U.S. patent application number 15/215919 was filed with the patent office on 2017-01-26 for dynamic reference frame for surgical navigation system.
The applicant listed for this patent is IZI MEDICAL PRODUCTS, LLC. Invention is credited to GREGORY C. GROENKE, NELSON L. HULDIN, HOLGER-CLAUS ROSSNER.
Application Number | 20170020622 15/215919 |
Document ID | / |
Family ID | 57836431 |
Filed Date | 2017-01-26 |
United States Patent
Application |
20170020622 |
Kind Code |
A1 |
HULDIN; NELSON L. ; et
al. |
January 26, 2017 |
DYNAMIC REFERENCE FRAME FOR SURGICAL NAVIGATION SYSTEM
Abstract
A device and manufacturing method for a surgical navigation
system, comprising a rigid frame member having a top portion, a
plurality of mounts each having a top surface, wherein the
plurality of mounts are disposed at prescribed locations of the top
portion. The top surface of the plurality of mounts are configured
to align on a common horizontal plane that extends in parallel with
the top portion of the frame member.
Inventors: |
HULDIN; NELSON L.; (OWINGS
MILLS, MD) ; GROENKE; GREGORY C.; (OWINGS MILLS,
MD) ; ROSSNER; HOLGER-CLAUS; (FELDKIRCHEN B.
MUENCHEN, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
IZI MEDICAL PRODUCTS, LLC |
OWINGS MILLS |
MD |
US |
|
|
Family ID: |
57836431 |
Appl. No.: |
15/215919 |
Filed: |
July 21, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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14807914 |
Jul 24, 2015 |
|
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15215919 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2034/2055 20160201;
A61B 2034/2068 20160201; A61B 34/20 20160201; A61B 2034/252
20160201; A61B 2017/00526 20130101; A61B 2090/3983 20160201; A61B
34/25 20160201; A61B 90/10 20160201; A61B 90/39 20160201; A61B
2090/3937 20160201; A61B 2017/00199 20130101; A61B 2017/0023
20130101; A61B 2034/207 20160201 |
International
Class: |
A61B 90/10 20060101
A61B090/10; A61B 34/20 20060101 A61B034/20 |
Claims
1. A device comprising: a rigid frame member having a top portion;
a plurality of mounts each having a top surface, wherein the
plurality of mounts are disposed at prescribed locations of the top
portion; and wherein the top surface of the plurality of mounts are
configured to align on a common horizontal plane that extends in
parallel with the top portion of the frame member.
2. The device of claim 1, wherein indicia for respective functional
icons are disposed on the top portion at respective prescribed
locations registered to respective image space locations in an
image space comprising radiological image data for a patient.
3. The device of claim 2, wherein a function is executed when the
indicia representing the function is touched.
4. The device of claim 1, wherein the mounts comprise mounting
posts.
5. The device of claim 4, wherein one or more tracking marker
elements are mounted to the mounting posts such that upon mounting,
a centerline of the one or more tracking marker elements align on
the common horizontal plane that extends in parallel with the top
portion of the frame member.
6. The device of claim 5, wherein the tracking marker elements are
spherical.
7. The device of claim 5, wherein the tracking marker elements are
light-reflecting spherical markers.
8. The device of claim 1, wherein the frame member comprises an
asymmetrical configuration.
9. The device of claim 8, wherein the asymmetrical configuration
comprises an astroid design rotated about a central normal axis of
the frame member.
10. The device of claim 9, wherein a rotation angle is between 22
and 23 degrees.
11. The device of claim 9, wherein an external contour of the
astroid design comprises concave (inwardly-curved) sides.
12. The device of claim 11, wherein the astroid design has four
concave (inwardly-curved) sides.
13. The device of claim 11, wherein the concave (inwardly-curved)
sides terminate at a cusp.
14. The device of claim 13, wherein the cusp comprises rounded
corners.
15. The device of claim 11, wherein the mounts are disposed at each
cusp.
16. The device of claim 1, wherein the device is disposable.
17. A method of manufacturing a device comprising: connecting a
plurality of mounts on a top surface of a frame member, wherein
each plurality of mounts has a top surface, wherein the top surface
of the plurality of mounts are configured to align on a common
horizontal plane that extends in parallel with the top surface of
the frame member; and mounting one or more tracking marker elements
on each mount and aligning a centerline of each tracking marker
element with the top surface.
18. The method of claim 17, comprising disposing indicia for
respective functional icons at respective prescribed physical
locations on the top surface of the frame member, wherein each
respective prescribed physical locations is registered to a
respective image space location corresponding to a respective
functional icon disposed on a display unit configured to display
patient radiological image data.
19. The method of claim 18, comprising executing a function
associated with a functional icon by touching the respective
indicia for the functional icon.
20. The method of claim 19, wherein executing the function
associated with the functional icon comprises invoking an
appropriate software routine.
21. The method of claim 17, wherein the frame member comprises an
asymmetric configuration.
22. The method of claim 21, wherein the asymmetric configuration
comprises an astroid design rotated about a central normal axis of
the frame member.
23. The method of claim 22, wherein a rotation angle is between 22
and 23 degrees.
24. The method of claim 22, wherein an external contour of the
astroid design comprises concave (inwardly-curved) sides.
25. The method of claim 24, wherein the astroid design has four
concave (inwardly-curved) sides.
26. The method of claim 24, wherein the concave (inwardly-curved)
sides terminate at a cusp.
27. The method of claim 26, wherein the cusp comprises rounded
corners.
28. The method of claim 26, wherein the mounts are disposed at each
cusp.
29. The method of claim 17, wherein mounting the one or more
tracking marker elements on each mount and aligning a centerline of
each tracking marker element with the top surface forms a
pre-attached marker assembly on the device.
Description
CROSS-REFERENCE OF APPLICATION
[0001] This application is a divisional application of U.S. patent
application Ser. No. 14/807,914, entitled "DYNAMIC REFERENCE FRAME
FOR SURGICAL NAVIGATION SYSTEM", filed on Jul. 24, 2015, which is
incorporated herein by reference in its entirety.
BACKGROUND
[0002] Field of the Invention
[0003] The present invention relates generally to surgical
navigation systems. More particularly, the present invention
relates to a referencing device for a surgical navigation
system.
