U.S. patent application number 14/883299 was filed with the patent office on 2017-05-18 for patient-matched apparatus and methods for performing surgical procedures.
This patent application is currently assigned to MIGHTY OAK MIEDICAL INC.. The applicant listed for this patent is MIGHTY OAK MIEDICAL INC.. Invention is credited to George Frey, Paul Ginzburg, Geoff Lai, Caleb Voelkel.
Application Number | 20170135707 14/883299 |
Document ID | / |
Family ID | 55181101 |
Filed Date | 2017-05-18 |
United States Patent
Application |
20170135707 |
Kind Code |
A9 |
Frey; George ; et
al. |
May 18, 2017 |
Patient-Matched Apparatus and Methods for Performing Surgical
Procedures
Abstract
A system and method for developing customized apparatus for use
in one or more surgical procedures is disclosed. The system and
method incorporates a patient's unique anatomical features or
morphology, which may be derived from capturing MRI data or CT
data, to fabricate at least one custom apparatus. According to a
preferred embodiment, the customized apparatus comprises a
plurality of complementary surfaces based on a plurality of data
points from the MRI or CT data. Thus, each apparatus may be matched
in duplicate and oriented around the patient's own anatomy, and may
further provide any desired axial alignments or insertional
trajectories. In an alternate embodiment, the apparatus may further
be aligned and/or matched with at least one other apparatus used
during the surgical procedure.
Inventors: |
Frey; George; (Englewood,
CO) ; Ginzburg; Paul; (Centennnial, CO) ; Lai;
Geoff; (Lakewood, CO) ; Voelkel; Caleb;
(Lakewood, CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MIGHTY OAK MIEDICAL INC. |
Englewood |
CO |
US |
|
|
Assignee: |
MIGHTY OAK MIEDICAL INC.
Englewood
CO
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20160030067 A1 |
February 4, 2016 |
|
|
Family ID: |
55181101 |
Appl. No.: |
14/883299 |
Filed: |
October 14, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14298634 |
Jun 6, 2014 |
9198678 |
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14883299 |
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13841069 |
Mar 15, 2013 |
8870889 |
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14298634 |
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13172683 |
Jun 29, 2011 |
8758357 |
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13841069 |
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62162466 |
May 15, 2015 |
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61832583 |
Jun 7, 2013 |
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61845463 |
Jul 12, 2013 |
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61877837 |
Sep 13, 2013 |
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61359710 |
Jun 29, 2010 |
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61393695 |
Oct 15, 2010 |
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61625559 |
Apr 17, 2012 |
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61359710 |
Jun 29, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 50/33 20160201;
A61B 2090/061 20160201; A61B 17/1671 20130101; A61B 17/15 20130101;
A61F 2002/4687 20130101; A61B 90/10 20160201; A61B 34/10 20160201;
A61B 17/7074 20130101; A61B 17/7067 20130101; A61B 2050/3008
20160201; A61F 2/4405 20130101; A61B 17/8863 20130101; A61B 17/7047
20130101; A61F 2310/00047 20130101; A61B 17/151 20130101; A61B
17/1757 20130101; A61B 2017/568 20130101; A61B 2090/067 20160201;
A61B 2034/107 20160201; A61F 2310/00029 20130101; A61F 2310/00023
20130101; A61F 2/4611 20130101; A61B 17/7043 20130101; A61F
2310/00017 20130101; A61B 17/7013 20130101; A61B 17/70 20130101;
A61B 2017/00526 20130101; G09B 23/30 20130101; A61B 2034/108
20160201; A61F 2002/30948 20130101; A61F 2/30965 20130101; A61F
2310/00059 20130101; A61F 2002/30952 20130101 |
International
Class: |
A61B 17/17 20060101
A61B017/17; A61B 17/70 20060101 A61B017/70; A61B 19/00 20060101
A61B019/00 |
Claims
1. A patient-specific guide for use in a surgical procedure,
comprising: a medial body having a proximal portion and a distal
portion; a first cannula and a second cannula, each of the cannulae
with proximal and distal portions, at least one of the first
cannula and the second cannula further comprising a bore oriented
in a direction determined from the anatomical features of a
patient, the bore adapted to guide an instrument or a fixation
device in a cortical bone trajectory; and a surface of one or more
of the medial body, the first cannula, and the second cannula
including patient-specific contours determined from the patient's
anatomy and configured to contact and substantially conform to at
least a first subcutaneous anatomic feature of a vertebra of the
patient.
2. The patient-specific guide of claim 1, further comprising a leg
extending from at least one of the first and second cannulae, the
leg including a second surface including patient-specific contours
determined from the patient's anatomy and configured to contact and
substantially conform to a second anatomic feature of the
patient.
3. The patient-specific guide of claim 1, further comprising at
least one leg extending from the medial body, the at least one leg
including a second surface including patient-specific contours
determined from the patient's anatomy and configured to contact and
substantially conform to a second anatomic feature of the
patient.
4. The patient-specific guide of claim 1, wherein the surface with
the patient-specific contours is adapted 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.
5. The patient-specific guide of claim 1, wherein the medial body
comprises a first portion releasably interconnected to a second
portion.
6. The patient-specific guide of claim 1, further comprising at
least a third cannula having a bore that is oriented in a direction
determined from the anatomical features of the patient, the bore
adapted to guide an instrument or a fixation device.
7. The patient-specific guide of claim 6, wherein the direction of
the bore of the third cannula is not parallel to the bore of the at
least one of the first and second cannula.
8. The patient-specific guide of claim 6, wherein the third cannula
is releasably interconnected to the guide.
9. The patient-specific guide of claim 1, further comprising a
cutting guide interconnected to a portion of the guide, the cutting
guide including a track having patient-specific depth control,
angle, and orientation adapted to guide an instrument operable to
remove a predetermined portion of the vertebrae.
10. A patient-specific guide for use in a surgical procedure, the
guide adapted to contact a predetermined portion of a vertebra of a
patient, comprising: a body with a proximal portion and a distal
portion, the body having at least one of a bore and a track
oriented in a predetermined trajectory determined from anatomical
features of the patient, the bore or track adapted to guide an
instrument or a fixation device; and at least two legs extending
from the body, a portion of each leg comprising patient-specific
contours determined from the patient's anatomy and configured to
contact and substantially conform to at least a first subcutaneous
anatomic feature of the vertebra of the patient.
11. The patient-specific guide of claim 10, wherein at least a
portion of one of the legs is adapted to hook at least partially
around, and substantially conform to, a second anatomic feature of
the patient.
12. The patient-specific guide of claim 10, wherein the bore is
directed in one of a cortical bone trajectory and a pedicle screw
trajectory.
13. The patient-specific guide of claim 10, further comprising a
frame, the frame configured to be fixed to screws placed in at
least one vertebrae of the patient, wherein the body of the guide
is adapted to interconnect to the frame.
14. The patient-specific guide of claim 10, wherein the track has
patient-specific depth control, angle, and orientation adapted to
guide an instrument operable to remove a predetermined portion of
the vertebrae.
15. The patient-specific guide of claim 14, further comprising a
second track formed in the body.
16. The patient-specific guide of claim 10, the body further
comprising a second bore that is oriented in a direction for
placement of a temporary fixation device.
17. A patient-specific positioning template for use in a surgical
procedure, comprising: a body having a proximal portion and a
distal portion, the distal portion shaped to substantially conform
to a predetermined portion of a vertebrae of a patient, the body
having at least one of a bore and a track oriented in a direction
determined from anatomical features of the patient, the bore or
track adapted to guide an instrument or a fixation device; and an
extension of the distal portion of the body configured to hook at
least partially around, and substantially conform to, at least a
second predetermined portion of the vertebrae of the patient.
18. The patient-specific positioning template of claim 17, wherein
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.
19. The patient-specific positioning template of claim 17, wherein
the bore is directed in one of a cortical bone trajectory and a
pedicle screw trajectory.
20. The patient-specific positioning template of claim 17, wherein
the track has patient-specific depth control, angle, and
orientation adapted to guide an instrument operable to remove a
predetermined portion of the vertebrae.
21. The patient-specific positioning template of claim 20, further
comprising a second track formed in the body.
22. The patient-specific positioning template of claim 17, further
comprising a cannula with a second bore that is oriented in a
direction for placement of a temporary fixation device.
23. The patient-specific positioning template of claim 17, wherein
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.
24. The patient-specific positioning template of claim 17, further
comprising a frame, the frame configured to be fixed to screws
placed in at least one vertebrae of the patient, wherein the body
of the template is adapted to interconnect to the frame.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent
application Ser. No. 14/298,634, filed Jun. 6, 2014 and claims
priority under 35 U.S.C. .sctn.119(e) to U.S. Provisional
Application Ser. No. 62/162,466, filed May 15, 2015. U.S. patent
application Ser. No. 14/298,634 claims the priority to U.S.
Provisional Patent Application Nos. 61/832,583 filed Jun. 7, 2013,
61/845,463 filed Jul. 12, 2013 and 61/877,837 filed Sep. 13, 2013
and is a continuation-in-part of U.S. patent application Ser. No.
13/841,069, filed Mar. 15, 2013, which claims the priority to U.S.
Provisional Patent Application Nos. 61/359,710 filed Jun. 29, 2010,
61/393,695 filed Oct. 15, 2010, and 61/625,559 filed Apr. 17, 2012.
U.S. patent application Ser. No. 13/841,069 is a continuation in
part of U.S. patent application Ser. No. 13/172,683, filed Jun. 29,
2011, which issued as U.S. Pat. No. 8,758,357 on Jun. 24, 2014.
U.S. patent application Ser. No. 13/172,683 claims priority to U.S.
Provisional Patent Application No. 61/359,710, filed Jun. 29, 2010.
These applications are all incorporated by reference herein in
their entireties.
FIELD OF THE INVENTION
[0002] 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
[0003] 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 boney landmarks due to previous
surgery or when the patient's anatomy is irregular in shape.
[0004] 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.
[0005] The prior art fails to teach a system for creating a suite
of surgical apparatus based on the data set derived from the MRI or
CT scan. For example, the use of the patient-specific data set for
a vertebral body may allow a surgeon to accommodate for subtle
variations in the position and orientation of a plate or other bone
anchor to avoid particular boney anatomy or irregularities in the
positioning and alignment of the adjoining vertebral bodies. As
another example, the use of these data sets may also assist a
surgeon in selecting a desired trajectory for an implantable device
so as to avoid, for example, crossing the pedicle wall and
violating the spinal canal during an actual procedure. The use of
the data sets permit the surgeon to avoid these types of mistakes
by creating customized tools and instruments, which may comprise
orientation, end-stops or other safety related features to avoid
over-torque and over-insertion of any implantable devices. The data
sets also permit the surgeon to create a patient-contacting surface
that is oriented to match one or more of the anatomical features
represented by the data set, and thereby quickly and efficiently
locate and place the patient-contacting surface(s) in the
appropriate location and orientation.
[0006] 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 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
[0007] 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, such as the software disclosed in WO
2008027549, which is incorporated by reference herein in its
entirety), and according to one embodiment described herein, other
apparatus used during the surgical procedure.
[0008] By way of providing additional background, context, and to
further satisfy the written description requirements of 35 U.S.C.
.sctn.112, the following are incorporated by reference in their
entireties for the express purpose of explaining and further
describing the various tools and other apparatus commonly
associated therewith surgical procedures, including minimally
invasive surgery ("MIS") procedures: U.S. Pat. No. 6,309,395 to
Smith et al.; U.S. Pat. No. 6,142,998 to Smith et al.; U.S. Pat.
No. 7,014,640 to Kemppanien et al.; U.S. Pat. No. 7,406,775 to
Funk, et al.; U.S. Pat. No. 7,387,643 to Michelson; U.S. Pat. No.
7,341,590 to Ferree; U.S. Pat. No. 7,288,093 to Michelson; U.S.
Pat. No. 7,207,992 to Ritland; U.S. Pat. No. 7,077,864 Byrd III, et
al.; U.S. Pat. No. 7,025,769 to Ferree; U.S. Pat. No. 6,719,795 to
Cornwall, et al.; U.S. Pat. No. 6,364,880 to Michelson; U.S. Pat.
No. 6,328,738 to Suddaby; U.S. Pat. No. 6,290,724 to Marino; U.S.
Pat. No. 6,113,602 to Sand; U.S. Pat. No. 6,030,401 to Marino; U.S.
Pat. No. 5,865,846 to Bryan, et al.; U.S. Pat. No. 5,569,246 to
Ojima, et al.; U.S. Pat. No. 5,527,312 to Ray; and U.S. Pat. Appl.
No. 2008/0255564 to Michelson.
[0009] Various surgical procedures may be performed through
introduction of rods or plates, screws or other devices into
adjacent boney anatomy to join various portions of, for example, a
vertebra to a corresponding portion on an adjacent vertebra.
Surgical procedures are often performed in the sacroiliac, lumbar,
thoracic, interbody, or cervical spine regions of a patient. The
procedures performed in these areas are often designed to stop
and/or eliminate all motion in the spinal segment by destruction of
some or all of the joints in that segment and further utilizing
bone graft material and/or rigid implantable fixation devices for
securing the adjacent vertebrae. By eliminating movement, back pain
and further degenerative disc disease may be reduced or avoided.
Fusion requires tools for accessing the vertebrae, such as surgical
cannulae for the procedures, and other tools for implanting the
desired implant, bioactive material, etc. Such procedures often
require introduction of additional tools to prepare a site for
implantation. These tools may include drills, drill guides,
debridement tools, irrigation devices, vises, clamps, cannula, and
other insertion/retraction tools.
[0010] Spinal and other surgeries may be performed by a number of
different procedures, as opposed to conventional surgical
procedures and methods, which typically require cutting of muscles,
removal of bone, and retraction of other natural elements. During a
MIS procedure, including procedures using the apparatus of the
present invention, a less destructive approach to the patient
anatomy is carried out by using retractor tubes or portals, which
take advantage of anatomy and current technology to limit the
damage to intervening structures.
[0011] In a typical surgical procedure on the spine, skeletal
landmarks are established fluoroscopically and a small incision is
made over the landmark(s). According to various methods known in
the prior art, a series of dilators are applied until one or more
cannula is placed over the anatomic structure. In some procedures,
a microscope is then placed over the operative site to provide
illumination and magnification with a three dimensional view of the
anatomical site to ensure that the surgeon is able to accurately
locate the desired patient anatomy and properly position and orient
any tool, instrument or other surgical device used during the
procedure. The microscope, however. is an expensive and unwieldy
device requiring uncomfortable gyrations of the surgeon's back and
neck in order to gain the necessary view, and is also a nuisance to
drape (a large, sterile plastic bag has to be placed over the eight
foot tall structure). The use of adequate illumination is also
difficult to direct due to the size of the microscope.
[0012] A significant danger of performing operations on the spine,
and in particular accessing an intervertebral space during a MIS
surgery on the spine, is that of inadvertently contacting or
damaging the para-spinal nerves, including the exiting nerve roots,
traversing nerves and the nerves of the cauda equina. The exact
location of these para-spinal nerves cannot be precisely determined
prior to the commencement of surgery, and therefore are dependent
on a surgeon's ability to visually locate the same after the
initial incision is made. Moreover, intervertebral spaces in the
spine have other sensitive nerves disposed at locations which are
not entirely predictable prior to insertion of the surgical tool
into the intervertebral area. Accordingly, the danger of pinching
or damaging spinal nerves when accessing an intervertebral space
has proven to be quite limiting to the methods and devices used
during minimally invasive spinal surgery. In addition, as cannula
are received through the patient's back, such as when performing
minimally invasive spinal surgery, minor blood vessels are
ruptured, thereby blocking the surgeon's vision inside the
intervertebral region after the cannula has been inserted. Other
anatomical features at a particular patient may also obstruct the
surgeon's view or make it difficult to provide illumination within
the cannula. Therefore, one particular shortcoming that is
addressed by the present disclosure is to provide devices which are
patient-matched to facilitate proper location and orientation
without use of microscopes or other equipment and that otherwise
eliminate the problems associated with prior art procedures on the
spine, including MIS procedures.
