U.S. patent application number 14/854387 was filed with the patent office on 2016-01-07 for composite metal and bone orthopedic fixation devices.
This patent application is currently assigned to STC.UNM. The applicant listed for this patent is STC.UNM. Invention is credited to Paul E. Kaloostian.
Application Number | 20160000489 14/854387 |
Document ID | / |
Family ID | 54352564 |
Filed Date | 2016-01-07 |
United States Patent
Application |
20160000489 |
Kind Code |
A1 |
Kaloostian; Paul E. |
January 7, 2016 |
Composite Metal and Bone Orthopedic Fixation Devices
Abstract
Composite orthopedic devices that facilitate spine
stabilization, such as: bone screws, rods, plates, interbodies, and
corpectomy cages are disclosed. They are designed to provide both
strength and load carrying capabilities, while increasing
bio-integration of the devices with the surrounding bone tissue.
They are constructed of composite layers of allograft and/or
autograft bone and a structural material, such as titanium alloy or
carbon/graphite fiber composite. Cannulations within the device are
loaded with a mixture of stem cells, particles of allograft and/or
autograft bone, and bone growth factors, such as BMP-2. The
cannulations are connected to the surface of the device via
multiple fenestrations that provide pathways to supply the
bone/stem cell mixture to the surface, allowing living bone tissue
to grow and insure bio-integration. The devices can also have
radiofrequency (RF) stimulation implantation within the structure
of the implanted device, capable of responding to external RF
stimulation of enhanced bone growth.
Inventors: |
Kaloostian; Paul E.; (Los
Angeles, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
STC.UNM |
Albuquerque |
NM |
US |
|
|
Assignee: |
STC.UNM
Albuquerque
NM
|
Family ID: |
54352564 |
Appl. No.: |
14/854387 |
Filed: |
September 15, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13918949 |
Jun 15, 2013 |
9173692 |
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14854387 |
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61660107 |
Jun 15, 2012 |
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61660133 |
Jun 15, 2012 |
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Current U.S.
Class: |
606/323 |
Current CPC
Class: |
A61B 17/866 20130101;
A61F 2002/2835 20130101; A61F 2002/30784 20130101; A61F 2310/00958
20130101; A61B 17/8605 20130101; A61F 2310/00359 20130101; A61B
17/8625 20130101; A61B 17/7002 20130101; A61B 2017/00964 20130101;
A61F 2310/00023 20130101; A61B 17/68 20130101; A61F 2/44 20130101;
A61F 2310/0097 20130101; A61B 17/7035 20130101; A61B 17/80
20130101; A61F 2002/30787 20130101; A61B 17/7037 20130101; A61B
2017/00933 20130101; A61B 17/702 20130101; A61B 17/8615 20130101;
A61B 17/8841 20130101; A61F 2002/3055 20130101; A61F 2002/30601
20130101; A61B 17/8685 20130101; A61F 2002/30405 20130101; A61B
17/864 20130101; A61B 17/7098 20130101 |
International
Class: |
A61B 17/86 20060101
A61B017/86; A61B 17/70 20060101 A61B017/70 |
Claims
1-11. (canceled)
12. A composite orthopedic rod for use in a surgical procedure
comprising a shaft having a first end and a second end wherein the
shaft defines a cannulation extending along at least a portion of
the length of the shaft; wherein the cannulated portion of the
shaft contains at least one fenestration, wherein the rod is
constructed of a material comprising allograft and/or autograft
bone and a metal or metal alloy.
13. The rod according to claim 15, wherein the rod is constructed
of a material comprising a core and two layers; wherein the core is
allograft and/or autograft bone, the middle layer is a metal or
metal alloy, and the outermost layer is allograft and/or autograft
bone.
14. The rod according to claim 15, wherein the rod is constructed
of a material comprising about 50% allograft and/or autograft bone
and about 50% metal or metal alloy.
15. The rod according to claim 15, wherein the metal or metal alloy
is selected from the group consisting of titanium, cobalt-chromium,
niobium alloy, and tantalum alloy.
16. The rod according to claim 15, wherein the rod is coated with
an antibiotic solution.
17. The rod according to claim 15, wherein the cannulated portion
of the shaft is filled with stem cells and allograft and/or
autograft bone.
18. The rod according to claim 15, wherein the titanium or metal
products is replaced with carbon fiber product in exact ratio as
described above with the titanium embodiment.
19. The rod according to claim 15, further comprising
radiofrequency stimulation implantation within the structure of the
rod, capable of responding to external stimulation.
20. A composite orthopedic rod for use in a surgical procedure
comprising a shaft having a first end and a second end wherein the
shaft defines a cannulation extending along at least a portion of
the length of the shaft; wherein the cannulated portion of the
shaft contains at least one fenestration; and wherein the rod is
constructed entirely of a carbon or graphite fiber reinforced
composite material that essentially contains no metal or metal
alloy.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of US Provisional Patent
Application by Paul E. Kaloostian, Ser. No. 61/660,133, "Device for
Guiding and/or Forming a Hole in Bone Tissue and Methods of Use",
filed Jun. 15, 2012; and also US Provisional Patent Application by
Paul E. Kaloostian, Ser. No. 61/660,107, "Orthopedic Devices and
Methods of Use", filed Jun. 15, 2012; both of which are
incorporated herein by reference.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not Applicable.
THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT
[0003] Not Applicable.
INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A COMPACT
DISC
[0004] Not Applicable.
BACKGROUND OF THE INVENTION
[0005] 1. Field of the Invention
[0006] The present invention relates generally to orthopedic
fixation devices, fasteners, and implants that are used in
orthopedic surgery, neurosurgery, plastic surgery, hand surgery,
foot and ankle surgery, and Ear-Nose-Throat (ENT) surgery. These
devices, such as: pedicle screws, rods, cross-links, plates, set
capping screws, spinal fusion interbody spacers for
lumbar/thoracic/cervical spine (both stand alone and with
associated interbody and plate combination, and corpectomy cages
(both stand alone devices and separate corpectomy and plate
combinations), among others, are used, for example, to facilitate
spine stabilization and healing after spinal fusion surgery; in
addition to being used to stabilize other types of orthopedic bony
fractures (such as long-bone or facial fractures) in trauma
departments. Some of these devices may also be used in plastic
surgery and oral/facial surgery, hand and foot surgery, and
ear-nose-throat surgery for a variety of pathologies, including
mandibular and facial fractures, extremity fractures, oncologic
disease of the skeleton and skull, and traumatic disease of the
skeleton and skull.
[0007] 2. Description of Related Art
[0008] Millions of people suffer from a variety of musculoskeletal
disorders or traumatic occurrences necessitating the use of methods
and devices to provide reliable spinal stabilization and facilitate
rapid healing. Stabilization may be accomplished with mechanical
fasteners, implants, and fixation devices such as pedicle screws,
rods, cross-links, plates, vertebra interbody spacers, and
corpectomy cages.
[0009] Pedicle screw fixation has been shown to be superior to
other methods of instrumentation of the lumbar and thoracic spine
for spinal fusion and correction of deformity. However, there are
many complications associated with placement of screws within the
lumbar and thoracic spine, as well as the entire spinal axis.
Pedicle perforation is noted to be as high as 40%, which increases
likelihood of dural tears, nerve root injuries, paraplegia, and
vascular injury.
[0010] Non union and pseudoarthrosis rates have been shown to be as
high as 10% to 40%. Screw pullout rates are noted to be as high as
5-20%. Infection continues to be a devastating problem
post-operatively in patients with spinal instrumentation and
fusion.
[0011] Surgical techniques for the treatment of spinal injuries or
deformities (e.g., scoliosis) are usually aimed at joining together
two or more adjacent vertebrae of the spine, through a procedure
that is called spinal fusion. A common approach to spinal fusion
adopts a fixation system that is anchored to the spine by way of
orthopedic screws implanted into the pedicles of two or more
adjacent vertebrae. The single screws (i.e., pedicle screws) are
connected together by means of rigid or semi-rigid rods, thereby
forming a rigid cage that stabilizes and protects the spine. In
previous versions, the connecting rod was housed within a
transversal hole provided in the pedicle screw head itself.
However, due to the irregularity of bone anatomy, it was unlikely
that once the screws had been implanted into the spine pedicles
that the transverse holes in their heads would be properly aligned
for rod insertion. Hence, in order to facilitate the alignment and
insertion of the rod, modern pedicle screws are provided with a
rotatable, rod-receiving connecting member (connector) that freely
rotates and swivels with respect to the screw's shaft.
[0012] Screws of this type, named polyaxial screws, comprise a
threaded shaft with a hemi-spherical polyaxial. The polyaxial drive
end is typically housed inside a mating, hemi-spherical recess
(i.e., as a ball & socket joint) provided in the rod-receiving
connecting member (rod-connector). A transversal hole, or U-shaped
channel, in the rod-connector houses the connecting rod; and a
set-screw or threaded-plug insert is provided above the rod, which
clamps the rod into a rigid, locked position. In typical polyaxial
pedicle screws, such as the example disclosed in U.S. Pat. No.
5,672,176, the locking action of the set-screw determines the
locking of both the connecting rod and the bone screw's
orientation, since pressure applied by the set-screw is transmitted
to both the connecting rod and the screw's hemi-spherical drive
head.
[0013] These implantable, orthopedic fixation devices are typically
made of a rigid material, such as a titanium alloy or stainless
steel. While the use of such rigid materials provides sufficient
strength and load-carrying capabilities to avoid fractures or
breakage, the interface between the metallic device and the
surrounding bone is relatively non-flexible and unyielding.
[0014] Alternatively, these devices may be formed of semi-rigid
materials, such as polymeric materials (e.g., PEEK). While the use
of such semi-rigid materials provides a more flexible or yielding
interface between the device and the surrounding bone, the strength
and structural load carrying capabilities of polymeric bone anchor
are generally less than metal alloys.
[0015] Bone autograft and allograft and/or autograft materials are
a third alternative, and they are commonly used for vertebra
interbody fusion spacers, in part, due to their capability for
bio-integration at bone-to-bone interfaces. While bone is quite
strong in compressive loading, it is relatively weak in tension and
shear. For this reason, structural (load-bearing) orthopedic
fixation devices and fasteners (e.g., pedicle screws) are not often
made of allograft (cadaver bone) and/or autograft bone tissue.
