U.S. patent application number 11/779559 was filed with the patent office on 2009-01-22 for implantable mesh for musculoskeletal trauma, orthopedic reconstruction and soft tissue repair.
Invention is credited to Mark Michels, James D. Ralph, Thomas N. Troxell.
Application Number | 20090024147 11/779559 |
Document ID | / |
Family ID | 40259978 |
Filed Date | 2009-01-22 |
United States Patent
Application |
20090024147 |
Kind Code |
A1 |
Ralph; James D. ; et
al. |
January 22, 2009 |
IMPLANTABLE MESH FOR MUSCULOSKELETAL TRAUMA, ORTHOPEDIC
RECONSTRUCTION AND SOFT TISSUE REPAIR
Abstract
Biocompatible mesh materials are employed to make implants for
repairing or replacing a bone or for soft tissue repair. The mesh
materials can be comprised of bioabsorbable materials,
non-bioabsorbable materials or bioabsorbable and non-bioabsorbable
materials. Pharmaceutical actives, bone growth enhancers and the
like can be combined with the implants.
Inventors: |
Ralph; James D.; (Bethlehem,
PA) ; Troxell; Thomas N.; (Pottstown, PA) ;
Michels; Mark; (Glen Mills, PA) |
Correspondence
Address: |
NORRIS MCLAUGHLIN & MARCUS, P.A.
P O BOX 1018
SOMERVILLE
NJ
08876
US
|
Family ID: |
40259978 |
Appl. No.: |
11/779559 |
Filed: |
July 18, 2007 |
Current U.S.
Class: |
606/151 |
Current CPC
Class: |
A61B 17/8085 20130101;
A61F 2002/30032 20130101; A61F 2002/30062 20130101; A61F 2002/30914
20130101; A61F 2/2846 20130101; A61F 2310/00011 20130101; A61F
2002/30235 20130101; A61F 2210/0004 20130101; A61F 2002/2817
20130101; A61F 2002/30014 20130101; A61F 2002/30915 20130101; A61F
2002/30968 20130101; A61F 2310/00365 20130101; A61F 2/36 20130101;
A61F 2250/003 20130101; A61F 2002/30293 20130101; A61F 2250/0018
20130101; A61F 2002/30909 20130101; A61B 17/8028 20130101; A61F
2002/4495 20130101; A61F 2230/0069 20130101; A61F 2230/0091
20130101 |
Class at
Publication: |
606/151 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Claims
1. An orthopedic implant comprised of a mesh material shaped in the
form of a structure for repairing or replacing a bone or a joint,
the structure having sufficient strength to repair or replace the
bone or joint.
2. The orthopedic implant of claim 1 wherein the mesh material is
comprised of at least two different strand structures having the
same or different compositions.
3. The orthopedic implant of claim 2 wherein said at least two
different strand structures are selected from the group consisting
of monofilament, braided, yarns, threads, hollow tubes, flat
strips, solid ovals, hollow ovals and solid rounds.
4. The orthopedic implant of claim 2 wherein said compositions are
selected from the group consisting of resorbable materials,
non-resorbable materials and resorbable and non-resorbable
materials.
5. The orthopedic implant of claim 1 further comprising at least
one additional mesh material overlaying and adjacent to at least a
portion of the structure.
6. The orthopedic implant of claim 1 wherein the mesh materials are
comprised of strands having interstices therebetween.
7. The orthopedic implant of claim 6 further comprising medication
contained within at least some of the interstices.
8. The orthopedic implant of claim 6 wherein at least some of the
interstices are filled with a biocompatible material.
9. The orthopedic implant of claim 8 further comprising medication
contained within at least some of the interstices.
10. The orthopedic implant of claim 8 further comprising medication
contained within at least some of the biocompatible material.
11. The orthopedic implant of claim 6 wherein at least some of the
strands are tubular strands.
12. The orthopedic implant of claim 11 further comprising
medication within the tubular strands.
13. The orthopedic implant of claim 1 wherein the mesh material is
tubular and has a proximal end and a distal end.
14. The orthopedic implant of claim 13 wherein the mesh material is
woven, braided or knitted.
15. The orthopedic implant of claim 13 comprising at least two
tubular woven mesh materials, each having a proximal end and a
distal end.
16. The orthopedic implant claim 15 wherein said at least two
tubular woven mesh materials are coaxial.
17. The orthopedic implant of claim 16 wherein said at least two
tubular woven mesh materials are coaxially movable relative to one
another.
18. The orthopedic implant of claim 13 wherein one of the proximal
end and/or the distal end is closed.
19. The orthopedic implant of claim 13 wherein the proximal end and
the distal end are open and further comprising an elongate strap
inserted in the proximal open end of the tubular mesh material and
optionally extending through the distal open end, the strap and
mesh material being moveable relative to one another.
20. The orthopedic implant of claim 19 wherein the strap is
comprised of a mesh material.
21. The orthopedic implant of claim 13 wherein the proximal end and
the distal end are open and further comprising an elongate strap
having a first end and a second end, the first end of the elongate
strap being inserted into the proximal open end of the tubular mesh
material and extending through a first opening disposed along a
side portion of the tubular mesh material and the second end of the
elongate strap being inserted into the distal open end of the
tubular mesh material and extending through said first opening or a
second opening disposed along a side portion of the tubular mesh
material.