[0004] Related Art
[0005] Surgical navigation systems are employed in a variety of
surgical applications, for example, in neurosurgery, oral,
maxillofacial and facial surgery, ear nose and throat (ENT) surgery
or also for limb implantation in orthopedic surgery. Based on
three-dimensional patient image data, which are obtained by means
of X-ray images, computer tomography (CT), magnetic resonance
tomography (MRT) and/or positron emission tomography (PET),
surgical navigation systems of this type enable the position of
medical instruments to be visualized in real-time in the patient
image data in order to thereby assist the surgeon during operable
procedures.
[0006] To this end, it may be necessary to record and monitor the
position and orientation of the patient or a specific body part on
which a surgical procedure is to be carried out--also referred to
as "tracking." Conventional referencing devices, employed within
such surgical navigation systems, for example, have been used
usually comprising reference frames to which marking elements such
as light-reflecting spherical markers are attached. The
light-reflecting spherical markers allow a stereo camera system of
the navigation system to record the precise position and
orientation of the referencing device.
[0007] It is, therefore, an object of the present invention to
overcome the deficiencies of the prior art to provide an improved
apparatus capable of providing increased range of motion in at
least multiple to an infinite amount of directions while more
easily achieving and maintaining a sterile operating environment.
It is a further goal of the present invention to provide a method
and apparatus that achieves and maintains a dependable fixed
position of the referencing device during operational procedures
that eliminates the need to recalibrate the system.
SUMMARY
[0008] The foregoing needs are met, to a great extent, by the
present invention, wherein in one aspect a device is provided that
in some embodiments comprises a rigid frame member having a top
portion, a plurality of mounts each having a top surface, wherein
the plurality of mounts are disposed at prescribed locations of the
top portion. The top surface of the plurality of mounts are
configured to align on a common horizontal plane that extends in
parallel with the top portion of the frame member.
[0009] In accordance with another embodiment of the present
invention, a method is provided that in some embodiments comprises
connecting a plurality of mounts on a top surface of a frame
member, wherein each plurality of mounts has a top surface. The top
surface of the plurality of mounts are configured to align on a
common horizontal plane that extends in parallel with the top
surface of the frame member. The method may also include mounting
one or more tracking marker elements on each mount and aligning a
centerline of each tracking marker element with the top
surface.
[0010] There has thus been outlined, rather broadly, certain
embodiments of the invention in order that the detailed description
of the invention herein may be better understood, and in order that
the present contribution to the art may be better appreciated.
There are, of course, additional embodiments of the invention that
will be described below and which will form the subject matter of
the claims appended hereto.
[0011] In this respect, before explaining at least one embodiment
of the invention in detail, it is to be understood that the
invention is not limited in its application to the details of
construction and to the arrangements of the components set forth in
the following description or illustrated in the drawings. The
invention is capable of embodiments in addition to those described
and of being practiced and carried out in various ways. Also, it is
to be understood that the phraseology and terminology employed
herein, as well as in the abstract, are for the purpose of
description and should not be regarded as limiting.
[0012] As such, those skilled in the art will appreciate that the
concept upon which this disclosure is based may readily be utilized
as a basis for the designing of other structures, methods and
systems for carrying out the several purposes of the present
invention. It is important, therefore, that the claims be regarded
as including such equivalent constructions insofar as they do not
depart from the spirit and scope of the present invention.
[0013] Still other aspects, features and advantages of the present
invention are readily apparent from the following detailed
description, simply by illustrating a number of exemplary
embodiments and implementations, including the best mode
contemplated for carrying out the present invention. The present
invention also is capable of other and different embodiments, and
its several details can be modified in various respects, all
without departing from the spirit and scope of the present
invention. Accordingly, the drawings and descriptions are to be
regarded as illustrative in nature, and not as restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The accompanying drawings, which are incorporated herein and
constitute part of this specification, illustrate exemplary
embodiments of the invention, and, together with the general
description given above and the detailed description given below,
serve to explain the features of the invention.
[0015] FIG. 1 illustrates a top view, front view and back view of a
disposable dynamic reference for surgical navigation system,
according to an embodiment of the present invention.
[0016] FIG. 2 illustrates a bottom view of the disposable dynamic
reference frame of FIG. 1 utilized for a surgical navigation
system, according to an embodiment of the present invention.
[0017] FIG. 3 illustrates a top view of the disposable dynamic
reference frame highlighting a set of indicia disposed on the top
surface of the device, according to one embodiment of the present
invention.
[0018] FIG. 4 illustrates a top view of the disposable dynamic
reference frame highlighting the relative placement of the
attachment portal and the mounting pin structure, according to an
embodiment of the present invention.
[0019] FIG. 5 is a perspective view of the disposable dynamic
reference frame, according to one embodiment of the present
invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Definitions
[0020] Where the definition of terms departs from the commonly used
meaning of the term, applicant intends to utilize the definitions
provided below, unless specifically indicated.
[0021] For the purposes of the present invention, directional terms
such as "top", "bottom", "upper", "lower", "above", "below",
"left", "right", "horizontal", "vertical", "upward", "downward",
etc., are merely used for convenience in describing the various
embodiments of the present invention.
[0022] For purposes of the present invention, the term "astroid"
refers to a geometric design of a hypocycloid with four concave
(inwardly-curved) sides which may include a variety of names,
including tetracuspid, cubocycloid, and paracycle.
[0023] For purposes of the present invention, the term "cusp"
refers to a point made by the intersection of two curved lines or
curved structures. In select disclosed embodiments, the point may
be rounded
[0024] For purposes of the present invention, the term "disposable"
refers intended to be used once, or until no longer useful, and
then discarded.
[0025] For purposes of the present invention, the term "trapezium"
refers to a geometric design of trapezoid with no parallel
sides.
[0026] For purposes of the present invention, the term "indicia"
refers distinctive marks, characteristic markers or
indications.
[0027] For purposes of the present invention, the term "patient
space" refers to the physical space within which a patience exists
or is immersed. The physical space can include any portion or the
entire patient or area surrounding the patient including navigation
space of all physical entities such as interventional or surgical
instruments or tracking makers that may interact with the patient.
