U.S. patent application number 15/240233 was filed with the patent office on 2017-02-16 for robotic guide assembly for use in computer-aided surgery.
This patent application is currently assigned to OMNIlife science, Inc.. The applicant listed for this patent is OMNIlife science, Inc.. Invention is credited to Stephane Lavallee, Christopher Plaskos, Jacques Rit.
Application Number | 20170042557 15/240233 |
Document ID | / |
Family ID | 37073829 |
Filed Date | 2017-02-16 |
United States Patent
Application |
20170042557 |
Kind Code |
A1 |
Plaskos; Christopher ; et
al. |
February 16, 2017 |
ROBOTIC GUIDE ASSEMBLY FOR USE IN COMPUTER-AIDED SURGERY
Abstract
A system for guiding resurfacing operations on at least a
portion of a joint of at least one bone is provided and uses a
guide with actuators (motors) controlled by a computer to position
a cutting tool relative to a bone so that the bone surface can be
cut in a flexible and accurate manner.
Inventors: |
Plaskos; Christopher;
(Plymouth, MA) ; Lavallee; Stephane; (Saint Martin
D'Uriage, FR) ; Rit; Jacques; (Monte Carlo,
MC) |
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Applicant: |
Name |
City |
State |
Country |
Type |
OMNIlife science, Inc. |
Raynham |
MA |
US |
|
|
Assignee: |
OMNIlife science, Inc.
Raynham
MA
|
Family ID: |
37073829 |
Appl. No.: |
15/240233 |
Filed: |
August 18, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11908449 |
Aug 10, 2010 |
9421019 |
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PCT/IB2006/000806 |
Apr 7, 2006 |
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15240233 |
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60669177 |
Apr 7, 2005 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2034/105 20160201;
A61B 2034/108 20160201; A61B 17/1675 20130101; A61B 2034/107
20160201; A61B 34/30 20160201; A61B 2017/1602 20130101; A61B 34/20
20160201; A61B 2034/2055 20160201; A61B 34/10 20160201; A61B 17/155
20130101; A61B 2034/2068 20160201; A61B 17/1764 20130101; A61B
90/36 20160201 |
International
Class: |
A61B 17/17 20060101
A61B017/17; A61B 90/00 20060101 A61B090/00; A61B 34/30 20060101
A61B034/30; A61B 34/10 20060101 A61B034/10; A61B 34/20 20060101
A61B034/20 |
Claims
1-14. (canceled)
15. A method for performing computer assisted knee arthroplasty
comprising: tracking a position of a femur and a tibia of a knee
joint using a position measuring system; creating a
three-dimensional surface model of the femur using a computer
having computer instructions stored in a memory executable by a
processor to acquire data points from a pointer tracked by the
position measuring system, wherein the data points are various
points on a surface of the femur used in defining the
three-dimensional surface model of the femur; performing ligament
gap assessment between the tibia and femur at various flexion
angles of the knee joint; determining, with the use of the
computer, an optimal position and size of a femoral implant for
implantation on the femur based on the three-dimensional surface
model of the femur and ligament gap assessment at various degrees
of flexion of the knee joint, and positions of cutting planes
corresponding to the optimal implantation position of the femoral
implant on the femur; attaching to the femur a robotic cutting
system in communication with the computer; and aligning a cutting
guide of the robotic cutting system to each of the cutting planes
corresponding to the implantation position of the femoral implant
on the femur.
16. The method of claim 15, further comprising the step of
resecting the tibia before performing ligament gap assessment.
17. The method of claim 15, further comprising validating the
position and size of the femoral implant using the
three-dimensional surface model of the femur displayed on a display
screen of the computer.
18. The method of claim 17, further comprising updating at least
one of the optimal position and size of the femoral implant for
implantation on the femur after the step of validating.
19. The method of claim 15, further comprising validating the
position and size of the femoral implant using the
three-dimensional surface model of the femur displayed on a display
screen of the computer overlaid with the positions of the cutting
planes corresponding to the optimal implantation position of the
femoral implant on the femur.
20. The method of claim 15, further comprising: creating a
three-dimensional surface model of the tibia using the computer
having computer instructions stored in a memory executable by a
processor to acquire data points from the pointer tracked by the
position measuring system, wherein the data points are various
points on a surface of the tibia used in defining the
three-dimensional surface model of the tibia; attaching a navigated
tibial cutting guide to the tibia; and resecting the tibia using
the navigated tibial cutting guide.
21. The method of claim 15, wherein the step of aligning the
cutting guide includes rotating the cutting guide between the
cutting planes about a fixed distance from a rotational axis of the
robotic cutting system.
22. The method of claim 15, wherein the step of attaching includes
attaching the robotic cutting system to a medial side of the
femur.
23. The method of claim 15, further comprising resecting the femur
along at least one of the cutting planes and positioning the
cutting guide directly against a resected surface of the femur.
24. The method of claim 15, wherein the step of performing ligament
gap assessment includes recording ligament gap assessment values of
the tibia and femur at various flexion angles of the knee joint on
the computer.
25. The method of claim 15, wherein the step of creating the
three-dimensional surface model of the femur includes deforming a
generic surface model based on the acquired data points.
26. The method of claim 15, wherein the step of creating the
three-dimensional surface model of the femur includes matching
medical image data to the acquired data points.
27. The method of claim 15, wherein the pointer is an ultrasound
probe.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] The present application claims the benefit of U.S. patent
application Ser. No. 60/669,177, filed Apr. 7, 2006, which is
hereby incorporated by reference in their entirety.
TECHNICAL FIELD
[0002] The present invention relates to a method and system for
computer and robot aided surgery and more particularly, relates to
a robot-aided guide assembly that has a guide mechanism and cutting
tool for making precise bone cuts as part of a surgical procedure,
such as joint replacement or resurfacing operations.
BACKGROUND
[0003] The World Health Organization estimates that there is
currently several hundreds of millions of people suffering from
bone and joint diseases, and this figure is projected to increase
sharply due to the predicted doubling of the number of people over
50 by the year 2020.
[0004] Partial or total joint replacement or resurfacing is
currently one of the most popular methods of treating for patients
who suffer from bone and joint diseases, such as severe
degenerative joint osteoarthritis or arthrosis. For instance,
approximately 600,000 osetoarthritis patients worldwide undergo
total knee arthroplasty (TKA) every year to relieve their joint
pain and to restore their proper knee function with respect to
joint loading and kinematics. Uni-compartmental knee arthroplasty
(UKA), where only the medial or lateral condyles of the femur and
tibia are replaced is also a popular and is a less invasive
treatment for certain patients with knee osteoarthritis.
[0005] There are several different surgical techniques and forms of
implants used for both TKA and UKA. In conventional TKA, for
example, the surgeon strives to achieve accurate alignment by
adequately exposing the knee joint, properly orientating cutting
guide blocks across the exposed aspect of the bones from the
anterior side of the knee, and sawing off the worn joint surface by
using the block surface or slot to guide the oscillating
saw-blade.
[0006] To adequately expose the knee joint, the standard approach
used is a 25-30 cm skin incision extending proximally from just
distal to the level of the tibia tubercle (known as the anterior or
midline approach), followed by a medial 20-30 cm parapatellar
arthrotomy, which extends superiorly through the quadriceps tendon.
Although the extent of the incision allows for lateral evertion and
dislocation of the patella, thus exposing most of the structures of
the knee joint, dividing the distal third of the quadriceps muscle
in this manner can have several potential repercussions for the
patient. These include increased pain, blood loss, and time to
ambulation (both with and without walking aids), prolonged
post-operative hospital stay and rehabilitation, and decreased
range of motion and knee strength in daily tasks, such as stair
climbing and descending stairs, etc.
[0007] Minimally invasive surgical (MIS) techniques have been used
only for uni-condylar knee arthroplasty for over a decade, though
surgeons have only relatively recently begun to apply the
principles of MIS to TKA. In this technique, the knee joint is
accessed mainly from the side through a 6-9 cm incision instead of
a 20-30 cm incision. Approaching bone cuts medially or obliquely
instead of anteriorly circumvents the need to evert the patella and
violate the quadriceps. This, in turn, reduces morbidity by
reducing the trauma to the extensor mechanism, and improves
post-operative knee function, recovery rate and pain.
[0008] In TKA, implant alignment and positioning is regarded to be
one of the most important surgical variables for the long term
success of the operation. Implant alignment and positioning can be
described by the degrees of freedom associated with each implant.
For the femoral component these include three rotations, namely,
varus/valgus alignment, flexion/extension alignment, and
internal/external or transverse alignment; as well as three
positions, namely, anterior-posterior (AP) positioning,
proximal-distal (PD) positioning and medial-lateral (ML)
positioning. Most TKA femoral implants include an inner surface
comprised of at least five planes. The five cutting planes that
must be realized on the distal femur are the interior cut, anterior
chamfer cut, distal cut, posterior chamfer cut and posterior cut.
Other inner implant geometries consist of curved surfaces.
[0009] In order to accommodate these different surgical techniques
and implants, there exists several different types of bone-cutting
or resurfacing guides. These can range from rigid mechanical jigs,
to mechanized systems, to robotic cutting guides. Some of these
conventional guides are disclosed in U.S. Pat. Nos. 6,858,032 and
5,228,459; U.S. application publication No. 2005/0055028 and German
patent No. DE 203036643, all of which are hereby incorporated by
reference in their entireties.