22. The orthopedic implant of claim 21 wherein the strap is
comprised of a mesh material.
23. The orthopedic implant of claim 21 further comprising a bracket
disposed between the proximal end and the distal end for affixing
the implant to a bone.
24. The orthopedic implant of claim 21 further comprising a
fastener affixed to one end of the elongate strap.
25. The orthopedic implant of claim 13 wherein the tubular mesh
material is flattened.
26. The orthopedic implant of claim 25 further comprising a bone
plate wherein the flattened tubular mesh material is affixed as a
covering over at least a portion of the bone plate.
27. The orthopedic implant of claim 26 wherein the flattened
tubular mesh material is at least partially fused to the bone
plate.
28. The orthopedic implant of claim 1 comprising a bone plate
having a top surface and a bottom surface and a mesh material
laminated to the top surface or the bottom surface or both the top
surface and the bottom surface.
29. The orthopedic implant of claim 1 comprising a first flattened
tubular mesh material, a second flattened tubular mesh material
coaxially disposed within the first flattened tubular mesh material
and a core strip coaxially disposed within the second flattened
tubular mesh material, the core strip comprising a solid or a mesh
material.
30. The orthopedic implant of claim 29 wherein a portion of the
first flattened tubular mesh material is cut away to form a
pocket.
31. The orthopedic implant of claim 1 wherein the mesh material is
comprised of at least one mesh sheet wrapped around an optionally
removable core.
32. The orthopedic implant of claim 31 wherein the core is solid,
tubular or shaped.
33. The orthopedic implant of claim 1 wherein the mesh material is
comprised of at least one rolled mesh sheet.
34. The orthopedic implant of claim 33 wherein the at least one
rolled mesh sheet is pre-cut or pre-shaped.
35. The orthopedic implant of claim 33 wherein the at least one
rolled mesh sheet has a proximal end and a distal end and is rolled
in parallel with an axis.
36. The orthopedic implant of claim 35 which is rolled upon itself
from the proximal end and/or the distal end in a direction along
the axis and perpendicular thereto.
37. The orthopedic implant of claim 33 wherein the mesh material is
diagonally rolled and optionally shaped.
38. The orthopedic implant of claim 33 wherein the mesh material is
pre-cut or pre-shaped.
39. The orthopedic implant of claim 33 wherein the at least one
rolled mesh sheet is shaped by heat, pressure or heat and
pressure.
40. The orthopedic implant of claim 1 having the structure of a
bone plate comprised of a solid material and a mesh material
affixed to the solid material.
41. The orthopedic implant of claim 1 having the structure of a
bone plate comprised of at least one mesh material.
42. The orthopedic implant of claim 1 further comprising at least
one perforation in the mesh material.
43. The orthopedic implant of claim 1 comprising at least two
sheets of the mesh material.
44. The orthopedic implant of claim 43 wherein said at least two
sheets are the same or different.
45. The orthopedic implant of claim 44 wherein said at least two
sheets are adhered to one another.
46. The orthopedic implant of claim 44 wherein said at least two
sheets have a common perimeter and said at least two sheets are
adhered to one another at the perimeter.
47. The orthopedic implant of claim 44 wherein said at least two
sheets are adhered to one another at discreet points of
contact.
48. The orthopedic implant of claim 44 wherein the mesh materials
are comprised of strands having interstices therebetween and at
least some of the interstices are filled with a biocompatible
material or medication or a biocompatible material and
medication.
49. An implant device comprising a mesh material shaped in the form
of a structure for orthopedic, musculoskeletal or soft tissue
repair, the mesh material having multiple strands, the strands
crossing each other at points of contact with one another wherein
at least some of the strands are affixed to others at the points of
contact.
50. The implant device of claim 49 wherein some of the strands are
affixed to others by adhesive, fusion or knots.
51. The implant device of claim 49 wherein the mesh material is
compacted.
52. The implant device of claim 49 comprised of more than one mesh
material.
53. The implant device of claim 52 wherein at least one mesh
material is compacted.
54. The implant device of claim 49 wherein the mesh material is
comprised of one or more than one higher melting point strand and
one or more than one lower melting point strand, at least the lower
melting point strand or strands having at least one point of
contact and said lower melting point strand or strands is fused at
each point of contact.
55. A method of making an implant device comprising a mesh material
shaped in the form of a structure for orthopedic, musculoskeletal
or soft tissue repair comprising affixing to one another at points
of contact with one another strands of a mesh material having
multiple strands, the strands crossing each other at points of
contact with one another.
56. The method of claim 55 wherein the implant device is comprised
of more than one mesh material.
57. An implant device comprising a mesh material shaped in the form
of a structure for orthopedic, musculoskeletal or soft tissue
repair, the mesh having multiple strands and interstices between
the strands, at least some of the interstices being filled with a
biocompatible material or medication or a biocompatible material
and medication.
58. The implant device of claim 57 comprised of more than one mesh
material.