Generally patient space includes that area which is part of the
navigable field in which an instrument or navigated portion can be
tracked.
[0028] For purposes of the present invention, the term
"registering" refers to a process for determining the geometric
relationship between an anatomic structure(s) of interest and a
3-dimensional (3D) computer image constructed, for example, from
the preoperative CT scan. By way of this registration, a correct,
spatial reference between the 3D image data and the position and
orientation of the body part of the patient, observed by means of
referencing device, can be produced.
[0029] For purposes of the present invention, the term "surgical
navigation" refers to computer assisted surgery (CAS) representing
a surgical concept and set of methods that use computer technology
for pre-surgical planning and for guiding or performing surgical
interventions. CAS is also known as computer aided surgery,
computer assisted intervention, image guided surgery and surgical
navigation.
[0030] For purposes of the present invention, the term "surgical
navigation system" refers a system that allows visualization of an
operative site and surgical instruments simultaneously and relates
them to the patient's diagnostic images (e.g., computed tomographic
(CT) scans and magnetic resonance imaging (MRI)). A surgical
navigation system is used to guide the surgeon's movements during
an operation. It may display the real-time position of each
instrument and anatomical structure. These systems are used in
orthopedics, ENT, neurology and other surgical specialties.
Real-time observations occur via MRI, scanner, video camera or
another imaging process. Navigation data are incorporated into the
image to help the surgeon determine precise position within the
organism. Medical imaging is sometimes used to plan an operation
before surgery. Data integration enables the system to compare the
actual position of the target object with the ideal location
established during the planning phase. Such systems may be
mechanical, electromagnetic or optical. The most common are optical
devices, either passive or active. In the former, cameras locate
specific markers such as reflective targets, particular shapes or
colors. Active systems locate LEDs.
[0031] For purposes of the present invention, the term "touch" or
"touched" refers to action or condition of interacting with a
target using any appropriate means to include bodily appendage such
as fingers or any other part of the body or any other mechanical or
electrical tool or device.
[0032] For purposes of the present invention, the term
"x-direction" refers to the direction aligned with the x-axis of a
coordinate system.
[0033] For purposes of the present invention, the term
"y-direction" refers to the direction aligned with the y-axis of a
coordinate system.
[0034] For purposes of the present invention, the term
"z-direction" refers to the direction aligned with the z-axis of a
coordinate system.
DESCRIPTION
[0035] The invention will now be described with reference to the
drawing figures, in which like reference numerals refer to like
parts throughout. The following detailed description is of example
embodiments of the presently claimed invention with references to
the accompanying drawings. Such description is intended to be
illustrative and not limiting with respect to the scope of the
present invention. Such embodiments are described in sufficient
detail to enable one of ordinary skill in the art to practice the
subject invention, and it will be understood that other embodiments
may be practiced with some variations without departing from the
spirit or scope of the subject invention.
[0036] Conventional navigation systems and/or referencing devices
are known, for example, from documents DE 10 2011 054 730 A1, DE
698 33 881 T2, DE 10 2010 060 914 A1 or DE 60 2004 004 158 T2. WO
2006/012491 discloses marker elements together with a unit carrying
the marker elements--referred to as reference frames--as a single
disposable unit which can be produced by injection molding.
However, traditional navigation systems do not always allow for the
desired positioning and orientation of the referencing device, for
example, due to structural limitations in the design of its
arranged configuration and/or restrictions in movement such as
limited multiple ranges of motion and/or operating degrees of
freedom.
[0037] Another concern may include operating and maintaining a
sterile environment during surgical procedures. Medical devices,
such as referencing devices must also be sterile. Within such an
environment, marker elements may be removably attached, for
example, by means of a standardized clip attachment to pins
arranged on the referencing device. The referencing device may thus
be sterilized without marker elements and new, sterile, disposable
marker elements may be utilized for each use. Conventional
corresponding marker elements are known, for example, from document
DE 10 2009 019 986 A1.
[0038] In order to deduce the position and orientation of a patient
(or as the case may be, the body part of a patient on which a
surgical procedure is to take place), and in order to produce a
correct reference to the 3D image data, it is necessary to
calibrate the surgical navigation system by executing a
registration step. Various reference points are thereby
successively localized on the patient using a navigation apparatus
and correlated with corresponding points in the 3D image data.
[0039] The registration process determines the geometric
relationship between the anatomic structures of interest and the
3-dimensional (3D) computer image constructed, for example, from
the preoperative CT scan. Registration involves two steps. First,
the reference sensor is secured to a non-mobile structure. Then, a
registration tip, for example, is used sequentially to touch
pre-selected registration points (e.g., fiducial markers).
Registration points may be any anatomic structures that are
recognizable on the preoperative image (e.g. teeth, skin and bone).
Each time a registration point is touched with the registration
tip, the computer records the location of the position sensor and
the reference sensor. Using, for example, at least three
registration points, the computer calculates the physical position
of the anatomic structure with respect to the reference sensors.
The computer then uses this registration information to measure the
position of the pencil relative to the preoperative CT scan. The
patient's body part can be mobilized freely without the need to
re-initialize the registration process, because the reference
sensor is rigidly attached to the relevant structure of the
patient. By way of this registration, a correct, spatial reference
between the 3D image data and the position and orientation of the
body part of the patient can be produced.
[0040] In particular, in the case of surgical procedures involving
the brain, it is usually not possible to simply be limited to
reference points in the operating area for a necessarily precise
registration, but rather it is necessary, in the vast majority of
cases, to select a plurality of reference points at different
locations on the body of the patient. Since for this purpose
unhindered access to these locations on the body of the patient is
necessary, registration must thus take place before the patient can
be finally prepared for the actual surgical procedure and covered
in a sterile manner in the areas outside of the operating area.
[0041] As a practical matter, and as it pertains to the
registration device itself, following a successful registration
procedure necessarily means he registration device must be
considered as being potentially contaminated. Thus, appropriate
measures for protecting the patient must be taken before the
image-guided surgical procedure using the navigation system can
take place. As such, the reference frame is thus usually detached
from the fixation unit, sterilized, and provided with new sterile
marker elements and reconnected to the fixation unit. The fixation
unit as well as the interface between the fixation unit and the
reference frame must next be draped and/or otherwise covered. To
achieve this, holes are typically generated in medical drapes in
order to allow the reference frame or its components to protrude
therethrough and to subsequently attach to the fixation unit.
