US20180116802A1 - Fold-Up Containment Device For Bone Defects - Google Patents
Fold-Up Containment Device For Bone Defects Download PDFInfo
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- US20180116802A1 US20180116802A1 US15/801,528 US201715801528A US2018116802A1 US 20180116802 A1 US20180116802 A1 US 20180116802A1 US 201715801528 A US201715801528 A US 201715801528A US 2018116802 A1 US2018116802 A1 US 2018116802A1
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- bone
- graft containment
- mesh sheet
- containment structure
- graft
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
- A61B17/8071—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones for the jaw
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- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8085—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates with pliable or malleable elements or having a mesh-like structure, e.g. small strips
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Definitions
- Mandible defects are often treated with bone grafts and/or implants such as, bone plates, to assist with healing.
- the bone grafts may be placed in the target area using any of a variety of methods. However, without a container for the bone graft, the graft may fall away from a target site before it can be incorporated by the body into the healing bone.
- the present disclosure is directed to a bone graft system
- a bone graft system comprising a two-dimensional mesh sheet sized and shaped to, when folded along fold lines, form a three-dimensional graft containment structure configured to be packed with a bone graft material for placement within a target area of a bone, the mesh sheet including a first end flap connected to a remaining portion of the mesh sheet via a first fold line and a second end flap connected to the remaining portion of the mesh sheet via a second fold line, a third fold line extending from the first fold line to the second fold line so that the remaining portion is configured to be wrapped around folded first and second end flaps to form the graft containment structure, the first and second end flaps substantially corresponding to a profile of the target area of the bone.
- the present disclosure is also directed to a bone graft system
- a bone graft system comprising a graft containment assembly including a plurality of two-dimensional mesh sheets connected to one another along longitudinal edges thereof, each of the mesh sheets sized and shaped so that, when folded along fold lines, each of the mesh sheets form a three-dimensional graft containment structure configured to be packed with a bone graft material, each graft containment structure movable relative to an adjacent graft containment structure to form a desired configuration of the graft containment assembly for placement of the graft containment assembly within a target area of a bone.
- the present disclosure also relates to a method for treating a bone comprising folding a first two-dimensional mesh sheet along fold lines to form a first three-dimensional graft containment structure, the first mesh sheet including a first end flap connected to a remaining portion of the mesh sheet via a first fold line and a second end flap connected to the remaining portion of the mesh sheet via a second fold line, a third fold line extending from the first fold line to the second fold line so that the remaining portion is configured to be wrapped around folded first and second end flaps to form the first graft containment structure, packing the first graft containment structure with a bone graft material, maintaining the first graft containment structure in a closed configuration, so that the bone graft material is held therewithin, positioning the first graft containment structure within a target area of a bone, and fixing the first graft containment structure to the bone.
- FIG. 1 shows a top plan view of a system according to an exemplary embodiment of the present disclosure
- FIG. 2 shows a perspective view of the system of FIG. 1 ;
- FIG. 3 shows another perspective view of the system of FIG. 1 ;
- FIG. 4 shows a perspective view of the system of FIG. 1 , in a folded configuration
- FIG. 5 shows a top plan view of a system according to another exemplary embodiment of the present disclosure
- FIG. 6 shows a perspective view of the system of FIG. 5 , in a folded configuration
- FIG. 7 shows a perspective view of a system according to yet another exemplary embodiment of the present disclosure.
- FIG. 8 shows a perspective view of a mesh sheet according to the system of FIG. 7 ;
- FIG. 9 shows a top plan view of the system of FIG. 7 , in a folded configuration and positioned in a target area of a bone;
- FIG. 10 shows a perspective view of the system FIG. 7 , in a folded configuration and positioned in the target area of the bone;
- FIG. 11 shows a cross-sectional side view of a graft containment structure according to the system of FIG. 7 .
- the present invention may be understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals.
- the present invention relates to the treatment of bone and, in particular, relates to treatments using bone grafts and bone graft substitutes.
- Exemplary embodiments of the present invention describe a graft containment cage configured to be positioned in a gap or space in a target bone (e.g., the mandible) so that graft material may be packed therein to encourage and guide the generation of new bone in the gap/space.
- the cage may be positioned between two separated portions of bone to generate new bone joining the separated portions of bone.
- the graft containment cage may be inserted or positioned within any gap or space of the target bone including, for example, at an end of the bone, so that there is bone only on one side of the graft containment cage, or within a recessed space of the bone, so that three sides of the graft containment cage contact bone.
- the graft containment device of the exemplary embodiment is formed as a two-dimensional mesh sheet that is sized and shaped to be folded-up into a three-dimensional structure that has a shape that substantially corresponds to a shape of a recess or space that is to be filled. Bone graft material or a bone graft substitute material may be packed inside the three-dimensional structure.
- the graft containment device is sized, shaped and structure to treat defects of the mandible.
- the exemplary embodiment is shown and described as being used in treating a mandible, it will be understood by those of skill in the art that the graft containment device of the present invention may also be formed in different shapes and sized to permit use in treating other types of bone which would benefit from the use of a graft containment device.
- a system 100 comprises a two-dimensional mesh sheet 102 sized and shaped to be folded along fold lines 106 , as shown in FIG. 1 , to form a three-dimensional graft containment structure 104 , as shown in FIG. 4 , that is configured to be inserted into a target area of a bone (e.g., to replace a portion of a mandible).
- the mesh sheet 102 is specifically sized and shaped so that, when folded, the graft containment structure 104 may be positioned in a target area—e.g., a space formerly occupied by bone that has been resected.