[0013] The customized and integrated matching aspects of this
presently disclosed system provides an advantage over the prior
art, in particular by providing a plurality of interlocking and/or
matching points for each apparatus, which in turn reduces the
likelihood of misalignment, misplacement and subsequent mistake
during the surgical procedure(s).
[0014] Accordingly, one aspect of the present disclosure is to
provide a method for preparing a customized surgical device or
instrument, which in a preferred embodiment comprises, but is not
limited to: (1) obtaining data associated with a patient's anatomy;
(2) converting the data obtained to a 3-dimensional data set(s);
(3) determining at least one trajectory or path for facilitating a
surgical procedure to be performed on the patient; (4) determining
at least one surface associated with the patient's anatomy; (5)
generating a 3-dimensional representation of the customized
surgical device or instrument, which incorporates the at least one
trajectory of path and a matching surface to the at least one
surface associated with the patient's anatomy; and (6) fabricating
the customized surgical device or instrument using the
3-dimensional representation.
[0015] According to another aspect of the present disclosure, a
system and method for facilitating a surgical procedure(s)
comprises, but is not limited to: (1) Obtaining data associated
with the patient's anatomy by way of a MRI or CT scan; (2)
Converting the MRI or CT scan data to a 3-Dimensional data set(s);
(3) Determining one or more axes or planes of orientation of a
device to be constructed for use in facilitating the surgical
procedure(s) to be performed on the patient; (4) Modeling the
device for use in facilitating the surgical procedure(s) using the
determined axes and accounting for any other constraints derived
from the converted data set(s); (5) Generating a prototype of the
modeled device by, for example, use of rapid prototyping machinery;
and (6) Preparing the prototype for use during the surgical
procedure(s).
[0016] According to this aspect described above, the method step of
accounting for any other constraints derived from the converted
data set(s) may comprise adjusting the size of the modeled device
to accommodate the space limitations on the surgeon, orienting
elements of the modeled device to avoid certain anatomical
features, creating one or more surfaces that may conveniently be
operatively associated with one or more instruments and/or tools
used in the surgical procedure(s), etc.
[0017] According to yet another aspect of the present disclosure,
the system and method includes use of data obtained from a
radiographic imaging machine, a fluoroscopy, an ultrasonic machine
or a nuclear medicine scanning device.
[0018] In another aspect, the patient-matching features may be
confirmed by one or more additional process, such as fluoroscopy or
other processes known to those of skill in the art.
[0019] In one aspect of the present disclosure, the method
comprises the use of bone density data obtained through a CT scan
of the patient anatomy for use in planning the trajectory of a
surgical guide and corresponding fixation device or instrument,
such as a cutting/routing/drilling instrument intended to penetrate
the boney anatomy. This data may be used in other manners
contemplated and described herein to assist the surgeon in
planning, visualizing or otherwise preparing for the surgical
procedure for the patient.
[0020] In yet another alternative embodiment, the data obtained
from one of the scanning devices described above may be
supplemented or merged with data from a bone density scanner to
fabricate a device that is designed to remain in the patient after
the surgical procedure is completed. It is to be expressly
understood that data from a bone density scanner is not necessary
to practice the inventions described herein, but may supplement the
data and assist a surgeon or other medical professional in
determining the proper location, trajectory, orientation or
alignment of the various apparatus described herein.
[0021] According to yet another aspect of the present disclosure,
data may be supplemented or merged with data from a bone density
scanner to achieve further control over the orientation of any
desired axes, particularly where the surgical procedure involves
insertion of one or more implantable devices.
[0022] According to yet another embodiment, 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.
[0023] 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.
[0024] According to yet another aspect of the present disclosure, a
method for creating a template for use in a surgical operation is
disclosed. The method includes, but is not limited to: (1)
collecting data from the patient corresponding to the patient's
unique anatomy; (2) creating a model of the template from the data
collected, the model comprising a plurality of matching surfaces to
the patient's unique anatomy; (3) providing data associated with
model to fabrication machinery; (4) rapidly generating the template
to comprise the plurality of matching surfaces and further
comprising at least one additional matching surface corresponding
to at least one tool or instrument used in the surgical operation;
and (5) generating a permanent device based on the template for use
in the surgical operation.
[0025] In one embodiment of the present disclosure the model is a
digital model. In another embodiment of the present disclosure the
model is a physical model.
[0026] According to yet another aspect of the present disclosure, a
system for performing a surgical procedure on a patient is
disclosed, comprising:
[0027] a surgical guide;
[0028] the surgical guide comprising a plurality of surfaces
determined from data scanned from the patient, the plurality of
surfaces configured to match the patient's boney anatomy;
[0029] the surgical guide further comprising at least one
trajectory or path determined from the patient's boney anatomy for
facilitating the surgical procedure;
[0030] the surgical guide further comprising at least one sleeve,
the sleeve comprised of a conductive material and having a first
end and a second end;
[0031] an instrument comprising at least a first portion comprised
of a conductive material and adapted to be received within the at
least one sleeve by inserting the at least a first portion in the
first end of the at least one sleeve and contact the conductive
material of the at least one sleeve;
[0032] wherein the at least a first portion of the instrument is
adapted to pass through the at least one sleeve and exit the second
end of the at least one sleeve; and
[0033] wherein the surgical guide may be subject to an electrical
current for providing intra-operative monitoring (IOM) of the
instrument during contact with the surgical guide and with the
patient anatomy.
[0034] Another aspect of the present invention is a system and
method of configuring a rod for use in a surgical procedure. The
method includes the steps of, but is not limited to: (1) obtaining
data associated with a patient's anatomy; (2) converting the data
into a digital model; (3) determining trajectories for a plurality
of fixation devices to be used in the surgical procedure; (4)
modeling the rod based on the trajectories of the fixation devices;
and (5) forming the rod by a rapid prototyping fabrication machine.
The rod produced according to the method has a patient-specific
shape adapted to substantially align with each of the fixation
devices. Optionally, the method may further comprise re-shaping the
rod to alter an amount of correction the rod is adapted to provide
to the patient's anatomy.
[0035] In one embodiment, the method further comprises preparing a
template. In one embodiment, the template has a void that forms a
negative of the patient-specific shape of the rod. In another
embodiment, the template comprises a predetermined portion of the
patient's anatomy and includes fixtures adapted to releasably
interconnect pegs for to the template. Each peg is adapted to model
a trajectory of one of the fixation devices. In one embodiment, the
pegs are adapted to retain the rod in an orientation to be used in
the surgical procedure.
[0036] It is another aspect of the present invention to provide a
patient-specific guide for use in a surgical procedure. The guide
includes, but is not limited to: (1) a medial body having a
proximal portion and a distal portion; (2) a first cannula and a
second cannula, each of the cannulae with proximal and distal
portions, at least one of the first cannula and the second cannula
further comprising a bore oriented in a direction determined from
the anatomical features of a patient, the bore adapted to guide an
instrument or a fixation device in a cortical bone trajectory; and
(3) a surface of one or more of the medial body, the first cannula,
and the second cannula including patient-specific contours
determined from the patient's anatomy and configured to contact and
substantially conform to at least a first subcutaneous anatomic
feature of a vertebra of the patient. In one embodiment, each of
the first and second cannulae include a bore. The bores may have
the same, or different, diameters. In another embodiment, only one
of the first and second cannulae include a bore.
[0037] The guide may further comprise a leg extending from at least
one of the first and second cannulae, the leg including a second
surface including patient-specific contours determined from the
patient's anatomy and configured to contact and substantially
conform to a second anatomic feature of the patient. Additionally,
the medial body may optionally include at least one leg extending
from the medial body, the at least one leg including a second
surface including patient-specific contours determined from the
patient's anatomy and configured to contact and substantially
conform to a second anatomic feature of the patient.
[0038] In one embodiment, the surface with the patient-specific
contours is adapted 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 another embodiment, at least a portion of the guide is
shaped to prevent contact with a portion of the patient's
anatomy.
[0039] In another embodiment, the guide includes at least a third
cannula having a bore that is oriented in a direction determined
from the anatomical features of the patient, the bore adapted to
guide an instrument or a fixation device. In another embodiment,
the bore of the third cannulae is directed in a trajectory that is
not parallel to the bore of the at least one of the first and
second cannulae. In still another embodiment, the third cannulae is
configured to target a predetermined portion of a different
vertebrae of the patient. Optionally, the third cannulae is
releasably interconnected to the guide. In another embodiment, the
third cannulae includes a track having patient-specific depth
control, angle, and orientation adapted to guide an instrument
operable to remove a predetermined portion of the vertebrae. In one
embodiment, the track is oriented to guide the instrument to target
facet capsules of an adjacent vertebrae. In another embodiment, the
track is adapted to target a pedicle of the vertebrae.
[0040] In one embodiment, a cutting guide is interconnected to a
portion of the 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.
[0041] In still another embodiment, the medial body of the guide
comprises a first portion releasably interconnected to a second
portion.
[0042] In another aspect of the present invention, a
patient-specific guide for use in a surgical procedure is provided.
The guide is adapted to contact, or fit on, a predetermined portion
of a vertebra of a patient and generally comprises: (1) a body with
a proximal portion and a distal portion, the body having at least
one of a bore and a track oriented in a predetermined trajectory
determined from anatomical features of the patient, the bore or
track adapted to guide an instrument or a fixation device; and (2)
at least two legs extending from the body, a portion of each leg
comprising patient-specific contours determined from the patient's
anatomy and configured to contact and substantially conform to at
least a first subcutaneous anatomic feature of the vertebra of the
patient. In one embodiment, the bore is directed in a pedicle screw
trajectory. In another embodiment, the bore is directed in a
cortical bone trajectory. In still another embodiment, the body
further comprises a second bore that is oriented in a direction for
placement of a temporary fixation device.
[0043] Optionally, the body may comprise at least two portions. In
one embodiment, the portions of the body are adapted to be
interconnected together.
[0044] In one embodiment, at least a portion of one of the legs is
adapted to hook at least partially around, and substantially
conform to, a second anatomic feature of the patient. In one
embodiment at least one of the legs is adapted to contact a portion
of the patient's anatomy that has been altered by a surgical
procedure. In another embodiment, at least one of the legs is
adapted to contact an unaltered portion of the patient's
anatomy.
[0045] The track includes patient-specific depth control, angle,
and orientation adapted to guide an instrument operable to remove a
predetermined portion of the vertebrae. 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.
[0046] In one embodiment, the guide further comprises a frame. The
frame is configured to be fixed to screws placed in at least one
vertebrae of the patient. 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.
[0047] In still another embodiment, the guide includes a second
bore. The second bore may be oriented in a trajectory that is not
parallel to the other bore. In one embodiment, the bore is adapted
to guide an instrument. In another embodiment, the bore is oriented
in a direction for placement of a temporary fixation device.
[0048] 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.
[0049] 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.
[0050] 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 be removed during a previous
portion of the same surgical procedure. In another embodiment, at
least a portion of the distal portion is shaped to substantially
conform to an unaltered portion of the patient's anatomy.
[0051] In one embodiment, the bore is directed in a cortical bone
trajectory. In another embodiment, the bore is directed in a
pedicle screw trajectory.
[0052] In one embodiment, a cannulae is associated with the body.
The cannulae includes a bore that is oriented in a direction for
placement of a temporary fixation device. Optionally, the body may
further comprise a second bore.
[0053] In another embodiment, the body further comprises at least
one track. The track includes patient-specific depth control,
angle, and orientation adapted to guide an instrument operable to
remove a predetermined portion of the vertebrae. In one embodiment,
the at least one track comprises two tracks formed in the body.
[0054] In one embodiment, the template further includes a frame
configured to be fixed to screws placed in at least one vertebrae
of the patient. The body of the template is adapted to releasably
interconnect to the frame. In this manner, the template may be used
in a surgical procedure before, or after, a different guide or
template of the present invention.
[0055] Further aspects of the present disclosure are directed to
the system described above and further comprising a surgical guide
which is subject to an electrical current by providing at least one
electrode on the conductive material of the surgical guide and
providing electrical current to the at least one electrode.
[0056] Further aspects of the present disclosure provide a method
for manufacturing a surgical guide at an off-site manufacturing
location, an on-site manufacturing location, a clinic, a surgery
center, a surgeon's offices, a public hospital or at a private
hospital.
[0057] Still further aspects of the present disclosure include a
surgical guide manufactured using one of the methods described
herein, wherein the 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.
[0058] Incorporated by reference in their entireties are the
following U.S. patents and patent applications and international
publications directed generally to methods and apparatus related to
surgical procedures, thus providing written description support for
various aspects of the present disclosure. The U.S. patents and
pending applications incorporated by reference are as follows: U.S.
Pat. Nos. 8,758,357, 8,419,740, 8,357,111, 8,298,237, 8,277,461,
8,257,083, 8,214,014, 8,206,396, 8,167,884, 8,159,753, 7,957,824,
7,844,356, 7,658,610, 7,623,902, 7,491,180, 7,235,076, 6,755,839,
6,711,432, 5,201,734, and 3,151,392, U.S. Design Pat. Nos.
D705,929, D669,176, D672,038, D618,796, D606,195, D533,664,
D532,515, D428,989, D420,132, D412,032, D403,066, and D359,557, and
U.S. Pat. Pub. Nos. 2013/0123850, 2013/0053854, 2013/0218163,
2012/0215315, 2012/0179259, 2012/0130434, 2012/0041445,
2011/0319745, 2011/0288433, 2011/0224674, 2011/0218545,
2011/0213376, 2011/0190899, 2011/0184526, 2011/0184419,
2011/0166578, 2011/0160867, 2011/0160736, 2011/0093086,
2011/0093023, 2011/0071533, 2011/0054478, 2011/0046735,
2011/0015639, 2011/0015636, 2010/0324692, 2010/0305700,
2010/0217336, 2010/0217270, 2010/0191244, 2010/0152782,
2010/0100193, 2010/0087829, 2010/0082035, 2010/0049195,
2010/0016984, 2009/0270868, 2009/0254093, 2009/0198277,
2009/0187194, 2009/0138020, 2009/0110498, 2009/0099567,
2009/0093816, 2009/0088763, 2009/0088761, 2009/0088674,
2009/0087276, 2008/0319491, 2008/0312659, 2008/0275452,
2008/0257363, 2008/0183214, 2008/0161815, 2008/0114370,
2007/0288030, 2006/039266, 2006/0241385, 2006/0149375,
2006/0095044, 2006/0084986, 2005/0148843, 2004/0243481, and
2004/0097925. The international publications incorporated by
reference are as follows: European Publication No. EP 2168507, and
World Intellectual Property Organization Pub. Nos. WO 2013/104682,
WO 2013/041618, WO 2012/152900, WO 2011/109260, WO 2011/106711, WO
2011/080260, WO 2011/041398, WO 2010/148103, WO 2010/033431, WO
2009/129063, WO 2008/027549, and WO 2007/145937, and Chinese
Publication Nos. CN 201275138, CN 201404283, CN 101390773, and CN
101953713.
[0059] One having skill in the art will appreciate that embodiments
of the present disclosure may have various sizes. The sizes of the
various elements of embodiments of the present disclosure may be
sized based on various factors including, for example, the anatomy
of the patient, the person or other device operating with or
otherwise using the apparatus, the surgical site location, physical
features of the devices and instruments used with the devices
described herein, including, for example, width, length and
thickness, and the size of the surgical apparatus.
[0060] Embodiments of the present disclosure present several
advantages over the prior art including, for example, the speed and
efficacy of the procedure, the minimally invasive aspects of the
procedure, the disposability of the prototype devices, the ability
to introduce customized implements or tools to the surgical site
with minimal risk and damage to the surrounding tissue, lower risk
of infection, more optimally placed and/or oriented guides and
implantable devices, a more stable and controlled method of placing
and inserting of apparatus associated with the surgical procedure
further reducing the likelihood of the apparatus becoming
misaligned or dislodged, and fewer and/or less expensive tools and
instruments in a surgical site, among other advantages. For
example, the embodiments reduce the number and need for multiple
trays, instruments and different size devices used in a particular
surgery, thereby reducing the cost of the equipment necessary to
complete the surgery. The embodiments also reduce the cumulative
radiation exposure to both the surgeon and medical professionals in
the operating environment and the patient.
