Note: Descriptions are shown in the official language in which they were submitted.
PATIENT-MATCIIED APPARATUS AND METHODS
FOR PERFORMING SURGICAL PROCEDURES
FIELD OF THE INVENTION
The present disclosure relates to the field of medical devices and is
generally
directed toward apparatus configurable for use with a specific patient in a
surgical setting
based on the patient's unique anatomical features, and methods of
manufacturing and using
the same.
BACKGROUND OF THE INVENTION
Given the complexities of surgical procedures and the various tools,
instruments,
implants and other devices used in the procedures, as well as the varying
anatomical
differentiation between patients who receive those tools, instruments,
implants and devices,
it is often challenging to create a surgery plan that accounts for the unique
and sometimes
irregular anatomical features of a particular patient. For example, the
implantation of
pedicle screws in a vertebral body (as an adjunct or stand-alone stabilization
mechanism) is
well accepted amongst surgeons who treat various spine pathologies, and
although the
performance of various pedicle screw constructs have become predictable, there
are still
multiple challenges with the placement and insertion of the pedicle screws or
other bone
anchors. The challenges occur when a surgeon is unable to reference honey
landmarks due
to previous surgery or when the patient's anatomy is irregular in shape.
Surgeons now have the ability to readily convert magnetic resonance imaging
(MRI)
data or computed tomography (CT) data into a data set readable by computer-
aided design
(CAD) program and/or finite element modeling (FEM) program, which then may be
used
to create, for example, a custom implant based on the dynamic nature of the
anatomical
structures the custom implant is designed to associate with. This data, while
currently used
by surgeons in surgery planning, is largely unused for creating a customized
set of
instruments or other surgical devices that are designed to complement the
patient's unique
anatomy.
It would therefore be advantageous to provide apparatus suitable for use with
a
surgical procedure that is adapted and/or configured and/or capable of
conforming to a
plurality of anatomical features of a particular patient and/or to one or more
additional
apparatus to assist the surgeon in completing the surgical procedure(s) safely
and efficiently,
and that otherwise significantly reduces, if not eliminates, the problems and
EDC_LAVIA 2100804\1
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risks noted above. Other advantages over the prior art will become known upon
review of
the Summary and Detailed Description of the Invention and the appended claims,
SUMMARY OF THE INVENTION
According to one aspect of the present disclosure, a novel system and method
is
described for developing customized apparatus for use in one or more surgical
procedures.
The system and method according to this embodiment uses a patient's unique
morphology,
which may be derived from capturing MRI data or CT or other data to derive one
or more
"Patient Matched" apparatus, which comprises complementary surfaces based on a
plurality
of data points from the MRI or CT data. Each "Patient Matched" apparatus is
matched and
oriented around the patient's own anatomy, the desired insertional
trajectories (which may
be verified in a pre-operative setting using 3D CAD software), and according
to one
embodiment described herein, other apparatus used during the surgical
procedure.
According to embodiments, the data obtained from the patient permits the
apparatus to be manufactured with defined pathways through the apparatus,
which are
operatively associated with at least one tool, instrument, or implant, and
which permit the
at least one tool, instrument or implant to be inserted in the defined
pathways in a consistent
and reproducible manner. Examples of devices that are implanted or remain in
the patient
include anchoring devices such as screws, pins, clips, hooks, etc,, and
implantable devices
such as spacers, replacement joints, replacement systems, cages, etc.
According to yet another aspect of the present disclosure, a preconfigured
surgical
template is disclosed, which comprises one or more guides for receiving at
least one tool.
According to this embodiment, the one or more guides further comprise patient-
contacting
surfaces formed to be substantially congruent with the anatomical features of
a patient. The
preconfigured surgical template is configured such that the patient-contacting
surfaces are
configured to contact the plurality of anatomical features in a mating
engagement, to ensure
proper alignment and mounting of the guide or template, and the guides of the
preconfigured
surgical template are oriented in a direction selected prior to manufacturing
of the
preconfigured surgical template to achieve desired positioning, aligning or
advancing of a
tool within the one or more guides.
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In one embodiment, a cutting guide is interconnected to a portion of the
template
or guide. The cutting guide includes a track adapted to guide an instrument
operable to
remove, or alter, a predetermined portion of the vertebrae of the patient. In
one
embodiment, the track of the cutting guide includes patient-specific depth,
angle, and
.. orientation control to guide the instrument.
In one embodiment, the track is formed through a portion of the body. In
another
embodiment, the track is formed by a portion of an exterior surface of the
body. The
portion of the exterior surface may comprise a substantially planar surface
against which a
portion of the instrument may move in a predetermined plane.
In one embodiment, the guide further comprises a frame. The frame is
configured
to be fixed to at least one vertebrae of the patient. In one embodiment, the
frame is fixed
to screws anchored in the at least one vertebrae. The body of the guide is
adapted to
releasably interconnect to the frame. In this manner, the guide may be used
before, or
after, a guide of another embodiment of the present invention used in a
surgical procedure.
In one embodiment, the at least one track comprises two tracks formed in the
body.
In one aspect of the present invention a patient-specific template is
provided. The
template is adapted for use in a surgical procedure and includes, but is not
limited to, a
body having a proximal portion and a distal portion. The distal portion is
shaped to
substantially conform to a predetermined portion of a vertebrae of a patient.
The body
includes at least one of a bore and a track oriented in a direction determined
from
anatomical features of the patient. In one embodiment, the bore or track is
adapted to
guide an instrument or a fixation device.
A portion of the body is adapted to hook at least partially around, and
substantially
.. conform to, at least a second predetermined portion of the vertebrae of the
patient. In one
embodiment, the hook portion of the body comprises an extension of the distal
portion of
the body. In another embodiment, the extension of the body is designed to hook
at least
partially around vertebral anatomy selected from the group consisting of: a
lamina, a pars
interarticularis, an aspect of a transverse process, a spinous process, an
inferior articular
process, and a superior articular process.
In one embodiment, the distal portion of the body of the template is shaped to
substantially conform to cut surfaces generated by removal of a portion of the
patient's
vertebrae. The portion of the patient's vertebrae may have been removed during
a
previous portion of the same surgical procedure. In another embodiment, at
least a portion
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of the distal portion is shaped to substantially conform to an unaltered
portion of the
patient's anatomy.
In one embodiment, the bore is directed in a cortical bone trajectory. In
another
embodiment, the bore is directed in a pedicle screw trajectory.
In one embodiment a first patient-specific surface is determined from and
complementary to the patient's anatomy. In another embodiment, the anatomical
feature
is a vertebrae and the first patient-specific surface is adapted to
anatomically mate with
one or more of a lamina, a pars, an articular process, and a spinous process
of the
vertebrae.
In one embodiment, a first trajectory is oriented along a pedicle screw
trajectory.
Optionally, the first trajectory may be oriented to guide the instrument
percutaneously in
one of: (1) a cortical trajectory; (2) an S1 alar trajectory; (3) an S2 alar
trajectory; (4) and
S2 alar iliac trajectory; and (5) an iliac trajectory.
In one embodiment, the surgical guide is manufactured by a process selected
from
the group consisting of a rapid prototyping machine, a stereolithography (SLA)
machine, a
selective laser sintering (SLS) machine, a selective heat sintering (SHM)
machine, a fused
deposition modeling (FDM) machine, a direct metal laser sintering (DMLS)
machine, a
powder bed printing (PP) machine, a digital light processing (DLP) machine, an
inkjet
photo resin machine, and an electron beam melting (EBM) machine. Optionally,
the
surgical guide may be made of an aluminum alloy, a chromium alloy, a PEEK
material, a
carbon fiber, an ABS plastic, a polyurethane, a resin, a fiber-encased
resinous material, a
rubber, a latex, a synthetic rubber, a polymer, and a natural material,
Optionally, the surgical guide may be used in one or more of a minimally
invasive
surgical procedure and a minimal access procedure. In one embodiment, the
surgical
guide is configured for use in conjunction with a device that employs
automated or semi-
automated manipulation such that placement of the surgical guide with respect
to the
anatomical feature may be performed remotely by an operator through a computer
controller. In another embodiment, the surgical device is identifiable by
optical,
electronic, or radiological recognition means such that the location and
orientation of the
surgical device with respect to the anatomical feature is verifiable.
4
Additional aspects of the present disclosure will become more readily apparent
from the Detailed Description, particularly when taken together with the
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Figs. 1 is a perspective view of an apparatus according to yet another
alternative
embodiment of the present disclosure;
Figs. 2A-2B are perspective views of a cutting guide according to yet another
alternative embodiment of the present disclosure;
Figs. 3A-3B are perspective views of a cutting tool according to yet another
.. alternative embodiment of the present disclosure;
Fig. 3C is another perspective view according to the embodiment shown in
Figure
3A depicted with the cutting guide of Fig. 2A;
Figs. 4A-4B are perspective views of the cutting tool of the embodiment shown
in
Figure 3A depicted with the cutting guide of Fig. 2A;
Fig. 5A is a front elevation view of a guide of another embodiment of the
present
invention positioned against a vertebral body;
Fig. 5B is another front elevation view illustrating a boring instrument of an
embodiment of the present invention inserted in a cannula of the guide of Fig.
5A;
Fig. 5C is a side view of a guide sleeve of an embodiment of the present
invention
.. positioned proximate to the vertebral body illustrated in Fig. 5A;
Fig. 5D is side view of a cutting tool of an embodiment of the present
invention
inserted into a cannula of the guide sleeve of Fig. 5C;
Fig. 5E is a perspective view of the cutting tool and the guide sleeve of Fig.
5D;
Figs. 5F-5G are additional perspective views of the cutting tool and the guide
sleeve of Fig. 5D;
Fig. 6A is a front elevation view of a frame of an embodiment of the present
invention interconnected to a portion of a patient's spine;
Fig. 6B is a front elevation view of a guide of another embodiment of the
present
invention interconnected to the frame of Fig. 6A;
Fig. 6C is a perspective view of the guide and the frame of Fig. 6B;
Fig. 6D is another perspective view of the guide and the frame of Fig. 6B
including
hidden lines showing the structure of slots formed in the guide;
Fig. 7A is a front elevation view of another guide of the present invention;
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Date Recue/Date Received 2021-01-29
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Fig. 7B is a rear elevation view of the guide of Fig. 7A;
Fig. 7C is a bottom perspective view of the guide of Fig. 7A;
Figs. 7D-7E are a front elevation view and a perspective view of the guide of
Fig.
7A positioned against a vertebral body and including hidden lines showing the
structure of
slots formed in the guide;
Fig. 7F is a side elevation view of the guide of Fig. 7A positioned against
the
vertebral body;
Fig. 7G is another side elevation view of the guide of Fig. 7A positioned
against
the vertebral body and illustrating cuts formed in the vertebral body;
Fig. 8A is a front elevation view of still another guide of an embodiment of
the
present invention;
Fig. 8B is another front elevation view of the guide of Fig. 8A positioned
against a
vertebral body;
Fig. 8C is a side perspective view of the guide of Fig. 8A;
Fig. 8D is a side view of the guide of Fig. 8A positioned against the
vertebral
body;
Fig. 8E is a top view of the guide of Fig. 8A positioned against the vertebral
body;
Fig. 9A is a front elevation view of yet another guide of an embodiment of the
present invention;
Fig. 913 is another front elevation view of the guide of Fig. 9A positioned
against a
vertebral body;
Fig. 9C is a side perspective view of the guide of Fig. 9A;
Fig. 9D is another side perspective view of the guide of Fig. 9A positioned
against
the vertebral body;
Fig. 9E is a side view of the guide of Fig. 9A positioned against the
vertebral body;
Fig. 10A is a front elevation view of a frame of an embodiment of the present
invention interconnected to a portion of a patient's spine;
Figs. 10B-10C are an elevation view and a perspective view of another guide of
an
embodiment of the present invention interconnected to the frame of Fig. 10A;
Figs. 11A-11C are perspective views of still another guide of an embodiment of
the present invention with Fig. 11C illustrating the guide of Fig. 11A
positioned against a
vertebral body that has been altered in a surgical procedure;
Figs. 11D-11E are a front elevation view and a perspective view of the guide
of
Fig. 11A positioned against a portion of the patient's spine that has been
altered in a
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=
surgical procedure and further illustrating the guide in relation to a neural
element of the
patient;
Figs. 12A-12E are perspective views of a guide of yet another embodiment of
the
present invention with Figs. 12C-12D illustrating the guide positioned against
a vertebral
body that has been cut to remove portions of the vertebrae and Fig. 12E
showing the guide
positioned against the vertebral body and neural elements of the patient;
Fig. 13A is a perspective view of yet another guide of the present invention;
Figs. 13B-13C are a side view and a perspective view of the guide of Fig. 13A
positioned in contact with a vertebral body that includes cuts formed using
the guide;
to Fig. 13D is a
front elevation view of the guide of Fig. 13A illustrated in a position
of use against a portion of a patient's spine and illustrating a neural
element of the patient
positioned proximate to a recess of the guide;
Fig. 13E is a side perspective view of the guide of Fig. 13D in a similar
position of
use;
Fig. 14A is a perspective view of a model of an embodiment of the present
invention;
Fig. 14B is a side elevation view of the model of Fig. 14A;
Fig. 14C is rear elevation view of the model of Fig. 14A;
Figs. 14D-14E are a perspective view and a side elevation view of the model of
Fig. 14A positioned in contact with a vertebral body;
Fig. 15A is a front elevation view of another model of an embodiment of the
present invention;
Fig. 15B is a rear elevation view of the model of Fig. 15A;
Fig. 15C is a rear perspective view of the model of Fig. 15A;
Fig. 15D is another front elevation view of the model of Fig. 15A in a
position of
use against a vertebral body;
Fig. 15E is a front perspective view of the model of Fig. 1513;
Fig. 15F is a top perspective view of the model of Fig. 15D;
Fig. 16A is a front perspective view of another embodiment of a model of the
present invention;
Fig. 16B-16C are a front elevation view and a perspective view of the model of
the
embodiment of Fig. 16A positioned proximate to a vertebral body;
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= =
Fig. 17A is a perspective view of yet another guide of an embodiment of the
present invention adapted to interconnect to a model of an embodiment of the
present
invention and showing the guide and the model in a disassembled state;
Fig. 17B is a perspective view of the model and the guide of Fig. I7A in an
assembled state;
Fig. 17C is a front elevation view of the model and the guide of Fig. 17B;
Figs. 17D-17E are a perspective view and a front elevation view of the model
and
the guide of Fig. 17B positioned proximate to a vertebral body;
Figs. 18A-18B are a perspective view and a side elevation view of still
another
embodiment of a model of the present invention;
Figs. 18C-18D are a perspective view and a side elevation view of the model of
Fig. 18A interconnected to a frame of the present invention similar to the
frame of Fig.