- the target area may, for example, be located ends of a bone on either side of a portion of bone that has been removed.
- Each of the ends of the graft containment structure 104 may substantially correspond to a profile of an outer surface of a corresponding one of the ends of the separated portions of bone so that the graft containment structure 104 bridges the two separated portions of the bone.
- Graft material may be packed within an interior of the graft containment structure 104 to promote bone growth between the separated portions of bone as would be understood by those skilled in the art.
- the mesh sheet 102 includes a plurality of fold lines 106 along which the mesh sheet 102 is specifically configured to be folded to form the graft containment structure 104 , as shown in FIG. 4 .
- the mesh sheet 102 defines a first surface 122 which, when the mesh sheet 102 is folded into the graft containment structure 104 , forms an interior of the graft containment structure 104 , and a second surface 124 which, when the mesh sheet 102 is folded into the graft containment structure 104 , forms an exterior of the graft containment structure 104 .
- the mesh sheet 102 also defines a first edge 108 and an opposing second edge 110 such that, when the mesh sheet 102 is folded along the fold lines 106 , the resulting graft containment structure 104 extends along a longitudinal axis from a first end 112 corresponding to the first edge 108 to a second end 114 corresponding to the second edge 110 .
- the fold lines 106 may be formed as, for example, living hinges, facilitating folding of the mesh sheet 102 therealong.
- the mesh sheet 102 includes at least three-fold lines 106 which divide the mesh sheet 102 into segments defining distinct surfaces of the graft containment structure 104 .
- the mesh sheet 102 may be shaped to include a first end flap 116 and a second end flap 118 , each of which is connected to a remaining portion 120 of the mesh sheet 102 via one of the fold lines 106 .
- the first end flap 116 is connected to the remaining portion 120 of the mesh sheet 102 via a first one of the fold lines 106 a and the second end flap 118 is connected to the remaining portion 120 via a second one of the fold lines 106 b.
- the first and second end flaps 116 , 118 may be folded along the first and second fold lines 106 a, 106 b, respectively, toward the first surface 122 .
- the first and second end flaps 116 , 118 extend transverse to the longitudinal axis of the graft containment structure 104 to define first and second ends 112 , 114 , respectively, of the graft containment structure 104 .
- the first and second end flaps 116 , 118 fold to extend substantially perpendicular to the longitudinal axis of the graft containment structure 104 .
- a shape of each of the first and second end flaps 116 , 118 may generally be formed to correspond to a profile of an outer surface of the separated portions of bone.
- a third one of the fold lines 106 c extends from the first edge 108 to the second edge 110 and connects the first and second fold lines 106 a, 106 b.
- the mesh sheet 102 may be folded along the third fold line 106 c ( FIG. 2 ) and the remaining portion 120 may be wrapped around the folded first and second end flaps 116 , 118 ( FIG. 3 ) so that the first surface 122 extends about a perimeter of the first and second end flaps 116 , 118 , in contact with edges 130 , 132 , respectively, thereof, to form a substantially closed space within the containment structure 104 ( FIG.
- the graft containment structure 104 may be filled with graft material during or before folding of the mesh sheet 102 .
- the graft containment structure 104 may be maintained in the closed configuration in any of a variety of ways.
- the graft containment structure 104 may be closed via suturing and/or hooking.
- the mesh sheet 102 includes an overlapping portion 126 connected to the remaining portion 120 of the mesh sheet 102 via a fourth fold line 106 d.
- the overlapping portion 126 overlaps a portion of the remaining portion 120 to facilitate closing of the graft containment structure 104 .
- This overlapping portion 126 may be sutured or otherwise attached to the remaining portion 120 to maintain the graft containment structure 104 in the closed configuration, thereby holding the graft material therein.
- the mesh sheet 102 may be shaped so that, in one embodiment, upon completion of the folding process, the graft containment structure 104 includes an overhang 128 at each of the first and second ends 112 , 114 .
- a portion of the mesh sheet 102 may extend beyond each of the folded first and second flaps 116 , 118 so that, when the graft containment structure 104 is positioned in the target area of the bone, the overhang 128 extends over ends of the separated portions of bone.
- the overhang 128 may be affixed to the bone via, for example, a bone fixation element, to fix the graft containment structure 104 relative to the bone.
- the mesh sheet 102 may be manufactured in a variety of shapes and sizes so that a surgeon or other user may select a desired size and shape most suitable for treating a target bone.
- a surgeon or other user may trim the mesh sheet 102 to achieve a graft containment structure 104 better suited for the portion of the target bone being treated.
- portions of the overhang 128 and/or the first and second end flaps 116 , 118 may be trimmed to achieve a desired fit.
- the mesh sheet 102 may include trim lines in the form of, for example, split lines, to guide the proper trimming thereof
- the mesh sheet 102 may be formed of materials such as resorbable polymers (e.g., PCL) or non-resorbable polymers, metals (e.g., titanium) or composites (e.g., graphene, elastomer), depending on an anatomical region being treated and an indication.
- the mesh sheet 102 may include a plurality of pores extending through the material thereof, the pores shaped to promote vascularization of the bone while preventing graft material packed in the graft containment structure 104 from falling thereoutof.
- the pores may also be sized and shaped to receive a fixation element therein.
- the pores may be sized to receive a fixation screw having a 1.8 mm diameter.
- the mesh sheet 102 may be formed via a plurality of intersecting struts formed of a desired material, the struts intersecting to define the pores.
- the mesh sheet 102 is configured to be folded along fold lines 106 to form the graft containment structure 104 .
- the first and second end flaps 116 , 118 are folded inward, toward the first surface 122 until the first and second end flaps 116 , 118 are substantially perpendicular with respect to the remaining portion 120 of the mesh sheet 102 .