[0061] One having skill in the art will appreciate that embodiments
of the present disclosure may be constructed of materials known to
provide, or predictably manufactured to provide the various aspects
of the present disclosure. These materials may include, for
example, stainless steel, titanium alloy, aluminum alloy, chromium
alloy, and other metals or metal alloys. These materials may also
include, for example, PEEK, carbon fiber, ABS plastic,
polyurethane, polyethylene, photo-polymers, resins, particularly
fiber-encased resinous materials rubber, latex, synthetic rubber,
synthetic materials, polymers, and natural materials.
[0062] One having skill in the art will appreciate that embodiments
of the present disclosure may be used in conjunction devices that
employ automated or semi-automated manipulation. Embodiments of the
present disclosure may be designed such that the apparatus may be
formed and verified, for example, remotely by an operator, remotely
by an operator through a computer controller, by an operator using
proportioning devices, programmatically by a computer controller,
by servo-controlled mechanisms, by hydraulically-driven mechanisms,
by pneumatically-driven mechanisms or by piezoelectric actuators.
It is expressly understood for purposes of this disclosure that
other types of machinery other than rapid prototyping machinery may
be employed in the systems and methods described herein, for
example, by computerized numerical control (CNC) machinery.
[0063] The Summary of the Invention is neither intended nor should
it be construed as being representative of the full extent and
scope of the present disclosure. The present disclosure is set
forth in various levels of detail in the Summary of the Invention
as well as in the attached drawings and the Detailed Description of
the Invention and no limitation as to the scope of the present
disclosure is intended by either the inclusion or non-inclusion of
elements, components, etc. in this Summary of the Invention.
Additional aspects of the present disclosure will become more
readily apparent from the Detailed Description, particularly when
taken together with the drawings.
[0064] The above-described benefits, embodiments, and/or
characterizations are not necessarily complete or exhaustive, and
in particular, as to the patentable subject matter disclosed
herein. Other benefits, embodiments, and/or characterizations of
the present disclosure are possible utilizing, alone or in
combination, as set forth above and/or described in the
accompanying figures and/or in the description herein below.
However, the claims set forth herein below define the
invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0065] The accompanying drawings, which are incorporated in and
constitute a part of the specification, illustrate embodiments of
the disclosure and together with the general description of the
disclosure given above and the detailed description of the drawings
given below, serve to explain the principles of the
disclosures.
[0066] It should be understood that the drawings are not
necessarily to scale. In certain instances, details that are not
necessary for an understanding of the disclosure or that render
other details difficult to perceive may have been omitted. It
should be understood, of course, that the disclosure is not
necessarily limited to the particular embodiments illustrated
herein.
[0067] In the drawings:
[0068] FIG. 1 is a perspective view of a three-dimensional model of
a unique grouping of anatomical features from which a set of data
points may be derived according to one embodiment of the present
disclosure;
[0069] FIG. 2 is a flow chart diagram showing the various steps of
performing a method of manufacturing and using an apparatus for
facilitating a surgical procedure according to one embodiment of
the present disclosure;
[0070] FIG. 3 is a perspective view of an apparatus according to
yet another alternative embodiment of the present disclosure;
[0071] FIG. 4A is a perspective view of a cutting guide according
to yet another alternative embodiment of the present
disclosure;
[0072] FIG. 4B is a perspective view according to the embodiment
shown in FIG. 4A;
[0073] FIG. 5A is a perspective view of a cutting tool according to
yet another alternative embodiment of the present disclosure;
[0074] FIG. 5B is a detailed perspective view according to the
embodiment shown in FIG. 5A;
[0075] FIG. 5C is another perspective view according to the
embodiment shown in FIG. 5A depicted with the cutting guide of FIG.
4A;
[0076] FIG. 6A is yet another perspective view according to the
embodiment shown in FIG. 5A depicted with the cutting guide of FIG.
4A;
[0077] FIG. 6B is another perspective view according to the
embodiment shown in FIG. 5A depicted with the cutting guide of FIG.
4A;
[0078] FIG. 7A is a front elevation view of a guide of another
embodiment of the present invention positioned against a vertebral
body;
[0079] FIG. 7B 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. 7A;
[0080] FIG. 7C is a side view of a guide sleeve of an embodiment of
the present invention positioned proximate to the vertebral body
illustrated in FIG. 7A;
[0081] FIG. 7D is side view of a cutting tool of an embodiment of
the present invention inserted into a cannula of the guide sleeve
of FIG. 7C;
[0082] FIG. 7E is a perspective view of the cutting tool and the
guide sleeve of FIG. 7D;
[0083] FIGS. 7F-7G are additional perspective views of the cutting
tool and the guide sleeve of FIG. 7D;
[0084] FIG. 8A is a front elevation view of a frame of an
embodiment of the present invention interconnected to a portion of
a patient's spine;
[0085] FIG. 8B is a front elevation view of a guide of another
embodiment of the present invention interconnected to the frame of
FIG. 8A;
[0086] FIG. 8C is a perspective view of the guide and the frame of
FIG. 8B;
[0087] FIG. 8D is another perspective view of the guide and the
frame of FIG. 8B including hidden lines showing the structure of
slots formed in the guide;
[0088] FIG. 9A is a front elevation view of a guide of another
embodiment of the present invention;
[0089] FIG. 9B is a rear elevation view of the guide of FIG.
9A;
[0090] FIG. 9C is a bottom perspective view of the guide of FIG.
9A;
[0091] FIG. 9D is another front elevation view of the guide of FIG.
9A positioned against a vertebral body and including hidden lines
showing the structure of slots formed in the guide;
[0092] FIG. 9E is a perspective view of the guide of FIG. 9A
positioned against the vertebral body and including hidden
lines;
[0093] FIG. 9F is a side elevation view of the guide of FIG. 9A
positioned against the vertebral body;
[0094] FIG. 9G is another side elevation view of the guide of FIG.
9A positioned against the vertebral body and illustrating cuts
formed in the vertebral body;
[0095] FIG. 10A is a front elevation view of still another guide of
an embodiment of the present invention;
[0096] FIG. 10B is another front elevation view of the guide of
FIG. 10A positioned against a vertebral body;
[0097] FIG. 10C is a side perspective view of the guide of FIG.
10A;
[0098] FIG. 10D is a side view of the guide of FIG. 10A positioned
against the vertebral body;
[0099] FIG. 10E is a top view of the guide of FIG. 10A positioned
against the vertebral body;
[0100] FIG. 11A is a front elevation view of yet another guide of
an embodiment of the present invention;
[0101] FIG. 11B is another front elevation view of the guide of
FIG. 11A positioned against a vertebral body;
[0102] FIG. 11C is a side perspective view of the guide of FIG.
11A;
[0103] FIG. 11D is another side perspective view of the guide of
FIG. 11A positioned against the vertebral body;
[0104] FIG. 11E is a side view of the guide of FIG. 11A positioned
against the vertebral body;
[0105] FIG. 12A is a front elevation view of a frame of an
embodiment of the present invention interconnected to a portion of
a patient's spine;
[0106] FIG. 12B is a elevation view of another guide of an
embodiment of the present invention interconnected to the frame of
FIG. 12A;
[0107] FIG. 12C is a perspective view of the guide and frame of
FIG. 12B;
[0108] FIGS. 13A-13B are perspective views of still another guide
of an embodiment of the present invention;
[0109] FIG. 13C is a perspective view of the guide of FIG. 13A
positioned against a vertebral body that has been altered in a
surgical procedure;
[0110] FIG. 13D is a front elevation view of the guide of FIG. 13A
positioned against a portion of the patient's spine that has been
altered in a surgical procedure and further illustrating the guide
in relation to a neural element of the patient;
[0111] FIG. 13E is a perspective view of the guide of FIG. 13A
positioned against a portion of the patient's spine that has been
altered in a surgical procedure and showing the guide positioned
proximate to the neural element of the patient;
[0112] FIGS. 14A-14B are perspective views of a guide of yet
another embodiment of the present invention;
[0113] FIGS. 14C-14D are additional perspective view of the guide
of FIGS. 14A-14B positioned against a vertebral body that has been
cut to remove portions of the vertebrae;
[0114] FIG. 14E is another perspective view of the guide of FIG.
14A positioned against the vertebral body and neural elements of
the patient;
[0115] FIG. 15A is a perspective view of yet another guide of the
present invention;
[0116] FIG. 15B is a side view of the guide of FIG. 15A positioned
in contact with a vertebral body that includes cuts formed using
the guide;
[0117] FIG. 15C is a perspective view of the guide of FIG. 15A
positioned in contract with the vertebral body of FIG. 15B;
[0118] FIG. 15D is a front elevation view of the guide of FIG. 15A
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;
[0119] FIG. 15E is a side perspective view of the guide of FIG. 15D
in a similar position of use;
[0120] FIG. 16A is a perspective view of a model of an embodiment
of the present invention;
[0121] FIG. 16B is a side elevation view of the model of FIG.
16A;
[0122] FIG. 16C is rear elevation view of the model of FIG.
16A;
[0123] FIG. 16D is a perspective view of the model of FIG. 16A
positioned in contact with a vertebral body;
[0124] FIG. 16E is a side elevation view of the model of FIG. 16A
positioned in contact with the vertebral body of FIG. 16D;
[0125] FIG. 17A is a front elevation view of another model of an
embodiment of the present invention;
[0126] FIG. 17B is a rear elevation view of the model of FIG.
17A;
[0127] FIG. 17C is a rear perspective view of the model of FIG.
17A;
[0128] FIG. 17D is another front elevation view of the model of
FIG. 17A in a position of use against a vertebral body;
[0129] FIG. 17E is a front perspective view of the model of FIG.
17D;
[0130] FIG. 17F is a top perspective view of the model of FIG.
17D;
[0131] FIG. 18A is a front perspective view of another embodiment
of a model of the present invention;
[0132] FIG. 18B is a front elevation view of the model of the
embodiment of FIG. 18A positioned proximate to a vertebral
body;
[0133] FIG. 18C is a perspective view of the model and vertebral
body of FIG. 18B;
[0134] FIG. 19A 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;
[0135] FIG. 19B is a perspective view of the model and the guide of
FIG. 19A in an assembled state;
[0136] FIG. 19C is a front elevation view of the model and the
guide of FIG. 19B;
[0137] FIG. 19D is a perspective view of the model and the guide of
FIG. 19B positioned proximate to a vertebral body;
[0138] FIG. 19E is a front elevation view of the model and the
guide of FIG. 19D positioned proximate to the vertebral body;
[0139] FIG. 20A is a perspective view of still another embodiment
of a model of the present invention;
[0140] FIG. 20B is a side elevation view of the model of FIG.
20A;
[0141] FIG. 20C is a perspective view of the model of FIG. 20A
interconnected to a frame of the present invention similar to the
frame of FIG. 12A, illustrating the model in a position of use
proximate to a portion of the patient's spine;
[0142] FIG. 20D is a side elevation view of the model of FIG.
20C;
[0143] FIG. 21A is a perspective view of another embodiment of a
model of the present invention;
[0144] FIG. 21B is a side perspective view of the model of FIG.
21A;
[0145] FIGS. 21C-21D are views of the model of FIG. 21A in a
position of use interconnected to a frame of the present invention,
the frame fixed to a portion of a patient's spine;
[0146] FIG. 22A 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;
[0147] FIG. 22B is a side elevation view of the three-dimensional
model of FIG. 22A;
[0148] FIG. 22C is a perspective view of the removed spine portion
after some of the removed spine portion has been cut away;
[0149] FIG. 22D is a side elevation view of the three-dimensional
model of FIG. 22D after the model has been moved to close a gap
formed after a portion of the spine was removed;
[0150] FIG. 22E is a side elevation view of the three-dimensional
model of FIG. 22B 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;
[0151] FIG. 22F is another side elevation view of the
three-dimensional model of FIG. 22D and further illustrating the
alignment indicator of FIG. 22E interconnected to the
three-dimensional model and with the model showing the alignment of
the patient's spine after the planned surgical procedure;
[0152] FIG. 23A 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;
[0153] FIG. 23B is a front elevation view of the tool of FIG.
23A;
[0154] FIG. 23C is a bottom elevation view of the tool of FIG.
23A;
[0155] FIG. 23D is a top elevation view of the tool of FIG.
23A;
[0156] FIG. 24A 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;
[0157] FIG. 24B is a front elevation view of the tool of FIG.
24A;
[0158] FIG. 24C is a top elevation view of the tool of FIG.
24A;
[0159] FIG. 24D is a right side elevation view of the tool of FIG.
24A;
[0160] FIG. 25A is a front elevation view of another tool of an
embodiment of the present invention for verification of coronal
alignment;
[0161] FIG. 25B is a right side elevation view of the tool of FIG.
25A;
[0162] FIG. 25C is a perspective view of the tool of FIG. 25A;
[0163] FIG. 25D is a front view of the tool of FIG. 25A proximate
to a portion of the patient's spine and aligned in relation to the
sagittal plane;
[0164] FIG. 25E is a side view of the tool of FIG. 25D proximate to
the patient's spine and aligned in relation to the coronal
plane;
[0165] FIG. 26A-26B 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;
[0166] FIGS. 27A-D 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;
[0167] FIG. 27E illustrates various inserts adapted for use with
the patient-specific guides of the present invention;
[0168] FIGS. 28A-C are various views of the guide of FIGS. 27A-C
shown in relation to a vertebral body of a patient;
[0169] FIGS. 29A-C 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;
[0170] FIGS. 30A-B are various view of still another embodiment of
a patient-specific guide of an embodiment of the present
invention;
[0171] FIGS. 31A-C are various views of another patient-specific
guide of an embodiment of the present invention;
[0172] FIGS. 32A-C 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;
[0173] FIGS. 33A-F 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;
[0174] FIGS. 34A-34F are various views of a patient-specific bone
model of an embodiment of the present invention adapted for use to
form a surgical rod for use in a surgical procedure;
[0175] FIG. 35A-35E provide views of a configurable template of an
embodiment of the present invention that can be used to shape a
surgical rod;
[0176] FIG. 36 illustrates embodiments of pegs of embodiments of
the present invention adapted for use with the model and template
of FIGS. 34-35;
[0177] FIGS. 37A-37B are views of a template of yet another
embodiment of the present invention;
[0178] FIGS. 38A-38B are views of a rod of one embodiment of the
present invention in position proximate to a patient's spine;
[0179] FIG. 39 is a flow diagram of a method of the present
invention for configuring a rod for use in a surgical procedure;
and
[0180] FIG. 40A-40B are various view of still another embodiment of
a patient-specific guide of an embodiment of the present
invention.
DETAILED DESCRIPTION
[0181] 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. According to one alternate embodiment
described herein, the patient-matched apparatus may be further
matched with at least other apparatus used during the surgical
procedure. Other features of the disclosure will become apparent
after a review of the following disclosures and varying embodiments
of the invention.
[0182] Multiple embodiments of the disclosure are depicted in FIGS.
1-40. Referring now to FIG. 1, a perspective view of a
three-dimensional model of a unique grouping of anatomical features
according to one embodiment of the present disclosure is shown.
Here, the model 2 is comprised of multiple vertebral bodies 4, 6
but according to other embodiments may be comprised of any
anatomical grouping for a particular patient. Data associated with
the model 2 may be captured from a MRI or CT scan or from
radiographic images of the patient's corresponding boney anatomy
(or alternatively from other data sources). The data, once
captured, may be converted using known software tools to a computer
aided design (CAD) program, where the data set is representative of
the model 2 and may be used to provide additional data points for
forming the contours, sizes, shapes and orientations of one or more
apparatus to be used in the surgical procedure.
