skill in the art that other embodiments may perform similar functions and / orachieve like results. All such equivalent embodiments and examples are within the spirit and scope of the present disclosure, are contemplated thereby, and are intended to be covered by the following non-limiting claims for all purposes.

Claims

CLAIMSWhat is claimed is:1 . A biocompatible granule structure comprising a body structure having an external dimension on the order of 1 -10 mm, wherein the body structure defines one or more of an internal arm, internal struts, an internal truss structure, an external shell, an external truss structure, a plurality of lobes, a solid internal core, a hollow internal core, and / or a roughened external surface that promote interlocking of the biocompatible granule structure with an adjacent biocompatible granule structure and bony purchase and ingrowth when the biocompatible granule structures are introduced into a void or space in a bone structure or between bone structures to partially fill the volume in a surgical application.

2. The biocompatible granule structure of claim 1 , wherein the body structure is symmetric about one or more axes.

3. The biocompatible granule structure of claim 1 , wherein the body structure is asymmetric about one or more axes.

4. The biocompatible granule structure of claim 1 , wherein the body structure defines one or more channels running through the body structure and adapted to receive flexible elongate structure through the body structure.

5. The biocompatible granule structure of claim 4, wherein the channel is one of a straight tube, a circuitous conduit, or a plurality of interconnected internal voids and external openings of the body structure.

6. The biocompatible granule structure of claim 4, wherein the channel runs through a core of the body structure.

7. The biocompatible granule structure of claim 4, wherein the channel runs adjacent to a core of the body structure.

8. The biocompatible granule structure of claim 4, wherein the channel runs along a major axis of the body structure.

9. The biocompatible granule structure of claim 4, wherein the channel runs along a minor axis of the body structure.

10. The biocompatible granule structure of claim 1 , wherein the body structure is additively manufactured from one of a biocompatible metallic material, a biocompatible ceramic material, and a biocompatible polymeric material.

11. A biocompatible granule assembly comprising a plurality of biocompatible granule structures each comprising a body structure having an external dimension on the order of 1 -10 mm, wherein the body structure defines one or more of an internal arm, internal struts, an internal truss structure, an external shell, an external truss structure, a plurality of lobes, a solid internal core, a hollow internal core, and / or a roughened external surface that promote interlocking of the biocompatible granule structure with an adjacent biocompatible granule structure and bony purchase and ingrowth when the biocompatible granule structures are introduced into a void or space in a bone structure or between bone structures to partially fill the volume in a surgical application, and wherein the body structure defines one or more channels running through the body structure; and a flexible elongate structure comprising one of a wire, a string, a thread, or a suture disposed through a channel of each of the plurality of biocompatible granule structures to hold the plurality of biocompatible granule structures adjacent to one another.

12. The biocompatible granule assembly of claim 11 , wherein the body structure is symmetric about one or more axes.

13. The biocompatible granule assembly of claim 11 , wherein the body structure is asymmetric about one or more axes.

14. The biocompatible granule assembly of claim 11 , wherein the channels are each one of a straight tube, a circuitous conduit, or a plurality of interconnected internal voids and external openings of the body structure.

15. The biocompatible granule assembly of claim 11 , wherein at least some of the channels run through a core of at least some of the body structures.

16. The biocompatible granule assembly of claim 11 , wherein at least some of the channels run adjacent to a core of at least some of the body structures.

17. The biocompatible granule assembly of claim 11 , wherein at least some of the channels run along a major axis of at least some of the body structures.

18. The biocompatible granule assembly of claim 11 , wherein at least some of the channels run along a minor axis of at least some of the body structures.

19. The biocompatible granule assembly of claim 11 , wherein the body structure is additively manufactured from one of a biocompatible metallic material, a biocompatible ceramic material, and a biocompatible polymeric material.

20. A method comprising additively manufacturing a plurality of biocompatible granule structures from one of a biocompatible metallic material, a biocompatible ceramic material, or a biocompatible polymeric material; and threading a flexible elongate structure comprising one of a wire, a string, a thread, or a suture through a channel manufactured into each of the plurality of granule structures to form a surgical implant assembly that is configured to be disposed in a void or spacein a bone structure or between bone structures to partially fill a volume and promote bony ingrowth.

Citation Information

Patent Citations

  • Porous beta-tricalcium phosphate granules and methods for producing same

    US20030049328A1

  • Structured composites as a matrix (scaffold) for the tissue engineering of bones

    US20050233454A1

  • Bi-phasic compressed porous reinforcement materials suitable for implant

    US20100278891A1

  • Body for providing ingrowth and growth of bone tissue and / or connective tissue and method of making such a body

    US7056577B1

  • Ceramic component for bone regeneration

    WO2011068451A2