10A, illustrating the model in a position of use proximate to a portion of the
patient's
spine;
Fig. 19A is a perspective view of another embodiment of a model of the present
invention;
Fig. 19B is a side perspective view of the model of Fig. 19A;
Figs. 19C-19D are views of the model of Fig. 19A in a position of use
interconnected to a frame of the present invention, the frame fixed to a
portion of a
patient's spine;
Fig. 20A is a perspective view of a three-dimensional model of a unique
grouping
of a portion of patient's spine of an embodiment of the present invention and
illustrating a
portion of the spine being removed;
Fig. 20B is a side elevation view of the three-dimensional model of Fig. 20A;
Fig. 20C is a perspective view of the removed spine portion after some of the
removed spine portion has been cut away;
Fig. 20D is a side elevation view of the three-dimensional model of Fig. 20D
after
the model has been moved to close a gap formed after a portion of the spine
was removed;
Fig. 20E is a side elevation view of the three-dimensional model of Fig. 20B
and
further illustrating an alignment indicator of the present invention
interconnected to the
three-dimensional model and with the model showing the alignment of the
patient's spine
before the planned surgical procedure;
Fig. 20F is another side elevation view of the alignment indicator of Fig. 20E
showing the alignment of the patient's spine after the planned surgical
procedure;
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Fig. 21A is a perspective view of a coronal alignment verification tool of an
embodiment of the present invention positioned proximate to a portion of a
patient's
anatomy;
Figs. 21B, 21C, and 21D are front, bottom, top elevation views, respectively,
of the
tool of Fig. 21A;
Fig. 22A is a perspective view of another embodiment of a coronal alignment
verification tool of the present invention positioned proximate to a portion
of a patient's
spine;
Figs. 22B, 22C, and 22D are a front, top, and right side elevation views of
the tool
to of Fig. 22A;
Fig. 23A is a front elevation view of another tool of an embodiment of the
present
invention for verification of coronal alignment;
Fig. 23B is a right side elevation view of the tool of Fig. 23A;
Fig. 23C is a perspective view of the tool of Fig. 23A;
Fig. 23D is a front view of the tool of Fig. 23A proximate to a portion of the
patient's spine and aligned in relation to the sagittal plane;
Fig. 23E is a side view of the tool of Fig. 23D proximate to the patient's
spine and
aligned in relation to the coronal plane;
Fig. 24A-24B illustrate two side view of an alignment assembly in a position
of
use interconnected to a portion of a patient's spine before and after the
alignment of the
spine is altered during a planned surgical procedure;
Figs. 25A-C are various views of yet another patient-specific guide of an
embodiment of the present invention for contacting surfaces and trajectories
in a patient's
spine;
Figs. 26A-26C are various views of the guide of Figs. 25A-C shown in relation
to a
vertebral body of a patient;
Figs. 27A-27C are various views of another patient-specific guide of another
embodiment of the present invention for contacting surfaces and trajectories
in a patient's
spine;
Figs. 28A-28B are various views of still another embodiment of a patient-
specific
guide of an embodiment of the present invention;
Figs. 29A-29C are various views of another patient-specific guide of an
embodiment of the present invention;
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= 6
Figs. 30A-30C are various views of a patient-specific guide for contacting
surfaces
and trajectories in a patient's spine according to yet another embodiment of
the present
invention;
Figs. 31A-31C are various views of a guide of an embodiment of the present
invention further comprising secondary and tertiary sleeves of still another
embodiment of
the present invention;
Fig. 32A-32B are various view of still another embodiment of a patient-
specific
guide of an embodiment of the present invention;
Figs. 33A-33B are perspective views of another embodiment of a patient-
specific
guide of the present invention;
Figs. 34A-348 are a bottom plan and a perspective view of another patient-
specific
guide of the present invention;
Figs. 35A-35C are perspective views of still another patient-specific guide of
the
present invention;
Figs. 35E-35F are additional perspective views of the patient-specific guide
of
Figs. 35A-35D positioned against a vertebral body;
Fig. 36A is a perspective view of yet another patient-specific guide of an
embodiment of the present invention in which cannulae of the guide do not
contact
vertebrae of a patient's spinal column;
Figs. 36B-36C are perspective views of the patient-specific guide of Fig. 36A
positioned against a vertebral body and illustrating distal ends of the
cannulae separated
from the vertebral body by a predetermined distance;
Figs. 36D-36F are perspective views of another patient-specific guide similar
to
the guide of Fig. 36A, the guide adapted to be positioned within an incision
against a
patient's boney anatomy and including external cannula adapted to remain
outside of a
skin envelope and further including internal cannula arranged to be within the
skin
envelope, the external and internal cannula being collinearly aligned;
Figs. 37A-37B are a side perspective view and a top perspective view of
another
embodiment of a patient-specific guide of the present invention;
Figs. 37C-37D are perspective views of the patient-specific guide of Fig. 37A
positioned against a vertebral body;
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Fig. 38 is an exploded perspective view of an interbody guide for facilitating
a
surgical procedure according to one embodiment of the present disclosure;
Fig. 39 is a right side elevation view of another embodiment of an interbody
guide;
Fig. 40 is a perspective view of the interbody guide shown in Fig. 38 with a
different guide sleeve inserted in the aperture of the interbody guide;
Fig. 41 is another perspective view of the interbody guide shown in Fig. 38
with
still another guide sleeve inserted in the aperture;
Fig. 42 is a perspective view of the interbody guide shown in Fig. 38 between
two
vertebral bodies;
Figs. 43A-43B are bottom rear perspective views of the interbody guide shown
in
Fig. 42 proximate to the superior vertebral body;
Figs. 44A-44B are perspective views of the interbody guide shown in Fig. 42
with
the guide sleeve of Fig. 40 inserted in the aperture; and
Figs. 45A-45B are perspective views of another interbody guide between two
different vertebral bodies.
DETAILED DESCRIPTION
As shown in the appended Figures and described in further detail herein, the
present disclosure relates to a novel system and method for developing a
variety of
customized, patient-matched apparatus for use in a diverse number of surgical
procedures.
The system and method uses a patient's unique morphology, which may be derived
from
capturing MRI data, CT data, or any other medical imaging device to derive one
or more
patient-matched apparatus, which comprise complementary surfaces to those
encountered
during the surgical procedure(s) as derived from a set of data points.
According to various
embodiments described herein, the patient-matched apparatus may further
comprise
desired axes and/or insertional trajectories.
Multiple embodiments of the disclosure are depicted in Figs. 1-45. Figure 1 is
a
perspective view of an apparatus for facilitating a surgical procedure
according to an
embodiment of the present disclosure. In this embodiment, the apparatus formed
by the
system and method described above comprises a cutting guide 10. The guide 10
can be
used to orient a cutting tool to alter and, optionally, remove portions of the
anatomy of the
patient. A variety of cutting tools, including (but not limited) routers,
burrs, and osteotome
may be used with the guide. The guide 10 illustrated in Fig. 1 is a
laminectomy guide
adapted to facilitate the use of surgical cutting instruments to alter the
patient's lamina.
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However, guides of the present invention may be adapted for use in procedures
to alter
any portion of the patient's anatomy. In one embodiment, the guides of the
present
invention may be used in procedures to alter posterior portions of the
patient's anatomy,
including without limitation facet joints, transverse processes, articular
processes, and
spinous processes of a patient.
In the embodiment of the present invention illustrated in Fig. 1, the guide 10
is
adapted to fit directly to aspects of a patient's anatomy. More specifically,
the guide is
positioned proximate to a medial vertebrae VM between a superior and inferior
vertebrae
VS, VI. Thus, the laminectomy cutting guide 10 also comprises a lower patient-
contacting
surface 14 which permits the laminectomy cutting guide 10 to mate with one or
more
vertebral bodies. The patient specific surface 14 can be specific to any
portion of the
patient's anatomy, such as lamina, transverse processes, articular processes,
spinous
processes, etc. Alternatively, the guide 10 can be interconnected to a frame
as described in
more detail herein. Surface 14 may be adapted to at least partially hook
around a portion
of the patient's anatomy. For example, the surface 14 may comprise multiple
portions
14A, 14B that are adapted to contact two different planes formed by two
distinct portions
of the patient's anatomy.
The laminectomy cutting guide 10 illustrated in Fig. 1 further comprises at
least
one alignment channel 16 for inserting a guide wire or other securing element,
and a
cutting slot 20 for directing the path of a blade or other cutting edge. The
alignment
channel 16 may receive a fixture, such as a temporary fixation device, to
temporarily fix
the guide 10 to the patient's spine. The temporary fixation device may be a
pin or screw
such as those known to one of skill in the art. Placing a fixture through the
channel 16 can
increase stability of the guide during use of the guide in a cutting
procedure. Optionally,
the channel 16 may comprise a cannula adapted to receive a tool, such as a
tool for
forming a bore in the patient's anatomy. Thus, in one embodiment, the
alignment channel
16 may optionally comprise a bore adapted to guide an instrument or a fixation
device,
such as a pedicle screw..
The slot 20 can have any shape determined to guide cuts for a planned surgical
procedure for a particular patient. For example, the slot may have a shape to
guide
instruments to provide straight, concave, convex, or 'chevron' shaped cuts. In
one
embodiment, the slot includes multiple portions 20A, 20B, 20C.
The cutting slot 20 may be sized or shaped to prevent the use of an
inappropriate
tool. Additionally, the slot may be shaped to guide a cut around a neural
element of the
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patient. Accordingly, the slot 20 can be used to guide instruments along a
presurgically
planned pathway while controlling instrument orientation and depth. Further,
the width of
the slot 20 may change to control the size of a cutting tool that fits through
the slot. For
example, slot portion 20A may have a different dimension than portions 20B,
20C. In one
embodiment of the present invention, slot portion 20A has a different width
than slot
portions 20B, 20C.
Stops may be formed in the slot 20 to limit or control the depth of insertion
of the
cutting tool. The stops may be specific to the patient's anatomy and allow for
protection of
neural elements of the patient. The slot 20 may also be keyed to ensure depth
control while
cutting. For example, the slot 20 may include a key that alters the depth of
cutting by the
tool as the tool is guided through the slot. The key may correspond to a
feature, such as a
protrusion 144 on the tool 140, described in more detail in conjunction with
Fig. 3, that
limits the depth of insertion of the tool.
Optionally, a sleeve 24 or an insert may be selectively retained in the slot
20. The
insert 24 includes a slot 26 for a cutting tool. The sleeve 24 separates and
protects the
guide 10 from the cutting tool. For example, if the guide 10 is formed of a
material that
may be cut by the cutting tool, the size and shape of the slot 20 could be
changed by the
cutting tool. The insert 24 is provided to prevent the cutting tool from
altering the slot 20.
In this manner, the insert may prevent deviation from a planned surgical
procedure.
It will be appieciated that the insert 24 may have any site and shape selected
to be
at least partially received in the slot 20. Further, the insert may project at
least partially
from the proximal side of the guide 10. In one embodiment, the insert 24 has a
cross-
sectional profile substantially the same as the cross-sectional profile of the
slot 20. The
insert 24 may have a length that is the same as, or similar to, the depth of
the slot.
In one embodiment, the slot 20 may be sized to receive more than one sleeve
24.
Each sleeve may be adapted to guide a different tool or define a different
cut. For
example, a first sleeve may be introduced into the slot to guide a first tool
to create a first
cut. The first sleeve may then be replaced by a second sleeve introduced into
the slot.
The second sleeve may guide a second tool to create a second cut. The second
sleeve may
have a different size and shape than the first tool. In one embodiment, the
second cut
alters the first cut. Alternatively, in another embodiment, the second cut
does not intersect
the first cut.
The insert 24 may be formed of any material that is of sufficient strength
that
breaking and/or flaking of the insert material is avoided. Accordingly, the
insert 24 may
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CA 03001898 2018-04-12
withstand the effects of high-speed cutting tool without damaging the insert
or permitting
material from the insert to become deposited in the cutting site as well as re-
use of the
insert. The insert material must also withstand the high temperatures
encountered during
sterilization. In one embodiment the insert is formed of a metal or metal
alloy, although
other materials are contemplated. One benefit of a metallic insert is the
ability to
"trephine" or machine a cutting surface to permit the distal end of the insert
to "bite" into
the bone and provide means for fixation of the insert. Forming a trephine on
the distal end
may provide further stabilization of the guide during a cutting operation. In
another
embodiment, the insert is formed of any material that is harder than the
material of the
to guide.
The insert 24 may be adapted to receive different types and sizes of tools.
Additionally, or alternatively, the insert may be operable to receive only one
particular
tool. Inserts can also be provided to ensure cuts are performed in a
preplanned sequence.
For example, when the slot of a guide 10 has a compound shape, such as slot 20
with three
different portions 20A, 20B, 20C, the surgical plan may include a first
operation through
slot portion 20A followed by operations through portion 20B and then 20C.
Accordingly,
a first insert 24A may be provided to receive a tool in portion 20A through
slot 26A while
blocking access to slot portions 20B, 20C. After the first operation is
completed, the first
insert may be replaced with second and third inserts 24B, 24C to allow access
to slot
portions 20B, 20C. One of the inserts, for example, insert 24B, may have a
different length
that the other inserts.
Additionally, or alternatively, the insert 24 may include stops to limit an
angle of
use of the cutting tool during the surgical procedure. Indieia may be
positioned on the
guide and the inserts to indicate a sequence of use conforming to the sequence
of
operations in which the guide is to be used. The indicia may also indicate a
tool to be used,
a direction of a cut to be performed, or a particular portion of the patient's
anatomy
targeted by a cut. The indicia may comprise computer readable elements, such
as a bar
code or an RFID. Thus, the indicia may be used to identify the guide and to
retrieve
information about a procedure to be performed with the guide 10.
In one embodiment, the cutting guide 10 designed following acquisition of a
scan
of the patient's anatomy with a medical imaging device. The scan may be
performed by a
CT scanner, an MRI scanner, or any other medical imaging device. The scan is
segmented
into 3D models of each vertebra. These 3D models are then modified in CAD to
simulate
the correction desired by the surgeon. Once the desired correction is
appropriately
14
CA 03001898 2018-04-12
simulated, a guide 10 is generated that will allow the surgeon to make the
planned
corrections intraoperatively.
Although shown in Fig. 1 as a generally rectangular prism, it is expressly
understood that other geometrical shapes for the laminectomy cutting guide 10
are equally
as practical, and considered within the scope of the disclosure. The cutting
guides of the
present invention can be used as physical cutting guides. Additionally, the
cutting guides
may be used as an aid to indicate to surgeons the angle and location of
osteotomy cuts so
that neural elements in the patient's spine are not harmed. The guides may
also be used
pre-surgically on models of the patient's anatomy to test or practice the
planned surgical
.. procedure.
Referring now to Figs. 2A-2B, further illustrations of a cutting guide 110 are
provided. According to one embodiment, the cutting guide 110 comprises a
plurality of
patient-specific contacting surfaces 114 about at least one surface of the
cutting guide and
an alignment channel 116. The contacting surfaces may comprise portions 114A,
114B
adapted to hook at least partially around portions of the patient's anatomy.
In one
embodiment, the contacting surfaces 114 are adapted to conform to cut surface
generated
by removal of a portion of the patient's anatomy. The cutting guide further
comprises, in
a preferred embodiment, a patient-specific slot or "track" 120 for
facilitating insertion of a
cutting instrument (as shown in Figures 3-4) and controlling the depth of
insertion for that
instrument to prevent unnecessary cutting of the underlying surface during a
particular
surgical procedure by further providing one or more instrument contacting
surfaces 122.
According to the embodiment shown in connection with Figs. 2-4, the cutting
guide 110 may be provided for a laminectomy. According to other embodiments,
the
patient-specific guide may be fabricated for use in performing a corpectomy, a
Pedicle
Subtraction Osteotomy (PSO), a Smith-Peterson Osteotomy (SPO), a Vertebral
Column
Resection (VCR), or an Asymmetric Osteotomy (in either the sagittal or coronal
plane),
among others.
These patient-specific cutting guides 10, 110 may be fabricated from patient
anatomical data, and may assist in performing complex procedures with greater
certainty
in their outcomes. For example, certain osteotomies, specifically PSO and SPO,
require a
great deal of surgical skill and are often time consuming. By using a patient-
specific
guide, a surgeon may confirm positioning and alignment of the cutting
trajectory and path
prior to initiating the procedure, and in furtherance of the disclosure
provided above in
CA 03001898 2018-04-12
3
relation to Figs. 2-4, may also provide a degree of depth control essential
for avoiding
contact with vascular and neural elements.
In one embodiment, the cutting tool 140 associated with the cutting guide 110
shown in Figs. 2-4 is typical of the type of tools currently used in surgical
procedures.
According to another embodiment, a specialty cutting bur or tip 142 may be
included with
the instrument to facilitate further control of the location and depth of the
instrument, as
described in further detail below. For example, as shown in Figs. 3A-3C, the
cutting
portion of the instrument may have a protrusion 144 that prevents greater
insertion of the
instrument 140 into the cutting guide 110 than required for the patient-
specific procedure.
In one embodiment, the position of the protrusion 144 on the cutting tip 142
may be
adjusted by a user. The protrusion 144 may be of any form adapted to interact
with
contact surfaces 122 of the slot 120 to control the use of the cutting tool
140. In one
embodiment, the protrusion 144 is a bearing. In another embodiment, the
protrusion is a
track ball. In still another embodiment, the protrusion is generally disc-
shaped.
As shown in greater detail in Figs. 4A-4B, the protrusion 144 may be inserted
into
a first portion 120C of the "track" 120 of the cutting guide 110. Second or
third deeper
portions 120A, 120B of the "track" of a cutting guide (through which the
cutting surface is
permitted to travel), may prevent insertion or withdrawal of the protrusion
144, thereby
insuring proper depth of the cutting instrument. Further geometrical
configurations other
than those shown in Figs. 4A-4B may be provided that allow the protrusion 144
to move
horizontally with respect to the top surface of the cutting guide, and in some
instances
laterally and downwardly into the track 120 of the cutting guide. In this
embodiment, the
cutting instrument 140 would therefore be permitted to move at a certain depth
about a
patient's anatomy in a certain location of the "track" 120 of the cutting
guide, but achieve a
greater depth at yet other locations about the "track" 120 of the cutting
guide 110. Thus,
the depth permitted with respect to the instrument 140 relative to the cutting
guide 110
may be variable about the "track" 120 of the cutting guide.
It will be appreciated by one of skill in the art that the size and location
of the
surfaces 122 may be altered as desired. Accordingly, in other embodiments of
the present
invention, the instrument 140 may be inserted and removed from different
portions of the
track 120, or from two or more portions of the track. Further, in one
embodiment, the
track 120 and the instrument 140 include protrusions that interact to permit
the tool to be
inserted in only a first portion of the track, for example portion 120C, and
removed from
only a second portion of the track, such as portions 120A or 120B.
16
CA 03001898 2018-04-12
Referring now to Figs. 5A-5F, a guide sleeve 210 of another embodiment of the
present invention is described. The sleeve 210 is adapted for use in a
posterior osteotomy,
also known as a Smith-Petersen Osteotomy (SPO) or a "ponte osteotomy"
procedure. As
will be appreciated by one of skill in the art, during a posterior osteotomy,
a portion of
bone is removed from the back of the patient's spine. Portions of the
posterior ligament
and facet joints may also be removed from targeted portions of the patient's
spine. The
osteotomy may be performed at one or multiple locations along the spine to
correct the
alignment of the patient's spine.
