U.S. patent application number 16/663396 was filed with the patent office on 2020-02-20 for intrabody osteotomy implant and methods of use.
The applicant listed for this patent is Warsaw Orthopedic, Inc.. Invention is credited to Rodney Ray Ballard, David A. Mire.
Application Number | 20200054460 16/663396 |
Document ID | / |
Family ID | 65994746 |
Filed Date | 2020-02-20 |
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United States Patent
Application |
20200054460 |
Kind Code |
A1 |
Ballard; Rodney Ray ; et
al. |
February 20, 2020 |
Intrabody Osteotomy Implant and Methods of Use
Abstract
Methods for surgically adjusting a curvature of a spine are
disclosed. The methods provide for controlling the alignment of
bony structures, such as vertebral bodies or portions thereof, as
they are moved relative to one another during a surgical procedure.
An intrabody implant disclosed and methods of use are also
disclosed. The implant has an inclined surface, forming a wedge or
other shape having, for example, an acute angle adapted to be
placed between at least two separated portions of a single bony
structure (such as a vertebral body). In some embodiments, the
implant may be used to support portions of a vertebral body that
have been separated surgically as part of a pedicle subtraction
osteotomy and to orient the portions at a more predictable lordotic
angle.
Inventors: |
Ballard; Rodney Ray;
(Lakeland, TN) ; Mire; David A.; (Cordova,
TN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Warsaw Orthopedic, Inc. |
Warsaw |
IN |
US |
|
|
Family ID: |
65994746 |
Appl. No.: |
16/663396 |
Filed: |
October 25, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15727086 |
Oct 6, 2017 |
10492917 |
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16663396 |
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15262680 |
Sep 12, 2016 |
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15727086 |
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14037737 |
Sep 26, 2013 |
9456856 |
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15262680 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2310/00359
20130101; A61F 2220/0016 20130101; A61F 2002/30266 20130101; A61F
2/44 20130101; A61F 2310/00017 20130101; A61F 2310/00023 20130101;
A61F 2310/00029 20130101; A61F 2230/0015 20130101; A61F 2310/00293
20130101; A61B 17/708 20130101; A61F 2002/3093 20130101; A61F
2210/0014 20130101; A61F 2/4465 20130101; A61F 2002/30593 20130101;
A61F 2002/30836 20130101; A61F 2002/3023 20130101; A61F 2310/00329
20130101; A61F 2/30 20130101; A61F 2310/00371 20130101; A61F
2002/4629 20130101; A61B 17/7083 20130101; A61B 17/7085 20130101;
A61B 17/8095 20130101; A61B 17/7001 20130101; A61F 2/30767
20130101; A61F 2002/30032 20130101; A61B 17/7032 20130101 |
International
Class: |
A61F 2/44 20060101
A61F002/44; A61F 2/30 20060101 A61F002/30; A61B 17/70 20060101
A61B017/70; A61B 17/80 20060101 A61B017/80 |
Claims
1. (canceled)
2. A system comprising: an intrabody implant adapted to be placed
between at least two separated portions of a single bony structure,
the intrabody implant comprising: a first surface configured for
engaging a first vertebra, a second surface opposite the first
surface configured for engaging a second vertebra, and a wall
disposed from the first surface to the second surface, the wall
comprising extending along a longitudinal axis between an anterior
portion and a posterior portion, the posterior portion having a
maximum height that is less than a maximum height of the anterior
portion, the posterior portion of the wall comprising an outer
concave surface, the anterior portion of the wall comprising an
outer convex surface, the posterior portion of the wall defining a
convex profile from the first surface to the second surface, the
posterior portion comprising a threaded bore that extends parallel
to the longitudinal axis through opposite inner and outer surfaces
of the wall such that the bore is positioned between the first and
second surfaces, a first and a second pedicle screw each comprising
at least one head, and a third and a fourth pedicle screw each
comprising at least one head, wherein each head comprises spaced
apart arms that define a U-shaped implant cavity therebetween
configured for disposal of a rod, and a first rod configured to
connect the first and second pedicle screws; and a second rod
configured to connect the first, second, third, and fourth pedicle
screws.
3. The system as recited in claim 1, wherein the first and second
surfaces of the intrabody implant comprise columns of teeth,
adjacent columns being spaced apart from one another by a gap that
extends parallel to the longitudinal axis, the teeth each having a
substantially right-triangular profile, the teeth being sloped
upwards toward the anterior portion.
4. The system as recited in claim 1, wherein the first and second
surfaces of the intrabody implant define an aperture extending
through the implant to allow for bone growth through the implant
from the first portion of the bony structure to the second portion
of the bony structure.
5. The system as recited in claim 1, wherein the second surface of
the intrabody implant is disposed at an acute angle relative to the
first surface of the intrabody implant.
6. The system as recited in claim 4, wherein the posterior height
is less than the anterior height such that the acute angle of the
intrabody implant introduces a lordotic angle between the first and
second portions of the bony structure.
7. The system as recited in claim 5, wherein: the posterior portion
of the wall of the intrabody implant comprises an outer concave
surface configured to conform to a posterior anatomy of the bony
structure; and the anterior portion of the wall of the intrabody
implant comprises an outer convex surface configured to conform to
an anterior anatomy of the bony structure.
8. The system as recited in claim 6, wherein the teeth each have a
substantially right-triangular profile, the teeth being sloped
upwards toward the anterior portion.
9. The system as recited in claim 4, wherein the acute angle is
between 10 degrees and 30 degrees.
