U.S. patent application number 17/188916 was filed with the patent office on 2021-07-22 for surgical navigation processors and systems.
This patent application is currently assigned to WENZEL SPINE, INC.. The applicant listed for this patent is WENZEL SPINE, INC.. Invention is credited to Adam DEITZ.
Application Number | 20210220057 17/188916 |
Document ID | / |
Family ID | 1000005495429 |
Filed Date | 2021-07-22 |
United States Patent
Application |
20210220057 |
Kind Code |
A1 |
DEITZ; Adam |
July 22, 2021 |
SURGICAL NAVIGATION PROCESSORS AND SYSTEMS
Abstract
Disclosed are methods and systems used with surgical navigation
systems that enable a user to generate an optimized anatomical
dataset for a spine level of interest. The systems and methods
allow users to determine a target geometry for a spinal level
targeted for spinal surgery. Additionally, the user can project
loads across the spinal orthopedic implants and determine a
projected subsidence over time.
Inventors: |
DEITZ; Adam; (Austin,
TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
WENZEL SPINE, INC. |
Austin |
TX |
US |
|
|
Assignee: |
WENZEL SPINE, INC.
Austin
TX
|
Family ID: |
1000005495429 |
Appl. No.: |
17/188916 |
Filed: |
March 1, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16562567 |
Sep 6, 2019 |
10959786 |
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17188916 |
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15169281 |
May 31, 2016 |
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16562567 |
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62268138 |
Dec 16, 2015 |
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62187930 |
Jul 2, 2015 |
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62171861 |
Jun 5, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 34/10 20160201;
A61B 2034/105 20160201; A61B 34/20 20160201; A61B 5/4566
20130101 |
International
Class: |
A61B 34/20 20060101
A61B034/20; A61B 34/10 20060101 A61B034/10; A61B 5/00 20060101
A61B005/00 |
Claims
1. A processor for use with a surgical navigation system used for
spinal surgery wherein the processor is programmed to execute:
receiving an input dataset comprising one or more medical images
containing a spinal level of interest and one or more image-derived
measurements for each medical image, wherein the one or more
image-derived measurements are selected from an alignment
measurement, a lordosis measurement, a translation measurement, an
angulation measurement, and a disc height measurement; allowing a
user to specify a data presentation by selecting one or more of the
image-derived measurements and by further selecting at least one of
a minimum value and a maximum value; identifying a specific image
view corresponding to the data presentation wherein an output of an
identification process is a reference to an image that corresponds
to the user specified data presentation; and generating comparative
data between a current status of the patient wherein the generated
comparative data uses a measurement from one or more image captured
intra-operatively via the surgical navigation system and the data
presentation.
2. The processor of claim 1, wherein the image-derived measurement
includes measurements that are derivative to the measurements
included in the input dataset.
3. The processor of claim 1, wherein the comparative data generated
includes one or more of a generated image with a template, a
generated image without a template, and a generated image compiled
from multiple imaging modalities.
4. A processor for use with a surgical navigation system used for
spinal surgery wherein the processor is programmed to execute:
receiving a pre-operative dataset and an inter-operative dataset,
wherein each of the pre-operative dataset and inter-operative
dataset comprises one or more medical images containing a spine
region of interest as well as a dataset of location values
associated with a four-point registration of each vertebral body
visible within the spine region of interest; allowing a user of the
surgical navigation system to specify an input dataset for each
vertebral body pair within the spine region of interest; and
rendering a block diagram of a spine, by using the four-point
registration dataset from the input dataset selected by the
user.
5. A machine readable medium containing instructions stored on a
non-transitory computer readable medium that, when executed by a
computing device, cause the computing device to perform a method,
the method comprising: receiving an input dataset comprising one or
more medical images containing a spinal level of interest and one
or more image-derived measurements for each medical image, wherein
the one or more image-derived measurements are selected from an
alignment measurement, a lordosis measurement, a translation
measurement, an angulation measurement, and a disc height
measurement; allowing a user to specify a data presentation by
selecting one or more of the image-derived measurements and by
further selecting at least one of a minimum value and a maximum
value; identifying a specific image view corresponding to the data
presentation wherein an output of an identification process is a
reference to an image that corresponds to the user specified data
presentation; and generating comparative data between a current
status of the patient wherein the generated comparative data uses a
measurement from one or more image captured intra-operatively via
the surgical navigation system and the data presentation.
6. The machine readable medium of claim 5, wherein the
image-derived measurement includes measurements that are derivative
to the measurements included in the input dataset.
7. The machine readable medium of claim 5, wherein the comparative
data generated includes one or more of a generated image with a
template, a generated image without a template, and a generated
image compiled from multiple imaging modalities.
8. A machine readable medium containing instructions stored on a
non-transitory computer readable medium that, when executed by a
computing device, cause the computing device to perform a method,
the method comprising: receiving a pre-operative dataset and an
inter-operative dataset, wherein each of the pre-operative dataset
and inter-operative dataset comprises one or more medical images
containing a spine region of interest as well as a dataset of
location values associated with a four-point registration of each
vertebral body visible within the spine region of interest;
allowing a user of the surgical navigation system to specify an
input dataset for each vertebral body pair within the spine region
of interest; and rendering a block diagram of a spine, by using the
four-point registration dataset from the input dataset selected by
the user.
9. A product comprising one or more tangible computer-readable
non-transitory storage media comprising computer-executable
instructions operable to, when executed by at least one processor,
enable the at least one processor to cause an experience management
system to: receive an input dataset comprising one or more medical
images containing a spinal level of interest and one or more
image-derived measurements for each medical image, wherein the one
or more image-derived measurements are selected from an alignment
measurement, a lordosis measurement, a translation measurement, an
angulation measurement, and a disc height measurement; allow a user
to specify a data presentation by selecting one or more of the
image-derived measurements and by further selecting at least one of
a minimum value and a maximum value; identify a specific image view
corresponding to the data presentation wherein an output of an
identification process is a reference to an image that corresponds
to the user specified data presentation; and generate comparative
data between a current status of the patient wherein the generated
comparative data uses a measurement from one or more image captured
intra-operatively via the surgical navigation system and the data
presentation.
10. The product of claim 9, wherein the image-derived measurement
includes measurements that are derivative to the measurements
included in the input dataset.
11. The product of claim 9, wherein the comparative data generated
includes one or more of a generated image with a template, a
generated image without a template, and a generated image compiled
from multiple imaging modalities.
Description
CROSS-REFERENCE
[0001] This application is a continuation application of U.S.
patent application Ser. No. 16/562,567 filed Sep. 6, 2019, which is
a continuation of U.S. patent application Ser. No. 15/169,281 filed
May 31, 2016, which claims the benefit of U.S. Provisional
Application No. 62/171,861, filed Jun. 5, 2015, and U.S.
Provisional Application No. 62/187,930, filed Jul. 2, 2015, and
U.S. Provisional Application No. 62/268,138 filed Dec. 16, 2015,
which applications are incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] One of the most prevalent joint problems is back pain,
particularly in the "small of the back" or lumbosacral (L4-S1)
region. In many cases, the pain severely limits a person's
functional ability and quality of life. Such pain can result from a
variety of spinal pathologies. Through disease or injury, the
vertebral bodies, intervertebral discs, laminae, spinous process,
articular processes, or facets of one or more spinal vertebrae can
become damaged, such that the vertebrae no longer articulate or
properly align with each other. This can result in an undesired
anatomy, loss of mobility, and pain or discomfort. Duke University
Medical Center researchers found that patients suffering from back
pain in the United States consume more than $90 billion annually in
health care expenses, with approximately $26 billion being directly
attributable to treatment. Additionally, there is a substantial
impact on the productivity of workers as a result of lost work
days. Similar trends have also been observed in the United Kingdom
and other countries.
[0003] As part of the diagnostic process of determining the cause
of pain coming from a joint such as the lumbar spine, health care
providers rely on an understanding of joint anatomy and mechanics
when evaluating a subject's suspected joint problem and/or
biomechanical performance issue. Currently available orthopedic
diagnostic methods are capable of detecting a limited number of
specific and treatable defects. These techniques include X-Rays,
MRI, discography, and physical exams of the patient. In addition,
spinal kinematic studies such as flexion/extension X-rays are used
to specifically detect whether or not a joint has dysfunctional
motion. These methods have become widely available and broadly
adopted into the practice of treating joint problems and addressing
joint performance issues.
[0004] What us needed are new devices and methods for determining
the target geometry for a level targeted for spinal surgery.
Additionally, devices and methods for the safe operating range of
spinal joints during surgery. Still other needs include devices and
methods for modeling and projecting various loads across spinal
orthopedic implants.
SUMMARY OF THE INVENTION
[0005] Disclosed are devices and methods for determining the target
geometry for a level targeted for spinal surgery. Additionally,
disclosed are devices and methods for the safe operating range of
spinal joints during surgery. Also included are devices and methods
for modeling and projecting various loads across spinal orthopedic
implants.
[0006] An aspect of the disclosure is directed to a machine
readable medium containing instructions stored on a non-transitory
computer readable medium that, when executed by a computing device,
cause the computing device to perform a method, the method
comprising: receiving an input dataset comprising one or more
medical images containing a spine level of interest for a patient;
and generating an optimized anatomical dataset for the spine level
of interest wherein the optimized anatomical data set comprises one
or more of a target disc height, a target anterior-posterior
offset, and a target lordosis angle, and further wherein the step
of generating an optimized anatomical dataset for the spine level
of interest comprises the steps of: identifying zero, one or more
visible spine levels in the one or more medical images to exclude
from analysis; and accessing one or more image-derived measurements
of a disc height measurement, an anterior-posterior offset
measurement, and a sagittal lordosis angle measurement for one or
more non-excluded spine levels; and applying a function to the one
or more measurements from accessing one or more image-derived
measurements to generate an optimized value for the spine level of
interest for one or more of the target disc height, the target
anterior-posterior offset, and the target lordosis angle. The
optimized anatomical data set can comprises two or more of a target
disc height, a target anterior-posterior offset, and a target
lordosis angle. Additionally, the function can receive an input and
applies one or more adjustments to correct for an assumed
post-operative subsidence of an interbody device over time. In at
least some configurations, the one or more adjustments is a disc
height adjustment, an anterior-posterior offset adjustment, and a
lordosis angle adjustment. The one or more medical images excluded
from analysis can be excluded independently for one or more of an
excluded disc height measurement, an excluded anterior-posterior
offset, and an excluded sagittal lordosis angle. The function can
also be one of an average function and a distribution function, and
further wherein an input is selected from a medical literature. A
surgical navigation system user may also specify a gross lordosis
target for an entire region of a spine and wherein the function
distributes one or more gross lordosis regional targets across a
user-specified set of levels targeted for fusion surgery.
[0007] Another aspect of the disclosure is directed to a processor
for generating estimates of a weight carried at a spine level of
interest, wherein the processor is programmed to execute: accessing
an input dataset for a patient comprising a weight of the patient,
one or more image-derived measurements of a spatial relationships
between two or more vertebral bodies visible within one or more
images; allowing a user to specify a spine level of interest; and
projecting an estimated weight carried at the spine level of
interest by: looking-up one or more values from a previously
published mass distribution function, wherein the mass distribution
function comprises a set of percentage values associated with
various bodily regions such that the sum of the set of percentage
values equals 100%; summing x from the mass distribution function
elements for all bodily regions cranial to a spinal region of
interest; calculating y from the image-derived measurements of the
spatial relationships between vertebral bodies from the input
dataset, by determining an estimated percentage of the region of
interest that is cranial to a spinal level of interest; summing x
and y; and multiplying the sum of x and y by a weight of the
patient to determine the weight carried at the spine level of
interest. Additionally, the processor is configurable to calculate
a sheer and a compressive component of the weight carried at the
spine level of interest, using the image-derived measurements of
the angulation between vertebral body endplates and a plumb line.
In at least some configurations, the input dataset contains
patient-specific data and wherein the computational routine
incorporates a lookup function that returns a mass distribution
which is a function of the patient-specific data. The
patient-specific data can be selected from, for example, age,
gender, and height. Additionally, the previously published mass
distribution function is one selected by the user from among a set
of available functions.
[0008] Still another aspect of the disclosure is directed to a
processor for use with surgical navigation systems used for spinal
surgery wherein the processor is programmed to execute: receiving
an input dataset comprising one or more medical images containing a
spine level of interest; and generating measurements of an
operating range of the spine level of interest, comprising
measurements of at least one of a minimum linear displacement
between a pair of adjacent vertebral body corner-points from the
spine level of interest and a maximum linear displacement between a
pair of adjacent vertebral body corner-points from the spine level
of interest by executing a computational process comprising:
accessing one or more medical images containing the spine level of
interest from the input dataset, and further accessing one or more
measurements from each image of at least one of the minimum linear
displacement and the maximum linear displacement; and applying at
least one of a maximum function and a minimum function to the
measurement sets to determine a maximum linear displacement value
for a pair of adjacent corner points and a minimum linear
displacement values for the pair of adjacent corner-points; and
rendering data usable by a surgical navigation system based on the
operating range measurements. The rendering of data usable by a
surgical navigation system can support a visual display of the
operating range measurements by the surgical navigation system.
Additionally, the data rendered can trigger an alert to a surgical
navigation system user when the operating range measurement for the
spine level of interest is outside of a user-determined threshold
value.
[0009] Yet another aspect of the disclosure is directed to a
processor for use with a surgical navigation system used for spinal
surgery that wherein the processor is programmed to execute:
receiving an input dataset comprising one or more medical images,
wherein each medical image includes an image of a spinal level of
interest, one or more image-derived measurements for each medical
image wherein the one or more image-derived measurements are
selected from an alignment measurement, a lordosis measurement, a
translation measurement, an angulation measurement, and a disc
height measurement; allowing a user to specify a data presentation
by selecting one or more of the image-derived measurements and by
further selecting at least one of a minimum value and a maximum
value; identifying a specific image view corresponding to the data
presentation wherein an output of an identification process is a
reference to an image that corresponds to the user specified data
presentation; and generating comparative data between a current
status of the patient wherein the generated comparative data uses a
measurement from one or more image captured intra-operatively via
the surgical navigation system and the data presentation. The
measurement of interest can include measurements that are
derivative to the input dataset. Additionally, the comparative data
generated includes one or more of a generated image with a
template, a generated image without a template, and a generated
image compiled from multiple imaging modalities.
[0010] Another aspect of the disclosure is directed to a processor
for use with a surgical navigation system used for spinal surgery
wherein the processor is programmed to execute: receiving a
pre-operative dataset and an inter-operative dataset, wherein each
of the pre-operative dataset and inter-operative dataset comprises
one or more medical images containing a spine region of interest as
well as a dataset of location values associated with a four-point
registration of each vertebral body visible within the spine region
of interest; allowing a user of the surgical navigation system to
specify an input dataset for each vertebral body pair within the
spine region of interest; and rendering a block diagram of a spine,
by using the four-point registration dataset from the input dataset
selected by the user.
[0011] An aspect of the disclosure is directed to a machine
readable medium means containing instructions stored on a
non-transitory computer readable medium means that, when executed
by a computing device means, cause the computing device means to
perform a method, the method comprising: receiving an input dataset
comprising one or more medical images containing a spine level of
interest for a patient; and generating an optimized anatomical
dataset for the spine level of interest wherein the optimized
anatomical data set comprises one or more of a target disc height,
a target anterior-posterior offset, and a target lordosis angle,
and further wherein the step of generating an optimized anatomical
dataset for the spine level of interest comprises the steps of:
identifying zero, one or more visible spine levels in the one or
more medical images to exclude from analysis; and accessing one or
more image-derived measurements of a disc height measurement, an
anterior-posterior offset measurement, and a sagittal lordosis
angle measurement for one or more non-excluded spine levels; and
applying a function to the one or more measurements from accessing
one or more image-derived measurements to generate an optimized
value for the spine level of interest for one or more of the target
disc height, the target anterior-posterior offset, and the target
lordosis angle. Additionally, the function can receive an input and
applies one or more adjustments to correct for an assumed
post-operative subsidence of an interbody device over time. In at
least some configurations, the one or more adjustments is a disc
height adjustment, an anterior-posterior offset adjustment, and a
lordosis angle adjustment. The one or more medical images excluded
from analysis can be excluded independently for one or more of an
excluded disc height measurement, an excluded anterior-posterior
offset, and an excluded sagittal lordosis angle. The function can
also be one of an average function and a distribution function, and
further wherein an input is selected from a medical literature. A
surgical navigation system user may also specify a gross lordosis
target for an entire region of a spine and wherein the function
distributes one or more gross lordosis regional targets across a
user-specified set of levels targeted for fusion surgery.
[0012] Another aspect of the disclosure is directed to a processor
means for generating estimates of a weight carried at a spine level
of interest, wherein the processor means is programmed to execute:
accessing an input dataset for a patient comprising a weight of the
patient, one or more image-derived measurements of a spatial
relationships between two or more vertebral bodies visible within
one or more images; allowing a user to specify a spine level of
interest; and projecting an estimated weight carried at the spine
level of interest by: looking-up one or more values from a
previously published mass distribution function, wherein the mass
distribution function comprises a set of percentage values
associated with various bodily regions such that the sum of the set
of percentage values equals 100%; summing x from the mass
distribution function elements for all bodily regions cranial to a
spinal region of interest; calculating y from the image-derived
measurements of the spatial relationships between vertebral bodies
from the input dataset, by determining an estimated percentage of
the region of interest that is cranial to a spinal level of
interest; summing x and y; and multiplying the sum of x and y by a
weight of the patient to determine the weight carried at the spine
level of interest. Additionally, the processor is configurable to
calculate a sheer and a compressive component of the weight carried
at the spine level of interest, using the image-derived
measurements of the angulation between vertebral body endplates and
a plumb line. In at least some configurations, the input dataset
contains patient-specific data and wherein the computational
routine incorporates a lookup function that returns a mass
distribution which is a function of the patient-specific data. The
patient-specific data can be selected from, for example, age,
gender, and height. Additionally, the previously published mass
distribution function is one selected by the user from among a set
of available functions.
[0013] Still another aspect of the disclosure is directed to a
processor means for use with surgical navigation system means used
for spinal surgery wherein the processor means is programmed to
execute: receiving an input dataset comprising one or more medical
images containing a spine level of interest; and generating
measurements of an operating range of the spine level of interest,
comprising measurements of at least one of a minimum linear
displacement between a pair of adjacent vertebral body
corner-points from the spine level of interest and a maximum linear
displacement between a pair of adjacent vertebral body
corner-points from the spine level of interest by executing a
computational process comprising: accessing one or more medical
images containing the spine level of interest from the input
dataset, and further accessing one or more measurements from each
image of at least one of the minimum linear displacement and the
maximum linear displacement; and applying at least one of a maximum
function and a minimum function to the measurement sets to
determine a maximum linear displacement value for a pair of
adjacent corner points and a minimum linear displacement values for
the pair of adjacent corner-points; and rendering data usable by a
surgical navigation system based on the operating range
measurements. The rendering of data usable by a surgical navigation
system means can support a visual display means of the operating
range measurements by the surgical navigation system means.
Additionally, the data rendered can trigger an alert to a surgical
navigation system user when the operating range measurement for the
spine level of interest is outside of a user-determined threshold
value.
[0014] Yet another aspect of the disclosure is directed to a
processor means for use with a surgical navigation system means
used for spinal surgery that wherein the processor means is
programmed to execute: receiving an input dataset comprising one or
more medical images, wherein each medical image includes an image
of a spinal level of interest, one or more image-derived
measurements for each medical image wherein the one or more
image-derived measurements are selected from an alignment
measurement, a lordosis measurement, a translation measurement, an
angulation measurement, and a disc height measurement; allowing a
user to specify a data presentation by selecting one or more of the
image-derived measurements and by further selecting at least one of
a minimum value and a maximum value; identifying a specific image
view corresponding to the data presentation wherein an output of an
identification process is a reference to an image that corresponds
to the user specified data presentation; and generating comparative
data between a current status of the patient wherein the generated
comparative data uses a measurement from one or more image captured
intra-operatively via the surgical navigation system and the data
presentation. The measurement of interest can include measurements
that are derivative to the input dataset. Additionally, the
comparative data generated includes one or more of a generated
image with a template, a generated image without a template, and a
generated image compiled from multiple imaging modalities.
[0015] Another aspect of the disclosure is directed to a processor
means for use with a surgical navigation system means used for
spinal surgery wherein the processor means is programmed to
execute: receiving a pre-operative dataset and an inter-operative
dataset, wherein each of the pre-operative dataset and
inter-operative dataset comprises one or more medical images
containing a spine region of interest as well as a dataset of
location values associated with a four-point registration of each
vertebral body visible within the spine region of interest;
allowing a user of the surgical navigation system to specify an
input dataset for each vertebral body pair within the spine region
of interest; and rendering a block diagram of a spine, by using the
four-point registration dataset from the input dataset selected by
the user.