Additional care to secure and maintain medical drapes is also
provided in order to achieve a covering considered at least
sufficiently secure. From a user perspective, this approach is
presented as less than desirable since, on the one hand, the effort
is labor intensive and significant staff effort is required in
order to provide the necessary draping and covering for operational
procedure. And, on the other hand, the draping and covering is
often regarding as insufficiently secure for operating procedures.
This risks the sterility of the operating environment and loss of
time in addressing the same.
[0042] Accordingly, it is, therefore, an object of the present
invention to overcome the deficiencies of the prior art to provide
an improved apparatus capable of providing increased range of
motion in at least multiple to an infinite amount of directions
while more easily achieving and maintaining a sterile operating
environment. It is a further goal of the present invention to
provide a method and apparatus that achieves and maintains a
dependable fixed position of the referencing device during
operational procedures that eliminates the need to recalibrate the
system.
[0043] Embodiments of the present invention disclose the design and
use of a disposable, single-use medical device. Turning to device
representation 100 in FIG. 1, a disposable Dynamic Reference Frame
(DRF) 101 for use in a surgical navigation system is illustrated.
The dynamic reference frame comprises a track-able top portion 102
for positioning and mounting one or more tracking marker elements
106 onto one or more mounting posts 107, 108, 109 and 110 disposed,
for example, at four endpoints of the astroid design.
[0044] In the disclosed embodiment, DRF 101 has substantially an
asteroid design. One disclosed design includes an external contour
having an asymmetrical configuration that has been rotated by
approximately 1/8 of a turn about its central normal axis (a
rotation angle in the range of 22 degrees to 23 degrees) having,
for example, four concave (inwardly-curved) sides 111. Select
embodiments may include concave (inwardly-curved) sides 111
generally terminating with rounded corners (cusps 113) where two
concave (inwardly-curved) sides meet. While four exemplary
structural concave (inwardly-curved) sides 111 are shown for
illustrative purposes, one skilled in the art will readily
appreciate more or fewer concave (inwardly-curved) sides may be
employed by disclosed embodiments. One or more tracking marker
elements 106 are mounted onto one or more mounting posts 107, 108,
109 and 110 disposed, for example, at the intersection points of
the concave (inwardly-curved) sides 111. In the exemplary structure
DRF 101, one or more tracking marker elements 106 are mounted onto
one or more mounting posts 107 disposed at the rounded corners
(cusps 113) connecting the four concave (inwardly-curved) sides
111.
[0045] If the dynamic reference frame 100 is used as a fiducial
marker, the dynamic reference frame 100 may further comprise one or
more localization divots such as, for example, divots 112 disposed
at the top portion 102 of the exemplary DRF 101, illustrated in
FIG. 1. Localization divots disposed on DRF 101 allow a pointer
probe or any appropriate mechanism to determine the location of DRF
101 relative to the patient by engaging one or more divots in a
selected manner in patient space. In this way, a navigation system
comprising DRF 101 is able to determine the position of the DRF 101
relative to the patient. Furthermore, one or more localization
divots 112 may be pointed out in the pre-acquired radiological
patient image in order to register the image space with the patient
space. In this way detected movement of the DRF 101 may be used to
determine movement of the patient. It will be understood that the
one or more localization divots may be positioned in any
appropriate portion of DRF 101 but are generally provided in an
easily accessible and viewable area. Moreover, there may be
multiple divots 112 or landmarks, as discussed herein. The multiple
divots 112 may be used as fiducial markers. DRF 101 may also
include a radio-opaque material to be imaged in various imaging
techniques.
[0046] The location of the localization divots and mounting posts
for mounting the one or more tracking marker elements are denoted
by their respective x and y coordinates in the patient space.
Taking mounting post 107 as the origin point, parameters X1 and Y1
may represent the two dimensional 0,0 coordinate values,
respectively, in patient space. In the exemplary embodiment of FIG.
1, two-dimensional coordinate values of mounting post 108 for
mounting tracking marker 106, denoted in FIG. 1 as X2 and Y2, may
be selected from an applicable range approximately spanning from
4.722 to 4.732 and 0.258 to 0.268 inches, respectively. In
accordance to one exemplary embodiment, parameters X2 and Y2 may be
set to an optimal value of approximately 4.727 and 0.263 inches,
respectively. Parameters X3 and Y3, denoted in FIG. 1, represent
the two-dimensional spatial coordinates of mounting post 109. In
the exemplary embodiment of FIG. 1, spatial coordinated X3 and Y3
may be selected from an applicable range approximately spanning
from 0.042 to 0.052 inches and 4.248 to 4.258 inches, respectively.
In accordance to one exemplary embodiment, parameters X3 and Y3 may
be set to an optimal value of approximately 0.047 and 4.253 inches,
respectively. Parameters X4 and Y4, denoted in FIG. 1, represent
the two-dimensional spatial coordinates of mounting post 110. In
the exemplary embodiment of FIG. 1, spatial coordinated X4 and Y4
may be selected from an applicable range approximately spanning
from 5.041 to 5.1 inches and 4.098 to 4.108 inches, respectively.
In accordance to one exemplary embodiment, parameters X4 and Y4 may
be set to an optimal value of approximately 5.046 and 4.103 inches,
respectively. Parameters X5 and Y5, denoted in FIG. 1, represent
the two-dimensional spatial coordinates of localization divot 112
disposed at the top portion 102 of the DRF 101. In the exemplary
embodiment of FIG. 1, spatial coordinated X5 and Y5 may be selected
from an applicable range approximately spanning from 3.852 to 3.862
inches and 3.730 to 3.740 inches, respectively. In accordance to
one exemplary embodiment, parameters X5 and Y5 may be set to an
optimal value of approximately 3.857 and 3.735 inches,
respectively.