- the remaining portion 120 is wrapped around a perimeter of the first and second end flaps 116 , 118 so that the first surface 122 contacts the edges 130 , 132 of the first and second flaps, respectively.
- the mesh sheet 102 may be trimmed prior to folding of the mesh sheet 102 to better suit the target area of the bone being treated.
- Graft material may be packed into the graft containment structure 104 as the mesh sheet 102 is being folded into the desired shape. Once folding of the mesh sheet 102 has been completed, the graft containment structure 104 forms a substantially closed space in which the graft material is held, preventing the graft material from falling thereoutof. Edges and/or surfaces of the mesh sheet 102 which are brought into contact with one another to form the graft containment structure 104 may be sutured, hooked or otherwise affixed to maintain the shape of the graft containment structure.
- the graft containment structure 104 may be placed in a desired positioned in a recess or gap between two portions of the target bone.
- the graft containment structure 104 may be positioned such that the first and second ends 112 , 114 of the graft containment structure 104 are substantially in alignment with ends separated portions of the bone.
- the graft containment structure 104 may be further trimmed, if so desired, to aid in positioning of the graft containment structure 104 in the target area of the bone.
- overhangs 128 at the first and second ends 112 , 114 of the grail containment structure 104 may overlap the ends of the separated portions of bone.
- These overhangs 128 may be fixed to the bone via, for example, bone fixation elements such as bone screws.
- the graft containment structure 104 may also be fixed to the bone via a bone plate, extending along a length of the graft containment structure 104 so that ends of the bone plate extend over ends of the separated portions of bone.
- the bone plate may be fixed both to the graft containment structure 104 and to the bone.
- the exemplary embodiment describes using a single graft containment structure 104 to treat the target area
- multiple graft containment structures 104 may be utilized to treat the target area. This may, however, require trimming of the mesh sheets 102 and/or graft containment structures 104 to fit the target area.
- the graft containment structures 104 may be attached to one another, end to end, to form a desired length and/or curvature useful for treating the target area.
- a system 200 may be substantially similar to the system 100 described above, comprising a mesh sheet 202 configured to be folded along fold lines 206 a, 206 b to form a graft containment structure 204 .
- the graft containment structure 204 may be specifically designed using a three-dimensional digital environment to match a patient's specific bone dimensions, which may be obtained via, for example, 3D imaging of a target bone.
- the 3D scan may be used to generate desired dimensions of the graft containment structure 204 such as, for example, length, curvature, and cross-sectional area.
- the system 200 may use the mesh sheet 102 of the system 100 as a two-dimensional template for the mesh sheet 202 .
- the patient-specific mesh sheet 202 is constructed.
- the mesh sheet 202 is specifically sized and shaped according to the desired dimensions and is formed to include fold lines 206 a, 206 b such that, when folded along fold lines 206 a, 206 b, a graft containment structure 204 having the desired dimensions is formed.
- the mesh sheet 202 may be substantially similar to the mesh sheet 102 described above in regard to the system 100 .
- the mesh sheet 202 may include curved longitudinal edges 234 , 236 and opposing first and second lateral edges 208 , 210 which taper relative to one another as they extend from a first one of the longitudinal edges 234 toward a second one of the longitudinal edges 236 .
- the mesh sheet 202 may also include additional fold lines 206 a, 206 b and slits 238 along portions thereof to achieve, when folded, a desired curvature and shape of the graft containment structure 204 .
- the mesh sheet 202 is particularly constructed to treat a patient's mandible.
- the mesh sheet 202 includes a first end flap 216 and a second end flap 218 which, when folded, define first and second ends 212 , 214 , respectively, of the graft containment structure 204 .
- the first and second end flaps 216 , 218 are specifically sized and shaped to correspond to a profile of the target area of the mandible of the patient.
- Longitudinally extending fold lines 206 a are designed so that, when folded therealong, the resulting graft containment structure 204 has the desired cross-sectional area for treating the target area of the patient's mandible.
- the mesh sheet 202 further includes slits 238 extending therealong in alignment with a portion laterally extending fold lines 206 b so that, when folded, adjacent portions 240 of the mesh sheet 202 , separated from one another via the laterally extending fold lines 206 b, may be bent relative to one another to achieve the desired curvature of the graft containment structure 204 .
- the mesh sheet 202 may also be shaped so that, when folded, the graft containment structure 204 includes overhangs 228 extending beyond the folded first and second end flaps 216 , 218 .
- the overhangs 228 may extend over ends of the separated portions of the bone so that the graft containment structure 204 may be fixed to the bone via these overhangs 228 .
- the system 200 may be utilized in substantially the same manner as described above with respect to the system 100 .
- the mesh sheet 202 may be folded along fold lines 206 a, 206 b to construct the patient-specific graft containment structure 204 .
- the graft containment structure 204 may be packed with graft material during the folding of the mesh sheet 202 .
- the graft containment structure 204 will have a desired size, cross-sectional shape and curvature for treating the target area of the patient.
- a system 300 may be substantially similar to the systems 100 , 200 described above.
- the system 300 comprises a graft containment assembly 301 including a plurality of mesh sheets 302 connected to one another along first longitudinal edges 334 thereof, as shown in FIG. 7 .
- Each of the mesh sheets 302 may be substantially similar to the mesh sheets 102 , 202 , and may be individually folded to form graft containment structures 304 which, together, form a graft containment device 303 for treating a target area of a patient's bone.
- each of the resulting graft containment structures 304 may be positioned/oriented with respect to one another to obtain a desired curvature of the assembly 301 to fit a target area of a bone.