10. The system as recited in claim 8, wherein the acute angle is
between 15 degrees and 25 degrees.
11. The system as recited in claim 1, wherein the intrabody implant
includes a width extending parallel to the anterior portion and the
posterior portion, the width being at least 40 mm.
12. The system as recited in claim 1, wherein the first and second
pedicle screws are dual headed screws and the first rod is
configured to connect a first head of the first pedicle screw with
a first head of the second pedicle screw.
13. The system as recited in claim 11, wherein the second rod is
configured to connect a second head of the first pedicle screw with
a second head of the second pedicle screw.
14. The system as recited in claim 1, wherein the intrabody implant
is formed entirely of PEEK polymer.
15. The system as recited in claim 13, wherein the intrabody
implant further comprises a coating of titanium applied to the
first and second surfaces.
16. The system as recited in claim 1, wherein the intrabody implant
is formed entirely of bone material.
17. The system as recited in claim 1, wherein the wall of the
intrabody implant has no projections or surface features.
18. The system as recited in claim 16, wherein the intrabody
implant comprises a coating applied to one or more of the first and
second surfaces and the wall to encourage bone growth onto the
intrabody implant, the coating comprising a material selected from
a group consisting of gold, titanium, hydroxyapatite and
combinations thereof.
19. The system as recited in claim 17, wherein the intrabody
implant comprises a coating applied to one or more of the first and
second surfaces and the wall to encourage bone growth onto the
implant.
20. A kit comprising: an intrabody implant adapted to be placed
between at least two separated portions of a single bony structure,
the intrabody implant comprising: a first surface configured for
engaging a first vertebra, a second surface opposite the first
surface configured for engaging a second vertebra, and a wall
disposed from the first surface to the second surface, the wall
comprising extending along a longitudinal axis between an anterior
portion and a posterior portion, the posterior portion having a
maximum height that is less than a maximum height of the anterior
portion, the posterior portion of the wall comprising an outer
concave surface, the anterior portion of the wall comprising an
outer convex surface, the posterior portion of the wall defining a
convex profile from the first surface to the second surface, the
posterior portion comprising a threaded bore that extends parallel
to the longitudinal axis through opposite inner and outer surfaces
of the wall such that the bore is positioned between the first and
second surfaces, wherein the first and second surfaces implant
comprise columns of teeth, adjacent columns being spaced apart from
one another by a gap that extends parallel to the longitudinal
axis, the teeth each having a substantially right-triangular
profile, the teeth being sloped upwards toward the anterior
portion; a first and a second dual-headed pedicle screw each
comprising a first head and a second head, and a third and a fourth
single headed pedicle screw each comprising one head, wherein each
head comprises spaced apart arms that define a U-shaped implant
cavity therebetween configured for disposal of a rod, and a first
rod configured to connect the first and second pedicle screws using
the first head of each of the first and second dual-headed pedicle
screws; and a second rod configured to connect the first, second,
third, and fourth pedicle screw using the second head of each of
the first and second dual-headed pedicle screws and the one head of
each of the third and fourth single headed pedicle screws.
21. A kit comprising: an intrabody implant adapted to be placed
between at least two separated portions of a single bony structure,
the intrabody implant comprising: a first surface configured for
engaging a first vertebra, a second surface opposite the first
surface configured for engaging a second vertebra, wherein the
second surface is disposed at an acute angle relative to the first
surface, and a wall disposed from the first surface to the second
surface, the wall comprising extending along a longitudinal axis
between an anterior portion and a posterior portion, the posterior
portion having a maximum height that is less than a maximum height
of the anterior portion, the posterior portion of the wall
comprising an outer concave surface, the anterior portion of the
wall comprising an outer convex surface, the posterior portion of
the wall defining a convex profile from the first surface to the
second surface, the posterior portion comprising a threaded bore
that extends parallel to the longitudinal axis through opposite
inner and outer surfaces of the wall such that the bore is
positioned between the first and second surfaces; a first and a
second dual-headed pedicle screw each comprising a first head and a
second head, and a third and a fourth single headed pedicle screw
each comprising at least one head, wherein each head comprises
spaced apart arms that define a U-shaped implant cavity
therebetween configured for disposal of a rod, and a first rod
configured to connect the first and second pedicle screws using the
first head of each of the first and second dual-headed pedicle
screws; and a second rod configured to connect the first, second,
third, and fourth pedicle screw using the second head of each of
the first and second dual-headed pedicle screws and one head of
each of the third and fourth single headed pedicle screws.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation of U.S. patent
application Ser. No. 15/727,086 filed Oct. 6, 2017, which is a
Continuation in part of U.S. patent application Ser. No. 15/262,680
filed Sep. 12, 2016, now Abandoned, which is a Division of U.S.
patent application Ser. No. 14/037,737 filed Sep. 26, 2013, now
U.S. Pat. No. 9,456,856, the disclosures of each of the
above-identified applications are hereby incorporated by reference
in their entirety.
TECHNICAL FIELD
[0002] The present disclosure generally relates to medical devices,
systems and methods for the treatment of musculoskeletal disorders,
and more particularly, to an intrabody implant and methods for
fusing portions of one or more vertebral bodies to achieve a
desired spinal curvature and/or angulation.