[0016] Thus, there remains a need for improved materials for use in
orthopedic fixation devices, implants, and fasteners, especially
for spinal stabilization, which optimally combine the best
properties of all three types of materials described above; and
corresponding methods for implementing same.
BRIEF SUMMARY OF THE INVENTION
[0017] Accordingly, the inventor herein discloses innovative
orthopedic fixation devices and methods, such as pedicle screws,
rods, plates, set-screws, spinal interbody spacers, and cages, to
facilitate healing of fractured bones and for spine stabilization.
The innovative devices are made of composite materials comprising
both bone and metal, in a variety of compositions and geometric
configurations; that are designed to provide both the necessary
strength and load-carrying capabilities, along with means and
methods for enhanced bio-integration of the devices with the
surrounding bone tissue.
[0018] Thus, in a typical embodiment, the present invention
provides an orthopedic bone screw for use in a surgical procedure.
The screw can comprises a polyaxial, hemi-spherically shaped drive
head, and a body. The body comprises a distal tip; and a threaded
shaft extending from the drive head to the distal tip, wherein the
shaft comprises a cannulation extending from the drive head along
at least a portion of the length of the shaft; wherein the
cannulated portion of the shaft contains a least one radial
fenestration connecting the cannulated portion to the outer surface
of the screw; wherein the bone screw is constructed of a composite
material comprising allograft and/or autograft bone and a metal or
metal alloy.
[0019] In various embodiments, the bone screw may be constructed
with a multi-layered composite structure comprising a core and two
layers; wherein the core is made of allograft and/or autograft
bone, the middle layer is a metal or metal alloy, and the outermost
layer is allograft and/or autograft bone. In certain embodiments,
the bone screw may be constructed of a material comprising about
50% allograft and/or autograft bone and about 50% metal or metal
alloy. In some embodiments, each layer (core, middle, and outer)
has approximately the same radial thickness (i.e., 1/3, 1/3, 1/3).
In various embodiments, the metal or metal alloy may be a titanium
alloy, cobalt-chromium alloy, niobium alloy, and tantalum alloy. In
another embodiment, the titanium or metal parts are replaced with
carbon or graphite fiber reinforced parts in similar ratios as
described above with the titanium embodiment.
[0020] In another embodiment, the bone screw has a torque shear of
at least 0.10-0.20 newton-meters. In another embodiment, the bone
screw has a pullout force of 500-700 Newtons.
[0021] Still referring to the bone screw, the shaft may be threaded
from the drive head to the tip. In another embodiment, the threaded
shaft tapers outwardly adjacent to the drive head to form a tapered
undercut for the drive head in such a way allowing the drive head
to rotate close to 90 degrees in all directions, with 360 degrees
rotational capacity of the drive head. In another embodiment, the
cannulated portion of the shaft contains a plurality of
fenestrations that connect to the center of the screw, and the
fenestrations may be spaced so as to occur every two full rotations
of the threaded shaft. In another embodiment, each fenestration may
be square and 2 mm in width and height.
[0022] Still referring to the bone screw, the allograft and/or
autograft bone may be cancellous or cortical bone, or a combination
of both. In another embodiment, the bone screw is coated with an
antibiotic solution. In another embodiment, the cannulated portion
of the shaft is filled with stem cells. In various embodiments the
cannulated portion of the shaft is filled with small particles of
allograft and/or autograft bone.
[0023] In various embodiments, the present invention provides a rod
for use in a surgical procedure comprising a shaft having a first
end and a second end wherein the shaft defines a cannulation
extending along at least a portion of the length of the shaft;
wherein the cannulated portion of the shaft contains a least one
fenestration connected to the center of the rod, wherein the rod
may be constructed of a material comprising allograft and/or
autograft bone and a metal or metal alloy.
[0024] In another embodiment, the rod may be constructed of a
material comprising a core and two layers; wherein the core is
allograft and/or autograft bone, the middle layer is a metal or
metal alloy, and the outermost layer is allograft and/or autograft
bone. In certain embodiments, the rod may be constructed of a
material comprising about 50% allograft and/or autograft bone and
about 50% metal or metal alloy. In various embodiments, the metal
or metal alloy may be titanium, cobalt-chromium, niobium alloy, and
tantalum alloy. In another embodiment, the titanium or metal parts
are replaced with carbon or graphite fiber reinforced parts in
similar ratios as described above with the titanium embodiment.
[0025] Still referring to the rod, the allograft and/or autograft
bone may be cancellous or cortical bone. In another embodiment, the
rod is coated with an antibiotic solution. In another embodiment,
the cannulated portion of the shaft may be filled with stem cells.
In various embodiments the cannulated portion of the shaft may be
filled with allograft and/or autograft bone.
[0026] Other composite orthopedic devices, such as composite bars
or composite strips, can be constructed in a manner and fashion
similar to the composite rod described above.
[0027] In various embodiments, the present invention provides a
plate for use in a surgical procedure comprising: a body defining a
posterior side, an anterior side, a first end and a second end; a
first bone screw bore at the first end and configured to cooperate
with a first bone screw to retain the first bone screw at a first
determinative position relative to the body; and a second bone
screw bore at the second end and configured to cooperate with a
second bone screw to retain the second bone screw at a second
determinative position relative to the body, wherein the plate
contains a least one fenestration connecting to the center of the
plate from the posterior side to the anterior side; and wherein the
plate is constructed of a material comprising allograft and/or
autograft bone and a metal or metal alloy.
[0028] In another embodiment, the plate may be constructed of a
material comprising a core and two layers; wherein the core is
allograft and/or autograft bone, the middle layer is a metal or
metal alloy, and the outermost layer is allograft and/or autograft
bone. In certain embodiments, the plate may be constructed of a
material comprising about 50% allograft and/or autograft bone and
about 50% metal or metal alloy. In various embodiments, the metal
or metal alloy may be titanium, cobalt-chromium, niobium alloy, and
tantalum alloy. In another embodiment, the titanium or metal parts
are replaced with carbon or graphite fiber reinforced parts in
similar ratios as described above with the titanium embodiment.
[0029] Still referring to the plate, the allograft and/or autograft
bone may be cancellous or cortical bone. In another embodiment, the
plate is coated with an antibiotic solution. In another embodiment,
the fenestration may be filled with stem cells. In various
embodiments the fenestration may be filled with allograft and/or
autograft bone.
[0030] In various embodiments, the present invention provides a
spinal fusion interbody spacer comprising: a body having superior
and inferior abutment surfaces sized and shaped to be adapted to
abut against adjacent spaced vertebrae; and said body having
concave lateral side surfaces, wherein the spacer contains a least
one fenestration from the inferior surface to the superior surface;
and wherein the spacer is constructed of a material comprising
allograft and/or autograft bone and a metal or metal alloy.
[0031] In another embodiment, the interbody spacer may be
constructed of a material comprising a core and two layers; wherein
the core is allograft and/or autograft bone, the middle layer is a
metal or metal alloy, and the outermost layer is allograft and/or
autograft bone. In certain embodiments, the interbody spacer may be
constructed of a material comprising about 50% allograft and/or
autograft bone and about 50% metal or metal alloy. In various
embodiments, the metal or metal alloy may be titanium,
cobalt-chromium, niobium alloy, and tantalum alloy. In another
embodiment, the titanium or metal parts are replaced with carbon or
graphite fiber reinforced parts in similar ratios as described
above with the titanium embodiment.
[0032] Still referring to the interbody spacer, the allograft
and/or autograft bone may be cancellous or cortical bone. In
another embodiment, the interbody spacer is coated with an
antibiotic solution. In another embodiment, the fenestration may be
filled with stem cells. In various embodiments the fenestration may
be filled with allograft and/or autograft bone.
[0033] A set screw cap that is used to fasten the screw onto the
rod, can be manufactured with all of the same concepts presented
above. In another embodiment, the titanium or metal parts are
replaced with carbon or graphite fiber reinforced parts in similar
ratios as described above with the titanium embodiment.
[0034] A corpectomy cage, either stand alone with attached plate on
superior and inferior ends on anterior aspect of cage, or in
isolation without associated plate, can be manufactured with all of
the same concepts presented above. The titanium or metal products
in another embodiment may be replaced with carbon fiber product in
exact ratio as described above with the titanium embodiment.
[0035] Each of the above constructs presented may also be implanted
with a radiofrequency stimulation capability. This will enable
placement of external source of stimulation to the implanted
radiofrequency implant allowing for increased fusion to occur.
[0036] External radiofrequency stimulation can be used with
placement of patch on side requiring increased fusion (i.e.,
fractured extremity and spine). The titanium or metal products in
another embodiment may be replaced with carbon fiber product in
exact ratio as described above with the titanium embodiment.
[0037] In various embodiments, the present invention provides a
method of using a bone screw in a surgical procedure comprising;
providing a bone screw as described above; and inserting said bone
screw into a bone.
[0038] In various embodiments, the present invention provides a
method of using a rod in a surgical procedure comprising; providing
a rod as described above; and fastening the rod to a bone.
[0039] In various embodiments, the present invention provides a
method of using a plate in a surgical procedure comprising;
providing a plate as described above; and fastening the plate to a
bone.
[0040] In various embodiments, the present invention provides a
method of using a spinal fusion interbody spacer in a surgical
procedure comprising; providing a spinal fusion interbody spacer as
described above; and fastening the spinal fusion interbody spacer
to a bone.
[0041] In various embodiments, the present invention provides
various methods for growing a coating/layer of living bone tissue
on the exterior surface of the orthopedic device, either before or
after the device has been surgically implanted.
[0042] In one example, the method can comprise: (1) providing a
central reservoir (e.g., a cannulated portion) comprising a supply
of precursor bone material (i.e., a "bone cocktail") comprising a
mixture of stem cells, small particles of allograft and/or
autograft bone, and (optionally) bone growth factors, such as
BMP-2; then (2) migrating said mixture through fenestrations that
are fluidically-connected to the central reservoir at one end of
the fenestration and to the outer surface of the device at the
other end of the fenestration; (3) migrating/flowing said bone
precursor mixture onto the exterior surface of the device; and,
finally, (4) transforming, over time, the bone precursor mixture
into a continuous, consolidated layer of solid, living bone tissue
that has the capability to infiltrate and bond to a patient's
pre-existing bone structure, thereby enhancing bio-integration of
the orthopedic device or implant.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0043] The details of the present invention, both as to its
structure and operation, may be gleaned in part by study of the
accompanying drawings, in which like reference numerals refer to
like parts.