[0047] Disclosed embodiments of the DRF 101 may also provide
localization divots 114 and 116 disposed at front portion 118 and
back portion 120 of the DRF 101, respectively. Parameters X6 and
Y6, denoted in FIG. 1, represent the two-dimensional spatial
coordinates of localization divot 114 disposed at the front portion
118 of DRF 101. In the exemplary embodiment of FIG. 1, spatial
coordinated X6 and Y6 may be selected from an applicable range
approximately spanning from 2.538 to 2.549 inches and 4.052 to
4.062 inches, respectively. In accordance to one exemplary
embodiment, parameters X6 and Y6 may be set to an optimal value of
approximately 2.544 and 4.057 inches, respectively. Parameters X7
and Y7, denoted in FIG. 1, represent the two-dimensional spatial
coordinates of localization divot 116 disposed at the back portion
120 of the DRF 101. In the exemplary embodiment of FIG. 1, spatial
coordinated X7 and Y7 may be selected from an applicable range
approximately spanning from 2.501 to 2.511 inches and 0.528 to
0.538 inches, respectively. In accordance to one exemplary
embodiment, parameters X7 and Y7 may be set to an optimal value of
approximately 2.506 and 0.533 inches, respectively. Parameter D1
represents the vertical distance between the top surface 122 of DRF
101 and center point of localization divot 114 disposed at the
front portion 118 of the DRF 101 and denoted by two-dimensional
spatial coordinates X6 and Y6 in FIG. 1. Parameter D2 represents
the vertical distance between bottom surface 124 of DRF 101 and
center point of localization divot 116 disposed at the back portion
120 of the DRF 101 and denoted by two-dimensional spatial
coordinates X7 and Y7 in FIG. 1.
[0048] In some embodiments, DRF 101 may comprise an attachment
portal which may be used to attach DRF 101 to a connection or a
positioning member that may further be affixed to a patient's body
part or to a surgical instrument. In FIG. 1, top surface region 116
and 118, with center coordinates X8, Y8 and X8, Y9 (of exemplary
DRF 101) respectively correspond to an attachment portal and a
mounting pin (for securing the DRF to an external frame) disposed
at similar spatial coordinates on the bottom surface 124 (and
illustrated further in FIG. 2). Attachment portal correspond to
structure 126 in the back view and front view illustration of the
exemplary DRF 101 in FIG. 1.
[0049] Basic geometry dictates that at least three coordinate
points corresponding to three tracking marker elements are required
to define a tracking marker reference plane (two-dimensional
frame). However, preferably all four of the above mentioned
tracking marker elements 107, 108, 109 and 110 should be inputted
into the computer system to better define and correlate patient
space with image space corresponding to pre-acquired radiological
image.
[0050] Marker elements 106 may be designed as spherical marker
elements including retro-reflective marker spheres, also referred
to as passive reflective markers, and are widely used in image
guidance systems. Embodiments of retro-reflective marker spheres
may include those used to aid registration and instrument tracking
during image guided surgery procedures such as neurological
procedures, spine procedures and orthopedic procedures. Embodiments
may include retro-reflective marker spheres having a high
coefficient of retro-reflection on the external surface to provide
feedback to the system/camera. Such surfaces may consist of micro
glass spheres that reflect light. Depending on the medical
application, different numbers and arrangements of retro-reflective
marker spheres may be mounted on various types of surgical tools
that may be used including that disclosed herein. Once mounted on a
surgical probe, retro-reflective marker spheres provide an accurate
reference point for the surgical probe in three-dimensional
space.
[0051] Turning to FIG. 2, device representation 200 illustrating
top view of a bottom portion 202 of the exemplary DRF 101 and
longitudinal cross-sectional view of the front portion and back
portion localization divots 114 and 116, respectively as viewed
from the bottom or top perspective view. Localization divots 114
and 116 may comprise a tapered recess portion 115 and 117,
respectively for accommodating contact with, for example, a tip of
a pointer probe. Parameters D3, D4 and D5, denoted in FIG. 1,
represent the vertical offset of the front portion localization
divot 114, back portion localization divot 116 and mounting pin 204
relative to the attachment portal 126. Front portion localization
divot 114, attachment portal 126 and mounting pin 204 may have the
same X coordinate value and thus lie at different points along a
common vertical axis 206 in the plane of DRF 10. In the exemplary
embodiment, the back portion localization divot 116 is horizontally
offset from the vertical axis 206 by parameter D6. In the exemplary
embodiment of FIG. 2, parameter D3, D4, D5 and D6 may be selected
from an applicable range approximately spanning from 0.766 to 0.776
inches, 2.409 to 2.419 inches, 0.682 to 0.692 inches and 0.033 to
0.043 inches respectively. In accordance to one exemplary
embodiment, parameters D3, D4, D5 and D6 may be set to an optimal
value of approximately 0.771, 2.414, 0.687 and 0.038 inches,
respectively.
[0052] Turning to FIG. 3, the trackable top portion 102 of DRF 101
may comprise a set of one or more indicia 302 corresponding to a
plurality of functional icons, for example, on a touch screen or
GUI display, wherein each functional icon represents an executable
function. Conventionally executable functions of an electronic
device, such as an imaging controller system, may be activated
through a user interface (e.g., a keyboard, mouse, touch pen, touch
screen or other suitable device) thus allowing a physician or user
to provide inputs to control the imaging device. An added advantage
of the disclosed DRF 101 having the set of one or more indicia 302
includes the fact that DRF 101 is managed conveniently at the
location of the patient and is maintained as a sterile device.
[0053] In the described embodiment, physical locations associated
with elements of DRF 101 may be registered to the image space
locations which, in addition to the pre-acquired patient
radiological image, may also comprise a plurality of functional
icons graphically represented on the imaging display unit e. If the
area enclosing a particular indicia 302 (e.g., disposed on the top
surface 122 of DRF 101 in the patient space) is mapped onto the
image display area associated with the corresponding graphically
represented functional icons designated as part of the image space,
then the executable function associated with a functional icon may
be activated. For example, the executable function may be activated
by invoking a software routine to execute the function associated
with a functional icon. In one disclosed embodiment, this may occur
in accordance with a vector of movement of the touched position on
the top surface 122 of DRF 101, i.e., when a respective indicia is
touched on the trackable top portion of the dynamic reference
frame. This obviates the need to directly engage the computerized
user interface which is typically disposed at a work station away
from the operating table and, furthermore, may not be sterile.
