U.S. patent application number 13/882022 was filed with the patent office on 2013-11-21 for methods, systems and devices for a clinical data reporting and surgical navigation.
This patent application is currently assigned to Ortho Kinematics, Inc.. The applicant listed for this patent is Adam Deitz, Richard K. Grant. Invention is credited to Adam Deitz, Richard K. Grant.
Application Number | 20130307955 13/882022 |
Document ID | / |
Family ID | 46245302 |
Filed Date | 2013-11-21 |
United States Patent
Application |
20130307955 |
Kind Code |
A1 |
Deitz; Adam ; et
al. |
November 21, 2013 |
METHODS, SYSTEMS AND DEVICES FOR A CLINICAL DATA REPORTING AND
SURGICAL NAVIGATION
Abstract
Three components are proposed, each having at its core a system
for producing measurements of the relative motion of anatomical
structures of mammals (the "measurement system"). The measurement
system in this case would be comprised of an apparatus for imaging
the joint of through a prescribed motion, and a process and
mechanism for deriving quantitative measurement output data from
the resulting images. The components of the present invention
include: (1) a software device for reporting measurement output of
the measurement system and for allowing users to interact with the
measurement output data; (2) an apparatus and method for utilizing
measurement output of the measurement system for therapeutic and
surgical applications such as surgical navigation and patient
positioning during a therapeutic procedure; and (3) an apparatus
providing input image data for the measurement system that assists
with the imaging of joints connecting anatomical regions that are
in motion during operation.
Inventors: |
Deitz; Adam; (Austin,
TX) ; Grant; Richard K.; (Sudbury, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Deitz; Adam
Grant; Richard K. |
Austin
Sudbury |
TX
MA |
US
US |
|
|
Assignee: |
Ortho Kinematics, Inc.,
Austin
TX
|
Family ID: |
46245302 |
Appl. No.: |
13/882022 |
Filed: |
December 12, 2011 |
PCT Filed: |
December 12, 2011 |
PCT NO: |
PCT/US11/64404 |
371 Date: |
July 16, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61422283 |
Dec 13, 2010 |
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61444265 |
Feb 18, 2011 |
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61451548 |
Mar 10, 2011 |
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61453236 |
Mar 16, 2011 |
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61454601 |
Mar 21, 2011 |
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61499272 |
Jun 21, 2011 |
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Current U.S.
Class: |
348/77 |
Current CPC
Class: |
G06T 7/11 20170101; A61B
34/20 20160201; A61B 5/1121 20130101; A61B 5/7278 20130101; A61B
5/107 20130101; A61B 5/4528 20130101; A61B 5/744 20130101; G16H
30/20 20180101; A61B 5/1071 20130101; A61B 5/1075 20130101; A61B
2034/107 20160201; A61B 5/4566 20130101; A61B 5/746 20130101; A61B
5/743 20130101; A61B 5/1079 20130101; A61B 5/1128 20130101; A61B
5/7275 20130101; A61F 2/44 20130101; H04N 7/183 20130101; H04N 7/18
20130101; G06T 2207/30012 20130101; A61B 5/06 20130101; A61B 5/7435
20130101; A61B 6/032 20130101; A61B 34/10 20160201; A61B 2034/105
20160201; G06T 7/0014 20130101; A61B 6/505 20130101; A61B 90/36
20160201; A61B 2034/2046 20160201; G06T 2207/10004 20130101; A61B
6/487 20130101 |
Class at
Publication: |
348/77 |
International
Class: |
H04N 7/18 20060101
H04N007/18 |
Claims
1-25. (canceled)
26. A system for evaluating kinematic data from a patient
comprising: an imaging system adapted to capture one or more images
of a target joint from a patient; a modeler adapted to provide a
model of a target biomechanical behavior for the target joint; a
comparer adapted to compare the one or more images of the target
joint with the computer implemented model and generate resulting
image.
27. The system of claim 26 further comprising a communication
network.
28. The system of claim 26 further comprising one or more of a
computer, a smart phone, and a tablet.
29. The system of claim 26 further comprising a database of
kinematic data.
30. The system of claim 26 further comprising a results viewer.
31. A system for obtaining kinematic data from a patient
comprising: an imaging system adapted to capture one or more images
of a target joint from a patient; an apparatus for measuring joint
motion comprising a passive motion device adapted and configured to
continuously move a joint of the subject through a range of motion,
the passive motion device further comprising, a platform base, and
a passive motion platform further comprising a static platform
connected to an upper surface of the platform base, a movable
platform connected to at least one of the static platform or an
upper surface of the platform base, wherein the static platform is
adjacent the movable platform wherein movement of the movable
platform is achieved in operation by a motor in communication with
the moveable platform, and an imaging device adapted and configured
to image the joint of the subject during the motion of the passive
motion device a comparer adapted to compare the one or more images
of the target joint with the computer implemented model.
32. The system of claim 31 further comprising a communication
network.
33. The system of claim 31 further comprising one or more of a
computer, a smart phone, and a tablet.
34. The system of claim 31 further comprising a database of
kinematic data.
35. The system of claim 31 further comprising a results viewer.
36. A surgical system comprising: an imaging system adapted to
capture one or more images of a target joint from a patient; an
apparatus for measuring joint motion comprising, a passive motion
device adapted and configured to continuously move a joint of the
subject through a range of motion, the passive motion device
further comprising, a platform base, and a passive motion platform
further comprising a static platform connected to an upper surface
of the platform base, a movable platform connected to at least one
of the static platform or an upper surface of the platform base,
wherein the static platform is adjacent the movable platform
wherein movement of the movable platform is achieved in operation
by a motor in communication with the moveable platform, and an
imaging device adapted and configured to image the joint of the
subject during the motion of the passive motion device; and a
device having a plurality of articulating arms having at least two
articulation joints, the articulating arms being adapted to be
inserted into an operative space and further adapted to
controllably articulate inside the operative space, with at least
three degrees of freedom of movement, at least one access port
adapted to receive the articulating arms, and a controller adapted
to control the articulation of the articulating arms inside the
operative space to perform a surgical procedure.
37. The system of claim 36 further comprising a communication
network.
38. The system of claim 36 further comprising one or more of a
computer, a smart phone, and a tablet.
39. The system of claim 36 further comprising a database of
kinematic data.
40. The system of claim 36 further comprising a results viewer.
41. An imaging system comprising: a motion device for continuously
moving a mammalian joint; an imaging device mounted to a free
floating, ballasted vertical plane, wherein the imaging device is
moveable relative to the motion device during use to maintain a
target anatomy within a targeted field of view; and a connector
adapted to connect the imaging device to the motion device such
that the imaging device and motion device move together when
activated.
42. The system of claim 41 further comprising one or more actuators
in communication with the processing system and adapted to
reposition the imaging device in response to the instruction.
43. The system of claim 41 further comprising one or more of each
of: a collimator, one or more motion sensors positionable on a
patient and in communication with one or more of the imaging device
and one or more re4cording sensors; and a processing system for
processing information from the one or more motion sensors to
generate an instruction.
44. The system of claim 43 further comprising one or more actuators
in communication with the processing system and adapted to
reposition the imaging device and motion device in response to an
instruction.
45. The system of claim 43 wherein the instruction is at least one
of automatically generated, semi-automatically generated, or
manually generated.
46. A method for computer-assisted analysis of kinematic data, the
method comprising: encoding a kinematic evaluation algorithm as one
or more decision trees, each decision tree further comprising one
or more decision points comprising one or more questions; and one
or more termination points, providing one or more images for a
patient from an imaging system; initiating an evaluation by
identifying one or more proposed procedures for the patient;
evaluating the proposed procedure applied to the one or more images
from the imaging system according to the algorithm; comparing the
evaluation of the proposed procedure to a user profile; and
providing a summary of one or more alerts for the one or more
proposed procedures based on the user profile and the one or more
patient images.
47. A method for computer-assisted analysis of kinematic data, the
method comprising: aggregating kinematic data from two or more
patients into a database; encoding a kinematic evaluation algorithm
as one or more decision trees, each decision tree further
comprising one or more decision points comprising one or more
questions; and one or more termination points, providing one or
more images for a patient from an imaging system according to the
algorithm; initiating an evaluation by identifying one or more
proposed procedures for the patient; evaluating the proposed
procedure applied to the one or more images from the imaging system
and the database of aggregated data; comparing the evaluation of
the proposed procedure to a user profile; and providing a summary
of one or more alerts for the one or more proposed procedures based
on the user profile and the one or more patient images.
Description
CROSS-REFERENCE
[0001] This application claims the benefit of U.S. Provisional
Application Nos. 61/422,283, filed Dec. 13, 2010, entitled Methods,
Systems and Devices for a Clinical Data Reporting Software System,
61/444,265 filed Feb. 18, 2011, entitled Methods, Systems and
Devices for A Clinical Data Reporting And Surgical Navigation,
61/453,236 filed Mar. 16, 2011 entitled Methods, Systems and
Devices for a Clinical Data Reporting Software System, 61/454,601
filed Mar. 21, 2011, entitled Methods, Systems and Devices for a
Clinical Data Reporting Software System and Product Design Tools,
and 61/499,272 filed Jun. 21, 2011, entitled Methods, Systems and
Devices for a Clinical Data Reporting and Surgical Navigation 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] U.S. Patent No. US 2004-0172145 A1 discloses a tilting table
capable of some movement to keep an iso-center at a fixed position.
U.S. Patent Publication No.: US 2006-0185091 A1 describes a
multi-articulated tilting table which positions and supports a
subject during examination and treatment. U.S. Pat. Publication No.
US 2005-0259794 A1 to Breen discloses a device for controlling
joint motion and minimizing the effects of muscle involvement in
the joint motion being studied. See also U.S. Pat. No. 7,502,641.
This device minimizes variability among joint motion measurements
across wide populations of subjects. As a result, comparative
analyses of such measurements can be performed to determine
statistical differences between the motion of "normal" and
"unhealthy" subjects which in turn can provide a basis for
determining the statistical confidence with which any given subject
could be considered "normal" or "unhealthy" based solely on joint
motion measurements. US 2009/0099481 A1 to Deitz for Devices,
Systems and Methods for Measuring and Evaluating the Motion and
Function of Joints and Associated Muscles discloses an apparatus
configured to cause and control joint motion of a patient.
[0005] New approaches that involve the use of patient positioning
devices during imaging discussed above, coupled with the use of
imaging modalities that afford for moving-video type images (such
as fluoroscopy) and automated computer image processing, have
created new clinical diagnostic capabilities. These capabilities
include the ability to produce low variability, quantitative
measurements of the relative motion between anatomical structures
in mammals, and in particular the ability to measure
inter-vertebral kinematics in live human subjects. These new
capabilities have been validated in clinical studies to
significantly outperform older methods, such as flexion/extension
X-rays, in determining whether or not a human spine joint has
dysfunctional motion. With the development of these new systems for
assessing inter-vertebral kinematics, there arises the need for
components to enable a number of clinical applications of this
newly-available diagnostic data.
[0006] One need is for new ways of viewing this new type of
kinematic data. Another need is for the ability to leverage this
data to improve upon the tools that users have in providing therapy
to patients. Yet another need is to be able to generate measurement
system results for anatomy that is typically hard or impossible to
image, such as anatomy that does not stay fixed in space during
operation, such as a knee (as opposed to a lumbar spine, which can
be easily imaged with a fixed imaging device).
SUMMARY OF THE INVENTION
[0007] Three components to the system are proposed, each component
is adapted and configured to work with a measurement system or
device for producing or obtaining measurements of a relative motion
of anatomical structures of mammals. The measurement system in this
case would be comprised of, for example, an apparatus for imaging a
target joint through a prescribed range of motion to obtain one or
more images, and a process or device for deriving quantitative
measurement output data from the images. The components of the
present disclosure include: (1) a software device having a user
interface which delivers data from the measurement system; (2) an
apparatus and method for utilizing measurement output of the
measurement system for therapeutic and surgical applications such
as surgical navigation and patient positioning during a therapeutic
procedure; and (3) an apparatus providing input image data for the
measurement system that assists with imaging during joint operation
to afford for the imaging of joints connecting anatomical regions
that are in motion during operation. The user is typically a
healthcare provider or clinician.