In one embodiment of the present invention, a surgical guide 246, guide sleeve
248
to and drilling
insert or sleeve 249 assembly according to an embodiment of the present
disclosure is positioned proximate to a targeted portion of the patient's
anatomy. The drill
sleeve 249 (placed through the patient-matched guide sleeves 248 and into the
bone at
opposing, dissimilar angles) provides additional fixation of the guide 246 to
the vertebra
V.
The guide 246 is used to introduce a bore (not illustrated) into the pedicle
for the
guide sleeve 210. The trajectory of the bore is specifically planned and
controlled by
sleeve 248 for the drilling sleeve 249. The placement of bore is selected in
such a way that
neural elements are protected from the tool 247 inserted through the drilling
sleeve 249.
The trajectory of the bore is selected to be a predetermined distance away
from the neural
elements so that the tool 247 is a safe distance away. In one embodiment, the
bore is at
least 0.25 mm away from the patient's neural elements. However, it will be
appreciated
that any predetermined distance separating the bore from neural elements may
be used. In
another embodiment, the distance is from about 0.1 mm to about 3 mm.
Referring now to Figs. 5C-5G, once the pedicle is cannulated, the surgical
guide
246 may be removed from the vertebrae V. A guide sleeve 210 is inserted to a
controlled
depth within the bore. The cutting tool 240 is inserted into a cannula 225 of
the sleeve 210
and activated. The tool includes a surface 242 that cuts from the interior to
the exterior of
the pedicle. In one embodiment of the present invention, the guide sleeve 210
includes an
aperture 218 for the cutting surface 242. The aperture 218 may be spaced from
the distal
end of the guide sleeve 210 by a predetermined amount to control the depth of
the cut. In
another embodiment, the aperture is positioned at the distal end of the sleeve
210.
The cutting surface 242 may be mechanically or electrically actuated. The
cutting
surface 242 may comprise a reciprocating or a rotating blade, or any other
type of cutting
tool. In one embodiment, the orientation or length of the cutting surface 242
may be
17
altered by the surgeon during the surgical procedure. Optionally, in another
embodiment
of the present invention, the tool is operable to ablate portions of the
pedicle to complete
the cut. For example, the tool may comprise a laser adapted to burn through
portions of the
pedicle from within the bore. In another embodiment, the tool may comprise a
heated
surface to burn or otherwise remove portion of bone or tissue. Once the cut
has been
made, the posterior column of the vertebra can be removed.
Referring now to Figs. 6A-6D, an embodiment of a guide 310 comprising a frame
330 is illustrated. The guide 310 is adapted for use in a posterior osteotomy,
although
other procedures are contemplated. The frame 330 may have a patient-specific
shape. For
example, the frame may be adapted to flex or snap into a position in contact
with a transverse
process T or other portion of the patient's anatomy. Alternatively, the frame
330 may be
designed to be used in surgical procedures for any patient.
In use, the frame 330 is interconnected to fixation devices 334 positioned in
predetermined portions of the patient's anatomy, such as the patient's
vertebrae, V. In one
embodiment, as illustrated, the vertebrae V include an inferior vertebra VI, a
medial
vertebra VM, and a superior vertebra VS. The fixation devices 334 may be
pedicle
screws.
Although two fixation devices 334 in each of the inferior and superior
vertebra VI,
VS are illustrated in use with the frame 330 of the embodiment of Fig. 6, it
will be
appreciated that any number, including fewer screws, may be used with the
frame. The
size and shape of the frame 330 may be selected to only permit the frame to be
interconnected to the screws when the frame is in a pre-planned orientation.
For example,
the embodiment of the frame 330 illustrated in Fig. 6A has a shape that only
permits the
frame to be interconnected to the four pedicle screws 334 when the frame is in
one
predetermined orientation.
The pedicle screws 334 or other fixation devices may be placed in the
vertebrae
using any tool or guide. Pre-existing pedicle screws from a previous surgery
may be used
with the frame. One or more of the pedicle screws may also be positioned using
a pedicle
screw guide of an embodiment of the present invention, for example, the guide
246
described above. Other embodiments of pedicle screw guides are described in
the
Applicant's U.S. Patent 9,198,678.
The frame 330 may retract soft tissue in the surgical area. Further, reference
points
or indicia may be provided on the frame 330 for docking the osteotomy guide
310. The
indicia may indicate a planned orientation or alignment of the guide. The
shape of the
18
Date Recue/Date Received 2021-01-29
CA 03001898 2018-04-12
frame 330 may only permit docking of the guide when the guide 310 is in a pre-
planned
orientation with respect to the targeted vertebrae.
The frame 330 may also be used to distract the vertebrae in a target area of
the
patient's spine by a predetermined amount. The distraction provided by the
frame may
ensure a cut is formed at a predetermined angle. The distraction may also be
necessary to
provide access to a predetermined portion of the patient's anatomy. Once
interconnected
to the pedicle screws 334, the frame 330 may also prevent unintended movement
of the
vertebrae during the surgical procedure. The frame may also be planned such
that it
increases the distraction of the construct to provide the surgeon with a
larger window
to through which the surgery can be completed. In this embodiment the frame
connects the
superior vertebra VS (above the osteotomy location of the medial vertebra VM)
to the
inferior vertebra VI (below the osteotomy location). In one embodiment, the
frame is
positioned lateral to the pedicles so that the posterior anatomy of the medial
vertebra VM
is substantially unobstructed by the frame 330. It will be appreciated by one
of skill in the
art that the frame may be sized to span any number of vertebra.
Once the frame 330 is interconnected to the pedicle screws, the guide 310 is
interconnected to the frame. The guide 310 is presurgically planned to align
on the frame
330 with targeted portions of the medial vertebrae VM in a patient-specific
location so that
cuts are made accurately.
Although the embodiment of the guide 310 illustrated in Figs. 6B-6D is shown
as
one piece, it will be appreciated that in other embodiments the guide could
include
multiple pieces or a series of cutting guides that are placed in a specific
order to generate a
series of planned cuts. In embodiments of guides comprising multiple pieces,
each piece
of the guide may be keyed to interconnect in a specific order and location to
other pieces
of the guide. In one embodiment, the guide 310 does not contact the patient's
anatomy.
Said another way, the guide 310 is adapted to float over a surgical area when
the guide is
interconnected to the frame 330. In another embodiment, at least a portion of
the guide
310 is adapted to contact the patient's anatomy.
The guide may include slots 320 and apertures 328. The aperture 328 may be
.. positioned to prevent contact with portions of the patient's anatomy. For
example, the
guide 310 of the embodiment illustrated in Figs. 6B-6D includes and aperture
328 to at
least partially receive the spinous process S of the medial vertebra VM. The
aperture 328
and surfaces of the guide proximate to the patient's anatomy may include
patient specific
contours adapted to substantially conform to predetermined portions of the
patient's
19
CA 03001898 2018-04-12
anatomy. In this manner, the alignment of the guide with a planned portion of
the
patient's anatomy may be enhanced. The patient specific contact contours may
also
improve the stability of the guide 310 during the procedure.
The slots 320 are positioned and have sizes to guide tools used during the
surgical
procedure, similar to the slots 20, 120 of the guides 10, 110 described above.
The slots 320
may have shapes and be positioned at a variety of angles to guide tools,
including cutting
tools. Each slot 320 may have a unique size and orientation. Thus, slots may
be adapted
to receive different tools, or only one specific tool. Features, such as
protrusions, may be
formed in the slot and interact with features of the tools to control the
depth of insertion of
.. the tool, direction of use of the tool, and insertion and removal points of
the tool. Inserts,
similar to the insert 24 described above, may be formed to be positioned in
the slots 320 to
prevent damage to the slots or to ensure proper use of tools during the
procedure.
Referring now to Figs. 7A-7G, still another embodiment of a guide 410 of the
present invention is illustrated. The guide 410 is adapted for use in pedicle
subtraction
osteotomies (PSO) and asymmetrical pedicle subtraction osteotomies (APSO) for
a single
vertebral level. The size and shape of the guide may be selected to fit the
guide across the
surface of the vertebra V.
The guide 410 may comprise one piece adapted to target one portion of the
vertebra. Alternatively, the guide may be formed in two or more pieces to
target a variety
of locations of the vertebra. The pieces can guide an ordered sequence of cuts
in the
vertebra. In one embodiment, the pieces may be interconnected in sequence
during the
surgical procedure to form the guide 410.
In one embodiment, the guide 410 may fit directly to the posterior aspects of
a
patient's anatomy, such as lamina, transverse processes, articular processes,
spinous
processes, etc. Accordingly, a variety of patient matching surfaces 414 may be
provided
on the guide 410. Additionally, or alternatively, the guide 410 could also fit
to a surface
of the spine that has previously been cut. In one embodiment, the previous cut
may be
performed using an initial guide of the present invention. The initial guide
is adapted to
guide a cutting tool used to generate a surface of the vertebrae. The guide
410 may be
designed to fit to the surface generated using the initial guide. Additional
cuts in the
altered vertebrae can then be performed using the guide 410. Alternatively,
the guide 410
may be interconnected to any frame described herein, including frames 330,
730.
The guide 410 includes slots 420 to guide surgical tools, including cutting
tools
such as routers, burrs, and other similar device, along a track to aid in
removal of pedicles.
CA 03001898 2018-04-12
=
The slots 420 may be the same as, or similar to, the slots of guides 10, 110
described
above. The slots have a size and orientation selected to constrain cutting
tools to pre-
surgically planned entry points and angles of cuts for the procedure. As will
be
appreciated, the slots 420 may be oriented in a plane transverse to the
proximal surface
portion of the guide 410. The slots can be planned to guide tools to make cuts
that are
substantially linear, concave, convex, curvilinear, or "chevron" shaped.
Further, as
described above, the slots 410 may receive sleeves 24 and can include stops
and keys to
guide or restrict movement of the surgical tool.
Optionally, the guide 410 includes an alignment channel or cannula 416. The
cannula 416 is adapted to guide a fixture tool or anchor, such as fixture 434,
into the
vertebra. It will be appreciated that the cannula 416 may be positioned in a
variety of
locations on the guide. Further, more than one cannula can be provided.
In one embodiment, as illustrated in Figs. 7E-7G, the guide 410 is anchored to
the
vertebrae by an anchor 434. After the cuts 450 (illustrated in Fig. 7G) have
been
completed in the pedicle of the vertebrae V. the entire cut portion of the
pedicle can be
removed along with the guide 410 by pulling the anchor 434 away from the
vertebrae V.
Figs. 8A-8E illustrate another embodiment of a guide 510 of the present
invention.
In one embodiment, the guide 510 is adapted for use in PSO and APSO
procedures. The
guide is sized to partially span adjacent superior VS and inferior VI
vertebrae. Similar to
the guide 410, guide 510 includes patient specific contact surfaces 514
adapted to
substantially conform to the patient's anatomy. For example, in one
embodiment, the
distal surface 515 of the guide includes a plurality of patient specific
contours. At least
one portion of the distal surface 515 may be adapted to contact a cut surface
formed by
removal of a portion of the patient's anatomy.
A number of apertures may be formed through the guide to target, avoid, or
align
with, predetermined portions of the patient's anatomy. For example, an
aperture 528 may
be formed through the guide 510 with a shape selected to allow the spinous
process S to at
least partially pass through the guide. Patient specific surfaces 514 may be
formed within
the aperture 528.
The guide may further include a pedicle aperture 529 with a pre-planned shape
to
at least partially receive the pedicle P of the patient. The pedicle aperture
529 may also
include interior surfaces that are patient specific. A surgeon may insert
cutting tools into
the aperture 529 to remove portions of the pedicle P. The pedicle aperture may
be shaped
to prevent over insertion of a tool into the vertebrae. Further, keys may be
formed around
21
CA 03001898 2018-04-12
the aperture 529. In conjunction with a protrusion formed on the tool, such as
the
protrusion 144 described above, the keys may control or alter the depth of
insertion of the
tool as the surgeon move the tool around the aperture 529.
The guide 510 may also include a cutting track 520. The track 520 is similar
to
slots 20, 120, 320 described above and may receive a guide sleeve the same as,
or similar
to, sleeve 24. In one embodiment of the present invention, the cutting track
520 is adapted
to target facet capsules of each of the superior VS and inferior VI vertebrae.
The surgeon
may use the cutting track 520 to separate the adjacent facet capsules of the
adjacent
vertebrae. As will be appreciated, other cutting tracks or cutting slots may
be provided on
the guide to control other planned cuts.
Although not illustrated, the guide 510 may include a cannula similar to
cannula
16, 416 describe above. A fixture implanted in the vertebrae may be received
in the
cannula to at least temporarily interconnect the guide 510 to the vertebrae.
Optionally, the
cannula may be adapted to guide an instrument, including a boring instrument
or cutting
tool 240.
Referring now to Figs. 9A-9E, still another embodiment of a guide 610 of the
present invention is illustrated. The guide 610 is similar to guide 510 and
includes a distal
surface 615 that may include patient specific contact surfaces. At least one
of the contact
surfaces may be adapted to substantially conform to an unaltered portion of
the patient's
anatomy. Another portion of the distal surface 615 may be adapted to
substantially
conform to a portion of the patient's anatomy altered, for example, by a cut.
An aperture
628 adapted to at least partially receive the spinous process S may be
provided. The
aperture 628 may include patient specific surface 614.
The guide 610 is adapted to target each pedicle P of a vertebrae V.
Accordingly,
the guide includes two pedicle apertures 629. The apertures are the same as,
or similar to,
the pedicle aperture 529 of the guide 510 describes above. In one embodiment,
each
pedicle aperture 629A, 629B may have a unique shape specific to the patient's
anatomy.
Optionally, the guide 610 may have a thickness determined such that the
pedicles P do not
project beyond a plane formed by a proximal surface as illustrated in Figs.
9D, 9E.
Voids 617 may also be formed in portions of the guide to align the guide with
the
vertebrae V. The voids may be in various positions. Further, the voids 617 may
extend
partially or completely through the guide 610. In addition, a protrusion 619
may extend
from the distal surface 615 of the guide. The protrusion may be adapted to fit
to a selected
portion of the posterior of the vertebrae. Optionally, the void 617 or the
protrusion 619
22
CA 03001898 2018-04-12
may at least partially hook around a portion of the patient's anatomy. In this
manner, the
void 617 and protrusion 619 contact distinct portions of the patient's anatomy
compared to
other portions of the distal surface 615. The void and protrusion thus provide
references
to indicate when the guide 610 is positioned in a predetermined position in
relation to the
patient's anatomy. Said another way, the void 617 or protrusion 619 will
prevent the
guide 610 from seating properly when the guide is in an improper position.
Thus, the
guide will not be stable, providing tactile feedback to the user that the
guide is not in the
correct position. In one embodiment, the protrusion 619 is adapted to fit the
guide to a
portion of a transverse process or a lamina. Each void 617 or protrusion 619
may further
include patient specific surfaces.
Referring now to Figs. 10A-10C, a guide 710 of another embodiment of the
present invention is illustrated. In one embodiment, the guide 710 is adapted
for use in a
PSO or an APSO procedure. Portions of the posterior of the superior vertebrae
VS, medial
vertebrae VM, and the inferior vertebrae VI (such as the transverse process,
spinous
process, lamina, and/or pedicles) are removed by cuts 750 prior to the use of
the guide
710.
A frame 730 is interconnected a portion of the patient's spine. The frame
generally
comprises a medial member 732 connecting two transverse members 733. In one
embodiment, the frame 730 is interconnected to the superior vertebrae VS and
the inferior
vertebrae VI. Pedicle screws 734 positioned in the superior and inferior
vertebrae may be
used to secure the frame to the vertebrae. The frame 730 may be similar to,
and include the
features of; the frame 330 described above. Thus, the frame 730 may preserve
an existing
amount of distraction. In one embodiment, the frame is used to preserve the
relationship
between the medial vertebrae VM and the adjacent superior and inferior
vertebrae VS, VI.
Alternatively, the frame is adjustable in order to change the distraction of
the construct as
necessary. For example, in another embodiment of the present invention, the
medial
member 732 of the frame may have a length that is adjustable during a surgical
procedure,
which increases or decreases the distance between the transverse members 733.
The
medial member 732 may comprise a first portion that fits within, or adjacent
to, a second
portion. The medial member may further comprise a rack and pinion system,
threads, or
other means for altering the length of the medial member 732 to provide a
desire amount
of distraction between vertebrae VS, VM, VI. As will be appreciated by one of
skill in the
art, the frame may have different shapes and sizes. For example, in another
embodiment,
23
CA 03001898 2018-04-12
the frame 730 may comprise two medial members. Each medial member 732 may have
a
length that is independently adjustable.
Once the frame is in place, the guide 710 is interconnected to the frame. In
one
embodiment, at least a portion of the guide 710 is adapted to contact a cut
surface 750 of a
patient's vertebrae. Another portion of the guide 710 may have patient-
specific surface
adapted to conform to an uncut portion of the patient's vertebrae.