- the system 300 may be specifically designed using a three dimensional digital environment to match a patient's specific bone dimensions, which may be obtained via, for example, 3D imaging of a target bone.
- the 3D scan may be used to generate desired dimensions of the graft containment assembly 301 such as, for example, length, curvature, and cross-sectional area.
- patient-specific mesh sheet 302 which may be folded to form the desired assembly of graft containment structures 304 .
- system 300 or any of the embodiments described may be made in standard sizes which a physician may trim, bend or otherwise customize to suit individual patients in any known manner(s).
- Each of the mesh sheets 302 may be substantially similar to the mesh sheet 102 , described above in regard to the system 100 .
- Each mesh sheet 302 is two-dimensional and is defined via a first surface 322 which, when the mesh sheet 302 is folded toward the graft containment structure 304 forms an interior of the graft containment structure 304 , and a second surface 324 which, when the mesh sheet 302 is folded toward the graft containment structure 304 forms an exterior of the graft containment structure.
- Each mesh sheet 302 may be further defined via first and second longitudinal edges 334 , 336 and first and second lateral edges 108 , 110 .
- each mesh sheet 302 is sized and shaped to be folded along fold lines 306 to form a desired graft containment structure 304 of the graft containment assembly 301 .
- Each of the graft containment structures 304 may be filled with graft material so that the graft containment assembly 301 may be placed within the target area to promote bone growth and healing.
- each mesh sheet 302 a first end flap 316 and a second end flap 318 connected to a remaining portion 320 of each mesh sheet 302 via a first fold line 306 a and a second fold line 306 b, respectively.
- the first and second end flaps 316 , 318 may form first and second ends 312 , 314 , respectively, of the graft containment structure 304 .
- the mesh sheet 302 may include a third fold line 306 c along which the remaining portion 320 may be folded to wrap the remaining portion 320 about a perimeter of the first and second end flaps 316 , 318 .
- the mesh sheet 302 may be folded to form the graft containment structure 304 in substantially the same was as described above for the system 100 .
- Graft material may be packed within each of the graft containment structures 304 of the assembly 301 during the folding process.
- the exemplary embodiment shows and describes three-fold lines 306 , it will be understood by those of skill in the art that the mesh sheets 302 may include more than three-fold lines 306 to form, for example, overlapping portions, similarly to the mesh sheet 102 .
- each of the mesh sheets 302 may have varying sizes and shapes so that a cross-sectional area of the assembly 301 may have a varying size and shape along a length thereof to mimic a naturally changing profile of the bone (e.g., mandible).
- first and second end flaps 316 , 318 of each of the mesh sheets 302 may vary in size and shape so that the resulting graft containment structures 304 may establish a desired profile within the target area.
- the graft containment assembly 301 may be positioned, as desired, within the target area of the bone, as shown in FIGS. 9 and 10 . Since the mesh sheets 302 are connected to one another along the first longitudinal edges 334 , the formed graft containment structures 304 may be positioned and/or oriented with respect to one another (e.g., angled) to form a desired configuration (e.g., curvature) of the assembly 301 suitable for treating the target area.
- a desired configuration e.g., curvature
- the graft containment assembly may be affixed to separated ends of the bone via, for example, an overhang 328 extending from a first one of the mesh sheets 302 a and a last one of the mesh sheets 302 b to extend over the separated ends of the bone when the assembly 301 is positioned therein.
- the system 300 may further comprise an implant such as, for example, a bone plate 340 for providing additional fixation.
- the bone plate 340 may extend across the graft containment structures 304 such that ends 342 , 344 thereof extend along the ends of the separated portions of bone.
- the bone plate 340 may be fixed to each of the graft containment structures 304 to maintain adjacent graft containment structures 304 in a desired position/orientation relative to one another.
- the graft containment structures 304 may be formed with grooves 346 sized and shaped to receive the bone plate 340 therein so that, when the bone plate 340 is placed within the grooves 346 of the graft containment structures 304 , the bone plate 340 prevents relative movement between the bone plate 340 and the bone graft containment structures 304 and relative movement between the bone graft containment structures 304 of the assembly 301 .
- the grooves 346 may be formed via additional fold lines 306 extending along the mesh sheets 302 .
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Abstract
Description
- The present application claims priority to U.S. Provisional Patent Application Serial No. 62/417,052 filed on Nov. 3, 2016. The entire disclosure of the above application is expressly incorporated herein by reference.
- Mandible defects are often treated with bone grafts and/or implants such as, bone plates, to assist with healing. The bone grafts may be placed in the target area using any of a variety of methods. However, without a container for the bone graft, the graft may fall away from a target site before it can be incorporated by the body into the healing bone.
- The present disclosure is directed to a bone graft system comprising a two-dimensional mesh sheet sized and shaped to, when folded along fold lines, form a three-dimensional graft containment structure configured to be packed with a bone graft material for placement within a target area of a bone, the mesh sheet including a first end flap connected to a remaining portion of the mesh sheet via a first fold line and a second end flap connected to the remaining portion of the mesh sheet via a second fold line, a third fold line extending from the first fold line to the second fold line so that the remaining portion is configured to be wrapped around folded first and second end flaps to form the graft containment structure, the first and second end flaps substantially corresponding to a profile of the target area of the bone.
- The present disclosure is also directed to a bone graft system comprising a graft containment assembly including a plurality of two-dimensional mesh sheets connected to one another along longitudinal edges thereof, each of the mesh sheets sized and shaped so that, when folded along fold lines, each of the mesh sheets form a three-dimensional graft containment structure configured to be packed with a bone graft material, each graft containment structure movable relative to an adjacent graft containment structure to form a desired configuration of the graft containment assembly for placement of the graft containment assembly within a target area of a bone.