[0044] FIG. 1 is an isometric, side view of an example of a
polyaxial bone screw device, for use in an orthopedic surgical
procedure, according to the present invention.
[0045] FIG. 2 is a cross-section view along the screw's central
axis, of the example of a polyaxial bone screw device shown in FIG.
1.
[0046] FIG. 3 is an isometric view of an embodiment of a rod for
use in a surgical procedure featuring fasteners for attaching the
rod to a pair of bone screws.
[0047] FIG. 4A is a cross-section longitudinal view of an
embodiment of a rod for use in a surgical procedure.
[0048] FIGS. 4B and 4C are cross-section end views of an embodiment
of a rod for use in a surgical procedure.
[0049] FIGS. 5A-5D are cross-section views of an embodiment of a
plate for use in a surgical procedure.
[0050] FIG. 6 shows an isometric view of a composite bar used with
the invention.
[0051] FIG. 7A is a cross-section view of the embodiment shown in
FIG. 6 along Section 7A-7A.
[0052] FIG. 7B is a cross-section view of the embodiment shown in
FIG. 6 along Section 7B-7B.
[0053] FIG. 7C is a cross-section view of the embodiment shown in
FIG. 6 along Section 7C-7C.
[0054] FIG. 8A is a cross-section view of the embodiment shown in
FIG. 6 along Section 8A-8A after being filed with a bone growth
mixture.
[0055] FIG. 8B is a cross-section view of the embodiment shown in
FIG. 6 along Section 8B-8B after being filed with a bone growth
mixture.
[0056] FIG. 8C is a cross-section view of the embodiment shown in
FIG. 6 along Section 8C-8C after being filed with a bone growth
mixture.
[0057] FIG. 9A is a cross-section view of the embodiment shown in
FIG. 6 along Section 9A-9A after being filed with a bone growth
mixture that has consolidated.
[0058] FIG. 9B is a cross-section view of the embodiment shown in
FIG. 6 along Section 9B-9B after being filed with a bone growth
mixture that has consolidated.
[0059] FIG. 9C is a cross-section view of the embodiment shown in
FIG. 6 along Section 9C-9C after being filed with a bone growth
mixture that has consolidated.
[0060] FIG. 10 is a cross-section view of a composite corpectomy
cage.
[0061] FIG. 11 shows an isometric view of an inferior support plate
used with the invention.
[0062] FIG. 12 shows an isometric, cutaway view of an outer
corpectomy tube used with the invention.
[0063] FIG. 13A shows the embodiment of FIG. 1 receiving a syringe
for injecting a bone growth mixture.
[0064] FIG. 13B illustrates the injection of a bone growth mixture
in accordance with the present invention.
DETAILED DESCRIPTION OF THE INVENTION
Abbreviations and Definitions
[0065] To facilitate understanding of the invention, a number of
terms and abbreviations as used herein are defined below as
follows:
[0066] When introducing elements of the present invention or the
preferred embodiment(s) thereof, the articles "a", "an", "the" and
"said" are intended to mean that there are one or more of the
elements. The terms "comprising", "including" and "having" are
intended to be inclusive and mean that there may be additional
elements other than the listed elements.
[0067] The term "and/or" when used in a list of two or more items,
means that any one of the listed items can be employed by itself or
in combination with any one or more of the listed items. For
example, the expression "A and/or B" is intended to mean either or
both of A and B, i.e. A alone, B alone, or A and B in combination.
The expression "A, B and/or C" is intended to mean: A alone, B
alone, C alone, A and B in combination, A and C in combination, B
and C in combination, or A, B, and C in combination.
[0068] The term "allograft and/or autograft bone material" as used
herein is broadly defined as bone tissue that is harvested from
another individual (allograft), and/or the same individual
(autograft) of the same species. Allograft and/or autograft tissue
may be used in its native state, or modified to address the needs
of a wide variety of orthopedic procedures. The vast majority of
allograft and/or autograft bone tissue is derived from deceased
donors (cadaver bone). Bone is about 70% mineral by weight. The
remaining 30% is collagen and non-collagenous proteins (including
bone morphogenic proteins, BMPs). Allograft bone that has been
cleaned and prepared for grafting provides a support matrix to
conduct bone growth, but is not able to provide growth factors that
induce the patient's biology to form bone cells and create new bone
tissue. In a preferred embodiment, allograft bone is cleaned,
sanitized, and inactivated for viral transmission.
[0069] The term "cancellous bone" refers to the medullary portion
of bone, devoid of hematogenous and other cellular material. When
compared to cortical bone (defined below) cancellous bone is less
dense, less stiff, softer, weaker, and more porous. Cancellous bone
is also called trabecular bone or spongy bone. Cancellous bone is
generally derived from human or animal cadavers.
[0070] The term "cortical bone", also known as "compact bone",
generally comprises the dense, outer surface of bones that forms a
protective layer around the internal bone tissue (such as internal
cancellous bone). Cortical bone is harder, stronger, stiffer, and
more dense than other forms of bone.
[0071] The term "antibiotic" is art recognized and includes
antimicrobial agents synthesized by an organism in nature and
isolated from this natural source, and chemically synthesized
drugs. The term broadly includes but is not limited to: polyether
ionophores such as monensin and nigericin; macrolide antibiotics
such as erythromycin and tylosin; aminoglycoside antibiotics such
as streptomycin and kanamycin; .beta.-lactam antibiotics (having a
.beta. lactam ring) such as penicillin and cephalosporin; and
polypeptide antibiotics such as subtilisin and neosporin.
Semi-synthetic derivatives of antibiotics, and antibiotics produced
by chemical methods are also encompassed by this term. Chemically
derived antimicrobial agents such as isoniazid, trimethoprim,
quinolones, fluoroquinolones and sulfa drugs are considered
antibacterial drugs, and the term antibiotic includes these. It is
within the scope of the present invention to include compounds
derived from natural products, and compounds that are chemically
synthesized. The term "antibiotic" as used herein includes those
antimicrobial agents approved for human use.
[0072] The terms: "polyaxial bone screw", "polyaxial screw", and
"bone screw" all refer broadly to a device (a screw) with a
hemispherical drive head that can be rotatably-mounted in a
connecting member comprising a U-shaped channel sized for rigidly
holding a rod with a set-screw. The connecting member is thereby
allowed to freely rotate to accommodate a wide range of angles
between the rod's axis and the screw's axis. The hemispherical
drive head of a polyaxial screw can be mounted in the
rod-connecting member such that the screw's orientation can be
adjusted angularly with respect to the connecting member, and then
locked into place. Polyaxial screws that do not have hemispherical
heads are also known.
[0073] The term "polyaxial head" as used herein is broadly intended
to encompass all screw heads having connecting members that have
some ability to toggle or pivot in one or more directions about a
center of rotation.
[0074] The term "cannulated portion" or "cannulation" broadly means
a hollow cavity, hole, bore, reservoir, or other type of hollow,
internal volume or space (not necessarily cylindrical in shape)
disposed inside at least part of the orthopedic device or implant
(e.g., pedicle screw, rod, plate, interbody, etc.). For example, a
cannulation may consist of a central bore beginning at or near one
end of a pedicle screw and extending longitudinally along the
central axis of the screw. Other configurations are possible,
however, and the cannulation need not be restricted to having a
cylindrical shape or a circular cross-section.
[0075] A cannulation may extend throughout the entire length of the
orthopedic device, thus creating openings at each end of the device
or implant. Alternatively, a cannulation may extend only partially
into the interior of the device. The shape and size of the
cannulated cavity (e.g., a diameter) may be suitably chosen to
allow delivery of the desired substance, through connected
fenestrations in the device, to the adjacent bone area of interest.
When it is desired to use a cannulated portion of the device as a
storage volume or reservoir for holding the substance to be
delivered, a cannulation can be made as large as possible, just so
long as the device maintains the minimum structural integrity
needed for stabilizing the unstable bony structures.
[0076] The term "cannulated screw" is defined as a screw with a
hollow shaft, and which is suitable for using with a Kirscher wire
(e.g., K-wire).
[0077] The term "cancellous screw" is defined as a screw with a
relatively coarser thread, as compared to a cortical screw, and
which is designed to anchor in softer, medullary bone; and which
often has a smooth, unthreaded upper portion closer to the screw's
head, which allows it to act as a lag screw.
[0078] The term "cortical screw" is defined as a screw with a
relatively fine thread (as compared to a cancellous screw), which
is designed to anchor into denser and harder cortical bone.
[0079] The term "fenestration" is defined broadly as any slot,
hole, via, penetration, gap, perforation, etc. that defines a
fluidic opening, passageway, channel, connection, etc. between the
cannulated portion, region, or zone of the device and the
outside/exterior surface of the device. Thus, for example, a
fenestrated screw comprises an opening or penetration through the
screw's shaft that defines a substance-delivering, fluidic pathway
between an internal cannulation and the exterior surface of the
screw. Fenestrations will typically extend in the radial direction
from the internal cannulation to the exterior of the screw or
implant, but other configurations are possible. Such fenestrations
are separate and distinct from an opening at or near the end of the
device or implant created by an intersection of the cannulation
with the device's outer surface. Further, in accordance with the
present invention, fenestrations may have any necessary shape or
size desired to effect the desired delivery of the desired
substance. For example, fenestration cross-sections may be round,
oval, or square; and may also have a non-uniform cross-section that
changes along the fenestration's length (e.g., a tapered
channel).
[0080] The term "fenestration" includes "microholes" (which can be
empty, or can be bone-filled).
[0081] The term "fenestration" is also broadly defined herein to
include structures and materials that have interconnected porosity;
e.g., in a porous, reticulated, "foam-like" material (e.g.,
partially-sintered porous metal; CVD porous metals and metal
alloys; reticulated graphite; and porous ceramics (aluminum oxide,
silicon nitride, silicon carbide). The network of interconnected
pores in these porous materials can be used to replace drilled
microholes (fenestrations) for providing a substance-delivering,
fluidic pathway between a cannulated storage region inside the
device and the outer surface of the device.