[0183] According to an alternative embodiment, the data may be
obtained from an ultrasonic or nuclear medicine scanning device. In
yet another alternative embodiment, the data may be supplemented or
merged with data from a bone density scanner to fabricate a device
that is designed to remain in the patient after the surgical
procedure is completed, or alternatively to achieve further control
over the orientation of any desired axes, particularly where the
surgical procedure involves insertion of one or more implantable
devices.
[0184] FIG. 2 is a flow chart showing the various steps of
performing a method of manufacturing an apparatus, such as a guide,
a spinal fusion rod, or a template of a predetermined portion of a
patient's anatomy according to various embodiments described
herein, for use in facilitating a surgical procedure. While a
general order for the steps of the method is shown in FIG. 2, the
method can include more or fewer steps or can arrange the order of
the steps differently than those shown in FIG. 2. The method,
according to a preferred embodiment, comprises, but is not limited
to, the following steps:
[0185] A) Obtaining data associated with the patient's anatomy by
way of, but not limited to, a MRI or CT scan;
[0186] B) Converting the MRI or CT scan data to a 3-Dimensional
data set(s);
[0187] C) Determining one or more axes of orientation of a device
to be constructed for use in facilitating the surgical procedure(s)
to be performed on the patient;
[0188] D) Modeling the device for use in facilitating the surgical
procedure(s) using the determined axes and accounting for any other
constraints derived from the converted data set(s);
[0189] E) Generating a prototype of the modeled device by, for
example, use of rapid prototyping machinery; and
[0190] F) Preparing the prototype for use during the surgical
procedure(s).
[0191] As shown in FIG. 2, the method may comprise additional steps
or may be repeated for additional devices used in the surgical
procedure. The step of obtaining data is typically performed in a
traditional manner, by subjecting the patient to a scan using, for
example, MRI or CT or other suitable scanning equipment known in
the art. The data is then captured by the equipment and may be
converted to a 3-Dimensional data set(s) by software or other
algorithmic means known in the art, such as by exporting the data
into a known modeling software program that allows data to be
represented, for example, in CAD format. Once this data is
converted, a device may be modeled to complement the data set(s)
and oriented by one or more axes determined by the surgeon either
before or through observation of the data set(s) from the initial
scan of the patient's anatomy.
[0192] The method step of accounting for any other constraints
derived from the converted data set(s) may comprise adjusting the
size of the modeled device to accommodate the space limitations on
the surgeon, orienting elements of the modeled device to avoid
certain anatomical features, creating one or more surfaces that may
conveniently be operatively associated with one or more instruments
and/or tools used in the surgical procedure(s), etc. The prototype
may be generated using known rapid prototyping machinery, or
alternatively by milling machinery such as a CNC milling machine.
Alternatively, the initial device fabricated by this method may be
in a temporary state for further consideration and or manipulation
by the surgeon, and then finally constructed using one of the
methodologies described herein. The steps may be repeated for
complementary devices, some or all of which may include further
matching surfaces for the patient's anatomy or to the previously
fabricated devices (i.e., the devices fabricated may have matching
surfaces for adjoining together one or more devices, as described
in greater detail below).
[0193] Alternatively, the system and method described herein may
facilitate the alignment of various anatomical features for a
particular patient, such as, for example, multiple vertebral bodies
in a patient to correct spinal deformities. For example, the data
set(s) may provide an initial location for the anatomical features,
but may be further manipulated by the surgeon in a pre-operative
setting to create a desired data set(s), such as a final location
for the anatomical features once the surgical procedure(s) are
completed. In this manner, the devices formed by the system and
method described above may be used in either an initial location or
a final location for the anatomical features, and be matched to
those specific locations and orientations for each stage of the
surgical procedure. These staged devices would in turn provide the
surgeon with a visual guide to determine the degree of correction
achieved through the surgical procedure, as compared to the
pre-operative plan. Other variations on the method of the present
disclosure are described in the Summary of the Invention and
included in the appended claims.
[0194] Fabrication methods may comprise the use of a rapid
prototyping machine, such as a stereolithography (STL) machine,
selective laser sintering (SLS) machine, or a fused deposition
modeling (FDM) machine, direct metal laser sintering (DMLS),
electron beam melting (EBM) machine, or other additive
manufacturing machine. One example of such a rapid prototyping
machine is commercially available from 3D Systems and known as
Model SLA-250/50. The rapid prototyping machine selectively hardens
a liquid, powdered or other non-hardened resin or metal into a
three-dimensional structure, which can be separated from the
remaining non-hardened resin, washed/sterilized and used directly
as the apparatus. The prototyping machine receives the individual
digital data sets and produces one structure corresponding to each
of the desired apparatus.
[0195] Generally, because stereolithographic machinery produces a
resin, which may have less than optimal mechanical properties
(which may not be generally acceptable for a particular surgical
use), the prototyping machine may alternatively be used to produce
a mold. After the model is prepared, a conventional pressure or
vacuum molding machine may be used to produce the apparatus from a
more suitable material, such as stainless steel, titanium alloy,
aluminum alloy, chromium alloy, PEEK, carbon fiber, or other metals
or metal alloys.
[0196] According to another alternative embodiment, the system and
method may comprise providing the data set(s) to a CNC machine,
which in turn may be utilized to manufacture a custom milled
apparatus from one of the more mechanically sound materials listed
above. In yet another alternative embodiment, volume manufacturing
of apparatus in accordance with the embodiments described herein
may also be achieved, for example, where a particular orientation
or insertion trajectory is common among a large grouping of
patients.
[0197] According to one particular embodiment of the present
disclosure, a system and method is provided for fabricating
apparatus for use with a variety of surgical procedures associated
with a patient's spine. Individuals who suffer degenerative disc
disease, natural spine deformations, a herniated disc, spine
injuries or other spine disorders often require surgery on the
affected region to relieve the individual from pain and prevent
further injury. Such spinal surgeries may involve removal of
damaged joint tissue, insertion of a tissue implant and/or fixation
of two or more adjacent vertebral bodies, with the surgical
procedure varying depending on the nature and extent of the
injury.
[0198] For patients with varying degrees of degenerative disc
disease and/or nerve compression with associated lower back pain,
spinal fusion surgery, or lumbar arthrodesis ("fusion") is commonly
used to treat the degenerative disease. Fusion commonly involves
distracting and/or decompressing one or more intervertebral spaces,
followed by removing any associated facet joints or discs, and then
joining or "fusing" two or more adjacent vertebra together. Fusion
of vertebral bodies also commonly involves fixation of two or more
adjacent vertebrae, which may be accomplished through introduction
of rods or plates, and screws or other devices into a vertebral
joint to join various portions of a vertebra to a corresponding
portion on an adjacent vertebra.
[0199] Fusion may occur in the lumbar, thoracic or cervical spine
region of a patient. Fusion requires tools for accessing the
vertebrae and implanting the desired implant, any bioactive
material, etc. Such procedures often require introduction of
additional tools and/or instruments, including drills, drill
guides, debridement tools, irrigation devices, vises, clamps,
cannulae, retractors, distracters, cutting tools, cutting guides
and other insertion/retraction tools and instruments. The
insertion, alignment and placement of these tools, instruments and
fixation devices are critical to the success of the operation. As
such, providing a customized and patient-specific tool or
instrument increases the likelihood that the surgical procedure
will be successful.
[0200] FIG. 3 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.
[0201] The guide 10 illustrated in FIG. 3 is a laminectomy guide
adapted to facilitate the use of surgical cutting instruments to
alter the patient's lamina. 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.
[0202] In the embodiment of the present invention illustrated in
FIG. 3, 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 below. 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. In this manner, the
surface 14 provides a reference to align the guide 10 with a
predetermined portion of the patient's anatomy.
[0203] A single guide 10 may target one portion of the lamina.
Alternatively, the guide may be sized to facilitate a procedure
targeting more than one portion of the patient's anatomy,
including, for example, both sides of the lamina substantially
simultaneously.
[0204] The laminectomy cutting guide 10 illustrated in FIG. 3
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 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.
[0205] The cutting slot 20 may be sized or shaped to receive a
particular cutting tool and to 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 20 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. 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.
[0206] 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 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. 5, that limits the depth of insertion of the
tool.
[0207] Optionally, a sleeve 24 or an insert is provided for 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.
[0208] It will be appreciated that the insert 24 may have any size
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.
[0209] 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.
[0210] 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 may 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 guide.
[0211] 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 has a compound shape, such as
slot 20 with three different portions, 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.
[0212] Additionally or alternatively, the insert may 24 include
stops to limit an angle of use of the cutting tool during the
surgical procedure. Indicia 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.
[0213] The alignment channel 16 may receive a fixture, such as a
pedicle screw, to temporarily fix the guide 10 to the patient's
spine. 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.
[0214] 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 simulated, a guide 10 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
for creating patient-specific features as described above.
[0215] Although shown in FIG. 3 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. At least a portion of
the proximal end of the guide is configured to extend outside of
the patient during a surgical procedure.
[0216] Referring now to FIGS. 4A-4B, further illustrations of a
cutting guide 110 (similar to the guide 10 depicted in FIG. 3
above), 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 FIGS. 5A-C) 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.
[0217] According to the embodiment shown in connection with FIGS.
4-6, 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.
[0218] These patient-specific cutting guides 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. This is due in part
to the intimate relationship of the vascular and neural elements to
the boney structures, which create navigational challenges for a
surgeon to safely and efficiently resect the bone during one of
these procedures. This is especially true from a posterior
approach. 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 relation to FIGS. 4-6, may also provide a degree
of depth control essential for avoiding contact with vascular and
neural elements.
[0219] In one embodiment, the cutting tool 140 associated with the
cutting guide 110 shown in FIGS. 4-6 is typical of the type of
tools currently used in surgical procedures today. 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. 5A-5C, 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.
[0220] As shown in greater detail in FIGS. 6A-6B, the protrusion
144 may be inserted into a first portion 120C of the "track" 120 of
the cutting guide 110, but not permitted to insert a second or
third deeper portions 120A, 120B of the "track" of a cutting guide
(through which the cutting surface is permitted to travel), thereby
insuring proper depth of the cutting instrument. Further
geometrical configurations other than those shown in FIGS. 6A-6B
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 relative to the cutting guide may be
variable about the "track" 110 of the cutting guide.
[0221] 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.
[0222] Other benefits achieved from the use of these
patient-specific cutting guides include: providing means to achieve
quick and controlled removal of bone; providing spatial orientation
of cutting tools used during the procedure; ensuring correct
orientation of cuts, both through controlled guiding of the
instrument and visualization during the pre-surgical planning
process; providing accurate calculation of deformity correction,
prior to cutting; providing accurate bone resection, which in turn
ensures deformity correction; depth controlled cutting restrictions
to protect neural and vascular elements; controlled cutting vector
and avoiding contact or injury to neural elements; and ability to
provide approach for cuts in a posterior, anterior, posterior
lateral, transforaminal or direct lateral approach.
[0223] Referring now to FIGS. 7A-7F, 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.
[0224] In one embodiment of the present invention, a surgical guide
246, guide sleeve 248 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.
[0225] 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.
[0226] Referring now to FIGS. 7C-7G, 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.
[0227] 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 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.
[0228] Referring now to FIGS. 8A-8D, 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.
[0229] In use, the frame 330 is interconnected to fixtures 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 fixtures 334 may be pedicle
screws. Although two screws 334 in each of the inferior and
superior vertebra VI, VS are illustrated in use with the frame of
the embodiment of FIG. 8, 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. 8A 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. Accordingly, the shape of the
frame is adapted to ensure proper alignment of the frame and the
guide, limiting the possibility of misuse of the frame and
guide.
[0230] The pedicle screws 334 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 co-pending U.S. patent application
Ser. No. 14/298,634 which is incorporated herein in its
entirety.
[0231] The frame 330 serves multiple purposes. For example, the
frame 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 frame 330
may only permit docking of the guide when the guide is in a
pre-planned orientation with respect to the targeted vertebrae.
[0232] 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 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.
[0233] 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 with targeted portions
of the medial vertebrae VM in a patient-specific location so that
cuts are made accurately.
[0234] Although the embodiment of the guide 310 illustrated in
FIGS. 8B-8D 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.
[0235] 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. 8B-8D 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
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.
[0236] 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.
[0237] Although not illustrated, it will be appreciated that one or
more cannula or bores may be associated with the guide 310. For
example, in one embodiment, the guide includes a bore the same as,
or similar to, the alignment channels 16, 116 described above.
[0238] Referring now to FIGS. 9A-9G, 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.
[0239] The guide 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.
[0240] 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. 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 a frame 330 as described
above.
[0241] 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. 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 presurgically planned entry points and
angles of cuts for the procedure. As will be appreciated, the slots
may be oriented in a plane transverse to the proximal surface
portion of the guide. 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 may receive sleeves and can include stops and keys.
[0242] 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.
[0243] In one embodiment, as illustrated in FIGS. 9E-9G, the guide
410 is anchored to the vertebrae by an anchor 434. After the cuts
450 (illustrated in FIG. 9G) 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.
[0244] FIGS. 10A-10E 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 described above, 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 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.
[0245] An aperture 528 is formed through the guide 510. The
aperture has 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.
[0246] The guide further includes a pedicle aperture 529. The
pedicle aperture 529 has a pre-planned shape to at least partially
receive the pedicle P of the patient. The pedicle aperture may
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 the aperture 529. In conjunction with a protrusion formed on
the tool, such as the protrusion 144 described above, the key may
control or alter the depth of insertion of the tool as the surgeon
move the tool around the aperture.
[0247] The guide 510 may also include a cutting track 520. The
track 520 is similar to slots 20, 120 described above and may
receive a guide sleeve, 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.
[0248] Although not illustrated, the guide 520 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 520 to the vertebrae.
Optionally, the cannula may be adapted to guide an instrument,
including a boring instrument.
[0249] Referring now to FIGS. 11A-11E, still another embodiment of
a guide 610 of the present invention is illustrated. The guide 610
is similar to guide 510. The distal surface 615 of the guide 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 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.
[0250] 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.
[0251] 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 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 or the protrusion 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 reference to
indicate when the guide 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.
[0252] Referring now to FIGS. 12A-12C, 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.
[0253] 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 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.
[0254] 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. Changing the length of the medial member 732 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 to provide a desire amount
of distraction between vertebrae VS, VM, VI.
[0255] As will be appreciated by one of skill in the art, the frame
may have different shapes and sizes. For example, in another
embodiment, the frame 730 may comprise two medial members. Each
medial member 732 may have a length that is independently
adjustable. Still other embodiments of the frame are contemplated
for use with the guide of the present invention.
[0256] 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.
[0257] 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.
[0258] 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.
[0259] Although not illustrated, the guide 710 may also include
cannula similar to cannula 16, 416 describe above. The cannula may
receive a fixture interconnect the guide 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.
[0260] Referring now to FIGS. 13-14, 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, the second portion 814B contacts
a different plane of the patient's anatomy compared to portion
814A.
[0261] The guides can have a variety of sizes and shapes. In one
embodiment, the guides 810 have a size selected to fit at least
partially across the surface of the vertebra. Additionally or
alternatively, each guide may include armatures. The armatures may
interconnect the guides 810 to a fixture, such as a screw, located
in the vertebrae VM or in an adjacent superior or inferior
vertebrae VS, VI. The armatures may also contact the vertebra in
various locations. Further, the guides 810 may include a cannula
similar to cannula 16, 116, 416. The cannula may receive a fixture
to interconnect the guide to one of the vertebrae at least during
the surgical procedure. Optionally, the cannula may be used to
interconnect the guide 810 to a frame such as frames 330, 730. In
another embodiment, the cannula are adapted to guide an
instrument.
[0262] The guides 810 include slots 820 to target portions of the
vertebrae. The slots may be the same as, or similar to, the slots
of any other guide described herein. The slots may have any
orientation and size. In one embodiment, the slots 820A, 820B are
positioned in planes that are not parallel to each other. Each slot
may have a unique size and may be associated with a specific tool.
Further, the slots may receive sleeves, similar to sleeves 24,
formed of a durable material, such as a metal, to prevent damage to
the guide. The sleeves also prevent the cutting tool guided by the
slot from changing the dimensions of the slot.