- The present disclosure also relates to a method for treating a bone comprising folding a first two-dimensional mesh sheet along fold lines to form a first three-dimensional graft containment structure, the first mesh sheet including a first end flap connected to a remaining portion of the mesh sheet via a first fold line and a second end flap connected to the remaining portion of the mesh sheet via a second fold line, a third fold line extending from the first fold line to the second fold line so that the remaining portion is configured to be wrapped around folded first and second end flaps to form the first graft containment structure, packing the first graft containment structure with a bone graft material, maintaining the first graft containment structure in a closed configuration, so that the bone graft material is held therewithin, positioning the first graft containment structure within a target area of a bone, and fixing the first graft containment structure to the bone.
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FIG. 1 shows a top plan view of a system according to an exemplary embodiment of the present disclosure; -
FIG. 2 shows a perspective view of the system ofFIG. 1 ; -
FIG. 3 shows another perspective view of the system ofFIG. 1 ; -
FIG. 4 shows a perspective view of the system ofFIG. 1 , in a folded configuration; -
FIG. 5 shows a top plan view of a system according to another exemplary embodiment of the present disclosure; -
FIG. 6 shows a perspective view of the system ofFIG. 5 , in a folded configuration; -
FIG. 7 shows a perspective view of a system according to yet another exemplary embodiment of the present disclosure; -
FIG. 8 shows a perspective view of a mesh sheet according to the system ofFIG. 7 ; -
FIG. 9 shows a top plan view of the system ofFIG. 7 , in a folded configuration and positioned in a target area of a bone; -
FIG. 10 shows a perspective view of the systemFIG. 7 , in a folded configuration and positioned in the target area of the bone; and -
FIG. 11 shows a cross-sectional side view of a graft containment structure according to the system ofFIG. 7 . - The present invention may be understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The present invention relates to the treatment of bone and, in particular, relates to treatments using bone grafts and bone graft substitutes. Exemplary embodiments of the present invention describe a graft containment cage configured to be positioned in a gap or space in a target bone (e.g., the mandible) so that graft material may be packed therein to encourage and guide the generation of new bone in the gap/space. In one exemplary embodiment, the cage may be positioned between two separated portions of bone to generate new bone joining the separated portions of bone. It will be understood by those of skill in the art, however, that the graft containment cage may be inserted or positioned within any gap or space of the target bone including, for example, at an end of the bone, so that there is bone only on one side of the graft containment cage, or within a recessed space of the bone, so that three sides of the graft containment cage contact bone. The graft containment device of the exemplary embodiment is formed as a two-dimensional mesh sheet that is sized and shaped to be folded-up into a three-dimensional structure that has a shape that substantially corresponds to a shape of a recess or space that is to be filled. Bone graft material or a bone graft substitute material may be packed inside the three-dimensional structure. In one embodiment, the graft containment device is sized, shaped and structure to treat defects of the mandible. Although the exemplary embodiment is shown and described as being used in treating a mandible, it will be understood by those of skill in the art that the graft containment device of the present invention may also be formed in different shapes and sized to permit use in treating other types of bone which would benefit from the use of a graft containment device.
- As shown in
FIGS. 1-4 , asystem 100 according to an exemplary embodiment of the present disclosure comprises a two-dimensional mesh sheet 102 sized and shaped to be folded alongfold lines 106, as shown inFIG. 1 , to form a three-dimensionalgraft containment structure 104, as shown inFIG. 4 , that is configured to be inserted into a target area of a bone (e.g., to replace a portion of a mandible). Themesh sheet 102 is specifically sized and shaped so that, when folded, thegraft containment structure 104 may be positioned in a target area—e.g., a space formerly occupied by bone that has been resected. The target area may, for example, be located ends of a bone on either side of a portion of bone that has been removed. Each of the ends of thegraft containment structure 104 may substantially correspond to a profile of an outer surface of a corresponding one of the ends of the separated portions of bone so that thegraft containment structure 104 bridges the two separated portions of the bone. Graft material may be packed within an interior of thegraft containment structure 104 to promote bone growth between the separated portions of bone as would be understood by those skilled in the art. - The
mesh sheet 102, as shown inFIG. 1 , includes a plurality offold lines 106 along which themesh sheet 102 is specifically configured to be folded to form thegraft containment structure 104, as shown inFIG. 4 . Themesh sheet 102 defines afirst surface 122 which, when themesh sheet 102 is folded into thegraft containment structure 104, forms an interior of thegraft containment structure 104, and asecond surface 124 which, when themesh sheet 102 is folded into thegraft containment structure 104, forms an exterior of thegraft containment structure 104. Themesh sheet 102 also defines afirst edge 108 and an opposingsecond edge 110 such that, when themesh sheet 102 is folded along thefold lines 106, the resultinggraft containment structure 104 extends along a longitudinal axis from afirst end 112 corresponding to thefirst edge 108 to asecond end 114 corresponding to thesecond edge 110. Thefold lines 106 may be formed as, for example, living hinges, facilitating folding of themesh sheet 102 therealong. - In one embodiment, the