59. A method of making an implant device comprising a mesh material
shaped in the form of a structure for orthopedic, musculoskeletal
or soft tissue repair comprising filling with a biocompatible
material or medication or a biocompatible material and medication
at least some interstices in a mesh having multiple strands and
interstices between the strands.
60. The method of claim 59 wherein the implant device is comprised
of more than one mesh material.
61. An orthopedic implant device comprising a rolled up or
compacted mesh material shaped in the form of a structure for
repairing or replacing a bone or a joint.
62. The orthopedic implant device of claim 61 wherein the rolled up
or compacted mesh material is overlayed with one or more layers of
a mesh material which is the same as or different from the rolled
up or compacted mesh material.
63. The orthopedic implant device of claim 61 wherein the mesh
material is a filled mesh material.
64. A method of contouring the orthopedic implant device of claim
61 comprising heating the device and reshaping it to a new contour
that fits a patient's anatomy wherein the device maintains the new
contour upon cooling.
65. An implant device comprising a mesh material for orthopedic,
musculoskeletal or soft tissue repair, the mesh material having a
flat central section with two opposing ends, the flat central
section tapering at each opposing end to a cable, rope or strap
comprised of the mesh material.
66. A method of making an implant device comprising a rolled up or
compacted mesh material shaped in the form of a structure for
repairing or replacing a bone or a joint comprising rolling up a
mesh material to make a rolled-up perform or compacting a mesh
material to make a compacted preform and subjecting the rolled-up
or compacted preform to heat and/or pressure in order to shape it
into the implant device.
67. The method of claim 66 wherein the mesh material is a filled
mesh material.
68. An orthopedic implant device comprising a core wrapped with
multiple layers of a mesh material and shaped in the form of a
structure for repairing or replacing a bone or a joint.
69. A method of making an implant device comprising a mesh material
shaped in the form of a structure for repairing or replacing a bone
or a joint comprising wrapping a core with multiple layers of a
mesh material to make a wrapped core and subjecting the wrapped
core to heat and/or pressure in order to shape it into the implant
device.
70. A method of contouring an orthopedic implant device having a
contour that can be reshaped upon heating and being comprised of a
mesh material or mesh materials, optionally in combination with
non-mesh materials, comprising heating the device and shaping it to
a new contour that fits a patient's anatomy wherein the device
maintains the new contour upon cooling.
71. The orthopedic implant of claim 45 wherein the mesh materials
are comprised of strands having interstices therebetween and at
least some of the interstices are filled with a biocompatible
material or medication or a biocompatible material and
medication.
72. The orthopedic implant of claim 46 wherein the mesh materials
are comprised of strands having interstices therebetween and at
least some of the interstices are filled with a biocompatible
material or medication or a biocompatible material and
medication.
73. The orthopedic implant of claim 47 wherein the mesh materials
are comprised of strands having interstices therebetween and at
least some of the interstices are filled with a biocompatible
material or medication or a biocompatible material and medication.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to biocompatible mesh
materials that are formed into implantable structures for treatment
of musculoskeletal trauma, orthopedic reconstruction and soft
tissue applications.
[0003] 2. The Related Art
[0004] Biocompatible mesh materials have traditionally been used in
soft tissue surgery. But these materials have been largely ignored
for skeletal repair, due in part to their flexibility and lack of
strength. For example, U.S. Pat. No. 3,463,158 describes
polyglycolic acid materials which are used to make absorbable and
partially absorbable woven devices which are said to be useful in
the repair of hernias, arteries and veins.
[0005] More rigid hardware devices made from fenestrated shells are
described in U.S. Patent Application Pub. No. 2005/0015154. These
devices are said to enhance tissue integration so that the device
becomes permanently affixed to the tissue.
[0006] There are many musculoskeletal trauma and orthopedic
reconstruction needs that are not effectively met by current
technology either because the materials of construction are too
rigid or too flexible for their designated applications. The
devices of the present invention provide a significant improvement
over the current technology by employing mesh materials in a
non-traditional manner and/or by employing certain new mesh
materials and modified mesh materials in medical applications.
SUMMARY OF THE INVENTION
[0007] The implantable devices of the present invention employ
meshes comprised of bioabsorbable materials or non-bioabsorbable
materials or a combination of bioabsorbable and non-bioabsorbable
materials. Each device is made in the form of a structure having
the strength and other physical characteristics necessary to carry
out its intended purpose. The meshes can be employed alone to form
implantable devices or they can be combined with other and
different meshes and/or non-mesh materials to form implantable
devices. The devices also can be combined with pharmaceutical
agents, bone growth enhancers and the like.
[0008] Mesh materials, which can be used in the present invention,
can take numerous forms. They can be woven, knitted, braided or
knotted, or an arrangement of interlocking links (such as the links
of the type found in jewelry or chain link fencing) or other
interlocking, intertwined or interwoven constructions and the terms
"mesh" or "mesh materials" as used herein are intended to include
these various forms and constructions.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The figures illustrate mesh materials employed in the
invention and embodiments of the invention employing the mesh
materials. The figures may not be drawn to scale.