INCORPORATION BY REFERENCE
[0016] All publications, patents, and patent applications mentioned
in this specification are herein incorporated by reference to the
same extent as if each individual publication, patent, or patent
application was specifically and individually indicated to be
incorporated by reference. See, for example, U.S. Pat. No.
8,676,293 issued Mar. 18, 2014 to Breen for Devices, systems and
methods for measuring and evaluating the motion and function of
joint structures and associated muscles, determining suitability
for orthopedic intervention, and evaluating efficacy of orthopedic
intervention; U.S. Pat. No. 8,777,878 issued Jul. 15, 2014, to
Deitz for Devices, systems, and methods for measuring and
evaluating the motion and function of joints and associated muscles
and U.S. Pat. No. 7,502,641 issued Mar. 10, 2009, to Breen for
Method for imaging the relative motion of skeletal segments
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The novel features of the invention are set forth with
particularity in the appended claims. A better understanding of the
features and advantages of the present invention will be obtained
by reference to the following detailed description that sets forth
illustrative embodiments, in which the principles of the invention
are utilized, and the accompanying drawings of which:
[0018] FIG. 1 illustrates two pairs of vertebral bodies which
illustrates a normal pair and an offset pair;
[0019] FIGS. 2A-D illustrates a method for determining a target
geometry for a spine surgery which allows a user to select a
construct and provide for any exclusions (FIG. 2A), the vertebral
bodies represented as rectangles illustrating PDH, ADH and offset
(FIG. 2B), an image legend of maximum, current values, and minimum
(FIG. 2C), and an application of the image legend to an exemplar
pair of vertebral bodies represented by rectangles (FIG. 2D);
[0020] FIG. 3A illustrates a hardware diagram having a computer in
communication with an analog video port and a surgical C arm, FIG.
3B illustrates a home screen for software;
[0021] FIG. 4 illustrates the Capture Image functionality (a first
function of the system);
[0022] FIGS. 5A-C illustrate the Confirm Position functionality (a
second function of the system);
[0023] FIGS. 6A-B illustrate the Navigate functionality (a third
function of the system);
[0024] FIG. 7 illustrates an exemplar screen for a Rothenfluh
configuration;
[0025] FIG. 8 illustrates an exemplar screen for a Roussouly
configuration;
[0026] FIGS. 9A-B illustrates sagittal alignment maps for
Rothenfluh configuration and Roussouly configuration;
[0027] FIG. 10 illustrates an exemplar mark-up diagram;
[0028] FIG. 11 illustrates exemplar data for lordosis at a
plurality of spinal levels;
[0029] FIG. 12 illustrates an exemplar geometric transformation
calculation; and
[0030] FIG. 13A-C illustrate methods for projecting loads.
DETAILED DESCRIPTION
[0031] One aspect of the present disclosure relates to a method for
determining the target geometry of a spinal fusion surgical
construct. Radiographic images of a patient's spine are acquired
via any radiographic imaging method. From these images, specific
measurements can be collected at levels not targeted for surgery
from images collected while a patient is standing in a neutral
position, including: anterior disc height, posterior disc height,
offset (i.e. intervertebral translation), and/or angulation. These
measurements are then used to generate a patient-specific average
from the levels imaged but not targeted for surgery. These averages
are then used to determine a set of target parameters for a
surgical construct. These target parameters may then be used as the
input to a surgical navigation system or may be used by the surgeon
during surgery for device selection or to assist with the surgery.
FIG. 1 illustrates two vertebral bodies in a current orientation
and a target orientation with anterior disc height (ADH), posterior
disc height (PDH) and offset.
[0032] As shown in FIGS. 2A-D a system user can select or exclude
constructs for a plurality of vertebral pairs. For example, a
patient targeted for surgery at L4/L5 may have lumbar spine
radiographic images. Measurements of ADH, PDH, and Intervertebral
translation (WT) are then collected at Levels L1/L2, L2/L3, L3/L4,
and potentially L5/S1, and averaged across these levels. These
average parameters are the output of this method. The user may opt
to delete specific levels from this average calculation, as shown
in FIG. 2A.
[0033] Once these averages have been tabulated by the system, the
user can view the resulting construct. The construct is as a series
of points on a lateral and/or anterior-posterior projection of the
anatomy. As will be appreciated the construct could also be a
series of points on a 3D modality such as magnetic resonance
imaging (MRI) or computed tomography (CT). These construct points
may be manipulated by the user as shown in FIGS. 2B-D.
[0034] The data describing the target construct is created in a way
that it is available for use by the surgical navigation system,
having incorporated physician-specific assumptions as well as
patient-specific data from prior diagnostic studies, such that it
is unnecessary for any specific pre-surgical planning work step on
the part of the surgeon. This workflow may incorporate image
processing services that do processing of images and external
reviews by radiologists. This workflow may also incorporate
pre-rendered paper or pdf reports that allow target constructs
parameters to be accessed by a user.
[0035] The system reduces workflow by enabling a user to determine
whether a patient moves under a gravitational load of about 20%.
Thus, when positioning a patient, the user can quickly determine
whether it would be effective to attempt to get the level to open
or reduce (i.e., is the level at its maximum mobility).
Quantitative feedback provides assurance to the surgeons which
results in increased definitive decision making in the operating
room. Additionally, the systems is configurable to provide
actionable new data. For example, the system can alert a user or
surgeon when a "pharmaceutical reduction" is occurring. Information
about, for example, a pharmaceutical reduction, can change a
surgical decision from decompression to fusion. Additionally, the
system is configurable with no touch constructs. Thus a surgeon can
analyze the projected impact of different surgical constructions
which takes into consideration, for example, implant size,
anticipated subsidence, sheer and compressive loads, and PI-LL. The
system also allows for confirmation of implant placement.
[0036] Once target construct has been determined, then
intra-operative feedback systems can be used during surgery to
assess current status of the geometry of a patient's spine surgery
construct at a level or levels relative to the target construct's
parameters as described above. This could be accomplished by having
a fluoroscopic imaging device connected to a computer-mounted piece
of frame-grabbing hardware configurable to digitize an image which
could then undergo registration of the disc space on the image by a
user (i.e., the space between two vertebral bodies in the spine).
Once registered, this system would compare the registered image
against the target and provide feedback to a surgeon user as to how
much more a construct's geometry needs to be changed to achieve the
target geometry. See FIGS. 3A-B, 4, and 6A-B.
[0037] This system is configurable to allow the user to incorporate
various assumptions about levels of subsidence of device implants.
This could mean that a target construct is sized to be larger than
what is desired to be achieved post-operatively after patient
recovery, so that after subsidence occurs the construct achieves
the target construct geometry. This system is also configurable to
allow the user to see the effects of the target construct on
pre-operative parameters such as (Pelvic incidence minus lumbar
lordosis) as well as the type of implant device dimensions that
would be required to achieve the surgical construct. These
parameters (target construct geometry, implant dimensions,
projected forces, pelvic incidence minus lumbar lordosis, etc.) can
all be changed dynamically, and when one parameter is changed the
effect of the change is displayed for all other parameters. In
addition the system can allow the user to configure a user-defined
set of assumptions about the magnitude and distribution of
projected subsidence. These assumptions could additionally be
affected by surgeon input, such as the surgeon inputting data that
the patient has osteoporosis or otherwise has bad bone quality, is
obese, elderly, scoliotic, or other factors that could affect
subsidence. Subsidence assumptions could be further personalized to
a specific patient based on projected compressive gravitational
loads across an implant. See FIG. 6A.
[0038] A second aspect of the disclosure is a method for
determining the safe operating range of spinal joints during
surgery. This method involves the use of a system that can assess
the operating range of spinal levels (in terms of intervertebral
rotation/angulation and translation) as an input device. Data for
each level of the spine that has been measured is provided
regarding the maximum and minimum observed rotation, translation,
anterior disc height, and posterior disc height, as measured from a
range of bending and load conditions. These ranges therefore
represent the ranges to which spinal levels will go under voluntary
movement conditions, which represents the sub-acute range with
respect to potential ligamentous injury that could occur during
spinal surgery due to external compressive or distractive forces
applied by the surgeon during surgery. Such compressive and
distractive forces are often applied during spinal surgery, during
patient positioning when surgeons often attempt to induce maximum
lordosis at a level, when determining the size and
geometric/spatial configuration of the implant relative to the disc
space, and when assessing of implanted hardware has been properly
placed and configured. Image data from a previous diagnostic study
could be available and accessible intraoperatively so a surgeon
could selectively view the anatomy in specific positions, such as
most lordotic, most kyphotic, most reduced, greatest anterior disc
height, least anterior disc height, greatest posterior disc height,
least posterior disc height, greatest opening to patient left,
least opening to patient left, greatest opening to patient right,
or least opening to patient right. See FIG. 6B.
[0039] This data about the minimum and maximum observed range of
motion is then used with an intra-operative feedback systems to
assess current status of the geometry of a patient's spine surgery
construct at a level or levels relative to the minimum and maximum
operating range of that joint (as described directly above). This
could be accomplished by having a fluoroscopic imaging device
connected to a computer-mounted piece of frame-grabbing hardware
that could digitize an image which could then undergo registration
of the disc space on the image by a user. Once registered, this
system would compare the registered image against the minimum and
maximum data and provide feedback to a surgeon user as to where the
current anatomy is relative to its maximum and minimum demonstrated
operating range. See FIG. 6A.
[0040] A third aspect of the disclosure includes a system for
assisting with the positioning of a patient on an operating table
prior to a surgery. Data from previous diagnostic studies of
intervertebral motion would be available for comparison to a
current position as captured using the frame grabber and
fluoroscopic imaging device (as previously described). During
patient positioning prior to surgery, the surgeon is often trying
to achieve a specific position for a level targeted for spine
surgery, such as maximum lordosis or most reduced. Using data from
prior imaging studies along with a registered image taken during
the patient positioning routine that occurs prior to surgery, the
surgeon could compare a current position to the level's known range
of operation to determine how much more positioning, if any, is
required to achieve the target position for surgery. In the case
that a patient that is anesthetized reduces more than has been
observed on prior imaging studies, an alert could be triggered. See
FIGS. 5A-C.
[0041] According to an embodiment of the disclosure, there is a
lengthy requirements specification for a product that is capable of
achieving the objects of the first through third aspects above, as
well as other objectives. This requirements specification is
provided in its entirety below, after which a fourth aspect of the
disclosure is provided.
[0042] The systems can be summarized as having exemplar hardware
features, and exemplar functional features.
[0043] Hardware Features: [0044] The system can be
IEC60601-compliant [0045] The system can be a console mounted
computer. [0046] The system can have encrypted fixed media. [0047]
The system can allow for frame capture of an analog input from a
surgical C-arm [0048] The system can have the following hardware
user interfaces: Mouse; Keyboard; USB Media port; Main monitor;
Slave monitor. [0049] The system typically does not include:
External/network connectivity; or Touchscreen Input
Capabilities
[0050] Functional Features: Overall Application: [0051] The system
can consist of an application that loads upon boot-up. [0052] The
system can be locked down, so that users can only access the system
software application, and none of the resident functions within
windows, unless a user presses a keystroke that will be known only
to technicians. [0053] The system can require a user to login using
a username and password or a username and by answering security
questions [0054] The system can be shut down via user controls
within the system Software. [0055] Every screen of the software can
feature a company or product logo, the system software version
number, and the current date/time [0056] There can be 3 major
screens: Splash/Login Screen; Main Screen; Capture Screen [0057]
There can be one or more of the following modal windows: Load New
Patient; Load Previous Session; Edit disc height (A1); Edit offset
(A2); Edit Lordosis (A3); Lordosis Distribution Calculations,
Rothenfluh (B1); Lordosis Distribution Calculations, Roussouly
(B1); Edit Correction for Anticipated Subsidence (C1); and
Calibrate (D) [0058] Typically, there are be three main user types
for the system: [0059] Surgeon: A surgeon can access any and all
functionality of the system. The surgeon can access all previous
patients saved to this system, and optionally (a site-level
parameter) can open patients from any other surgeon who has saved
cases to the system. [0060] OR Admin: The OR Administrator is an
operating room administrator who can access any patient saved to
the system and all functionality except making edits on the
configuration screen (they can view, but not change the data).
[0061] System Administrator: The System Administrator can change
site level parameters and reset passwords for OR Admin and Surgeon
users. [0062] The input data for the system software is typically
provided as an encrypted file to protect patient privacy that is
accessed via USB media, and that was created by an online system as
a rendered patient data package. See the "Input File Features"
section for more details about this input file.
[0063] Functional Features: Data Saying and Storage [0064] For each
use session, the system can store one or more of at least: [0065]
all actions taken by all users during all use sessions, excluding
simple navigation. The actions that can be stored are defined as
those that can affect any data structure within the system software
system. [0066] a log a time/date/user stamp along with the action
being taken. [0067] the default configuration values associated
with a surgeon user at the initialization of a use session, and
changes to these configuration values made during the session.
[0068] the input data file. [0069] The system can be configurable
to recall any instance of a user session. This may be done by
saving each instance before it is changed, or by storing sufficient
data during each user session such that any instance of a user
session can be reconstructed. [0070] The system is also
configurable to store each testing event in a first in, first out
(FIFO) queue [0071] The queue system can use all allotted hard disc
space, deleting older testing events first as more hard drive space
is needed. [0072] If and when the system is deleting older testing
events, the system can present a message to the user prior to the
deletion and allow the user to cancel the delete action. [0073] The
system is configurable to store the following information for each
user: [0074] Data associated with each ADMIN user including,
Username, password, and password help questions. [0075] Data
associated with each SURGEON user including, User config variables,
and acceptance status of the click through agreement, plus
date/time of acceptance; and Username, password, and password help
questions. [0076] Site level parameters and data that gest stored:
[0077] The system is configurable to log all successful and
unsuccessful login attempts. [0078] Site configuration variable:
Can Surgeons access patients created by other Surgeons? [0079] To
retrieve data from the system, the system is configurable to store
data in such a way that it is accessible to a system trained
technician by executing the technician Keystroke, then doing a
manual copy of files from the system to removable media. This
storage process can be fulfilled once a file structure exists that
is accessible via the WINDOWS file explorer (or equivalent
function) for copying to external media.
[0080] Functional Features: Video Frame Capture [0081] The system
is configurable to connect to an output port on a C-arm of the type
DVI (capable of supporting both analog and digital signals). See.
FIG. 3A. [0082] Adapters can be used as needed or desired, to
convert between DVI and other ports such as BNC, VGA, and others.
[0083] The system is configurable to: [0084] Receiving a live video
stream from the C-arm, for display by the software [0085] Upon
command, digitizing a current frame of the live video stream, and
saving that image as a file that is usable by the software.
[0086] Splash/Login Screen: [0087] Users can enter usernames,
either by free text edit or by accessing a drop down list of
existing user accounts that have been created on the system. [0088]
Users can enter a password or provide answers to security
questions, in order to log into the system. Alternative means of
authentication can be used without departing from the scope of the
disclosure including RFID control, biometric data, and the like.
Upon login: [0089] If the user is a Surgeon type: check to see if:
(1) the user typically has not been through the click throughs in
the User Configuration pages, or (2) the user configuration pages
have changed. If so, the user gets put into the configuration pages
and can't progress to the Main Screen until the click through
agreement has been agreed to. [0090] The system can be capable of
popping up the instructions for use (IFU) with click-through
acknowledgement for the user's first login, and each time the IFU
is updated. [0091] The system is configurable to provide pop-up
custom messages with a click-through acknowledgment, for assuring
that all users are informed of updates such as release notes when
software is updated and other messages. [0092] Users can be able to
create new user accounts. [0093] Users can provide security
questions and answers in the case that passwords cannot be
remembered by the user. [0094] Passwords can be resettable by
system administrator users. [0095] Users can be able to select
"remember me", which will pull up the prior username upon
initialization of the Splash/Login Screen [0096] Users may also
initiate a shutdown
[0097] Main Screen [0098] The Main Screen can be comprised of the
following elements: [0099] A first row of buttons (with User
Manual, Load Patient, and Exit buttons) [0100] A second row of
buttons (with the Report, Capture, Calibrate, and Configure. In at
least some configurations, the Report and Capture buttons can only
appear after a patient has been loaded). [0101] A left pane, which
can assume three states [0102] Sagittal Alignment Diagram [0103]
Lumbar View [0104] Disc Space View [0105] A right pane, which can
assume two states: [0106] Surgery Summary [0107] Level Summary
[0108] With respect to how the left and right panes are displayed:
[0109] The initial default view (upon first coming to the Main
Page) can be the Sagittal Alignment Diagram (left pane) and Surgery
Summary (right pane). [0110] The left and right pane can be
independently changed by clicking a tab contained in a row of tabs
at the top of each of the left and right panes. [0111] The
following can be visible and active to all users under all user
scenarios: [0112] On the first row of buttons: [0113] Users can
access an "Exit" button. Upon clicking the Exit button, users may
be presented with the option to "Exit patient" (which puts user
back on the surgery summary screen in its state when no patient has
been loaded), "Logoff [USER]" (which puts the user back on the
splash/login screen), and "Shutdown" (which initiates a shutdown
sequences [0114] Users can also access a "Load Patient" button,
which pops up the "Load New Patient" Modal Window. [0115] Prior to
popping up the "Load New Patient" modal window, if an existing
patient is loaded, user is warned that loading a new patient will
close the current patient. [0116] Users can be able to access a
"User Manual" button, which pops up the current version of the user
manual in a pdf viewer window. [0117] On the second row of buttons:
[0118] Users can be able to access a "Calibrate" modal window by
pressing a button [0119] Prior to calibration there can be a
ghosted, mismatched crosshair icon presented on the button. [0120]
After calibration there can be one sharp crosshair, and the label
changes to "RECALIBRATE". [0121] Users can be able to access a
"Configure" button, that navigates the patient to the CONFIGURATION
screen [0122] The following can be visible and active to all users
once a patient has been loaded: [0123] On the left pane of the
window, there can be: [0124] A series of tabs across the top
section of the left pane. There can be seven tabs: "L1/L2",
"L2/L3", "L3/L4", "L4/L5", "L5/S1", "Sagittal Alignment Diagram",
"View Lumbar Images" [0125] On each of the five tabs associated
with the five lumbar levels, there can also be a check box and a
label saying "Fusion?" [0126] In the case that user config
specifies the Roussouly method, then when the status variable
[ADDITIONAL LORDOSIS FOR SA CORRECTION STATUS]="Not Confirmed" AND
on the Surgery Summary object, the value in the "Additional
Lordosis for Sagittal Alignment Corrections" edit box is not-zero,
then: [0127] the tab for each level ("L1/L2", "L2/L3", "L3/L4",
"L4/L5", "L5/S1") can be inactive/ghosted, although the user can
still be able to select a level for fusion for one of the levels
(via the checkbox included in the tab). [0128] There can be a
prominent message to the user, with graphic objects such as arrows,
that show that the user can either edit the value or press the OK
button (these appear in the Surgery Summary in the middle section)
to proceed to the Disc Space View. Without such messaging, the user
may not have the knowledge as to why the tabs are ghosted and how
to get to Disc Space View. [0129] A main section of the left pane,
which can be configured to contain one of three objects: Sagittal
Alignment Diagram, Disc Space View, and View Lumbar Images. The
user navigates to the three objects by selecting the appropriate
tab (the tabs with the "L1/L2" "L5/S1" labels take the user to Disc
Space View). Each of these three objects is described in a
subsequent dedicated section of this document. [0130] On the right
pane of the window, there can be: [0131] A series of tabs across
the top section of the right pane. There can be three tabs:
"Surgery Summary", "Level Summary", or "Capture". [0132] A main
section of the right pane, which can contain one of two objects:
Surgery Summary Object or the Level Summary Object. The pane is
selectable by the user by clicking one of the tabs. [0133] If the
user selects "Capture", then the "Capture" Screen can appear, which
comprises a specific design for the left and right panes of the
screen and is described in Detail in the "Capture" Section of this
document. [0134] If [ACTIVE LEVEL] is null, then the "Level
Summary" tab can be inactive/ghosted. (see the Status Variable
section of this document for more information about the [ACTIVE
LEVEL] variable). [0135] On the second row of buttons: [0136] A
"Report" button can be visible, which can pull up the report as a
pdf document within a pdf viewer. The pdf viewer can occupy the
entire window, and the only navigation available to the user at
that point is "Done" and "Exit". [0137] Once a user exits, if they
re-open the viewer, it can automatically resume at the last page
the user was looking at. [0138] A "Capture" button can be visible,
which can pull up the "Capture" Screen, which comprises a specific
design for the left and right panes of the screen and is described
in Detail in the "Capture" Section of this document.