mesh sheet 102 includes at least three-foldlines 106 which divide themesh sheet 102 into segments defining distinct surfaces of thegraft containment structure 104. Themesh sheet 102 may be shaped to include afirst end flap 116 and asecond end flap 118, each of which is connected to aremaining portion 120 of themesh sheet 102 via one of thefold lines 106. In particular, thefirst end flap 116 is connected to theremaining portion 120 of themesh sheet 102 via a first one of thefold lines 106 a and thesecond end flap 118 is connected to theremaining portion 120 via a second one of thefold lines 106 b. The first andsecond end flaps second fold lines first surface 122. When folded, the first andsecond end flaps graft containment structure 104 to define first andsecond ends graft containment structure 104. In one example, the first andsecond end flaps graft containment structure 104. As would be understood by those skilled in the art, a shape of each of the first andsecond end flaps - A third one of the
fold lines 106 c extends from thefirst edge 108 to thesecond edge 110 and connects the first andsecond fold lines mesh sheet 102 along the first andsecond fold lines mesh sheet 102 may be folded along thethird fold line 106 c (FIG. 2 ) and theremaining portion 120 may be wrapped around the folded first andsecond end flaps 116, 118 (FIG. 3 ) so that thefirst surface 122 extends about a perimeter of the first andsecond end flaps edges FIG. 4 ) in which graft material may be held. As would be understood by those of skill in the art thegraft containment structure 104 may be filled with graft material during or before folding of themesh sheet 102. Thegraft containment structure 104 may be maintained in the closed configuration in any of a variety of ways. For example, thegraft containment structure 104 may be closed via suturing and/or hooking. - In a further embodiment, the
mesh sheet 102 includes an overlappingportion 126 connected to theremaining portion 120 of themesh sheet 102 via afourth fold line 106 d. When folded along the fourth fold line, the overlappingportion 126 overlaps a portion of theremaining portion 120 to facilitate closing of thegraft containment structure 104. This overlappingportion 126 may be sutured or otherwise attached to theremaining portion 120 to maintain thegraft containment structure 104 in the closed configuration, thereby holding the graft material therein. - The
mesh sheet 102 may be shaped so that, in one embodiment, upon completion of the folding process, thegraft containment structure 104 includes anoverhang 128 at each of the first andsecond ends mesh sheet 102 may extend beyond each of the folded first andsecond flaps graft containment structure 104 is positioned in the target area of the bone, theoverhang 128 extends over ends of the separated portions of bone. Theoverhang 128 may be affixed to the bone via, for example, a bone fixation element, to fix thegraft containment structure 104 relative to the bone. - The
mesh sheet 102 may be manufactured in a variety of shapes and sizes so that a surgeon or other user may select a desired size and shape most suitable for treating a target bone. In addition or alternatively, a surgeon or other user may trim themesh sheet 102 to achieve agraft containment structure 104 better suited for the portion of the target bone being treated. For example, portions of theoverhang 128 and/or the first andsecond end flaps mesh sheet 102 may include trim lines in the form of, for example, split lines, to guide the proper trimming thereof - The
mesh sheet 102 may be formed of materials such as resorbable polymers (e.g., PCL) or non-resorbable polymers, metals (e.g., titanium) or composites (e.g., graphene, elastomer), depending on an anatomical region being treated and an indication. Themesh sheet 102 may include a plurality of pores extending through the material thereof, the pores shaped to promote vascularization of the bone while preventing graft material packed in thegraft containment structure 104 from falling thereoutof. The pores may also be sized and shaped to receive a fixation element therein. In one example, the pores may be sized to receive a fixation screw having a 1.8 mm diameter. In another embodiment, themesh sheet 102 may be formed via a plurality of intersecting struts formed of a desired material, the struts intersecting to define the pores. - According to an exemplary method, the
mesh sheet 102 is configured to be folded alongfold lines 106 to form thegraft containment structure 104. In particular, the first and second end flaps 116, 118 are folded inward, toward thefirst surface 122 until the first and second end flaps 116, 118 are substantially perpendicular with respect to the remainingportion 120 of themesh sheet 102. The remainingportion 120 is wrapped around a perimeter of the first and second end flaps 116, 118 so that thefirst surface 122 contacts theedges mesh sheet 102 may be trimmed prior to folding of themesh sheet 102 to better suit the target area of the bone being treated. Graft material may be packed into thegraft containment structure 104 as themesh sheet 102 is being folded into the desired shape. Once folding of themesh sheet 102 has been completed, thegraft containment structure 104 forms a substantially closed space in which the graft material is held, preventing the graft material from falling thereoutof. Edges and/or surfaces of themesh sheet 102 which are brought into contact with one another to form thegraft containment structure 104 may be sutured, hooked or otherwise affixed to maintain the shape of the graft containment structure. - Once the
graft containment structure 104 is in the desired shape and is packed with graft material, as desired, thegraft containment structure 104 may be placed in a desired positioned in a recess or gap between two portions of the target bone. For example, thegraft containment structure 104 may be positioned such that the first and second ends 112, 114 of thegraft containment structure 104 are substantially in alignment with ends separated portions of the bone. Thegraft containment structure 104 may be further trimmed, if so desired, to aid in positioning of thegraft containment structure 104 in the target area of the bone. In one embodiment, overhangs 128 at the first and second ends 112, 114 of thegrail containment structure 104 may overlap the ends of the separated portions of bone. Theseoverhangs 128 may be fixed to the bone via, for example, bone fixation elements such as bone screws. Thegraft containment structure 104 may also be fixed to the bone via a bone plate, extending along a length of thegraft containment structure 104 so that ends of the bone plate extend over ends of the separated portions of bone. The bone plate may be fixed both to thegraft containment structure 104 and to the bone. - Although the exemplary embodiment describes using a single