[0263] Although the guides 810 illustrated in FIGS. 13-14 include
two slots, it will be appreciated that the guides may include any
number of slots. Further, the guides 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 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.
[0264] A recess 854 is 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 "C" or a vaulted ceiling. The recess 854 includes an
interior surface 856, illustrated in FIG. 13A, that is spaced from
an interior surface of the slots 820. In this manner, the recess
protects the neural element N from inadvertent damage as a tool is
guided in the slot to form a cut in the vertebrae.
[0265] Referring now to FIG. 14, guide 810B is similar to guide
810A. Additionally, guide 810B includes a second recess 854A. The
second recess is shaped to protect a second neural network, N2,
such as a nerve root, from damage.
[0266] Referring now to FIGS. 15A-15E, 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).
[0267] The 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 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 guide 910. The guide includes
patient-specific features 914 that allow it to fit in a
predetermined 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.
[0268] 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. Although the slots 920 are illustrated on
only one side of the guide, it will be appreciated that slots may
be formed on each side of the guide. Further, the guide may include
a bore or a cannula adapted to guide an instrument or fixation
device.
[0269] Referring now to FIGS. 16-21, 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 method described in conjunction with FIGS. 1-2
may be used to form the models. For example, after the patient's
anatomy is imaged, such as by CT image or other imaging device, a
computer model of the anatomy is formed. The models may then 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
model can includes surfaces and indications aligning with cuts of
any size and shape, including cut 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.
[0270] The models are then manufactured by any method. In one
embodiment, the models are manufactured using a rapid manufacturing
process such as 3D printing, although other processes are
contemplated. The models can be fit to the patient's anatomy during
surgery to help the surgeon visualize the correct angles and
starting locations for cuts, including osteotomy cuts. In one
embodiment, the models include cannula. The cannula are adapted to
receive fixtures adapted to at least temporarily interconnect the
model to portions of the patient's anatomy. Fixtures may also be
received in the cannula to interconnect portions of a modular model
together.
[0271] Referring now to FIGS. 16A-16E, 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 the vertebrae.
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 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. In this manner, when properly aligned with the patient's
anatomy as planned, the model 1002 may be releasably retained in a
predetermined alignment with respect to the patient's anatomy.
[0272] 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. 16E, 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 cannula to guide cuts and bores into portions of the vertebrae.
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 guide 1002 illustrated in FIG. 16E is increased,
less of the spinous process S will be removed by a cut guide by
surface 1013. In the alternative, more of the spinous process S can
be removed by decreasing the height of the guide.
[0273] Referring now to FIGS. 17A-17F, 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.
[0274] As will be appreciated, the model 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.
[0275] FIGS. 18A-18C 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 in a procedure using model 1102.
[0276] 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.
[0277] Referring now to FIGS. 19A-19E, 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 and the bores are
illustrated on the first portion, it will be appreciated the guide
portion and the first portion may each comprise projections and
corresponding bores. Further, other features adapted to
interconnect portions 1208, 1210 are contemplated and may be used
with the model of the present invention.
[0278] 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.
[0279] 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 limit the depth of insertion of the tool.
Further, the tracks 1220 may have an asymmetric alignment.
[0280] Referring now to FIGS. 20-21, 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, the 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. However, as will be
appreciated by one of skill in the art, the models are not required
to contact the medial vertebrae.
[0281] 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.
[0282] 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.
[0283] 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.
[0284] 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.
[0285] Referring now to FIGS. 22A-22F, still another embodiment of
a model 1402 of an embodiment of the present invention is
illustrated. Model 1402 is similar to model 2, described above in
conjunction with FIG. 1. The model 1402 may be formed according to
the method of FIG. 2 or by any other method.
[0286] 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.
[0287] 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, position in the model 1402.
[0288] 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. 22C. 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.
[0289] 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.
[0290] 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. 22D, 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.
[0291] 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. 22E-22F. In
one embodiment, the indicators comprise rods with a curvilinear
shape. It will be appreciated that the indicators may comprise
different forms. The indicators simulate how the sagittal alignment
of the patient's spine is altered by the presurgically planned
osteotomy angles.
[0292] A variety of patient specific verification tools,
illustrated in FIGS. 23-26, can be preoperatively 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. 23-26 offer visual or tactical
feedback to the surgeon during or after a surgical procedure.
[0293] Referring now to FIGS. 23-24, 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.
[0294] The tools 1501A, 1501B are designed using patient specific
data and may be manufactured by any method. In one embodiment, the
tools are designed and manufactured as described above in
conjunction with FIGS. 1-2. The tools 1501 generally comprise
armatures 1570 extending from a medial body 1572. The medial body
1572 simulates a planned coronal alignment.
[0295] Some of the armatures may be interconnected to portions of
the patient's anatomy. In one embodiment, illustrated in FIGS.
23A-23D, the armatures may be interconnected to pedicle screws
positioned in at least one of the ilium and the sacrum. In another
embodiment, the tool 1501B is interconnected to only the
sacrum.
[0296] 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
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.
[0297] 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 armatures 1570 extending from the medial
body 1572. In another embodiment, the tool 1501B includes three
armatures 1570 extending from the medial body.
[0298] 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.
[0299] Yet another embodiment of a tool 1601 of an embodiment of
the present invention is illustrated in FIGS. 25A-25E. 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 is one of the guides described hereinafter in
conjunction with FIGS. 27-33.
[0300] 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. 25D-25E. 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.
[0301] Referring now to FIGS. 26A-26B 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.
[0302] 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. The indicia may comprise a
series of lines. The lines may be graduated to indicate
predetermined angles or distances. The medial body 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.
[0303] 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.
[0304] 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 is
interconnected a medial 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.
[0305] In use, the alignment assembly 1700 may provide a first
reading before the alignment of the spine is altered, as shown in
FIG. 26A. 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.
26B.
[0306] Various apparatus formed by the system and method described
above and that may be used for a particular fixation related
surgery are depicted in FIGS. 27-33 and 40 which illustrate various
embodiments of patient-specific guides of the present invention.
The guides may be used for navigation of one or more of a cortical
bone trajectory, a pedicle screw trajectory, and other trajectories
in the spine of a patient. As will be appreciated by one of skill
in the art, the cortical bone trajectory, unlike the pedicle screw
trajectory, has a medial entry point and diverges superior and
laterally (or "up and away") when advancing anteriorly through the
pedicle. Additionally, the cortical bone trajectory allows for a
greater amount of fixation in cortical bone as opposed to pedicle
screw trajectories which achieve fixation mostly in cancellous
bone. Each of the guides illustrated in FIGS. 27-33 and 40 can
interface with any vertebra level or more than one vertebra level,
including without limitation the cervical, thoracic, lumbar, and
sacrum. Further, each of the guides include at least one cannulae.
The cannulae may include a bore adapted to guide one or more guide
wires, drill bits, taps, and screws. Optionally, a cannula may be
devoid of a bore. The cannula without a bore is adapted to provide
stability as other portions of the guide are used in a surgical
procedure. Additionally or alternatively, the guides may comprise
secondary and/or tertiary cannulae adapted to guide one or more of
the group comprising guide wires, drill bits, taps, screws,
couplings, and other instrumentation including without limitation
tools adapted to harvest bone grafts. The cannulae may be of a
variety of lengths. In one embodiment, at least a portion of the
proximal end of the cannulae and the guide is configured to extend
outside of the patient during a surgical procedure.
[0307] Any of the guides 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, and orientation. Accordingly, any of the guides described in
FIGS. 27-33 and 40 may include slots that are the same as, or
similar to, slots 20, 120, 320, 420, 520, 720, 820, or 1220. In one
embodiment, the slots are formed in place of bores of the
guides.
[0308] The guides may further comprise the ability to accept one or
more measurement devices for facilitating the surgeon/user in
identifying landmarks, surrounding boney anatomy, placement of
implanted devices, or for surgical planning Each of the guides may
be adapted for use with a specific vertebrae of the patient. The
guides may be formed according to the method of FIG. 2 or by any
other suitable method. Any of the guides of FIGS. 27-33 and 40 may
be used with, or include, tools, guides, wings, bodies, and
patient-contacting surfaces. In one embodiment, at least a portion
the guide is reusable.
[0309] Referring now to FIGS. 27-28 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.
[0310] Although the guide 1810 illustrated in FIGS. 27-28 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 may be formed as separate pieces that
are individually located with respect to the patient's anatomy and
then interconnected during the surgical procedure.
[0311] 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.
[0312] 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. For example, in one embodiment of
the present invention, the cannulae bore 1820 may include an
instrument contact surface, similar to the surface 122 of guide
110, that is associated with a feature of the tool, similar to the
protrusion 144 of tool 140, to control the depth or orientation of
insertion of the tool.
[0313] 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.
[0314] Thus, the cannulae may be adapted to prevent the instrument
or fixation device from advancing too far into the boney anatomy of
the patient. For example, in one embodiment of the present
invention, the bore 1820 of the cannulae 1816 may facilitate and
guide a drill bit or any other suitable instrument to drill and tap
a pilot hole in the cortical trajectory. Accordingly, in one
embodiment, the cannulae 1816 is manufactured out of, or the bore
1820 is lined with, a metal or metal alloy that is of sufficient
strength and brittleness that breaking and/or flaking is avoided.
Further, at least the interior surfaces of the bore 1820 may
withstand the effects of high-speed drilling without damaging the
bore 1820 or the cannulae 1816 or permitting material from the
cannulae 1816 to become deposited in the drilling site, as well as
facilitating re-use of the cannulae. The material of the cannulae
is also selected to withstand temperatures used to sterilize
surgical instruments.
[0315] After the pilot hole is created, the bore 1820 may further
guide insertion of a fixation device, such as a cortical screw
(such as fixture 734 described above), into the pilot hole. In
another embodiment of the present invention, the bore 1820 of the
cannulae 1816 may be adapted to receive one or more inserts 1854 of
varying lengths or a guide wire. The inserts 1854 may be sized with
external diameters for mating with the interior diameter of the
cannulae bore 1820. The insert 1854 may have an interior aperture
1856 running longitudinally through the insert for accommodating a
drill bit or tap, for example, of varying sizes. In practice, the
insert may facilitate and guide a drill bit for creating a pilot
hole for further insertion of a fixation device, such as a
screw.
[0316] As shown in FIG. 27E, the inserts 1854 may have a varying
length, and may be made longer or shorter depending on the geometry
of the guides 1810, the patient's anatomy, the purpose of the
insert, etc. For example, if a greater depth of a particular drill
is required, the insert 1854A may be shorter to accommodate further
penetration of the drill bit into the patient's vertebrae.
Likewise, the interior aperture 1856 of the insert 1854 may have
varying diameter depending on the precise tool or instrument that
is intended to be used with the insert. In this manner, a surgeon
may ensure that he or she is using the proper tool, such as a drill
or tap, with each of the inserts (which may further include one or
more indicia to indicate the location or specific use intended for
said insert) when performing a surgical procedure. For further
illustration of the principles described above see inserts 1854C
and 1854D which depict an insert with a 4.5 millimeter aperture
1856C diameter for placement of a tap instrument and a 1/8 inch
aperture diameter 1856D for use in connection with a 1/8 inch drill
bit, respectively.
[0317] The inserts 1854 described above may also include
patient-specific contacting surfaces 1858, for further matching the
insert 1854, in addition to the cannulae 1816, with the
patient-specific anatomy. This allows greater stability and
positioning of the insert 1854, and the cannulae 1816 with the
insert 1854 included, in the proper location. In addition, for
inserts 1854 used in connection with a drill bit or other vibrating
or oscillating tool, these patient-matching surfaces 1858 would
also prevent the distal end of the drill bit from "walking" or
moving on the surface of the vertebral body when creating the
initial pilot hole, thereby reducing the risk of incorrect
trajectory of a fixation device.
[0318] The insert 1854E may further comprise a key or notch 1860
about one surface of the generally cylindrical body of the insert,
which is configured to mate with a cutout or slot 1862 on the guide
sleeve 1816 of the guide 1810. In this manner, the proper
rotation/orientation of the insert 1854 is insured when guiding the
insert into the cannulae bore 1820 of the guide sleeve cannulae
1816.
[0319] The insert 1854 may comprise a surgical drilling sleeves
which may be used with a surgical guide according to an alternate
embodiment of the present disclosure. Drilling sleeves are
generally known in the art, however, the present embodiment relates
to custom drill sleeves 1854F, 1854G which may be placed through
one or more patient-matched inserts cannulae to provide contact
with the boney surface at the distal end 1858 of the drilling
sleeve. While custom drill sleeves 1854F, 1854G may be made of any
material, in a preferred embodiment the sleeves are manufactured
out of a metal or metal alloy that is of sufficient strength and
brittleness that breaking and/or flaking of the drill sleeve
material is avoided. Accordingly, the drill sleeves 1854F, 1854G
may withstand the effects of high-speed drilling without damaging
the sleeves 1854F, 1854G or permitting material from the sleeves to
become deposited in the drilling site, as well as re-use of the
drilling sleeves. The sleeves 1854F, 1854G must also withstand the
high temperatures encountered during sterilization. Another benefit
of metallic sleeves 1854F, 1854G is the ability to "trephine" or
machine with a cutting surface to permit the distal end 1858G of
the sleeve to "bite" into the bone and provide means for
fixation.
[0320] 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.
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.
[0321] 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. For
example, the contours and locations of the lower,
patient-contacting surfaces 1818, 1826 may be formed by use of data
set(s) converted from a MRI, CT, or other imaging scan of the
patient as described above in conjunction with FIG. 2. 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. Thus, the surfaces 1818, 1826 conform substantially to
a predetermined surface of the anatomical feature of the patient
where the cannulae 1816 and legs 1824 are to be located during the
surgical procedure. Further, with surfaces 1818, 1826, the cannulae
and legs would not conform substantially to a different surface of
the anatomical feature. In this manner, the surgeon can determine
if the guide 1810 is misaligned because the guide will not properly
seat on the predetermined surface of the anatomical feature. In one
embodiment, at least one of the surfaces 1818, 1826 is adapted to
contact a surface of the patient's anatomy previously altered
during a surgical procedure.
[0322] 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.
These patient-contacting surfaces 1818, 1826 help position the
guide 1810 and keep it in position in a predetermined position and
orientation. By protruding at least partially around different
portions of the patient's anatomy, the surfaces 1818, 1826
generally hook at least partially around the patient's anatomy.
Thus, the surfaces may contact at least two different planes formed
by distinct surfaces of the patient's anatomy.
[0323] 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.
[0324] 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. 33. 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.
[0325] Optionally, in one embodiment of the present invention,
illustrated in FIG. 27D, a cutting guide 10 may be interconnected
to the guide 1810A. The cutting guide 10 may be the same as, or
similar to, the cutting guides 10, 110 illustrated and described in
conjunction with FIGS. 3-6. The guide 10 generally includes a slot
20 adapted to guide a cutting tool. The slot 20 can have any shape
determined to guide cuts for a planned surgical procedure for a
particular patient. Further, the slot may comprise multiple
portions adapted to guide more than one different cut or more than
one instrument. The cutting slot 20 may be sized or shaped to
receive a particular cutting tool and to 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. The slot 20 may include stops adapted to limit or
control the depth of insertion of a cutting tool. Similar to other
slots described herein, the slot 20 may be specific to the
patient's anatomy. In one embodiment, the slot 20 continues through
a portion of the guide 1810A. Said another way, the slot 20 is
adapted to prevent contact by a tool or instrument positioned in
the slot with other portions of the guide.
[0326] The cutting guide 10 may be integrally formed with the guide
1810A. Alternatively, in another embodiment of the present
invention, the cutting guide 10 may be releasably interconnected to
the guide 1810A. In this manner, the cutting guide 10 may be added
to, or removed from, the guide 1810A during a surgical
procedure.