[0010] FIG. 1 illustrates a simple implantable mesh.
[0011] FIG. 2 illustrates the type of mesh shown in FIG. 1 in a
more dense weave with smaller voids.
[0012] FIG. 3 illustrates a mesh with variable spacing between
strands.
[0013] FIG. 4 illustrates a loosely woven mesh having alternating
pairs of strands in each direction.
[0014] FIG. 5 illustrates a mesh wherein the strands are not
parallel to the edges of the sheet.
[0015] FIG. 6 illustrates a mesh with alternating pairs of
strands.
[0016] FIG. 7 illustrates a mesh having different strands in
different dimensions.
[0017] FIG. 8 illustrates a mesh with solid oval strands in one
direction and hollow round strands in the other.
[0018] FIGS. 9A and 9B illustrate meshes which are knitted.
[0019] FIG. 9C illustrates a braided mesh.
[0020] FIG. 9D illustrates a tubular braided mesh.
[0021] FIG. 9E illustrates a mesh in an interlocking link
configuration.
[0022] FIG. 9F illustrates a knotted mesh.
[0023] FIG. 10 illustrates a mesh between two heated platens.
[0024] FIG. 10A illustrates a mesh with strands of different
materials between two heated platens.
[0025] FIG. 11 illustrates a filled mesh.
[0026] FIG. 12 illustrates two different meshes laminated
together.
[0027] FIG. 12A illustrates two different meshes layered one on the
other and having filled or sintered edges.
[0028] FIG. 12B illustrates a mesh having a variable shape.
[0029] FIG. 13 and FIG. 13A illustrate tubular forms of meshes.
[0030] FIGS. 13B-1, 13B-2 and 13B-3 illustrate tubular forms of
woven meshes which have been rolled upon themselves.
[0031] FIG. 14 illustrates a flattened tubular mesh.
[0032] FIG. 14A illustrates a section of tubular mesh to be sealed
at one or both ends.
[0033] FIGS. 14B-1 and 14B-2 illustrate a multi-component flattened
tubular mesh construct.
[0034] FIGS. 14B-3 and 14B4 illustrate a resected rib segment which
is repaired using flattened tubular mesh.
[0035] FIG. 14C illustrates a flattened tubular mesh with a movable
member and a means of affixing the member relative to the mesh.
[0036] FIG. 14D-1 and 14D-2 illustrate an inner mesh member formed
into a loop and adjusted through a tubular mesh member.
[0037] FIG. 14D-3 illustrates a mesh strap with a fastener affixed
to one end.
[0038] FIGS. 14E-1 and 14E-2 illustrate flattened tubular mesh
covering a bone plate.
[0039] FIGS. 14E-3, 14E4 and 14E-5 illustrate bone plates having
mesh material laminated thereon;
[0040] FIGS. 15 and 15A illustrate rolled mesh tubes with and
without a core.
[0041] FIG. 16 illustrates a diagonally rolled mesh.
[0042] FIG. 16A illustrates a rolled pre-shaped mesh sheet.
[0043] FIGS. 16B-1, B-2, B-3 and B-4 illustrate a sequence using a
rolled pre-shaped mesh sheet to make a hip stem.
[0044] FIGS. 16C-1, C-2, C-3 and C-4 illustrate the use of mesh and
a core member to make a hip stem.
[0045] FIG. 17 illustrates the structure of a compressed sintered
mesh.
[0046] FIG. 18 illustrates cancellous bone of the femur.
[0047] FIG. 19 illustrates a bone plate with a mesh central
section.
[0048] FIG. 20 illustrates a woven mesh that has been fused and
perforated.
DETAILED DESCRIPTION OF THE INVENTION
[0049] The invention has to do with implantable devices made from
mesh materials. One or more than one type of mesh material can be
used in an implantable device of the invention. And the mesh
material can be combined with non-mesh materials such as rods,
tubes, solid sheets, perforated sheets, fillers and other materials
of various shapes, forms and compositions to make a composite
implant structure having sufficient strength to carry out its
intended purpose. The implantable devices of the invention can be
used to repair or replace a bone or a joint or reattach a tendon,
muscle or cartilage. Novel mesh structures for soft tissue repair
are also described.
[0050] In the simplest structure, a woven implantable mesh consists
of two sets of strands crossed over and under each other in a
simple alternating pattern as shown in FIG. 1. Strands 1 are
approximately perpendicular to strands 2 and they intersect at
points of contact 3.
[0051] Many other woven mesh configurations are possible, however.
Decreasing the spacing between the strands can produce a denser,
less permeable mesh with smaller voids 4 as shown in FIG. 2. These
voids can be precisely tailored either to encourage or discourage
hard or soft tissue ingrowth.
[0052] The mesh can also be woven with a variable spacing between
strands. This can occur along one axis or along both as shown in
FIG. 3 wherein strands 5 and strands 6 are closely spaced along
both axes as compared with strands 7 and strands 8. This concept is
subject to numerous variations as will be apparent to those having
skill in the art.