[0010] Most of the above conventional systems use some type of
template to guide a cutting tool. However, all of these
conventional systems suffer from a number of deficiencies and in
particular, these systems do not provide all of the following
desired features: accuracy with respect to global implant
positioning; accuracy with respect to bone cut surface
reproducibility; flexibility in terms of implant type; flexibility
in terms of inner implant surface complexity, geometry and size;
compatibility with minimal access approaches; compactness;
simplicity and ease-of use.
SUMMARY
[0011] The present invention relates to a system for guiding
resurfacing operations on at least a portion of a joint of at least
one bone. The system uses a guide with actuators (motors)
controlled by a computer to position a cutting tool relative to a
bone so that the bone surface can be cut in a flexible and accurate
manner.
[0012] The system of the present invention includes a number of
components that cooperate with one another to perform the intended
guide and cutting operations. In particular, the system can include
fixation instrumentation, an orienting apparatus, a positioning
mechanism, and a guide assembly for guiding a cutting or milling
tool.
[0013] According to one embodiment, a system for guiding a cutting
tool capable of cutting bone portions at a level of a head of a
bone is provided and includes (a) means for attaching the system to
only one side of the bone through an incision in the bone; (b) an
adjustment mechanism rotatably coupled to the attachment means for
adjusting the position of the cutting tool; (c) a positioning
mechanism coupled to the adjustment mechanism and having at least
two degrees of rotational freedom for further adjusting the
position of the cutting tool; and (d) a guide intended to support
the cutting tool and pivotally coupled to the positioning mechanism
along one axis of rotation of the positioning mechanism.
[0014] These and other features and aspects of the invention can be
appreciated from the accompanying figures and the following
description.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
[0015] The foregoing and other features of the present invention
will be more readily apparent from the following detailed
description and drawings of the illustrative embodiments of the
invention wherein like reference numbers refer to similar elements
and in which:
[0016] FIG. 1 is a perspective view of an anatomical coordinate
system of a knee;
[0017] FIG. 2 is a perspective view of a computer and robot
assisted surgery system;
[0018] FIG. 3 is a robotic system for guiding joint replacement and
resurfacing operations on at least a portion of a point of at least
one bone;
[0019] FIG. 4a is a side elevation view, in cross-section, of a
fixation instrument for use with a guide system of the robotic
surgery system of FIG. 3;
[0020] FIG. 4b is a side elevation view, in cross-section, of a
variation of the fixation instrument of FIG. 4a.
[0021] FIG. 5 is a side elevation view, in cross-section, of the
fixation instrument of FIG. 4a inserted in a distal femur;
[0022] FIG. 6 is a side elevation view, in cross-section, of the
fixation instrument inserted in the distal femur with a pin guide
removed;
[0023] FIG. 7 is an exploded perspective view of a pin guide and
anchor of the fixation instrument of FIG. 4a;
[0024] FIG. 8 is a perspective view of an orienting apparatus of
the guide system of the computer assisted surgery system of FIG. 3
fixed to a side of the distal femur;
[0025] FIG. 9 is a cross-sectional view of the orienting apparatus
of FIG. 8;
[0026] FIG. 10 is a perspective view of a positioning mechanism
attached to the orienting apparatus with a milling system attached
thereto for performing resurfacing operations on the bone;
[0027] FIG. 11 is a perspective view of the positioning mechanism
of FIG. 10 attached to the orienting apparatus with a sawing guide
attached thereto;
[0028] FIG. 12 is a perspective view of the positioning mechanism
of FIG. 10 with the orienting apparatus and a milling system
attached thereto, as well as the fixation instrument;
[0029] FIG. 13 is a cross-sectional view of one exemplary brake
mechanism for the positioning mechanism;
[0030] FIG. 14 is a perspective view showing the modular nature of
the positioning mechanism;
[0031] FIG. 15 is a side perspective view of the milling system
milling the anterior cut plane with a straight side cutter;
[0032] FIG. 16 is a perspective view of the milling system and
guide system, with the milling system milling with a curved side
cutter that conforms to the curved inner shape of the implant;
[0033] FIG. 17 is a close-up perspective of the system of FIG.
16;
[0034] FIG. 18 is a perspective view of the milling system milling
with a ball end cutter;
[0035] FIG. 19 is a perspective view of a milling tool of the
milling system;
[0036] FIG. 20 is a cross-sectional view of the milling tool of
FIG. 19 illustrating a milling irrigation system; and
[0037] FIG. 21 is a flow chart of an exemplary surgical procedure
using the guide system of the present invention in a joint
replacement (TKA) operation.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0038] Referring now to FIG. 1, a perspective anatomical coordinate
system of the knee is illustrated. More specifically, a bone 2
(e.g., femur) is shown and includes a distal end 12. A
proximal/distal axis 20 is provided to show proximal and distal
directions relative to the femur 2. In addition, a medial/lateral
axis 30 is provided to show the medial and lateral portions of the
femur 2 and an anterior/posterior axis 40 is provided to show the
anterior and posterior portions of the femur 2. To assist in
performing resurfacing and cutting operations on the femur 2,
several reference planes are provided. In particular, a frontal
plane 50 is provided, a transverse plane 60 is provided, and a
sagittal plane 70 is provided. For purpose of illustration only, an
implant cut profile 80 is illustrated and projected onto the
sagittal plane 70 to illustrate the five planar cuts of a typical
total knee arthroplasty (TKA) femoral implant.
[0039] Referring now to FIG. 2, a computer-assisted orthopedic
surgery (CAOS) system 100 is schematically shown. The system 100 is
configured for performing joint replacement or resurfacing
operations, such as TKA. The system 100 can be used to plan the
optimal position of an implant, such as a knee implant, relative to
the bone 2, 3, and to position a guiding system such that the final
cut surface corresponds to the planned implant position cut
surface.
[0040] The system 100 includes a suitable position measuring device
110 that can accurately measure the position of marking elements in
three dimensional space and in the case of a knee implant, the
device 110 includes at least one bone, such as the patient's femur
2 or tibia 4. The position measuring device 110 can employ any type
of position measuring method as may be known in the art, for
example, emitter/detector or reflector systems including optic,
acoustic or other wave forms, shape based recognition tracking
algorithms, or video-based, mechanical, electromagnetic and radio
frequency systems. In a preferred embodiment, schematically shown
in FIG. 2, the position measuring system 110 is an optical tracking
system that includes at least one camera that is in communication
with a computer system 120 and positioned to detect light reflected
from a number of special light reflecting markers, such as spheres
or discs 130. The computer system 120 includes a display 122 to
permit visual display of the images.
[0041] Detecting and determining the position and orientation of an
object is referred to herein as "tracking" the object. To provide
precision tracking of objects, markers 130 can be rigidly connected
together to form reference bodies, (e.g., 140, 150), and these
reference bodies can be attached to bones, tools and other objects
to be tracked. One such device that has been found to be suitable
for performing the tracking function is the Polaris.TM. system from
Northern Digital Inc., Ontario, Canada. Objects to be tracked thus
typically include at least three markers (or triplets), which can
be configured to emit, receive, or reflect energy, such as light or
acoustic energy.
[0042] The position measurement device 110 is described in greater
detail in a number of publication, including U.S. patent
application Nos. 20050101966 and Ser. No. 11/299,287, both of which
were previously incorporated by reference.
[0043] To sense the position of light reflecting markers, the
system 100 includes at least two detecting elements, such as two
cameras. The two cameras detect the light reflected from the light
reflecting markers to determine the position of each marker
associated with the tracked object, the position and orientation of
the tracked object are also determined.
[0044] The position of the patient's bones, such as the patient's
femur 2 and the patient's tibia 4, can be determined and tracked by
attaching reference bodies 140, 150, which include respective
markers 142,152. Reference bodies can be attached to bones or tools
using pins or screws (144, 154), or various quick release
mechanisms. The reference bodies can also be shaped in the form
numbers (e.g., "1", "2", "3" . . . ) or alphabetical letters, such
as "F" for Femur, "T" for Tibia, "P" for pointer, and so on, so as
to avoid confusion as to which reference body should be attached to
which bone or tool.
[0045] The tracked objects and there relative positions can be
displayed on a screen that is connected to the computer system 120.
In a preferred embodiment, the display is a touch screen which can
also be used for data entry.
[0046] The position measurement device 110 includes a number of
different tools that are used at different locations and perform
different functions as the system 100 is operated to yield optimal
joint reconstruction data and information. These tools include the
above described markers, which act as landmark markers, as well as
other tools as will described in greater detail below, such as a
milling or cutting system 200 having at least three markers 202 is
an example of an object trackable by position measuring device 110.
The system also includes a pointer 160, with markers 162, which can
be used to digitize points on the surfaces of the femur 2 and tibia
4. The system 100 can further include a calibration device that can
be used to measure the relationship between a pointer tip 164 and
the markers 162. Accordingly, the markers 162 permit the position
or the pointer tip 164 to be determined from the positions of the
markers 162 relative to the three-dimensional coordinate system
170.
[0047] For sake of simplicity and with respect to the discussion of
FIG. 2, the system 200 is described as including a milling or
drilling device or any other type of cutting device 210 also has a
tip 212 having a known spatial relationship relative to markers
202. Position measuring device 110 determines the position and
orientation of markers 202 in the three dimensional coordinate
system 170. Based upon the known spatial relationship between the
tip 212 and markers 202, the position of the tip 212 is
determined.
[0048] Computer 120 is optionally configured to allow at least one
of medical image data and ultrasound data to be used in planning
the position and orientation of an implant in a bone. The
trajectory or path of a cutting surface being milled by the device
210 can be monitored and displayed by the computer 120. Thus, the
actual path can be compared to the previously planned cut path to
allow the practitioner to verify that there is no deviation between
the actual procedure and the preoperative plan. In one embodiment,
the device 210 is guided to allow the computer 120 to control the
milling or drilling path.