The guide includes cutting tracks 720. The tracks 720 are similar to the other
slots
described herein, including, without limitation, slots 20, 120, 320. After the
guide is
interconnected to the frame, the tracks are used to guide cuts into the
vertebrae along a
predetermined trajectory. Each track 720A, 720B may have a unique patient
specific
shape. Further, track 720A may have a size and width adapted to receive a
specific tool
that is different than the tool associated with track 720B.
In one embodiment, the guide 710 includes two tracks to separate the pedicle
from
the medial vertebrae VM. The tracks may enable the separation of the pedicle
in a single
cut. The guide 710 may include apertures to guide cuts in other portions of
the vertebrae
VS, VM, and VI similar to guides 510. 610.
Although not illustrated, the guide 710 may also include cannula similar to
cannula
16, 416 describe above. The cannula may receive a fixture (similar to fixture
434) to
interconnect the guide 710 to the targeted vertebrae VM. Optionally, the
fixture may be
placed in a portion of the vertebrae, such as the pedicle, planned for removal
by cuts
guided by the tracks 720. In this manner, after the cuts are completed, the
guide 710 can
be removed from the frame to remove the severed portions of the pedicle. In
another
embodiment, the cannula is adapted to guide an instrument, such as a boring
device.
Referring now to Figs. 11-12, embodiments 810A, 810B of guides of embodiments
of the present invention are illustrated. The guides are adapted fit to a cut
surface 850 of a
vertebrae VM that has been formed by removing a portion of the vertebrae. The
surface
850 may be formed by a cut guided by another any other guide of the present
invention.
The guides 810A, 810B may also include patient-specific surfaces 814 that are
adapted to
substantially conform to predetermined portions of the vertebrae. A first
portion 814A
may be adapted to contact and substantially conform to a cut surface 850 of
the patient's
anatomy. A second portion 814B of the guide may include patient specific
contours
adapted to substantially conform to an unaltered portion of the patient's
anatomy. The
second portion 814B may generally hook around the patient's anatomy. In this
manner,
24
CA 03001898 2018-04-12
=
the second portion 814B contacts a different plane of the patient's anatomy
compared to
portion 814A.
Although the guides 810 illustrated in Figs. 11-12 include two slots, it will
be
appreciated that the guides may include any number of slots. The slots may
also have
different shapes, including arcuate shapes. Further, the guides 810 may
include slots to
target both sides of a vertebra. In another embodiment, different guides 810
may be
formed to target each of the posterior sides of the vertebrae. In this
embodiment, the two
guides for each side of the vertebrae may be keyed. The keys enable the guides
to be
interconnected together during the procedure. In this manner a guide 810 can
be
assembled that targets both sides of the vertebrae while still protecting
neural elements.
The keys may optionally be adapted to require a specific assembly sequence of
the
individual guides.
A recess 854 may be formed in a portion of the guides 810. The recess 854 has
a
cross-sectional shape selected to at least partially wrap around a neural
element N, such as
the spinal cord, of the patient. In one embodiment, the recess 854 has a shape
similar to a
or a vaulted ceiling. The recess 854 includes an interior surface 856,
illustrated in
Fig. 11A, that is spaced from an interior surface of the slots 820. In this
manner, the
recess 854 protects the neural element N from inadvertent damage as a tool is
guided in
the slot 820 to form a cut in the vertebrae.
Referring now to Fig. 12, guide 810B is similar to guide 810A. Additionally,
guide 810B includes a second recess 854A which is shaped to protect a second
neural
network. N2, such as a nerve root, from damage.
Referring now to Figs. 13A-13E, another guide 910 of an embodiment of the
present invention is illustrated. Guide 910 is similar to guides 810A, 810B.
In one
embodiment, the guide 910 is adapted for use to make final cuts 950 required
during a
pedicle subtraction osteotomy (or APSO). Guide 910 generally comprises a
radiused
corner 958, a recess 954, and guide slots 920. After portions of the vertebrae
have been
removed exposing a neural network N, such as the spinal cord, the guide 910 is
placed
between the spinal cord and the vertebrae VM. The radiused corner 958 of the
guide is
shaped to push the neural elements to create a space for the guide between the
spinal cord
and the vertebrae. The neural element N is then received in the recess 954
which protects
the neural element from damage during cutting performed using the slots 920 of
the guide
910. The guide includes patient-specific features 914 that allow it to fit in
a predetermined
CA 03001898 2018-04-12
location. These features may match with the patient's anatomy (the anterior
portion of the
spinal canal) or may match to the cutting surfaces 950 generated with earlier
guides.
The slots 920 are similar to slots of all embodiments of guides of the present
invention described herein. Further, sleeves may be placed in the slots 920 to
prevent
damage or alteration of the slots by cutting tools used in the surgical
procedure. The slots
may align with previously completed cuts. In this manner, new cuts guided by
the slots
will intersect the previous cuts so that a portion of the vertebrae may be
removed. In one
embodiment, the slots 920 are aligned to complete a cut to remove a medial
portion of the
vertebral body.
to Referring now
to Figs. 14-19, embodiments of models of the present invention are
illustrated. The models are adapted for use during a surgical procedure, such
as an
osteotomy, as a reference for the surgeon. The models may be designed with
patient-
specific features and apertures or surfaces aligning with operations to be
performed during
the surgical procedure. The models include presurgically planned corrections
to the
patient's anatomy. For example, the models may include indications of angles
and starting
locations of multiple cuts required to make planned corrections to patient's
alignment.
The models can include surfaces and indications aligning with cuts of any size
and shape,
including cuts that are straight, concave, convex, curvilinear, or 'chevron'
shaped.
Further, the models can be designed to be modular such that separate portions
are
interconnected to form the finished model during a surgical procedure. This
may be
beneficial for models designed to fit around, or conform to, portions of the
patient's
anatomy with complex exterior contours.
Referring now to Figs. 14A-14E, an embodiment of a model 1002 of the present
invention is illustrated. The model 1002 is designed to include patient
specific surfaces
1014 substantially conforming to a portion of the posterior surface of a
vertebrae V. In
one embodiment, the model is adapted to at least partially fit around a
portion of the
vertebrae that is planned to be removed during the surgical procedure. In
another
embodiment, at least a portion of the model is adapted to substantially
conform to, or
"hook" to, a predetermined portion of the patient's anatomy, such as the
vertebrae. Said
another way, the model may be adapted to bias into a predetermined orientation
with
respect to the patient's anatomy. Accordingly, the material of the model 1002
may be
selected to allow a surgeon bend or stretch the model 1002 to hook around the
patient's
anatomy. In one embodiment, the model 1002, or portions thereof, may be
manufactured
26
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from a material that is at least partially flexible or deformable. In another
embodiment,
the model is manufactured from a material with shape memory, such as Nitinol.
The model 1002 is adapted to indicate entry points and angles of the planned
cuts.
In one embodiment, the model includes indicia that indicated the entry points.
In another
embodiment, at least one exterior surface of the model is parallel to the
plane of a planned
cut. For example, in the embodiment of the model 1002 illustrated in Fig. 14E,
exterior
surface 1013 is substantially parallel to the plane of a cut planned to remove
the spinous
process S. Although not illustrated, the model may include slots and eannula
to guide cuts
and bores into portions of the vertebrae V. As will be appreciated, the size
and shape of
the model 1002 may vary as planned to guide any variety of cuts. For example,
if the
thickness of the model 1002 illustrated in Fig. 14E is increased, less of the
spinous process
S will be removed by a cut guided by surface 1013. In the alternative, more of
the spinous
process S can be removed by decreasing the height of the model 1002.
Referring now to Figs. 15A-15F, still another model 1102 of the present
invention
is illustrated. Model 1102 is adapted for use in an asymmetrical pedicle
subtraction
osteotomy in one embodiment of the present invention. Model 1102 is similar to
model
1002. Thus, the model may include indicia and other indications of entry
points and
angles of cuts. However, model 1102 further includes an aperture 1128 that
fits around a
portion of the vertebrae planned to be removed. In one embodiment, the
aperture 1128 has
a shape that is asymmetric around a vertical axis substantially parallel to
the shorted sides
of the model 1102. The aperture 1128 thus forms a window that indicates the
bone
intended for removal during the asymmetrical pedicle subtraction osteotomy. In
one
embodiment, proximal surface 1113 of the model 1102 is about parallel to the
plane of a
cut planned to remove a predetermined portion of the spinous process S.
As will be appreciated, the model 1102 and the aperture 1128 may be of any
size
and shape. The model also includes a variety of patient matched surfaces 1114
associated
with portions of the patient's anatomy similar to the patient specific
surfaces 1014 of
model 1002. Further, the patient specific surfaces may be formed in voids 1117
formed in
the model. The voids are adapted to align the model with the patient's
anatomy. The
model 1102 may further include projections 1119 with patient specific surfaces
1114
adapted to mate with portions of the patient's anatomy. The combination of
voids 1117
and projections 1119 may decrease the possibility of improper placement of the
model
1102 in relation to the patient's anatomy.
27
CA 03001898 2018-04-12
Figs. 16A-16C illustrate a model 1102A of another embodiment of the present
invention. Model 1102A is similar to model 1102. However, the aperture 1128A
has a
different shape that is substantially symmetric about a vertical axis. The
aperture 1128A
thus forms a window that indicates the bone intended for removal. As will be
appreciated,
the model and the aperture 1128A may be of any size and shape. In one
embodiment,
model 1102A is thicker than model 1102. Accordingly, model 1102A may be
designed
for a procedure in which less of the spinous process S is planned to be
removed compared
to a procedure using model 1102.
The model 1102A also includes a variety of patient specific surfaces
associated
with portions of the patient's anatomy similar to the patient specific
surfaces 1114 of
model 1102. Further, voids and projections may be formed on the model 1102A
similar to
the voids and projections of model 1102 described above.
Referring now to Figs. 17A-17E, still another model 1202 of an embodiment of
the
present invention is illustrated. The model 1202 generally comprises a first
portion 1208
and a guide portion 1210. In one embodiment, the first portion and the guide
portion are
integrally formed as one piece. In another embodiment, portions 1208, 1210 are
individual pieces adapted to be interconnected before or during a surgical
procedure. The
features 1260, 1262 are provided to align and interconnect the guide portion
1210 to the
first portion 1208. In one embodiment, the features comprise projections 1260
formed on
one of the portions adapted to be retained in bores 1262 formed in the other
portion.
Although the projections are illustrated on the guide portion 1210 and the
bores are
illustrated on the first portion 1208, it will be appreciated the guide
portion and the first
portion may each comprise projections and corresponding bores. Further, other
features
adapted to interconnect and/or align portions 1208, 1210 are contemplated and
may be
used with the model 1202.
The first portion 1208 is similar to models 1002-1102 described above.
Accordingly, the first portion generally includes patient specific surfaces
1214, voids
1217, protrusions 1219, and an aperture 1228 that are the same as (or similar
to) the
corresponding features of other models and guides described herein.
The guide portion 1210 generally includes tracks 1220 for guiding cutting
tools,
similar to the slots of all embodiments of the guides described herein. Thus,
the tracks
1220 may be of any size and shape. Additionally, the tracks may be sized to
receive
sleeves and may include stops and keys to guide a direction of use of the
cutting tool or
28
CA 03001898 2018-04-12
limit the depth of insertion of the tool. Further, the tracks 1220 may have an
asymmetric
alignment.
Referring now to Figs. 18-19, still more embodiments of models 1302A, 1302B of
the present invention are illustrated. The models are adapted to dock to a
frame 1330.
The frame 1330 may be the same as, or similar to, frames 330, 730 described
above.
Accordingly, models 1302 are adapted to fit with either pre-existing or
planned pedicle
screws 1334. The models may optionally contact a surface 1350 of the medial
vertebrae
VM prepared in a previous cutting procedure.
The models 1302A, 1302B generally include apertures 1328 and voids 1317 for
interconnection to the frame. In one embodiment, the model 1302A includes a
closed
aperture 1328. Accordingly, the model 1302A is generally interconnected to a
medial
portion of the frame 1330 before the frame is interconnected to the pedicle
screws 1334.
Further, the models may include a recess 1354 similar to recess 854, 954
described
above. The recess has a cross-sectional shape similar to at least partially
wrap around a
neural element, including the spinal cord of the patient. The models may also
include
indicia that indicate a location to begin a cut and an angle of the cut.
Model 1302A is generally comprised of two portions 1307A, 1307B. Each portion
includes a leg or medial surface 1309 that indicates an angle of a planned
cut. For
example, medial surfaces 1309 are generally in a plane that is parallel to a
place formed by
a planned cut into the vertebrae. Thus, the space between portions 1307A,
1307B
generally indicates the shape of a portion of the vertebrae VM that will be
removed. In
one embodiment, the medial surface 1309 includes a distal portion with patient
specific
contours 1314. The patient specific contours may substantially conform to a
cut portion
1350 of the patient's anatomy. Optionally, the distal portion of medial
surface 1309 may
be adapted to contact and substantially conform to an uncut portion of the
patient's
anatomy.
In contrast, model 1302B comprises one piece. Angles of planned cuts are
indicated by legs or exterior surfaces 1309 of the model 1302B proximate to
the superior
and inferior vertebrae VS, VI. Accordingly, the shape of the model generally
indicates the
shape of a portion of the vertebrae VM planned for removal. In addition, model
1302B
has a void 1317 with an opening for interconnection to the frame 1330.
Accordingly, the
model 1302B may be added and removed from the frame without disassembling the
frame
1330. In one embodiment, distal portions of the surface 1309 include patient
specific
contours 1314.
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Referring now to Figs. 20A-20F, still another embodiment of a model 1402 of an
embodiment of the present invention is illustrated. Model 1402 is a patient
specific three-
dimensional model of grouping of vertebrae of the patient. The model is
created for use in
planning and performing a surgical procedure that includes removal of a
section 1405 of
the patient's spine. In one embodiment, the model is adapted for a spinal
osteotomy
procedure.
The section 1405 of the spine to be removed during the surgery is formed as a
separate piece from other portions of the model. A handle may be
interconnected to the
removable section 1405. In this manner, the removable section 1405 may be
separated
.. from, or returned to, a position in the model 1402.
The removable section 1405 may be used as a template or measurement jig during
surgery. A portion of the removable section 1405A could be cut away to avoid
contact
with neural elements of the patient during surgery, as illustrated in Fig.
20C. The removed
portion may conform to portions of the vertebrae of the patient removed during
the
surgery. Thus, the distal end of the modified section 1405A can be adapted to
substantially align with surfaces of the target vertebrae.
The superior VS and inferior VI portions of the spine may also be formed as
separate pieces. Thereafter the superior and inferior portions may be
interconnected. In
one embodiment, spine portions VS, VI are interconnected by a hinge 1464.
However, it
will be appreciated by one of skill in the art that other means may be used to
interconnect
the superior and inferior spine portions. For example, in another embodiment,
a flexible
member can be used to interconnect spine portions VS, VI. In another
embodiment, a ball
and socket joint may be provided to interconnect the spine portions VS, VI.
After the removable section 1405 of the model is withdrawn, the superior and
inferior spine portions VS, VI can be repositioned, as illustrated in Fig.
20D, to
demonstrate the corrected alignment of the spine provided by the procedure.
The model
1405 may indicate that different, or additional, procedures will be required
to correct a
spinal abnormality.
To further visualize the alignment of the patient's spine before and after the
planned procedure, indicators 1466A, 1466B may be interconnected to the
superior and
inferior spine portions VS. VI, respectively, as illustrated, for example, in
Figs. 20E-20F.
In one embodiment, the indicators 1466 comprise rods with a curvilinear shape.
It will be
appreciated that the indicators may comprise different forms. The indicators
simulate how
CA 03001898 2018-04-12
the sagittal alignment of the patient's spine is altered by the pre-surgically
planned
osteotomy angles.
A variety of patient specific verification tools, illustrated in Figs. 21-24,
can be
pre-operatively planned and manufactured in order to aid in verifying final
sagittal and/or
coronal alignment and/or confirm screw placement. The verification tools are
unique to
each patient and may contain patient matching surfaces, implant contacting
surfaces,
and/or capability to mate with a guide. The verification tools of the present
invention
described in conduction with Figs. 21-24 offer visual or tactical feedback to
the surgeon
during or after a surgical procedure.
Referring now to Figs. 21-22, tools 1501A, 1501B of embodiments of the present
invention are illustrated. The tools are adapted to verify coronal alignment
during a
surgical procedure. Said another way, the tools 1501 are used by a surgeon to
verify that
planned correction of the spine was substantially generated.
The tools 1501A. 1501B are designed using patient specific data and may be
manufactured by any method. The tools 1501 generally comprise armatures 1570
extending from a medial body 1572. The medial body 1572 simulates a planned
coronal
alignment.
Some of the armatures may be interconnected to portions of the patient's
anatomy.
In one embodiment, illustrated in Figs. 21A-21D, the armatures may be
interconnected to
pediele screws positioned in at least one of the ilium and the sacrum. In
another
embodiment, the tool 1501B is interconnected to only the sacrum.