[0053] A loosely woven mesh can be created by alternating pairs of
strands in each direction as shown in FIG. 4 where strand pair 10
alternates with strand pair 12 along one axis and strand pair 11
alternates with strand pair 13 along another axis. Variations of
this include double strands along only one axis and one strand or
numbers of strands greater than two in any direction.
[0054] All of the above examples show the strands essentially
parallel to the edges of the sheet of mesh, but this too can be
varied as shown in FIG. 5 wherein all of the strands 14 and 15 are
not parallel to the edges of the sheet of mesh 16.
[0055] By varying the fibers or strands in each direction, the
material properties can be changed uniformly as shown in FIG. 6 or
distinctly different directional properties can be created as shown
in FIG. 7. In mesh 9 of FIG. 6, relatively stiff strands 17 are
alternated with relatively flexible strands 18 along one axis and
strands of one material 19 are alternated with strands of another
material 20 along the other axis. In FIG. 7, relatively stiff
strands 21 are along one axis and flexible strands 22 are along the
other. These various configurations can be used to vary physical
properties of the mesh material, such as directions of bending and
strength, as well as other properties such as by alternating
bioabsorable and non-bioabsorbable materials.
[0056] FIGS. 1-7 show essentially round strands but they could also
be flattened strips or intermediate shapes such as ovals. FIG. 8
shows a mesh with solid oval strands 23 in one direction and hollow
round strands 24 in the other.
[0057] Numerous other constructions can be used to make the mesh
materials of the present invention as will be apparent to those
skilled in the art based upon the disclosures herein. Some examples
are provided in FIGS. 9A-9F. FIGS. 9A and 9B illustrate different
types of knitted mesh. In FIG. 9A, strands 121 and 122 are
illustrated in a weft-knitted construction. FIG. 9B illustrates a
warp-knitted construction with strands 123 and 124. FIG. 9C shows a
braided mesh using flat strands 125 and 126. Of course, tubular
braided mesh can be made, for example, following the construction
of the braided shield for coaxial cable as illustrated in FIG. 9D.
FIG. 9E illustrates a mesh having an interlocking link
configuration using strands 127. A knotted mesh with strands 128 is
illustrated in FIG. 9F.
[0058] The strand materials can come from any of the classes of
biocompatible implant materials; metallics, bioresorbable polymers
and non-resorbable polymers. In addition, organic materials such as
collagen are suitable in some applications. The strands can have
various physical structures. For example, they can be monofilament
or thread or yarn structures. They can be braided or they can be
hollow tubular structures and the hollow tubular structures can
have a cross-section which is round, oval, square, rectangular,
triangular or of any other closed geometric shape, including
irregular shapes. If the hollow strands are porous or
biodegradable, they can be filled with medication or bone growth
substances to provide a timed release at the surgical site. A
surgical mesh which incorporates a timed release of antibiotics is
particularly attractive in abdominal wall or hernia repair.
[0059] Many of the previous examples show a woven mesh in a flat
configuration but this is just the starting point for mesh
implants. In a flat woven configuration, the individual strands can
shift relative to each other to provide maximum flexibility. In
other applications it might be desirable to constrain the strands
to create a more rigid construction. This can be accomplished in
several ways. One method is to sinter the woven mesh. Sintering is
the process of fusing adjacent structures by heating them just
below the melting point of the material. At this temperature the
strands will soften and fuse together where they contact one
another. Pressure may be used in addition to heat alone. FIG. 10
illustrates a basic mesh 30, as illustrated in FIG. 1, between two
heated platens 25 and 26. Because the strands are of the same
material in both directions, the resulting mesh will be fused at
each point of contact where the strands cross one another (i.e., at
the intersections). Of course, adhesives, knots or other means
known to those having skill in the art can be used to adhere the
strands to one another at points of contact.
[0060] If this same process is applied to mesh 9 shown in FIG. 6,
where the alternating strands in both directions are of different
materials, the resulting mesh will have different characteristics.
If strands 18 and 20 have a lower melting point than strands 17 and
19, then heating the platens to just below the strands 18 and 20
melting point will cause only the strands 18 and 20 to fuse to one
another at their intersections. The strands 17 and 19 will remain
mobile relative to one another and relative to the strands 18 and
20. FIG. 10A illustrates this concept. Variations on this concept
would include a mesh material wherein most of the strands have a
lower melting point than the others or wherein most of the strands
have a higher melting point than the others. The lower melting
point strands can be dispersed evenly, unevenly or in a specific
woven pattern. One lower melting point strand or one higher melting
point strand could be woven in a manner that would cause it to have
one or more than one point of contact with itself, such as a woven
loop. Thus, a sintered mesh material according to the invention
could comprise higher melting point strands and at least one lower
melting point strand having one or more than one point of contact
with itself or two or more than two lower melting point strands
having at least one of point of contact wherein the lower melting
point strand or strands are sintered, and therefore affixed, at the
point or points of contact.
[0061] Another method of constraining the strands in a mesh is to
fill the interstices between the strands with another biocompatible
material thereby locking the strands in their relative positions.
This also serves to combine the properties of the mesh material and
the filler. In this manner, the mesh structure can act as a
reinforcing element for the filler resulting in a composite
material having properties superior to either material alone.