[0049] The system 100 also includes a plurality of reference bodies
140, 150, for determining the position and orientation of an
individual's bone in the three dimensional coordinate system 170.
The reference bodies 140, 150 are preferably rigid and include
respective markers 142, 152, which are preferably configured to
emit or reflect energy. Each reference body 140, 150 preferably
includes a respective attachment element, such as pins or screws
144, 154, with which the reference bodies can be releasably
attached to a bone. For example, the reference body 140 can be
attached to femur 2. The position and orientation of femur 2 can be
determined based upon the position and orientation of markers 142
attached thereto. Markers 142, 152 are sufficient to establish the
position and orientation of the rigid bodies 140, 150 within the
coordinate system 170.
[0050] The system 100 also includes the pointer 160 and can include
an endoscope in some applications, which cooperate to allow a
practitioner to digitize landmarks of the femur 2 and tibia 4.
Digitizing a landmark comprises determining the position of the
landmark in the three dimensional coordinate system, as discussed
below. The pointer 160 preferably includes a pointer tip 164 having
a known spatial relationship to the markers 162. Based upon the
known spatial relationship, the position of the pointer tip 164 can
be determined from the position and orientation of the markers
162.
[0051] The system 100 can further include a planar probe that
includes at least one planar surface for measuring the position and
orientation of the planar probe to be determined. Moreover, a
calibration system is preferably provided to measure the
relationship between at least one of the planar surfaces on the
probe and the markers. This relationship can also be determined by
using the pointer 160 to point to and locate at least three points
on the planar surface. Alternatively, the three points can have any
known spatial relationship relative to the planar surface. Thus,
the position of the planar surface can be determined from the
positions of the markers relative to the three-dimensional
coordinate system 170. In addition, other planar surfaces can be in
a known relative position with respect to the calibrated planar
surface or the three or more located points.
[0052] In a preferred embodiment of the invention landmark points
and or directions are digitized with respect to the femur 2 and
tibia 4 with the pointer and are stored in the computer. Preferably
an anatomical coordinate system for the femur and the tibia is
defined based on at least a portion of the acquired data. The
coordinate system could also be defined at least partially using
kinematic methods, such as fitting a plane to a trajectory (e.g.
fitting the sagittal plane 70 to the flexion/extension trajectory).
Possible landmark points include but are not limited to the tibial
plateau glenoids, spine, malleoli, the femoral notch, condyles, hip
center, bone surface areas, etc.
[0053] Now referring to FIGS. 2-20, the surgical system 100 is
preferably an integrated system in which each of the tools is in
communication with a master controller, such as the computer 120,
which serves to collect all of the data from the individual tools
and then process the data to calculate various measurements that
are displayable to the physician. The system 100 accordingly
includes a user interface that is supported by software in the
computer 120. The user interface is configured to assist and walk
the physician through the surgical procedure(s) to obtain optimal
results and to assist the physician in determining what the best
course of action is in terms of performing joint resurfacing and
bone cutting operations.
[0054] To perform computer assisted orthopedic surgery, especially
joint replacement or resurfacing, using the present system 10, the
reference body 140 is attached to the femur 2 at a selected point,
as by screwing the reference body 140 into the bone with screws
144. The reference body 140 includes the first set or triplet of
markers 142 that are thus fixed to the femur 2 at the point.
Similarly, the reference body 150 is attached to the tibia 4 at a
selected point by screwing the body 150 into the bone with screw
154. The reference body 150 includes the second set or triplet of
markers 152 that are likewise fixed to the tibia 4. Since the
reference bodies 140, 150 are fixed to the bones 2, 4, the pointer
tip 164 can be used to point at any given point on bone 2, 4, the
position of which is precisely taken by its tip 164. Then, it is
possible using a conventional data processing system to determine
the vector connecting the point where the respective body 140, 150
attaches to the bone 2, 4 to the point of the tip 164, and
therefore, locate any given point for any position of the femur 2
or tibia 4.
[0055] According to one exemplary method, a number of different
reference points are obtained. For example, the pointer tip 164 is
used to digitize certain surfaces of the tibia 4. Acquisition or
data points are also taken for the femur bone 2 and more
particularly, the pointer 160 is moved along the distal surfaces of
the femur bone 2. In all of these steps, the digitization occurs by
locating and logging a selected bone surface point in the three
dimensional coordinate system 170 and by using the data processing
system. In other words, the pointer tip 164 is moved along the bone
surface and coordinate data are gathered for use in generating a
morphological model of that bone portion. The pointer 160 can be
actuated to begin data acquisition by simply activating an
actuator, such as a foot pedal in which case it is merely depressed
by the physician. The above described digitizing process can be
thought of as a landmark acquisition process. Thus, according to a
preferred embodiment of the present invention, landmark points
and/or directions are digitized with respect to the femur 2 and the
tibia 4 utilizing the pointer 160 and are stored in the computer
120. Preferably, an anatomical coordinate system for the femur 2
and the tibia 4 is defined based on at least a portion of the
acquired data. The coordinate system can also be defined at least
partially using kinematic methods, such as fitting a plane to a
trajectory (e.g., fitting the sagittal plane to the
flexion/extension trajectory). As discussed in some detail above,
possible landmark points include but are not limited to the tibial
plateau glenoids, spine, malleoli, the femoral notch, condyles, hip
center, bone surface areas, etc. The data acquisition points can be
used to determine other information, such as locating a mechanical
axis of the tibia 4.
[0056] In a preferred embodiment of the present invention, three
dimensional geometrical surface models of the bones are provided by
image-free means. Preferably these models are obtained by adjusting
a deformable model of the bone to points acquired on the bone
surface. Examples of some known methods of carrying out this task
can be found in the following references: (1) "Building a complete
surface model from sparse data using statistical shape models:
application to computer assisted knee surgery" by M. Fleute and S.
Lavallee, published in Medical Image Computing And
Computer-Assisted Intervention--MICCAI '98, Spinger-Verlag LNCS
Series, pages 880-887, October 1998; (2) Fleute M, Lavallee S,
Julliard R. Incorporating a statistically based shape model into a
system for computer-assisted anterior cruciate ligament surgery.
Medical Image Analysis. 1999 September; 3(3):209-22. However, other
known methods of obtaining geometrical bone models in surgery exist
(for example, matching medical image data such as CT, MRI, etc, to
points acquired with a pointer or an ultrasound probe). Each of the
above listed references is hereby incorporated by reference in its
entirety.
[0057] In particular, the three dimensional shapes of the involved
bones may be provided with image free techniques, such as using
bone morphing software which is capable of extrapolating very few
range data to obtain a complete surface representation of an
anatomical structure (e.g., a bone). The specific details of bone
morphing are set forth in the above references but in general, a
complete surface model is built from sparse data using statistical
shape models. In particular, the model is built from a population
of a number of specimen (points), such as femur or tibia points,
that are digitized. Data sets are registered together using an
elastic registration method (e.g., the Szeliski and Lavallee
method) based on octree-splines. Principal component analysis (PCA)
is performed on a field of surface deformation vectors. Fitting
this statistical model to a few points in performed by non-linear
optimization. Results can thus be presented for both simulated and
real data. This method is very flexible and can be applied to any
structures for which the shape is stable.
[0058] In a preferred embodiment of the invention representations
of the femur and tibial bones, or a portion thereof, are displayed
on the screen. These models move on the screen in real time based
on the motion of tracked femur and tibia. In a preferred embodiment
of the invention the system guides the surgeon in manipulating the
knee, by using the bone representations as visual aids. Knee
manipulations are preferably preformed for both "normal" and
"abnormal" joint motions. Normal motions can include passive
flexion/extensions of the knee, with the tibia guided by the medial
and lateral femoral condyles. Abnormal joint motions are those
indicative of instability in the joint. In other words, the present
system preferably is configured to collect data with the pointer
160 in order to perform bone morphing operations or procedures to
thus obtain three-dimensional geometrical surface models of the
bones. The kinematic data obtained from such motions could also be
used to construct the BoneMorphing models, by for example, using
the normal direction of a best fit plane to initialize the model.
The knee manipulations may also be used to help plan the positions
of the implants, for example, to obtain optimal soft tissue
balancing around the knee. For example, a femoral component may be
positioned such that the gap space between the tibial cut and
femoral cut is equal when the knee is in flexion and in extension.
Tensors can also be used to balance the knee, for example to apply
equivalent forces on each condyle to distract the joint and create
joint spaces. The planning of the position of the implants may also
be a combination of soft tissue balancing criteria and bone
surface, alignment and landmark criteria. Examples of such planning
criteria are described in previously referenced United States
Patent application No. 20050101966. It is preferable that the
algorithm used to plan the position of the implants uses 3D
surfaces models of the implants. The 3D surface models of the
implants preferably include the outer implant surface and the inner
implant surface where the inner implant surface, or at least a
portion thereof, can correspond to the surface that needs to be cut
out of the bone. This cutting surface can contain planar surfaces
or more complex shapes such as curvilinear surfaces, spherical
surfaces, or any shape of surface for that matter.
[0059] Once the desired position of the implant has been
determined, the shape of the cutting surface on the bone can be
determined, and the boundary between the cutting surface and the
bone surface may be determined. Thus a perimeter around the desired
cutting area can be defined and displayed on the computer screen
122.