graft containment structure 104 to treat the target area, multiplegraft containment structures 104 may be utilized to treat the target area. This may, however, require trimming of themesh sheets 102 and/orgraft containment structures 104 to fit the target area. In one embodiment, thegraft containment structures 104 may be attached to one another, end to end, to form a desired length and/or curvature useful for treating the target area. - According to another exemplary embodiment, as shown in
FIGS. 5 and 6 , asystem 200 may be substantially similar to thesystem 100 described above, comprising amesh sheet 202 configured to be folded alongfold lines graft containment structure 204. Thegraft containment structure 204, however, may be specifically designed using a three-dimensional digital environment to match a patient's specific bone dimensions, which may be obtained via, for example, 3D imaging of a target bone. In particular, the 3D scan may be used to generate desired dimensions of thegraft containment structure 204 such as, for example, length, curvature, and cross-sectional area. These dimensions are used to design a virtual 3D shape which may then be translated to a digital two-dimensional design to construct a patient-specific mesh sheet 202. Thesystem 200 may use themesh sheet 102 of thesystem 100 as a two-dimensional template for themesh sheet 202. Using the desired dimensions of thegraft containment structure 204 and the mesh template, the patient-specific mesh sheet 202 is constructed. Themesh sheet 202 is specifically sized and shaped according to the desired dimensions and is formed to includefold lines fold lines graft containment structure 204 having the desired dimensions is formed. - The
mesh sheet 202 may be substantially similar to themesh sheet 102 described above in regard to thesystem 100. Themesh sheet 202 may include curvedlongitudinal edges lateral edges longitudinal edges 234 toward a second one of thelongitudinal edges 236. Themesh sheet 202 may also includeadditional fold lines graft containment structure 204. - In one embodiment, the
mesh sheet 202 is particularly constructed to treat a patient's mandible. Similarly to themesh sheet 102, themesh sheet 202 includes afirst end flap 216 and asecond end flap 218 which, when folded, define first and second ends 212, 214, respectively, of thegraft containment structure 204. The first and second end flaps 216, 218 are specifically sized and shaped to correspond to a profile of the target area of the mandible of the patient. Longitudinally extendingfold lines 206 a are designed so that, when folded therealong, the resultinggraft containment structure 204 has the desired cross-sectional area for treating the target area of the patient's mandible. Themesh sheet 202 further includesslits 238 extending therealong in alignment with a portion laterally extendingfold lines 206 b so that, when folded, adjacent portions 240 of themesh sheet 202, separated from one another via the laterally extendingfold lines 206 b, may be bent relative to one another to achieve the desired curvature of thegraft containment structure 204. - Similarly to the
mesh sheet 102, themesh sheet 202 may also be shaped so that, when folded, thegraft containment structure 204 includesoverhangs 228 extending beyond the folded first and second end flaps 216, 218. Theoverhangs 228 may extend over ends of the separated portions of the bone so that thegraft containment structure 204 may be fixed to the bone via theseoverhangs 228. - The
system 200 may be utilized in substantially the same manner as described above with respect to thesystem 100. In particular, themesh sheet 202 may be folded alongfold lines graft containment structure 204. Thegraft containment structure 204 may be packed with graft material during the folding of themesh sheet 202. As described above, thegraft containment structure 204 will have a desired size, cross-sectional shape and curvature for treating the target area of the patient. - As shown in
FIGS. 7-11 , asystem 300 may be substantially similar to thesystems system 300, however, comprises agraft containment assembly 301 including a plurality ofmesh sheets 302 connected to one another along firstlongitudinal edges 334 thereof, as shown inFIG. 7 . Each of themesh sheets 302 may be substantially similar to themesh sheets graft containment structures 304 which, together, form agraft containment device 303 for treating a target area of a patient's bone. Since themesh sheets 302 are connected along the firstlongitudinal edges 334, upon folding of themesh sheets 302, each of the resultinggraft containment structures 304 may be positioned/oriented with respect to one another to obtain a desired curvature of theassembly 301 to fit a target area of a bone. Similarly to thesystem 200, thesystem 300 may be specifically designed using a three dimensional digital environment to match a patient's specific bone dimensions, which may be obtained via, for example, 3D imaging of a target bone. In particular, the 3D scan may be used to generate desired dimensions of thegraft containment assembly 301 such as, for example, length, curvature, and cross-sectional area. These dimensions are then translated to a digital two-dimensional design to construct patient-specific mesh sheet 302, which may be folded to form the desired assembly ofgraft containment structures 304. Alternatively, thesystem 300 or any of the embodiments described, may be made in standard sizes which a physician may trim, bend or otherwise customize to suit individual patients in any known manner(s). - Each of the
mesh sheets 302, as shown inFIG. 8 , may be substantially similar to themesh sheet 102, described above in regard to thesystem 100. Eachmesh sheet 302 is two-dimensional and is defined via afirst surface 322 which, when themesh sheet 302 is folded toward thegraft containment structure 304 forms an interior of thegraft containment structure 304, and asecond surface 324 which, when themesh sheet 302 is folded toward thegraft containment structure 304 forms an exterior of the graft containment structure. Eachmesh sheet 302 may be further defined via first and secondlongitudinal edges lateral edges mesh sheet 102, eachmesh sheet 302 is sized and shaped to be folded alongfold lines 306 to form a desiredgraft containment structure 304 of thegraft containment assembly 301. Each of thegraft containment structures 304 may be filled with graft material so that thegraft containment assembly 301 may be placed within the target area to promote bone growth and healing. In particular, eachmesh sheet 302 afirst end flap 316 and asecond end flap 318 connected to a remainingportion 320 of eachmesh sheet 302 via afirst fold line 306 a and asecond fold line 306 b, respectively. When themesh sheet 302 is folded, the first and second end flaps 316, 318 may form first and second ends 312, 314, respectively, of thegraft containment structure 304. - The