[0082] The term "stem cell" broadly refers to any cells that have
the ability to divide for indefinite periods of time and to give
rise to specialized cells. Stem cells emanate from all germinal
layers (ectoderm, mesoderm and endoderm). Typical sources of stem
cells include embryos, bone marrow, peripheral blood, umbilical
cord blood, and placental blood. Stem cells can be pluripotent,
meaning that they are capable of generating most tissue on an
organism. For example, pluripotent stem cells can give rise to
cells of the skin, liver, blood, muscle, bone
[0083] The term "composite" broadly includes laminated materials
that have a laminated or multi-layered type of construction; for
example, a structure that is made up of alternating layers of
different materials (e.g., bone as layer #1, and metal as layer #2,
and bone as layer #3, etc.).
[0084] The term "orthopedic device" and "device" is broadly defined
herein to include composite orthopedic fixation devices, fasteners,
and implants (e.g., bone+metal composite devices).
[0085] The words "may" and "can" are used interchangeably herein.
For example, the phrase: "the metal or metal alloy may be titanium
alloy" is equivalent to the phrase: "the metal or metal alloy can
be titanium alloy."
Devices
[0086] Certain embodiments are disclosed herein, according to the
present invention, that provide innovative orthopedic devices and
implants that facilitate, for example, improved spine
stabilization, such as: bone screws (e.g., pedicle screws), rods,
cross-links, plates, set-screws, spinal interbody spacers, and
corpectomy cages. They are designed to provide sufficient strength
and load carrying capabilities, while also enhancing
bio-integration of the devices with the surrounding bone
tissue.
[0087] While the devices will be described as, and may generally be
used in, the spine (for example, in the lumbar, thoracic or
cervical regions), those skilled in the art will appreciate that
these devices may be used in other bony parts of the body such as,
for example: joints, long bones, or bones in the hand, face, feet,
extremities, cranium, bony plates for fracture or tumor throughout
the body; and hip/knee/ankle/extremity arm or leg
screws/rods/plates, etc. The devices may be designed in different
lengths and proportions; and can be used in cervical, thoracic,
lumbar, sacral, occipital, extremity and orthopedic surgery. The
devices may additionally incorporate optional attachments to
robotic members that can provide high (3-D) spatial coordinate
resolution via robot-guided tracking of, e.g., pedicle screw
placement (e.g., Mazor Robotics RenaissanceTM hexapod coordinate
tracking tool) and/or direct insertion and placement via robotic
tools, such as the Da Vinci.RTM. robotic arms.
[0088] The orthopedic devices of the present invention may be made
from biologically-compatible materials (e.g., medical-grade
stainless steel, titanium alloy, or other metals; polymers, such as
PEEK, polyurethane, silicon, polylactic acid (PLA), polyglycolic
acid (PLGA); or other polymeric materials; ceramics; other
materials that are exogenous, some materials derived from animals
(e.g., naturally occurring or chemically-modified molecules such as
collagen, hyaluronic acid, proteins, carbohydrates, and others);
human donor tissues (e.g., "allograft" such as whole organs;
tissues such as bone grafts, skin grafts, and others); or from the
patients themselves (e.g., "autografts").
[0089] Additionally, embodiments using carbon/graphite fiber
reinforcement technology (including
nanofiber/nanorod/whisker/graphene sheet technology) may completely
replace, or, be used along with, the metal or metal alloy
components/layers (e.g., titanium component).
[0090] In some embodiments of the present invention, the orthopedic
device is constructed as a composite structure made of at least two
different types of materials: (1) a rigid or semi-rigid
load-bearing material (e.g., metal, ceramic, ceramic-metal
composite, or a fiber-reinforced material, such as graphite fiber
reinforced plastic, carbon-fiber composite, SiC-fiber reinforced
SiC, etc.)), and (2) a more compliant (less rigid) material (e.g.,
polymer, allograft or autograft bone, which can be cancellous or
cortical bone, graphite or carbon).
[0091] In some embodiments, the orthopedic device may be
constructed as a multi-layered composite configuration comprising a
core and two surrounding layers (middle and outer layers); wherein
the core is a more compliant (less rigid) material (e.g., allograft
and/or autograft bone), the middle layer is a rigid or semi-rigid
load-bearing material (e.g., a metal or metal alloy), and the outer
layer is a more compliant (less rigid) material (e.g., allograft
and/or autograft bone. In some of these embodiments, the composite
configuration may comprise about 50% allograft and/or autograft
bone, and about 50% metal or metal alloy. In other embodiments,
each layer (core, middle, and outer) has approximately the same
thickness as the other two layers (i.e., 33%, 33%, 33%). In other
embodiments, the thickness of the different layers can be chosen to
be any thickness that provides the necessary and/or optimum
properties for a specific design. In other embodiments, the "metal
or metal alloy" may comprise a titanium alloy, cobalt-chromium
alloy, niobium alloy, tantalum alloy, or a stainless steel alloy.
In another embodiment, the titanium or metal parts are replaced
with carbon or graphite fiber reinforced parts in similar ratios as
described above with the titanium embodiment.
[0092] In some embodiments, the outermost bone layer comprises a
thin shell of allograft/autograft bone that has been micro-machined
to closely fit the outer contours and surface of the middle metal
layer; in which case the thin shell of bone is glued onto the metal
substrate, or attached some other way. Alternatively, a mixture
comprising primarily ground up particles of allograft/autograft
bone and a biologically-acceptable binder material is sprayed onto
the metal substrate (preferably with a roughened metal surface),
followed by baking and curing to remove the volatile binder,
thereby leaving an essentially 100% pure, nearly fully-dense
allograft/autograft outermost bone layer.
[0093] In some embodiments, the inside and/or outside surfaces of
the metal structural layer (e.g., titanium alloy) can comprise a
nano-textured or nano-porous surface layer or coating, which
enhances bonding, bond strength, and bond fatigue life by providing
an extended surface area for mechanical interlocking, enhanced
chemical reactivity, and reduced stresses across a graded
interlayer. This can be accomplished, for example, by
electrospinning a very thin, titanium-oxide based, ceramic nanowire
scaffolding (nano-porous layer) on a titanium substrate. This has
been demonstrated for hip replacement, dental
reconstruction/implants, and vascular stenting. Such a surface
treatment can increase attachment of the orthopedic device to the
surrounding bone, and increase pullout strength.
[0094] In other embodiments of the present invention, the
orthopedic device is constructed as a skeleton structure that is
only made of the rigid or semi-rigid load-bearing material (e.g.,
metal, ceramic, ceramic-metal composite). Then, at some time either
(a) before the device is surgically implanted, or (b) after the
device has been implanted, but still during surgery, the empty/open
cannulation(s) and/or the fenestrations inside of the device's
skeleton structure are filled (infiltrated) with a liquid or
gel-like "bone growth cocktail" or "Liquid Bone". In some
embodiments, a bone growth cocktail can comprise a mixture of: (a)
stem cells, (b) small particles/powder/chips of allograft and/or
autograft bone, (c) one or more bone growth
factors/adjuncts/stimulants, such as BMP's (bone morphogenic
proteins, e.g., BMP-2 (except not for the anterior cervical spine
as BMP-2 is contraindicated)) and/or (d) a demineralized bone
matrix or bone chips substrates composed of cadaveric allograft
material with stem cells, which will transform into solid, living
bone tissue (after having been implanted inside of a patient's
body).
[0095] In other embodiments, such a bone growth cocktail mixture
can additionally, or optionally, comprise an efficacious dose of
Teriparatide (ForteoTM, made by Eli Lilly, Inc.), which is a
recombinant human version, rDNA, of a portion (amino acid sequences
1-34), of the full human parathyroid hormone, PTH, which contains
84 amino acids. When used for the FDA-approved method of treating
osteoporosis, once-daily injections of teriparatide has been found
to activate osteoblasts more than osteoclasts, and thus has a net
effect of stimulating new bone formation leading to increased bone
mineral density. Additional testing would be needed, however, to
demonstrate the usefulness of constant (i.e., non-intermittent)
exposure of a bone graft site or bone fusion site to Teriparatide
(PTH 1-34).
[0096] The bone growth source mixture comprising stem cells, small
particles of allograft and/or autograft bone, bone growth factors,
etc. migrates from the cannulation (storage reservoir) and flows
(diffuse) radially outwards through the fenestrations. Upon exiting
the fenestrations, they can deposit locally and/or disperse and
migrate or flow across the exterior surface of the device,
eventually depositing on the device's surface. Then, given the
proper environmental conditions, a thin layer of living bone tissue
begins to grow, and eventually forms a continuous, consolidated
layer (coating) of solid, living bone tissue. The layer of living
bone can be, for example, 1-2 mm thick, and it can infiltrate and
bond to the patent's pre-existing bone structure (e.g., a vertebra
bone), thereby enhancing the bio-integration of the orthopedic
device with the patient's own bony structures. The outer layer of
bone is attached, in part, to the central core of bone via the bony
limbs inside of the fenestrations that connect those layers.
[0097] In some embodiments, the exterior surface of the device
(pedicle screw, rod, plate, etc.) can have a roughened or pitted
surface (chemically or mechanically etched or pitted) to provide an
enhanced/extended surface area for locking-onto the coating of
living bone tissue. Optionally, the roughened surface can be
pre-coated (before the device is surgically implanted) with a
nano-thin or micro-thin layer of apatite or hydroxyapatite
bone-like material to provide a precursor/prepared surface that
helps bone growth and subsequently enhances bonding and
bio-integration of the device.
[0098] In some embodiments, the cannulated portion(s) of the device
can be pre-filled with the bone cocktail mixture and stored in a
frozen state prior to use.
[0099] In some embodiments, the bone cocktail mixture can
additionally comprise silver nanoparticles, which provide
additional antibiotic capability.
[0100] In one of the embodiments presented above, the orthopedic
device is implanted during surgery as an empty skeleton structure,
i.e., without any bone tissue inside. Then, after implantation, but
still during surgery, a bolus of the liquid or gel-like bone
cocktail mixture is loaded/injected into the device's
cannulation(s) of the device. Then, over a period of time, the bone
mixture migrates/diffuses outwards through a series of
fenestrations (that fluidically connect the inner cannulation to
the outer surface of the device) and onto the surface of the device
(as described previously).