Examples of techniques that may be useful in spatially mapping
physical objects to digital environments according to various
embodiments of the present invention are described in U.S. patent
application Ser. No. 09/250,267 to Maurer et al, entitled APPARATUS
AND METHOD FOR REGISTERING OF IMAGES TO PHYSICAL SPACE USING A
WEIGHTED COMBINATION OF POINTS AND SURFACES, filed Feb. 16, 1999,
U.S. patent application Ser. No. 10/418,187 to Galloway et al,
entitled METHOD AND APPARATUS FOR COLLECTING AND PROCESSING
PHYSICAL SPACE DATA FOR USE WHILE PERFORMING IMAGE-GUIDED SURGERY,
filed Apr. 16, 2003, and U.S. patent application Ser. No.
13/423,984 to Simon et al, entitled METHOD FOR REGISTERING A
PHYSICAL SPACE TO IMAGE SPACE, filed Mar. 19, 2012, the entire
contents and disclosures of which are incorporated herein by
reference.
[0054] FIG. 4 illustrates an exemplary placement of attachment
portal 126 and the mounting pin 204 disposed on the back portion
202 of DRF 101 relative to indicia 302 disposed on the front
portion 102 of the DRF 101. Parameter D7, denoted in FIG. 4,
represents vertical separation between top surface 402 of the front
portion localization divot 114 protruding beyond the plane of DRF
101 and an apex point 404 of the tapered recess portion 115
disposed in the front portion localization divot 114. Parameter D8,
denoted in FIG. 4, represents vertical separation between top
surface 405 of the back portion localization divot 116 protruding
beyond the plane of DRF 101 and an apex point 406 of the tapered
recess portion 117 disposed in the back portion localization divot
116. In the exemplary embodiment of FIG. 4, parameters D7 and D8
may be selected from an applicable range approximately spanning
from 0.161 to 0.171 inches and 0.168 to 0.177 inches, respectively.
In accordance to one exemplary embodiment, parameters D7 and D8 may
be set to an optimal value of approximately 0.166 and 0.172 inches,
respectively.
[0055] FIG. 5 illustrates DRF 101 highlighting to top surface
indicia, mounting post attachment locations of tracking marker
elements and top portion and front portion localization divots.
Accordingly, a perspective view of the exemplary DRF 101 depicts
top portion 102, signifying mounting posts 107, 108, 109 and 110
for stable positioning of one more tracking marker elements, remote
activation indicia 302 and localization divots 112 and 114 (back
portion localization divot 116 not shown). The geometrical shape of
the DRF is designed with rigidity and stability of the frame
structure to allow precise alignment of tracking marker elements.
This is accomplished, inter alia, by providing enough supporting
structure between mounting posts 107, 108, 109 and 110 (and, hence,
the respectively mounted tracking marker elements) while still
optimizing weight and manufacturing cost by reducing the amount of
material used in construction through integration of one or more
concave (inwardly-curved) sides 111 in the novel design of the DRF.
To this extent, DRF 101 is manufactured to a sufficient rigidity
to, thereby, inhibit planar misalignment of the top surface of
mounting posts 107, 108, 109 and 110 (and, hence, the respectively
mounted tracking marker elements, as further discussed below)
through structural warping of the frame. In some disclosed
embodiments, dynamic reference frame may be manufactured from
plastic materials. For example, the manufacturing process may
comprise molded plastic materials which allows reproducibility and
accuracy in design.
[0056] In some preferred embodiments, the plastic comprises
polycarbonate, polyetherimide (PEI) or another glass filled polymer
such as polyetheretherketone (PEEK). A PEEK product description
includes a high performance thermoplastic, unreinforced
polyetheretherketone, semi crystalline, including granules for
injection molding and extrusion, standard flow, FDA food contact
compliant, color natural/beige. PEEK is applicable for applications
for higher strength and stiffness as well as high ductility. It is
chemically resistant to aggressive environments and suitable for
sterilization for medical and food contact applications. PEEK
property data table is provided as follows:
TABLE-US-00001 TABLE 1 Nominal Value Nominal Value Test (English)
(SI) Method Physical Density ISO 1183 Crystalline 1.30 g/cm.sup.3
1.30 g/cm.sup.3 Amorphous 1.26 g/cm.sup.3 1.26 g/cm.sup.3
Mechanical Tensile Modulus 537000 psi 3700 Mpa ISO 527-2
(73.degree. F. (23.degree. C.)) Tensile Stress 14500 psi 100 Mpa
ISO 527-2 (Yield, 73.degree. F. (23.degree. C.)) Tensile Strain 45%
45% ISO 527-2 (Break, 73.degree. F. (23.degree. C.)) Flexural
Strength 73.degree. F. (23.degree. C.) (at yield) 23900 psi 165 Mpa
3.5% Strain, 73.degree. F. (23.degree. C.) 18100 psi 125 Mpa
257.degree. F. (125.degree. C.) 12300 psi 85.0 Mpa 347.degree. F.
(175.degree. C.) 2610 psi 18.0 Mpa 527.degree. F. (275.degree. C.)
1890 psi 13.0 Mpa Compressive Stress ISO 604 73.degree. F.
(23.degree. C.) 18100 psi 125 Mpa 248.degree. F. (120.degree. C.)
10200 psi 70.0 Mpa Hardness Shore Hardness 85 85 ISO 868 (Shore D,
73.degree. F. (23.degree. C.)) Thermal Heat Deflection ISO 75-2/A
Temperature 264 psi (1.8 Mpa), Un- 306.degree. F. 152.degree. C.
annealed Glass Transition 289.degree. F. 143.degree. C. ISO 11357-2
Temperature Melting Temperature 649.degree. F. 343.degree. C. ISO
11357-3 CLTE Flow: <289.degree. F. (<143.degree. C.) 0.000025
in/in/.degree. F. 0.000045 cm/cm/.degree. C. Flow: >289.degree.
F. (>143.degree. C.) 0.000067 in/in/.degree. F. 0.00012
cm/cm/.degree. C. Transverse: <289.degree. F. (<143.degree.