BACKGROUND
[0003] Spinal disorders such as degenerative disc disease, disc
herniation, osteoporosis, spondylolisthesis, stenosis, scoliosis
and other curvature abnormalities, kyphosis, tumor, and fracture
may result from factors including trauma, disease and degenerative
conditions caused by injury and aging. Spinal disorders typically
result in symptoms including pain, nerve damage, and partial or
complete loss of mobility. For example, after a disc collapse,
severe pain and discomfort can occur due to the pressure exerted on
nerves and the spinal column.
[0004] Non-surgical treatments, such as medication, rehabilitation
and exercise can be effective, however, may fail to relieve the
symptoms associated with these disorders. Surgical treatment of
these spinal disorders includes fusion, fixation, discectomy, lam
inectomy, osteotomy and implantable prosthetics. These treatments
may employ spinal implants and, in some cases, the placement of
interbody implants via a variety of invasive, partially invasive
and/or minimally invasive surgical pathways. Furthermore, in spinal
disorders wherein a patient has an abnormal spinal curvature,
surgeons may perform a complete and/or partial osteotomy to remove
bony structures from the spine in order to reorient the bones of
the spine to provide the patient with a desired spinal curvature.
In many cases, however, there is difficulty in providing an
accurate kyphotic and/or lordotic angle when performing osteotomy.
Various factors contribute to this difficulty, including, but not
limited to: the challenge of cutting a wedge-shaped aperture in the
spinal anatomy having a precise slope; and the breakdown or
subsidence of the remaining bony portions after an osteotomy is
performed. This disclosure describes an improvement in these
technologies.
SUMMARY
[0005] Accordingly, methods for surgically adjusting a curvature of
a spine comprising vertebrae are disclosed. Such methods may
include steps of removing a portion of a single vertebral body of
the spine to form two at least partially separated portions of the
vertebral body; inserting a first pedicle screw into a second
vertebral body superior to the single vertebral body and a second
pedicle screw into a third vertebral body inferior to the single
vertebral body, connecting the first pedicle screw and the second
pedicle screw with a rod; and bringing into closer proximity the
two at least partially separated portions of the single vertebral
body such that the first and second pedicle screw advance towards
one another along the rod. The method embodiments may result in the
orientation of the two at least partially separated portions of the
vertebral body at a correction angle relative to one another.
[0006] The method embodiments described herein may provide lordotic
and/or kyphotic correction to a spinal column at the level of the
single vertebral body or across multiple levels, as part of an
osteotomy procedure that may include, but is not limited to, a
pedicle subtraction osteotomy (PSO). The step of bringing into
closer proximity disclosed herein may include bringing the exposed
portions of the screws and/or screw heads in closer proximity
and/or angulating portions of the vertebrae or vertebral portions
such that at least the posterior portions of the vertebrae or
vertebral portions are brought closer together and further may
include securing the two at least partially separated portions of
the single vertebral body relative to one another using an
extradiscal stabilization system. The method may further comprise
repeating any or all of the removing, inserting, connecting steps,
and the bringing into closer proximity the two at least partially
separated portions of the single vertebral body (or alternatively
two different vertebral bodies) step, across one, two, or more
levels of the human spine to achieve an overall spinal correction
across the one or more levels.
[0007] Furthermore, the method may also comprise providing a
wedge-shaped intrabody implant comprising a first surface and a
second surface, the second surface disposed at an acute angle to
the first surface; and placing the wedge-shaped intrabody implant
between the two at least partially separated portions of the single
vertebral body. The method may also further comprise packing the
intrabody implant with bone-growth promotion material (in a bone
growth aperture defined in the intrabody implant, for example). In
some embodiments, the acute angle is between 10 degrees and 30
degrees, or between 15 degrees and 25 degrees.
[0008] In some embodiments, the first pedicle screw is positioned
on a lateral side of spinous processes of the second vertebral
body, and wherein the second pedicle screw is positioned on the
same lateral side of spinous processes of the third vertebral body.
The method may further comprise inserting a third pedicle screw
into the second vertebral body on a lateral side of spinous
processes opposite the first pedicle screw and a fourth pedicle
screw into the third vertebral body on a lateral side of spinous
processes opposite the second pedicle screw, and connecting the
third pedicle screw and the fourth pedicle screw with a second rod.
During the step of bringing into closer proximity the two at least
partially separated portions of the single vertebral body (or
alternatively two different vertebral bodies), the third and fourth
pedicle screw may advance towards one another along the second
rod.
[0009] In some embodiments, the first and second pedicle screws are
dual headed screws and the rod connects a first head of the first
pedicle screw with a first head of the second pedicle screw. The
method may further comprise inserting a third pedicle screw in a
vertebrae superior to the first pedicle screw and a fourth pedicle
screw in a vertebrae inferior to the second pedicle screw, wherein
the step of bringing into closer proximity further comprises
securing the two at least partially separated portions of the
single vertebral body (or multiple different vertebral bodies)
relative to one another by connecting the first, second, third, and
fourth pedicle screws with a second rod. The second rod connects a
second head of the first pedicle screw with a second head of the
second pedicle screw. Alternatively, offset connectors may be
applied or inserted into one or more screw heads to effectively
create multi-headed screws in place of or in addition to the use of
one or more dual-headed screws.