[0327] The cutting guide 10 may be interconnected to any portion of
the guide 1810A. In one embodiment, the cutting guide 10 is
interconnected to at least one of a leg 1824 and a cannula 1816 of
the guide 1810A. Optionally, the cutting guide 10 may be
interconnected to an arm 1814 or the medial body 1812. As will be
appreciated, the cutting guide 10 and slot 20 may have any
predetermined orientation with respect to the guide 1810A. Thus,
the cutting guide 10 or the slot 20 may be rotated in any
orientation other than the orientation illustrated in FIG. 27D.
[0328] Optionally, as illustrated in FIG. 27D, a cannula 1816A of
the guide may be devoid of a bore. The cannula 1816A has a shape
and size to provide stability as bore 1820 or cutting slot 20 are
used to guide instruments during a surgical procedure.
[0329] According to one embodiment, the guide 1810 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. The guide 1810 may take on other shapes, orientations,
thicknesses, etc. without deviating from the novel aspects of this
disclosure. Similarly, guide 1810 may be of any size and may
comprise extensions or handles to aid in grasping or manipulating
the guide 1810 as desired.
[0330] Referring now to FIGS. 29A-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 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 be 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 1912A, 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.
[0331] The cannulae 1916 are the same as or similar to the cannulae
1816 described above in conjunction with FIGS. 27-28. 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.
[0332] Thus, the cannulae 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. For example, in one
embodiment of the present invention, the bore 1920 of the cannulae
1916 may facilitate and guide a drill bit or any other suitable
instrument to drill and tap a pilot hole in the cortical
trajectory. After the pilot hole is created, the bore 1920 may
further guide insertion of a fixation device, such as a cortical
screw, into the pilot hole. In another embodiment of the present
invention, the bore 1920 may be adapted to receive one or more
inserts 1854 or guide wires in a manner similar to that illustrated
and described in conjunction with FIGS. 27-28, above.
[0333] 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. The surfaces 1918 of the cannulae
1916 are adapted to 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.
[0334] Although not illustrated in FIG. 29, the guide 1910 may
further comprise slots formed in the medial body 1912 or the
cannulae 1916. The slots may be the same as or similar to slots
1830. 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 above. Alternatively, the slots of guide
1910 may be adapted to receive one or more secondary or tertiary
cannulae as further described in conjunction with FIG. 33. The
guide 1910 may take on other shapes, orientations, thicknesses,
etc. without deviating from the novel aspects of this disclosure.
For example, the guide 1910 may include one or more legs similar to
legs 1824. The legs may extend from one or more of the medial body
1912 and the cannulae 1916. In one embodiment, at least one of the
cannulae include a lower leg portion 1824A. Similarly, guide 1910
may be of any size and may comprise extensions or handles to aid in
grasping or manipulating the guide 1910 as desired. In another
embodiment, the guide 1910 is adapted to receive a cutting guide 10
in a manner similar to guide 1810A illustrated in FIG. 27D.
[0335] Referring now to FIGS. 30A-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.
[0336] The cannulae 2016 is the same as or similar to the cannulae
described above in conjunction with FIGS. 27-28. Although only one
cannulae 2016 is illustrated in FIG. 30, it will be appreciated by
one of skill in the art that the guide 2010 may have any number of
cannulae. The cannulae 2016 includes a bore 2020 similar to bores
1820, 1920. The bore 2020 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. For example, in one embodiment of the
present invention, the bore 2020 of the cannulae 2016 may
facilitate and guide a drill bit or any other suitable instrument
to drill and tap a pilot hole in the cortical trajectory. After the
pilot hole is created, the bore 2020 may further guide insertion of
a fixation device, such as a cortical screw, into the pilot hole.
In another embodiment of the present invention, the bore 2020 may
be adapted to receive one or more inserts 1854 or guide wires in a
manner similar to that illustrated and described above.
[0337] Additionally or alternatively, the cannulae 2016 may include
a second bore. The second bore may be oriented in a different 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. For example, the slot may be similar to
slots 20, 120, 320, 420, 520, 720, 820, or 1220.
[0338] 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 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.
[0339] 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 cannulae 2016 may vary based on
patient specific anatomical features, a panned 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. In this manner, the guide 2010 may be aligned with the
patient's anatomy by a surgeon as planned with at least a portion
of a leg 2024 hooked around the patient's anatomy. 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.
[0340] In one embodiment of the present invention, the guide 2010
comprises three patient-matched legs 2024 adapted to create a
patient specific surface to align the cannulae 2016 in a
predetermined orientation. However, it will be appreciated by one
of skill in the art that the guide 2010 may include any number of
legs 2024.
[0341] 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 2024 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 or to
prevent obstruction of the surgeon's view during a surgical
procedure. 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. 27-28, to prevent
unintended or inadvertent contact between the guide 2010 and the
spinous process 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.
[0342] 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. 27-29. Additional patient specific contact
surfaces may also be formed on one or more other surface of the
legs 2024. Although not illustrated, the contact surfaces 2026 may
include protrusions adapted to one or more of: align the guide 2010
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 guide 2010 during a surgical
procedure, and displace soft tissue. In one embodiment, the contact
surfaces 2026 comprise relatively thin extensions. The contact
surfaces 2026 may contact or protrude around one or more of the
medial side of the inferior articular process, the lateral sides of
the lamina, the junction between the pars and the transverse
process, and the superior articular process. Optionally, at least
one of the contact surfaces 2026, or a portion of one of the legs,
may be adapted to contact a surface of the patient's anatomy that
has been altered during a surgical procedure.
[0343] Although not illustrated in FIG. 30, the guide 2010 may
further comprise slots formed in one or more of the cannulae 2016
and the legs 2024. The slots may be the same as or similar to slot
1830 and adapted to direct the path of a blade or other cutting
instrument in a manner similar to the slots described above.
Alternatively, the slots of guide 2010 may be adapted to receive
one or more secondary or tertiary cannulae as further described in
conjunction with FIG. 33. The guide 2010 may take on other shapes,
orientations, thicknesses, etc. without deviating from the novel
aspects of this disclosure. For example, in one embodiment of the
present invention, one leg 2024 may extend from another one of the
legs 2024. Similarly, guide 2010 may be of any size and may
comprise extensions or handles to aid in grasping or manipulating
the guide 2010 as desired. Further, the guide 2010 may be adapted
to interconnect to a frame, such as frame 330, 730, 1330. In
another embodiment, the guide 2010 may interconnect to a frame
prior to, or after, one or more of the guides 310, 710, 1302. In
this manner, the guide 2010 may be used in conjunction with one or
more of guides 310, 710, 1302 without placing additional fixtures
in the patient's anatomy.
[0344] Various guides as described herein may be provided to
facilitate or control a device (by way of example, a screw) entry
point, angular trajectory, height, and/or head orientation. This is
desirable particularly with placement of screws, as it permits the
surgeon/user to optimize spinal screw head alignment for subsequent
rod insertion across multiple boney landmarks. Additionally, by
controlling screw placement, a patient specific rod (described in
more detail below) may be designed and manufactured to either match
the pre-planned screw placement, or offer angular corrections in
order to optimize curvature of the spine. Additional benefits of
the various guides described herein include improving device
fixation, and/or preventing unwanted contact between devices and
patient anatomy (e.g. the patient's spinal cord). The further use
of methods described above, including the use of software
analytics, may further aid in determining screw placement and
orientation to achieve the ideal screw placement and/or rod shape.
For example, the use of various guides described herein to achieve
desired screw head placement and orientation in turn provides
improved alignment or a secondary device, such as a rod (described
in more detail hereinafter), with the screws heads. This benefit in
turn allows the surgeon/user to achieve optimal sagittal and/or
coronal alignment, which assists in rod placement and improves
correction of the patient's anatomy.
[0345] Referring now to FIGS. 31A-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.
[0346] 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.
[0347] Further, the surface 2113 may comprise two or more surfaces
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.
[0348] The cannulae 2116 is the same as or similar to the cannulae
described above in conjunction with FIGS. 27-30. It will be
appreciated by one of skill in the art 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
cannulae 2116 may terminate at a point substantially level with the
proximal surface of the guide. Additionally, the cannulae may have
any predetermined orientation with respect to the medial body 2112
of the guide 2110. In one embodiment, the cannulae 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 cannulae 2116A passes through a
lateral surface 2111 of the guide 2110.
[0349] 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 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 device 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. For example, in one
embodiment of the present invention, the bore 2120 of the cannulae
2116 may facilitate the placement of one or more of a guide wire,
securing element, and a pin in a cortical trajectory. In one
embodiment, the bore 2120 facilitates the placement of a guide wire
that may be used to guide drills, taps, and fixation devices such
as screws. The guide wire may be a K-wire known to those of skill
in the art. The guide 2110 may further be adapted to receive a
sleeve or an insert as described above.
[0350] During a surgical procedure, two or more guides 2110 may be
used. As illustrated in FIG. 31C, each guide may be positioned in
contact with different portions of the patient's anatomy. Further,
although not illustrated in FIG. 31, 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. 29 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.
[0351] Although not illustrated in FIG. 31, the guide 2110 may
further comprise slots formed in the medial body 2112. The slots
may be adapted to direct the path of a blade or other cutting
instrument in a manner similar to cutting slot as will be
appreciated by one of skill in the art. Alternatively, the slots of
guide 2110 may be adapted to receive one or more secondary 2140 or
tertiary cannulae 2150 as further described in conjunction with
FIG. 33. The guide 2110 may take on other shapes, orientations,
thicknesses, etc. without deviating from the novel aspects of this
disclosure. For example, the guide 2110 may include one or more
legs similar to legs 1824, 2024. Similarly, guide 2110 may be of
any size and may comprise extensions or handles to aid in grasping
or manipulating the guide 2110 as desired.
[0352] 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.
[0353] Referring now to FIGS. 32A-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.
[0354] The cannulae 2216 may be the same as or similar to the
cannulae described above in conjunction with FIGS. 27-31. Although
two cannulae 2216 are illustrated in FIG. 32, 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 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. Thus, the cannulae may be adapted to prevent
the instrument or fixation device from advancing too far into the
boney anatomy of the patient. For example, in one embodiment of the
present invention, the bore 2220 of the cannulae 2216 may
facilitate and guide a drill bit or any other suitable instrument
to drill and tap a pilot hole in the cortical trajectory. After the
pilot hole is created, the bore 2220 may further guide insertion of
a fixation device, such as a cortical screw, into the pilot hole.
In another embodiment of the present invention, the bore 2220 may
be adapted to receive one or more inserts of any variety of sizes.
The inserts, described above, may facilitate and guide a drill bit
or other tool, such as a tap.
[0355] Optionally, in one embodiment of the present invention, a
sleeve may be inserted into the bore 2220 of the cannulae 2216. The
sleeve may be similar to the sleeves 24 and inserts 1854 described
herein and may be comprised of the same or similar materials. The
sleeve may have an outer-diameter that is at least slightly greater
than the interior diameter of the cannulae bore. Accordingly, the
sleeve may be held in position within the bore by a press fit. In
one embodiment, the sleeve cannot be removed after insertion within
the bore. In this manner, it is possible to prevent miss-use of the
cannulae bore. Alternatively, the sleeve may be used to sequence
the use of tools and instruments associated with the cannulae. For
example, in one embodiment, the cannulae bore may have an internal
diameter or shape adapted to receive a first tool. A sleeve may
have a bore with an internal diameter or shape adapted to receive a
second tool. The sleeve bore may prevent insertion of the first
tool. In this manner, the sleeve will prevent use of the first tool
at an inappropriate or unintended time. Further, when the sleeve
has an outer diameter that prevents removal of the sleeve from the
cannulae bore, the sleeve prevents use of the first tool after the
sleeve bore has been used to guide the second tool.
[0356] In one embodiment, the sleeve is adapted for use with an
instrument. In another embodiment, the interior diameter of the
sleeve bore is substantially equal to the outer diameter of the
sleeve. Thus, the sleeve may be very thin. In still another
embodiment, the sleeve bore may include keys, tracks, or
protrusions adapted to guide a feature on an exterior surface of an
instrument received by the cannulae. The sleeves may be sized to
fit within the bore of an cannulae described herein.
[0357] In one embodiment of the present invention, the cannulae
2216 have a length such that the distal or terminal ends 2218 of
the cannulae 2216 do not contact the patient's anatomy. Said
another way, the terminal ends 2218 of the cannulae 2216 are
adapted to float above predetermined portions of the patient's
anatomy. In another embodiment of the present invention, one or
more of the cannulae 2216 have a length such that the terminal end
2218 of the cannulae 2216 intentionally contacts one or more of the
lamina, pars, the transverse process, the superior articular
process of the patient, and a different anatomical feature of the
patient. Continuing this example, patient-specific contact surfaces
may be formed on the terminal end 2218 of the cannulae 2216 as well
as other surface of the cannulae. Thus, the terminal ends 2218 of
the cannulae 2216 and other surfaces may optionally provide still
other guide surfaces to align and/or stabilize the guide 2210 in a
predetermined orientation during a surgical procedure.
[0358] The legs 2224 of the guide 2210 may each comprise a
different length. Additionally, the position and alignment of the
legs 2224 with respect to the cannulae 2216 may vary based on
patient specific anatomical features or the surgeon's preference.
The legs 2224 are adapted to contact predetermined portions of the
patient's anatomy. In one embodiment of the present invention, the
guide 2210 comprises two patient-matched legs 2224 adapted to
create a patient specific surface to align the cannulae 2216 in a
predetermined orientation. However, it will be appreciated by one
of skill in the art that the guide 2210 may include any number of
legs 2224.
[0359] Although illustrated in FIG. 32 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. 27-28, 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.
29) adapted to create other patient specific contact surfaces to
one or more of align and stabilize the guide 2210.
[0360] 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. 27-28.
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.
[0361] The second legs or bridge 2230 is adapted to contact one or
more of the spinous process and the lamina of the patient. In the
embodiment of the present invention illustrated in FIG. 32, the
bridge 2230 extends medially from the cannulae 2216. In 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. The longitudinal cavity may be formed by use
of data set(s) converted from an MRI or CT scan of the patient as
described above in conjunction with FIG. 2. 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 of a particular vertebral body 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 includes 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.
[0362] The guide 2210 may also include extensions adapted to hook
at least partially around, or too, 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.
[0363] Although not illustrated in FIG. 32, the guide 2210 may
further comprise slots formed in one or more of the medial body
2212, the cannulae 2216, and the legs 2224. The slots may be the
same as or similar to slot 1830 and adapted to direct the path of a
blade or other cutting instrument in a manner similar to cutting
slot described above. Alternatively, the slots of guide 2210 may be
adapted to receive one or more secondary or tertiary cannulae 2240,
2250 as further described in conjunction with FIG. 33. 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.
[0364] The guide 2210 may take on other shapes, orientations,
thicknesses, etc. without deviating from the novel aspects of this
disclosure. For example, in one embodiment of the present
invention, one leg 2224 extends from another one of the legs 2224.
In another embodiment, at least one of the legs 2224 extends from
the medial body 2212. Similarly, guide 2210 may be of any size and
may comprise extensions or handles to aid in grasping or
manipulating the guide 2210 as desired.
[0365] Referring now to FIG. 33, 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. 27-28.
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.
[0366] 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 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.
[0367] 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., C1-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.
27-32. Accordingly, the bore 1820 can guide one or more of a guide
wire, a drill bits, 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.
[0368] 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.
[0369] The ends of the cannulae 2340, 2350 may include patient
specific contact surfaces as previously described in conjunction
with FIGS. 27-32. Additionally, the angle and orientation of each
cannulae 2340, 2350 can be varied to match the anatomy of the
patient. The tertiary cannulae 2350 may be interconnected to a
secondary cannulae 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.
[0370] With respect to the embodiments shown and described in
relation to FIGS. 35-39, a variety of mechanical characteristics
may be incorporated into coupling devices and rods without
departing from the spirit of the disclosure made herein. Applicant
incorporates by reference U.S. Patent Publication No. 2009/0105760
in its entirety, which is co-pending and names Dr. George Frey as
the sole inventor, for the purpose of further supplementing the
disclosure and providing additional support for various mechanical
characteristics capable of being employed in the coupling device.