The screws may be from a previous procedure or placed specifically to
interconnect the tools 1501 to the patient's anatomy. Optionally, in another
embodiment,
the medial body 1572 includes patient specific contact surfaces selected to
substantially
match the posterior surface of the sacrum. Thus, the medial body 1572 may be
retained on
the sacrum with or without the use of pedicle screws.
An armature 1570A may be adapted to extend from the medial body to one or
more superior vertebrae. The armature 1570A may have a non-linear shape
adapted to
substantially align with predetermined portions of the superior vertebrae when
the planned
correction of the spine is generated. In one embodiment, the armature 1570A is
adapted to
align with a posterior portion of the spinous processes S of number of
superior vertebrae.
Optionally, the armature 1570A may contact portions of the superior vertebrae
when the
planned correction is generated. In one embodiment, the tool 1501A comprises
five
31
CA 03001898 2018-04-12
armatures 1570 extending from the medial body 1572. In another embodiment, the
tool
1501B includes three armatures 1570 extending from the medial body.
In another embodiment, the tool 1501 includes an electronic alignment
indicator.
The electronic indicator may comprise a light source or a laser aligned to
produce a visible
beam indicating the planned position of one or more vertebrae. The electronic
indicator
may be positioned in the medial body or on an armature.
Yet another embodiment of a tool 1601 of an embodiment of the present
invention
is illustrated in Figs. 23A-23E. The tool 1601 is similar to tools 1501 and is
also used to
verify coronal alignment during a surgical procedure. The tool generally
comprises an
armature 1670 interconnected to a guide 1646. In one embodiment, the armature
1670
extends from a medial body 1672 of the guide. The medial body 1672 may include
a
fixture for interconnecting the armature 1670 to the guide 1646. The guide may
be a
sacroiliac guide. In one embodiment of the present invention, the guide 1646
is similar to
guide 246 described above. Alternatively, in another embodiment, the guide
1646 is one
of the guides described hereinafter in conjunction with Figs. 25-31.
The armature 1670 may be integrally formed with the guide 1646. Optionally,
the
armature and the guide may be formed as separate pieces and interconnected
before or
during the surgical procedure. The curvilinear shape of the armature 1670 is
adapted to
indicate the planned sagittal and coronal alignment of patient's spine after
the surgical
procedure is completed, as illustrated in Figs. 23D-23E. Similar to armature
1570A
described above, the armature 1670 has a length selected to extend proximate
to a number
of superior vertebrae. The armature may have a shape that is proximate to, or
contacts,
portions of a number of vertebrae.
Referring now to Figs. 24A-24B an embodiment of an alignment assembly 1700 of
.. an embodiment of the present invention is illustrated. The assembly 1700
generally
comprises armatures 1770 interconnected to a medial body 1772. The medial body
may
have a predetermined shape and size. In one embodiment, the medial body 1772
has an
arcuate shape. The medial body 1772 includes indicia 1774 that indicate a
relative
alignment of the patient's vertebrae, such as interior VI and superior VS
vertebrae
proximate to medial vertebrae VM. The indicia may comprise a series of lines
that
optionally are graduated to indicate predetermined angles or distances. The
medial body
1772 may be an existing tool, such as the scale of a protractor or a ruler. In
one
embodiment, the indicia 1774 include projections 1776 indicating a planned
correction.
32
CA 03001898 2018-04-12
At least one of the armatures 1770 is moveably interconnected to the medial
body
1772. In one embodiment, the armatures 1770 include a proximal portion forming
a
pointer. The pointer 1771 indicates the position of the armature on the
indicia of the
medial body 1772.
A distal portion of each armature is interconnected to fixtures (not
illustrated)
placed in vertebrae of the patient. The fixtures may comprise pedicle screws.
Optionally,
the armatures 1770 may have features adapted to be received directly in a
cannula formed
in vertebrae. In one embodiment, one armature 1770 is interconnected an
inferior
vertebrae VM and a second armature is interconnected to a superior vertebrae
VS.
However, other interconnection locations of the armatures are contemplated.
For
example, in one embodiment of the present invention, one of the armatures 1770
is
interconnected to a portion of the medial vertebrae VM.
In use, the alignment assembly 1700 may provide a first reading before the
alignment of the spine is altered, as shown in Fig. 24A. After cuts 1750 are
formed in the
medial vertebrae VM, the alignment of the superior and inferior vertebrae VS,
VI can be
altered, drawing two cuts edges 1750 of the medial vertebrae VM closer
together. A
second reading of the alignment of the spine is then provided by the alignment
assembly
1700, as shown in Fig. 24B.
Referring now to Figs. 25-26 in detail, a patient-specific guide 1810 of an
embodiment of the present invention is illustrated. The guide 1810 may
comprise a
spanning member or medial body 1812, arms 1814, a cannulae 1816, and a patient-
matched leg 1824. In one embodiment of the present invention, the guide 1810
includes
two arms 1814, two cannulae 1816, and two legs 1824. However, the guide 1810
of the
present invention may include any number of cannulae and legs. The cannulae
1816 and
legs 1824 may all have different lengths. Additionally, the angle and
orientation of each
cannulae and leg can be varied to match the anatomy of the patient, or to
avoid a portion
of the patient's anatomy. In one embodiment of the present invention, the
cannulae 1816
have a generally cylindrical shape.
Although the guide 1810 illustrated in Figs. 25-26 generally shows the
cannulae
1816 and legs 1824 interconnected with two arms 1814, one of skill in the art
will
appreciate that the cannulae 1816 and legs 1824 may be interconnected in any
number of
ways. For example, in one embodiment, the cannulae 1816 may be interconnected
by a
curved medial body. Optionally, in one embodiment, the cannulae 1816 and legs
1824
33
CA 03001898 2018-04-12
may be formed as separate pieces that are individually located with respect to
the patient's
anatomy and then interconnected during the surgical procedure.
The cannulae 1816 are configured to contact one or more of the lamina, pars
interarticularis, and aspects of the transverse process and the superior
articular process of
the patient. Cutouts 1817 may optionally be formed on a portion of the
cannulae 1816 to
prevent the guide 1810 from contacting the spinous process of the patient, or
to avoid
other patient anatomy. In alternate embodiments, cutouts 1817 may comprise one
or more
patient-matched surfaces or features for contacting in a complementary fashion
the
surrounding patient anatomy. In certain embodiments, cutouts 1817 may be
oriented to
achieve greater visibility to the surgeon/user, or to facilitate placement of
one or more
instruments or other devices as described herein. In further alternate
embodiments, cutouts
1817 are not provided with the cannulae. In one embodiment, the cutouts 1817
may be
adapted to provide a patient specific contour to match the spinous process or
other unique
patient anatomical feature and provide yet another surface for ensuring
alignment and
seating of the guide.
The cannulae may include a generally hollow bore 1820 adapted to guide
instruments and fixation devices in the cortical trajectory. The bore 1820 of
each cannulae
1816 can have an internal diameter that corresponds to a particular instrument
or fixation
device to prevent the use of the incorrect instrument or device. Thus, the
dimensions of
the bores of two cannulae may be different. The internal diameter of the bore
1820 may
be selected to prevent the instrument or device from advancing into the
cannulae 1816
beyond a predetermined distance, thereby providing a hard stop. Alternatively,
a
protrusion, key, notch, or void may be formed on the cannulae or in the bore
to one or
more of: prevent the use of the incorrect instrument or device; prevent an
incorrect
orientation of the correct tool or device; and prevent over insertion of the
tool or device.
Further, the cannulae 1816 may have a varying length and may be made longer or
shorter depending on the geometry of the cannulae 1816, the patient's anatomy,
the
purpose of the guide 1810, etc. For example, if a greater depth of a
particular instrument
or fixation device is required, the cannulae 1816 may be shorter to
accommodate further
penetration of the instrument or fixation device into patient's vertebrae.
The guide 1810 may include a patient-matched leg 1824 adapted to contact
predetermined portions of the patient's anatomy. In one embodiment, the leg
1824
contacts one or more of the inferior articular process, lamina, and the
transverse process.
34
CA 03001898 2018-04-12
=
Optionally, the guide may include two or more legs. In one embodiment, the leg
comprises a distal portion 1824A and a proximal portion 1824B. As will be
appreciated,
the legs 1824 may also extend from the cannulae 1816. For example, in one
embodiment,
the leg comprises only a distal portion 1824A extending from the cannula 1816.
Additionally, or alternatively, patient-specific contact surfaces 1818, 1826
may be
formed on any patient-contacting surfaces of the cannulae 1816 and/or the legs
1824,
respectively. The surfaces 1818, 1826 provide a plurality of patient-specific
contours for
matching with a plurality of anatomical features. Further, the lower, patient-
contacting
surfaces 1818, 1826 may comprise dynamic contours having multiple compound
radii.
Accordingly, the surfaces 1818, 1826 are substantially congruent with the
corresponding
anatomical features of the vertebrae or other anatomical feature of the
patient. Further, the
surfaces 1818. 1826 may contact or protrude around one or more of, but not
limited to, the
group comprising: the medial side of the inferior articular process, the
lateral sides of the
lamina, the junction between the pars and the transverse process, and other
anatomical
features of the patient.
The guide 1810 may further comprise slots 1830 formed in the medial body 1812,
arms 1814, cannulae 1816, or the legs 1824. The slot 1830 may be a cutting
slot to direct
the path of a blade or other cutting instrument as will be appreciated by one
of skill in the
art. In other embodiments, the slot 1830 may be adapted to receive a
measurement aid or
tool for facilitating the surgeon/user in identifying landmarks, surrounding
boney
anatomy, placement of implanted devices, or for surgical planning.
Alternatively, the slot 1830 may be adapted to receive one or more secondary
or
tertiary cannulae 1840, 1850 as further described in conjunction with Fig. 31.
In certain
embodiments, the tertiary cannulae 1840, 1850 may further comprise a patient-
matched
surface or feature for contacting a particular patient anatomical surface or
feature. In
alternate embodiments, the tertiary cannulae are generally smooth and do not
comprise
patient-matched surfaces or features.
Referring now to Figs. 27A-C, another patient-specific guide 1910 of an
embodiment of the present invention is illustrated. The guide 1910 comprises a
medial
body 1912 and at least one cannulae 1916. In one embodiment, the guide 1910 is
formed
as two separate pieces that may be individually positioned in contact with a
predetermined
feature of the patient's anatomy and then interconnected during the surgical
procedure.
The two portions 1912A, 1912B of the medial body are adapted be
interconnected. In one
CA 03001898 2018-04-12
=
embodiment, the medial body 1912B includes a coupling 1913 adapted to
releasably
interconnect the individual pieces of the guide 1910 together. Accordingly, in
one
embodiment, the two portions of the guide may he interconnected by positioning
the
coupling 1913 in a corresponding void in medial body 1912A. The coupling may
be held
in the void by friction. Additionally, or alternatively, a biasing force may
be provided to
retain the coupling 1913 in the void. In one embodiment, the coupling and void
comprise
a snap. In another embodiment, the medial body may include magnets.
Optionally, in still
another embodiment, the medial body portions 1912A, 1912B may be
interconnected by a
flexible or expandable member, such as a hinge or a biasing member of any
type,
including a spring. It will be appreciated by one of skill in the art that the
medial body
portions 191 2A, 1912B may be interconnected by any other suitable means.
Optionally,
in another embodiment of the present invention, the guide 1910 is formed as
one integral
piece.
The cannulae 1916 are the same as or similar to the cannulae 1816 described
above
in conjunction with Figs. 25-26. In one embodiment, the cannulae 1916 has a
generally
cylindrical shape. In like manner, the cannulae 1916 are configured to contact
one or
more of the patient's lamina, pars, and aspects of the transverse process and
the superior
articular process or other portions of the patient's anatomy. The cannulae may
be formed
without a bore. In another embodiment, the cannulae 1916 may include a bore
1920
similar to bore 1820. The bore 1920 comprises a predetermined internal
diameter that is
adapted to receive a particular instrument or fixation device to prevent the
use of the
incorrect instrument or device. The internal diameter of the bore 1920 may be
selected to
prevent the instrument or device from advancing into the cannulae 1916 beyond
a
predetermined distance, thereby providing a hard stop. Additionally, the bore
1920 may
have a shape adapted to align the tool or fixation device in a predetermined
orientation of
use. Further, the cannulae may be of any length based at least in part on the
specific
patient's anatomical features, preferences of the surgeon, orientation of the
guide 1910,
and the type of tool or fixation device associated with the cannulae 1916.
Additionally, or alternatively, patient-specific contact surfaces may be
formed on
any patient-contacting surfaces 1918 of the cannulae 1916 and/or the
contacting surfaces
1926 of the medial body 1912. The surfaces 1918, 1926 provide a plurality of
patient-
specific contours for matching with a plurality of anatomical features, as
described in
greater detail above. The surfaces 1926 of the medial body 1912 may contact at
least the
front of the spinous process S. The surfaces 1918 of the cannulae 1916 are
adapted to
36
CA 03001898 2018-04-12
contact or protrude around one or more of, but not limited to, the group
comprising: the
medial side of the inferior articular process, the lateral sides of the
lamina, the spinous
process, and the junction between the pars and the transverse process, and
other
anatomical features of the patient. These patient-contacting surfaces 1918,
1926 help
.. position the guide 1910 and keep it in position in a predetermined position
and orientation.
Referring now to Figs. 28A-B, a patient-specific guide 2010 of still another
embodiment of the present invention is illustrated. The guide 2010 generally
comprises a
cannulae 2016 and one or more legs 2024. The cannulae 2016 are the same as or
similar
to the cannulae described above in conjunction with Figs. 27-28. Although only
one
cannula 2016 is illustrated in Fig. 28, one of skill in the art will
appreciate that the guide
2010 may have any number of cannulae. The cannulae 2016 includes a bore 2020,
the
same as or similar to bores 1820, 1920, which comprises a predetermined
internal
diameter to receive a particular instrument or fixation device. Accordingly,
the bore 2020
may prevent the use of the incorrect instrument or device and prevent to
incorrect use of
the instrument or device. Thus, the internal diameter of the bore, the shape
of the bore,
and/or a feature formed on or in the bore may be selected to prevent the
instrument or
device from advancing into the cannulae 2016 beyond a predetermined distance,
thereby
providing a hard stop.
The length of the cannulae 2016 may also be increased or decreased based at
least
in part on the instrument or device associated with the cannulae 2016, the
orientation of
the guide with respect to the patient's anatomy, and preferences of the
surgeon. Thus, the
cannulae may be adapted to prevent the instrument or fixation device from
advancing too
far into the boney anatomy of the patient.
Additionally, or alternatively, the cannulae 2016 may include a second bore.
The
second bore may be oriented in a different trajectory for placement of a
temporary fixation
device. Optionally, the cannulae may include a track or slot adapted to guide
an
instrument operable to remove a predetermined portion of a vertebrae. The slot
may
include patient-specific depth control, angle control, and orientation. The
slot may be the
same as, or similar to, any of the slots described herein such as slots 20,
120, 320, 420,
520, 720, 820, or 1220.
In one embodiment of the present invention, the cannulae 2016 has a length
such
that the distal or terminal end 2018 of the cannulae 2016 does not contact the
patient's
anatomy. Said another way, the terminal end 2018 of the cannulae 2016 is
adapted to float
above a predetermined portion of the patient's anatomy. In another embodiment
of the
37
CA 03001898 2018-04-12
present invention, the cannulae 2016 has a different length such that the
terminal end 2018
of the cannulae 2016 intentionally contacts a predetermined portion of the
patient's
anatomy. Continuing this example, patient-specific contact surfaces may be
formed on the
terminal end 2018 of the cannulae 2016. Thus, the terminal end 2018 of the
cannulae
2016 may optionally provide still another guide surface to align and/or
stabilize the guide
2010 in a predetermined orientation during a surgical procedure.
The legs 2024 of the guide 2010 may each comprise a different length.
Additionally, the position and alignment of the legs 2024 with respect to the
cannula 2016
may vary based on patient specific anatomical features, a planned orientation
of the guide
2010, or a preference of the surgeon. The legs 2024 are adapted to contact
predetermined
portions of the patient's anatomy. In one embodiment, one or more of the legs
2024 may
be adapted at least partially conform to, or hook around, a predetermined
portion of the
patient's anatomy. Accordingly, the guide 2010, or portions thereof, may be
made of a
material selected to allow a surgeon bend or deform the guide 2010 to fit
around the
patient's anatomy. In one embodiment, the legs 2024, or portions thereof, are
manufactured from a material that is at least partially flexible or
deformable. In another
embodiment, at least a portion of the legs 2024 are manufactured from a
material with
shape memory, such as Nitinol. Accordingly, the legs may provide a bias force
to
releasably retain the guide 2010 in a predetermined alignment with respect to
the patient's
anatomy.
Accordingly, in one embodiment, at least one of the legs includes a curved
shape,
or a cutout similar to cutouts 1817 described above in conjunction with Figs.