mesh sheet 302 may include athird fold line 306 c along which the remainingportion 320 may be folded to wrap the remainingportion 320 about a perimeter of the first and second end flaps 316, 318. Themesh sheet 302 may be folded to form thegraft containment structure 304 in substantially the same was as described above for thesystem 100. Graft material may be packed within each of thegraft containment structures 304 of theassembly 301 during the folding process. Although the exemplary embodiment shows and describesthree-fold lines 306, it will be understood by those of skill in the art that themesh sheets 302 may include more thanthree-fold lines 306 to form, for example, overlapping portions, similarly to themesh sheet 102. - It will be understood by those of skill in the art that each of the
mesh sheets 302 may have varying sizes and shapes so that a cross-sectional area of theassembly 301 may have a varying size and shape along a length thereof to mimic a naturally changing profile of the bone (e.g., mandible). In particular, first and second end flaps 316, 318 of each of themesh sheets 302 may vary in size and shape so that the resultinggraft containment structures 304 may establish a desired profile within the target area. - Once each of the
mesh sheets 302 have been folded and packed with grail material, thegraft containment assembly 301 may be positioned, as desired, within the target area of the bone, as shown inFIGS. 9 and 10 . Since themesh sheets 302 are connected to one another along the firstlongitudinal edges 334, the formedgraft containment structures 304 may be positioned and/or oriented with respect to one another (e.g., angled) to form a desired configuration (e.g., curvature) of theassembly 301 suitable for treating the target area. The graft containment assembly may be affixed to separated ends of the bone via, for example, anoverhang 328 extending from a first one of themesh sheets 302 a and a last one of themesh sheets 302 b to extend over the separated ends of the bone when theassembly 301 is positioned therein. As shown inFIG. 10 , thesystem 300 may further comprise an implant such as, for example, abone plate 340 for providing additional fixation. Thebone plate 340 may extend across thegraft containment structures 304 such that ends 342, 344 thereof extend along the ends of the separated portions of bone. Thebone plate 340 may be fixed to each of thegraft containment structures 304 to maintain adjacentgraft containment structures 304 in a desired position/orientation relative to one another. - As shown in
FIG. 11 , in a further embodiment, thegraft containment structures 304 may be formed withgrooves 346 sized and shaped to receive thebone plate 340 therein so that, when thebone plate 340 is placed within thegrooves 346 of thegraft containment structures 304, thebone plate 340 prevents relative movement between thebone plate 340 and the bonegraft containment structures 304 and relative movement between the bonegraft containment structures 304 of theassembly 301. In one embodiment, thegrooves 346 may be formed viaadditional fold lines 306 extending along themesh sheets 302. - It will be understood by those of skill in the art that modifications and variations may be made in the structure and methodology of the present invention, without departing from the spirit or the scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention, provided that they come within the scope of the appended claims and their equivalents.
Claims (22)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
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US15/801,528 US20180116802A1 (en) | 2016-11-03 | 2017-11-02 | Fold-Up Containment Device For Bone Defects |
US17/305,031 US11633284B2 (en) | 2016-11-03 | 2021-06-29 | Fold-up containment device for bone defects |
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US201662417052P | 2016-11-03 | 2016-11-03 | |
US15/801,528 US20180116802A1 (en) | 2016-11-03 | 2017-11-02 | Fold-Up Containment Device For Bone Defects |
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US17/305,031 Active US11633284B2 (en) | 2016-11-03 | 2021-06-29 | Fold-up containment device for bone defects |
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US (2) | US20180116802A1 (en) |
EP (1) | EP3534846A2 (en) |
JP (1) | JP7094951B2 (en) |
CN (1) | CN109906064B (en) |
AU (1) | AU2017353846A1 (en) |
BR (1) | BR112019008758A2 (en) |
CA (1) | CA3042275A1 (en) |
WO (1) | WO2018085526A2 (en) |
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US10357367B2 (en) * | 2017-09-11 | 2019-07-23 | DePuy Synthes Products, Inc. | Patient-specific mandible graft cage |
US11213395B2 (en) * | 2017-02-06 | 2022-01-04 | DePuy Synthes Products, Inc. | Bendable graft containment cage |
WO2022047069A1 (en) * | 2020-08-28 | 2022-03-03 | Warsaw Orthopedic, Inc | Rollable bone implant for enclosing bone material |
US11337816B2 (en) * | 2019-10-18 | 2022-05-24 | Industrial Technology Research Institute | Reconstruction prosthesis |
US11504240B2 (en) | 2020-06-04 | 2022-11-22 | DePuy Synthes Products, Inc. | Modular bone graft cage |
US11957589B2 (en) * | 2021-08-27 | 2024-04-16 | Acumed Llc | Non-patient-specific craniofacial implants for correcting and/or preventing temporal or pterional deformities |
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Also Published As
Publication number | Publication date |
---|---|
CN109906064B (en) | 2021-09-10 |
US20210322171A1 (en) | 2021-10-21 |
JP7094951B2 (en) | 2022-07-04 |
CA3042275A1 (en) | 2018-05-11 |
CN109906064A (en) | 2019-06-18 |
EP3534846A2 (en) | 2019-09-11 |
WO2018085526A2 (en) | 2018-05-11 |
JP2019532773A (en) | 2019-11-14 |
US11633284B2 (en) | 2023-04-25 |
WO2018085526A3 (en) | 2018-07-19 |
AU2017353846A1 (en) | 2019-05-16 |
BR112019008758A2 (en) | 2019-07-16 |
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