In addition, methods of forming and shaping rods used in surgical
procedures are disclosed in U.S. Pat. No. 9,044,285, U.S. Pat. No.
8,721,651, U.S. Pat. No. 8,607,603, U.S. Pat. No. 8,549,888, U.S.
Pat. No. 8,540,719, U.S. Pat. No. 8,298,242, U.S. Pat. No.
7,957,831, U.S. Pat. No. 7,454,939, U.S. Pat. No. 6,644,087, U.S.
Pat. No. 6,221,077, U.S. Pat. No. 6,035,691, U.S. Pat. No.
6,006,581, U.S. Pat. No. 5,490,409, U.S. Pat. Pub. No.
2015/0127053, U.S. Pat. Pub. No. 2015/0047410, U.S. Pat. Pub. No.
2014/0137618, U.S. Pat. Pub. No. 2013/0110174, U.S. Pat. Pub. No.
2008/0086127, U.S. Pat. Pub. No. 2007/0227216, U.S. Pat. Pub. No.
2005/0262911, U.S. Pat. Pub. No. 2004/0243481, U.S. Pat. Pub. No.
2004/0144149, WIPO Pub. No. WO 2014/143762, WIPO Pub. No. WO
2014/088801, and WIPO Pub. No. WO 2009/035358 which are each
incorporated by reference in their entirety to further supplement
and provide additional support to the present disclosure.
[0371] Referring now to FIGS. 35-39, embodiments of
patient-specific rods and methods of forming and shaping the rods
are described. More specifically, locations of fixation devices
(e.g. pedicle screws, cortical bone screws, spinal hooks) to be
used in a surgical procedure is determined. The locations of the
fixation devices includes, but is not limited to, entry point of
each fixation device, the trajectory and orientation of each
fixation device, and the size and type of the fixation devices. The
trajectory may be determined from the use of scanning equipment
described above, and selected based on optimal patient anatomy,
bone density, etc. The diameter, size, and height of the rod or
other implant is considered when determining the locations of the
fixation devices. The entry points and locations of each fixation
device are mapped in three dimensions in reference to a given
origin. Screw head location may be with or without correction of
the patient's abnormality.
[0372] The map of the fixation devices is used to presurgically
plan the contours of a rod. The rod planning can be conducted
manually by a surgeon or technician or automatically conducted by a
software algorithm that uses information such as angles, lengths,
radii, etc. to generate the optimal correction for a patient. The
rod planning may also consider a surgeon's preferred "textbook" or
preferred correction as well as physical limitations of the
patient's anatomy (e.g. resistance from soft tissue).
[0373] The rods 2420 may have any size or shape for any planned
surgical procedure. Rods of a different shapes, sizes, and
materials may be used together in one surgical procedure. In one
embodiment, at least one rod has a generally cylindrical shape. In
another embodiment, a rod has at least one generally planar
surface. In yet another embodiment, a rod 2420 has a
cross-sectional configuration that is one of: V-shaped, W-shaped,
polygonal-shaped, and tapered. In one embodiment, the rod is a
spinal fusion rod. However, one of skill in the art will appreciate
that the rods and methods of forming them described herein may be
used in conjunctions with other surgical procedures.
[0374] The map of the fixation devices is used to form a rod for
use in the surgical procedure. In one embodiment of the present
invention, a patient specific rod that is pre-bent is manufactured.
The patient specific rod has a shape substantially aligning with
the head or tulip of each screw trajectory included in the map of
the fixation devices. The patient specific rod can be manufactured
or formed by any suitable method, including by a 3D printer (SLA or
SLS as a template, out of metal, polyetheretherketone (PEEK), or
any other material suitable for use in an implant for a patient),
manufactured using a rod bending machine (out of metal to be used
as template or implant), machined, or manufactured using an
equivalent process. In one embodiment of the present invention, the
patient specific rod is manufactured using the method described
above in conjunction with FIG. 2. In another embodiment, the
patient specific rod is designed using a computer aided design
(CAD) process.
[0375] The patient specific rod has a shape that substantially
aligns with the planned locations and orientations of screw heads
intended to interconnect the rod to the patient's anatomy. The
patient specific rod can be planned to be produced with bends or
contours in three dimensions to match a planned contour of the
patient's spine. In one embodiment the patient specific rod only
matches the patient's pre-operative anatomy and the planned screw
locations. This allows the surgeon to induce any desired correction
by making additional bends to the baseline (pre-operative)
curvature of the rod. In another embodiment of the present
invention, the patient specific rod substantially matches the
planned screw locations and also accounts for preoperatively
planned correction of the patient's deformity (accounting, for
example, for sagittal and/or coronal alignment of the patient's
spine). Optionally, the surgeon may manually reshape the patient
specific rod to generate any additional desired correction to the
patient's spine.
[0376] In another embodiment, the map of the fixation devices is
used to manufacture a rod template as described above in
conjunction with FIG. 2. The rod template has a shape substantially
matching the planned locations and orientations of the screw heads.
A generic rod is then manually re-shaped by the operator to
substantially conform to the rod template and form a patient
specific rod. In one embodiment, the rod template includes a recess
adapted to receive the generic rod. In another embodiment, the rod
template includes a number of protrusions adapted to receive the
generic rod which is then bent to align with the planned screw
locations. In one embodiment, the generic rod has no
patient-specific contours before being manually re-shaped.
[0377] Referring now to FIGS. 34A-34B, a patient-specific bone
model 2402 of one embodiment of the present invention is used to
form a rod 2420 prior to, or during, a surgical procedure. The
model 2402 is generated from patient imaging data (CT, MRI, etc.)
and converted to 3D CAD or FEM models. The data for the model may
also be captured by an optical system.
[0378] Here, the underlying anatomy is a portion of the patient's
spine. Although only three vertebrae V1-V3 are included, the model
2402 may include any number of the patient's vertebrae. Further,
one of skill in the art will appreciate that the model 2402 may be
made to represent any predetermined portion of the patient's
anatomy. The model may include a reproduction of the deformity
associated with these levels of the patient's spine.
[0379] The model 2402 provides a user with both a visual and
tactile representation of the patient's anatomy for creating a
patient-specific rod, including one or more predetermined screw
trajectories. During design of the model, cylindrical members 2404
may be used with the model 2402 to represent planned screw
trajectories. The user may manipulate the members 2404 during the
design of the model to change the location and trajectory of each
screw.
[0380] The modeling of predetermined screw trajectories assists in
the orientation and placement of the rod. Further, the model 2402
may help the surgeon determine the shape and length of the rod
necessary to correct the patient's deformity as well as different
positions and alternate arrangement of the planned screws. By using
the model 2402, a user may also identify changes to the shape of
the rod necessary to correct the patient's anatomy.
[0381] Planned screw locations and trajectories may be simulated by
bores 2408 in the model 2402. Each screw may have a different
planned trajectory. Although the bores 2408 are illustrated with a
generally cylindrical shape, it will be appreciated by one of skill
in the art that the bores 2408 may have any predetermined shape.
Further, the bores 2408 may have a predetermined depth and
diameter. In one embodiment, each bore has a unique cross-section.
In another embodiment, the screw trajectories are designed using
generic cylinders in the CAD system.
[0382] After the screw trajectories and locations are determined,
the model 2402 is generated. In one embodiment of the present
invention, the model is formed using any 3D printing process or
rapid prototyping process as will be appreciated by one of skill in
the art. In another embodiment, the model 2402 may be formed as
describe above in conjunction with FIG. 2. In still another
embodiment, the vertebra V1-V3 of the model 2402 are flexibly
interconnected to enable movement of the model 2402.
[0383] Referring now to FIGS. 34C-34D, one or more pegs 2440,
described in more detail below in conjunction with FIG. 36, may be
positioned in the bores of the model 2402. The positions of the
pegs 2440 and the orientation of the peg head 2444 may be altered
to adjust the planned screw orientation. For example, the body of
one or more of the pegs 2440 may be advanced or withdrawn at least
partially in the bore 2408 to alter the location of the peg head
2444. Alternatively, the pegs 2440 or the heads 2444 may be rotated
or pivoted with respect to the model 2402. Further, a peg with a
different size body may be used to change the planned shape of the
rod. Optionally, in one embodiment of the present invention, the
pegs 2440 may be integrally formed with the bone model 2402 with
the heads 2444 in a predetermined position.
[0384] Referring now to FIGS. 34E-34F, the model 2402 with the pegs
2440 is used as a template by the surgeon (or other operator) to
presurgically bend rods 2420 to the planned shape. Placing the rod
2420 on the model 2402 as illustrated in FIGS. 34E-34F permits the
surgeon to determine the length and orientation (including
curvature) of the fixation rod required to correct the deformity or
otherwise treat the patient. The model 2402 may also assist the
user in other aspects of the surgical procedure. For instance,
placing the rod on the model allows the surgeon to visualize the
difference in height of each level of the patient's spine and
differences from one level to the next and also allow the user to
visualize whether the rod is misaligned or requires modification to
correct the patient's deformity. For example, the surgeon may
identify unwanted contact between the patient's anatomy and either
the screws or the rod.
[0385] The surgeon may also receive tactile feedback when placing
the rod on the model 2402, such as a clip or snap when the rod is
properly aligned with, and received by, the pegs. As described
above, the model 2402 may be flexible to reproduce movement of the
patient's spine. When the rod is placed on the model, the surgeon
can move the model to determine if rod and screws optimally correct
the patient's deformity.
[0386] The surgeon can use the model 2402 to preoperatively
generate desired correction in the rod for either a generic rod or
a patient specific rod. For example, as previously described, a
generic rod may be bent by the surgeon until it fits substantially
in the planned screw locations represented by the heads 2444 of the
pegs 2440. The generic rod is bent by any suitable method as will
be appreciated by one of skill in the art. In one embodiment, after
the generic rod 2420 is bent it is retained within the recesses
2446 of the heads 2444. Thus, when adjusted to the appropriate
shape, the rod may "click" into place and can be locked once the
user has finished their adjustments to achieve optimal fit and
correction of the patient's anatomy.
[0387] Alternatively, the rod may be a patient specific rod
manufactured with bends pre-formed to substantially match the shape
of the rod to the planned screw locations. For example, as
illustrated in FIGS. 34E-34F, the patient specific rod 2420 may
align with the planned screw locations without further adjustment
by the surgeon. However, after placing the patient specific rod on
the model 2402 with the pegs, the surgeon may determine that the
shape of the rod should be further adjusted. This can be
accomplished by removing the rod 2420 from the model 2402 and
bending the rod by any method. In one embodiment, the rod may be
bent manually by the surgeon's hands. In another embodiment, a tool
may be used to bend the rod. The surgeon may manipulate the rod
2420 and move the vertebrae V1-V3 of the model 2402 to visualize
the correction in the model itself until the desired alignment of
the vertebrae is achieved. The rod 2420 may then be used in a
surgical procedure.
[0388] Referring now to FIG. 35A, a configurable template 2502
according to an embodiment of the present invention is illustrated.
The template 2502 includes peg holders 2508 adapted to retain pegs
2440 is predetermined positions. The pegs 2440 represent the
positions and orientations of fixation implants, such as screws, in
the map of fixation devices planned to be used in a surgical
procedure. The location, orientation, and height of each peg may be
adjusted using the template 2502. The pegs 2440 can have various
lengths and configurations in order to account for the height and
orientation of each planned screw. The heads 2444 or entire pegs
2440 may be rotated to simulate planned placement of spinal
fixation devices.
[0389] In one embodiment peg holders 2508 protrude from the surface
of the template 2502 and the pegs 2440 fit onto the holders. In
another embodiment, the peg holders 2508 comprise a plurality of
voids sized to receive at least a portion of a peg. In one
embodiment, the holders 2508 are arranged in a grid of rows and
columns. In one embodiment, the template 2502 is a generic device,
such as a peg-board. In another embodiment, the pegs may be
slidingly retained by the template. Thus, the position and
alignment of one or more of the pegs may be altered by the user. In
still another embodiment, the template may be modeled within a CAD
system. The coordinates and sizes of the pegs may then be modeled
in the CAD system. When an appropriate amount of correction is
provided by a rod by the pegs, the data related to the pegs are
saved in the CAD system. The pegs and rod, or rod template, may
then be manufactured as described below.
[0390] Referring now to FIG. 35B, pegs 2440 are arranged in
predetermined positions on the template 2502 according to the
planned surgical positions of the screws. A sufficient number of
pegs necessary to provide inflection points of the rod in
three-dimensional space may be used with the template 2502. In one
embodiment, arranging the pegs on the template comprises preparing
a map to identify the location and trajectory of each screw. The
map is used to determine entry points of the planned trajectory of
each of the screws. The entry points are mapped in three dimensions
in reference to a given origin. The coordinates and height of the
entry points is used to orient the pegs on the template 2502 to
substantially duplicate the presurgically planned screw trajectory
for a specific patient.
[0391] In one embodiment, the screw map is created using a CAD or
FEM program or other planning tool. The location of the entry
points can then be exported as a CAD file and re-mapped into a
second CAD file containing the template 2502. By referencing the
origin of the entry points to a given location within the template
file, the entry point locations can be oriented such they have a
known location in relation to the template 2502.
[0392] In another embodiment, the template 2502 and pegs 2440 are
manufactured after the screw map with the screw locations and
orientations has been created. The template 2502 is then
manufactured with a number of peg holders 2508 in the positions of
the planned screw locations. The number of peg holders may be equal
to the number of screws planned to be used in the surgical
procedure. Each peg holder 2508 may have a unique cross-sectional
profile corresponding to the cross-sectional profile of a
corresponding portion of the body of one of the pegs 2440. Further,
each peg may have a unique length and head orientation. In one
embodiment, the length and head orientation of the pegs is
determined from the screw map. In this manner, each peg 2440 may be
placed in the correct location and orientation.
[0393] When the pegs are in the predetermined arrangement on the
template 2502, the template can be used to adjust a rod 2420 as
illustrated in FIGS. 35C-35E. A surgeon or other user can then
change the orientation or location of one or more of the pegs 2440.
The surgeon may then bend the rod 2420 to correspond to the new
positions of the pegs 2440 to change the shape of the rod 2420.
Each rod 2420A, 2420B may have unique contours and a different
length and size.
[0394] The rod 2420 can be a generic rod, described above, that is
bent to substantially align with the heads 2444 of the pegs. When
the generic rod is substantially aligned with the heads, it will
fit with the planned screw trajectories without further correction.
However, the surgeon can change the shape of the rod 2420, for
example, to alter the amount of correction provided by the rod.
[0395] Alternatively, the template 2502 can be used to modify the
shape of a pre-manufactured patient specific rod. When the pegs are
arranged on the template according to the screw map, the patient
specific rod will substantially align with the heads of the pegs.
In one embodiment of the present invention, the patient specific
rod is retained in recesses 2446 of the heads 2444. Thus, the
patient specific rod will fit with the planned screw trajectories
without manual bending by the surgeon. However, as described above,
the surgeon may optionally change the shape of the patient specific
rod as necessary, desired, or for any other reason.
[0396] Referring now to FIG. 36, pegs 2440 of embodiments of the
present invention are illustrated. The pegs are used with used in
conjunction with the models 2402 and templates 2502 of the present
invention to simulate surgical screws adapted to hold the rods
2420. The pegs generally include a body 2448 and a head 2444.
[0397] The body 2448 has a size and shape to be engaged by a bore
2408 of the model 2402 or a holder 2508 of the template 2502. In
one embodiment, the body 2448 has a size selected to frictionally
engage the interior surface of a bore 2408 or a holder 2508 to
retain the peg in a selected orientation with respect to the model
2402 or the template 2502. In another embodiment, the shape of the
body 2448 is selected to prevent unintended rotation or movement of
the peg in relation to the model 2402 or the template 2502. In one
embodiment, the cross-sectional shape of the body is one of round,
triangular, and square.
[0398] The head 2444 is adapted to receive a rod 2420. In one
embodiment, the head includes a receiver or recess 2446 adapted to
releasably interconnect the rod 2420 to the peg. In one embodiment,
the recess 2446 has a generally U-shaped cross-section. However, it
will be appreciated by one of skill in the art that the recess may
have any other cross-sectional configuration, including, for
example, V-shaped, W-shaped, polygonal-shaped, or tapered.