[0010] Also provided is a method for surgically adjusting a
curvature of a spine comprising vertebrae, the method comprising
removing a portion of at least one vertebral body to form an
opening in the spine, inserting a first pedicle screw into a
vertebral body or portion thereof superior to the opening and a
second pedicle screw into a vertebral body or portion thereof
inferior to the opening, connecting the first pedicle screw and the
second pedicle screw with a rod, and bringing into closer proximity
the superior vertebral body or portion thereof and inferior
vertebral body or portion thereof such that the first and second
pedicle screw advance towards one another along the rod. In some
embodiments, the first and second pedicle screws are dual headed
screws and the rod connects a first head of the first pedicle screw
with a first head of the second pedicle screw. The method may
further comprising inserting a third pedicle screw in a vertebrae
superior to the first pedicle screw and a fourth pedicle screw in a
vertebrae inferior to the second pedicle screw, wherein the step of
bringing to closer proximity further comprises securing the
inferior vertebral body or portion thereof to the inferior
vertebral body or portion thereof by connecting the first, second,
third, and fourth pedicle screws with a second rod. In some
embodiments, removing a portion of at least one vertebral body
further comprises removing at least one half of said vertebral
body, and further comprises removing a portion of a vertebral disc
associated with said vertebral body. In some embodiments, the first
pedicle screw is inserted into a vertebral body that is a first
vertebral body and the second pedicle screw is inserted into a
vertebral body that is a second vertebral body such that the
bringing into closer proximity brings a first vertebral body into
closer proximity with a second vertebral body.
[0011] Also disclosed are an intrabody implant and methods of use.
In one embodiment, an intrabody implant is provided for placement
between separated portions of a previously-unitary bony structure,
such as a vertebral body. In one embodiment, the intrabody implant
comprises first and second surfaces for engaging the first and
second portions of the separated bony structure. The surfaces of
the implant may be provided with titanium or other coatings or a
plurality of surface features extending outward from the surfaces
to engage the bony structure. The second implant surface may be
disposed opposite the first implant surface at an acute angle
relative to the first surface. The implant further comprises a wall
disposed between the first and second implant surfaces. The wall
comprises anterior and posterior portions wherein the respective
heights of the posterior and anterior portions are unequal to form
the acute angle. In some embodiments, the implant may be made of
any biocompatible material, such as metal, bone, plastic, coral, or
other artificial or natural substances, and may additionally have
naturally occuring or manufactured porous or roughened surfaces, or
other surface features (for example, teeth or ridges) to facilitate
engagement of the implant with portions of the spine. In some
embodiments, the implant may further include openings for use with
insertion instruments or fixation elements such as screws, nails or
pins or for the further attachment of one or more plates or
tabs.
[0012] Various embodiments of the intrabody implant may define an
aperture extending through the implant to allow for bone growth
through the implant. Furthermore, in some embodiments, the
posterior height of the implant may be less than the anterior
height of the implant such that the acute angle (which may range
widely from 0-90 degrees) introduces a lordotic angle between the
first and second portions of the bony structure when the intrabody
implant is placed therebetween. The intrabody implant portions may
also be formed of a polymer material such as PEEK, and be formed
with a convex posterior portion and a concave anterior portion to
better conform to the anatomy of the separated bony structure. The
implant may also be sized to occupy a substantial width of the bony
structure. For example, a width of the implant may, in some
embodiments, be greater than 40 mm.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] The present disclosure will become more readily apparent
from the specific description accompanied by the following
drawings, in which:
[0014] FIG. 1 is a perspective view of a spine with insufficient
lordosis in the lumbar region.
[0015] FIG. 2 is a perspective view of a spine after the initial
removal of bony material from an osteotomy procedure.
[0016] FIG. 3 is a perspective view of a spine with an intrabody
implant, according to one embodiment.
[0017] FIG. 4 is a perspective view of an intrabody implant,
according to one embodiment.
[0018] FIG. 5 is a side view of an intrabody implant, according to
one embodiment.
[0019] FIG. 6 is a top view of an intrabody implant, according to
one embodiment.
[0020] FIG. 7 is a perspective view of a spine with an intrabody
implant system, according to one embodiment.
[0021] FIG. 8 is a side view of a spine after the initial removal
of bony material from an osteotomy procedure and placement of
pedicle screws.
[0022] FIG. 9 is a side view of a spine with a rod placed in
pedicle screws prior to closure of portions of the spine, according
to one embodiment.
[0023] FIG. 10 is a top view of a spine with a rod placed prior to
closure of portions of the spine, according to one embodiment.
[0024] FIG. 11 is a side view of a spine with a rod placed and
secured prior to closure of portions of the spine, according to one
embodiment.
[0025] FIG. 12 is a top view of a spine with a rod placed and
secured prior to closure of portions of the spine, according to one
embodiment.
[0026] FIG. 13 is a side view of a spine with a rod placed and
secured after closure of portions of the spine, according to one
embodiment.
[0027] FIG. 14 is a top view of a spine with a rod placed and
secured after closure of portions of the spine, according to one
embodiment.
[0028] FIG. 15 is a side view of a spine after closure of portions
of the spine with a stabilization rod secured, according to one
embodiment.
[0029] FIG. 16 is a perspective view of a spine after closure of
portions of the spine with a stabilization rod secured, according
to one embodiment.
DETAILED DESCRIPTION
[0030] The exemplary embodiments of an intrabody implant and
related methods of use disclosed herein are discussed in terms of
medical devices for the treatment of musculoskeletal disorders and
more particularly, in terms of an intrabody implant for placement
after osteotomy and related methods for treating a vertebral
column. It is envisioned that the disclosed intrabody implant and
methods may provide, for example, a means for more accurately
introducing a correction angle to a portion of the spinal column by
virtue of the intrabody implant, which may enable a surgeon to more
precisely predict the closure and/or correction angle despite
variations in wedge angle that may be introduced in the
"bone-on-bone" closure of known osteotomy procedures. In one
embodiment, the wedge design of the intrabody implant may aid in
the maintenance of anterior vertebral body height while allowing
for closure (height collapse) on a posterior portion of the same
vertebral body in order to introduce a corrective angulation.