[0008] The first of these three components, the clinical data
reporting software interface, is an algorithm encoded in
computer-readable media which delivers to a user interface at least
one measurement output from the measurement system communicate
through the process of initialization by a user, interpretation of
results from the measurement system, and comparison with aggregated
data contained in the computer readable media. The software
interface is configured to operate in a communications network, and
with one or more input and output devices.
[0009] The clinical data reporting software interface allows the
user to initialize the system once prior to or during a first use
of the software interface to define, for example, a list of one or
more procedures of interest, one or more associated risks, and one
or more risk mitigation factors associated with each procedure. The
initialization information can be updated as often as desired,
and/or can be dynamically updated by communication with an service
provided. These risk and risk mitigation factors relate to the
appropriateness of a particular procedures in view of a specific
patient's presentations. The combination of risk and risk
mitigation factors are definable as specific alerts in the
reporting system that can be presented to the user for
consideration of changes to planned procedures for each patient
based on that patient's specific measurement system testing
results.
[0010] The clinical data reporting software interface integrates
user preferences for procedures of interest along with associated
risk factors and risk mitigation factors to facilitate
interpretation of patient specific results for specific kinematic
dysfunctions, at each spine level. Threshold limits for
quantitatively detecting kinematic dysfunctions can be set and
changed interactively by the user.
[0011] The clinical data reporting software interface provides a
process and mechanism for collecting additional data on each
subject to include: demographic, height/weight/other physical
measurements, subject history, symptoms, co-morbidities, neurologic
exam results, prior procedures performed and related outcome, and
others; as well as a process and device for transmitting this
additional data to an aggregated database.
[0012] The clinical data reporting software interface provides a
process and device for collecting aggregated data from all subjects
tested, creating a database that can be used for consideration and
comparison of outcomes for subjects matched based on: 1) kinematic
presentation, 2) additional data collected, and 3) procedure being
considered. User can view potential clinical outcomes of procedure
being considered by querying aggregated database.
[0013] The clinical data reporting software interface interprets
kinematic results of subjects that were tested in a standing or
lying down position, which allows for isolating the muscle or load
contribution, and additionally allowing for the use of this data
within a computer model of spine biomechanics that can further
isolate the potential muscular and soft tissue causes of any
functional problems.
[0014] The surgical navigation and patient positioning system is an
apparatus and method for utilizing measurement output of the
measurement system during therapeutic procedures. It comprises a
communications network, communication medium, input and output
devices, computing application and software application that
communicate and compute data through the process of acquisition of
data from the measurement system, processing of data to determine
appropriate target geometric and spatial parameters, communicating
this data to a surgical navigation system and/or a patient
positioning device (such as an intra-operative patient positioning
device).
[0015] The surgical navigation and patient positioning system
provides a mechanism to incorporate kinematic data into systems
used by users during therapeutic procedures, specifically surgical
navigation and surgical patient positioning systems. In the case of
surgical navigation, an apparatus and method are provided for
determining the optimal geometry for a surgical construct; such as
determining the optimal spatial relationships between and among an
inter-body device, posterior rods and screws, and two vertebral
endplates for spinal fusion surgical construct. Once determined,
the data describing this optimal geometry is then communicated to a
surgical navigation system and incorporated into the system's
targeting module, so that the surgical navigation system can be
used to assist the surgeon in achieving optimal geometry for the
surgical construct. In the case of patient positioning (such as
intra-operative patient positioning), an apparatus and method are
provided for determining and achieving the optimal positioning of
the patient on the procedure table. Once determined, the data
describing this optimal positioning of the patient is then
communicated to a surgical patient positioning system and
incorporated into the position control system so that the optimal
patient position can be achieved during surgery. The control system
can additionally be in communication with additional patient data
collection systems to provide real time feedback as to the effect
of patient positioning changes on the position, orientation, and
motion of the anatomy of interest, for the purpose of allowing the
control system to achieve the target anatomical geometry and
orientation by adjustments made to the surgical patient positioning
system.
[0016] The imaging system is adaptable to be moveable within a
vertical plane and is an apparatus providing input image data for
the measurement system that assists with imaging during joint
operation. It consists of a medical imaging system mounted to a
free floating, ballasted vertical plane, so that the medical
imaging system can be moved to keep joint anatomy within a moving
field of view, such as keeping a knee in a field of view as a live
human testing subject is walking. It incorporates motion recording
sensors position-able with respect to an image intensifier system
motion, with attachment mechanisms to engage the medical imaging
system or the recording sensors to piece of human anatomy. It may
additionally incorporate actuators capable of providing the motive
force to affect a repositioning of the medical imaging system.
[0017] Having an imaging system moveable within a vertical plane is
ideal for use with joints that connect two anatomical regions that
both move, such as the human knee that connects the tibia/fibula to
the femur, both of which are in motion during operation of the
knee. This is in contrast to joints where one of the two anatomical
regions connected by the joint stays relatively fixed, such as the
torso for shoulder rotation, or the pelvis for lumbar spine
rotation, and therefore can be imaged with a fixed imaging system
such that the joint stays in within the field of imaging during
operation. When both of the anatomical regions connected by a joint
are in motion, it can be impossible to keep that joint within a
field of view unless the imaging system is moving as well, which is
an operational objective of the imaging system moveable within a
vertical plane.
[0018] For all three of the components included in the present
disclosure, the inputs, information and reports can be transmitted
through either a direct wire-based electronic connection between
the two or more components, or through a wireless connection, and
can be of the type that is derived from computer programming or
from operator, user or subject input, or from a combination of
computer programmed information plus operator, user and/or subject
input. Those skilled in the art will appreciate that the system
described herein can be applied or incorporated into any
communications network, communication medium, input and output
devices and computing application available now and what will be
available in the future.
[0019] An aspect of the disclosure is directed to a method for
computer-assisted analysis of kinematic data. A method comprising,
for example, encoding a kinematic evaluation algorithm as one or
more decision trees, each decision tree further comprising, one or
more decision points comprising one or more questions; and one or
more termination points, providing one or more images for a patient
from an imaging system; initiating an evaluation by identifying one
or more proposed procedures for the patient; evaluating the
proposed procedure applied to the one or more images from the
imaging system according to the algorithm; comparing the evaluation
of the proposed procedure to a user profile; and providing a
summary of one or more alerts for the one or more proposed
procedures based on the user profile and the one or more patient
images. Additionally, the method can be performed on a
communication network. In some aspects, the method further
comprises the steps of: creating a user profile prior to the step
of providing one or more images from an imaging system wherein the
step of creating further comprises identifying one or more
procedures of interest for the user, creating one or more alerts
for the one or more procedures of interest based on a user
preference, wherein the alerts include one or more kinematic risk
factors and one or more kinematic mitigation factors. Additionally,
the one or more alerts can be based on one or more threshold limits
set by the user, either during the initiation process or during a
later adjustment. The method is adaptable such that the user an
user change the one or more threshold limits at any time, including
during evaluation of a particular patient's data. Typically, a
summary is provided to the user by a results viewer. In some
aspects, the additional steps of comparing the evaluation of the
proposed procedure to the updated one or more threshold limits and
providing an updated summary of one or more alerts for the one or
more proposed procedures is also contemplated. Additionally, one or
more alerts can be allocated a priority and, in at least some
configurations, the one or more alerts can be presented to the user
in a sort based on the allocated priority. Additionally, risk
mitigation factors are categorizable as at least one or more of
good, bad, and neutral. Moreover, in at least some aspects, the
summary is displayed on an electronic device screen and further
wherein the summary is displayed with one or more of each of
videos, images, and tables. Additionally, the step of evaluating
can further comprise evaluating one or more patient specific
parameters. In at least some situations, the one or more patient
specific parameters is one or more parameter selected from the
group comprising: demographics, height, weight, physical
measurements, health history, symptoms, neurological exam results,
co-morbidities.
[0020] Still another aspect of the disclosure is directed to a
method for computer-assisted analysis of kinematic data. The
computer-assisted method comprises, for example: aggregating
kinematic data from two or more patients into a database; encoding
a kinematic evaluation algorithm as one or more decision trees,
each decision tree further comprising, one or more decision points
comprising one or more questions; and one or more termination
points, providing one or more images for a patient from an imaging
system according to the algorithm; initiating an evaluation by
identifying one or more proposed procedures for the patient;
evaluating the proposed procedure applied to the one or more images
from the imaging system and the database of aggregated data;
comparing the evaluation of the proposed procedure to a user
profile; and providing a summary of one or more alerts for the one
or more proposed procedures based on the user profile and the one
or more patient images. Additionally, the method can be performed
on a communication network. In some aspects, the method further
comprises the steps of: creating a user profile prior to the step
of providing one or more images from an imaging system wherein the
step of creating further comprises identifying one or more
procedures of interest for the user, creating one or more alerts
for the one or more procedures of interest based on a user
preference, wherein the alerts include one or more kinematic risk
factors and one or more kinematic mitigation factors. Additionally,
the one or more alerts can be based on one or more threshold limits
set by the user, either during the initiation process or during a
later adjustment. The method is adaptable such that the user an
user change the one or more threshold limits at any time, including
during evaluation of a particular patient's data. Typically, a
summary is provided to the user by a results viewer. In some
aspects, the additional steps of comparing the evaluation of the
proposed procedure to the updated one or more threshold limits and
providing an updated summary of one or more alerts for the one or
more proposed procedures is also contemplated. Additionally, one or
more alerts can be allocated a priority and, in at least some
configurations, the one or more alerts can be presented to the user
in a sort based on the allocated priority. Additionally, risk
mitigation factors are categorizable as at least one or more of
good, bad, and neutral. Moreover, in at least some aspects, the
summary is displayed on an electronic device screen and further
wherein the summary is displayed with one or more of each of
videos, images, and tables. Additionally, the step of evaluating
can further comprise evaluating one or more patient specific
parameters. In at least some situations, the one or more patient
specific parameters is one or more parameter selected from the
group comprising: demographics, height, weight, physical
measurements, health history, symptoms, neurological exam results,
co-morbidities.
[0021] Yet another aspect of the disclosure is directed to a system
for evaluating kinematic data received from a patient. The system
comprises: an imaging system adapted to capture one or more images
of a target joint from a patient; a modeler adapted to provide a
model of a target biomechanical behavior for the target joint; a
comparer adapted to compare the one or more images of the target
joint with the computer implemented model and generate resulting
image. The system can include a communication network through which
various components of the system communicate. The system can
further comprising one or more of a computer, a smart phone, and a
tablet. Additionally, the system of claim can further include a
database of kinematic data. The database of kinematic data can be
from one or more patients. Additionally, a results viewer can be
provided.
[0022] In still another aspect of the disclosure, a system for
obtaining kinematic data from a patient is provided which
comprises: an imaging system adapted to capture one or more images
of a target joint from a patient; an apparatus for measuring joint
motion comprising, a passive motion device adapted and configured
to continuously move a joint of the subject through a range of
motion, the passive motion device further comprising, a platform
base, and a passive motion platform further comprising a static
platform connected to an upper surface of the platform base, a
movable platform connected to at least one of the static platform
or an upper surface of the platform base, wherein the static
platform is adjacent the movable platform wherein movement of the
movable platform is achieved in operation by a motor in
communication with the moveable platform, and an imaging device
adapted and configured to image the joint of the subject during the
motion of the passive motion device, a comparer adapted to compare
the one or more images of the target joint with the computer
implemented model. The system can include a communication network
through which various components of the system communicate. The
system can further comprising one or more of a computer, a smart
phone, and a tablet. Additionally, the system of claim can further
include a database of kinematic data. The database of kinematic
data can be from one or more patients. Additionally, a results
viewer can be provided.