25-26, to
prevent unintended or inadvertent contact between the guide 2010 and the
spinous process
S or another anatomical feature of the patient. Alternatively, in another
embodiment, at
least one of the legs may include a curved shape or cutout with patient-
matched surfaces
adapted to create still another patient specific contact surface to one or
more of align and
stabilize the guide 2010.
In one embodiment, at least one of the legs 2024 contacts one or more of the
group
comprising the inferior articular process, lamina, superior articular process.
the transverse
process, and another anatomical feature. The terminal ends 2026 of the legs
2024 may
include patient-specific contact surfaces the same as or similar to contact
surfaces 1826,
1926 described above in conjunction with Figs. 25-27. Additional patient
specific contact
surfaces may also be formed on one or more other surface of the legs 2024.
38
CA 03001898 2018-04-12
Referring now to Figs. 29A-C, another patient-specific guide 2110 of another
embodiment of the present invention is illustrated. The guide 2110 generally
comprises a
medial body 2112 and at least one cannulae 2116. The medial body 2112
comprises a
distal surface 2113 adapted to contact predetermined portions of the patient's
anatomy. In
one embodiment, the distal surface 2113 is adapted to contact one or more of
the group
comprising the inferior articular process, lamina, spinous process, pars, the
transverse
process, and other features of the patient's anatomy. Thus, the distal surface
2113 of the
medial body 2112 provides a patient specific surface to align the guide 2110
in a
predetermined orientation. Optionally, one or more of the lateral surfaces
2111 may have
patient specific shapes adapted to contact, or interconnect to, other portions
of the patient's
anatomy. For example, the guide 2110 may include extensions or legs, similar
to legs
2024, adapted to hook around, portions of the patient's anatomy. The legs may
be made
of a flexible or deformable material, including Nitinol. In one embodiment,
the legs are
adapted to provide a bias force to "hook" the guide in a predetermined
orientation with
respect to the patient's anatomy.
Further, the surface 2113 may comprise two or more surface portions 2113A,
2113B adapted to contact different portions of the patient's anatomy.
Accordingly, the
surfaces 2111, 2113A, 2113B can form a complex shape selected to provide a
substantially tight fit of the guide 2110 to the patient's anatomy to one or
more of: prevent
unintended or inadvertent movement of the guide 2110 during the surgical
procedure and
position the guide 2110 in a predetermined position with respect to the
patient's anatomy.
The distal surface 2113 may further include a relief portion 2115 to prevent
unnecessary
contact with the patient's anatomy to avoid unnecessary or unintended tissue
dissection or
damage. Optionally, one or more of the surfaces 2111, 2113A, 2113B may have a
shape
or protrusion adapted to displace soft tissue.
The cannula 2116 is the same as or similar to the cannulae described above in
conjunction with Figs. 25-28. One of skill in the art will appreciate that the
guide 2110
may have any number of cannulae. In one embodiment of the present invention,
the guide
2110A includes two cannulae 2116, 2116A. Further, the cannulae may each have a
different orientation to target different portions of the patient's anatomy.
The cannulae
generally pass from the proximal surface of the guide 2112 to the distal
surface 2113.
Further, although illustrated protruding from the proximal surface of the
guide 2112, one
of skill in the art will appreciate that the cannula 2116 may terminate at a
point
substantially level with the proximal surface of the guide. Additionally, the
cannula may
39
CA 03001898 2018-04-12
have any predetermined orientation with respect to the medial body 2112 of the
guide
2110. In one embodiment, the cannula has an orientation that passes through
the proximal
surface and the distal surface of the guide. In another embodiment of the
present
invention, at least one end of the cannula 2116A passes through a lateral
surface 2111 of
the guide 2110.
The cannulae 2116, 2116A include a bore 2120 similar to bores 1820, 1920,
2020.
The bore 2120 comprises a predetermined internal diameter or shape to receive
a
particular instrument or fixation device. Accordingly, the bore 2120 may
prevent the use
of the incorrect instrument or device. The bore 2120 may also be adapted to
prevent the
to improper use of an instrument or device. Thus, the internal diameter or
the shape of the
bore 2120 may be selected to prevent the instrument or deyice from advancing
into the
cannulae 2116 beyond a predetermined distance, thereby providing a hard stop.
In this
manner the cannulae may be adapted to prevent the instrument or fixation
device from
advancing too far into the boney anatomy of the patient.
During a surgical procedure, two or more guides 2110 may be used. As
illustrated
in Fig. 29C, each guide may be positioned in contact with different portions
of the
patient's anatomy. Further, although not illustrated in Fig. 29, the
individual guides
2110B, 2110C can be interconnected together before or during the surgical
procedure.
Accordingly, in one embodiment of the present invention, guides 2110B, 2110C
include a
structure similar to the medial body 1912 described above in conjunction with
Fig. 27
adapted to releasably interconnect the guides together. In another embodiment,
the guides
2110B, 2110C include a structure similar to the arm 1814 to permanently
interconnect the
guides together.
In one embodiment, the guide 2110 may be interconnectable to a frame similar
to
guide 2010. Accordingly, the guide 2110 may be used with one or more frames
330, 730,
1330 before, or after, one or more of guide 310, 710, 1302, and 2010.
Referring now to Figs. 30A-C, a patient-specific guide 2210 of yet another
embodiment of the present invention is illustrated. The guide 2210 generally
comprises a
medial body 2212, a cannulae 2216, one or more legs 2224, and a second leg or
bridge
2230.
The cannulae 2216 may be the same as or similar to the cannulae described
above
in conjunction with Figs. 25-29. Although two cannulae 2216 are illustrated in
Fig. 30, it
will be appreciated by one of skill in the art that the guide 2210 may have
any number of
cannulae. Further, each cannulae 2216 has a predetermined length that may be
shorter or
CA 03001898 2018-04-12
longer than the length of a different cannulae of the guide. The cannulae 2216
may
include a bore 2220 similar to bores 1820, 1920, 2020, 2120. The bore 2220
comprises a
predetermined internal diameter adapted to receive a particular instrument or
fixation
device. Accordingly, the bore 2220 may prevent the use of the incorrect
instrument or
device. The shape and/or the internal diameter of the bore 2220 and the length
of the
cannulae 2216 may be selected to one or more of: prevent the instrument or
device from
advancing into the cannulae 2216 beyond a predetermined distance, prevent the
use of the
incorrect instrument or device, and ensure proper alignment and use of the
correct
instrument or device.
Although illustrated in Fig. 30 as having a generally linear shape, it will be
appreciated by one of skill in the art that one or more of the legs 2224 may
have a
curvilinear shape. Thus, the shape, length, and orientation of the legs may be
customized
to contact predetermined portions of the patient's anatomy while avoiding
contact with
other features of the patient's anatomy. Accordingly, in one embodiment, at
least one of
the legs includes a curved shape, or a cutout similar to cutouts 1817
described above in
conjunction with Figs. 25-26, to prevent unintended or inadvertent contact
between the
guide 2210 and the spinous process, the lamina, or another anatomical feature
of the
patient. Alternatively, in another embodiment, at least one of the legs 2224
may include a
curved shape or cutout with patient-matched surfaces (similar to surfaces 1926
described
above in conjunctions with Fig. 27) adapted to create other patient specific
contact
surfaces to one or more of align and stabilize the guide 2210.
In one embodiment, at least one of the legs 2224 contacts one or more of the
group
comprising the inferior articular process and the lamina. The terminal ends
2226 of the
legs 2224 may include patient-specific contact surfaces the same as or similar
to contact
surfaces 1826 described above in conjunction with Figs. 25-26. Additional
patient
specific contact surfaces may also be formed on one or more other surface of
the legs
2224. Although not illustrated, the contact surfaces 2226 may include
protrusions adapted
to one or more of: align the guide 2210 in a predetermined position with
respect to the
patient's anatomy, prevent unintended or inadvertent movement of the guide
2210 during
a surgical procedure, and displace soft tissue. In one embodiment, the contact
surfaces
2226 comprise relatively thin extensions.
The second legs or bridge 2230 is adapted to contact one or more of the
spinous
process S and the lamina of the patient. In the embodiment of the present
invention
illustrated in Fig. 30, the bridge 2230 extends medially from the cannulae
2216. In
41
CA 03001898 2018-04-12
another embodiment, the bridge 2230 extends medially from the legs 2224. The
bridge
2230 may be formed as a single piece and include a longitudinal cavity. In
this manner,
the longitudinal cavity is adapted to substantially mate with the contours of
a
predetermined portion of the patient's anatomy. In one embodiment, the
longitudinal
cavity is adapted to contact the contours of the spinous process S of a
particular vertebral
body V of the patient. In another embodiment, the bridge 2230 is formed of two
separate
portions 2230A, 2230B. In all embodiments of the present invention, the bridge
2230 may
include one or more contact surfaces 2234 adapted to mate with the contours of
one or
more of the spinous process, the lamina, and other anatomical features. Thus,
the bridge
2230 facilitates one or more of ensuring a predetermined alignment of the
guide 2210 and
preventing inadvertent or unintended movement of the guide 2210 during a
surgical
procedure.
The guide 2210 may also include extensions adapted to hook at least partially
around, or to, a portion of the patient's anatomy. For example, in one
embodiment of the
present invention, one or more of the medial body 2212, the legs 2224, and the
bridge
2230 may have a shape adapted hook to the patient's anatomy. In another
embodiment, a
portion of the guide 2210, such as one of the legs, medial body, or the
bridge, may
comprise a flexible or bendable material as previously described. In use, a
surgeon may
bend or alter the guide 2210 to hook to the patient's anatomy. As will be
appreciated, the
guide 2210 may also include a cutting guide 10. The cutting guide 10 may be
interconnected to any portion of the guide 2210, similar to the cutting guide
10 illustrated
in Fig. 27D.
Referring now to Fig. 31, still another embodiment of a patient-specific guide
2310
of an embodiment of the present invention is illustrated. Guide 2310 is
substantially the
same as guide 1810 described above in conjunction with Figs. 25-26.
Accordingly, the
guide 2310 may comprise a medial body 2312, arms 2314, cannulae 2316, and
patient-
matched legs 2324 the same as (or similar to) body 1812, arms 1814, cannulae
1816, and
patient-matched legs 1824 of guide 1810. In one embodiment of the present
invention, the
guide 2310 includes two arms 2314, two cannulae 2316, and two legs 2324.
However, the
guide 2310 of the present invention may include any number of cannulae and
legs. The
cannulae 2316 and legs 2324 can each have different lengths. Additionally, the
angle and
orientation of each cannulae and legs can be varied to match the anatomy of
the patient.
The guide 2310 may further comprise slots 2330 formed in one or more of the
medial body 2312, arms 2314, cannulae 2316, and the legs 2324. The slots 2330
may be
42
CA 03001898 2018-04-12
cutting slots to direct the path of a blade or other cutting instrument as
described above.
Alternatively, the slots 2330 may be adapted to receive one or more secondary
2340 or
tertiary cannulae 2350.
The secondary and tertiary cannulae 2340, 2350 may be positioned in the slots
2330 to target a predetermined portion of one or more of a second level and a
third level
anatomical feature of the patient. In one embodiment, the cannulae 2340, 2350
are
adapted to target one or more predetermined portions of the cervical spine
(i.e., Cl-S1 and
ilium). The cannulae 2340, 2350 include a bore 2320 the same as or similar to
bores 1820,
1920, 2020, 2120, and 2220 described above in conjunction with Figs. 25-30.
Accordingly, the bore 1820 can guide one or more of a guide wire, a drill bit,
a tap, a
fixation device (such as a screw), and other instrumentation, including
without limitation,
tools for harvesting bone grafts. Further the bore and/or the cannulae 2340,
2350 may
have a length, shape, protrusion, and/or a diameter selected to prevent the
use of the
improper tool or device, prevent improper use of a predetermined tool or
device, and
ensure proper use of the predetermined tool or device.
Optionally, in another embodiment of the present invention, the secondary and
tertiary cannulae 2340, 2350 may include a track or slot. The slot may be
adapted to guide
an instrument operable to remove a predetermined portion of a vertebrae. The
slot may
include patient-specific depth control, angle control, and orientation. In one
embodiment
of the present invention, the slot of the cannulae 2340, 2350 is the same as,
or similar to,
any of the slots described herein. For example, the cannulae 2340, 2350 may
include a
slot similar to slots 20. 120, 320, 420, 520, 720, 820, or 1220.
The ends of the cannulae 2340, 2350 may include patient specific contact
surfaces
as previously described in conjunction with Figs. 25-30. Additionally, the
angle and
orientation of each cannulae 2340, 2350 can be varied to match the anatomy of
the patient.
The tertiary cannula 2350 may be releasably interconnected to a secondary
cannula 2340.
The cannulae 2340, 2350 may be releasably interconnected to the guide 2310
before or
during a surgical procedure. The cannulae 2340, 2350 may include an extension
2344 or
multiple extensions 2344A to engage the slots 2330 formed on the guide 2310.
Each of
the slots 2330 may have a different shape, width, depth, and orientation
adapted to receive
a predetermined cannulae 2340, 2350 in a specific orientation. Alternatively,
in one
embodiment, the cannulae 2340, 2350 are formed with the guide 2310 as one
integral
piece.
43
CA 03001898 2018-04-12
Referring now to Figs. 32A-B, yet another patient-specific guide 2810 of an
embodiment of the present invention is illustrated. In one embodiment, guide
2810
comprises a medial body 2812, at least one cannulae 2816, and a leg 2824. The
cannula
2816 may be the same as, or similar to, the cannulae 1816 described above in
conjunction
with Figs. 25-26. Optionally, the cannula 2816 may be configured to contact
one or more
of the lamina, pars interarticularis, aspects of the transverse process, the
interior articular
process, and the superior articular process of the patient. Cutouts (not
illustrated) may be
formed on a portion of the cannulae 2816 to prevent the guide 2810 from
contacting the
spinous process of the patient, an adjacent vertebrae, or to avoid other
patient anatomy.
In one embodiment, the guide 2810 comprises two cannulae 2816; however, it
will
be appreciated that the guide 2810 may include any number of cannulae. The
cannulae
2816 may have a generally cylindrical shape but other shapes are contemplated.
Each of
the two cannulae 2816 may have a unique orientation and size. The cannulae may
be of
any length based at least in part on the specific patient's anatomical
features, preferences
of the surgeon, orientation of the guide 2810, and the type of tool or
fixation device
associated with the cannulae 2816. The length of the cannulae 2816 may also be
selected
to provide depth control of instruments guided by the cannulae 2816.
The cannulae 2816 may optionally include extensions 2819 of any size or shape.
In one embodiment, the extensions 2819 are positioned proximate to a distal
end of the
cannulae 2816. In another embodiment, the extensions 2819 wrap at least
partially around
the exterior of the cannulae 2816. The extensions 2819 may also project at
least partially
beyond the distal end of the cannulae 2816. The extensions are adapted to wrap
at least
partially around a predetermined portion of the patient's anatomy. In one
embodiment, the
extensions 2819 are adapted to wrap around a portion of one of the pars and
the superior
articular process.
Optionally, the guide 2810 may include one or more legs 2824. The legs may
extend from one or more of the medial body 2812 and the cannulae 2816. The
angle and
orientation of each leg 2824 with respect to the medial body 2812 may be
varied to match
the anatomy of the patient, or to avoid a portion of the patient's anatomy.
In one embodiment, at least a portion of the medial body 2812, the cannula
2816,
and the legs 2824 are configured to contact the patient's anatomy. For
example, patient
specific contact surfaces 2818, 2825 may be formed on one or more of the
cannula 2816,
including the projections 2819, and one or more of the legs 2824,
respectively.
Optionally, at least a portion of the medial body 2812 may be configured to
contact a
44
CA 03001898 2018-04-12
portion of the patient's anatomy. Accordingly, the medial body 2812 may also
optionally
include patient specific contact surfaces 2826.
The contact surfaces 2818, 2825, 2826 may be adapted to fit directly to
aspects of
the patient's anatomy, such as one or more of the medial side of the inferior
articular
process, the lateral sides of the lamina, the spinous process, and the
junction between the
pars and the transverse process, and other anatomical features of the patient.
The patient-
specific contact surfaces 2826 of the medial body 2812 may optionally contact
at least a
portion of the spinous process. The contact surfaces 2818, 2825, 2826 are
determined to
match at least a portion of a curvature of the patient's anatomy to facilitate
placement of
the guide 2810 in a predetermined alignment with respect to a predetermined
portion of
the patient's anatomy during a surgical procedure.
The patient contact surfaces 2818, 2825, 2826 may include any number of
protrusions, depressions, and contours to substantially conform to the
patient's anatomy.
For example, the contact surfaces 2818, 2825, 2826 may comprise multiple
portions that
are adapted to contact two different planes formed by two distinct portions of
the patient's
anatomy. In this manner, the contact surfaces 2818, 2825, 2826 are adapted to
one or more
of: align the guide 2810 in a predetermined position and orientation with
respect to the
patient's anatomy; hook around a portion of the patient's anatomy; prevent
unintended or
inadvertent movement of the guide 2810 during a surgical procedure; and
displace soft
tissue. In one embodiment, the contact surfaces 2818, 2825, 2826 comprise
relatively thin
extensions to displace soft tissue. By protruding at least partially around
and substantially
conforming to different portions of the patient's anatomy, the contact
surfaces 2818, 2825,
2826 generally "hook" at least partially around (or to) the patient's anatomy.