[0139] Main Screen, Right Pane: Surgery Summary [0140] There can be
a matrix of objects, arranged as a table, which can include: [0141]
Row Labels for each level "L1/L2" "L5/S1" [0142] A column of
Checkboxes to specify a level for fusion [0143] Specifying a level
can check all three of the "exclude" boxes (from disc height,
offset such that the two vertebra are not perfectly aligned, and
lordosis calculations) associated with that level. [0144] These
check boxes can be synchronized with the fusion checkboxes on the
tabs at the top of the left pane. [0145] A column space direction
to the right of the column of checkboxes that may display alert
icons whenever alerts are activated for a given patient use session
and for a specific level that has been selected for fusion surgery.
The user can move the mouse over the icon mouse to present text
appropriate with each activated alert. For more detailed features
about the behavior of these alerts, see the "Alerts Features"
section of this document. [0146] A set of three columns of
checkboxes labeled "Model Exclusions" [0147] Deselecting the check
box has no effect of the status of the checkboxes that indicate
which levels are selected for fusion. [0148] Each of the second and
the third columns (Disc Height and Offset) can independently be
either active or ghosted/inactive based on whether the value for
the Disc Height and/or Offset status variable [CHECKBOX COLUMNS
ACTIVE] is TRUE or FALSE (respectively). [0149] For each row of
checkboxes, selecting that row to receive fusion system can
automatically select the three checkboxes. Deselecting the check
box has no effect on the select/deselect status of the checkboxes
that indicate a level is selected to receive fusion. [0150] The
three columns system can contain: [0151] A column of Checkboxes to
exclude a level from Lordosis calculations with the column header
label "Lordosis" [0152] A column of Checkboxes to exclude a level
from disc height average calculations with the column header label
"Disc Height" [0153] A column of Checkboxes to exclude a level from
offset average calculations with the column header label "Offset"
[0154] Edit button to edit Lordosis, that takes you to the "Edit
Lordosis" (Modal window) [0155] Edit button to edit disc height,
that takes you to the "Edit Disc Height" (Modal window) [0156] Edit
button to edit offset, that takes you to the "Edit Offset" (Modal
window) [0157] A column of labels/dropdown labeled "Lordosis Data
Source" [0158] For levels that have not been selected for fusion,
this can be a static label that can be visible for all levels
[0159] For level that are selected for surgery, there system can a
drop-down instead of just a label: [0160] If there has not been a
capture, then this is defaulted to "Target" and the values in the
drop down are, for example, "Target", and other labels [0161] If
they have undergone a capture, this is defaulted to capture and the
values in the drop down can be "Capture", "Target", and other
labels. [0162] There can be a middle section, which system can
assume one of two configurations, based on the user configuration
selection of either the "Rothenfluh" or the "Roussouly" method for
determining Sagittal Alignment corrections. [0163] For users
configured to the "Rothenfluh" selection, there can be: [0164] A
title label: "Edit/Confirm Additional Lordosis to Correct Sagittal
Alignment" [0165] A matrix of information: [0166] A row of five
labels: "Pre-Op", "Change vs Pre-Op: Segmental Lordosis (summed
across all fusion levels)", "L1-S1 Sagittal Alignment Correction",
"Correction for Anticipated Subsidence (summed across all fusion
levels)", and "Post-Op" [0167] Next to the "Change vs Pre-Op:
Segmental Lordosis (summed across all fusion levels)" label, there
can be an edit button that pops up the Edit Lordosis modal window.
[0168] Next to the "L1-S1 Sagittal Alignment Correction" label,
there can be an edit button that pops up the appropriate modal
window from the set (Lordosis Distribution Calculations, Rothenfluh
B1; and Lordosis Distribution Calculations, Roussouly B2) based on
the value in User Config. [0169] Next to the "Correction for
Anticipated Subsidence (summed across all fusion levels)" label,
there can be an edit button that pops up the Edit Correction for
Anticipated Subsidence modal window. [0170] Underneath each label,
there can be a value in degrees (rounded to the nearest whole
number). [0171] On the leftmost and rightmost of these values:
there can be a label "PI-LL=" to the left of the displayed values.
there can be space to display a single alert icon (either yellow or
red) plus the short text "SA". For more detailed features about the
behavior of these alerts, see the "Alerts Features" section of this
document. [0172] On the middle three of these values, the value is
given as "+" or "-" a number to the left of the value. [0173] On
the value under the label "L1-S1 Sagittal Alignment Correction",
there can be: a single edit box with up/down increment buttons,
which becomes active and non-null whenever at least one level is
selected for fusion. See the "Calculations Features" section for
the behavior of the variable in the edit box There can be an "OK"
Button that is active whenever the edit box value is non-zero AND
the status variable [ADDITIONAL LORDOSIS FOR SA CORRECTION STATUS]
is set to "Not Confirmed" (See the Status Variable Features section
of the document). Once either of these two actions is done, the OK
button is invisible. A label "Computed value based on default
settings", along with the value in degree units rounded to the
nearest whole number with either a "+" or "-" next to the number as
appropriate. [0174] FIG. 7 is a graphical representation of the
features for the middle section for the "Rothenfluh" configuration:
[0175] For users configured to the "Roussouly" selection, there can
be: [0176] A title label: "Enter Any Desired Corrections to
Upper/Lower Lumbar Arcs" [0177] A simple diagram on the left side
of the middle section: [0178] A line angled to the angle of the
superior edge of L1 in standing uncontrolled neutral, next to the
label "L1" [0179] A line with a label "Apex of lumbar curve"
pointing to another label "LX" where "LX" is a variable set to the
value of the apex of the lumbar curve (See the Calculations
Features section for more information about the lumbar apex
calculation). [0180] A line angled to the angle of the superior
edge of S1 in standing uncontrolled neutral, next to the label
"S1". [0181] A matrix of information, including: [0182] A row of
five column header labels: "Pre-Op", "Change vs Pre-Op: Segmental
Lordosis (summed across all fusion levels)", "L1-S1 Sagittal
Alignment Correction", "Correction for Anticipated Subsidence
(summed across all fusion levels)", and "Post-Op" [0183] Next to
the "Change vs Pre-Op: Segmental Lordosis (summed across all fusion
levels)" label, there can be an edit button that pops up the Edit
Lordosis modal window. [0184] Next to the "L1-S1 Sagittal Alignment
Correction" label, there can be an edit button that pops up the
appropriate modal window from the set (Lordosis Distribution
Calculations, Rothenfluh B1; and Lordosis Distribution
Calculations, Roussouly B2) based on the value in User Config.
[0185] Next to the "Correction for Anticipated Subsidence (summed
across all fusion levels)" label, there can be an edit button that
pops up the Edit Correction for Anticipated Subsidence modal
window. [0186] Two row header labels: "Upper Arc" and "Lower Arc".
[0187] A 5.times.2 array of data, showing values in degree units,
rounded to the nearest whole number/ [0188] On the middle three of
these values, the value is given as "+" or "-" a number to the left
of the value. [0189] For the two values in the column labeled
"L1-S1 Sagittal Alignment Correction", these can be edit boxes with
up/down increment buttons. The defaulted value can be zero If no
levels are selected for surgery in the upper arc, then the upper
arc edit box can be ghosted and not editable. The same system can
apply to the lower arc edit box. [0190] A row of information, with
the label "Lordosis Type", with the lordosis type underneath both
the "PRE-OP" and "POST-OP" columns, and being able to assume the
values 1, 2, 3, or 4. [0191] A row of information, with the label
"Pelvic Tilt", with the Pelvic Tilt value underneath both the
"PRE-OP" and "POST-OP" columns, and being a value in degree units
that is rounded to the nearest whole number. [0192] There can be
two spaces, each one able to show a triangle icon, either yellow or
red, plus the short text "SA". Each alert icon/short text is
horizontally spaced next to the each of the two columns of data
associated with "Lordosis Type" and "Pelvic Tilt" (as described
directly above), and vertically spaced between those two rows. See
the "Alerts Features" Section for more specification about the
conditions that various alerts become active. [0193] FIG. 8 is a
graphical representation of the features for the middle section for
the "Roussouly" configuration:
[0194] Main Screen, Right Pane: Level Summary [0195] In the case
that the [ACTIVE LEVEL] is not selected for fusion, there can be no
visible objects in this panel. (note: See the section Main Screen
for more info about the [ACTIVE LEVEL] variable). [0196] In the
case that the [ACTIVE LEVEL] is selected for fusion, there can be
two sub-panels: An upper sub-panel for Surgical Considerations and
lower one for Lordosis Analysis: [0197] The upper sub-panel for
Surgical Considerations system can: [0198] Have a label which says
"[ACTIVE LEVEL] Surgical Considerations" [0199] up to three alerts,
each one comprising an icon and alert text. See the Alerts Features
section of the features document for more details about features
for these alerts. [0200] The lower sub-panel for Lordosis Analysis
system can: [0201] Have a label which says "[ACTIVE LEVEL] Lordosis
Analysis" [0202] There can be a matrix of values, comprising:
[0203] A row of four column heading labels: "Expected Lordosis @
[ACTIVE LEVEL]", "Sagittal Alignment Correction", "Correction for
Anticipated Subsidence*", and "Segmental Lordosis Target". Next to
the "Expected Lordosis @ [ACTIVE LEVEL]" label, there can be an
edit button that pops up the Edit Lordosis modal window. Next to
the "Sagittal Alignment Correction" label, there can be an edit
button that pops up the appropriate modal window from the set
(Lordosis Distribution Calculations, Rothenfluh B1; and Lordosis
Distribution Calculations, Roussouly B2) based on the value in User
Config. Next to the "Correction for Anticipated Subsidence*" label,
there can be an edit button that pops up the Edit Correction for
Anticipated Subsidence modal window. [0204] Underneath the column
headers, in the second through the fourth column can be an editable
text box, arranged in a row beneath the row of column headings,
with up/down increment buttons, and defaulted to the computed
value. This row can have the row heading of "Target Construct"
[0205] In that same row, underneath the column header in the first
column, there can be a value for expected Lordosis at [ACTIVE
LEVEL]. [0206] Underneath the "Target Construct" row described
above, there is another row of degree values (#.degree., one for
each column, with the row heading of "Computed Values based on
default settings." [0207] See "Calculation Features" section for
more details about the values that are displayed in these boxes.
[0208] Underneath the "Computed Values" row, aligned with the
"Correction for Anticipated Subsidence" column, there can be a
label for "Maximum Anticipated Anterior Subsidence*", and
underneath that there can be an editable text box with up/down
increment buttons and containing a value in millimeter units (#0.4
mm). [0209] There can be a label in red next to the editable text
box "Maximum Anticipated Anterior Subsidence" that says "Default
value was adjusted down because gravity is acting nearly parallel
to the level". This label only appears if there has been an
automatic reduction to the default MAAS value (see the Calculation
Features section for more details about the conditions when this
can occur). [0210] There can be a label at the very bottom of the
panel that displays a note explaining what is meant by the asterisk
next to the labels "Correction for Anticipated Subsidence*" and
"Maximum Anticipated Anterior Subsidence*". That label system can
say "* This estimate of potential lordosis loss due to subsidence
is a geometric calculation based on the individual vertebral body
dimensions of each patient. This calculation uses an assumed
"Maximum Anticipated Anterior Subsidence" which represents the
upper end of expected subsidence. Consider adjusting upward from
the default value when patient has poor bone quality or when
interbody device placement is posterior. Consider adjusting
downward from the default if the level receives anterior fixation
or when interbody device placement is anterior." [0211] See
"Calculation Features" section for more details about the values
that are displayed in these boxes, including the default values and
how these values change.
[0212] Main Screen, Left Pane: Sagittal Alignment Diagram [0213]
There can be block diagrams of the anterior column of the spine,
based on the coordinates of each vertebral body from the standing
uncontrolled neutral view. [0214] The diagram can be updated with
any change to: [0215] The set of levels selected for fusion. [0216]
The lordosis data source specified at a level [0217] The target
construct geometry, for levels specified to draw lordosis data from
the target construct. Target construct geometry can be changed by a
number of user actions. Any of the items that can change the target
construct can also therefore trigger an update to the Sagittal
Alignment diagram. [0218] A capture, for levels specified to draw
lordosis data from a capture [0219] Each vertebral body can be
labeled [0220] The femoral head can be represented by two circles.
[0221] There can be the following lines overlaid: [0222] A. A line
along the top of L1 [0223] B. Two diagonal lines overlaid on L1,
connecting opposing corners [0224] C. A line perpendicular to A
that intersects with the intersection of the diagonal lines in B,
and extends to the intersection of E [0225] D. A line along the top
of S1 [0226] E. A line perpendicular to D that intersects D at the
midpoint of the upper edge of S1. [0227] F. A line connecting the
center points of the femoral head circles. [0228] G. A line
originating at the midpoint of F and extending to the intersection
of D and E. [0229] H. A line originating at the intersection of D
and E extending along the horizontal. [0230] I. A line originating
at the midpoint of F and extending upward along the plumb line.
[0231] J. Labels: PI, PT, SS, and LL. [0232] There can be a
vertical plumb line, with a label: "Gravity" [0233] The Sagittal
Alignment Diagram can be oriented such that the plumb line aligns
with the vertical axis of the page. [0234] There can be a matrix of
data: [0235] Row Labels: "LL=", "SS=", "PI=", and "PT=" [0236]
Values can be presented next to each label, in degree units rounded
to the nearest whole number. [0237] For users that are configured
for the "Rothenfluh" method for determining Sagittal Alignment
corrections, the additional following objects can be present in the
Sagittal Alignment Diagram: [0238] There can be a label at the
bottom "PI-LL=", along with the PI-LL Value [0239] There can be
space to show a single triangle icon, either yellow or red, plus
short text, based on whether or not the Sagittal Alignment alert is
activated. See the "Alerts Features" Section for more specification
about the conditions that various alerts become active. [0240]
There can be a label "Lordosis Type X (Roussouly)", wherein the "X"
is the Roussouly Type, and can assume the value 1, 2, 3, or 4. See
the Calculations Features section for more information about the
function to determine the Roussouly Lordosis Type. [0241] For users
that are configured for the "Roussouly" method for determining
Sagittal Alignment corrections, the additional following objects
can be present in the Sagittal Alignment Diagram: [0242] There can
be a label "Lordosis Type X (Roussouly)", wherein the "X" is the
Roussouly Type, and can assume the value 1, 2, 3, or 4. [0243]
There can be a label "Pelvic Tilt" as well as the pelvic tilt value
given in degree units rounded to the nearest whole number. [0244]
There can be space to show a single triangle icon, either yellow or
red, plus short text, horizontally spaced next to the two values
associated with "Lordosis Type" and "Pelvic Tilt" (as described
directly above), and vertically spaced between those two rows. See
the "Alerts Features" Section for more specification about the
conditions that various alerts become active. [0245] A Label that
says "APEX" positioned next to the appropriate vertebral body
label. [NOTE: In some prior designs, this was the "APEX" label plus
an arrow pointing to a vertebral body. This design was abandoned,
as the arrow could confuse the user into thinking that the APEX is
at a certain point within the vertebral body height, as opposed to
simply identifying the vertebral body in which the apex occurs.]
[0246] Additional data elements positioned underneath the "Lordosis
Type X (Roussouly)" label described above: "Total L1-S1
Lordosis=X.degree.", "Upper Lumbar Arc=Y.degree.", and "Lower
Lumbar Arc=Z.degree." [0247] FIGS. 9A-B for the Rothenfluh and
Roussouly versions of the Sagittal Alignment Diagram:
[0248] Main Screen, Left Pane: Disc Space View [0249] The Disc
space view corresponds to the [ACTIVE LEVEL] level (i.e. it
presents data about the [ACTIVE LEVEL] [0250] On the left hand pane
of the widow: there can be four sub-panels: (1) An upper left
sub-panel (for the disc space diagram), (2) an upper right
sub-panel (for the Distance From/To diagram), (3) a middle
sub-panel (for the data table sub-panel), and (4) a lower sub-panel
(for overlays/options. [0251] In the upper left sub-panel, which is
for the Disc Space Diagram, there can be: [0252] A title label
"Disc Space View" [0253] A check box that makes the Disc Space
Diagram visible and un-visible (respectively). This comes defaulted
to visible. [0254] The Disc Space Diagram (the features for the
Disc Space Diagram are given below in a separate dedicated
sub-section below) [0255] In the upper right sub-panel, which is
for the Distance From/To Diagram, there can be: [0256] There can
be: [0257] A label that says "Distance From [DROP DOWN 1] to [DROP
DOWN 2]" [0258] [DROP DOWN 1] system can: Allow users to select
from the list: Current Capture: If [CAPTURE STATUS] is not "No
Capture Yet", else this is ghosted Reference View (may be visible)
Target Construct: if [ACTIVE LEVEL] is selected for fusion,
otherwise this is ghosted/inactive. Prior Captures: if [CAPTURE
STATUS] is "Current Capture with Prior captures", THEN there is a
prior captures section, with the header "Prior Captures", along
with a list of prior captures, as specified in the Status Variable
Features Section (see the end of the [REFERENCE VIEW] section) ELSE
there is only the label "Prior Captures" that is ghosted/inactive
If an line item is selected on [DROP DOWN 2], then that line item
is ghosted on [DROP DOWN 1] (and vice versa) Be defaulted to:
"Current Capture" in the case that the [CAPTURE STATUS] is not "No
Capture Yet" ELSE "Reference View" [0259] [DROP DOWN 2] can have
the same rules as [DROP DOWN 1], except for: Allows users to select
from the list: All items the same as for [DROP DOWN 1], except that
the value (null) can be allowed in [DROP DOWN 2]. Default values
can be: "Target Construct" in the case that the if [ACTIVE LEVEL]
is selected for fusion ELSE null [0260] A checkbox next to the
above-described label, such that checking and unchecking the check
box makes the Distance From/To diagram object visible and
un-visible (respectively). This comes defaulted to visible. [0261]
The Distance From/To Diagram (the features for the Distance From/To
Diagram are given below in a separate dedicated sub-section below)
[0262] In the middle sub-panel, which is for the data table, there
can be: [0263] A Label that says "Dimensions" [0264] A drop down
box with a label saying "Linear Dimension Units", with a drop down
box that is defaulted to the user configured default, and which can
assume the values of millimeters, % Vertebral Body Depth, % Max
Range. [0265] The following columns: Posterior Disc Height, Midline
Disc Height, Anterior Disc Height, Segmental Lordosis, PI-LL [0266]
On the PI-LL column, if there are PI-LL alerts that have been
activated, a yellow or red (as appropriate) alert icon can be
displayed next to the appropriate number. [0267] There can be a row
for Target Construct, Current Capture, and Reference View, so long
as the respective check box in the "Overlays" section is selected.
In the case that the checkbox is not selected, then the row system
cannot appear, and the table will be shorter. [0268] In the case of
Reference View, row heading can be "Ref. View: [VIEW TEXT]". See
the Status Variable features section for more information about the
Reference View variable. [0269] In the bottom sub-panel, which is
for the Overlays and Options, there can be: [0270] A Label that
says "OVERLAYS" [0271] Underneath the "OVERLAYS" label, checkboxes
and icons for: Target Construct, Current Capture, Reference View,
Mobility Ranges, and Gravity (plumb). [0272] For Target Construct,
it can be ghosted/inactive if [ACTIVE LEVEL] is NOT selected for
fusion. [0273] For the Current Capture row, there can be two
configurations: [0274] If [CAPTURE STATUS]="Current Capture with no
prior captures", then there can be a label saying "Current Capture"
(not a drop down). [0275] If [CAPTURE STATUS]="Current Capture with
prior captures", then there can be a drop down, defaulted to the
Current Capture, which draws from the list comprised of the Current
Capture plus the Prior Captures, as described in the Status
Variables Section of this document (see the end of the Reference
View part of that). [0276] If [CAPTURE STATUS]="No capture yet",
the row (including the label, icon, and checkbox) can be ghosted.
[0277] For the Reference View row, there can be a drop down
underneath which has a drop down box that allows the user to select
among the [REFERENCE VIEW] values (See section about the Reference
View in the Status Variable features section of this document for
more details about these potential values) [0278] A Label that says
"OPTIONS" [0279] Underneath the "OPTIONS" label: [0280] A checkbox
that says "Images" such that checking and unchecking the check box
makes the image underlays visible and invisible (respectively).