[0023] Yet another aspect of the disclosure is directed to a
surgical system comprising: an imaging system adapted to capture
one or more images of a target joint from a patient; an apparatus
for measuring joint motion comprising, a passive motion device
adapted and configured to continuously move a joint of the subject
through a range of motion, the passive motion device further
comprising, a platform base, and a passive motion platform further
comprising a static platform connected to an upper surface of the
platform base, a movable platform connected to at least one of the
static platform or an upper surface of the platform base, wherein
the static platform is adjacent the movable platform wherein
movement of the movable platform is achieved in operation by a
motor in communication with the moveable platform, and an imaging
device adapted and configured to image the joint of the subject
during the motion of the passive motion device; and a device having
a plurality of articulating arms having at least two articulation
joints, the articulating arms being adapted to be inserted into an
operative space and further adapted to controllably articulate
inside the operative space, with at least three degrees of freedom
of movement, at least one access port adapted to receive the
articulating arms, and a controller adapted to control the
articulation of the articulating arms inside the operative space to
perform a surgical procedure. The system can include a
communication network through which various components of the
system communicate. The system can further comprising one or more
of a computer, a smart phone, and a tablet. Additionally, the
system of claim can further include a database of kinematic data.
The database of kinematic data can be from one or more patients.
Additionally, a results viewer can be provided.
[0024] An aspect of the disclosure is directed to a method for
computer-assisted analysis of kinematic data. Methods comprise:
encoding a kinematic evaluation algorithm as one or more decision
trees, each decision tree further comprising, one or more decision
points comprising one or more questions; and one or more
termination points, providing one or more images for a patient from
an imaging system; initiating an evaluation by identifying one or
more proposed procedures for the patient; evaluating the proposed
procedure applied to the one or more images from the imaging system
according to the algorithm; comparing the evaluation of the
proposed procedure to a user profile; and providing a summary of
one or more alerts for the one or more proposed procedures based on
the user profile and the one or more patient images. Additionally
the method can be performed on a communication network, such as the
Internet or an intranet using wired and wireless capability.
Additional method steps can include, creating a user profile prior
to the step of providing one or more images from an imaging system
wherein the step of creating further comprises identifying one or
more procedures of interest for the user, creating one or more
alerts for the one or more procedures of interest based on a user
preference, wherein the alerts include one or more kinematic risk
factors and one or more kinematic mitigation factors. In at least
some instances, one or more alerts can be issued based on one or
more threshold limits set by the user. Users can also change the
one or more threshold limits either at a mail profile (thus
impacting all cases or all future cases evaluated) or for a
specific case. Additionally, the summary is provided to the user by
a results viewer. Additionally, the method can include comparing
the evaluation of the proposed procedure to the updated one or more
threshold limits and providing an updated summary of one or more
alerts for the one or more proposed procedures. Moreover, the one
or more alerts are allocated a priority and further wherein the one
or more alerts are sorted based on the allocated priority. In some
aspects, the risk mitigation factors are categorizable as at least
one or more of good, bad, and neutral. Additionally, the summary is
displayed on an electronic device screen and further wherein the
summary is displayed with one or more of each of videos, images,
and tables. The step of evaluating can further comprise evaluating
one or more patient specific parameters. Suitable patient
parameters include, for example, one or more parameter selected
from the group comprising: demographics, height, weight, physical
measurements, health history, symptoms, neurological exam results,
co-morbidities.
[0025] Another aspect of the disclosure is directed to a method for
computer-assisted analysis of kinematic data where the method
comprises: aggregating kinematic data from two or more patients
into a database; encoding a kinematic evaluation algorithm as one
or more decision trees, each decision tree further comprising, one
or more decision points comprising one or more questions; and one
or more termination points, providing one or more images for a
patient from an imaging system according to the algorithm;
initiating an evaluation by identifying one or more proposed
procedures for the patient; evaluating the proposed procedure
applied to the one or more images from the imaging system and the
database of aggregated data; comparing the evaluation of the
proposed procedure to a user profile; and providing a summary of
one or more alerts for the one or more proposed procedures based on
the user profile and the one or more patient images. Additionally
the method can be performed on a communication network, such as the
Internet or an intranet using wired and wireless capability.
Additional method steps can include, creating a user profile prior
to the step of providing one or more images from an imaging system
wherein the step of creating further comprises identifying one or
more procedures of interest for the user, creating one or more
alerts for the one or more procedures of interest based on a user
preference, wherein the alerts include one or more kinematic risk
factors and one or more kinematic mitigation factors. In at least
some instances, one or more alerts can be issued based on one or
more threshold limits set by the user. Users can also change the
one or more threshold limits either at a mail profile (thus
impacting all cases or all future cases evaluated) or for a
specific case. Additionally, the summary is provided to the user by
a results viewer. Additionally, the method can include comparing
the evaluation of the proposed procedure to the updated one or more
threshold limits and providing an updated summary of one or more
alerts for the one or more proposed procedures. Moreover, the one
or more alerts are allocated a priority and further wherein the one
or more alerts are sorted based on the allocated priority. In some
aspects, the risk mitigation factors are categorizable as at least
one or more of good, bad, and neutral. Additionally, the summary is
displayed on an electronic device screen and further wherein the
summary is displayed with one or more of each of videos, images,
and tables. The step of evaluating can further comprise evaluating
one or more patient specific parameters. Suitable patient
parameters include, for example, one or more parameter selected
from the group comprising: demographics, height, weight, physical
measurements, health history, symptoms, neurological exam results,
co-morbidities.
[0026] Still another aspect of the disclosure is directed to a
system for evaluating kinematic data from a patient. A suitable
system comprises: an imaging system adapted to capture one or more
images of a target joint from a patient; a modeler adapted to
provide a model of a target biomechanical behavior for the target
joint; a comparer adapted to compare the one or more images of the
target joint with the computer implemented model and generate
resulting image. The system can further be configured to operate on
or in conjunction with a communication network, such as the
Internet or an intranet using wired and wireless capability.
Additionally, the system can employ one or more of a computer, a
smart phone, and a tablet. Additionally, the system can create,
access, and/or maintain a database of kinematic data. A results
viewer can also be provided.
[0027] Yet another aspect of the disclosure is directed to a system
for obtaining kinematic data from a patient wherein the system
comprises: an imaging system adapted to capture one or more images
of a target joint from a patient; an apparatus for measuring joint
motion comprising a passive motion device adapted and configured to
continuously move a joint of the subject through a range of motion,
the passive motion device further comprising, a platform base, and
a passive motion platform further comprising a static platform
connected to an upper surface of the platform base, a movable
platform connected to at least one of the static platform or an
upper surface of the platform base, wherein the static platform is
adjacent the movable platform wherein movement of the movable
platform is achieved in operation by a motor in communication with
the moveable platform, and an imaging device adapted and configured
to image the joint of the subject during the motion of the passive
motion device a comparer adapted to compare the one or more images
of the target joint with the computer implemented model. The system
can further be configured to operate on or in conjunction with a
communication network, such as the Internet or an intranet using
wired and wireless capability. Additionally, the system can employ
one or more of a computer, a smart phone, and a tablet.
Additionally, the system can create, access, and/or maintain a
database of kinematic data. A results viewer can also be
provided.
[0028] Another aspect of the disclosure is directed to a surgical
system. The surgical system comprises, for example, an imaging
system adapted to capture one or more images of a target joint from
a patient; an apparatus for measuring joint motion comprising, a
passive motion device adapted and configured to continuously move a
joint of the subject through a range of motion, the passive motion
device further comprising, a platform base, and a passive motion
platform further comprising a static platform connected to an upper
surface of the platform base, a movable platform connected to at
least one of the static platform or an upper surface of the
platform base, wherein the static platform is adjacent the movable
platform wherein movement of the movable platform is achieved in
operation by a motor in communication with the moveable platform,
and an imaging device adapted and configured to image the joint of
the subject during the motion of the passive motion device; and a
device having a plurality of articulating arms having at least two
articulation joints, the articulating arms being adapted to be
inserted into an operative space and further adapted to
controllably articulate inside the operative space, with at least
three degrees of freedom of movement, at least one access port
adapted to receive the articulating arms, and a controller adapted
to control the articulation of the articulating arms inside the
operative space to perform a surgical procedure. The surgical
system can further be configured to operate on or in conjunction
with a communication network, such as the Internet or an intranet
using wired and wireless capability. Additionally, the surgical
system can employ one or more of a computer, a smart phone, and a
tablet. Additionally, the surgical system can create, access,
and/or maintain a database of kinematic data. A results viewer can
also be provided.
[0029] An additional aspect of the disclosure is directed to an
imaging system comprising: a motion device for continuously moving
a mammalian joint; an imaging device mounted to a free floating,
ballasted vertical plane, wherein the imaging device is moveable
relative to the motion device during use to maintain a target
anatomy within a targeted field of view; and a connector adapted to
connect the imaging device to the motion device such that the
imaging device and motion device move together when activated. One
or more actuators can also be provided that are in communication
with the processing system and adapted to reposition the imaging
device in response to the instruction. Additionally, a collimator
can be included. In some configurations, the system comprises one
or more motion sensors positionable on a patient and in
communication with one or more of the imaging device and one or
more recording sensors. In still other configurations, a processing
system for processing information from the one or more motion
sensors to generate an instruction is provided. Additionally, one
or more actuators in communication with the processing system and
adapted to reposition the imaging device and motion device in
response to an instruction can be provided. In some configurations,
the instruction is at least one of automatically generated,
semi-automatically generated, or manually generated, or
combinations thereof. Moreover, the connector can be a connection
rod.
INCORPORATION BY REFERENCE
[0030] 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.
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] 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:
[0032] FIG. 1A is a lateral view of a normal human spinal column;
FIG. 1B is illustrates a human body with the planes of the body
identified;
[0033] FIG. 2A is a block diagram showing a representative example
of a logic device through which clinical data reporting can be
achieved;
[0034] FIG. 2B is a block diagram of an exemplary computing
environment through which the clinical data reporting software
interface and the surgical navigation and patient positioning can
be achieved;
[0035] FIG. 2C is an illustrative architectural diagram showing
some structure that can be employed by devices through which the
clinical data reporting software interface and the surgical
navigation and patient positioning can be achieved;
[0036] FIG. 3 is an exemplary diagram of a server in an
implementation suitable for use in a system where the clinical data
reporting software interface and the surgical navigation and
patient positioning can be achieved;
[0037] FIG. 4 is an exemplary diagram of a master system in an
implementation suitable for use in a system where the clinical data
reporting software interface and the surgical navigation and
patient positioning can be achieved;
[0038] FIG. 5 is a block diagram showing the cooperation of
exemplary components of a system suitable for use in a system where
the clinical data reporting software interface and the surgical
navigation and patient positioning can be achieved;
[0039] FIG. 6 is a simplified block diagram of an initialization
step for the clinical data reporting software interface. This
initialization step is performed once by a user prior to a first
use, and can be updated as needed. In this step the user defines a
list of procedures of interest and associated alerts based on risk
factors and risk mitigation factors;
[0040] FIG. 7a is a simplified block diagram of a step for
interpreting response the clinical data reporting software
interface. This step is performed when a subject undergoes
kinematic testing. Results which indicate specific kinematic
dysfunctions detected at, for example, each spine level are
interpreted based on threshold limits which are set and changed
interactively by the user;
[0041] FIGS. 7b and 7c illustrate pages a first and second page of
a two-page example of one embodiment of the type of data collected
as part of the initialization step that each user undergoes prior
to using the clinical data reporting software interface;
[0042] FIG. 7d illustrates a screen shot of how alerts can be
configured during the initialization process and then subsequently
changed by the user using the clinical data reporting software
interface;
[0043] FIG. 7e illustrates types of alerts that, for example, a
spine surgeon may want to be warned about using the clinical data
reporting software interface;
[0044] FIG. 7f illustrates a screen shot for viewing results
including moving video images along with templates, graph, and
numeric data; that can be part of the results viewing capability of
the clinical data reporting software interface;
[0045] FIG. 7g is a screen shot illustrating the results viewing
capability of the clinical data reporting software interface, which
facilitates a user's interaction with quantitative data regarding
the detection of specific kinematic dysfunctions;
[0046] FIG. 7h is an example screen shot that illustrates the
capability for viewing and interacting with surgeon alerts, as part
of an alerts capability of the clinical data reporting software
interface;
[0047] FIG. 8a is a block diagram outlining a process within the
clinical data reporting software interface for creating a
centralized aggregate database allowing for data input, viewing and
querying that can be used for consideration and comparison of
patient outcomes;
[0048] FIGS. 8b, 8c, and 8d are three screens shot that illustrate
how a user of the clinical data reporting software would interact
with the system to input data, view, and query the aggregated
database. In FIG. 8b, a user interface is shown. In FIG. 8c a
method for inputting neurological exam results into the aggregated
database is shown. FIG. 8d a method for inputting a patient's pain
scores into the aggregated database, as well as functionality that
enables a user to select among various outcomes assessments to be
output, are shown.