C.) 0.000031 in/in/.degree. F. 0.000055 cm/cm/.degree. C.
>289.degree. F. (>143.degree. C.) 0.000078 in/in/.degree. F.
0.00014 cm/cm/.degree. C. Specific Heat 0.526 Btu/lb/.degree. F.
2200 J/kg/.degree. C. DSC (73.degree. F. (23.degree. C.)) Thermal
Conductivity 2.0 Bti-in/hr/ft.sup.2/.degree. F. 0.29 W/m/K ISO
22007-4 (73.degree. F. (23.degree. C.)) Electrical Volume
Resistivity IEC 60093 73.degree. F. (23.degree. C.) 1.0E+16 ohm cm
1.0E+16 ohm cm 257.degree. F. (125.degree. C.) 1.0E+15 ohm cm
1.0E+15 ohm cm 437.degree. F. (225.degree. C.) 1.0E+9 ohm cm 1.0E+9
ohm cm Electric Strength IEC 60093 0.00197 in (0.0500 mm) 4800
V/mil 190 kV/mm 0.0787 in (2.00 mm) 580 V/mil 23 kV/mm Dielectric
Constant 73.degree. F. (23.degree. C.), 50 Hz 3.00 3.00 73.degree.
F. (23.degree. C.), 1 kHz 3.10 3.10 257.degree. F. (125.degree.
C.), 50 Hz 4.50 4.50 Fill Analysis ISO 11443 Melt Viscosity 350 Pa
s 350 Pa s (752.degree. F. (400.degree. C.)) Injection Drying
Temperature 248 to 302.degree. F. 120 to 150.degree. C. Drying Time
3.0 to 5.0 hr 3.0 to 5.0 hr
[0057] A polycarbonate product description includes a glass and
carbon fiber reinforced, mineral and process additive filled
structural compound material. The polycarbonate product may be
offered in all infinity base resins. The polycarbonate product
provides improvements in strength, stiffness, creep resistance,
fatigue endurance and impact and dimensional stability. Additional
properties include increased thermal heat deflection temperature or
heat distortion temperature (HDTUL) and long term heat resistance.
Polycarbonate property data table is provided as follows:
TABLE-US-00002 TABLE 2 Nominal Value Nominal Value Test (English)
(SI) Method Physical Specific Gravity 1.34 1.34 g/cm.sup.3 ASTM
D792 Specific Volume 20.7 in.sup.3/lb 0.747 cm.sup.3/g 1.26
g/cm.sup.3 Mechanical Tensile Strength (Yield) 16000 psi 110 Mpa
ASTM D638 Tensile Elongation 2.0 to 4.0% 2.0 to 4.0%i ASTM D638
(Yield) Flexural Modulus 1.00E+6 psi 6890 Mpa ASTM D790 Flexural
Strength 25000 psi 172 Mpa ASTM D790 Thermal Deflection Temperature
ASTM D648 Under Load 264 psi (1.8 Mpa), 295.degree. F. 146.degree.
C. Unannealed CLTE - Flow 0.000015 in/in .degree./F. 0.000027
cm/cm.degree. C./C. ASTM D696 Electrical Surface Resistivity
1.0E+17 ohm 1.0E+17 ohm ASTM D257 Injection Drying Temperature
250.degree. F. 121.degree. C. Drying Time 4.0 hr 4.0 hr Processing
(Melt) Temp. 540 to 630.degree. F. 282 to 332.degree. C. Mold
Temperature 200.degree. F. 93.3.degree. C.
[0058] Polyetherimide material (PEI) property data table is
provided as follows:
TABLE-US-00003 TABLE 3 ASTM Performance English SI Metric TEST
Specific Gravity 1.27 1.27 D 792 Melt Flow Rate @337.degree.
C.,/6.6 kg 17.80 g/10 min 17.80 g/10 min D 1238 Molding Shrinkage
1/8 in (3.2 mm) section 0.0050-0.0070 in/in 0.50-0.70% D 955
Mechanical Tensile Strength 16000 psi 110 Mpa D 638 Tensile
Elongation >10.0% >10.0% D 638 Tensile Modulus 0.52 .times.
10.sup.6 psi 3585 Mpa D 638 Flexural Strength 24000 psi 165 Mpa D
790 Flexural Modulus 0.50 .times. 10.sup.6 psi 3448 Mpa D 790
General Processing for Injection Molding Injection Pressure
12000-18000 psi 83-124 Mpa Melt Temperature 670-750.degree. F.
354-399.degree. C. Mold Temperature 275-350.degree. F.
135-177.degree. C. Drying 4 hrs @ 300.degree. F. 4 hrs @
149.degree. C. Moisture Content 0.04% 0.04% Dew Point -20.degree.
F. -20.degree. C.
[0059] In an alternative embodiment, DRF 101 may comprise a rigid
metal. The metal may comprise aluminum, anodized aluminum and
stainless steel. For 6000 Series Aluminum Alloy; Aluminum Alloy;
Metal; Nonferrous Metal, a property data table is provided as
follows:
TABLE-US-00004 TABLE 4 Component Wt. % Al 95.8-98.6 Cr 0.04-0.35 Cu
0.15-0.4 Fe Max 0.7 Mg 0.8-1.2 Mn Max 0.15 Other, each Max 0.05
Other total Max 0.15 Si 0.4-0.8 Ti Max 0.15 Zn Max 0.25
TABLE-US-00005 TABLE 5 Metric English Physical Properties Density
2.7 g/cc 0.0975 lb/in.sup.3 Mechanical Properties Hardness Brinell
95 95 Hardness Knoop 120 120 Hardness Rockwell A 40 40 Hardness
Rockwell B 60 60 Hardness Vickers 107 107 Ultimate Tensile Strength
310 Mpa 45000 psi Tensile Yield Strength 276 MPA 40000 psi Modulus
of Elasticity 68.9 GPa 10000 ksi Poisson's Ratio 0.33 0.33 Fatigue
Strength 96.5 Mpa 14000 psi Shear Modulus 26 GPa 3770 ksi Shear
Strength 207 Mpa 30000 psi Electrical Properties Electrical
Resistivity 3.99e-066 ohm-cm 3.99e-066 ohm-cm
[0060] Tracking marker element 106 may be designed as spherical
marker element including a retro-reflective marker sphere, also
referred to as passive reflective marker. Embodiments of
retro-reflective marker spheres may include those used to aid
registration and instrument tracking during image guided surgery
procedures such as neurological procedures, spine procedures and
orthopedic procedures. Embodiments may include a retro-reflective
marker sphere having a high coefficient of retro-reflection on the
external surface to provide feedback to the system/camera. Such
surfaces may consist of micro glass spheres that reflect light.