[0281] Indented from the checkbox above, a set of three radio
buttons with the labels "Target Construct", "Current Capture", and
"Reference View", defaulted to the value specified in user config,
such that the specific image view is switched when the radio button
values change. [0282] Items in the set of three radio buttons
("Target Construct", "Current Capture", and "Reference View") are
ghosted/inactive if the corresponding checkbox in the "OVERLAYS"
section is deselected, and become active when the corresponding
checkbox is selected [0283] A checkbox that says "Labels" [0284]
Checkbox, radio button, and drop down default values can be set as
configured in the user configuration variables. Once a user
selects/deselects checkboxes and radio buttons or changes the value
in dropdowns in this section, those values system can persist if
the user should go to view another level's disc space view, or if
the user goes to another screen and then returns. [0285] The Disc
Space Diagram can be a diagram that, when activated for display,
will occupy the upper left sub-panel of the left pane of the Disc
Space View screen, and system can contain: [0286] A target
construct outlined in blue that is selectably visible (based on the
checkbox value): [0287] A target construct, inferior vertebral
body, positioned such that the superior edge aligns with the
horizon, and that incorporates are "balls" at each of the superior
anterior and superior posterior corners. [0288] A target construct,
superior vertebral body, that incorporates are "balls" at each of
the inferior anterior and inferior posterior corners [0289] The
target construct, superior vertebral body object described above
system can only be visible if the [ACTIVE LEVEL] is selected for
fusion. In all other cases, the object is invisible. [0290] A
capture outlined in red, that is selectively visible (based on the
checkbox value): [0291] A capture, superior vertebral body [0292]
If [CAPTURE STATUS] is equal to "No Capture Yet" the current
capture, superior vertebral body system cannot be displayed. [0293]
If the user has selected a prior capture from "OVERLAYS" Section,
the box should be red, but a different hue that is darker (as
compared to red used for the current capture) [0294] A reference
view outlined in green, that is selectively visible (based on the
checkbox value): [0295] A reference view, superior vertebral body
[0296] A set of min/max mobility range graphic elements that are
selectably visible (based on the checkbox value) [0297] A posterior
mobility range graphic element, which is: [0298] a vertical element
that has a background line that goes through the superior posterior
corner of the target construct, inferior vertebral body, and also
has a vertically oriented elongated rectangle (the long axis
superimposed on the background line) that is sized to represent the
min/max mobility range of the posterior disc height (PDH). [0299]
This element stays fixed in space if/when the user moves or rotates
the target construct, superior vertebral body. [0300] A horizontal
background line that goes through the inferior posterior corner of
the target construct, superior vertebral body, which meets the
vertical element, and then becomes an arrow (on the other side of
the vertical element) pointing to the vertical element. [0301] This
element moves along with the target construct if/when moves or
rotates the target construct, superior vertebral body. [0302] A
vertical anterior mobility range graphic element, which is [0303] a
vertical element that has a background line that goes through the
superior anterior corner of the target construct, inferior
vertebral body, and also has a vertically oriented elongated
rectangle (the long axis superimposed on the background line) that
is sized to represent the min/max mobility range of the anterior
disc height (ADH). [0304] This element stays fixed in space if/when
the user moves or rotates the target construct, superior vertebral
body. [0305] A horizontal background line that goes through the
inferior anterior corner of the target construct, superior
vertebral body, which meets the vertical element, and then becomes
an arrow (on the other side of the vertical element) pointing to
the vertical element. [0306] This element moves along with the
target construct if/when moves or rotates the target construct,
superior vertebral body. [0307] A horizontal offset mobility range
graphic element, which is: [0308] a horizontal element that has a
background line that goes through the superior posterior corner of
the target construct, inferior vertebral body, and also has a
horizontally oriented elongated rectangle (the long axis
superimposed on the background line) that is sized to represent the
min/max mobility range of the offset. [0309] This element stays
fixed in space if/when the user moves or rotates the target
construct, superior vertebral body. [0310] A vertical background
line that goes through the inferior posterior corner of the target
construct, superior vertebral body, which meets the horizontal
element, and then becomes an arrow (on the other side of the
horizontal element) pointing to the horizontal element. [0311] This
element moves along with the target construct if/when moves or
rotates the target construct, superior vertebral body. [0312] A
plumb line gravity indicator arrow that is selectively visible
(based on the checkbox value), with an arrow endpoint that is
co-located with the midpoint of the inferior edge of the target
construct, superior vertebral body. [0313] Background images
(underlays) that are selectively visible (based on the checkbox
value). User can select to have background images underlays be
visible or invisible. [0314] Users can further can specify to
select from a set of three radio buttons with labels "Target
Construct", "Current Capture", and "Reference Views". [0315] If
[CAPTURE STATUS]="No Capture Yet", then the "Current Capture" can
be ghosted/inactive. [0316] If the [ACTIVE LEVEL] is not selected
for fusion, then the "Target Construct" is ghosted/inactive [0317]
If Reference View or Current Capture are selected, the appropriate
image is displayed. These Images (all reference views and the
current capture) can have been cropped to the [ACTIVE LEVEL]:
[0318] Find the leftmost, rightmost, topmost, and bottom most
coordinates from the 8 points (4 for superior vertebral body, 4 for
inferior vertebral body. [0319] Extend 10% in each direction.
[Note: This is a guess. This needs to be played with a bit to see
what looks the best.] [0320] Crop a square region around the two
vertebral bodies, oriented to align the superior edge of the target
construct, inferior vertebral body. (note 1: If it is not too
processor intensive, smooth/fade the borders. Note 2: the cropped
regions should be the same across views in terms of the cropping
relative to the inferior vertebral body of a level, so that
switching the image to view does not change the shape of the image
underlay) [0321] In the case the user has selected Target
Construct, a view is rendered: [0322] Use as a base image the
cropped standing neutral uncontrolled view. In the case that a
current capture has occurred, use as a base image the cropped
current capture image. [0323] Cut the image along the inferior edge
of the superior vertebral body. [0324] Rotate and translate the
upper section (above the cut) to position it where the target
construct is positioned. [0325] Allow the upper section to
overwrite the lower section of the images. [0326] If new space is
created, that space can be filled with pixels colored to the
average color across the image. [0327] Re-Apply the cropping
parameters [0328] In the case the [ACTIVE LEVEL] is newly selected
for fusion surgery AND from the User Config the default image is
set to "Target Construct", then switch the image being viewed to
Target Construct (and update the radio button) from whatever its
current value is. [0329] In the case the status variable [CAPTURE
STATUS] changes from "No Capture Yet" to any other value AND from
the User Config the default image is set to "Current Capture", then
switch the image being viewed to Current Capture (and update the
radio button) from whatever its current value is. [0330] The
following actions can be available to the user when moving the
mouse over specific regions of the Disc Space Diagram: [0331] The
Target Construct, Superior vertebral body can be able to be grabbed
and moved/rotated: [0332] Grab/Drag the inferior edge of the target
construct, superior vertebral body, and the user can be allowed to
translate the target construct, superior vertebral body up/down and
left/right. [0333] Grab/Rotate the "balls" of the inferior edge of
the target construct, superior vertebral body, and the user can be
able to change the angle of the target construct. [0334] Max range
of motion allowed for Grab/Drag and Grab/Rotate actions: All points
of the target construct, superior vertebral body system can stay
within a rectangle with horizontal edges parallel to the superior
edge of the target construct, inferior vertebral body, defined by:
[0335] Left/right: Max of [leftmost/rightmost points (among the 8
points for each view) across all Reference views, extending 10%
beyond in each direction] OR 50% of vertebral body depth on either
side [0336] Up: 200% of Inferior vertebral body midline height
above the horizontal superior edge of the Target Construct,
inferior vertebral body. [0337] Down: Minimum of the cropped
regions across all Reference Views [0338] In the case that: (1)
image underlays are selected to be visible, and (2) the target
construct is selected as the view to display;
[0339] then upon any update to the position/angle of the target
construct, superior vertebral body, the target construct view needs
to be re-rendered based on the updated location/angle. [0340] This
update also system can occur whenever the target construct geometry
is updated by any other mechanism (see Calculation Features for all
of the situations in which the target construct geometry is
changed). [0341] In the case that the Distance From/To diagram is
visible, then upon any update to the position/angle of the target
construct, superior vertebral body, the Distance From/To Diagram
view needs to be re-rendered based on the updated location/angle.
[0342] Click the Plumb line gravity indicator arrow, and the Disc
Space Diagram can be rotated such that the plumb line aligns with
the vertical axis of the screen. Clicking the plumb line again will
re-orient the Disc Space Diagram such that the target construct,
inferior vertebral body's superior edge is parallel to the
horizontal axis of the screen. [0343] The Distance From/To Diagram
can be a diagram that, when activated for display, will occupy the
upper right sub-panel of the left pane of the Disc Space View
screen, and system can contain: [0344] Three boxes can be
displayed: The "from" construct, inferior vertebral body; the
"from" construct, superior vertebral body, and the "to" construct,
superior vertebral body (filled in and on top of the other boxes)
[0345] These boxes can be vertically positioned such that they
align with the Disc space View graph to the left. [0346] Each box
system can assume the appropriate color as already defined
(blue=target, red=current capture, green=reference). For a prior
capture, the box should be red, but a different hue that is darker
(as compared to red used for the current capture). [0347] In the
case that [DROP DOWN 2] is NOT null, then three red arrow objects
(and associated text and alert icons) can be placed on the diagram,
relative to box associated with the "from" construct, superior
vertebral body. [0348] Each of the arrows can be sized commensurate
with the associated value [0349] Each associated value can be
displayed near the arrow in the format "#.#mm" [0350] There can be:
[0351] A posterior height arrow [0352] In the case that the value
is an upward (positive) or zero value, the arrow can be positioned
relative to the posterior inferior corner of the current capture
box. [0353] In the case that the value is a downward (negative
value), the arrow can be positioned relative to the posterior
superior corner of the current capture box. [0354] In the case that
an alert SP or PSO (or both) is active, there can be the
appropriate alert icon displayed next to the value text associated
with the posterior height arrow. [0355] An anterior height arrow
[0356] In the case that the value is an upward (positive) or zero
value, the arrow can be positioned relative to the anterior
inferior corner of the current capture box. [0357] In the case that
the value is a downward (negative value), the arrow can be
positioned relative to the anterior superior corner of the current
capture box. [0358] In the case that an ALL alert is active, there
can be the appropriate alert icon displayed next to the value text
associated with the anterior height arrow. [0359] An offset arrow
[0360] In the case that the value is a rightward (positive) or zero
value, the arrow can be positioned relative to the posterior
inferior corner of the current capture box. [0361] In the case that
the value is a leftward (negative value), the arrow can be
positioned relative to the anterior inferior corner of the current
capture box. [0362] A rotation indicator icon along with a text
label showing the additional lordosis [0363] The additional
lordosis value can be displayed near the icon in the format
"+#.degree." or "-#.degree." as appropriate based on the value.
[0364] The icon can be a counterclockwise rotation icon in the case
that the additional lordosis value is positive or zero. [0365] The
icon can be a clockwise rotation icon in the case that the
additional lordosis value is negative.
[0366] Main Screen, Left Pane: View Lumbar Images [0367] There can
be a title label: "Reference View", with a drop down box
referencing the REFERENCE VIEW variable. [0368] There can be a
space on the page for the image to reside in its native format
(Optimized for 1 k.times.1 k pixels, but able to accept up to 2
k.times.1.5 k). [0369] There can be a gravity Indicator, comprising
an arrow and a label "Gravity" next to the image, that is
selectably visible (based on the checkbox), but also that system
can only be visible if the [REFERENCE VIEW] has gravity data
(otherwise this object is invisible). [0370] Underneath the image,
there can be the following user input sections: [0371] A column
title label "ORIENTATION", under which is a set of radio buttons
corresponding to the labels "Gravity", "Most Recent Capture",
"Native" or "LX Superior Edge" [0372] "LX" can be the vertebral
body label corresponding to the ACTIVE LEVEL. [0373] The "LX
Superior Edge" item (Label+radio button) can be invisible and
inactive if there is ACTIVE LEVEL=null. [0374] The "Most Recent
Capture" item (Label+radio button) can be inactive/ghosted if the
[CAPTURE STATUS]="No Capture Yet" [0375] The "Gravity" item
(Label+radio button) be inactive/ghosted if the [REFERENCE VIEW]
does NOT contain gravity data. [0376] This set of radio buttons can
be defaulted based on data from user config, and whenever a new
value is selected, the image and the gravity indicator get rotated
as appropriate. [0377] A column title label "SELECT VIEW", under
which is a set of radio buttons corresponding to the labels
"LX-LY", "LY-LZ", or "Pelvic View" [0378] The two elements "LX-LY"
and "LY-LZ" appear in this list only if there are both superior and
inferior views associated with a specific REFERENCE VIEW. If there
is only one view that contains L1-S1, then there will only be one
label "L1-S1". [0379] The "Pelvic View" item will only appear if
REFERENCE VIEW=Standing uncontrolled neutral. [0380] This section
(the column titled "SELECT VIEW") can be invisible if there is only
one item (i.e. "L1-S1", meaning no superior/inferior views and no
pelvic view). [0381] A column title label "OPTIONS", under which is
a set of check boxes corresponding to the labels "Gravity",
"Labels" and "Templates" [0382] Selecting/Deselecting the "Gravity"
checkbox makes the gravity indicator described above toggle between
visible/invisible (respectively). [0383] The "Gravity" item
(Label+checkbox) be inactive/ghosted if the [REFERENCE VIEW] does
NOT have gravity data. [0384] Selecting/Deselecting "Labels" makes
the vertebral body label overlays on the image toggle between
visible/invisible (respectively). [0385] Selecting/Deselecting
"Templates" makes the vertebral body template overlays on the image
toggle between visible/invisible (respectively). [0386] Templates
get created via a function that creates corner and cross hairs line
coordinates, provided a 4 (x,y) vertebral body position corner
points. [This function can be achieved using Matlab from
MathWorks.RTM. However, other languages can be used without
departing from the scope of the disclosure.].
[0387] Capture Screen [0388] The Capture Screen can be
substantially the same as the Main Screen. Whereas the Main Page
has three variants on the left pane and two on the right pane, the
Capture Screen represents a variant of the left and right pane can
be displayed together. [0389] The left pane system can: Contain the
following page elements: [0390] A title label "Fluoro View" [0391]
Underneath title, there can be set of five radio buttons, with
labels "L1/L2" "L5/S1", arranged in a row, with that row header
labeled "Level to Capture", and which are linked to the value of
[MARKUP LEVEL] [0392] This can be defaulted to [ACTIVE LEVEL], and
can be changeable by the user. [0393] In the case that [ACTIVE
LEVEL]=null, then this row of radio buttons is active, but none are
selected. [0394] There can be an Image Section wherein image system
can reside in its native format (Optimized for 1 k.times.1 k
pixels, but able to accept up to 2 k.times.1.5 k). [0395] There can
be a set of labels and radio buttons, this set of labels and radio
buttons being labeled "VIEW:" [0396] "Live Fluoro Feed", when
selected, system can show in the image space the live fluoro feed
coming from the image capture system. [0397] "Live Fluoro Feed" is
the default value. Until a capture has occurred, this set of radio
buttons can only have the value "Live Fluoro Feed" [0398] "Current
Capture", when selected, system can show the image stored as the
current capture. [0399] If [MARKUP STATUS] is equal to Step 0 to
Step 4 (i.e. not step 5), then the previously marked up corners can
be visible on the image, and available for editing by the user.
[0400] In the case that a [CAPTURE STATUS] is set to "Current
Capture with Prior captures", then there system can also be the
item "Prior Capture" visible, which can be positioned next to a
drop down list populated by a list of the prior captures. The
specific features for the list of prior captures for the drop down
list can be found in the section about the status variables
[REFERENCE VIEW] and [COMPARE PRIOR MARKUP VIEW] from the Status
Variable Features Section of this document. [0401] A Button that
says "Grab Frame", that can be active only when the set of radio
buttons above is set to "Live Fluoro Feed". When this button is
pressed: [0402] The image Section changes from a video feed to a
freeze frame of the image that is potentially going to be saved.
[0403] A check is done on the status variable [CALIBRATE STATUS].
[0404] If FALSE, then a pop-up can be displayed to the user. [0405]
The label can be displayed: "To proceed with this image capture, a
Grid calibration image can be captured as well, which has not
occurred yet. Press "OK" to capture the calibration image right
now. Press "Cancel" to cancel the current video capture action and
lose the image data that is presently displayed" [0406] There can
be an OK and cancel button. [0407] Pressing OK system can pull up
the Calibrate Modal Window. [0408] Pressing Cancel system can: (1)
close the pop-up, (2) resume the live video feed in the Image
Section, and (3) return the user to the Capture Screen [0409] If
TRUE the take no action [0410] An instance of the [CAPTURE DATA]
dataset can be created, and the current live fluoro feed image gets
saved as the image within that dataset. [0411] The correction
matrix can be accessed from the [CALIBRATE DATA] data structure,
and then can be used to reseal the image to correct for distortion.
[0412] the radio button can be changed to "Current Capture" from
"Live Fluoro Feed" [0413] the "Grab Frame" images can become
ghosted and inactive. [0414] The right pane system can contain:
[0415] A Title at the top "STATUS: [Status Text]". [Status Text]=
[0416] "Capture and markup complete" In the case that [MARKUP
STATUS]=Step 5 and [MARKUP SAVE STATUS]="Saved" [0417] "Markup in
process" In the case that [MARKUP STATUS]=Step 1 to Step 4 [0418]
"Need to Save or Cancel Changes" In the case that [MARKUP
STATUS]=Step 5 and [MARKUP SAVE STATUS]="Unsaved" [0419] "Needs
markup (capture complete)" In the case that [MARKUP STATUS]=Step 0
[0420] An Area for Directions, which is visible only when the
[Status Text]="Needs markup (capture complete)." Or "markup in
process" [0421] A Text Box Labeled "Markup Directions" in which
Direction text is displayed. [0422] A Markup Diagram, which can
assume one of five configurations [0423] For steps 1, 2, 4, and 5,
the Markup Diagram assumes the form shown in FIG. 12 (green items
are instructions, not part of the diagram). [0424] The red dot is
placed at the appropriate corner (Step 1=POST/INF, Step 2=ANT/INF,
Step 4=POST/SUP, Step 5=ANT/SUP) [0425] In the boxes, the text
label system can say "SUP." and "INF" if [MARKUP
LEVEL]="Unspecified". Otherwise, they say "LY" and "LX"
respectively, where "LY" is the label of the superior vertebral
body of the level and "LX" is the label of the inferior vertebral
body of the level. See, FIG. 10. [0426] For step 3, the Markup
Diagram can be a row of 6 radio buttons, with labels: L1, L2, L3,
L4, L5, S1.). [0427] A set of buttons "Cancel" and "Save", which
can be active whenever [MARKUP SAVE STATUS] is set to "Unsaved"
[0428] Upon Pressing "Save", the [MARKUP POINTS], [MARKUP LEVEL]
can be saved and the [MARKUP SAVE STATUS] can be set to "SAVED"
[0429] Upon Pressing "Cancel", none of the changes that have been
made to data since arriving at the "Capture" screen can be saved.
[0430] Upon pressing either, active control can be switched from
Capture Screen back to Main Screen. [0431] A Compare to Prior Spine
Markup Area, which can be visible whenever the [MARKUP LEVEL] is
not "Unspecified" [0432] In the user configuration, a default value
is assigned for default view for Compare to Prior Spine Markup.
There can be a label "Compare to Prior Spine Markup", next to a
drop down box that allows the user to change the value the variable
[COMPARE PRIOR MARKUP VIEW]. See the Status Variable Features for
more details about this variable. [0433] The specified image can be
accessed, and can be cropped to the Level specified by [MARKUP
LEVEL] according to the cropping features provided in the "Main
Screen, Left Pane: Disc Space View" Section of this document.