[0031] The various embodiments described herein may also be
especially useful in maintaining the shape and position of the
vertebral body during and after an osteotomy. For example, in known
osteotomy procedures as a wedge-cut vertebral body (see FIG. 2, for
example) collapses, the anterior portion of the vertebral body (V1,
V2) may also break during closure of the angle .theta.. It may be
difficult for a surgeon to predict any shifts that may occur once
the anterior portion of the vertebral body breaks. Thus, the
intrabody implant 100 (see FIG. 3, for example) may help restrict
any shift in the bony structures V1, V2 remaining after an
osteotomy procedure. Further, a guided closure method (see FIGS.
8-16, for example) may also help restrict or further limit any
shift in the bony structures V1 and V2 remaining after an osteotomy
procedure.
[0032] Referring to FIGS. 1-3, a method for surgically adjusting a
curvature of the spine is provided. In one embodiment, a vertebral
body V is selected for an osteotomy procedure which may include
removing portions of the pedicle P, spinous processes SP and/or
facet joint structures F at the level of the vertebral body V.
While level L3 is depicted in FIG. 1, a surgeon may apply the
procedure described herein to any number of spinal levels in the
lumbar, thoracic, or cervical spine to introduce a corrective
curvature to the spine. In general, the disc and vertebra above and
below the disc comprise one segment of the spine--usually called a
spinal level or spinal segment.
[0033] As shown in FIG. 2, the method may further comprise removing
a wedge-shaped portion of a single vertebral body V (see FIG. 1) to
form two at least partially separated portions V1, V2 of the single
vertebral body V. A surgeon may select and/or measure a corrective
angle .theta. to serve as the basis for this step. However, and as
described further herein, the acute angle .alpha. defined by the
surfaces 110, 120 of the implant 100 (see FIG. 5) may be used to
ensure that the completed spinal surgery results in a desired level
of spinal curvature (see FIG. 3) regardless of the angle .theta. of
the removal cut made by the surgeon as part of the removal step. As
described herein with respect to FIG. 1, the removing step may
comprise a pedicle subtraction osteotomy (PSO) procedure wherein
the pedicle P, spinous process SP, and/or portions of the facet
joint structure F are completely or partially removed from the
vertebral body.
[0034] The method may further comprise providing a wedge-shaped
intrabody implant 100 (as described further herein with respect to
FIGS. 4-6) comprising a first surface 110 and a second surface 120,
wherein the second surface 120 may be disposed at an acute angle
.alpha. to the first surface 110. In some embodiments as shown in
FIG. 4, the intrabody implant 100 may be provided with an aperture
101 extending through the wedge-shaped intrabody implant 100 to
allow for bone growth therethrough. In other embodiments, the
method may further comprise packing the aperture 101 with a
bone-growth promotion material prior to the placing step described
herein with respect to FIG. 3.
[0035] As shown in FIG. 3, the method further comprises placing the
wedge-shaped intrabody implant 100 between the two at least
partially separated portions V1, V2 of the single vertebral body V,
and closing or bringing into closer proximity the two at least
partially separated portions V1, V2 of the single vertebral body
about the intrabody implant 100. Therefore, the two at least
partially separated portions V1, V2 of the single vertebral body
are oriented at a correction angle relative to one another.
Preferably, the resulting correction angle may be substantially
predictable based on the selected implant. For example, in some
embodiments, the correction angle may be within a selected number
of degrees of the acute angle defined by the intrabody implant. In
some embodiments, the range of difference between the correction
angle and the acute angle may be relatively wide (i.e. 10-90
degrees). In other embodiments, the range of difference between the
correction angle and the acute angle may be relatively narrow (i.e.
0-10 degrees).
[0036] According to various method embodiments, the correction
angle of the spinal column defined at least in part by the acute
angle .alpha. of the intrabody implant may provide a lordotic
correction to a spinal column at the level of the single vertebral
body V. In other embodiments, the implant direction may be reversed
such that the correction angle of the spinal column defined at
least in part by the acute angle .alpha. of the intrabody implant
may provide a kyphotic correction to a spinal column at the level
of the single vertebral body V. In some embodiments, the various
embodiments of the present invention may provide a correction angle
across multiple levels (such that the acute angles a of several
intrabody implants 100 may provide a lordotic correction to a
spinal column across two or more levels). In such embodiments, the
removing, providing, placing and closing or bringing into closer
proximity steps disclosed herein may be repeated across two or more
levels of the human spine to achieve an overall spinal correction
across the two or more levels.
[0037] In some method embodiments, the closing or bringing into
closer proximity step described herein may further comprise
securing the two at least partially separated portions V1, V2 of
the vertebral body V about the implant 100 using an extradiscal
stabilization system (which may include, for example, a rod 300 and
pedicle screw 201, 202 construct as shown generally in FIGS. 3 and
7. The pedicle screws 201, 202 may be inserted into the pedicles of
adjacent vertebral bodies V3, V4 and connected via rod 300 that may
be shaped and/or bent by the surgeon to further reinforce the
corrective angle sought as part of the surgical procedure. FIG. 7
shows a perspective view of a bi-lateral screw 201, 202, 203, 204
and rod 300, 301 construct that may also be used to reinforce the
corrected spinal curvature using the various methods described
here. Various screw and rod systems may be used for the
reinforcement step, including but not limited to the SOLERA.RTM.
and LEGACY.RTM. extradiscal stabilization systems offered by
Medtronic.RTM. Spine.