Depending on the medical application, different numbers and
arrangements of retro-reflective marker spheres may be mounted on
various types of surgical tools that may be used including that
disclosed herein. Once mounted on a surgical probe,
retro-reflective marker spheres provide an accuracy reference point
for the surgical probe in three-dimensional space.
[0061] Embodiments of marker element 106 may include internal
structures for receiving and mating with mounting post 107, 108,
109 and 110. In the disclosed embodiment, internal structure may be
designed to not only mount marker element 106 to mounting post 107.
108, 109 and 110, but ensure that marker element 106 is
consistently and accurately mounted such that full alignment is
maintained after mounting to dynamic frame reference 101.
[0062] For example, embodiments of the disclosed invention provide
an internal stop surface of the tracking marker elements 106 that
abut the top surfaces 502, 504, 506 and 508 of mounting post 107,
108, 109 and 110, respectively. As described earlier, the rigidity
and the structural stability of DRF 101 inhibits planar
misalignment of top surfaces 502, 504, 506 and 508 of mounting
posts 107, 108, 109 and 110, respectively. Top surfaces 502, 504,
506 and 508 of mounting posts 107, 108, 109 and 110 are configured
to align on a common horizontal plane that extends in parallel with
top surface 122 of top portion 102 of DRF 101. The internal stop
surface of tracking marker elements 106 may be mounted in abutment
with top surfaces 502, 504, 506 and 508 of mounting post 107, 108,
109 and 110, respectively. By doing so, a centerline of tracking
marker elements 106 may align on the same common horizontal plane
that extends in parallel with the top portion 102 of DRF 101. The
resultant coupling achieves precise inter-alignment of the one or
more tracking marker elements 106 onto DRF 101.
[0063] Furthermore, embodiments of the disclosed invention provide
that the materials and material characteristics described herein
are well suited for DRF 101 to be utilized as a disposable
single-use device being manufactured with tracking marker elements
106 pre-attached to the DRF during the manufacturing process. A
sterile single-use disposable DRF of the disclosed invention may be
packaged to maintain its sterile integrity and be made available
and ready for use upon request. In some embodiments, a preferred
design includes a design configuration wherein the setup of the
pre-attached tracking marker elements 106 is ready for use such
that the tracking marker elements 106 are correctly aligned along
DRF 101.
[0064] It is noted that tracking marker elements 106 may be mounted
to mounting post 107, 108, 109 and 110 by a user at the time of
operation. Alternatively, tracking marker elements 106 may be
pre-attached to mounting post 107, 108, 109 and 110 and ready for
use for an operation. Thus, in an exemplary operation, when a
surgeon opens a package containing the disclosed DRF 101, DRF 101
may be configured and employed within a surgical navigation system.
Upon assembly, the unique design of the disclosed embodiment
automatically and consistently aligns tracking marker elements 106
in alignment with suitable tolerance levels of the surgical
navigation system requirements. Disclosed embodiments provide a
carrier body for tracking marker elements defined by the
two-dimensional plane of DRF 101 designed to correctly align and
synch with the respective navigation system upon being integrated
therein. The integration with the rest of the navigation system may
occur, for example, via a mounting device coupled/mated with DRF
101 through the attachment portal 126. This facilitates enhancement
of the setup efforts of the navigation system in a cost efficient
manner and eliminates additional pre-registration and formatting
procedures.
[0065] Having described the many embodiments of the present
invention in detail, it will be apparent that modifications and
variations are possible without departing from the scope of the
present invention defined in the appended claims. For example,
disclosed embodiments may provide certain indicia and/or colors on
components of the disclosed disposable DRF device such as, but not
limited to, attachment portal 126, mounting pin 204, top portion
102, bottom portion 202, front portion 118, back portion 120,
concave (inwardly-curved) sides 111, mounting posts 107, 108, 109
and 110 and/or tracking marker elements 106. Such specific uses or
applications associated with said indicia and/or colors may be
employed, for example, in specific prescribed distinct surgical
procedures or in certain environments or medical situations, or by
specific groups of surgeons or individuals. These may include, but
not limited to, for example, use in neuro and ENT surgery, spinal
applications, soft/sensitive tissue applications and/or applying
force applications. Additionally, other custom features may be
employed and configured into the disclosed disposable DRF 101 such
as pre-fashioned and custom made ergonomic grips/handles attachable
to DRF 101. An example of a coloring scheme is presented as
follows:
TABLE-US-00006 TABLE 6 Color of Component (e.g., handle/grip) Probe
Name Tip Specific Orange Blunt Pointer Pointer used for Neuro and
ENT use; tip is slightly rounded (R 0.25 mm). Blue Sharp Pointer
Pointer used for spinal application; tip is harp, so that
anatomical landmarks on bones can be acquired. Green Ball Pin
Pointer Pointer for touching soft, sensitive tissue; tip with ball
(R 1.5 mm). Yellow Extra Strong Pointer for applying force, pointer
Pointer tip with big diameter (R 2.5 mm).
[0066] Furthermore, it should be appreciated that all examples in
the present disclosure, while illustrating many embodiments of the
present invention, are provided as non-limiting examples and are,
therefore, not to be taken as limiting the various aspects so
illustrated.
[0067] While the present invention has been disclosed with
references to certain embodiments, numerous modifications,
alterations, and changes to the described embodiments are possible
without departing from the spirit and scope of the present
invention, as defined in the appended claims. Accordingly, it is
intended that the present invention not be limited to the described
embodiments, but that it has the full scope defined by the language
of the following claims, and equivalents thereof.
* * * * *