[0049] FIG. 9 is a block diagram outlining a process within the
clinical data reporting software interface of interacting with a
computer model of spine biomechanics based on patient-specific
kinematic test data collected from subjects in a standing or lying
down position, allowing for isolating muscle or load contribution
which can help users further isolate the potential causes of joint
pain or performance problems;
[0050] FIG. 10 is a block diagram showing system components and
inter-connections of a surgical navigation and patient positioning
system;
[0051] FIG. 11 is an illustration of a center of rotation report
for a single level in the spinal column, which could come from the
measurement system and be used as a parameter in optimizing the
balance of the spine post-operatively via deterministic geometry
and orientation of a surgical construct accomplishable via a
surgical navigation system working in combination with the surgical
navigation and patient positioning components;
[0052] FIG. 12 is a table illustrating ways in which functional
targets could be clinically useful in a surgical navigation system,
as enabled via the surgical navigation and patient positioning;
[0053] FIG. 13 illustrates a first step of a two step process for
achieving position and geometry of a spine fusion surgical
construct via the surgical navigation and patient positioning;
and
[0054] FIG. 14 illustrates a second step of a two step process for
achieving position and geometry of a spine fusion surgical
construct via the surgical navigation and patient positioning;
and
[0055] FIG. 15 is a block diagram of an imaging system moveable
within a vertical plane, operating in manual mode;
[0056] FIG. 16 is a block diagram of an imaging system moveable
within a vertical plane, operating in automatic mode; and
[0057] FIGS. 17A-B illustrate the functionality of a collimator
device and a collimator in conjunction with a patient examination
table suitable for use with this system.
DETAILED DESCRIPTION OF THE INVENTION
I. Anatomical Context
[0058] FIG. 1 illustrates the human spinal column 10 which is
comprised of a series of thirty-three stacked vertebrae 12 divided
into five regions. The cervical region includes seven vertebrae,
known as C1-C7. The thoracic region includes twelve vertebrae,
known as T1-T12. The lumbar region contains five vertebrae, known
as L1-L5. The sacral region is comprised of five fused vertebrae,
known as S1-S5, while the coccygeal region contains four fused
vertebrae, known as Co1-Co4.
[0059] In order to understand the configurability, adaptability,
and operational aspects of the systems, methods and devices
disclosed herein, it is helpful to understand the anatomical
references of the body 50 with respect to which the position and
operation of the devices, and components thereof, are described. As
shown in FIG. 1B, there are three anatomical planes generally used
in anatomy to describe the human body and structure within the
human body: the axial plane 52, the sagittal plane 54 and the
coronal plane 56. Additionally, devices and the operation of
devices and tools may be better understood with respect to the
caudad 60 direction and/or the cephalad direction 62. Devices and
tools can be positioned dorsally 70 (or posteriorly) such that the
placement or operation of the device is toward the back or rear of
the body. Alternatively, devices can be positioned ventrally 72 (or
anteriorly) such that the placement or operation of the device is
toward the front of the body. Various embodiments of the devices,
systems and tools of the present disclosure may be configurable and
variable with respect to a single anatomical plane or with respect
to two or more anatomical planes. For example, a subject or a
feature of the device may be described as lying within and having
adaptability or operability in relation to a single plane. A device
may be positioned in a desired location relative to a sagittal
plane and may be moveable between a number of adaptable positions
or within a range of positions.
[0060] For purposes of illustration, the devices and methods of the
disclosure are described below with reference to the spine of the
human body. However, as will be appreciation by those skilled in
the art, the devices and methods can be employed to address any
effected bone or joint, including, for example, the hip, the knee,
the ankle, the wrist, the elbow, and the shoulder. Additionally,
the devices and methods can also be employed with any mammal.
II. Computing Systems
[0061] The systems and methods described herein rely on a variety
of computer systems, networks and/or digital devices for operation.
In order to fully appreciate how the system operates an
understanding of suitable computing systems is useful. The systems
and methods disclosed herein are enabled as a result of application
via a suitable computing system.
[0062] FIG. 2A is a block diagram showing a representative example
logic device through which a browser can be accessed to implement
the present disclosure. A computer system (or digital device) 100,
which may be understood as a logic apparatus adapted and configured
to read instructions from media 114 and/or network port 106, is
connectable to a server 110, and has a fixed media 116. The
computer system 100 can also be connected to the Internet or an
intranet. The system includes central processing unit (CPU) 102,
disk drives 104, optional input devices, illustrated as keyboard
118 and/or mouse 120 and optional monitor 108. Data communication
can be achieved through, for example, communication medium 109 to a
server 110 at a local or a remote location. The communication
medium 109 can include any suitable mechanism for transmitting
and/or receiving data. For example, the communication medium can be
a network connection, a wireless connection or an internet
connection. It is envisioned that data relating to the present
disclosure can be transmitted over such networks or connections.
The computer system can be adapted to communicate with a
participant and/or a device used by a participant. The computer
system is adaptable to communicate with other computers over the
Internet, or with computers via a server.
[0063] FIG. 2B depicts another exemplary computing system 100. The
computing system 100 is capable of executing a variety of computing
applications 138, including computing applications, a computing
applet, a computing program, or other instructions for operating on
computing system 100 to perform at least one function, operation,
and/or procedure. Computing system 100 is controllable by computer
readable storage media for tangibly storing computer readable
instructions, which may be in the form of software. The computer
readable storage media adapted to tangibly store computer readable
instructions can contain instructions for computing system 100 for
storing and accessing the computer readable storage media to read
the instructions stored thereon themselves. Such software may be
executed within CPU 102 to cause the computing system 100 to
perform desired functions. In many known computer servers,
workstations and personal computers CPU 102 is implemented by
micro-electronic chips CPUs called microprocessors. Optionally, a
co-processor, distinct from the main CPU 102, can be provided that
performs additional functions or assists the CPU 102. The CPU 102
may be connected to co-processor through an interconnect. One
common type of coprocessor is the floating-point coprocessor, also
called a numeric or math coprocessor, which is designed to perform
numeric calculations faster and better than the general-purpose CPU
102.
[0064] As will be appreciated by those skilled in the art, a
computer readable medium stores computer data, which data can
include computer program code that is executable by a computer, in
machine readable form. By way of example, and not limitation, a
computer readable medium may comprise computer readable storage
media, for tangible or fixed storage of data, or communication
media for transient interpretation of code-containing signals.
Computer readable storage media, as used herein, refers to physical
or tangible storage (as opposed to signals) and includes without
limitation volatile and non-volatile, removable and non-removable
storage media implemented in any method or technology for the
tangible storage of information such as computer-readable
instructions, data structures, program modules or other data.
Computer readable storage media includes, but is not limited to,
RAM, ROM, EPROM, EEPROM, flash memory or other solid state memory
technology, CD-ROM, DVD, or other optical storage, magnetic
cassettes, magnetic tape, magnetic disk storage or other magnetic
storage devices, or any other physical or material medium which can
be used to tangibly store the desired information or data or
instructions and which can be accessed by a computer or
processor
[0065] In operation, the CPU 102 fetches, decodes, and executes
instructions, and transfers information to and from other resources
via the computer's main data-transfer path, system bus 140. Such a
system bus connects the components in the computing system 100 and
defines the medium for data exchange. Memory devices coupled to the
system bus 140 include random access memory (RAM) 124 and read only
memory (ROM) 126. Such memories include circuitry that allows
information to be stored and retrieved. The ROMs 126 generally
contain stored data that cannot be modified. Data stored in the RAM
124 can be read or changed by CPU 102 or other hardware devices.
Access to the RAM 124 and/or ROM 126 may be controlled by memory
controller 122. The memory controller 122 may provide an address
translation function that translates virtual addresses into
physical addresses as instructions are executed.
[0066] In addition, the computing system 100 can contain
peripherals controller 128 responsible for communicating
instructions from the CPU 102 to peripherals, such as, printer 142,
keyboard 118, mouse 120, and data storage drive 143. Display 108,
which is controlled by a display controller 163, is used to display
visual output generated by the computing system 100. Such visual
output may include text, graphics, animated graphics, and video.
The display controller 134 includes electronic components required
to generate a video signal that is sent to display 108. Further,
the computing system 100 can contain network adaptor 136 which may
be used to connect the computing system 100 to an external
communications network 132.
III. Networks and Internet Protocol
[0067] As is well understood by those skilled in the art, the
Internet is a worldwide network of computer networks. Today, the
Internet is a public and self-sustaining network that is available
to many millions of users. The Internet uses a set of communication
protocols called TCP/IP (i.e., Transmission Control
Protocol/Internet Protocol) to connect hosts. The Internet has a
communications infrastructure known as the Internet backbone.
Access to the Internet backbone is largely controlled by Internet
Service Providers (ISPs) that resell access to corporations and
individuals.
[0068] The Internet Protocol (IP) enables data to be sent from one
device (e.g., a phone, a Personal Digital Assistant (PDA), a
computer, etc.) to another device on a network. There are a variety
of versions of IP today, including, e.g., IPv4, IPv6, etc. Other
IPs are no doubt available and will continue to become available in
the future, any of which can be used without departing from the
scope of the disclosure. Each host device on the network has at
least one IP address that is its own unique identifier and acts as
a connectionless protocol. The connection between end points during
a communication is not continuous. When a user sends or receives
data or messages, the data or messages are divided into components
known as packets. Every packet is treated as an independent unit of
data and routed to its final destination--but not necessarily via
the same path.
[0069] The Open System Interconnection (OSI) model was established
to standardize transmission between points over the Internet or
other networks. The OSI model separates the communications
processes between two points in a network into seven stacked
layers, with each layer adding its own set of functions. Each
device handles a message so that there is a downward flow through
each layer at a sending end point and an upward flow through the
layers at a receiving end point. The programming and/or hardware
that provides the seven layers of function is typically a
combination of device operating systems, application software,
TCP/IP and/or other transport and network protocols, and other
software and hardware.
[0070] Typically, the top four layers are used when a message
passes from or to a user and the bottom three layers are used when
a message passes through a device (e.g., an IP host device). An IP
host is any device on the network that is capable of transmitting
and receiving IP packets, such as a server, a router or a
workstation. Messages destined for some other host are not passed
up to the upper layers but are forwarded to the other host. The
layers of the OSI model are listed below. Layer 7 (i.e., the
application layer) is a layer at which, e.g., communication
partners are identified, quality of service is identified, user
authentication and privacy are considered, constraints on data
syntax are identified, etc. Layer 6 (i.e., the presentation layer)
is a layer that, e.g., converts incoming and outgoing data from one
presentation format to another, etc. Layer 5 (i.e., the session
layer) is a layer that, e.g., sets up, coordinates, and terminates
conversations, exchanges and dialogs between the applications, etc.
Layer-4 (i.e., the transport layer) is a layer that, e.g., manages
end-to-end control and error-checking, etc. Layer-3 (i.e., the
network layer) is a layer that, e.g., handles routing and
forwarding, etc. Layer-2 (i.e., the data-link layer) is a layer
that, e.g., provides synchronization for the physical level, does
bit-stuffing and furnishes transmission protocol knowledge and
management, etc. The Institute of Electrical and Electronics
Engineers (IEEE) sub-divides the data-link layer into two further
sub-layers, the MAC (Media Access Control) layer that controls the
data transfer to and from the physical layer and the LLC (Logical
Link Control) layer that interfaces with the network layer and
interprets commands and performs error recovery. Layer 1 (i.e., the
physical layer) is a layer that, e.g., conveys the bit stream
through the network at the physical level. The IEEE sub-divides the
physical layer into the PLCP (Physical Layer Convergence Procedure)
sub-layer and the PMD (Physical Medium Dependent) sub-layer.