[0038] Referring now to FIGS. 8-16, a method for surgically
adjusting a curvature of the spine is provided. In one embodiment,
a vertebral body is selected for an osteotomy procedure and a
portion of the vertebral body is removed to form two at least
partially separated portions of the single vertebral body as
discussed above. The removed portion may be wedge-shaped or any
other suitable shape. Alternatively, as shown in FIG. 8, a wedge
shaped portion of the single vertebral body V1 may be removed
together with an adjacent intervertebral disc, or a portion
thereof, to form a gap in the spine. In such instances, vertebral
body or body portion V1 may contact adjacent vertebral body or body
portion V2 directly in a "bone-on-bone" closure, or a wedge-shaped
or other-shaped intrabody implant may be disposed therebetween as
discussed above. A surgeon may select and/or measure a corrective
angle .theta. to serve as the basis for this step. As described
above with respect to FIGS. 1 and 2, the removing step may comprise
a pedicle subtraction osteotomy (PSO) procedure wherein the pedicle
P, spinous process SP, and/or portions of the facet joint structure
F are completely or partially removed from the vertebral body.
[0039] The method may further comprise the step of inserting
pedicle screws 801 and 802 into vertebrae V2 and V3 adjacent to the
vertebral body selected for the osteotomy procedure, or superior
and inferior to the gap in the spine formed by removal of a
vertebral body, intervertebral disc, or portions, or a combination
thereof. As shown in FIGS. 9 and 10, a rod 900 is placed in heads
of pedicle screws 801 and 802. The rod 900 may be secured with set
screws 811 and 812, as shown in FIGS. 11 and 12, or other closure
mechanisms (for example, wires or plates). In one embodiment of the
invention, pedicle screws 801 and 802 may be dual headed screws,
such as, for example, those disclosed in co-pending application
Ser. No. 15/483,824, incorporated herein in its entirety, and rod
900 may be secured in a first head 801a and 802a of pedicle screws
801 and 802. Second head 801b and 802b of pedicle screws 801 and
802 remain available for securing, e.g., a stabilization rod, as
discussed below. Alternatively, offset connectors may be applied or
inserted into one or more screw heads to effectively create
multi-headed screws in place of or in addition to the use of one or
more dual-headed screws. Rod 900 may help restrict any shift in
bony structures V1 and V2 as portions of the spine come closer
together and the adjacent faces of V1 and V2 are brought towards
one another to the corrected spinal curvature. In some embodiments,
a second set of pedicle screws and rod are placed bilaterally to
pedicle screws 801 and 802 and rod 900 to provide additional
alignment control.
[0040] The method further comprises the step of closing or bringing
into closer proximity the at least partially separated portions of
the single vertebral body such that the first and second pedicle
screw advance towards one another along the rod. In this manner,
the alignment of the spine is ensured and subluxation of the
vertebrae is reduced or prevented. Set screws 811 and 812 or other
closure mechanisms securing rod 900 into pedicle screws 801 and 802
may be selectively tightened and loosened during this step to
control the advancement towards, or distance between, the pedicle
screws as the bony structures V1 and V2 are brought towards one
another. Bony structures V1 and V2 may be brought towards one
another using any standard means or devices as known by one of
ordinary skill in the art. For example, a pedicle subtraction
osteotomy may be performed on a hinged operating table with the
ends of the table slightly below the hinge at the start of the
procedure. During closure of the spine, the hinged table may be
flattened, thereby bringing bony structures V1 and V2 towards one
another.
[0041] A surgeon may also use any other means, tool, or apparatus
to adjust the distance between the bony structures V1 and V2 and/or
pedicle screws 801 and 802, including, but not limited to,
distractors, compressors, extenders, or controllers. For example,
it may be necessary to adjust the distance between bony structures
V1 and V2 independently from pedicle screws 801 and 802 in order to
adjust the angle of the adjacent faces of V1 and V2. By using a
combination of tightening and loosening set screws 811 and 812, or
other closure mechanisms securing rod 900 in pedicle screws 801 and
802, such as distractors, compressors, extenders, controllers,
and/or other tools as may be known to those of ordinary skill in
the art, a surgeon may adjust the distance between pedicle screws
801 and 802 along rod 900, either increasing, decreasing, or
maintaining the distance, while moving adjacent faces V1 and V2.
Distractors known in the art may be used, e.g., to hold pedicle
screws 801 and 802 apart as portions of the spine are manipulated,
Compressors known in the art may further be used, e.g., to bring
pedicle screws 801 and 802 closer together as portions of the spine
are manipulated. Exemplary tools, e.g., compressors and
distractors, are disclosed in, e.g., U.S. Pat. No. 7,686,814,
incorporated herein by reference in its entirety. Extenders may be
attached to, e.g., pedicle screws 801 or 802 and may alter the
distance and/or relative orientation therebetween in order to ease
connection to rod 900 or other spinal rods, or to provide
additional means for interaction. Exemplary extenders are disclosed
in, e.g., U.S. Pat. Nos. 8,663,289, 8,727,972, and 8,828,059, all
incorporated herein by reference in their entirety. A controller
that may be, e.g., secured to pedicle screws 801 and 802 and may be
used to selectively apply compression or distraction forces thereto
is disclosed in, e.g., U.S. Pat. No. 9,402,660, incorporated herein
by reference in its entirety.