[0101] Furthermore, as shown in FIGS. 13A and 13B, the bone
cocktail mixture can be initially injected by applying a high
pressure and forcing the mixture under pressure to flow more
rapidly through the fenestrations and out into the surrounding
tissue of the patient's body for some distance (e.g., few mm's). If
the device has been implanted into a bony structure (e.g., a
pedicle of a vertebra), then the surrounding tissue can comprise
porous, cancellous bone. In this case, the bone cocktail mixture
will infiltrate into the surrounding porous, cancellous bone (which
could include damaged or diseased bone tissue), thereby
strengthening and enhancing the bio-integration of the implanted
device with the surrounding bony structure when the bone cocktail
transforms into solid, living bone tissue. In embodiments where the
implanted device is a bone screw, then using this method of forcing
the bone cocktail mixture to infiltrate and reinforce the
surrounding bone will result in increased pullout strength of the
bone screw in the pedicle.
[0102] The method described above of applying a high pressure
(e.g., by using a syringe with a tip mechanically coupled to an
open end of a cannulation) and forcing the mixture to flow more
rapidly under pressure through the fenestrations and out into the
surrounding tissue of the patient's body for some distance, can be
applied to any of the composite orthopedic devices described in the
present specification, including, but not limited to: bone screws,
plates, rods, bars, crosslinks, discs, tubes, cylinders, set
screws, interbody spacers, and corpectomy cages. This method can be
used before, or after, or both before and after, the orthopedic
device has been surgically implanted.
[0103] In some embodiments, a polyaxial bone screw that is devoid
of any bone tissue (i.e., an empty skeleton structure) would be
similar to a "cannulated screw" (which has a full-length
cannulation that makes it suitable for using with a Kirscher wire
(e.g., K-wire)), which has been modified by the addition of
fenestrations (holes) that connect the surface to the cannulation.
However, it might be necessary to insert a plug (not illustrated)
to block the exit end of the cannulation 20 at the distal end 16 of
the screw (See FIG. 1). Plugging the distal end of the cannulation
20 would prevent any undesirable loss of bone growth cocktail
flowing out the distal end 16, especially if the bone cocktail is
being injected into the cannulation 20 to force it to flow outwards
through the radial fenestrations 20.
[0104] All surfaces of the different components and parts of a
composite orthopedic device, according to the present invention,
can be coated with an antibiotic solution, including, but not
limited to: any titanium or other metal parts, including the inside
of any cannulations or fenestrations.
[0105] In some embodiments, the orthopedic devices of the present
invention can provide radiofrequency (RF) stimulation capability by
incorporating bioengineered, RF-activated implants inside of the
orthopedic device, which is capable of responding to external
sources of RF stimulation and stimulating activity of the
associated implant in order to increase bone fusion and prevent
pseudoarthrosis and implant failure, and neurologic injury and
re-operation. These RF-activated implants can also stimulate areas
outside of the implanted device, such as the surrounding patient
bone, to stimulate fusion bone growth in that surrounding area. In
some embodiments, the entire composite orthopedic device has
RF-activating capacity. In other embodiments, only part of the
orthopedic device has RF-activating capacity (e.g., such as a
special insert of RF-receiving material implanted inside of, or
attached to the surface of, the composite orthopedic device).
RF-receiving material that can be used as an RF-activating implant
include (1) a conducting antenna structure capable of receiving
RF-radiation, and (2) materials (e.g., polymers, water-containing
materials, hydrated-materials) that have a high polar-moment,
capable of being rapidly and efficiently heated by RF microwave
radiation.
[0106] Previously, an embodiment was disclosed that included the
rDNA hormone, Forteo.TM. (Teriparatide, PTH 1-34), in a bone growth
cocktail. To achieve an optimum effect on bone growth, however, the
hormone should ideally be "injected" once a day; in an intermittent
fashion. In one embodiment, the composite orthopedic device
comprises Externally-Activated (EA) means for releasing a fixed
volume of a liquid (i.e., Forteo.TM. either alone, or combined with
the bone growth cocktail mixture), from an internal storage
reservoir (i.e., a cannulation), where it is pumped or otherwise
moves/migrates away from the implanted device and is
delivered/deposited to a region where bone growth (preferably
enhanced growth) is desired. The external activation (EA) can be
due to exposing the body with the implant to a localized source of
RF-radiation, a localized magnetic field (pulsed or steady), or a
combination of both. Inside of the orthopedic device, a MEMS-type
micro-valve (connected to the cannulation) can control the flow of
liquid Forteo.TM. and/or bone growth cocktail, and can open or
close upon being exposed to the RF-radiation or magnetic field.
Another mechanism for causing a micro-valve to open/close is a
local temperature rise due to localized heating from RF-radiation
(e.g., microwave radiation).
[0107] In preferred embodiments of the present invention, the
composite orthopedic devices comprise one or more cannulations
(storage reservoirs) connected to the exterior surface of the
device via one or more fenestrations. In general, unless otherwise
specified, the orthopedic device comprises a sufficient number and
spacing of fenestrations and a sufficient number and volume of
cannulations to supply a bone growth cocktail mixture to all
exposed, exterior surfaces of the device. However, in specific
applications, it may be undesirable to have an outer layer of bone
covering the internal, structural layer of the device (e.g., a
titanium layer). For example, in order to preserve zero-profile
(zero-P) sidewall surfaces of an interbody spacer, it would be
undesirable to include fenestrations in those sidewall sections.
Or, where metal-to-metal contact needs to be made between mating
surfaces (e.g., in a corpectomy cage) no fenestrations would be
included that penetrate those particular mating surfaces.
[0108] In some embodiments, fenestrations are 1-2 mm in diameter,
and are spaced apart a distance of 2-5 mm. These holes can be
drilled with a traditional drill.
[0109] Alternatively, or additionally, a high-powered laser or
water-jet machine can be used to drill 100's to 1000's of these
types of microholes using robotic technology, which can have the
same or much smaller diameter; and that can have the same or much
smaller spacing between holes, if needed. Decreasing the spacing
between fenestrations (while increasing the number of
fenestrations) can reduce potentially undesirable variations in the
thickness of the outer bone layer from hole to hole.
Examples of Composite Orthopedic Devices
[0110] FIGS. 1-12 show examples of various embodiments of composite
orthopedic devices, according to the present invention. Examples of
composite devices that are illustrated include: a polyaxial bone
screw, a rod, a 4-screw spinal fusion construct, a thick plate, a
bar, and an expandable corpectomy tube cage. Other devices, which
are not illustrated, are covered by the methods and designs of the
present invention, including: a composite set screw, a composite
crosslink, and a composite spinal fusion interbody spacer (with or
without angled screw holes).
[0111] FIG. 1 shows an isometric side view of an example of a
polyaxial bone screw device for use in an orthopedic surgical
procedure, according to the present invention. Polyaxial bone screw
device 4 comprises a bone screw 6 rotatably attached to
rod-connecting member 8 (i.e., rod-connector 8). Bone screw 6
(e.g., a pedicle screw) comprises a hemi- or semi-spherical
polyaxial drive head 10 and a body 12. The polyaxial drive head 10
functions as a ball-and-socket joint housed inside of the base of
rod-connector 8. This configuration gives bone screw 6 the ability
to rotate (swivel) close to +/-90.degree., polyaxially (i.e.,
360.degree. relative to the central axis of rod-connecting member
8), as limited by the shape of the polyaxial drive head (10) and on
how it blends/tapers into rod-connector 8. Screw body 12 has a
distal tip 16; and an outwardly cylindrical threaded shaft 14
extending from the drive head 10 to the tip 16; wherein the shaft
14 comprises a cannulation 20 (as illustrated in FIG. 2) extending
along the screw's central axis from the drive head 10 along at
least a portion of the length of the shaft 14. Screw shaft 14
comprises a plurality of radial fenestrations 22 that fluidically
connect cannulation 20 to the exterior surface 18 of shaft 14.
[0112] Still referring to FIG. 1, shaft 14 comprises helical screw
threads 21 from the vicinity of drive head 10 to distal tip 16.
Shaft 14 tapers outwardly adjacent to the drive head 10 to form a
tapered undercut for the drive head. In another embodiment,
fenestrations 22 are spaced apart axially so as to occur every two
full rotations of the threaded shaft. Fenestrations 22 can be
cylindrical, with a diameter of about 2 mm. In another embodiment,
each fenestration has a square cross-section that is about 2 mm in
width and height.
[0113] Bone screws, according to the present invention, such as the
example illustrated in FIGS. 1 and 2, are made of a composite
material comprising at least one layer of allograft and/or
autograft bone, and at least one layer of a metal or metal
alloy.
[0114] FIG. 2 shows a cross-section view cut along the screw's
central axis of the polyaxial bone screw device 4 previously shown
in FIG. 1. Bone screw 6 is made of a multi-layered composite
material comprising a central core 30, surrounded by two layers (32
and 34); wherein the core 30 is made of allograft and/or autograft
bone, the middle layer 32 is made of a metal or metal alloy, and
the outermost layer 34 is made of allograft and/or autograft bone.
In certain embodiments, the overall composition of the bone screw
is about 50% allograft and/or autograft bone and about 50% metal or
metal alloy. In some embodiments, each layer (core 30, middle 32,
and outer 34) has approximately the same radial thickness (i.e.,
1/3, 1/3, 1/3). The metal or metal alloy used for the middle layer
32, and the screw threads, may be titanium, titanium alloy,
cobalt-chromium alloy, niobium alloy, tantalum alloy, or stainless
steel. The allograft and/or autograft bone used in central core 30
and outer layer 34 may comprise cancellous bone, cortical bone, or
a combination of both cancellous and cortical bone. In some
embodiments, bone screw 6 has a torque shear strength of at least
0.10-0.20 Newton-Meters. In another embodiment, bone screw 6 has a
pullout force of at least 500-700 Newtons. In another embodiment,
the titanium or metal parts are replaced with carbon or graphite
fiber reinforced parts in similar ratios as described above with
the titanium embodiment.