IV. Wireless Networks
[0071] Wireless networks can incorporate a variety of types of
mobile devices, such as, e.g., cellular and wireless telephones,
PCs (personal computers), laptop computers, wearable computers,
cordless phones, pagers, headsets, printers, PDAs, etc. For
example, mobile devices may include digital systems to secure fast
wireless transmissions of voice and/or data. Typical mobile devices
include some or all of the following components: a transceiver (for
example a transmitter and a receiver, including a single chip
transceiver with an integrated transmitter, receiver and, if
desired, other functions); an antenna; a processor; display; one or
more audio transducers (for example, a speaker or a microphone as
in devices for audio communications); electromagnetic data storage
(such as ROM, RAM, digital data storage, etc., such as in devices
where data processing is provided); memory; flash memory; and/or a
full chip set or integrated circuit; interfaces (such as universal
serial bus (USB), coder-decoder (CODEC), universal asynchronous
receiver-transmitter (UART), phase-change memory (PCM), etc.).
Other components can be provided without departing from the scope
of the disclosure.
[0072] Wireless LANs (WLANs) in which a mobile user can connect to
a local area network (LAN) through a wireless connection may be
employed for wireless communications. Wireless communications can
include communications that propagate via electromagnetic waves,
such as light, infrared, radio, and microwave. There are a variety
of WLAN standards that currently exist, such as Bluetooth.RTM.,
IEEE 802.11, and the obsolete HomeRF.
[0073] By way of example, Bluetooth products may be used to provide
links between mobile computers, mobile phones, portable handheld
devices, personal digital assistants (PDAs), and other mobile
devices and connectivity to the Internet. Bluetooth is a computing
and telecommunications industry specification that details how
mobile devices can easily interconnect with each other and with
non-mobile devices using a short-range wireless connection.
Bluetooth creates a digital wireless protocol to address end-user
problems arising from the proliferation of various mobile devices
that need to keep data synchronized and consistent from one device
to another, thereby allowing equipment from different vendors to
work seamlessly together.
[0074] An IEEE standard, IEEE 802.11, specifies technologies for
wireless LANs and devices. Using 802.11, wireless networking may be
accomplished with each single base station supporting several
devices. In some examples, devices may come pre-equipped with
wireless hardware or a user may install a separate piece of
hardware, such as a card, that may include an antenna. By way of
example, devices used in 802.11 typically include three notable
elements, whether or not the device is an access point (AP), a
mobile station (STA), a bridge, a personal computing memory card
International Association (PCMCIA) card (or PC card) or another
device: a radio transceiver; an antenna; and a MAC (Media Access
Control) layer that controls packet flow between points in a
network.
[0075] In addition, Multiple Interface Devices (MIDs) may be
utilized in some wireless networks. MIDs may contain two
independent network interfaces, such as a Bluetooth interface and
an 802.11 interface, thus allowing the MID to participate on two
separate networks as well as to interface with Bluetooth devices.
The MID may have an IP address and a common IP (network) name
associated with the IP address.
[0076] Wireless network devices may include, but are not limited to
Bluetooth devices, WiMAX (Worldwide Interoperability for Microwave
Access), Multiple Interface Devices (MIDs), 802.11x devices (IEEE
802.11 devices including, 802.11a, 802.11b and 802.11g devices),
HomeRF (Home Radio Frequency) devices, Wi-Fi (Wireless Fidelity)
devices, GPRS (General Packet Radio Service) devices, 3 G cellular
devices, 2.5 G cellular devices, GSM (Global System for Mobile
Communications) devices, EDGE (Enhanced Data for GSM Evolution)
devices, TDMA type (Time Division Multiple Access) devices, or CDMA
type (Code Division Multiple Access) devices, including CDMA2000.
Each network device may contain addresses of varying types
including but not limited to an IP address, a Bluetooth Device
Address, a Bluetooth Common Name, a Bluetooth IP address, a
Bluetooth IP Common Name, an 802.11 IP Address, an 802.11 IP common
Name, or an IEEE MAC address.
[0077] Wireless networks can also involve methods and protocols
found in, Mobile IP (Internet Protocol) systems, in PCS systems,
and in other mobile network systems. With respect to Mobile IP,
this involves a standard communications protocol created by the
Internet Engineering Task Force (IETF). With Mobile IP, mobile
device users can move across networks while maintaining their IP
Address assigned once. See Request for Comments (RFC) 3344. NB:
RFCs are formal documents of the Internet Engineering Task Force
(IETF). Mobile IP enhances Internet Protocol (IP) and adds a
mechanism to forward Internet traffic to mobile devices when
connecting outside their home network. Mobile IP assigns each
mobile node a home address on its home network and a
care-of-address (CoA) that identifies the current location of the
device within a network and its subnets. When a device is moved to
a different network, it receives a new care-of address. A mobility
agent on the home network can associate each home address with its
care-of address. The mobile node can send the home agent a binding
update each time it changes its care-of address using Internet
Control Message Protocol (ICMP).
[0078] In basic IP routing (e.g., outside mobile IP), routing
mechanisms rely on the assumptions that each network node has a
constant attachment point to the Internet and that each node's IP
address identifies the network link it is attached to. In this
document, the terminology "node" includes a connection point, which
can include a redistribution point or an end point for data
transmissions, and which can recognize, process and/or forward
communications to other nodes. For example, Internet routers can
look at an IP address prefix or the like identifying a device's
network. Then, at a network level, routers can look at a set of
bits identifying a particular subnet. Then, at a subnet level,
routers can look at a set of bits identifying a particular device.
With typical mobile IP communications, if a user disconnects a
mobile device from the Internet and tries to reconnect it at a new
subnet, then the device has to be reconfigured with a new IP
address, a proper netmask and a default router. Otherwise, routing
protocols would not be able to deliver the packets properly.
[0079] FIG. 2C depicts components that can be employed in system
configurations enabling the systems and technical effect of this
disclosure, including wireless access points to which client
devices communicate. In this regard, FIG. 2C shows a wireless
network 150 connected to a wireless local area network (WLAN) 152.
The WLAN 152 includes an access point (AP) 154 and a number of user
stations 156, 156'. For example, the network 150 can include the
Internet or a corporate data processing network. The access point
154 can be a wireless router, and the user stations 156, 156' can
be portable computers, personal desk-top computers, PDAs, portable
voice-over-IP telephones and/or other devices. The access point 154
has a network interface 158 linked to the network 150, and a
wireless transceiver in communication with the user stations 156,
156'. For example, the wireless transceiver 160 can include an
antenna 162 for radio or microwave frequency communication with the
user stations 156, 156'. The access point 154 also has a processor
164, a program memory 166, and a random access memory 168. The user
station 156 has a wireless transceiver 170 including an antenna 172
for communication with the access point station 154. In a similar
fashion, the user station 156' has a wireless transceiver 170' and
an antenna 172 for communication to the access point 154. By way of
example, in some embodiments an authenticator could be employed
within such an access point (AP) and/or a supplicant or peer could
be employed within a mobile node or user station. Desktop 108 and
key board 118 or input devices can also be provided with the user
status.
V. Media Independent Handover Services
[0080] In IEEE P802.21/D.01.09, September 2006, entitled Draft IEEE
Standard for Local and Metropolitan Area Networks: Media
Independent Handover Services, among other things, the document
specifies 802 media access-independent mechanisms that optimize
handovers between 802 systems and cellular systems. The IEEE 802.21
standard defines extensible media access independent mechanisms
that enable the optimization of handovers between heterogeneous 802
systems and may facilitate handovers between 802 systems and
cellular systems. "The scope of the IEEE 802.21 (Media Independent
Handover) standard is to develop a specification that provides link
layer intelligence and other related network information to upper
layers to optimize handovers between heterogeneous media. This
includes links specified by 3GPP, 3GPP2 and both wired and wireless
media in the IEEE 802 family of standards. Note, in this document,
unless otherwise noted, "media" refers to method/mode of accessing
a telecommunication system (e.g. cable, radio, satellite, etc.), as
opposed to sensory aspects of communication (e.g. audio, video,
etc.)." See 1.1 of I.E.E.E. P802.21/D.01.09, September 2006,
entitled Draft IEEE Standard for Local and Metropolitan Area
Networks Media Independent Handover Services, the entire contents
of which document is incorporated herein into and as part of this
patent application. Other IEEE, or other such standards on
protocols can be relied on as appropriate or desirable.
[0081] FIG. 3 is an exemplary diagram of a server 210 in an
implementation consistent with the principles of the disclosure to
achieve the desired technical effect and transformation. Server 210
may include a bus 240, a processor 202, a local memory 244, one or
more optional input units 246, one or more optional output units
248, a communication interface 232, and a memory interface 222. Bus
240 may include one or more conductors that permit communication
among the components of chunk server 250.
[0082] Processor 202 may include any type of conventional processor
or microprocessor that interprets and executes instructions. Local
memory 244 may include a random access memory (RAM) or another type
of dynamic storage device that stores information and instructions
for execution by processor 202 and/or a read only memory (ROM) or
another type of static storage device that stores static
information and instructions for use by processor 202.
[0083] Input unit 246 may include one or more conventional
mechanisms that permit an operator to input information to a server
110, such as a keyboard 118, a mouse 120 (shown in FIG. 2), a pen,
voice recognition and/or biometric mechanisms, etc. Output unit 248
may include one or more conventional mechanisms that output
information to the operator, such as a display 134, a printer 130
(shown in FIG. 2), a speaker, etc. Communication interface 232 may
include any transceiver-like mechanism that enables chunk server
250 to communicate with other devices and/or systems. For example,
communication interface 232 may include mechanisms for
communicating with master and clients.
[0084] Memory interface 222 may include a memory controller 122.
Memory interface 222 may connect to one or more memory devices,
such as one or more local disks 274, and control the reading and
writing of chunk data to/from local disks 276. Memory interface 222
may access chunk data using a chunk handle and a byte range within
that chunk.
[0085] FIG. 4 is an exemplary diagram of a master system 376
suitable for use in an implementation consistent with the
principles of the disclosure to achieve the desired technical
effect and transformation. Master system 376 may include a bus 340,
a processor 302, a main memory 344, a ROM 326, a storage device
378, one or more input devices 346, one or more output devices 348,
and a communication interface 332. Bus 340 may include one or more
conductors that permit communication among the components of master
system 374.
[0086] Processor 302 may include any type of conventional processor
or microprocessor that interprets and executes instructions. Main
memory 344 may include a RAM or another type of dynamic storage
device that stores information and instructions for execution by
processor 302. ROM 326 may include a conventional ROM device or
another type of static storage device that stores static
information and instructions for use by processor 302. Storage
device 378 may include a magnetic and/or optical recording medium
and its corresponding drive. For example, storage device 378 may
include one or more local disks that provide persistent
storage.
[0087] Input devices 346 used to achieve the desired technical
effect and transformation may include one or more conventional
mechanisms that permit an operator to input information to the
master system 374, such as a keyboard 118, a mouse 120, (shown in
FIG. 2) a pen, voice recognition and/or biometric mechanisms, etc.
Output devices 348 may include one or more conventional mechanisms
that output information to the operator, including a display 108, a
printer 142 (shown in FIG. 1), a speaker, etc. Communication
interface 332 may include any transceiver-like mechanism that
enables master system 374 to communicate with other devices and/or
systems. For example, communication interface 332 may include
mechanisms for communicating with servers and clients as shown
above.
[0088] Master system 376 used to achieve the desired technical
effect and transformation may maintain file system metadata within
one or more computer readable mediums, such as main memory 344
and/or storage device.
[0089] The computer implemented system provides a storage and
delivery base which allows users to exchange services and
information openly on the Internet used to achieve the desired
technical effect and transformation. A user will be enabled to
operate as both a consumer and producer of any and all digital
content or information through one or more master system
servers.