[0042] Referring now to FIGS. 13 and 14, the spine has been closed
and adjacent faces of bony structures V1 and V2 have been brought
into "bone-on-bone" contact. In comparison with FIGS. 9-12, the
distance between pedicle screws 801 and 802 is decreased due to
advancement towards one another along rod 900. In this manner, the
alignment of the spine is improved and subluxation of the vertebrae
reduced or prevented during closure of, or bringing into closer
proximity, portions of the spine.
[0043] In some method embodiments, the closing or bringing into
closer proximity step described herein may further comprise
securing a corrected spinal curvature using an extradiscal
stabilization system (which may include, for example, a
stabilization rod 1000 and pedicle screws 801, 802, 803, and 804 as
shown generally in FIGS. 15 and 16). Pedicle screws 803 and 804 may
be inserted into the pedicles of adjacent vertebral bodies V4, V5
and connected via stabilization rod 1000. Rod 1000 may be shaped
and/or bent as desired to further reinforce the corrective angle
sought as part of the surgical procedure. FIG. 15 shows a side view
of a construct comprising pedicle screws 801, 802, 803, 804, rod
900, and stabilization rod 1000, which may also be used to
reinforce the corrected or adjusted spinal curvature using the
various methods described here, while FIG. 16 shows a perspective
view of the construct with stabilization rod inserted into second
heads 801b and 802b of pedicle screws 801 and 802. Various screw
and rod systems may be used for the reinforcement step, including
but not limited to the SOLERA.RTM. and LEGACY.RTM. extradiscal
stabilization systems offered by Medtronic.RTM. Spine.
[0044] Referring now to FIGS. 3-6, an intrabody implant 100 is
disclosed for placement between at least two separated portions V1,
V2 of a bony structure such as a vertebral body V. The implant 100
may be formed in whole or in part from a variety of biocompatible
materials suitable for long-term implantation. For example, the
implant 100 may be preferably formed of a polymer such as PEEK.
[0045] The components of implant 100 can be fabricated from a
variety of biologically acceptable materials suitable for medical
applications, including metals, synthetic polymers, ceramics and
bone material and/or their composites, depending on the particular
application and/or preference of a medical practitioner. For
example, the components of implant 100, individually or
collectively, can be fabricated from materials such as stainless
steel alloys, commercially pure titanium, titanium alloys, Grade 5
titanium, super-elastic titanium alloys, cobalt-chrome alloys,
stainless steel alloys, superelastic metallic alloys (e.g.,
Nitinol, super elasto-plastic metals, such as GUM METAL.RTM.
manufactured by Toyota Material Incorporated of Japan), ceramics
and composites thereof such as calcium phosphate (e.g., SKELITE.TM.
manufactured by Biologix Inc.), thermoplastics such as
polyaryletherketone (PAEK) including polyetheretherketone (PEEK),
polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEK
composites, PEEK-BaSO.sub.4 polymeric rubbers, polyethylene
terephthalate (PET), fabric, silicone, polyurethane,
silicone-polyurethane copolymers, polymeric rubbers, polyolefin
rubbers, hydrogels, semi-rigid and rigid materials, elastomers,
rubbers, thermoplastic elastomers, thermoset elastomers,
elastomeric composites, rigid polymers including polyphenylene,
polyamide, polyimide, polyetherimide, polyethylene, epoxy, bone
material including autograft, allograft, xenograft or transgenic
cortical and/or corticocancellous bone, and tissue growth or
differentiation factors, partially resorbable materials, such as,
for example, composites of metals and calcium-based ceramics,
composites of PEEK and calcium based ceramics, composites of PEEK
with resorbable polymers, totally resorbable materials, such as,
for example, calcium based ceramics such as calcium phosphate such
as hydroxyapatite (HA), corraline HA, biphasic calcium phosphate,
tricalcium phosphate, or fluorapatite, tri-calcium phosphate (TCP),
HA-TCP, calcium sulfate, or other resorbable polymers such as
polyaetide, polyglycolide, polytyrosine carbonate, polycaroplaetohe
and their combinations, biocompatible ceramics, mineralized
collagen, bioactive glasses, porous metals, bone particles, bone
fibers, morselized bone chips, bone morphogenetic proteins (BMP),
such as BMP-2, BMP-4, BMP-7, rhBMP-2, or rhBMP-7, demineralized
bone matrix (DBM), transforming growth factors (TGF, e.g.,
TGF-.beta.), osteoblast cells, growth and differentiation factor
(GDF), insulin-like growth factor 1, platelet-derived growth
factor, fibroblast growth factor, or any combination thereof.
[0046] According to the various embodiments provided herein, the
implant 100 may comprise a first surface 110 configured for
engaging a first V1 of the at least two separated portions of the
bony structure. The implant 100 further comprises a second surface
120, disposed opposite the first surface 110, and configured for
engaging a second V2 of the at least two separated portions of the
bony structure. As shown in FIG. 5, the first and second surfaces
110, 120 may be disposed at an acute angle .alpha. relative to one
another. The angle .alpha. may range widely from zero to 90
degrees. However, in some preferable embodiments the angle .alpha.
may range from 10 to 30 degrees. In other more preferable
embodiments, the angle .alpha. may range from 15 to 25 degrees.