[0434] The cropped view can be displayed, with the four fiducials
associated with the levels placed on top. [0435] In the case that
[MARKUP STATUS] is less than Step 3 or higher, the view can be
displayed such that the view is rotated to align the Inferior edge
of the disc space with the current capture. [0436] Else, the view
can be displayed in its native orientation. [0437] In the case that
the "VIEW:" radio buttons are set to "Current Capture" OR "Prior
capture", AND the associated [MARKUP STATUS]=Step 0 through Step 4;
then [0438] On the left pane the 7 tabs at the top, and on the
right pane the other two tabs at the top ("Surgery Summary" and
"Level Summary") system can all be ghosted/inactive [0439] The
Image Section of the Capture screen system can: [0440] Display
fiducial markers on the images. Fiducial markers are objects placed
in the field of view as a point of reference. The number and
composition of the fiducials can be based on the [MARKUP STATUS]
variable: [0441] Step 1: 1_INF_VERT_POST_SUP_CORNER [0442] Step 2:
Add 2_INF_VERT_ANT_SUP_CORNER, and create a line with that as an
endpoint and the other one at 2_INF_VERT_ANT_SUP_CORNER [0443] Step
3: Add 3_SUP_VERT_POST_INF_CORNER [0444] Step 4: Add
4_SUP_VERT_ANT_INF_CORNER, and create a line with that as an
endpoint and the other one at 3_SUP_VERT_POST_INF_CORNER [0445]
Highlight a previously-placed fiducial as a user moves the mouse
over it, allowing the following actions upon a click: [0446] Enable
the user to edit the location of the fiducials on the image by
click/Dragging them. As they are click/dragged, if there is a line
connecting a fiducial to another fiducial, the line length/angle
changes as the other fiducial stays fixed [0447] Enable the user to
edit the location of lines that connect the fiducials by
click/dragging them. As they are click/dragged, the line and both
endpoints move in lock step. [0448] The user can be initiated into
a workflow that progresses from a starting point defined by the
current [MARKUP STATUS], and that terminates upon the user clicking
"SAVE", or "CANCEL" [0449] Step 0: [0450] Configuration of the Area
for Directions [0451] Direction text: If [MARKUP LEVEL] is set to a
level (i.e. not "unspecified"): "Mark the posterior corner of
[LX]". "LX"=the label of the inferior vertebral body of [MARKUP
LEVEL] If [MARKUP LEVEL] is "Unspecified": "Mark the Posterior
corner of the inferior vertebral body" [0452] Markup Diagram
description: Red dot at POST/INF corner of disc space [0453] Step
1: [MARKUP STATUS] system can increment from Step 0 to Step 1 when
the user selects a point on the Image Section of the Capture Page.
[0454] [MARKUP POINT] can be saved (1_INF_VERT_POST_SUP_CORNER)
[0455] [MARKUP SAVE STATUS] can be set to "Unsaved" [0456] A line
can be created, with an endpoint at (1_INF_VERT_POST_SUP_CORNER)
and with another endpoint at the current cursor location. As the
user moves the mouse, the line changes in angle and length, and if
the user moves mouse off the Image the line stops at the edge of
the image but goes in a direction where the mouse is. [0457]
Configuration of the Area for Directions [0458] Direction text: If
[MARKUP LEVEL] is set to a level (i.e. not "unspecified"): "Mark
the anterior corner of [LX]". "LX"=the label of the inferior
vertebral body of [MARKUP LEVEL] If [MARKUP LEVEL] is
"Unspecified": "Mark the anterior corner of the inferior vertebral
body" [0459] Markup Diagram description: Red dot at ANT/INF corner
of disc space [0460] Step 2-3: [MARKUP STATUS] system can increment
from Step 1 to Step 2 when the user selects a point on the Image
Section of the Capture Page. [0461] [MARKUP POINT] can be saved
(2_INF_VERT_ANT_SUP_CORNER) [0462] A line can be placed, with
endpoints at (1_INF_VERT_POST_SUP_CORNER) and
(2_INF_VERT_ANT_SUP_CORNER). [0463] The cursor system can resume
normal functions. [0464] [MARKUP SAVE STATUS] can be set to
"Unsaved" [0465] In the case that If [MARKUP LEVEL] is set to a
level (i.e. not "unspecified"): [0466] An additional step is added:
Direction text: "Label the inferior vertebral body" Markup Diagram
description: Display a row of 6 radio buttons, with labels: L1, L2,
L3, L4, L5, S1. Selecting a radio button here sets the [MARKUP
LEVEL] to the appropriate level The radio buttons at the top of the
left pane of the Capture window, which are synchronized to the
[MARKUP LEVEL] Variable, can be updated as appropriate. Upon either
selecting a radio button here associated with the inferior
vertebral body of a level, or selecting a level from the radio
buttons at the top of the left pane of the Capture window, the
[MARKUP STATUS] system can increment from Step 2 to Step 3 [0467]
Else ([MARKUP LEVEL] is NOT "Unspecified"), [MARKUP STATUS] System
can increment from Step 2 to Step 3 [0468] Step 3: Configuration of
the Area for Directions [0469] Direction text: "Mark the posterior
corner of [LY]". "LY"=the label of the superior vertebral body of
[MARKUP LEVEL] [0470] Markup Diagram description: Red dot at
POST/SUP corner of disc space [0471] Step 4: [MARKUP STATUS] system
can increment from Step 3 to Step 4 when the user selects a point
on the Image Section of the Capture Page. [0472] [MARKUP POINT] can
be saved (3_SUP_VERT_POST_INF_CORNER) [0473] A line can be created,
with an endpoint at (3_SUP_VERT_POST_INF_CORNER) and with another
endpoint at the current cursor location. As the user moves the
mouse, the line changes in angle and length, and if the user moves
mouse off the Image the line stops at the edge of the image but
goes in a direction where the mouse is. [0474] [MARKUP SAVE STATUS]
can be set to "Unsaved" [0475] Configuration of the Area for
Directions [0476] Direction text: "Mark the anterior corner of
[LY]". "LY"=the label of the superior vertebral body of [MARKUP
LEVEL] [0477] Markup Diagram description: Red dot at ANT/SUP corner
of disc space [0478] Step 5: [MARKUP STATUS] system can increment
from Step 4 to Step 5 when the user selects a point on the Image
Section of the Capture Page. [0479] [MARKUP POINT] can be saved
(4_SUP_VERT_ANT_INF_CORNER) [0480] A line can be placed, with
endpoints at (3_SUP_VERT_POST_INF_CORNER) and
(4_SUP_VERT_ANT_INF_CORNER). [0481] The cursor system can resume
normal functions. [0482] [MARKUP SAVE STATUS] can be set to
"Unsaved" [0483] Once the above actions have occurred, the user can
either press "Save" or "Cancel" (or "Exit" or "Load Patient") to
progress. [0484] In the case that the "VIEW:" radio buttons are set
to "Current Capture" OR "Prior capture" and the associated [MARKUP
STATUS]=Step 5 [0485] The Image Section of the Capture screen
system can: [0486] Display fiducials on the images, The number and
composition of which can be based on the [MARKUP STATUS] variable:
[0487] Step 1: 1_INF_VERT_POST_SUP_CORNER [0488] Step 2: Add
2_INF_VERT_ANT_SUP_CORNER, and create a line with that as an
endpoint and the other one at 2_INF_VERT_ANT_SUP_CORNER [0489] Step
3: Add 3_SUP_VERT_POST_INF_CORNER [0490] Step 4: Add
4_SUP_VERT_ANT_INF_CORNER, and create a line with that as an
endpoint and the other one at 3_SUP_VERT_POST_INF_CORNER [0491]
Highlight a previously-placed fiducial whenever a user moves the
mouse over it, allowing the following actions upon a click: [0492]
Enable the user to edit the location of the fiducials on the image
by click/Dragging them. As they are click/dragged, if there is a
line connecting a fiducial to another fiducial, the line
length/angle changes as the other fiducial stays fixed [0493]
Enable the user to edit the location of lines that connect the
fiducials by click/dragging them. As they are click/dragged, the
line and both endpoints move in lock step. [0494] Whenever any of
the [MARKUP POINTS] are changed by the user making edits to the
location of fiducials overlaid on the image, the [MARKUP SAVE
STATUS] is set to "Unsaved" [0495] In the case that [MARKUP SAVE
STATUS] is set to "UNSAVED" [0496] On the left pane the 7 tabs at
the top, and on the right pane the other two tabs at the top
("Surgery Summary" and "Level Summary") system can all be
ghosted/inactive. [0497] The user can either press "Save" or
"Cancel" (or "Exit" or "Load Patient") to progress.
[0498] Modal Windows (Accessible Via the Main Screen and Capture
Screen) [0499] Modal windows can be accessible via the Main Screen
and Capture Screen. [0500] There can be the following modal
windows: [0501] Load New Patient [0502] Load Previous Session
[0503] Edit Midline Disc Height (A1) [0504] Edit Offset (A2) [0505]
Edit Lordosis (A3) [0506] Lordosis Distribution Calculations
(Routhenfluh) (B1) [0507] Lordosis Distribution Calculations
(Roussouly) (B2) [0508] Edit Correction for Anticipated Subsidence
(C1) [0509] Calibrate (D) [0510] The modal windows, when accessed,
can be the only active window, and the previous active window is
greyed out, unless/until the user either takes an action within the
window that closes it or the user clicks on a greyed out portion of
the previous active window, both of which have the effect of
closing the modal window. [0511] Load New Patient [0512] There can
be a title "Load a new patient to start a session" [0513] There can
be a button "Re-Open Previous Session" which, when pressed, system
can close the Load New Patient modal window and open the Load
Previous Session modal window. [0514] There can be a means for the
user to select a patient file for loading from a removable media
[0515] The list of files to select from system can include FIRST
NAME/LAST NAME initial and date of birth (DOB) [0516] List items
can be sorted with newest first [0517] Pressing Select system can
initiate a load of that patient file. [0518] The system can copy
files [0519] The system can decrypt the files [0520] The system can
initialize a user session based on the contents of the files [0521]
The system can present a status window (See Load New
Patient--SUBWINDOW2) to the user to inform the user of the status
of the process of initializing the user session. This window system
can also allow the user to cancel the load, which returns the user
to the Load New Patient modal window [0522] Once loaded and
initialized, the user can be returned to the Main Screen. [0523] If
possible, the system can, [0524] prior to initiating a potentially
lengthy load and initialization cycle, first read and decrypt the
patient's full name, DOB, and study date, [0525] Present said data
to the user in a pop-up (See Load New Patient-SUBWINDOW1) wherein
the user confirms or cancels the load operation. If user confirms
the patient data, the: a check is done on the user type, and for OR
ADMIN user types: a list of surgeons pops-up, and the OR Admin user
selects the surgeon who is running the case from the list of all
SURGEON users on the system. Once this gets set, a check is done to
see if the Surgeon's user has ever been through the click-through
agreement in the User Configuration pages. If so, no action. If
not, the user is instructed to log off and have the surgeon user
login and accept the configuration click through, and the patient
is not loaded, active control goes back to the Load New Patient
modal window. active control goes to the initialization status
window if still loading/initializing, or active control goes to the
Main Screen if initialization process is complete. If the user
presses cancel, active control goes back to the Load New Patient
modal window. [0526] The more lengthy full load and initialization
operations can begin once the pop-up has been popped up (i.e. while
the user is being presented with SUBWINDOW 1 and taking the time to
react to it, the system in the background is completing the
load/initialize operation). [0527] There can be a "Cancel" Button,
which system can close the Load New Patient modal window and Return
the user to the Screen from which the user came. [0528] Load
Previous Session [0529] There can be a title "Re-Open a Previous
Session" [0530] There can be a means for the user to select a
patient file for loading from a repository on the computers fixed
media (hard drive) that contains previously stored user sessions.
[0531] The list of files to select from system can include: First
name, Last Name, DOB, Date of Study, Date of prior session [0532]
List items can be sorted with newest first (with respect to the
date of prior session) [0533] The list of files to select from is
determined by: [0534] For SURGEON users, whether or not the
site-level parameter is set that allows surgeons to view data from
other surgeons at the same site. [0535] For ADMIN users, all
patients at a given site. [0536] Pressing Select system can
initiate a load of the specified session files. [0537] The system
can initialize a user session based on the contents of the files
such that it represented the last state of the user session data
prior to the last exit action that closed it. [0538] The system can
present a status window (See Load New Patient-SUBWINDOW2) to the
user to inform the user of the status of the process of
initializing the user session. This window system can also allow
the user to cancel the load, which returns the user to the Load
Previous Session modal window [0539] Once loaded and initialized,
the user can be returned to the Main Screen. [0540] There can be a
"Cancel" Button, which system can close the Load Previous Session
modal window and Return the user to the Screen from which the user
came. [0541] Edit Midline Disc Height (A1), Edit Offset (A2), Edit
Lordosis (A3) [0542] Users can be able to access these pages in one
of two ways: [0543] There is a minimum number of levels needed to
calculate an average Disc Height, Offset, and Lordosis that is part
of the User configuration. Whenever the user attempts to select a
level for exclusion such that the total number of level not
selected for fusion goes below this minimum, then this can be
allowed, but this window can be popped up. [0544] If the user hits
the "edit disc height", "edit offset", or "edit lordosis" buttons
[0545] Edit Midline Disc Height (A1) and Edit Offset (A2) are
nearly identical, and are described in the same section (with
differences identified). [0546] There can be a title "Edit Midline
Disc Height" or "Edit Offset". [0547] There can be instructions:
"Adjust the [Midline Disc Height/Offset] by selecting/deselecting
levels for exclusion, or by directly adjusting the value on the
edit box below. The column on the right allows each level to be set
separately." [0548] There can be a matrix of data and objects:
[0549] There can be five rows, one for each level "L1/L2" through
"L5/S1" [0550] There can be five columns" [0551] A first column
with header label "Excluded?", and a column of checkboxes that are
linked with the check boxes on the Surgery Summary Object (from the
Main Screen) [0552] A second column with header label "MIDLINE DISC
HEIGHT (from system)" in the case of Midline Disc Height (A1)
window; header label "Offset (from the vertebral motion analysis)"
in the case of Edit Offset (A2) window a column of millimeter
values (#.#) [0553] A third column labeled "Data for Average
Calculation" with the values from the previous column, excluding
those that which are selected in the first column. Underneath the
third column, there can be an edit box with up/down increment
buttons (#.#mm). The value can be defaulted to the computed average
(after exclusions). Upon a user edit to the value in this edit box,
all of the values in the edit boxes in the fifth column system can
change to the new edited value. To the left of that edit box, there
can be the label "Average After Exclusions". Underneath the edit
box and label above, there can be another row of data There can be
a label directly below the label "Average After Exclusions" that
system can say "Computed value" There can be the average value from
that column displayed (#.#mm), which is the average of the
non-excluded values, directly below the edit box. [0554] A fourth
column with header label "Level Selected for Fusion?", and a column
of checkboxes that are linked with the check boxes on the Surgery
Summary Object (from the Main Screen) and also in the tabs on the
left side of the Main Page. [0555] A fifth columns column with:
header label "MIDLINE DISC HEIGHT" for Midline Disc Height (A1)
window; header label "Offset" for Edit Offset (A2) window For those
levels that are selected for fusion, a column of edit boxes with
up/down increment buttons. Each of the edit boxes can be
independently editable, and when users make edits to any of these
edit boxes, it has no effect on the value of the edit box
underneath the third column. [0556] There can be a "Restore
Default" Button that can be visible whenever the value of the Disc
Height or Offset status variable [CHECKBOX COLUMNS ACTIVE] is
FALSE. [0557] Clicking the restore default values will set all
values back to the computed average value (after exclusions), and
set the [CHECKBOX COLUMNS ACTIVE] to true. [0558] There can be Save
button, which system can save the changes made since the modal
window has been active, then close the window and return control to
the referring page. [0559] There can be Cancel button, which system
can close the window and return control to the referring page.
[0560] In the case that the current number of non-excluded levels
is below the minimum value specified in the User Config: [0561]
Alert text system can appear, underneath the first column "Too many
levels are excluded. Your minimum is at least X non-excluded
levels. You can deselect a level to proceed." [0562] The Save
button can be ghosted and inactive [0563] If the user clicks
"Cancel", then all of the edits made since the modal window was
popped up get undone. [0564] In the case that the modal window had
been popped up by the user's selection of a level for exclusion
that resulted in the total number of non-excluded levels to go
below the minimum value set in user config, the level that had been
selected for exclusion to prompt the pop-up of the modal window is
deselected. [0565] Edit Lordosis (A3) is described below: [0566]
There can be a title "Edit Target Segmental Lordosis". [0567] There
can be instructions: "The target segmental lordosis calculations
are Shown Below. The model can be adjusted by adjusting the levels
excluded from the lordosis model." [0568] There can be a matrix of
data and objects: [0569] There can be five rows, one for each level
"L1/L2" through "L5/S1" [0570] There can be four columns on the
left have of the window [0571] A first column with header label
"Excluded?", and a column of checkboxes that are linked with the
check boxes on the Surgery Summary Object (from the Main Screen)
[0572] A second column with header label "A. Segmental Lordosis
(From vertebral motion analysis)" plus a column of degree values
(#.degree.) [0573] A third column with header label "B.
DISTRIBUTION (from Config)" plus a column of percent values (#%).
There can be a [0574] A fourth column labeled "QUOTIENT: % PER
DEGREE (Calc, A/B)" with the values from the previous column,
excluding those that are selected in the first column. Underneath
the fourth column, is the average of the column (#.#) after
exclusions, with a label to the left that says "C. Average=".
[0575] Above the four columns is a label "Step 1: Determine average
degrees per percent contribution to lordosis for non-excluded
levels" [0576] There can be three columns on the right half of the
window, such that the rows continue to align from the matrix of
data. [0577] A first column with header label "Level Selected for
Fusion?", and a column of checkboxes that are linked with the check
boxes on the Surgery Summary Object (from the Main Screen) and also
in the tabs on the left side of the Main Page. [0578] A second
column with header label "D. TARGET LORDOSIS (calc, B*C)" and a
column of degree values (#.degree.), which system can only contain
values for those rows with a check in the checkbox in the "Level
Selected for Fusion?" column of checkboxes. [0579] A third column
with header label "CHANGE FROM VERTEBRAL MOTION ANALYSIS (calc,
D-A)" plus, for those levels that are selected for fusion, a column
of degree change values (+#.degree. or -#.degree.). Underneath the
third column is the sum of the column above given as a degree
change value (+#.degree. or -#.degree.), with a label to the left
that says "Sum=" [0580] Above the three columns is a label "Step 2:
For all levels selected for fusion, project target lordosis based
on an adjusted distribution function." [0581] There can be Save
button, which system can save the changes made since the modal
window has been active, then close the window and return control to
the referring page [0582] There can be Cancel button, which system
can close the window and return control to the referring page.
[0583] In the case that the current number of non-excluded levels
is below the minimum value specified in the User Config: [0584]
Alert text system can appear, underneath the first column "Too many
levels are excluded. Your minimum is at least X non-excluded
levels. You can deselect a level to proceed." [0585] The Save
button can be ghosted and inactive [0586] If the user clicks
"Cancel", then all of the edits made since the modal window was
popped up get undone. [0587] In the case that the modal window had
been popped up by the user's selection of a level for exclusion
that resulted in the total number of non-excluded levels to go
below the minimum value set in user config., the level that had
been selected for exclusion to prompt the pop-up of the modal
window is deselected. [0588] Lordosis Distribution Calculations
(Routhenfluh) (B1) [0589] There can be a title "Calculations:
Allocating additional lordosis across levels". [0590] There can be
instructions: "The total additional lordosis, as well as the
additional segmental lordosis by level, can be directly adjusted."
[0591] There can be a matrix of data and objects: [0592] There can
be five rows, one for each level "L1/L2" through "L5/S1" [0593]
There can be four columns [0594] A first column with header label
"Level Selected for Fusion?", and a column of checkboxes that are
linked with the check boxes on the Surgery Summary Object (from the
Main Screen) and also in the tabs on the left side of the Main
Page. [0595] A second column with header label "DISTRIBUTION (from
Config)" plus a column of percent values (#%). Underneath this
column there is a label ".SIGMA..apprxeq.100%" (note curvy equal
sign). [0596] A Third column with header label "A. DISTRIBUTION
(Adjusted)" plus a column of percent values (#%), excluding values
from rows that are not selected for fusion, and normalized such
that the sum of all non-excluded levels can be 100%. Underneath
this column there is a label ".SIGMA.=100%" (note normal equal
sign), and under that label another label "The distribution
function is adjusted so that the sum of levels selected for fusion
is 100%." [0597] A Fourth column with header label "ADDITIONAL
SEGMENTAL LORDOSIS (calc, A*B)" plus two sub-columns, with each
sub-column only containing data for those levels that are selected
for fusion:
[0598] the first with sub-column header label "Computed value" and
a column of degree change values (+#.degree. and -#.degree.) [0599]
the second with sub-column header label "User-Edited Value" a
column of Edit boxes with up/down increment buttons, defaulted to
the computed value, and containing degree change values (+#.degree.
and -#.degree.). Changing the value of any of these edit boxes
system can change the value of the edit box underneath the fourth
column, second sub-column. [0600] Underneath the Fourth column:
There can be a degree change value (+#.degree. and -#.degree.)
under the first sub-column of the fourth column that represents the
sum of the values displayed in the columns above (which system
cannot include the excluded levels). To the left of that value
there can be a label "B. ADDITIONAL LORDOSIS" [0601] There can be
an Edit box with up/down increment buttons, defaulted to the
computed value, and containing degree change values (+#.degree. and
-#.degree.) under the second sub-column of the fourth column. Any
change to the value of this edit box system can: Change the values
of the edit boxes in the fourth column, second sub-column. Change
the "Additional Lordosis" value that is presented on the Surgery
Summary object, and vice versa. [0602] There can be Save button,
which system can save the changes made since the modal window has
been active, then close the window and return control to the
referring page [0603] There can be Cancel button, which system can
undo all of edits made since the modal window was popped up, then
close the window and return control to the referring page [0604]
Lordosis Distribution Calculations (Roussouly) (B2) [0605] There
can be a title "Calculations: Allocating additional lordosis across
levels". [0606] There can be instructions: "The total additional
lordosis for each of the upper and lower arcs, as well as the
additional segmental lordosis by level, can be directly adjusted."