[0090] A user executes a browser to view digital content items and
can connect to the front end server via a network, which is
typically the Internet, but can also be any network, including but
not limited to any combination of a LAN, a MAN, a WAN, a mobile,
wired or wireless network, a private network, or a virtual private
network. As will be understood, a very large numbers (e.g.,
millions) of users are supported and can be in communication with
the website at any time. The user may include a variety of
different computing devices. Examples of user devices include, but
are not limited to, personal computers, digital assistants,
personal digital assistants, cellular phones, mobile phones, smart
phones or laptop computers.
[0091] The browser can include any application that allows users to
access web pages on the World Wide Web. Suitable applications
include, but are not limited to, Microsoft Internet Explorer.RTM.,
Netscape Navigator.RTM., Mozilla.RTM. Firefox, Apple.RTM. Safari or
any application adapted to allow access to web pages on the World
Wide Web. The browser can also include a video player (e.g.,
Flash.TM. from Adobe Systems, Inc.), or any other player adapted
for the video file formats used in the video hosting website.
Alternatively, videos can be accessed by a standalone program
separate from the browser. A user can access a video from the
website by, for example, browsing a catalog of digital content,
conducting searches on keywords, reviewing aggregate lists from
other users or the system administrator (e.g., collections of
videos forming channels), or viewing digital content associated
with particular user groups (e.g., communities).
VI. Computer Network Environment
[0092] Computing system 100, described above, can be deployed as
part of a computer network used to achieve the desired technical
effect and transformation. In general, the above description for
computing environments applies to both server computers and client
computers deployed in a network environment. FIG. 5 illustrates an
exemplary illustrative networked computing environment 400, with a
server in communication with client computers via a communications
network 450. As shown in FIG. 5, server 410 may be interconnected
via a communications network 450 (which may be either of, or a
combination of a fixed-wire or wireless LAN, WAN, intranet,
extranet, peer-to-peer network, virtual private network, the
Internet, or other communications network) with a number of client
computing environments such as tablet personal computer 402, mobile
telephone 404, telephone 406, personal computer 402, and personal
digital assistant 408. In a network environment in which the
communications network 450 is the Internet, for example, server 410
can be dedicated computing environment servers operable to process
and communicate data to and from client computing environments via
any of a number of known protocols, such as, hypertext transfer
protocol (HTTP), file transfer protocol (FTP), simple object access
protocol (SOAP), or wireless application protocol (WAP). Other
wireless protocols can be used without departing from the scope of
the disclosure, including, for example Wireless Markup Language
(WML), DoCoMo i-mode (used, for example, in Japan) and XHTML Basic.
Additionally, networked computing environment 400 can utilize
various data security protocols such as secured socket layer (SSL)
or pretty good privacy (PGP). Each client computing environment can
be equipped with operating system 438 operable to support one or
more computing applications, such as a web browser (not shown), or
other graphical user interface (not shown), or a mobile desktop
environment (not shown) to gain access to server computing
environment 400.
[0093] In operation, a user (not shown) may interact with a
computing application running on a client computing environment to
obtain desired data and/or computing applications. The data and/or
computing applications may be stored on server computing
environment 400 and communicated to cooperating users through
client computing environments over exemplary communications network
450. The computing applications, described in more detail below,
are used to achieve the desired technical effect and transformation
set forth. A participating user may request access to specific data
and applications housed in whole or in part on server computing
environment 400. These data may be communicated between client
computing environments and server computing environments for
processing and storage. Server computing environment 400 may host
computing applications, processes and applets for the generation,
authentication, encryption, and communication data and applications
and may cooperate with other server computing environments (not
shown), third party service providers (not shown), network attached
storage (NAS) and storage area networks (SAN) to realize
application/data transactions.
VII. Media Independent Information Service
[0094] The Media Independent Information Service (MIIS) provides a
framework and corresponding mechanisms by which an MIHF entity may
discover and obtain network information existing within a
geographical area to facilitate handovers. Additionally or
alternatively, neighboring network information discovered and
obtained by this framework and mechanisms can also be used in
conjunction with user and network operator policies for optimum
initial network selection and access (attachment), or network
re-selection in idle mode.
[0095] MIIS primarily provides a set of information elements (IEs),
the information structure and its representation, and a
query/response type of mechanism for information transfer. The
information can be present in some information server from which,
e.g., an MIHF in the Mobile Node (MN) can access it.
[0096] Depending on the type of mobility, support for different
types of information elements may be necessary for performing
handovers. MIIS provides the capability for obtaining information
about lower layers such as neighbor maps and other link layer
parameters, as well as information about available higher layer
services such as Internet connectivity.
[0097] MIIS provides a generic mechanism to allow a service
provider and a mobile user to exchange information on different
handover candidate access networks. The handover candidate
information can include different access technologies such as IEEE
802 networks, 3GPP networks and 3GPP2 networks. The MIIS also
allows this collective information to be accessed from any single
network. For example, by using an IEEE 802.11 access network, it
can be possible to get information not only about all other IEEE
802 based networks in a particular region but also about 3GPP and
3GPP2 networks. Similarly, using, e.g., a 3GPP2 interface, it can
be possible to get access to information about all IEEE 802 and
3GPP networks in a given region. This capability allows the MN to
use its currently active access network and inquire about other
available access networks in a geographical region. Thus, a MN is
freed from the burden of powering up each of its individual radios
and establishing network connectivity for the purpose of retrieving
heterogeneous network information. MIIS enables this functionality
across all available access networks by providing a uniform way to
retrieve heterogeneous network information in any geographical
area.
VIII. Software Programs Implementable in the Computing and Network
Environments to Achieve a Desired Technical Effect or
Transformation
[0098] A. Clinical Data Reporting Software Interface
[0099] A clinical data reporting software interface comprises a
communications network, communication medium, input and output
devices, computing application and software application that
communicate and compute data through a process of initialization by
user, interpretation of results, and comparison with aggregated
data.
[0100] The clinical data reporting software interface integrates
user preferences for procedures of interest along with associated
risk factors and risk mitigation factors to facilitate
interpretation of patient specific results for specific kinematic
dysfunctions, at each spine level. A user profile is also created
during the initialization step and generally does not change from
patient-to-patient for a particular user, however this profile is
changeable by the user.
[0101] FIG. 6 is a simplified block diagram of an initialization
process for the clinical data reporting software interface which is
performed once by the user, and can be updated as needed. In this
step the user defines a list of one or more procedures of interest
610, e.g., Procedure 1 612, Procedure 2 614 through Procedure N
616. These procedures can represent a range of potential surgeries
that a given user commonly prescribes to his or her patients. Once
the list of procedures of interest for a given user is defined,
then associated alerts 620 are also defined for each procedures
based on one or more kinematic risk factors and one or more
kinematic risk mitigation factors associated with each procedure.
For example, the user would define one or more kinematic risk
factors 622, 624, 626 corresponding to each of the procedures 612,
614, 616 as well as one or more kinematic risk mitigation factors
623, 625, 627 corresponding to each of the procedures. In some
aspects, a particular procedure may have no mitigation factors and
no risk factors, one or more mitigation factors and no risk
factors, no mitigation factors and one or more risk factors, or one
or more mitigation factors and one or more risk factors. For
purposes of illustration, FIG. 7e provides examples of kinematic
risk factors and kinematic risk mitigation factors for some
commonly prescribed spine surgeries.
[0102] The process of analyzing and interpreting results within the
clinical data reporting software interface is performed each time a
subject (patient) undergoes kinematic testing. The results for each
subject tested indicates one or more specific kinematic
dysfunctions that have been detected. In the context of the spine,
the one or more dysfunctions can be provided at each spine level.
The combination of risk and risk mitigation factors are defined as
specific alerts in the reporting system that can be presented to
the user (surgeon) for evaluation of changes to a planned procedure
for a particular patient.
[0103] FIG. 7a is a block diagram illustrating the process of
interpreting results within the clinical data reporting software
interface. For example, the measurement system 719 communicates
kinematic testing results for each patient 720. The kinematic
testing results can be, for example, an identification of specific
kinematic dysfunctions that have been detected at each spine level.
Based on the kinetic testing results 720 a list of alerts for each
procedure being considered is generated 726 which takes into
consideration the user (physician) profile created during the
initialization process 722 and a list of specific procedures being
considered for the particular patient 730. The alerts are presented
to the clinician 728 at which point the clinician can change the
threshold limits for detecting kinematic dysfunctions for that
patient 724, or change a list of procedures being considered 732.
Results of this process are presented to the user via the results
viewer 721.
[0104] FIGS. 7b and 7c show a first and second page of a two-page
sample form that represents one embodiment of data a user (e.g.,
surgeon) would provide during the initialization process, the data
from which would be part of the user profile described above with
respect to FIG. 6.
[0105] FIG. 7d is a screen shot 730 which illustrates how the
alerts that are configured during the initialization process can be
changed by the user using the clinical data reporting interface. In
this figure, the user can construct alerts using drop down menus
and check boxes, view existing alerts, assign priority to alerts,
edit alerts, delete alerts, and specify the exact configuration of
the alerts with respect to which bending mode the alert is based
on. Any changes made would then be saved in the user profile.
[0106] FIG. 7e shows the types of alerts that, according to one
embodiment, a spine surgeon may want to be warned about, both in
terms of "Good" and "Bad" risk mitigation factors alerts based on
the user profile set-up during the initiation process.
[0107] Additionally, users can view kinematic testing results via
the results viewer. Moreover, the results viewer allows for
multiple types of results viewing, including the viewing of moving
video images along with templates, graph, and numeric data, as
depicted in the screen shot 740 presented as FIG. 7f. As
illustrated in FIG. 7f, moving medical images can be played as an
image sequence, and displayed alongside graph data depicting the
relative motion between anatomical landmarks across a set of moving
images, wherein a cursor (a vertical line in this case) moves
across the graphs showing the point on each graph that corresponds
to the specific image frame being presented. Template data, showing
the measured position of each tracked landmark on the moving image
sequences, is also displayed by being overlaid on top of each
individual frame of the moving image sequences, such that the user
can confirm that the templates are placed appropriately on the
anatomical landmarks about which relative motion data is being
presented. Additional quantitative data is presented alongside the
graphs and image sequences. Different data from different bending
modes can be accessed via this capability, and the user is provided
with tools to let them determine which data to view.
[0108] The results viewer also enables a user to interact with
quantitative data regarding the detection of specific kinematic
dysfunctions. FIG. 7g shows a screen shot 750 representing an
example of this capability. In this figure, the results viewer
affords the user several analytic capabilities, such as the ability
to vary the statistical threshold limits with which abnormalities
are detected. For example, if a "False positive rate" is set to 5%,
only patients below 2.5.sup.th percentile or above 97.5.sup.th
percentile (relative to a normative dataset collected from
asymptomatic subjects) would be considered abnormal. If this "false
positive rate" were to be changed to 10%, the threshold limits
would then change to below the 5.sup.th percentile or above the
95.sup.th percentile, and so on. Another capability is to present
graphic icons which represent specific kinematic abnormalities,
then either presenting these icons or not depending on whether the
abnormality is detected based on the specific threshold limit set
by the user. Another capability is to view measurement data
graphically and numerically. Different data from different bending
modes can be accessed via this capability, and the user is provided
with tools to let them determine which data to view.
[0109] As shown in FIG. 7G alerts can be presented to the user as a
graphic presentation. An embodiment of this capability is
represented in the screen shot 760. As described above, the
statistical threshold limits with which abnormalities are detected
can be varied by the user, and the resulting changes to the list of
surgical alerts which are triggered are presented to the user in
real time.
[0110] The clinical data reporting software system provides a
process of creating a centralized aggregate database allowing for
data input, viewing and querying that can be used by the user to
compare potential clinical outcomes of the subjects.
[0111] FIG. 8a is a simplified block diagram outlining the process
and mechanism for inputting additional data on each subject to
include, such data to include: demographic, height/weight/other
physical measurements, subject history, symptoms, neurological exam
results, other co-morbidities at each level, other systemic patient
co-morbidities (such as diabetes, for example), prior procedures
performed and their related outcome(s), as well as other
parameters, and a process for transmitting this additional data to
an aggregated database. The system provides a process for
collecting data from all subjects tested, creating an aggregated
database that can be used for consideration and comparison of
outcomes for subjects matched based on: 1) kinematic presentation,
2) additional data collected, and 3) procedure being considered.