[0047] As shown in FIGS. 4 and 5, the implant 100 may further
comprise a wall 150 disposed between the first and second surfaces
110, 120. The wall 150 comprises an anterior portion 130 and a
posterior portion 140. As shown in FIG. 5, the posterior portion
140 has a posterior height and the anterior portion 130 has an
anterior height, wherein the posterior and anterior heights are
unequal to form the preferably acute angle .alpha. between the
first surface 110 and the second surface 120 of the implant 100. In
some embodiments, as shown in FIG. 5, the posterior height may be
less than the anterior height such that the angle .alpha. of the
implant 100 introduces a lordotic angle between the first and
second portions V1, V2 of the bony structure V (see FIG. 3, for
example). Furthermore, as shown in FIG. 5, the posterior portion
140 and/or anterior portion 130 of the implant may be provided with
a convex profile between the first and second surfaces 110, 120 to
aid in the ease of insertion of the implant 100. The profile may
also, in alternate embodiments, be chamfered and/or provided with
edge radii to allow for easier insertion of the implant 100 from
either the posterior or anterior directions.
[0048] FIG. 6 shows a top view of an implant 100 according to one
embodiment wherein the first and second surfaces 110, 120 define an
aperture 101 extending through the implant 100 to allow for bone
growth through the implant 100 from the first portion V1 of the
bony structure V to the second portion V2 (see FIG. 3, for
example). The aperture 101 may also be packed with bone growth
promoting material, including but not limited to bone allograft,
bone xenograft, bone autograft, bone morphogenetic protein (BMP)
and/or combinations thereof. Furthermore, as shown in FIG. 6, the
implant 100 may be formed in a shape that conforms to the anatomy
of the human spine. For example, the posterior portion 140 of the
wall 150 may comprise an outer concave surface configured to
conform to a posterior anatomy of the bony structure V.
Furthermore, the anterior portion 130 of the wall 150 may comprise
an outer convex surface configured to conform to an anterior
anatomy of the bony structure V.
[0049] Referring again to FIG. 6, the implant 100 may include a
width W extending substantially parallel to the anterior portion
130 and the posterior portion 140. The width W of the implant 100
may be chosen to substantially fill the width of the vertebral body
V or other bony structure where the intrabody is intended to be
placed after osteotomy. For example, in some embodiments, the width
W may be at least 40 mm. In other embodiments, the width W may be
at least 50 mm (when used, for example, in the lower lumbar
region). In other embodiments, the width W may be tailored for use
in smaller vertebral bodies (for example, in smaller patients or in
the upper thoracic or cervical spine). In some such embodiments,
the width W may be in the range of 15-40 mm (or 25-30 mm in some
preferable cervical and thoracic embodiments). The depth of the
implant 100 may also vary accordingly (wherein the depth is
measured perpendicular to the width W from the anterior portion 130
to the posterior portion 140). In some embodiments, the depth may
range from 10 mm to 50 mm (and preferably from 15-20 mm in certain
embodiments).
[0050] As shown in FIGS. 4 and 6, the first surface 110 and second
surface 120 of the implant 100 may further comprise a plurality of
surface features 112 extending outward from the surfaces 110, 120
to engage a complementary surface of the bony structure V. For
example, the surface features 112 may include, but are not limited
to: ridges, teeth, pyramidal structures, roughened irregular
projections and/or combinations thereof. The surface features 112
may be optimized in shape and/or directional orientation to resist
the expulsion of the implant 100 from between the portions V1, V2
of the bony structure when the patient applies weight forces to the
spine during the course of standing or movement. For example, the
surface features 112, may comprise rows of teeth (see FIG. 5)
having a substantially right-triangular profile wherein the teeth
are sloped upwards towards the anterior portion 130 of the wall 150
of the implant 100. In other embodiments, the implant 100 may
further comprise a coating applied to one or more of the surfaces
110, 120 and/or the wall 150 to encourage bone growth onto the
implant 100. Such coatings may include, but are not limited to:
gold, titanium, hydroxyapatite (HA) and/or combinations thereof.
The coatings may be applied with a roughened texture so as to
provide a plurality of irregular projections that may serve as
surface features 112 to also resist expulsion of the implant 100
after implantation. In other embodiments, the implant 100 may have
substantially smooth surfaces 110, 120 and wall 150 having no
projections or surface features.
[0051] In other embodiments, the implant 100 may, for example, be
expandable in a number of ways, including by, e.g., sliding wedge,
turnbuckle, ratchet, hinge, expandable balloon, ratchets, stackable
implants, vaneers slid inside the implant top and bottom like
shims, via the use of springs, or via telescoping designs.
Exemplary expandable implants and methods of their use are
disclosed in, e.g., U.S. patent application Ser. Nos. 14/885,472,
15/008,805, and, 15/009,582, and U.S. Pat. Nos. 7,118,579,
7,655,027, 7,922,729, and 8,771,321, all incorporated herein by
reference in their entirety. Once expanded, graft and/or other bone
growth promoting material inserted into the implant by various
cannula, tubing, syringes, tamps, or other mechanisms as known to
those of ordinary skill in the art. An exemplary graft and/or bone
growth material delivery device is disclosed in, e.g., U.S. Pat.
No. 8,092,464, incorporated herein by reference in its
entirety.
[0052] It will be understood that various modifications may be made
to the embodiments disclosed herein. Therefore, the above
description should not be construed as limiting, but merely as
exemplification of the various embodiments. Those skilled in the
art will envision other modifications within the scope and spirit
of the claims appended hereto.
* * * * *