[0115] Referring still to FIG. 2, in one embodiment, the composite
bone screw is coated with an antibiotic solution. In another
embodiment, the cannulated portion 20 of shaft 14 is filled with
stem cells. In another embodiment, the cannulated portion 20 of
shaft 14 is filled with allograft and/or autograft and/or autograft
bone. In another embodiment, the cannulated portion 20 of shaft 14
is filled with one or more bone growth factors, such as BMP-2. In
another embodiment, the cannulated portion 20 of shaft 14 is filled
with a combination of stem cells, allograft and/or autograft and/or
autograft bone, and one or more bone growth factors, such as
BMP-2.
[0116] FIG. 3 shows an isometric view of a spine stabilization
assembly (e.g., for stabilizing lumbar vertebra L4/L5), according
to the present invention. The assembly comprises a pair of
composite rods 26, with each rod 26 being connected to a pair of
composite bone screws 6 (e.g, pedicle screws). Each rod 26 is
positioned in the U-shaped channel/opening 24 of rod-connecting
member 8, and secured with one (or more) set-screws 28. Set-screw
28 is threadedly disposed within the rod-connecting member 8, and
is operable for compressing the rod 26 against the top of screw
head 10, thereby rigidly securing the rod in place. Multiple
examples of fenestrations 22 can be seen in FIG. 3.
[0117] In various embodiments, set-screw 28 may be constructed of a
composite material comprising a core and two layers; wherein the
core is allograft and/or autograft bone, the middle layer is a
metal or metal alloy, and the outermost layer is allograft and/or
autograft bone. In certain embodiments, the set screw may be
constructed of a material comprising about 50% allograft and/or
autograft bone and about 50% metal or metal alloy. In various
embodiments, the metal or metal alloy may be titanium,
cobalt-chromium, niobium alloy, and tantalum alloy. The allograft
and/or autograft and/or autograft bone may be cancellous or
cortical bone. In another embodiment, the set screw is coated with
an antibiotic solution. In another embodiment, the titanium or
metal parts are replaced with carbon or graphite fiber reinforced
parts in similar ratios as described above with the titanium
embodiment.
[0118] FIG. 4A shows a cross-section view cut along the length of a
composite rod for use in an orthopedic surgical procedure,
according to the present invention. Rod 26 comprises a shaft 36
having a proximal first end 37 and a distal second end 39, wherein
the shaft 36 comprises a cannulation 38 extending along at least a
portion of the axial length of the shaft; wherein the cannulated
length 38 of the shaft contains at least one radial fenestration
40; wherein the rod 26 is constructed of a composite multi-layered
material comprising allograft and/or autograft and/or autograft
bone, and a metal or metal alloy. In this example, cannulation 38
extends along the entire length of rod 26, and intersects the
distal second end 39 of shaft 36; wherein the intersection defines
opening 41 at the distal end of cannulation 38. Opening 41 can be
used to access the cavity (hollow space) of cannulation 38 and fill
the cavity with stem cells and other bone growth material, such as
a bone cocktail precursor mixture. After filling the cannulation 38
with the bone precursor mixture, then opening 41 can be plugged or
otherwise closed, if needed. Optionally, the filling of cannulation
38 can be performed with sufficient pressure to also completely
prefill the radial fenestrations 40 with the bone precursor
mixture.
[0119] Referring still to FIG. 4A the composite orthopedic rod 26
may be constructed of a multilayered composite material comprising
a core and two layers; wherein the core 42 is allograft and/or
autograft and/or autograft bone, the middle layer 44 is a metal or
metal alloy, and the outermost layer 46 is allograft and/or
autograft and/or autograft bone. In certain embodiments, the
composite rod may be constructed of a material comprising about 50%
allograft and/or autograft and/or autograft bone and about 50%
metal or metal alloy. In some embodiments, each layer (core 42,
middle 44, and outer 46) has approximately the same radial
thickness (i.e., 1/3, 1/3, 1/3). In various embodiments, the metal
or metal alloy may be titanium alloy, cobalt-chromium, niobium
alloy, and tantalum alloy. In another embodiment, the titanium or
metal parts are replaced with carbon or graphite fiber reinforced
parts in similar ratios as described above with the titanium
embodiment. Still referring to the composite rod, the allograft
and/or autograft bone may be cancellous or cortical bone. In
another embodiment, the composite rod is coated with an antibiotic
solution. In another embodiment, the cannulated portion of the
shaft may be filled with stem cells. In various embodiments the
cannulated portion of the shaft may be filled with allograft and/or
autograft bone.
[0120] FIG. 4B shows a cross-section view showing a first plane,
A-A, cut perpendicular to the long axis of the rod 26. In this
view, the central core 42 (made of bone), the middle layer 44 (made
of metal or metal alloy), and the outer layer 46 (made of bone),
can be seen as cross-hatched layers.
[0121] FIG. 4C shows a cross-section view of a second plane, B-B,
cut perpendicular to the long axis of the rod, passing through a
set of fenestrations. Cannulation 38 is centered along the central
axis of the rod, and is connected to four radial fenestrations 40,
which are oriented at every 90.degree. to each other. The
cannulation 38 and radial fenestrations 40 are filled with solid
bone. The middle layer 44 (made of metal or metal alloy), and the
outer layer 46 (made of bone), can be seen. In other embodiments,
one or more cannulations (not shown) can be placed off-axis from
the rod's central axis. In other embodiments, the rod can be curved
(non-straight) to match a patient's specific anatomy.
[0122] FIG. 5A shows an isometric view of a composite plate for use
in an orthopedic surgical procedure, according to the present
invention. Plate 50 comprises a main/structural body 64 defining a
top side 52, an bottom side 54, a set of four bone screw bore holes
58 (two holes at each end of the plate) configured to cooperate
with four corresponding bones screw (not shown) to attach the plate
to bony structure(s) within the body; wherein the plate contains a
plurality of fenestrations 60 (32 fenestrations in this example),
where each fenestration is a small hole that penetrates from the
top side 52 down through a cannulation 56 or 57, then passing down
and out through the back side 54; and wherein the plate is
constructed of a composite material comprising allograft and/or
autograft bone and a metal or metal alloy.
[0123] FIGS. 5B and 5C show a pair of cross-section views cut
through the composite plate at two different locations, A-A, and
B-B, (see FIG. 5A for the location of the cutting planes). In these
embodiments, plate 50 comprises multiple layers of different
materials, for example: a core layer 62 (see FIG. 5C) and two other
layers, 64 and 66; wherein the core layer 62 is allograft and/or
autograft bone, the middle layer 64 is a metal or metal alloy, and
the outermost layer 66 is allograft and/or autograft bone.
[0124] In certain embodiments, the plate may be constructed of a
material comprising about 50% allograft and/or autograft bone and
about 50% metal or metal alloy. In other embodiments, each layer
has approximately the same thickness (e.g., 20%, 20%, 20%, 20%,
20%) since there are a total of 4 layers in a complete plate: i.e.,
core layer 62, middle layer 64 (top and bottom layers), and outer
layer 66 (top and bottom layers) for a total of 5 layers). In
various embodiments, the metal or metal alloy may be titanium,
titanium alloy, cobalt-chromium alloy, niobium alloy, tantalum
alloy, or stainless steel. The allograft and/or autograft bone may
be cancellous or cortical bone, or a combination of cancellous and
cortical bone. In another embodiment, the titanium or metal parts
are replaced with carbon or graphite fiber reinforced parts in
similar ratios as described above with the titanium embodiment.
[0125] In another embodiment, the plate is coated with an
antibiotic solution. In another embodiment, the fenestrations may
be filled with stem cells. In various embodiments, the
fenestrations may be filled with allograft and/or autograft
bone.
[0126] FIG. 5D shows a top view of composite plate 50. In this
example, the composite plate has a rectangular shape with an aspect
ratio (as viewed from the top, as in FIG. 5D) of about 2 (meaning
that the length of the plate is about twice as long as the width of
the plate). Other aspect ratios can be used, ranging from square
(1:1) to "long and skinny" (e.g., 5:1 to 6:1). A plate with an
aspect ratio greater than about 10:1 would be considered a "strip"
or a "bar". Plate 50 is illustrated as being a flat plate, however
non-flat (curved) plates can be used without departing from the
general scope of the invention. Accordingly, in other embodiments,
composite plate 50 can be curved (i.e., non-flat) in one, or two,
different directions, depending on the needs of a specific
patient's anatomy. Likewise, in other embodiments, composite plate
50 can have curved, non-flat sidewalls, with the four sidewalls
having the same, or different, curvatures.
[0127] Referring to FIGS. 5A through 5D, a number of other features
are illustrated. The central core layer 62 of plate 50 comprises a
rectangular grid (network) of intersecting cannulations 56 and 57.
This is indicated by the orthogonal grid of dashed lines in FIG.
5D, where the dashed lines correspond to the centerline of each
cannulation. In this example there are four, parallel cannulations
56 that run the entire length of the plate in a direction parallel
to the y-axis (see FIG. 5D). In the other direction, there are
eight, parallel cannulations 57 that run the entire width of the
plate in a direction parallel to the x-axis (see FIG. 5D). The
cannulations in this example are circular holes, and there are a
total of twelve (12) cannulations.
[0128] FIGS. 5A through 5D show a plurality of fenestrations 60,
which penetrate completely through the plate from the top surface
52 to the bottom surface 54, passing through cannulations 56 or 57.
In this example, the central core 62 in FIG. 5C is the same feature
as cannulation 56. Fenestrations 60 provide a fluidic connection
between the cannulations and the exterior surface of the plate.
When the cannulations 56 and 57 are filled with a "bone cocktail"
mixture of stem cells, particles of bone, bone growth factors, and
a liquid or gel-like binder, then the 32 fenestrations 60 provide a
pathway for the bone cocktail to migrate from the cannulations to
the exterior surface of the plate, whereupon they can flow across
the plate's surface to generate full coverage of the surface by the
mixture. After some period of time, the bone growth mixture
(cocktail) transforms into living bone tissue. The outermost layer
66 of living bone tissue is indicated by the dashed line 66 in
FIGS. 5B and 5C. Outer bone layer 66 can be about 1-2 mm thick, in
some embodiments. Composite plate 50 can have a greater, or lessor,
number of fenestrations that illustrated in this example (which has
32 fenestrations); and the spacing between fenestrations can be
adjusted as needed. Likewise, the diameter of each fenestration
hole can be greater, or lessor, than about 1-2 mm. Likewise, the
diameter of the cannulations, and the spacing between cannulations,
can be adjusted as needed. The size and placement of the
cannulations are preferably chosen to not intersect with, or
otherwise interfere with, the bone screw bore holes 58.