[0060] The system 100 is particularly suited for joint replacement
and resurfacing operations since the computer 120 can be configured
for identifying and applying the anatomical coordinate system 170
to at least two bones 2, 4 of the joint. The anatomical coordinate
system 170 can include directions, such as medial-lateral,
proximal-distal, anterior-posterior, and so on. The system 100 thus
can be configured for identifying landmark points on the surfaces
of the bones 2, 4. Furthermore, the system 100 can be configured to
measure the motion of one bone 2, 4 in space and to identify the
centers of adjacent joints from the measured trajectories. The
system 100 can measure the motion of one bone 2, 4 relative to
another for various arcs of joint motion and degrees of joint
rotation. In a further aspect, the present invention can provide a
system for determining intra-operatively the three-dimensional
shape of the bone surface in the vicinity of the articulating joint
and in particular, in the vicinity of the joint surface area to be
replaced. Preferably, the three dimensional shapes of the bones are
provided with image free techniques.
[0061] The computer and robot assisted surgery system 100 according
to one embodiment of the present invention is configured to provide
a system for guiding joint reconstruction or resurfacing operations
on at least a portion of a joint of at least one bone and includes
a number of different components that cooperate with one another to
perform the intended functions. As shown in FIG. 3, the system 100
can include fixation instrumentation (a fixation assembly) 300, an
orienting apparatus 400, a positioning mechanism 500, and guiding
instrumentation (guide assembly) 600 for guiding a tool 700, such
as a cutting tool, e.g., a saw-blade or milling tool.
[0062] FIGS. 4a-7 illustrate one exemplary fixation assembly 300
which is intended to secure the orienting apparatus 400 and the
positioning mechanism 500 onto the bone 2 (femur). As will be
described in greater detail hereinafter, the orienting apparatus
400 and the positioning Mechanism 500 are intended to align and
position the guide assembly 600 with respect to the intended
implant position in the femur 2. The guide assembly 600 is intended
to provide an interface between the positioning mechanism 500 and
the tool 700. As will be appreciated below, these system components
are constructed to introduce a number of degrees of freedom into
the system 100.
[0063] The fixation assembly 300 preferably includes a fixation
means 310 for rigidly fixing at least a part of the orienting
apparatus 400 to the femur 2. For example, the fixation means 310
can be in the form of a number of fixation fasteners 310 that fix
the orienting apparatus 400 to the femur 2. Suitable fixation
fasteners 310 include but are not limited to Stienman pins,
threaded pins, screws, cannulated screws, fixation nails, or other
types of fasteners. For ease of simplicity, these various means of
fixation will be hereinafter generally referred to as fixation pins
310. The fixation pins 310 are elongated structures and each can
include a head portion and typically includes a sharp, pointed
distal end 312.
[0064] The fixation assembly also includes an anchor element 320
that is fully or partially inserted inside the femur 2. The
illustrated anchor element 320 has an elongated body 322 that is at
least part hollow and includes a first open end 324 and an opposing
second closed end 326. The first open end 324 can include a first
locking or locating feature 326, such as a notch, for forming a
keyed type coupling with a guide element 330 described below. The
illustrated anchor element 320 has a cylindrical body 322 and
includes a number of through holes 328 passing therethrough, as
well as a having a central bore 325 that is open at the first end
324. More specifically, the through holes 328 are formed through
the side of the anchor element 320 between the first and second
ends 324, 326. The number of and the size of the through holes 328
are selected so that the through holes 328 accept the fixation pins
310. In other words, the fixation pins 310 are slidingly received
through the holes 328 in the body 322 so that they can pass
completely therethrough into the femur 2. The anchor element 320
can be relatively short so as not to enter substantially into the
intremedulary canal in the diaphyseal portion of the femur 2.
[0065] A cylindrical body 322 allows the surgeon to control the
rotational position of the fixation pins 310 with respect to the
bone 2 after the anchor 320 is inserted through the drill hole and
into the bone 10. Alternatively, a non-circular cross-sectional
shape could be incorporated into at least a portion of the anchor,
to block rotations and increase stability. For example, a star
shape could be used near the distal end of the anchor 320 so that
rotation can be controlled, while the anchor 320 is partially
inserted, and then fixed once it is fully inserted.
[0066] Alternatively, a longer anchor 320 that enters the
intramedullary canal at least partially could be used to improve
fixation stability if needed.
[0067] The guide element 330 is configured to be rigidly yet
removably attached to the anchor element 320 and can be used to
guide the insertion of objects so that it each engages one of the
through holes 328 formed in the body 322 of the anchor element 320.
For example, the guide element 330 can be used to guide the
insertion of the fixation pins 310 or guide wires or the insertion
of a bone drill or the like for making a hole in the femur 2, so
that these objects engage and pass through the holes 328 formed in
the body 322 to therefore be anchored to the bone 2. FIG. 4a
illustrates the guide element 330 being removably coupled to the
body 322 of the anchor element 320, while FIG. 5 shows these parts
inserted into the distal femur. FIG. 6 shows the anchor element 322
inserted into the distal femur with the fixation pins 310 passing
therethrough and the guide element 330 being removed.
[0068] As best shown in the exploded view of FIG. 7, the guide
element 330 includes a base portion or body 332 with an arm 334
extending outwardly therefrom. As best shown in FIG. 4a, when the
guide element 330 is mated with the anchor element 320, the base
portion 332 is disposed on an outside of the femur 2, while the arm
334 extends across ether below or above the bone, in this case
below the distal portion of the femur 2, so as to position the arm
334 in proper relationship with the anchor element 320 to permit
the anchor element 320 to be inserted into the distal femur 2.
[0069] The base portion 332 contains a number of through holes 335
formed therein which receive the fixation pins 310 and more
importantly, the holes 335 are substantially collinear with the
holes 328 in the body 322 of the anchor element 320 so that when
the fixation pins 310 are inserted and passed through the holes 335
of the guide element 330 they exit the body 322 and pass across a
space between the two bodies 322, 332 where the femur 2 is present,
through fixation holes formed in the femur 2 and then into the
holes 328 of the anchor element 320 as shown in the figures. It
will be appreciated that the holes 328, 335 are made substantially
collinear by fixedly attaching the guide element 330 in a
predetermined orientation relative to the anchor element 320. More
specifically, when the guide element 330 is coupled to the anchor
element 320, the proper alignment between the holes 328, 335
results. The holes 335 are thus substantially parallel to one
another. At least a portion of the pins could be threaded. As
illustrated in FIG. 4b, the pins 310 could also have a tapered
portion 380 somewhere along their length. Thus the pin can have
more than one diameter, and any portion can be threaded. The taper
in the pins can interface with a corresponding taper in the holes
of the anchor element 320, so that when the tapered portion of each
pin comes into contact with the anchor, a force is produced that
tends to push or pull the anchoring element against the bone for
increased stability.
[0070] In yet another instance of the invention, anchor element 320
can be constructed to expand inside the bone, for example, when at
least one fixation pin 310 is inserted. The expansion mechanism can
be realized in a number of ways. For example, the anchor element
320 can have a thin slot (not shown) cut thought it (for example,
about 1 mm thick), where the slot is coplanar to the axes of the
pin holes 380, dividing each of them into two portions, an anterior
and posterior portion. The slot can start from one end of the
anchor element (for example the distal or proximal end) and can
stop just before the opposite end, leaving some material at the
opposite end to act as a hinge or flexure joint to facilitate the
expansion action. The holes 328 in the anchor element can be
configured with a diameter smaller than the largest diameter of the
pin such that when pin 310 is inserted into hole 328, the larger
pin diameter enters the smaller hole and tends to expand the
effective diameter of the anchor element, elastically deforming the
flexure joint and prying apart the two inner faces of the slot. In
yet another variation of the invention, at least one of the holes
can be absent, allowing the complete diameter of the pin to pry
apart the anchor element when it enters the slot.
[0071] The arm 334 of the guide element 330 has a through opening
or bore 337 formed at a distal end thereof such that the bore 337
passes through an underside 338 to a topside 339 of the arm 334. An
axis of the bore 337 intersects axes of the holes 335 since the
axis of bore 337 is not parallel to the axes of holes 335.
[0072] It will be understood that the guide piece 332 can include a
sliding joint (not shown), such as a "dove tail" or "T" joint,
located between the arm 334 and pin holes 335, with a direction
parallel to pin holes 335. This allows the guide holes to be slid
directly up against the bone surface to increase rigidity during
drilling or pinning, while maintaining the co-linearity between the
guide holes 335 and the anchor holes 328. In addition, the guide
face that touches the bone surface can contain at least one sharp
spike to prevent it from sliding on the bone surface during pinning
or drilling.
[0073] In a preferred embodiment, the robot fixation pins 310 are
installed in the femur before the femoral reference marker 142 is
attached to the bone. The femoral reference marker 142 can then be
attached directly to the robot fixation pins 310, via a base
element 450 that fits and clamps onto the exposed portion of the
robot fixation pins (FIG. 3). This minimizes the amount of screws
placed in the bone. The femoral reference marker can be attached to
the base element via an extending structure 460 having several
centimeters in length, so as to ensure the reference marker is
visible by the camera and does not interfere with the robot or
other instruments during the procedure. The base element has a
coupling interface to connect with the robot manual orientation
system 400. In another embodiment, at least one of the manual
orientation degrees of freedom 432 is incorporated directly into
the base element. At any time during the procedure, the surgeon can
check if the fixation pins or reference marker has moved relative
to the bone by placing the point probe 160 on a confidence point
such as an identifiable point on the bone surface or on anther
small screw or pin (not shown) placed in the bone.