Thus, the
surfaces 2818, 2825, 2826 may contact at least two different planes formed by
distinct
surfaces of the patient's anatomy.
At least one of the cannulae 2816 may include a bore 2820 to guide instruments
and fixation devices. The bore 2820 of each cannulae 2816 can have a unique
internal
diameter that is adapted to receive a particular instrument or fixation
device. The internal
diameter may also be selected to prevent the use of the incorrect instrument
or device with
the guide 2810. The bore diameter and/or the length of the cannulae 2816 may
also
prevent the instrument or device from advancing into the cannulae 2816 beyond
a
predetermined distance, thereby providing a hard stop for depth control.
The bore 2820 may also have a shape adapted to align the tool or fixation
device in
a predetermined orientation of use. Additionally, a protrusion, key, notch, or
void may be
CA 03001898 2018-04-12
formed on the cannulae 2816 or in the bore 2820 to one or more of: prevent the
use of the
incorrect instrument or device; prevent an incorrect orientation of the
correct tool or
device; and prevent over insertion of the tool or device. For example, in one
embodiment
of the present invention, the cannulae bore 2820 may include an instrument
contact
surface that is associated with a feature of the tool, such as a protrusion,
to control the
depth or orientation of insertion of the tool. Thus, the cannulae 2816 may be
adapted to
prevent the instrument or fixation device from advancing too far into the
boney anatomy
of the patient or otherwise being misused.
The guide 2810 may include features adapted to be grasped or manipulated by a
surgeon. Accordingly, gripping features 2829 may be formed on a portion of the
guide
2810. In one embodiment, the gripping features 2829 comprise protrusions. The
protrusions 2829 may be of any shape or size selected to facilitate grasping
of the guide
2810 in a surgical environment. In one embodiment, the protrusions 2829 are
formed on a
portion of the medial body 2812. The protrusions 2829 may comprise ridges or
bumps. In
one embodiment, the protrusions 2829 comprise three generally parallel ridges
formed on
opposing sides of each portion 2812A, 2812B of the medial body 2812. However,
it will
be appreciated than any number of protrusions may be formed with the griping
feature
2829. Optionally, the gripping features 2829 of the medial body portion 2812A
may be
different than the gripping features of medial body portion 2812B. In this
manner, a
surgeon or other user can determine an orientation of the guide 2810 by feel
without being
required to look at the guide. In one embodiment, the gripping features 2829
are formed
on a portion of the guide 2810 that extends beyond the patient's anatomy when
the guide
2810 is in a predetermined position in contact with the patient's anatomy.
Although not illustrated in Fig. 32 the guide 2810 may further comprise
attachment
points formed in one or more of the medial body 2812, the cannulae 2816, and
the legs
2824. The attachment points are adapted to receive one or more secondary 2840
or
tertiary cannulae 2850. The cannulae 2840/2850 may include a bore 2820A or a
cutting
slot to guide an instrument to target another portion of the patient's
anatomy. In one
embodiment, the cannulae 2840, 2850 are adapted to target one or more
predetermined
portions of the cervical spine (i.e., Cl-S1 and ilium).
In one embodiment, the attachment points comprise slots to receive extensions
2842 of the cannulae 2840, 2850. In one embodiment, the slots may also direct
the path of
a blade or other cutting instrument, or to receive a measurement aid or tool
for facilitating
46
CA 03001898 2018-04-12
=
the surgeon/user in identifying landmarks, surrounding boney anatomy,
placement of
implanted devices, or for surgical planning.
The guide 2810 may further comprise slots formed in the medial body 2812 or
the
cannulae 2816. The slots may be the same as or similar to slots 1830. In one
embodiment, the slots are adapted to direct the path of a blade or other
cutting instrument
in a manner similar to cutting slots 20-820 of all embodiments described
herein.
Alternatively, the slots of guide 2810 may be adapted to receive the secondary
2840 or
tertiary cannulae 2850 as further described in conjunction with Fig. 31. In
another
embodiment, the guide 2810 is adapted to receive a cutting guide 10 in a
manner similar to
guide 1810A illustrated in Fig. 25D. The cutting guide 10 may be received by a
slot
formed in one or more of the medial body, cannulae, and legs. Optionally, the
cutting
guide 10 may be integrally formed with the guide 2810.
Referring now to Figs. 33A-33B, another embodiment of a patient-specific guide
2910 of the present invention is illustrated. The guide 2910 is similar to
guide 2810 and
generally includes a medial body 2912 and a cannulae 2916. The cannulae 2916
are the
same as, or similar to, the cannulae 2816 and may include an extension 2919
and a bore
2920. The extensions 2919 are generally expanded radially compared to the
extension
2819 of guide 2810. Accordingly, the extensions 2919 cup around the patient's
anatomy
and the contact surfaces 2918 have a larger surface area than contact surfaces
2818. More
specifically, the increased radial size of the extensions 2919 enable the
contact surfaces
2918 to contact more variable bone surfaces of the patient. In one embodiment,
the
extensions 2919 are adapted to contact at least a portion of one or more of
the patients'
superior articular process and the pars.
The extensions 2919A, 2919B can have similar or different shapes as needed
based
on the patient's anatomy. For example, extension 2919A wraps around a portion
of the
circumference of cannulae 2916A and extension 2919B wraps around the entire
circumference of cannulae 2916B. Additionally, the radius of the extensions
2919 may be
varied. In one embodiment, the radius of extension 2919A is different than
extension
2919B.
The guide 2910 also includes a gripping feature 2929 of another embodiment of
the present invention. The gripping feature 2929 comprises a depression 2930
formed in a
portion of the medial body 2912. One or more protrusions 2932 may be
associated with,
or arranged around, the depression 2930.
47
CA 03001898 2018-04-12
= =
The guide 2910 may also include indicia 2928 to identify a sequence of use or
portions of the patient's anatomy with which the guide 2910 is to be used.
Referring now to Figs. 34A, 34B, another embodiment of a patient specific
guide
3010 of an embodiment of the present invention is illustrated. The guide 3010
is similar to
guides 2810 and 2910 and generally includes a medial body 3012, legs 3024,
cannulae
3016, and gripping features 3029 comprising a depression 3030 and protrusions
3032.
Patient specific contact surfaces 3018, 3025, 3026 may be formed on one or
more of the
cannulae 3016, legs 3024, and medial body 3026 the same as (or similar to)
those on the
guides 2810, 2910.
Each of the cannulae 3016 may include an extension 3019 and a bore 3020. The
bore 3020 is the same as any of the bores 1820, 1920, 2820, 2920 described
herein. The
extensions 3019 are similar to the extensions 2919 and have an expanded radius
compared
to the extensions 2819. However, the extensions 3019 have a different
alignment and
shape compared to the extensions 2919. More specifically, as best seen in Fig.
34B, the
extensions 3019 have contact surfaces 3018 that vary in length axially around
the
circumference of the cannulae 3016.
Additionally, the extensions 3019, cannulae 3016, and the contact surfaces
3018
define a chamber or concavity 3034 proximate to the bore 3020. A concavity
3036 similar
to concavity 3034 may also be formed in the distal end of each leg 3024. The
concavities
3034, 3036 provide a focused contact between the patient specific contact
surfaces 3018,
3025 of the cannulae 3016 and legs 3024 and the patient's anatomy. More
specifically,
without the concavities 3034, 3036, the smooth surfaces of the cannulae 3016
and/or legs
3024 may contact soft tissue of the patient that has not been cleaned from the
bone. This
contact may prevent proper alignment of the guide 3010. Said another way, the
concavities 3034, 3036 prevent the cannulae 3016 and legs 3024 from contacting
soft
tissue that may not have been cleaned off of the bone. Accordingly, the
concavities 3034,
3036 help ensure proper alignment of the guide 3010 with the targeted portion
of the
patient's anatomy.
The concavity 3034 of the cannulae 3016 may also receive and collect bone
material created by a boring instrument, such as a drill bit, guided by the
bore 3020. In
this manner, bone material may exit a hole formed in bone of the patient and
be received
within the concavity 3034. The bone material created during the medical
procedure is thus
collected and does not push the guide 3010 away from the target portion of the
patient's
anatomy, ensuring that the guide 3010 remains in a predetermined orientation.
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Referring now to Figs. 35A ¨ 35C, still another embodiment of a patient
specific
guide 3110 of the present invention is illustrated. The guide 3110 is similar
to guides
2810, 2910, and 3010 and generally includes a medial body 3112, cannulae 3116,
and legs
3124. The cannulae 3116 may include a bore 3120 that is the same as bores
1820, 2820,
2920, or 3020. Extensions 3119 with an increased radius may be formed on each
cannulae
3116 similar to the extensions 2919, 3019 of guides 2910, 3010. Patient
specific contact
surfaces 3118, 3125 may be formed on one or more of the cannulae 3116 and legs
3124 as
described herein in conjunction with guide 2810.
The guide 3110 also includes at least one cutaway or aperture 3138,
illustrated in
Figs. 43A, 43B, through the cannulae 3116. The aperture 3138 intersects at
least a portion
of the bore 3120 and enables bone material to exit the cannula during drilling
of the
patient's bone. As a consequence, the bone material does not collect between
the guide
3110 and the patient's anatomy, such as a vertebrae 4, which may potentially
interfere
with the alignment of the guide 3110.
Although only one aperture 3138 is illustrated on cannula 3116A, apertures
3138
may be formed on each cannulae 3116 of the guide 3110. Additionally, the
apertures 3138
can be formed in different portions of the cannulae 3116 than illustrated in
Fig. 35. The
apertures 3138 may also be formed to have a shape adapted to avoid anatomy of
the
patient, such as an adjacent vertebra. For example, the aperture may have one
or more of
a different length, width, and shape than illustrated in Fig. 35. In this
manner, the
apertures 3138 ensure the guide 3110 is in a predetermined alignment with a
target portion
of the patient's anatomy.
Referring now to Figs. 36A-36F, still more patient specific guides 3210 of an
embodiment of the present invention is illustrated. The guides 3210 generally
includes a
medial body 3212, cannulae 3216, legs 3224, and secondary legs 3242. The
secondary
legs 3242 have contact surfaces 3225A adapted to contact predetermined
portions of the
patient's anatomy. The contact surfaces 3225A are formed in the same manner as
contact
surfaces 2818, 2825 of guide 2810. In one embodiment, the contact surfaces
3225A are
formed using the method of Fig. 2. The contact surfaces 3225, 3225A of the
legs 3224,
3242 are aligned to contact one or more of the lamina, pars, articular
processes, and
spinous process of the patient's anatomy 4. Additionally, the contact surfaces
3325,
3225A may be patient specific as described herein. The contact surfaces 3225,
3225A of
the legs may also include concavities the same as or similar to the concavity
3036 of guide
3010.
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In one embodiment, one or more of the cannulae 3216 have a length selected
such
that distal ends of the cannulae 3216 do not contact the patient's anatomy.
Accordingly,
as illustrated in Figs. 36B, 36C, the distal ends of the cannula 3216 are
separated by a
predetermined distance from a vertebrae 4 of the patient when the guide is
aligned with the
vertebrae 4.
Alternatively, one or more of the cannulae 3216 may have an increased length
such
that the distal end of the cannulae 3216 contacts a predetermined portion of
the patient's
anatomy. Thus, the distal end of the cannulae 3216 may include one or more of
patient-
specific contact surfaces, an extension, a concavity, and an aperture the same
as, or similar
to, contact surfaces 2818, 2918, 3018, 3118, extensions 2819, 2919, 3019,
3119,
concavities 3034, and aperture 3138.
Referring now to Figs. 36D-36F, perspective views of another patient-specific
guide 3210A adapted to be positioned within an incision against a patient's
honey
anatomy are provided. In one embodiment, the guide 3210A is adapted for use in
a
surgical procedure involved a vertebrae 4 of a patient to guide instruments
and fixation
devices along one or more trajectories A, B. However, the guide 3210A may be
used to
guide instruments and for placement of fixation devices in surgical procedures
involving
other boney anatomy of the patient.
The guide 3210A is similar to the guide 3210 described in Figs. 36A-36C.
Accordingly, the guide 3210A generally includes one or more of a medial body
3212, legs
3224, and secondary legs 3242 that are the same as, or similar to, the medial
body, legs,
and secondary legs of guide 3210. Optionally, the guide 3210 may include one
or more
cannulae 3216. The optional cannulae 3216 may further include a bore 3220 for
placement of a temporary fixation pin to temporarily fix the guide 3210A to
the patient's
anatomy 4 during a surgical procedure.
Guide 3210A also includes at least one external cannula 3250 (or "posterior
cannula") associated with at least one internal cannula 3260 (or "anterior
cannula"). Pairs
of associated external and internal cannula 3250, 3260 are substantially
collinearly
aligned. After the guide 3210A is positioned against the patient's anatomy 4
through a
first incision, the internal cannula 3260 is targeted by the surgeon through a
second
incision in the patient's soft tissue. The internal cannula 3260 improves the
mechanical
guidance of instruments into the patient's anatomy 4. In one embodiment, the
external
cannula 3250 are interconnected to a support element 3254. The support element
3254
CA 03001898 2018-04-12
may be of any size. Optionally, the support element 3254 is sized to position
the external
cannula 3250 laterally beyond the width of the guide 3210A.
The external cannula 3250 may optionally be releasably interconnectable to the
medial body 3212. For example, as illustrated in Fig. 36E, the external
cannula 3250 may
include a projection 3256 adapted to be received within a corresponding slot
3213 formed
in the guide 3210A. In one embodiment, the slot 3213 is formed in the medial
body 3212
and is the same as (or similar to) one of the slots 1830 of guide 1810.
The internal cannula 3260 are interconnected to a portion of the guide 3210A
to be
positioned within an incision through the patient's skin S. In one embodiment
the internal
cannula 3260 are interconnected to a distal portion of the cannula 3216.
However, the
internal cannula 3260 may optionally be interconnected to other portions of
the guide
3210A including the legs 3224 and/or the secondary legs 3242.
The external cannula 3250 include bores 3252 that are generally concentrically
aligned with bores 3262 of the corresponding internal cannula 3260.
Accordingly, in
combination, corresponding pairs of external and internal cannula 3250, 3260
define a
virtual cannula of an extended length. However, by using a pair of
corresponding external
and internal cannula 3250, 3260, the size of an incision required to position
the guide
3210A may be decreased compared to an incision required for a guide with a
cannula of a
length extending from the external cannula 3250 to the internal cannula 3260.
Further, by
positioning the internal cannula 3260 on a distal portion of the guide 3210A
proximate to
the patient's anatomy, the center of gravity of the guide 3210A is moved
closer to the
patient's anatomy 4. Thus, the guide 3210A is docked low and stably on the
patient's
bone 4. improving the accuracy of k-wires and other instruments guided along
trajectories
A, B.
The internal cannula 3260 further include an aperture 3264. The aperture 3264
forms a channel from the bore 3262 to an exterior of the internal cannula
3260. The
aperture 3264 is sized to allow a k-wire to pass through the aperture 3264
such that the
guide 3210A may be removed from the patient after a k-wire oriented by the
guide 3210A
is positioned within the patient's anatomy. In one embodiment, the aperture
3264
comprises a slot that extends longitudinally from an exterior surface of the
cannula 3260
to the bore 3262. As illustrated in one embodiment in Fig. 36F, when an
instrument, such
as a sleeve 1854 is received at least partially in the bore 3262, the aperture
3264 is
obstructed such that a k-wire or other instrument positioned within a bore
1856 of the
sleeve 1854 is retained within the bore 3262 of the internal cannula 3260B.
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CA 03001898 2018-04-12
Referring now to Figs. 37A-37D, another patient specific guide 3310 of the
present
invention is illustrated. In one embodiment, the guide 3310 is adapted to be
positioned
proximate to a patient's ilium 8, as indicated by indicia 3328 that indicate a
direction
toward the sacral vertebrae Si and S2.
The guide 3310 is similar to guide 3210 and generally comprises a medial body
3312, cannulae 3316 including bores 3320, legs 3324, and secondary legs 3342.
The legs
3324, 3342 may each include patient specific contact surfaces the same as, or
similar to,
the contact surfaces 3225, 3225A. In one embodiment, distal ends of the
cannulae 3316
do not contact the patient's anatomy. Alternatively, one or more of the
cannulae 3316
may include patient specific contact surfaces similar to the contact surfaces
2818 of guide
2810.
The guide also includes secondary cannulae 3340. Each secondary cannulae
3340A, 3340B may have a unique trajectory to target portions of the patient's
anatomy.
The secondary cannulae 3340 are similar to cannulae 3316 and have a
predetermined
length and orientation with respect to the guide 3310. The cannulae 3340
include bores
3320A that are formed in a manner similar to bores 1820, 2820, 3320.
Accordingly, the
bore 3320A of each secondary cannulae 3340 may be used to guide instruments to
another
targeted portion of the patient's anatomy.