The predicted outcome data is presented to the user and can be used
to modify inputs to start the process over again with a new series
of inputs if desired.
[0112] For patients who get tested, there is an additional process
that allows the user (surgeon/clinician) to input additional data,
then view data regarding potential clinical outcomes of procedures
being considered by querying the aggregated database. Kinematic
testing results for each patient, which indicates the specific
kinematic dysfunction that has been detected, for example, at each
spine level 820 communicates with a query aggregated database 840
to determine outcomes for patients matched based on kinematic
presentation, additional data collected on the patient, and the
procedure being considered. The user can change the list of
procedures being considered 832 which changes the list of specific
procedures being considered for a specific patient 830 which in
turn impacts the list of alerts generated for each procedure being
considered 826. The list of alerts 826 also factors in the user
profile from the initialization process 822. When alerts are
presented to the user 828 it is possible for the clinician to
change threshold limits for detecting kinematic dysfunctions 824,
which can impact the query aggregated database 840. Additional data
may also be collected from the patient 834 which can then be
transmitted to the centralized database 838 and presented to the
user 836.
[0113] FIG. 8b is a screen shot 850 that illustrates a process of
creating a centralized aggregate database via data input, viewing
and querying that can be used by the user to compare potential
clinical outcomes of the subject. During the process step, the user
changes to a list of procedures being considered which is depicted
as being accomplishable by checking boxes and drop down menus of
procedures being considered at each spine level. The process step
process and mechanism for inputting additional data on each subject
is depicted as being accomplishable by checking various boxes and
drop down menus listed on the form. The process step present
outcomes data to user is depicted as being accomplishable via a
series of drop down menus and check boxes which allow the user to
specify which outcome measurement is being assessed (pain relief at
2 years, for example), and the output data are presented in terms
of a percentage that had good pain relief. In FIG. 8c a screen shot
860 for inputting neurological exam results into the aggregated
database is shown. FIG. 8d a screen shot 870 for inputting a
patient's pain scores into the Aggregated Database, as well as a
process and mechanism to select among various outcomes assessments
to be output, are shown.
[0114] As an example, the clinical data reporting software system
interprets kinematic results of subjects that were tested in a
standing (active) or lying down (passive) position, which allows
for isolating the muscle or load contribution, generating and/or
interfacing with a computer model of biomechanics specific to a
given subject. These computer models of biomechanics usually
include anatomical and functional models, and by inputting patient
specific data along with measurements of how kinematics were
different between loaded active and unloaded passive bending, it
can be possible to produce explanatory hypotheses that can explain
the observed kinematics based on the anatomical and functional
models.
[0115] FIG. 9 is a block diagram outlining the process of isolating
the cause of any observed dysfunction to either loads or muscles by
use of a computer model of spine biomechanics 942, such as a finite
element analysis or a model simulating soft tissue dynamics (such
as the ANYBODY MODELING SYSTEM.TM., manufactured by Anybody
Technologies, Aalborg, Denmark), combined with kinematic test data
collected from subjects in a standing and lying down position 920,
which can influence the clinical treatment decision of the user by
providing data customizable to each patient as to how the patients
muscles are functioning.
[0116] One skilled in the art will appreciate that only one
embodiment of the patient data recording software interface is
represented in the above description, and there are many other
alternative embodiments of different joints other than the spine,
different mammalian animals other than humans, different
embodiments and designs other than those presented to accomplish
the essential function described herein.
[0117] B. Surgical Navigation and Patient Positioning
[0118] Systems and methods are also contemplated for registering,
for example, spinal motion data to an instrument-supported
therapeutic procedure, such when using surgical planning,
assistance and/or surgical navigation systems. The systems and
methods use the platform disclosed in FIGS. 1-5 above in
combination with surgical planning, assistance and/or navigation
systems as well as with patient positioning systems. Additionally,
the systems and methods can be configured to communicate with
surgical planning, assistance, and/or navigation devices and system
as well as with patient positioning systems. Surgical navigation
systems include, for example, robotic surgical instrument systems.
Suitable systems include, for example, a plurality of articulating
arms having at least two articulation joints, where the
articulating arms are adapted to be inserted into an operative
space in a substantially straight configuration and further adapted
to controllably articulate inside the operative space, with at
least three degrees of freedom of movement; at least one access
port adapted to receive the articulating arms; and a controller
adapted to control the articulation of the articulating arms inside
the operative space to perform a surgical procedure. See, for
example, U.S. Patent Pub. 2011/0238080 by Ranjit et al. published
Sep. 29, 2011, entitled Robotic Surgical Instrument System; U.S.
Pat. Nos. 7,996,110 by Lipow et al. issued Aug. 9, 2011, for
Surgical Robot and Robotic Controller; 7,865,269 by Prisco et al.
issued Jan. 4, 2011, for Robotic Surgical System and Joint Motion
Controller Adapted to Reduce Instrument Tip Vibrations; and
6,228,089 to Wahrburg issued May 8, 2011, for Device for
Positioning and Guiding a Surgical Instrument During Orthopedic
Interventions.
[0119] The therapeutic procedure can comprise of instrumentation
that facilitates a pre-determined therapeutic outcome. For example,
spinal motion and intra-vertebral articulation can be determined by
a kinematic measuring system. The motion data can then be
transferred and registered to an automated or mechanical device.
Suitable instruments include a surgical navigation system, which is
automated or manually operated, or combinations thereof. Surgical
navigation systems include, for example, StealthStation.RTM.
iNAV.TM. or iOR.TM. or Treon.TM. or TRIA.TM., available from
Medtronic or PiGalileo.TM. Computer-Assisted Orthopedic Surgery
System available from Plus Orthopedics. Moreover, the therapeutic
procedure may or may not include surgical implants, such as where a
therapy is targeted at matching pre-determined outcome to therapy.
Inter-vertebral motion data can also be acquired manually or via an
automated system. The system can also be adapted and configured to
acquire both static and dynamic parameters. As will be appreciated
by those skilled in the art, data to be transferred can be manually
or automatically transferred. An optimal position and orientation
outcome of the spine can also be determined by the system and
transferred within the system or to another system or user. In at
least some embodiments, the such surgical navigation system
operates such that it can maintain orientation and position in up
to 6 degrees of freedom: moving up and down (heaving); moving left
and right (swaying); moving forward and backward (surging); tilting
forward and backward (pitching); turning left and right (yawing);
and tilting side to side (rolling).
[0120] A variety of implants, such as spinal implants, can be used
with the system, including devices that fuse the spine or
facilitate motion preservation. Such implants can have
pre-determined optimal specifications for position and
orientation
[0121] FIG. 10 is a simplified block diagram showing system
components and inter-connections of an embodiment of the present
disclosure that involves the integration of a clinical data
reporting software component with a surgical navigation system. In
such an integral system there would be three classes of input
information. First, data can be recorded directly from the patient,
which could include such diagnostic data as 1020, kinematic data
collected from the subject as well as generating a computer model
of spine biomechanics 1042, such as one that has been programmed
with patient-specific parameters. Additionally, data could also
recorded directly from the surgeon or treating physician, such as
surgical scenario planning data 1044, surgical alerts generated
pre-operatively, and a list of specific procedures being considered
for the patient 1030. In additional aspects, data can be collected
from sources external to the subject and the physician/surgeon,
such as queries of previously-collected clinical databases 1046
such as normative data and pre- to post-surgical functional and
pain data as well as data regarding the properties of specific
implant devices 1048, such as geometric and functional data. All of
these input datasets feed data into a surgical navigation system
1050, such as those that are currently commercially available such
as NAVIGATION SYSTEM II (Stryker Instruments, Dallas, Tex.) and
STEALTHSTATION S7 (Medtronic Navigation, Louisville, Colo.) or any
of the other surgical navigation systems mentioned previously in
this section. Surgical navigation systems can also include
neuro-monitoring systems such as the NVJJB/M5 system (Nuvasive, San
Diego, Calif.). Having this input data available for use for a
surgical navigation system is extremely advantageous, because it
enables several novel and inventive new capabilities. For example,
surgical implant device placement and/or surgical approach could be
informed by patient specific geometric or functional factors that
are currently not available. Data collected from previous clinical
studies could be applied during surgery through an iterative
navigational process accomplished by the surgical navigation system
1050 to optimize device placement and surgical approach with a
multitude of potential goals: (i) to achieve placement and/or
function as close to normative values as possible; (ii) to achieve
a specific type of functional outcome; (iii) achieve parameters
appropriate to a specific type of device design; (iv) to maximize
the chance of reducing pain; and (d) any combination of the above,
plus others.
[0122] The surgical navigation system 1050 may also then connect
with an operating table/patient positioner 1052. This operating
table/patient positioner 1052 is then able to communicate data to
and from the surgical navigation system (to: control data to
control to position of the patient and other data; from: data
regarding position of the patient, and other data), which in turn
is in communication with one or more of the various components
(e.g., computer model, kinematic testing results, specific
procedures being considered, surgical scenario planning, clinical
databases, data regarding specific contemplated implants, and/or
kinematic testing system). This operating table/patient positioner
1052 can then be used to put the patient into a specific posture
during a surgical operation based on parameters determined via the
surgical navigation system 1050 or any of the components with which
the surgical navigation system 1050 is in communication. A feedback
loop is also contemplated, wherein real time kinematic testing
system and other testing modalities to assess position and function
of anatomy and instrumentation can be collected from the patient
1053 and is communicated to the surgical navigation system 1050,
which can then utilize this data to adjust either parameters within
the surgical navigation system 1050, or parameters within the
operating table/patient positioner 1052. Such real time kinematic
testing systems 1054 could include imaging modalities, position
sensors, motion sensors, electromyography data collection devices,
and a host of other data collection devices. In an alternative
embodiment, the operating table/patient positioner 1052 can be
connected directly to the various components of the system (e.g.,
computer model, kinematic testing results, specific procedures
being considered, surgical scenario planning, clinical databases,
data regarding specific contemplated implants, and/or kinematic
testing system) without the use of a surgical navigation system
(for such a configuration, all of the connections going into the
surgical navigation system 1050 would instead connect directly to
the patient positioner 1052, thus bypassing the surgical navigation
system 1050).
[0123] FIG. 11 shows the center of rotation concept as it applies
to lumbar spine levels. Center of Rotation (COR) is a point (x, y)
on a plane (sagittal and transverse) that corresponds to the
"fulcrum region" of a vertebral level (i.e. where forces are
concentrated during motion). The present disclosure could use COR
measurements for each patient in loaded active (i.e.
muscle-involved) bending and unloaded passive (i.e. no muscles
involved) bending. Coronal and sagittal plane COR measurements
could be taken, transverse plane COR can also be derived from
these. Normative measurements (i.e. what is "normal"), based on
clinical trials conducted on asymptomatic subjects are represented
graphically. One way this is valuable to users is to know how COR
changes from standing to lying: surgeons operate on patients while
they are lying down, however their targets are usually based on
normal operating conditions (which are standing up). Therefore
knowing how a given parameter, such as COR, changes from standing
to lying can help the surgeon achieve a target standing COR based
only on the geometry and orientation of the anatomy in the lying
posture.
[0124] FIG. 12 is a table that describes, according to one
embodiment of the present disclosure, some ways in which functional
targets could be valuable in a surgical navigation system intended
for spine surgery. For example, the navigation target could be the
location and orientation of the superior and inferior endplates of
a fusion construct. In this case the biomechanical goal would be to
ensure that adjacent level CORs are as close to "normal" as
possible. The clinical benefit would therefore be to avoid abnormal
facet loading (if COR is too anterior), off-loading (if too
posterior), and left/right imbalances. In another example, the
navigation target would be the placement of inter-body and motion
preserving devices on vertebral endplate. In this case the
biomechanical goal would be to ensure device overlaps with COR of
the joint, aligning forces through the device and avoiding
problematic moment arms. The clinical benefit would include: (1) to
take advantage of Wolf's law to optimize bone in-growth, and/or (2)
to reduce stressing moment arms to avoid failure of construct.