[0074] To couple the guide element 330 to the anchor element 320, a
coupling spacer 340 is provided to mate with and be disposed
between the arm 334 and the anchor element 320. The spacer 340 is a
generally hollow member that has a through bore 341 formed
therethrough from a first end 343 to a second end 345.
[0075] The arm 334 preferably includes a second locking or locating
feature 350 that is complementary to and engages a third locking or
locating feature 352 formed at the first end 343 of the spacer 340.
The spacer 340 also includes at the second end 345 a fourth locking
or locating feature 354. In the illustrated embodiment, both the
third and fourth locating features 352, 354 are in the form of a
tab or detent or protrusion formed at the respective end and
extending outwardly beyond the respective ends of the spacer 340.
The protrusions 352, 354 extend in opposite directions but along
the same axis of the spacer 340. The protrusion 354 is
complementary to the notch 326 so that it can be received therein
to couple the second end 345 of the spacer 340 to the anchor
element 320. Similarly, the protrusion 352 is complementary to the
slot or opening 350 formed in the arm 334. It will be appreciated
that when the protrusions 352, 354 engage the second locating
feature 350 (e.g., a longitudinal slot or notch formed in the arm
334) and notch 326, respectively, each of the three parts (anchor
320, guide 330 and spacer 340) is prevented from rotating
independent of the other parts. These locating features thus not
only locate each part relative to the other part but they also
rotationally lock each part with respect to the other parts.
[0076] As best shown in FIG. 7, the guide element 330, spacer 340
and anchor 320 are coupled to one another by means of a fastener
370, such as a pin. The pin passes through the bore 337 formed in
the arm 334, then passes through the bore 341 of the spacer 340 and
into the bore 325 of the anchor element 320. Advantageously, the
guide element 330, as well as the spacer 340, can be made to
disassemble from the anchor element 320 so that is can be removed
and not interfere with the cut after the fixation pins 310 have
been properly inserted into the femur 2. The entire anchor fixation
system defined by the above parts has the advantage of increased
rigidity in particularly soft or weak bone, which is often present
in patients suffering from osteoarthritis. However, in patients
with very hard and strong bones, using fixation pins 310 or screws
alone can be enough to obtain a sufficiently rigid connection.
[0077] Once the fixation pins 310 have been properly located in the
femur 2 to support the other components of the overall system 100,
the orienting apparatus 400 is then attached to the fixation pins
310. FIG. 3 illustrates one exemplary orienting apparatus 400
according to the present invention. The orientating apparatus 400
is generally formed of two parts, namely a base 450 and a second
part 455 that is movably coupled to the base 410 and provides an
interface to the positioning mechanism 500 (FIG. 3). The base 450
has a body 458 that attaches to the fixation pins 310 by a number
of different means, including providing a clamping mechanism. Such
a claming mechanism can be realized using a slot 457 cut out of the
body 458, where at least a portion of the slot intersects with the
two axes of the fixation pins 310. A clamping screw 456, can be
arranged in-between in between the two pins such that when the
screw 456 is tightened, the body 458 flexes and clamps onto the
fixation pins 310. Slot 457 can be made by wire cutting, for
example, and the slot path cut can be made so as to have two areas
of flexure in the body 458 such that the clamping action is a
parallel one, applying a more or less equally on force on each
fixation pin.
[0078] FIGS. 8 and 9 illustrate another exemplary orienting
apparatus 400 according to the present invention. Again, the
orientating apparatus 400 is generally formed of two parts, namely
a base 410 and a second part 420 that is movably coupled to the
base 410 and provides an interface to the positioning mechanism
500. The base 410 has a body 412 that attaches to the fixation pins
310 by a number of different means, including providing
complementary fastening members, such as threaded screws 414,
associated with the body 412. These screws 414 can be used to
rigidly fix the base 410 of the orienting apparatus 400 onto the
pins 310. The fixation pins 310 are aligned with the screws 414,
which are then tightened to cause the base 412 to be securely and
fixedly attached to the fixation pins 310. As illustrated, the
screws 414 run along a length of the base 410.
[0079] The sliding joint described above provides a means of easily
separating the fixation assembly 300 from the base 410 or 450.
[0080] In another embodiment, the base 410 or 450 of the orienting
apparatus 400 is integral to the fixation assembly 300 and more
particularly, to the pin guide 330 and fixation pins 310 such that
once the fixation pins 310 are inserted, the base 410 is already
fixed upon the femur 2. This will save considerable time and effort
during the fixation step of the procedure since the step of fixedly
attaching the orienting apparatus 400 to the fixation pins 310 is
eliminated.
[0081] The second part 420 is movably attached (e.g. pivotally) to
the base 410 so as to provide the orienting apparatus 400 with at
least one rotational degree of freedom. This rotational degree of
freedom rotates in a direction that is generally aligned with the
varas/vargus direction of the implant. As is known in the field,
the term "varus" refers to an inward direction and the term
"valgus" refers to an outward direction and these terms refer to
the direction that the distal part of the joint (or bone depending
upon the point of reference) points. This degree of freedom can be
lockable by means of a fastener, such as a screw, or by means of a
quick locking cam mechanism.
[0082] Preferably, the orienting apparatus 400 includes another
rotational degree of freedom. As illustrated in FIGS. 3, 8, and 9,
the orienting apparatus 400 can include a first rotational degree
of freedom along axis 430 and a second rotational degree of freedom
along axis 432, with one of these rotational degrees of freedom
being in the varas/vargus direction and the other being generally
aligned with the transverse rotation directions of the implant.
This additional rotational degree of freedom can likewise be
lockable by means of a fastener (screw) or by means of a quick
locking cam mechanism.
[0083] As best shown in the cross-sectional view of FIG. 9, the
rotatable second part 420 is connected to the base 410 at least
along the axis 430 as by means of a first shaft or the like 434 to
thereby permit the second part 420 to rotate about the axis 430.
The second part 420 includes a body 422 that is rotatably coupled
to the first part 434 to permit rotation of the body 422 about the
first axis 430. The body 422 of the second part 420 is also
preferably rotatably coupled to a second part 436 to permit
rotation of the second part 420 about the second axis 432.
[0084] Thus, the body 422 has at least two degrees of rotational
freedom with respect to the base 410. In this manner, the orienting
apparatus 400 (adjustment system) is similar to a universal joint,
with two rotational axes arranged perpendicular and intersecting to
one another as illustrated in FIGS. 8-9. These two rotational axis
can also be non-intersecting as shown in FIG. 3. Here, the
varus/valgus rotation axis 432 is along the axis of screw 456, and
the internal/external rotation axis 430 is about pin 452. The body
422 of the second part 420 includes a mounting or interface section
generally indicated at 440. This section 440 can be in the general
form of a mounting plate which is preferably planar in nature as
illustrated. As described below, the positioning mechanism 500 is
coupled to the orienting apparatus 400 by being mounted to the
section 440. The section 440 is formed along one face of the body
422 that faces away from the base 410. In the illustrated
embodiment, the section 440 has a pair of spaced, outwardly
extending wings or tongues 442 that have openings 444 formed
therethrough to receive fasteners or the like to fixedly couple the
positioning mechanism 500 to the orienting apparatus 400. In
another embodiment, especially when only the fixation pins 310 are
used alone, the orienting apparatus 400 can be fixed as indicated
in FIGS. 3 and 10, such that rotational axis 432 corresponds to the
"varus" rotation.
[0085] In one embodiment and as will be appreciated more below, the
fixation assembly 300 and the orienting apparatus 400 provide a
fixation and adjustment system that secures the robotic components
of the present invention to the femur 2 and incorporates a two
degree of freedom adjustment mechanism which permits the surgeon to
align (e.g., manually) an axis associated with the robotic
component to the implant profile in both the frontal and transverse
(or axial) planes 50, 60 (FIG. 1).
[0086] The positioning mechanism 500 is connected to the orienting
apparatus 400 and similar to the orienting apparatus, the
positioning mechanism 500 is constructed so that it has a
rotational degree of freedom. More specifically, the positioning
mechanism 500 is constructed so that it includes at least two
rotational degrees of freedom that have rotational axes arranged
substantially parallel to one another, and substantially orthogonal
to the axes 430, 432 of rotation of the orienting apparatus 400.
Thus, the rotational axes of the positioning mechanism are
substantially parallel to the flexion/extension axis of the
implant.
[0087] As shown in FIGS. 10-18, the positioning mechanism 500
includes a body 510 that has a first section 512 and a second
section 514 spaced therefrom. Each of the first and second sections
512, 514 includes an arm or finger 516, 518, respectively, at
distal ends thereof and includes head portions 517, 519 at opposite
ends thereof for mating with an actuator as described below. The
first section 512 includes a first rotational axis 520 (FIG. 3) of
the positioning mechanism 500, while the second section 514
includes a second rotational axis 522 (FIG. 3) of the positioning
mechanism 500 which is substantially parallel to the first
rotational axis 520. In the illustrated embodiment, the first
section 512 and therefore, the first rotational axis 520, is
coupled to the orienting apparatus 400, while the second rotational
axis 522 is attached to the guide assembly 600, which provides an
interface between the positioning mechanism 500 and the tool 700.
As previously mentioned, the orienting apparatus 400 and the
positioning mechanism 500 are intended to align and position the
guide assembly 600 with respect to the intended implant position in
the femur 2.