[0399] The head 2444 may be stationary or movably interconnected to
the body 2448. For example, in one embodiment, the peg 2440A
includes a head and body that are formed as one integral piece.
[0400] In another embodiment, the peg 2440B includes a head 2444
and body 2448 that are formed separately. The head and body may be
joined by suitable techniques known in the art. In one embodiment,
the pegs 2440B include an extension 2550 of the head 2444 for
insertion into complementary receiver 2552 of the body 2448.
Alternatively, one or more tabs may be formed on one of the head or
the body and complementary slots on the other of the head and body
for receiving the tabs. Bodies 2448 of a variety of lengths may
interchangeably be used with the head to adjust the length of the
peg 2440B. Further, the orientation of the recess 2446 may be
modified by rotating one of the head and the body.
[0401] In yet another embodiment, the peg 2440C includes a head
2444 pivotally interconnected to the body 2448. Further, the head
2444 can be moved around one or more axis with respect to the body.
Accordingly, the head may be capable of monoaxial or polyaxial
movement.
[0402] The pegs may be made of any desired material, including
plastic, metal, and wood and combinations thereof. In one
embodiment, a peg 2440 is manufactured by a 3D printing process. In
another embodiment, a peg 2440 is machined.
[0403] Referring now to FIGS. 37A-37B, an embodiment of a template
2602 of a surgical tool, instrument or device is provided. The
template 2602 may be customized or contoured as described above in
conjunction with FIG. 2 to conform to a specific patient's anatomy.
In certain embodiments, the template 2602 may provide a surgeon
with a particular dimension, shape, orientation, etc. for a device
such as a rod 2420.
[0404] A map or plan of the locations and orientations of fixation
devices that are planned to be used in a surgical procedure is
created, as described above. The map includes planned screw
trajectories in relation to a specific portion of the patient's
anatomy. Patient specific bone models, the same as or similar to
model 2402, may be used to create the screw map. Optionally, in
another embodiment of the present invention, a template 2502 and
pegs 2440 may be used to create the screw map. In another
embodiment, the screw map is created using a CAD program or other
planning tool.
[0405] The map plan is used to create a patient-specific rod. In
one embodiment, the rod 2420 is machined using the screw map. In
another embodiment, the CAD program uses the screw map to model the
rod by connecting each individual planned screw head. This
generates a digital model of a rod that will fit into the planned
screw locations. The CAD program can then create a template 2602
that includes a negative 2608 of the rod. In one embodiment, the
shape of the negative 2608 does not include correction of the
deformity of the patient. In another embodiment, the shape of the
negative 2608 includes at least some correction of the patient's
deformity.
[0406] The template 2602 and the negative are manufactured using
any suitable manufacturing method. In one embodiment, the template
is manufactured using any 3D printing system as described above or
developed in the future.
[0407] The surgeon may use this negative template 2602 to manually
generate three-dimensional patient-specific contours in a generic
rod 2420. Once the rod fits in the negative 2608 of the template,
it will fit with the planned screw trajectories. Additional
correction can be added by the surgeon as necessary or desired.
Alternatively, a patient specific rod may be formed with contours
that substantially fit in the negative 2608 without additional
shaping by the surgeon. The surgeon may then bend the
patient-specific rod to alter the shape of the rod. For example,
the surgeon may add additional correction to the rod, or change the
amount of correction in the rod to correct the patient's
deformity.
[0408] The template 2602 may optionally include indicia to indicate
a position of use, portions of the patient's anatomy, direction,
orientation, or the purpose of the rod. The embodiment of the
template illustrated in FIG. 37 includes indicia to indicate an
alignment of the template. In one embodiment, indicia 2610A
indicates a posterior direction and an anterior direction. The
template may also include indicia 2610B to identify portions of the
patient's anatomy, such as a level of the patient's spine. For
example, indicia 2610B is associated with the L5 vertebrae and
indicia 2610C is associated with the T3 vertebrae. As will be
appreciated by one of skill in the art, any number and type of
indicia can be provided associated with different portions of the
patient's anatomy.
[0409] Referring now to FIGS. 38A-38B, an example of a rod 2420
formed according to one embodiment of the present invention is
illustrated in relation to a patient's spine. The screws used to
interconnect the rod to the patient's spine have been removed for
clarity. After the rod is shaped as described above, the surgeon
may further adjust the shape of the rod during a surgical
procedure.
[0410] Referring now to FIG. 39, an embodiment of a method 2704 of
configuring a rod 2420 for use in a surgical procedure is
illustrated. A general order for the steps of the method 2704 is
shown in FIG. 39. The method 2704 can include more or fewer steps
or can arrange the order of the steps differently than those shown
in FIG. 39. Hereinafter, the method 2704 shall be explained with
reference to the embodiments of the present invention described
above in conjunction with FIGS. 34-38.
[0411] Generally, the method 2704 starts 2708 by obtaining data of
the patient's anatomy. The data can be obtained from one or more of
a radiographic imaging machine, a fluoroscopy, an ultrasonic
machine, or a nuclear medicine scanning device. Once captured, the
data is converted into a digital model at step 2712. The digital
model can be produced using known software tools and used in a CAD
program. At step 2716, the size, location and orientation of
fixtures, such as screws, is planned using the digital model.
Optionally, at step 2720, a model 2402, a configurable template
2502, or template 2602 with a rod negative may be produced as
described above in conjunction with FIGS. 34-37.
[0412] A rod 2420 is produced at step 2724. The rod may be a
patient-specific rod with pre-formed bends or contours produced
using the planned screw placement. Alternatively, a
patient-specific rod can be produced using additional data obtained
using one of the models or templates from step 2720. The rod may
also be a generic rod without a patient specific shape. Optionally,
in step 2728, a generic rod 2420 may be reshaped to fit the model
2402, configurable template 2502, or negative template 2602.
[0413] At step 2732 the surgeon determines if additional shaping or
correction of the rod is necessary. For example, the surgeon may
use one or more of the model 2402 or templates 2502-2602 to adjust
the shape of either a pre-formed patient-specific rod or a generic
rod. The shape may be adjusted to change the amount of correction
of the patient's deformity provided by the rod, to avoid a portion
of the patient's anatomy, or due to the surgeon's preferred
correction or technique. If additional correction is necessary or
desired, the method proceeds YES to step 2736 and the rod is
reshaped. If no additional correction is necessary or required, the
method proceeds NO to step 2740 and the rod ready for use in a
surgical procedure. Optionally, at step 2744, the rod may be used
in a surgical procedure.
[0414] Referring now to FIGS. 40A-B, yet another patient-specific
guide 2810 of an embodiment of the present invention is
illustrated. The guide 2810 is similar to guide 1810 described
above and comprises similar features. In one embodiment, guide 2810
comprises a medial body 2812 and at least one cannulae 2816.
[0415] The guide may comprise individual pieces adapted to be
assembled by a surgeon before, or during, a surgical procedure.
Accordingly, in one embodiment, the medial body 2812 is formed as
two separate portions 2812A, 2812B. The portions 2812A, 2812B may
be individually positioned in contact with a predetermined feature
of the patient's anatomy. Further, the portions are adapted to be
interconnected at joint 2815 in a manner similar to guide 1910
described above. In one embodiment, one portion of the medial body
2812 includes a coupling adapted to releasably interconnect the
individual portions 2812A, 2812B of the guide 2810 together. The
coupling may be the same as, or similar to, coupling 1913.
Accordingly, in one embodiment, the two portions 2812A, 2812B of
the guide may be interconnected by positioning the coupling in a
corresponding void in the other portion of the medial body. The
coupling may be held in the void by friction. Additionally or
alternatively, a biasing force may be provided to retain the
coupling 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 2812A, 2812B 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 2812A, 2812B may be
interconnected by any other suitable means. Optionally, in another
embodiment of the present invention, the guide 2810 is formed as
one integral piece.
[0416] The guide 2810 may include features adapted to be grasped or
manipulated by a surgeon. In one embodiment, protrusions 2829 are
formed on a portion of the guide 2810. The protrusions may be of
any shape or size selected facilitate grasping of the guide in a
surgical environment. In one embodiment, the protrusions 2829 are
formed on a portion of the medial body 2812. The protrusions may
comprise ridges or bumps. In one embodiment, the protrusions
comprise three generally parallel ridges formed on opposing sides
of each portion 2812A, 2812B of the medial body.
[0417] The cannula 2816 is the same as, or similar to, the cannulae
1816 described above in conjunction with FIGS. 27-28. In one
embodiment, the guide 2810 comprises two cannulae 2816. However, it
will be appreciated that the guide may include any number of
cannulae. Each cannulae 2816 may have a generally cylindrical
shape. Other shapes of the cannulae are contemplated. The cannulae
2816 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.
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 2810, and the type of tool or
fixation device associated with the cannulae 2816.
[0418] At least one of the cannulae 2816 may include a bore 2820
similar to bore 1820. The bore 2820 comprises a predetermined
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.
The bore diameter may also prevent the instrument or device from
advancing into the cannulae 2816 beyond a predetermined distance,
thereby providing a hard stop. Additionally, the bore 2820 may have
a shape adapted to align the tool or fixation device in a
predetermined orientation of use. Thus, the cannulae 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.
For example, in one embodiment of the present invention, the bore
2820 of the cannulae 2816 may facilitate and guide a drill bit or
any other suitable instrument to drill and tap a pilot hole in the
cortical trajectory. After the pilot hole is created, the bore 2820
may further guide insertion of a fixation device, such as a
cortical screw, into the pilot hole. In another embodiment of the
present invention, the bore 2820 may be adapted to receive one or
more inserts 1854 or guide wires in a manner similar to that
illustrated and described in conjunction with FIGS. 27-28,
above.
[0419] In one embodiment, the bore 2820 is oriented in a cortical
bone trajectory. In another embodiment comprising a bore 2820 in
each of the cannulae 2816, the bores may be oriented to target
different portions of the patient's anatomy. In still another
embodiment, each bore 2820 of two or more cannulae is oriented in a
cortical bone trajectory.
[0420] The cannulae 2816 may optionally include extensions 2819.
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 at least partially around
one of the pars and the superior articular process. The extensions
may have 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 have a shape that wraps
around a portion of the exterior of the cannulae. The extensions
2819 may also project at least partially beyond the distal end of
the cannulae.
[0421] The guide 2810 may take on other shapes, orientations,
thicknesses, etc. without deviating from the novel aspects of this
disclosure. For example, the guide 2810 may include one or more
legs 2824 similar to legs 1824. The legs may extend from one or
more of the medial body 2812 and the cannulae 2816.
[0422] Additionally or alternatively, patient-specific contact
surfaces may be formed on any patient-contacting surfaces 2818 of
the cannulae 2816, including the extensions 2819, the legs 2814,
and/or the contacting surfaces 2826 of the medial body 2812. The
surfaces 2818, 2826 provide a plurality of patient-specific
contours for matching with a plurality of anatomical features, as
described in greater detail above. The surfaces 2826 of the medial
body 2812 may contact at least a portion of the spinous
process.
[0423] The surfaces 2818 of the cannulae 2816 and the surfaces 2818
of the extensions 2819 and legs 2824 (when present) are adapted to
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 2818, 2826 help position the guide 2810 and keep it in
position in a predetermined position and orientation.
[0424] Although not illustrated in FIG. 40, 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 above.
Alternatively, the slots of guide 2810 may be adapted to receive
one or more secondary 2840 or tertiary cannulae 2850 as further
described in conjunction with FIG. 33. In another embodiment, the
guide 2810 is adapted to receive a cutting guide 10 in a manner
similar to guide 1810A illustrated in FIG. 27D. 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.
[0425] Although the devices described above have been illustrated
for use with certain guide screws and/or instruments, it is
expressly understood that the devices may be used with a variety of
other implantable and non-implantable apparatus, including by way
of example, medial-to-laterally placed transpedicular screws
(commonly referred to as cortical bone trajectory screws). Other
screws and instruments may be used with the surgical devices
described above without departing from the spirit of the
disclosure, and are considered to be within the scope of the
appended claims.
[0426] With respect to the embodiments described above, it is
expressly understood that such embodiments may be incorporated for
use in practicing the novel methods described herein. In certain
embodiments, those methods may comprise greater or fewer steps than
as described above. By way of example, but not limitation, one step
for use with the various embodiments described above may comprise
the use of various technologies for capturing a patient's unique
morphology, and subsequently mapping and/or planning the
fabrication of a device comprising one or more "patient matched"
surfaces or features for complementing that unique morphology.
Further, such devices may be further optimized with respect to the
unique data associated with the patient, such that the device may
be matched with specific devices for use during the surgical
procedure, or oriented around the patient's own anatomy to achieve,
for example, one or more desired insertional trajectories (which
may be verified in a pre-operative setting). Variations on this
step, and the inclusion or exclusion of additional steps described
herein are expressly contemplated by the present disclosure.
[0427] While various embodiments of the present disclosure have
been described in detail, it is apparent that modifications and
alterations of those embodiments will occur to those skilled in the
art. However, it is to be expressly understood that such
modifications and alterations are within the scope and spirit of
the present disclosure, as set forth in the following claims. For
further illustration, the information and materials supplied with
the provisional and non-provisional patent applications from which
this application claims priority are expressly made a part of this
disclosure and incorporated by reference herein in their
entirety.
[0428] Additionally, although the fusion cages of the present
invention are particularly well-suited for implantation into the
spinal column between two target vertebrae, and although much of
the discussion of the present invention is directed toward their
use in spinal applications, advantages offered by embodiments of
the present invention may also be realized by implantation at other
locations within a patient where the fusion of two or more bony
structures may be desired. As one of skill in the art will
appreciate, the present invention has applications in the general
field of skeletal repair and treatment, with particular application
to the treatment of spinal injuries and diseases. It should be
appreciated, however that the principles of the present invention
can also find application in other areas.
[0429] It is expressly understood that where the term "patient" has
been used to describe the various embodiments of the disclosure,
the term should not be construed as limiting in any way. For
instance, a patient could be either a human patient or an animal
patient, and the apparatus and methods described herein apply
equally to veterinary science as they would to surgical procedures
performed on human anatomy. The apparatus and methods described
herein therefore have application beyond surgical procedures used
by spinal surgeons, and the concepts may be applied to other types
of "patients" and procedures without departing from the spirit of
the present disclosure.
[0430] 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. In the foregoing Detailed Description for
example, various features of the disclosure are grouped together in
one or more embodiments for the purpose of streamlining the
disclosure. This method of disclosure is not to be interpreted as
reflecting an intention that the claimed disclosure requires more
features than are expressly recited in each claim. Rather, as the
following claims reflect, inventive aspects lie in less than all
features of a single foregoing disclosed embodiment. Thus, the
following claims are hereby incorporated into this Detailed
Description, with each claim standing on its own as a separate
preferred embodiment of the disclosure.
[0431] The present inventions, in various embodiments, include
components, methods, processes, systems and/or apparatuses
substantially as depicted and described herein, including various
embodiments, subcombinations, and subsets thereof. Those of skill
in the art will understand how to make and use the present
inventions after understanding the present disclosure. The present
inventions, in various embodiments, include providing devices and
processes in the absence of items not depicted and/or described
herein or in various embodiments hereof, including in the absence
of such items as may have been used in previous devices or
processes, e.g., for improving performance, achieving ease and\or
reducing cost of implementation.
[0432] Moreover, though the present disclosure has included
description of one or more embodiments and certain variations and
modifications, other variations and modifications are within the
scope of the disclosure, e.g., as may be within the skill and
knowledge of those in the art, after understanding the present
disclosure. It is intended to obtain rights which include
alternative embodiments to the extent permitted, including
alternate, interchangeable and/or equivalent structures, functions,
ranges or steps to those claimed, whether or not such alternate,
interchangeable and/or equivalent structures, functions, ranges or
steps are disclosed herein, and without intending to publicly
dedicate any patentable subject matter.
* * * * *