[0129] Note that in FIGS. 5A and 5D, only a portion of the
outermost layer 66 of bone is illustrated; the remainder of layer
66 has been artificially removed so that the underlying pattern of
fenestrations 60 can be easily seen.
[0130] In various embodiments, the present invention provides a
spinal fusion interbody spacer (not illustrated) comprising: a body
having superior and inferior abutment surfaces sized and shaped to
be adapted to abut against adjacent spaced vertebrae; and said body
having concave lateral side surfaces, wherein the spacer contains a
least one fenestration from the inferior surface to the superior
surface; and wherein the spacer is constructed of a material
comprising allograft and/or autograft bone and a metal or metal
alloy.
[0131] In another embodiment, the interbody spacer may be
constructed of a material comprising a core and two layers; wherein
the core is allograft and/or autograft bone, the middle layer is a
metal or metal alloy, and the outermost layer is allograft and/or
autograft bone. In certain embodiments, the interbody spacer may be
constructed of a material comprising about 50% allograft and/or
autograft bone and about 50% metal or metal alloy. In various
embodiments, the metal or metal alloy may be titanium,
cobalt-chromium, niobium alloy, and tantalum alloy. Still referring
to the interbody spacer, the allograft and/or autograft bone may be
cancellous or cortical bone. In another embodiment, the interbody
spacer is coated with an antibiotic solution. In another
embodiment, the fenestration may be filled with stem cells. In
various embodiments the fenestration may be filled with allograft
and/or autograft bone. In another embodiment, the titanium or metal
parts are replaced with carbon or graphite fiber reinforced parts
in similar ratios as described above with the titanium
embodiment.
[0132] In some embodiments of cervical interbody spacers, 1-4
screws are angled at roughly 45 degrees for anchoring the interbody
spacer directly into the solid end-plates of the adjacent vertebrae
above and below. This design can eliminate the need to attach a
separate plate to prevent the interbody spacer from accidently
being dislodged. Additionally, these types of interbody spacers
with the 1-4 angled screw holes can also be used for thoracic and
lumbar interbody spacers. Using any type of interbody, it's still
highly desirable to implant/install the interbody so that there is
less than 0.5 mm (ideally, zero-profile) distance of overhanging
material sticking out past the adjoining vertebra (meaning that no
component of the interbody is anterior to the anterior aspects of
the vertebral bodies). No features of the various embodiments of
the present invention should interfere with achieving these goals.
However, if excess bone growth of the outermost layer of bone is a
concern, e.g., around the circumference of the interbody, then a
decision can be made to not include any fenestration holes that
penetrate some, or all, of the circumferential sidewalls of the
interbody, thereby preventing bone growth on those exterior
surfaces (especially the anterior surfaces of the sidewall).
[0133] In various embodiments, the present invention provides a
composite crosslink member (not illustrated), to add stability to a
spinal fusion construct; comprising a composite rod or bar, fitted
with attachment means at both ends for rigidly attaching the
crosslink laterally between a left side and a right side (i.e.,
left and right vertically-oriented rods, such as the pair of rods
shown in FIG. 3. The crosslink devices can be attached from
rod-to-rod, from screw head-to-screw head, or from screw-head to an
adjacent rod. The composite crosslink member contains at least one
fenestration from the inferior surface to the superior surface; and
crosslink member is constructed of a material comprising allograft
and/or autograft bone and a metal or metal alloy. In another
embodiment, the crosslink member may be constructed of a material
comprising a core and two layers; wherein the core is allograft
and/or autograft bone, the middle layer is a metal or metal alloy,
and the outermost layer is allograft and/or autograft bone. In
certain embodiments, the crosslink member may be constructed of a
material comprising about 50% allograft and/or autograft bone and
about 50% metal or metal alloy. In various embodiments, the metal
or metal alloy may be titanium alloy, cobalt-chromium, niobium
alloy, or tantalum alloy. Still referring to the crosslink member,
the allograft and/or autograft bone may be cancellous or cortical
bone. In another embodiment, the crosslink member is coated with an
antibiotic solution. In another embodiment, the fenestration may be
filled with stem cells. In various embodiments the fenestration may
be filled with allograft and/or autograft bone. In another
embodiment, the titanium or metal parts are replaced with carbon or
graphite fiber reinforced parts in similar ratios as described
above with the titanium embodiment.
[0134] FIG. 6 shows an isometric view of an example of a composite
bar for use in an orthopedic surgical procedure, according to the
present invention. Bar 70 comprises a load-bearing structural body
72, with a top side 75, a central cannulation 74 running along the
long direction of the bar, a plurality of fenestrations 72 where
each fenestration is a small hole that penetrates down from the top
side 75, through structural layer 72, and into cannulation 74,
where it stops there (it does not pass through to the bottom side
in this example). FIG. 6 shows an outer layer of bone 82 in two
different stages: (a) initial deposition of a bone growth mixture
78 on the top side 75; and (b) a final stage as a solid,
full-thickness layer 82 of living bone tissue. Orthopedic bar 70 is
constructed as a composite structure made of at least two different
types of materials: (1) a rigid or semi-rigid load-bearing material
(e.g., metal, ceramic, ceramic-metal composite, or a
fiber-reinforced material, such as graphite fiber reinforced
plastic, carbon-fiber composite, SiC-fiber reinforced SiC, etc.)),
and (2) a more compliant (less rigid) material (e.g., polymer,
allograft or autograft bone, which can be cancellous or cortical
bone, graphite or carbon).
[0135] In some embodiments, orthopedic bar 70 can be made of a
composite material comprising allograft and/or autograft bone and a
metal or metal alloy. In some embodiments, the rigid or semi-rigid
load-bearing material is a metal or metal alloy; and the more
compliant (less rigid) material is allograft or autograft bone. In
some embodiments, the metal or metal alloy is titanium alloy. In
other embodiments, the rigid or semi-rigid load-bearing material
comprises a fiber-reinforced material, with the fibers primarily
aligned with the long direction of the composite bar 70.
[0136] Referring now to FIGS. 7A, 7B, and 7C, which show
cross-section cuts through the bar at Section A-A, Section B-B, and
Section B-B, respectively. The orthopedic bar 70 is constructed as
a two-layer, skeleton-type, composite geometry, comprising: a
central cannulation 74, which is initially empty, and which is
surrounded by/defined by a structural, load-bearing body 72 made of
a rigid or semi-rigid load-bearing material (as described above).
FIG. 7B shows an example of a fenestration 76 that fluidically
connects cannulation 74 to the upper surface 75 of body 72. In FIG.
7C, fenestration 76 does not show up.
[0137] Next, in FIGS. 8A, 8B, and 8C, a bone growth mixture 78 (as
described previously, comprising stem cells, particles of allograft
or autograft bone, etc.) has been placed or injected into
cannulation 74. The mixture 78 flows up through fenestration 76
(which can have a diameter small enough that capillary forces can
drive the motion of fluid 78 from cannulation 74 onto upper surface
75. Once the mixture 78 has reached the upper surface 75, it can
flow across the surface, as depicted in FIG. 8B.
[0138] Finally, as shown in FIGS. 9A, 9B, and 9C, after a
sufficient amount of time, bone growth mixture 78 has transformed
into consolidated, living bone tissue 80, which has formed a
uniform, outer layer 82 of living bone 80 covering the top side 75
of body 72, and connected to an inner layer 80 of living bone
inside of cannulation 74 and fenestration 76.
[0139] In some of these embodiments of orthopedic bar 70, the
composite configuration may comprise about 50% allograft and/or
autograft bone, and about 50% metal or metal alloy. In other
embodiments, each layer (core, middle, and outer) has approximately
the same thickness as the other two layers (i.e., 33%, 33%, 33%).
In other embodiments, the thickness of the different layers can be
chosen to be any thickness that provides the necessary and/or
optimum properties for a specific design. In other embodiments, the
"metal or metal alloy" may comprise a titanium alloy,
cobalt-chromium alloy, niobium alloy, tantalum alloy, or a
stainless steel alloy. In another embodiment, the titanium or metal
parts are replaced with carbon or graphite fiber reinforced parts
in similar ratios as described above with the titanium embodiment.
In some embodiments, an antibiotic coating can be applied to any of
the surfaces of orthopedic bar 70.
[0140] FIGS. 10, 11 and 12 illustrate an example of a composite
corpectomy cage, for use in a spinal implant procedure, where an
entire vertebra is replaced with a structural body (i.e.,
corpectomy cage). The composite corpectomy cage 90 is similar to
all of the previously described composite orthopedic devices.
[0141] FIG. 10 shows a cross-section view cut by a vertical plane
passing through the device. This corpectomy cage 90 ("cage")
comprises two, concentric cylinders, 92 and 94, that are engaged by
helical threads. Rotation of an extension ring causes the inner
cylinder 92 (extension tube) to move up or down relative to the
outer cylinder 94. The top (superior) end of the inner cylinder is
attached to the superior plate 96 (which can be a round disc).
Likewise, the lower (inferior) end of the outer cylinder is
attached to the inferior plate 98 (which can also be a round disc).
A pair of composite bone screws, 100, 102, (according to the
present invention) pass through the superior and inferior plates,
96 and 98, at roughly 45 degrees to the horizontal, respectively,
and engage the vertebra bones above and below the cage,
respectively. Each screw securely fastens it's respective plate to
the solid bone of the end-plates of each adjoining vertebra. This
geometry preserves the highly desirable "zero-profile" rule, where
no part of the corpectomy cage protrudes anteriorly or posteriorly
beyond its adjacent vertebra. Extension ring, 114, can be rotated
to cause axial extension (or retraction) of the inner cylinder,
relative to the outer cylinder.
[0142] Referring still to FIG. 10, the thick wall of the outer
cylinder 94 contains the "triple layer" geometry of the present
invention, which comprises a titanium alloy structural body 104
(cylinder) with a plurality of vertically-oriented cannulations 106
(channels) that are open at one or more ends; a plurality of
radially-oriented fenestrations 108, and an outer layer of bone 110
(allograft and/or autograft bone), which can be about 1-2 mm thick.