In one embodiment, the secondary cannulae 3340 are oriented to guide an
instrument in an S2-alar or an S2-alar-iliac trajectory. In one embodiment,
the bores
3320A of the secondary cannulae 3340 are oriented to guide a drill bit to form
a pilot hole
in the S2-alar or an S2-alar-iliac trajectory.
The secondary cannulae 3340 are spaced from the guide 3310 by support elements
3341 of a predetermined length. In one embodiment the support elements 3341
are
interconnected to the cannulae 3316. However, the support elements 3341 may be
interconnected to other portions of the guide 3310, such as the medial body
3312 and/or
the legs 3324. Optionally, the secondary cannulae 3340 may be releasably
interconnected
to the guide 3310. Accordingly, the secondary cannulae 3340 can be added to,
or removed
from, the guide 3310 during a surgical procedure. Further, the secondary
cannulae 3340A,
3340B may be used to perform a first procedure on the patient's anatomy and
then
replaced by subsequent secondary cannulae 3340 that are used to perform
additional
procedures. In another embodiment, the secondary cannulae 3340 may be
integrally
formed with the guide 3310.
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CA 03001898 2018-04-12
Referring now to Figs. 38-45, a patient-matched interbody guide 3410 is
described.
The guide 3410 is adapted for the placement of one or more interbody devices,
such as an
implantable cage for introducing one or more bioactive substances or bone
graft material,
or an artificial disc. Optionally, the guide 3410 may be used to arrange one
or more tools
used in the procedure. The guide 3410 is adapted to be inserted between two
adjacent
vertebral bodies and to distract two or more anatomical features. For example,
an anterior,
posterior, posterior lateral, or direct lateral approach to the disc space may
be achieved
with the guide 3410 to facilitate placement of implants in oblique, direct
lateral, or
posterior approaches.
In one embodiment, the interbody guide 3410 is designed following acquisition
of
a scan of the patient's anatomy with a medical imaging device. The scan is
segmented
into 3D models of each vertebra. These 3D models are then modified in CAD to
simulate
the correction desired by the surgeon. Once the desired correction is
appropriately
simulated, a guide 3410 is generated that will allow the surgeon to make the
planned
corrections intraoperatively. The guides may then be manufactured through 3D
printing,
rapid prototyping, or an alternative method as described herein.
The guide 3410 may take on other shapes, orientations, thicknesses, etc.
without
deviating from the novel aspects of this disclosure. Similarly, guide 3410 may
be of any
size and may comprise extensions or handles to aid in grasping or manipulating
the guide
3410 as desired.
Referring now to Fig. 38, the patient-matched guide 3410 is shown in an
exploded
view to demonstrate how a plurality of components may be fabricated using the
system
and method described above for a particular surgical procedure. The components
of the
guide 3410 generally include a patient-specific insert 3412, a guide sleeve
3414, and
connectors 3416, which, in a finally assembled state, form the patient-matched
guide 3410
shown in Figure 50.
Referring now to Figs. 38-39, the insert 3412 generally comprises a proximal
surface 3418, a distal surface 3420, two projections 3422, 3424 extending from
the distal
surface, an aperture 3426, and bores 3428. The projections 3422, 3424 are
adapted to fit
.. directly to aspects of a patient's anatomy. More specifically, the
projections 3422, 3424
are adapted to be positioned between a superior vertebrae and an inferior
vertebrae within
the intervertebral disc space. The shape of the projections 3422, 3424 is
predetermined to
match at least a portion of a curvature of the adjacent vertebrae and to
facilitate the
insertion of an implant with a predetermined size and shape into the
intervertebral space.
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CA 03001898 2018-04-12
The projections include a variety of patient-contacting surfaces which permit
the
insert 3412 to mate with portions of one or more vertebral bodies. For
example, the upper
surfaces 3430, 3432, lower surfaces 3434, 3436, and interior surfaces 3438,
3440 of the
respective projections 3422, 3424 may include patient specific contact
surfaces. The distal
surfaces 3420 of the insert 3412 may also include patient specific contact
surfaces.
The patient specific surfaces are adapted to one or more of: align the insert
3412
in a predetermined position with respect to the patient's anatomy; hook around
a portion
of the patient's anatomy; prevent unintended or inadvertent movement of the
insert 3412
during a surgical procedure; and displace soft tissue. In one embodiment, the
patient
specific surfaces comprise relatively thin extensions to displace soft tissue.
In one embodiment, the insert 3412, or portions thereof, may be manufactured
from a material that is at least partially flexible or deformable. In another
embodiment,
the insert 3412 is manufactured from a material with shape memory, such as
Nitinol.
Additionally, or alternatively, the projections 3422, 3424 may be
asymmetrical.
Thus, in one embodiment, one projection has a shape and/or size that is
different than the
other projection. Additionally, the angle and orientation of each projection
with respect to
the distal surface 3420 of the insert 3412 can be varied to match the anatomy
of the
patient, or to avoid a portion of the patient's anatomy. In one embodiment,
the shape of
the projections 3422, 3424 does not provide correction of deformities of the
patient's
anatomy. In another embodiment, the shape of the projections provides at least
some
correction of the patient's deformity.
Portions of the projections may have a tapered shape that can be used to
distract
the vertebrae. For example, the distal portion 3442, 3444 of each projection
3422, 3424
may comprise a full-radius or bullet-shaped nose for ease of insertion.
Additionally, or
alternatively, the distal portions may have a wedge shape.
The upper surfaces 3430, 3432 of the projections 3422, 3424 may not be
parallel to
the lower surfaces 3434, 3436. Further, the upper and lower surfaces may have
different
shapes. For example, and referring now to Fig. 39, the projections may taper
as they
extend distally away from the distal surface 3420 of the insert 3412.
Optionally, a distal
.. portion of the projection 3422 may have a first thickness 3446
substantially equal to, or
slightly greater than, a thickness of an implant. A proximal portion of the
projection 3422
may have a second thickness 3448 that is greater than the first thickness 3446
and greater
than the thickness of the implant. In this manner, a surgeon may "over
distract" the
adjacent vertebrae. The over distraction facilitates easier and safer access
to the
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CA 03001898 2018-04-12
intervertebral space, placement of the implant, and generates lordosis or
other planned
correction of the patient's anatomy.
The projections 3422, 3424 may also be adapted to prevent a user from
advancing
the insert 3412 into the intervertebral space beyond a predetermined distance.
For
example, a protrusion or notch may be formed on a portion of at least one of
the
projections 3422, 3424 to provide a hard stop. Alternatively, a protrusion or
notch may be
formed on the projections or some other portion of the insert 3412, such as
the distal
surface 3420, to prevent an incorrect orientation of the guide 3410. The
stops, protrusions,
or notches may be specific to the patient's anatomy and allow for protection
of neural
elements or other features of the patient's anatomy.
The guide 3410 and the insert 3412 may further comprise one or more indicia
for
identifying the guide for a particular patient, a level of the patient's
spine, or other indicia
indicating the direction, orientation, use, or purpose of the guide.
Additionally, or
alternatively, the projections 3422, 3424 and other portions of the interbody
guide 3410
may include means to indicate a relative position of the projections 3422,
3424 into the
intervertebral space as the insert 3412 is advanced or withdrawn. The means to
indicate
may be the same or different for each of the projections.
A manual or mechanical impact force may be applied to the insert 3412 to
advance
the projections 3422, 3424 between the adjacent vertebrae. Accordingly, in one
embodiment of the present invention, the insert 3412 is made of a sufficiently
rigid and
durable material to receive an impact force from a hammer or other impact
device.
Although illustrated with a generally oval shape, one of skill in the art will
appreciate that the aperture 3426 may have any desired shape, including an
asymmetrical
shape. For example, the aperture 3426 may be shaped to receive a curved or
asymmetric
implant. Optionally, slots or protrusions may be formed on a sidewall 3450 of
the aperture
to ensure the implant is inserted in a predetermined orientation.
Additionally, the size or
shape of the aperture 3426 may be designed to achieve greater visibility to
the
surgeon/user, or to facilitate placement of one or more instruments or other
devices into
the intervertebral space.
Notches 3452 may be formed in the aperture 3426 that align with keys 3454 of
the
guide sleeve 3414. The interaction of the notches 3452 and keys 3454 may
ensure the
guide sleeve 3414 is properly aligned with the aperture 3426. The guide sleeve
may
include an aperture 3456 to guide instruments and/or implants inserted into
the
intervertebral space to a planned depth and orientation. It will be
appreciated that the
CA 03001898 2018-04-12
guide sleeve aperture 3456 may have a different size and shape than the insert
aperture
3426. Additionally, or alternatively, the aperture 3456 may also include slots
or
protrusions to ensure implants or instruments are inserted in the
predetermined orientation.
The guide sleeve 3414 may have any size and shape selected to be at least
partially
received in the insert aperture 3426. Further, the guide sleeve 3414 may
project at least
partially from the proximal surface 3418 of the insert 3412. Optionally, a
proximal
portion of the guide sleeve 3414 may project at least partially beyond an
incision and the
patient's skin during the surgical procedure. The guide sleeve 3414 may be
formed of any
material. Optionally, the material of the guide sleeve may the same as, or
different from,
the material of the insert 3412. In one embodiment, the guide sleeve is formed
of a
material that is of sufficient strength that breaking and/or flaking of the
sleeve material is
avoided. Accordingly, the guide sleeve may withstand the effects of high-speed
cutting
tools without damage and without permitting material from the guide sleeve to
become
deposited in the intervertebral space.
Any number of different guide sleeves 3414 ... 3414N may be releasably
received
in the insert aperture 3426 for use with the interbody guide 3410. Each guide
sleeve 3414
may be adapted to guide a different insert or tool during a surgical
procedure. For
example, a first guide sleeve may be introduced into the insert aperture 3426
to guide a
first tool or insert. The first guide sleeve may then be replaced by a second
guide sleeve
introduced into the insert aperture. The second guide sleeve may guide a
second tool or
insert. The second tool or insert may have a different size, shape, or purpose
than the first
tool or insert.
Referring now to Fig. 40, an embodiment of a guide sleeve 3414A with a guide
slot 3458 is illustrated in a position of use in the insert aperture 26. The
guide slot 3458
has a size and orientation selected to direct the path of an implant, a blade,
cutting tool, or
other instrument. In one embodiment, the guide slot 3458 is the same as, or
similar to, and
includes features of any of the slots 20, 120, 320. 420, 520, 720, 820
described herein.
Some implants, such as motion preserving and disc replacement implants,
include fins or
other surfaces that extend into the end plates of adjacent levels of the
patient's spine. For
proper placement of these implants the surgeon must remove portions of the
bone from
each adjacent level of the spine. Accordingly, the slot 3458 can have any
shape
determined to guide cuts for a planned removal of a portion of each of the
adjacent
vertebrae of the particular patient. For example, the slot may have a shape to
guide
instruments to provide straight, concave, convex, or other shaped cuts.
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CA 03001898 2018-04-12
The slot 3458 may be sized or shaped to receive a particular cutting tool,
prevent
inappropriate use of the particular cutting tool, and prevent the use of an
inappropriate
tool. Additionally, the slot may be shaped to guide a cut around a neural
element of the
patient or to prevent a cut into a neural element. Accordingly, the slot 3458
can be used to
guide instruments along a presurgically planned pathway while controlling
instrument
orientation and depth. Further, the width of the slot may change to control
the size of a
cutting tool that fits through the slot, or tit into different portions of the
slot. By using the
slot 3458 of guide sleeve 3414A inserted into the insert aperture 3426, a
surgeon may
confirm positioning and alignment of the cutting trajectory and path prior to
initiating the
to procedure.
Stops may be formed in the slot 3458 to limit or control the depth of
insertion of
the cutting tool. The stops may be specific to the patient's anatomy and allow
for
protection of neural elements of the patient or to prevent unintended removal
of portions
of the vertebrae. The slot 3458 may also be keyed to ensure depth control
while cutting.
For example, the slot may include a key that alters the depth of cutting by
the tool as the
tool is guided through the slot. The key may correspond to a feature, such as
a protrusion,
on the tool that limits the depth of insertion of the tool.
The slot 3458 of guide sleeve 3414A may be adapted to receive different types
and
sizes of tools or implants. Additionally, or alternatively, the guide sleeve
3414A may be
operable to receive only one particular tool or implant.
Additionally, or alternatively, and referring now to Fig. 41, a guide sleeve
3414B
of another embodiment may include a guide surface 3460 formed on a sidewall of
the
aperture 3456B. The guide surface 3460 has a predetermined angle to guide
instruments
or implants during the surgical procedure. For example, the surface 3460 may
guide an
instrument for disc space preparation. Additionally, the surface 3460 may be
shaped to
guide an implant, such as, but not limited to, a motion sparing implant, an
interbody fusion
device, a plate, for oblique insertion angles. The guide sleeve 3414B may also
include a
guide surface with a defined track according to a planned oblique access angle
to facilitate
insertion and alignment of an implant. It will be appreciated that the guide
surface 3460
may be formed on any portion of the aperture 3456B of the guide sleeve 3414B.
Different guide sleeves 3414, 3414A, 3414B ... 3414N can be provided with
features to ensure operations are performed in a preplanned sequence. In one
embodiment, guide sleeves 3414, 3414A ... 3414N are formed to interconnect
together in a
planned sequence. Accordingly, a first procedure may be performed with sleeve
3414 and
57
CA 03001898 2018-04-12
insert 3412. Sleeve 3414A may then be interconnected to sleeve 3414 and insert
3412 for
use during a second procedure. Sleeve 3414B may then be interconnected to
sleeve
3414A, 3414 and insert 3412 for use during a third procedure. In this manner,
sleeves
3414 may be used sequentially without removing previous sleeves from the
insert 3412.
This may be beneficial, for example, when a sleeve 3414 is holding an
instrument, such as
a pin. The instrument will not require adjustment when a subsequent sleeve
3414A is
added to the insert 3412.
The bores 3428 of the insert 3412 may also be patient specific. Accordingly,
the
size, location, and trajectory of the bores 3428 may be determined based on
the patient's
to anatomy. Further, the trajectory of each bore may be selected to target,
or avoid, a
specific portion of the patient's anatomy. Accordingly, each of the bores may
have a
different shape, width, depth, and orientation adapted to guide a specific
instrument or
fixture in a specific orientation. Although three bores are illustrated, it
will be appreciated
that any number of bores may be formed in the insert, including no bores. The
bores can
receive a connector or fixture 3416, such as a pedicle screw, to temporarily
fix the guide
3410 to the patient's spine. Placing a fixture through the bores 3428 can
increase stability
of the guide 3410 during use.
Optionally, the bores 3428 may be adapted to receive a tool, such as a tool
for
forming a bore in the patient's anatomy. Accordingly, each bore 28 may have a
length,
shape, protrusion, and/or a diameter selected to prevent the use of the
improper tool or
device, prevent improper use of a predetermined tool or device, and ensure
proper use of
the predetermined tool or device.
Additionally, the bores 3428 may be used to deliver graft material into the
intervertebral space. For example, in one embodiment, the bores are operable
to conduct
bone graft material and other substances from a surgical tool, such as a
syringe, to a
predetermined portion of the intervertebral space.
Referring now to Figs. 42-43, the patient-matched guide 3410 is shown in one
potential location of use relative to a unique anatomical grouping for
assisting the surgeon
for placing one or more interbody devices. More specifically, Fig. 42
illustrates the guide
3410 between superior VS and inferior VI adjacent vertebrae. The inferior
vertebrae is not
illustrated in Fig. 43 for clarity. Figs. 44A, 44B illustrate the guide 3410
of Fig. 42 with a
different guide sleeve 3414A including guide slot 3458 inserted in the
aperture of the
insert 3412.
58
CA 03001898 2018-04-12
Guides 3410 of the present disclosure may be adapted for use between any two
adjacent vertebrae. For example, and referring now to Fig. 45, a guide 3410A
of another
embodiment is illustrated between two different vertebrae VS, VI. The guide
includes
insert 3412A that includes a first projection 3422A and a second projection
(not
illustrated) similar to projection 3424 that include patient specific contact
surfaces adapted
to contact the two vertebrae VS, VI illustrated in Fig. 45. However, the first
and second
projections of insert 3412A have a different size or shape compared to the
projections of
insert 3412. Additionally, or alternatively, the insert aperture 3426A of
guide 3410A may
have a size or shape that is different than the size and shape of the aperture
3426 of guide
3410. In this manner, guide sleeves 3414A ... 3414N adapted for use in a
procedure with
guide 3410 may not fit, and thus cannot be misused, with guide 3410A.
Optionally, the
insert aperture 3426A may have the same size and shape as aperture 3426.
It is expressly understood that other shapes for the interbody guide 3410 and
its
components are equally practical and considered within the scope of the
disclosure.
Additionally, or alternatively, at least a portion of the proximal end of the
guide may be
configured to extend outside of the patient during a surgical procedure.
The foregoing discussion of the disclosure has been presented for purposes of
illustration and description. The foregoing is not intended to limit the
disclosure to the
form or forms disclosed herein.
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