[0125] FIG. 13 shows step one of a hypothetical example two step
process in which functional targeting could be utilized in a spine
surgical navigation system. In this figure, a sagittal plane
routine is described wherein the desired position and location of
endplates is achieved via device sizing and placement distraction
or compression along posterior rods. By varying the geometry of the
fusion construct, the COR at adjacent levels can be affected such
that they are moved into an orientation that is deemed to be more
optimal by the surgeon, based on for example the location that is
observed in asymptomatic subjects. A similar routine could be done
for coronal pane. This demonstrates an example workflow for a
fusion construct; similar workflows could be accomplished for other
spine surgical constructs (motion preserving, interspinous devices,
etc) as well as for other joints.
[0126] FIG. 14 shows step two of a hypothetical example two step
process in which functional targeting could be utilized in a spine
surgical navigation system. According to this figure, Step two of
the two step process is to modify the fusion construct as necessary
to ensure coverage by an interbody device of the fulcrum region of
the fused level. This is accomplished via several sub-steps: (a)
project new "connector lines" between the "new" locations of the
COR of the adjacent levels; (b) Determine the region on superior
endplate of the inferior vertebra of the index level (L5 in this
case) endplate where "new" COR connector lines intersect (marked
"x"); (c) this is the "fulcrum region" that needs to be "covered"
by the interbody device; (d) Adjust interbody construct to ensure
"coverage" of the "fulcrum region"; (e) This is shown for coronal
plane; a similar routine is also done for the sagittal plane.
Although FIGS. 13 and 14 contemplate this process applied to a
fusion surgery, one skilled in the art would appreciate that there
are multiple other embodiments which could be directed to: optimize
the fusion construct geometry based on different parameters than
COR, optimize the fusion construct based on other uses of COR,
optimize other types of surgical constructs associated with other
types of surgeries for COR and other parameters.
[0127] The inputs, information and reports can be transmitted
through either a direct wire-based electronic connection between
the two or more components, or through a wireless connection, and
can be of the type that is derived from computer programming or
from operator, user or subject input, or from a combination of
computer programmed information plus operator, user and/or subject
input.
[0128] C. Imaging System Moveable within a Vertical Plane
[0129] The imaging system moveable within a vertical plane is an
apparatus providing input image data for the measurement system
that assists with imaging during joint operation. It consists of a
medical imaging system mounted to a free floating, ballasted
vertical plane, so that the medical imaging system can be moved in
tandem with the motion of the joint to keep joint anatomy within a
field of view (for example keeping a knee in a field of view as a
live human testing subject is walking). It can be operated in a
manual or automatic mode, as further described below.
[0130] FIG. 15 is a block diagram of an imaging system moveable
within a vertical plane, operating in manual mode. The imaging
system image collection device 1500 could be an image intensifier,
a flat panel detector, or any number of other medical diagnostic
image collection devices. The imaging system image collection
device 1500 is free to move within a vertical plane, via movable
connectors to a frame assembly 1512 and base that rests upon the
floor. Ballast system 1510 and frame assembly base 1512 are
connectable via a movable connector, such as linear bearings, that
allow for the motion of the imaging system image collection device
1500 motion within a vertical plane. The ballast system 1510 can be
rigidly connected to the frame assembly and base 1512, and movably
connected to the imaging system image collection device 1500 such
that the weight of the imaging system image collection device 1500
is fully ballasted. With the ballast system 1510 engaged, the only
forces required to move the imaging system image collection device
1500 within the vertical plane are those required to overcome the
devices inertia. The target joint anatomy 1502 for a particular
procedure, a knee for example, is then connected to the imaging
system image collection device 1500, such that the entire joint
region of interest can remain in the field of view for the imaging
of the joint during operation. The joint can be connected in such a
manner as to reduce extraneous movement outside a desired target
range of motion.
[0131] FIG. 16 is a block diagram of the imaging system moveable
within a vertical plane, operating in automatic mode. In automatic
mode, the descriptions of the components and the connections
between them are no different than for manual mode, for components
imaging system image collection device 1600, ballast system 1610,
and frame assembly and base 1612. In manual mode, it is the motion
of the joint, as transmitted via a connection such as a rod, that
provides the forces to move the imaging system image collection
device 1600. However, in automatic mode this is accomplished via an
actuator 1608 that is connected to an automatic control system
1606. The automatic control system or actuator control system 1606
receives signals coming from the position/motion sensor 1604, which
in turn is connected to a target joint anatomy 1602, such that the
position/motion sensor 1604 senses the motion of the target joint
anatomy. The automatic control system 1606 is then able to process
this input data and produce control signals cause an actuation of
the actuator 1608 to move the imaging system image collection
device 1600. Overall, the motion of the imaging system image
collection device 1600 should track the motion of the target joint
anatomy such that the entire joint region of interest can remain in
the field of view even as the joint anatomy 1602 moves relative to
the frame assembly and base 1612. The actuator 1608 connects to the
imaging system image collection device 1600 such that it can affect
its motion within a vertical plane. The actuator 1608 is connected
or connectable to the actuator control system 1606 and the
position/motion sensor 1604, via a connection sufficient for
transmitting control signals and position/motion data, such as a
wired or wireless connection. The actuator control system 1606 is
an electronic control system, such as a programmable logic
controller or a laptop computer, that is capable of processing
position and motion signals coming from both the position/motion
sensor 1604 as well as from the actuator 1608, and of producing
actuator control signals to affect a motion as described
herein.
[0132] The image data can be transmitted through either a direct
wire-based electronic connection between the two or more
components, or through a wireless connection, and can be of the
type that is derived from computer programming or from operator,
user or subject input, or from a combination of computer programmed
information plus operator, user and/or subject input. One skilled
in the art will appreciate that there are many shapes, sizes, and
configurations of the imaging system moveable within a vertical
plane required for various mammalian joints.
[0133] A collimator device 1713 may be optionally attached to
either or both of the attachment arms 1701 and/or 1705 for use in
the case of ionizing radiation based imaging modalities. This
collimator device is intended to block the path of ionizing
radiation for one or both of two purposes: (1) minimize the dose of
absorbed radiation on the part of the patient, and (2) minimize
"flare", which can degrade the contrast of medical images and can
occur when X-rays pass unimpeded from the source to the detector
without first passing through the patient. This collimator device
is composed of a leaded material or some other material with
sufficient density as to partially or completely block ionizing
radiation from passing through it. Stationary collimator devices
that do not adjust during imaging are not useful, as the field of
interest within the imaging frame changes as the joint of interest
is in operation during testing. Therefore the collimator device
1713 is intended to maintain a changing field of interest within
the imaging frame as the position of the patient's anatomy changes
as a function of normal joint operation, such that "flare" and
radiation dose to the patient are both minimized while not
obscuring any of the physiologic structures of interest. In one
embodiment, the collimator connects to both attachment arms 1701
and 1705 according to FIGS. 17A-B so that only specific band around
each attachment arm is imaged. For situations in which it is
feasible, it is ideal to place the collimator between the patient
and the radiation source so as to block radiation that would have
imaged parts of the patient's anatomy that are not of interest for
the prescribed diagnostic study. The collimator device 1713 may
also incorporate an actuator that is intended to change the
position and geometry of the shielding pieces dynamically during
the tested motion. This actuator can be controlled by an electronic
control system that incorporates stored input data or real time
input data, both data coming from other parts of the motion control
device or from another device such as an imaging device or a
posture assistance device. The purpose of this functionality of the
collimator device is to capable of dynamically adjusting the
geometry of the shield during tested motion so as to maximize the
benefit of the collimator device in terms of reducing radiation
dose to the patient or in terms of reducing "flare", or both.
[0134] The apparatus can further be adapted and configured to keep
a specific part of the patient's anatomy within the imaging field
of interest during imaging. This can be accomplished by an imaging
field adjustment mechanism capable of calculating the positional
adjustments necessary to keep the joint of interest within and/or
centered within the imaging field, then producing a movement
between the support frame base 1717 and the support frame vertical
member 1715, such that the specific part of the patient's anatomy
is held within and/or centered within the field of imaging. In one
embodiment, this imaging field adjustment mechanism would function
as follows: (1) while attached to the apparatus, the patient is
moved to extreme position #1 of the motion sweep that is being
studied; (2) the apparatus is positioned relative to the medical
diagnostic device such that the anatomy of interest on the patient
is centered in the field of image of the diagnostic device; (3)
this relative position between the imaging device and the apparatus
is recorded as extreme position #1; (4) the patient is then moved
to extreme position #2 of the motion sweep that is being studied;
(5) this relative position between the imaging device and the
apparatus is recorded as extreme position #2. Once these two
extreme relative positions between the apparatus and medical
diagnostic device have been recorded, the imaging field adjustment
mechanism then affects a relative motion between the support frame
base 1717 and the support frame vertical member 1715 from extreme
position #1 to extreme position #2, and possibly back again, in
such a way that this relative motion is synchronized with the
motion sweep of the apparatus to hold a specific part of the
patient's anatomy within and/or centered within the imaging field
of interest. Furthermore, the calculation of motion between the
support frame base 1717 and the support frame vertical member 1715
required to keep the anatomy of interest within the imaging field
can be recorded and integrated into the computation of the range of
motion of the specific joint of interest. In an alternative
embodiment of the imaging field adjustment mechanism, an image
centering marker is placed on the patient that denotes where the
center of the imaging field should be positioned. The image
centering marker interacts with the medical diagnostic device in
such a way that the center of the imaging field always remains
fixed on the image centering marker. So as to not interfere with
the anatomy of interest, the image centering marker does not have
to be in the actual center of the imaging field, but instead in a
position within the image that remains relatively fixed throughout
the motion. Data encoding devices can be optionally attached to
either of the attachment arms 1701 and 1705 and/or the patient and
data to be transmitted directly to the medical images or other
diagnostic formats. During operation of the device, there are
several sets of data that can be generated by the operation of the
motion control device or by the operation of other devices used
during testing, such as the attachment mechanisms 1703 and 1707, or
the medical diagnostic device. Such data could include: time
synchronization data which is data indicating the exact point in
time when the motion device begins and ends a tested motion
sequence or a surgical step; the position of each or both of the
attachment arms 1701 and 1705, which could be a goniometer
measurement, a protractor measurement, or a measurement of the
displacement of each attachment arms 1701 and 1705 relative to the
starting position or relative to the attachment mechanisms 1703 and
1707; parameters associated with the actuators, such as the level
of applied force, displacement, velocity, or other parameters; the
weight applied to the attachment arms 1701 and 1705 by the patient
at any given moment; the force applied by the subject on the
attachment arms 1701 and 1705 at any given moment; the
displacement, velocity, or other parameters associated with the
imaging field adjustment mechanism, or any other measurement
parameter that is relevant to the tested motion and that can be
generated by, for example, sensors included within the motion
control device or by an input from a data source external to the
motion control device, such as the medical diagnostic device. The
data encoding device may either be mechanical or digital devices
that are capable of producing discernable analog or digital
markings within the field of imaging that therefore get captured on
the medical images resulting from the operation of the present
disclosure (when the medical diagnostic device is a medical imaging
device) that: (1) do not interfere with part of the field of
imaging of interest for the prescribed diagnostic study, (2) can
transmit data via the image that can be decoded at a later point in
time such that all encoded data can be derived entirely through an
analysis of each medical image. In one embodiment of the present
disclosure using X-ray based fluoroscopy imaging, the data encoding
device can be a radio-opaque protractor showing the angular
displacement of the attachment arms 1701 and 1705, or alternatively
could be a radio-opaque analogue needle-gauge to measure the
current through the actuator at any point in time.
[0135] Different orientations of the diagnostic imaging system: The
present disclosure contemplates a mechanism adapted and configured
to perform diagnostic imaging of a joint where the field of imaging
is fixed in space; however a diagnostic imaging system that does
not have a field of imaging that is fixed in space could also be
utilized. In such a case, the diagnostic imaging equipment would be
operably moveable so that the field of imaging does not stay fixed
in space, but instead would stay fixed with respect to: (1) the
motion platform, (2) a landmark on the subject, or (3) any
trajectory defined by the operator.
[0136] While preferred embodiments of the present disclosure 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.
* * * * *