An antibiotic coating 112 can be disposed on any of the surfaces of
the corpectomy cage 90.
[0143] The lower (inferior) support plate 98 also comprises the
"triple layer" design of the present invention. The plate 98
comprises: a titanium alloy structural body 116 (disc), with a
plurality of radial cannulations 118 that pass through the center
of the disc; a plurality of vertically oriented fenestrations 120;
and an outer layer of bone 122 (allograft and/or autograft bone),
which can be about 1-2 mm thick. In a similar fashion (but not
illustrated), the inner extension tube 92 and the superior support
plate 96 can also be constructed of the "triple layer" geometry of
the present invention.
[0144] In certain embodiments, the corpectomy cage 90 may be
constructed of a material comprising about 50% allograft and/or
autograft bone and about 50% metal or metal alloy. In various
embodiments, the metal or metal alloy may be titanium alloy,
cobalt-chromium, niobium alloy, or tantalum alloy. The allograft
and/or autograft bone may be cancellous or cortical bone. In
another embodiment, the corpectomy cage is coated with an
antibiotic solution. In another embodiment, the fenestration may be
filled with stem cells. In various embodiments the fenestration may
be filled with allograft and/or autograft bone. In another
embodiment, the titanium alloy structural parts are replaced with
carbon or graphite fiber reinforced parts in similar ratios as
described above with the titanium embodiment.
[0145] FIG. 11 shows an isometric view of the inferior support
plate 98 (corpectomy base), attached to the outer corpectomy tube
94 (cylinder). In this view, the radial cannulations 118 and the
vertical fenestrations 120 of the circular support base 98 can be
seen. Also, in this view, the vertical cannulations 106 and the
radial fenestrations 108 of the outer corpectomy tube 94 can be
seen. The outer layer of bone is not shown, so that the underlying
pattern of fenestration holes can be more easily visualized. An
example of an optional vertical slot 124 is illustrated, which is
cut through the wall of the outer tube (cylinder). This slot (which
can comprise 2-8 slots, for example), allows for (1) a
lighter-weight device, and (2) for direct fluid communication
between the inside and outside volumes of the tube (e.g., to
enhance bone graft growth and densification). Alternatively,
optional large-diameter (e.g., 10 mm dia.) through-holes can be
drilled in place of the optional vertical slots 124.
[0146] FIG. 12 shows an isometric, cutaway view of the outer
corpectomy tube 94 (cylinder), showing the vertical cannulations
106 disposed inside of a titanium alloy structural body 104
(cylinder); a plurality of radial fenestrations 108, optionally
passing completely through (109) the sidewall of the cylinder and
into the internal threads 126; the outer layer of bone 110; and
antibiotic coating(s) 112.
Other Methods
[0147] In various embodiments, the present invention provides a
method of using a composite bone screw in a surgical procedure
comprising; providing a composite bone screw as described above;
and inserting said composite bone screw into a bone.
[0148] In various embodiments, the present invention provides a
method of using a composite rod, bar, strip, or cross-link member
in a surgical procedure comprising; providing a composite rod, bar,
strip, or cross-link member as described above; and fastening the
composite rod, bar, strip, or cross-link member to a bone.
[0149] In various embodiments, the present invention provides a
method of using a composite plate in a surgical procedure
comprising; providing a composite plate as described above; and
fastening the composite plate to a bone.
[0150] In various embodiments, the present invention provides a
method of using a composite spinal fusion interbody spacer in a
surgical procedure comprising; providing a composite spinal fusion
interbody spacer as described above; and fastening the composite
spinal fusion interbody spacer to a bone, generally in the space
in-between two adjacent vertebra when a disc has been removed.
Other Embodiments
[0151] The detailed description set-forth above is provided to aid
those skilled in the art in practicing the present invention.
However, the invention described and claimed herein is not to be
limited in scope by the specific embodiments herein disclosed
because these embodiments are intended as illustration of several
aspects of the invention. Any equivalent embodiments are intended
to be within the scope of this invention. Indeed, various
modifications of the invention in addition to those shown and
described herein will become apparent to those skilled in the art
from the foregoing description, which do not depart from the spirit
or scope of the present inventive discovery. Such modifications are
also intended to fall within the scope of the appended claims.
[0152] All references cited in this specification are hereby
incorporated by reference. The discussion of the references herein
is intended merely to summarize the assertions made by their
authors and no admission is made that any reference constitutes
prior art relevant to patentability. Applicant reserves the right
to challenge the accuracy and pertinence of the cited
references.
Descriptive Trademarks
[0153] For purposes of establishing descriptive Trademarks, the
Inventor herein has provided lists of desirable Trademarked
orthopedic devices in Tables 1, 2, and 3 for use with the
orthopedic devices and methods of the present invention, as
follows:
TABLE-US-00001 TABLE 1 Kaloostian .TM. Trademarked Orthopedic
Devices Orthopedic Device Trademark-1 Trademark-2 Trademark-3
Composite Bone Kaloostian .TM. K .TM.-BoneScrew Kal .TM.- Screw
BoneScrew BoneScrew Polyaxial Composite Kaloostian .TM. K
.TM.-PolyScrew Kal .TM.-PolyScrew Bone Screw PolyScrew Composite
Set Screw Kaloostian .TM. K .TM.-SetScrew Kal .TM.-SetScrew
SetScrew Composite Rod Kaloostian .TM. Rod K .TM.-Rod Kal .TM.-Rod
Composite Plate Kaloostian .TM. Plate K .TM.- Plate Kal .TM.- Plate
Composite Bar Kaloostian .TM. Bar K .TM.-Bar Kal .TM.-Bar Composite
Crosslink Kaloostian .TM. Crosslink K .TM.-Crosslink Kal
.TM.-Crosslink Composite Tube Kaloostian .TM. Tube K .TM.-Tube Kal
.TM.-Tube Composite Disc Kaloostian .TM. Disc K .TM.-Disc Kal
.TM.-Disc Composite Interbody Kaloostian .TM. Interbody K .TM.-
Interbody Kal .TM.- Interbody Composite Kaloostian .TM. K
.TM.-Corpectomy Kal .TM.- Corpectomy Cage Corpectomy Cage Cage
Corpectomy Cage
TABLE-US-00002 TABLE 2 Kaloostian .TM. Trademarked Carbon Fiber
Technology Orthopedic Devices Carbon Fiber Technology Orthopedic
Device Trademark-1 Trademark-2 Trademark-3 Composite Bone
Kaloostian .TM. Carbon K .TM.-CF BoneScrew Kal .TM.-CF Screw Fiber
Screw BoneScrew Polyaxial Composite Kaloostian .TM. Carbon K
.TM.-CF PolyScrew Kal .TM.-CF Bone Screw Fiber PolyScrew PolyScrew
Composite Set Screw Kaloostian .TM. Carbon K .TM.-CF SetScrew Kal
.TM.-CF SetScrew Fiber SetScrew Composite Rod Kaloostian .TM.
Carbon K .TM.-CF Rod Kal .TM.-CF Rod Fiber Rod Composite Plate
Kaloostian .TM. Carbon K .TM.- CF Plate Kal .TM.-CF Plate Fiber
Plate Composite Bar Kaloostian .TM. Carbon K .TM.-CF Bar Kal
.TM.-CF Bar Fiber Bar Composite Crosslink Kaloostian .TM. Carbon K
.TM.-CF Crosslink Kal .TM.-CF Crosslink Fiber Crosslink Composite
Tube Kaloostian .TM. Carbon K .TM.-CF Tube Kal .TM.-CF Tube Fiber
Tube Composite Disc Kaloostian .TM. Carbon K .TM.-CF Disc Kal
.TM.-CF Disc Fiber Disc Composite Interbody Kaloostian .TM. Carbon
K .TM.- CF Interbody Kal .TM.- CF Interbody Fiber Interbody
Composite Kaloostian .TM. Carbon K .TM.-CF Kal .TM.-CF Corpectomy
Cage Fiber Corpectomy Cage Corpectomy Cage Corpectomy Cage
TABLE-US-00003 TABLE 3 Kaloostian .TM. Trademarked Pulsed
Radiofrequency Stimulation (RFS) Technology Orthopedic Devices
Pulsed Radiofrequency Stimulation (RFS) Technology Orthopedic
Device Trademark-1 Trademark-2 Trademark-3 Composite Kaloostian
.TM. K .TM.-RFS Kal .TM.-RFS Bone Screw Radiofrequency BoneScrew
BoneScrew Stimulation Screw Polyaxial Composite Kaloostian .TM. K
.TM.-RFS Kal .TM.-RFS Bone Screw Radiofrequency PolyScrew PolyScrew
Stimulation PolyScrew Composite Set Screw Kaloostian .TM. K
.TM.-RFS Kal .TM.-RFS Radiofrequency SetScrew SetScrew Stimulation
SetScrew Composite Rod Kaloostian .TM. K .TM.-RFS Rod Kal .TM.-RFS
Radiofrequency Rod Stimulation Rod Composite Plate Kaloostian .TM.
K .TM.- RFS Kal .TM.-RFS Radiofrequency Plate Plate Stimulation
Plate Composite Bar Kaloostian .TM. K .TM.-RFS Bar Kal .TM.-RFS
Radiofrequency Bar Stimulation Bar Composite Crosslink Kaloostian
.TM. K .TM.-RFS Kal .TM.-RFS Radiofrequency Crosslink Crosslink
Stimulation Crosslink Composite Tube Kaloostian .TM. K .TM.-RFS Kal
.TM.-RFS Radiofrequency Tube Tube Stimulation Tube Composite Disc
Kaloostian .TM. K .TM.-RFS Disc Kal .TM.-RFS Radiofrequency Disc
Stimulation Disc Composite Interbody Kaloostian .TM. K .TM.- RFS
Kal .TM.- RFS Radiofrequency Interbody Interbody Stimulation
Interbody Composite Kaloostian .TM. K .TM.-RFS Kal .TM.-RFS
Corpectomy Cage Radiofrequency Corpectomy Corpectomy Stimulation
Cage Cage Corpectomy Cage
* * * * *