[0088] A central section 515 separates the first and second
sections 512, 514, such that the first and second rotational axes
520, 522 of the positioning assembly 500 are separated by a
distance such that the combined rotation of the first and second
rotational axes 520, 522 changes the guide assembly 600 positioning
in the sagittal plane 70 (FIG. 1) in one rotational degree of
freedom, as well as two translational degrees of freedom. These
degrees of freedom correspond substantially to flexion/extension
implant rotation, AP implant positioning, and PD implant
positioning.
[0089] Within each of the first and second sections 512, 514, there
is a rotatable element, such as a shaft, that rotates about one of
the first and second rotational axes 520, 522, respectively. In
other words, the first section 512 has a first rotatable element
associated therewith, while the second section 514 has a second
rotatable element associated therewith. Each of the first and
second rotatable elements is operatively coupled to an actuator or
the like that selectively imparts controlled rotation to one of the
first and second rotatable elements. At the distal ends of the
first and second sections 512, 514, the first and second rotatable
elements can be operatively coupled to another member, such as the
orientating apparatus 400 or the guide assembly 600, to translate
rotation to the members or to rotate the positioning mechanism 500
relative to the member, keeping the cutting guide axis
substantially aligned with the axes 522, 520.
[0090] The two rotational axes 520, 522 of the positioning
mechanism 500 can be actuated manually or the axes 520, 522 can be
actuated in an automated manner. The actuation can be caused by any
number of different types of mechanisms, including any type of
actuation motor, including electromagnetic, piezoelectric,
brushless, stepper, pneumatic, etc., or the actuation can be caused
by any other known means of actuation. For ease of illustration,
the actuation of the rotatable elements is discussed as being
caused by an actuator, such as a motor, which is generally
indicated at 550 and is associated with one of the rotation axes
520, 522 of the positioning mechanism 500. Thus, the positioning
mechanism 500 can be discussed as having a pair of actuators 550
for the two rotatable elements in the two sections 512, 514. The
actuators 550 can be in the form of a single module (FIG. 14) or
motor pack that is operatively coupled, in a detachable manner, to
the heads 517, 519 of the positioning mechanism 500 such that each
of the first and second rotatable elements in the two sections 512,
514 is operatively coupled to one of the actuators 550 (motor or
the like). The actuators can thus be in the form of a pack that
contains two independently operated motors and is configured to
detachably interlock with the two heads 517, 519 of the positioning
mechanism 500. The body 510 of the positioning mechanism 500 can be
thought of as a gear and brake unit that is detachably coupled to
the actuator (motor) unit 550.
[0091] In another different embodiment, the motors are directly
integrated into the gear unit such that they are in the same
housing, as illustrated in FIG. 3. In particular, the motors can be
arranged within the housing 500 so that they lie in between 524 the
two axes of rotation 520 522, and are connected to the axes via
gears, for example, spur gears (not shown). This makes for a
particularly compact unit.
[0092] In the automated embodiment, where the two rotatable
elements are actuated automatically, the surgeon does not have to
align manually by hand both the flexion/extension implant rotation
and the AP and PD implant positioning. This results in a savings of
time during the position step of the procedure and makes the
overall system 100 easy to use for the surgeon. Furthermore,
precision gears can be included at each rotational axis 520, 522
(e.g., at each rotatable element) of the positioning mechanism 500
to increase the guide positioning accuracy. It will therefore be
appreciated that upon actuation, one of the rotatable elements is
rotated about its respective rotational axis to directly translate
a rotational force to the member that is operatively coupled
thereto. In the case when the first rotatable element is coupled to
the orienting apparatus 400, the orienting apparatus 400 can be
caused to rotate about the first rotational axis 520, while when
the second rotatable element is attached to the guide assembly 600,
the guide assembly 600 and the tool 700 attached thereto can be
caused to rotate about the second rotational axis 522.
[0093] The positioning mechanism 500 can also include a brake
mechanism 560 as shown in FIG. 10. The brake mechanism 560 is
constructed to prevent the first and second rotatable elements from
rotating about rotation axes 520, 522 as long as the brake is not
released. The brake mechanism 560 can be electromechanical or
manual and can be spring loaded such that the surgeon must interact
with an interface, such as for example, the pressing of a button
562 or turning of a knob to disengage the brake mechanism 560. In
addition, the brake mechanism 560 can be configured so that a
single interface button disengages the brake mechanisms from both
rotation axes 520, 522 simultaneously. The brake mechanism 560 can
be configured to block rotation at the transmission level of the
precision gear reducer inputs so that any small rotational
deviations caused by the engaging action of the brake are reduced
by the gear reduction ratio at the guide positioning level.
[0094] According to one exemplary embodiment, the brake mechanism
560 is in the form of a manual spring-loaded brake that is disposed
in between the zero-backlash gear inputs and the motor outputs. In
this embodiment, the surgeon must hold the safety button 562 in
order to release the brake and free both gear inputs to rotate.
[0095] Using brake mechanism 560 has several advantages for safety
and convenience. When using actuators (e.g., motors) to position
the guide assembly 600 (e.g., cutting guide), the brake mechanism
560 ensures that (1) the guide assembly 600 maintains its position
regardless of the state of the actuators; and (2) the actuators
cannot move the guide assembly 600 unexpectedly if the button 552
is not depressed. Additionally, since the actuators 550 can be
removably attached to the gear unit of the positioning mechanism
500, they can be easily replaced during the procedure in case of
failure or malfunction. A system that is configured with brake
mechanism 560 and removable actuators 550 also has the advantage
that the overall weight of the positioning mechanism 550 can be
reduced during the cutting stage. Because of the quick-release
brake mechanism 560, the surgeon only needs to mount the motors 550
to the gear interface that can be present in the heads 517, 519 of
the positioning mechanism 500 before making each of the five
femoral TKA cuts to align the guide assembly 600 to the cutting
plane.
[0096] Since the brake mechanism 560 bears the loads applied to the
guide assembly 600 during the cutting phase, the motors 550 need
only provide enough power to position the cutting guide assembly
600. The motors 550 can be lower torque motors 550 that provide
sufficient torque to lift the cutting guide 600 with the brake
released, but not enough force to pose any significant threat.
Moreover, the surgeon can overpower the motors 550 and backdrive
the system in the case of a controller malfunction. In case of a
motor or cable failure in surgery, the actuators 550 are designed
as a modular system in which the motors 550 are encapsulated in a
separate housing so that they can easily be detached from the gear
unit in the positioning mechanism 500 and replaced. Therefore, this
configuration allows a hospital to use the motors 550 until the end
of their lifespan and then to dispose and replace the motors 550
after failure without having to stop the surgery and dismount the
robotic parts. Finally, because of the quick-release brake
mechanism 560, the surgeon only needs to mount the motors 550 to
the gear block interface in the positioning mechanism 500 before
making each cut to align the guide assembly 600 to the cutting
plane, the motor unit and power cable do not need to be connected
to the robot during a cutting phase or milling phase when the
surgeon is typically standing directly beside the knee. This
permits the guide 600 to be very compact and lightweight. This
option becomes more important in patients having very poor quality
bone where the fixation rigidity could be compromised.
[0097] One exemplary guide assembly 600 is shown in FIG. 11 and the
modular nature of the system 100 of the present invention permits
attachment to the various cutting guide interfaces 600, such as
saw-guides or milling tool guides. FIG. 11 shows an exemplary
saw-blade guide 610 being attached to one of the first rotatable
element associated with the first section 512 of the positioning
mechanism 500. The illustrated saw-blade guide 610 preferably
includes a slot for receiving a saw-blade. The saw-blade guide 610
can include a linear sliding joint in the plane of the cut so that
the saw-blade tip can always be slid up to the start of the cut.
This permits the saw-blade guide 610 to slide linearly in the
direction indicated by the arrow 601.
[0098] The illustrated saw-blade guide 610 includes a guide arm 620
that extends outwardly from the positioning mechanism 500 and is
operatively coupled to the first arm (distal end) 516 of the first
section 512 such that rotation of the first rotating element about
the first rotation axis 520 results in rotation of the attached
saw-blade guide 610 and guide arm 620 about the first axis of
rotation 520. In this way, the guide assembly 600 can be rotated to
a desired location during the procedure so as to position the tool
700 which in the case of a saw-blade guide 610 is a saw-blade 700.
By providing slot 622 and the linear movement along the arrow 601,
this has the advantage to position the saw-guide directly up
against the femur 2, minimizing the unsupported distance of the
blade between the edge of the saw-guide slot 622 and the femur 2.
This can minimize the cutting errors due to saw blade bending and
skiving.
[0099] In order to position the saw-blade guide 610 as close as
possible to the inner edge of each cut, a specific cutting order
can be used. In particular, if the distal cut is made first, then
making an anterior chamfer cut before making the anterior cut
results in the saw-blade guide 610 being positioned at the start of
both the anterior chamfer cut and the anterior cut. Similarly,
making the posterior chamber cut before the posterior cut results
in the saw-blade guide 610 being positioned at the start of both
the posterior chamfer cut and the posterior cut.
[0100] FIGS. 12-13 illustrate the guide assembly 600 in the form of
a milling guide 630 that is configured to be attached to the
positioning mechanism 500 to guide a milling tool 700 instead of
the saw-blade guide 610. As shown in FIG. 12, the milling guide 630
is rotatably coupled to the first rotatable element of the second
section 514 of the positioning mechanism 500. The illustrated
milling guide 630 includes a base portion 632 that can include a
boss or shaft 634 that is operatively attached to the first
rotatable element so that rotation of this element causes the base
portion 632 and the remaining part of the milling guide 630 to
rotate. A pair of guide arms 636 are provided and are integrally
attached at first ends 637 to the base portion 632. The guide arms
636 are spaced apart from one another so that a space 639 is
provided between the two guide arms 636, with the boss 634 being
disposed between the two guide arms 636.