Suitable filling materials include resorbable polymers, hydrogels,
collagen as well as non-resorbable polymers. If this material is
bioresorbable, then the gradual degradation of the bioresorbable
component will alter the overall mechanical properties of the
filled mesh over time. If the filling material is non-resorbable,
then the mechanical properties will remain unchanged after
implantation. A filling material that softens at a relatively low
temperature (like most bioresorbable polymers) also provides the
advantage of allowing the mesh to be shaped intraoperatively. In
surgery, it is often necessary to contour an implant to match the
patient's anatomy and have the implant maintain the new contour
while providing support to the tissue. Most polymer based meshes
can be contoured but have the tendency to spring back to their
original shape. Filling the mesh with a material that softens at a
low temperature allows the implant to be heated in the operating
room, contoured to fit the patient and then, after cooling, it
maintains that form because the filler locks the strands in their
new positions. FIG. 11 illustrates a filled woven mesh comprised of
strands 27, strands 28 and filling material 29. This feature of
intraoperatively reshaping an implant device is applicable to all
of the embodiments of the invention wherein the materials used to
make the implant (e.g., a mesh material, a combination of mesh
materials or a combination of mesh material and non-mesh material)
can be reshaped upon heating to a new contour that fits a patent's
anatomy and the implant device maintains the new contour upon
cooling.
[0062] Implantable meshes can also be comprised of at least two
sheets of mesh optionally adhered to one another, for example,
laminated together or adhered to one another at predetermined
discreet points of contact such as at points 32a and 32b in FIG.
12. The layers in a laminated construction can be multiple layers
of the same mesh or they can be comprised of layers of different
mesh materials. In addition, the orientation of the strands can
remain constant or be varied from layer to layer. FIG. 12
illustrates one possible configuration where only two layers are
shown for clarity, the layers being comprised of the mesh 30 of
FIG. 1 and the mesh 31 of FIG. 8. Just as with a single layer of
mesh, it is possible to sinter the mesh layers together (at
predetermined discreet points of contact or at all points of
contact) and/or fill them with another material.
[0063] In another embodiment, a multilayer construction can have
only the edges (i.e., the perimeter) sintered, filled or both. The
center section remains flexible. An example is shown in FIG. 12A
wherein a filling material 32 is applied around the edges of
layered meshes 33 and 34 to make a layered mesh composite 35.
[0064] Implantable mesh products can be produced in shapes other
than flat sheets. FIG. 12B depicts a flat central section 36 which
then tapers to a smaller, cable-like cross section 37 at each end
(i.e., the opposing ends). The cable-like cross-section can also be
described as a rope or strap and this portion of the device is made
from the same material as the mesh material. Such a construct may
be attached to a needle and sutured around bone or soft tissue to
provide a larger area of support where required.
[0065] Mesh may be fabricated in tubular form by weaving, knitting
or braiding processes. (See FIGS. 9A-9D.) As with flat mesh
materials, these tubular structures can incorporate multiple strand
materials, process variations which produce a wide range of
densities and strengths as well as three dimensional
configurations. Rounds (FIG. 13 illustrating woven round tubular
mesh 38), ovals and flattened tubular forms (FIG. 14 illustrating
woven, flattened tubular mesh 44) are but a few examples and others
will be apparent to those having skill in the art. These forms of
mesh can also be sintered, filled or the like as previously
described. One or more than one form may be inserted within the
hollow core of another as illustrated in FIG. 13A which depicts a
coaxial arrangement of cylindrical mesh tubes 38 and 39. Tubular
mesh structures can also be combined with rolled and compacted mesh
structures in various configurations as will be apparent to those
skilled in the art based on the disclosures herein. A cylindrical
mesh tube can also be rolled down upon itself to form a ring-like
structure 40 or 41 as shown in FIGS. 13B-1 and 13B-2, respectively.
It too can be rolled around an optional core element as shown in
the section view 13B-3 illustrating core element 42 and mesh
43.
[0066] Flattened tubular mesh could be made by weaving, braiding or
knitting to produce a flat, hollow cable or strap which
additionally can be combined with many other components to form
implantable medical devices. FIG. 14 shows a flattened tubular mesh
44 in its simplest form.
[0067] A section of mesh 44, sealed at one end can form a packet
for containing medication and this can be used in the manner
described in U.S. Pat. No. 6,916,483. The mesh structure permits
body fluids to act upon the contents yet will contain them in a
volume for implantation at a desired location in the body or in
another implant. FIG. 14A illustrates this concept. The open end
can be sealed intraoperatively using heat, adhesives, sutures or
the like. Heating elements 45 and 46 are illustrated. These are
moved in the directions of arrows 45A and 46A to seal one end 47.
In an alternate embodiment both ends 47 and 48 can be sealed before
implantation in a patient.
[0068] FIGS. 14B-1 and 14B-2 illustrate a multi-component flattened
tubular mesh construct. Outer layer 50 and intermediate layer 51
are flattened tubular mesh with a core strip 52 comprising a solid
material or mesh. These components can be selected to provide
strength, stiffness, a targeted resorption profile, tissue ingrowth
properties, etc. In a variation of this embodiment, one end of the
outer member is partially cut away; the other forms a flattened
tubular pocket. Such a construct can be slipped over the end of a
segmentally resected rib, seating the rib in the pocket. This
concept can also be applied to any fractured or incised bone.