[0607] There can be a matrix of data and objects: [0608] There can
be five rows, one for each level "L1/L2" through "L5/S1" [0609]
There can be five columns [0610] A first column with header label
"Level Selected for Fusion?", and a column of checkboxes that are
linked with the check boxes on the Surgery Summary Object (from the
Main Screen) and also in the tabs on the left side of the Main
Page. [0611] A second column with header label "DISTRIBUTION (from
Config)" plus a column of percent values (#%). Around the column of
data is a box with the label ".SIGMA.=100%" (note curvy equal sign)
[0612] A third, fourth, and fifth columns, which all get split
horizontally based on the location of the APEX of the lumbar curve
(See Calculations Features section for more detail about the Apex
calculation). [0613] A Third column: header label "A. DISTRIBUTION
(Adjusted)" a column of percent values (#%), excluding values from
rows that are not selected for fusion. Around each group of values
(above and below the horizontal split), there is a box with the
label ".SIGMA.=100%" (note normal equal sign) Underneath the column
is another label "The distribution function is adjusted so that the
sum of levels selected for fusion within each of the upper and
lower arcs is 100%." [0614] A Fourth column: header label "B.
ADDITIONAL LORDOSIS (input by user)" In the vertical center of each
section (above and below the horizontal split), an edit box with
up/down increment button. In the upper area, the label above the
edit box is "Upper Arc". In the lower area, the label above the
edit box is "Lower Arc". Any changes to the value in either of the
edit boxes in this column system can: change the value in the
corresponding edit boxes in the fifth column (second sub-column).
change the value of the corresponding edit box (either Upper Arc or
Lower Arc) on the Surgery Summary Object. [0615] A Fifth column:
header label "ADDITIONAL SEGMENTAL LORDOSIS (calc, B*C)" plus two
sub-columns, with each sub-column only containing data for those
levels that are selected for fusion: the first with sub-column
header label "Computed value" and a column of degree change values
(+#.degree. and -#.degree.) the second with sub-column header label
"User-Edited Value" a column of Edit boxes with up/down increment
buttons, defaulted to the computed value, and containing degree
change values (+#.degree. and -#.degree.). Changing the value in
any of the edit boxes in this column system can change the value in
the corresponding edit box(es) in the fourth column. [0616] There
can be Save button, which system can save the changes made since
the modal window has been active, then close the window and return
control to the referring page [0617] There can be Cancel button,
which system can undo all of edits made since the modal window was
popped up, then close the window and return control to the
referring page [0618] Edit Correction for Anticipated Subsidence
(C1) [0619] There can be a title "Edit Correction for Anticipated
Subsidence". [0620] There can be instructions: "The correction for
anticipated subsidence is a geometric calculation of the
anticipated lordosis loss that would occur given a specific amount
of millimeter lordosis and assumed implant length*. Change either
of these two parameters to alter the angle of require correction to
offset this subsidence, or vice versa." [0621] There can be a
matrix of data and objects: [0622] There can be five rows, one for
each level "L1/L2" through "L5/S1" [0623] There can be six columns:
[0624] A first column with header label "Level Selected for
Fusion?", and a column of checkboxes that are linked with the check
boxes on the Surgery Summary Object (from the Main Screen) and also
in the tabs on the left side of the Main Page. [0625] A second
column with header label "A. LENGTH OF SUPERIOR EDGE OF INFERIOR
VERTEBRAL BODY (from vertebral motion analysis)" plus a column of
millimeter values (#.#mm), excluding values from rows that are not
selected for fusion. [0626] A third column: [0627] header label "B.
ASSUMED LENGTH OF IMPLANT" [0628] plus two sub-columns, with each
sub-column only containing data for those levels that are selected
for fusion: the first with sub-column header label "From User
Config" and a column of millimeter values (#mm) the second with
sub-column header label "User-Edited Value" a column of Edit boxes
with up/down increment buttons, defaulted to the value from User
Config, and containing millimeter values (#mm). [0629] A fourth
column with header label "C. OFFSET (from vertebral motion
analysis)" plus a column of millimeter values (#.#mm), excluding
values from rows that are not selected for fusion. [0630] A fifth
column: [0631] header label "D. MAXIMUM ANTICIPATED ANTERIOR
SUBSIDENCE*" [0632] plus two sub-columns, with each sub-column only
containing data for those levels that are selected for fusion: the
first with sub-column header label "computed value" and a column of
millimeter values (#.#mm) the second with sub-column header label
"User-Edited Value" a column of Edit boxes with up/down increment
buttons, defaulted to the value from User Config, and containing
millimeter values (#.#mm). [0633] A sixth column [0634] with header
label "E. CORRECTION FOR ANTICIPATED SUBSIDENCE**" [0635] plus two
sub-columns, with each sub-column only containing data for those
levels that are selected for fusion: the first sub-column header
label "computed value" contains a column of degree change values
(+#.degree. and -#.degree.) the second sub-column header label
"User-Edited value" Edit boxes with up/down increment buttons,
containing degree change values (+#.degree. and -#.degree.),
defaulted to the computed value. [0636] Underneath the sixth column
are two values, one for each sub-column, which is the sum of the
sub-column, in degree change values (+#.degree. and -#.degree.),
and with the label "Sum=" to the left. [0637] There can be a label
on the bottom of the frame for notes: [0638] "* This estimate of
potential lordosis loss due to subsidence is a geometric
calculation based on the individual vertebral body dimensions of
each patient. This calculation uses an assumed "Maximum Anticipated
Anterior Subsidence" which represents the upper end of expected
subsidence. Consider adjusting upward from the default value when
patient has poor bone quality or when interbody device placement is
posterior. Consider adjusting downward from the default if the
level receives anterior fixation or when interbody device placement
is anterior. [0639] * Formula for E: .theta.=ArcTangent (Length/D);
Length=A/2+B/2-C" [0640] There can be Save button, which system can
save the changes made since the modal window has been active, then
close the window and return control to the referring page [0641]
There can be Cancel button, which system can undo all of edits made
since the modal window was popped up, then close the window and
return control to the referring page [0642] Calibrate (D) [0643]
There can be the title "Collect Grid Calibration Image: [0644]
There can be instructions: "The C-arm can be calibrated. Please
capture an image of the grid. For more information about how to
properly capture the grid image, please press help. [0645] Below is
an image that is coming from the fluoroscope. Please capture a grid
image on the fluoroscope, and when a grid image appears below press
"Accept Image" to continue." [0646] There can be a help button that
pulls up a help screen [0647] There can be a space for the fluoro
image feed that can be the native size of the image. (optimized for
1 k.times.1 k pixels, but able to accept up to 2 k.times.1.5 k)
[0648] There can be an "Accept Image" button, that when pressed
system can: [0649] grab the current image, and save it to the
[CALIBRATE DATA] data structure [0650] derive a correction matrix
from the saved calibration image, and save this to the [CALIBRATE
DATA] data structure. [0651] Change the status variable [CALIBRATED
YET] to TRUE [0652] Close the window and return the user to the
referring page. [0653] In the case that the user came to the
Calibrate (D) modal window after having pressed "Grab Frame" then
"OK" on the Capture Screen, then the user system can return to the
Capture Screen, and resume the set of actions specified to occur
directly following the check that is done on the status variable
[CALIBRATE STATUS] that occurs after the user presses "Grab Frame".
[0654] There can be a "Cancel" button, that when pressed does one
of two things: [0655] If the user came to the Calibrate (D) modal
window after having pressed "Grab Frame" then "OK" on the Capture
Screen, then: [0656] a message pop-up will be displayed "Cancelling
the calibration will make it impossible to continue with the prior
video capture action, and the image that was captured will be lost.
Press "CANCEL & LOSE PRIOR CAPTURE" or "GO BACK TO FINISH
CALIBRATION"". [0657] If user selects "Cancel", then: (1) the
message pop-up and the Calibrate modal window can be closed, (2)
return active control to the Capture screen, which itself will have
a pop-up message open, which system can close, and (3) on the
Capture screen the live video feed system can resume in the Image
Section. [0658] If user selects "Go back", then the message window
system can close and active control system can revert back to the
Calibrate modal window. [0659] ELSE, close the window and return
the user to the referring page.
[0660] Configure Screens [0661] The Configure Screen system can
have visible and active a "Save" and a "Cancel Button". [0662] The
same upper frame and buttons from the upper right section of the
Main Screen (with the Exit and Load Patient button) system can be
active and visible on the Configure Screen. [0663] Upon pressing
"Save", a pop-up click-through agreement is served to the user:
[0664] The agreement system can present the text: [0665] "All of
the preceding user configurations represent my personal medical
judgment. The convenience features included in this software do not
represent a specific medical diagnosis and it is my responsibility
to determine their clinical significance, if any, based my
training, experience and relevant clinical circumstances. I further
understand and acknowledge that the vertebral motion analysis can
be based on automatically or semi-automatically generated data, and
that I can manually review all potentially clinically relevant
information before relying upon any data presented via the system
for clinical decision making. [0666] I understand that the Company
will be storing my user configuration data, and will treat this
information as confidential and secure it to the same extent it
secures protected patient health information. I have read and
understand the above." [0667] The user can be presented with
buttons "I Agree" or "Cancel" [0668] Pressing "Cancel" system can
revert active control back to the Config Screens. [0669] Pressing
"I Agree" system can: [0670] Update the data associated with the
surgeon user to note that the click-through agreement has been
executed (see the section "Functional Features: Data saving and
storage"). [0671] Close the pop-up [0672] Revert active control
back to the page the user was on prior to pressing the "Configure"
button. [0673] There can be four tabs on the Configure Screen
[0674] There can be a first tab labeled "OPTIONS" [0675] There can
be a section labeled "Default Image Viewing Options" [0676] There
can be a sub-section labeled "OVERLAYS". There can be a column of 5
items, each item comprised of a checkbox (all defaulted to on),
icon, and label, and said item labels being "Target Construct",
"Current Capture", "Reference View", "Mobility Range", "Gravity
(plumb)" [0677] There can be a sub-section labeled "DISPLAY
OPTIONS". [0678] There can be a checkbox labeled "Images"
(defaulted to on) [0679] Indented from the "Images" label, there
can be a set of three radio buttons labeled "Reference View",
"Target Construct", and "Current Capture". Default value is
"Current Capture" [0680] There can be a checkbox labeled "Labels"
(defaulted to on) [0681] There can be a sub-section labeled
"ORIENTATION". [0682] There can be a set of three radio buttons
labeled "Reference View", "Current Capture", "Native", and
"Gravity". Default value is "Gravity" [0683] Next to the "Gravity"
label, and visible when the "Gravity" radio button is selected, is
a drop box labeled "If unavailable, use", that allows the user to
select from a list of "Current Capture" and "Native", which comes
defaulted to "Native" [0684] There can be a sub-section labeled
"LINEAR MEASUREMENTS". [0685] There can be a set of three radio
buttons labeled "% Max. Range", "Millimeters", and "% Vertebral
Body Depth". Default value is "Millimeters" [0686] There can be a
sub-section labeled "DEFAULT REFERENCE VIEW". [0687] There can be
two sub-areas, connected by a selector object that allows the user
to select between the two sub-areas (defaulted to select the first
sub-area [0688] The first sub-area can be labeled "MIN/MAX VIEWS",
and can have two sets of radio buttons. The first set can have two
radio buttons labeled "Min." and "Max." (Defaulted to Max.). The
second set can have four radio buttons labeled "Lordosis",
"Reduction", "Anterior Disc Height", "Posterior Disc Height"
(defaulted to Lordosis). [0689] The second sub-area can be labeled
"SPECIFIC VIEWS", and can have two sets of radio buttons. The first
set can have five radio buttons labeled "Standing, NO device,
bending views", "Standing, WITH device, bending views",
"Side-lying, bending views", "Supine, neutral view" and "Prone,
neutral view" (defaulted to "Standing, NO device, bending views".).
The second set can have three radio buttons labeled "Neutral",
"Flexion", and "Extension" (defaulted to neutral). This second set
of three radio buttons can be ghosted/inactive if the first set of
radio buttons assumes either of the values "Supine, neutral view"
and "Prone, neutral view" [0690] There can be a sub-section labeled
"Default Comparison View (during Capture)". [0691] There can be two
sub-areas, connected by a selector object that allows the user to
select between the two sub-areas (defaulted to select the second
sub-area) [0692] The first sub-area can be labeled "MIN/MAX VIEWS",
and can have two sets of radio buttons. The first set can have two
radio buttons labeled "Min." and "Max." (Defaulted to Max.). The
second set can have four radio buttons labeled "Lordosis",
"Reduction", "Anterior Disc Height", and "Posterior Disc Height"
(defaulted to Reduction). [0693] The second sub-area can be labeled
"SPECIFIC VIEWS", and can have two sets of radio buttons. The first
set can have five radio buttons labeled "Standing, NO device,
bending views", "Standing, WITH device, bending views",
"Side-lying, bending views", "Supine, neutral view" and "Prone,
neutral view" (defaulted to "Supine, neutral view".). The second
set can have three radio buttons labeled "Neutral", "Flexion", and
"Extension" (defaulted to neutral). This second set of three radio
buttons can be ghosted/inactive if the first set of radio buttons
assumes either of the values "Supine, neutral view" and "Prone,
neutral view" [0694] There can be a checkbox labeled "Same as
Default Reference View" which, when selected, will copy the
selections in the Default Reference View into this section. [0695]
There can be a second tab labeled "TARGET CONSTRUCT" [0696] There
can be a section labeled "Assumptions for Determining Sagittal
Alignment Corrections", which can be split into two sub-sections
[0697] There can be a set of two radio buttons, each one located at
the top of each subsection, labeled "Rothenfluh, 2014" and
"Roussouly, 2005). [0698] Next to each radio button label, there is
an icon "i" which system can bring up an image labeled either
[ROTHENFLUH IMAGE] or [ROUSSOULY IMAGE]. [0699] Underneath the
"Rothenfluh, 2014" radio button: [0700] There can be an edit box
with up/down increment buttons, labeled "Target Post-Op PI-LL:",
value in degrees (#.degree.), defaulted to 10 degrees. [0701] There
can be a label "Default constructs include PI-LL correction (if
PI-LL is less than target)?" Underneath the label can be a set of
two radio buttons, labeled "Include Correction in Default" and
"Default does NOT include Correction" (defaulted to Corrected)
[0702] Underneath the "Roussouly, 2005" radio button, there can be
the label "Roussouly method involves manually inputting the target
angles for the upper and lower lumbar arcs." [0703] There can be a
section labeled "Assumptions for Distributing Segmental Lordosis.
Select a Lordosis Distribution Function. This is simply a set of
five percent values, which sum to approximately 100%. This
represents the segmental lordosis at each level as a % of total
lumbar lordosis." [0704] Underneath the label there can be a
5.times.4 matrix of data: [0705] A set of five columns header
labels "L1/L2" "L5/S1" [0706] A set of four radio buttons with
labels: "Panjabi, et. al. (1992)", "Stagnara, et. al. (1998)",
"Average", and "User-defined". The radio button labels serve as row
header labels. The default value is "Average" [0707] There can be
an "i" icon to the right of the "Average" label that system can
bring up an image labeled [DISTRIBUTION FUNCTIONS IMAGE]. [0708]
The first three rows can have the values displayed in FIG. 11:
[0709] The last row can be a set of user editable text boxes,
defaulted to null, which allows a user to input a value between 1
and 100. Editing any of these boxes changes the radio button to be
equal to "User-Defined". Whenever data is entered and then saved, a
normalized distribution function can be calculated and used
whenever the distribution function data is used by the software,
which can be normalized such that the sum of the five user-entered
values can be equal to 100%. [0710] There can be a section labeled
"Calculation Assumptions" [0711] There can be three edit boxes with
up/down increment buttons, each defaulted to 2 and capable of
assuming the values 1-4. [0712] The labels on these edit boxes can
be "Minimum number of non-excluded levels for the "Lordosis"
calculation", "Minimum number of non-excluded levels for the "Disc
Height" calculation", and "Minimum number of non-excluded levels
for the "Offset" calculation" [0713] There can be a third tab
labeled "SUBSIDENCE" [0714] There can be a section labeled
"Default", which can have: [0715] A checkbox labeled "Include
additional lordosis to offset potential subsidence-related lordosis
loss?*", defaulted to on. [0716] An edit box with up/down increment
buttons, displaying a value in millimeters (#.#mm), defaulted to
2.0 millimeters [0717] There can be a section labeled "MASS*
Adjustment Assumptions" [0718] A checkbox labeled "Adjust the MASS*
value when gravity and the level are close to parallel?", defaulted
to on. [0719] An label, edit box with up/down increment buttons,
second label, a second edit box with up/down increment buttons, and
a third label [0720] First edit box: label to the left of the edit
box "Reduce MAAS* by", value is millimeters (#.#mm), defaulted to
-1.0 mm. [0721] Second edit box: label "when gravity and the level
are within", value is in degrees (##.degree.), defaulted to 30
degrees [0722] The third label: "degrees of being parallel (in
standing, NO device, neutral view)." [0723] There can be a section
labeled "Assumed Implant Dimensions (for the geometric
calculations)" [0724] There can be two scales of 10 to 50
millimeters, on which users can specify whole number points (i.e.
the sliders "snap" to the whole numbers). [0725] The first scale
can be labeled "VERTEBRAL BODY SIZE DEFINITIONS (anterior-posterior
depth in millimeters)" [0726] This scale can have two points
defined by the user, corresponding to three contiguous regions
labeled "Small", "Medium" and "large". [0727] The default values
can be: Small-Medium: 30 mm; Medium-Large: 35 mm. [0728] The second
scale can be labeled "ASSUMED RANGE OF INTERBODY DEVICE SIZE
(anterior-posterior depth in millimeters)" [0729] This scale can
have six points defined by the user, corresponding to three ranges
labeled "Small", "Medium" and "large", with each range comprising
two points (start, end), which may or may not overlap or be
contiguous. [0730] The default values are:
TABLE-US-00001 [0730] Range of Interbody Device A/P Depth Start End
14 mm 22 mm 18 mm 26 mm 22 mm 30 mm
[0731] There can be the footnote: "*This estimate of potential
lordosis loss due to subsidence is a geometric calculation based on
the individual vertebral body dimensions of each patient. This
calculation uses an assumed "Maximum Anticipated Anterior
Subsidence" which represents the upper end of expected subsidence.
Consider adjusting upward from the default value when patient has
poor bone quality or when interbody device placement is posterior.
Consider adjusting downward from the default if the level receives
anterior fixation or when interbody device placement is anterior."
[0732] There can be a fourth tab labeled "ALERTS" [0733] There can
be a section labeled "Surgical Considerations", which can have a
3.times.4 matrix of data and objects: [0734] The first row can have
the following three elements: an "Alert text" label, a second item
comprised of a yellow triangle alert icon plus an edit box
defaulted to the value "Possible", and a third element comprised of
a red triangle alert icon plus an edit box defaulted to the value
"Likely" [0735] Rows 2-4 in the first column system can contain
edit boxes defaulted to the values "Smith Peterson osteotomy",
"Pedicle subtraction osteotomy (PSO)", and "ALL release procedure"
[0736] Cell (2,2) can have "Target PDH<X % PDH @ standing
neutral", where X is an edit box (#%) defaulted to 100%. [0737]
Cell (2,3) can have "Target PDH<X % minimum PDH across all
images", where X is an edit box (#%) defaulted to 100%. [0738] Cell
(2,4) can have "Target ADH>X % maximum ADH across all images",
where X is an edit box (#%) defaulted to 125%. [0739] Cell (3,2)
can have "Target PDH<X % minimum PDH across all images", where X
is an edit box (#%) defaulted to 100%. [0740] Cell (3,3) can have
"Target PDH is less than X", where X is an edit box (#mm) defaulted
to 0 mm [0741] Cell (3,4) can have "Target ADH>X % maximum ADH
across all images", where X is an edit box (#%) defaulted to 150%.