[0101] The distal second ends 638 of the guide arms 636 are open
ends and preferably a milling tool joint 640 is disposed between
the two second ends 638 of the arms 636. The milling tool joint 640
has a body 641 with one face 642 that is rotatably coupled to one
arm 636, while the other face 646 of the tool guide block 640 is
rotatably coupled to the other arm 636. The body 641 is thus
capable of rotating about an axis within the space 639 formed
between the two guide arms 636, as illustrated by the arrow 645
(FIG. 3), to thereby permit the tool 700 itself to be rotated
relative to the milling guide 620, which itself can be rotated
about the first rotation axis 520. In other words, the milling tool
guide 620 for making planar cuts, such as those performed in TKA,
can include at least one rotational degree of freedom (indicated by
arrow 645 in FIG. 3) and at least one translational degree of
freedom in the cutting plane, indicated by arrow 647 (FIG. 3).
Thus, the joint 640 includes both elements of rotation and
translation and therefore, can be thought of as having a rotational
degree of freedom and a translational degree of freedom. The
translational degree of freedom joint axis can be parallel to the
axis of rotation of the milling tool 700. The axis of the milling
tool 700 can intersect at right angles the rotational degree of
freedom axis so as to avoid causing a moment about the rotational
axis when sliding the milling tool in the translational direction,
indicated by arrow 647 (FIG. 3). The rotational joint can be
connected to the milling guide 620 and the translational joint can
be connected to the rotational joint so as to realize a very
compact form with a large range of motion.
[0102] At least one of the two degrees of freedom of the milling
guide 620 can be lockable. Preferably, the degree of freedom that
is lockable is the translational degree of freedom. This allows the
surgeon to make the cut in sweeping motions using one degree of
freedom at a time. These sweeping motions give better and more
stable control of the milling tool 700 while making the cut.
[0103] The interface between the milling tool attachment piece 710
and the translational joint 640 can be indexed so as to allow the
milling tool 700 to be advanced in discrete intervals. As shown in
FIGS. 12, 15 and 19, the milling tool 700 includes a base or body
702, with the tool attachment piece 710 being in the form of an
elongated shaft having a distal tip 712 and extending outwardly
from the body 702. The attachment piece 710 or shaft includes a
number of indexing features 720 formed at spaced intervals along a
length thereof. For example, the indexing features 720 can be in
the form of circumferential notches formed in the attachment piece
710 and spaced apart from one another a predetermined distance. The
distance between two consecutive notches 720 can be the same or the
distance can be different. Preferably, these intervals are
substantially equal to or slightly less than the axial length of
the cutting tool 700. This maximizes cutting efficiency for a given
milling cutter and minimizes the number of passes used to make the
cut. Preferably, the indexing system is configured so that it can
be switched on or off to accommodate surgeon preference or to allow
simultaneous two degrees of freedom motion for following complex
trajectories, for example, along the perimeter of a cut plane. In
one embodiment, each notch 720 is numbered to provide data
indicative of how deep the milling tool 700 is in the patient.
[0104] It will also be appreciated that both the cutting device and
the milling device 700 has at least three markers so that the
device is trackable by the position measuring device 110 using the
coordinate system 170. In particular, the milling device 700 has an
axis that has a known spatial relationship relative to the markers.
Based upon the known spatial relationship between the drill or
milling tip and markers, the position of the drill or milling tip
is determined.
[0105] Preferably, the milling tool guide 620 can include a slot
for guiding a saw-blade, permitting the milling tool 700 to be used
for some cuts and the saw-blade to be used for the other cuts. This
is particularly useful for making the posterior cut which is
surrounded by soft tissues. The use of a continuously rotating
cutting tool, such as the milling tool 700, may in some
applications be associated with a higher potential risk than with
an oscillating saw-blade. The above slot can also be used to attach
a rigid body, for example, the planar probe 160 of the system
100.
[0106] FIGS. 19-20 show the milling tool 700 in greater detail. The
distal tip 712 of the milling attachment piece 710 contains a
fluted bearing 730 for supporting the rotating cutter and for
allowing fluid to pass through to irrigate the cutting side. The
bearing 730 can be made out of low friction plastic materials and
can also be disposable. The use of irrigation fluid helps to reduce
the friction. FIG. 20 illustrates a milling irrigation system.
Fluid enters through the base 716 of the attachment piece 710, as
indicated by arrow 715, and travels within an interior bore of the
attachment piece 710 before exiting through the fluted bearing 730,
as indicated by arrow 731, to irrigate the cutting site in the
vicinity of the cutting tool 700. A low profile ball or needle
bearing that allows the fluid to pass in between the balls or
needles can also be used.
[0107] Now referring to FIGS. 16-19 and according to another
embodiment, the milling system of the present invention can be
configured so as to allow the machining of non-planar cut surfaces.
In this configuration, the longitudinal axis of the milling tool
700 is arranged so that it is parallel to the two rotational axes
520, 522 of the positioning mechanism 500 and the translational
degree of freedom is used so as to drive the milling tool 700 along
its axis. Here the positioning (motorized) mechanism degrees of
freedom can be used to guide the motion of the milling tool 700
along the direction of the cut. The milling tool can be advanced
along the cut by for example holding down the control system
footswitch. The robot thus only moves the cutting tool whilst the
footswitch is pressed and held down. Different footswitches can be
used to control movement in different directions along the cut
path. Alternatively, a force sensor can be incorporated into the
robot and the movement can be controlled as a function of the
forces applied by the surgeon. Thus the surgeon can directly
control the position of the milling tool and feel the forces on the
robot during cutting. Such control systems exist and are known,
such as that used by the ACROBOT robotic system. Such systems are
described in many publications, including Cobb J, Henckel J, Gomes
P, et al, Hands-on robotic unicompartmental knee replacement,
Journal of Bone and Joint Surgery--British Volume, 2006, Vol: 88,
Pages: 188-197, ISSN: 0301-620X, and Jakopec M, Harris S J,
Rodriguez y Baena F, et al, The first clinical application of a
`Hands-On` robotic knee surgery system, Computer Aided Surgery,
2001, Vol: 6, Pages: 329-339, ISSN: 1092-9088, which are hereby
referenced in their entirety. Advancement of the milling guide 620
translational degree of freedom allows for the machining of
different contours in three dimensions, one plane at a time.
[0108] In one embodiment, the translational degree of freedom is
also motorized and sculpting of the bone can be accomplished in all
three dimensions instead of in successive planes. Additionally,
this translational degree of freedom can be arranged at an oblique
angle to the other rotational motorized degrees of freedom, so as
to improve the kinematics of milling and so that the milling tool
does not interfere with the bone surface. The use of inverse
kinematics models are known and commonly used in robotics to
control the milling path. Alternatively, more flexible control
schemes can also be used such as the ACROBOT control scheme
referenced above.
[0109] In FIG. 16, a milling device 700 has a curved side cutter
810 (curved profile) is illustrated and can be used to create a cut
surface that matches precisely the shape of the implant. For
example, this type of curved side cutter 810 is particularly
suitable for use in uni-condylar knee arthroplasty. In this
application, the motors 550 can be used to guide the trajectory
during cutting for milling of complex shapes, such as curves with
variable radii. It will be appreciated that the tool guide 620
allows positioning and locking of the milling tool 700 in the
medial-lateral direction to center the implant.
[0110] Milling cutters with inward curving implants can be used to
machine shapes approximating the original shape of the bone surface
to minimize the amount of bone being removed. FIG. 17 is a close-up
of a section of FIG. 16.
[0111] Alternatively and as shown in FIG. 18, a curved cutter 820
that only partially corresponds to the inner implant surface can be
used. One exemplary curved cutter 820 is a ball-shaped cutter.
Here, straight or curved cutting trajectories are machined into
successive planes that can be perpendicular to the two motor axes
520, 522 (FIG. 3). The surgeon can manually advance and lock the
milling device 700 to the next plane after the cut on the previous
plane is finished, by using the indexing system (notches 720) or by
using graduated markings on the milling attachment piece 620
(graduated marker system) or the navigation system 100 to advance
the cutting tool 700. The computer system 120 can be used to
control the positioning system 500 so as to adjust the milling
trajectory as a function of the contour plane level as measure by
the navigation system. In this embodiment, the notches 720 can be
closer together to obtain a better surface. The bone 2 can be
arranged so that the center of gravity is in line with the fixation
assembly 300 so as to minimize the moment acting on the fixation
pins 310 due to the weight of the system 100.
[0112] In another embodiment, the system can be used in an
end-milling configuration, so that the axis of the milling tool is
substantially perpendicular to the cutting surface. The axis of the
milling tool can be arranged such that is perpendicular to the axes
of rotation 520, 522. This could be particularly useful for cutting
curvilinear surfaces, such as those commonly used in
unicompartmental knee arthroplasty.
[0113] In any of the above embodiments the position of the cutting
tool with respect to the bone surface can be displayed in real
time. In particular the milling tool can be displayed with respect
the boundary of the cut, so that the surgeon known where they are
cutting with respect to the edge of the bone, and can pay
particular attention so as not to exit outside this boundary in
certain zones and injure soft tissues. In particular this boundary
can be displayed in different colors, for example, to distinguish
areas in which the model is more accurate then others. Accuracy can
be estimated by the number of points acquired in the region. Known
dangerous zones can also be highlighted, for example where vessels
or nerves typically are found.