Alternatively, an open end of the flattened tubular mesh can be
slipped over the end of the segmentally resected rib. The opposite
end can then be secured to the other end of the rib segment thereby
bridging the resection and restoring continuity to the chest wall.
In another variation, if the resected rib segment or an allograft
is available, either of these may be inserted into just the outer
member to achieve fusion as well. Accordingly, an example of an
orthopedic implant is described which is comprised of a mesh
material shaped in the form of a structure for repairing a bone.
This is illustrated in FIGS. 14B-3 and 14B4 where sleeves 55 and 56
are slipped over each end of the resected rib segment 57. This can
be reimplanted into the chest wall defect to achieve fusion.
[0069] In a multi-component tubular mesh construction, the members
can also be designed to be moveable relative to one another as
shown in FIGS. 14C through 14D-3. FIG. 14C illustrates an outer
flattened tubular member 60 which can be fixed in position. The
inner mesh strap 61 can be attached to tissue (hard or soft) and
slid into or out of the outer member 60 which can be fixed by
various means, for example, bracket 62, thereby moving one tissue
fixation point relative to the other. FIGS. 14D-1 and 14D-2 depict
an inner mesh member 64 (cable or flat mesh) formed into a loop.
Each end of this inner member is inserted through an opposite end
of a flattened tubular mesh member 65 and then exits through
lateral slots 66 and 67. Either or both ends of the inner member 64
can then be pulled through the outer member 65 to decrease the size
of the inner loop. FIG. 14D-3 illustrates a single mesh strap 68
with a fastener 69 on one end. The free end of the mesh strap 68 is
inserted through the slot in the fastener forming a loop, and by
pulling on this end, the loop can be tightened.
[0070] Flattened tubular mesh can also be used as an outer covering
for a bone plate. The addition of this outer mesh cover can add
strength, stiffness, tissue ingrowth properties, the ability to
deliver medication, etc. FIGS. 14E-1 and 14E-2 illustrate this
embodiment. These figures show the mesh 70 being perforated after
being drawn over the bone plate structure 71 to expose the fastener
holes 72. This perforation process can be performed with a heated
punch to fuse, at least partially, the mesh to the plate and/or to
fuse the edges of the holes to the mesh 70. The bone plate
structure 71 can be comprised of a solid material or it can be
comprised of mesh material which is the same as or different from
mesh 70. For example, the bone plate structure 71 can be a filled
and/or laminated mesh, a sintered mesh, a mesh strap or other mesh
of the types described herein. It could also be a solid metal or
plastic or a combination thereof or a combination of solid material
and mesh material (e.g., a laminate) and it could be comprised of a
resorbable, non-resorbable or a combination of resorbable and
non-resorbable materials.
[0071] Other bone plate embodiments are illustrated in FIGS. 14E-3,
E4 and E-5. Each figure illustrates a section view of bone plate
structure 71. In FIG. 14E-3, mesh material 73 is laminated to the
top surface of bone plate structure 71. In FIG. 14E4, mesh material
74 is laminated to the bottom surface of bone plate structure 71.
And in FIG. 14E-5, mesh material 73 is laminated to the top surface
and mesh material 74 is laminated to the bottom surface of bone
plate structure 71.
[0072] Tubular mesh structures may also be created by rolling up
sheets of mesh. These can be single sheets, laminated sheets,
sintered sheets or filled sheets or any combination thereof. A
shaped core can be used in the process and this core may become
part of the implant or may only be used for a portion of the
fabrication process. This core can be solid, tubular or shaped, and
it can be comprised of any implant materials known in the art. The
core can be a composite of various implant materials and it may
also take the form of a partial core if required. It is also
possible to roll the mesh sheets with no core. Afterwards the
rolled construct can be formed into a final cross-sectional shape
using heat and/or pressure, adhesives, filling material, any
flowable material that can be hardened by curing, etc. The
orientation of the mesh strands relative to the rolling direction
can be varied to produce different mechanical properties of the
finished tubular form. Similarly, the orientation of the rolling
direction relative to the edge of the sheet can greatly influence
the mechanical properties of the finished tubular form. FIG. 15
illustrates a tube 75 rolled parallel to one of the strand
directions and parallel to the edge of the mesh sheet. In the
finished form, the mechanical properties will be uniform over the
length of the tube. FIG. 15A shows a mesh sheet 76 rolled around a
core 77.
[0073] FIG. 16 illustrates a mesh 80 rolled diagonally with respect
to the edges of the sheet 81 and 82. When rolling is complete, a
tube will be formed and the middle of the tube will have the
greatest number of mesh layers. This number will steadily decrease
as one moves from the middle toward either end of the tube. In this
way, a variable stiffness mesh tube may be created. The ends of the
tube can be cut square if desired. Furthermore the tube can be
sectioned at any point to create the desired properties at an end.