[0742] There can be a section labeled "Sagittal Alignment Alert
Thresholds", which can have a 2.times.2 matrix of data and objects:
[0743] The 2 row labels can be "Rothenfluh" and "Roussouly" [0744]
There can be no column header labels. [0745] Cell (1,1) can have a
yellow triangle alert icon, and an edit box with up/down increment
buttons, label "PI-LL.gtoreq.", value is in degrees (##.degree.),
defaulted to 8 degrees [0746] Cell (2,1) can have a red triangle
alert icon, and an edit box with up/down increment buttons, label
"PI-LL.gtoreq.", value is in degrees (##.degree.), defaulted to 10
degrees [0747] Cell (2,1) can have two sub-sections, connected by a
drop-down box that can select from the list of "AND" and "OR"
(defaulted to "OR") [0748] The first sub-section can be a set of
four checkboxes, with labels "Type 1", "Type 2", "Type 3", and
"Type 4". Defaulted to Type 1 and Type 2 being on. [0749] The
second sub-sections system can consist of an edit box with up/down
increment buttons with a label on top, which is on top of a second
edit box with up/down increment buttons with a label on top, which
is on top of a third label: First edit box: label "Pelvic Tilt
between", value is degree (#.degree.), defaulted to -25 degrees.
Second edit box: label "and", value is degree (#.degree.),
defaulted to 30 degrees. The third label: "inclusive" [0750] Cell
(2,2) can have two sub-sections, connected by a drop-down box that
can select from the list of "AND" and "OR" (defaulted to "AND")
[0751] The first sub-section can be a set of four checkboxes, with
labels "Type 1", "Type 2", "Type 3", and "Type 4". Defaulted to
Type 1 and Type 2 being on. [0752] The second sub-sections system
can consist of an edit box with up/down increment buttons with a
label on top, value is degree (#.degree.), defaulted to 30
degrees.
[0753] Status Variable Features [0754] There can be a Boolean
status variable [CALIBRATED YET] [0755] The default value is FALSE
[0756] The value changes to TRUE the user pressing the "Accept
Image" button on the Calibrate (D) modal window and the function to
derive the correction matrix executes successfully. [0757] There
can be a status variable [CAPTURE STATUS] that is associated with
each level. [0758] The possible values can be: "No Capture Yet" or
"Current Capture with no prior captures" or "Current Capture with
Prior captures" [0759] The default value can be "No Capture Yet"
[0760] The value of [CAPTURE STATUS] can be determined by the set
of instances of [CAPTURE DATA]. For all instances, count the number
of instances for which [MARKUP STATUS]=Step 5 and [MARKUP SAVE
STATUS]="Saved": [0761] "No Capture Yet" whenever the count is zero
[0762] "Current Capture with no prior captures" whenever the count
is 1 [0763] "Current Capture with Prior captures" whenever the
count is 2 or greater. [0764] There can be a status Variable
[MARKUP STATUS], [MARKUP LEVEL], and [MARKUP SAVE STATUS]
associated with Capture Image [0765] These variables can be able to
assume the values: [0766] [MARKUP STATUS]: Step 0 to Step 5 [0767]
[MARKUP LEVEL]: "Unspecified", "L1/L2" . . . "L5/S1" [0768] [MARKUP
SAVE STATUS]: "Saved" or "Unsaved" [0769] These variables system
can get initiated each time the user presses "Grab Frame" on the
Capture Screen, (which triggers the creation a new instance of the
[CAPTURE IMAGE] dataset). [0770] [MARKUP STATUS] is set to Step 0
[0771] [MARKUP LEVEL] is set according to which radio button is
selected. If no radio button is selected (i.e. [ACTIVE
LEVEL]=Null), then this is defaulted to the value "Unspecified"
[0772] [MARKUP SAVE STATUS] is set to "Unsaved" [0773] The [MARKUP
LEVEL] Variable can be changed by the user at any time by
interacting with the radio buttons at the top of the left pane of
the Capture Screen. [0774] The [MARKUP LEVEL], [MARKUP LEVEL], and
[MARKUP SAVE STATUS] variable can also be changed according to the
workflow described in the Capture Screen section of this document.
[0775] There can be the status variable [ADDITIONAL LORDOSIS FOR SA
CORRECTION STATUS] that is associated with each user session.
[0776] The possible values can be: null, "Not Confirmed" or
"Confirmed" [0777] The default value can be: [0778] If user config
specifies Rothenfluh AND [0779] if user config specifies that PI-LL
corrections ARE to be included in the default, then the default
value can be "Not Confirmed". [0780] Else, then the default value
can be null [0781] If user config specified Roussouly, then the
default value can be null [0782] The value of [ADDITIONAL LORDOSIS
FOR SA CORRECTION STATUS] can be changed by any one of the two
actions below, and once it changes its value from the default it
typically does not revert to any other value [0783] On the Surgery
Summary Object: (1) clicking on the "OK" on the button next to the
Additional Lordosis edit box, (2) editing a value into this edit
box, or (3) using the plus or minus increment buttons. [0784] On
the Lordosis Distribution Calculations, Rothenfluh (B1) modal
window, pressing the "Save Button" (regardless of whether or not
any values had been edited while the modal window had been active)
[0785] There can be a Boolean status variable [CHECKBOX COLUMNS
ACTIVE] associated with each of the columns of checkboxes for
excluding Disc Height and Offset. [0786] The default value can be
TRUE [0787] The value of [CHECKBOX COLUMNS ACTIVE] changes to FALSE
whenever, on the Edit Midline Disc Height (A1) or Edit Offset (A2)
modal window, any of the values in the rightmost column differ from
the computed average (after exclusions) [0788] There can be a
status Variable [ACTIVE LEVEL] associated with each patient use
sessions [0789] The possible values can be: null, "L1/L2" . . .
"L5/51" [0790] The default value can be null [0791] The value of
[ACTIVE LEVEL] can be changed by any one of the three actions:
[0792] The user clicking one of the five tabs ("L1/L2" . . .
"L5/51") from within the set of seven tabs that is present on the
upper portion of the left pane of both the Main Screen and capture
Screen. When this occurs, ACTIVE LEVEL is set to the level that the
user clicks. [0793] The user selecting a level in the upper portion
of the left pane of the Capture Screen. [0794] The user completing
a four point markup of a level's disc space while on the Capture
Screen. When this occurs, ACTIVE LEVEL is set to the level that
underwent the 4 point markup. [0795] There can be status Variables
[REFERENCE VIEW] and [COMPARE PRIOR MARKUP VIEW] associated with
each patient use sessions [0796] These Variables comes defaulted to
the view specified in the User Config pages. [0797] These variables
are changeable wherever there is: (1) a drop down labeled
"reference View" for [REFERENCE VIEW], or (2) a drop down labeled
"Compare to Prior Spine Markup" for [COMPARE PRIOR MARKUP VIEW]
[0798] Each of the [REFERENCE VIEW] items below may or may not have
gravity data, however the Standing NO Device, neutral view can have
gravity data [0799] These variables can assume the following values
(also note the values below are the [VIEW TEXT] text string which
appears in labels in some other sections of the software) [0800]
Min/Max Views (there is an image for this) [0801] Max Lordosis
[0802] Max Reduction [0803] Max ADH [0804] Max PDH [0805] Min
Lordosis [0806] Min Reduction [0807] Min ADH [0808] Min PDH [0809]
Specific Views (These only display if they exist): [0810] Standing
NO Device Neutral [0811] Standing NO Device Flexion [0812] Standing
NO Device Extension [0813] Supine [0814] Prone [0815] Standing WITH
Device Neutral [0816] Standing WITH Device Flexion [0817] Standing
WITH Device Extension [0818] Lying WITH Device Neutral [0819] Lying
WITH Device Flexion [0820] Lying WITH Device Extension [0821] Prior
Capture (this section of the list is only active if [CAPTURE
STATUS] is set to "Current Capture with Prior captures" [0822]
There can be a list of all previous prior, with each prior capture
labeled as "X capture(s) ago ([time/date stamp]), ["markup
complete" or "markup not complete"]". If [CAPTURE STATUS] "No
Capture Yet", then the text above system can include the element
"markup not complete", else this can be "markup complete". [0823]
Each element on the list of Previous captures can be visible, if
the prior captures has [MARKUP STATUS] of Step 5 and [MARKUP SAVE
STATUS] of "Saved"
[0824] Data Structure Features: [0825] An array of computed values
based on default values, which system can get updated upon any
change to the user config variables and change to the levels
selected for fusion, but otherwise do not change throughout a
testing session [0826] Additional Sagittal Alignment correction, by
level (segmental) and across all level selected for fusion s [0827]
Correction for Anticipated Subsidence, by level and across all
levels selected for fusion [0828] Maximum Anticipated Anterior
Subsidence (MAAS), by level. [0829] Target Construct default
values, by level and across all levels selected for fusion [0830]
Total Segmental lordosis for all levels selected for fusion (adding
all of the above three items) [0831] An array of current values, as
edited by the user: [0832] via direct edit on an edit box [0833]
Sagittal Alignment correction, by level and across all level
selected for fusion s [0834] Correction for Anticipated Subsidence,
Maximum Anticipated Anterior Subsidence, Assumed Implant Length, by
level [0835] Total Segmental lordosis (adding all of the above
three items) [0836] Midline Disc Height and Offset. [0837] via
grab/drag or drag/rotate actions in the Disc Space Diagram. [0838]
Target Construct values (lordosis, Midline disc height, offset)
[0839] via selections/deselections from checkbox arrays [0840]
Levels selected for fusion [0841] Levels selected for exclusions
for lordosis, disc height, and offset [0842] Via an array of
dropdowns: [0843] Lordosis data source by level [0844] An array of
current calculated values, based on the array of current user-set
values, which system can include all of the variables specified to
be calculated in the "Calculation Features" section. Note these are
the values that get calculated based off the combination of default
values and current values (as edited by the user). [0845] There can
be a data structure [CALIBRATE DATA] which can be created/updated
upon a calibrate action (see Calibrate modal window), and which
system can store an instance of an image and a correction matrix
associated with the calibration action. [0846] There can be a data
structure [CAPTURE DATA], which can be created upon a video capture
action that occurs in the Capture Screen [0847] Current Capture
Image--This system can contain the image file that is created with
the video capture action [0848] [MARKUP STATUS]--This can be a
status variable (See Status Variable Features Section). This can
assume the values Step 0 through Step 5 [0849] [MARKUP LEVEL]--This
can be a status variable (See Status Variable Features Section).
This can assume the values "Unspecified", "L1/L2" "L5/51". [0850]
[MARKUP POINTS]--This is 4 coordinate (x,y) sets representing pixel
locations relative to the Current Capture Image. The 4 coordinate
sets are named: 1_INF_VERT_POST_SUP_CORNER,
2_INF_VERT_ANT_SUP_CORNER, 3_SUP_VERT_POST_INF_CORNER,
4_SUP_VERT_ANT_INF_CORNER [0851] [MARKUP SAVE STATUS]--This can be
a status variable (See Status Variable Features Section). This can
assume the values "Saved" and "Unsaved".
[0852] Alerts Features: [0853] Alerts can have the following
attributes: Severity (null, yellow, red), Short text (2 or 3 upper
case letters), and a long text (a constructed text string). [0854]
There can be two types of alerts (Surgical Considerations and
Sagittal Alignment alerts), each having its own set of icon/short
text items as well as long text items [0855] Surgical consideration
alerts (PSO, SP, ALL) [0856] These alerts can be structured as a
posterior alert and an anterior alert, each of which can be
activated or deactivated independently. [0857] The icon/short text
version: [0858] Anterior alerts can be of either one or two
configurations: Triangle/Triangle (".DELTA.XXX/.DELTA.XXX"), in the
case that an SP and a PSO alert we both activated. [0859] Triangle
(".DELTA.XXX"), in the case that one or the other was activated
[0860] Posterior alerts system can only be of the Triangle
(".DELTA.XXX") configuration, and can be of the type ALL. [0861]
The long text system can comprise the string: [STRING1] &" . .
. "& [STRING2]. [0862] STRING1: Defined by User Config, as the
combination of the [DESC COLOR] & [DESC PSO, SP, ALL]. For
example "Likely Smith-Peterson osteotomy" or "Potential ALL release
procedure" [0863] STRING2: Threshold text: Defined by User Config.
For example: Yellow/PSO: "Target PDH<100% minimum PDH across all
images". Red/SP: Target ADH>150% maximum ADH across all images"
[0864] Sagittal Alignment alerts (SA). [0865] The icon/short text
version of the Sagittal Alignment alerts is "A SA". [0866] The long
text can be structured differently depending on whether the user
configuration specified the "Rothenfluh" or the "Roussouly" method
for determining Sagittal Alignment corrections. [0867] For users
configured to "Rothenfluh": Long Text: system can comprise two
strings, joined together: [STRING1] & "." & [STRING2].
STRING1: "Potential Sagittal Alignment issues:" STRING2: Select
which applies: "PI-LL is between X and Y" [this potentially applies
to the yellow condition], "PI-LL is above Y." [this potentially
applies to the red condition]. NOTE: X and Y are the User Config
threshold values. [0868] For users configured to "Roussouly", there
system can comprise two strings, joined together: [STRING1] &
"." & [STRING2]. STRING1: "Potential Sagittal Alignment
issues:" [0869] STRING2: Include all that apply: "Type X
Lordosis.", "Pelvic Tilt between X and Y" [this potentially applies
to the yellow condition], "Pelvic Tilt is above Y." [this
potentially applies to the red condition]. NOTE: X and Y are the
User Config threshold values. [0870] There can be the following
alerting functionality on the following objects: [0871] Left Pane:
Sagittal Alignment Diagram. [0872] For either Rothenfluh or
Roussouly type Sagittal Alignment alerts, the alert icons Plus the
short text can be visible when activated (see details in the
Sagittal Alignment Diagram section for more info on placement).
[0873] When one of the alert icons and short text is visible, when
the user moves the mouse over the icon/text, a text box pops up
with the Long Text for the alert. [0874] Left Pane: Disc Space View
Diagram: [0875] The following alert items can be visible when
activated: [0876] For the Rothenfluh type Sagittal Alignment
alerts, the alert icon Plus the short text can be visible when
activated (this appears on the rightmost column of the Dimensions
Table). [0877] For Surgical consideration alerts, the alert icons
plus short text can be visible when activated (this appears on the
Distance From/To Diagram). See Disc Space View Diagram section for
more details on placement. [0878] When one of the alert icons and
short text is visible, when the user moves the mouse over the
icon/text, a text box pops up with the Long Text for the alert.
[0879] Right Pane: Surgery Summary: [0880] The following alert
items can be visible when activated: [0881] For Rothenfluh &
Roussouly type Sagittal Alignment alerts, the alert icon Plus the
short text can be visible when activated (this appears in the
middle section, see Surgery Summary section for more details on
placement) [0882] For Surgical consideration alerts, the alert
icons plus short text can be visible when activated (this appears
column next to the column of checkboxes with the column header
label "Fusion at this level?") [0883] When one of the alert icons
and short text is visible, when the user moves the mouse over the
icon/text, a text box pops up with the Long Text for the alert.
[0884] Right Pane: Level Summary: Surgical Considerations [0885] In
the upper sub panel for Surgical Considerations, each alert icon,
short text, and long text are presented (Up to three sets possible,
no mouse-over popups, format ".DELTA.XXX: [LONG TEXT STRING]". Note
that the icon/short text is different here than described above for
the anterior alerts. In that section, a single combined icon/short
text is created in the case that both SP and PSO alert is
triggered. In this section, each gets its own row, and there is no
single combined icon displayed in the case that both SP and PSO
alerts are triggered).
[0886] Calculation Features: [0887] There is a set of sequential
calculations steps which provide updates to the Sagittal Alignment
Diagram, Disc Space Diagram, Surgery Summary Object, Level Summary
Object: [0888] can be triggered by a range of actions, each action
triggering a the calculations to start at a potentially different
point in the calculation sequence: [0889] Actions that lead to the
need to do the first, second, and third steps: [0890] Main Page:
Surgery Summary object--Direct editing the [Additional Lordosis for
Sagittal Alignment Corrections], [Upper Arc Additional Lordosis],
[Lower Arc Additional Lordosis), changing the level excluded from
lordosis calculations [0891] Main Page: Level Summary
object--Directly editing [Total Segmental Lordosis], [Additional
Segmental Lordosis for Sagittal Alignment Correction], [Segmental
Correction for Anticipated Subsidence], or Maximum Anticipated
Anterior Subsidence] [0892] Main Page: Disc Space
Diagram--Grab/rotate target construct line. [0893] Edit Lordosis
(A3) modal window--Changing the levels excluded from lordosis
calculations [0894] Lordosis Distribution Calculations modal
windows--Editing [Additional Segmental Lordosis for Sagittal
Alignment Corrections] (there may be up to five values, and the
calculation is triggered by changes to any one of the up to five
values), [Additional Lordosis for Sagittal Alignment Corrections],
[Upper Arc Additional Lordosis], [Lower Arc Additional Lordosis],
[0895] Edit Correction for Anticipated Subsidence modal window:
Directly editing [Assumed Implant Length], [Segmental Correction
for Anticipated Subsidence], or [Maximum Anticipated Anterior
Subsidence] [0896] Actions that lead to a recalculation of the
second and third steps include: [0897] Main Page: Surgery Summary
object--changing the levels excluded from either disc height and
offset calculations. [0898] Main Page: Disc Space
Diagram--Grab/Drag of the Target Construct line [0899] Edit Midline
Disc Height (A1 modal window: editing the Average Disc Height.
(there may be up to five values, and the calc is triggered by
changes to any one of the up to five values) [0900] Edit Offset
(A2) modal window: editing the Average offset. (there may be up to
five values, and the calculation is triggered by changes to any one
of the up to five values) [0901] Actions that lead to the
recalculation of the third step: [0902] Main Page: Surgery Summary
object--changing the Lordosis Data source at a level. [0903] First
Step: Calculate Segmental Lordosis At each Level selected for
fusion. [0904] The sum equation for this calculation is [Total
Segmental Lordosis]=[Target Segmental Lordosis]+[Additional
Segmental Lordosis for Sagittal Alignment Correction]+[Segmental
Correction for Anticipated Subsidence]. [0905] This calculation can
be performed upon any of the four user actions [0906] User directly
inputs [Total Segmental Lordosis] [0907] This can be done via
grab/rotate of the Disc Space Diagram, or by Direct Editing on the
Level Summary Object. [0908] As the [Total Segmental Lordosis]
value is changed by the user, the [Additional Segmental Lordosis
for Sagittal Alignment Correction] is changed to keep the sum
equation in balance. [0909] User changes [Target Segmental
Lordosis]: [0910] This can be done via changing the set of levels
excluded from lordosis calculations via interacting with the
"exclude" checkboxes on the Surgery Summary page or the Edit
Lordosis window [0911] As this value is changed, the [Total
Segmental Lordosis] is changed to keep the sum equation in balance.
[0912] User changes the [Additional Segmental Lordosis for Sagittal
Alignment Correction] [0913] This can be done via: Directly editing
the [Additional Segmental Lordosis for Sagittal Alignment
Correction] on the Level Summary Object and the Lordosis
Distribution Calculations modal windows In the case of ROTHENFLUH:
Directly editing the [Additional Total Lordosis for Sagittal
Alignment Correction] in the Surgery Summary Object and the
Lordosis Distribution Calculations modal window. ROUSSOULY:
Directly editing the either the [Upper Arc Additional Lordosis] or
the [Lower Arc Additional Lordosis] for Sagittal Alignment
Correction in the Surgery Summary Object and the Lordosis
Distribution Calculations modal window. In either case, as this
revised number is distributed across levels, the [Additional
Segmental Lordosis for Sagittal Alignment Correction] system can
change. Selecting or deselecting additional levels for fusion, on
the row of checkboxes on the tabs on the upper part of the left
pane, or on the column of checkboxes on the Surgery Summary Object
[0914] As the [Additional Segmental Lordosis for Sagittal Alignment
Correction] value is changed by the user, the [Total Segmental
Lordosis] is changed to keep the sum equation in balance. [0915]
User changes the [Segmental Correction for Anticipated Subsidence]
[0916] This can be done via: direct edits to the [Segmental
Correction for Anticipated Subsidence] via in the Level Summary
Object and the Edit Correction for Anticipated Subsidence modal
window Whenever [Segmental Correction for Anticipated Subsidence]
changes, the value for [Maximum Anticipated Anterior Subsidence]
changes as well, and the value for [Assumed Implant Length] is held
constant. Direct edits to the [Maximum Anticipated Anterior
Subsidence] number via in the Level Summary Object and the Edit
Correction for Anticipated Subsidence modal window Direct edits to
the [Assumed Implant Length] number via in the Edit Correction for
Anticipated Subsidence modal window [0917] [Segmental Correction
for Anticipated Subsidence], .theta., system can change whenever
the Maximum Anticipated Anterior Subsidence number (D) or the
Assumed Implant Length number (B) changes: .theta.=ArcTangent
[(A/2+B/2-C)/D]. Note: A=Length of superior edge of inferior
vertebral body (from vertebral motion analysis). C=Offset (from
vertebral motion analysis). [0918] As the [Segmental Correction for
Anticipated Subsidence] value is changed by the user, the [Total
Segmental Lordosis] is changed to keep the sum equation in balance.