[0114] The present system 100 provides a number of advantages.
Using at least one of the following: (1) the identified landmark
points; (2) the locations of the joints; (3) the relative bone
positions; and (4) the three dimensional shapes of the involved
bones, the system 100 can determine an optimal implant position
relative to the bone coordinate system 170. The following is merely
a list of additional features that can be incorporated into the
system 100 according to the present invention: using probe 160 to
navigate and check the location of two fixations pins 310 and the
anchor element 320 with respect to planned cuts to make sure they
do not intersect any cutting surfaces; a femoral rigid body can be
installed at the base of the orienting apparatus 400 to avoid
having to install additional pins in the bone 2 to fix the rigid
body; calibrating the axis of the milling tool 700 and the diameter
of its tip; tracking the milling tool 700 with respect to the bone
2 and displaying the milling tool 700 relative to the bone 2 and in
particular, relative to the boundaries of the cut; controlling the
milling tool speed as a function of the tool position in the bone;
providing a soft tissue guide on the milling tool 700;
incorporating an irrigation system in the tool 700 for spraying out
of the cutter bearing; and calibration systems for calibrating the
location of the robotic member; the angular index values of the
motors 550; and controlling the position of the motors 550 to align
the cutting guide to the implant plan. The present system 100 also
provides improved visibility by using only one, slender cutting
interface for all of the planar cuts in TKA; it provides a system
for positioning the saw-blade guide 610 at the start of the
posterior and anterior cuts; it provided an indexed milling tool
700 in which depth advancement of the cutting tool (mechanically
optionally) permits the efficient machining and decoupling of the
freedom; and it provides a passive cutting guide that allows the
surgeon to move a milling tool with a combination of at least one
rotation and one translation degree of freedom.
[0115] The system 100 can also be configured to measure the motion
of one bone in space, and to identify the centers of adjacent
joints from the measured trajectories. Furthermore, the system 100
can be configured to measure the motion of one bone relative to
another for various arcs of joint motion and degrees of joint
rotation. An IM bone plug can be made from bioabsorbable materials
and can be left in the bone. These bioabsorbable materials can
contain antibiotic type materials to prevent infection,
particularly in revision surgery. It can also serve as a cement
restrictor to prevent the cement from entering the intramedullary
canal.
[0116] The following example illustrates the use of the system 100
of the present invention in a typical surgical procedure.
EXAMPLE
[0117] Referring to FIG. 21, the robotic cutting guide of the
present invention was integrated into the Surgetics Station.RTM.,
distributed by the present assignee, which is an open platform
surgical navigation system that uses image-free BoneMorphing.RTM.
(deformable statistical) models to reconstruct the
three-dimensional shape of the femoral and tibial surface
intra-operatively.
[0118] The surgical workflow is present in FIG. 21. With reference
to FIGS. 2 and 21, first, the T and F rigid bodies 150, 140 are
fixed to the tibia 4 and the femur 2, respectively, and the point
probe "P" and planar guide probe "G" are calibrated. These rigid
bodies and probes each have at least three passive retro-reflective
markers that are localized in three-dimensional space by an optical
infrared camera.
[0119] To access the knee joint, a medial parapatellar approach
with a skin incision length of about 9.5 cm, which is approximately
two times the length of the patella. The incision is continued down
through the anterior joint capsule and patellofemoral ligament. A 2
cm snip in the vastus medialis in the direction of the fibers
facilitates the exposure along with resection of the tibial
meniscus and cruciate ligaments.
[0120] The tibial maleoli are first digitized to compute the ankle
center, followed by the tibial plateaus. These data determine the
initial attitude of the BoneMorphing model. The tibial surface
acquisitions are then made by manipulating the tibia with respect
to the femur in flexion, extension and rotation to help bring the
various bone areas into the incision. The patella was not reflected
by retracted or subluxed laterally. A conventional tibial cutting
guide was then navigated and secured to the anterior tibial surface
with two pins. The tibial cut was made with an oscillating saw, and
the final cut surface was measured with the planar "G" probe.
[0121] The femoral acquisition begins with kinematic identification
of the hip center without any rigid bodies in the pelvis. The
posterior condyles and Whiteside's line are then digitized followed
by the femoral BoneMorphing surface acquisition. Again, the tibia
is flexed, extended, and rotated relative to the femur to expose
the different femoral surface areas. There is now more space in the
knee as the tibial plateau has already been removed; the tibia can
be compressed against the femur and the patella can be distracted
laterally. A curved probe facilitates acquisition of the posterior
femoral areas with the knee in flexion, and the lateral areas with
the knee in extension. Once the surface acquisition is complete,
ligament gasp measurements between the uncut femoral condyles and
the tibial cut surface can be performed at various flexion angles
to optimize femoral component positioning and sizing. The system
then automatically suggests the optimal position and the size of
the femoral implant based on the mechanical axis, the bony landmark
features extracted from the BoneMorphing model, and the ligament
balancing acquisitions. This proposition can then be checked and
modified using the tactile display screen of the computer. Once the
femoral implant size and position have been validated, the
locations of the five cutting planes are stored in the femoral
coordinate system.
[0122] The robot fixation pins are then installed in the medial
femoral condyle using a guide to help keep the pins parallel and
separated by the appropriate distance. To assure that the pins do
not intersect any of the five cutting planes, each cutting plane
location, along with the position and orientation of the "P" probe,
are displayed in real time on the navigation screen. The insertion
site of the medial collateral ligament along with the planned
insertion points of the two fixation pins can be marked on the bone
surface to facilitate the insertion. The pin insertion area on the
medial side of the femur is bounded by the following structures:
anterodistally--by the anterior and anterior chamfer cuts;
distally--by the distal cutting plane; posteriorly--by the anterior
border of the medial collateral ligament when the knee is in full
extension; anterosuperiorly--by the posteroinferior border of the
vastus medians muscle when the knee is in flexion. Fixing the robot
in this area permitted uninhibited flexion and extension of the
knee, and access to all five cuts through the mobile incision.
[0123] 4 mm diameter, self tapping fixation pins were used without
drilling any pilot holes. The bone quality and density of the fresh
cadaver specimen we tested was relatively good, resulting in a
rigid and very satisfactory fixation. We are planning a study to
assess the rigidity of the two pin configuration in severely
osteoporotic bone, however, to see whether or not this fixation
technique is appropriate for all patients.
[0124] The gear unit with the pre-attached mechanical adjustment
system and cutting tool guide are then mounted onto the fixation
pins. With the calibrated planar probe ("G" rigid body) inserted in
the slot of the guide, robot axis is aligned in varus/valgus and
internal/external rotation using the numerical values displayed on
the navigation screen. Each degree of freedom can be navigated and
locked separately for ease-of-use. Once the adjustments are aligned
relative to the planned implant profile, the motor unit is attached
and the two kinematic axes and motor angles of the robot are
calibrated. This is accomplished by pressing the brake release
button on the 2 DOF gear unit, and manually rotating the first
robot axis through a range of motion of .about.90.degree..
Simultaneous measurement of the motor encoder values and of the "G"
rigid body locations with respect to the "F" femoral reference
frame are made using the motion controller and the optical camera,
respectively.
[0125] Using a simple inverse kinematic model that considers the
geometry of the robot and the mill or saw-guide, and the position
of each cutting plane relative to the robot kinematic axes and
encoder calibration constants, the system computes which motor
command values correspond to each of the five cutting planes. At
this point the robot motors are enabled and the guide can be
advanced to the first cut by pressing the system foot pedal and the
robot brake release button. The footswitch sends a command to the
motion controller to initiate motion of the motors, and the
controller monitors the encoder values, notifying the surgeon to
engage the mechanical brake once the guide is in position. In
addition, the planar guide probe can be inserted in the mill or
saw-guide slot to verify the guide position before making a
cut.
[0126] One preferred cutting order is (1) distal, (2) anterior
chamfer, (3) anterior, (4) posterior chamfer, (5) posterior. The
distal cut was chosen first in our surgical protocol because it
allows the surgeon to visually gauge overall varus/valgus and
internal/external rotational alignment, as well as distal cutting
depth, before making any of the femoral bone cuts. The anterior
chamfer cut was made next followed by the anterior cut so that the
cutting guide can be positioned directly against the start of the
cut for both cuts, which is an improvement over most over
conventional 4-in-1 and 5-in-1 types of cutting guides.sub.(3).
This becomes more important when using an oscillating saw, as
cutting accuracy is known to diminish with extension of the
saw-blade beyond the cutting guide. Moreover, making the anterior
cuts before the posterior ones could free more space in the joint
for making the posterior cut, which is more difficult due to the
position of the tibia and the delicate soft tissues behind the
knee. Although this is one preferred sequence, the cutting order is
not rigid and can be changed to suit surgeon preference. This is
quickly and easily accomplished by using the forward or back
switches on the system foot pedal to cycle through the cutting
sequence. After performing a resection, the accuracy of each cut
can be verified using the planar probe. These values are stored
into the digital surgical report at the end of the surgery.
[0127] While exemplary drawings and specific embodiments of the
present invention have been described and illustrated, it is to be
understood that the scope of the present invention is not to be
limited to the particular embodiments discussed. Thus, the
embodiments shall be regarded as illustrative rather than
restrictive, and it should be understood that variations may be
made in those embodiments by workers skilled in the art without
departing from the scope of the present invention as set forth in
the claims that follow, and equivalents thereof. In addition, the
features of the different points set forth below may be combined in
various ways in further accordance with the present invention.
* * * * *