Obviously this concept can be carried further by shaping the mesh
sheet prior to rolling. In a simple embodiment of this concept,
consider FIG. 16A. The sheet of mesh 86 in this case is essentially
the full sheet from FIG. 16, cut diagonally with one corner
truncated. When this shaped sheet is rolled, the result will be a
tubular member with a stiffness that decreases from edge 87 to edge
88.
[0074] FIGS. 16B through 16E illustrate the use of a rolled,
pre-shaped sheet as part of a larger process to produce a more
complex shape. The process starts with a pre-cut or pre-shaped
sheet of mesh 90 that is rolled lengthwise (FIG. 16B-1) in the
direction of arrow 91. The result is a wrapped preform 92 with an
axis of symmetry 93 (FIG. 16B-2). This preform is then placed
between two platens 94 and 95 (FIG. 16B-3). Each platen has a
cavity conforming to half of the final shape of the implant. Heat
and/or pressure is used to compress and/or sinter the preform to
the desired final shape--in this case a hip stem 96 (FIG. 16B4).
Because this final shape is rigid, it can be machined subsequently
if required. Accordingly, an example of an orthopedic implant is
described which is comprised of a mesh material shaped in the form
of a structure (a prosthesis) for replacing a bone and/or a
joint.
[0075] FIGS. 16C-1 through 16C4 depict a different use of mesh to
form a complex implant shape--in this case another hip stem. In
this embodiment, a core comprised of a main shaft 100 and arm 101
is wrapped by a mesh strip 102 (FIG. 16C-1). This process proceeds
much as one would tape an ankle or wrist, until the desired
intermediate shape 103 is achieved (FIG. 16C-2). As in the previous
example, the intermediate shape 103 is pressed between two shaped
platens 104 and 105 (FIG. 16C-3) to achieve the final implant 106
(FIG. 16C4).
[0076] More complex three-dimensional shapes can be formed by
compacting the implantable mesh, similar to wadding up a piece of
paper to throw in the trash. This can be done with single sheets,
laminated sheets, rolled sheets, sintered sheets or filled sheets
of mesh, or any combination thereof. Once the mesh is compacted
into the desired shape, it can be locked in place by sintering
and/or filling the strands. While a hip stem is illustrated,
obviously this process could be used to produce a wide range of
implants including bone plates, screws, rods, etc. The resulting
three-dimensional structure of a compressed, sintered mesh (FIG.
17) is quite similar to that of cancellous bone (FIG. 18).
Additionally, it is possible to coat this three dimensional mesh
structure with other implant materials to provide an outer layer
which is not mesh based.
[0077] Implantable mesh can be combined with other components to
form a complete implant. FIG. 19 illustrates a bone plate 110 with
a mesh central section 111, solid ends 112 for attachment to the
bone and optional sides 113. Bone plate 110 can be manufactured by,
for example, cutting a piece of mesh to approximately the shape and
size of bone plate 110, filling the ends and side with a curable,
flowable filling material and then curing the filling material. An
alternative embodiment could be made without sides 113. Moreover,
the ends and/or sides of bone plate 110 can be made of a material
which softens on heating so that it can be conformed to the shape
of the operating site of the patient. Then it would harden and
retain its shape at body temperature. If the central section was
filled with a bioresorbable material (not shown), it would
initially be stiff but then would gradually transfer the mechanical
load to the bone as the bioresorbable material degrades. The result
would be an implant of reduced residual mass that would prevent
stress shielding. The addition of bioresorbable filling material
would also allow the implant to be heated to the softening point of
the bioresorbable material for intraoperative contouring of the
implant to the bone surface.
[0078] The mesh material also can be perforated. The perforation
process can be combined with heat to fuse the perforated edges to
prevent fraying or loosening of the fibers or strands. FIG. 20
illustrates this concept.
[0079] Mesh structures provide a means of producing surgical and
orthopedic implants with enhanced properties. They represent a
method of combining a wide range of existing implant materials in
new ways to maximize their advantages and minimize their individual
limitations. Strands of various materials can be interwoven at the
mesh level. Various fabrication methods (e.g., weaving, knitting,
braiding and perforating) can create mesh with a wide range of
physical properties. Layers of different mesh can be laminated
together to produce a hybrid implant material with properties
precisely tailored to the clinical indication. These mesh
structures can be further reinforced by sintering the strands to
prevent movement and/or by encapsulating them in another material.
In this manner, an implant can be made with properties not found in
the current selection of biomaterials. Implants for fracture
fixation could be made with the required initial strength but also
with the ability to partially or completely resorb preventing
stress shielding, minimizing the amount of residual foreign
material in the patient and reducing the number of second (removal)
surgeries. Reconstructive implants could be made with internal
structures similar to cancellous bone, thus offering a better
combination of strength, resiliency and reduced weight. Surgical
meshes for muscle, ligament or tendon repair and/or reattachment to
bone can be wholly or partially resorbable and offer the ability to
deliver antibiotics or other medications to the local surgical
site. The exposed surfaces of implants could be designed either to
encourage or discourage the ingrowth of hard or soft tissues. The
net result is a new class of biomaterials with enhanced mechanical
and biological properties.
* * * * *