U.S. patent application number 15/801528 was filed with the patent office on 2018-05-03 for fold-up containment device for bone defects.
The applicant listed for this patent is DePuy Synthes Products, Inc.. Invention is credited to Steffan Daniel, Andre Furrer.
Application Number | 20180116802 15/801528 |
Document ID | / |
Family ID | 61257089 |
Filed Date | 2018-05-03 |
United States Patent
Application |
20180116802 |
Kind Code |
A1 |
Daniel; Steffan ; et
al. |
May 3, 2018 |
Fold-Up Containment Device For Bone Defects
Abstract
A bone graft system includes 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.
Inventors: |
Daniel; Steffan; (Zuchwil,
CH) ; Furrer; Andre; (Zuchwil, CH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
DePuy Synthes Products, Inc. |
Raynham |
MA |
US |
|
|
Family ID: |
61257089 |
Appl. No.: |
15/801528 |
Filed: |
November 2, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62417052 |
Nov 3, 2016 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2002/30153
20130101; A61F 2002/3092 20130101; A61F 2002/30578 20130101; A61F
2002/30131 20130101; A61F 2/2846 20130101; A61B 17/8071 20130101;
A61F 2/2803 20130101; A61F 2002/30261 20130101; A61F 2002/30576
20130101; A61F 2/30942 20130101; A61F 2002/30326 20130101; A61F
2002/30072 20130101; A61B 17/8085 20130101; A61F 2002/30537
20130101; A61F 2002/30784 20130101 |
International
Class: |
A61F 2/28 20060101
A61F002/28; A61B 17/80 20060101 A61B017/80; A61F 2/30 20060101
A61F002/30 |
Claims
1. 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.
2. The system of claim 1, wherein the mesh sheet comprises an
overlapping portion connected to the remaining portion of the mesh
sheet via a fourth fold line.
3. The system of claim 1, wherein, when the mesh sheet is folded to
form the three-dimensional graft containment structure, one of a
first end and a second end of the graft containment structure
include an overhang extending beyond one of the folded first and
second end flaps.
4. The system of claim 3, the overhang configured to extend over a
portion of bone to fix the graft containment structure thereto.
5. The system of claim 4, the overhang including an opening
extending therethrough, the opening sized and shaped for receiving
a bone fixation element therethrough.
6. The system of claim 1, wherein the mesh sheet is formed via a
plurality of pores extending therethrough.
7. The system of claim 6, wherein the mesh sheet is formed via a
plurality of intersecting struts, the intersecting struts defining
the plurality of pores.
8. The system of claim 1, wherein first and second longitudinal
edges of the mesh sheet extend along a curve and include
intersecting longitudinal fold lines and lateral fold lines.
9. The system of claim 8, wherein a portion of the lateral fold
lines include a slit extending therealong so that, when folded, the
bone graft containment structure extends along a curve
corresponding to a curvature of a patient's mandible.
10. 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.
11. The system of claim 10, wherein each of the mesh sheets
includes 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.
12. The system of claim 10, wherein a size and shape of each of the
mesh sheets may vary so that a cross-sectional area of the graft
containment structures may vary along a length of the graft
containment assembly.
13. The system of claim 10, wherein one of a first mesh sheet at a
first end of the graft containment assembly and a second mesh sheet
at a second end of the graft containment assembly includes an
overhang so that, when the graft containment assembly is positioned
within the target area, the overhang extends over a portion of the
bone.
14. The system of claim 10, further comprising a bone plate
configured to be positioned over a length of the graft containment
assembly to fix adjacent bone graft containment structured relative
to one another.
15. The system of claim 14, wherein, when the mesh sheets are
folded to form graft containment structures, each of the graft
containment structures include a groove extending therein, the
groove sized and shaped to receive the bone plate.
16. 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.
17. The method of claim 16, wherein maintaining the first graft
containment structure in the closed configuration includes one of
suturing and hooking longitudinal edges of the first graft
containment structure together.
18. The method of claim 16, further comprising folding a second
two-dimensional mesh sheet along fold lines to form a second
three-dimensional graft containment structure, the second 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
second graft containment structure, the first and second mesh
sheets connected to one another along longitudinal edges thereof so
that the first and second graft containment structures are movable
relative to one another.
19. The method of claim 18, further comprising attaching a bone
plate to each of the first and second graft containment structures
and to a portion of bone over which an end of the bone plate
extends.
20. The method of claim 16, further comprising fixing the first
graft containment structure to the bone by inserting a bone
fixation element through an overhang extending from the first graft
containment structure to extend over a portion of bone.
21. The method of claim 16, wherein the first two-dimensional mesh
sheet is designed using a virtual three-dimensional shape based on
a patient's specific bone dimensions.
22. The method of claim 21, wherein the patient's specific bone
dimensions are obtained from a 3D image of the patient's bone.
Description
PRIORITY CLAIM
[0001] 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.
BACKGROUND
[0002] 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.
SUMMARY
[0003] 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.
[0004] 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.
[0005] 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.
BRIEF DESCRIPTION
[0006] FIG. 1 shows a top plan view of a system according to an
exemplary embodiment of the present disclosure;
[0007] FIG. 2 shows a perspective view of the system of FIG. 1;
[0008] FIG. 3 shows another perspective view of the system of FIG.