[0919] As will be appreciated by those skilled in the art, that
there is one mechanism by which the for [Segmental Correction for
Anticipated Subsidence] is automatically or semi-automatically
updated by the system, via an automated or semi-automated
adjustment to the [Maximum Anticipated Anterior Subsidence] number,
which also trigger a recalculation according to this first step.
See the description of the automatic adjustment later in this
Calculation Features section, in the section titled "Computed
values for [Segmental Correction for Anticipated Subsidence]"
[0920] Second Step: Calculate Geometric Transform at each level
selected for fusion to Update the Disc Space Diagram and Distance
From/To Diagrams [0921] The calculation is: [0922] The input for
this calculation can be [0923] depth of the inferior vertebral
body's superior endplate the superior vertebral body's inferior
endplate [0924] Midline Disc Height [0925] Offset [0926] [Total
Segmental Lordosis] [0927] This calculation can be performed
according to the diagram of FIG. 12. [0928] The process steps of
the Calculation can be: [0929] Origin is posterior superior corner
of inferior vertebral body (point A). [0930] Horizontal origin is
defined by point B, which gets placed along the horizontal origin
at a distance from A equal to the depth of the inferior vertebral
body's superior endplate. [0931] Point C is placed on the midpoint
between A and B, moved upward to the midline disc height (avg. of
PDH and AHD). [0932] Place a line going through C that is parallel
to the [Total Segmental Lordosis]. [0933] Place a point D along
that line, such that the distance between A and D along the AB line
is equal to the offset [0934] Place point E along that line at a
distance from D equal to the depth of the superior vertebral body's
inferior endplate [0935] The Output of this geometric transform is
[0936] Coordinates of A, D, E, and B. A=0,0 [0937] ADH: Length of
the line dropped from D to the intersection of AB. [0938] PDH:
Length of line dropped from E to the intersection of AB. [0939] The
calculation is triggered by any of the following 3 actions: [0940]
Performance of the First Step above. [0941] User Changes the
Average Midline Disc Height, either by excluding level via
interacting with the "exclude" checkboxes on the Surgery Summary
page or the Edit Midline Disc Height modal window. [0942] Changing
the Average Offset, either by excluding level via interacting with
the "exclude" checkboxes on the Surgery Summary page or the Edit
Offset modal window. [0943] Third Step: Calculate Geometric
Transform across all levels to update the Sagittal Alignment
Diagram [0944] The calculation is: [0945] Stack Levels on top of
levels, using the appropriate geometric points based on the current
value of the Lordosis Data Source (from the Surgery Summary
Object), to produce a new set of coordinates for the vertebral
bodies and labels in the Sagittal Alignment Diagram. [0946]
Calculate: Lumbar Lordosis (LL), PI-LL, [Additional Lordosis for
Sagittal Alignment Corrections] default value, Lumbar Apex,
Roussouly Type. (Note: PT, SS, and PI typically does not change).
[0947] The calculation is triggered by any of the following 2
actions: [0948] Performance of the Second Step above [0949] Change
to Lordosis Data Source on the Surgery Summary Object [0950] There
are several calculation steps described, whose features are further
defined: [0951] Computed values for Target Lordosis at a Level (for
Rothenfluh and Roussouly) can be calculated according to the design
of the Edit Lordosis (A3) modal window. [0952] Computed values for
Additional Lordosis for Sagittal Alignment (Correction Rothenfluh),
can be: [0953] For the total (across all levels selected for
fusion), the computed value can be: [0954] for any patient wherein
the PI-LL is above the user defined threshold, the value can be
[PI-LL] Minus the target. [0955] For patients with PI-LL below the
user defined threshold, the value can be zero (no null). [0956] The
default value of the edit box for this value on the Surgery Summary
Object system can assume either: (1) the computed value above, if
the user config specifies that the default IS to include Sagittal
Alignment corrections, or (2) zero if the user config specifies
that the default is to NOT include sagittal alignment corrections.
[0957] For segmental Additional Lordosis for Sagittal Alignment
Correction, can be calculated according to the design of the
Lordosis Distribution Calculations, Rothenfluh (B1) modal window.
[0958] Computed values for Additional Lordosis for Sagittal
Alignment (Roussouly), system can: [0959] Default for the Upper Arc
and Lower Arc Additional Lordosis for Sagittal Alignment Correction
is zero [0960] For segmental Additional Lordosis for Sagittal
Alignment Correction, can be calculated according to the design of
the Lordosis Distribution Calculations, Roussouly (B2) modal
window. [0961] Computed values for [Segmental Correction for
Anticipated Subsidence]: [0962] Can be calculated according to the
design of the Edit Correction for Anticipated Subsidence (C1) modal
window. [0963] The [Maximum Anticipated Anterior Subsidence] value
can be adjusted automatically or semi-automatically by the software
based on the difference between the plumb line angle and the
average angle (relative to the plumb line) between the superior
edge of the inferior vertebral body and the inferior edge of the
superior vertebral body. Whenever this difference is less than the
value specified in user config, the [Maximum Anticipated Anterior
Subsidence] value is adjusted by an amount as specified in user
config, and then accordingly the [Segmental Correction for
Anticipated Subsidence] is adjusted as well. [0964] Lumbar Apex:
This value can be calculated according to the following formula
pseudo-code:
TABLE-US-00002 [0964] If MIN ( Abs (PEA.sub.L3), Abs (PEA.sub.L4),
Abs (PEA.sub.L5) ) = Abs (PEA.sub.L3) THEN LA = L3 ELSE If Abs
(PEA.sub.L4) < Abs (PEA.sub.L5), THEN LA = L4 ELSE LA = L5 SS =
Sacral Slope LA = Lumbar Apex PEA.sub.LX = Posterior edge angle
(vs. plumb) for vertebral body X
[0965] Roussouly Type: This value can be calculated according to
the following formula pseudo-code:
TABLE-US-00003 [0965] Roussouly typing is done based on two
parameters, which can agree to get a result: If SS < 35 AND LA =
L5: Type text = "Type 1" If SS < 35 AND LA = L4: Type text =
"Type 2" If (SS .gtoreq. 35 AND .ltoreq. 45) AND LA = L4: Type text
= "Type 3" If SS > 45, AND LA = L3 or higher: Type text = "Type
4" No result scenarios: If SS < 35 AND LA=L3: Type text =
"ERROR: Type 1-2 based on Sacral Slope, but apex is not L4-L5" If
(SS .gtoreq. 35 AND .ltoreq. 45) AND (LA = L5 OR L3): Type text =
"ERROR: Type 3 based on Sacral Slope, but apex is at [L5/L3] not
L4" If SS > 45 AND (LA = L4 or L5): Type text = "ERROR: Type 4
based on Sacral Slope, but apex is at [L4/L5] not L3" SS = Sacral
Slope LA = Lumbar Apex
[0966] Input File Features [0967] The filenames that the system
uses as input can be of the filename type: "XX_MMDDYYYY", where
XX=First initial and last initial, and MMDDYYYY is the patient's
date of birth. [0968] The following data can be available from the
input fileset: [0969] For Each study, [0970] Atypical anatomy (L6,
S2, no L5, etc.)? Boolean TRUE/FALSE [NOTE: Currently, this is
FALSE. In other configurations, a variable might be used, which
results in a value other than FALSE]. [0971] PI, LL, SS, PT: Four
different numbers. Non-integer (double). Degree units. [0972]
Patient identifier: [0973] Patient name: Two Strings (first, last).
If there is a middle initial, it will be contained with the first
name string. All strings are of unspecified length (i.e. length not
controlled). [0974] Date of birth: String of "YYYYMMDD" [0975] Sex:
String "M" or "F" [0976] Template confirmation occurred? Boolean
TRUE/FALSE [NOTE: Currently, this will is FALSE. In other
configurations, a variable might be used, which results in a value
other than FALSE]. [0977] For Each level: From standing neutral,
get: [0978] In both % VBD and mm: [0979] ADH, PDH, midline and
Offset: Non-integer (double). For % VBD, 1%=1 (not 0.01). [0980]
Two instances of each data point (one in % VBD, one in mm) [0981]
lordosis and max lordosis: Non-integer (double). Degree units.
[0982] Max/min mobility (ADH, PDH, Offset) at each level. This is a
set of min and max values for each of ADH, PDH, and Offset.
Non-integer (double). Millimeter units. In the case of ADH and PDH,
this is the millimeters to the min and max displacement relative to
the anterior superior corner and posterior superior corner
(respectively) of the inferior vertebral body of a level. [0983]
For Each vertebral body: From standing neutral, get: [0984] Angle
measurements (vs. plumb): Angle of anterior edge, posterior edge,
superior endplate and posterior endplates. Non-integer (double).
Degree units. [0985] Coordinates for each of the four corners of
each vertebral body. Non-integer (double) pair of (x,y)
coordinates, where (1,1) is the upper left most point. Units will
be in pixels or millimeters. Ideally the system should be able to
handle both. These coordinates are used in the Sagittal balance
diagram. [0986] Length of each of the four edges. Non-integer
(double). Millimeter units. [0987] Labels of each vertebral body,
and the location of where the labels system can go [0988] Pdfs of
report package (without images) [0989] Image arrays. These are
further specified below. The image arrays contain the following
data elements: [0990] A set of 29 to 153 jpeg image files (without
templates) [0991] Two arrays of pointers to files contained in this
image set: [0992] 5.times.11 array for Specified Views [0993]
5.times.8 array for Min/Max views [0994] A 5.times.18 array, each
element containing: [0995] two sets of 4 (x,y) points (8 sets in
total), one each for the superior and inferior vertebral body. Each
of these 8 sets of (x,y) points will be from an origin at the upper
left hand corner of the associated image (the upper left point is
(1,1)). Units will be in pixels or millimeters. Ideally the system
should be able to handle both. [0996] Labels of each vertebral
body, and the location of where the labels should be placed on the
image [0997] Further specification of image arrays [0998] Specific
views: [0999] This system can include up to all 11 views (standing
uncontrolled flex/ext/neutral, standing controlled flex/ex/neutral,
lying controlled flex/ex/neutral, supine, prone). If views are
missing they can be absent from the image array. [1000] Each view
will have a pelvic view and an inferior view, and some might
additionally have superior view Therefore this set of images is 22
min and 33 max. [1001] A 5.times.11 array of pointers needs to be
created that lists all 5 Levels (L1/L2 through L5/S1) and all 11
views, such that for each cell there is a pointer to the
appropriate image file that contains that vertebral body [1002]
Min/Max Views: [1003] In preparing the data, for each of the 5
Levels (L1/L2 through L5/S1), the following specific images need to
be pulled and saved to the data structure: [1004] Min lordosis, max
lordosis (min lordosis is the largest absolute inter-vertebral
angle, and max lordosis is the minimum absolute inter-vertebral
angle) [1005] Min ADH, Offset, and PDH. Max ADH, Offset and PDH.
[1006] This is a total of: [5 levels].times.[4 min+4 max=8]=40
views. [1007] These views, plus any of the 11 that are not already
included in the 40 views above, are saved to the data file. This
means that a min of 29 (if all 11 are included in the 40) and a max
of 51 (if none of the 11 are included in the 40) images will be
transferred over. [1008] If there are superior as well as pelvic
and inferior views, these numbers range from (i.e. min is still 29,
but max is actually 153) [1009] A data structure needs to be
created that is a 5.times.8 array of pointers to image file names.
This contains the specific pointer to each of the min or max view
for each level. [1010] Vertebral body location data [1011] A
5.times.19 array needs to be created to contain the location data
for the four points of the two vertebral bodies [1012] 5=5 levels
[1013] 19=all views (the 11 specified views+8 min/max views) [1014]
Each element in the 5.times.19 array will have 2 sets of four (x,y)
coordinates (relative to the upper left corner of the image), one
set for the superior vertebral body, and one for the inferior
vertebral body.
[1015] Alterations to the System [1016] There can be a new user
type: system user [1017] Associated with a prescriber or a site
[1018] Multiple system users possible for each prescriber or site
[1019] The system user logs in via the portal, selects patients,
then get downloaded an encrypted zipped file containing a rendered
packet of data. Once the download is complete, the system records
that this has been downloaded. It can be re-downloaded as many
times as the user would like. [1020] The download packet itself is
a data structure that gets used by another program--the
system--that runs on an unconnected console computer. The detailed
data structure specification is given below: [1021] The system will
NOT render data packets if any of the following conditions apply.
The system will need to present an appropriate error message to the
user letting them know why the data packet cannot be rendered, and
what (if anything) can be done to remedy the situation: [1022]
Templates have NOT been confirmed. Please confirm templates [1023]
Patient has anomalous anatomy. This type of patient cannot be
processed using system. [1024] Incomplete data. The vertebral
motion analysis study was incomplete, and would need to be
reprocessed to include data that is currently missing to be able to
render a system file. [NOTE: All of the data listed below can be
present (i.e. no "n/r" is any cell). An exception is image data: If
all other data is complete but some expected views are missing,
then the data can be rendered.] [1025] A grid calibration was not
done in the vertebral motion analysis study, which may be used for
processing using system. The vertebral motion analysis study can be
re-run, reprocessed, and then a system file can be rendered. [1026]
A millimeter calibration marker was either not included, or was not
usable. The vertebral motion analysis study needs to be re-run,
reprocessed, and then a system file can be rendered.
[1027] In engaging the systems and methods according to aspects of
the disclosed subject matter the user may engage in one or more use
sessions. Each use session may include a training session and/or
surgical session. Additional data relating to performance may be
compared from one or more use sessions for application in other
surgical procedures.
[1028] A fourth aspect of the disclosure is a method of modeling
and projecting various loads across orthopedic implants prior to
and during surgery. An input to this system is data regarding the
position of patient spinal and other anatomy in various positions,
including those that represent target physical conditions such as
unassisted standing neutral postures. Knowing the spatial location
of this anatomy, especially when these locations incorporate data
that enables the anatomy to be placed in space relative to a
gravitational plumb line, can be used to project forces at a
specific level, and within a level at specific points. To acquire
this data relative to a plumb line, a measurement system is used
that incorporates an ability to image a plumb line, and that
incorporates the ability to derive positional data for each
vertebral body relative to this plumb line. See FIGS. 13A-C.
[1029] These forces can be projected using simple geometric
relationships which account for normal gravitational loads that
would occur, for example, during unassisted standing neutral
postures. These forces could then be differentially projected
post-operatively, assuming a specific type of geometry of the
surgical construct, then substituting the pre-operative geometry
with the assumed post-operative geometry at a surgical level, to
project a new spatial relationship between spinal levels, and thus
to project how forces may change as a consequence of the change in
geometry at the operated level.
[1030] These forces can be projected in other ways that
incorporates: (1) biomechanical modelling using standard
biomechanical modelling software, (2) additional patient-specific
parameters such as the cross sectional area of a muscle or muscle
group in radiographic images, other imaging parameters, surface
and/or needle electromyography and any associated measurements
(such as applied force during surface electromyogram (EMG) data
collection during isometric or isokinetic or some other form of
functional testing).
[1031] These forces can be projected in a way that is relative,
such that a single force measurement is given as a "high, medium,
or low". These groupings may be defined by user settable
thresholds. These forces will include sheer forces and compressive
forces, at the anterior margin and the posterior margin of the
implant (for a total of four force parameters. These force
projections may incorporate specific information about the
placement of a specific implant, such that intra-operatively
implant placement can be input into the system to determine if any
abnormally high forces are detected for a specific surgical
construct.
[1032] These forces projections may incorporate target surgical
construct geometry, as may be specified by a user in some way, to
project how forces would change and what type of forces may result
from a specific type of surgical construct.
[1033] The systems and methods according to aspects of the
disclosed subject matter may utilize a variety of computer and
computing systems, communications devices, networks and/or
digital/logic devices for operation. Each may, in turn, be
configurable to utilize a suitable computing device which can be
manufactured with, loaded with and/or fetch from some storage
device, and then execute, instructions that cause the computing
device to perform a method according to aspects of the disclosed
subject matter.
[1034] A computing device can include without limitation a desktop
computing device, a networked computing device, a mobile user
device such as a mobile phone, a smart phone and a cellular phone,
a personal digital assistant ("PDA"), a tablet, a laptop and the
like. In at least some configurations, a user can access and
manipulate data via a browser application over a network, such as
the Internet, to view and interact with digital content, such as
screen displays. A display includes, for example, an interface that
allows a visual presentation of data from a computing device.
Access could be over or partially over other forms of computing
and/or communications networks. A user may access a web-browser,
e.g., to provide access to applications and data and other content
located on a web-site or a web-page of a web-site.
[1035] A suitable computing device may include a processor to
perform logic and other computing operations, e.g., a stand-alone
computer processing unit ("CPU"), or hard wired logic as in a
microcontroller, or a combination of both, and may execute
instructions according to its operating system and the instructions
to perform the steps of the method, or elements of the process. The
user's computing device may be part of a network of computing
devices and the methods of the disclosed subject matter may be
performed by different computing devices associated with the
network, perhaps in different physical locations, cooperating or
otherwise interacting to perform a disclosed method. For example, a
user's portable computing device may run an app alone or in
conjunction with a remote computing device, such as a server on the
Internet. For purposes of the present application, the term
"computing device" includes any and all of the above discussed
logic circuitry, communications devices and digital processing
capabilities or combinations of these.
[1036] Certain embodiments of the disclosed subject matter may be
described for illustrative purposes as steps of a method which may
be executed on a computing device executing software, and
illustrated, by way of example only, as a block diagram of a
process flow. Such may also be considered as a software flow chart.
Such block diagrams and like operational illustrations of a method
performed or the operation of a computing device and any
combination of blocks in a block diagram, can illustrate, as
examples, software program code/instructions that can be provided
to the computing device or at least abbreviated statements of the
functionalities and operations performed by the computing device in
executing the instructions. Some possible alternate implementation
may involve the function, functionalities and operations noted in
the blocks of a block diagram occurring out of the order noted in
the block diagram, including occurring simultaneously or nearly so,
or in another order or not occurring at all. Aspects of the
disclosed subject matter may be implemented in parallel or seriatim
in hardware, firmware, software or any combination(s) of these,
co-located or remotely located, at least in part, from each other,
e.g., in arrays or networks of computing devices, over
interconnected networks, including the Internet, and the like.
[1037] The instructions may be stored on a suitable "machine
readable medium" within a computing device or in communication with
or otherwise accessible to the computing device. As used in the
present application a machine readable medium is a tangible storage
device and the instructions are stored in a non-transitory way. At
the same time, during operation, the instructions may at some times
be transitory, e.g., in transit from a remote storage device to a
computing device over a communication link. However, when the
machine readable medium is tangible and non-transitory, the
instructions will be stored, for at least some period of time, in a
memory storage device, such as a random access memory (RAM), read
only memory (ROM), a magnetic or optical disc storage device, or
the like, arrays and/or combinations of which may form a local
cache memory, e.g., residing on a processor integrated circuit, a
local main memory, e.g., housed within an enclosure for a processor
of a computing device, a local electronic or disc hard drive, a
remote storage location connected to a local server or a remote
server access over a network, or the like. When so stored, the
software will constitute a "machine readable medium," that is both
tangible and stores the instructions in a non-transitory form. At a
minimum, therefore, the machine readable medium storing
instructions for execution on an associated computing device will
be "tangible" and "non-transitory" at the time of execution of
instructions by a processor of a computing device and when the
instructions are being stored for subsequent access by a computing
device.
[1038] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. It should be understood that various alternatives to the
embodiments of the invention described herein may be employed in
practicing the invention. It is intended that the following claims
define the scope of the invention and that methods and structures
within the scope of these claims and their equivalents be covered
thereby.
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