1;
[0009] FIG. 4 shows a perspective view of the system of FIG. 1, in
a folded configuration;
[0010] FIG. 5 shows a top plan view of a system according to
another exemplary embodiment of the present disclosure;
[0011] FIG. 6 shows a perspective view of the system of FIG. 5, in
a folded configuration;
[0012] FIG. 7 shows a perspective view of a system according to yet
another exemplary embodiment of the present disclosure;
[0013] FIG. 8 shows a perspective view of a mesh sheet according to
the system of FIG. 7;
[0014] 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;
[0015] FIG. 10 shows a perspective view of the system FIG. 7, in a
folded configuration and positioned in the target area of the bone;
and
[0016] FIG. 11 shows a cross-sectional side view of a graft
containment structure according to the system of FIG. 7.
DETAILED DESCRIPTION
[0017] 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.
[0018] As shown in FIGS. 1-4, a system 100 according to an
exemplary embodiment of the present disclosure 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.
[0019] The mesh sheet 102, as shown in FIG. 1, 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.
[0020] In one embodiment, 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. In particular, 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 106a and the second end flap 118 is connected to the
remaining portion 120 via a second one of the fold lines 106b. The
first and second end flaps 116, 118 may be folded along the first
and second fold lines 106a, 106b, respectively, toward the first
surface 122. When folded, 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. In one
example, the first and second end flaps 116, 118 fold to extend
substantially perpendicular to the longitudinal axis of the graft
containment structure 104. As would be understood by those skilled
in the art, 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.
[0021] A third one of the fold lines 106c extends from the first
edge 108 to the second edge 110 and connects the first and second
fold lines 106a, 106b. Thus, upon folding the mesh sheet 102 along
the first and second fold lines 106a, 106b, the mesh sheet 102 may
be folded along the third fold line 106c (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. 4) in which
graft material may be held. As would be understood by those of
skill in the art 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. For example, the graft
containment structure 104 may be closed via suturing and/or
hooking.
[0022] In a further embodiment, 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 106d. When folded along
the fourth fold line, 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.
[0023] 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. In other words, 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.
[0024] 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 the
mesh sheet 102 to achieve a graft containment structure 104 better
suited for the portion of the target bone being treated. For
example, 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
[0025] 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. In one example, the pores may be sized to receive a
fixation screw having a 1.8 mm diameter. In another embodiment, 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.
[0026] According to an exemplary method, the mesh sheet 102 is
configured to be folded along fold lines 106 to form the graft
containment structure 104. In particular, 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. If so desired, 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.
[0027] Once the graft containment structure 104 is in the desired
shape and is packed with graft material, as desired, the graft
containment structure 104 may be placed in a desired positioned in
a recess or gap between two portions of the target bone. For
example, 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. In one
embodiment, 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.
[0028] Although 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.
In one embodiment, 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.
[0029] According to another exemplary embodiment, as shown in FIGS.
5 and 6, 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 206a, 206b to form a graft containment
structure 204. The graft 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 the graft 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. The system 200 may use the mesh sheet 102 of the system
100 as a two-dimensional template for the mesh sheet 202. Using the
desired dimensions of the graft containment structure 204 and the
mesh template, 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 206a,
206b such that, when folded along fold lines 206a, 206b, a graft
containment structure 204 having the desired dimensions is
formed.
[0030] 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 206a, 206b and slits 238 along portions thereof to achieve,
when folded, a desired curvature and shape of the graft containment
structure 204.
[0031] In one embodiment, the mesh sheet 202 is particularly
constructed to treat a patient's mandible. Similarly to the mesh
sheet 102, 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 206a
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 206b so that, when
folded, adjacent portions 240 of the mesh sheet 202, separated from
one another via the laterally extending fold lines 206b, may be
bent relative to one another to achieve the desired curvature of
the graft containment structure 204.
[0032] Similarly to the mesh sheet 102, 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.
[0033] The system 200 may be utilized in substantially the same
manner as described above with respect to the system 100. In
particular, the mesh sheet 202 may be folded along fold lines 206a,
206b 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. As described
above, the graft containment structure 204 will have a desired
size, cross-sectional shape and curvature for treating the target
area of the patient.
[0034] As shown in FIGS. 7-11, a system 300 may be substantially
similar to the systems 100, 200 described above. The system 300,
however, 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. Since the mesh
sheets 302 are connected along the first longitudinal edges 334,
upon folding of the mesh sheets 302, 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. Similarly to the system 200, 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. In particular, 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. 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 of graft containment structures 304.
Alternatively, the 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).
[0035] Each of the mesh sheets 302, as shown in FIG. 8, 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. Similarly to the mesh sheet 102,
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. In particular, 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
306a and a second fold line 306b, respectively. When the mesh sheet
302 is folded, the first and second end flaps 316, 318 may form
first and second ends 312, 314, respectively, of the graft
containment structure 304.
[0036] The mesh sheet 302 may include a third fold line 306c 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. Although 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.
[0037] 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 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). In particular, 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.
[0038] Once each of the mesh sheets 302 have been folded and packed
with grail material, 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. 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 302a and a last
one of the mesh sheets 302b to extend over the separated ends of
the bone when the assembly 301 is positioned therein. As shown in
FIG. 10, 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.
[0039] As shown in FIG. 11, in a further embodiment, 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. In one embodiment,
the grooves 346 may be formed via additional fold lines 306
extending along the mesh sheets 302.
[0040] 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.
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